Part II

As Enacted ( Federal Register)

Cited authorities 17

Cited in

Federal Register: November 19, 2008 (Volume 73, Number 224)

Rules and Regulations

Page 69725-70237

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr19no08-14

Page 69725

Part II

Book 2 of 2 Books

Pages 69725-70238

Department of Health and Human Services

Centers for Medicare & Medicaid Services

42 CFR Parts 405, 409, et al.

Medicare Program; Payment Policies Under the Physician Fee Schedule and

Other Revisions to Part B for CY 2009; E-Prescribing Exemption for

Computer-Generated Facsimile Transmissions; and Payment for Certain

Durable Medical Equipment, Prosthetics, Orthotics, and Supplies

(DMEPOS); Final Rule

Page 69726

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services 42 CFR Parts 405, 409, 410, 411, 413, 414, 415, 423, 424, 485, 486, and 489

CMS-1403-FC

CMS-1270-F2

RINs 0938-AP18, 0938-AN14

Medicare Program; Payment Policies Under the Physician Fee

Schedule and Other Revisions to Part B for CY 2009; E-Prescribing

Exemption for Computer-Generated Facsimile Transmissions; and Payment for Certain Durable Medical Equipment, Prosthetics, Orthotics, and

Supplies (DMEPOS)

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final rule with comment period.

SUMMARY: This final rule with comment period implements changes to the physician fee schedule and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. It also finalizes the calendar year (CY) 2008 interim relative value units (RVUs) and issues interim RVUs for new and revised codes for CY 2009. In addition, as required by the statute, it announces that the physician fee schedule update is 1.1 percent for CY 2009, the preliminary estimate for the sustainable growth rate for CY 2009 is 7.4 percent, and the conversion factor (CF) for CY 2009 is $36.0666. This final rule with comment period also implements or discusses certain provisions of the

Medicare Improvements for Patients and Providers Act of 2008 (MIPPA).

(See the Table of Contents for a listing of the specific issues addressed in this rule.)

DATES: Effective Date: This final rule with comment period is effective on January 1, 2009 except for amendments to Sec. 410.62 and Sec. 411.351 which are effective July 1, 2009.

Comment Date: Comments will be considered if we receive them at one of the addresses provided below, no later than 5 p.m. e.s.t. on

December 29, 2008.

ADDRESSES: In commenting, please refer to file code CMS-1403-FC.

Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

You may submit comments in one of four ways (no duplicates, please): 1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the instructions for

``Comment or Submission'' and enter the filecode to find the document accepting comments. 2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of

Health and Human Services, Attention: CMS-1403-FC, P.O. Box 8013,

Baltimore, MD 21244-8013.

Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services,

Department of Health and Human Services, Attention: CMS-1403-FC, Mail

Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. 4. By hand or courier. If you prefer, you may deliver (by hand or courier) your written comments (one original and two copies) before the close of the comment period to either of the following addresses: 7500 Security Boulevard, Baltimore, MD 21244-1850; or

Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW.,

Washington, DC 20201.

(Because access to the interior of the HHH Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)

Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.

Submission of comments on paperwork requirements. You may submit comments on this document's paperwork requirements by mailing your comments to the addresses provided at the end of the ``Collection of

Information Requirements'' section in this document.

For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT:

Pam West, (410) 786-2302, for issues related to practice expense.

Rick Ensor, (410) 786-5617, for issues related to practice expense methodology.

Stephanie Monroe, (410) 786-6864, for issues related to malpractice

RVUs.

Esther Markowitz, (410) 786-4595, for issues related to telehealth services.

Craig Dobyski, (410) 786-4584, for issues related to geographic practice cost indices.

Ken Marsalek, (410) 786-4502, for issues related to the multiple procedure payment reduction for diagnostic imaging.

Catherine Jansto, (410) 786-7762, or Cheryl Gilbreath, (410) 786- 5919, for issues related to payment for covered outpatient drugs and biologicals.

Edmund Kasaitis, (410) 786-0477, or Bonny Dahm, (410) 786-4006, for issues related to the Competitive Acquisition Program (CAP) for Part B drugs.

Corinne Axelrod, (410) 786-5620, for issues related to Health

Professional Shortage Area Bonus Payments.

Henry Richter, (410) 786-4562, for issues related to payments for end-stage renal disease facilities.

Lisa Grabert, (410) 786-6827, for issues related to hospital- acquired conditions and the Physician Resource Use Feedback Program.

August Nemec, (410) 786-0612, for issues related to independent diagnostic testing facilities; enrollment issues; and the revision to the ``Appeals of CMS or CMS contractor Determinations When a Provider or Supplier Fails To Meet the Requirements for Medicare Billing

Privileges'' final rule.

Lisa Ohrin, (410) 786-4565, Kristin Bohl, (410) 786-8680, or Don

Romano, (410) 786-1401, for issues related to anti-markup provisions and physician self-referral (incentive payment and shared savings programs).

Diane Stern, (410) 786-1133, for issues related to the quality reporting system for physician payment for CY 2009.

Andrew Morgan, (410) 786-2543, for issues related to the e- prescribing exemption for computer-generated fax transmissions.

Terri Harris, (410) 786-6830, for issues related to payment for comprehensive outpatient rehabilitation facilities (CORFs).

Lauren Oviatt, (410) 786-4683, for issues related to CORF conditions of coverage.

Trisha Brooks, (410) 786-4561, for issues related to personnel standards for portable x-ray suppliers.

David Walczak, (410) 786-4475, for issues related to beneficiary signature for nonemergency ambulance transport services.

Jean Stiller, (410) 786-0708, for issues related to the prohibition concerning providers of sleep tests

Mark Horney, (410) 786-4554, for issues related to the solicitation for comments and data pertaining to physician organ retrieval services.

Regina Walker-Wren, (410) 786-9160, for information concerning educational

Page 69727

requirements for nurse practitioners and clinical nurse specialists.

Randy Throndset, (410) 786-0131, for information concerning physician certification and recertification for Medicare home health services.

William Larson, (410) 786-4639, for coverage issues related to the initial preventive physical examination.

Cathleen Scally, (410) 786-5714, for payment issues related to the initial preventive physical examination.

Dorothy Shannon, (410) 786-3396, for issues related to speech language pathology.

Kendra Hedgebeth, (410) 786-4644, or Gina Longus, (410) 786-1287, for issues related to low vision aids.

Christopher Molling, (410) 786-6399, or Anita Greenberg, (410) 786- 4601, for issues related to the repeal to transfer of title for oxygen equipment.

Karen Jacobs, (410) 786-2173, or Hafsa Bora, (410) 786-7899, for issues related to the therapeutic shoes fee schedule.

Diane Milstead, (410) 786-3355, or Gaysha Brooks, (410) 786-9649, for all other issues.

SUPPLEMENTARY INFORMATION:

Submitting Comments: We welcome comments from the public on the following issues:

The Exception for Incentive Payment and Shared Savings

Programs (Sec. 411.357(x)) in section II.N.1. of this final rule with comment period;

Sections 131(c), 144(b), and 149 of the MIPPA as described in sections III.C., III.J., and III.M. of this final rule with comment period.

Interim Relative Value Units (RVUs) for selected codes identified in Addendum C;

Information on pricing for items in Tables 2 through 5;

Issues related to the Physician Resource Use Feedback

Program described in section II.S.6. of this final rule with comment period; and

The physician self-referral designated health services

(DHS) codes listed in Tables 29, 30, and 31. You can assist us by referencing the file code [CMS-1403-FC] and the section heading on which you choose to comment.

Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: http:// www.regulations.gov. Follow the search instructions on that Web site to view public comments.

Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the

Centers for Medicare & Medicaid Services, 7500 Security Boulevard,

Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.

Table of Contents

To assist readers in referencing sections contained in this preamble, we are providing a table of contents. Some of the issues discussed in this preamble affect the payment policies, but do not require changes to the regulations in the Code of Federal Regulations

(CFR). Information on the regulation's impact appears throughout the preamble, and therefore, is not exclusively in section XVI. of this final rule with comment period.

I. Background

A. Development of the Relative Value System 1. Work RVUs 2. Practice Expense Relative Value Units (PE RVUs) 3. Resource-Based Malpractice RVUs 4. Refinements to the RVUs 5. Adjustments to RVUs are Budget Neutral

B. Components of the Fee Schedule Payment Amounts

C. Most Recent Changes to Fee Schedule

II. Provisions of the Proposed Regulation

A. Resource-Based Practice Expense (PE) Relative Value Units

(RVUs) 1. Current Methodology 2. PE Proposals for CY 2009

B. Geographic Practice Cost Indices (GPCIs): Locality Discussion

C. Malpractice RVUs (TC/PC issue)

D. Medicare Telehealth Services

E. Specific Coding Issues Related to Physician Fee Schedule 1. Payment for Preadministration-Related Services for

Intravenous Infusion of Immune Globulin 2. Multiple Procedure Payment Reduction for Diagnostic Imaging 3. HCPCS Code for Prostate Saturation Biopsies

F. Part B Drug Payment 1. Average Sales Price (ASP) Issues 2. Competitive Acquisition Program (CAP) Issues

G. Application of the HPSA Bonus Payment

H. Provisions Related to Payment for Renal Dialysis Services

Furnished by End-Stage Renal Disease (ESRD) Facilities

I. Independent Diagnostic Testing Facility (IDTF) Issues

J. Physician and Nonphysician Practitioner (NPP) Enrollment

Issues

K. Amendment to the Exemption for Computer-Generated Facsimile

(FAX) Transmissions From the National Council for Prescription Drug

Programs (NCPDP) SCRIPT Standard for Transmitting Prescription and

Certain Prescription-Related Information for Part D Covered Drugs

Prescribed for Part D Eligible Individuals

L. Comprehensive Outpatient Rehabilitation Facilities (CORF) and

Rehabilitation Agency Issues

M. Technical Corrections for Therapy-Related Issues

N. Physician Self-Referral and Anti-Markup Issues 1. Exception for Incentive Payment and Shared Savings Programs

(Sec. 411.357(x)) 2. Changes to Reassignment Rules Related to Diagnostic Tests

(Anti-Markup Provisions)

O1. Physician Quality Reporting Initiative

O2. Electronic Prescribing (E-Prescribing) Incentive Program

P. Discussion of Chiropractic Services Demonstration

Q. Educational Requirements for Nurse Practitioners and Clinical

Nurse Specialists

R. Portable X-Ray Issue

S. Other Issues 1. Physician Certification (G0180) and Recertification (G0179) for Medicare-Covered Home Health Services Under a Home Health Plan of Care (POC) in the Home Health Prospective Payment System (HH PPS) 2. Prohibition Concerning Payment of Continuous Positive Airway

Pressure (CPAP) Devices 3. Beneficiary Signature for Nonemergency Ambulance Transport

Services 4. Solicitation of Comments and Data Pertaining to Physician

Organ Retrieval Services 5. Revision to the ``Appeals of CMS or CMS contractor

Determinations When a Provider or Supplier Fails To Meet the

Requirements for Medicare Billing Privileges'' Final Rule 6. Physician Resource Use Feedback Program

T. Electronic Prescribing (E-Prescribing) Incentive Program

III. Medicare Improvements for Patients and Providers Act of 2008

(MIPPA) Provisions

A. Section 101: Improvements to Coverage of Preventive Services

B. Section 131: Physician Payment, Efficiency, and Quality

Improvements

C. Section 131(c): Physician Resource Use Feedback Program

D. Section 132: Incentives for Electronic Prescribing

E. Section 133(b): Expanding Access to Primary Care Services

F. Section 134: Extension of Floor on Medicare Work Geographic

Adjustment Under the Medicare Physician Fee Schedule

G. Section 136: Extension of Treatment of Certain Physician

Pathology Services Under Medicare

H. Section 141: Extension of Exceptions Process for Medicare

Therapy Caps

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I. Section 143: Speech-Language Pathology Services

J. Section 144(b): Repeal of Transfer of Title for Oxygen

Equipment

K. Section 145: Clinical Laboratory Tests

L. Section 146: Improved Access to Ambulance Services

M. Section 149: Adding Certain Entities as Originating Sites for

Payment of Telehealth Services

N. Section 153: Renal Dialysis Provisions

IV. Potentially Misvalued Codes Under PFS

A. Valuing Services Under the Physician Fee Schedule

B. Requested Approaches for the AMA RUC To Utilize

C. AMA RUC Review of Potentially Misvalued Codes

V. Refinement of Relative Value Units for Calendar Year 2009 and

Response to Public Comments on Interim Relative Value Units for 2008

A. Summary of Issues Discussed Related to the Adjustment of

Relative Value Units

B. Process for Establishing Work Relative Value Units for the

Physician Fee Schedule

C. Interim 2008 Codes

D. Establishment of Interim Work Relative Value Units for New and Revised Physician's Current Procedural Terminology (CPT) Codes and New Healthcare Common Procedure Coding System Codes (HCPCS) for 2009 (Includes Table Titled ``AMA RUC Recommendations and CMS'

Decisions for New and Revised 2009 CPT Codes'')

E. Discussion of Codes and AMA RUC Recommendations

F. Additional Coding Issues

G. Establishment of Interim PE RVUs for New and Revised

Physician's Current Procedural Terminology (CPT) Codes and New

Healthcare Common Procedure Coding System (HCPCS) Codes for 2009

VI. Physician Self-Referral Prohibition: Annual Update to the List of CPT/HCPCS Codes

A. General

B. Speech-Language Pathology Services

C. Annual Update to the Code List

VII. Physician Fee Schedule Update for CY 2009

A. Physician Fee Schedule Update

B. The Percentage Change in the Medicare Economic Index (MEI)

C. The Update Adjustment Factor (UAF)

VIII. Allowed Expenditures for Physicians' Services and the

Sustainable Growth Rate (SGR)

A. Medicare Sustainable Growth Rate

B. Physicians' Services

C. Preliminary Estimate of the SGR for 2009

D. Revised Sustainable Growth Rate for 2008

E. Calculation of 2009, 2008, and 2007 Sustainable Growth Rates

IX. Anesthesia and Physician Fee Schedule Conversion Factors for CY 2009

A. Physician Fee Schedule Conversion Factor

B. Anesthesia Conversion Factor

X. Telehealth Originating Site Facility Fee Payment Amount Update

XI. Payment for Certain Durable Medical Equipment, Prosthetics,

Orthotics, and Supplies (DMEPOS)--Services Excluded From Coverage

A. Low Vision Aid Exclusion

B. Replacement of Reasonable Charge Methodology by Fee Schedules for Therapeutic Shoes

XII. Provisions of the Final Rule

XIII. Waiver of Proposed Rulemaking and Delay in Effective Date

XIV. Collection of Information Requirements

XV. Response to Comments

XVI. Regulatory Impact Analysis

Regulation Text

Addendum A--Explanation and Use of Addendum B

Addendum B--Relative Value Units and Related Information Used in

Determining Medicare Payments for CY 2009

Addendum C--Codes With Interim RVUs

Addendum D--2009 Geographic Adjustment Factors (GAFs)

Addendum E--2009 Geographic Practice Cost Indices (GPCIs) by State and Medicare Locality

Addendum F--Multiple Procedure Payment Reduction Code List

Addendum G--CY 2009 ESRD Wage Index for Urban Areas Based on CBSA

Labor Market Areas

Addendum H--CY 2009 ESRD Wage Index Based on CBSA Labor Market Areas for Rural Areas

Addendum I--CPT/HCPCS Imaging Codes Defined by Section 5102(b) of the DRA

Addendum J--List of CPT/HCPCS Codes Used To Define Certain

Designated Health Services Under Section 1877 of the Social Security

Act

Acronyms

In addition, because of the many organizations and terms to which we refer by acronym in this final rule with comment period, we are listing these acronyms and their corresponding terms in alphabetical order below:

ACC American College of Cardiology

ACR American College of Radiology

AFROC Association of Freestanding Radiation Oncology Centers

AHA American Heart Association

AHRQ [HHS] Agency for Healthcare Research and Quality

AIDS Acquired immune deficiency syndrome

AMA American Medical Association

AMP Average manufacturer price

AOA American Osteopathic Association

ASC Ambulatory surgical center

ASP Average sales price

ASRT American Society of Radiologic Technologists

ASTRO American Society for Therapeutic Radiology and Oncology

ATA American Telemedicine Association

AWP Average wholesale price

BBA Balanced Budget Act of 1997 (Pub. L. 105-33)

BBRA [Medicare, Medicaid and State Child Health Insurance Program]

Balanced Budget Refinement Act of 1999 (Pub. L. 106-113)

BIPA Medicare, Medicaid, and SCHIP Benefits Improvement Protection

Act of 2000 (Pub. L. 106-554)

BLS Bureau of Labor Statistics

BN Budget neutrality

CABG Coronary artery bypass graft

CAD Coronary artery disease

CAH Critical access hospital

CAHEA Committee on Allied Health Education and Accreditation

CAP Competitive acquisition program

CBSA Core-Based Statistical Area

CCHIT Certification Commission for Healthcare Information Technology

CEAMA Council on Education of the American Medical Association

CF Conversion factor

CfC Conditions for Coverage

CFR Code of Federal Regulations

CKD Chronic kidney disease

CLFS Clinical laboratory fee schedule

CMA California Medical Association

CMHC Community mental health center

CMP Civil money penalty

CMS Centers for Medicare & Medicaid Services

CNS Clinical nurse specialist

CoP Condition of participation

CORF Comprehensive Outpatient Rehabilitation Facility

CPAP Continuous positive air pressure

CPEP Clinical Practice Expert Panel

CPI Consumer Price Index

CPI-U Consumer price index for urban customers

CPT [Physicians'] Current Procedural Terminology (4th Edition, 2002, copyrighted by the American Medical Association)

CRT Certified respiratory therapist

CSW Clinical social worker

CY Calendar year

DHS Designated health services

DME Durable medical equipment

DMEPOS Durable medical equipment, prosthetics, orthotics, and supplies

DNP Doctor of Nursing Practice

DRA Deficit Reduction Act of 2005 (Pub. L. 109-171)

DSMT Diabetes self-management training

E/M Evaluation and management

EDI Electronic data interchange

EEG Electroencephalogram

EHR Electronic health record

EKG Electrocardiogram

EMG Electromyogram

EMTALA Emergency Medical Treatment and Active Labor Act

EOG Electro-oculogram

EPO Erythopoeitin

ESRD End-stage renal disease

FAX Facsimile

FDA Food and Drug Administration (HHS)

FFS Fee-for-service

FMS [Department of the Treasury's] Financial Management Service

FPLP Federal Payment Levy Program

FR Federal Register

GAF Geographic adjustment factor

GAO General Accounting Office

GPO Group purchasing organization

GPCI Geographic practice cost index

HAC Hospital-acquired conditions

HCPAC Health Care Professional Advisory Committee

HCPCS Healthcare Common Procedure Coding System

HCRIS Healthcare Cost Report Information System

Page 69729

HH PPS Home Health Prospective Payment System

HHA Home health agency

HHRG Home health resource group

HHS [Department of] Health and Human Services

HIPAA Health Insurance Portability and Accountability Act of 1996

(Pub. L. 104-191)

HIT Health information technology

HITSP Healthcare Information Technology Standards Panel

HIV Human immunodeficiency virus

HOPD Hospital outpatient department

HPSA Health Professional Shortage Area

HRSA Health Resources Services Administration (HHS)

ICF Intermediate care facilities

ICR Information collection requirement

IDTF Independent diagnostic testing facility

IFC Interim final rule with comment period

IPPS Inpatient prospective payment system

IRS Internal Revenue Service

IVIG Intravenous immune globulin

IWPUT Intra-service work per unit of time

JRCERT Joint Review Committee on Education in Radiologic Technology

MA Medicare Advantage

MA-PD Medicare Advantage-Prescription Drug Plans

MedCAC Medicare Evidence Development and Coverage Advisory Committee

(formerly the Medicare Coverage Advisory Committee (MCAC))

MedPAC Medicare Payment Advisory Commission

MEI Medicare Economic Index

MIEA-TRHCA Medicare Improvements and Extension Act of 2006 (that is,

Division B of the Tax Relief and Health Care Act of 2006 (TRHCA)

(Pub. L. 109-432)

MIPPA Medicare Improvements for Patients and Providers Act of 2008

(Pub. L. 110-275)

MMA Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173)

MMSEA Medicare, Medicaid, and SCHIP Extension Act of 2007 (Pub. L. 110-173)

MNT Medical nutrition therapy

MP Malpractice

MPPR Multiple procedure payment reduction

MQSA Mammography Quality Standards Act of 1992 (Pub. L. 102-539)

MRA Magnetic resonance angiography

MRI Magnetic resonance imaging

MS-DRG Medicare Severity-Diagnosis related group

MSA Metropolitan statistical area

NCD National Coverage Determination

NCPDP National Council for Prescription Drug Programs

NDC National drug code

NISTA National Institute of Standards and Technology Act

NP Nurse practitioner

NPDB National Practitioner Data Bank

NPI National Provider Identifier

NPP Nonphysician practitioner

NPPES National Plan and Provider Enumeration System

NQF National Quality Forum

NRC Nuclear Regulatory Commission

NTTAA National Technology Transfer and Advancement Act of 1995 (Pub.

L. 104-113)

NUBC National Uniform Billing Committee

OACT [CMS'] Office of the Actuary

OBRA Omnibus Budget Reconciliation Act

ODF Open door forum

OIG Office of Inspector General

OMB Office of Management and Budget

ONC [HHS'] Office of the National Coordinator for Health Information

Technology

OPPS Outpatient prospective payment system

OSA Obstructive Sleep Apnea

OSCAR Online Survey and Certification and Reporting

P4P Pay for performance

PA Physician assistant

PC Professional component

PCF Patient compensation fund

PDP Prescription drug plan

PE Practice expense

PE/HR Practice expense per hour

PEAC Practice Expense Advisory Committee

PECOS Provider Enrollment, Chain, and Ownership System

PERC Practice Expense Review Committee

PFS Physician Fee Schedule

PHP Partial hospitalization program

PIM [Medicare] Program Integrity Manual

PLI Professional liability insurance

POA Present on admission

POC Plan of care

PPI Producer price index

PPS Prospective payment system

PPTA Plasma Protein Therapeutics Association

PQRI Physician Quality Reporting Initiative

PRA Paperwork Reduction Act

PSA Physician scarcity areas

PSG Polysomnography

PT Physical therapy

ResDAC Research Data Assistance Center

RFA Regulatory Flexibility Act

RIA Regulatory impact analysis

RN Registered nurse

RNAC Reasonable net acquisition cost

RRT Registered respiratory therapist

RUC [AMA's Specialty Society] Relative (Value) Update Committee

RVU Relative value unit

SBA Small Business Administration

SGR Sustainable growth rate

SLP Speech-language pathology

SMS [AMA's] Socioeconomic Monitoring System

SNF Skilled nursing facility

SOR System of record

SRS Stereotactic radiosurgery

TC Technical Component

TIN Tax identification number

TRHCA Tax Relief and Health Care Act of 2006 (Pub. L. 109-432)

UPMC University of Pittsburgh Medical Center

USDE United States Department of Education

VBP Value-based purchasing

WAMP Widely available market price

I. Background

Since January 1, 1992, Medicare has paid for physicians' services under section 1848 of the Social Security Act (the Act), ``Payment for

Physicians' Services.'' The Act requires that payments under the physician fee schedule (PFS) be based on national uniform relative value units (RVUs) based on the relative resources used in furnishing a service. Section 1848(c) of the Act requires that national RVUs be established for physician work, practice expense (PE), and malpractice expense. Before the establishment of the resource-based relative value system, Medicare payment for physicians' services was based on reasonable charges.

A. Development of the Relative Value System 1. Work RVUs

The concepts and methodology underlying the PFS were enacted as part of the Omnibus Budget Reconciliation Act (OBRA) of 1989 (Pub. L. 101-239), and OBRA 1990, (Pub. L. 101-508). The final rule, published on November 25, 1991 (56 FR 59502), set forth the fee schedule for payment for physicians' services beginning January 1, 1992. Initially, only the physician work RVUs were resource-based, and the PE and malpractice RVUs were based on average allowable charges.

The physician work RVUs established for the implementation of the fee schedule in January 1992 were developed with extensive input from the physician community. A research team at the Harvard School of

Public Health developed the original physician work RVUs for most codes in a cooperative agreement with the Department of Health and Human

Services (DHHS). In constructing the code-specific vignettes for the original physician work RVUs, Harvard worked with panels of experts, both inside and outside the Federal government, and obtained input from numerous physician specialty groups.

Section 1848(b)(2)(B) of the Act specifies that the RVUs for anesthesia services are based on RVUs from a uniform relative value guide. We established a separate conversion factor (CF) for anesthesia services, and we continue to utilize time units as a factor in determining payment for these services. As a result, there is a separate payment methodology for anesthesia services.

We establish physician work RVUs for new and revised codes based on recommendations received from the American Medical Association's (AMA)

Specialty Society Relative Value Update Committee (RUC). 2. Practice Expense Relative Value Units (PE RVUs)

Section 121 of the Social Security Act Amendments of 1994 (Pub. L. 103-432),

Page 69730

enacted on October 31, 1994, amended section 1848(c)(2)(C)(ii) of the

Act and required us to develop resource-based PE RVUs for each physician's service beginning in 1998. We were to consider general categories of expenses (such as office rent and wages of personnel, but excluding malpractice expenses) comprising PEs.

Section 4505(a) of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33), amended section 1848(c)(2)(C)(ii) of the Act to delay implementation of the resource-based PE RVU system until January 1, 1999. In addition, section 4505(b) of the BBA provided for a 4-year transition period from charge-based PE RVUs to resource-based RVUs.

We established the resource-based PE RVUs for each physician's service in a final rule, published November 2, 1998 (63 FR 58814), effective for services furnished in 1999. Based on the requirement to transition to a resource-based system for PE over a 4-year period, resource-based PE RVUs did not become fully effective until 2002.

This resource-based system was based on two significant sources of actual PE data: the Clinical Practice Expert Panel (CPEP) data; and the

AMA's Socioeconomic Monitoring System (SMS) data. The CPEP data were collected from panels of physicians, practice administrators, and nonphysicians (for example, registered nurses (RNs)) nominated by physician specialty societies and other groups. The CPEP panels identified the direct inputs required for each physician's service in both the office setting and out-of-office setting. We have since refined and revised these inputs based on recommendations from the RUC.

The AMA's SMS data provided aggregate specialty-specific information on hours worked and PEs.

Separate PE RVUs are established for procedures that can be performed in both a nonfacility setting, such as a physician's office, and a facility setting, such as a hospital outpatient department. The difference between the facility and nonfacility RVUs reflects the fact that a facility typically receives separate payment from Medicare for its costs of providing the service, apart from payment under the PFS.

The nonfacility RVUs reflect all of the direct and indirect PEs of providing a particular service.

Section 212 of the Balanced Budget Refinement Act of 1999 (BBRA)

(Pub. L. 106-113) directed the Secretary of Health and Human Services

(the Secretary) to establish a process under which we accept and use, to the maximum extent practicable and consistent with sound data practices, data collected or developed by entities and organizations to supplement the data we normally collect in determining the PE component. On May 3, 2000, we published the interim final rule (65 FR 25664) that set forth the criteria for the submission of these supplemental PE survey data. The criteria were modified in response to comments received, and published in the Federal Register (65 FR 65376) as part of a November 1, 2000 final rule. The PFS final rules published in 2001 and 2003, respectively, (66 FR 55246 and 68 FR 63196) extended the period during which we would accept these supplemental data through

March 1, 2005.

In CY 2007 PFS final rule with comment period (71 FR 69624), we revised the methodology for calculating PE RVUs beginning in CY 2007 and provided for a 4-year transition for the new PE RVUs under this new methodology. We will continue to evaluate this policy and proposed necessary revisions through future rulemaking. 3. Resource-Based Malpractice (MP) RVUs

Section 4505(f) of the BBA amended section 1848(c) of the Act requiring us to implement resource-based malpractice (MP) RVUs for services furnished on or after 2000. The resource-based MP RVUs were implemented in the PFS final rule published November 2, 1999 (64 FR 59380). The MP RVUs were based on malpractice insurance premium data collected from commercial and physician-owned insurers from all the

States, the District of Columbia, and Puerto Rico. 4. Refinements to the RVUs

Section 1848(c)(2)(B)(i) of the Act requires that we review all

RVUs no less often than every 5 years. The first 5-Year Review of the physician work RVUs was published on November 22, 1996 (61 FR 59489) and was effective in 1997. The second 5-Year Review was published in the CY 2002 PFS final rule with comment period (66 FR 55246) and was effective in 2002. The third 5-Year Review of physician work RVUs was published in the CY 2007 PFS final rule with comment period (71 FR 69624) and was effective on January 1, 2007. (Note: Additional codes relating to the third 5-Year Review of physician work RVUs were addressed in the CY 2008 PFS final rule with comment period (72 FR 66360).)

In 1999, the AMA's RUC established the Practice Expense Advisory

Committee (PEAC) for the purpose of refining the direct PE inputs.

Through March 2004, the PEAC provided recommendations to CMS for over 7,600 codes (all but a few hundred of the codes currently listed in the

AMA's Current Procedural Terminology (CPT) codes). As part of the CY 2007 PFS final rule with comment period (71 FR 69624), we implemented a new methodology for determining resource-based PE RVUs and are transitioning this over a 4-year period.

In the CY 2005 PFS final rule with comment period (69 FR 66236), we implemented the first 5-Year Review of the MP RVUs (69 FR 66263). 5. Adjustments to RVUs are Budget Neutral

Section 1848(c)(2)(B)(ii)(II) of the Act provides that adjustments in RVUs for a year may not cause total PFS payments to differ by more than $20 million from what they would have been if the adjustments were not made. In accordance with section 1848(c)(2)(B)(ii)(II) of the Act, if adjustments to RVUs cause expenditures to change by more than $20 million, we make adjustments to ensure that expenditures do not increase or decrease by more than $20 million.

As explained in the CY 2007 PFS final rule with comment period (71

FR 69624), due to the increase in work RVUs resulting from the third 5-

Year Review of physician work RVUs, we applied a separate budget neutrality (BN) adjustor to the work RVUs for services furnished during 2007 and 2008. This approach is consistent with the method we used to make BN adjustments to reflect the changes in the PE RVUs.

Section 133(b) of the MIPPA amends section 1848(c)(2)(B) of the Act to specify that, instead of continuing to apply the BN adjustor for the 5-Year Review to work RVUs, the BN adjustment must be applied to the CF for years beginning with CY 2009. Further discussion of this MIPPA provision as it relates to the CY 2009 PFS can be found in sections

III. and IX. of this final rule with comment period.

B. Components of the Fee Schedule Payment Amounts

To calculate the payment for every physician's service, the components of the fee schedule (physician work, PE, and MP RVUs) are adjusted by a geographic practice cost index (GPCI). The GPCIs reflect the relative costs of physician work, PE, and malpractice insurance in an area compared to the national average costs for each component.

RVUs are converted to dollar amounts through the application of a

CF, which

Page 69731

is calculated by CMS' Office of the Actuary (OACT).

The formula for calculating the Medicare fee schedule payment amount for a given service and fee schedule area can be expressed as:

Payment = [(RVU work x GPCI work) + (RVU PE x GPCI PE) + (RVU malpractice x GPCI malpractice)] x CF.

C. Most Recent Changes to the Fee Schedule

The CY 2008 PFS final rule with comment period (72 FR 66222) addressed certain provisions of Division B of the Tax Relief and Health

Care Act of 2006--Medicare Improvements and Extension Act of 2006 (Pub.

L. 109-432) (MIEA-TRHCA), and made other changes to Medicare Part B payment policy to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services.

The CY 2008 PFS final rule with comment period also discussed refinements to resource-based PE RVUs; GPCI changes; malpractice RVUs; requests for additions to the list of telehealth services; several coding issues including additional codes from the 5-Year Review; payment for covered outpatient drugs and biologicals; the competitive acquisition program (CAP); clinical lab fee schedule issues; payment for end-stage renal dialysis (ESRD) services; performance standards for facilities; expiration of the physician scarcity area (PSA) bonus payment; conforming and clarifying changes for comprehensive outpatient rehabilitation facilities (CORFs); a process for updating the drug compendia; physician self-referral issues; beneficiary signature for ambulance transport services; durable medical equipment (DME) update; the chiropractic services demonstration; a Medicare economic index

(MEI) data change; technical corrections; standards and requirements related to therapy services under Medicare Parts A and B; revisions to the ambulance fee schedule; the ambulance inflation factor for CY 2008; and an amendment to the e-prescribing exemption for computer-generated facsimile transmissions.

We also finalized the calendar year (CY) 2007 interim RVUs and issued interim RVUs for new and revised procedure codes for CY 2008.

In accordance with section 1848(d)(1)(E)(i) of the Act, we also announced that the PFS update for CY 2008 is -10.1 percent, the preliminary estimate for the sustainable growth rate (SGR) for CY 2008 is -0.1 percent and the CF for CY 2008 is $34.0682. However, subsequent to publication of the CY 2008 PFS final rule with comment period, section 101(a) of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (Pub. L. 110-173) (MMSEA) was enacted on December 29, 2007 and provided for a 0.5 percent update to the conversion factor for the period beginning January 1, 2008 and ending June 30, 2008. For the first half of 2008 (that is, January through June), the Medicare PFS conversion factor was $38.0870. In the absence of legislation, the PFS conversion factor for the second half of 2008 would have been $34.0682, as announced in the PFS final rule with comment period for CY 2008.

However, as a result of the enactment of the Medicare Improvements for

Patients and Providers Act of 2008 (Pub. L. 110-275) (MIPPA), the

Medicare PFS conversion factor remained at $38.0870 for the remaining portion of 2008 (July through December).

II. Provisions of the Final Rule With Comment Period

In response to the CY 2009 PFS proposed rule (73 FR 38502) we received approximately 4,100 timely public comments. These included comments from individual physicians, health care workers, professional associations and societies, manufacturers and Congressmen. The majority of the comments addressed proposals related to independent diagnostic testing facilities, anti-markup, prohibition concerning providers of sleep tests, and the general impact of the proposed rule on specific specialties. To the extent that comments were outside the scope of the proposed rule, they are not addressed in this final rule with comment period.

A. Resource-Based Practice Expense (PE) Relative Value Units (RVUs)

Practice expense (PE) is the portion of the resources used in furnishing the service that reflects the general categories of physician and practitioner expenses, such as office rent and personnel wages but excluding malpractice expenses, as specified in section 1848(c)(1)(B) of the Act.

Section 121 of the Social Security Amendments of 1994 (Pub. L. 103- 432), enacted on October 31, 1994, required CMS to develop a methodology for a resource-based system for determining PE RVUs for each physician's service. Until that time, PE RVUs were based on historical allowed charges. This legislation stated that the revised PE methodology must consider the staff, equipment, and supplies used in the provision of various medical and surgical services in various settings beginning in 1998. The Secretary has interpreted this to mean that Medicare payments for each service would be based on the relative

PE resources typically involved with furnishing the service.

The initial implementation of resource-based PE RVUs was delayed from January 1, 1998, until January 1, 1999, by section 4505(a) of the

BBA. In addition, section 4505(b) of the BBA required that the new payment methodology be phased in over 4 years, effective for services furnished in CY 1999, and fully effective in CY 2002. The first step toward implementation of the statute was to adjust the PE values for certain services for CY 1998. Section 4505(d) of the BBA required that, in developing the resource-based PE RVUs, the Secretary must--

Use, to the maximum extent possible, generally-accepted cost accounting principles that recognize all staff, equipment, supplies, and expenses, not solely those that can be linked to specific procedures and actual data on equipment utilization.

Develop a refinement method to be used during the transition.

Consider, in the course of notice and comment rulemaking, impact projections that compare new proposed payment amounts to data on actual physician PE.

In CY 1999, we began the 4-year transition to resource-based PE

RVUs utilizing a ``top-down'' methodology whereby we allocated aggregate specialty-specific practice costs to individual procedures.

The specialty-specific PEs were derived from the American Medical

Association's (AMA's) Socioeconomic Monitoring Survey (SMS). In addition, under section 212 of the BBRA, we established a process extending through March 2005 to supplement the SMS data with data submitted by a specialty. The aggregate PEs for a given specialty were then allocated to the services furnished by that specialty on the basis of the direct input data (that is, the staff time, equipment, and supplies) and work RVUs assigned to each CPT code.

For CY 2007, we implemented a new methodology for calculating PE

RVUs. Under this new methodology, we use the same data sources for calculating PE, but instead of using the ``top-down'' approach to calculate the direct PE RVUs, under which the aggregate direct and indirect costs for each specialty are allocated to each individual service, we now utilize a ``bottom-up'' approach to calculate the direct costs. Under the ``bottom up'' approach, we determine the direct

PE by adding the costs of the resources (that is, the clinical staff, equipment, and supplies) typically required to provide each service.

The

Page 69732

costs of the resources are calculated using the refined direct PE inputs assigned to each CPT code in our PE database, which are based on our review of recommendations received from the AMA's Relative Value

Update Committee (RUC). For a more detailed explanation of the PE methodology see the June 29, 2006 proposed notice (71 FR 37242) and the

CY 2007 PFS final rule with comment period (71 FR 69629). 1. Current Methodology a. Data Sources for Calculating Practice Expense

The AMA's SMS survey data and supplemental survey data from the specialties of cardiothoracic surgery, vascular surgery, physical and occupational therapy, independent laboratories, allergy/immunology, cardiology, dermatology, gastroenterology, radiology, independent diagnostic testing facilities (IDTFs), radiation oncology, and urology are used to develop the PE per hour (PE/HR) for each specialty. For those specialties for which we do not have PE/HR, the appropriate PE/HR is obtained from a crosswalk to a similar specialty.

The AMA developed the SMS survey in 1981 and discontinued it in 1999. Beginning in 2002, we incorporated the 1999 SMS survey data into our calculation of the PE RVUs, using a 5-year average of SMS survey data. (See the CY 2002 PFS final rule with comment period (66 FR 55246)). The SMS PE survey data are adjusted to a common year, 2005.

The SMS data provide the following six categories of PE costs:

Clinical payroll expenses, which are payroll expenses

(including fringe benefits) for nonphysician clinical personnel.

Administrative payroll expenses, which are payroll expenses (including fringe benefits) for nonphysician personnel involved in administrative, secretarial, or clerical activities.

Office expenses, which include expenses for rent, mortgage interest, depreciation on medical buildings, utilities, and telephones.

Medical material and supply expenses, which include expenses for drugs, x-ray films, and disposable medical products.

Medical equipment expenses, which include depreciation, leases, and rent of medical equipment used in the diagnosis or treatment of patients.

All other expenses, which include expenses for legal services, accounting, office management, professional association memberships, and any professional expenses not previously mentioned in this section.

In accordance with section 212 of the BBRA, we established a process to supplement the SMS data for a specialty with data collected by entities and organizations other than the AMA (that is, those entities and organizations representing the specialty itself). (See the

Criteria for Submitting Supplemental Practice Expense Survey Data interim final rule with comment period (65 FR 25664)). Originally, the deadline to submit supplementary survey data was through August 1, 2001. In the CY 2002 PFS final rule (66 FR 55246), the deadline was extended through August 1, 2003. To ensure maximum opportunity for specialties to submit supplementary survey data, we extended the deadline to submit surveys until March 1, 2005 in the Revisions to

Payment Policies Under the Physician Fee Schedule for CY 2004 final rule with comment period (68 FR 63196) (hereinafter referred to as CY 2004 PFS final rule with comment period).

The direct cost data for individual services were originally developed by the Clinical Practice Expert Panels (CPEP). The CPEP data include the supplies, equipment, and staff times specific to each procedure. The CPEPs consisted of panels of physicians, practice administrators, and nonphysicians (for example, RNs) who were nominated by physician specialty societies and other groups. There were 15 CPEPs consisting of 180 members from more than 61 specialties and subspecialties. Approximately 50 percent of the panelists were physicians.

The CPEPs identified specific inputs involved in each physician's service provided in an office or facility setting. The inputs identified were the quantity and type of nonphysician labor, medical supplies, and medical equipment.

In 1999, the AMA's RUC established the PEAC. From 1999 to March 2004, the PEAC, a multi-specialty committee, reviewed the original CPEP inputs and provided us with recommendations for refining these direct

PE inputs for existing CPT codes. Through its last meeting in March 2004, the PEAC provided recommendations for over 7,600 codes which we have reviewed and in most instances have accepted. As a result, the current PE inputs differ markedly from those originally recommended by the CPEPs. The PEAC was replaced by the Practice Expense Review

Committee (PERC) and now these PE-related activities are addressed by the AMA RUC PE subcommittee. b. Allocation of PE to Services

The aggregate level specialty-specific PEs are derived from the

AMA's SMS survey and supplementary survey data. To establish PE RVUs for specific services, it is necessary to establish the direct and indirect PE associated with each service.

(i) Direct costs. The direct costs are determined by adding the costs of the resources (that is, the clinical staff, equipment, and supplies) typically required to provide the service. The costs of these resources are calculated from the refined direct PE inputs in our PE database. These direct inputs are then scaled to the current aggregate pool of direct PE RVUs. The aggregate pool of direct PE RVUs can be derived using the following formula: (PE RVUs x physician CF) x

(average direct percentage from SMS/(Supplemental PE/HR data)).

(ii) Indirect costs. The SMS and supplementary survey data are the source for the specialty-specific aggregate indirect costs used in our

PE calculations. We then allocate the indirect costs to the code level on the basis of the direct costs specifically associated with a code and the maximum of either the clinical labor costs or the physician work RVUs. For calculation of the 2009 PE RVUs, we use the 2007 procedure-specific utilization data crosswalked to 2009 services. To arrive at the indirect PE costs--

We apply a specialty-specific indirect percentage factor to the direct expenses to recognize the varying proportion that indirect costs represent of total costs by specialty. For a given service, the specific indirect percentage factor to apply to the direct costs for the purpose of the indirect allocation is calculated as the weighted average of the ratio of the indirect to direct costs (based on the survey data) for the specialties that furnish the service. For example, if a service is furnished by a single specialty with indirect

PEs that were 75 percent of total PEs, the indirect percentage factor to apply to the direct costs for the purposes of the indirect allocation would be (0.75/0.25) = 3.0. The indirect percentage factor is then applied to the service level adjusted indirect PE allocators.

We use the specialty-specific PE/HR from the SMS survey data, as well as the supplemental surveys for cardiothoracic surgery, vascular surgery, physical and occupational therapy, independent laboratories, allergy/immunology, cardiology, dermatology, radiology, gastroenterology, IDTFs, radiation oncology, and urology. (Note: For radiation oncology, the data represent

Page 69733

the combined survey data from the American Society for Therapeutic

Radiology and Oncology (ASTRO) and the Association of Freestanding

Radiation Oncology Centers (AFROC)). As discussed in the CY 2008 PFS final rule with comment period (72 FR 66233), the PE/HR survey data for radiology is weighted by practice size. We incorporate this PE/HR into the calculation of indirect costs using an index which reflects the relationship between each specialty's indirect scaling factor and the overall indirect scaling factor for the entire PFS. For example, if a specialty had an indirect practice cost index of 2.00, this specialty would have an indirect scaling factor that was twice the overall average indirect scaling factor. If a specialty had an indirect practice cost index of 0.50, this specialty would have an indirect scaling factor that was half the overall average indirect scaling factor.

When the clinical labor portion of the direct PE RVU is greater than the physician work RVU for a particular service, the indirect costs are allocated based upon the direct costs and the clinical labor costs. For example, if a service has no physician work and 1.10 direct PE RVUs, and the clinical labor portion of the direct

PE RVUs is 0.65 RVUs, we would use the 1.10 direct PE RVUs and the 0.65 clinical labor portions of the direct PE RVUs to allocate the indirect

PE for that service. c. Facility/Nonfacility Costs

Procedures that can be furnished in a physician's office as well as in a hospital or facility setting have two PE RVUs: facility and nonfacility. The nonfacility setting includes physicians' offices, patients' homes, freestanding imaging centers, and independent pathology labs. Facility settings include hospitals, ambulatory surgical centers (ASCs), and skilled nursing facilities (SNFs). The methodology for calculating PE RVUs is the same for both facility and nonfacility RVUs, but is applied independently to yield two separate PE

RVUs. Because the PEs for services provided in a facility setting are generally included in the payment to the facility (rather than the payment to the physician under the PFS), the PE RVUs are generally lower for services provided in the facility setting. d. Services With Technical Components (TCs) and Professional Components

(PCs)

Diagnostic services are generally comprised of two components: a professional component (PC) and a technical component (TC), both of which may be performed independently or by different providers. When services have TCs, PCs, and global components that can be billed separately, the payment for the global component equals the sum of the payment for the TC and PC. This is a result of using a weighted average of the ratio of indirect to direct costs across all the specialties that furnish the global components, TCs, and PCs; that is, we apply the same weighted average indirect percentage factor to allocate indirect expenses to the global components, PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum to the global under the bottom-up methodology.) e. Transition Period

As discussed in the CY 2007 PFS final rule with comment period (71

FR 69674), we are implementing the change in the methodology for calculating PE RVUs over a 4-year period. During this transition period, the PE RVUs will be calculated on the basis of a blend of RVUs calculated using our methodology described previously in this section

(weighted by 25 percent during CY 2007, 50 percent during CY 2008, 75 percent during CY 2009, and 100 percent thereafter), and the CY 2006 PE

RVUs for each existing code. PE RVUs for codes that are new during this period will be calculated using only the current PE methodology and will be paid at the fully transitioned rate. f. PE RVU Methodology

The following is a description of the PE RVU methodology.

(i) Setup File

First, we create a setup file for the PE methodology. The setup file contains the direct cost inputs, the utilization for each procedure code at the specialty and facility/nonfacility place of service level, and the specialty-specific survey PE per physician hour data.

(ii) Calculate the Direct Cost PE RVUs

Sum the costs of each direct input.

Step 1: Sum the direct costs of the inputs for each service. The direct costs consist of the costs of the direct inputs for clinical labor, medical supplies, and medical equipment. The clinical labor cost is the sum of the cost of all the staff types associated with the service; it is the product of the time for each staff type and the wage rate for that staff type. The medical supplies cost is the sum of the supplies associated with the service; it is the product of the quantity of each supply and the cost of the supply. The medical equipment cost is the sum of the cost of the equipment associated with the service; it is the product of the number of minutes each piece of equipment is used in the service and the equipment cost per minute. The equipment cost per minute is calculated as described at the end of this section.

Apply a BN adjustment to the direct inputs.

Step 2: Calculate the current aggregate pool of direct PE costs. To do this, multiply the current aggregate pool of total direct and indirect PE costs (that is, the current aggregate PE RVUs multiplied by the CF) by the average direct PE percentage from the SMS and supplementary specialty survey data.

Step 3: Calculate the aggregate pool of direct costs. To do this, for all PFS services, sum the product of the direct costs for each service from Step 1 and the utilization data for that service.

Step 4: Using the results of Step 2 and Step 3 calculate a direct

PE BN adjustment so that the aggregate direct cost pool does not exceed the current aggregate direct cost pool and apply it to the direct costs from Step 1 for each service.

Step 5: Convert the results of Step 4 to an RVU scale for each service. To do this, divide the results of Step 4 by the Medicare PFS

CF.

(iii) Create the Indirect PE RVUs

Create indirect allocators.

Step 6: Based on the SMS and supplementary specialty survey data, calculate direct and indirect PE percentages for each physician specialty.

Step 7: Calculate direct and indirect PE percentages at the service level by taking a weighted average of the results of Step 6 for the specialties that furnish the service. Note that for services with TCs and PCs we are calculating the direct and indirect percentages across the global components, PCs, and TCs. That is, the direct and indirect percentages for a given service (for example, echocardiogram) do not vary by the PC, TC and global component.

Step 8: Calculate the service level allocators for the indirect PEs based on the percentages calculated in Step 7. The indirect PEs are allocated based on the three components: the direct PE RVU, the clinical PE RVU, and the work RVU.

For most services the indirect allocator is: indirect percentage *

(direct PE RVU/direct percentage) + work RVU.

There are two situations where this formula is modified:

If the service is a global service (that is, a service with global, professional, and technical components), then the indirect allocator is: indirect percentage * (direct PE RVU/direct percentage) + clinical PE RVU + work RVU.

Page 69734

If the clinical labor PE RVU exceeds the work RVU (and the service is not a global service), then the indirect allocator is: indirect percentage * (direct PE RVU/direct percentage) + clinical PE

RVU.

(Note: For global services, the indirect allocator is based on both the work RVU and the clinical labor PE RVU. We do this to recognize that, for the professional service, indirect PEs will be allocated using the work RVUs, and for the TC service, indirect PEs will be allocated using the direct PE RVU and the clinical labor PE RVU. This also allows the global component RVUs to equal the sum of the PC and TC

RVUs.)

For presentation purposes in the examples in Table 1, the formulas were divided into two parts for each service. The first part does not vary by service and is the indirect percentage * (direct PE RVU/direct percentage). The second part is either the work RVU, clinical PE RVU, or both depending on whether the service is a global service and whether the clinical PE RVU exceeds the work RVU (as described earlier in this step.)

Apply a BN adjustment to the indirect allocators.

Step 9: Calculate the current aggregate pool of indirect PE RVUs by multiplying the current aggregate pool of PE RVUs by the average indirect PE percentage from the physician specialty survey data. This is similar to the Step 2 calculation for the direct PE RVUs.

Step 10: Calculate an aggregate pool of indirect PE RVUs for all

PFS services by adding the product of the indirect PE allocators for a service from Step 8 and the utilization data for that service. This is similar to the Step 3 calculation for the direct PE RVUs.

Step 11: Using the results of Step 9 and Step 10, calculate an indirect PE adjustment so that the aggregate indirect allocation does not exceed the available aggregate indirect PE RVUs and apply it to indirect allocators calculated in Step 8. This is similar to the Step 4 calculation for the direct PE RVUs.

Calculate the Indirect Practice Cost Index.

Step 12: Using the results of Step 11, calculate aggregate pools of specialty-specific adjusted indirect PE allocators for all PFS services for a specialty by adding the product of the adjusted indirect PE allocator for each service and the utilization data for that service.

Step 13: Using the specialty-specific indirect PE/HR data, calculate specialty-specific aggregate pools of indirect PE for all PFS services for that specialty by adding the product of the indirect PE/HR for the specialty, the physician time for the service, and the specialty's utilization for the service.

Step 14: Using the results of Step 12 and Step 13, calculate the specialty-specific indirect PE scaling factors as under the current methodology.

Step 15: Using the results of Step 14, calculate an indirect practice cost index at the specialty level by dividing each specialty- specific indirect scaling factor by the average indirect scaling factor for the entire PFS.

Step 16: Calculate the indirect practice cost index at the service level to ensure the capture of all indirect costs. Calculate a weighted average of the practice cost index values for the specialties that furnish the service. (Note: For services with TCs and PCs, we calculate the indirect practice cost index across the global components, PCs, and

TCs. Under this method, the indirect practice cost index for a given service (for example, echocardiogram) does not vary by the PC, TC and global component.)

Step 17: Apply the service level indirect practice cost index calculated in Step 16 to the service level adjusted indirect allocators calculated in Step 11 to get the indirect PE RVU.

(iv) Calculate the Final PE RVUs

Step 18: Add the direct PE RVUs from Step 6 to the indirect PE RVUs from Step 17.

Step 19: Calculate and apply the final PE BN adjustment by comparing the results of Step 18 to the current pool of PE RVUs. This final BN adjustment is required primarily because certain specialties are excluded from the PE RVU calculation for rate-setting purposes, but all specialties are included for purposes of calculating the final BN adjustment. (See ``Specialties excluded from rate-setting calculation'' below in this section.)

(v) Setup File Information

Specialties excluded from rate-setting calculation: For the purposes of calculating the PE RVUs, we exclude certain specialties such as midlevel practitioners paid at a percentage of the PFS, audiology, and low volume specialties from the calculation. These specialties are included for the purposes of calculating the BN adjustment.

Crosswalk certain low volume physician specialties:

Crosswalk the utilization of certain specialties with relatively low

PFS utilization to the associated specialties.

Physical therapy utilization: Crosswalk the utilization associated with all physical therapy services to the specialty of physical therapy.

Identify professional and technical services not identified under the usual TC and 26 modifiers: Flag the services that are PC and TC services, but do not use TC and 26 modifiers (for example, electrocardiograms). This flag associates the PC and TC with the associated global code for use in creating the indirect PE RVU. For example, the professional service code 93010 is associated with the global code 93000.

Payment modifiers: Payment modifiers are accounted for in the creation of the file. For example, services billed with the assistant at surgery modifier are paid 16 percent of the PFS amount for that service; therefore, the utilization file is modified to only account for 16 percent of any service that contains the assistant at surgery modifier.

Work RVUs: The setup file contains the work RVUs from this final rule.

(vi) Equipment Cost per Minute

The equipment cost per minute is calculated as:

(1/(minutes per year * usage)) * price * ((interest rate/(1-(1/((1 + interest rate) ** life of equipment)))) + maintenance)

Where: minutes per year = maximum minutes per year if usage were continuous

(that is, usage = 1); 150,000 minutes. usage = equipment utilization assumption; 0.5. price = price of the particular piece of equipment. interest rate = 0.11. life of equipment = useful life of the particular piece of equipment. maintenance = factor for maintenance; 0.05.

Note: To illustrate the PE calculation, in Table 1 we have used the conversion factor (CF) of $36.0666 which is the CF effective

January 1, 2009 as published in this final rule.

Page 69735

Table 1--Calculation of PE RVUs Under Methodology for Selected Codes

99213 Office

33533 CABG,

93000 ECG,

93005 ECG,

93010 ECG,

Step

Source

Formula

visit, est

arterial single 71020 Chest x- 71020TC Chest x- 7102026 Chest x-

complete

tracing

report nonfacility

facility

ray nonfacility ray nonfacility ray nonfacility

nonfacility

(1) Labor cost (Lab)........... Step 1.......... AMA............... .................

$13.32

$77.52

$5.74

$--

$6.12

$--

(2) Suppy cost (Sup)........... Step 1.......... AMA............... .................

$2.98

$7.34

$3.39

$--

$1.19

$--

(3) Equipment cost (Eqp)....... Step 1.......... AMA............... .................

$0.19

$0.65

$8.17

$--

$0.12

$--

(4) Direct cost (Dir).......... Step 1.......... .................. =(1)+(2)+(3).....

$16.50

$85.51

$17.31

$--

$7.43

$--

(5) Direct adjustment (Dir Adj) Steps 2-4....... See footnote*..... .................

0.625

(6) Adjusted labor............. Steps 2-4....... =Lab*Dir Adj...... =(1)*(5).........

$8.33

$48.48

$3.59

$--

$3.83

$--

(7) Adjusted supplies.......... Steps 2-4....... =Sup*Dir Adj...... =(2)*(5).........

$1.87

$4.59

$2.12

$--

$0.75

$--

(8) Adjusted equipment......... Steps 2-4....... =Eqp*Dir Adj...... =(3)*(5).........

$0.12

$0.41

$5.11

$--

$0.07

$--

(9) Adjusted direct............ Steps 2-4....... .................. =(6)+(7)+(8).....

$10.32

$53.48

$10.82

$--

$4.65

$--

(10) Conversion Factor (CF).... Step 5.......... MFS............... .................

36.0666

(11) Adj. labor cost converted. Step 5.......... =(Lab*Dir Adj)/CF. =(6)/(10)........

0.23

1.34

0.10

0.11

(12) Adj. supply cost converted Step 5.......... =(Sup*Dir Adj)/CF. =(7)/(10)........

0.05

0.13

0.06

0.02

(13) Adj. equip cost converted. Step 5.......... =(Eqp*Dir Adj)/CF. =(8)/(10)........

0.00

0.01

0.14

0.00

(14) Adj. direct cost converted Step 5.......... .................. =(11)+(12)+(13)..

0.29

1.48

0.30

0.13

(15) Wrk RVU................... Setup File...... MFS............... .................

0.92

33.64

0.22

0.17

(16) Dir--pct.................. Steps 6, 7...... Surveys........... .................

33.8%

32.6%

40.7%

37.7%

(17) Ind--pct.................. Steps 6, 7...... Surveys........... .................

66.2%

67.4%

59.3%

62.3%

(18) Ind. Alloc. formula (1st

Step 8.......... See Step 8........ ................. ((14)/(16))*(17) ((14)/(16))*(17) ((14)/(16))*(17) ((14)/(16))*(17) ((14)/(16))*(17) ((14)/(16))*(17) ((14)/(16))*(17) ((14)/(16))*(17) part).

(19) Ind. Alloc. (1st part).... Step 8.......... .................. See (18).........

0.56

3.06

0.44

0.21

(20) Ind. Alloc. formulas (2nd Step 8.......... .................. See Step 8.......

(15)

(15)+(11)

(11)

(15)

(15)+(11)

(11)

(15) part).

(21) Ind. Alloc. (2nd part).... Step 8.......... .................. See (20).........

0.92

33.64

0.32

0.10

0.22

0.28

0.11

0.17

(22) Indirect Allocator

Step 8.......... .................. =(19)+(21).......

1.48

36.70

0.76

0.54

0.22

0.49

0.32

0.17

(1st+2nd).

(23) Indirect Adjustment (Ind

Steps 9-11...... See footnote**.... .................

0.337

Adj).

(24) Adjusted Indirect

Steps 9-11...... =Ind Alloc * Ind

.................

0.50

12.37

0.26

0.18

0.07

0.16

0.11

0.06

Allocator.

Adj.

(25) Ind.Practice Cost Index

Steps 12-16..... See Steps 12-16 = .................

0.973

0.976

1.087

1.237

(PCI).

Adj. Ind.

(26) Adjusted Indirect......... Step 17......... Alloc*PCI......... =(24)*(25).......

0.49

12.07

0.28

0.20

0.08

0.20

0.13

0.07

(27) PE RVU.................... Steps 18-19..... =(Adj Dir+Adj Ind) =((14)+(26))

0.77

13.44

0.57

0.49

0.08

0.33

0.26

0.07

*budn.

Page 69736

2. PE Proposals for CY 2009 a. RUC Recommendations for Direct PE Inputs

In the CY 2009 PFS proposed rule, we agreed with the AMA RUC PE recommendations for 23 codes except for the inclusion of the clinical staff for quality-related activities for 8 immunization injection services (73 FR 38512). The AMA RUC recommendations and other PE issues are addressed below.

Immunization Services

We did not accept the AMA RUC-recommended inclusion of 4 minutes of clinical staff time related to quality activities (QA) for the 4 immunization codes for the initial injection: CPT codes 90465, 90467, 90471, and 90473; nor did we accept the recommended 1 minute of QA time for the 4 ``each additional'' subsequent injection for CPT codes 90466, 90468, 90472 and 90474. As we explained, unlike the clinical staff time related to quality activities that is included for mammography services as required by the Mammography Quality Standards Act of 1992 (Pub. L. 102-539) (MQSA), there is no statutory requirement for quality-related clinical staff time inputs for these services.

Comment: We received comments from individuals and group practice physicians, specialty societies, the AMA RUC, the AMA, two State medical societies, a vaccine manufacturer, a pharmaceutical research association, and the National Vaccine Advisory Committee regarding our omission of the QA clinical labor time for the immunization injection codes. These commenters requested that we add back the QA clinical time as recommended by the AMA RUC.

Response: Based on the commenters' requests, we reexamined the issue. We have identified clinical QA time included in other services that is not based on a statutory requirement. For many cardiac and vascular ultrasound services, for example, QA time is included because it is directly related to compliance with accreditation requirements.

After our review, we believe there was evidence to support the inclusion of this QA time in this case in order to comply with State and Federal regulatory guidelines. We have revised the PE database to reflect QA time for these immunization services.

Comment: Other commenters representing specialty societies supported our acceptance of the AMA RUC recommendations for the 15 other services identified in Table 2 of the proposed rule.

Response: We have finalized the AMA RUC PE recommendations for these services. b. Equipment Time-in-Use

The formula for estimating the cost per minute for equipment is based upon a variety of factors, including the cost of the equipment, useful life, interest rate, maintenance cost, and utilization. The purpose of this formula is to identify an estimated cost per minute for the equipment that can be multiplied by the time the equipment is in use to obtain an estimated per use equipment cost to develop the resource-based PE RVU.

In calculating the estimated cost per minute for services that are in use 24 hours per day for 7 days per week, we have assumed that the maximum amount of time that the equipment can be in use is approximately 525,000 minutes (that is, 525,000 minutes = (24 hours per day) x (7 days per week) x (52 weeks per year) x (60 minutes per hour)).

For CY 2008, we used 525,000 minutes to calculate the per minute equipment cost for the equipment used in CPT code 93012, Telephonic transmission of post-symptom electrocardiogram rhythm strip(s), 24-hour attended monitoring, per 30 day period of time; tracing only and CPT code 93271, Patient demand single or multiple event recording with presymptom memory loop, 24-hour attended monitoring, per 30 day period of time; monitoring, receipt of transmissions, and analysis. Based on information presented to us by a provider group suggesting that the equipment was in use continuously, we determined that this equipment is used 24 hours a day, 7 days a week. Thus, we assigned the equipment a 100 percent usage rate. However, in subsequent discussions with a provider group, we determined that, although there may be a 100 percent usage rate for a particular month, this does not correspond to a 100 percent usage rate for a year. Therefore, for CY 2009 we proposed to apply our standard utilization rate of 50 percent to the 525,000 maximum minutes of use, consistent with our utilization rate assumption for other equipment. This results in 262,500 minutes (that is, 262,500

= 525,000 x 0.50) of average use over the course of the year.

In the CY 2008 PFS rule, we used 43,200 minutes (60 minutes per hour x 24 hours per day x 30 days per month) to estimate the per use cost of the equipment in these monthly services. We are continuing to use 43,200 minutes in determining the equipment cost per use for these codes.

Comment: The majority of comments received supported our proposal to assign the standard 50 percent utilization rate to CPT codes 93012 and 93271. Other comments disagreed with our proposal and described it as an arbitrary method for changing equipment utilization rates. Many commenters suggested that we should develop a survey process that would obtain service specific utilization rates for all PFS services.

Response: We agree with the commenters that support assigning the standard 50 percent equipment utilization rate to CPT codes 93012 and 93271 and we will finalize our proposal to use the standard 50 percent utilization rate for CPT codes 93012 and 93271. Although we did not make any proposals related to a comprehensive survey of services specific equipment costs, we plan to continue to work with interested parties to analyze the possibilities for potential inclusion in a future rulemaking cycle. c. Change to PE Database Inputs for Certain Cardiac Stress Tests

In the CY 2009 PFS proposed rule, we proposed to change the PE database for CPT code 93025, Microvolt T-wave alternans for assessment of ventricular arrhythmias, to make the clinical labor staff type consistent with the other cardiac stress tests, CPT codes 93015 and 93017. In addition, we proposed to add the specific Microvolt T-wave testing equipment in place of the cardiac stress testing treadmill devices, as well as to revise the time-in-use for the equipment in CPT 93025 to reflect the service period. We also proposed to apply similar revisions to the equipment time-in-use to the other 2 CPT codes, CPT codes 93015 and 93017.

Comment: The manufacturer of the equipment technology and the specialty society were supportive of these proposed changes. In addition, the AMA RUC noted that it would address this issue at the 2008 October AMA RUC meeting.

Response: We have received and accepted the AMA RUC recommendations for CPT 93025, 93015 and 93017 which support all of the changes in our proposal. The PE database is revised to reflect these changes. d. Revisions to Sec. 414.22(b)(5)(i) Concerning Practice Expense

Current regulations at Sec. 414.22(b)(5)(i) provide an explanation of the two levels of PE RVUs for the facility and nonfacility settings that are used in determining payment under the PFS. Section 414.22(b)(5)(i)(A) discusses

Page 69737

facility PE RVUs and Sec. 414.22(b)(5)(i)(B) discusses nonfacility PE

RVUs. Language in each of these sections incorrectly implies that the facility PE RVU is lower than or equal to the nonfacility PE RVUs.

However, there are some instances where the facility PE RVUs may actually be greater than the nonfacility PE RVUs. In order to address this inaccuracy, we proposed to revise Sec. 414.22(b)(5)(i)(A) and (B) to remove this language.

We received no comments on our proposed technical change and have revised the regulations at Sec. 414.22(b)(5)(i)(A) and (B) as proposed. e. Other PE Direct Input Issues

(i) Removal of Conscious Sedation (CS) PE Inputs for Services in

Which CS is not Inherent--Technical Correction

In reviewing the PE database, we noted that the conscious sedation

(CS) PE inputs for 12 CPT codes in which CS is not inherent had not been removed after CPT 2005 began identifying these codes in a separate

Addendum. The CS inputs for CPT codes 19300, 22520, 22521, 31717, 62263, 62264, 62268, 62269, 63610, 64585, 64590, and 64595 had been added by the AMA RUC's PEAC prior to CY 2005. At that time, the AMA RUC recommended deletion of the CS PE inputs for all procedures that were not identified in the CPT 2005 manual Addendum which lists the services in which CS is inherent; and thus include the associated direct PE inputs. Due to a technical error, these inputs were not removed for CY 2005. We have removed the CS PE inputs for the 12 CPT codes noted above. We ask that the AMA RUC permit specialty societies to bring any

CPT codes forward to either the February or April 2009 AMA RUC meetings should any other discrepancies between the CPT Addendum and the PE database be identified.

(ii) Jejunostomy Tube Price

A comment received on the CY 2009 PFS proposed rule stated that we had mistakenly entered the price for a set of 2, rather than just 1, jejunostomy tube in each of the following CPT codes 49441, 49446, 49451, and 49452. So that the price of this PE supply can be properly valued as part of the PE RVUs for each of the four services in which it is found, we have changed the price of this supply from $198 to $97.50 in CPT codes 49441, 49446, 49451, and 49452. In addition, because it's correct price is less than $150, this item was erroneously placed on the list for re-pricing of higher-cost supplies on Table 29 in the proposed rule; and, as a result of this price correction, it has been removed from the list of supply items in need of repricing.

(iii) Supply Code SH079, Collagen, Dermal Implant (2.5ml uou)

(Contigen)

We received comments from a specialty society representing urologists noting that the dermal collagen implant, priced at $317, was an inappropriate supply input for CPT 52330. The specialty society asked that we remove this supply from this service. We agree that inclusion of the dermal collagen implant as a supply input for CPT code 52330 is not appropriate. The PE RVUs for CPT 52330 reflect the removal of this supply item.

(iv) Contractor Pricing of CPT 77371 for Stereotactic Radiosurgery

(SRS) Treatment Delivery

CPT code 77371, Radiation treatment delivery, stereotactic radiosurgery (SRS) (complete course of treatment of cerebral lesion(s) consisting of one session); multi-source Cobalt 60 based, (more commonly known as Gamma Knife) was a new CPT code for CY 2007. At that time, we accepted nearly all of the AMA RUC PE recommendations for this procedure (we did not accept the Cobalt 60 radiation source as a direct

PE input) during CY 2007 rulemaking, and these recommendations are reflected in the PE RVUs for CPT 77371. The PE inputs for CPT 77371 had been proposed by the sitting AMA RUC specialty society representing therapeutic radiation oncology physicians. The AMA RUC discussed and amended the specialty's proposal for direct PE inputs (particularly the amount of clinical labor time) prior to agreeing on the final AMA RUC recommendation that was forwarded to CMS for CY 2007. Due to the equipment expense (nearly $4 million) along with the many Nuclear

Regulatory Commission (NRC) requirements for construction of the facility required to furnish these procedures, all but one of these facilities is connected with a hospital setting, leaving a single free- standing nonfacility provider.

Comment: We received 3 comments stating that the PE RVUs listed in

Addendum B for CPT 77371 are exceptionally inadequate. All commenters, including the single freestanding nonfacility based provider, noted the difference in payments between those made under OPPS and the PFS for

CPT 77371. For CY 2009, the commenters noted that the proposed OPPS payment is $7,608 and the PFS payment under the proposed rule would be

$1,260. A freestanding nonfacility provider noted that it had worked with the Medicare contractor but was unsuccessful in securing a higher payment because the contractor could not deviate from the established

PE RVUs. Two commenters also stated that they believe the direct PE inputs are incorrect since the cost data they had gathered from other facility providers of this stereotactic radiosurgery (SRS) service included extra clinical labor time due to Nuclear Regulatory Commission

(NRC) requirements for both the physicist and the registered nurse. In addition, they disagreed with our decision to treat the Cobalt 60 radiation source (recommended by the AMA RUC as a 1-month renewable equipment item) as an indirect PE cost in the CY 2007 PFS final rule with comment period. The commenters have asked us to contractor-price

CPT 77371 for CY 2009 if a payment correction cannot be made in the final rule.

Response: We will ask the AMA RUC to review the direct PE inputs for this code in light of these comments. In the interim, we believe the commenters have raised sufficient questions regarding the propriety of the direct PE inputs and PE RVUs established for this new code in 2007 to warrant contractor-pricing for CPT 77371 for CY 2009. f. Supply and Equipment Items Needing Specialty Input

We have identified some supply and equipment items from the CY 2008 final rule with comment period for which we were unable to verify the pricing information (see Table 2: Items Needing Specialty Input for

Pricing and Table 3: Equipment Items Needing Specialty Input for

Pricing). For the items listed in Tables 2 and 3, we are requesting that commenters provide pricing information. In addition, we are requesting acceptable documentation, as described in the footnote to each table, to support the recommended prices. For supplies or equipment that previously appeared on these lists, we may propose to delete these items unless we receive adequate information to support current pricing by the conclusion of the comment period for this final rule.

In Tables 4 and 5, we have listed specific supplies and equipment items related to new CY 2009 CPT codes that are discussed in section V. of this final rule with comment period. We have added these items to the PE database along with the associated prices (on an interim basis).

We plan to propose finalized pricing information in the CY 2010 PFS proposed rule. Item prices identified in these tables are also reflected in the PE RVUs in Addendum B. In addition, we have asked commenters to submit specific information in response to the

Page 69738

discussion of the supply and equipment items for some each of the new

CPT codes in section V. of this final rule with comment period. We have also specifically asked for public comment about the direct cost inputs for the 3 new 2009 CPT codes which we contractor-priced for CY 2009

(CPT codes 93229, 93299, and 95803).

Table 2--Supply Items Needing Specialty Input for Pricing

Primary

Commenter

Code

2008/9

Unit

Associated

Associated *

Prior item status response and CMS 2009 Item status

Description

price

Specialties

CPT code(s)

on table

action

refer to note(s)

Gas, argon,

................. ........ Urology,

50395 YES................ New item 2008... A, D. cryoablation.

Radiology,

Interventional

Radiology.

Gas, helium,

................. ........ Urology,

50395 YES................ New item 2008... A, D. cryoablation.

Radiology,

Interventional

Radiology.

SL119....... Sealant spray.... oz............... ........ Radiation

77333 YES................ No comments

Oncology.

received.

Catheter, Kumpe.. Item............. ........ Radiology,

50385, 50386 YES................ New item 2008... A, D.

Interventional

Radiology.

Disposable

................. ........ Oral and

21073 YES................ New item 2008... A, D. aspirating

Maxillofacial syringe.

Surgery.

Guidewire, angle ................. ........ Radiology,

50385, 50386 YES................ New item 2008... A, D. tip (Terumo),

Interventional 180 cm.1

Radiology.

Snare, Nitinol

Item............. ........ Radiology,

50385, 50386 YES................ New item 2008... A, D.

(Amplatz).

Interventional

Radiology.

NA.......... Agent, neurolytic ml............... ........ Orthopedic

64632 NO................. New item 2009... A.

Surgery,

Podiatry.

NA.......... Strut,

Item.............

1151 ................

20697 NO................. New item 2009... A. replacement, dynamic external.

NA.......... Tube, anaerobic

Item............. ........ 62267...........

Lab NO................. New item 2009... A, B. culture.

NA.......... Tube,

Item.............

97.50 49441, 49446,

Accessory NO................. Price changed/

C. jejunsostomy.

49451 and 49452.

CMS error. $195 price for 2 J- tubes. $97.50 accepted.

Note: Acceptable documentation includes detailed description (including system, kit or product components), source (multiple sources requested), and current pricing information. For most items, there will be multiple sources of documentation available--multiple products/models that can be used as acceptable substitutes in performing a procedure. We ask that documentation from multiple sources be submitted with verified prices of the various products which represent the price range. In these instances, only one specific item/model/product is available on the market for use in a given procedure, one source of documentation is required. However, CMS expects that all documentation reflect the market price for each product reflecting the manufacturer or vendor discounts, rebates, etc. Invoices from physician purchases are the preferred documentation. In cases where this is not possible, CMS may accept other documentation such as copies of catalog pages, hard copy from specific Web pages, physician invoices, and typical or average sales price ``quotes'' (letter format okay) from manufacturers, vendors, or distributors. Unacceptable documentation includes phone numbers and addresses of manufacturer, vendors or distributors, Web site links without pricing information, etc.

A. Additional documentation required. Need detailed description (including ``kit'', system, or product contents and component parts), source, and current pricing information (including pricing per specified unit of measure in database).

B. No/Insufficient information received. Where applicable, retained price in database on an interim basis. Forward acceptable documentation promptly.

C. Submitted price accepted.

D. 2008/9 price retained on an interim basis. Forward acceptable documentation promptly.

Table 3--Equipment Items Needing Specialty Input for Pricing

* CPT 2008/9

Primary specialties

code(s)

Prior status on

Commenter response 2009 Item status

Code

2008/9 Description

Price associated with item associated

table

and CMS action

refer to note(s) with item

Camera mount-floor...

2300 Dermatology.........

96904 Yes................. Specialty to submit, A and D. asap.

Cross slide

500 Dermatology.........

96904 Yes................. Specialty to submit, A and D. attachment.

asap.

Plasma pheresis

37,900 Radiology,

36481, G0341 Yes................. Revised description B. machine.

Dermatology.

based on comments received that light source was not part of item.

Documentation requested.

ED039........... Psychology Testing

......... Psychology.......... 96101, 96102 Yes................. Specialty to submit, B.

Equipment.

asap.

Strobe, 400 watts

1500 Dermatology.........

96904 Yes................. Documentation

(Studio)(2).

requested.

Cryosurgery system

......... Urology, Radiology,

50593 Yes................. New item 2008....... A and D.

(for tumor

Interventional ablation).1

Radiology.

Page 69739

Workstation, dual,

85000 Cardiology..........

93351 No.................. New item 2009,

E. echocardiography.

Specialty submitted

$173,509--CMS accept $85,000.

EQ136........... Infrared Coagulator

3659.50 ....................

46606, No.................. New price for 2009

(with hand

46608,

with addition of applicator, includes

46610,

light guide, Supply light guide).

46612, 46930

code, Eq136, descriptor changed to include the light guide.

A. Additional documentation required. Need detailed description (including kit contents), source, and current pricing information (including pricing per specified unit of measure in database). Accept copies of catalog pages or hard copy from specific Web pages. Phone numbers or addresses of manufacturer, vendors, or distributors are not acceptable documentation.

B. No/Insufficient received. Retained price in database on an interim basis. Forward acceptable documentation promptly.

C. Submitted price accepted.

D. 2008/9 price, where specified, retained on an interim basis. Forward acceptable documentation promptly.

E. See discussion in section V. of this final rule with comment period. Forward requested documentation promptly, for example, whether item is typical.

Table 4--Practice Expense Supply Item Additions for CY 2009

* CPT code(s)

Equip code

Supply description

Unit

associated with

Supply category

Comments price

item

NA.............................. Agent, neurolytic.. ml................. ........ 64632.............. Pharmacy, Rx....... A, B and D.

NA.............................. IV infusion set,

Item...............

11.5 96369 and 96371.... Hypodermic, IV..... B.

Sof-set (Minimed).

NA.............................. Strut, replacement, Item............... 1151

20697.............. Accessory.......... A. dynamic external.

NA.............................. Swab, patient prep, Item...............

1.04 93352.............. Pharmacy, NonRx.... B. 1.5 ml

(chloraprep).

NA.............................. Tube, anaerobic

Item............... ........ 62267.............. Lab................ A. culture.

NA.............................. Tube, jejunsostomy. Item...............

97.50 49441, 49446, 49451 Accessory.......... A and C. and 49452.

A. Price verification needed. Item(s) added to table of supplies requiring specialty input.

B. Request explanation/rationale as to why specific supply is necessary, how it differs from current PE database item, and why current PE item(s) cannot be used for procedure(s).

C. CMS price correction.

D. Also, see discussion in section V. of this final rule with comment period. Proxy in use on an interim basis: SH062 Sclerosing solution, inj.

Table 5--Practice Expense Equipment Item Additions for CY 2009

* CPT code(s)

Supply or

Item code

Equipment

Equip Unit price associated with

equipment

Comments description

life

item

category

NA................ Workstation,

5 85000

93351........... DOCUMENTATION... A and D. dual, echocardiograph y.

NA................ Pacemaker,

5 123250

93693 and 93696. OTHER EQUIPMENT. B and D.

Interrogation,

System (CMS used Pacemaker,

Monitoring,

System as proxy for price).

Page 69740

EQ198............. Pacemaker follow-

7 23507

93279, 93280,

OTHER EQUIPMENT. C and D. up system (incl

93281, 93282, software and

93284, 93285, hardware)

93286, 93287,

(Paceart).

93288, 93289, 93290, 93291, 93292, 93724.

EQ136............. Infrared

3659.50 46606, 46608,

OTHER EQUIPMENT. A and D.

Coagulator

46610, 46612,

(with hand

46930. applicator, includes light guide).

Applicable FARS/DFARS apply.

A. Price verification needed. Item(s) added to table of equipment requiring specialty input.

B. Interim value, CY 2009 only. CMS assigned the pacemaker monitoring system to these two CPT codes that the specialty association requested a pacemaker ``interrogation'' system. Since the CMS PE database does not contain such an item, we assigned, on an interim basis, the pacemaker monitoring system that was assigned to these 2 codes previously. Although we remain uncertain as to the appropriate equipment that should be assigned, we will work with the specialty as they provide us with more information and documentation for the typical equipment needed for these 2 services when provided in the physician's office.

C. Interim value, CY 2009 only. CMS assigned EQ198 to all new cardiac monitoring codes for CY 2009 because the crosswalked codes (for CY 2008) each contained the equipment item EQ198. While the specialty requested the

``pacemaker monitoring system'' for these services, CMS was not provided any information to support the change in technology for these services provided in the physician's office setting.

D. Also, see discussion in Section V. of this final rule with comment period.

B. Geographic Practice Cost Indices (GPCI): Locality Discussion 1. Update

Section 1848(e)(1)(A) of the Act requires us to develop separate

Geographic Practice Cost Indices (GPCIs) to measure resource cost differences among localities compared to the national average for each of the three fee schedule components (work, PE and malpractice). While requiring that the PE and malpractice GPCIs reflect the full relative cost differences, section 1848(e)(1)(A)(iii) of the Act requires that the physician work GPCIs reflect only one-quarter of the relative cost differences compared to the national average.

Section 1848(e)(1)(C) of the Act requires us to review and, if necessary, adjust the GPCIs at least every 3 years. This section also specifies that if more than 1 year has elapsed since the last GPCI revision, we must phase in the adjustment over 2 years, applying only one-half of any adjustment in each year. As discussed in the CY 2008

PFS final rule with comment period (72 FR 66243), we established new

GPCIs for each Medicare locality in CY 2008 and implemented them. The

CY 2008 adjustment to the GPCIs reflected the first year of the 2-year phase-in.

We noted in the CY 2009 PFS proposed rule (73 FR 38513), that the physician work GPCIs we calculated did not reflect the 1.000 floor that was in place during CY 2006 through June 30, 2008. However, as discussed in section III. of this preamble, section 134 of the MIPPA of 2008 extended the 1.000 work GPCI floor from July 1, 2008, through

December 31, 2009. Additionally, section 134(b) of the MIPPA sets a permanent 1.500 work GPCI floor in Alaska for services furnished beginning January 1, 2009. As such, the CY 2009 GPCIs and summarized

GAFs reflect these statutorily mandated work GPCI floors.

See Addenda D and E for the CY 2009 GPCIs and summarized geographic adjustment factors (GAFs).

For a detailed explanation of how the GPCI update was developed, see the CY 2008 PFS final rule with comment period (72 FR 66244). 2. Payment Localities a. Background

As stated above in this section, section 1848(e)(1)(A) of the Act requires us to develop separate GPCIs to measure resource cost differences among localities compared to the national average for each of the three fee schedule components (work, PE, and malpractice).

Payments under the PFS are based on the relative resources required to provide services, and are adjusted for differences in resource costs among payment localities using the GPCIs. As a result, PFS payments vary between localities. Although the PFS payment for a particular service is actually adjusted by applying a GPCI to each fee schedule component, for purposes of discussion and comparison, we calculate a geographic adjustment factor (GAF) for each locality. These GAFs reflect a weighted average of the GPCIs within the locality and can be used as a general proxy for area practice costs. A GAF is calculated to reflect a summarization of the GPCIs, (which is used only to make comparisons across localities). The GAFs are not an absolute measure of actual costs, nor are they used to calculate PFS payments. Rather, they are a tool that can be used as a proxy for differences in the cost of operating a medical practice among various geographic areas (for example counties) for the purpose of assessing the potential impact of alternative locality configurations.

Prior to 1992, Medicare payments for physicians' services were made on the basis of reasonable charges. Payment localities were established under the reasonable charge system by local Medicare carriers based on their knowledge of local physician charging patterns and economic conditions. A total of 210 localities were developed; including 22

``Statewide'' localities where all areas within a State (whether urban or rural) received the same payment amount for a given service. These localities changed little between the inception of Medicare in 1966 and the beginning of the PFS in 1992. Following the inception of the PFS, we acknowledged that there was no consistent geographic basis for these localities and that they did not reflect the significant economic and demographic changes that had taken place since 1966. As a result, a study was begun in 1994 which culminated in a comprehensive locality revision which was implemented in 1997.

The 1997 payment locality revision was based and built upon the prior locality structure. The 22 previously existing Statewide localities remained Statewide localities. New localities were established in the remaining 28 States by comparing the area cost differences (using the GAFs as a proxy for costs) of the localities within these States. We ranked the existing localities within these

States by GAFs in descending order. The GAF of the highest locality

Page 69741

within a State was compared to the weighted average GAF of other localities. If the differences between these GAFs exceeded 5 percent, the highest locality remained a distinct locality. If the GAFs associated with all the localities in a State did not vary by at least 5 percent, the State became a Statewide locality. If the highest locality remained a distinct locality, the process was repeated for the second highest locality and so on until the variation among remaining localities fell below the 5 percent threshold. The rest of the localities within the State were combined into a single rest-of-State locality as their costs were relatively homogeneous. The revised locality structure (which is the one currently in use) reduced the number of localities from 210 to 89. The number of Statewide localities increased from 22 to 34. The development of the current locality structure is described in detail in the CY 1997 PFS proposed rule (61

FR 34615) and the subsequent final rule (61 FR 59494).

Although there have been no changes to the locality structure since 1997, we have proposed changes in recent years, although we did not finalize them. As we have frequently noted, any changes to the locality configuration must be made in a budget neutral manner. Therefore, changes in localities can lead to significant redistributions in payments. For many years, we have not considered making changes to localities without the support of a State Medical Association, which we believed would demonstrate consensus for the change among the professionals who would be affected. However, we recognize that over time changes in demographics or local economic conditions may lead us to conduct a more comprehensive examination of existing payment localities, and consideration of potential alternatives.

Payment Locality Approaches Discussed in the CY 2008 PFS Proposed Rule

For the past several years, we have been involved in discussions with California physicians and their representatives about recent shifts in relative demographics and economic conditions among a number of counties within the current California payment locality structure.

In the CY 2008 PFS proposed rule, we described three options for changing the payment localities in California. For a detailed discussion of the options for changing the payment localities in

California, see the CY 2008 PFS proposed rule and final rule with comment period (72 FR 38139 and 72 FR 66245, respectively).

After evaluating the comments on these options, which included

MedPAC's two suggestions for developing changes in payment localities for the entire country (not just California), other States expressing interest in having their payment localities reconfigured, and the

California Medical Association's decision not to endorse any option, we decided not to proceed with any of the alternatives we presented. We explained in the CY 2008 final rule with comment period (72 FR 66248) that we intended to conduct a thorough analysis of potential approaches to reconfiguring localities and would address this issue again in future rulemaking. We also noted that some commenters wanted us to consider a national reconfiguration of localities rather than just making changes one State at a time. b. Alternative Payment Locality Approaches

In the CY 2009 PFS proposed rule, we explained that as a follow-up to the CY 2008 PFS final rule with comment period, we contracted with

Acumen, LLC to conduct a preliminary study of several options for revising the payment localities. To that end, we are currently reviewing several alternative approaches for reconfiguring payment localities on a nationwide basis. However, our study of possible alternative payment locality configurations is in the early stages of development. We also stated that we are not making any changes to our payment localities at this time. For a discussion of the alternative payment locality configurations currently under consideration, see the

CY 2009 PFS proposed rule (73 FR 38514).

Our preliminary study of several options for revising the payment localities was posted on the CMS Web site on August 21, 2008. The report entitled, ``Review of Alternative GPCI Payment Locality

Structures'', which was produced by Acumen, LLC under contract to CMS, is accessible from the PFS Federal regulation notices Web page under the download section of the CY 2009 PFS proposed rule (CMS-1403-P). The report may also be accessed directly from the following link: http:// www.cms.hhs.gov/PhysicianFeeSched/downloads/ReviewOfAltGPCIs.pdf.

Comments on the interim report were accepted through November 3, 2008.

In the CY 2009 PFS proposed rule and on the CMS Web site, we encouraged interested parties to submit comments on the options presented in the proposed rule and in our interim report. We also requested comments on the administrative and operational issues associated with each option, as well as suggestions for other options.

Comment: We received comments on the options discussed in the proposed rule from various specialty groups and medical societies, as well as a few group practices and individual practitioners. Generally, commenters commended us for acknowledging the need for intermittent reconfiguration of PFS payment localities and expressed support for our study of alternative locality configurations. Some commenters urged us to expedite changes in our payment localities and suggested that we do so as part of the CY 2009 final rule. Other commenters requested that, in any locality reconfiguration, we minimize the payment discrepancy between urban and rural areas to ensure continued access to care.

Response: We would like to thank the public for the comments submitted on the options presented in the proposed rule and in the interim report posted on the CMS Web site. We will summarize all comments received in future rulemaking. As we have stated previously, we will provide extensive opportunities for public comment (for example, town hall meetings or open door forums, as well as a proposed rule) on any specific proposals for changes to the locality configuration before implementing any changes.

C. Malpractice RVUs (PC/TC Issue)

In the CY 1992 PFS final rule (56 FR 59527), we described in detail how malpractice (MP) RVUs are calculated for each physicians' service and, when professional liability insurance (PLI) premium data are not available, how we crosswalk or assign RVUs to services. Following the initial calculation of resource-based MP RVUs, the MP RVUs are then subject to review by CMS at 5-year intervals. Reviewing the MP RVUs every 5 years ensures that the MP relative values reflect any marketplace changes in the physician community's ability to acquire

PLI. However, there are codes that define certain radiologic services that have never been part of the MP RVU review process. The MP RVUs initially assigned to these codes have not been revised because there is a lack of suitable data on the cost of PLI for technical staff or imaging centers (where most of these services are performed).

In the CY 2008 PFS proposed rule (72 FR 38143), we noted that the

PLI workgroup, a subset of the Relative Value Update Committee (RUC) of the AMA, brought to our attention the fact that there are approximately 600 services that have TC MP RVUs that are

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greater than the PC MP RVUs. The PLI workgroup requested that we make changes to these MP RVUs and suggested that it is illogical for the MP

RVUs for the TC of a service to be higher than the MP RVUs for the PC.

We responded that we would like to develop a resource-based methodology for the technical portion of these MP RVUs; but that we did not have data to support such a change. We asked for information about how, and if, technicians employed by facilities purchase PLI or how their professional liability is covered. We also asked for comments on what types of PLI are carried by facilities that perform these technical services.

In the CY 2008 PFS final rule with comment period (72 FR 66248), one commenter suggested that we ``flip'' the MP RVUs between the PCs and TCs, or make them equal. Reversing the RVUs would reduce the MP

RVUs for the TC and increase the MP RVUs for the PC. The AMA's PLI workgroup recommended that we reduce the MP RVUs for the TC for these codes to zero. The workgroup suggested that there are no identifiable separate costs for professional liability for the TC. The workgroup also recommended that the MP RVUs removed from the TC for these codes be redistributed across all physicians' services.

We responded that we did not believe it would be appropriate to

``flip'' the PC and TC MP RVU values because the professional part of the MP RVUs has undergone a resource-based review, is derived from actual data, and is consistent with the resource-based methodology for

PFS payments. We stated that we would not simply equalize the PC and TC

RVU values because we had no data to demonstrate that the MP costs for the technical portion of these services are the same as the professional portion.

We also noted that we have received several comments supporting the decision to examine the possibility of developing a resource-based methodology for the technical portion of the MP RVUs. The commenters supported the collection and analysis of appropriate MP premium data before making any changes to the MP RVU distribution.

We stated that we would continue to solicit, collect, and analyze appropriate data on this subject. We noted that when we had sufficient information we would be better able to make a determination as to what, if any, changes should be made and that we would propose any changes in future rulemaking.

In the CY 2009 PFS proposed rule (73 FR 38515), we stated that the issue of assigning MP RVUs for the TC of certain services continues to be a source of concern for several physician associations and for CMS.

We noted that we did not receive a response to our CY 2008 request for additional data on this issue and that this issue is one of importance to CMS. We also stated that the lack of available PLI data affects our ability to make a resource-based evaluation of the TC MP RVUs for these codes. We indicated that as part of our work to update the MP RVUs in

CY 2010, we would instruct our contractor to research available data sources for the MP costs associated with the TC portion of these codes and that we would also ask the contractor to look at what is included in general liability insurance versus PLI for physicians and other professional staff. We also stated that if data sources are available, we would instruct the contractor to gather the data so we will be ready to implement revised MP RVUs for the TC of these codes in conjunction with the update of MP RVUs for the PCs in 2010.

The following is a summary of the comments we received on the CY 2009 PFS proposed rule and our responses.

Comment: Most commenters opposed any change to the MP RVUs that would make the TC MP RVUs zero. The commenters stated that there are identifiable MP expenses associated with allied health professionals and that for many radiation oncology centers there are separate MP insurance policies for the radiation oncologists and the nonphysician clinical personnel. The commenters requested that we ensure that the liability insurance associated with the nonphysician personnel is reflected in the MP RVUs for technical services. The commenters also stated that these expenses do not represent general insurance liability premiums which are part of the PE RVUs. The commenters were supportive of our plan for researching data sources for MP premium data for the TC of these codes. One commenter provided the name of a company that provides liability insurance to imaging facilities.

Other commenters, including the AMA, proposed that CMS reduce to zero the TC MP RVUs associated with the codes identified as having higher TC MP RVUs than PC MP RVUs. The commenters stated that any premium data received would represent general liability insurance, not liability insurance premium data related to nonphysician clinical personnel. The commenters suggested that premium data does not exist to support a resource-based computation of the MP RVUs for the TC and stated that general liability insurance premiums are included in the PE component and should not be part of the MP RVU calculation.

Response: We appreciate the comments in support of our proposal to instruct our contractor to research available data sources for the MP costs associated with the TC portions of these codes. As we stated in the CY 2008 PFS final rule with comment period (72 FR 66248), we are not able to evaluate whether sufficient data exists or to make a judgment on the RUC's assertion that such data are not available. It is possible that the contractor responsible for collecting the data for the 5-year MP RVU update will identify providers of professional liability insurance for nonphysician clinical personnel. We plan to share the information received on a potential source of such data with our contractor. If such premium data can be identified, it will be incorporated into the MP RVU update. In the event that we adopt such data, we will ensure there is no duplication of costs between the PE and the MP RVUs. As noted in the CY 2009 PFS proposed rule, and discussed above in this section, we will be addressing this issue as part of the update to the malpractice RVUs for CY 2010.

D. Medicare Telehealth Services 1. Requests for Adding Services to the List of Medicare Telehealth

Services

Section 1834(m)(4)(F) of the Act defines telehealth services as professional consultations, office visits, and office psychiatry services, and any additional service specified by the Secretary. In addition, the statute required us to establish a process for adding services to or deleting services from the list of telehealth services on an annual basis.

In the December 31, 2002 Federal Register (67 FR 79988), we established a process for adding services to or deleting services from the list of Medicare telehealth services. This process provides the public an ongoing opportunity to submit requests for adding services.

We assign any request to make additions to the list of Medicare telehealth services to one of the following categories:

Category 1: Services that are similar to professional consultations, office visits, and office psychiatry services. In reviewing these requests, we look for similarities between the proposed and existing telehealth services for the roles of, and interactions among, the beneficiary, the physician (or other practitioner) at the distant site

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and, if necessary, the telepresenter. We also look for similarities in the telecommunications system used to deliver the proposed service, for example, the use of interactive audio and video equipment.

Category 2: Services that are not similar to the current list of telehealth services. Our review of these requests includes an assessment of whether the use of a telecommunications system to deliver the service produces similar diagnostic findings or therapeutic interventions as compared with the face to face ``hands on'' delivery of the same service. Requestors should submit evidence showing that the use of a telecommunications system does not affect the diagnosis or treatment plan as compared to a face to face delivery of the requested service.

Since establishing the process, we have added the following to the list of Medicare telehealth services: psychiatric diagnostic interview examination; ESRD services with two to three visits per month and four or more visits per month (although we require at least one visit a month to be furnished in-person ``hands on'', by a physician, clinical nurse specialist (CNS), nurse practitioner (NP), or physician assistant

(PA) to examine the vascular access site); individual medical nutrition therapy; and the neurobehavioral status exam.

Requests to add services to the list of Medicare telehealth services must be submitted and received no later than December 31 of each calendar year to be considered for the next rulemaking cycle. For example, requests submitted before the end of CY 2007 are considered for the CY 2009 proposed rule. Each request for adding a service to the list of Medicare telehealth services must include any supporting documentation you wish us to consider as we review the request. Because we use the annual PFS as a vehicle for making changes to the list of

Medicare telehealth services, requestors should be advised that any information submitted is subject to disclosure for this purpose. For more information on submitting a request for an addition to the list of

Medicare telehealth services, including where to directly mail these requests, visit our Web site at http://www.cms.hhs.gov/telehealth/. 2. Submitted Requests for Addition to the List of Telehealth Services

We received the following requests in CY 2007 for additional approved services to become effective for CY 2009: (1) Diabetes self- management training (DSMT); and (2) critical care services. In addition, in the CY 2008 PFS final rule with comment period (72 FR 66250), we committed to continuing to evaluate last year's request to add subsequent hospital care to the list of approved telehealth services. In the CY 2009 PFS proposed rule (73 FR 38515), we responded to these requests. We did not propose to add DSMT or critical care services to the list of Medicare telehealth services. We proposed to create HCPCS codes specific to follow-up inpatient consultations delivered via telehealth, and we proposed to revise Sec. 410.78 and

Sec. 414.65 to revise our regulations accordingly. The following is a summary of the discussion from the proposed rule and a summary of the comments we received and our responses. a. Diabetes Self-Management Training (DSMT)

The American Telemedicine Association (ATA) and the Marshfield

Clinic submitted a request to add individual and group diabetes self management training (DSMT) (as represented by Healthcare Common

Procedure Coding System (HCPCS) codes G0108 and G0109) to the list of approved telehealth services. The requesters believe that DSMT services can be considered and approved for telehealth as Category 1 services because they are comparable to medical nutrition therapy (MNT) services approved for telehealth.

As discussed in the CY 2009 PFS proposed rule (73 FR 38516), Sec. 414.65 provides for the payment of individual MNT furnished via telehealth. Group MNT is not an approved telehealth service, so it cannot be used as a point of comparison for group DSMT (as represented by HCPCS code G0109). In addition, group counseling services have a different interactive dynamic between the physician or practitioner at the distant site and beneficiary at the originating site as compared to services on the current list of Medicare telehealth services. (See 70

FR 45787 and 70 FR 70157 for a previous discussion of group services.)

Since the interactive dynamic of group DSMT is not similar to individual MNT or any other service currently approved for telehealth, we believe that group DSMT must be evaluated as a category 2 service.

Section 1861(qq) of the Act provides that DSMT (which can be either a group or individual service) involves educational and training services to ensure therapy compliance or to provide necessary skills and knowledge to participate in managing the condition, including the skills necessary for the self administration of injectable drugs. We believe individual DSMT is not analogous to individual MNT because of the element of skill based training that is encompassed within individual DSMT, but is not an aspect of individual MNT (or any other services currently approved for telehealth). Due to the statutory requirement that DSMT services include teaching beneficiaries the skills necessary for the self administration of injectable drugs, we believe that DSMT, whether provided to an individual or a group, must be evaluated as a category 2 service.

Because we consider individual and group DSMT to be category 2 services, we needed to evaluate whether these are services for which telehealth can be an adequate substitute for a face to face encounter.

After reviewing studies submitted with the request, we determined that we do not have sufficient comparative analysis that either individual or group DSMT delivered via telecommunications is equivalent to DSMT delivered face to face. We did not find evidence that providing DSMT via telehealth is an adequate substitute for providing DSMT in person.

Therefore, we proposed not to add individual and group DSMT (as described by HCPCS codes G0108 and G0109) to the list of approved telehealth services.

Comment: Some commenters disagreed with our proposal and noted that adding DSMT to the list of approved telehealth services would provide a physician or practitioner with an additional tool for supporting patient compliance with management of diabetes. One commenter acknowledged that training patients in the self-administration of injectable drugs, a required component of DSMT programs, would be difficult to perform via telehealth. However, the commenter disagreed that this concern should prevent diabetes patients from accessing the

DSMT benefit through telehealth. The commenter believes that educating a patient on diet, exercise, medications, managing stress and illness, and managing blood sugar can be taught via telehealth.

Another commenter agreed that telehealth should not serve as a substitute for initial DSMT training that may involve hands-on teaching of injectable medications or appropriate usage of glucose monitors.

However, the commenter believes that follow-up telehealth encounters can help to quickly identify any potential problems or health concerns.

Response: The request we received was to add individual and group

DSMT as described by HCPCS codes G0108 and G0109 to the list of

Medicare

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telehealth services. As discussed above, teaching beneficiaries the skills necessary for the self administration of injectable drugs is a statutorily required element of DSMT (and is typically provided as part of an individual DSMT session). This skill based training is typically not a component of any of the current Medicare telehealth services.

Group DSMT (which comprises the vast majority of DSMT; initial and follow up) is by definition furnished in a group setting and, therefore, the interactive dynamic is not similar to any existing telehealth service. No group services are approved for telehealth. For more information on our review of the use of telehealth to furnish group services, see the CY 2006 PFS proposed rule (70 FR 45787).

In order to consider addition of services for Medicare telehealth that are not similar to the existing list of telehealth services, we require comparative studies showing that the use of an interactive audio and video telecommunications system is an adequate substitute for the in person (face-to-face) delivery of the requested service. To date, requestors have not submitted sufficient comparative analyses supporting the approval of skill based training (such as teaching a patient how to administer self-injectable drugs) for telehealth.

Likewise, requestors have not submitted comparative analyses showing that the use of a telecommunications system is an adequate substitute for group counseling services (DSMT or otherwise) furnished in person.

We agree with the commenters that skill-based training, such as teaching patients how to inject insulin, would be difficult to accomplish without the physical in person presence of the teaching practitioner. However, we disagree that this training element should be carved out of individual (or group) DSMT for purposes of providing

Medicare telehealth services. The skill-based training involved in teaching beneficiaries the skills necessary for the self-administration of injectable drugs is a key component of this statutorily defined benefit (and therefore inherent in the codes that describe DSMT). We do not believe that it would be appropriate to carve out this statutorily required component of DSMT for purposes of telehealth. b. Critical Care Services

The (UPMC) submitted a request to add critical care services (as defined by HCPCS codes 99291 and 99292) as a ``Category 1'' service.

The requester draws similarities to the evaluation and management (E/M) consultation services currently approved for telehealth. The requester noted that the primary difference between critical care and other E/M services already approved for telehealth is that critical care is specific to patients with vital organ failure. Anecdotally, UPMC has found that the use of telecommunications systems and software gives stroke patients timely access to highly specialized physicians.

According to the request, UPMC physicians are able to give ``an equally effective examination, spend the same amount of time with the patient and develop the same course of treatment just as if they were bedside.''

The acuity of a critical care patient is significantly greater than the acuity generally associated with patients receiving the E/M services approved for telehealth. Because of the acuity of critically ill patients, we do not consider critical care services similar to any services on the current list of Medicare telehealth services.

Therefore, we believe critical care must be evaluated as a Category 2 service.

Because we consider critical care services to be Category 2, we needed to evaluate whether these are services for which telehealth can be an adequate substitute for a face-to-face encounter. We had no evidence suggesting that the use of telehealth could be a reasonable surrogate for the face-to-face delivery of this type of care. As such, we did not propose to add critical care services (as defined by HCPCS codes 99291 and 99292) to the list of approved telehealth services.

Comment: UPMC submitted a detailed description of their experiences using telehealth to support the treatment of acute stroke patients and provided supporting studies describing the use of telemedicine in remote stroke assessment. Per their comment, remote stroke assessment has specific and unique clinical importance because an urgent decision, based in part on a neurological examination, must be made regarding the administration of thrombolytic therapy within 3 hours of the onset of stroke symptoms. The elements of remote stroke assessment involve discrete interactions between physicians and patients, and the consultative input of specialists experienced in acute stroke treatment is considered in directing the bedside care of the patient.

Some commenters were concerned that our proposal will not permit the use of telehealth to treat critically ill patients. We received comments and supporting documentation regarding the feasibility and value of providing consultations via telehealth to patients who are critically ill.

Response: Consultations are already included on the list of approved telehealth services. Our proposal not to add critical care services (as defined by 99291 and 99292) to the list of Medicare telehealth services does not preclude physicians or NPPs from providing medically necessary and clinically appropriate telehealth consultations to patients who are critically ill. We believe that permitting initial and follow up inpatient consultation via telehealth will help provide greater access to specialty care for critically ill patients (including stroke patients). If guidance or advice is needed regarding a critically ill patient, a consultation may be requested from an appropriate source and may be furnished as a telehealth service. (See the CMS Internet-Only Medicare Claims Processing Manual, Chapter 12,

Section 30.6.10 for more information on Medicare policy regarding payment for consultation services.)

In support of the request to approve critical care services (as described by HCPCS codes 99291 through 99292), UPMC provided comparative analyses involving the use of an interactive audio and video telecommunications system as a substitute for an in-person (face- to-face) clinical assessment. However, the focus of these studies was limited to stroke patients (critical care services include a broad range of disease categories). Additionally, one study recruited clinically stable patients. This study noted that ``because of the subacute nature of our test bed, the current data must be considered preliminary in determining their potential impact on actual clinical decision making.'' The same study also noted that although the use of telehealth ``may expedite stroke-related decision making, it cannot and should not be thought of as a substitute for the comprehensive clinical evaluation of the acute stroke patient, including thorough medical and cardiac evaluations.'' In another study submitted, the patients selected were not randomized.

Comment: A few commenters supported our proposal not to add critical care services to the list of Medicare approved telehealth services. The commenters believe that, within the current standards of practice, critical care services require the physical presence of the physician rendering the critical care services.

We received approximately 20 comments expressing opposition to our proposal not to add critical care services to the list of Medicare approved telehealth services which distinguished between their use of telehealth for

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critical care services and the use of telehealth for remote stroke assessments, as described in the original request. Many of the commenters characterized our proposal as a ``non-coverage determination'' of remote critical care services and described an intensive care unit (ICU) model that integrates continuous surveillance of the ICU with an electronic medical records interface. This model is also programmed to automatically prompt the physician to rapidly respond and intervene in the event of certain changes in a patient's physiological status. Many of these commenters included documentation and references to studies that the adoption of this model reduced medical errors; enhanced patient safety; reduced complications; decreased overall length of stay in the ICU; and resulted in a statistically significant decrease in ICU mortality in comparison to the traditional ICU model. The commenters also noted that patient outcomes have been equivalent if not superior to patient outcomes prior to adopting this model of care.

The American Medical Association (AMA) recently developed Category

III tracking codes for remote critical care services (0188T-0189T). Two specialty societies commented that they are working with other critical care organizations to collect and analyze data on remote critical care services, as requested by the CPT editorial panel.

Response: In the CY 2009 PFS proposed rule, we explained that we have no evidence suggesting that the use of telehealth could be a reasonable surrogate for the face-to-face delivery of critical care services, as defined by HCPCS codes 99291 and 99292. We agree with the comments that, within the current standards of practice, critical care services require the physical presence of the physician rendering the critical care services.

Our proposal not to add critical care services to the list of approved telehealth services for Medicare was in no way a ``non- coverage determination'' for remote critical care services described by the AMA's Category III tracking codes, 0188T-0189T. Consistent with the

AMA's creation of those tracking codes, we believe that remote critical care services are different from the telehealth delivery of critical care services (as defined by CPT codes 99291 through 99292). Category

III CPT codes track utilization of a service, facilitating data collection on, and assessment of new services and procedures. We believe that the data collected for these tracking codes will help provide useful information on how to best categorize and value remote critical care services in the future. However, at the present time, we do not have sufficient evidence that the provision of critical care services (as represented by HCPCS codes 99291 and 99292) via telehealth is an adequate substitute for an in person (face-to-face) encounter. c. Subsequent Hospital Care

Prior to 2006, follow-up inpatient consultations (as described by

CPT codes 99261 through 99263) were approved for telehealth. CPT 2006 deleted the follow-up inpatient consultation codes and advised practitioners instead to bill for these services using the codes for subsequent hospital care (as described by CPT codes 99231 through 99233). For CY 2006, we removed the deleted codes for follow-up inpatient consultations from the list of approved telehealth services.

In the CY 2008 PFS proposed rule (72 FR 38144) and subsequent final rule with comment period (72 FR 66250), we discussed a request we received from the ATA to add subsequent hospital care to the list of approved telehealth services. Because there is currently no method for practitioners to bill for follow-up inpatient consultations delivered via telehealth, the ATA requested that we approve use of the subsequent hospital care codes to bill follow-up inpatient consultations furnished via telehealth, as well as to bill for subsequent hospital care services furnished via telehealth that are related to the ongoing E/M of the hospital inpatient (72 FR 66250). Since the subsequent hospital care codes describe a broader range of services than follow-up inpatient consultation, including some services that may not be appropriate for addition to the list of telehealth services, we did not add subsequent hospital care to the list of approved telehealth services. Instead, we committed to continue to evaluate whether, and if so, by what mechanism subsequent hospital care could be approved for telehealth when used for follow-up inpatient consultations (72 FR 66249).

In the CY 2009 PFS proposed rule, we proposed to create a new series of HCPCS codes for follow-up inpatient telehealth consultations.

Practitioners would use these codes to submit claims to their Medicare contractors for payment of follow-up inpatient consultations provided via telehealth. We proposed that the new HCPCS codes would be limited to the range of services included in the scope of the previous CPT codes for follow-up inpatient consultations, and the descriptions would be modified to limit the use of such services for telehealth. The HCPCS codes would clearly designate these services as follow-up inpatient consultations provided via telehealth, and not subsequent hospital care used for inpatient visits. Utilization of these codes would allow for payment for these services, as well as enable us to monitor whether the codes are used appropriately. We also proposed to establish the RVUs for these services at the same level as the RVUs established for subsequent hospital care (as described by CPT codes 99231 through 99233). We believe this is appropriate because a physician or practitioner furnishing a telehealth service is paid an amount equal to the amount that would have been paid if the service had been furnished without the use of a telecommunication system. Since physicians and practitioners furnishing follow-up inpatient consultations in a face- to-face encounter must continue to utilize subsequent hospital care codes (as described by CPT codes 99231 through 99233), we believe it is appropriate to set the RVUs for the new telehealth G codes at the same level as for the subsequent hospital care codes.

Comment: Several commenters enthusiastically supported our proposal to create a new series of HCPCS codes for follow-up inpatient telehealth consultations. Some commenters were concerned that our proposed definition of the new HCPCS codes did not clearly distinguish these consultations from subsequent hospital care, and they believed it would not preclude the use of telehealth for the ongoing E/M of an inpatient. Other commenters supported our effort to reinstitute follow- up inpatient consultations delivered via telehealth, but discouraged us from creating new HCPCS codes for the long-term. A few commenters recommended that instead we approve subsequent hospital care for telehealth. The AMA and others urged us to implement the proposed G codes as an interim measure, while working expeditiously with the CPT

Editorial Panel and the RUC to develop appropriate codes and RVUs for the long-term.

Response: We are pleased that the majority of commenters supported our proposal to create a new series of HCPCS codes for follow-up inpatient telehealth consultations. As discussed in the CY 2009 PFS proposed rule, we considered other approaches to provide and bill for follow-up inpatient consultations delivered via telehealth. In response to the comments requesting that we approve subsequent hospital care for telehealth only when the codes are used for follow-up inpatient consultations, we were concerned that

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the other approaches under consideration would lead to a misuse of the service, and practitioners would provide a broader range of services via telehealth than was formerly approved, including the ongoing, day- to-day E/M of a hospital inpatient. We were also concerned that it could be difficult to implement sufficient controls and monitoring to ensure that whatever mechanism we created would be limited to the delivery of services that were formerly described as follow-up inpatient consultations. We continue to believe that creating HCPCS codes specific to the telehealth delivery of follow-up inpatient consultations allows us to provide payment for these services, as well as enables us to best monitor whether the codes are used appropriately.

As noted previously, CPT deleted the follow-up inpatient consultation codes. We determined that there was a need to establish a method by which practitioners could provide and bill Medicare for follow-up inpatient consultations delivered via telehealth, without allowing the ongoing E/M of a hospital inpatient via telehealth.

Physicians and NPPs furnishing follow-up inpatient consultations in a face-to-face encounter must continue to utilize subsequent hospital care codes (as described by CPT codes 99231 through 99233).

In response to commenters concerns that the new HCPCS codes will not prevent the use of telehealth for the ongoing E/M of an inpatient, we have modified the definition of follow-up inpatient telehealth consultations. We clarified that the criteria for these services will be subject to and consistent with Medicare policy for consultation services, including criteria that would distinguish a follow-up consultation from a subsequent E/M visit.

Result of Evaluation of 2009 Requests

We will finalize our proposal not to add DSMT (as defined by HCPCS codes G0108 and G0109) and not to add critical care services (as defined by HCPCS codes 99291 and 99292) to the list of Medicare telehealth services.

We will finalize our proposal to add follow-up inpatient telehealth consultation, as represented by HCPCS codes G0406 through G0408, to the list of Medicare telehealth services. We will also finalize our proposal to add follow-up inpatient telehealth consultations to the list of Medicare services at Sec. 410.78 and Sec. 414.65.

Practitioners would use the new HCPCS codes to submit claims to their Medicare contractors for payment of follow-up inpatient consultations provided via telehealth. These new HCPCS codes are limited to the range of services included in the scope of the previous

CPT codes for follow-up inpatient consultations, and the descriptions limit the use of such services for telehealth. The HCPCS codes clearly designate these services as follow-up inpatient consultations provided via telehealth, and not subsequent hospital care used for inpatient visits. Utilization of these codes will allow for payment for these services, as well as enable us to monitor whether the codes are used appropriately.

We also will finalize our proposal to establish the RVUs for these services at the same level as the RVUs established for subsequent hospital care (as described by CPT codes 99231 through 99233).

Physicians and NPPs furnishing follow-up inpatient consultations in a face-to-face encounter must continue to utilize subsequent hospital care codes (as described by CPT codes 99231 through 99233).

We are finalizing our proposal to create HCPCS codes specific to the telehealth delivery of follow-up inpatient consultations solely to re-establish the ability for practitioners to provide and bill for follow-up inpatient consultations delivered via telehealth. These codes are intended for use by practitioners serving beneficiaries located at qualifying originating sites (as defined in Sec. 410.78) requiring the consultative input of physicians who are not available for an in person

(face-to-face) encounter. These codes are not intended to include the ongoing E/M of a hospital inpatient.

Claims for follow-up inpatient telehealth consultations will be submitted to the Medicare contractors that process claims for the area where the physician or practitioner who furnishes the service is located. Physicians/practitioners must submit the appropriate HCPCS procedure code for follow-up inpatient telehealth consultations along with the ``GT'' modifier (``via interactive audio and video telecommunications system''). By coding and billing the ``GT'' modifier with the inpatient follow-up inpatient telehealth consultation codes, the distant site physician/practitioner certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished. (See the CMS Internet-Only Medicare Claims Processing

Manual, Pub. 100-04, Chapter 12, Sec. 190.6.1 for instructions for submission of interactive telehealth claims.)

In the case of Federal telemedicine demonstration programs conducted in Alaska or Hawaii, store-and-forward technologies may be used as a substitute for an interactive telecommunications system.

Covered store-and-forward telehealth services are billed with the

``GQ'' modifier, ``via asynchronous telecommunications system.'' By using the ``GQ'' modifier, the distant site physician/practitioner certifies that the asynchronous medical file was collected and transmitted to him or her at the distant site from a Federal telemedicine demonstration project conducted in Alaska or Hawaii. (See the CMS Internet-Only Medicare Claims Processing Manual, Pub. 100-04,

Chapter 12, Sec. 190.6.2 for instructions for submission of telehealth store and forward claims.)

Follow-Up Inpatient Telehealth Consultations Defined

Follow-up inpatient telehealth consultations are consultative visits furnished via telehealth to follow up on an initial consultation, or subsequent consultative visits requested by the attending physician. The initial inpatient consultation may have been provided in person or via telehealth. The conditions of payment for follow-up inpatient telehealth consultations, including qualifying originating sites and the types of telecommunications systems recognized by Medicare, are subject to the provisions of Sec. 410.78.

Payment for these services is subject to the provisions of Sec. 414.65.

Follow-up inpatient telehealth consultations include monitoring progress, recommending management modifications, or advising on a new plan of care in response to changes in the patient's status or no changes on the consulted health issue. Counseling and coordination of care with other providers or agencies is included as well, consistent with the nature of the problem(s) and the patient's needs. The physician or practitioner who furnishes the inpatient follow-up consultation via telehealth cannot be the physician of record or the attending physician, and the follow-up inpatient consultation would be distinct from the follow-up care provided by a physician of record or the attending physician. If a physician consultant has initiated treatment at an initial consultation and participates thereafter in the patient's ongoing care management, such care would not be included in the definition of a follow-up inpatient consultation and is not appropriate for delivery via telehealth. Follow-up inpatient telehealth consultations are subject to the criteria for consultation services, as

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described in the CMS Internet-Only Medicare Claims Processing Manual,

Pub 100-04, Chapter 12, Sec. 30.6.10.

Payment for follow-up inpatient telehealth consultations includes all consultation related services furnished before, during, and after communicating with the patient via telehealth. Pre-service activities would include, but would not be limited to, reviewing patient data (for example, diagnostic and imaging studies, interim lab work) and communicating with other professionals or family members. Intra-service activities must include at least two of the three key elements described below for each procedure code. Post-service activities would include, but would not be limited to, completing medical records or other documentation and communicating results of the consultation and further care plans to other health care professionals. No additional E/

M service could be billed for work related to a follow-up inpatient telehealth consultation.

Follow-up inpatient telehealth consultations could be provided at various levels of complexity. To reflect this, we are establishing three codes.

Practitioners taking a problem focused interval history, conducting a problem focused examination, and engaging in medical decision making that is straightforward or of low complexity, would bill a limited service, using HCPCS code G0406. At this level of service, practitioners would typically spend 15 minutes communicating with the patient via telehealth.

Practitioners taking an expanded focused interval history, conducting an expanded problem focused examination, and engaging in medical decision making that is of moderate complexity, would bill an intermediate service using HCPCS code G0407. At this level of service, practitioners would typically spend 25 minutes communicating with the patient via telehealth.

Practitioners taking a detailed interval history, conducting a detailed examination, and engaging in medical decision making that is of high complexity, would bill a complex service, using HCPCS code

G0408. At this level of service, practitioners would typically spend 35 minutes or more communicating with the patient via telehealth.

We are establishing the following HCPCS codes to describe follow-up inpatient consultations approved for telehealth:

G0406, Follow-up inpatient telehealth consultation, limited, typically 15 minutes communicating with the patient via telehealth.

G0407, Follow-up inpatient telehealth consultation, intermediate, typically 25 minutes communicating with the patient via telehealth.

G0408, Follow-up inpatient telehealth consultation, complex, typically 35 minutes or more communicating with the patient via telehealth. 3. Other Issues

Comment: In 2005, CMS received a request to add the following procedure codes to the list of approved telehealth services: initial nursing facility care (as described by HCPCS codes 99304 through 99306); subsequent nursing facility care (HCPCS codes 99307 through 99310); nursing facility discharge services (HCPCS codes 99315 and 99316); and other nursing facility services (as described by HCPCS code 99318). In the CY 2007 PFS final rule with comment period, we did not add these nursing facility care services to the list of approved telehealth services because these procedure codes did not describe services that were appropriate to the originating sites eligible in CY 2007. At that time, SNFs were not defined in the statute as originating sites. (See 71 FR 69657.)

Section 149 of the MIPPA recognizes SNFs as telehealth originating sites, effective for services furnished on or after January 1, 2009. In light of this provision, the American Telemedicine Association (ATA) urged us to add nursing facility care codes to the list of telehealth services for CY 2009, as requested in 2005.

Response: Section 149 of the MIPPA did not add any services to the approved telehealth list. Currently, telehealth may substitute for a face-to-face, ``hands on'' encounter for professional consultations, office visits, office psychiatry services, and a limited number of other PFS services that we have determined to be appropriate for telehealth. We will continue to review requests for additions to this list using our existing criteria.

Telehealth is a delivery mechanism for otherwise payable Part B services. Although the requested nursing facility services are not on the approved telehealth list, we will pay eligible distant site physicians or practitioners for eligible Medicare telehealth services if the service is separately payable under the PFS when furnished in a face-to-face encounter at a SNF effective January 1, 2009.

Since we believed it was not relevant to add these codes when SNFs were not eligible originating sites, we did not include a full review of these codes in the CY 2007 PFS proposed rule or final rule with comment period. We also note that in considering nursing facility care for telehealth, we would need to carefully evaluate the use of telehealth for the personal visits that are currently required under

Sec. 483.40, (which are billed using procedure codes included in this request). Overall, we believe that it would be more appropriate to consider the addition of nursing facility care services for telehealth through full notice and comment procedures.

In the CY 2010 PFS proposed rule, we will address the request to add nursing facility care services to the list of approved telehealth services, as received in 2005. In light of the previous request to add these services and the new legislation adding SNFs as permissible telehealth originating sites, we will accept additional information in support of this request for consideration in the CY 2010 proposed rule if received prior to December 31, 2008.

Comment: We received a request to add health and behavior assessment and intervention codes (as described by HCPCS codes 96150 through 96154) to the list of approved telehealth services.

Response: Requests submitted before the end of CY 2008 will be considered for the CY 2010 proposed rule. Requestors should be advised that each request to add a service to the list of Medicare telehealth services must include any supporting documentation the requestor wishes us to consider as we review the request. For more information on submitting a request for an addition to the list of Medicare telehealth services, including where to directly mail these requests, visit our

Web site at http://www.cms.hhs.gov/telehealth/.

E. Specific Coding Issues Related to the Physician Fee Schedule 1. Payment for Preadministration-Related Services for Intravenous

Infusion of Immune Globulin

In the CY 2009 PFS proposed rule (73 FR 38518), we proposed to discontinue payment for HCPCS code G0332, Services for intravenous infusion of immunoglobulin prior to administration (this service is to be billed in conjunction with administration of immunoglobulin), for services furnished after December 31, 2008.

Immune globulin is a complicated biological product that is purified from human plasma obtained from human plasma donors. In past years, there have been issues reported with the supply of intravenous immune globulin (IVIG) due to numerous factors including decreased manufacturing capacity, increased usage, more sophisticated

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processing steps, and low demand for byproducts from IVIG fractionation.

When IVIG is furnished to a patient in a physician's office, three different payments are usually recognized: payment for the IVIG product itself (described by a HCPCS J code); payment for the administration of the IVIG product (described by one or more CPT codes); and similar payment for the preadministration-related services (HCPCS code G0332).

The Medicare payment rates for IVIG products are established through the Part B average sales price (ASP) drug payment methodology.

As explained in detail in the CY 2006, CY 2007 and CY 2008 PFS final rules with comment period (70 FR 70218 to 70221, 71 FR 69678 to 69679, and 72 FR 66254 to 66255, respectively), we created, in 2006, a temporary code in order to pay separately for the IVIG preadministration-related services in order to assist in ensuring appropriate access to IVIG during a period of market instability. Part of this instability was due to the implementation of the new ASP payment methodology for IVIG drugs which began in 2005. The payment for preadministration-related services was continued in 2007 and 2008 because of continued reported instability in the IVIG marketplace. The preadministration-related payment was designed to pay the physician practice for the added costs of obtaining adequate supplies of the appropriate IVIG product and scheduling the patient infusion during a period of market uncertainty.

The PFS rates for the pre-administration service codes were $72,

$75, and $75 respectively in 2006, 2007, and 2008.

In the CY 2009 PFS proposed rule, we noted that the Office of the

Inspector General's (OIG) study on the availability and pricing of IVIG published in a April 2007 report entitled, ``Intravenous Immune

Globulin: Medicare Payment and Availability (OEI-03-05-00404),'' found that for the third quarter of CY 2006, just over half of IVIG sales to hospitals and physicians were at prices below Medicare payment amounts.

Relative to the previous three quarters, this represented a substantial increase of the percentage of sales with prices below Medicare amounts.

During the third quarter of 2006, 56 percent of IVIG sales to hospitals and over 59 percent of IVIG sales to physicians by the largest 3 distributors occurred at prices below the Medicare payment amounts. We reviewed national claims data for IVIG drug utilization as well as utilization of the preadministration-related services HCPCS code. The data show modest increases in the utilization of IVIG drugs and the preadministration-related services code, which suggest that IVIG pricing and access may be improving.

In the CY 2009 PFS proposed rule, we noted that these factors, taken as a whole, suggested a lessening of the instability of the IVIG market. As a result of these developments, we proposed to discontinue the preadministration-related service payment in 2009 for HCPCS code

G0332. For CY 2009, under the Outpatient Prospective Payment System

(OPPS), a proposal was made to package payment for HCPCS code G0332 (73

FR 41457).

The following is a summary of the comments received and our responses.

Comment: We received several comments from beneficiaries, patient advocate groups, manufacturers, and physicians. Most commenters opposed the elimination of the preadministration-related services payment. A few commenters requested that the preadministration-related services payment become permanent for both the PFS and the OPPS. Some commenters stated that the market conditions for IVIG are not fundamentally different than they were when CMS initially instituted the preadministration-related services payment in CY 2006. The commenters requested that CMS continue the separate payment until there is more stability in the IVIG market. Several commenters stated that the information CMS presented in the CY 2009 PFS proposed rule did not conclusively prove that the IVIG market was stabilizing. The commenters stated that significant access problems remain.

In response to the findings of the OIG report, some commenters stated that the lag inherent in the ASP pricing system may have played a role in substantially increasing the percentage of IVIG sales at prices below the Medicare payment amounts in the third quarter of 2006.

The preadministration-related service fee was cited as providing some assistance to physicians and hospitals that are experiencing problems obtaining IVIG. Several commenters noted that the OIG report could be interpreted as leaving a large percent of hospitals and physicians unable to acquire IVIG at prices below Medicare's payment amounts. Many commenters stated that they do not believe the introduction of new brand-specific reporting codes for IVIG will result in a more stable marketplace.

One commenter presented patient surveys conducted in CYs 2006, 2007 and 2008 which described access limitations and shifts in the site of service. These surveys were limited in size and surveyed only patients receiving IVIG for primary immune deficiency. Another commenter referred to a report on IVIG issued in February 2007 titled, ``Analysis of Supply, Distribution, Demand and Access Issues Associated with

Immune Globulin Intravenous'' prepared by the Eastern Research Group under contract (Contract No. HHSP23320045012XI) to the Assistant

Secretary of Planning and Evaluation in the U.S. Department of Health and Human Services and cited this report as an important source of information on IVIG usage and patient access.

Response: The separate payment for IVIG preadministration-related service was designed to compensate the physician practice for the additional, unusual, and temporary costs associated with obtaining IVIG products and scheduling patient infusions during a temporary period of market instability. This payment was never intended to subsidize payment for drugs made under the ASP system.

In the CY 2009 PFS proposed rule, we referred to data from the OIG study that indicated that for the third quarter of 2006, just over half of IVIG sales to hospitals and physicians were at prices below Medicare payment amounts. Relative to the previous three quarters, this represented a substantial increase of the percentage of sales with prices below Medicare amounts. We agree with the commenters that it is likely that increased ASP payments were the result of previous price increases from past quarters influencing future ASP data. Furthermore, the new HCPCS codes for IVIG products allow the physician to report and receive payment for the specific product furnished to the patient. We stated clearly in the CY 2006 PFS final rule with comment period that the preadministration-related services payment policy was a temporary measure to pay physicians for the unusual and temporary costs associated with procuring IVIG. We expected that these costs would decline over time as practices became more familiar with the nuances of the IVIG market and the availability of the limited primary and secondary suppliers in their areas.

We did not reference the report conducted by the Eastern Research

Group (Contract No. HHSP23320045012XI) in the proposed rule. As the commenter noted, this report provides important comprehensive background on the IVIG marketplace. For example, it provides an analysis of IVIG supply and distribution, and an analysis of the

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demand for and utilization of IVIG products. This report describes how

IVIG is administered and paid and includes information from the industry and others on physician and patient problems with access to

IVIG. The study is a collection of multi-source information that provides an understanding of the IVIG marketplace. One limitation of the study is it depicts the market only up through the first quarter of 2006 and it does not have detailed information on IVIG pricing as the

OIG report did. The OIG report also contains data from a later time period because it includes data through the third quarter of 2006.

We note, based on the information that follows, that the IVIG market today appears more stable than it was in CY 2006. We have reviewed national claims data for IVIG drug utilization, as well as the utilization of the preadministration-related services HCPCS code. These data show a modest increase in the utilization of IVIG and the preadministration-related services code in both physicians' offices and hospital outpatient departments from CY 2006 to CY 2007, after a period of decreased IVIG utilization in physicians' offices with a shift of

IVIG infusions to the hospital outpatient department in the previous year, which suggests that IVIG pricing and access may be improving.

National Medicare claims history data show that there were about 3.1 million units of IVIG administered in physicians' offices in CY 2006, and 7.3 million units in hospital outpatient departments. In CY 2007, those numbers rose to estimates of 3.3 million units and 8.1 million units in the office and hospital outpatient department settings, respectively. Under the OPPS, the total number of days of

IVIG administration increased modestly from CY 2006 to CY 2007, from 113,000 to 119,000. Aggregate allowed IVIG charges in the physician's office setting for CY 2006 were $82 million, while total payments

(including beneficiary copayments) under the OPPS were $184 million for the same time period. In CY 2007, aggregate allowed charges in the physician's office setting are estimated at $8 million, while total

OPPS payments are estimated at $246 million.

In summary, beginning in CY 2007, IVIG utilization increased modestly in both the physician's office setting and the hospital outpatient department, after a prior shift to the hospital and away from the physicians' offices, presumably reflecting increasing availability of IVIG and appropriate payment for the drug in both settings.

According to information on the Plasma Protein Therapeutics

Association (PPTA) Web site regarding the supply of IVIG, in the past year, while the supply has spiked at various times throughout the year, the supply has remained above or near the 12-month moving average.

While we acknowledge that the supply is only one of several factors that influence the market, we believe that an adequate supply is one significant factor that contributes to better access to IVIG for patients.

Therefore, because we believe that the reported transient market conditions that led us to adopt the separate payment for IVIG preadministration-related services have improved, we believe that continuation of the separate payment for preadministration services beyond CY 2008 is not warranted.

After consideration of the public comments received, we are finalizing our CY 2009 proposal, without modification, to discontinue separate payment under the PFS for IVIG preadministration-related services described by HCPCS code G0332. The treatment of payment for preadministration-related services under the OPPS will be addressed separately in that final rule. We will continue to work with IVIG stakeholders to understand their concerns regarding the pricing of IVIG and Medicare beneficiary access to this important therapy. 2. Multiple Procedure Payment Reduction for Diagnostic Imaging

In general, we price diagnostic imaging procedures in the following three ways:

The PC represents the physician's interpretation (PC-only services are billed with the 26 modifier).

The TC represents PE and includes clinical staff, supplies, and equipment (TC-only services are billed with the TC modifier).

The global service represents both PC and TC.

Effective January 1, 2006, we implemented a multiple procedure payment reduction (MPPR) on certain diagnostic imaging procedures (71

FR 48982 through 49252 and 71 FR 69624 through 70251). When two or more procedures within one of 11 imaging code families are furnished on the same patient in a single session, the TC of the highest priced procedure is paid at 100 percent and the TC of each subsequent procedure is paid at 75 percent (a 25-percent reduction). The reduction does not apply to the PC.

It is necessary to periodically update the list of codes subject to the MPPR to reflect new and deleted codes. In the CY 2009 PFS proposed rule, we proposed to subject several additional procedures to the MPPR

(73 FR 38519). Six procedures represent codes newly created since the

MPPR list was established. Four additional procedures have been identified as similar to procedures currently subject to the MPPR. We also proposed to remove CPT code 76778, a deleted code, from the list.

Table 6 contains the proposed additions to the list. After we adopted the MPPR, section 5102 of the Deficit Reduction Act of 2005 (Pub. L. 109-171) (DRA) exempted the expenditure reductions resulting from this policy from the statutory BN requirement. Therefore, we proposed that expenditure reductions resulting from these changes be exempt from BN.

(See the Regulatory Impact Analysis in section XVI. of this final rule with comment period for a discussion of BN.) The complete list of procedures subject to the MPPR is in Addendum F of this final rule with comment period.

Table 6--Procedures Proposed for Multiple Procedure Payment Reduction

CPT code

Short descriptor

Code family

70336......................... mri,

Family 5 MRI and MRA temporomandibula (Head/Brain/Neck). r joint(s). 70554......................... Fmri brain by

Family 5 MRI and MRA tech.

(Head/Brain/Neck). 75557......................... Cardiac mri for

Family 4 MRI and MRA morph.

(Chest/Abd/Pelvis). 75559......................... Cardiac mri w/

Family 4 MRI and MRA stress img.

(Chest/Abd/Pelvis). 75561......................... Cardiac mri for

Family 4 MRI and MRA morph w/dye.

(Chest/Abd/Pelvis). 75563......................... Cardiac mri w/

Family 4 MRI and MRA stress img & dye. (Chest/Abd/Pelvis). 76776......................... Us exam k transpl Family 1 Ultrasound w/doppler.

(Chest/Abdomen/

Pelvis--Non-

Obstetrical). 76870......................... Us exam, scrotum. Family 1 Ultrasound

(Chest/Abdomen/

Pelvis--Non-

Obstetrical). 77058......................... Mri, one breast.. Family 4 MRI and MRA

(Chest/Abd/Pelvis).

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77059......................... Mri, broth

Family 4 MRI and MRA breasts.

(Chest/Abd/Pelvis).

The following is a summary of the comments we received and our responses.

Comment: Some commenters indicated that the MPPR should not be extended to additional procedures without providing data supporting the appropriateness of a 25-percent payment reduction for the additional procedures. A commenter expressed concern that the MPPR was being extended to include breast MRIs, but the commenter provided no other information.

Response: As stated in the CY 2006 PFS final rule with comment period (70 FR 70261), when multiple images are taken in a single session, most of the clinical labor activities and supplies are not duplicated for subsequent procedures. Specifically, the following activities are not duplicated for subsequent procedures:

Greeting the patient.

Positioning and escorting the patient.

Providing education and obtaining consent.

Retrieving prior exams.

Setting up the IV.

Preparing and cleaning the room.

In addition, we considered that supplies, with the exception of film, are not duplicated for subsequent procedures.

To determine the appropriate level of the payment reduction for multiple procedures, we examined multiple pairs of procedure codes from the families representing all modalities (that is, ultrasound, CT/CTA, and MRI/MRA studies) that were frequently performed on a single day based on historical claims data. Using PE input data provided by the

RUC, we factored out the clinical staff minutes for the activities we indicated are not duplicated for subsequent procedures, and the supplies, other than film, which we considered are not duplicated for subsequent procedures. We did not assume any reduction in procedure

(scanning) time or equipment for subsequent procedures. However, equipment time and indirect costs are allocated based on clinical labor time; therefore, these inputs were reduced accordingly. Removing the PE inputs for activities that are not duplicated, and adjusting the equipment time and indirect costs for the individual pairs of procedures studied, supported payment reductions ranging from 40 to 59 percent for the subsequent services. Because we found a relatively narrow range of percentage payment reductions across modalities and families, and taking into consideration that we did not eliminate any duplicative image acquisition time for subsequent procedures in our analysis, we originally proposed an across-the-board MPPR for all 11 families of 50 percent (which is approximately the midpoint of the range established through our analysis). We believe this level of reduction was both justified and conservative (70 FR 45849). To allow for a transition of the changes in payments for these services attributable to this policy, we implemented a 25 percent payment reduction for all code families in CY 2006 which was scheduled to increase to a 50 percent reduction in CY 2007.

Subsequent to the publication of the CY 2006 PFS final rule with comment period, section 5102 (b) of the DRA capped the PFS payment for most imaging services at the amount paid under the hospital outpatient prospective payment system (OPPS). In addition, in response to our request for data on the appropriateness of the 50 percent reduction in the CY 2006 PFS final rule with comment period, the American College of

Radiology (ACR) provided information for 25 code combinations supporting a reduction of between 21 and 44 percent. Given the expected interaction between the MPPR policy and the further imaging payment reductions mandated by section 5102(b) of the DRA, along with the information we received from the ACR on the MPPR as it applies to common combinations of imaging services, we decided it was prudent to maintain the MPPR at its current 25 percent level while we continue to examine the appropriate payment levels. Therefore, we have maintained the MPPR at the 25 percent level.

In establishing the MPPR, we elected to use a single reduction percentage for all code pairs. We adopted a percentage reduction that is considerably lower than the range supported by our prior analysis, and slightly higher than the lowest percentage supported by ACR's analysis. We do not believe it is necessary to conduct another analysis for the additional codes because we adopted a conservative reduction percentage and are continuing use of a single reduction percentage for all code pairs. We believe the payment reduction policy, described above, represents an appropriate reduction for the typical delivery of multiple imaging services furnished in the same session.

Furthermore, in establishing the MPPR, we limited it to codes in the same family, that is, contiguous areas of the body that are commonly furnished on the same patient, in the same session, on the same day. We believe that the eight CPT codes that were newly created for 2007 or 2008, and proposed for inclusion in the MPPR beginning in

CY 2009 (CPT codes 70554, 75557, 75559, 75561, 75563, 76776, 77058, and 77059), would have been included on the MPPR list when it was finalized in CY 2006, had they existed at the time. These CPT codes are similar to CPT codes that were selected for the list in CY 2006 and can be classified into the 11 contiguous body area families already in existence. For example, the procedure described by CPT code 76776

(Ultrasound, transplanted kidney, real time and duplex Doppler with image documentation) is similar to the procedure described by CPT code 76705 (Ultrasound, abdominal, real time with image documentation; limited (for example, single organ, quadrant, follow-up), which has been subject to the MPPR since the creation of the policy in CY 2006.

Similarly, we believe we should add CPT codes 70336 and 76870, which were in existence in CY 2006, to the list because they also share characteristics with other procedures subject to the MPPR.

In response to the commenter expressing concern that we were adding the breast MRI CPT codes 77058 and 77059 in particular, we are not certain of the reason for his or her concern because none was stated.

However, we continue to believe it is appropriate to add these CPT codes because their addition is consistent with our policy for other procedures included in Family 4, which describe procedures involving

MRI of the chest area.

To the extent that the newly added procedures do not meet the MPPR criteria (for example, if they are not performed in the same session), they will be unaffected by the MPPR.

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Comment: Commenters noted that we proposed to establish new composite rates for certain multiple diagnostic imaging procedures performed at the same time in hospital outpatient settings. One commenter asked whether individual procedure payment rates, or the composite payment rates under hospital OPPS will be used for purposes of applying the OPPS cap to PFS services. The commenter also asked whether we will continue our policy of applying the MPPR before application of the OPPS cap.

Response: Under the PFS, services are paid based on the individual

CPT or HCPCS code. Therefore, the OPPS cap will continue to be applied based on the hospital OPPS ambulatory payment classification (APC) rate for the individual procedure, and not the composite rate. The policy of applying the MPPR before applying the OPPS cap remains unchanged.

Comment: Several commenters expressed concern that the proposed

MPPR undervalues the procedures and jeopardizes beneficiary access to care. One commenter indicated that we should examine any shifts in the site-of-service that may have resulted due to the MPPR.

Response: The Government Accountability Office (GAO) and the Office of the Inspector General (OIG) have been performing several reviews relating to the utilization of imaging procedures including the effects of the OPPS cap and the MPPR on utilization, payment, and access to care. We will continue to monitor the effects of the policies to ensure that beneficiaries have proper access to care.

After reviewing the public comments, we are proceeding with the policy as proposed. The ten additional procedures listed in Table 6 will be subject to the MPPR, effective January 1, 2009. 3. HCPCS Code for Prostate Saturation Biopsies

In the CY 2009 PFS proposed rule, we proposed to create four new G codes for prostate saturation biopsy as shown in Table 7, currently reported with CPT code 88305, Surgical pathology, gross and microscopic examination, which is separately billed by the physician for each core sample taken. We also proposed to have Medicare contractors price these codes.

Table 7--G Codes for Prostate Biopsy

G code

Descriptor

G0416.................................. Surgical pathology, gross and microscopic examination for prostate needle saturation biopsy sampling, 1-20 specimens.

G0417.................................. Surgical pathology, gross and microscopic examination for prostate needle saturation biopsy sampling, 21-40 specimens.

G0418.................................. Surgical pathology, gross and microscopic examination for prostate needle saturation biopsy sampling, 41-60 specimens.

G0419.................................. Surgical pathology, gross and microscopic examination for prostate needle saturation biopsy sampling, greater than 60 specimens.

The following is a summary of the comments we received and our responses.

Comment: Some commenters expressed opposition to this proposal, while others supported it but recommended modifications to the proposed

G codes. All commenters were opposed to Medicare contractor pricing the

G codes and stated that CMS, rather than the Medicare contractor, should assign an appropriate work value for each specimen level to capture the expertise, skill, time, and resources used to determine if prostate cancer is present.

