Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access to Identifiable Data for the Center for Medicare and Medicaid Innovation Models & Other Revisions to Part B for CY 2015

 
CONTENT

Federal Register, Volume 79 Issue 219 (Thursday, November 13, 2014)

Federal Register Volume 79, Number 219 (Thursday, November 13, 2014)

Rules and Regulations

Pages 67547-68010

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

FR Doc No: 2014-26183

Page 67547

Vol. 79

Thursday,

No. 219

November 13, 2014

Part II

Department of Health and Human Services

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

Centers for Medicare and Medicaid Services

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

42 CFR Parts 403, 405, 410, et al.

Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access to Identifiable Data for the Center for Medicare and Medicaid Innovation Models & Other Revisions to Part B for CY 2015; Final Rule

Page 67548

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 403, 405, 410, 411, 412, 413, 414, 425, 489, 495, and 498

CMS-1612-FC

RIN 0938-AS12

Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access to Identifiable Data for the Center for Medicare and Medicaid Innovation Models & Other Revisions to Part B for CY 2015

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

ACTION: Final rule with comment period.

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

SUMMARY: This major final rule with comment period 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. See the Table of Contents for a listing of the specific issues addressed in this rule.

DATES: Effective date: The provisions of this final rule are effective on January 1, 2015, with the exception of amendments to parts 412, 413, and 495 which are effective October 31, 2014.

Comment date: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on December 30, 2014.

Compliance date: The compliance date for new data collection requirements in Sec. 403.904(c)(8) is January 1, 2016.

ADDRESSES: In commenting, please refer to file code CMS-1612-FC. 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-1612-FC, P.O. Box 8013, Baltimore, MD 21244-8013.

Please allow sufficient time for mailed comments to be received before the close of the comment period.

3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1612-FC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

4. By hand or courier. If you prefer, you may deliver (by hand or courier) your written comments before the close of the comment period to either of the following addresses:

  1. 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.)

  2. 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, the sustainable growth rate, conscious sedation, or conversion factors.

    Kathy Kersell, (410) 786-2033, for issues related to direct practice expense inputs.

    Jessica Bruton, (410) 786-5991, for issues related to potentially misvalued services or work RVUs.

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

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

    Pam West, (410) 786-2302, for issues related to conditions for therapists in private practice or therapy caps.

    Ann Marshall, (410) 786-3059, for issues related to chronic care management.

    Marianne Myers, (410) 786-5962, for issues related to ambulance extender provisions.

    Amy Gruber, (410) 786-1542, for issues related to changes in geographic area designations for ambulance payment.

    Anne Tayloe-Hauswald, (410) 786-4546, for issues related to clinical lab fee schedule.

    Corinne Axelrod, (410) 786-5620, for issues related to Rural Health Clinics or Federally Qualified Health Centers.

    Renee Mentnech, (410) 786-6692, for issues related to access to identifiable data for the Centers for Medicare & Medicaid models.

    Marie Casey, (410) 786-7861 or Karen Reinhardt, (410) 786-0189, for issues related to local coverage determination process for clinical diagnostic laboratory tests.

    Frederick Grabau, (410) 786-0206, for issues related to private contracting/opt-out.

    David Walczak, (410) 786-4475, for issues related to payment policy for substitute physician billing arrangements (locum tenens).

    Melissa Heesters, (410) 786-0618, for issues related to reports of payments or other transfers of value to covered recipients.

    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.

    Alexandra Mugge, (410) 786-4457, for issues related to EHR incentive program.

    Patrice Holtz, (410) 786-5663, for issues related to comprehensive primary care initiative.

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

    Kimberly Spalding Bush, (410) 786-3232, for issues related to value-based modifier and improvements to physician feedback.

    Elizabeth Holland, (410) 786-1309, Medicare EHR Incentive Program (Medicare payment adjustments and hardship exceptions).

    Elisabeth Myers (CMS), (410) 786-4751, Medicare EHR Incentive Program (Medicare payment adjustments and hardship exceptions).

    SUPPLEMENTARY INFORMATION:

    Inspection of Public Comments: All comments received before the close of

    Page 67549

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

    Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.

    Table of Contents

    I. Executive Summary and Background

    1. Executive Summary

    2. Background

    3. Health Information Technology

      II. Provisions of the Final Rule With Comment Period for PFS

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

    5. Potentially Misvalued Services Under the Physician Fee Schedule

    6. Malpractice Relative Value Units (RVUs)

    7. Geographic Practice Cost Indices (GPCIs)

    8. Medicare Telehealth Services

    9. Valuing New, Revised and Potentially Misvalued Codes

    10. Establishing RVUs for CY 2015

    11. Chronic Care Management (CCM)

      I. Therapy Caps for CY 2015

    12. Definition of Colorectal Cancer Screening Tests

    13. Payment of Secondary Interpretation of Images

      L. Conditions Regarding Permissible Practice Types for Therapists in Private Practice

    14. Payments for Practitioners Managing Patients on Home Dialysis

    15. Sustainable Growth Rate

      III. Other Provisions of the Final Rule With Comment Period Regulation

    16. Ambulance Extender Provisions

    17. Changes in Geographic Area Delineations for Ambulance Payment

    18. Clinical Laboratory Fee Schedule

    19. Removal of Employment Requirements for Services Furnished ``Incident to'' Rural Health Clinic (RHC) and Federally Qualified Health Center (FQHC) Visits

