Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2016

 
CONTENT

Federal Register, Volume 80 Issue 135 (Wednesday, July 15, 2015)

Federal Register Volume 80, Number 135 (Wednesday, July 15, 2015)

Proposed Rules

Pages 41685-41966

From the Federal Register Online via the Government Publishing Office www.gpo.gov

FR Doc No: 2015-16875

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Vol. 80

Wednesday,

No. 135

July 15, 2015

Part III

Department of Health and Human Services

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Centers for Medicare & Medicaid Services

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42 CFR Parts 405, 410, 411, 414, et al.

Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2016; Proposed Rule

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 405, 410, 411, 414, 425, 495

CMS-1631-P

RIN 0938-AS40

Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2016

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

ACTION: Proposed rule.

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SUMMARY: This major proposed rule addresses 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, as well as changes in the statute.

DATES: Comment date: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on September 8, 2015.

ADDRESSES: In commenting, please refer to file code CMS-1631-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

You may submit comments in one of four ways (please choose only one of the ways listed):

1. Electronically. You may submit electronic comments on this regulation to www.regulations.gov. Follow the instructions for ``submitting a comment.''

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-1631-P, 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-1631-P, 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 before the close of the comment period to either of the following addresses:

a. For delivery in Washington, DC--Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201.

(Because access to the interior of the Hubert H. Humphrey 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.)

b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.

If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786-7195 in advance to schedule your arrival with one of our staff members.

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

FOR FURTHER INFORMATION CONTACT: Donta Henson, (410) 786-1947 for any physician payment issues not identified below.

Gail Addis, (410) 786-4522, for issues related to the refinement panel.

Chava Sheffield, (410) 786-2298, for issues related to practice expense methodology, impacts, conversion factors, target, and phase-in provisions.

Jessica Bruton, (410) 786-5991, for issues related to potentially misvalued code lists.

Geri Mondowney, (410) 786-4584, for issues related to geographic practice cost indices and malpractice RVUs.

Ken Marsalek, (410) 786-4502, for issues related to telehealth services.

Ann Marshall, (410) 786-3059, for issues related to advance care planning, and for primary care and care management services.

Michael Soracoe, (410) 786-6312, for issues related to the valuation and coding of the global surgical packages.

Roberta Epps, (410) 786-4503, for issues related to PAMA section 218(a) policy.

Regina Walker-Wren, (410) 786-9160, for issues related to the ``incident to'' proposals.

Lindsey Baldwin, (410) 786-1694, for issues related to valuation of moderate sedation and colonoscopy services and portable x-ray transportation fees.

Emily Yoder, (410) 786-1804, for issues related to valuation of radiation treatment services.

Amy Gruber, (410) 786-1542, for issues related to ambulance payment policy.

Corinne Axelrod, (410) 786-5620, for issues related to rural health clinics or federally qualified health centers and payment to grandfathered tribal FQHCs.

Simone Dennis, (410) 786-8409, for issues related to rural health clinics HCPCS reporting.

Edmund Kasaitis (410) 786-0477, for issues related to Part B drugs, biologicals, and biosimilars.

Alesia Hovatter, (410) 786-6861, for issues related to Physician Compare.

Christine Estella, (410) 786-0485, for issues related to the physician quality reporting system and the merit-based incentive payment system.

Alexandra Mugge (410) 786-4457, for issues related to EHR Incentive Program.

Sarah Arceo, (410) 786-2356) or Patrice Holtz, (410-786-5663) for issues related to EHR Incentive Program-CPC initiative and meaningful use aligned reporting.

Christiane LaBonte, (410) 786-7237, for issues related to comprehensive primary care initiative.

Rabia Khan, (410) 786-9328 or Terri Postma, (410) 786-4169, for issues related to Medicare Shared Savings Program.

Kimberly Spalding Bush, (410) 786-3232, or Sabrina Ahmed (410) 786-

7499, for issues related to value-based Payment Modifier and Physician Feedback Program.

Frederick Grabau, (410) 786-0206, for issues related to changes to opt-out regulations.

Lisa Ohrin Wilson (410) 786-8852, for issues related to physician self-referral updates.

SUPPLEMENTARY INFORMATION:

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

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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

I. Executive Summary and Background

  1. Executive Summary

  2. Background

    II. Provisions of the Proposed Rule for PFS

  3. Determination of Practice Expense (PE) Relative Value Units (RVUs)

  4. Determination of Malpractice Relative Value Units (RVUs)

  5. Potentially Misvalued Services Under the Physician Fee Schedule

  6. Refinement Panel

  7. Improving Payment Accuracy for Primary Care and Care Management Services

  8. Target for Relative Value Adjustments for Misvalued Services

  9. Phase-In of Significant RVU Reductions

  10. Changes for Computed Tomography (CT) Under the Protecting Access to Medicare Act of 2014 (PAMA)

    I. Valuation of Specific Codes

  11. Medicare Telehealth Services

  12. Incident to Proposals: Billing Physician as the Supervising Physician and Ancillary Personnel Requirements

    L. Portable X-Ray: Billing of the Transportation Fee

  13. Technical Correction: Waiver of Deductible for Anesthesia Services Furnished on the Same Date as a Planned Screening Colorectal Cancer Test

    III. Other Provisions of the Proposed Regulations

  14. Proposed Provisions Associated With the Ambulance Fee Schedule

  15. Chronic Care Management (CCM) Services for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)

  16. Healthcare Common Procedure Coding System (HCPCS) Coding for Rural Health Clinics (RHCs)

  17. Payment to Grandfathered Tribal FQHCs That Were Provider-

    Based Clinics on or Before April 7, 2000

  18. Part B Drugs--Biosimilars

  19. Productivity Adjustment for the Ambulance, Clinical Laboratory, and DMEPOS Fee Schedules

  20. Appropriate Use Criteria for Advanced Diagnostic Imaging Services

  21. Physician Compare Web site

    I. Physician Payment, Efficiency, and Quality Improvements--

    Physician Quality Reporting System

  22. Electronic Clinical Quality Measures (eCQM) and Certification Criteria and Electronic Health Record (EHR) Incentive Program--

    Comprehensive Primary Care (CPC) Initiative and Medicare Meaningful Use Aligned Reporting

  23. Potential Expansion of the Comprehensive Primary Care (CPC) Initiative

    L. Medicare Shared Savings Program

  24. Value-Based Payment Modifier and Physician Feedback Program

  25. Physician Self-Referral Updates

  26. Private Contracting/Opt-Out

    IV. Collection of Information Requirements

    V. Response to Comments

    VI. Regulatory Impact Analysis

    Regulations Text

    Acronyms

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

    AAA Abdominal aortic aneurysms

    ACO Accountable care organization

    AMA American Medical Association

    ASC Ambulatory surgical center

    ATA American Telehealth Association

    ATRA American Taxpayer Relief Act (Pub. L. 112-240)

    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)

    CAD Coronary artery disease

    CAH Critical access hospital

    CBSA Core-Based Statistical Area

    CCM Chronic care management

    CEHRT Certified EHR technology

    CF Conversion factor

    CG-CAHPS Clinician and Group Consumer Assessment of Healthcare Providers and Systems

    CLFS Clinical Laboratory Fee Schedule

    CNM Certified nurse-midwife

    CP Clinical psychologist

    CPC Comprehensive Primary Care

    CPEP Clinical Practice Expert Panel

    CPT Physicians Current Procedural Terminology (CPT codes, descriptions and other data only are copyright 2014 American Medical Association. All rights reserved.)

    CQM Clinical quality measure

    CSW Clinical social worker

    CT Computed tomography

    CY Calendar year

    DFAR Defense Federal Acquisition Regulations

    DHS Designated health services

    DM Diabetes mellitus

    DSMT Diabetes self-management training

    eCQM Electronic clinical quality measures

    EHR Electronic health record

    E/M Evaluation and management

    EP Eligible professional

    eRx Electronic prescribing

    ESRD End-stage renal disease

    FAR Federal Acquisition Regulations

    FFS Fee-for-service

    FQHC Federally qualified health center

    FR Federal Register

    GAF Geographic adjustment factor

    GAO Government Accountability Office

    GPCI Geographic practice cost index

    GPO Group purchasing organization

    GPRO Group practice reporting option

    GTR Genetic Testing Registry

    HCPCS Healthcare Common Procedure Coding System

    HHS Department of Health and Human Services

    HOPD Hospital outpatient department

    HPSA Health professional shortage area

    IDTF Independent diagnostic testing facility

    IPPS Inpatient Prospective Payment System

    IQR Inpatient Quality Reporting

    ISO Insurance service office

    IWPUT Intensity of work per unit of time

    LCD Local coverage determination

    MA Medicare Advantage

    MAC Medicare Administrative Contractor

    MAP Measure Applications Partnership

    MAPCP Multi-payer Advanced Primary Care Practice

    MAV Measure application validity process

    MCP Monthly capitation payment

    MedPAC Medicare Payment Advisory Commission

    MEI Medicare Economic Index

    MFP Multi-Factor Productivity

    MIPPA Medicare Improvements for Patients and Providers Act (Pub. L. 110-275)

    MMA Medicare Prescription Drug, Improvement and Modernization Act of 2003 (Pub. L. 108-173, enacted on December 8, 2003)

    MP Malpractice

    MPPR Multiple procedure payment reduction

    MRA Magnetic resonance angiography

    MRI Magnetic resonance imaging

    MSA Metropolitan Statistical Areas

    MSPB Medicare Spending per Beneficiary

    MSSP Medicare Shared Savings Program

    MU Meaningful use

    NCD National coverage determination

    NCQDIS National Coalition of Quality Diagnostic Imaging Services

    NP Nurse practitioner

    NPI National Provider Identifier

    NPP Nonphysician practitioner

    NQS National Quality Strategy

    OACT CMS's Office of the Actuary

    OBRA '89 Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239)

    OBRA '90 Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508)

    OES Occupational Employment Statistics

    OMB Office of Management and Budget

    OPPS Outpatient prospective payment system

    OT Occupational therapy

    PA Physician assistant

    PAMA Protecting Access to Medicare Act of 2014 (Pub. L. 113-93)

    PC Professional component

    PCIP Primary Care Incentive Payment

    PE Practice expense

    PE/HR Practice expense per hour

    PEAC Practice Expense Advisory Committee

    PECOS Provider Enrollment, Chain, and Ownership System

    PFS Physician Fee Schedule

    PLI Professional Liability Insurance

    PMA Premarket approval

    PQRS Physician Quality Reporting System

    PPIS Physician Practice Expense Information Survey

    PT Physical therapy

    PY Performance year

    QCDR Qualified clinical data registry

    QRUR Quality and Resources Use Report

    RBRVS Resource-based relative value scale

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    RFA Regulatory Flexibility Act

    RHC Rural health clinic

    RIA Regulatory impact analysis

    RUC American Medical Association/Specialty Society Relative (Value) Update Committee

    RUCA Rural Urban Commuting Area

    RVU Relative value unit

    SBA Small Business Administration

    SGR Sustainable growth rate

    SIM State Innovation Model

    SLP Speech-language pathology

    SMS Socioeconomic Monitoring System

    SNF Skilled nursing facility

    TAP Technical Advisory Panel

    TC Technical component

    TIN Tax identification number

    UAF Update adjustment factor

    UPIN Unique Physician Identification Number

    USPSTF United States Preventive Services Task Force

    VBP Value-based purchasing

    VM Value-Based Payment Modifier

    Addenda Available Only Through the Internet on the CMS Web Site

    The PFS Addenda along with other supporting documents and tables referenced in this proposed rule are available through the Internet on the CMS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. Click on the link on the left side of the screen titled, ``PFS Federal Regulations Notices'' for a chronological list of PFS Federal Register and other related documents. For the CY 2016 PFS proposed rule, refer to item CMS-1631-P. Readers who experience any problems accessing any of the Addenda or other documents referenced in this rule and posted on the CMS Web site identified above should contact Donta Henson at (410) 786-1947.

    CPT (Current Procedural Terminology) Copyright Notice

    Throughout this proposed rule, we use CPT codes and descriptions to refer to a variety of services. We note that CPT codes and descriptions are copyright 2015 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association (AMA). Applicable Federal Acquisition Regulations (FAR) and Defense Federal Acquisition Regulations (DFAR) apply.

    I. Executive Summary and Background

  27. Executive Summary

    1. Purpose

    This major proposed rule proposes to revise payment polices under the Medicare Physician Fee Schedule (PFS) and make other policy changes related to Medicare Part B payment. These proposed changes would be applicable to services furnished in CY 2016.

    2. Summary of the Major Provisions

    The Social Security Act (the Act) requires us to establish payments under the PFS based on national uniform relative value units (RVUs) that account for the relative resources used in furnishing a service. The Act requires that RVUs be established for three categories of resources: Work, practice expense (PE); and malpractice (MP) expense; and, that we establish by regulation each year's payment amounts for all physicians' services paid under the PFS, incorporating geographic adjustments to reflect the variations in the costs of furnishing services in different geographic areas. In this major proposed rule, we establish RVUs for CY 2016 for the PFS, 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, as well as changes in the statute. In addition, this proposed rule includes discussions and proposals regarding:

    Potentially Misvalued PFS Codes.

    Telehealth Services.

    Advance Care Planning Services.

    Establishing Values for New, Revised, and Misvalued Codes.

    Target for Relative Value Adjustments for Misvalued Services.

    Phase-in of Significant RVU Reductions.

    ``Incident to'' policy.

    Portable X-Ray Transportation Fee.

    Updating the Ambulance Fee Schedule regulations.

    Changes in Geographic Area Delineations for Ambulance Payment.

    Chronic Care Management Services for RHCs and FQHCs.

    HCPCS Coding for RHCs.

    Payment to Grandfathered Tribal FQHCs that were Provider-

    Based Clinics on or before April 7, 2000.

    Payment for Biosimilars under Medicare Part B.

    Physician Compare Web site.

    Physician Quality Reporting System.

    Medicare Shared Savings Program.

    Electronic Health Record (EHR) Incentive Program.

    Value-Based Payment Modifier and the Physician Feedback Program.

    3. Summary of Costs and Benefits

    The Act requires that annual adjustments to PFS RVUs may not cause annual estimated expenditures to differ by more than $20 million from what they would have been had the adjustments not been made. If adjustments to RVUs would cause expenditures to change by more than $20 million, we must make adjustments to preserve budget neutrality. These adjustments can affect the distribution of Medicare expenditures across specialties. In addition, several proposed changes would affect the specialty distribution of Medicare expenditures. When considering the combined impact of work, PE, and MP RVU changes, the projected payment impacts are small for most specialties; however, the impact would be larger for a few specialties.

    We have determined that this major proposed rule is economically significant. For a detailed discussion of the economic impacts, see section VII. of this proposed rule.

  28. Background

    Since January 1, 1992, Medicare has paid for physicians' services under section 1848 of the Act, ``Payment for Physicians' Services.'' The system relies on national relative values that are established for work, PE, and MP, which are adjusted for geographic cost variations. These values are multiplied by a conversion factor (CF) to convert the RVUs into payment rates. The concepts and methodology underlying the PFS were enacted as part of the Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239, enacted on December 19, 1989) (OBRA '89), and the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508, enacted on November 5, 1990) (OBRA '90). The final rule published on November 25, 1991 (56 FR 59502) set forth the first fee schedule used for payment for physicians' services.

    We note that throughout this major proposed rule, unless otherwise noted, the term ``practitioner'' is used to describe both physicians and nonphysician practitioners (NPPs) who are permitted to bill Medicare under the PFS for services furnished to Medicare beneficiaries.

    1. Development of the Relative Values

    a. Work RVUs

    The work RVUs established for the initial fee schedule, which was implemented on January 1, 1992, were developed with extensive input from the physician community. A research team at the Harvard School of Public Health developed the original work RVUs for most codes under a cooperative agreement with the Department of Health and Human Services (HHS). In constructing the code-specific vignettes used in determining the original physician work

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    RVUs, Harvard worked with panels of experts, both inside and outside the federal government, and obtained input from numerous physician specialty groups.

    As specified in section 1848(c)(1)(A) of the Act, the work component of physicians' services means the portion of the resources used in furnishing the service that reflects physician time and intensity. We establish work RVUs for new, revised and potentially misvalued codes based on our review of information that generally includes, but is not limited to, recommendations received from the American Medical Association/Specialty Society Relative Value Update Committee (RUC), the Health Care Professionals Advisory Committee (HCPAC), the Medicare Payment Advisory Commission (MedPAC), and other public commenters; medical literature and comparative databases; as well as a comparison of the work for other codes within the Medicare PFS, and consultation with other physicians and health care professionals within CMS and the federal government. We also assess the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters, and the rationale for their recommendations.

    b. Practice Expense RVUs

    Initially, only the work RVUs were resource-based, and the PE and MP RVUs were based on average allowable charges. Section 121 of the Social Security Act Amendments of 1994 (Pub. L. 103-432, 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 physicians' service beginning in 1998. We were required to consider general categories of expenses (such as office rent and wages of personnel, but excluding malpractice expenses) comprising PEs. The PE RVUs continue to represent the portion of these resources involved in furnishing PFS services.

    Originally, the resource-based method was to be used beginning in 1998, but section 4505(a) of the Balanced Budget Act of 1997 (Pub. L. 105-33, enacted on August 5, 1997) (BBA) delayed 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 the charge-based PE RVUs to the resource-based PE RVUs.

    We established the resource-based PE RVUs for each physicians' service in a final rule, published on November 2, 1998 (63 FR 58814), effective for services furnished in CY 1999. Based on the requirement to transition to a resource-based system for PE over a 4-year period, payment rates were not fully based upon resource-based PE RVUs until CY 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. (These data sources are described in greater detail in the CY 2012 final rule with comment period (76 FR 73033).)

    Separate PE RVUs are established for services furnished in facility settings, such as a hospital outpatient department (HOPD) or an ambulatory surgical center (ASC), and in nonfacility settings, such as a physician's office. The nonfacility RVUs reflect all of the direct and indirect PEs involved in furnishing a service described by a particular HCPCS code. The difference, if any, in these PE RVUs generally results in a higher payment in the nonfacility setting because in the facility settings some costs are borne by the facility. Medicare's payment to the facility (such as the outpatient prospective payment system (OPPS) payment to the HOPD) would reflect costs typically incurred by the facility. Thus, payment associated with those facility resources is not made under the PFS.

    Section 212 of the Balanced Budget Refinement Act of 1999 (Pub. L. 106-113, enacted on November 29, 1999) (BBRA) 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 the CY 2007 PFS final rule with comment period (71 FR 69624), we revised the methodology for calculating direct PE RVUs from the top-

    down to the bottom-up methodology beginning in CY 2007. We adopted a 4-

    year transition to the new PE RVUs. This transition was completed for CY 2010. In the CY 2010 PFS final rule with comment period, we updated the practice expense per hour (PE/HR) data that are used in the calculation of PE RVUs for most specialties (74 FR 61749). In CY 2010, we began a 4-year transition to the new PE RVUs using the updated PE/HR data, which was completed for CY 2013.

    c. Malpractice RVUs

    Section 4505(f) of the BBA amended section 1848(c) of the Act to require that we implement resource-based MP RVUs for services furnished on or after CY 2000. The resource-based MP RVUs were implemented in the PFS final rule with comment period published November 2, 1999 (64 FR 59380). The MP RVUs are based on commercial and physician-owned insurers' malpractice insurance premium data from all the states, the District of Columbia, and Puerto Rico. For more information on MP RVUs, see section II.C. of this proposed rule.

    d. Refinements to the RVUs

    Section 1848(c)(2)(B)(i) of the Act requires that we review RVUs no less often than every 5 years. Prior to CY 2013, we conducted periodic reviews of work RVUs and PE RVUs independently. We completed five-year reviews of work RVUs that were effective for calendar years 1997, 2002, 2007, and 2012.

    Although refinements to the direct PE inputs initially relied heavily on input from the RUC Practice Expense Advisory Committee (PEAC), the shifts to the bottom-up PE methodology in CY 2007 and to the use of the updated PE/HR data in CY 2010 have resulted in significant refinements to the PE RVUs in recent years.

    In the CY 2012 PFS final rule with comment period (76 FR 73057), we finalized a proposal to consolidate reviews of work and PE RVUs under section 1848(c)(2)(B) of the Act and reviews of potentially misvalued codes under section 1848(c)(2)(K) of the Act into one annual process.

    In addition to the five-year reviews, beginning for CY 2009, CMS, and the RUC have identified and reviewed a number of potentially misvalued codes on an annual basis based on various identification screens. This annual review of work and PE RVUs for potentially misvalued codes was supplemented by the amendments to section 1848 of the Act, as enacted by section 3134 of the Affordable Care Act, which requires the agency to periodically identify, review and adjust values for potentially misvalued codes.

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    e. Application of Budget Neutrality to Adjustments of RVUs

    As described in section VI.C. of this proposed rule, in accordance with section 1848(c)(2)(B)(ii)(II) of the Act, if revisions to the RVUs caused expenditures for the year to change by more than $20 million, we make adjustments to ensure that expenditures did not increase or decrease by more than $20 million.

    2. Calculation of Payments Based on RVUs

    To calculate the payment for each service, the components of the fee schedule (work, PE, and MP RVUs) are adjusted by geographic practice cost indices (GPCIs) to reflect the variations in the costs of furnishing the services. The GPCIs reflect the relative costs of work, PE, and MP in an area compared to the national average costs for each component. (See section II.D. of this proposed rule for more information about GPCIs.)

    RVUs are converted to dollar amounts through the application of a CF, which is calculated based on a statutory formula by CMS's 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 MP x GPCI MP) x CF.

    3. Separate Fee Schedule Methodology for Anesthesia Services

    Section 1848(b)(2)(B) of the Act specifies that the fee schedule amounts for anesthesia services are to be based on a uniform relative value guide, with appropriate adjustment of an anesthesia conversion factor, in a manner to assure that fee schedule amounts for anesthesia services are consistent with those for other services of comparable value. Therefore, there is a separate fee schedule methodology for anesthesia services. Specifically, we establish a separate conversion factor for anesthesia services and we utilize the uniform relative value guide, or base units, as well as time units, to calculate the fee schedule amounts for anesthesia services. Since anesthesia services are not valued using RVUs, a separate methodology for locality adjustments is also necessary. This involves an adjustment to the national anesthesia CF for each payment locality.

    4. Most Recent Changes to the Fee Schedule

    Section 220(d) of the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93, enacted on April 1, 2014) added a new subparagraph (O) to section 1848(c)(2) of the Act to establish an annual target for reductions in PFS expenditures resulting from adjustments to relative values of misvalued codes. If the estimated net reduction in expenditures for a year is equal to or greater than the target for that year, the provision specifies that reduced expenditures attributable to such adjustments shall be redistributed in a budget-

    neutral manner within the PFS. The provision also specifies that the amount by which such reduced expenditures exceed the target for a given year shall be treated as a reduction in expenditures for the subsequent year for purposes of determining whether the target for the subsequent year has been met. The provision also specifies that an amount equal to the difference between the target and the estimated net reduction, called the target recapture amount shall not be taken into account when applying the budget neutrality requirements specified in section 1848(c)(2)(B)(ii)(II) of the Act. The PAMA originally applied the target to CYs 2017 through 2020 and set the target amount to 0.5 percent of the estimated amount of expenditures under the PFS for each of those 4 years.

    More recently, section 202 of the Achieving a Better Life Experience Act of 2014 (ABLE) (Division B of Pub. L. 113-295, enacted December 19, 2014) accelerated the application of the target, amending section 1848(c)(2)(O) of the Act to specify that targets would apply for CYs 2016, 2017, and 2018 and set a 1 percent target for CY 2016 and 0.5 percent for CYs 2017 and 2018. The implementation of the target legislation is discussed in section II.F. of this proposed rule.

    Section 1848(c)(7) of the Act, as added by section 220(e) of the PAMA, specifies that for services that are not new or revised codes, if the total RVUs for a service for a year would otherwise be decreased by an estimated 20 percent or more as compared to the total RVUs for the previous year, the applicable adjustments in work, PE, and MP RVUs shall be phased-in over a 2-year period. Although section 220(e) of the PAMA required the phase-in of RVU reductions of 20 percent or more to begin for 2017, section 202 of the ABLE Act now requires the phase-in to begin in CY 2016. The implementation of the phase-in legislation is discussed in section II.G. of this proposed rule.

    Section 218(a) of the PAMA adds a new section 1834(p) to the statute. Section 1834(p) requires reductions in payment for the technical component (TC) (and the TC of the global fee) of the PFS service and in the hospital OPPS payment (5 percent in 2016, and 15 percent in 2017 and subsequent years) for computed tomography (CT) services (identified as of January 1, 2014 by HCPCS codes 70450-70498, 71250-71275, 72125-72133, 72191-72194, 73200-73206, 73700-73706, 74150-

    74178, 74261-74263, and 75571-75574, and succeeding codes) furnished using equipment that does not meet each of the attributes of the National Electrical Manufacturers Association (NEMA) Standard XR-29-

    2013, entitled ``Standard Attributes on CT Equipment Related to Dose Optimization and Management.'' The implementation of section 218(a) of the PAMA is discussed in section II.H. of this proposed rule.

    The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10, enacted on April 16, 2015) makes several changes to the statute, including but not limited to:

    (1) Repealing the sustainable growth rate (SGR) update methodology for physicians' services.

    (2) Revising the PFS update for 2015 and subsequent years.

    (3) Establishing a Merit-based Incentive Payment System (MIPS) under which eligible professionals (initially including physicians, physician assistants, nurse practitioners, clinical nurse specialists, and certified registered nurse anesthetists) receive annual payment increases or decreases based on their performance in a prior period. These and other MACRA provisions are discussions in various sections of this proposed rule. Please refer to the table of contents for the location of the various MACRA provision discussions.

    II. Provisions of the Proposed Rule for PFS

  29. Determination of Practice Expense (PE) Relative Value Units (RVUs)

    1. Overview

    Practice expense (PE) is the portion of the resources used in furnishing a 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. As required by section 1848(c)(2)(C)(ii) of the Act, we use a resource-based system for determining PE RVUs for each physicians' service. We develop PE RVUs by considering the direct and indirect practice resources involved in furnishing each service. Direct expense categories include clinical labor, medical supplies, and medical

    Page 41691

    equipment. Indirect expenses include administrative labor, office expense, and all other expenses. The sections that follow provide more detailed information about the methodology for translating the resources involved in furnishing each service into service-specific PE RVUs. We refer readers to the CY 2010 PFS final rule with comment period (74 FR 61743 through 61748) for a more detailed explanation of the PE methodology.

    2. Practice Expense Methodology

    a. Direct Practice Expense

    We determine the direct PE for a specific service by adding the costs of the direct resources (that is, the clinical staff, medical supplies, and medical equipment) typically involved with furnishing that service. The costs of the resources are calculated using the refined direct PE inputs assigned to each CPT code in our PE database, which are generally based on our review of recommendations received from the RUC and those provided in response to public comment periods. For a detailed explanation of the direct PE methodology, including examples, we refer readers to the Five-Year Review of Work Relative Value Units under the PFS and Proposed Changes to the Practice Expense Methodology proposed notice (71 FR 37242) and the CY 2007 PFS final rule with comment period (71 FR 69629).

    b. Indirect Practice Expense per Hour Data

    We use survey data on indirect PEs incurred per hour worked in developing the indirect portion of the PE RVUs. Prior to CY 2010, we primarily used the practice expense per hour (PE/HR) by specialty that was obtained from the AMA's Socioeconomic Monitoring Surveys (SMS). The AMA administered a new survey in CY 2007 and CY 2008, the Physician Practice Expense Information Survey (PPIS). The PPIS is a multispecialty, nationally representative, PE survey of both physicians and nonphysician practitioners (NPPs) paid under the PFS using a survey instrument and methods highly consistent with those used for the SMS and the supplemental surveys. The PPIS gathered information from 3,656 respondents across 51 physician specialty and health care professional groups. We believe the PPIS is the most comprehensive source of PE survey information available. We used the PPIS data to update the PE/HR data for the CY 2010 PFS for almost all of the Medicare-recognized specialties that participated in the survey.

    When we began using the PPIS data in CY 2010, we did not change the PE RVU methodology itself or the manner in which the PE/HR data are used in that methodology. We only updated the PE/HR data based on the new survey. Furthermore, as we explained in the CY 2010 PFS final rule with comment period (74 FR 61751), because of the magnitude of payment reductions for some specialties resulting from the use of the PPIS data, we transitioned its use over a 4-year period from the previous PE RVUs to the PE RVUs developed using the new PPIS data. As provided in the CY 2010 PFS final rule with comment period (74 FR 61751), the transition to the PPIS data was complete for CY 2013. Therefore, PE RVUs from CY 2013 forward are developed based entirely on the PPIS data, except as noted in this section.

    Section 1848(c)(2)(H)(i) of the Act requires us to use the medical oncology supplemental survey data submitted in 2003 for oncology drug administration services. Therefore, the PE/HR for medical oncology, hematology, and hematology/oncology reflects the continued use of these supplemental survey data.

    Supplemental survey data on independent labs from the College of American Pathologists were implemented for payments beginning in CY 2005. Supplemental survey data from the National Coalition of Quality Diagnostic Imaging Services (NCQDIS), representing independent diagnostic testing facilities (IDTFs), were blended with supplementary survey data from the American College of Radiology (ACR) and implemented for payments beginning in CY 2007. Neither IDTFs, nor independent labs, participated in the PPIS. Therefore, we continue to use the PE/HR that was developed from their supplemental survey data.

    Consistent with our past practice, the previous indirect PE/HR values from the supplemental surveys for these specialties were updated to CY 2006 using the MEI to put them on a comparable basis with the PPIS data.

    We also do not use the PPIS data for reproductive endocrinology and spine surgery since these specialties currently are not separately recognized by Medicare, nor do we have a method to blend the PPIS data with Medicare-recognized specialty data.

    Previously, we established PE/HR values for various specialties without SMS or supplemental survey data by crosswalking them to other similar specialties to estimate a proxy PE/HR. For specialties that were part of the PPIS for which we previously used a crosswalked PE/HR, we instead used the PPIS-based PE/HR. We continue previous crosswalks for specialties that did not participate in the PPIS. However, beginning in CY 2010 we changed the PE/HR crosswalk for portable x-ray suppliers from radiology to IDTF, a more appropriate crosswalk because these specialties are more similar to each other for work time.

    For registered dietician services, the resource-based PE RVUs have been calculated in accordance with the final policy that crosswalks the specialty to the ``All Physicians'' PE/HR data, as adopted in the CY 2010 PFS final rule with comment period (74 FR 61752) and discussed in more detail in the CY 2011 PFS final rule with comment period (75 FR 73183).

    For CY 2016, we have incorporated the available utilization data for interventional cardiology, which became a recognized Medicare specialty during 2014. We are proposing to use a proxy PE/HR value for interventional cardiology, as there are no PPIS data for this specialty, by crosswalking the PE/HR for from Cardiology, since the specialties furnish similar services in the Medicare claims data. The proposed change is reflected in the ``PE/HR'' file available on the CMS Web site under the supporting data files for the CY 2016 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.

    c. Allocation of PE to Services

    To establish PE RVUs for specific services, it is necessary to establish the direct and indirect PE associated with each service.

    (1) Direct Costs

    The relative relationship between the direct cost portions of the PE RVUs for any two services is determined by the relative relationship between the sum of the direct cost resources (that is, the clinical staff, medical supplies, and medical equipment) typically involved with furnishing each of the services. The costs of these resources are calculated from the refined direct PE inputs in our PE database. For example, if one service has a direct cost sum of $400 from our PE database and another service has a direct cost sum of $200, the direct portion of the PE RVUs of the first service would be twice as much as the direct portion of the PE RVUs for the second service.

    (2) Indirect Costs

    Section II.A.2.b. of this proposed rule describes the current data sources for specialty-specific indirect costs used in our PE calculations. We allocated the

    Page 41692

    indirect costs to the code level on the basis of the direct costs specifically associated with a code and the greater of either the clinical labor costs or the work RVUs. We also incorporated the survey data described earlier in the PE/HR discussion. The general approach to developing the indirect portion of the PE RVUs is as follows:

    For a given service, we use the direct portion of the PE RVUs calculated as previously described and the average percentage that direct costs represent of total costs (based on survey data) across the specialties that furnish the service to determine an initial indirect allocator. In other words, the initial indirect allocator is calculated so that the direct costs equal the average percentage of direct costs of those specialties furnishing the service. For example, if the direct portion of the PE RVUs for a given service is 2.00 and direct costs, on average, represented 25 percent of total costs for the specialties that furnished the service, the initial indirect allocator would be calculated so that it equals 75 percent of the total PE RVUs. Thus, in this example, the initial indirect allocator would equal 6.00, resulting in a total PE RVUs of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75 percent of 8.00).

    Next, we add the greater of the work RVUs or clinical labor portion of the direct portion of the PE RVUs to this initial indirect allocator. In our example, if this service had work RVUs of 4.00 and the clinical labor portion of the direct PE RVUs was 1.50, we would add 4.00 (since the 4.00 work RVUs are greater than the 1.50 clinical labor portion) to the initial indirect allocator of 6.00 to get an indirect allocator of 10.00. In the absence of any further use of the survey data, the relative relationship between the indirect cost portions of the PE RVUs for any two services would be determined by the relative relationship between these indirect cost allocators. For example, if one service had an indirect cost allocator of 10.00 and another service had an indirect cost allocator of 5.00, the indirect portion of the PE RVUs of the first service would be twice as great as the indirect portion of the PE RVUs for the second service.

    Next, we incorporate the specialty-specific indirect PE/HR data into the calculation. In our example, if, based on the survey data, the average indirect cost of the specialties furnishing the first service with an allocator of 10.00 was half of the average indirect cost of the specialties furnishing the second service with an indirect allocator of 5.00, the indirect portion of the PE RVUs of the first service would be equal to that of the second service.

    (4) Facility and Nonfacility Costs

    For procedures that can be furnished in a physician's office, as well as in a hospital or other facility setting, we establish two PE RVUs: facility and nonfacility. The methodology for calculating PE RVUs is the same for both the facility and nonfacility RVUs, but is applied independently to yield two separate PE RVUs. Because in calculating the PE RVUs for services furnished in a facility, we do not include resources that would generally not be provided by physicians when furnishing the service in a facility, the facility PE RVUs are generally lower than the nonfacility PE RVUs. Medicare makes a separate payment to the facility for its costs of furnishing a service.

    (5) 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). The PC and TC may be furnished independently or by different providers, or they may be furnished together as a ``global'' service. When services have separately billable PC and TC components, the payment for the global service equals the sum of the payment for the TC and PC. To achieve this we use a weighted average of the ratio of indirect to direct costs across all the specialties that furnish the global service, TCs, and PCs; that is, we apply the same weighted average indirect percentage factor to allocate indirect expenses to the global service, PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum to the global.)

    (6) PE RVU Methodology

    For a more detailed description of the PE RVU methodology, we refer readers to the CY 2010 PFS final rule with comment period (74 FR 61745 through 61746).

    (a) 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 PE/HR data calculated from the surveys.

    (b) 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. Apply a scaling adjustment to the direct inputs.

    Step 2: Calculate the aggregate pool of direct PE costs for the current year. Under our current methodology, we first multiply the current year's conversion factor by the product of the current year's PE RVUs and utilization for each service to arrive at the aggregate pool of total PE costs (Step 2a). We then calculate the average direct percentage of the current pool of PE RVUs (using a weighted average of the survey data for the specialties that furnish each service (Step 2b).) We then multiply the result of 2a by the result of 2b to arrive at the aggregate pool of direct PE costs for the current year. For CY 2016, we are proposing a technical improvement to step 2a of this calculation. In place of the step 2a calculation described above, we propose to set the aggregate pool of PE costs equal to the product of the ratio of the current aggregate PE RVUs to current aggregate work RVUs and the proposed aggregate work RVUs. Historically, in allowing the current PE RVUs to determine the size of the base PE pool in the PE methodology, we have assumed that the relationship of PE RVUs to work RVUs is constant from year to year. Since this is not ordinarily the case, by not considering the proposed aggregate work RVUs in determining the size of the base PE pool, we have introduced some minor instability from year to year in the relative shares of work, PE, and MP RVUs. While this proposed modification would result in greater stability in the relationship among the work and PE RVU components in the aggregate, we do not anticipate it will affect the distribution of PE RVUs across specialties. The PE RVUs in addendum B of this proposed rule with comment period reflect this proposed refinement to the PE methodology.

    Step 3: Calculate the aggregate pool of direct PE costs for use in ratesetting. This is the product of the aggregate direct costs for all services 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 scaling adjustment to ensure that the aggregate pool of direct PE costs calculated in Step 3 does not vary from the aggregate pool of direct PE costs for the current year. Apply the scaling factor to the direct costs for each service (as calculated in Step 1).

    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 CF. Note that the actual value of the CF used in this calculation does not influence the final direct cost PE RVUs, as long as the same CF is used in Step 2 and Step 5. Different CFs will result in different direct PE scaling factors, but

    Page 41693

    this has no effect on the final direct cost PE RVUs since changes in the CFs and changes in the associated direct scaling factors offset one another.

    (c) Create the Indirect Cost PE RVUs

    Create indirect allocators.

    Step 6: Based on the 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, the direct and indirect percentages for a given service do not vary by the PC, TC, and global service.

    Historically, we have used the specialties that furnish the service in the most recent full year of Medicare claims data (crosswalked to the current year set of codes) to determine which specialties furnish individual procedures. For example, for CY 2015 ratesetting, we used the mix of specialties that furnished the services in the CY 2013 claims data to determine the specialty mix assigned to each code. While we believe that there are clear advantages to using the most recent available data in making these determinations, we have also found that using a single year of data contributes to greater year-to-year instability in PE RVUs for individual codes and often creates extreme, annual fluctuations for low-volume services, as well as delayed fluctuations for some services described by new codes once claims data for those codes becomes available.

    We believe that using an average of the three most recent years of available data may increase stability of PE RVUs and mitigate code-

    level fluctuations for both the full range of PFS codes, and for new and low-volume codes in particular. Therefore, we are proposing to refine this step of the PE methodology to use an average of the 3 most recent years of available Medicare claims data to determine the specialty mix assigned to each code. The PE RVUs in Addendum B of the CMS Web site reflect this proposed refinement to the PE methodology.

    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 RVUs; the clinical PE RVUs; and the work RVUs. For most services the indirect allocator is: Indirect PE percentage * (direct PE RVUs/direct percentage) work RVUs.

    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 PE allocator is: Indirect percentage (direct PE RVUs/direct percentage) clinical labor PE RVUs work RVUs.

    If the clinical labor PE RVUs exceed the work RVUs (and the service is not a global service), then the indirect allocator is: Indirect PE percentage (direct PE RVUs/direct percentage) clinical labor PE RVUs.

    (Note: For global services, the indirect PE allocator is based on both the work RVUs and the clinical labor PE RVUs. We do this to recognize that, for the PC service, indirect PEs will be allocated using the work RVUs, and for the TC service, indirect PEs will be allocated using the direct PE RVUs and the clinical labor PE RVUs. 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 RVUs/direct percentage).

    The second part is either the work RVU, clinical labor PE RVU, or both depending on whether the service is a global service and whether the clinical PE RVUs exceed the work RVUs (as described earlier in this step).

    Apply a scaling adjustment to the indirect allocators.

    Step 9: Calculate the current aggregate pool of indirect PE RVUs by multiplying the result of step 2a (as calculated with the proposed change) by the average indirect PE percentage from the survey data.

    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.

    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.

    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 work time for the service, and the specialty's utilization for the service across all services furnished by the specialty.

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

    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 service, 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 service.)

    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 RVUs.

    (d) Calculate the Final PE RVUs

    Step 18: Add the direct PE RVUs from Step 6 to the indirect PE RVUs from Step 17 and apply the final PE budget neutrality (BN) adjustment. The final PE BN adjustment is calculated by comparing the results of Step 18 to the proposed aggregate work RVUs scaled by the ratio of current aggregate PE and work RVUs, consistent with the proposed changes in Steps 2 and 9. This final BN adjustment is required to redistribute RVUs from step 18 to all PE RVUs in the PFS, and because certain specialties are excluded from the PE RVU calculation for ratesetting purposes, but we note that all specialties are included for purposes of calculating the final BN adjustment. (See ``Specialties excluded from ratesetting calculation'' later in this section.)

    (e) Setup File Information

    Specialties excluded from ratesetting calculation: For the purposes of calculating the PE RVUs, we exclude certain specialties, such as certain nonphysician practitioners paid at a percentage of the PFS and low-volume specialties, from the calculation. These specialties are included for the purposes of calculating the BN adjustment. They are displayed in Table 1.

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    Table 1--Specialties Excluded from Ratesetting Calculation

    ------------------------------------------------------------------------

    Specialty code Specialty description

    ------------------------------------------------------------------------

    49..................... Ambulatory surgical center.

    50..................... Nurse practitioner.

    51..................... Medical supply company with certified

    orthotist.

    52..................... Medical supply company with certified

    prosthetist.

    53..................... Medical supply company with certified

    prosthetistdashorthotist.

    54..................... Medical supply company not included in 51, 52,

    or 53.

    55..................... Individual certified orthotist.

    56..................... Individual certified prosthetist.

    57..................... Individual certified

    prosthetistdashorthotist.

    58..................... Medical supply company with registered

    pharmacist.

    59..................... Ambulance service supplier, e.g., private

    ambulance companies, funeral homes, etc.

    60..................... Public health or welfare agencies.

    61..................... Voluntary health or charitable agencies.

    73..................... Mass immunization roster biller.

    74..................... Radiation therapy centers.

    87..................... All other suppliers (e.g., drug and department

    stores).

    88..................... Unknown supplier/provider specialty.

    89..................... Certified clinical nurse specialist.

    96..................... Optician.

    97..................... Physician assistant.

    A0..................... Hospital.

    A1..................... SNF.

    A2..................... Intermediate care nursing facility.

    A3..................... Nursing facility, other.

    A4..................... HHA.

    A5..................... Pharmacy.

    A6..................... Medical supply company with respiratory

    therapist.

    A7..................... Department store.

    B2..................... Pedorthic personnel.

    B3..................... Medical supply company with pedorthic

    personnel.

    ------------------------------------------------------------------------

    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 RVUs. For example, the professional service, CPT code 93010 (Electrocardiogram, routine ECG with at least 12 leads; interpretation and report only), is associated with the global service, CPT code 93000 (Electrocardiogram, routine ECG with at least 12 leads; with interpretation and report).

    Payment modifiers: Payment modifiers are accounted for in the creation of the file consistent with current payment policy as implemented in claims processing. 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. Similarly, for those services to which volume adjustments are made to account for the payment modifiers, time adjustments are applied as well. For time adjustments to surgical services, the intraoperative portion in the work time file is used; where it is not present, the intraoperative percentage from the payment files used by contractors to process Medicare claims is used instead. Where neither is available, we use the payment adjustment ratio to adjust the time accordingly. Table 2 details the manner in which the modifiers are applied.

    Table 2--Application of Payment Modifiers to Utilization Files

    ----------------------------------------------------------------------------------------------------------------

    Modifier Description Volume adjustment Time adjustment

    ----------------------------------------------------------------------------------------------------------------

    80,81,82............................. Assistant at Surgery... 16%.................... Intraoperative portion.

    AS................................... Assistant at Surgery-- 14% (85% * 16%)........ Intraoperative portion.

    Physician Assistant.

    50 or LT and RT...................... Bilateral Surgery...... 150%................... 150% of work time.

    51................................... Multiple Procedure..... 50%.................... Intraoperative portion.

    52................................... Reduced Services....... 50%.................... 50%.

    53................................... Discontinued Procedure. 50%.................... 50%.

    54................................... Intraoperative Care Preoperative Preoperative

    only. Intraoperative Intraoperative

    Percentages on the portion.

    payment files used by

    Medicare contractors

    to process Medicare

    claims.

    55................................... Postoperative Care only Postoperative Postoperative portion.

    Percentage on the

    payment files used by

    Medicare contractors

    to process Medicare

    claims.

    62................................... Co-surgeons............ 62.5%.................. 50%.

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    66................................... Team Surgeons.......... 33%.................... 33%.

    ----------------------------------------------------------------------------------------------------------------

    We also make adjustments to volume and time that correspond to other payment rules, including special multiple procedure endoscopy rules and multiple procedure payment reductions (MPPRs). We note that section 1848(c)(2)(B)(v) of the Act exempts certain reduced payments for multiple imaging procedures and multiple therapy services from the BN calculation under section 1848(c)(2)(B)(ii)(II) of the Act. These MPPRs are not included in the development of the RVUs.

    For anesthesia services, we do not apply adjustments to volume since we use the average allowed charge when simulating RVUs; therefore, the RVUs as calculated already reflect the payments as adjusted by modifiers, and no volume adjustments are necessary. However, a time adjustment of 33 percent is made only for medical direction of two to four cases since that is the only situation where a single practitioner is involved with multiple beneficiaries concurrently, so that counting each service without regard to the overlap with other services would overstate the amount of time spent by the practitioner furnishing these services.

    Work RVUs: The setup file contains the work RVUs from this proposed rule with comment period.

    (7) 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); generally 150,000 minutes.

    usage = variable, see discussion below.

    price = price of the particular piece of equipment.

    life of equipment = useful life of the particular piece of equipment.

    maintenance = factor for maintenance; 0.05.

    interest rate = variable, see discussion below.

    Usage: We currently use an equipment utilization rate assumption of 50 percent for most equipment, with the exception of expensive diagnostic imaging equipment, for which we use a 90 percent assumption as required by section 1848(b)(4)(C) of the Act. We also direct the reader to section II.5.b of this proposed rule for a discussion of our proposed change in the utilization rate assumption for the linear accelerator used in furnishing radiation treatment services.

    Maintenance: This factor for maintenance was proposed and finalized during rulemaking for CY 1998 PFS (62 FR 33164). Several stakeholders have suggested that this maintenance factor assumption should be variable, similar to other assumptions in the equipment cost per minute calculation. In CY 2015 rulemaking, we solicited comments regarding the availability of reliable data on maintenance costs that vary for particular equipment items. We received several comments about variable maintenance costs, and in reviewing the information offered in those comments, it is clear that the relationship between maintenance costs and the price of equipment is not necessarily uniform across equipment. However, based on our review of comments, we have been unable to identify a systematic way of varying the maintenance cost assumption relative to the price or useful life of equipment. Therefore, in order to accommodate a variable, as opposed to a standard, maintenance rate within the equipment cost per minute calculation, we believe we would have to gather and maintain valid data on the maintenance costs for each equipment item in the direct PE input database, much like we do for price and useful life.

    Given our longstanding difficulties in acquiring accurate pricing information for equipment items, we are seeking comment on whether adding another item-specific financial variable for equipment costs will be likely to increase the accuracy of PE RVUs across the PFS. We note that most of the information for maintenance costs we have received is for capital equipment, and for the most part, this information has been limited to single invoices. Like the invoices for the equipment items themselves, we do not believe that very small numbers of voluntarily submitted invoices are likely to reflect typical costs for all of the same reasons we have discussed in previous rulemaking. We note that some commenters submitted high-level summary data from informal surveys but we currently have no means to validate that data. Therefore, we continue to seek a source of publicly available data on actual maintenance costs for medical equipment to improve the accuracy of the equipment costs used in developing PE RVUs.

    Interest Rate: In the CY 2013 final rule with comment period (77 FR 68902), we updated the interest rates used in developing an equipment cost per minute calculation. The interest rate was based on the Small Business Administration (SBA) maximum interest rates for different categories of loan size (equipment cost) and maturity (useful life). The interest rates are listed in Table 3. (See 77 FR 68902 for a thorough discussion of this issue.)

    Table 3--SBA Maximum Interest Rates

    ------------------------------------------------------------------------

    Interest

    Price Useful life rate (%)

    ------------------------------------------------------------------------

    $50K................................ $50K................................ 7 Years............... 6.00

    ------------------------------------------------------------------------

    Page 41696

    Table 4--Calculation of PE RVUS Under Methodology for Selected Codes

    ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    33533 CABG,

    99213 Office arterial, 71020 chest x- 71020-TC chest 71020-26 chest 93000 ECG, 93005 ECG, 93010 ECG,

    Step Source Formula visit, est single ray x-ray, x-ray, complete, tracing report

    nonfacility facility nonfacility nonfacility nonfacility nonfacility nonfacility nonfacility

    ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (1) Labor cost (Lab)............... Step 1............... AMA.................. ..................... 13.32 77.52 5.74 5.74 0 5.1 5.1 0

    (2) Supply cost (Sup).............. Step 1............... AMA.................. ..................... 2.98 7.34 0.53 0.53 0 1.19 1.19 0

    (3) Equipment cost (Eqp)........... Step 1............... AMA.................. ..................... 0.17 0.58 7.08 7.08 0 0.09 0.09 0

    (4) Direct cost (Dir).............. Step 1............... ..................... =(1) (2) (3)......... 16.48 85.45 13.36 13.36 0 6.38 6.38 0

    (5) Direct adjustment (Dir. Adj.).. Steps 2-4............ See footnote*........ ..................... 0.6003 0.6003 0.6003 0.6003 0.6003 0.6003 0.6003 0.6003

    (6) Adjusted Labor................. Steps 2-4............ =Labor * Dir Adj..... =(1)*(5)............. 8 46.53 3.45 3.45 0 3.06 3.06 0

    (7) Adjusted Supplies.............. Steps 2-4............ =Eqp * Dir Adj....... =(2)*(5)............. 1.79 4.41 0.32 0.32 0 0.72 0.72 0

    (8) Adjusted Equipment............. Steps 2-4............ =Sup * Dir Adj....... =(3)*(5)............. 0.10 0.35 4.25 4.25 0 0.05 0.05 0

    (9) Adjusted Direct................ Steps 2-4............ ..................... =(6) (7) (8)......... 9.89 51.29 8.02 8.02 0 3.83 3.83 0

    (10) Conversion Factor (CF)........ Step 5............... PFS.................. ..................... 35.9335 35.9335 35.9335 35.9335 35.9335 35.9335 35.9335 35.9335

    (11) Adj. labor cost converted..... Step 5............... =(Lab * Dir Adj)/CF.. =(6)/(10)............ 0.22 1.3 0.1 0.1 0 0.09 0.09 0

    (12) Adj. supply cost converted.... Step 5............... =(Sup * Dir Adj)/CF.. =(7)/(10)............ 0.05 0.12 0.01 0.01 0 0.02 0.02 0

    (13) Adj. equipment cost converted. Step 5............... =(Eqp * Dir Adj)/CF.. =(8)/(10)............ 0 0.01 0.12 0.12 0 0 0 0

    (14) Adj. direct cost converted.... Step 5............... ..................... =(11) (12) (13)...... 0.28 1.43 0.22 0.22 0 0.11 0.11 0

    (15) Work RVU...................... Setup File........... PFS.................. ..................... 0.97 33.75 0.22 0 0.22 0.17 0 0.17

    (16) Dir_pct....................... Steps 6,7............ Surveys.............. ..................... 0.25 0.17 0.29 0.29 0.29 0.29 0.29 0.29

    (17) Ind_pct....................... Steps 6,7............ Surveys.............. ..................... 0.75 0.83 0.71 0.71 0.71 0.71 0.71 0.71

    (18) Ind. Alloc. Formula (1st part) Step 8............... See Step 8........... ..................... (14)/ (14)/ (14)/ (14)/ (14)/ (14)/ (14)/ (14)/

    (16)*(17) (16)*(17) (16)*(17) (16)*(17) (16)*(17) (16)*(17) (16)*(17) (16)*(17)

    (19) Ind. Alloc.(1st part)......... Step 8............... ..................... See 18............... 0.83 6.75 0.54 0.54 0 0.26 0.26 0

    (20) Ind. Alloc. Formula (2nd part) Step 8............... See Step 8........... ..................... (15) (15) (15 11) (11) (15) (15 11) (11) (15)

    (21) Ind. Alloc.(2nd part)......... Step 8............... ..................... See 20............... 0.97 33.75 0.32 0.1 0.22 0.26 0.09 0.17

    (22) Indirect Allocator (1st 2nd) Step 8............... ..................... =(19) (21)........... 1.8 40.50 0.86 0.64 0.22 0.52 0.35 0.17

    (23) Indirect Adjustment (Ind. Steps 9-11........... See Footnote**....... ..................... 0.3811 0.3811 0.3811 0.3811 0.3811 0.3811 0.3811 0.3811

    Adj.).

    (24) Adjusted Indirect Allocator... Steps 9-11........... =Ind Alloc * Ind Adj. ..................... 0.69 15.43 0.33 0.24 0.08 0.2 0.13 0.06

    (25) Ind. Practice Cost Index Steps 12-16.......... ..................... ..................... 1.07 0.76 0.98 0.98 0.98 0.9 0.9 0.9

    (IPCI).

    (26) Adjusted Indirect............. Step 17.............. = Adj.Ind Alloc * PCI =(24)*(25)........... 0.73 11.68 0.32 0.24 0.08 0.18 0.12 0.06

    (27) Final PE RVU.................. Step 18.............. =(Adj Dir Adj Ind) =((14) (26)) * Other 1.01 13.15 0.54 0.46 0.08 0.28 0.23 0.06

    * Other Adj. Adj).

    ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    CPT codes and descriptions are copyright 2015 American Medical Association. All Rights Reserved. Applicable FARS/DFARS apply.

    Notes: PE RVUs above (row 27), may not match Addendum B due to rounding.

    The use of any particular conversion factor (CF) in the table to illustrate the PE Calculation has no effect on the resulting RVUs.

    *The direct adj = current pe rvus * CF * avg dir pct/sum direct inputs = step2/step3; **The indirect adj =current pe rvus * avg ind pct/sum of ind allocators=step9/step10

    Page 41697

    c. Changes to Direct PE Inputs for Specific Services

    In this section, we discuss other CY 2016 proposals related to particular PE inputs. The proposed direct PE inputs are included in the proposed CY 2016 direct PE input database, which is available on the CMS Web site under downloads for the CY 2016 PFS proposed rule with comment period at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.

    (1) PE Inputs for Digital Imaging Services

    Prior to CY 2015 rulemaking, the RUC provided a recommendation regarding the PE inputs for digital imaging services. Specifically, the RUC recommended that we remove supply and equipment items associated with film technology from a list of codes since these items are no longer typical resource inputs. The RUC also recommended that the Picture Archiving and Communication System (PACS) equipment be included for these imaging services since these items are now typically used in furnishing imaging services. However, since we did not receive any invoices for the PACS system, we were unable to determine the appropriate pricing to use for the inputs. For CY 2015, we proposed, and finalized our proposal, to remove the film supply and equipment items, and to create a new equipment item as a proxy for the PACS workstation as a direct expense. We used the current price associated with ED021 (computer, desktop, w-monitor) to price the new item, ED050 (PACS Workstation Proxy), pending receipt of invoices to facilitate pricing specific to the PACS workstation.

    Subsequent to establishing payment rates for CY 2015, we received information from several stakeholders regarding pricing for items related to the digital acquisition and storage of images. Some of these stakeholders submitted information that included prices for items clearly categorized as indirect costs within the established PE methodology and equivalent to the storage mechanisms for film. Additionally, some of the invoices we received included other products (like training and maintenance costs) in addition to the equipment items, and there was no distinction on these invoices between the prices for the equipment items themselves and the related services. However, we did receive invoices from one stakeholder that facilitated a proposed price update for the PACS workstation. Therefore, we are proposing to update the price for the PACS workstation to $5,557 from the current price of $2,501 since the latter price was based on the proxy item and the former based on submitted invoices. The PE RVUs in Addendum B on the CMS Web site reflect the updated price.

    In addition to the workstation used by the clinical staff acquiring the images and furnishing the technical component of the services, a stakeholder also submitted more detailed information regarding a workstation used by the practitioner interpreting the image in furnishing the professional component of many of these services. As we stated in the CY 2015 final rule with comment period (79 FR 67563), we generally believe that workstations used by these practitioners are more accurately considered indirect costs associated with the professional component of the service. However, we understand that the professional workstations for interpretation of digital images are similar in principle to some of the previous film inputs incorporated into the global and technical components of the codes. Given that many of these services are reported globally in the nonfacility setting, we believe it may be appropriate to include these costs as direct inputs for the associated HCPCS codes. Based on our established methodology, these costs would be incorporated into the PE RVUs of the global and technical component of the HCPCS code. We are seeking comment on whether including the professional workstation as a direct PE input for these codes would be appropriate, given that the resulting PE RVUs would be assigned to the global and technical components of the codes.

    Another stakeholder expressed concern about the changes in direct PE inputs for CPT code 76377, (3D radiographic procedure with computerized image post-processing), that were proposed and finalized in CY 2015 rulemaking as part of the film to digital change. Based on a recommendation from the RUC, we removed the input called ``computer workstation, 3D reconstruction CT-MR'' from the direct PE input database and assigned the associated minutes to the proxy for the PACS workstation. We are seeking comment from stakeholders, including the RUC, about whether or not the PACS workstation used in in imaging codes is the same workstation that is used in the postprocessing described by CPT code 76377, or if more specific workstation should be incorporated in the direct PE input database . . .

    (2) Standardization of Clinical Labor Tasks

    As we noted in PFS rulemaking for CY 2015, we continue to work on revisions to the direct PE input database to provide the number of clinical labor minutes assigned for each task for every code in the database instead of only including the number of clinical labor minutes for the pre-service, service, and post-service periods for each code. In addition to increasing the transparency of the information used to set PE RVUs, this improvement would allow us to compare clinical labor times for activities associated with services across the PFS, which we believe is important to maintaining the relativity of the direct PE inputs. This information will facilitate the identification of the usual numbers of minutes for clinical labor tasks and the identification of exceptions to the usual values. It will also allow for greater transparency and consistency in the assignment of equipment minutes based on clinical labor times. Finally, we believe that the information can be useful in maintaining standard times for particular clinical labor tasks that can be applied consistently to many codes as they are valued over several years, similar in principle to the use of physician pre-service time packages. We believe such standards will provide greater consistency among codes that share the same clinical labor tasks and could improve relativity of values among codes. For example, as medical practice and technologies change over time, changes in the standards could be updated at once for all codes with the applicable clinical labor tasks, instead of waiting for individual codes to be reviewed.

    While this work is not yet complete, we anticipate completing it in the near future. In the following paragraphs, we address a series of issues related to clinical labor tasks, particularly relevant to services currently being reviewed under the misvalued code initiative

    (a) Clinical Labor Tasks Associated With Digital Imaging

    In PFS rulemaking for CY 2015, we noted that the RUC recommendation regarding inputs for digital imaging services indicated that, as each code is reviewed under the misvalued code initiative, the clinical labor tasks associated with digital technology (instead of film) would need to be addressed. When we reviewed that recommendation, we did not have the capability of assigning standard clinical labor times for the hundreds of individual codes since the direct PE

    Page 41698

    input database did not previously allow for comprehensive adjustments for clinical labor times based on particular clinical labor tasks. Therefore, consistent with the recommendation, we proposed to remove film-based supply and equipment items but maintain clinical labor minutes that were assigned based on film technology.

    As noted in the paragraphs above, we continue to improve the direct PE input database by specifying the minutes for each code associated with each clinical labor task. Once completed, this work would allow adjustments to be made to minutes assigned to particular clinical labor tasks related to digital technology, consistent with the changes that were made to individual supply and equipment items. In the meantime, we believe it would be appropriate to establish standard times for clinical labor tasks associated with all digital imaging for purposes of reviewing individual services at present, and for possible broad-

    based standardization once the changes to the database facilitate our ability to adjust time for existing services. Therefore, we are seeking comment on the appropriate standard minutes for the clinical labor tasks associated with services that use digital technology, which are listed in Table 5. We note that the application of any standardized times we adopt for clinical labor tasks to codes that are not being reviewed in this proposed rule would be considered for possible inclusion in future notice and comment rulemaking.

    Table 5--Clinical Labor Tasks Associated With Digital Technology

    ------------------------------------------------------------------------

    Clinical labor task Typical minutes

    ------------------------------------------------------------------------

    Availability of prior images confirmed............... 2

    Patient clinical information and questionnaire 2

    reviewed by technologist, order from physician

    confirmed and exam protocoled by radiologist........

    Technologist QC's * images in PACS, checking for all 2

    images, reformats, and dose page....................

    Review examination with interpreting MD.............. 2

    Exam documents scanned into PACS. Exam completed in 1

    RIS system to generate billing process and to

    populate images into Radiologist work queue.........

    ------------------------------------------------------------------------

    * This clinical labor task is listed as it appears on the ``PE

    worksheets.'' QC refers to quality control, which we understand to

    mean the verification of the image using the PACS workstation.

    (b) Pathology Clinical Labor Tasks

    As with the clinical labor tasks associated with digital imaging, many of the specialized clinical labor tasks associated with pathology services do not have consistent times across those codes. In reviewing the recommendations for pathology services, we have not identified information that suggests that the inconsistencies reflect the judgment that the same tasks take significantly more or less time depending on the individual service for which they are performed, especially given the specificity with which they are described.

    We have therefore developed proposed standard times that we have used in proposing direct PE inputs. These times are based on our review and assessment of the current times included for these clinical labor tasks in the direct PE input database. We have listed these proposed standard times in Table 6. For services reviewed for CY 2016, in cases where the RUC-recommended times differed from these standards, we have refined the time for those tasks to align with the values in Table 6. We seek comment on whether these standard times accurately reflect the typical time it takes to perform these clinical labor tasks when furnishing pathology services.

    Table 6--Standard Times for Clinical Labor Tasks Associated With

    Pathology Services

    ------------------------------------------------------------------------

    Standard clinical

    Clinical Labor Task labor time

    ------------------------------------------------------------------------

    Accession specimen/prepare for examination.......... 4

    Assemble and deliver slides with paperwork to 0.5

    pathologists.......................................

    Assemble other light microscopy slides, open nerve 0.5

    biopsy slides, and clinical history, and present to

    pathologist to prepare clinical pathologic

    interpretation.....................................

    Assist pathologist with gross specimen examination.. 3

    Clean room/equipment following procedure (including 1

    any equipment maintenance that must be done after

    the procedure).....................................

    Dispose of remaining specimens, spent chemicals/ 1

    other consumables, and hazardous waste.............

    Enter patient data, computational prep for antibody 1

    testing, generate and apply bar codes to slides,

    and enter data for automated slide stainer.........

    Instrument start-up, quality control functions, 13

    calibration, centrifugation, maintaining specimen

    tracking, logs and labeling........................

    Load specimen into flow cytometer, run specimen, 7

    monitor data acquisition and data modeling, and

    unload flow cytometer..............................

    Preparation: labeling of blocks and containers and 0.5

    document location and processor used...............

    Prepare automated stainer with solutions and load 4

    microscopic slides.................................

    Prepare specimen containers/preload fixative/label 0.5

    containers/distribute requisition form(s) to

    physician..........................................

    Prepare, pack and transport specimens and records 1

    for in-house storage and external storage (where

    applicable)........................................

    Print out histograms, assemble materials with 2

    paperwork to pathologists. Review histograms and

    gating with pathologist............................

    Receive phone call from referring laboratory/ 5

    facility with scheduled procedure to arrange

    special delivery of specimen procurement kit,

    including muscle biopsy clamp as needed. Review

    with sender instructions for preservation of

    specimen integrity and return arrangements. Contact

    courier and arrange delivery to referring

    laboratory/facility................................

    Register the patient in the information system, 4

    including all demographic and billing information..

    Stain air dried slides with modified Wright stain. 3

    Review slides for malignancy/high cellularity

    (cross contamination)..............................

    ------------------------------------------------------------------------

    Page 41699

    (c) Clinical Labor Task: ``Complete Botox Log''

    In the process of improving the level of detail in the direct PE input database by including the minutes assigned for each clinical labor task, we noticed that there are several codes with minutes assigned for the clinical labor task called ``complete botox log.'' We do not believe the completion of such a log is a direct resource cost of furnishing a medically reasonable and necessary physician's service for a Medicare beneficiary. Therefore, we are proposing to eliminate the minutes assigned for the task ``complete botox log'' from the direct PE input database. The PE RVUs displayed in Addendum B on the CMS Web site were calculated with the modified inputs displayed in the CY 2016 direct PE input database.

    (3) Clinical Labor Input Inconsistencies

    Subsequent to the publication of the CY 2015 PFS final rule with comment period, stakeholders alerted us to several clerical inconsistencies in the clinical labor nonfacility intraservice time for several vertebroplasty codes with interim final values for CY 2015, based on our understanding of RUC recommended values. We are proposing to correct these inconsistencies in the CY 2016 proposed direct PE input database to reflect the RUC recommended values, without refinement, as stated in the CY 2015 PFS final rule with comment period. The CY 2015 interim final direct PE inputs for these codes are displayed on the CMS Web site under downloads for the CY 2015 PFS final rule with comment period at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. For CY 2016, we are proposing the following adjustments. For CPT codes 22510 (percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance; cervicothoracic) and 22511 (percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance; lumbosacral), a value of 45 minutes for labor code L041B (``Radiologic Technologist'') were are proposing to assign for the ``assist physician'' task and a value of 5 minutes for labor code L037D (``RN/LPN/MTA'') for the ``Check dressings & wound/home care instructions/coordinate office visits/prescriptions'' task. For CPT code 22514 (percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (eg, kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; lumbar), we are proposing to adjust the nonfacility intraservice time to 50 minutes for L041B, 50 minutes for L051A (``RN''), 38 minutes for a second L041B, and 12 minutes for L037D. The PE RVUs displayed in Addendum B on the CMS Web site were calculated with the inputs displayed in the CY 2016 direct PE input database.

    (4) Freezer

    We identified several pathology codes for which equipment minutes are assigned to the item EP110 ``Freezer.'' Minutes are only allocated to particular equipment items when those items cannot be used in conjunction with furnishing services to another patient at the same time. We do not believe that minutes should be allocated to items such as freezers since the storage of any particular specimen or item in a freezer for any given period of time would be unlikely to make the freezer unavailable for storing other specimens or items. Instead, we propose to classify the freezer as an indirect cost because we believe that would be most consistent with the principles underlying the PE methodology since freezers can be used for many specimens at once. The PE RVUs displayed in Addendum B on the CMS Web site were calculated with the modified inputs displayed in the CY 2016 direct PE input database.

    (5) Updates to Price for Existing Direct Inputs

    In the CY 2011 PFS final rule with comment period (75 FR 73205), we finalized a process to act on public requests to update equipment and supply price and equipment useful life inputs through annual rulemaking beginning with the CY 2012 PFS proposed rule. During 2014, we received a request to update the price of supply item ``antigen, mite'' (SH006) from $4.10 per test to $59. In reviewing the request, it is evident that the requested price update does not apply to the SH006 item but instead represents a different item than the one currently included as an input in CPT code 86490 (skin test, coccidioidomycosis). Therefore, rather than changing the price for SH006 that is included in several codes, we are proposing to create a new supply code for Spherusol, valued at $590 per 1 ml vial and $59 per test, and to include this new item as a supply for 86490 instead of the current input, SH006. We also received a request to update the price for EQ340 (Patient Worn Telemetry System) used only in CPT code 93229 (External mobile cardiovascular telemetry with electrocardiographic recording, concurrent computerized real time data analysis and greater than 24 hours of accessible ECG data storage (retrievable with query) with ECG triggered and patient selected events transmitted to a remote attended surveillance center for up to 30 days; technical support for connection and patient instructions for use, attended surveillance, analysis and transmission of daily and emergent data reports as prescribed by a physician or other qualified health care.) The requestor noted that we had previously proposed and finalized a policy to remove wireless communication and delivery costs related to the equipment item that had previously been included in the direct PE input database as supply items. The requestor asked that we alter the price of the equipment from $21,575 to $23,537 to account for the equipment costs specific to the patient-worn telemetry system.

    We have considered this request in the context of the unique nature of this particular equipment item. This equipment item is unique in several ways, including that it is used continuously 24 hours per day and 7 days per week for an individual patient over several weeks. It is also unique in that the equipment is primarily used outside of a healthcare setting. Within our current methodology, we currently account for these unique properties by calculating the per minute costs with different assumptions than those used for most other equipment by increasing the number of hours the equipment is available for use. Therefore, we also believe it would be appropriate to incorporate other unique aspects of the operating costs of this item in our calculation of the equipment cost per minute. We believe the requestor's suggestion to do so by increasing the price of the equipment is practicable and appropriate. Therefore, we are proposing to change the price for EQ340 (Patient Worn Telemetry System) to $23,537. The PE RVUs displayed in Addendum B on the CMS Web site were calculated with the modified inputs displayed in the CY 2016 direct PE input database.

    For CY 2015, we received a request to update the price for supply item ``kit, HER-2/neu DNA Probe'' (SL196) from $105 to $144.50. Accordingly, we proposed to update the price to $144.50. In the CY 2015 final rule with comment period, we indicated that we obtained new information suggesting that further study of the price of this item was necessary before proceeding to update

    Page 41700

    the input price. We obtained pricing information readily available on the Internet that indicated a price of $94 for this item for a particular hospital. Subsequent to the CY 2015 final rule with comment period, stakeholders requested that we use the updated price of $144.50. One stakeholder suggested that the price of $94 likely reflected discounts for volume purchases not received by the typical laboratory. We are seeking comment on how to consider the higher-priced invoice, which is 53 percent higher than the price listed, relative to the price currently in the direct PE database. Specifically, we are seeking information on the price of the disposable supply in the typical case of the service furnished to a Medicare beneficiary, including, based on data, whether the typical Medicare case is furnished by an entity likely to receive a volume discount.

    (6) Typical Supply and Equipment Inputs for Pathology Services

    In reviewing public comments in response to the CY 2015 PFS final rule with comment period, we re-examined issues around the typical number of pathology tests furnished at once. In the CY 2013 final rule with comment period (77 FR 69074), we noted that the number of blocks assumed for a particular code significantly impacts the assumed clinical labor, supplies, and equipment for that service. We indicated that we had concerns that the assumed number of blocks was inaccurate, and that we sought corroborating, independent evidence that the number of blocks assumed in the current direct PE input recommendations is typical. We note that, given the high volume of many pathology services, these assumptions have a significant impact on the PE RVUs for all other PFS services. We refer readers to section II.I.5.d where we detail our concerns about the lack of information regarding typical batch size and typical block size for many pathology services and solicit stakeholder input on approaches to obtaining accurate information that can facilitate our establishing payment rates that best reflect the relative resources involved in furnishing the typical service, for both pathology services in particular and more broadly for services across the PFS.

    d. Developing Nonfacility Rates

    We note that not all PFS services are priced in the nonfacility setting, but as medical practice changes, we routinely develop nonfacility prices for particular services when they can be furnished outside of a facility setting. We note that the valuation of a service under the PFS in particular settings does not address whether those services are medically reasonable and necessary in the case of individual patients, including being furnished in a setting appropriate to the patient's medical needs and condition.

    (1) Request for Information on Nonfacility Cataract Surgery

    Cataract surgery generally has been performed in an ambulatory surgery center (ASC) or a hospital outpatient department (HOPD). Therefore, CMS has not assigned nonfacility PE RVUs under the PFS for cataract surgery. According to Medicare claims data, there are a relatively small number of these services furnished in nonfacility settings. Except in unusual circumstances, anesthesia for cataract surgery is either local or topical/intracameral. Advancements in technology have significantly reduced operating time and improved both the safety of the procedure and patient outcomes. We believe that it is now possible for cataract surgery to be furnished in an in-office surgical suite, especially for routine cases. Cataract surgery patients require a sterile surgical suite with certain equipment and supplies that we believe could be a part of a nonfacility-based setting that is properly constructed and maintained for appropriate infection prevention and control.

    We believe that there are potential advantages for all parties to furnishing appropriate cataract surgery cases in the nonfacility setting. Cataract surgery has been for many years the highest volume surgical procedure performed on Medicare beneficiaries. For beneficiaries, cataract surgery in the office setting might provide the additional convenience of receiving the preoperative, operative, and post-operative care in one location. It might also reduce delays associated with registration, processing, and discharge protocols associated with some facilities. Similarly, it might provide surgeons with greater flexibility in scheduling patients at an appropriate site of service depending on the individual patient's needs. For example, routine cases in patients with no comorbidities could be performed in the nonfacility surgical suite, while more complicated cases (for example, pseudoexfoliation) could be scheduled in the ASC or HOPD. In addition, furnishing cataract surgery in the nonfacility setting could result in lower Medicare expenditures for cataract surgery if the nonfacility payment rate were lower than the sum of the PFS facility payment rate and the payment to either the ASC or HOPD.

    We are seeking comments from ophthalmologists and other stakeholders on office-based surgical suite cataract surgery. In addition, we are soliciting comments from the RUC and other stakeholders on the direct practice expense inputs involved in furnishing cataract surgery in the nonfacility setting in conjunction with our consideration of information regarding the possibility of developing nonfacility PE RVUs for cataract surgery. We understand that cataract surgery generally requires some standard equipment and supplies (for example; phacoemulsification machine, surgical pack, intraocular lenses (IOL), etc.) that would be incorporated as direct PE inputs in calculating nonfacility PE RVUs.

    (2) Direct PE Inputs for Functional Endoscopic Sinus Surgery Services

    A stakeholder indicated that due to changes in technology and technique, several codes that describe endoscopic sinus surgeries can now be furnished in the nonfacility setting. According to Medicare claims data, there are a relatively small number of these services furnished in nonfacility settings. These CPT codes are 31254 (Nasal/

    sinus endoscopy, surgical; with ethmoidectomy, partial (anterior)), 31255 (Nasal/sinus endoscopy, surgical; with ethmoidectomy, total (anterior and posterior)), 31256 (Nasal/sinus endoscopy, surgical, with maxillary antrostomy;), 31267 (Nasal/sinus endoscopy, surgical, with maxillary antrostomy; with removal of tissue from maxillary sinus), 31276 (Nasal/sinus endoscopy, surgical with frontal sinus exploration, with or without removal of tissue from frontal sinus), 31287 (Nasal/

    sinus endoscopy, surgical, with sphenoidotomy;), and 31288 (Nasal/sinus endoscopy, surgical, with sphenoidotomy; with removal of tissue from the sphenoid sinus). We are seeking input from stakeholders, including the RUC, about the appropriate direct PE inputs for these services.

  30. Determination of Malpractice Relative Value Units (RVUs)

    1. Overview

    Section 1848(c) of the Act requires that each service paid under the PFS be comprised of three components: work, PE, and malpractice (MP) expense. As required by section 1848(c)(2)(C)(iii) of the Act, beginning in CY 2000, MP RVUs are resource based. Malpractice RVUs for new codes after 1991 were

    Page 41701

    extrapolated from similar existing codes or as a percentage of the corresponding work RVU. Section 1848(c)(2)(B)(i) of the Act also requires that we review, and if necessary adjust, RVUs no less often than every 5 years. In the CY 2015 PFS final rule with comment period, we implemented the third review and update of MP RVUs. For a discussion of the third review and update of MP RVUs see the CY 2015 proposed rule (79 FR 40349 through 40355) and final rule with comment period (79 FR 67591 through 67596).

    As explained in the CY 2011 PFS final rule with comment period (75 FR 73208), MP RVUs for new and revised codes effective before the next five-year review of MP RVUs (for example, effective CY 2016 through CY 2019, assuming that the next review of MP RVUs occurs for CY 2020) are determined either by a direct crosswalk from a similar source code or by a modified crosswalk to account for differences in work RVUs between the new/revised code and the source code. For the modified crosswalk approach, we adjust (or ``scale'') the MP RVU for the new/revised code to reflect the difference in work RVU between the source code and the new/revised work value (or, if greater, the clinical labor portion of the fully implemented PE RVU) for the new code. For example, if the proposed work RVU for a revised code is 10 percent higher than the work RVU for its source code, the MP RVU for the revised code would be increased by 10 percent over the source code MP RVU. Under this approach the same risk factor is applied for the new/revised code and source code, but the work RVU for the new/revised code is used to adjust the MP RVUs for risk.

    For CY 2016, we propose to continue our current approach for determining MP RVUs for new/revised codes. For the new and revised codes for which we include proposed work values and PE inputs in the proposed rule, we will also publish the proposed MP crosswalks used to determine their MP RVUs in the proposed rule. The MP crosswalks for those new and revised codes will be subject to public comment and finalized in the CY 2016 PFS final rule. The MP crosswalks for new and revised codes with interim final values established in the CY 2016 final rule will be implemented for CY 2016 and subject to public comment. They will then be finalized in the CY 2017 PFS final rule with comment period.

    2. Proposed Annual Update of MP RVUs

    In the CY 2012 PFS final rule with comment period (76 FR 73057), we finalized a process to consolidate the five-year reviews of physician work and PE RVUs with our annual review of potentially misvalued codes. We discussed the exclusion of MP RVUs from this process at the time, and we stated that, since it is not feasible to obtain updated specialty level MP insurance premium data on an annual basis, we believe the comprehensive review of MP RVUs should continue to occur at 5-year intervals. In the CY 2015 PFS proposed rule (79 FR 40349 through 40355), we stated that there are two main aspects to the update of MP RVUs: (1) Recalculation of specialty risk factors based upon updated premium data; and (2) recalculation of service level RVUs based upon the mix of practitioners providing the service. In the CY 2015 PFS final rule with comment period (79 FR 67596), in response to several stakeholders' comments, we stated that we would address potential changes regarding the frequency of MP RVU updates in a future proposed rule. For CY 2016, we are proposing to begin conducting annual MP RVU updates to reflect changes in the mix of practitioners providing services, and to adjust MP RVUs for risk. Under this approach, the specialty-specific risk factors would continue to be updated every five years using updated premium data, but would remain unchanged between the 5-year reviews. However, in an effort to ensure that MP RVUs are as current as possible, our proposal would involve recalibrating all MP RVUs on an annual basis to reflect the specialty mix based on updated Medicare claims data. Since under this proposal, we would be recalculating the MP RVUs annually, we are also proposing to maintain the relative pool of MP RVUs from year to year; this will preserve the relative weight of MP RVUs to work and PE RVUs. We are proposing to calculate the current pool of MP RVUs by using a process parallel to the one we use in calculating the pool of PE RVUs. (We direct the reader to section II.2.b.(6) for detailed description of that process, including a proposed technical revision for 2016.) To determine the specialty mix assigned to each code, we are also proposing to use the same process used in the PE methodology, described in section II.2.b.(6) of this proposed rule. We note that for CY 2016, we are proposing to modify the specialty mix assignment methodology to use an average of the 3 most recent years of available data instead of a single year of data as is our current policy. We anticipate that this change will increase the stability of PE and MP RVUs and mitigate code-

    level fluctuations for all services paid under the PFS, and for new and low-volume codes in particular. We are also proposing to no longer apply the dominant specialty for low volume services, because the primary rationale for the policy has been mitigated by this proposed change in methodology. However, we are not proposing to adjust the code-specific overrides established in prior rulemaking for codes where the claims data are inconsistent with a specialty that could be reasonably expected to furnish the service. We believe that these proposed changes will serve to balance the advantages of using annually updated information with the need for year-to-year stability in values. We seek comment on both aspects of the proposal: updating the specialty mix for MP RVUs annually (while continuing to update specialty-specific risk factors every 5 years using updated premium data); and using the same process to determine the specialty mix assigned to each code as is used in the PE methodology, including the proposed modification to use the most recent 3 years of claims data. We also seek comment on whether this approach will be helpful in addressing some of the concerns regarding the calculation of MP RVUs for services with low volume in the Medicare population, including the possibility of limiting our use of code-specific overrides of the claims data.

    We are also proposing an additional refinement in our process for assigning MP RVUs to individual codes. Historically, we have used a floor of 0.01 MP RVUs for all nationally-priced PFS codes. This means that even when the code-level calculation for the MP RVU falls below 0.005, we have rounded to 0.01. In general, we believe this approach accounts for the minimum MP costs associated with each service furnished to a Medicare beneficiary. However, in examining the calculation of MP RVUs, we do not believe that this floor should apply to add-on codes. Since add-on codes must be reported with another code, there is already an MP floor of 0.01 that applies to the base code, and therefore, to each individual service. By applying the floor to add-on codes, the current methodology practically creates a 0.02 floor for any service reported with one add-on code, and 0.03 for those with 2 add-on codes, etc. Therefore, we are proposing to maintain the 0.01 MP RVU floor for all nationally-priced PFS services that are described by base codes, but not for add-on codes. We will continue to calculate, display, and make payments that include MP RVUs for

    Page 41702

    add-on codes that are calculated to 0.01 or greater, including those that round to 0.01. We are only proposing to allow the MP RVUs for add-

    on codes to round to 0.00 where the calculated MP RVU is less than 0.005.

    We will continue to study the appropriate frequency for collecting and updating premium data and will address any further proposed changes in future rulemaking.

    3. MP RVU Update for Anesthesia Services

    In the CY 2015 PFS proposed rule (79 FR 40354 through 40355), we did not include an adjustment under the anesthesia fee schedule to reflect updated MP premium information, and stated that we intended to propose an anesthesia adjustment for MP in the CY 2016 PFS proposed rule. We also solicited comments regarding how to best reflect updated MP premium amounts under the anesthesiology fee schedule.

    As we previously explained, anesthesia services under the PFS are paid based upon a separate fee schedule, so routine updates must be calculated in a different way than those for services for which payment is calculated based upon work, PE, and MP RVUs. To apply budget neutrality and relativity updates to the anesthesiology fee schedule, we typically develop proxy RVUs for individual anesthesia services that are derived from the total portion of PFS payments made through the anesthesia fee schedule. We then update the proxy RVUs as we would the RVUs for other PFS services and adjust the anesthesia fee schedule conversion factor based on the differences between the original proxy RVUs and those adjusted for relativity and budget neutrality.

    We believe that taking the same approach to update the anesthesia fee schedule based on new MP premium data is appropriate. However, because work RVUs are integral to the MP RVU methodology and anesthesia services do not have work RVUs, we decided to seek potential alternatives prior to implementing our approach in conjunction with the proposed CY 2015 MP RVUs based on updated premium data. One commenter supported the delay in proposing to update the MP for anesthesia at the same time as updating the rest of the PFS, and another commenter suggested using mean anesthesia MP premiums per provider over a 4 or 5 year period prorated by Medicare utilization to yield the MP expense for anesthesia services; no commenters offered alternatives to calculating updated MP for anesthesia services. The latter suggestion might apply more broadly to the MP methodology for the PFS and does not address the methodology as much as the data source.

    We continue to believe that payment rates for anesthesia should reflect MP resource costs relative to the rest of the PFS, including updates to reflect changes over time. Therefore, for CY 2016, in order to appropriately update the MP resource costs for anesthesia, we are proposing to make adjustments to the anesthesia conversion factor to reflect the updated premium information collected for the five year review. To determine the appropriate adjustment, we calculated imputed work RVUs and MP RVUs for the anesthesiology fee schedule services using the work, PE, and MP shares of the anesthesia fee schedule. Again, this is consistent with our longstanding approach to making annual adjustments to the PE and work RVU portions of the anesthesiology fee schedule. To reflect differences in the complexity and risk among the anesthesia fee schedule services, we multiplied the service-specific risk factor for each anesthesia fee schedule service by the CY 2016 imputed proxy work RVUs and used the product as the updated raw proxy MP RVUs for each anesthesia service for CY 2016. We then applied the same scaling adjustments to these raw proxy MP RVUs that we apply to the remainder of the PFS MP RVUs. Finally, we calculated the aggregate difference between the 2015 proxy MP RVUs and the proxy MP RVUs calculated for CY 2016. We then adjusted the portion of the anesthesia conversion factor attributable to MP proportionately; we refer the reader to section VI.C. of this proposed rule for the Anesthesia Fee Schedule Conversion Factors for CY 2016. We are inviting public comments regarding this proposal.

    4. MP RVU Methodology Refinements

    In the CY 2015 PFS final rule with comment period (79 FR 67591 through 67596), we finalized updated MP RVUs that were calculated based on updated MP premium data obtained from state insurance rate filings. The methodology used in calculating the finalized CY 2015 review and update of resource-based MP RVUs largely paralleled the process used in the CY 2010 update. We posted our contractor's report, ``Final Report on the CY 2015 Update of Malpractice RVUs'' on the CMS Web site. It is also located under the supporting documents section of the CY 2015 PFS final rule with comment period located at http://www.cms.gov/PhysicianFeeSched/. A more detailed explanation of the 2015 MP RVU update can be found in the CY 2015 PFS proposed rule (79 FR 40349 through 40355).

    In the CY 2015 PFS proposed rule, we outlined the steps for calculating MP RVUs. In the process of calculating MP RVUs for purposes of this proposed rule, we have identified a necessary refinement to way we have calculated Step 1, which involves computing a preliminary national average premium for each specialty, to align the calculations within the methodology to the calculations described within the aforementioned contractor's report. Specifically, in the calculation of the national premium for each specialty (refer to equations 2.3, 2.4, 2.5 in the aforementioned contractor's report), we calculate a weighted sum of premiums across areas and divide it by a weighted sum of MP GPCIs across areas. The calculation currently takes the ratio of sums, rather than the weighted average of the local premiums to the MP GPCI in that area. Instead, we are proposing to update the calculation to use a price-adjusted premium (that is, the premium divided by the GPCI) in each area, and then taking a weighted average of those adjusted premiums. The CY 2016 PFS proposed rule MP RVUs were calculated in this manner.

    Additionally, in the calculation of the national average premium for each specialty as discussed above, our current methodology used the total RVUs in each area as the weight in the numerator (that is, for premiums), and total MP RVUs as the weights in the denominator (that is, for the MP GPCIs). After further consideration, we believe that the use of these RVU weights is problematic. Use of weights that are central to the process at hand presents potential circularity since both weights incorporate MP RVUs as part of the computation to calculate MP RVUs. The use of different weights for the numerator and denominator introduces potential inconsistency. Instead, we believe that it would be better to use a different measure that is independent of MP RVUs and better represents the reason for weighting. Specifically, we are proposing to use area population as a share of total U.S. population as the weight. The premium data are for all MP premium costs, not just those associated with Medicare patients, so we believe that the distribution of the population does a better job of capturing the role of each area's premium in the ``national'' premium for each specialty than our previous Medicare-specific measure. Use of population weights also avoids the potential problems of circularity and inconsistency.

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    The CY 2016 PFS proposed MP RVUs, as displayed in Addendum B of this proposed rule, reflect MP RVUs calculated following our established methodology, with the inclusion of the proposals and refinements described above.