Response: First, for CY 2009, the CPT Editorial Panel changed

Category III code (0137T) to a Category I code, 55706, Biopsies, prostate; needle, transperineal, stereotactic template guided saturation sampling including image guidance, which the AMA RUC valued at 6.15 work RVUs. As discussed in the proposed rule, we currently pay

$102.35 for CPT code 88305, which is the code used by pathologists when interpreting prostate biopsy samples. Patients requiring a prostate saturation biopsy generally have 30 to 60 specimens taken. The pathologist would bill CPT code 88305 for evaluation of each individual specimen. When CPT code 88305 is used to evaluate prostate saturation biopsies, the average total payment for the evaluation of samples from one prostate needle saturation biopsy ranges from $3000 to $6000, depending on the number of biopsies taken. We believe the use of CPT code 88305 to bill individually for the evaluation of each biopsy sample would result in overpayment for this service. Therefore, we are proceeding with the proposal to create four G codes for pathologic examination of prostate needle saturation tissue sampling for services furnished beginning in 2009.

However, we agree with commenters that, rather than having Medicare contractors price the new G codes, it would be preferable for us to specify the payment for these services. We generally use contractor pricing when we do not have sufficient information to set the price.

Upon further reflection, we believe we can set prices for the new G- codes by analogy to the current RVUs for two existing codes: 88304 and 88305. We selected the mid-point of the range of samples for G0417,

G0418, and G0419 to calculate the average number of samples for each code. We assumed 15 percent of the samples taken require considerable clinical expertise to differentiate and distinguish carcinoma from hyperplasia. We assigned the work and PE values of 88305 to the 15 percent of samples requiring this level of expertise. The remaining 85 percent of samples require confirmation of prostate tissue and interpretation indicating the presence of cancer or not since the diagnosis had been identified in the 15 percent of samples. We assigned the work and PE of 88304 to this group of samples. We assigned the full work and PE payment to the 15 percent sample component to reflect the skill, time, and effort required to identify and diagnose carcinoma. We applied the multiple surgical procedure discount (RVUs were reduced by 50 percent in accordance with current CMS policy) to the remaining 85 percent of samples reviewed for identification and confirmation of prostate tissue. We selected the 75th percentile of samples from G0416 to recognize the greater degree of skill, time, and effort required to review, identify, and interpret the initial biopsy specimens sampled.

(See Addendum B for the values assigned to these G codes.)

Note: Under the PFS, CPT code 88305 will continue to be recognized for those surgical pathology services unrelated to prostate needle saturation biopsy sampling.

F. Part B Drug Payment 1. Average Sales Price (ASP) Issues

Medicare Part B covers a limited number of prescription drugs and biologicals. For the purposes of this final rule with comment period, the term ``drugs'' will hereafter refer to both drugs and biologicals, unless otherwise specified. Medicare Part B covered drugs not paid on a cost or prospective payment basis generally fall into the following three categories:

Drugs furnished incident to a physician's service.

DME drugs.

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Drugs specifically covered by statute (certain immunosuppressive drugs, for example).

Beginning in CY 2005, the vast majority of Medicare Part B drugs not paid on a cost or prospective payment basis are paid under the ASP methodology. The ASP methodology is based on data submitted to us quarterly by manufacturers. In addition to the payment for the drug,

Medicare currently pays a furnishing fee for blood clotting factors, a dispensing fee for inhalation drugs, and a supplying fee to pharmacies for certain Part B drugs.

In this section, we discuss recent statutory changes to the ASP methodology and other drug payment issues. a. Determining the Payment Amount Based on ASP Data

The methodology for developing Medicare drug payment allowances based on the manufacturers' submitted ASP data is specified in 42 CFR part 414, subpart K. We initially established this regulatory text in the CY 2005 PFS final rule with comment period (69 FR 66424). We further described the formula we use to calculate the payment amount for each billing code in the CY 2006 PFS proposed rule (70 FR 45844) and final rule with comment period (70 FR 70217). With the enactment of the MMSEA, the formula we use changed beginning April 1, 2008. Section 112(a) of the MMSEA requires us to calculate payment amounts using a specified volume-weighting methodology. In addition, section 112(b) of the MMSEA sets forth a special rule for determining the payment amount for certain inhalation drugs.

For each billing code, we calculate a volume-weighted, ASP-based payment amount using the ASP data submitted by manufacturers.

Manufacturers submit ASP data to us at the 11-digit National Drug Code

(NDC) level, including the number of units of the 11-digit NDC sold and the ASP for those units. We determine the number of billing units in an

NDC based on the amount of drug in the package. For example: a manufacturer sells a box of four vials of a drug. Each vial contains 20 milligrams (mg). The billing code is per 10 MG. The number of billing units in this NDC for this billing code is (4 vials x 20mg)/10mg = 8 billable units.

Prior to April 1, 2008, we used the following three-step formula to calculate the payment amount for each billing code. First, we converted the manufacturer's ASP for each NDC into the ASP per billing unit by dividing the manufacturer's ASP for that NDC by the number of billing units in that NDC. Then, we summed the product of the ASP per billing unit and the number of units of the 11-digit NDC sold for each NDC assigned to the billing code. Then, we divided this total by the sum of the number of units of the 11-digit NDC sold for each NDC assigned to the billing code.

Beginning April 1, 2008, we use a two-step formula to calculate the payment amount for each billing code. We sum the product of the manufacturer's ASP and the number of units of the 11-digit NDC sold for each NDC assigned to the billing and payment code, and then divide this total by the sum of the product of the number of units of the 11-digit

NDC sold and the number of billing units in that NDC for each NDC assigned to the billing and payment code.

In addition to the formula change, the MMSEA established a special payment rule for certain inhalation drugs furnished through an item of durable medical equipment (DME). The ``grandfathering'' provision in section 1847A(c)(6)(C)(ii) of the Act requires that certain drugs be treated as multiple source drugs for purposes of calculating the payment allowance limits. Section 112(b) of the MMSEA requires that, effective April 1, 2008, the payment amount for inhalation drugs furnished through an item of DME is the lesser of the amount determined by applying the grandfathering provision or by not applying that provision. We reviewed our payment determinations effective January 1, 2008 to identify the drugs subject to this special rule, and implemented this new requirement in accordance with the statutory implementation date of April 1, 2008. We identified that albuterol and levalbuterol, in both the unit dose and concentrated forms, are subject to the special payment rule. At this time, we have not identified other inhalation drugs furnished through an item of DME to which section 112(b) of the MMSEA applies.

The provisions in section 112 of the MMSEA are self-implementing for services on and after April 1, 2008. Because of the limited time between enactment and the implementation date, it was not practical to undertake and complete rulemaking on this issue prior to implementing the required changes. As a result of the legislation, we proposed to revise Sec. 414.904 to codify the changes to the determination of payment amounts as required by section 112 of the MMSEA. We solicited comments on the proposed regulatory text.

The following is a summary of the comments we received and our responses.

Comment: We received a number of comments regarding our proposed regulatory text. All of comments we received strongly supported our proposed regulatory text. Several comments strongly urged CMS to ensure that the methodology is properly applied to all drugs paid under the

ASP methodology.

Response: We appreciate the support from the public with regard to the implementation of this statutory provision. We have been applying the revised methodology since April 2008 and are unaware of payment issues resulting from its usage. The new methodology is being applied consistently across all Part B drugs subject to the ASP methodology.

Comment: One commenter requested that we limit the application of the special payment rule, established by section 112(b) of MMSEA to only albuterol and levalbuterol.

Response: We disagree with this comment. While we currently believe that we have identified all of the drugs to which the special payment rule applies, it would be imprudent to expressly limit its application to albuterol and levalbuterol in the regulations text because the statute does not do so. The statute refers to certain drugs described in section 1842(o)(1)(G) of the Act. Thus, we believe the regulations text, as proposed, adequately specifies the drugs to which the special rule applies. We have committed, via postings on our web site, to proceeding transparently when making pricing determinations and have done so by posting our decisions on our web site. We will continue to do so in the future.

After review of the public comments, we are finalizing our proposed regulatory text at Sec. 414.904. b. Average Manufacturer Price (AMP)/ Widely Available Market Prices

(WAMP)

Section 1847A(d)(1) of the Act states that ``the Inspector General of HHS shall conduct studies, which may include surveys to determine the widely available market prices (WAMP) of drugs and biologicals to which this section applies, as the Inspector General, in consultation with the Secretary, determines to be appropriate.'' Section 1847A(d)(2) of the Act states that, ``Based upon such studies and other data for drugs and biologicals, the Inspector General shall compare the ASP under this section for drugs and biologicals with--

Page 69753

The WAMP for such drugs and biologicals (if any); and

The average manufacturer price (AMP) (as determined under section 1927(k)(1) of the Act for such drugs and biologicals.''

Section 1847A(d)(3)(A) of the Act states that, ``The Secretary may disregard the average sales price (ASP) for a drug or biological that exceeds the WAMP or the AMP for such drug or biological by the applicable threshold percentage (as defined in subparagraph (B)).'' The applicable threshold percentage is specified in section 1847A(d)(3)(B)(i) of the Act as 5 percent for CY 2005. For CY 2006 and subsequent years, section 1847A(d)(3)(B)(ii) of the Act establishes that the applicable threshold percentage is ``the percentage applied under this subparagraph subject to such adjustment as the Secretary may specify for the WAMP or the AMP, or both.'' In CY 2006 through CY 2008, we specified an applicable threshold percentage of 5 percent for both the WAMP and AMP comparisons. We based this decision on the limited data available to support a change in the current threshold percentage.

For CY 2009, we proposed to specify an applicable threshold percentage of 5 percent for the WAMP and the AMP comparisons. As we stated in the proposed rule, the OIG is continuing its ongoing comparison of both the WAMP and the AMP. However, information on how recent changes to the ASP weighting methodology may affect the comparison of WAMP/AMP to ASP was not available in time for consideration prior to developing our proposal to maintain the applicable threshold percentage at 5 percent for CY 2009. Although we have recently received reports comparing ASP to AMP in which the OIG states it has applied the new volume-weighting methodology consistently, we have not had sufficient time to analyze these reports.

Thus, we do not have data suggesting a more appropriate level for the threshold at this time. Therefore, we believe that continuing the 5 percent applicable threshold percentage for both the WAMP and AMP comparisons is appropriate for CY 2009.

As we noted in the CY 2008 PFS final rule with comment period (72

FR 66259), we understand that there are complicated operational issues associated with potential payment substitutions. We will continue to proceed cautiously in this area and provide stakeholders, particularly manufacturers of drugs impacted by potential price substitutions, with adequate notice of our intentions regarding such, including the opportunity to provide input with regard to the processes for substituting the WAMP or the AMP for the ASP. As part of our approach, we intend to develop a better understanding of the issues that may be related to certain drugs for which the WAMP and AMP may be lower than the ASP over time.

We solicited comments on our proposal to continue the applicable threshold at 5 percent for both the WAMP and AMP for CY 2009.

The following is a summary of the comments we received and our responses.

Comment: Most commenters supported maintaining the threshold at 5 percent. Other commenters suggested that we exercise caution in the determination of price substitutions and that we develop a formal process and criteria to determine when substitutions are necessary.

Commenters also recommended that we provide adequate notice prior to making a price substitution.

Response: We appreciate the comments to maintain the threshold at 5 percent. As we noted in the CY 2008 PFS final rule with comment period

(72 FR 66259), we understand that there are complicated operational issues associated with potential payment substitutions. We will continue to proceed cautiously in this area and provide stakeholders, particularly manufacturers of drugs impacted by potential price substitutions, with adequate notice of our intentions regarding such, including the opportunity to provide input with regard to the processes for substituting the WAMP or the AMP for the ASP. As part of our approach, we intend to develop a better understanding of the issues that may be related to certain drugs for which the WAMP and AMP may be lower than the ASP over time.

After reviewing of the public comments, we are finalizing our proposal to establish the WAMP/AMP threshold at 5 percent for CY 2009. 2. Competitive Acquisition Program (CAP) Issues

Section 303(d) of the MMA requires the implementation of a competitive acquisition program (CAP) for certain Medicare Part B drugs not paid on a cost or PPS basis. The provisions for acquiring and billing drugs under the CAP were described in the Competitive

Acquisition of Outpatient Drugs and Biologicals Under Part B proposed rule (March 4, 2005, 70 FR 10746) and the interim final rule (July 6, 2005, 70 FR 39022), and certain provisions were finalized in the CY 2006 PFS final rule with comment period (70 FR 70236). The CY 2007 PFS final rule with comment period (72 FR 66260) then finalized portions of the July 6, 2005 IFC that had not already been finalized.

The CAP is an alternative to the ASP (buy and bill) methodology of obtaining certain Part B drugs used incident to physicians' services.

Physicians who choose to participate in the CAP obtain drugs from vendors selected through a competitive bidding process and approved by

CMS. Under the CAP, physicians agree to obtain all of the approximately 190 drugs on the CAP drug list from an approved CAP vendor. A vendor retains title to the drug until it is administered, bills Medicare for the drug, and bills the beneficiary for cost sharing amounts once the drug has been administered. The physician bills Medicare only for administering the drug to the beneficiary. The CAP currently operates with a single CAP drug category. CAP claims processing began on July 1, 2006.

After the CAP was implemented, section 108 of the MIEA-TRHCA made changes to the CAP payment methodology. Section 108(a)(2) of the MIEA-

TRHCA requires the Secretary to establish (by program instruction or otherwise) a post-payment review process (which may include the use of statistical sampling) to assure that payment is made for a drug or biological only if the drug or biological has been administered to a beneficiary. The Secretary is required to recoup, offset, or collect any overpayments. This statutory change took effect on April 1, 2007.

Conforming changes were proposed in the CY 2008 PFS proposed rule (72

FR 38153) and finalized in the CY 2008 PFS final rule with comment period (72 FR 66260).

In the CY 2009 PFS proposed rule, we proposed several refinements to the CAP regarding the annual CAP payment amount update mechanism, the definition of a CAP physician, the restriction on physician transportation of CAP drugs, and the dispute resolution process (73 FR 38522). However, since the publication of our proposed rule, we have announced the postponement of the CAP for 2009 due to contractual issues with the successful bidders. As a result, CAP physician election for participation in the CAP in 2009 is not being held this Fall, and

CAP drugs will not be available from an Approved CAP Vendor for dates of service after December 31, 2008.

Moreover, we are currently soliciting public feedback on the CAP from participating physicians, potential vendors, and other interested parties. We are soliciting public comments

Page 69754

about a range of issues, including, but not limited to the following issues: the categories of drugs provided under the CAP; the distribution of areas that are served by the CAP; and procedural changes that may increase the program's flexibility and appeal to potential vendors and physicians. Interested parties can submit feedback about the CAP electronically or request to meet with us in person. Feedback about the CAP and meeting requests can be submitted electronically to: MMA303DDrugBid@cms.hhs.gov.

We will also host a CAP Open Door Forum (ODF) this December for participating physicians, potential vendors, and other interested parties. Participants will have an opportunity to discuss the postponement and suggest changes to the program. Additional information about this event will be available on the CMS CAP Web site at http:// www.cms.hhs.gov/CompetitiveAcquisforBios/.

We will assess information from the public and consider implementing changes to the CAP before proceeding with another bid solicitation for Approved CAP Vendor contracts. Furthermore, in light of the postponement of the CAP, we believe it would be prudent to consider the additional information that is being collected before finalizing any further changes to the program. For this reason, we will not finalize the CAP items in the CY 2009 proposed rule at this time.

We appreciate the comments that we have received and we will consider these comments as we assess potential changes to the program and future rulemaking.

G. Application of the HPSA Bonus Payment

Section 1833(m) of the Act provides for an additional 10-percent bonus payment for physicians' services furnished in a year to a covered individual in an area that is designated as a geographic Health

Professional Shortage Area (HPSA) as identified by the Secretary prior to the beginning of such year. The statute indicates that the HPSA bonus payment will be made for services furnished during a year in areas that have been designated as HPSAs prior to the beginning of that year. As a result, the HPSA bonus payment is made for physicians' services furnished in an area designated as of December 31 of the prior year, even if the area's HPSA designation is removed during the current year. However, for physicians' services furnished in areas that are designated as geographic HPSAs after the beginning of a year, the HPSA bonus payment is not made until the following year, if the area is still designated as of December 31 of that year.

In the CY 2005 PFS final rule with comment period (69 FR 66297), we stated that determination of zip codes for automatic HPSA bonus payment will be made on an annual basis and that there would be no updates to the zip code file during the year. We also stated that physicians furnishing covered services in ``newly designated'' HPSAs may add a modifier to their Medicare claims to collect the HPSA bonus payment until our next annual posting of zip codes for which automatic payment of the bonus will be made.

In the CY 2009 PFS proposed rule, we proposed to revise Sec. 414.67 to clarify that physicians who furnish services in areas that are designated as geographic HPSAs as of December 31 of the prior year but not included on the list of zip codes for automated HPSA bonus payments should use the AQ modifier to receive the HPSA bonus payment.

Comment: We received comments in support of using the AQ modifier to ensure that all physicians furnishing services in a geographic HPSA that is not included in the list of zip codes eligible for automatic bonus payments will still receive the 10-percent HPSA bonus payment.

One commenter emphasized that this clarification would lessen the administrative burdens they experienced from the lack of a modifier in the past.

A few commenters expressed concern that many physicians may not be aware of the AQ modifier requirement for services furnished in areas that are not on the list of zip codes for automatic payment. One commenter urged us to use educational materials and outreach in order to ensure physicians are aware they may need to use the AQ modifier when submitting their Medicare claims. Another commenter requested that we develop a method to ensure payments are received automatically for all physicians that would qualify for the HPSA bonus payment.

One commenter suggested that we change the HPSA bonus payment program to include nonphysicians and work with the Congress to allow all persons who directly bill under Part B to be eligible for the 10- percent bonus for working in a designated HPSA.

Response: We appreciate the comments in support of our efforts to ensure all physicians furnishing services to Medicare beneficiaries in an area that is designated as a geographic HPSA on December 31 of the prior year receive the HPSA bonus payment.

As a result of refinements in our systems, we expect that more areas that are eligible for the bonus payment will be on the list of zip codes eligible for automatic payment of the HPSA bonus, thereby reducing the number of physicians who need to use the modifier.

However, we acknowledge that some physicians may not be aware of the need to use the modifier if they are furnishing services in a geographic HPSA that was designated after the list of eligible zip codes was created but prior to December 31. We will continue to utilize our provider education resources to increase awareness of the appropriate application of the AQ modifier. We will also continue to refine our systems to include as many areas as possible to the list of zip codes that receive automatic HPSA bonus payments.

We recognize that there can be shortages of all types of healthcare practitioners and we indeed appreciate the value of these nonphysicians. However, section 1833(m) of the Act provides for the payment of an additional amount only to physicians and a change would require a statutory revision.

After careful consideration of all of the comments, we are adopting our proposal to add Sec. 414.67(d) with minor revisions to clarify that physicians who furnish services in areas that are designated as geographic HPSAs as of December 31 of the prior year but not included on the list of zip codes for automated HPSA bonus payments should use the AQ modifier to receive the HPSA bonus payment.

H. Provisions Related to Payment for Renal Dialysis Services Furnished by End-Stage Renal Disease (ESRD) Facilities

In the CY 2009 PFS proposed rule (73 FR 38527), we outlined for CY 2009 the proposed updates to the case-mix adjusted composite rate payment system established under section 1881(b)(12) of the Act, added by section 623 of the MMA. These included updates to the drug add-on component of the composite rate system, as well as the wage index values used to adjust the labor component of the composite rate.

Specifically, we proposed the following provisions which are described in more detail below in this section:

A zero growth update to the proposed 15.5 percent drug add-on adjustment to the composite rates for 2009 required by section 1881(b)(12)(F) of the Act (resulting in a $20.33 per treatment drug add-on amount).

An update to the wage index adjustment to reflect the latest available

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wage data, including a revised BN adjustment factor of 1.056672;

The completion of the 4-year transition from the previous wage-adjusted composite rates to the CBSA wage-adjusted rates, where payment will be based on 100 percent of the revised geographic adjustments; and

A reduction of the wage index floor from 0.7500 to 0.7000.

A total of 56 comments were submitted under the caption ``ESRD

PROVISIONS.'' Eight of these comments pertained to the proposed changes to ESRD payment related provisions listed above. The remaining 48 comments responded to the solicitation for public comment pertaining to the application of preventable hospital-acquired condition (HAC) payment provisions for IPPS hospitals in settings other than IPPS hospitals, including ESRD facilities. Please refer to section II.H.6. of this final rule with comment period for a discussion of the applicability of the HAC payment provision for IPPS hospitals in settings other than IPPS hospitals.

The ESRD payment related comments are discussed in detail below in this section. In addition, subsequent to the publication of the CY 2009

PFS proposed rule, section 153 of the Medicare Improvements for

Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275), enacted on July 15, 2008, mandates changes in ESRD payment effective January 1, 2009.

Section 153(a) of the MIPPA amends section 1881(b)(12)(G) of the

Act to increase the composite rate component of the payment system and amends section 1881(b)(12)(A) to revise payments to ESRD facilities.

The amendments that are effective January 1, 2009 include an update of 1 percent to the composite rate component of the payment system (for services furnished on or after January 1, 2009, and before January 1, 2010), and the establishment of a site neutral composite rate for both hospital-based and independent dialysis facilities which, when applying the geographic index, shall reflect the labor share based on the labor share otherwise applied for renal dialysis facilities. The labor share for both hospital-based and independent dialysis facilities is 53.711.

In addition, since we compute the drug add-on adjustment as a percentage of the weighted average base composite rate, the drug add-on percentage is decreased to account for the higher composite payment rate and will result in a 15.2 percent drug add-on adjustment for CY 2009. Since the statutory increase only applies to the composite rate, this adjustment to the drug add-on percentage is needed to ensure that the total drug add-on dollars remains constant.

Prior to the MIPPA provisions, effective for CY 2008, hospital- based dialysis facilities received a base composite rate of $136.68 and independent dialysis facilities received a base composite rate of

$132.49, and so the CY 2009 base composite rate for independent dialysis facilities prior to the MIPPA was $132.49. The MIPPA mandates that payments for both the hospital-based dialysis facilities and independent dialysis facilities be based on the independent dialysis facilities rate. The 1 percent increase to the independent dialysis facility's 2008 composite rate of $132.49 results in a 2009 base composite rate for both hospital-based and independent dialysis facilities of $133.81. A drug add-on amount of $20.33 per treatment remains the same for 2009, which results in a 15.2 percent increase over the base independent composite rate of $133.81. 1. Growth Update to the Drug Add-On Adjustment to the Composite Rates

Section 623(d) of the MMA added section 1881(b)(12)(B)(ii) of the

Act which requires us to establish an add-on to the composite rate to account for changes in the drug payment methodology stemming from enactment of the MMA. Section 1881(b)(12)(C) of the Act provides that the drug add-on must reflect the difference in aggregate payments between the revised drug payment methodology for separately billable

ESRD drugs and the AWP payment methodology. In 2005, we generally paid for ESRD drugs based on average acquisition costs. Thus, the difference from AWP pricing was calculated using acquisition costs. However, in 2006 when we moved to ASP pricing for ESRD drugs, we recalculated the difference from AWP pricing using ASP prices.

In addition, section 1881(b)(12)(F) of the Act requires that beginning in CY 2006, we establish an annual update to the drug add-on to reflect the estimated growth in expenditures for separately billable drugs and biologicals furnished by ESRD facilities. This growth update applies only to the drug add-on portion of the case-mix adjusted payment system.

The CY 2008 drug add-on adjustment to the composite rate is 15.5 percent. The drug add-on adjustment for 2008 incorporates an inflation adjustment of 0.5 percent. This computation is explained in detail in the CY 2008 PFS final rule with comment period (72 FR 66280 through 66282). a. Estimating Growth in Expenditures for Drugs and Biologicals for CY 2009

In the CY 2007 PFS final rule with comment period (71 FR 69682), we established an interim methodology for annually estimating the growth in ESRD drugs and biological expenditures that uses the Producer Price

Index (PPI) for pharmaceuticals as a proxy for pricing growth, in conjunction with 2 years of ESRD drug data, to estimate per patient utilization growth. We indicated that this methodology would be used to update the drug add-on to the composite rate until such time that we had sufficient ESRD drug expenditure data to project the growth in ESRD drug expenditures beginning in CY 2010.

For CY 2009, we proposed revising the interim methodology for estimating the growth in ESRD drug expenditures by using ASP pricing instead of the PPI to estimate the price component of the update calculation.

As detailed below in this section, we proposed for CY 2009 to estimate price growth using historical ASP pricing data for ESRD drugs for CY 2006 through CY 2008, and to estimate growth in per patient utilization of drugs by using ESRD facility historical drug expenditure data for CY 2006 and CY 2007. b. Estimating Growth in ESRD Drug Prices

For CY 2009, we proposed to estimate price growth using ASP pricing data for the four quarters of CY 2006 and CY2007, and the two available quarters of CY 2008. For this final rule with comment period, we are using four quarters of ASP prices for CYs 2006, 2007, and 2008. We calculated the weighted price change, for the original top ten ESRD drugs for which we had acquisition pricing, plus Aranesp. In CY 2006 and CY 2007, we calculated a weighted average price reduction of 1.8 percent. We also calculated a weighted average price reduction of 2.1 percent between CY 2007 and CY 2008. The overall average price reduction is 1.9 percent over the 3-year period. Thus, the weighted average ESRD drug pricing change projected for CY 2009 is a reduction of 1.9 percent.

Comment: Commenters were generally opposed to the use of ASP prices to estimate the price component of the drug add-on adjustment. One commenter stated that although the price of EPO has declined in the past few years, it has now stabilized and will likely not decline again in CY 2009. Two commenters, including MedPAC, supported the use of ASP prices stating that it is more closely related to the

Page 69756

actual ESRD drug pricing than the use of the overall drug PPI. Another commenter stated that the PPI was a more accepted proxy for predicting drug price increases compared to ASP price trends which have never been used in forecasting drug price changes. Some suggested that we use a blend of ASP and PPI to soften the impact of the change in the methodology.

Response: Given that the statutory language mandates that we estimate the growth in ESRD drug expenditures in order to update the drug add-on adjustment, we believe we have an obligation to utilize the best data available to make those estimates. Although the PPI is a well recognized measure of overall drug price growth, it is not specific to

ESRD drug prices. Given that ESRD drug pricing trends are very different from overall drug pricing trends, we do not believe it would be appropriate to continue using the PPI when more specific data are available. ASP pricing data that are specific to ESRD drugs provide the most accurate measure for estimating the price component of the total

ESRD drug expenditure estimate for CY 2009. Therefore, for this final rule with comment period, we used ASP pricing data to estimate price growth in ESRD drugs. c. Estimating Growth in per Patient Drug Utilization

To isolate and project the growth in per patient utilization of

ESRD drugs for CY 2009, we removed the enrollment and price growth components from the historical drug expenditure data, and considered the residual to be utilization growth. As discussed previously in this section, we proposed to use ESRD facility drug expenditure data from CY 2006 and CY 2007 to estimate per patient utilization growth for CY 2009.

We first estimated total drug expenditures for all ESRD facilities.

For the CY 2009 PFS proposed rule (73 FR 38528), we used the final CY 2006 ESRD claims data and the latest available CY 2007 ESRD facility claims, updated through December 31, 2007 (that is, claims with dates of service from January 1 through December 31, 2007, that were received, processed, paid, and passed to the National Claims History

File as of December 31, 2007). For this final rule with comment period, we are using additional updated CY 2007 claims with dates of service for the same time period. This updated CY 2007 data file will include claims received, processed, paid, and passed to the National Claims

History File as of June 30, 2008.

For the CY 2009 PFS proposed rule, we adjusted the December 2007 file to reflect our estimate of what total drug expenditures would be using the final June 30, 2008 bill file for CY 2007. The net adjustment we applied to the CY 2007 claims data was an increase of 12.6 percent to the December 2007 claims file. To calculate the proposed per patient utilization growth, we removed the enrollment component by using the growth in enrollment data between CY 2006 and CY 2007. This was approximately 3 percent. To remove the price effect, we calculated the weighted change between CY 2006 and CY 2007 ASP pricing for the top eleven ESRD drugs. We weighted the differences using 2007 ESRD facility drug expenditure data.

This process led to an overall 1.8 percent reduction in price between CY 2006 and CY 2007.

After removing the enrollment and price effects from the expenditure data, the residual growth would reflect the per patient utilization growth. To do this, we divided the product of the enrollment growth of 3 percent (1.03) and the price reduction of 1.8 percent (1.00 - 0.018 = 0.982) into the total drug expenditure change between 2006 and 2007 of 0 percent (1.00 - 0.00 = 1.00). The result is a utilization factor equal to 0.99 or 1.00/(1.03 * 0.982) = 0.99.

Since we observed a 1 percent drop in per patient utilization of drugs between CY 2006 and CY 2007, we projected a 1 percent drop in per patient utilization for ESRD facilities in CY 2009.

Comment: A few commenters suggested that the use of CY 2007 billing data to predict utilization change in CY 2009 is not accurate since the utilization change in CY 2007 was driven by a revision to the EPO monitoring policy which caused a one-time decline in utilization that has since leveled off.

Response: We agree that the revised monitoring policy for erythropoesis stimulating agents (ESAs) that took effect in CY 2007 could have contributed to the observed decrease in ESRD drug utilization between CY 2006 and CY 2007, especially given that EPO and

Aranesp make up over 75 percent of all ESRD drug expenditures.

Moreover, this effect could distort our estimate of per patient utilization growth in CY 2009. Since CY 2007, we have analyzed 2 years of historical claims data for estimating growth in utilization (CY 2005 and CY 2006). During that period, utilization based on an analysis of independent ESRD facility drug data has indicated no growth. We believe the use of CY 2005 and CY 2006 drug data is the best data available for use in projecting utilization in CY 2009. Therefore, for CY 2009, we will continue to use our estimate of growth in utilization based on CY 2005 and CY 2006 data (72 FR 66282). That is, we are finalizing an estimation of no growth in utilization for CY 2009. 2. Applying the Proposed Growth Update to the Drug Add-on Adjustment

In the CY 2007 PFS final rule with comment period (71 FR 69684), we revised our update methodology by applying the growth update to the per treatment drug add-on amount. That is, for CY 2007, we applied the growth update factor of 4.03 percent to the $18.88 per treatment drug add-on amount for an updated amount of $19.64 per treatment (71 FR 69684). For CY 2008, the per treatment drug add-on amount was updated to $20.33.

For CY 2009, we proposed no update to the per treatment drug add-on amount of $20.33 established in CY 2008. 3. Update to the Drug Add-On Adjustment

In the CY 2009 PFS proposed rule (73 FR 38529), we estimated a 1 percent reduction in per patient utilization of ESRD drugs for CY 2009.

Using the projected decline of the CY 2009 ASP pricing for ESRD drugs of 1.9 percent, we projected that the combined growth in per patient utilization and pricing for CY 2009 would result in a negative update equal to -2.9 percent (0.99 * 0.981 = 0.971). However, we proposed to apply a zero percent update to the drug add-on adjustment and maintain the $20.33 per treatment drug add-on amount for CY 2009 that reflects a 15.5 percent drug add-on adjustment to the composite rate for CY 2009.

In addition, for CY 2009 we presented an alternative approach to the zero percent update. The alternative approach would be to apply an adjustment of less than 1.0 to the drug add-on adjustment. For CY 2009, we would ``increase'' the drug add-on by 0.971. Applying the 0.971 increase to the $20.33 per treatment adjustment would yield a drug add- on amount of $19.74 per treatment, which represents a 0.4 percent decrease in the CY 2008 drug add-on percentage of 15.5 percent. As such, the drug add-on adjustment to the composite rate for CY 2009 would be equal to 1.155 * 0.996 = 1.15 or 15.0 percent.

We solicited public comment on our proposal of a zero update, as well as the alternative approach presented above, so that we could make an informed decision with respect to the final update

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to the CY 2009 drug add-on adjustment to the composite rate.

Comment: Commenters were uniformly opposed to any decrease in the drug add-on adjustment, citing the plain reading of the statute which calls for an annual ``increase'' in the adjustment. As support for the reliance on the plain reading of the statute, several commenters cited case law examples in which courts have relied on dictionary definitions, biblical text, and common usage of terms for purposes of interpreting statutory text. One commenter disagreed with CMS' alternative reading of 1881(b)(12)(F) of the Act, under which an increase in the drug add-on could not be implemented when estimated drug growth is negative, pointing to MMA Conference Report language that referenced a payment update that would be based on a ``growth'' in drug spending and ``drug cost increases.'' Commenters further argued, citing case law the priority on plain language over policy arguments and cautioned against identifying gaps in statutes.

One commenter suggested that we should use the methodology to estimate growth in ESRD drug expenditures that yields a positive adjustment as required by the statute. Another commenter stated that if we believe ESRD drug expenditures will decline, this would indicate that the spread between AWP and ASP pricing will widen in CY 2009, thus justifying an increase in the drug add-on adjustment.

Response: We agree that the plain reading of the statute would preclude any decrease in the drug add-on adjustment and would not support a negative growth update. Specifically, section 1881(b)(12)(F) of the Act states in part that ``the Secretary shall annually increase'' the drug add-on amount based on the growth in expenditures for separately billed ESRD drugs. We interpret the statutory language

``annually increase'' to mean a positive or zero update to the drug add-on given that the statute also requires that the annual

``increase'' to the drug add-on adjustment reflect our estimate of the growth in ESRD drug expenditures. Since our analysis indicates a projected reduction in ESRD drug expenditures for CY 2009, we do not believe it would be appropriate to provide an increase that cannot be substantiated by the best data available.

Therefore, we are finalizing our proposal to provide a zero update to the drug add-on adjustment for CY 2009. If the statute had included, instead of the word ``increase,'' a broader term, we believe we would have had authority to decrease the rate to take into account the projected reduction. 4. Final Growth Update to the Drug Add-On Adjustment for 2009

As we indicated earlier, we have decided not to use CY 2007 expenditure data to estimate utilization growth for CY 2009, because of the potential distortion of our estimates due to the implementation of the ESA monitoring policy in 2007. Therefore, for this final rule with comment period, we are using the same data we use to estimate growth in utilization for CY 2008 as outlined in the CY 2008 PFS final rule with comment period (72 FR 66282). That is, for CY 2009, we estimate no growth in per patient utilization of ESRD drugs for CY 2009.

Similar to the CY 2009 PFS proposed rule, we estimated growth in

ESRD drug prices using ASP pricing data for CYs 2006, 2007 and 2008. In the proposed rule, we had only 2 quarters of data for 2008, but for this final rule all four quarters of ASP pricing data are available. We calculated the weighted price change for the top eleven ESRD drugs.

Tables 8 and 9 show the average ASP prices and the 2007 weights used.

We note that the final CY 2007 weights are derived from the final CY 2007 ESRD facility claims file as of June 30, 2008. For CY 2006 and CY 2007, we calculated a weighted average price reduction of 1.8 percent.

We also calculated a weighted average price reduction of 1.9 percent between CY 2007 and CY 2008. The overall average price reduction is 1.8 percent over the 3-year period. Thus, the weighted average ESRD drug pricing change projected for CY 2009 is a reduction of 1.8 percent.

We project that the combined growth in per patient utilization and pricing of ESRD drugs for CY 2009 would result in a negative update equal to -1.8 percent (1.00 * 0.982 = 0.982). If we implement this decrease in the update to the drug-on adjustment, the resulting savings would have been $14 million. However, as indicated above, for this final rule with comment period, we are applying no update to the drug add-on adjustment for CY 2009. Thus, we are applying a zero update to the $20.33 per treatment drug add-on amount for CY 2009. After adjusting for the MIPPA changes as discussed earlier in this section, the final drug add-on adjustment to the composite rate for CY 2009 is 15.2 percent.

Table 8--CY 2006, 2007 and 2008 ESRD Drug ASP Prices

Independent drugs

CY 2006

CY 2007

CY 2008

EPO.............................................................

$9.46

$9.17

$9.05

Paricalcitol....................................................

3.81

3.79

3.78

Sodium-ferric-glut..............................................

4.88

4.76

4.81

Iron-sucrose....................................................

0.36

0.37

0.36

Levocarnitine...................................................

9.44

8.07

6.31

Doxercalciferol.................................................

2.97

2.68

2.75

Calcitriol......................................................

0.55

0.54

0.40

Iron-dextran....................................................

11.94

11.69

Vancomycin......................................................

3.23

3.43

3.19

Alteplase.......................................................

31.63

33.21

33.06

Aranesp.........................................................

3.01

3.29

2.86

Table 9--CY 2007 Drug Weights for ESRD Facilities

CY 2007

Independent drugs

weights (%)

EPO.....................................................

69.1

Paricalcitol............................................

11.9

Sodium-ferric-glut......................................

2.5

Iron-sucrose............................................

6.1

Levocarnitine...........................................

0.2

Doxercalciferol.........................................

2.8

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Calcitriol..............................................

0.1

Iron-dextran............................................

0.0

Vancomycin..............................................

0.1

Alteplase...............................................

1.0

Aranesp.................................................

6.2

5. Update to the Geographic Adjustments to the Composite Rates

Section 1881(b)(12)(D) of the Act, as added by section 623(d) of the MMA, gives the Secretary the authority to revise the wage indexes previously applied to the ESRD composite rates. The wage indexes are calculated for each urban and rural area. The purpose of the wage index is to adjust the composite rates for differing wage levels covering the areas in which ESRD facilities are located. a. Updates to Core-Based Statistical Area (CBSA) Definitions

In the CY 2006 PFS final rule with comment period (70 FR 70167), we announced our adoption of the OMB's CBSA-based geographic area designations to develop revised urban/rural definitions and corresponding wage index values for purposes of calculating ESRD composite rates. OMB's CBSA-based geographic area designations are described in OMB Bulletin 03-04, originally issued June 6, 2003, and is available online at http://www.whitehouse.gov/omb/bulletins/b03- 04.html. In addition, OMB has published subsequent bulletins regarding

CBSA changes, including changes in CBSA numbers and titles. We wish to point out that this and all subsequent ESRD rules and notices are considered to incorporate the CBSA changes published in the most recent

OMB bulletin that applies to the hospital wage index used to determine the current ESRD wage index. The OMB bulletins may be accessed online at http://www.whitehouse.gov/omb/bulletins/index.html. b. Updated Wage Index Values

In the CY 2007 PFS final rule with comment period (71 FR 69685), we stated that we intended to update the ESRD wage index values annually.

The current ESRD wage index values for CY 2008 were developed from FY 2004 wage and employment data obtained from the Medicare hospital cost reports. The ESRD wage index values are calculated without regard to geographic classifications authorized under sections 1886(d)(8) and

(d)(10) of the Act and utilize pre-floor hospital data that is unadjusted for occupational mix. To calculate the ESRD wage index, hospital wage index data for FY 2004 for all providers in each urban/ rural geographic area are combined. The sum of the wages for all providers in each geographic area was divided by the total hours for all providers in each area. The result is the average hourly hospital wage for that geographic locale. The ESRD wage index was computed by dividing the average hourly hospital wage for each geographic area by the national average hourly hospital wage. The final step was to multiply each wage index value by the ESRD wage index budget neutrality factor (BNF).

We proposed to use the same methodology for CY 2009, with the exception that FY 2005 hospital data will be used to develop the CY 2009 wage index values. The CY 2009 ESRD wage index BNF is 1.056689.

This figure differs slightly from the figure in the proposed rule

(1.056672) because we used updated hospital wage data and treatment counts from the most current claims data. (See section II.H.5.c. of this final rule with comment period for details about this adjustment.)

For a detailed description of the development of the CY 2009 wage index values based on FY 2005 hospital data, see the FY 2009 ``Hospital

Inpatient Prospective Payment Systems (IPPS) and Final Fiscal Year 2009

Rates'' rule (73 FR 23630). Section III.G. of the preamble to the FY 2009 IPPS final rule, Computation of the Final FY 2009 Unadjusted Wage

Index, describes the cost report schedules, line items, data elements, adjustments, and wage index computations. The wage index data affecting

ESRD composite rates for each urban and rural locale may also be accessed on the CMS Web site at http://www.cms.hhs.gov/

AcuteInpatientPPS/WIFN/list.asp. The wage data are located in the section entitled, ``FY 2009 Final Rule Occupational Mix Adjusted and

Unadjusted Average Hourly Wage and Pre-reclassified Wage Index by

CBSA.'' i. Fourth Year of the Transition

In the CY 2006 PFS final rule with comment period (70 FR 70167 through 70169), we indicated that we would apply a 4-year transition period to mitigate the impact on the composite rates resulting from our adoption of CBSA-based geographic designations. Beginning January 1, 2006, during each year of the transition, an ESRD facility's wage- adjusted composite rate (that is, without regard to any case-mix adjustments) is a blend of its old MSA-based wage-adjusted payment rate and its new CBSA-based wage adjusted payment rate for the transition year involved. In CY 2006, the first year of the transition, we implemented a 75/25 blend. In CY 2007, the second year of the transition, we implemented a 50/50 blend. In CY 2008, the third year of the transition, we implemented a 25/75 blend. Consistent with the transition blends announced in the CY 2006 PFS final rule with comment period (70 FR 70170), in CY 2009, each ESRD facility's composite payment rate will be based entirely on the CBSA-based wage index.

For CY 2009, we proposed to reduce the wage index floor from 0.75 to 0.70. For this final year of the transition (CY 2009), we believe that a reduction to 0.70 is appropriate as we continue to reassess the need for a wage index floor in future years. We believe that a gradual reduction in the floor is still needed to ensure patient access to dialysis in areas that have low wage index values, especially Puerto

Rico, and to prevent sudden adverse effects to the payment system.

However, we note that our goal is the eventual elimination of all wage index floors.

The wage index floor and blended share applicable for CY 2009 are shown in Table 10.

Table 10--Wage Index Transition Blend

CY payment

Floor

Ceiling

Old MSA

New CBSA

2009.........................

0.70* None.......................

100%

* Each wage index floor is multiplied by a BN adjustment factor. For CY 2009 the BN adjustment is 1.056689 resulting in an actual wage index floor of 0.7397.

Page 69759

Because CY 2009 is the final year of the 4-year transition period, each

ESRD facility's composite payment rate will be based entirely on its applicable new CBSA-based wage index value.

Comment: We received a few comments that commend CMS for its use of a transition policy in shifting the Medicare ESRD program into a new geographic wage index system. Commenters stressed that prior to the elimination to the floor, we should provide protection to facilities in areas that would otherwise not be able to support dialysis facilities, which will ensure that access to care for beneficiaries is not compromised.

Response: We note that our goal is the eventual elimination of all wage index floors. However, we believe that a gradual reduction in the floor is still needed to ensure patient access to dialysis in areas that have low wage index values, especially Puerto Rico, and to prevent sudden adverse effects to the payment system. We will continue to reassess the need for a wage index floor in future years. ii. Wage Index Values for Areas With No Hospital Data

In CY 2006, while adopting the CBSA designations, we identified a small number of ESRD facilities in both urban and rural geographic areas where there are no hospital wage data from which to calculate

ESRD wage index values. The affected areas were rural Massachusetts, rural Puerto Rico, and the urban area of Hinesville, GA (CBSA 25980).

For CY 2006, CY 2007, and CY 2008, we calculated the ESRD wage index values for those areas as follows:

For rural Massachusetts, because we had not determined a reasonable wage proxy, we used the FY 2005 wage index value in CY 2006 and CY 2007. For CY 2008, we used an alternative methodology as explained below.

For rural Puerto Rico, the situation was similar to rural

Massachusetts. However, because all geographic areas in Puerto Rico were subject to the wage index floor in CY 2006, CY 2007, and CY 2008, we applied the ESRD wage index floor to rural Puerto Rico as well.

For the urban area of Hinesville, GA, we calculated the CY 2006, CY 2007, and CY 2008 wage index value based on the average wage index value for all urban areas within the State of Georgia.

For CY 2008, we adopted an alternative methodology for establishing a wage index value for rural Massachusetts. Because we used the same wage index value for 2 years with no update, we believed it was appropriate to establish a methodology which employed reasonable proxy data for rural areas (including rural Massachusetts), and also permitted annual updates to the wage index based on that proxy data.

For rural areas without hospital wage data, we used the average wage index values from all contiguous CBSAs as a reasonable proxy for that rural area.

In determining the imputed rural wage index, we interpreted the term ``contiguous'' to mean sharing a border. In the case of

Massachusetts, the entire rural area consists of Dukes and Nantucket

Counties. We determined that the borders of Dukes and Nantucket counties are contiguous with Barnstable and Bristol counties. We will continue to use the same methodology for CY 2009. Under this methodology, the CY 2009 wage index values for the counties of

Barnstable (CBSA 12700, Barnstable Town, MA-1.2643) and Bristol (CBSA 39300, Providence-New Bedford-Fall River, RI-MA-1.0696) were averaged resulting in an imputed proposed wage index value of 1.1670 for rural

Massachusetts in CY 2009.

For rural Puerto Rico, we continued to apply the wage index floor in CY 2008. Because all areas in Puerto Rico that have a wage index were eligible for the ESRD wage index floor of 0.75, we applied that floor to ESRD facilities located in rural Puerto Rico. For CY 2009, all areas in Puerto Rico that have a wage index are eligible for the final

ESRD wage index floor of 0.70. Therefore, we will apply the ESRD wage index floor of 0.70 to all ESRD facilities that are located in rural

Puerto Rico.

For Hinesville, GA (CBSA 25980), which is an urban area without specific hospital wage data, we proposed to apply the same methodology in 2009 that we used to impute a wage index value in CY 2006, CY 2007, and CY 2008. Specifically, we proposed to use the average wage index value for all urban areas within the State of Georgia. We are finalizing our proposal, which results in a CY 2009 wage index value of 0.9110 for the Hinesville-Fort Stewart GA CBSA.

In the CY 2008 PFS final rule with comment period (72 FR 66283 through 66284), we stated that we would continue to evaluate existing hospital wage data and possibly wage data from other sources such as the Bureau of Labor Statistics, to determine if other methodologies might be appropriate for imputing wage index values for areas without hospital wage data for CY 2009 and subsequent years. To date, no data from other sources, superior to that currently used in connection with the IPPS wage index, have emerged. Therefore, for ESRD purposes, we continue to believe this is an appropriate policy. We received no comments on this section and are finalizing our policies for wage areas with no hospital data as proposed. iii. Evaluation of Wage Index Policies Adopted in the FY 2008 IPPS

Final Rule

We stated in the CY 2008 PFS final rule with comment period (72 FR 66284) that we planned to evaluate any policies adopted in the FY 2008

IPPS final rule (72 FR 47130, 47337 through 47338) that affect the wage index, including how we treat certain New England hospitals under section 601(g) of the Social Security Amendments of 1983 (Pub. L. 98- 21). This is relevant for the ESRD composite payment system, because the ESRD wage index is calculated using the same urban/rural classification system and computation methodology applicable under the

IPPS, except that it is not adjusted for occupational mix and does not reflect geographic classifications authorized under sections 1886(d)(8) and (d)(12) of the Act. We also proposed to use the FY 2009 wage index data (collected from cost reports submitted by hospitals for cost reporting periods beginning during FY 2005), to compute the ESRD composite payment rates effective beginning January 1, 2009.

(1) CY 2009 Classification of Certain New England Counties

We are addressing the change in the treatment of ``New England deemed counties'' (that is, those counties in New England listed in

Sec. 412.64(b)(1)(ii)(B) that were deemed to part of urban areas under section 601(g) of the Social Security Amendments of 1983), that were made in the FY 2008 IPPS final rule with comment period (72 FR 47337 through 47338). These counties include the following: Litchfield

County, Connecticut; York County, Maine; Sagadahoc County, Maine;

Merrimack County, New Hampshire; and Newport County, Rhode Island. Of these five ``New England deemed counties'', three (York County,

Sagadahoc County, and Newport County) are also included in the MSAs defined by OMB, and therefore, used in the calculations of the urban hospital wage index values reflected in the ESRD composite payment rates. The remaining two counties, Litchfield County and Merrimack

County, are geographically located in areas that are considered

``rural'' under the current IPPS and ESRD composite payment system labor market definitions, but have been previously deemed urban under the IPPS in certain circumstances as discussed below.

Page 69760

In the FY 2008 IPPS final rule with comment period, for purposes of

IPPS, Sec. 412.64(b)(1)(ii)(B) was amended such that the two ``New

England deemed counties'' that are still considered rural under the OMB definitions (Litchfield County, CT and Merrimack County, NH) are no longer considered urban effective for discharges occurring on or after

October 1, 2007, and therefore, are considered rural in accordance with

Sec. 412.64(b)(1)(ii)(C). For purposes of the ESRD wage index, we have recognized OMB's CBSA designations, as well as generally followed the policies under the IPPS with regard to the definitions for ``urban'' and ``rural'' for the wage index, but we do not to take into account

IPPS geographic reclassifications in determining payments under the composite payment system. Accordingly, to reflect our general policy for the ESRD wage index, these two counties will be considered

``rural'' under the ESRD composite payment system effective with the next update of the payment rates on January 1, 2009, and will no longer be included in urban CBSA 25540 (Hartford-West Hartford-East Hartford,

CT) and urban CBSA 31700 (Manchester-Nashua, NH), respectively.

(2) Multi-Campus Hospital Wage Index Data

In the CY 2008 ESRD composite payment system final rule (72 FR 66280), we established ESRD wage index values for CY 2008 calculated from the same data (collected from cost reports submitted by hospitals for cost reporting periods beginning during FY 2004) used to compute the FY 2008 acute care hospital inpatient wage index, without taking into account geographic reclassification under sections 1886(d)(8) and

(d)(10) of the Act. However, the IPPS policy that apportions the wage data for multi-campus hospitals was not finalized before the ESRD composite payment system final rule. Therefore, the CY 2008 ESRD wage index values reflected the IPPS wage data that were based on a hospital's actual location without regard to the urban or rural designation of any related or affiliated provider. Accordingly, all wage data from different campuses of a multi-campus hospital were included in the calculation of the CBSA wage index of the main hospital. In the proposed rule, we noted that the IPPS wage data used to determine the proposed CY 2009 ESRD wage index values were computed from wage data submitted by hospitals for cost reporting periods beginning in FY 2005, and reflect our policy adopted under the IPPS beginning in FY 2008, which apportions the wage data for multi-campus hospitals located in different labor market areas, CBSAs, to each CBSA where the campuses are located (see the FY 2008 IPPS final rule with comment period (72 FR 47317 through 47320)). Specifically, under the CY 2009 ESRD composite payment system, the wage index was computed using

IPPS wage data (published by hospitals for cost reporting periods beginning in 2005, as with the FY 2009 IPPS wage index). This resulted in the allocation of salaries and hours to the campuses of two multi- campus hospitals, with campuses that are located in different labor areas, one in Massachusetts and the other is Illinois. The ESRD wage index values proposed for CY 2009 in the following CBSAs are affected by this policy: Boston-Quincy, MA (CBSA 14484), Providence-New Bedford-

Falls River, RI-MA (CBSA 39300), Chicago-Naperville-Joliet, IL (CBSA 16974), and Lake County-Kenosha County, IL-WI (CBSA 29404). (Please refer to Addenda G and H of this final rule with comment period.)

For CY 2009, we will use the FY 2009 wage index data (collected from cost reports submitted by hospitals for cost reporting periods beginning during FY 2005) to compute the ESRD composite payment rates effective beginning January 1, 2009.

Although we solicited comments, we did not receive any comments on this section and are implementing these provisions in this final notice. (For a detailed explanation of the multi-campus and New England deemed counties policies, refer to the CY 2009 PFS proposed rule (73 FR 38531 through 38532)). c. Budget Neutrality Adjustment

Section 1881(b)(12)(E)(i) of the Act, as added by section 623(d) of the MMA, requires that any revisions to the ESRD composite rate payment system as a result of the MMA provision (including the geographic adjustment), be made in a budget neutral manner. This means that aggregate payments to ESRD facilities in CY 2008 should be the same as aggregate payments that would have been made if we had not made any changes to the geographic adjusters. We note that this BN adjustment only addresses the impact of changes in the geographic adjustments. A separate BN adjustment was developed for the case-mix adjustments currently in effect. As we did not propose any changes to the case-mix measures for CY 2009, the current case-mix BN adjustment will remain in effect for CY 2009. As in CY 2008, for CY 2009, we again proposed to apply a BN adjustment factor directly to the ESRD wage index values. As explained in the CY 2007 PFS final rule with comment period (71 FR 69687 through 69688), we believe this is the simplest approach because it allows us to maintain our base composite rates during the transition from the current wage adjustments to the revised wage adjustments described previously in this section. Because the ESRD wage index is only applied to the labor-related portion of the composite rate, we computed the BN adjustment factor based on that proportion (53.711 percent).

To compute the final CY 2009 wage index BN adjustment factor

(1.056689), we used the most current FY 2005 pre-floor, pre- reclassified, non-occupational mix-adjusted hospital data to compute the wage index values, treatment counts from the most current 2007 outpatient claims (paid and processed as of June 30, 2008), and geographic location information for each facility which may be found on the Dialysis Facility Compare Web page on the CMS Web site at http:// www.cms.hhs.gov/DialysisFacilityCompare/. The FY 2005 hospital wage index data for each urban and rural locale by CBSA may also be accessed on the CMS Web site at http://www.cms.hhs.gov/AcuteInpatientPPS/WIFN/ list.asp. The wage index data are located in the section entitled, ``FY 2009 Final Proposed Rule Occupational Mix Adjusted and Unadjusted

Average Hourly Wage and Pre-Reclassified Wage Index by CBSA.''

Using treatment counts from the 2007 claims and facility-specific

CY 2008 composite rates, we computed the estimated total dollar amount each ESRD provider would have received in CY 2008 (the 3rd year of the 4-year transition). The total of these payments became the target amount of expenditures for all ESRD facilities for CY 2009. Next, we computed the estimated dollar amount that would have been paid to the same ESRD facilities using the proposed ESRD wage index for CY 2009

(the 4th year of the 4-year transition). The total of these payments became the fourth year new amount of wage-adjusted composite rate expenditures for all ESRD facilities. Section 153(a) of the MIPPA updated section 1881(b)(12)(G) of the Act and revised payments to ESRD facilities. The revisions that are effective January 1, 2009 include an update of 1 percent to the composite rate component of the payment system, and the establishment of a site neutral composite rate to hospital-based and independent dialysis facilities. We note that when computing the 4th year new amount, we did not

Page 69761

include the MIPPA provisions because they are not budget neutral.

After comparing these two dollar amounts (target amount divided by the 4th year new amount), we calculated an adjustment factor that, when multiplied by the applicable CY 2009 ESRD wage index value, would result in aggregate payments to ESRD facilities that will remain within the target amount of composite rate expenditures. When making this calculation, the ESRD wage index floor value of 0.7000 is used whenever appropriate. The BN adjustment factor for the CY 2009 wage index is 1.056689. This figure differs slightly from the figure in the proposed rule (1.056672) because we have used updated hospital wage data and treatment counts from the most current claims data.

To ensure BN, we also must apply the BN adjustment factor to the wage index floor of 0.7000 which results in a adjusted wage index floor of 0.7397 (0.7000 x 1.056689) for CY 2009. d. ESRD Wage Index Tables

The 2009 wage index tables are located in Addenda G and H of this final rule with comment period. 6. Application of the Hospital-Acquired Conditions Payment Policy for

IPPS Hospitals to Other Settings

Value-based purchasing (VBP) ties payment to performance through the use of incentives based on measures of quality and cost of care.

The implementation of VBP is rapidly transforming CMS from being a passive payer of claims to an active purchaser of higher quality, more efficient health care for Medicare beneficiaries. Our VBP initiatives include hospital pay for reporting (the Reporting Hospital Quality Data for the Annual Payment Update), physician pay for reporting (the

Physician Quality Reporting Initiative), home health pay for reporting, the Hospital VBP Plan Report to Congress, and various VBP demonstration programs across payment settings, including the Premier Hospital

Quality Incentive Demonstration and the Physician Group Practice

Demonstration.

The preventable hospital-acquired conditions (HAC) payment provision for IPPS hospitals is another of our value-based purchasing initiatives. The principle behind the HAC payment provision (Medicare will not provide additional payments to IPPS hospitals to treat certain preventable conditions acquired during a beneficiary's IPPS hospital stay) could be applied to the Medicare payment systems for other settings of care. Section 1886(d)(4)(D) of the Act requires the

Secretary to select for the HAC IPPS payment provision conditions that are: (1) High cost, high volume, or both; (2) assigned to a higher paying Medicare Severity-Diagnosis Related Group (MS-DRG) when present as a secondary diagnosis; and (3) could reasonably have been prevented through the application of evidence-based guidelines. Beginning October 1, 2008, Medicare can no longer assign an inpatient hospital discharge to a higher paying MS-DRG if a selected HAC was not present, or could not be identified based on clinical judgment, on admission. That is, the case will be paid as though the secondary diagnosis related to the

HAC was not present. Medicare will continue to assign a discharge to a higher paying Medicare Severity-Diagnosis Related Group (MS-DRG) if a selected condition was present on admission.

The broad principle articulated in the HAC payment provision for

IPPS hospitals (that is, Medicare not paying more for certain reasonably preventable hospital-acquired conditions) could potentially be applied to other Medicare payment systems for conditions that occur in settings other than IPPS hospitals. Other possible settings of care include, but are not limited to: hospital outpatient departments, ambulatory surgical centers, SNFs, HHAs, ESRD facilities, and physician practices. Implementation would be different for each setting, as each payment system is different and the level of reasonable prevention through the application of evidence-based guidelines would vary for candidate conditions across different settings of care. However, alignment of incentives across settings of care is an important goal for all of our VBP initiatives, including the HAC payment provision.

A related application of the broad principle behind the HAC payment provision for IPPS hospitals could be considered through Medicare secondary payer policy by requiring the provider that failed to prevent the occurrence of a preventable condition in one setting to pay for all or part of the necessary follow up care in a second setting. This would help shield the Medicare program from inappropriately paying for the downstream effects of a reasonably preventable condition acquired in the first setting but treated in the second setting.

We note that we did not propose new Medicare policy in this discussion of the possible application of the HAC payment policy for

IPPS hospitals to other settings, as some of these approaches may require new statutory authority. Instead of proposing policy, we solicited public comment on the application of the preventable HAC payment provision for IPPS hospitals to other Medicare payment systems.

We also stated that we look forward to working with stakeholders in the fight against all healthcare-associated conditions.

The following is a summary of the comments we received and our responses.

Comment: Commenters recommended that CMS work with technical experts, such as physicians and hospitals, to determine the impact, burden, and accuracy of POA indicator reporting in the inpatient setting before it is expanded to other settings of care. Commenters specifically recommended that CMS consider issues of adverse selection and access to care for vulnerable populations. Many commenters had concerns with CMS' authority and ability to implement such a policy for the physician office setting.

Response: We agree that the HAC payment provision should be studied to determine its impact. We also recognize the importance of aligning

VBP policy across all Medicare payment systems. We believe it is appropriate to consider policies of not paying more for medical care that harms patients or leads to complications that could have been prevented. For example, we note that CMS is currently considering

National Coverage Determinations (NCDs) for three of the National

Quality Forum's Serious Reportable Events: (1) Surgery on the wrong body part, (2) surgery on the wrong patient, and (3) wrong surgery performed on a patient. NCDs can address physician services as well as institutional services. We will work with stakeholders as we move forward in combating healthcare-associated conditions in all Medicare payment settings. Any additional policies, within statutory authority, addressing these issues would be proposed through notice and comment rulemaking.

Comment: Some commenters stated that CMS may need to implement a

Present on Admission (POA)-type indicator to recognize healthcare- acquired conditions in the physician office and ESRD settings of care, similar to the IPPS POA indicator.

Response: We agree that a POA-type indicator would aid in determining the onset of a healthcare-acquired condition. We welcome the opportunity to work with stakeholders to consider expansion of a

POA-type indicator to all Medicare settings of care. We look forward to working with entities such as the National Uniform Billing Committee

(NUBC) on the implementation of a

Page 69762

POA-type indicator for all settings of care.

Comment: Many commenters identified attribution of a healthcare- acquired condition to an individual physician who is broadly managing the patient's care as a challenge in expanding the principle behind the

HAC payment provision to the physician office setting. Some commenters noted that several physicians may be responsible for the care of a patient, therefore attribution of the adverse event to a single physician may be difficult.

Response: We recognize that because health care is delivered by a team of professionals, several providers could potentially share responsibility for the occurrence of a healthcare-associated condition.

We have extensive experience in testing various attribution methodologies in our cost of care measurement initiative. We refer readers to section III.C. of this final rule with comment period

(section 131(c) of the MIPPA) for further discussion of attribution.

Comment: Some commenters expressed concern regarding implementation of the Medicare secondary payer policy to hold the provider in which a health-care associated condition occurred liable for the cost of subsequent care required to treat the condition.

Response: We appreciate the comments regarding MSP policy and payment for health-care associated conditions in downstream care settings. We look forward to further exploring these issues with stakeholders.

Comment: A few commenters recognized that the HAC payment provision targets a portion of an MS-DRG payment and were unsure how this concept could be transferred to the physician office setting. Further, several commenters mentioned bundled or global payment as a more rational way to pay for Medicare services, which could obviate the need for a healthcare-acquired condition payment provision.

Response: As commenters noted, the HAC payment provision prohibits payment for a portion of the MS-DRG when a HAC occurs in the inpatient setting. In that the HAC payment provision results in payment being adjusted to a lower level of payment, the basic payment concept could be made applicable to other Medicare payment settings. Implementation of such policies would likely depend on the specific coding and payment systems used for each payment system.

Comment: Several commenters expressed the need to adjust for patient-specific factors like severity of illness and patient compliance. A few commenters stated that unlike the inpatient setting, the physician office setting does not lend itself to close monitoring of patient compliance.

Response: We recognize that certain beneficiaries may pose a greater risk of contracting a healthcare-acquired condition. We also note that providers must carefully consider those risk factors to avoid preventable conditions. We refer readers to the FY 2009 Inpatient

Prospective Payment System final rule (73 FR 48487 through 48488

(http://edocket.access.gpo.gov/2008/pdf/E8-17914.pdf)) where we discussed risk-adjustment as a potential enhancement to the IPPS HAC provision.

Comment: Many commenters believe that it could be more effective to combat healthcare-acquired conditions by adjusting payments based on a provider's rates of healthcare-associated conditions rather than to directly adjust the payment for an individual service.

Response: We agree that capturing rates of healthcare-associated conditions and using those rates for performance-based payment may be a more sophisticated and effective way to adjust payment. Rates of healthcare-associated conditions may be good candidates as possible quality measures for VBP programs like the PQRI as discussed in more detail in section II.O. of this final rule with comment period.

Further, the ESRD pay-for-performance program and the forthcoming

Physician VBP Plan Report to Congress may also address healthcare- associated conditions.

Comment: Commenters raised concern regarding the use of financial incentives to combat healthcare-associated conditions. Many commenters suggested that CMS should encourage compliance with evidence-based guidelines rather than use direct payment adjustments to address healthcare-associated conditions in the physician office setting.

Response: We agree that it is important for Medicare providers to provide care that is consistent with evidence-based guidelines. We intend to consider all of our statutory and regulatory authorities, including the implementation of quality measures and payment adjustments, to encourage provision of care that is consistent with evidence-based guidelines. We look forward to working with stakeholders to further identify and apply available methods to combat healthcare- acquired conditions.

Comment: Many commenters supported the alignment of incentives across all Medicare settings of care.

Response: We appreciate the public's support of our efforts to align incentives across all Medicare payment settings. We look forward to working with stakeholders to expand VBP initiatives in all Medicare payment settings. Further, we intend to host a public listening session toward the end of CY 2008 to discuss the expansion of the HAC payment provision, specifically targeting both the inpatient and hospital outpatient department (HOPD) settings of care.

I. Independent Diagnostic Testing Facility (IDTF) Issues

In the CY 2007 and 2008 PFS final rules with comment period, we established performance standards for suppliers enrolled in the

Medicare program as an IDTF (71 FR 69695 and 72 FR 66285). These standards were established to improve the quality of care for diagnostic testing furnished to Medicare beneficiaries by a Medicare- enrolled IDTF and to improve our ability to verify that these suppliers meet minimum enrollment criteria to enroll or maintain enrollment in the Medicare program. These performance standards were established at

Sec. 410.33. In the proposed rule, we proposed to expand on the quality and program safeguard activities that we implemented previously. 1. Improving Quality of Diagnostic Testing Services Furnished by

Physician and Nonphysician Practitioner Organizations

During the CY 2008 PFS proposed rule comment period, we received comments requesting that we require that the IDTF performance standards adopted in Sec. 410.33, including prohibitions regarding the sharing of space and leasing/sharing arrangements, apply to physicians and nonphysician practitioners (NPPs) who are furnishing diagnostic testing services for Medicare beneficiaries, and who have enrolled in the

Medicare program as a clinic, group practice, or physician's office.

The commenters stated that standards for imaging services were not applied consistently for all imaging centers and that two distinct compliance and regulatory standards would emerge depending on how the similarly situated imaging centers were enrolled. In addition, one commenter stated that we should not prohibit space sharing when done with an adjoining physician practice or radiology group that is an owner of an IDTF. Because these comments were outside of the scope of the provisions in the CY 2008 PFS proposed rule, we were not able to take action regarding these comments in the

Page 69763

CY 2008 PFS final rule with comment period.

In the CY 2009 PFS proposed rule, we stated that we are concerned that--

Certain physician entities, including physician group practices, and clinics, can enroll as a group practice or clinic and furnish diagnostic testing services without the benefit of qualified nonphysician personnel, as defined in Sec. 410.33(c), to conduct diagnostic testing.

Some physician entities expect to furnish diagnostic testing services for their own patients and the general public and are making the decision to enroll as a group or clinic thereby circumventing the performance standards found in the IDTF requirements in Sec. 410.33.

Some physician organizations are furnishing diagnostic tests using mobile equipment provided by an entity that furnishes mobile diagnostic services.

Therefore, we proposed certain exceptions to the established performance standards found in Sec. 410.33(g) because we believe that physician organizations already meet or exceed some of these standards.

For example, their liability insurance coverage usually far exceeds the

$300,000 per incident threshold, and there are a host of ways in which patients may make clinical complaints concerning their physicians. In addition, we believe that compliance with some of the performance standards would be costly and burdensome and possibly limit beneficiary access, particularly in rural or medically underserved areas. For these reasons, we proposed that physician entities do not need to comply with the following standards:

Maintaining additional comprehensive liability insurance for each practice location as required under Sec. 410.33(g)(6).

Maintaining a formal clinical complaint process as required under Sec. 410.33(g)(8).

Posting IDTF standards as required under Sec. 410.33(g)(9).

Maintaining a visible sign posting business hours as required under Sec. 410.33(g)(14)(ii).

Separately enrolling each practice location as required under Sec. 410.33(g)(15)(i).

Accordingly, we proposed to add Sec. 410.33(j) which states that,

``A physician or NPP organization (as defined in Sec. 424.502) furnishing diagnostic testing services, except diagnostic mammography services: (1) Must enroll as an independent diagnostic testing facility for each practice location furnishing these services; and (2) is subject to the provisions found in Sec. 410.33, except for Sec. 410.33(g)(6), Sec. 410.33(g)(8), Sec. 410.33(g)(9), Sec. 410.33(g)(14)(ii), and Sec. 410.33(g)(15)(i).'' As discussed in section II.J. of this preamble, we proposed to define a ``physician or nonphysician practitioner organization'' as any physician or NPP entity that enrolls in the Medicare program as a sole proprietorship or organizational entity such as a clinic or group practice.

We maintained that this enrollment requirement is necessary to ensure that beneficiaries are receiving the quality of care that can only be administered by appropriately licensed or credentialed nonphysician personnel as described in Sec. 410.33(c). Moreover, we proposed that physician or NPP organizations that do not enroll as an

IDTF and meet the provisions at Sec. 410.33 may be subject to claims denial for diagnostic testing services or a revocation of their billing privileges.

We solicited comments on whether we should consider establishing additional exceptions to the established performance standards in Sec. 410.33(g) for physician and NPP organizations furnishing diagnostic testing services. We stated in the proposed rule that while we believe that most physician and NPP organizations utilize nonphysician personnel described in Sec. 410.33(c) to furnish diagnostic testing services, we also solicited comments on whether physician or NPPs conduct diagnostic tests without benefit of qualified nonphysician personnel and under what circumstances the testing occurs.

While we proposed to apply the IDTF requirement to all diagnostic testing services furnished in physicians' offices, we stated that we were considering whether to limit this enrollment requirement to less than the full range of diagnostic testing services, such as to procedures that generally involve more costly testing and equipment. We solicited comments about whether the policy should apply only to imaging services or whether it should also include other diagnostic testing services such as electrocardiograms or other diagnostic testing services frequently furnished by primary care physicians. Within the scope of imaging services, we solicited comments about whether the policy should be limited to advanced diagnostic testing procedures which could include diagnostic magnetic resonance imaging, computed tomography, and nuclear medicine (including positron emission tomography), and other such diagnostic testing procedures described in section 1848(b)(4)(B) of the Act (excluding X-ray, ultrasound, and fluoroscopy). We also solicited comments on what would be appropriate criteria to limit this provision.

Finally, since these changes, if adopted, would take time to implement for suppliers that have enrolled in the Medicare program, we proposed an effective date of September 30, 2009, rather than the effective date of the final rule with comment period. For newly enrolling suppliers, we proposed the effective date of this rule which is January 1, 2009.

With the enactment of section 135 of the MIPPA legislation and after reviewing public comments, we are deferring the implementation of these proposals while we continue to review the public comments received on this provision and we will consider finalizing this provision in a future rulemaking effort if we deem it necessary.

Section 135 of the MIPPA requires that the Secretary establish an accreditation process for those entities furnishing advanced diagnostic testing procedures which include diagnostic magnetic resonance imaging, computed tomography, and nuclear medicine (including positron emission tomography), and other such diagnostic testing procedures described in section 1848(b)(4)(B) of the Act (excluding X-ray, ultrasound, and fluoroscopy) by January 1, 2012.

Accordingly, we are not adopting our proposal to require physicians and NPPs to meet certain quality and performance standards when providing diagnostic testing services, except mammography services, within their medical practice setting and have removed the paperwork burden and regulatory impact analysis associated with this provision in this final rule with comment period. 2. Mobile Entity Billing Requirements

To ensure that entities furnishing mobile services are providing quality services and are billing for the diagnostic testing services they furnish to Medicare beneficiaries, we proposed a new performance standard for mobile entities at Sec. 410.33(g)(16), which would require that entities furnishing mobile diagnostic services enroll in

Medicare and bill directly for the mobile diagnostic services that they furnish, regardless of where the services are furnished. We believe that entities furnishing mobile diagnostic services to Medicare beneficiaries must be enrolled in the Medicare program, comply with the

IDTF performance standards, and directly bill Medicare for the services they furnish.

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While we understand that a mobile entity can furnish diagnostic testing services in various types of locations, we stated that we believe that it is essential that mobile entities use qualified physicians or nonphysician personnel to furnish diagnostic testing procedures and that the enrolled mobile supplier bill for the services furnished. We maintain that it is essential to our program integrity and quality improvement efforts that an entity furnishing mobile diagnostic testing services complies with the performance standards for

IDTFs and bill the Medicare program directly for the services furnished to Medicare beneficiaries.

Since we believe that most mobile entities are already billing for the services they furnish, whether the service was provided in a fixed- based location or in a mobile facility, we proposed that this provision would be effective with the effective date of this final rule with comment period.

Comment: Several commenters supported our proposal to require mobile diagnostic service providers to enroll in Medicare as IDTFs and to be required to bill Medicare directly for the TC services they furnish.

Another commenter stated that this provision creates a single, universal quality standard for outpatient imaging that eliminates any possible inequity in standards that could exist between office-based imaging and IDTF imaging.

Several other commenters support the concept that all providers and suppliers serving Medicare beneficiaries must be enrolled to be eligible to receive payments from Medicare, directly or indirectly.

Response: We agree with these comments and thank the commenters for their support.

Comment: One commenter stated that this provision would eliminate two distinct and unfair competitive advantages that mobile cardiac nuclear imaging providers enjoy under existing regulations. One advantage is the ability to operate under a ``mobile'' Nuclear

Regulatory Commission Radioactive Materials license, which does not require the same regulatory filings as fixed-site cardiac nuclear medicine laboratories, and in the case of some state Radioactive

Materials licenses, it does not subject the mobile provider to the same pre-opening inspections that the fixed sites are subject to. Second, some mobile providers are able to secure accreditation from certain accrediting agencies that furnish a global, or ``hub'', accreditation certification.

Response: We thank the commenter for its support.

Comment: One commenter stated that our proposal to require mobile providers to enroll in Medicare as IDTFs, be subject to all IDTF performance standards, and to bill Medicare directly, not only would it create a single, universal standard for quality among all imaging providers, but would also level the playing field in the competitive market for management services for companies which provide high quality fixed site programs for Medicare-enrolled physician practices and their

Medicare enrollees.

Response: We appreciate the comments and thank the commenter for their support.

Comment: One commenter supports the proposal requiring these entities to enroll in Medicare and as such, for them to be required to abide by applicable Medicare policies. The commenter continued to state that they do not oppose the direct billing requirement but that if the proposal is finalized, CMS needs to provide a great amount of detail in how the provision will work and its impact on hospital billing practices.

Response: We have revised the provision at Sec. 410.33(g)(17) for those IDTFs that are billing under arrangement with hospitals as described in section 1862(a)(14)of the Act and Sec. 482.12(e).

Comment: Several commenters urged CMS to clarify that its proposal to require mobile testing entities to bill directly for services they furnish would not apply when such services are furnished ``under arrangement to hospital inpatients and outpatients.'' In addition, these commenters recommended that mobile diagnostic testing facilities that furnish these services to hospitals be excluded from the proposed

IDTF performance standards.

Response: Although we are requiring all mobile entities that furnish diagnostic testing services to enroll in the Medicare program, we are not requiring mobile testing entities to bill directly for the services they furnish when such services are furnished under arrangement with hospitals as described in sections 1861(w)(1) and 1862(a)(14)of the Act and Sec. 482.12(e).

Comment: One commenter urges CMS to exclude from the definition of entities furnishing mobile diagnostic testing services those entities that do the following: lease equipment and provide technicians who conduct diagnostic tests in the office of the billing physician or physician organization; and furnish testing under the supervision of a physician who shares an office with the billing physician or physician organization.

Response: We disagree with the commenter. We maintain that a mobile entity providing diagnostic testing services must enroll for any diagnostic imaging services that it furnishes to a Medicare beneficiary, regardless of whether the service is furnished in a mobile or fixed base location so that CMS knows which entity is providing these diagnostic testing services.

Comment: One commenter stated that the proposed IDTF performance standard is contrary to the Medicare ``under arrangement'' provisions and if the IDTF performance standard were extended into the hospital setting, it would prohibit hospitals from providing diagnostic imaging services under arrangement and present significant administrative and operational challenges for hospitals and their patients.

Response: We agree and have revised the provision to account for mobile IDTFs billing under arrangement with hospitals as described in sections 1861(w)(1) and 1862(a)(14)of the Act and Sec. 482.12(e).

Comment: Several commenters requested that we not require mobile units that furnish diagnostic testing services to enroll in Medicare or be required to bill for all of the services they furnish.

Response: We disagree with the commenters. In order to maintain program integrity and enable CMS to monitor services furnished by mobile units providing diagnostic testing services, we maintain that a mobile entity providing diagnostic testing services must enroll for diagnostic imaging services that it furnishes to a Medicare beneficiary, regardless of whether the service is furnished in a mobile or fixed base location. We are requiring these mobile IDTFs to bill for the services that they furnish unless they are billing under arrangement with hospitals.

Comment: One commenter stated the contractual arrangement between mobile diagnostic imaging services companies and hospitals are commonplace throughout the United States health care industry and these long-standing arrangements, which can be short-term or long-term depending upon hospital demand, service a variety of important needs within the hospital and provider community, including a valuable means to address capacity, volume and equipment cost issue and limitations imposed by State Certificate of Need (CON) requirements.

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Response: We understand the commenters' concerns and we are requiring these mobile IDTFs to bill for the services that they furnish unless they are billing under arrangement with hospitals.

Comment: One commenter suggested that we should provide clear and concise guidance on billing protocols that permit hospitals to continue billing for mobile diagnostic testing services furnished as inpatient and outpatient hospital services and allow informational billing (that is, no payment impact) by the mobile entities through the use of a billing modifier.

Response: We believe these comments are outside the scope of the rule.

Comment: One commenter does not support a restriction of an enrolled provider/supplier that would preclude them from arrangements that are allowed under the purchased diagnostic test or purchased interpretation rules due to their method of connecting a patient with testing equipment.

Response: We understand the commenters' concerns and we are requiring these mobile IDTFs to bill for the services they furnish unless they are billing under arrangement with hospitals.

Comment: One commenter states that they believe that the provision of diagnostic and other therapeutic services by a contracted provider to registered inpatients and outpatients is fully consistent with longstanding Medicare provisions expressly permitting hospitals to furnish services directly or ``under arrangements,'' and that the mobile entities that may furnish these services under arrangement would not bill directly for their services but would be under the control of another entity.

Response: We agree with the commenter and although we are requiring all mobile entities that provide diagnostic testing services to enroll in the Medicare program, we are not requiring mobile testing entities to bill directly for the services they furnish when such services are furnished under arrangement to hospitals.

After reviewing public comments, we are finalizing the provision at

Sec. 410.33(g)(16), which would require that entities furnishing mobile diagnostic services enroll in Medicare program as an IDTF regardless of where the services are furnished. By enrolling in the

Medicare program, CMS or our contractor can determine if the mobile

IDTF meets all of the performance standards found in Sec. 410.33(g) and that its owners are not otherwise excluded or barred from participation in the Medicare program. We believe that requiring mobile

IDTFs to enroll in order to furnish services to Medicare beneficiaries is consistent with the existing enrollment regulation found at Sec. 424.505 which states that to receive payment for covered Medicare items or services from either Medicare or a Medicare beneficiary, a provider or supplier must be enrolled in the Medicare program. Moreover, by requiring mobile IDTFs to enroll in order to furnish services to

Medicare beneficiaries, the Medicare contractor will be able to certify that mobile IDTFs are in compliance with the requirements for enrolling and maintaining enrollment set forth at Sec. 424.520. Finally, the owner of a mobile IDTF is responsible for ensuring that the mobile IDTF meets all applicable regulatory requirements to maintain their enrollment in the Medicare program.

In addition, we are finalizing the provision at Sec. 410.33(g)(17) requiring that mobile diagnostic services bill for the mobile diagnostic services that they furnish, unless the mobile diagnostic service is part of a hospital service and furnished under arrangement with that hospital as described in section 1862(a)(14)of the Act and

Sec. 482.12(e). To ensure that IDTFs are actually furnishing services under arrangement with a hospital, we will require that mobile IDTFs provide documentation of the arrangement with their initial or revalidation enrollment application, or change in enrollment application. 3. Revocation of Enrollment and Billing Privileges of IDTFs in the

Medicare Program

Historically, we have allowed IDTFs whose Medicare billing numbers have been revoked to continue billing for services furnished prior to revocation for up to 27 months after the effective date of the revocation. Since we believe that permitting this extensive billing period poses a significant risk to the Medicare program, we proposed to limit the claims submission timeframe after revocation. In Sec. 424.535(g) (redesignated as Sec. 424.535(g)), we proposed that a revoked IDTF must submit all outstanding claims for not previously submitted items and services furnished within 30 calendar days of the revocation effective date. We stated that this change is necessary to limit the Medicare program's exposure to future vulnerabilities from physician and NPP organizations and individual practitioners that have had their billing privileges revoked. Accordingly, the proposed change would allow a Medicare contractor to conduct focused medical review on the claims submitted during the claims filing period to ensure that each claim is supported by medical documentation that the contractor can verify. We maintain that focused medical review of these claims will ensure that Medicare only pays for services furnished by a physician or NPP organization or individual practitioner and that these entities and individuals receive payment in a timely manner. In addition, we also proposed to add a new provision at Sec. 424.44(a)(3) to account for this provision related to the requirements for the timely filing of claims. The timely filing requirements in Sec. 424.44(a)(1) and (a)(2) will no longer apply to physician and NPP organizations, physicians, NPPs and IDTFs whose billing privileges have been revoked by CMS.

Comment: Several commenters recommended that we withdraw all of our proposed changes to the requirements for physician enrollment in

Medicare, including changes to the effective date of billing privileges, eligibility to participate in the program, enrollment processing, reporting requirements, and revocation of billing privileges. Many of the commenters were concerned that it would be burdensome to add new requirements where they must submit all claims within 60 days of the effective date of revocation because of the time it takes to process claims and that it would be easier to leave the retrospective billing rules as they are.

Response: We are not adopting this recommendation. Instead, we will respond to the specific comments received in response to our specific proposals.

Comment: Several commenters requested that we make no revisions to current physician and NPP enrollment rules at this time.

Response: We are not adopting this recommendation. Instead, we will respond to the specific comments received in response to our specific proposals.

After reviewing public comments, we are finalizing the provisions found at Sec. 424.535(h) (formerly Sec. 424.535(g)) that require a revoked physician organization, a physician, a NPP, or an IDTF to submit all outstanding claims not previously submitted within 60 calendar days of the revocation effective date. Since IDTFs are already afforded approximately 30 days notification before the effective date of revocation (except for revocations identified in Sec. 405.874(b)(2) and Sec. 424.535(f) of this final rule), we believe that almost 90 days is more than sufficient time to file any outstanding claims.

In addition, we are finalizing the provisions found at Sec. 424.44(a) related

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to the requirements for the timely filing of claims. The timely filing requirements in Sec. 424.44(a)(1) and (a)(2) will no longer apply to physician and NPP organizations, physicians, NPPs or IDTFs. We revised this provision so that it is consistent with Sec. 424.521 which limits the ability of these suppliers to bill Medicare retrospectively.

J. Physician and Nonphysician Practitioner (NPP) Enrollment Issues 1. Effective Date of Medicare Billing Privileges

In accordance with Sec. 424.510, physician and NPP organizations

(that is, groups, clinics, and sole owners) and individual practitioners including physicians and NPPs, operating as sole proprietorships or reassigning their benefits to a physician and nonphysician organization may submit claims as specified in Sec. 424.44 after they are enrolled in the Medicare program. This provision permits newly enrolled physician and NPP organizations and individual practitioners, as well as existing physicians and nonphysician organizations and individual practitioners to submit claims for services that were furnished prior to the date of filing or the date the applicant received billing privileges to participate in the

Medicare program.

For the purposes of this final rule with comment period, we believe that an NPP includes, but is not limited to, the following individuals: anesthesiology assistants, audiologists, certified nurse midwives, certified registered nurse anesthetists (CRNA), clinical social workers, nurse practitioners (NPs), physician assistants (PAs), clinical psychologists, psychologists billing independently, speech language pathologists, and registered dieticians or nutrition professionals.

Once enrolled, physician and NPP organizations and individual physicians and NPPs, depending on their effective date of enrollment, may retroactively bill the Medicare program for services that were furnished up to 27 months prior to being enrolled to participate in the

Medicare program. For example, if a supplier is enrolled in the

Medicare program in December 2008 with an approval date back to October 2006, that supplier could retrospectively bill for services furnished to Medicare beneficiaries as early as October 1, 2006.

Currently, physician and NPP organizations and individual practitioners, including physicians and NPPs, are allowed to bill

Medicare prior to their enrollment date. Therefore, it is possible that the physician and NPP organizations and individual practitioners who meet our program requirements on the date of enrollment may not have met those same requirements prior to the date of enrollment, even though that supplier could bill Medicare and receive payments for services furnished up to 27 months prior to their enrolling in the

Medicare program. In the proposed rule, we stated our concern that some physician and NPP organizations and individual practitioners may bill

Medicare for services when they are not meeting our other program requirements, including those related to providing beneficiary protections, such as Advance Beneficiary Notices.

We solicited public comment on two approaches for establishing an effective date for Medicare billing privileges for physician and NPP organizations and for individual practitioners.

The first approach would establish the initial enrollment date for physician and NPP organizations and for individual practitioners, including physician and NPPs, as the date of approval by a Medicare contractor. This approach would prohibit physician and NPP organizations and individual practitioners from billing for services furnished to a Medicare beneficiary before they are approved and enrolled by a designated Medicare contractor to participate in the

Medicare program and Medicare billing privileges are conveyed to their

National Provider Identifier (NPI). Physicians and NPPs are eligible for NPIs and may apply for their NPIs at any time. To enroll in

Medicare, a physician or NPP must have an NPI. If an enrollment application is received that is absent the NPI, it will be rejected.

The NPI regulation, at 45 CFR 162.410(a)(1), requires a health care provider who is a covered entity under HIPAA to obtain an NPI. At 45

CFR 162.410(b), the NPI regulation states that a health care provider who is not a covered entity under HIPAA may obtain an NPI. The definition of ``health care provider'' is found at 45 CFR 160.103. The preamble of the NPI final rule (69 FR 3450) states that HIPAA does not prohibit a health plan from requiring its enrolled health care providers to obtain NPIs if those health care providers are eligible for NPIs (that is, that they meet the definition of ``health care provider''). With exceptions for the two entities that are eligible to enroll in Medicare but are not eligible for NPIs, Medicare requires all providers, including physicians and NPPs, who apply for enrollment to have NPIs, and to report them on their Medicare enrollment applications. When applying for NPIs, providers indicate they are one of the following: An Entity type 1 (an individual person, such as a physician or an NPP, to include a sole proprietor/sole proprietorship); or an Entity type 2 (an organization, which is any legal entity other than an individual).

The date of approval is the date that a designated Medicare contractor determines that the physician or NPP organization or individual practitioner meets all Federal and State requirements for their supplier type

Given this first approach, in proposed Sec. 424.520, we stated that we may implement regulations text that reads similar to: ``The effective date of billing privileges for physician and NPP organizations and individual practitioners, including physicians and

NPPs, is the date a Medicare contractor conveys billing privileges to a

NPI.''

We also stated in the CY 2009 PFS proposed rule that we believe that this approach--

Prohibits physicians, NPP organizations, and individual practitioners from receiving payments before a Medicare contractor conveys Medicare billing privileges to an NPI (69 FR 3434);

Is consistent with our requirements in Sec. 489.13 for those providers and suppliers that require a State survey prior to being enrolled and the requirements for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) suppliers in Sec. 424.57(b)(2);

Is consistent with our requirements for providers identified in Sec. 400.202 and surveyed suppliers that are allowed to bill for services only after they are approved to participate in the

Medicare program. Surveyed suppliers are those suppliers who have been certified by either CMS or a State certification agency and are in compliance with Medicare requirements. Surveyed suppliers may include

ASCs or portable x-ray suppliers; and

Ensures that we are able to verify a supplier's qualifications, including meeting any performance standards before payment for services can occur.

The second approach would establish the initial enrollment date for physician and NPP organizations and individual practitioners, including physician and NPPs, as the later of: (1) The date of filing of a

Medicare enrollment application that was subsequently approved by a fee-for-service (FFS) contractor; or (2) the date an enrolled supplier first started furnishing services at a new practice location. The date of filing the enrollment application is the date that the Medicare FFS contractor receives a signed Medicare enrollment application that the

Medicare FFS

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contractor is able to process to approval. This option would allow a supplier that is already seeing non-Medicare patients to start billing for Medicare patients beginning on the day they submit an enrollment application that can be fully processed. In contrast to the first option, newly enrolling physicians and NPP organizations, and individual practitioners or physician and NPP organizations and individual practitioners that are establishing or changing a practice location would be allowed to bill the Medicare program for services furnished to Medicare beneficiaries on or after the date of filing if a

Medicare contractor approves Medicare billing privileges and conveys billing privileges to an NPI. It is also important to note that if a

Medicare contractor rejects or denies an enrollment application, then the physician or NPP organization or individual practitioner is at risk of not receiving payment for any services furnished after the date of filing.

Given this second approach, in proposed Sec. 424.520, we stated that we may implement regulations text that reads similar to: ``The effective date of billing privileges for physician and NPP organizations and for individual practitioners, physicians and NPPs, is the later of--(1) The filing date of the Medicare enrollment application that was subsequently approved by a FFS contractor; or (2)

The date that the physician or NPP organization or individual practitioner first furnished services at a new practice location.''

We also stated in the CY 2009 PFS proposed rule that we believe that this approach--

Prohibits physician and NPP organizations and individual practitioners, including physician and NPPs, from receiving payments before a Medicare contractor conveys Medicare billing privileges to an

NPI (69 FR 3434);

Is consistent with our requirements found at Sec. 410.33(i) that limit the retrospective billing for IDTFs and ensures that Medicare billing privileges are conveyed to physician and NPP organizations and to individual physicians and NPPs in a similar manner similar to IDTFs; and

Addresses the public's concern regarding contractor processing timeliness while appropriately ensuring that Medicare payments are made to physician and NPP organizations and to individual physicians and NPPs who have enrolled in a timely manner.

We maintain that it is not possible to verify that a supplier has met all of Medicare's enrollment requirements prior to submitting an enrollment application. Therefore, the Medicare program should not be billed for services before the later of the two dates that a physician or NPP organization, physician, or NPP has submitted an enrollment application that can be fully processed or when the enrolled supplier is open for business.

To assist physician and NPP organizations and individual practitioners in enrolling and updating their existing enrollment record, we established an Internet-based enrollment process known as the Internet-based Provider Enrollment, Chain and Ownership System

(PECOS) that is more streamlined and efficient than the traditional paper-application enrollment method.

By using Internet-based PECOS, we expect that physician and NPP organizations and individual practitioners will be able to reduce the time necessary to enroll in the Medicare program or to make a change in their Medicare enrollment record by reducing common errors in the application submission process. We expect that Medicare contractors will fully process most complete Internet-based PECOS enrollment applications within 30 to 45 calendar days compared to 60 to 90 calendar days in the current paper-based enrollment process. Thus, if physician and NPP organizations and individual practitioners enroll in the Medicare program or make a change in their existing Medicare enrollment using Internet-based PECOS and submit required supporting documentation, including a signed certification statement, licensing and education documentation, and, if necessary, the electronic funds transfer authorization agreement (CMS-588) 45 days before their effective date, a Medicare contractor should be able to process the enrollment application without a delay in payment.

The date of filing for Internet-based PECOS will be the date the

Medicare FFS contractor receives all of the following: (1) A signed certification statement; (2) an electronic version of the enrollment application; and (3) a signature page that the Medicare FFS contractor processes to approval.

In Sec. 424.502, we also proposed to define a physician and NPP organization to mean any physician or NPP entity that enrolls in the

Medicare program as a sole proprietorship or organizational entity such as a clinic or a group practice. In addition to establishing an organizational structure as a sole proprietorship, physicians and NPPs are able to establish various organizational relationships including corporations, professional associations, partnerships, limited liability corporations, and subchapter S corporations. We believe that the proposed definition would include sole proprietorships that receive a type 1 NPI and any organizational entity that is required to obtain a type 2 NPI.

Comment: Several commenters urged CMS to adopt the proposal to limit retrospective billing to the later of the date of filing or date the practice location was established.

Response: We agree with these commenters and have finalized this approach in this final rule with comment period.

Comment: One commenter recommended that we should not implement the revised effective date for billing privileges until January 1, 2010.

Response: We disagree with the commenter because we believe that it is essential that Medicare only pay for services to eligible practitioners that are qualified to bill for services.

Comment: Several commenters recommended that we refrain from implementing any proposed changes to the effective date of Medicare billing privileges until the Provider Enrollment, Chain and Ownership

System (PECOS) system is fully functional and a thorough discussion is held between all affected parties and/or all current National Provider

Identifier (NPI) applications are processed.

Response: While we understand this comment, we disagree with these commenters. By establishing an effective date of billing for physicians, NPPs, and physician and NPP organizations, we believe that

Medicare will only pay for services furnished by licensed practitioners that meet all of the Medicare program requirements. In addition, we implemented the NPI on May 23, 2008. Accordingly, we do not believe that there is a nexus between the implementation of the effective date for physicians, NPPs, and physician and NPP organizations and the implementation of the Internet-based PECOS or the implementation of the

NPI.

Comment: One commenter suggested that payment not commence until the provider's application has been processed and approved and that if the approval date is after the date the provider first started to render services, then payments will be paid retroactive to the rendering date. The commenter also requested that CMS implement an electronic enrollment processing system.

Response: We are finalizing a provision that allows physicians,

NPPs (including CRNAs), and physician or NPP organizations to retrospectively bill

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for services up to 30 days prior to their effective date of billing when the physician or NPP organization met all program requirements, including State licensure requirements, where services were provided at the enrolled practice location prior to the date of filing and circumstances precluded enrollment in advance of providing services to

Medicare beneficiaries in Sec. 424.521(a)(1). Further, we are implementing Internet-based PECOS for physicians and NPPs by the end of

CY 2008 to facilitate the electronic enrollment process.

Comment: One commenter suggested that the enrollment payment policy for CRNAs remain as it is.

Response: We are finalizing a provision that allows physicians,

NPPs (including CRNAs), and physician or NPP organizations to retrospectively bill for services up to 30 days prior to their effective date of billing when the physician or nonphysician organization has met all program requirements, including State licensure requirements, where services were provided at the enrolled practice location prior to the date of filing and circumstances, such as, when a physician is called to work in a hospital emergency department which precluded enrollment in advance of providing services to Medicare beneficiaries in Sec. 424.521(a)(1).

Comment: One commenter would like to recommend that CMS not make the new Web-based enrollment system too cumbersome. Their concerns are based on current member experiences with the IACS for review of PQRI claims. The requirements for the practice to designate a security officer, submit old IRS documents, etc., are extremely time-consuming, burdensome and serve as disincentives to physician participation.

Response: This comment is outside the scope of the proposed rule and cannot be addressed within this final rule.

Comment: One commenter asked that if we adopt either of these enrollment strategies, we should consider an exemption for hospital- based emergency physicians and NPP organizations to allow a period of retroactive billing and payment once an enrollment application is approved by the contractor.

Response: We are finalizing a provision that allows physicians,

NPPs, and physician or NPP organizations to retrospectively bill for services up to a 30 days prior to their effective date of billing when the physician or NPP organization met all program requirements, including State licensure requirements, where services were furnished at the enrolled practice location prior to the date of filing and circumstances precluded enrollment in advance of providing services to

Medicare beneficiaries in Sec. 424.521(a)(1).

Comment: One commenter stated that they support our efforts to ensure participating providers and suppliers of services are complying with Medicare program requirements in a matter consistent with policy and are not attempting to ``game'' the system. However, should we move forward with this proposal, the commenter advises the drafting of policies to identify unusual activities beyond the control of the provider or supplier, such as hurricanes and other natural disasters, that necessitate a provider or supplier of services obtaining additional Medicare billing privileges in order to provide services.

Response: We are finalizing a provision that allows physicians,

NPPs, physician or NPP organizations to retrospectively bill for services up to a 90 days prior to their effective date of billing when the physician or NPP organization met all program requirements, including State licensure requirements, services were furnished at the enrolled practice location prior to the date of filing and a

Presidentially-declared disaster under the Robert T. Stafford Disaster

Relief and Emergency Assistance Act, 42 U.S.C. Sec. Sec. 5121-5206

(Stafford Act) precluded enrollment in advance of providing services to

Medicare beneficiaries in Sec. 424.521(a)(2).

Comment: A large number of commenters do not support either approach and go further to state that both proposals will negatively impact the ability of hospital emergency departments and their physicians to meet their statutory obligations under the Emergency

Medical Treatment and Active Labor Act (EMTALA). Many of these commenters stated that in these emergency department situations, physicians are hired in very short timeframes, sometimes just days before they begin working in a new location that they cannot submit an enrollment application in such a short timeframe. They also continued to state that if we adopted the enrollment provisions as proposed, these emergency department enrollment situations would cause the physicians to forgo payment because they would not be able to submit an enrollment application before they begin furnishing services. Other commenters were opposed to both proposed approaches to limit retrospective billing after enrolling in the Medicare program and asked that we withdraw any proposed changes to the enrollment process.

Response: We disagree with the commenters. We believe that we have adopted an approach that balances the need to strengthen the Medicare enrollment process, protect the Medicare Trust Funds, and ensure that individual practitioners and physician and NPP organizations receive payment for services furnished to Medicare beneficiaries. The revised provision allows up to 30 days after furnishing services to submit an enrollment application (and up to 90 days when a Presidentially- declared disaster under the Robert T. Stafford Disaster Relief and

Emergency Assistance Act, 42 U.S.C. 5121-5206 (Stafford Act)) so the physician, NPP or physician or NPP organization has sufficient time to submit their enrollment application.

Comment: One commenter stated that they believe that it is unreasonable to expect physicians to furnish care to their patients without the ability to be paid for their services until they are officially enrolled in the Medicare program.

Response: While we agree that physicians should be reimbursed for the services furnished to Medicare beneficiaries, we also believe that physicians, NPPs and physician and NPP organizations are responsible for enrolling or making a change in their enrollment in a timely manner. In most cases, we believe that physicians and NPP practitioners can submit an enrollment application prior to providing Medicare services at a new practice location.

Comment: One commenter stated that in emergency room situations these enrollment scenarios will not work and gives the example using the second approach of when an emergency department is in desperate need of a provider. The department is able to obtain a physician almost immediately who is already employed within the organization and is also an approved provider in the Medicare program at their current practice location. Simply because the events in this example happened so quickly, the physician's CMS-855R was submitted to the Medicare contractor 1 week after he began providing services in the emergency department. If the second approach were in effect, 1 week of services the physician furnished to Medicare beneficiaries in the emergency department would be denied as his enrollment at this location was not in effect.

Response: We understand this commenter's concerns and are finalizing a provision that allows physicians, NPPs, physician or NPP organizations to retrospectively bill for services up to 30

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days prior to their effective date of billing when the physician or NPP organization met all program requirements, including State licensure requirements, where services were furnished at the enrolled practice location prior to the date of filing and circumstances precluded enrollment in advance of providing services to Medicare beneficiaries in Sec. 424.521(a)(1).

Comment: One commenter stated that should we adopt the second approach, they requested that a standard be established that defines what constitutes the receipt of a substantially complete application form for which the effective date under approach two may be established. This approach would address the situations where denial errors and clarifications can be corrected without delaying the effective date.

Response: As a general rule, applicants are given at least 30 days to cure any deficiencies/technicalities before a contractor rejects an enrollment application (see Sec. 424.525). During the application review process, contractors notify applicants about missing information and documentation and afford the applicant at least 30 days to correct deficiencies. With the implementation of Internet-based PECOS, we expect that physicians and NPPs using the Web process will significantly decrease the number of incomplete applications and the need for contractors to request additional information. With the implementation of this final rule, we would require contactor to deny, rather than reject paper or Web applications when a physician, NPP, or physician or NPP organization fails to cure any deficiencies/ technicalities.

Comment: One commenter urged CMS to adopt a standard establishing that the filing date for an enrollment application is when a signed application is first received by a contractor and not when the application is deemed complete and ready for approval by that contractor. Otherwise, delays associated with contractor processing could become a larger concern.

Response: We agree with this commenter and have adopted the ``date of filing'' as the date that the Medicare contractor receives a signed provider enrollment application that the Medicare contractor is able to process to approval.

Comment: Several commenters strongly opposed the approach where billing privileges would be conveyed based on the date of approval by the Medicare contractor and maintain that tying billing privileges to a contractor's approval of a practitioner's Medicare enrollment application could create unintended access problems for some patients.

Other commenters added that in certain situations, the physicians would furnish services and would not be able to be compensated which they do believe is an unintended consequence by CMS.

Response: We agree with the commenters and have not adopted the proposed approach as it was proposed but revised it so that it would establish the effective date of billing for physicians, NPPs, and physician and NNP organizations as the later of date of filing of a

Medicare enrollment application that was subsequently approved by a

Medicare contractor or the date they first began furnishing services at a new practice location.

Comment: The suggestion to use the Medicare contractor's date of approval as the initial enrollment date would mean that an employer can expect to generate no revenue from a new hire for a minimum of 3 to 6 months, which is unacceptable.

Response: As stated above, we have not adopted the proposed approach but revised it so that it would establish the effective date of billing for physicians, NPPs, and physician and NNP organizations as the later of date of filing of a Medicare enrollment application that was subsequently approved by a Medicare contractor or the date they first began furnishing services at a new practice location.

Comment: One commenter supports the establishment of an effective billing date for physicians, NPPs, and physician and NPP organizations as the later of: (1) The date of filing of a Medicare enrollment application that was subsequently approved by a Medicare contractor; or

(2) the date an enrolled physician or NPP first started furnishing services at a new practice location. The commenter further urges the agency to tie enrollment and when billing privileges begins to offering services at a new practice location.

Response: We appreciate this comment and have adopted a modified approach where that date of filing is the effective date of billing for physicians, NPPs, and physician and NPP organizations.

Comment: One commenter requests that current procedures change and allow enrollment applications to be submitted 60 days prior to a change.

Response: We disagree with the commenter and maintain that permitting billing 30 days before the filing of an enrollment application will provide a sufficient amount of time in most cases.

Comment: One commenter stated that the establishment of an effective billing date for physicians, NPPs, and physician and NPP organizations as: (1) The date of filing of a Medicare enrollment application that was subsequently approved by a Medicare contractor; or

(2) the date an enrolled physician or NPP first started furnishing services at a new practice location will improve patient access to

Medicare providers, since patients could be scheduled for appointments based on the date that a Medicare provider submits an enrollment application to the Medicare Administrative Contractor (MAC). This also allows new Medicare providers more flexibility when initiating services under Medicare.

Response: We thank the commenter for their support of this provision.

Comment: Several commenters recommend that providers should be able to submit enrollment applications with a requested effective date.

Response: We believe limiting retrospective payments will ensure that physicians, NPPs, and physician and NPP organizations will ensure that only qualified practitioners are able to bill for services furnished to Medicare beneficiaries. Moreover, we believe that establishing an effective date of Medicare billing privileges and establishing limited retrospective payments will encourage physicians,

NPPs, and physician and NPP organizations to enroll and maintain their enrollment in with the Medicare program. However, the effective date of billing privileges is 30 days prior to the later of the date an enrollment application is filed or the date services were furnished at a new practice location.

Comment: Several commenters urged CMS to retain its current retrospective billing policy for physicians and NPPs. However, these commenters stated that if CMS revised its retrospective billing policy for physicians, NPPs, and NPP organizations that they preferred option 2 (establishment of an effective billing date for physicians, NPPs, and physician and NPPs as the later of: (1) The date of filing of a

Medicare enrollment application that was subsequently approved by a

Medicare contractor; or (2) the date an enrolled physician or NPP first started furnishing services at a new practice location), which limited retrospective billing to the later of the date of filing or the date the practice location was established.

Response: We agree with these commenters and have adopted this approach in this final rule.

Comment: One commenter recommends allowing those physicians

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who are about to complete their fellowship to submit an application to

Medicare for a generic provider number which at a later date can be linked to an eventual employer.

Response: Since we do not establish a provisional enrollment status for physicians or other suppliers, but rather convey billing privileges to a NPI, we disagree with this commenter.

Comment: One commenter suggests that to improve the Medicare enrollment process, the processing of enrollment applications should take 30 to 45 days versus a 90 to 120 days activity. Medicare could follow the process employed by private payers and utilize one central repository for provider enrollment given that all processes basically require the same essential information.

Response: CMS already utilizes a single national repository of enrollment information. The national enrollment repository is known as the Provider Enrollment, Chain and Ownership System (PECOS).

Comment: Several commenters supported our proposed approach that would establish the initial enrollment date for individual practitioners and physician and NPP organizations as the date an enrolled supplier started furnishing services at the new practice location as it would be the fairest option for all enrollees.

Response: We appreciate this comment, and as stated above, we are finalizing this proposal with revisions so that it would establish the effective date of billing for physicians, NPPs, and physician and NNP organizations as the later of date of filing of a Medicare enrollment application that was subsequently approved by a Medicare contractor or the date they first began furnishing services at a new practice location.

Comment: One commenter stated that physician practices that allow new practitioners to treat Medicare patients before their applications are approved run the risk of submitting an application that is ultimately returned on a technicality, forcing them to begin the application process all over again.

Response: As stated above, to address the concern that enrollment applications are returned based on a technicality, we expect that physicians and NPPs using the Web process will significantly decrease the number of incomplete applications and the need for contractors to request additional information. With the implementation of this final rule, we would require contactor to deny, rather than reject paper or

Web applications when a physician, NPP, or physician or NPP organization fails to cure any deficiencies/technicalities.

Comment: One commenter stated that new physicians' practices must begin paying rent, salaries and other expenses the minute they become operational, if not before. This commenter also stated that many of these physicians are already forced to take out loans to pay expenses in the early days of operation until they enroll and can bill for services furnished in the interim. Finally, this commenter stated that our proposal to limit retrospective billing to the later of the date of filing or the date the practice location is operational will inhibit the ability of physicians and NPPs to create their own organizations, and instead, it will force them to join already existing entities.

Response: We do not believe that the Medicare program pays for services rendered prior to the date a new practice location is established. As described above, the physician or NPP would be allowed to file his or her enrollment application 30 days prior to the opening of new practice location and receive payments for services provided from the day the practice location was established or opened assuming that the physician met State licensing requirements and other Medicare program requirements at the time of filing and subsequently thereafter.

Comment: One commenter urged CMS to withdraw any proposed changes to the enrollment process, but stated that they would consider supporting limiting retrospective billing to the later of the date of filing or the date the practice location is operational but only after

Internet-based PECOS has been proven to facilitate timely enrollment processing (fewer than 30 days). Another commenter supported CMS implementing this requirement once the enrollment processing time is at a period of 30 to 45 days.

Response: We do not believe that a change to the effective date of

Medicare billing privileges has a nexus to the implementation of the

Internet-based PECOS.

Comment: One commenter suggested that we allow 30 to 60 days before submission of an application to serve as the date of approval because this timeline will allow for practices to obtain provider signatures, licenses, and certifications so that we can approve back to the date of licensure and/or the date the provider started furnishing services with a minimum of 30 to 60 days.

Response: We disagree with this commenter, because physicians, NPPs and physician and NPP organizations should have all the necessary licenses/certifications at the time of filing, not 30 or 60 days after filing an enrollment application.

Comment: Several commenters asked for clarification of the ``date of filing'' when submitting an application for enrollment.

Response: We have clarified the ``date of filing'' in the provision of the final rule as the date that the Medicare contractor receives a signed provider enrollment application that the Medicare contractor is able to process to approval.

Comment: One commenter recommends that we wait until the Internet- based PECOS system has been released and used by the physician population before making these changes.

Response: As stated above, we do not believe that a change to the effective date of Medicare billing privileges has a nexus to the implementation of the Internet-based PECOS.

Comment: Several commenters recommended that we shorten the period of time during which retrospective billing is permitted from 27 months to 12 months. Another commenter stated that reducing retrospective billing from 27 months to 12 months would provide sufficient time for enrollment to occur, reduce the possibility of improper billing and eliminate the unreasonable administrative burden that the our alternatives would place on all new physicians.

Response: We appreciate these comments, but continue to believe that allowing retrospective billing for 12 months prior to enrollment poses a significant risk to the Medicare program. Accordingly, with the implementation of this final rule, physician and NPPs and physician and

NPP organizations will have a limited time period to submit claims before the effective date of their respective Medicare billing privileges.

Comment: Several commenters urged CMS to establish the new Web- based program and determine the accuracy and ease of the system before making new enrollment rules. This commenter also stated the new Web- based system should be far easier to use than the current process.

Response: We agree with these commenters and, as previously stated, we expect to implement Internet-based PECOS for individuals by the end of CY 2008.

Comment: One commenter stated that they have been advised by

Medicare that this change means upon receiving notice that a graduate nurse anesthetist

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had passed his or her certifying exam that the ``graduate'' now a CRNA can retain any Medicare claims from his or her certification date forward and then submit these held claims upon receiving his or her

National Provider Identifier (NPI). Further, the commenter stated that

Medicare carriers have allowed this payment practice with the understanding that graduate nurse anesthetists are qualified to bill

Medicare for their services upon their certification date.

Response: While we understand this comment, we believe that physicians and NPPs must meet all State licensing requirements before

Medicare can convey billing privileges. Moreover, with the implementation of this final rule, physician and NPPs and physician and

NPP organizations will have a limited time period to submit claims before the effective date of their Medicare billing privileges.

Comment: One commenter stated that they understand that there have been Medicare Carriers that allow CRNAs to hold their claims and back bill for up to 1 year prior to the date they are certified, consistent with Medicare payment policy.

Response: We believe that physician and NPPs must meet all State licensing requirements before Medicare can convey billing privileges.

Moreover, with the implementation of this final rule, physician and

NPPs and physician and NPP organizations will have a limited time period to submit claims before their effective date of Medicare billing privileges.

Comment: One commenter urged CMS to adopt the Council for

Affordable Quality Healthcare's (CAQH) Universal Credentialing Database

(UCD) as its provider credentialing information gathering tool. This commenter stated that CAQH has over 600,000 providers and suppliers in its database and is working with hospitals and State Medicaid programs as well.

Response: While we appreciate this comment, this comment is outside the scope of this final rule. However, it is important to understand that CMS' national enrollment repository, PECOS, maintains Medicare enrollment records on more than 610,000 physicians, 280,000 NPPs, 75,000 single specialty clinics, and 130,000 multi-specialty clinics.

In addition, PECOS maintains enrollment records for all other provider and supplier types, except durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) suppliers. This means that we have collected and retained current enrollment information on approximately 80 percent of physicians and 98 percent of the NPPs enrolled in and billing the Medicare program. In addition, since the information obtained during the enrollment process for physician and NPP organizations updates our claims payment systems for Part B services, we are able to help ensure claims processing accuracy by utilizing its existing processes.

Comment: One commenter urged CMS to produce educational materials beyond the vague tip sheets located at the beginning of each application. In addition, this commenter recommends that we develop a series of frequently asked questions on Medicare provider enrollment.

Response: We already maintain a link to provider enrollment frequently asked questions at http://www.cms.hhs.gov/

MedicareProviderSupEnroll. In addition, this Web site maintains more than 10 different provider enrollment outreach documents that the public can view online or download for future reference.

In an attempt to ensure that all physicians, NPPs, and NPP organizations are aware of and comply with their reporting responsibilities, we developed and posted reporting responsibilities for physicians, NPPs, and physician organizations on our provider enrollment Web page at http://www.cms.hhs.gov/MedicareProviderSupEnroll on September 16, 2008. In addition, on September 17, 2008, we issued a listserv announcement to those individual physicians and NPPs who subscribe to the CMS Physician Open Door Forum and to more than 150 national and State-level organizations that subscribe to the CMS provider partnership network. We also expect that contractors will continue to notify physicians and NPP organizations about their reporting responsibilities by listserv, bulletin, and/or direct mail in

FY 2009 and beyond. With the implementation of this final rule with comment period on January 1, 2009, we will revise the educational materials found on our Web site and distribute this information through our established communication channels. Finally, we will post educational material, including fact sheets and frequent asked questions, regarding Internet-based PECOS as soon as this system is available to the public.

Comment: One commenter asked that we create extensive educational programming on provider enrollment for both our contractors and providers to ensure that both sides thoroughly understand the process and expectations.

Response: We provide Medicare contractors with manual instructions and other directives to ensure consistent enrollment processing. In addition, as stated above, we are disseminating additional educational materials to ensure that the public understands their reporting responsibilities.

Comment: One commenter suggested a process for the Medicare

Contractor to notify the provider that the application has been received and it is being processed to ensure the approved billing date is the same between the provider and the Medicare contractor.

Response: Due to cost constraints, most Medicare contractors can not notify an applicant when their paper enrollment application is received; however, Medicare contractors are required to notify an applicant when the application is missing information or if additional supporting documentation is needed to process the enrollment request.

Comment: One commenter stated that the NPP nomenclature is ambiguous because CMS lists all suppliers as NPPs (including audiologists and physical and occupational therapists) on page 38535 of the proposed rule, rather than limiting this term to physician assistants, nurse practitioners, and clinical nurse specialists as defined in Medicare policy manuals.

Response: We have revised this rule to refer to individual physicians and NPPs and physician and NPP organizations.

Comment: One commenter urges CMS to require contractors to provide accurate and complete information to applicants, allowing their practices to complete their enrollment applications in an easy and efficient manner.

Response: While we appreciate this comment, this comment is outside the scope of this proposed rule and can not be addressed in this final rule.

Comment: One commenter urged CMS to require Medicare contractors to communicate requests for additional information in such a manner that the communications can be easily tracked.

Response: We believe that this issue is outside the scope of the proposed rule and can not be addressed in this final rule.

Comment: One commenter urged a ``timeout'' on the release of new rules and regulations surrounding the Medicare provider enrollment process.

Response: We recognize that we have published several regulations within the last 3 years and a number of program integrity manual instructions designed to strengthen the enrollment process. However, we continue to believe that CMS must maintain the flexibility to issue regulations in accordance with the Administrative Procedures Act.

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Comment: One commenter urged CMS to clarify the apparent inconsistent policies on revalidation as set forth in the April 21, 2006 provider enrollment rule titled, ``Medicare Program: Requirements for Providers and Suppliers to Establish and Maintain Medicare

Enrollment (CMS-6002-F)'' and the June 27, 2008 provider enrollment rule titled, ``Medicare Program: Appeals of CMS or CMS Contractor

Determinations When a Provider or Supplier Fails to Meet the

Requirements for Medicare Billing Privileges (CMS-6003-F).''

Response: In response to comment in the April 21, 2006 final rule

(71 FR 20754), we stated, ``We expect that a fee-for-service contractor would notify the provider or supplier in writing regarding the need to revalidate its enrollment information. Once notified, providers and suppliers would be expected to review, update, and submit any changes and supporting documentation regarding the enrollment record within 60 days. If no changes have occurred, a provider or supplier would simply sign, date, and return the revalidation application.'' In addition, we stated in the provisions of the final rule that, ``We will contact all providers and suppliers directly as to when their 5-year revalidation cycle starts beginning with those providers and suppliers currently enrolled in the Medicare program but that have not submitted a completed enrollment application. The revalidation process would ensure that we collect and maintain complete and current information on all

Medicare providers and suppliers and ensure continued compliance with

Medicare requirements. In addition, this process further ensures that

Medicare beneficiaries are receiving items or services furnished only by legitimate providers and suppliers, and strengthens our ability to protect the Medicare Trust Funds.''

In response to a comment in the June 27, 2008 final rule (73 FR 36448), we stated, ``Therefore, providers and suppliers that enrolled in the Medicare program prior to 2003, but who have not completed a

Medicare enrollment application since then, have had more than 2 years to come into voluntary compliance with our enrollment criteria by submitting a complete enrollment application. With this final rule, we are again notifying physicians, providers, and suppliers that they may voluntarily complete and submit a Medicare enrollment application and the necessary supporting documentation prior to our formal request for revalidation. Accordingly, providers and suppliers who choose not to come into voluntary compliance or fail to respond to a revalidation request in a complete and timely manner fail to satisfy our enrollment criteria and may be subject to revocation of their billing privileges.'' Accordingly, we do not believe that these policies are inconsistent. We continue to encourage all physicians, providers, and suppliers to update their enrollment records when a reportable change occurs, and absent a reportable change we encourage all physicians, providers, and suppliers who have not updated their enrollment record within the last 5 years to do so in advance of contractor's revalidation request. Once we initiate revalidation efforts, physicians and other providers and suppliers will only be provided 60 days to respond to a contractor's request.

Comment: One commenter stated that we should monitor, track, and make publicly available the average length of time from submission of an enrollment application for new procedures to the time the Medicare contractors actually process and notify the providers of acceptance of that enrollment application.

Response: While we monitor contractor provider enrollment processing timeliness using PECOS, we do not currently calculate an average length of time for initial enrollments, changes, and reassignments. We will consider calculating the average length of time for initial enrollment applications, changes of information, and reassignments and making this information available to the public.

Comment: One commenter requests that if we finalize these provisions, a notice of onsite review should be provided 14 days in advance to allow the pharmacy to appropriately schedule for the onsite review.

Response: We disagree with this commenter. We believe that onsite reviews provide CMS and our contractors a valuable tool to ensure that providers and suppliers are in compliance.

Comment: Several commenters remain concerned about the failure of

CMS to permit the use of electronic signatures and electronic documents which would provide practitioners and practices the opportunity to complete and submit the entire application package online.

Response: This comment is outside the scope of this proposed rule and can not be addressed in this final rule.

Comment: One commenter recommended that we hold an open and thorough dialogue with its contractors and the provider community regarding the enrollment process as it currently stands and the problems encountered by all.

Response: We believe that this issue is outside the scope of the proposed rule and can not be addressed in this final rule.

Comment: One commenter stated that they support CMS and the establishment of an electronic enrollment process but they do not believe it will address the provisions in the rule.

Response: While we do not expect that Internet-based PECOS will remedy all provider enrollment processing issues, we do believe that an

Internet-based enrollment process will allow physicians and other providers and suppliers to reduce the time necessary to enroll or make a change in enrollment in the Medicare program.

Comment: One commenter recommended that we establish streamlined and user-friendly procedures that will encourage high rates of physician participation in the Medicare program.

Response: We appreciate this comment and believe that Internet- based PECOS will allow physicians and NPPs the ability to enroll or make changes in their enrollment records faster and more accurately than the paper-based enrollment process.

Comment: One commenter commended CMS for PECOS as it will provide timely ease of use for enrollment as well as updating the enrollment record.

Response: We appreciate this comment.

Comment: One commenter requested that we consider modifying existing provider enrollment applications to include an attestation statement for which an applicant would attest to those certain requisite program requirements having been met prior to the filing of the application.

Response: This recommendation is outside the scope of the proposed rule and can not be addressed in this final rule.

Comment: One commenter stated that we should provide notice 14 days in advance of conducting an onsite review and that reviews on Mondays should be avoided.

Response: This comment is outside the scope of this proposed rule and can not be addressed in this final rule.

Comment: One commenter urged that CMS and the NSC coordinate so that only a single onsite review would be required and the least disruptive to an operation.

Page 69773

Response: This comment is outside the scope of the proposed rule and can not be addressed in this final rule.

After reviewing public comments, we are finalizing the definition of ``physician or nonphysician practitioner (NPP) organization'' at

Sec. 424.502 as ``any physician or NPP organization that enrolls in the Medicare program as a sole proprietorship or any organizational entity.'' Organizational entities include, but are not limited to, limited liability corporations, Subchapter S corporations, partnerships, professional limited liability corporations, professional corporations, and professional associations.

After reviewing public comments, we are finalizing the provision at

Sec. 424.520(d) to state that we will establish an effective date of billing for physicians, NPPs and physician and NPP organizations that would be the later of: (1) The date of filing of a Medicare enrollment application that was subsequently approved by Medicare contractor (that is, carrier, fiscal intermediary or A/B Medicare Administrative

Contractor); or (2) the date a physician, NPP or physician and NPP organization first started furnishing services at its new practice location.

In Sec. 424.521, Request for Payment by Physicians, Nonphysician

Practitioners, Physician or Nonphysician Organizations, we are finalizing the proposals.

In Sec. 424.521(a)(1), we are finalizing a provision that allows physicians, NPPs, physician or NPP organizations to retrospectively bill for services up to 30 days prior to their effective date of billing when the physician or NPP organization met all program requirements, including State licensure requirements, services were furnished at the enrolled practice location prior to the date of filing and circumstances precluded enrollment in advance of providing services to Medicare beneficiaries. Thus, physicians, NPPs, and physician or NPP organizations would be limited to receiving reimbursement for services for a maximum of 30 days prior to filing an enrollment application that was subsequently approved by a Medicare contractor.

In Sec. 424.521(a)(2), we are finalizing a provision that allows a physician, NPP, and physician or NPP organization to retrospectively bill for services up to 90 days prior to their effective date of billing privileges when the physician or NPP organization met all program requirements, including State licensure requirements, services were furnished at the enrolled practice location prior to the date of filing, and a Presidentially-declared disaster under the Robert T.

Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C.

Sec. Sec. 5121-5206 (Stafford Act) precluded enrollment in advance of providing services to Medicare beneficiaries.

While these changes limit the retrospective payments that a physician, NPP, or physician and NPP organization may obtain from the

Medicare program, we believe that this approach will ensure that a

Medicare contractor is able to verify that a physician, NPP or physician and NPP organization meets all program requirements at the time of filing, including State licensure. In addition, this approach will afford Medicare beneficiaries the appropriate protections under the statute, regulations, and CMS policy.

To ensure that eligible physicians, NPPs or physician and NPP organizations receive reimbursement for services furnished, we will require that Medicare contractors deny Medicare billing privileges when a Medicare contractor is not able to process an incomplete enrollment application that is submitted by a physician, NPP or physician and NPP organization. This is a change from our earlier final rule, ``Medicare

Program; Requirements for Providers and Suppliers to Establish and

Maintain Medicare Enrollment,'' (CMS-6002-F) which was published on

April 21, 2006. In this earlier rulemaking effort, we stated that we would reject an incomplete enrollment application. In order to provide physician and NPP organizations and individual practitioners with the opportunity to preserve an initial application filing date, we will deny incomplete applications for these supplier types. We believe that

Sec. 424.530(a)(1) permit a Medicare contractor to deny an incomplete enrollment application.

By denying billing privileges for enrollment in the Medicare program or to establish a new practice location, rather than rejecting an enrollment application, physicians, NPPs or physician and NPP organizations will be afforded appeal rights which will preserve the original date of filing the application. Reimbursement for services furnished back to the effective date of billing will be permitted as long as the applicant submits a corrective action plan or appeal in accordance with Sec. 405.874 and submits the necessary information to cure any application deficiencies. However, if the applicant does not submit a corrective action plan or appeal within the timeframe established in Sec. 405.874, then the applicant would not preserve the right to bill the Medicare program for services furnished from the date of the initial filing of the application or the date the practitioner or organization first started furnishing services at its new practice location.

We are also adopting the ``date of filing'' as the date that the

Medicare contractor receives a signed provider enrollment application that the Medicare contractor is able to process to approval. If the

Medicare contractor denies an enrollment application that is not later overturned during the appeals process, the new date of filing would be established when a physician or NPP organization submits a new enrollment application that the contractor is able to process to approval.

PECOS is the system that supports the Medicare provider and supplier enrollment process by collecting and storing provider and supplier information obtained from the Medicare enrollment application

(that is, the CMS-855). The PECOS database retains enrollment information on Part A providers that bill fiscal intermediaries (FIs) or A/B Medicare Administrative Contractors (A/B MAC) and Part B providers, including physicians and NPPs that bill carriers or A/B

MACs.

Medicare contractors use PECOS to establish new enrollment records for providers and suppliers, update provider and supplier information, and process requests from individual health care practitioners for assignment of benefits. PECOS standardized the Medicare enrollment process and supplies enrollment data to the Part A and Part B claims processing systems.

In June 2002 and November 2003, we implemented PECOS for fiscal intermediaries (FIs) and carriers respectively. Today, PECOS is used by carriers, FIs, and A/B MACs to enter data submitted on the Medicare enrollment application. However, by establishing an Internet-based enrollment process, we will allow providers and suppliers (except suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS)) suppliers, the option of enrolling or making a change in their Medicare enrollment information via the Internet.

Internet-based PECOS will allow Medicare providers and suppliers to enroll or make a change in their Medicare enrollment record. The primary objectives for the Web enablement of PECOS are to: (1) Reduce the time necessary for providers and suppliers to enroll or make a change in their Medicare information; (2) streamline the enrollment process for providers and suppliers; (3) allow

Page 69774

physicians and NPPs to manage their enrollment information and verify their reassignments of benefits; and (4) reduce the administrative burden associated with completing and submitting enrollment information to Medicare.

Additional information regarding Internet-based PECOS will be made available later this year. This information will be posted on the

Medicare provider/supplier enrollment Web site at http:// www.cms.hhs.gov/MedicareProviderSupEnroll.

With the implementation of an Internet enrollment process referred to as the Internet-based PECOS, the date of filing for individual practitioners submitted through Internet-based PECOS is the date the

Medicare contractor receives both: (1) An electronic version of the enrollment application; and (2) a signature page containing an original signature that the Medicare contractor processes to approval. The date of filing for organizational entities submitted through Internet-based

PECOS is the date the Medicare contractor receives all of the following: (1) An electronic version of the enrollment application; (2) a signature page containing an original signature that the Medicare contractor processes to approval.

To address public concerns regarding the burden and complexity associated with the Medicare enrollment process, we will implement

Internet-based PECOS in three distinct phases. We will implement

Internet-based PECOS for all individual physicians and NPPs enrolling or making a change to an existing enrollment record in Phase I. In

Phase II, we will implement Internet-based PECOS for all organizational providers and suppliers, except DMEPOS suppliers, enrolling or making a change to an existing enrollment record. In Phase III, we will implement Internet-based PECOS for DMEPOS suppliers.

Based on current operating assumptions, we expect to begin implementation of Phase I by the end of CY 2008, with full implementation scheduled for completion in January 2009. We also expect to make Internet-based PECOS available to physicians and NPPs in all

States, including California, Missouri, and New York.

Phase II is tentatively scheduled for implementation beginning in

Spring 2009, with full implementation scheduled for completion by June 30, 2009. Phase III is tentatively scheduled for implementation in CY 2010.

Since Internet-based PECOS is a scenario-driven application process with front-end editing capabilities and built-in help screens, we believe that this new enrollment application process will significantly simplify and streamline the enrollment process for physicians, providers and suppliers, reduce the time necessary to enroll or make a change to a Medicare enrollment record, reduce the administrative burden associated with completing and submitting enrollment information to Medicare, decrease the errors during the application submission process, and allow physicians and NPPs to take personal responsibility for their Medicare enrollment in a timely manner. Moreover, unlike the paper-based enrollment process, Internet-based PECOS' scenario-driven application process will ensure that prospective providers and suppliers or enrolled providers and suppliers only complete and submit the information necessary to apply or make a change in their Medicare enrollment record. Physicians and NPPs will no longer see questions that are not applicable for their supplier-type.

While we will encourage all physicians, NPPs, physicians and NPP organizations and other providers and suppliers to utilize Internet- based PECOS when it is made available for their provider/supplier type and their State, all providers and suppliers will continue to have the option of submitting an enrollment application by paper.

In order to use Internet-based PECOS to enroll or make a change in an enrollment record, physicians and NPPs will be required to use the

User ID and user password obtained when applying for or updating their

National Provider Identifier (NPI) with the National Plan and Provider

Enumeration System (NPPES). Accordingly, physicians and NPPs will need to know their NPPES User ID/password information before trying to enroll or change their enrollment record with Medicare via Internet- based PECOS. To ensure privacy and security for these individual practitioners, we encourage that physicians and NPPs to reset their user password prior to initiating their first enrollment action via

Internet-based PECOS, reset their user password at least once a year thereafter, and that physicians and NPPs not share their NPPES User ID/ password with billing agents, clearinghouses, academic medical institutions, or staff within their practice.

Physicians and NPPs choosing to use billing agents, clearinghouses, academic medical institutions, etc. will be required to submit a paper enrollment application to enroll or make a change in their Medicare enrollment record.

In order to use Internet-based PECOS to enroll or make a change in an organizational enrollment record, we will verify that the authorized official associated with the Medicare enrollment record is employed by the organization and is authorized by the organization to submit or make changes to the organization enrollment record.

Over the last 2 years, we have stressed the importance of filing a complete application at the time of filing or in response to a contractor's request for additional information. However, Medicare contractors continue to report that a significant number of applications are incomplete at the time of filing or that applicants do not respond timely and completely to a contractor's request for additional information.

Finally, in the April 21, 2006 final rule, physicians, NPPs, and physician and NPP organizations learned about our intent to begin a revalidation process.

Specifically, Sec. 424.515 states that a provider or supplier

(other than a DMEPOS supplier), must resubmit and recertify the accuracy of its enrollment information every 5 years. Therefore, physicians, NPPs and physician and NPP organizations that enrolled in the Medicare program prior to 2003, but who have not completed a

Medicare enrollment application since then, have had more than 2 years to come into voluntary compliance with our enrollment criteria by submitting a complete enrollment application. To date, approximately 80 percent of the enrolled physicians and 98 percent of NPPs have updated their Medicare enrollment record within the last 5 years.

To ensure that Medicare only pays eligible physicians and NPPs, we are again notifying physicians and NPPs that they may voluntarily complete and submit a Medicare enrollment application and the necessary supporting documentation prior to our formal request for revalidation.

In accordance with the existing provision at Sec. 424.535(a)(1)(ii), providers and suppliers who choose not to come into voluntary compliance or fail to respond to a revalidation request within 60 days of the Medicare contractor's request may be subject to the revocation of their billing privileges. 2. Medicare Billing Privileges and Existing Tax Delinquency

The Government Accountability Office (GAO) found that over 21,000 of the physicians, health professionals, and suppliers paid under

Medicare Part B during the first 9 months of CY 2005 had tax debts totaling over $1 billion.

Continued on page 69775

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

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pp. 69775-69824

Medicare Program; Payment Policies Under the Physician Fee

Schedule and Other Revisions to Part B for CY 2009; E-Prescribing

Exemption for Computer-Generated Facsimile Transmissions; and Payment for Certain Durable Medical Equipment, Prosthetics, Orthotics, and[Page 69775]

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The GAO report titled, ``Medicare, Thousands of Medicare Part B

Providers Abuse the Federal Tax System (GAO-07-587T)'' found abusive and potentially criminal activity, including failure to remit to IRS individual income taxes or payroll taxes or both withheld from their employees.

While we do not currently consider whether an individual physician,

NPP currently enrolled in the Medicare program has delinquent tax debts with the Internal Revenue Service (IRS), we do consider whether a physician or NPP was convicted of a Federal or State felony offense, including income tax evasion, that we have determined to be detrimental to the best interest of the Medicare program. Moreover, if a physician or NPP was convicted of Federal or State felony offense within the 10 years preceding enrollment or revalidation of enrollment that we determined to be detrimental to the best interest of the Medicare program, we could deny or revoke the Medicare billing privileges of the physician or NPP.

The Financial Management Service (FMS), a bureau of the Department of Treasury, initiated the Federal Payment Levy Program (FPLP) portion of the Continuous Levy Program in July 2000 to recover delinquent

Federal tax debts. The FPLP is a program whereby delinquent Federal income tax debts are collected by levying non-tax payments, as authorized by the Taxpayer Relief Act of 1997 (Pub. L. 105-34). The

FPLP includes vendor and Social Security benefit payments, and Medicare payments. It is accomplished through a process of matching delinquent debtor data with payment record data. This automated collection of debt at the time of payment occurs after the delinquent taxpayer has been afforded due process, in accordance with the Internal Revenue Code.

In July 2000, the IRS in conjunction with the Department of

Treasury's FMS started the FPLP which is authorized by section 6331(h) of the Internal Revenue Code as prescribed by section 1024 of the

Taxpayer Relief Act of 1997. Through this program, the IRS can collect overdue taxes through a continuous levy on certain Federal payments disbursed by FMS; it generally allows Medicare to match a claim to a delinquent taxpayer, offset the payment, and recover a percentage of the amount due.

The FPLP is a collection and enforcement tool used by the IRS for individuals that have received all requisite notification of tax delinquency and who have either exhausted or neglected to use their respective appeal rights; therefore, the FPLP is only applied after all previous IRS collections efforts have failed. Accordingly, the FPLP is an automated levy program where certain delinquent taxpayers are systematically matched and levied on their Federal payments disbursed by Treasury's FMS.

In 2001, we implemented the FPLP process for Medicare Part C and vendor payments, and in FY 2009, we will implement the FPLP process for payments made to providers and suppliers reimbursed under Part A and

Part B of the Medicare program. However, the FPLP does not allow CMS to offset a payment when an individual reassigns his or her benefits to a third-party, such as a group practice where an existing Federal tax delinquency exists.

Consistent with statutory authority found under sections 1866(j)(1)(A) and 1871 of the Act, we believe that we have the authority to establish and make changes to the enrollment process for providers and suppliers of service. Accordingly, to ensure that the

Federal government is able to recoup delinquent Federal tax debts from physicians and NPPs who are enrolled in the Medicare program and are receiving payments, we are considering revoking the billing privileges for those individuals for whom a tax delinquency exists and we are unable to directly levy future payments through the FPLP. While we did not propose this change in this year's PFS proposed rule, we will consider proposing this type of change in a future rulemaking effort after we have implemented the FPLP process, monitored and evaluated the implementation of FPLP process, and analyzed the potential impact of this change on physician and NPPs who are subject to the FPLP but for whom we are unable to directly levy future payments through the FPLP.

In addition, we expect to conduct outreach regarding our implementation of the FPLP in FY 2009.

We believe that this change, if proposed and adopted, would prohibit an individual with a tax delinquency from shielding their future payments through reassignment of benefits to a third party.

Finally, since the tax delinquency would be incurred by an individual who has reassigned his or her benefits to a third party, we do not believe that it is appropriate to take action against the third-party.

We believe that this is consistent with the protections already afforded to an individual by the IRS but ensures that Medicare does not enroll or allow continued enrollment to an individual with a serious tax delinquency.

We maintain that it is essential that a physician or NPP resolve any existing Federal tax delinquency before entering the Medicare program. This will ensure that the Medicare program is not making payments to an individual who has not met his or her obligation to pay their tax debts.

Finally, we solicited comments on whether we should consider revoking a physician's billing privileges or taking some other type of administrative action when a physician or NPP has a Federal tax delinquency that can not be levied through the FPLP process. We also solicited comments on whether we should consider revoking the billing privileges of an organizational entity or taking some other type of administrative action against organizational entities when the owners of an organizational entity have a Federal tax delinquency that can not be levied through the FPLP process.

Comment: One commenter recommends an alternative to payment denial where an individual with a tax delinquency has reassigned their benefits to a group. The commenter suggested that the government garnish a portion of the individual practitioner's salary directly, as appropriate. Another commenter does not believe it is appropriate to penalize all of the partners in a practice, when only one individual is guilty of tax evasion. One commenter requests that we define, in greater detail, the term ``reliable information,'' and also that we assure some formal type of appeals process apart from a simple rebuttal. Another commenter questions if there is a mechanism in place whereby a potential new hire can be held harmless should his or her potential employer find itself in a delinquent status within a 12-month period. One commenter questions whether the burden of reporting an adverse legal action would be placed upon the individual saddled with the action rather than his or her group managing partners, for sometimes the principals are not aware of the actions of their employees. Another commenter stated that at a minimum, the third party involved should be sent notification of the provider's revoked billing privileges 18 months before the date of revocation. One commenter believes that this provision is not logistically possible because it raises too many issues, including taxpayer privacy, equal opportunity employment concerns, and perhaps even whistleblower triggers regarding noncompliance.

Response: Section 189 of the MIPPA requires that CMS take all necessary steps to participate in the Federal

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Payment Levy Program (FPLP) under section 6331(h) of the Internal

Revenue Code of 1986. The FPLP process allows CMS to levy current and future payments until the tax delinquency is eliminated.

After reviewing comments received in response to our solicitation for comments regarding whether we should consider revoking billing privileges or taking some other administrative action when a physician or NPP has a Federal tax delinquency that cannot be levied through the

FPLP process, we are considering whether future rulemaking or administrative action is needed in this area. We appreciate the public insight regarding our solicitation for comments and will consider these comments in developing any future rulemaking proposals; however, we continue to maintain that physicians and NPPs should resolve any existing Federal tax delinquency before enrolling in the Medicare program or as soon as practical if the physician is enrolled in

Medicare. 3. Denial of Enrollment in the Medicare Program (proposed Sec. 424.530(a)(6) and (a)(7))

Currently, owners, authorized officials, and delegated officials of physician and NPP organizations and individual practitioners, including physicians and NPPs, can obtain additional billing privileges by establishing a new tax identification number (TIN), reassigning benefits to another entity, or by submitting an enrollment application as another provider or supplier type even though the entity for which the provider or supplier furnished services and has had its billing privileges revoked, suspended, or has an outstanding Medicare overpayment. Absent a reason to reject or deny a Medicare enrollment application, the Medicare FFS contractor is required to approve the enrollment application for a provider or supplier who meets all other

Federal and State enrollment requirements for their provider or supplier type.

By submitting and having an enrollment application (for example, an initial application or a change of ownership) with a new TIN, some physician and NPP organizations and individual practitioners are able to circumvent existing Medicare revocation, payment suspension, overpayment recovery, and medical review processes by obtaining additional Medicare billing privileges. By obtaining additional billing privileges for multiple locations, these providers and suppliers are able to discontinue the use of the NPI that has an administrative action against it and bill and receive payment under another NPI.

Consistent with existing Sec. 405.371, we will impose a payment suspension when we possess reliable information that an overpayment or fraud, or willful misrepresentation exists, or that payments to be made may not be correct. Suspension procedures give providers and suppliers an opportunity to submit a rebuttal to CMS' payment suspension determination. We believe that it is essential that we resolve the payment suspension determination before we grant additional billing privileges to these providers or suppliers. In concert with Sec. 405.372(c), once a payment suspension has been terminated, providers and suppliers may then apply for billing privileges.

Moreover, we are obligated to recover Medicare overpayments as expeditiously as possible. Providers and suppliers can pay the debt or

Medicare can reduce present or future Medicare payments and apply the amount withheld to the indebtedness. When we identify an overpayment and provide notice of the overpayment, physician and NPP organizations and individual practitioners are given an opportunity to appeal the determination. Under certain conditions, the overpayment collection process is suspended during the appeals process. However, if the physician and NPP organization or individual practitioner does not appeal the overpayment determination, or if the overpayment determination is upheld on appeal, we will initiate a recovery action.

Accordingly, we proposed to add a new Sec. 424.530(a)(6) and

(a)(7) to deny enrollment applications for additional Medicare billing privileges if the physician or NPP organization or individual practitioner has an active payment suspension or has an existing overpayment that has not been repaid. We proposed to allow a Medicare

FFS contractor to deny enrollment applications from those authorized officials, delegated officials, owners, and individual practitioners that own a supplier or provider at the time of filing until such time as the suspension has been terminated or the Medicare overpayment has been repaid in full. Specifically, we proposed to deny enrollment to any current owner (as defined in Sec. 424.502), physician, or NPP, who is participating in the Medicare program and is under a current

Medicare payment suspension.

We stated that we believe that the change to our denial policy would help protect the Medicare program from unscrupulous or problematic physician and NPP organizations and individual practitioners. Moreover, we believe this change would: (1) Allow

Medicare FFS contractors to improve customer service to all providers and suppliers that are already enrolled in the Medicare program; (2) facilitate the enrollment of all providers and suppliers seeking to enroll in the Medicare program for the first time; and (3) expand on existing efforts to process changes in a timely manner and provide better customer service.

Comment: Several commenters stated that our proposal to deny additional billing privileges to a physician or an NPP when the physician or NPP is suspended or has an outstanding overpayment is a denial of due process and is in conflict with the principle of innocent until proven guilty.

Response: We believe that we have an obligation to protect the

Medicare program from inappropriate payments. Conversely, physicians and NPPs have an obligation to the Medicare program to resolve payment suspensions and overpayment actions in a timely manner. Finally, as a payer of health care, we believe that additional billing privileges should not be conveyed to a physician, NPP or owners, authorized and delegated officials who have an existing payment suspension or overpayment. To grant additional billing privileges to individuals with an existing payment suspension or overpayment exposes the Medicare

Trust Funds to additional risks.

With Medicare's implementation of the NPI on May 23, 2008, Medicare contractors no longer issue billing numbers to providers and suppliers participating in the Medicare program. However, Medicare contractors do convey billing privileges to providers and suppliers that have an NPI and meet all of the program requirements for their provider or supplier type. Once enrolled, providers and suppliers are required to use their

NPI to submit claims to Medicare, and based on the NPI final rule, organizations may obtain one or more NPIs.

After reviewing public comments, we are finalizing the provisions at Sec. 424.530(a)(6) and (a)(7) to deny enrollment applications for additional Medicare billing privileges if a physician, NPP, physician or NPP organization has an existing payment suspension or has an existing overpayment that has not been repaid. We believe that permitting a Medicare contractor to deny enrollment applications submitted by individual practitioners, authorized officials, delegated officials, and owners until such time as the Medicare overpayment

Page 69777

has been repaid in full will require providers and suppliers to resolve overpayments in a timely manner. Once CMS has imposed a payment suspension, a provider or supplier may submit a rebuttal to CMS for the purpose of reducing or terminating the payment suspension. As long as the payment suspension is effective, the contractor has the task of making an overpayment determination. Specifically, we are adopting the provision to deny enrollment to any physician, or NPP current owner (as defined in Sec. 424.502), authorized or delegated official who is participating in the Medicare program and is under an existing Medicare payment suspension or has an outstanding overpayment that has not been repaid in full. As adopted, physicians and NPPs will not be allowed to enroll and reassigning payments to a third-party if the individual practitioner has an existing payment suspension or overpayment that have not been repaid. 4. Reporting Requirements for Providers and Suppliers (Sec. 424.516 and Sec. 424.535(a)(10))

Currently, Sec. 424.520(b) requires that providers and suppliers, except DMEPOS and IDTF suppliers, report to CMS most changes to the information furnished on the enrollment application and furnish supporting documentation within 90 calendar days of the change (changes in ownership must be reported within 30 days). As specified in Sec. 424.57(c)(2), DMEPOS suppliers have only 30 calendar days to submit changes of information to CMS. As specified in Sec. 410.33(g)(2),

IDTFs, must report changes in ownership, changes in location, changes in general supervision, and final adverse actions within 30 calendar days. All other changes to the enrollment application must be reported within 90 days.

While physician and NPP organizations and individual practitioners are required to report changes within 90 days of the reportable event, in many cases, there is little or no incentive for them to report a change that may adversely affect their ability to continue to receive

Medicare payments. For example, physician and NPP organizations and individual practitioners purposely may fail to report a felony conviction as described in Sec. 424.535(a)(3), or other final adverse action, such as a revocation or suspension of a license to a provider of health care by any State licensing authority, or a revocation or suspension of accreditation, because reporting this action may result in the revocation of their Medicare billing privileges. Thus, unless

CMS or our designated contractor becomes aware of the conviction or final adverse action through other means, the change may never be reported by a physician and NPP organization or individual practitioner. Alternatively, if CMS or our designated contractor becomes aware of the conviction or final adverse action after the fact, we have lacked the regulatory authority to collect overpayments for the period in which the physician and NPP organizations and individual practitioners should have had their billing privileges revoked.

Since we believe that physician and NPP organizations and individual practitioners must furnish updates to their Medicare enrollment information in a timely manner, we are adopting a new Sec. 424.516(d) which would establish more stringent reporting requirements for physician NPP organizations and individual practitioners. (We proposed to redesignate Sec. 424.520 as Sec. 424.516 and amend the provisions in new Sec. 424.516.) In addition to a change of ownership

(as currently specified in redesignated Sec. 424.516(d)(1)(i)), we proposed to add Sec. 424.516(d)(1)(ii) requiring all physician and NPP organizations and individual practitioners to notify our designated contractor of any final adverse action within 30 days. We stated that final adverse actions include, but are not limited to, felonies, license suspensions, and the HHS Office of the Inspector General (OIG) exclusion or debarment. We believe that a physician and NPP organizations and individual practitioner's failure to comply with the reporting requirements within the time frames described above may result in the revocation of Medicare billing privileges and a Medicare overpayment from the date of the reportable change. Specifically, we believe that a final adverse action may preclude payment, and thus, establish an overpayment from the date of the adverse action. As such, we believe that physician and NPP organizations and individual practitioners should not be allowed to retain any reimbursement they receive after the final adverse action.

In addition, we added the word ``final'' to the beginning of the term ``adverse legal action'' in the regulation text in Sec. 424.535 on overpayment. We define the term as a ``final adverse action'' in the definition section at Sec. 424.502 and want to be consistent with that definition. Also, we want to be consistent with our definition of this term in the Durable medical Equipment prosthetics Orthotics and

Supplies surety bond rule (CMS-6006-F). Moreover, we want this term to be consistent with the definition of ``final adverse action'' found in section 221(g)(1)(A) of the Health Insurance Portability and

Accountability Act (HIPAA) of 1996. Finally, we believe that a final adverse action has occurred when the sanction is imposed and not when a supplier has exhausted all of the appeal rights associated with the action itself.

We believe that it is essential that this type of change be reported in a timely manner (that is within 30 days). For example, if

CMS or our designated contractor determines in February 2008 that a physician failed to notify Medicare about a final adverse action that occurred on June 30, 2007, that physician may be subject to an overpayment for all Medicare payments beginning June 30, 2007 and have their Medicare billing privileges revoked effective retroactively back to June 30, 2007 as well.

Additionally, we proposed to add a requirement for change in location at Sec. 424.516(d)(1)(iii). Since a change in location may impact the amount of payment for services furnished by placing the physician and NPP organizations and individual practitioners into a new

Core Based Statistical Area (CBSA). We believe that it is essential that physician and NPP organizations and individual practitioners report changes in practice location including those that impact the amount of payments they receive within a timely period (that is, 30 days). However, unlike a final adverse action, which may preclude all payments if reported, failure to report a change in practice location may impact the amount of payment, not whether a physician and NPP organizations and individual practitioners may be eligible to receive payments. Accordingly, we believe that failing to report changes in practice location would result in an overpayment for the difference in payment rates retroactive to the date the change in practice location occurred and may result in the revocation of Medicare billing privileges. For example, if a physician and NPP organization moves its practice location in New York, from urban Herkimer County to Hamilton

County or Lewis County, which are both rural, but fails to update its provider enrollment information; then it would no longer be able to receive the higher payment rate associated with Herkimer County. We believe that reporting these types of changes is essential for making correct and appropriate payments.

We proposed to add Sec. 424.535(a)(9) which would specify that failure to comply with the reporting requirements

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specified in Sec. 424.516(d) would be a basis for revocation.

Additionally, we proposed in Sec. 424.565, ``Failure to comply with the reporting requirements specified in Sec. 424.516(d) would result in a Medicare overpayment from the date of a final adverse action or a change in practice location.'' In this situation, an overpayment for failure to timely report these changes would be calculated back to the date of the final adverse action or the date of the change in practice location. Once an overpayment has been assessed, we will follow the overpayment regulations established at 42 CFR part 405 subpart C. We previously addressed these procedures in Chapter 4 of the Medicare

Financial Management Manual (IOM Manual 100-06). Lastly, collection of overpayments related to Sec. 424.516(d)(1)(iii) would not begin until after the effective date of the final rule.

Since it is essential that physician and NPP organizations and individual practitioners notify their designated contractor of these types of reportable events in a timely manner and to ensure that the provider or supplier continues to be eligible for payment, we believe that it is essential that we establish an overpayment from the time of the reportable event. We believe that establishing an overpayment and revocation of billing privileges for noncompliance from the time of the reportable event would provide the supplier with a compelling incentive to report reportable changes in the 30-day reporting period.

In addition, if CMS or our designated contractor determines that a physician and NPP organization or an individual practitioner has moved and has not reported the reportable event within the 30-day reporting period, CMS or our designated contractor would impose an overpayment, if applicable, and revoke billing privileges for a period of not less than 1 year.

Comment: One commenter would like to laud CMS for expounding on reporting requirements for the updates regarding address changes, as well as reporting an adverse legal action in a manner to be complete within 30 days. The commenter continued to state that failure to report changes in location, leading to potential overpayment, and revocation of Medicare billing privileges needs to be highlighted for all providers.

Response: We appreciate this comment and will consider expanding this provision to all providers and suppliers in a future rulemaking effort.

Comment: One commenter stated that it disagrees with our assumption that all payments subsequent to an adverse legal action are collectable overpayments.

Response: Since final adverse actions such as Federal exclusion or debarment, felony convictions as described in Sec. 424.535(a)(3) or license suspension or revocation that precluded continued enrollment in the Medicare program.

Comment: One commenter stated that while a CMS representative publicly stated that the proposed rule should have referenced adverse legal actions that have been finally adjudicated, the commenter recommends that CMS clarify this language in the final rule. Several commenters recommended that only adverse legal actions that are relevant to the practice of medicine should be required to be reported to CMS.

Response: Based on these comments, we are adding a definition of a final adverse action to Sec. 424.502(a). Specifically, we have defined a final adverse action to mean one or more of the following actions:

(1) A Medicare-imposed revocation of any Medicare billing privileges;

(2) Suspension or revocation of a license to provide health care by any

State licensing authority; (3) Revocation or suspension by an accreditation organization; (4) A conviction of a Federal or State felony offense (as defined in Sec. 424.535(a)(3)(i)) within the last 10 years preceding enrollment, revalidation, or re-enrollment; or (5)

An exclusion or debarment from participation in a Federal or State health care program.

Comment: One commenter suggested that we should clarify in the final rule that with regard to adverse legal actions, the requirements should apply only to notification within 30 days of ``final'' legal actions that are relevant to or otherwise impact the practice of medicine.

Response: While we understand that physicians and NPPs are afforded different appeal rights depending on the type of final adverse action, we do not believe that it is appropriate to allow physicians and NPPs to continue to furnish services to Medicare beneficiaries if their

State medical license has been suspended or revoked, a Federal exclusion or debarment or Medicare revocation has been imposed, or the physician or NPP was found guilty or pled to felony conviction as described in Sec. 424.535(a)(3).

Comment: One commenter believes that if CMS wants to collect alleged overpayments for services paid during the 90 days as if they were performed in a higher-paying locale, then they should also pay the difference for underpayments when a physician provides services for up to 90 days in a higher paying locality prior to notifying CMS of the change in location.

Response: We maintain that it is the responsibility of the physician, NPP or physician or NPP organization to update their enrollment information within the appropriate timeframes. Further, note that CMS will not reprocess claims for the services provided when there has been a failure to report a change in practice location.

Comment: Several commenters stated that a State licensing board is the proper authority to weigh the significance of legal actions against a physician. Another commenter stated that State licensing and other requirements already protect beneficiaries from the most important kinds of issues that could arise in medical care.

Response: While we agree that State licensing boards are responsible for determining whether an individual meets or continues to meet the qualifications for a specific State medical license, we do not agree that a State license is the only criteria that an individual must maintain in order to receive billing privileges from the Medicare program.

Comment: One commenter stated that they do not oppose changing the time period for reporting adverse legal actions from 90 days to 30 days, as generally payments should not be made under these circumstances.

Response: We appreciate this comment.

Comment: One commenter stated that they did not agree that a change in practice location should be treated as an urgent matter that would support a retroactive revocation of billing authority.

Response: We disagree with this commenter. Since physicians and

NPPs receive payments in part on locality adjustments based on the place of service, we believe that physicians, NPPs, and physician and

NPP organizations are responsible for updating their enrollment record within 30 days of a change in practice location. It is also important to note that we already have existing authority to revoke the billing privileges of a Part B supplier, including physicians and NPPs, if CMS or our contractor determines that upon an on-site review or other reliable evidence that the supplier is not operational (see Sec. 424.535(b)(5)).

Comment: One commenter stated that they oppose changing the time period for reporting a change in location from 90 days to 30 days because the physician is still eligible for payment and Medicare's vulnerability to overpayments is limited.

Response: While we agree that a physician may still be eligible to receive

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payment, the issue in question is the amount of payment. Moreover, as a payer of health care, we believe that physicians and all other providers and suppliers have a responsibility to update their enrollment record when a change in practice location occurs. This will allow CMS or our contractor to verify that services are actually furnished at the practice locations identified by the medical practices.

Comment: One commenter stated that if we finalize our reporting requirements, a better option would be to limit the types of actions that are reportable to similar actions that are required to be reported to the National Practitioner Data Bank (NPDB) which was established by the Congress to address the need to improve the quality of medical care by encouraging State licensing boards, health care entities such as hospitals, and professional societies to identify and discipline those who engage in unprofessional behavior, as well as restrict a practitioner's ability to move from State to State without disclosure of previous adverse action history.

Response: We disagree with this commenter. In considering the types of events that should be reported within 30 days of the reportable event, with this final rule with comment period, we have limited the types of reportable events to three specific types of events: (1)

Change in ownership, (2) final adverse actions, and (3) change in practice location. We believe that the failure to report any of these types of reportable events may result in payments to the wrong organization, erroneous payments if the physician or NPP payment no longer meets State licensure requirements, or payments in the wrong amount when a change in practice location impacts the payment to a physician, NPP or physician or NPP organization.

Comment: One commenter stated that our proposal to revoke billing privileges for a period of not less than 1 year for failure to comply with the proposed 30-day reporting period is a harsh and unjust penalty for a minor paperwork offense.

Response: While we understand this commenter's concern, we believe that physicians, NPPs, physician and NPP organizations have an obligation to report certain changes, including State license suspensions and revocations, felony convictions as described in Sec. 424.535(a)(3), Federal debarments and exclusions, within 30 days since these adverse actions may affect a physician, NPP or physician or NPP organization's ability to continue to participate in the Medicare program.

Comment: One commenter urged CMS to consider that the failure to notify Medicare contractors of a change in location is an oversight rather than a true attempt to defraud the Medicare program.

Response: Since physicians, NPPs, and physician and NPP organizations routinely notify State medical societies, vendors, employees, utility companies, leasing companies, and others prior to a change in practice location, we disagree with this commenter that change in location is an oversight.

Comment: One commenter stated that that while there is a need to maintain timely provider records and track Medicare payments, proposed penalties for failure to report an address change promptly are so out of proportion to the offense as to be draconian.

Response: We disagree with this commenter. As stated above, we understand that physicians, NPPs, and physician and NPP organizations routinely notify other payers and affiliated business partners about a change of practice location in advance of the change. In addition, to ensure payment accuracy, it is essential that physicians, NPPs, and physician and NPP organizations report changes in practice locations prior to change, but not later than 30 days after the reportable event.

Comment: One commenter stated that it seemed sufficient to collect any overpayment from providers that file their change of address notice within the traditional 90-day window for updating enrollment records.

Response: As a payer of health care, it is essential that we make every attempt to make correct payments for services furnished by qualified providers and suppliers. To help ensure that we are making the correct payments the first time, we believe that it is necessary that physicians, NPPs, and physician and NPP organizations update their enrollment records when a change in practice location occurs.

Comment: One commenter urges CMS to withdraw the proposal to establish authority to require that physicians report a change in ownership, ``any'' adverse legal action, or change in practice location within 30 days since these events may be unrelated to the Medicare program and the reporting time frame is unduly burdensome to physicians.

Response: We disagree with this commenter. Since June 20, 2006, physicians and NPP organizations have been required to report a change in ownership within 30 days and changes in practice locations and final adverse actions within 90 days (see Sec. 424.516(d)). Since we are aware of situations where physicians and NPPs have not reported State license suspensions/revocations or final adverse actions which may affect a physician or NPPs eligibility to participate in the Medicare program, we believe that it is essential to establish more stringent reporting requirements than in the past. We believe that these requirements along with corresponding enforcement procedures will encourage physicians, NPPs and physician and NPP organizations to report changes in ownership, final adverse actions, and changes in practice location in a timely manner (that is, 30 days.)

Comment: One commenter stated that ``any adverse legal action'' is not defined; therefore a 30-day reporting requirement is unreasonable as are the other proposed requirements. The commenter also stated that we should save our severe penalties for proven fraudulent behavior, not minor clerical oversights.

Response: We disagree with this commenter that failure to report a final adverse action is a minor clerical oversight. Since reporting a final adverse action may affect a physician or NPP's ability to continue to participate in the Medicare program, we understand why these actions may not be reported to a Medicare contractor; however, we believe that final adverse actions, including State licensing suspensions and revocations, should be reported within 30 days of the reportable event, even if the physician or NPP plans on appealing the final adverse action. By reporting the final adverse action within 30 days, the Medicare program will carefully review any revocation action and exercise its discretion as to whether to impose a revocation and the length of time of the reenrollment bar.

Comment: One commenter stated that a revocation of billing privileges seems to be a disproportionately severe penalty for infractions such as: (1) Failure to report changes in ownership, adverse legal actions, and changes in practice location, or (2) not maintaining ordering and referring documentation for a 10-year period.

Response: We disagree with this commenter. As stated above, we believe reporting changes in ownership, final adverse actions, and changes in practice locations are essential to ensuring that the

Medicare program makes correct payments to eligible practitioners and organizations. We also believe that it is essential that physicians and

NPPs maintain ordering and referring documentation to support the claims submissions.

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Comment: One commenter stated that levying an overpayment for failure to report a ``reportable event,'' within 30 days is excessive for what is likely an honest oversight.

Response: We disagree with this commenter that establishing an overpayment is excessive when a physician, NPP or physician and NPP organization fails to report a final adverse action, such as a State license suspension or revocation or adverse legal action, that may preclude participation in the continued participation in the Medicare program in a timely manner (that is, 30 days).

Comment: One commenter stated that Federal regulations regarding overpayments are already established at 42 CFR part 405, therefore, changing the provider enrollment requirements to prevent overpayments is not necessary.

Response: We disagree with this commenter because the existing overpayment regulations do not allow us to assess an overpayment based on the failure of a physician, NPP, or physician or NPP organizations to report certain reportable enrollment events.

Comment: One commenter stated that they were concerned over inconsistency in the verbiage of this section where we state in the CY 2009 PFS proposed rule (73 FR 38538 through 38539) that billing privileges may be revoked in one place and in the other place state that they would be revoked.

Response: We appreciate this comment and have clarified in this final rule to use the word, ``may'' when referring to the revocation of

Medicare billing privileges.

Comment: One commenter recommends that a 60-day limit be imposed rather than the proposed 30 days for notifying CMS about a ``reportable event.''

Response: We believe that changes of ownership, adverse legal actions, and changes in practice locations can and should be reported within 30 days of the reportable event. By reporting these types of reportable events within 30 days, the Medicare program can take the necessary steps to ensure that we are paying physicians and NPPs correctly and ensure that only eligible physicians and NPPs are enrolled in the Medicare program.

After reviewing public comments, we are finalizing the provision at proposed Sec. 424.516(d) which would require physicians, NPPs or physician and NPP organizations to notify its Medicare contractor of a change of ownership, change in practice location or any final adverse action within 30 days of the reportable event. In addition, we believe that physician and NPP organizations' and individual practitioners' failure to comply with the reporting requirements within the time frame described above may result in the revocation of Medicare billing privileges and the imposition of a Medicare overpayment from the date of the reportable change. Specifically, we believe that a final adverse action may preclude payment, and thus, establish an overpayment from the date of the adverse legal action. As such, we believe that physician and NPP organizations and individual practitioners should not be allowed to retain any reimbursement they receive after the date of the adverse legal action. In addition, physicians, NPPs, or physician and NPP organizations who voluntarily report a final adverse action that prohibits further payment will have their Medicare billing privileges revoked and have an overpayment assessed back to the date of the reportable event. CMS has the discretion to revoke the supplier's billing privileges. Moreover, revocation affords the supplier appeal rights and by reporting an adverse legal action within 30 days of the reportable event, a physician or NPP or physician or NPP organization may regain billing privileges if the final adverse action no longer impedes the applicant's reenrollment into the Medicare program.

We are also finalizing the provision at Sec. 424.516(d)(1)(iii) which requires physicians, NPPs and physician and NPP organizations to report a change of practice location within 30 days. While we may not revoke the billing privileges of physicians, NPPs and physician and NPP organizations if a change of practice location is reported by the practitioner or organization after the prescribed 30-day timeframe, we will assess an overpayment, if applicable, for the difference in payment rates retroactive to the date the change in practice location occurred. In addition, with limited exceptions such as a

Presidentially-declared disaster under the Robert T. Stafford Disaster

Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (Stafford

Act), physicians, NPPs, and physician and NPP organizations can report a change of practice location in advance of the reportable event. We note that individual practitioners and physician and NPP organizations routinely notify staff, the U.S. Post Office, telephone and electric companies, suppliers, vendors, State medical associations and other practitioner partners prior to a change in practice location.

Accordingly, we believe that it is appropriate that physicians and NPP organizations notify the Medicare contractor in advance of any pending change of practice location, but no later than 30 days after the reportable event.

As such, we will not reprocess claims for those individual practitioners and physician and NPP organizations that do not report a change of practice location prior to a change in practice location where the reported change would result in an underpayment, unless the change of location was the direct result of a Presidentially-declared disaster under the Robert T. Stafford Disaster Relief and Emergency

Assistance Act, 42 U.S.C. 5121-5206 (Stafford Act). We believe that this change will create an incentive for physicians, NPPs, and physician and NPP organizations to report changes in practice locations prior to the change of practice location or, at a minimum, within the 30 days of the reportable event.

Moreover, if we determine that a change of practice location occurred and it has not been reported within the 30 days of the reportable event, we may revoke billing privileges and assess any applicable overpayment for the difference in payment rates retroactive to the date the change in practice location occurred. We believe that the authority to revoke billing privileges has already been established in Sec. 424.535(a)(5)(ii).

We are finalizing the provision at proposed Sec. 424.535(a)(9) which would specify that failure to comply with the reporting requirements specified in Sec. 424.516(d) would be a basis for revocation. Additionally, we are also finalizing the provision we proposed in Sec. 424.565(a), ``Failure to comply with the reporting requirements specified in Sec. 424.516(d) would result in a Medicare overpayment from the date of a final adverse action or a change in practice location.'' In this situation, an overpayment for failure to timely report these changes would be calculated back to the date of the final adverse action or the date of the change in practice location.

Once an overpayment has been assessed, we will follow the overpayment regulations established at 42 CFR Part 405 subpart C.

Based on public comments, we are adding a definition of final adverse action to Sec. 424.502(a). A final adverse action means one or more of the following actions: (1) A Medicare-imposed revocation of any

Medicare billing privileges; (2) Suspension or revocation of a license to furnish health care by any State licensing authority; (3) Revocation or suspension by an accreditation organization; (4) A conviction of a

Federal or State felony

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offense (as defined in Sec. 424.535(a)(3)(i)) within the last 10 years preceding enrollment, revalidation, or re-enrollment; or (5) An exclusion or debarment from participation in a Federal or State health care program. 5. Maintaining Ordering and Referring Documentation

We proposed to add a new Sec. 424.516(f) that would specify, ``A provider or supplier is required to maintain ordering and referring documentation, including the NPI, received from a physician or eligible

NPP. Physicians and NPPs are required to maintain written ordering and referring documentation for 10 years from the date of service.'' We believe that it is essential that providers and suppliers maintain documentation regarding the specific service ordered or referred to a

Medicare beneficiary by a physician or NPP as defined in section 1842(b)(18)(c) of the Act, (which includes but is not limited to nurse practitioners and physician assistants). We believe that ordering and referring documentation maintained by a provider or supplier must match the information on the Medicare claims form. Additionally, we proposed to add Sec. 424.535(a)(10) that would state that failure to comply with the documentation requirements specified in Sec. 424.516(f) would serve as a reason for revocation. For example, a lab submits a claim with Dr. Smith's NPI (1234512345) in the ordering and referring section of the claim form. The number submitted on the claim form should match the documentation in the provider or supplier's records. In addition, we proposed to codify the requirement to maintain ordering and referring documentation as required in the Medicare Program Integrity

Manual (PIM) Publication 100-08, Chapter 5. While the PIM currently requires that providers and suppliers maintain ordering and referring documentation for 7 years from the date of payment, we believe that the industry generally maintains documentation from the date of service.

Accordingly, since there may be a delay in claims submission and subsequent payment for up to 27 months from the date of service, we believe that it would be administratively less burdensome for providers and suppliers to maintain ordering and referring documentation for 7 years from the date of service, rather than requiring providers and suppliers to maintain ordering and referring documentation associated with the date of payment.

We maintain that a provider or supplier should retain the necessary ordering and referring documentation received from physicians and NPPs as defined in section 1842(b)(18)(C) of the Act to assure themselves that coverage criterion for an item has been met. If the information in the patient's medical record does not adequately support the medical necessity for the item, the supplier would be liable for the dollar amount involved unless a properly executed Advance Beneficiary Notice of possible denial has been obtained.

Comment: One commenter urged CMS to adopt its proposal that would specify that a provider or supplier is required to maintain ordering and referring documentation, including the NPI received from the physician or eligible NPP, for 10 years from the date of service, but that this provision only apply to services furnished on or after the effective date of this final rule with comment period.

Response: We agree with this commenter in that we are basing the ordering and referring record retention requirement based upon the date of service, however we are adopting the provision for 7 years from the date of service. We believe that this approach is administratively consistent with current manual record retention policy that requires that suppliers retain ordering and referring documentation for 7 years from the date of billing. We maintain that it is less burdensome for providers and suppliers to maintain ordering and referring documentation for 7 years from the date of service rather than requiring providers and suppliers to maintain ordering and referring documentation associated with the proposed provision for 10 years after the date of payment.

Comment: One commenter disagrees with increasing the retention of ordering and referring documentation beyond the current 7 years from the date of payment. The commenter continued to state that the provision as proposed may represent an additional cost for 3 years of additional record retention.

Response: As stated above, we are establishing an ordering and referring record retention period as 7 years from the date of service.

Comment: One commenter believes that CMS must understand that in virtually all cases, the only information the laboratory receives is the laboratory requisition submitted by the physician.

Response: We continue to believe that it is necessary that providers and suppliers retain ordering and referring documentation for services furnished 7 years from the date of service. However, we understand that the supplier may not maintain the NPI documentation for each service, but the provider or supplier must maintain sufficient documentation to identify the individual who ordered or referred the beneficiary for their services. In addition, upon review, CMS or our contractor may validate the ordering/referring documentation maintained by the billing provider or supplier with the individual practitioner who ordered/ referred the beneficiary for these services.

Comment: One commenter recommends that CMS defer to the judgment of the State boards of pharmacy regarding the length of record retention, and also allow offsite electronic storage of ordering and referring records.

Response: We appreciate the importance of the requirements of State boards of pharmacy; however, we uphold that Medicare is a national program and it is necessary to establish national standards for maintaining the ordering and referring record retention period. We believe that this approach will lead to consistency. Further, the provisions of the final rule do not preclude offsite or electronic storage as long as these records are readily accessible and retrievable.

Comment: One commenter proposes CMS to abandon its proposal for the 10-year record retention period and allow pharmacies to follow record retention requirements under State law.

Response: We appreciate the importance of the requirements of State boards of pharmacy, however we uphold that Medicare is a national program and it is necessary to establish national standards for maintaining the ordering and referring record retention period. We believe that this approach will lead to CMS consistency. While we are not changing our record retention policy to account for different State pharmacy laws, we are revising the proposed 10-year record retention policy and establishing an ordering and referring record retention period as 7 years from the date of service

Comment: One commenter believes that pharmacies should be allowed to maintain their hard-copy records offsite electronically after a certain time.

Response: The provisions of the final rule do not preclude offsite or electronic storage as long as these records are readily accessible and retrievable.

Comment: Several commenters recommended that pharmacies should maintain the prescription record in written form for the greater of 3 years or the requirements in State law, and then allow the prescription to be stored electronically for the remaining years. The commenter continued to state that this would bring consistency to the Medicare

Parts B and D programs, and

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reduce the need to create new storage capacity for paper prescription records.

Response: Since Medicare is a Federal program that already requires a 7-year retention period from the date of billing, we disagree that this change will create a significant burden.

Comment: One commenter stated that the extension from 7 to 10 years would add a substantial recordkeeping burden.

Response: We agree with this commenter and have revised this final rule with comment period to establish an ordering and referring record retention period as 7 years from the date of service.

Comment: One commenter urged CMS to reconsider our position regarding maintaining ordering and referring documentation. In addition, this commenter stated that this change would constitute an unfunded mandate.

Response: We disagree with this commenter that this change is an unfunded mandate because providers and suppliers are already required by CMS' manual instructions to maintain ordering and referring documentation for 7 years from the date of billing.

Comment: One commenter stated that we should allow offsite and electronic storage of ordering and referring records.

Response: The provisions of the final rule do not preclude offsite or electronic storage as long as these records are readily accessible.

Comment: One commenter urged CMS to adopt the proposed requirement for record retention, but only with a provision that such record retention requirements became effective as of the effective date of the final rule. Further, the commenter states that those providers and suppliers that, until now, have not kept ordering and referring documentation for 10 years from the date of service (and were under no other statutory or regulatory requirement to do so) would not be liable and face possible revocation of billing privileges as long as the provider or supplier was in compliance with currently existing requirements.

Response: We agree with this commenter; however, we have revised this final rule to establish the ordering and referring record retention period as 7 years from the date of service.

After reviewing public comments, we are finalizing the provision at proposed Sec. 424.516(f) that would require providers and suppliers to maintain ordering and referring documentation, including the NPI, received from a physician or eligible NPP. Physicians and NPPs are required to maintain written ordering and referring documentation for 7 years from the date of service. In addition, we are finalizing the provision found at Sec. 424.535(a)(10) that states that failure to comply with the documentation requirements specified in Sec. 424.516(f) is a reason for revocation.

Finally, the aforementioned provisions regarding ordering and referring documentation are effective with services furnished on or after the implementation date of this final rule. 6. Revocation of Enrollment and Billing Privileges in the Medicare

Program (Sec. 424.535(h))

Historically, we have allowed providers and suppliers whose

Medicare billing numbers have been revoked to continue billing for services furnished prior to revocation for up to 27 months after the effective date of the revocation. Since we believe this extensive billing period poses significant risk to the Medicare program, we proposed to limit the claims submission timeframe after revocation. In

Sec. 424.535(g) (Redesignated as Sec. 424.535(h), we proposed that revoked physician and NPP organizations and individual practitioners, including physicians and NPPs, must submit all outstanding claims not previously submitted within 30 calendar days of the revocation effective date. We stated that this change is necessary to limit the

Medicare program's exposure to future vulnerabilities from physician and NPP organizations and individual practitioners that have had their billing privileges revoked. We know that some physician and NPP organizations and individual practitioners are able to create false documentation to support claims payment. Accordingly, we stated that the proposed change would allow a Medicare contractor to conduct focused medical review on the claims submitted during the claims filing period to ensure that each claim is supported by medical documentation that the contractor can verify. We also stated that focused medical review of these claims will ensure that Medicare only pays for furnished services by a physician organization or individual practitioner and that these entities and individuals receive payment in a timely manner. Since a physician organization or individual practitioner generally submits claims on a nexus to the date of service, we stated that the proposed change will not impose a significant burden on physician organizations or individual practitioners. In addition, we also proposed to add Sec. 424.44(a)(3) to account for this provision related to the requirements for the timely filing of claims.

Comment: One commenter supports our proposal to limit, to 30 days, the time frame in which a provider whose billing services have been revoked may continue to submit claims for services furnished prior to such revocation.

Response: We appreciate this comment.

Comment: One commenter appreciated our concern regarding the current period of up to 27 months but offered alternative time periods of 60 or 90 days rather than the proposed time period of 30 days.

Response: We are finalizing the provisions at Sec. 424.535(h)

(proposed as Sec. 424.535(g)) that require a revoked physician, NPP or a physician or NPP organization to submit all outstanding claims not previously submitted within 60 calendar days of the effective date of the revocation, (except for revocations identified in Sec. 405.874(b)(2) and Sec. 424.535(f) of this final rule).

Comment: Several commenters encouraged CMS to reset the period of time a provider can submit claims after billing privileges have been revoked from up to 27 months to 6 months, instead of the proposed 30 days.

Response: As stated above, we are finalizing the provisions found at Sec. 424.535(g) (Redesignated as Sec. 424.535(h)) that require a revoked physician, NPP or a physician or NPP organization to submit all outstanding claims not previously submitted within 60 calendar days of the effective date of the revocation, (except for revocations identified in Sec. 405.874(b)(2) and Sec. 424.535(f) (redesignated as

Sec. 424.535(g)) of this final rule).

Comment: One commenter stated that 30 days is simply not enough time to wrap up all of the details of a practice, in addition to the other circumstances associated with a revocation of billing privileges.

Response: We are finalizing the provisions found at Sec. 424.535(h) (proposed as Sec. 424.535(g)) that require a revoked physician, NPP or a physician or NPP organization to submit all outstanding claims not previously submitted within 60 calendar days of the effective date of the revocation, (except for revocations identified in Sec. 405.874(b)(2) and Sec. 424.535(f) (redesignated as

Sec. 424.535(g)) of this final rule).

After reviewing public comments, we are finalizing the provisions found at Sec. 424.535(h) (proposed as Sec. 424.535(g)) that require a revoked physician, NPP or a physician or NPP organization to submit all outstanding claims not previously submitted within 60 calendar days of the effective date of the revocation. Since the physician, NPP or

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a physician or NPP organization is already afforded approximately 30 days notification before the effective date of revocation (except for revocations identified in Sec. 405.874(b)(2) and Sec. 424.535(f)

(redesignated as Sec. 424.535(g)) of this final rule), we believe that almost 90 days is more than sufficient time to file any outstanding claims with the Medicare program.

In addition, we are amending Sec. 424.44(a) to account for this provision related to the requirements for the timely filing of claims.

We are revising the Sec. 424.44(a) to clarify that this provision is consistent with Sec. 424.521 which limits the ability of physicians,

NPPs and physician and NPP organizations to bill retrospectively. The timely filing requirements in Sec. 424.44(a)(1) and (a)(2) will no longer apply to physician, NPPs, or physician or NPP organizations or

IDTFs. 7. Technical Changes to Regulations Text

We proposed to make the following technical changes:

Existing Sec. 424.510(d)(8) would be redesignated as

Sec. 424.517. This revision would separate our ability to conduct onsite reviews from the provider and supplier enrollment requirements.

Existing Sec. 424.520 would be revised and redesignated as Sec. 424.516. This redesignation would move the additional provider and supplier enrollment requirements so that these requirements immediately follow the provider and supplier enrollment requirements.

In new Sec. 424.520, we proposed to specify the effective dates for Medicare billing privileges for the following entities:

Surveyed, certified, or accredited providers and suppliers; IDTFs; and

DMEPOS suppliers.

In Sec. 424.530, we proposed to add the phrase ``in the

Medicare program'' to the section heading to remain consistent with other headings in the subpart.

After reviewing public comments, we are finalizing the following technical changes:

Existing Sec. 424.510(d)(8) has been redesignated as

Sec. 424.517. This revision would separate our ability to conduct onsite reviews from the provider and supplier enrollment requirements.

Existing Sec. 424.520 has been revised and redesignated as Sec. 424.516. This redesignation would move the additional provider and supplier enrollment requirements so that these requirements immediately follow the provider and supplier enrollment requirements.

In new Sec. 424.520, we are adopting the effective dates for Medicare billing privileges for the following entities: Surveyed, certified, or accredited providers and suppliers; IDTFs; and DMEPOS suppliers.

In Sec. 424.530, we are adding the phrase ``in the

Medicare program'' to the section heading to remain consistent with other headings in the subpart.

K. Amendment to the Exemption for Computer-Generated Facsimile (Fax)

Transmissions From the National Council for Prescription Drug Programs

(NCPDP) SCRIPT Standard for Transmitting Prescription and Certain

Prescription-Related Information for Part D Covered Drugs Prescribed for Part D Eligible Individuals 1. Legislative History

Section 101 of the MMA amended title XVIII of the Act to establish a voluntary prescription drug benefit program. Prescription Drug Plan

(PDP) sponsors and Medicare Advantage (MA) organizations offering

Medicare Advantage-Prescription Drug Plans (MA-PDs) and other Medicare

Part D sponsors are required to establish electronic prescription drug programs to provide for electronic transmittal of certain information to the prescribing provider and dispensing pharmacy and dispenser. This includes information about eligibility, benefits (including drugs included in the applicable formulary, any tiered formulary structure and any requirements for prior authorization), the drug being prescribed or dispensed and other drugs listed in the medication history, as well as the availability of lower cost, therapeutically appropriate alternatives (if any) for the drug prescribed. Section 101 of the MMA established section 1860D-4(e)(4)(D) of the Act, which directed the Secretary to issue uniform standards for the electronic transmission of such data.

There is no requirement that prescribers or dispensers implement e- prescribing. However, prescribers and dispensers who electronically transmit prescription and certain other prescription-related information for covered drugs prescribed for Medicare Part D eligible individuals, directly or through an intermediary, are required to comply with any applicable final standards that are in effect. For a complete discussion of the statutory basis for the e-prescribing portions of this final rule with comment period and the statutory requirements at section 1860D-4(e) of the Act, please refer to the

``Background'' section of the E-Prescribing and the Prescription Drug

Program proposed rule published in the February 4, 2005 Federal

(Facsimiles)

In the E-Prescribing and the Prescription Drug Program final rule

(70 FR 67568, November 7, 2005), we adopted the National Council for

Prescription Drug Programs (NCPDP) SCRIPT standard, Implementation

Guide, Version 5, Release 0 (Version 5.0), May 12, 2004, excluding the

Prescription Fill Status Notification Transaction (and its three business cases which include the following: Prescription Fill Status

Notification Transaction-Filled; Prescription Fill Status Notification

Transaction-Not Filled; and Prescription Fill Status Notification

Transaction-Partial Fill) hereafter referred to as ``NCPDP SCRIPT 5.0,'' as the standard for communicating prescriptions and prescription-related information between prescribers and dispensers.

Subsequently, in the June 23, 2006 Federal Register (71 FR 36020), we published an interim final rule with comment period (IFC) that maintained NCPDP SCRIPT 5.0 as the adopted standard, but allowed for the voluntary use of a subsequent backward compatible version of the standard, NCPDP SCRIPT 8.1. In the April 7, 2008 Federal Register, we published a final rule (73 FR 18918) that finalized the June 23, 2006

IFC; effective April 1, 2009, we will retire the NCPDP SCRIPT 5.0 and adopt NCPDP SCRIPT 8.1 as the standard. Hereafter we refer to these standards as ``NCPDP SCRIPT.''

The November 7, 2005 final rule also established an exemption to the requirement to utilize the NCPDP SCRIPT standard for entities that transmit prescriptions or prescription-related information for Part D covered drugs prescribed for Part D eligible individuals by means of computer-generated facsimiles (facsimiles generated by one computer and electronically transmitted to another computer or facsimile machine which prints out or displays an image of the prescription or prescription-related information). Providers and dispensers who use this technology are not compliant with the NCPDP SCRIPT standard. The exemption was intended to allow such providers and dispensers time to upgrade to software that utilizes the NCPDP SCRIPT standard, rather than forcing them to revert to paper prescribing.

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b. Amendment of Exemption

In the CY 2008 PFS proposed rule (72 FR 38194), we proposed to revise Sec. 423.160(a)(3)(i) to eliminate the computer-generated facsimile exemption to the NCPDP SCRIPT standard for the communication of prescription or certain prescription-related information between prescribers and dispensers for the transactions specified in Sec. 423.160(b)(1)(i) through (xii).

Since computer-generated facsimiles retain some of the disadvantages of paper prescribing (for example, the administrative cost of keying the prescription into the pharmacy system and the related potential for data entry errors that may impact patient safety), we believed it was important to take steps to encourage prescribers and dispensers to move toward use of NCPDP SCRIPT. We believed the elimination of the computer-generated facsimile exemption would encourage prescribers and dispensers using this computer- generated facsimile technology to, where available, utilize true e- prescribing (electronic data interchange using the NCPDP SCRIPT standard) capabilities.

We proposed to eliminate the computer-generated facsimile exemption effective 1 year after the effective date of the CY 2008 PFS final rule

(that is, January 1, 2009). We believed that this would provide sufficient notice to prescribers and dispensers who would need to implement or upgrade e-prescribing software to look for products and upgrades that are capable of generating and receiving transactions that utilize NCPDP SCRIPT. It would also afford current e-prescribers time to work with their trading partners to eventually eliminate computer- to-facsimile transactions.

We solicited comments on the impact of the proposed elimination of this exemption. Several commenters concurred with our proposal to eliminate the exemption for computer-generated facsimiles, indicating that eliminating the exemption for computer-generated facsimiles would act as an incentive to move prescribers and dispensers toward true e- prescribing (electronic data interchange using the NCPDP SCRIPT standard), although many commenters suggested that we continue to allow for the use of computer-generated facsimiles in the case of transmission failure and network outages. Less than half of the commenters disagreed with our proposal to eliminate the exemptions for computer-generated facsimiles, citing concerns about increased hardware/software costs, transaction fees, certification, and other activation costs.

Several commenters indicated that the elimination of the exemption could be problematic in certain e-prescribing transactions, namely prescription refill requests, but only one of those commenters offered substantiation to support this assertion. Absent receipt of substantial industry data on the impact of the elimination of the computer- generated facsimile exemption on prescription refill requests, and not considering the industry's comments about prescription refill requests to constitute widespread concern regarding the prescription refill request function, in the CY 2008 PFS final rule with comment period (72

FR 66396), we amended the exemption to permit the use of computer- generated facsimiles only in cases of temporary/transient network transmission failures, effective January 1, 2009. 3. Proposal for CY 2009

Following the publication of the CY 2008 PFS final rule with comment period, we received additional information regarding how the modification of the exemption for computer-generated faxing to eliminate use of computer-generated faxing in all instances other than temporary/transient network transmission failures would adversely impact the electronic transmission of prescription refill requests. The submitted information offered additional support to the claim that in all instances other than temporary/transient network transmission problems, elimination of the use of computer-generated facsimiles would adversely impact the electronic transmission of prescription refill requests. These later materials substantiated the earlier claims that the elimination of the exemption in all instances other than temporary/ transient network transmission failures would force dispensers who e- prescribe and use these transactions to revert to paper prescribing.

These materials offered more specific information regarding the economic and workflow impacts associated with the elimination of the exemption for computer-generated facsimiles in all instances other than temporary/transient network transmission failures that was not forthcoming in the prior public comment period for the CY 2008 PFS proposed rule. We also received unsolicited comments on this issue during the comment period for the November 16, 2007 Part D e- prescribing proposed rule (proposing the adoption of certain final Part

D e-prescribing standards and the use of NPI in Part D e-prescribing transactions) (72 FR 64900). As a result of the new information, we reexamined this issue and proposed additional modifications to the computer-generated facsimile exemption in the CY 2009 PFS proposed rule

(73 FR 38502).

Dispensers have indicated that they use computer-generated facsimiles for the majority of prescription refill requests, in particular when communicating with prescribers that have not adopted e- prescribing. Currently, regardless of how the initial prescription was received by the pharmacy (that is, orally, via e-prescribing, telephone, paper, or facsimile) nearly all prescription refill requests from chain pharmacies to prescribers are sent electronically, either via an e-prescribing application or via computer-generated facsimile.

When a prescription is received by a dispenser electronically, the prescription refill request is sent to the prescriber via the same technology. However, where the dispenser knows that the prescriber lacks e-prescribing capability or has not activated it, or where the prescriber does not respond to the request sent to his or her prescribing device, the prescription refill request is sent or resent via computer-generated facsimile. Commenters stated that the vast majority of computer-generated facsimiles sent today from prescribers to pharmacies are not electronic data interchange (EDI) transmissions, but usually prescription refill requests sent from pharmacies to prescribers who do not conduct true e-prescribing and, in many cases, do not engage in any electronic transactions at all. One national drug store chain estimates that it produces approximately 150,000 computer- generated facsimile prescription refill requests every day.

The workflow and process for filling prescriptions would be significantly disrupted if these computer-generated facsimile transmissions were prohibited. Dispensers and other staff would be forced to revert back to making phone calls or using a stand-alone facsimile machine to contact prescribers each time a refill is requested. Commenters indicated that not only would this be counterproductive to the advances and efficiencies made in pharmacy practice, it would impose an undue administrative burden on dispensing pharmacies and pharmacists.

As a result of this additional information regarding the larger than anticipated impact of the elimination of computer-generated facsimiles for the prescription refill request transaction, we proposed to further amend the

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computer-generated facsimile exemption to also allow for an exemption from the NCPDP SCRIPT standards for electronic prescription refill request transactions that are conducted by computer-generated facsimiles when the prescriber is incapable of receiving electronic transmissions using the NCPDP SCRIPT standard. We proposed to retain the computer-generated facsimile exemption in instances of transient/ temporary network transmission failures, effective January 1, 2009. We also proposed to revisit the computer-generated facsimile exemption for the purpose of ultimately eliminating it for the prescription refill request transaction found at Sec. 423.160(b)(1)(vii), and specifically solicited industry and interested stakeholder comments regarding what would constitute an adequate time to allow the industry to transition to the use of the NCPDP SCRIPT standard.

We also solicited industry input on any other e-prescribing transaction that might be similarly adversely impacted by the elimination of computer-generated facsimiles in all instances other than transient/temporary network transmission failures.

We received 52 relevant and timely public comments on our proposal to further amend the exemption of computer-generated facsimiles from the NCPDP SCRIPT standard for Part D e-prescribing to include an exemption for refill request transactions with prescribers who are not capable of e-prescribing using the adopted NCPDP SCRIPT standard as detailed in the CY 2009 PFS proposed rule (73 FR 38600). While the comments were few in number, they tended to provide multiple detailed comments on what had been proposed.

Comment: Several commenters recommended that we reinstate the exemption for computer-generated facsimiles in its entirety. The commenters referenced the Medicare Improvements for Patients and

Providers Act of 2008 (MIPPA) and its potential to help drive e- prescribing adoption, stating that the e-prescribing incentives contained in the MIPPA provide a better, more transitional path towards that goal.

One commenter recommended that the elimination of the computer- generated facsimile exemption coincide with the incentive provisions contained in the MIPPA legislation. The commenter noted the eventual penalty for Medicare providers who do not adopt e-prescribing by the year 2012. The commenter also stated that structuring the elimination of the computer-generated facsimile exemption to coincide with this date would allow organizations the time needed to appropriately implement e-prescribing.

Other commenters recommended that we adopt a computer-generated facsimile exemption for pharmacies in areas where prescribers who do not e-prescribe fall under the ``significant hardship'' exception contained in the MIPPA. Commenters also recommended that the computer- generated facsimile exemption be further modified so as to allow for use of the computer-generated facsimile exemption that was adopted in the November 7, 2005 final rule (the ``original'' computer-generated facsimile exemption) until 2014, when provider disincentives/penalties are maximized under the MIPPA, at which time a study could be conducted to determine the number of prescriptions being e-prescribed. We assume that the commenters' intent would be to use the information gleaned from such a study as an indicator of whether or not e-prescribing had reached an acceptable level of adoption among providers and pharmacies, and that if an acceptable level of adoption among providers and pharmacies had been demonstrated, that the computer-generated facsimile exemption could be eliminated.

Similarly, other commenters suggested that the exemption should be eliminated in 2012 when disincentives under the MIPAA e-prescribing incentive program go into effect, or in 2014, when e-prescribing provider disincentives/penalties are maximized under the MIPPA. Another commenter urged that we reinstate the original (from the November 7, 2005 final rule (70 FR 67568)) exemption for computer-generated facsimiles in its entirety, not just for prescription refill requests and transmission failures.

Response: We agree with the commenters regarding the impact of the

MIPPA. In general, the MIPPA provides payment incentives for eligible professionals who are ``successful electronic prescribers'' as that term is defined in the law. The incentive payments are 2 percent of the eligible professional's allowed charges under the PFS for CY 2009 through CY 2010; 1.5 percent in CY 2011 through CY 2012, and a 0.5 percent in CY 2013. Conversely, the MIPPA calls for payment reductions, or disincentives, for those who are not successful electronic prescribers beginning in CY 2012. For CY 2012, the payment amount under the PFS will be reduced by 1 percent for eligible professionals who are not successful electronic prescribers. In subsequent years, the payment reduction is increased by 0.5 percent each year through CY 2014, and then is fixed at 2 percent for later years. For more information on the e-prescribing provisions of the MIPPA, please see section 132 of the

MIPPA legislation enacted on July 15, 2008 (Pub. L. 110-275, http:// frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_ laws&docid=f:publ275.110.pdf).

We envision that the MIPPA-created incentive payments for those prescribers who successfully implement electronic prescribing in accordance with MIPPA guidelines will provide the ``tipping point''--an adequate level of industry adoption of e-prescribing using electronic data interchange (EDI) that would in turn move the entire industry toward widespread e-prescribing adoption. We believe that data from the e-prescribing incentive program under the MIPPA and eventually from

Part D e-prescribing will offer evidence of the rate of e-prescribing adoption, therefore making a study of e-prescribing for purposes of determining e-prescribing adoption rates unnecessary.

We analyzed the industry feedback that we received in response to the computer-generated facsimile exemption proposals in the CY 2009 PFS proposed rule in light of the recent MIPPA legislation. While the MIPPA legislation was not yet been enacted at the time of the CY 2009 PFS proposed rule's publication, it was enacted in time for commenters to discuss its provisions in their comments to our proposals. Based on

MIPPA-based and other comments received in response to our proposal to further modify the computer-generated facsimile exemption, and taking into consideration the potential positive impact on the industry of the

Part D e-prescribing incentives included in the recently-enacted MIPPA legislation, we are reinstating the original exemption for computer- generated facsimiles effective January 1, 2009. We also agree with those commenters who suggested that the computer-generated facsimile exemption should be eliminated (in all instances other than transient/ temporary network transmission failures) once provider e-prescribing disincentives under the MIPAA program are initiated.

Although several commenters suggested that we should wait until the disincentives are maximized in 2014, we feel that it is more appropriate to eliminate the reinstated exemption (in all instances other than temporary/transient network transmission problems) sooner, when the MIPPA e-prescribing program disincentives for those who are not successful electronic

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prescribers begin in 2012. We believe that the January 1, 2012 compliance date for the elimination of the computer-generated facsimile exemption (in all instances other than temporary/transient transmission problems) will take advantage of the momentum that will be built by the e-prescribing incentive program under the MIPPA, and affords the industry an additional 3 years from the effective date of this final rule with comment period to move toward true e-prescribing. We also believe that the January 1, 2012 date will enable the industry to begin taking advantage of the benefits of e-prescribing sooner, and in so doing pass those advantages on to their patients in the way of increased patient safety and convenience. Therefore effective January 1, 2012, we will eliminate the reinstated exemption to the requirement to utilize the NCPDP SCRIPT standard for entities that transmit prescriptions or prescription-related information for Part D covered drugs prescribed for Part D eligible individuals by means of computer- generated facsimiles in all instances other than transient/temporary network transmission failures.

We do not believe that a computer-generated facsimile exemption is needed for pharmacies in areas where prescribers who do not have access to the technology that would allow them to e-prescribe under the

``significant hardship'' exception contained in the MIPPA. We would expect that by the year 2012, the effective date of the elimination of the computer-generated facsimile exemption (in all instances other than temporary and transient network transmission failures), that most areas would have the telecommunication and/or Internet connectivity capacity to allow providers to conduct e-prescribing, and an exemption is not warranted in the rare instance where this may not be the case.

Comment: We received feedback from 19 commenters who agreed with the proposal to extend the exemption to computer-generated facsimiles for the prescription refill request transaction in cases where the physician is not NCPDP SCRIPT enabled.

Response: We agree with commenters. This issue will be resolved with this final rule's reversal of the CY 2008 PFS final rule's e- prescribing provisions that would have eliminated the computer- generated faxing exemption (in all instances other than temporary and transient network transmission failures) effective on January 1, 2009, and concurrent reinstatement of the original exemption for computer- generated facsimiles from the November 7, 2005 final rule effective

January 1, 2009. However, we will eliminate the reinstated exemption for computer-generated facsimiles (in all instances other than transient/temporary network transmission failures) effective when the

MIPPA e-prescribing program disincentives take effect on January 1, 2012.

Comment: Some commenters expressed opposition to the proposed elimination of the exemption for computer-generated facsimiles in all instances other than temporary/transient network transmission failures.

One commenter erroneously identified January 1, 2010 as the proposed compliance date, but still asked for additional time for NCPDP SCRIPT- noncompliant providers to become compliant with the NCPDP SCRIPT standard.

Another commenter stated that the overall e-prescribing adoption rate has not met a critical mass to justify a January 2009 deadline for the elimination of the computer-generated facsimile exemption in all instances other than transient/temporary network transmission failures.

The commenter noted that with the effective date fast approaching, unless the computer-generated facsimile exemption is modified once again, many organizations will have to hastily implement e-prescribing solutions or revert back to paper prescribing.

Response: We agree with commenters that it is in the best interests of the industry and consumers that the CY 2008 PFS final rule's modifications to the computer-generated facsimile exemption be reversed and the broad exemption originally created in the November 7, 2005 final rule for computer-generated facsimiles in Part D e-prescribing be reinstated to prevent a reversion by providers to paper prescriptions, and a reversion by pharmacies to traditional paper faxing. Therefore, by this rule we have reinstated the original exemption for computer- generated facsimiles effective January 1, 2009. However, we will eliminate the reinstated computer-generated facsimiles exemption in all instances other than transient/temporary network transmission failures effective when the MIPPA e-prescribing program disincentives take effect on January 1, 2012.

Comment: Some commenters requested clarification of our proposed amendment to the exemption for computer-generated facsimiles. One commenter stated that their customers believe that all Part D prescriptions, without exception, must be sent via electronic transmission as of January 1, 2009, and otherwise they may be liable for conducting an ``illegal'' transaction. To avoid undue hardship, costs, and confusion, the commenter asked that CMS clearly specify that e-prescribing is preferred but still voluntary for providers and dispensers; and those prescribers not currently e-prescribing under the

Medicare Part D pharmacy benefit program may still write paper prescriptions, or call in or fax their prescriptions using a traditional paper fax machine to a pharmacy.

Another commenter asked CMS to clarify that providers who use prescription writing systems that enable computer based facsimiles but do not enable NCPDP SCRIPT transactions are not subject to the provisions of the computer-generated facsimile exemption. One commenter asked CMS to clarify the definition of a ``true'' e-prescribing system.

Response: We recognize that there might be some confusion for prescribers and dispensers with the elimination of certain portions of the computer-generated facsimile exemption. In the November 7, 2005 e- prescribing final rule (70 FR 67568), we defined ``e-prescribing'' to mean the transmission, using electronic media, of prescription or prescription-related information, between a prescriber, dispenser, PBM, or health plan, either directly or through an intermediary, including an e-prescribing network.

As we noted above, section 101 of the MMA amended title XVIII of the Act to establish the Part D prescription drug benefit program. As part of that program, the Congress required the establishment of a

``voluntary'' e-prescribing program. It is voluntary in that providers and dispensers are not required to conduct e-prescribing for Medicare covered drugs prescribed for Medicare Part D eligible beneficiaries, but if they do conduct such e-prescribing, they must do so using the applicable standards that are in effect at the time of the transmission. Part D sponsors, in turn, must support e-prescribing so that providers and dispensers who wish to conduct e-prescribing transactions with plans will be able to do so using the adopted standards that are in effect at the time of the transaction. We refer those commenters with questions regarding the creation and scope of the

Medicare Part D e-prescribing program to the ``Background'' section of the E-Prescribing and the Prescription Drug Program proposed rule published in the February 4, 2005 Federal Register (70 FR 6256)

In the CY 2008 PFS proposed rule (72 FR 38194), we proposed to revise

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Sec. 423.160(a)(3)(i) to eliminate the computer-generated facsimile exemption to the NCPDP SCRIPT standard for the communication of prescription or certain prescription-related information between prescribers and dispensers for the transactions specified in Sec. 423.160(b)(1)(i) through (xii). In keeping with the comments that we received, we finalized modifications that required prescribers and dispensers to use NCPDP SCRIPT compliant e-prescribing software when they conduct e-prescribing transactions for Part D covered drugs that are prescribed for Part D eligible individuals in all instances other than transient/temporary network transmission failures, effective

January 1, 2009. Those prescribers who choose not to e-prescribe Part D covered drugs for Part D eligible individuals can continue to use non- computer-generated facsimiles as a means to deliver such prescriptions to a dispenser.

Providers who use electronic prescription writing systems that are only capable of producing computer-generated facsimiles are not in conformance with the adopted standards because they do not transmit information using the adopted NCPDP SCRIPT standard. Those who utilize their NCPDP SCRIPT enabled systems to produce computer-generated facsimiles are likewise not in compliance with the adopted standards because computer-generated facsimiles on these systems also do not use the adopted standard. We believed that eliminating the exemption (in all instances other than transient/temporary network transmission failures) might encourage those with NCPDP SCRIPT capabilities that have not been activated to use the NCPDP SCRIPT standard in electronic data interchanges, and those without such capabilities to upgrade their current software products, or, where upgrades are not available, to switch to new products that would enable such true e-prescribing.

We believe that eliminating the computer-generated facsimile exemption in 2012 would provide sufficient notice to prescribers and dispensers who would need to implement or upgrade e-prescribing software to look for products and upgrades that are capable of generating and receiving transactions that utilize NCPDP SCRIPT.

Eliminating the reinstated computer-generated facsimile exemption in 2012 would also afford current e-prescribers time to work with their trading partners to eventually eliminate the use (in all instances other than transient/temporary network transmission failures) of computer-generated facsimiles in e-prescribing transactions.

From our analysis of the public comments that asked that the elimination of the computer-generated facsimile exemption (in all instances other than temporary/transient network transmission failures) be reversed, and in view of the recent MIPPA legislation that provides a more powerful incentive to providers to e-prescribe in accordance with the standards adopted under Medicare Part D, we are reversing the modifications to the computer-generated facsimile exemption that were made in the CY 2008 PFS final rule with comment period and reinstating the original computer-generated facsimile exemption that was adopted in the November 7, 2005 e-prescribing final rule in its entirety, effective January 1, 2009. However, we will eliminate the reinstated exemption for computer-generated facsimiles in all instances other than transient/temporary network transmission failures when the MIPPA e- prescribing program disincentives take effect on January 1, 2012.

Comment: Several commenters who agreed with our proposal to eliminate the computer-generated facsimile exemption (in all instances other than transient/temporary network transmission failures) suggested that we delay the January 1, 2009 effective date stated in the CY 2008

PFS final rule with comment period. One commenter urged CMS to conduct studies on the barriers to use of NCPDP SCRIPT compliant systems, and then work with stakeholders to identify pathways toward more widespread use of e-prescribing systems. Another commenter noted that the recent merger of the two major e-prescribing information exchange networks still may hold unforeseen consequences for those vendors who have been previously certified or are in the process of being certified by either of those two networks. The commenter stated that any software changes that the network may demand as a result of their merger may take time to develop, and as a result, the effective date should be delayed.

A few commenters said that we should tie the computer-generated facsimile exemption compliance to the April 1, 2009 compliance date of the most recent round of final e-prescribing standards. One commenter suggested that we delay the effective date of the CY 2008 PFS final rule with comment period modifications to the computer-generated facsimile exemption to 2012, when wireless broadband upload connectivity is expected to achieve a speed of faster than 1MB/second.

Response: We do not see a correlation between the e-prescribing network certification process, and the commenter's request to delay the elimination of the computer-generated facsimile exemption based on what may or may not take place in that process. Additionally, the process for vendors to certify their products to an e-prescribing information exchange network is a marketplace issue to which we are not a party.

We understand that some prescribers and dispensers may not have been prepared to e-prescribe using the adopted standards by the January 1, 2009 effective date of the CY 2008 PFS final rule's e-prescribing provisions. However, with this final rule's reversal of those modifications and reinstatement of the original computer-generated facsimile exemption that was adopted in the November 7, 2005 e- prescribing final rule in its entirety, effective January 1, 2009, we believe we have addressed commenters' concerns regarding effective dates. However, we will eliminate the reinstated exemption for computer-generated facsimiles in all instances other than transient/ temporary network transmission failures when the MIPPA e-prescribing program disincentives take effect on January 1, 2012.

Comment: A comment concerning the computer-generated facsimile exemption issue relative to non-NCPCP SCRIPT enabled pharmacies

(including many independent pharmacies) stated that there are still significant segments of the retail pharmacy market not yet in a position to receive electronic prescriptions because they are only facsimile-enabled. The commenter cited national prescription information exchange network data showing that only about 42,000 of the nation's pharmacies are NCPDP SCRIPT e-prescribing enabled, and about 20,000 of the nation's pharmacies are only manual (traditional paper- based) facsimile or computer-generated facsimile-enabled.

One commenter stated that e-prescribing technology has not yet been perfected by its developers, and that the receiving parties (that is, pharmacies) have not fully integrated this technology into their workflows. The commenter also indicated that use of e-prescribing technology is dependent on the availability of telecommunications services and Internet connectivity, and this is problematic especially in rural areas where there may be a lack of such telecommunications and/or Internet connectivity services needed to support e-prescribing systems.

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A vendor expressed concern that their client pharmacies that rely solely on computer-generated facsimiles may not be able to send or receive computer-generated facsimile transmissions through national prescription information exchange networks after January 1, 2009.

Response: We recognize that pharmacies that are not now conducting e-prescribing transactions using the NCPDP SCRIPT standard will incur costs to implement this capability, and that pharmacies will likely experience an increase in e-prescribing transaction volumes and costs as utilization of such transactions increases.

We agree that independent pharmacies and pharmacies that employ only computer-generated facsimile capabilities need to be given the opportunity to upgrade their systems and that elimination of the computer-generated facsimile exemption (in all instances other than transient/temporary network transmission failures) would place them at a disadvantage at a time when the MIPPA incentive program is expected to generate increased e-prescribing volumes. Therefore, for this reason and the other reasons stated herein, we are reversing the modifications to the computer-generated facsimile exemption that were made in the CY 2008 PFS final rule with comment period and reinstating the original computer-generated facsimile exemption that was adopted in the November 7, 2005 e-prescribing final rule in its entirety, effective January 1, 2009. However, we will eliminate the exemption for computer-generated facsimiles in all instances other than transient/temporary network transmission failures when the MIPPA e-prescribing program disincentives take effect on January 1, 2012.

Comment: We received comments requesting confirmation that the proposed revisions to the computer-generated facsimile exemption would not now apply to long term care providers. Another asked that CMS allow long term care facilities to continue to transmit prescriptions via computer-generated facsimile to pharmacies that are not yet using systems capable of receiving NCPDP SCRIPT transactions appropriate to this setting (NCPDP SCRIPT Version 10.2 or higher). A professional association noted that eliminating the exemption for computer-generated facsimiles (in all instances other than transient/temporary network transmission failures) is unlikely to spur adoption among long term care providers and could, if left standing, force some facilities to resort to manual facsimiles. The commenter also urged CMS to eliminate the e-prescribing exemption for long term care facilities.

Response: In Sec. 423.160(a)(3)(iii), long term care facilities were specifically exempted from the requirement to use the adopted standards in e-prescribing under Medicare Part D due to their unique workflows and complexities associated with prescribing for patients in long term care settings. This exemption remains in effect for long term care facilities. Therefore, long term care facilities may continue to use computer-generated facsimiles, and such facilities will continue to be exempt from the requirement to use the NCPDP SCRIPT Standard in prescription transactions between prescribers and dispensers where a non-prescribing provider is required by law to be a part of the overall transaction process.

Comment: Comments regarding other issues relevant to e-prescribing in general, and the elimination of the computer-generated facsimile exemption (in all instances other than transient/temporary network transmission failures) specifically included comments requesting amendments to the computer-generated facsimile exemption that would address when a prescriber or dispenser is prohibited from using the

NCPDP SCRIPT standard for e-prescribing. The commenter noted that the

Drug Enforcement Administration's (DEA) prohibition of e-prescribing of controlled substances would prevent a provider from prescribing such controlled substances under the Part D program in accordance with the adopted standards. One commenter stated that vendors would have to disable electronic communication of prescriptions from their client prescribers through the prescription information exchange network to those pharmacies that are only computer-generated facsimile-enabled.

The vendor assumed that if their client prescriber attempts to send those prescriptions electronically that the prescription will be rejected by the prescription information exchange network because the pharmacy is not activated with the network for electronic transactions using the NCPDP SCRIPT standard. This same commenter noted that the network has heretofore insulated the prescriber from having to be concerned with whether or not the patient's choice of pharmacy was enabled to receive prescriptions in a particular way. After the proposed January 2009 compliance date, the commenter felt that additional burdens would be placed on the prescriber to obtain this information from the patient up front, or could compel patients to make different pharmacy choices which could result in lost business for pharmacies that are only facsimile-enabled.

Response: The DEA has authority through the Controlled Substances

Act over the electronic prescribing of controlled substances, and does not currently allow for the electronic prescribing of Schedule II drugs. As such substances currently may not be prescribed electronically, there is no conflict of law at this time. As noted previously, e-prescribing under Medicare Part D is voluntary for prescribers and dispensers--they are not required to issue prescriptions in electronic form. Although the DEA has published a notice of proposed rulemaking to allow for the electronic prescribing of controlled substances, we have no indication as to when the DEA will make a final determination on this issue. We continue to work with the

DEA to help facilitate a solution that addresses both their enforcement requirements with respect to the electronic prescribing of controlled substances, and the needs of the healthcare community for a solution that is interoperable with existing e-prescribing systems, scalable and commercially viable.

After reviewing these comments, in the interest of patient care and safety, and to foster the adoption of true e-prescribing among prescribers and dispensers, we are reversing the modifications to the computer-generated facsimile exemption that were made in the CY 2008

PFS final rule with comment period and reinstating the original computer-generated facsimile exemption that was adopted in the November 7, 2005 e-prescribing final rule, effective January 1, 2009. However, we will also eliminate the reinstated exemption for computer-generated facsimiles in all instances other than transient/temporary network transmission failures when the MIPPA e-prescribing program disincentives take effect on January 1, 2012.

L. Comprehensive Outpatient Rehabilitation Facilities (CORF) and

Rehabilitation Agency Issues

Comprehensive outpatient rehabilitation facilities (CORFs) and rehabilitation agencies are Medicare providers that are certified to provide certain rehabilitation services. Currently covered CORF clinical services and rehabilitation agency services are paid through the PFS.

In the CY 2008 PFS final rule with comment period (72 FR 66399), we

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revised the CORF regulations at 42 CFR parts 410 and 413 to ensure that the regulations reflected the statutory requirements applicable to

CORFs under sections 1834(k) and 1861(cc) of the Act. Many of these changes were technical in nature. Specifically, the regulatory changes:

(1) Revised the definitions of ``physicians' services,'' ``respiratory therapy services,'' ``social and psychological services,'' ``nursing services,'' ``drugs and biologicals,'' and ``supplies and durable medical equipment,'' and ``home environment evaluation''; (2) amended the payment provisions for CORF services; and (3) made other clarifications and changes to the conditions for coverage for CORF services.

In the CY 2009 PFS proposed rule, we addressed the comments received in response to the CY 2008 PFS final rule with comment period

(72 FR 66222), proposed new provisions, and proposed revising other provisions. We solicited comments on all of the proposed changes. 1. Personnel Qualifications

We stated in the CY 2008 PFS final rule with comment period that we would propose updated qualifications for respiratory therapists in future rulemaking (72 FR 66297). It has been our policy that only the respiratory therapist (and not the respiratory therapy technician), who possesses the educational qualifications necessary to provide the level of respiratory therapy services required, is permitted to provide respiratory therapy in a CORF setting.

In the CY 2008 PFS final rule with comment period, we received a comment indicating that our regulations were outdated and did not conform to current respiratory therapy professional standards.

Specifically, the American Association for Respiratory Care (AARC) stated that the terms ``certified respiratory therapist (CRT)'' and the

``registered respiratory therapist (RRT)'' have replaced the terms

``respiratory therapy technician'' and ``respiratory therapist,'' respectively. In addition, the qualifications for CRTs and RRTs differ from those applicable to respiratory therapy technicians and respiratory therapists. The CRT designation is awarded after an individual successfully passes the entry-level respiratory therapy examination. In order to be eligible for the RRT examination, an individual must be a graduate of an advanced level respiratory therapy educational program and have obtained the RRT credential.

We proposed to revise Sec. 485.70(j) of the Conditions of

Participation of CORF services--setting forth the personnel qualifications for respiratory therapists in CORFs--to be consistent with current qualification requirements for RRTs, as recommended by

AARC. We also proposed to delete Sec. 485.70(k), which sets forth personnel qualifications for CRTs (previously referred to as respiratory therapy technicians) in CORFs. In the past, we have not reimbursed CORFs for respiratory therapy services provided by respiratory therapy technicians or CRTs, and we believe that removing the technician definition would clarify our position. We stated that we believed that current medical standards continue to require that the provision of skilled respiratory therapy services to patients in the

CORF setting be furnished by RRTs. While CRTs furnish general respiratory care procedures and may assume some clinical responsibility for specified respiratory care modalities involving the application of therapeutic techniques under the supervision of an RRT or a physician, the educational qualifications that a RRT possesses allow him or her to evaluate, treat, and manage patients of all ages with respiratory illnesses. RRTs participate in patient education, implement respiratory care plans, apply patient-driven protocols, follow evidence-based clinical practice guidelines, and participate in health promotion, disease prevention, and disease management. RRTs also may be required to exercise considerable independent judgment.

This was implemented in the CY 2002 PFS final rule with comment period (66 FR 55246 and 55311) and the CY 2003 PFS final rule with comment period (67 FR 79966 and 79999) when we developed and discussed

G codes, CORF respiratory therapy services, and specifically recognized the RRT as the appropriate level of personnel to provide these CORF services. Finally, the CORF regulations at Sec. 485.58(d)(4) state that as a condition of participation for CORFs, CORF personnel must meet the qualifications described at Sec. 485.70.

For CY 2009, to maintain consistency in the conditions of participation for both CORFs, home health agencies (HHAs), and other outpatient service providers, we proposed to amend the material addressing personnel qualifications in Sec. 485.70. Specifically, we proposed to amend paragraphs Sec. 485.70(c) and Sec. 485.70(e) by referencing the personnel qualifications for HHAs at Sec. 484.4. This change would align CORF personnel requirements not only with HHA requirements, but also with other regulations in Part 485 addressing provision of physical therapy, speech-language pathology, and occupational therapy services.

Also, at 485.58(a)(1)(i), we proposed to amend the duties of a CORF physician to include medical supervision of nonphysician staff. This change conforms to changes made to the CORF conditions for coverage in the CY 2008 PFS final rule with comment period. We believe that adding medical supervision of nonphysician staff to the duties of CORF physicians more accurately reflects the duties and responsibilities of the CORF physician. We also believe that this change could increase the quality of care provided to patients of CORFs.

The following is a summary of the comments received concerning

Personnel Qualifications and our responses.

Comment: Commenters generally supported our proposed changes. We received a comment that supported the spirit of our proposed changes to the definitions of respiratory therapists and provided further clarification regarding current professional standards. Specifically, in previous comments, the commenter noted that the term ``respiratory therapy technician'' is an obsolete term. This is because today's curriculum and educational standards are no longer structured to teach at a technician level.

The commenter noted that, in our discussion of the issue in the proposed rule, we stated that it was AARC's belief that the term

``certified respiratory therapist'' (CRT) had replaced the obsolete term ``respiratory therapy technician'' and the term ``registered respiratory therapist'' (RRT) has replaced the term ``respiratory therapist.'' The commenter informed us that our statement was incorrect. According to the commenter, today's educational programs prepare students for the registry (RRT) examinations administered by the National Board for Respiratory Care (NBRC). Before graduates are eligible to sit for the RRT examinations they must first pass the

NBRC's entry-level examination, which results in the CRT credential.

Thus the CRT-credentialed individual is considered an ``entry-level respiratory therapist,'' but unlike other allied health professions, the terms ``technician'' or ``assistant'' are not used in the respiratory therapy profession.

According to AARC, in the profession today, it is accepted clinical and medical terminology that individuals holding the credentials of both CRT and RRT are known simply as ``respiratory therapists.'' Also, most State laws that require licensing of respiratory therapists make no distinction in the

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license as to whether the individual holds a credential of CRT or RRT.

They are both licensed as ``respiratory therapists.'' To the best of

AARC's knowledge, there are only six States that require a separate license for a CRT or a RRT. AARC recommended that the proposed definition be revised.

Since CMS uses the term ``respiratory therapist'' in other regulatory provisions and manual instructions where applicable, AARC recommended that CMS delete the word ``registered'' from the proposed definition. This would also be consistent with the terms ``physical therapist'' and ``occupational therapist'' used to define qualified personnel in those professions.

AARC also believes that CMS can ensure that only registered respiratory therapists, and not individuals holding only the CRT, meet the personnel qualifications by revising the curriculum requirements to require that respiratory therapists have passed the registry examination administered by the NBRC. AARC also noted that the name of the Board administering the certification and registry exams is the

NBRC, not the National Board for Respiratory Therapy, Inc.

Response: We thank the commenters for their support of our proposed revisions. We believe that the comments provided by AARC reflect and further clarify our intent to provide appropriate respiratory care to patients served by CORFs. We want to ensure that only respiratory therapists with the highest level of education and training can furnish respiratory therapy services in a CORF. Therefore, only those individuals holding the credential of registered respiratory therapist

(RRT) conferred by the NBRC would qualify. Qualifying by being

``eligible to take the registry examination,'' as we proposed, results in the unintended consequence of permitting CRTs who have not yet taken the registry exam to meet the personnel qualifications.

As a result of the public comments, we are finalizing the proposed revisions that reference personnel qualifications for HHAs at Sec. 485.70(c) and (e). We are also finalizing our proposed revision to

Sec. 485.58(a)(i)(1) that amends the duties of CORF physicians to include medical supervision of nonphysician staff (we received no comments on this provision). We are adopting the revisions to the personnel qualifications for respiratory therapists at Sec. 485.70(j) as suggested by AARC, to read as follows:

(j) A respiratory therapist must--

(1) Be licensed by the State in which practicing, if applicable; and

(2) Have successfully completed a nationally-accredited educational program that confers eligibility for the National Board for Respiratory

Care (NBRC) registry exams, and have passed the registry examination administered by the NBRC, or

(3) Have equivalent training and experience as determined by the

National Board for Respiratory Care (NBRC) and passed the registry examination administered by the NBRC. 2. Social and Psychological Services

In the CY 2008 PFS final rule with comment period (72 FR 66297), we clarified that all CORF services, including social and psychological services, must directly relate to or further the rehabilitation goals established in the physical therapy, occupational therapy, speech- language pathology, or respiratory therapy plan of treatment. We believe that using a full range of clinical social and psychological

CPT codes to describe CORF social and psychological services is inappropriate because social and psychological CORF services do not include independent clinical treatment of mental, psychoneurotic, and personality disorders. CPT codes 96150 through 96154 and CPT codes 90801 through 90899 are inappropriate for CORF use because all of these

CPT codes represent full-scale clinical treatment for these disorders.

As we stated in the CY 2008 PFS final rule with comment period, we believe that for purposes of providing care in a CORF, social and psychological services should represent only case management and patient assessment components as they relate to the rehabilitation treatment plan (72 FR 66297 through 66298). Consequently, after notice and comment, we changed our policy and payment for CORF social and psychological services; these services may no longer address a CORF patient's mental health diagnoses except insofar as they relate directly to other services provided by the CORF.

We specified in the CY 2008 final rule with comment period (72 FR 66298) that only the CPT code 96152 for health and behavior intervention (with the patient) could be used to bill for CORF social and psychological services. This code was part of a series of codes that was created by CPT in 2002 to address health and behavior assessment issues. These services are offered to patients who present with established illnesses or symptoms, who are not diagnosed with mental illness, and may benefit from evaluations that focus on the biopsychosocial factors related to the patient's physical health status, such as patient adherence to medical treatment, symptom management and expression, health-promoting behaviors, health-related risk-taking behaviors, and overall adjustment to medical illness. We also adopted the more limited definition of CORF social and psychological services in Sec. 410.100(h) (72 FR 66399). The regulations state that social and psychological services include the assessment and treatment of an individual's mental and emotional functioning and the response to and rate of progress as it relates to the individual's rehabilitation plan of treatment, including physical therapy services, occupational therapy services, speech-language pathology services, and respiratory therapy services.

We also noted that a HCPCS G-code could more accurately describe these unique CORF services, but believed that it was inappropriate to create such a G-code in the final rule with comment period without first proposing to do so in proposed rulemaking.

Therefore, we proposed to create a CORF specific G-code, GXXX5,

Social work and psychological services, directly relating to and/or furthering the patient's rehabilitation goals, each 15 minutes, face- to-face; individual (services provided by a CORF-qualified social worker or psychologist in a CORF), to accurately describe the unique social and psychological services provided by CORF staff and to establish appropriate payment for these services. We proposed to use salary and wage data from the Bureau of Labor Statistics to institute a blended social worker/psychologist clinical labor category using a price per minute rate of $0.45 for the PE component of GXXX5. We proposed to assign a malpractice RVU of 0.01. Because the services described by GXXX5 are solely furnished by a CORF social worker or clinical psychologist, and not by a physician, we did not propose to allocate a work RVU for these services.

We also proposed to revise Sec. 410.100(h) to delete the reference to ``and treatment.'' As discussed above and in the CY 2008 PFS final rule with comment period (72 FR 66297), we believe all CORF services, including social and psychological services, must directly relate to or further the rehabilitation goals established in the physical therapy, occupational therapy, speech-language pathology, or respiratory therapy plan of treatment. Accordingly, social and psychological CORF services do not include clinical treatment of mental, psychoneurotic, and personality disorders. We stated that we are concerned that the phrase

``and treatment'' currently included in the definition of CORF social and psychological services may be

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misconstrued to include social and psychological services for the independent clinical treatment of mental illness. Therefore, we proposed to delete this language in order to clarify that only those social and psychological services that relate directly to a rehabilitation plan of treatment and the associated rehabilitation goals are considered CORF social and psychological services.

In addition, we proposed to remove Sec. 410.155(b)(1)(ii) regarding the application of mental health limitations to CORF social and psychological services. As we previously stated, CORF services, including social and psychological services, must directly relate to or further the rehabilitation goals established in the physical therapy, occupational therapy, speech-language pathology, or respiratory therapy plan of treatment. In the CY 2008 PFS final rule with comment period

(72 FR 66400), we stated that CORF services must be furnished under a written plan of treatment that indicates the diagnosis and rehabilitation goals, and prescribes the type, amount, frequency, and duration of the skilled rehabilitation services, including physical therapy, occupational therapy, speech-language pathology and respiratory therapy services. Section 410.155(b) specifies that the mental health payment limitation applies when there is a diagnosis of mental, psychoneurotic, and personality disorders (mental disorders identified by a diagnosis code within the range of 290 through 319) prior to beginning services. Under our revised definition, CORF social and psychological services must directly relate to the physical therapy or other rehabilitation plan of treatment and its associated goals.

Since these patients are receiving CORF services because they have a need for skilled rehabilitation services, any social and psychological services provided in a CORF under Sec. 410.100(h) must include an assessment of the individual's mental and emotional functioning exclusively as such functioning relates to their rehabilitation plan of treatment. In our view, such services provided in a CORF would not be

``treatment of mental, psychoneurotic, and personality disorders of an individual'' as set out in section 1833(c) of the Act, so that the statutory mental health payment limitations would not apply. We proposed changes to Sec. 410.155(b) to reflect our view regarding the limited nature of these services.

The following is a summary of the comments received concerning our proposal to create a HCPCS G-code to describe the unique CORF social and psychological services and our responses.

Comment: One commenter stated that the G-code is more specific to rehabilitation services and its implementation will support future adoption as a CPT code. Another commenter stated that occupational therapy services are a core CORF service. The commenter requested that

CMS clarify that the new G-code would not have a negative impact on the provision of occupational therapy services to meet patient needs that are similar to those addressed by the G-code. The commenter stated that occupational therapy, as with all therapy services, includes assessment of the patient level of functioning as an integral part of the therapy services. Other commenters suggested that therapists and psychologists assess and treat mental, cognitive, and emotional functioning as they relate to a patient's rehabilitation plan of care. The commenters further suggested that CMS revisit its decision not to allow CORF therapists and psychologist to bill the Health and Behavioral

Assessment/Intervention codes (CPT codes 96150 through 96155), which are used to identify and treat ``biopsycholosocial factors important to physical health problems.'' One commenter also requested that the new

G-code include physician work in the RVUs since all other codes billed by psychologist include physician work. Another commenter stated that the statute clearly defines social and psychological services so there is no need for the development of a G-code.

Response: Section 1861(cc)(2)(B) of the Act defines the term CORF to mean a facility which provides at least physician services (as defined at Sec. 410.100(a)), physical therapy services and social or psychological services. As such, occupational therapy services are not considered one of the core CORF services but are optional. The CORF must provide the core CORF services. In addition it may furnish any of the optional covered and medically necessary services and items such as occupational therapy, speech-language pathology, or respiratory therapy services. These optional services must directly relate to, and be consistent with, the rehabilitation plan of treatment, and must be necessary to achieve the rehabilitation goals. Occupational therapy services include assessment of an individual's level of independent functioning, selection and teaching of task-oriented therapeutic activities to restore sensory-integrative functions, teaching of compensatory techniques to permit an individual with a physical or cognitive impairment or limitation to engage in daily activities. The patient's plan of treatment will document all the covered and medically necessary items and services that the patient requires which will include the core CORF services as well as any of the optional services such as occupational therapy.

In the CY 2007 PFS final rule with comment period, we revised Sec. 410.100(h) states that CORF social and psychological services include the assessment and treatment of a CORF patient's mental health and emotional functioning and the patient's response to/and rate of improvement and progress towards the rehabilitation plan of treatment.

In our view, social and psychological services must contribute to the improvement of the individual's rehabilitation condition and may not relate to a mental health diagnoses. In the CY 2008 PFS final rule (72

FR 66298), we discussed the use of CPT codes 96150 through 96155 for health and behavior assessment and treatment, which represent full- scale clinical treatment of mental, psychoneurotic, personality disorders and biopsychosocial functioning. We revised the previous definition of CORF social and psychological services and instructed that these services should be limited to those described by CPT code 96152. We stated that provision of other therapeutic services was outside of the scope of coverage for CORFs. Since these CPT codes were not a part of the proposed regulation, we will not revisit the use of these CPT codes in this final regulation.

We are finalizing our proposal to create the CORF specific G-code which will be G0409. The description of this G-code will be G0409,

Social work and psychological services. This code will directly relate to and/or further the patient's rehabilitation goals, each 15 minutes, face-to face; individual (services provided by a CORF-qualified social worker or psychologist in a CORF), to accurately describe the unique social and psychological services provided by CORF staff and to establish appropriate payment for these services. The code does not include any physician work RVUs because the social and psychological services are performed by a CORF social worker with a Bachelor of

Science degree or a Masters-level psychologist and not by a physician as defined in the statute at section 1861(r) of the Act.

We did not receive any comments on our proposal to eliminate the mental health limitation requirement. The mental health limitation is no longer

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applicable because under our revised definition, CORF social and psychological services must directly relate to the physical therapy or other rehabilitation plan of treatment and its associated goals and do not relate to a general diagnosis of mental, psychoneurotic, and personality disorders which the mental health limitation addresses.

Therefore, we are finalizing our proposed change to remove Sec. 410.155(b)(1)(ii) regarding the application of mental health limitations to CORD social and psychological services. 3. CORF Conditions of Participation

In the CY 2008 final rule with comment period (72 FR 66400), we finalized changes to the CORF coverage and payment rules. However, all conforming regulations in the CORF Conditions of Participation (CoPs) were not updated at that time.

In the CY 2009 PFS proposed rule, we proposed to revise Sec. 485.58(e)(2). Section 485.58(e) currently provides that as a CoP, a

CORF facility must provide all CORF services on its premises with the exception of--(1) physical therapy, occupational therapy, and speech- language pathology services furnished away from the premises of the

CORF, if Medicare payment is not otherwise made for these services; and

(2) a single home visit for the purpose of evaluating the potential impact of the patient's home environment on the rehabilitation goals.

We proposed to clarify that the alternate premises for provision of physical therapy, occupational therapy, and speech-language pathology services may be the patient's home.

The following is a summary of the comments received concerning CORF

CoPs and our responses.

Comment: Commenters concurred with the proposed clarification regarding the patient's home as an alternate premise for provision of physical therapy, occupational therapy, and speech-language pathology services.

Response: We thank the commenters for their support of this provision. As a result of the public comments, we are finalizing the revisions to Sec. 485.58(e)(2) as proposed. 4. Extension Location

We proposed to add a definition for an ``extension location'' of a rehabilitation agency to the definitions at Sec. 485.703. While there are currently no provisions that allow rehabilitation agencies to offer services in an extension location, there are currently 2,875 rehabilitation agency primary locations and 2,486 rehabilitation agency offsite practice locations. While our State Operations Manual recognizes that these rehabilitation agency extension locations exist, it also includes language stating that the extension locations must meet applicable rehabilitation agency CoPs. However, it is difficult to apply CoP requirements to a location that currently is not identified in the CoPs. Creating a definition in the CoPs that applies to the extension locations will allow us to survey and monitor the care provided in these extension locations on a consistent basis.

Therefore, we proposed to define an ``extension location'' as: (1)

A location or site from which a rehabilitation agency provides services within a portion of the total geographic area served by the primary site; (2) is part of the rehabilitation agency; and (3) is located sufficiently close to share administration, supervision, and services in a manner that renders it unnecessary for the extension location to independently meet the conditions of participation as a rehabilitation agency.

The following is a summary of the comments received concerning an extension location and our responses.

Comment: Some commenters supported our proposed revisions and suggested that we add additional clarifying information. One commenter suggested that we clarify the status of space that a rehabilitation agency may use within another facility (for example, a room used by the agency within a nursing facility). Another commenter suggested that we specify a mile radius from the rehabilitation agency's primary site within which an extension location may exist.

Response: We thank the commenters for their input. Regarding a mile radius, mileage, and travel times from the primary location to the extension location are significant factors to consider because they are implicitly referenced in the proposed regulation. However, each alone would not be the single issue in determining appropriateness as a sole means for approving an extension location. We have decided to leave it to the rehabilitation agency to prove to the State survey agency that the rehabilitation agency is close enough to the extension location to provide supervision of staff during its hours of operation. Supervision of the extension location staff must be adequate to support the care needs of the patients. We believe that our proposed definition for an extension location is adequate, as it has been used successfully in our

State Operations Manual for other provider types. We are not making any changes to our proposed revisions based on public comments, and are finalizing them as proposed. 5. Emergency Care

We proposed to revise Sec. 485.711(c), Standard: Emergency care, to reflect current medical practice. We proposed to remove the requirement that the rehabilitation agency provide for one or more doctors of medicine or osteopathy to be available on call to furnish necessary medical care in case of an emergency. We do not believe that the patients serviced by rehabilitation agencies regularly experience medical emergencies that necessitate the retention of an on-call physician.

Therefore, we proposed that each rehabilitation agency establish procedures to be followed by personnel in an emergency that cover immediate care of the patient, persons to be notified, and reports to be prepared.

The following is a summary of the comments received concerning

Emergency care and our responses.

Comment: Most commenters concurred with our proposed changes to the emergency care standard. Specifically, the commenters supported our proposed elimination of the requirement that rehabilitation agencies retain a physician on call for emergencies. The commenters cited difficulty in recruiting physicians for this role, and stated that it is often impractical to contact a physician in the rare case of an emergency. One commenter also supported the revisions to the emergency provisions because they allow facilities to develop emergency care plans most appropriate for an individual facility's location and patient population.

Response: We thank the commenters for their support, and agree that these revisions will allow facilities to plan for, and respond to, emergency care situations in appropriate ways. As a result of the public comments, we are finalizing the provision as proposed with slight non-policy revisions for grammatical purposes. We are also revising the stem statement to remove the reference to the physician's presence in emergency situations. 6. Technical Changes for Rehabilitation Agencies

Under section 1861(p) of the Act, rehabilitation agencies are tasked with furnishing outpatient physical therapy and speech-language pathology services. Unlike CORFs, which provide comprehensive outpatient rehabilitation services, rehabilitation agencies primarily provide physical therapy services. Some of the other services

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offered by CORFs, such as respiratory therapy and social services are outside the scope of rehabilitation agency practice.

The current definition of ``rehabilitation agency'' at Sec. 485.703 (paragraph (2)(ii) of the definition) requires that rehabilitation agencies provide social or vocational adjustment services. This requirement is outside of the rehabilitation agency's scope of practice and has caused confusion for these providers because we do not reimburse rehabilitation agencies for furnishing social or vocational services. Accordingly, in Sec. 485.703, we proposed to delete the requirement in paragraph (2)(ii) of the rehabilitation agency definition requiring a rehabilitation agency provide social or vocational services.

The following is a summary of the comments received concerning the technical change and our responses.

Comment: Most commenters responded in support of this proposed revision. Some commenters stated that this requirement, which is an unfunded mandate, is burdensome, and that patients often resent being required to release their personal information to a social worker they will likely never meet or work with. The commenters also agreed that social and vocational services are outside the scope of practice for rehabilitation agencies.

Response: We thank the commenters for their support of this change.

As a result of the public comments, we are finalizing the provision as proposed.

We also proposed to make a conforming change at Sec. 485.717, the

Condition of participation: Rehabilitation program. At 485.711(b)(3), we proposed to remove the reference to Sec. 410.61(e), since Sec. 410.61(e) no longer exists in regulation.

The following is a summary of the comments received concerning this technical change and our responses.

Comment: Some commenters concurred with this conforming change while others objected to this conforming change because the commenters believe that we did not also address the statement in Sec. 485.711(b)(3) that states that the patient plan of care must be reviewed by a physician, nurse practitioner, clinical nurse specialist, or physician assistant at least every 30 days. The commenters believe that this conflicts with CMS payment policy, which requires recertification of the plan of care at least every 90 days. We also received several unsolicited comments requesting that we correct this perceived discrepancy.

Response: We did not propose to revise the language to conform to changes in the timing for recertification of outpatient therapy plans of care as discussed in the CY 2008 PFS final rule with comment period

(72 FR 66396). Currently, Sec. 485.711(b)(3) requires that the plan of care and results of treatment be reviewed by the physician or by the individual who established the plan at least as often as the patient's condition requires, and the indicated action is taken, which for

Medicare patients being treated in rehabilitation agencies must be at least every 30 days. We believe that this requirement is in the best interests of rehabilitation agency patients, and note that by meeting this condition of participation, facilities would automatically meet the CMS payment policy requiring review at least every 90 days.

We are not making any changes to our proposed revisions as a result of public comments, and are finalizing the conforming change as proposed.

M. Technical Corrections for Therapy-Related Issues

We proposed the following technical changes to the regulations concerning therapy services:

In Sec. 409.17(a), we proposed to delete the reference to paragraph (a)(1)(ii) which no longer exists.

In Sec. 409.23, we proposed to revise the title of this section from ``Physical, occupational and speech therapy'' to

``Physical therapy, occupational therapy and speech-language pathology services.''

Commenters voiced no objections to these technical corrections, and we are finalizing these technical corrections as proposed.

Several commenters brought to our attention changes made to the text of a regulation in the CY 2008 PFS final rule with comment period that did not reflect our policy as expressed in the preamble discussion. We intended to modify our regulations to make the policies for therapy services consistent across all settings. We added Sec. 485.635(e) for the purpose of conforming the policies for physical therapy, occupational therapy and speech-language pathology in the critical access hospitals (CAHs) to the policies for therapy services in Sec. 409.17. Section 485.635(e) describes therapy services when furnished at the CAH as those that ``are provided as direct services by staff qualified under State law, and consistent with the requirements for therapy services described in Sec. 409.17.'' The reference in the regulation to ``direct services'' was not intended to address the employment status of staff providing those services, but we now recognize that it could be interpreted as such. Therefore, we are making a technical correction to the regulatory language at Sec. 485.635(e) to remove the words ``as direct services.''

N. Physician Self-Referral and Anti-Markup Issues 1. Exception for Incentive Payment and Shared Savings Programs (Sec. 411.357(x)) a. Introduction

In the CY 2009 PFS proposed rule (73 FR 38502), we proposed a new exception to the physician self-referral law for incentive payment and shared savings programs. The proposed exception covered various types of hospital-sponsored pay-for-performance (P4P), shared savings (for example, gainsharing), and similarly-styled programs that offer financial incentives to physicians intended to foster high quality, cost-effective care. The exception, as proposed, would provide more flexibility than existing physician self-referral exceptions available for such programs (73 FR 38548).

When establishing a new exception to the physician self-referral law, we rely on the authority granted to us in section 1877(b)(4) of the Act, which mandates that financial relationships permitted under an exception, such as the types of compensation arrangements contemplated by the proposed exception, not pose a risk of program or patient abuse.

As described more fully in the CY 2009 PFS proposed rule, in order to ensure that we did not exceed this authority, the proposed exception was targeted and relatively narrow. We acknowledged that it was unlikely to cover as many arrangements as interested stakeholders would like, and sought comments on ways that we might expand the proposed exception without a risk of program or patient abuse.

We received approximately 55 timely public comment letters regarding the proposed exception for incentive payment and shared savings programs. The majority of commenters supported the establishment of the following: (1) An exception for incentive payment and shared savings programs; or (2) two exceptions--one for incentive payment programs and one for shared savings programs. However, most of these commenters urged us to finalize such an exception or exceptions only if substantial modifications were made to the conditions proposed.

We also received a number of comment letters urging us not to finalize an exception for incentive payment and shared savings programs, some of which asserted that

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we lack statutory authority to do so and contended that any such exception necessarily would pose a risk of program or patient abuse.

As we stated in the CY 2009 PFS proposed rule (73 FR 38548):

In reviewing various programs and industry suggestions, we have been struck by the considerable variety and complexity of existing arrangements, and the likelihood of continued future innovation in the structure and method of these programs. This variety and complexity make it difficult to craft a ``one-size-fits-all'' set of conditions that are sufficiently ``bright line'' to facilitate compliance and enforceability, yet sufficiently flexible to permit innovation without undue risk of program or patient abuse.

Our goal in establishing an exception or exceptions for incentive payment and shared savings programs is ``to promulgate an exception that is as broad as possible'' yet consistent with the statutory requirement that any arrangement excepted under an exception issued using our authority in section 1877(b)(4) of the Act pose no risk of program or patient abuse (73 FR 38548). Although we received thoughtful and instructive comments, we did not receive through the initial public comment process sufficient information or agreement among commenters regarding possible modifications to the proposal to allow us to finalize an exception that expands the proposed exception in any meaningful way. Therefore, we are reopening the public comment period to obtain the specific information described below. We believe that, if ultimately provided through the extended public comment process, the additional information we are requesting will assist us in finalizing an exception or exceptions for incentive payment and shared savings programs. The comment period will be reopened for an additional 90 days following publication of this final rule with comment period in the

Federal Register. Information regarding the submission of public comments can be found in the ADDRESSES section of this final rule with comment period. We will summarize and respond to all comments received in response to our proposal (or any future proposal for an exception

(or exceptions) to the physician self-referral law for incentive payment and shared savings programs), including the 55 comment letters noted above, in a final rulemaking.

For ease of reference, we are numbering our solicitations of comments in a continuous sequential order, and we encourage commenters to refer to these numbers in their submissions to us. Although we have offered many specific solicitations of comments in an effort to stimulate and focus discussion, we do not mean to imply that we are interested in receiving comments only on the specific questions noted below; rather, we encourage comments on any and all relevant issues to an exception or exceptions for incentive payment and shared savings programs. In addition, we request that commenters consider all of the issues in context and in conjunction with each other, as well as consider the exception holistically rather than piecemeal. Many of the specific solicitations below are related to each other and may be better addressed if grouped together.

We urge commenters to respond with specificity and to include detailed, practical examples whenever possible. Commenters are encouraged to consider the requirement under section 1877(b)(4) of the

Act that any new regulatory exception pose no risk of program or patient abuse. Although the following discussion segregates individual issues, commenters are encouraged to comment on and recommend combinations of conditions for an exception or exceptions that would meet the ``no risk'' standard, would be sufficiently bright line to be enforceable and to facilitate compliance, and would be sufficiently flexible to foster beneficiary arrangements. Commenters should consider suggesting alternative safeguards when recommending the elimination or modification of a proposed condition or when recommending adoption of an alternative to a proposed condition. As an initial matter, we are interested in comments that address the best ways in an exception or exceptions for incentive payment or shared savings programs to achieve transparency and accountability, ensure quality of care, and prevent disguised payments for referrals. We request that commenters address these goals in their comments.

To better understand and address the variety of incentive payment and shared savings programs that exist in the industry or that parties would like to implement, we are interested in detailed descriptions of incentive payment programs and shared savings programs that include specific descriptions of the structure and operations of the programs and payments. We are also interested in views addressing the likely evolution of these programs. b. Background: Incentive Payment and Shared Savings Programs

As we discussed in both the CY 2009 PFS proposed rule, and the FY 2009 IPPS proposed rule, the term ``gainsharing'' is commonly used to describe certain programs that seek to align physician behavior with the goals of a hospital by rewarding physicians for reaching predetermined performance outcomes. Several types of programs exist

(including, but not limited to, gainsharing) for the purpose of achieving quality standards, generating cost savings, and reducing waste. We refer to these programs as ``incentive payment'' and ``shared savings'' programs. Within the category of ``incentive payment'' programs, we include P4P, also known as quality-based purchasing, and other quality-focused programs that do not involve the sharing of cost savings from the reduction of waste or changes in administrative or clinical practice. Within the category of ``shared savings'' programs, we include programs that involve the sharing of cost savings attributable to physicians' efforts in controlling the costs of providing patient care, as well as hybrid programs that involve both the sharing of cost savings and payment for improvement or maintenance of patient care quality. For a discussion of incentive payment and shared savings programs, DHHS initiatives with respect to such programs, and our proposed exception for incentive payment and shared savings programs, we refer the reader to our solicitation of comments in the FY 2009 IPPS proposed rule regarding the necessity of an exception to the physician self-referral law for gainsharing programs

(73 FR 23692 through 23695) and the CY 2009 PFS proposed rule (73 FR 38548 through 38552).

In the CY 2009 PFS proposed rule, we described our concerns regarding potential program and patient abuse from the implementation of improperly structured incentive payment and shared savings programs.

Specifically, we stated:

Although properly structured incentive payment programs can enhance health care quality and efficiency, improperly structured programs pose significant risks of program or patient abuse, including adversely affecting patient care. Moreover, such programs could be vehicles to disguise payments for referrals, including incentives to steer healthier patients to the hospital offering the incentive payment program. Programs that cannot be adequately and accurately measured for quality would also pose a high risk of program or patient abuse (73 FR 38549).

We stated further:

Although properly structured shared savings programs may increase efficiency and reduce waste, thereby potentially increasing a hospital's profitability and contributing to

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quality of care, improperly designed or implemented programs pose the same risks of program or patient abuse described above in connection with incentive payment programs. Additional risk is posed by shared savings programs that reward physicians based on overall cost savings (for example, the amount by which the total costs attributable to a particular hospital department decreased from 1 year to the next) without accountability for specific cost reduction measures (73 FR 38550).

In addition, we expressed our continued concern about stinting

(limiting the use of quality-improving but more costly devices, tests or treatments), cherry-picking (treating only healthier patients as part of an incentive payment or shared savings program), steering

(avoiding sicker patients at the hospital sponsoring the incentive payment or shared savings program), and quicker-sicker discharges

(discharging patients earlier than clinically indicated either to home or to post-acute care settings). c. Solicitation of Additional Public Comments i. Distinguishing between ``incentive payment'' and ``shared savings programs''

In the CY 2009 PFS proposed rule, we sought comments regarding

``whether separate exceptions for incentive payment and shared savings programs would be preferable and, if so, how they should be structured, and which requirements should appear in each'' (73 FR 38552). Most commenters in support of establishing an exception for incentive payment and shared savings programs recommended that we establish two separate exceptions. Here, we are requesting specific comments regarding how [1] to define the terms ``incentive payment program'' and

``shared savings program.'' We also request comments regarding [2] whether the terminology ``incentive payment'' and ``shared savings'' programs is appropriate or whether different terminology would better describe the range of nonabusive programs we intend to cover under the proposed exception(s). Whatever terminology we employ, we must define the terms with sufficient clarity to enable parties to determine which exception, if more than one is finalized, would be applicable to the specific arrangement being analyzed.

Commenters in support of the adoption of two separate exceptions frequently asserted that many of the conditions in the proposed exception are not applicable, or need not be applicable, to incentive payment programs, asserting that incentive payment programs do not pose the same risk of program or patient abuse as traditional gainsharing programs or shared savings programs. We are seeking comments that [3] identify with specificity which conditions should be made applicable to incentive payment programs (and why), [4] identify which conditions need not or should not be made applicable to incentive payment programs

(and why), and [5] indicate why it would not be necessary to impose the same safeguards against program or patient abuse on both types of programs. For example, we seek comments on [6] whether a program involving cost savings measures that also improve quality should be treated as an incentive payment or shared savings program. ii. Risk of Program or Patient Abuse

As noted above, several commenters questioned our ability to promulgate an exception for shared savings programs that satisfies the mandate under section 1877(b)(4) of the Act that any exception issued using that authority pose no risk of program or patient abuse. The commenters asserted that, because gainsharing implicates sections 1128A(b)(1) and (b)(2) of the Act, commonly referred to as the Civil

Monetary Penalty (CMP) statute, any exception to the physician self- referral law for incentive payment and shared savings programs would necessarily pose a risk of program or patient abuse and would be outside the scope of our authority under section 1877(b)(4) of the Act.

We disagree with these commenters. We believe that it is possible within the meaning of section 1877(b)(4) of the Act to establish a set of safeguards to guard against program and patient abuse. Moreover, it is our understanding that many incentive payment programs would not involve payments to physicians to reduce or limit services to hospital patients. However, we are interested in comments that [7] specifically address this issue in greater detail, including [8] how we can satisfy the requirements of section 1877(b)(4) of the Act if we do not include a condition prohibiting payment to a physician (under the incentive payment or shared savings program) for reducing or limiting items or services furnished to Medicare or Medicaid beneficiaries under the physician's direct care. In addition, we are interested in comments regarding [9] the utility of an exception that incorporates conditions that are the same as or similar to conditions that have appeared in favorable advisory opinions issued by the OIG on gainsharing arrangements. iii. Design of the Program

In the CY 2009 PFS proposed rule, we proposed protecting documented programs that seek to achieve the improvement of quality of hospital patient care services through changes in physician clinical or administrative practices or actual cost savings for the hospital resulting from the reduction of waste or changes in physician clinical or administrative practices (73 FR 38553). To be protected, the program must achieve one or both of these goals without an adverse effect on, or diminution in, the quality of hospital patient care services.

(1) Objective Medical Evidence and Independent Review

Under the proposed exception, incentive payment and shared savings programs must be supported by objective, independent medical evidence indicating that the applicable cost-savings or quality performance measures would not adversely affect patient care. We also proposed that patient care quality measures must derive from CMS' Specifications

Manual for National Hospital Quality Measures. Many commenters objected to this limitation; however, the comments, for the most part, did not contain suggestions regarding other appropriate lists of quality measures or whether (and in what manner or under what circumstances) we should permit parties to establish their own quality measures for inclusion in a protected incentive payment or shared savings program.

We are seeking comments on this issue, including [10] how we might avoid protecting payments based on sham measures or measures that do not reflect objective quality outcomes or standards but instead may be vehicles to reward referrals.

We proposed in the CY 2009 PFS proposed rule that an incentive payment or shared savings program must be reviewed prior to implementation of the program and at least annually thereafter to ascertain the program's impact on the quality of patient care services provided by the hospital. We proposed that this review must be performed by an independent medical reviewer; that is, the review must be conducted by a person or organization with relevant clinical expertise that is not affiliated with the hospital operating the program under review and not affiliated with any physician participating in the program or with any physician organization with which a participating physician is affiliated. We also proposed that the reviewer could not be participating (at the time of the review) in any incentive

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payment or shared savings program operated by the hospital (73 FR 38553 through 38554). A substantial number of commenters objected to the requirement of independent medical review, claiming that the expense of independent medical review would likely be significant, and that many hospitals may not be able to find an ``independent'' medical reviewer.

Commenters also contended that the impact on patient care can best be ascertained through individuals associated with the hospital, because hospital personnel and medical staff physicians are intimately aware of hospital operations and patient populations.

We seek comments on [11] whether, assuming that there is a need for independent medical review, the need would be greater if the exception were to include outcome measures that are not on the CMS-approved list.

We also seek comments on an alternative to independent medical review that would provide an objective, accurate and complete review.

Specifically, we request comments addressing [12] how, if no independent medical review is required, we could ensure that a hospital is objective in the review of its incentive payment and shared savings program, that programs operate appropriately to improve (or maintain) patient care quality, and that the incentive payment or shared savings program results in no diminution of patient care quality or inappropriate reduction in care. Finally, and irrespective of whether we would require independent medical review or permit ``in-house'' review, we seek comments on: [13] How, when and what type of (for example, further review, corrective action, or termination of the incentive payment or shared savings program) recommendations should be made by the reviewer when the program review identifies concerns with patient care quality or the diminution in patient care quality resulting from the implementation of the incentive payment or shared savings program; and [14] requirements (including timeframes) for the hospital to take corrective action based on the reviewer's recommendations.

(2) Participating Physicians and Payment Amounts

The proposed exception included a requirement that the incentive payment or shared savings program be structured to require physician participation in the program in pools of five or more physicians, with payments being distributed to members of each pool on a per capita basis. Under the proposed exception, all physicians participating in the program must be on the medical staff of the sponsoring hospital at the commencement of the program. Most commenters objected to these requirements, but did not provide clear suggestions regarding how to address our concern regarding disguised payments that reward referrals or other business generated by the physician in the absence of such structural requirements. Therefore, we are seeking specific comments on alternatives to these participation and payment restrictions, as well as other safeguards that we could include in an exception(s) if we were to omit the ``five-physician pool,'' per capita payment distribution, and/or medical staff membership requirements. We request comments as to

whether, if pools of less than five physicians are permitted, what the minimum number of physicians should be; [16] whether all participating physicians must be in the same specialty, and, if not, what issues are raised by protecting arrangements between hospitals and multi-specialty physician groups; [17] whether participating physicians should be required to be on the medical staff at the hospital at the commencement of the program and, if not, how we should address the risk that programs will be used inappropriately as recruiting tools; and

whether medical staff members may be added during an ongoing program and, if so, how we should address the risk that payments would be made to recruit physicians from other area hospitals, especially hospitals that might not be able to afford to offer a similar program.

We also seek comments with respect to limitations on payments under an incentive payment or shared savings program. Specifically, we are interested in comments regarding whether: [19] We should impose a cap on the payment made per participating physician, regardless of the amount of cost savings or achievement of patient care quality goals attributable to a particular physician; [20] whether payments should be limited in duration and, if so, whether 3 years or some other period should be the maximum time period for payments; and [21] whether protected payments should be reasonably related to the measure that is achieved and, if so, how a reasonable relationship should be determined, and, if not, how we could protect against excessive payments that might induce referrals. In this regard, we are interested in comments addressing [22] methods for protecting against excessive payments to referring physicians who participate in the program but may contribute little or no work or expertise to the program. We are further interested in comments on [23] the types of physicians who should be protected participants and what it should mean to be a

``participating'' physician. Finally, we are interested in comments addressing [24] the concept of restricting physicians from receiving payments for previously achieved cost savings or for meeting quality improvement goals that are, or have become over time, standard practice

(for example, we are concerned about payments that amount to little more than supplemental payments to physicians to do nothing more than what they are already doing) (73 FR 38555 through 38556).

In the CY 2009 PFS proposed rule, as described above, we proposed that payments to physicians be made (whether directly to the physician or to his or her qualifying physician organization) on a per capita basis. We also solicited comments that would ``outline alternate approaches to the per capita payment model for the distribution of incentive payments or shared savings payments, such as paying a physician more or less according to whether he or she contributed more or less to the achievement of the performance measures'' included in the program (73 FR 38555). Although many commenters stated support for permitting payments to physicians that directly correlate to their personal efforts and achievement of performance measures in an incentive payment or shared savings program, few comments provided sufficient detail regarding how we could incorporate this expansion into the exception without risk of program or patient abuse. We are interested in comments that [25] outline with specificity how a hospital would track or otherwise determine the ``personal efforts'' of a physician and correlate the achievement of performance measures to a particular physician's personal efforts and, in turn, to the amount of the payment.

We also proposed a condition that would prevent physicians from being paid in a manner that reflected increased volumes of Federal health care program patients or services. Commenters generally opposed this proposed restriction. We recognize as we stated in the CY 2009 PFS proposed rule that volume changes can occur due to market forces and physician practice growth, rather than from changes in referral patterns due to financial incentives available to physicians participating in an incentive payment or shared savings program (73 FR 38555). Where changes in the volume of Federal

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health care patients or services occur because of financial incentives, a risk of abuse exists. We are soliciting comments that [26] specifically address how to account for legitimate fluctuations in the volume of Federal health care patient procedures or services and consider the potential that volume increases can indicate altered referral patterns when a physician is participating in an incentive payment or shared savings program. In addition, we are seeking comments regarding [27] possible ways to ensure against increases in total

Medicare expenditures for patients for whom services are provided under an incentive payment or shared savings program.

We proposed to require hospitals to make payments directly to participating physicians or to a ``qualified physician organization,'' which we proposed to define as a physician organization composed entirely of physicians participating in the incentive payment or shared savings program (73 FR 38553). We sought comments regarding possible expansion of this condition to allow payments to a physician organization even if all of its affiliated physicians were not participating in the incentive payment or shared savings program under which the payment is made. We reiterate our concern that payments made to physician organizations with nonparticipating physicians could be used to reward such nonparticipating physicians for their referrals.

Many commenters objected to the strict limitations on the parties to whom a hospital may make a payment under an incentive payment or shared savings program. Commenters generally urged greater flexibility in the distribution of payments. We are seeking here specific information regarding [28] conditions that could be imposed to ensure no risk of program or patient abuse including, for example, conditions on the use and distribution of payments made to physician organizations on behalf of participating physicians.

(3) Costs Savings for Shared Savings Programs

With respect to shared savings programs, we proposed various methods and sought comments on other methods for limiting or capping the total amount of cost savings available under the program. We proposed a flat, 50 percent limit on the amount of cost savings eligible for sharing with participating physicians, and also proposed requiring rebasing of the baseline statistics against which reduction in waste and cost savings would be measured. In the alternative, we proposed a surrogate method of capping total available payments that would be actuarially equivalent to a 50 percent cap with annual rebasing of baseline statistics. Many commenters responded that we should impose no limits on how a hospital determines the amount available for shared savings payments, while other commenters objected to the 50 percent cap and/or the rebasing requirement. As we noted in the CY 2009 PFS proposed rule and above, our goal is to finalize an exception (or exceptions) that provide sufficient flexibility for hospitals to structure and implement a variety of nonabusive incentive payment and shared savings programs. We are seeking comments that specifically address: [29] What safeguards we could include in an exception if we do not include a cap on the total amount of cost savings available for distribution to participating physicians; [30]

What safeguards we could include in an exception to ensure that physicians are not paid for achieving performance measures they achieved in prior periods of the program if we do not require rebasing of the baseline against which reductions in waste or costs are measures; [31] whether it is appropriate to permit payments for continued achievement (or maintenance) of performance measures, waste reduction or cost savings and, if so, what safeguards we could include in an exception if we were to do so (for example, reduced payments for maintenance of patient care quality compared with payments for the achievement of targets); and [32] whether the answer to [33] differs for incentive payment programs as opposed to shared savings programs.

We have had limited opportunity to review incentive payment and shared programs for compliance with the physician self-referral law, and we lack familiarity with the specifics of measuring achievements and calculating payments under such programs. We received insufficient information in the public comments to set forth with enough specificity conditions regarding the calculation of cost savings so as to enable parties to evaluate compliance with the exception. We proposed to require that payments that result from cost savings be calculated based on acquisition costs for the items at issue, as well as the costs involved in providing the specified services, and that they be calculated on the basis of all patients, regardless of insurance coverage (73 FR 38556). Many commenters stated that the term

``acquisition costs'' was unclear or that it is difficult to determine the actual costs involved in providing specified services, and suggested that we provide additional guidance regarding these concepts if we were to finalize this condition on payments. We are seeking additional and specific comments regarding [34] the calculation of the amount of total cost savings available for distribution under a shared savings program, including a discussion of formulae used by parties to existing arrangements.

(4) Protecting Quality of Care

We proposed that, under an exception for incentive payment and shared savings programs, no payments could be made if the program resulted in a diminution of patient care quality. Additional issues were raised in the public comments, and we seek further comments on the following: [35] Whether and, if so, how we should address the situation in which the implementation of an incentive payment or shared savings program results in a diminution in patient care quality measures not included in the incentive payment or shared savings program; [36] whether we should permit payments based on the global improvement in patient care quality instead of individually identified and tracked patient care quality measures; [37] if a program is structured to result in payments when global quality improves, whether and, if so, how should we permit payments to be made if only some of the quality measures are met; [38] whether payments should be permitted for the maintenance of patient care quality (as opposed to the improvement of patient care quality) [39] whether payments should be permitted for the achievement of intermediate targets for patient care quality and how intermediate targets should be defined and measured; [40] what types of medical evidence should support quality measures, and how we can ensure that quality measures are supported by credible medical evidence; and

whether measures must have some relation to the patient populations and practices at the hospital and, if so, what the relation should be, and, if not, how we could protect against programs that are structured to reward physicians for reaching subjective or limited goals that do not substantially benefit the hospital's patients.

We seek additional information on how parties measure patient care quality and determine appropriate payment amounts for the achievement of targets for patient care quality measures. For example, we request comments on: [42] How quality improvement should be

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measured, including how a baseline (that is, starting point) should be set from which to measure the improvement, how recent the baseline should be, and whether the targets should reflect regional data, national data, or some other data; [43] whether we should recognize a difference between ``quality improvement'' and ``quality maintenance'' and, if so, how we should define those terms in relation to each other, whether an exception should protect payments for both, and whether they should be valued differently (based on the supposition that improving quality may require more effort than maintaining it); and [44] how we can prevent protecting payments for programs that are not meeting their quality goals or for measures that, when achieved, result in a diminution of patient care quality. iv. Structure of the Arrangement Between the Hospital Sponsoring the

Program and the Physicians Participating in the Program

(1) Documentation

In the CY 2009 PFS proposed rule, we included in the proposed exception for incentive payment and shared savings programs a requirement that the sponsoring hospital maintain certain documentation regarding the program that must be made available to the Secretary upon request. Many commenters supported this requirement, while others stated that it presented an undue administrative burden. We are seeking comments regarding [45] possible ways to reduce the administrative burden and cost for hospitals that would not hinder the government's ability to enforce the physician self-referral law and ensure compliance with a final exception (or exceptions). We are also seeking additional comments regarding [46] the inclusion of an audit requirement with respect to the calculations of cost savings and payment amounts under the incentive payment or shared savings program.

Many commenters supported such a requirement, and stated that we should permit the audit to be performed ``in-house.'' We are seeking comments here regarding [47] whether such an audit could satisfy our concerns regarding the objectivity and accuracy of the audit. Specifically, we seek comments on [48] whether parties should be required to monitor and track each cost savings or quality measure and, if so, how we should address the need for transparency and accountability.

(2) Sharing of Global Savings

Of particular concern from a fraud and abuse perspective is the sharing of total (or global) savings for a particular department or service line. Many commenters urged us to permit hospitals to share with physicians a percentage or share of the total savings in a particular department or service line, calculated from one period to another. The calculation and sharing of such global savings would not involve individually-tracked and measured performance measures, a cornerstone of the programs that have received favorable advisory opinions from the OIG to date. We seek comments regarding [49] necessary safeguards to ensure that a final exception for shared savings programs, when considered in its totality, would not present a risk of program or patient abuse if we permitted the sharing of departmental or service line global cost savings. In addition, we are interested in [50] the impact that sharing such savings with physicians would have on other potential requirements of a final exception, such as the requirement that the calculation of cost savings and physician payments be audited.

(3) Miscellaneous

We request comments on [51] whether the exception should protect contracts/arrangements between hospitals and physician groups or only contracts/arrangements between hospitals and individual referring physicians (and, if the exception should allow contracts/arrangements between hospitals and physician groups, how we could protect against payments to physicians who do not actively participate in the program and who might be rewarded merely for making referrals). Also, we seek comments on [52] whether, if a physician group participates, the physician group may be paid if some of its physicians fail to make quality improvements; and [53] whether all physicians in the physician group should be required to participate in the same measures. v. Availability of Other Physician Self-Referral Exceptions

We note that there are many exceptions for compensation arrangements in Sec. 411.355 and Sec. 411.357 of our regulations, including exceptions for bona fide employment relationships (Sec. 411.357(c)), personal service arrangements (Sec. 411.357(d)), arrangements involving fair market value compensation (Sec. 411.357(l)), arrangements involving indirect compensation (Sec. 411.357(p)), and services provided by an academic medical center (Sec. 411.355(e)). We believe that properly structured arrangements involving physician participation in an incentive payment or shared savings program may meet the requirements of one or more of the existing physician self-referral exceptions for compensation arrangements. (An arrangement that implicates the physician self-referral statute need not satisfy more than one exception.) We request comments on [54] the extent to which a ``stand-alone'' exception(s) for incentive payment and shared savings programs is necessary given the existence of other compensation exceptions, including the ones mentioned above. We request comments on [55] whether it would preferable for us to modify aspects of the existing exceptions to protect a broader range of beneficial, nonabusive incentive payment and shared savings programs. d. Conclusion

It is evident from the variety of comments that we received and the detailed descriptions from some commenters of existing or ``ideal'' incentive payment or shared savings programs that such programs can be structured in a multitude of ways. Experience with one program model does not ensure an understanding of the impact of another program model. The structures of programs with similar positive outcomes do not necessarily resemble each other.

We intend to continue working toward finalizing an exception (or exceptions) for incentive payment and shared savings programs. We do not believe, as several commenters suggested, that we must or should delay the issuance of a final exception until the completion of the gainsharing demonstrations authorized by section 1866C of the Act and section 5007 of the DRA. (See 73 FR 38550 for a description of these initiatives.) However, without the additional information discussed in this preamble, our efforts to finalize an exception(s) will be hindered. By soliciting additional public comments on the proposed exception for incentive payment and shared savings programs, we hope to acquire information that will better inform the development of an exception that is sufficiently flexible to encourage the development and implementation of beneficial, nonabusive incentive payment and shared savings programs that foster high quality, cost-effective care for our beneficiaries.

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2. Changes to Reassignment Rules Related to Diagnostic Tests (Anti-

Markup Provisions)

Section 1842(n)(1) of the Act requires us to impose a payment limitation on certain diagnostic tests where the physician performing or supervising the test does not share a practice with the physician or other supplier that bills for the test. We implemented section 1842(n)(1) of the Act by applying an ``anti-markup'' payment limitation to technical components (TCs) of diagnostic tests purchased from an outside supplier, which has long appeared in our regulations in Sec. 414.50 and which is applicable to diagnostic tests covered under section 1861(s)(3) of the Act and paid for under 42 CFR part 414 (other than clinical diagnostic laboratory tests paid under section 1833(a)(2)(D) of the Act, which are subject to the special billing rules set forth in section 1833(h)(5)(A) of the Act). In the CY 2008

PFS final rule with comment period (72 FR 66222), relying on section 1842(n)(1) of the Act, our general rulemaking authority under sections 1102(a) and 1871(a) of the Act, and authority under section 1842(b)(6) of the Act, we amended the anti-markup provision in Sec. 414.50.

Specifically, we revised the anti-markup provision to apply to the TC of diagnostic tests that are ordered by the billing physician or other supplier (or ordered by a party related by common ownership or control to such physician or other supplier) when the TC is outright purchased or when the TC is not performed in the ``office of the billing physician or other supplier.'' We revised Sec. 414.50(a)(2)(iii) to define the ``office of the billing physician or other supplier'' as medical office space where the physician or other supplier regularly furnishes patient care. For a billing physician or other supplier that is a physician organization, as defined at Sec. 411.351, the ``office of the billing physician or other supplier'' is space in which the physician organization provides substantially the full range of patient care services that the physician organization provides generally. We also imposed an anti-markup payment limitation on the professional component (PC) of diagnostic tests that are ordered by the billing physician or other supplier (or ordered by a party related by common ownership or control to such physician or other supplier group) if the

PC is outright purchased or if the PC is not performed in the office of the billing physician or other supplier. Under the CY 2008 PFS final rule with comment period, if a physician or other supplier bills for the TC or PC of a diagnostic test that was ordered by the physician or other supplier (or ordered by a party related to such physician or other supplier through common ownership or control) and the diagnostic test is either purchased from an outside supplier or performed at a site other than the office of the billing physician or other supplier, the payment to the billing physician or other supplier (less the applicable deductibles and coinsurance paid by the beneficiary or on behalf of the beneficiary) for the TC or PC of the diagnostic test may not exceed the lowest of the following amounts:

The performing supplier's net charge to the billing physician or other supplier;

The billing physician or other supplier's actual charge; or

The fee schedule amount for the test that would be allowed if the performing supplier billed directly.

In the CY 2009 PFS proposed rule (73 FR 38502), we proposed revisions to the anti-markup provisions in Sec. 414.50, and solicited comments on how best to implement these approaches. We proposed that the anti-markup provisions would apply in all cases where the TC or the

PC of a diagnostic testing service is either: (i) Purchased from an outside supplier; or (ii) performed or supervised by a physician who does not share a practice with the billing physician or other supplier.

We proposed two alternative approaches to determining whether the performing or supervising physician ``shares a practice'' with the billing physician or other supplier. We also solicited comments regarding other possible approaches to address our concerns regarding overutilization that can occur when a physician or physician organization is able to profit from diagnostic testing services not actually performed by or supervised by a physician who ``shares a practice'' with the billing physician or other supplier.

In what we designate here as ``Alternative 1,'' we proposed that a physician who is employed by or contracts with a single physician or physician organization ``shares a practice'' with that physician or physician organization. We stated that, when a physician provides his or her efforts for a single physician organization (whether those efforts are full-time or part-time), he or she has a sufficient nexus with that practice to justify not applying the anti-markup provision as contemplated under section 1842(n)(1) of the Act. In light of this proposal, we also requested comments on how to consider locum tenens and other arrangements under which a physician provides occasional services outside of his or her physician organization, as we recognized that circumstances may exist under which it is beneficial or necessary for a physician to provide diagnostic testing services to more than one physician practice.

We proposed a second alternative proposal, which we designate here as ``Alternative 2,'' which would maintain much of the current regulation text, and its ``site-of-service'' approach to determining whether a physician ``shares a practice'' with the billing physician or other supplier, that was finalized in the CY 2008 PFS final rule with comment period. In other words, we reproposed to apply the anti-markup payment limitation to non-purchased TCs and PCs that are performed outside the office of the billing physician or other supplier. We also solicited comments on whether this is the best anti-markup approach or whether we should employ a different approach.

Specifically, in Alternative 2, we proposed to amend Sec. 414.50 to: (1) Clarify that the ``office of the billing physician or other supplier'' includes space in which diagnostic testing is performed that is located in the same building in which the billing physician or other supplier regularly furnishes patient care (and to make two other revisions to the definition); (2) clarify that, with respect to TCs, the anti-markup provision applies if the TC is either conducted or supervised outside the office of the billing physician or other supplier; (3) clarify when we consider the TC of a diagnostic test to be purchased from an outside supplier; (4) clarify that, for purposes of applying the payment limitation in Sec. 414.50(a)(1)(i) only, with respect to the TC, the ``performing supplier'' is the physician who supervised the TC and, with respect to the PC, the ``performing supplier'' is the physician who performed the PC; and (5) include an exception for diagnostic tests ordered by a physician in a physician organization (as defined at Sec. 411.351) that does not have any owners who have the right to receive profit distributions. Finally, we solicited comments on how to define ``net charge'' and on whether we should delay beyond January 1, 2009, the application of the revisions made by the CY 2008 PFS final rule with comment period, or the proposed revisions (to the extent they are finalized), or both.

We received numerous comments in response to the proposals related to the anti-markup provisions. Some commenters requested that we withdraw both the CY 2008 PFS rulemaking and the current proposals.

Other commenters offered varied

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support or criticism for one or both of the proposed alternatives. Some commenters expressed concerns about eliminating legitimate, nonabusive arrangements that serve Medicare beneficiaries. Quality concerns were raised by commenters both in favor of and opposed to the proposals.

Commenters in support of Alternative 1 believe that it would be more straightforward and easier to implement than Alternative 2. Some commenters responded to Alternative 1 by requesting that a physician be able to ``share a practice'' with up to 3 physicians or physician organizations in order to accommodate arrangements that currently exist among many part-time physicians and the groups for whom they work.

These commenters also stated that they would no longer be able to support an in-office laboratory employing part-time physicians if the

Alternative 1 approach was implemented as proposed.

Some commenters offered support for Alternative 2 and its ``site- of-service'' approach, which they argued would curb abusive overutilization while granting physicians more flexibility in how to structure arrangements to provide care as they see fit. Commenters opposed to Alternative 2 were concerned that this approach focuses only on where the test is performed and not by whom. Some commenters did not support our proposal to clarify ``office of the billing physician or other supplier'' as including diagnostic testing performed in the

``same building,'' but not in a ``centralized building,'' preferring that ``office of the billing physician or other supplier'' also encompass diagnostic testing performed in a ``centralized building.''

Most commenters agreed with our proposed clarification that the TC of a diagnostic test is not ``purchased from an outside supplier'' if the TC is both conducted by the technician and supervised by the physician within the office of the billing physician or other supplier.

We received a few comments, some in favor of and some opposed to, the proposed exception for diagnostic tests ordered by physicians in a physician organization with no owners who have the right to receive profit distributions. Most of the comments that we received in response to the ``net charge'' solicitation expressed dissatisfaction regarding the disallowance of overhead costs in the calculation of the ``net charge.'' Other commenters, however, agreed that these costs should not be included and that only those charges that are incurred from paying the physician providing the PC or supervising the TC should be included.

We received a number of comments addressing issues outside the scope of this rulemaking, in particular, the in-office ancillary services exception to the physician self-referral law, which is codified in Sec. 411.355(b) of our regulations. Commenters believed that we must curtail the types of arrangements currently permitted under the in-office ancillary services exception in order to curb overutilization through the ordering of unnecessary diagnostic tests.

After careful consideration of the comments that we received, we are adopting a flexible approach that incorporates both proposed alternatives. We are finalizing Alternative 1 with some modifications, and retaining with some modifications the present ``site-of-service'' approach (Alternative 2) to allow physicians to consider both approaches in determining if the anti-markup provisions apply to particular diagnostic testing services. Arrangements should be analyzed first under Alternative 1. Thus, where the performing physician (that is, the physician who supervises the TC or performs the PC, or both) performs substantially all (at least 75 percent) of his or her professional services for the billing physician or other supplier, none of the services furnished by the physician on behalf of the billing physician or other supplier will be subject to the anti-markup payment limitation in Sec. 414.50. If the performing physician does not meet the ``substantially all'' services requirement of Alternative 1, an analysis under the Alternative 2 requirements may be applied on a test- by-test basis to determine whether the anti-markup payment limitation applies. Under the Alternative 2 ``site-of-service'' approach, only TCs conducted and supervised in and PCs performed in the office of the billing physician or other supplier by an employee or independent contractor physician will avoid application of the anti-markup payment limitation. Both the ``substantially all professional services'' and

``site-of-service'' tests are measures of whether a performing/ supervising physician ``shares a practice'' with the billing physician or other supplier. With respect to Alternative 2, we believe that restrictions regarding the location of the conducting and supervising of the TC are essential to ensure that, if the test is to be billed as performed by the billing physician or other supplier, the billing physician or other supplier exercise sufficient control and a proper nexus to the individuals conducting and supervising the test. Requiring that the TC be conducted and supervised in the office of the billing physician or other supplier, under Alternative 2, creates this control and nexus. We believe that allowing billing physicians and other suppliers that cannot satisfy Alternative 1 to comply with the requirements of Alternative 2 on a case-by-case basis affords physicians flexibility while addressing our concerns regarding the ordering of unnecessary diagnostic tests.

As we noted above, we have made one modification to Alternative 1 in response to comments we received. Rather than requiring that a physician work exclusively for one physician practice, in order to

``share a practice'' with a particular physician or physician organization, a physician must provide ``substantially all'' of his or her professional services for that practice. For purposes of

Alternative 1, we are defining ``substantially all'' as ``at least 75 percent.'' In this regard we note that ``substantially all,'' as used in certain of our physician self-referral rules, is defined as ``at least 75 percent'' (see Sec. 411.352(d) and Sec. 411.356(c)(1)).

Although the anti-markup provisions in Sec. 414.50 and the physician self-referral rules in Sec. 411.350 through Sec. 411.389 are separate and distinct, we believe that ``at least 75 percent'' is an appropriate test within the context of Alternative 1, and we also wish to avoid any unnecessary confusion that could result from having one numerical test for the anti-markup provisions and another numerical test for the physician self-referral rules. Thus, for purposes of determining whether the anti-markup provisions apply, the performing physician

(that is, the physician supervising the TC or performing the PC, or both) is considered to share a practice with a physician group for which he or she provides at least 75 percent of his or her professional services--even if the physician works for one or more billing physician groups or other health care entities. The final rule provides at revised Sec. 414.50(a)(2)(ii) that the ``substantially all'' requirement is satisfied if the billing physician or other supplier has a reasonable belief at the time it submits a claim that: (1) The performing physician has furnished substantially all of his or professional services through the billing physician or other supplier for the period of 12 months prior to and including the month in which the service was performed; or (2) the performing physician is expected to furnish substantially all of his or her professional services through the billing physician or other supplier during the

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following 12 months (including the month the service is performed).

We believe that our modification to the proposal for Alternative 1 will satisfy the concerns regarding locum tenens arrangements (and part-time and other on-call or similar arrangements), provided that the performing physician is not furnishing more than 25 percent of his or her professional services as a locum tenens physician (or in some other capacity, such as a part-time physician for another billing group or moonlighting at a hospital).

We are also retaining the present site-of-service approach to determining whether a physician ``shares a practice'' with the billing physician or other supplier. This approach was reproposed as

Alternative 2, with a proposed clarification that diagnostic testing performed in the ``same building'' (as defined at Sec. 411.351) in which the ``office of the billing physician or other supplier'' is located would not be subject to the anti-markup provisions (provided that the testing was not purchased from an outside supplier). We are adopting this clarification, but deleting the references to purchased

TCs and PCs from Sec. 414.50, for the reasons explained below. We are also adopting certain proposed clarifications and definitions.

Specifically, a physician or other supplier may have more than one

``office of the billing physician or other supplier,'' and the ``office of the billing physician or other supplier'' is defined as space in which the ordering physician or other ordering supplier regularly furnishes care (and with respect to physician organizations, is the space in which the ordering physician performs substantially the full range of patient care services that the ordering physician provides generally). We are adding to Alternative 2 the requirement, with respect to the TC, that the physician supervising the TC be an owner, employee, or independent contractor of the billing physician or other supplier, and, with respect to the PC, that the physician performing the PC be an employee or independent contractor of the billing physician or other supplier. We are doing this in order to simplify our rules and to avoid having a separate basis for imposing an anti-markup payment limitation for TCs supervised and PCs performed by outside suppliers. We explain our rationale for this change in the next paragraph.

We are not finalizing a definition of outside supplier, and instead we are deleting references to a ``purchased'' test or interpretation in

Sec. 414.50 because they are unnecessary, as explained below. We note that section 1842(n)(1) of the Act requires us to impose an anti-markup payment limitation on diagnostic tests that are performed or supervised by a physician who does not share a practice with the billing physician or other supplier. Traditionally, we have interpreted section 1842(n)(1) of the Act as applying to purchased TCs from an outside supplier. Our longstanding policy of having an anti-markup payment limitation on purchased TCs was codified in Sec. 414.50, and retained in the CY 2008 PFS final rule with comment period. (Similarly, we imposed an anti-markup payment limitation on purchased PCs in the CY 2008 PFS final rule with comment period and we proposed in the CY 2009

PFS proposed rule to retain status as a purchased PC as a separate basis imposing an anti-markup payment limitation.) Based on our decision to adopt Alternative 1 and to allow arrangements that do not meet the requirements of Alternative 1 to nevertheless avoid the anti- markup payment limitation if diagnostic testing services meet the requirements of Alternative 2, we believe that it is not necessary, and unduly complex, to use purchased tests and purchased interpretations as separate bases for imposing an anti-markup payment limitation. We provide a fuller explanation below, at section N.2.h., for deleting from Sec. 414.50 references to TCs and PCs purchased from an ``outside supplier.''

We are not creating an exception for tests ordered by a physician in a physician organization with no physician owners who have the right to receive profit distributions. By finalizing both proposed alternatives, we believe that our concern that the Alternative 2 approach could disadvantage nonproblematic arrangements involving nonprofit multi-specialty groups that have campus-based treatment facilities (and thus do not perform diagnostic testing in the same building as where patients are seen) largely becomes moot, as most such arrangements should be able to be structured to fit into Alternative 1, or failing that, Alternative 2.

With respect to our specific solicitations of comments, we are not revising the meaning of ``net charge'' at this time. Moreover, we are not requiring at this time direct billing instead of permitting reassignment under certain circumstances; however, we may propose to do so in a future notice of proposed rulemaking. We considered the various recommendations commenters offered for the effective date for our revisions. We have decided to not deviate from the effective date that is generally applicable to this final rule with comment period and, thus, the revisions to Sec. 414.50 will become effective on January 1, 2009.

Finally, we did not propose to make changes to the in-office ancillary services exception and are not making any changes to that exception in this final rule; however, we are aware of the commenters' concerns and may propose rulemaking on this issue in the future. a. General comments

Comment: Some commenters were concerned with their perceived complexity of the anti-markup provisions and requested that we delay making any revisions to the rule. A commenter argued that extending the application of the anti-markup payment limitation only adds another layer of unnecessary complexity and confusion to an area where physicians want to provide high quality services in a cost efficient manner. Some commenters, including a large medical association, requested that we withdraw the proposals of this rule, as well as the proposals contained in the CY 2008 PFS final rule with comment period.

In contrast, one commenter stated that the anti-markup provisions are consistent with the aforementioned medical association's code of ethics, which states that a physician should not charge a markup, commission, or profit on services rendered by others. A second commenter noted that the same medical association and many hospital bylaws strongly discourage fee-splitting. Other commenters urged us to not weaken or dilute last year's important anti-markup provision.

Response: We believe that the anti-markup provisions in Sec. 414.50, as revised by this final rule with comment period, are not inordinately complex. We agree that it would be simpler to not have any anti-markup provisions beyond what existed prior to the CY 2008 PFS final rule with comment period, but we remain convinced that additional rulemaking is necessary to address the potential for overutilization through unnecessary testing. Likewise, we agree that it would be simpler to adopt the approach, as suggested by one commenter, that we not allow any reassignment of diagnostic testing services and, instead, require direct billing, but, without studying that approach further, we have concerns that doing so may unnecessarily prevent nonabusive arrangements. Thus, the resulting rule presents some complexity in order to both allow flexibility for the industry while implementing statutory intent and addressing our concerns of

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the potential for overutilization and patient abuse. To some extent, we have simplified the anti-markup provisions in Sec. 414.50 by deleting superfluous references to purchased TCs and PCs as bases for imposing an anti-markup payment limitation, for the reasons discussed above and more fully below at II.N.2.h.

Comment: A commenter recommended that we finalize a combination of both Alternative 1 and Alternative 2, so that in order for the anti- markup provision to not apply, an employee or contractor physician should work solely for the billing group and meet the ``site-of- service'' requirements. Two other commenters recommended that we finalize both approaches and allow arrangements to avoid application of the anti-markup provisions if they comply with either approach.

Response: We have adopted an ``either or'' approach to the two proposed alternative approaches. Diagnostic testing services furnished by physicians who meet the requirements of Alternative 1 (the

``substantially all'' services approach) will not be subject to an anti-markup payment limitation. However, arrangements that do not meet the requirements of the Alternative 1 approach nevertheless will avoid application of the anti-markup provisions if they comply with

Alternative 2 (the ``site-of-service'' approach), as clarified in this final rule. We believe that compliance with either one of the two approaches finalized in this rule will implement statutory intent and address our concerns regarding overutilization and abusive billing by establishing a sufficient nexus with the billing entity to justify not applying an anti-markup payment limitation.

Comment: One commenter noted that the application of some of the proposed changes, both with respect to the anti-markup provisions in

Sec. 414.50 and with respect to the IDTF standards in Sec. 410.33, may restrict the diagnostic testing services that physicians perform for Medicare beneficiaries and may result in more physicians electing to not accept new Medicare patients. A commenter stated that the proposed revisions to the anti-markup provisions threaten cooperative ventures and arrangements and, consequently, beneficiary access to quality Medicare services, including ultrasound and other diagnostic testing services. Other commenters asserted that both proposed approaches are misguided and do not acknowledge the way that physicians provide care under practical circumstances. A commenter contended that both proposals would hamper the ability of large groups to provide diagnostic services. Essentially, physician groups may have to bill differently for some physicians, resulting in an administrative burden for physician groups, and possibly curtailing the locations that a

Medicare beneficiary can receive diagnostic tests and thus affecting patient care. Several commenters argued that the adoption of this rule will have the effect of eliminating many legitimate, nonabusive arrangements that serve to expand access to care to Medicare beneficiaries, while resulting in little or no countervailing benefit to the Medicare program

Response: We do not believe that the revisions included in this final rule with comment period will discourage significantly or negatively impact significantly legitimate, nonabusive arrangements. We believe that the revisions strike an appropriate balance between allowing billing physicians and other suppliers flexibility in structuring their arrangements while protecting against program abuse caused by unnecessary diagnostic testing. As explained in section II.I. of this final rule, we are not finalizing our proposals at this time to require physician offices to comply with the IDTF standards in Sec. 410.33.