  31. Potentially Misvalued Services Under the Physician Fee Schedule

    1. Background

    Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a periodic review, not less often than every 5 years, of the RVUs established under the PFS. Section 1848(c)(2)(K) of the Act requires the Secretary to periodically identify potentially misvalued services using certain criteria and to review and make appropriate adjustments to the relative values for those services. Section 1848(c)(2)(L) to the Act also requires the Secretary to develop a process to validate the RVUs of certain potentially misvalued codes under the PFS, using the same criteria used to identify potentially misvalued codes, and to make appropriate adjustments.

    As discussed in section I.B. of this proposed rule, each year we develop appropriate adjustments to the RVUs taking into account recommendations provided by the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC), the Medicare Payment Advisory Commission (MedPAC), and others. For many years, the RUC has provided us with recommendations on the appropriate relative values for new, revised, and potentially misvalued PFS services. We review these recommendations on a code-by-code basis and consider these recommendations in conjunction with analyses of other data, such as claims data, to inform the decision-making process to establish relative values for these codes. We may also consider analyses of work time, work RVUs, or direct practice expense (PE) inputs using other data sources, such as Department of Veteran Affairs (VA), National Surgical Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons (STS), and the Physician Quality Reporting System (PQRS) databases. In addition to considering the most recently available data, we also assess the results of physician surveys and specialty recommendations submitted to us by the RUC. We also consider information provided by other stakeholders. We conduct a review to assess the appropriate RVUs in the context of contemporary medical practice. We note that section 1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and other techniques to determine the RVUs for physicians' services for which specific data are not available, in addition to requiring us to take into account the results of consultations with organizations representing physicians who furnish the services. In accordance with section 1848(c) of the Act, we determine and make appropriate adjustments to the RVUs. We discuss these methodologies as applied to particular codes in section I.B. of this proposed rule.

    Section 1848(c)(2)(K)(ii) of the Act augments our efforts by directing the Secretary to specifically examine, as determined appropriate, potentially misvalued services in the following categories:

    Codes that have experienced the fastest growth.

    Codes that have experienced substantial changes in practice expenses.

    Codes that describe new technologies or services within an appropriate time period (such as 3 years) after the relative values are initially established for such codes.

    Codes which are multiple codes that are frequently billed in conjunction with furnishing a single service.

    Codes with low relative values, particularly those that are often billed multiple times for a single treatment.

    Codes that have not been subject to review since implementation of the fee schedule.

    Codes that account for the majority of spending under the PFS.

    Codes for services that have experienced a substantial change in the hospital length of stay or procedure time.

    Codes for which there may be a change in the typical site of service since the code was last valued.

    Codes for which there is a significant difference in payment for the same service between different sites of service.

    Codes for which there may be anomalies in relative values within a family of codes.

    Codes for services where there may be efficiencies when a service is furnished at the same time as other services.

    Codes with high intra-service work per unit of time.

    Codes with high practice expense relative value units.

    Codes with high cost supplies.

    Codes as determined appropriate by the Secretary.

    Section 1848(c)(2)(K)(iii) of the Act also specifies that the Secretary may use existing processes to receive recommendations on the review and appropriate adjustment of potentially misvalued services. In addition, the Secretary may conduct surveys, other data collection activities, studies, or other analyses, as the Secretary determines to be appropriate, to facilitate the review and appropriate adjustment of potentially misvalued services. This section also authorizes the use of analytic contractors to identify and analyze potentially misvalued codes, conduct surveys or collect data, and make recommendations on the review and appropriate adjustment of potentially misvalued services. Additionally, this section provides that the Secretary may coordinate the review and adjustment of any RVU with the periodic review described in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of the Act specifies that the Secretary may make appropriate coding revisions (including using existing processes for consideration of coding changes) that may include consolidation of individual services into bundled codes for payment under the PFS.

    2. Progress in Identifying and Reviewing Potentially Misvalued Codes

    To fulfill our statutory mandate, we have identified and reviewed numerous potentially misvalued codes as specified in section 1848(c)(2)(K)(ii) of the Act, and we plan to continue our work examining potentially misvalued codes in these areas over the upcoming years. As part of our current process, we identify potentially misvalued codes for review, and request recommendations from the RUC and other public commenters on revised work RVUs and direct PE inputs for those codes. The RUC, through its own processes, also identifies potentially misvalued codes for review. Through our public nomination process for potentially misvalued codes established in the CY 2012 PFS final rule with comment period, other individuals and stakeholder groups submit nominations for review of potentially misvalued codes as well.

    Since CY 2009, as a part of the annual potentially misvalued code review and Five-Year Review process, we have reviewed over 1,560 potentially misvalued codes to refine work RVUs and direct PE inputs. We have assigned appropriate work RVUs and direct PE inputs for these services as a result of these reviews. A more detailed discussion of the extensive prior reviews of potentially misvalued codes is included in the CY 2012 PFS final rule with comment period (76 FR 73052

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    through 73055). In the CY 2012 final rule with comment period, we finalized our policy to consolidate the review of physician work and PE at the same time (76 FR 73055 through 73958), and established a process for the annual public nomination of potentially misvalued services.

    In the CY 2013 final rule with comment period, we built upon the work we began in CY 2009 to review potentially misvalued codes that have not been reviewed since the implementation of the PFS (so-called ``Harvard-valued codes''). In CY 2009, we requested recommendations from the RUC to aid in our review of Harvard-valued codes that had not yet been reviewed, focusing first on high-volume, low intensity codes (73 FR 38589). In the Fourth Five-Year Review, we requested recommendations from the RUC to aid in our review of Harvard-valued codes with annual utilization of greater than 30,000 (76 FR 32410). In the CY 2013 final rule with comment period, we identified as potentially misvalued Harvard-valued services with annual allowed charges that total at least $10,000,000. In addition to the Harvard-

    valued codes, in the CY 2013 final rule with comment period we finalized for review a list of potentially misvalued codes that have stand-alone PE (codes with physician work and no listed work time, and codes with no physician work and listed work time).

    In the CY 2014 final rule with comment period, we finalized for review a list of potentially misvalued services. We included on the list for review ultrasound guidance codes that had longer procedure times than the typical procedure with which the code is billed to Medicare. We also finalized our proposal to replace missing post-

    operative hospital E/M visit information and work time for approximately 100 global surgery codes. In CY 2014, we also considered a proposal to limit Medicare PFS payments for services furnished in a non-facility setting when the PFS payment would exceed the combined Medicare payment made to the practitioner under the PFS and facility payment made to either the ASC or hospital outpatient. Based upon extensive public comment we did not finalize this proposal.

    In the CY 2015 final rule with comment period, we finalized a list of potentially misvalued services. The potentially misvalued codes list included the publicly nominated CPT code 41530; two neurostimulator implantation codes, CPT 64553 and 64555; four epidural injection codes, CPT 62310, 62311, 62318 and 62319; three breast mammography codes, CPT 77055, 77056 and 77057; an abdominal aortic aneurysm ultrasound screening code, HCPCS G0389; a prostate biopsy code, G0416; and an obesity behavioral group counseling code, HCPCS G0473. We also finalized our ``high expenditure services across specialty'' screen as a tool to identify potentially misvalued codes though we did not finalize the particular list of codes identified in that rule as potentially misvalued. In CY 2015, we also considered and finalized a proposal addressing the valuation and coding of global surgical packages, which would revalue and transition 10 and 90-day global codes to 0-day codes. We also sought comment on approaches to revalue services that included moderate sedation as an inherent part of furnishing the procedure.

    3. Validating RVUs of Potentially Misvalued Codes

    Section 1848(c)(2)(L) of the Act requires the Secretary to establish a formal process to validate RVUs under the PFS. The Act specifies that the validation process may include validation of work elements (such as time, mental effort and professional judgment, technical skill and physical effort, and stress due to risk) involved with furnishing a service and may include validation of the pre-, post-

    , and intra-service components of work. The Secretary is directed, as part of the validation, to validate a sampling of the work RVUs of codes identified through any of the 16 categories of potentially misvalued codes specified in section 1848(c)(2)(K)(ii) of the Act. Furthermore, the Secretary may conduct the validation using methods similar to those used to review potentially misvalued codes, including conducting surveys, other data collection activities, studies, or other analyses as the Secretary determines to be appropriate to facilitate the validation of RVUs of services.

    In the CY 2011 PFS proposed rule (75 FR 40068) and CY 2012 PFS proposed rule (76 FR 42790), we solicited public comments on possible approaches, methodologies, and data sources that we should consider for a validation process. A summary of the comments along with our responses is included in the CY 2011 PFS final rule with comment period (75 FR 73217) and the CY 2012 PFS final rule with comment period (73054 through 73055).

    We contracted with two outside entities to develop validation models for RVUs. Given the central role of time in establishing work RVUs and the concerns that have been raised about the current time values used in rate setting, we contracted with the Urban Institute to collect time data from several practices for services selected by the contractor in consultation with CMS. Urban Institute has used a variety of approaches to develop objective time estimates, depending on the type of service. Objective time estimates will be compared to the current time values used in the fee schedule. The project team will then convene groups of physicians from a range of specialties to review the new time data and the potential implications for work and the ratio of work to time. Urban Institute has prepared an interim report, ``Development of a Model for the Valuation of Work Relative Value Units,'' which discusses the challenges encountered in collecting objective time data and offers some thoughts on how these can be overcome. This interim report is posted on the CMS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/RVUs-Validation-UrbanInterimReport.pdf. A final report will be available once the project is complete.

    The second contract is with the RAND Corporation, which is using available data to build a validation model to predict work RVUs and the individual components of work RVUs, time and intensity. The model design was informed by the statistical methodologies and approach used to develop the initial work RVUs and to identify potentially misvalued procedures under current CMS and RUC processes. RAND consulted with a technical expert panel on model design issues and the test results. The RAND report is available on the CMS Web site under downloads for the CY 2015 PFS Final Rule with Comment Period at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices-Items/CMS-1612-FC.html.

    4. CY 2016 Identification of Potentially Misvalued Services for Review

    a. Public Nomination of Potentially Misvalued Codes

    In the CY 2012 PFS final rule with comment period, we finalized a process for the public to nominate potentially misvalued codes (76 FR 73058). The public and stakeholders may nominate potentially misvalued codes for review by submitting the code with supporting documentation during the 60-day public comment period following the release of the annual PFS final rule with comment period. Supporting documentation for codes nominated for the annual review of potentially misvalued codes may

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    include, but are not limited to, the following:

    Documentation in the peer reviewed medical literature or other reliable data that there have been changes in physician work due to one or more of the following: technique; knowledge and technology; patient population; site-of-service; length of hospital stay; and work time.

    An anomalous relationship between the code being proposed for review and other codes.

    Evidence that technology has changed physician work, that is, diffusion of technology.

    Analysis of other data on time and effort measures, such as operating room logs or national and other representative databases.

    Evidence that incorrect assumptions were made in the previous valuation of the service, such as a misleading vignette, survey, or flawed crosswalk assumptions in a previous evaluation.

    Prices for certain high cost supplies or other direct PE inputs that are used to determine PE RVUs are inaccurate and do not reflect current information.

    Analyses of work time, work RVU, or direct PE inputs using other data sources (for example, Department of Veteran Affairs (VA) National Surgical Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons (STS) National Database, and the Physician Quality Reporting System (PQRS) databases).

    National surveys of work time and intensity from professional and management societies and organizations, such as hospital associations.

    After we receive the nominated codes during the 60-day comment period following the release of the annual PFS final rule with comment period, we evaluate the supporting documentation and assess whether the nominated codes appear to be potentially misvalued codes appropriate for review under the annual process. In the following year's PFS proposed rule, we publish the list of nominated codes and indicate whether we are proposing each nominated code as a potentially misvalued code.

    During the comment period on the CY 2015 proposed rule and final rule with comment period, we received nominations and supporting documentation for three codes to be considered as potentially misvalued codes. We evaluated the supporting documentation for each nominated code to ascertain whether the submitted information demonstrated that the code should be proposed as potentially misvalued.

    CPT Code 36516 (Therapeutic apheresis; with extracorporeal selective adsorption or selective filtration and plasma reinfusion) was nominated for review as potentially misvalued. The nominator stated that CPT code 36516 is misvalued because of incorrect direct and indirect PE inputs and an incorrect work RVU. Specifically, the nominator stated that the direct supply costs failed to include an $18 disposable bag and the $37 cost for biohazard waste disposal of the post-treatment bag, and the labor costs associated with nursing being inaccurate. The nominator also stated that the overhead expenses associated with this service were unrealistic and that the current work RVU undervalues a physician's time and expertise. We are proposing this code as a potentially misvalued code. We note that we established a policy in CY 2011 to consider biohazard bags as an indirect expense, and not as a direct PE input (75 FR 73192).

    CPT Codes 52441 (Cystourethroscopy with insertion of permanent adjustable transprostatic implant; single implant) and 52442 (Cystourethroscopy with insertion of permanent adjustable transprostatic implant; each additional permanent adjustable transprostatic implant) were nominated for review as potentially misvalued. The nominator stated that the costs of the direct practice expense inputs were inaccurate, including the cost of the implant. We are proposing these codes as potentially misvalued codes.

    b. Electronic Analysis of Implanted Neurostimulator (CPT Codes 95970-

    95982)

    All of the inputs for CPT codes 95971 (Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); simple spinal cord, or peripheral (ie, peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming), 95972 (Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); complex spinal cord, or peripheral (ie, peripheral nerve, sacral nerve, neuromuscular) (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, up to one hour) and 95973 (Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); complex spinal cord, or peripheral (ie, peripheral nerve, sacral nerve, neuromuscular) (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, each additional 30 minutes after first hour (List separately in addition to code for primary procedure)) were reviewed and valued in the CY 2015 final rule with comment period (79 FR 67670). Due to significant time changes in the base codes, we believe the entire family detailed in Table 7 should be considered as potentially misvalued and reviewed in a manner consistent with our review of CPT codes 95971, 95972 and 95973.

    Table 7--Proposed Potentially Misvalued Codes Identified in the

    Electronic Analysis of Implanted Neurostimulator Family

    ------------------------------------------------------------------------

    HCPCS Short descriptor

    ------------------------------------------------------------------------

    95970......................... Analyze neurostim no prog.

    95974......................... Cranial neurostim complex.

    95975......................... Cranial neurostim complex.

    95978......................... Analyze neurostim brain/1h.

    95979......................... Analyz neurostim brain addon.

    95980......................... Io anal gast n-stim init.

    95981......................... Io anal gast n-stim subsq.

    95982......................... Io ga n-stim subsq w/reprog.

    ------------------------------------------------------------------------

    c. Review of High Expenditure Services across Specialties with Medicare Allowed Charges of $10,000,000 or More

    In the CY 2015 PFS rule, we proposed and finalized the high expenditure screen as a tool to identify potentially misvalued codes in the statutory category of ``codes that account for the majority of spending under the PFS.'' We also identified codes through this screen and proposed them as potentially misvalued in the CY 2015 PFS proposed rule (79 FR 40337-40338). However, given the resources required for the revaluation of codes with 10- and 90-day global periods, we did not finalize those codes as potentially misvalued codes in the CY 2015 PFS final rule with comment period. We stated that we would re-run the high expenditure screen at a future date, and subsequently propose the specific set of

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    codes that meet the high expenditure criteria as potentially misvalued codes (79 FR 67578).

    We believe that our current resources will not necessitate further delay in proceeding with the high expenditure screen for CY 2016. We have re-run the screen with the same criteria finalized in last year's rule. However, in developing this year's proposed list, we excluded all codes with 10- and 90-day global periods since we believe these codes should be reviewed as part of the global surgery revaluation. We are proposing the 118 codes listed in Table 8 as potentially misvalued codes, identified using the high expenditure screen under the statutory category, ``codes that account for the majority of spending under the PFS.''

    To develop this list, we followed the same approach taken last year except we excluded 10 and 90- day global periods. Specifically, we identified the top 20 codes by specialty (using the specialties used in Table 45) in terms of allowed charges. As we did last year, we excluded codes that we have reviewed since CY 2010, those with fewer than $10 million in allowed charges, and those that describe anesthesia or E/M services. We excluded E/M services from the list of proposed potentially misvalued codes for the same reasons that we excluded them in a similar review in CY 2012. These reasons were explained in the CY 2012 final rule with comment period (76 FR 73062 through 73065).

    Table 8--Proposed Potentially Misvalued Codes Identified Through High

    Expenditure by Specialty Screen

    ------------------------------------------------------------------------

    HCPCS Short descriptor

    ------------------------------------------------------------------------

    10022......................... Fna w/image

    11100......................... Biopsy skin lesion

    11101......................... Biopsy skin add-on

    11730......................... Removal of nail plate

    20550......................... Inj tendon sheath/ligament

    20552......................... Inj trigger point 1/2 muscl

    20553......................... Inject trigger points 3/>

    22614......................... Spine fusion extra segment

    22840......................... Insert spine fixation device

    22842......................... Insert spine fixation device

    22845......................... Insert spine fixation device

    27370......................... Injection for knee x-ray

    29580......................... Application of paste boot

    31500......................... Insert emergency airway

    31575......................... Diagnostic laryngoscopy

    31579......................... Diagnostic laryngoscopy

    31600......................... Incision of windpipe

    33518......................... Cabg artery-vein two

    36215......................... Place catheter in artery

    36556......................... Insert non-tunnel cv cath

    36569......................... Insert picc cath

    36620......................... Insertion catheter artery

    38221......................... Bone marrow biopsy

    51700......................... Irrigation of bladder

    51702......................... Insert temp bladder cath

    51720......................... Treatment of bladder lesion

    51728......................... Cystometrogram w/vp

    51729......................... Cystometrogram w/vp&up

    51784......................... Anal/urinary muscle study

    51797......................... Intraabdominal pressure test

    51798......................... Us urine capacity measure

    52000......................... Cystoscopy

    55700......................... Biopsy of prostate

    58558......................... Hysteroscopy biopsy

    67820......................... Revise eyelashes

    70491......................... Ct soft tissue neck w/dye

    70543......................... Mri orbt/fac/nck w/o &w/dye

    70544......................... Mr angiography head w/o dye

    70549......................... Mr angiograph neck w/o&w/dye

    71010......................... Chest x-ray 1 view frontal

    71020......................... Chest x-ray 2vw frontal&latl

    71260......................... Ct thorax w/dye

    71270......................... Ct thorax w/o & w/dye

    72195......................... Mri pelvis w/o dye

    72197......................... Mri pelvis w/o & w/dye

    73110......................... X-ray exam of wrist

    73130......................... X-ray exam of hand

    73718......................... Mri lower extremity w/o dye

    73720......................... Mri lwr extremity w/o&w/dye

    74000......................... X-ray exam of abdomen

    74022......................... X-ray exam series abdomen

    74181......................... Mri abdomen w/o dye

    74183......................... Mri abdomen w/o & w/dye

    75635......................... Ct angio abdominal arteries

    75710......................... Artery x-rays arm/leg

    75978......................... Repair venous blockage

    76512......................... Ophth us b w/non-quant a

    76519......................... Echo exam of eye

    76536......................... Us exam of head and neck

    77059......................... Mri both breasts

    77263......................... Radiation therapy planning

    77334......................... Radiation treatment aid(s)

    77470......................... Special radiation treatment

    78306......................... Bone imaging whole body

    78452......................... Ht muscle image spect mult

    88185......................... Flowcytometry/tc add-on

    88189......................... Flowcytometry/read 16 & >

    88321......................... Microslide consultation

    88360......................... Tumor immunohistochem/manual

    88361......................... Tumor immunohistochem/comput

    91110......................... Gi tract capsule endoscopy

    92002......................... Eye exam new patient

    92136......................... Ophthalmic biometry

    92240......................... Icg angiography

    92250......................... Eye exam with photos

    92275......................... Electroretinography

    92557......................... Comprehensive hearing test

    92567......................... Tympanometry

    93280......................... Pm device progr eval dual

    93288......................... Pm device eval in person

    93293......................... Pm phone r-strip device eval

    93294......................... Pm device interrogate remote

    93295......................... Dev interrog remote 1/2/mlt

    93296......................... Pm/icd remote tech serv

    93306......................... Tte w/doppler complete

    93350......................... Stress tte only

    93351......................... Stress tte complete

    93503......................... Insert/place heart catheter

    93613......................... Electrophys map 3d add-on

    93965......................... Extremity study

    94010......................... Breathing capacity test

    94620......................... Pulmonary stress test/simple

    95004......................... Percut allergy skin tests

    95165......................... Antigen therapy services

    95957......................... Eeg digital analysis

    96101......................... Psycho testing by psych/phys

    96116......................... Neurobehavioral status exam

    96118......................... Neuropsych tst by psych/phys

    96360......................... Hydration iv infusion init

    96372......................... Ther/proph/diag inj sc/im

    96374......................... Ther/proph/diag inj iv push

    96375......................... Tx/pro/dx inj new drug addon

    96401......................... Chemo anti-neopl sq/im

    96402......................... Chemo hormon antineopl sq/im

    96409......................... Chemo iv push sngl drug

    96411......................... Chemo iv push addl drug

    96567......................... Photodynamic tx skin

    96910......................... Photochemotherapy with uv-b

    97032......................... Electrical stimulation

    97035......................... Ultrasound therapy

    97110......................... Therapeutic exercises

    97112......................... Neuromuscular reeducation

    97113......................... Aquatic therapy/exercises

    97116......................... Gait training therapy

    97140......................... Manual therapy 1/regions

    97530......................... Therapeutic activities

    97535......................... Self care mngment training

    G0283......................... Elec stim other than wound

    ------------------------------------------------------------------------

    5. Valuing Services That Include Moderate Sedation as an Inherent Part of Furnishing the Procedure

    The CPT manual includes more than 400 diagnostic and therapeutic procedures, listed in Appendix G, for which CPT has determined that moderate sedation is an inherent part of furnishing the procedure. Therefore, only the procedure code is reported when furnishing the service, and in developing RVUs for these services, we include the resource costs associated with moderate sedation in the valuation of these diagnostic and therapeutic procedures. To the extent that moderate sedation is inherent in the diagnostic or therapeutic service, we believe that the inclusion of moderate sedation in the valuation of the procedure is accurate. In the CY 2015 PFS proposed rule (79 FR 40349), we noted that it appeared that practice patterns for endoscopic procedures were changing, with anesthesia increasingly being separately reported for these procedures. Due to the changing nature of medical practice, we noted that we were considering establishing a uniform approach to valuation for all Appendix G services. We continue to seek an approach that is based on using the best available objective information about the provision of moderate sedation broadly, rather than merely addressing this issue on a code-by-code basis using RUC survey data when individual procedures

    Page 41707

    are revalued. We sought public comment on approaches to address the appropriate valuation of these services given that moderate sedation is no longer inherent for many of these services. To the extent that Appendix G procedure values are adjusted to no longer include moderate sedation, we requested suggestions as to how moderate sedation should be reported and valued, and how to remove from existing valuations the RVUs and inputs related to moderate sedation.

    To establish an approach to valuation for all Appendix G services based on the best data about the provision of moderate sedation, we need to determine the extent of the misvaluation for each code. We know that there are standard packages for the direct PE inputs associated with moderate sedation, and we began to develop approaches to estimate how much of the work is attributable to moderate sedation. However, we believe that we should seek input from the medical community prior to proposing changes in values for these services, given the different methodologies used to develop work RVUs for the hundreds of services in Appendix G. Therefore, we are seeking recommendations from the RUC and other interested stakeholders for appropriate valuation of the work associated with moderate sedation before formally proposing an approach that allows Medicare to adjust payments based on the resource costs associated with the moderate sedation or anesthesia services that are being furnished.

    The anesthesia procedure codes 00740 (Anesthesia for procedure on gastrointestinal tract using an endoscope) and 00810 (Anesthesia for procedure on lower intestine using an endoscope) are used for anesthesia furnished in conjunction with lower GI procedures. In reviewing Medicare claims data, we noted that a separate anesthesia service is now reported more than 50 percent of the time that several types of colonoscopy procedures are reported. Given the significant change in the relative frequency with which anesthesia codes are reported with colonoscopy services, we believe the relative values of the anesthesia services should be re-examined. Therefore, we are proposing to identify CPT codes 00740 and 00810 as potentially misvalued. We welcome comments on both of these issues.

    6. Improving the Valuation and Coding of the Global Package

    a. Proposed Transition of 10-Day and 90-Day Global Packages Into 0-Day Global Packages

    In the CY 2015 PFS final rule (79 FR 67582 through 67591) we finalized a policy to transition all 10-day and 90-day global codes to 0-day global codes to improve the accuracy of valuation and payment for the various components of global surgical packages, including pre- and post-operative visits and performance of the surgical procedure. Although we have marginally addressed some of the concerns noted with global packages in previous rulemaking, we believe there is still an unmet need to address some of the fundamental issues with the 10- and 90-day post-operative global packages. We believe it is critical that the RVUs used to develop PFS payment rates reflect the most accurate resource costs associated with PFS services. We believe that valuing global codes that package services together without objective, auditable data on the resource costs associated with the components of the services contained in the packages may significantly skew relativity and create unwarranted payment disparities within PFS fee-

    for-service payment. We also believe that the resource based valuation of individual physicians' services will continue to serve as a critical foundation for Medicare payment to physicians. Therefore, we believe it is critical that the RVUs under the PFS be based as closely and accurately as possible on the actual resources involved in furnishing the typical occurrence of specific services.

    We stated our belief that transforming all 10- and 90-day global codes to 0-day global codes would:

    Increase the accuracy of PFS payment by setting payment rates for individual services based more closely upon the typical resources used in furnishing the procedures;

    Avoid potentially duplicative or unwarranted payments when a beneficiary receives post-operative care from a different practitioner during the global period;

    Eliminate disparities between the payment for E/M services in global periods and those furnished individually;

    Maintain the same-day packaging of pre- and post-operative physicians' services in the 0-day global; and

    Facilitate availability of more accurate data for new payment models and quality research.

    b. Impact of the Medicare Access and CHIP Reauthorization Act of 2015

    The Medicare Access and CHIP Reauthorization Act (MACRA) was enacted into law on April 16, 2015. Section 523 of the MACRA addresses payment for global surgical packages. Section 523(a) adds a new paragraph at section 1848(c)(8) of the Act. Section 1848(c)(8)(A)(i) of the Act prohibits the Secretary from implementing the policy established in the CY 2015 PFS final rule with comment period that would have transitioned all 10-day and 90-day global surgery packages to 0-day global periods. Section 1848(c)(8)(A)(ii) of the Act provides that nothing in the previous clause shall be construed to prevent the Secretary from revaluing misvalued codes for specific surgical services or assigning values to new or revised codes for surgical services.

    Section 1848(c)(8)(B)(i) of the Act requires CMS to develop through rulemaking a process to gather information needed to value surgical services from a representative sample of physicians, and requires that the data collection shall begin no later than January 1, 2017. The collected information must include the number and level of medical visits furnished during the global period and other items and services related to the surgery, as appropriate. This information must be reported on claims at the end of the global period or in another manner specified by the Secretary. Section 1848(c)(8)(B)(ii) of the Act requires that, every 4 years, we must reassess the value of this collected information, and allows us to discontinue the collection if the Secretary determines that we have adequate information from other sources in order to accurately value global surgical services. Section 1848(c)(8)(B)(iii) of the Act specifies that the Inspector General will audit a sample of the collected information to verify its accuracy. Section 1848(c)(8)(C) of the Act requires that, beginning in CY 2019, we must use the information collected as appropriate, along with other available data, to improve the accuracy of valuation of surgical services under the PFS. Section 523(b) of the MACRA adds a new paragraph at section 1848(c)(9) of the Act which authorizes the Secretary, through rulemaking, to delay up to 5 percent of the PFS payment for services for which a physician is required to report information under section 1848(c)(8)(B)(i) of the Act until the required information is reported.

    Since section 1848(c)(8)(B)(i) of the Act, as added by section 523(a) of the MACRA, requires us to use rulemaking

    Page 41708

    to develop and implement the process to gather information needed to value surgical services no later than January 1, 2017, we are seeking input from stakeholders on various aspects of this task. We are soliciting comments from the public regarding the kinds of auditable, objective data (including the number and type of visits and other services furnished by the practitioner reporting the procedure code during the current post-operative periods) needed to increase the accuracy of the values for surgical services. We are also seeking comment on the most efficient means of acquiring these data as accurately and efficiently as possible. For example, we seek information on the extent to which individual practitioners or practices may currently maintain their own data on services, including those furnished during the post-operative period, and how we might collect and objectively evaluate those data for use in increasing the accuracy of the values beginning in CY 2019. We will use the information from the public comments to help develop a proposed approach for the collection of this information in future rulemaking.

    Section 1848(c)(8)(C) of the Act mandates that we use the collected data to improve the accuracy of valuation of surgery services beginning in 2019. We described in previous rulemaking (79 FR 67582 through 67591) the limitations and difficulties involved in the appropriate valuation of the global packages, especially when the values of the component services are not clear. We are seeking public comment on potential methods of valuing the individual components of the global surgical package, including the procedure itself, and the pre- and post-operative care, including the follow-up care during post-operative days. We are particularly interested in stakeholder input regarding the overall accuracy of the values and descriptions of the component services within the global packages. For example, we seek information from stakeholders on whether (both qualitatively and quantitatively) postoperative visits differ from other E/M services. We are also interested in stakeholder input on what other items and services related to the surgery, aside from postoperative visits, are furnished to beneficiaries during post-operative care. We believe that stakeholder input regarding these questions will help determine what data should be collected, as well as how to improve the accuracy of the valuations. We welcome the full range of public feedback from stakeholders to assist us in this process.

    We intend to provide further opportunities for public feedback prior to developing a proposal for CY 2017 to collect this required data. We also seek comments regarding stakeholder interest in the potential for an open door forum, town hall meetings with the public, or other avenues for direct communication regarding implementation of these provisions of the Act.

  32. Refinement Panel

    1. Background

    As discussed in the CY 1993 PFS final rule with comment period (57 FR 55938), we adopted a refinement panel process to assist us in reviewing the public comments on CPT codes with interim final work RVUs for a year and in developing final work values for the subsequent year. We decided the panel would be composed of a multispecialty group of physicians who would review and discuss the work involved in each procedure under review, and then each panel member would individually rate the work of the procedure. We believed establishing the panel with a multispecialty group would balance the interests of the specialty societies who commented on the work RVUs with the budgetary and redistributive effects that could occur if we accepted extensive increases in work RVUs across a broad range of services.

    Following enactment of section 1848(c)(2)(K) of the Act, which required the Secretary periodically to identify and review potentially misvalued codes and make appropriate adjustments to the RVUs, we reassessed the refinement panel process. As detailed in the CY 2011 PFS final rule with comment period (75 FR 73306), we continued using the established refinement panel process with some modifications.

    For CY 2015, in light of the changes we made to the process for valuing new, revised and potentially misvalued codes (79 FR 67606), we reassessed the role that the refinement panel process plays in the code valuation process. We noted that the current refinement panel process is tied to the review of interim final values. It provides an opportunity for stakeholders to provide new clinical information that was not available at the time of the RUC valuation that might affect work RVU values that are adopted in the interim final value process. For CY 2015 interim final rates, we stated in the CY 2015 PFS final rule with comment period that we will use the refinement panel process as usual for these codes (79 FR 67609).

    2. CY 2016 Refinement Panel Proposal

    Beginning in CY 2016, we are proposing to permanently eliminate the refinement panel and instead publish the proposed rates for all interim final codes in the PFS proposed rule for the subsequent year. For example, we will publish the proposed rates for all CY 2016 interim final codes in the CY 2017 PFS proposed rule. With the change in the process for valuing codes adopted in the CY 2015 final rule with comment period (79 FR 67606), proposed values for most codes that are being valued for CY 2016 will be published in the CY 2016 PFS proposed rule. As explained in the CY 2015 final rule with comment period, only a small number of codes being valued for CY 2016 will be published as interim final in the 2016 PFS final rule with comment period and be subject to comment. We will evaluate the comments we receive on these code values, and both respond to these comments and propose values for these codes for CY 2017 in the CY 2017 PFS proposed rule. Therefore, stakeholders will have two opportunities to comment and to provide any new clinical information that was not available at the time of the RUC valuation that might affect work RVU values that are adopted on an interim final basis. We believe that this proposed process, which includes two opportunities for public notice and comment, offers stakeholders a better mechanism and ample opportunity for providing any additional data for our consideration, and discussing any concerns with our interim final values, than the current refinement process. It also provides greater transparency because comments on our rules are made available to the public at www.regulations.gov. We welcome comments on this proposed change to eliminate the use of refinement panels in our process for establishing final values for interim final codes.

  33. Improving Payment Accuracy for Primary Care and Care Management Services

    We are committed to supporting primary care, and we have increasingly recognized care management as one of the critical components of primary care that contributes to better health for individuals and reduced expenditure growth (77 FR 68978). Accordingly, we have prioritized the development and implementation of a series of initiatives designed to improve the accuracy of payment for, and encourage long-term investment in, care management services.

    Page 41709

    In addition to the Medicare Shared Savings Program, various demonstration initiatives including the Pioneer Accountable Care Organization (ACO), the patient-centered medical home model in the Multi-payer Advanced Primary Care Practice (MAPCP), the Federally Qualified Health Center (FQHC) Advanced Primary Care Practice demonstration, the Comprehensive Primary Care (CPC) initiative, among others (see the CY 2015 PFS final rule (79 FR 67715) for a discussion of these), we also have continued to explore potential refinements to the PFS that would appropriately value care management within Medicare's statutory structure for fee-for-service physician payment and quality reporting. The payment for some non-face-to-face care management services is bundled into the payment for face-to-face evaluation and management (E/M) visits. However, because the current E/

    M office/outpatient visit CPT codes were designed with an overall orientation toward episodic treatment, we have recognized that these E/

    M codes may not reflect all the services and resources involved with furnishing certain kinds of care, particularly comprehensive, coordinated care management for certain categories of beneficiaries.

    Over several years, we have developed proposals and sought stakeholder input regarding potential PFS refinements to improve the accuracy of payment for care management services. For example, in the CY 2013 PFS final rule with comment period, we adopted a policy to pay separately for transitional care management (TCM) involving the transition of a beneficiary from care furnished by a treating physician during an inpatient stay to care furnished by the beneficiary's primary physician in the community (77 FR 68978 through 68993). In the CY 2014 PFS final rule with comment period, we finalized a policy, beginning in CY 2015 (78 FR 74414), to pay separately for chronic care management (CCM) services furnished to Medicare beneficiaries with two or more chronic conditions. We believe that these new separately billable codes more accurately describe, recognize, and make payment for non-face-to-

    face care management services furnished by practitioners and clinical staff to particular patient populations.

    We view ongoing refinements to payment for care management services as part of a broader strategy to incorporate input and information gathered from research, initiatives, and demonstrations conducted by CMS and other public and private stakeholders, the work of all parties involved in the potentially misvalued code initiative, and, more generally, from the public at large. Based on input and information gathered from these sources, we are considering several potential refinements that would continue our efforts to improve the accuracy of PFS payments. In this section, we discuss these potential refinements.

    1. Improved Payment for the Professional Work of Care Management Services

    Although both the TCM and CCM services describe certain aspects of professional work, some stakeholders have suggested that neither of these new sets of codes nor the inputs used in their valuations explicitly account for all of the services and resources associated with the more extensive cognitive work that primary care physicians and other practitioners perform in planning and thinking critically about the individual chronic care needs of particular subsets of Medicare beneficiaries. Stakeholders assert that the time and intensity of the cognitive efforts are in addition to the work typically required to supervise and manage the clinical staff associated with the current TCM and CCM codes. Similarly, we continue to receive requests from a few stakeholders for CMS to lead efforts to revise the current CPT E/M codes or construct a new set of E/M codes. The goal of such efforts would be to better describe and value the physician work (time and intensity) specific to primary care and other cognitive specialties in the context of complex care of patients relative to the time and intensity of the procedure-oriented care physicians and practitioners, who use the same codes to report E/M services. Some of these stakeholders have suggested that in current medical practice, many physicians, in addition to the time spent treating acute illnesses, spend substantial time working toward optimal outcomes for patients with chronic conditions and patients they treat episodically, which can involve additional work not reflected in the codes that describe E/M services since that work is not typical across the wide range of practitioners that report the same codes. According to these groups, this work involves medication reconciliation, the assessment and integration of numerous data points, effective coordination of care among multiple other clinicians, collaboration with team members, continuous development and modification of care plans, patient or caregiver education, and the communication of test results.

    We agree with stakeholders that it is important for Medicare to use codes that accurately describe the services furnished to Medicare beneficiaries and to accurately reflect the relative resources involved with furnishing those services. Therefore, we are interested in receiving public comments on ways to recognize the different resources (particularly in cognitive work) involved in delivering broad-based, ongoing treatment, beyond those resources already incorporated in the codes that describe the broader range of E/M services. The resource costs of this work may include the time and intensity related to the management of both long-term and, in some cases, episodic conditions. In order to appropriately recognize the different resource costs for this additional cognitive work within the structure of PFS resource-

    based payments, we are particularly interested in codes that could be used in addition to, not instead of, the current E/M codes.

    In principle, these codes could be similar to the hundreds of existing add-on codes that describe additional resource costs, such as additional blocks or slides in pathology services, additional units of repair in dermatologic procedures, or additional complexity in psychotherapy services. For example, these codes might allow for the reporting of the additional time and intensity of the cognitive work often undertaken by primary care and other cognitive specialties in conjunction with an evaluation and management service, much like add-on codes for certain procedures or diagnostic test describe the additional resources sometimes involved in furnishing those services. Similar to the CCM code, the codes might describe the increased resources used over a longer period of time than during one patient visit. For example, the add-on codes could describe the professional time in excess of 30 minutes and/or a certain set of furnished services, per one calendar month for a single patient to coordinate care, provide patient or caregiver education, reconcile and manage medications, assess and integrate data, or develop and modify care plans. Such activity may be particularly relevant for the care of patients with multiple or complicated chronic or acute conditions and should contribute to optimal patient outcomes, including more coordinated, safer care.

    Like CCM, we would require that the patient have an established relationship with the billing professional; and additionally, the use of an add-on code would require the extended professional resources to be reported with another

    Page 41710

    separately payable service. However, in contrast to the CCM code, the new codes might be reported based on the resources involved in professional work, instead of the resource costs in terms of clinical staff time. The codes might also apply broadly to patients in a number of different circumstances, and would not necessarily make reporting the code(s) contingent on particular business models or technologies for medical practices. We are interested in stakeholder comments on the kinds of services that involve the type of cognitive work described above and whether or not the creation of particular codes might improve the accuracy of the relative values used for such services on the PFS. Finally, we are interested in receiving information from stakeholders on the overlap between the kinds of cognitive resource costs discussed above and those already accounted for through the currently payable codes that describe CCM and other care management services.

    We strongly encourage stakeholders to comment on this topic in order to assist us in developing potential proposals to address these issues through rulemaking in CY 2016 for implementation in CY 2017. We anticipate using this approach, which would parallel our multi-year approach for implementing CCM and TCM services, in order to facilitate broader input from stakeholders regarding details of implementing such codes, including their structure and description, valuation, and any requirements for reporting.

    2. Establishing Separate Payment for Collaborative Care

    We believe that the care and management for Medicare beneficiaries with multiple chronic conditions, a particularly complicated disease or acute condition, or common behavioral health conditions often requires extensive discussion, information-sharing and planning between a primary care physician and a specialist (for example, with a neurologist for a patient with Alzheimer's disease plus other chronic diseases). We note that for CY 2014, CPT created four codes that describe interprofessional telephone/internet consultative services (CPT codes 99446-99449). Because Medicare pays for telephone consultations with or about a beneficiary as a part of other services furnished to the beneficiary, we currently do not make separate payment for these services. We note that such interprofessional consultative services are distinct from the face-to-face visits previously reported to Medicare using the consultation codes, and we refer the reader to the CY 2010 PFS final rule for information regarding Medicare payment policies for those services (74 FR 61767).

    However, in considering how to improve the accuracy of our payments for care coordination particularly for patients requiring more extensive care, we are seeking comment on how Medicare might accurately account for the resource costs of a more robust interprofessional consultation within the current structure of PFS payment. For example, we would be interested in stakeholders' perspectives regarding whether there are conditions under which it might be appropriate to make separate payment for services like those described by these CPT codes. We are interested in stakeholder input regarding the parameters of, and resources involved in these collaborations between a specialist and primary care practitioner, especially in the context of the structure and valuation of current E/M services. In particular, we are interested in comments about how these collaborations could be distinguished from the kind of services included in other E/M services, how these services could be described if stakeholders believe the current CPT codes are not adequate, and how these services should be valued on the PFS. We are also interested in comments on whether we should tie those interprofessional consultations to a beneficiary encounter and on developing appropriate beneficiary protections to ensure that beneficiaries are fully aware of the involvement of the specialist in the beneficiary's care and the associated benefits of the collaboration between the primary care physician and the specialist physician prior to being billed for such services.

    Additionally, we are seeking comment on whether this kind of care might benefit from inclusion in a CMMI model that would allow Medicare to test its effectiveness with a waiver of beneficiary financial liability and/or variation of payment amounts for the consulting and the primary care practitioners. Without such protections, beneficiaries could be responsible for coinsurance for services of physicians whose role in the beneficiary's care is not necessarily understood by the beneficiary. Finally, we also are seeking comment on key technology supports needed to support collaboration between specialist and primary care practitioners in support of high quality care management services, on whether we should consider including technology requirements as part of any proposed services, and on how such requirements could be implemented in a way that minimizes burden on providers. We strongly encourage stakeholders to comment on this topic in order to assist us in developing potential proposals to address these issues through rulemaking in CY 2016 for implementation in CY 2017. We anticipate using this approach, which would parallel our multi-year approach for implementing CCM and TCM services, in order to facilitate broader input from stakeholders regarding details of implementing such codes, including their structure and description, valuation, and any requirements for reporting.

    a. Collaborative Care Models for Beneficiaries With Common Behavioral Health Conditions

    In recent years, many randomized controlled trials have established an evidence base for an approach to caring for patients with common behavioral health conditions called ``Collaborative Care.'' Collaborative care typically is provided by a primary care team, consisting of a primary care provider and a care manager, who works in collaboration with a psychiatric consultant, such as a psychiatrist. Care is directed by the primary care team and includes structured care management with regular assessments of clinical status using validated tools and modification of treatment as appropriate. The psychiatric consultant provides regular consultations to the primary care team to review the clinical status and care of patients and to make recommendations. Several resources have been published that describe collaborative care models in greater detail and assess their impact, including pieces from the University of Washington (http://aims.uw.edu/

    ), the Institute for Clinical and Economic Review (http://ctaf.org/reports/integration-behavioral-health-primary-care), and the Cochrane Collaboration (http://www.cochrane.org/CD006525/DEPRESSN_collaborative-care-for-people-with-depression-and-anxiety).

    Because this particular kind of collaborative care model has been tested and documented in medical literature, we are particularly interested in seeking comment on how coding under the PFS might facilitate appropriate valuation of the services furnished under such a collaborative care model. As these kinds of collaborative models of care become more prevalent, we will evaluate potential refinements to the PFS to account for the provision of services through such a model. We are seeking information to assist us in considering refinements to coding and payment to

    Page 41711

    address this model in particular. We also would assess application of the collaborative care model for other diagnoses and treatment modalities. For example, we seek comments on how a code similar to the CCM code applicable to multiple diagnoses and treatment plans could be used to describe collaborative care services, as well as other interprofessional services and could be appropriately valued and reported within the resource-based relative value PFS system, and how the resources involved in furnishing such services could be incorporated into the current set of PFS codes without overlap. We also request input on whether requirements similar to those used for CCM services should apply to a new collaborative care code, and whether such a code could be reported in conjunction with CCM or other E/M services. For example, we might consider whether the code should describe a minimum amount of time spent by the psychiatric consultant for a particular patient per one calendar month and be complemented by either the CCM or other care management code to support the care management and primary care elements of the collaborative care model. As with our discussion on interprofessional consultation in this section of the proposed rule, because the patient may not have direct contact with the psychiatric consultant, we seek comment on whether and, if so, how written consent for the non-face-to-face services should be required prior to practitioners reporting any new interprofessional consultation code or the care management code.

    We are also seeking comment on appropriate care delivery requirements for billing, the appropriateness of CCM technology requirements or other technology requirements for these services, necessary qualifications for psychiatric consultants, and whether or not there are particular conditions for which payment would be more appropriate than others; as well as how these services may interact with quality reporting, the resource inputs we might use to value the services under the PFS (specifically, work RVUs, time, and direct PE inputs), and whether or not separate codes should be developed for the psychiatric consultant and the care management components of the service.

    We are also seeking comment on whether this kind of care model should be implemented through a CMMI demonstration that would allow Medicare to test its effectiveness with a waiver of beneficiary financial liability and/or variation of payment methodology and amounts for the psychiatric consultant and the primary care physician. Again, we strongly encourage stakeholders to comment on this topic in order to assist us in developing potential proposals to address these issues through rulemaking in CY 2016 for implementation in CY 2017.

    3. CCM and TCM Services

    a. Reducing Administrative Burden for CCM and TCM Services

    In CY 2013, we implemented separate payment for TCM services, and in CY 2015, we implemented separate payment for CCM services. Both have many service elements and billing requirements that the physician or nonphysician practitioner must satisfy in order to fully furnish these services and to report these codes (77 FR 68989, 79 FR 67728). These elements and requirements are relatively extensive and generally exceed those for other E/M and similar services. Since the implementation of these services, some practitioners have stated that the service elements and billing requirements are too burdensome, and suggested that they interfere with their ability to provide these care management services to their patients who could benefit from them. In light of this feedback from the physician and practitioner community, we are soliciting comments on steps that we could take to further improve beneficiary access to TCM and CCM services. Our aims in implementing separate payment for these services are that Medicare practitioners are paid appropriately for the services they furnish, and that beneficiaries receive comprehensive care management that benefits their long term health outcomes. However, we understand that excessive requirements on practitioners could possibly undermine the overall goals of the payment policies. We are interested in stakeholder input in how we can best balance access to these services and practitioner burdens such that Medicare beneficiaries may obtain the full benefit of these services.

    b. Payment for CPT Codes Related to CCM Services

    As we stated in the CY 2015 PFS final rule (79 FR 67719), we believe that Medicare beneficiaries with two or more chronic conditions as defined under the CCM code can benefit from the care management services described by that code, and we want to make this service available to all such beneficiaries. As with most services paid under the PFS, we recognize that furnishing CCM services to some beneficiaries will require more resources and some less; but we value and make payment based upon the typical service. Because CY 2015 is the first year for which we are making separate payment for CCM services, we are seeking information regarding the circumstances under which this service is furnished. This information includes the clinical status of the beneficiaries receiving the service and the resources involved in furnishing the service, such as the number of documented non-face-to-

    face minutes furnished by clinical staff in the months the code is reported. We would be interested in examining such information in order to identify the range of minutes furnished over those months as well as the distribution of the number of minutes within the total volume of services. We are also seeking objective data regarding the resource costs associated with furnishing the services described by this code. As we review that information, in addition to our own claims data, we will consider any changes in payment and coding that may be warranted in the coming years, including the possibility of establishing separate payment amounts and making Medicare payment for the related CPT codes, such as the complex care coordination codes, CPT codes 99487 and 99489.

  34. Target for Relative Value Adjustments for Misvalued Services

    Section 220(d) of the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93, enacted on April 1, 2014) added a new subparagraph at section 1848(c)(2) of the Act to establish an annual target for reductions in PFS expenditures resulting from adjustments to relative values of misvalued codes. Under section 1848(c)(2)(O)(ii) of the Act, if the estimated net reduction in expenditures for a year is equal to or greater than the target for the year, reduced expenditures attributable to such adjustments shall be redistributed in a budget-

    neutral manner within the PFS in accordance with the existing budget neutrality requirement under section 1848(c)(2)(B)(ii)(II) of the Act. The provision also specifies that the amount by which such reduced expenditures exceeds the target for a given year shall be treated as a net reduction in expenditures for the succeeding year, for purposes of determining whether the target has been met for that subsequent year. Section 1848(c)(2)(O)(iv) of the Act defines a target recapture amount as the amount by which the target for the year exceeds the estimated net reduction in expenditures under the PFS resulting from adjustments to RVUs for misvalued codes. Section 1848(c)(2)(O)(iii) of the

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    Act specifies that, if the estimated net reduction in PFS expenditures for the year is less than the target for the year, an amount equal to the target recapture amount shall not be taken into account when applying the budget neutrality requirements specified in section 1848(c)(2)(B)(ii)(II) of the Act. Section 220(d) of the PAMA applied to calendar years (CYs) 2017 through 2020 and set the target under section 1848(c)(2)(O)(v) of the Act at 0.5 percent of the estimated amount of expenditures under the PFS for each of those 4 years.

    Section 202 of the Achieving a Better Life Experience Act of 2014 (ABLE) (Division B of Pub. L. 113-295, enacted December 19, 2014)) amended section 1848(c)(2)(O) of the Act to accelerate the application of the PFS expenditure reduction target to CYs 2016, 2017, and 2018, and to set a 1 percent target for CY 2016 and 0.5 percent for CYs 2017 and 2018. As a result of these provisions, if the estimated net reduction for a given year is less than the target for that year, payments under the fee schedule will be reduced.

    In this section, we are proposing a methodology to implement this statutory provision in a manner consistent with the broader statutory construct of the PFS. In developing this proposed methodology, we have identified several aspects of our approach for which we are specifically seeking comment. We have organized this discussion by identifying and explaining these aspects in particular but we are seeking comment on all aspects of our proposal.

    1. Distinguishing ``Misvalued Code'' Adjustments From Other RVU Adjustments

    The potentially misvalued code initiative has resulted in changes in PFS payments in several ways. First, potentially misvalued codes have been identified, reviewed, and revalued through notice and comment rulemaking. However, in many cases, the identification of particular codes as potentially misvalued has led to the review and revaluation of related codes, and frequently, to revisions to the underlying coding for large sets of related services. Similarly, the review of individual codes has initiated reviews and proposals to make broader adjustments to values for codes across the PFS, such as when the review of a series of imaging codes prompted a RUC recommendation and CMS proposal to update the direct PE inputs for imaging services to assume digital instead of film costs. This change, originating through the misvalued code initiative, resulted in a significant reduction in RVUs for a large set of PFS services, even though the majority of affected codes were not initially identified through potentially misvalued code screens. Finally, due to both the relativity inherent in the PFS ratesetting process and the budget neutrality requirements specified in section 1848(c)(2)(B)(ii)(II) of the Act, adjustments to the RVUs for individual services necessarily result in the shifting of RVUs to broad sets of other services across the PFS.

    To implement the PFS expenditure reduction target provisions under section 1848(c)(2)(O) of the Act, we must identify a subset of the adjustments in RVUs for a year to reflect an estimated ``net reduction'' in expenditures. Therefore, we dismissed the possibility of including all changes in RVUs for a year in calculating the estimated net reduction in PFS expenditures, even though we believe that the redistributions in RVUs to other services are an important aspect of the potentially misvalued code initiative. Conversely, we similarly considered the possibility of limiting the calculation of the estimated net reduction in expenditures to reflect RVU adjustments made to the codes formally identified as ``potentially misvalued.'' We do not believe that calculation would reflect the significant changes in payments that have directly resulted from the review and revaluation of misvalued codes under section 1848(c)(2) of the Act. We further considered whether to include only those codes that underwent a comprehensive review (work and PE). As we previously have stated (76 FR 73057), we believe that a comprehensive review of the work and PE for each code leads to the more accurate assignment of RVUs and appropriate payments under the PFS than do fragmentary adjustments for only one component. However, if we calculated the net reduction in expenditures using revisions to RVUs only from comprehensive reviews, the calculation would not include changes in PE RVUs that result from proposals like the film-to-digital change for imaging services, which not only originated from the review of potentially misvalued codes, but substantially improved the accuracy of PFS payments faster and more efficiently than could have been done through the multiple-year process required to complete a comprehensive review of all imaging codes.

    After considering these options, we believe that the best approach is to define the reduction in expenditures as a result of adjustments to RVUs for misvalued codes to include the estimated pool of all services with revised input values. This would limit the pool of RVU adjustments used to calculate the net reduction in expenditures to those for the services for which individual, comprehensive review or broader proposed adjustments have resulted in changes to service-level inputs of work RVUs, direct PE inputs, or MP RVUs, as well as services directly affected by changes to coding for related services. For example, coding changes in certain codes can sometimes necessitate revaluations for related codes that have not been reviewed as misvalued codes, because the coding changes have also affected the scope of the related services. This definition would incorporate all reduced expenditures from revaluations for services that are deliberately addressed as potentially misvalued codes, as well as those for services with broad-based adjustments like film-to-digital and services that are redefined through coding changes as a result of the review of misvalued codes.

    Because the annual target is calculated by measuring changes from one year to the next, we also considered how to account for changes in values that are best measured over 3 years, instead of 2 years. Under our current process, the overall change in valuation for many misvalued codes is measured across values for 3 years: The original value in the first year, the interim final value in the second year, and the finalized value in the third year. As we describe in section II.I.2. of this proposed rule, our misvalued code process has been to establish interim final RVUs for the potentially misvalued, new, and revised codes in the final rule with comment period for a year. Then, during the 60-day period following the publication of the final rule with comment period, we accept public comment about those valuations. For the final rule with comment period for the subsequent year, we consider and respond to public comments received on the interim final values, and make any appropriate adjustments to values based on those comments. However, the straightforward calculation of the target would only compare changes between 2 years and not among 3 years, so the contribution of a particular change towards the target for any single year would be measured against only the preceding year without regard to the overall change that takes place over 3 years.

    For recent years, interim final values for misvalued codes (year 2) have generally reflected reductions relative to original values (year 1), and for most codes, the interim final values (year 2) are maintained and finalized (year 3). However, when values for particular

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    codes have changed between the interim final (year 2) and final values (year 3) based on public comment, the general tendency has been that codes increase in the final value (year 3) relative to the interim final value (year 2), even in cases where the final value (year 3) represents a decrease from the original value (year 1). Therefore, for these codes, the year 2 changes compared to year 1 would risk over-

    representing the overall reduction, while the year 3 to year 2 changes would represent an increase in value. If there were similar targets in every PFS year, and a similar number of misvalued code changes made on an interim final basis, the incongruence in measuring what is really a 3-year change in 2-year increments might not be particularly problematic since each year's calculation would presumably include a similar number of codes measured between years 1 and 2 and years 2 and 3.

    However, including changes that take place over 3 years is particularly problematic for calculating the target for CY 2016 for two reasons. First, CY 2015 was the final full year of establishing interim final values for all new, revised, and potentially misvalued codes. Starting with this proposed rule, we are proposing and finalizing values for a significant portion of misvalued codes during one calendar year. Therefore, CY 2015 will include a disproportionate number of services that would be measured between years 2 and 3 relative to the services measured between 1 and 2 years. Second, because there was no target for CY 2015, any reductions that occurred on an interim final basis for CY 2015 were not counted toward achievement of a target. If we were to include any upward adjustments made to these codes based on public comment as ``misvalued code'' changes for CY 2016, we would effectively be counting the service-level increases for 2016 (year 3) relative to 2015 (year 2) against achievement of the target without any consideration to the service-level changes relative to 2014 (year 1), even in cases where the overall change in valuation was negative.

    Therefore, we are proposing to exclude code-level input changes for CY 2015 interim final values from the calculation of the CY 2016 misvalued code target since the misvalued change occurred over multiple years, including years not applicable to the misvalued code target provision.

    We note that the impact of interim final values in the calculation of targets for future years will be diminished as we transition to proposing values for almost all new, revised, and potentially misvalued codes in the proposed rule. We anticipate a smaller number of interim final values for CY 2016 relative to CY 2015. For calculation of the CY 2018 target, we anticipate almost no impact based on misvalued code adjustments that occur over multiple years.

    The list of codes with proposed changes for CY 2016 included under this proposed definition of ``adjustments to RVUs for misvalued codes'' is available on the CMS Web site under downloads for the CY 2016 PFS proposed rule with comment period at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.

    2. Calculating ``Net Reduction''

    Once the RVU changes attributable to misvalued codes are identified, estimated net reductions would be calculated summing the decreases and offsetting any applicable increases in valuation within the changes defined as misvalued, as described above. Because the provision only explicitly addresses reductions, and we recognize many stakeholders will want to maximize the overall magnitude of the measured reductions in order to prevent an overall reduction to the PFS conversion factor, we considered the possibility of ignoring the applicable increases in valuation in the calculation of net reduction. However, we believe that the requirement to calculate ``net'' reductions implies that we are to take into consideration both decreases and increases. Additionally, we believe this approach may be the only practical one due to the presence of new and deleted codes on an annual basis.

    For example, a service that is described by a single code in a given year, like intensity-modulated radiation therapy (IMRT) treatment delivery, could be addressed as a misvalued service in a subsequent year through a coding revision that splits the service into two codes, ``simple'' and ``complex.'' If we counted only the reductions in RVUs, we would count only the change in value between the single code and the new code that describes the ``simple'' treatment delivery code. In this scenario, the change in value from the single code to the new ``complex'' treatment delivery code would be ignored, so that even if there were an increase in the payment for IMRT treatment delivery service(s) overall, the mere change in coding would contribute inappropriately to a ``net reduction in expenditures.'' Therefore, we are proposing to net the increases and decreases in values for services, including those for which there are coding revisions, in calculating the estimated net reduction in expenditures as a result of adjustments to RVUs for misvalued codes.

    3. Measuring the Adjustments

    The most straightforward method to estimating the net reduction in expenditures due to adjustments to RVUs for misvalued codes is to compare the total RVUs of the relevant set of codes (by volume) in the current year to the update year, and divide that by the total RVUs for all codes (by volume) for the current year. This approach is intuitive and relatively easy to replicate.

    However, this method is imprecise for several reasons. First, and most significantly, the code-level PE RVUs in the update year include either increases due to the redistribution of RVUs from other services or reductions due to increases in PE for other services. Second, because relativity for work RVUs is maintained through annual adjustments to the CF, the precise value of a work RVU in any given year is adjusted based on the total number of work RVUs in that year. Finally, relativity for the MP RVUs is maintained by both redistribution of MP RVUs and adjustments to the CF, when necessary (under our proposed methodology this is true annually; based on our established methodology the redistribution of the MP RVUs only takes place once every 5 years and the CF is adjusted otherwise). Therefore, to make a more precise assessment of the net reduction in expenditures that are the result of adjustments to the RVUs for misvalued codes, we would need to compare, for the included codes, the update year's total work RVUs (by volume), direct PE RVUs (by volume), indirect PE RVUs (by volume), and MP RVUs (by volume) to the same RVUs in the current year, prior to the application of any scaling factors or adjustments. This would make for a direct comparison between years.

    However, this approach would mean that the calculation of the net reduction in expenditures would occur within various steps of the PFS ratesetting methodology. While we believe that this approach would be transparent and external stakeholders could replicate this method, it may be difficult and time-consuming for stakeholders to do so. We also noted that when we modeled the interaction of the phase-in legislation and the calculation of the target using this approach during the development of this proposal, there were methodological challenges in making these calculations. When we simulated the two approaches using

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    information from prior PFS years, we found that both approaches generally resulted in similar estimated net reductions. After considering these options, we are proposing to use the approach of comparing the total RVUs (by volume) for the relevant set of codes in the current year to the update year, and divide that result by the total RVUs (by volume) for the current year. We seek comment on whether comparing the update year's work RVUs, direct PE RVUs, indirect PE RVUs, and MP RVUs for the relevant set of codes (by volume) prior to the application of any scaling factors or adjustments to those of the current year would be a preferable methodology for determining the estimated net reduction.

    4. Estimating the Target for CY 2016

    CY 2016 represents a transition year in our new process of proposing values for new, revised and misvalued codes in the proposed rule, rather than establishing them as interim final in the final rule with comment period. For CY 2016, we will propose values for which we had the RUC's recommendations by our deadline of February 10th, and will establish interim final values for any codes received after the February 10th deadline but in time for us to value for the final rule. For CY 2016, there will still be a significant number of codes valued not in the proposed rule but in the final rule with comment period. In future years (with the exception of entirely new services), all codes, even those for which we do not receive RUC recommendations in time for the proposed rule, will be in the proposed rule for the subsequent year and not in the final rule with comment period. Therefore, for CY 2016, unlike for the targets for CY 2017 and CY 2018, because we will not be able to calculate a realistic estimate of the target amount at the time the proposed rule is published, we will not incorporate the impact of the target into the calculation of the proposed PFS payment rates. However, because we would apply any required budget neutrality adjustment related to this provision to the conversion factor, the proposed RVUs for individual services in this proposed rule would be the same, regardless of the estimate of the target. We also refer readers to the regulatory impact analysis section of this proposed rule for an interim estimate of the estimated net reduction in expenditures relative to the 1 percent target for CY 2016, based solely on the proposed changes in this rule.

  35. Phase-in of Significant RVU Reductions

    Section 1848(c)(7) of the Act, as added by section 220(e) of the PAMA, also specifies that for services that are not new or revised codes, if the total RVUs for a service for a year would otherwise be decreased by an estimated 20 percent or more as compared to the total RVUs for the previous year, the applicable adjustments in work, PE, and MP RVUs shall be phased-in over a 2-year period. Although section 220(e) of the PAMA required the phase-in to begin for 2017, section 202 of the ABLE Act amended section 1848(c)(7) of the Act to require that the phase-in begin for CY 2016.

    In this section, we are proposing a methodology to implement this statutory provision. In developing this proposed methodology, we have identified several aspects of our approach for which we are specifically seeking comment, given the challenges inherent in implementing this provision in a manner consistent with the broader statutory construct of the PFS. We have organized this discussion by identifying and explaining these aspects in particular but we are seeking comment on all aspects of our proposal.

    1. Identifying Services that are Not New or Revised Codes

    As described in this proposed rule, the statute specifies that services described by new or revised codes are not subject to the phase-in of RVUs. We believe this exclusion recognizes the reality that there is no practical way to phase-in over 2 years changes to RVUs that occur as a result of a coding change for a particular service because there is no relevant reference code or value on which to base the transition. To determine which services are described by new or revised codes for purposes of the phase-in provision, we are proposing to apply the phase-in to all services that are described by the same, unrevised code in both the current and update year, and to exclude codes that describe different services in the current and update year. This approach would exclude services described by new codes or existing codes for which the descriptors were altered substantially for the update year to change the services that are reported using the code. We would also exclude as new and revised codes those codes that describe a different set of services in the update year when compared to the current year by virtue of changes in other, related codes, or codes that are part of a family with significant coding revisions. For example, significant coding revisions within a family of codes can change the relationships among codes to the extent that it changes the way that all services in the group are reported, even if some individual codes retain the same number or, in some cases, the same descriptor. Excluding codes from the phase-in when there are significant revisions to the code family would also help to maintain the appropriate rank order among codes in the family, avoiding years for which RVU changes for some codes in a family are in transition while others were fully implemented. This proposed application of the phase-in would also be consistent with previous RVU transitions, especially for PE RVUs, for which we only applied transition values to those codes that described the same service in both the current and the update years. We would also exclude from the phase-in as new and revised codes those codes with changes to the global period, since the code in the current year would not describe the same units of service as the code in the update year.

    2. Estimating the 20 Percent Threshold

    Because the phase-in of RVUs falls within the budget neutrality requirements specified in section 1848(c)(2)(B)(ii)(II) of the Act, we are proposing to estimate total RVUs for a service prior to the budget-

    neutrality redistributions that result from implementing phase-in values. We recognize that the result of this approach could mean that some codes may not qualify for the phase-in despite a reduction in RVUs that is ultimately slightly greater than 20 percent due to budget neutrality adjustments that are made after identifying the codes that meet the threshold in order to reflect the phase-in values for other codes. We believe the only alternative to this approach is not practicable, since it would be circular, resulting in cyclical iteration.

    3. RVUs in the First Year of the Phase-In

    Section 1848(c)(7) of the Act states that the applicable adjustments in work, PE, and MP RVUs shall be phased-in over a 2-year period when the RVU reduction for a code is estimated to be equal to or greater than 20 percent. We believe that there are two reasonable ways to determine the portion of the reduction to be phase-in for the first year. Most recent RVU transitions have distributed the values evenly across several years. For example, for a 2-year transition we would estimate the fully implemented value and set a rate

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    approximately 50 percent between the value for the current year and the value for the update year. We believe that this is the most intuitive approach to the phase-in and is likely the expectation for many stakeholders. However, we believe that the 50 percent phase-in in the first year has a significant drawback. For instance, since the statute establishes a 20 percent threshold as the trigger for phasing in the change in RVUs, under the 50 percent phase-in approach, a service that is estimated to be reduced by a total of 19 percent for an update year would be reduced by a full 19 percent in that update year, while a service that is estimated to be reduced by 20 percent in an update year would only be reduced 10 percent in that update year.

    The logical alternative approach is to consider a 19 percent reduction as the maximum 1-year reduction for any service not described by a new or revised code. This approach would be to reduce the service by the maximum allowed amount (that is, 19 percent) in the first year, and then phase in the remainder of the reduction in the second year. Under this approach, the code that is reduced by 19 percent in a year and the code that would otherwise have been reduced by 20 percent would both be reduced by 19 percent in the first year, and the latter code would see an additional 1 percent reduction in the second year of the phase-in. For most services, this would likely mean that the majority of the reduction would take place in the first year of the phase-in. However, for services with the most drastic reductions (greater than 40 percent), the majority of the reduction would take place in the second year of the phase-in.

    After considering both of these options, we are proposing to consider the 19 percent reduction as the maximum 1-year reduction and to phase-in any remaining reduction greater than 19 percent in the second year of the phase-in. We believe that this approach is more equitable for codes with significant reductions but that are less than 20 percent. We are seeking comment on this proposal.

    4. Applicable Adjustments to RVUs

    The phase-in provision instructs that the applicable adjustments in work, PE, and MP RVUs be phased-in over 2 years for any service that would otherwise be decreased by an estimated amount equal to or greater than 20 percent as compared to the total RVUs for the previous year. However, for several thousand services, we develop separate RVUs for facility and nonfacility sites of service. For nearly one thousand other services, we develop separate RVUs for the professional and technical components of the service and sum those RVUs to allow for global billing. Therefore, for individual practitioners furnishing particular services to Medicare beneficiaries, the relevant changes in RVUs for a particular code are based on the total RVUs for a code for a particular setting (facility/nonfacility) or for a particular component (professional/technical). We believe the most straightforward and fair approach to addressing both the site of service differential and the codes with professional and technical components is to consider the RVUs for the different sites of service and components independently for purposes of identifying when and how the phase-in applies. We are proposing, therefore, to estimate whether a particular code meets the 20 percent threshold for change in total RVUs by taking into account the total RVUs that apply to a particular setting or to a particular component. This would mean that if the change in total facility RVUs for a code met the threshold, then that change would be phased-in over 2 years, even if the change for the total nonfacility RVUs for the same code would not be phased-in over 2 years. Similarly, if the change in the total RVUs for the technical component of a service meets the 20 percent threshold, then that change would be phased-in over 2 years, even if the change for the professional component did not meet the threshold. (Because the global is the sum of the professional and technical components, the portion of the global attributable to the technical component would then be phased-in, while the portion attributable to the professional component would not be.)

    However, we note that we create the site of service differential exclusively by developing independent PE RVUs for each service in the nonfacility and facility settings. That is, for these codes, we use the same work RVUs and MP RVUs in both settings and vary only the PE RVUs to implement the difference in resources depending on the setting. Similarly, we use the work RVUs assigned to the professional component codes as the work RVUs for the service when billed globally. Like the codes with the site of service differential, the PE RVUs for each component are developed independently. The resulting PE RVUs are then summed for use as the PE RVUs for the code, billed globally. Since variation of PE RVUs is the only constant across all individual codes, codes with site of service differentials, and codes with professional and technical components, we are proposing to apply all adjustments for the phase-in to the PE RVUs.

    We considered alternatives to this approach. For example, for codes with a site of service differential, we considered applying a phase-in for codes in both settings (and all components) whenever the total RVUs in either setting reached the 20 percent threshold. However, there are cases where the total RVUs for a code in one setting (or one component) may reach the 20 percent reduction threshold, while the total RVUs for the other setting (or other component) are increasing. In those cases, applying phase-in values for work or MP RVUs would mean applying an additional increase in total RVUs for particular services. We also considered basing the phase-in of the RVUs for the component codes billed globally and for the codes with site of service differentials developing an overall, blended set of overall PE RVUs using a weighted average of site of service volume in the Medicare claims data. We would then compare the global or blended value in the prior year versus the global or blended value in the current year and apply the phase-in to the value for the current year before re-allocating the new value to the respective RVUs in each setting. We did not pursue this approach for several reasons. First, the resulting phase-in amounts would not relate logically to the values paid to any individual practitioner, except those who bill the PC/TC codes globally. Second, the approach would be so administratively complicated that it would likely be difficult to replicate or predict.

    Therefore, we have concluded that applying the adjustments to the PE RVUs for individual codes in order to effect the appropriate phase-

    in amount is the most straightforward and fair approach to mitigate the impact of significant reductions of total RVUs for services furnished by individual practitioners. The list of codes subject to the phase-in, and the RVUs that result from this proposed methodology, is available on the CMS Web site under downloads for the CY 2016 PFS proposed rule with comment period at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.

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  36. Changes for Computed Tomography (CT) Under the Protecting Access to Medicare Act of 2014 (PAMA) (CY 2016 only)

    1. Section 218(a) of the Protecting Access to Medicare Act of 2014 (PAMA)

    Section 218(a) of PAMA is entitled ``Quality Incentives To Promote Patient Safety and Public Health in Computed Tomography Diagnostic Imaging.'' It amends the statute by reducing payment for the technical component (TC) (and the TC of the global fee) of the PFS service and the hospital outpatient prospective payment system (OPPS) payment (5 percent in 2016 and 15 percent in 2017 and subsequent years) for computed tomography (CT) services identified by CPT codes 70450-70498, 71250-71275, 72125-72133, 72191-72194, 73200-73206, 73700-73706, 74150-

    74178, 74261-74263, and 75571-75574 furnished using equipment that does not meet each of the attributes of the National Electrical Manufacturers Association (NEMA) Standard XR-29-2013, entitled ``Standard Attributes on CT Equipment Related to Dose Optimization and Management.''

    The statutory provision requires that information be provided and attested to by a supplier and a hospital outpatient department that indicates whether an applicable CT service was furnished that was not consistent with the NEMA CT equipment standard, and that such information may be included on a claim and may be a modifier. The statutory provision also provides that such information shall be verified, as appropriate, as part of the periodic accreditation of suppliers under section 1834(e) of the Act and hospitals under section 1865(a) of the Act. Any reduced expenditures resulting from this provision are not budget neutral. To implement this provision, we will create modifier ``CT'' (Computed tomography services furnished using equipment that does not meet each of the attributes of the National Electrical Manufacturers Association (NEMA) XR-29-2013 standard). Beginning in 2016, claims for CT scans described by above-listed CPT codes (and any successor codes) that are furnished on non-NEMA Standard XR-29-2013-compliant CT scans must include modifier ``CT'' and that modifier will result in the applicable payment reduction for the service.

    I. Valuation of Specific Codes

    1. Background

    Establishing valuations for newly created and revised CPT codes is a routine part of maintaining the PFS. Since inception of the PFS, it has also been a priority to revalue services regularly to assure that the payment rates reflect the changing trends in the practice of medicine and current prices for inputs used in the PE calculations. Initially, this was accomplished primarily through the five-year review process, which resulted in revised work RVUs for CY 1997, CY 2002, CY 2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY 2011. Under the five-year review process, revisions in RVUs were proposed in a proposed rule and finalized in a final rule. In addition to the five-year reviews, in each year beginning with CY 2009, CMS and the RUC have identified a number of potentially misvalued codes using various identification screens, as discussed in section II.C. of this proposed rule. Each year, when we received RUC recommendations, our process has been to establish interim final RVUs for the potentially misvalued codes, new codes, and any other codes for which there were coding changes in the final rule with comment period for a year. Then, during the 60-day period following the publication of the final rule with comment period, we accept public comment about those valuations. For services furnished during the calendar year following the publication of interim final rates, we pay for services based upon the interim final values established in the final rule with comment period. In the final rule with comment period for the subsequent year, we consider and respond to public comments received on the interim final values, and make any appropriate adjustments to values based on those comments. We then typically finalize the values for the codes.

    2. Process for Valuing New, Revised, and Potentially Misvalued Codes

    In the CY 2015 PFS final rule with comment period, we finalized a new process for establishing values for new, revised and potentially misvalued codes. Under the new process, we include proposed values for these services in the proposed rule, rather than establishing them as interim final in the final rule with comment period. CY 2016 represents a transition year for this new process. For CY 2016, we are proposing new values in the proposed rule for the codes for which we received complete RUC recommendations by February 10, 2015. For recommendations regarding any new or revised codes received after the February 10, 2015 deadline, including updated recommendations for codes included in this proposed rule, we will establish interim final values in the final rule with comment period, consistent with previous practice. We note that we will consider all comments received in response to proposed values for codes in this rule, including alternative recommendations to those used in developing the proposed rule. In other words, if the RUC or other interested stakeholders submit public comments that include new recommendations for codes for which we propose values as part of this proposed rule, we would consider those recommendations in developing final values for the codes in the CY 2016 PFS final rule with comment.

    Beginning with valuations for CY 2017, the new process will be applicable to all codes. That is, beginning with rulemaking for CY 2017, we will propose values for the vast majority of new, revised, and potentially misvalued codes and consider public comments before establishing final values for the codes; use G-codes as necessary to facilitate continued payment for certain services for which we do not receive recommendations in time to propose values; and adopt interim final values in the case of wholly new services for which there are no predecessor codes or values and for which we do not receive recommendations in time to propose values.

    For CY 2016, we received RUC recommendations prior to February 10, 2015 for many new, revised and potentially misvalued codes and have included proposed values for these codes in this proposed rule. However, the RUC recommendations included CPT tracking codes instead of the actual 2016 CPT codes that will first be made available to the public subsequent to the publication of this proposed rule. Because CPT procedure codes are 5 alpha-numeric characters but CPT tracking codes typically have 6 or 7 alpha-numeric characters and CMS systems only utilize 5-character HCPCS codes, we have developed and used alternative 5-character placeholder codes for this proposed rule. For the convenience of stakeholders and commenters with access to the CPT tracking codes, we have displayed a crosswalk from the 5-character placeholder codes to the CPT tracking codes on our Web site under downloads for the CY 2016 PFS proposed rule at http://www.cms.gov/PhysicianFeeSched/downloads/. The final CPT codes will be included in the CY 2016 final rule with comment period.

    3. Methodology for Establishing Work RVUs

    We conducted a review of each code identified in this section and reviewed the current work RVU (if any), RUC-

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    recommended work RVUs, intensity, time to furnish the preservice, intraservice, and postservice activities, as well as other components of the service that contribute to the value. Our review of recommended work RVUs and time generally includes, but is not limited to, a review of information provided by the RUC, HCPAC, and other public commenters, medical literature, and comparative databases, as well as a comparison with other codes within the Medicare PFS, consultation with other physicians and health care professionals within CMS and the federal government, as well as Medicare claims data. We also assessed the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters and the rationale for the recommendations. In the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329), we discussed a variety of methodologies and approaches used to develop work RVUs, including survey data, building blocks, crosswalk to key reference or similar codes, and magnitude estimation. More information on these issues is available in that rule. When referring to a survey, unless otherwise noted, we mean the surveys conducted by specialty societies as part of the formal RUC process. The building block methodology is used to construct, or deconstruct, the work RVU for a CPT code based on component pieces of the code. Components used in the building block approach may include preservice, intraservice, or postservice time and post-procedure visits. When referring to a bundled CPT code, the building block components could be the CPT codes that make up the bundled code and the inputs associated with those codes. Magnitude estimation refers to a methodology for valuing physician work that determines the appropriate work RVU for a service by gauging the total amount of physician work for that service relative to the physician work for similar service across the PFS without explicitly valuing the components of that work.

    The PFS incorporates cross-specialty and cross-organ system relativity. Valuing services requires an assessment of relative value and takes into account the clinical intensity and time required to furnish a service. In selecting which methodological approach will best determine the appropriate value for a service, we consider the current and recommended work and time values, as well as the intensity of the service, all relative to other services.

    Several years ago, to aid in the development of preservice time recommendations for new and revised CPT codes, the RUC created standardized preservice time packages. The packages include preservice evaluation time, preservice positioning time, and preservice scrub, dress and wait time. Currently there are six preservice time packages for services typically furnished in the facility setting, reflecting the different combinations of straightforward or difficult procedure, straightforward or difficult patient, and without or with sedation/

    anesthesia. Currently, there are three preservice time packages for services typically furnished in the nonfacility setting, reflecting procedures without and with sedation/anesthesia care.

    We have developed several standard building block methodologies to value services appropriately when they have common billing patterns. In cases where a service is typically furnished to a beneficiary on the same day as an evaluation and management (E/M) service, we believe that there is overlap between the two services in some of the activities furnished during the preservice evaluation and postservice time. We believe that at least one-third of the work time in both the preservice evaluation and postservice period is duplicative of work furnished during the E/M visit. Accordingly, in cases where we believe that the RUC has not adequately accounted for the overlapping activities in the recommended work RVU and/or times, we adjust the work RVU and/or times to account for the overlap. The work RVU for a service is the product of the time involved in furnishing the service times the intensity of the work. Preservice evaluation time and postservice time both have a long-established intensity of work per unit of time (IWPUT) of 0.0224, which means that 1 minute of preservice evaluation or postservice time equates to 0.0224 of a work RVU. Therefore, in many cases when we remove 2 minutes of preservice time and 2 minutes of postservice time from a procedure to account for the overlap with the same day E/M service, we also remove a work RVU of 0.09 (4 minutes x 0.0224 IWPUT) if we do not believe the overlap in time has already been accounted for in the work RVU. The RUC has recognized this valuation policy and, in many cases, addresses the overlap in time and work when a service is typically provided on the same day as an E/M service.

    Table 11 contains a list of proposed work RVUs for all codes with RUC recommendations received by February 10, 2015. Proposed work RVUs that vary from those recommended by the RUC or for which we do not have RUC recommendations are addressed in the portions of this section that are dedicated to particular codes.

    The work RVUs and other payment information for all CY 2016 payable codes are available in Addendum B, including codes for which we have proposed changes in this proposed rule subject to public comment. Addendum B is available on the CMS Web site under downloads for the CY 2016 PFS proposed rule at http://www.cms.gov/PhysicianFeeSched/downloads/. The proposed time values for all CY 2016 codes are listed in a file called ``CY 2016 PFS Work Time,'' available on the CMS Web site under downloads for the CY 2016 PFS proposed rule at http://www.cms.gov/PhysicianFeeSched/downloads/.

    4. Methodology for Establishing the Direct PE Inputs Used to Develop PE RVUs

    a. Background

    On an annual basis, the RUC provides CMS with recommendations regarding PE inputs for new, revised, and potentially misvalued codes. We review the RUC-recommended direct PE inputs on a code-by-code basis. Like our review of recommended work RVUs, our review of recommended direct PE inputs generally includes, but is not limited to, a review of information provided by the RUC, HCPAC, and other public commenters, medical literature, and comparative databases, as well as a comparison with other codes within the Medicare PFS, consultation with other physicians and health care professionals within CMS and the federal government, as well as Medicare claims data. We also assess the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters and the rationale for the recommendations. When we determine that the RUC recommendations appropriately estimate the direct PE inputs (clinical labor, disposable supplies, and medical equipment) required for the typical service, consistent with the principles of relativity, and reflect our payment policies, we use those direct PE inputs to value a service. If not, we refine the recommended PE inputs to better reflect our estimate of the PE resources required for the service. We also confirm whether CPT codes should have facility and/or nonfacility direct PE inputs and refine the inputs accordingly.

    Our review and refinement of RUC-recommended direct PE input includes many refinements that are common

    Page 41718

    across codes as well as refinements that are specific to particular services. Table 13 details our refinements of the RUC's direct PE recommendations at the code-specific level. In this proposed rule, we address several refinements that are common across codes, and refinements to particular codes are addressed in the portions of this section that are dedicated to particular codes. We note that for each refinement, we indicate the impact on direct costs for that service. We point out that, on average, in any case where the impact on the direct cost for a particular refinement is $0.32 or less, the refinement has no impact on the final PE RVUs. This calculation considers both the impact on the direct portion of the PE RVU as well as the impact on the indirect allocator for the average service. We also note that nearly half of the refinements listed in Table 13 result in changes under the $0.32 threshold and are unlikely to result in a change to the final RVUs.

    We also note that the proposed direct PE inputs for CY 2016 are displayed in the proposed CY 2016 direct PE input database, available on the CMS Web site under the downloads for the CY 2016 proposed rule at www.cms.gov/PhysicianFeeSched/. The inputs displayed there have also been used in developing the CY 2016 PE RVUs as displayed in Addendum B of this proposed rule.

    b. Common Refinements

    (1) Changes in Work Time

    Some direct PE inputs are directly affected by revisions in work time. Specifically, changes in the intraservice portions of the work time and changes in the number or level of postoperative visits associated with the global periods result in corresponding changes to direct PE inputs. Although the direct PE input recommendations generally correspond to the work time values associated with services, we believe that in some cases inadvertent discrepancies between work time values and direct PE inputs should be refined in the establishment of proposed direct PE inputs. In other cases, CMS refinement of recommended proposed work times prompts necessary adjustments in the direct PE inputs.

    (2) Equipment Time

    Prior to CY 2010, the RUC did not generally provide CMS with recommendations regarding equipment time inputs. In CY 2010, in the interest of ensuring the greatest possible degree of accuracy in allocating equipment minutes, we requested that the RUC provide equipment times along with the other direct PE recommendations, and we provided the RUC with general guidelines regarding appropriate equipment time inputs. We continue to appreciate the RUC's willingness to provide us with these additional inputs as part of its PE recommendations.

    In general, the equipment time inputs correspond to the service period portion of the clinical labor times. We have clarified this principle, indicating that we consider equipment time as the time within the intraservice period when a clinician is using the piece of equipment plus any additional time that the piece of equipment is not available for use for another patient due to its use during the designated procedure. For those services for which we allocate cleaning time to portable equipment items, because the portable equipment does not need to be cleaned in the room where the service is furnished, we do not include that cleaning time for the remaining equipment items as those items and the room are both available for use for other patients during that time. In addition, when a piece of equipment is typically used during follow-up post-operative visits included in the global period for a service, the equipment time would also reflect that use.

    We believe that certain highly technical pieces of equipment and equipment rooms are less likely to be used during all of the pre-

    service or post-service tasks performed by clinical labor staff on the day of the procedure (the clinical labor service period) and are typically available for other patients even when one member of clinical staff may be occupied with a pre-service or post-service task related to the procedure. We also note that we believe these same assumptions would apply to inexpensive equipment items that are used in conjunction with and located in a room with non-portable highly technical equipment items. Some stakeholders have objected to this rationale for our refinement of equipment minutes on this basis. We refer readers to our extensive discussion in response to those objections in the CY 2012 PFS final rule with comment period (76 FR 73182) and the CY 2015 PFS final rule with comment period (79 FR 67639).

    (3) Standard Tasks and Minutes for Clinical Labor Tasks

    In general, the preservice, intraservice period, and postservice clinical labor minutes associated with clinical labor inputs in the direct PE input database reflect the sum of particular tasks described in the information that accompanies the RUC-recommended direct PE inputs, commonly called the ``PE worksheets.'' For most of these described tasks, there are a standardized number of minutes, depending on the type of procedure, its typical setting, its global period, and the other procedures with which it is typically reported. The RUC sometimes recommends a number of minutes either greater than or less than the time typically allotted for certain tasks. In those cases, CMS staff reviews the deviations from the standards and any rationale provided for the deviations. When we do not accept the RUC-recommended exceptions, we refine the proposed direct PE inputs to match the standard times for those tasks. In addition, in cases when a service is typically billed with an E/M service, we remove the pre-service clinical labor tasks to avoid duplicative inputs and to reflect the resource costs of furnishing the typical service.

    In general, clinical labor tasks fall into one of the categories on the PE worksheets. In cases where tasks cannot be attributed to an existing category, the tasks are labeled ``other clinical activity.'' We believe that continual addition of new and distinct clinical labor tasks each time a code is reviewed under the misvalued code initiative is likely to degrade relativity between newly reviewed services and those with already existing inputs. To mitigate the potential negative impact of these additions, our staff reviews these tasks to determine whether they are fully distinct from existing clinical labor tasks, typically included for other clinically similar services under the PFS, and thoroughly explained in the recommendation. For those tasks that do not meet these criteria, we do not accept these newly recommended clinical labor tasks; two examples of such tasks encountered during our review of the recommendations include ``Enter data into laboratory information system, multiparameter analyses and field data entry, complete quality assurance documentation'' and ``Consult with pathologist regarding representation needed, block selection and appropriate technique.''

    In conducting our review of the RUC recommendations for CY 2016, we noted that several of the recommended times for clinical labor tasks associated with pathology services differed across codes, both within the CY 2016 recommendations and in comparison to codes currently in the direct PE database. We refer readers to Table 6 in section II.A.3. of this proposed rule where we outline our proposed standard times for clinical labor tasks associated with pathology services.

    Page 41719

    (4) Recommended Items That Are Not Direct PE Inputs

    In some cases, the PE worksheets included with the RUC recommendations include items that are not clinical labor, disposable supplies, or medical equipment that cannot be allocated to individual services or patients. Two examples of such items are ``emergency service container/safety kit'' and ``service contract.'' We have addressed these kinds of recommendations in previous rulemaking (78 FR 74242), and we do not use these recommended items as direct PE inputs in the calculation of PE RVUs.

    (5) Moderate Sedation Inputs

    In the CY 2012 PFS final rule (76 FR 73043 through 73049), we finalized a standard package of direct PE inputs for services where moderate sedation is considered inherent in the procedure. In the CY 2015 final rule with comment period, we finalized a refinement to the standard package to include a stretcher for the same length of time as the other equipment items in the standard package. We are proposing to refine the RUC's direct PE recommendations to conform to these policies. This includes the removal of a power table where it was included during the intraservice period, as the stretcher takes the place of the table. These refinements are reflected in the final CY 2016 PFS direct PE input database and detailed in Table 13.