Comment: Some commenters stated that there is no evidence that bringing diagnostic services into a physician practice automatically leads to overutilization; rather, many practices do so in order to improve quality of patient care and efficiency and not for financial gain.

Response: We disagree with the commenters' statement that there is no evidence that self-referral of diagnostic services leads to overutilization. We cited several studies in the CY 2008 PFS final rule with comment period that supported the proposition that physician self- referral (that is, the referral of diagnostic tests provided within the physician practice) leads to overutilization (72 FR 66311 through 66312). Additionally, since publication of that rule, the Government

Accountability Office (GAO) has published a study indicating the overuse of some diagnostic testing when performed in a physician's office. The GAO report, Rapid Spending Growth and Shift to Physician

Offices Indicate Need for CMS to Consider Additional Management

Practices, (GAO-08-452), showed that spending for imaging services paid under the PFS more than doubled over a 6-year period from 2000 through 2006. The report's findings reflect a link between spending growth and the provision of imaging services in physician offices. The proportion of Medicare spending on imaging services performed in-office rose from 58 percent to 64 percent and physicians received an increased share of their total Medicare revenue from imaging services. We recognize that not all arrangements necessarily lead to overutilization. However, we are not able to regulate per individual practice and instead must issue rules of general applicability to implement statutory intent and address our concerns regarding the potential for overutilization through unnecessary diagnostic testing. b. Statutory Authority

Comment: A commenter noted that the anti-markup provisions in section 1842(n)(1) of the Act are limited to ``diagnostic tests described in section 1861(s)(3) [of the Act].'' According to the commenter, the physician interpretation of a diagnostic test is not a service described in section 1861(s)(3) of the Act, as physician services are described in section 1861(s)(1) of the Act. Other commenters stated that, in enacting section 1842(n) of the Act, the

Congress specifically limited the applicability of the anti-markup provisions to diagnostic tests. Commenters expressed concern that applying an anti-markup payment limitation to the PC of diagnostic tests is inconsistent with the plain meaning of the law and

Congressional intent.

Response: As explained in the preamble to the CY 2008 PFS final rule with comment period (72 FR 66308 through 66309), despite the fact that we implemented section 1842(n)(1) of the Act to impose an anti- markup payment limitation only on the TC of diagnostic tests, we are not prevented from applying an anti-markup payment limitation to the PC of a diagnostic test.

We believe that our general rulemaking authority under sections 1102(a) and 1871(a) of the Act provides us with authority to effectuate fully the Congress's intent in enacting section 1842(n)(1) the Act to remove the profit incentive for ordering unnecessary diagnostic tests.

As we indicated in the preamble to the CY 2008 PFS final rule with comment period, the profit incentive to order unnecessary diagnostic tests remains if the billing physician or other supplier may markup the

PC of the test (72 FR 66315). Moreover, and as also discussed in the preamble of the CY 2008 PFS final rule with comment period, section 1842(b)(6) of the Act authorizes us, but does not command us, to allow reassignment of physician services, including the PC of a diagnostic test (72

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FR 66309). At this time, we are not prohibiting reassignment of PCs and instead requiring direct billing, but we are imposing restrictions on the reassignment of PCs. That is, a PC that is reassigned by the performing physician to the billing physician or other supplier that ordered the PC may not be marked up by the billing physician or other supplier, unless the performing physician shares a practice with the billing physician or other supplier. If a physician or other supplier that orders a PC does not find that billing for the PC under an arrangement that is subject to the anti-markup provisions is profitable or financially worthwhile, that physician or other supplier is free to not accept reassignment and instead have the performing physician or other supplier bill directly for the PC.

Comment: Several commenters questioned the appropriateness or the legality of imposing an anti-markup payment limitation on the TC supervised by, or the PC personally performed by, a physician in the same group practice as the ordering physician. Some commenters asserted that, because the anti-markup provision in section 1842(n) of the Act, with its relatively general language, came first, and the much more specific requirements of the physician self-referral law in section 1877 of the Act came later, the Congress has defined specifically what it means for physicians to ``share a practice'' for Medicare purposes and we should not interpret these provisions differently, particularly without providing a clear rationale for doing so. One commenter contended that the ``share a practice'' concept in section 1842(n) of the Act simply was the Congress' short-hand version of what later became the lengthy definition of ``group practice'' in section 1877(h)(4) of the Act. Other commenters asserted that, through the anti-markup provisions, we are overlaying a new and inconsistent set of requirements for providing diagnostic testing, with respect to bona fide group practices meeting the physician self-referral law requirements. According to these commenters, we are doing so by relying on the ``anti-mark-up'' language of section 1842(n)(1) of the Act, even though that language pre-dates the physician self-referral law and explicitly exempts testing performed by physicians who ``share a practice.'' One commenter stated that our proposals, if adopted, would impose a new and untenable burden on physician practices that have already taken pains to comply with the complex and onerous strictures imposed by the physician self-referral law. Two commenters stated that developing policies under one law only to make them largely irrelevant under another law represents arbitrary government action.

Response: Section 1877(h) of the Act expressly states that the definitions it sets forth apply only for purposes of section 1877 of the Act. There is no indication in either the text or the legislative history of section 1877(h) of the Act that the Congress intended the definition of ``group practice'' to correlate with the term ``shares a practice'' in section 1842(n)(1) of the Act. Also, we note that the definition of group practice in section 1877(h) of the Act is relatively narrow. That is, the definition of ``group practice'' in section 1877(h) of the Act refers only to ``members'' of a group practice, which could be construed to mean only physicians with an ownership or investment interest in the group. (Note also that the definition of ``group practice'' in section 1877(h) of the Act allows the Secretary to impose other standards by regulation.) Likewise, the text of the in-office ancillary services exception in section 1877(b) of the Act, which allows referrals within a group practice, can be read as being restricted to services referred and performed by members of the group (and services performed by employees who are supervised by a member of the group). Therefore, even if the Congress did intend the definition of ``group practice'' in section 1877(h) of the Act for purposes of the physician self-referral law to correlate with ``shares a practice'' in section 1842(n)(1) of the Act for purposes of the statutory anti-markup provision, and also intended that individuals whose referrals are protected under the statutory in-office ancillary services exception to the physician self-referral law necessarily

``share[] a practice'' for purposes of the statutory anti-markup provision (and we agree with neither proposition), we would not be required to take an expansive view of what it means to ``share[] a practice'' for purposes of the statutory anti-markup provision. We also note that section 1842(n)(1) of the Act does not prohibit us from using other authority to impose an anti-markup payment limitation on TCs and

PCs.

As a policy matter, we do not agree with the commenters that suggested that we should except from the anti-markup provisions any arrangement that complies with the physician self-referral rules. The anti-markup provisions, when applied, limit only how much a physician or other supplier may bill Medicare, whereas the physician self- referral rules, when implicated and not satisfied, prevent a physician or other supplier (or provider) from billing Medicare (for any amount).

Accordingly, we approach physician self-referral rulemaking with added caution, lest we prohibit a broad class of arrangements that in some cases and under certain circumstances do not pose a risk of abuse.

Thus, using our general rulemaking authority and authority in section 1877(b)(2) of the Act, we have provided some flexibility, with respect to which referrals are protected under the in-office ancillary services exception and the definition of a ``centralized building,'' for purposes of our physician self-referral rules. However, the fact that the physician self-referral law, as interpreted or implemented by us, does not prohibit a certain type of arrangement does not mean that we should not take measures, through an anti-markup approach, to address the potential for overutilization or other abuse that exists with certain arrangements that seek to take advantage of our definitions of

``group practice'' and ``centralized building'' that are used for purposes of the physician self-referral exception for in-office ancillary services. c. Alternative 1 (``Substantially All'' Professional Services)

Comment: Under Alternative 1 as proposed, which we referred to in the proposed rule as the ``shares a practice'' approach (although the second alternative was also designed to ensure, through a site-of- service methodology, that performing physicians ``share a practice'' with the billing physician or other group), the anti-markup payment limitation would not apply if a service is provided or supervised by a physician who ``shares a practice'' with the billing physician or other supplier by virtue of working exclusively with that physician or other supplier. Several commenters noted that this alternative mirrors the statutory language, but contended that the definition of ``shares a practice'' suggested by the preamble of the proposed rule (that is, if a physician contracts with more than one group, he or she does not

``share a practice'' with any group) is inconsistent with a common sense interpretation of that term. A commenter stressed that even a physician who spends 1 percent of his or her time interpreting echocardiograms for an area hospital but spends the remainder of his or her time working for his or her group practice would not be considered to ``share a practice'' with the group under the

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proposed approach. Some commenters suggested that physicians should be able to have two or three relationships with physician organizations and still be deemed to share a practice with each one and not be subject to the anti-markup provisions. Some commenters requested that the anti-markup provisions not apply when a physician works for a physician group and also works for another type of health care provider or supplier, such as a hospital, independent lab, or medical school.

Another commenter proposed that a physician who spends more than 40 percent of his ``total time spent on patient care services'' (as defined at Sec. 411.352(d)) as a physician in any group practice should be considered to ``share a practice'' with that group practice for purposes of the anti-markup provisions. According to the commenter, this requirement would ensure that a physician has a meaningful level of actual economic and professional integration with a group practice for which the physician provides DHS from which the group can profit, but it would not penalize a physician for providing professional and supervisory services to others. The commenter suggested that we should permit a physician to share a practice with no more than two groups and require extensive integration with each group.

A commenter stated that, if a physician is a full-time or part-time employee of a physician group, that employment relationship in and of itself should establish a sufficient nexus with that group to justify not applying the anti-markup payment limitation to his or her professional services for the physician group. This commenter also noted that, under the proposed IDTF revisions in the CY 2009 PFS proposed rule (73 FR 38533 through 38535), a physician may serve as an

IDTF medical director for no more than three IDTFs, and suggested that a similar standard could be used for the application of the anti-markup provisions by not allowing physicians to contract to provide services for more than three physician organizations.

One commenter stated its belief that compliance with the proposed requirements of the Alternative 1 approach may be possible by some medical practices, such as those with the capital and testing volumes sufficient to warrant engaging or contracting for exclusive physician services needed to perform or supervise diagnostic testing. However, the commenter also asserted that the proposal may be burdensome to many physician offices. Another commenter asserted that some practices do not have sufficient patient volume to support a full-time pathologist or radiologist. A commenter representing an oncology practice noted that the practice currently can bill a global fee for the TC and PC, but the Alternative 1 proposal would apply the anti-markup payment limitation to the PC. The commenter stated that use of a part-time radiologist does not encourage overutilization, and, therefore, the anti-markup payment limitation should not apply.

Response: We are modifying the proposed Alternative 1 approach so that a performing physician (that is, a physician who supervises the TC or performs the PC, or both) will be considered to share a practice with a physician, physician organization, or other supplier if the physician furnishes ``substantially all'' (at least 75 percent) of his or her professional services through that physician, physician organization, or other supplier. This means that a physician may furnish up to 25 percent of his or her professional services through any number of physicians (including himself or herself), physician organizations or other suppliers, through acting as a locum tenens physician, or in other circumstances without disqualifying himself or herself from sharing a practice with the physician or physician organization for which he or she provides the bulk (that is, at least 75 percent) of his or her professional services. For example, suppose

Physician A furnishes at least 75 percent of her services through

Physician Organization B, and furnishes 25 percent of her professional services through Physician C and Laboratory Supplier D. Under this example, Physician A would be considered to be sharing a practice with

Physician Organization B.

Revised Sec. 414.50(a)(2)(ii) provides that the ``substantially all'' requirement is satisfied if the billing physician or other supplier has a reasonable belief, when submitting a claim, that: (1)

The performing physician has furnished substantially all of his or her professional services through the billing physician or other supplier for the period of 12 months prior to and including the month in which the service was performed; or (2) the performing physician will furnish substantially all of his or professional services through the billing physician or other supplier during the following 12 months (including the month the service is performed).

Comment: In response to our request for comments on how to address locum tenens relationships under Alternative 1, several commenters recommended that the locum tenens relationships should not count in calculating whether a physician shares a practice with another physician or other supplier. Another commenter suggested that abuse of locum tenens arrangements could be avoided through requirements for these arrangements in the Medicare Claims Processing Manual, 100-04,

Chapter 1, Sec. 30.2.11. One commenter stated that, provided that locum tenens physicians satisfy Medicare's requirements governing the use of and billing for such physicians, the anti-markup payment limitation should not apply to tests performed or supervised by such physicians.

One commenter enumerated additional circumstances in which group practice physicians provide services to or through entities other than their primary group affiliation. These circumstances included: (1)

Covering for another practice while it recruits to replace a retired or deceased physician; (2) providing specialty services at hospitals or primary care clinics in areas (often rural, but not always) that would otherwise not have those specialties available and convenient to patients; and (3) providing specialty services to a different practice that has only a part-time need for the service.

Another commenter noted the potential for situations where a non- radiology practice contracts with a radiologist as a locum tenens physician to circumvent the anti-markup provision. The commenter recommended that we exclude only same-specialty locum tenens arrangements from the anti-markup provision.

Response: In the CY 2009 PFS proposed rule, we requested comments on how, under Alternative 1, we could permit a physician to provide occasional services outside of his or her physician organization without the secondary arrangement precluding the physician from sharing a practice with the physician organization for purposes of applying the anti-markup provisions. To accommodate such temporary physician arrangements, we have modified Alternative 1 so that a physician will be considered to share a practice with a physician, physician organization, or other supplier if the physician furnishes at least 75 percent of his or her professional services through that physician, physician organization, or other supplier. Thus, the final rule allows a physician to furnish up to 25 percent of his or her professional services through other arrangements (including for the purpose of acting as a locum tenens physician)

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without disqualifying himself or herself from sharing a practice with his or her primary physician practice. We believe that our modification provides assurance that the performing physician has a sufficient nexus with the billing physician or other supplier so as to share a practice with such physician or other supplier. We are not persuaded that we should disqualify the performing physician from sharing a practice with the billing physician or other supplier if his or her locum tenens or part-time arrangements do not involve performing work for a billing physician or other supplier engaged in the same specialty as the performing physician.

Immediately above, we address the issue of whether a physician may share a practice with a billing physician or other supplier despite furnishing some services through other arrangements, including acting as a locum tenens physician. In this paragraph, we address the ``flip side'' of this issue, that is, whether a billing physician or other supplier can avoid application of the anti-markup payment limitation where a locum tenens physician is substituting for a physician who does in fact perform ``substantially all'' of his or her professional services through the billing physician or other supplier. We wish to clarify that, with respect to locum tenens situations only, whether an arrangement satisfies Alternative 1 depends on whether the permanent physician (that is, the physician for whom the locum tenens physician is substituting) performs ``substantially all'' of his or her professional services through the billing physician or other supplier.

For example, assume Physician A contracts with Group Practice C to render services in place of Physician B, who is on vacation. Physician

B performs 100 percent of her professional services through Group

Practice C. This arrangement meets the requirements of Alternative 1, because Physician B performs at least 75 percent of her professional services through Group Practice C. It is irrelevant whether, or the extent to which, Physician A furnishes professional services for Group

Practice C outside the locum tenens arrangements, for purposes of determining whether the anti-markup payment limitation applies to the services provided by Physician A under the locum tenens arrangement.

Comment: Many commenters were opposed to the proposed Alternative 1 approach to determining whether a physician shares a practice with the billing physician or other supplier. Some commenters stated that they employ a pathologist in-house in order to improve quality of care by:

(1) Using specialized pathologists for digestive diseases; (2) forming normative standards based on the practices of the physicians in the practice; and (3) decreasing the turnaround time for diagnostic tests.

Other commenters, who are physicians, stated that they were unhappy with the professional services provided by commercial laboratory companies due to slow turnaround time on pathology reports or difficulty in asking follow-up questions of pathologists at remote laboratories. According to these commenters, by employing a pathologist, a group practice is able to ensure that the pathologist is a specialist in a particular practice area (for example, gastroenterology), something the commenters asserted they were unable to do with commercial laboratories.

A commenter expressed concern regarding Alternative 1 because, in the commenter's view, it would unfairly limit a specialty practice

(such as gastroenterology or urology) from billing and collecting the full global reimbursement from the Medicare program for services rendered by an in-office pathologist unless that pathologist works only for that physician group. The commenter stated that it should not matter if the pathologist works for more than one group practice. This commenter expressed concern that eliminating the in-office laboratory model would be a detriment to Medicare beneficiaries. Another commenter objected to our assertion that anatomic pathology services provided in a physician's office can result in overutilization. The commenter expressed its view that gastroenterologists do not overutilize anatomic pathology, even when profiting from it, because a colon biopsy is much more invasive than clinical laboratory tests such as fingerstick for hematocrit or a dipstick urine.

Response: Billing physicians and other suppliers will continue to be able to employ a physician specialist on a part-time basis. Under

Alternative 1, if the specialist furnishes ``substantially all'' (at least 75 percent) of his or her professional services through the billing physician or other supplier, the specialist ``shares a practice'' with the billing physician or other supplier. Because this rule finalizes both proposed approaches, if an arrangement does not satisfy the ``substantially all'' test of Alternative 1, the billing of a TC or PC may still avoid application of the anti-markup payment limitation if it meets, as determined on a case-by-case basis, the

``site-of-service'' requirements of Alternative 2. Alternatively, part- time physicians can bill Medicare directly.

Comment: Some commenters contended that adoption of Alternative 1 would interfere unfairly with the practice of medicine by severely limiting physician practices' right to organize themselves as they see fit to deliver quality care to their patients. These commenters stated that adoption of Alternative 1 would prevent a group from hiring a part-time pathologist, as is common for gastroenterology practices that provide pathology services to their patients. According to the commenters, the elimination of full reimbursement (that is, the PFS amount) for pathology services provided by part-time pathologists would interfere with the multidisciplinary approach that the commenters have chosen to best serve patients. One commenter asserted that, despite the fact that the pathologist simply may bill the Medicare program directly, Alternative 1 interferes with the practice of medicine. The commenter asserted that our proposal is equivalent to saying that a physician group cannot hire a part-time pathologist as part of its practice. The commenter contended that finding a pathologist who would travel to its offices was not easy, and that informing a pathologist that he or she can bill Medicare directly from the group's office provides no incentive to the pathologist. This commenter predicted that the approach outlined in Alternative 1 would force pathology to revert to the traditional model of referring physicians sending specimens to a laboratory and receiving pathology reports, rather than communicating with the pathologist directly. One commenter stated its belief that, if we permit a pathologist to bill for professional services directly, there is no reason for the pathologist to travel to different physician's offices if he or she can collect the same amount for professional fees while working in his or her own office. This commenter also suggested that our proposal would discriminate against small groups that cannot afford to employ a full-time pathologist. The commenter asserted that full-time pathologists based in small communities do not have the resources to bill and collect on their own and working for one group on a part-time basis is not sufficient.

One commenter stated that it would support Alternative 1 if it was extended to allow a physician to be employed by or under contract with up to three physicians or physician organizations. Commenters recommended that the ``one practice'' requirement be eliminated so as not to harm small and

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mid-sized practices that cannot afford to employ a full-time pathologist. Two commenters stated that a physician should be allowed to maintain ``two or three'' independent contractor or employee relationships with physician organizations and be viewed as sharing a practice with each. In the commenters' view, this less restrictive approach would account for different practice situations while still providing considerable protection against Medicare program abuse.

Another commenter requested that, in drafting any final rule, we permit physicians to provide services in rural health or medically underserved areas without the secondary arrangement precluding the physician from sharing a practice with his or her physician organization.

Response: We have modified Alternative 1 so that a physician group will be allowed to hire a part-time physician who will ``share a practice'' with that group, provided that the part-time physician furnishes ``substantially all'' (at least 75 percent) of his or her professional services through the group. Again, in order to avoid application of the anti-markup payment limitation under this final rule, billing physicians and other suppliers have the option of satisfying either the requirements of Alternative 1 (the

``substantially all'' professional services approach), or the requirements of Alternative 2 (the ``site-of-service'' approach).

Comment: One commenter suggested that Alternative 1 may be simpler and more effective if we clarify that the anti-markup provisions apply only when the billing physician or physician organization generated the referral for the pathology services. The commenter noted that, in

States that prohibit the corporate practice of medicine, independent clinical laboratories contract with pathology groups to perform pathology services. Because such pathologists have employment or contractual relationships with both a pathology group and an independent lab, the anti-markup provisions could be triggered under

Alternative 1 as proposed. The commenter cited the CY 2008 PFS final rule with comment period, where we stated that independent laboratories and pathologists do not trigger the initial order for pathology services. Thus, the commenter suggested that we clarify that, under the

CY 2009 PFS proposals, anti-markup provisions still would only apply if the physician billing for the services was also the physician or supplier who provided the initial order for the service. Several commenters were concerned that we did not mention this in our commentary on the proposal.

Response: As finalized in the CY 2008 PFS final rule, and as retained in this final rule with comment period, the anti-markup provisions for the TC or PC of a diagnostic test apply only when the billing physician or other supplier has ordered the TC. For example, if a laboratory contracts with a pathologist instead of employing the pathologist to perform the PC of a diagnostic test (because the laboratory is located in a State that has a prohibition on the corporate practice of medicine), the anti-markup payment limitation would not apply to the lab if the lab chooses to bill for the pathologist's interpretation, if the lab (or a party related to the lab by common ownership or control) did not order the test. For example,

Physician Group A orders the TC and PC of a diagnostic test. Laboratory

B performs TC and contracts with Physician C to perform the PC, and

Laboratory B bills for the TC and the PC. In this example, the anti- markup provisions would not apply to the TC or the PC billed by

Laboratory B. However, if the interpreting pathologist decides to order additional tests that are then performed and/or interpreted by another pathologist, the anti-markup payment limitation potentially would apply if the ordering pathologist wishes to bill for the additional interpretations performed by the different pathologist. Whether the anti-markup payment limitation in fact would apply would depend on whether the arrangement between the ordering/billing pathologist and the pathologist performing or supervising the TC/performing the PC satisfies the requirements of Alternative 1 (and, if not, whether it satisfies, on a case-by-case basis, the requirements of Alternative 2).

Comment: Some commenters offered support for Alternative 1. The commenters believed that this alternative has greater potential to limit self-referral arrangements by requiring that a physician practice should not be able to mark up anatomic pathology tests unless the physician who performs and supervises the pathology services is dedicated solely to that physician practice. Another commenter strongly urged us to focus on this alternative to apply the anti-markup provision to all TCs and PCs of diagnostic tests that are ordered by the billing physician or other supplier unless the physician who performs and supervises the pathology services is dedicated solely to that physician practice or physician organization. According to the commenter, this would protect legitimate multi-specialty group practices that employ their pathologists on a full-time basis.

One commenter expressed support for not allowing a pathologist to work for more than one group (pathology or subspecialty) in order to maintain the quality and integrity of anatomic pathology. Other remedies proposed by this commenter included disallowing any profit made from anatomic pathology by the physician taking the biopsy, or allowing ``upcharging'' only on tests that can be reported that same day.

Response: We believe that it is not necessary to go so far as requiring a physician not to work for more than one physician organization, because requiring a physician to furnish ``substantially all'' (at least 75 percent) of his or her professional services through a billing physician or other supplier addresses our concerns regarding overutilization and abusive billing and also allows physicians the flexibility to work for other physician groups or health care entities or to work as a locum tenens physician.

Comment: A commenter requested that, if Alternative 1 is finalized, we clarify that a physician employee would be considered to be sharing a practice with a physician or a physician group whether the physician is hired directly or is a leased employee, whereas other commenters stated that employment and contractual arrangements might not be enough for determining whether a physician ``shares a practice'' as this could be circumvented via shareholder, ownership, or joint partnership arrangements.

A commenter asked that we consider including physicians who are employed by affiliated (common ownership) organizations. This would allow affiliated organizations to share physician resources and expertise when interpreting tests via teleradiology. The commenter also noted a concern that employers may not have knowledge of all independent physician and supplier contracts and may not have sufficient mechanisms to ensure sole employment. This commenter requested clarification on how to manage independent physician and supplier contracts to ensure that physicians are employed by only one organization.

Response: As finalized, any physician (that is, regardless of employment status or whether he or she is an owner of the billing entity) who performs ``substantially all'' (at least 75 percent) of his or her professional services for a billing physician or other supplier will be deemed to share a practice with that billing physician or other supplier.

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d. Alternative 2 (``Site-of-Service'')

Comment: One commenter opposed our reproposal of the existing

``site-of-service'' approach for determining whether the physician performing or supervising the TC or PC of a diagnostic test shares a practice with the billing physician or other supplier, asserting that it will do little to stifle the growth of self-referral in lab arrangements. According to the commenter, this alternative focuses only on where the test is performed and not by whom, and, thus, specialty practices could profit from their referrals simply by bringing ``pod labs'' in-house to the location where the group provides physician services. The commenter advocated for the rule to require clearly a greater connection and integration between the performing physician and the practice before the practice can profit from lab tests ordered by physicians in the group.

Response: We recognize the potential for arrangements that may be troublesome to be restructured so that the diagnostic testing is performed in the same building as where the testing is ordered; however, we are also concerned that adopting Alternative 1 without leaving in place the site-of-service approach of Sec. 414.50 (which we reproposed as Alternative 2) may unnecessarily disrupt some arrangements that do not appear problematic to us. We will continue to monitor arrangements and may propose further changes if necessary.

Also, we continue to examine industry use of the in-office ancillary services exception of the physician self-referral rules, and may propose changes to that exception in a future rulemaking.

Comment: Some commenters did not believe that site-of-service distinctions are relevant to determining the appropriate scope of section 1842(n) of the Act. According to the commenters, it should not matter if physicians are in a bona fide group practice that has one building or ten, and, if ten, the particular geographic configuration of the ten buildings should not matter. The commenters questioned the legal or policy justification for applying different site-of-service rules for purposes of the anti-markup provision than those that are employed in the physician self-referral regulations. Of particular concern for these commenters are distinctions that treat groups differently from solo practitioners and that discriminate between different types of groups. The commenter gave the example of a solo practitioner with five offices with an x-ray machine in each: provided that he or she regularly practiced in each office, he could order diagnostic tests at all five locations, or from any one of them, and the tests would be treated as ``furnished'' inside the practice rather than ``purchased.'' According to the commenter, a group practice, on the other hand, that has primary care physicians in one building and specialists in another either has to have x-ray machines in both buildings, to be used only by the physicians in each building, or do diagnostic testing in only one building and treat the group practice members in the other building as ``purchasing'' the tests. The commenter also described its understanding of the proposed rule, stating that, when diagnostic tests are provided in a centralized building by a non-profit multi-specialty group, they would be considered ``furnished,'' but the same tests provided by a physician- owned group that is otherwise comparable in size and scope would be considered ``purchased.'' The commenter questioned the relevance of these distinctions related to quality, convenience, efficiency, utilization, or potential abuse.

Response: Because the definition of ``centralized building'' at

Sec. 411.351 contains no requirements for minimum size, proximity to the billing group's office, or staffing, and because our current policy under the physician self-referral rules is to allow billing groups to have more than one centralized building, we are concerned that the potential exists for overutilization of diagnostic testing through arrangements involving a billing group and physicians who have little or no real connection to the billing group other than to serve as a point of referral to generate profits for the billing group. We believe that a site-of-service approach, employing the ``same building'' test, is a reasonable means of determining whether a physician shares a practice and has a sufficient nexus with the billing physician or other supplier.

We reiterate that, in addition to section 1842(n) of the Act (and our general rulemaking authority in sections 1102(a) and section 1871(a) of the Act to ``gapfill'' in order to effectuate fully the

Congress's intent in section 1842(n) of the Act to impose an anti- markup provision on certain diagnostic tests), we have authority under section 1842(b)(6) of the Act to prescribe limitations on the reassignment of tests and test interpretations. However, in this final rule with comment period, we have adopted an ``either/or'' approach to the two proposed alternatives. That is, a billing physician or other supplier can avoid application of the anti-markup provisions by meeting either the ``substantially all'' professional services approach of

Alternative 1 or, on a case-by-case basis, the ``site-of-service'' approach of Alternative 2, which are set forth in revised Sec. 414.50(a)(2)(ii) and (iii). We believe that compliance with either one of the two approaches finalized in this rule will further our goal of reducing the potential for overutilization and other program or patient abuse while providing sufficient flexibility for the industry.

Comment: One commenter contended that a ``one building'' ``site-of- service'' standard is not a realistic means of ensuring proper billing arrangements, as large single specialty practices often span beyond one building. Another commenter remarked that the site-of-service alternative should not be finalized because it would be problematic for groups where specimens are collected at multiple sites but pathology diagnostic testing services are done at a separate location owned or leased by the group (the ``hub-and-spoke'' arrangement). Some cardiologists also expressed concern that interpretations of EKGs and other diagnostic testing services may be limited by the proposed site- of-service approach. One commenter provided the example of a group that has three offices but only one with a CT scanner. The commenter noted that under the site-of-service approach, the anti-markup provision would apply to tests ordered and supervised by physicians employed by the group unless the physicians worked in the same office where the CT scanner was located.

Response: We believe that allowing billing physicians and other suppliers to comply with either the ``substantially all'' professional services approach of Alternative 1 or the ``site-of-service'' approach of Alternative 2 will address our concerns while providing sufficient flexibility for the industry. In the situations described by the commenters, if the performing physician furnished substantially all of his or her professional services through the billing group, the anti- markup payment limitation would not apply.

Comment: A commenter stated that the Alternative 2 site-of-service approach is useful in deterring program abuse at locations other than the office of the billing physician, and may benefit from being merged with Alternative 1. However, the commenter asserted that we must address the issue of the level of supervision that is required for the

TC of a pathology service. According to the commenter, it is unclear what level of supervision of the TC must be furnished and where it must be furnished, as CLIA does not govern the TC of a pathology service.

The

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commenter suggested that we require that the TC be supervised by a physician who meets, at a minimum, the general supervisor requirements under CLIA, including the requirements for the subspecialties of histopathology or dermatopathology, as necessary.

Another commenter expressed concerns about supervision requirements, noting that ``the physician who supervised the TC'' is not defined in the proposed rule or CLIA. The commenter suggested that the supervising physician should meet the requirements for a laboratory director under CLIA or use IDTF requirements. The commenter noted that, in a separate proposal in the CY 2009 PFS proposed rule (73 FR 38533 through 38535), we proposed to require physicians performing testing in their offices to enroll as IDTFs and meet the IDTF requirements. Among the applicable requirements of that proposal are that the supervising physicians have proficiency in the testing service being supervised and meet the specific requirements established by medical specialty groups or carriers.

Response: With respect to our proposal to revise the anti-markup provisions in Sec. 414.50, we did not propose to impose special standards or qualifications on the physician supervising the TC, and decline to do so here. Section 410.32 establishes the level of supervision (general, direct, or personal) for diagnostic tests potentially subject to the anti-markup provisions (that is, services covered under section 1861(s)(3) of the Act and paid under part 414 of this chapter (other than clinical diagnostic laboratory tests paid under section 1833(a)(2)(D) of the Act, which are subject to the special billing rules set forth in section 1833(h)(5)(A) of the Act)).

Comment: A commenter requested that if we adopt the Alternative 2 approach, we clarify that block leases meeting the in-office ancillary services exception ``same building'' test would not trigger the anti- markup provision. Another commenter stated that it favored the

Alternative 2 ``site-of-service'' approach and that the anti-markup provisions should apply to any shared facility in the ``same building.''

Response: We are adopting, in part, the position favored by the first commenter. Specifically, we are finalizing the Alternative 2 approach, which employs the definition of ``same building'' as defined at Sec. 411.351 (as we proposed). However, we are not incorporating each element of the same building ``location'' test from the in-office ancillary services exception as set forth in Sec. 411.355(b)(2). A TC that is performed (that is, both conducted by the technician and supervised by the physician) in the ``office of the billing physician or other supplier'' will not be subject to the anti-markup payment limitation. Likewise, a PC that is performed in the ``office of the billing physician or other supplier'' will not be subject to the anti- markup payment limitation. Diagnostic testing services are performed or interpreted in the ``office of the billing physician or other supplier'' if they are performed or interpreted in the ``same building'' (as defined in Sec. 411.351) as the space in which the ordering physician or other ordering supplier regularly furnishes patient care. In the CY 2008 PFS, we stated that various stakeholders informed us that a physician organization, such as a multi-specialty group, may not provide substantially its full range of services for a certain specialty at any one location, but rather may provide substantially the full range of services for a certain specialty in one location, substantially the full range of services for a second specialty in a second location, and so forth. In order to address this situation, we proposed to focus on the medical office space where the ordering physician provides substantially the full range of patient care services that the ordering physician provides generally.

We are not adopting the approach suggested by the second commenter.

The fact that diagnostic testing services are performed or interpreted in a space that is leased by two or more groups (but which is located in the same building as the space in which the billing physician or other supplier regularly furnishes patient care) does not cause the testing to be subject to the anti-markup provisions. Example: Physician

A has an office located on the first floor of Medical Office Building.

In his office, Physician A performs the full range of services that he provides generally (and thus the space meets the criteria for the

``office of the billing physician or other supplier'' under Sec. 414.50(a)(2)(iii). Physician A orders a diagnostic test, which is conducted by a technician and supervised by Physician B in a diagnostic testing facility located in the basement of Medical Office Building.

Physician B also performs the PC of the test in the diagnostic testing facility. Physician B reassigns her right to bill for the TC and the PC of the test to Physician A. The diagnostic testing facility is shared, under block-time exclusive use leases, by Physicians A, C and D.

Neither the TC, nor the PC, is subject to the anti-markup payment limitation, because the TC and the PC were performed in the ``office of the billing physician or other supplier.'' We are permitting shared space arrangements for diagnostic testing services that occur in the

``same building'' because we believe that such arrangements can promote efficiency without raising the same concerns for overutilization or other abuse as arrangements that involve centralized buildings for diagnostic testing. We reiterate however, that we continue to have concerns with the present use of the in-office ancillary services exception and that we may issue a proposed rulemaking at a future date to address those concerns.

Comment: One commenter supported the Alternative 2 ``site-of- service'' approach as a reasonable approach to curbing potential overutilization. One commenter characterized the ``site-of-service'' approach as more fair than the Alternative 1 approach, even though, according to the commenter, Alternative 1 may control perceived overutilization while respecting the rights of pathologists and clinicians to practice medicine in the best manner possible. Another commenter generally was supportive of both alternatives but favored the

Alternative 2 ``site-of-service'' approach because, in the commenter's view, it would better protect against physicians who wish to profit from their own referrals by preventing a multi-specialty physician organization with several practice locations from benefiting from its referrals to one central anatomic pathology laboratory. The commenter acknowledged that these ``hub-and-spoke'' arrangements may offer the advantage of patient convenience where diagnostic testing occurs following an office visit with the patient present (for example, an x- ray), but, in the context of anatomic pathology services, these arrangements do not benefit the patient and may result in overutilization and the provision of lower quality, less specialized services.

Response: We received support for both alternatives regarding when to apply the anti-markup provision to the TC and PC of diagnostic tests. After reviewing all the comments, we have decided to finalize, with some modification, both approaches. (As explained elsewhere in this preamble, we have modified the Alternative 1 approach so that the performing physician shares a practice with the billing physician or other supplier if the performing physician furnished ``substantially all'' (that is, at least 75 percent) of his or her professional services through the billing physician or other supplier, and we have modified

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the Alternative 2 approach by clarifying that the performing physician must be an employee or independent contractor of the billing physician or other supplier (which has enabled us to delete the references to purchased tests from an outside supplier.) Thus, billing physicians and other suppliers may satisfy the Alternative 1 ``substantially all'' professional services approach or, on a case-by-case basis, the

Alternative 2 ``site-of-service'' approach in order to avoid application of the anti-markup payment limitation. We believe that complying with either approach will address our concerns regarding potential overutilization and other abuse by establishing a sufficient nexus with the billing entity. e. Exception for Physician Organizations That Do Not Have Any Owners

Who Have the Right To Receive Profit Distributions

Comment: We proposed an exception to the requirement that diagnostic testing be performed in the ``office of the billing physician or other supplier'' in order to avoid application of the anti-markup payment limitation. We proposed that (except for the purchase of a TC from an outside supplier) the anti-markup provisions would not apply to diagnostic tests ordered by a physician in a physician organization that does not have any owners who have the right to receive profit distributions. Some commenters supported adopting the proposed exception. One commenter requested clarification regarding whether the exception would apply only where the physician organization does not have any owners who have the right to receive profit distributions, or whether it would apply provided that the physician organization does not have any physician owners who have the right to receive profit distributions. In the commenter's view, if a physician organization without physician owners is a non-profit entity with a member that is another non-physician non-profit entity with typical membership rights, the proposed exception still would apply to avoid application of the anti-markup provisions. Another commenter stated that an exception for diagnostic tests ordered by a physician in a physician organization that does not have any physician owners with a right to receive profit distributions is a bright-line approach and consistent with program safeguards. Another commenter also asked that physician practices with ``titular'' owners not be subject to the final rule and that the definition be consistent with the definition of

``titular'' ownership in the FY 2009 IPPS Final Rule (73 FR 48434, 48693).

One commenter questioned whether there is evidence suggesting tax- paying medical groups behave, or are likely to behave, in a manner substantially different than tax exempt medical groups. The commenter also stated that it was unaware of any instances where the Medicare program differentiates policies based solely on institutional mode of ownership, incorporation, or tax status, and questioned if we have statutory authority to create such an exception based on type of ownership.

Response: We have determined that it is not necessary to finalize an exception for diagnostic tests ordered by a physician in a physician organization that does not have any owners who have the right to receive profit distributions. By finalizing both proposed alternative approaches to avoiding application of the anti-markup payment limitation we believe that our concern that the Alternative 2 approach could hinder arrangements involving nonprofit multi-specialty groups that have campus-based treatment facilities (and, thus, do not perform diagnostic testing in the same building where patients are seen) largely becomes moot, as most such arrangements should be able to be structured (or are already structured) to meet the requirements of either the Alternative 1 or Alternative 2 approach finalized here.

Similarly, there is no need to create an exception for titular owners. f. Definition of the ``Office of the Billing Physician or Other

Supplier''

Comment: One commenter, generally supportive of our proposed clarification of the definition of ``office of the billing physician or other supplier'', questioned its application in Example 2 from the proposed rule (73 FR 38547) which would allow two separate physician organizations to share space used for diagnostic testing that is located in the same building in which the physician organizations have their respective offices. The commenter asserted that allowing two or more providers to share a laboratory undermines the anti-markup payment limitation, essentially enabling ``pod labs'' to regain their ability to facilitate markups by the referring physician or physician organization. The same commenter also requested clarification regarding

Example 3 in the proposed rule (73 FR 38547), in which a ``group practice treats patients in Buildings A, B, and C. In each of its offices in Buildings A and B, the group practice provides substantially the full range of patient care services that it provides generally, but that is not true for space located in Building C. The group practice provides diagnostic testing services in Buildings B and C.'' We noted in this example that, under the proposed definition of the ``office of the billing physician or other supplier,'' the anti-markup payment limitation would not apply to diagnostic testing services provided in

Building B, but would apply to those services provided in Building C.

The commenter stated that it agreed with our conclusion, if the ordering physician or supplier's services were provided in Building B.

According to the commenter, if the ordering physician provided his or her services in Building A, the anti-markup provisions should apply.

Response: We do not agree with the commenter's assertion that our revisions to Sec. 414.50(a)(2)(iv) undermine the anti-markup provisions and enable ``pod labs'' to regain their ability to facilitate markups. In particular, we refer the reader to the definition of the ``office of the building physician or supplier'' at

Sec. 414.50(a)(2)(iv), which includes space in which diagnostic testing services are performed, that is in the ``same building,'' (as defined at Sec. 411.351), in which the ordering physician or ordering supplier regularly furnishes patient care (and more specifically, for physician organizations, in the same building in which the ordering physician provides substantially the full range of patient care services that the ordering physician provides generally). Many of the potentially abusive pod lab arrangements that led to our extension of the anti-markup provisions to the PC of diagnostic testing services involved independent contractor pathologists who performed services in off-site pathology labs. Those arrangements did not have the type of nexus with the group practice required under Sec. 414.50(a)(2) (that is, the pod labs were not within the same building in which the ordering physician provided substantially the full range of patient care services).

We do agree with the commenter's analysis of Example 3 given in the proposed rule.

Comment: One commenter requested that, if adopted, the proposal for

Alternative 2 should include detailed examples that provide clear definitions for several key terms, including ``office of the billing physician or other supplier,'' ``conducting and supervising the TC,'' and ``full range of services.'' The commenter believes that, without these definitions, our intent will be misconstrued and subject to potential abuse.

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Response: We do not provide a definition for ``conducting and supervising the TC'' in the regulation text, as we believe that the meaning of ``conducting'' is clear on its face; that is, the term

``conducting the TC'' refers to the technician's (or physician's) performance of the test. Nor do we believe that it is necessary to define the term ``supervising.'' For a service to be covered by

Medicare, the regulations at Sec. 410.32 define and specify various levels of supervision (that is general, direct, or personal supervision). The anti-markup provisions, when applied, limit the amount a physician or other supplier may bill Medicare. In the context of the applicability of the anti-markup provisions, we are requiring that the physician supervising the TC be present in the same building

(as defined at Sec. 411.351); however, this has no impact on other

Medicare billing requirements, which may require a specific level of supervision as described above. We decline to define the term ``full range of services,'' because this would vary greatly based on factors such as the specialty of the ordering physician, the types of services within the physician's specialty, and the focus of services at the specified practice.

Comment: According to one commenter, the ``office of the billing physician or other supplier'' for multi-specialty groups should include medical office space in which the physician group provides substantially the full range of services of one or more of the specialties of the group. The commenter contended that this requirement would ensure an adequate nexus between the physician practice and the testing being conducted in the building. The commenter asserted that limiting the location to a building in which the ordering physician provides substantially the full range of services that the ordering physician typically provides imposes unnecessary restrictions that are overly burdensome when compared to the purpose of the proposed rule.

Another commenter, in similar comments, urged us to consider replacing

``ordering physician'' with the words ``ordering physician or a member of the ordering physician's group practice.'' According to the commenter, this revision would permit any physician member of a group practice to utilize the group's centralized designated health service

(``DHS'') facility (and bill under the normal physician fee schedule), provided that the facility is located in the same building where the group practice provides patient care services on a full-time basis. To avoid the potential problem presented by a group practice with multiple offices, none of which provide the full range of patient care services provided by the group as a whole, the group proposed that we eliminate the requirement that the group practice provide in the same building

``substantially the full range of patient care services that [it] provides generally.'' The commenter suggested replacing this requirement with a requirement that the group practice provide in the same building ``physician services unrelated to the provision of DHS on a full time basis.'' According to the commenter, this revision would be consistent with the physician self-referral law and regulations, would permit all physician members of a group practice to utilize the group's centralized DHS facility (provided that the facility is located in the same building where the group provides other physician services), and would permit the group to bill for all DHS provided in such a facility under the Medicare physician fee schedule.

Response: We believe that the changes recommended by the commenters would not guard adequately against potential overutilization. In addition, we believe that sufficient flexibility is afforded multi- specialty groups and others by allowing arrangements to satisfy the requirements of either the Alternative 1 or the Alternative 2 approach, as revised.

Comment: One commenter expressed concern that the provision is more complicated than necessary and, rather than a definition of ``office of the billing physician or other supplier,'' a definition of an ``outside entity'' is needed to determine which services would be affected by the anti-markup provisions. The commenter suggested ``outside entity'' should be defined as an entity with a different identification number

(for example, tax identification number) than the billing entity. The commenter asserted that our attempt to define ``office of the billing physician or other supplier'' results in ``nonsensical situations'' in which the anti-markup provisions do not apply if the diagnostic test is done on a different floor of the same building but do apply if it is done in a different building, even if the two buildings are closer together than the two floors.

Several commenters argued that the ``same building'' test is unworkable and contrary to longstanding CMS policy concerning testing performed in a ``centralized building.'' According to the commenters, the ``same building'' proposal assumes an old-fashioned health care delivery system--that is, that all physician services are still delivered in a single practice location. According to these commenters, given market demands for services in multiple urban, suburban and rural locations, the idea that diagnostic testing services should be provided only in a building where ``substantially the full range'' of other physician services also are provided is anachronistic. The commenters opposed the implementation of the ``same building'' test as it relates to the proposed anti-mark-up provisions due to the alleged economic losses and decreased operating efficiencies that will result. The commenters contended that the fact that the diagnostic equipment is located in a separate building does not support an inference that the diagnostic services are not an integral part of the practice, as our proposal assumes.

Response: Under this final rule, the anti-markup provisions will not apply to the TC or PC of a diagnostic test where the performing physician shares a practice with the billing physician or other supplier. With respect to a TC or PC of a diagnostic testing service, the performing physician is considered to share a practice with the billing physician or other supplier if: (1) He or she furnishes substantially all (at least 75 percent) of his or her professional services through the billing physician or other supplier; or (2) the TC is conducted and supervised, or the PC is performed, in the office of the billing physician or other supplier. We believe that, in the situation where an arrangement would otherwise be subject to the anti- markup payment limitation because the performing physician does not furnish at least 75 percent of his or her professional services through the billing physician or other supplier, services that satisfy the site-of-service approach indicate a sufficient nexus between the performing physician and the billing physician or other supplier. We proposed clarifying that the ``office of the billing physician or other supplier'' protects diagnostic testing that takes place in the ``same building'' (as defined at Sec. 411.351) in which the ordering physician sees patients because, following publication of the CY 2008

PFS final rule with comment period, stakeholders expressed concern that arrangements in which the diagnostic testing takes place on one floor of a building, but the billing physician or other supplier sees patients on another floor, could be subject to the anti-markup provisions. We agree with those stakeholders that it would be unnecessarily disruptive to impose the anti-markup payment limitation on

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those types of arrangements, but we do not believe that it is appropriate to go further and define ``office of the billing physician or other supplier'' as including diagnostic testing space that is in a separate building from where the ordering physician sees patients.

Specifically, we are unwilling to define ``office of the billing physician or other supplier'' as including diagnostic testing space in a ``centralized building'' due to the potential overbreadth of that definition with respect to some arrangements. We also reject a square footage test in lieu of using the ``same building'' definition because the former may be more difficult to enforce and the latter is an already-existing, well-defined concept.

Comment: Several commenters responded to our solicitation for comments that would describe current business arrangements, such as those that take place on a ``campus,'' and that would suggest any additional or alternative criteria to permit such arrangements to avoid application of the anti-markup provisions. We received a few comments suggesting that we exempt arrangements taking place on a campus, and suggesting criteria for how we would define ``campus.'' For example, one commenter suggested that, to be considered ``on campus,'' the diagnostic center/building/entity must be located within the main building(s), or located in the physical area immediately proximate to the provider's main building(s). Alternatively, the commenter suggested, the diagnostic testing could be performed in other areas or buildings that are not proximate to the main building(s) but which are fully integrated (that is, financially integrated and administered in concert with overall operations standards, guidelines, rules and directives), with governance and operations functions determined by central administrative processes and structures. Another commenter encouraged us to consider the ``office of the billing physician or other supplier'' to encompass all buildings on a campus or within a multi-campus organization and the area of the entire legally-owned organization, regardless of where the service is performed. Another commenter noted that physician practices currently are required to list each practice location with the Part B carrier, and asserted that, because of this, there is adequate information for CMS (through the carrier) to monitor the campus arrangement to assure that the geographic layout of the physician practice is a bona fide campus.

Response: We believe that, at this time, providing a definition of

``campus'' that would be both workable for the industry yet address our concerns of potential overutilization would be difficult and may add unnecessary complexity to the final rule. We believe that the commenters' concerns will be alleviated by allowing arrangements to satisfy the requirements of either the Alternative 1 or the Alternative 2 approach, as revised.

Comment: A commenter questioned whether we intended ``ordering physician'' to mean an individual physician or any physician in the group. According to the commenter, in many specialty groups, a particular ordering physician will work at only one location, but the diagnostic services are provided at another location, where other physicians in the same group and in the same specialty provide substantial physician services. The commenter asserted that, if we mean that, in order to avoid application of the anti-markup payment limitation, a specific individual physician must provide the substantial physician services in that particular location where the diagnostic services are provided, the proposal would render unprofitable many existing lawful arrangements for single-specialty practices with multiple locations. The commenter further asserted that our proposal would require physicians in multi-practice locations to rearrange schedules so as to rotate through practice locations where the diagnostic testing services are provided.

One commenter contended that the focus on where the ordering physician regularly furnishes care will affect all physician groups where all the physicians are not located in the same building and diagnostic testing services are only offered in a few of the group's locations. According to the commenter, the physician self-referral law requires a group practice with multiple locations to function as one group, and group practices have structured their arrangements to meet existing governmental requirements and to serve patients. The commenter asserted that changing these requirements may make it impossible for some groups to continue to provide these services to Medicare beneficiaries.

Response: We believe that the commenters' concerns that physician practices with multiple locations will not be able to meet the ``site- of-service'' approach are adequately addressed by allowing billing physicians and other suppliers to comply with either the requirements of Alternative 1 or Alternative 2.

Comment: A commenter requested that the definition of ``office of billing physician or other supplier'' be modified to include a mobile van that is used in the parking lot of a building in which the physician group sees patients. Otherwise, the commenter argued, the use of mobile MRI essentially will be barred. According to the commenter, physician groups that use mobile MRI on an exclusive basis because of the nature of their practices are not committing any abuse that we should address in the anti-markup provisions. Another commenter noted that alternative 2, as proposed, would not allow groups to operate mobile diagnostic testing services performed in mobile vehicles, vans or trailers because they are specifically excluded from the definition of ``same building'' at Sec. 411.351.

Response: We are not modifying the definition of the ``office of the billing physician or other supplier'' to include a mobile van that is used in the parking lot of a building in which the physician group sees patients. ``Same building,'' as defined at Sec. 411.351 of the physician self-referral regulations, specifically excludes a mobile vehicle, van, or trailer. Therefore, unless provided in a mobile unit that qualifies as a ``centralized building'' (as defined at Sec. 411.351), diagnostic services provided in the parking lot of a building in which a physician group sees patients already would be subject to the physician self-referral restrictions and would not be protected under the in-office ancillary services exception. In the January 4, 2001 Phase I final rule with comment period, we discussed our specific reasons for declining to include within the definition of ``same building'' a mobile van or other unit (66 FR 889 through 892). We are concerned with the potential for confusion if we were to have one definition of ``same building'' for physician self-referral purposes and another, more expansive definition for purposes of applying the anti-markup payment limitation. Moreover, we decline to expand the definition of ``same building'' for purposes of applying the anti- markup provisions given the potential we see for overutilization through arrangements that take place outside the ``same building.''

Again, arrangements that do not satisfy the requirements of the

Alternative 2 ``site-of-service'' approach may fit under the requirements of the Alternative 1 ``substantially all'' professional services approach. g. Services Performed at a Site Other Than the Office of the Billing

Physician or Other Supplier

Comment: A commenter offered strong support for the proposed

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clarification that ``if the TC is conducted outside the office of the billing physician or other supplier, the anti-markup provision applies irrespective of whether the supervision takes place in the office of the billing physician or other supplier.'' The same commenter also supported our proposal that the anti-markup payment limitation would apply if ``either the conducting of the TC or the supervising of the TC takes place outside the office of the billing physician or other supplier.'' Another commenter supported the proposed change that the anti-markup payment limitation would apply if the TC is either conducted or supervised outside the office of the billing physician or other supplier in order to eliminate confusion among providers when determining whether the TC is deemed to be provided by an outside supplier for purposes of the anti-markup provisions. Another commenter expressed concern that the TC will be considered to be performed outside the office of the billing supplier if the physician is not in the office when the test is being performed. According to the commenter, this runs counter to long standing Medicare regulation and policy regarding the supervision of diagnostic tests, as many of these tests do not require physician presence during the performance of the test. The commenter argued that changing this, requiring physicians to be present, would only inflate healthcare costs.

A commenter recommended that TCs and PCs of non-purchased items performed outside the office of the billing physician or other supplier not be subject to the anti-markup provisions, noting that many audiologists are self-employed and perform testing services for off- site physicians. The commenter further asserted that audiology services do not require physician supervision, and per CMS transmittal 84

(issued February 29, 2008 and effective April 1, 2008), these services are to be billed by the provider of the service and benefits reassigned to the employer. The commenter contended that there has been no evidence of abuse with respect to billed audiology services, so no change is warranted.

Response: We are adopting our proposal that, for purposes of satisfying the requirements of Alternative 2 with respect to the TC, the TC must be both conducted and supervised in the office of the billing physician or other supplier. Although the requirement that the supervising physician be present in the office of the billing physician or other supplier may be more restrictive than some Medicare coverage and payments regulations governing supervision of tests, we believe that our amendment to Sec. 414.50(a)(2)(iii) is necessary in order to minimize the potential for overutilization and program abuse. We do not believe that healthcare costs would be inflated if physicians were required to be present in the office of the billing physician or other supplier. If the test was not conducted within the office of the billing physician or other supplier, and/or the physician supervision did not occur within the office of the billing physician or other supplier, the service would still be payable by Medicare.

We recognize that where audiologist services are performed by an audiologist, no physician supervision is necessary, and therefore the anti-markup provisions do not apply (because Sec. 414.50 applies to tests performed by a physician). We note further, however, that the TC of some audiological tests can be conducted by a technician and supervised by a physician, in which case, the anti-markup provisions potentially are applicable to the TCs and PCs of such tests. Although the commenter stated that there is no evidence of abuse with respect to billed audiology services, we are not required to demonstrate that fraud or abuse has occurred in order to finalize our proposals, but rather we attempt to guard against the potential for overutilization or patient abuse, and we strive to make distinctions between specific types of diagnostic services only when there is a persuasive reason to do so. We are unpersuaded to make such a distinction here. As noted above at section II.N.2., and as discussed more fully below at section

II.N.2.h. in response to a comment, we are deleting references to purchased TCs and PCs from Sec. 414.50.

Comment: Commenters expressed concern that the anti-markup provisions would apply when cardiologists perform the PC of a diagnostic testing service procedure in a hospital or other facility, as is often the case for complex or high risk procedures, because the test is conducted outside the office of the billing physician.

Commenters asserted that cardiology groups that provide outreach services in rural areas and are the only providers of certain cardiac subspecialty services in such areas are concerned that their provision of hospital-based cardiac diagnostic tests to rural patients could become financially impossible under the anti-markup provisions, thereby reducing access to care for this already underserved population.

Response: We do not expect the anti-markup payment limitation would apply in the situation described by the commenter, because, under

Alternative 1 as finalized in this final rule with comment period, the performing cardiologist likely would share a practice with the cardiology group billing for the PC (or would be billing for the PC himself or herself). If the cardiologist reassigns payment to the hospital which then bills for the PC, the anti-markup payment limitation would not apply because the hospital did not order the PC. h. Definition of Outside Supplier

Comment: We proposed that the TC of a diagnostic test is not purchased from an outside supplier if the TC is both conducted and supervised in the office of the billing physician or other supplier and the supervising physician is an employee or independent contractor of the billing physician or other supplier. (For ease of reference, we refer to this below as the ``primary proposed definition''.) In the alternative, we proposed that: (1) If the TC is conducted by a technician who is not an employee of the billing supplier, the TC is considered to be purchased from an outside supplier, regardless of where the technician conducts the TC, and notwithstanding the employment status of the supervising physician and the fact that the test is supervised in the office of the billing physician or other supplier; and (2) where the TC is conducted by a non-employee of the billing physician or other supplier and outside the office of the billing physician or other supplier, the TC nevertheless will not be considered a purchased test if the supervising physician is an employee or independent contractor of the billing physician or other supplier and performs the supervision in the office of the billing physician or other supplier. Several commenters offered support of the primary proposed definition of outside supplier. One such commenter also requested that the final rule make clear that, for anti-markup purposes only, the performing supplier with respect to the TC would be the physician who supervised the TC, even when the technician is not an employee of the billing physician or other supplier.

One commenter supported the first alternative proposed definition of outside supplier. This commenter suggested that the physician organization should be permitted to mark up the TC only if the technician is an employee and the supervising physician is on-site and is also an employee of the billing physician or physician organization.

One commenter

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supported adoption of the second alternative proposed definition. The commenter expressed its view that this definition provides sufficient flexibility to ensure that the anti-markup provisions will not be applied unless there is an inadequate relationship between the individual who performs or supervises the test and the billing entity.

Response: As explained above at II.N.2., we are deleting from Sec. 414.50 purchased tests and interpretations from an ``outside supplier'' as separate bases for imposing an anti-markup payment limitation. After reviewing the comments, we have concluded that employing the concept of a purchased TC or PC as a separate basis for imposing an anti-markup payment limitation is unnecessary, redundant, and potentially confusing in light of our decision to finalize Alternative 1 and to allow arrangements that do not meet the requirements of Alternative 1 to avoid application of the anti-markup provisions if they meet, on a case-by-case basis, the requirements of Alternative 2. If we were to adopt any of our proposals for the definition of ``outside supplier,'' it would mean we would effectively impose an anti-markup payment limitation on some arrangements that meet the ``substantially all'' services requirement of Alternative 1. We believe that a physician who performs ``substantially all'' of his services through a particular billing physician or other supplier ``shares a practice'' not only within the meaning of Alternative 1, but also within the meaning of section 1842(n)(1) of the Act. Moreover, although we considered adopting the second proposed alternative definition of ``outside supplier'' so that a TC would not be a purchased test if the supervising physician is an employee or independent contractor of the billing physician or other supplier and performs the supervision in the office of the billing physician or other supplier (regardless of the employment status of the technician or where the technician conducts the test), this too would be problematic in light of our decision to adopt Alternative 1 but also allow arrangements that do not meet the requirements of Alternative 1 to avoid application of the anti-markup provisions by meeting, on a case-by-case basis, the site-of-service criteria of Alternative 2. That is, with respect to arrangements that do not meet the requirements of Alternative 1 and thus must meet the site-of-service requirements of Alternative 2, adopting our second alternative definition of ``outside supplier'' would have been superfluous because, under Alternative 2, the TC must be both conducted and supervised within the office of the billing physician or other supplier. We retain the requirement, present in all of the proposed definitions of ``outside supplier,'' that the physician must be an employee or independent contractor of the billing physician or other supplier by incorporating the requirement into the Alternative 2 criteria. Similarly, we believe that an anti-markup payment limitation on purchased PCs is unnecessary with respect to diagnostic testing services that meet the requirements of Alternative 2, because we are adding the requirement to Alternative 2 that the physician performing the PC is an employee or independent contractor of the billing physician or other supplier. Thus, as finalized, we are deleting the references in Sec. 414.50 to purchased tests and interpretations from an outside supplier. As finalized, the anti-markup payment limitation will apply to TCs and PCs that meet neither the requirements of

Alternative 1 nor Alternative 2, without regard to whether the TC or PC was purchased from an outside supplier.

Comment: A commenter requested that we clarify our use of the term

``conducted or supervised'' because a physician may ``supervise'' an imaging procedure, for instance, even though he or she is not necessarily the physician who will be interpreting a test. According to the commenter, Medicare's determination as to the level of supervision required for a specific test supports this conclusion. The commenter stated that a CT scan, for instance, when performed without contrast requires only general supervision, whereas the same test performed with contrast requires direct supervision. The commenter asserted that this difference is due to the relative levels of medical risk to a patient during a test, not the interpretation of results. The commenter requested that we clarify that a ``supervising'' physician need not be the physician responsible for interpreting test results or images.

Response: The commenter is correct that the supervising physician need not be the physician responsible for interpreting test results or images.

Comment: For purposes of the anti-markup payment limitation only, we proposed to define the ``performing physician'' with respect to the

TC as the physician who supervised the TC and, with respect to the PC, as the physician who performed the PC. One commenter supported this proposal, but requested several clarifications. The commenter understood the proposal to mean that the performing supplier of the TC is the physician who supervised the TC rather than the technician who actually conducted the test. The commenter inquired whether, if the anti-markup provision were applied in this instance, the group could recover only the fees it paid to the physician for the TC and not any amounts paid directly to the histotechnologist who furnished the TC.

The commenter also requested clarification regarding application of the rule where a group purchases the TC directly from an outside supplier or histotechnologist, without any physician involvement.

Response: The commenter is correct in that the performing supplier of the TC is the physician who supervised the TC. Where the anti-markup payment limitation applies, the billing physician or other supplier may bill for the lowest of the following amounts: (1) The performing supplier's net charge to the billing physician or other supplier; (2) the billing physician or other supplier's actual charge; or (3) the fee schedule amount for the test that would be allowed if the performing supplier billed directly. With respect to the commenter's question regarding whether a TC purchased from a supplier ``without any physician involvement,'' as noted in this section II.N.2.h., we have deleted the references to purchased tests or interpretations from an

``outside supplier.'' The anti-markup payment limitation will apply if a TC is supervised by a physician who does not, within the meaning of

Alternative 1, share a practice with the billing physician or other supplier and the TC does not meet the site-of-service requirements of

Alternative 2 (that is, the TC was not conducted in the ``office of the billing physician or other supplier'' or was not supervised in the

``office of the billing physician or other supplier'' by a physician who is an owner, employee, or contractor of the billing physician or other supplier). If the TC does not require physician supervision under our rules, the anti-markup provisions are inapplicable. i. Specific Solicitation of Comments

(1) Net Charge

Comment: We stated that we were interested in receiving comments concerning the calculation of the ``net charge'' when the anti-markup provisions apply (73 FR 38548). In response, many commenters expressed concern that we did not propose to allow practices to which the anti- markup provisions apply to recoup at least their direct practice costs where the practice is limited to billing Medicare its ``net charge'' for the testing

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service. One commenter asserted that if a group provides diagnostic tests at a site other than the ``office of the billing physician or other supplier,'' the calculation of a net charge is difficult and punitive because a group practice cannot consider all of the actual components of costs incurred, thereby compelling the group practice to lose money. Another commenter argued that it is ``grossly unfair'' to not allow physicians to recover any overhead costs. The commenter further contended that, although we may be concerned about physicians who may ``pad'' their charges with illegitimate amounts, this does not justify penalizing providers who incur appropriate and often costly overhead costs. According to the commenter, it would go against well- established Medicare policy to not allow physicians to include legitimate costs in calculating a net charge. Another commenter stated that many suppliers would incur a loss, not just fail to profit, if these ``confusing and hyper-technical rules'' are adopted. For example, the commenter asserted, a billing physician would be prohibited from billing for the costs incurred when a technician performs the TC of a test because the physician group may bill only for the cost of the physician who supervised the test. The commenter also stated that the proposal effectively prohibits the payment for qualified technicians in the performance of the TC of diagnostic tests, or, in the alternative, requires that physicians who choose to provide their patients with such tests do so at a loss.

One commenter explained that it is common practice for physician groups to provide pathologists with office space, equipment, administrative services, billing and collection services, and other services and then bill for the PC itself. The commenter urged that net charges should be defined to include these overhead costs rather than just the amount the physician group pays the pathologist to perform the

PC. According to this commenter, it is critical that physicians be able to recoup actual and readily allocable costs attributable to these services. If they cannot, the commenter predicted, gastroenterology groups will be forced to stop utilizing their labs for Medicare- reimbursed services, and patient care will suffer.

Another commenter suggested that we allow a group practice to include in the calculation of ``net charge'' actual additional incremental costs incurred by the group which are directly allocable to the provision of the service, for example, rental charges for a facility used exclusively to provide diagnostic tests. If billing or administrative staff are hired by the group solely to provide billing services related to the provision of diagnostic tests, such costs should appropriately be considered in calculating net charge. The commenter contended that requiring that such costs be associated exclusively with providing the diagnostic tests for which payment is sought will ensure that only costs actually needed to provide the tests are included in the calculation of net charge. The commenter further asserted that this will permit groups to provide better diagnostic health care services for their clients without losing substantial money on every test performed.

A commenter stated that, without a proposed definition for ``net charge,'' it did not understand how the anti-markup provisions could be applied fairly and consistently to testing provided by physician groups. The commenter stated that physician groups have standard fees for diagnostic test components that they charge to patients and payers and that, in order to determine an ``inside'' charge the group's usual and customary external charges would have to be recognized. According to the commenter, a fair net charge calculation would need to include the cost of equipment, supplies, technical personnel, related benefits, and allocated space, utilities, taxes and general overhead, which vary between practitioners.

Another commenter stated that there should not be an allowance made to recover overhead expenses, such as billing expenses, rental charges, or equipment expenses, as these expenses will only help underwrite the cost of the laboratory and will be contrary to the goal of reducing overutilization. According to this commenter, the only costs that should be included in the calculation of ``net charge'' are those directly paid to the pathologist performing the PC or supervising the

TC and should be limited to the W-2 salary income of the pathologist, not including any bonus.

Response: After considering the issue further, we decline at this time to make any changes to what we allow to be included in the calculation of ``net charge.'' As we stated in the preamble to the CY 2008 PFS final rule (72 FR 66319 through 66320), we are concerned that, allowing billing physicians and other suppliers to recoup costs such as overhead in situations in which the anti-markup provisions apply, would undermine a purpose of the anti-markup payment limitation because the incentive to overutilize (to recover capital outlays and other costs) would still be present. Therefore, where the billing physician or other supplier pays the performing supplier a fixed fee for the TC or the PC, the ``net charge'' is the fixed fee (exclusive of any charge that is intended to reflect the cost of equipment or space leased to the performing supplier by or through the billing physician or other supplier, per Sec. 414.50(a)(2)(i)). Where a fixed fee is not paid, the billing physician or other supplier is limited to the salary and benefits it paid to the performing supplier for the TC or PC. As we indicated in the CY 2008 PFS final rule, it is the responsibility of the billing entity to ascertain the amount it paid for the TC or PC.

The billing entity should maintain contemporaneous documentation of the methodology and information used to calculate the net charge, and may do so in any reasonable manner (72 FR 66318).

(2) Direct Billing

Comment: In the CY 2009 PFS proposed rule, we solicited comments on whether, in addition to or in lieu of the anti-markup provisions, we should prohibit reassignment in certain situations and require the physician supervising the TC or performing the PC to bill Medicare directly (73 FR 38548). One commenter opposed any requirement that a physician performing either the TC or the PC of diagnostic tests directly bill for such services. The commenter stated that the Congress enacted the anti-markup provisions in section 1842(n) of the Act rather than adopt the already established direct billing requirement for clinical laboratory services. The commenter argued that we should not second-guess the Congress' decision and choose to eliminate the system of assignment and reassignment that is currently in place. Another commenter agreed with the first commenter and stated that reassignment is beneficial to both physicians and patients because physicians gain flexibility to establish the most appropriate employment or contractual relationships for their lives and lifestyles and patients benefit by having medical services combined on one bill, which avoids confusion and additional paperwork. A commenter opposed to direct billing stated that, with respect to the situation in which multiple suppliers are engaged in the treatment of a patient, a prohibition on reassignment would force suppliers to bill Medicare directly only for the services provided directly by each supplier, resulting in a doubling of the claims that are submitted, with an increase in billing expenses. The commenter asserted that this prohibition would also be a concern for

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locum tenens physicians who are, by agency definition, independent contractors. According to the commenter, it does not have the infrastructure to submit and collect payments from Medicare, and thus its contracts are based on the ability to reassign its Medicare claims to the physician or practice it is supporting.

Some commenters were in favor of direct billing, stating that itemized billing encourages transparency relative to the amounts paid for the TC and PC of tests ordered by the billing physician or group.

The commenters stated that an itemized bill would identify the PC and

TC providers, the services provided, and associated charges as separate line items on a single Medicare claim form. The commenters further asserted that we would be able to reconcile TC and PC components without an increase in billing expenses to either the providers or

Medicare. One commenter expressed its view that the most straightforward way to address potential overutilization caused by physicians being able to profit by billing for diagnostic services performed by others would be to implement a direct billing requirement.

The commenter suggested that this would be a simple, understandable, bright-line rule that could be effectively implemented and monitored.

Another commenter supported the establishment of direct billing for anatomic and clinical pathology services for all payers, public and private, so that payment should be made only to the person or entity that performed or supervised the service, except for referrals between laboratories independent of a physician's office. According to this commenter, this policy would be consistent with ethics principles that discourage fee-splitting.

Response: We appreciate the comments on whether, in addition to or in lieu of the anti-markup provision, we should prohibit reassignment in certain situations and require the physician supervising the TC or performing the PC to bill Medicare directly. The issues raised and the suggestions made by the commenters will be taken into consideration for purposes of future rulemaking. As we noted above in section II.N.2.a., we agree that it would be simpler to adopt the approach, as suggested by one commenter, that we not allow any reassignment of diagnostic testing services and, instead, require direct billing. However, without studying that approach further, we have concerns that doing so may unnecessarily prevent nonabusive arrangements.

(3) Effective Date

Comment: In the CY 2009 PFS proposed rule, we solicited comments on whether revisions made by the CY 2008 PFS final rule with comment period (but which were delayed until January 1, 2009 through a final rule published on January 3, 2008 (73 FR 404)) should go into effect on

January 1, 2009, and whether any proposals from the CY 2009 PFS proposed rule that we may finalize should go into effect on that date, or whether some or all of the revisions should be delayed past January 1, 2009. One commenter urged us to implement the anti-markup provisions without delay, as we have been studying this issue since 2004. The commenter asserted that sufficient time has passed for consideration of comments on the issue. The commenter also expressed its view that the anti-markup payment limitation will not affect access to critical patient services, only the ability of ordering providers to profit from their referrals.

One commenter suggested an effective date of July 1, 2009, to provide sufficient time to restructure affected relationships. Another commenter, opposed to the anti-markup proposals, suggested that, if we revise the provisions currently in effect, the new provisions should not be effective until December 31, 2010 at the earliest. The commenter asserted that such a delay would ensure providers a reasonable amount of time to restructure their service and billing arrangements for consistency with the new provisions.

Another commenter asserted that the delayed portions of last year's rule should not go into effect on January 1, 2009, and that neither of the alternative approaches discussed in this year's proposal should be finalized. The commenter stated that we achieved our goal of regulating so-called ``pod labs,'' and asserted that extending similar rules based on site-of-service beyond the pathology laboratory context risks disruption to a wide variety of diagnostic testing services that are genuinely ``inside'' group practices. Commenters claimed that these proposals have made it virtually impossible for physician practices or suppliers potentially subject to these rules to plan for compliance or alternative arrangements by January 1, 2009. One commenter requested that, if we do proceed with the extension of the anti-markup provision, the effective date of the rule be delayed until regulatory language can be proposed for each of the alternatives under consideration and there has been additional time to understand the impact of each proposal.

A commenter recommended that we delay beyond January 1, 2009, the application of any further revisions until we can fully evaluate the effect of such revisions on physician groups and work with the medical community to simplify and streamline the anti-markup provisions, so that their application is clear to all involved. One commenter requested that we consider delaying the proposals until further evaluation is completed on the impact of recent changes affecting physicians such as MIPPA, DRA, ``Bottom-Up Methodology'' and the proposed IDFT requirements. Another commenter recommended that implementation should be delayed and that we should use the process set forth by the Congress in MIPPA to establish accreditation requirements for medical imaging to assess the appropriate use of imaging services and to examine the perceived overutilization of in-office imaging. A commenter recommended that we defer to the Congress regarding concerns of overutilization of diagnostic testing services. According to the commenter, the directives in MIPPA, released after the current proposed rule, are much clearer on this issue. The commenter noted that the

Congress did not amend the anti-markup provision, choosing instead to direct the agency to develop a demonstration project to determine the appropriateness of advanced diagnostic imaging services furnished to

Medicare beneficiaries and require accreditation of advanced diagnostic imaging suppliers by 2012.

Response: We do not agree with the commenters that suggested a delayed effective date beyond January 1, 2009 for either the revisions made by the CY 2008 PFS final rule with comment period or the revisions that we are making in this CY 2009 PFS final rule with comment period.

We have decided to make the finalized revisions effective as of January 1, 2009. When we delayed, until January 1, 2009, the application of the revisions to Sec. 414.50 we made in the CY 2008 PFS final rule with comment period (except with respect to certain diagnostic testing arrangements involving anatomic pathology performed in a ``centralized building'' for which the revisions were applicable January 1, 2008), we stated that we planned to issue clarifying guidance as to what constitutes the ``office of the billing physician or other supplier'' within the following 12 months (73 FR 405). We proposed the clarification and other revisions in the CY 2009 PFS proposed rule in order to introduce the possible changes under consideration.

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The revisions being finalized in this regulation stem from that proposal and we believe that sufficient time has been given for consideration of and response to the anti-markup revisions.

Irrespective of whether ``pod lab'' arrangements otherwise would continue to exist or proliferate, we believe that the anti-markup provisions are needed in order to address potential program and patient abuse through the ordering of unnecessary diagnostic tests. Although several commenters made mention of MIPPA and the impact that it may have, we are not swayed by these arguments. MIPPA is a separate authority with a different focus than that of the anti-markup provisions. If, in the future, the anti-markup provisions are impacted through our implementation of MIPPA, we will address this in subsequent rulemaking. j. Miscellaneous

Comment: One commenter, a professional association of pathologists, suggested an exception from the anti-markup provisions for single- specialty pathology physician groups and independent laboratories. The commenter suggested that such entities be defined as those in which all physicians within the group are pathologists and for which 75 percent of all CPT codes billed by the entity are pathology and laboratory CPT codes. According to the commenter, such an exception would ``clarify'' that dedicated pathology groups and independent laboratories are not subject to the anti-markup provisions for certain purchased diagnostic tests and interpretations or the ordering of special stains to perform better the tests ordered by outside, independent physicians. The commenter asserted that its proposed exception would be consistent with the physician self-referral's exclusion from the definition of

``referral'' for services ordered by pathologists (and radiologists and radiation oncologists) pursuant to a consultation with another physician. According to the commenter, the exclusion from the definition of ``referral'' reflects the Congress's recognition that services ordered by such physicians pursuant to a consultation with another physician do not pose the same risk of abuse that physician self-referral generally poses. The commenter also suggested an alternative to its proposed exception, for independent laboratories for which at least 75 percent of the diagnostic tests have been ordered by physicians outside the laboratory. A second commenter representing pathologists also suggested an exception for pathology practices (which it would define as any entity for which at least 75 percent of all CPT codes billed by the entity are pathology and laboratory codes). The commenter also cited the exclusion from the definition of ``referral'' in the physician self-referral rules for services ordered by pathologists pursuant to a consultation, and asserted that there should not be a self-referral or mark-up concern when pathology groups order special stains or other tests. A third commenter stated that the

``rapid rise'' in special stains in the last eight years is not a result of in-office pathology services or TC/PC arrangements, but rather is a result of the failure of national, regional, and hospital- based pathology laboratories to follow standard protocol for tissue biopsies. The commenter contended that over-utilization of anatomic pathology testing can be managed by imposing tighter controls on such laboratory-based pathologists with respect to what stains they order and the reasons for ordering them.

Response: We are not establishing an exception that would be applicable to pathology practices or independent laboratories, to the anti-markup provisions. We note that we did not propose such an exception and, thus, question whether we would have the authority to provide for such an exception in this final rule. Moreover, we are not convinced of the need for or wisdom of such an exception. We believe that the same potential that exists for the overutilization of diagnostic tests ordered by single-specialty physician groups and other suppliers, due to the profit motive, also exists for the ordering of special stains or other tests by pathology groups or independent laboratories.

Comment: An association that represents physician group practices suggested that we establish a multi-specialty medical group ``carve out'' for ``merit,'' that is, an exemption from the anti-markup provisions based on delivery of high-quality health care services in the multi-specialty/organized system of care model. According to the commenter, the potential and risk for inappropriate actions is outweighed by the attributes and meritorious actions of multi-specialty groups. The commenter noted that, in section 131 of MIPPA, the Congress recognized the coordinated approach to patient care that multi- specialty medical groups provide.

A different commenter requested that multi-specialty group practices not be permitted to use the employment or independent contractor arrangements to bring pathology services in-house and then claim that a referral is exempt from the physician self-referral prohibition because it meets the requirements of the in-office ancillary services exception or some other exception. The commenter stated that pathology is a separate physician specialty and the provision of these services is not ancillary to the provision of urology or gastroenterology. According to the commenter, pathology services provided in-office do not serve the patient's convenience or increase access to these services as they are too time consuming and complex to perform, as the patient has always left the doctor's office by the time the pathology examination is complete and the report issued. The commenter argued that not allowing pathology services to be protected by the in-office ancillary services exception would be consistent with the physician self-referral law and would eliminate the incentive for overutilization that currently exists.

Response: For the same reasons expressed in the response to the previous comment, we are not establishing an exception to the anti- markup payment limitation, for multi-specialty groups. We also note that because we have adopted the first proposed alternative with modification, whereby the anti-markup provisions will not apply to TCs and PCs supervised or performed by a physician who performs

``substantially all'' of his or her professional services for the billing physician or other supplier, ``hub and spoke'' arrangements of multi-specialty groups should not have significant difficulty avoiding application of the anti-markup provisions. We understand the commenter's concerns about the use of the in-office ancillary services exception and may propose rulemaking on this issue in the future.

Comment: A commenter stated that dermatologic surgeons who order and read their own diagnostic tests should not be penalized for doing so by the addition of new and overly cumbersome regulations that the commenter argued are inconsistent with the existing physician self- referral law. According to the commenter, a dermatopathologist has the expertise to diagnose and monitor diseases of the skin, which entails the examination and interpretation of specially prepared tissue sections, cellular scrapings, and smears of skin lesions by means of routine and special (electron and fluorescent) microscopes. The commenter was also concerned that patient access to care in rural and underserved areas will be affected. The commenter urged that practices that

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order and interpret their own diagnostic tests in these areas should have the same ability to recoup the costs of equipment, space, and medical records management for services performed within their practices as those practices that utilize an outside supplier for the

TCs or PCs of their tests.

Response: We are unclear as to what the commenter is suggesting. We did not propose to, and this final rule does not, impose tighter billing restrictions on TCs and PCs ordered by dermatologic surgeons than for other specialties, and does not impose tighter billing restrictions for dermatologic surgeons who perform TCs and PCs than it does for those physician practices that purchase TCs and PCs from an outside supplier. We note that the commenter did not provide an explanation of why patient access to care in rural or underserved areas would be affected by our proposed revisions.

Comment: A letter writing campaign expressed concern regarding the proposals to the anti-markup provisions, contending that it would limit the ability of allergists to provide services on a part-time basis with more than one group and, in particular, would limit access to allergy care (including allergy diagnostic tests), to Medicare beneficiaries in rural or underserved areas. The commenters urged that our proposals not be implemented.

Response: We have adopted the first proposed alternative with modification, whereby the anti-markup provisions will not apply to TCs and PCs supervised or performed by a physician who performs

``substantially all'' (at least 75 percent) of his or her professional services for the billing physician or other supplier, which provides some flexibility for the performing physician to work for more than one billing physician or other supplier. Moreover, this final rule provides additional flexibility by allowing arrangements that do not come within the protection of the ``substantially all'' test to avoid the application of the anti-markup payment limitation by complying on a case-by-case basis with the existing site-of-service approach (as clarified by this final rule with comment period). We believe that this addresses the commenters' concerns.

O1. Physician Quality Reporting Initiative (PQRI) a. Program Background and Statutory Authority i. Division B of the Tax Relief and Health Care Act of 2006--Medicare

Improvements and Extension Act of 2006 (MIEA-TRHCA) and the Medicare,

Medicaid, and SCHIP Extension Act of 2007 (MMSEA): Requirements for the

PQRI Program Prior to Enactment of the Medicare Improvements for

Patients and Providers Act of 2008 (MIPPA)

Section 101(b) of the MIEA-TRHCA (Pub. L. 109-432) amended section 1848 of the Act by adding subsection (k). Section 1848(k)(1) of the Act requires the Secretary to implement a system for the reporting by eligible professionals of data on quality measures as described in section 1848(k)(2) of the Act. Section 1848(k)(1) of the Act authorizes the Secretary to specify the form and manner for data submission by program instruction or otherwise which may include submission of such data on Part B claims. Section 1848(k)(3)(B) of the Act specifies that for the purpose of the quality reporting system, eligible professionals include physicians, other practitioners as described in section 1842(b)(18)(C) of the Act, physical and occupational therapists, and qualified speech-language pathologists. Section 101(c) of the MIEA-

TRHCA, as amended by the Medicare, Medicaid, and SCHIP Extension Act of 2007 (Pub. L. 110-173) (MMSEA), authorizes ``Transitional Bonus

Incentive Payments for Quality Reporting'' in 2007 and 2008, for satisfactory reporting of quality data, as defined by section 101(c)(2) of the MIEA-TRHCA. We have named this quality reporting system the

``Physician Quality Reporting Initiative (PQRI)'' for ease of reference.

The MMSEA required the Secretary to establish alternative reporting periods and alternative criteria for satisfactorily submitting data on quality measures through medical registries and for reporting groups of measures for 2008 and 2009.

For 2009, section 1848(k)(2)(B)(ii) of the Act, as amended by the

MMSEA, requires the Secretary to publish a proposed set of quality measures that would be appropriate for eligible professionals to use to submit data in 2009 in the Federal Register by August 15, 2008. Such measures shall be measures that have been endorsed or adopted by a consensus organization, such as the National Quality Forum (NQF) or the

AQA (formerly the Ambulatory Care Quality Alliance), that include measures that have been submitted by a physician specialty, and that the Secretary identifies as having used a consensus-based process for developing such measures. In addition, the measures shall include structural measures, such as the use of electronic health records

(EHRs) and electronic prescribing (e-prescribing) technology. The

Secretary must publish the final set of measures in the Federal

Although section 101(c) of the MIEA-TRHCA, as amended by the MMSEA, authorized the Secretary to make incentive payments for satisfactorily reporting quality measures data on covered professional services furnished by eligible professionals during the reporting period for 2007 and 2008, neither MIEA-TRHCA nor MMSEA authorized an incentive payment for PQRI for 2009. Also unlike the 2007 or 2008 PQRI, neither the MIEA-TRHCA nor the MMSEA defined a specific reporting period for the 2009 PQRI. ii. Extension of and Enhancements to the PQRI Program Authorized by the

MIPPA

The MIPPA, which was enacted after the publication of the CY 2009

PFS proposed rule, included a number of provisions that impact the 2009

PQRI. Prior to enactment of the MIPPA, the MIEA-TRHCA, as amended by the MMSEA, was the authorizing legislation for PQRI. The MIPPA codifies the PQRI under sections 1848(k)(2) and 1848(m) of the Act. First, the

MIPPA makes the PQRI a permanent program and authorizes us to make incentive payments for satisfactorily reporting data on quality measures for covered professional services furnished by eligible professionals during the 2009 PQRI reporting period equal to 2.0 percent of the estimated total allowed charges for all covered professional services furnished during the reporting period that are submitted no later than 2 months after the end of the reporting period.

In addition, the reporting period for the 2009 PQRI is defined as the entire year, or January 1, 2009 through December 31, 2009. Therefore, for the 2009 PQRI, eligible professionals who satisfactorily report data on quality measures for covered professional services furnished between January 1, 2009 through December 31, 2009 will receive an incentive payment equal to 2.0 percent of the total estimated allowed charges submitted by no later than February 28, 2010 for all covered professional services furnished between January 1, 2009 and December 31, 2009.

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Beginning with the 2009 PQRI, the MIPPA also amended the definition of ``eligible professional'' to include qualified audiologists (as defined in section 1861(11)(3)(B) of the Act). Thus, for purposes of the 2009 PQRI, eligible professionals include physicians, other practitioners as described in section 1842(b)(18)(C) of the Act, physical and occupational therapists, qualified speech-language pathologists, and qualified audiologists.

In addition, section 1848(k)(2)(D) of the Act, as added by the

MIPPA, requires that for each 2009 PQRI quality measure, ``the

Secretary shall ensure that eligible professionals have the opportunity to provide input during the development, endorsement, or selection of measures applicable to services they furnish.''

Section 1848(m)(3)(A) of the Act, as amended and redesignated by the MIPPA, also requires that for years after 2008, the PQRI quality measures shall not include e-prescribing quality measures. Even with the removal of the e-prescribing measure, we continue to meet the requirements under section 1848(k)(2)(B)(ii) of the Act to include the use of structural measures.

Section 131(b)(6) of the MIPPA also specifies that none of the amendments to the Social Security Act resulting from the MIPPA will impact the operation of the PQRI for 2007 or 2008. Additional information regarding the MIPPA provisions can be found in section III of this final rule with comment period. iii. General Program Comments and Responses

In the CY 2009 PFS proposed rule (73 FR 38558 through 38559), we provided a longer summary of the history of the PQRI and a more detailed discussion of the pertinent MIEA-TRHCA and MMSEA requirements than is provided above in this section. We proposed to define the 2009

PQRI reporting period to be the entire CY 2009, but also proposed alternative reporting periods and alternative criteria for satisfactorily reporting quality measures data for measures groups and registry-based reporting as required by the MMSEA (73 FR 38559 through 38564). The CY 2009 PFS proposed rule (73 FR 38564 through 38565) also included proposed reporting options and reporting periods for satisfactorily reporting quality measures data extracted from EHRs.

To satisfy section 1848(k)(2)(B) of the Act, as amended by the

MMSEA, we published 175 proposed 2009 PQRI quality measures in the CY 2009 PFS proposed rule (73 FR 38565 through 38572). We also proposed 9 measures groups for the 2009 PQRI on which eligible professionals may report (73 FR 38572 through 38574) and described potential uses of the

PQRI information (73 FR 38574 through 38575).

In the CY 2009 PFS proposed rule (73 FR 38558 through 38575), we solicited comments on the following areas:

Implications of including or excluding any given measure from the set of proposed 2009 quality measures.

The new measures groups proposed for 2009 including suggestions for other measures groups based on individual measures included in the proposed 2009 PQRI measure set.

The proposed use of the consecutive patient reporting criteria for measures groups.

The proposed use of 30 consecutive patients as the required sample under the consecutive patient reporting criteria during the full-year 2009 reporting period.

The proposed options and planned use of registries for registry-based quality measures results and numerator and denominator data on quality measures data reporting to PQRI in 2009.

The advisability of expanding the number of PQRI quality measures beyond the 119 measures in the 2008 PQRI quality measure set given that there is no specific authorization for an incentive payment for the 2009 PQRI and beyond.

Various issues that we identified in the proposed rule to help us determine the most appropriate uses of PQRI data.

We received 161 comments from the public on the CY 2009 PFS proposed rule related to the PQRI. In this section of the final rule with comment period, we first summarize the comments about the PQRI program in general and our responses to those comments immediately below. The remaining comments received and our responses to those comments are discussed under the relevant topic areas of this section of the final rule with comment period.

Comment: Several comments commended CMS and the PQRI program for providing more flexibility and were generally supportive of the program including the proposed addition of measures in the 2009 PQRI and the continued development and implementation of a variety of reporting periods and reporting methodologies.

Response: We appreciate the commenters' positive feedback.

Comment: Several commenters suggested that we conduct an independent, formal evaluation of the PQRI program's processes and to analyze and validate the data that has been gathered to date. One of the major reasons cited for needing an evaluation component was the fact that a relatively small percentage of those eligible professionals who participated in the 2007 PQRI actually received an incentive payment. Other common reasons cited include to assess the range of specialties reporting information to ensure that most eligible professionals have the opportunity to participate, to better understand why some eligible professionals did not participate, and to fully understand how improvements affect participation rates prior to expansion of the PQRI.

Response: We are continuing to evaluate the results of the 2007

PQRI and will evaluate the results of the 2008 PQRI as they become available as we develop and implement strategies for enhancing the PQRI in the future.

Comment: A number of commenters also offered to assist us in improving physician quality measure design and to help us better understand the barriers to and the stimuli for participating by requesting to review the data files used for calculating the 2007 and/ or 2008 incentive payments.

Response: Information about individuals that is retrieved by the individuals' names or other personal identifiers is subject to the

Privacy Act of 1974 (that is, the Privacy Act), Freedom of Information

Act and other Federal government rules and regulations. As such, the information cannot be released without the individual's written consent, unless the Privacy Act permits release. See 5 U.S.C. 552a(b).

We employ strict security measures to appropriately safeguard individual privacy and seek to ensure that files containing physician and/or beneficiary identifiers are used only when necessary and in accordance with disclosure provisions of the Privacy Act. The Privacy

Act, as well as the notice that is published in the Federal Register for each CMS System of Records (SOR), provide the permitted disclosures of individually identifiable information and explain the procedures that need to be followed to safeguard the information. The notices that describe each CMS SOR can be found on the CMS Web site at http:// www.cms.hhs.gov/PrivacyActSystemofRecords/SR/list.asp#TopOfPage.

All research requests for individually identifiable data must be submitted to the Research Data Assistance Center (ResDAC) for initial review. More information on the policies and procedures for data requests for data that are protected by the Privacy Act can be found on the CMS Web site at http://www.cms.hhs.gov/

Page 69819

PrivProtectedData/01_Overview.aspTopOfPage.

Comment: Many commenters recommended we redesign the PQRI section of the CMS Web site, including suggestions to provide an updated listing of measures under formal consideration by the various measure developers, as well as to provide more detailed information about the

PQRI measures.

Response: We concur with commenters' suggestions to redesign the

PQRI section of the CMS Web site. We are currently working to make the

Web site more user-friendly and will consider the commenters' suggestions.

Comment: A few commenters suggested we establish a multi- stakeholder advisory council or that we actively engage more stakeholders, such as consumers and hospitals. Active engagement of stakeholders could be used for a variety of purposes, such as to help understand why some eligible professionals may not have participated; to engage and obtain feedback and observations from those who will be measured as well as those who successfully participated; to ensure that the PQRI measures provide clinically-significant information while being structured in the least administratively-burdensome manner possible; or to advise us as we proceed with making information derived from the PQRI publicly available.

Response: We plan to continue our dialogue with the stakeholder community and will consider their and PQRI participants' input as we continue to evaluate the results from the PQRI and to develop and implement strategies for enhancing the PQRI in the future.

Comment: One commenter recommended different incentives that we could employ to increase participation, such as reducing eligible professionals' costs for collecting Medicare payments.

Response: We are bound by statute with respect to the types of incentives that we can provide to eligible professionals, how those incentives are calculated, and the amount of the incentive. The only incentives we are authorized to provide eligible professionals are an incentive for eligible professionals who satisfactorily report quality measures data through the PQRI as discussed below and the new incentive that we are implementing in 2009 for eligible professionals who are successful electronic prescribers as discussed in section II.O2. below.

Comment: Other specific suggestions for improving the PQRI provided by commenters include renaming the PQRI the ``Provider'' or

``Practitioner'' Quality Reporting Initiative to acknowledge potential participation of all types of Medicare providers; separating the quality reporting from the billing process by removing the requirement that ``G'' codes are reported on the same claim as the denominator service; developing guidelines on which measures are appropriate for reporting by different medical specialties; designing reporting options in a manner that would allow smaller providers to more easily participate; considering assigning all measures to clinical area groups; providing an appeal process for eligible professionals who participate but are not deemed to be successful; and ensuring greater transparency in all aspects of the program including, but not limited to, in the measure selection process, in the provision of feedback, and in the implementation of the pertinent MIPPA provisions.

Response: We appreciate and value the constructive feedback that we have received from the wide variety of commenters who have provided insights and information and partnered with us to disseminate information about PQRI. As reflected in the variety of reporting options that we are making available for the 2009 PQRI and the expansion of measures groups, it is our desire to allow as many eligible professionals to participate with as little additional burden as possible. To the extent that we find it practical, feasible, and appropriate to implement the commenters' suggestions, we would do so via notice and comment rulemaking for future years' PQRI.

With respect to the commenters' suggestion to provide an appeals process for eligible professionals who participate but are not deemed to be successful, we note that section 1848(m)(5)(e) of the Act, as amended by MIPPA, provides that with respect to the PQRI there shall be no administrative or judicial review under sections 1869 or 1879 of the

Act, or otherwise of (1) the determination of measures applicable to services furnished by eligible professionals; (2) the determination of satisfactory reporting; and (3) the determination of any incentive payment. Therefore, we have no authority to establish an appeals process for the subject of eligible professionals ``not deemed to be successful'' which we read to fall within the determination of satisfactory reporting.

Comment: We received numerous comments providing general recommendations for enhancing the Medicare program, such as suggestions to transition the PQRI from a pay-for-reporting program to a pay-for- performance program as quickly as possible; addressing problems of underuse, overuse, and misuse of services; assuring that all Americans receive the right care by reducing health care disparities and encouraging that quality care be provided to at-risk populations; encouraging care coordination and support for the integration and delivery of services across providers and across care settings; and providing payment that supports the re-engineering of care, such as providing payment for e-visits and efficiency-enhancing forms of telemedicine. One commenter expressed a desire to see the development of a quality reporting mechanism similar to the PQRI that is applicable to a pediatric population and Medicaid.

Response: While we appreciate these suggestions for enhancing the

Medicare and Medicaid programs mentioned, we note that those programs are beyond the scope of this section of the final rule with comment period. This section of the final rule with comment period is limited to the 2009 PQRI.

Comment: Many commenters also commented on the MIPPA provisions that were not directly related to the PQRI. For example, we received many comments related to the plan for transitioning to a value-based purchasing program for physicians' services that we are required to submit to the Congress by May 1, 2010 under the MIPPA.

Response: While we appreciate the commenters' input for implementing the MIPPA provisions, we note that MIPPA provisions that are not directly related to the PQRI program are beyond the scope of this section of the final rule with comment period. This section of the final rule with comment period is limited to the 2009 PQRI.

Comment: Several commenters expressed confusion about participation requirements and recommended that we implement an aggressive education and outreach campaign on how to successfully participate, to help eligible professionals who did not receive a bonus understand why, and that provides participating eligible professionals with confidential interim and final feedback and compliance reports.

Response: We agree that with increased flexibility comes more potential for confusion about participation requirements. Section 1848(k)(6) of the Act requires the Secretary to provide for education and outreach to eligible professionals on the operation of the PQRI.

To minimize any potential confusion, we have hosted monthly national

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provider calls on the PQRI in which our PQRI subject matter experts are available to answer questions on the PQRI. We have also provided guidance on specific topics on these calls, such as accessing the 2007

PQRI feedback reports, how the 2007 incentive payments were calculated, and the various 2008 reporting options.

In addition to the national provider calls, we have worked with various medical specialty societies, such as the American Academy of

Family Physicians, the American College of Physicians, American Academy of Ophthalmology, American Optometric Association, and the American

Gastroenterological Association Institute to host Special Open Door

Forums to educate their membership on the PQRI. We anticipate continuing these education and outreach activities as we implement the 2009 PQRI.

Information about these CMS-sponsored calls, including information about upcoming calls, can be found on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI. The Web site itself also serves as a useful resource for obtaining the most up to date information on the

PQRI. For example, the PQRI Tool Kit found on the PQRI section of the

CMS Web site at http://www.cms.hhs.gov/PQRI/31_

PQRIToolKit.asp#TopOfPage contains valuable resources to help eligible professionals in the successful integration of PQRI into their practices. We encourage eligible professionals to visit this Web site and to review the frequently asked questions found on this Web site.

Comment: Many commenters stated they were pleased the Congress extended PQRI and authorized a 2.0 percent incentive payment for 2009, but others noted that the incentive payment was not enough to outweigh the burden of participating or noted concern about the number of

``quality and efficiency'' measures imposed on physicians without evidence of improved health outcomes, health status, and reduced system costs. One commenter recommended that we base the incentive payment on

RVUs rather than the amount billed to Medicare.

Response: We do not have the authority to change the basis for calculation of the incentive payment. Section 1848(m)(1) of the Act, as redesignated and amended by the MIPPA, authorizes us to make incentive payments for satisfactorily reporting data on quality measures for covered professional services furnished by eligible professionals during the 2009 PQRI reporting period equal to 2.0 percent of the estimated total allowed charges for all covered professional services furnished during the reporting period that are submitted no later than 2 months after the end of the reporting period. However, we are committed to exploring and supporting practical, effective mechanisms for quality-of-care data submission that promote efficiency by streamlining participants' and our data collection and handling. As such, and as described below in this section of the final rule with comment period, we have developed and are implementing options for registry-based submission of quality measures data and plan to implement options for EHR-based submission of quality measures data after some additional testing.

In addition, we have increased the number of measures groups and individual PQRI quality measures available for the 2009 PQRI in an effort to expand opportunities for eligible professionals to participate in PQRI.

Comment: We received many comments urging us to ensure that all eligible professionals have meaningful opportunities to participate in the PQRI. Some commenters were specifically concerned that funding for the Quality Insights of Pennsylvania (QIP) project to develop nonphysician quality measures has ended and hoped that CMS will continue to extend funding in the future for the development and implementation of quality measures for nonphysicians as well as to move measures already developed by the QIP through the NQF endorsement and/ or AQA approval process.

Several commenters were also concerned that therapists who work in certain outpatient settings (for example, acute care hospitals, skilled nursing facilities, comprehensive outpatient rehabilitation facilities, or rehabilitation agencies) are unable to participate in PQRI since they do not use the 1500 or 837-P claim form and instead submit claims on the UB-04 or 837-I form where there is no place to report the individual National Provider Identifier (NPI) of the eligible professional furnishing the service. The commenters recommended registry-based alternatives for PQRI participation.

A few commenters noted that pathologists who bill via independent laboratories are also not able to participate in the PQRI because we are not yet able to capture this billing situation.

Response: We agree with the goal of providing as many eligible professionals the opportunity to participate in the PQRI as is practical and feasible. As we stated in the CY 2009 PFS proposed rule

(73 FR 36566), one of the considerations we employed in the selection of measures for the 2009 PQRI is to select measures that increase the scope of applicability of measures to services furnished to Medicare beneficiaries and expand opportunities for eligible professionals to participate in PQRI. We seek to increase the circumstances where eligible professionals have at least three measures applicable to their practice.

For the 2008 PQRI, we supported, via contract with QIP, the development of structural measures and measures applicable to a broad cross-section of PQRI eligible professionals, including some NPPs who had few or no measures available in the 2007 PQRI. We prioritized development of these measures available or otherwise in development and on a need to address as broad a cross-section of eligible professions or specialties as possible within the limited volume of measures for which we could support development in time for inclusion in the 2008

PQRI. As the contracted measure developer, QIP was responsible for supporting the measures through the AQA adoption process. CMS funded a project with the NQF which reviewed the measures for endorsement.

We plan to continue working to fill gaps in available consensus endorsed or adopted measures consistent with available time and resources. However, we largely depend on and encourage the development of measures by professional organizations and other measure developers.

Ideally, in the future, there will be a sufficient number of clinician- level quality measures that meet the statutory requirements that CMS would be able to just select PQRI measures from these existing measures rather than needing to fund the development of additional clinician- level quality measures.

Regarding the concerns cited by therapists unable to participate in

PQRI since they do not use the 1500 or 837-P claim form, we note as we did in the CY 2008 PFS final rule with comment period (73 FR 66337) that our analysis of claims-based alternatives to enable participation determined that extensive modifications to the claims processing systems of CMS and providers would be required. Such modifications would represent a material administrative burden to us and providers and/or modifications to the industry standard claims formats, which would require substantial time to effect via established processes and structures that we do not maintain or control.

Our analysis of the two registry-based alternatives suggested by the commenters indicate that it would be possible for therapists in this situation

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to participate in a registry because there are registries ``qualified'' to participate in our 2008 PQRI program that intended to report all of the PQRI measures and that are open to all eligible professionals who would like to participate with them. However, it would not be possible to calculate an incentive payment for the therapists' participation since our claims processing systems do not allow us to attribute services furnished by therapists who bill through fiscal intermediaries to an individual eligible professional to calculate the incentive amount. As required by section 1848(1)(A)(ii) of the Act, as redesignated and added by the MIPPA, the 2009 PQRI incentive must be calculated based on each eligible professional's allowed charges for covered professional services that are based on or paid under the

Medicare PFS. Although we are in the process of evaluating the impact of making the changes to the fiscal intermediary claims processing systems needed to be able to accept the PQRI quality data codes and attribute them to an eligible professional, it is unknown at this time whether these changes can be made without undue burden to our systems or what the timeline for potential implementation would be.

Regarding the concern that pathologists who bill through independent laboratories are unable to participate in the PQRI, we note that only eligible professionals as defined in section 1848(k)(3)(B) of the Act are eligible to participate in PQRI. As discussed in section

II.O1.a.ii. above, ``eligible professional'' is defined to include physicians, other practitioners as described in section 1842(b)(18)(C) of the Act, physical and occupational therapists, qualified speech- language pathologists, and qualified audiologists for the purposes of the 2009 PQRI. As noted in the comment, independent laboratories are suppliers and are therefore not eligible to participate in PQRI.

Pathologists who bill directly to Medicare, however, are eligible to participate in PQRI.

Comment: Several commenters noted the mechanism for viewing the feedback reports was too cumbersome and were concerned about the lack of timely feedback (both in terms of when the feedback reports are received and when incentive payments are received). Several commenters requested that more detailed information be provided in the feedback reports so that eligible professionals can reconcile CMS' data with their own claims information to ensure that codes were submitted accurately, captured by the Medicare Administrative Contractor (MAC), transferred to the PQRI data system, and result in meaningful data that corresponds to the eligible professional's own experience.

Response: Although, as discussed in sections II.SG.6. and III. of this final rule with comment period, section 1848(n) of the Act, as added by the MIPPA, requires the Secretary to establish a Physician

Feedback Program to provide confidential reports to physicians (and, if determined appropriate by the Secretary, groups of physicians) that measure the resources involved in furnishing care to Medicare Part B patients, we are not statutorily required to provide participants with feedback reports on the quality measures data submitted for the PQRI and are not committing to provide feedback reports for claims-based submission of quality measures data for the 2009 PQRI. For registry- based reporting in 2009, we would rely on the participating registries to provide feedback to participating eligible professionals.

We do, however, understand the value of receiving meaningful feedback reports and, to the extent that we continue to provide PQRI participants with feedback reports for claims-based submission of quality measures data for the 2009 PQRI, we will consider such concerns as part of our ongoing dialogue with stakeholders in order to collaboratively identify ways to enhance the program's value to its participants and to the Medicare program. We note though that information on all aspects of care billed to Medicare, including quality data codes, is found on the remittance advice that eligible professionals receive. We urge PQRI participants to review the information received on the remittance advice along with their own records (such as their own claims information) to ensure that PQRI quality information is being accurately submitted and captured on claims. We also note that 2007 was the first broad scale implementation of quality data submission through the claims process. We are aware that practice management systems have the capability to analyze information received on the remittance advice. We anticipate that practice management systems may be adapted in the future for analysis of quality data code submission, as well. Such systems could provide contemporaneous feedback and analysis for physicians.

With respect to the timeframe when incentive payments are received, it is unlikely that we will be able to issue incentive payments for participation in PQRI for a particular year much sooner than the middle of the following year because of the way in which the incentive payments are calculated. The incentive payments are calculated based on the total estimated allowed charges for the reporting period. As required by section 1848(m)(1)(A)(ii) of the Act, as redesignated and added by the MIPPA, we must wait until 2 months after the end of the reporting period to allow eligible professionals to submit claims for covered professional services furnished during the reporting period.

Comment: The MIPPA requires that by January 1, 2010, the Secretary shall establish and have in place a process under which eligible professionals in a group practice shall be treated as satisfactorily submitting data on quality measures for the PQRI. A few commenters welcomed this option and offered to assist CMS in defining ``group practice.'' Another commenter noted that it would be more cost- effective for multi-specialty group practices to participate under this new option.

Response: We welcome the commenters' interest in our plans for implementing future enhancements to the PQRI based on the MIPPA.

However, we note that the scope of this section of the final rule is limited to the 2009 PQRI. Our plans for future years' PQRI, including our plans for implementing the MIPPA provisions that affect future program years, will be discussed in future notice and comment rulemaking. Thus, commenters can expect to see a discussion of our plans for implementing the physician group practice option for the 2010

PQRI in the CY 2010 PFS proposed rule next year. b. Satisfactory Reporting Criteria and Reporting Periods--Reporting

Options in the 2009 PQRI

In the CY 2009 PFS proposed rule (73 FR 38559), we proposed to define the reporting period for the 2009 PQRI as the entire year

(January 1, 2009-December 31, 2009) and proposed two alternative reporting periods for reporting measures groups and for registry-based reporting: (1) January 1, 2009 through December 31, 2009; and (2) July 1, 2009 through December 31, 2009.

As discussed in section III. of this final rule with comment period, the MIPPA defines the reporting period for the 2009 PQRI to be the entire year. Therefore, for the 2009 PQRI the reporting period will be January 1, 2009 through December 31, 2009. We are retaining the two alternative reporting periods, which were unaffected by MIPPA, for reporting measures groups and registry-based reporting (that is,

January 1, 2009 through December 31, 2009 and July 1, 2009 through

December 31, 2009) as proposed. These reporting periods result in several reporting

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options available to eligible professionals that vary by the reporting mechanism selected. The reporting mechanisms and criteria for satisfactorily reporting quality measures data for the 2009 PQRI are described in the following section. i. Claims-Based Submission of Data for Reporting Individual Measures

Under section 1848(m)(3) of the Act, as redesignated and added by the MIPPA, the criteria for satisfactorily submitting data on individual quality measures through claims-based submission require the reporting of at least three applicable measures in at least 80 percent of the cases in which the measure is reportable. If fewer than three measures are applicable to the services of the professional, the professional may meet the criteria by reporting on all applicable measures (that is, one to two measures) for at least 80 percent of the cases where the measures are reportable. It is assumed that if an eligible professional submits quality data codes for a particular measure, the measure applies to the eligible professional. These criteria were proposed for the January 1, 2009 through December 31, 2009 reporting period.

We received a few comments on the proposed reporting period and criteria for satisfactorily submitting quality data through claims for reporting individual measures, as discussed below.

Comment: A few commenters encouraged CMS to establish alternative reporting periods for claims-based submission of individual quality measures. One commenter specifically requested us to extend the alternative reporting period of July 1, 2009 through December 31, 2009 to eligible professionals participating in PQRI through claims-based reporting of individual quality measures. The commenter stated that measures groups and/or registries are not always an option for eligible professionals.

Response: We appreciate the commenter's suggestions, which are intended to enhance the claims-based reporting of individual measures by providing greater flexibility. However, as discussed above and in section III. of this final rule with comment period, the MIPPA defines the reporting period for the 2009 PQRI to be the entire year and, as discussed in section II.O1.a.i. above, the MMSEA authorizes the

Secretary to establish alternative reporting periods for registry-based reporting and for reporting on measures groups only. We note, however, that for years after 2009, the MIPPA authorizes the Secretary to revise the reporting period for claims-based submission of quality measures data if it is determined that such revision is appropriate, produces valid results on measures reported, and is consistent with the goals of maximizing scientific validity and reducing administrative burden.

Additionally, there are registries currently participating in the 2008 PQRI that report or are able to report all of the PQRI quality measures. Alternative reporting periods are available for registry- based submission of quality measures data, which enables all eligible professionals who wish to participate in PQRI to do so through a registry. For the 2008 PQRI, there are 32 registries ``qualified'' to submit quality measure results and numerator and denominator data on quality measures on behalf of eligible professionals.

Based on our review of this comment, we are retaining the reporting option for claims-based submission of data on individual quality measures as summarized in Table 11. That is an eligible professional can meet the criteria for satisfactorily reporting quality data by reporting at least three applicable measures (or one to two measures if fewer than three measures apply) for at least 80 percent of the cases in which each measure is reportable, during January 1, 2009 through

December 31, 2009.

Table 11--Final 2009 PQRI Claims-Based Reporting Options for Individual

Measures

Reporting mechanism

Reporting criteria

Reporting period

Claims-based reporting........ At least 3 PQRI

January 1, 2009- measures, or 1-2

December 31, measures if less than 2009. 3 apply to the eligible professional, for 80 percent of applicable

Medicare Part B FFS patients of each eligible professional.

ii. Satisfactory Reporting of Data on Quality Measures and Reporting

Periods for Measures Groups, Through Claims-Based Reporting and

Registry-Based Reporting

As described in the CY 2009 PFS proposed rule, section 101(c)(5)(F) of the MIEA-TRHCA, as added by the MMSEA and redesignated by the MIPPA as section 1848(m)(5)(F) of the Act, requires that the Secretary establish alternative reporting periods and alternative criteria for satisfactorily reporting groups of measures. In establishing these alternatives, we have labeled these groups of measures ``measures groups.'' We define ``measures groups'' as a subset of PQRI measures that have a particular clinical condition or focus in common. The denominator definition and coding of the measures group identifies the condition or focus that is shared across the measures within a particular measures group.

For the 2009 PQRI, we proposed to expand the available measures groups to a total of nine measures groups. We proposed to carry forward three of the four 2008 measures groups for the 2009 PQRI: (1) Diabetes

Mellitus; (2) Chronic Kidney Disease (CKD); and (3) Preventive Care. In addition, we proposed to add six new measures groups for the 2009 PQRI:

(1) Coronary Artery Bypass Graft (CABG) Surgery;

(2) Coronary Artery Disease (CAD);

(3) Rheumatoid Arthritis;

(4) Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency

Syndrome (AIDS);

(5) Perioperative Care; and

(6) Back Pain.

We proposed to allow measures groups to be reported through claims- based or registry-based submission for the 2009 PQRI.

We proposed that the form and manner of quality data submission for 2009 measures groups would be posted on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/pqri no later than December 31, 2008, and will detail specifications and specific instructions for reporting measures groups via claims and registry-based reporting.

The final 2009 PQRI measures groups and the measures selected for inclusion in each of the 2009 measures groups are listed in section

II.O1.d.v. of this final rule with comment period.

We proposed (73 FR 38561) establishing three options for satisfactorily reporting measures groups using claims-based reporting and three options for satisfactorily reporting measures groups using registry-based

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submission for the 2009 PQRI. We proposed two basic criteria for satisfactory reporting of measures groups for both claims-based submission and registry-based submission. For claims-based reporting, the two criteria were: (1) The reporting of quality data for 30 consecutive Medicare Part B FFS patients for one measures group for which the measures group is applicable during a full-year reporting period; or (2) the reporting of quality data for at least 80 percent of

Medicare Part B FFS patients for whom the measures group is applicable

(with a minimum number of patients commensurate with the reporting period duration). For registry-based submission, the two criteria were:

(1) The reporting of quality measures results and numerator and denominator data for 30 consecutive patients for one measures group for which the measures group is applicable during a full-year reporting period; or (2) the reporting of quality measures results and numerator and denominator data for at least 80 percent of patients for whom the measures group is applicable (with a minimum number of patients commensurate with the reporting period duration).

We proposed that the 30 consecutive patients reporting criteria apply only to the entire year (January 1, 2009 through December 31, 2009) reporting period, but would apply to both claims-based submission and registry-based submission mechanisms.

We proposed that the alternative criteria for measures groups based on reporting on 80 percent of patients for which one measures group would be applicable for the January 1, 2009 through December 31, 2009 reporting period (with a minimum of 30 patients) and to the July 1, 2009 through December 31, 2009 reporting period (with a minimum of 15 patients). These alternative criteria would also be applicable for either claims-based or registry-based reporting of measures groups.

In the CY 2009 PFS proposed rule (73 FR 38561), we requested comments on the proposed use of the consecutive patient reporting criteria and on the use of 30 consecutive patients (for claims-based reporting, the consecutive patients must all be Medicare FFS patients) as the required minimum sample under these criteria during the full- year 2009 reporting period.

We received numerous comments on the proposed alternative reporting periods and alternative criteria for satisfactory reporting of data on measures groups, including the proposed use of the consecutive patient reporting criteria and proposed use of 30 consecutive patients. These comments are summarized and addressed below.

Comment: Some commenters suggested that we establish general rules governing measures groups reporting involving multiple providers from separate entities.

Response: To qualify for the PQRI incentive, each individual professional must separately qualify, based on the criteria for reporting measures groups and the services rendered by the individual professional. The reporting by other professionals and the establishment of rules relating to the reporting of multiple providers from separate entities is not germane to satisfactory reporting at the individual level. Each individual professional must qualify based on that individual's satisfactory reporting. No later than December 31, 2008, we will post the detailed specifications and specific instructions for reporting measures groups at http://www.cms.hhs.gov/ pqri. This document is intended to promote an understanding of how to implement and facilitate satisfactory reporting of quality measures results and numerator and denominator data by individual eligible professionals who wish to participate in PQRI via measures group reporting.

Comment: Many commenters strongly supported the continued use of measures groups, the expansion of measures groups, registry-based submissions of measures groups, and alternative reporting periods for measures groups.

Response: We are pleased that many commenters are supportive of the measures groups concept, the expansion of measures groups, registry- based submissions for measures groups, and alternative reporting periods. These options provide for program efficiency, flexibility and opportunities for physicians and other eligible professionals to more broadly demonstrate their clinical performance for particular services and provide a better basis for comparison among professionals. We plan to continue a dialogue with stakeholders to discuss opportunities for program efficiency and flexibility.

Comment: Many commenters were in support of the 30 consecutive patient reporting option for the full year 2009 reporting period. One commenter noted that a sample consisting of consecutive patients would result in a nonrandom sample of patients. Another commenter requested clarification on which 30 patients should be included in the consecutive patient sample.

Response: We are pleased that many commenters found the 30 consecutive patient reporting option to be useful and were supportive of this option. We agree that a sample of 30 consecutive patients would be a nonrandom sample, but it is our intention to allow physicians and other eligible professionals greater flexibility and opportunities to participate in PQRI. In addition, requiring consecutive patients would prevent eligible professionals from being able to selectively report cases to enhance their performance rates.

While we do not have the results of the 2008 PQRI reporting, we believe that a minimum sample size of 30 consecutive patients is sufficient to calculate comparable performance rates across eligible professionals furnishing comparable services. Patient sample sizes of 30 are commonly considered to be a reasonable minimum threshold for being able to reliably report health care performance measurement results. Results from our Better Quality Information for Medicare

Beneficiaries (BQI) pilot project indicate that minimum patient sample sizes of between 30 through 50 patients per physician are needed to make reliable distinctions between physicians' performance. (Delmarva

Foundation for Medical Care. Enhancing Physician Quality Performance

Measurement and Reporting Through Data Aggregation: The BQI Project.

October 2008.) We expect additional experience with PQRI reporting to clarify optimal sample sizes and reporting criteria for use in future reporting periods. We will continually evaluate our policies on sampling and notify the public through future notice and comment rulemaking if we make substantive changes. As we evaluate our policies, we plan to continue a dialogue with stakeholders to discuss opportunities for program efficiency and flexibility.

As described in Table 12, for claims-based reporting of measures groups, eligible professionals wishing to report data on measures groups using the consecutive patient criteria should include only

Medicare Part B FFS patients in the consecutive patient sample. For registry-based reporting of measures groups, eligible professionals wishing to report data on measures groups using the consecutive patient criteria may include some non-Medicare FFS patients. However, there must be more than one Medicare Part B FFS patient included in this patient sample as well.

Comment: We received a large volume of comments in support of discontinuing the 15 consecutive patients for a 6-month reporting period

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(that is, July 1 through December 31). We also received a few comments suggesting we continue the option of allowing eligible professionals to report data on 15 consecutive patients for a 6-month reporting period.

Response: Unlike in the 2008 PQRI, we will not include a reporting option for 15 consecutive patients for a 6-month reporting period.

While we do not have the results of the 2008 reporting, we are concerned that samples of fewer than 30 consecutive patients may be insufficient to calculate comparable performance rates across eligible professionals furnishing comparable services. We expect additional experience with PQRI reporting to clarify optimal sample sizes and reporting criteria for use in future reporting periods.

Comment: We received comments recommending that, regardless of the reporting mechanism selected, the criteria for satisfactorily reporting data on measures groups and individual quality measures be expanded to include the reporting data on measures groups and/or individual quality measures for 100 percent of patients for whom the measures group and/or individual quality measures are applicable. One commenter thought that we should specifically require eligible professionals who report via registries to report on 100 percent of their eligible patients. Another commenter suggested that for the option to report on 80 percent of patients for registry-based reporting of measures groups we accept quality measures results and numerator and denominator data on quality measures on all patients, regardless of payer, rather than quality measures results and numerator and denominator data on quality measures on Medicare Part B FFS beneficiaries only. The commenter, however, opposed requiring a minimum number of Medicare FFS patients be included in the data submitted from the registry. Another commenter thought that registry reporting and claims-based reporting requirements should be the same.

Response: While we would encourage eligible professionals to report data on measures groups and/or individual quality measures for all patients who qualify for a measure they are reporting and eligible professionals are not precluded from reporting data on measures groups and/or individual quality measures for 100 percent of their eligible patients, satisfactory reporting was established by the MIEA-TRHCA to include reporting in at least 80 percent of the cases for which the respective measure is reportable. Analysis of the 80 percent reporting threshold has indicated it to be a sufficiently large sample size to be representative of an eligible professional's patient population. That is, 80 percent is a sufficiently large reporting rate that the performance rates calculated from the 80 percent sample are substantially the same as the performance rates calculated from 100 percent of applicable cases. Although a 100 percent sample of cases for which individual quality measure or measures groups are applicable would eliminate any sampling error, requiring 100 percent reporting of applicable cases would cause eligible professionals to be ineligible for an incentive payment based on a failure to report data on a single missed case that falls into the quality measure's denominator.

Additionally, the 80 percent reporting criteria for individual quality measures is statutorily required through 2009 for individual quality measures reported through claims. While the Secretary is authorized to establish a different reporting threshold for measures groups and registry-based reporting, we believe that it is necessary and desirable to maintain consistency and to achieve a balance amongst the reporting options in order to promote a successful program.

With respect to requiring a minimum number of Medicare Part B FFS patients in the sample for registry-based reporting options for reporting on measures groups for at least 80 percent of applicable cases, our primary interest is in improving the quality of care

Medicare beneficiaries receive. If we do not specify a minimum number of Medicare Part B FFS on which eligible professionals should report, it is feasible that an eligible professional could meet the 80 percent threshold by treating just one or two beneficiaries. Thus, for those eligible professionals who treat few Medicare beneficiaries, the sample size would be too small to do any meaningful analysis of the eligible professional's performance on that particular measure even though the sample consists of 80 percent of the eligible professional's Medicare beneficiaries to whom the measure applies.

Comment: One commenter suggested that registries ``facilitate quality measures reporting for measures groups reporting regardless of the relationship of the reporting provider to the registry.'' The commenter suggested that we further clarify that in order to become qualified to submit quality measures results and numerator and denominator data on quality measures to the PQRI on behalf of eligible professionals, a registry must assure a mechanism by which multiple providers who collectively report the individual measures comprising a measures group can do so and that there are no barriers to the reporting of such information by any provider regardless of the provider's relationship to the registry.

Response: Registries provide an alternative to claims-based reporting. Regardless of the reporting mechanism (that is, claims or registries), there is no provision for reporting by multiple professionals under the PQRI since each individual eligible professional must separately meet the criteria for satisfactory reporting of PQRI quality measures. Registries have no responsibility to establish a relationship with any particular professional. An eligible professional who does not have a relationship with a qualified registry has the option of submitting data on measures groups through claims or establishing a relationship with a qualified registry unless he or she wishes to report the CABG surgery measures group. The measures in the CABG surgery measures group are reportable only through a registry.

Comment: One commenter thought we should allow satisfactory reporting of measures groups via registries to count for 2 years of

PQRI reporting.

Response: Our statutory authority authorizes an annual PQRI program. For each year, there are established specific reporting periods and reporting criteria. The incentive payment for PQRI must be for covered professional services furnished during a given reporting period. We do not have the authority to allow satisfactory reporting of measures groups via registries for a 1-year reporting period to count as satisfactory reporting for another year or reporting period.

Based on the comments received, we are finalizing the six options proposed for satisfactorily reporting on measures groups as described in Table 12. The details of the requirements for registries are contained in section II.O1.b.iii.

Continued on page 69825

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

]

pp. 69825-69874

Medicare Program; Payment Policies Under the Physician Fee

Schedule and Other Revisions to Part B for CY 2009; E-Prescribing

Exemption for Computer-Generated Facsimile Transmissions; and Payment for Certain Durable Medical Equipment, Prosthetics, Orthotics, and[Page 69825]

Continued from page 69824

Page 69825

Table 12--Final 2009 PQRI Reporting Options for Measures Groups

Reporting mechanism

Reporting criteria

Reporting period

Claims-based reporting........ One Measures Group for January 1, 2009- 30 Consecutive

December 31,

Medicare Part B FFS

2009.

Patients.

Claims-based reporting........ One Measures Group for January 1, 2009- 80 percent of

December 31, applicable Medicare

2009.

Part B FFS patients of each eligible professional (with a minimum of 30 patients during the reporting period).

Claims-based reporting........ One Measures Group for July 1, 2009- 80 percent of

December 31, applicable Medicare

2009.

Part B FFS patients of each eligible professional (with a minimum of 15 patients during the reporting period).

Registry-based reporting...... One Measures Group for January 1, 2009- 30 Consecutive

December 31,

Patients. Patients

2009. may include, but may not be exclusively, non-Medicare patients.

Registry-based reporting...... One Measures Group for January 1, 2009- 80% of applicable

December 31,

Medicare Part B FFS

2009. patients of each eligible professional

(with a minimum of 30 patients during the reporting period).

Registry-based reporting...... One Measures Group for July 1, 2009- 80% of applicable

December 31,

Medicare Part B FFS

2009. patients of each eligible professional

(with a minimum of 15 patients during the reporting period).

While claims are submitted to CMS on Medicare patients only (for claims-based reporting), the 30 consecutive patients option for registry-based submission for the January 1, 2009 through December 31, 2009 reporting period may include some, but may not be exclusively, non-Medicare patients. We include this limited option to report quality measures results and numerator and denominator data on quality measures that includes non-Medicare patients for registry-based submission because of the desirability of assessing the overall care provided by a professional rather than just that provided to a certain subset of patients, and the benefit of having a larger number of patients on which to assess quality. iii. Registry-Based Submission for Reporting Individual Measures

As discussed in the CY 2009 PFS proposed rule (73 FR 38562), section 101(c)(5)(F) of the MIEA-TRHCA, as added by MMSEA and redesignated by the MIPPA as section 1848(m)(5)(F) of the Act, requires us to establish alternative criteria for satisfactorily reporting PQRI quality measures data through medical registries. For 2009, we proposed that eligible professionals would be able to report 2009 PQRI quality measures results and numerator and denominator data on quality measures through a qualified clinical registry by authorizing or instructing the registry to submit quality measures results and numerator and denominator data on quality measures to CMS on their behalf (73 FR 38562). Similar to the 2008 PQRI, we proposed (73 FR 38562) that the data to be submitted for the 2009 PQRI would include the reporting and performance rates on PQRI measures or PQRI measures groups, as well as the numerators and denominators for the reporting rates and performance rates.

For the 2009 PQRI, we proposed (73 FR 38562) to continue the PQRI reporting criteria for satisfactorily reporting through registry-based submission of 3 or more individual PQRI quality measures data that are described in the ``2008 PQRI: Establishment of Alternative Reporting

Periods and Reporting Criteria'' document (http://www.cms.hhs.gov/PQRI/

Downloads/2008PQRIalterrptperiods.pdf). That is, we proposed to accept quality measures results and numerator and denominator data on quality measures from registries that qualify as data submission vendors. We proposed that these criteria would be available for each of the two alternative reporting periods.

We also proposed (73 FR 38563) to require registries to complete a self-nomination process based on meeting specific technical and other requirements to submit on behalf of eligible professionals pursuing incentive payment for reporting clinical quality information on services furnished during 2009 for reporting both on individual measures and measures groups. We proposed that this self-nomination would be required regardless of whether or not the registry participated in any way in PQRI in 2008 (73 FR 38563).

In the CY 2008 PFS proposed rule (73 FR 38564), we requested comments on the proposed options for registry-based PQRI reporting of data on measures and measures groups for services furnished in 2009. We received several comments on the proposed options for registry-based

PQRI reporting of data on measures and measures groups for services furnished in 2009. Comments related to the proposed options for registry-based PQRI reporting of data on measures groups were summarized and addressed above in section II.O1.b.ii of this final rule with comment period. A summary of the comments received related to our proposed use of registries and the proposed options for registry-based

PQRI reporting of data on individual quality measures and our responses to those comments are discussed below.

Comment: We received numerous comments in support of continuing to allow registries to report quality measures results and numerator and denominator data on quality measures to CMS on behalf of eligible professionals who submit quality data to them. Some commenters thought permitting registry reporting would allow us to better track patient outcomes by looking at results over a period of time rather than only track processes of care and that registry reporting is less burdensome.

Additionally, one commenter suggested we allow those registries that were ``qualified'' to report to PQRI in 2008 be ``qualified'' to report to PQRI in 2009.

Response: For the 2009 PQRI, we are finalizing our proposal to accept quality measures results and numerator and denominator data on quality measures from registries as described in the

Page 69826

proposed rule (73 FR 38562 through 38564). The specifications and qualifications for registries to participate in the 2009 PQRI will be listed on the PQRI section of the CMS Web site at http:// www.cms.hhs.gov/pqri under the reporting tab, by November 15, 2008.

Based on the commenter's suggestion that registries that were

``qualified'' to report to PQRI in 2008 be ``qualified'' to report to

PQRI in 2009, registries that were ``qualified'' for 2008 will not need to be ``re-qualified'' for 2009 unless they are unsuccessful at submitting PQRI data for 2008 (that is, fail to submit 2008 PQRI data per the 2008 PQRI registry requirements). By March 31, 2009, registries that were ``qualified'' for 2008 and wish to continue to participate in 2009 should indicate their desire to continue participation for 2009 and their compliance with the 2009 PQRI registry requirements using the process described below.

If a qualified 2008 registry is unsuccessful at submitting 2008

PQRI data (that is, fails to submit 2008 PQRI data per the 2008 PQRI registry requirements), the registry will need to go through the full qualification process similar to the qualification process that took place for the 2008 PQRI. By March 31, 2009, registries that are unsuccessful submitting quality measure results and numerator and denominator data for the 2008 PQRI will need to be able to meet the specifications listed below and in the document on the Web site and send a letter of self-nomination to us.

Registries that were not qualified for the 2008 PQRI will need to be able to meet the specifications listed below and in the document on the Web site and send a letter of self-nomination to us by January 31, 2009.

Comment: One comment supported registry use if they were open to all providers.

Response: We assume that by ``providers'' the commenter was referring to eligible professionals. As we stated previously, registry reporting is voluntary. There are ``qualified'' registries in our 2008

PQRI program that intend to report all of the PQRI measures. These registries are accepting eligible professionals who wish to sign up as new clients of the registry and are open to all eligible professionals who would like to participate with them. There may be costs associated with participating through registries but this is outside of the purview of PQRI.

We note that although registries are not required to report all

PQRI measures, eligible professionals who wish to report PQRI quality measures data through registries are required to report on at least 3 quality measures when reporting on individual quality measures or to report all measures in at least one measures group when reporting on measures groups. Thus, the eligible professional is responsible for ensuring that the registry that he or she selects has the ability to report the measures that the eligible professional intends to report for PQRI.

Comment: We received one comment requesting eligible professionals with only 1 or 2 measures to be able to report via registries.

Response: We did not propose to allow registry reporting of 1 or 2 measures if less than 3 measures apply. Analytically it would be difficult to implement in that if an eligible professional submits fewer than 3 measures via registries, we would not know whether the eligible professional did so because only 2 measures applied or because the registry only accepts data for 2 of the provider's measures and he or she is reporting their third measure via claims. The amount of cross-checking via different submission options that would be necessary makes it impractical to implement the commenter's suggestion.

Comment: A few comments were received regarding the process for correcting data that was sent in via registries that is incorrect.

Response: We highly discourage eligible professionals from changing data once it is submitted to CMS from the registry. Allowing data to be resubmitted for one or more professionals would not only be time- consuming and delay reports and payment, but it could also result in duplicating or erroneously leaving out some professionals' quality measures results and/or numerator and denominator data on quality measures.

Comment: Two commenters requested that we specify what constituted an acceptable validation strategy for registries.

Response: As a result of the MMSEA, which was enacted in December 2007, and modified the PQRI, we implemented registry-based submission for the 2008 PQRI. Thus, for 2008, we required registry vendors to supply CMS with their validation strategy that would detail how the registry would ensure that the data the registry reported to CMS was accurate. We found that there are several variations for this process that registries use. We do not believe we have enough experience with registries to specify a single validation strategy that all should employ and we believe we are benefited from allowing a variety of such techniques to be employed based on our approval at this point.

Therefore, for the 2009 PQRI, registry vendors will again be required to supply us with their validation strategy that details how the registry would ensure that the data the registry reports to us is accurate. In addition, we note that registries are required to sign an attestation statement to CMS vouching for the accuracy of the data that they submit to CMS on behalf of their eligible professionals.

As we gain more experience with registry submission, we would expect to further specify through rulemaking qualification requirements for registries that may include more comprehensive validation requirements. As we evaluate our policies, we plan to continue a dialogue with stakeholders to discuss opportunities for program efficiency and flexibility.

Comment: One commenter requested that the registry record layout and requirements be published by December 31, 2008. Similarly, many commenters requested that the registry record layout and requirements be published in this final rule with comment period.

Response: We intend to have the requirements posted on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/pqri by November 15, 2008. However, the technical specifications (that is, specifications for the XML file format that registries would need to use to submit PQRI quality measures results and numerator and denominator data on quality measures to CMS) are not finalized and will be made available to a registry after the registry passes an initial qualification process. This will prevent registries that cannot satisfy the requirements listed on the Web site from expending resources trying to meet the technical specifications. Meeting only the technical specifications would not in and of itself qualify the registry to participate.

Comment: A commenter requested that CMS work with standards development organizations to align our measures and specifications for registries and EHRs with the standards development organizations' standards.

Response: We agree with the commenter's suggestion and do actively interact with standards development organizations. We desire to use such standards when available and to promote the adoption and use of such standards.

Based on the comments received, the 2009 reporting options for registry-based submission of at least three individual PQRI measures are finalized as proposed and are listed in Table 13.

Page 69827

Table 13--Final 2009 PQRI Registry-Based Submission Reporting Options for Individual Measures

Reporting mechanism

Reporting criteria

Reporting period

Registry-based reporting...... At least 3 PQRI

January 1, 2009- measures for 80% of

December 31, applicable Medicare

2009.

Part B FFS patients of each eligible professional.

Registry-based reporting...... At least 3 PQRI

July 1, 2009- measures for 80% of

December 31, applicable Medicare

2009.

Part B FFS patients of each eligible professional.

As discussed in section II.O1.b.ii. of this final rule with comment period, we are also establishing the three reporting options for registry-based submission of quality measures results and numerator and denominator data on PQRI measures groups summarized in Table 12.

To report quality measures results and numerator and denominator data on quality measures or measures groups through registries, eligible professionals will need to enter into and maintain an appropriate legal arrangement with an eligible clinical registry. As we described in the CY 2009 PFS proposed rule (73 FR 38562), such arrangements will provide for the registry's receipt of patient- specific data from the eligible professional and the registry's disclosure of quality measures results and numerator and denominator data on behalf of the eligible professional to CMS for the PQRI. Thus, the registry would act as a Health Insurance Portability and

Accountability Act of 1996 (Pub. L. 104-191) (HIPAA) Business Associate and agent of the eligible professional. Such agents are referred to as

``data submission vendors.'' Such ``data submission vendors'' would have the requisite legal authority to provide clinical registry data on behalf of the eligible professional to the Quality Reporting System developed in accordance with the statute. The registry, acting as such a data submission vendor, will submit registry-derived measures information to the CMS designated database within the Quality Reporting

System, using a CMS-specified record layout.

To maintain compliance with applicable statutes and regulations, including but not limited to the HIPAA, our program and its data system must maintain compliance with HIPAA requirements for requesting, processing, storing, and transmitting data. Eligible professionals that conduct HIPAA covered transactions also must maintain compliance with the HIPAA requirements.

To submit on behalf of eligible professionals pursuing incentive payment for reporting clinical quality information on services furnished during 2009 for reporting both on individual measures and measures groups, registries that were ``qualified'' for 2008 will not need to be ``re-qualified'' for 2009 unless they are unsuccessful at submitting 2008 PQRI data (that is, fail to submit 2008 PQRI data per the 2008 PQRI registry requirements). Registries that were

``qualified'' for 2008 and wish to continue to participate in 2009 should indicate their desire to continue participation for 2009 by submitting a letter indicating their continued interest in being a PQRI registry for 2009 and their compliance with the 2009 PQRI registry requirements by March 31, 2009. Such letters should be sent to: 2009

PQRI Registry Nomination, Centers for Medicare & Medicaid Services,

Office of Clinical Standards and Quality, Quality Measurement and

Health Assessment Group, 7500 Security Blvd., Mail Stop S3-02-01,

Baltimore, MD 21244-1850.

If a qualified 2008 registry is unsuccessful at submitting 2008

PQRI data (that is, fails to submit 2008 PQRI data per the 2008 PQRI registry requirements), the registry will need to go through the full self-nomination process again. By March 31, 2009, registries that are unsuccessful submitting quality measure results and numerator and denominator data for 2008 will need to be able to meet the specifications listed in this final rule with comment period and in the document on the Web site and send a letter of self-nomination to the above address. Registries that were not ``qualified'' for 2008 will need to be able to meet the specifications listed in this final rule with comment period and in the document on the Web site and send a letter of self-nomination to the above address by January 31, 2009.

As we stated in the CY 2009 PFS proposed rule (73 FR 38563), we will make every effort to ensure that registries that are ``qualified'' will be able to successfully submit quality measures results and numerator and denominator data on PQRI quality measures or measures groups, but we cannot assume responsibility for the successful submission of data on PQRI quality measures or measures groups, by the registry.

The 2009 registry technical requirements will be posted on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/pqri by November 15, 2008. In general, to be considered qualified to submit individual quality measures on behalf of professionals wishing to report under the 2009 PQRI, a registry must:

Have been in existence as of January 1, 2009.

Be able to collect all needed data elements and calculate results for at least three measures in the 2009 PQRI program (according to the posted 2009 PQRI Measure Specifications).

Be able to calculate and submit measure-level reporting rates by NPI/Taxpayer Identification Number (TIN).

Be able to calculate and submit measure-level performance rates by NPI/TIN.

Be able to separate out and report on Medicare Fee for

Service (Part B) patients only.

Provide the Registry name.

Provide the Reporting period start date (covers dates of services from).

Provide the Reporting period end date (covers dates of services through).

Provide the measure numbers for the PQRI quality measures on which the registry is reporting.

Provide the measure title for the PQRI quality measures on which the registry is reporting.

Report the number of eligible instances (reporting denominator).

Report the number of instances of quality service performed (numerator).

Report the number of performance exclusions.

Report the number of reported instances, performance not met (eligible professional receives credit for reporting, not for performance).

Be able to transmit this data in a CMS-approved XML format.

Comply with a secure method for data submission.

Submit an acceptable ``validation strategy'' to CMS by

March 31, 2009. A validation strategy ascertains whether eligible professionals have submitted accurately and on at least the minimum number (80 percent) of their eligible patients, visits, procedures, or episodes for a given measure. Acceptable validation strategies often include such provisions as the registry being able to conduct random sampling of their

Page 69828

participants' data, but may also be based on other credible means of verifying the accuracy of data content and completeness of reporting or adherence to a required sampling method.

Enter into and maintain with its participating professionals an appropriate legal arrangement that provides for the registry's receipt of patient-specific data from the eligible professionals, as well as the registry's disclosure of quality measure results and numerator and denominator data on behalf of eligible professionals who wish to participate in the PQRI program.

Obtain and keep on file signed documentation that each NPI whose data is submitted to the registry has authorized the registry to submit quality measures results and numerator and denominator data to

CMS for the purpose of PQRI participation. This documentation must meet the standards of applicable law, regulations, and contractual business associate agreements.

Provide CMS access (if requested) to review the Medicare beneficiary data on which 2009 PQRI registry-based submissions are founded.

Provide the reporting option (reporting period and reporting criteria) that the eligible professional has satisfied or chosen.

Registries must provide CMS an ``attestation statement'' which states that the quality measure results and numerator and denominator data provided to CMS are accurate and complete.

In addition to the above, registries that wish to submit 2009 quality measures information on behalf of their participating eligible professionals seeking to participate in the 2009 PQRI based on satisfying the criteria applicable to reporting of measures groups must be able to:

Indicate whether each eligible professional within the registry who wishes to submit PQRI using the measures groups will be doing so for the 6- or 12-month period.

Base reported information only on patients to whom services were furnished during the 12-month reporting period of January through December 2009 or the 6-month reporting period of July 2009 through December 2009.

Agree that the registry's data may be inspected by CMS under our health oversight authority if non-Medicare patients are included in the consecutive patient group.

Be able to report data on all of the measures in a given measures group and on either 30 consecutive patients from January 1 through December 31, 2009 (note this consecutive patient count must include some Medicare Part B FFS beneficiaries) or on 80 percent of applicable Medicare Part B FFS patients for each eligible professional

(with a minimum of 30 patients during the January 1, 2009 through

December 31, 2009 reporting period or a minimum of 15 patients during the July 1, 2009 through December 31, 2009 reporting period).

If reporting consecutive patients, provide the beginning date of service that initiates the count of 30 consecutive patients.

Be able to report the number of Medicare Fee for Service patients and the number of Medicare Advantage patients that are included in the consecutive patients reported for a given measures group.

Registries that were ``qualified'' for 2008 and wish to continue to participate in 2009 must indicate their compliance with the above requirements for 2009 at the time that they indicate their desire to continue participation for 2009.

We will provide the technical specifications (that is, specifications for the XML file format that registries would need to use to submit PQRI quality measures results and numerator and denominator data on quality measures to CMS) to registries after a registry passes an initial qualification process for the 2009 PQRI.

This will prevent registries that cannot satisfy the requirements listed on the Web site from expending resources trying to meet the technical specifications. Meeting only the technical specifications would not in and of itself qualify the registry to participate. iv. EHR-Based Submission for Reporting Individual Measures

In addition to the testing of registry-based submission, we also described in the CY 2009 PFS proposed rule (73 FR 38564 through 38565) our plans to test the submission of clinical quality data extracted from EHRs for five 2008 PQRI measures and proposed to accept PQRI data from EHRs and to pay the incentive payment based on that submission for a limited subset of the proposed 2009 PQRI quality measures.