    (6) New Supply and Equipment Items

    The RUC generally recommends the use of supply and equipment items that already exist in the direct PE input database for new, revised, and potentially misvalued codes. Some recommendations include supply or equipment items that are not currently in the direct PE input database. In these cases, the RUC has historically recommended a new item be created and has facilitated our pricing of that item by working with the specialty societies to provide copies of sales invoices to us. We received invoices for several new supply and equipment items for CY 2016. We have accepted the majority of these items and added them to the direct PE input database. Tables 9 and 10 detail the invoices received for new and existing items in the direct PE database. As discussed in section II.A. of this proposed rule, we encourage stakeholders to review the prices associated with these new and existing items to determine whether these prices appear to be accurate. Where prices appear inaccurate, we encourage stakeholders to provide invoices or other information to improve the accuracy of pricing for these items in the direct PE database. We remind stakeholders that due to the relativity inherent in the development of RVUs, reductions in existing prices for any items in the direct PE database increase the pool of direct PE RVUs available to all other PFS services. Tables 9 and 10 also include the number of invoices received as well as the number of nonfacility allowed services for procedures that use these equipment items. We provide the nonfacility allowed services so that stakeholders will note the impact the particular price might have on PE relativity, as well as to identify items that are used frequently, since we believe that stakeholders are more likely to have better pricing information for items used more frequently. We are concerned that a single invoice may not be reflective of typical costs and encourage stakeholders to provide additional invoices so that we might identify and use accurate prices in the development of PE RVUs.

    In some cases, we do not accept the price listed on the invoice that accompanies the recommendation because we identify publicly available alternative prices or information that suggests a different price is more accurate. In these cases, we include this in the discussion of these codes. In other cases, we cannot adequately price a newly recommended item due to inadequate information. Sometimes, no supporting information regarding the price of the item has been included in the recommendation. In other cases, the supporting information does not demonstrate that the item has been purchased at the listed price (for example, vendor price quotes instead of paid invoices). In cases where the information provided on the item allows us to identify clinically appropriate proxy items, we might use existing items as proxies for the newly recommended items. In other cases, we have included the item in the direct PE input database without any associated price. Although including the item without an associated price means that the item does not contribute to the calculation of the proposed PE RVU for particular services, it facilitates our ability to incorporate a price once we obtain information and are able to do so.

    (7) Service Period Clinical Labor Time in the Facility Setting

    Several of the PE worksheets included in the RUC recommendations contained clinical labor minutes assigned to the service period in the facility setting. Our proposed inputs do not include these minutes because the cost of clinical labor during the service period for a procedure in the facility setting is not considered a resource cost to the practitioner since Medicare makes separate payment to the facility for these costs.

    (8) Duplicative Inputs

    Several of the PE worksheets included in the RUC recommendations contained time for the equipment item ``xenon light source'' (EQ167). Because there appear to be two special light sources already present (the fiberoptic headlight and the endoscope itself) in the services for which this equipment item was recommended, we are not proposing to include the time for this equipment item from these services, and are seeking comment on whether there is a rationale for including this additional light source as a direct PE input for these procedures.

    5. Methodology for Establishing Malpractice RVUs

    As discussed in section II.B. of this proposed rule, our malpractice methodology uses a crosswalk to establish risk factors for new services until utilization data becomes available. Table 15 lists the CY 2016 HCPCS codes and their respective source codes used to set the proposed CY 2016 MP RVUs. The MP RVUs for these services are reflected in Addendum B on the CMS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.

    Table 9--Invoices Received for New Direct PE Inputs

    --------------------------------------------------------------------------------------------------------------------------------------------------------

    Estimated non-facility

    Number of allowed services for

    CPT/HCPCS Codes Item name CMS Code Average price invoices HCPCS codes using this

    item

    --------------------------------------------------------------------------------------------------------------------------------------------------------

    31626................................... Gold Fiducial Marker....... SB053 135............................ 1 6

    Page 41720

    3160A, 3160B, 3160C..................... endoscope, ultrasound ES045 0.............................. 0 212

    radial probe.

    3725A................................... IVUS catheter.............. SD304 1025........................... 3 795

    3725A................................... IVUS Catheter Sterile Cover SD305 120............................ 3 795

    3725A, 3725B............................ IVUS system................ ES047 134,025........................ 3 2,948

    44385, 44386, 45330, 45331, 45332, Video Sigmoidoscope........ ES043 215,00......................... 1 18,058

    45333, 45334, 45335, 45338, 45340,

    45346.

    44401, 45346, 45388..................... catheter, RF ablation, SC103 1,780.......................... 1 3,543

    endoscopic.

    44401, 45346............................ radiofrequency generator, EQ369 108,291.67..................... 1 174

    endoscopy.

    45350, 45398............................ hemorrhoidal banding system SA115 223.50......................... 4 3

    5039D, 5039M............................ Nephroureteral Catheter.... SD306 117.90......................... 1 70

    657XG................................... suture, nylon, 10-0........ SC104 12.17.......................... 2

    657XG................................... intrastromal corneal ring.. SA120 1,145.......................... 7

    657XG................................... patient/laser interface SD307 172.50......................... 1

    (single--use, disposable).

    657XG................................... femtosecond laser.......... ES048 293,000........................ 2

    657XG................................... incision programming ES049 10,012.50...................... 1

    software.

    692XX................................... earwash bottle disposable SD308 1.72........................... 1

    tips.

    77385, 77386, 77402, 77407, 77412....... Power Conditioner.......... ER102 26,400......................... 2 2,198,441

    7778A, 7778B, 7778C, 7778D, 7778E....... brachytherapy treatment ES052 175,000........................ 1 24,936

    vault.

    88104, 88106, 88108..................... fixative spray for cytospin SL503 1.53........................... 1 62,552

    88108................................... Shannon cyto funnel, SD298 2.27........................... 1 48,740

    cytospin.

    88108................................... slide, microscope coated SL504 0.39........................... 1 48,740

    cytospin (single circle).

    88182................................... Protease................... SL506 0.43........................... 1 568

    88346, 8835X............................ Immunofluorescent mounting SD309 3.50........................... 1 114,211

    media.

    88346, 8835X............................ Zeus medium................ SL518 0.85........................... 2 114,211

    88346, 8835X............................ Hydrophobic PAP Pen........ SK120 1.76........................... 1 114,211

    (100 uses).....................

    88360, 88361............................ Antibody Estrogen Receptor SL493 13.89.......................... 3 116,718

    monoclonal.

    --------------------------------------------------------------------------------------------------------------------------------------------------------

    Table 10--Invoices Received for Existing Direct PE Inputs

    --------------------------------------------------------------------------------------------------------------------------------------------------------

    Estimated non-facility

    Current Updated Percent Number of allowed services for

    CPT/HCPCS Codes Item name CMS Code price price change invoices HCPCS codes using this

    item

    --------------------------------------------------------------------------------------------------------------------------------------------------------

    31300, 31320, 31360, 31365, 31367, 31368, endosheath.................. SD070 9.50 17.25 82 1 65,318

    31370, 31375, 31380, 31382, 31390,

    31395, 31628, 31632, 31750, 31755,

    31800, 41120, 41130, 41135, 41140,

    41145, 41150, 41153, 41155, 41500,

    41510, 41512, 41530, 42120, 42842,

    42844, 42845, 42870, 42890, 42892,

    42894, 42950, 42953, 42955, 43215,

    43247, 58555, 58558, 58562, 58563,

    60605, 92511, 92612.

    41530, 43228, 43229, 43270, 64633, 64634, radiofrequency generator EQ214 32,900 10,000 -70 1 265,270

    64635, 64636. (NEURO).

    88341, 88342, 88343, 88344, 88360, 88361. Benchmark ULTRA automated EP112 134,000 150,000 12 1 3,279,993

    slide preparation system.

    8835X.................................... antibody IgA FITC........... SL012 71.40 41.18 -42 1 93,520

    95018.................................... benzylpenicilloyl polylysine SH103 72.45 83.00 15 1 60,683

    (eg, PrePen) 0.25ml uou.

    Page 41721

    95923.................................... kit, electrode, SA014 11.99 4.01 -67 3 96,189

    iontophoresis.

    --------------------------------------------------------------------------------------------------------------------------------------------------------

    6. CY 2016 Valuation of Specific Codes

    Table 11--CY 2016 Proposed Work RVUs for New, Revised and Potentially Misvalued Codes

    ----------------------------------------------------------------------------------------------------------------

    CMS time

    HCPCS Descriptor Current work RVU RUC work RVU CMS work RVU refinement

    ----------------------------------------------------------------------------------------------------------------

    11750......... Removal of nail......... 2.5................. 1.99 1.58 No.

    20240......... Biopsy of bone, open 3.28................ 3.73 2.61 No.

    procedure.

    27280......... Arthrodesis, open, 14.64............... 20 20 No.

    sacroiliac joint

    including obtaining

    bone graft.

    3160A......... Bronchoscopy, rigid or NEW................. 5 4.71 No.

    flexible, including

    fluoroscopic guidance,

    when performed; with

    endobronchial

    ultrasound (EBUS)

    guided transtracheal

    and/or transbronchial

    sampling (eg,

    aspirations/

    biopsyies), one or

    two mediastinal and/or

    hilar lymph node stat.

    3160B......... Bronchoscopy, rigid or NEW................. 5.5 5.21 No.

    flexible, including

    fluoroscopic guidance,

    when performed; with

    endobronchial

    ultrasound (EBUS)

    guided transtracheal

    and/or transbronchial

    sampling (eg,

    aspirations/

    biopsyies), 3 or more

    mediastinal and/or

    hilar lymph node stati.

    3160C......... Bronchoscopy, rigid or NEW................. 1.7 1.4 No.

    flexible, including

    fluoroscopic guidance,

    when performed; with

    transendoscopic

    endobronchial

    ultrasound (EBUS)

    during bronchoscopic

    diagnostic or

    therapeutic

    intervention(s) for

    peripheral lesion(s)

    (List separately in

    addition to.

    31622......... Diagnostic examination 2.78................ 2.78 2.78 No.

    of lung airways using

    an endoscope.

    31625......... Biopsy of lung airways 3.36................ 3.36 3.36 No.

    using an endoscope.

    31626......... Insertion of radiation 4.16................ 4.16 4.16 No.

    therapy markers into

    lung airways using an

    endoscope.

    31628......... Biopsy of one lobe of 3.8................. 3.8 3.8 No.

    lung using an endoscope.

    31629......... Needle biopsy of 4.09................ 4 4 No.

    windpipe cartilage,

    airway, and/or lung

    using an endoscope.

    31632......... Biopsy of lung using an 1.03................ 1.03 1.03 No.

    endoscope.

    31633......... Needle biopsy of lung 1.32................ 1.32 1.32 No.

    using an endoscope.

    3347A......... Transcatheter pulmonary NEW................. 25 25 No.

    valve implantation,

    percutaneous approach,

    including pre-stenting

    of the valve delivery

    site, when performed.

    37215......... Transcatheter placement 19.68............... 18 18 No.

    of intravascular

    stent(s), cervical

    carotid artery,

    percutaneous; with

    distal embolic

    protection.

    3725A......... Intravascular ultrasound NEW................. 1.8 1.8 No.

    (noncoronary vessel)

    during diagnostic

    evaluation and/or

    therapeutic

    intervention, including

    radiological

    supervision and

    interpretation; initial

    non-coronary vessel

    (List separately in

    addition to code for

    primary procedure).

    3725B......... Intravascular ultrasound NEW................. 1.44 1.44 No.

    (noncoronary vessel)

    during diagnostic

    evaluation and/or

    therapeutic

    intervention, including

    radiological

    supervision and

    interpretation; each

    additional noncoronary

    vessel (List separately

    in addition to code for

    primary procedure.

    38570......... Removal of abdominal 9.34................ 9.34 8.49 No.

    cavity lymph nodes

    using an endoscope.

    38571......... Removal of total lymph 14.76............... 12 12 No.

    nodes of both sides of

    pelvis using an

    endoscope.

    38572......... Removal of total lymph 16.94............... 15.6 15.6 No.

    nodes of both sides of

    pelvis and abdominal

    lymph node biopsy using

    an endoscope.

    3940A......... Mediastinoscopy; NEW................. 5.44 5.44 No.

    includes biopsy(ies) of

    mediastinal mass (eg,

    lymphoma), when

    performed.

    3940B......... Mediastinoscopy; with NEW................. 7.5 7.25 No.

    lymph node biopsy(ies)

    (eg, lung cancer

    staging).

    43775......... Stomach reduction C................... 21.4 20.38 No.

    procedure with partial

    removal of stomach

    using an endoscope.

    44380......... Ileoscopy, through 1.05................ 0.97 0.9 No.

    stoma; diagnostic,

    including collection of

    specimen(s) by brushing

    or washing, when

    performed.

    44381......... Ileoscopy, through N/A................. 1.48 1.48 Yes

    stoma; with

    transendoscopic balloon

    dilation.

    44382......... Ileoscopy, through 1.27................ 1.27 1.2 No.

    stoma; with biopsy,

    single or multiple.

    44384......... Ileoscopy, through N/A................. 3.11 2.88 No.

    stoma; with placement

    of endoscopic stent

    (includes pre- and post-

    dilation and guide wire

    passage, when

    performed).

    Page 41722

    44385......... Endoscopic evaluation of 1.82................ 1.3 1.23 No.

    small intestinal pouch

    (eg, Kock pouch, ileal

    reservoir S or J);

    diagnostic, including

    collection of

    specimen(s) by brushing

    or washing, when

    performed.

    44386......... Endoscopic evaluation of 2.12................ 1.6 1.53 No.

    small intestinal pouch

    (eg, Kock pouch, ileal

    reservoir S or J);

    with biopsy, single or

    multiple.

    44388......... Colonoscopy through 2.82................ 2.82 2.75 No.

    stoma; diagnostic,

    including collection of

    specimen(s) by brushing

    or washing, when

    performed (separate

    procedure).

    44389......... Colonoscopy through 3.13................ 3.12 3.05 No.

    stoma; with biopsy,

    single or multiple.

    44390......... Colonoscopy through 3.82................ 3.82 3.77 No.

    stoma; with removal of

    foreign body.

    44391......... Colonoscopy through 4.31................ 4.22 4.22 No.

    stoma; with control of

    bleeding, any method.

    44392......... Colonoscopy through 3.81................ 3.63 3.63 No.

    stoma; with removal of

    tumor(s), polyp(s), or

    other lesion(s) by hot

    biopsy forceps or

    bipolar cautery.

    44394......... Colonoscopy through 4.42................ 4.13 4.13 No.

    stoma; with removal of

    tumor(s), polyp(s), or

    other lesion(s) by

    snare technique.

    44401......... Colonoscopy through N/A................. 4.44 4.44 No.

    stoma; with ablation of

    tumor(s), polyp(s), or

    other lesion (includes

    pre-and post-dilation

    and guide wire passage,

    when performed).

    44402......... Colonoscopy through N/A................. 4.96 4.73 No.

    stoma; with endoscopic

    stent placement

    (including pre- and

    post-dilation and

    guidewire passage, when

    performed).

    44403......... Colonoscopy through N/A................. 5.81 5.53 No.

    stoma; with endoscopic

    mucosal resection.

    44404......... Colonoscopy through N/A................. 3.13 3.05 No.

    stoma; with directed

    submucosal

    injection(s), any

    substance.

    44405......... Colonoscopy through N/A................. 3.33 3.33 No.

    stoma; with

    transendoscopic balloon

    dilation.

    44406......... Colonoscopy through N/A................. 4.41 4.13 No.

    stoma; with endoscopic

    ultrasound examination,

    limited to the sigmoid,

    descending, transverse,

    or ascending colon and

    cecum and adjacent

    structures.

    44407......... Colonoscopy through N/A................. 5.06 5.06 No.

    stoma; with

    transendoscopic

    ultrasound guided

    intramural or

    transmural fine needle

    aspiration/biopsy(s),

    includes endoscopic

    ultrasound examination

    limited to the sigmoid,

    descending, transverse,

    or ascending colon and

    cecum and adjace.

    44408......... Colonoscopy through N/A................. 4.24 4.24 No.

    stoma; with

    decompression (for

    pathologic distention)

    (eg, volvulus,

    megacolon), including

    placement of

    decompression tube,

    when performed.

    45330......... Sigmoidoscopy, flexible; 0.96................ 0.84 0.77 No.

    diagnostic, including

    collection of

    specimen(s) by brushing

    or washing when

    performed.

    45331......... Sigmoidoscopy, flexible; 1.15................ 1.14 1.07 No.

    with biopsy, single or

    multiple.

    45332......... Sigmoidoscopy, flexible; 1.79................ 1.85 1.79 No.

    with removal of foreign

    body.

    45333......... Sigmoidoscopy, flexible; 1.79................ 1.65 1.65 No.

    with removal of

    tumor(s), polyp(s), or

    other lesion(s) by hot

    biopsy forceps.

    45334......... Sigmoidoscopy, flexible; 2.73................ 2.1 2.1 No.

    with control of

    bleeding, any method.

    45335......... Sigmoidoscopy, flexible; 1.46................ 1.15 1.07 No.

    with directed

    submucosal

    injection(s), any

    substance.

    45337......... Sigmoidoscopy, flexible; 2.36................ 2.2 2.2 No.

    with decompression (for

    pathologic distention)

    (eg, volvulus,

    megacolon), including

    placement of

    decompression tube,

    when performed.

    45338......... Sigmoidoscopy, flexible; 2.34................ 2.15 2.15 No.

    with removal of

    tumor(s), polyp(s), or

    other lesion(s) by

    snare technique.

    45340......... Sigmoidoscopy, flexible; 1.89................ 1.35 1.35 No.

    with transendoscopic

    balloon dilation.

    45341......... Sigmoidoscopy, flexible; 2.6................. 2.43 2.15 No.

    with endoscopic

    ultrasound examination.

    45342......... Sigmoidoscopy, flexible; 4.05................ 3.08 3.08 No.

    with transendoscopic

    ultrasound guided

    intramural or

    transmural fine needle

    aspiration/biopsy(s).

    45346......... Sigmoidoscopy, flexible; N/A................. 2.97 2.84 No.

    with ablation of

    tumor(s), polyp(s), or

    other lesion(s)

    (includes pre- and post-

    dilation and guide wire

    passage, when

    performed).

    45347......... Sigmoidoscopy, flexible; N/A................. 2.98 2.75 No.

    with placement of

    endoscopic stent

    (includes pre- and post-

    dilation and guide wire

    passage, when

    performed).

    45349......... Sigmoidoscopy, flexible; N/A................. 3.83 3.55 No.

    with endoscopic mucosal

    resection.

    45350......... Sigmoidoscopy, N/A................. 1.78 1.78 No.

    flexible;with banding

    (eg, hemorrhoids).

    45378......... Colonoscopy, flexible; 3.69................ 3.36 3.29 No.

    diagnostic, including

    collection of

    specimen(s) by brushing

    or washing, when

    performed, (separate

    procedure).

    45379......... Colonoscopy, flexible; 4.68................ 4.37 4.31 No.

    with removal of foreign

    body.

    45380......... Colonoscopy, flexible, 4.43................ 3.66 3.59 No.

    proximal to splenic

    flexure; with biopsy,

    single or multiple.

    45381......... Colonoscopy, flexible; 4.19................ 3.67 3.59 No.

    with directed

    submucosal

    injection(s), any

    substance.

    45382......... Colonoscopy, flexible; 5.68................ 4.76 4.76 No.

    with control of

    bleeding, any method.

    Page 41723

    45384......... Colonoscopy, flexible; 4.69................ 4.17 4.17 No.

    with removal of

    tumor(s), polyp(s), or

    other lesion(s) by hot

    biopsy forceps or

    bipolar cautery.

    45385......... Colonoscopy, flexible; 5.3................. 4.67 4.67 No.

    with removal of

    tumor(s), polyp(s), or

    other lesion(s) by

    snare technique.

    45386......... Colonoscopy, flexible; 4.57................ 3.87 3.87 No.

    with transendoscopic

    balloon dilation.

    45388......... Colonoscopy, flexible; N/A................. 4.98 4.98 No.

    with ablation of

    tumor(s), polyp(s), or

    other lesion(s)

    (includes pre- and post-

    dilation and guide wire

    passage, when

    performed).

    45389......... Colonoscopy, flexible; N/A................. 5.5 5.27 No.

    with endoscopic stent

    placement (includes pre-

    and post-dilation and

    guide wire passage,

    when performed).

    45390......... Colonoscopy, flexible; N/A................. 6.35 6.07 No.

    with endoscopic mucosal

    resection.

    45391......... Colonoscopy, flexible; 5.09................ 4.95 4.67 No.

    with endoscopic

    ultrasound examination

    limited to the rectum,

    sigmoid, descending,

    transverse, or

    ascending colon and

    cecum, and adjacent

    structures.

    45392......... Colonoscopy, flexible; 6.54................ 5.6 5.6 No.

    with transendoscopic

    ultrasound guided

    intramural or

    transmural fine needle

    aspiration/biopsy(s),

    includes endoscopic

    ultrasound examination

    limited to the rectum,

    sigmoid, descending,

    transverse, or

    ascending colon and

    cecum, and a.

    45393......... Colonoscopy, flexible; N/A................. 4.78 4.78 No.

    with decompression (for

    pathologic distention)

    (eg, volvulus,

    megacolon), including

    placement of

    decompression tube,

    when performed.

    45398......... Colonoscopy, flexible; N/A................. 4.3 4.3 No.

    with banding, (eg,

    hemorrhoids).

    46500......... Injection of hemorrhoids 1.69................ 1.69 1.42 No.

    46601......... Anoscopy; diagnostic, N/A................. 1.6 1.6 No.

    with high-resolution

    magnification.

    46607......... Anoscopy; with high- N/A................. 2.2 2.2 No.

    resolution

    magnification (hra),

    with biopsy, single or

    multiple.

    47135......... Transplantation of donor 83.64............... 91.78 90 No.

    liver to anatomic

    position.

    50390......... Aspiration and/or 1.96................ 1.96 1.96 No.

    injection kidney cyst,

    accessed through the

    skin.

    5039A......... Injection procedure for NEW................. 3.15 3.15 No.

    antegrade nephrostogram

    and/or ureterogram,

    complete diagnostic

    procedure including

    imaging guidance (eg,

    ultrasound and

    fluoroscopy) and all

    associated radiological

    supervision and

    interpretation; new

    access.

    5039B......... Injection procedure for NEW................. 1.42 1.1 No.

    antegrade nephrostogram

    and/or ureterogram,

    complete diagnostic

    procedure including

    imaging guidance (eg,

    ultrasound and

    fluoroscopy) and all

    associated radiological

    supervision and

    interpretation;

    existing access.

    5039C......... Placement of nephrostomy NEW................. 4.7 4.25 No.

    catheter, percutaneous,

    including diagnostic

    nephrostogram and/or

    ureterogram when

    performed, imaging

    guidance (eg,

    ultrasound and/or

    fluoroscopy) and all

    associated radiological

    supervision and

    interpretation.

    5039D......... Placement of NEW................. 5.75 5.3 No.

    nephroureteral

    catheter, percutaneous,

    including diagnostic

    nephrostogram and/or

    ureterogram when

    performed, imaging

    guidance (eg,

    ultrasound and/or

    fluoroscopy) and all

    associated radiological

    supervision and

    interpretation, new

    access.

    5039E......... Exchange nephrostomy NEW................. 2 1.82 No.

    catheter, percutaneous,

    including diagnostic

    nephrostogram and/or

    ureterogram when

    performed, imaging

    guidance (eg,

    ultrasound and/or

    fluoroscopy) and all

    associated radiological

    supervision and

    interpretation.

    5039M......... Convert nephrostomy NEW................. 4.2 4 No.

    catheter to

    nephroureteral

    catheter, percutaneous,

    including diagnostic

    nephrostogram and/or

    ureterogram when

    performed, imaging

    guidance (eg,

    ultrasound and/or

    fluoroscopy) and all

    associated radiological

    supervision and

    interpretation.

    5069G......... Placement of ureteral NEW................. 4.6 4.21 No.

    stent, percutaneous,

    including diagnostic

    nephrostogram and/or

    ureterogram when

    performed, imaging

    guidance (eg,

    ultrasound and/or

    fluoroscopy) and all

    associated radiological

    supervision and

    interpretation; pre-

    existing nephrostomy.

    5069H......... Placement of ureteral NEW................. 6 5.5 No.

    stent, percutaneous,

    including diagnostic

    nephrostogram and/or

    ureterogram when

    performed, imaging

    guidance (eg,

    ultrasound and/or

    fluoroscopy) and all

    associated radiological

    supervision and

    interpretation; new

    access, without

    separate.

    5069I......... Placement of ureteral NEW................. 7.55 7.05 No.

    stent, percutaneous,

    including diagnostic

    nephrostogram and/or

    ureterogram when

    performed, imaging

    guidance (eg,

    ultrasound and/or

    fluoroscopy) and all

    associated radiological

    supervision and

    interpretation; new

    access, with separate.

    5443A......... Repair of traumatic NEW................. 11.5 11.5 No.

    corporeal tear(s).

    5443B......... Replantation, penis, NEW................. 24.5 22.1 No.

    complete amputation

    including urethral

    repair.

    Page 41724

    63045......... Laminectomy, facetectomy 17.95............... 17.95 17.95 No.

    and foraminotomy;

    cervical.

    63046......... Laminectomy, facetectomy 17.25............... 17.25 17.25 No.

    and foraminotomy;

    thoracic.

    657XG......... Implantation of NEW................. 5.93 5.39 No.

    intrastromal corneal

    ring segments.

    68801......... Dilation of tear- 1................... 1 0.82 No.

    drainage opening.

    68810......... Insertion of probe into 2.15................ 1.54 1.54 No.

    the tear duct.

    68811......... Insertion of probe into 2.45................ 2.03 1.74 No.

    the tear duct under

    anesthesia.

    68815......... Probing of nasal-tear 3.3................. 3 2.7 No.

    duct with insertion of

    tube or stent.

    68816......... Probing of nasal-tear 3.06................ 2.35 2.1 No.

    duct with balloon

    catheter dilation.

    71100......... Radiologic examination, 0.22................ 0.22 0.22 No.

    ribs, unilateral; 2

    views.

    72070......... Radiologic examination, 0.22................ 0.22 0.22 No.

    spine; thoracic, 2

    views.

    7208A......... Entire spine x ray, one NEW................. 0.3 0.26 No.

    view.

    7208B......... Entire spine x-ray; 2 or NEW................. 0.35 0.31 No.

    3 views.

    7208C......... Entire spine x-ray; 4 or NEW................. 0.39 0.35 No.

    5 views.

    7208D......... Entire spine x-ray; min NEW................. 0.45 0.41 No.

    6 views.

    73060......... Radiologic examination; 0.17................ 0.16 0.16 No.

    humerus, minimum of 2

    views.

    73560......... Radiologic examination, 0.17................ 0.16 0.16 No.

    knee; 1 or 2 views.

    73562......... Radiologic examination, 0.18................ 0.18 0.18 No.

    knee; 3 views.

    73564......... Radiologic examination, 0.22................ 0.22 0.22 No.

    knee; complete, 4 or

    more views.

    73565......... Radiologic examination, 0.17................ 0.16 0.16 No.

    knee; both knees,

    standing,

    anteroposterior.

    73590......... Radiologic examination; 0.17................ 0.16 0.16 No.

    tibia and fibula, 2

    views.

    73600......... Radiologic examination, 0.16................ 0.16 0.16 No.

    ankle; 2 views.

    76999......... Ultrasound procedure.... C................... C C N/A

    77387......... Guidance for N/A................. 0.58 0.58 No.

    localization of target

    volume for delivery of

    radiation treatment

    delivery, includes

    intrafraction tracking

    when performed.

    7778B......... Remote afterloading high NEW................. 1.4 1.4 No.

    dose rate radionuclide

    skin surface

    brachytherapy, includes

    basic dosimetry, when

    performed; lesion

    diameter over 2.0 cm

    and 2 or more channels,

    or multiple lesions.

    7778C......... Remote afterloading high NEW................. 1.95 1.95 No.

    dose rate radionuclide

    interstitial or

    intracavitary

    brachytherapy, includes

    basic dosimetry, when

    performed; 1 channel.

    7778D......... Remote afterloading high NEW................. 3.8 3.8 No.

    dose rate radionuclide

    interstitial or

    intracavitary

    brachytherapy, includes

    basic dosimetry, when

    performed; 2-12

    channels.

    7778E......... Remote afterloading high NEW................. 5.4 5.4 No.

    dose rate radionuclide

    interstitial or

    intracavitary

    brachytherapy, includes

    basic dosimetry, when

    performed; over 12

    channels.

    88346......... Antibody evaluation..... 0.86................ 0.74 0.56 No.

    8835X......... Immunofluorescence, per NEW................. 0.7 0.53 No.

    specimen; each

    additional single

    antibody stain

    procedure (List

    separately in addition

    to code for primary

    procedure).

    88367......... Morphometric analysis, 0.73................ 0.86 0.73 No.

    in situ hybridization

    (quantitative or semi-

    quantitative), using

    computer-assisted

    technology, per

    specimen: initial

    single probe stain

    procedure.

    88368......... Morphometric analysis, 0.88................ 0.88 0.88 No.

    in situ hybridization

    (quantitative or semi-

    quantitative) manual,

    per specimen; initial

    single probe stain

    procedure.

    91299......... Procedure for C................... C C N/A

    gastrointestinal

    diagnosis.

    9254A......... Caloric vestibular test NEW................. 0.8 0.6 No.

    with recording,

    bilateral; bithermal

    (ie, one warm and one

    cool irrigation in each

    ear for a total of four

    irrigations).

    9254B......... Caloric vestibular test NEW................. 0.55 0.3 No.

    with recording,

    bilateral; monothermal

    (ie, one irrigation in

    each ear for a total of

    two irrigations).

    99174......... Instrument-based ocular N................... 0 N No.

    screening (eg,

    photoscreening,

    automated-refraction),

    bilateral.

    9917X......... Instrument-based ocular NEW................. 0 N No.

    screening (eg,

    photoscreening,

    automated-refraction),

    bilateral; with on-site

    analysis.

    G0104......... Colorectal cancer 0.96................ 0.84 0.77 No.

    screening; flexible

    sigmoidoscopy.

    G0105......... Colorectal cancer 3.36................ 3.36 3.29 No.

    screening; colonoscopy

    on individual at high

    risk.

    G0121......... Colorectal cancer 3.36................ 3.36 3.29 No.

    screening; colonoscopy

    on individual not

    meeting criteria for

    high risk.

    ----------------------------------------------------------------------------------------------------------------

    Page 41725

    Table 12--CY 2016 Proposed Codes With Direct PE Input Recommendations

    Accepted Without Refinement

    ------------------------------------------------------------------------

    HCPCS Descriptor

    ------------------------------------------------------------------------

    20245........................... Bone biopsy excisional.

    20697........................... Comp ext fixate strut change.

    27280........................... Fusion of sacroiliac joint.

    3160A........................... Bronch ebus 141 gmt. 141 ng 1/2 node.

    3160B........................... Bronch ebus 141 gmt. 141 ng 3/> node.

    3160C........................... Bronch ebus ivntj perph les.

    31622........................... Dx bronchoscope/wash.

    31625........................... Bronchoscopy w/biopsy(s).

    31626........................... Bronchoscopy w/markers.

    31628........................... Bronchoscopy/lung bx each.

    31629........................... Bronchoscopy/needle bx each.

    31632........................... Bronchoscopy/lung bx addl.

    31633........................... Bronchoscopy/needle bx addl.

    3347A........................... Implant tcat pulm vlv perq.

    37215........................... Transcath stent cca w/eps.

    3725A........................... Intrvasc us noncoronary 1st.

    3725B........................... Intrvasc us noncoronary addl.

    38570........................... Laparoscopy lymph node biop.

    38571........................... Laparoscopy lymphadenectomy.

    3940A........................... Mediastinoscpy w/medstnl bx.

    3940B........................... Mediastinoscpy w/lmph nod bx.

    44384........................... Small bowel endoscopy.

    44402........................... Colonoscopy w/stent plcmt.

    44403........................... Colonoscopy w/resection.

    44406........................... Colonoscopy w/ultrasound.

    44407........................... Colonoscopy w/ndl aspir/bx.

    44408........................... Colonoscopy w/decompression.

    45337........................... Sigmoidoscopy & decompress.

    45341........................... Sigmoidoscopy w/ultrasound.

    45342........................... Sigmoidoscopy w/us guide bx.

    45347........................... Sigmoidoscopy w/plcmt stent.

    45349........................... Sigmoidoscopy w/resection.

    45389........................... Colonoscopy w/stent plcmt.

    45390........................... Colonoscopy w/resection.

    45391........................... Colonoscopy w/endoscope us.

    45392........................... Colonoscopy w/endoscopic fnb.

    45393........................... Colonoscopy w/decompression.

    47135........................... Transplantation of liver.

    5443B........................... Replantation of penis.

    63045........................... Remove spine lamina 1 crvl.

    63046........................... Remove spine lamina 1 thrc.

    68811........................... Probe nasolacrimal duct.

    68815........................... Probe nasolacrimal duct.

    692XX........................... Remove impacted ear wax uni.

    76948........................... Echo guide ova aspiration.

    7778A........................... Hdr rdncl skn surf brachytx.

    7778B........................... Hdr rdncl skn surf brachytx.

    7778C........................... Hdr rdncl ntrstl/icav brchtx.

    7778D........................... Hdr rdncl ntrstl/icav brchtx.

    7778E........................... Hdr rdncl ntrstl/icav brchtx.

    88346........................... Immunofluorescent study.

    8835X........................... Immunofluor antb addl stain.

    9254A........................... Caloric vstblr test w/rec.

    9254B........................... Caloric vstblr test w/rec.

    9935A........................... Prolong clincl staff svc.

    9935B........................... Prolong clincl staff svc add.

    ------------------------------------------------------------------------

    Table 13--CY 2016 Proposed Codes With Direct PE Input Recommendations Accepted With Refinements

    --------------------------------------------------------------------------------------------------------------------------------------------------------

    RUC

    Labor activity recommendation CMS Direct

    HCPCS code HCPCS code Input code Input code NF/F (where or current refinement Comment costs

    description description applicable) value (min or (min or change

    qty) qty) ($)

    --------------------------------------------------------------------------------------------------------------------------------------------------------

    10021...... Fna w/o image..... EF015..... mayo stand....... NF ................. 24 28 Refined equipment ........

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EF023..... table, exam...... NF ................. 29 28 Refined equipment ........

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    L037D..... RN/LPN/MTA....... NF Greet patient, 1 0 Typically billed (0.37)

    provide gowning, with an E/M or

    ensure other evaluation

    appropriate service.

    medical records

    are available.

    11750...... Removal of nail EF015..... mayo stand....... NF ................. 27 45 Refined equipment 0.02

    bed. time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EF031..... table, power..... NF ................. 54 62 Refined equipment 0.13

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EQ137..... instrument pack, NF ................. 34 45 Refined equipment 0.03

    basic ($500- time to conform to

    $1,499). established

    policies for non-

    highly technical

    equipment.

    EQ168..... light, exam...... NF ................. 54 62 Refined equipment 0.03

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    L037D..... RN/LPN/MTA....... NF Provide pre- 0 2 Refined time to 0.74

    service standard time for

    education/obtain this clinical labor

    consent. task.

    SG067..... penrose drain NF ................. 1 0 Removed supply not (0.50)

    (0.25in x 4in). typically used in

    this service.

    11760...... Repair of nail bed EF014..... light, surgical.. NF ................. 45 43 Refined equipment (0.02)

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EF015..... mayo stand....... NF ................. 45 43 Refined equipment ........

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    Page 41726

    EF031..... table, power..... NF ................. 72 70 Refined equipment (0.03)

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EQ137..... instrument pack, NF ................. 52 47 Refined equipment (0.01)

    basic ($500- time to conform to

    $1,499). established

    policies for

    instrument packs.

    EQ168..... light, exam...... NF ................. 72 70 Refined equipment (0.01)

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    L037D..... RN/LPN/MTA....... F Discharge day 6 0 Aligned clinical (2.22)

    management. labor discharge day

    management time

    with the work time

    discharge day code.

    L037D..... RN/LPN/MTA....... NF Complete pre- 5 0 Emergency procedure, (1.85)

    service input would not

    diagnostic & typically be used.

    referral forms.

    L037D..... RN/LPN/MTA....... NF Coordinate pre- 3 0 Emergency procedure, (1.11)

    surgery services. input would not

    typically be used.

    L037D..... RN/LPN/MTA....... NF Provide pre- 5 0 Duplication with (1.85)

    service other clinical

    education/obtain labor task.

    consent.

    12005...... Rpr s/n/a/gen/ EF023..... table, exam...... NF ................. 40 44 Refined equipment 0.01

    trk12.6-20.0cm. time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EQ110..... electrocautery- NF ................. 40 44 Refined equipment 0.01

    hyfrecator, up time to conform to

    to 45 watts. established

    policies for non-

    highly technical

    equipment.

    EQ168..... light, exam...... NF ................. 40 44 Refined equipment 0.02

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    L037D..... RN/LPN/MTA....... F Discharge day 6 0 Aligned clinical (2.22)

    management. labor discharge day

    management time

    with the work time

    discharge day code.

    L037D..... RN/LPN/MTA....... NF Check dressings & 7 3 Refined time to (1.48)

    wound/home care standard time for

    instructions/ this clinical labor

    coordinate task.

    office visits/

    prescriptions.

    12006...... Rpr s/n/a/gen/ EF031..... table, power..... NF ................. 45 49 Refined equipment 0.07

    trk20.1-30.0cm. time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EQ110..... electrocautery- NF ................. 45 49 Refined equipment 0.01

    hyfrecator, up time to conform to

    to 45 watts. established

    policies for non-

    highly technical

    equipment.

    EQ168..... light, exam...... NF ................. 45 49 Refined equipment 0.02

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    L037D..... RN/LPN/MTA....... F Discharge day 6 0 Aligned clinical (2.22)

    management. labor discharge day

    management time

    with the work time

    discharge day code.

    L037D..... RN/LPN/MTA....... NF Check dressings & 7 3 Refined time to (1.48)

    wound/home care standard time for

    instructions/ this clinical labor

    coordinate task.

    office visits/

    prescriptions.

    12007...... Rpr s/n/ax/gen/ EF031..... table, power..... NF ................. 50 54 Refined equipment 0.07

    trnk >30.0 cm. time to conform to

    established

    policies for non-

    highly technical

    equipment.

    Page 41727

    EQ110..... electrocautery- NF ................. 50 54 Refined equipment 0.01

    hyfrecator, up time to conform to

    to 45 watts. established

    policies for non-

    highly technical

    equipment.

    EQ168..... light, exam...... NF ................. 50 54 Refined equipment 0.02

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    L037D..... RN/LPN/MTA....... F Discharge day 6 0 Aligned clinical (2.22)

    management. labor discharge day

    management time

    with the work time

    discharge day code.

    L037D..... RN/LPN/MTA....... NF Check dressings & 7 3 Refined time to (1.48)

    wound/home care standard time for

    instructions/ this clinical labor

    coordinate task.

    office visits/

    prescriptions.

    12013...... Rpr f/e/e/n/l/m EF031..... table, power..... NF ................. 27 33 Refined equipment 0.10

    2.6-5.0 cm. time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EQ110..... electrocautery- NF ................. 27 33 Refined equipment 0.02

    hyfrecator, up time to conform to

    to 45 watts. established

    policies for non-

    highly technical

    equipment.

    EQ168..... light, exam...... NF ................. 27 33 Refined equipment 0.03

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    L037D..... RN/LPN/MTA....... F Discharge day 6 0 Aligned clinical (2.22)

    management. labor discharge day

    management time

    with the work time

    discharge day code.

    L037D..... RN/LPN/MTA....... NF Check dressings & 5 3 Refined time to (0.74)

    wound/home care standard time for

    instructions/ this clinical labor

    coordinate task.

    office visits/

    prescriptions.

    12014...... Rpr f/e/e/n/l/m EF031..... table, power..... NF ................. 32 38 Refined equipment 0.10

    5.1-7.5 cm. time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EQ110..... electrocautery- NF ................. 32 38 Refined equipment 0.02

    hyfrecator, up time to conform to

    to 45 watts. established

    policies for non-

    highly technical

    equipment.

    EQ168..... light, exam...... NF ................. 32 38 Refined equipment 0.03

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    L037D..... RN/LPN/MTA....... F Discharge day 6 0 Aligned clinical (2.22)

    management. labor discharge day

    management time

    with the work time

    discharge day code.

    L037D..... RN/LPN/MTA....... NF Check dressings & 5 3 Refined time to (0.74)

    wound/home care standard time for

    instructions/ this clinical labor

    coordinate task.

    office visits/

    prescriptions.

    12015...... Rpr f/e/e/n/l/m EF031..... table, power..... NF ................. 37 43 Refined equipment 0.10

    7.6-12.5 cm. time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EQ110..... electrocautery- NF ................. 37 43 Refined equipment 0.02

    hyfrecator, up time to conform to

    to 45 watts. established

    policies for non-

    highly technical

    equipment.

    EQ168..... light, exam...... NF ................. 37 43 Refined equipment 0.03

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    Page 41728

    L037D..... RN/LPN/MTA....... F Discharge day 6 0 Aligned clinical (2.22)

    management. labor discharge day

    management time

    with the work time

    discharge day code.

    L037D..... RN/LPN/MTA....... NF Check dressings & 5 3 Refined time to (0.74)

    wound/home care standard time for

    instructions/ this clinical labor

    coordinate task.

    office visits/

    prescriptions.

    12016...... Rpr fe/e/en/l/m EF031..... table, power..... NF ................. 42 48 Refined equipment 0.10

    12.6-20.0 cm. time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EQ110..... electrocautery- NF ................. 42 48 Refined equipment 0.02

    hyfrecator, up time to conform to

    to 45 watts. established

    policies for non-

    highly technical

    equipment.

    EQ168..... light, exam...... NF ................. 42 48 Refined equipment 0.03

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    L037D..... RN/LPN/MTA....... F Discharge day 6 0 Aligned clinical (2.22)

    management. labor discharge day

    management time

    with the work time

    discharge day code.

    L037D..... RN/LPN/MTA....... NF Check dressings & 5 3 Refined time to (0.74)

    wound/home care standard time for

    instructions/ this clinical labor

    coordinate task.

    office visits/

    prescriptions.

    12041...... Intmd rpr n-hf/ ED004..... camera, digital F ................. 0 27 Input added to 0.10

    genit 2.5cm/30.0 cm. (6 mexapixel). time to conform to

    office visit

    duration.

    EF014..... light, surgical.. NF ................. 103 111 Refined equipment 0.08

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EF015..... mayo stand....... NF ................. 103 111 Refined equipment 0.01

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EF023..... table, exam...... NF ................. 166 63 Refined equipment (0.31)

    time to conform to

    office visit

    duration.

    EF031..... table, power..... NF ................. 103 111 Refined equipment 0.13

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EQ110..... electrocautery- NF ................. 103 111 Refined equipment 0.02

    hyfrecator, up time to conform to

    to 45 watts. established

    policies for non-

    highly technical

    equipment.

    EQ138..... instrument pack, NF ................. 115 120 Refined equipment 0.03

    medium ($1,500 time to conform to

    and up). established

    policies for

    instrument packs.

    EQ168..... light, exam...... NF ................. 166 63 Refined equipment (0.45)

    time to conform to

    office visit

    duration.

    L037D..... RN/LPN/MTA....... F Provide pre- 2 0 Intraservice direct (0.74)

    service PE inputs are not

    education/obtain included in the

    consent. facility setting;

    See preamble text.

    L037D..... RN/LPN/MTA....... NF Complete pre- 5 0 Emergency procedure, (1.85)

    service input would not

    diagnostic & typically be used.

    referral forms.

    L037D..... RN/LPN/MTA....... NF Coordinate pre- 3 0 Emergency procedure, (1.11)

    surgery services. input would not

    typically be used.

    L037D..... RN/LPN/MTA....... NF Follow-up phone 3 0 Emergency procedure, (1.11)

    calls and input would not

    prescriptions. typically be used.

    SA054..... pack, post-op F ................. 2 1 No rationale was (4.91)

    incision care provided for

    (suture). quantity change

    relative to current

    value; maintaining

    current value.

    Page 41731

    SA054..... pack, post-op NF ................. 2 1 No rationale was (4.91)

    incision care provided for

    (suture). quantity change

    relative to current

    value; maintaining

    current value.

    20240...... Bone biopsy L037D..... RN/LPN/MTA....... F Dischrg gmt. same 6 0 Aligned clinical (2.22)

    excisional. day (0.5 x labor discharge day

    99238) (enter 6 management time

    min). with the work time

    discharge day code.

    30300...... Remove nasal EF008..... chair with NF ................. 59 67 Refined equipment 0.09

    foreign body. headrest, exam, time to conform to

    reclining. established

    policies for non-

    highly technical

    equipment.

    EF015..... mayo stand....... NF ................. 22 40 Refined equipment 0.02

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EQ137..... instrument pack, NF ................. 29 47 Refined equipment 0.04

    basic ($500- time to conform to

    $1,499). established

    policies for

    instrument packs.

    EQ167..... light source, F ................. 27 0 Redundant when used (0.72)

    xenon. together with

    EQ170; see preamble.

    EQ167..... light source, NF ................. 59 0 Redundant when used (1.57)

    xenon. together with

    EQ170; see preamble.

    EQ170..... light, fiberoptic NF ................. 59 67 Refined equipment 0.06

    headlight w- time to conform to

    source. established

    policies for non-

    highly technical

    equipment.

    EQ234..... suction and NF ................. 59 67 Refined equipment 0.07

    pressure time to conform to

    cabinet, ENT established

    (SMR). policies for non-

    highly technical

    equipment.

    ES013..... endoscope, rigid, NF ................. 71 74 Refined equipment 0.02

    sinoscopy. time to conform to

    established

    policies for scopes.

    ES031..... video system, NF ................. 59 67 Refined equipment 1.03

    endoscopy time to conform to

    (processor, established

    digital capture, policies for non-

    monitor, highly technical

    printer, cart). equipment.

    L037D..... RN/LPN/MTA....... F Discharge day 6 0 Aligned clinical (2.22)

    management. labor discharge day

    management time

    with the work time

    discharge day code.

    SA041..... pack, basic NF ................. 1 0 Supply item replaced (11.67)

    injection. by another item

    (component parts);

    see preamble.

    SB001..... cap, surgical.... NF ................. 0 1 Supply item replaces 0.21

    another item

    (SA041); see

    preamble.

    SB012..... drape, sterile, NF ................. 0 1 Supply item replaces 1.69

    for Mayo stand. another item

    (SA041); see

    preamble.

    SB024..... gloves, sterile.. NF ................. 0 2 Supply item replaces 1.68

    another item

    (SA041); see

    preamble.

    SB027..... gown, staff, NF ................. 0 2 Supply item replaces 2.37

    impervious. another item

    (SA041); see

    preamble.

    SB033..... mask, surgical... NF ................. 0 1 Supply item replaces 0.20

    another item

    (SA041); see

    preamble.

    SB044..... underpad 2ft x NF ................. 0 1 Supply item replaces 0.23

    3ft (Chux). another item

    (SA041); see

    preamble.

    SG009..... applicator, NF ................. 0 3 Supply item replaces 0.42

    sponge-tipped. another item

    (SA041); see

    preamble.

    SG055..... gauze, sterile NF ................. 0 2 Supply item replaces 0.32

    4in x 4in. another item

    (SA041); see

    preamble.

    SM010..... cleaning brush, F ................. 2 1 Refined supply (4.99)

    endoscope. quantity to what is

    typical for the

    procedure.

    Page 41732

    SM010..... cleaning brush, NF ................. 4 2 Refined supply (9.98)

    endoscope. quantity to what is

    typical for the

    procedure.

    30903...... Control of EF008..... chair with NF ................. 54 110 Refined equipment 0.60

    nosebleed. headrest, exam, time to conform to

    reclining. established

    policies for

    equipment with 4x

    monitoring time.

    EQ110..... electrocautery- NF ................. 54 50 Refined equipment (0.01)

    hyfrecator, up time to conform to

    to 45 watts. established

    policies for non-

    highly technical

    equipment.

    EQ137..... instrument pack, NF ................. 61 54 Refined equipment (0.02)

    basic ($500- time to conform to

    $1,499). established

    policies for

    instrument packs.

    EQ170..... light, fiberoptic NF ................. 54 50 Refined equipment (0.03)

    headlight w- time to conform to

    source. established

    policies for non-

    highly technical

    equipment.

    EQ234..... suction and NF ................. 54 110 Refined equipment 0.52

    pressure time to conform to

    cabinet, ENT established

    (SMR). policies for

    equipment with 4x

    monitoring time.

    L037D..... RN/LPN/MTA....... F Dischrg gmt. same 6 0 Aligned clinical (2.22)

    day (0.5 x labor discharge day

    99238) (enter 6 management time

    min). with the work time

    discharge day code.

    30905...... Control of EF008..... chair with NF ................. 72 128 Refined equipment 0.60

    nosebleed. headrest, exam, time to conform to

    reclining. established

    policies for

    equipment with 4x

    monitoring time.

    EQ110..... electrocautery- NF ................. 72 68 Refined equipment (0.01)

    hyfrecator, up time to conform to

    to 45 watts. established

    policies for non-

    highly technical

    equipment.

    EQ137..... instrument pack, NF ................. 79 72 Refined equipment (0.02)

    basic ($500- time to conform to

    $1,499). established

    policies for

    instrument packs.

    EQ170..... light, fiberoptic NF ................. 72 68 Refined equipment (0.03)

    headlight w- time to conform to

    source. established

    policies for non-

    highly technical

    equipment.

    EQ234..... suction and NF ................. 72 128 Refined equipment 0.52

    pressure time to conform to

    cabinet, ENT established

    (SMR). policies for

    equipment with 4x

    monitoring time.

    L037D..... RN/LPN/MTA....... F Dischrg gmt. same 6 0 Aligned clinical (2.22)

    day (0.5 x labor discharge day

    99238) (enter 6 management time

    min). with the work time

    discharge day code.

    30906...... Repeat control of EF008..... chair with NF ................. 84 140 Refined equipment 0.60

    nosebleed. headrest, exam, time to conform to

    reclining. established

    policies for

    equipment with 4x

    monitoring time.

    EQ110..... electrocautery- NF ................. 84 80 Refined equipment (0.01)

    hyfrecator, up time to conform to

    to 45 watts. established

    policies for non-

    highly technical

    equipment.

    EQ137..... instrument pack, NF ................. 91 84 Refined equipment (0.02)

    basic ($500- time to conform to

    $1,499). established

    policies for

    instrument packs.

    EQ170..... light, fiberoptic NF ................. 84 80 Refined equipment (0.03)

    headlight w- time to conform to

    source. established

    policies for non-

    highly technical

    equipment.

    EQ234..... suction and NF ................. 84 140 Refined equipment 0.52

    pressure time to conform to

    cabinet, ENT established

    (SMR). policies for

    equipment with 4x

    monitoring time.

    31295...... Sinus endo w/ EF008..... chair with NF ................. 50 103 Refined equipment 0.57

    balloon dil. headrest, exam, time to conform to

    reclining. established

    policies for

    equipment with 4x

    monitoring time.

    Page 41733

    EF015..... mayo stand....... NF ................. 32 43 Refined equipment 0.01

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EQ137..... instrument pack, NF ................. 42 47 Refined equipment 0.01

    basic ($500- time to conform to

    $1,499). established

    policies for

    instrument packs.

    EQ167..... light source, NF ................. 50 0 Redundant when used (1.33)

    xenon. together with

    EQ170; see preamble.

    EQ170..... light, fiberoptic NF ................. 50 43 Refined equipment (0.06)

    headlight w- time to conform to

    source. established

    policies for non-

    highly technical

    equipment.

    EQ234..... suction and NF ................. 50 103 Refined equipment 0.49

    pressure time to conform to

    cabinet, ENT established

    (SMR). policies for

    equipment with 4x

    monitoring time.

    ES013..... endoscope, rigid, NF ................. 44 47 Refined equipment 0.02

    sinoscopy. time to conform to

    established

    policies for scopes.

    ES031..... video system, NF ................. 50 43 Refined equipment (0.90)

    endoscopy time to conform to

    (processor, established

    digital capture, policies for non-

    monitor, highly technical

    printer, cart). equipment.

    L037D..... RN/LPN/MTA....... F Dischrg gmt. same 6 0 Aligned clinical (2.22)

    day (0.5 x labor discharge day

    99238) (enter 6 management time

    min). with the work time

    discharge day code.

    L037D..... RN/LPN/MTA....... NF Complete pre- 5 0 See preamble text... (1.85)

    service

    diagnostic &

    referral forms.

    L037D..... RN/LPN/MTA....... NF Provide pre- 7 3 Refined time to (1.48)

    service standard time for

    education/obtain this clinical labor

    consent. task.

    L037D..... RN/LPN/MTA....... NF Sedate/Apply 5 2 Refined time to (1.11)

    anesthesia. standard time for

    this clinical labor

    task.

    SJ037..... oxymetazoline NF ................. 3 1 Refined supply (3.66)

    nasal spray quantity to what is

    (Afrin) (15ml typical for the

    uou). procedure.

    31296...... Sinus endo w/ EF008..... chair with NF ................. 60 113 Refined equipment 0.57

    balloon dil. headrest, exam, time to conform to

    reclining. established

    policies for

    equipment with 4x

    monitoring time.

    EF015..... mayo stand....... NF ................. 60 53 Refined equipment (0.01)

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EQ137..... instrument pack, NF ................. 52 57 Refined equipment 0.01

    basic ($500- time to conform to

    $1,499). established

    policies for

    instrument packs.

    EQ167..... light source, NF ................. 60 0 Redundant when used (1.60)

    xenon. together with

    EQ170; see preamble.

    EQ170..... light, fiberoptic NF ................. 60 53 Refined equipment (0.06)

    headlight w- time to conform to

    source. established

    policies for non-

    highly technical

    equipment.

    EQ234..... suction and NF ................. 60 113 Refined equipment 0.49

    pressure time to conform to

    cabinet, ENT established

    (SMR). policies for

    equipment with 4x

    monitoring time.

    ES013..... endoscope, rigid, NF ................. 54 57 Refined equipment 0.02

    sinoscopy. time to conform to

    established

    policies for scopes.

    ES031..... video system, NF ................. 60 53 Refined equipment (0.90)

    endoscopy time to conform to

    (processor, established

    digital capture, policies for non-

    monitor, highly technical

    printer, cart). equipment.

    Page 41734

    L037D..... RN/LPN/MTA....... F Dischrg gmt. same 6 0 Aligned clinical (2.22)

    day (0.5 x labor discharge day

    99238) (enter 6 management time

    min). with the work time

    discharge day code.

    L037D..... RN/LPN/MTA....... NF Complete pre- 5 0 See preamble text... (1.85)

    service

    diagnostic &

    referral forms.

    L037D..... RN/LPN/MTA....... NF Provide pre- 7 3 Refined time to (1.48)

    service standard time for

    education/obtain this clinical labor

    consent. task.

    L037D..... RN/LPN/MTA....... NF Sedate/Apply 5 2 Refined time to (1.11)

    anesthesia. standard time for

    this clinical labor

    task.

    SJ037..... oxymetazoline NF ................. 3 1 Refined supply (3.66)

    nasal spray quantity to what is

    (Afrin) (15ml typical for the

    uou). procedure.

    31297...... Sinus endo w/ EF008..... chair with NF ................. 58 111 Refined equipment 0.57

    balloon dil. headrest, exam, time to conform to

    reclining. established

    policies for

    equipment with 4x

    monitoring time.

    EF015..... mayo stand....... NF ................. 40 51 Refined equipment 0.01

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EQ137..... instrument pack, NF ................. 47 55 Refined equipment 0.02

    basic ($500- time to conform to

    $1,499). established

    policies for

    instrument packs.

    EQ167..... light source, NF ................. 58 0 Redundant when used (1.55)

    xenon. together with

    EQ170; see preamble.

    EQ170..... light, fiberoptic NF ................. 58 51 Refined equipment (0.06)

    headlight w- time to conform to

    source. established

    policies for non-

    highly technical

    equipment.

    EQ234..... suction and NF ................. 58 111 Refined equipment 0.49

    pressure time to conform to

    cabinet, ENT established

    (SMR). policies for

    equipment with 4x

    monitoring time.

    ES013..... endoscope, rigid, NF ................. 52 55 Refined equipment 0.02

    sinoscopy. time to conform to

    established

    policies for scopes.

    ES031..... video system, NF ................. 58 51 Refined equipment (0.90)

    endoscopy time to conform to

    (processor, established

    digital capture, policies for non-

    monitor, highly technical

    printer, cart). equipment.

    L037D..... RN/LPN/MTA....... F Dischrg gmt. same 6 0 Aligned clinical (2.22)

    day (0.5 x labor discharge day

    99238) (enter 6 management time

    min). with the work time

    discharge day code.

    L037D..... RN/LPN/MTA....... NF Complete pre- 5 0 See preamble text... (1.85)

    service

    diagnostic &

    referral forms.

    L037D..... RN/LPN/MTA....... NF Provide pre- 7 3 Refined time to (1.48)

    service standard time for

    education/obtain this clinical labor

    consent. task.

    L037D..... RN/LPN/MTA....... NF Sedate/Apply 5 2 Refined time to (1.11)

    anesthesia. standard time for

    this clinical labor

    task.

    SJ037..... oxymetazoline NF ................. 3 1 Refined supply (3.66)

    nasal spray quantity to what is

    (Afrin) (15ml typical for the

    uou). procedure.

    38572...... Laparoscopy SA051..... pack, pelvic exam F ................. 1 0 Removed supply not (1.17)

    lymphadenectomy. typically used in

    this service.

    40804...... Removal foreign EF008..... chair with NF ................. 74 82 Refined equipment 0.09

    body mouth. headrest, exam, time to conform to

    reclining. established

    policies for non-

    highly technical

    equipment.

    EQ110..... electrocautery- NF ................. 29 39 Refined equipment 0.03

    hyfrecator, up time to conform to

    to 45 watts. established

    policies for non-

    highly technical

    equipment.

    Page 41735

    EQ137..... instrument pack, NF ................. 36 38 Refined equipment --

    basic ($500- time to conform to

    $1,499). established

    policies for

    instrument packs.

    EQ170..... light, fiberoptic NF ................. 74 82 Refined equipment 0.06

    headlight w- time to conform to

    source. established

    policies for non-

    highly technical

    equipment.

    EQ234..... suction and F ................. 27 0 Equipment usage not (0.25)

    pressure typical for a

    cabinet, ENT follow-up office

    (SMR). visit.

    EQ234..... suction and NF ................. 61 39 Refined equipment (0.20)

    pressure time to conform to

    cabinet, ENT established

    (SMR). policies for non-

    highly technical

    equipment.

    L037D..... RN/LPN/MTA....... F Dischrg gmt. same 6 0 Aligned clinical (2.22)

    day (0.5 x labor discharge day

    99238) (enter 6 management time

    min). with the work time

    discharge day code.

    SD009..... canister, suction NF ................. 2 1 Refined supply (3.91)

    quantity to what is

    typical for the

    procedure.

    42809...... Remove pharynx EF008..... chair with NF ................. 58 74 Refined equipment 0.17

    foreign body. headrest, exam, time to conform to

    reclining. established

    policies for non-

    highly technical

    equipment.

    EF015..... mayo stand....... NF ................. 26 47 Refined equipment 0.02

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EQ137..... instrument pack, NF ................. 60 51 Refined equipment (0.02)

    basic ($500- time to conform to

    $1,499). established

    policies for

    instrument packs.

    EQ170..... light, fiberoptic NF ................. 58 74 Refined equipment 0.13

    headlight w- time to conform to

    source. established

    policies for non-

    highly technical

    equipment.

    EQ234..... suction and F ................. 27 0 Equipment usage not (0.25)

    pressure typical for a

    cabinet, ENT follow-up office

    (SMR). visit.

    EQ234..... suction and NF ................. 58 47 Refined equipment (0.10)

    pressure time to conform to

    cabinet, ENT established

    (SMR). policies for non-

    highly technical

    equipment.

    ES020..... fiberscope, NF ................. 115 128 Refined equipment 0.47

    flexible, time to conform to

    rhinolaryngoscop established

    y. policies for scopes.

    L037D..... RN/LPN/MTA....... F Dischrg gmt. same 6 0 Aligned clinical (2.22)

    day (0.5 x labor discharge day

    99238) (enter 6 management time

    min). with the work time

    discharge day code.

    SA048..... pack, minimum F ................. 2 1 Refined supply (1.14)

    multi-specialty quantity to what is

    visit. typical for the

    procedure.

    44380...... Small bowel EF018..... stretcher........ NF ................. 73 77 Standard time for 0.02

    endoscopy br/wa. moderate sedation

    equipment.

    EF027..... table, NF ................. 29 77 Standard time for 0.07

    instrument, moderate sedation

    mobile. equipment.

    EF031..... table, power..... NF ................. 29 0 Equipment removed (0.47)

    due to redundancy

    when used together

    with equipment item

    EF018, stretcher.

    EQ011..... ECG, 3-channel NF ................. 52 77 Standard time for 0.35

    (with SpO2, moderate sedation

    NIBP, temp, equipment.

    resp).

    EQ032..... IV infusion pump. NF ................. 52 77 Standard time for 0.16

    moderate sedation

    equipment.

    44381...... Small bowel EF018..... stretcher........ NF ................. 83 87 Standard equipment 0.02

    endoscopy br/wa. and time for

    moderate sedation.

    EF027..... table, NF ................. 39 87 Standard equipment 0.07

    instrument, and time for

    mobile. moderate sedation.

    EQ011..... ECG, 3-channel NF ................. 62 87 Standard equipment 0.35

    (with SpO2, and time for

    NIBP, temp, moderate sedation.

    resp).

    Page 41736

    EQ032..... IV infusion pump. NF ................. 62 87 Standard equipment 0.16

    and time for

    moderate sedation.

    44382...... Small bowel EF018..... stretcher........ NF ................. 78 82 Standard time for 0.02

    endoscopy. moderate sedation

    equipment.

    EF027..... table, NF ................. 34 82 Standard time for 0.07

    instrument, moderate sedation

    mobile. equipment.

    EF031..... table, power..... NF ................. 34 0 Equipment removed (0.56)

    due to redundancy

    when used together

    with equipment item

    EF018, stretcher.

    EQ011..... ECG, 3-channel NF ................. 57 82 Standard time for 0.35

    (with SpO2, moderate sedation

    NIBP, temp, equipment.

    resp).

    EQ032..... IV infusion pump. NF ................. 57 82 Standard time for 0.16

    moderate sedation

    equipment.

    44385...... Endoscopy of bowel EF027..... table, NF ................. 29 77 Standard time for 0.07

    pouch. instrument, moderate sedation

    mobile. equipment.

    EF031..... table, power..... NF ................. 29 0 Equipment removed (0.47)

    due to redundancy

    when used together

    with equipment item

    EF018, stretcher.

    EQ011..... ECG, 3-channel NF ................. 52 77 Refined equipment 0.35

    (with SpO2, time to conform to

    NIBP, temp, established

    resp). policies for

    equipment with 4x

    monitoring time.

    EQ032..... IV infusion pump. NF ................. 52 77 Standard time for 0.16

    moderate sedation

    equipment.

    44386...... Endoscopy bowel EF027..... table, NF ................. 31 79 Standard time for 0.07

    pouch/biop. instrument, moderate sedation

    mobile. equipment.

    EF031..... table, power..... NF ................. 31 0 Equipment removed (0.51)

    due to redundancy

    when used together

    with equipment item

    EF018, stretcher.

    EQ011..... ECG, 3-channel NF ................. 54 79 Standard time for 0.35

    (with SpO2, moderate sedation

    NIBP, temp, equipment.

    resp).

    EQ032..... IV infusion pump. NF ................. 54 79 Standard time for 0.16

    moderate sedation

    equipment.

    44388...... Colonoscopy thru EF027..... table, NF ................. 57 87 Standard time for 0.04

    stoma spx. instrument, moderate sedation

    mobile. equipment.

    EF031..... table, power..... NF ................. 39 0 Equipment removed (0.64)

    due to redundancy

    when used together

    with equipment item

    EF018, stretcher.

    EQ011..... ECG, 3-channel NF ................. 57 87 Standard time for 0.42

    (with SpO2, moderate sedation

    NIBP, temp, equipment.

    resp).

    EQ032..... IV infusion pump. NF ................. 57 87 Standard time for 0.19

    moderate sedation

    equipment.

    44389...... Colonoscopy with EF027..... table, NF ................. 62 92 Standard time for 0.04

    biopsy. instrument, moderate sedation

    mobile. equipment.

    EF031..... table, power..... NF ................. 44 0 Equipment removed (0.72)

    due to redundancy

    when used together

    with equipment item

    EF018, stretcher.

    EQ011..... ECG, 3-channel NF ................. 62 92 Standard time for 0.42

    (with SpO2, moderate sedation

    NIBP, temp, equipment.

    resp).

    EQ032..... IV infusion pump. NF ................. 62 92 Standard time for 0.19

    moderate sedation

    equipment.

    44390...... Colonoscopy for EF027..... table, NF ................. 67 97 Standard time for 0.04

    foreign body. instrument, moderate sedation

    mobile. equipment.

    EF031..... table, power..... NF ................. 49 0 Equipment removed (0.80)

    due to redundancy

    when used together

    with equipment item

    EF018, stretcher.

    Page 41737

    EQ011..... ECG, 3-channel NF ................. 67 97 Standard time for 0.42

    (with SpO2, moderate sedation

    NIBP, temp, equipment.

    resp).

    EQ032..... IV infusion pump. NF ................. 67 97 Standard time for 0.19

    moderate sedation

    equipment.

    44391...... Colonoscopy for EF027..... table, NF ................. 72 102 Standard time for 0.04

    bleeding. instrument, moderate sedation

    mobile. equipment.

    EF031..... table, power..... NF ................. 54 0 Equipment removed (0.88)

    due to redundancy

    when used together

    with equipment item

    EF018, stretcher.

    EQ011..... ECG, 3-channel NF ................. 72 102 Standard time for 0.42

    (with SpO2, moderate sedation

    NIBP, temp, equipment.

    resp).

    EQ032..... IV infusion pump. NF ................. 72 102 Standard time for 0.19

    moderate sedation

    equipment.

    44392...... Colonoscopy & EF027..... table, NF ................. 62 92 Standard time for 0.04

    polypectomy. instrument, moderate sedation

    mobile. equipment.

    EF031..... table, power..... NF ................. 44 0 Equipment removed (0.72)

    due to redundancy

    when used together

    with equipment item

    EF018, stretcher.

    EQ011..... ECG, 3-channel NF ................. 62 92 Standard time for 0.42

    (with SpO2, moderate sedation

    NIBP, temp, equipment.

    resp).

    EQ032..... IV infusion pump. NF ................. 62 92 Standard time for 0.19

    moderate sedation

    equipment.

    44394...... Colonoscopy w/ EF027..... table, NF ................. 62 92 Standard time for 0.04

    snare. instrument, moderate sedation

    mobile. equipment.

    EF031..... table, power..... NF ................. 44 0 Equipment removed (0.72)

    due to redundancy

    when used together

    with equipment item

    EF018, stretcher.

    EQ011..... ECG, 3-channel NF ................. 62 92 Standard time for 0.42

    (with SpO2, moderate sedation

    NIBP, temp, equipment.

    resp).

    EQ032..... IV infusion pump. NF ................. 62 92 Standard time for 0.19

    moderate sedation

    equipment.

    44401...... Colonoscopy with EF027..... table, NF ................. 62 92 Standard equipment 0.04

    ablation. instrument, and time for

    mobile. moderate sedation.

    EF031..... table, power..... NF ................. 44 0 Refined equipment (0.72)

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EQ011..... ECG, 3-channel NF ................. 62 92 Standard equipment 0.42

    (with SpO2, and time for

    NIBP, temp, moderate sedation.

    resp).

    EQ032..... IV infusion pump. NF ................. 62 92 Standard equipment 0.19

    and time for

    moderate sedation.

    44404...... Colonoscopy w/ EF027..... table, NF ................. 62 92 Standard equipment 0.04

    injection. instrument, and time for

    mobile. moderate sedation.

    EQ011..... ECG, 3-channel NF ................. 62 92 Standard equipment 0.42

    (with SpO2, and time for

    NIBP, temp, moderate sedation.

    resp).

    EQ032..... IV infusion pump. NF ................. 62 92 Standard equipment 0.19

    and time for

    moderate sedation.

    44405...... Colonoscopy w/ EF027..... table, NF ................. 40 100 Standard equipment 0.08

    dilation. instrument, and time for

    mobile. moderate sedation.

    EQ011..... ECG, 3-channel NF ................. 50 100 Standard equipment 0.70

    (with SpO2, and time for

    NIBP, temp, moderate sedation.

    resp).

    EQ032..... IV infusion pump. NF ................. 50 100 Standard equipment 0.32

    and time for

    moderate sedation.

    45330...... Diagnostic EF027..... table, NF ................. 12 0 No moderate sedation (0.02)

    sigmoidoscopy. instrument,

    mobile.

    Page 41738

    EQ011..... ECG, 3-channel NF ................. 18 0 No moderate sedation (0.25)

    (with SpO2,

    NIBP, temp,

    resp).

    EQ235..... suction machine NF ................. 12 22 Increased to reflect 0.02

    (Gomco). Intra-Service

    clinical labor

    tasks.

    ES031..... video system, NF ................. 12 22 Increased to reflect 1.29

    endoscopy Intra-Service

    (processor, clinical labor

    digital capture, tasks.

    monitor,

    printer, cart).

    ES043..... Video Sigmoid- NF ................. 42 49 Refined equipment 0.49

    oscope. time to conform to

    established

    policies for scopes.

    45331...... Sigmoidoscopy and EF027..... table, NF ................. 12 0 No moderate sedation (0.02)

    biopsy. instrument,

    mobile.

    EQ011..... ECG, 3-channel NF ................. 33 0 No moderate sedation (0.46)

    (with SpO2,

    NIBP, temp,

    resp).

    EQ235..... suction machine NF ................. 12 27 Matches time spent 0.03

    (Gomco). using endoscope

    system.

    ES031..... video system, NF ................. 12 27 Increased to reflect 1.93

    endoscopy Intra-Service

    (processor, clinical labor

    digital capture, tasks.

    monitor,

    printer, cart).

    ES043..... Video Sigmoid- NF ................. 42 54 Refined equipment 0.83

    oscope. time to conform to

    established

    policies for scopes.

    45332...... Sigmoidoscopy w/fb EF027..... table, NF ................. 34 82 Standard time for 0.07

    removal. instrument, moderate sedation

    mobile. equipment.

    EF031..... table, power..... NF ................. 34 0 Equipment removed (0.56)

    due to redundancy

    when used together

    with equipment item

    EF018, stretcher.

    EQ011..... ECG, 3-channel NF ................. 57 82 Standard time for 0.35

    (with SpO2, moderate sedation

    NIBP, temp, equipment.

    resp).

    EQ032..... IV infusion pump. NF ................. 57 82 Standard time for 0.16

    moderate sedation

    equipment.

    45333...... Sigmoidoscopy & EF027..... table, NF ................. 29 77 Standard time for 0.07

    polypectomy. instrument, moderate sedation

    mobile. equipment.

    EF031..... table, power..... NF ................. 29 0 Equipment removed (0.47)

    due to redundancy

    when used together

    with equipment item

    EF018, stretcher.

    EQ011..... ECG, 3-channel NF ................. 52 77 Standard time for 0.35

    (with SpO2, moderate sedation

    NIBP, temp, equipment.

    resp).

    EQ032..... IV infusion pump. NF ................. 52 77 Standard time for 0.16

    moderate sedation

    equipment.

    45334...... Sigmoidoscopy for EF027..... table, NF ................. 34 82 Standard time for 0.07

    bleeding. instrument, moderate sedation

    mobile. equipment.

    EF031..... table, power..... NF ................. 34 0 Equipment removed (0.56)

    due to redundancy

    when used together

    with equipment item

    EF018, stretcher.

    EQ011..... ECG, 3-channel NF ................. 57 82 Standard time for 0.35

    (with SpO2, moderate sedation

    NIBP, temp, equipment.

    resp).

    EQ032..... IV infusion pump. NF ................. 57 82 Standard time for 0.16

    moderate sedation

    equipment.

    45335...... Sigmoidoscopy w/ EF027..... table, NF ................. 29 77 Standard time for 0.07

    submuc inj. instrument, moderate sedation

    mobile. equipment.

    EF031..... table, power..... NF ................. 29 0 Equipment removed (0.47)

    due to redundancy

    when used together

    with equipment item

    EF018, stretcher.

    Page 41739

    EQ011..... ECG, 3-channel NF ................. 52 77 Standard time for 0.35

    (with SpO2, moderate sedation

    NIBP, temp, equipment.

    resp).

    EQ032..... IV infusion pump. NF ................. 52 77 Standard time for 0.16

    moderate sedation

    equipment.

    45338...... Sigmoidoscopy w/ EF027..... table, NF ................. 29 77 Standard time for 0.07

    tumr remove. instrument, moderate sedation

    mobile. equipment.

    EQ011..... ECG, 3-channel NF ................. 52 77 Standard time for 0.35

    (with SpO2, moderate sedation

    NIBP, temp, equipment.

    resp).

    EQ032..... IV infusion pump. NF ................. 52 77 Standard time for 0.16

    moderate sedation

    equipment.

    45340...... Sig w/tndsc EF027..... table, NF ................. 34 82 Standard time for 0.07

    balloon dilation. instrument, moderate sedation

    mobile. equipment.

    EQ011..... ECG, 3-channel NF ................. 57 82 Standard time for 0.35

    (with SpO2, moderate sedation

    NIBP, temp, equipment.

    resp).

    EQ032..... IV infusion pump. NF ................. 57 82 Standard time for 0.16

    moderate sedation

    equipment.

    45346...... Sigmoidoscopy w/ EF027..... table, NF ................. 34 82 Standard equipment 0.07

    ablation. instrument, and time for

    mobile. moderate sedation.

    EQ011..... ECG, 3-channel NF ................. 57 82 Standard equipment 0.35

    (with SpO2, and time for

    NIBP, temp, moderate sedation.

    resp).

    EQ032..... IV infusion pump. NF ................. 57 82 Standard equipment 0.16

    and time for

    moderate sedation.

    45350...... Sgmdsc w/band EF027..... table, NF ................. 94 82 Standard equipment (0.02)

    ligation. instrument, and time for

    mobile. moderate sedation.

    EQ011..... ECG, 3-channel NF ................. 94 82 Standard equipment (0.17)

    (with SpO2, and time for

    NIBP, temp, moderate sedation.

    resp).

    EQ032..... IV infusion pump. NF ................. 94 82 Standard equipment (0.08)

    and time for

    moderate sedation.

    SH074..... water, sterile NF ................. 1 0 This input is not (2.09)

    for irrigation contained within

    (250-1000ml uou). any other code in

    this family;

    maintaining

    consistency with

    all other codes

    within family.

    SK087..... water, distilled. NF ................. 0 5 This input is not 0.07

    contained within

    any other code in

    this family;

    maintaining

    consistency with

    all other codes

    within family.

    45378...... Diagnostic EF027..... table, NF ................. 57 87 Standard time for 0.04

    colonoscopy. instrument, moderate sedation

    mobile. equipment.

    EF031..... table, power..... NF ................. 39 0 Equipment removed (0.64)

    due to redundancy

    when used together

    with equipment item

    EF018, stretcher.

    EQ011..... ECG, 3-channel NF ................. 57 87 Standard time for 0.42

    (with SpO2, moderate sedation

    NIBP, temp, equipment.

    resp).

    EQ032..... IV infusion pump. NF ................. 57 87 Standard time for 0.19

    moderate sedation

    equipment.

    EQ235..... suction machine NF ................. 72 39 Matches time spent (0.07)

    (Gomco). using endoscope

    system.

    45379...... Colonoscopy w/fb EF027..... table, NF ................. 67 97 Standard time for 0.04

    removal. instrument, moderate sedation

    mobile. equipment.

    EF031..... table, power..... NF ................. 49 0 Equipment removed (0.80)

    due to redundancy

    when used together

    with equipment item

    EF018, stretcher.

    EQ011..... ECG, 3-channel NF ................. 67 97 Standard time for 0.42

    (with SpO2, moderate sedation

    NIBP, temp, equipment.

    resp).

    EQ032..... IV infusion pump. NF ................. 67 97 Standard time for 0.19

    moderate sedation

    equipment.

    Page 41740

    EQ235..... suction machine NF ................. 92 49 Matches time spent (0.08)

    (Gomco). using endoscope

    system.

    45380...... Colonoscopy and EF027..... table, NF ................. 60 90 Standard time for 0.04

    biopsy. instrument, moderate sedation

    mobile. equipment.

    EF031..... table, power..... NF ................. 42 0 Equipment removed (0.69)

    due to redundancy

    when used together

    with equipment item

    EF018, stretcher.

    EQ011..... ECG, 3-channel NF ................. 60 90 Standard time for 0.42

    (with SpO2, moderate sedation

    NIBP, temp, equipment.

    resp).

    EQ032..... IV infusion pump. NF ................. 60 90 Standard time for 0.19

    moderate sedation

    equipment.

    EQ235..... suction machine NF ................. 78 42 Matches time spent (0.07)

    (Gomco). using endoscope

    system.

    45381...... Colonoscopy EF027..... table, NF ................. 60 90 Standard time for 0.04

    submucous njx. instrument, moderate sedation

    mobile. equipment.

    EF031..... table, power..... NF ................. 42 0 Equipment removed (0.69)

    due to redundancy

    when used together

    with equipment item

    EF018, stretcher.

    EQ011..... ECG, 3-channel NF ................. 60 90 Standard time for 0.42

    (with SpO2, moderate sedation

    NIBP, temp, equipment.

    resp).

    EQ032..... IV infusion pump. NF ................. 60 90 Standard time for 0.19

    moderate sedation

    equipment.

    EQ235..... suction machine NF ................. 78 42 Matches time spent (0.07)

    (Gomco). using endoscope

    system.

    45382...... Colonoscopy w/ EF027..... table, NF ................. 72 102 Standard time for 0.04

    control bleed. instrument, moderate sedation

    mobile. equipment.

    EF031..... table, power..... NF ................. 54 0 Equipment removed (0.88)

    due to redundancy

    when used together

    with equipment item

    EF018, stretcher.

    EQ011..... ECG, 3-channel NF ................. 72 102 Standard time for 0.42

    (with SpO2, moderate sedation

    NIBP, temp, equipment.

    resp).

    EQ032..... IV infusion pump. NF ................. 72 102 Standard time for 0.19

    moderate sedation

    equipment.

    EQ235..... suction machine NF ................. 102 54 Matches time spent (0.09)

    (Gomco). using endoscope

    system.

    45384...... Colonoscopy w/ EF027..... table, NF ................. 60 90 Standard time for 0.04

    lesion removal. instrument, moderate sedation

    mobile. equipment.

    EF031..... table, power..... NF ................. 42 0 Equipment removed (0.69)

    due to redundancy

    when used together

    with equipment item

    EF018, stretcher.

    EQ011..... ECG, 3-channel NF ................. 60 90 Standard time for 0.42

    (with SpO2, moderate sedation

    NIBP, temp, equipment.

    resp).

    EQ032..... IV infusion pump. NF ................. 60 90 Standard time for 0.19

    moderate sedation

    equipment.

    EQ235..... suction machine NF ................. 78 42 Matches time spent (0.07)

    (Gomco). using endoscope

    system.

    45385...... Colonoscopy w/ EF027..... table, NF ................. 62 92 Standard time for 0.04

    lesion removal. instrument, moderate sedation

    mobile. equipment.

    EF031..... table, power..... NF ................. 44 0 Equipment removed (0.72)

    due to redundancy

    when used together

    with equipment item

    EF018, stretcher.

    EQ011..... ECG, 3-channel NF ................. 62 92 Standard time for 0.42

    (with SpO2, moderate sedation

    NIBP, temp, equipment.

    resp).

    EQ032..... IV infusion pump. NF ................. 62 92 Standard time for 0.19

    moderate sedation

    equipment.

    EQ235..... suction machine NF ................. 82 44 Matches time spent (0.07)

    (Gomco). using endoscope

    system.

    45386...... Colonoscopy w/ EF027..... table, NF ................. 67 97 Standard time for 0.04

    balloon dilat. instrument, moderate sedation

    mobile. equipment.

    Page 41741

    EF031..... table, power..... NF ................. 49 0 Equipment removed (0.80)

    due to redundancy

    when used together

    with equipment item

    EF018, stretcher.

    EQ011..... ECG, 3-channel NF ................. 67 97 Standard time for 0.42

    (with SpO2, moderate sedation

    NIBP, temp, equipment.

    resp).

    EQ032..... IV infusion pump. NF ................. 67 97 Standard time for 0.19

    moderate sedation

    equipment.

    EQ235..... suction machine NF ................. 92 49 Matches time spent (0.08)

    (Gomco). using endoscope

    system.

    45388...... Colonoscopy w/ EF027..... table, NF ................. 67 97 Standard equipment 0.04

    ablation. instrument, and time for

    mobile. moderate sedation.

    EF031..... table, power..... NF ................. 49 0 Refined equipment (0.80)

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EQ011..... ECG, 3-channel NF ................. 67 97 Standard equipment 0.42

    (with SpO2, and time for

    NIBP, temp, moderate sedation.

    resp).

    EQ032..... IV infusion pump. NF ................. 67 97 Standard equipment 0.19

    and time for

    moderate sedation.

    EQ235..... suction machine NF ................. 92 49 Matches time spent (0.08)

    (Gomco). using endoscope

    system.

    45398...... Colonoscopy w/band EF027..... table, NF ................. 52 82 Standard equipment 0.04

    ligation. instrument, and time for

    mobile. moderate sedation.

    EF031..... table, power..... NF ................. 34 0 Refined equipment (0.56)

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EQ011..... ECG, 3-channel NF ................. 52 82 Standard equipment 0.42

    (with SpO2, and time for

    NIBP, temp, moderate sedation.

    resp).

    EQ032..... IV infusion pump. NF ................. 52 82 Standard equipment 0.19

    and time for

    moderate sedation.

    EQ235..... suction machine NF ................. 62 34 Matches time spent (0.06)

    (Gomco). using endoscope

    system.

    46500...... Injection into EF014..... light, surgical.. NF ................. 73 60 Refined equipment (0.13)

    hemorrhoid(s). time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EF031..... table, power..... NF ................. 73 60 Refined equipment (0.21)

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EQ235..... suction machine NF ................. 73 60 Refined equipment (0.03)

    (Gomco). time to conform to

    established

    policies for non-

    highly technical

    equipment.

    ES002..... anoscope with NF ................. 78 60 Refined equipment (0.07)

    light source. time to conform to

    established

    policies for non-

    highly technical

    equipment.

    L037D..... RN/LPN/MTA....... F Cleaning scope at 5 0 Included in clinical (1.85)

    POV. labor task ``Clean

    room, equipment,

    and supplies''

    included in post-

    operative visit.

    L037D..... RN/LPN/MTA....... F Complete pre- 3 0 Standard 0 day (1.11)

    service global pre-service

    diagnostic and times; exception

    referral forms. not accepted as

    service is rarely

    furnished in the

    facility.

    L037D..... RN/LPN/MTA....... F Coordinate pre- 3 0 Standard 0 day (1.11)

    surgery services. global pre-service

    times; exception

    not accepted as

    service is rarely

    furnished in the

    facility.

    L037D..... RN/LPN/MTA....... F Follow-up phone 3 0 Standard 0 day (1.11)

    calls and global pre-service

    prescriptions. times; exception

    not accepted as

    service is rarely

    furnished in the

    facility.

    Page 41742

    L037D..... RN/LPN/MTA....... F Schedule space 3 0 Standard 0 day (1.11)

    and equipment in global pre-service

    facility. times; exception

    not accepted as

    service is rarely

    furnished in the

    facility.

    L037D..... RN/LPN/MTA....... F Setup scope at 5 0 Included in clinical (1.85)

    POV. labor task

    ``Prepare room,

    equipment,

    supplies'' included

    in post-operative

    visit.

    L037D..... RN/LPN/MTA....... NF Clean scope...... 5 0 Included in clinical (1.85)

    labor task ``Clean

    room, equipment,

    and supplies''.

    L037D..... RN/LPN/MTA....... NF Cleaning scope at 5 0 Included in clinical (1.85)

    POV. labor task ``Clean

    room, equipment,

    and supplies''

    included in post-

    operative visit.

    L037D..... RN/LPN/MTA....... NF Follow-up phone 3 0 Typically billed (1.11)

    calls and with an E/M or

    prescriptions. other evaluation

    service.

    L037D..... RN/LPN/MTA....... NF Setup scope (non 5 0 Included in clinical (1.85)

    facility setting labor task

    only). ``Prepare room,

    equipment,

    supplies''.

    L037D..... RN/LPN/MTA....... NF Setup scope at 5 0 Included in clinical (1.85)

    POV. labor task ``Clean

    room, equipment,

    and supplies''

    included in post-

    operative visit.

    SA042..... pack, cleaning NF ................. 2 0 Removed supply (34.12)

    and associated with

    disinfecting, equipment item not

    endoscope. typically used in

    this service.

    46601...... Diagnostic EF031..... table, power..... NF ................. 41 33 Refined equipment (0.13)

    anoscopy. time to conform to

    established

    policies for non-

    highly technical

    equipment.

    46607...... Diagnostic EF031..... table, power..... NF ................. 49 38 Refined equipment (0.18)

    anoscopy & biopsy. time to conform to

    established

    policies for non-

    highly technical

    equipment.

    5039A...... Njx px nfrosgrm &/ ED050..... PACS Workstation NF ................. 58 67 Refined equipment 0.20

    urtrgrm. Proxy. time to conform to

    clinical labor time.

    EF027..... table, NF ................. 284 277 Standard equipment (0.01)

    instrument, and time for

    mobile. moderate sedation.

    EL011..... room, angiography NF ................. 44 0 Equipment item (231.21)

    replaced by another

    item; see preamble.

    EL014..... room, NF ................. 0 44 Equipment item 61.30

    radiographic- replaces another

    fluoroscopic. item; see preamble.

    EQ011..... ECG, 3-channel NF ................. 284 277 Standard equipment (0.10)

    (with SpO2, and time for

    NIBP, temp, moderate sedation.

    resp).

    EQ032..... IV infusion pump. NF ................. 284 277 Standard equipment (0.04)

    and time for

    moderate sedation.

    EQ168..... light, exam...... NF ................. 44 62 Refined equipment 0.08

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    L037D..... RN/LPN/MTA....... NF Monitor pt 0 45 Clinical labor type 16.65

    following replaces another

    service/check clinical labor

    tubes, monitors, type; see preamble.

    drains (not

    related to

    moderate

    sedation).

    L051A..... RN............... NF Monitor pt 45 0 Clinical labor type (22.95)

    following replaced by another

    service/check labor type; see

    tubes, monitors, preamble.

    drains (not

    related to

    moderate

    sedation).

    SA019..... kit, iv starter.. NF ................. 1 0 Duplicative; a (1.60)

    similar item is

    already included in

    this service.

    Page 41743

    SA042..... pack, cleaning NF ................. 1 0 Removed supply (17.06)

    and associated with

    disinfecting, equipment item not

    endoscope. typically used in

    this service.

    SB022..... gloves, non- NF ................. 2 0 Duplicative; items (0.17)

    sterile. included in pack,

    minimum multi-

    specialty visit

    (SA048).

    SB024..... gloves, sterile.. NF ................. 2 1 Duplicative; items (0.84)

    included in pack,

    moderate sedation

    (SA044).

    SB028..... gown, surgical, NF ................. 2 1 Duplicative; items (4.67)

    sterile. included in pack,

    moderate sedation

    (SA044).

    SC049..... stop cock, 3-way. NF ................. 1 0 Duplicative; items (1.18)

    included in pack,

    moderate sedation

    (SA044).

    5039B...... Njx px nfrosgrm &/ ED050..... PACS Workstation NF ................. 21 45 Refined equipment 0.53

    urtrgrm. Proxy. time to conform to

    clinical labor time

    (Full intraservice

    period minus

    monitoring time).

    EF027..... table, NF ................. 22 40 Refined equipment 0.03

    instrument, time to conform to

    mobile. established

    policies for non-

    highly technical

    equipment.

    EL011..... room, angiography NF ................. 22 0 Equipment item (115.60)

    replaced by another

    item; see preamble.

    EL014..... room, NF ................. 0 22 Equipment item 30.65

    radiographic- replaces another

    fluoroscopic. item; see preamble.

    EQ168..... light, exam...... NF ................. 22 40 Refined equipment 0.08

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    L037D..... RN/LPN/MTA....... NF Assist physician 15 0 Removed clinical (5.55)

    in performing labor associated

    procedure. with moderate

    sedation; moderate

    sedation not

    typical for this

    procedure.

    SA042..... pack, cleaning NF ................. 1 0 Removed supply (17.06)

    and associated with

    disinfecting, equipment item not

    endoscope. typically used in

    this service.

    SB001..... cap, surgical.... NF ................. 4 3 Aligned supply (0.21)

    quantities with

    changes to number

    of clinical labor

    staff.

    SB022..... gloves, non- NF ................. 2 0 Duplicative; items (0.17)

    sterile. included in pack,

    minimum multi-

    specialty visit

    (SA048).

    SB033..... mask, surgical... NF ................. 2 1 Aligned supply (0.20)

    quantities with

    changes to number

    of clinical labor

    staff.

    SB039..... shoe covers, NF ................. 4 3 Aligned supply (0.34)

    surgical. quantities with

    changes to number

    of clinical labor

    staff.

    5039C...... Plmt nephrostomy ED050..... PACS Workstation NF ................. 71 80 Refined equipment 0.20

    catheter. Proxy. time to conform to

    clinical labor time.

    EF027..... table, NF ................. 300 290 Standard equipment (0.01)

    instrument, and time for

    mobile. moderate sedation.

    EL011..... room, angiography NF ................. 60 0 Equipment item (315.28)

    replaced by another

    item; see preamble.

    EL014..... room, NF ................. 0 60 Equipment item 83.59

    radiographic- replaces another

    fluoroscopic. item; see preamble.

    EQ011..... ECG, 3-channel NF ................. 300 290 Standard equipment (0.14)

    (with SpO2, and time for

    NIBP, temp, moderate sedation.

    resp).

    EQ032..... IV infusion pump. NF ................. 300 290 Standard equipment (0.06)

    and time for

    moderate sedation.

    EQ168..... light, exam...... NF ................. 60 75 Refined equipment 0.06

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    Page 41744

    L037D..... RN/LPN/MTA....... NF Monitor pt 0 45 Clinical labor type 16.65

    following replaces another

    service/check clinical labor

    tubes, monitors, type; see preamble.

    drains (not

    related to

    moderate

    sedation).

    L041B..... Radiologic NF Clean room/ 6 3 Refined time to (1.23)

    Technologist. equipment by standard time for

    physician staff. this clinical labor

    task.

    L051A..... RN............... NF Monitor pt. 45 0 Clinical labor type (22.95)

    following replaced by another

    service/check labor type; see

    tubes, monitors, preamble.

    drains (not

    related to

    moderate

    sedation).

    SA019..... kit, iv starter.. NF ................. 1 0 Duplicative; items (1.60)

    included in pack,

    moderate sedation

    (SA044).

    SA042..... pack, cleaning NF ................. 1 0 Removed supply (17.06)

    and associated with

    disinfecting, equipment item not

    endoscope. typically used in

    this service.

    SB022..... gloves, non- NF ................. 2 0 Duplicative; items (0.17)

    sterile. included in pack,

    minimum multi-

    specialty visit

    (SA048).

    SB024..... gloves, sterile.. NF ................. 2 1 Duplicative; items (0.84)

    included in pack,

    moderate sedation

    (SA044).

    SB028..... gown, surgical, NF ................. 2 1 Duplicative; items (4.67)

    sterile. included in pack,

    moderate sedation

    (SA044).

    SC049..... stop cock, 3-way. NF ................. 1 0 Duplicative; items (1.18)

    included in pack,

    moderate sedation

    (SA044).

    5039D...... Plmt ED050..... PACS Workstation NF ................. 83 92 Refined equipment 0.20

    nephroureteral Proxy. time to conform to

    catheter. clinical labor time.

    EF027..... table, NF ................. 312 302 Standard equipment (0.01)

    instrument, and time for

    mobile. moderate sedation.

    EL011..... room, angiography NF ................. 72 0 Equipment item (378.34)

    replaced by another

    item; see preamble.

    EL014..... room, NF ................. 0 72 Equipment item 100.30

    radiographic- replaces another

    fluoroscopic. item; see preamble.

    EQ011..... ECG, 3-channel NF ................. 312 302 Standard equipment (0.14)

    (with SpO2, and time for

    NIBP, temp, moderate sedation.

    resp).

    EQ032..... IV infusion pump. NF ................. 312 302 Standard equipment (0.06)

    and time for

    moderate sedation.

    EQ168..... light, exam...... NF ................. 72 87 Refined equipment 0.06

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    L037D..... RN/LPN/MTA....... NF Monitor pt. 0 45 Clinical labor type 16.65

    following replaces another

    service/check clinical labor

    tubes, monitors, type; see preamble.

    drains (not

    related to

    moderate

    sedation).

    L041B..... Radiologic NF Clean room/ 6 3 Refined time to (1.23)

    Technologist. equipment by standard time for

    physician staff. this clinical labor

    task.

    L051A..... RN............... NF Monitor pt. 45 0 Clinical labor type (22.95)

    following replaced by another

    service/check labor type; see

    tubes, monitors, preamble.

    drains (not

    related to

    moderate

    sedation).

    SA019..... kit, iv starter.. NF ................. 1 0 Duplicative; a (1.60)

    similar item is

    already included in

    this service.

    Page 41745

    SA042..... pack, cleaning NF ................. 1 0 Removed supply (17.06)

    and associated with

    disinfecting, equipment item not

    endoscope. typically used in

    this service.

    SB022..... gloves, non- NF ................. 2 0 Duplicative; items (0.17)

    sterile. included in pack,

    minimum multi-

    specialty visit

    (SA048).

    SB024..... gloves, sterile.. NF ................. 2 1 Duplicative; items (0.84)

    included in pack,

    moderate sedation

    (SA044).

    SB028..... gown, surgical, NF ................. 2 1 Duplicative; items (4.67)

    sterile. included in pack,

    moderate sedation

    (SA044).

    SC049..... stop cock, 3-way. NF ................. 1 0 Duplicative; items (1.18)

    included in pack,

    moderate sedation

    (SA044).

    SD306..... Nephroureteral NF ................. 1 0 Supply not mentioned (117.90)

    Catheter. in SOR work

    description.

    5039E...... Exchange ED050..... PACS Workstation NF ................. 21 50 Refined equipment 0.64

    nephrostomy cath. Proxy. time to conform to

    clinical labor time.

    EF027..... table, NF ................. 90 45 Refined equipment (0.06)

    instrument, time to conform to

    mobile. established

    policies for non-

    highly technical

    equipment.

    EL011..... room, angiography NF ................. 30 0 Equipment item (157.64)

    replaced by another

    item; see preamble.

    EL014..... room, NF ................. 0 30 Equipment item 41.79

    radiographic- replaces another

    fluoroscopic. item; see preamble.

    EQ168..... light, exam...... NF ................. 30 45 Refined equipment 0.06

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    L037D..... RN/LPN/MTA....... NF Assist physician 20 0 Clinical labor type (7.40)

    in performing replaced by another

    procedure. labor type; see

    preamble.

    L041B..... Radiologic NF Clean room/ 6 3 Refined time to (1.23)

    Technologist. equipment by standard time for

    physician staff. this clinical labor

    task.

    SA031..... kit, suture NF ................. 1 0 Redundant when used (1.05)

    removal. together with

    supply catheter

    percutaneous

    fastener (Percu--

    Stay) (SD146).

    SA042..... pack, cleaning NF ................. 1 0 Removed supply (17.06)

    and associated with

    disinfecting, equipment item not

    endoscope. typically used in

    this service.

    SB001..... cap, surgical.... NF ................. 4 3 Aligned supply (0.21)

    quantities with

    changes to number

    of clinical labor

    staff.

    SB022..... gloves, non- NF ................. 2 0 Duplicative; items (0.17)

    sterile. included in pack,

    minimum multi-

    specialty visit

    (SA048).

    SB033..... mask, surgical... NF ................. 2 1 Aligned supply (0.20)

    quantities with

    changes to number

    of clinical labor

    staff.

    SB039..... shoe covers, NF ................. 4 3 Aligned supply (0.34)

    surgical. quantities with

    changes to number

    of clinical labor

    staff.

    5039M...... Convert ED050..... PACS Workstation NF ................. 68 77 Refined equipment 0.20

    nephrostomy Proxy. time to conform to

    catheter. clinical labor time.

    EF027..... table, NF ................. 297 287 Standard equipment (0.01)

    instrument, and time for

    mobile. moderate sedation.

    EL011..... room, angiography NF ................. 57 0 Equipment item (299.52)

    replaced by another

    item; see preamble.

    EL014..... room, NF ................. 0 57 Equipment item 79.41

    radiographic- replaces another

    fluoroscopic. item; see preamble.

    EQ011..... ECG, 3-channel NF ................. 297 287 Standard equipment (0.14)

    (with SpO2, and time for

    NIBP, temp, moderate sedation.

    resp).

    EQ032..... IV infusion pump. NF ................. 297 287 Standard equipment (0.06)

    and time for

    moderate sedation.

    Page 41746

    EQ168..... light, exam...... NF ................. 57 72 Refined equipment 0.06

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    L037D..... RN/LPN/MTA....... NF Monitor pt 0 45 Clinical labor type 16.65

    following replaces another

    service/check clinical labor

    tubes, monitors, type; see preamble.

    drains (not

    related to

    moderate

    sedation).

    L041B..... Radiologic NF Clean room/ 6 3 Refined time to (1.23)

    Technologist. equipment by standard time for

    physician staff. this clinical labor

    task.

    L051A..... RN............... NF Monitor pt 45 0 Clinical labor type (22.95)

    following replaced by another

    service/check labor type; see

    tubes, monitors, preamble.

    drains (not

    related to

    moderate

    sedation).

    SA019..... kit, iv starter.. NF ................. 1 0 Duplicative; items (1.60)

    included in pack,

    moderate sedation

    (SA044).

    SA031..... kit, suture NF ................. 1 0 Redundant when used (1.05)

    removal. together with

    supply catheter

    percutaneous

    fastener (Percu--

    Stay) (SD146).

    SA042..... pack, cleaning NF ................. 1 0 Removed supply (17.06)

    and associated with

    disinfecting, equipment item not

    endoscope. typically used in

    this service.

    SB022..... gloves, non- NF ................. 2 0 Duplicative; items (0.17)

    sterile. included in pack,

    minimum multi-

    specialty visit

    (SA048).

    SB024..... gloves, sterile.. NF ................. 2 1 Duplicative; items (0.84)

    included in pack,

    moderate sedation

    (SA044).

    SB028..... gown, surgical, NF ................. 2 1 Duplicative; items (4.67)

    sterile. included in pack,

    moderate sedation

    (SA044).

    SC049..... stop cock, 3-way. NF ................. 1 0 Duplicative; items (1.18)

    included in pack,

    moderate sedation

    (SA044).

    5069G...... Plmt ureteral ED050..... PACS Workstation NF ................. 68 77 Refined equipment 0.20

    stent prq. Proxy. time to conform to

    clinical labor time.

    EF027..... table, NF ................. 297 287 Standard equipment (0.01)

    instrument, and time for

    mobile. moderate sedation.

    EL011..... room, angiography NF ................. 57 0 Equipment item (299.52)

    replaced by another

    item; see preamble.

    EL014..... room, NF ................. 0 57 Equipment item 79.41

    radiographic- replaces another

    fluoroscopic. item; see preamble.

    EQ011..... ECG, 3-channel NF ................. 297 287 Standard equipment (0.14)

    (with SpO2, and time for

    NIBP, temp, moderate sedation.

    resp).

    EQ032..... IV infusion pump. NF ................. 297 287 Standard equipment (0.06)

    and time for

    moderate sedation.

    EQ168..... light, exam...... NF ................. 57 72 Refined equipment 0.06

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    L037D..... RN/LPN/MTA....... NF Monitor pt. 0 45 Clinical labor type 16.65

    following replaces another

    service/check clinical labor

    tubes, monitors, type; see preamble.

    drains (not

    related to

    moderate

    sedation).

    L041B..... Radiologic NF Clean room/ 6 3 Refined time to (1.23)

    Technologist. equipment by standard time for

    physician staff. this clinical labor

    task.

    Page 41747

    L051A..... RN............... NF Monitor pt. 45 0 Clinical labor type (22.95)

    following replaced by another

    service/check labor type; see

    tubes, monitors, preamble.

    drains (not

    related to

    moderate

    sedation).

    SA019..... kit, iv starter.. NF ................. 1 0 Duplicative; items (1.60)

    included in pack,

    moderate sedation

    (SA044).

    SA031..... kit, suture NF ................. 1 0 Redundant when used (1.05)

    removal. together with

    supply catheter

    percutaneous

    fastener (Percu--

    Stay) (SD146).

    SA042..... pack, cleaning NF ................. 1 0 Removed supply (17.06)

    and associated with

    disinfecting, equipment item not

    endoscope. typically used in

    this service.

    SB022..... gloves, non- NF ................. 2 0 Duplicative; items (0.17)

    sterile. included in pack,

    minimum multi-

    specialty visit

    (SA048).

    SB024..... gloves, sterile.. NF ................. 2 1 Duplicative; items (0.84)

    included in pack,

    moderate sedation

    (SA044).

    SB028..... gown, surgical, NF ................. 2 1 Duplicative; items (4.67)

    sterile. included in pack,

    moderate sedation

    (SA044).

    SC049..... stop cock, 3-way. NF ................. 1 0 Duplicative; items (1.18)

    included in pack,

    moderate sedation

    (SA044).

    5069H...... Plmt ureteral ED050..... PACS Workstation NF ................. 85 94 Refined equipment 0.20

    stent prq. Proxy. time to conform to

    clinical labor time.

    EF027..... table, NF ................. 314 304 Standard equipment (0.01)

    instrument, and time for

    mobile. moderate sedation.

    EL011..... room, angiography NF ................. 74 0 Equipment item (388.85)

    replaced by another

    item; see preamble.

    EL014..... room, NF ................. 0 74 Equipment item 103.09

    radiographic- replaces another

    fluoroscopic. item; see preamble.

    EQ011..... ECG, 3-channel NF ................. 314 304 Standard equipment (0.14)

    (with SpO2, and time for

    NIBP, temp, moderate sedation.

    resp).

    EQ032..... IV infusion pump. NF ................. 314 304 Standard equipment (0.06)

    and time for

    moderate sedation.

    EQ168..... light, exam...... NF ................. 74 89 Refined equipment 0.06

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    L037D..... RN/LPN/MTA....... NF Monitor pt. 0 45 Clinical labor type 16.65

    following replaces another

    service/check clinical labor

    tubes, monitors, type; see preamble.

    drains (not

    related to

    moderate

    sedation).

    L041B..... Radiologic NF Acquire images 47 46 Rounding error in CL (0.41)

    Technologist. (75%). time calculation.

    L041B..... Radiologic NF Clean room/ 6 3 Refined time to (1.23)

    Technologist. equipment by standard time for

    physician staff. this clinical labor

    task.

    L051A..... RN............... NF Monitor pt. 45 0 Clinical labor type (22.95)

    following replaced by another

    service/check labor type; see

    tubes, monitors, preamble.

    drains (not

    related to

    moderate

    sedation).

    SA019..... kit, iv starter.. NF ................. 1 0 Duplicative; items (1.60)

    included in pack,

    moderate sedation

    (SA044).

    SA042..... pack, cleaning NF ................. 1 0 Removed supply (17.06)

    and associated with

    disinfecting, equipment item not

    endoscope. typically used in

    this service.

    Page 41748

    SB022..... gloves, non- NF ................. 2 0 Duplicative; items (0.17)

    sterile. included in pack,

    minimum multi-

    specialty visit

    (SA048).

    SB024..... gloves, sterile.. NF ................. 2 1 Duplicative; items (0.84)

    included in pack,

    moderate sedation

    (SA044).

    SB028..... gown, surgical, NF ................. 2 1 Duplicative; a (4.67)

    sterile. similar item is

    already included in

    this service.

    SC049..... stop cock, 3-way. NF ................. 1 0 Duplicative; items (1.18)

    included in pack,

    moderate sedation

    (SA044).

    5069I...... Plmt ureteral ED050..... PACS Workstation NF ................. 98 107 Refined equipment 0.20

    stent prq. Proxy. time to conform to

    clinical labor time.

    EF027..... table, NF ................. 327 317 Standard equipment (0.01)

    instrument, and time for

    mobile. moderate sedation.

    EL011..... room, angiography NF ................. 87 0 Equipment item (457.16)

    replaced by another

    item; see preamble.

    EL014..... room, NF ................. 0 87 Equipment item 121.20

    radiographic- replaces another

    fluoroscopic. item; see preamble.

    EQ011..... ECG, 3-channel NF ................. 327 317 Standard equipment (0.14)

    (with SpO2, and time for

    NIBP, temp, moderate sedation.

    resp).

    EQ032..... IV infusion pump. NF ................. 327 317 Standard equipment (0.06)

    and time for

    moderate sedation.

    EQ168..... light, exam...... NF ................. 87 102 Refined equipment 0.06

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    L037D..... RN/LPN/MTA....... NF Monitor pt. 0 45 Clinical labor type 16.65

    following replaces another

    service/check clinical labor

    tubes, monitors, type; see preamble.

    drains (not

    related to

    moderate

    sedation).

    L041B..... Radiologic NF Clean room/ 6 3 Refined time to (1.23)

    Technologist. equipment by standard time for

    physician staff. this clinical labor

    task.

    L051A..... RN............... NF Monitor pt. 45 0 Clinical labor type (22.95)

    following replaced by another

    service/check labor type; see

    tubes, monitors, preamble.

    drains (not

    related to

    moderate

    sedation).

    SA019..... kit, iv starter.. NF ................. 1 0 Duplicative; items (1.60)

    included in pack,

    moderate sedation

    (SA044).

    SA042..... pack, cleaning NF ................. 1 0 Removed supply (17.06)

    and associated with

    disinfecting, equipment item not

    endoscope. typically used in

    this service.

    SB022..... gloves, non- NF ................. 2 0 Duplicative; items (0.17)

    sterile. included in pack,

    minimum multi-

    specialty visit

    (SA048).

    SB024..... gloves, sterile.. NF ................. 2 1 Duplicative; items (0.84)

    included in pack,

    moderate sedation

    (SA044).

    SB028..... gown, surgical, NF ................. 2 1 Duplicative; items (4.67)

    sterile. included in pack,

    moderate sedation

    (SA044).

    SC049..... stop cock, 3-way. NF ................. 1 0 Duplicative; items (1.18)

    included in pack,

    moderate sedation

    (SA044).

    5443A...... Repair corporeal EF031..... table, power..... F ................. 144 135 Refined equipment (0.15)

    tear. time to conform to

    clinical labor time.

    EF031..... table, power..... NF ................. 144 135 Refined equipment (0.15)

    time to conform to

    clinical labor time.

    Page 41749

    EQ168..... light, exam...... F ................. 144 135 Refined equipment (0.04)

    time to conform to

    clinical labor time.

    EQ168..... light, exam...... NF ................. 144 135 Refined equipment (0.04)

    time to conform to

    clinical labor time.

    657XG...... Impltj ntrstrml L038A..... COMT/COT/RN/CST.. F Discharge day 6 0 Aligned clinical (2.28)

    crnl rng seg. management same labor discharge day

    day 99238 -6 management time

    minutes. with the work time

    discharge day code.

    68801...... Dilate tear duct L038A..... COMT/COT/RN/CST.. F Discharge day 6 0 Aligned clinical (2.28)

    opening. management same labor discharge day

    day 99238 -6 management time

    minutes. with the work time

    discharge day code.

    68810...... Probe nasolacrimal L038A..... COMT/COT/RN/CST.. F Discharge day 6 0 Aligned clinical (2.28)

    duct. management same labor discharge day

    day 99238 -6 management time

    minutes. with the work time

    discharge day code.

    68816...... Probe nl duct w/ EL006..... lane, screening NF ................. 16 47 Refined equipment 2.77

    balloon. (oph). time to conform to

    clinical labor time.

    69200...... Clear outer ear EF008..... chair with NF ................. 22 27 Refined equipment 0.05

    canal. headrest, exam, time to conform to

    reclining. established

    policies for non-

    highly technical

    equipment.

    EF015..... mayo stand....... NF ................. 19 27 Refined equipment 0.01

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EQ137..... instrument pack, NF ................. 26 31 Refined equipment 0.01

    basic ($500- time to conform to

    $1,499). established

    policies for

    instrument packs.

    EQ170..... light, fiberoptic NF ................. 22 27 Refined equipment 0.04

    headlight w- time to conform to

    source. established

    policies for non-

    highly technical

    equipment.

    EQ183..... microscope, NF ................. 22 27 Refined equipment 0.14

    operating. time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EQ234..... suction and NF ................. 22 27 Refined equipment 0.05

    pressure time to conform to

    cabinet, ENT established

    (SMR). policies for non-

    highly technical

    equipment.

    L037D..... RN/LPN/MTA....... F Dischrg gmt. same 6 0 Aligned clinical (2.22)

    day (0.5 x labor discharge day

    99238) (enter 6 management time

    min). with the work time

    discharge day code.

    SH047..... lidocaine 1%-2% NF ................. 5 0 Supply item replaced (0.18)

    inj (Xylocaine). by another item

    (SH050); see

    preamble.

    SH050..... lidocaine 4% NF ................. 0 3 Supply item replaces 0.46

    soln, topical another item

    (Xylocaine). (SH047); see

    preamble.

    69220...... Clean out mastoid EF008..... chair with NF ................. 20 25 Refined equipment 0.05

    cavity. headrest, exam, time to conform to

    reclining. established

    policies for non-

    highly technical

    equipment.

    EF015..... mayo stand....... NF ................. 17 25 Refined equipment 0.01

    time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EQ137..... instrument pack, NF ................. 0 29 Equipment item 0.07

    basic ($500- replaces another

    $1,499). item (EQ138); see

    preamble.

    EQ138..... instrument pack, NF ................. 29 0 Equipment item (0.20)

    medium ($1,500 replaced by another

    and up). item (EQ137); see

    preamble.

    EQ183..... microscope, NF ................. 20 25 Refined equipment 0.14

    operating. time to conform to

    established

    policies for non-

    highly technical

    equipment.

    Page 41750

    EQ234..... suction and NF ................. 20 25 Refined equipment 0.05

    pressure time to conform to

    cabinet, ENT established

    (SMR). policies for non-

    highly technical

    equipment.

    L037D..... RN/LPN/MTA....... F Dischrg day gmt. 6 0 Aligned clinical (2.22)

    (0.5 x 99238) labor discharge day

    (enter 6 min). management time

    with the work time

    discharge day code.

    L037D..... RN/LPN/MTA....... NF Clean surgical 15 10 Refined time to (1.85)

    instrument standard time for

    package. this clinical labor

    task.

    L037D..... RN/LPN/MTA....... NF Provide pre- 0 2 Refined time to 0.74

    service standard time for

    education/obtain this clinical labor

    consent. task.

    7208A...... X-ray exam entire ED050..... PACS Workstation NF ................. 21 25 Refined equipment 0.09

    spi 1 vw. Proxy. time to conform to

    clinical labor time.

    7208B...... X-ray exam entire ED050..... PACS Workstation NF ................. 36 40 Refined equipment 0.09

    spi 2/3 vw. Proxy. time to conform to

    clinical labor time.

    7208C...... X-ray exam entire ED050..... PACS Workstation NF ................. 44 48 Refined equipment 0.09

    spi 4/5 vw. Proxy. time to conform to

    clinical labor time.

    7208D...... X-ray exam entire ED050..... PACS Workstation NF ................. 53 57 Refined equipment 0.09

    spi 6/ vw. Proxy. time to conform to

    clinical labor time.

    73565...... X-ray exam of L041B..... Radiologic NF Greet patient and 0 3 Input added to 1.23

    knees. Technologist. provide gowning. maintain

    consistency with

    all other codes

    within family.

    77385...... Ntsty modul rad tx EQ139..... intercom (incl. NF ................. 27 0 Indirect Practice (0.10)

    dlvr smpl. master, pt Expense; not

    substation, individually

    power, wiring). allocable to a

    particular patient

    for a particular

    service.

    ER040..... laser, diode, for NF ................. 29 27 Refined equipment (0.12)

    patient time to conform to

    positioning established

    (Probe). policies for highly

    technical equipment.

    ER056..... radiation NF ................. 29 27 Refined equipment (3.15)

    treatment vault. time to conform to

    established

    policies for highly

    technical equipment.

    ER065..... water chiller NF ................. 29 27 Refined equipment (0.13)

    (radiation time to conform to

    treatment). established

    policies for highly

    technical equipment.

    ER089..... IMRT accelerator. NF ................. 29 27 Refined equipment (16.14)

    time to conform to

    established

    policies for highly

    technical equipment.

    ER102..... Power conditioner NF ................. 29 27 Refined equipment (0.17)

    time to conform to

    established

    policies for highly

    technical equipment.

    77386...... Ntsty modul rad tx EQ139..... intercom (incl. NF ................. 42 0 Indirect Practice (0.15)

    dlvr cplx. master, pt Expense; not

    substation, individually

    power, wiring). allocable to a

    particular patient

    for a particular

    service.

    ER040..... laser, diode, for NF ................. 44 42 Refined equipment (0.12)

    patient time to conform to

    positioning established

    (Probe). policies for highly

    technical equipment.

    ER056..... radiation NF ................. 44 42 Refined equipment (3.15)

    treatment vault. time to conform to

    established

    policies for highly

    technical equipment.

    ER065..... water chiller NF ................. 44 42 Refined equipment (0.13)

    (radiation time to conform to

    treatment). established

    policies for highly

    technical equipment.

    ER089..... IMRT accelerator. NF ................. 44 42 Refined equipment (16.14)

    time to conform to

    established

    policies for highly

    technical equipment.

    Page 41751

    ER102..... Power conditioner NF ................. 44 42 Refined equipment (0.17)

    time to conform to

    established

    policies for highly

    technical equipment.

    L050C..... Radiation NF Check dressings & 2 1 Refined to conform (0.50)

    Therapist. wound/home care with identical

    instructions/ labor activity in

    coordinate other codes in the

    office visits/ family.

    prescriptions.

    77402...... Radiation EQ139..... intercom (incl. NF ................. 12 0 Indirect Practice (0.04)

    treatment master, pt Expense; not

    delivery. substation, individually

    power, wiring). allocable to a

    particular patient

    for a particular

    service.

    ER040..... laser, diode, for NF ................. 14 12 Refined equipment (0.12)

    patient time to conform to

    positioning established

    (Probe). policies for highly

    technical equipment.

    ER056..... radiation NF ................. 14 12 Refined equipment (3.15)

    treatment vault. time to conform to

    established

    policies for highly

    technical equipment.

    ER065..... water chiller NF ................. 14 12 Refined equipment (0.13)

    (radiation time to conform to

    treatment). established

    policies for highly

    technical equipment.

    ER089..... IMRT accelerator. NF ................. 14 12 Refined equipment (16.14)

    time to conform to

    established

    policies for highly

    technical equipment.

    ER102..... Power conditioner NF ................. 14 12 Refined equipment (0.17)

    time to conform to

    established

    policies for highly

    technical equipment.

    77407...... Radiation EQ139..... intercom (incl. NF ................. 17 0 Indirect Practice (0.06)

    treatment master, pt Expense; not

    delivery. substation, individually

    power, wiring). allocable to a

    particular patient

    for a particular

    service.

    ER040..... laser, diode, for NF ................. 19 17 Refined equipment (0.12)

    patient time to conform to

    positioning established

    (Probe). policies for highly

    technical equipment.

    ER056..... radiation NF ................. 19 17 Refined equipment (3.15)

    treatment vault. time to conform to

    established

    policies for highly

    technical equipment.

    ER065..... water chiller NF ................. 19 17 Refined equipment (0.13)

    (radiation time to conform to

    treatment). established

    policies for highly

    technical equipment.

    ER089..... IMRT accelerator. NF ................. 19 17 Refined equipment (16.14)

    time to conform to

    established

    policies for highly

    technical equipment.

    ER102..... Power conditioner NF ................. 19 17 Refined equipment (0.17)

    time to conform to

    established

    policies for highly

    technical equipment.

    77412...... Radiation EQ139..... intercom (incl. NF ................. 21 0 Indirect Practice (0.08)

    treatment master, pt Expense; not

    delivery. substation, individually

    power, wiring). allocable to a

    particular patient

    for a particular

    service.

    ER040..... laser, diode, for NF ................. 23 21 Refined equipment (0.12)

    patient time to conform to

    positioning established

    (Probe). policies for highly

    technical equipment.

    ER056..... radiation NF ................. 23 21 Refined equipment (3.15)

    treatment vault. time to conform to

    established

    policies for highly

    technical equipment.

    ER065..... water chiller NF ................. 23 21 Refined equipment (0.13)

    (radiation time to conform to

    treatment). established

    policies for highly

    technical equipment.

    Page 41752

    ER089..... IMRT accelerator. NF ................. 23 21 Refined equipment (16.14)

    time to conform to

    established

    policies for highly

    technical equipment.

    ER102..... Power conditioner NF ................. 23 21 Refined equipment (0.17)

    time to conform to

    established

    policies for highly

    technical equipment.

    88104...... Cytopath fl nongyn EP024..... microscope, NF ................. 60 56 Refined to conform (0.15)

    smears. compound. with identical

    labor activity in

    other codes in the

    family.

    L033A..... Lab Technician... NF Order, restock, 0.5 0 Indirect Practice (0.17)

    and distribute Expense; not

    specimen individually

    containers with allocable to a

    requisition particular patient

    forms.. for a particular

    service.

    88106...... Cytopath fl nongyn L033A..... Lab Technician... NF Order, restock, 0.5 0 Indirect Practice (0.17)

    filter. and distribute Expense; not

    specimen individually

    containers with allocable to a

    requisition particular patient

    forms.. for a particular

    service.

    88108...... Cytopath L033A..... Lab Technician... NF Order, restock, 0.5 0 Indirect Practice (0.17)

    concentrate tech. and distribute Expense; not

    specimen individually

    containers with allocable to a

    requisition particular patient

    forms.. for a particular

    service.

    88160...... Cytopath smear EP038..... solvent recycling NF ................. 1 0 Refined equipment (0.05)

    other source. system. time to conform to

    clinical labor time.

    L035A..... Lab Tech/ NF Prepare automated 6 4 Refined time to (0.70)

    Histotechnologis stainer with standard time for

    t. solutions and this clinical labor

    load microscopic task.

    slides. Set and

    confirm stainer

    program. Set and

    confirm stainer

    program.

    L035A..... Lab Tech/ NF Stain air dried 5 0 See preamble text... (1.75)

    Histotechnologis slides with

    t. modified Wright

    stain. Review

    slides for

    malignancy/high

    cellularity

    (cross

    contamination).

    88161...... Cytopath smear EP038..... solvent recycling NF ................. 1 0 Refined equipment (0.05)

    other source. system. time to conform to

    clinical labor time.

    Cytopath smear L035A..... Lab Tech/ NF Prepare automated 6 4 Refined time to (0.70)

    other source. Histotechnologis stainer with standard time for

    t. solutions and this clinical labor

    load microscopic task.

    slides. Set and

    confirm stainer

    program. Set and

    confirm stainer

    program.

    Cytopath smear L035A..... Lab Tech/ NF Stain air dried 5 3 Refined time to (0.70)

    other source. Histotechnologis slides with standard time for

    t. modified Wright this clinical labor

    stain. Review task.

    slides for

    malignancy/high

    cellularity

    (cross

    contamination).

    88162...... Cytopath smear EP038..... solvent recycling NF ................. 1 0 Refined equipment (0.05)

    other source. system. time to conform to

    clinical labor time.

    Page 41753

    Cytopath smear L035A..... Lab Tech/ NF Other Clinical 6 4 Refined time to (0.70)

    other source. Histotechnologis Activity (please standard time for

    t. specify): this clinical labor

    Prepare task.

    automated

    stainer with

    solutions and

    load microscopic

    slides.

    88182...... Cell marker study. L033A..... Lab Technician... NF Accession 6 4 Refined time to (0.66)

    specimen/prepare standard time for

    for examination. this clinical labor

    task.

    Cell marker study. L033A..... Lab Technician... NF Clean room/ 2 1 Refined time to (0.33)

    equipment standard time for

    following this clinical labor

    procedure task.

    (including any

    equipment

    maintenance that

    must be done

    after the

    procedure).

    L033A..... Lab Technician... NF Dispose of 2 1 Refined time to (0.33)

    remaining standard time for

    specimens, spent this clinical labor

    chemicals/other task.

    consumables, and

    hazardous waste.

    L033A..... Lab Technician... NF Prepare, pack and 2 1 Refined time to (0.33)

    transport standard time for

    specimens and this clinical labor

    records for in- task.

    house storage

    and external

    storage (where

    applicable).

    L045A..... Cytotechnologist. NF Clean room/ 2 1 Refined time to (0.45)

    equipment standard time for

    following this clinical labor

    procedure task.

    (including any

    equipment

    maintenance that

    must be done

    after the

    procedure).

    L045A..... Cytotechnologist. NF Enter data into 2 0 Refined time to (0.90)

    laboratory standard time for

    information this clinical labor

    system, task.

    multiparameter

    analyses and

    field data en.

    L045A..... Cytotechnologist. NF Print out 5 2 Refined time to (1.35)

    histograms, standard time for

    assemble this clinical labor

    materials with task.

    paperwork to

    pathologists

    Review

    histograms and

    gating with

    pathologist.

    88184...... Flowcytometry/tc 1 ED031..... printer, dye NF ................. 5 1 Refined equipment (0.04)

    marker. sublimation time to conform to

    (photo, color). clinical labor time.

    L033A..... Lab Technician... NF Clean room/ 2 1 Refined time to (0.33)

    equipment standard time for

    following this clinical labor

    procedure task.

    (including any

    equipment

    maintenance that

    must be done

    after the

    procedure).

    Page 41754

    L033A..... Lab Technician... NF Enter data into 4 0 Refined time to (1.32)

    laboratory standard time for

    information this clinical labor

    system, task.

    multiparameter

    analyses and

    field data en.

    L045A..... Cytotechnologist. NF Instrument start- 15 13 Refined to conform (0.90)

    up, quality with identical

    control labor activity in

    functions, other codes in the

    calibration, family.

    centrifugation,

    maintaining

    specimen

    tracking, logs

    and labeling.

    L045A..... Cytotechnologist. NF Other Clinical 10 7 Refined to conform (1.35)

    Activity (please with identical

    specify) Load labor activity in

    specimen into other codes in the

    flow cytometer, family.

    run specimen,

    monitor data

    acquisition, and.

    L045A..... Cytotechnologist. NF Print out 5 2 Refined time to (1.35)

    histograms, standard time for

    assemble this clinical labor

    materials with task.

    paperwork to

    pathologists

    Review

    histograms and

    gating with

    pathologist.

    88185...... Flowcytometry/tc ED031..... printer, dye NF ................. 2 1 Refined equipment (0.01)

    add-on. sublimation time to conform to

    (photo, color). clinical labor time.

    L033A..... Lab Technician... NF Enter data into 1 0 Refined time to (0.33)

    laboratory standard time for

    information this clinical labor

    system, task.

    multiparameter

    analyses and

    field data en.

    88321...... Microslide L033A..... Lab Technician... NF Accession 4 0 Duplication with (1.32)

    consultation. specimen/prepare other clinical

    for examination. labor task.

    L033A..... Lab Technician... NF Register the 13 5 See preamble text... (2.64)

    patient in the

    information

    system,

    including all

    demographic and

    billing

    information. In

    addition to

    stand.

    L037B..... Histotechnologist NF Phone calls for 0 3 Input added to 1.11

    clarifications maintain

    and/or consistency with

    additional all other codes

    materials. within family.

    88323...... Microslide L033A..... Lab Technician... NF Register the 13 5 Non-standard (2.64)

    consultation. patient in the refinement, see

    information preamble text.

    system,

    including all

    demographic and

    billing

    information. In

    addition to

    stand.

    L037B..... Histotechnologist NF Assemble and 1 0 Duplication with (0.37)

    deliver slides other clinical

    with paperwork labor task.

    to pathologists.

    L037B..... Histotechnologist NF Clean equipment 1 0 Duplication with (0.37)

    while performing other clinical

    service. labor task.

    SL063..... eosin y.......... NF ................. 8 0 Redundant when used (6.41)

    together with SL135.

    Page 41755

    SL135..... stain, NF ................. 32 8 Refined supply (1.06)

    hematoxylin. quantity to what is

    typical for the

    procedure.

    88325...... .................. EP019..... hood, ventilator NF ................. 1 0 See preamble text... --

    with blower.

    EP033..... slide NF ................. 6 0 See preamble text... (0.57)

    coverslipper,

    robotic.

    EP034..... slide dryer...... NF ................. 1 0 See preamble text... --

    EP035..... slide etcher- NF ................. 1 0 See preamble text... (0.05)

    labeler.

    EP036..... slide stainer, NF ................. 12 0 See preamble text... (0.55)

    automated, high-

    volume

    throughput.

    EP038..... solvent recycling NF ................. 4 0 See preamble text... (0.18)

    system.

    EP043..... water bath, NF ................. 6 0 See preamble text... (0.01)

    general purpose

    (lab).

    ER041..... microtome........ NF ................. 6 0 See preamble text... (0.26)

    L033A..... Lab Technician... NF Prepare room. 10 0 Indirect Practice (3.30)

    Filter and Expense; not

    replenish stains individually

    and supplies. allocable to a

    (including OCT particular patient

    blocks, set up for a particular

    grossing station service.

    with colored

    stain.

    L033A..... Lab Technician... NF Accession 4 0 Duplication with (1.32)

    specimen/prepare other clinical

    for examination. labor task.

    L033A..... Lab Technician... NF Dispose of 1 0 See preamble text... (0.33)

    remaining

    specimens, spent

    chemicals/other

    consumables, and

    hazardous waste.

    L033A..... Lab Technician... NF Register the 13 5 See preamble text... (2.64)

    patient in the

    information

    system,

    including all

    demographic and

    billing

    information. In

    addition to

    stand.

    L033A..... Lab Technician... NF prepare, pack and 2 0 See preamble text... (0.66)

    transport

    specimens and

    records for in-

    house storage

    and external

    storage.

    L037B..... Histotechnologist NF Clean equipment 1 0 Duplication with (0.37)

    while performing other clinical

    service. labor task.

    L037B..... Histotechnologist NF Complete workload 1 0 See preamble text... (0.37)

    recording logs.

    Collate slides

    and paperwork.

    Deliver to

    pathologist.

    L037B..... Histotechnologist NF Prepare automated 1 0 See preamble text... (0.37)

    coverslipper,

    remove slides

    from stainer and

    place on

    coverslipper.

    Page 41756

    L037B..... Histotechnologist NF Prepare automated 1 0 See preamble text... (0.37)

    stainer with

    solutions and

    load microscopic

    slides. Set and

    confirm stainer

    program. Set and

    confirm stainer

    program.

    L037B..... Histotechnologist NF Slide preparation 4 0 See preamble text... (1.48)

    sectioning and

    recuts, quality

    control

    function,

    maintaining

    specimen

    tracking, logs

    and labeling.

    SB023..... gloves, non- NF ................. 2 0 See preamble text... (0.38)

    sterile, nitrile.

    SB027..... gown, staff, NF ................. 0.1 0 See preamble text... (0.12)

    impervious.

    SF004..... blade, microtome. NF ................. 0.2 0 See preamble text... (0.34)

    SL020..... bleach........... NF ................. 10 0 See preamble text... (0.01)

    SL030..... cover slip, glass NF ................. 2 0 See preamble text... (0.16)

    SL063..... eosin y.......... NF ................. 8 0 See preamble text... (6.41)

    SL078..... histology NF ................. 0.2 0 See preamble text... (0.29)

    freezing spray

    (Freeze-It).

    SL085..... label for NF ................. 20 10 See preamble text... (0.26)

    microscope

    slides.

    SL095..... mounting media NF ................. 2 0 See preamble text... (0.07)

    (Histomount).

    SL122..... slide, microscope NF ................. 2 0 See preamble text... (0.11)

    SL135..... stain, NF ................. 32 0 See preamble text... (1.41)

    hematoxylin.

    SL151..... xylenes solvent.. NF ................. 60 0 See preamble text... (0.72)

    SL189..... ethanol, 100%.... NF ................. 60 0 See preamble text... (0.20)

    SL190..... ethanol, 70%..... NF ................. 8 0 See preamble text... (0.03)

    SL248..... ethanol, 95%..... NF ................. 36 0 See preamble text... (0.12)

    SM027..... wipes, lens NF ................. 2 0 See preamble text... (0.03)

    cleaning (per

    wipe) (Kimwipe).

    88329...... Path consult L037B..... Histotechnologist NF Assist 10 3 Refined time to (2.59)

    introp. pathologist with standard time for

    gross specimen this clinical labor

    examination. task.

    L037B..... Histotechnologist NF Clean room/ 5 1 Refined time to (1.48)

    equipment standard time for

    following this clinical labor

    procedure task.

    (including any

    equipment

    maintenance that

    must be done

    after the

    procedure).

    88331...... Path consult L033A..... Lab Technician... NF Prepare room. 10 0 Indirect Practice 1.48

    intraop 1 bloc. Filter and Expense; not

    replenish stains individually

    and supplies. allocable to a

    (including OCT particular patient

    blocks, set up for a particular

    grossing station service.

    with colored

    stai.

    L037B..... Histotechnologist NF Accession 0 4 Input added to 1.48

    specimen/prepare maintain

    for examination. consistency with

    all other codes

    within family.

    L037B..... Histotechnologist NF Assemble and 2 0.5 Refined time to (0.56)

    deliver slides standard time for

    with paperwork this clinical labor

    to pathologists. task.

    L037B..... Histotechnologist NF Assist 10 3 Refined time to (2.59)

    pathologist with standard time for

    gross specimen this clinical labor

    examination. task.

    Page 41757

    L037B..... Histotechnologist NF Clean room/ 10 1 Refined time to (3.33)

    equipment standard time for

    following this clinical labor

    procedure task.

    (including any

    equipment

    maintenance that

    must be done

    after the

    procedure).

    SL134..... stain, frozen NF ................. 0 1 Supply item replaces 0.57

    section, H&E another item

    (1ml per slide). (SL231); see

    preamble.

    SL231..... kit, stain, H&E.. NF ................. 0.1 0 Supply item replaced (9.80)

    by another item

    (SL134); see

    preamble.

    88332...... Path consult L037B..... Histotechnologist NF Assemble and 2 0.5 Refined time to (0.56)

    intraop addl. deliver slides standard time for

    with paperwork this clinical labor

    to pathologists. task.

    L037B..... Histotechnologist NF Assist 2 3 Refined time to 0.37

    pathologist with standard time for

    gross specimen this clinical labor

    examination. task.

    L037B..... Histotechnologist NF Clean room/ 0 1 Input added to 0.37

    equipment maintain

    following consistency with

    procedure all other codes

    (including any within family.

    equipment

    maintenance that

    must be done

    after the

    procedure).

    SF047..... scalpel, safety, NF ................. 0 1 Input added to 2.14

    surgical, with maintain

    blade (#10-20). consistency with

    all other codes

    within family.

    SL134..... stain, frozen NF ................. 0 1 Supply item replaces 0.57

    section, H&E another item

    (1ml per slide). (SL231); see

    preamble.

    SL231..... kit, stain, H&E.. NF ................. 0.1 0 Supply item replaced (9.80)

    by another item

    (SL134); see

    preamble.

    88333...... Intraop cyto path L033A..... Lab Technician... NF Prepare room. 10 0 Indirect Practice (3.30)

    consult 1. Filter and Expense; not

    replenish stains individually

    and supplies. allocable to a

    (including OCT particular patient

    blocks, set up for a particular

    grossing station service.

    with colored

    stai.

    L037B..... Histotechnologist NF Accession 0 4 Input added to 1.48

    specimen/prepare maintain

    for examination. consistency with

    all other codes

    within family.

    L037B..... Histotechnologist NF Assemble and 2 0.5 Refined time to (1.48)

    deliver slides standard time for

    with paperwork this clinical labor

    to pathologists. task.

    L037B..... Histotechnologist NF Assist 7 3 Refined time to (1.48)

    pathologist with standard time for

    gross specimen this clinical labor

    examination task.

    (including

    performance of

    intraoperative

    frozen sections).

    L037B..... Histotechnologist NF Clean room/ 5 1 Refined time to (1.48)

    equipment standard time for

    following this clinical labor

    procedure task.

    (including any

    equipment

    maintenance that

    must be done

    after the

    procedure).

    Page 41758

    SL122..... slide, microscope NF ................. 10 4 Refined supply (0.33)

    quantity to what is

    typical for the

    procedure.

    SL231..... kit, stain, H&E.. NF ................. 0.1 0 Removed supply not (9.80)

    typically used in

    this service.

    88334...... Intraop cyto path L037B..... Histotechnologist NF Assemble and 2 0.5 Refined time to (0.56)

    consult 2. deliver slides standard time for

    with paperwork this clinical labor

    to pathologists. task.

    L037B..... Histotechnologist NF Assist 5 3 Refined time to (0.74)

    pathologist with standard time for

    gross specimen this clinical labor

    examination task.

    (including

    performance of

    intraoperative

    frozen sections).

    L037B..... Histotechnologist NF Clean room/ 0 1 Input added to 0.37

    equipment maintain

    following consistency with

    procedure all other codes

    (including any within family.

    equipment

    maintenance that

    must be done

    after the

    procedure).

    SL122..... slide, microscope NF ................. 10 4 Refined supply (0.33)

    quantity to what is

    typical for the

    procedure.

    SL231..... kit, stain, H&E.. NF ................. 0.1 0 Removed supply not (9.80)

    typically used in

    this service.

    88355...... Analysis skeletal EP046..... freezer, NF ................. 30 0 Indirect Practice (1.32)

    muscle. ultradeep (-70 Expense; not

    degrees). individually

    allocable to a

    particular patient

    for a particular

    service.

    L033A..... Lab Technician... NF Accession 6 4 Refined time to (0.66)

    specimen/prepare standard time for

    for examination. this clinical labor

    task.

    L033A..... Lab Technician... NF Assemble and 2 0.5 Refined time to (0.50)

    deliver slides standard time for

    with paperwork this clinical labor

    to pathologists. task.

    L033A..... Lab Technician... NF Clean room, 2 1 Refined time to (0.33)

    equipment standard time for

    following this clinical labor

    procedure task.

    including any

    equipment

    maintenance that

    must be done

    after the

    procedure.

    L033A..... Lab Technician... NF Dispose of 2 1 Refined time to (0.33)

    remaining standard time for

    specimens, spent this clinical labor

    chemicals/other task.

    consumables, and

    hazardous waste.

    L033A..... Lab Technician... NF Prepare specimen 9 0.5 Refined time to (2.81)

    containers/ standard time for

    preload fixative/ this clinical labor

    label containers/ task.

    distribute

    requisition

    form(s) to

    physician.

    L033A..... Lab Technician... NF Prepare specimen 5 0 Refined time to (1.65)

    for -70 degree standard time for

    storage, log this clinical labor

    specimen and task.

    place in freezer

    for retrieval

    and performance

    of quantitative.

    Page 41759

    L033A..... Lab Technician... NF Prepare, pack and 4 1 Refined time to (0.99)

    transport standard time for

    specimens and this clinical labor

    records for task.

    storage.

    L033A..... Lab Technician... NF Receive phone 7 5 See preamble text... (0.66)

    call from

    referring

    laboratory/

    facility with

    scheduled

    procedure to

    arrange special

    delivery of

    specimen p.

    L037B..... Histotechnologist NF Assist 7 3 Refined time to (1.48)

    pathologist with standard time for

    gross this clinical labor

    examination. task.

    88360...... Tumor EP024..... microscope, NF ................. 36 25 See preamble text... (0.41)

    immunohistochem/ compound.

    manual.

    L033A..... Lab Technician... NF Recycle xylene 1 0 Non-standard (0.33)

    from tissue clinical labor task.

    processor and

    stainer.

    L037B..... Histotechnologist NF Enter patient 5 1 Refined time to (1.48)

    data, standard time for

    computational this clinical labor

    prep for task.

    antibody

    testing,

    generate and

    apply bar codes

    to slides, and

    enter data for.

    L037B..... Histotechnologist NF Verify results 1 0 Refined time to (0.37)

    and complete standard time for

    work load this clinical labor

    recording logs. task.

    88361...... Tumor L033A..... Lab Technician... NF Recycle xylene 1 0 Non-standard (0.33)

    immunohistochem/ from tissue clinical labor task.

    comput. processor and

    stainer.

    L037B..... Histotechnologist NF Enter patient 5 1 Refined time to (1.48)

    data, standard time for

    computational this clinical labor

    prep for task.

    antibody

    testing,

    generate and

    apply bar codes

    to slides, and

    enter data for.

    L037B..... Histotechnologist NF Verify results 1 0 Refined time to (0.37)

    and complete standard time for

    work load this clinical labor

    recording logs. task.

    88362...... Nerve teasing L033A..... Lab Technician... NF Assemble and 2 0.5 Refined time to (0.50)

    preparations. deliver cedar standard time for

    mounted slides this clinical labor

    with paperwork task.

    to pathologists.

    L033A..... Lab Technician... NF Assemble other 5 0.5 Refined time to (1.49)

    light microscopy standard time for

    slides, epon this clinical labor

    nerve biopsy task.

    slides, and

    clinical

    history, and

    present to

    pathologist to

    pr.

    Page 41760

    L033A..... Lab Technician... NF Clean room/ 7 1 Refined time to (1.98)

    equipment standard time for

    following this clinical labor

    procedure task.

    (including

    dissecting

    microscope and

    dissection work

    area. Cedar oil

    specific c.

    L033A..... Electrodiagnostic NF Preparation: 2 0.5 Refined time to (0.50)

    Technologist. labeling of standard time for

    blocks and this clinical labor

    containers and task.

    document

    location and

    processor used.

    L037B..... Histotechnologist NF Accession 10 4 Refined time to (2.22)

    specimen and standard time for

    prepare for this clinical labor

    examination. task.

    L037B..... Histotechnologist NF Assist 10 5 Non-standard (1.85)

    pathologist with refinement, see

    gross specimen preamble text.

    examination

    including the

    following; A ;

    Selection of

    fresh unfixed

    tissue samp.

    L037B..... Histotechnologist NF Consult with 7 0 Task would not be (2.59)

    pathologist required for the

    regarding typical procedure.

    representation

    needed, block

    selection and

    appropriate

    technique.

    L037B..... Histotechnologist NF Dispose of 2 1 Refined time to (0.37)

    remaining standard time for

    specimens, spent this clinical labor

    chemicals/other task.

    consumables, and

    hazardous waste.

    L037B..... Histotechnologist NF Manage any 2 0 Refined time to (0.74)

    relevant standard time for

    utilization this clinical labor

    review/quality task.

    assurance

    activities and

    regulatory

    compliance

    documentation.

    L037B..... Histotechnologist NF Prepare specimen 12 0.5 Refined time to (4.26)

    containers standard time for

    preload fixative this clinical labor

    label containers task.

    distribute

    requisition

    form(s) to

    physician.

    L037B..... Histotechnologist NF Prepare, pack and 10 0 Refined time to (3.70)

    transport cedar standard time for

    oiled glass this clinical labor

    slides and task.

    records for in-

    house special

    storage (need to

    be stored flat).

    L037B..... Histotechnologist NF Prepare, pack and 2 1 Refined time to (0.37)

    transport standard time for

    specimens and this clinical labor

    records for in- task.

    house storage

    and external

    storage (where

    applicable).

    Page 41761

    L037B..... Histotechnologist NF Storage remaining 5 0 Refined time to (1.85)

    specimen. standard time for

    (Osmicated nerve this clinical labor

    strands, task.

    potential for

    additional

    teased

    specimens).

    92511...... Nasopharyngoscopy. EF008..... chair with NF ................. 19 26 Refined equipment 0.08

    headrest, exam, time to conform to

    reclining. established

    policies for non-

    highly technical

    equipment.

    EQ167..... light source, NF ................. 19 0 Redundant when used (0.51)

    xenon. together with

    EQ170; see preamble.

    EQ170..... light, fiberoptic NF ................. 19 26 Refined equipment 0.06

    headlight w- time to conform to

    source. established

    policies for non-

    highly technical

    equipment.

    ES020..... fiberscope, NF ................. 46 53 Refined equipment 0.26

    flexible, time to conform to

    rhinolaryngoscop established

    y. policies for scopes.

    ES031..... video system, NF ................. 19 26 Refined equipment 0.90

    endoscopy time to conform to

    (processor, established

    digital capture, policies for non-

    monitor, highly technical

    printer, cart). equipment.

    L037D..... RN/LPN/MTA....... F Dischrge Day 6 0 Aligned clinical (2.22)

    mgmt. (0.5 x labor discharge day

    99238) (enter 6 management time

    min). with the work time

    discharge day code.

    SB006..... drape, non- NF ................. 1 0 Removed supply not (0.22)

    sterile, sheet typically used in

    40in x 60in. this service.

    SB027..... gown, staff, NF ................. 2 0 Removed supply not (2.37)

    impervious. typically used in

    this service.

    SB033..... mask, surgical... NF ................. 2 0 Removed supply not (0.39)

    typically used in

    this service.

    SD070..... endosheath....... NF ................. 1 0 Removed supply not (17.25)

    typically used in

    this service.

    95812...... Eeg 41-60 minutes. EF003..... bedroom furniture NF ................. 124 99 Refined equipment (0.15)

    (hospital bed, time to conform to

    table, reclining established

    chair). policies for non-

    highly technical

    equipment.

    EQ017..... EEG, digital, NF ................. 133 99 Refined equipment (4.99)

    prolonged time to conform to

    testing system established

    (computer w- policies for non-

    remote camera). highly technical

    equipment.

    L047B..... REEGT............ NF Assist physician 79 50 Refined clinical (13.63)

    in performing labor time to match

    procedure. physician

    intraservice time.

    L047B..... REEGT............ NF Enter patient 2 0 Refined to conform (0.94)

    information into with identical

    laboratory log labor activity in

    book. other codes in the

    family.

    L047B..... REEGT............ NF Provide pre- 2 0 Duplication with (0.94)

    service other clinical

    education/obtain labor task.

    consent.

    L047B..... REEGT............ NF Transfer data to 4 2 Refined time to (0.94)

    reading station standard time for

    & archive data. this clinical labor

    task.

    95813...... Eeg over 1 hour... EF003..... bedroom furniture NF ................. 147 129 Refined equipment (0.11)

    (hospital bed, time to conform to

    table, reclining established

    chair). policies for non-

    highly technical

    equipment.

    EQ017..... EEG, digital, NF ................. 156 129 Refined equipment (3.96)

    prolonged time to conform to

    testing system established

    (computer w- policies for non-

    remote camera). highly technical

    equipment.

    L047B..... REEGT............ NF Assist physician 102 80 Refined clinical (10.34)

    in performing labor time to match

    procedure. physician

    intraservice time.

    Page 41762

    L047B..... REEGT............ NF Enter patient 2 0 Refined to conform (0.94)

    information into with identical

    laboratory log labor activity in

    book. other codes in the

    family.

    L047B..... REEGT............ NF Provide pre- 2 0 Duplication with (0.94)

    service other clinical

    education/obtain labor task.

    consent.

    L047B..... REEGT............ NF Transfer data to 4 2 Refined time to (0.94)

    reading station standard time for

    & archive data. this clinical labor

    task.

    95863...... Muscle test 3 EF023..... table, exam...... NF ................. 52 55 Refined equipment 0.01

    limbs. time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EQ024..... EMG-NCV-EP NF ................. 52 55 Refined equipment 0.44

    system, 8 time to conform to

    channel. established

    policies for non-

    highly technical

    equipment.

    L037A..... Electrodiagnostic NF Clean room/ 0 3 Refined to conform 1.11

    Technologist. equipment by with identical

    physician staff. labor activity in

    other codes in the

    family.

    95864...... Muscle test 4 EF023..... table, exam...... NF ................. 62 65 Refined equipment 0.01

    limbs. time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EQ024..... EMG-NCV-EP NF ................. 62 65 Refined equipment 0.44

    system, 8 time to conform to

    channel. established

    policies for non-

    highly technical

    equipment.

    L037A..... Electrodiagnostic NF Other Clinical 6 0 Refined to conform (2.22)

    Technologist. Activity--specif with identical

    y:Prepare labor activity in

    technician other codes in the

    report, family.

    summarize

    clinical and

    electrodiagnosti

    c data, and

    interpre.

    95869...... Muscle test thor EF023..... table, exam...... NF ................. 27 30 Refined equipment 0.01

    paraspinal. time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EQ024..... EMG-NCV-EP NF ................. 27 30 Refined equipment 0.44

    system, 8 time to conform to

    channel. established

    policies for non-

    highly technical

    equipment.

    L037A..... Electrodiagnostic NF Clean room/ 0 3 Refined to conform 1.11

    Technologist. equipment by with identical

    physician staff. labor activity in

    other codes in the

    family.

    95870...... Muscle test EF023..... table, exam...... NF ................. 27 30 Refined equipment 0.01

    nonparaspinal. time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EQ024..... EMG-NCV-EP NF ................. 27 30 Refined equipment 0.44

    system, 8 time to conform to

    channel. established

    policies for non-

    highly technical

    equipment.

    L037A..... Electrodiagnostic NF Clean room/ 0 3 Refined to conform 1.11

    Technologist. equipment by with identical

    physician staff. labor activity in

    other codes in the

    family.

    SD275..... Disposable NF ................. 6 1 Refined supply (13.75)

    electrode pack. quantity to what is

    typical for the

    procedure.

    95923...... Autonomic nrv syst EF023..... table, exam...... NF ................. 51 43 Refined equipment (0.02)

    funj test. time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EQ035..... QSART acquisition NF ................. 46 43 Refined equipment (0.33)

    system (Q-Sweat). time to conform to

    established

    policies for non-

    highly technical

    equipment.

    Page 41763

    EQ124..... stimulator, NF ................. 46 43 Refined equipment (0.01)

    constant time to conform to

    current, w- established

    stimulating and policies for non-

    grounding highly technical

    electrodes equipment.

    (Grass

    Telefactor).

    EQ171..... light, infra-red, NF ................. 46 43 Refined equipment ........

    ceiling mount. time to conform to

    established

    policies for non-

    highly technical

    equipment.

    L037A..... Electrodiagnostic NF Clean room/ 5 0 Typically billed (1.85)

    Technologist. equipment by with an E/M or

    physician staff. other evaluation

    service.

    L037A..... Electrodiagnostic NF Complete 5 0 Typically billed (1.85)

    Technologist. diagnostic with an E/M or

    forms, lab & X- other evaluation

    ray requisitions. service.

    L037A..... Electrodiagnostic NF Complete pre- 5 2 Refined to conform (1.11)

    Technologist. service with identical

    diagnostic & labor activity in

    referral forms. other codes in the

    family.

    L037A..... Electrodiagnostic NF Prepare room, 0 2 Refined time to 0.74

    Technologist. equipment, standard time for

    supplies. this clinical labor

    task.

    SA014..... kit, electrode, NF ................. 4 3 See preamble text... (4.01)

    iontophoresis.

    SA048..... pack, minimum NF ................. 1 0 Typically billed (1.14)

    multi-specialty with an E/M or

    visit. other evaluation

    service.

    95928...... C motor evoked EF023..... table, exam...... NF ................. 65 45 Refined equipment (0.06)

    uppr limbs. time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EQ024..... EMG-NCV-EP NF ................. 65 45 Refined equipment (2.95)

    system, 8 time to conform to

    channel. established

    policies for non-

    highly technical

    equipment.

    EQ178..... magnetic NF ................. 65 45 Refined equipment (0.16)

    stimulator hand time to conform to

    coil (70-90mm). established

    policies for non-

    highly technical

    equipment.

    EQ180..... magnetic NF ................. 65 45 Refined equipment (1.43)

    stimulator time to conform to

    system (BiStim). established

    policies for non-

    highly technical

    equipment.

    L047B..... REEGT............ NF Assist physician 60 40 Refined clinical (9.40)

    in performing labor time to match

    procedure. physician

    intraservice time.

    L047B..... REEGT............ NF Other Clinical 3 0 Duplication with (1.41)

    Activity--specif other clinical

    y: Review labor task.

    requisition.

    Assess for

    special needs.

    Give patient

    instructions for

    test prepa.

    SA048..... pack, minimum NF ................. 1 0 Typically billed (1.14)

    multi-specialty with an E/M or

    visit. other evaluation

    service.

    95929...... C motor evoked lwr EF023..... table, exam...... NF ................. 65 45 Refined equipment (0.06)

    limbs. time to conform to

    established

    policies for non-

    highly technical

    equipment.

    EQ024..... EMG-NCV-EP NF ................. 65 45 Refined equipment (2.95)

    system, 8 time to conform to

    channel. established

    policies for non-

    highly technical

    equipment.

    EQ179..... magnetic NF ................. 65 45 Refined equipment (0.24)

    stimulator leg time to conform to

    coil (110mm). established

    policies for non-

    highly technical

    equipment.

    EQ180..... magnetic NF ................. 65 45 Refined equipment (1.43)

    stimulator time to conform to

    system (BiStim). established

    policies for non-

    highly technical

    equipment.

    Page 41764

    L047B..... REEGT............ NF Assist physician 60 40 Refined clinical (9.40)

    in performing labor time to match

    procedure. physician

    intraservice time.

    L047B..... REEGT............ NF Other Clinical 3 0 Duplication with (1.41)

    Activity--specif other clinical

    y:Review labor task.

    requisition.

    Assess for

    special needs.

    Give patient

    instructions for

    test prepa.

    95933...... Blink reflex test. L037A..... Electrodiagnostic NF Clean room/ 5 3 Refined time to (0.74)

    Technologist. equipment by standard time for

    physician staff. this clinical labor

    task.

    L037A..... Electrodiagnostic NF Prepare room, 0 2 Refined time to 0.74

    Technologist. equipment, standard time for

    supplies. this clinical labor

    task.

    95956...... Eeg monitor EF003..... bedroom furniture NF ................. 772 769 Refined equipment (0.02)

    technol attended. (hospital bed, time to conform to

    table, reclining established

    chair). policies for non-

    highly technical

    equipment.

    EQ017..... EEG, digital, NF ................. 772 769 Refined equipment (0.44)

    prolonged time to conform to

    testing system established

    (computer w- policies for non-

    remote camera). highly technical

    equipment.

    EQ047..... air compressor, NF ................. 52 49 Refined equipment ........

    safety. time to conform to

    established

    policies for non-

    highly technical

    equipment.

    L047B..... REEGT............ NF Other Clinical 3 0 Duplication with (1.41)

    Activity--specif other clinical

    y: Coordinate labor task.

    pretesting

    services/review

    test/exam

    results.

    L047B..... REEGT............ NF Provide pre- 2 0 Duplication with (0.94)

    service other clinical

    education/obtain labor task.

    consent.

    --------------------------------------------------------------------------------------------------------------------------------------------------------

    Table 14--Crosswalk for Establishing CY 2016 New, Revised, and Potentially Misvalued Codes Malpractice RVUs

    ----------------------------------------------------------------------------------------------------------------

    ----------------------------------------------------------------------------------------------------------------

    CY 2016 New, Revised or Potentially MMalpractice Risk Factor Crosswalk Code

    ----------------------------------------------------------------------------------------------------------------

    11750........................ Removal of nail bed..... 11750........................ Removal of nail bed.

    20240........................ Bone biopsy excisional.. 20240........................ Bone biopsy excisional.

    27280........................ Fusion of sacroiliac 27280........................ Fusion of sacroiliac

    joint. joint.

    31622........................ Dx bronchoscope/wash.... 31622........................ Dx bronchoscope/wash.

    3160A........................ Bronch ebus sampling 1/2 31620........................ Endobronchial us add-on.

    node.

    3160B........................ Bronch ebus samplng 3/> 31620........................ Endobronchial us add-on.

    node.

    31625........................ Bronchoscopy w/biopsy(s) 31625........................ Bronchoscopy w/

    biopsy(s).

    31626........................ Bronchoscopy w/markers.. 31626........................ Bronchoscopy w/markers.

    31628........................ Bronchoscopy/lung bx 31628........................ Bronchoscopy/lung bx

    each. each.

    31629........................ Bronchoscopy/needle bx 31629........................ Bronchoscopy/needle bx

    each. each.

    3160C........................ Bronch ebus ivntj perph 31620........................ Endobronchial us add-on.

    les.

    31632........................ Bronchoscopy/lung bx 31632........................ Bronchoscopy/lung bx

    addl. addl.

    31633........................ Bronchoscopy/needle bx 31633........................ Bronchoscopy/needle bx

    addl. addl.

    3347A........................ Implant tcat pulm vlv 93581........................ Transcath closure of

    perq. vsd.

    3725A........................ Intrvasc us noncoronary 37250........................ Iv us first vessel add-

    1st. on.

    3725B........................ Intrvasc us noncoronary 37251........................ Iv us each add vessel

    addl. add-on.

    38570........................ Laparoscopy lymph node 38570........................ Laparoscopy lymph node

    biop. biop.

    38571........................ Laparoscopy 38571........................ Laparoscopy

    lymphadenectomy. lymphadenectomy.

    38572........................ Laparoscopy 38572........................ Laparoscopy

    lymphadenectomy. lymphadenectomy.

    3940A........................ Mediastinoscpy w/medstnl 33924........................ Remove pulmonary shunt.

    bx.

    3940B........................ Mediastinoscpy w/lmph 32606........................ Thoracoscopy w/bx med

    nod bx. space.

    44380........................ Small bowel endoscopy br/ 44380........................ Small bowel endoscopy br/

    wa. wa.

    44381........................ Small bowel endoscopy br/ 45340........................ Sig w/tndsc balloon

    wa. dilation.

    44382........................ Small bowel endoscopy... 44382........................ Small bowel endoscopy.

    Page 41765

    44384........................ Small bowel endoscopy... 44383........................ Ileoscopy w/stent.

    44385........................ Endoscopy of bowel pouch 44385........................ Endoscopy of bowel

    pouch.

    44386........................ Endoscopy bowel pouch/ 44386........................ Endoscopy bowel pouch/

    biop. biop.

    44388........................ Colonoscopy thru stoma 44388........................ Colonoscopy thru stoma

    spx. spx.

    44389........................ Colonoscopy with biopsy. 44389........................ Colonoscopy with biopsy.

    44390........................ Colonoscopy for foreign 44390........................ Colonoscopy for foreign

    body. body.

    44391........................ Colonoscopy for bleeding 44391........................ Colonoscopy for

    bleeding.

    44392........................ Colonoscopy & 44392........................ Colonoscopy &

    polypectomy. polypectomy.

    44394........................ Colonoscopy w/snare..... 44394........................ Colonoscopy w/snare.

    44401........................ Colonoscopy with 44393........................ Colonoscopy lesion

    ablation. removal.

    44402........................ Colonoscopy w/stent 44397........................ Colonoscopy w/stent.

    plcmt.

    44403........................ Colonoscopy w/resection. 44392........................ Colonoscopy &

    polypectomy.

    44404........................ Colonoscopy w/injection. 44389........................ Colonoscopy with biopsy.

    44405........................ Colonoscopy w/dilation.. 44390........................ Colonoscopy for foreign

    body.

    44406........................ Colonoscopy w/ultrasound 44394........................ Colonoscopy w/snare.

    45330........................ Diagnostic sigmoidoscopy 45330........................ Diagnostic

    sigmoidoscopy.

    45331........................ Sigmoidoscopy and biopsy 45331........................ Sigmoidoscopy and

    biopsy.

    45332........................ Sigmoidoscopy w/fb 45332........................ Sigmoidoscopy w/fb

    removal. removal.

    45333........................ Sigmoidoscopy & 45333........................ Sigmoidoscopy &

    polypectomy. polypectomy.

    45334........................ Sigmoidoscopy for 45334........................ Sigmoidoscopy for

    bleeding. bleeding.

    45335........................ Sigmoidoscopy w/submuc 45335........................ Sigmoidoscopy w/submuc

    inj. inj.

    45337........................ Sigmoidoscopy & 45337........................ Sigmoidoscopy &

    decompress. decompress.

    45338........................ Sigmoidoscopy w/tumr 45338........................ Sigmoidoscopy w/tumr

    remove. remove.

    45340........................ Sig w/tndsc balloon 45340........................ Sig w/tndsc balloon

    dilation. dilation.

    45341........................ Sigmoidoscopy w/ 45341........................ Sigmoidoscopy w/

    ultrasound. ultrasound.

    45342........................ Sigmoidoscopy w/us guide 45342........................ Sigmoidoscopy w/us guide

    bx. bx.

    45346........................ Sigmoidoscopy w/ablation 45339........................ Sigmoidoscopy w/ablate

    tumr.

    45347........................ Sigmoidoscopy w/plcmt 45345........................ Sigmoidoscopy w/stent.

    stent.

    45349........................ Sigmoidoscopy w/ 45338........................ Sigmoidoscopy w/tumr

    resection. remove.

    45350........................ Sgmdsc w/band ligation.. 45334........................ Sigmoidoscopy for

    bleeding.

    45378........................ Diagnostic colonoscopy.. 45378........................ Diagnostic colonoscopy.

    45379........................ Colonoscopy w/fb removal 45379........................ Colonoscopy w/fb

    removal.

    45380........................ Colonoscopy and biopsy.. 45380........................ Colonoscopy and biopsy.

    45381........................ Colonoscopy submucous 45381........................ Colonoscopy submucous

    njx. njx.

    45382........................ Colonoscopy w/control 45382........................ Colonoscopy w/control

    bleed. bleed.

    45384........................ Colonoscopy w/lesion 45384........................ Colonoscopy w/lesion

    removal. removal.

    45385........................ Colonoscopy w/lesion 45385........................ Colonoscopy w/lesion

    removal. removal.

    45386........................ Colonoscopy w/balloon 45386........................ Colonoscopy w/balloon

    dilat. dilat.

    45388........................ Colonoscopy w/ablation.. 45383........................ Lesion removal

    colonoscopy.

    45389........................ Colonoscopy w/stent 45387........................ Colonoscopy w/stent.

    plcmt.

    45390........................ Colonoscopy w/resection. 45385........................ Colonoscopy w/lesion

    removal.

    45391........................ Colonoscopy w/endoscope 45391........................ Colonoscopy w/endoscope

    us. us.

    45392........................ Colonoscopy w/endoscopic 45392........................ Colonoscopy w/endoscopic

    fnb. fnb.

    45393........................ Colonoscopy w/ 45382........................ Colonoscopy w/control

    decompression. bleed.

    45398........................ Colonoscopy w/band 45382........................ Colonoscopy w/control

    ligation. bleed.

    46500........................ Injection into 46500........................ Injection into

    hemorrhoid(s). hemorrhoid(s).

    47135........................ Transplantation of liver 47135........................ Transplantation of

    liver.

    5039A........................ Njx px nfrosgrm &/ 50390........................ Drainage of kidney

    urtrgrm. lesion.

    5039B........................ Njx px nfrosgrm &/ 50394........................ Injection for kidney x-

    urtrgrm. ray.

    5039C........................ Plmt nephrostomy 50392........................ Insert kidney drain.

    catheter.

    5039D........................ Plmt nephroureteral 50393........................ Insert ureteral tube.

    catheter.

    5039M........................ Convert nephrostomy 50393........................ Insert ureteral tube.

    catheter.

    5039E........................ Exchange nephrostomy 50398........................ Change kidney tube.

    cath.

    5069G........................ Plmt ureteral stent prq. 50398........................ Change kidney tube.

    5069H........................ Plmt ureteral stent prq. 50393........................ Insert ureteral tube.

    5069I........................ Plmt ureteral stent prq. 50393........................ Insert ureteral tube.

    5443A........................ Repair corporeal tear... 54406........................ Remove muti-comp penis

    pros.

    5443B........................ Replantation of penis... 53448........................ Remov/replc ur sphinctr

    comp.

    657XG........................ Impltj ntrstrml crnl rng 65426........................ Removal of eye lesion.

    seg.

    7208A........................ X-ray exam entire spi 1 72050........................ X-ray exam neck spine 4/

    vw. 5vws.

    7208B........................ X-ray exam entire spi 2/ 72052........................ X-ray exam neck spine 6/

    3 vw. >vws.

    7208C........................ X-ray exam entire spi 4/ 72052........................ X-ray exam neck spine 6/

    5 vw. > vws.

    7208D........................ X-ray exam entire spi 6/ 72052........................ X-ray exam neck spine 6/

    > vw. > vws.

    73560........................ X-ray exam of knee 1 or 73560........................ X-ray exam of knee 1 or

    2. 2.

    73562........................ X-ray exam of knee 3.... 73562........................ X-ray exam of knee 3.

    73564........................ X-ray exam knee 4 or 73564........................ X-ray exam knee 4 or

    more. more.

    73565........................ X-ray exam of knees..... 73565........................ X-ray exam of knees.

    73590........................ X-ray exam of lower leg. 73590........................ X-ray exam of lower leg.

    73600........................ X-ray exam of ankle..... 73600........................ X-ray exam of ankle.

    77402........................ Radiation treatment G6003........................ Radiation treatment

    delivery. delivery.

    77407........................ Radiation treatment G6007........................ Radiation treatment

    delivery. delivery.

    77412........................ Radiation treatment G6011........................ Radiation treatment

    delivery. delivery.

    77385........................ Ntsty modul rad tx dlvr G6015........................ Radiation tx delivery

    smpl. imrt.

    Page 41766

    77386........................ Ntsty modul rad tx dlvr G6015........................ Radiation treatment

    cplx. delivery.

    77387........................ Guidance for radiaj tx 77014........................ Ct scan for therapy

    dlvr. guide.

    76948........................ Echo guide ova 76948........................ Echo guide ova

    aspiration. aspiration.

    7778A........................ Hdr rdncl skn surf 77785........................ Hdr brachytx 1 channel.

    brachytx.

    7778B........................ Hdr rdncl skn surf 77786........................ Hdr brachytx 2-12

    brachytx. channel.

    7778C........................ Hdr rdncl ntrstl/icav 77785........................ Hdr brachytx 1 channel.

    brchtx.

    7778D........................ Hdr rdncl ntrstl/icav 77786........................ Hdr brachytx 2-12

    brchtx. channel.

    7778E........................ Hdr rdncl ntrstl/icav 77787........................ Hdr brachytx over 12

    brchtx. chan.

    88346........................ Immunofluorescent study. 88346........................ Immunofluorescent study.

    8835X........................ Immunofluor antb addl 88346........................ Immunofluorescent study.

    stain.

    88367........................ Insitu hybridization 88367........................ Insitu hybridization

    auto. auto.

    88368........................ Insitu hybridization 88368........................ Insitu hybridization

    manual. manual.

    91200........................ Liver elastography...... 91200........................ Liver elastography.

    9254A........................ Caloric vestibular test 92540........................ Basic vestibular

    with recording. evaluation.

    9254B........................ Caloric vestibular test 92540........................ Basic vestibular

    with recording. evaluation.

    99497........................ Advncd care plan 30 min. 99214........................ Office/outpatient visit

    est.

    99498........................ Advncd care plan addl 30 99214........................ Office/outpatient visit

    min. est.

    ----------------------------------------------------------------------------------------------------------------

    Note: For any codes not included in Table 14, we are proposing to use the utilization crosswalk, when a

    crosswalk exists, in order to calculate the malpractice risk factor for these services, as discussed in the

    preamble text.

    a. Lower GI Endoscopy Services

    CPT revised the lower gastrointestinal endoscopy code set for CY 2015 following identification of some of the codes as potentially misvalued and the affected specialty society's contention that this code set did not allow for accurate reporting of services based upon current medical practice. The RUC subsequently provided recommendations to us for valuing these services. In the CY 2015 PFS final rule with comment period, we delayed valuing the lower GI codes and indicated that we would propose values for these codes in the CY 2016 proposed rule, citing the new process for including proposed values for new, revised and potentially misvalued codes in the proposed rule as one of the reasons for the delay.

    (1) Gastrointestinal (GI) Endoscopy (CPT Codes 43775, 44380-46607 and HCPCS Codes G0104, G0105, and G0121)

    In the CY 2014 PFS final rule with comment period, we indicated that we used what we called an ``incremental difference methodology'' in valuing the upper GI codes for that year. We explained that the RUC made extensive use of a methodology that uses the incremental difference in codes to determine values for many of these services. This methodology uses a base code or other comparable code and considers what the difference should be between that code and another code by comparing the differentials to those for other sets of similar codes. As with the esophagoscopy subfamily, many of the procedures described within the colonoscopy subfamily have identical counterparts in the esophagogastroduodenoscopy (EGD) subfamily. For instance, the base colonoscopy CPT code 45378 is described as ``Colonoscopy, flexible; diagnostic, including collection of specimen(s) by brushing or washing when performed, (separate procedure).'' The base EGD CPT code 43235 is described as ``Esophagogastroduodenoscopy, flexible, transoral; diagnostic, with collection of specimen(s) by brushing or washing, when performed.'' In valuing other codes within both subfamilies, the RUC frequently used the difference between these two base codes as an increment for measuring the difference in work involved in doing a similar procedure utilizing colonoscopy versus utilizing EGD. For example, the EGD CPT code 43239 includes a biopsy in addition to the base diagnostic EGD CPT code 43235. The RUC valued this by adding the incremental difference in the base colonoscopy code over the base EGD CPT code to the value it recommended for the esophagoscopy biopsy, CPT code 43202. With some variations, the RUC used this incremental difference methodology extensively in valuing subfamilies of codes. We have made use of similar methodologies in establishing work RVUs for codes in this family.

    We agreed with several of the RUC recommendations for codes in this family. Where we did not agree, we consistently applied the incremental difference methodology. Table I7 reflects how we applied this methodology and the values we are proposing. To calculate the base RVU for the colonoscopy subfamily, we looked at the current intraservice time for CPT code 45378, which is 30 minutes, and the current work RVU, which is 3.69. The RUC recommended an intraservice time of 25 minutes and 3.36 RVUs. We then compared that service to the base EGD CPT code 43235 for which the RUC recommended a work RVU of 2.26, giving an increment between EGD and colonoscopy of 1.10 RVUs. We added that increment to our proposed work RVU for CPT 43235 of 2.19 to arrive at our proposed work RVU for the base colonoscopy CPT code 45378 of 3.29. We use this value as the base code in the incremental methodology for establishing the work value for the other base codes in the colonoscopy subfamilies which were then used to value the other codes in that subfamily.

    Table 15--Application of the Incremental Difference Methodology

    --------------------------------------------------------------------------------------------------------------------------------------------------------

    Current Increment Calculated

    HCPCS Descriptor WRVU RUC WRVU Base procedure Base RVU Increment value WRVU

    --------------------------------------------------------------------------------------------------------------------------------------------------------

    44380........... Ileoscopy, through 1.05 0.97 Colonoscopy........... 3.29 Colonoscopy to -2.39 0.9

    stoma; diagnostic, Ileoscopy.

    including collection

    of specimen(s) by

    brushing or washing,

    when performed.

    Page 41767

    44382........... Ileoscopy, through 1.27 1.27 Ileoscopy............. 0.9 Biopsy............... 0.3 1.2

    stoma; with biopsy,

    single or multiple.

    44384........... Ileoscopy, through NA 3.11 Ileoscopy............. 0.9 Stent................ 1.98 2.88

    stoma; with placement

    of endoscopic stent

    (includes pre- and

    post-dilation and

    guide wire passage,

    when performed).

    44385........... Endoscopic evaluation 1.82 1.3 Colonoscopy........... 3.29 Colonoscopy to endo. -2.06 1.23

    of small intestinal eval.

    pouch (eg, Kock

    pouch, ileal

    reservoir S or J);

    diagnostic, including

    collection of

    specimen(s) by

    brushing or washing,

    when performed.

    44386........... Endoscopic evaluation 2.12 1.6 Endo. Eval............ 1.23 Biopsy............... 0.3 1.53

    of small intestinal

    pouch (eg, Kock

    pouch, ileal

    reservoir S or J);

    with biopsy, single

    or multiple.

    44388........... Colonoscopy through 2.82 2.82 Colonoscopy........... 3.29 Colonoscopy to -0.54 2.75

    stoma; diagnostic, Colonoscopy through

    including collection stoma.

    of specimen(s) by

    brushing or washing,

    when performed

    (separate procedure).

    44389........... Colonoscopy through 3.13 3.12 Colonoscopy through 2.75 Biopsy............... 0.3 3.05

    stoma; with biopsy, stoma.

    single or multiple.

    44390........... Colonoscopy through 3.82 3.82 Colonoscopy through 2.75 Foreign body......... 1.02 3.77

    stoma; with removal stoma.

    of foreign body.

    44402........... Colonoscopy through 4.7 4.96 Colonoscopy through 2.75 Stent................ 1.98 4.73

    stoma; with stoma.

    endoscopic stent

    placement (including

    pre- and post-

    dilation and

    guidewire passage,

    when performed).

    44403........... Colonoscopy through NA 5.81 Colonoscopy through 2.75 Endoscopic mucosal 2.78 5.53

    stoma; with stoma. resection.

    endoscopic mucosal

    resection.

    44404........... Colonoscopy through NA 3.13 Colonoscopy through 2.75 Submucosal injection. 0.3 3.05

    stoma; with directed stoma.

    submucosal

    injection(s), any

    substance.

    45330........... Sigmoidoscopy, 0.96 0.84 Colonoscopy........... 3.29 Colonoscopy to -2.52 0.77

    flexible; diagnostic, Sigmoidoscopy.

    including collection

    of specimen(s) by

    brushing or washing

    when performed.

    45331........... Sigmoidoscopy, 1.15 1.14 Sigmoidoscopy......... 0.77 Biopsy............... 0.3 1.07

    flexible; with

    biopsy, single or

    multiple.

    45332........... Sigmoidoscopy, 1.79 1.85 Sigmoidoscopy......... 0.77 Foreign body......... 1.02 1.79

    flexible; with

    removal of foreign

    body.

    45335........... Sigmoidoscopy, 1.46 1.15 Sigmoidoscopy......... 0.77 Submucosal injection. 0.3 1.07

    flexible; with

    directed submucosal

    injection(s), any

    substance.

    45341........... Sigmoidoscopy, 2.6 2.43 Sigmoidoscopy......... 0.77 Endoscopic ultrasound 1.38 2.15

    flexible; with

    endoscopic ultrasound

    examination.

    Page 41768

    45346........... Sigmoidoscopy, NA 2.97 Sigmoidoscopy......... 0.77 Ablation............. 2.07 2.84

    flexible; with

    ablation of tumor(s),

    polyp(s), or other

    lesion(s) (includes

    pre- and post-

    dilation and guide

    wire passage, when

    performed).

    45347........... Sigmoidoscopy, NA 2.98 Sigmoidoscopy......... 0.77 Stent................ 1.98 2.75

    flexible; with

    placement of

    endoscopic stent

    (includes pre- and

    post-dilation and

    guide wire passage,

    when performed).

    45349........... Sigmoidoscopy, NA 3.83 Sigmoidoscopy......... 0.77 Endoscopic mucosal 2.78 3.55

    flexible; with resection.

    endoscopic mucosal

    resection.

    45378........... Colonoscopy, flexible; 3.69 3.36 Colonoscopy........... 3.29

    diagnostic, including

    collection of

    specimen(s) by

    brushing or washing,

    when performed,

    (separate procedure).

    45379........... Colonoscopy, flexible; 4.68 4.37 Colonoscopy........... 3.29 Foreign body......... 1.02 4.31

    with removal of

    foreign body.

    45380........... Colonoscopy, flexible, 4.43 3.66 Colonoscopy........... 3.29 Biopsy............... 0.3 3.59

    proximal to splenic

    flexure; with biopsy,

    single or multiple.

    45381........... Colonoscopy, flexible; 4.19 3.67 Colonoscopy........... 3.29 Submucosal injection. 0.3 3.59

    with directed

    submucosal

    injection(s), any

    substance.

    45389........... Colonoscopy, flexible; NA 5.5 Colonoscopy........... 3.29 Stent................ 1.98 5.27

    with endoscopic stent

    placement (includes

    pre- and post-

    dilation and guide

    wire passage, when

    performed).