We proposed to begin accepting submission of clinical quality data extracted from EHRs on January 1, 2009 or as soon thereafter as is technically feasible, based upon our completion of the 2008 EHR data submission testing process and our determination that accepting data from EHRs on quality measures for the 2009 PQRI is practical and feasible. We proposed in the CY 2009 PFS proposed rule (73 FR 38564) that the date on which we will begin to accept quality data submission on services furnished in 2009 would depend on having the necessary information technology infrastructure components and capacity in place and ready to accept data on a scale sufficient for national implementation of PQRI submission through this mechanism.

We proposed that EHR vendors that would like to enable their customers to submit data on PQRI that is extracted from their customers' EHRs to the CMS-designated clinical warehouse should update or otherwise assure that their EHR products capture and can submit the necessary data elements identified for measure specifications and technical specifications for EHR-based submission. We proposed that we would use Certification Commission for Healthcare Information

Technology (CCHIT) criteria and the Healthcare Information Technology

Standards Panel (HITSP) interoperability standards where possible and we encouraged vendors to do so also. We encouraged the use of EHRs that have been certified by the CCHIT for data submission, but recognized that there would be some eligible professionals who are using systems in specialties for which there are no appropriate CCHIT certified EHR systems, or who purchased and implemented their EHR prior to the availability of CCHIT certification.

We proposed as criteria for satisfactory submission of data for quality measures for covered professional services by EHR-based submission for the 2009 PQRI the same criteria for satisfactory reporting and the same reporting period that we proposed for claims- based submission of data for individual 2009 PQRI measures. The proposed reporting criteria for EHR-based submission of individual PQRI measures are summarized in Table 14.

Page 69829

Table 14--Proposed 2009 PQRI EHR-Based Submission Reporting Options for

Individual Measures

Reporting mechanism

Reporting criteria

Reporting period

EHR-based reporting........... At least 3 PQRI

January 1, 2009- measures, or 1-2

December 31, measures if less than 2009. 3 apply to the eligible professional, for 80% of applicable

Medicare Part B FFS patients of each eligible professional.

In the CY 2008 PFS proposed rule (73 FR 38565), we invited comments on the proposed use of EHR-based data submission for PQRI. We received numerous comments on the proposed use of EHR-based data submission for

PQRI, which are summarized and addressed below.

Comment: We received many comments in favor of accepting quality measures data through EHRs in 2009. These commenters cited EHRs as a means for increasing PQRI participation and being able to report more accurate data. There were a few commenters who, while favoring EHR data submission in general, thought that it was premature to begin this process in 2009.

Response: We proposed to begin EHR data submission for PQRI in 2009 based on anticipation that we would have sufficient testing completed to be confident that systems would be in place and operational by

January 1, 2009. At this point, the testing process is incomplete. As a result, we agree with the commenter's suggestion that it is premature to begin EHR submission as part of the 2009 PQRI. Rather, we believe that it is more prudent to allow the 2008 testing process to be completed.

Furthermore, we are aware of the importance of promoting and aligning with the work of health information technology (HIT) standards development organizations. By postponing implementation of EHR submissions for PQRI, we believe this alignment with and promotion of the adoption and uses of HIT standards will be enhanced.

Finally, we believe it would benefit eligible professionals to know in advance of the start of a PQRI reporting period which EHR vendors are qualified to submit clinical quality data extracted from their EHR to CMS. At this point, we would be unable to identify such vendors in view of the incomplete testing process.

Rather than implement EHR reporting for the 2009 PQRI, and in order to prepare for possible implementation of EHR reporting for the 2010

PQRI, we will complete the 2008 testing and continue additional testing in 2009. In addition, upon completion of satisfactory testing, we intend to qualify EHR vendors and their specific products to submit clinical quality data extracted from their EHR products to the CMS quality data warehouse. As vendors qualify, we would post the names on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/pqri for informational purposes.

It should be noted, however, that qualification of vendors for EHR data submission does not assure that we will include EHR data submission as an option for satisfactorily reporting data on quality measures for the 2010 PQRI. Rather, this will be the subject of future notice and comment rulemaking.

The process we will use to qualify EHR vendors and their specific products is described below.

Comment: One commenter suggested we allow non-CCHIT certified EHRs to submit data to PQRI.

Response: We are not planning to accept data via EHRs for purposes of satisfactorily reporting data on quality measures in the 2009 PQRI and instead will only continue testing in the 2009 PQRI. We do not intend to limit testing to CCHIT certified EHRs given the fact that relevant certification standards may not yet have been adopted. Any EHR quality data submission will be required to comply with all current regulations regarding security, privacy, and HIPAA.

Comment: A few commenters suggested allowing EHRs to report quality measures data on measures groups.

Response: We did not propose this option because of our concerns with the feasibility of such reporting. In addition, as discussed previously, we are not including EHR reporting for the 2009 PQRI as an option but instead will continue testing during 2009.

Comment: A commenter was concerned that CMS does not inadvertently facilitate anti-competitive behavior by allowing reporting of information on quality measures via EHRs.

Response: We are unclear as to how allowing quality data reporting through EHRs could result in anti-competitive behavior.

Comment: A few commenters suggested either paying more money so that providers can adopt HIT or paying more incentives for measures submitted electronically.

Response: We are authorized by statute to provide incentive payments in 2009 to eligible professionals who satisfactorily report

PQRI quality measures data and/or who are successful electronic prescribers only. We lack specific authority to pay eligible professionals more incentives for the adoption of HIT or for measures submitted electronically.

The basis for the calculation of the incentive payment for PQRI is also statutorily defined and previously discussed. We do not have the authority to modify the amount of payments to promote particular objectives, nor to base the incentive payments for PQRI on using an electronic means of submission. As identified in section II.O1.d.i. below, we note that one of the structural measures selected for inclusion in the 2009 PQRI is an HIT measure (Measure 124).

Thus, an eligible professional who reports this measure along with meeting the other criteria for satisfactorily reporting for the 2009

PQRI can earn an additional 2.0 percent of their estimated total allowed charges for covered professional services furnished during the 2009 PQRI reporting period for their adoption and use of HIT.

Additionally, as described in section II.O2. of this final rule with comment period, we are authorized to pay a 2.0 percent incentive payment for eligible professionals who are successful electronic prescribers in 2009. The 2.0 percent incentive payment for successful electronic prescribers is a separate incentive payment from the 2.0 percent incentive payment authorized for satisfactory reporting of quality information for the 2009 PQRI.

Comment: A few commenters requested that we publish the submission standards for EHRs as soon as possible to allow practitioners and vendors adequate time to modify their systems by January 1, 2009. In addition, several commenters requested that the final rule specify the procedures and requirements that EHR vendors must meet to minimize errors in the EHR reporting process during the reporting period as well as procedures to be followed to correct for errors that may

Page 69830

occur when the vendor submits data to CMS.

Response: As stated above, we are not planning to accept data via

EHRs for purposes of satisfactorily reporting data on quality measures in the 2009 PQRI. We intend, however, to continue testing in 2009 and to qualify EHR vendors and their specific products to submit clinical quality data extracted from their EHR products to the CMS quality data warehouse so that we may potentially begin to accept data via EHRs for purposes of satisfactorily reporting data on quality measures in future

PQRI reporting. Therefore, by December 31, 2008, we anticipate posting on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/pqri a list of requirements that EHR vendors must be able to meet in order to self-nominate to have their product ``qualified'' to be able to participate in the continued testing phase in 2009 and with anticipation that such vendors' systems may be able to submit quality measures data in the future to CMS for PQRI on behalf of the eligible professional(s) using the system(s).

Based on the comments received related to our proposal to begin accepting data from EHRs for the 2009 PQRI and our experience thus far with testing the EHR reporting mechanism, we are not finalizing our proposal to allow eligible professionals to submit clinical quality data extracted from EHRs for purposes of receiving an incentive payment for the 2009 PQRI. Instead, we will continue to test the submission of clinical quality data extracted from EHRs in 2009. The measures on which specifications are available for testing EHR data submission are identified in Table 15. The specifications for these measures can be found on the QualityNet Web site at http://www.qualitynet.org/dcs/

ContentServer?cid=1214232460333&pagename=QnetPublic%2FPage%2FQnetTier3&c

=Page.

By December 31, 2008, we also anticipate posting on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/pqri a list of requirements that EHR vendors must be able to meet in order to self- nominate to have their product ``qualified'' to potentially be able to submit quality measures data for the 2010 PQRI to CMS. Qualifying EHR vendors ahead of actual data submission will facilitate the live data submission process.

EHR vendors interested in engaging in the 2009 testing and qualification process should review the EHR requirements document that will be posted on the PQRI section of the CMS Web site at http:// www.cms.hhs.gov. If an EHR vendor wishes to be included in the testing and qualification process, the vendor should submit a letter of self- nomination to CMS by February 13, 2009 to: PQRI EHR Nomination, Centers for Medicare & Medicaid Services, Office of Clinical Standards and

Quality, Quality Measurement and Health Assessment Group, 7500 Security

Blvd, Mail Stop S3-02-01, Baltimore, MD 21244-1850.

The EHR vendors who self-nominate will be included in a

``qualifying'' process (similar to the process previously established for registries) to assess their capabilities. If they are found to meet the requirements, the EHR vendors will be included in the data submission testing. These processes will have firm timelines that vendors must meet. Failure to meet any of these deadlines will be a basis for not continuing to consider the EHR vendor for qualification to submit data to the CMS quality data warehouse. The number of self- nominated vendors will determine the timeframe needed to complete the testing and qualification process. However, it is expected that this process will conclude by mid-summer 2009. The measures and reporting mechanism for the 2010 PQRI will be the subject of future notice and comment rulemaking. As previously noted, the completion of the EHR vendor quality data submission qualification process does not ensure that EHR reporting will be an option for the 2010 PQRI. c. Statutory Requirements for Measures Included in the 2009 PQRI i. Overview and Summary

Section 1848(k)(2)(B)(ii) of the Act requires CMS to publish in the

Federal Register by no later than August 15, 2008, a proposed set of quality measures that the Secretary determines would be appropriate for eligible professionals to use to submit data in 2009. In addition, section 1848(k)(2)(B)(iii) of the Act requires CMS to publish in the

Federal Register by no later than November 15, 2008, the final set of quality measures that would be appropriate for eligible professionals to use to submit data in 2009.

As discussed in the CY 2009 PFS proposed rule (73 FR 38565), in examining the statutory requirements of section 1848(k)(2)(B)(i) of the

Act, as amended by the MMSEA, we believe that the requirement that measures be endorsed or adopted by a consensus organization applies to each measure that would be included in the measure set for submitting quality data and/or quality measures results and numerator and denominator data on the quality measures on covered professional services furnished during 2009. Likewise, the requirement for measures to have been developed using a consensus-based process (as identified by the Secretary) applies to each measure. By contrast, we do not interpret the provision requiring inclusion of measures submitted by a specialty to apply to each measure. Rather, we believe this requirement means that in endorsing or adopting measures, a consensus organization must include in its consideration process at least some measures submitted by one physician or organization representing a particular specialty.

We also believe that under sections 1848(k)(2)(B)(ii) through (iii) of the Act, the Secretary is given broad discretion to determine which quality measures meet the statutory requirements and are appropriate for inclusion in the final set of measures for 2009. We do not interpret section 1848(k)(2)(B) of the Act to require that all measures that meet the basic requirements of section 1848(k)(2)(B)(i) of the Act be included in the 2009 set of quality measures. The statutory requirements for consensus organizations and the use of a consensus- based process for developing quality measures as they relate to the requirements for the 2009 PQRI measures were discussed in the CY 2009

PFS proposed rule (73 FR 38565 through 38566). As discussed in the proposed rule, consistent with the principle that measures used for 2009 be endorsed or adopted by a consensus organization and developed through the use of a consensus-based process, but without limiting the 2009 PQRI measures to those meeting the definition of a voluntary consensus standard under the National Technology Transfer and

Advancement Act of 1995 (Pub. L. 104-113) (NTTAA), we interpret

``consensus-based process for developing measures'' as used in section 1848(k) of the Act to encompass not only the basic development work of the formal measure developer, but also to include the achievement of consensus among stakeholders in the health care system.

In addition, section 1848(k)(2)(D) of the Act, as added by the

MIPPA, requires that for each 2009 PQRI quality measure, ``the

Secretary shall ensure that eligible professionals have the opportunity to provide input during the development, endorsement, or selection of measures applicable to services they furnish.'' Eligible professionals have the opportunity to provide input during the development of a measure during the public comment phase of a measure's

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development. As part of the measure development process, measure developers typically solicit public comments on measures that they are testing in order to determine whether additional refinement of the measure(s) is needed prior to submission for consensus endorsement.

Additional information on the measure development process used by CMS contractors is available in the ``Quality Measures Development

Overview'' document found on the CMS Web site at http:// www.cms.hhs.gov/QualityInitiativesGenInfo/downloads/

QualityMeasuresDevelopmentOverview.pdf. Eligible professionals also have the opportunity to provide input on a measure as the measure is being vetted through the consensus endorsement and/or adoption process.

Both the NQF and AQA employ a public comment period for measures vetted through their respective consensus endorsement or adoption processes.

Finally, eligible professionals have an opportunity to provide input on measures selected for inclusion in PQRI through the notice and comment rulemaking process we use to announce the measures selected for inclusion in PQRI each year. As required by section 1848(k)(2)(B)(ii) of the Act, we proposed measures for the 2009 PQRI in the Federal

Register in July, which was followed by a 60-day comment period in which eligible professionals had the opportunity to comment.

Accordingly, we believe the additional requirement under MIPPA with regard to the 2009 PQRI has been met in multiple ways. ii. Summary of Comments and Responses

We received several comments related to the statutory requirements for measures included in the 2009 PQRI and/or our approach to the selection of measures, which are summarized and addressed below.

Comment: Several comments expressed concerns about the AQA's structure and original intended purpose not being ideally suited to its current role in PQRI, and its role in the measure endorsement process not clearly adding value to the process. Many comments noted that the

AQA does not meet the NTTAA definition of a ``voluntary consensus standards body.''

Response: Both the NQF and the AQA were identified as examples of consensus organizations under section 1848(k)(2)(B)(i) of the Act. We interpreted this to mean that for purposes of the PQRI, these organizations, as constituted on the date of enactment of the MIEA-

THRCA authorizing legislation, are considered to be consensus organizations. On the other hand we stated that we found the NQF to be an organization organized and operating in a manner that meets the

NTTAA definition of a ``voluntary consensus standards body,'' but we did not find that the AQA constituted such an organization. We also stated our policy preference for measures endorsed by an organization that meets the NTTAA definition of ``voluntary consensus standards body'' to one that does not so qualify. Further, we stated our policy that a measure that was specifically declined for endorsement by the

NQF would not be included in PQRI even though it was adopted by AQA.

Comment: Several commenters commended NQF for the scientific rigor of its structure and review processes. Some commenters in favor of establishing a single consensus organization entity whose approval would qualify a measure for PQRI inclusion went on to name NQF as the leading or only named candidate for such an organization.

Response: As stated previously, we have stated a policy preference for NQF-endorsed measures. However, we are not limited by statute to using only NQF-endorsed measures.

Comment: We received some comments supportive of having measures that originate from a variety of sources and opposed to requiring PQRI measurement development to come solely from physician controlled organizations. At the same time, several commenters suggested we consider establishing as policy that quality measures to be used by, and analyzed at the level of, individual PQRI-eligible professionals, must be developed by clinician controlled organizations to assure relevance and promote uptake by the eligible professional community.

Multiple commenters suggested that explicit preference be given for measures developed or endorsed by physician specialty societies, in the context of consensus-organization review and CMS measure selection processes. Some commenters stated that the AMA-PCPI should be the sole source for physician level measures. Several commenters specifically presented an interpretation of the requirement under section 1848(k)(2)(B)(i) of the Act for the 2009 PQRI measures to include measures submitted by a physician specialty as meaning that the 2009

PQRI should include only measures developed by physician organizations, to assure physician control of available measures applicable to assessing the clinical performance of individual physicians.

Response: Physician involvement and leadership is standard in the work of both measure developers and consensus organizations. As a result, physicians are actively involved at all levels of measure development and consensus adoption and endorsement. We are in agreement that physician expertise is an important ingredient in measure development and in the consensus process. We further recognize the leadership of physician organizations, as is reflected in the large number of physician quality measures included in PQRI which were developed by the AMA-PCPI and its participating specialty societies.

However, we do not agree that physicians should be in complete control of the process of measure development, as would be the case if measures were required to be developed solely by physician-controlled organizations. Any such restriction would unduly limit the basic development of physician quality measures and the scope and utility of measures that may be considered for endorsement as voluntary consensus standards. We do not interpret the provisions in section 1848(k)(2)(B)(i) of the Act to place special restrictions on the type or make up of the organizations carrying out this basic development of physician measures, such as restricting the initial development to physician-controlled organizations. Similarly, we do not interpret section 1848(k)(2)(B)(i) of the Act to require that each measure included in the 2009 PQRI have been developed by a physician specialty.

Section 1848(k)(2)(B)(i) of the Act, thereby, maintains flexibility in potential sources of measure consensus review, which is, like having multiple sources of measure development, key to maintaining a robust marketplace for development and review of quality measures.

Comment: Several comments addressed gaps in the PQRI measure set, such as the lack of measures related to patient-centeredness, equity/ disparities, and episodes of care based efficiency. One comment expressed concern that the PQRI measures appear to be targeted to single conditions and to patients where classical treatment goals are appropriate and do not contain any quality measures specifically addressing multiple, co-morbid conditions. A few comments urged CMS to adopt quality measures that would enable the full range of physicians to participate and to identify and add more quality measures to fill the gaps. The commenters also requested that we consider developing interim opportunities for eligible professionals for whom there is a

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shortage of available measures to participate in the PQRI and to receive an incentive for doing so. One comment urged funding for consumer-relevant measure development to fill the existing gaps and to include language in the measure development contracts that reflects the perspectives of consumers and purchasers. Another commenter urged us to include more measures on which specifications for electronic data submission via EHRs are available.

Response: Health care quality measures are currently developed by a variety of organizations and used by a variety of governmental and nongovernmental, and public-private initiatives which have various and at times differing priorities and programmatic needs for quality measures. As reflected by the considerations for identifying proposed

PQRI quality measures described in the CY 2009 PFS proposed rule (73 FR 38566), we are committed to having a broad and robust set of quality measures for the PQRI. However, we largely depend on the development of measures by professional organizations and other measure developers.

Although we had significant involvement in the development of measures applicable to eligible professionals at the start of the PQRI, ideally we would not need to be closely involved in the development of clinician-level quality measures but would select from measures that meet the statutory requirements. Thus, we encourage professional organizations and other measure developers to fund and develop measures that address some of the gaps identified by the commenters.

Comment: One comment suggested that we add additional measures in

July of each year for implementation in that year's PQRI. For example, in July 2009, we should announce additional measures for inclusion in the 2009 PQRI.

Response: Section 1848(k)(2)(B)(ii) requires us to publish a proposed set of quality measures for inclusion in a particular year's

PQRI program in the Federal Register by no later than August 15th of the prior year. Additionally, section 1848(k)(2)(B)(iii) requires us to publish a final set of quality measures for inclusion in a particular year's PQRI program in the Federal Register by no later than November 15th of the prior year. We are not authorized to make any changes to the final set of PQRI quality measures for a particular year once the set has been published in the Federal Register.

However, as explained in the CY 2009 PFS proposed rule (73 FR 38570) we introduced a test measures process during 2008, which gives eligible professionals the opportunity to submit the quality data codes for measures included in the 2008 Measure Testing Process. No financial incentive is associated with the reporting of these 2008 test measures though. Instead, the test measures process helps provide experience with using the measures which can contribute to future consideration for the PQRI. We proposed and are finalizing as 2009 PQRI measures certain measures included in the 2008 Test Measures Process. d. The Final 2009 PQRI Quality Measures

In the CY 2009 PFS proposed rule (73 FR 38566 through 38567), we solicited comments on the implication of including or excluding 175 specific quality measures in 4 categories. We also explained that while we recognized that some commenters may wish to recommend additional measures for inclusion in the 2009 PQRI measures that we had not proposed, we would not be able to consider such additional measures for inclusion in the 2009 measure set. We also described several considerations used for selecting the measures proposed for the 2009

PQRI.

We received multiple comments on the proposed 2009 PQRI quality measures, which are addressed below.

Comment: A number of comments requested or recommended that we make readily available on an ongoing basis more detailed information on the measure development process and measures in development. Numerous commenters also requested final measure specifications be published as far in advance of the beginning of the reporting period as possible, and that more detailed information about measures proposed or finalized for use in PQRI be published at the same time as or in advance of future rulemaking.

Response: We agree that it is desirable for the public to have information on the measures development process and measures in development. To this end CMS has developed a standardized process to be used for CMS contracted measures development. This standardized process is detailed in the ``Quality Measures Development Overview'' document found on the CMS Web site at http://www.cms.hhs.gov/

QualityInitiativesGenInfo/downloads/

QualityMeasuresDevelopmentOverview.pdf. Under the standardized measures development process, we plan that all CMS contracted measures developers, in the future, will post the measures for public comment on the CMS Web site rather than solely on the individual contractor's Web site. This will allow a uniform access point for information during the

CMS contracted basic development process for measures intended for

PQRI. Additionally, other major measures developers publish measures and specifications during development and seek public comment as do both NQF and AQA during their consensus processes.

We agree with the commenters that it is desirable to provide final measure specifications sufficiently in advance of the reporting period to allow reasonable time for professionals to analyze new or revised measures and implement any needed changes in their office workflows to accurately capture and successfully submit data on a selection of measures applicable to their practice on which they can act to improve the quality of the services they furnish. Having detailed information on measures available in advance of the reporting period also enhances the ability of vendors (such as practice-management software, billing services, and electronic health records vendors) to support professionals' successful implementation of revised data-capture processes for the measures.

Given that section 1848(k)(2)(B)(iii) requires that we publish the final list of 2009 PQRI measures in the Federal Register no later than

November 15, 2008, we expect to publish detailed specifications shortly after that date. Detailed measure specifications for measures new or revised for 2009 PQRI will be posted on the Measures/Codes tab of the

PQRI section of the CMS Web site at http://www.cms.hhs.gov/pqri. These detailed specifications will include instructions for reporting and identifying the circumstances in which each measure is applicable. The detailed technical specifications for measures in the final listing for the 2009 PQRI remain potentially subject to corrections until the start of the 2009 reporting period, as we stated in the proposed rule. In addition, the 2009 PQRI quality measure specifications for any given quality measure may be different from specifications for the same quality measure used for 2008. Specifications for all 2009 PQRI quality measures, whether or not included in the 2008 PQRI program, must be obtained from the specifications document for 2009 PQRI quality measures.

Since its inception, the PQRI program has expanded rapidly in terms of the number of measures included in the PQRI. This rapid growth was necessary in order to meet a primary objective of having a sufficient number of measures to allow broad participation by eligible professionals who cover a broad scope

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of services provided to Medicare beneficiaries. We now have a broad range of measures and expect to rely more on the test measures program to introduce new measures. In this way, by the time they may be proposed for inclusion in a set of measures for a particular year, the measures specifications will be published, established, and utilized by eligible professionals for test submission.

Comment: Numerous commenters suggested quality measures in addition to the quality measures we had proposed in Tables 11 through 14 of the

CY 2009 PFS proposed rule (73 FR 38567 through 38572) for the 2009

PQRI.

Response: We have not included in final 2009 PQRI quality measures any quality measures that were not identified in the CY 2009 PFS proposed rule as proposed 2009 PQRI measures. As discussed above in this rule, we are obligated by section 1848(k)(2)(B)(ii) of the Act to publish and provide opportunity for public comment on proposed 2009

PQRI quality measures. Measures recommended for selection via comments on the proposed rule that were not included in the proposed rule have not been placed before the public as part of notice and comment rulemaking process. Thus, such additional measures recommended via comments on the proposed rule cannot be included in the 2009 PQRI quality measure set that is required to be finalized via publication in the Federal Register by November 15, 2008 in accordance with section 1848(k)(2)(B)(iii) of the Act.

However, we have captured these recommendations and will have them available for consideration in identifying measure sets for future years' PQRI and other initiatives to which those measures may be pertinent or possibly to be introduced as part of a PQRI Test Measures

Process.

Comment: We received a few comments that suggested that some measures are not conducive to claims-based reporting but are good measures if submitted via a registry or an EHR.

Response: We are not finalizing the proposal to allow submission of clinical quality data extracted from EHRS for the 2009 PQRI. We, however, agree that some measures are not conducive to claims-based reporting. For the 2009 PQRI, there are 18 measures that will only be accepted for reporting via registries due to their complex measure specifications, which require multiple diagnosis codes; a low number of satisfactory submissions during the 2007 PQRI; and a high occurrence of inaccurate quality date codes reporting for the 2007 PQRI. These measures are identified in Tables 15, 16, 18, and 22 with a ``+'' after the Measure Title.

For the 2009 PQRI, the following 5 quality measures in Table 15 will be reportable only through registries as individual quality measures:

Measure 7 CAD: Beta-Blocker Therapy for CAD

Patients with Prior Myocardial Infarction (MI)

Measure 33 Stroke and Stroke Rehabilitation:

Anticoagulant Therapy Prescribed for Atrial Fibrillation at Discharge

Measure 46 Medication Reconciliation:

Reconciliation After Discharge from an Inpatient Facility

Measure 81 End-Stage Renal Disease (ESRD): Plan of Care for Inadequate Hemodialysis in ESRD Patients

Measure 82 ESRD: Plan of Care for Inadequate

Peritoneal Dialysis

The following 8 quality measures in Tables 16 and 22 will be reportable only through registries as individual quality measures or part of the CABG measures group for the 2009 PQRI:

CABG: Prolonged Intubation (Ventilation)

CABG: Deep Sternal Wound Infection Rate

CABG: Stroke/Cerebrovascular Accident (CVA)

CABG: Post-operative Renal Insufficiency

CABG: Surgical Re-exploration

CABG: Anti-platelet Medications at Discharge

CABG: Beta Blockade at Discharge

CABG: Lipid Management and Counseling

Finally, the following 5 quality measures in Table 18 will be reportable only through registries as individual quality measures for the 2009 PQRI:

Pediatric ESRD: Adequacy of Hemodialysis

HIV/AIDS: CD4+ Cell Count or CD4+ Percentage

HIV/AIDS: Pneumocystis Jiroveci Pneumonia (PCP)

Prophylaxis

HIV/AIDS: Adolescent and Adult Patients with HIV/AIDS Who

Are Prescribed Potent Antiretroviral Therapy

HIV/AIDS: HIV RNA Control After 6 Months of Potent

Antiretroviral Therapy

Comment: One commenter suggested that CMS accept as many measures as possible that are based solely on information derived from administrative claims so that professionals would not have to do additional coding.

Response: Under the PQRI program eligible professionals are provided an incentive payment for submission of quality data. What is suggested would not involve submission of quality data but merely normal claims submission from which quality inferences would be made.

An important difference in that approach to PQRI is that under PQRI, by submitting quality data, the eligible professional indicates that the patient is appropriately attributed to that professional. When purely administrative data are used, attribution rules would need to be applied, with which the physician or other eligible professional may not agree. Thus, focusing on administrative-data based measures only could have the unintended consequence of holding the eligible professional responsible for certain services which the eligible professional might feel are beyond their scope of care for a particular patient.

Comment: Several commenters recommended changes to specific quality measures' titles, definitions, and detailed specifications or coding.

Many of these recommendations were based on alternative interpretations of clinical evidence or concerns about the utility of the measures.

Some requests were specifically concerned that measures be expanded to include specific professionals to whom the measure may be applicable such as occupational therapists, registered dieticians, and audiologists. Specifically, one commenter suggested that in order to maximize the impact of Measure 1 Diabetes Mellitus: Hemoglobin

A1c Poor Control in Diabetes Mellitus, the PQRI specifications should continue to require a performance period of 12 months and reporting that identifies whether A1c control is good (that is, A1c 7.0 percent), or poor (that is, A1c > 9.0 percent). Another commenter requested that CMS re-evaluate the use of inpatient site of service codes (99241 through 99245) for Measure 5 Heart Failure: Angiotensin-Converting

Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy for Left Ventricular Systolic Dysfunction (LVSD), Measure 6

CAD: Oral Antiplatelet Therapy Prescribed for Patients with CAD,

Measure 7 CAD: Beta-Blocker Therapy for CAD Patients with

Prior MI, and Measure 8 Heart Failure: Beta-Blocker Therapy for LVSD. Also another commenter requested the addition of specifications for inpatient reporting for Measure 56

Community-Acquired Pneumonia (CAP): Vital Signs, Measure 57

CAP: Assessment of Oxygen Saturation, Measure 58 CAP:

Assessment of Mental Status, and Measure 59 CAP: Empiric

Antibiotic. One commenter expressed gratitude that audiologists are now eligible to

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participate in PQRI and willingness to work with the measure developer to expand Measure 94 Otitis Media with Effusion (OME):

Diagnostic Evaluation--Assessment of Tympanic Membrane Mobility and

Measure 95 Otitis Media with Effusion (OME): Hearing Testing.

Lastly, one commenter requested that we not use Measures 73

Cancer: Plan for Chemotherapy Documented and Measure T143 Cancer Care:

Medical and Radiation--Plan of Care for Pain until the measure developers revise the measure specifications to include all chemotherapy and biologic disease modalities recognized in clinical guidelines. Also, this same commenter requested that we not use the

Rheumatoid Arthritis measures group until the measures' developer revises the measures to include all biologic disease-modifying antirheumatic drugs (DMARDS) used as a monotherapy or in combination with nonbiologic DMARDS, such as methotrexate.

Response: Quality measures that have completed the consensus processes of NQF or AQA have a designated party (generally the measure developer/owner) who has accepted responsibility for maintaining the measure. In general, it is the role of the measure owner, developer, or maintainer to make changes to a measure. The measure maintainer and/or the developer/owner of a measure included in the final set of quality measures selected for the 2009 PQRI is identified as the ``Measure

Source'' in Tables 15 through 18. In addition, NQF has, for its endorsed measures, an established maintenance process which may be accessed.

The Secretary is required to select measures through notice and comment rulemaking. We do not, however, use notice and comment rulemaking as a means to update or modify measure specifications. We retain the ability to update or modify specifications to the measures until December 31, 2008. After that date, there will be no changes to the measure for the 2009 reporting period(s).

Comment: A number of comments requested or recommended that CMS include ``paired'' measures in the 2009 PQRI. Commenters noted that while under review by the NQF Steering Committee several measures proposed for 2009 were recommended to be implemented as ``paired measures'' by the NQF. Commenters referenced the following proposed measures as paired measures based on the NQF Steering Committee's recommendations:

(1) Hepatitis C: Hepatitis A Vaccination and Hepatitis C: Hepatitis

B Vaccination.

(2) Hepatitis C: Ribonucleic Acid (RNA) Testing Before Initiating

Treatment and Hepatitis C: HCV Genotype Testing Prior to Therapy.

(3) Oncology: Medical and Radiation--Pain Intensity Quantified and

Oncology: Medical and Radiation--Plan of Care for Pain.

Response: The 2009 PQRI will include four measures sets that can be considered paired measures. Each paired measures set consists of two closely related individual measures, but which are composed of two similar and complementary aspects of care. The measures assess uniquely different constructs in the assessment and/or management of a particular condition. Thus, while we note the recommendation that the measures in a particular paired measures set be reported together, we do not require for the 2009 PQRI that the measures in a particular paired measures set be reported together.

These paired measures do not constitute a measures group. These measures may be subject to the measures validation strategy posted on

PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI/25_

AnalysisAndPayment.asp#TopOfPage. Under the measures validation strategy for eligible professionals that satisfactorily report less than three measures, failure to report the additional measure(s) in a valid set would cause the eligible professional to fail to meet the validation requirements.

The four paired measures sets for the 2009 PQRI are as follows:

(1) Hepatitis C: Hepatitis A Vaccination and Hepatitis C: Hepatitis

B Vaccination.

(2) Hepatitis C: Ribonucleic Acid (RNA) Testing Before Initiating

Treatment and Hepatitis C: HCV Genotype Testing Prior to Therapy.

(3) Oncology: Medical and Radiation--Pain Intensity Quantified and

Oncology: Medical and Radiation--Plan of Care for Pain.

(4) Falls: Risk Assessment and Falls: Plan of Care.

Reporting instructions and detailed measure specifications for the 2009 PQRI quality measures will be available by no later than December 31, 2008 on the PQRI section of the CMS Web site at http:// www.cms.hhs.gov/pqri.

Based on our review of these comments, the final set of 153 quality measures selected for the 2009 PQRI are listed in Tables 15 through 18.

These measures can be categorized as follows: (1) Measures selected from the 2008 PQRI quality measures set; (2) additional NQF-endorsed measures; (3) additional AQA-adopted measures; and (4) additional measures that had not received NQF endorsement or AQA adoption at the time the proposed rule was published but whose selection was contingent upon whether they received NQF endorsement or AQA adoption by August 31, 2008.

No changes (that is, additions or deletions of measures) will be made after publication of this final rule with comment period. However, as was the case for 2008, we may make modifications or refinements, such as revisions to measures titles and code additions, corrections, or revisions to the detailed specifications for the 2009 measures until the beginning of the reporting period. Such specification modifications may be made through the last day preceding the beginning of the reporting period. The 2009 measures specifications will be available on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/pqri when they are sufficiently developed or finalized. We are targeting finalization and publication of the detailed specifications for all 2009 PQRI measures on the PQRI section of the CMS Web site by November 15, 2008 and will in no event publish these specifications later than

December 31, 2008. The detailed specifications will include instructions for reporting and identify the circumstances in which each measure is applicable.

As described in section II.O1.b.ii. above, we are establishing a total of seven measures groups for use in the 2009 PQRI. The measures selected for inclusion in each of the 2009 measures groups are listed in Tables 19 through 25. i. Measures Selected From the 2008 PQRI Quality Measures Set

In the CY 2009 PFS proposed rule (73 FR 38567 through 38570) we proposed to include in the 2009 PQRI quality measures set 111 2008 PQRI quality measures. We received several comments on the 111 proposed measures selected from the 2008 PQRI quality measure set. The comments and our responses to those comments are discussed below.

Comment: We received numerous comments in support of the 2008 PQRI measures selected for the 2009 PQRI. One commenter supports the retention of all the 2008 PQRI measures proposed for 2009. Other commenters specifically support inclusion of the following proposed 2008 PQRI measures in the 2009 PQRI:

Measure 1 Diabetes Mellitus: Hemoglobin A1c Poor

Control in Diabetes Mellitus

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Measure 6 Coronary Artery Disease (CAD): Oral

Antiplatelet Therapy Prescribed for Patients With CAD

Measure 11 Stroke and Stroke Rehabilitation:

Carotid Imaging Reports

Measure 24 Osteoporosis: Communication With the

Physician Managing Ongoing Care Post-Fracture

Measure 39 Screening or Therapy for Osteoporosis for Women Aged 65 Years and Older

Measure 40 Osteoporosis: Management Following

Fracture

Measure 41 Osteoporosis: Pharmacologic Therapy

Measure 48 Urinary Incontinence: Assessment of

Presence or Absence of Urinary Incontinence in Women Aged 65 Years and

Older

Measure 58 Community-Acquired Pneumonia (CAP):

Assessment of Mental Status

Measure 84 Hepatitis C: Ribonucleic Acid (RNA)

Testing Before Initiating Treatment

Measure 85 Hepatitis C: HCV Genotype Testing

Prior to Therapy

Measure 86 Hepatitis C: Consideration for

Antiviral Therapy in HCV Patients

Measure 94 Otitis Media With Effusion (OME):

Diagnostic Evaluation--Assessment of Tympanic Membrane Mobility

Measure 95 Otitis Media With Effusion (OME):

Hearing Testing

Measure 110 Preventive Care and Screening:

Influenza Immunization for Patients >= 50 Years Old

Measure 111 Preventive Care and Screening:

Pneumonia Vaccination for Patients 65 years and Older

Measure 112 Preventive Care and Screening:

Screening Mammography

Measure 113 Preventive Care and Screening:

Colorectal Cancer Screening

Measure 114 Preventive Care and Screening:

Inquiry Regarding Tobacco Use

Measure 115 Preventive Care and Screening:

Advising Smokers to Quit

Measure 128 Preventive Care and Screening: Body

Mass Index (BMI) Screening and Follow-Up

We also received several comments specifically suggesting that

Measure 73 Cancer: Plan for Chemotherapy Documented be removed from the 2009 PQRI quality measures for failure to achieve NQF endorsement.

Response: Table 15 shows that 101 of 111 proposed 2008 PQRI quality measures have been finalized for the 2009 PQRI. All of the measures specifically supported by commenters are included in Table 15. As suggested by commenters Measure 73 Cancer: Plan for

Chemotherapy Documented has been removed from the 2009 PQRI quality measures set because the measure was considered and specifically declined for endorsement by NQF on or before August 31, 2008.

Comment: With respect to the two proposed structural measures

(Measure 124 and Measure 125), we received 2 comments suggesting that we allow a practice or an eligible professional to simply attest to the use of an EHR or electronic prescribing in their office rather than report it on a claim as this was considered burdensome. Another comment recommended we treat an eligible professional's recognition under the National Committee for Quality

Assurance (NCQA) Physician Practice Connection (PPC) as equivalent to reporting the two structural measures (Measures 124 and 125).

Response: For those professionals using an EHR, their system should be able to auto populate a superbill with the appropriate G code for this measure. Many EHRs already code the visit with diagnosis and level of service. The G code could be added to the superbill in this way. The

EHR measure (Measure 124) requires more than just having an

EHR system and software available in the office; rather the measure also measures ongoing use of the systems.

As required by section 1848(m)(3)(A) of the Act, as redesignated and amended by the MIPPA, we are removing the electronic prescribing measure (measure 125) from the 2009 PQRI quality measure set and adopting the measure for use in the e-prescribing incentive program described in section II.O2. of this final rule with comment period.

With respect to the recommendation to consider recognition under the NCQA PPC as equivalent to satisfactory PQRI reporting, a fundamental PQRI requirement is that the data be reported on PQRI measures. The PPC is a proprietary recognition program that does not utilize PQRI Measures 124 or 125.

Comment: One commenter requested clarification of a statement made in the proposed rule regarding the 2008 PQRI Measure 4

Screening for Future Fall Risk not proposed for 2009. This commenter noted that the measure developer did not make a request to retire this measure from PQRI nor was the measure replaced by a new AQA-adopted or

NQF-endorsed measure proposed for 2009 as stated in the CY 2009 PFS proposed rule (73 FR 38567). The commenter advocated for Measure 4 Screening for Future Fall Risk to remain available for the 2009 PQRI. Another commenter supported the removal of Measure 4 Screening for Future Fall Risk as a result of two new substantially similar fall measures proposed for 2009.

Response: The commenter was correct in noting that the proposed rule incorrectly stated that the 2008 PQRI Measure 4 Screening for Future Fall Risk not proposed for 2009 was retired and intended to be replaced by new AQA-adopted or NQF-endorsed measures proposed for 2009.

However, we are not including Measure 4 Screening for

Future Fall Risk in the final set of 2009 PQRI quality measures. We consider the following proposed AQA-adopted measures included in the final 2009 PQRI quality measures set listed in Table 17 to substantially cover the same care process as Measure 4

Screening for Future Fall Risk and more comprehensive: Falls: Risk

Assessment and Falls: Plan of Care.

In addition, as previously stated in this final rule with comment period, we are obligated by section 1848(k)(2)(B)(ii) of the Act to publish and provide opportunity for public comment on proposed 2009

PQRI quality measures prior to including them in the final 2009 PQRI quality measures set.

Based on whether a measure retained its NQF endorsement status as of August 31, 2008 and the comments received, we are finalizing in the 2009 PQRI quality measure set the following 101 of 111 proposed 2008

PQRI measures identified in Table 15.

Table 15--Final 2008 PQRI Measures Selected for 2009

Measure number and title

Measure source

1. Diabetes Mellitus: Hemoglobin A1c Poor

NCQA.

Control in Diabetes Mellitus*. 2. Diabetes Mellitus: Low Density

NCQA.

Lipoprotein (LDL-C) Control in Diabetes

Mellitus*. 3. Diabetes Mellitus: High Blood Pressure

NCQA.

Control in Diabetes Mellitus*. 5. Heart Failure: Angiotensin-Converting

American Medical

Enzyme (ACE) Inhibitor or Angiotensin

Association--Physician

Receptor Blocker (ARB) Therapy for Left

Consortium for Performance

Ventricular Systolic Dysfunction (LVSD)*.

Improvement (AMA-PCPI).

Page 69836

6. Coronary Artery Disease (CAD): Oral

AMA-PCPI.

Antiplatelet Therapy Prescribed for

Patients with CAD. 7. Coronary Artery Disease (CAD): Beta-

AMA-PCPI.

Blocker Therapy for CAD Patients with

Prior Myocardial Infarction (MI)\+\,*. 8. Heart Failure: Beta-Blocker Therapy for AMA-PCPI.

Left Ventricular Systolic Dysfunction

(LVSD). 9. Major Depressive Disorder (MDD):

NCQA.

Antidepressant Medication During Acute

Phase for Patients with MDD. 10. Stroke and Stroke Rehabilitation:

AMA-PCPI/NCQA.

Computed Tomography (CT) or Magnetic

Resonance Imaging (MRI) Reports. 11. Stroke and Stroke Rehabilitation:

AMA-PCPI/NCQA.

Carotid Imaging Reports. 12. Primary Open Angle Glaucoma (POAG):

AMA-PCPI/NCQA.

Optic Nerve Evaluation. 14. Age-Related Macular Degeneration (AMD): AMA-PCPI/NCQA.

Dilated Macular Examination. 18. Diabetic Retinopathy: Documentation of AMA-PCPI/NCQA.

Presence or Absence of Macular Edema and

Level of Severity of Retinopathy. 19. Diabetic Retinopathy: Communication

AMA-PCPI/NCQA. with the Physician Managing Ongoing

Diabetes Care. 20. Perioperative Care: Timing of

AMA-PCPI/NCQA.

Antibiotic Prophylaxis--Ordering Physician. 21. Perioperative Care: Selection of

AMA-PCPI/NCQA.

Prophylactic Antibiotic--First OR Second

Generation Cephalosporin. 22. Perioperative Care: Discontinuation of AMA-PCPI/NCQA.

Prophylactic Antibiotics (Non-Cardiac

Procedures). 23. Perioperative Care: Venous

AMA-PCPI/NCQA.

Thromboembolism (VTE) Prophylaxis (When

Indicated in ALL Patients). 24. Osteoporosis: Communication With the

AMA-PCPI/NCQA.

Physician Managing Ongoing Care Post-

Fracture. 28. Aspirin at Arrival for Acute Myocardial AMA-PCPI/NCQA.

Infarction (AMI). 30. Perioperative Care: Timing of

AMA-PCPI/NCQA.

Prophylactic Antibiotics--Administering

Physician. 31. Stroke and Stroke Rehabilitation: Deep AMA-PCPI/NCQA.

Vein Thrombosis Prophylaxis (DVT) for

Ischemic Stroke or Intracranial Hemorrhage. 32. Stroke and Stroke Rehabilitation:

AMA-PCPI/NCQA.

Discharged on Antiplatelet Therapy. 33. Stroke and Stroke Rehabilitation:

AMA-PCPI/NCQA.

Anticoagulant Therapy Prescribed for

Atrial Fibrillation at Discharge\+\. 34. Stroke and Stroke Rehabilitation:

AMA-PCPI/NCQA.

Tissue Plasminogen Activator (t-PA)

Considered. 35. Stroke and Stroke Rehabilitation:

AMA-PCPI/NCQA.

Screening for Dysphagia. 36. Stroke and Stroke Rehabilitation:

AMA-PCPI/NCQA.

Consideration of Rehabilitation Services. 39. Screening or Therapy for Osteoporosis

AMA-PCPI/NCQA. for Women Aged 65 Years and Older. 40. Osteoporosis: Management Following

AMA-PCPI/NCQA.

Fracture. 41. Osteoporosis: Pharmacologic Therapy.... AMA-PCPI/NCQA. 43. Coronary Artery Bypass Graft (CABG):

The Society of Thoracic

Use of Internal Mammary Artery (IMA) in

Surgeons (STS).

Isolated CABG Surgery. 44. Coronary Artery Bypass Graft (CABG):

STS.

Preoperative Beta-Blocker in Patients with

Isolated CABG Surgery. 45. Perioperative Care: Discontinuation of AMA-PCPI/NCQA.

Prophylactic Antibiotics (Cardiac

Procedures). 46. Medication Reconciliation:

AMA-PCPI/NCQA.

Reconciliation After Discharge from an

Inpatient Facility\+\. 47. Advance Care Plan...................... AMA-PCPI/NCQA. 48. Urinary Incontinence: Assessment of

AMA-PCPI/NCQA.

Presence or Absence of Urinary

Incontinence in Women Aged 65 Years and

Older. 49. Urinary Incontinence: Characterization AMA-PCPI/NCQA. of Urinary Incontinence in Women Aged 65

Years and Older. 50. Urinary Incontinence: Plan of Care for AMA-PCPI/NCQA.

Urinary Incontinence in Women Aged 65

Years and Older. 51. Chronic Obstructive Pulmonary Disease

AMA-PCPI.

(COPD): Spirometry Evaluation. 52. Chronic Obstructive Pulmonary Disease

AMA-PCPI.

(COPD): Bronchodilator Therapy. 53. Asthma: Pharmacologic Therapy.......... AMA-PCPI. 54. 12-Lead Electrocardiogram (ECG)

AMA-PCPI/NCQA.

Performed for Non-Traumatic Chest Pain. 55. 12-Lead Electrocardiogram (ECG)

AMA-PCPI/NCQA.

Performed for Syncope. 56. Community-Acquired Pneumonia (CAP):

AMA-PCPI/NCQA.

Vital Signs. 57. Community-Acquired Pneumonia (CAP):

AMA-PCPI/NCQA.

Assessment of Oxygen Saturation. 58. Community-Acquired Pneumonia (CAP):

AMA-PCPI/NCQA.

Assessment of Mental Status. 59. Community-Acquired Pneumonia (CAP):

AMA-PCPI/NCQA.

Empiric Antibiotic. 64. Asthma: Asthma Assessment.............. AMA-PCPI. 65. Treatment for Children with Upper

NCQA.

Respiratory Infection (URI)--Avoidance of

Inappropriate Use. 66. Appropriate Testing for Children with

NCQA.

Pharyngitis. 67. Myelodysplastic Syndrome (MDS) and

AMA-PCPI/American Society

Acute Leukemias: Baseline Cytogenetic

of Hematology (ASH).

Testing Performed on Bone Marrow. 68. Myelodysplastic Syndrome (MDS):

AMA-PCPI/ASH.

Documentation of Iron Stores in Patients

Receiving Erythropoietin Therapy. 69. Multiple Myeloma: Treatment With

AMA-PCPI/ASH.

Bisphosphonates. 70. Chronic Lymphocytic Leukemia (CLL):

AMA-PCPI/ASH.

Baseline Flow Cytometry. 71. Breast Cancer: Hormonal Therapy for

AMA-PCPI/American Society

Stage IC-III Estrogen Receptor/

of Clinical Oncology

Progesterone Receptor (ER/PR) Positive

(ASCO)/National

Breast Cancer.

Comprehensive Cancer

Network (NCCN). 72. Colon Cancer: Chemotherapy for Stage

AMA-PCPI/ASCO/NCCN.

III Colon Cancer Patients. 76. Prevention of Catheter-Related

AMA-PCPI.

Bloodstream Infections (CRBSI)--Central

Venous Catheter Insertion Protocol.

Page 69837

79. End-Stage Renal Disease (ESRD):

AMA-PCPI.

Influenza Vaccination in Patients with

ESRD. 81. End-Stage Renal Disease (ESRD): Plan of AMA-PCPI.

Care for Inadequate Hemodialysis in ESRD

Patients\+\. 82. End-Stage Renal Disease (ESRD): Plan of AMA-PCPI.

Care for Inadequate Peritoneal Dialysis+. 83. Hepatitis C: Testing for Chronic

AMA-PCPI.

Hepatitis C--Confirmation of Hepatitis C

Viremia. 84. Hepatitis C: Ribonucleic Acid (RNA)

AMA-PCPI.

Testing Before Initiating Treatment. 85. Hepatitis C: HCV Genotype Testing Prior AMA-PCPI. to Therapy. 86. Hepatitis C: Consideration for

AMA-PCPI.

Antiviral Therapy in HCV Patients. 87. Hepatitis C: HCV Ribonucleic Acid (RNA) AMA-PCPI.

Testing at Week 12 of Treatment. 89. Hepatitis C: Counseling Regarding Risk AMA-PCPI. of Alcohol Consumption. 90. Hepatitis C: Counseling of Patients

AMA-PCPI.

Regarding Use of Contraception Prior to

Starting Antiviral Therapy. 91. Acute Otitis Externa (AOE): Topical

AMA-PCPI.

Therapy. 92. Acute Otitis Externa (AOE): Pain

AMA-PCPI.

Assessment. 93. Acute Otitis Externa (AOE): Systemic

AMA-PCPI.

Antimicrobial Therapy--Avoidance of

Inappropriate Use. 94. Otitis Media with Effusion (OME):

AMA-PCPI.

Diagnostic Evaluation--Assessment of

Tympanic Membrane Mobility. 95. Otitis Media with Effusion (OME):

AMA-PCPI.

Hearing Testing. 99. Breast Cancer Resection Pathology

AMA-PCPI/College of

Reporting: pT Category (Primary Tumor) and American Pathologists pN Category (Regional Lymph Nodes) with

(CAP).

Histologic Grade. 100. Colorectal Cancer Resection Pathology AMA-PCPI/CAP.

Reporting: pT Category (Primary Tumor) and pN Category (Regional Lymph Nodes) with

Histologic Grade. 102. Prostate Cancer: Avoidance of Overuse AMA-PCPI. of Bone Scan for Staging Low-Risk Prostate

Cancer Patients. 104. Prostate Cancer: Adjuvant Hormonal

AMA-PCPI.

Therapy for High-Risk Prostate Cancer

Patients. 105. Prostate Cancer: Three-Dimensional

AMA-PCPI.

(3D) Radiotherapy. 106. Major Depressive Disorder (MDD):

AMA-PCPI.

Diagnostic Evaluation. 107. Major Depressive Disorder (MDD):

AMA-PCPI.

Suicide Risk Assessment. 108. Rheumatoid Arthritis: Disease

NCQA.

Modifying Anti-Rheumatic Drug Therapy. 109. Osteoarthritis (OA): Function and Pain AMA-PCPI.

Assessment. 110. Preventive Care and Screening:

AMA-PCPI.

Influenza Immunization for Patients >= 50

Years Old*. 111. Preventive Care and Screening:

NCQA.

Pneumonia Vaccination for Patients 65 years and Older*. 112. Preventive Care and Screening:

NCQA.

Screening Mammography*. 113. Preventive Care and Screening:

NCQA.

Colorectal Cancer Screening*. 114. Preventive Care and Screening: Inquiry AMA-PCPI.

Regarding Tobacco Use. 115. Preventive Care and Screening:

NCQA.

Advising Smokers to Quit. 116. Inappropriate Antibiotic Treatment for NCQA.

Adults with Acute Bronchitis--Avoidance of

Inappropriate Use. 117. Diabetes Mellitus: Dilated Eye Exam in NCQA.

Diabetic Patient. 118. Coronary Artery Disease (CAD):

AMA-PCPI.

Angiotensin-Converting Enzyme (ACE)

Inhibitor or Angiotensin Receptor Blocker

(ARB) Therapy for Patients with CAD and

Diabetes and/or Left Ventricular Systolic

Dysfunction (LSVD). 119. Diabetes Mellitus: Urine Screening for NCQA.

Microalbumin or Medical Attention for

Nephropathy in Diabetic Patients. 121. Chronic Kidney Disease (CKD):

AMA-PCPI

Laboratory Testing (Calcium, Phosphorus,

Intact Parathyroid Hormone (iPTH) and

Lipid Profile). 122. Chronic Kidney Disease (CKD): Blood

AMA-PCPI.

Pressure Management. 123. Chronic Kidney Disease (CKD): Plan of AMA-PCPI.

Care: Elevated Hemoglobin for Patients

Receiving Erythropoiesis--Stimulating

Agents (ESA). 124. HIT: Adoption/Use of Electronic Health Quality Insights of

Records (EHR)*.

Pennsylvania (QIP)/CMS. 126. Diabetes Mellitus: Diabetic Foot and

American Podiatric Medical

Ankle Care, Peripheral Neuropathy:

Association (APMA).

Neurological Evaluation. 127. Diabetes Mellitus: Diabetic Foot and

APMA.

Ankle Care, Ulcer Prevention: Evaluation of Footwear. 128. Preventive Care and Screening: Body

QIP/CMS.

Mass Index (BMI) Screening and Follow-Up. 130. Documentation and Verification of

QIP/CMS.

Current Medications in the Medical Record. 131. Pain Assessment Prior to Initiation of QIP/CMS.

Patient Treatment. 134. Screening for Clinical Depression..... QIP/CMS.

\+\ This measure is reportable only via registry-based reporting and is not reportable via claims-based reporting.

\*\ This measure is 1 of 10 measures on which specifications are available for testing electronic submission via EHRs.

The following proposed measures included in the 2008 PQRI on the basis of AQA adoption were considered and specifically declined for endorsement by NQF on or before August 31, 2008 and therefore are not included in the final measure set for the 2009 PQRI:

Measure 73 Cancer: Plan for Chemotherapy

Documented

Measure 77 Gastroesophageal Reflux Disease

(GERD): Assessment of GERD Symptoms in Patients Receiving Chronic

Medication for GERD

Measure 78 ESRD: Vascular Access for Patients

Undergoing Hemodialysis

Measure 101 Prostate Cancer: Appropriate Initial

Evaluation

Measure 132 Patient Co-Development of Treatment

Plan/Plan of Care.

Page 69838

As described in sections II.O2. and III. of this final rule with comment period, the MIPPA authorized a new incentive program for successful electronic prescribers. As a result, section 1848(m)(3)(A) of the Act, as redesignated by section 131(b)(3)(C) of the MIPPA and amended by section 131(b)(3)(D)(iii) of the MIPPA for 2009 and subsequent years, specifies that the PQRI quality measures shall not include electronic prescribing measures. Therefore, Measure 125 HIT: Adoption/Use of Medication e-Prescribing is not included in the final set of 2009 PQRI quality measures. This measure will instead be used for the new e-prescribing incentive program authorized by MIPPA as discussed in section II.O2.

Lastly, we are not finalizing the following proposed measures included in the 2008 PQRI primarily because our analysis of the 2007

PQRI results indicate that there were no satisfactory submissions and no quality data codes accepted for these measures during the 2007 PQRI:

Measure 96 OME: Antihistamines or Decongestants--

Avoidance of Inappropriate Use

Measure 97 OME: Systemic Antimicrobials--

Avoidance of Inappropriate Use

Measure 98 OME: Systemic Corticosteroids--

Avoidance of Inappropriate Use

Measure 120 CKD: ACE/ARB Therapy.

With respect to Measures 96 through 98, we also believe that eligible professionals would be unlikely to voluntarily report inappropriate actions. With respect to Measure 120, our analysis of the 2007 PQRI results revealed that the measure requires multiple diagnosis codes.

Please note that detailed measure specifications for 2008 PQRI quality measures may have been updated or modified during the NQF endorsement process or for other reasons prior to 2009. The 2009 PQRI quality measure specifications for any given quality measure may, therefore, be different from specifications for the same quality measure used for 2008. Specifications for all 2009 PQRI quality measures, whether or not included in the 2008 PQRI program, must be obtained from the specifications document for 2009 PQRI quality measures, which will be available on the PQRI section of the CMS Web site on or before December 31, 2008.

As stated above, there are 5 measures listed in Table 15 that can be reported only via a registry for the 2009 PQRI and, therefore, are not reportable via claims-based reporting. ii. Additional NQF-Endorsed Measures

We proposed to include in the 2009 PQRI quality measure set 17 new measures endorsed by the NQF but that were not included in the 2008

PQRI quality measures. We received several comments on the 17 proposed additional NQF-endorsed measures, which are summarized and addressed below.

Comment: We received several comments in support of the proposed additional NQF-endorsed measures. Comments were received specifically in support of the following measures:

Anti-platelet Medications at Discharge.

Hemodialysis Vascular Access Decision-making by Surgeons to Maximize Placement of Autogeneous Arterial Venous Fistula.

One commenter, also the measure's developer, recommended the removal of the proposed measure ``Use of Imaging Studies in Low Back

Pain'' and noted that this measure does not share a common denominator with the other measures within the Back Pain measures group.

Response: We concur with the comments in support of the proposed additional NQF-endorsed measures. However, for the reasons recommended by the measure developer the proposed measure ``Use of Imaging Studies in Low Back Pain'' has been removed from the 2009 PQRI quality measures set.

For the 2009 PQRI quality measure set, we are finalizing 15 of the 17 proposed measures that were endorsed by the NQF but were not included in the 2008 PQRI quality measures. These 17 measures are identified in Table 16. Besides having NQF endorsement, these measures were considered ready for implementation for the purposes of the 2009

PQRI as of October 15, 2008 based on the following--(1) the final, detailed specifications for use in data collection for PQRI have been completed and are ready for implementation, and (2) all of the Category

II Current Procedural Terminology (CPT II) codes required for the measure to be reported by claims have been established and will be effective for CMS claims data submission on or before January 1, 2009.

Table 16--Final Additional NQF-Endorsed Measures

Measure title

Measure source

Osteoarthritis (OA): Assessment for Use of AMA-PCPI.

Anti-Inflammatory or Analgesic Over-the-

Counter (OTC) Medications.

Back Pain: Initial Visit................... NCQA.

Back Pain: Physical Exam................... NCQA.

Back Pain: Advice for Normal Activities.... NCQA.

Back Pain: Advice Against Bed Rest......... NCQA.

Diabetes Mellitus: Foot Exam............... NCQA.

Coronary Artery Bypass Graft (CABG):

STS.

Prolonged Intubation (Ventilation)\+\.

Coronary Artery Bypass Graft (CABG): Deep

STS.

Sternal Wound Infection Rate\+\.

Coronary Artery Bypass Graft (CABG): Stroke/ STS.

Cerebrovascular Accident (CVA)\+\.

Coronary Artery Bypass Graft (CABG): Post- STS. operative Renal Insufficiency\+\.

Coronary Artery Bypass Graft (CABG):

STS.

Surgical Re-exploration\+\.

Coronary Artery Bypass Graft (CABG): Anti- STS. platelet Medications at Discharge\+\.

Coronary Artery Bypass Graft (CABG): Beta

STS.

Blockade at Discharge\+\.

Coronary Artery Bypass Graft (CABG): Lipid STS.

Management and Counseling\+\.

Hemodialysis Vascular Access Decision-

Society for Vascular

Making by Surgeons To Maximize Placement

Surgeons (SVS). of Autogenous Arterial Venous Fistula.

\+\ This measure is reportable only via registry-based reporting and is not reportable via claims-based reporting.

As previously mentioned in this final rule, we are not finalizing the proposed measure, Use of Imaging Studies in Low Back Pain, in the final 2009 PQRI quality measures set listed in Table 16 based on comments received.

Page 69839

In addition, we are not finalizing the following proposed NQF- endorsed measure in the final 2009 PQRI measures because its adaptation to the PQRI format was subsequently found to be not feasible: Selection of Antibiotic Administration for Cardiac Surgery Patients. Substantive components of this measure are duplicative of Measure 21

Perioperative Care: Selection of Prophylactic Antibiotic--First OR

Second Generation Cephalosporin, which is listed in Table 15.

As stated above, there are 8 measures listed in Table 16 that can be reported only via a registry for the 2009 PQRI and, therefore, are not reportable via claims-based reporting.

As described in the CY 2009 PFS proposed rule (73 FR 38570), measures designated as Tin the proposed rule indicated that the measure was included in the 2008 Measure

Testing Process. The Tidentifier was removed from Table 16 in this final rule with comment because each measure in the final 2009 PQRI quality measures set will be assigned a unique number which may be obtained from the detailed specifications which will be made available on the PQRI section of the CMS Web site no later than December 31, 2008. iii. Additional AQA Adopted Measures

As discussed in the CY 2009 PFS proposed rule (73 FR 38565 through 38566), in circumstances where no NQF-endorsed measure is available, a quality measure that has been adopted by the AQA would also meet the requirements of section 1848(k)(2)(B)(i) of the Act. As such, we proposed 21 new measures adopted by the AQA that had not yet been reviewed or endorsed by the NQF at the time the CY 2009 PFS proposed rule was published and that were not included in the final set of 2008

PQRI quality measures (73 FR 38571).

We received numerous comments on the 21 proposed additional AQA- adopted measures, which are summarized and addressed below.

Comment: Numerous commenters were in support of the inclusion of the following proposed additional AQA-adopted measures in the final 2009 PQRI measures:

T138 Melanoma: Coordination of Care.

T139 Cataracts: Cataracts: Comprehensive Preoperative

Assessment for Cataract Surgery with Intraocular Lens (IOL) Placement.

T140 Age-Related Macular Degeneration (AMD): Counseling on

Antioxidant Supplement.

T141 Primary Open-Angle Glaucoma (POAG): Reduction of

Intraocular Pressure (IOP) by 15 percent OR Documentation of a Plan of

Care.

T143 Oncology: Medical and Radiation--Plan of Care for

Pain.

Oncology: Medical and Radiation-Pain Intensity Quantified.

Oncology: Recording of Clinical Stage for Lung Cancer and

Esophageal Cancer.

However, we received 2 comments specifically suggesting that the proposed measure, T144 Radiology: Computed Tomography (CT) Radiation

Dose Reduction, not be finalized as part of the 2009 PQRI quality measures for failure to achieve a recommendation for endorsement by the

NQF Steering Committee on Outpatient Imaging Efficiency.

Response: As suggested by commenters Measure T144 Radiology:

Computed Tomography (CT) Radiation Dose Reduction will not be finalized as part of the 2009 PQRI quality measures set because the measure was specifically reviewed by NQF on or before August 31, 2008 but declined for endorsement. All other additional AQA-adopted measures specifically supported by commenters are being finalized for the 2009 PQRI.

We are including in the final 2009 PQRI quality measure set 19 of the 21 proposed measures adopted by AQA that had not yet been reviewed or endorsed by the NQF at the time the CY 2009 PFS proposed rule was published and that were not included in the final set of 2008 PQRI quality measures. These measures are identified in Table 17.

Table 17--Final Additional AQA-Adopted Measures

Measure title

Measure source

Chronic Kidney Disease (CKD):

AMA-PCPI.

Influenza Immunization.

Melanoma: Follow-Up Aspects of Care.. AMA-PCPI/NCQA.

Melanoma: Continuity of Care--Recall AMA-PCPI/NCQA.

System.

Melanoma: Coordination of Care....... AMA-PCPI/NCQA.

Cataracts: Comprehensive Preoperative AMA-PCPI/NCQA.

Assessment for Cataract Surgery with

Intraocular Lens (IOL) Placement.

Age-Related Macular Degeneration

AMA-PCPI/NCQA.

(AMD): Counseling on Antioxidant

Supplement.

Primary Open-Angle Glaucoma (POAG) : AMA-PCPI/NCQA.

Reduction of Intraocular Pressure

(IOP) by 15% OR Documentation of a

Plan of Care.

Oncology: Medical and Radiation--Plan AMA-PCPI. of Care for Pain.

Radiology: Exposure Time Reported for AMA-PCPI/NCQA.

Procedures Using Fluoroscopy.

Oncology: Medical and Radiation--Pain AMA-PCPI.

Quantified.

Radiology: Inappropriate Use of

AMA-PCPI.

``Probably Benign'' Assessment

Category in Mammography Screening.

Coronary Artery Disease (CAD): Lipid AMA-PCPI.

Profile in Patients with CAD.

Chronic Kidney Disease (CKD):

AMA-PCPI.

Referral for Arteriovenous (AV)

Fistula.

Falls: Plan of Care.................. AMA-PCPI.

Falls: Risk Assessment............... AMA-PCPI.

Oncology: Radiation Dose Limits to

AMA-PCPI.

Normal Tissues.

Hepatitis C: Hepatitis A Vaccination. AMA-PCPI.

Hepatitis C: Hepatitis B Vaccination. AMA-PCPI.

Oncology: Recording of Clinical Stage STS. for Lung Cancer and Esophageal

Cancer.

The following proposed measures are not included in the final 2009

PQRI quality measure set because they were reviewed by NQF on or before

August 31, 2008 and were not recommended for endorsement:

Measure T144 Radiology: Computed Tomography (CT) Radiation

Dose Reduction; and

Osteoporosis: Counseling for Vitamin D, Calcium Intake, and Exercise.

Besides being adopted by the AQA, the measures we finalized were considered ready for implementation for the purposes of the 2009 PQRI as of October 15, 2008 based on the following--(1) the final, detailed

Page 69840

specifications for use in data collection for PQRI have been completed and are ready for implementation, and (2) all of the CPT II codes required for the measure to be reported by claims have been established and will be effective for CMS claims data submission on or before

January 1, 2009.

As described in section III.O.4.b, measures designated as

Tin the proposed rule indicated that the measure was included in the 2008 Measure Testing Process. The

Tidentifier was removed from Table 17 in the final rule with comment period because each measure in the final 2009 PQRI measure set will be assigned an unique number which may be obtained from the detailed specifications which will be made available on the PQRI section of the CMS Web site no later than

December 31, 2008. iv. Additional Measures Selected Contingent upon NQF Endorsement or AQA

Adoption by August 31, 2008

We proposed to include in the 2009 PQRI quality measure set 26 new measures that had not yet received NQF endorsement or AQA adoption at the time of the publication of the proposed rule but whose selection was contingent on NQF endorsement and/or AQA adoption by August 31, 2008 (73 FR 38571 through 38572).

We received several comments on these 26 proposed measures, which are summarized and addressed below.

Comment: Several commenters were in support of the following proposed measures that have since been NQF endorsed and/or AQA adopted as of August 31, 2008:

Nuclear Medicine: Correlation with Existing Imaging

Studies for all Patients Undergoing Bone Scintigraphy; and

Preventive Care and Screening: Unhealthy Alcohol Use--

Screening & Brief Counseling.

One commenter, also the measure's developer, noted that the proposed measure Lipid Screening is not available for use in the 2009

PQRI. Several commenters stated the following proposed measures do not represent standards of care and have technical issues and therefore, opposed inclusion of these measures in the final 2009 PQRI measure set:

Rheumatoid Arthritis: Appropriate Use of Biologic Disease

Modifying Anti-Rheumatic Drugs (DMARDs);

Chronic Wound Care: Offloading of Diabetic Foot Ulcers;

Diabetes Mellitus: Diabetic Foot and Ankle Care,

Peripheral Arterial Disease--Ankle Brachial Index; and

Palliative Care: Dyspnea Screening and Management.

Response: The final 2009 PQRI measures have been selected based upon the following criteria as stated in the proposed rule:

Achievement of NQF endorsement or AQA adoption by August 31, 2008;

Readiness for implementation for the purposes of the 2009

PQRI if by October 15, 2008--(1) the final, detailed specifications for use of the measure in data collection for PQRI have been completed and are ready for implementation, and (2) all of the CPT II codes required for the measure to be reported by claims have been established and will be effective for CMS claims based submission on or before January 1, 2009; and

Proposed for use in the 2009 PQRI in the CY 2009 PFS proposed rule with an opportunity for public comment via the rulemaking process.

As identified in Table 18, we are including in the final 2009 PQRI quality measure set 18 of 26 proposed measures that were contingent upon NQF endorsement or AQA adoption by August 31, 2008.

Table 18--Final Measures Selected for 2009 Contingent Upon NQF

Endorsement or AQA Adoption by August 31, 2008

Measure title

Measure source

Nuclear Medicine: Correlation with

AMA-PCPI.

Existing Imaging Studies for all

Patients Undergoing Bone

Scintigraphy.

Preventive Care and Screening:

AMA-PCPI.

Unhealthy Alcohol Use--Screening &

Brief Counseling.

Pediatric ESRD: Adequacy of

AMA-PCPI.

Hemodialysis\+\.

Pediatric ESRD: Influenza

AMA-PCPI.

Immunization.

Rheumatoid Arthritis: Tuberculosis

AMA-PCPI/NCQA.

Screening.

Rheumatoid Arthritis: Periodic

AMA-PCPI/NCQA.

Assessment of Disease Activity.

Rheumatoid Arthritis: Functional

AMA-PCPI/NCQA.

Limitation Assessment.

Rheumatoid Arthritis: Assessment and AMA-PCPI/NCQA.

Classification of Disease Prognosis.

Rheumatoid Arthritis: Glucocorticoid AMA-PCPI/NCQA.

Management.

Endoscopy & Polyp Surveillance:

AMA-PCPI/NCQA.

Surveillance Colonoscopy Interval in

Patients with History of Adenomatous

Polyps.

Wound Care: Use of Compression System AMA-PCPI/NCQA. in Patients with Venous Ulcers.

HIV/AIDS: CD4\+\ Cell Count or CD4+

AMA-PCPI/NCQA.

Percentage\+\.

HIV/AIDS: Pneumocystis Jiroveci

AMA-PCPI/NCQA.

Pneumonia (PCP) Prophylaxis+.

HIV/AIDS: Adolescent and Adult

AMA-PCPI/NCQA.

Patients with HIV/AIDS who are

Prescribed Potent Antiretroviral

Therapy\+\.

HIV/AIDS: HIV RNA Control After 6

AMA-PCPI/NCQA.

Months of Potent Antiretroviral

Therapy\+\.

Elder Maltreatment Screen and Follow- QIP/CMS. up Plan.

Functional Outcome Assessment in

QIP/CMS.

Chiropractic Care.

Endarterectomy: Use of Patch During

SVS.

Conventional Endarterectomy.

\+\ This measure is reportable only via registry-based reporting and is not reportable via claims-based reporting.

These measures were selected based on the comments received, whether the measure received NQF endorsement and/or AQA adoption by

August 31, 2008, and whether the measure was ready for implementation by October 15, 2008. A measure was considered ready for implementation for the purposes of the 2009 PQRI if by October 15, 2008--(1) the final, detailed specifications for use of the measure in data collection for PQRI have been completed and are ready for implementation, and (2) all of the CPT II codes required for the measure have been established and will be effective for CMS claims based submission on or before January 1, 2009.

These additional measures augment the opportunity for eligible professionals to submit quality data under the PQRI where there were limited measures. These additional measures include the addition of measures for nuclear medicine services, pediatric ESRD services, rheumatoid arthritis services, gastroenterology services, wound care, and chiropractic services.

The following proposed measures are not included in the final set of 2009

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PQRI quality measures listed in Table 18 because they did not achieve

NQF endorsement or AQA adoption as of August 31, 2008:

Chronic Wound Care: Offloading of Diabetic Foot Ulcers;

Diabetes Mellitus: Diabetic Foot and Ankle Care,

Peripheral Arterial Disease--Ankle Brachial Index; and

Endarterectomy: Perioperative Stroke or Death in

Asymptomatic Patient Undergoing Carotid Endarterectomy (CEA).

The following proposed measures are not included in the final set of 2009 PQRI quality measures listed in Table 18 because they were not ready for implementation by October 15, 2008:

Lipid Screening;

Rheumatoid Arthritis: Appropriate Use of Biologic Disease

Modifying Anti-Rheumatic Drugs (DMARDs); and

Participation by Physician or Other Clinician in a

Systematic Clinical Database Registry that includes Consensus Endorsed

Quality Measures.

That is, by October 15, 2008, (1) the final, detailed specifications for use of the measure in data collection for PQRI have not been completed and/or are not ready for implementation, or (2) all of the CPT II codes required for the measure to be reported by claims have not been established and/or will not be effective for CMS claims based submission on or before January 1, 2009.

In addition, we did not include in the final set of PQRI measures listed in Table 18 the following proposed measures that subsequently were adopted by the AQA, because their adaptation to the PQRI format was subsequently found to be not feasible:

Palliative Care: Dyspnea Screening and Management.

Finally, we did not include in the final PQRI measures listed in

Table 18 the following proposed measure:

Endarterectomy: Peri-operative Anti-platelet Therapy for

Patients Undergoing Carotid Endarterectomy (CEA)

We did not include this measure in the final 2009 PQRI quality measures set for many reasons. First, this measure is not reportable through claims submission. The SVS did not self-nominate to become a qualified registry for the 2008 PQRI and the SVS registry is not currently collecting this measure. In addition, we are not aware of any other registries collecting this measure.

As stated above, however, there are 5 measures listed in Table 18 that can be reported only via a registry for the 2009 PQRI, and therefore, are not reportable via claims-based reporting. v. Measures Selected for Inclusion in 2009 Measures Groups

As discussed in the CY 2009 PFS proposed rule, we proposed to retain three of the four 2008 PQRI measures groups for the 2009 PQRI--

(1) Diabetes Mellitus, (2) CKD, and (3) Preventive Care. The measures proposed for inclusion in the 2009 Diabetes Mellitus, CKD, and

Preventive Care measures groups were identified in the CY 2009 PFS proposed rule (73 FR 38572 through 38573).

In addition to these three proposed measures groups retained from 2008 with applicable modifications, there were six new measures groups proposed for the 2009 PQRI: (1) CABG Surgery; (2) CAD; (3) Rheumatoid

Arthritis; (4) HIV/AIDS; (5) Perioperative Care; and (6) Back Pain.

Each of the measures groups was proposed to contain at least four PQRI quality measures. Except for the Back Pain measures group, it was proposed that all measures included in a measures group could be reported individually or as part of a group. Measures in the Back Pain measures group were proposed to be reportable only as a part of this measures group.

In the CY 2009 PFS proposed rule (73 FR 38560), we invited comments on the proposed new measures groups, including suggestions for other measures groups based on individual measures included in the proposed 2009 PQRI measure set. We explained that for the 2009 PQRI, measures groups must contain at least 4 measures and asked that all measures in each measures group suggested by commenters be included in the list of measures proposed in the CY 2009 PFS proposed rule (73 FR 38567 through 38572). We explained that the individual measures included in the final measures groups for the 2009 PQRI will be limited to those which are included in the final set of measures for the 2009 PQRI, as identified below.

We received numerous comments on the proposed measures groups, which are summarized and addressed as follows.

Comment: Many commenters suggested that we create a composite code for reporting all of the aspects of care within a measures group. One commenter specifically recommended that the CABG Surgery measures group be limited to a smaller number of measures unless a composite code is created for all aspects of care in the measures proposed for inclusion in the CABG Surgery measures group.

Response: We continue to seek methods to simplify reporting and increase participation in PQRI. We agree with this suggestion and have taken the necessary steps to develop composite codes for reporting all of the aspects of care within a measures group. This composite code will aid to simplify and allow for ease of reporting for those eligible professionals who elect to report a measures group. The measures groups' specifications document will be updated to include composite codes. No later than December 31, 2008, we will post the detailed specifications and specific instructions for reporting measures groups on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/pqri.

Comment: We received numerous comments suggesting additional measures groups. Examples of measures groups' topics suggested by commenters include, but are not limited to, geriatrics, hepatitis C, respiratory, ischemic vascular disease (IVD), cardiovascular disease and stroke care, stroke treatment, osteoporosis, and oral drug therapy.

One commenter noted that the proposed measures groups are applicable to physicians only and encouraged us to consider other eligible professionals as new measures groups are identified. Some commenters suggested specific measures for inclusion in their suggested measures groups, but many commenters did not suggest specific groups of at least 4 measures.

Response: While we welcome the additional measures groups suggested by commenters, we are not able to consider such additional measures groups for inclusion in the 2009 PQRI since there is no opportunity for public comment on the measures groups' potential inclusion in the 2009

PQRI. However, to the extent that commenters suggested specific measures for inclusion in a particular measures group, we will take the commenters' suggestions into consideration for purposes of identifying measures groups for possible inclusion in future years' PQRI.

As stated in the CY 2009 PFS proposed rule (73 FR 38560), each measures group suggested by commenters must contain at least 4 measures and must consist of the proposed measures cited in section II.O.4. of the proposed rule, ``Proposed 2009 PQRI Quality Measures.'' The measures groups must have a particular clinical condition or focus in common, as identified by the denominator definition and coding of the measures groups.

We encourage professional organizations and measure developers to engage in the development of measures groups, including measures

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groups that are applicable to other nonphysician professionals. We will continue working with stakeholders to fill gaps for measures groups.

Comment: We received multiple suggestions for altering the proposed measure groups.

Response: As stated previously, we requested in the CY 2009 PFS proposed rule that suggestions for new measures groups or measures included in a particular measures group, must be based on individual measures included in the proposed 2009 PQRI quality measure set. In response to the suggestions provided by commenters, the Use of Imaging

Studies in Low Back Pain measure has been removed from the Back Pain measures group due to the frequency for the process of care being inconsistent with the other measures in this measures group. No new measures groups have been established outside of what was included in the CY 2009 PFS proposed rule. However, we encourage professional organizations and measure developers to engage in the development of measure groups. We plan to continue working with stakeholders to fill gaps for measures groups.

Comment: Several commenters recommended retaining the ESRD Measures

Group for the 2009 PQRI by replacing the 2008 PQRI Measure 80:

Plan of Care for ESRD Patients with Anemia which was declined for NQF endorsement with the proposed 2009 PQRI Measure 82 ESRD: Plan of Care for Inadequate Peritoneal Dialysis listed in section II.O1.d. of this final rule, ``The Final 2009 PQRI Quality Measures.''

Response: As stated in the proposed rule (73 FR 38560), the ESRD measures groups is not being included in the 2009 PQRI because one of the measures in the group is no longer NQF-endorsed. The denominator definition and coding of the ESRD measures proposed and selected for the 2009 PQRI do not meet the requirements for a measures group as stated in section II.O1.b.ii. of this final rule with comment period.

However, the proposed 2009 PQRI Measure 82 ESRD: Plan of Care for Inadequate Peritoneal Dialysis is available to be reported as an individual quality measure in the 2009 PQRI.

Based on the comments we received, we are retaining three 2008 PQRI measures groups for the 2009 PQRI--(1) Diabetes Mellitus, (2) CKD, and

(3) Preventive Care. In some cases, different or additional measures may be selected for inclusion in a particular measures group for use in 2009, compared to 2008. Therefore, the composition of the Diabetes

Mellitus, CKD, and Preventive Care measures groups may be different for the 2009 PQRI than for the 2008 PQRI. The measures selected for inclusion in the 2009 Diabetes Mellitus, CKD, and Preventive Care measures groups are listed in Tables 19 through 21.

Some measures selected for inclusion in a 2009 measures group are current 2008 PQRI measures. The title of each such measure is preceded with its PQRI Measure Number in Tables 19 through 25. The PQRI Measure

Number is a unique identifier assigned by CMS to all measures in the

PQRI measure set. Once a PQRI Measure Number is assigned to a measure, it will not be used again, even if the measure is subsequently retired from the PQRI measure set. Measures that are not preceded by a number have never been part of a PQRI measure set until now. A number will be assigned to such measures for the 2009 PQRI. As with measures group reporting in the 2008 PQRI, each eligible professional electing to report a group of measures for 2009 must report all measures in the group that are applicable to each patient or encounter to which the measures group applies at least up to the minimum number of patients required by applicable reporting criteria (described above in section

II.O1.b.ii.).

Table 19--Final Measures Selected for 2009 Diabetes Mellitus Measures

Group

Measure title

Measure source

1. Diabetes Mellitus: Hemoglobin A1c NCQA.

Poor Control in Diabetes Mellitus. 2. Diabetes Mellitus: Low Density

NCQA.

Lipoprotein (LDL-C) Control in

Diabetes Mellitus. 3. Diabetes Mellitus: High Blood

NCQA.

Pressure Control in Diabetes

Mellitus. 117. Diabetes Mellitus: Dilated Eye

NCQA.

Exam in Diabetic Patient. 119. Diabetes Mellitus: Urine

NCQA.

Screening for Microalbumin or

Medical Attention for Nephropathy in

Diabetic Patients.

Diabetes Mellitus: Foot Exam......... NCQA.

Table 20--Final Measures Selected for 2009 CKD Measures Group

Measure title

Measure source

121. Chronic Kidney Disease (CKD):

AMA-PCPI.

Laboratory Testing (Calcium,

Phosphorus, Intact Parathyroid

Hormone (iPTH) and Lipid Profile). 122. Chronic Kidney Disease (CKD):

AMA-PCPI.

Blood Pressure Management. 123. Chronic Kidney Disease (CKD):

AMA-PCPI.

Plan of Care: Elevated Hemoglobin for Patients Receiving

Erythropoiesis--Stimulating Agents

(ESA).

Chronic Kidney Disease (CKD):

AMA-PCPI.

Referral for Arteriovenous AV)

Fistula.

Chronic Kidney Disease (CKD):

AMA-PCPI.

Influenza Immunization.

Table 21--Final Measures Selected for 2009 Preventive Care Measures

Group

Measure title

Measure source

39. Screening or Therapy for

AMA-PCPI/NCQA.

Osteoporosis for Women Aged 65 Years and Older. 48. Urinary Incontinence: Assessment AMA-PCPI/NCQA. of Presence or Absence of Urinary

Incontinence in Women Aged 65 Years and Older. 110. Preventive Care and Screening:

AMA-PCPI.

Influenza Immunization for Patients

gteqt

50 Years Old. 111. Preventive Care and Screening:

NCQA.

Pneumonia Vaccination for Patients 65 Years and Older. 112. Preventive Care and Screening:

NCQA.

Screening Mammography. 113. Preventive Care and Screening:

NCQA.

Colorectal Cancer Screening. 114. Preventive Care and Screening:

AMA-PCPI.

Inquiry Regarding Tobacco Use.

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115. Preventive Care and Screening:

NCQA.

Advising Smokers to Quit. 128. Preventive Care and Screening:

QIP/CMS.

Body Mass Index (BMI) Screening and

Follow-Up.

In addition to the three measures groups retained from 2008 with applicable modifications, there are four new measures groups that we are finalizing for the 2009 PQRI: (1) CABG Surgery; (2) Rheumatoid

Arthritis; (3) Perioperative Care; and (4) Back Pain. Each of the measures groups contains at least four PQRI measures.

Tables 22 through 25 lists the measures selected for inclusion in each of these new measures groups.

Table 22--Final Measures Selected for 2009 CABG Measures Group

Measure title

Measure source

43. Coronary Artery Bypass Graft

STS.

(CABG): Use of Internal Mammary

Artery (IMA) in Isolated CABG

Surgery. 44. Coronary Artery Bypass Graft

STS.

(CABG): Preoperative Beta-Blocker in

Patients with Isolated CABG Surgery.

Coronary Artery Bypass Graft (CABG): STS.

Prolonged Intubation (Ventilation)

\+\.

Coronary Artery Bypass Graft (CABG): STS.

Deep Sternal Wound Infection Rate

\+\.

Coronary Artery Bypass Graft (CABG): STS.

Stroke/Cerebrovascular Accident

(CVA) \+\.

Coronary Artery Bypass Graft (CABG): STS.

Post-operative Renal Insufficiency

\+\.

Coronary Artery Bypass Graft (CABG): STS.

Surgical Re-exploration \+\.

Coronary Artery Bypass Graft (CABG): STS.

Anti-platelet Medications at

Discharge \+\.

Coronary Artery Bypass Graft (CABG): STS.

Beta Blockers Administered at

Discharge \+\.

Coronary Artery Bypass Graft (CABG): STS.

Lipid Management and Counseling \+\.

\+\ This measure is reportable only via registry-based reporting and is not reportable via claims-based reporting.

Table 23--Final Measures Selected for 2009 Rheumatoid Arthritis Measures

Group

Measure title

Measure source

108. Rheumatoid Arthritis: Disease

NCQA.

Modifying Anti-Rheumatic Drug

(DMARD) Therapy.

Rheumatoid Arthritis: Tuberculosis

AMA-PCPI/NCQA.

Screening.

Rheumatoid Arthritis: Periodic

AMA-PCPI/NCQA.

Assessment of Disease Activity.

Rheumatoid Arthritis: Functional

AMA-PCPI/NCQA.

Limitation Assessment.

Rheumatoid Arthritis: Assessment and AMA-PCPI/NCQA.

Classification of Disease Prognosis.

Rheumatoid Arthritis: Glucocorticoid AMA-PCPI/NCQA.

Management.

Table 24--Final Measures Selected for 2009 Perioperative Care Measures

Group

Measure title

Measure source

20. Perioperative Care: Timing of

AMA-PCPI/NCQA.

Antibiotic Prophylaxis--Ordering

Physician. 21. Perioperative Care: Selection of AMA-PCPI/NCQA.

Prophylactic Antibiotic--First OR

Second Generation Cephalosporin. 22. Perioperative Care:

AMA-PCPI/NCQA.

Discontinuation of Prophylactic

Antibiotics (Non-Cardiac Procedures). 23. Perioperative Care: Venous

AMA-PCPI/NCQA.

Thromboembolism (VTE) Prophylaxis

(When Indicated in ALL Patients).

Table 25--Final Measures Selected for 2009 Back Pain Measures Group

Measure title

Measure source

Back Pain: Initial Visit............. NCQA.

Back Pain: Physical Exam............. NCQA.

Back Pain: Advice for Normal

NCQA.

Activities.

Back Pain: Advice Against Bed Rest... NCQA.

We are not finalizing the proposed CAD and HIV/AIDS measures groups. Analysis of the proposed CAD measures group has revealed difficulty with determining a common denominator and that two of the four measures within this measures group would require additional diagnosis codes in order to be applicable for the group. Analysis of the proposed HIV/AIDS measures group has revealed several barriers for establishing the common denominator and the consecutive patient determination. While these are meaningful individual quality measures, we believe that the issues as stated make it impractical to use these measures as measures groups.

The measures in the Diabetes Mellitus; CKD; Preventive Care;

Rheumatoid Arthritis, and Perioperative Care measures groups are reportable either individually or as part of the measures group. The measures in these measures groups can be reported through claims-based or registry-based submission.

The measures in the Back Pain measures group are reportable only as a measures group, not as individual

Page 69844

measures. As individual measures, the measures in the Back Pain measures group are too basic; however, taken together they are meaningful indicators of quality of care for back pain. These measures are also reportable through claims-based or registry-based submission.

Eight measures in the CABG surgery measures group are reportable only via registry-based reporting as a measures group or as individual measures. These measures cannot be reported through claims-based reporting because they cannot be feasibly specified for claims-based reporting.

In addition, as discussed above, we did not finalize Measure 120 CKD: ACE/ARB Therapy in the 2009 PQRI. Therefore, we are removing Measure 120 from the CKD Measures Group and are instead replacing Measure 120 with the following 2 measures from Table 17:

CKD: Referral for AV Fistula.

CKD: Influenza Immunization.

Analysis of Measure 120 revealed that the measure requires multiple diagnosis codes, which is inconsistent with the other measures in the CKD Measures Group.

As noted in the CY 2009 PFS proposed rule (73 FR 38560), the detailed measure specifications and instructions for submitting data on those 2009 measures groups that were also included as 2008 PQRI measures groups may be updated or modified prior to 2009. Therefore, the 2009 PQRI measure specifications for any given measures group could be different from specifications and submission instructions for the same measures group used for 2008. These measure specification changes do not materially impact the intended meaning of the measures or the strength of the measures. Additionally, the specifications for measures groups would not necessarily contain all the specification elements of each individual measure making up the measures group. This is based on the need for a common set of denominator specifications for all the measures making up a measures group in order to define the applicability of the measures group. Therefore, the specifications and instructions for measures groups will be provided separately from the specifications and instructions for the individual 2009 PQRI measures.

We will post the detailed specifications and specific instructions for reporting measures groups on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/pqri by no later than December 31, 2008. e. Uses of PQRI Information i. Overview and Summary

In the CY 2009 PFS proposed rule (73 FR 38574 through 38575) we indicated that we are contemplating a ``Physician Compare'' Web site similar to other Web pages we currently have at http://www.medicare.gov for the public reporting of quality data for hospitals (Hospital

Compare), dialysis facilities (Dialysis Facility Compare), nursing homes (Nursing Home Compare) and home health facilities (Home Health

Compare) by enhancing the information found on the Physician and Other

Healthcare Professional Directory (see http://www.medicare.gov/

Physician/Home.asp?bhcp=1) to include information about the quality of care and value for services provided by professionals to Medicare beneficiaries. There are a variety of data sources that could provide quality of care, value, and other information for services provided by professionals to Medicare beneficiaries that could be used to develop a

Physician Compare Web site. As we indicated in the proposed rule, the data on PQRI quality measures that is submitted at the individual (that is, NPI) level by physicians and other eligible professionals could be the basis for public reporting of quality measurement performance results at either the individual or group (that is, TIN) level. We also indicated that as part of our broader goal to measure and make the quality of care for services furnished to Medicare beneficiaries publicly available and in support of the four cornerstones for value- driven health care (that is, connecting the health system through the use of interoperable health information technology; measuring and publishing information about quality; measuring and publishing information about price; and using incentives to promote high-quality and cost-effective care), we anticipate making information on the quality of care for services furnished by professionals to Medicare beneficiaries publicly available in the future. We also indicated that we anticipate exploring the use of information collected from the PQRI, including performance results, for this purpose. To assist us in determining the most appropriate uses of PQRI data, we invited comments on the following issues:

Ways to effectively engage eligible professionals, consumers, and other stakeholders in the development and evaluation of a valid and reliable public reporting system related to professional services provided to Medicare beneficiaries.

The venue and format for how PQRI information should be made publicly available.

Types of data that would be most useful and meaningful to consumers (for example, reporting results and/or performance results).

Types of data that would be most useful and meaningful for professionals.

Level at which PQRI information should be publicly reported (that is, at the individual professional, or NPI, level or the group, or TIN, level).

Types of PQRI measures and/or measures groups that would be most useful and meaningful to consumers.

Types of PQRI measures and/or measures groups that would be most useful and meaningful to professionals.

Review of the data to be publicly reported by eligible professionals.

In addition, subsequent to the publication of the CY 2009 PFS proposed rule, section 1848(m)(5)(G) of the Act, as added by the MIPPA and described in section III. of this final rule with comment period, requires the Secretary to post on the CMS Web site, in an easily understandable format, a list of the names of eligible professionals

(or group practices) who satisfactorily submitted data on quality measures for the PQRI and the names of the eligible professionals (or group practices) who are successful electronic prescribers as defined and discussed further below in section II.O2. This requirement, however, cannot be applied retrospectively to data that was collected prior to the enactment of the MIPPA. ii. Summary of Comments and Responses

The following is a summary of the comments we received and our responses.

Comment: A few commenters expressed general support for publicly reporting physician performance and/or participation information and applauded CMS' efforts to assist beneficiaries in making informed decisions when choosing a health care provider. One commenter noted that although reporting performance information back to providers is an important first step, rapidly reporting performance information to the public is critical for informed decision-making by consumers and purchasers. Some commenters also expressed support for making specific types of information public about eligible professionals. Examples of information that commenters would like to see made public include, but are not limited to, board certification status and certification maintenance status, adding

Page 69845

hospital medicine to the list of specialties contained in the Physician and Other Healthcare Professional Directory, CAHPS patient survey data, an indicator of whether an eligible professional participates in a clinical data registry, and the numerators and denominators for any measure rates that are publicly reported.

Response: We are pleased to have the commenters' support for our broader goal to make information on physician performance publicly available. We agree that such information may be relevant and useful to a broad audience. Physicians and other eligible professionals can use information about their own performance and the performance of their peers to improve the quality of the care they deliver. Medicare beneficiaries and other consumers can use such information to inform their decision-making when it comes to selecting their health care providers. We note, however, that much of the information that commenters specifically requested be made public is beyond the scope of this final rule with comment period, which is limited to the public disclosure of PQRI information.

Comment: A few commenters suggested that we limit public reporting of PQRI information to the names of the clinicians and/or group practices that satisfactorily participated and earned an incentive payment.

Response: As stated previously, the MIPPA requires us to list the names of eligible professionals (or group practices) who satisfactorily submitted data on quality measures for the PQRI on our Web site. While we agree that information on who satisfactorily submits data on quality measures for the PQRI is useful information to have and plan to list only the names of physicians who satisfactorily participated in the 2009 PQRI and earned an incentive payment, it is our goal to eventually make performance information public as well. We have made information on quality of care in other care settings publicly available and hope to eventually do the same for physicians and other health care practitioners as part of our broader goal to measure and make the quality of care for services furnished to Medicare beneficiaries publicly available.

Comment: Several commenters felt that it would be premature to publicly report any information derived from PQRI at this time. Other commenters merely urged CMS to proceed cautiously when creating a

Physician Compare Web site using PQRI data. Although some commenters supported limiting the information to be publicly reported to the names of eligible professionals and/or group practices that satisfactorily participate in PQRI and earned the bonus incentive payment, many commenters cited concerns with even listing just the names of participants. Some of the specific concerns cited include:

Lack of program stability;

Lack of evidence demonstrating that compliance with pay- for-reporting programs increases quality;

Lack of evidence to demonstrate the validity of some of the PQRI quality measures;

Successful participation demonstrates only an eligible professional's ability to implement a process and is not a measure of quality;

Publicly reporting PQRI participation information may give beneficiaries or others who visit the Web site the false impression that eligible professionals who participated are practicing higher quality medicine than those who do not participate;

Not clear how information on an individual's participation in the PQRI would be helpful or meaningful;

The analysis of physician performance on some measures will be based on small numbers;

CMS' data on PQRI participation may be an inaccurate representation of the number of eligible professionals participating or making a good faith effort to participate in PQRI since clearinghouses inappropriately removed NPI information from claims submissions;

Major improvements are needed to the Physician and Other

Healthcare Professional Directory before it can form the basis for a

Physician Compare Web site because there are accuracy issues associated with the data on the Physician and Other Healthcare Professional

Directory;

It would be unfair to eligible professionals to publish

PQRI information since no interim feedback reports are provided to help participants determine if they are reporting correctly;

It would be especially unfair to publicly report 2007 and 2008 data because eligible professionals were not informed in advance that such information would be publicly reported;

Publicly reporting 2007 PQRI participation information may be perceived by physicians as reneging on prior commitments that CMS made to physicians in which we indicated that we would not publicly report PQRI information at this time;

While other providers, such as hospitals, home health agencies, and nursing homes had many months of advance notice that CMS would be launching public reporting programs for those provider settings, eligible professionals were given no advance notice that PQRI information would be made public until very recently;

CMS does not have the authority to publicly report PQRI performance information since the Congress only gave CMS the authority to publicly report the names of successful participants;

The PQRI program is too new and is a voluntary program;

Many eligible professionals cannot participate in PQRI due to the lack of applicable measures;

Experience with PQRI is limited and individual eligible professionals are still trying to determine how to integrate PQRI into their office billing processes; and

There are numerous barriers, some of which are described above, that make it difficult for physicians and other eligible professionals to participate in the PQRI.

Response: We are appreciative of the commenters' thoughtful and constructive feedback and will take these concerns into consideration as we further develop our plans for publicly reporting PQRI information. While we understand the commenters' concerns, we note that section 1848(m)(5)(G) of the Act, as added by the MIPPA, requires us to list the names of eligible professionals who satisfactorily submitted

PQRI quality measures data in an easily understandable format on our

Web site. As such, it is our intent to identify the eligible professionals who satisfactorily submit data on quality measures for the 2009 PQRI on the CMS Web site in 2010. We are not required, nor are we specifically authorized by MIPPA or preceding PQRI authorizing legislation, to publicly report 2007 and 2008 PQRI information submitted prior to July 15, 2008.

Comment: A number of the commenters urged CMS to delay the public reporting of information derived from PQRI that was authorized by the

MIPPA because eligible professionals should have the opportunity to view their individual data for several years before it is made public.

Several commenters provided recommendations for CMS to consider with respect to publicly reporting PQRI information and specifically as we proceed with implementing the MIPPA provision to list the names of the individuals or physician groups who successfully participate in the

PQRI on CMS's Web site. Examples of some of the recommendations received include:

CMS should educate the public on PQRI and its limitations and include disclaimer language on the Web site

Page 69846

explaining the PQRI program and its limitations, such as the program is voluntary, there are many barriers to participation and many valid reasons for nonparticipation, there are many factors that could impact participation, the year to year changes to the program, and PQRI participation status is not a proxy for quality.

CMS should conduct a formal evaluation to closely review the 2007 and 2008 PQRI program, including the program's processes and the analysis and validation of the data gathered, before proceeding with public reporting of PQRI participation or performance data. No

PQRI data should be publicly released until its accuracy and reliability is verified, otherwise, serious unintended consequences can occur. CMS must make every effort to ensure the accuracy of any information that will be made public, including demographic information and other information listed in the Physician and Other Healthcare

Professional Directory, and provide the American Medical Association and medical specialty societies access to aggregate PQRI participation data so that these groups can analyze the data to ensure accuracy, improve upon identified quality gaps in specialty care, and work with physicians to boost participation.

The Web site should positively recognize physicians who attempted to participate in the program and if a physician or other eligible professional attempted to participate but was not deemed to be a successful participant, CMS should provide the eligible professionals with the reasons why and give the eligible professional the opportunity to correct any errors, appeal, and/or request that the participant's explanation for why he or she was not successful be made public.

Eligible professionals should also be given the opportunity to publicly explain why they did not participate, including the ability to describe any quality improvement initiatives the eligible professional participates in.

CMS should provide more timely and detailed confidential feedback reports (including interim feedback reports) to providers so that they can quickly address any participation or performance issues before data is posted to the Web site.

Eligible professionals should be notified prior to the start of data collection that data collected in a particular year will be publicly reported and should be given sufficient opportunity to review and comment on any information that will be made public prior to its public release following an initial dry run in which reports are shared only with the eligible professionals. In addition, there should be a formal process to allow eligible professionals to correct any errors. CMS should also make the comments received from the review period public.

CMS should not report the names of those who satisfactorily submitted quality data until the data submission process and the reporting results have been verified.

CMS should work closely with the physician community and other stakeholders in establishing a Physician Compare Web site and should establish a multi-stakeholder workgroup to provide input and feedback to CMS on the development of the Web site, including identifying potential problem areas. This includes conducting focus groups with consumers and providers to determine the goals for public reporting prior to deciding which data to report.

CMS may want to consider reporting data at the physician group or team level as opposed to the individual level as well as consider reporting composite measures rather than individual measures.

Eligible professionals should have the ability to opt-out of having their information made public.

Public reporting of PQRI measurement results should be limited to those measures that have achieved an agreed upon baseline of scientific acceptability post-implementation or to those measures on which eligible professionals chose to submit data.

CMS should publish the names of participating eligible professionals only in cases where the PQRI measures that the eligible professionals reported on has been in use in the PQRI for at least 3 years. This indicates at least some measure of stability in the program and allows CMS to recognize those eligible professionals that reported on measures that have been in use in PQRI for less than 3 years as early adopters.

Any Physician Compare tool developed by CMS needs to be user-friendly and thoroughly vetted and evaluated prior to going live to the public. CMS should consider formats that balance the needs of end users with the amount of data to be displayed and permit specific action by patients, families, and others. The Web site should be designed to report current measure sets but be flexible enough to grow with the addition of measures and physicians over time.

CMS should take a two-phase approach to publicly reporting

PQRI information at the NPI level. In Phase 1 CMS should publicize only the names of those who participated. After 2 years, then CMS should publicize the names of those who participated, those who did not participate and those who participated successfully in Phase 2.

Response: We appreciate the numerous recommendations that were provided in the spirit of ensuring a successful launch of our efforts to make information about physician performance publicly available. As we proceed with making the names of the eligible professionals who satisfactorily report data on quality measures for the 2009 PQRI, we will consider these suggestions along with other input received (both formally and informally) as part of our ongoing dialogue with stakeholders. We believe that many of these suggestions are reasonable and will try to incorporate them into our plans to the extent that they are feasible and practical. c. Plans for Publicly Reporting Information Derived From PQRI

To support the delivery of high-quality, efficient health care and enable consumers and providers to make more informed health care decisions, CMS plans to launch a Physician and Other Health Care

Professional Compare Web site that will enhance the information found on the current Physician and Other Health Care Professionals Directory at http://www.medicare.gov/Physician/Home.asp?bhcp=1. CMS anticipates that the addition of a Physician and Other Health Care Professional

Compare Web site to the compare family of Web sites will complement the quality information CMS already makes available for hospitals, dialysis facilities, nursing homes, and home health facilities. Similar to the other compare Web sites, Physician and Other Health Care Professional

Compare will include information about the quality of care and value for services provided by physicians to Medicare beneficiaries.

As a first step, we plan to use information from the PQRI program to populate a Physician and Other Health Care Professional Compare Web site.

Based on the public comments received and the requirements under section 1848(m)(5)(G) of the Act, we will report publicly the names of eligible professionals that have satisfactorily submitted quality data for the 2009 PQRI. This information will be available in 2010, in an easily understandable format, on a Physician and Other Health Care

Professional Compare Web site at http://www.medicare.gov/Physician/

Home.asp?bhcp=1.

For purposes of publicly reporting the names of eligible professionals, on a Physician and Other Health Care

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Professional Compare Web site, we will post the names of eligible professionals who have (1) submitted data on the 2009 PQRI quality measures through the claims-based reporting mechanism or through registry-based reporting, (2) met one of the satisfactory reporting criteria for the 2009 PQRI described in section II.O1.b above, and (3) received a PQRI incentive payment for covered professional services furnished between January 1, 2009 through December 31, 2009.

As with the other compare Web sites, CMS plans to continue to expand the information that is available on the Physician and Other

Health Care Professional Compare Web site in the future. CMS may publicly report physician information that is maintained in the

``Performance Measurement and Reporting System (PMRS),'' SOR number 09- 70-0584, as amended, in order to improve the quality and efficiency of health care delivery and enable consumers to make more informed health care decisions. This includes posting on an Internet Web site the names of those physicians who report data on quality measures through the

PQRI as described above as well as other types of performance measurement information. More information about the PMRS SOR is available at http://www.cms.hhs.gov/PrivacyActSystemofRecords/ downloads/0584.pdf.

O2. Electronic Prescribing (E-Prescribing) Incentive Program a. Program Background and Statutory Authority

As discussed in section III. of this final rule with comment period, the MIPPA authorizes a new incentive program beginning for 2009 for eligible professionals who are successful electronic prescribers.

Since MIPPA was enacted after publication of the CY 2009 PFS proposed rule, there was no discussion of this new incentive program in the CY 2009 PFS proposed rule. We note, however, that many of the requirements under MIPPA with respect to the new e-prescribing incentive program are self-implementing. In addition, section 1848(m)(5)(C) of the Act, as redesignated and amended by the MIPPA, authorizes us to implement certain aspects of the 2009 e-prescribing incentive program by program instruction or otherwise. Given that the e-prescribing quality measure developed under the PQRI program will be used in 2009, however, we are finalizing the 2009 e-prescribing incentive program in this final rule with comment period.

As defined in Sec. 423.159(a), e-prescribing is the transmission, using electronic media, of prescription or prescription-related information between a prescriber, dispenser, pharmacy benefit manager

(PBM), or health plan, either directly or through an intermediary, including an e-prescribing network. E-prescribing includes, but is not limited to, two-way transmissions between the point of care and the dispenser.

The MMA and the creation of the Medicare Prescription Drug Benefit

Program (Part D) promoted the use of electronic prescribing by requiring the adoption of interoperable Part D standards for electronically prescribing Part D covered drugs prescribed to Part D eligible individuals. As required by section 1860(D)(4)(e) of the Act, as added by the MMA, ``foundation standards'' were adopted on November 7, 2005 (70 FR 67568) and additional Part D e-prescribing standards were adopted on April 1, 2008, that are to become effective April 1, 2009 (73 FR 18918).

Section 1860(D)(4)(e)(6) of the Act, as added by the MMA, also permitted third parties to offset the implementation costs for electronic prescribing by authorizing the creation of an exception to the physician self-referral (``Stark'') prohibition for certain donations of electronic prescribing technology. This enabled health plans, hospitals, and medical groups to provide in-kind support to physicians for electronic prescribing. Furthermore the MMA authorized the creation of a ``safe harbor'' to protect these entities from prosecution under the anti-kickback statute.

There are many potential advantages to e-prescribing. These advantages include, but are not limited, to:

Improving patient safety and quality of care by (reducing medication errors by up to 86 percent):

cir

Reducing illegibility.

cir

Reducing oral miscommunications.

cir

Providing warnings and alert systems.

cir

Providing access to patient's medication history;

Reducing time spent on pharmacy phone calls and faxing;

Automation of renewals and authorization;

Improving formulary adherence (from 14 percent to 88 percent after e-prescribing implementation) (Bell, Douglas S. and

Friedman, Maria A. ``E-Prescribing and the Medicare Modernization Act of 2008.'' Health Affairs. 2005; Volume 24, no.5: 1159-1169); and

Improving drug surveillance/recall;

A more detailed description of the benefits of e-prescribing can be found by clicking on the Clinician's Guide to Electronic Prescribing link at http://www.ehealthinitiative.org/. Many of these advantages were also discussed at a recent e-prescribing conference co-sponsored by CMS. Downloadable information from this conference is available at http://www.e-prescribingconference.com.

Although there are many benefits to electronic prescribing, there has been limited adoption and use of electronic prescribing by physicians and other professionals who prescribe medications. It is estimated that only 5 to 18 percent of providers currently use e- prescribing (Bell, Douglas S. and Friedman, Maria A. ``E-Prescribing and the Medicare Modernization Act of 2008.'' Health Affairs. 2005;

Volume 24, no. 5: 1159-1169.). The enactment of the MIPPA in July, 2008, should encourage significant expansion of the use of electronic prescribing by authorizing a combination of financial incentives and payment differentials. Financial incentives are available for the years 2009 through 2013, and payment differentials apply starting 2012 and for all subsequent years.

Specifically, for 2009, in accordance with section 1848(m)(2) of the Act, as added by section 132(a) of the MIPPA, a ``successful electronic prescriber'' as defined by MIPPA and further discussed below, is eligible to receive an incentive payment equal to 2.0 percent of the total estimated allowed charges submitted not later than 2 months after the end of the reporting period for all covered professional services furnished during the 2009 reporting period. This new E-prescribing Incentive Program is separate from and in addition to any incentive payment that eligible professionals may earn through the

PQRI program discussed above.

Incentive payments for successful electronic prescribers for future years are authorized as follows: 2.0 percent for 2010. 1.0 percent for 2011. 1.0 percent for 2012. 0.5 percent for 2013.

Under section 1848(a)(5) of the Act, as added by section 132(b) of the MIPPA, a PFS payment differential applies beginning in 2012 to those who are not successful electronic prescribers. Specifically, for 2012 and any subsequent year, if the eligible professional is not a successful electronic prescriber for the reporting period for the year, the fee schedule amount for covered professional services furnished by such professionals during the year shall be less than the fee

Page 69848

schedule that would otherwise apply by: 1.0 percent for 2012. 1.5 percent for 2013. 2.0 percent for 2014 and each subsequent years.

The application of the payment differential will be the subject of future notice and comment rulemaking and is beyond the scope of this rule.

Under section 1848(m)(6) of the Act, as amended by the MIPPA, the definition of ``eligible professional'' for purposes of eligibility for the electronic-prescribing incentive program is identical to the definition of ``eligible professional'' for the 2009 PQRI under section 1848(k)(3)(B) of the Act. In other words, eligible professionals include physicians, other practitioners as described in section 1842(b)(18)(C) of the Act, physical and occupational therapists, qualified speech-language pathologists, and beginning in 2009, qualified audiologists. However, eligibility is further restricted by scope of practice to those professionals who have prescribing authority. b. Requirement for Successful Electronic Prescriber

Under section 1848(m)(3)(B) of the Act, as redesignated and added by the MIPPA, in order to qualify for the incentive payment, an eligible professional must be a ``successful electronic prescriber,'' which the Secretary is authorized to identify using one of two possible standards. For 2009, to be a successful electronic prescriber, the standard under section 1848(m)(3)(B)(ii) of the Act will apply, in which an eligible professional must report on at least 50 percent of applicable cases, on such electronic prescribing quality measure(s) established by the Secretary under the PQRI, for use in the Electronic

Prescribing Incentive Program. For 2009, as will be further discussed, there is established one electronic prescribing measure, with the applicable cases being those where particular services are furnished to

Medicare beneficiaries and billed under Part B.

The Secretary also has authority under section 1848(m)(3)(B)(iii) of the Act to identify a substitute standard for successful electronic prescriber based on the electronic prescribing of a sufficient number

(as determined by the Secretary) of Part D prescriptions by an eligible professional for the requirement to report on electronic prescribing measure(s). However, under section 1848(m)(3)(B)(i) of the Act, if this standard were substituted by the Secretary for a particular year, then the standard based on the reporting on electronic prescribing measures would no longer apply or be available. If the Secretary decides to establish the substitute requirement, the Secretary is authorized to use Part D drug claims data to assess whether a sufficient number of prescriptions have been submitted by eligible professionals.

For the 2009 Electronic Prescribing Incentive Program, as described above, we will require eligible professionals to report on the existing electronic prescribing measure established by the Secretary as described in further detail below. In future years, we intend to consider the use of a certain number of Part D prescribing events as the basis for the incentive payment. However, our ability to use this substitute requirement for 2009 is not feasible. Our future consideration will depend on achievement of technical changes that may be necessary and would be addressed in future notice and comment rulemaking. c. The 2009 Reporting Period for Successful Electronic Prescriber

Section 1848(m)(6)(C) of the Act, as redesignated and amended by the MIPPA, defines ``reporting period'' for the 2009 E-Prescribing

Incentive Program to be the entire year. Therefore, like for the 2009

PQRI, the reporting period for the 2009 E-Prescribing Incentive Program is defined as the entire calendar year, or January 1, 2009 through

December 31, 2009. Successful electronic prescribers are eligible to receive an incentive payment equal to 2.0 percent of the total estimated allowed charges submitted by no later than February 28, 2010 for all covered professional services furnished January 1, 2009 through

December 31, 2009. d. 2009 Electronic Prescribing Measure

Section 1848(m)(3)(B)(ii) of the Act provides that a successful electronic prescriber is required to report on each such electronic prescribing measure established under the PQRI and that are applicable to the eligible professional's services. There is one electronic prescribing measure that has been established for the PQRI. This measure was developed in response to the requirement under section 1848(k)(2)(B)(i) of the Act that the Secretary include structural measures for the 2008 PQRI, such as the use of electronic health records (EHRs) and electronic prescribing technology, and again proposed for the 2009 PQRI. The measure is identified as Measure 125 and is included in the 2008 PQRI: ``HIT: Adoption/Use of

Medication E-Prescribing.'' This measure achieved AQA consensus adoption in October 2007, and was included in the 2008 PQRI. The measure was endorsed by the NQF during 2008. The measure is being reported by physicians and other eligible professionals as a quality measure for the 2008 PQRI. As required by section 1848(m)(3)(A) of the

Act, we will finalize Measure 125 in this final rule with comment period (for use in the 2009 E-Prescribing Incentive Program) and then the PQRI will have no electronic prescribing measures for 2009 or thereafter.

We will post the updated measure and its specifications for the 2009 Electronic Prescribing Incentive Program (that is, Measure 125) on or about the date of publication of this final rule with comment period. However, as noted below, we retain the authority to make specification code changes to the electronic prescribing measure until December 31, 2008. Measure specifications and/or reporting instructions for Measure 125 for the 2008 PQRI are not identical to the measure specifications and/or reporting instructions for the 2009 E-Prescribing Incentive Program. The final measure specifications and reporting instructions for the E-Prescribing

Measure 125 for the 2009 E-prescribing incentive program will be posted on the PQRI section of the CMS Web site at http:// www.cms.hhs.gov/PQRI/03_EPrescribingIncentiveProgram.asp#TopOfPage as soon as practical but by no later than December 31, 2008. e. Reporting the Electronic Prescribing Measure

Reporting the electronic prescribing measure for 2009 is limited to claims based submission. The reporting of the measure is subject to the same technical requirements as for PQRI claims based measures in terms of the items that need to be submitted on the claim. Examples of technical requirements include submission of an NPI for the eligible professional, inclusion of the measure reporting codes on the same claim that contains the denominator codes, and no resubmission of the claims for purpose of reporting numerator codes. Detailed information on the technical submission requirements is available on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/pqri.

Measure 125, like other PQRI measures, has two basic elements. These include: (1) A reporting denominator (for Measure 125, this consists of a set of procedure codes) that defines the circumstances when the measure is reportable; and (2) a reporting numerator (for Measure 125, this consists of three specific codes, one of

Page 69849

which must be reported for successful reporting.)

The measure becomes applicable to a particular patient and reportable when, in billing for Part B services, the professional includes at least one of the procedure codes making up the denominator on the claim for payment (for example, a medical visit for CPT code 99213). If one of the denominator codes is included on a claim for Part

B services, then the physician or other eligible professional must report one of the numerator reporting codes on the same claim to meet the reporting requirement. Where the eligible professional fails to report a numerator reporting code specified for the measure on such a claim, then the case would be included in the denominator count, but not in the numerator count for satisfactory reporting. More detailed information on the specific technical requirements for correctly reporting quality data codes is available on the PQRI section of the

CMS Web site at http://www.cms.hhs.gov/pqri. i. Reporting Denominator

The Measure 125 denominator consists of specific billing codes for professional services. They are typically billed for services in the office or outpatient setting furnished by physicians or other eligible professionals. Currently, the denominator codes for the electronic prescribing measure are CPT Codes: 90801, 90802, 90804, 90805, 90806, 90807, 90808, 90809, 92002, 92004, 92012, 92014, 96150, 96151, 96152, 99201, 99202, 99203, 99204, 99205, 99211, 99212, 99213, 99214, 99215, 99241, 99242, 99243, 99244, 99245, and G Codes: G0101,

G0108, G0109. Measure 125 has no diagnosis codes or age/gender requirements in order to be included in the denominator (that is, reporting of the e-prescribing measure is not further limited to certain ages or gender). As previously discussed, for 2009, the measure becomes reportable when any one of these procedure codes is billed by an eligible professional as Part B services. As discussed further under section II.O2.e.iii, however, eligible professionals are not required to report this measure in all cases in which the measure is reportable.

Physicians and other eligible professionals who do not bill for one of these procedure codes on at least one claim during 2009 for Part B services will have no occasion to report the electronic prescribing measure.

There is also a statutory limitation under section 1848(m)(2)(B) of the Act for the E-Prescribing Incentive Program that will be discussed below. For 2009, we are applying the limitation that requires that the total estimated Part B allowed charges for the denominator codes to which the electronic prescribing quality measure (that is, Measure 125) applies must constitute at least 10 percent of the professional's total Part B allowed charges for the incentive to apply.

This limitation is designed to target the electronic prescribing incentive payments to physicians or other eligible professionals who have the opportunity to prescribe a statutorily determined sufficient amount of prescriptions and not provide incentive payments of 2.0 percent of allowed charges in a year to those physicians who do not have the opportunity to prescribe a threshold amount of prescriptions.

However, this limitation does not affect the ability to report the measure, but rather we will apply it in the final determination as to whether an incentive is earned. See the discussion below.

As initially required under section 1848(k)(2)(A)(ii) of the Act, and further established through rulemaking and under section 1848(m)(2)(B) of the Act, we may modify the codes making up the denominator of the electronic prescribing measure. We have considered whether to expand the scope of the denominator codes to professional services outside the professional office and outpatient setting for 2009, such as professional services furnished in hospitals or skilled nursing facilities. Although we retain the authority to update technical specifications of the measure until December 31, 2008 for use in the 2009 E-Prescribing Incentive Program, we will not expand the basic scope of the denominator outside the professional office and outpatient setting.

We believe that several reasons support the limitation of the 2009 e-prescribing measure (that is, Measure 125) denominator codes to physician and other eligible professional office and outpatient settings. First, physicians and other eligible professionals have limited ability to influence the adoption and availability of electronic prescribing systems in hospitals or other provider settings.

Second, including codes for professional services in provider facility settings may negatively impact the ability of professionals who practice in office and facility settings to successfully report the electronic prescribing measure at the required 50 percent of cases.

Without access to electronic prescribing for services furnished in a provider setting, the professional would be unable to report and these cases would count as not reporting if such codes were included in the measure denominator. Third, the effect of the electronic prescribing incentive payment is likely to have its greatest impact in stimulating adoption and use of electronic prescribing in the professional office and outpatient setting. While outpatient services are an imperfect marker, outpatient services are likely to represent the largest opportunity to expand electronic prescribing where prescribing is frequent and the decision to adopt electronic prescribing systems is also dependent on the choices, practices and funding by eligible professionals. Fourth, the statutory limitation that applies to eligibility for the incentive also applies to the future differential payment provisions. Extension of the denominator codes to hospital- based settings of care, may cause professionals who exclusively practice in such settings to be liable for a differential payment for services furnished in a setting where they have limited ability to influence the adoption of electronic prescribing. ii. Qualified Electronic Prescribing System--Required Functionalities and Part D E-Prescribing Standards

To report Measure 125 the eligible professional must report one of three ``G'' codes, as will be discussed below, on the same claim for which one of the denominator codes is billed. In reporting any of the G codes, however, and thereby qualifying for the incentive payment for e-prescribing in 2009, the professional must have and regularly use a ``qualified'' electronic prescribing system as defined in Measure 125. If the professional does not have general access to an e-prescribing system in the practice setting, there is nothing to report. In this way, Measure 125 is more than a ``pay-for-reporting'' measure since the reporting must relate to an already implemented e-prescribing system.

Required Functionalities for a ``Qualified'' Electronic Prescriber

System. What constitutes a ``qualified'' electronic prescribing system is based upon certain required functionalities that the system can perform. As currently specified in Measure 125, a

``qualified'' electronic prescribing system is one that can:

(a) Generate a complete active medication list incorporating electronic data received from applicable pharmacies and PBMs, if available.

(b) Allow eligible professionals to select medications, print prescriptions, electronically transmit prescriptions, and conduct alerts (written or acoustic signals to warn the prescriber of possible undesirable or unsafe

Page 69850

situations including potentially inappropriate dose or route of administration of a drug, drug-drug interactions, allergy concerns, or warnings and cautions).

(c) Provide information related to lower cost, therapeutically appropriate alternatives (if any). The ability of an electronic prescribing system to receive tiered formulary information, if available, would suffice for this requirement for 2009 and until this function is more widely available in the marketplace.

(d) Provide information on formulary or tiered formulary medications, patient eligibility, and authorization requirements received electronically from the patient's drug plan (if available).

Part D E-Prescribing Standards. Section 1848(m)(3)(B)(v) of the

Act, as redesignated and added by the MIPPA, requires that, to the extent practicable, ``the Secretary shall ensure that eligible professionals utilize electronic prescribing systems in compliance with standards established for such systems pursuant to the Part D

Electronic Prescribing Program under section 1860D-4(e) of the Act.''

Part D sponsors must use when they transmit prescriptions and certain prescription related information for Part D covered drugs that are prescribed for Part D eligible individuals. In the qualified electronic prescribing system context of this rule, electronic systems must convey the information listed above under (a) through (d) using the standards currently in effect for the Part D e-prescribing program. New Part D e- prescribing standards will be effective April 1, 2009. These new Part D e-prescribing standards can be found on the CMS Web site at http:// www.cms.hhs.gov/eprescribing.

To ensure that eligible professionals utilize electronic prescribing systems that meet these requirements, E-Prescribing Measure 125 requires that those functionalities required for a

``qualified'' electronic prescribing system must utilize the adopted

Part D e-prescribing standards.

The Part D e-prescribing standards relevant to the four functionalities for a ``qualified'' system in Measure 125, described above and listed as (a), (b), (c), and (d), are:

(a) Generate medication list--Use the National Council for

Prescription Drug Programs (NCPDP) Prescriber/Pharmacist Interface

SCRIPT Standard, Implementation Guide, Version 8, Release 1, October 2005 (hereinafter ``NCPDP SCRIPT 8.1'') Medication History Standard;

(b) Transmit prescriptions electronically--Use the NCPDP SCRIPT 8.1 for the transactions listed at 42 CFR 423.160(b)(2);

Formulary and Benefits Standard, Implementation Guide, Version 1,

Release 0 (Version 1.0), October 2005 (hereinafter ``NCPDP Formulary and Benefits 1.0'');

(d) Provide information on formulary or tiered formulary medications, patient eligibility, and authorization requirements received electronically from the patient's drug plan--use:

(1) NCPDP Formulary and Benefits 1.0

(2) Accredited Standards Committee (ASC) X12N 270/271-Health Care

Eligibility Benefit Inquiry and Response, Version 4010, May 2000,

Washington Publishing Company, 004010X092 and Addenda to Health Care

Eligibility Benefit Inquiry and Response, Version 4010A1, October 2002,

Washington Publishing Company, 004010X092A1 for communicating eligibly information between Medicare Part D sponsors and prescribers.

(4) NCPDP Telecommunication Standard Specification, Version 5,

Release 1 (Version 5.1), September 1999, and equivalent NCPDP Batch

Standard Batch Implementation Guide, Version 1, Release 1 (Version 1.1), January 2000 for communicating eligibility information between

Medicare Part D sponsors and dispensers.

There are, however, Part D e-prescribing standards that are or will shortly be in effect for functionalities that are not commonly utilized at this time. Such functionalities are not currently required for a

``qualified'' system under Measure 125. One example is Rx Fill

Notification, which is discussed in the e-prescribing final rule (73 FR 18918, 18926). For purposes of the 2009 electronic prescribing program and incentive payments, it is not required that the electronic prescribing system contain all functionalities for which there are available Part D e-prescribing standards. Rather, the only required functionalities are those stated in the measure and described above in the section entitled ``Required Functionalities for a `Qualified'

Electronic Prescribing System.'' For those required functionalities described above, a ``qualified'' system must use the adopted Part D e- prescribing standards for electronic messaging. There are other aspects of the functionalities for a ``qualified'' system that are not dependent on electronic messaging and are part of the software of the electronic prescribing system, for which Part D standards for electronic prescribing do not pertain. For example, the requirements in qualification (b) listed above that require the system to allow professionals to select medications, print prescriptions, and conduct alerts are functions included in the particular software, for which

Part D standards for electronic messaging do not apply.

We are aware that there are significant numbers of eligible professionals who are interested in earning the incentive payment, but currently do not have an electronic prescribing system. The electronic prescribing measure does not require the use of any particular system or transmission network, but only that the system be a ``qualified'' system having the functionalities described based on Part D e- prescribing standards. While it is not appropriate for us to suggest particular products, we will post general information at or about the time of publication of this rule that may be helpful to the eligible professional in selecting a system that meets the requirements of a

``qualified'' system under Measure 125. Additionally, we will provide additional clarifying information, as needed, in the form of

Frequently Asked Questions (FAQs) and post them on the CMS Web site. iii. Reporting Numerator

To report for an applicable case where one of the denominator codes is billed on a claim for Part B services, an eligible professional must submit one of three G codes specified in Measure 125 on the same Medicare Part B claim.

One G code is used to report that all prescriptions in connection with the visit billed were electronically prescribed;

Another G code indicates that no prescriptions were generated during the visit; and

A third G code is used when some or all prescriptions were written or phoned in due to patient request, State or Federal law, the pharmacy's system being unable to receive the data electronically or because the prescription was for a narcotic or other controlled substance.

As we have previously discussed, to qualify for an incentive payment under the electronic prescribing incentive program, the eligible professional must report applicable G codes on claims containing one or more denominator billing codes, in at least 50 percent of applicable cases. Since the measure does not apply to claims for services not containing one of the denominator codes, professionals need not report G codes for the electronic prescribing measure on claims not containing one of the denominator codes.

Page 69851

Although only one of the three reportable G codes indicates that the physician or eligible professional used electronic prescribing for all of the prescriptions provided during the encounter, the reporting of any one of the G codes counts as successful reporting and toward the required 50 percent reporting requirement. However, as previously discussed by reporting any one of the G codes, the physician or eligible professional is indicating that an electronic prescribing system has been adopted for use.

With respect to narcotics and controlled substances, the third G code is reported in connection with using written prescriptions rather than electronic prescribing for such medications, because electronic prescribing of these medications is currently prohibited by Federal regulation. We are aware that the Drug Enforcement Agency (DEA) has proposed regulatory changes which if finalized would allow electronic prescribing of controlled substances under certain circumstances. This third G code would continue to be reportable for the 2009 Electronic

Prescribing Measure without regard to possible changes in the DEA's regulations with respect to the electronic prescribing of controlled substances. Based on concerns expressed to us, we are aware that professionals may find it impractical to utilize electronic prescribing for controlled substances, depending on specific requirements that may be finalized by the DEA. Therefore, to alleviate uncertainty with respect to the electronic prescribing incentive program, for 2009, physicians and other eligible professionals may report the electronic prescribing measure without any requirement to use electronic prescribing for narcotics or other controlled substances without regard to final action that the DEA may take on this subject, based on the G codes contained in the Electronic Prescribing Measure. f. Determination of Successful Electronic Prescriber and Amount of

Incentive Payment

Determination of professionals who are Successful Electronic

Prescribers for 2009 is at the individual professional level, based on the National Provider Identifier (NPI) as it is under PQRI. However, payment is made to the practice represented by the Tax Identification

Number (TIN) to which payments are made for the individual professional's services. Inasmuch as some individuals (NPIs) may be associated with more than one practice or TIN, determination of

Successful Electronic Prescriber for 2009, as it is for PQRI, will be made for each unique NPI-TIN combination. Payment will be made to the applicable TIN.

Under PQRI, a physician or other eligible professional may meet, in theory, the criteria for satisfactory reporting on as few as a single patient falling within the denominator of a measure and correctly reporting on that measure. In the case of the E-Prescribing Incentive

Program, however, section 1848(m)(2)(B) of the Act, as added by the

MIPPA, imposes a limitation. As discussed above, for 2009, the limitation provides that the electronic prescribing incentive is not available to an eligible professional unless the eligible professional's total estimated allowed charges for covered Medicare

Part B services furnished for the codes in the denominator of the 2009

Electronic Prescribing Measure make up at least 10 percent of the eligible professional's total allowed charges for all covered Medicare

Part B professional services furnished by the eligible professional during the 2009 reporting period (that is, January 1, 2009 through

December 31, 2009). The statutory limitation also applies to the future application of the payment differential, which limits those to whom the differential will apply as well.

Therefore, in determining whether an eligible professional will receive an electronic prescribing incentive payment, CMS will determine whether the 10 percent threshold is met based on the claims submitted by the eligible professional at the NPI/TIN level. This calculation is expected to take place in the first quarter of 2010 and will be performed by dividing the individual's total 2009 charges submitted for the measure's HCPCS codes by the individual's total Medicare Part B charges (as assessed at the NPI/TIN level). If the result is 10 percent or more, then the statutory limitation does not apply and a successful electronic prescriber would earn the electronic prescribing incentive payment. If the result were less than 10 percent, then the statutory limitation would apply and the eligible professional could not receive an electronic prescribing incentive payment.

As discussed previously, this limitation will be applied by CMS in determining whether the individual professional meets the requirements for the incentive payment. Although individual eligible professionals may decide about whether to report based on their own assessment of what portion of their allowed charges for Part B services are likely to be made up of services represented by the denominator codes, individual professionals may report the numerator codes without regard to the statutory limitation for the incentive payment.

If an eligible professional meets the 10 percent threshold for 2009, we will determine whether the professional is a successful electronic prescriber by reporting the numerator codes for 50 percent of applicable cases. If the professional is determined to be a successful electronic prescriber, then the incentive payment will be made.

As indicated above, for 2009, the electronic prescribing incentive payment is 2.0 percent of the total estimated Part B allowed charges for the reporting period (that is, the entire year, for 2009). Thus, the incentive payment is not solely 2.0 percent of the estimated Part B allowed charges for services for which the measure is reported, but 2.0 percent of all estimated Part B allowed charges for the year. In other words, although the measure denominator is limited to certain office and outpatient professional services, and the requirement to be an electronic prescriber is based on those services, the incentive payment is paid as 2.0 percent of all estimated Part B allowed charges for the professional, submitted by the end of February 2010. g. Uses of Information on Successful Electronic Prescribers

As discussed in section II.O1.e.i. above, section 1848(m)(5)(G) of the Act, as added by the MIPPA and described in section III. of this final rule with comment period, requires the Secretary to post on the

CMS Web site, in an easily understandable format, a list of the names of eligible professionals (or group practices) who satisfactorily submitted data on quality measures for the PQRI and the names of the eligible professionals (or group practices) who are successful electronic prescribers. As noted previously, this requirement cannot be applied retrospectively to data that was collected prior to the enactment of the MIPPA.

In order to implement this requirement we will report publicly the names of eligible professionals who are successful electronic prescribers for the 2009 E-Prescribing Incentive Program. Along with the names of eligible professionals who satisfactorily submitted data on quality measures for the 2009 PQRI, the names of eligible professionals who are successful electronic prescribers will be available in 2010, in an easily understandable format, on a Physician and Other Health Care Professional Compare Web site at http:// www.medicare.gov/Physician/Home.asp?bhcp=1.

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Accordingly, we will post on the CMS Web site the names of eligible professionals (1) whose 2009 Medicare Part B charges for codes in the denominator of the E-Prescribing Measure 125 make up at least 10 percent of the eligible professional's Medicare Part B charges for 2009; (2) who reported the E-Prescribing Measure 125 in at least 50 percent of the cases in which the measure was reportable during 2009; and (3) who received an e-prescribing incentive payment for covered professional services furnished January 1, 2009 through

December 31, 2009.

Since the PQRI and the E-Prescribing Incentive Program are two separate incentive programs, it is feasible for an eligible professional who participated in both incentive programs to be listed both as an individual eligible professional who satisfactorily submitted data on quality measures for the PQRI and a successful electronic prescriber if he or she met the criteria for both incentive programs. d. Summary of Comments and Responses

Although the MIPPA was not enacted until after publication of the

CY 2009 PFS proposed rule, we received some comments related to this new incentive program that was authorized by the MIPPA. A summary of these comments and our responses is below.

Comment: We received a few comments about the PQRI Measure 125. These commenters suggested that prior to implementation of this quality measure in the e-prescribing incentive program, the quality measure and our design of the e-prescribing incentive program should go through a public comment process. One commenter indicated support for the e-prescribing incentive but noted that implementing e- prescribing in physicians' offices is resource intensive and many local pharmacies are not prepared to use e-prescribing.

Response: As described above, the MIPPA requires us to implement an incentive payment for successful electronic prescribers beginning in 2009. Many of the MIPPA requirements with respect to the incentive payment for successful electronic prescribers are generally self- implementing, require little exercise of discretion, and build on existing aspects of the PQRI that have already been proposed. In addition, although section 1848(m)(5)(C) of the Act, as redesignated and amended by the MIPPA, authorizes us to implement certain aspects of the 2009 e-prescribing incentive program by program instruction or otherwise, we are finalizing this program for 2009 in this final rule with comment period. The quality measure that we are using to determine whether an eligible professional qualifies as a successful electronic prescriber was available for public comment during its development by

QIP as well as during the consensus process for AQA adoption and NQF endorsement, both of which have been achieved. Additionally, as this quality measure was one of the quality measures proposed for the 2009

PQRI in the CY 2009 PFS proposed rule, the public had an opportunity to comment on this quality measure during the proposed rule's comment period.

Comment: One commenter was concerned that future DEA regulation changes may complicate e-prescribing. The commenter urged us to exempt e-prescribing of controlled substances from any assessment of differential payments.

Response: We are aware of the proposed DEA regulation changes and believe the modification and explanation of the third G code described above adequately addresses this issue.

Comment: We received one comment that emergency department evaluation and management codes do not appear in the denominator of the e-prescribing measure proposed for the 2009 PQRI (Measure 125). Another commenter suggested that we maintain the eye visit codes in this measure so that ophthalmologists can participate in the e-prescribing incentive program.

Response: We have addressed in the body of the preamble the comment with respect to hospital based services of professionals. The current measure specifications contain office and outpatient codes applying to eye care. As stated above, we will post the final specifications for the e-prescribing measure for purposes of the 2009 e-prescribing incentive program no later than December 31, 2008.

Comment: A few commenters objected to the fact that there is no definition as to what constitutes an acceptable hardship exemption for the e-prescribing incentive initiative.

Response: As discussed briefly above, section 1848(a)(5)(A) of the

Act, as added by the MIPPA, authorizes the Secretary, starting in 2012, to apply a differential fee schedule amount for covered professional services furnished by an eligible professional who is not a successful electronic prescriber. In accordance with section 1848(a)(5)(B) of the

Act, the Secretary may, on a case-by-case basis, exempt an eligible professional from the application of the payment differential if the

Secretary ``determines, subject to annual renewal, that compliance with the requirement for being a successful electronic prescriber would result in a significant hardship.'' This hardship exemption is to be used at the discretion of the Secretary.

Since this hardship exemption pertains only to those eligible professionals subject to a payment differential because they did not meet the criteria for becoming a successful electronic prescriber, this provision will not become effective until 2012 when the payment differential for those eligible professionals who are not successful electronic prescribers is first required. As such, the definition of what constitutes an acceptable hardship is beyond the scope of this final rule with comment period.

P. Discussion of Chiropractic Services Demonstration

In the CY 2006, CY 2007, and CY 2008 PFS final rules with comment period (70 FR 70266, 71 FR 69707, 72 FR 66325, respectively), we included a discussion of the 2-year chiropractic services demonstration that ended on March 31, 2007. This demonstration was required by section 651 of the MMA to evaluate the feasibility and advisability of covering chiropractic services under Medicare. These services extended beyond the current coverage for manipulation to care for neuromusculoskeletal conditions typical among eligible beneficiaries, and covered diagnostic and other services that a chiropractor was legally authorized to perform by the State or jurisdiction in which the treatment was provided. The demonstration was conducted in four sites, two rural and two urban. The demonstration was required to be budget neutral as the statute requires the Secretary to ensure that the aggregate payment made under the Medicare program does not exceed the amount which would be paid in the absence of the demonstration.

Ensuring BN requires that the Secretary develop a strategy for recouping funds should the demonstration result in costs higher than those that would occur in the absence of the demonstration. As we stated in the CY 2006 and CY 2007 PFS final rules with comment period, we would make adjustments to the chiropractor fees under the Medicare

PFS to recover aggregate payments under the demonstration in excess of the amount estimated to yield BN. We will assess BN by determining the change in costs based on a pre- and post-comparison of aggregate payments and the rate of change for specific

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diagnoses that were treated by chiropractors and physicians in the demonstration sites and control sites. Because the aggregate payments under the expanded chiropractor services may have an impact on other

Medicare expenditures, we will not limit our analysis to reviewing only chiropractor claims.

Any needed reduction to chiropractor fees under the PFS would be made in the CY 2010 and CY 2011 physician fee schedules as it will take approximately 2 years after the demonstration ends to complete the claims analysis. If we determine that the adjustment for BN is greater than 2 percent of spending for the chiropractor fee schedule codes

(comprised of the 3 currently covered CPT codes 98940, 98941, and 98942), we would implement the adjustment over a 2-year period.

However, if the adjustment is less than 2 percent of spending under the chiropractor fee schedule codes, we would implement the adjustment over a 1-year period. We intend to provide a detailed analysis of BN and the proposed offset during the CY 2010 PFS rulemaking process.

The following is a summary of the public comments we received and our responses.

Comment: We received one comment concerning the methodology for determining BN. The commenter stated that the Congressional intent for implementing BN is clearly spelled out in section 651(f)(1)(A) of the

MMA. The commenter believes the demonstration's costs should be offset from the totality of services payable under the Part B Trust Fund, and not a discrete minority of services. The commenter stated that our methodology is flawed because it offsets demonstration costs only from existing chiropractic services.

Response: Section 651(f)(1)(A) of the MMA requires that ``* * * the

Secretary shall ensure that the aggregate payment made by the Secretary under the Medicare program do not exceed the amount which the Secretary would have paid under the Medicare program if the demonstration projects under this section were not implemented.'' The statute does not specify a specific methodology for ensuring BN. Our methodology meets the statutory requirement for BN and appropriately impacts the chiropractic profession that is directly affected by the demonstration.

The BN adjustment under PFS will be limited to adjusting the chiropractor fee schedule codes (comprised of the 3 currently covered

CPT codes: 98940, 98941, and 98942). No other codes would be affected.

Q. Educational Requirements for Nurse Practitioners and Clinical Nurse

Specialists

In the CY 2009 PFS proposed rule (73 FR 38576), we proposed a technical correction to the nurse practitioner (NP) qualifications at

Sec. 410.75(b) to require that, in order for NP services furnished by an individual to be covered by Medicare, a NP who obtains Medicare billing privileges as a NP for the first time on or after January 1, 2003, must meet all of the following criteria: (1) Be a registered professional nurse who is authorized by State law to practice as a NP;

(2) be nationally certified as a NP; and (3) have a master's degree in nursing. The current NP qualification standards in our regulations include progressive requirements that are not entirely date specific.

The absence of a date specification for each of the qualification standards could allow nurses who have never been enrolled under

Medicare and obtained Medicare billing privileges as a NP an opportunity to enroll as a NP after January 1, 2003, without a master's degree in nursing. Such an enrollment would be contrary to our policy, as explained further below.

We discussed the NP qualifications and our intent to move progressively toward requiring a master's degree in nursing as the standard for all new NPs enrolling and participating under the Medicare

Part B benefit in the CY 2000 PFS proposed rule (64 FR 39625) and the subsequent final rule (64 FR 59411). In the CY 2000 PFS final rule, we stated, ``the requirement that a NP applying for a Medicare billing number for the first time must have a master's degree in nursing as of

January 1, 2003, will provide NPs without a master's degree with enough time to earn such a degree. We believe it is reasonable to require ultimately, a master's degree as the minimum educational level for new practitioners independently treating beneficiaries and directly billing the Medicare program.''

In the CY 2009 PFS proposed rule (73 FR 38576), we also proposed to amend our regulations at Sec. 410.75(b)(4) which require that NPs must have a master's degree in nursing. We proposed to also recognize a

Doctor of Nursing Practice (DNP) doctoral degree (which can be obtained without a master's degree in nursing). In addition, we proposed to amend a similar qualification standard for clinical nurse specialists

(CNSs) at Sec. 410.76(b)(2) that requires advanced practice nurses

(APNs) to have a master's degree in a defined clinical area of nursing from an accredited educational institution in order to allow CNSs, alternatively, to meet these requirements with a DNP doctoral degree.