    45390........... Colonoscopy, flexible; NA 6.35 Colonoscopy........... 3.29 Endoscopic mucosal 2.78 6.07

    with endoscopic resection.

    mucosal resection.

    45391........... Colonoscopy, flexible; 5.09 4.95 Colonoscopy........... 3.29 Endoscopic ultrasound 1.38 4.67

    with endoscopic

    ultrasound

    examination limited

    to the rectum,

    sigmoid, descending,

    transverse, or

    ascending colon and

    cecum, and adjacent

    structures.

    --------------------------------------------------------------------------------------------------------------------------------------------------------

    (2) Laparoscopic Sleeve Gastrectomy (CPT Code 43775)

    Prior to CY 2013, CPT code 43775 described a non-covered service. For CY 2013, this service was covered as part of the bariatric surgery National Coverage Determination (NCD) and has been contractor-priced since 2013. We are now proposing to establish national pricing for CPT code 43775. To establish a work RVU, we are crosswalking this code to CPT code 37217 (Transcatheter placement of an intravascular stent(s), intrathoracic common carotid artery or innominate artery by retrograde treatment, via open ipsilateral cervical carotid artery exposure, including angioplasty, when performed, and radiological supervision and interpretation), due to their identical intraservice times, similar total times, and similar levels of intensity. Therefore, we are proposing a work RVU of 20.38 for CPT code 43775.

    (3) Incomplete Colonoscopy (CPT codes 44388, 45378, G0105, and G0121)

    Prior to CY 2015, according to CPT instruction, an incomplete colonoscopy was defined as a colonoscopy that did not evaluate the colon past the splenic flexure (the distal third of the colon). In accordance with that definition, the Medicare Claims Processing Manual (pub. 100-04, chapter 12, section 30.1.B., available at http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items) states that physicians should report an incomplete colonoscopy with 45378 and append modifier -53, which is paid at the same rate as a sigmoidoscopy.

    In CY 2015, the CPT instruction changed the definition of an incomplete colonoscopy to a colonoscopy that does not evaluate the entire colon. The 2015 CPT Manual states, ``When performing a diagnostic or screening endoscopic procedure on a patient who is scheduled and prepared for a total colonoscopy, if the physician is unable to advance the colonoscope to the

    Page 41769

    cecum or colon-small intestine anastomosis due to unforeseen circumstances, report 45378 (colonoscopy) or 44388 (colonoscopy through stoma) with modifier -53 and provide appropriate documentation.''

    Given that the new definition of an incomplete colonoscopy also includes colonoscopies where the colonoscope is advanced past the splenic flexure but not to the cecum, we are proposing to establish new values for the incomplete colonoscopies, reported with the -53 modifier. At present, we crosswalk the RVUs for the incomplete colonoscopies from the values of the corresponding sigmoidoscopy. Given that the new CPT instructions will reduce the number of reported complete colonoscopies and increase the number of colonoscopies that proceeded further toward completion reported with the -53 modifier, we believe CPT code 45378 reported with the -53 modifier will now describe a more resource-intensive group of services than were previously reported. Therefore, we are proposing to develop RVUs for these codes reported with the -53 modifier by using one-half the value of the inputs for the corresponding codes reported without the -53 modifier.

    In addition to this proposed change in input values, we are also seeking comment on how to address the disparity of resource costs among the broader range of services now described by the colonoscopy codes billed with the -53 modifier. We believe that it may be appropriate for practitioners to report the sigmoidoscopy CPT code 45330 under circumstances when a beneficiary is scheduled and prepared for a total colonoscopy (diagnostic colonoscopy, screening colonoscopy or colonoscopy through stoma), but the practitioner is unable to advance the colonoscope beyond the splenic flexure. We are seeking comment and recommendations on that possibility, as well as more generally, the typical resource costs of these incomplete colonoscopy services under CPT's new definition. Finally, we are seeking information regarding the number of colonoscopies that will be considered incomplete under CPT's new definition relative to the old definition, as well as the number of incomplete colonoscopies where the practitioner is unable to advance the colonoscope beyond the splenicflexure. This information will help us determine whether or not differential payment is required, and if it is, how to make the appropriate utilization assumptions within our ratesetting process.

    (4) Malpractice (MP) Crosswalk

    We examined the RUC's recommended MP crosswalk for this family of codes. The MP crosswalks are used to identify the presumed mix of specialties that furnish particular services until there is Medicare claims data for the new codes. We direct the reader to section II.B.1. of this proposed rule for further explanation regarding these crosswalks. In reviewing the recommended MP crosswalks for CPT codes 43775, 44407, 44408, 46601, and 46607, we noted that the RUC-

    recommended MP crosswalk codes are inconsistent with our analysis of the specialties likely to furnish the service based on the description of the services and our review of the RUC-recommended utilization crosswalk. The inconsistency between the RUC's recommended MP and utilization crosswalks is not altogether unusual. However when there are discrepancies between the MP and utilization crosswalk recommendations, they generally reflect the RUC's expectation that due to changes in coding, there will be a different mix of specialties reporting a new code than might be reflected in the claims data for the code previously used to report that service. This often occurs when the new coding structure for a particular family of services is either more or less specific than the old set of codes. In most of these cases, we could identify a rationale for why the RUC's recommended MP crosswalks for these codes were likely to be more accurate than the RUC's recommended utilization crosswalk. But in the case of these codes, the reason for the discrepancies were neither apparent nor explained as part of the recommendation. Since the specialty mix in the claims data is used to determine the specialty mix for each HCPCS code for the purposes of calculating MP RVUs, and that data will be used to set the MP RVUs once it is available, we believe using a specialty mix derived from the claims data of the predecessor codes is more likely to be accurate than the RUC-recommended MP crosswalk as well as more likely to result in stable MP RVUs for these services over several years. Therefore, until claims data under the new set of codes is available, we are proposing to use the specialty mix of the source code(s) in the RUC-recommended utilization crosswalk in order to calculate the malpractice risk factor for these services instead of the RUC-

    recommended MP crosswalk. Once claims data are available, those data will be incorporated into the calculation of MP RVUs for these services under the MP RVU methodology.

    b. Radiation Treatment and Related Image Guidance Services

    For CY 2015, the CPT Editorial Panel revised the set of codes that describe radiation treatment delivery services based in part on the CMS identification of these services as potentially misvalued in CY 2012. We identified these codes as potentially misvalued under a screen called ``Services with Stand-Alone PE Procedure Time.'' We proposed this screen following our discovery of significant discrepancies between the RUC-recommended 60 minute procedure time assumptions for intensity modulated radiation therapy (IMRT) and information available to the public suggesting that the procedure typically took between 5 and 30 minutes per treatment.

    The CPT Editorial Panel's revisions included the addition and deletion of several codes and the development of new guidelines and coding instructions. Four treatment delivery codes (77402, 77403, 77404, and 77406) were condensed into 77402 (Radiation Treatment Delivery, Simple), three treatment delivery codes (77407, 77408, 77409) were condensed into 77407 (Radiation treatment delivery, intermediate), and four treatment codes (77412, 77413, 77414, 77416) were condensed into 77412 (Radiation treatment delivery, complex). Intensity Modulated Radiation Therapy (IMRT) treatment delivery, previously reported under a single code, was split into two codes, 77385 (IMRT treatment delivery, simple) and 77386 (IMRT treatment delivery, complex). The CPT Editorial Panel also created a new image guidance code, 77387 (Guidance for localization of target volume for delivery of treatment, includes intrafraction tracking when performed) to replace 77014 (computed tomography guidance for placement of radiation therapy fields), 77421 (stereoscopic X-ray guidance for localization of target volume for the delivery of radiation therapy,) and 76950 (ultrasonic guidance for placement of radiation therapy fields) when any of these services were furnished in conjunction with radiation treatment delivery.

    In response to stakeholder concerns regarding the magnitude of the coding changes and in light of the process changes we adopted for valuing new and revised codes, we did not implement interim final values for the new codes and delayed implementing the new code set until 2016. To address the valuation of the new code set through proposed rulemaking, and

    Page 41770

    continue making payment based the previous valuations even though CPT deleted the prior radiation treatment delivery codes for CY 2015, we created G-codes that mimic the predecessor CPT codes (79 FR 67667).

    We propose to establish values for the new codes based on RUC recommendations, subject to standard CMS refinements that appear in Table 15 in section II.B.4. of this proposed rule. We also note that because the invoices used to price the capital equipment included ``on-

    board imaging,'' the cost of that equipment is already reflected in the price per minute associated with the capital equipment. Therefore, we have not included it as a separate item in the proposed direct PE inputs for these codes, even though it appeared as a separate item on the PE worksheet included with the RUC recommendations for these codes. The direct PE inputs for these codes are reflected in the proposed direct PE input database available on the CMS Web site under the supporting data files for the CY 2016 PFS proposed rule with comment period at http://www.cms.gov/PhysicianFeeSched/. The RVUs that result from the use of these proposed direct PE inputs (and work RVUs and work time, as applicable) are displayed in Addendum B on the CMS Web site.

    In addition to the refinements addressed above, there are three additional issues for which we are seeking comment and/or making specific proposals related to these services: image guidance, equipment utilization rate assumptions for linear accelerators, and superficial radiation treatment services.

    (1) Image Guidance Services

    Under the previous CPT coding structure, image guidance was separately billable when furnished in conjunction with the radiation treatment delivery services. The image guidance was reported using different CPT codes, depending on which image guidance modality was used. These codes were split into professional and/or technical components that allowed practitioners to report a single component or the global service. The professional component of each of these codes included the work of the physician furnishing the image guidance. CPT code 77014, used to report CT guidance, had a work RVU of 0.85; CPT code 77421, used to report stereotactic guidance, had a work RVU of 0.39, and CPT code 76950, used to report ultrasonic guidance, had a work RVU of 0.58. The technical component of these codes incorporated the resource costs of the image guidance capital equipment (such as CT, ultrasound, or stereotactic) and the clinical staff involved in furnishing the image guidance associated with the radiation treatment. When billed globally, the RVUs reflected the sum of the professional and technical components. In the revised coding structure, one new image guidance code is to be reported regardless of the modality used, and in developing its recommended values, the RUC assumed that CT guidance would be typical.

    However, the 2013 Medicare claims data for separately reported image guidance indicates that stereotactic guidance for radiation treatment services was furnished more frequently than CT guidance. The RUC has recommended a work RVU of 0.58 and associated work times of 3 pre-service minutes, 10 intraservice minutes, and 3 post-service minutes for image guidance CPT code 77387. We reviewed this recommendation considering the discrepancy between the modality the RUC assumed to be typical in the vignette and the modality typically reported in the Medicare claims data. Given that the recommended work RVU for the new single code is similar to the work RVUs of the predecessor codes, roughly prorated based on their distribution in Medicare claims data, we agree with the RUC-recommended work RVU for the service. However, the RUC also recommended an increase in overall work time associated with image guidance consistent with the survey data used to value the new services. If accurate, this increase in time and maintenance of total work would suggest a decrease in the overall intensity for image guidance relative to the current codes. Given this implication, we are seeking comment as to the appropriate work time associated with CPT code 77387.

    Although 77421 (stereotactic guidance) and 76950 (ultrasonic guidance) have been deleted, we note that CPT maintained CPT code 77014 (Computed tomography guidance for placement of radiation therapy fields) and the RUC recommendation states that CPT did so based on concerns that without this option, some practitioners might have no valid CPT alternative than to use higher valued diagnostic CT codes when they used this CT guidance. The RUC recommendation also includes a statement that utilization of this code is expected to drop to negligible levels by 2015, assuming that practitioners would use the new codes that are not differentiated based on imaging modality. Once all the new codes are implemented for Medicare, we anticipate that CPT and/or the RUC will address the continued use of 77014 and, if it continues to be part of the code set, provide recommendations as to the appropriate values given changes in utilization.

    Regarding the reporting of the new image guidance codes, CPT guidance instructs that the technical portion of image guidance is now bundled into the IMRT and Stereotactic Radiation Treatment delivery codes, but it is not bundled into the simple, intermediate, and complex radiation treatment delivery codes. CPT guidance states that the technical component of the image guidance code can be reported with codes 77402, 77407, and 77412 (simple, intermediate, and complex radiation treatment) when furnished, which means that the technical component of the image guidance code should not be reported with the IMRT or Stereotactic Radiation Treatment delivery codes. The RUC recommendation, however, incorporates the same capital cost of image guidance equipment (a linear accelerator, or linac), for all these radiation treatment delivery codes, including the codes that describe IMRT and Stereotactic Radiation Treatment delivery services. The RUC explains that the recommendations were done this way because the older lower-dose external beam radiation machines are no longer manufactured and the image guidance technology is integrated into the single kind of linear accelerator used for all the radiation treatment services. In reviewing the new code structure and the RUC recommendations, we assume that the CPT editorial panel did not foresee that the RUC would recommend that we develop PE RVUs for all the radiation treatment delivery codes based on the assumption that the same capital equipment is typically used in furnishing the entire range of external beam radiation treatments. Because the RUC recommendations incorporate the more extensive capital equipment in the lower dose treatment codes as well, a portion of the resource costs of the technical portion of imaging guidance are already allocated into the PE RVUs for all of the treatment delivery codes, not just the IMRT and Stereotactic Radiation Treatment delivery codes as CPT guidance would suggest.

    In order to avoid incorporating the cost of this equipment into both the treatment delivery codes (77402, 77407, and 77412) and the technical component of the new imaging guidance code (77387-TC), we considered valuing 77387 as a professional service only and not creating the professional/technical component splits envisioned by CPT. In the context of the budget neutral PFS, incorporating a duplicative

    Page 41771

    direct input with a cost of more than six dollars per minute has significant impacts on the PE RVUs for all other services. However, we also noted that the RUC did not address this apparent contradiction in its recommendation and not all of the recommended direct PE inputs for the technical component of 77387 are capital equipment costs. Therefore, we are proposing to allow for professional and technical component billing for these services, as reflected in CPT guidance, and we are proposing to use the RUC recommended direct PE inputs for these services (refined as described in Table 15). However, we are also seeking comment on the apparent contradiction between technical component billing for image guidance in the context of the inclusion of a single linac with integrated imaging guidance technology being included for all external beam treatment codes.

    (2) Equipment Utilization Rate for Linear Accelerators

    The cost of the capital equipment is the primary determining factor in the payment rates for these services. For each CPT code, the equipment costs are estimated based on multiplying the assumed number of minutes the equipment is used for that procedure by the per minute cost of the particular equipment item. Under our PE methodology, we currently use two default equipment usage assumptions in allocating capital equipment costs to calculate PE RVUs. The first is that each equipment item is only available to be used during what are assumed to be regular business hours for a physician's office: 10 hours per day, 5 days per week (50 hours per week) and 50 weeks per year. The second assumption is that the equipment is in use only 50 percent of the time that it is available for use. The current default 50 percent utilization rate assumption translates into 25 hours per week out of a 50-hour work week.

    We have previously addressed the accuracy of these default assumptions as they apply to particular equipment resources and particular services. In the CY 2008 PFS proposed rule (72 FR 38132) we discussed the 50 percent utilization assumption and acknowledged that the default 50 percent usage assumption is unlikely to capture the actual usage rates for all equipment. However, we stated that we did not believe that we had strong empirical evidence to justify any alternative approaches. We indicated that we would continue to monitor the appropriateness of the equipment utilization assumption, and evaluate whether changes should be proposed in light of the data available.

    Subsequently, a 2009 report on equipment utilization by MedPAC included studies that suggested a higher utilization rate for diagnostic imaging equipment costing more than $1 million. These studies cited by MedPAC suggested that for Magnetic Resonance Imaging equipment, a utilization rate of 92 percent on a 50-hour week would be most accurate. Similarly, another MedPAC cited study suggested that for Computed Tomography scanners, 45 hours was more accurate and that is equivalent to a 90 percent utilization rate on a 50-hour work week. For the CY 2010 PFS proposed rule, we proposed to increase the equipment usage rate to 90 percent for all services containing equipment that cost in excess of $1 million dollars. We stated that the studies cited by MedPAC suggested that physicians and suppliers would not typically make huge capital investments in equipment that would only be utilized 50 percent of the time (74 FR 33532).

    In response to comments to that proposal, we finalized a 90 percent utilization rate assumption for MRI and CT to be transitioned over a 4-

    year period. Regarding the utilization assumptions for other equipment priced over $1 million, we stated that we would continue to explore data sources regarding use of the most accurate utilization rates possible (74 FR 61755). Congress subsequently specified the utilization rate to be assumed for MRI and CT by successive amendments to Section 1848(b)(4)(C) of the Act. Section 3135(a) of the Affordable Care Act (Pub. L. 111-148) set the assumed utilization rate for expensive diagnostic imaging equipment to 75 percent, effective for 2011 and subsequent years. Section 635 of the American Taxpayer Relief Act (ATRA) (Pub. L. 112-240) set the assumed equipment utilization rate to 90%, effective for 2014 and subsequent years. Both of these changes were exempted from the budget neutrality requirements described in section 1848(c)(2)(B)(ii)(II) of the Act.

    We have also made other adjustments to the default assumptions regarding the number of hours for which the equipment is available to be used. For example, some equipment used in furnishing services to Medicare beneficiaries is available to be used on a 24-hour/day, 7 days/per week basis. For these items, we develop the rate per minute by amortizing the cost over the extended period of time the equipment is in use.

    Based on the RUC recommendations for the new codes that describe radiation treatment services, we do not believe our default assumptions regarding equipment usage are accurate for the capital equipment used in radiation treatment services. As we noted above, the RUC recommendations assume that the same type of linear accelerator is now typically used to furnish all levels and types of external beam radiation treatment services because the machines previously used to furnish these services are no longer manufactured. In valuing the previous code set and making procedure time assumptions, different equipment items were assumed to be used to furnish the different levels and types of radiation treatment. With the current RUC-recommended inputs, we can then assume that the same equipment item is used to furnish more services. If we assume the RUC recommendation to include the same kind of capital equipment for all of these codes is accurate, we believe that it is illogical to continue to assume that the equipment is only used for 25 out of a possible 50 hours per week. In order to estimate the difference between the previous number of minutes the linear accelerator was assumed to be in use under the previous valuation and the number of minutes now being recommended, we applied the change in assumptions to the services reported in the most recent year of Medicare claims data. Under the assumptions reflected in the previous direct PE inputs, the kind of linear accelerator used for IMRT made up a total of 44.8 million out of 65 million minutes of external beam treatments furnished to Medicare beneficiaries. Under the new code set, however, a single kind of linear accelerator would be used for all of the 65 million minutes furnished to Medicare beneficiaries. This represents a 45 percent increase in the aggregate amount of time that this kind of linac is in use. Of course, the utilization rate that corresponds with that increase in minutes is not necessarily precise since the current utilization rate only reflects the default assumption and is not itself rooted in empirical data. Additionally, in some cases, individual practices that already use linear accelerators for IMRT may have replaced the now-obsolete capital equipment with new, additional linear accelerators instead of increasing the use of capital equipment already owned. However, we do not believe that the latter scenario is likely to be common in cases where the linear accelerators had previously been used only 25 hours per week.

    Therefore, we are proposing to adjust the equipment utilization rate

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    assumption for the linear accelerator to account for the significant increase in usage. Instead of applying our default 50 percent assumption, we are proposing to use a 70 percent assumption based on the recognition that the item is now being typically used in a significantly broader range of services, and that would increase its overall usage in comparison to the previous assumption. We note that we developed the 70 percent rate based on a rough reconciliation between the number of minutes the equipment is being used according to the new recommendations versus the current number of minutes based on an analysis of claims data. We continue to seek evidence to ensure that the usage assumptions, both the utilization rate and number of available hours, used to calculate equipment costs are as accurate as possible. We believe that comparing the changes in direct PE input recommendations and using the Medicare claims data indicates that the utilization assumption to 70 percent is more accurate than the default utilization assumption of 50 percent. However, we have reviewed other information that suggests this utilization rate may be higher than 70 percent and that the number of available hours per week is greater than 50.

    For example, as part of the 2014 RUC recommendations for the Radiation Treatment Delivery codes, the RUC submitted a 2011 staffing survey conducted by the American Society for Radiology Technicians (ASRT). Using the 2014 version of the same study, we noted that there are an average of 2.3 linacs per radiation treatment facility and 52.7 patients per day treated per radiation treatment facility. These data suggest that an average of 22.9 patients is treated on each linac per day. Using an average of the RUC-recommended procedure times for CPT codes 77385, 77386, 77402, 77407, and 77412 weighted by the annual volume of procedures derived from Medicare claims data yielded a total of 670.39 minutes or 11.2 hours that a single linac is in use per day. This is in contrast to both the number of hours of use reflected in our default assumptions (5 of the 10 available business hours per day) and in our proposed revision to the equipment utilization rate assumption (7 hours out of 10 available business hours per day).

    For advanced diagnostic imaging services, we finalized a policy to change the equipment utilization assumption only by 10 percent per year, in response to suggestions from commenters. Because capital equipment costs are amortized over several years, we believe it is reasonable to transition changes to the default assumptions for particular items over several years. We note that the change from one kind of capital equipment to another is likely to occur over a number of years, roughly equivalent to the useful life of particular items as they become obsolete. In the case of most of these items, we have assumed a 7-year useful life, and therefore, we assume that the transition to use of the single kind of capital equipment would likely take place over 7 years as individual pieces of equipment age into obsolescence. However, in the case of this transition in capital equipment, we have reasons to believe that the transition to the new capital equipment has already occurred. First, we note that the specialty societies concluded that the single linear accelerator was typical for these services at the time that the current recommendations were developed in 2013. Therefore, we believe it is logical to assume that, at a minimum, the first several years of the transition to new capital equipment had already taken place by 2013. This would account for the linear accelerator being typically used at that time. This would not be surprising, given that prior to the 2013 review by the RUC, the codes describing the non-IMRT external beam radiation treatments had last been reviewed in 2002. Second, because we are proposing to use the 2013 recommendations for 2016 PFS payment rates, we believe it would be reasonable to assume that in the years between 2013 and 2016, the majority of the rest of the obsolete machines would have been replaced with the single linear accelerator.

    Nonetheless, we recognize that there would be value in following precedent to transition changes in utilization assumptions over several years.

    Given the fact that it is likely that the transition to the linear accelerator began prior to the 2013 revaluation of the radiation treatment delivery codes by CPT and that the useful life of the newest generation of linear accelerator is 7 years, we believe a 2-year transition to the 70 percent utilization rate assumption would account for any remaining time to transition to the new equipment. Therefore, in developing PE RVUs for these services, we are proposing to use a 60 percent utilization rate assumption for CY 2016 and a 70 percent utilization rate assumption for CY 2017. The PE RVUs displayed in addendum B on the CMS Web site were calculated using the proposed 60 percent equipment utilization rate for the linac as displayed in the CY 2016 direct PE input database.

    Additionally, we continue to seek empirical data on the capital equipment costs, including equipment utilization rates, for the linac and other capital-intensive machines, and seek comment on how to most accurately address issues surrounding those costs within the PE methodology.

    (3) Superficial Radiation Treatment Delivery

    In the CY 2015 PFS final rule with comment period, we noted that changes to the CPT prefatory language modify the services that are appropriately billed with CPT code 77401 (radiation treatment delivery, superficial and/or ortho voltage, per day). The changes effectively meant that many other procedures supporting superficial radiation therapy were bundled with 77401. The RUC, however, did not review the inputs for superficial radiation therapy procedures, and therefore, did not assess whether changes in its valuation were appropriate in light of this bundling. Some stakeholders suggested that the change in the prefatory language precluded them from billing for codes that were previously frequently billed in addition to this code and expressed concern that as a result there would be significant reduction in their overall payments. In the CY 2015 PFS final rule with comment period, we requested information on whether the new radiation therapy code set combined with modifications in prefatory text allowed for appropriate reporting of the services associated with superficial radiation and whether the payment continued to reflect the relative resources required to furnish superficial radiation therapy services.

    In response to our request, we received a recommendation from a stakeholder to make adjustments to both the physician work and PE components for code 77401. The stakeholder suggested that since crucial aspects of the service, such as treatment planning and device design and construction, were not currently reflected in 77401, and practitioners were precluded from reporting these activities separately, that physician work should be included for CPT code 77401. Additionally, the stakeholders suggested that the current inputs used to value the code are not accurate because the inputs include zero physician work and minutes for a radiation therapist to provide the service directly to the patient. The stakeholders suggested, alternatively, that physicians, not radiation therapists, typically provide superficial radiation services directly. Therefore, we are seeking recommendations from other stakeholders, including the RUC, regarding whether or not it would be

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    appropriate to add physician work for this service and remove minutes for the radiation therapists, even though physician work is not included in other radiation treatment services.

    The stakeholder also suggested that we amend the direct PE inputs by including nurse time and updating the price of the capital equipment used in furnishing the service. We believe it would be most appropriate to address the clinical labor assigned to the code in the context of the information regarding the physician work that might be associated with the service. Therefore, we seek information on the possible inclusion of nurse time for this service as part of the comments and/or recommendations regarding physician work for the service. However, we reviewed the submitted invoices for the request to update the capital equipment for the service. We are proposing to update the equipment item ER045 ``orthovoltage radiotherapy system'' by renaming it ``SRT-

    100 superficial radiation therapy system'' and updating the price from $140,000 to $216,000, on the basis of the submitted invoices. The PE RVUs displayed in Addendum B on the CMS Web site were calculated with this proposed modification that is displayed in the CY 2016 direct PE input database.

    c. Advance Care Planning Services

    For CY 2015, the CPT Editorial Panel created two new codes describing advance care planning (ACP) services: CPT code 99497 (Advance care planning including the explanation and discussion of advance directives such as standard forms (with completion of such forms, when performed), by the physician or other qualified health professional; first 30 minutes, face-to-face with the patient, family member(s) and/or surrogate); and an add-on CPT code 99498 (Advance care planning including the explanation and discussion of advance directives such as standard forms (with completion of such forms, when performed), by the physician or other qualified health professional; each additional 30 minutes (List separately in addition to code for primary procedure)). In the CY 2015 PFS final rule with comment period (79 FR 67670-71), we assigned a PFS interim final status indicator of ``I'' (Not valid for Medicare purposes. Medicare uses another code for the reporting and payment of these services) to CPT codes 99497 and 99498 for CY 2015. We said that we would consider whether to pay for CPT codes 99497 and 99498 after we had the opportunity to go through notice and comment rulemaking.

    We received many public comments to the final rule recommending that we recognize these two CPT codes and make separate payment for ACP services, in view of the time required to furnish the services and their importance for the quality of care and treatment of the patient. For CY 2016, we are proposing to assign CPT codes 99497 and 99498 PFS status indicator ``A,'' which is defined as: ``Active code. These codes are separately payable under the PFS. There will be RVUs for codes with this status.'' The presence of an ``A'' indicator does not mean that Medicare has made a national coverage determination regarding the service. Contractors remain responsible for local coverage decisions in the absence of a national Medicare policy. We are proposing to adopt the RUC-recommended values (work RVUs, time, and direct PE inputs) for CPT codes 99497 and 99498 beginning in CY 2016 and will consider all public comments that we receive on this proposal.

    Physicians' services are covered and paid by Medicare in accordance with section 1862(a)(1)(A) of the Act. Therefore, CPT code 99497 (and CPT code 99498 when applicable) should be reported when the described service is reasonable and necessary for the diagnosis or treatment of illness or injury. For example, this could occur in conjunction with the management or treatment of a patient's current condition, such as a 68 year old male with heart failure and diabetes on multiple medications seen by his physician for the evaluation and management of these two diseases, including adjusting medications as appropriate. In addition to discussing the patient's short-term treatment options, the patient expresses interest in discussing long-term treatment options and planning, such as the possibility of a heart transplant if his congestive heart failure worsens and advance care planning including the patient's desire for care and treatment if he suffers a health event that adversely affects his decision-making capacity. In this case the physician would report a standard E/M code for the E/M service and one or both of the ACP codes depending upon the duration of the ACP service. However, the ACP service as described in this example would not necessarily have to occur on the same day as the E/M service.

    We seek comment on this proposal, including whether payment is needed and what type of incentives this proposal creates. In addition, we seek comment on whether payment for advance care planning is appropriate in other circumstances such as an optional element, at the beneficiary's discretion, of the annual wellness visit (AWV) under section 1861(hhh)(2)(G) of the Act.

    d. Proposed Valuation of Other Codes for CY 2016

    (1) Excision of Nail Bed (CPT Code 11750)

    The RUC's review of 10-day global services identified 18 services currently valued with greater than 1.5 office visits and 2012 Medicare utilization data over 1,000, including CPT code 11750. As a result, the RUC requested this service be surveyed for work and reviewed for CY 2016.

    The RUC recommended a work RVU of 1.99 for CPT code 11750, despite a decrease in the associated post-operative visits. We believe the recommendation for this service overstates the work involved in performing this procedure specifically given the decrease in post-

    operative visits. Due to similarity in service and time, we believe a direct crosswalk of the work RVUs for CPT code 10140 (Drainage of blood or fluid accumulation), which is also a 10 day global service with one post-operative visit, to CPT code 11750 more accurately reflects the time and intensity of furnishing the service. Therefore, for CY 2016 we are proposing a work RVU of 1.58 for CPT code 11750.

    (2) Bone Biopsy Excisional (CPT Code 20240)

    In the same review of 10-day global services, the RUC identified CPT code 20240 as potentially misvalued. As a result, the RUC requested this service be surveyed and reviewed for CY 2016. Subsequent to this identification, the RUC also requested and we approved a global period change from a 10-day to a 0-day global period for this procedure. Based on the survey data, the RUC recommended a decrease in the intraservice time from 39 to 30 minutes, removal of two postoperative visits (one 99238 and one 99212), and an increase in the work RVUs for CPT code 20240 from 3.28 to 3.73. We do not believe this recommendation accurately reflects the work involved in this procedure, especially given the decrease in intraservice time and post-operative visits. Therefore, for CY 2016, we are proposing a work RVU of 2.61 for CPT code 20240 based on the reductions in time for the service.

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    (3) Endobronchial Ultrasound (CPT Codes 31622, 3160A, 3160B, 31625, 31626, 31628, 31629, 3160C, 31632 and 31633)

    For CY 2016, the CPT Editorial Panel deleted one code, CPT 31620 (Ultrasound of lung airways using an endoscope), and created three new codes, CPT 3160A-3160C, to describe bronchoscopic procedures that are inherently performed with endobronchial ultrasound (EBUS).

    In their review of the newly revised EBUS family, the RUC recommended a change in the work RVU for CPT code 31629 from 4.09 to 4.00. The RUC also recommended maintaining the current work RVUs for CPT codes 31622, 31625, 31626, 31628, 31632 and 31633. We are proposing to use those values for CY 2016.

    For the newly created codes, the RUC recommended a work RVU of 5.00 for CPT code 3160A, 5.50 for CPT code 3160B and 1.70 for CPT code 3160C. We believe the recommended work RVUs for these services overstate the work involved in furnishing the procedures. In order to develop proposed work RVUs for CPT code 3160A, we compared the service described by the new code to deleted CPT codes 31620 and 31629, because this new code describes a service that combines services described by 31620 and 31629. Specifically, we took the sum of the current work RVU of CPT code 31629 (WRVU=4.09) and the CY 2015 work RVU of CPT code 31620 (WRVU=1.40) and multiplied it by the quotient of CPT code 3160A's RUC-recommended intraservice time (INTRA=60 min) and the sum of CPT codes 31620 and 31629's current and CY 2015 intraservice times (INTRA=70 min), respectively. This resulted in a work RVU of 4.71 and we are proposing that value. To value CPT code 3160B, we used the RUC-

    recommended increment of 0.5 work RVU between this service and CPT code 3160A to calculate for CPT code 3160B our proposed work RVUs of 5.21. Lastly, because the service described by new CPT code 3160C is very similar to deleted CPT code 31620, we believe a direct crosswalk of the previous values for 31620 accurately reflects the time and intensity of furnishing the service described by 3160C. Therefore, we are proposing a work RVUs of 1.40 for CPT code 3160C.

    (4) Laparoscopic Lymphadenectomy (CPT Codes 38570, 38571 and 38572)

    The RUC identified three laparoscopic lymphadenectomy codes as potentially misvalued: CPT code 38570 (Laparoscopy, surgical; with retroperitoneal lymph node sampling (biopsy), single or multiple); CPT code 38571 (Laparoscopy, surgical; with retroperitoneal lymph node sampling (biopsy), single or multiple with bilateral total pelvic lymphadenectomy); and CPT code 38572 (Laparoscopy, surgical; with retroperitoneal lymph node sampling (biopsy), single or multiple with bilateral total pelvic lymphadenectomy and periaortic lymph node sampling (biopsy), single or multiple). Accordingly, the specialty society resurveyed these 10-day global codes, and the survey results indicated decreases in intraservice and total work times. After reviewing the survey responses, the RUC recommended that CMS maintain the current work RVU for CPT code 38570 of 9.34; reduce the work RVU for CPT code 38571 from 14.76 to 12.00; and reduce the work RVU for CPT code 38572 from 16.94 to 15.60. We propose to accept the RUC recommendations for CPT codes 38571 and 38572, as the RUC is recommending reductions in the work RVUs that correspond with marked decreases in intraservice time and decreases in total time. However, we do not agree with the RUC's recommendation to maintain the current work RVU for CPT code 38570 in spite of similar changes in intraservice and total times as were shown in the RUC recommendations for CPT codes 38571 and 38572. Therefore, we propose to reduce the work RVU for CPT code 38570 to 8.49, which reflects the ratio of the reduction in total time for this code and would maintain rank order among the three codes.

    (5) Mediastinoscopy With Biopsy (CPT Codes 3940A and 3940B)

    The RUC identified CPT code 39400 (Mediastinoscopy, including biopsy(ies) when performed) as a potentially misvalued code due to an unusually high preservice time and Medicare utilization over 10,000. In reviewing the code's history, it became apparent that the code has been used to report two distinct procedural variations although the code was valued using a vignette for only one of them. As a result, CPT code 39400 is being deleted and replaced with CPT codes 3940A and 3940B to describe each of the two mediastinoscopy procedures.

    We are proposing to accept the RUC-recommended work RVU of 5.44 for code 3940A. We agree with the RUC that the crosswalk from CPT code 52235 (Cystourethroscopy, with fulguration) appropriately estimates the overall work for CPT code 3940A. For CPT code 3940B, we disagree with the RUC recommended work RVU of 7.50. We believe that the work value for CPT code 3940A establishes an accurate baseline for this family of codes, so we are scaling the work RVU of CPT code 3940B in accordance with the change in the intraservice times between CPT codes 3940A and 3940B. Applying this ratio in the intraservice time to the work value of CPT code 3940A yields a total work RVU of 7.25 for CPT code 3940B. We also note that the RUC recommendation for CPT code 3940A represents a decrease in value by 0.64 work RVUs, which is roughly proportionate to the reduction from a full hospital discharge visit (99238) to a half discharge visit assumed to be typical in the post-operative period. The RUC recommendation for CPT code 3940B had the same reduction in the post-operative work without a corresponding decrease in its recommended work RVU. In order to reflect the reduction in post-operative work and to maintain relativity between the two codes in the family, we are proposing 7.25 as the work RVU for CPT code 3940B.

    (6) Hemorrhoid(s) Injection (CPT Code 46500)

    The RUC also identified CPT code 46500 (Injection of sclerosing solution, hemorrhoids) as potentially misvalued, and the specialty society resurveyed this 10-day global code. The survey showed a significant decrease in the reported intraservice and total work times. After reviewing the survey responses, the RUC recommended that CMS should maintain the current work RVU of 1.69 in spite of these drops in intraservice and total times. We propose to instead reduce the work RVU to 1.42, which reduces the work RVU by the same ratio as the reduction in total time.

    We are also proposing to refine the recommended PE inputs by removing the inputs associated with cleaning the scope. As recommended by the RUC, we are proposing to include a scope as a direct PE input that is disposable, and therefore, does not require cleaning.

    (7) Liver Allotransplantation (CPT Code 47135)

    The RUC also identified CPT code 47135 (Liver allotransplantation; orthotopic, partial or whole, from cadaver or living donor, any age) as potentially misvalued, and the specialty society resurveyed this 90-day global code. The survey showed a significant decrease in reported intraservice work time, but a significant increase in total work time (the number of post-operative visits significantly declined while the level of visits increased). After reviewing the survey responses, the

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    RUC recommended an increase in the work RVU from 83.64 to 91.78, which is the median of the survey, as well as the exact value for CPT code 33935 (Heart-lung transplant with recipient cardiectomy-pneumonectomy). However, we do not believe this crosswalk is the most accurate from among the group of transplant codes. CPT code 32854 (Lung transplant, double (bilateral sequential or en bloc); with cardiopulmonary bypass) has intraservice and total times that are closer to those the RUC recommended for CPT code 47135, and CPT code 32854 has a work RVU of 90.00 which is the 25th percentile of the survey for CPT code 47135. Therefore, we propose to increase the work RVU of CPT code 47135 to 90.00.

    (8) Genitourinary Catheter Procedures (CPT Codes 5039A, 5039B, 5039C, 5039D, 5039M, 5039E, 5069G, 5069H, 5069I)

    For CY 2016, the CPT Editorial Panel is deleting six codes (50392, 50393, 50394, 50398, 74475, and 74480) that were commonly reported together, and are creating 12 new codes both to describe these genitourinary catheter procedures more accurately and to bundle inherent imaging services. Three of these codes (506XF, 507XK, and 507XL) were referred back to CPT to be resurveyed as add-on codes. The other nine codes were reviewed at the January 2015 RUC meeting and assigned recommended work RVUs and direct PE inputs.

    We are proposing to use the RUC-recommended work RVU of 3.15 for CPT code 5039A. We agree that this is an appropriate value, and that the code should be used as a basis for establishing relativity with the rest of the family. As a result, we began by making comparisons between the service times of CPT code 5039A and the other codes in the family in order to determine the appropriate proposed work value of each procedure.

    For CPT code 5039B, we disagree with the RUC recommended work RVU of 1.42, and we are instead proposing a work RVU of 1.10, based on three separate data points. First, the RUC summary of recommendations stated that CPT code 5039B describes work previously described by a combination of CPT codes 50394 and 74425. These two codes have work RVUs of 0.76 and 0.36, respectively, which sum together to 1.12. Second, we noted that the work of CPT code 49460 (Mechanical removal of obstructive material from gastrostomy) is similar, with the same intraservice time of 15 minutes and same total time of 55 minutes but a work RVU of 0.96. Finally, we observed that the minimum survey result had a work RVU of 1.10, and we believe this value appropriately reflects the total work for the service. Accordingly, we are proposing 1.10 as the work RVU for CPT code 5039B.

    We employed a similar methodology to develop a proposed work RVU of 4.25 for CPT code 5039C. The three previously established codes are being combined in CPT code 5039C; these had respective work values of 3.37 (CPT code 50392), 0.54 (CPT code 74475), and 0.36 (CPT code 74425); together these sum to 4.27 work RVUs. We also looked at valuing CPT code 5039C based on relativity with other codes in the family. The ratio of the intraservice time of 35 minutes for CPT code 5039A and the intraservice time of 48 minutes for CPT code 5039C; applied to the work RVU of base code 5039A (3.15) results in a potential work RVU of 4.32. The total time compared to CPT code 5039A also went from 91 minutes to 107 minutes and this ratio applied to the base work RVU results in a work RVU of 3.70. We utilized these data to inform our choice of an appropriate crosswalk. We believe CPT code 31660 (Bronchoscopy, rigid or flexible, including fluoroscopic guidance) is an appropriate reference crosswalk for CPT code 5039C. CPT code 31660 has an intraservice time of 50 minutes, total time of 105 minutes, and a work RVU of 4.25. Therefore, we propose to establish the work RVU for CPT code 5039C at the crosswalked value of 4.25 work RVUs.

    According to the RUC recommendations, CPT codes 5039C and 5039D are very similar procedures, with CPT code 5039D making use of a nephroureteral catheter instead of a nephrostomy catheter. The RUC valued the added difficulty of CPT code 5039D at 1.05 work RVUs compared to code CPT code 5039C. We are maintaining the relative difference in work between these two codes by proposing a value of 5.30 for CPT code 5039D. (This is the work RVU of 4.25 for CPT code 5039C plus 1.05 RVUs.) Additionally, we are using CPT code 57155 (Insertion of uterine tandem and/or vaginal ovoids for clinical brachytherapy) as our reference crosswalk. CPT code 57155 has a work RVU of 5.40 and an identical intraservice time of 60 minutes, but it also has fourteen additional minutes of total time, 133 minutes compared to 119 minutes for CPT code 5039D, which supports the difference of 0.10 RVUs. For these reasons, we are proposing the value of CPT code 5039D at 5.30 work RVUs.

    As with the other genitourinary codes, we developed the proposed work value of CPT code 5039M in order to preserve relativity within the family. CPT code 5039M has 15 fewer minutes of intraservice time compared to CPT code 5039D (45 minutes compared to 60 minutes). This is a ratio of 0.75, applied to the based work RVU of CPT code 5039D (5.30) resulted in a potential work RVU of 3.98. CPT code 5039C was another close match within the family, with 3 more minutes of intraservice time compared to 5039M, 48 minutes of intraservice time instead of 45 minutes. This ratio (0.94) applied to the base work RVU of CPT code 5039C (4.25) also resulted in a potential work RVU of 3.98. Based on this information, we identified CPT code 31634 (Bronchoscopy, rigid or flexible, with balloon occlusion) as an appropriate crosswalk, and propose a work RVU of 4.00 for CPT code 5039M. The two codes share an identical intraservice time of 45 minutes, though the latter possesses a lower total time of 90 minutes.

    For CPT code 5039E, we considered how the code and work RVU would fit within the family in comparison to our proposed values for CPT codes 5039A and 5039C. CPT code 5039A serves as the base code for this group; it has 35 minutes of intraservice time in comparison to 20 minutes for CPT code 5039E. This intraservice time ratio of 0.57 resulted in a potential work RVU of 1.80 for CPT code 5039E when applied to the work RVU of CPT code 5039A (3.15). Similarly, CPT code 5039C is the most clinically similar procedure to CPT code 5039E. CPT code 5039C has 48 minutes of intraservice time compared to 20 minutes of intraservice time for CPT code 5039E. This ratio of 0.42 applied to the base work RVU of CPT code 5039C (4.25) results in a potential work RVU of 1.77. We also made use of two crosswalks to help determine a proposed value for CPT code 5039E. CPT code 64416 (Injection, anesthetic agent; brachial plexus) also includes 20 minutes of intraservice time and has a work RVU of 1.81. CPT code 36569 (Insertion of peripherally inserted central venous catheter) has the same intraservice and total time as CPT code 5039E, with a work RVU of 1.82. Accordingly, we are crosswalking the work RVU for CPT code 5039E to CPT code 36569 and proposing a work RVU of 1.82 for CY 2016.

    The remaining three codes all utilize ureteral stents and form their own small subfamily within the larger group of genitourinary catheter procedures. For CPT code 5069G, we are proposing a

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    work RVU of 4.21, which is the 25th percentile result from the survey information. We believe that the 25th percentile provides a more accurate value for CPT code 5069G based on the work involved in the procedure and within the context of other codes in the family. We are also referencing CPT code 31648 (Bronchoscopy, rigid or flexible, with removal of bronchial valve), which shares 45 minutes of intraservice time and has a work RVU of 4.20, as an appropriate crosswalk for CPT code 5069G.

    For CPT code 5069H, we compared its intraservice time to the code within the family that had the most similar duration, CPT code 5039D. This code has 60 minutes of intraservice time compared to 62 minutes for CPT code 5069H. This is a ratio of 1.03 applied to the base work RVU of CPT code 5039D (5.30) resulted in a potential work RVU of 5.48. We also looked to crosswalks with similar numbers, in particular CPT code 50382 (Removal and replacement of internally dwelling ureteral stent). This code has 60 minutes of intraservice time, 125 minutes of total time, and a work RVU of 5.50. For these reasons, we are crosswalking CPT code 5069H to CPT code 50382 and proposing a work RVU of 5.50.

    Finally, we developed the proposed value for CPT code 5069I using three related methods. CPT codes 5069H and 5069I describe very similar procedures, with 5069I adding the use of a nephrostomy tube. The RUC addressed the additional difficulty of this procedure by recommending 1.55 more work RVUs for CPT code 5069I than for CPT code 5069H. Adding the 1.55 work RVUs to the proposed work RVU for CPT code 5069H (5.50) would produce a work RVU of 7.05 for CPT code 5069I. We also looked at the ratio of intraservice times for CPT code 5069I (75 minutes) and the base code in the subfamily, CPT code 5069G (45 minutes). The intraservice time ratio between these two codes is 1.67 when applied to the base work RVU of CPT code 5069G (4.21) resulted in a potential work RVU of 7.02. We also identified an appropriate crosswalk reference in CPT code 36481 (Percutaneous portal vein catheterization by any method) which shares the same intraservice time as CPT code 5069I and has a work RVU of 6.98. Accordingly, to maintain relativity among this subfamily of codes, we are proposing a work RVU of 7.05 for CPT code 5069I based on an incremental increase of 1.55 RVUs from CPT code 5069H.

    In reviewing the direct PE inputs for this family of codes, we refined a series of the RUC- recommended inputs in order to maintain relativity with current standards. All of the following refinements refer to the non-facility setting for this family of codes. Under the clinical labor inputs, we are proposing to remove the RN/LPN/MTA (L037D) (intraservice time for assisting physician in performing procedure) for CPT codes 5039B and 5039E. This amounts to 15 minutes for CPT code 5039B and 20 minutes for CPT code 5039E. Moderate sedation is not inherent in these procedures and, therefore, we do not believe that this clinical labor task would typically be completed in the course of this procedure. We are also reducing the RadTech (L041B) intraservice time for acquiring images from 47 minutes to 46 minutes for CPT code 5069H. This procedure contains 62 minutes of intraservice time, with clinical labor assigned for acquiring images (75 percent) and a circulator (25 percent). The exact time for these clinical labor tasks multiplies out to 46.5 minutes and 15.5 minutes, respectively. The RUC recommendation for CPT code 5069H rounded both of these values upwards, assigning 47 minutes for acquiring images and 16 minutes for the circulator, which together sum to 63 minutes. We are reducing the clinical labor time for acquiring images to 46 minutes to preserve the 62 minutes of total intraservice time for CPT code 5069H.

    During the post-service portion of the clinical labor service period, we are proposing to change the labor type for the ``patient monitoring following service/check tubes, monitors, drains (not related to moderate sedation)'' input. There are 45 minutes of clinical labor time assigned under this category to CPT codes 5039A, 5039C, 5039D, 5039M, 5069G, 5069H, and 5069I. Although we agree that the 45 minutes are appropriate for these procedures as part of moderate sedation, we are changing the clinical labor type from the recommended RN (L051A) to RN/LPN/MTA (L037D) to reflect the staff that will typically be doing the monitoring for these procedures. Even though the CPT Editorial Committee's description of post-service work for CPT code 5039E includes a recovery period for sedation, we recognize that according to the recommendation, CPT codes 5039B and 5039E do not use moderate sedation, so we did not propose to include moderate sedation inputs for these codes.

    The RUC recommendation for CPT code 5039D includes a nephroureteral catheter as a new supply input with an included invoice. However, in the RUC summary of recommendations for this code, there is no mention of a nephroureteral catheter in the intraservice work description. CPT code 5039D does mention the use of a nephroureteral stent in this description, but there is no request for a nephroureteral stent supply item on the PE worksheet for this code. We are therefore seeking clarification from stakeholders regarding the use of the nephroureteral catheter for CPT code 5039D. We have not proposed to add the nephroureteral catheter as a supply item for CPT code 5039D pending this information. We are also requesting a clarification to the intraservice work description in the summary of recommendations for this code to explain the use, if any, of the nephroureteral catheter in this procedure.

    The RUC recommended the inclusion of ``room, angiography'' (EL011) for this family of codes. We do not agree with the RUC that an angiography room would be used in the typical case for these procedures, as there are other rooms available which can provide fluoroscopic guidance. Most of the codes that make use of an angiography room are cardiovascular codes, and much of the equipment listed for this room would not be used for non-cardiovascular procedures. We are therefore proposing to replace equipment item ``room, angiography'' (EL011) with equipment item ``room, radiographic-

    fluoroscopic'' (EL014) for the same number of minutes. We are requesting public comment regarding the typical room type used to furnish the services described by these CPT codes, as well as the more general question of the typical room type used for GU and GI procedures. In the past, the RUC has developed broad recommendations regarding the typical uses of rooms for particular procedures, including the radiographic-fluoroscopy room. We believe that such a recommendation from the RUC concerning all of these codes could be useful in ensuring relativity across the PFS.

    (9) Penile Trauma Repair (CPT Codes 5443A and 5443B)

    CPT created these two new codes because there are no existing codes to capture penile traumatic injury that includes penile fracture, also known as traumatic corporal tear, and complete penile amputation. CPT code 5443A will describe a repair of traumatic corporeal tear(s) while CPT code 5443B will describe a replantation, penis, complete amputation. For CPT code 5443B, we disagree with the RUC recommendation of a work RVU of 24.50. We believe that the 25th

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    percentile work RVU of 22.10 provides a more accurate value based on the work involved in the procedure and within the context of other codes in the same family, since CPT code 5443A was also valued using the 25th percentile. We find further support for this valuation through a crosswalk to CPT code 43334 (Repair, paraesophageal hiatal hernia via thoracotomy, except neonatal) which has an identical intraservice time and a work RVU of 22.12. Therefore we are proposing a work RVU of 22.10 for CPT code 5443B.

    Because CPT codes 5443A and 5443B are typically performed on an emergency basis, we question the appropriateness of the standard 60 minutes of preservice clinical labor in the facility setting, as the typical procedure would not make use of office-based clinical labor. For example, we do not believe that the typical case would require 8 minutes to schedule space in the facility for an emergency procedure, or 20 minutes to obtain consent. We are seeking further public comment on this issue from the RUC and other stakeholders.

    (10) Intrastromal Corneal Ring Implantation (CPT Code 657XG)

    CPT code 657XG is a new code describing insertion of prosthetic ring segments into the corneal stroma for treatment of keratoconus in patients whose disease has progressed to a degree that they no longer tolerate contact lens wear for visual rehabilitation.

    We disagree with the RUC recommendation of a work RVU of 5.93 for CPT code 657XG. Although we appreciated the extensive list of other codes the RUC provided as references, we are concerned that the recommended value for CPT code 657XG overestimates the work involved in furnishing this service relative to other PFS services. We did not find a single code with comparable intraservice and total time that had a higher work RVU. The recommended crosswalk, CPT code 67917 (Repair of ectropion; extensive), appears to have the highest work RVU of any 90-

    day global surgery service in this range of work time values. It also has longer intraservice time and total time than the code in question, making a direct crosswalk inappropriate.

    As a result, we are proposing a new value for CPT code 657XG based on the intraservice time ratio in relation to the recommended crosswalk. We compared the 33 minutes of intraservice time in CPT code 67917 to the 30 minutes of intraservice time in CPT code 657XG. The intraservice time ratio between these two codes is 0.91, and when multiplied by the work RVU of CPT code 67917 (5.93) resulted in a potential work RVU of 5.39. We also considered CPT code 58605 (Ligation or transection of fallopian tube(s)), which has the same intraservice time, seven additional minutes of total time, and a work RVU of 5.28. We believe that CPT 58605 is a closer fit for a direct crosswalk because it shares the same intraservice time of 30 minutes with CPT code 657XG. Accordingly, we are proposing a work RVU of 5.39 for CPT code 657XG.

    The RUC recommendation for CPT code 657XG includes a series of invoices for several new supplies and equipment items. One of these was the 10-0 nylon suture with two submitted invoice prices of $245.62 per box of 12, or $20.47 per suture, and another was priced at $350.62 per box of 12, or $29.22 per suture. Given the range of prices between these two invoices, we sought publicly available information and identified numerous sutures that appear to be consistent with those recommended by the specialty society, at lower prices, which we believe are more likely to be typical since we assume that the typical practitioner would seek the best price. One example is ``Surgical Suture, Black Monofilament, Nylon, Size: 10-0, 12''/30cm, Needle: DSL6, 12/bx'' for $146. Therefore, we are proposing to establish a new supply code for ``suture, nylon 10-0'' and price that item at $12.17 each. We welcome comments from stakeholders regarding this supply item.

    (11) Dilation and Probing of Lacrimal and Nasolacrimal Duct (CPT Codes 66801, 68810, 68811, 68815 and 68816)

    The RUC's review of 10-day global services identified 18 services with greater than 1.5 office visits and 2012 Medicare utilization data over 1,000, including CPT codes 66801, 68810, 68811, 68815, and 68816. As a result, the RUC requested these services be surveyed reviewed for CY 2016.

    The RUC recommended a work RVU of 1.00 for CPT code 68801 and a work RVU of 1.54 for CPT code 68810. While we are proposing to use the RUC-recommended work RVU for CPT code 68810, we do not believe the recommendation for CPT code 68801 best reflects the work involved in the procedure because of a discrepancy between the post-operative work time and work RVU. Specifically, the RUC recommendation for the procedure included the removal of a 99211 visit, but the RUC-

    recommended work RVU did not reflect any corresponding adjustment. As a result, we are proposing to accept the RUC's recommendation to remove the 99211 visit from the service but are proposing to further reduce the work RVU for CPT code 68801 by removing the RVUs associated with CPT code 99211. Therefore, for CY 2016, we are proposing a work RVUs of 0.82 to CPT code 68801 and 1.54 to CPT code 68810.

    The RUC recommended a work RVU of 2.03, 3.00, and 2.35 for CPT codes 68811, 68815 and 68816, respectively. We do not believe the RUC recommendations for these services best reflect the work involved in performing these procedures. To value these services, we calculated a total time ratio by dividing the code's current total time by the RUC-

    recommended total time, and then applying that ratio to the current work RVU. This produces our CY 2016 proposed work RVUs of 1.74, 2.70, and 2.10 for CPT codes 68811, 68815, and 68816, respectively.

    (12) Spinal Instability (CPT Code 7208A, 7208B, 7208C, and 7208D)

    For CY 2015, the CPT Editorial Panel deleted codes 72010 (radiologic examination, spine, entire, survey study, anteroposterior and lateral), 72069 (radiologic examination, spine, thorocolumbar, standing (scoliosis)), and 72090 (radiological examination, spine; scoliosis study, including supine and erect studies), revised one code, 72080 (Radiologic examination, spine; thoracolumbar junction, minimum of 2 views) and created four new codes which cover radiologic examination of the entire thoracic and lumbar spine, including the skull, cervical and sacral spine if performed. The new codes were organized by number of views, ranging from one view in 7208A, two to three views in 7208B, four to five views in 7208C, and minimum of 6 views in 7208D.

    We disagree with the RUC's work RVU recommendations for these four codes. For 7208A, we noted that the one minute increase in time resulted in a larger work RVU than would be expected when taking the ratio between time and RVU in the source code and comparing that to the time and work RVU ratio in the new code. Using the relationship between time and RVU from deleted code 72069, we are proposing a work RVU of 0.26 for 7208A, which differs from the RUC-recommended value of 0.30. Using an incremental methodology based on the relationship between work and time in the first code we are proposing to adjust the RUC-

    recommended work RVUs for CPT codes 7208B, 7208C and 7208D to, respectively, 0.31, 0.35, and 0.41.

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    (13) Echo Guidance for Ova Aspiration (CPT Code 76948)

    In the CY 2014 PFS final rule with comment period, we requested additional information to assist us in the valuation of ultrasound guidance codes. We nominated these codes as potentially misvalued based on the extent to which standalone ultrasound guidance codes were billed separately from services where ultrasound guidance was an integral part of the procedure. CPT code 76948 was among the codes considered potentially misvalued. CPT code 76948 was surveyed by the specialty societies and the RUC issued a recommendation for CY 2016. We have concerns about valuation this code, considering that it is a guidance code used only for a single procedure: 58970 (aspiration of ova), and we believe that these two codes are almost always billed concurrently. We believe codes 76948 and 58970 should be bundled to accurately reflect how the service is furnished.

    We are proposing to use work times based on refinements of the RUC-

    recommended values by removing the 3 minutes of pre and post service time since these times are reflected in the 58970 procedure code. We are proposing work and time values for 76948 based on a crosswalk from 76945 (Ultrasonic guidance for chorionic villus sampling, imaging supervision and interpretation) which has a physician work time of 30 minutes and an RVU of 0.56. Therefore we are proposing to maintain 25 minutes of intraservice time for 76948 and proposing a work RVU of 0.56.

    (14) Immunohistochemistry (CPT Codes 88341, 88342, and 88344)

    In establishing interim final direct PE inputs for CY 2015 for CPT codes 88341, 88342, and 88344, we replaced the RUC-recommended supply item ``UltraView Universal DAB Detection Kit'' (SL488) with ``Universal Detection Kit'' (SA117), since the RUC did not provide an explanation for the required use of a more expensive kit. We also adjusted the equipment time for equipment item ``microscope, compound'' (EP024). We re-examined these codes when valuing the immunofluorescence family of codes for CY 2016, and reviewed information received by commenters that explained the need for these supply items. Specifically, commenters explained that the universal detection kit that CMS included in place of the RUC-recommended kit was not typically used in these services as it was not clinically appropriate. We are proposing to include the RUC-

    recommended supply item, SL488, for CPT codes 88341, 88342, and 88344, as well as the RUC-recommended equipment time for ``microscope, compound'' for CY 2016.

    (15) Immunofluorescent Studies (CPT Codes 88346 and 8835X)

    For CY 2016, the CPT Editorial Panel deleted one code, CPT 88347 (Antibody evaluation), created a new add-on service, CPT 8835X, and revised CPT code 88346 to describe immunofluorescent studies. The RUC recommended a work RVU of 0.74 for CPT code 88346 and 0.70 for CPT code 8835X. While we are accepting the RUC recommendation for CPT code 88346, we do not believe the recommendation for CPT code 8835X best reflects the work involved in the procedure due to our concerns with the relationship between the RUC-recommended intraservice times for the base code and the newly created add-on code. We examined intraservice time relationships between other base codes and add-on codes and found that two codes in the Intravascular ultrasound family, CPT 37250 (Ultrasound evaluation of blood vessel during diagnosis or treatment) and 37251(Ultrasound evaluation of blood vessel during diagnosis or treatment), share a similar base code/add-on code intraservice time relationship, and are also diagnostic in nature, as are CPT codes 88346 and 8835X. Due to these similarities, we believe it is appropriate to apply the relationship, which is a 24 percent difference, between CPT codes 37250 and 37251 in calculating work RVUs for CPT codes 88346 and 8835X. Multiplying the RVU of CPT code 88346, 0.74, by 24 percent, and then subtracted the product from 0.74 results in a work RVU of 0.56 for CPT code 8835X. Therefore, for CY 2016, we are proposing a work RVU of 0.74 for CPT code 88346 and 0.56 for CPT code 8835X.

    (16) Morphometric Analysis (CPT Codes 88364, 88365, 88366, 88367, 88373, 88374, 88377, 88368, and 88369)

    CPT codes 88367 and 88368 were reviewed and valued in the CY 2015 PFS final rule with comment period (79 FR 67668 through 67669). Since then, the RUC has re-reviewed these services for CY 2016 due to the specialty society's initially low survey response rate. In our review of these codes, we noticed that the latest RUC recommendation is identical to the RUC recommendation provided for CY 2015 rulemaking. As a result, we do not believe there is any reason to modify our CY 2015 work RVUs or work time for these procedures. Therefore, we are proposing to retain the CY 2015 work RVUs and work time for CPT codes 88367 and 88368 for CY 2016.

    In establishing interim final direct PE inputs for CY 2015 for CPT codes 88364, 88365, 88366, 88367, 88373, 88374, 88377, 88368, and 88369, we refined the RUC-recommended direct PE inputs as follows. We refined the units of several supply items, including ``ethanol, 100%'' (SL189), ``ethanol, 70%'' (SL190), ``ethanol, 85%'' (SL191), ``ethanol, 95%'' (SL248), ``kit, FISH paraffin pretreatment'' (SL195), ``kit, HER-

    2/neu DNA Probe'' (SL196), positive and negative control slides (SL112, SL118, SL119, SL184, SL185, SL508, SL509, SL510, SL511), ``(EBER) DNA Probe Cocktail'' (SL497),''Kappa probe cocktails'' (SL498) and ``Lambda probe cocktails'' (SL499), to maintain consistency within the codes in the family, and adjusted the quantities included in these codes to align with the code descriptors and better reflect the typical resources used in furnishing these services. We also adjusted the equipment time for equipment items ``water bath, FISH procedures (lab)'' (EP054), ``chamber, Hybridization'' (EP045), ``microscope, compound'' (EP024), ``instrument, microdissection (Veritas)'' (EP087), and ``ThermoBrite'' (EP088), to reflect the typical time the equipment is used, among other common refinements.

    We re-examined these codes when valuing the immunofluorescence family of codes for CY 2016, and reviewed information received from commenters that described the typical batch size for each of these services, thereby explaining the apparent inconsistencies and discrepancies in the quantity of units among the codes in the family. We are proposing to include the RUC-recommended quantities for each of these supply items for the CPT codes 88364, 88365, 88366, 88367, 88373, 88374, 88377, 88368, and 88369 for CY 2016. With regard to the equipment items, we received information explaining that the recommended equipment times already accounted for the typical batch size, and thus, the recommended times were already reflective of the typical case. Therefore, we are proposing to adjust the equipment time for equipment items EP054, EP045, and EP087 to align with the RUC-

    recommended times. We also received comments explaining the need for equipment item EP088. Based on that information, we are proposing to include this equipment item consistent with the RUC recommendations for CPT code 88366.

    We note that the information we received regarding the typical batch size

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    was critical in determining the appropriate direct PE inputs for these pathology services. We also note that we usually do not have information regarding the typical batch size or block size when we are reviewing the direct PE inputs for pathology services. The supply quantity and equipment minutes are often a direct function of the number of tests processed at once. Given the importance of the typical number of tests being processed by a laboratory in determining the direct PE inputs, which often include expensive supplies, we are very concerned that the direct PE inputs included in many pathology services may not reflect the typical resource costs involved in furnishing the typical service.

    In particular, we note that since laboratories of various sizes furnish pathology tests and that, depending on the test, a large laboratory may be at least as likely to have furnished a test to a Medicare beneficiary compared to a small laboratory, we believe that an equipment item included in a recommendation that is commercially available to a small laboratory may not be the same equipment item that is used in the typical case. If the majority of services billed under the PFS for a particular CPT code are furnished by laboratories that run many of these tests each day, then assumptions informed by commercially available products may significantly underestimate the typical number of tests processed together, and thus the assumptions underlying current valuations for per-test cost of supplies and equipment may be much higher than the typical resources used in furnishing the service. We invite stakeholders to provide us with information about the equipment and supply inputs used in the typical case for particular pathology services.

    (17) Vestibular Caloric Irrigation (CPT Codes 9254A and 9254B)

    For CY 2016, the CPT Editorial Panel deleted CPT code 92543 (Assessment and recording of balance system during irrigation of both ears) and created two new CPT codes, 9254A and 9254B, to report caloric vestibular testing for bithermal and monothermal testing procedures, respectively. The RUC recommended a work RVU of 0.80 for CPT code 9254A and a work RVU of 0.55 for CPT code 9254B. We believe the recommendations for these services overstate the work involved in performing these procedures. Due to similarity in service and time, we believe a direct crosswalk of CPT code 97606 (Negative pressure wound therapy, surface area greater than 50 square centimeters, per session) to CPT code 9254A is appropriate. To value CPT code 9254B, we divided the proposed work RVU for 9254A in half since the code descriptor for this procedure describes the service as having two irrigations as opposed to the four involved in 9254A. Therefore, for CY 2016, we are proposing a work RVUs of 0.60 to 9254A and 0.30 to 9254B.

    (18) Instrument-Based Ocular Screening (CPT Codes 99174 and 9917X)

    For CY 2015, the CPT Editorial Panel created a new code, CPT code 9917X, to describe instrument-based ocular screening with on-site analysis and also revised existing CPT code 99174, which describes instrument-based ocular screening with remote analysis and report. Currently, CPT code 99174 is assigned a status indicator of N (non-

    covered service) which we believe should be maintained due to its nature as a screening service. After review of CPT code 9917X, we believe this service is also a screening service and should be assigned a status indicator of N (non-covered service). Therefore, for CY 2016, we are proposing to assign a PFS status indicator of N (non-covered service) for CPT codes 99174 and 9917X.

    (19) Low-Dose Computer Tomography, Lung, Screening (GXXX1) and Lung Cancer Screening Counseling and Shared Decision Making Visit (GXXX2)

    We have issued national coverage determination (NCD) for the coverage of a lung cancer screening counseling and shared decision making visit and, for appropriate beneficiaries, annual screening with low dose computed tomography (LDCT) as an additional preventive benefit. The American College of Radiology (ACR) submitted recommendations for work and direct PE inputs. The ACR recommended that we crosswalk GXXX1 to 71250 (computed tomography, thorax; without contrast material) with additional physician work added to account for the added intensity of the service. After reviewing this recommendation, we believe that the physician work (time and intensity) is identical in both GXXX1 and 71250, and therefore, we are proposing a work RVU of 1.02 for GXXX1.

    We are proposing to value the lung cancer screening counseling and shared decision making visit (GXXX2) using a crosswalk from the work value for G0443 (Brief face-to-face counseling for alcohol misuse, 15 minutes) which has a work RVU of 0.45. We added 2 minutes of pre-

    service time, and 1 minute post-service time which we valued at 0.0224 RVU per minute yielding a total of 0.062 additional RVUs which we then added to 0.45, bringing the total proposed work RVUs for GXXX2 to 0.52. The direct PE input recommendations from the ACR were refined according to CMS standard refinements and appear in the CY 2016 proposed direct PE input database.

    7. Direct PE Input-Only Recommendations

    In CY 2014, we proposed to limit the nonfacility PE RVUs for individual codes so that the total nonfacility PFS payment amount would not exceed the total combined amount that Medicare would pay for the same code in the facility setting. In developing the proposal, we sought a reliable means for Medicare to set upper payment limits for office-based procedures given our several longstanding concerns regarding the accuracy of certain aspects of the direct PE inputs, including both items and procedure time assumptions, and prices of individual supplies and equipment (78 FR 74248 through 74250). After considering the many comments we received regarding our proposal, the majority of which urged us to withdraw the proposal for a variety of reasons, we decided not to finalize the policy. However, we continue to believe that using practice expense data that are auditable, comprehensive, and regularly updated would contribute to the accuracy of practice expense calculations.

    Subsequent to our decision not to finalize the proposal, the RUC forwarded direct PE input recommendations for a subset of codes with nonfacility PE RVUs that would have been limited by the policy. Some of these codes also include work values, but the RUC recommendations did not address the accuracy of those values.

    We generally believe that combined reviews of work and PE for each code under the potentially misvalued codes initiative leads to more accurate and appropriate assignment of RVUs. We also believe, and have previously stated, that our standard process for evaluating potentially misvalued codes is unlikely to be the most effective means of addressing our concerns regarding the accuracy of some aspects of the direct PE inputs (79 FR 74248).

    However, we also believe it is important to use the most accurate and up-to-date information available to us when developing PFS RVUs for individual services. Therefore, we have reviewed the RUC-recommended direct PE inputs for these services and are proposing to use them, with the refinements addressed in this section. However, we are also identifying these

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    codes as potentially misvalued because their direct PE inputs were not reviewed alongside review of their work RVUs and time. We considered not addressing these recommendations until such time as comprehensive reviews could occur, but we recognized the public interest in using the updated recommendations regarding the PE inputs until such time as the work RVUs and time can be addressed. Therefore, we note that while we are proposing adjusted PE inputs for these services based on these recommendations, we would anticipate addressing any corresponding change to direct PE inputs once the work RVUs and time are addressed.

    a. Repair of Nail Bed (CPT Code 11760)

    This recommendation includes 22 minutes of clinical labor time assigned for ``Assist physician in performing procedure.'' Because CPT code 11760 has 33 minutes of work intraservice time, we believe that this clinical labor input was intended to be calculated at 67 percent of work time. However, the equipment times are also calculated based on the 22 minutes of intraservice time. We are seeking comment on whether or not it would be appropriate to include the full 33 minutes of work intraservice time for the equipment.

    b. Submucosal Ablation of the Tongue Base (CPT Code 41530)

    We did not review CPT code 41530 for direct PE inputs, because we noted that the RUC anticipates making recommendations regarding the work RVU and direct PE inputs for this service in the near future.

    c. Cytopathology Fluids, Washings or Brushings (CPT Codes 88104, 88106, 88108)

    We are proposing to update the Millipore filter supply (SL502) based on stakeholder submission of new information following the RUC's original recommendation. As requested, we are proposing to crosswalk the price of the Millipore filter to the cytology specimen filter (Transcyst) supply (SL041) and assign a value of $4.15. This change is reflected in the proposed direct PE input database.

    d. Cytopathology Smears, Screening and Interpretation (CPT Codes 88160, 88161, 88162)

    We are concerned that there is a lack of clarity and the possibility for confusion contained in the CPT descriptors of CPT codes 88160 and 88161. The CPT descriptor for the first code refers to the ``screening and interpretation'' of Cytopathology smears, while the descriptor for the second code refers to the ``preparation, screening and interpretation'' of Cytopathology smears. We believe that there is currently the potential for duplicative counting of direct PE inputs due to the overlapping nature of these two codes. We are concerned that the same procedure may be billed multiple times under both CPT code 88160 and 88161. We believe that these codes are potentially misvalued, and we are seeking a full review of this family of codes for both work and PE, given the potential for overlap. We recognize that the ideal solution may involve revisions by the CPT Editorial Panel.

    With regard to the current direct PE input recommendations, we are proposing to remove the clinical labor minutes recommended for ``Stain air dried slides with modified Wright stain'' for CPT code 88160 since staining slides would not be a typical clinical labor task if there is no slide preparation taking place, as the descriptor for this code suggests.

    We are proposing to update the protease solution supply (SL506) based on stakeholder submission of new information following the RUC's original recommendation. As requested, we are proposing to change the name of the supply to ``Protease'', alter the unit of measurement from milliliters to milligrams, change the quantity assigned to CPT code 88182 from 1 to 1.12, and update the price from $0.47 to $0.4267. These changes are reflected in the proposed direct PE input database.

    We are requesting additional information regarding the use of the desktop computer with monitor (ED021) for CPT code 88182. We have made no change to the current equipment time value pending the submission of additional information.

    e. Flow Cytometry, Cytoplasmic Cell Surface (CPT Code 88184, 88185)

    We are requesting additional information regarding the specific use of the desktop computer with monitor (ED021) for CPT codes 88184 and 88185 since the recommendation does not specify how it is used.

    f. Consultation on Referred Slides and Materials (CPT Codes 88321, 88323, 88325)

    We are proposing to remove the clinical labor time for ``Accession specimen/prepare for examination'' for CPT codes 88321 and 88325. These codes do not involve the preparation of slides, so this clinical labor task is duplicative with the labor carried out under ``Open shipping package, remove and sort slides based on outside number.'' We are proposing to maintain the recommended 4 minutes for this clinical labor task for CPT code 88323, since it does require slide preparation.

    We are proposing to refine the clinical labor time for ``Register the patient in the information system, including all demographic and billing information'' from 13 minutes to 5 minutes for all three codes. As indicated in Table 6, our proposed standard clinical labor time for entering patient data is 4 minutes for pathology codes, and we believe that the extra tasks involving label preparation described in this clinical labor task would typically require an additional 1 minute to complete. We also believe that the additional recommended time likely reflects administrative tasks that are appropriately accounted for in the indirect PE methodology.

    We are proposing to refine the clinical labor time from 7 minutes to 5 minutes for the new task ``Receive phone call from referring laboratory/facility with scheduled procedure to arrange special delivery of specimen procurement kit, including muscle biopsy clamp as needed. Review with sender instructions for preservation of specimen integrity and return arrangements. Contact courier and arrange delivery to referring laboratory/facility.'' Based on the description of this task, we believe that this task would typically take 5 minutes to be performed by the Lab Technician.

    We are proposing to remove the eosin solution supply (SL063) from CPT code 88323. We do not agree that this supply would be typically used in this procedure, and the eosin solution is redundant when used together with the hematoxylin stain supply (SL135). We are also refining the quantity of the hematoxylin stain from 32 to 8 for CPT code 88323, to be consistent with its use in other related Pathology codes.

    We are proposing to remove many of the inputs for clinical labor, supplies, and equipment for CPT code 88325. The descriptor for this code indicates that it does not involve slide preparation, and therefore we are proposing labor, supplies, and equipment inputs to match the inputs recommended for CPT code 88321, which also does not include the preparation of slides.

    g. Morphometric Analysis, Tumor Immunohistochemistry (CPT Codes 88360, 88361)

    We are proposing to update the pricing for the Benchmark ULTRA automated slide preparation system (EP112) and the E-Bar II Barcode Slide Label System (EP113). Based on stakeholder submission of information subsequent to the original RUC recommendation, we are reclassifying

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    these two pieces of equipment as a single item with a price of $150,000. CPT codes 88360 and 88361 have been valued using this new price. The equipment time values remain unchanged.

    The RUC recommendation for CPT codes 88360 and 88361 included an invoice for the Antibody Estrogen Receptor monoclonal supply (SL493). The submitted invoice has a price of $694.70 per box of 50, or $13.89 per test. We sought publically available information regarding this supply and identified numerous monoclonal antibody estrogen receptors that appear to be consistent with those recommended by the specialty society, at publicly available lower prices, which we believe are more likely to be typical since we assume that the typical practitioner would seek the best price available to the public. One example is Estrogen Receptor Antibody (h-151) DyLight 405, priced at 100 tests per box for $319. Therefore, we are proposing to establish a new supply code for ``Antibody Estrogen Receptor monoclonal'' and price that item at $3.19 each. We welcome comments from stakeholders regarding this supply item.

    h. Nerve Teasing Preparations (CPT Code 88362)

    We are proposing to refine the recommended clinical labor time for ``Assist pathologist with gross specimen examination including the following; Selection of fresh unfixed tissue sample; selection of tissue for formulant fixation for paraffin blocking and epon blocking. Reserve some specimen for additional analysis'' from 10 minutes to 5 minutes. We note that the 5 minutes includes 3 minutes for assisting the pathologist with the gross specimen examination (as listed in Table 6) and an additional 2 minutes for the additional tasks due to the work taking place on a fresh specimen.

    i. Nasopharyngoscopy With Endoscope (CPT Code 92511)

    We are proposing to remove the endosheath (SD070) from this procedure, because we do not believe it would be typically used and it was not included in the recommendations for any of the other related codes in the same tab. If the endosheath were included as a supply with the presentation of additional clinical information, then we believe it would be appropriate to remove all of the clinical labor and equipment time currently assigned to cleaning the scope.

    j. Needle Electromyography (CPT Codes 95863, 95864, 95869, 95870)

    We are proposing to reduce the quantity of the iontophoresis electrode kit (SA014) supply from 4 to 3. According to the description of this code, the procedure typically uses 2-4 electrodes, and therefore we believe that a supply quantity of 3 would better reflect the typical case. We are requesting further information regarding the typical number of electrodes used in this procedure; if the maximum of 4 electrodes is in fact typical for the procedure, then we recommend that the code descriptor be referred to CPT for further clarification.

  37. Medicare Telehealth Services

    1. Billing and Payment for Telehealth Services

    Several conditions must be met for Medicare to make payments for telehealth services under the PFS. The service must be on the list of Medicare telehealth services and meet all of the following additional requirements:

    The service must be furnished via an interactive telecommunications system.

    The service must be furnished by a physician or authorized practitioner.

    The service must be furnished to an eligible telehealth individual.

    The individual receiving the service must be located in a telehealth originating site.

    When all of these conditions are met, Medicare pays a facility fee to the originating site and makes a separate payment to the distant site practitioner furnishing the service.

    Section 1834(m)(4)(F)(i) of the Act defines Medicare telehealth services to include consultations, office visits, office psychiatry services, and any additional service specified by the Secretary, when furnished via a telecommunications system. We first implemented this statutory provision, which was effective October 1, 2001, in the CY 2002 PFS final rule with comment period (66 FR 55246). We established a process for annual updates to the list of Medicare telehealth services as required by section 1834(m)(4)(F)(ii) of the Act in the CY 2003 PFS final rule with comment period (67 FR 79988).

    As specified at Sec. 410.78(b), we generally require that a telehealth service be furnished via an interactive telecommunications system. Under Sec. 410.78(a)(3), an interactive telecommunications system is defined as multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician or practitioner.

    Telephones, facsimile machines, and stand-alone electronic mail systems that are not integrated into an electronic health record system do not meet the definition of an interactive telecommunications system. An interactive telecommunications system is generally required as a condition of payment; however, section 1834(m)(1) of the Act allows the use of asynchronous ``store-and-forward'' technology when the originating site is part of a federal telemedicine demonstration program in Alaska or Hawaii. As specified in Sec. 410.78(a)(1), asynchronous store-and-forward is the transmission of medical information from an originating site for review by the distant site physician or practitioner at a later time.

    Medicare telehealth services may be furnished to an eligible telehealth individual notwithstanding the fact that the practitioner furnishing the telehealth service is not at the same location as the beneficiary. An eligible telehealth individual is an individual enrolled under Part B who receives a telehealth service furnished at an originating site.

    Practitioners furnishing Medicare telehealth services are reminded that these services are subject to the same non-discrimination laws as other services, including the effective communication requirements for persons with disabilities of section 504 of the Rehabilitation Act and language access for persons with limited English proficiency, as required under Title VI of the Civil Rights Act of 1964. For more information, see http://www.hhs.gov/ocr/civilrights/resources/specialtopics/hospitalcommunication.

    Practitioners furnishing Medicare telehealth services submit claims for telehealth services to the Medicare Administrative Contractors that process claims for the service area where their distant site is located. Section 1834(m)(2)(A) of the Act requires that a practitioner who furnishes a telehealth service to an eligible telehealth individual be paid an amount equal to the amount that the practitioner would have been paid if the service had been furnished without the use of a telecommunications system.

    Originating sites, which can be one of several types of sites specified in the statute where an eligible telehealth individual is located at the time the service is being furnished via a telecommunications system, are paid a fee under the PFS a facility fee for each Medicare telehealth service. The statute

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    specifies both the types of entities that can serve as originating sites and the geographic qualifications for originating sites. With regard to geographic qualifications, Sec. 410.78(b)(4) limits originating sites to those located in rural health professional shortage areas (HPSAs) or in a county that is not included in a metropolitan statistical areas (MSAs).

    Historically, we have defined rural HPSAs to be those located outside of MSAs. Effective January 1, 2014, we modified the regulations regarding originating sites to define rural HPSAs as those located in rural census tracts as determined by the Office of Rural Health Policy (ORHP) of the Health Resources and Services Administration (HRSA) (78 FR 74811). Defining ``rural'' to include geographic areas located in rural census tracts within MSAs allows for broader inclusion of sites within HPSAs as telehealth originating sites. Adopting the more precise definition of ``rural'' for this purpose expands access to health care services for Medicare beneficiaries located in rural areas. HRSA has developed a Web site tool to provide assistance to potential originating sites to determine their geographic status. To access this tool, see the CMS Web site at www.cms.gov/teleheath/.

    An entity participating in a federal telemedicine demonstration project that has been approved by, or received funding from, the Secretary as of December 31, 2000 is eligible to be an originating site regardless of its geographic location.

    Effective January 1, 2014, we also changed our policy so that geographic status for an originating site would be established and maintained on an annual basis, consistent with other telehealth payment policies (78 FR 74400). Geographic status for Medicare telehealth originating sites for each calendar year is now based upon the status of the area as of December 31 of the prior calendar year.

    For a detailed history of telehealth payment policy, see 78 FR 74399.

    2. Adding Services to the List of Medicare Telehealth Services

    As noted previously, 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 with an ongoing opportunity to submit requests for adding services. Under this process, we assign any qualifying request to make additions to the list of telehealth services to one of two categories. Revisions to criteria that we use to review requests in the second category were finalized in the November 28, 2011 Federal Register (76 FR 73102). The two categories are:

    Category 1: Services that are similar to professional consultations, office visits, and office psychiatry services that are currently on the list of telehealth services. In reviewing these requests, we look for similarities between the requested and existing telehealth services for the roles of, and interactions among, the beneficiary, the physician (or other practitioner) at the distant site and, if necessary, the telepresenter, a practitioner who is present with the beneficiary in the originating site. 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 service is accurately described by the corresponding code when furnished via telehealth and whether the use of a telecommunications system to deliver the service produces demonstrated clinical benefit to the patient. In reviewing these requests, we look for evidence indicating that the use of a telecommunications system in furnishing the candidate telehealth service produces clinical benefit to the patient. Submitted evidence should include both a description of relevant clinical studies that demonstrate the service furnished by telehealth to a Medicare beneficiary improves the diagnosis or treatment of an illness or injury or improves the functioning of a malformed body part, including dates and findings, and a list and copies of published peer reviewed articles relevant to the service when furnished via telehealth. Our evidentiary standard of clinical benefit does not include minor or incidental benefits.

    Some examples of clinical benefit include the following:

    Ability to diagnose a medical condition in a patient population without access to clinically appropriate in-person diagnostic services.

    Treatment option for a patient population without access to clinically appropriate in-person treatment options.

    Reduced rate of complications.

    Decreased rate of subsequent diagnostic or therapeutic interventions (for example, due to reduced rate of recurrence of the disease process).

    Decreased number of future hospitalizations or physician visits.

    More rapid beneficial resolution of the disease process treatment.

    Decreased pain, bleeding, or other quantifiable symptom.

    Reduced recovery time.

    For the list of covered telehealth services, see the CMS Web site at www.cms.gov/teleheath/. 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, qualifying requests submitted before the end of CY 2015 will be considered for the CY 2017 proposed rule. Each request to add a service to the list of Medicare telehealth services must include any supporting documentation the requester wishes us to consider as we review the request. Because we use the annual PFS rulemaking process as a vehicle for making changes to the list of Medicare telehealth services, requestors should be advised that any information submitted is subject to public disclosure for this purpose. For more information on submitting a request for an addition to the list of Medicare telehealth services, including where to mail these requests, see the CMS Web site at www.cms.gov/telehealth/.

    3. Submitted Requests to the List of Telehealth Services for CY 2016

    Under our existing policy, we add services to the telehealth list on a category 1 basis when we determine that they are similar to services on the existing telehealth list with respect to the roles of, and interactions among, the beneficiary, physician (or other practitioner) at the distant site and, if necessary, the telepresenter. As we stated in the CY 2012 final rule with comment period (76 FR 73098), we believe that the category 1 criteria not only streamline our review process for publicly requested services that fall into this category, the criteria also expedite our ability to identify codes for the telehealth list that resemble those services already on this list.

    a. Submitted Requests

    We received several requests in CY 2014 to add various services as Medicare telehealth services effective for CY 2016. The following presents a discussion of these requests, and our proposals for additions to the CY 2016 telehealth list. Of the requests received, we find that the following services are sufficiently similar to psychiatric diagnostic procedures or office/outpatient visits currently on the telehealth list to qualify on a category one basis. Therefore, we propose to add the following services to the telehealth list on a category 1 basis for CY 2016:

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    CPT code 99356 (prolonged service in the inpatient or observation setting, requiring unit/floor time beyond the usual service; first hour (list separately in addition to code for inpatient evaluation and management service); and 99357 (prolonged service in the inpatient or observation setting, requiring unit/floor time beyond the usual service; each additional 30 minutes (list separately in addition to code for prolonged service).

    The prolonged service codes can only be billed in conjunction with hospital inpatient and skilled nursing facility evaluation & management (E/M) codes, and of these, only subsequent hospital and subsequent nursing facility visit codes are on list of Medicare telehealth services. Therefore, CPT codes 99356 and 99357 would only be reportable with codes for which limits of one subsequent hospital visit every three days via telehealth, and one subsequent nursing facility visit every thirty days, would continue to apply.

    CPT codes 90963 (end-stage renal disease (ESRD) related services for home dialysis per full month, for patients younger than 2 years of age to include monitoring for the adequacy of nutrition, assessment of growth and development, and counseling of parents); 90964 (end-stage renal disease (ESRD) related services for home dialysis per full month, for patients 2-11 years of age to include monitoring for the adequacy of nutrition, assessment of growth and development, and counseling of parents); 90965 (end-stage renal disease (ESRD) related services for home dialysis per full month, for patients 12-19 years of age to include monitoring for the adequacy of nutrition, assessment of growth and development, and counseling of parents); and 90966 (end-

    stage renal disease (ESRD) related services for home dialysis per full month, for patients 20 years of age and older).

    Although these services are for home-based dialysis, and a patient's home is not an authorized originating site for telehealth, we recognize that many components of these services would be furnished from an authorized originating site and, therefore, can be furnished via telehealth.

    The required clinical examination of the catheter access site must be furnished face-to-face ``hands on'' (without the use of an interactive telecommunications system) by a physician, certified nurse specialist (CNS), nurse practitioner (NP), or physician's assistant (PA). An interactive telecommunications system may be used for providing additional visits required under the 2 to 3 visit Monthly Capitation Payment (MCP) code and the 4 or more visit MCP code. See the final rule for CY 2005 (69 FR 66276) for further information on furnishing ESRD services via telehealth.

    We also received requests to add services to the telehealth list that do not meet our criteria for Medicare telehealth services. We are not proposing to add the following procedures for the reasons noted:

    All evaluation and management services, telerehabilitation services, and palliative care, pain management and patient navigation services for cancer patients.

    None of these requests identified the specific codes that were being requested for addition as telehealth services, and two of the requests did not include evidence of any clinical benefit when the services are furnished via telehealth. Since we did not have information on the specific codes requested for addition or evidence of clinical benefit for these requests, we cannot evaluate whether the services are appropriate for addition to the Medicare telehealth services list.

    CPT codes 99291 (critical care, evaluation and management of the critically ill or critically injured patient; first 30-74 minutes); and 99292 (critical care, evaluation and management of the critically ill or critically injured patient; each additional 30 minutes (list separately in addition to code for primary service).

    We previously considered and rejected adding these codes to the list of Medicare telehealth services in the CY 2009 PFS final rule (74 FR 69744) on a category 1 basis because, due to the acuity of critically ill patients, we did not consider critical care services similar to any services on the current list of Medicare telehealth services. In that rule, we said that critical care services must be evaluated as category 2 services. Because we would consider critical care services under 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.

    The American Telemedicine Association (ATA) submitted a request, which cited several studies to support adding these services on a category 2 basis. To qualify under category 2, we would need evidence that the service produces a clinical benefit for the patient. However, in reviewing the information provided by the ATA and a study entitled, ``Impact of an Intensive Care Unit Telemedicine Program on Patient Outcomes in an Integrated Health Care System,'' published July 2014, in ``JAMA Internal Medicine,'' which found no evidence that the implementation of ICU TM significantly reduced mortality rates or hospital length of stay, we do not believe that the evidence demonstrates a clinical benefit to patients. Therefore, we are not proposing to add these services on a category 2 basis to the list of Medicare telehealth services for CY 2016.

    CPT code 99358 (prolonged evaluation and management service before and/or after direct patient care; first hour) and 99359 (prolonged evaluation and management service before and/or after direct patient care; each additional 30 minutes (list separately in addition to code for prolonged service).

    As we indicated in the CY 2015 PFS final rule with comment period (79 FR 67600), these services are not separately payable by Medicare. It would be inappropriate to include a service as a telehealth service when Medicare does not otherwise make a separate payment for it. Therefore, we are not proposing to add these non-payable services to the list of Medicare telehealth services for CY 2016.

    CPT code 99444 (online evaluation and management service provided by a physician or other qualified health care professional who may report an evaluation and management services provided to an established patient or guardian, not originating from a related E/M service provided within the previous 7 days, using the internet or similar electronic communications network).

    As we indicated in the CY 2014 PFS final rule with comment period (78 FR 74403), we assigned a status indicator of ``N'' (Noncovered service) to this service because: (1) this service is non-face-to-face; and (2) the code descriptor includes language that recognizes the provision of services to parties other than the beneficiary and for whom Medicare does not provide coverage (for example, a guardian). Under section 1834(m)(2)(A) of the Act, Medicare pays the physician or practitioner furnishing a telehealth service an amount equal to the amount that would have been paid if the service was furnished without the use of a telecommunications system. Because CPT code 99444 is currently noncovered, there would be no Medicare payment if this service was furnished without the use of a telecommunications system. Since this service is noncovered under Medicare, we are not proposing to add it to the list of Medicare telehealth services for CY 2016.

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    CPT code 99490 (chronic care management services, at least 20 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month, with the following required elements: multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient; chronic conditions place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline; comprehensive care plan established, implemented, revised, or monitored).

    This service is one that can be furnished without the beneficiary's face-to-face presence, and using any number of non-face-to-face means of communication. Therefore, the service is not appropriate for consideration as a Medicare telehealth service. It is unnecessary to add this service to the list of Medicare telehealth services. Therefore, we are not proposing to add it to the list of Medicare telehealth services for CY 2016.

    CPT codes 99605 (medication therapy management service(s) provided by a pharmacist, individual, face-to-face with patient, with assessment and intervention if provided; initial 15 minutes, new patient); 99606 (medication therapy management service(s) provided by a pharmacist, individual, face-to-face with patient, with assessment and intervention if provided; initial 15 minutes, established patient); and 99607 (medication therapy management service(s) provided by a pharmacist, individual, face-to-face with patient, with assessment and intervention if provided; each additional 15 minutes (list separately in addition to code for primary service).

    These codes are noncovered services for which no payment may be made under the PFS. Therefore, we are not proposing to add these services to the list of Medicare telehealth services for CY 2016.

    In summary, we are proposing to add the following codes to the list of Medicare telehealth services beginning in CY 2016 on a category 1 basis: Prolonged service inpatient CPT codes 99356 and 99357 and ESRD-

    related services 90933 through 90936. As indicated above, the prolonged service codes can only be billed in conjunction with subsequent hospital and subsequent nursing facility codes. Limits of one subsequent hospital visit every three days, and one subsequent nursing facility visit every thirty days, would continue to apply when the services are furnished as telehealth services. For the ESRD related services, the required clinical examination of the catheter access site must be furnished face-to-face ``hands on'' (without the use of an interactive telecommunications system) by a physician, certified nurse specialist (CNS), nurse practitioner (NP), or physician's assistant (PA).

    We remind all interested stakeholders that we are currently soliciting public requests to add services to the list of Medicare telehealth services. To be considered during PFS rulemaking for CY 2017, these requests must be submitted and received by December 31, 2015. Each request to add a service to the list of Medicare telehealth services must include any supporting documentation the requester 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 mail these requests, we refer readers to the CMS Web site at www.cms.gov/telehealth/.

    4. Proposal To Amend Sec. 410.78 To Include Certified Registered Nurse Anesthetists as Practitioners for Telehealth Services

    Under section 1834(m)(1) of the Act, Medicare makes payment for telehealth services furnished by physicians and practitioners. Section 1834(m)(4)(E) of the Act specifies that, for purposes of furnishing Medicare telehealth services, the term ``practitioner'' has the meaning given that term in section 1842(b)(18)(C), which includes a certified registered nurse anesthetist (CRNA) as defined in section 1861 (bb)(2).

    We initially omitted CRNAs from the list of distant site practitioners for telehealth services in the regulation because we did not believe these practitioners would furnish any of the service on the list of Medicare telehealth services. However, CRNAs in some states are licensed to furnish certain services on the telehealth list, including E/M services. Therefore, we propose to revise the regulation at Sec. 410.78(b)(2) to include a CRNA, as described under Sec. 410.69, to the list of distant site practitioners who can furnish Medicare telehealth services.

  38. Incident to Proposals: Billing Physician as the Supervising Physician and Ancillary Personnel Requirements

    1. Background

    Section 1861(s)(2)(A) of the Act establishes the benefit category for services and supplies furnished as ``incident to'' the professional services of a physician. The statute specifies that services and supplies furnished as an incident to a physician's professional service (hereinafter ``incident to services'') are ``of kinds which are commonly furnished in physicians' offices and are commonly either rendered without charge or included in physicians' bills.'' In addition to the requirements of the statute, Sec. 410.26 sets forth specific requirements that must be met for physicians and other practitioners to bill Medicare for incident to services. Section 410.26(a)(7) limits incident to services to those included under section 1861(s)(2)(A) of the Act and that are not covered under another benefit category. Section 410.26(b) specifies (in part) that in order for services and supplies to be paid as incident to services under Medicare Part B, the services or supplies must be:

    Furnished in a noninstitutional setting to noninstitutional patients.

    An integral, though incidental, part of the service of a physician (or other practitioner) in the course of diagnosis or treatment of an injury or illness.

    Furnished under direct supervision (as specified under Sec. 410.26(a)(2)) of a physician or other practitioner eligible to bill and directly receive Medicare payment.

    Furnished by a physician, a practitioner with an incident to benefit, or auxiliary personnel.

    In addition to Sec. 410.26, there are regulations specific to each type of practitioner who is allowed to bill for incident to services as specified in Sec. 410.71(a)(2) (clinical psychologist services), Sec. 410.74(b) (physician assistants' services), Sec. 410.75(d) (nurse practitioners' services), Sec. 410.76(d) (clinical nurse specialists' services), and Sec. 410.77(c) (certified nurse-midwives' services). When referring to practitioners who can bill for services furnished incident to their professional services, we are referring to physicians and these practitioners.

    Incident to services are treated as if they were furnished by the billing physician or other practitioner for purposes of Medicare billing and payment. Consistent with this terminology, in this discussion when referring to the physician or other practitioner furnishing the service, we are referring to the physician or other practitioner who is billing for the incident to service. When we refer to the ``auxiliary personnel'' or the person who provides the service, we are referring to an individual who is personally performing the service or some aspect of it as distinguished from the physician or other practitioner who bills for the incident to service.

    Since we treat incident to services as services furnished by the billing physician or other practitioner for

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    purposes of Medicare billing and payment, payment is made to the billing physician or other practitioner under the PFS, and all relevant Medicare rules apply including, but not limited to, requirements regarding medical necessity, documentation, and billing. Those practitioners who can bill Medicare for incident to services are paid at their applicable Medicare payment rate as if they personally furnished the service. For example, when incident to services are billed by a physician, they are paid at 100 percent of the fee schedule amount, and when the services are billed by a nurse practitioner or clinical nurse specialist, they are paid at 85 percent of the fee schedule amount. Payments are subject to the usual deductible and coinsurance amounts.

    In the CY 2014 PFS final rule with comment period, we amended Sec. 410.26 by adding a paragraph (b)(7) to require that, as a condition for Medicare Part B payment, all incident to services must be furnished in accordance with applicable state law. Additionally, we amended the definition of auxiliary personnel at Sec. 410.26(a)(1) to require that the individual who provides the incident to services must meet any applicable requirements to provide such services (including licensure) imposed by the state in which the services are furnished. These requirements for compliance with applicable state laws apply to any individual providing incident to services as a means to protect the health and safety of Medicare beneficiaries in the delivery of health care services, and to provide the Medicare program with additional recourse for denying or recovering Part B payment for incident to services that are not furnished in compliance with state law (78 FR 74410). Revisions to Sec. 410.26(a)(1) and (b)(7) were intended to clarify the longstanding payment policy of paying only for services that are furnished in compliance with any applicable state or federal requirements. The amended regulations also provide the Medicare program with additional recourse for denying or recovering Part B payment for incident to services that are not furnished in compliance with applicable requirements.

    2. Billing Physician as the Supervising Physician

    In addition to the CY 2014 revisions to the regulations for incident to services, we believe that additional requirements for incident to services should be explicitly and unambiguously stated in the regulations. As described in this proposed rule, incident to a physician's or other practitioner's professional services means that the services or supplies are furnished as an integral, although incidental, part of the physician's or other practitioner's personal professional services in the course of diagnosis or treatment of an injury or illness (Sec. 410.26(b)(2)). Incident to services require direct supervision of the auxiliary personnel providing the service by the physician or other practitioner (Sec. 410.26(b)(5)).

    We are proposing to revise the regulations specifying the requirements for which physicians or other practitioners can bill for incident to services. In the CY 2002 PFS final rule, in response to a comment seeking clarification regarding what physician billing number should be used on the claim form for an incident to service, at 66 FR 55267, we stated that when a claim is submitted to Medicare under the billing number of a physician or other practitioner for an `incident to' service, the physician or other practitioner is stating that he or she performed the service or directly supervised the auxiliary personnel performing the service. Accordingly, the Medicare billing number of the ordering physician or other practitioner should not be used if that person did not directly supervise the auxiliary personnel.

    Section 410.26(b)(5) currently states that the physician (or other practitioner) supervising the auxiliary personnel need not be the same physician (or other practitioner) upon whose professional service the incident to service is based. To be certain that the incident to services furnished to a beneficiary are in fact an integral, although incidental, part of the physician's or other practitioner's personal professional service that is billed to Medicare, we believe that the physician or other practitioner who bills for the incident to service must also be the physician or other practitioner who directly supervises the service. It has been our position that billing practitioners should have a personal role in, and responsibility for, furnishing services for which they are billing and receiving payment as an incident to their own professional services. This is consistent with the requirements that all physicians and billing practitioners attest on each Medicare claim that he or she ``personally furnished'' the services for which he or she is billing. Without this requirement, there could be an insufficient nexus with the physician's or other practitioner's services being billed on a claim to Medicare as incident to services and the actual services being furnished to the Medicare beneficiary by the auxiliary personnel. Therefore, we are proposing to amend Sec. 410.26(b)(5) to state that the physician or other practitioner who bills for incident to services must also be the physician or other practitioner who directly supervises the auxiliary personnel who provide the incident to services. Also, to further clarify the meaning of the proposed amendment to this regulation, we are proposing to remove the last sentence from Sec. 410.26(b)(5) specifying that the physician (or other practitioner) supervising the auxiliary personnel need not be the same physician (or other practitioner) upon whose professional service the incident to service is based.

    3. Auxiliary Personnel Who Have Been Excluded or Revoked From Medicare

    As a condition of Medicare payment, auxiliary personnel who, under the direct supervision of a physician or other practitioner, provide incident to services to Medicare beneficiaries must comply with all applicable Federal and State laws. This includes not having been excluded from Medicare, Medicaid and all other federally funded health care programs by the Office of Inspector General. We are proposing to amend the regulation to explicitly prohibit auxiliary personnel from providing incident to services who have either been excluded from Medicare, Medicaid and all other federally funded health care programs by the Office of Inspector General or who have had their enrollment revoked for any reason. These excluded or revoked individuals are already prohibited from providing services to Medicare beneficiaries, so this proposed revision is an additional safeguard to ensure that these excluded or revoked individuals are not providing incident to services and supplies under the direct supervision of a physician or other authorized supervising practitioner. These proposed revisions to the incident to regulations will provide the Medicare program with additional recourse for denying or recovering Part B payment for incident to services and supplies that are not furnished in compliance with our program requirements.

    4. Compliance and Oversight

    We recognize that there are many ways in which compliance with these requirements could be consistently and fairly assured across the Medicare program. In considering implementation of these proposals, we wish to be mindful of the need to minimize or eliminate any practitioner administrative burden while at the same time ensuring that practitioners are not subjected to unnecessary audits or

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    placed at risk of inadvertent non-compliance. Therefore, while we believe that the initial responsibility of compliance rests with the practitioner, we invite comments through this proposed rule about possible approaches we could take to improve our ability ensure that incident to services are provided to beneficiaries by qualified individuals in a manner consistent with Medicare statute and regulations. We invite commenters to consider the options we will consider, such as creating new categories of enrollment, implementing a mechanism for registration short of full enrollment, requiring the use of claim elements such as modifiers to identify the types of individuals providing services, or relying on post-payment audits, investigations and recoupments by CMS contractors such as Recovery Auditors or Program Integrity Contractors. We will consider these comments in the course of implementing the proposals we finalize in rulemaking for CY 2016, and further, if we decide in the future that additional regulations or guidance will be necessary to monitor compliance with these or other requirements surrounding incident to services.

    L. Portable X-ray: Billing of the Transportation Fee

    Portable X-ray suppliers receive a transportation fee for transporting portable X-ray equipment to the location where portable X-

    rays are taken. If more than one patient at the same location is X-

    rayed, the portable X-ray transportation fee is allocated among the patients. We have received feedback that some portable x-ray suppliers have been operating under the assumption that the prorated transportation payment when more than one patient is receiving portable X-ray services at the same location refers to only a subset of patients. The Medicare Claims Processing Manual (Pub. 100-4, Chapter 13, Section 90.3) currently states:

    Carriers shall allow only a single transportation payment for each trip the portable X-ray supplier makes to a particular location. When more than one Medicare patient is X-rayed at the same location, e.g., a nursing home, prorate the single fee schedule transportation payment among all patients receiving the services. For example, if two patients at the same location receive X-rays, make one-half of the transportation payment for each.

    In some jurisdictions, Medicare contractors have been allowing the portable X-ray transportation fee to be allocated only among Medicare Part B beneficiaries. In other jurisdictions, Medicare contractors have required the transportation fee to be allocated among all Medicare patients (Parts A and B). We believe it would be more appropriate to allocate the transportation fee among all patients who receive portable X-ray services in a single trip. Medicare should not pay for more than its share of the transportation costs for portable X-ray services.

    We are proposing to revise the Medicare Claims Processing Manual (Pub. 100-4, Chapter 13, Section 90.3) to remove the word ``Medicare'' before ``patient'' in section 90.3. We are also proposing to clarify that this subregulatory guidance means that, when more than one patient is X-rayed at the same location, the single transportation payment under the PFS is to be prorated among all patients (Medicare Parts A and B, and non-Medicare) receiving portable X-ray services during that trip, regardless of their insurance status.

    For example, for portable x-ray services furnished at a SNF, we believe that the transportation fee should be allocated among all patients receiving portable X-ray services at the same location in a single trip irrespective of whether the patient is in a Part A stay, a Part B patient, or not a Medicare beneficiary at all. If the patient is in a Part A SNF stay, payment for the allocated portion of the transportation fee (and the X-ray) would be the SNF's responsibility. For a privately insured patient, it would be the responsibility of that patient's insurer. For a Medicare Part B patient, payment would be made under Part B for the share of the transportation fee attributable to that patient. We welcome comments on this proposal to determine Medicare Part B's portion of the transportation payment by prorating the single fee among all patients.

  39. Technical Correction: Waiver of Deductible for Anesthesia Services Furnished on the Same Date as a Planned Screening Colorectal Cancer Test

    Section 1833(b)(1) of the Act waives the deductible for colorectal cancer screening tests regardless of the code that is billed for the establishment of a diagnosis as a result of the test, or the removal of tissue or other matter or other procedure that is furnished in connection with, as a result of, and in the same clinical encounter as the screening test. To implement this statutory provision, we amended our regulation at Sec. 410.160 to add to the list of services to which the deductible does not apply, beginning January 1, 2011, a surgical service furnished in connection with, as a result of, and in the same clinical encounter as a planned colorectal cancer screening test. A surgical service furnished in connection with, as a result of, and in the same clinical encounter as a colorectal cancer screening test means a surgical service furnished on the same date as a planned colorectal cancer screening test as described in Sec. 410.37.

    In the CY 2015 PFS final rule with comment period, we modified the regulatory definition of colorectal cancer screening test with regard to colonoscopies to include anesthesia services whether billed as part of the colonoscopy service or separately. (See Sec. 410.37(a)(1)(iii) of our regulations). In the preamble to the final rule, we stated that the statutory waiver of deductible would apply to anesthesia services furnished in conjunction with a colorectal cancer screening test even when a polyp or other tissue is removed during a colonoscopy (79 FR 67731). We also indicated that practitioners should report anesthesia services with the PT modifier in such circumstances. The final policy was implemented for services furnished during CY 2015. While we modified the definition of colorectal cancer screening services in the regulation at Sec. 410.37(a)(1)(iii) to include anesthesia furnished with a screening colonoscopy, we did not make a conforming change to our regulations to expressly reflect the inapplicability of the deductible to those anesthesia services.

    To better reflect our policy in the regulations, we propose a technical correction to amend Sec. 410.160(b)(8) to expressly recognize anesthesia services. Specifically, we propose to amend Sec. 410.160(b)(8) to add ``and beginning January 1, 2015, for an anesthesia service,'' following the first use of the phrase ``a surgical service'' and to add ``or anesthesia'' following the word ``surgical'' each time it is used in the second sentence of Sec. 410.160(b)(8). This amendment to our regulation will ensure that both surgical or anesthesia services furnished in connection with, as a result of, and in the same clinical encounter as a colorectal cancer screening test will be exempt from the deductible requirement when furnished on the same date as a planned colorectal cancer screening test as described in Sec. 410.37.

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    III. Other Provisions of the Proposed Regulations

  40. Proposed Provisions associated with the Ambulance Fee Schedule

    1. Overview of Ambulance Services

    a. Ambulance Services

    Under the ambulance fee schedule, the Medicare program pays for ambulance transportation services for Medicare beneficiaries when other means of transportation are contraindicated by the beneficiary's medical condition and all other coverage requirements are met. Ambulance services are classified into different levels of ground (including water) and air ambulance services based on the medically necessary treatment provided during transport.

    These services include the following levels of service:

    For Ground--

    Basic Life Support (BLS) (emergency and non-emergency)

    Advanced Life Support, Level 1 (ALS1) (emergency and non-emergency)

    Advanced Life Support, Level 2 (ALS2)

    Paramedic ALS Intercept (PI)

    Specialty Care Transport (SCT)

    For Air--

    Fixed Wing Air Ambulance (FW)

    Rotary Wing Air Ambulance (RW)

    b. Statutory Coverage of Ambulance Services

    Under sections 1834(l) and 1861(s)(7) of the Act, Medicare Part B (Supplemental Medical Insurance) covers and pays for ambulance services, to the extent prescribed in regulations, when the use of other methods of transportation would be contraindicated by the beneficiary's medical condition.

    The House Ways and Means Committee and Senate Finance Committee Reports that accompanied the 1965 Social Security Amendments suggest that the Congress intended that--

    The ambulance benefit cover transportation services only if other means of transportation are contraindicated by the beneficiary's medical condition; and

    Only ambulance service to local facilities be covered unless necessary services are not available locally, in which case, transportation to the nearest facility furnishing those services is covered (H.R. Rep. No. 213, 89th Cong., 1st Sess. 37 and Rep. No. 404, 89th Cong., 1st Sess. Pt 1, 43 (1965)).

    The reports indicate that transportation may also be provided from one hospital to another, to the beneficiary's home, or to an extended care facility.

    c. Medicare Regulations for Ambulance Services

    Our regulations relating to ambulance services are set forth at 42 CFR part 410, subpart B and 42 CFR part 414, subpart H. Section 410.10(i) lists ambulance services as one of the covered medical and other health services under Medicare Part B. Therefore, ambulance services are subject to basic conditions and limitations set forth at Sec. 410.12 and to specific conditions and limitations included at Sec. 410.40 and Sec. 410.41. Part 414, subpart H, describes how payment is made for ambulance services covered by Medicare.

    2. Ambulance Extender Provisions

    a. Amendment to Section 1834(l)(13) of the Act

    Section 146(a) of the MIPPA amended section 1834(l)(13)(A) of the Act to specify that, effective for ground ambulance services furnished on or after July 1, 2008 and before January 1, 2010, the ambulance fee schedule amounts for ground ambulance services shall be increased as follows:

    For covered ground ambulance transports that 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.

    For covered ground ambulance transports that 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.

    The payment add-ons under section 1834(l)(13)(A) of the Act have been extended several times. Most recently, section 203(a) of the Medicare Access and CHIP Reauthorization Act of 2015 (Pub. L. 114-10, enacted on April 16, 2015) amended section 1834(l)(13)(A) of the Act to extend the payment add-ons through December 31, 2017. Thus, these payment add-ons apply to covered ground ambulance transports furnished before January 1, 2018. We are proposing to revise Sec. 414.610(c)(1)(ii) to conform the regulations to this statutory requirement. (For a discussion of past legislation extending section 1834(l)(13) of the Act, please see the CY 2014 PFS final rule with comment period (78 FR 74438 through 74439)).

    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.

    b. Amendment to Section 1834(l)(12) of the Act

    Section 414(c) of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (Pub. L. 108-173, enacted on December 8, 2003) (MMA) added section 1834(l)(12) to the Act, which specified that, in the case of ground ambulance services furnished on or after July 1, 2004, and before January 1, 2010, for which transportation originates in a qualified rural area (as described in the statute), the Secretary shall provide for a percent increase in the base rate of the fee schedule for such transports. The statute requires this percent increase to be based on the Secretary's estimate of the average cost per trip for such services (not taking into account mileage) in the lowest quartile of all rural county populations as compared to the average cost per trip for such services (not taking into account mileage) in the highest quartile of rural county populations. Using the methodology specified in the July 1, 2004 interim final rule (69 FR 40288), we determined that this percent increase was equal to 22.6 percent. As required by the MMA, this payment increase was applied to ground ambulance transports that originated in a ``qualified rural area,'' that is, to transports that originated in a rural area included in those areas comprising the lowest 25th percentile of all rural populations arrayed by population density. For this purpose, rural areas included Goldsmith areas (a type of rural census tract). This rural bonus is sometimes referred to as the ``Super Rural Bonus'' and the qualified rural areas (also known as ``super rural'' areas) are identified during the claims adjudicative process via the use of a data field included in the CMS-supplied ZIP code file.

    The Super Rural Bonus under section 1834(l)(12) of the Act has been extended several times. Most recently, section 203(b) of the Medicare Access and CHIP Reauthorization Act of 2015 amended section 1834(l)(12)(A) of the Act to extend this rural bonus through December 31, 2017. Therefore, we are continuing to apply the 22.6 percent rural bonus described above (in the same manner as in previous years) to ground ambulance services with dates of service before January 1, 2018 where transportation originates in a qualified rural area. Accordingly, we are proposing to revise Sec. 414.610(c)(5)(ii) to conform the regulations to this statutory requirement. (For a discussion of past legislation extending section 1834(l)(12) of the Act, please see the CY 2014 PFS

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    final rule with comment period (78 FR 74439 through 74440)).

    This statutory provision is self-implementing. It requires an extension of this rural bonus (which was previously established by the Secretary) through December 31, 2017, and does not require any substantive exercise of discretion on the part of the Secretary.

    3. Changes in Geographic Area Delineations for Ambulance Payment

    a. Background

    In the CY 2015 PFS final rule with comment period (79 FR 67744 through 67750) as amended by the correction issued December 31, 2014 (79 FR 78716 through 78719), we adopted, beginning in CY 2015, the revised OMB delineations as set forth in OMB's February 28, 2013 bulletin (No. 13-01) and the most recent modifications of the Rural-

    Urban Commuting Area (RUCA) codes for purposes of payment under the ambulance fee schedule. With respect to the updated RUCA codes, we designated any census tracts falling at or above RUCA level 4.0 as rural areas. In addition, we stated that none of the super rural areas would lose their status upon implementation of the revised OMB delineations and updated RUCA codes. After publication of the CY 2015 PFS final rule with comment period and the correction, we received feedback and comments from stakeholders expressing concerns about the implementation of the new geographic area delineations finalized in that rule (as corrected). In response to these concerns, we are clarifying our implementation of the revised OMB delineations and the updated RUCA codes in CY 2015, and reproposing the implementation of the revised OMB delineations and updated RUCA codes for CY 2016 and subsequent calendar years. We are requesting public comment on our proposals, as further discussed in section III A.3.b. of this proposed rule.

    b. Provisions of the Proposed Rule

    Under section 1834(l)(2)(C) of the Act, the Secretary is required to consider appropriate regional and operational differences in establishing the ambulance fee schedule. Historically, the Medicare ambulance fee schedule has used the same geographic area designations as the acute care hospital inpatient prospective payment system (IPPS) and other Medicare payment systems to take into account appropriate regional (urban and rural) differences. This use of consistent geographic standards for Medicare payment purposes provides for consistency across the Medicare program.

    The geographic areas used under the ambulance fee schedule effective in CY 2007 were based on OMB standards published on December 27, 2000 (65 FR 82228 through 82238), Census 2000 data, and Census Bureau population estimates for 2007 and 2008 (OMB Bulletin No. 10-02). For a discussion of OMB's delineation of Core-Based Statistical Areas (CBSAs) and our implementation of the CBSA definitions under the ambulance fee schedule, we refer readers to the preamble of the CY 2007 Ambulance Fee Schedule proposed rule (71 FR 30358 through 30361) and the CY 2007 PFS final rule with comment period (71 FR 69712 through 69716). On February 28, 2013, OMB issued OMB Bulletin No. 13-01, which established revised delineations for Metropolitan Statistical Areas (MSAs), Micropolitan Statistical Areas, and Combined Statistical Areas, and provided guidance on the use of the delineations of these statistical areas. A copy of this bulletin may be obtained at http://www.whitehouse.gov/sites/default/files/omb/bulletins/2013/b-13-01.pdf. According to OMB, this bulletin provides the delineations of all Metropolitan Statistical Areas, Metropolitan Divisions, Micropolitan Statistical Areas, Combined Statistical Areas, and New England City and Town Areas in the United States and Puerto Rico based on the standards published on June 28, 2010, in the Federal Register (75 FR 37246-37252) and Census Bureau data. OMB defines an MSA as a CBSA associated with at least one urbanized area that has a population of at least 50,000, and a Micropolitan Statistical Area (referred to in this discussion as a Micropolitan Area) as a CBSA associated with at least one urban cluster that has a population of at least 10,000 but less than 50,000 (75 FR 37252). Counties that do not qualify for inclusion in a CBSA are deemed ``Outside CBSAs.'' We note that, when referencing the new OMB geographic boundaries of statistical areas, we are using the term ``delineations'' consistent with OMB's use of the term (75 FR 37249).

    Although the revisions OMB published on February 28, 2013 were not as sweeping as the changes made when we adopted the CBSA geographic designations for CY 2007, the February 28, 2013 OMB bulletin did contain a number of significant changes. For example, there are new CBSAs, urban counties that became rural, rural counties that became urban, and existing CBSAs that were split apart. As we stated in the CY 2015 PFS final rule with comment period (79 FR 67745), we reviewed our findings and impacts relating to the new OMB delineations, and found no compelling reason to further delay implementation. We stated in the CY 2015 final rule with comment period, and we continue to believe, that it is important for the ambulance fee schedule to use the latest labor market area delineations available as soon as reasonably possible to maintain a more accurate and up-to-date payment system that reflects the reality of population shifts.

    Additionally, in the FY 2015 IPPS final rule (79 FR 49952), we adopted OMB's revised delineations to identify urban areas and rural areas for purposes of the IPPS wage index. For the reasons discussed in this section above, we believe that it would be appropriate to adopt the same geographic area delineations for use under the ambulance fee schedule as are used under the IPPS and other Medicare payment systems. Thus, we are proposing to continue implementation of the new OMB delineations as described in the February 28, 2013 OMB Bulletin No. 13-

    01 for CY 2016 and subsequent CYs to more accurately identify urban and rural areas for ambulance fee schedule payment purposes. We continue to believe that the updated OMB delineations more realistically reflect rural and urban populations, and that the use of such delineations under the ambulance fee schedule would result in more accurate payment. Under the ambulance fee schedule, consistent with our current definitions of urban and rural areas (Sec. 414.605), in CY 2016 and subsequent CYs, MSAs would continue to be recognized as urban areas, while Micropolitan and other areas outside MSAs, and rural census tracts within MSAs (as discussed below in this section), would continue to be recognized as rural areas. We invite public comments on this proposal.

    In addition to the OMB's statistical area delineations, the current geographic areas used in the ambulance fee schedule also are based on rural census tracts determined under the most recent version of the Goldsmith Modification. These rural census tracts within MSAs are considered rural areas under the ambulance fee schedule (see Sec. 414.605). For certain rural add-on payments, section 1834(l) of the Act requires that we use the most recent version of the Goldsmith Modification to determine rural census tracts within MSAs. In the CY 2007 PFS final rule with comment period (71 FR 69714 through 69716), we adopted the most recent (at that time) version of the

    Page 41789

    Goldsmith Modification, designated as RUCA codes. RUCA codes use urbanization, population density, and daily commuting data to categorize every census tract in the country. For a discussion about RUCA codes, we refer the reader to the CY 2007 PFS final rule with comment period (71 FR 69714 through 69716) and the CY 2015 PFS final rule with comment period (79 FR 67745 through 67746). As stated previously, on February 28, 2013, OMB issued OMB Bulletin No. 13-01, which established revised delineations for Metropolitan Statistical Areas, Micropolitan Statistical Areas, and Combined Statistical Areas, and provided guidance on the use of the delineations of these statistical areas. Several modifications of the RUCA codes were necessary to take into account updated commuting data and the revised OMB delineations. We refer readers to the U.S. Department of Agriculture's Economic Research Service Web site for a detailed listing of updated RUCA codes found at http://www.ers.usda.gov/data-products/rural-urban-commuting-area-codes.aspx. The updated RUCA code definitions were introduced in late 2013 and are based on data from the 2010 decennial census and the 2006-2010 American Community Survey. Information regarding the American Community Survey can be found at http://www.ers.usda.gov/data-products/rural-urban-commuting-area-codes.aspx. We believe that the most recent RUCA codes provide more accurate and up-to-date information regarding the rurality of census tracts throughout the country. Accordingly, we are proposing to continue to use the most recent modifications of the RUCA codes for CY 2016 and subsequent CYs, to recognize levels of rurality in census tracts located in every county across the nation, for purposes of payment under the ambulance fee schedule. If we continue to use the most recent RUCA codes, many counties that are designated as urban at the county level based on population would continue to have rural census tracts within them that would be recognized as rural areas through our use of RUCA codes.

    As we stated in the CY 2015 PFS final rule with comment period (79 FR 67745), the 2010 Primary RUCA codes are as follows:

    (1) Metropolitan area core: primary flow with an urbanized area (UA).

    (2) Metropolitan area high commuting: primary flow 30 percent or more to a UA.

    (3) Metropolitan area low commuting: primary flow 10 to 30 percent to a UA.

    (4) Micropolitan area core: primary flow within an Urban Cluster of 10,000 to 49,999 (large UC).

    (5) Micropolitan high commuting: primary flow 30 percent or more to a large UC.

    (6) Micropolitan low commuting: primary flow 10 to 30 percent to a large UC.

    (7) Small town core: primary flow within an Urban Cluster of 2,500 to 9,999 (small UC).

    (8) Small town high commuting: primary flow 30 percent or more to a small UC.

    (9) Small town low commuting: primary flow 10 to 30 percent to a small UC.

    (10) Rural areas: primary flow to a tract outside a UA or UC.

    Based on this classification, and consistent with our current policy as set forth in the CY 2015 PFS final rule with comment period (79 FR 67745), we are proposing to continue to designate any census tracts falling at or above RUCA level 4.0 as rural areas for purposes of payment for ambulance services under the ambulance fee schedule. As discussed in the CY 2007 PFS final rule with comment period (71 FR 69715) and the CY 2015 PFS final rule with comment period (79 FR 67745), the Office of Rural Health Policy within the Health Resources and Services Administration (HRSA) determines eligibility for its rural grant programs through the use of the RUCA code methodology. Under this methodology, HRSA designates any census tract that falls in RUCA level 4.0 or higher as a rural census tract. In addition to designating any census tracts falling at or above RUCA level 4.0 as rural areas, under the updated RUCA code definitions, HRSA has also designated as rural census tracts those census tracts with RUCA codes 2 or 3 that are at least 400 square miles in area with a population density of no more than 35 people. We refer readers to HRSA's Web site at ftp://ftp.hrsa.gov/ruralhealth/Eligibility2005.pdf for additional information. Consistent with the HRSA guidelines discussed above and the policy we adopted in the CY 2015 PFS final rule with comment period (79 FR 67750), we are proposing for CY 2016 and subsequent CYs, to designate as rural areas those census tracts that fall at or above RUCA level 4.0. We continue to believe that this HRSA guideline accurately identifies rural census tracts throughout the country, and thus would be appropriate to apply for ambulance fee schedule payment purposes.

    Also, consistent with the policy we finalized in the CY 2015 PFS final rule with comment period (79 FR 67749), we would not designate as rural areas those census tracts that fall in RUCA levels 2 or 3 that are at least 400 square miles in area with a population density of no more than 35 people. We have determined that it is not feasible to implement this guideline due to the complexities of identifying these areas at the ZIP code level. We do not have sufficient information available to identify the ZIP codes that fall in these specific census tracts. Also, payment under the ambulance fee schedule is based on the ZIP codes; therefore, if the ZIP code is predominantly metropolitan but has some rural census tracts, we do not split the ZIP code areas to distinguish further granularity to provide different payments within the same ZIP code. We believe that payment for all ambulance transportation services at the ZIP code level provides for a more consistent and administratively feasible payment system. For example, if we were to pay based on ZIP codes for some areas and counties or census tracts for other areas, there are circumstances where ZIP codes cross county or census tract borders and where counties or census tracts cross ZIP code borders. Such overlaps in geographic designations would complicate our ability to appropriately assign ambulance transportation services to geographic areas for payment under the ambulance fee schedule. Therefore, under the ambulance fee schedule, we would not designate as rural areas those census tracts that fall in RUCA levels 2 or 3 that are at least 400 square miles in area with a population density of no more than 35 people.

    We invite public comments on our proposals, as discussed in this proposed rule, to continue to use the updated RUCA codes under the ambulance fee schedule for CY 2016 and subsequent CYs.

    As we stated in the CY 2015 PFS proposed rule (79 FR 40374), the adoption of the most current OMB delineations and the updated RUCA codes would affect whether certain areas are recognized as rural or urban. The distinction between urban and rural is important for ambulance payment purposes because urban and rural transports are paid differently. The determination of whether a transport is urban or rural is based on the point of pick-up for the transport; thus, a transport is paid differently depending on whether the point of pick-up is in an urban or a rural area. During claims processing, a geographic designation of urban, rural, or super rural is assigned to each claim for an ambulance

    Page 41790

    transport based on the point of pick-up ZIP code that is indicated on the claim.

    The continued implementation of the revised OMB delineations and the updated RUCA codes would continue to affect whether or not transports would be eligible for rural adjustments under the ambulance fee schedule statute and regulations. For ground ambulance transports where the point of pick-up is in a rural area, the mileage rate is increased by 50 percent for each of the first 17 miles (Sec. 414.610(c)(5)(i)). For air ambulance services where the point of pick-

    up is in a rural area, the total payment (base rate and mileage rate) is increased by 50 percent (Sec. 414.610(c)(5)(i)).

    Section 1834(l)(12) of the Act (as amended most recently by section 203(b) of the Medicare Access and CHIP Reauthorization Act of 2015) specifies that, for services furnished during the period July 1, 2004 through December 31, 2017, the payment amount for the ground ambulance base rate is increased by a ``percent increase'' (Super Rural Bonus) where the ambulance transport originates in a ``qualified rural area,'' which is a rural area that we determine to be in the lowest 25th percentile of all rural populations arrayed by population density (also known as a ``super rural area''). We implement this Super Rural Bonus in Sec. 414.610(c)(5)(ii). As discussed in section III.A.2.b. of this proposed rule, we are proposing to revise Sec. 414.610(c)(5)(ii) to conform the regulations to this statutory requirement. As we stated in the CY 2015 PFS proposed rule (79 FR 40374) and final rule with comment period (79 FR 67746), adoption of the revised OMB delineations and the updated RUCA codes would have no negative impact on ambulance transports in super rural areas, as none of the current super rural areas would lose their status due to the revised OMB delineations and the updated RUCA codes. Furthermore, under section 1834(l)(13) of the Act (as amended most recently by section 203(a) of the Medicare Access and CHIP Reauthorization Act of 2015), for ground ambulance transports furnished through December 31, 2017, transports originating in rural areas are paid based on a rate (both base rate and mileage rate) that is 3 percent higher than otherwise is applicable. (See also Sec. 414.610(c)(1)(ii)). As discussed in section III.A.2.a. of this proposed rule, we are proposing to revise Sec. 414.610(c)(1)(ii) to conform the regulations to this statutory requirement.

    Similar to our discussion in the CY 2015 PFS proposed rule (79 FR 40374) and final rule with comment period (79 FR 67746), if we continue to use OMB's revised delineations and the updated RUCA codes for CY 2016 and subsequent CYs, ambulance providers and suppliers that pick up Medicare beneficiaries in areas that would be Micropolitan or otherwise outside of MSAs based on OMB's revised delineations or in a rural census tract of an MSA based on the updated RUCA codes (but were within urban areas under the geographic delineations in effect in CY 2014) would continue to experience increases in payment for such transports (as compared to the CY 2014 geographic delineations) because they may be eligible for the rural adjustment factors discussed above in this section. In addition, those ambulance providers and suppliers that pick up Medicare beneficiaries in areas that would be urban based on OMB's revised delineations and the updated RUCA codes (but were previously in Micropolitan Areas or otherwise outside of MSAs, or in a rural census tract of an MSA under the geographic delineations in effect in CY 2014) would continue to experience decreases in payment for such transports (as compared to the CY 2014 geographic delineations) because they would no longer be eligible for the rural adjustment factors discussed above in this section.

    The continued use of the revised OMB delineations and the updated RUCA codes for CY 2016 and subsequent CYs would mean the continued recognition of urban and rural boundaries based on the population migration that occurred over a 10-year period, between 2000 and 2010. As discussed above in this section, we are proposing to continue to use the updated RUCA codes to identify rural census tracts within MSAs, such that any census tracts falling at or above RUCA level 4.0 would continue to be designated as rural areas. In order to determine which ZIP codes are included in each such rural census tract, we are proposing to continue to use the ZIP code approximation file developed by HRSA. This file includes the 2010 RUCA code designation for each ZIP code and can be found at http://www.ers.usda.gov/data-products/rural-urban-commuting-area-codes.aspx. If ZIP codes are added over time to the USPS ZIP code file (and thus are not included in the 2010 ZIP code approximation file provided to us by HRSA) or if ZIP codes are revised over time, we would determine the appropriate urban/rural designation for such ZIP code based on any updates provided on the HRSA and OMB Web sites, located at http://www.ers.usda.gov/data-products/rural-urban-commuting-area-codes.aspx and http://www.whitehouse.gov/sites/default/files/omb/bulletins/2013/b-13-01.pdf.

    Based on the April 2015 USPS ZIP code file that we are using in this proposed rule to assess the impacts of the revised geographic delineations, there are a total of 42,925 ZIP codes in the U.S. Table 16 sets forth an analysis of the number of ZIP codes that changed urban/rural status in each U.S. state and territory after CY 2014 due to our implementation of the revised OMB delineations and the updated RUCA codes beginning in CY 2015, using the April 2015 USPS ZIP code file, the revised OMB delineations, and the updated RUCA codes (including the RUCA ZIP code approximation file discussed above). Based on this data, the geographic designations for approximately 95.22 percent of ZIP codes are unchanged by OMB's revised delineations and the updated RUCA codes. Similar to the analysis set forth in the CY 2015 PFS final rule with comment period, as corrected (79 FR 78716 through 78719), as reflected in Table 16, more ZIP codes have changed from rural to urban (1,600 or 3.73 percent) than from urban to rural (451 or 1.05 percent). In general, it is expected that ambulance providers and suppliers in 451 ZIP codes within 42 states, may continue to experience payment increases under the revised OMB delineations and the updated RUCA codes, as these areas have been redesignated from urban to rural. The state of Ohio has the most ZIP codes that changed from urban to rural with a total of 54, or 3.63 percent. Ambulance providers and suppliers in 1,600 ZIP codes within 44 states and Puerto Rico may continue to experience payment decreases under the revised OMB delineations and the updated RUCA codes, as these areas have been redesignated from rural to urban. The state of West Virginia has the most ZIP codes that changed from rural to urban (149 or 15.92 percent). As discussed above, these findings are illustrated in Table 16.

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    Table 16--ZIP Code Analysis Based on OMB's Revised Delineations and Updated RUCA Codes

    --------------------------------------------------------------------------------------------------------------------------------------------------------

    Percentage of

    Total ZIP Total ZIP Percentage of Total ZIP Percentage of Total ZIP total ZIP

    State/Territory * codes codes changed total ZIP codes changed total ZIP codes not codes not

    rural to urban codes urban to rural codes changed changed

    --------------------------------------------------------------------------------------------------------------------------------------------------------

    AK...................................... 276 0 0.00 0 0.00 276 100.00

    AL...................................... 854 43 5.04 8 0.94 803 94.03

    AR...................................... 725 19 2.62 9 1.24 697 96.14

    AS...................................... 1 0 0.00 0 0.00 1 100.00

    AZ...................................... 569 21 3.69 7 1.23 541 95.08

    CA...................................... 2723 85 3.12 43 1.58 2595 95.30

    CO...................................... 677 4 0.59 9 1.33 664 98.08

    CT...................................... 445 37 8.31 0 0.00 408 91.69

    DC...................................... 303 0 0.00 0 0.00 303 100.00

    DE...................................... 99 6 6.06 0 0.00 93 93.94

    EK...................................... 63 0 0.00 0 0.00 63 100.00

    EM...................................... 857 35 4.08 4 0.47 818 95.45

    FL...................................... 1513 69 4.56 9 0.59 1435 94.84

    FM...................................... 4 0 0.00 0 0.00 4 100.00

    GA...................................... 1032 47 4.55 4 0.39 981 95.06

    GU...................................... 21 0 0.00 0 0.00 21 100.00

    HI...................................... 143 9 6.29 3 2.10 131 91.61

    IA...................................... 1080 20 1.85 3 0.28 1057 97.87

    ID...................................... 335 0 0.00 0 0.00 335 100.00

    IL...................................... 1629 68 4.17 7 0.43 1554 95.40

    IN...................................... 1000 33 3.30 20 2.00 947 94.70

    KY...................................... 1030 30 2.91 5 0.49 995 96.60

    LA...................................... 739 69 9.34 1 0.14 669 90.53

    MA...................................... 751 8 1.07 9 1.20 734 97.74

    MD...................................... 630 69 10.95 0 0.00 561 89.05

    ME...................................... 505 5 0.99 12 2.38 488 96.63

    MH...................................... 2 0 0.00 0 0.00 2 100.00

    MI...................................... 1185 22 1.86 21 1.77 1142 96.37

    MN...................................... 1043 31 2.97 7 0.67 1005 96.36

    MP...................................... 3 0 0.00 0 0.00 3 100.00

    MS...................................... 541 14 2.59 1 0.18 526 97.23

    MT...................................... 411 0 0.00 3 0.73 408 99.27

    NC...................................... 1102 87 7.89 10 0.91 1005 91.20

    ND...................................... 419 2 0.48 0 0.00 417 99.52

    NE...................................... 632 7 1.11 6 0.95 619 97.94

    NH...................................... 292 0 0.00 2 0.68 290 99.32

    NJ...................................... 748 1 0.13 2 0.27 745 99.60

    NM...................................... 438 4 0.91 2 0.46 432 98.63

    NV...................................... 257 1 0.39 2 0.78 254 98.83

    NY...................................... 2246 84 3.74 42 1.87 2120 94.39

    OH...................................... 1487 23 1.55 54 3.63 1410 94.82

    OK...................................... 791 5 0.63 7 0.88 779 98.48

    OR...................................... 496 26 5.24 9 1.81 461 92.94

    PA...................................... 2244 129 5.75 38 1.69 2077 92.56

    PR...................................... 177 21 11.86 0 0.00 156 88.14

    PW...................................... 2 0 0.00 0 0.00 2 100.00

    RI...................................... 91 2 2.20 1 1.10 88 96.70

    SC...................................... 544 47 8.64 2 0.37 495 90.99

    SD...................................... 418 0 0.00 1 0.24 417 99.76

    TN...................................... 814 52 6.39 12 1.47 750 92.14

    TX...................................... 2726 64 2.35 32 1.17 2630 96.48

    UT...................................... 360 2 0.56 0 0.00 358 99.44

    VA...................................... 1277 98 7.67 19 1.49 1160 90.84

    VI...................................... 16 0 0.00 0 0.00 16 100.00

    VT...................................... 309 3 0.97 0 0.00 306 99.03

    WA...................................... 744 17 2.28 6 0.81 721 96.91

    WI...................................... 919 19 2.07 5 0.54 895 97.39

    WK...................................... 711 11 1.55 7 0.98 693 97.47

    WM...................................... 342 2 0.58 3 0.88 337 98.54

    WV...................................... 936 149 15.92 3 0.32 784 83.76

    WY...................................... 198 0 0.00 1 0.51 197 99.49

    ---------------------------------------------------------------------------------------------------------------

    TOTALS.............................. 42,925 1600 3.73 451 1.05 40,874 95.22

    --------------------------------------------------------------------------------------------------------------------------------------------------------

    * ZIP code analysis includes U.S. States and Territories (FM--Federated States of Micronesia, GU--Guam, MH--Marshall Islands, MP--Northern Mariana

    Islands, PW--Palau, AS--American Samoa; VI--Virgin Islands; PR--Puerto Rico). Missouri is divided into east and west regions due to work distribution

    of the Medicare Administrative Contractors (MACs): EM--East Missouri, WM--West Missouri. Johnson and Wyandotte counties in Kansas were changed as of

    January 2010 to East Kansas (EK) and the rest of the state is West Kansas (WK).

    Page 41792

    For more detail on the impact of our proposals, in addition to Table 16, the following files are available through the Internet on the Ambulance Fee Schedule Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AmbulanceFeeSchedule/index.html: ZIP Codes By State Changed From Urban To Rural: ZIP Codes By State Changed From Rural To Urban: List of ZIP Codes With RUCA Code Designations: and Complete List of ZIP Codes.

    As discussed in the CY 2015 PFS final rule with comment period (79 FR 67750), we believe the most current OMB statistical area delineations, coupled with the updated RUCA codes, more accurately reflect the contemporary urban and rural nature of areas across the country, and thus we believe the use of the most current OMB delineations and RUCA codes under the ambulance fee schedule will enhance the accuracy of ambulance fee schedule payments. As we discussed in the CY 2015 PFS final rule with comment period (79 FR 67750), we considered, as alternatives, whether it would be appropriate to delay the implementation of the revised OMB delineations and the updated RUCA codes, or to phase in the implementation of the new geographic delineations over a transition period for those ZIP codes losing rural status. We determined that it would not be appropriate to implement a delay or a transition period for the revised geographic delineations for the reasons set forth in the CY 2015 PFS final rule. Similarly, we considered whether a delay in implementation or a transition period would be appropriate for CY 2016 and subsequent CYs. We continue to believe that it is important to use the most current OMB delineations and RUCA codes available as soon as reasonably possible to maintain a more accurate and up-to-date payment system that reflects the reality of population shifts. Because we believe the revised OMB delineations and updated RUCA codes more accurately identify urban and rural areas and enhance the accuracy of the Medicare ambulance fee schedule, we do not believe a delay in implementation or a transition period would be appropriate for CY 2016 and subsequent CYs. Areas that have lost their rural status and become urban have become urban because of recent population shifts. We believe it is important to base payment on the most accurate and up-to-date geographic area delineations available. Furthermore, we believe a delay in implementation of the revised OMB delineations and the updated RUCA codes would be a disadvantage to the ambulance providers or suppliers experiencing payment increases based on these updated and more accurate OMB delineations and RUCA codes. Thus, we are not proposing a delay in implementation or a transition period for the revised OMB delineations and updated RUCA codes for CY 2016 and subsequent CYs.

    We invite public comments on our proposals to continue implementation of the revised OMB delineations as set forth in OMB's February 28, 2013 bulletin (No. 13-01) and the most recent modifications of the RUCA codes as discussed above for CY 2016 and subsequent CYs for purposes of payment under the ambulance fee schedule. In addition, we invite public comments on any alternative methods for implementing the revised OMB delineations and the updated RUCA codes.

    4. Proposed Changes to the Ambulance Staffing Requirement

    Under section 1861(s)(7) of the Act, Medicare Part B covers ambulance services when the use of other methods of transportation is contraindicated by the individual's medical condition, but only to the extent provided in regulations. Section 410.41(b)(1) requires that a vehicle furnishing ambulance services at the Basic Life Support (BLS) level must be staffed by at least two people, one of whom must meet the following requirements: (1) be certified as an emergency medical technician by the state or local authority where the services are furnished, and (2) be legally authorized to operate all lifesaving and life-sustaining equipment on board the vehicle.

    Section 410.41(b)(2) states that, for vehicles furnishing ambulance services at the Advanced Life Support (ALS) level, ambulance providers and suppliers must meet the staffing requirements for vehicles furnishing services at the BLS level. In addition, one of the two staff members must be certified as a paramedic or an emergency medical technician, by the state or local authority where the services are being furnished, to perform one or more ALS services. These staffing requirements are further explained in the Medicare Benefit Policy Manual (Pub. No. 100-02), Chapter 10 (see sections 10.1.2 and 30.1.1)

    In its July 24, 2014 Management Implication Report, 13-0006, entitled ``Medicare Requirements for Ambulance Crew Certification,'' the Office of Inspector General (OIG) discussed its investigation of ambulance suppliers in a state that requires a higher level of training than Medicare requires for ambulance staff. In some instances, OIG found that second crew members: (1) possessed a lower level of training than required by state law, or (2) had purchased or falsified documentation to establish their credentials. The OIG expressed its concern that our current regulations and manual provisions do not set forth licensure or certification requirements for the second crew member. The OIG was informed by federal prosecutors that prosecuting individuals who had purchased or falsified documentation to establish their credentials would be difficult because Medicare had no requirements regarding the second ambulance staff member and the ambulance transports complied with the relevant Medicare regulations and manual provisions for ambulance staffing.

    The OIG recommended that Medicare revise its regulations and manual provisions related to ambulance staffing to parallel the standard used for vehicle requirements at Sec. 410.41(a), which requires that ambulances be equipped in ways that comply with state and local laws. Specifically, the OIG recommended that our regulation and manual provisions addressing ambulance vehicle staffing should indicate that, for Medicare to cover ambulance services furnished to a Medicare beneficiary, the ambulance crew must meet the requirements currently set forth in Sec. 410.41(b) or the state and local requirements, whichever are more stringent. Currently, Sec. 410.41(b) does not require that ambulance vehicle staff comply with all applicable state and local laws. We agree with OIG's concerns and believe that requiring ambulance staff to also comply with state and local requirements would enhance the quality and safety of ambulance services furnished to Medicare beneficiaries.

    Accordingly, we are proposing to revise Sec. 410.41(b) to require that all Medicare-covered ambulance transports must be staffed by at least two people who meet both the requirements of applicable state and local laws where the services are being furnished, and the current Medicare requirements under Sec. 410.41(b). We believe that this would, in effect, require both of the required ambulance vehicle staff to also satisfy any applicable state and local requirements that may be more stringent than those currently set forth at Sec. 410.41(b), consistent with OIG's recommendation. In addition, we are proposing to revise the definition of Basic Life Support (BLS) in Sec. 414.605 to include the proposed revised staffing requirements discussed above for

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    Sec. 410.41(b). These proposed revisions to Sec. 410.41(b) and Sec. 414.605 would account for differences in individual state or local staffing and licensure requirements, better accommodating state or local laws enacted to ensure beneficiaries' health and safety. Likewise, these proposed revisions would strengthen the federal government's ability to prosecute violations associated with such requirements and recover inappropriately or fraudulently received funds from ambulance companies found to be operating in violation of state or local laws. Furthermore, as discussed above, we believe that these proposals would enhance the quality and safety of ambulance services provided to Medicare beneficiaries.

    In addition, we are proposing to revise Sec. 410.41(b) and the definition of Basic Life Support (BLS) in Sec. 414.605 to clarify that, for BLS vehicles, at least one of the staff members must be certified at a minimum as an emergency medical technician-basic (EMT-

    Basic), which we believe would more clearly state our current policy. Currently, these regulations require that, for BLS vehicles, one staff member be certified as an EMT (Sec. 410.41(b)) or EMT-Basic (Sec. 414.605). These proposed revisions to the regulations do not change our current policy, but clarify that one of the BLS vehicle staff members must be certified at the minimum level of EMT-Basic, but may also be certified at a higher level, for example, EMT-intermediate or EMT paramedic.

    Finally, we are proposing to revise the definition of Basic Life Support (BLS) in Sec. 414.605 to delete the last sentence, which sets forth examples of certain state law provisions. This sentence (``For example, only in some states is an EMT-Basic permitted to operate limited equipment on board the vehicle, assist more qualified personnel in performing assessments and interventions, and establish a peripheral intravenous (IV) line''), has been included in the definition of BLS since the ambulance fee schedule was finalized in 2002 (67 FR 9100, Feb. 27, 2002). Because state laws may change over the course of time, we are concerned that this sentence may not accurately reflect the status of the relevant state laws over time. Therefore, we are proposing to delete the last sentence of this definition. Furthermore, we do not believe that the examples set forth in this sentence are necessary to convey the definition of BLS for Medicare coverage and payment purposes.

    We invite public comments on our proposals to revise the ambulance vehicle staffing requirements in Sec. 410.41(b) and Sec. 414.605 as discussed above. If we finalize these proposals, we will revise our manual provisions addressing ambulance vehicle staffing as appropriate, consistent with our finalized policy.

  41. Chronic Care Management (CCM) Services for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)

    1. Background

    a. Primary Care and Care Coordination

    Over the last several years, we have been increasing our focus on primary care, and have explored ways in which care coordination can improve health outcomes and reduce expenditures.

    In the CY 2012 PFS proposed rule (76 FR 42793 through 42794, and 42917 through 42920), and the CY 2012 PFS final rule (76 FR 73063 through 73064), we discussed how primary care services have evolved to focus on preventing and managing chronic disease, and how refinements for payment for post-discharge care management services could improve care management for a beneficiary's transition from the hospital to the community setting. We acknowledged that the care coordination included in services such as office visits does not always describe adequately the non-face-to-face care management work involved in primary care and may not reflect all the services and resources required to furnish comprehensive, coordinated care management for certain categories of beneficiaries, such as those who are returning to a community setting following discharge from a hospital or skilled nursing facility (SNF) stay. We initiated a public discussion on primary care and care coordination services, and stated that we would consider payment enhancements in future rulemaking as part of a multiple year strategy exploring the best means to encourage primary care and care coordination services.

    In the CY 2013 PFS proposed rule (77 FR 44774 through 44775), we noted several initiatives and programs designed to improve payment for, and encourage long-term investment in, care management services. These include the Medicare Shared Savings Program; testing of the Pioneer Accountable Care Organization (ACO) and the Advance Payment ACO model; the Primary Care Incentive Payment (PCIP) Program; the patient-centered medical home model in the Multi-payer Advanced Primary Care Practice (MAPCP) Demonstration; the Federally Qualified Health Center (FQHC) Advanced Primary Care Practice demonstration; the Comprehensive Primary Care (CPC) initiative; and the HHS Strategic Framework on Multiple Chronic Conditions. We also noted that we were monitoring the progress of the AMA Chronic Care Coordination Workgroup in developing codes to describe care transition and care coordination activities, and proposed refinement of the PFS payment for post discharge care management services.

    In the CY 2013 PFS final rule (77 FR 68978 through 68994), we finalized policies for payment of Transitional Care Management (TCM) services, effective January 1, 2013. We adopted two CPT codes (99495 and 99496) to report physician or qualifying nonphysician practitioner care management services for a patient following a discharge from an inpatient hospital or SNF, an outpatient hospital stay for observation or partial hospitalization services, or partial hospitalization in a community mental health center. As a condition for receiving TCM payment, a face-to-face visit was required.

    In the CY 2014 PFS proposed rule (78 FR 43337 through 43343), we proposed to establish separate payment under the PFS for chronic care management (CCM) services and proposed a scope of services and requirements for billing and supervision. In the CY 2014 PFS final rule (78 74414 through 74427), we finalized policies to establish separate payment under the PFS for CCM services furnished to patients with multiple chronic conditions that are expected to last at least 12 months or until the death of the patient, and that place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline. In the CY 2015 PFS final rule (79 FR 67715 through 67730), additional billing requirements were finalized, including the requirement to furnish CCM services using a certified electronic health record or other electronic technology. Payment for CCM services was effective beginning on January 1, 2015, for physicians billing under the PFS.

    b. RHC and FQHC Payment Methodologies

    A RHC or FQHC visit must be a face-to-face encounter between the patient and a RHC or FQHC practitioner (physician, nurse practitioner, physician assistant, certified nurse midwife, clinical psychologist, or clinical social worker, and under certain conditions, an RN or LPN furnishing care to a homebound RHC or FQHC patient) during which time one or more RHC or FQHC services are furnished. A TCM service can also be a RHC or FQHC visit. A Diabetes Self-Management Training

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    (DSMT) service or a Medical Nutrition Therapy (MNT) service furnished by a certified DSMT or MNT provider may also be a FQHC visit.

    RHCs are paid an all-inclusive rate (AIR) for medically-necessary medical and mental health services, and qualified preventive health services furnished on the same day (with some exceptions). In general, the A/B MAC calculates the AIR for each RHC by dividing total allowable costs by the total number of visits for all patients. Productivity, payment limits, and other factors are also considered in the calculation. Allowable costs must be reasonable and necessary and may include practitioner compensation, overhead, equipment, space, supplies, personnel, and other costs incident to the delivery of RHC services. The AIR is subject to a payment limit, except for those RHCs that have an exception to the payment limit. Services furnished incident to a RHC professional service are included in the per-visit payment and are not billed separately.

    FQHCs have also been paid under the AIR methodology; however, on October 1, 2014, FQHCs began to transition to a FQHC PPS system in which they are paid based on the lesser of a national encounter-based rate or their total adjusted charges. The FQHC PPS rate is adjusted for geographic differences in the cost of services by the FQHC geographic adjustment factor. It is also increased by 34 percent when a FQHC furnishes care to a patient that is new to the FQHC or to a beneficiary receiving an Initial Preventive Physical Examination (IPPE) or an Annual Wellness Visit (AWV). Both the AIR and FQHC PPS payment rates were designed to reflect all the services that a RHC or FQHC furnishes in a single day, regardless of the length or complexity of the visit or the number or type of practitioners seen.

    c. Payment for CCM Services

    To address the concern that the non-face-to-face care management work involved in furnishing comprehensive, coordinated care management for certain categories of beneficiaries is not adequately paid for as part of an office visit, beginning on January 1, 2015, practitioners billing under the PFS are paid separately for CCM services under CPT code 99490 when CCM service requirements are met.

    RHCs and FQHCs cannot bill under the PFS for RHC or FQHC services and individual practitioners working at RHCs and FQHCs cannot bill under the PFS for RHC or FQHC services while working at the RHC or FQHC. While many RHCs and FQHCs coordinate services within their own facilities, and may sometimes help to coordinate services outside their facilities, the type of structured care management services that are now payable under the PFS for patients with multiple chronic conditions, particularly for those who are transitioning from a hospital or SNF back into their communities, are not included in the RHC or FQHC payment. This proposed rule proposes to provide an additional payment for the costs of CCM services that are not already captured in the RHC AIR or the FQHC PPS payment, beginning on January 1, 2016. Services that are currently being furnished and paid under the RHC AIR or FQHC PPS payment methodology will not be affected by the ability of the RHC or FQHC to receive payment for additional services that are not included in the RHC AIR or FQHC PPS.

    d. Solicitation of Comments on Payment for CCM Services in RHCs and FQHCs

    In the May 2, 2014 ``Medicare Program: Prospective Payment System for Federally Qualified Health Centers; Changes to Contracting Policies for Rural Health Clinics; and Changes to Clinical Laboratory Improvement Amendments of 1988 Enforcement Actions for Proficiency Testing Referral; Final Rule'' (79 FR 25447), we discussed ways to achieve the Affordable Care Act goal of furnishing integrated and coordinated services, and specifically noted the CCM services program beginning in 2015 for physicians billing under the PFS. We encouraged RHCs and FQHCs to review the CCM services information in the CY 2014 PFS final rule with comment period and submit comments to us on how the CCM services payment could be adapted for RHCs and FQHCs to promote integrated and coordinated care in RHCs and FQHCs.

    All of the comments we received in response to this request were strongly supportive of payment to RHCs and FQHCs for CCM services. Some commenters were concerned that the requirements for electronic exchange of information and interoperability with other providers would be difficult for some entities, and that some patients do not have the resources to receive secure messages via the internet. One commenter suggested that the additional G-codes for CCM services should be sufficient to cover the associated costs of documenting care coordination in FQHCs, and another commenter suggested that we develop a risk-adjusted CCM services fee. We also received subsequent recommendations from the National Association of Rural Health Clinics on various payment options for CCM services in RHCs. These comments were very helpful in forming the basis for this proposal, and we thank the commenters for their comments.

    2. Proposed Payment Methodology and Billing for CCM Services in RHCs and FQHCs

    a. Proposed Payment Methodology and Billing Requirements

    The requirements we are proposing for RHCs and FQHCs to receive payment for CCM services are consistent with those finalized in the CY 2015 PFS final rule with comment period for practitioners billing under the PFS and are summarized in Table 17. We propose to establish payment, beginning on January 1, 2016, for RHCs and FQHCs who furnish a minimum of 20 minutes of qualifying CCM services during a calendar month to patients with multiple (two or more) chronic conditions that are expected to last at least 12 months or until the death of the patient, and that place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline. The CPT code descriptor sets forth the eligibility guidelines for CCM services and will serve as the basis for potential medical review. In accordance with both the CPT instructions and Medicare policy, only one practitioner can bill this code per month, and there are restrictions regarding the billing of other overlapping care management services during the same service period. The following section discusses these aspects of our proposal in more detail and additional information will be communicated in subregulatory guidance.

    We propose that a RHC or FQHC can bill for CCM services furnished by, or incident to, a RHC or FQHC physician, nurse practitioner, physician assistant, or certified nurse midwife for a RHC or FQHC patient once per month, and that only one CCM payment per beneficiary per month can be paid. If another practice furnishes CCM services to a beneficiary, the RHC or FQHC cannot bill for CCM services for the same beneficiary for the same service period. We also propose that TCM and any other program that provides additional payment for care management services (outside of the RHC AIR or FQHC PPS payment) cannot be billed during the same service period.

    For purposes of meeting the minimum 20-minute requirement, the RHC or FQHC could count the time of only one practitioner or auxiliary staff (for example, a nurse, medical assistant, or

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    other individual working under the supervision of a RHC or FQHC physician or other practitioner) at a time, and could not count overlapping intervals such as when two or more RHC or FQHC practitioners are meeting about the patient. Only conversations that fall under the scope of CCM services would be included towards the time requirement.

    We noted that for billing under the PFS, the care coordination included in services such as office visits do not always describe adequately the non-face-to-face care management work involved in primary care. We also noted that payment for office visits may not reflect all the services and resources required to furnish comprehensive, coordinated care management for certain categories of beneficiaries, such as those who are returning to a community setting following discharge from a hospital or SNF stay. In considering CCM payment for RHCs and FQHCs, we believe that the non-face-to-face time required to coordinate care is also not captured in the RHC AIR or the FQHC PPS payment, particularly for the rural and/or low-income populations served by RHCs and FQHCs. Allowing separate payment for CCM services in RHCs and FQHCs is intended to reflect the additional resources necessary for the unique services that are required in order to furnish CCM services that are not already captured in the RHC AIR or the FQHC PPS payment.

    We propose that payment for CCM services be based on the PFS national average non-facility payment rate when CPT code 99490 is billed alone or with other payable services on a RHC or FQHC claim. (For the first quarter of 2015, the national average payment rate is $42.91 per beneficiary per calendar month.) CCM payment to RHCs and FQHCs would be based on the PFS amount, but would be paid as part of the RHC and FQHC benefit, using the CPT code to identify that the requirements for payment are met and a separate payment should be made. We also propose to waive the RHC and FQHC face-to-face requirements when CCM services are furnished to a RHC or FQHC patient. Coinsurance would be applied as applicable to FQHC claims, and coinsurance and deductibles would apply as applicable to RHC claims. RHCs and FQHCs would continue to be required to meet the RHC and FQHC Conditions of Participation and any additional RHC or FQHC payment requirements. We intend to provide detailed billing instructions in subregulatory guidance following publication of a final rule.

    b. Other Options Considered

    We considered adding CCM services as a RHC or FQHC covered stand-

    alone service and removing the RHC/FQHC policy requiring a face-to-face visit requirement for this service. Under this option, payment for RHCs would be at the AIR, payment for FQHCs would be the lesser of total charges or the PPS rate, and if CCM services are furnished on the same day as another payable medical visit, only one visit would be paid. We are not proposing this payment option because it would result in a significant overpayment if no other services were furnished on the same day, and would result in no additional payment if furnished on the same day as another medical visit.

    We also considered allowing RHCs and FQHCs to carve out CCM services and bill them separately to the PFS. We are not proposing this payment option because CCM services are a RHC and FQHC service and only non-RHC/FQHC services can be billed through the PFS.

    We also considered developing a modifier that could be added to the claim for additional payment when CCM services are furnished. We are not proposing this option because it would require that payment for CCM services be made only when furnished along with a billable service that qualifies as an RHC or FQHC service.

    We also considered establishing payment for CCM costs on a reasonable cost basis though the cost report. We are not proposing this option because payment for CCM services through the cost report would complicate coinsurance and/or deductible accountability, whereas it is more administratively feasible to apply coinsurance and/or deductible on a RHC/FQHC claim, as applicable. For example, section 1833(a)(3) of the Act specifies that influenza and pneumococcal vaccines and their administration are exempt from payment at 80 percent of reasonable costs and payment to RHCs and FQHCs for such services is at 100 percent of reasonable cost. Since influenza and pneumococcal vaccines and their administration are not subject to copayment, it is administratively feasible to pay these services through the cost report.

    3. Proposed Requirements for CCM Payment in RHCs and FQHCs

    a. Proposed Beneficiary Eligibility for CCM Services

    Consistent with beneficiary eligibility requirements under the PFS, we propose that RHCs and FQHCs receive payment for furnishing CCM services to patients with multiple chronic conditions that are expected to survive at least 12 months or until the death of the patient, and that place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline. RHCs and FQHCs are encouraged to focus on patients with high acuity and high risk when furnishing CCM services to eligible patients, including those who are returning to a community setting following discharge from a hospital or SNF.

    b. Proposed Beneficiary Agreement Requirements

    Not all patients who are eligible for separately payable CCM services may necessarily want these services to be provided, and some patients who receive CCM services may wish to discontinue them. A beneficiary who declines to receive CCM services from the RHC or FQHC, or who accepts the services and then chooses to revoke his/her agreement, would continue to be able to receive care from the RHC or FQHC and receive any care management services that are currently being furnished under the RHC AIR or FQHC PPS payment system.

    Consistent with beneficiary notification and consent requirements under the PFS, we propose that the following requirements be met before the RHC or FQHC can furnish or bill for CCM services:

    The eligible beneficiary must be informed about the availability of CCM services from the RHC or FQHC and provide his or her written agreement to have the services provided, including the electronic communication of the patient's information with other treating providers as part of care coordination. This would include a discussion with the patient about what CCM services are, how they differ from any care management services the RHC or FQHC currently offers, how these services are accessed, how the patient's information will be shared among others, that a non RHC or FQHC cannot furnish or bill for CCM services during the same calendar month that the RHC or FQHC furnishes CCM services, the applicability of coinsurance even when CCM services are not delivered face-to-face in the RHC or FQHC, and that any care management services that are currently provided will continue even if the patient does not agree to have CCM services provided.

    The RHC or FQHC must document in the patient's medical record that all of the CCM services were explained and offered to the patient, and note the patient's decision to accept these services.

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    At the time the agreement is obtained, the eligible beneficiary must be informed that the agreement for CCM services could be revoked by the beneficiary at any time either verbally or in writing, and the RHC or FQHC practitioner must explain the effect of a revocation of the agreement for CCM services. If the revocation occurs during a CCM 30-day period, the revocation would be effective at the end of that period. The eligible beneficiary must also be informed that the RHC or FQHC is able to be separately paid for these services during the 30-day period only if no other practitioner or eligible entity, including another RHC or FQHC that is not part of the RHC's or FQHC's organization, has already billed for this service. Since only one CCM payment can be paid per beneficiary per month, the RHC or FQHC would need to ask the patient if they are already receiving CCM services from another practitioner. Revocation by the beneficiary of the agreement must also be noted by recording the date of the revocation in the beneficiary's medical record and by providing the beneficiary with written confirmation that the RHC or FQHC would not be providing CCM services beyond the current 30-day period. A beneficiary who has revoked the agreement for CCM services from a RHC or FQHC may choose instead to receive these services from a different practitioner (including another RHC or FQHC), beginning at the conclusion of the 30-

    day period.

    The RHC or FQHC must provide a written or electronic copy of the care plan to the beneficiary and record this in the beneficiary's electronic medical record.

    c. Proposed Scope of CCM Services in RHCs and FQHCs

    We propose that all of the following scope of service requirements must be met to bill for CCM services:

    Initiation of CCM services during a comprehensive Evaluation/Management (E/M), AWV, or IPPE visit. The time spent furnishing these services would not be included in the 20 minute monthly minimum required for CCM billing.

    Continuity of care with a designated RHC or FQHC practitioner with whom the patient is able to get successive routine appointments.

    Care management for chronic conditions, including systematic assessment of a patient's medical, functional, and psychosocial needs; system-based approaches to ensure timely receipt of all recommended preventive care services; medication reconciliation with review of adherence and potential interactions; and oversight of patient self-management of medications.

    A patient-centered plan of care document created by the RHC or FQHC practitioner furnishing CCM services in consultation with the patient, caregiver, and other key practitioners treating the patient to assure that care is provided in a way that is congruent with patient choices and values. The plan would be a comprehensive plan of care for all health issues based on a physical, mental, cognitive, psychosocial, functional and environmental (re)assessment and an inventory of resources and supports. It would typically include, but not be limited to, the following elements: problem list, expected outcome and prognosis, measurable treatment goals, symptom management, planned interventions, medication management, community/social services ordered, how the services of agencies and specialists unconnected to the practice will be directed/coordinated, the individuals responsible for each intervention, requirements for periodic review and, when applicable, revision, of the care plan. A complete list of problems, medications, and medication allergies would be in the electronic health record to inform the care plan, care coordination, and ongoing clinical care.

    Creation of an electronic care plan that would be available 24 hours a day and 7 days a week to all practitioners within the RHC or FQHC who are furnishing CCM services whose time counts towards the time requirement for billing the CCM code, and to other practitioners and providers, as appropriate, who are furnishing care to the beneficiary, to address a patient's urgent chronic care needs. No specific electronic solution or format is required to meet this scope of service element. However, we encourage RHCs and FQHCs who wish to learn more about currently available electronic standards for care planning to refer to the proposed rulemaking for the 2015 Edition of Health Information Technology Certification Criteria, which includes a proposal to enable users of certified health IT to create and receive care plan information in accordance with the C-CDA Release 2.0 standard (80 FR 16842).

    Management of care transitions within health care including referrals to other clinicians, visits following a patient visit to an emergency department, and visits following discharges from hospitals and SNFs. The RHC or FQHC must be able to facilitate communication of relevant patient information through electronic exchange of a summary care record with other health care providers regarding these transitions. The RHC or FQHC must also have qualified personnel who are available to deliver transitional care services to a patient in a timely way to reduce the need for repeat visits to emergency departments and readmissions to hospitals and SNFs.

    Coordination with home and community based clinical service providers required to support a patient's psychosocial needs and functional deficits. Communication to and from home and community based providers regarding these clinical patient needs must be documented in the RHC's or FQHC's medical record system.

    Secure messaging, internet or other asynchronous non-face-

    to-face consultation methods for a patient and caregiver to communicate with the provider regarding the patient's care in addition to the use of the telephone. We would note that the faxing of information would not meet this requirement. These methods would be required to be available, but would not be required to be used by every practitioner or for every patient receiving CCM services.

    d. Proposed Electronic Health Records (EHR) Requirements

    We believe that the use of EHR technology that allows data sharing is necessary to assure that RHCs and FQHCs can effectively coordinate services with other practitioners for patients with multiple chronic conditions. Therefore, we propose the following requirements:

    Certified health IT must be used for the recording of demographic information, health-related problems, medications, and medication allergies; a clinical summary record; and other scope of service requirements that reference a health or medical record.

    RHCs and FQHCs must use technology certified to the edition(s) of certification criteria that is, at a minimum, acceptable for the EHR Incentive Programs as of December 31st of the year preceding each CCM payment year to meet the following core technology capabilities: structured recording of demographics, problems, medications, medication allergies, and the creation of a structured clinical summary. For example, technology used to furnish CCM services beginning on January 1, 2016, would be required to meet, at a minimum, the requirements included in the 2014 Edition certification criteria. For the purposes of the scope of services, we refer to technology meeting these requirements as ``CCM Certified Technology.''

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    Applicable HIPAA standards would apply to electronic sharing of patient information.

    Table 17--Summary of Proposed CCM Scope of Service Elements and Billing

    Requirements

    ------------------------------------------------------------------------

    CCM Scope of service/billing

    requirements Health IT requirements

    ------------------------------------------------------------------------

    Initiation of CCM services at an AWV, None.

    IPPE, or a comprehensive E/M visi.

    Structured recording of demographics, Structured recording of

    problems, medications, medication demographics, problems,

    allergies, and the creation of a medications, medication

    structured clinical summary record. A allergies, and creation of

    full list of problems, medications and structured clinical summary

    medication allergies in the EHR must records using CCM certified

    inform the care plan, care technology.

    coordination, and ongoing clinical

    care.

    Access to CCM services 24/7 (providing None.

    the beneficiary with a means to make

    timely contact with the RHC or FQHC to

    address his or her urgent chronic care

    needs regardless of the time of day or

    day of the week.

    Continuity of care with a designated None.

    RHC or FQHC practitioner with whom the

    beneficiary is able to get successive

    routine appointment.

    CCM services for chronic conditions None.

    including systematic assessment of the

    beneficiary's medical, functional, and

    psychosocial needs; system-based

    approaches to ensure timely receipt of

    all recommended preventive care

    services; medication reconciliation

    with review of adherence and potential

    interactions; and oversight of

    beneficiary self-management of

    medication.

    Creation of a patient-centered care Must at least electronically

    plan based on a physical, mental, capture care plan information;

    cognitive, psychosocial, functional make this information

    and environmental (re)assessment and available on a 24/7 basis to

    an inventory of resources and all practitioners within the

    supports; a comprehensive care plan RHC or FQHC whose time counts

    for all health issues. Share the care towards the time requirement

    plan as appropriate with other for the practice to bill for

    practitioners and providers. CCM services; and share care

    plan information

    electronically (other than by

    fax) as appropriate with other

    practitioners, providers, and

    caregivers.

    Provide the beneficiary with a written Document provision of the care

    or electronic copy of the care plan plan as required to the

    and document its provision in the beneficiary in the EHR using

    electronic medical record. CCM certified technology.

    Management of care transitions between Format clinical summaries

    and among health care providers and according to CCM certified

    settings, including referrals to other technology. Not required to

    clinicians; follow-up after an use a specific tool or service

    emergency department visit; and follow- to exchange/transmit clinical

    up after discharges from hospitals, summaries, as long as they are

    skilled nursing facilities or other transmitted electronically

    health care facilities. (other than by fax).

    Coordination with home and community Communication to and from home

    based clinical service providers. and community based providers

    regarding the patient's

    psychosocial needs and

    functional deficits must be

    documented in the patient's

    medical record using CCM

    certified technology.

    Enhanced opportunities for the None.

    beneficiary and any caregiver to

    communicate with the RHC or FQHC

    regarding the beneficiary's care

    through not only telephone access, but

    also through the use of secure

    messaging, internet or other

    asynchronous non face-to-face

    consultation methods.

    Beneficiary consent--Inform the ...............................

    beneficiary of the availability of CCM

    services and obtain his or her written

    agreement to have the services

    provided, including authorization for

    the electronic communication of his or

    her medical information with other

    treating providers.

    Document in the beneficiary's medical ...............................

    record that all of the CCM services

    were explained and offered, and note

    the beneficiary's decision to accept

    or decline these services.

    Document the beneficiary's written Document the beneficiary's

    consent and authorization in the EHR written consent and

    using CCM certified technology. authorization in the EHR using

    CCM certified technology.

    Beneficiary consent--Inform the None.

    beneficiary of the right to stop the

    CCM services at any time (effective at

    the end of the calendar month) and the

    effect of a revocation of the

    agreement on CCM services.

    Beneficiary consent--Inform the None.

    beneficiary that only one practitioner

    can furnish and be paid for these

    services during a calendar month.

    ------------------------------------------------------------------------

    We invite public comments on all aspects of the proposed payment methodology and billing for CCM services in RHCs and FQHCs, the proposed CCM requirements for RHCs and FQHCs, and any other aspect of our proposal.

  42. Healthcare Common Procedure Coding System (HCPCS) Coding for Rural Health Clinics (RHCs)

    1. RHC Payment Methodology and Billing Requirements

    RHCs are paid an all-inclusive rate (AIR) per visit for medically necessary primary health services and qualified preventive health services furnished face-to-face by a RHC practitioner to a Medicare beneficiary. The all-inclusive payment system was designed to minimize reporting requirements, and as such, the rate includes all costs associated with the services that a RHC furnishes in a single day to a Medicare

    Page 41798

    beneficiary, regardless of the length or complexity of the visit or the number or type of RHC practitioners seen. Except for certain preventive services that are not subject to coinsurance requirements, it has not been necessary for RHCs to submit reporting of medical and procedure codes, such as level I and level II of the HCPCS, on claims for services that were furnished during the visit to determine Medicare payment. Generally, the services reported using the appropriate site of service revenue code on a RHC claim receives payment under the AIR, with coinsurance and deductible applied based upon the associated charges on that line, notwithstanding other Medicare requirements.

    Historically, billing instructions for RHCs and Federally Qualified Health Centers (FQHCs) have been similar. Beginning on April 1, 2005, through December 31, 2010, RHCs and FQHCs were no longer required to report HCPCS when billing for RHC and FQHC services rendered during an encounter, absent a few exceptions. CMS Transmittal 371, dated November 19, 2004, eliminated HCPCS coding for FQHCs and eliminated the additional line item reporting of preventive services for RHCs and FQHCs for claims with dates of service on or after April 1, 2005. CMS Transmittal 1719, dated April 24, 2009, effective October 1, 2009, required RHCs and FQHCs to report HCPCS codes for a few services, such as certain preventive services eligible for a waiver of deductible, services subject to frequency limits, and services eligible for payments in addition to the all-inclusive rate.

    Section 1834(o)(1)(B) of the Act, as added by the Affordable Care Act, required that FQHCs begin reporting services using HCPCS codes to develop and implement the FQHC PPS. Since January 1, 2011, FQHCs have been required to report all services furnished during an encounter by specifically listing the appropriate HCPCS code(s) for each line item, along with the site of service revenue code(s), when billing Medicare. As of October 1, 2014, HCPCS coding is used to calculate payment for FQHCs that are paid under the FQHC PPS.

    Section 4104 of the Affordable Care Act waived the coinsurance and deductible for the initial preventive physical examination (IPPE), the annual wellness visit (AWV), and other Medicare covered preventive services recommended by the United States Preventive Services Task Force (USPSTF) with a grade of A or B. Since January 1, 2011, HCPCS coding has been required for these preventive services when reported by RHCs. When billing for an approved preventive service, RHCs must report an additional line with the appropriate site of service revenue code with the approved preventive service HCPCS code and the associated charges. Although HCPCS coding is currently required for approved preventive services on RHC claims, HCPCS coding is not used to determine RHC payment.

    2. Proposed Requirement for Reporting of HCPCS Coding for All Services Furnished by RHCs During a Medicare Visit

    For payment under Medicare Part B, the statute requires health transactions to be exchanged electronically, subject to certain exceptions, using standards specified by the Secretary. Specifically, section 1862(a)(22) of the Act requires that no payment may be made under part A or part B for any expenses incurred for items or services, subject to exceptions under section 1862(h), for which a claim is submitted other than in an electronic form specified by the Secretary. Further, section 1173 of the Act, added by section 262 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), requires the Secretary to adopt standards for transactions, and data elements for such transactions, to enable health information to be exchanged electronically, that are appropriate for transactions. These include but are not limited to health claims or equivalent encounter information. As a result of the HIPAA amendments, HHS adopted regulations pertaining to data standards for health care related transactions. The regulations at 45 CFR 160.103 define a covered entity to include a provider of medical or health services (as defined in section 1861(s) of the Act), and define the types of standard transactions. When conducting a transaction, under 45 CFR 162.1000, a covered entity must use the applicable medical data code sets described in Sec. 162.1002 that are valid at the time the health care is furnished, and these regulations define the standard medical data code sets adopted by the Secretary as HCPCS and CPT (Current Procedural Terminology- Fourth Edition) for physician services and other health care services.

    Under section 1861(s)(2)(E) of the Act, a RHC is a supplier of ``medical or health services.'' As such, our regulations require these covered entities to report a standard medical code set for electronic health care transactions, although our program instructions have directed RHCs to submit HCPCS codes only for preventive services. We believe reporting of HCPCS coding for all services furnished by a RHC would be consistent with the health transactions requirements, and would provide useful information on RHC patient characteristics, such as level of acuity and frequency of services furnished, and the types of services being furnished by RHCs. This information would also allow greater oversight of the program and inform policy decisions.

    We propose that all RHCs must report all services furnished during an encounter using standardized coding systems, such as level I and level II of the HCPCS, for dates of service on or after January 1, 2016. In accordance with section 1862(h) of the Act, in limited situations RHCs that are unable to submit electronic claims and RHCs with fewer than 10 full time equivalent employees are exempt from submitting claims electronically. We propose that RHCs exempt from electronic reporting under 1862(h) of the Act must also report all services furnished during an encounter using HCPCS coding via paper claims for dates of services on or after January 1, 2016. This proposal would necessitate new billing practices for such RHCs, but we believe there would be no significant burden for the limited number of RHCs exempt from electronic billing.

    Under this proposal, a HCPCS code would be reported along with the presently required Medicare revenue code for each service furnished by the RHC to a Medicare patient. Although HCPCS coding is currently used to determine FQHC payment under the FQHC PPS, under this proposal, RHCs would continue to be paid under the AIR and there would be no change in their payment methodology.

    Accordingly, we are proposing to remove the requirement at Sec. 405.2467(b) pertaining to HCPCS coding for FQHCs and redesignate paragraphs (c) and (d) as paragraphs (b) and (c), respectively. We are also proposing to add a new paragraph (g)(3) to Sec. 405.2462 to require FQHCs and RHCs, whether or not exempt from electronic reporting under Sec. 424.32(d)(3), to report on Medicare claims all service(s) furnished during each FQHC and RHC visit (as defined in Sec. 405.2463) using HCPCS and other codes as required.

    We propose to require reporting of HCPCS coding for all services furnished by RHCs to Medicare beneficiaries effective for dates of service on or after January 1, 2016. We are aware that many RHCs already record this information through their billing software or electronic health record systems; however, we recognize there may be some RHCs that need to make

    Page 41799

    changes in their systems. We invite RHCs to submit comments on the feasibility of updating their billing systems to meet this implementation date of January 1, 2016.

    As part of the implementation of the HCPCS coding requirement, we plan to provide instructions on how RHCs are to report HCPCS and other coding and clarify other appropriate billing procedures through program instruction. CMS' Medicare claims processing system would be revised to accept the addition of the new RHC reporting requirements effective January 1, 2016.

  43. Payment to Grandfathered Tribal FQHCs That Were Provider-Based Clinics on or Before April 7, 2000

    1. Background

    a. Health Services to American Indians and Alaskan Natives (AI/AN)

    There is a special government-to-government relationship between the federal government and federally recognized tribes based on U.S. treaties, laws, Supreme Court decisions, Executive Orders and the U.S. Constitution. This government-to-government relationship forms the basis for federal health services to American Indians/Alaska Natives (AI/AN) in the U.S.

    In 1976, the Indian Health Care Improvement Act (IHCIA, P.L. 94-

    437) amended the statute to permit payment by Medicare and Medicaid for services provided to AI/ANs in Indian Health Service (IHS) and tribal health care facilities that meet the applicable requirements. Under this authority, Medicare services to AI/ANs may be furnished by IHS operated facilities and programs and tribally-operated facilities and programs under Title I or Title V of the Indian Self Determination Education Assistance Act, as amended (ISDEAA, P.L 93-638).

    According to the IHS Year 2015 Profile, the IHS healthcare delivery system currently consists of 46 hospitals, with 28 of those hospitals operated by the IHS and 18 of them operated by tribes under the ISDEAA.