In the proposed rule, we acknowledged that we are aware that some educational institutions are offering programs to prospective NPs and

CNSs that allow students to move from a baccalaureate degree in nursing directly to the doctoral degree in nursing where they earn a DNP as a terminal clinical doctoral degree. Therefore, some APNs who earn the

DNP degree do not receive a master's degree in nursing even though they will have met all of the educational requirements for a master's degree in nursing, in addition to the preparation that merits them the DNP degree. We noted that a Wall Street Journal article (published April 2, 2008) stated that by the year 2015, the American Association of

Colleges of Nursing aims to make the doctoral degree the standard for all new APNs. We believe that it is logical for Medicare to recognize

APNs with more extensive education and training. Therefore, we proposed to permit qualified APNs with the DNP degree to enroll and receive

Medicare Part B payment as NPs and CNSs.

We received several comments on our proposals with the majority from national organizations. The following is a summary of the comments received and our responses.

Comment: All of the comments that we received on our proposed technical correction supported the change. The commenters agreed that the intent of the graduated NP educational qualifications was to ensure that practicing NPs and their patients were not left unable to enroll in Medicare after we adopted our rules requiring national certification and a master's degree in nursing for enrollment. Many commenters stated that these NPs had already been recognized and practicing as Part B suppliers. The commenters also stated that the technical correction does not appear to violate the intent of the NP educational qualifications and should reduce any confusion that might still remain regarding this requirement.

Response: We are finalizing the technical correction as proposed in order to clarify our requirement that effective on or after January 1, 2003, all NPs must have a master's degree in nursing.

Comment: The majority of commenters commended CMS for our proposal to recognize the DNP degree and stated that we are keeping pace with the transformation in advanced practice registered nursing education.

The commenters applaud CMS for recognizing the DNP degree as a valid

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degree that exceeds a master's degree in nursing and stated that recognition of the DNP degree will be positive for patients.

However, some commenters cautioned against eliminating the master's degree in nursing for NPs and CNSs and replacing it with the DNP degree only. The commenters stated that transitioning to the DNP degree as the national standard by 2015 is only a goal toward which the nursing profession will work and that it may take longer for some programs than others to address State licensing and institutional issues.

Accordingly, the commenters requested that both the master's degree in nursing and the DNP degree must be recognized by CMS as appropriate credentials for APN reimbursement. Additionally, one commenter urged

CMS not to require a master's of science in nursing (MSN) degree instead of a master's degree in nursing.

Response: As we stated in the CY 2009 PFS proposed rule, we believe that it is logical for Medicare to recognize APNs with more extensive education and experience while continuing to recognize NPs and CNSs with a master's degree in nursing. NPs or CNSs with a doctoral degree in nursing practice should not be denied enrollment in the Medicare program because our educational standard for NPs and CNSs is a master's degree. Additionally, we do not intend to eliminate the master's degree in nursing requirement and replace it with solely the DNP degree. We also have no plans to require a MSN degree in lieu of a master's degree in nursing.

Comment: Two commenters stated that they have not yet taken a position on the DNP degree and on the various DNP programs that graduate APNs. However, the commenters noted that many schools offering the DNP degree have programs that focus on areas other than clinical practice such as administration, leadership, business, and nursing policy. The commenters also stated that DNP graduates seeking to enroll in Medicare as new suppliers should hold a clinically-based DNP degree and also, ideally, attain advanced practice certification. The commenters believe that NPs and CNSs who graduate from DNP programs should not be allowed to bypass the master's degree in nursing before achieving the DNP degree because they believe that the master's education provides the appropriate foundation for CNS practice. One commenter is opposed to Medicare's recognition of the DNP degree in

Medicare regulations at this time because of the varying routes of entry into a DNP program have not been resolved, there is a lack of standardization of DNP programs' multiple accreditation processes. The commenters also stated that, and Federal recognition of an unproven nursing doctoral program seems premature given that no State licensing agency or State board of nursing has developed statutes or regulations authorizing the utilization of the DNP as a substitute for the master's education requirement and NP or CNS certification.

Response: We believe that as any new educational program develops, there are likely to be some uncertainty and inconsistency inherent in the process. However, the APN community has a stated goal of moving toward a national standard of graduating APNs from DNP programs. We do not believe that it is sensible to deny Medicare enrollment to a registered professional nurse with a DNP degree who meets all of the other qualification requirements when we enroll nurses with a master's degree. We have relied on our contractors to enroll only those NPs and

CNSs who have graduated with a master's degree in nursing in addition to meeting other qualification standards that require State licensure and certification by a recognized national certifying body. We believe that these collective qualifications ensure that only qualified nurses with proper clinical training furnish services to Medicare patients.

However, we plan to study and monitor DNP programs as they continue to evolve. If we discover that APNs enrolling in Medicare as graduates of

DNP programs are not sufficiently qualified to furnish services to

Medicare patients, we will reconsider our education requirements and take appropriate action.

Comment: One commenter suggested revising the definition of a physician under the NP and CNS qualifications.

Response: We believe this comment is outside the scope of this regulation, and therefore, we are not addressing this comment at this time.

After reviewing the public comments, we are finalizing our proposals to amend the NP qualifications to incorporate the technical correction and to include the DNP degree under the educational qualification requirements for NPs and CNSs. However, we will continue to study and monitor DNP nursing programs, State legislative action, and the State boards of nursing as the DNP degree evolves.

R. Portable X-Ray Issue

The Conditions for Coverage (CfC) for Portable X-Ray services are authorized by section 1861(s)(3) of the Act and were adopted in January 1969. These requirements have, for the most part, been subjected to minimal modification over the years.

The current requirements in our regulations at Sec. 486.104

(Qualifications, orientation, and health of technical personnel) are inconsistent with existing professional standards of practice and training requirements. Specifically, the current qualification requirements for x-ray personnel in Sec. 486.104(a)(1), (a)(2), and

(a)(3) rely on credentialing activities from the Council on Education of the American Medical Association (CEAMA) and the American

Osteopathic Association (AOA) which no longer approve formal training programs for x-ray technology and have not done so since 1992.

Beginning in 1976, the Joint Review Committee on Education in

Radiologic Technology (JRCERT) worked in collaboration with the

Committee on Allied Health Education and Accreditation (CAHEA) of the

American Medical Association (AMA) to accredit programs. However, the

CAHEA was dissolved by the AMA in 1992 and JRCERT subsequently sought approval from the United States Department of Education (USDE) to approve and accredit x-ray technology programs. Approval was granted to

JRCERT by the USDE in 1992. JRCERT is now the only accrediting entity recognized by the USDE that approves these programs; however, JCERT is not a recognized accrediting body under the current regulation at Sec. 486.104.

Before an x-ray technology program can be approved by JRCERT, the

American Society of Radiologic Technologists (ASRT) must approve the program's curriculum. Prior to 1992, the curriculum for x-ray technology programs was based on 24 months, which is reflected in the current regulations at Sec. 486.104. ASRT no longer bases its evaluation on program duration, but rather on program requirements.

Thus, a program could be less than 24 months in duration and still be eligible for JRCERT approval and accreditation if its curriculum was

ASRT approved. Because Sec. 486.104(a)(1) reflects the outdated 24- month standard, some x-ray technicians who actually meet community standards for education and training do not meet Medicare standards as they stand.

Since the current Medicare requirements in Sec. 486.104(a)(1) are outdated, referencing organizations that no longer perform the stated function and requiring a specific duration of training that is no longer the community standard, we proposed to revise the regulation to reflect the current

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requirements. References to schools approved by the CEAMA or the AOA will be deleted, and approval by JRCERT will be added. In addition, we proposed that the requirement for formal training of not less than 24 months in duration be deleted, since this criterion has not been part of the criteria established by entities that evaluate and approve x-ray technology programs since 1993.

We proposed to retain the 24-month criterion in Sec. 486.104(a)(2) and (a)(3) (affecting persons obtaining training prior to July 1, 1966) as program duration was one determinant of program quality at that time. To address those who completed their training after July 1, 1966 but before January 1, 1993, the time period during which CEAMA and the

AOA were approving training programs, we proposed the addition of a new paragraph Sec. 486.104(a)(4) to this section. This addition will reflect the standards for credentialing activities during this time frame.

The following is a summary of the comments we received and our responses.

Comment: Commenters suggested an alternate requirement for qualification as an x-ray technologist, namely American Registry of

Radiologic Technologists (ARRT) certification. The commenters also stated that restricting recognition to only graduates of JRCERT accredited educational programs could create a shortage of radiographers eligible to furnish procedures.

Response: We agree that certification by the ARRT is widely recognized; however, ARRT certification is voluntary, and therefore, may not be required as a condition of employment. Requiring ARRT certification would present an additional expense and testing obligation that individuals who are otherwise qualified might not choose to incur. Such a requirement would also make it necessary for those who are already working in the field to obtain ARRT certification if they are not already certified.

The goal of our proposed revision was to update our regulations to reflect the accurate accrediting entity and program requirements for x- ray technology programs. As it stood, the regulation was inaccurate by referencing organizations that no longer approve and accredit x-ray technology programs, and by specifying an outdated 24-month program requirement. It was not our intention to consider imposing new or additional qualification requirements for technicians.

In accordance with existing regulations, we will continue to recognize as qualified those individuals who have successfully completed a program of formal training in x-ray technology in a school approved by the JRCERT, as well as those who have earned a bachelor's or associate degree in radiologic technology from an accredited college or university. States will continue to have the autonomy to utilize the

ARRT exam for State licensing purposes.

After reviewing the public comments, we are finalizing the provisions as proposed.

S. Other Issues 1. Physician Certification (G0180) and Recertification (G0179) for

Medicare-Covered Home Health Services Under a Home Health Plan of Care

(POC) in the Home Health Prospective Payment System (HH PPS)

In the CY 2009 PFS proposed rule (73 FR 38578), we solicited public comments on policy options regarding physician involvement in the certification and recertification for Medicare-covered home health services under a home health plans of care (POC), payment for those services, and the basis for those payments (relative resources measured in RVUs). Currently, we pay physicians for both the certification and recertification of home health POCs under HCPCS codes G0180 and G01779, respectively. We make payment for these services through the PFS.

In the CY 2009 PFS proposed rule, we expressed our concern that physician involvement in the home health POC may not be as extensive as we had hoped. We recognize that there exists a vast array of differing levels of physician involvement in the certification and recertification of home health POCs. We continue to believe that the active involvement of the physician (to include ``in-person'' contact with the patient) in the certification, recertification, and review of the home health POC is essential for delivery of high quality home health services to Medicare beneficiaries.

To that end, we offered different policy options and solicited the public for comment on those options in an effort to gather more information on this issue, and any other possible underlying issues that may exist.

The following is a summary of the comments and our response.

Comment: Most commenters suggested that we leave our current policies and payment to physicians unchanged, at least until the further analysis is completed. To that end, it was suggested by commenters that we continue to study the role of the physician in home care and determine which factors enhance a physician's ability to conduct oversight activities, ensure appropriateness of care, and work collaboratively with home health agencies without further burdening

Medicare beneficiaries. Commenters urged CMS to engage with industry organizations that represent the physicians that furnish these services, to determine goals and assess options. Commenters further suggested that goals and options could include revising the procedure codes used for billing, assessing the current RVUs, and establishing documentation expectations.

Some commenters suggested that payments to physicians for certifying and recertifying HH POCs should be restructured to provide incentives for greater physician involvement, to include personally seeing the patients. Specifically, some commenters suggested adding different payments for the varying levels of physician involvement in the certification and recertification of HH POCs. Other commenters urged CMS to consider how home telehealth can be employed to a greater degree to increase input of clinical information directly to physicians in lieu of face-to-face contact.

Other commenters suggested that we actively support amending the

Medicare statute to allow nurse practitioners (NPs) to certify and recertify HH POCs. Some commenters suggested that we actively support demonstrations and legislative proposals to build on the concept of merging home care with primary care under a single care management entity for persons in the advanced stages of chronic illnesses. Other commenters suggested that payment to medical directors should be restored to HHAs, along with requirements for their education and a definition of their role, and that we consider reimbursement for a planning teleconference between the physician and home health personnel.

Response: We appreciate the comments from the public on this matter and will continue to analyze and consider those comments and suggestions in future rulemaking. 2. Prohibition Concerning Payment of Continuous Positive Airway

Pressure (CPAP) Devices a. Background

Obstructive Sleep Apnea (OSA, sometimes referred to as Obstructive

Sleep Apnea Hypopnea Syndrome-OSAHS) is associated with significant morbidity and mortality. It is a

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commonly under-diagnosed condition that occurs in 4 percent of men and 2 percent of women. The prevalence increases with age (up to 10 percent in persons 65 and older), as well as with increased weight.

Complications of OSA include excessive daytime sleepiness, concentration difficulty, coronary artery disease, and stroke. It is estimated that 10 percent of patients with congestive heart failure

(CHF) have OSA, which is independently associated with systemic arterial hypertension. Also, untreated OSA is associated with a ten- fold increased risk of motor vehicle accidents.

Continuous Positive Airway Pressure (CPAP) is prescribed by physicians to treat OSA. The patient wears a face mask that provides air pressure to help keep the breathing passages open during sleep. The purpose is to prevent the collapse of the oropharyngeal walls and thereby prevent the obstruction to airflow during sleep, which occurs in OSA. This treatment is generally continued for the rest of the patient's life.

In 2006, Medicare spent approximately $750 million for the diagnosis and treatment of OSA. Sixty five percent of those expenditures represent the amount Medicare spent on diagnostic related costs of OSA using attended facility-based polysomnography (PSG). The remaining $260 million represents the amount spent on treatment related costs associated with the CPAP.

Stakeholders in the sleep community suggest that OSA is currently underdiagnosed and that the numbers of persons using of CPAP will rapidly grow with greater public awareness and the convenient availability of in home testing. It is difficult to precisely estimate the ultimate growth because the true proportion of undiagnosed beneficiaries is unknown, and the current stakeholder estimates may reflect the prior limited access to home sleep testing in the Medicare population. We expect that this combined with the March 2008 expansion of CPAP coverage may lead to significantly increased overall Medicare payments related to OSA diagnosis and CPAP treatment. Though we believe that most of this increase will likely arise from greater beneficiary access to medically appropriate care, we are concerned that even a limited proportion of fraud and abuse will be a significant vulnerability when applied in a very large benefit.

On March 13, 2008, we published a national coverage determination

(NCD) that extends coverage of CPAP devices to beneficiaries whose OSA has been diagnosed by certain unattended sleep tests furnished in a setting other than a sleep laboratory facility, that is, tests that are furnished in the beneficiary's home, commonly referred to as home sleep tests (HSTs). Prior Medicare policy had covered CPAP devices only for beneficiaries who's OSA had been diagnosed by facility-based attended

PSG. Attended facility-based PSG is a comprehensive diagnostic sleep test including at least electroencephalography, electro-oculography, electromyography, heart rate or electrocardiography, airflow, breathing effort, and arterial oxygen saturation furnished in a sleep laboratory facility in which a technologist supervises the recording during sleep time and has the ability to intervene if needed.

The NCD represents a significant expansion of coverage and facilitates the new participation of new entities that had not previously been involved in the provision of this benefit. This also allows testing to occur in patient homes, which are not regulated as health care facilities. For these and additional reasons we describe below, we believe that the diagnosis of OSA for coverage of CPAP merits proactive and ongoing oversight by CMS. Therefore, we intend to closely monitor this benefit.

During the NCD public comment period, we received many comments expressing concern that financial incentives could lead to abusive testing practices that may harm Medicare beneficiaries and the Medicare program. Though these concerns were largely focused on vulnerability that might accompany the entry of new types of entities into the sleep test business following a broad expansion of coverage, some commenters suggested that vulnerabilities would be found in sleep test facilities.

Therefore, in the CY 2009 PFS proposed rule, we proposed to prohibit the provider of a qualifying sleep test--both PSG and HST--from also being the supplier of the CPAP device. Our use of the term provider throughout this rule refers to those individuals or entities that administer and/or interpret the sleep test and/or furnish the sleep test device, as described below. The provision of diagnostic sleep testing includes TCs and PCs related to the administration and interpretation of the test itself. Commonly one entity will furnish the sleep test device and another entity, such as a physician, will furnish the professional interpretation of the result generated by the device.

Depending on the location in which the test is performed (that is, attended facility-based PSG or a HST), a sleep test provider may furnish the sleep test in its own physical facility, that is, the sleep laboratory, or may furnish the sleep test device and deliver it to and retrieve it from the beneficiary's home.

We believe that Medicare beneficiaries and the Medicare program are vulnerable if the provider of a diagnostic test has a financial interest in the outcome of the test itself. This creates incentive to test more frequently or less frequently than is medically necessary and to interpret a test result with a bias that favors self-interest. In the specific context of this rule, we believe that the provider of a sleep test has self-interest in the result of that test if that provider is affiliated with the supplier of the CPAP device that would be covered by the Medicare program. We believe that in most cases the provider that would be submitting a claim for payment related to the sleep test will not be the beneficiary's primary physician but will be another party, for example, another physician or a diagnostic testing entity. We note that only rarely would a Medicare participating physician also be enrolled as a Medicare DME supplier. b. Regulation

In the CY 2009 PFS proposed rule, we proposed to prohibit DME supplier payment for a CPAP device if the provider of a sleep test that is used to diagnose obstructive sleep apnea (OSA) in the Medicare beneficiary is the DME supplier or an affiliate of the supplier of the

CPAP machine used to treat the beneficiary's sleep apnea. The proposal applied to all sleep testing from attended facility-based PSG to unattended HST.

Based on section 1871(a)(1) of the Act, which provides the

Secretary with the authority to ``prescribe such regulations as may be necessary to carry out the administration of the insurance programs under this title,'' and section 1834(j)(1)(B)(ii)(IV), which requires suppliers of equipment and supplies to ``meet such other requirements as the Secretary may specify,'' and due to our concerns with respect to the potential for unnecessary utilization of sleep tests, we shall prohibit payment to the supplier of the CPAP device when such supplier, or its affiliate defined as a person or organization that is related to another person or organization through a compensation arrangement or some type of ownership, is directly or indirectly the provider or the interpreter of the unattended out of facility sleep test that is used to diagnose a Medicare beneficiary with OSA.

We considered several options. We considered whether a narrower

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prohibition could reasonably accomplish the purposes of this regulation at this time. Exceptions for providers that offer integrated disease management models were considered. We also considered allowing an exception for nationally accredited disease management programs but we are unaware of any current model that was encompass accreditation for both OSA diagnosis and CPAP supply under a single accreditation certificate.

Therefore, we proposed to revise the durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) supplier enrollment safeguards set forth at Sec. 424.57 to protect the Medicare program and its beneficiaries from fraudulent or abusive practices that may be related to CPAP devices. We also proposed to add new definitions to paragraph (a) to define ``Continuous positive airway pressure (CPAP)'' and ``sleep test'' and to add a new paragraph (f), which would establish a specific payment prohibition that would not allow the supplier to receive Medicare payment for a CPAP device if that supplier, or its affiliate as defined above, is directly or indirectly related to the provider of the sleep test that would used to diagnose the beneficiary with OSA.

In this final rule, in response to public comment, we are adding additional definitions for ``affiliate'', and ``attended facility-based polysomnogram'', and clarify the definitions of ``Continuous positive airway pressure (CPAP)'', and ``sleep test.'' In addition, we are adding a new paragraph (g), which would create an exception to the prohibition contained in (f) if the sleep test is an attended facility- based PSG.

The following is a summary of the comments we received and our responses.

Comment: Many commenters maintained that the prohibition is unfair and that it ``singles out'' sleep diagnostics and therapies for a special payment prohibition. They maintain that there is no evidence that sleep tests promote ``self interested'' referrals any more than do referrals from any other diagnostic tests.

Response: We disagree. During the process leading to the revised

NCD, we received many public comments expressing concern that financial incentives involving sleep test providers being affiliated with CPAP suppliers might very well lead to abusive practices that would harm

Medicare beneficiaries and threaten the integrity of the Medicare program.

As we noted above, testing for the diagnosis of OSA will expand into settings that are not regulated as health care facilities. CPAP for the treatment of OSA differs from many other DME items in several ways that are significant here. The clinical symptoms that prompt the use of CPAP, for example, snoring, sleeplessness, daytime drowsiness, generally occur in the home setting and are self reported by the patient. The physical findings of patients with OSA are also seen in persons who do not have OSA.

The diagnosis of OSA which may lead to coverage of CPAP hinges upon the results of a clinical examination and a diagnostic test, the single night sleep study. The interpretation of a sleep study is subject to inter-interpreter variability. Sleep study results are known to vary from night to night and are also technique dependent. Other conditions for which Medicare covers DME, for example chronic obstructive pulmonary disease, are generally diagnosed based on the combined results of multiple tests such as chest x-rays, arterial blood gas measurements and pulmonary function tests. Thus it is less likely that a diagnosis of OSA will be supported by consistent findings across multiple test platforms. We are concerned that the provider of a sleep test will have a bias to interpret an inconclusive sleep test as positive if that provider has a financial interest in the payment for the CPAP device that would be used to treat the beneficiary. We believe that this represents a vulnerability to the Medicare program.

We believe that we have sufficient reason to believe that OSA and

CPAP are more amenable to fraud and abuse than some other items and services. We have seen program vulnerabilities in a similar benefit, specifically oximetry testing in the home for coverage of the home use of oxygen. For example, our local contractors informed us that laboratories and DME suppliers were, without an order from the treating physician, initiating oximetry testing. As a result, we acted to prohibit DME suppliers from furnishing the oximetry testing used in part to establish the beneficiary's eligibility for home oxygen coverage.

Comment: Several commenters state that the best models utilize high degrees of coordination and affiliation. The commenters claim that integrated care models result in higher CPAP compliance and better quality of care for the patient. The commenters state that the proposed rule would force integrated sleep management programs to refer beneficiaries to outside entities for the CPAP device, thus creating a break in continuity and accountability. During the public comment period on the proposed rule, several institutional stakeholders noted that if finalized unchanged, the regulation would essentially eliminate integrated sleep management programs that furnish coordinated management of OSA from testing to therapy including provision of CPAP.

The commenters claimed that these programs, all facility-based, provide a level of patient support in ensuring appropriate provision and titration of CPAP that is not typical with many DME suppliers. These programs note that under this scenario they would have reduced ability to monitor the beneficiary's compliance with CPAP, including ensuring that the CPAP device has been and continues to be optimized for the individual beneficiary. The commenters believe that finalization of the proposed rule would remove this option, thus they believe leading to fragmented care, loss of accountability and potential harm to patients.

Response: Integrated sleep management programs furnish comprehensive diagnostic and therapeutic services with a single coordinated program that commonly includes ongoing assessment of the patient's response to therapy and modifications to therapy as needed.

If finalized as proposed, the regulation would likely result in these programs referring all beneficiaries to outside DME suppliers for the CPAP device, thus creating a break in continuity of care.

This concern, which we recognize with attended facility-based PSG furnished in integrated sleep management programs, is not applicable outside of this setting. There is no substantive claim of continuity of care and coordinated disease management in other settings where a sleep test provider may have some other relationship with a DME supplier.

Our administrative contractors informed us that they have not historically found these integrated sleep management programs furnishing attended facility-based PSG to be a significant vulnerability. We cannot at this time confidently exclude the possibility that disrupting this model of care might be harmful to some patients. To avoid disrupting established integrated sleep management programs, this final rule with comment period will not prohibit DME payment to suppliers of CPAP to beneficiaries who have been diagnosed with OSA using attended facility-based PSG.

We are unaware of a reliable way to prospectively distinguish bona fide integrated sleep management programs from other entities for the purposes of this regulation. As we note below, there

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is no currently available accreditation program under which an entity can, under a single certificate, be accredited for sleep diagnosis and the supply of CPAP treatment. Thus we considered how to balance these concerns and minimize disruptions to continuity of care while maintaining the necessary protections for the Medicare program and its beneficiaries.

We believe that creating an exception for facility-based PSG strikes a reasonable balance of these concerns. In the context of OSA diagnosis and treatment for Medicare beneficiaries these integrated sleep management programs have historically (before the March 2008 NCD) used attended facility-based PSG for OSA diagnosis, as alternative diagnostic strategies did not support Medicare coverage of the CPAP device.

Excepting attended facility-based PSG from the payment prohibition for CPAP does not exempt HST furnished by the same entity, that is, the exception is at the test level not the program or facility level. Thus, this final rule with comment period avoids disrupting established integrated sleep management programs when they furnish attended facility-based PSG while affording the public more time to propose alternatives.

Comment: Several commenters stated that they would be forced to provide supplementary, nonreimbursable services to CPAP patients as a result of the rule. Sleep clinicians point to the fact that follow-up care of an OSA patient is a requirement for AASM accreditation. The commenters stated that under the provisions of the proposed rule, the

DME supplier would be reimbursed for the care, even when the DME fails to furnish the follow up care.

Response: We disagree. We expect that treating physicians and other recognized clinicians who evaluate and manage beneficiaries' sleep apnea would continue to submit claims for Medicare payment for the services that they furnish. This rule does not prohibit treating physicians from appropriately providing follow up care to their patients who use CPAP. A DME supplier that is not also enrolled by

Medicare as a physician would not furnish services that are properly within the scope of practice of the beneficiary's physician, and we would not expect to receive claims for Medicare payment for such services.

Comment: Several commenters suggested that accredited entities should be exempt from the prohibition. Some commenters have proposed that facilities that have been accredited by a recognized accrediting body to provide full diagnostic, therapeutic, and DME services should have an exception from the prohibition required as stated in the proposed rule.

Response: We agree that an entity that has been accredited by a recognized sleep therapy accrediting body would likely have protections in place that would minimize the potential fraud and abuse concerns we addressed above. We believe that the scope of such accreditation programs should be broad enough to include OSA diagnosis and the supply of CPAP treatment under a unified certificate.

We have contacted JCAHO and AASM (American Academy of Sleep

Medicine) to determine whether either has an accreditation program that could be applied to an integrated sleep management program that includes complete patient management to include managing the DME. AASM accredits sleep testing but not DME; JCAHO has nonspecific criteria that might be applied to the testing and DME supplier separately.

However, we are unaware of any current model that would encompass both under a single accreditation certificate. One commenter estimated that it would take approximately 6 months to develop such an accreditation framework. We expect that it would take 1 to 2 years to implement and accredit sufficient programs to make this a viable alternative.

Ideally, we would like to require that all entities that furnish both sleep testing and CPAP be accredited. We solicit public input on accreditation models that might support this option. Once we are made aware of appropriate accrediting models, we may readdress this issue in future rulemaking.

Comment: Several commenters expressed concern regarding the delays from time of OSA diagnosis to time of CPAP treatment that might arise if the beneficiary is supplied CPAP from an unaffiliated supplier. The commenters believe that this will have an adverse impact on the patient and will affect their follow through related to the plan of care.

Response: OSA is not an acute condition. We are not aware of credible evidence of serious harm due to delay of days or weeks between

OSA diagnosis and CPAP treatment.

The attended facility-based PSG testing paradigm may include same night initiation and titration of CPAP treatment. The final rule provides an exception for attended facility-based PSG. Thus, we believe that the exception provides a reasonable option should the beneficiary's treating physician determine that there is a pressing need for urgent treatment in the case of an individual beneficiary.

Comment: Several commenters believe that the adoption of this rule would cause disruptions in care of OSA treatments for patients in rural areas by imposing new restrictions. These commenters expressed wishes for a Stark-like rural exception, based on access to care arguments.

Response: Though various commenters have compared the provisions of this rule to the ``Stark'' rules, this rule is distinct from Stark and addresses separate concerns.

We acknowledge that rural beneficiaries are more likely to live at greater distances from sleep facilities. Thus, these beneficiaries would be more likely to avail themselves of home sleep testing if it were available.

We also note that the final rule allows an exception for attended facility-based PSG. Thus, when compared to Medicare coverage before the

March 2008 NCD expansion, the final rule's provisions in this regard do not impose new restrictions for Medicare beneficiaries located in rural areas. Therefore we believe that a specific rural exception is not needed at this time.

Comment: Many commenters state that existing fraud and abuse laws adequately address abuses arising out of affiliations. For example, the commenters stated that the Stark regulations do not allow a physician who has a financial relationship (ownership or compensation) with a DME supplier to refer a patient to that DME supplier for CPAP, unless an exception applies. In addition, commenters stated that under many State regulations a physician cannot have a substantial ownership interest in a DMEPOS supplier and still refer Medicare patients for DME. The commenters also state that fraud and abuse is prevented by other

Medicare provisions, such as those limiting coverage of CPAP to a 12- week period to identify beneficiaries diagnosed with OSA who benefit from CPAP.

Response: We disagree. While Stark and other statutes and rules, including the Federal anti-kickback statute, afford some protections, we believe this regulation to be necessary in order to further protect

Medicare beneficiaries from potential abusive practices and to further reduce the Medicare program's vulnerability to fraud and abuse. We believe that the payment prohibition for CPAP in this rule will be applied to a broader set of CPAP supplier relationships than would be prohibited under Stark. We here address additional CPAP supplier relationships that do not

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necessarily depend on a relationship with the beneficiary's treating physician who makes a referral, for example, a relationship between a sleep test provider and a DME supplier when the provider of the sleep test is not the beneficiary's treating physician who made the referral for the test.

Comment: One commenter stated that this proposal is unlawful.

First, the commenter stated that general rulemaking authority cannot support a ``Stark-like'' proposal such as the one under consideration.

Further, the commenter states that the preamble lacks sufficient facts or data to support the statutory predicate under section 1871(a)(1) that the rule must be ``necessary to carry out the administration'' of the Medicare program. The commenter summarizes their concerns by stating that the general grant of rulemaking authority is not plenary.

The commenter also stated that the rule is inconsistent with the Stark statute and it's implementing regulations, which the commenter asserted would not preclude a physician from selling a CPAP device to his or her patient if the physician is enrolled as a DME supplier and personally furnishes all of the services associated with the provision of the

CPAP. In addition, the commenter concludes that this rule is in direct contradiction to the Stark law because, unlike the Stark law, this rule does not contain an exception for referrals made by a physician who has an ownership or investment interest in a ``rural provider.''

Response: We do not agree. Our authority for promulgating this rule is supported by two different provisions in the Act. First, we believe that section 1871(a)(1) of the Act, which authorizes the Secretary to

``prescribe such regulations as may be necessary to carry out the administration of the insurance programs under this title,'' provides sufficient authority for this regulation. We believe that the prevention of fraud and abuse in the provision of CPAP devices is essential to the efficient administration of the Medicare program.

While the use of unattended HSTs will provide more beneficiaries with access to diagnosis and treatment of OSA, we are concerned that the increased number of unattended HSTs will in turn increase the potential for a test provider's affiliation with a CPAP supplier to lead to overutilization as we discussed above. We believe that the administration of the Medicare program includes a responsibility to protect the program and its beneficiaries from the harmful effects of fraud and abuse. Second, we also believe that section 1834(j)(1)(B)(ii)(IV) of the Act, which requires suppliers of equipment and supplies to ``meet such other requirements as the Secretary may specify,'' provides sufficient authority for this regulation.

We also disagree with the commenter's assertion that a physician's furnishing of CPAP can easily escape the purview of Stark and that this rule therefore conflicts with the Stark law. As we stated in the

``Phase III'' Stark final rule, although personally performed services are not a ``referral'' for Stark purposes, ``the dispensing of CPAP equipment by a physician would almost always constitute a ``referral''

* * *, as would the dispensing of CPAP equipment by anyone else affiliated with the referring physician, such as a nurse or physician assistant'' (72 FR 51020). This is because a referring physician claiming to personally provide DME must personally furnish the CPAP equipment as well as personally perform all activities necessary to satisfy the DME supplier standards. Thus, in all but the rarest of circumstances, the prohibition promulgated under this final rule does not conflict with the Stark prohibition as applied to physicians who refer for and furnish CPAP in their own medical practices. Moreover, given our general rulemaking authority and our authority under section 1834(j)(1)(B)(ii)(IV) of the Act, we are not prevented from regulating the provision of CPAP in those unusual circumstances in which Stark is not implicated because there has been no ``referral.''

Similarly, we do not agree with the commenter's assertion that this rule conflicts with the Stark prohibition because it does not contain an exception for referrals made by a physician who has an ownership or investment interest in a ``rural provider.'' Under the Stark statute, section 1877(d)(2) of the Act, there ``shall not be considered to be an ownership or investment interest * * * [i]n the case of designated health services [including DME, such as CPAP] furnished in a rural area

(as defined in section 1886(d)(2)(D)) by an entity, if * * * substantially all of the designated health services furnished by the entity are furnished to individuals residing in such a rural area.''

Thus, Stark is not implicated in those circumstances. Nevertheless, we are not precluded from using other authority to limit or prohibit payment for items and services that are provided in a manner that does not implicate Stark. Notwithstanding Stark, we have authority under sections 1871(a)(1) and 1834(j)(1)(B) of the Act to issue this rule.

Comment: One commenter stated concerns that the rule will limit appropriately trained and qualified DMEPOS suppliers' ability to furnish home sleep tests. The association claims that the rule creates unnecessary and artificially high barriers to DMEPOS suppliers' ability to furnish services that are uniquely within their area of expertise.

The commenter stated that the DME business model is premised on the ability to furnish medical equipment to patients in their homes and

DMEPOS suppliers may be the only providers with the immediate capacity to furnish HST to Medicare beneficiaries.

Response: Only the physician treating the beneficiary can order a

HST and prescribe CPAP therapy. We expect that the sleep test would be interpreted by a physician, and we do not believe CPAP suppliers should be paid for supplying CPAP equipment when an affiliated physician has interpreted the HST or ordered the equipment. We are not persuaded that

DME suppliers have any uniquely valuable expertise in the provision of diagnostic testing.

Comment: Many commenters claimed the regulation will result in an under availability of CPAP equipment and services in many communities.

One commenter explained that IDTFs are now permitted to utilize HST to diagnose OSA, but point out that the vast majority of IDTFs do not have the resources and infrastructure needed to deliver or pick-up HST equipment to and/or from the beneficiary's home. The commenter requested that CMS furnish a detailed analysis on beneficiary access to

CPAP supplies and services locally before implementing such a provision.

Response: This rule does not prohibit IDTFs from establishing and maintaining sufficient resources and infrastructure to deliver or pick up HSTs, so long as the DME supplier who will be furnishing the CPAP to the beneficiary as a result of the HST is not the same DME supplier that the IDTF has affiliated with for purposes of delivering or picking up the HSTs or performing other functions related to providing the HST.

In addition, the exception we are providing for attended facility-based

PSG is sufficient to maintain beneficiary access at historical levels before the 2008 NCD.

Comment: One commenter stated that the mission of all nonprofit healthcare systems includes furnishing care for the under and un- insured populations. The commenter stated that healthcare systems would no longer furnish sleep tests to the under and uninsured if the healthcare system is prohibited from furnishing CPAP devices to

Medicare beneficiaries.

Response: It is not clear to us why a nonprofit would refuse to offer HSTs to

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the under- or uninsured simply because the nonprofit entity cannot use an affiliated DME supplier to furnish a CPAP device prescribed after the HST. We note that health care entities can continue to provide CPAP when prescribed as a result of an attended facility-based PSG.

Comment: One commenter points to guidance issued in mid 2002, where

CMS recognized a separation between a hospital system and its ownership of a DME business (otherwise referred to as a Hospital-based supplier).

By enacting this provision, the commenter concludes that CMS would no longer recognize this separation. The commenter concludes that this provision, if enacted, would result in other prohibitions for follow-up care following a diagnostic test.

Response: We disagree with the commenter's conclusion, and we note that the final rule's exemption of attended facility-based PSG would likely apply to many hospital affiliated sleep programs.

Comment: Several commenters stated that there is a clear conflict of interest for the provider of the test to also profit from the provision of the CPAP therapy.

Response: We appreciate the supportive comments.

Comment: Several commenters wrote that physicians who work for hospitals are under increasing pressure to generate revenue by conducting more tests and prescribing CPAP through a hospital owned DME supplier. Other commenters claim that bonus payments are made to physician's who prescribe CPAP through a hospital owned DME supplier.

These commenters favor the payment prohibition.

Response: We appreciate the overall concerns expressed by the commenters about pressure on physicians, but we wish to minimize the disruption to programs that were in place prior to the March 2008 NCD expansion of coverage. We believe that an exemption for attended facility-based PSG is a reasonable balance between beneficiary access and protection at this time.

Comment: Several commenters support a payment prohibition where the diagnostic test facilities are not permitted to provide the CPAP and related supplies. According to the commenters, the DMEPOS suppliers claim to possess a higher degree of sophistication surrounding CPAP technologies and related supplies by focusing exclusively on the technologies rather than on the sleep diagnostics.

Response: We appreciate the supportive comment on the proposed regulation. However we have been persuaded for reasons described above to except attended facility-based PSG from the payment prohibition for

CPAP.

Comment: Several commenters stated that hospital-owned DME qualifies as a monopoly, and results in an unfair competitive advantage for hospitals and large sleep centers. The commenters favor the payment prohibition and state that such a prohibition is good for small businesses.

Response: Business monopoly is beyond the scope of this regulation and we will not discuss it here.

Comment: Several commenters stated that the term ``affiliate'' is ambiguous, and that the proposed rule is vague and overly broad in its use of the terms ``affiliate'' and ``directly or indirectly''. The commenters requested that CMS provide a clear definition of

``affiliate''. The commenters stated that without clear definitions from CMS it is impossible to discern what types of affiliations CMS intends to preclude under the rule or how the proposed rule would apply to any given set of circumstances. One commenter recommended that a definition of affiliate be common ownership of greater than 50 percent of the supplier of the CPAP device.

Response: We define ``affiliate'' as a person or organization that is related to another person or organization through a compensation arrangement or some type of ownership.

We have defined a provider of sleep test as an individual or entity that directly or indirectly administers and/or interprets the test and/ or furnishes the sleep test device. By indirect we mean that one or more intermediary actors are used to accomplish the sleep test to its end. For example, if a DME supplier contracted with a sleep test provider to furnish HST, that supplier would indirectly provide the

HST. Directly providing the test means there are no intermediary actors--no intervening persons or entities between them.

Comment: One commenter requested that sleep labs be permitted to develop criteria to gauge the competency of the DME. Further, the commenter requested that sleep labs be permitted to use such criteria to discriminate against DME companies who fail to perform at an acceptable level of competency.

Response: We believe that this concern can be addressed through the development and implementation of accreditation standards. Ideally, we would like to require that all entities furnishing sleep tests in any settings in addition to supplying CPAP be accredited. Once we are made aware of appropriate accrediting models, we will readdress the issue in future rulemaking.

Based on section 1871(a)(1) of the Act, which provides the

Secretary with the authority to ``prescribe such regulations as may be necessary to carry out the administration of the insurance programs under this title,'' and section 1834(j)(1)(B)(ii)(IV), which requires suppliers of equipment and supplies to ``meet such other requirements as the Secretary may specify,'' and due to our concerns with respect to the potential for unnecessary utilization of sleep tests, we shall prohibit payment to the supplier of the CPAP device when such supplier or its affiliate is directly or indirectly the provider of the HST that is used to diagnose a Medicare beneficiary with OSA.

We considered several options. We considered whether a narrower prohibition could reasonably accomplish the purposes of this regulation at this time. Exceptions for providers that offer integrated sleep management programs were considered. We also considered allowing an exception for nationally accredited disease management programs but we are unaware of any current model that would encompass accreditation for both OSA diagnosis and CPAP supply under a single accreditation certificate.

After reviewing the public comments, we are finalizing the prohibition in Sec. 424.57 as proposed but with an exception for attended facility-based PSG. Excepting facility-based PSG from the prohibition on providing CPAP would not except HST performed by the same entity, that is, the exception is at the test level not the facility level. We plan to solicit public input on accreditation models that might support future exceptions to this prohibition. We add additional definitions for ``affiliate'', ``attended facility-based polysomnogram,'' and clarify the definitions of ``Continuous positive airway pressure (CPAP)'' and ``Sleep test''. 3. Beneficiary Signature for Nonemergency Ambulance Transport Services

In the CY 2008 PFS final rule with comment period (72 FR 66406), we created an additional exception to the beneficiary signature requirements, applicable for emergency ambulance transports, in Sec. 424.36(b)(6). The exception allows ambulance providers and suppliers to sign on behalf of the beneficiary, at the time of transport (that is, the time during which the beneficiary is picked up and dropped off at the receiving facility), provided that certain documentation requirements are met. To take advantage of the exception at Sec. 424.36(b)(6), an

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ambulance provider or supplier must maintain in its files: (1) A contemporaneous statement, signed by an ambulance employee who is present during the trip, that the beneficiary was mentally or physically incapable of signing (and that no other authorized person was available and or willing to sign); (2) documentation as to the date, time and place of transport; and (3) either a signed contemporaneous statement from the receiving facility that documents the name of the beneficiary and the date and time the beneficiary was received by that facility, or a secondary form of verification from the facility that is received at a later date.

In the CY 2008 PFS final rule with comment period (72 FR 66324), we clarified that, apart from the new exception in Sec. 424.36(b)(6), where a beneficiary is unable to sign a claim at the time the service is rendered, ambulance providers and suppliers are required to use reasonable efforts to follow-up with the beneficiary and obtain his or her signature before submitting the claim with a signature from one of the individuals or entities specified in Sec. 424.36(b)(1) through

(b)(5). We further clarified that only providers of services, and not ambulance suppliers, can take advantage of Sec. 424.36(b)(5), which states that a representative of the provider or of the nonparticipating hospital may sign on behalf of the beneficiary if the provider or nonparticipating hospital was unable to have a claim signed in accordance with Sec. 424.36(b)(1) through (b)(4) (72 FR 66322).

Subsequent to publication of the CY 2008 PFS final rule with comment period, ambulance provider and supplier stakeholders requested that we extend the exception in Sec. 424.36(b)(6) to nonemergency ambulance transports in instances where the beneficiary is physically or mentally incapable of signing. These stakeholders stated that there are many nonemergency transports for which a beneficiary is physically or mentally incapable of signing a claim form. For example, stakeholders asserted that beneficiaries residing in long term care facilities often need to be transported for nonemergency medical treatment, yet may be incapable of signing the claim due to physical or mental ailments, such as Alzheimer's disease or other forms of dementia. In these instances, there may be no other individual who is immediately available and authorized to sign the claim as specified in

Sec. 424.36(b).

Because we do not anticipate an increased risk of fraud or program abuse if the exception in Sec. 424.36(b)(6) is extended to include nonemergency transports, we proposed to revise Sec. 424.36(b)(6) to refer specifically to nonemergency transports. We also proposed to add language to Sec. 424.36(a) to clarify that, apart from the use of the exception in Sec. 424.36(b)(6), providers and suppliers must make reasonable efforts to obtain the beneficiary's signature before relying on one of the exceptions in Sec. 424.36(b). We note that Sec. 424.36(b)(5) specifies that a provider may not invoke the exception to sign a claim on behalf of a beneficiary unless it is unable to have one of the persons specified in Sec. 424.36(b)(1) through (b)(4) sign the claim. Finally, given that most claims are submitted electronically, we proposed to amend Sec. 424.36(a) to define ``claim'' for purposes of the beneficiary signature requirements as the claim form itself or a form that contains adequate notice to the beneficiary or other authorized individual that the purpose of the signature is to authorize a provider or supplier to submit a claim to Medicare for specified services furnished to the beneficiary.

We received comments that urged us to eliminate entirely the beneficiary signature requirement where a beneficiary is mentally or physically incapable of signing a claim and no other person authorized to sign a claim on behalf of the beneficiary is available or willing to sign at the time of transport. In addition, the commenters stated that the proposed documentation requirements would be costly and burdensome to ambulance providers and suppliers. Several commenters objected to our proposal to amend Sec. 424.36(a) to clarify that, apart from the use of the exception in Sec. 424.36(b)(6), providers and suppliers must make reasonable efforts to obtain the beneficiary's signature before relying upon one of the exceptions in 424.36(b).

We are adopting our proposals, with modification. Specifically, we are amending the exception in Sec. 424.36(b)(6) to include nonemergency ambulance transports. We are also amending Sec. 424.36(a) to define ``claim'' for purposes of the beneficiary signature requirements, as the claim form itself, or a form that contains adequate notice to the beneficiary or other authorized individual that the purpose of the signature is to authorize a provider or supplier to submit a claim to Medicare for specified services furnished to the beneficiary. We are revising Sec. 424.36(b)(6)(ii)(C)(2) to include secondary forms of verification from either a hospital or a facility.

The following is a summary of the comments we received and our responses.

Comment: The majority of commenters stated that it is a burden on ambulance providers and suppliers to obtain a signature for nonemergency ambulance transports when a beneficiary is mentally incapable of signing the ``waiver.'' The commenters contended that asking for additional documentation to verify that a patient was transported creates a financial burden on the ambulance provider. One commenter stated that its billing office has to do more mailings, follow-up calls and faxes to get a ``waiver'' completed, and that spouses are reluctant to sign the form for fear that they will be responsible for the ambulance transport bill. The commenter also stated that the forms are confusing to its ambulance crew and that hospital and rehabilitation representatives are reluctant to sign forms. One commenter suggested that checking hospital and rehabilitation bills would be an easier way to document a patient transport, whereas another commenter suggested that we should abolish the signature requirement entirely.

Response: We note that whereas several commenters referred to a

``waiver'' of the signature requirement of Sec. 424.36, in fact Sec. 424.36 sets forth a signature requirement and alternative means of satisfying the signature requirement. That is, Sec. 424.36 generally requires that the beneficiary sign the claim, unless the beneficiary is deceased or unavailable to sign the claim, in which case other individuals or entity representatives (as enumerated in Sec. 424.36(b), (c) and (d)) may sign the claim. We are adopting our proposal to amend Sec. 424.36(a) to clarify that ``the claim'' includes the actual claim form or such other form that contains adequate notice to the beneficiary or other authorized individual signing on behalf of the beneficiary that the purpose of the signature is to authorize a provider or supplier to submit a claim to Medicare for specified services furnished to the beneficiary. The purpose of the beneficiary signature is to verify that the services were in fact rendered and were rendered as billed.

Our proposal does not impose any new burdens on ambulance providers or suppliers, but rather offers an optional, alternative method, for satisfying the beneficiary signature requirement. We do not agree with the commenters that it is a significant burden on ambulance providers and suppliers to comply with the proposed signature and documentation requirements in order to meet the proposed exception for nonemergency ambulance transports when a beneficiary is incapable of signing a claim form; however, those

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ambulance providers and suppliers that believe that the signature and documentation requirements of the new exception at Sec. 424.36(b)(6) are burdensome may avail themselves of the other means specified in

Sec. 424.36 for satisfying the beneficiary signature requirement.

In response to the assertion that the forms are confusing, we reiterate that we did not create any new forms for ambulance personnel or facility staff to sign. Ambulance providers or suppliers may use whatever forms they wish (such as the patient care trip report, etc.) for capturing the signature and documentation requirements specified in

Sec. 424.36(b)(6). In response to the assertion that spouses are reluctant to sign a form for fear that they will be responsible for the ambulance transport bill, signing of the claim form (or such other form used as a proxy for the claim form) does not make a person financially liable to pay the provider or supplier. However, if a beneficiary or the beneficiary's authorized representative refuses to sign the claim form, the ambulance company may bill the beneficiary directly for the transport service. In addition, if the transport service is deemed not medically necessary, and thus is not covered by Medicare, the beneficiary may be held responsible for payment (subject to the limitation of liability provisions of section 1879 of the Act and our regulations at Sec. Sec. 411.404).

We are not persuaded to adopt the suggestion that we eliminate entirely the beneficiary signature requirement for ambulance transports. We are concerned that there may be an increased risk of fraud or program abuse if we were to remove the signature requirement.

Moreover, we did not propose to eliminate the signature requirement and therefore may lack the authority to abolish the requirement through this final rule even if we were otherwise inclined to do so. With respect to the suggestion that we should check hospital and rehabilitation bills to document a patient transport (which is tantamount to suggesting that we eliminate the signature requirement), we do not agree that it should be the program's responsibility, at the time of processing the claim, to guess whether the beneficiary would have authorized the claim if asked, or to have to secure documentation from providers and suppliers (which, to the extent that they have not furnished the transport, may not be required to supply us with such documentation and may even be precluded by privacy laws from supplying us with such documentation). Accordingly, we believe providers and suppliers should go on record, at the time of submitting the claim, that the beneficiary (or someone authorized on his behalf) authorized the filing of the claim.

Comment: Several commenters noted that, in light of our proposal to expand the (b)(6) exception to include nonemergency ambulance transports as well as emergency ambulance transports, the signature requirements may apply when a beneficiary is being transported from or to skilled nursing facilities, hospitals and other permissible destinations. Therefore, the commenters requested that we revise Sec. 424.36(b)(6)(ii)(C)(2), which makes reference to ``the hospital registration/admission sheet'', ``the hospital log'', or ``other internal hospital records,'' and replace ``hospital'' with

``facility.''

Response: We agree with the commenter that there may be nonemergency transports where the beneficiary is being transported from or to skilled nursing facilities, hospitals and other permissible destinations. Thus, we are revising Sec. 424.36(b)(6)(ii)(C)(2) to replace ``hospital'' with ``hospital or other facility''.

Comment: One commenter requested that we clarify whether secondary forms of verification must be signed by a representative of the receiving facility. In response to a similar request for clarification in the CY 2008 PFS final rule (72 FR 66323) we stated that secondary forms of verification did require a signature; however, this requirement was not included in the text of Sec. 424.36(b)(6)(ii)(C)(2), as finalized in the CY 2008 PFS final rule. The commenter also stated that hospitals are moving toward electronic recordkeeping, and urged us to clarify that secondary forms of documentation used to verify transport do not need to be signed by a representative of the facility, provided that the form of documentation obtained is an official facility record that clearly indicates the name of the patient, and the date and time the patient was received by or transported from that facility.

Response: We acknowledge that, although the preamble language in the CY 2008 PFS final rule stated that all forms of secondary documentation used to verify transport need to be signed by a representative of the receiving facility, the regulation text at Sec. 424.36(b)(6), as published in the 2008 CY PFS final rule, did not include this specific requirement. We are clarifying Sec. 424.36(b)(6)(ii)(C)(2)to provide that secondary forms of documentation used to verify transport do not need to be signed by a representative of the receiving facility if the form of documentation obtained is an official hospital or facility record, (such as the facility or hospital registration/admissions sheet, patient medical record, facility or hospital log, or other facility or hospital record), and it documents the beneficiary's name, date, and time the beneficiary was received by that facility.

Comment: Several commenters objected to our proposal to clarify

Sec. 424.36(a) to state that a provider or supplier must make

``reasonable efforts to locate and obtain the beneficiary's signature'' before a provider or supplier could rely upon one of the exceptions set forth in Sec. 424.36(b)(1) through (5).

Response: We are not adopting our proposal because, having reexamined the issue, we believe that the current language in Sec. 424.36(b)(5) provides adequate protection for the beneficiary and the

Medicare program. Prior to, and during the course of, the CY 2008 PFS rulemaking, we were alerted to the fact that some ambulance providers and suppliers were signing the claim on behalf of the beneficiary simply because the beneficiary was not able to sign the claim at the time of transport. We clarified in the preamble to the CY 2008 PFS final rule with comment period that signing the claim on behalf of the beneficiary simply because the beneficiary was not able to sign the claim at the time of transport was not proper and, further, that only providers (and not suppliers) are eligible to use the exception at

Sec. 424.36(b)(5). Our decision to make an exception to the requirement that reasonable efforts must be made to obtain the signature of the beneficiary, by creating a new exception at Sec. 424.36(b)(6) in the CY 2008 PFS final rule with comment period for emergency ambulance transports, and in this final rule for nonemergency ambulance transports, and to allow the provider or supplier to sign the claim on behalf of the beneficiary at the time of the service, provided certain safeguards are met, was a deliberate departure from the general rule. However, because we amended Sec. 424.36(b)(5) in the CY 2008 PFS final rule with comment period to state that, before relying on that exception, providers must ``mak[e] reasonable efforts to locate and obtain the signature of one of the individuals specified in paragraph

(b)(1), (2), (3) or (4) of this section,'' rather than to state that the provider must first make reasonable efforts to locate and obtain the signature of the beneficiary, we are concerned that we might create confusion or add an unneeded degree of complexity if we were to finalize our proposal to amend Sec. 424.36(a) to state

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that a provider or supplier must make reasonable efforts to locate and obtain the beneficiary's signature before a provider or supplier could rely upon one of the exceptions set forth in Sec. 424.36(b)(1) through

(5). By requiring providers and suppliers to not sign claims on behalf of the beneficiary under Sec. 424.36(b)(5) without having first made reasonable efforts to procure the signature of the beneficiary or an authorized individual, we address our core concerns. It is true that, as clarified, our regulations allow providers and suppliers to procure the signature of an authorized individual in a situation where the beneficiary may be only temporarily unable to sign the claim, but, on balance, we believe it is preferable, for the sake of convenience, to give providers and suppliers some flexibility as to whether they obtain the signature of the beneficiary or that of an authorized individual.

With respect to ambulance providers and suppliers, the matter of making reasonable efforts to locate and obtain the signature of the beneficiary or another authorized individual should largely be moot.

Ambulance providers and suppliers should be able to rely on the exception at Sec. 424.36(b)(6) to sign the claim in the case of both emergency and nonemergency transports, provided they meet the documentation requirements therein. To the extent that ambulance providers and suppliers do not wish to, or are unable to, comply with the documentation requirements of Sec. 424.36(b)(6), they may obtain the signature of an authorized individual specified at Sec. 424.36(b)(1) through (b)(4) (including in the situation where one of the authorized individuals is available and willing to sign at the time of transport). Moreover, an ambulance provider (but not a supplier), may rely on the exception at Sec. 424.36(b)(5) to, itself, sign the claim, after having made reasonable efforts (including over a reasonable period of time) to locate and obtain the signature of either the beneficiary or an authorized individual.

Comment: Several commenters requested that we make the new exception in Sec. 424.36(b)(6) for nonemergency transports retroactive to January 1, 2008. Commenters also asked us to clarify in this final rule and/or in guidance on the CMS Web site that we will not take any adverse action against an ambulance provider or supplier that made good faith (but unsuccessful) attempts to comply with the beneficiary signature requirement rules prior to January 1, 2009. The commenters stated that, despite multiple attempts to obtain the required signatures from the beneficiary or the beneficiary's authorized representative, many ambulance providers and suppliers have been unsuccessful, and thus, they are holding claims for nonemergency transports. The commenters also asserted that ambulance providers and suppliers have experienced difficulty in obtaining signatures from facility representatives because of concerns that their signature would render the facility financially liable for the transport.

Response: We are not making the new exception in Sec. 424.36(b)(6) for nonemergency ambulance transports retroactive to January 1, 2008, and are not making an exception for good faith efforts to comply with the regulation as it existed prior to this final rule with comment period. There would be significant legal issues if we were to make the rule retroactive to January 1, 2008 or to waive the requirements as they existed prior to this final rule. Moreover, apart from the legal constraints, we are not persuaded that either course of action is warranted. The CY 2008 PFS final rule did not create any new burden for ambulance providers and suppliers (and, to the contrary, made it easier for ambulance providers and suppliers to comply with the beneficiary signature requirement for emergency transports). It did, however, clarify our longstanding policy that providers and suppliers must make reasonable efforts to obtain the beneficiary's signature before submitting the claim and that it was not sufficient for providers to submit the claim (utilizing the exception at Sec. 424.36(b)(5)) simply because the beneficiary was able to sign the claim at the time of transport. We also clarified that only providers, and not suppliers, may utilize the exception at Sec. 424.36(b)(5), consistent with the plain language of the exception. To the extent that, following the

November 27, 2007 final rule, ambulance providers and suppliers have found it difficult to obtain the beneficiary's signature for nonemergency transports (because they had not previously been following our rules), we have addressed their concerns in two ways. First, on

July 24, 2008, we placed guidance on the CMS Web site at http:// www.cms.hhs.gov/AmbulanceFeeSchedule/downloads/Guidance_On_

Beneficiary_Signature_Requirements_for_Ambulance_Claims.pdf that reiterated our position that ambulance providers and suppliers may utilize the exception at Sec. 424.36(b)(4), which allows facilities to sign on behalf of the beneficiary, and explained that such facilities do not assume liability for payment of the services simply by signing on behalf of the beneficiary. Second, in this final rule we are finalizing our proposal to expand the exception in Sec. 424.36(b)(6) to nonemergency transports. The new exception is effective for

``claims'' filed on or after January 1, 2009. Therefore, if claims have been held and are still within the timely filing limit, as specified in

Sec. 424.44, the claims may be submitted to Medicare for payment in accordance with the new exception.

Comment: A commenter recommended that the existing language in

Sec. 424.36(b)(6)(ii)(A) be modified to state that, in the case of an emergency transport, the general crew signature on an emergency ambulance incident report is sufficient to meet the requirements of

Sec. 424.36(b) and that a separate crew signature is not required. The commenter suggested, as an alternative, that if we determine that the signature of an ambulance employee present during the transport is necessary, it should be sufficient if the employee signature on the incident report is obtained ``after the fact,'' rather than contemporaneous with the transport. The commenter stated that it is necessary that we allow signatures obtained after the transport because the ambulance crew's primary concern is taking care of the patient, not doing paperwork, such as a signed incident report.

Response: We are not persuaded to modify the requirement in Sec. 424.36(b)(6)(ii)(A) to state that the general crew signature on an incident report is sufficient and that a separate crew signature is not required. We believe that the commenter's suggestion that any member of the general crew be permitted to sign the incident report as evidence that the service was rendered as billed would not satisfy our integrity concerns, because the general crew member would have no direct knowledge regarding the transport services. It is also our understanding that the ambulance crew completes a trip report that describes the condition of the beneficiary, treatment, origin/ destination, etc. Therefore, we believe it would be a minimal burden upon the ambulance crew signing the incident or trip report to prepare a statement detailing why the beneficiary is unable to sign a claim form at the time of transport. We also emphasize that Sec. 424.36(b)(6)(ii)(A) requires that a contemporaneous statement signed by an ambulance employee present during the trip be obtained. A contemporaneous statement, rather than one obtained after the fact, is necessary to meet our integrity concerns, that is,

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to verify that the trip took place as claimed on the bill.

Comment: Several commenters suggested that we eliminate the terms

``emergency and nonemergency ambulance transport services'' in Sec. 424.36(b)(6) and replace those words with ``ambulance services.''

Response: We are not persuaded to revise Sec. 424.36(b)(6) in the manner suggested by the commenters. Although readers familiar with the

Federal Register publications of the CY 2008 PFS final rule and the CY 2009 PFS final rule would realize that ``ambulance services'' would refer to both emergency and nonemergency transports, we wish the regulation text that will appear in the CFR to be clear on its own, particularly to readers who may be accessing the regulation years from now. Therefore, we believe it is preferable to retain the proposed language ``emergency and nonemergency ambulance transport services'' so as to leave no doubt that both emergency and nonemergency transports are covered by the exception in Sec. 424.36(b)(6). 4. Solicitation of Comments and Data Pertaining to Physician Organ

Retrieval Services

Since 1987, we have limited the amount an Organ Procurement

Organization (OPO) may reimburse a physician for cadaveric kidney donor retrieval services. Chapter 27 of the Provider Reimbursement Manual

(CMS-Pub. 15-1) limits the payment to a physician for cadaveric kidney retrieval to $1,250 per donor (one or two kidneys). Although the payments made to physicians for organ retrieval services associated with other types of organ transplants have increased, kidney retrieval rates have remained at $1,250. We have received several requests to change the amount we pay for kidney retrievals. To date, we do not have data upon which to base a change in payment.

In order to determine fair and reasonable payment for cadaveric organ retrieval services, we solicited public comments and data that are reflective of organ retrieval service costs. We did not limit our solicitation to costs associated with kidney retrieval services, but rather stated that we are interested in receiving comments and data pertaining to retrieval services for all types of organs. We indicated that we may use this information to determine the extent to which a recalculation of the payment for cadaveric organ retrieval services furnished by a physician is warranted and to inform any future rulemaking on this subject. Any future rulemaking would provide for notice and public comment.

We received four timely public comments in response to our request for information and data for use in updating the organ retrieval physician payment amount included in organ acquisition costs. The following is a summary of the comments we received and our responses.

Comment: The commenters believed that the kidney retrieval rate of

$1,250 per donor is insufficient and three of the commenters recommended that we increase that limit by either the Consumer Price

Index for all urban consumers (CPI-U) or the Medicare Economic Index.

Two commenters stated that little or no data on actual organ retrieval services exists, and that any rulemaking without such data would be inappropriate. The commenters stated that due to the extreme variability associated with these services, they had serious concerns as to the feasibility of establishing an accurate cost or payment for organ retrieval using an approach like that employed by the AMA's

Relative Value Scale Update Committee (RUC). According to the commenters, there are specific factors impacting the cost of organ retrieval including donor evaluation, travel and wait time, dry runs and other risks and costs. These factors contribute to the great variability in measuring the time and expense associated with organ retrieval services. These commenters offered to assist us in establishing a process to collect data for the purpose of updating the organ retrieval rates. One commenter stated that the retrieval rate should be paid per kidney and not per donor.

Response: We thank the commenters who responded to our solicitation of comments and appreciate the offer that some made to be involved in future efforts to design a revised payment method. We are not inclined to propose that the base organ retrieval rate for kidneys and other organs simply be increased by an indexed amount (such as the CPI-U) because we believe the base payment amounts for retrieval of the various organs may need to be updated. Therefore, we are again soliciting information from the transplant community. Specifically we would like to obtain information on the physician effort and resources required to procure an organ. These resources include surgical time, dry runs (number and percentage of retrievals in which an organ is not recovered), travel and wait times, as well as the incremental time required for extended criteria donors and donors after cardiac death.

Additionally, because currently we limit kidney retrieval physician reimbursement to $1,250 per donor, we would need resource information to determine the difference in procuring one kidney or a pair of kidneys from a single donor in order to determine a payment on a per kidney basis as suggested by a commenter. 5. Revision to the ``Appeals of CMS or CMS Contractor Determinations

When a Provider or Supplier Fails To Meet the Requirements for Medicare

Billing Privileges'' Final Rule

In the June 27, 2008 Federal Register, we published the ``Appeals of CMS or CMS contractor Determinations When a Provider or Supplier

Fails to Meet the Requirements for Medicare Billing Privileges'' final rule. In Sec. 405.874(b)(2), we stated, ``The revocation of a provider's or supplier's billing privileges is effective 30 days after

CMS or the CMS contractor mails notice of its determination to the provider or supplier. A revocation based on Federal exclusion or debarment is effective with the date of the exclusion or debarment.''

During the 30 days after CMS or our contractor mails a revocation notice to a provider or supplier, the provider or supplier is afforded the opportunity to submit a corrective action plan. A corrective action plan gives a provider or supplier an opportunity to provide evidence that demonstrates that the provider or supplier is in compliance with

Medicare requirements. Moreover, a provider or supplier can use a corrective action plan to correct the deficiency without filing an appeal under 42 CFR part 498, and remain in the Medicare program when the provider demonstrates that the provider or supplier is in compliance with Medicare requirements and the Medicare contractor accepts the corrective action plan. In those situations where a provider or supplier submits an acceptable corrective action plan, the provider or supplier maintains their billing privileges and the revocation determination is not implemented.

We maintain that providers or suppliers are able to provide sufficient evidence through a corrective action plan that demonstrates that they are in compliance with Medicare requirements when CMS or our contractor imposes a revocation based on certain types of adverse actions such as a Federal exclusion or debarment. Accordingly, consistent with revoking billing privileges with the date of exclusion or debarment, we believe that similarly situated revocations such as felony convictions and license suspension or revocation do not lend themselves to a

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corrective action plan and that the revocation should be effective with the date of the felony conviction or the license suspension or revocation. Moreover, we maintain that when CMS or our contractor determines that a provider or supplier, including a DMEPOS supplier, is no longer operating at the practice location provided to Medicare on a paper or electronic Medicare enrollment application that the revocation should be effective with the date that CMS or our contractor determines that the provider or supplier is no longer operating at the practice location.

Further, while we do not believe that revocations based on felony convictions, license suspension or revocation, or a revocation based on a provider or a supplier no longer being operational at a specific practice location, lend themselves to a corrective action plan, we believe that these providers and suppliers should be afforded appeal rights in 42 CFR part 498. We believe that the appeals process will permit a provider or supplier who believes that CMS or our contractor has made an incorrect decision regarding revocation based on Federal exclusion or debarment, felony conviction, license suspension or revocation, or when we have determined that the provider or supplier is no longer operating at the practice location the opportunity to have

CMS or our contractor reconsider its initial revocation determination.

Accordingly, we proposed to revise Sec. 405.874(b)(2) from, `` The revocation of provider's or supplier's billing privileges is effective 30 days after CMS or the CMS contractor mails notice of its determination to the provider or supplier. A revocation based on

Federal exclusion or debarment is effective with the date of the exclusion or debarment.'' to ``The revocation of a provider's or supplier's billing privileges is effective 30 days after CMS or the CMS contractor mails notice of its determination to the provider or supplier, except if the revocation is based on Federal exclusion or debarment, felony conviction, license suspension or revocation, or the practice location is determined by CMS or its contractor not to be operational. When a revocation is based on an exclusion or debarment

Federal exclusion or debarment, felony conviction, license suspension or revocation, or the practice location is determined by CMS or its contractor not to be operational, the revocation is effective with the date of exclusion or debarment, felony conviction, license suspension or revocation or the date that CMS or its contractor determined that the provider or supplier was no longer operational.''

In addition, to ensure consistency, we proposed to revise Sec. 424.535(f) (redesignated as Sec. 424.535(g)) from, ``Revocation becomes effective within 30 days of the initial revocation notification.'' to ``Revocation becomes effective 30 days after CMS or the CMS contractor mails notice of its determination to the provider or supplier, except if the revocation is based on Federal exclusion or debarment, felony conviction, license suspension or revocation, or the practice location is determined by CMS or its contractor not to be operational. When a revocation is based on a Federal exclusion or debarment, felony conviction, license suspension or revocation, or the practice location is determined by CMS or its contractor not to be operational, the revocation is effective with the date of exclusion or debarment, felony conviction, license suspension or revocation or the date that CMS or its contractor determined that the provider or supplier was no longer operational.''

We believe that these changes will ensure that providers and suppliers are afforded due process rights under 42 CFR part 498, but also ensure that Medicare is not making or continuing to make payments to providers and suppliers who are no longer eligible to receive payments.

We solicited comments on whether we should establish an expedited reconsideration process for providers and suppliers for when we issue a revocation for the following reasons: (1) Federal debarment or exclusion, (2) felony conviction, (3) license suspension or revocation, or (4) when CMS or our contractor determines that the provider is not operational at the practice location provided to Medicare and the provider or supplier furnishes sufficient evidence to demonstrate that

CMS or our contractor made a factual error when issuing the initial revocation determination.

In addition, we solicited comments on whether CMS or our contractors should consider processing expedited reconsiderations within a specified time period such as 30 days of the date the provider or supplier furnishes sufficient evidence to make a reconsideration determination.

The following is a summary of the comments we received and our responses.

Comment: Several commenters recommended that we withdraw our proposed changes to the appeals process.

Response: We disagree with these commenters because we continue to believe that we should not make further payments to physicians and NPPs who have had their State medical license suspended or revoked, were convicted of a felony as described in Sec. 424.535(a)(3), were excluded or debarred from participating in a Federal program, or were determined by CMS or its contractor not to be operational.

Comment: One commenter urged CMS to require contractors to send revocation notices in an effective manner that would establish a date of receipt and the recipient.

Response: While this comment is outside the scope of the proposed rule, Medicare contractors are instructed to mail revocation notices to the correspondence address of the provider.

Comment: One commenter recommended that we create an expedited reconsideration process of not more than 30 days in cases where revocation is based on CMS/contractor error.

Response: While we have considered establishing an expedited reconsideration process for those cases in which Medicare revoked billing privileges due to a Federal exclusion or debarment, a felony conviction as described in Sec. 424.535(a)(3), a State license suspension or revocation, or the practice location is determined by CMS or our contractor not to be operational, we do not believe that an expedited reconsideration process is warranted.

Comment: One commenter stated that our proposal to make revocation effective with limited notice and appeal rights in certain situations is a violation of due process.

Response: While we agree that physicians, NPPs and physician and

NPP organizations will receive limited notice when CMS or our contractor revokes Medicare billing privileges due to State licensure suspension/revocation, Federal debarment or exclusion, felony convictions as described in Sec. 424.535(a)(3), or when a practice location is found to no longer to be in operation, we disagree with this commenter's statement that we are violating due process rights.

Physicians, NPPs, and physician and NPP organizations are afforded identical appeal rights as any other provider or supplier whose

Medicare billing privileges were revoked.

Comment: One commenter stated that retroactive revocation creates a situation where Medicare denies payment for services physicians have furnished in good faith reduces the time available for appeal and then locks the physician out of Medicare for at least a year.

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Response: We disagree with this commenter. Whenever a physician or

NPP's State medical license is suspended or revoked, is convicted of felony as described in Sec. 424.535(a)(3), excluded or debarred from participating the Federal exclusion or debarment, or is determined by

CMS or our contractor not to be operational, we believe that the payments to these practitioners should immediately cease.

Comment: One commenter suggested, at the very least, current rights of appeal should be preserved for all proposed denials and we should actively research the performance of its contractors in auditing clinicians who make ``all or substantially all of their clinical encounters in the patient's home,'' and give provider feedback a defined role in the evaluation and subsequent award of contracts to intermediaries.

Response: This comment is outside the scope of this proposed rule and can not be addressed in this final rule.

After reviewing public comments, we are finalizing Sec. 405.874(b)(2) to state ``The revocation of a provider's or supplier's billing privileges is effective 30 days after CMS or the CMS contractor mails notice of its determination to the provider or supplier, except if the revocation is based on Federal exclusion or debarment, felony conviction as described in Sec. 424.535(a)(3), license suspension or revocation, or the practice location is determined by CMS or its contractor not to be operational. When a revocation is based on a

``Revocation becomes effective 30 days after CMS or the CMS contractor mails notice of its determination to the provider or supplier, except if the revocation is based on Federal exclusion or debarment, felony conviction, license suspension or revocations, or if the practice location is determined by CMS or its contractor not to be operational.

When a revocation is based on a Federal exclusion or debarment, felony conviction, license suspension or revocation, or the practice location is determined by CMS or its contractor not to be operational, the revocation is effective with the date of exclusion or debarment, felony conviction, license suspension or revocation or the date that CMS or its contractor determined that the provider or supplier was no longer operational.''

We continue to believe that revocations such as felony convictions and license suspensions or revocations are determinations that do not lend themselves to a corrective action plan and that the revocation should be effective with the date of the felony conviction or the license suspension or revocation action. Moreover, we maintain that when CMS or our contractor determines that a provider or supplier, including a DMEPOS supplier, is no longer operating at the practice location provided to Medicare on a paper or electronic Medicare enrollment application that the revocation should be effective with the date that CMS or our contractor determines that the provider or supplier is no longer operating at the practice location.

Further, while we do not believe that revocations based on felony convictions, license suspension or revocations, or a revocation based on a provider or a supplier no longer being operational at a specific practice location, lend themselves to a corrective action plan, we believe that these providers and suppliers should be afforded appeal rights in 42 CFR part 498. We believe that the appeals process will permit a provider or supplier who believes that CMS or our contractor has made an incorrect decision regarding revocation based on Federal exclusion or debarment, felony conviction, license suspension or revocation, or when we have determined that the provider or supplier is no longer operating at the practice location the opportunity to have

CMS or our contractor reconsider its initial revocation determination except for those revocation determinations imposed under Sec. 424.535(a)(2), (a)(3), and (a)(5). 6. Physician Resource Use Feedback Program a. General Background

CMS' Office of the Actuary estimates that the Medicare PFS allowed charges have grown approximately 55 percent from 2000 to 2007.\1\ The

Medicare Payment Advisory Commission (MedPAC) reports that since 2000, total Medicare spending for physicians' services has climbed more than 9 percent per year.\2\ In addition to these rapid increases in cost, the Dartmouth Atlas (http://www.dartmouthatlas.org/) shows that there is significant geographic variation in the amount of services Medicare beneficiaries receive, with little or no relationship to outcomes.\2\

We are implementing value-based purchasing (VBP) initiatives in response to these concerning trends. VBP ties payment to performance through the use of incentives based on measures of quality and cost of care. The implementation of VBP will transform CMS from a passive payer of claims to an active purchaser of higher quality, more efficient health care for Medicare beneficiaries. Our VBP initiatives include hospital pay for reporting (the Reporting Hospital Quality Data for the

Annual Payment Update program), physician pay for reporting (the

Quality Incentive Demonstration and the Physician Group Practice

Demonstration.

\1\ CMS Office of the Actuary.

\2\ Assessing Alternatives to the Sustainable Growth Rate

System. Medicare Payment Advisory Commission Report to Congress.

March 2007. http://www.medpac.gov/documents/Mar07_SGR_mandated_ report.pdf.

In its March 2005 Report to Congress, MedPAC recommended that CMS use Medicare claims data to measure physicians' resource use and share the results confidentially with physicians to educate them about how their resource use compares with aggregated peer performance. MedPAC envisioned that resource use measurement and feedback could encourage physicians to reduce the volume and intensity of the services they provide without sacrificing quality of care, thereby improving efficiency.\3\

\3\ Medicare Payment Policy. Medicare Payment Advisory

Commission Report to Congress. March 2005. Chapter 3. http:// www.medpac.gov/documents/Mar05_EntireReport.pdf.

In response to this MedPAC recommendation, we launched a study to develop resource use reports (RURs), in early 2006, with an initial focus on high cost imaging services. In Stage I of this study, we developed RURs for physician referral and utilization patterns for echocardiograms, along with a concentration on echocardiograms for patients with congestive heart failure. We worked with two healthcare systems in

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Madison, WI and Cleveland, OH to recruit physicians for the study. We used Medicare fee-for-service (FFS) claims data for the recruited physicians to populate RURs. Based on the feedback received during stage I, we redesigned the RURs (stage II) and focused on magnetic resonance imaging and computerized tomography imaging. For stage II, the RURs were modified to incorporate clinical guidelines into the reports. The construct of the RURs included in stages I and II of the study is similar to the RURs that are described, in detail, in section 6.c. of this final rule.

Building on its March 2005 recommendation, MedPAC subsequently released an additional report on the topic of measuring physician resource use. In its June 2006 Report to Congress, MedPAC focused on commercial episode grouper products. In that report, MedPAC addressed such issues as: risk adjustment, attribution (assignment) of cost per episode to individual physicians, and variation in resource use across geographic areas. MedPAC tested two commercially available episode grouper products, Episode Treatment Groups (ETGs) and Medical Episode

Groups (MEGs), using Medicare fee-for-service claims data.\4\ The ETG product is owned by Ingenix and ``identifies and classifies an entire episode of care regardless of whether the patient has received medical treatment as an outpatient, inpatient, or both.'' \5\ The MEG product is owned by Thomson and ``groups inpatient, outpatient, and pharmaceutical claims into clinically homogenous units of analysis called episodes that describe a patient's complete course of care for a single illness or condition.'' \6\

\4\ Increasing the Value of Medicare. Medicare Payment Advisory

Commission Report to Congress. June 2006. Chapter 1. http:// www.medpac.gov/documents/Jun06_EntireReport.pdf.

\5\ Ingenix Product Sheet. http://www.ingenix.com/content/ attachments/ETG_ProductSheet.pdf.

\6\ Thomson Product Sheet. http://home.thomsonhealthcare.com/ uploadedFiles/docs/MEG_HP_TH10002.pdf.

In 2006, we awarded a contract to Acumen LLC, to explore how the

ETGs and MEGs handle Medicare FFS claims data. In addition to Acumen's technical episode grouper analysis, we are also pursuing a contract with Kennell, LLC to analyze selected claims grouping algorithms within each of these commercial episode grouper products. Both of these research contracts are currently underway.

The Government Accountability Office (GAO) has also addressed physician resource use. In their April 2007 report, GAO compared the resource use of physician practices with that of their peers and specifically focused on outliers. In their report, GAO recommended that

CMS develop a system to identify physicians with inefficient practice patterns and provide confidential feedback to improve efficiency.\7\

\7\ Focus on Physician Practice Patterns Can Lead to Greater

Program Efficiency. April 2007. http://www.gao.gov/new.items/ d07307.pdf.

A number of other entities have also been developing approaches to measuring and reporting on physician resource use, including the

National Quality Forum, the National Committee for Quality Assurance, the Quality Alliance Steering Committee, and the AQA-Alliance. b. Statutory Authority

Section 131(c) of the MIPPA amends section 1848 of the Act by adding subsection (n), which requires the Secretary to establish and implement by January 1, 2009, a Physician Feedback Program using

Medicare claims data and other data to provide confidential feedback reports to physicians (and as determined appropriate by the Secretary, to groups of physicians) that measure the resources involved in furnishing care to Medicare beneficiaries. If determined appropriate by the Secretary, the Secretary may also include information on quality of care furnished to Medicare beneficiaries by the physician (or group of physicians) in the reports. We have titled this initiative the physician resource use feedback program.

Under section 1848(n)(1)(B) of the Act, resource use may be measured on an: (i) Episode basis, (ii) per capita basis, or (iii) on both an episode and a per capita basis. In addition, to the extent practicable, data for reports shall be based on the most recent data available. Section 1848(n)(4) authorizes the Secretary to focus the application of the program as appropriate, such as focusing the program on: (1) Physician specialties that account for a certain percentage of all spending for physicians' services; (2) physicians who treat conditions that have a high cost, of a high volume, or both; (3) physicians who use a high amount of resources compared to other physicians; (4) physicians practicing in certain geographic areas; or

(5) physicians who treat a minimum number of individuals. In addition, section 1848(n)(5) authorizes the Secretary to exclude certain information regarding a service from a report with respect to a physician (or group of physicians) if the Secretary determines that there is insufficient information relating to that service to provide a valid report on that service. Finally, under section 1848(n)(6), to the extent practicable, the Secretary shall make appropriate adjustments to the data used to prepare RURs, such as adjustments to take into account variations in health status and other patient characteristics. c. Implementation of Section 1848(n)(1)(B)

In April 2008, we awarded a contract to Mathematica Policy Research to assist in the development of physician resource use measures and confidential feedback reports. The purposes of the contract were to:

(1) Develop meaningful, actionable, and fair measures of resource use for physician practices with the ultimate goal of using the measures in

CMS' VBP initiatives; and (2) provide feedback and education to encourage more efficient provision of services. The Mathematica contract contains the following tasks: (1) Development of resource use measures based on both an episode of care (ETG & MEG) and per capita analysis; (2) risk adjustment of Medicare FFS claims data for patient severity of illness; (3) development of methodologies to attribute both episodes and total cost of care for a beneficiary to individual physicians and multiple physicians; (4) development of benchmarks for peer comparison; (5) populate RURs with Medicare FFS data for several medical specialties; (6) recruit physicians to confidentially share the feedback reports; and (7) submit all documentation and production programming logic to allow for a possible national dissemination of

RURs to physicians. The work performed and derived from this contract is the basis for establishing the program required under section 1848(n) of the Act, which we will refer to as the ``Physician Resource

Use Feedback Program.''

The Physician Resource Use Feedback Program will consist of multiple phases. Under this approach, each phase of the program will inform future phases of the Program. The tasks listed above comprise phase I of the feedback program. To date, CMS has disseminated RURs in two program sites: Baltimore, MD (August 2008) and Boston, MA

(September 2008). Baltimore was selected as a program site due to its close proximity to the CMS central office and Boston was selected as a program site due to its high per capita Medicare costs and utilization

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rates.\8\ We refer readers to a detailed discussion of the Baltimore and Boston program sites below. Any additional Phase I activities completed for the Physician Resource Use Feedback Program will be similar to activities completed in Baltimore and Boston, including the same methodologies for: (1) Choosing additional program sites, (2) recruitment of physicians, and (3) construction of RURs. We are implementing Phase I of the Physician Resource Use Feedback Program on an interim final basis with comment period and it is CMS' intent to propose subsequent phases of the program through rulemaking.

\8\ Dartmouth Atlas of Healthcare. 2005 Medicare reimbursement figures derived from Hospital Service Area (HSA).

As indicated above, section 1848(n)(1)(B) of the Act requires that the physician resource feedback program address resources measured on:

(1) An episode basis; (2) a per capita basis; or (3) both an episode and a per capita basis. The RURs used in the Baltimore program site used a per capita analysis for measuring cost of care and the RURs used in the Boston program site used both a per capita and an episode of care analysis for measuring cost of care. Accordingly, we are implementing this approach to resource measurement on an interim final basis and solicit comments on this approach, as well as the following additional questions:

Are per capita resource use measures meaningful and actionable?

Are episode-based resource use measures meaningful and actionable?

Are composite measures of resource use that combine episodes of care valuable?

We also provided the Baltimore and Boston physicians with a cost of service category breakdown (for example, imaging services, inpatient admissions, or outpatient services) for both the per capita and episode of care analyses. We are finalizing this approach and welcome public comment on including cost of service categories to capture Medicare FFS claims data, as well as other ways to capture data in the Physician

Resource Use Feedback Program. In particular, we are soliciting comment on the following:

What cost of service categories are most meaningful and actionable?

Section 1848(n)(3) of the Act, requires that, to the extent practicable, the data for the reports shall be based on the most recent data available. In Phase I of the Physician Resource Use Feedback

Program, we are using Medicare FFS claims data from 2004-2007, which is currently the most recent data available. The per capita analysis used in both Baltimore and Boston included Medicare FFS claims data for calendar year 2005. The episode of care analysis used in Boston included Medicare FFS claims data for calendar years 2004-2006.

Typically, when an episode of care analysis is used, one calendar year of data is used as a focal year (in this case 2005) and the prior year

(2004) and following year (2006) are also included to ensure the episode captures any services that may occur just outside of a calendar year. We are implementing and soliciting comment on this approach to data for Phase I, as well as seeking comments on the following:

How many years of data should be included for a per capita analysis?

How many years of data should be included for an episode of care analysis?

As explained above, under section 1848(n)(4) of the Act, the

Secretary may focus the application of the program as appropriate, including focusing on physicians who treat conditions that are high cost, a high volume, or both. CMS has identified several priority conditions that are high cost, high volume, or both through an analysis of Medicare FFS claims data. The reports disseminated in the Baltimore and Boston program sites included the following conditions: (i) congestive heart failure; (ii) chronic obstructive pulmonary disorder;

(iii) prostate cancer; (iv) cholecystitis; (v) coronary artery disease with acute myocardial infarction flare-up; (vi) hip fracture; (vii) community-acquired pneumonia; and (viii) urinary tract infections.

Under section 1848(n)(4) of the Act, we also are permitted to focus the application as appropriate on physician specialties that account for a certain percentage of all spending for physicians' services.

Based upon the high cost and high volume conditions selected above, CMS identified the several medical specialties as being the most relevant specialties for treating those conditions. The RURs disseminated in the

Baltimore and Boston program sites included the following physician specialties: internal medicine, cardiology, gastroenterology, general practice, orthopedic surgery, medical oncology, urology, pulmonology, family practice, and primary care. We are implementing the focus of

Phase I of the Program on the above conditions and medical specialties on an interim final basis and we welcome public comments on the selected conditions and medical specialties, as well as any additional conditions and medical specialties to include in the feedback program.

To select physicians, CMS recruited participants for the Baltimore and Boston program sites based on self-designated medical specialty.

Both the Baltimore and Boston sites included physicians from all of the medical specialties listed above. Once physicians agreed to participate in the Baltimore and Boston program sessions, CMS used Medicare physician identifiers to find Medicare FFS claims data to populate individual physician RURs for the participating physicians.

Approximately 50 physicians participated in a 60-minute individual in- depth session with one interviewer that covered approximately 4 different RUR designs. Each one-on-one physician/interviewer session educated the physician on his/her individual Medicare FFS resource utilization. In the cases where Medicare FFS data was available, a de- identified report of real data was used for educational purposes. The

RURs contained all of the elements discussed throughout section 6.c of this final rule. In particular, we are soliciting public comments on the following:

Do physicians prefer paper or electronic feedback reports?

How do physicians prefer to provide comments on or ask questions about the RURs?

What other types of the outreach/educational efforts are useful in helping physicians understand resource use?

As mentioned previously, section 1848(n)(4) of the Act permits us to focus the program as appropriate, such as focusing the program on physicians practicing in certain geographic areas. The RURs disseminated in Baltimore included a geographic benchmark for all physicians treating one condition (listed above) in the Baltimore-

Washington, DC metro area, as defined by zip codes. The Baltimore program site also used hospital service area (HSA) as a geographic benchmark. The HSA was based upon all hospitals in the Baltimore-

Washington, DC metro area that physicians typically refer beneficiaries to for a particular condition. The Boston program site also used the

HSA benchmark and used the state of Massachusetts as a benchmark. We welcome public comment on the selected geographic benchmarks implemented for those areas, as well as any additional geographic benchmarks that could be included in the Physician Resource Use

Feedback Program.

Section 1848(n)(4) of the Act also permits us to focus the program as appropriate, such as on physicians who use a high amount of resources compared to other physicians. The RURs disseminated in

Baltimore and Boston contained distribution curves

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that defined peer groups of physicians for one condition using the specialty and geographic benchmarks mentioned above. Within each peer group, a physician was identified as a high cost outlier if he/she fell within the 90th percentile of cost or higher. In addition, to including a high cost benchmark, the Baltimore and Boston RURs included a low cost (10th percentile) benchmark and a median cost (50th percentile) benchmark. We are implementing this approach and welcome public comment on the cost benchmarks, as well as any additional cost benchmarks that could be included in the program. Further, we are soliciting public comment on which benchmarks (specialty, geography, and cost) are most likely to motivate changes in resource use.

In order to identify a high cost outlier, attribution of cost must be assigned to a physician. In the Baltimore and Boston program sessions, CMS provided RURs that contained several different methodologies for attribution or assignment of costs to physicians. The following five attribution rules were included: (i) Physician billing the most Evaluation and Management (E&M) visits and billing for at least 10 percent of the total cost for a beneficiary or an episode of care; (ii) physician billing the most established E&M visits (chronic conditions only); (iii) assign all cost to each physician billing for any E&M or procedure; (iv) assign cost to each physician in proportion to billed visits; and (v) assign cost to the physician billing the first E&M visit (acute episodes only). In our continued distribution of

RURs through phase I, we will continue to update and refine our attribution rules. We are soliciting comments on this approach and the following:

What criteria should be taken into account to ensure equity when considering attribution rules?

Finally, although the statute authorizes the Secretary to focus the application of the program as appropriate, on physicians who treat a minimum number of individuals and authorizes us to provide feedback to groups of physicians, as determined appropriate by the Secretary, we did not exercise these optional provisions in the Baltimore and Boston program sites and are not finalizing these in Phase I of the program.

In addition, section 1848(n)(6) of the Act also requires that adjustments, to the extent practicable, take into account variations in health status and other patient characteristics. This type of adjustment was not practicable due to the complexity of risk adjustment tasks, coupled with the short implementation time from passage of MIPPA legislation to the start date of the Baltimore and Boston program sites. We welcome public comment on factors to consider for establishing minimum thresholds, risk adjustment methodologies, and measuring group practice level resource use.

III. Medicare Improvements for Patients and Providers Act of 2008

(MIPPA) Provisions

The following section addresses certain provisions of the Medicare

Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275). Except as noted otherwise within this final rule with comment period, we consider these provisions to be self-implementing. We are revising our policies and regulations as described below in order to conform then to the statutory amendments.

A. Section 101: Improvements to Coverage of Preventive Services 1. Improvements to Coverage of Preventive Services

Over the past 25 years, the Congress has added specific preventive and screening services to the voluntary Part B program. Most of the preventive or screening services that are already covered under

Medicare are described in 42 CFR part 410, subpart B, and also as exceptions to statutory exclusions in Sec. 411.15. These preventive and screening services include the following:

Pneumococcal, influenza, and hepatitis B vaccinations

(Sec. 410.57 and Sec. 410.63);

Pap smear (section 1861(nn) of the Act);

Screening mammography (Sec. 410.34);

Colorectal cancer screening tests (Sec. 410.37);

Screening pelvic exams (Sec. 410.56);

Prostate cancer screening tests (Sec. 410.39);

Glaucoma screening exams (Sec. 410.23);

Ultrasound screening for abdominal aortic aneurysms (AAA)

(Sec. 410.19);

Cardiovascular disease screening tests (Sec. 410.17);

Diabetes screening tests (Sec. 410.18); and

The initial preventive physical examination (IPPE) (Sec. 410.16).

Section 101(a) of the MIPPA provides for coverage under Part B of

``additional preventive services'', which are determined to meet certain requirements, effective for services furnished on or after

January 1, 2009. Section 101(a) of the MIPPA provides the Secretary with the authority to add coverage of ``additional preventive services'', and specifies the process and the criteria that are to be used in making determinations regarding the coverage of such services under the Part B program. As provided in the law, this new coverage allows payment for ``additional preventive services'' not otherwise described in Title XVIII of the Act, if the Secretary determines through the national coverage determination (NCD) process (as defined in section 1869(f)(1)(B) of the Act) that the new services meet statutory requirements for coverage.

Specifically, section 101(a) of the MIPPA defines ``additional preventive services,'' as services not otherwise described in title

XVIII that identify medical conditions or risk factors and that the

Secretary determines are--

(1) Reasonable and necessary for the prevention or early detection of an illness or disability;

(2) Recommended with a grade of A or B by the United States

Preventive Services Task Force; and

(3) Appropriate for individuals entitled to benefits under Part A or enrolled under Part B.

The U.S. Preventive Services Task Force (USPSTF) is an independent panel of experts in primary care and prevention that systematically reviews the evidence of effectiveness and develops recommendations for clinical preventive services, under the sponsorship of HHS' Agency for

Healthcare Research and Quality (AHRQ). The USPSTF grades the strength of the evidence from ``A'' (strongly recommends), ``B'' (recommends),

``C'' (no recommendation for or against), ``D'' (recommends against), or ``I'' (insufficient evidence to recommend for or against).

In addition, section 101(a) provides that in making national coverage determinations (NCDs) for the coverage of a new service, the

Secretary ``may conduct an assessment of the relation between predicted outcomes and the expenditures for such service and may take into account the results of such assessment in making such determination.''

We plan to evaluate the preventive services not otherwise described in title XVIII of the Act and that have been recommended with a grade A or B by the USPSTF and determine whether to open an NCD on one or more of them. USPSTF currently has 15 to 20 preventive services with a Grade

A or B recommendation that may be appropriate for the Medicare population. These services can be found on its Web site at http://

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www.preventiveservices.ahrq.gov. We may exclude reviewing any one of these services if: (1) There is an existing Medicare screening or preventive benefit for that particular service; (2) the service does not appear to be appropriate for the Medicare population (for example, pediatric services). We invite public requests on the services on the

USPSTF list that CMS should consider for an NCD using the procedures described at http://www.cms.hhs.gov/DeterminationProces/02_ howtorequestanNCD.asp.

The NCD process consists of three major steps: (1) Initiation; (2) review; and (3) completion. We initiate the NCD process by ``opening'' the NCD. This is announced to the public by posting a ``tracking sheet'' on the CMS Coverage Web site with an initial 30-day public comment period. The public will have another opportunity to comment on the NCD when the proposed decision is published. After taking into consideration all of the public comments and evidence, a final decision will be made public. Development of a complete, formal request for an

NCD can be initiated either by an outside party or internally by CMS staff.

We are establishing new Sec. 410.64, Additional Preventive

Services, to reflect these statutory requirements. To conform the regulations to the statutory requirements of the MIPPA, we are also adding new paragraph Sec. 411.15(k)(15) for ``additional preventive services.''

Payment of Co-Insurance

Section 101(a)(2) of the MIPPA establishes payment rules under Part

B if the Secretary makes a NCD for an additional preventive service under section 1861(ddd) of the Act. The amount of the Part B payment and the amount of the beneficiary's Part B coinsurance will depend on the nature of the new preventive service. For instance, if the additional preventive service is a clinical diagnostic laboratory test,

Medicare pays on a fee schedule basis and the amount paid is 100 percent. There is no beneficiary coinsurance. For all other additional preventive services, Medicare will pay 80 percent of the lesser of the actual charge for the service or the amount of the fee schedule. The beneficiary would be responsible for the remaining 20 percent as coinsurance. We will specifically identify the type of service and the accompanying payment levels in our implementing instructions that will be issued contemporaneously with each NCD. 2. Revisions to Initial Preventive Physical Examination (IPPE)

Section 101(b) of the MIPPA also amended section 1861(ww)(1) of the

Act which establishes an IPPE for individuals who are newly enrolled in the voluntary Part B program. This benefit was originally effective on

January 1, 2005, and is implemented at Sec. 410.16. Section 101(b) of the MIPPA revises the benefit by the following:

(1) Adding the measurement of an individual's body mass index as part of the IPPE;

(2) Upon the individual's consent, adding end-of-life planning to the IPPE services; and

(3) Removing the electrocardiogram from the list of mandated services that must be included in the IPPE benefit, and making it an educational, counseling, and referral service to be discussed with the individual and ordered by the physician, if necessary.

Section 101(b) of the MIPPA also amended section 1861(ww)(1) of the

Act by defining the term ``end-of-life planning'' to mean verbal or written information regarding (1) an individual's ability to prepare an advance directive in the case that an injury or illness causes the individual to be unable to make health care decisions, and (2) whether or not the physician is willing to follow the individual's wishes as expressed in an advance directive.

We are amending Sec. 410.16(a)(4) (the physical exam element) of the IPPE benefit so that it includes the measurement of an individual's body mass index. We are amending Sec. 410.16(a)(5) to omit the electrocardiogram as a mandatory part of the IPPE benefit, and add the electrocardiogram to the list of education, counseling, and referral services described in Sec. 410.16(a)(7) of the IPPE benefit.

We are also amending Sec. 410.16(a)(5) by inserting in the place of the term ``electrocardiogram'' the language ``end-of-life planning'' and noting the need for the consent of the individual to have this discussion.

We are also amending Sec. 410.16(a) of the IPPE benefit by adding a definition of the term ``end-of-life planning'' to reflect the statutory definition of that term as described above.

Section 101(b) of the MIPPA also amended section 1861(ww)(1) of the

Act (the IPPE benefit) by adding the ``additional preventive services'' benefit to the list of screening and preventive services for which physicians and other qualified nonphysician practitioners must provide

``education, counseling and referral.'' The Congress also extended the time period that newly eligible Part B beneficiaries can obtain the

IPPE benefit from 6 months to the first 12 months after the effective date of their first Part B coverage period. Therefore, we are amending

Sec. 410.16(a)(7) to reflect the additional education, counseling and referral responsibilities that physicians and other practitioners will have under the IPPE benefit for the electrocardiogram and the

``additional preventive services'' that may be covered in the future.

As mentioned above, the Congress extended the eligibility period for beneficiaries from 6 months to 1 year as provided in section 1862(a)(1)(K) of the Act. This statute is effective for services furnished on or after January 1, 2009. We are revising the present definition of the term ``eligible beneficiary'' in Sec. 410.16(a) to read as follows: ``Eligible beneficiary'' means an individual who receives his or her IPPE not more than 1 year after the effective date of his or her first Medicare Part B coverage period. 3. Payment for IPPE

In order to implement section 101(b) of the MIPPA, beginning

January 1, 2009, we will pay for an IPPE performed not later than 12 months after the date of the beneficiary's initial enrollment in

Medicare Part B. We will pay for one IPPE per beneficiary per lifetime.

The Medicare deductible does not apply to the IPPE if performed on or after January 1, 2009.

The section 101(b) of the MIPPA also removes the screening electrocardiogram (EKG) as a mandatory requirement as identified in section 1861(ww)(1) of the Act as part of the IPPE. The MIPPA requires that there be education, counseling, and referral for an EKG, as appropriate, for a once-in-a lifetime screening EKG performed as a result of a referral from an IPPE as stated in revised Sec. 410.16.

Effective for beneficiaries who receive the IPPE on or after January 1, 2009, the screening EKG will be billable with G code(s) when it is a result of a referral from an IPPE. Billing instructions for physicians, qualified NPPs, and providers will be issued.

We are implementing the following G codes to identify these services:

G0402: Initial preventive physical examination; face-to- face visit, services limited to new beneficiary during the first 12 months of Medicare enrollment.

G0403: Electrocardiogram, routine ECG with at least 12 leads; performed as a screening for the initial preventive physical examination with interpretation and report.

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G0404: Electrocardiogram, routine ECG with at least 12 leads; tracing only, without interpretation and report, performed as a screening for the initial preventive physical examination.

G0405: Electrocardiogram, routine ECG with at least 12 leads; interpretation and report only, performed as a screening for the initial preventive physical examination.

The 4 existing G codes (G0344, G0366, G0367, and G0367) will be active until December 31, 2008, for beneficiaries who have the IPPE prior to January 1, 2009.

Work RVUs: We believe the additional work of performing a measurement of an individual's body mass index and, upon consent of an individual, the discussion of end-of-life planning, as described in the coverage section, represent minimal work. A simple tool is used to determine body fat based on an individual's height and weight that applies to both adult men and women. End-of-life planning as previously described is verbal or written information given to the beneficiary regarding advance directive preparation and a discussion regarding whether the physician is willing to follow an individual's wishes made in an advance directive.

Therefore, for CY 2009, we are retaining the current work RVUs for the new IPPE G code (G0402) which involves equivalent resources and work intensity to those services contained in CPT evaluation and management (E/M) code 99203, new patient, office or other outpatient visit. However, we are interested in receiving comments on suggested valuations of this service to reflect the resources required. We will also retain the work RVUs for the new EKG G codes which are equivalent to those for CPT codes 93000, 93005 and 93010. In addition, we note that the policy for reporting a medically necessary E/M service furnished at the same IPPE visit will still apply. CPT codes 99201 through 99215 may be used depending on the circumstances and appended with CPT modifier ``25'' identifying the E/M visit as a significant, separately identifiable service from the IPPE code G0402.

We do not believe this scenario will be the typical occurrence and we will monitor utilization patterns involving the level 4/5 new or established office or other outpatient visit codes being reported with the IPPE. If there are consistent data that demonstrate high usage of level 4/5 E/M codes in conjunction with the IPPE, we will reevaluate the policy.

Additionally, since section 101(b) of the MIPPA provides that the

Medicare Part B deductible will not apply for the IPPE performed on or after January 1, 2009 (as defined in section 1861(ww)(1) of the Act), we are revising Sec. 410.160(b) to include an exception from the

Medicare Part B deductible for the IPPE as described in Sec. 410.16

(Initial preventive physical examination: Conditions for and limitations on coverage). The co-insurance continues to apply.

B. Section 131: Physician Payment, Efficiency, and Quality Improvements

Section 131 of the MIPPA includes a number of provisions that impact the quality reporting system defined in section 1848(k) of the

Act. For ease of reference, we have named this quality reporting system, the ``Physician Quality Reporting Initiative'' (PQRI). Although the new MIPPA amendments that pertain to the PQRI, including those provisions that pertain to PQRI beyond 2009, are generally described below, the scope of this final rule with comment period is limited to the 2009 PQRI. The 2009 PQRI, including our implementation of the new

MIPPA amendments as they pertain to the 2009 PQRI, is discussed in detail in section II.O1. of this final rule with comment period. This final rule with comment period does not address nor does it attempt to implement any of the new MIPPA amendments as they pertain to the PQRI in 2010 and beyond. The new MIPPA amendments as they pertain to the

PQRI in 2010 and beyond will be addressed through future notice and comment rulemaking.

Section 131(b)(1) of the MIPPA amends section 1848(k)(2) of the Act to add new paragraph (C), which provides that for the purposes of reporting quality measures for covered professional services furnished during 2010 and subsequent years for the PQRI, the quality measures

(including electronic prescribing measures) shall be such measures selected by the Secretary from measures that have been endorsed by the entity with a contract with the Secretary under subsection 1890(a) as added by the MIPPA. Section 1848(k)(2)(C) of the Act also provides that for the 2010 and future years of the PQRI, in the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by the entity with a contract under subsection 1890(a), as added by the MIPAA, the

Secretary may specify a measure that is not so endorsed as long as due consideration is given to measures that have been endorsed or adopted by a consensus organization identified by the Secretary, such as the

AQA-Alliance.

Paragraph (D) of section 1848(k)(2) of the Act, as added by section 131(b)(1) of the MIPPA, requires that for each quality measure

(including an electronic prescribing quality measure) adopted by the

Secretary for the PQRI in 2009 and subsequent years, the Secretary shall ensure that eligible professionals have the opportunity to provide input during the development, endorsement, or selection of measures applicable to the services they furnish. Additional discussion of the requirements of section 1848(k)(2)(D) of the Act as they pertain to the 2009 PQRI can be found in section II.O1. of this final rule with comment period.

Section 131(b)(2) of the MIPPA redesignates section 101(c) of the

MIEA-TRHCA, as amended by the MMSEA, as subsection (m) of the Act.

Section 1848(m)(1) of the Act authorizes the Secretary to make incentive payments for satisfactorily reporting data on quality measures for covered professional services furnished by eligible professionals during the reporting period for the PQRI in 2007 through 2010. In addition to the 1.5 percent incentive payment already authorized for the 2007 and 2008 PQRI, section 1848(m)(1)(B) of the

Act, as redesignated by section 131(b)(2) of the MIPPA and amended by section 131(b)(3)(B) of the MIPPA, authorizes the Secretary, for the 2009 and 2010 PQRI, to provide an incentive payment equal to 2.0 percent of the estimated total allowed charges submitted not later than 2 months after the end of the reporting period for all covered professional services furnished during the reporting period for 2009 and 2010, respectively.

Section 1848(m)(3)(A) of the Act, as redesignated by section 131(b)(3)(C) of the MIPPA and amended by section 131(b)(3)(D)(iii) of the MIPPA, specifies that for 2009 and subsequent years, the PQRI quality measures shall not include electronic prescribing measures.

Therefore, as discussed further in section II.O1. of this final rule with comment period, we are not including measure 125, Health

Information Technology: Adoption/Use of Medication e-Prescribing, in the final set of 2009 PQRI quality measures.

Section 1848(m)(3)(C) of the Act, as added by section 131(b)(3)(D)(iv) of the MIPPA, requires that ``by January 1, 2010, the

Secretary shall establish and have in place a process under which eligible professionals in a group practice (as defined by the

Secretary) shall be treated as satisfactorily submitting data on quality measures'' for the PQRI ``if,

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in lieu of reporting measures under section 1848(k)(2)(C) of the Act the group practice reports measures determined appropriate by the

Secretary, such as measures that target high-cost chronic conditions and preventive care, in a form and manner, and at a time, specified by the Secretary.'' Section 1848(m)(3)(C) of the Act also provides for the use of a statistical sampling model to submit data on measures, such as the model used under the Physician Group Practice demonstration project, and provides that incentive payments made to a group practice for satisfactorily submitting data on quality measures for the PQRI shall be made in lieu of the incentive payments that would otherwise be made to eligible professionals in the group practice for satisfactorily submitting data on quality measures. The requirements at section 1848(m)(3)(c) of the Act also apply to successful electronic prescribers (as defined in section 1848(m)(B)(ii) of the Act), which are described generally in section III.D. and in detail in section

II.O2. of this final rule with comment period.

Section 1848(m)(3)(D) of the Act, as added by section 131(b)(3)(D)(iv) of the MIPPA, authorizes the Secretary, in consultation with stakeholders and experts, to revise the criteria for satisfactorily reporting data on quality measures for the PQRI and for submitting data on electronic prescribing quality measures for years after 2009.

Section 1848(m)(5)(D)(iii) of the Act, as redesignated by section 131(b)(2) of the MIPPA and amended by section 131(b)(3)(E) of the

MIPPA, provides that if the Secretary has determined an eligible professional (or group practice) has not reported measures applicable to covered professional services of such professional (or group practice), the Secretary shall not pay the incentive payment, and that if an incentive payment has already been made to an eligible professional (or group practice), the Secretary shall recoup such payments from the eligible professional (or group practice).

Subparagraph (G) of section 1848(m)(5) of the Act, as added by section 131(b)(3)(E)(v) of the MIPPA, requires the Secretary to post on the CMS Web site, in an easily understandable format, a list of the names of: (1) The eligible professionals (or group practices) who satisfactorily submitted data on quality measures for the PQRI; and (2) the eligible professionals (or group practices) who are successful electronic prescribers.

Section 1848(m)(6)(C) of the Act, as redesignated by section 131(b)(2) of the MIPPA and amended by section 131(b)(3)(F) of the

MIPPA, defines ``reporting period'' for the 2008 through 2011 PQRI to be the entire year and authorizes the Secretary to revise the reporting period for years after 2009 if the Secretary determines such ``revision is appropriate, produces valid results on measures reported, and is consistent with the goals of maximizing scientific validity and reducing administrative burden.''

Section 131(b)(4) of the MIPPA amends section 1848(k)(3)(B) of the

Act to include a qualified audiologist (as defined in section 1861(ll)(3)(B) of the Act) in the definition of an ``eligible professional'' beginning with the 2009 PQRI.

Section 131(b)(6) of the MIPPA provides that none of the amendments made by subsection 131(b) or section 132 of the MIPPA shall affect the operation of the provisions of section 1848(m) of the Act, with regard to 2007 or 2008.

Further discussion of these MIPPA provisions as they relate to the 2009 PQRI can be found in section II.O1. of this final rule with comment period.

In addition to the provisions that impact the PQRI, section 131(a) of the MIPPA amended section 1848(d)(8) of the Act to extend the 6- month increase in the CY 2008 CF to the entire year and added section 1848(d)(9) of the Act which provided that the update to the single CF for CY 2009 shall be 1.1 percent. This subsection further specified that the CFs for CY 2010 and subsequent years must be computed as if these increases had never applied. Further discussion of these MIPPA provisions as they relate to the PFS update and CF for 2009 can be found in sections VII. and IX. of this final rule with comment period.

C. Section 131(c): Physician Resource Use Feedback Program

Section 131(c) of the MIPPA amends section 1848 of the Act by adding subsection (n), which requires the Secretary to establish and implement by January 1, 2009, a Physician Feedback Program using

Medicare claims data and other data to provide confidential feedback reports to physicians (and as determined appropriate by the Secretary, to groups of physicians) that measure the resources involved in furnishing care to Medicare beneficiaries. If determined appropriate by the Secretary, the Secretary may also include information on quality of care furnished to Medicare beneficiaries by the physician (or group of physicians) in the reports. In addition, section 131(c) of the MIPPA outlines the general components and aspects of the program, but provides the Secretary broad discretion with regard to implementation and development of the program. Given the timing of the passage of

MIPPA and the deadline for implementing a program, we believe it would be contrary to the public interest to delay implementation and therefore, we will implement the physician feedback program on an interim final basis and provide opportunity for public comment. We refer readers to section II.S.6. of this final rule with comment period for a detailed discussion and implementation of section 131(c) of the

MIPPA.

D. Section 132: Incentives for Electronic Prescribing

Section 132(a)(1) of the MIPPA amends section 1848(m) of the Act, as redesignated by section 131(b)(2) of the MIPPA, to authorize for 2009 through 2013 incentives to eligible professionals or group practices who are ``successful electronic prescribers.'' For 2009 and 2010, the Secretary is authorized to provide successful electronic prescribers an incentive payment equal to 2.0 percent of the total estimated allowed charges submitted not later than 2 months after the end of the reporting period for all covered professional services furnished during the 2009 and 2010 reporting periods, respectively.

Reduced incentive payments apply to subsequent years through 2013.

Section 132(b) of the MIPAA amends section 1848(a) of the Act such that a payment differential applies to those who are not successful electronic prescribers starting in 2012. During 2012 or any subsequent year, if the eligible professional is not a successful electronic prescriber for the reporting period, the fee schedule amount for covered professional services furnished by such professional during the year shall be reduced by: 1.0 percent for 2012. 1.5 percent for 2013. 2.0 percent for 2014 and each subsequent year.

Section 132(a)(2) of the MIPPA amends section 1848(m)(3) of the

Act, as redesignated by section 131(b)(2) of the MIPPA, to authorize the Secretary to identify successful electronic prescribers for a reporting period using one of two possible standards: One based on the eligible professional's reporting, in at least 50 percent of the reportable cases, on any electronic prescribing quality measures that have been established under the physician reporting system under subsection

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1848(k) (which, as noted previously, we have named ``PQRI'' for ease of reference) and are applicable to services furnished during a reporting period, as amended by section 131(b) of the MIPPA, and one based on the electronic submission by the eligible professional of a sufficient number of prescriptions under the Medicare Prescription Drug Benefit

Program (Part D) during the reporting period. If the Secretary decides to use the latter standard, the Secretary is authorized to use Part D drug claims data to assess whether a ``sufficient'' number of prescriptions have been submitted by eligible professionals. We do not intend to use this latter standard for 2009. However, to the extent that we intend to use this latter standard in future years, we will address how we plan to define ``sufficient'' through notice and comment rulemaking. Section 1848(m)(3)(B) of the Act, as added by section 132(a)(2)(B) of the MIPPA, also requires that to the extent practicable, in determining whether eligible professions meet the requirements to be identified as successful electronic prescribers,

``the Secretary shall ensure that eligible professionals utilize electronic prescribing systems in compliance with standards established for such systems pursuant to the Part D Electronic Prescribing Program under section 1860D-4(e) of the Act.'' The 2009 electronic prescribing incentive reporting period and the criteria that will be used by CMS to identify successful electronic prescribers for 2009 are described in detail in section II.O2. of this final rule with comment period.

Section 132(a)(1) of the MIPPA also amends section 1848(m) of the

Act, as redesignated by section 131(b)(2) of the MIPPA, to provide for an exemption from both the incentive payment and the payment differential for a particular reporting period of certain eligible professionals. The Secretary is authorized to choose between two possible standards for the exemption: One based upon whether the allowed charges to which the electronic prescribing quality measure applies are less than 10 percent of the total allowed charges for all covered professional services furnished by the eligible professional during the reporting period; and one based on whether the eligible professional does not submit (including both electronically and nonelectronically) a sufficient number (as determined by the Secretary) of prescriptions under Part D (which can again be assessed using Part D drug claims data). We do not intend to use this latter standard for 2009. However, to the extent that we intend to use this latter standard in future years, we will address how we plan to define ``sufficient'' through notice and comment rulemaking. For 2009, the criteria for exemption from the incentive payments for electronic prescribing are described in section II.O2. of this final rule with comment period.

Section 132(b) of the MIPPA also amends section 1848(a) of the Act to authorize the Secretary to apply a hardship exception on a case-by- case basis to exempt eligible professionals from the payment differential that applies to those who are not successful electronic prescribers by 2012. Since this hardship exception does not apply until 2012, we will address the parameters that we intend to apply to determine hardship through future notice and comment rulemaking.

E. Section 133(b): Expanding Access to Primary Care Services

Section 1848(c)(2)(B)(ii)(II) of the Act requires that increases or decreases in RVUs for a year may not cause the amount of expenditures for the year to differ by more than $20 million from what expenditures would have been in the absence of these changes. If this threshold is exceeded, we must make adjustments to preserve BN.

The 5-Year Review of work RVUs would have resulted in a change in expenditures that would exceed $20 million if we made no offsetting adjustments to either the CF or RVUs. In CY 2007 and CY 2008, we met the 5-Year Review BN requirement by making a separate adjustment to the work RVUs.

Section 133(b) of the MIPPA amends section 1848(c)(2)(B) of the Act to specify that the BN adjustor for the 5-Year Review must be applied to the conversion factor beginning with CY 2009. Further discussion of this MIPPA provision as it relates to the CY 2009 PFS can be found in section IX. of this final rule with comment period.

F. Section 134: Extension of Floor on Medicare Work Geographic

Adjustment Under the Medicare Physician Fee Schedule

In accordance with section 103 of the MMSEA, the 1.000 work GPCI floor was set to expire as of July 1, 2008. Section 134(a) of the MIPPA extended the 1.000 work geographic practice cost index (GPCI) floor from July 1, 2008 through December 31, 2009. Additionally, section 134(b) of the MIPPA sets a permanent 1.500 work GPCI floor in Alaska, beginning January 1, 2009. As such, the CY 2009 GPCIs and summarized

GAFs reflect these statutorily mandated work GPCI floors.

G. Section 136: Extension of Treatment of Certain Physician Pathology

Services Under Medicare

The TC of physician pathology services refers to the preparation of the slide involving tissue or cells that a pathologist will interpret.

In contrast, the pathologist's interpretation of the slide is the PC service. If the PC service is furnished by the hospital pathologist for a hospital patient, it is separately billable. If the independent laboratory's pathologist furnishes the PC service, it is usually billed with the TC service as a combined service.

In the CY 2000 PFS final rule, we stated that we would implement a policy to pay only the hospital for the TC of physician pathology services furnished to hospital inpatients (64 FR 59380, 59408 through 59409). Prior to this proposal, any independent laboratory could bill the Medicare contractor under the PFS for the TC of physician pathology services for hospital inpatients. At the request of commenters on the final rule that independent laboratories and hospitals needed sufficient time to negotiate arrangements, we delayed the implementation of that rule until 2001.

Section 542 of the Medicare, Medicaid, and SCHIP Benefits

Improvement and Protection Act of 2000 (Pub. L. 106-554) (BIPA) established the billing exception that allowed certain qualified independent laboratories to continue to bill the Medicare contractor under the PFS for the TC of physician pathology services furnished to a hospital patient. In order to bill in this manner, an independent laboratory must have had an arrangement with a hospital in effect as of

July 22, 1999 under which the laboratory furnished the TC of the physician pathology service to a hospital patient and submitted claims to the Medicare contractor for payment. This provision was initially effective for 2 years, 2001 through 2002.

Through subsequent legislation (that is, section 732 of the MMA, section 104 of the MIEA-TRHCA, section 104 of the MMSEA, and section 136 of the MIPPA), this provision has been extended through December 31, 2009. If the independent laboratory did not qualify under this provision, then it must continue to bill the hospital and receive payment from that hospital. As a result of this provision, the TC of physician pathology services could be paid differently depending on the status of the laboratory.

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H. Section 141: Extension of Exceptions Process for Medicare Therapy

Caps 1. Background

Section 1833(g)(1) of the Act applies an annual per beneficiary combined cap beginning January 1, 1999, on outpatient physical therapy and speech-language pathology services, and a similar separate cap on outpatient occupational therapy services. These caps apply to expenses incurred for the respective therapy services under Medicare Part B, with the exception of outpatient hospital services.

The exceptions process for the therapy caps, originally authorized by section 5107 of the DRA, was extended from January 1, 2006 through

December 31, 2007 by section 201 of the MIEA-TRHCA. Section 105 of the

MMSEA provided for a further extension of this exceptions process through the first 6 months of CY 2008 (that is, January 1, 2008 through

June 30, 2008). 2. MIPPA Provision for Cap Exceptions

Section 141 of the MIPPA extends the exceptions process for therapy caps from July 1, 2008 through December 31, 2009.

Section 1833(g)(2) of the Act provides that, for CY 1999 through CY 2001, the caps were $1500, and for the calendar years after 2001, the caps are equal to the preceding year's cap increased by the percentage increase in the Medicare Economic Index (MEI) (except that if an increase for a year is not a multiple of $10, it is rounded to the nearest multiple of $10). The annual, per beneficiary therapy cap for 2009 will be $1840 for physical therapy and speech-language pathology services combined and $1840 for occupational therapy services, separately. The MIPPA does not create a separate cap for SLP services.

I. Section 143: Speech-Language Pathology Services 1. Background

Currently, therapy services [physical therapy (PT), occupational therapy (OT), and speech-language pathology (SLP)] may be billed by providers, such as hospitals, and by suppliers, such as physicians or

NPPs. Physical therapists and occupational therapists may also independently enroll as suppliers of Medicare services, and may bill and receive payment for their services furnished in private practice.

Prior to enactment of the MIPPA, the statute did not allow SLPs to enroll independently and to be paid directly.

The amendments made by section 143 of the MIPPA provide the authority for CMS to enroll speech-language pathologists as suppliers of Medicare services, and for speech-language pathologists to begin billing Medicare for outpatient SLP services furnished in private practice beginning July 1, 2009. Enrollment will allow SLPs in private practice to bill Medicare and receive direct payment for their services.

In general, section 143 of the MIPPA amends the statute to give speech-language pathology services the meaning given the term

``physical therapy services'' in section 1861(p) of the Act. This provides the authority to enroll speech-language pathologists and to pay them for their services in the same way as physical therapists that are separately enrolled. Section 143 made conforming changes to the scope of benefits in section 1832(a)(2)(C) of the Act to include outpatient speech-language pathology services furnished in a private practice. Section 143 of the MIPPA also makes the following changes to the Act:

Section 1832(a)(2)(C) of the Act is amended to specifically include outpatient speech-language pathology services in the scope of benefits for which payment may be made.

Section 1833(a)(8) of the Act is amended to describe outpatient SLP services as separate and distinct services from PT.

Section 1833(g)(1) is amended to separately describe outpatient SLP services, but the amendments do not create a separate therapy cap for SLP services. The cap for PT and SLP combined is $1840 per beneficiary in CY 2009.

Section 1835(a) of the Act is amended to specify that payment may be made for outpatient SLP services to a provider of services, including a clinic, rehabilitation agency or public health agency that meets the requirements described in the amended section 1861(p)(4)(A) and (B) of the Act.

Section 1861(p) of the Act is amended to remove from the definition of ``outpatient physical therapy services'' SLP services furnished by or under arrangements or supervision of a provider. These

SLP services are deleted from the definition of outpatient physical therapy services because SLP services are now defined separately under section 1861(ll)(2) of the Act.

Section 1861(s)(2)(D) of the Act is amended to add outpatient SLP services as medical and other health services, along with outpatient PT and OT.

Section 1862(a)(20) of the Act is amended to add SLP services to the list of therapy services for which Medicare payment cannot be made if furnished as an incident to a physician's professional services unless standards and conditions specified by the

Secretary (other than licensing) are met, as such standards and conditions would apply to such services if furnished by a therapist.

Section 1866 of the Act is amended to include SLP services in the description of services that can be considered furnished by a provider of services when furnished by a clinic, rehabilitation agency, or public health agency that meets certain requirements.

Section 1877 of the Act is amended to include outpatient

SLP services in the list of designated health services for the purpose of the prohibition on certain physician referrals. (See section VI.B. of this preamble for a discussion of these changes.) 2. Implementation of the MIPPA

Section 143 of the MIPPA amends the statute to treat speech- language pathologists (SLP) and speech-language pathology services in a similar manner to physical therapists and physical therapy services.

Physical therapists are permitted to enroll in Medicare and to furnish and bill for their services in private practice. To conform SLP regulations to those for PT, we are adding provisions for services furnished by SLPs in private practice to Sec. 410.62(c) using language similar to the provisions of Sec. 410.59 and Sec. 410.60 that apply to OT and PT enrollment. In Sec. 410.62, we are redesignating the paragraph (c) as paragraph (d). The current paragraph (d) is deleted since this language is covered in Sec. 410.60.

The amendments made by section 143 of the MIPPA concerning SLP enrollment, billing and payment are generally self-implementing and we are revising our regulations accordingly as noted above consistent with our policies for PTs.

Section 410.62(c) contains a list of requirements that SLPs must meet. The regulations require that an SLP be legally authorized to engage in SLP private practice in the State where he or she practices.

The SLP must practice only within the scope of practice allowed by the

State. Section 410.62(c)(1)(ii) describes the various practice types in which an individual SLP may provide services.

Section 410.62(c)(1)(iii)(A) requires that SLPs in private practice must bill Medicare for services furnished in the State where they are licensed, in the locations where the practice is operated, at a time when the practice is operating. The space must be owned, leased or rented by the practice and used for the exclusive purpose of operating the practice during those hours the practice

Continued on page 69875

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

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pp. 69875-69924

Medicare Program; Payment Policies Under the Physician Fee

Schedule and Other Revisions to Part B for CY 2009; E-Prescribing

Exemption for Computer-Generated Facsimile Transmissions; and Payment for Certain Durable Medical Equipment, Prosthetics, Orthotics, and[Page 69875]

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is furnishing services to beneficiaries. Private practice services may be furnished at a patient's home, but not at an institution that is a hospital, CAH or SNF.

Section 410.62(c)(iv) also requires that SLPs must treat individuals who are patients of the practice and for whom the practice collects fees for the services furnished. 3. Operational Issues

We will revise our manual instructions to reflect that SLPs can now enroll and be paid directly by Medicare for services furnished on or after July 1, 2009. SLPs who wish to enroll in Medicare may submit their Medicare enrollment application to their local Medicare contractor on or after June 2, 2009. Before submitting a Medicare enrollment application, SLPs are required to obtain a National Provider

Identifier, if they do not currently have one. For general information on the Medicare provider enrollment process, please see the CMS Web site at http://www.cms.hhs.gov/MedicareProviderSupEnroll.

To educate the public about this change, we will discuss the new enrollment instructions during an upcoming Physician and Allied Health

Professionals Open Door Forum. In the coming months, we will also revise our manual instructions and issue a MLN Matters article and listserv messages to inform the public that SLPs may enroll as suppliers of Medicare services and begin billing Medicare for outpatient SLP services furnished in private practice beginning July 1, 2009. We also plan to contact national associations and request that they notify their members about these changes. Finally, we will require our Medicare contractors to contact SLPs via bulletins or listserv announcements about these changes.

J. Section 144(b): Repeal of Transfer of Title for Oxygen Equipment 1. Payment Rules for Oxygen and Oxygen Equipment a. Overview

The general Medicare payment rules for durable medical equipment

(DME) are set forth in section 1834(a) of the Act and 42 CFR part 414, subpart D of our regulations. Section 1834(a)(1) of the Act and Sec. 414.210(a) of our regulations establish the Medicare payment for a DME item as equal to 80 percent of either the lower of the actual charge or the fee schedule amount for the item. The beneficiary coinsurance is equal to 20 percent of either the lower of the actual charge or the fee schedule amount for the item once the deductible is met.

Specific rules regarding payment for oxygen and oxygen equipment are set forth in section 1834(a)(5) of the Act and Sec. 414.226 of our regulations. Suppliers are paid a monthly payment amount for furnishing medically necessary oxygen contents (stationary and portable) and stationary oxygen equipment falling under the class described in Sec. 414.226(c)(1)(i). Equipment in this class includes stationary oxygen concentrators, which concentrate oxygen from room air; stationary liquid oxygen systems, which use oxygen stored as a very cold liquid in cylinders and tanks; and gaseous oxygen systems, which administer compressed oxygen directly from cylinders.

We also pay a monthly add-on payment to suppliers furnishing medically necessary portable oxygen equipment falling under one of two classes described in Sec. 414.226(c)(1)(ii) and (iii). Equipment in these classes includes portable liquid oxygen systems, portable gaseous oxygen systems, portable oxygen concentrators, and oxygen transfilling equipment used to fill portable tanks or cylinders in the home. Both liquid and gaseous oxygen systems (stationary and portable) require on- going delivery of oxygen contents. b. Provisions of the Deficit Reduction Act of 2005 (DRA)

Section 5101(b) of the DRA amended section 1834(a)(5) of the Act, limiting monthly payments to suppliers for oxygen equipment to 36 months of continuous use. At the end of this 36-month period, suppliers must transfer title to oxygen equipment rented on or after January 1, 2006 to the beneficiary. Payments for oxygen contents continue after title to the equipment has been transferred.

On November 9, 2006, we issued a final rule (71 FR 65884) to implement these changes. We amended Sec. 414.226 to clarify that the monthly payments for items falling under the classes now described in

Sec. 414.226(c)(1)(i) thru (iii) are made for periods of continuous use not to exceed 36 months. We revised the rules regarding a period of continuous use for the rental of DME in Sec. 414.230 of our regulations to clarify the continuous use determination.

We also added a new paragraph (f) to Sec. 414.226 of our regulations, requiring a supplier to transfer title to the oxygen equipment to the beneficiary on the first day after the 36th continuous month in which payment is made for the equipment.

In addition, we revised Sec. 414.226 of our regulations to allow monthly payments to suppliers for furnishing gaseous or liquid oxygen contents for use with either beneficiary-owned stationary equipment or beneficiary-owned portable equipment.

Section 5101(b) of the DRA also authorized payments for maintenance and servicing of beneficiary-owned oxygen equipment if the Secretary determined such payments to be reasonable and necessary. In keeping with the longstanding Medicare policy to pay for maintenance and servicing of DME that is owned by the beneficiary, we determined that paying for necessary repairs and periodic maintenance and servicing of beneficiary-owned oxygen equipment was reasonable and necessary to ensure that oxygen equipment owned by beneficiaries continued to function properly. Without these payments, we were concerned that there was little incentive for suppliers to maintain this equipment, because the equipment was no longer owned by the supplier. Our regulations setting forth this payment amount are discussed in more detail in section III.J.2.c. below in this section.

In the November 2006 final rule, we established other safeguards for beneficiaries receiving oxygen and oxygen equipment, which are set forth at Sec. 414.210(e)(5) and Sec. 414.226(g). Section 414.210(e)(5) requires suppliers--after transferring title to oxygen equipment--to furnish replacement equipment at no cost to the beneficiary or the Medicare program if the item furnished by the supplier does not last for the entire reasonable useful lifetime established for the equipment in accordance with Sec. 414.210(f)(1).

Per Sec. 414.210(f), if oxygen equipment has been in continuous use by the beneficiary for the equipment's reasonable useful lifetime, the beneficiary may elect to obtain new equipment. Section 414.210(f)(1) of our regulations states the reasonable useful lifetime for equipment is determined through program instructions. In the absence of program instructions, the carrier may determine the reasonable useful lifetime for equipment, but in no case can it be less than 5 years. Computation is based on when the equipment is delivered to the beneficiary, not the age of the equipment. If the beneficiary elects to obtain replacement oxygen equipment, payment is made in accordance with Sec. 414.226(a).

Section 414.226(g)(2) prohibits suppliers from replacing oxygen equipment prior to the expiration of the 36-month rental period unless a specific exception applies. This

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was intended to protect the beneficiary from the supplier changing the beneficiary's equipment in order to maximize Medicare payments. For example, the supplier may want to move a beneficiary from a portable oxygen concentrator to portable gaseous equipment for which Medicare makes additional payments after the 36-month rental period ends.

Section 414.226(g)(4) provides that, by no later than 2 months before the date on which the supplier must transfer title to oxygen equipment to the beneficiary, the supplier must disclose to the beneficiary: (1) Whether, in the case of oxygen transfilling equipment and stationary or portable oxygen concentrators, it can maintain and service the equipment after the beneficiary acquires title to it; and

(2) whether, in the case of stationary or portable gaseous or liquid oxygen systems, it can continue to deliver oxygen contents to the beneficiary after the beneficiary acquires title to the equipment. c. Medicare Improvements for Patients and Providers Act (MIPPA) Section 144(b)--Repeal of Transfer of Ownership of Oxygen Equipment

Section 144(b) of the MIPPA repeals the requirement that the supplier transfer title to oxygen equipment to the beneficiary after the 36-month rental period. In its place, section 144(b) establishes a 36-month rental cap and amends section 1834(a)(5)(F) of the Act by adding three new payment rules and supplier requirements for furnishing oxygen and oxygen equipment after the 36-month rental period. Each of these provisions is discussed below. 2. Provisions of the Final Rule with Comment Period a. Furnishing Oxygen Equipment After the Rental Cap

As discussed above, section 144(b)(1) of the MIPPA amends section 1834(a)(5)(F)(ii)(I) of the Act, replacing the transfer of title provision with a 36-month rental cap. Under this new provision, the supplier that furnishes oxygen equipment during the 36-month rental period must continue to furnish the oxygen equipment after the 36-month rental period. The supplier is required to continue to furnish the equipment during any period of medical need for the remainder of the reasonable useful lifetime of the equipment. Section 144(b) does not provide any exceptions to the requirement that the supplier continue furnishing the equipment during any period of medical need. For example, if the beneficiary relocates at some time after the 36-month rental period but before the end of the reasonable useful lifetime of the equipment, we interpret this provision to require that the supplier must make arrangements for the beneficiary to continue receiving the equipment at his or her new place of residence. This responsibility is not transferred to another supplier. It is important to note that our current regulation at Sec. 414.226(g)(1)(ii) does not apply this same requirement to situations in which the beneficiary relocates during the 36-month rental period. We welcome comments from interested parties on whether this requirement should be changed in light of the repeal of transfer of ownership of oxygen equipment and other recently enacted provisions of the MIPPA.

We are revising Sec. 414.226(f) to conform our regulations to this new requirement. We are deleting the transfer of ownership requirement and adding the new requirement that the supplier must continue furnishing the oxygen equipment after the 36-month rental period during any period of medical need for the remainder of the reasonable useful lifetime of the equipment.

The language of the statute mandates that the supplier shall continue to furnish oxygen equipment after the 36-month rental period

``during any period of medical need'' rather than ``during the period of medical need'' for the remainder of the reasonable useful lifetime of the equipment. We interpret this to mean that the supplier is responsible for continuing to furnish the equipment at any time following the 36-month rental period and before the end of the equipment's reasonable useful lifetime, for any period of medical need, including multiple periods of medical need that are separated by periods when interruptions in the use of the equipment occur.

For example, if, following the 36-month rental period and before the end of the equipment's reasonable useful lifetime, the beneficiary is admitted to a hospital as an inpatient and then discharged from the hospital 3 weeks later, our interpretation requires the supplier to furnish the oxygen equipment for the period leading up to the hospital admission and for the period immediately following the hospital discharge through the end of the equipment's reasonable useful lifetime. The supplier's responsibility to continue furnishing the equipment is not affected by the length of a break in medical need or by the number of any such breaks in medical need that occur after the 36-month rental period and before the end of the equipment's reasonable useful lifetime. Therefore, we are revising Sec. 414.230 to specify that a new period of continuous use will not begin following the 36- month rental period until the end of the equipment's reasonable useful lifetime. The supplier is responsible for furnishing the equipment after the 36-month rental period for any period of medical need for the remainder of the reasonable useful lifetime of the equipment. If a break in medical need occurs following the 36-month rental period, the supplier must resume furnishing the oxygen equipment after the break ends and the beneficiary once again has a medical need for the oxygen equipment. In such a case, the supplier is responsible for furnishing the item for no additional rental payments until the end of the equipment's reasonable useful lifetime. If the equipment's reasonable useful lifetime (which is determined based on the date the equipment is first delivered rather than the age of the equipment) ends during a break in medical need, the supplier is under no obligation to continue furnishing the equipment once the beneficiary again has medical need for the oxygen. However, in accordance with Sec. 414.210(f), the beneficiary may elect to obtain new equipment in these situations where the reasonable useful lifetime of the equipment ends during a break in need. If the beneficiary elects to obtain new equipment, a new 36-month rental period and a new reasonable useful lifetime (currently 5 years for oxygen equipment) begin.

We note that, in accordance with section 5101(b)(2)(B) of the DRA, the rental period for beneficiaries receiving oxygen equipment on

December 31, 2005, began on January 1, 2006. However, in accordance with Sec. 414.210(f)(1), the reasonable useful lifetime of durable medical equipment, including oxygen equipment, begins on the date that the equipment is first delivered to the beneficiary. The reasonable useful lifetime of oxygen equipment furnished to beneficiaries on

December 31, 2005, was not adjusted to begin anew on January 1, 2006, to correspond with the start of the 36-month rental period. Therefore, in these situations, the equipment's reasonable useful lifetime may end at any point during or after the 36-month rental period.

For example, if oxygen equipment was delivered to a beneficiary on

May 1, 2003, and the beneficiary continued to use the equipment beyond

January 1, 2006, the 36-month rental period for the equipment would begin on January 1, 2006, and end on December 31, 2008. However, because the reasonable useful

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lifetime of the equipment ended on April 30, 2008, the beneficiary could have elected to obtain new oxygen equipment on May 1, 2008, prior to the end of the 36-month rental period for the equipment. In another example, if oxygen equipment was delivered to a beneficiary on July 1, 2004, and the beneficiary continued to use the equipment beyond January 1, 2006, the 36-month rental period for the equipment began on January 1, 2006, and will end on December 31, 2008. In this case, the reasonable useful lifetime of the equipment would end on June 30, 2009, and the beneficiary could elect to obtain new oxygen equipment on July 1, 2009, only 6 months after the end of the 36-month rental period for the equipment. In these situations, a new 36-month rental period and a new reasonable useful lifetime (for the new equipment) would begin after the end of the existing equipment's reasonable useful lifetime if the beneficiary elects to obtain new equipment.

We are also revising Sec. 414.210(e)(1), (2), (e)(4) and (e)(5) to delete regulatory text which relates to beneficiary ownership of oxygen equipment. In addition, we are deleting Sec. 414.210(e)(3) because beneficiaries will no longer own oxygen tanks and cylinders. Because

Sec. 414.210(e)(3) is being deleted, we are redesignating Sec. 414.210(e)(4) and Sec. 414.210(e)(5) as Sec. 414.210(e)(3) and Sec. 414.210(e)(4), respectively.

We are also modifying Sec. 414.226 to state that the protection against supplier replacement of oxygen equipment, unless an exception applies, continues to be in effect after the 36-month rental period ends. Specifically, we are revising Sec. 414.226(g)(2) to indicate that this prohibition applies until the expiration of the reasonable useful lifetime established for the equipment. As discussed in the

November 9, 2006 final rule (71 FR 65894), we believe this is a necessary safeguard for the beneficiary against changes in equipment made by the supplier in order to maximize payments resulting from moving from one payment class or modality to another. Finally, we are deleting Sec. 414.226(g)(4) because the transfer of ownership of oxygen equipment provision has been repealed, rendering this provision inapplicable. b. Payment for Oxygen Contents After the Rental Cap

Section 144(b)(1) of the MIPPA amends section 1834(a)(5)(F)(ii)(II) of the Act and requires us to continue to make payments to suppliers for furnishing oxygen contents after the 36-month rental cap for oxygen equipment ends. Under this provision, an oxygen supplier that furnished liquid or gaseous oxygen equipment during the 36-month rental period, and is required by section 1834(a)(5)(F)(ii)(I) of the Act to continue furnishing the equipment after the 36-month rental period ends, will receive payment for furnishing oxygen contents necessary for use with liquid or gaseous oxygen equipment after the 36-month rental period.

Section 1834(a)(5)(F)(ii)(II) of the Act establishes the payment amount for the oxygen contents as that set forth in section 1834(a)(9) of the

Act.

We are revising Sec. 414.226(d) and (f) to specify that payment shall be made for oxygen contents for use with supplier-owned liquid or gaseous oxygen equipment furnished after the 36-month rental period. An oxygen supplier that furnishes liquid or gaseous oxygen equipment during a 36-month rental period must continue to furnish both the oxygen equipment and contents for any period of medical need for the remainder of the reasonable useful lifetime of the liquid or gaseous oxygen equipment established in accordance with Sec. 414.210(f)(1).

This requirement is necessary because liquid and gaseous oxygen systems (stationary and portable) require on-going delivery of oxygen contents in tanks or cylinders to furnish oxygen to the patient. When read in conjunction with section 1834(a)(5)(F)(ii)(II) of the Act, we interpret the mandate in section 1834(a)(5)(F)(ii)(I) of the Act to include oxygen contents, as well as oxygen equipment, given the nature of this benefit and the requirement that Medicare continue to pay for oxygen contents following the 36-month rental period.

As noted in section III.J.2.a. of this final rule with comment period, we are revising Sec. 414.226(f) to specify that the supplier must make arrangements for the beneficiary to continue receiving the equipment if the beneficiary relocates at some time after the 36-month rental period but before the end of the reasonable useful lifetime of the equipment. Likewise, for the reasons set forth in section

III.J.2.a. above, we are revising Sec. 414.226(f) to specify that, in the case of liquid or gaseous equipment (stationary and portable) the supplier must make arrangements for the beneficiary to continue receiving oxygen contents if the beneficiary relocates at some time after the 36-month rental period but before the end of the reasonable useful lifetime of the liquid or gaseous equipment (stationary and portable). The supplier must make arrangements for the beneficiary to continue receiving the oxygen contents and equipment at his or her new residence. c. Maintenance and Servicing of Supplier-Owned Oxygen Equipment After the Rental Cap

Section 1834(a)(5)(F)(ii)(III) of the Act, as amended by section 144(b)(1) of the MIPPA, authorizes payments for maintenance and servicing of supplier-owned oxygen equipment after the 36-month rental period if the Secretary determines that such payments are reasonable and necessary. Section 5101(b)(1) of the DRA previously authorized payment for reasonable and necessary maintenance and servicing of beneficiary-owned oxygen equipment. i. Current Payment for Maintenance and Servicing of Oxygen Equipment

In the August 3, 2006 proposed rule for implementing section 5101(b) of the DRA (71 FR 44082), we discussed the fact that it is longstanding Medicare policy to pay for repair (fixing or mending) of beneficiary-owned DME if such services are necessary to keep the equipment functioning. It is also longstanding Medicare policy to pay for non-routine maintenance of beneficiary-owned DME (that is, extensive maintenance that must be performed by skilled technicians).

These policies were discussed in the November 9, 2006 final rule (71 FR 65918) and are set forth in Sec. 414.210(e)(1) and sections 40 and 50 of chapter 20 of the Medicare Claims Processing Manual (Pub. 100-04).

In keeping with these longstanding Medicare policies, we proposed to pay for both services when performed on beneficiary-owned oxygen equipment following passage of the DRA (see the proposed rule published on August 3, 2006 (71 FR 44082)).

In response to the August 3, 2006 proposed rule, we received public comments concerning the safe use and maintenance and servicing of oxygen equipment once the supplier transferred title of the equipment to the beneficiary. Commenters raised concerns that beneficiaries would be unable to properly maintain their equipment and that unless Medicare paid for maintenance and servicing of beneficiary-owned equipment, suppliers would not have any incentive to provide these services.

In response to these concerns, we finalized our proposal to pay for necessary repairs and non-routine maintenance of beneficiary-owned oxygen equipment (See 71 FR 65917 through 65919) in accordance with the rules set forth at Sec. 414.210(e). In addition, we revised Sec. 414.210(e) to allow for payment for general

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maintenance and servicing of beneficiary-owned oxygen equipment other than liquid or gaseous equipment (stationary and portable).