    Payment rates for inpatient and outpatient medical care furnished by the IHS and tribal facilities is set annually by the IHS under the authority of sections 321(a) and 322(b) of the Public Health Service (PHS) Act (42 U.S.C. 248 and 249(b)), Public Law 83-568 (42 U.S.C. 2001(a)), and the Indian Health Care Improvement Act (IHCIA) (25 U.S.C. 1601 et seq.), based on the previous year's cost reports from federal and tribal hospitals. The 1976 IHCIA provided the authority for CMS (then HCFA) to pay IHS for its hospital services to Medicare eligible patients, and in 1978 CMS agreed to use a Medicare all-inclusive payment rate for IHS hospitals and IHS hospital-based clinics.

    There is an outpatient visit rate for Medicare visits in Alaska and an outpatient visit rate for Medicare visits in the lower 48 States. The Medicare outpatient rate is only applicable for those IHS or tribal facilities that meet the definition of a provider-based department as described at Sec. 413.65(a), or a ``grandfathered'' facility as described at Sec. 413.65(m). For calendar year 2015, the Medicare outpatient encounter rate is $564 for Alaska and $307 for the rest of the country (80 FR 18639, April 7, 2015).

    b. Provider-Based Entities and the ``Grandfathering'' Provision

    In 2000, we adopted regulations at Sec. 413.65 that established criteria for facilities to be considered provider-based to a hospital for Medicare payment purposes. The provider-based rules apply to facilities located both on and off the main hospital campus for which provider-based status is sought.

    In the CY 2001 Hospital Outpatient PPS final rule with comment period (65 FR 18507), we addressed comments on the proposed provider-

    based rules. In regard to IHS facilities, commenters expressed concern that the proposed rule would undermine the ISDEAA contracting and compacting relationships between the IHS and tribes because provider-

    based clinics must be clinically and administratively integrated into the hospital, and a tribe that assumes the operation of a provider-

    based clinic but not the operation of the hospital would not be able to meet this requirement. They were also concerned that the proposed proximity requirements would threaten the status of many IHS and tribal facilities that frequently were located in distant remote areas.

    In response to these comments and the special provisions of law referenced above governing health care for IHS and the tribes, we recognized the special relationship between tribes and the United States government, and did not apply the general provider-based criteria to IHS and tribally-operated facilities. The regulations currently include a grandfathering provision at Sec. 413.65(m) for IHS and tribal facilities that were provider-based to a hospital on or prior to April 7, 2000. This section states that facilities and organizations operated by the IHS or tribes will be considered to be departments of hospitals operated by the IHS or tribes if, on or before April 7, 2000, they furnished only services that were billed as if they had been furnished by a department of a hospital operated by the IHS or a tribe and they are:

    Owned and operated by the IHS;

    Owned by the tribe but leased from the tribe by the IHS under the ISDEAA in accordance with applicable regulations and policies of the IHS in consultation with tribes; or

    Owned by the IHS but leased and operated by the tribe under the ISDEAA in accordance with applicable regulations and policies of the IHS in consultation with tribes.

    Under the authority of the ISDEAA, a tribe may assume control of an IHS hospital and the provider-based clinics affiliated with the hospital, or may only assume responsibility of the provider-based clinic. On August 11, 2003, we issued a letter to Trailblazer Health Enterprises, LLC, stating that changes in the status of a hospital or facility from IHS to tribal operation, or vice versa, or the realignment of a facility from one IHS or tribal hospital to another IHS or tribal hospital, would not affect the facility's grandfathered status if the resulting configuration is one which would have qualified for grandfathering under Sec. 413.65(m) if it had been in effect on April 7, 2000.

    The Medicare Conditions of Participation (CoPs) for Medicare-

    participating hospitals at Sec. 482.12 require administrative and clinical integration between a hospital and its clinics, departments, and provider-based entities. A tribal clinic billing under an IHS hospital's CMS Certification Number (CCN), without any additional administrative or clinical relationship with the IHS hospital, could put that hospital at risk for non-compliance with the CoPs.

    Consequently, we believe that a different structure is needed to maintain access to care for AI/AN populations served by these hospitals and clinics, while also ensuring that these facilities are in compliance with our health and safety rules. The FQHC program may provide an alternative structure that meets the needs of these tribal clinics and the populations they serve, while also ensuring the IHS hospitals are not at risk for non-compliance with the requirements in Sec. 482.12.

    c. Federally Qualified Health Centers (FQHCs)

    FQHCs were established in 1990 by section 4161 of the Omnibus Budget Reconciliation Act of 1990 and were effective beginning on October 1, 1991. They are facilities that furnish services

    Page 41800

    that are typically furnished in an outpatient clinic setting.

    The statutory requirements that FQHCs must meet to qualify for the Medicare benefit are in section 1861(aa)(4) of the Act. All FQHCs are subject to Medicare regulations at 42 CFR part 405, subpart X, and 42 CFR part 491. Based on these provisions, the following three types of organizations that are eligible to enroll in Medicare as FQHCs:

    Health Center Program grantees: Organizations receiving grants under section 330 of the PHS Act (42 U.S.C. 254b).

    Health Center Program ``look-alikes'': Organizations that have been identified by the Health Resources and Services Administration as meeting the requirements to receive a grant under section 330 of the PHS Act, but which do not receive section 330 grant funding.

    Outpatient health programs or facilities operated by a tribe or tribal organization under the ISDEAA, or by an urban Indian organization receiving funds under Title V of the IHCIA.

    FQHCs are also entities that were treated by the Secretary for purposes of Medicare Part B as a comprehensive federally funded health center as of January 1, 1990 (see section 1861(aa)(4)(C) of the Act).

    Section 1834 of the Act was amended by section 10501(i)(3)(A) of the Affordable Care Act by adding a new subsection (o), ``Development and Implementation of Prospective Payment System''. Section 1834(o)(1)(A) of the Act requires that the system include a process for appropriately describing the services furnished by FQHCs, and establish payment rates based on such descriptions of services, taking into account the type, intensity, and duration of services furnished by FQHCs. It also stated that the new system may include adjustments (such as geographic adjustments) as determined appropriate by the Secretary.

    Section 1833(a)(1)(Z) was added by the Affordable Care Act to require that Medicare payment for FQHC services under section 1834(o) of the Act shall be 80 percent of the lesser of the actual charge or the PPS amount determined under section 1834(o) of the Act.

    In accordance with the requirements in the Affordable Care Act, beginning on October 1, 2014, payment to FQHCs is based on the lesser of the national encounter-based FQHC PPS rate, or the FQHC's total charges, for primary health services and qualified preventive health services furnished to Medicare beneficiaries. The FQHC PPS rate is adjusted by the FQHC geographic adjustment factor (GAF), which is based on the Geographic Practice Cost Index used under the PFS. The FQHC PPS rate is also adjusted when the FQHC furnishes services to a patient that is new to the FQHC, and when the FQHC furnishes an IPPE or an AWV. The FQHC PPS base rate for the period from October 1, 2014 to December 31, 2015 is $158.85. The rate will be adjusted in calendar year 2016 by the Medicare Economic Index (MEI), as defined at section 1842(i)(3) of the Act, and subsequently by either the MEI or a FQHC market basket (which would be determined pursuant to CMS regulations).

    To assure that FQHCs receive appropriate payment for services furnished, we established a new set of five HCPCS G-codes for FQHCs to report Medicare visits. These G-codes include all the services in a typical bundle of services that would be furnished per diem to a Medicare patient at the FQHC. The five FQHC G-codes are:

    G0466-FQHC visit, new patient

    G0467-FQHC visit, established patient

    G0468-FQHC visit, IPPE or AWV

    G0469-FQHC visit, mental health, new patient

    G0470-FQHC visit, mental health, established patient

    FQHCs establish charges for the services they furnish to FQHC patients, including Medicare beneficiaries, and charges must be uniform for all patients, regardless of insurance status. The FQHC would determine the services that are included in each of the 5 FQHC G-codes, and the sum of the charges for each of the services associated with the G-code would be the G-code payment amount. Payment to the FQHC for a Medicare visit is the lesser of the FQHC's charges (as established by the G-code), or the PPS rate.

    2. Proposed Payment Methodology and Requirements

    We are proposing that IHS and tribal facilities and organizations that met the conditions of section 413.65(m) on or before April 7, 2000, and have a change in their status on or after April 7, 2000 from IHS to tribal operation, or vice versa, or the realignment of a facility from one IHS or tribal hospital to another IHS or tribal hospital such that the organization no longer meets the CoPs, may seek to become certified as grandfathered tribal FQHCs. To help avoid any confusion, we refer to these tribal FQHCs as grandfathered tribal FQHCs to distinguish them from freestanding tribal FQHCs that are currently being paid the lesser of their charges or the adjusted national FQHC PPS rate of $158.85, and from provider-based tribal clinics that may have begun operations subsequent to April 7, 2000.

    Under the authority in 1834(o) of the Affordable Care Act to ``include adjustments . . . determined appropriate by the Secretary,'' we are proposing that these grandfathered tribal FQHCs be paid the lesser of their charges or a grandfathered tribal FQHC PPS rate of $307, which equals the Medicare outpatient per visit payment rate paid to them as a provider-based department, as set annually by the IHS, rather than the FQHC PPS per visit base rate of $158.85, and that coinsurance would be 20 percent of the lesser of the actual charge or the grandfathered tribal FQHC PPS rate. These grandfathered tribal FQHCs would be required to meet all FQHC certification and payment requirements. This FQHC PPS adjustment for grandfathered tribal clinics would not apply to a currently certified tribal FQHC, a tribal clinic that was not provider-based as of April 7, 2000, or an IHS-operated clinic that is no longer provider-based to a tribally-operated hospital. This provision would also not apply in those instances where both the hospital and its provider-based clinic(s) are operated by the tribe or tribal organization.

    Since we are proposing that these grandfathered tribal FQHCs would be paid based on the IHS payment rates and not the FQHC PPS payment rates, we are also proposing that the payment rate would not be adjusted by the FQHC PPS GAF, or be eligible for the special payment adjustments under the FQHC PPS for new patients, patients receiving an IPPE or an AWV. They would also not be eligible for the exceptions to the single per diem payment that is available to FQHCs paid under the FQHC PPS. As the IHS outpatient rate for Medicare is set annually, we also propose not to apply the MEI or a FQHC market basket adjustment that is applied annually to the FQHC PPS base rate. We are proposing that these adjustments not be applied because we believe that the special status of these grandfathered tribal clinics, and the enhanced payment they would receive under the FQHC PPS system, would make further adjustments unnecessary and/or duplicative of adjustments already made by IHS in deriving the rate. While we are proposing in this proposed rule an adjustment to the FQHC PPS rate to reflect the IHS rate for these grandfathered tribal clinics, if adopted as final, we will monitor future costs and claims data of these tribal clinics and reconsider options as appropriate.

    Page 41801

    Grandfathered tribal FQHCs would be paid for services included in the FQHC benefit, even if those services are not included in the IHS Medicare outpatient all-inclusive rate. Services that are included in the IHS outpatient all-inclusive rate but not in the FQHC benefit would not be paid. Information on the FQHC benefit is available in Chapter 13 of the Medicare Benefit Policy Manual.

    Grandfathered tribal FQHCs will be subject to Medicare regulations at part 405, subpart X, and part 491, except as noted in section III.D.2. of this proposed rule.

    We therefore propose to revise Sec. 405.2462, Sec. 405.2463, Sec. 405.2464, and Sec. 405.2469 to specify the requirements for payment as a grandfathered tribal FQHC, and to specify payment provisions, adjustments, rates, and other requirements for grandfathered tribal FQHCs.

    3. Transition

    To become certified as a FQHC, an eligible tribe or tribal organization must submit a Form 855A and all required accompanied documentation, including an attestation of compliance with the Medicare FQHC Conditions for Coverage at part 491, to the Jurisdiction H Medicare Administrative Contractor (A/B MAC). After reviewing the application and determining that it is complete and approvable, the MAC would forward the application with its recommendation for approval to the CMS Regional Office (RO) that has responsibility for the geographic area in which the tribal clinic is located. The RO would issue a Medicare FQHC participation agreement to the tribal FQHC, including a CMS Certification Number (CCN), and would advise the MAC of the CCN number, to facilitate the MAC's processing of FQHC claims submitted by the tribal FQHC. Payment to grandfathered tribal FQHCs would begin on the first day of the month in the first quarter of the year subsequent to receipt of a Medicare CCN.

    4. Conforming Changes

    In addition, to the changes proposed in Sec. 405.2462, Sec. 405.2463, Sec. 405.2464, and Sec. 405.2469, we are proposing to: remove obsolete language from Sec. 405.2410 regarding FQHCs that bill on the basis of the reasonable cost system, add a section heading to Sec. 405.2415, and remove obsolete language from Sec. 405.2448 regarding employment requirements.

  44. Part B Drugs

    1. Payment for Biosimilar Biological Products Under Section 1847A

    Section 3139 of the Affordable Care Act amended section 1847A of the Act to define a biosimilar biological product and a reference biological product, and to provide for Medicare payment of biosimilar biological products using the average sale price (ASP) methodology.

    Section 1847A(c)(6)(H) of the Act, as added by section 3139 of the Affordable Care Act, defines a biosimilar biological product as a biological product approved under an abbreviated application for a license of a biological product that relies in part on data or information in an application for another biological product licensed under section 351 of the Public Health Service Act (PHSA). Section 1847A(c)(6)(I) of the Act, as added by section 3139 of the Affordable Care Act, defines the reference biological product for a biosimilar biological product as the biological product licensed under such section 351 of the PHSA that is referred to in the application of the biosimilar biological product.

    Section 3139 of the Affordable Care Act also amended section 1847A(b) of the Act by adding a new paragraph (8) to specify that the payment amount for a biosimilar biological product will be the sum of the following two amounts: the ASP as determined using the methodology described under paragraph 1847A(b)(6) applied to a biosimilar biological product for all National Drug Codes (NDCs) assigned to such product in the same manner as such paragraph is applied to drugs described in such paragraph; and 6 percent of the payment amount determined using the methodology in section 1847A(b)(4) of the Act for the corresponding reference biological product. The effective date for ASP statutory provisions on biosimilars was July 1, 2010. Separate sections of the Affordable Care Act also established a licensing pathway for biosimilar biological products.

    To implement these provisions, we published CY 2011 PFS final rule with comment period (75 FR 73393 and 73394) in the Federal Register on November 29, 2010. The relevant regulation text is found at Sec. 414.902 and Sec. 414.904. At the time that the CY 2011 PFS final rule with comment period was published, it was not apparent how or when the new FDA abbreviated approval pathway would be implemented or when biosimilar products would be approved for marketing in the United States. The FDA approved the first biosimilar product under the new biosimilar approval pathway required by the Affordable Care Act on March 6, 2015.

    Since 2010, we have continued to follow the implementation of the FDA biosimilar approval process and the emerging biosimilar marketplace. As biosimilars are now beginning to enter the marketplace, we have also reviewed the existing guidance on Medicare payment for these products. Our review has revealed a potential inconsistency between our interpretation of the statutory language at section 1847A(b)(8) of the Act and regulation text at Sec. 414.904(j). To make the regulation text more consistent with our interpretation of the statutory language, we are proposing to amend the regulation text at Sec. 414.904(j) to make clear that the payment amount for a biosimilar biological product is based on the ASP of all NDCs assigned to the biosimilar biological products included within the same billing and payment code. We are also proposing to amend the regulation text at Sec. 414.914(j) to update the effective date of this provision from July 1, 2010 to January 1, 2016, the anticipated effective date of the CY 2016 Physician Fee Schedule Final Rule with Comment Period. We welcome comments about these proposals.

    We would also like to take this opportunity to discuss and clarify some other details of Part B biosimilar payment policy. First, we plan to use a single ASP payment limit for biosimilar products that are assigned to a specific HCPCS code. In general, this means that products that rely on a common reference product's biologics license application will be grouped into the same payment calculation. This approach, which is similar to the ASP calculation for multiple source drugs, is authorized by section 1847A(b)(8)(A) of the Act, which states that the payment determination for a biosimilar biological product is determined using the methodology in paragraph 1847A(b)(6) applied to a biosimilar biological product for all NDCs assigned to such product in the same manner as such paragraph is applied to drugs described in such paragraph.

    Second, we would like to describe how payment for newly approved biosimilars will be determined. As we stated in the CY 2011 PFS final rule with comment period (75 FR 73393 and 73394), we anticipate that as subsequent biosimilar biological products are approved, we will receive manufacturers' ASP sales data through the ASP data submission process and publish national payment amounts in a manner that is consistent with our current approach to other drugs and

    Page 41802

    biologicals that are paid under section 1847A of the Act and set forth in 42 CFR part 414 subpart J. Until we have collected sufficient sales data as reported by manufacturers, payment limits will be determined in accordance with the provisions in section 1847A(c)(4) of the Act. If no manufacturer data is collected, prices will be determined by local contractors using any available pricing information, including provider invoices. As with newly approved drugs and biologicals (including biosimilars), Medicare part B payment would be available once the product is approved by the FDA. Payment for biosimilars (and other drugs and biologicals that are paid under part B) may be made before a HCPCS code has been released, provided that the claim is reasonable and necessary, and meets applicable coverage and claims submission criteria.

    We would also like to clarify how wholesale acquisition cost (WAC) data may be used by CMS for Medicare payment of biosimilars in accordance with the provisions in section 1847A(c)(4) of the Act. Section 1847A(c)(4) of the Act authorizes the use of a WAC-based payment amount in cases where the ASP during the first quarter of sales is not sufficiently available from the manufacturer to compute an ASP-

    based payment amount. Once the wholesale acquisition cost (WAC) data is available from the pharmaceutical pricing compendia and when WAC-based payment amounts are utilized by CMS to determine the national payment limit for a biosimilar product, the payment limit will be 106 percent of the WAC of the biosimilar product; the reference biological product will not be factored into the WAC-based payment limit determination. This approach is consistent with partial quarter pricing that was discussed in rulemaking in the CY 2011 PFS final rule with comment period (75 FR 73465 and 73466) and with statutory language at section 1847A(c)(4) of the Act. Once ASP information is available for a biosimilar product, and when partial quarter pricing requirements no longer apply, the Medicare payment limit for a biosimilar product will be determined based on ASP data.

  45. Productivity Adjustment for the Ambulance, Clinical Laboratory, and DMEPOS Fee Schedules

    Section 3401 of the Affordable Care Act requires that the update factor under certain payment systems be annually adjusted by changes in economy-wide productivity. The year that the productivity adjustment is effective varies by payment system. Specifically, section 3401 of the Affordable Care Act requires that in CY 2011 (and in subsequent years) update factors under the ambulance fee schedule (AFS), the clinical laboratory fee schedule (CLFS) and the DMEPOS fee schedule be adjusted by changes in economy-wide productivity. Section 3401(a) of the Affordable Care Act amends section 1886(b)(3)(B) of the Act to add clause (xi)(II), which sets forth the definition of this productivity adjustment. The statute defines the productivity adjustment to be equal to the 10-year moving average of changes in annual economy-wide private nonfarm business multifactor productivity (MFP) (as projected by the Secretary for the 10-year period ending with the applicable fiscal year, year, cost reporting period, or other annual period). Historical published data on the measure of MFP is available on the Bureau of Labor Statistics (BLS) Web site at http://www.bls.gov/mfp.

    MFP is derived by subtracting the contribution of labor and capital inputs growth from output growth. The projection of the components of MFP are currently produced by IHS Global Insight, Inc. (IGI), a nationally recognized economic forecasting firm with which we contract to forecast the components of MFP. To generate a forecast of MFP, IGI replicates the MFP measure calculated by the BLS using a series of proxy variables derived from IGI's U.S. macroeconomic models. In the CY 2011 and CY 2012 PFS final rules with comment period (75 FR 73394 through 73396, 76 FR 73300 through 73301), we set forth the current methodology to generate a forecast of MFP. We identified each of the major MFP component series employed by the BLS to measure MFP as well as provided the corresponding concepts determined to be the best available proxies for the BLS series. Beginning with CY 2016, for the AFS, CLFS and DMEPOS fee schedule, the MFP adjustment is calculated using a revised series developed by IGI to proxy the aggregate capital inputs. Specifically, IGI has replaced the Real Effective Capital Stock used for Full Employment GDP with a forecast of BLS aggregate capital inputs recently developed by IGI using a regression model. This series provides a better fit to the BLS capital inputs, as measured by the differences between the actual BLS capital input growth rates and the estimated model growth rates over the historical time period. Therefore, we are using IGI's most recent forecast of the BLS capital inputs series in the MFP calculations beginning with CY 2016. A complete description of the MFP projection methodology is available on our Web site at http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MedicareProgramRatesStats/MarketBasketResearch.html. Although we discuss the IGI changes to the MFP proxy series in this proposed rule, in the future, when IGI makes changes to the MFP methodology, we will announce them on our Web site rather than in the annual rulemaking.

  46. Appropriate Use Criteria for Advanced Diagnostic Imaging Services

    Section 218(b) of the PAMA amended Title XVIII of the Act to add section 1834(q) directing us to establish a program to promote the use of appropriate use criteria (AUC) for advanced diagnostic imaging services. This proposed rule outlines the initial component of the new Medicare AUC program and our plan for implementing the remaining components.

    1. Background

    In general, AUC are a set of individual criteria that present information in a manner that links a specific clinical condition or presentation, one or more services, and an assessment of the appropriateness of the service(s). Evidence-based AUC for imaging can assist clinicians in selecting the imaging study that is most likely to improve health outcomes for patients based on their individual context.

    We believe the goal of this statutory AUC program is to promote the evidence-based use of advanced diagnostic imaging to improve quality of care and reduce inappropriate imaging. Professional medical societies, health systems, and academic institutions have been designing and implementing AUC for decades. Experience and published studies alike show that results are best when AUC are built on an evidence base that considers patient health outcomes, weighing the benefits and harms of alternative care options, and integrated into broader care management and continuous quality improvement (QI) programs. Successful QI programs in turn have provider-led multidisciplinary teams collectively identify key clinical processes and then develop bottom-up, evidence-

    based AUC or guidelines that are embedded into clinical workflows, and become the organizing principle of care delivery (Aspen 2013). Feedback loops, an essential component, compare provider performance and patient health outcomes to individual, regional and national benchmarks.

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    There is also consensus that AUC programs built on evidence-based medicine and applied in a QI context are the best method to identify appropriate care and eliminate inappropriate care, and are preferable to across-the-board payment reductions that do not differentiate interventions that add value from those that cause harm or add no value.

    2. Previous AUC Experience

    The first CMS experience with AUC, the Medicare Imaging Demonstration (MID), was required by section 135(b) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). Designed as an alternative to prior authorization, the MID's purpose was to examine whether provider exposure to appropriateness guidelines would reduce inappropriate utilization of advanced imaging services. In the 2-year demonstration which began in October 2011, nearly 4,000 physicians, grouped into one of five conveners across geographically and organizationally diverse practice settings, ordered a total of nearly 50,000 imaging studies.\1\

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    \1\ Timbie J, Hussey P, Burgette L, et al. Medicare Imaging Demonstration Final Evaluation: Report to Congress. 2014 The Rand Corporation

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    In addition to the outcomes of the MID (http://www.rand.org/content/dam/rand/pubs/research_reports/RR700/RR706/RAND_RR706.pdf), we considered others' experiences and results from implementation of imaging AUC and other evidence-based clinical guidelines at healthcare organizations such as Brigham & Women's, Intermountain Healthcare, Kaiser, Massachusetts General Hospital, and Mayo, and in states such as Minnesota. From these experiences, and analyses of them by medical societies and others, general agreement on at least two key points has emerged. First, AUC, and the clinical decision support (CDS) mechanisms through which providers access AUC, must be integrated into the clinical workflow and facilitate, not obstruct, evidence-based care delivery. Second, the ideal AUC is an evidence-based guide that starts with a patient's specific clinical condition or presentation (symptoms) and assists the provider in the overall patient workup, treatment and follow-up. Imaging would appear as key nodes within the clinical management decision tree. The end goal of using AUC is to improve patient health outcomes. In reality, however, many providers may encounter AUC through a CDS mechanism for the first time at the point of image ordering. The CDS would ideally bring the provider back to that specific clinical condition and work-up scenario to ensure and simultaneously document the appropriateness of the imaging test.

    However, there are different views about how best to roll out AUC into clinical practice. One opinion is that it is best to start with as comprehensive a library of individual AUC as possible to avoid the frustration, experienced and voiced by many practitioners participating in the MID, of spending time navigating the CDS tool only to find that, about 40 percent of the time, no AUC for their patient's specific clinical condition existed. The other opinion is that, based on decades of experience rolling out AUC in the context of robust QI programs, it is best to focus on a few priority clinical areas (for example, low back pain) at a time, to ensure that providers fully understand the AUC they are using, including when they do not apply to a particular patient. This same group also believes, based on experience with the MID, that too many low-evidence alerts or rules simply create ``alert fatigue.'' They envision that, rather than navigating through a CDS to find relevant AUC, providers would simply enter the patient's condition and a message would pop up stating whether AUC existed for that condition.

    We believe there is merit to both approaches, and it has been suggested to us that the best approach may depend on the particular care setting. The second, ``focused'' approach may work better for a large health system that produces and uses its own AUC. The first, ``comprehensive'' approach may in turn work better for a smaller practice with broad image ordering patterns and fewer resources that wants to simply adopt and start using from day one a complete AUC system developed elsewhere. We believe a successful program would allow flexibility, and under section 1834(q) of the Act, we foresee competing sets of AUC developed by different provider-led entities, and competing CDS mechanisms, from which providers may choose.

    3. Statutory Authority

    Section 218(b) of the PAMA amended the Medicare Part B statute by adding a new section 1834(q) of the Act entitled, ``Recognizing Appropriate Use Criteria for Certain Imaging Services,'' which directs us to establish a new program to promote the use of AUC. In section 1834(q)(1)(B) of the Act, AUC are defined as criteria that are evidence-based (to the extent feasible) and assist professionals who order and furnish applicable imaging services to make the most appropriate treatment decision for a specific clinical condition for an individual.

    4. Discussion of Statutory Requirements

    There are four major components of the AUC program under section 1834(q) of the Act, each with its own implementation date: (1) Establishment of AUC by November 15, 2015 (section 1834(q)(2)); (2) mechanisms for consultation with AUC by April 1, 2016 (section 1834(q)(3)); (3) AUC consultation by ordering professionals and reporting on AUC consultation by furnishing professionals by January 1, 2017 (section 1834(q)(4)); and (4) annual identification of outlier ordering professionals for services furnished after January 1, 2017 (section 1834(q)(5)). In this proposed rule, we primarily address the first component under section 1834(q)(2)--the process for establishment of AUC, along with relevant aspects of the definitions under section 1834(q)(1).

    Section 1834(q)(1) of the Act describes the program and provides definitions of terms. The program is required to promote the use of AUC for applicable imaging services furnished in an applicable setting by ordering professionals and furnishing professionals. Section 1834(q)(1) of the Act provides definitions for AUC, applicable imaging service, applicable setting, ordering professional, and furnishing professional. An ``applicable imaging service'' under section 1834(q)(1)(C) of the Act must be an advanced imaging service as defined in section 1834(e)(1)(B) of the Act, which defines ``advanced diagnostic imaging services'' to include diagnostic magnetic resonance imaging, computed tomography, and nuclear medicine (including positron emission tomography); and other diagnostic imaging services we may specify in consultation with physician specialty organizations and other stakeholders, but excluding x-ray, ultrasound and fluoroscopy services.

    Section 1834(q)(2)(A) of the Act requires the Secretary to specify applicable AUC for applicable imaging services, through rulemaking and in consultation with physicians, practitioners and other stakeholders, by November 15, 2015. Applicable AUC may be specified only from among AUC developed or endorsed by national professional medical specialty societies or other provider-led entities. Section 1834(q)(2)(B) of the Act identifies certain considerations the Secretary must take into account when specifying applicable AUC including whether the AUC have stakeholder consensus, are scientifically valid and evidence-based,

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    and are based on studies that are published and reviewable by stakeholders. Section 1834(q)(2)(C) of the Act requires the Secretary to review the specified applicable AUC each year to determine whether there is a need to update or revise them, and to make any needed updates or revisions through rulemaking. Section 1834(q)(2)(D) of the Act specifies that, if the Secretary determines that more than one AUC applies for an applicable imaging service, the Secretary shall apply one or more AUC for the service.

    The PAMA was enacted into law on April 1, 2014. Implementation of many aspects of the amendments made by section 218(b) requires consultation with physicians, practitioners, and other stakeholders, and notice and comment rulemaking. We believe the PFS rulemaking process is the most appropriate and administratively feasible implementation vehicle. Given the timing, we were not able to include proposals in the PFS proposed rule to begin implementation in the same year the PAMA was enacted. The PFS proposed rule is published in late June or early July each year. For the new Medicare AUC program to have been a part of last year's proposed rule (CY 2015), we would have had to interpret and analyze the new statutory language, and develop proposed plans for implementation in under one month. Additionally, given the complexity of the program to promote the use of AUC for advanced imaging services established under section 1834(q) of the Act, we believed it was imperative to consult with physicians, practitioners and other stakeholders in advance of developing proposals to implement the program. In the time since the legislation was enacted, we have met extensively with stakeholders to gain insight and hear their comments and concerns about the AUC program. Having this open door with stakeholders has greatly informed our proposed policy. In addition, before AUC can be specified as directed by section 1834(q)(2)(A) of the Act, there is first the need to define what AUC are and to specify the process for developing them. To ensure transparency and meet the requirements of the statute, we are proposing to implement section 1834(q)(2) of the Act by first establishing through rulemaking a process for specifying applicable AUC and proposing the requirements for AUC development. Under our proposal, the specification of AUC under section 1834(q)(2)(A) of the Act will flow from this process.

    We are also proposing to define the term, ``provider-led entity,'' which is included in section 1834(q)(1)(B) of the Act so that the public has an opportunity to comment, and entities meeting the definition are aware of the process by which they may become qualified under Medicare to develop or endorse AUC. Under our proposed process, once a provider-led entity is qualified (which includes rigorous AUC development requirements involving evidence evaluation, as provided in section 1834(q)(2)(B) of the Act and proposed in this proposed rule) the AUC that are developed or endorsed by the entity would be considered to be specified applicable AUC under section 1834(q)(2)(A) of the Act.

    The second major component of the Medicare AUC program is the identification of qualified CDS mechanisms that could be used by ordering professionals for consultation with applicable AUC under section 1834(q)(3) of the Act. We envision a CDS mechanism for consultation with AUC as an interactive tool that communicates AUC information to the user. The ordering professional would input information regarding the clinical presentation of the patient into the CDS tool, which may be a feature of or accessible through an existing system, and the tool would provide immediate feedback to the ordering professional on the appropriateness of one or more imaging services. Ideally, multiple CDS mechanisms would be available that could integrate directly into, or be seamlessly interoperable with, existing health information technology (IT) systems. This would minimize burden on provider teams and avoid duplicate documentation.

    Section 1834(q)(3)(A) of the Act states that the Secretary must specify qualified CDS mechanisms in consultation with physicians, practitioners, health care technology experts, and other stakeholders. This paragraph authorizes the Secretary to specify mechanisms that could include: CDS modules within certified EHR technology; private sector CDS mechanisms that are independent of certified EHR technology; and a CDS mechanism established by the Secretary.

    However, all CDS mechanisms must meet the requirements under section 1834(q)(3)(B) of the Act which specifies that a mechanism must: Make available to the ordering professional applicable AUC and the supporting documentation for the applicable imaging service that is ordered; where there is more than one applicable AUC specified for an applicable imaging service, indicate the criteria it uses for the service; determine the extent to which an applicable imaging service that is ordered is consistent with the applicable AUC; generate and provide to the ordering professional documentation to demonstrate that the qualified CDS was consulted by the ordering professional; be updated on a timely basis to reflect revisions to the specification of applicable AUC; meet applicable privacy and security standards; and perform such other functions as specified by the Secretary (which may include a requirement to provide aggregate feedback to the ordering professional). Section 1834(q)(3)(C) of the Act specifies that the Secretary must publish an initial list of specified mechanisms no later than April 1, 2016, and that the Secretary must identify on an annual basis the list of specified qualified CDS mechanisms.

    We are not including proposals to implement section 1834(q)(3) of the Act in this proposed rule. We need to first establish, through notice and comment rulemaking, the process for specifying applicable AUC. Specified applicable AUC would serve as the inputs to any qualified CDS mechanism, therefore, these must first be identified so that prospective tool developers are able to establish relationships with AUC developers. In addition, we anticipate that in PFS rulemaking for CY 2017, we will provide clarifications, develop definitions and establish the process by which we will specify qualified CDS mechanisms. The requirements for qualified CDS mechanisms set forth in section 1834(q)(3)(B) of the Act will also be vetted through PFS rulemaking for CY 2017 so that mechanism developers have a clear understanding and notice regarding the requirements for their tools. The CY 2017 proposed rule would be published at the end of June or in early July of 2016, be open for a period of public comment, and then the final rule would be published by November 1, 2016. We anticipate that the initial list of specified applicable CDS mechanisms will be published sometime after the CY 2017 PFS final rule. In advance of these actions, we will continue to work with stakeholders to understand how to ensure that appropriate mechanisms are available, particularly with respect to standards for certified health IT, including EHRs, that can enable interoperability of AUC across systems.

    The third major component of the AUC program is in section 1834(q)(4) of the Act, Consultation with Applicable Appropriate Use Criteria. This section establishes, beginning January 1, 2017, the requirement for an ordering professional to consult with a listed qualified CDS mechanism when ordering an applicable imaging service that would be furnished in an

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    applicable setting and paid for under an applicable payment system; and for the furnishing professional to include on the Medicare claim information about the ordering professional's consultation with a qualified CDS mechanism. The statute distinguishes between the ordering and furnishing professional, recognizing that the professional who orders the imaging service is usually not the same professional who bills Medicare for the test when furnished. Section 1834(q)(4)(C) of the Act provides for certain exceptions to the AUC consultation and reporting requirements including in the case of certain emergency services, inpatient services paid under Medicare Part A, and ordering professionals who obtain a hardship exemption. Section 1834(q)(4)(D) of the Act specifies that the applicable payment systems for the AUC consultation and reporting requirements are the physician fee schedule, hospital outpatient prospective payment system, and the ambulatory surgical center payment system.

    We are not including proposals to implement section 1834(q)(4) of the Act in this proposed rule. Again, it is important that we first establish through notice and comment rulemaking the process by which applicable AUC will be specified as well as the CDS mechanisms through which ordering providers would access them. We anticipate including further discussion and adopting policies regarding claims-based reporting requirements in the CY 2017 and CY 2018 rulemaking cycles.

    The fourth component of the AUC program is in section 1834(q)(5) of the Act, Identification of Outlier Ordering Professionals. The identification of outlier ordering professionals under this paragraph facilitates a prior authorization requirement for outlier professionals beginning January 1, 2020, as specified under section 1834(q)(6) of the Act. Although, we are not including proposals to implement these sections in this proposed rule, we are proposing to identify outlier ordering professionals from within priority clinical areas that would be established through subsequent rulemaking. In this rule, we propose a process to provide clarity around priority clinical areas.

    The concept of priority clinical areas allows CMS to implement an AUC program that combines two approaches to implementation. Under our proposed policy, while potentially large volumes of AUC would become specified across clinical conditions and advanced imaging technologies, we believe this rapid roll out of specified AUC should be balanced with a more focused approach to identifying outlier ordering professionals. We believe this will provide an opportunity for physicians and practitioners to become familiar with AUC in identified priority clinical areas prior to Medicare claims for those services being part of the input for calculating outlier ordering professionals.

    In future rulemaking, with the benefit of public comments, we will establish priority clinical areas and expand them over time. Also in future rulemaking, we will develop and clarify our policy to identify outlier ordering professionals.

    5. Proposals for Implementation

    We are proposing to amend our regulations to add a new Sec. 414.94, ``Appropriate Use Criteria for Certain Imaging Services.''

    a. Definitions

    In Sec. 414.94 (b), we are proposing to codify and add language to clarify some of the definitions provided in section 1834(q)(1) of the Act as well as define terms that were not defined in statute but for which a definition would be helpful for program implementation. In this section of the proposed rule, we provide a description of the terms we are proposing to codify to facilitate understanding and encourage public comment on the proposed AUC program.

    Due to circumstances unique to imaging, it is important to note that there is an ordering professional (the physician or practitioner that orders that the imaging service be performed) and a furnishing professional (the physician or practitioner that actually performs the imaging service and provides the radiologic interpretation of the image) involved in imaging services. In some cases the ordering professional and the furnishing professional are the same.

    This proposed AUC program only applies in applicable settings. An applicable setting would include a physician's office, a hospital outpatient department (including an emergency department) and an ambulatory surgical center. The inpatient hospital setting, for example, is not an applicable setting. Further, the proposed program only applies to applicable imaging services. These are advanced diagnostic imaging services for which one or more applicable AUC apply, one or more qualified CDS mechanisms is available, and one of those mechanisms is available free of charge.

    We are proposing to clarify the definition for appropriate use criteria, which is defined in statute to include only criteria developed or endorsed by national professional medical specialty societies or other provider-led entities, to assist ordering professionals and furnishing professionals in making the most appropriate treatment decision for a specific clinical condition for an individual. To the extent feasible, such criteria shall be evidence-

    based. To further describe AUC, we are proposing to add the following language to this definition: AUC are a collection of individual appropriate use criteria. Individual criteria are information presented in a manner that links: A specific clinical condition or presentation; one or more services; and, an assessment of the appropriateness of the service(s).

    For the purposes of implementing this program, we are proposing to define new terms in Sec. 414.94(b). A provider-led entity would include national professional medical specialty societies (for example the American College of Radiology and the American Academy of Family Physicians) or an organization that is comprised primarily of providers and is actively engaged in the practice and delivery of healthcare (for example hospitals and health systems). Applicable AUC become specified when they are developed, modified or endorsed by a qualified provider-

    led entity. A provider-led entity is not considered qualified until CMS makes a determination via the qualification process discussed in this proposal. We are introducing priority clinical areas to inform ordering professionals and furnishing professionals of the clinical topics, clinical topics and imaging modalities or imaging modalities that may be identified by the agency through annual rulemaking and in consultation with stakeholders which may be used in the identification of outlier ordering professionals.

    The proposed definitions in Sec. 414.94 are important in understanding our proposals for implementation. Only AUC developed, modified or endorsed by organizations meeting the definition of provider-led entity would be considered specified applicable AUC. As required by the statute, specified applicable AUC, which encompass all AUC developed, modified or endorsed by qualified provider-led entities, must be consulted and such consultation must be reported on the claim for applicable imaging services. To assist in identification of outlier ordering professionals, we propose to focus on priority clinical areas. Priority clinical areas would be associated with a subset of specified AUC.

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    b. AUC Development by Provider-Led Entities

    In Sec. 414.94, we are proposing to include regulations to implement the first component of the Medicare AUC program--

    specification of applicable AUC. We are first proposing a process by which provider-led entities (including national professional medical specialty societies) become qualified by Medicare to develop or endorse AUC. The cornerstone of this process is for provider-led entities to demonstrate that they engage in a rigorous evidence-based process for developing, modifying, or endorsing AUC. It is through this demonstration that we propose to meet the requirements of section 1834(q)(2)(B) of the Act to take into account certain considerations for the AUC. Section 1834(q)(2)(B) specifies that the Secretary must consider whether AUC have stakeholder consensus, are scientifically valid and evidence-based, and are based on studies that are published and reviewable by stakeholders. It is not feasible for us to review every individual criterion. Rather, we propose to establish a qualification process and requirements for qualified provider-led entities in order to ensure that the AUC development or endorsement processes used by a provider-led entity result in high quality, evidence-based AUC in accordance with section 1834(q)(2)(B). Therefore, we propose that AUC developed, modified, or endorsed by qualified provider-led entities will constitute the specified applicable AUC that ordering professionals would be required to consult when ordering applicable imaging services.

    In order to become and remain a qualified provider-led entity, we propose to require a provider-led entity to demonstrate adherence to specific requirements when developing, modifying or endorsing AUC. The first proposed requirement is related to the evidentiary review process for individual criteria. Entities must engage in a systematic literature review of the clinical topic and relevant imaging studies. We would expect the literature review to include evidence on analytical validity, clinical validity, and clinical utility of the specific imaging study. In addition, the provider-led entity must assess the evidence using a formal, published, and widely recognized methodology for grading evidence. Consideration of relevant published evidence-

    based guidelines and consensus statements by professional medical specialty societies must be part of the evidence assessment. Published consensus statements may form part of the evidence base of AUC and would be subject to the evidentiary grading methodology as any other evidence identified as part of a systematic review.

    In addition, we propose that the provider-led entity's AUC development process must be led by at least one multidisciplinary team with autonomous governance that is accountable for developing, modifying, or endorsing AUC. At a minimum, the team must be composed of three members including one with expertise in the clinical topic related to the criterion and one with expertise in imaging studies related to the criterion. We encourage such teams to be larger, and include experts in each of the following domains: Statistical analysis (such as biostatics, epidemiology, and applied mathematics); clinical trial design; medical informatics; and quality improvement. A given team member may be the team's expert in more than one domain. These experts should contribute substantial work to the development of the criterion, not simply review the team's work.

    Another important area to address that provides additional assurance regarding quality and evidence-based AUC development is the disclosure of conflicts of interest. We believe it is appropriate to impose relatively stringent requirements for public transparency and disclosure of potential conflicts of interest for anyone participating with a provider-led entity in the development of AUC. We propose that the provider-led entity must have a publicly transparent process for identifying and disclosing potential conflicts of interest of members on the multidisciplinary AUC development team. The provider-led entity must disclose any direct or indirect relationships, as well as ownership or investment interests, among the multidisciplinary team members or immediate family members and organizations that may financially benefit from the AUC that are being considered for development, modification or endorsement.

    For individual criteria to be available for practitioners to review prior to incorporation into a CDS mechanism, we propose that the provider-led entity must maintain on its Web site each criterion that is part of the AUC that the entity has considered or is considering for development, modification, or endorsement. This public transparency of individual criteria is critical not only to ordering and furnishing professionals, but also to patients and other health care providers who may wish to view all available AUC.

    Although evidence should be the foundation for the development, modification and endorsement of AUC, we recognize that not all aspects of a criterion will be evidence-based, and that a criterion does not exist for every clinical scenario. We believe it is important for AUC users to understand which aspects of a criterion are evidence-based and which are consensus-based. Therefore, we propose that key decision points in individual criteria be graded in terms of strength of evidence using a formal, published, and widely recognized methodology. This level of detail must be part of each AUC posted to the entity's Web site.

    It is critical that as provider-led entities develop large collections of AUC, they have a transparent process for the timely and continual review of each criterion, as there are sometimes rapid changes in the evidence base for certain clinical conditions and imaging studies.

    Finally, we propose that a provider-led entity's process for developing, modifying, or endorsing AUC (which would be inclusive of the requirements being proposed in this rule) must be publicly posted on the entity's Web site.

    We believe it is important to fit AUC to local circumstances and populations, while also ensuring a rigorous due process for doing so. Under our proposed AUC program, local adaptation of AUC might happen in three ways. First, compatibility with local practice is something that ordering professionals can assess when selecting AUC for consultation. Second, professional medical societies (many of which have state chapters) and large health systems (which incorporate diverse practice settings, both urban and rural) that become qualified provider-led entities can get local feedback at the outset and build alternative options into the design of their AUC. Third, local provider-led entities can themselves become qualified to develop, modify, or endorse AUC.

    c. Process for Provider-Led Entities To Become Qualified To Develop, Endorse or Modify AUC

    We are proposing that provider-led entities must apply to CMS to become qualified. We are proposing that entities that believe they meet the definition of provider-led submit applications to us that document adherence to each of the qualification requirements. The application must include a statement as to how the entity meets the definition of a provider-led entity. Applications will be accepted each year but must be received by January 1. A list of all applicants that we determine to be

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    qualified provider-led entities will be posted to our Web site by the following June 30 at which time all AUC developed or endorsed by that provider-led entity will be considered to be specified AUC. All qualified provider-led entities must re-apply every 6 years and their applications must be received by January 1 during the 5th year of their approval. Note that the application is not a CMS form; rather it is created by the applicant entity.

    d. Identifying Priority Clinical Areas

    Section 1834(q)(4) of the Act requires that, beginning January 1, 2017, ordering professionals must consult applicable AUC using a qualified CDS mechanism when ordering applicable imaging services for which payment is made under applicable payment systems, and that furnishing professionals must report the results of this consultation on Medicare claims. Section 1834(q)(5) of the Act further provides for the identification of outlier ordering professionals based on a low adherence to applicable AUC. We are proposing to identify priority clinical areas of AUC that we will use in identifying outlier ordering professionals. Although there is no consequence to being identified as an outlier ordering professional until January 2020, it is important to allow ordering and furnishing professionals as much time as possible to use and familiarize themselves with the specified applicable AUC that will eventually become the basis for identifying outlier ordering professionals.

    To identify these priority clinical areas, we may consider incidence and prevalence of diseases, as well as the volume, variability of utilization, and strength of evidence for imaging services. We may also consider applicability of the clinical area to a variety of care settings, and to the Medicare population. We are proposing to annually solicit public comment and finalize clinical priority areas through the PFS rulemaking process beginning in CY 2017. To further assist us in developing the list of proposed priority clinical areas, we are proposing to convene the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC), a CMS FACA compliant committee, as needed to examine the evidence surrounding certain clinical areas.

    Specified applicable AUC falling within priority clinical areas may factor into the low-adherence calculation when identifying outlier ordering professionals for the prior authorization component of this statute, which is slated to begin in 2020. Future rulemaking will address further details.

    e. Identification of Non-Evidence Based AUC

    Despite our proposed provider-led entity qualification process that should ensure evidence-based AUC development, we remain concerned that non-evidence based criteria may be developed or endorsed by qualified provider-led entities. Therefore, we are proposing a process by which we would identify and review potentially non-evidence-based criteria that fall within one of our identified priority clinical areas. We are proposing to accept public comment through annual PFS rulemaking so that the public can assist in identifying AUC that potentially are not evidence-based. We foresee this being a standing request for comments in all future rules regarding AUC. We are proposing to use the MEDCAC to further review the evidentiary basis of these identified AUC, as needed. The MEDCAC has extensive experience in reviewing, interpreting, and translating evidence. If through this process, a number of criteria from an AUC library are identified as being insufficiently evidence-

    based, and the provider-led entity that produced the library does not make a good faith attempt to correct these in a timely fashion, this information could be considered when the provider-led entity applies for re-qualification.

    6. Summary

    Section 1834(q) of the Act includes rapid timelines for establishing a new Medicare AUC program for advanced imaging services. The number of clinicians impacted by the scope of this program is massive as it will apply to every physician and practitioner who orders applicable diagnostic imaging services. This crosses almost every medical specialty and could have a particular impact on primary care physicians since their scope of practice can be quite vast.

    We believe the best implementation approach is one that is diligent, maximizes the opportunity for public comment and stakeholder engagement, and allows for adequate advance notice to physicians and practitioners, beneficiaries, AUC developers, and CDS mechanism developers. It is for these reasons we are proposing a stepwise approach, adopted through rulemaking, to first define and lay out the process for the Medicare AUC program. However, we also recognize the importance of moving expeditiously to accomplish a fully implemented program.

    In summary, we are proposing definitions of terms necessary to implement the AUC program. We are particularly seeking comment on the proposed definition of provider-led entity as these are the organizations that have the opportunity to become qualified to develop, modify or endorse specified AUC. We are also proposing an AUC development process which allows some flexibility for provider-led entities but sets standards including an evidence-based development process and transparency. In addition, we are proposing the concept and definition of priority clinical areas and how they may contribute to the identification of outlier ordering professionals. Lastly, we are proposing to develop a process by which non-evidence-based AUC will be identified and discussed in the public domain. We invite the public to submit comments on these proposals.

  47. Physician Compare Web Site

    1. Background and Statutory Authority

    As required by section 10331(a)(1) of the Affordable Care Act, by January 1, 2011, we developed a Physician Compare Internet Web site with information on physicians enrolled in the Medicare program under section 1866(j) of the Act, as well as information on other eligible professionals (EPs) who participate in the Physician Quality Reporting System (PQRS) under section 1848 of the Act. We launched the first phase of Physician Compare on December 30, 2010 (http://www.medicare.gov/physiciancompare). In the initial phase, we posted the names of EPs that satisfactorily submitted quality data for the 2009 PQRS, as required by section 1848(m)(5)(G) of the Act.

    We also implemented, consistent with section 10331(a)(2) of the Affordable Care Act, a plan for making publicly available through Physician Compare information on physician performance that provides comparable information on quality and patient experience measures for reporting periods beginning no earlier than January 1, 2012. We met this requirement in advance of the statutory deadline of January 1, 2013, as outlined below, and plan to continue addressing elements of the plan through rulemaking.

    To the extent that scientifically sound measures are developed and are available, we are required to include, to the extent practicable, the following types of measures for public reporting:

    Measures collected under the Physician Quality Reporting System (PQRS).

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    An assessment of patient health outcomes and functional status of patients.

    An assessment of the continuity and coordination of care and care transitions, including episodes of care and risk-adjusted resource use.

    An assessment of efficiency.

    An assessment of patient experience and patient, caregiver, and family engagement.

    An assessment of the safety, effectiveness, and timeliness of care.

    Other information as determined appropriate by the Secretary.

    In developing and implementing the plan, section 10331(b) requires that we include, to the extent practicable, the following:

    Processes to ensure that data made public are statistically valid, reliable, and accurate, including risk adjustment mechanisms used by the Secretary.

    Processes for physicians and EPs whose information is being publicly reported to have a reasonable opportunity, as determined by the Secretary, to review their results before posting to Physician Compare. We have established a 30-day preview period for all measurement performance data that will allow physicians and other EPs to view their data as it will appear on the Web site in advance of publication on Physician Compare (77 FR 69166, 78 FR 74450, and 79 FR 67770). Details of the preview process will be communicated directly to those with measures to preview and will also be published on the Physician Compare Initiative page (http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/physician-compare-initiative/) in advance of the preview period.

    Processes to ensure the data published on Physician Compare provides a robust and accurate portrayal of a physician's performance.

    Data that reflects the care provided to all patients seen by physicians, under both the Medicare program and, to the extent applicable, other payers, to the extent such information would provide a more accurate portrayal of physician performance.

    Processes to ensure appropriate attribution of care when multiple physicians and other providers are involved in the care of the patient.

    Processes to ensure timely statistical performance feedback is provided to physicians concerning the data published on Physician Compare.

    Implementation of computer and data infrastructure and systems used to support valid, reliable and accurate reporting activities.

    Section 10331(d) of the Affordable Care Act requires us to consider input from multi-stakeholder groups, consistent with sections 1890(b)(7) and 1890A of the Act, when selecting quality measures for Physician Compare. We also continue to get general input from stakeholders on Physician Compare through a variety of means, including rulemaking and different forms of stakeholder outreach (for example, Town Hall meetings, Open Door Forums, webinars, education and outreach, Technical Expert Panels, etc.).

    We submitted a report to the Congress in advance of the January 1, 2015 deadline, as required by section 10331(f) of the Affordable Care Act, on Physician Compare development, including information on the efforts and plans to collect and publish data on physician quality and efficiency and on patient experience of care in support of value-based purchasing and consumer choice.

    We believe section 10331 of the Affordable Care Act supports our overarching goals of providing consumers with quality of care information that will help them make informed decisions about their health care, while encouraging clinicians to improve the quality of care they provide to their patients. In accordance with section 10331 of the Affordable Care Act, we plan to continue to publicly report physician performance information on Physician Compare.

    2. Public Reporting of Performance and Other Data

    Since the initial launch of the Web site, we have continued to build on and improve Physician Compare, including a full redesign in 2013. Currently, Web site users can view information about approved Medicare professionals such as name, primary and secondary specialties, practice locations, group affiliations, hospital affiliations that link to the hospital's profile on Hospital Compare as available, Medicare Assignment status, education, residency, and American Board of Medical Specialties (ABMS) board certification information. In addition, for group practices, users can view group practice names, specialties, practice locations, Medicare assignment status, and affiliated professionals.

    In addition, there is a section on each Medicare professional's profile page indicating with a green check mark the quality programs under which the EP satisfactorily or successfully reported. The Web site will continue to post annually the names of individual EPs who satisfactorily report under PQRS, EPs who successfully participate in the Medicare Electronic Health Record (EHR) Incentive Program as authorized by section 1848(o)(3)(D) of the Act, and EPs who report PQRS measures in support of Million Hearts (79 FR 67763). A proposed change to the Million Hearts indicator for 2016 data is discussed below.

    With the 2013 redesign of the Physician Compare Web site, we added a quality programs section to each group practice profile page, as well. We will continue to indicate which group practices are satisfactorily reporting in the Group Practice Reporting Option (GPRO) under PQRS (79 FR 67763). The Physician Compare Web site also contains a link to the Physician Compare downloadable database (https://data.medicare.gov/data/physician-compare), including information on this quality program participation.

    We continue to implement our plan for a phased approach to public reporting performance information on the Physician Compare Web site. Under the first phase of this plan, we established that GPRO measures collected under PQRS through the Web Interface for 2012 would be publicly reported on Physician Compare (76 FR 73419 through 73420). We further expanded the plan by including on the Physician Compare Web site the 2013 group practice-level PQRS measures for Diabetes Mellitus (DM) and Coronary Artery Disease (CAD) reported via the Web Interface, and planned to report composite measures for DM and CAD in 2014, as well (77 FR 69166).

    The 2012 GPRO measures were publicly reported on Physician Compare in February 2014. The 2013 PQRS GPRO DM and GPRO CAD measures collected via the Web Interface that met the minimum sample size of 20 patients and proved to be statistically valid and reliable were publicly reported on Physician Compare in December 2014. The composite measures were not reported, however, as some items included in the composites were no longer clinically relevant. If the minimum threshold is not met for a particular measure, or the measure is otherwise deemed not to be suitable for public reporting, the performance rate on that measure is not publicly reported. On the Physician Compare Web site, we only publish those measures that are statistically valid and reliable, and therefore, most likely to help consumers make informed decisions about the Medicare professionals they choose to meet their health care needs. In addition, we do not publicly report first year measures, meaning new PQRS and non-PQRS measures that have been available for

    Page 41809

    reporting for less than one year, regardless of reporting mechanism. After a measure's first year in use, we will evaluate the measure to see if and when the measure is suitable for public reporting.

    Measures must be based on reliable and valid data elements to be useful to consumers. Therefore, for all proposed measures available for public reporting, including both group and individual EP level measures--regardless of reporting mechanism, only those proposed measures that prove to be valid, reliable, and accurate upon analysis and review at the conclusion of data collection and that meet the established public reporting criteria of a minimum sample size of 20 patients will be included on Physician Compare. For information on how we determine the validity and reliability of data and other statistical analyses we perform, refer to the CY 2015 PFS final rule with comment period (79 FR 67764 through 79 FR 67765).

    We will also continue to include an indicator of which reporting mechanism was used and to only include on the site measures deemed statistically comparable.\2\ We will continue to publicly report all measures submitted and reviewed and found to be statistically valid and reliable in the Physician Compare downloadable file. However, not all of these measures would necessarily be included on the Physician Compare profile pages. Consumer testing has shown profile pages with too much information and measures that are not well understood by consumers can negatively impact a consumer's ability to make informed decisions. Our analysis of the collected measure data, along with consumer testing and stakeholder feedback, will determine specifically which measures are published on Web site profile pages. Statistical analyses, like those specified above, will ensure the measures included are statistically valid and reliable and comparable across data collection mechanisms. Stakeholder feedback will help us to ensure that all publicly reported measures meet current clinical standards. When measures are finalized in advance of the time period in which they are collected, it is possible that clinical guidelines can change rendering a measure no longer relevant. Publishing that measure can lead to consumer confusion regarding what best practices their health care professional should be subscribing to. We will continue to reach out to stakeholders in the professional community, such as specialty societies, to ensure that the measures under consideration for public reporting remain clinically relevant and accurate.

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    \2\ By statistically comparable, CMS means that the quality measures are analyzed and proven to measure the same phenomena in the same way regardless of the mechanism through which they were collected.

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    The primary goal of Physician Compare is to help consumers make informed health care decisions. If a consumer does not properly interpret a quality measure and thus misunderstands what the quality score represents, the consumer cannot use this information to make an informed decision. Through concept testing, we will test with consumers how well they understand measures presented using plain language. Such consumer testing will help us gauge how measures are understood and the kinds of measures that are most relevant to consumers. This will be done to help ensure that the information included on Physician Compare is as consumer friendly and consumer focused as possible.

    As is the case for all measures published on Physician Compare, individual EPs and group practices will be given a 30-day preview period to view their measures as they will appear on Physician Compare prior to the measures being published. As in previous years, we will fully explain the process for the 30-day preview and provide a detailed timeline and instructions for preview in advance of the start of the preview period.

    We also report certain Accountable Care Organization (ACO) quality measures on Physician Compare (76 FR 67802, 67948). Because EPs that bill under the TIN of an ACO participant are considered to be a group practice for purposes of qualifying for a PQRS incentive under the Medicare Shared Savings Program (Shared Savings Program), we publicly report ACO performance on quality measures on the Physician Compare Web site in the same way as we report performance on quality measures for group practices participating under PQRS. Public reporting of performance on these measures is presented at the ACO level only. The first subset of ACO measures was also published on the Web site in February 2014. ACO measures can be viewed by following the ``Accountable Care Organization (ACO) Quality Data'' link on the homepage of the Physician Compare Web site (http://medicare.gov/physiciancompare/aco/search.html ).

    ACOs will be able to preview their quality data that will be publicly reported on Physician Compare through the ACO Quality Reports, which will be made available to ACOs for review at least 30 days prior to the start of public reporting on Physician Compare. The quality reports will indicate the measures that are available for public reporting. ACO measures will be publicly reported in plain language, so a crosswalk linking the technical language included in the Quality Report and the plain language that will be publicly reported will be provided to ACOs at least 30 days prior to the start of public reporting.

    As part of our public reporting plan for Physician Compare, we also have available for public reporting patient experience measures, specifically reporting the CAHPS for PQRS measures, which relate to the Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) data, for group practices of 100 or more EPs reporting data in 2013 under PQRS and for ACOs participating in the Shared Savings Program (77 FR 69166 and 69167). The 2013 CAHPS data for ACOs were publicly reported on Physician Compare in December 2014.

    We continued to expand our plan for publicly reporting data on Physician Compare in 2015. We plan to make all group practice-level measures collected through the Web Interface for groups of 25 or more EPs participating in 2014 under the PQRS and for ACOs participating in the Shared Savings Program available for public reporting in CY 2015 (78 FR 74449). We also plan to publicly report performance on certain measures that group practices report via registries and EHRs for the 2014 PQRS GPRO (78 FR 74451). Specifically, we finalized a decision to make available for public reporting on Physician Compare performance on 16 registry measures and 13 EHR measures in CY 2015 (78 FR 74451). These measures are consistent with the measures available for public reporting via the Web Interface.

    In CY 2015, CAHPS measures for group practices of 100 or more EPs who participate in PQRS, regardless of data submission method, and for Shared Savings Program ACOs reporting through the Web Interface or other CMS-approved tool or interface are available for public reporting (78 FR 74452). In addition, twelve 2014 summary survey measures for groups of 25 to 99 EPs collected via any certified CAHPS vendor regardless of PQRS participation are available for public reporting (78 FR 74452). For ACOs participating in the Shared Savings Program, the patient experience measures that are included in the Patient/Caregiver Experience domain of the Quality Performance Standard under the Shared Savings Program will be available for public reporting in CY 2015 (78 FR 74452).

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    In late CY 2015, certain 2014 individual PQRS measure data reported by individual EPs are also available for public reporting. Specifically, we will make available for public reporting 20 individual measures collected through a registry, EHR, or claims (78 FR 74453 through 74454). These are measures that are in line with those measures reported by groups via the Web Interface.

    Finally, in support of the HHS-wide Million Hearts initiative, performance rates on measures in the PQRS Cardiovascular Prevention measures group at the individual EP level for data collected in 2014 for the PQRS are available for public reporting in CY 2015 (78 FR 74454).

    We continue to expand public reporting on Physician Compare by making an even broader set of quality measures available for publication on the Web site in CY 2016. All 2015 group-level PQRS measures across all group reporting mechanisms--Web Interface, registry, and EHR--are available for public reporting on Physician Compare in CY 2016 for groups of 2 or more EPs (79 FR 67769). Similarly, we decided that all measures reported by ACOs participating in the Shared Savings Program will be available for public reporting on Physician Compare.

    Understanding the value of patient experience data for Physician Compare, CMS decided to report twelve 2015 CAHPS for PQRS summary survey measures for all group practices of two or more EPs, who meet the specified sample size requirements and collect data via a CMS-

    specified certified CAHPS vendor, are available for public reporting in CY 2016 (79 FR 67772).

    To provide the opportunity for more EPs to have measures included on Physician Compare, and to provide more information to consumers to make informed decisions about their health care, we will make available for public reporting in CY 2016 on Physician Compare all 2015 PQRS measures for individual EPs collected through a registry, EHR, or claims (79 FR 67773).

    Furthermore, in support of the HHS-wide Million Hearts initiative, we will publicly report the performance rates on the four, 2015 PQRS measures reported by individual EPs in support of Million Hearts with a minimum sample size of 20 patients.

    To further support the expansion of quality measure data available for public reporting on Physician Compare and to provide more quality data to consumers to help them make informed decisions, CMS finalized 2015 Qualified Clinical Data Registry (QCDR) PQRS and non-PQRS measure data collected at the individual EP level are available for public reporting. The QCDR is required to declare during their self-nomination if they plan to post data on their own Web site and allow Physician Compare to link to it or if they will provide data to CMS for public reporting on Physician Compare. Measures collected via QCDRs must also meet the established public reporting criteria. Both PQRS and non-PQRS measures that are in their first year of reporting by a QCDR will not be available for public reporting (79 FR 67774 through 67775).

    See Table 18 for a summary of our previously finalized policies for public reporting data on Physician Compare.

    Table 18--Summary of Previously Finalized Policies for Public Reporting on Physician Compare

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    Quality measures and data for public

    Data collection year Public reporting year Reporting mechanism(s) reporting

    ----------------------------------------------------------------------------------------------------------------

    2012.................. 2013................... Web Interface (WI), Include an indicator for satisfactory

    EHR, Registry, Claims. reporters under PQRS, successful e-

    prescribers under eRx Incentive

    Program, and participants in the EHR

    Incentive Program.

    2012.................. February 2014.......... WI..................... 5 Diabetes Mellitus (DM) and Coronary

    Artery Disease (CAD) measures

    collected via the WI for group

    practices reporting under PQRS with a

    minimum sample size of 25 patients

    and Shared Savings Program ACOs.

    2013.................. 2014................... WI, EHR, Registry, Include an indicator for satisfactory

    Claims. reporters under PQRS, successful e-

    prescribers under eRx Incentive

    Program, and participants in the EHR

    Incentive Program. Include an

    indicator for EPs who earn a PQRS

    Maintenance of Certification

    Incentive and EPs who report the PQRS

    Cardiovascular Prevention measures

    group in support of Million Hearts.

    2013.................. December 2014.......... WI..................... 3 DM and 1 CAD measures collected via

    the WI for groups of 25 or more EPs

    with a minimum sample size of 20

    patients.

    2013.................. December 2014.......... Survey Vendor.......... 6 CAHPS for ACO summary survey

    measures for Shared Savings Program

    ACOs.

    2014.................. Expected to be 2015.... WI, EHR, Registry, Include an indicator for satisfactory

    Claims. reporters under PQRS and participants

    in the EHR Incentive Program. Include

    an indicator for EPs who earn a PQRS

    Maintenance of Certification

    Incentive and EPs who report the PQRS

    Cardiovascular Prevention measures

    group in support of Million Hearts.

    2014.................. Expected to be late WI, EHR, Registry...... All measures reported via the WI, 13

    2015. EHR, and 16 registry measures for

    group practices of 2 or more EPs

    reporting under PQRS with a minimum

    sample size of 20 patients.

    Include composites for DM and CAD, if

    available.

    2014.................. Expected to be late WI, Survey Vendor All measures reported by Shared

    2015. Administrative Claims. Savings Program ACOs, including CAHPS

    for ACO and claims based measures.

    2014.................. Expected to be late WI, Certified Survey Up to 12 CAHPS for PQRS summary

    2015. Vendor. measures for groups of 100 or more

    EPs reporting via the WI and group

    practices of 25 to 99 EPs reporting

    via a CMS-approved certified survey

    vendor.

    2014.................. Expected to be late Registry, EHR, or A sub-set of 20 PQRS measures

    2015. Claims. submitted by individual EPs that

    align with those available for group

    reporting via the WI and that are

    collected through registry, EHR, or

    claims with a minimum sample size of

    20 patients.

    2014.................. Expected to be late Registry............... Measures from the Cardiovascular

    2015. Prevention measures group reported by

    individual EPs in support of Million

    Hearts with a minimum sample size of

    20 patients.

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    2015.................. Expected to be late WI, EHR, Registry, Include an indicator for satisfactory

    2016. Claims. reporters under PQRS and participants

    in the EHR Incentive Program. Include

    an indicator for EPs who report 4

    individual PQRS measures in support

    of Million Hearts.

    2015.................. Expected to be late WI, EHR, Registry...... All PQRS measures for group practices

    2016. of 2 or more EPs.

    2015.................. Expected to be late WI, Survey Vendor All measures reported by Shared

    2016. Administrative Claims. Savings Program ACOs, including CAHPS

    for ACOs and claims based measures.

    2015.................. Expected to be late Certified Survey Vendor All CAHPS for PQRS measures reported

    2016. for groups of 2 or more EPs who meet

    the specified sample size

    requirements and collect data via a

    CMS-specified certified CAHPS vendor.

    2015.................. Expected to be late Registry, EHR, or All PQRS measures for individual EPs

    2016. Claims. collected through a registry, EHR, or

    claims.

    2015.................. Expected to be late Registry, EHR, or 4 PQRS measures reported by individual

    2016. Claims. EPs in support of Million Hearts with

    a minimum sample size of 20 patients.

    2015.................. Expected to be late QCDR................... All individual EP QCDR measures,

    2016. including PQRS and non-PQRS measures.

    ----------------------------------------------------------------------------------------------------------------

    3. Proposed Policies for Public Data Disclosure on Physician Compare

    We are expanding public reporting on Physician Compare by continuing to make a broad set of quality measures available for publication on the Web site. We started the phased approach with a small number of possible PQRS GPRO Web Interface measures for 2012 and have been steadily building on this to provide Medicare consumers with more information to help them make informed health care decisions. As a result, we are now proposing to add new data elements to the individual EP and/or group practice profile pages and to continue to publicly report a broad set of quality measures on the Web site.

    a. Value Modifier

    We propose to expand the section on each individual EP and group practice profile page that indicates Medicare quality program participation with a green check mark to include the names of those individual EPs and group practices who received an upward adjustment for the Value Modifier (VM). We propose to include this on Physician Compare annually. For the 2018 VM, this information would be based on 2016 data and included on the site no earlier than late 2017. The VM upward adjustment indicates that a physician or group has achieved one of the following: higher quality care at a lower cost; higher quality care at an average cost; or average quality care at a lower cost. The first goal of the HHS Strategic Plan is to strengthen health care. One of the ways to do this is to reduce the growth of health care costs while promoting high-value, effective care (Objective D, Strategic Goal 1).\3\ This VM indicator can help consumers identify higher quality care provided at a lower cost. This means this type of quality information may be very useful to consumers as they work to choose the best possible health care available to them. Including the check mark is a way to share what can be a very complex concept in a user-friend, easy-to-understand format. We believe this is a positive first step in making this important information available to the public in a way that is most likely to be accurately interpreted and beneficial. We solicit comments on this proposal.

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    \3\ http://www.hhs.gov/strategic-plan/goal1.html.

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    b. Million Hearts

    In support of the HHS-wide Million Hearts initiative, we include an indicator for individual EPs who choose to report on specific ``ABCS'' (Appropriate Aspirin Therapy for those who need it, Blood Pressure Control, Cholesterol Management, and Smoking Cessation) measures (79 FR 67764). Based on available measures the criteria for this indicator have evolved over time. In 2015, an indicator was included if EPs satisfactorily reported four individual PQRS Cardiovascular Prevention measures. In previous years, the indicator was based on satisfactory reporting of the Cardiovascular Prevention measures group, which was not available via PQRS for 2015. To further support this initiative, we now propose to include on Physician Compare annually in the year following the year of reporting (for example, 2016 data will be included on Physician Compare in 2017) an indicator for individual EPs who satisfactorily report the new Cardiovascular Prevention measures group being proposed under PQRS, should this measures group be finalized. The Million Hearts initiative's primary goal is to improve cardiovascular heart health, and therefore, we believe it is important to continue supporting the program and acknowledging those physicians and other health care professionals working to excel in performance on the ABCS. We solicit comments on this proposal.

    c. PQRS GPRO and ACO Reporting

    Understanding the importance of including quality data on Physician Compare to support the goals of section 10331(a) of the Affordable Care Act, we finalized in the CY 2015 PFS final rule with comment period (79 FR 67547) a decision to publicly report on Physician Compare all PQRS GPRO measures collected in 2015 via the Web Interface, registry, or EHR. We propose to continue to make available for public reporting on Physician Compare on an annual basis all PQRS GPRO measures across all PQRS group practice reporting mechanisms--Web Interface, registry, and EHR- for groups of 2 or more EPs available in the year following the year the measures are reported. Similarly, all measures reported by Shared Savings Program ACOs, including CAHPS for ACO measures, would be available for public reporting on Physician Compare annually in the year following the year the measures are reported. For group practice and ACO measures, the measure performance rate will be represented on the Web site. We solicit comments on this proposal.

    d. Individual EP PQRS Reporting

    Consumer testing indicates that consumers are looking for measures regarding individual doctors and other health care professionals. As a result, we plan to make available for public reporting on Physician Compare all 2015 PQRS measures for individual EPs collected through a registry, EHR, or claims (79 FR 67773). Through

    Page 41812

    stakeholder outreach and consumer testing we have learned that these PQRS quality data provide the public with useful information to help consumers make informed decisions about their health care. As a result, we propose to continue to make all PQRS measures across all individual EP reporting mechanisms available for public reporting on Physician Compare annually in the year following the year the measures are reported (for example, 2016 data will be included on Physician Compare in 2017). For individual EP measures, the measure performance rate will be represented on the Web site. We solicit comments on this proposal.

    e. Individual EP and Group Practice QCDR Measure Reporting

    Stakeholder outreach and consumer testing have repeatedly shown that consumers find individual EP quality measures valuable and helpful when making health care decisions. Consumers want to know more about the individual EPs they can make an appointment to see for their health care needs. And expanding group practice-level public reporting ensures that more quality data are available to assist consumers with their decision making. We do appreciate, however, that not all specialties have a full complement of available quality measures specific to the work they do currently available through PQRS. As a result, we decided to make individual EP level Qualified Clinical Data Registry (QCDR) measures-both PQRS and non-PQRS measures--available for public reporting starting with 2015 data (79 FR 67774 through 67775). To further support the availability of quality measure data most relevant for all specialties, we propose to continue to make available for public reporting on Physician Compare all individual EP level QCDR PQRS and non-PQRS measure data that have been collected for at least a full year. In addition, we are now proposing to also make group practice level QCDR PQRS and non-PQRS measure data that have been collected for at least a full year available for public reporting. Previously, the PQRS program only included QCDR data at the individual EP level. In this proposed rule, CMS is proposing, under the PQRS, to expand QCDR data to be available to group practices as well. In this case, group practice refers to a group of 2 or more EPs billing under the same Tax Identification Number (TIN). We propose to publicly report these data annually in the year following the year the measures are reported. For both EP and group level measures, the measure performance rate will be represented on the Web site. We solicit comments on these proposals.

    The QCDR would be required to declare during its self-nomination if it plans to post data on its own Web site and allow Physician Compare to link to it or if the QDCR will provide data to us for public reporting on Physician Compare. After a QCDR declares a public reporting method, that decision is final for the reporting year. If a declaration is not made, the data would be considered available for public reporting on Physician Compare.

    f. Benchmarking

    We previously proposed (79 FR 40389) a benchmark that aligned with the Shared Savings Program ACO benchmark methodology finalized in the November 2011 Shared Savings Program final rule (76 FR 67898) and amended in the CY 2014 PFS final rule with comment period (78 FR 74759). Benchmarks are important to ensuring that the quality data published on Physician Compare are accurately understood. A benchmark will allow consumers to more easily evaluate the information published by providing a point of comparison between groups and between individuals. However, given shortcomings when trying to apply the Shared Savings Program methodology to the group practice or individual EP setting, this proposal was not finalized. We noted we would discuss more thoroughly potential benchmarking methodologies with our stakeholders and evaluate other programs' methodologies to identify the best possible option for a benchmark for Physician Compare (79 FR 67772). To accomplish this, we reached out to stakeholders, including specialty societies, consumer advocacy groups, physicians and other health care professionals, measure experts, and quality measure specialists, as well as other CMS Quality Programs. Based on this outreach and the recommendation of our Technical Expert Panel (TEP), we propose to publicly report on Physician Compare an item or measure-

    level benchmark derived using the Achievable Benchmark of Care (ABCTM) \4\ methodology annually based on the PQRS performance rates most recently available. For instance, in 2017 we would publicly report a benchmark derived from the 2016 PQRS performance rates. The specific measures the benchmark would be derived for would be determined once the data are available and analyzed. The benchmark would only be applied to those measures deemed valid and reliable and that are reported by enough EPs or group practices to produce a valid result (see 79 FR 67764 through 79 FR 67765 for a more detailed discussion regarding the types of analysis done to ensure data are suitable for public reporting). We solicit comments on this proposal.

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    \4\ Kiefe CI, Weissman NW, Allison JJ, Farmer R, Weaver M, Williams OD. Identifying achievable benchmarks of care: concepts and methodology. International Journal of Quality Health Care. 1998 Oct; 10(5):443-7.

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    ABCTM is a well-tested, data-driven methodology that allows us to account for all of the data collected for a quality measure, evaluate who the top performers are, and then use that to set a point of comparison for all of those groups or individual EPs who report the measure.

    ABCTM starts with the pared-mean, which is the mean of the best performers on a given measure for at least 10 percent of the patient population--not the population of reporters. To find the pared-

    mean, we will rank order physicians or groups (as appropriate per the measure being evaluated) in order from highest to lowest performance score. We will then subset the list by taking the best performers moving down from best to worst until we have selected enough reporters to represent 10 percent of all patients in the denominator across all reporters for that measure.

    We will derive the benchmark by calculating the total number of patients in the highest scoring subset receiving the intervention or the desired level of care, or achieving the desired outcome, and dividing this number by the total number of patients that were measured by the top performing doctors. This produces a benchmark that represents the best care provided to the top 10 percent of patients.

    An Example: A doctor reports which of her patients with diabetes have maintained their blood pressure at a healthy level. There are four steps to establishing the benchmark for this measure.

    (1) We look at the total number of patients with diabetes for all doctors who reported this diabetes measure.

    (2) We rank doctors that reported this diabetes measure from highest performance score to lowest performance score to identify the set of top doctors who treated at least 10 percent of the total number of patients with diabetes.

    (3) We count how many of the patients with diabetes who were treated by the top doctors also had blood pressure at a healthy level.

    (4) This number is divided by the total number of patients with diabetes

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    who were treated by the top doctors, producing the ABCTM benchmark.

    To account for low denominators, ABCTM calls for the calculation of an adjusted performance fraction (AFP), a Bayesian Estimator. The AFP is calculated by dividing the actual number of patients receiving the intervention or the desired level of care plus 1 by the total number of patients in the total sample plus 2. This ensures that very small sample sizes do not over influence the benchmark and allows all data to be included in the benchmark calculation. To ensure that a sufficient number of cases are included by mean performance percent, ABCTM provides a minimum sufficient denominator (MSD) for each performance level. Together this ensures that all cases are appropriately accounted for and adequately figured in to the benchmark.

    The ABCTM methodology for a publicly reported benchmark on Physician Compare would be based on the current year's data, so the benchmark would be appropriate regardless of the unique circumstances of data collection or the measures available in a given reporting year. We also propose to use the ABCTM methodology to generate a benchmark which can be used to systematically assign stars for the Physician Compare 5 star rating. ABCTM has been historically well received by the health care professionals and entities it is measuring because the benchmark represents quality while being both realistic and achievable; it encourages continuous quality improvement; and, it is shown to lead to improved quality of care.5 6 7

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    \5\ Kiefe CI, Weissman NW, Allison JJ, Farmer R, Weaver M, Williams OD. Identifying achievable benchmarks of care: concepts and methodology. International Journal of Quality Health Care. 1998 Oct; 10(5):443-7.

    \6\ Kiefe CI, Allison JJ, Williams O, Person SD, Weaver MT, Weissman NW. Improving Quality Improvement Using Achievable Benchmarks For Physician Feedback: A Randomized Controlled Trial. JAMA. 2001;285(22):2871-2879.

    \7\ Wessell AM, Liszka HA, Nietert PJ, Jenkins RG, Nemeth LS, Ornstein S. Achievable benchmarks of care for primary care quality indicators in a practice-based research network. American Journal of Medical Quality 2008 Jan-Feb;23(1):39-46.

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    To summarize, we propose to publicly report on Physician Compare an item or measure-level benchmark derived using the Achievable Benchmark of Care (ABCTM) methodology annually based on the PQRS performance rates most recently available (that is, in 2017 we would publicly report a benchmark derived from the 2016 PQRS performance rates), and use this benchmark to systematically assign stars for the Physician Compare 5 star rating. We solicit comments on this proposal.

    g. Patient Experience of Care Measures

    In the CY 2015 PFS final rule with comment period (79 FR 67547), we adopted a policy to publicly report patient experience data for all group practices of two or more EPs. Consumer testing shows that other patients' assessments of their experience resonate with consumers because it is important to them to hear about positive and negative experiences others have with physicians and other health care professionals. As a result, consumers report these patient experience data help them make an informed health care decision. Understanding the value consumers place on patient experience data and our commitment to reporting these data on Physician Compare, we propose to continue to make available for public reporting all patient experience data for all group practices of two or more EPs, who meet the specified sample size requirements and collect data via a CMS-specified certified CAHPS vendor, annually in the year following the year the measures are reported (for example, 2016 PQRS reported data will be included on the Web site in 2017). The patient experience data available that we propose to make available for public reporting are the CAHPS for PQRS measures, which include the CG-CAHPS core measures. For group practices, we propose to annually make available for public reporting a representation of the top box performance rate \8\ for these 12 summary survey measures:

    ---------------------------------------------------------------------------

    \8\ Top Box score refers to the most favorable response category for a given measure. If the measure has a scale of ``always,'' ``sometimes,'' ``never,'' the Top Box score is ``always'' if this represents the most favorable response. For the CAHPS for PQRS doctor rating, the Top Box score is a rating of 9 or 10.

    ---------------------------------------------------------------------------

    Getting Timely Care, Appointments, and Information.

    How Well Providers Communicate.

    Patient's Rating of Provider.

    Access to Specialists.

    Health Promotion & Education.

    Shared Decision Making.

    Health Status/Functional Status.

    Courteous and Helpful Office Staff.

    Care Coordination.

    Between Visit Communication.

    Helping You to Take Medication as Directed.

    Stewardship of Patient Resources.

    We solicit comments on this proposal.

    h. Downloadable Database

    (a) Addition of VM Information

    To further aid in transparency, we also propose to add new data elements to the Physician Compare downloadable database (https://data.medicare.gov/data/physician-compare). Currently, the downloadable database includes all quality information publicly reported on Physician Compare, including quality program participation, and all measures submitted and reviewed and found to be statistically valid and reliable. We propose to add to the Physician Compare downloadable database for group practices and individual EPs the 2018 VM quality tiers for cost and quality, based on the 2016 data, noting if the group practice or EP is high, low, or average on cost and quality per the VM. We also propose to include a notation of the payment adjustment received based on the cost and quality tiers, and an indication if the individual EP or group practice was eligible to but did not report quality measures to CMS. The profile pages on Physician Compare are meant to provide information to average Medicare consumers that can help them identify quality health care and choose a quality clinician, while this database is geared toward health care professionals, industry insiders, and researchers who are more able to accurately use more complex data. Therefore, adding this information to the downloadable database promotes transparency and provides useful data to the public while we conduct consumer testing to ensure VM data beyond the indication for an upward adjustment discussed above can be packaged and explained in such a way that it is accurately interpreted, understood, and useful to average consumers. We solicit comments on this proposal.

    (b) Addition of Utilization Data

    In addition, we propose to add utilization data to the Physician Compare downloadable database. Utilization data is information generated from Medicare Part B claims on services and procedures provided to Medicare beneficiaries by physicians and other health care professionals; and are currently available at (http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/Physician-and-Other-Supplier.html ). It provides counts of services and procedures rendered by health care professionals by Healthcare Common Procedure Coding System (HCPCS) code. Under section 104(e) of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), Pub. L. 114-10, Sec. 104, signed into law April 16, 2015; beginning with 2016, the Secretary shall integrate utilization data information on Physician Compare. This

    Page 41814

    section of the law discusses data that can help empower people enrolled in Medicare by providing access to information about physician services. These data are very useful to the health care industry and to health care researchers and other stakeholders who can accurately interpret these data and use them in meaningful analysis. These data are less immediately useable in their raw form by the average Medicare consumer. As a result, we propose that the data be added to the downloadable database versus the consumer-focused Web site profile pages. Including these data in the Physician Compare downloadable database provides transparency without taking away from the information of most use to consumers on the main Web site. We solicit comments on this proposal.

    (i) Board Certification

    Finally, we propose adding additional Board Certification information to the Physician Compare Web site. Board Certification is the process of reviewing and certifying the qualifications of a physician or other health care professional by a board of specialists in the relevant field. We currently include American Board of Medical Specialties (ABMS) data as part of individual EP profiles on Physician Compare. We appreciate that there are additional, well respected boards that are not included in the ABMS data currently available on Physician Compare that represent EPs and specialties represented on the Web site. Such board certification information is of interest to consumers as it provides additional information to use to evaluate and distinguish between EPs on the Web site, which can help in making an informed health care decision. The more data of immediate interest that is included on Physician Compare, the more users will come to the Web site and find quality data that can help them make informed decisions. Specifically, we are now proposing to add to the Web site board certification information from the American Board of Optometry (ABO) and American Osteopathic Association (AOA). Please note we are not endorsing any particular boards. These two specific boards showed interest in being added to the Web site and have demonstrated that they have the data to facilitate inclusion of this information on the Web site. These two boards also fill a gap, as the ABMS does not certify Optometrists and only certain types of DOs are covered by AMBS Osteopathic certification. In general, we will review interest from boards as it is brought to our attention, and if the necessary data are available and appropriate arrangements and agreements can be made to share the needed information with Physician Compare, additional board information could be added to the Web site in future. At this time, however, we are specifically proposing to include ABO and AOA Board Certification information on Physician Compare. We solicit comments on this proposal.

    We solicit comments on all proposals. Increasing the measures and data elements for public reporting on Physician Compare at both the individual and group level will help accomplish the Web site's twofold purpose:

    To provide more information for consumers to encourage informed patient choice.

    To create explicit incentives for physicians to maximize performance.

    Table 19 summarizes the Physician Compare measure and participation data proposals detailed in this section.

    Table 19--Summary of Proposed Measure and Participation Data for Public Reporting

    ----------------------------------------------------------------------------------------------------------------

    Proposed quality

    Data collection year * Publication year Data type Reporting mechanism measures and data for

    * public reporting

    ----------------------------------------------------------------------------------------------------------------

    2016..................... 2017 PQRS, PQRS, GPRO, Web Interface, EHR, Include an indicator for

    EHR, and Million Registry, Claims. satisfactory reporters

    Hearts. under PQRS,

    participants in the EHR

    Incentive Program, and

    EPs who satisfactorily

    report the

    Cardiovascular

    Prevention measures

    group proposed under

    PQRS in support of

    Million Hearts.

    2016..................... 2018 PQRS, PQRS, GPRO... Web Interface, EHR, Include an indicator for

    Registry, Claims. individual EPs and

    group practices who

    receive an upward

    adjustment for the VM.

    2016..................... 2017 PQRS, GPRO......... Web Interface, EHR, All PQRS GPRO measures

    Registry. reported via the Web

    Interface, EHR, and

    registry that are

    available for public

    reporting for group

    practices of 2 or more

    EPs.

    Publicly report an item-

    level benchmark, as

    appropriate.

    2016..................... 2017 ACO................ Web Interface, All measures reported by

    Survey Vendor Shared Savings Program

    Claims. ACOs, including CAHPS

    for ACOs.

    2016..................... 2017 CAHPS for PQRS..... CMS-Specified All CAHPS for PQRS

    Certified CAHPS measures for groups of

    Vendor. 2 or more EPs who meet

    the specified sample

    size requirements and

    collect data via a CMS-

    specified certified

    CAHPS vendor.

    2016..................... 2017 PQRS............... Registry, EHR, or All PQRS measures for

    Claims. individual EPs

    collected through a

    registry, EHR, or

    claims.

    Publicly report an item-

    level benchmark, as

    appropriate.

    2016..................... 2017 QCDR data.......... QCDR............... All individual EP and

    group practice QCDR

    measures.

    2016..................... 2017 Utilization data... Claims............. Utilization data for

    individual EPs in the

    downloadable database.

    2016..................... 2017 PQRS, PQRS, GPRO... Web Interface, EHR, The following data for

    Registry, Claims. group practices and

    individual EPs in the

    downloadable database:

    The VM quality

    tiers for cost and

    quality, noting if the

    group practice or EP is

    high, low, or neutral

    on cost and quality per

    the VM.

    A notation of

    the payment adjustment

    received based on the

    cost and quality tiers.

    An indication

    if the individual EP or

    group practice was

    eligible to but did not

    report quality measures

    to CMS.

    ----------------------------------------------------------------------------------------------------------------

    * Note that these data are proposed to be reported annually. The table only provides the first year in which

    these proposals would begin on an annual basis, and such dates also serve to illustrate the data collection

    year in relation to the publication year. Therefore, after 2016, 2017 data would be publicly reported in 2018,

    2018 data would be publicly reported in 2019, etc.

    Page 41815

    4. Seeking Public Comment for Possible Future Rulemaking

    a. Quality Measures

    In addition to these proposals, we seek comment on several new data elements for possible inclusion on the individual EP and group profile pages of Physician Compare. In future years, we will consider expanding public reporting to include additional quality measures. We know there are gaps in the measures currently available for public reporting on Physician Compare. Understanding this, we would like to hear from stakeholders about the types of quality measures that will help us fill these gaps and meet the needs of consumers and stakeholders. Therefore, we seek comment on potential measures that would benefit future public reporting on Physician Compare. We are working to identify possible data sources and we seek comment on the measure concepts, as well as potential specific measures of interest. The quality measures that would be considered for future posting on Physician Compare are those that have been comprehensively vetted and tested, and are trusted by the physician community.

    b. Medicare Advantage

    We also seek comment on adding Medicare Advantage information to Physician Compare individual EP and group practice profile pages. Specifically, we are seeking comment on adding information on the relevant EP and group practice profile pages about which Medicare Advantage health plans the EP or group accepts and making this information a link to more information about that plan on the Medicare.gov Plan Finder Web site. An increasing number of Medicare clinicians provide services via Medicare Advantage. Medicare Advantage quality data is reported via Plan Finder at the plan level. As a result, physicians and other health care professionals who participate in Medicare Advantage do not have quality measure data available for public reporting on Physician Compare. Adding a link between Physician Compare clinicians participating in Medicare Advantage plans and the associated quality data available for those plans on Plan Finder ensures that consumers have access to all of the quality data available to make an informed health care decision.

    c. Value Modifier

    We also seek comment on including additional VM cost and quality data on Physician Compare. Specifically, we seek comment on including in future years an indicator for a downward and neutral VM adjustment on group practice and individual EP profile pages. We also seek comment on including the VM quality composite or other VM quality performance data on Physician Compare group practice and individual EP profile pages and/or the Physician Compare downloadable database. Similarly, we seek comment on including the VM cost composite or other VM cost measure data on Physician Compare group practice and individual EP profile pages and/or the downloadable database. These VM quality and cost measures ultimately help determine the payment adjustment and are an indication of whether the individual or group is meeting the Affordable Care Act goals of improving quality while lowering cost. Specifically, including this cost data is consistent with the section 10331(a)(2) of the Affordable Care Act as it is an assessment of efficiency. However, these data are complex and we need time to establish the best method for public reporting and to ensure this information is accurately understood and interpreted by consumers. Therefore, we only seek comment at this time.

    d. Open Payments Data

    We currently make Open Payments data available at http://www.cms.gov/openpayments/. Consumer testing has indicated that these data are of great interest to consumers. Consumers have indicated that this level of transparency is important to them and access to this information on Physician Compare increases their ability to find and evaluate the information. We seek comment about including Open Payments data on individual EP profile pages. Although these data are already publicly available, consumer testing has also indicated that additional context, wording, and data display considerations can help consumers better understand the information. We are now seeking comment on adding these data to Physician Compare; to the extent it is feasible and appropriate. Prior to considering a formal proposal, we can continue to test these data with consumers to establish the context and framing needed to best ensure these data are accurately understood and presented in a way that assists decision making. Therefore, we only seek comment at this time.

    e. Measure Stratification

    Finally, we seek comment on including individual EP and group practice-level quality measure data stratified by race, ethnicity, and gender on Physician Compare, if feasible and appropriate (i.e. statistically appropriate, etc.). By stratification we mean that we will report quality measures for each group of a given category. For example, if we were to report a measure for blood pressure control stratified by sex, we would report a performance score for women and one for men. We also seek comment on potential quality measures, including composite measures, for future postings on Physician Compare that could help consumers and stakeholders monitor trends in health equity. Inclusion of data stratified by race and ethnicity and gender, as well as the inclusion of other measures of health equity would help ensure that HHS is beginning to work to fulfill one of the Affordable Care Act goals of reporting data on race, ethnicity, sex, primary language, and disability status through public postings on HHS Web sites and other dissemination strategies (see ACA Section 4302).

    We are specifically seeking comment on these issues. Any data recommended in these areas for public disclosure on Physician Compare would be addressed through separate notice-and-comment rulemaking.

    I. Physician Payment, Efficiency, and Quality Improvements--Physician Quality Reporting System

    This section contains the proposed requirements for the Physician Quality Reporting System (PQRS). The PQRS, as set forth in sections 1848(a), (k), and (m) of the Act, is a quality reporting program that provides incentive payments (which ended in 2014) and payment adjustments (which began in 2015) to eligible professionals (EPs) and group practices based on whether they satisfactorily report data on quality measures for covered professional services furnished during a specified reporting period or to individual EPs based on whether they satisfactorily participate in a qualified clinical data registry (QCDR). Please note that section 101(b)(2)(A) of the Medicare Access and CHIP Reauthorization Act of 2015 (Pub. L. 114-10, enacted on April 16, 2015) (MACRA) amends section 1848(a)(8)(A) by striking ``2015 or any subsequent year'' and inserting ``each of 2015 through 2018.'' This amendment authorizes the end of the PQRS in 2018 and beginning of a new program, which may incorporate aspects of the PQRS, the Merit-based Incentive Payment System (MIPS).

    The proposed requirements primarily focus on our proposals related to the 2018 PQRS payment adjustment, which will be based on an EP's or a group practice's reporting of quality measures

    Page 41816

    data during the 12-month calendar year reporting period occurring in 2016 (that is, January 1 through December 31, 2016). Please note that, in developing these proposals, we focused on aligning our requirements, to the extent appropriate and feasible, with other quality reporting programs, such as the Medicare Electronic Health Record (EHR) Incentive Program for EPs, the Physician Value-Based Payment Modifier (VM), and the Medicare Shared Savings Program. In previous years, we have made various strides in our ongoing efforts to align the reporting requirements in CMS' quality reporting programs to reduce burden on the EPs and group practices that participate in these programs. We continue to focus on alignment as we develop our proposals for the 2018 PQRS payment adjustment below.

    In addition, please note that, in our quality programs, we are beginning to emphasize the reporting of certain types of measures, such as outcome measures, as well as measures within certain NQS domains. Indeed, in its March 2015 report (available at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=79068) the Measure Applications Partnership (MAP) has suggested that CMS place an emphasis on higher quality measures, such as functional outcome measures. For example, in the PQRS, we have placed an emphasis on the reporting of the Consumer Assessment of Healthcare Providers and Systems (CAHPS) for PQRS survey and cross-cutting measures that promote the health of larger populations and that are applicable to a larger number of patients. As discussed further in this section, we are proposing to require the reporting of the CAHPS for PQRS survey for groups of 25 or more EPs who register to participate in the PQRS Group Practice Reporting Option (GPRO) and select the GPRO web interface as the reporting mechanism. In addition, we are proposing to continue to require the reporting of at least 1 applicable cross-cutting measure if an EP sees at least 1 Medicare patient. Furthermore, when reporting measures via a QCDR, we emphasize the reporting of outcome measures, as well as resource use, patient experience of care, efficiency/appropriate use, or patient safety measures.

    The PQRS regulations are specified in Sec. 414.90. The program requirements for the 2007 through 2014 PQRS incentives and the 2015 through 2017 PQRS payment adjustments that were previously established, as well as information on the PQRS, including related laws and established requirements, are available at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/index.html. In addition, the 2013 PQRS and eRx Experience Report, which provides information about EP participation in PQRS, is available for download at http://cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2013_PQRS_eRx_Experience_Report_zip.zip.

    1. The Definition of EP for Purposes of Participating in the PQRS

    CMS implemented the first PQRS payment adjustment on January 1, 2015. Specifically, EPs who did not satisfactorily report data on quality measures during the 12-month calendar year reporting period occurring in 2013 are receiving a 1.5 percent negative adjustment during CY 2015 on all of the EPs' Part B covered professional services under the Medicare Physician Fee Schedule (PFS). The 2015 PQRS payment adjustment applies to payments for all of the EPs' Part B covered professional services furnished under the PFS. We received many questions surrounding who must participate in the PQRS to avoid the PQRS payment adjustment. As such, we seek to clarify here who is required to participate in the PQRS for purposes of the payment adjustments in this rule.

    Please note that there are no hardship or low volume exemptions for the PQRS payment adjustment. All EPs who furnish covered professional services must participate in the PQRS each year by meeting the criteria for satisfactory reporting--or, in lieu of satisfactory reporting, satisfactory participation in a QCDR--to avoid the PQRS payment adjustments.

    The PQRS payment adjustment applies to EPs who furnish covered professional services. The definition of an EP for purposes of participating in the PQRS is specified in section 1848(k)(3)(B) of the Act. Specifically, the term ``eligible professional'' (EP) means any of the following: (i) A physician; (ii) a practitioner described in section 1842(b)(18)(C); (iii) a physical or occupational therapist or a qualified speech-language pathologist; or (iv) beginning with 2009, a qualified audiologist (as defined in section 1861(ll)(3)(B)). The term ``covered professional services'' is defined in section 1848(k)(3)(A) of the Act to mean services for which payment is made under, or is based on, the Medicare PFS established under section 1848 and which are furnished by an EP.

    EPs in Critical Access Hospitals Billing under Method II (CAH-IIs): We note that EPs in critical access hospitals billing under Method II (CAH-IIs) were previously not able to participate in the PQRS. Due to a change we made in the manner in which EPs in CAH-IIs are reimbursed by Medicare, it is now feasible for EPs in CAH-IIs to participate in the PQRS. EPs in CAH-IIs may participate in the PQRS using ALL reporting mechanisms available, including the claims-based reporting mechanism.

    EPs Who Practice in Rural Health Clinics (RHCs) and/or Federally Qualified Health Centers (FQHCs): Services furnished at RHCs and/or FQHCs for which payment is not made under, or based on, the Medicare PFS, or which are not furnished by an EP, are not subject to the PQRS negative payment adjustment. With respect to EPs who furnish covered professional services at RHCs and/or FQHCs that are paid under the Medicare PFS, we note that we are currently unable to assess PQRS participation for these EPs due to the way in which these EPs bill for services under the PFS. Therefore, EPs who practice in RHCs and/or FQHCs would not be subject to the PQRS payment adjustment.

    EPs Who Practice in Independent Diagnostic Testing Facilities (IDTFs) and Independent Laboratories (ILs): We note that due to the way IDTF and IL suppliers and their employee EPs are enrolled with Medicare and claims are submitted for services furnished by these suppliers and billed by the IDTF or IL, we are unable to assess PQRS participation for these EPs. Therefore, claims submitted for services performed by EPs who perform services as employee of, or on a reassignment basis to, IDTFs or ILs would not be subject to the PQRS payment adjustment.

    2. Requirements for the PQRS Reporting Mechanisms

    The PQRS includes the following reporting mechanisms: Claims; qualified registry; EHR (including direct EHR products and EHR data submission vendor products); the GPRO web interface; certified survey vendors, for CAHPS for PQRS survey measures; and the QCDR. Under the existing PQRS regulation, Sec. 414.90(h) through (k) govern which reporting mechanisms are available for use by individuals and group practices for the PQRS incentive and payment adjustment. This section contains our proposals to change the QCDR and qualified registry reporting mechanisms. Please note that we are not proposing to make changes to the other PQRS reporting mechanisms.

    One of our goals, as indicated in the Affordable Care Act, is to report data on

    Page 41817

    race, ethnicity, sex, primary language, and disability status. A necessary step toward fulfilling this mission is the collection and reporting of quality data, stratified by race, ethnicity, sex, primary language, and disability status. The agency intends to require the collection of these data elements within each of the PQRS reporting mechanisms. Although we are not proposing in this proposed rule to require the collection of these data elements, we are seeking comments regarding the facilitators and obstacles providers and vendors may face in collecting and reporting these attributes. Additionally, we seek comments on preference for a phased-in approach, perhaps starting with a subset of measures versus a requirement across all possible measures and mechanisms with an adequate timeline for implementation.

    a. Proposed Changes to the Requirements for the QCDR

    We are required, under section 1848(m)(3)(E)(i) of the Act, to establish requirements for an entity to be considered a QCDR. Such requirements must include a requirement that the entity provide the Secretary with such information, at such times, and in such manner as the Secretary determines necessary to carry out this subsection. Section 1848(m)(3)(E)(iv) of the Act, as added by section 601(b)(1)(B) of the American Taxpayer Relief Act of 2012 (ATRA), requires CMS to consult with interested parties in carrying out this provision. Below, we seek to clarify issues related to QCDR self-nomination, as well as propose a change related to the requirements for an entity to become a QCDR.

    Who May Apply to Self-Nominate to Become a QCDR: We have received many questions related to what entities may participate in the PQRS as a QCDR. We note that Sec. 414.90(b) defines a QCDR as a CMS-approved entity that has self-nominated and successfully completed a qualification process showing that it collects medical and/or clinical data for the purpose of patient and disease tracking to foster improvement in the quality of care provided to patients. A QCDR must perform the following functions:

    Submit quality measures data or results to CMS for purposes of demonstrating that, for a reporting period, its EPs have satisfactorily participated in PQRS. A QCDR must have in place mechanisms for the transparency of data elements and specifications, risk models, and measures.

    Submit to CMS, for purposes of demonstrating satisfactory participation, quality measures data on multiple payers, not just Medicare patients.

    Provide timely feedback, at least four times a year, on the measures at the individual participant level for which the QCDR reports on the EP's behalf for purposes of the individual EP's satisfactory participation in the QCDR.

    Possess benchmarking capacity that compares the quality of care an EP provides with other EPs performing the same or similar functions.

    We established further details regarding the requirements to become a QCDR in the CYs 2014 and 2015 PFS final rules (78 FR 74467 through 74473 and 79 FR 67779 through 67782). Please note that the requirements we established were not meant to prohibit entities that meet the basic definition of a QCDR outlined in Sec. 414.90(b) from self-nominating to participate in the PQRS as a QCDR. As long as the entity meets the basic definition of a QCDR provided in Sec. 414.90(b), we encourage the entity to self-nominate to become a QCDR.

    Self-Nomination Period: We established a deadline for an entity becoming a QCDR to submit a self-nomination statement--specifically, self-nomination statements must be received by CMS by 5:00 p.m., eastern standard time (e.s.t.), on January 31 of the year in which the clinical data registry seeks to be qualified (78 FR 74473). However, we did not specify when the QCDR self-nomination period opens. We received feedback from entities that believed they needed more time to self-

    nominate. Typically, we open the self-nomination period on January 1 of the year in which the clinical data registry seeks to be qualified. While it is not technically feasible for us to extend the self-

    nomination deadline past January 31, we will open the QCDR self-

    nomination period on December 1 of the prior year to allow more time for entities to self-nominate. This would provide entities with an additional month to self-nominate.

    Proposed Establishment of a QCDR Entity: In the CY 2014 PFS final rule (78 FR 74467), we established the requirement that, for an entity to become qualified for a given year, the entity must be in existence as of January 1 the year prior to the year for which the entity seeks to become a QCDR (for example, January 1, 2013, to be eligible to participate for purposes of data collected in 2014). We established this criterion to ensure that an entity seeking to become a QCDR is well-established prior to self-nomination. We have received feedback from entities that this requirement is overly burdensome, as it delays entities otherwise fully capable of becoming a QCDR from participating in the PQRS. To address these concerns while still ensuring that an entity seeking to become a QCDR is well-established, beginning in 2016, we propose to modify this requirement to require the following: For an entity to become qualified for a given year, the entity must be in existence as of January 1 the year for which the entity seeks to become a QCDR (for example, January 1, 2016, to be eligible to participate for purposes of data collected in 2016). We invite public comment on this proposal.

    Attestation Statements for QCDRs Submitting Quality Measures Data during Submission: In the CY 2014 PFS final rule, to ensure that the data provided by the QCDR is correct, we established the requirement that QCDRs provide CMS a signed, written attestation statement via email which states that the quality measure results and any and all data, including numerator and denominator data, provided to CMS are accurate and complete (78 FR 74472). In lieu of submitting an attestation statement via email, beginning in 2016, we propose to allow QCDRs to attest during the data submission period that the quality measure results and any and all data including numerator and denominator data provided to CMS will be accurate and complete using a web-based check box mechanism available at https://www.qualitynet.org/portal/server.pt/community/pqri_home/212. We believe it is less burdensome for QCDRs to check a box acknowledging and attesting to the accuracy of the data they provide, rather than having to email a statement to CMS. Please note that, if this proposal is finalized, QCDRs will no longer be able to submit this attestation statement via email. We invite public comment on this proposal.

    In addition, we noted in the CY 2015 PFS final rule (79 FR 67903) that entities wishing to become QCDRs would have until March 31 of the year in which it seeks to become a QCDR to submit measure information the entity intends to report for the year, which included submitting the measure specifications for non-PQRS measures the QCDR intends to report for the year. However, we have experienced issues related to the measures data we received during the 2013 reporting year. These issues prompt us to more closely analyze the measures for which an entity intends to report as a QCDR. Therefore, so that we may vet and analyze these vendors to determine whether they are fully ready to be qualified to participate in the PQRS as a QCDR, we propose to require that all

    Page 41818

    other documents that are necessary to analyze the vendor for qualification be provided to CMS at the time of self-nomination, that is, by no later than January 31 of the year in which the vendor intends to participate in the PQRS as a QCDR (that is, January 31, 2016 to participate as a QCDR for the reporting periods occurring in 2016). This includes, but is not limited to, submission of the vendor's data validation plan as well as the measure specifications for the non-PQRS measures the entity intends to report. In addition, please note that after the entity submits this information on January 31, it cannot later change any of the information it submitted to us for purposes of qualification. For example, once an entity submits measure specifications on non-PQRS measures, it cannot later modify the measures specifications the entity submitted. Please note that this does not prevent the entity from providing supplemental information if requested by CMS.

    Data Validation Requirements: A validation strategy details how the qualified registry will determine whether EPs and GPRO group practices have submitted data accurately and satisfactorily on the minimum number of their eligible patients, visits, procedures, or episodes for a given measure. Acceptable validation strategies often include such provisions as the qualified registry being able to conduct random sampling of their participant's 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. The current guidance on validation strategy is available at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2015_RegistryVendorCriteria.pdf. In analyzing our requirements, we believe adding the following additional requirements will help mitigate issues that may occur when collecting, calculating, and submitting quality measures data to CMS. Therefore, we propose that, beginning in 2016, a QCDR must provide the following information to CMS at the time of self-nomination to ensure that QCDR data is valid:

    Organization Name (Specify Sponsoring Organization name and qualified registry name if the two are different).

    Program Year.

    Vendor Type (for example, qualified registry).

    Provide the method(s) by which the entity obtains data from its customers: claims, web-based tool, practice management system, EHR, other (please explain). If a combination of methods (Claims, Web Based Tool, Practice Management System, EHR, and/or other) is utilized, please state which method(s) the entity utilizes to collect reporting numerator and denominator data.

    Indicate the method the entity will use to verify the accuracy of each Tax Identification Number (TIN) and National Provider Identifier's (NPI) it is intending to submit (that is, National Plan and Provider Enumeration System (NPPES), CMS claims, tax documentation).

    Describe the method that the entity will use to accurately calculate both reporting rates and performance rates for measures and measures groups based on the appropriate measure type and specification. For composite measures or measures with multiple performance rates, the entity must provide us with the methodology the entity uses for these composite measures and measures with multiple performance rates.

    Describe the process that the entity will use for completion of a randomized audit of a subset of data prior to the submission to CMS. Periodic examinations may be completed to compare patient record data with submitted data and/or ensure PQRS measures were accurately reported based on the appropriate Measure Specifications (that is, accuracy of numerator, denominator, and exclusion criteria).

    If applicable, provide information on the entity's sampling methodology. For example, it is encouraged that 3 percent of the TIN/NPIs be sampled with a minimum sample of 10 TIN/NPIs or a maximum sample of 50 TIN/NPIs. For each TIN/NPI sampled, it is encouraged that 25 percent of the TIN/NPI's patients (with a minimum sample of 5 patients or a maximum sample of 50 patients) should be reviewed for all measures applicable to the patient.

    Define a process for completing a detailed audit if the qualified registry's validation reveals inaccuracy and describe how this information will be conveyed to CMS.

    QCDRs must perform the validation outlined in the validation strategy and send evidence of successful results to CMS for data collected in the reporting periods occurring in 2016. The Data Validation Execution Report must be sent via email to the QualityNet Help Desk at Qnetsupport@sdps.org by 5:00 p.m. ET on June 30, 2016. The email subject should be ``PY2015 Qualified Registry Data Validation Execution Report.''

    Submission of Quality Measures Data for Group Practices: Section 101(d)(1)(B) of the MACRA amends section 1848(m)(3)(D) of the Act by inserting ``and, for 2016 and subsequent years, subparagraph (A) or (C)'' after ``subparagraph (A)''. This change authorizes CMS to create an option for EPs participating in the GPRO to report quality measures via a QCDR. As such, in addition to being able to submit quality measures data for individual EPs, we propose that QCDRs also have the ability to submit quality measures data for group practices.

    b. Proposed Changes to the Requirements for Qualified Registries

    Attestation Statements for Registries Submitting Quality Measures Data: In the CY 2013 PFS final rule, we finalized the following requirement to ensure that the data provided by a registry is correct: We required that the registry provide CMS a signed, written attestation statement via mail or email which states that the quality measure results and any and all data including numerator and denominator data provided to CMS are accurate and complete for each year the registry submits quality measures data to CMS (77 FR 69180). In lieu of submitting an attestation statement via email or mail, beginning in 2016, we propose to allow registries to attest during the submission period that the quality measure results and any and all data including numerator and denominator data provided to CMS will be accurate and complete using a web-based check box mechanism available at https://www.qualitynet.org/portal/server.pt/community/pqri_home/212. We believe it is less burdensome for registries to check a box acknowledging and attesting to the accuracy of the data they provide, rather than having to email a statement to CMS. Please note that, if this proposal is finalized, qualified registries will no longer be able to submit this attestation statement via email or mail. We invite public comment on this proposal.

    In addition, so that we may vet and analyze these vendors to determine whether they are fully ready to be qualified to participate in the PQRS as a qualified registry, we propose to require that all other documents that are necessary to analyze the vendor for qualification be provided to CMS at the time of self-nomination, that is, by no later than January 31 of the year in which the vendor intends to participate in the PQRS as a qualified registry (that is, January 31, 2016 to participate as a qualified registry for the reporting periods occurring in 2016). This

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    includes, but is not limited to, submission of the vendor's data validation plan. Please note that this does not prevent the entity from providing supplemental information if requested by CMS.

    Data Validation Requirements: A validation strategy details how the qualified registry will determine whether EPs and GPRO group practices have submitted accurately and satisfactorily on the minimum number of their eligible patients, visits, procedures, or episodes for a given measure. Acceptable validation strategies often include such provisions as the qualified registry being able to conduct random sampling of their participant's 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. The current guidance on validation strategy is available at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2015_RegistryVendorCriteria.pdf. In analyzing our requirements, we believe adding the following additional requirements will help mitigate issues that may occur when collecting, calculating, and submitting quality measures data to CMS. Therefore, we propose that, beginning in 2016, a QCDR must provide the following information to CMS at the time of self-nomination to ensure that data submitted by a qualified registry is valid:

    Organization Name (specify the sponsoring entity name and qualified registry name if the two are different).

    Program Year.

    Vendor Type (for example, qualified registry).

    Provide the method(s) by which the entity obtains data from its customers: claims, web-based tool, practice management system, EHR, other (please explain). If a combination of methods (Claims, Web Based Tool, Practice Management System, EHR, and/or other) is utilized, please state which method(s) the entity utilizes to collect its reporting numerator and denominator data.

    Indicate the method the entity will use to verify the accuracy of each TIN and NPI it is intending to submit (that is, NPPES, CMS claims, tax documentation).

    Describe how the entity will verify that EPs or group practices report on at least 1 measure contained in the cross-cutting measure set if the EP or group practice sees at least 1 Medicare patient in a face-to-face encounter. Describe how the entity will verify that the data provided is complete and contains the entire cohort of data.

    Describe the method that the entity will use to accurately calculate both reporting rates and performance rates for measures and measures groups based on the appropriate measure type and specification.

    Describe the method the entity will use to verify that only the measures in the applicable PQRS Claims and Registry Individual Measure Specifications (that is, the 2016 PQRS Claims and Registry Individual Measure Specifications for data submitted for reporting periods occurring in 2016) and applicable PQRS Claims and Registry Measures Groups Specifications (that is, the 2016 PQRS Claims and Registry Measures Groups Specifications for data submitted for reporting periods occurring in 2016) are utilized for submission.

    Describe the process that the entity will use for completion of a randomized audit of a subset of data prior to the submission to CMS. Periodic examinations may be completed to compare patient record data with submitted data and/or ensure PQRS measures were accurately reported based on the appropriate Measure Specifications (that is, accuracy of numerator, denominator, and exclusion criteria).

    If applicable, provide information on the entity's sampling methodology. For example, it is encouraged that 3 percent of the TIN/NPIs be sampled with a minimum sample of 10 TIN/NPIs or a maximum sample of 50 TIN/NPIs. For each TIN/NPI sampled, it is encouraged that 25 percent of the TIN/NPI's patients (with a minimum sample of 5 patients or a maximum sample of 50 patients) should be reviewed for all measures applicable to the patient.

    Define a process for completing a detailed audit if the qualified registry's validation reveals inaccuracy and describe how this information will be conveyed to CMS.

    Registries must maintain the ability to randomly request and receive documentation from providers to verify accuracy of data. Registries must also provide CMS access to review the Medicare beneficiary data on which the applicable PQRS registry-based submissions are based or provide to CMS a copy of the actual data (if requested for validation purposes).

    Qualified registries must perform the validation outlined in the validation strategy and send evidence of successful results to CMS for data collected for the applicable reporting periods. The Data Validation Execution Report must be sent via email to the QualityNet Help Desk at Qnetsupport@sdps.org by 5:00 p.m. ET on June 30 of the year in which the reporting period occurs (that is, June 30, 2016 for reporting periods occurring in 2016). The email subject should be ``PY2015 Qualified Registry Data Validation Execution Report.''

    c. Auditing of Entities Submitting PQRS Quality Measures Data

    We are in the process of auditing PQRS participants, including vendors who submit quality measures data. We believe it is essential for vendors to corporate with this audit process. In order to ensure that CMS has adequate information to perform an audit of a vendor, we are proposing that, beginning in 2016, any vendor submitting quality measures data for the PQRS (for example, entities participating the PQRS as a qualified registry, QCDR, direct EHR, or DSV) comply with the following requirements:

    The vendor make available to CMS the contact information of each EP on behalf of whom it submits data. The contact information will include, at a minimum, the EP practice's phone number, address, and, if applicable email.

    The vendor must retain all data submitted to CMS for the PQRS program for a minimum of seven years.

    We invite public comment on these proposals.

    3. Proposed Criteria for the Satisfactory Reporting for Individual EPs for the 2018 PQRS Payment Adjustment

    Section 1848(a)(8) of the Act, as added by section 3002(b) of the Affordable Care Act, provides that for covered professional services furnished by an EP during 2015 or any subsequent year, if the EP does not satisfactorily report data on quality measures for covered professional services for the quality reporting period for the year, the fee schedule amount for services furnished by such professional during the year (including the fee schedule amount for purposes of determining a payment based on such amount) shall be equal to the applicable percent of the fee schedule amount that would otherwise apply to such services. For 2016 and subsequent years, the applicable percent is 98.0 percent.

    a. Proposed Criterion for the Satisfactory Reporting of Individual Quality Measures via Claims and Registry for Individual EPs for the 2018 PQRS Payment Adjustment

    We finalized the following criteria for satisfactory reporting for the submission of individual quality measures via

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    claims and registry for 2017 PQRS payment adjustment (see Table 50 at 79 FR 67796): For the applicable 12-month reporting period, the EP would report at least 9 measures, covering at least 3 of the NQS domains, OR, if less than 9 measures apply to the EP, report on each measure that is applicable, AND report each measure for at least 50 percent of the Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measures with a 0 percent performance rate would not be counted. For an EP who reports fewer than 9 measures covering less than 3 NQS domains via the claims- or registry-based reporting mechanism, the EP would be subject to the measure application validity (MAV) process, which would allow us to determine whether the EP should have reported quality data codes for additional measures. To meet the criteria for the 2017 PQRS payment adjustment, we added the following requirement: Of the measures reported, if the EP sees at least 1 Medicare patient in a face-to-face encounter, as we propose to define that term below, the EP would report on at least 1 measure contained in the PQRS cross-cutting measure set.

    To be consistent with the satisfactory reporting criterion we finalized for the 2017 PQRS payment adjustment, we are proposing to amend Sec. 414.90(j) to specify the same criterion for individual EPs reporting via claims and registry for the 2018 PQRS payment adjustment. Specifically, for the 12-month reporting period for the 2018 PQRS payment adjustment, the EP would report at least 9 measures, covering at least 3 of the NQS domains AND report each measure for at least 50 percent of the EP's Medicare Part B FFS patients seen during the reporting period to which the measure applies. Of the measures reported, if the EP sees at least 1 Medicare patient in a face-to-face encounter, as we propose to define that term below, the EP would report on at least 1 measure contained in the PQRS cross-cutting measure set. If less than 9 measures apply to the EP, the EP would report on each measure that is applicable, AND report each measure for at least 50 percent of the Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measures with a 0 percent performance rate would not be counted.

    For what defines a ``face-to-face'' encounter, for purposes of proposing to require reporting of at least 1 cross-cutting measure, we propose to determine whether an EP had a ``face-to-face'' encounter by assessing whether the EP billed for services under the PFS that are associated with face-to-face encounters, such as whether an EP billed general office visit codes, outpatient visits, and surgical procedures. We would not include telehealth visits as face-to-face encounters for purposes of the proposal requiring reporting of at least 1 cross-

    cutting measure. For our current list of face-to-face encounter codes for the requirement to report a cross-cutting measure, please see http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/FacetoFace_Encounter_CodeList_01302015.zip.

    In addition, we understand that there may be instances where an EP may not have at least 9 measures applicable to an EP's practice. In this instance, like the criterion we finalized for the 2017 payment adjustment (see Table 50 at 79 FR 67796), an EP reporting on less than 9 measures would still be able to meet the satisfactory reporting criterion via claims and registry if the EP reports on each measure that is applicable to the EP's practice. If an EP reports on less than 9 measures, the EP would be subject to the MAV process, which would allow us to determine whether an EP should have reported quality data codes for additional measures. In addition, the MAV process will also allow us to determine whether an EP should have reported on any of the PQRS cross-cutting measures. The MAV process we are proposing to implement for claims and registry is the same process that was established for reporting periods occurring in 2015 for the 2017 PQRS payment adjustment. For more information on the claims and registry MAV process, please visit the measures section of the PQRS Web site at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/MeasuresCodes.html.

    We seek public comment on our proposed satisfactory reporting criteria for individual EPs reporting via claims or registry for the 2018 PQRS payment adjustment.

    b. Proposed Criterion for Satisfactory Reporting of Individual Quality Measures via EHR for Individual EPs for the 2018 PQRS Payment Adjustment

    We finalized the following criterion for the satisfactory reporting for individual EPs reporting individual measures via a direct EHR product or an EHR data submission vendor product for the 2017 PQRS payment adjustment (see Table 50 at 79 FR 67796): For the applicable 12-month reporting period, report at least 9 measures covering at least 3 of the NQS domains. If an EP's direct EHR product or EHR data submission vendor product does not contain patient data for at least 9 measures covering at least 3 domains, then the EP must report all of the measures for which there is Medicare patient data. Although all-

    payer data may be included in the file, an EP must report on at least 1 measure for which there is Medicare patient data for their submission to be considered for PQRS.

    To be consistent with the criterion we finalized for the 2017 PQRS payment adjustment, as well as to continue to align with the final criterion for meeting the clinical quality measure (CQM) component of achieving meaningful use under the Medicare EHR Incentive Program, we are proposing to amend Sec. 414.90(j) to specify the criterion for the satisfactory reporting for individual EPs to report individual measures via a direct EHR product or an EHR data submission vendor product for the 2018 PQRS payment adjustment. Specifically, the EP would report at least 9 measures covering at least 3 of the NQS domains. If an EP's direct EHR product or EHR data submission vendor product does not contain patient data for at least 9 measures covering at least 3 domains, then the EP would be required to report all of the measures for which there is Medicare patient data. An EP would be required to report on at least 1 measure for which there is Medicare patient data.

    We seek public comment on this proposal.

    c. Proposed Criterion for Satisfactory Reporting of Measures Groups via Registry for Individual EPs for the 2018 PQRS Payment Adjustment

    We finalized the following criterion for the satisfactory reporting for individual EPs to report measures groups via registry for the 2017 PQRS payment adjustment (see Table 50 at 79 FR 67796): For the applicable 12-month reporting period, report at least 1 measures group AND report each measures group for at least 20 patients, the majority (11 patients) of which must be Medicare Part B FFS patients. Measures groups containing a measure with a 0 percent performance rate will not be counted.

    To be consistent with the criterion we finalized for the 2017 PQRS payment adjustment, we are proposing to amend Sec. 414.90(j) to specify the same criterion for the satisfactory reporting for individual EPs to report measures groups via registry for the 2018 PQRS payment adjustment. Specifically, for the 12-month reporting period for the 2018 PQRS payment adjustment, the EP would report at least 1 measures group AND report each measures group for at

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    least 20 patients, the majority (11 patients) of which would be required to be Medicare Part B FFS patients. Measures groups containing a measure with a 0 percent performance rate would not be counted.

    We seek public comment on our proposed satisfactory reporting criterion for individual EPs reporting measures groups via registry for the 2018 PQRS payment adjustment.

    4. Satisfactory Participation in a QCDR by Individual EPs

    Section 601(b) of the ATRA amended section 1848(m)(3) of the Act, by redesignating subparagraph (D) as subparagraph (F) and adding new subparagraphs (D) and (E), to provide for a new standard for individual EPs to satisfy the PQRS beginning in 2014, based on satisfactory participation in a QCDR.

    a. Proposed Criterion for the Satisfactory Participation for Individual EPs in a QCDR for the 2018 PQRS Payment Adjustment

    Section 1848(a)(8) of the Act provides that for covered professional services furnished by an EP during 2015 or any subsequent year, if the EP does not satisfactorily report data on quality measures for covered professional services for the quality reporting period for the year, the fee schedule amount for services furnished by such professional during the year shall be equal to the applicable percent of the fee schedule amount that would otherwise apply to such services. For 2016 and subsequent years, the applicable percent is 98.0 percent.

    Section 1848(m)(3)(D) of the Act, as added by section 601(b) of the ATRA, authorizes the Secretary to treat an individual EP as satisfactorily submitting data on quality measures under section 1848(m)(3)(A) of the Act if, in lieu of reporting measures under section 1848(k)(2)(C) of the Act, the EP is satisfactorily participating in a QCDR for the year. ``Satisfactory participation'' is a relatively new standard under the PQRS and is an analogous standard to the standard of ``satisfactory reporting'' data on covered professional services that EPs who report through other mechanisms must meet to avoid the PQRS payment adjustment. Currently, Sec. 414.90(e)(2) states that individual EPs must be treated as satisfactorily reporting data on quality measures if the individual EP satisfactorily participates in a QCDR.

    To be consistent with the number of measures reported for the satisfactory participation criterion we finalized for the 2017 PQRS payment adjustment (see Table 50 at 79 FR 67796), for purposes of the 2018 PQRS payment adjustment (which would be based on data reported during the 12-month period that falls in CY 2016), we propose to revise Sec. 414.90(k) to use the same criterion for individual EPs to satisfactorily participate in a QCDR for the 2018 PQRS payment adjustment. Specifically, for the 12-month reporting period for the 2018 PQRS payment adjustment, the EP would report at least 9 measures available for reporting under a QCDR covering at least 3 of the NQS domains, AND report each measure for at least 50 percent of the EP's patients. Of these measures, the EP would report on at least 2 outcome measures, OR, if 2 outcomes measures are not available, report on at least 1 outcome measures and at least 1 of the following types of measures--resource use, patient experience of care, efficiency/

    appropriate use, or patient safety.

    We seek public comment on this proposal.

    5. Proposed Criteria for Satisfactory Reporting for Group Practices Participating in the GPRO

    In lieu of reporting measures under section 1848(k)(2)(C) of the Act, section 1848(m)(3)(C) of the Act provides the Secretary with the authority to establish and have in place a process under which EPs in a group practice (as defined by the Secretary) shall be treated as satisfactorily submitting data on quality measures. Accordingly, this section III.K.4 contains our proposed satisfactory reporting criteria for group practices participating in the GPRO. Please note that, for a group practice to participate in the PQRS GPRO in lieu of participating as individual EPs, a group practice is required to register to participate in the PQRS GPRO. For more information on GPRO participation, please visit http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Group_Practice_Reporting_Option.html. For more information on registration, please visit http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/Self-Nomination-Registration.html.

    a. The CAHPS for PQRS Survey

    In the CY 2015 PFS final rule, we required group practices of 100 or more EPs that register to participate in the GPRO for 2015 reporting to select a CMS-certified survey vendor to report the CAHPS for PQRS survey, regardless of the reporting mechanism the group practice chooses (79 FR 67794). We also stated that group practices would bear the cost of administering the CAHPS for PQRS survey. To collect CAHPS for PQRS data from smaller groups, for purposes of the 2018 PQRS payment adjustment (which would be based on data reported during the 12-month period that falls in CY 2016), we propose to require group practices of 25 or more EPs that register to participate in the GPRO and select the GPRO web interface as the reporting mechanism to select a CMS-certified survey vendor to report CAHPS for PQRS. We believe this proposal is consistent with our effort to collect CAHPS for PQRS data whenever possible. However, we are excluding from this proposal group practices that report measures using the qualified registry, EHR, and QCDR reporting mechanisms, because we have discovered that certain group practices reporting through these mechanisms may be highly specialized or otherwise unable to report CAHPS for PQRS. Please note that we are still proposing to keep CAHPS for PQRS reporting as an option for all group practices. We note that all group practices that would be required to report or voluntarily elect to report CAHPS for PQRS would need to continue to select and pay for a CMS-certified survey vendor to administer the CAHPS for PQRS survey on their behalf. We invite public comment on this proposal.

    We understand that this proposed requirement may cause concern for smaller group practices who choose to participate in the PQRS via the GPRO web interface, particularly those who have not yet administered the CAHPS for PQRS survey (as we introduced reporting of the CAHPS for PQRS survey in 2014) or those group practices who do not believe the CAHPS for PQRS survey applies to their practice. Since the introduction of the CAHPS for PQRS survey, we have received questions as on when the CAHPS for PQRS survey applies to a group practice. In this section below, we seek to clarify questions we have received regarding the administration of the CAHPS for PQRS survey. We note that this proposed requirement would only apply to group practices of 25 or more EPs for whom CAHPS for PQRS applies.

    In addition, we note that we finalized a 12-month reporting period for the administration of the CAHPS for PQRS survey. However, as group practice s have until June of the applicable reporting period (that is, June 30, 2016 for the 12-month reporting period occurring January 1, 2016-December 31, 2016) to elect to participate in the PQRS as a GPRO and administer CAHPS for PQRS, it is not technically feasible for us to collect data for purposes of CAHPS for PQRS until the close of the GPRO

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    registration period. As such, the administration of the CAHPS for PQRS survey only contains 6-months of data. We do not believe this significantly alters the administration of CAHPS for PQRS, as we believe that 6-months of data provides an adequate sample of the 12-

    month reporting period.

    The CAHPS for PQRS survey consists of the core CAHPS Clinician & Group Survey developed by AHRQ, plus additional survey questions to meet CMS' information and program needs. The survey questions are aggregated into 12 content domains called Summary Survey Measures (SSMs). SSMs contain one or more survey questions. The CAHPS for PQRS survey consists of the following survey measures: (1) Getting timely care, appointments, & information; (2) How well your providers communicate; (3) Patient's rating of provider; (4) Access to specialists; (5) Health promotion and education; (6) Shared decision making; (7) Health status & functional status; (8) Courteous & helpful office staff; (9) Care coordination; (10) Between visit communication; (11) Helping you take medications as directed; and (12) Stewardship of patient resources. For the CAHPS for PQRS survey to apply to a group practice, the group practice must have an applicable focal provider as well as meet the minimum beneficiary sample for the CAHPS for PQRS survey.

    Identifying Focal Providers: Which provider does the survey ask about? The provider named in the survey provided the beneficiary with the plurality of the beneficiary's primary care services delivered by the group practice. Plurality of care is based on the number of primary care service visits to a provider. The provider named in the survey can be a physician (primary care provider or specialist), nurse practitioner (NP), physician's assistant (PA), or clinical nurse specialist (CNS).

    Exclusion Criteria for Focal Providers: Several specialty types are excluded from selection as focal provider such as anesthesiology, pathology, psychiatry optometry, diagnostic radiology, chiropractic, podiatry, audiology, physical therapy, occupational therapy, clinical psychology, diet/nutrition, emergency medicine, addiction medicine, critical care, and clinical social work. Hospitalists are also excluded from selection as a focal provider.

    Beneficiary Sample Selection: CMS retrospectively assigns Medicare beneficiaries to your group practice based on whether the group provided a wide range of primary care services. Assigned beneficiaries must have a plurality of their primary care claims delivered by the group practice. Assigned beneficiaries have at least one month of both Part A and Part B enrollment and no months of Part A only enrollment or Part B only enrollment. Assigned beneficiaries cannot have any months of enrollment in a Medicare Advantage plan. Regardless of the number of EPs, some group practices may not have a sufficient number of assigned beneficiaries to participate in the CAHPS for PQRS survey.

    We draw a sample of Medicare beneficiaries assigned to a practice. For practices with 100 or more eligible providers, the desired sample is 860, and the minimum sample is 416. For practices with 25 to 99 eligible providers, the desired sample is 860, and the minimum sample is 255. For practices with 2 to 24 eligible providers, the desired sample is 860, and the minimum sample is 125. The following beneficiaries are excluded in the practice's patient sample: Beneficiaries under age 18 at the time of the sample draw; beneficiaries known to be institutionalized at the time of the sample draw; and beneficiaries with no eligible focal provider. For more information on CAHPS for PQRS, please visit the PQRS Web site at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/CMS-Certified-Survey-Vendor.html.

    b. Proposed Criteria for Satisfactory Reporting on PQRS Quality Measures via the GPRO Web Interface for the 2018 PQRS Payment Adjustment

    Under our authority specified for the group practice reporting requirements under section 1848(m)(3)(C) of the Act--to be consistent with the criterion we finalized for the satisfactory reporting of PQRS quality measures for group practices registered to participate in the GPRO for the 2017 PQRS payment adjustment using the GPRO web interface (see Table 51 at 79 FR 67797)--we propose to amend Sec. 414.90(j) to specify criteria for the satisfactory reporting of PQRS quality measures for group practices registered to participate in the GPRO for the 12-month reporting period for the 2018 PQRS payment adjustment using the GPRO web interface for groups practices of 25 or more EPs for which the CAHPS for PQRS survey does not apply. Specifically, the group practice would report on all measures included in the web interface; AND populate data fields for the first 248 consecutively ranked and assigned beneficiaries in the order in which they appear in the group's sample for each module or preventive care measure. If the pool of eligible assigned beneficiaries is less than 248, then the group practice would report on 100 percent of assigned beneficiaries. In other words, we understand that, in some instances, the sampling methodology CMS provides will not be able to assign at least 248 patients on which a group practice may report, particularly those group practices on the smaller end of the range of 25-99 EPs. If the group practice is assigned less than 248 Medicare beneficiaries, then the group practice would report on 100 percent of its assigned beneficiaries. A group practice would be required to report on at least 1 measure in the GPRO web interface. Although the criteria proposed above are specified for groups practices of 25 or more EPs, please note that, given our proposal below to require that group practices of 25 or more EPs report the CAHPS for PQRS survey, the criteria proposed above would apply to a group practices of 25 or more EPs only if the CAHPS for PQRS survey does not apply to the group practice.

    Furthermore, similar to the criteria we established for the 2017 PQRS payment adjustment (see Table 51 at 79 FR 67797), as we specified in section III.K.4.a., we propose to require that group practices of 25 or more EPs who elect to report quality measures via the GPRO web interface report the CAHPS for PQRS survey, if applicable. Therefore, similar to the criteria we established for the 2017 PQRS payment adjustment in accordance with section 1848(m)(3)(C) of the Act (see Table 51 at 79 FR 67797), we propose to amend Sec. 414.90(j) to specify criteria for the satisfactory reporting of PQRS quality measures for group practices of 25 or more EPs that registered to participate in the GPRO for the 12-month reporting period for the 2018 PQRS payment adjustment using the GPRO web interface and for which the CAHPS for PQRS survey applies. Specifically, if a group practice chooses to use the GPRO web interface in conjunction with reporting the CAHPS for PQRS survey measures, we propose to specify the criterion for satisfactory reporting for the 2018 PQRS payment adjustment. For the 12-month reporting period for the 2018 PQRS payment adjustment, the group practice would report all CAHPS for PQRS survey measures via a certified survey vendor. In addition, the group practice would report on all measures included in the GPRO web interface; AND populate data fields for the first 248 consecutively ranked and assigned beneficiaries in the order in which they appear in the group's sample for each

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    module or preventive care measure. If the pool of eligible assigned beneficiaries is less than 248, then the group practice would report on 100 percent of assigned beneficiaries. A group practice would be required to report on at least 1 measure for which there is Medicare patient data.

    For assignment of patients for group practices reporting via the GPRO web interface, in previous years, we have aligned with the Medicare Shared Savings Program methodology of beneficiary assignment (see 77 FR 69195). However, for the 2017 PQRS payment adjustment, we used a beneficiary attribution methodology utilized within the VM for the claims-based quality measures and cost measures that is slightly different from the Medicare Shared Savings Program assignment methodology that applied in 2015, namely (1) eliminating the primary care service pre-step that is statutorily required for the Shared Savings Program and (2) including NPs, PAs, and CNSs in step 1 rather than in step 2 of the attribution process. We believe that aligning with the VM's method of attribution is appropriate, as the VM is directly tied to participation in the PQRS (79 FR 67790). Therefore, to be consistent with the sampling methodology we used for the 2017 PQRS payment adjustment, we propose to continue using the attribution methodology used for the VM for the GPRO web interface beneficiary assignment methodology for the 2018 PQRS payment adjustment and future years.

    As we clarified in the CY 2015 PFS final rule with comment period (79 FR 67790), if a group practice has no Medicare patients for which any of the GPRO measures are applicable, the group practice will not meet the criteria for satisfactory reporting using the GPRO web interface. Therefore, to meet the criteria for satisfactory reporting using the GPRO web interface, a group practice must be assigned and have sampled at least 1 Medicare patient for any of the applicable GPRO web interface measures. If a group practice does not typically see Medicare patients for which the GPRO web interface measures are applicable, or if the group practice does not have adequate billing history for Medicare patients to be used for assignment and sampling of Medicare patients into the GPRO web interface, we advise the group practice to participate in the PQRS via another reporting mechanism.

    We invite public comment on these proposals.

    c. Proposed Criteria for Satisfactory Reporting on Individual PQRS Quality Measures for Group Practices Registered To Participate in the GPRO via Registry for the 2018 PQRS Payment Adjustment

    We finalized the following satisfactory reporting criteria for the submission of individual quality measures via registry for group practices of 2-99 EPs in the GPRO for the 2017 PQRS payment adjustment (see Table 51 at 79 FR 67797): Report at least 9 measures, covering at least 3 of the NQS domains, OR, if less than 9 measures covering at least 3 NQS domains apply to the group practice, report up to 8 measures covering 1-3 NQS domains for which there is Medicare patient data, AND report each measure for at least 50 percent of the group practice's Medicare Part B FFS patients seen during the reporting period to which the measure applies.

    Consistent with the group practice reporting criteria we finalized for the 2017 PQRS payment adjustment in accordance with section 1848(m)(3)(C) of the Act, for those group practices that choose to report using a qualified registry, we propose to amend Sec. 414.90(j) to specify satisfactory reporting criteria via qualified registry for group practices of 2 EPs who select to participate in the GPRO for the 2018 PQRS payment adjustment. Specifically, for the 12-month 2018 PQRS payment adjustment reporting period, the group practice would report at least 9 measures, covering at least 3 of the NQS domains. Of these measures, if a group practice has an EP that sees at least 1 Medicare patient in a face-to-face encounter, the group practice would report on at least 1 measure in the PQRS cross-cutting measure set. If the group practice reports on less than 9 measures covering at least 3 NQS domains, the group practice would report on each measure that is applicable to the group practice, AND report each measure for at least 50 percent of the EP's Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measures with a 0 percent performance rate would not be counted.

    In addition, if a group practice of 2 EPs chooses instead to use a qualified registry in conjunction with reporting the CAHPS for PQRS survey measures, for the 12-month reporting period for the 2018 PQRS payment adjustment, the group practice would report all CAHPS for PQRS survey measures via a certified survey vendor, and report at least 6 additional measures, outside of the CAHPS for PQRS survey, covering at least 2 of the NQS domains using the qualified registry. If less than 6 measures apply to the group practice, the group practice must report on each measure that is applicable to the group practice. Of the non-CAHPS for PQRS measures, if any EP in the group practice sees at least 1 Medicare patient in a face-to-face encounter, the group practice would be required to report on at least 1 measure in the PQRS cross-cutting measure set. We note that this proposed option to report 6 additional measures, including at least 1 cross-cutting measure if a group practice sees at least 1 Medicare patient in a face-to-face encounter, is consistent with the proposed criterion for satisfactory reporting for the 2018 PQRS payment adjustment via qualified registry.

    As with individual reporting, we understand that there may be instances where a group practice may not have at least 9 measures applicable to a group practice's practice. In this instance, like the criterion we finalized for the 2017 PQRS payment adjustment (see Table 51 at 79 FR 67797), a group practice reporting on less than 9 measures would still be able to meet the satisfactory reporting criterion via registry if the group practice reports on each measure that is applicable to the group practice's practice. If a group practice reports on less than 9 measures, the group practice would be subject to the MAV process, which would allow us to determine whether a group practice should have reported quality data codes for additional measures and/or measures covering additional NQS domains. In addition, if a group practice does not report on at least 1 cross-cutting measure and the group practice has at least 1 EP who sees at least 1 Medicare patient in a face-to-face encounter, the MAV will also allow us to determine whether a group practice should have reported on any of the PQRS cross-cutting measures. The MAV process we are proposing to implement for registry reporting is a similar process that was established for reporting periods occurring in 2015 for the 2017 PQRS payment adjustment. However, please note that the MAV process for the 2018 PQRS payment adjustment will now allow us to determine whether a group practice should have reported on at least 1 cross-cutting measure. For more information on the registry MAV process, please visit http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2014_PQRS_Registry_MeasureApplicabilityValidation_12132013.zip.

    We invite public comment on these proposals.

    Page 41824

    d. Proposed Criteria for Satisfactory Reporting on Individual PQRS Quality Measures for Group Practices Registered To Participate in the GPRO via EHR for the 2018 PQRS Payment Adjustment

    For EHR reporting, consistent with the criterion finalized for the 2017 PQRS payment adjustment (see Table 51 at 79 FR 67797) that aligns with the criteria established for meeting the CQM component of meaningful use under the Medicare EHR Incentive Program and in accordance with the group practice reporting requirements under section 1848(m)(3)(C) of the Act, for those group practices that choose to report using an EHR, we propose to amend Sec. 414.90(j) to specify satisfactory reporting criteria via a direct EHR product or an EHR data submission vendor product for group practices of 2 EPs who select to participate in the GPRO for the 2018 PQRS payment adjustment. Specifically, for the 12-month reporting period for the 2018 PQRS payment adjustment, the group practice would report 9 measures covering at least 3 domains. If the group practice's direct EHR product or EHR data submission vendor product does not contain patient data for at least 9 measures covering at least 3 domains, then the group practice must report all of the measures for which there is Medicare patient data. A group practice must report on at least 1 measure for which there is Medicare patient data.

    In addition, if a group practice of 2 EPs chooses instead to use a direct EHR product or EHR data submission vendor in conjunction with reporting the CAHPS for PQRS survey measures, for the 12-month reporting period for the 2018 PQRS payment adjustment, the group practice would report all CAHPS for PQRS survey measures via a certified survey vendor, and report at least 6 additional measures, outside of the CAHPS for PQRS survey, covering at least 2 of the NQS domains using the direct EHR product or EHR data submission vendor product. If less than 6 measures apply to the group practice, the group practice must report all applicable measures. Of the non-CAHPS for PQRS measures that must be reported in conjunction with reporting the CAHPS for PQRS survey measures, a group practice would be required to report on at least 1 measure for which there is Medicare patient data. We note that this proposed option to report 6 additional measures is consistent with the proposed criterion for satisfactory reporting for the 2018 PQRS payment adjustment via EHR without CAHPS for PQRS, since both criteria assess a total of 3 domains.

    We invite public comment on these proposals.

    e. Satisfactory Participation in a QCDR for Group Practices Registered To Participate in the GPRO via a QCDR for the 2018 PQRS Payment Adjustment

    Section 101(d)(1)(B) of the MACRA amends section 1848(m)(3)(D) of the Act by inserting ``and, for 2016 and subsequent years, subparagraph (A) or (C)'' after ``subparagraph (A)''. This change authorizes CMS to create an option for EPs participating in the GPRO to report quality measures via a QCDR.

    As such, please note that we are modifying Sec. 414.90(k) to indicate that group practices may also use a QCDR to participate in the PQRS.

    f. Proposed Reporting Period for the Satisfactory Participation by Individual EPs in a QCDR for the 2018 PQRS Payment Adjustment

    Section 1848(m)(3)(D) of the Act, as redesignated and added by section 601(b) of the America Taxpayer Relief Act of 2012 and further amended by MACRA, authorizes the Secretary to treat a group practice as satisfactorily submitting data on quality measures under section 1848(m)(3)(A) of the Act if the group practice is satisfactorily participating in a QCDR for the year. Given that satisfactory participation is with regard to the year, and to provide consistency with the reporting period applicable to individual EPs who participate in the PQRS via a QCDR, we propose to revise Sec. 414.90(k) to specify a 12-month, CY reporting period from January 1, 2016 through December 31, 2016 for group practices participating in the GPRO to satisfactorily participate in a QCDR for purposes of the 2018 PQRS payment adjustment. We are proposing a 12-month reporting period. Based on our experience with the 12 and 6-month reporting periods for the PQRS incentives, we believe that data on quality measures collected based on 12-months provides a more accurate assessment of actions performed in a clinical setting than data collected based on shorter reporting periods. In addition, we believe a 12-month reporting period is appropriate given that the full calendar year would be utilized with regard to the participation by the group practice in the QCDR. We invite public comment on the proposed 12-month, CY 2016 reporting period for the satisfactory participation of group practices in a QCDR for the 2018 PQRS payment adjustment.

    g. Proposed Criteria for Satisfactory Participation in a QCDR for Group Practices Registered To Participate in the GPRO via a QCDR for the 2018 PQRS Payment Adjustment

    To be consistent with individual reporting criteria that we finalized for the 2017 PQRS payment adjustment (see Table 50 at 79 FR 67796) as well as our proposed individual reporting criteria for the 2018 PQRS payment adjustment, for purposes of the 2018 PQRS payment adjustment (which would be based on data reported during the 12-month period that falls in CY 2016), we propose to amend Sec. 414.90(j) to use the same criterion for group practices as individual EPs to satisfactorily participate in a QCDR for the 2018 PQRS payment adjustment. Specifically, for the 12-month reporting period for the 2018 PQRS payment adjustment, the group practice would report at least 9 measures available for reporting under a QCDR covering at least 3 of the NQS domains, AND report each measure for at least 50 percent of the group practice's patients. Of these measures, the group practice would report on at least 2 outcome measures, OR, if 2 outcomes measures are not available, report on at least 1 outcome measures and at least 1 of the following types of measures--resource use, patient experience of care, efficiency/appropriate use, or patient safety.

    Tables 20 and 21 reflect our proposed criteria for satisfactory reporting--or, in lieu of satisfactory reporting, satisfactory participation in a QCDR--for the 2018 PQRS payment adjustment:

    Page 41825

    Table 20--Summary of Proposed Requirements for the 2018 PQRS Payment Adjustment: Individual Reporting Criteria

    for the Satisfactory Reporting of Quality Measures Data via Claims, Qualified Registry, and EHRS and

    Satisfactory Participation Criterion in QCDRS

    ----------------------------------------------------------------------------------------------------------------

    Reporting Satisfactory reporting/satisfactory

    Reporting period Measure type mechanism participation criteria

    ----------------------------------------------------------------------------------------------------------------

    12-month (Jan 1-Dec 31, 2016). Individual Claims........... Report at least 9 measures, covering at

    Measures. least 3 of the NQS domains AND report

    each measure for at least 50 percent of

    the EP's Medicare Part B FFS patients

    seen during the reporting period to which

    the measure applies. Of the measures

    reported, if the EP sees at least 1

    Medicare patient in a face-to-face

    encounter, the EP will report on at least

    1 measure contained in the PQRS cross-

    cutting measure set. If less than 9

    measures apply to the EP, the EP would

    report on each measure that is

    applicable), AND report each measure for

    at least 50 percent of the Medicare Part

    B FFS patients seen during the reporting

    period to which the measure applies.

    Measures with a 0 percent performance

    rate would not be counted.

    12-month (Jan 1-Dec 31, 2016). Individual Qualified Report at least 9 measures, covering at

    Measures. Registry. least 3 of the NQS domains AND report

    each measure for at least 50 percent of

    the EP's Medicare Part B FFS patients

    seen during the reporting period to which

    the measure applies. Of the measures

    reported, if the EP sees at least 1

    Medicare patient in a face-to-face

    encounter, the EP will report on at least

    1 measure contained in the PQRS cross-

    cutting measure set. If less than 9

    measures apply to the EP, the EP would

    report on each measure that is

    applicable, AND report each measure for

    at least 50 percent of the Medicare Part

    B FFS patients seen during the reporting

    period to which the measure applies.

    Measures with a 0 percent performance

    rate would not be counted.

    12-month (Jan 1-Dec 31, 2016). Individual Direct EHR Report 9 measures covering at least 3 of

    Measures. Product or EHR the NQS domains. If an EP's direct EHR

    Data Submission product or EHR data submission vendor

    Vendor Product. product does not contain patient data for

    at least 9 measures covering at least 3

    domains, then the EP would be required to

    report all of the measures for which

    there is Medicare patient data. An EP

    would be required to report on at least 1

    measure for which there is Medicare

    patient data.

    12-month (Jan 1-Dec 31, 2016). Measures Groups.. Qualified Report at least 1 measures group AND

    Registry. report each measures group for at least

    20 patients, the majority (11 patients)

    of which are required to be Medicare Part

    B FFS patients. Measures groups

    containing a measure with a 0 percent

    performance rate will not be counted.

    12-month (Jan 1-Dec 31, 2016). Individual PQRS Qualified Report at least 9 measures available for

    measures and/or Clinical Data reporting under a QCDR covering at least

    non-PQRS Registry (QCDR). 3 of the NQS domains, AND report each

    measures measure for at least 50 percent of the

    reportable via a EP's patients. Of these measures, the EP

    QCDR. would report on at least 2 outcome

    measures, OR, if 2 outcomes measures are

    not available, report on at least 1

    outcome measures and at least 1 of the

    following types of measures--resource

    use, patient experience of care,

    efficiency/appropriate use, or patient

    safety.

    ----------------------------------------------------------------------------------------------------------------

    Table 21--Summary of Proposed Requirements for the 2018 PQRS Payment Adjustment: Group Practice Reporting

    Criteria for Satisfactory Reporting of Quality Measures Data via the GPRO

    ----------------------------------------------------------------------------------------------------------------

    Group practice Reporting Satisfactory reporting

    Reporting period size Measure type mechanism criteria

    ----------------------------------------------------------------------------------------------------------------

    12-month (Jan 1-Dec 31, 2016) 25 EPs (if Individual GPRO GPRO Web Report on all measures

    CAHPS for PQRS Measures in Interface. included in the web

    does not the GPRO Web interface; AND populate data

    apply). Interface. fields for the first 248

    consecutively ranked and

    assigned beneficiaries in the

    order in which they appear in

    the group's sample for each

    module or preventive care

    measure. If the pool of

    eligible assigned

    beneficiaries is less than

    248, then the group practice

    must report on 100 percent of

    assigned beneficiaries. In

    other words, we understand

    that, in some instances, the

    sampling methodology we

    provide will not be able to

    assign at least 248 patients

    on which a group practice may

    report, particularly those

    group practices on the

    smaller end of the range of

    25-99 EPs. If the group

    practice is assigned less

    than 248 Medicare

    beneficiaries, then the group

    practice must report on 100

    percent of its assigned

    beneficiaries. A group

    practice must report on at

    least 1 measure for which

    there is Medicare patient

    data.

    Page 41826

    12-month (Jan 1-Dec 31, 2016) 25 EPs (if Individual GPRO GPRO Web The group practice must have

    CAHPS for PQRS Measures in Interface all CAHPS for PQRS survey

    applies). the GPRO Web CMS-Certified measures reported on its

    Interface Survey Vendor. behalf via a CMS-certified

    CAHPS for PQRS. survey vendor. In addition,

    the group practice must

    report on all measures

    included in the GPRO web

    interface; AND populate data

    fields for the first 248

    consecutively ranked and

    assigned beneficiaries in the

    order in which they appear in

    the group's sample for each

    module or preventive care

    measure. If the pool of

    eligible assigned

    beneficiaries is less than

    248, then the group practice

    must report on 100 percent of

    assigned beneficiaries. A

    group practice will be

    required to report on at

    least 1 measure for which

    there is Medicare patient

    data.

    Please note that, if the CAHPS

    for PQRS survey is applicable

    to a group practice who

    reports quality measures via

    the GPRO web interface, the

    group practice must

    administer the CAHPS for PQRS

    survey in addition to

    reporting the GPRO web

    interface measures.

    12-month (Jan 1-Dec 31, 2016) 2 EPs......... Individual Qualified Report at least 9 measures,

    Measures. Registry. covering at least 3 of the

    NQS domains. Of these

    measures, if a group practice

    sees at least 1 Medicare

    patient in a face-to-face

    encounter, the group practice

    would report on at least 1

    measure in the PQRS cross-

    cutting measure set. If less

    than 9 measures covering at

    least 3 NQS domains apply to

    the group practice, the group

    practice would report on each

    measure that is applicable to

    the group practice, AND

    report each measure for at

    least 50 percent of the

    group's Medicare Part B FFS

    patients seen during the

    reporting period to which the

    measure applies. Measures

    with a 0 percent performance

    rate would not be counted.

    12-month (Jan 1-Dec 31, 2016) 2 EPs that Individual Qualified The group practice must have

    elect CAHPS Measures Registry CMS- all CAHPS for PQRS survey

    for PQRS. CAHPS for PQRS. Certified measures reported on its

    Survey Vendor. behalf via a CMS-certified

    survey vendor, and report at

    least 6 additional measures,

    outside of the CAHPS for PQRS

    survey, covering at least 2

    of the NQS domains using the

    qualified registry. If less

    than 6 measures apply to the

    group practice, the group

    practice must report on each

    measure that is applicable to

    the group practice. Of the

    additional measures that must

    be reported in conjunction

    with reporting the CAHPS for

    PQRS survey measures, if any

    EP in the group practice sees

    at least 1 Medicare patient

    in a face-to-face encounter,

    the group practice must

    report on at least 1 measure

    in the PQRS cross-cutting

    measure set.

    12-month (Jan 1-Dec 31, 2016) 2 EPs......... Individual Direct EHR Report 9 measures covering at

    Measures. Product or EHR least 3 domains. If the group

    Data practice's direct EHR product

    Submission or EHR data submission vendor

    Vendor Product. product does not contain

    patient data for at least 9

    measures covering at least 3

    domains, then the group

    practice must report all of

    the measures for which there

    is Medicare patient data. A

    group practice must report on

    at least 1 measure for which

    there is Medicare patient

    data.

    12-month (Jan 1-Dec 31, 2016) 2 EPs that Individual Direct EHR The group practice must have

    elect CAHPS Measures Product or EHR all CAHPS for PQRS survey

    for PQRS. CAHPS for PQRS. Data measures reported on its

    Submission behalf via a CMS-certified

    Vendor Product survey vendor, and report at

    CMS- least 6 additional measures,

    Certified outside of CAHPS for PQRS,

    Survey Vendor. covering at least 2 of the

    NQS domains using the direct

    EHR product or EHR data

    submission vendor product. If

    less than 6 measures apply to

    the group practice, the group

    practice must report all of

    the measures for which there

    is Medicare patient data. Of

    the additional 6 measures

    that must be reported in

    conjunction with reporting

    the CAHPS for PQRS survey

    measures, a group practice

    would be required to report

    on at least 1 measure for

    which there is Medicare

    patient data.

    Page 41827

    12-month (Jan 1-Dec 31, 2016) 2 EPs......... Individual PQRS Qualified Report at least 9 measures

    measures and/ Clinical Data available for reporting under

    or non-PQRS Registry a QCDR covering at least 3 of

    measures (QCDR). the NQS domains, AND report

    reportable via each measure for at least 50

    a QCDR. percent of the group

    practice's patients. Of these

    measures, the group practice

    would report on at least 2

    outcome measures, OR, if 2

    outcomes measures are not

    available, report on at least

    1 outcome measures and at

    least 1 of the following

    types of measures--resource

    use, patient experience of

    care, efficiency/appropriate

    use, or patient safety.

    ----------------------------------------------------------------------------------------------------------------

    6. Statutory Requirements and Other Considerations for the Selection of PQRS Quality Measures for Meeting the Criteria for Satisfactory Reporting for 2016 and Beyond for Individual EPs and Group Practices

    Annually, we solicit or ``Call for Measures'' from the public for possible inclusion in the PQRS. During the Call for Measures, we request measures for inclusion in PQRS that meet the following statutory and other criteria.

    Sections 1848(k)(2)(C) and 1848(m)(3)(C)(i) of the Act, respectively, govern the quality measures reported by individual EPs and group practices under the PQRS. Under section 1848(k)(2)(C)(i) of the Act, the PQRS quality 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 section 1890(a) of the Act, which is currently the National Quality Forum (NQF). However, 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 NQF, section 1848(k)(2)(C)(ii) of the Act authorizes the Secretary to 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. In light of these statutory requirements, we believe that, except in the circumstances specified in the statute, each PQRS quality measure must be endorsed by the NQF. Additionally, section 1848(k)(2)(D) of the Act requires that for each PQRS quality measure, the Secretary shall ensure that EPs have the opportunity to provide input during the development, endorsement, or selection of measures applicable to services they furnish. The statutory requirements under section 1848(k)(2)(C) of the Act, subject to the exception noted previously, require only that the measures be selected from measures that have been endorsed by the entity with a contract with the Secretary under section 1890(a) of the Act (that is, the NQF) and are silent as to how the measures that are submitted to the NQF for endorsement are developed.

    The steps for developing measures applicable to physicians and other EPs prior to submission of the measures for endorsement may be carried out by a variety of different organizations. We do not believe there needs to be special restrictions on the type or make-up of the organizations carrying out this process of development of physician measures, such as restricting the initial development to physician-

    controlled organizations. Any such restriction would unduly limit the development of quality measures and the scope and utility of measures that may be considered for endorsement as voluntary consensus standards for purposes of the PQRS.

    In addition to section 1848(k)(2)(C) of the Act, section 1890A of the Act, which was added by section 3014(b) of the Affordable Care Act, requires that the Secretary establish a pre-rulemaking process under which certain steps occur for the selection of certain categories of quality and efficiency measures, one of which is that the entity with a contract with the Secretary under section 1890(a) of the Act (that is, the NQF) convene multi-stakeholder groups to provide input to the Secretary on the selection of such measures. These categories are described in section 1890(b)(7)(B) of the Act, and include such measures as the quality measures selected for reporting under the PQRS. In accordance with section 1890A(a)(1) of the Act, the NQF convened multi-stakeholder groups by creating the MAP. Section 1890A(a)(2) of the Act requires that the Secretary must make publicly available by December 1st of each year a list of the quality and efficiency measures that the Secretary is considering for selection through rulemaking for use in the Medicare program. The NQF must provide CMS with the MAP's input on the selection of measures by February 1st of each year. The lists of measures under consideration for selection through rulemaking in 2015 are available at http://www.qualityforum.org/map/.

    As we noted above, section 1848(k)(2)(C)(ii) of the Act provides an exception to the requirement that the Secretary select measures that have been endorsed by the entity with a contract under section 1890(a) of the Act (that is, the NQF). We may select measures under this exception if there is a specified area or medical topic for which a feasible and practical measure has not been endorsed by the entity, as long as due consideration is given to measures that have been endorsed or adopted by a consensus organization identified by the Secretary. Under this exception, aside from NQF endorsement, we requested that stakeholders apply the following considerations when submitting measures for possible inclusion in the PQRS measure set:

    Measures that are not duplicative of another existing or proposed measure.

    Measures that are further along in development than a measure concept.

    We are not accepting claims-based-only reporting measures in this process.

    Measures that are outcome-based rather than clinical process measures.

    Measures that address patient safety and adverse events.

    Measures that identify appropriate use of diagnosis and therapeutics.

    Measures that include the NQS domain for care coordination and communication.

    Measures that include the NQS domain for patient experience and patient-reported outcomes.

    Measures that address efficiency, cost and resource use.

    Page 41828

    a. Proposed PQRS Quality Measures

    Taking into consideration the statutory and non-statutory criteria we described previously, this section contains our proposals for the inclusion or removal of measures in PQRS for 2016 and beyond. We are classifying all proposed measures against six domains based on the NQS's six priorities, as follows:

    (1) Patient Safety. These are measures that reflect the safe delivery of clinical services in all healthcare settings. These measures may address a structure or process that is designed to reduce risk in the delivery of healthcare or measure the occurrence of an untoward outcome such as adverse events and complications of procedures or other interventions.

    (2) Person and Caregiver-Centered Experience and Outcomes. These are measures that reflect the potential to improve patient-centered care and the quality of care delivered to patients. They emphasize the importance of collecting patient-reported data and the ability to impact care at the individual patient level, as well as the population level. These are measures of organizational structures or processes that foster both the inclusion of persons and family members as active members of the health care team and collaborative partnerships with providers and provider organizations or can be measures of patient-

    reported experiences and outcomes that reflect greater involvement of patients and families in decision making, self-care, activation, and understanding of their health condition and its effective management.

    (3) Communication and Care Coordination. These are measures that demonstrate appropriate and timely sharing of information and coordination of clinical and preventive services among health professionals in the care team and with patients, caregivers, and families to improve appropriate and timely patient and care team communication. They may also be measures that reflect outcomes of successful coordination of care.

    (4) Effective Clinical Care. These are measures that reflect clinical care processes closely linked to outcomes based on evidence and practice guidelines or measures of patient-centered outcomes of disease states.

    (5) Community/Population Health. These are measures that reflect the use of clinical and preventive services and achieve improvements in the health of the population served. They may be measures of processes focused on primary prevention of disease or general screening for early detection of disease unrelated to a current or prior condition.

    (6) Efficiency and Cost Reduction. These are measures that reflect efforts to lower costs and to significantly improve outcomes and reduce errors. These are measures of cost, resource use and appropriate use of healthcare resources or inefficiencies in healthcare delivery.

    Please note that the PQRS quality measure specifications for any given proposed PQRS individual quality measure may differ from specifications for the same quality measure used in prior years. For example, for the proposed PQRS quality measures that were selected for reporting in 2016 and beyond, please note that detailed measure specifications, including the measure's title, for the proposed individual PQRS quality measures for 2016 and beyond may have been updated or modified during the NQF endorsement process or for other reasons.

    In addition, due to our desire to align measure titles with the measure titles that have been finalized for 2013, 2014, 2015 reporting, and potentially subsequent years of the Medicare EHR Incentive Program, we note that the measure titles for measures available for reporting via EHR-based reporting mechanisms may change. To the extent that the Medicare EHR Incentive Program updates its measure titles to include version numbers (see 77 FR 13744), we will use these version numbers to describe the PQRS EHR measures that will also be available for reporting for the EHR Incentive Program. We will continue to work toward complete alignment of measure specifications across programs whenever possible.

    Through NQF's measure maintenance process, NQF-endorsed measures are sometimes updated to incorporate changes that we believe do not substantively change the nature of the measure. Examples of such changes may include updated diagnosis or procedure codes or changes to exclusions to the patient population or definitions. While we address such changes on a case-by-case basis, we generally believe these types of maintenance changes are distinct from substantive changes to measures that result in what are considered new or different measures. Further, we believe that non-substantive maintenance changes of this type do not trigger the same agency obligations under the Administrative Procedure Act.

    In the CY 2013 PFS final rule with comment period, we finalized our proposal providing that if the NQF updates an endorsed measure that we have adopted for the PQRS in a manner that we consider to not substantively change the nature of the measure, we would use a subregulatory process to incorporate those updates to the measure specifications that apply to the program (77 FR 69207). We believe this adequately balances our need to incorporate non-substantive NQF updates to NQF-endorsed measures in the most expeditious manner possible, while preserving the public's ability to comment on updates that change an endorsed measure such that it is no longer the same measure that we originally adopted. We also note that the NQF process incorporates an opportunity for public comment and engagement in the measure maintenance process. We will revise the Specifications Manual and post notices to clearly identify the updates and provide links to where additional information on the updates can be found. Updates will also be available on the CMS PQRS Web site at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/index.html.

    We are not the measure steward for most of the measures available for reporting under the PQRS. We rely on outside measure stewards and developers to maintain these measures. In Table 25, we are proposing that certain measures be removed from the PQRS measure set due to the measure steward indicating that it will not be able to maintain the measure. We note that this proposal is contingent upon the measure steward not being able to maintain the measure. Should we learn that a certain measure steward is able to maintain the measure, or that another entity is able to maintain the measure in a manner that allows the measure to be available for reporting under the PQRS for the CY 2018 PQRS payment adjustment, we propose to keep the measure available for reporting under the PQRS and therefore not finalize our proposal to remove the measure. In addition, if, after the display of this proposed rule and before the display of the CY 2016 PFS final rule, we discover additional measures within the current PQRS measure set that a measure steward can no longer maintain, we propose to remove these measures from reporting for the PQRS beginning in 2016. We will discuss any such instances in the CY 2016 PFS final rule with comment period.

    In addition, we note that we have received feedback from stakeholders, particularly first-time participants who find it difficult to understand which measures are applicable to their

    Page 41829

    particular practice. In an effort to aide EPs and group practices to determine what measures best fit their practice, and in collaboration with specialty societies, we are beginning to group our final measures available for reporting according to specialty. The current listing of our measures by specialty can be found on our Web site at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/index.html. Please note that these groups of measures are meant to provide guidance to those EPs seeking to determine what measures to report. EPs are not required to report measures according to these suggested groups of measures. As measures are adopted or revised, we will continue to update these groups to reflect the measures available under the PQRS, as well as add more specialties.

    In Tables 22 through 30, we propose changes to the PQRS measures set. The current PQRS measures list is available at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/PQRS_2015_Measure-List_111014.zip.

    b. Proposed Cross-Cutting Measures for 2016 Reporting and Beyond

    In the CY 2015 PFS final rule with comment period, we finalized a set of 19 cross-cutting measures for reporting in the PQRS for 2015 and beyond (see Table 52 at 79 FR 67801). The current PQRS cross-cutting measure set is available at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2015_PQRS_CrosscuttingMeasures_12172014.pdf. In Table 22, we propose the following measures to be added to the current PQRS cross-cutting measure set. Please note that our rationale for proposing each of these measures is found below the measure description.

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    c. Proposed New PQRS Measures Available for Reporting for 2016 and Beyond and Proposed Changes to Existing PQRS Measures

    Table 23 contains additional measures we propose to include in the PQRS measure set for CY 2016 and beyond. We have also indicated the PQRS reporting mechanism or mechanisms through which each measure could be submitted, as well as the MAP recommendations. Additional comments and measure information from the MAP review can be found at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=78711.

    Please note that, in some cases specified below, we propose adding a measure to the PQRS measure set that the MAP believes requires further development prior to inclusion or does not support a measure for inclusion in the PQRS measure set. Please note that, while CMS takes these recommendations into consideration, in these instances, CMS believes the rationale provided for proposing the addition of a measure outweighs the MAP's recommendation.

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    In Table 24, we provide our proposals for a NQS domain change for measures that are currently available for reporting under the PQRS.

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    In Table 25, we propose to remove the following measures from reporting under the PQRS.

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    In Table 26, we propose to change the mechanism(s) by which an EP or group practice may report a respective PQRS measure beginning in 2016.

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    d. PQRS Measures Groups

    Section 414.90(b) defines a measures group as a subset of six or more PQRS 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.

    We propose to add the following 3 new measures groups as shown in Tables 27, 28 and 29 that will be available for reporting in the PQRS beginning in 2016. Please note that, in these tables, we provide the PQRS measure numbers for the measures within these proposed measures groups that were previously finalized in the PQRS. New measures within these proposed measures groups that are proposed to be added, as indicated in Table 23 above, do not have a PQRS number. Therefore, in lieu of a PQRS number, an ``NA'' is indicated.

    Multiple Chronic Conditions Measures Group: We propose to add the Multiple Chronic Conditions Measures Group in the CY 2016 proposed rule. A large proportion of the Medicare population are impacted by Multiple Chronic Conditions, and providers that treat this population are often not recognized for the complexity of treatment for a patient with multiple chronic conditions. The addition of this measures group would specifically identify those providers that address the exponential complexity of treating the combination of these conditions rather than a sum of the individual conditions. This measures group addresses the

    Page 41873

    complexity of care that is required for patients that may have multiple disease processes that require clinical management and treatment.

    Cardiovascular Prevention Measures Group (Millions Hearts): We propose to add the Cardiovascular Prevention Measures Group in the CY 2016 proposed rule. Prior to 2015, the PQRS included a Cardiovascular Prevention Measures Group (Measures 2, 204, 226, 236, 241 and 317 in 2014 (78 FR 74741)). The measures group was removed for 2015 PQRS reporting due to clinical guideline changes that affected many of the measures. Given the efficacy of cardiovascular prevention on cardiovascular health, this measures group is being re-considered with an adjustment to align with current clinical guidelines. This measures group is also fully supported by the Million Hearts Initiative.

    Diabetic Retinopathy Measures Group: We propose to add the Diabetic Retinopathy Measures Group in the CY 2016 proposed rule. An increase in the frequency of Type 2 diabetes in the pediatric age group is associated with increased childhood obesity. The implications are significantly increased burdens of disability and complications associated with diabetes, including diabetic retinopathy, which has a projected prevalence of 6 million individuals with diabetic retinopathy by the year 2020 in the United States, and a prevalence rate of 28.5% in all adults with diabetes aged 40 and older. The addition of the Diabetic Retinopathy Measures Group would help to address this significant public health problem by allowing for the comprehensive evaluation of provider performance and patient outcomes related to a disease that threatens the eyesight of a very large population, and by supporting improvements in quality of care and outcomes related to diabetic retinopathy.

    Table 27--Cardiovascular Prevention Measures Group for 2016 and Beyond

    Millions Hearts

    ----------------------------------------------------------------------------------------------------------------

    NQF/PQRS Measure title and description Measure developer

    ----------------------------------------------------------------------------------------------------------------

    0419/130........................... Documentation of Current Medications in the Centers for Medicare &

    Medical Record: Percentage of visits for Medicaid Services/Quality

    patients aged 18 years and older for which the Insights of Pennsylvania.

    EP attests to documenting a list of current

    medications using all immediate resources

    available on the date of the encounter. This

    list must include ALL known prescriptions,

    over-the-counters, herbals, and vitamin/

    mineral/dietary (nutritional) supplements AND

    must contain the medications' name, dosage,

    frequency and route of administration.

    0028/226........................... Preventive Care and Screening: Tobacco use: American Medical

    Screening and Cessation Intervention: Association--Physician

    Percentage of patients aged 18 years and older Consortium for

    who were screened for tobacco use one or more Performance Improvement.

    times within 24 months AND who received

    cessation counseling intervention if

    identified as a tobacco user.

    0068/204........................... Ischemic Vascular Disease (IVD): Use of Aspirin National Committee for

    or Another Antithrombotic: Percentage of Quality Assurance.

    patients 18 years of age and older who were

    discharged alive for acute myocardial

    infarction (AMI), coronary artery bypass graft

    (CABG) or percutaneous coronary interventions

    (PCI) in the 12 months prior to the

    measurement period, or who had an active

    diagnosis of ischemic vascular disease (IVD)

    during the measurement period and who had

    documentation of use of aspirin or another

    antithrombotic during the measurement period.

    0018/236........................... Controlling High Blood Pressure: Percentage of National Committee for

    patients 18-85 years of age who had a Quality Assurance

    diagnosis of hypertension and whose blood

    pressure was adequately controlled (=21 years who were Insights of Pennsylvania/

    previously diagnosed with or currently have an Mathematica.

    active diagnosis of clinical atherosclerotic

    cardiovascular disease (ASCVD); OR adult

    patients aged >=21 years with a fasting or

    direct Low-Density Lipoprotein Cholesterol

    (LDL-C) level >=190 mg/dL; OR patients aged 40-

    75 years with a diagnosis of diabetes with a

    fasting or direct Low-Density Lipoprotein

    Cholesterol (LDL-C) level of 70-189 mg/dL who

    were prescribed or are already on statin

    medication therapy during the measurement

    period.

    This is a new measure described in Table 23

    above.

    ----------------------------------------------------------------------------------------------------------------

    Table 28--Diabetic Retinopathy Measures Group for 2016 and Beyond

    ----------------------------------------------------------------------------------------------------------------

    NQF/PQRS Measure title and description Measure developer

    ----------------------------------------------------------------------------------------------------------------

    0059/001........................... Diabetes: Hemoglobin A1c Poor Control: National Committee for

    Percentage of patients 18-75 years of age with Quality Assurance.

    diabetes who had hemoglobin A1c >9.0% during

    the measurement period.

    0088/018........................... Diabetic Retinopathy: Documentation of Presence American Medical

    or Absence of Macular Edema and Level of Association-Physician

    Severity of Retinopathy: Percentage of Consortium for

    patients aged 18 years and older with a Performance Improvement/

    diagnosis of diabetic retinopathy who had a National Committee for

    dilated macular or fundus exam performed which Quality Assurance.

    included documentation of the level of

    severity of retinopathy and the presence or

    absence of macular edema during one or more

    office visits within 12 months.

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    0089/019........................... Diabetic Retinopathy: Communication with the American Medical

    Physician Managing Ongoing Diabetes Care: Association-Physician

    Percentage of patients aged 18 years and older Consortium for

    with a diagnosis of diabetic retinopathy who Performance Improvement/

    had a dilated macular or fundus exam performed National Committee for

    with documented communication to the physician Quality Assurance.

    who manages the ongoing care of the patient

    with diabetes mellitus regarding the findings

    of the macular or fundus exam at least once

    within 12 months.

    0055/117........................... Diabetes: Eye Exam: Percentage of patients 18 National Committee for

    through 75 years of age with a diagnosis of Quality Assurance.

    diabetes (type 1 and type 2) who had a retinal

    or dilated eye exam by an eye care

    professional in the measurement period or a

    negative retinal or dilated eye exam (negative

    for retinopathy) in the year prior to the

    measurement period.

    0419/130........................... Documentation of Current Medications in the Centers for Medicare &

    Medical Record: Percentage of visits for Medicaid Services/Quality

    patients aged 18 years and older for which the Insights of Pennsylvania.

    EP attests to documenting a list of current

    medications using all immediate resources

    available on the date of the encounter. This

    list must include ALL known prescriptions,

    over-the-counters, herbals, and vitamin/

    mineral/dietary (nutritional) supplements AND

    must contain the medications' name, dosage,

    frequency and route of administration.

    0028/226........................... Preventive Care and Screening: Tobacco Use: American Medical

    Screening and Cessation Intervention: Association-Physician

    Percentage of patients 18 years and older who Consortium for

    were screened for tobacco use one or more Performance Improvement.

    times within 24 months AND who received

    cessation counseling intervention if

    identified as a tobacco user.

    N/A/317............................ Preventive Care and Screening: Screening for Centers for Medicare &

    High Blood Pressure and Follow-Up Documented: Medicaid Services/Quality

    Percentage of patients aged 18 years and older Insights of Pennsylvania.

    seen during the reporting period who were

    screened for high blood pressure AND a

    recommended follow-up plan is documented based

    on the current blood pressure (BP) reading as

    indicated.

    ----------------------------------------------------------------------------------------------------------------

    Table 29--Multiple Chronic Conditions Measures Group for 2016 and Beyond

    ----------------------------------------------------------------------------------------------------------------

    NQF/PQRS Measure title and description Measure developer

    ----------------------------------------------------------------------------------------------------------------

    0326/047........................... Care Plan: Percentage of patients aged 65 years National Committee for

    and older who have an advance care plan or Quality Assurance/

    surrogate decision maker documented in the American Medical

    medical record or documentation in the medical Association-Physician

    record that an advance care plan was discussed Consortium for

    but the patient did not wish or was not able Performance Improvement.

    to name a surrogate decision maker or provide

    an advance care plan.

    0041/110........................... Preventive Care and Screening: Influenza American Medical

    Immunization: Percentage of patients aged 6 Association-Physician

    months and older seen for a visit between Consortium for

    October 1 and March 31 who received an Performance Improvement.

    influenza immunization OR who reported

    previous receipt of an influenza immunization.

    0421/128........................... Preventive Care and Screening: Body Mass Index Centers for Medicare &

    (BMI) Screening and Follow-Up Plan: Percentage Medicaid Services/Quality

    of patients aged 18 years and older with a BMI Insights of Pennsylvania.

    documented during the current encounter or

    during the previous six months AND with a BMI

    outside of normal parameters, a follow-up plan

    is documented during the encounter or during

    the previous six months of the current

    encounter.

    Normal Parameters: Age 65 years and older BMI

    >=23 and =18.5

    and 24 hours.

    0130/165........................... Coronary Artery Bypass Graft (CABG): Deep Society of Thoracic

    Sternal Wound Infection Rate: Percentage of Surgeons.

    patients aged 18 years and older undergoing

    isolated Coronary Artery Bypass Graft surgery

    who, within 30 days postoperatively, develop

    deep sternal wound infection involving muscle,

    bone, and/or mediastinum requiring operative

    intervention.

    0131/166........................... Coronary Artery Bypass Graft (CABG): Stroke: Society of Thoracic

    Percentage of patients aged 18 years and older Surgeons.

    undergoing isolated Coronary Artery Bypass

    Graft surgery who have a postoperative stroke

    (i.e., any confirmed neurological deficit of

    abrupt onset caused b