Section 414.210(e)(2) authorized payment for 30 minutes of labor for general maintenance and servicing of beneficiary-owned oxygen transfilling equipment and stationary or portable oxygen concentrators every 6 months, beginning 6 months after transfer of title to the equipment to the beneficiary. Medicare also made payment for parts replaced during the general maintenance and servicing of the beneficiary-owned oxygen equipment. As indicated in the November 9, 2006 final rule (71 FR 65917), we consider this payment for general maintenance and servicing to be an important beneficiary safeguard. The maintenance and servicing payments encourage suppliers to keep beneficiary-owned oxygen equipment in good repair which ensures the safety of the beneficiary.

The payment authorized by Sec. 414.210(e)(2) did not apply to liquid or gaseous oxygen equipment (stationary or portable) because we believe the supplier should ensure that the tanks and cylinders are functioning properly at the time it is furnishing oxygen contents.

Also, in response to concerns regarding the safe use and disposal of beneficiary-owned oxygen tanks and cylinders, we revised Sec. 414.210(e)(3) to allow payment for pick up of beneficiary-owned oxygen tanks and cylinders that are no longer medically necessary. ii. Revisions as a Result of the MIPPA

(1) Findings Related to Non-Routine Maintenance and Servicing

(Including Repair)

Section 1834(a)(5)(F)(ii)(III), as amended by section 144(b)(1) of the MIPPA, authorizes similar payments for maintenance and servicing of supplier-owned oxygen equipment furnished after the 36-month rental period if we determine such payments are reasonable and necessary.

Based on a careful review of this issue, as discussed below, we have determined that at this time it is not reasonable and necessary to pay for non-routine maintenance and servicing (including repair) of supplier-owned oxygen equipment. Given that the supplier owns the equipment, we believe that the supplier should be responsible for maintaining their equipment in working order as they did during the 36- month rental period.

In addition, oxygen equipment is largely reliable equipment which requires minimal maintenance and servicing during the first 5 years of use. Warranties covering 5 years are generally available for the top selling brands of oxygen equipment and as discussed in the November 9, 2006 final rule (71 FR 65917), we understand from manufacturers that such products are generally dependable. The Department of Veterans

Affairs (VA) has reported to us that, based on their experience, oxygen concentrators will usually operate for 5 years without the need for significant repair or replacement of costly parts. The VA purchases and maintains oxygen equipment, including oxygen concentrators, for veterans through its Veterans Integrated Service Network (VISN).

In a September 2006 report entitled ``Medicare Home Oxygen

Equipment: Cost and Servicing,'' (OEI-09-04-00420), the Office of

Inspector General (OIG) of the Department of Health and Human Services similarly found that only minimal servicing and maintenance for oxygen concentrators and portable equipment is necessary. The OIG also found that suppliers train beneficiaries to perform routine maintenance of the equipment. As noted in that report, services performed by suppliers during visits to the homes of beneficiaries to perform maintenance and servicing of oxygen concentrators include checking the flow rate prescribed by the physician and checking the concentration of oxygen delivered by the unit.

Moreover, the OIG found that only 22 percent of Medicare beneficiaries use oxygen equipment for 36 months or more. Therefore, oxygen equipment is returned to suppliers before the end of the 36- month rental period in approximately 78 percent of cases, and suppliers are then able to furnish the equipment to other beneficiaries, starting new 36-month periods of rental payments for the same equipment. Based on current Medicare fee schedule amounts, during a 5-year period in which a supplier rents an oxygen concentrator to multiple beneficiaries, each using the equipment for less than 36 months, the supplier is paid $11,957 for furnishing the oxygen concentrator, the average cost of which was found by the OIG to be $587. Even in the minority of cases in which beneficiaries use oxygen equipment for more than 36 months, the supplier is paid $7,174 for furnishing the equipment. Given this level of reimbursement, it is reasonable to assume that each Medicare beneficiary should be receiving a fairly new piece of oxygen equipment. If the supplier chooses instead to provide older equipment to the beneficiary, we expect that the supplier, and not Medicare or the beneficiary, should be responsible for performing any non-routine maintenance and servicing (including repair) of the supplier-owned equipment to ensure that it continues to function properly during the 5-year reasonable useful lifetime of the equipment.

(2) Finding Related to Routine Maintenance and Servicing

We have determined at this time that it is not reasonable and necessary to make payments for repair or non-routine maintenance and servicing (including repair) of supplier-owned oxygen equipment. We have made an initial determination that payments for periodic, in-home visits by suppliers to inspect certain oxygen equipment and provide general maintenance and servicing during these visits are reasonable and necessary for the safety of the beneficiary. Therefore, for CY 2009 only, we are revising Sec. 414.210(e)(2), which provides payment for general maintenance and servicing of certain beneficiary-owned oxygen equipment, to apply to routine maintenance and servicing of supplier- owned oxygen concentrators and transfilling equipment furnished after the 36-month rental period consistent with our authority in section 1834(a)(5)(F)(ii)(III) of the Act. Based on our preliminary analysis, we believe that payments in CY 2009 for periodic inspection and general maintenance and servicing of oxygen concentrators and transfilling equipment are reasonable and necessary for the safety of beneficiaries.

Therefore, for CY 2009 only, we will make payments when the supplier performs a routine maintenance and servicing visit following each period of continuous use of 6 months after the 36-month rental period ends. Determining a period of continuous use is governed by Sec. 414.230, which we discussed in section III.J.2.a. above.

Payments for a routine maintenance and servicing visit in CY 2009 will be made when the beneficiary is at home or at a temporary residence (for example, a vacation residence). For each visit, we believe that it is appropriate to provide payment for 30 minutes of labor for general maintenance and servicing of oxygen equipment other than liquid or gaseous equipment (stationary and portable). As we indicated in the November 9, 2006 final rule for implementing section 5101(b) of the DRA (71 FR 65917), we believe that payment for 30 minutes of labor will adequately compensate suppliers for general maintenance and servicing visits based on findings by the OIG in their

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September 2006 report (OEI-09-04-00420) that many routine maintenance activities performed by suppliers on concentrators could be performed within that timeframe.

We expect that the primary purpose of the periodic visit would be to check the supplier-owned oxygen equipment to ensure that it will continue to function properly for the succeeding 6-month period of continuous use and does not need to be replaced. We are revising Sec. 414.210(e)(2) to permit payment in CY 2009 for general maintenance and servicing of supplier-owned oxygen equipment beginning 6 months after the end of the 36-month rental period.

As a result, we will make payments under Sec. 414.210(e)(2) only for an actual visit to the beneficiary's home or temporary residence.

This provision is generally consistent with the additional maintenance and servicing payments established at Sec. 414.210(e)(2) after the enactment of the DRA, except that, in light of the repeal of transfer of title for oxygen equipment provisions, separate payment will not be made for parts replaced during the routine maintenance and servicing visit. If parts need to be replaced in order to make supplier-owned equipment suitable for the beneficiary, we believe that the supplier should be responsible for replacing the parts on equipment from their inventory in order to meet the beneficiary's medical need for oxygen.

We will make payments for general maintenance and servicing of oxygen concentrators and transfilling equipment as discussed above.

However, we welcome comments from interested parties on this issue, especially regarding whether these payments should continue past CY 2009 in light of the OIG's findings that only minimal maintenance and servicing of oxygen equipment is necessary and that suppliers continue to own the equipment.

K. Section 145: Clinical Laboratory Tests

Outpatient clinical laboratory services are paid under the clinical laboratory fee schedule (CLFS) in accordance with section 1833(h) of the Act. Section 1833(h)(2)(A)(i) of the Act specifies that the fee schedules are adjusted annually, to become effective on January 1 of each year, by a percentage increase or decrease equal to the percentage increase or decrease in the Consumer Price Index for All Urban

Consumers (United States city average) (CPI-U). The Congress has frozen the update to zero percent for CYs 2004 through 2008. The freeze on the annual update expires beginning January 1, 2009.

For the period beginning January 1, 2009, the update factor for the clinical lab fee schedule would be 5.0 percent. However, section 145(b) of the MIPPA reduces this increase by 0.5 percent for each of the years 2009 through 2013. Therefore, for the period January 1, 2009, through

December 31, 2009, payments under the Clinical Laboratory Fee Schedule will be increased by 4.5 percent.

L. Section 146: Improved Access to Ambulance Services

Section 146(a) of the MIPAA modifies section 1834(l)(13) of the Act to specify that, effective for ground ambulance claims furnished during the period July 1, 2008, the ambulance fee schedule through December 31, 2009 amounts for ground ambulance services shall be increased as follows:

For covered ground ambulance transports which originate in a rural area or in a rural census tract of a metropolitan statistical area, the fee schedule amounts shall be increased by 3 percent; and

For covered ground ambulance transports which do not originate in a rural area or in a rural census tract of a metropolitan statistical area, the fee schedule amounts shall be increased by 2 percent.

We are revising Sec. 414.610(c)(1) to conform the regulations to this statutory requirement. This statutory requirement is self- implementing. A plain reading of the statute requires only a ministerial application of the mandated rate increase, and does not require any substantive exercise of discretion on the part of the

Secretary. We note that in adding language to Sec. 414.610(c)(1) to set forth this statutory requirement, we have also divided it into 2 paragraphs for purposes of clarity.

In addition, section 146(b)(1) of the MIPPA specifies that any area that was designated as a rural area for purposes of making payments under the ambulance fee schedule for air ambulance services furnished on December 31, 2006, shall be treated as a rural area for purposes of making payments under the ambulance fee schedule for air ambulance services furnished during the period July 1, 2008 through December 31, 2009. Accordingly, for areas that were designated rural on December 31, 2006, and were subsequently redesignated as urban, we have re- established the ``rural'' indicator on the zip code file for air ambulance services effective July 1, 2008. We are revising Sec. 414.610 to add a new paragraph (h) to conform the regulations to this statutory requirement. This statutory requirement is self-implementing.

A plain reading of the statute requires only a ministerial application of a rural indicator, and does not require any substantive exercise of discretion on the part of the Secretary.

M. Section 149: Adding Certain Entities as Originating Sites for

Payment of Telehealth Services

Section 1834(m)(4)(C) of the Act defines a telehealth ``originating site'' to mean only those sites described in the statute at which an eligible telehealth individual is located at the time the service is furnished via a telecommunications system. The statute requires originating sites to be located in an area that is designated as a rural health professional shortage area under section 332(a)(1)(A) of the Public Health Service Act (42 U.S.C. 254e(a)(1)(A)); in a county that is not included in a Metropolitan Statistical Area; or in an entity that participates in a Federal telemedicine demonstration project that has been approved by (or receives funding from) the

Secretary of Health and Human Services as of December 31, 2000.

Previously, the statute described the following originating sites: the office of a physician or practitioner; a critical access hospital (as defined in section 1861(mm)(1) of the Act); a rural health clinic (as defined in section 1861(aa)(2) of the Act); a Federally qualified health center (as defined in section 1861(aa)(4) of the Act); and a hospital (as defined in section 1861(e) of the Act).

Section 149 of the MIPPA amended section 1834 of the Act to add certain entities as originating sites for payment of telehealth services. As explained further below, MIPPA also amended section 1888(e)(2)(A)(ii) of the Act to exclude telehealth services furnished under section 1834(m)(4)(C)(ii)(VII) from the consolidated billing provisions of the skilled nursing facility prospective payment system

(SNF PPS).

With respect to a telehealth service, subject to section 1833(a)(1)(U) of the Act, we pay a facility fee to the originating site. The originating site facility fee is a separately billable Part B payment, and we pay it to eligible originating sites outside of other payment methodologies. As discussed in section X. of this final rule with comment period, the originating site facility fee for CY 2009 is

$23.72.

Other than adding certain entities as originating sites for payment of telehealth services, the MIPPA did not change the existing telehealth eligibility criteria, or payment and billing requirements related to telehealth services. Therefore, for the telehealth originating sites added by section 149 of

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the MIPPA, we are adopting policies similar to existing policies with respect to the provision of, and payment for, telehealth services in the various originating sites. We are adopting these policies for CY 2009 on an interim final basis, and will respond to any comments and finalize our policies in subsequent rulemaking.

Telehealth is a delivery mechanism for otherwise payable Part B services. We pay distant site physicians or practitioners for Medicare telehealth services only if the service is separately payable under the

PFS when furnished in a face-to-face encounter at that location. For example, we pay distant site physicians or practitioners for furnishing services via telehealth only if such services are not included in a bundled payment to the facility that serves as the originating site.

The regulations relating to the Medicare telehealth provisions under section 1834(m) of the Act are at Sec. 410.78, which specifies the conditions of payment for telehealth services, and Sec. 414.65, which specifies the payment rules for telehealth services. (See also the CMS Internet-Only Medicare Benefit Policy Manual, Pub. 100-02,

Chapter 15, Section 270, and the CMS Internet-Only Medicare Claims

Processing Manual, Pub. 100-04, Chapter 12, Section 190 for more information on Medicare telehealth services and for updated instructions for billing the originating site facility fee.)

As noted previously, the telehealth originating site facility fee is a separately billable Part B payment that is payable outside of any other payment methodology. Renal Dialysis Centers, Community Mental

Health Centers, and SNFs are all paid based under different payment systems.

Renal Dialysis Centers

Section 149 of the MIPPA added hospital-based or CAH-based renal dialysis centers (including satellites) to the list of originating sites for Medicare telehealth services. As defined in Sec. 405.2102, a renal dialysis center is a hospital unit or satellite approved to furnish outpatient maintenance dialysis services required for the care of end-stage renal disease (ESRD) dialysis patients. Independent renal dialysis facilities are not authorized in the law to serve as originating sites for Medicare telehealth services. Medicare pays for outpatient maintenance dialysis services based on a case-mix adjusted composite rate which includes the cost of some drugs, laboratory tests, and other items and services routinely furnished to dialysis patients.

Medicare pays separately for physicians' professional services, separately billable laboratory tests, and separately billable drugs furnished in ESRD facilities. When a hospital-based or CAH-based renal dialysis center (or their satellite) serves as the originating site for a Medicare telehealth service, the originating site facility fee is payable in addition to any case-mix adjusted composite rate or, as explained further below, any monthly capitation payment (MCP) amount.

The originating site facility fee is a separately billable Part B payment.

The Medicare composite rate for ESRD facilities includes payment for social and dietetic services to meet the needs of the ESRD patient.

To prevent duplicate payment for services that the renal dialysis center is required to furnish directly, and for which payment is included in the case-mix adjusted composite rate, we will not pay separately for the services of clinical social workers (CSW), registered dietitians, and nutrition professionals furnished via telehealth to ESRD outpatients in renal dialysis centers.

Physicians and practitioners managing ESRD facility patients are paid a monthly rate (the MCP) for most outpatient maintenance dialysis- related physician services furnished to a Medicare ESRD beneficiary.

The MCP amount varies based on the number of visits provided within each month and the age of the ESRD beneficiary.

When the MCP is billed for ESRD-related services with 2 or 3 visits per month or for ESRD-related services with 4 or more visits per month, some of the visits may be furnished as a telehealth service. However, at least one visit per month is required to be furnished by the physician or practitioner in person to examine the vascular access site. A clinical examination of the vascular access site must be furnished once per month face-to-face (not as a telehealth service) by a physician, nurse practitioner, or physician's assistant.

Consistent with existing policy, non-ESRD-related physicians' services may be furnished via telehealth by the physician or practitioner who furnishes renal care or by another physician or practitioner. These are services that are not incidental to services furnished during a dialysis session or office visits necessitated by the renal condition. The physician or practitioner must provide documentation that the illness is not related to the renal condition and that the additional visits are medically necessary. The Medicare contractor's medical staff determines whether additional reimbursement is warranted for treatment of the unrelated illness. Medicare does not pay separately for ESRD-related services furnished via telehealth that are covered by the MCP. (See the CMS Internet-Only Medicare Claims

Processing Manual, Pub. 100-04, Chapter 8, Section 140, for more information on Medicare policy regarding the monthly capitation payment method for physicians' services.)

Community Mental Health Centers

Section 149 of the MIPPA added community mental health centers

(CMHCs), as defined in section 1861(ff)(3)(B) of the Act, to the list of originating sites for Medicare telehealth services. The Medicare statute recognizes CMHCs as ``providers of services'' for purposes of furnishing partial hospitalization programs (PHP). PHPs are structured and intensive programs consisting of a group of mental health services paid on a per diem basis under the OPPS. A CMHC receives a per diem payment for each PHP day, which consists of a minimum of three PHP services. The HCPCS codes that are eligible for PHP services and count towards the number of PHP service units required to receive the per diem payment were originally defined in the April 7, 2000, OPPS final rule with comment period (65 FR 18454).

The Medicare telehealth originating site facility fee is not a PHP service and, as such, it does not count towards the number of PHP services for purposes of determining payment to a CMHC for partial hospitalization services. The originating site facility fee is not bundled into the per diem payment for partial hospitalization. With respect to a Medicare telehealth service furnished by a physician or practitioner to a beneficiary at a CMHC, the originating site facility fee is separately payable under Part B.

Consistent with existing policy, physicians and practitioners furnishing services to beneficiaries in CMHCs can bill Medicare Part B for telehealth services as long as the service would be separately payable under the PFS when furnished in a face-to-face encounter at that location. However, as noted above, PHP services furnished via telehealth will not be included in the count of services used to determine whether the CMHC should receive a PHP per diem payment.

Rather, in order to avoid duplicate payment, the facility is paid for its role in furnishing telehealth services through the originating site facility fee. Regardless of whether the CMHC has provided the minimum number of PHP services to receive a per diem payment, CMHCs can bill and receive payment for the originating site facility fee with respect to a Medicare telehealth service that would otherwise

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be eligible for payment at the CMHC. (See the CMS Internet-Only

Medicare Claims Processing Manual, Pub. 100-04, Chapter 4, Section 260, for more information on Medicare payment policy regarding partial hospitalization program services.)

The PHP per diem payment includes the services of clinical social workers (CSWs) and other support staff trained to work with psychiatric patients. CSW services furnished under a PHP are included in the partial hospitalization rate. To prevent duplicate payment for services that the CMHC is required to furnish and that are paid to the CMHC through the PHP per diem payment, Medicare does not pay separately for the services of CSWs furnished via telehealth to beneficiaries receiving partial hospitalization services in a CMHC.

Skilled Nursing Facilities

Section 149 of the MIPPA added skilled nursing facilities (SNFs), as defined in section 1819(a) of the Medicare statute, to the list of originating sites for Medicare telehealth services. For residents in a covered Part A SNF stay, the SNF receives a bundled per diem payment under the SNF PPS for all covered skilled nursing facility services as defined under section 1888(e)(2)(A) of the statute. The conforming amendment in section 149(b) of the MIPPA amended section 1888(e)(2)(A)(ii) of the Act to exclude telehealth services furnished under section 1834(m)(4)(C)(ii)(VII) of the Medicare statute from the definition of ``covered skilled nursing facility services'' that are paid under the SNF PPS. Therefore, when a SNF serves as the originating site for Medicare telehealth services, the SNF can receive separate payment for a telehealth originating site facility fee even in those instances where it also receives a bundled per diem payment under the

SNF PPS for a resident's covered Part A stay. Moreover, not only would the originating site facility fee be separately billable outside of the

SNF PPS, but so would those professional services (furnished at the distant site) that meet the criteria specified in section 1834(m)(2)(A) of the Act for payment as Medicare telehealth services. As indicated previously, under section 1834(m)(2)(A) of the Act, telehealth is a delivery mechanism for otherwise payable Part B services; that is, services which would be separately payable under Part B if ``* * * furnished without the use of a telecommunications system'' (emphasis added). This means that distant site professional services can qualify for separate telehealth payment only to the extent that they are not already included within a bundled payment to the facility that serves as the originating site. Thus, services furnished to a SNF resident from the distant site by a physician, physician assistant, nurse practitioner, clinical nurse specialist, certified nurse-midwife, or qualified psychologist would be separately billable as telehealth services, as the services of all of these practitioner types are excluded from payment under the SNF PPS under section 1888(e)(2)(A)(ii) of the Act. However, the services of other practitioners such as clinical social workers (CSWs), registered dietitians, and nutrition professionals are subject to SNF consolidated billing when furnished to the SNF's Part A resident. In order to avoid duplicate payment, telehealth services furnished by these practitioners would be separately billable telehealth services only in those cases where the

SNF resident who receives them is not in a covered Part A stay.

Thus, for services that SNF residents receive during the course of a covered Part A stay, the MIPPA's designation of a SNF as a telehealth setting effectively leaves unchanged the scope of the bundled per diem payment that the SNF PPS makes for the covered stay itself.

Accordingly, the use of telehealth as a vehicle for service delivery would not serve to bundle types of services (such as those of physicians) that are otherwise separately payable under Part B when furnished to such residents, nor would it serve to unbundle types of services (such as those of CSWs) that are otherwise included within the bundled SNF PPS payment.

In order to reflect this conforming amendment, we are revising the implementing regulations at Sec. 411.15(p)(2) to include an additional clause, which specifies that types of services that would otherwise be excluded from SNF consolidated billing when furnished in a face-to-face encounter are also excluded when furnished via telehealth under section 1834(m)(4)(C)(ii)(VII) of the Act. Consistent with the preceding discussion, this revision serves to clarify that a type of service

(such as a physician service) that is otherwise excluded from SNF consolidated billing does not become subject to that provision merely by virtue of being furnished via telehealth. Similarly, we are including a conforming change in the regulations at Sec. 489.20(s) that specify compliance with consolidated billing as a requirement under the SNF's Medicare provider agreement.

N. Section 153: Renal Dialysis Provisions

The following changes affecting payment to ESRD facilities for ESRD services are effective January 1, 2009:

Under section 153(a)(1) of the MIPPA, the ESRD composite rate is increased by 1.0 percent for dialysis services furnished on or after January 1, 2009, and before January 1, 2010. This will require us to update the adjusted drug add-on adjustment as explained in section H of the preamble of this final rule.

Section 153(a)(2) of the MIPPA requires that the composite rate paid to hospital-based facilities be the same as the composite rate paid to independent renal dialysis facilities for services furnished on or after January 1, 2009. In addition, section 153(a)(2) of the MIPPA requires that in applying the geographic index to hospital-based facilities, the labor share shall be based on the labor share otherwise applied for renal dialysis facilities. Accordingly, we are revising Sec. 413.174, which describes the methodology for ESRD composite rates for hospital-based and independent facilities, to conform to the statutory requirement. These MIPPA provisions are self- implementing and require no substantive exercise of discretion on the part of the Secretary. They are discussed further in section II. H of the preamble of this final rule with comment period.

IV. Potentially Misvalued Services Under the Physician Fee Schedule

A. Valuing Services Under the Physician Fee Schedule

As explained in the CY 2009 PFS proposed rule (73 FR 38582), the

AMA RUC provides recommendations to CMS for the valuation of new and revised codes, as well as codes identified as misvalued under the 5-

Year Review of Work. On an ongoing basis, the RUC's PE Subcommittee reviews direct PE (clinical staff, medical supplies, medical equipment) for individual services and examines the many broad and methodological issues relating to the development of PE RVUs.

There has been considerable concern expressed by the Medicare

Payment Advisory Commission (MedPAC), the Congress, and other stakeholders in accurate pricing under the PFS. Despite the large increase in work RVUs for many medical visits during the last 5-Year

Review of physician work, there continues to be concern that the presence of many overvalued procedures within the PFS disadvantages primary care services and creates distortions in the PFS. Critics have stated the relative imbalance in the

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number of codes for which the work RVUs are increased rather than decreased in the three 5-Year Reviews of work RVUs.

The RUC has created the 5-Year Review Identification Workgroup to respond to these concerns regarding the valuation of codes. The workgroup identified some potentially misvalued codes through several vehicles, namely, identifying codes with site of service anomalies, high intra-service work per unit time (IWPUT), and services with high volume growth.

In the proposed rule, we indicated we would address the RUC's recommendations from the February and April 2008 meetings for codes with site of service anomalies in the CY 2009 PFS final rule with comment period in a manner consistent with the way we address other RUC recommendations and that the values for these services would be published as interim values for CY 2009.

In addition to the RUC's work, we believe that there are certain steps we can take to help address the issue of potentially misvalued services. A discussion of these steps are outlined below. 1. Updating High Cost Supplies

In the CY 2009 PFS proposed rule (73 FR 38582), we proposed a process to update high-cost supplies over $150 every 2 years. In order to obtain the typical price in the marketplace, we outlined examples of acceptable documentation and stated that we would not accept documentation that did not include specific pricing information. We also noted that if acceptable documentation was not received within the proposed rule's 60-day comment period, we would use prices from the

Internet, retail vendors, and supply catalogs to determine the appropriate cost; and, that we would use the lowest price identified by these sources. Table 25 in the proposed rule lists the top 65 high-cost supplies over $150 which needed specialty input for price updates.

Comment: We received many comments on our proposed process. Some commenters expressed support for our proposal but others thought the process was flawed and burdensome. Some commenters stated that the third year of the 4-year transition of the PE RVUs to the bottom up methodology is an inappropriate time to update pricing and also believed that the repricing of only the high-cost supplies over $150 is unfair. MedPAC and others recommended that we use an independent entity to update this pricing information in order to capture the ``average transaction prices'' that reflect the discounts and rebates offered by the manufacturers. Some commenters submitted data on the high-cost supplies listed on the table. Of the 65 high cost supplies listed, we received data on 53.

Response: Although we received some data in response to our request for information on the top 65 high cost supplies over $150, much of what we received was not complete and did not represent typical market prices. Many specialty societies submitted quotes and list prices from manufacturers for the premier models of many supply items. Where there are less expensive alternatives for certain supply items, most commenters did not report this information so we could not determine what a typical price would be. We received no pricing information for some items and commenters explained the absence of some prices by saying a particular product was no longer being manufactured. In other cases, we received incomplete pricing information, for example, a typical stent size was not indicated.

We appreciate the many thoughtful comments we received on the proposed process for updating high-cost supplies and believe this is an important area to consider when evaluating potentially overvalued services. However, we have decided not to finalize the proposed process at this time, and not to revise the prices for the supplies listed in the table. We plan to research the possibility of using an independent contractor to assist us in obtaining accurate pricing information. We plan to study the limitations of the data we received and determine how to revise our proposed process to elicit better data. We will propose a revised process in future rulemaking. 2. Review of Services Often Billed Together and the Possibility of

Expanding the Multiple Procedure Payment Reduction (MPPR) to Additional

Non-Surgical Procedures

In the CY 2009 PFS proposed rule, we stated that we plan to perform data analysis on non-surgical CPT codes that are often billed together

(for example, 60 to 70 percent of the time). This would determine if there are inequities in PFS payments that are a result of variations between services or in the comprehensiveness of the codes used to report the services or in the payment policies applied to each (for example, global surgery and MPPRs). The rationale for the MPPR is that clinical labor activities, supplies and equipment may not be performed or furnished twice when multiple procedures are performed. We stated that we would consider developing a proposal either to bundle additional services or expand application of the MPPR to additional procedures.

Comment: MedPAC requested that we consider duplicative physician work, as well as PE, in any expansion of the MPPR. Several specialty groups noted that the AMA RUC has already taken action to identify frequently occurring code pairs. The commenters support the AMA RUC's recommendation that CMS analyze data to identify nonsurgical CPT codes that are billed together 90 to 95 percent of the time. Other commenters did not believe a broad-based application of the MPPR to non-surgical services was appropriate.

Response: Based on the comments received, we will continue to work with the AMA RUC, MedPAC, and the specialty societies to determine whether there are additional services that should be either bundled or subjected to a MPPR.

B. Requested Approaches for the RUC To Utilize

In the CY 2009 PFS proposed rule, we identified methods that the

AMA RUC could undertake to assist in identifying potentially misvalued services including reviewing: (1) The Fastest Growing Procedure Codes;

(2) the Harvard-Valued Codes; and (3) PE RVUs (see 73 FR 38586).

Comment: We received many comments on this issue from various specialty groups and medical societies. Some commenters supported our proposed approaches and looked forward to participating in the process, while others expressed concern. Some specialty societies are opposed to our selection of the fastest growing procedure codes based solely on their rate of growth and total spending and cautioned CMS to consider the clinical justification for increased utilization before making any decisions to reduce the payment rates for these services.

The AMA and the AMA RUC both look forward to working with CMS on the review of the fastest growing procedure codes and have developed plans to address these codes. The AMA RUC noted that there are 2,856 services that contain Harvard-based time inputs that have not been surveyed since the Harvard studies. The AMA RUC conducted an analysis of Harvard-valued services with utilization above 10,000 services per year, which resulted in a list of 296 distinct services. The AMA RUC believes it would be effective to limit any review to these 296 services or fewer. The AMA RUC also noted that of the 296 services identified, 23 have

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already been identified by another screen and are being reviewed.

MedPAC supports our plan to review the fastest growing procedures codes, services often furnished together, and the Harvard-valued codes and believes it is consistent with their previous recommendations to

CMS. MedPAC disagrees with the process for identifying misvalued services. MedPAC believes that it is our responsibility to identify potentially misvalued services and that we should establish a standing panel of experts to help identify overvalued services and to review AMA

RUC recommendations.

The AMA RUC, MedPAC and other specialty societies requested that we clarify the timing of the 5-Year Review of PE RVUs. The AMA RUC believes that the increases to PE RVUs for some codes are not attributable to the direct inputs of the codes under the PE methodology transition. Rather, the AMA RUC believes the increases are attributable to our acceptance and incorporation of supplemental survey data for certain specialties. MedPAC supports the review of PE inputs for the fastest growing procedure codes. MedPAC also requests that CMS and the

AMA RUC review the PE inputs of high-volume codes, particularly those whose inputs are not based on physician surveys.

Response: We look forward to continuing to work with the AMA RUC in reviewing these issues and receiving alternative approaches for identifying misvalued codes from the specialty societies. We are aware that these approaches are long-term and will require time and effort from the AMA RUC and specialty societies to complete these reviews. We also believe the outlined approaches will address MedPAC's concerns. In selecting these codes and reviewing the AMA RUC's recommendations regarding misvalued codes we have taken into consideration whether there is a clinical rationale for increased utilization, and we will continue to take this into consideration in future reviews.

C. AMA RUC Review of Potentially Misvalued Codes

The AMA RUC started to review potentially misvalued codes using various screens, including codes with site of service and high IWPUT anomalies and high volume and a new technology designation, at the 2008

AMA RUC meetings. Review of the identified clinical services revealed 204 codes. Of those codes, 48 were recommended for a reduction in valuation; 38 were recommended to maintain the same valuation; 105 were referred to CPT for further code clarification; and 13 were recommended for an increase in valuation.

All of these codes were reviewed and revalued by the AMA RUC; other than the codes referred to CPT, we have agreed to accept the valuation for these codes for CY 2009, including the conforming changes to the PE inputs for these codes, as applicable. We recognize that many of the site of service anomaly code changes included deletion or modification of hospital days, office visits, intraservice time, and discharge day management services. We have concerns that the methodology used by the

AMA RUC to review the services may have resulted in removal of hospital days and deletion or reallocation of office visits without extraction of the associated RVUs. We also have concerns about the methodology used to value the high IWPUT and new technology codes. We note that the high volume codes have been referred to CPT.

Although we have some questions or concerns with certain aspects of the AMA RUC reviews of these codes, we believe the AMA RUC-recommended valuations are still a better representation of the resources used to furnish these services than the current valuations. We will continue to examine the AMA RUC recommendations and will consider whether it would be appropriate to propose further changes in future rulemaking.

During the review of the above-noted potentially misvalued codes, the AMA RUC identified three codes that they believed needed review for purposes of the PE inputs only including CPT codes 52214, 52224, and 94770. CPT codes 52214 and 52224 were identified by the high volume growth screen. As a result, the AMA RUC identified a duplication of the

PE inputs that included supplies and equipment for both the laser and electrocautery techniques and recommended this duplication be eliminated. After a review of the PE inputs in October 2008, the AMA

RUC recommended that the electrocautery PE inputs be deleted. We agree with this recommendation and have made these changes in the PE database.

CPT code 94770 was identified through the high IWPUT screen. In reviewing this diagnostic procedure, the AMA RUC and the specialty society agreed that this test is currently being used inappropriately in the nonfacility setting. The AMA RUC agreed with the specialty society that this procedure is medically appropriate only in the facility setting (provided at the patient's bedside) and that it should not be valued in the nonfacility setting. Therefore, the AMA RUC recommended that all of the PE inputs be removed from the nonfacility setting. We have accepted the AMA's RUC recommendation and we have changed the PE database to reflect these changes.

Table 26 includes codes identified in the screens identified above, as well as other CMS requests.

Table 26--AMA RUC Recommendations for Potentially Misvalued Codes

Site of

CPT code

Descriptor

AMA RUC

CMS decision

2009

service High IWPUT New tech Shift from Other CMS

High rec

WRVU

screen

PE to work request

volume

11043................ Debride tissue/

CPT Agree...............

3.04

X .......... .......... .......... .......... .......... muscle. 11044................ Debride tissue/

CPT Agree...............

4.11

X .......... .......... .......... .......... .......... bone. 14000................ Skin tissue

6.19 Agree...............

6.19

X .......... .......... .......... .......... .......... rearrangement. 14001................ Skin tissue

8.58 Agree...............

8.58

X .......... .......... .......... .......... .......... rearrangement. 14020................ Skin tissue

7.02 Agree...............

7.02

X .......... .......... .......... .......... .......... rearrangement. 14021................ Skin tissue

9.52 Agree...............

9.52

X .......... .......... .......... .......... .......... rearrangement. 14040................ Skin tissue

8.44 Agree...............

8.44

X .......... .......... .......... .......... .......... rearrangement.

Page 69884

14041................ Skin tissue

10.63 Agree............... 10.63

X .......... .......... .......... .......... .......... rearrangement. 14060................ Skin tissue

9.07 Agree...............

9.07

X .......... .......... .......... .......... .......... rearrangement. 14061................ Skin tissue

11.25 Agree............... 11.25

X .......... .......... .......... .......... .......... rearrangement. 14300................ Skin tissue

CPT Agree............... 13.26

X .......... .......... .......... ..........

X rearrangement. 15570................ Form skin pedicle 10.00 Agree............... 10.00

X .......... .......... .......... .......... .......... flap. 15572................ Form skin pedicle

9.94 Agree...............

9.94

X .......... .......... .......... .......... .......... flap. 15574................ Form skin pedicle 10.52 Agree............... 10.52

X .......... .......... .......... .......... .......... flap. 15576................ Form skin pedicle

9.24 Agree...............

9.24

X .......... .......... .......... .......... .......... flap. 15740................ Island pedicle

CPT Agree............... 11.57

X .......... .......... .......... ..........

X flap graft. 17106................ Destruction of

3.61 Agree...............

3.61 ..........

X .......... .......... .......... .......... skin lesions. 17107................ Destruction of

4.68 Agree...............

4.68 ..........

X .......... .......... .......... .......... skin lesions. 17108................ Destruction of

6.37 Agree...............

6.37 ..........

X .......... .......... .......... .......... skin lesions. 19357................ Breast

CPT Agree............... 20.57

X .......... .......... .......... .......... .......... reconstruction. 20005................ Incision of deep

CPT Agree...............

3.55

X .......... .......... .......... .......... .......... abscess. 20900................ Removal of bone

3.00 Agree...............

3.00

X .......... .......... .......... .......... .......... for graft. 20902................ Removal of bone

4.58 Agree...............

4.58

X .......... .......... .......... .......... .......... for graft. 21015................ Resection of

CPT Agree...............

5.59

X .......... .......... .......... .......... .......... facial tumor. 21025................ Excision of bone,

9.87 Agree...............

9.87

X .......... .......... .......... .......... .......... lower jaw. 21557................ Remove tumor neck/

CPT Agree...............

8.91

X .......... .......... .......... .......... .......... chest. 21935................ Remove tumor,

CPT Agree............... 18.38

X .......... .......... .......... .......... .......... back. 22554................ Neck spine fusion

CPT Agree............... 17.54 .......... .......... .......... ..........

X .......... 22851................ Apply spine

CPT Agree...............

6.70 .......... .......... .......... .......... ..........

X prosth device. 22900................ Remove abdominal

CPT Agree...............

6.14

X .......... .......... .......... .......... .......... wall lesion. 23076................ Removal of

CPT Agree...............

7.77

X .......... .......... .......... .......... .......... shoulder lesion. 23120................ Partial removal,

7.23 Agree...............

7.23

X .......... .......... .......... .......... .......... collar bone. 23410................ Repair rotator

11.23 Agree............... 11.23

X .......... .......... .......... .......... .......... cuff, acute. 23412................ Repair rotator

11.77 Agree............... 11.77

X .......... .......... .......... .......... .......... cuff, chronic. 23415................ Release of

9.07 Agree...............

9.07

X .......... .......... .......... .......... .......... shoulder ligament. 23420................ Repair of

13.35 Agree............... 13.35

X .......... .......... .......... .......... .......... shoulder. 25116................ Remove wrist/

7.38 Agree...............

7.38

X .......... .......... .......... .......... .......... forearm lesion. 25310................ Transplant

7.94 Agree...............

7.94

X .......... .......... .......... .......... .......... forearm tendon. 26080................ Explore/treat

CPT Agree...............

4.36

X .......... .......... .......... .......... .......... finger joint.

Page 69885

27048................ Remove hip/pelvis

CPT Agree...............

6.44

X .......... .......... .......... .......... .......... lesion. 27062................ Remove femur

5.66 Agree...............

5.66

X .......... .......... .......... .......... .......... lesion/bursa. 27244................ Treat thigh

18.00 Agree............... 18.00 ..........

X .......... .......... .......... .......... fracture. 27245................ Treat thigh

18.00 Agree............... 18.00 ..........

X .......... .......... .......... .......... fracture. 27250................ Treat hip

3.82 Agree...............

3.82

X .......... .......... .......... .......... dislocation. 27615................ Remove tumor,

CPT Agree............... 12.93

X .......... .......... .......... .......... .......... lower leg. 27619................ Remove lower leg

CPT Agree...............

8.47

X .......... .......... .......... .......... .......... lesion. 27640................ Partial removal

CPT Agree............... 12.10

X .......... .......... .......... .......... .......... of tibia. 27641................ Partial removal

CPT Agree...............

9.73

X .......... .......... .......... .......... .......... of fibula. 27650................ Repair achilles

9.00 Agree...............

9.00

X .......... .......... .......... .......... .......... tendon. 27654................ Repair of

10.32 Agree............... 10.32

X .......... .......... .......... .......... .......... achilles tendon. 27690................ Revise lower leg

8.96 Agree...............

8.96

X .......... .......... .......... .......... .......... tendon. 27691................ Revise lower leg

10.28 Agree............... 10.28

X .......... .......... .......... .......... .......... tendon. 28120................ Part removal of

5.64 Agree...............

5.64

X .......... .......... .......... .......... .......... ankle/heel. 28122................ Partial removal

7.56 Agree...............

7.56

X .......... .......... .......... .......... .......... of foot bone. 28296................ Correction of

8.16 Agree...............

8.16

X .......... .......... .......... .......... .......... bunion. 28725................ Fusion of foot

11.97 Agree............... 11.97

X .......... .......... .......... .......... .......... bones. 28730................ Fusion of foot

12.21 Agree............... 12.21

X .......... .......... .......... .......... .......... bones. 28825................ Partial

5.85 Agree...............

5.85

X .......... .......... .......... .......... .......... amputation of toe. 29220................ Strapping of low

CPT Agree...............

0.64 .......... .......... .......... .......... ..........

X back. 29888................ Knee arthroscopy/ 14.14 Agree............... 14.14

X .......... .......... .......... .......... .......... surgery. 33213................ Insertion of

CPT Agree...............

6.36 .......... .......... .......... .......... ..........

X pulse generator. 35470................ Repair arterial

CPT Agree...............

8.62 .......... .......... .......... .......... ..........

X blockage. 35474................ Repair arterial

CPT Agree...............

7.35 .......... .......... .......... .......... ..........

X blockage. 35490................ Artherectomy,

CPT Agree............... 11.06 .......... .......... .......... .......... ..........

X percutaneous. 35491................ Artherectomy,

CPT Agree...............

7.60 .......... .......... .......... .......... ..........

X percutaneous. 35492................ Artherectomy,

CPT Agree...............

6.64 .......... .......... .......... .......... ..........

X percutaneous. 35493................ Artherectomy,

CPT Agree...............

6.64 .......... .......... .......... .......... ..........

X percutaneous. 35494................ Artherectomy,

CPT Agree............... 10.42 .......... .......... .......... .......... ..........

X percutaneous. 35495................ Artherectomy,

CPT Agree...............

9.47 .......... .......... .......... .......... ..........

X percutaneous. 36248................ Place catheter in

CPT Agree...............

1.01 .......... .......... .......... .......... ..........

X artery. 36415................ Routine

CPT Agree...............

0.00 .......... .......... .......... ..........

X .......... venipuncture. 36820................ Av fusion/forearm 14.39 Agree............... 14.39

X .......... .......... .......... .......... .......... vein. 36821................ Av fusion direct

12.00 Agree............... 12.00

X .......... .......... .......... .......... .......... any site.

Page 69886

36825................ Artery-vein

10.00 Agree............... 10.00

X .......... .......... .......... .......... .......... autograft. 36834................ Repair A-V

CPT Agree............... 11.11

X .......... .......... .......... .......... .......... aneurysm. 37760................ Ligation, leg

CPT Agree............... 10.69

X .......... .......... .......... .......... .......... veins, open. 38542................ Explore deep

7.85 Agree...............

7.85

X .......... .......... .......... .......... .......... node(s), neck. 42145................ Repair palate,

9.63 Agree...............

9.63

X .......... .......... .......... .......... .......... pharynx/uvula. 42415................ Excise parotid

17.99 Agree............... 17.99

X .......... .......... .......... .......... .......... gland/lesion. 42420................ Excise parotid

20.87 Agree............... 20.87

X .......... .......... .......... .......... .......... gland/lesion. 42440................ Excise

7.05 Agree...............

7.05

X .......... .......... .......... .......... .......... submaxillary gland. 45170................ Excision of

CPT Agree............... 12.48

X .......... .......... .......... .......... .......... rectal lesion. 47525................ Change bile duct

1.54 Agree...............

1.54 ..........

X .......... .......... .......... .......... catheter. 49420................ Insert abdom

CPT Agree...............

2.22

X .......... .......... .......... .......... .......... drain, temp. 49421................ Insert abdom

CPT Agree...............

5.87

X .......... .......... .......... .......... .......... drain, perm. 49507................ Prp i/hern init

9.97 Agree...............

9.97

X .......... .......... .......... .......... .......... block > 5 yr. 49521................ Rerepair ing

12.36 Agree............... 12.36

X .......... .......... .......... .......... .......... hernia, blocked. 49587................ Rpr umbil hern,

7.96 Agree...............

7.96

X .......... .......... .......... .......... .......... block > 5 yr. 50605................ Insert ureteral

CPT Agree............... 16.66 .......... .......... .......... .......... ..........

X support. 51102................ Drain bl w/cath

2.70 Agree...............

2.70

X .......... .......... .......... .......... .......... insertion. 51726................ Complex

CPT Agree...............

1.71 .......... .......... .......... ..........

X .......... cystometro- gram. 51772................ Urethra pressure

CPT Agree...............

1.61 .......... .......... .......... ..........

X profile. 51795................ Urine voiding

CPT Agree...............

1.53 .......... .......... .......... ..........

X .......... pressure study. 51797................ Intra-abdominal

CPT Agree...............

0.80 .......... .......... .......... ..........

X .......... pressure test. 52341................ Cysto w/ureter

5.35 Agree...............

5.35

X .......... .......... .......... .......... .......... stricture tx. 52342................ Cysto w/up

5.85 Agree...............

5.85

X .......... .......... .......... .......... .......... stricture tx. 52343................ Cysto w/renal

6.55 Agree...............

6.55

X .......... .......... .......... .......... .......... stricture tx. 52344................ Cysto/uretero,

7.05 Agree...............

7.05

X .......... .......... .......... .......... .......... stricture tx. 52345................ Cysto/uretero w/

7.55 Agree...............

7.55

X .......... .......... .......... .......... .......... up stricture. 52346................ Cystouretero w/

8.58 Agree...............

8.58

X .......... .......... .......... .......... .......... renal strict. 52400................ Cystouretero w/

8.66 Agree...............

8.66

X .......... .......... .......... .......... .......... congen repr. 52500................ Revision of

7.99 Agree...............

7.99

X .......... .......... .......... .......... .......... bladder neck. 52640................ Relieve bladder

4.73 Agree...............

4.73

X .......... .......... .......... .......... .......... contracture. 53445................ Insert uro/ves

15.21 Agree............... 15.21

X .......... .......... .......... .......... .......... nck sphincter. 54405................ Insert multi-comp 14.39 Agree............... 14.39

X .......... .......... .......... .......... .......... penis pros. 54410................ Remove/replace

15.00 Agree............... 15.00

X .......... .......... .......... .......... .......... penis prosth.

Page 69887

54530................ Removal of testis

8.35 Agree...............

8.35

X .......... .......... .......... .......... .......... 55866................ Lapro radical

CPT Agree............... 32.25 .......... ..........

X .......... ..........

X prostetectomy. 56620................ Partial removal

7.35 Agree...............

7.35

X .......... .......... .......... .......... .......... of vulva. 57155................ Insert uteri

CPT Agree...............

6.79

X .......... .......... .......... .......... .......... tandems/ovoids. 57287................ Revise/remove

10.97 Agree............... 10.97

X .......... .......... .......... .......... .......... sling repair. 57288................ Repair bladder

12.00 Agree............... 12.00 .......... ..........

X .......... .......... .......... defect. 60220................ Partial removal

12.29 Agree............... 12.29

X .......... .......... .......... .......... .......... of thyroid. 60225................ Partial removal

14.67 Agree............... 14.67

X .......... .......... .......... .......... .......... of thyroid. 61885................ Insrt/redo

7.37 Agree...............

7.37

X .......... .......... .......... .......... .......... neurostim 1 array. 62263................ Epidural lysis

6.41 Agree...............

6.41

X .......... .......... .......... .......... .......... mult sessions. 62350................ Implant spinal

6.00 Agree...............

6.00

X .......... .......... .......... .......... .......... canal cath. 62355................ Remove spinal

4.30 Agree...............

4.30

X .......... .......... .......... .......... .......... canal catheter. 62360................ Insert spine

4.28 Agree...............

4.28

X .......... .......... .......... .......... .......... infusion device. 62361................ Implant spine

5.60 Agree...............

5.60

X .......... .......... .......... .......... .......... infusion pump. 62362................ Implant spine

6.05 Agree...............

6.05

X .......... .......... .......... .......... .......... infusion pump. 62365................ Remove spine

4.60 Agree...............

4.60

X .......... .......... .......... .......... .......... infusion device. 63075................ Neck spine disk

CPT Agree............... 19.47 .......... .......... .......... ..........

X .......... surgery. 63650................ Implant

7.15 Agree...............

7.15

X .......... .......... .......... .......... .......... neuroelectrodes. 63660................ Revise/remove

CPT Agree...............

6.87

X .......... .......... .......... ..........

X neuroelectrode. 63685................ Insrt/redo spine

6.00 Agree...............

6.00

X .......... .......... .......... .......... .......... n generator. 63688................ Revise/remove

5.25 Agree...............

5.25

X .......... .......... .......... .......... .......... neuroreceiver. 64416................ N block cont

CPT Agree...............

3.85

X .......... .......... .......... .......... .......... infuse, B plex. 64446................ N block inj,

CPT Agree...............

3.61

X .......... .......... .......... ..........

X sciatic, cont inf. 64448................ N block inj, fem,

CPT Agree...............

3.36

X .......... .......... .......... ..........

X cont inf. 64449................ N block inj,

CPT Agree...............

3.24

X .......... .......... .......... .......... .......... lumbar plexus. 64470................ Inj paravertebral

CPT Agree...............

1.85 .......... .......... .......... .......... ..........

C/T. 64472................ Inj paravertebral

CPT Agree...............

1.29 .......... .......... .......... .......... ..........

C/T add on. 64475................ Inj paravertbral

CPT Agree...............

1.41 .......... .......... .......... .......... ..........

L/S. 64476................ Inj paravertbral

CPT Agree...............

0.98 .......... .......... .......... .......... ..........

L/S add on. 64483................ Inj foramen

CPT Agree...............

1.90 .......... .......... .......... .......... ..........

X epidural l/s. 64484................ Inj foramen

CPT Agree...............

1.33 .......... .......... .......... .......... ..........

X epidural add-on.

Page 69888

64555................ Implant

CPT Agree...............

2.29 .......... .......... .......... .......... ..........

X neuroelectrodes. 64573................ Implant

8.15 Agree...............

8.15

X .......... .......... .......... .......... .......... neuroelectrodes. 64581................ Implant

CPT Agree............... 14.15

X .......... .......... .......... .......... .......... neuroelectrodes. 64622................ Destr

CPT Agree...............

3.02 .......... .......... .......... .......... ..........

X paravertebrl nerve l/s. 64623................ Destr

CPT Agree...............

0.99 .......... .......... .......... .......... ..........

X paravertebral n add-on. 64626................ Destr

CPT Agree...............

3.82 .......... .......... .......... .......... ..........

X paravertebrl nerve c/t. 64627................ Destr

CPT Agree...............

1.16 .......... .......... .......... .......... ..........

X paravertebral n add-on. 64708................ Revise arm/leg

6.22 Agree...............

6.22

X .......... .......... .......... .......... .......... nerve. 64712................ Revision of

CPT Agree...............

7.98

X .......... .......... .......... .......... .......... sciatic nerve. 64831................ Repair of digit

9.00 Agree...............

9.00

X .......... .......... .......... .......... .......... nerve. 65285................ Repair of eye

14.43 Agree............... 14.43

X .......... .......... .......... .......... .......... wound. 66982................ Cataract surgery, 14.83 Agree............... 14.83 ..........

X .......... .......... .......... .......... complex. 67210................ Treatment of

CPT Agree...............

9.35 ..........

X .......... .......... .......... .......... retinal lesion. 67220................ Treatment of

CPT Agree............... 14.19 ..........

X .......... .......... .......... .......... choroid lesion. 67225................ Eye photodynamic

0.47 Agree...............

0.47 .......... ..........

X .......... .......... .......... ther add-on. 67228................ Treatment of

CPT Agree............... 13.67 ..........

X .......... .......... .......... .......... retinal lesion. 68810................ Probe

2.09 Agree...............

2.09

X .......... .......... .......... .......... .......... nasolacrimal duct. 69930................ Implant cochlear

17.60 Agree............... 17.60

X .......... .......... .......... .......... .......... device. 72192................ Ct pelvis w/o dye

CPT Agree...............

1.09 .......... .......... .......... .......... ..........

X 72194................ Ct pelvis w/o & w/

CPT Agree...............

1.22 .......... .......... .......... ..........

X dye. 74170................ Ct abdomen w/o &

CPT Agree...............

1.40 .......... .......... .......... ..........

X .......... w/dye. 74175................ Ct angio abdom w/

CPT Agree...............

1.90 .......... .......... .......... .......... ..........

X o & w/dye. 75790................ Visualize A-V

CPT Agree...............

1.84 .......... .......... .......... ..........

X .......... shunt. 75992................ Artherectomy, X-

CPT Agree...............

0.54 .......... .......... .......... .......... ..........

Ray exam. 75993................ Artherectomy, X-

CPT Agree...............

0.36 .......... .......... .......... .......... ..........

Ray exam. 75994................ Artherectomy, X-

CPT Agree...............

1.31 .......... .......... .......... .......... ..........

Ray exam. 75995................ Artherectomy, X-

CPT Agree...............

1.31 .......... .......... .......... .......... ..........

Ray exam. 75996................ Artherectomy, X-

CPT Agree...............

0.36 .......... .......... .......... .......... ..........

Ray exam. 76513................ Echo exam of eye,

CPT Agree...............

0.66 .......... .......... .......... .......... ..........

X water bath.

Page 69889

77427................ Radiation tx

CPT Agree...............

3.70

X .......... .......... .......... .......... .......... management, x5. 77782................ High intensity

CPT Agree...............

2.04 .......... .......... .......... .......... ..........

X brachytherapy. 78465................ Heart image (3d),

CPT Agree...............

1.46 .......... .......... .......... ..........

X .......... multiple. 78478................ Heart wall motion

CPT Agree...............

0.50 .......... .......... .......... ..........

X .......... add-on. 78480................ Heart function

CPT Agree...............

0.30 .......... .......... .......... ..........

X .......... add-on. 78483................ Heart, first

CPT Agree...............

1.47 .......... .......... .......... .......... ..........

X pass, multiple. 92270................ Electro-

CPT Agree...............

0.81 .......... .......... ..........

X .......... oculography. 92541................ Spontaneous

CPT Agree...............

0.40 .......... .......... .......... ..........

X .......... nystagmus test. 92542................ Positional

CPT Agree...............

0.33 .......... .......... .......... ..........

X .......... nystagmus test. 92544................ Optokinetic

CPT Agree...............

0.26 .......... .......... .......... ..........

X .......... nystagmus test. 92545................ Oscillating

CPT Agree...............

0.23 .......... .......... .......... ..........

X .......... tracking test. 92557................ Comprehensive

CPT Agree...............

0.60 .......... .......... .......... ..........

X .......... hearing test. 92567................ Tympanometry.....

CPT Agree...............

0.20 .......... .......... .......... ..........

X .......... 92568................ Acoustic refl

CPT Agree...............

0.29 .......... .......... .......... ..........

X .......... threshold tst. 92569................ Acoustic reflex

CPT Agree...............

0.20 .......... .......... .......... ..........

X .......... decay test. 92620................ Auditory

1.50 Agree...............

1.50 .......... .......... ..........

X .......... .......... function, 60 min. 92621................ Auditory

0.35 Agree...............

0.35 .......... .......... ..........

X .......... .......... function, + 15 min. 92625................ Tinnitus

1.15 Agree...............

1.15 .......... .......... ..........

X .......... .......... assessment. 92626................ Eval aud rehab

1.40 Agree...............

1.40 .......... .......... ..........

X .......... .......... status. 92627................ Eval aud status

0.33 Agree...............

0.33 .......... .......... ..........

X .......... .......... rehab add-on. 92640................ Aud brainstem

1.76 Agree...............

1.76 .......... .......... ..........

X .......... .......... implt programg. 93236................ ECG monitor/

CPT Agree...............

0.00 .......... .......... .......... .......... ..........

X report, 24 hours. 93350................ Echo

1.46 Agree...............

1.46

X .......... .......... .......... .......... .......... transthoracic. 93526................ Rt & Lt heart

CPT Agree...............

5.98 .......... .......... .......... ..........

X .......... catheters. 93539................ Injection,

CPT Agree...............

0.40 .......... .......... .......... ..........

X .......... cardiac cath. 93540................ Injection,

CPT Agree...............

0.43 .......... .......... .......... ..........

X .......... cardiac cath. 93543................ Injection for

CPT Agree...............

0.29 .......... .......... .......... ..........

X .......... heart x-rays. 93544................ Injection for

CPT Agree...............

0.25 .......... .......... .......... ..........

X .......... aortography. 93545................ Inject for

CPT Agree...............

0.40 .......... .......... .......... ..........

X .......... coronary x-rays. 93555................ Imaging, cardiac

CPT Agree...............

0.81 .......... .......... .......... ..........

X .......... cath. 93556................ Imaging, cardiac

CPT Agree...............

0.83 .......... .......... .......... ..........

X .......... cath. 93620................ Electrophysiology

CPT Agree............... 11.57 .......... .......... .......... ..........

X .......... evaluation. 93621................ Electrophysiology

CPT Agree...............

2.10 .......... .......... .......... ..........

X .......... evaluation.

Page 69890

94681................ Exhaled air

CPT Agree...............

0.20 .......... .......... .......... .......... ..........

X analysis, o2/co2. 97802................ Medical

0.53 Agree...............

0.53 .......... .......... .......... ..........

X .......... nutrition, indiv, in. 97803................ Med nutrition,

0.45 Agree...............

0.45 .......... .......... .......... ..........

X .......... indiv, subseq.

G0179................ MD

CPT Agree...............

0.45 .......... .......... .......... .......... ..........

X recertification

HHA PT.

G0181................ Home health care

CPT Agree...............

1.73 .......... .......... .......... .......... ..........

X supervision.

Note: The RUC reviewed and recommended work RVUs for 6 audiology codes (CPT codes 92620, 92621, 92625, 92626, 92627, and 92640) with which we have agreed. Under Medicare, audiology services are provided under the diagnostic test benefit. We recognize that some of the work descriptors include ``counseling,'' ``the potential for remediation,'' and the establishment of ``interventional goals.'' We do not believe those aspects fit within the diagnostic test benefit but are interested in receiving comments on this issue.

V. Refinement of Relative Value Units for Calendar Year 2009 and

Response to Public Comments on Interim Relative Value Units for 2008

A. Summary of Issues Discussed Related to the Adjustment of Relative

Value Units

Sections IV.B. and IV.C. of this final rule with comment describe the methodology used to review the comments received on the RVUs for physician work and the process used to establish RVUs for new and revised CPT codes. Changes to the RVUs and billing status codes reflected in Addendum B are effective for services furnished beginning

January 1, 2009.

B. Process for Establishing Work Relative Value Units for the Physician

Fee Schedule

The CY 2008 PFS final rule with comment period (72 FR 66365) contained the work RVUs for Medicare payment for existing procedure codes under the PFS and interim RVUs for new and revised codes beginning January 1, 2008. We considered the RVUs for the interim codes to be subject to public comment under the annual refinement process. In this section, we address comments on the interim work RVUs published in the CY 2008 PFS final rule with comment period, and our establishment of the work RVUs for new and revised codes for the CY 2009 PFS.

C. Interim 2008 Codes 1. Orthopedic Fracture Treatment Codes

Orthopedic fracture treatment codes were originally part of the third 5-Year Review of work RVUs. The codes were referred by the AMA

RUC to the AMA's CPT Editorial Panel for further clarification because it was unclear whether the previous valuation for these codes included the circumstance when both internal and external fixation is applied to the fracture site. The CPT Editorial Panel agreed the codes needed further clarification and removed the reference relating to external fixation from the codes.

As a result, the AMA RUC examined the various families of fracture codes and recommended increased work RVUs for most of the codes. The codes were submitted to CMS as part of the new and revised codes for CY 2008. Although we agreed with the work RVU recommendations and rank order listing of the codes in each family, the increase in valuation of the services created BN issues within certain fracture code families.

In order to retain BN within these families of codes, the work RVUs associated with each code were adjusted. That is, the work RVUs were adjusted so that the sum of the new or revised work RVUs (weighted by projected frequency of use) for each family would be the same as the sum of the current work RVUs (weighted by projected frequency of use) for each family of codes.

Comment: Some commenters believed these codes should have been considered as part of the 5-Year review process and the increase in work RVUs should have been absorbed through the BN work adjuster. The commenters also disagreed with the application of BN and noted that this created rank order anomalies. The commenters requested that if BN is applied, it should be implemented across the entire fracture family of codes, which would include codes that have not been surveyed

(Harvard valued codes).

Response: The commenters did not submit sufficient information to demonstrate that the application of BN created rank order anomalies for these codes. We note that the base codes for each fracture family of codes could be submitted to the AMA RUC for re-valuation. This would enable the codes within the family, several of which have not undergone an AMA RUC review, to be properly aligned in comparison to the base codes within each family. 2. Cardiac MRI Codes

For CY 2008, the CPT Editorial Panel created eight new Cardiac

Magnetic Resonance Imaging (MRI) codes and deleted five existing

Cardiac MRI codes due to technological changes and advances in MRI scanning. We established a national noncoverage determination (NCD) for

MRI when blood flow velocity measurement is a component, or comprises all, of the service. As a result, we assigned a status indicator of

``N'' (Noncovered) to four of the new CPT codes (75558, 75560, 75562, and 75564).

Comment: Some commenters expressed disappointment that these four new MRI codes were designated as noncovered and stated that they did not believe the existing NCD for MRI is applicable to flow and velocity measurements.

Response: We have reviewed the information submitted by the commenters and the national noncoverage determination. We have determined that the existing NCD for MRI is applicable to these codes because blood flow/velocity quantification is considered to be a component of these services, which according to the NCD is not considered reasonable and

Page 69891

necessary, and therefore, is noncovered. Any changes in coverage would have to occur through the NCD process. 3. Non-Face-to-Face Physician and Qualified Healthcare Professional

Services

For CY 2008, the CPT Editorial Panel created eight new codes (CPT codes 98966, 98967, 98968, 98969, 99441, 99442, 99443, and 99444) to describe Evaluation and Management (E/M) services furnished by a physician or qualified healthcare professional via telephone or online, for which the AMA RUC and the AMA's Health Care Professionals Advisory

Committee provided work and PE valuations. We assigned a status indicator of ``N'' (Noncovered) to these services because: (1) These services are non-face-to-face; and (2) the code descriptors include language that recognizes the provision of services to parties other than the beneficiary for whom Medicare does not provide coverage (for example, a guardian).

Comment: Some commenters requested that we reconsider the assignment of an N status for these codes. The commenters believed that failure to provide incentives and funding for these codes affects the alignment of quality of care between providers.

Response: We have considered the commenters' request. However, we will continue to recognize these services as noncovered because they are not furnished in a face-to-face setting (nor are they furnished as

Medicare telehealth services), and the code descriptors include language that recognizes the provision of services to a noncovered entity.

In the CY 2008 PFS final rule with comment period (73 FR 66371), we also responded to the AMA RUC recommendations on the PE inputs for the new and revised CPT codes for 2008. In addition to the PE comments discussed in section II.A.2. of this final rule with comment period, we received the following comments concerning PE inputs:

Comment: The specialty societies and the AMA RUC provided clarification and pricing information concerning direct PE inputs for

CPT Code 43760, Change of gastrostomy tube, percutaneous, without imaging or endoscopic guidance.

Response: We have revised the PE database to reflect this information.

Comment: Several commenters questioned the PE RVUs for CPT code 68816, Probing of nasolacrimal duct, with or without irrigation; with transluminal balloon catheter dilation, believing it to be undervalued.

In particular, one commenter stated that the payment for this service is less than a specific supply item.

Response: We have reviewed the PE inputs for this service and determined that they accurately represent the inputs recommended by the

AMA RUC. The difference in the actual costs of the direct PE inputs and the payment amount for this service is due to the application of the uniform BN adjustment that is applied to all direct inputs as part of the bottom-up PE methodology.

D. Establishment of Interim Work Relative Value Units for New and

Revised Physician's Current Procedural Terminology (CPT) Codes and New

Healthcare Common Procedure Coding System Codes (HCPCS) for 2009

(Includes Table Titled ``AMA RUC Recommendations and CMS' Decisions for

New and Revised 2009 CPT Codes'')

One aspect of establishing RVUs for 2008 was to assign interim work

RVUs for all new and revised CPT codes. As described in our November 25, 1992 notice on the 1993 PFS (57 FR 55951) and in section III.B. of the CY 1997 PFS final rule (61 FR 59505), we established a process, based on recommendations received from the AMA RUC, for establishing interim work RVUs for new and revised codes.

We received work RVU recommendations for 128 new and revised CPT codes from the AMA RUC this year. We reviewed the AMA RUC recommendations by comparing them to our reference set or to other comparable services for which work RVUs had previously been established. We also considered the relationships among the new and revised codes for which we received AMA RUC recommendations and agreed with the majority of the relative relationships reflected in the AMA

RUC values. Table 27: AMA RUC Recommendations and CMS' Decisions for

New and Revised 2009 CPT Codes lists the new or revised CPT codes, and their associated work RVUs, that will be interim in CY 2009. Table 27 includes the following information:

A ``'' identifies a new code for CY 2009.

CPT code. This is the CPT code for a service.

Modifier. A ``26'' in this column indicates that the work

RVUs are for the PC of the code.

Description. This is an abbreviated version of the narrative description of the code.

AMA RUC recommendations. This column identifies the work

RVUs recommended by the AMA RUC.

CMS decision. This column indicates whether we agreed or we disagreed with the AMA RUC recommendation. Codes for which we did not accept the AMA RUC recommendation are discussed in greater detail following this table. 2009 Work RVUs. This column establishes the interim 2009 work RVUs for physician work.

Table 27--AMA RUC Recommendations and CMS' Decisions for New and Revised 2009 CPT Codes

AMA RUC work

CPT \1\ code

Mod

Descriptor

RVU

CMS decision

2009 WRVU recommendation

20696........

* ..... COMP MULTIPLANE

17.32 Agree................

17.32

EXT FIXATION. 20697........

* ..... COMP EXT FIXATE

0.00 Agree................

0.00

STRUT CHANGE. 22856........

* ..... CERV ARTIFIC

23.90 Agree................

23.90

DISKECTOMY. 22861........

* ..... REVISE CERV

33.21 Agree................

33.21

ARTIFIC DISC. 22864........

* ..... REMOVE CERV ARTIF

29.25 Agree................

29.25

DISC. 27027........ ...... ..... BUTTOCK FASCIOTOMY

12.90 Agree................

12.90 27057........ ...... ..... BUTTOCK FASCIOTOMY

14.77 Agree................

14.77

W/DBRDMT. 27215................. ...... ..... TREAT PELVIC

10.45 Agree (a)............

10.45

FRACTURE(S). 27216................. ...... ..... TREAT PELVIC RING

15.73 Agree (a)............

15.73

FRACTURE. 27217................. ...... ..... TREAT PELVIC RING

14.65 Agree (a)............

14.65

FRACTURE. 27218................. ...... ..... TREAT PELVIC RING

20.93 Agree (a)............

20.93

FRACTURE. 35535........ ...... ..... ARTERY BYPASS

38.00 Agree................

38.00

GRAFT. 35570........ ...... ..... ARTERY BYPASS

29.00 Agree................

29.00

GRAFT.

Page 69892

35632........ ...... ..... ARTERY BYPASS

36.00 Agree................

36.00

GRAFT. 35633........ ...... ..... ARTERY BYPASS

38.98 Agree................

38.98

GRAFT. 35634........ ...... ..... ARTERY BYPASS

35.20 Agree................

35.20

GRAFT. 41512........ ...... ..... TONGUE SUSPENSION.

6.75 Agree................

6.75 41530........ ...... ..... TONGUE BASE VOL

4.38 Agree................

4.38

REDUCTION. 43273........

* ..... ENDOSCOPIC

2.24 Agree................

2.24

PANCREATOSCOPY. 43279........

* ..... LAP MYOTOMY,

22.00 Agree................

22.00

HELLER. 46930........ ...... ..... DESTROY INTERNAL

1.56 Agree................

1.56

HEMORRHOIDS. 49652........ ...... ..... LAP VENT/ABD

12.80 Agree................

12.80

HERNIA REPAIR. 49653........ ...... ..... LAP VENT/ABD HERN

16.10 Agree................

16.10

PROC COMP. 49654........ ...... ..... LAP INC HERNIA

14.95 Agree................

14.95

REPAIR. 49655........ ...... ..... LAP INC HERN

18.00 Agree................

18.00

REPAIR COMP. 49656........ ...... ..... LAP INC HERNIA

15.00 Agree................

15.00

REPAIR RECUR. 49657........ ...... ..... LAP INC HERN RECUR

22.00 Agree................

22.00

COMP. 55706........

* ..... PROSTATE

6.15 Agree................

6.15

SATURATION

SAMPLING. 61796........ ...... ..... SRS, CRANIAL

15.50 Disagree.............

10.79

LESION SIMPLE. 61797........ ...... ..... SRS, CRAN LES

3.48 Agree................

3.48

SIMPLE, ADDL. 61798........ ...... ..... SRS, CRANIAL

19.75 Disagree.............

10.79

LESION COMPLEX. 61799........ ...... ..... SRS, CRAN LES

4.81 Agree................

4.81

COMPLEX, ADDL. 61800........ ...... ..... APPLY SRS

2.25 Agree................

2.25

HEADFRAME ADD-ON. 62267........ ...... ..... INTERDISCAL PERQ

3.00 Agree................

3.00

ASPIR, DX. 63620........

* ..... SRS, SPINAL LESION

15.50 Disagree.............

10.79 63621........

* ..... SRS, SPINAL

4.00 Agree................

4.00

LESION, ADDL. 64416................. ...... ..... N BLOCK CONT

1.81 Agree................

1.81

INFUSE, B PLEX. 64446................. ...... ..... N BLK INJ,

1.81 Agree................

1.81

SCIATIC, CONT INF. 64448................. ...... ..... N BLOCK INJ FEM,

1.63 Agree................

1.63

CONT INF. 64449................. ...... ..... N BLOCK INJ,

1.81 Agree................

1.81

LUMBAR PLEXUS. 64455........ ...... ..... N BLOCK INJ,

0.75 Agree................

0.75

PLANTAR DIGIT. 64632........ ...... ..... N BLOCK INJ,

1.20 Agree................

1.20

COMMON DIGIT. 65756........ ...... ..... CORNEAL TRNSPL,

16.60 Agree................

16.60

ENDOTHELIAL. 65757........ ...... ..... PREP CORNEAL ENDO

1.44 Disagree.............

(\2\ )

ALLOGRAFT. 77785........ ......

26 HDR BRACHYTX, 1

1.42 Agree................

1.42

CHANNEL. 77786........ ......

26 HDR BRACHYTX, 2-12

3.25 Agree................

3.25

CHANNEL. 77787........ ......

26 HDR BRACHYTX OVER

4.89 Agree................

4.89 12 CHAN. 78808........ ...... ..... IV INJ RA DRUG DX

0.18 Agree................

0.18

STUDY. 90951........ ...... ..... ESRD SERV, 4

18.46 Agree................

18.46

VISITS P MO, 90952........ ...... ..... ESRD SERV, 2-3

(\2\ ) Agree................

(\2\ )

VSTS P MO, 90953........ ...... ..... ESRD SERV, 1 VISIT

(\2\ ) Agree................

(\2\ )

P MO, 90954........ ...... ..... ESRD SERV, 4 VSTS

15.98 Agree................

15.98

P MO, 2-11. 90955........ ...... ..... ESRD SRV 2-3 VSTS

8.79 Agree................

8.79

P MO, 2-11. 90956........ ...... ..... ESRD SRV, 1 VISIT

5.95 Agree................

5.95

P MO, 2-11. 90957........ ...... ..... ESRD SRV, 4 VSTS P

12.52 Agree................

12.52

MO, 12-19. 90958........ ...... ..... ESRD SRV 2-3 VSTS

8.34 Agree................

8.34

P MO 12-19. 90959........ ...... ..... ESRD SERV, 1 VST P

5.50 Agree................

5.50

MO, 12-19. 90960........ ...... ..... ESRD SRV, 4 VISITS

5.18 Agree................

5.18

P MO, 20+. 90961........ ...... ..... ESRD SRV, 2-3 VSTS

4.26 Agree................

4.26

P MO, 20+. 90962........ ...... ..... ESRD SERV, 1 VISIT

3.15 Agree................

3.15

P MO, 20+. 90963........ ...... ..... ESRD HOME PT, SERV

10.56 Agree................

10.56

P MO, 90964........ ...... ..... ESRD HOME PT SERV

9.14 Agree................

9.14

P MO, 2-11. 90965........ ...... ..... ESRD HOME PT SERV

8.69 Agree................

8.69

P MO 12-19. 90966........ ...... ..... ESRD HOME PT, SERV

4.26 Agree................

4.26

P MO, 20+. 90967........ ...... ..... ESRD HOME PT SERV

0.35 Agree................

0.35

P DAY, 90968........ ...... ..... ESRD HOME PT SRV P

0.30 Agree................

0.30

DAY, 2-11. 90969........ ...... ..... ESRD HOME PT SRV P

0.29 Agree................

0.29

DAY 12-19. 90970........ ...... ..... ESRD HOME PT SERV

0.14 Agree................

0.14

P DAY, 20+. 93228........

* ..... REMOTE 30 DAY ECG

0.52 Agree................

0.52

REV/REPORT. 93229........

* ..... REMOTE 30 DAY ECG

0.00 Disagree.............

(\2\ )

TECH SUPP. 93279........

26 PM DEVICE PROGR

0.65 Agree................

0.65

EVAL, SNGL. 93280........

26 PM DEVICE PROGR

0.77 Agree................

0.77

EVAL, DUAL. 93281........

26 PM DEVICE PROGR

0.90 Agree................

0.90

EVAL, MULTI. 93282........

26 ICD DEVICE PROG

0.85 Agree................

0.85

EVAL, 1 SNGL. 93283........

26 ICD DEVICE PROGR

1.18 Disagree.............

1.05

EVAL, DUAL. 93284........

26 ICD DEVICE PROGR

1.25 Agree................

1.25

EVAL, MULT. 93285........

26 ILR DEVICE EVAL

0.52 Agree................

0.52

PROGR. 93286........

26 PRE-OP PM DEVICE

0.30 Agree................

0.30

EVAL. 93287........

26 PRE-OP ICD DEVICE

0.45 Agree................

0.45

EVAL. 93288........

26 PM DEVICE EVAL IN

0.43 Agree................

0.43

PERSON. 93289........

26 ICD DEVICE

0.92 Disagree.............

0.78

INTERROGATE.

Page 69893

93290........

26 ICM DEVICE EVAL...

0.43 Agree................

0.43 93291........

26 ILR DEVICE

0.43 Agree................

0.43

INTERROGATE. 93292........

26 WCD DEVICE

0.43 Agree................

0.43

INTERROGATE. 93293........

26 PM PHONE R-STRIP

0.32 Agree................

0.32

DEVICE EVAL. 93294........

26 PM DEVICE

0.65 Agree................

0.65

INTERROGATE

REMOTE. 93295........

26 ICD DEVICE

1.38 Disagree.............

1.17

INTERROGAT REMOTE. 93296........

* ..... PM/ICD REMOTE TECH

0.00 Agree................

0.00

SERV. 93297........

* ..... ICM DEVICE

0.52 Agree................

0.52

INTERROGAT REMOTE. 93298........

* ..... ILR DEVICE

0.52 Agree................

0.52

INTERROGAT REMOTE. 93299........

* ..... ICM/ILR REMOTE

0.00 Disagree.............

(\2\ )

TECH SERV. 93306........

26 TTE W/DOPPLER,

1.30 Agree................

1.30

COMPLETE. 93351........

* ..... STRESS TTE

1.75 Agree................

1.75

COMPLETE. 93352........

* ..... ADMIN ECG CONTRAST

0.19 Agree................

0.19

AGENT. 95803........

26 ACTIGRAPHY TESTING

1.00 Disagree.............

(\2\ ) 95992........ ...... ..... CANALITH

0.75 Agree (b)............

(\3\ )

REPOSITIONING

PROC. 96360........ ...... ..... HYDRATION IV

0.17 Agree................

0.17

INFUSION, INIT. 96361........ ...... ..... HYDRATE IV

0.09 Agree................

0.09

INFUSION, ADD-ON. 96365........ ...... ..... THER/PROPH/DIAG IV

0.21 Agree................

0.21

INF, INIT. 96366........ ...... ..... THER/PROPH/DIAG IV

0.18 Agree................

0.18

INF ADDON. 96367........ ...... ..... TX/PROPH/DG ADDL

0.19 Agree................

0.19

SEQ IV INF. 96368........ ...... ..... THER/DIAG

0.17 Agree................

0.17

CONCURRENT INF. 96369........ ...... ..... SC THER INFUSION,

0.21 Agree................

0.21

UP TO 1 HR. 96370........ ...... ..... SC THER INFUSION,

0.18 Agree................

0.18

ADDL HR. 96371........ ...... ..... SC THER INFUSION,

0.00 Agree................

0.00

RESET PUMP. 96372........ ...... ..... THER/PROPH/DIAG

0.17 Agree................

0.17

INJ, SC/IM. 96373........ ...... ..... THER/PROPH/DIAG

0.17 Agree................

0.17

INJ, IA. 96374........ ...... ..... THER/PROPH/DIAG

0.18 Agree................

0.18

INJ, IV PUSH. 96375........ ...... ..... TX/PRO/DX INJ NEW

0.10 Agree................

0.10

DRUG ADDON. 96376........ ...... ..... TX/PRO/DX INJ NEW

0.00 Agree................

0.00

DRUG ADON. 96379........ ...... ..... THER/PROP/DIAG INJ/

0.00 Agree................

0.00

INF PROC. 99460........ ...... ..... INIT NB EM PER

1.17 Agree................

1.17

DAY, HOSP. 99461........ ...... ..... INIT NB EM PER

1.26 Agree................

1.26

DAY, NON-FAC. 99462........ ...... ..... SBSQ NB EM PER

0.62 Agree................

0.62

DAY, HOSP. 99463........ ...... ..... SAME DAY NB

1.50 Agree................

1.50

DISCHARGE. 99464........ ...... ..... ATTENDANCE AT

1.50 Agree................

1.50

DELIVERY. 99465........ ...... ..... NB RESUSCITATION..

2.93 Agree................

2.93 99466........ ...... ..... PED CRIT CARE

4.79 Agree................

4.79

TRANSPORT. 99467........ ...... ..... PED CRIT CARE

2.40 Agree................

2.40

TRANSPORT ADDL. 99468........ ...... ..... NEONATE CRIT CARE,

18.46 Agree................

18.46

INITIAL. 99469........ ...... ..... NEONATE CRIT CARE,

7.99 Agree................

7.99

SUBSQ. 99471........ ...... ..... PED CRITICAL CARE,

15.98 Agree................

15.98

INITIAL. 99472........ ...... ..... PED CRITICAL CARE,

7.99 Agree................

7.99

SUBSQ. 99475........ ...... ..... PED CRIT CARE AGE

11.25 Agree................

11.25 2-5, INIT. 99476........ ...... ..... PED CRIT CARE AGE

6.75 Agree................

6.75 2-5, SUBSQ. 99478........ ...... ..... IC, LBW INF 99479........ ...... ..... IC LBW INF 1500-

2.50 Agree................

2.50 2500 G SUBSQ. 99480........ ...... ..... IC INF PBW 2501-

2.40 Agree................

2.40 5000 G SUBSQ.

New CPT code.

\2\ Medicare Contractor Priced.

\3\ Bundled.

* New Code for Re-Examination at the next 5-Year Review.

(a) See code discussion in section E, Discussion of Codes and RUC Recommendations.

(b) RUC-recommended work RVU accepted but coverage status of code is Bundled.

Table 28: AMA RUC Anesthesia Recommendations and CMS Decisions for

New 2009 CPT Codes lists the new CPT codes for anesthesia and their base units that will be interim in CY 2009. Table 28 includes the following information:

CPT code. This is the CPT code for a service.

Description. This is an abbreviated version of the narrative description of the code.

AMA RUC recommendations. This column identifies the base units recommended by the AMA RUC.

CMS decision. This column indicates whether we agreed or we disagreed with the AMA RUC recommendation. 2009 Base Units. This column establishes the CY 2009 base units for these services.

Page 69894

Table 28--AMA RUC Anesthesia Recommendations and CMS Decisions for New and Revised/Reviewed CPT Codes

RUC

2009 base

*CPT \1\ code

Description

recommendation

CMS decision

units

00211.................... ANESTH, CRAN SURG,

10.00 Agree................

10.00

HEMOTOMA. 00567.................... ANESTH, CABG W/PUMP..

18.00 Agree................

18.00

New CPT code.

E. Discussion of Codes and AMA RUC Recommendations

The following is an explanation of our rationale for not accepting particular AMA RUC-recommended work RVUs. It is arranged by type of service in CPT order and refers only to work RVUs. 1. Pelvic Bone Fracture Codes

For CY 2009, the CPT Editorial Panel revised the following four CPT codes to report pelvic bone fractures as being unilateral, and reportedly, to clarify the nature of ring fractures as follows: 27215, Open treatment of iliac spine(s), tuberosity avulsion, or iliac wing fractures(s), unilateral for pelvic bone fracture patterns which do not disrupt the pelvic ring includes internal fixation, when performed. 27216, Percutaneous skeletal fixation of posterior pelvic bone fracture and/or dislocation, for fracture patterns which disrupt the pelvic ring, unilateral, (includes ipsilateral ilium, sacroiliac joint and/or sacrum). 27217, Open treatment of anterior pelvic bone fracture and/or dislocation for fracture patterns which disrupt the pelvic ring, unilateral includes internal fixation when performed (includes ipsilateral pubic symphysis and/or superior/inferior rami). 27218, Open treatment of posterior pelvic bone fracture and/or dislocation, for fracture patterns which disrupt the pelvic ring, unilateral, includes internal fixation, when performed (includes ipsilateral ilium, sacroiliac joint and/or sacrum.

The AMA RUC reviewed these codes and agreed with the specialty society that revisions to the code descriptors were editorial because these services were previously valued as typically unilateral with internal fixation. The AMA RUC recommended maintaining the current work

RVUs for these codes: 10.45 work RVUs for CPT code 27215; 15.73 work

RVUs for CPT code 27216; 14.65 work RVUs for CPT code 27217; and 20.93 work RVUs for CPT code 27218.

We do not agree with CPT and the AMA RUC that the pelvis is a unilateral structure and that the code descriptor change was editorial.

The pelvis is formed by adjoining the ilium, ischium, pubis, and sacrum together. Clinically, it is a single anatomic entity and has been referenced as a single anatomic entity. We believe the previous code descriptors more accurately describe the structure of the pelvis and subsequent treatment of fractures. Therefore, we created four G codes to be used with pelvic bone fracture repairs that may occur on one side or both sides of the pelvis consistent with CY 2008 descriptors. We believe the following codes represent these services more appropriately:

G0412, Open treatment of iliac spine(s), tuberosity avulsion, or iliac wing fractures(s), unilateral or bilateral for pelvic bone fracture patterns which do not disrupt the pelvic ring includes internal fixation, when performed.

G0413, Percutaneous skeletal fixation of posterior pelvic bone fracture and/or dislocation, for fracture patterns which disrupt the pelvic ring, unilateral or bilateral, (includes ilium, sacroiliac joint and/or sacrum).

G0414, Open treatment of anterior pelvic bone fracture and/or dislocation for fracture patterns which disrupt the pelvic ring, unilateral or bilateral, includes internal fixation when performed

(includes pubic symphysis and/or superior/inferior rami).

G0415, Open treatment of posterior pelvic bone fracture and/or dislocation, for fracture patterns which disrupt the pelvic ring, unilateral or bilateral, includes internal fixation, when performed (includes ilium, sacroiliac joint and/or sacrum).

We have decided to assign the same work RVU values for the G codes as for the corresponding CPT codes: 10.45 work RVUs for G0412; 15.73 work RVUs for G0413; 14.65 work RVUs for G0414; and 20.93 work RVUs for

G0415. For CY 2009, we will not recognize CPT codes 27215, 27216, 27217, and 27218 as covered services under the PFS and have assigned a status indicator of ``I'' (Not valid for Medicare purposes, Medicare recognizes another code). 2. Stereotactic Radiosurgery Codes

The CPT Editorial Panel made a significant revision to the stereotactic radiosurgery codes for cranial and spinal stereotactic radiosurgery (SRS) codes, for which the AMA RUC provided recommended work and PE valuations. For CY 2009, the CPT Editorial Panel deleted

CPT code 61793, Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator), one or more sessions, and created seven new codes for cranial and spinal lesions to replace CPT code 61793. We believe that the deleted CPT code 61793 accurately describes a complete course of stereotactic radiosurgery, inclusive of all lesions and anatomic sites.

Delivery of radiation as a therapeutic modality consists of many components, including planning, physics, dosimetry, simulation, treatment delivery, and management. Regardless of the clinical background or training received by the clinician, we believe the work involved in providing radiation therapy services or radiosurgery radiation therapy is similar, and that the work relative values should be similar. Currently, CPT code 77432, Stereotactic radiation treatment management of cranial lesion(s) (complete course of treatment consisting of one session), with 7.92 work RVUs, is used by providers when managing certain pre- and post-delivery-related services of stereotactic radiation. CPT code 77432 includes treatment-related services of all cranial lesions during one session. We have been informed that CPT code 77421, Stereoscopic X-ray guidance for localization of target volume for the delivery of radiation therapy, with 0.39 work RVUs, often is used, in association with CPT code 77432, when appropriate.

The specialty societies and the AMA RUC, in general, used open surgical codes as comparators during the RUC process. For example, for

CPT code 61797, the comparison code was CPT code 63048, Laminectomy, facetectomy and foraminotomy (unilateral or bilateral with decompression of spinal cord, cauda equina and/or nerve root[s], [eg, spinal or lateral recess stenosis]),

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single vertebral segment; each additional segment, cervical, thoracic, or lumbar (List separately in addition to code for primary procedure), instead of a more equivalent stereotactic radiation treatment code.

Therefore, we disagree with the work RVUs for the following CPT codes: 61796, Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); 1 simple cranial lesion; 61797, Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); each additional cranial lesion, simple; 61798, Stereotactic radiosurgery

(particle beam, gamma ray, or linear accelerator); 1 complex cranial lesion; 61799, Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); each additional cranial lesion, complex; 63620,

Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); 1 spinal lesion; and 63621, Stereotactic radiosurgery

(particle beam, gamma ray, or linear accelerator); each additional spinal lesion.

We believe that the more appropriate comparison for the replacement codes for CPT code 61793 is with CPT codes 77432 plus 77421. The AMA

RUC recommended that CPT codes 61796, 61798, and 63620 include a half- day discharge day and two 99213 office visits. We include those recommended values within our valuation of these services.

Therefore, the new work values for these codes would be as follows: 10.79 work RVUs for CPT codes 61796, 61798, and 63620. For the add-on

CPT codes 61797, 61799, and 63621, the specialty societies and the AMA

RUC used open surgical codes as comparison codes. As noted above, we do not believe that such codes provide the correct comparison, which led to an inappropriate valuation of these codes. Although we disagree with the methodology and valuation of the add-on codes, we will accept the values as recommended on an interim basis. We urge the AMA RUC, to the extent that the type of specialty involved played a part in the valuation of these codes, to place an emphasis on the type of work performed, not the specialty provider. 3. Endothelial Keratoplasty

The CPT Editorial Panel created two CPT codes (65756, Keratoplasty

(corneal transplant); endothelial and 65757, Backbench preparation of corneal endothelial allograft prior to transplantation (List separately in addition to code for primary procedure) to describe the physician service of endothelial keratoplasty, which is a new surgical method of repairing certain types of diseased corneas that in the past would have required a full thickness corneal transplant (also called penetrating keratoplasty). The AMA RUC recommended 16.60 work RVUs for CPT code 65756 and 1.44 work RVUs for CPT code 65757. We have accepted the AMA

RUC recommended work RVUs for CPT code 65756; however, we have decided to have Medicare contractors price CPT code 65757. We recognize that it is difficult to assess the intensity and work of the other backbench transplant codes and have generally contractor priced them. We also recognize that this service is one of short duration and high intensity. The intra-service work per unit time (IWPUT) may not be of the greatest accuracy in evaluating this service. 4. Cardiac Monitoring

The CPT Editorial Panel made significant revisions to the cardiac device monitoring (CDM) codes, for which the AMA RUC provided work and

PE valuations. The CDM codes describe services that generally fall into three categories: Interrogation of devices (retrieval and evaluation of stored device data); programming of devices (retrieval and evaluation of stored device data and programming of the device); and remote monitoring of devices (solely technical services for monitoring, basic analysis and assemblage of device data).

We agree with the majority of the AMA RUC-recommended valuations.

However, we question the recommended values of the increments between some codes within families and across families of pacemakers, implantable cardioverter defibrillators (ICDs), implantable loop recorders, and implantable cardiovascular monitoring systems. CPT codes 93279 through 93281 (0.65 to 0.90 work RVUs, with a work RVU difference between the codes of 0.12 to 0.13) describe the programming of pacemakers according to the number of leads. CPT codes 93282 through 93284 (0.85 to 1.25 work RVUs, with a work RVU difference between the codes of 0.07 to 0.33) describe the programming of ICDs according to the number of leads. We note that the recommended difference in the work RVUs between CPT code 93279 (single lead programming pacemaker code) and CPT code 93282 (single lead ICD code) is 0.20 work RVUs, and that the difference between CPT code 93281 (multiple lead programming pacemaker code) and CPT code 93284 (multiple lead ICD code) is 0.35 work RVUs. The AMA RUC primarily used a comparison methodology to determine the value of the pacemaker codes and the surveyed 25th percentile to determine the value of the implantable cardioverter defibrillator (ICD) codes. Even though different methodologies were utilized to develop the recommended values, we do not understand why the increments between various levels of the pacemaker programming codes are not also the appropriate increment between the various levels of ICD programming codes. Therefore, we are not accepting these recommendations and instead will establish work RVUs that maintain the same incremental difference between levels of programming codes. This change will help to ensure consistency and relativity within all cardiac device monitoring codes. The specific changes to the codes are discussed below.

In addition, we believe that although the surveyed 25th percentile of 1.18 work RVUs was chosen for valuation of CPT code 93283, the increment of 0.33 work RVUs between CPT codes 93282 and 93283 is excessive. Therefore, we believe that the appropriate value for CPT code 93283 is 1.05 work RVUs, slightly below the 25th percentile. We believe that an appropriate comparison CPT code for 93283 is CPT code 93890 (Transcranial Doppler study of the intracranial arteries; vasoreactivity study) which has a work RVU of 1.00. CPT code 93286

(0.30 work RVUs) describes periprocedural programming of a pacemaker.

CPT code 93287 (0.45 work RVUs) describes periprocedural programming of an ICD. These codes have recommended work RVU differences of 0.15 work

RVUs and 0.30 work RVUs between the pacemakers and ICDs for a single service and for services pre- and postsurgery, respectively. CPT code 93288 (0.43 work RVUs) describes in person interrogation of pacemakers.

CPT Code 93289 (0.92 work RVUs, which was developed by means of a crosswalk to a 99213 office visit) describes in person interrogation of an ICD, a work RVU difference of 0.49 RVUs between the pacemakers and

ICDs.

As noted above, the work RVU difference between programming pacemakers and ICDs varies from 0.20 to 0.35. Therefore, we believe that the appropriate value for CPT code 93289 should be 0.78 (0.43 (the work value of CPT code 93288) plus 0.35 (the largest difference between pacemaker and ICD programming codes families)). Appropriate comparisons are CPT codes 99231 (Subsequent hospital care) which has a work RVU of 0.76, and CPT code 93015 (Cardiovascular stress test using maximal or submaximal treadmill or bicycle exercise, continuous electrocardiographic monitoring, and/or

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pharmacological stress; with physician supervision, with interpretation and report) which has a work RVU of 0.75. Therefore, we believe a work

RVU of 0.78 is appropriate for CPT code 93289.

The AMA RUC-recommended work RVUs of 0.65 for CPT code 93294,

Interrogation device evaluation(s) (remote), up to 90 days; single, dual, or multiple lead pacemaker system with interim physician analysis, review(s) and report(s), was determined by multiplying 1.5

(the average number of transmissions per 90 days) times the work RVU for CPT code 93288 (0.43). The AMA RUC-recommended work RVUs of 1.38 for CPT code 93295, Interrogation device evaluation(s) (remote), up to 90 days; single, dual, or multiple lead pacemaker system with interim physician analysis, review(s) and report(s), was determined by multiplying 1.5 (the average number of transmissions per 90 days) times the work RVU for CPT code 93289 (0.92). Because we are adjusting the work value for CPT code 93289 to 0.78, using the RUC-recommended methodology, the adjusted work value for CPT code 93295 is 1.17.

We note that certain CDM codes were not reviewed by the RUC. For example, CPT codes 93230, Wearable electrocardiographic rhythm derived monitoring for 24 hours by continuous original waveform recording and storage without superimposition scanning utilizing a device capable of producing a full miniaturized printout; includes recording, microprocessor-based analysis with report, physician review and interpretation, and 93233, Wearable electrocardiographic rhythm derived monitoring for 24 hours by continuous original waveform recording and storage without superimposition scanning utilizing a device capable of producing a full miniaturized printout; physician review and interpretation, currently have work RVUs of 0.52 each. Some of the newly valued CDM codes that provide payment for 30 days of work (for example, CPT codes 93268, Wearable patient activated electrocardiographic rhythm derived event recording with presymptom memory loop, 24-hour attended monitoring, per 30 day period of time; includes transmission, physician review and interpretation, and 93272,

Wearable patient activated electrocardiographic rhythm derived event recording with presymptom memory loop, 24-hour attended monitoring, per 30 day period of time; physician review and interpretation, also have work RVUs of 0.52. We urge the AMA RUC to assess the work valuation of

CPT codes 93230 and 93233 in the future in light of the valuation of the other new similar codes.

The adjusted work RVUs are as follows: 1.05 work RVUs for CPT code 93283; 0.78 work RVUs for CPT code 93289; and 1.17 work RVUs for CPT code 93295. 5. Mobile Cardiovascular Telemetry and Implantable Loop Monitoring

The CPT Editorial Panel created two new codes 93228 and 93229 for mobile cardiovascular telemetry and a new code 93299 related to implantable cardiovascular monitoring systems or implantable loop recorder systems. The AMA RUC recommended 0.52 work RVUs for CPT code 93228 and only direct cost inputs for CPT code 93229 and 93299. These services were previously billed using unlisted codes, which were contractor priced. CPT code 93228 represents the professional aspect of the mobile cardiovascular telemetry service and CPT code 93229 represents the technical aspect. We have accepted the AMA RUC recommended work RVUs for CPT code 93228. However, we will continue to contractor price CPT codes 93229 and 93299 in order to provide additional time to better understand the direct cost inputs for this service and to allow us to collect actual utilization data under the new code. 6. Canalith Repositioning

The CPT Editorial Panel created and the AMA RUC valued a new code

(CPT code 95992, Canalith repositioning procedure(s) (eg, Epley maneuver, Semont maneuver), per day) for canalith repositioning, which is described as ``therapeutic maneuvering of the patients' body and head designed to use the force of gravity. By using this type of maneuvering, the calcium crystal debris that is in the semi-circular canal system is redeposited into a neutral part of the end organ where it will not cause vertigo.'' This is a procedure that has been performed for several years. Previously this maneuver was billed by physicians as part of an E&M service and by nonphysician practitioners, primarily therapists, under a number of CPT codes, including 97112,

Therapeutic procedure, one or more areas, each 15 minutes; neuromuscular reeducation of movement, balance, coordination, kinesthetic sense, posture, and/or proprioception for sitting and/or standing activities, which has 0.45 work RVUs. Therapists usually bill 2 units of service. The RUC recommended work RVUs for this service is 0.75.

We believe a status indicator of ``B'' (Bundled Code, payments for covered services are always bundled into payment for other services not specified) is most appropriate because this service is currently being paid for as part of an E&M service. (Note: Because neurologists and physical therapists are the predominant providers of this service to

Medicare patients (each at 22 percent) it has been assigned as a

``sometimes therapy'' service under the therapy code abstract file.)

F. Additional Coding Issues 1. Reduction in the Technical Component (TC) Payment for Imaging

Services Paid Under the PFS to the Outpatient Department (OPD) Amount

Effective January 1, 2007, section 5102(b)(1) of the Deficit

Reduction Act of 2005 (Pub. L. 109-171) (DRA) capped the TC of most imaging services paid under the PFS to the amount paid under the

Outpatient Prospective Payment System (OPPS) (71 FR 69659).

The list of codes subject to of OPPS cap has been revised to reflect new and deleted CPT codes for 2009. CPT Codes 78890 and 78891 have been deleted and have been removed from the list. The following new CPT codes have been added to the list: 93306, Echocardiography, transthoracic real-time with image documentation (2D), including M-mode recording if performed, with spectral Doppler echocardiography, and with color flow Doppler echocardiography.

The complete list of codes subject to the OPPS cap is in Addendum

I. 2. Moderate (Conscious) Sedation Codes (CPT Codes 99143 to 99150)

In 2006, the moderate sedation codes were adopted by the CPT. We did not accept the AMA RUC-recommended work values for these codes, but stated that they would be contractor priced under the PFS. At that time, we indicated that we would continue to review this issue.

In August 2008, the AMA RUC convened a workgroup to review the moderate sedation codes. The workgroup examined national claims data provided to them by CMS to determine if any further action was necessary for these codes. The workgroup concluded its work in

September 2008. It recommended that CMS again consider assigning the previously AMA RUC-recommended work values to both the pediatric and adult moderate sedation codes.

Comment: Although not specifically discussed in the CY 2009 PFS proposed rule, we received comments concerning the pricing of these codes. Commenters requested that CMS assign the status

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indicator of ``A'' to these codes under the PFS Database and include the AMA RUC-recommended RVUs for these codes. Another commenter requested that we implement the AMA RUC recommendations for the pediatric conscious sedation codes which are represented by CPT codes 99143 and 99150.

Response: When these codes were established by the CPT, the physician specialties that were surveyed by the AMA RUC to recommend work RVUs were the pediatricians, emergency medicine physicians, spine surgeons, and oral and maxillofacial surgeons. Our review of Medicare national claims data shows that these codes are most often utilized by anesthesiologists and interventional pain management physicians. We continue to have concerns about the utilization of these codes and will continue to review them under the Medicare program.

We will also continue contractor pricing of these codes under the

PFS. Regarding the AMA RUC-recommended work values for the moderate sedation codes, which we have not accepted, we note that RUC- recommended values for these codes were included in the CY 2006 PFS final rule with comment period (70 FR 70282). 3. Inpatient Dialysis Services (CPT Codes 90935, 90937, 90945, and 90947)

Although not discussed in the CY 2009 PFS proposed rule, we received comments requesting that CMS apply the increases in work RVUs for E&M services recommended by the AMA RUC for each CPT code with a global period of 10 and 90 days as part of the 2007 PFS proposed and final rules to the inpatient dialysis family of services.

Comment: Some commenters believed that the outpatient and inpatient dialysis services that use E&M codes as ``building blocks'' or components of their valuation should have the full increases for the

E&M codes incorporated into their values as well.

Response: Increases in E&M codes were not applied to the inpatient dialysis services because these codes do not have a global period of 10 or 90 days. The AMA RUC recommendations were specifically for codes with global periods of 10 or 90 days. We suggest that the specialty society work with the AMA RUC using the existing process to address this issue. 4. New Codes for Re-Examination at the Next 5-Year Review

As part of its annual recommendation, the AMA RUC includes a list identifying new CPT codes which will be reexamined at the next 5-Year

Review of Work RVUs. New CPT codes that have been added to this list are identified with an asterisk (*) on Table 27: AMA RUC

Recommendations and CMS' Decisions for New and Revised 2009 CPT Codes. 5. Comments Received on New CPT Codes for CY 2009

We received comments on new CPT codes for CY 2009 including

Category III codes. Since these are new codes for CY 2009, they are subject to comment as part of this final rule. Note: Category III codes are contractor priced under the PFS.

H. Establishment of Interim PE RVUs for New and Revised Physician's

Current Procedural Terminology (CPT) Codes and New Healthcare Common

Procedure Coding System (HCPCS) Codes for 2009

We have developed a process for establishing interim PE RVUs for new and revised codes that is similar to that used for work RVUs. Under this process, the AMA RUC recommends the PE direct inputs (the staff time, supplies and equipment) associated with each new code. CMS reviews the recommendations in a manner similar to our evaluation of the recommended work RVUs. The AMA RUC recommendations on the PE inputs for the new and revised CY 2009 codes were submitted to CMS as interim recommendations.

We have accepted, in the interim, the PE recommendations submitted by the RUC for the codes listed in Table 27: AMA RUC Recommendations and CMS' Decisions for New and Revised 2009 CPT Codes and Table 26 except as noted below in this section. 1. CPT Code Series 93279 Through 93292

The AMA RUC PE recommendations for cardiac monitoring services in the CPT code series 93279 through 93292 recommended that we include a

``pacemaker monitoring system'' as the necessary equipment to be used in each code of the 14 CPT code series 93279 through 93292. Because the specialty did not list a price along with the equipment item we reviewed the equipment used in the existing services that were used to crosswalk to the new codes. We found that the existing services are each assigned the pacemaker follow-up system (including software and hardware), CMS equipment code EQ198 and, as such, we have assigned this equipment item to each of the 14 new services on an interim basis.

The RUC recommended that a ``pacemaker interrogation system'' be used for the two CPT codes 93293 and 93296. However, the PE database does not contain an equipment item with this description. Because we noted a 100 percent crosswalk from existing CPT code 93733 that utilizes the pacemaker follow-up system to the new CPT code 93293, we have assigned, on an interim basis, the pacemaker follow-up system to

CPT codes 93293 and 93296 (a ``new'' service without a crosswalk).

We ask commenters to provide documentation to us as to the type and cost of equipment that is used in furnishing these services in the physician office and other information to support any suggested changes from the prior inputs. 2. CPT Code 41530

The AMA RUC recommended PE direct inputs for CPT code 41530,

Submucosal ablation of the tongue base, radiofrequency, one or more sites, per session, include a disposable pulse oximeter finger probe.

We did not accept the addition of this item to the PE database for this or any other procedure because, as we have discussed in the CY 2004 PFS proposed and final rules (68 FR 49037 and 63206), we continue to treat the pulse oximeter probe as reusable. 3. CPT Code 46930

In the AMA RUC PE recommendations for CPT code 46930, Destruction of internal hemorrhoid(s) by thermal energy (eg, infrared coagulation, cautery, radiofrequency), the specialty society requested that we add a light guide to the existing price of $3,087.50, for the infrared coagulator and provided the list price of $730 for this item. In addition, the specialty society requested that a sheath (pricing information provided by the specialty at $10.50) for the light guide be included as a typical supply for this procedure. We have reviewed the components of the existing infrared coagulator in the PE database and note its price of $3087.50 includes an infrared power unit and a hand applicator. Using our existing pricing information, we have added the price of $572 for the indicated (6mm x 220mm) light guide (the price resulting from averaging the costs of the Teflon and Sapphire tips) to the infrared coagulator for a total price of $3,659. We did not accept the AMA RUC-recommended sheath to cover the light guide that the specialty proposed to add to the PE database for this service and 4 other procedures as we do not believe it to be typically used in furnishing these services. Because the

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light guide was not a component of the infrared coagulator item at the time we re-priced our entire equipment file for CY 2005, and because this same equipment item is used for 4 other endoscopy procedures-- including CPT codes 46606, 46608, 46610, and 46612--we ask commenters to provide us with information and documentation as to whether the light guide is typical to any of these 5 procedures. Additionally, we also invite comments about the typical use of the sheath in relationship to the light guide. In the interim, while we await comments, we have assigned the new equipment price including the light guide to the new CPT code 46930 as well as the four other procedures that employ this infrared coagulator for CY 2009. 4. CPT Code 64632

For CPT code 64632, Destruction by neurolytic agent; plantar common digital nerve, the AMA RUC recommended that supply code SH062, a sclerosing solution for injection, be used as a proxy for the neurolytic agent needed to perform this procedure. We are concerned about the appropriateness of this substitution suggested by the specialty society. The society stated that it was not able to find pricing for either phenol or 4 percent ethyl alcohol, which the society believes are the commonly used analytics for this procedure. We ask commenters to provide us documentation for pricing of the phenol or 4 percent ethyl alcohol that are appropriately used in furnishing this service. In the interim, we will accept the recommendation to use the

$2.029 sclerosing solution as the proxy for the analytic agent. 5. CPT Code Series 90951 Through 90966

For the End-Stage Renal Disease (ESRD) Services including new CPT codes 90951, 90952, 90953, 90954, 90955, 90956, 90957, 90958, 90959, 90960, 90961, 90962, 90963, 90964, 90965 and 90966, the AMA RUC recommended PE direct inputs (36 minutes of clinical labor for the pre- service period and an additional 6 minutes in the post period for CPT codes 90960, 90961, 90962 and 90966) for the monthly capitation payments. For CPT codes 90967, 90968, 90969, and 90970, the ESRD codes representing per-day payments, the AMA RUC PE recommendations included 1.2 minutes of clinical labor per day. Prior to accepting these PE recommendations, we have asked the AMA RUC to review the PE inputs at an upcoming meeting to make certain that they accurately reflect the typical direct resources required for these services. In the interim, we will continue to use the established PE RVUs for these services. In addition, for CPT codes 90960 and 90961, we will ask the RUC to review the physician times for these services. 6. CPT Code 93306

The AMA RUC recommended PE direct inputs for CPT code 93306,

Echocardiography, transthoracic real-time with image documentation

(2D), including M-mode recording if performed, with spectral Doppler echocardiography, and with color flow Doppler echocardiography.

However, the AMA RUC did not recommend any changes to the PE direct inputs for the related echocardiography codes 93307, 93320 and 93325.

Prior to accepting this recommendation, we have asked the AMA RUC to review the PE inputs 93307, 93320 and 93325 to ensure that they are consistent with the recommended direct inputs for 93306. In the interim, we will continue to use the established PE RVUs for these services. 7. CPT Code 93351

The AMA RUC recommended PE inputs for CPT code 93351,

Echocardiography, transthoracic real-time with image documentation

(2D), including M-mode recording, when performed, during rest and cardiovascular stress test using treadmill, bicycle exercise and/or pharmacologically induced stress, with interpretation and report; including performance of continuous electrocardiographic monitoring with physician supervision, includes three new equipment items with pricing information proposed by the specialty society. These new equipment items include an ultrasound machine, an echocardiography exam table, and a dual image viewing and reporting system. We did not accept the recommended ultrasound machine valued at $325,000 which appears to be a newer model than that currently used in a similar procedure and priced at $248,000 in the PE database. We also did not accept the echocardiography exam table ($11,095) because we do not believe it to be the typical equipment item found in the physician's office. In place of these two new items, we assigned those PE inputs from the PE database that are typical to similar services--the $248,000 ultrasound machine and a $1,915 stretcher. We ask commenters to provide us with documentation as to the type and cost of equipment that is used in furnishing the procedure in the physician office setting along with a rationale for suggested changes from the existing inputs.

We have included the ``dual'' echocardiography image viewing and reporting system, although we accepted the base unit price of $85,000 in place of the $173,000 price provided by the specialty. This basic system is sufficient to manage, import, export, archive, and review and report digital exams; and, it contains an additional work station that is designed to function concurrently with a second ultrasound machine.

Because this unit is designed for the concurrent use of two ultrasound units (a connection for managing the images from a third unit can be added for an additional fee), we ask commenters to provide us with the typical scenario as to whether one, two, or three ultrasound units will be connected to this image management system. We also ask commenters for information as to the amount of time that this dual image management system is in use for this procedure. In the interim, we have assigned the 7 minutes from the AMA RUC PE recommendation that is indicated for the cardiac sonographer to enter the ECG and echo report elements into reporting system. 8. CPT Code 95803

CPT code 95803, Actigraphy, testing, recording, analysis, interpretation and report (minimum of 72 hours to 14 consecutive days of recording), requires the patient to wear a home monitor for 24 hours a day for 3 to 14 days. The RUC PE recommendations did not include the typical number of days the home monitor would be in use. They also did not include the necessary equipment used to analyze the data.

Therefore, we seek comment on the typical number of days for this service. We will continue to contractor price this service for 2009.

VI. Physician Self-Referral Prohibition: Annual Update to the List of

CPT/HCPCS Codes

A. General

Section 1877 of the Act prohibits a physician from referring a

Medicare beneficiary for certain designated health services (DHS) to a health care entity with which the physician (or a member of the physician's immediate family) has a financial relationship, unless an exception applies. Section 1877 of the Act also prohibits the DHS entity from submitting claims to Medicare or billing the beneficiary or any other entity for Medicare DHS that are furnished as a result of a prohibited referral.

Section 1877(h)(6) of the Act specifies that the following services are DHS:

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Clinical laboratory services.

Physical therapy services.

Occupational therapy services.

Radiology services.

Radiation therapy services and supplies.

Durable medical equipment and supplies.

Parenteral and enteral nutrients, equipment, and supplies.

Prosthetics, orthotics, and prosthetic devices and supplies.

Home health services.

Outpatient prescription drugs.

Inpatient and outpatient hospital services.

B. Speech-Language Pathology Services

As we stated in section III.I. of this final rule with comment period, section 143 of the MIPPA amended section 1877(h)(6) of the Act to specify that ``outpatient speech-language pathology services'' are

DHS, effective July 1, 2009. We note that, in the ``Phase I'' physician self-referral final rule, we defined the DHS category of ``physical therapy services'' to include speech-language pathology services because the statutory definition of ``outpatient physical therapy services'' (section 1861(p) of the Act) included speech-language pathology services (66 FR at 925). To conform the language of the regulations to MIPPA, we are revising two of the definitions at Sec. 411.351. First, we are revising the definition of ``Designated health services (DHS)'' by adding the word ``outpatient'' before the phrase

``speech-language pathology services'' in paragraph (2). Second, we are revising the definition of ``Physical therapy, occupational therapy, and speech-language pathology services'' by:

Removing the phrase ``speech-language pathology'' in the heading of the definition and wherever it occurs within the introductory paragraph and adding, in its place, the phrase

``outpatient speech-language pathology'';

Deleting the parenthetical ``(including speech-language pathology services)'' from paragraph (1) of the description of physical therapy services;

Deleting sub-paragraph (1)(iv), which describes physical therapy services as including ``Speech-language pathology services that are for the diagnosis and treatment of speech, language, and cognitive disorders that include swallowing and other oral-motor dysfunctions;'' and

Adding the following new paragraph to describe outpatient speech-language pathology services: ``(3) Outpatient speech-language pathology services, meaning those services as described in section 1861(ll)(2) of the Act that are for the diagnosis and treatment of speech, language, and cognitive disorders that include swallowing and other oral-motor dysfunctions''.

Consistent with the provisions of section 143 of the MIPPA, these changes will be effective July 1, 2009.

C. Annual Update to the Code List 1. Background

In Sec. 411.351, we specify that the entire scope of four DHS categories is defined in a list of CPT/HCPCS codes (the Code List), which is updated annually to account for changes in the most recent CPT and HCPCS publications. The DHS categories defined and updated in this manner are:

Clinical laboratory services.

Physical therapy, occupational therapy, and outpatient speech-language pathology services.

Radiology and certain other imaging services.

Radiation therapy services and supplies.

The Code List also identifies those items and services that may qualify for either of the following two exceptions to the physician self-referral prohibition:

EPO and other dialysis-related drugs furnished in or by an

ESRD facility (Sec. 411.355(g)).

Preventive screening tests, immunizations, or vaccines

(Sec. 411.355(h)).

The Code List was last updated in the CY 2008 PFS final rule with comment period (72 FR 66222) and in a subsequent correction notice (73

FR 2568). 2. Response to Comments

We received no public comments relating to the Code List that became effective January 1, 2008. 3. Revisions Effective for 2009

The updated, comprehensive Code List effective January 1, 2009 appears as Addendum J in this final rule with comment period and is available on our Web site at http://www.cms.hhs.gov/

PhysicianSelfReferral/11_List_of_Codes.asp#TopOfPage. Additions, deletions, and revisions to the Code List conform the Code List to the most recent publications of CPT and HCPCS.

Tables 29, 30, and 31 identify the additions, deletions, and revisions, respectively, to the comprehensive Code List that was published in Addendum I of the CY 2008 PFS final rule (72 FR 66574 through 66578) and revised in a subsequent correction notice (73 FR 2568).

Tables 29 and 30 also identify the additions and deletions to the lists of codes used to identify the items and services that may qualify for the exceptions in Sec. 411.355(g) (regarding EPO and other dialysis-related outpatient prescription drugs furnished in or by an

ESRD facility) and in Sec. 411.355(h) (regarding preventive screening tests, immunizations, and vaccines).

In Table 29, we specify additions that generally reflect new CPT and HCPCS codes that become effective January 1, 2009, or that became effective since our last update. Also, we are adding CPT code 0183T

(Low frequency, non-contact, non-thermal ultrasound) to the category of

Physical Therapy, Occupational Therapy, and Outpatient Speech-Language

Pathology Services. The AMA added this code to the CPT for 2008, but we inadvertently failed to add this code to our Code List.

Table 30 reflects the deletions necessary to conform the Code List to the most recent publications of CPT and HCPCS. It also reflects our decision to delete CPT codes 78000, 78001, and 78003 from the Radiology and Certain Other Imaging Services category of the Code List because we realized that these codes do not involve imaging and, therefore, should not be included in that category.

Also in the category of Radiology and Certain Other Imaging

Services and as shown in Table 31, we are making revisions to our qualifying language included in brackets for CPT codes 93320, 93321 and 93325. Our revisions reflect changes made by the AMA for the CPT 2009 that specify with which codes CPT codes 93320, 93321, and 93325 may be used. Additionally, we found that we had previously failed to include certain CPT codes with which CPT code 93325 may be used. Thus, we are revising our qualifying language in brackets for CPT 93325 to clarify that it is considered a DHS when used in conjunction with CPT codes 76825, 76826, 76827, 76828, 99903, 93304, and 93308.

We will consider comments regarding the codes listed in Tables 29, 30, and 31. Comments will be considered if we receive them by the date specified in the ``DATES'' section of this final rule with comment period. We will not consider any comment that advocates a substantive change to any of the DHS defined in Sec. 411.351.

Page 69900

Table 29--Additions to the Physician Self-Referral List of CPT \1\ HCPCS

Codes

CLINICAL LABORATORY SERVICES

0194T Procalcitonin (PCT).

PHYSICAL THERAPY, OCCUPATIONAL THERAPY, AND OUTPATIENT SPEECH-LANGUAGE

PATHOLOGY SERVICES

0183T Wound ultrasound. 95992 Canalith repositioning proc.

RADIOLOGY AND CERTAIN OTHER IMAGING SERVICES

93306 TTE w/Doppler, complete.

A9580 Sodium fluoride F-18.

RADIATION THERAPY SERVICES AND SUPPLIES

0190T Place intraoc radiation src. 0197T Intrafraction track motion. 61796 SRS, cranial lesion simple. 61797 SRS, cran les simple, addl. 61798 SRS, cranial lesion complex. 61799 SRS, cran les complex, addl. 61800 Apply SRS headframe add-on. 63620 SRS, spinal lesion. 63621 SRS, spinal lesion, addl. 77785 HDR brachytx, 1 channel. 77786 HDR brachytx, 2-12 channel. 77787 HDR brachytx over 12 chan.

DRUGS USED BY PATIENTS UNDERGOING DIALYSIS

J1750 Inj iron dextran.

PREVENTIVE SCREENING TESTS, IMMUNIZATIONS AND VACCINES

No additions

Table 30--Deletions to the Physician Self-Referral List of CPT \1\/HCPCS

Codes

CLINICAL LABORATORY SERVICES

0026T Measure remnant lipoproteins. 0041T Detect ur infect agnt w/cpas. 0043T Co expired gas analysis. 0058T Cryopreservation, ovary tiss. 0059T Cryopreservation, oocyte.

PHYSICAL THERAPY, OCCUPATIONAL THERAPY, AND OUTPATIENT SPEECH-LANGUAGE

PATHOLOGY SERVICES

0029T Magnetic tx for incontinence.

0029T Magnetic tx for incontinenceRADIOLOGY AND CERTAIN OTHER IMAGING

SERVICES

0028T Dexa body composition study. 78000 Thyroid, single uptake. 78001 Thyroid, multiple uptakes. 78003 Thyroid, suppress/stimul. 78890 Nuclear medicine data proc. 78891 Nuclear med data proc.

RADIATION THERAPY SERVICES AND SUPPLIES

61793 Focus radiation beam. 77781 High intensity brachytherapy. 77782 High intensity brachytherapy. 77783 High intensity brachytherapy. 77784 High intensity brachytherapy.

DRUGS USED BY PATIENTS UNDERGOING DIALYSIS

J1751 Iron dextran 165 injection.

J1752 Iron dextran 267 injection.

PREVENTIVE SCREENING TESTS, IMMUNIZATIONS AND VACCINES

No deletions

Table 31--Revisions to the Physician Self-Referral List of CPT \1\ HCPCS

Codes

CLINICAL LABORATORY SERVICES

No revisions

PHYSICAL THERAPY, OCCUPATIONAL THERAPY, AND OUTPATIENT SPEECH-LANGUAGE

PATHOLOGY SERVICES

No revisions

RADIOLOGY AND CERTAIN OTHER IMAGING SERVICES

93320 Doppler echo exam, heart [if used in conjunction with 93303- 93304]. 93321 Doppler echo exam, heart [if used in conjunction with 93303, 93304, 93308]. 93325 Doppler color flow add-on [if used in conjunction with 76825, 76826, 76827, 76828, 93303, 93304, 93308].

RADIATION THERAPY SERVICES AND SUPPLIES

No revisions

DRUGS USED BY PATIENTS UNDERGOING DIALYSIS

No revisions

PREVENTIVE SCREENING TESTS, IMMUNIZATIONS AND VACCINES

No revisions

VII. Physician Fee Schedule Update for CY 2009

A. Physician Fee Schedule Update

The PFS update is set under a formula specified in section 1848(d)(4) of the Act. Section 101 of the MIEA-TRHCA provided a 1-year increase in the CY 2007 conversion factor (CF) and specified that the

CF for CY 2008 must be computed as if the 1-year increase had never applied. Section 101 of the MMSEA provided a 6-month increase in the CY 2008 CF, from January 1, 2008, through June 30, 2008, and specified that the CF for the remaining portion of 2008 and the CFs for CY 2009 and subsequent years must be computed as if the 6-month increase had never applied. Section 131 of the MIPPA extended the increase in the CY 2008 CF that was applicable for the first half of the year to the entire year, provided for a 1.1 percent increase to the CY 2009 CF, and specified that the CFs for CY 2010 and subsequent years must be computed as if the increases for CYs 2007, 2008, and 2009 had never applied.

Medicare Economic Index (MEI) is equal to 1.6 percent (1.016). The update adjustment factor (UAF) is -7.0 percent (0.930). Our calculations of these figures are explained below in this section. If section 131 of the MIPPA had not been enacted, the CY 2009 CF update would have been the -15.1 percent (0.84941), which is the product of the published CY 2008 update (0.89896), the MEI (1.016), and the UAF

(0.930). Consistent with section 131 of the MIPPA, however, the update for CY 2009 is 1.1 percent.

B. The Percentage Change in the Medicare Economic Index (MEI)

The Medicare Economic Index (MEI) is authorized by section 1842(b)(3) of the Act, which states that prevailing charge levels beginning after June 30, 1973, may not exceed the level from the previous year except to the extent that the Secretary finds, on the basis of appropriate economic index data, that the higher level is justified by year-to-year economic changes.

The MEI measures the weighted-average annual price change for various inputs needed to produce physicians' services. The MEI is a fixed-weight input price index, with an adjustment for the change in economy-wide multifactor productivity. This index, which has CY 2000 base year weights,

Page 69901

is comprised of two broad categories: (1) Physician's own time; and (2) physician's PE.

The physician's own time component represents the net income portion of business receipts and primarily reflects the input of the physician's own time into the production of physicians' services in physicians' offices. This category consists of two subcomponents: (1)

Wages and salaries; and (2) fringe benefits.

The physician's PE category represents nonphysician inputs used in the production of services in physicians' offices. This category consists of wages and salaries and fringe benefits for nonphysician staff and other nonlabor inputs. The physician's PE component also includes the following categories of nonlabor inputs: Office expense; medical materials and supplies; professional liability insurance; medical equipment; prescription drugs; and other expenses. The components are adjusted to reflect productivity growth in physicians' offices by the 10-year moving average of productivity in the private nonfarm business sector.

Table 32 presents a listing of the MEI cost categories with associated weights and percent changes for price proxies for the 2009 update. For CY 2009, the increase in the MEI is 1.6 percent, which includes a 1.4 percent productivity offset based on the 10-year moving average of multifactor productivity. This is the result of a 3.6 percent increase in physician's own time and a 2.4 percent increase in physician's PE. Within the physician's PE, the largest increase occurred in prescription drugs, which increased 6.0 percent, and employee benefits, which increased 4.3 percent.

Table 32--Increase in the Medicare Economic Index Update for CY 2009 \1\

CY 2009

Cost categories and price measures

CY 2000

percent weights \2\ changes

Medicare Economic Index Total, productivity

N/A

1.6 adjusted \3\.................................

Productivity: 10-year moving average of

N/A

1.4 multifactor productivity, private nonfarm business sector \3\......................

Medicare Economic Index Total, without

100.000

3.0 productivity adjustment...................... 1. Physician's Own Time \4\...............

52.466

3.6 a. Wages and Salaries: Average Hourly

42.730

3.8

Earnings, private Nonfarm............ b. Fringe Benefits: Employment Cost

9.735

2.7

Index, benefits, private Nonfarm \4\. 2. Physician's Practice Expense \4\.......

47.534

2.4 a. Nonphysician Employee Compensation.

18.653

3.6

(1) Wages and Salaries: Employment

13.808

3.4

Cost Index, wages and salaries, weighted by occupation...........

(2) Fringe Benefits: Employment

4.845

4.3

Cost Index, fringe benefits, weighted by occupation........... b. Office Expense: Consumer Price

12.209

3.1

Index for Urban Areas (CPI-U), housing.............................. c. Drugs and Medical Materials and

4.319

4.1

Supplies.............................

(1) Medical Materials and

2.011

1.4

Supplies: Producer Price Index

(PPI), surgical appliances and supplies/CPI-U, medical equipment and supplies (equally weighted)..

(2) Pharmaceuticals: Producer

2.308

6.0

Price Index (PPI ethical prescription drugs).............. d. Professional Liability Insurance:

3.865

-2.7

Professional liability insurance

Premiums \5\......................... e. Medical Equipment: PPI, medical

2.055

0.5 instruments and equipment............ f. Other Expenses.....................

6.433

2.3

\1\ The rates of historical change are estimated for the 12-month period ending June 30, 2008, which is the period used for computing the CY 2009 update. The price proxy values are based upon the latest available Bureau of Labor Statistics data as of September 5, 2008.

\2\ The weights shown for the MEI components are the 2000 base-year weights, which may not sum to subtotals or totals because of rounding.

The MEI is a fixed-weight, Laspeyres-type input price index whose category weights indicate the distribution of expenditures among the inputs to physicians' services for CY 2000. To determine the MEI level for a given year, the price proxy level for each component is multiplied by its 2000 weight. The sum of these products (weights multiplied by the price index levels) over all cost categories yields the composite MEI level for a given year. The annual percent change in the MEI levels is an estimate of price change over time for a fixed market basket of inputs to physicians' services.

\3\ These numbers may not sum due to rounding and the multiplicative nature of their relationship.

\4\ The measures of productivity, average hourly earnings, Employment

Cost Indexes, as well as the various Producer and CPIs can be found on the BLS Web site at http://stats.bls.gov.

\5\ Derived from data collected from several major insurers (the latest available historical percent change data are for the period ending second quarter of 2008).

C. The Update Adjustment Factor (UAF)

Section 1848(d) of the Act provides that the PFS update is equal to the product of the percentage change in the MEI and the update adjustment factor (UAF). The UAF is applied to make actual and target expenditures (referred to in the statute as ``allowed expenditures'') equal. Allowed expenditures are equal to actual expenditures in a base period updated each year by the sustainable growth rate (SGR). The SGR sets the annual rate of growth in allowed expenditures and is determined by a formula specified in section 1848(f) of the Act.

The PFS update is set under a formula specified in section 1848(d)(4) of the Act. Section 101 of the MIEA-TRHCA provided a 1-year increase in the CY 2007 CF and specified that the CF for CY 2008 must be computed as if the 1-year increase had never applied. Section 101 of the MMSEA provided a 6-month increase in the CY 2008 CF, from January 1, 2008, through June 30, 2008, and specified that the CF for the remaining portion of 2008 and the CFs for CY 2009 and subsequent years must be computed as if the 6-month increase had never applied. Section 131 of the MIPPA extended the increase in the CY 2008 CF that was applicable for the first half of the year to the entire year, provided for a 1.1 percent increase to the CY 2009 CF, and specified that the

CFs for CY 2010 and subsequent years must be computed as if the increases for CYs 2007, 2008, and 2009 had never applied. 1. Calculation Under Current Law

Under section 1848(d)(4)(B) of the Act, the UAF for a year beginning with CY 2001 is equal to the sum of the following--

Prior Year Adjustment Component. An amount determined by--

+ Computing the difference (which may be positive or negative) between

Page 69902

the amount of the allowed expenditures for physicians' services for the prior year (the year prior to the year for which the update is being determined) and the amount of the actual expenditures for those services for that year;

+ Dividing that difference by the amount of the actual expenditures for those services for that year; and

+ Multiplying that quotient by 0.75.

Cumulative Adjustment Component. An amount determined by--

+ Computing the difference (which may be positive or negative) between the amount of the allowed expenditures for physicians' services from April 1, 1996, through the end of the prior year and the amount of the actual expenditures for those services during that period;

+ Dividing that difference by actual expenditures for those services for the prior year as increased by the SGR for the year for which the UAF is to be determined; and

+ Multiplying that quotient by 0.33.

Section 1848(d)(4)(E) of the Act requires the Secretary to recalculate allowed expenditures consistent with section 1848(f)(3) of the Act. Section 1848(f)(3) specifies that the SGR (and, in turn, allowed expenditures) for the upcoming CY (CY 2009 in this case), the current CY (that is, CY 2008) and the preceding CY (that is, CY 2007) are to be determined on the basis of the best data available as of

September 1 of the current year. Allowed expenditures for a year are initially estimated and subsequently revised twice. The second revision occurs after the CY has ended (that is, we are making the final revision to 2007 allowed expenditures in this final rule with comment).

Once the SGR and allowed expenditures for a year have been revised twice, they are final.

Table 33 shows annual and cumulative allowed and actual expenditures for physicians' services from April 1, 1996, through the end of the current CY, including the short periods in 1999 when we transitioned to a CY system. Also shown is the SGR corresponding with each period. The calculation of the SGR is discussed in detail below in this section.

Table 33--Annual and Cumulative Allowed and Actual Expenditures for Physicians' Services from April 1, 1996 Through the End of the Current Calendar Year

Annual

Cumulative

Cumulative allowed

Annual actual

allowed

actual

Period

expenditures expenditures expenditures expenditures

FY/CY SGR

($ in

($ in billions)

billions)

4/1/96-3/31/97...............................

\1\ $48.9

$48.9

$48.9 N/A. 4/1/97-3/31/98...............................

50.5

49.5

99.4

98.4 FY 1998 = 3.2%. 4/1/98-3/31/99...............................

52.6

50.8

152.0

149.2 FY 1999 = 4.2%. 1/1/99-3/31/99...............................

13.3

13.2

(\2\)

149.2 FY 1999 = 4.2%. 4/1/99-12/31/99..............................

42.1

39.7

(\3\)

188.9 FY 2000 = 6.9%. 1/1/99-12/31/99..............................

55.3

52.9

194.0

188.9 FY 1999/2000. 1/1/00-12/31/00..............................

59.3

58.4

253.4

247.3 CY 2000 = 7.3%. 1/1/01-12/31/01..............................

62.0

66.7

315.4

314.1 CY 2001 = 4.5%. 1/1/02-12/31/02..............................

67.2

71.5

382.6

385.6 CY 2002 = 8.3%. 1/1/03-12/31/03..............................

72.1

78.8

454.6

464.4 CY 2003 = 7.3%. 1/1/04-12/31/04..............................

76.8

87.7

531.5

552.1 CY 2004 = 6.6%. 1/1/05-12/31/05..............................

80.1

92.4

611.5

644.5 CY 2005 = 4.2%. 1/1/06-12/31/06..............................

81.3

94.1

692.8

738.6 CY 2006 = 1.5%. 1/1/07-12/31/07..............................

84.1

93.9

776.9

832.4 CY 2007 = 3.5%. 1/1/08-12/31/08..............................

86.8

94.4

863.7

926.8 CY 2008 = 3.2%. 1/1/09-12/31/09..............................

93.2

956.9

NA CY 2009 = 7.4%.

\1\ Allowed expenditures in the first year (April 1, 1996-March 31, 1997) are equal to actual expenditures. All subsequent figures are equal to quarterly allowed expenditure figures increased by the applicable SGR. Cumulative allowed expenditures are equal to the sum of annual allowed expenditures. We provide more detailed quarterly allowed and actual expenditure data on our Web site at the following address: http://www.cms.hhs.gov/

SustainableGRatesConFact/. We expect to update the Web site with the most current information later this month.

\2\ Allowed expenditures for the first quarter of 1999 are based on the FY 1999 SGR.

\3\ Allowed expenditures for the last three quarters of 1999 are based on the FY 2000 SGR.

Consistent with section 1848(d)(4)(E) of the Act, Table 33 includes our final revision of allowed expenditures for CY 2007, a recalculation of allowed expenditures for CY 2008, and our initial estimate of allowed expenditures for CY 2009. To determine the UAF for CY 2009, the statute requires that we use allowed and actual expenditures from April 1, 1996 through December 31, 2008 and the CY 2009 SGR. Consistent with section 1848(d)(4)(E) of the Act, we will be making revisions to the CY 2008 and CY 2009 SGRs and CY 2008 and CY 2009 allowed expenditures.

Because we have incomplete actual expenditure data for CY 2008, we are using an estimate for this period. Any difference between current estimates and final figures will be taken into account in determining the UAF for future years.

We note that Table 33 contains updated actual expenditures for each time period from April 1, 1997 through December 31, 2008. We discovered that fifteen procedure codes were inadvertently omitted from the measurement of actual expenditures beginning in 1998. An additional 6 codes were omitted from the measurement of actual expenditures in 2005 and 2006 only, but have been included in actual expenditures since 2007. Therefore, the measurement of actual expenditures for FY 1998 and each subsequent time period was lower than it should have been. We will be making no changes to PFS payments made for services furnished prior to CY 2009. However, under section 1848(d) of the Act, we must include these codes in the measurement of actual expenditures for historical, current, and future periods. The inclusion of these additional actual expenditures will have no effect on the 2009 update. Also, we estimate that the inclusion of the additional expenditures for these codes will not increase the number of years that we expect the maximum reduction in the physician fee schedule update to apply under current law. This correction is consistent with the actions taken in 2001 when we discovered that another set of codes inadvertently had not been included in the measurement

Page 69903

of actual expenditures (66 FR 55314). As discussed in detail below, consistent with section 1848(f)(3) of the Act, in this final rule with comment, we are making our preliminary estimate of the CY 2009 SGR, a revision to the CY 2008 SGR, and our final revision to the CY 2007 SGR.

All of the inadvertently excluded codes were taken into consideration for purposes of estimating the SGRs for these 3 years.

We are using figures from Table 33 in the following statutory formula:

GRAPHIC

TIFF OMITTED TR19NO08.294

UAF09= Update Adjustment Factor for CY 2009 = -26.6 percent

Target08= Allowed Expenditures for CY 2008 = $86.8 billion

Actual08= Estimated Actual Expenditures for CY 2008 =

$94.4 billion

Target 4/96-12/08= Allowed Expenditures from 4/1/1996- 12/31/2008 = $863.7 billion

Actual 4/96-12/08= Estimated Actual Expenditures from 4/ 1/1996-12/31/2008 = $926.8 billion

SGR09= 7.4 percent (1.074)

GRAPHIC

TIFF OMITTED TR19NO08.295

Section 1848(d)(4)(D) of the Act indicates that the UAF determined under section 1848(d)(4)(B) of the Act for a year may not be less than

-0.07 or greater than 0.03. Since -0.266 is less than -0.07, the UAF for CY 2009 will be -0.07.

Section 1848(d)(4)(A)(ii) of the Act indicates that 1.0 should be added to the UAF determined under section 1848(d)(4)(B) of the Act.

Thus, adding 1.0 to -0.07 makes the UAF equal to 0.93.

VIII. Allowed Expenditures for Physicians' Services and the Sustainable

Growth Rate (SGR)

A. Medicare Sustainable Growth Rate

The SGR is an annual growth rate that applies to physicians' services paid by Medicare. The use of the SGR is intended to control growth in aggregate Medicare expenditures for physicians' services.

Payments for services are not withheld if the percentage increase in actual expenditures exceeds the SGR. Rather, the PFS update, as specified in section 1848(d)(4) of the Act, is adjusted based on a comparison of allowed expenditures (determined using the SGR) and actual expenditures. If actual expenditures exceed allowed expenditures, the update is reduced. If actual expenditures are less than allowed expenditures, the update is increased.

Section 1848(f)(2) of the Act specifies that the SGR for a year

(beginning with CY 2001) is equal to the product of the following four factors:

(1) The estimated change in fees for physicians' services;

(2) The estimated change in the average number of Medicare fee-for- service beneficiaries;

(3) The estimated projected growth in real GDP per capita; and

(4) The estimated change in expenditures due to changes in statute or regulations.

In general, section 1848(f)(3) of the Act requires us to publish

SGRs for 3 different time periods, no later than November 1 of each year, using the best data available as of September 1 of each year.

Under section 1848(f)(3)(C)(i) of the Act, the SGR is estimated and subsequently revised twice (beginning with the FY and CY 2000 SGRs) based on later data. (The Act also provides for adjustments to be made to the SGRs for FY 1998 and FY 1999. See the February 28, 2003 Federal

Register (68 FR 9567) for a discussion of these SGRs). Under section 1848(f)(3)(C)(ii) of the Act, there are no further revisions to the SGR once it has been estimated and subsequently revised in each of the 2 years following the preliminary estimate. In this final rule with comment, we are making our preliminary estimate of the CY 2009 SGR, a revision to the CY 2008 SGR, and our final revision to the CY 2007 SGR.

B. Physicians' Services

Section 1848(f)(4)(A) of the Act defines the scope of physicians' services covered by the SGR. The statute indicates that ``the term physicians' services includes other items and services (such as clinical diagnostic laboratory tests and radiology services), specified by the Secretary, that are commonly performed or furnished by a physician or in a physician's office, but does not include services furnished to a Medicare+Choice plan enrollee.'' We published a definition of physicians' services for use in the SGR in the November 1, 2001 Federal Register (66 FR 55316). We defined physicians' services to include many of the medical and other health services listed in section 1861(s) of the Act. For purposes of determining allowed expenditures, actual expenditures, and SGRs, we have specified that physicians' services include the following medical and other health services if bills for the items and services are processed and paid by

Medicare carriers (and those paid through intermediaries where specified) or the equivalent services processed by the Medicare

Administrative Contractors:

Physicians' services.

Services and supplies furnished incident to physicians' services.

Outpatient physical therapy services and outpatient occupational therapy services.

Antigens prepared by, or under the direct supervision of, a physician.

Services of PAs, certified registered nurse anesthetists, certified nurse midwives, clinical psychologists, clinical social workers, NPs, and certified nurse specialists.

Screening tests for prostate cancer, colorectal cancer, and glaucoma.

Screening mammography, screening pap smears, and screening pelvic exams.

Diabetes outpatient self-management training (DSMT) services.

MNT services.

Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests (including outpatient diagnostic laboratory tests paid through intermediaries).

X-ray, radium, and radioactive isotope therapy.

Surgical dressings, splints, casts, and other devices used for the reduction of fractures and dislocations.

Bone mass measurements.

An initial preventive physical exam.

Page 69904

Cardiovascular screening blood tests.

Diabetes screening tests.

Telehealth services.

Physician work and resources to establish and document the need for a power mobility device.

Comment: We received over 40 comments from organizations representing physicians, practitioners, and beneficiaries concerning the SGR and the physician update. Many commenters expressed relief that, as a result of the MIPPA, the 0.5 percent update in effect for the first half of 2008 was extended to the entire year, and the mid- year 2008 rate reduction of -10.6 percent was retroactively replaced with the rates in effect from January through June 2008. They were further relieved that in lieu of the estimated -15 percent update that would otherwise have applied for 2009, the MIPPA specified a 1.1 percent update for CY 2009. However, these commenters remain concerned about the estimated negative update for CY 2010 of approximately -21 percent, followed by multiple years of negative physician updates of approximately -5 percent. Commenters described how they believe the SGR and update formulas are flawed, and they urged us to work with the

Congress to develop a new methodology. Some commenters suggested using our administrative authority to lessen the negative impact by removing drugs from the SGR, accounting for NCDs in the allowed expenditures targets, and reducing the productivity adjustment to the MEI.

Response: Ultimately, the formula for the SGR and the physician update are dictated by statute. We are required to follow this methodology when calculating the payment rates under the PFS. We look forward to working with the Congress, the physician community, and other interested parties as we continue to analyze appropriate alternatives to the current system that could ensure appropriate payments while promoting high quality care, without increasing Medicare costs.

Comment: Many commenters emphasized that we must implement the 1.1 percent update using the current 2008 CF as the base rate. Some requested that we include explanations of the calculations used to implement the 1.1 percent conversion factor update and how we changed the application of 5-Year Review BN. Many commenters requested that we provide examples showing how these changes affect different categories of services.

Response: Per the MIPPA, the 1.1 percent physician update is applied to the CY 2008 CF. Later in this section, we explain the calculations used for the CY 2009 CF, including how we implemented both the 1.1 percent update and the change in the application of 5-Year

Review BN.

For the impact of these changes by specialty, see the Regulatory

Impact Analysis in section XVI. of this final rule with comment period.

In that section, we also include the overall impact of this final rule with comment period on selected procedures.

C. Preliminary Estimate of the SGR for 2009

Our preliminary estimate of the CY 2009 SGR is 7.4 percent. We first estimated the CY 2009 SGR in March 2008, and we made the estimate available to the MedPAC and on our Web site. Table 34 shows the March 2008 estimate and our current estimates of the factors included in the

CY 2009 SGR.

Table 34--2009 SGR Calculation

Statutory factors

March estimate

Current estimate

Fees............................ 2.1 percent

2.1 percent

(1.021).

Enrollment...................... -0.2 percent

-0.2 percent

(0.998).

Real Per Capita GDP............. 1.8 percent

1.2 percent

(1.018).

(1.012).

Law and Regulation.............. -2.9 percent

4.2 percent

(0.971).

(1.042).

Total....................... 0.7 percent

7.4 percent

(1.007).

(1.074).

Note: Consistent with section 1848(f)(2) of the Act, the statutory factors are multiplied, not added, to produce the total

(that is, 1.021 x 0.998 x 1.012 x 1.042 = 1.074). A more detailed explanation of each figure is provided in section VIII.F.1 of this preamble.

D. Revised Sustainable Growth Rate for 2008

Our current estimate of the CY 2008 SGR is 3.2 percent. Table 35 shows our preliminary estimate of the CY 2008 SGR that was published in the CY 2008 PFS final rule with comment period (72 FR 66379) and our current estimate.

Table 35--2008 SGR Calculation

Estimate from CY

Statutory factors

2008 final rule

Current estimate

Fees............................ 1.9 percent

1.4 percent

(1.019).

(1.014).

Enrollment...................... -0.7 percent

-3.2 percent

(0.993).

(0.968).

Real Per Capita GDP............. 1.7 percent

1.6 percent

(1.017).

(1.016).

Law and Regulation.............. -2.9 percent

3.5 percent

(0.971).

(1.035).

Total....................... -0.1 percent

3.2 percent

(0.999).

(1.032).

A more detailed explanation of each figure is provided in section

VIII.F.2 of this preamble.

E. Final Sustainable Growth Rate for 2007

The SGR for 2007 is 3.5 percent. Table 36 shows our preliminary estimate of the 2007 SGR from the CY 2007 PFS final rule with comment period (71 FR 69757), our revised estimate from the CY 2008 PFS final rule with comment period (72 FR 66380) and the final figures determined using the best available data as of September 1, 2008.

Page 69905

Table 36--2007 SGR Calculation

Estimate from CY 2006

Estimate from CY 2007

Statutory factors

final rule

Final

Fees................................. 2.2 percent (1.022).... 1.9 percent (1.019).... 2.0 percent (1.020).

Enrollment........................... -0.9 percent (0.991)... -2.6 percent (0.974)... -2.0 percent (0.980).

Real per Capita GDP.................. 2.0 percent (1.020).... 1.9 percent (1.019).... 1.8 percent (1.018).

Law and Regulation................... -1.5 percent (0.985)... 2.0 percent (1.020).... 1.7 percent (1.017).

Total............................ 1.8 percent (1.018).... 3.2 percent (1.032).... 3.5 percent (1.035).

A more detailed explanation of each figure is provided in section

VIII.F.3. of this final rule.

E. Calculation of 2009, 2008, and 2007 Sustainable Growth Rates 1. Detail on the CY 2009 SGR

All of the figures used to determine the CY 2009 SGR are estimates that will be revised based on subsequent data. Any differences between these estimates and the actual measurement of these figures will be included in future revisions of the SGR and allowed expenditures and incorporated into subsequent PFS updates.

Factor 1--Changes in Fees for Physicians' Services (Before

Applying Legislative Adjustments) for CY 2009

This factor is calculated as a weighted-average of the CY 2009 changes in fees for the different types of services included in the definition of physicians' services for the SGR. Medical and other health services paid using the PFS are estimated to account for approximately 81.7 percent of total allowed charges included in the SGR in CY 2009 and are updated using the MEI. The MEI for CY 2009 is 1.6 percent. Diagnostic laboratory tests are estimated to represent approximately 7.7 percent of Medicare allowed charges included in the

SGR for CY 2009. Medicare payments for these tests are updated by the

Consumer Price Index for Urban Areas (CPI-U), which is 5.0 percent for

CY 2009. However, section 145 of the MIPPA reduces the increase applied to clinical laboratory tests by 0.5 percent for CY 2009 through CY 2013. Therefore, for CY 2009, diagnostic laboratory tests will receive an update of 4.5 percent. Drugs are estimated to represent 10.6 percent of Medicare allowed charges included in the SGR in CY 2009. We estimated a weighted-average change in fees for drugs included in the

SGR (using the ASP+6 percent pricing methodology) of 3.9 percent for CY 2009.

Table 37 shows the weighted-average of the MEI, laboratory, and drug price changes for CY 2009.

Table 37--Weighted-Average of the MEI, Laboratory, and Drug Price

Changes for CY 2009

Weight

Update

Physician...............................

0.817

1.6

Laboratory..............................

0.077

4.5

Drugs...................................

0.106

3.9

Weighted-average........................

1.000

2.1

We estimate that the weighted-average increase in fees for physicians' services in CY 2009 under the SGR (before applying any legislative adjustments) will be 2.1 percent.

Factor 2--The Percentage Change in the Average Number of Part

B Enrollees From CY 2008 to CY 2009

This factor is our estimate of the percent change in the average number of fee-for-service enrollees from CY 2008 to CY 2009. Services provided to Medicare Advantage (MA) plan enrollees are outside the scope of the SGR and are excluded from this estimate. We estimate that the average number of Medicare Part B fee-for-service enrollees will decrease by 0.2 percent from CY 2008 to CY 2009. Table 38 illustrates how this figure was determined.

Table 38--Average Number of Medicare Part B Fee-for-Service Enrollees

From CY 2008 to CY 2009

Excluding beneficiaries enrolled in MA plans

2008

2009

Overall......................... 41.662 million.... 42.425 million.

Medicare Advantage (MA)......... 9.592 million..... 10.431 million.

Net............................. 32.070 million.... 31.995 million.

Percent Increase................ .................. -0.2 percent.

An important factor affecting fee-for-service enrollment is beneficiary enrollment in Medicare Advantage (MA) plans. Because it is difficult to estimate the size of the MA enrollee population before the start of a CY, at this time we do not know how actual enrollment in MA plans will compare to current estimates. For this reason, the estimate may change substantially as actual Medicare fee-for-service enrollment for CY 2009 becomes known.

Factor 3--Estimated Real Gross Domestic Product per Capita

Growth in 2009

We estimate that the growth in real GDP per capita from CY 2008 to

CY 2009 will be 1.2 percent (based on the

Page 69906

10-year average GDP over the 10 years of 2000 through 2009). Our past experience indicates that there have also been changes in estimates of real per capita GDP growth made before the year begins and the actual change in GDP computed after the year is complete. Thus, it is possible that this figure will change as actual information on economic performance becomes available to us in 2009.

Factor 4--Percentage Change in Expenditures for Physicians'

Services Resulting From Changes in Statute or Regulations in CY 2009

Compared With CY 2008

The statutory and regulatory provisions that will affect expenditures in CY 2009 relative to CY 2008 are estimated to have an impact on expenditures of 4.2 percent. These include the DRA provision reducing payments for imaging services, the MMSEA provision regarding the PQRI bonuses payable in 2009, and the MIPPA provisions regarding the change in cost sharing for mental health services, the physician update, and the change in application of BN to the CF. The details of the MIPPA provisions are discussed in section III. of this final rule with comment period. 2. Detail on the 2008 SGR

A more detailed discussion of our revised estimates of the four elements of the 2008 SGR follows.

Factor 1--Changes in Fees for Physicians' Services (Before

Applying Legislative Adjustments) for 2008

This factor was calculated as a weighted-average of the 2008 changes in fees that apply for the different types of services included in the definition of physicians' services for the SGR.

We estimate that services paid using the PFS account for approximately 81.9 percent of total allowed charges included in the SGR in CY 2008. These services were updated using the CY 2008 MEI of 1.8 percent. We estimate that diagnostic laboratory tests represent approximately 7.7 percent of total allowed charges included in the SGR in CY 2008. Medicare payments for these tests are updated by the CPI-U.

However, section 628 of the MMA specifies that diagnostic laboratory tests will receive an update of 0.0 percent from CY 2004 through CY 2008. We estimate that drugs represent 10.4 percent of Medicare-allowed charges included in the SGR in CY 2008. We estimate a weighted-average change in fees for drugs included in the SGR of -0.5 percent for CY 2008.

Table 39 shows the weighted-average of the MEI, laboratory, and drug price changes for CY 2008.

Table 39--Weighted-Average of the MEI, Laboratory, and Drug Price

Changes for CY 2008

Weight

Update

Physician...............................

0.819

1.8

Laboratory..............................

0.077

0.0

Drugs...................................

0.104

-0.5

Weighted-average........................

1.000

1.4

After considering the elements described in Table 39, we estimate that the weighted-average increase in fees for physicians' services in 2008 under the SGR (before applying any legislative adjustments) will be 1.4 percent. Our estimate of this factor in the CY 2008 PFS final rule with comment period was 1.9 percent (72 FR 66380). The decrease in the estimate is due to the availability of some actual data.

Factor 2--The Percentage Change in the Average Number of Part

B Enrollees From CY 2007 to CY 2008

We estimate that the average number of Medicare Part B fee-for- service enrollees (excluding beneficiaries enrolled in Medicare

Advantage plans) decreased by 3.2 percent in CY 2008. Table 40 illustrates how we determined this figure.

Table 40--Average Number of Medicare Part B Fee-for-Service Enrollees

From CY 2007 to CY 2008

Excluding beneficiaries enrolled in MA plans

2007

2008

Overall......................... 41.055 million.... 41.662 million.

Medicare Advantage (MA)......... 7.926 million..... 9.592 million.

Net............................. 33.129 million.... 32.070 million.

Percent Increase................ .................. -3.2 percent.

Our estimate of the -3.2 percent change in the number of fee-for- service enrollees, net of Medicare Advantage enrollment for CY 2008 compared to CY 2007, is lower than our original estimate of -0.7 percent in the CY 2008 PFS final rule with comment period (72 FR 66381). While our current projection based on data from 8 months of 2008 is lower than our original estimate of -0.7 percent when we had no actual data, it is still possible that our final estimate of this figure will be different once we have complete information on CY 2008 fee-for-service enrollment.

Factor 3--Estimated Real Gross Domestic Product per Capita

Growth in CY 2008

We estimate that the growth in real GDP per capita will be 1.6 percent for CY 2008 (based on the 10-year average GDP over the 10 years of CY 1999 through CY 2008). Our past experience indicates that there have also been differences between our estimates of real per capita GDP growth made prior to the year's end and the actual change in this factor. Thus, it is possible that this figure will change further as complete actual information on CY 2008 economic performance becomes available to us in 2009.

Page 69907

Factor 4--Percentage Change in Expenditures for Physicians'

Services Resulting From Changes in Statute or Regulations in CY 2008

Compared With CY 2007

The statutory and regulatory provisions that will affect expenditures in CY 2008 relative to CY 2007 are estimated to have an impact on expenditures of 3.5 percent. These include the DRA provision reducing payments for imaging services, the MIEA-TRHCA provisions regarding the 2007 PQRI reporting bonuses payable in 2008, and the

MIPPA provisions regarding the physician update and the bonus payments for mental health services. The details of the MIPPA provisions are discussed in section III of this final rule with comment period. 3. Detail on the CY 2007 SGR

A more detailed discussion of our final revised estimates of the four elements of the CY 2007 SGR follows.

Factor 1--Changes in Fees for Physicians' Services (Before

Applying Legislative Adjustments) for 2007

This factor was calculated as a weighted-average of the CY 2007 changes in fees that apply for the different types of services included in the definition of physicians' services for the SGR.

Services paid using the PFS accounted for approximately 82.8 percent of total Medicare-allowed charges included in the SGR for CY 2007 and are updated using the MEI. The MEI for CY 2007 was 2.1 percent. Diagnostic laboratory tests represented approximately 7.4 percent of total CY 2007 Medicare allowed charges included in the SGR and are updated by the CPI-U. However, section 628 of the MMA specifies that diagnostic laboratory tests will receive an update of 0.0 percent from CY 2004 through CY 2008. Drugs represented approximately 9.7 percent of total Medicare-allowed charges included in the SGR for CY 2007. We estimate a weighted-average change in fees for drugs included in the SGR of 2.1 percent for 2007. Table 41 shows the weighted-average of the MEI, laboratory, and drug price changes for CY 2007.

Table 41--Weighted-Average of the MEI, Laboratory, and Drug Price

Changes for CY 2007

Weight

Update

Physician...............................

0.828

2.1

Laboratory..............................

0.074

0.0

Drugs...................................

0.097

2.1

Weighted-average........................

1.000

2.0

After considering the elements described in Table 41, we estimate that the weighted-average increase in fees for physicians' services in

CY 2007 under the SGR (before applying any legislative adjustments) was 2.0 percent. This figure is a final one based on complete data for CY 2007.

Factor 2--The Percentage Change in the Average Number of Part

B Enrollees From CY 2006 to CY 2007

We estimate the decrease in the number of fee-for-service enrollees

(excluding beneficiaries enrolled in MA plans) from CY 2006 to CY 2007 was -2.0 percent. Our calculation of this factor is based on complete data from CY 2007. Table 42 illustrates the calculation of this factor.

Table 42--Average Number of Medicare Part B From CY 2006 to CY 2007

Excluding beneficiaries enrolled in MA Plans

2006

2007

Overall......................... 40.360 million.... 41.055 million.

Medicare Advantage (MA)......... 6.550 million..... 7.926 million.

Net............................. 33.811 million.... 33.129 million.

Percent Increase................ .................. -2.0 percent.

Factor 3--Estimated Real Gross Domestic Product per Capita

Growth in 2007

We estimate that the growth in real per capita GDP was 1.8 percent in 2007 (based on the 10-year average GDP over the 10 years of CY 1998 through CY 2007). This figure is a final one based on complete data for

CY 2007.

Factor 4--Percentage Change in Expenditures for Physicians'

Services Resulting From Changes in Statute or Regulations in CY 2007

Compared With CY 2006

Our final estimate for the net impact on expenditures from the statutory and regulatory provisions that affect expenditures in CY 2007 relative to CY 2006 is 1.7 percent. These include the DRA provision reducing payments for imaging services and the MIEA-TRHCA 1-year adjustment to the CF.

IX. Anesthesia and Physician Fee Schedule Conversion Factors for CY 2009

The CY 2009 PFS CF is $36.0666. The CY 2009 national average anesthesia CF is $20.9150.

A. Physician Fee Schedule Conversion Factor

The PFS CF for a year is calculated in accordance with section 1848(d)(1)(A) of the Act by multiplying the previous year's CF by the

PFS update. The formula for calculating the PFS update is set forth in section 1848(d)(4)(A) of the Act. In general, the PFS update is determined by multiplying the CF for the previous year by the percentage increase in the MEI times the update adjustment factor

(UAF), which is calculated as specified under section 1848(d)(4)(B) of the Act. However, section 101 of the MIEA-TRHCA provided a 1-year increase in the CY 2007 CF and specified that the CF for CY 2008 must be computed as if the 1-year increase had never applied. Section 101 of the MMSEA provided a 6-month increase in the CY 2008 CF, from January 1, 2008, through June 30, 2008,

Page 69908

and specified that the CF for the remaining portion of 2008 and the CFs for CY 2009 and subsequent years must be computed as if the 6-month increase had never applied. Section 131 of the MIPPA extended the MMSEA increase in the CY 2008 CF that was applicable to the first half of the year to the entire year, provided a 1.1 percent increase to the CY 2009

CF, and specified that the CFs for CY 2010 and subsequent years must be computed as if the increases for CYs 2007, 2008, and 2009 had never applied.

If section 101 of the MMSEA had not been enacted, the CY 2008 CF update would have been -10.1 percent (0.89896), as published in the CY 2008 PFS final rule with comment period (72 FR 66383). For CY 2009, the percentage increase in the MEI is equal to 1.6 percent (1.016). The UAF is -7.0 percent (0.930). If section 131 of the MIPPA had not been enacted, the CY 2009 CF update would have been -15.1 percent, which is the product of the published CY 2008 update (0.89896), the percentage increase in the MEI (1.016), and the UAF (0.930).

Section 131 of the MIPPA provided a 1.1 percent increase in the CY 2009 CF. Consistent with section 131 of the MIPPA, the update for CY 2009 is 1.1 percent.

Budget Neutrality Adjustment: Section 133(b) of the MIPPA

Section 1848(c)(2)(B)(i) of the Act requires that we review the

RVUs no less often than every 5 years. Section 1848(c)(2)(B)(ii)(II) of the Act requires that increases or decreases in RVUs for a year may not cause the amount of expenditures for the year to differ by more than

$20 million from what expenditures would have been in the absence of these changes. If this threshold is exceeded, we must make adjustments to preserve BN.

The most recent 5-Year Review of the work RVUs was implemented in 2007 and 2008. We estimated that the 5-Year Review of work RVUs, including the refinement to the work RVU changes for the additional codes and the increases in the work of anesthesia services, would result in a change in expenditures that would exceed $20 million if we made no offsetting adjustment. In CY 2007, we met the BN requirement by applying a separate BN adjustment factor to the work RVUs of -10.06 percent. In CY 2008, due to subsequent changes related to the 5-Year

Review of work, the separate BNF for work RVUs was -11.94 percent.

Section 133(b) of the MIPPA requires the Secretary, instead of continuing to apply the BN adjustment required as a result of the 5-

Year Review of work to the work RVUs, to apply the required BN adjustment to the CF beginning with CY 2009. Shifting the 11.94 percent separate work adjustment to the CF requires a reduction to the CF of 6.41 percent (0.9359). (Work RVUs represent slightly over half of PFS payments; PE and malpractice RVUs comprise the rest.) Payments for the work portion of the PFS will increase as a result of this change.

However, this increase will be offset in the aggregate by the decrease to the CF. Therefore, this increase is budget neutral prior to the interaction with section 5102 of the DRA (see below for a discussion of the interaction with section 5102 of the DRA.) For the impact by specialty of section 133(b) of the MIPPA, see the Regulatory Impact

Analysis in section XVI. of this final rule with comment period.

Section 5102(b)(1) of the DRA amended section 1848(b) of the Act and added paragraph (4), requiring that the payment for the TC of certain imaging services (including the technical portion of the global fee) cannot exceed the payment for the same service under the

Outpatient Prospective Payment System (OPPS). In general, if the payment for these services as calculated using PFS RVUs would exceed the payment for the same service under the OPPS, we cap the TC of the

PFS payment amount at the OPPS payment amount. Section 5102(a)(3) amended section 1848(c)(2)(B) of the Act and added clause (v) to exempt certain reduced expenditures from the BN provision. Section 5102(b)(2) added subclause (II), which specifically excluded savings generated by the OPPS imaging services cap from the PFS BN requirement. (For further discussion of section 5102 of the DRA, see the CY 2007 PFS final rule with comment period (71 FR 69659).)

The separate work BN adjustor did not impact payment for the TC of imaging services, since this portion of the service does not have work

RVUs. When the BN adjustment is made to the CF as required under section 133(b) of MIPPA, however, the adjustment does lower payments for the TC of imaging services. Because the reduction to the CF lowers the payments for the TC of imaging services, there are less aggregate savings resulting from the OPPS payment cap under section 5102 of the

DRA with the BN adjustment to the CF than there are with the separate work BN adjustment. This is because services will be paid at the OPPS rate both before and after the application of the BN adjustment, resulting in no BN savings from these services. We estimate that the reduction in aggregate savings will be approximately $0.2 billion in 2009. In other words, Medicare expenditures in the aggregate will increase by $0.2 billion relative to what would have occurred in the absence of section 133(b) of the MIPPA.

As stated earlier, section 1848(c)(2)(B)(ii)(II) of the Act requires that increases or decreases in RVUs may not cause the amount of expenditures for the year to differ by more than $20 million from what expenditures would have been in the absence of these changes. If this threshold is exceeded, we must make adjustments to preserve BN. We estimate that CY 2009 RVU changes would result in a decrease in

Medicare physician expenditures. Therefore, we are increasing the CF by 1.0008 to offset this estimated decrease in Medicare physician expenditures due to the CY 2009 RVU changes.

We illustrate the calculation of the CY 2009 PFS CF in Table 43.

Table 43--Calculation of the CY 2009 PFS CF

CY 2008 Conversion Factor....................... $38.0870.

CY 2009 CF Update............................... 1.1 percent (1.011).

CY 2009 CF Budget Neutrality Adjustment......... 0.08 percent (1.0008). 5-Year Review Budget Neutrality Adjustment...... -6.41 percent

(0.9359).

CY 2009 Conversion Factor....................... $36.0666.

Payment for services under the PFS will be calculated as follows:

Payment = [(RVU work x GPCI work) + (RVU PE x GPCI PE) + (RVU malpractice x GPCI malpractice)] x CF.

B. Anesthesia Conversion Factor

We calculate the anesthesia CF in Table 44. Anesthesia services do not have RVUs like other PFS services. Therefore, we account for any necessary RVU adjustments through an adjustment to the anesthesia CF to simulate changes to RVUs. More specifically, if there is an

Page 69909

adjustment to the work, PE, or malpractice RVUs, these adjustments are applied to the respective shares of the anesthesia CF as these shares are proxies for the work, PE, and malpractice RVUs for anesthesia services.

As explained above, section 133(b) of the MIPPA provided for the application of the 2007-2008 5-Year work review BN adjustor to the PFS

CF for years beginning with CY 2009. To make this change for the anesthesia CF, we recalculated the adjustments to the anesthesia CF for

CY 2007 and CY 2008 by removing the BN adjustor for work, which had been applied to calculate the CF for each of these years. The adjustor for the work BN is applied as a separate adjustment to the anesthesia

CF as it is similarly applied to the PFS CF. In addition, for the calculation of the CY 2008 anesthesia CF, we recognized the 32 percent increase in anesthesia work adopted under the third 5-Year Review of work. We also applied the adjustments that were made in CY 2007 and CY 2008 for anesthesia PE and anesthesia malpractice. (The anesthesia CFs shown in the Table 44 for 2007 and 2008 are not the rates used to pay claims for services furnished in those calendar years, but are recalculated anesthesia CFs showing the removal of the work BN adjustor.)

Table 44--Calculation of the CY 2009 Anesthesia Conversion Factor

CY 2006 Anesthesia CF...................................

$17.7663 2007 Adjustment without BN adjustor.....................

0.9874

CY 2007 Anesthesia CF...................................

$17.5424 2007 Adjustment without BN adjustor.....................

1.2528 2008 Legislative Update Factor.......................... 0.5% (1.0050)

CY 2008 Anesthesia CF...................................

$22.0871 2009 MIPPA CF Adjustor..................................

0.9359 2009 MIPAA Update (1.1%)................................

1.0110 2009 Combined Adjustment to Anesthesia CF...............

1.0008

CY 2009 Anesthesia CF...................................

$20.9150

X. Telehealth Originating Site Facility Fee Payment Amount Update

Section 1834(m) of the Act establishes the payment amount for the

Medicare telehealth originating site facility fee for telehealth services provided from October 1, 2001, through December 31 2002, at

$20. For telehealth services provided on or after January 1 of each subsequent calendar year, the telehealth originating site facility fee is increased by the percentage increase in the MEI as defined in section 1842(i)(3) of the Act. The MEI increase for 2009 is 1.6 percent.

Therefore, for CY 2009, the payment amount for HCPCS code Q3014,

Telehealth originating site facility fee, is 80 percent of the lesser of the actual charge or $23.72.

The Medicare telehealth originating site facility fee and MEI increase by the applicable time period is shown in Table 45.

Table 45--The Medicare Telehealth Originating Site Facility Fee and MEI

Increase by the Applicable Time Period

MEI increase

Facility fee

(percent)

Period

$20.00.......................

N/A

10/01/2001-12/31/2002

$20.60.......................

3.0

01/01/2003-12/31/2003

$21.20.......................

2.9

01/01/2004-12/31/2004

$21.86.......................

3.1

01/01/2005-12/31/2005

$22.47.......................

2.8

01/01/2006-12/31/2006

$22.94.......................

2.1

01/01/2007-12/31/2007

$23.35.......................

1.8

01/01/2008-12/31/2008

$23.72.......................

1.6

01/01/2009-12/31/2009

XI. Payment for Certain Durable Medical Equipment, Prosthetics,

Orthotics, and Supplies (DMEPOS)--Services Excluded From Coverage

A. Low Vision Aid Exclusion 1. Background

Section 1862(a)(7) of the Act excludes payment under Medicare Part

A and Part B where ``expenses are for * * * eyeglasses (other than eyewear described in section 1861(s)(8) of the Act) or eye examinations for the purpose of prescribing, fitting, or changing eyeglasses, procedures performed (during the course of any eye examination) to determine the refractive state of the eyes * * *'' Section 411.15(b) excludes from coverage, eyeglasses and contact lenses, except for--

Post-surgical prosthetic lenses customarily used during convalescence for eye surgery in which the lens of the eye was removed

(for example, cataract surgery);

Prosthetic lenses for patients who lack the lens of the eye because of congenital absence or surgical removal; and

One pair of conventional eyeglasses or conventional contact lenses furnished after each cataract surgery during which an intraocular lens is inserted.

From as early as 1980, we have clarified that we viewed closed circuit visual aid systems and other low vision devices to be subject to the eyeglass coverage exclusion at section 1862(a)(7) of the Act. On

July 16, 1980, we conveyed from the Acting Director, Office of Coverage

Policy, Bureau of Program Policy, Health Care Financing Administration, to the Regional Administrator, San Francisco, an example of this clarification. We stated in a memorandum that closed circuit visual aid systems, in providing magnification serve the same function as eyeglasses, coverage of which is specifically excluded by Medicare law

Page 69910

(section 1862(a)(7) of the Act). This document explained that section 1862(a)(7) of the Act is an overriding statutory coverage exclusion which would apply even if these devices were determined to meet

Medicare's definition of durable medical equipment. Moreover, the

Medicare Appeals Council has recognized that video magnifiers, or closed circuit televisions (CCTVs), are subject to the eyeglass coverage exclusion at section 1862(a)(7) of the Act. However, we have never issued a regulation or national coverage decision (NCD) that specifically states that the eyeglass exclusion at section 1862(a)(7) of the Act applies to low vision aids. 2. Provisions of the Proposed Rule

In the Competitive Acquisition for Certain Durable Medical

Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) proposed rule

(hereinafter referred to as the May 1, 2006 proposed rule (71 FR 25654, at 25659 and 25687)), we proposed to revise Sec. 411.15(b), which provides certain specific exceptions to the eyeglass coverage exclusion, to expressly state the scope of the eyeglass exclusion. In proposing this revision, we were mindful that three United States

District courts found that the Act does not prohibit payment for video magnifiers. (Collins v. Thompson, No 2:03-cv-265-FtM-29SPC (M.D. Fla.

June 4, 2004); Davidson v. Thompson, No. Civ. 04-32 LFG (D.N.M. 2004);

Currier v. Thompson, 369 F. Supp. 2d 65 (D. Me. 2005)). We also noted that the Currier case recognized that the statute was ambiguous, and the Supreme Court has recognized that a prior judicial construction of an ambiguous statute does not categorically control an agency's contrary construction (National Cable & Telecommunications Association v. Brand X Internet Services, 545 U.S. 967, 982 (2005)).

We have a longstanding practice of denying claims for low visions aids and have stated in both judicial and administrative processes our position that low vision aids fall within the statutory eyeglass exclusion. The purpose of this final regulation is not to withdraw coverage of low vision aids but to codify in regulations our longstanding practice of not covering these devices.

In the May 1, 2006 proposed rule, we proposed to clarify under proposed Sec. 411.15(b) that the scope of the eyeglass coverage exclusion encompasses all devices irrespective of their size, form, or technological features that use one or more lenses to aid vision or provide magnification of images for impaired vision. This proposed regulatory provision would clarify that the statute does not support the interpretation that the term ``eyeglasses'' only applies to lenses supported by frames that pass around the nose and ears. The underlying technology and the function of eyeglasses are to use lenses to assist persons with impaired vision. Dorland's Illustrated Medical Dictionary

(28th Ed. 1994) defines ``eyeglass'' simply as a ``lens for aiding sight.'' Low vision aids depend on the use of a lens to aid vision. For example, computers can use lenses to enlarge print to help individuals who need visual assistance in reading. The Cleveland Clinic on its Web site, under the heading of ``Coping with Vision Loss'', lists examples of popular low vision aids. The examples include telescopic glasses, lenses that filter light, magnifying glasses, hand magnifiers, close- circuit television, and reading prisms.

We interpret the eyeglass exclusion at section 1862(a)(7) of the

Act as encompassing all of the various types of devices that use lenses for the correction of vision unless there is a statutory exception that allows for coverage, or the existing regulatory exceptions that remain unchanged at Sec. 411.15(b) allow coverage. For example, section 1861(s)(8) of the Act provides for one pair of conventional eyeglasses or contact lenses after each cataract surgery with insertion of an intraocular lens.

We noted that if the term ``eyeglasses'' as used at section 1862(a)(7) of the Act was interpreted to refer only to the exclusion of payment for lenses supported by frames that pass around the nose and ears, then the eyeglass exclusion would not apply to contact lenses and there would have been no reason for the Congress to make an exception to section 1862(a)(7) of the Act for contact lenses. However, the

Congress enacted the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508) (OBRA 90). Section 4153(b)(2)(B) of the OBRA 90 provides for an exception to section 1862(a)(7) of the Act that allows coverage of contact lenses furnished after cataract surgery with the insertion of an intraocular lens.

Considering sections 1862(a) and 1861(s) of the Act together indicates that the eyeglass exclusion also applies to contact lenses, except for contact lenses furnished under the specific conditions noted in section 1861(s) of the Act, that being, after each cataract surgery with the insertion of an intraocular lens. By applying the eyeglass exclusion to contact lenses, we believe that not only does the plain language of the statute reinforce our interpretation that the exclusion encompasses the use of any device that uses a lens to aid vision, and is not limited to just lenses supported by frames that pass around the nose and ears, but that this interpretation best captures the Congress' intent.

Also, when referring to ``conventional eyeglasses,'' section 1861(s)(8) of the Act is affirming that the term ``eyeglasses'' has a wider application than ``conventional eyeglasses'' and the terms

``conventional eyeglasses'' and ``eyeglasses'' are not synonymous in the statute. Moreover, the statute uses the terms ``eyewear'' and

``contact lenses'' in reference to the eyeglass exclusion, further suggesting that these terms are not synonymous.

Our interpretation of the term eyeglasses is consistent with the regulatory language used for the optional benefit in the Medicaid program under Sec. 440.120(d) for eyeglasses. Section 1905(a)(12) of the Act defines the term ``medical assistance'' to include eyeglasses as an optional service. The Medicaid regulations implementing this section of the statute defines eyeglasses to mean ``lenses, including frames, and other aids to vision * * * '' Therefore, in setting program parameters, both Medicaid and Medicare are consistently interpreting in regulations a statutory reference to eyeglasses as including low vision aids.

Although the technology of using lenses to aid low vision may continue to be improved with new innovations, such as contact lenses, progressive lenses, and low vision aids, this does not exempt the new technology from the eyeglass exclusion. The adaptation of the vision aid technology does not change the essential nature of the device: a video magnifier is a device that utilizes a lens to enhance vision. We believe this interpretation is consistent with the decision in Warder v. Shalala, 149 F 3d 73 (1st Cir. 1998), in which the United States

Court of Appeals for the First Circuit held, in part, that the

Secretary's classification of a seating system as DME, even though it was a technologically advanced seating system, was supported by the

Medicare statute and regulations. In reaching this conclusion, the

Court stated that the Secretary could conclude that the seating system met the definition of DME, which ``unequivocally includes

`wheelchairs,' '' since the system served the same (as well as additional) functions as a wheelchair. We believe this case affirms the principle that the Secretary has the discretion to interpret the statute and to assign a product to a particular Medicare category even when

Page 69911

this will result in non-coverage determinations by Medicare. 3. Public Comments Received on the Proposed Rule

Comment: Several commenters urged that low vision aids should be covered for individuals with vision loss to help individuals to remain as independent as possible, to ensure quality of life, to conduct activities of daily living safely and effectively, and to avoid placement in assistive living or nursing homes. The commenters believe the use of prescribed low vision aids would help avoid greater expenses to the Medicare program due to reduced illnesses, injuries, and loss of independence. Several commenters indicated that they did not have sufficient funds to obtain these items without Medicare coverage.

Response: We understand and can appreciate the commenters' concerns. However, the Medicare statute does not provide for the coverage of every service or item that may increase an individual's quality of life or which may provide a medical benefit. For example, in addition to excluding eyeglasses from coverage, the Act also generally excludes coverage of dental services, orthopedic shoes, and hearing aids. We understand that eyeglasses aid individuals in conducting activities of daily living; however, the Medicare statute makes only limited exceptions to the statutory eyeglass coverage exclusion, such as for ``conventional eyeglasses and contact lenses,'' in certain cases. Moreover, we believe the appropriate regulatory interpretation of this statutory exclusion is to remain consistent with our longstanding views, and finalize the proposed regulation without modification.

Comment: Some commenters stated that the regulation does not rely on the plain language of the statute. The commenters suggested that eyeglasses and low vision devices are dissimilar: eyeglasses are optical systems to aid the vision of a person who essentially has normal vision, while low vision aids are prosthetic in nature for persons whose vision is impaired in other ways than refractive error.

The commenters believe that the regulation fails to distinguish between lenses that correct refractive errors in eyes with normal visual function and lenses and devices that enlarge images to make them visible to eyes with subnormal visual function. The commenters also stated that the regulation is not in accord with certain established case law, that it conflicts with Congressional intent, and ignores other Medicare regulations and definitions that could be used to cover low vision aids as DME or prosthetic devices.

Response: As a general matter, we disagree with the commenters' concerns raised above. First, we continue to believe that our interpretation is consistent with the plain language of the Medicare statute, and alternatively, if the statute is ambiguous to this point, we believe our interpretation best captures the Congress' intent and is a reasonable and permissible interpretation.

Second, eyeglasses and low vision aids are not dissimilar, but the same, in that, they both use lenses to aid poor vision or provide magnification of images for impaired vision. The operative component of the eyeglass is the lens because it is the component that provides visual improvement. It may be useful to consider standard dictionary definitions of the word ``eyeglass.'' For example, the Webster's Third

New Int. Dictionary (1976) defines ``eyeglass'' to include the eyepiece of an optical instrument (as in a microscope or telescope). Also, the

Webster's New Collegiate Dictionary (8th Ed, 1979) includes eyepiece as its first definition for eyeglass. It defines eyepiece as the lens or combination of lenses at the eye end of an optical instrument.

As can be clearly seen through the dictionary definitions, any type of eyeglass, conventional or otherwise, is a device used for aiding sight. Lenses used with low vision aids are for the purpose of improving vision, as are the lenses used with conventional eyeglasses.

While we understand that some may suggest that a more narrow reading of the statutory exclusion may be appropriate, we disagree and believe that our interpretation is a reasonable and permissible construction of the statutory exclusion, and one that best matches the

Congress' intent.

In addition to the plain language of the Medicare statutory exclusion itself, language in other sections of the statute further supports our interpretation. For example, in section 1862(a)(7) of the

Act, the Congress makes an exception to the eyeglass exclusion for certain conventional eyeglasses and contact lenses used after cataract surgery. This exception indicates that the eyeglass exclusion applies to more than lenses in frames worn around the nose and ears. In referring to the eyeglass exclusion, the Medicare statute uses various terms, such as eyeglasses, eyewear, conventional eyeglasses and contact lenses, which strongly indicates that the eyeglass exclusion applies to more than just conventional eyeglasses. Additional evidence of

Congressional intent regarding the meaning of the term ``eyeglasses'' can be found in the conference report accompanying the original legislation in 1965 (S. Rep. No. 89-404, 49). Although the original statutory language referred to eyeglasses, the conference report also referred to contact lenses, suggesting that the Congress did not intend to construe the term narrowly.

We also note that there is nothing in either the Medicare statutory language of the eyeglass coverage exclusion or the accompanying legislative history to suggest that the exclusion is limited to lenses used to correct refractive errors or other types of specific visual problems; rather, it is stated without reference to any particular types of visual problems.

Additionally, to the extent there is some ambiguity (as noted above in our discussion of the Currier case, where the court noted that ambiguity exists with respect to this statutory exclusion and low vision aids), the Supreme Court recognizes that a prior judicial construction of an ambiguous statute does not categorically control an agency's contrary construction. As noted above, we understand that some may believe a more narrow interpretation would be appropriate in this instance. We disagree and continue to believe we have interpreted the

Medicare statute in a way that best captures the Congress's intent and that our interpretation is a reasonable and permissible reading of the statutory exclusion.

Furthermore, we have followed the necessary procedures set forth under the Administrative Procedures Act for agencies to follow in establishing interpretive rules to ensure that this regulatory clarification of our longstanding Medicare policy has been given the appropriate consideration and review.

Finally, as noted in more detail below, if an item or service falls within a benefit category, it must not be otherwise excluded, in order for coverage to be considered. Thus, whether an item that falls within the scope of statutory exclusion clarified by this regulation falls within a defined Medicare benefit category, does not alter the analysis as to whether the statutory exclusion for eyeglasses may apply.

Comment: Some commenters believe the regulation does not consider advancements in medical technology and would automatically deny coverage for any new technology designed to assist individuals with vision impairments. As a result, the commenters stated this regulation creates a disincentive for manufacturers

Page 69912

and innovators to develop new and progressive vision technology.

Response: We disagree with the commenters that this regulation creates a disincentive for manufacturers and innovators to develop new and progressive vision technology. As noted above, it is true that new medical advancements and new technologies in the area of vision impairment may fall within the scope of the statutory exclusion clarified in this regulation and coverage may be prohibited under

Medicare.

We do not automatically deny coverage for technologically improved items or services, instead, as a general matter, we cover technologically improved items or services if all coverage requirements are met. Many items, however, are not covered by Medicare, yet the relevant industries continue to develop and achieve major advancements in technology. For example, while we do not cover dental services or hearing aids, there continue to be advances in the furnishing of dental care and technological advances in the use of hearing aids. In addition, Medicare has had a longstanding history of not covering low vision aids, yet, manufacturers continue to make technological improvements in this area. Moreover, there are existing incentives beyond Medicare reimbursement that will continue to encourage manufacturers and innovators to improve vision technology.

Comment: Other commenters believe it is inconsistent and discriminatory for Medicare to cover wheelchairs to assist individuals with impaired mobility and not to cover low vision aids to assist individuals with impaired vision.

Response: In order to be covered under Medicare, an item or service must fall within one or more benefit categories contained within Part A or Part B, and must not be otherwise excluded from coverage.

Wheelchairs, which may assist individuals with impaired mobility, fall within the defined benefit category for durable medical equipment under section 1861(n) of the Act, and are not otherwise excluded from coverage under section 1862(a) of the Act. Low vision aids, on the other hand, are excluded from coverage under section 1862(a)(7) of the

Act and we must comply with this provision.

Comment: Some commenters suggested that CMS allow for a more fully vetted process prior to any rule for or against low vision aid coverage.

Response: We are issuing this final regulation in accordance with the requirements of the Administrative Procedures Act (the APA). On May 1, 2006, we issued a proposed rule that discussed the background and rationale pertaining to our proposed provisions to apply the eyeglass coverage exclusion to low vision aids. In accordance with section 1871(b)(1) of the Act, we proposed this regulation pursuant to a 60-day public comment period. After reviewing and considering the public comments, relevant case law, and our existing policies on this issue, we are issuing this final rule without modification. We believe it sets forth a reasonable and permissible interpretation of the Medicare statutory eyeglass coverage exclusion.

Comment: Commenters expressed concern that the use of assistive low vision aids associated with rehabilitative therapy services, which are identified by Medicare-covered Current Procedural Terminology (CPT) codes, such as CPT code 97535, would no longer be covered by Medicare if subjected to the eyeglass exclusion.

Response: Low vision aids are not covered, items based on the statutory eyeglass exclusion. A practitioner is paid for his or her professional services. Supplies and instruments used in providing those services are not paid for separately, rather payment is made based on the practitioner's PEs. 4. Provisions of the Final Rule

After consideration of the public comments received, we are finalizing Sec. 411.15(b) without modification.

B. Replacement of Reasonable Charge Methodology by Fee Schedules for

Therapeutic Shoes

We are finalizing proposed Sec. 414.228(c) to codify that the

Medicare fee schedule amounts for therapeutic shoes, inserts, and shoe modifications are established in accordance with the methodology specified in sections 1833(o) and 1834(h) of the Act.

Section 627 of the MMA mandated fee schedule amounts for therapeutic shoes and inserts effective January 1, 2005, calculated using the prosthetic and orthotic fee schedule methodology in section 1834(h) of the Act. In accordance with section 627 of the MMA, fee schedule amounts for therapeutic shoes, inserts and shoe modifications were established and added to the DMEPOS fee schedule through program instructions, effective January 1, 2005.

In our May 1, 2006 proposed rule (71 FR 25654), we proposed to add

Sec. 414.228(c) to specify that the Medicare fee schedule amounts for therapeutic shoes, inserts, and shoe modifications are established in accordance with the methodology specified in sections 1833(o) and 1834(h) of the Act. Section 627 of the MMA amended section 1833(o)(2) of the Act to require implementation of fee schedule amounts, effective

January 1, 2005, for the purpose of determining payment for custom molded shoes, extra-depth shoes, and inserts (collectively,

``therapeutic shoes''). Section 627 of the MMA was initially implemented through program instructions, and on January 1, 2005,

Medicare began paying for therapeutic shoes, inserts, and shoe modifications based on fee schedule amounts determined in accordance with section 1834(h) of the Act and 42 CFR part 414, subpart D of our regulations.

We did not receive any comments on our proposal to add Sec. 414.228(c) to 42 CFR part 414, subpart D of our regulations. Therefore, we are finalizing proposed Sec. 414.228(c) regarding the methodology used to establish fee schedule amounts for therapeutic shoes, inserts and shoe modifications.

XII. Provisions of the Final Rule

The provisions of this final rule with comment period restate the provisions of the CY 2009 PFS proposed rule, except as noted elsewhere in the preamble.

XIII. Waiver of Proposed Rulemaking and Delay in Effective Date

We ordinarily publish a notice of proposed rulemaking in the

Federal Register and invite public comment on the proposed rule. The notice of proposed rulemaking includes a reference to the legal authority under which the rule is proposed, and the terms and substances of the proposed rule or a description of the subjects and issues involved. This procedure can be waived, however, if an agency finds good cause that a notice-and-comment procedure is impracticable, unnecessary, or contrary to the public interest and incorporates a statement of the finding and its reasons in the rule issued.

We utilize HCPCS codes for Medicare payment purposes. The HCPCS is a national drug coding system comprised of Level I (CPT) codes and

Level II (HCPCS National Codes) that are intended to provide uniformity to coding procedures, services, and supplies across all types of medical providers and suppliers. Level I (CPT) codes are copyrighted by the AMA and consist of several categories, including Category I codes which are 5-digit numeric codes, and Category III codes which are temporary codes to track emerging technology, services, and procedures.

Page 69913

The AMA issues an annual update of the CPT code set each Fall, with

January 1 as the effective date for implementing the updated CPT codes.

The HCPCS, including both Level I and Level II codes, is similarly updated annually on a CY basis. Annual coding changes are not available to the public until the Fall immediately preceding the annual January update of the PFS. Because of the timing of the release of these new codes, it is impracticable for CMS to provide prior notice and solicit comment on these codes and the RVUs assigned to them in advance of publication of the final rule that implements the PFS. Yet, it is imperative that these coding changes be accounted for and recognized timely under the PFS for payment because services represented by these codes will be provided to Medicare beneficiaries by physicians during the CY in which they become effective. Moreover, regulations implementing HIPAA (42 CFR parts 160 and 162) require that the HCPCS be used to report health care services, including services paid under the

PFS. We also assign interim RVUs to any new codes based on a review of the RUC recommendations for valuing these services. By reviewing these

RUC recommendations for the new codes, we are able to assign RVUs to services based on input from the medical community and to establish payment for them, on an interim basis, that corresponds to the relative resources associated with furnishing the services. If we did not assign

RVUs to new codes on an interim basis, the alternative would be to either not pay for these services during the initial CY or have each carrier establish a payment rate for these new codes. We believe both of these alternatives are contrary to the public interest, particularly since the RUC process allows for an assessment of the valuation of these services by the medical community prior to our establishing payment for these codes on an interim basis. Therefore, we believe it would be contrary to the public interest to delay establishment of fee schedule payment amounts for these codes.

For the reasons outlined above in this section, we find good cause to waive the notice of proposed rulemaking for the interim RVUs for selected procedure codes identified in Addendum C and to establish RVUs for these codes on an interim final basis. We are providing a 60-day public comment period.

Section IV.C. of this final rule with comment discusses the identification and review of 204 potentially misvalued codes by a workgroup of the AMA RUC, as well as our review and decisions regarding the AMA RUC workgroup's recommendations. The AMA RUC submitted several recommendations for misvalued codes in May 2008 and the remainder of their recommendations for misvalued codes in October 2008. Due to the timing of the May 2008 AMA RUC recommendations, it was impracticable for CMS to adequately evaluate and solicit public comment prior to this final rule with comment period. We believe it is in the public interest to implement the revised RVUs for the 61 codes that were identified as misvalued, and that have been reviewed and re-evaluated by the AMA RUC workgroup, on an interim final basis for CY 2009. These revisions will establish a more appropriate payment for these services, some of which changed significantly since they were originally valued. The revisions of RVUs for these codes will establish a more appropriate payment that better corresponds to the relative resources associated with furnishing these services. A delay in implementing revised values for these misvalued codes would not only perpetuate the known misvaluation for these services, it would also perpetuate a distortion in the payment for other services under the PFS. Implementing the changes now allows for a more equitable distribution of payments across all PFS services.

We believe a delay in implementation of these revisions would be contrary to the public interest, particularly since the AMA RUC process allows for an assessment of the valuation of these services by the medical community prior to the AMA RUC's recommendation to CMS.

For the reasons described above, we find good cause to waive notice and comment procedures with respect to the misvalued codes identified in Table 26, and to revise RVUs for these codes on an interim final basis. We are providing a 60-day public comment period.

Sections III. and VI.B. of this final rule with comment period also address certain provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275) which became law after publication of the CY 2009 PFS proposed rule. Except as noted further below, we consider these provisions to be self-implementing. We are revising our policies and regulations as described in this final rule with comment period in order to conform them to the statutory amendments. Because these revisions are in accordance with explicit statutory amendments, we find that notice and comment procedures are unnecessary for their implementation. Therefore, we find good cause to waive notice and comment procedures with respect to the changes in policy and regulations to effectuate the self-implementing provisions of the MIPPA as described in this final rule with comment period.

Section 131(c) of the MIPPA requires the Secretary to implement a

Physician Feedback Program no later than January 1, 2009. Under the program, the Secretary must use claims data to provide confidential reports to physicians that measure resources involved in furnishing care to individuals (and, if determined appropriate, the reports can also include information about the quality of care furnished). Although this provision is self-implementing in certain respects, especially given that many elements of this program are already in place as a result of our previous data analysis and reporting efforts, we would ordinarily engage in notice and comment rulemaking to establish other aspects of this program. To the extent this provision is not self- implementing, we find good cause to waive notice and comment rulemaking because it would be contrary to the public interest to delay implementation of this program. Moreover, we note that the confidential feedback reporting will serve informational purposes and will not affect any rights or obligations under the Medicare program.

Section 144(b) of the MIPPA repeals the requirement that an oxygen supplier transfer title to oxygen equipment to the beneficiary after a 36-month rental period. In its place, section 144(b) of the MIPPA establishes a 36-month rental cap and sets forth new rules for furnishing oxygen and oxygen equipment after the 36-month period. The current oxygen payment regulations reflect the previous transfer of title requirements, and we are revising these rules to reflect the changes set forth in section 144(b) of the MIPPA.

These changes are largely self-implementing. Section 1834(a)(5)(F)(ii)(I) of the Act, as amended by MIPPA, requires suppliers to continue to furnish oxygen equipment following the 36- month rental period, and section 1834(a)(5)(F)(ii)(II) of the Act mandates continued Medicare payments for oxygen contents following the 36-month rental period. When read in conjunction with section 1834(a)(5)(F)(ii)(II) of the Act, we interpret the mandate in section 1834(a)(5)(F)(ii)(I) of the Act to include oxygen contents, as well as oxygen equipment, given the nature of this benefit and the requirement that Medicare continue to pay for oxygen contents following the 36- month rental

Page 69914

period. To the extent these subsections are not self-implementing, we find good cause to waive notice and comment rulemaking as contrary to the public interest, because timely implementation of these provisions is necessary to ensure that beneficiaries' oxygen treatment--which for many beneficiaries includes both oxygen equipment and contents-- continues uninterrupted after January 1, 2009.

Subsection 1834(a)(5)(F)(ii)(III) of the Act, as amended by MIPPA, authorizes payments for maintenance and servicing of oxygen equipment furnished after the 36-month rental period if the Secretary determines such payments are reasonable and necessary. As set forth in section

III. J. of this preamble, we have determined that certain routine maintenance and servicing payments are reasonable and necessary to protect Medicare beneficiaries from malfunctioning oxygen equipment.

For the reasons described above, we believe the completion of notice and comment rulemaking would prevent the timely implementation of payment for certain maintenance and servicing of oxygen equipment that we have determined to be necessary for the safe use of oxygen equipment by Medicare beneficiaries, and that any such delay would be contrary to the public interest. Therefore, we find good cause to waive the notice of proposed rulemaking with respect to implementation of subsection 1834(a)(5)(F)(ii)(III) of the Act.

Section 149 of the MIPPA amended section 1834(m)(4)(C)(ii) of the

Act to add certain entities as originating sites for purposes of

Medicare telehealth services effective January 1, 2009: A hospital- based or critical access hospital-based (CAH-based) renal dialysis center (including satellites); a skilled nursing facility (as defined in section 1819(a) of the Act); and a community mental health center

(as defined in section 1861(ff)(3)(B) of the Act). Section 149 of the

MIPPA also amended section 1888(e)(2)(A)(ii) of the Act to exclude telehealth services furnished under section 1834(m)(4)(C)(ii)(VII) of the Act from the consolidated billing provisions of the skilled nursing facility prospective payment system (SNF PPS). Apart from adding certain entities as originating sites for payment of telehealth services, section 149 of the MIPPA did not change the existing telehealth eligibility criteria, or payment and billing requirements related to telehealth services. Thus, the new authority for these entities to serve as originating sites for Medicare telehealth services is largely self-implementing. However, there are some operational and payment issues that arise as to which we would ordinarily engage in notice and comment rulemaking. In section III. M. of this final rule with comment period, we describe certain limitations on the types of services for which a Medicare telehealth payment will be made when these entities serve as the originating site. These requirements are similar to those in place under current policies for the existing list of telehealth originating sites, but are also tailored to address the particular characteristics of the newly added originating sites. It is necessary to address these requirements in a timely manner in order to avoid potential duplicate billing and payment, and to ensure that facilities appropriately furnish the requisite scope of services for which payment is included in their bundled or prospective payment. For the reasons described above, we believe that completion of notice and comment rulemaking prior to adopting these policies would delay timely implementation of policies that are important to quality care and program integrity. Therefore, to the extent these requirements are not self-implementing, we find good cause to waive notice and comment rulemaking as a delay in implementation would be contrary to the public interest.

As detailed above in this section, we are implementing certain aspects of sections 131(c), 144(b), and 149 of the MIPPA as described in sections III.C., III.J., and III.M. (respectively) of this final rule with comment period on an interim final basis for CY 2009, and include a 60-day comment period.

XIV. Collection of Information Requirements

Under the Paperwork Reduction Act of 1995, we are required to provide 30-day notice in the Federal Register and solicit public comment before a collection of information (COI) requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork

Reduction Act of 1995 requires that we solicit comment on the following issues:

The need for the information collection and its usefulness in carrying out the proper functions of our agency.

The accuracy of our estimate of the information collection burden.

The quality, utility, and clarity of the information to be collected.

Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.

The collection of information section for this final rule with comment period contains the discussion of the information collection requirements as it appeared in the CY 2008 PFS proposed rule (73 FR 38502), with updated information included as necessary. In addition, we have included a new discussion of the information collection requirements associated with the Electronic Prescribing (E-Prescribing)

Incentive Program, as detailed in section II.O2. of the preamble of this final rule with comment period.

A. ICRs Regarding Independent Diagnostic Testing Facility (Sec. 410.33)

Section 410.33(j) initially proposed that a physician or nonphysician practitioner organization furnishing diagnostic testing services, except diagnostic mammography services, must enroll as an

IDTF for each practice location furnishing these services. However, we have removed this requirement and the associated paperwork burden from this final rule with comment period.

For mobile units furnishing diagnostic testing services that are not enrolled in the Medicare program to enroll in the program, they must complete a Medicare enrollment application, the CMS-855B, and attachment 2 of the enrollment application. The burden associated with completing and submitting this application is currently approved under

OMB control number 0938-0685 with an expiration date of February 28, 2011. We believe that most of these mobile entities are already enrolled as IDTFs, as required in Sec. 410.33(g).

However, we have no way to accurately quantify the burden because we cannot estimate the number of this type of requests that we may receive. We did not receive any public comments to assist us in our burden analysis. We also recognize that we will not be able to determine the number of the IDTFs that are billing only under arrangement with a hospital. Therefore, while we acknowledge that there is a burden associated with this provision, we also acknowledge that we have no way to quantify this provision's burden. For that reason, we are assigning 1 token burden hour to this requirement until such a time that we can conduct an accurate burden analysis for this information collection requirement.

Page 69915

B. ICRs Regarding Exception to the Referral Prohibition Related to

Compensation Arrangements (Sec. 411.357)

As discussed in section II.N.1. of the preamble of this final rule with comment period, we are not finalizing the exception for incentive payment and shared savings programs contained in Sec. 411.357(x).

Consequently, we have removed all discussion of the associated information collection requirements.

C. ICRs Regarding Dispute Resolution and Process for Suspension or

Termination of Approved CAP Contract and Termination or Physician

Participation Under Exigent Circumstances (Sec. 414.917)

Section 414.917(b)(4) states that an approved CAP vendor may appeal a termination by requesting a reconsideration. The burden associated with this requirement is the time and effort necessary to submit a reconsideration request to CMS. While this requirement is subject to the PRA, the associated burden is exempt under 5 CFR 1320.4(a)(2).

Information collected as part of an administrative action is not subject to the PRA.

In section II.F.2 of this final rule with comment period, we discuss the postponement of the CAP for CY 2009.

D. ICRs Regarding Additional Provider and Supplier Requirements for

Enrolling and Maintaining Active Enrollment Status in the Medicare

Program (Sec. 424.516)

Section 424.516(d) discusses the reporting requirements for physician groups/organizations, physicians and NPPs. Specifically, the aforementioned providers must report to CMS, within 30 days the information listed in Sec. 424.516(d)(1). Additionally, all other changes in enrollment must be reported within 90 days.

Section 424.516(e) addresses the reporting requirements for all other providers and suppliers. Providers not mentioned in Sec. 424.516(a) through (d) must report to CMS, within 30 days, changes of ownership, including changes in authorized official(s) or delegated official(s). All other changes in enrollment must be reported within 90 days.

The burden associated with the requirements contained in Sec. 424.516(d) through (e) is the time and effort necessary to report the applicable information to CMS. These provisions change the reporting timeframes for the actions but not the burden associated with the requirement. While this requirement is subject to the PRA, we have no way to accurately quantify the number of submissions. Each submission will be reviewed on a case-by-case basis.

Section Sec. 424.516(d) states providers or suppliers are required to maintain ordering and referring documentation, including the NPI, received from a physician or eligible NPP for 7 years from the date of service. As discussed in Section II.I.5 of this final rule with comment period, we are not adopting the proposed record retention requirement of 10 years from the date of service. Physicians and NPPs are currently required to maintain written ordering and referring documentation for 7 years from the date of service within the CMS Program Integrity Manual.

The burden associated with these recordkeeping requirements is the time and effort associated with maintaining the aforementioned documentation for 7 years, which is merely the codification of the requirements that already exist. While these requirements are subject to the PRA, we believe the burden is exempt because the requirement is part of a usual and customary business practice. As stated in 5 CFR 1320.3(b)(2), the time, effort, and financial resources necessary to comply with a COI that would be incurred by persons in the normal course of their activities (for example, in compiling and maintaining business records) is not subject to the PRA.

Table 46--Estimated Annual Reporting and Recordkeeping Burden

OMB control

Burden per

Total annual

Regulation section(s)

number

Respondents

Responses

response (hours) burden (hours)

Sec. 410.33............................................

0938-0685

400,000

2.5

1,001,503

Total................................................ .................

400,000

2.5

1,001,503

This final rule with comment period imposes COI requirements as outlined in the regulation text and specified above. However, this rule also makes reference to several associated information collections that are not discussed in the regulation text which have already received

OMB approval.

These include the following:

Part B Drug Payment

Section II.F.1 of the preamble of this final rule with comment period discusses payment for Medicare Part B drugs and biologicals under the ASP methodology. Drug manufacturers are required to submit

ASP data to us on a quarterly basis. The collection of ASP data imposes a reporting requirement on the public. The burden associated with this requirement is the time and effort required by manufacturers of

Medicare Part B drugs and biologicals to calculate, record, and submit the required data to CMS. While the burden associated with this requirement is subject to the PRA, it is currently approved under OMB control number 0938-0921, with an expiration date of May 31, 2009.

Competitive Acquisition Program (CAP)

Section II.F.2. of this final rule with comment period discusses the Part B CAP issues. While we are not imposing any new burden, it should be noted that all of the information collection components of the CAP have been reviewed and approved by OMB. They are approved under

OMB control numbers 0938-0987, 0938-0955, and 0938-0954 with expiration dates of April 30, 2009, August 31, 2009, and June 30, 2011, respectively.

Physician Quality Reporting Initiative (PQRI)

Section II.O1. of this final rule with comment period discusses the background of the PQRI and provides information about the measures available to eligible professionals who choose to participate in PQRI.

Section 1848(k)(1) of the Act requires the Secretary to implement a system for the reporting by eligible professionals of data on quality measures. We are requesting OMB's emergency review and approval of the information collections referenced below. Emergency review and approval is necessary to meet the statutory effective date of January 1, 2009.

Page 69916

As stated in section II.O1.a.ii., eligible professionals include physicians, other practitioners as described in section 1842(b)(18)(c) of the Act, physical and occupational therapists, qualified speech- language pathologists, and qualified audiologists. Eligible professionals may choose whether to participate and, to the extent they satisfactorily submit data on quality measures for covered professional services, they can qualify to receive an incentive payment. To qualify to receive an incentive payment for 2009, the eligible professional must meet one of the criteria for satisfactory reporting described in section II.O1.b. of the preamble.

The burden associated with the requirements of this voluntary reporting initiative is the time and effort associated with eligible professionals identifying applicable PQRI quality measures for which they can report the necessary information. We have no way to accurately quantify the burden because it would vary with each eligible professional by the number of measures applicable to the eligible professional, the eligible professional's familiarity and understanding of the PQRI, and experience with participating in the PQRI. In addition, eligible professionals may employ different methods for incorporating the use of quality data codes into the office work flows.

Therefore, we will assign 3 hours as the amount of time needed for eligible professionals to review the PQRI quality measures, identify the applicable measures for which they can report the necessary information, and incorporate the use of quality data codes into the office work flows. Information from the Physician Voluntary Reporting

Program (PVRP) indicated an average labor cost of $50 per hour. Thus, we estimate the cost for an eligible professional to review the PQRI quality measures, identify the applicable measures for which they can report the necessary information, and incorporate the use of quality data codes into the office work flows to be approximately $150 per eligible professional ($50 per hour x 3 hours). We expect the ongoing costs associated with PQRI participation to decline based on an eligible professional's familiarity with and understanding of the PQRI, experience with participating in the PQRI, and increased efforts by CMS and stakeholders to disseminate useful educational resources and best practices.

In addition, for claims-based reporting, eligible professionals must gather the required information, select the appropriate quality data codes, and include the appropriate quality data codes on the claims they submit for payment. The PQRI will collect quality-data codes as additional (optional) line items on the existing HIPAA transaction 837-P and/or CMS Form 1500. We do not anticipate any new forms and no modifications to the existing transaction or form. We also do not anticipate changes to the 837-P or CMS Form 1500 for CY 2009.

Because this is a voluntary program, it is impossible to estimate with any degree of accuracy how many eligible professionals will opt to participate in the PQRI in CY 2009. Preliminary results from the 2007

PQRI (the first year of PQRI reporting) indicate that of approximately 619,000 unique individual eligible professionals, approximately 101,000 unique individual eligible professionals, or 16 percent, attempted to submit PQRI quality measures data in 2007. Therefore, for purposes of conducting a burden analysis for the 2009 PQRI, we will assume that all eligible professionals who attempted to participate in the 2007 PQRI will also attempt to participate in the 2009 PQRI.

Moreover, the time needed for an eligible professional to review the quality measures and other information, select measures applicable to his or her patients and the services he or she furnishes to them, and incorporate the use of quality data codes into the office work flows is expected to vary along with the number of measures that are potentially applicable to a given professional's practice. Since eligible professionals are generally required to report on at least 3 measures to earn a PQRI incentive, we will assume that each eligible professional who attempts to submit PQRI quality measures data is attempting to earn a PQRI incentive payment and that each eligible professional reports on an average of 3 measures for this burden analysis.

Based on our experience with the PVRP, we estimate that the time needed to perform all the steps necessary to report each measure (that is, reporting the relevant quality data code(s) for a measure) on claims ranges from 15 seconds (0.25 minutes) to over 12 minutes for complicated cases and/or measures, with the median time being 1.75 minutes. Information from the PVRP indicates that the cost associated with this burden ranges from $0.21 in labor time to about $10.06 in labor time for more complicated cases and/or measures, with the cost for the median practice being $0.90.

The total estimated annual burden for this requirement will also vary along with the volume of claims on which quality data are reported. Preliminary results from the 2007 PQRI indicate that eligible professionals reported on 1 to 3,331 eligible instances per measure.

For all 2007 PQRI measures, the median number of eligible instances reported on per measure was less than 60. On average, the median number of eligible instances reported on per measure was about 9. Therefore, for this burden analysis, we estimate for each measure on which an eligible professional reports, the eligible professional reports the quality data on 9 cases.

Based on the assumptions discussed above, we estimate the total annual burden per eligible professional associated with claims-based reporting to range from 186.75 minutes, or 3.1 hours [(0.25 minutes per measure x 3 measures x 9 cases per measure) + 3 hours] to 504 minutes, or 8.4 hours [(12 minutes per measure x 3 measures x 9 cases per measure) + 3 hours]. We estimate the total annual cost per eligible professional associated with claims-based reporting to range from

$155.67 [($0.21 per measure x 3 measures x 9 cases per measure) + $150] to $421.62 [($10.06 per measure x 3 measures x 9 cases per measure) +

$150].

For registry-based reporting, there would be no additional burden for eligible professionals to report data to a registry as eligible professionals more than likely would already be reporting data to the registry. Little, if any, additional data would need to be reported to the registry for purposes of participation in the 2009 PQRI. However, eligible professionals would need to authorize or instruct the registry to submit quality measures results and numerator and denominator data on quality measures to CMS on their behalf. We estimate that the time and effort associated with this would be approximately 5 minutes for each eligible professional that wishes to authorize or instruct the registry to submit quality measures results and numerator and denominator data on quality measures to CMS on their behalf.

Registries interested in submitting quality measures results and numerator and denominator data on quality measures to CMS on their participants' behalf would need to complete a self-nomination process in order to be considered ``qualified'' to submit on behalf of eligible professionals.

The burden associated with the registry-based submission requirements of this voluntary reporting initiative is the time and effort associated with the registry calculating quality measure results from the data submitted to the

Page 69917

registry by its participants and submitting the quality measures results and numerator and denominator data on quality measures to CMS on behalf of their participants. The time needed for a registry to review the quality measures and other information, calculate the measures results, and submit the measures results and numerator and denominator data on the quality measures on their participants' behalf is expected to vary along with the number of eligible professionals reporting data to the registry and the number of applicable measures.

However, we believe that registries already perform many of these activities for their participants. The number of measures that the registry intends to report to CMS and how similar the registry's measures are to CMS' PQRI measures will determine the time burden to the registry.

We are not finalizing our proposal to allow eligible professionals to submit clinical quality data extracted from electronic health records (EHRs) for purposes of receiving an incentive payment for the 2009 PQRI.

The Electronic Prescribing (E-Prescribing) Incentive Program

It is impossible to estimate with any degree of accuracy how many eligible professionals will opt to participate in the e-prescribing incentive program in CY 2009. However, if we assume that every eligible professional who attempted to participate in the 2007 PQRI will also attempt to participate in the 2009 E-Prescribing Incentive Program, then we can estimate that approximately 101,000 unique individual eligible professionals will participate in the 2009 E-Prescribing

Incentive Program.

Section II.O2. of the preamble discusses the background of a new incentive program that is available to eligible professionals in addition to the PQRI. This incentive program is known as the e- prescribing incentive program. Section II.O2. of the preamble provides information on how eligible professionals can qualify to be considered a successful electronic prescriber in 2009 in order to earn an incentive payment. Similar to the PQRI, the e-prescribing incentive program is a voluntary initiative. Eligible professionals may choose whether to participate and, to the extent they meet (1) certain thresholds with respect to the volume of covered professional services furnished and (2) the criteria to be considered a successful electronic prescriber described in section II.O2. of this final rule with comment period, they can qualify to receive an incentive payment.

Similar to claims-based reporting for the PQRI, we estimate the burden associated with the requirements of this new incentive program is the time and effort associated with eligible professionals determining whether the quality measure is applicable to them, gathering the required information, selecting the appropriate quality data codes, and including the appropriate quality data codes on the claims they submit for payment. Since the e-prescribing program consists of only 1 quality measure, we will assign 1 hour as the amount of time needed for eligible professionals to review the e-prescribing measure and incorporate the use of quality data codes into the office work flows. At an average cost of approximately $50 per hour, we estimate the total cost to eligible professionals for reviewing the e- prescribing measure and incorporating the use of quality data codes into the office work flows to be approximately $50 ($50 per hour x 1 hour).

The quality-data codes will be collected as additional (optional) line items on the existing HIPAA transaction 837-P and/or CMS Form 1500. We do not anticipate any new forms and no modifications to the existing transaction or form. We also do not anticipate changes to the 837-P or CMS Form 1500 for CY 2009. Based on our experience with the

PVRP described above, we estimate that the time needed to perform all the steps necessary to report the e-prescribing measure to be 1.75 minutes. We also estimate the cost to perform all the steps necessary to report the e-prescribing measure to be $0.90 based on the experience with the PVRP described above.

The total estimated annual burden for this requirement will also vary along with the volume of claims on which quality data is reported.

Based on preliminary results from the 2007 PQRI described above and the fact that the measure's denominator consists of only billing codes for professional services, we estimate that each eligible professional reports the quality data on 60 cases for the e-prescribing measure.

Therefore, we estimate the total annual burden per eligible professional associated with claims-based reporting of the e- prescribing measure to be 165 minutes, or 2.75 hours [(1.75 minutes per measure x 1 measure x 60 cases per measure) + 1 hour]. The total estimated cost per eligible professional to report the e-prescribing measure is estimated to be $104 [($0.90 per measure x 1 measure x 60 cases per measure) + $50].

If you choose to comment on these information collection and record keeping requirements, please mail copies directly to the following:

Centers for Medicare & Medicaid Services, Office of Strategic

Operations and Regulatory Affairs, Division of Regulations Development,

Attn.: William Parham, CMS-1403-FC, Room C5-14-03, 7500 Security

Boulevard, Baltimore, MD 21244-1850.

Office of Information and Regulatory Affairs, Office of Management and

Budget, Room 10235, New Executive Office Building, Washington, DC 20503, Attn: CMS Desk Officer, CMS-1403-FC, Fax (202) 395-6974.

XV. Response to Comments

Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.

XVI. Regulatory Impact Analysis

We have examined the impact of this rule as required by Executive

Order 12866 on regulatory planning and review (September 30, 1993, as further amended), the Regulatory Flexibility Act (RFA) (September 19, 1980 Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)).

Executive Order 12866, as amended, directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year).

As indicated in more detail below in this regulatory impact analysis, we estimate that the PFS provisions included in this final rule with comment period will redistribute more than $100 million in 1 year.

Therefore, we estimate that this rulemaking is ``economically significant'' as measured by the $100 million threshold, and hence also a major rule under the Congressional

Page 69918

Review Act. Accordingly, we have prepared a RIA that to the best of our ability presents the costs and benefits of the rulemaking.

The RFA requires agencies to analyze options for regulatory relief of small businesses and other small entities, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, we estimate that most hospitals and most other providers are small entities as that term is used in the RFA (including small businesses, nonprofit organizations, and small governmental jurisdictions). Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of

$7 million to $34.5 million in any 1 year (For further information, see the Small Business Administration's regulation at 70 FR 72577, December 6, 2005.) Individuals and States are not included in the definition of a small entity. The RFA requires that we analyze regulatory options for small businesses and other entities. We prepare a regulatory flexibility analysis unless we certify that a rule would not have a significant economic impact on a substantial number of small entities.

The analysis must include a justification concerning the reason action is being taken, the kinds and number of small entities the rule affects, and an explanation of any meaningful options that achieve the objectives with less significant adverse economic impact on the small entities.

For purposes of the RFA, physicians, NPPs, and suppliers including

IDTFs are considered small businesses if they generate revenues of $7 million or less based on SBA size standards. Approximately 95 percent of physicians are considered to be small entities. There are about 980,000 physicians, other practitioners, and medical suppliers that receive Medicare payment under the PFS.

For purposes of the RFA, approximately 85 percent of suppliers of durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) are considered small businesses according to the Small Business

Administration's (SBA) size standards. We estimate that approximately 66,000 entities bill Medicare for DMEPOS each year. Total annual estimated Medicare revenues for DMEPOS suppliers are approximately

$10.8 billion in 2007 for which $8.3 billion was for fee-for-service and $2.5 billion was for managed care. However the therapeutic shoe, oxygen and oxygen equipment, and low vision aids provisions in this rule do not have a significant economic impact on a substantial number of small entities. In the case of therapeutic shoes, the regulation is being updated to reflect the fact that fee schedules were implemented on January 1, 2005, in accordance with the requirements of MMA section 627. Since the fees themselves are not impacted by this change, suppliers are likewise not impacted by this change. In the case of oxygen and oxygen equipment, as explained in section S.9. below, it is difficult to estimate the impact of section 144(b) of the MIPPA on small entities and oxygen and oxygen equipment suppliers in general.

Nevertheless, we do believe that the net impact on small entities and other suppliers of oxygen and oxygen equipment will be positive rather than negative. This is based on the fact that this change allows suppliers to retain ownership of oxygen equipment in all cases when it is no longer needed by the beneficiary. Prior to this change, suppliers were required to relinquish ownership of oxygen equipment after 36 continuous rental months. While suppliers will be required to continue furnishing the equipment after the 36-month rental period for up to 2 additional years in some cases until the 5 year reasonable useful lifetime of the equipment ends, they will retain ownership of equipment when it is no longer needed and can furnish the equipment to other patients. Although suppliers will not be paid for non-routine maintenance or repair of oxygen equipment they own and furnish to

Medicare beneficiaries, the equipment itself is very dependable and requires very little maintenance and servicing, so this change should not significantly impact suppliers. As previously noted, approximately 78 percent of Medicare beneficiaries that need oxygen do not use the oxygen equipment for more than 36 months. The changes mandated by section 144(b) of the MIPPA will have no impact on suppliers or beneficiaries in these cases.

For purposes of the RFA, approximately 80 percent of clinical diagnostic laboratories are considered small businesses according to the Small Business Administration's size standards. These are posted on the following Web site: http://sba.gov/idc/groups/public/documents/ sba_homepage/serv_sstd_tablepdf.pdf. Ambulance providers and suppliers for purposes of the RFA are also considered to be small entities.

In addition, most ESRD facilities are considered small entities for purposes of the RFA, either based on nonprofit status or by having revenues of $7 million to $34.5 million or less in any year. We consider a substantial number of entities to be significantly affected if the final rule with comment period has an annual average impact on small entities of 3 to 5 percent or more. Based on our analysis of the 926 nonprofit ESRD facilities considered small entities in accordance with the above definitions, we estimate that the combined impact of the changes to payment for renal dialysis services included in this final rule with comment period for nonprofit facilities will have a 0.7 percent decrease in overall payments relative to current overall payments. The majority of ESRD facilities will experience impacts of less than 3 percent of total revenues. We note that although the overall effect of the wage index changes is budget neutral, there are increases and decreases based on the location of individual facilities.

The analysis and discussion provided in this section XVI.F. of this final rule with comment period complies with the RFA requirements.

For the e-prescribing provisions, physician practices and independent pharmacies are considered small entities.

Because we acknowledge that many of the affected entities are small entities, the analysis discussed throughout the preamble of this rule constitutes our final regulatory flexibility analysis for the remaining provisions and addresses comments received on these issues.

Section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside a metropolitan statistical area and has fewer than 100 beds. We have determined that this final rule with comment period will have minimal impact on small hospitals located in rural areas. Of the 196 hospital-based ESRD facilities located in rural areas, only 40 are affiliated with hospitals with fewer than 100 beds.

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2008, that threshold is approximately $130 million. This final rule with comment period will not mandate any requirements for State, local, or tribal governments. Medicare beneficiaries are considered to be part of the private

Page 69919

sector for this purpose. A discussion concerning the impact of this rule on beneficiaries is found later in this section.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. The e-prescribing portions of this rule present a potential Federalism implication. No State categorically bars e- prescribing, but the scope and substance of State laws varies widely among the States. In recent years, many States have more actively legislated in this area. Should a State law be contrary to the Part D e-prescribing standards, or should it restrict the ability to carry out the Medicare Part D e-prescribing program, the MMA provides for preemption of that State law at section 1860D-4(e)(5) of the Act.

Section 1860D-4(e)(5) provides:

Relation to State Laws. The standards promulgated under the subsection shall supersede any State law or regulation that--

(A) Is contrary to the standards or restricts the ability to carry out this part; and

(B) Pertains to the electronic transmission of medication history and of information on eligibility, benefits, and prescriptions with respect to covered Part D drugs under this part.

For the reasons given above, we have determined that States would not incur any direct costs as a result of this rule. However, as mandated by section 1860D-4(e) of the Act, and under Executive Order 13132, we are required to minimize the extent of preemption, consistent with achieving the objectives of the Federal statute, and to meet certain other conditions. We believe that, taken as a whole, this final rule with comment period would meet these requirements.

We have prepared the following analysis, which together with the information provided in the rest of this preamble, meets all assessment requirements. The analysis explains the rationale for and purposes of this final rule with comment period; details the costs and benefits of the rule; analyzes alternatives; and presents the measures we will use to minimize the burden on small entities. As indicated elsewhere in this rule, we are implementing a variety of changes to our regulations, payments, or payment policies to ensure that our payment systems reflect changes in medical practice and the relative value of services.

We provide information for each of the policy changes in the relevant sections of this final rule with comment period. We are unaware of any relevant Federal rules that duplicate, overlap, or conflict with this final rule with comment period. The relevant sections of this rule contain a description of significant alternatives if applicable.

A. RVU Impacts 1. Resource-Based Work and PE RVUs

Section 1848(c)(2)(B)(ii) of the Act requires that increases or decreases in RVUs may not cause the amount of expenditures for the year to differ by more than $20 million from what expenditures would have been in the absence of these changes. If this threshold is exceeded, we make adjustments to preserve BN.

Section 133(b) of the MIPPA requires an alternative application of the BN adjustment that resulted from the 5-Year Review of Work RVUs.

The 0.8806 percent BN adjustment that is currently being applied to the work RVUs will be removed from the work RVUs and applied to the physician CF (See the CY 2008 PFS final rule with comment period (72 FR 66389) for further discussion of the BN adjustment that resulted from the 5-Year Review of Work RVUs). See sections III.E. and VII. of this final rule with comment period for more information on the provisions of section 133(b) of the MIPPA. The effect of this change on selected procedures is shown in Table 50.

Table 47 shows the specialty-level impact of the work and PE RVU changes.

Our estimates of changes in Medicare revenues for PFS services compare payment rates for CY 2008 with payment rates for CY 2009 using

CY 2007 Medicare utilization for all years. To the extent that there are year-to-year changes in the volume and mix of services provided by physicians, the actual impact on total Medicare revenues will be different than those shown in Table 47. The payment impacts reflect averages for each specialty based on Medicare utilization. The payment impact for an individual physician would be different from the average, based on the mix of services the physician provides. The average change in total revenues would be less than the impact displayed here because physicians furnish services to both Medicare and non-Medicare patients and specialties may receive substantial Medicare revenues for services that are not paid under the PFS. For instance, independent laboratories receive approximately 80 percent of their Medicare revenues from clinical laboratory services that are not paid under the PFS.

Table 47 shows only the payment impact on PFS services. The following is an explanation of the information represented in Table 47.

Specialty: The physician specialty or type of practitioner/supplier.

Allowed charges: Allowed charges are the Medicare Fee

Schedule amounts for covered services and include coinsurance and deductibles (which are the financial responsibility of the beneficiary). These amounts have been summed across all services furnished by physicians, practitioners, or suppliers within a specialty to arrive at the total allowed charges for the specialty.

Impact of Work RVU Changes for any new or revised CY 2009

PFS services.

Impact of PE RVU changes. The impact is shown for both 2009 which is the third year of the 4-year transition using the new methodology and the fully implemented 2010 PE RVUs.

Combined impact of the work RVUs and PE RVUs for both 2009 and the fully implemented 2010 PE RVUs.

Table 47--Combined Total Allowed Charge Impact for Work and Practice Expense RVU Changes

Impact of Impact of PE RVU changes

Combined impact of PE work RVU -------------------------- and work changes * changes

-------------------------

Specialty

Allowed

2009 (PE

2010 (PE

2009 (PE

2010 (PE charges (mil)

trans. year

full

trans. year

full 2009

implement.)

(percent)

(percent) (percent)

(percent)

1 TOTAL........................

$81,669

0 2 ALLERGY/IMMUNOLOGY...........

184

2 3 ANESTHESIOLOGY...............

1,966

-1

Page 69920

4 CARDIAC SURGERY..............

400

0 5 CARDIOLOGY...................

7,775

-2

-3

-2

-4 6 COLON AND RECTAL SURGERY.....

136

1 7 CRITICAL CARE................

224

0 8 DERMATOLOGY..................

2,557

5 9 EMERGENCY MEDICINE...........

2,451

0 10 ENDOCRINOLOGY...............

385

0 11 FAMILY PRACTICE.............

5,354

1 12 GASTROENTEROLOGY............

1,883

3 13 GENERAL PRACTICE............

842

0 14 GENERAL SURGERY.............

2,408

1 15 GERIATRICS..................

175

1 16 HAND SURGERY................

-1

-2

-1

-2 17 HEMATOLOGY/ONCOLOGY.........

2,019

-1

-1 18 INFECTIOUS DISEASE..........

561

2 19 INTERNAL MEDICINE...........

10,662

0 20 INTERVENTIONAL RADIOLOGY....

228

-1

-2 21 NEPHROLOGY..................

1,840

-1

-2

-1

-2 22 NEUROLOGY...................

1,489

0 23 NEUROSURGERY................

620

-1

-2 24 NUCLEAR MEDICINE............

-1

-2

-1

-1 25 OBSTETRICS/GYNECOLOGY.......

654

-1 26 OPHTHALMOLOGY...............

5,026

0 27 ORTHOPEDIC SURGERY..........

3,454

-1 28 OTOLARYNGOLOGY..............

984

-1

-1 29 PATHOLOGY...................

1,007

0 30 PEDIATRICS..................

1 31 PHYSICAL MEDICINE...........

850

-1

-1 32 PLASTIC SURGERY.............

288

1 33 PSYCHIATRY..................

1,169

1 34 PULMONARY DISEASE...........

1,828

1 35 RADIATION ONCOLOGY..........

1,854

-1

-2

-1

-2 36 RADIOLOGY...................

5,554

1 37 RHEUMATOLOGY................

521

-1

-1 38 THORACIC SURGERY............

431

0 39 UROLOGY.....................

2,146

0 40 VASCULAR SURGERY............

685

0 41 AUDIOLOGIST.................

-10

-20

-9

-19 42 CHIROPRACTOR................

768

-1

-1 43 CLINICAL PSYCHOLOGIST.......

571

-2

-4

-2

-3 44 CLINICAL SOCIAL WORKER......

378

-2

-3

-1

-3 45 NURSE ANESTHETIST...........

846

0 46 NURSE PRACTITIONER..........

963

1 47 OPTOMETRY...................

867

0 48 ORAL/MAXILLOFACIAL SURGERY..

2 49 PHYSICAL/OCCUPATIONAL

1,772

THERAPY....................... 50 PHYSICIAN ASSISTANT.........

711

1 51 PODIATRY....................

1,727

2 52 DIAGNOSTIC TESTING FACILITY.

1,186

-2

-4

-2

-4 53 INDEPENDENT LABORATORY......

878

10 54 PORTABLE X-RAY SUPPLIER.....

* Components may not sum to total due to rounding. 2. Adjustments for Payments for Imaging Services

Section 1848(c)(2)(B)(iv)(II) of the Act as added by section 5102 of the Deficit Reduction Act of 2005 (Pub. L. 109-171) (DRA) exempts the estimated savings from the application of the OPPS-based payment limitation on PFS imaging services from the PFS BN requirement. We estimate that the combined impact of the current BN exemptions instituted by such section, the addition of 4 new codes and the removal of 2 codes from the list of services subject to the DRA OPPS cap (See section V. G. Additional Coding Issues), and the payment revisions to

OPPS cap amounts would result in no measurable changes in the specialty specific impacts of the DRA provisions. 3. Combined Impact

Table 48 shows the specialty-level impact of the work and PE RVU changes, the impact of the MIPPA provision to apply the BN adjustment to the CF, the MIPPA provision for a 1.1

Page 69921

percent increase to the CF, and the combined impact of all of these changes. Additionally, the impacts in this final rule with comment period rule reflect the use of the updated physician time data from the

AMA-RUC, that is, used in step 13 of the detailed description of the PE methodology described in section II.A.1.i. of this final rule with comment period.

As indicated in Table 48, our estimates of changes in Medicare revenues for PFS services compare payment rates for CY 2008 with payment rates for CY 2009 using CY 2007 Medicare utilization crosswalked to 2009 services. To the extent that there are year-to-year changes in the volume and mix of services furnished by physicians, the actual impact on total Medicare revenues will be different than those shown in Table 48. These payment impacts reflect averages for each specialty based on Medicare utilization. The payment impact for an individual physician would be different from the average, based on the mix of services the physician furnishes.

Table 48 shows only the payment impact on PFS services. The following is an explanation of the information represented in Table 48.

Specialty: The physician specialty or type of practitioner/supplier.

Allowed Charges: Allowed charges are the Medicare Fee

Schedule amounts for covered services and include coinsurances and deductibles (which are the financial responsibility of the beneficiary.) These amounts have been summed across all services furnished by physicians, practitioners, or suppliers within a specialty to arrive at the total allowed charges for the specialty.

Impact of the CY 2009 Work and PE RVU changes using the methodology finalized in the CY 2007 PFS final rule with comment period and the revised data sources discussed in this final rule with comment period.

Impact of section 133(b) of the MIPPA which applies the BN adjustment resulting from the 5-Year Review of work RVUs to the physician CF rather than to the work RVUs.

Impact of section 131(a)(1) of the MIPPA which provides for a 1.1 update to the Medicare PFS CF.

Combined impact of the finalized work and PE RVUs, section 133(b) of the MIPPA, and section 131(a)(1) of the MIPPA.

Table 48--Combined CY 2009 Total Allowed Charge Impact for Work RVU Changes, Practice Expense Changes, and MIPPA

Changes

Work and PE

MIPPA

MIPPA 131

Specialty

Allowed

RVU Changes 133(b) **

Update

Total ***

Charges (mil) * (percent) (percent)

(percent)

1 TOTAL....................................

$81,669

1 2 ALLERGY/IMMUNOLOGY.......................

184

-3

-1 3 ANESTHESIOLOGY...........................

1,966

-1

3 4 CARDIAC SURGERY..........................

400

2 5 CARDIOLOGY...............................

7,775

-2

-1

-2 6 COLON AND RECTAL SURGERY.................

136

2 7 CRITICAL CARE............................

224

3 8 DERMATOLOGY..............................

2,557

-2

1 9 EMERGENCY MEDICINE.......................

2,451

4 10 ENDOCRINOLOGY...........................

385

2 11 FAMILY PRACTICE.........................

5,354

2 12 GASTROENTEROLOGY........................

1,883

3 13 GENERAL PRACTICE........................

842

2 14 GENERAL SURGERY..........................

2,408

3 15 GERIATRICS..............................

175

3 16 HAND SURGERY............................

-1

-1 17 HEMATOLOGY/ONCOLOGY.....................

2,019

-1

-2

-1 18 INFECTIOUS DISEASE......................

561

4 19 INTERNAL MEDICINE.......................

10,662

2 20 INTERVENTIONAL RADIOLOGY................

228

-1

0 21 NEPHROLOGY..............................

1,840

-1

2 22 NEUROLOGY...............................

1,489

1 23 NEUROSURGERY............................

620

-1

0 24 NUCLEAR MEDICINE........................

-1

-2

-1 25 OBSTETRICS/GYNECOLOGY...................

654

0 26 OPHTHALMOLOGY...........................

5,026

0 27 ORTHOPEDIC SURGERY......................

3,454

0 28 OTOLARNGOLOGY...........................

984

-1

-1 29 PATHOLOGY...............................

1,007

1 30 PEDIATRICS..............................

2 31 PHYSICAL MEDICINE.......................

850

1 32 PLASTIC SURGERY.........................

288

1 33 PSYCHIATRY..............................

1,169

4 34 PULMONARY DISEASE.......................

1,828

3 35 RADIATION ONCOLOGY......................

1,854

-1

-3

-3 36 RADIOLOGY...............................

5,554

-1

0 37 RHEUMATOLOGY............................

521

-1

-1 38 THORACIC SURGERY........................

431

2 39 UROLOGY.................................

2,146

-1

0 40 VASCULAR SURGERY........................

685

-1

1 41 AUDIOLOGIST.............................

-9

-2

-10 42 CHIROPRACTOR............................

768

-1

2 43 CLINICAL PSYCHOLOGIST...................

571

-2

2 44 CLINICAL SOCIAL WORKER..................

378

-1

Page 69922

45 NURSE ANESTHETIST.......................

846

5 46 NURSE PRACTITIONER......................

963

3 47 OPTOMETRY...............................

867

-1

0 48 ORAL/MAXILLOFACIAL SURGERY..............

-1

1 49 PHYSICAL/OCCUPATIONAL THERAPY...........

1,772

3 50 PHYSICIAN ASSISTANT.....................

711

2 51 PODIATRY................................

1,727

-1

1 52 DIAGNOSTIC TESTING FACILITY.............

1,186

-2

-5

-6 53 INDEPENDENT LABORATORY..................

878

-4

2 54 PORTABLE X-RAY SUPPLIER.................

-4

-2

* PE changes are CY 2009 third year transition changes. For fully implemented CY 2010 PE changes, see Table 1.

** Prior to the application of the OPPS imaging caps under DRA 5102.

*** Components may not sum to total due to rounding.

We received comments from individuals and organizations concerning the impact of the proposed rule, which reflected the projected negative update. These commenters stated that the proposed cuts in payment for services, particularly those for interventional pain management, could have a devastating impact on their ability to provide services to

Medicare beneficiaries. The commenters also expressed concern that the current PE payment methodology does not accurately reflect the costs needed to provide their services.

As discussed in sections III. and VII. of this final rule with comment period, section 131(a) of the MIPPA provides that the update to the single CF for CY 2009 shall be 1.1 percent. Tables 47 and 48 reflect this change. As required by the statute, payment under the PFS is resource-based. In future rulemaking, we expect to include improvements to the resource-based PE methodology that will include more current specialty specific aggregate cost data obtained through physician specialty practice surveys.

Table 49 shows the estimated impact on total payments for selected high-volume procedures of all of the changes discussed previously. We selected these procedures because they are the most commonly furnished by a broad spectrum of physician specialties. There are separate columns that show the change in the facility rates and the nonfacility rates. For an explanation of facility and nonfacility PE refer to

Addendum A of this final rule with comment period.

Table 49--Impact of Final Rule With Comment Period and Estimated Physician Update on 2009 Payment for Selected Procedures

Facility

Non-facility

CPT/HCPCS

MOD

Description

Percent

Percent 2008

2009

change

2008

2009

change

11721.................................. ..... Debride nail, 6 or more.........

$27.42

$27.77

$39.61

$40.39

2 17000.................................. ..... Destruct premalg lesion.........

46.47

48.69

67.41

69.97

4 27130.................................. ..... Total hip arthroplasty.......... 1,336.09 1,359.71

NA 27244.................................. ..... Treat thigh fracture............ 1,077.10 1,144.39

NA 27447.................................. ..... Total knee arthroplasty......... 1,435.12 1,456.37

NA 33533.................................. ..... CABG, arterial, single.......... 1,854.84 1,892.05

NA 35301.................................. ..... Rechanneling of artery.......... 1,045.11 1,067.93

NA 43239.................................. ..... Upper GI endoscopy, biopsy......

156.92

165.55

329.07

323.16

-2 66821.................................. ..... After cataract laser surgery....

249.47

251.38

266.23

266.53

0 66984.................................. ..... Cataract surg w/iol, 1 stage....

626.15

638.74

NA 67210.................................. ..... Treatment of retinal lesion.....

545.79

561.56

567.88

580.67

2 71010.................................. ..... Chest x-ray.....................

25.52

24.16

-5 71010..................................

26 Chest x-ray.....................

8.76

9.02

8.76

9.02

3 77056.................................. ..... Mammogram, both breasts.........

104.74

107.48

3 77056..................................

26 Mammogram, both breasts.........

41.90

44.36

41.90

44.36

6 77057.................................. ..... Mammogram, screening............

82.65

81.15

-2 77057..................................

26 Mammogram, screening............

33.90

35.71

33.90

35.71

5 77427.................................. ..... Radiation tx management, x5.....

177.10

188.27

177.10

188.27

6 78465..................................

26 Heart image (3d), multiple......

74.27

78.99

74.27

78.99

6 88305..................................

26 Tissue exam by pathologist......

36.18

37.15

36.18

37.15

3 90801.................................. ..... Psy dx interview................

125.31

128.04

147.02

152.92

4 90862.................................. ..... Medication management...........

43.80

45.08

52.18

55.18

6 90935.................................. ..... Hemodialysis, one evaluation....

65.13

66.36

NA 92012.................................. ..... Eye exam established pat........

43.04

45.80

70.08

70.69

1 92014.................................. ..... Eye exam & treatment............

66.27

70.33

101.69

103.15

1 92980.................................. ..... Insert intracoronary stent......

806.30

847.93

NA 93000.................................. ..... Electrocardiogram, complete.....

23.23

20.92

-10

23.23

20.92

-10

Page 69923

93010.................................. ..... Electrocardiogram report........

8.38

9.02

8.38

9.02

8 93015.................................. ..... Cardiovascular stress test......

103.98

100.27

-4

103.98

100.27

-4 93307..................................

26 Echo exam of heart..............

47.23

49.77

47.23

49.77

5 93510..................................

26 Left heart catheterization......

241.09

248.86

241.09

248.86

3 98941.................................. ..... Chiropractic manipulation.......

28.57

30.30

33.14

33.90

2 99203.................................. ..... Office/outpatient visit, new....

65.51

68.17

91.03

91.97

1 99213.................................. ..... Office/outpatient visit, est....

41.90

44.72

59.80

61.31

3 99214.................................. ..... Office/outpatient visit, est....

65.51

69.25

89.89

92.33

3 99222.................................. ..... Initial hospital care...........

116.93

122.63

NA 99223.................................. ..... Initial hospital care...........

171.77

180.33

NA 99231.................................. ..... Subsequent hospital care........

35.42

37.15

NA 99232.................................. ..... Subsequent hospital care........

63.22

66.72

NA 99233.................................. ..... Subsequent hospital care........

90.65

95.58

NA 99236.................................. ..... Observ/hosp same date...........

200.34

207.38

NA 99239.................................. ..... Hospital discharge day..........

92.93

96.30

NA 99243.................................. ..... Office consultation.............

92.93

97.38

122.26

124.79

2 99244.................................. ..... Office consultation.............

145.49

154.00

179.01

184.30

3 99253.................................. ..... Inpatient consultation..........

108.55

114.69

NA 99254.................................. ..... Inpatient consultation..........

156.54

165.55

NA 99283.................................. ..... Emergency dept visit............

59.03

61.31

NA 99284.................................. ..... Emergency dept visit............

108.93

114.33

NA 99291.................................. ..... Critical care, first hour.......

204.15

212.07

250.99

253.91

1 99292.................................. ..... Critical care, addtl 30 min.....

102.45

106.04

111.98

114.69

2 99348.................................. ..... Home visit, est patient.........

76.17

79.35

4 99350.................................. ..... Home visit, est patient.........

155.78

160.86

G0008.................................. ..... Admin influenza virus vac.......

20.57

20.92

Table 50 illustrates, for selected commonly provided procedures, how the payment amounts are affected solely by the requirement in section 133(b) of the MIPPA that BN for the 5-Year Review of physician work be applied to the CF instead of through a separate work adjustor.

While section 133(b) of the MIPPA does not increase or decrease expenditures in the aggregate for physician services, it will have a differential effect on services depending on the proportion of the PFS payment that is accounted for by work, PE, and malpractice. Physician work accounts for--on average across all PFS services--52.5 percent of total work RVUs. As BN for the 5-Year Review is being moved from the physician work RVUs only to the total payment, any service that has a higher than average proportion of its total payment accounted for by physician work will see its total payment increase solely as a result of section 133(b) of the MIPPA. Conversely, any service where physician work accounts for a lower than average proportion of its total payment, section 133(b) of the MIPPA will result in a reduction in payment.

Thus, section 133(b) of the MIPPA results in a payment reduction of 5 percent to CPT code 78565, Heart Image, 3d, Multiple, for the global service and 6 percent for the TC only. Physician work is 11 percent of the total RVU for the global and 0 percent of the TC of this service.

These percentages are less than the 52.5 percent on average that is attributed to physician work and explains why payment for these services declines as a result of section 133(b) of the MIPPA.

Similarly, the nonfacility amount for CPT code 99213 (Office/outpatient visit, est) increases by 0.5 percent because its work RVUs are a slightly higher proportion of its total payment (54 percent) than the 52.5 percent average for all physician services while the facility amount increases even more because its work RVUs as a percent of total

RVUs (74 percent) are significantly higher than the proportion on average for all physician services. A hospital visit (CPT code 99223) and an emergency department visit (CPT code 99285) also show higher increases in payment (3 and 4 percent respectively) due to section 133(b) of the MIPPA because physician work RVUs also account for a higher proportion of the total RVUs (76 and 80 percent respectively) than the average for all physician services.

Table 50--CY 2009 Impact of Placing Budget Neutrality Adjustment on the Conversion Factor

Section 133(b) of the MIPPA

Physician

Facility or

work as a % 2009 BN on 2009 BN on

Percent

CPT/HCPCS

Mod

Description

nonfacility

of total

work RVU

change

RVUs

78465.............................. ............... Heart image (3d),

Nonfacility...........

$509.48

$485.46

-5 multiple. 78465.............................. TC............. Heart image (3d),

Nonfacility...........

432.18

406.47

-6 multiple. 99213.............................. ............... Office/outpatient

Nonfacility...........

60.98

61.26

0.5 visit, est. 99213.............................. ............... Office/outpatient

Facility..............

43.34

44.69

3 visit, est. 99223.............................. ............... Initial hospital care. Facility..............

174.43

180.33

Page 69924

99285.............................. ............... Emergency dept visit.. Facility..............

163.99

170.60

B. Telehealth

In section II.D. of this final rule with comment period, we are creating HCPCS codes specific to the telehealth delivery of follow-up inpatient consultations. The new HCPCS codes will be limited to the range of services included in the scope of deleted CPT codes previously approved for telehealth, with the descriptions modified to limit the use of such services for telehealth. Utilization of these codes will allow us to provide payment for follow-up inpatient telehealth consultations, as well as enable us to monitor whether the codes are used appropriately.

The total annual Medicare payment amount for telehealth services

(including the originating site facility fee) is approximately $2 million. Previous additions to the list of Medicare telehealth services have not resulted in a significant increase in Medicare program expenditures. While we believe that the addition of follow-up inpatient telehealth consultation services to the approved telehealth service list will enable more beneficiaries access to these services, we do not anticipate that this change will have a significant budgetary impact on the Medicare program.

C. Payment for Covered Outpatient Drugs and Biologicals 1. ASP Issues

The changes discussed in section II.F.1. of this final rule with comment period with respect to payment for covered outpatient drugs and biologicals, are estimated to have no impact on Medicare expenditures. 2. CAP Issues

In the CY 2009 PFS proposed rule, we proposed minor refinements for the CAP, specifically the annual CAP payment amount update mechanism, the definition of a CAP physician, easing the restriction on the transportation of CAP drugs between practice locations, and the dispute resolution process. After the publication of the CY 2009 PFS proposed rule, further CAP implementation for 2009 was postponed. At this time, we are seeking feedback about the CAP from current and former CAP physicians, potential vendors, and other interested parties. We will assess the information and consider implementing changes to the CAP before proceeding with another bid solicitation.

Our proposed refinements to the CAP are not being finalized in this rule. Therefore, there is no potential impact associated with CAP provisions in the CY 2009 PFS rule.

D. Application of the HPSA Bonus Payment

As discussed in section II.G. of this final rule with comment period, there are no program cost savings or increased expenditures associated with this change; however, we expect that the regulation will increase the number of physicians who receive the bonus automatically, while decreasing the number of physicians required to use a modifier in order to receive the payment. It will also provide assurance to physicians and eligible recipients, for example health care facilities that bill under the CAH II method in qualified areas, that they will receive the HPSA bonus payment throughout the calendar year.

F. Provisions Related to Payment for Renal Dialysis Services Furnished by End-Stage Renal Disease (ESRD) Facilities

The ESRD-related provisions are discussed in section II.H. of this final rule with comment period. To understand the impact of the changes affecting payments to different categories of ESRD facilities, it is necessary to compare estimated payments under the current year (CY 2008 payments) to estimated payments under the revisions to the composite rate payment system (CY 2009 payments) as discussed in section II.H. of this final rule with comment period. To estimate the impact among various classes of ESRD facilities, it is imperative that the estimates of current payments and payments contain similar inputs. Therefore, we simulated payments only for those ESRD facilities that we are able to calculate both current 2008 payments and 2009 payments.

ESRD providers were grouped into the categories based on characteristics provided in the Online Survey and Certification and

Reporting (OSCAR) file and the most recent cost report data from the

Healthcare Cost Report Information System (HCRIS). We also used the

June 2008 update of CY 2007 National Claims History file as a basis for

Medicare dialysis treatments and separately billable drugs and biologicals. Due to data limitations, we are unable to estimate current and proposed payments for 96 of the 4954 ESRD facilities that bill for

ESRD dialysis treatments.

Table 51 shows the impact of this year's changes to CY 2009 payments to hospital-based and independent ESRD facilities. The first column of Table 51 identifies the type of ESRD provider, the second column indicates the number of ESRD facilities for each type, and the third column indicates the number of dialysis treatments.

The fourth column shows the effect of all changes to the ESRD wage index for CY 2009 as it affects the composite rate payments to ESRD facilities. The fourth column compares aggregate ESRD wage adjusted composite rate payments in the fourth year of the transition (CY 2009) to aggregate ESRD wage adjusted composite rate payments in the third year of the transition (CY 2008). In the fourth year of the transition

(CY 2009), ESRD facilities receive 100 percent of the CBSA wage adjusted composite rate and 0 percent of the MSA wage adjusted composite rate. In the third year of the transition, ESRD facilities receive 75 percent of the CBSA wage adjusted composite rate and 25 percent of the MSA wage adjusted composite rate. The overall effect to all ESRD providers in aggregate is zero because the CY 2009 ESRD wage index has been multiplied by a BN adjustment factor to comply with the statutory requirement that any wage index revisions be done in a manner that results in the same aggregate amount of expenditures as would have been made without any changes in the wage index. The impacts are similar to those shown in the proposed rule. (See the CY 2009 PFS proposed rule (73 FR 38599) for a

Continued on page 69925

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

]

pp. 69925-69974

Medicare Program; Payment Policies Under the Physician Fee

Schedule and Other Revisions to Part B for CY 2009; E-Prescribing

Exemption for Computer-Generated Facsimile Transmissions; and Payment for Certain Durable Medical Equipment, Prosthetics, Orthotics, and[Page 69925]

Continued from page 69924

Page 69925

breakout of the effects associated with the change in the wage index floor.)

The fifth column shows the effect of the MIPPA provisions on hospital-based and independent ESRD facilities. Section 153(a) of the

MIPPA updated section 1881(b)(12)(G) of the Act and revised payments to

ESRD facilities. The revisions that are effective January 1, 2009 include an update of 1 percent to the composite rate component of the payment system and the establishment of a site neutral composite rate to hospital-based and independent dialysis facilities.

The sixth column shows the overall effect of the changes in the composite rate payments to ESRD providers excluding the drug add-on.

This column shows the percent change between CY 2009 and CY 2008 composite rate payments to ESRD facilities. The sixth column combines the effects of changes in the wage index (column 4) with the effect of the MIPPA provisions (column 5). This column does not include the drug add-on to the composite rate.

The seventh column shows the overall effect of the changes in composite rate payments to ESRD providers including the drug add-on.

The overall effect is measured as the difference between the CY 2009 payment with all changes as proposed in this rule and current CY 2008 payment. This payment amount is computed by multiplying the wage adjusted composite rate with the drug add-on for each provider times the number of dialysis treatments from the CY 2007 claims. The CY 2009 payment is the transition year 4 wage-adjusted composite rate for each provider (with the 15.2 percent drug add-on) times dialysis treatments from CY 2007 claims. The CY 2008 current payment is the transition year 3 wage-adjusted composite rate for each provider (with the current 15.2 percent drug add-on) times dialysis treatments from CY 2007 claims.

The overall impact to ESRD providers in aggregate is 0.4 percent.

Most ESRD facilities will see an increase in payments as a result of the MIPPA provisions. However, the site neutral composite rate results in a 2.1 percent decrease in payments to hospital-based ESRD facilities. Since many hospital-based ESRD facilities are nonprofit, there is a 0.7 percent decrease in payments to all nonprofit ESRD facilities.

While the MIPPA provision includes a 1 percent increase to the ESRD composite rate, this 1 percent increase does not apply to the drug add- on to the composite rate. For this reason, the impact of all changes in this final rule is a 0.4 percent increase for all ESRD providers.

Overall, payments to independent ESRD facilities will increase by 0.7 percent and payments to hospital-based ESRD facilities will decrease 2.1 percent.

Table 51--Impact of CY 2009 Changes in Payments to Hospital-Based and Independent ESRD Facilities

Percent change in composite rate payments to ESRD facilities (both program and beneficiaries)

Number of

Overall

Overall dialysis

Effect of

effect

Number of treatments changes in the MIPPA

without

including facilities

(in

wage index provisions drug add-on drug add-on millions)

\1\

only \2\

\3\

\4\

All Providers:....................

4,858

36.4

0.0

0.7

0.4

Independent.......................

4,303

32.8

0.0

1.0

0.7

Hospital Based....................

555

3.7

0.2

-2.1

-1.9

-2.1

By Facility Size:

Less than 5000 treatments.....

1,732

5.0

-0.1

0.6

0.5

0.2 5000 to 9999 treatments.......

1,915

13.9

0.0

0.8

0.5

Greater than 9999 treatments..

1,211

17.6

0.0

0.6

0.4

Type of Ownership:

Profit........................

3,932

29.8

0.0

1.0

0.9

0.7

Nonprofit.....................

926

6.6

0.2

-0.7

-0.5

-0.7

By Geographic Location:

Rural.........................

1,320

7.6

-0.5

0.6

0.1

-0.1

Urban.........................

3,538

28.8

0.1

0.7

0.8

0.5

By Region:

New England...................

154

1.2

0.5

1.8

1.5

Middle Atlantic...............

566

4.6

0.1

0.2

0.3

0.0

East North Central............

768

5.8

-1.0

0.6

-0.4

-0.7

West North Central............

372

2.0

0.0

0.3

0.0

South Atlantic................

1104

8.3

-0.1

0.8

0.5

East South Central............

379

2.7

-1.0

0.9

0.0

-0.3

West South Central............

667

5.2

-0.5

0.9

0.3

0.1

Mountain......................

259

1.6

0.0

0.7

0.5

Pacific.......................

555

4.6

2.2

0.8

3.0

2.7

Puerto Rico & Virgin Islands..

0.4

-4.6

0.8

-3.8

-4.1

\1\ This column shows the overall effect of wage index changes on ESRD providers. Composite rate payments computed using the current wage index are compared to composite rate payments using the CY 2009 wage index changes. This column does not include the drug add-on to the composite rate.

\2\ This column shows the effect of the MIPPA provisions which include a 1 percent increase to composite rate and elimination of separate composite rate for hospital-based ESRD providers. These provisions are effective

January 1, 2009. This column does not include the drug add-on to the composite rate.

\3\ This column shows the percent change between CY 2009 and CY 2008 composite rate payments to ESRD facilities.

This column does not include the drug add-on to the composite rate.

\4\ This column shows the percent change between CY 2009 and CY 2008 composite rate payments to ESRD facilities.

The CY 2009 payments include the CY 2009 wage adjusted composite rate, and the 15.2 percent drug add-on times treatments. The CY 2008 payments to ESRD facilities includes the CY 2008 wage adjusted composite rate and the 15.5 percent drug add-on times treatments.

Page 69926

G. IDTF Issues

We believe that the provisions regarding IDTFs as discussed in

Section II.I. of this final rule with comment period will have minimal budgetary impact. We believe that the IDTF enrollment provisions contained in this rule are necessary and will help ensure that beneficiaries receive quality care by making certain that those entities providing mobile diagnostic testing services meet established performance standards and are enrolled in the Medicare program as

IDTFs. We maintain that most of these mobile units providing diagnostic testing services are already enrolled as IDTFs as required in Sec. 410.33(g), however we have no way of determining how many of these units are providing mobile diagnostic testing services, yet are not enrolled. We do not believe that beneficiary access to IDTF services will be affected by these requiring mobile units providing diagnostic testing services to enroll in the Medicare program.

H. Physician and Nonphysician Practitioner Enrollment Issues

We believe that the provisions regarding physicians, NPPs, and physician and NPP organizations as discussed in section II.J. of this final rule with comment period will have minimal budgetary impact. The provisions of this final rule supplement, but do not replace or nullify, existing regulations concerning the issuance of physician and

NPP billing privileges, and payment for Medicare covered items or services to eligible physicians and NPPs. We have already increased our efforts to seek more uniformity in the enrollment process. However, our experience clearly shows that the best means for preventing payment errors and, in worst cases, abuse by providers and suppliers, is to discourage and prevent their entry into the Medicare program. While some individuals and organizations may perceive our requirements as a barrier to their access to serving Medicare beneficiaries, we do not believe that bona fide physicians, NPP, or physician or NPP organizations will experience any difficulty in obtaining or maintaining Medicare billing privileges.

We expect this final rule with comment period to ensure that the

Medicare program has adequate information on those who seek to bill the program for items or services. The primary goal of this provision of the final rule with comment period, through standard enrollment requirements is to allow us to collect and maintain (keep current) a unique and equal data set on all current and future physicians, NPPs, and physician and NPP organizations that are billing or will bill the

Medicare program for items or services furnished to Medicare beneficiaries. By achieving this goal, we will be better positioned to protect the Medicare Trust Funds and the Medicare beneficiaries.

This rule will also allow us to develop, implement, and enforce national enrollment procedures to be administered uniformly by all

Medicare contractors. Further, we believe that the enrollment provisions contained in this rule are necessary to ensure that beneficiaries receive quality care by making certain that the physicians, NPPs, and physician or NPP organizations providing care meet established standards and are enrolled in the Medicare program.

As a result of currently not having quantifiable data, we cannot effectively derive an estimate of the monetary impacts of these provisions. Accordingly, we sought public comment so that the public may provide any data available that provides a calculable impact or any alternative to the proposed provision. However, no further data was presented by the public in order to provide a calculable impact. We adopted a modified enrollment policy after considering the alternatives that were suggested through the public comment period of the regulatory process which established the effective date of billing privileges for newly enrolling physicians, NPPs, and physician and NPP organizations.

I. Amendment to the Exemption for Computer-Generated Facsimile

Transmissions From the NCPDP SCRIPT Standard for Transmitting

Prescription and Certain Prescription-Related Information for Part D-

Covered Drugs Prescribed to Part D Eligible Individuals

The amendment to the exemption for computer-generated facsimiles from the NCPDP SCRIPT Standard under the Medicare Part D e-prescribing provisions is discussed in section II.K. of this rule. E-prescribing

Part D covered drugs to Part D eligible individuals is voluntary for providers and dispensers. The MMA only requires that if prescribers and dispensers choose to e-prescribe, that they use the standards adopted by the Secretary for those specific e-prescribing transactions. The amendment to the exemption for computer-generated faxing from the NCPDP

SCRIPT standard only affects pharmacies that already conduct e- prescribing using products that generate facsimiles.

This amendment of the exemption for computer-generated facsimiles to include prescription refill requests sent from dispensers to providers who do not possess the capability to conduct electronic refill request transactions using the NCPDP SCRIPT standard will not affect non-NCPDP SCRIPT enabled prescribers. Prescribers that currently e-prescribe using NCPDP SCRIPT would continue to receive refill requests electronically. Prescribers that currently e-prescribe with computer-generated faxes using a system that can utilize the NCPDP

SCRIPT standard will simply turn that function on, and receive refill request transactions using the NCPDP SCRIPT standard in place of the computer-generated facsimiles that they used to receive. Prescribers that do not have the capacity to use NCPDP SCRIPT standard would continue to receive computer-generated facsimiles. Moreover, the amendment would not impose costs on dispensers, as they would be permitted to continue using computer-generated facsimiles with partners that cannot conduct electronic refill request transactions using the

NCPDP SCRIPT standard. The amendment will have direct benefits for dispensers. One national drug store chain estimated that its stores generate 150,000 non-EDI prescription refill requests each day. If the computer-generated facsimile exemption were not modified, these dispensers would have to revert to paper/phone calls in instances in which a provider is not able to accept electronic refill requests utilizing the NCPDP SCRIPT standard. One chain pharmacy has relayed that moving forward with the scheduled elimination of the computer- generated faxing exception to the NCPDP SCRIPT standard in all instances other than transmission failures and similar communication problems of temporary or transient nature would result in approximately 105,000 initial paper facsimiles and 45,000 initial phone calls/oral scripts per day. They also consider a 2 percent facsimile failure rate that translates into phone calls, or approximately 2,100 additional phone calls per day. Ten percent of all phone calls require a second call back, or 4,710 call backs per day. Therefore, without further modification of computer-generated facsimiles exception, as of January 1, 2009 this national drug store chain would have to make a total of 51,810 additional phone calls for prescription refill requests per day.

They estimate the cost of reverting to paper facsimiles, including purchasing fax machines, labor, paper, printing, hardware, and service costs at over $12.5 million a year. They also estimate the cost per year of phone calls,

Page 69927

including an average of 4 minutes per call, labor, and telecommunication costs, at more than $78 million per year, for a total cost for faxes and phone calls of $88.8 million per year.\9\

\9\ CVS/Caremark Discussion Points on E-Fax Ruling Exceptions,

January 3, 2007.

Another national drug store chain offered a similar analysis. They estimated that a prescription refill request undertaken by telephone takes 1.43 minutes longer to complete than one initiated by computer- generated facsimile. Without further modification of the computer- generated facsimile exception, as of January 1, 2009 this national drug store chain would have to replace the more than 123 million computer- generated facsimile refill requests that are made each year with phone calls or paper faxes. They estimate that this would result in 9.2 lost hours of staff time per store per week, resulting in $88 million in additional costs, based on a blended payroll rate of pharmacists and staff. Extrapolating this cost across the entire pharmacy industry based on this commenter's market share, they estimated an impending pharmacy industry loss of at least $520 million unless the computer- generated facsimile exception is further modified.\10\

\10\ December 22, 2007 correspondence from Walgreen's to CMS re:

CMS-1385-FC, Final Rule with Comment Period: Amendment of the E-

Prescribing Exemption for Computer-Generated Facsimile

Transmissions.

According to industry reports in 2006 approximately 3.309 billion prescriptions \11\ were filled by retail dispensers, and according to

CMS data, in 2006, approximately 825,000,000 Part D claims

(prescription drug events) were finalized and accepted for payment,\12\ or approximately 25 percent of the total prescriptions filled that year. Thus, $130 million of the $520 million total loss estimated above would be attributable to Medicare Part D claims. We invite comments on these savings and loss assumptions estimates and assumptions.

\11\ http://www.statehealthfacts.org.

\12\ CMS, November 16, 2007 Proposed Rule, 72 FR 64913.

We also assume that expanding the computer-generated facsimile exception to allow for computer-generated faxing in instances in which the provider is incapable of receiving electronic refill request transactions using the NCPDP SCRIPT standard would result in improved patient satisfaction through timely prescription refill request authorizations from prescribers and maintenance of existing workflows at both the prescriber and dispenser ends.

Our decision to retain the exemption for computer-generated facsimiles in all instances other than temporary/transient transmission failures will have a positive impact on the industry overall, including small pharmacies and prescribers who are early adopters of e- prescribing and who may still depend on the use of computer-generated facsimiles to communicate. In the CY 2009 PFS proposed rule (73 FR 38601), we discussed the estimated losses that could result if we moved forward with the elimination of the computer-generated faxing exemption to the NCPDP SCRIPT standard in all instances other than temporary/ transient transmission failures. We stated that two national chain pharmacies said the proposed elimination of the computer-generated faxing exemption would result in a loss to each chain of approximately

$88 million in labor, lost productivity and telecommunications costs.

If this cost was extrapolated across the entire pharmacy industry, industry estimated an impending pharmacy industry loss of at least $520 million a year. As Medicare Part D claims account for approximately 25 percent of the total prescriptions filled annually, we estimated that

$130 million of that $520 loss would be attributable to Medicare Part D claims. We also considered other alternatives, including eliminating the exemption for computer-generated facsimiles in all instances, with an effective date of January 1, 2009, as detailed in the final rule with comment at 72 FR 66396; and eliminating the exemption for computer-generated facsimiles in all instances except for the prescription refill request transaction and in instances of temporary/ transient transmission failures. As we discussed previously in this final rule, we decided against imposing either of those alternatives in light of the advantage of the momentum that will be built by the e- prescribing incentive program under MIPPA, and affording the industry an additional 3 years from the effective date of this final rule to move toward true e-prescribing.

J. CORF Issues

The revisions to the CORF regulations discussed in section II.L. of this final rule with comment period updates the regulations for consistency with the PFS payment rules and make additional changes to the conditions of participation to reflect industry standards. These revisions will help to clarify payment and operational requirements for

CORF services and are expected to have minimal impact on Medicare expenditures.

K. Therapy Issues

The revisions to the therapy regulations discussed in section II.M. of this final rule with comment period make technical corrections and update the regulations and are expected to have minimal impact on

Medicare expenditures.

L. Physician Self-Referral Provisions

We anticipate that the provisions in section II.N. of this final rule with comment period concerning the anti-markup provisions in Sec. 414.50 will result in savings to the program by reducing overutilization and anti-competitive business arrangements. We cannot gauge with any certainty the extent of these savings to the Medicare program.

M1. Physician Quality Reporting Initiative (PQRI)

As discussed section II.O1. of this final rule with comment period, the final 2009 PQRI measures satisfy the requirement of section 1848(k)(2)(B)(iii) of the Act that the Secretary publish in the Federal

Secretary determines would be appropriate for eligible professionals to use to submit data to the Secretary in 2009. As discussed in section

II.O1. of this final rule with comment period, we are also offering options in 2009 for reporting some of the 2009 PQRI measures via submission of data to a clinical registry and options for reporting on measures groups rather than individual measures.

Although there may be some cost incurred for maintaining the measures used in the PQRI and their associated code sets, and for expanding an existing clinical data warehouse to accommodate registry- based data submission for the PQRI, we do not anticipate a significant cost impact on the Medicare program.

Participation in the PQRI by eligible professionals is voluntary and eligible professionals may have different processes for integrating the PQRI into their practices' work flows. Therefore, it is not possible to estimate with any degree of accuracy the impact of the PQRI on providers. One factor that influences the cost to eligible professionals is the time and effort associated with eligible professionals identifying applicable PQRI quality measures for which they can report the necessary information. We have no way to accurately quantify the burden because it would vary with each eligible professional by the number of measures applicable to the eligible professional, the eligible professional's familiarity

Page 69928

and understanding of the PQRI, and experience with participating in the

PQRI. In addition, eligible professionals may employ different methods for incorporating the use of quality data codes into the office work flows. Therefore, we will assign 3 hours as the amount of time needed for eligible professionals to review the PQRI quality measures, identify the applicable measures for which they can report the necessary information, and incorporate the use of quality data codes into the office work flows. Information from the Physician Voluntary

Reporting Program (PVRP) indicated an average labor cost of approximately $50 per hour. Thus, we estimate the cost for an eligible professional to review the PQRI quality measures, identify the applicable measures for which they can report the necessary information, and incorporate the use of quality data codes into the office work flows to be approximately $150 per eligible professional

($50 per hour x 3 hours).

For claims-based PQRI reporting, one factor in the cost to eligible professionals is the time and effort associated with gathering the required information, selecting the appropriate quality data codes, and including the appropriate quality data codes on the claims an eligible professional submits for payment. Information from the PVRP, estimates the cost to physicians to perform all the steps necessary to report 1 quality measure ranges from $0.21 in labor time to about $10.06 in labor time for more complicated cases and/or measures. For the median practice, the cost was about $0.90 in labor time per measure. Eligible professionals are generally required to report at least 3 measures to satisfactorily report PQRI quality measures data. Therefore, for purposes of this impact analysis we will assume that eligible professionals participating in the 2009 PQRI will report an average of 3 measures each.

The cost of implementing claims-based reporting of PQRI quality measures data also varies with the volume of claims on which quality data is reported. Preliminary results from the 2007 PQRI indicate that eligible professionals reported on 1 to 3,331 eligible instances per measure. For all 2007 PQRI measures, the median number of eligible instances reported on per measure was less than 60. On average, the median number of eligible instances reported on per measure was about 9. Therefore, for this analysis, we estimate that for each measure, an eligible professional reports the quality data on 9 cases.

Thus, we estimate the cost to each eligible professional associated with claims-based reporting of PQRI quality data codes to range from

$155.67 [($0.21 per measure x 3 measures x 9 cases per measure) + $150] to $421.62 [($10.06 per measure x 3 measure x 9 cases per measure) +

$150].

M2. Electronic Prescribing (E-Prescribing) Incentive Program

Section II.O2. of this final rule with comment period describes a new incentive program for eligible professionals who are considered successful electronic prescribers. To be considered a successful electronic prescriber, an eligible professional must report on the e- prescribing measure identified in section II.O2. of this final rule with comment period.

We anticipate that the cost impact of the E-Prescribing Incentive

Program on the Medicare program would be minimal since the program consists of only 1 quality measure.

Participation in the E-Prescribing Incentive Program by eligible professionals is voluntary and eligible professionals may have different processes for integrating the E-Prescribing Incentive Program into their practices' work flows. Therefore, it is not possible to estimate with any degree of accuracy the impact of the E-Prescribing

Incentive Program on eligible professionals. Similar to claims-based reporting for the PQRI, one factor in the cost to eligible professionals is the time and effort associated with eligible professionals determining whether the quality measure is applicable to them, gathering the required information, selecting the appropriate quality data codes, and including the appropriate quality data codes on the claims they submit for payment. Since the E-Prescribing Incentive

Program consists of only 1 quality measure, we will assign 1 hour as the amount of time needed for eligible professionals to review the e- prescribing measure and incorporate the use of quality data codes into the office work flows. At an average cost of approximately $50 per hour, we estimate the total cost to eligible professionals for reviewing the e-prescribing measure and incorporating the use of quality data codes into the office work flows to be approximately $50

($50 per hour x 1 hour).

Another factor in the cost to eligible professionals is the time and effort associated with gathering the required information, selecting the appropriate quality data codes, and including the appropriate quality data codes on the claims an eligible professional submits for payment. Information from the PVRP, estimates the cost to physicians to perform all the steps necessary to report 1 quality measure ranges from $0.21 in labor time to about $10.06 in labor time for more complicated cases and/or measures. For the median practice, the cost was about $0.90 in labor time per measure. Therefore, we estimate the costs to eligible professionals to perform all the steps necessary to report the e-prescribing measure on a claim to be approximately $0.90.

The cost for this requirement will also vary along with the volume of claims on which quality data is reported. Based on preliminary results from the 2007 PQRI described above and the fact that the measure's denominator consists of only billing codes for professional services, we estimate that each eligible professional reports the quality data on 60 cases for the e-prescribing measure.

Thus, we estimate the cost to each eligible professional associated with claims-based reporting of the e-prescribing measure to be

$104[($0.90 per measure x 1 measures x 60 cases per measure) + $50].

In addition, the e-prescribing measure requires eligible professionals to have and use a ``qualified'' e-prescribing system.

There are currently many commercial packages available for e- prescribing. One study indicated that a mid-range complete electronic medical record costs $2500 per license with an annual fee of $90 per license for quarterly updates of the drug database after setup costs while a standalone prescribing, messaging, and problem list system costs $1200 per physician per year after setup costs. Hardware costs and setup fees substantially add to the final cost of any software package. (Corley, S.T. (2003). ``Electronic prescribing: a review of costs and benefits.'' Topics in Health Information Management 24(1): 29-38.). The cost to an eligible professional of obtaining and utilizing an e-prescribing system varies not only by the commercial software package selected but also by the level at which the professional currently employs information technology in his or her practice and the level of training needed.

N. Educational Requirements for Nurse Practitioners and Clinical Nurse

Specialists

We anticipate that there are no program cost savings or increased expenditures associated with the changes discussed in section II.Q. of this final rule with comment period. However, we expect that the technical correction to the NP qualifications will

Page 69929

make the regulations comport with the agency's intent to require a master's degree in nursing as the minimum educational level for new NPs independently treating beneficiaries and directly billing the Medicare program. Also, the changes to the NP and CNS educational requirement to include the DNP doctoral degree will help to eliminate any concern or confusion for contractors and the nursing industry about whether APNs with doctoral degrees in nursing (but without a master's degree in nursing) meet our program qualifications.

O. Portable X-ray Personnel Qualifications

We anticipate that there are no program cost savings or increased expenditures associated with the changes discussed in section II.R. of this final rule with comment period; however, we expect that the revisions to the regulations will have a positive impact on patient care.

P. Prohibition Concerning Payment of Continuous Positive Airway

Pressure (CPAP) Devices

The provisions discussed in section II.S.2 of this final rule with comment period will reduce Medicare Trust Fund vulnerability to fraud and abuse and protect Medicare Beneficiaries from the burden of unnecessary sleep testing and unnecessary exposure to a medical device.

This prohibition will have no effect on providers as the majority of providers are not DMEPOS suppliers who would by supplying CPAP devices.

Only providers or other entities that perform both unattended out-of- facility sleep testing and supply CPAP machines to beneficiaries they have tested will be impacted which we believe would be very few, if any. For the reasons listed above, this final will have no impact on

DMEPOS suppliers because most suppliers only supply the CPAP machines; they do not evaluate patients, order sleep tests, nor do they interpret them.

Q. Beneficiary Signature Requirements for Nonemergency Ambulance

Services

We believe that our proposal in section II.S.3. of this final rule with comment period for allowing the ambulance provider or supplier to sign the claim on behalf of the beneficiary with respect to nonemergency transport services, provided that certain conditions are satisfied, will have no budgetary impact.

R. Revision to the ``Appeals of CMS or CMS Contractor Determinations

When a Provider or Supplier Fails to Meet the Requirements for Medicare

Billing Privileges'' Final Rule

We expect that the provision in section II.S.5. of this final rule with comment period will have an impact on an unknown number of persons and entities; however, we believe that this provision will impact only a small number of suppliers whose billing privileges are revoked due to

Federal debarment or exclusion, felony convictions, license suspensions or revocation, or because the supplier is no longer operating at a practice location provided to Medicare. We also believe that while this provision changes the effective date of revocation for certain suppliers that are no longer in compliance with Medicare enrollment requirements, this provision does not expand or change our revocation authority.

As a result of not having quantifiable data for the suppliers that meet the criteria for immediate revocation, we cannot effectively derive an estimate of the monetary impacts of this provision.

Accordingly, we sought public comment so that the public may provide any data available that provides a calculable impact or any alternative to the proposed provision. However, no further data was presented by the public in order to provide a calculable impact.

S. MIPPA Provisions 1. Section 101: Improvements to Coverage of Preventive Services a. Section 101(a) Coverage of Additional Preventive Services

As discussed earlier in the preamble, section 101(a) of the MIPPA provides the Secretary with the authority to add coverage of

``Additional Preventive Services'' and specifies the process and the criteria that are to be used in follow-up determinations regarding the coverage of such services under the Part B Program. As provided in the law, this new coverage allows payment for ``additional preventive services'' not otherwise described in Title XVIII of the Act, if the

Secretary determines through the national coverage determination (NCD) process that the new services meet statutory requirements for coverage.

We estimate that the new authority to review and add coverage of additional preventive services, if appropriate, will result in an increase in Medicare payments in the next couple of years to physician and other providers for such services. However, based on our experience in adding coverage of other preventive services (for example, the tobacco cessation benefit) we do not expect that the amount of the increase will be more than a modest amount. Since MIPPA refers to the evidence-based preventive services recommended by the USPSTF, costs would be aligned with the most effective screenings, and would avoid use of resources for those services that are not based on available evidence of effectiveness, thus reducing wasted resources. b. Section 101(b)--Revisions to Initial Preventive Physical Examination

(IPPE)

Section 101(b) of the MIPPA expands the eligibility period for beneficiaries using the initial preventive physical examination (IPPE) from 6 to 12 months, waives the Part B deductible, and makes several other changes to the benefit such as adding the measurement of the body mass index (BMI) and end-of-life planning to the list of required services. We estimate that the expansion of these Medicare Preventive services and the waiver of the Part B deductible requirement may increase the number of covered services that are performed in the next several years. As a result, we expect the amendment may result in a small but modest increase in payments to physicians and other qualified practitioners who provide these examinations and for any medically necessary follow-up (tests, counseling or treatment) that occur as a result of the initial preventive physical examination as beneficiaries increase their use of the benefit. The estimated financial impact is shown in Table 52.

Table 52--Medicare Cost Estimates for Section 101(b) of the MIPPA

In millions

MIPPA

CY 2009

CY 2010

CY 2011

CY 2012

CY 2013

Section 101(b)............................

Page 69930

2. Section 131: Physician Payment, Efficiency, and Quality

Improvements; and Section 132: Incentives for Electronic Prescribing

A discussion of the impact of these MIPPA provisons is addressed earlier in this section in conjunction with the other PQRI provisions being implemented (see section XV.M. of this final rule with comment period). 3. Section 131(c): Physician Resource Use Feedback Program

Section 131(c) of the MIPPA amends section 1848 of the Act by adding subsection (n), which requires the Secretary to establish and implement by January 1, 2009, a Physician Feedback Program using

Medicare claims data and other data to provide confidential feedback reports to physicians (and as determined appropriate by the Secretary, to groups of physicians) that measure the resources involved in furnishing care to Medicare beneficiaries. If determined appropriate by the Secretary, the Secretary may also include information on quality of care furnished to Medicare beneficiaries by the physician (or group of physicians) in the reports. We anticipate the impact of this section to be negligible for the work completed in the phased pilot physician feedback program to date. 4. Section 133(b): Expanding Access to Primary Care Services (BN

Adjustment)

The impact of this MIPPA provision is addressed in section VII. and previously in this section (XVI.A.) as part of the RVU impact discussion. 5. Section 134: Extension of Floor on Medicare Work Geographic

Adjustment Under the Medicare PFS

As discussed in section III.F. of this preamble, section 134 of the

MIPPA of 2008 extended the 1.000 work GPCI floor from July 1, 2008, through December 31, 2009. Additionally, the MIPPA sets a permanent 1.500 work GPCI floor in Alaska, beginning January 1, 2009. As a result of this MIPPA provision, 55 (out of 89) PFS localities will receive an increase in their work GPCI. Alaska receives the largest increase

(+47.49 percent), followed by Puerto Rico (+10.62 percent), South

Dakota (+6.16 percent), North Dakota (+5.60 percent) and the Missouri

``rest of state'' locality (+5.37 percent). The estimated impact for this provision is $400 million for CY 2009. 6. Section 136: Extension of Treatment of Certain

We do not have specific information on the number of independent laboratories that would be affected by section 136 of the MIPPA. We think that most, if not, all independent laboratories have some exposure to this billing practice. The estimated CY 2009 incurred benefit impact of the extension of this practice is $80 million. 7. Section 141: Extension of Exceptions Process for Medicare Therapy

Caps

Section 141 of the MIPPA extends the exceptions process for therapy caps from July 1, 2008, through December 31, 2009. The estimated impact of this provision for CY 2009 is $1.69 billion. 8. Section 143: Speech-Language Pathology Services

Amendments made by section 143 of the MIPPA provide the authority to enroll speech-language pathologists as suppliers of Medicare services and for speech-language pathologists to begin billing Medicare for outpatient speech language pathology services furnished in private practice beginning July 1, 2009. The enrollment of speech language pathologists to provide services in outpatient settings is expected to have a minimal impact on Medicare expenditures. 9. Section 144(b): Repeal of Transfer of Title for Oxygen Equipment

The revisions pertaining to oxygen and oxygen equipment in section

III.J. of this final rule with comment period reflect changes made by the MIPPA. Prior to the MIPPA, section 1834(a)(5)(F) of the Act limited monthly payments to suppliers furnishing oxygen equipment to 36 months of continuous use. At the end of this 36-month period, suppliers were required to transfer title to oxygen equipment rented on or after

January 1, 2006 to the beneficiary. Section 144(b) of the MIPPA repealed the transfer of title provision. In its place, section 144(b) establishes a 36-month rental cap and amends section 1834(a)(5)(F) of the Act by adding additional payment rules discussed previously in this preamble.

These changes may provide an economic benefit to suppliers because they will now retain ownership of oxygen equipment after 36 months of rental payments. If a beneficiary stops needing oxygen after the 36- month rental cap but before the end of the reasonable useful lifetime of the equipment (currently 5 years), the supplier will be able to retrieve the equipment and rent it to another Medicare beneficiary or other customer and receive additional rental payments for the remainder of the equipment's reasonable useful lifetime. It is difficult to estimate the impact of this change, but we believe the impact will be minimal and, therefore, do not believe it will be economically significant.

In addition, our regulations implementing MIPPA may provide a slight financial benefit to Medicare because we have determined that at this time it is not reasonable and necessary to make payments for non- routine maintenance and servicing (including repair) of supplier-owned oxygen equipment. We understand that oxygen equipment is very durable and should need few repairs in the first 5 years. Any costs suppliers may incur in repairs would be offset by the gains they achieve through retaining ownership of the equipment. Taken together, we expect these changes to have a minimal impact on Medicare expenditures. 10. Section 145: Clinical Laboratory Tests

Section 145 of the MIPPA reduces the Clinical Laboratory Fee

Schedule update by 0.5 percentage points for each year, CY 2009 through

CY 2013, and is estimated to result in an incurred benefit savings of

$40 million. 11. Section 146: Improved Access to Ambulance Services

Section 146 of the MIPPA makes certain changes to Medicare payment for ambulance services. Specifically, this section: Increases the payment rate under the Ambulance fee schedule by 2 percent or 3 percent for ground ambulance trips in urban and rural areas, respectively furnished during the period July 1, 2008 through December 31, 2009; and, for air ambulance services furnished during the period beginning on July 1, 2008, and ending on December 31, 2009, any area that was designated as a rural area for purposes of making payments under such section for air ambulance services furnished on December 31, 2006, shall be treated as a rural area for purposes of making payments for ambulance services furnished during such period. This section is estimated to increase Medicare expenditures by $20 million for CY 2009. 12. Section 149: Adding Certain Entities as Originating Sites for

Payment of Telehealth Services

This provision will increase access to telehealth services through the new authority for certain facilities to serve as originating sites and is expected to have a negligible budgetary impact on Medicare expenditures. 13. Section 153: Renal Dialysis Provisions

A discussion of the impact of section 153 of the MIPPA is addressed in

Page 69931

section XV.F. of this regulatory impact analysis in conjunction with the other ESRD provisions of this rule.

T. Competitive Acquisition for Certain Durable Medical Equipment,

Prosthetics, Orthotics, and Supplies (DMEPOS) 1. Low Vision Aids

We have determined that there will be no impact on Medicare beneficiaries, medical equipment industry, or the Medicare program.

This final rule with comment period clarifies a longstanding Medicare practice of not covering low vision aids. 2. Therapeutic Shoes Fee Schedule

The revisions to the therapeutic shoes regulations discussed in section XI.B. of this final rule are expected to have no impact on

Medicare expenditures. This final rule with comment period merely codifies in regulations our current practice of paying for therapeutic shoes on a fee schedule basis.

U. Alternatives Considered

This final rule with comment period contains a range of policies, including some provisions related to specific MMA provisions. The preamble provides descriptions of the statutory provisions that are addressed, identifies those policies when discretion has been exercised, responds to comments on our proposals, presents rationale for our decisions and, where relevant, alternatives that were considered. For a discussion of the sections that could impact small entities see the following sections: II.A.2. PE Proposals for CY 2009;

II.B. GPCIs: Locality Discussion; II.D. Medicare Telehealth Services;

II.E. Specific Coding Issues related to PFS; II.F. Part B Drug Payment;

II.G. Application of the HPSA Bonus Payment; II.H. Provisions Related to Payment for Renal Dialysis Services Furnished by ESRD Facilities;

II.I. IDTF Issues; II.J. Physician and NPP Enrollment Issues; II.K.

Amendment to the Exemption for Computer-Generated Facsimile

Transmission from the NCPDP SCRIPT Standard for Transmitting

Prescription and Certain Prescription-Related Information for Part D

Covered Drugs Prescribed for Part D Eligible Individuals; II.L. CORF and Rehabilitation Agency Issues; II.N. Physician Self-Referral and

Anti-Markup Issues; II.O1. Physician Quality Reporting Initiative and

O2. Electronic Prescribing (E-Prescribing) Incentive Program; II.Q.

Educational Requirements for Nurse Practitioners and Clinical Nurse

Specialists; II.R. Portable X-Ray Issue; II.S.2. Prohibition Concerning

Payment of Continuous Positive Airway Pressure (CPAP) Devices; II.S.3.

Beneficiary Signature for Nonemergency Ambulance Transport Services;

II.S 5. Revision to the ``Appeals of CMS or CMS contractor

Determinations When a Provider or Supplier Fails to Meet the

Requirements for Medicare Billing Privileges'' Final Rule; II.S.6.

Physician Resource Use Feedback Program; II.T. Electronic Prescribing

(E-Prescribing) Incentive Program; III.A. Section 101: Improvements to

Coverage of Preventive Services: III.I. Section 143: Speech-Language

Pathology Services; III.J. Section 144(b): Repeal of Transfer of Title for Oxygen Equipment; III.M. Section 149: Adding Certain Entities as

Originating Sites for Payment of Telehealth Services; IV. Potentially

Misvalued Codes Under PFS; V.E. Discussion of Codes and AMA RUC

Recommendations for Which There Was No AMA RUC recommendation or for

Which the Recommendation Was Not Accepted; V.G. Additional Coding

Issues; and V.H. Establishment of Interim PE RVUs for New and Revised

Physician's Current Procedural Terminology (CPT) Codes and New

Healthcare Common Procedure Coding System (HCPCS) Codes for 2009.

V. Impact on Beneficiaries

There are a number of changes made in this final rule with comment period that would have an effect on beneficiaries. In general, we believe these changes, including the refinements of the PQRI with its focus on measuring, submitting, and analyzing quality data, the MIPPA provisions related to the IPPE, and the changes with respect to telehealth services will have a positive impact and improve the quality and value of care provided to Medicare beneficiaries.

We do not believe that beneficiaries will experience drug access issues as a result of the changes with respect to Part B drugs and discontinuation of payment for preadministration services associated with IVIG.

As explained in more detail subsequently in this section, the regulatory provisions may affect beneficiary liability in some cases.

Most changes aggregate in beneficiary liability due to a particular provision would be a function of the coinsurance (20 percent if applicable for the particular provision after the beneficiary has met the deductible). Beneficiary liability would also be impacted by the effect of the aggregate cost (savings) of the provision on the standard calculation of the Medicare Part B premium rate (generally 25 percent of the provision's cost or savings). In 2009, total cost sharing

(coinsurance and deductible) per Part B enrollee associated with PFS services is estimated to be $468. In addition, the portion of the 2009 standard monthly Part B premium attributable to PFS services is estimated to be $40.10.

To illustrate this point, as shown in Table 47, the 2008 national payment amount in the nonfacility setting for CPT code 99203 (Office/ outpatient visit, new), is $91.03 which means that in 2008 a beneficiary is responsible for 20 percent of this amount, or $18. Based on this rule, the 2009 national payment amount in the nonfacility setting for CPT code 99203, as shown in Table 47, is $91.97 which means that, in 2009, the beneficiary coinsurance for this service would be

$18.39.

Policies discussed in this rule that do affect overall spending, such as the additions to the list of codes that are subject to the MPPR for diagnostic imaging, would similarly impact beneficiaries' coinsurance.

W. Accounting Statement

As required by OMB Circular A-4 (available at http:// www.whitehouse.gov/omb/circulars/a004/a-4.pdf), in Table 53, we have prepared an accounting statement showing the classification of the expenditures associated with this final rule with comment period. This estimate includes the incurred benefit impact associated with the estimated CY 2009 PFS update based on the 2008 Trustees Report baseline, as well as certain MIPPA provisions. All estimated impacts are classified as transfers.

Table 53--Accounting Statement: Classification of Estimated Expenditures

From CY 2008 to CY 2009

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Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
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Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
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Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
Find What You Need, Quickly

Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
Over 2 million registered users

Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.

Part II

You can sign up for a trial and make the most of our service including these benefits.

Why Sign-up to vLex?

Over 100 Countries

Thousands of Data Sources

Find What You Need, Quickly

Over 2 million registered users

You can sign up for a trial and make the most of our service including these benefits.

Why Sign-up to vLex?

Over 100 Countries

Thousands of Data Sources

Find What You Need, Quickly

Over 2 million registered users

You can sign up for a trial and make the most of our service including these benefits.

Why Sign-up to vLex?

Over 100 Countries

Thousands of Data Sources

Find What You Need, Quickly

Over 2 million registered users

You can sign up for a trial and make the most of our service including these benefits.

Why Sign-up to vLex?

Over 100 Countries

Thousands of Data Sources

Find What You Need, Quickly

Over 2 million registered users

You can sign up for a trial and make the most of our service including these benefits.

Why Sign-up to vLex?

Over 100 Countries

Thousands of Data Sources

Find What You Need, Quickly

Over 2 million registered users

Why Sign-up to vLex?

Over 100 Countries

Thousands of Data Sources

Find What You Need, Quickly

Over 2 million registered users

You can sign up for a trial and make the most of our service including these benefits.

Why Sign-up to vLex?

Over 100 Countries

Thousands of Data Sources

Find What You Need, Quickly

Over 2 million registered users