    20. Access to Identifiable Data for the Center for Medicare and Medicaid Innovation Models

    21. Local Coverage Determination Process for Clinical Diagnostic Laboratory Tests

    22. Private Contracting/Opt-Out

    23. Solicitation of Comments on the Payment Policy for Substitute Physician Billing Arrangements

      I. Reports of Payments or Other Transfers of Value to Covered Recipients

    24. Physician Compare Web Site

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

      Physician Quality Reporting System

      L. Electronic Health Record (EHR) Incentive Program

    26. Medicare Shared Savings Program

    27. Value-Based Payment Modifier and Physician Feedback Program

    28. Establishment of the Federally Qualified Health Center Prospective Payment System (FQHC PPS)

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

    30. Interim Final Revisions to the Electronic Health Record (EHR) Incentive Program

      IV. Collection of Information Requirements

      V. Response to Comments

      VI. Waiver of Proposed Rulemaking and Waiver of Delay in Effective Date

      VII. Regulatory Impact Analysis

      Regulations Text

      Acronyms

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

      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

      Page 67550

      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

      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 final rule with comment period 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 2015 PFS final rule with comment period, refer to item CMS-1612-FC. 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.henson1@cms.hhs.gov.

      CPT (Current Procedural Terminology) Copyright Notice

      Throughout this final rule with comment period, we use CPT codes and descriptions to refer to a variety of services. We note that CPT codes and descriptions are copyright 2013 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

    31. Executive Summary

      1. Purpose

      This major final rule with comment period revises payment polices under the Medicare Physician Fee Schedule (PFS) and makes other policy changes related to Medicare Part B payment. These changes are applicable to services furnished in CY 2015.

      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, incorporating geographic adjustments to reflect the variations in the costs of furnishing services in different geographic areas. In this major final rule with comment period, we establish RVUs for CY 2015 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 final rule with comment period includes discussions and proposals regarding:

      Misvalued PFS Codes.

      Telehealth Services.

      Chronic Care Management Services.

      Establishing Values for New, Revised, and Misvalued Codes.

      Updating the Ambulance Fee Schedule regulations.

      Changes in Geographic Area Delineations for Ambulance Payment.

      Updating the--

      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 final rule with comment period is economically significant. For a detailed discussion of the economic impacts, see section VII. of this final rule with comment period.

    32. 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 final rule with comment period, 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

  3. 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

    Page 67551

    cooperative agreement with the Department of Health and Human Services (HHS). In constructing the code-specific vignettes used in determining the original physician work RVUs, Harvard worked with panels of experts, both inside and outside the federal government, and obtained input from numerous physician specialty groups.

    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.

  4. 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.

  5. 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 final rule with comment period.

  6. 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.

    With regard to MP RVUs, we completed five-year reviews of MP that were effective in CY 2005 and CY 2010. This final rule with comment period establishes a five-year review for CY 2015.

    Page 67552

    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.

  7. Application of Budget Neutrality To Adjustments of RVUs

    As described in section VI.C. of this final rule with comment period, 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 physicians' 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 physician work, PE, and MP in an area compared to the national average costs for each component. (See section II.D. of this final rule with comment period 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 CF for a given year is calculated using (a) the productivity-adjusted increase in the Medicare Economic Index (MEI) and (b) the Update Adjustment Factor (UAF), which is calculated by taking into account the Medicare Sustainable Growth Rate (SGR), an annual growth rate intended to control growth in aggregate Medicare expenditures for physicians' services, and the allowed and actual expenditures for physicians' services. 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

    The CY 2014 PFS final rule with comment period (78 FR 74230) implemented changes to the PFS and other Medicare Part B payment policies. It also finalized many of the CY 2013 interim final RVUs and established interim final RVUs for new and revised codes for CY 2014 to ensure that our payment system is updated to reflect changes in medical practice, coding changes, and the relative values of services. It also implemented section 635 of the American Taxpayer Relief Act of 2012 (Pub. L. 112-240, enacted on January 2, 2013) (ATRA), which revised the equipment utilization rate assumption for advanced imaging services furnished on or after January 1, 2014.

    Also, in the CY 2014 PFS final rule with comment period, we announced the following for CY 2014: the total PFS update of -20.1 percent; the initial estimate for the SGR of -16.7 percent; and a CF of $27.2006. These figures were calculated based on the statutory provisions in effect on November 27, 2013, when the CY 2014 PFS final rule with comment period was issued.

    The Pathway for SGR Reform Act of 2013 (Pub. L. 113-67, enacted on December 26, 2013) established a 0.5 percent update to the PFS CF through March 31, 2014 and the Protecting Access to Medicare Act of 2014 (Pub. L. 113-93, enacted on April 1, 2014) (PAMA) extended this 0.5 percent update through December 31, 2014. As a result, the CF for CY 2014 that was published in the CY 2014 final rule with comment period (78 FR 74230) was revised to $35.8228 for services furnished on or after January 1, 2014 and on or before December 31, 2014. The PAMA provides for a 0.0 percent update to the PFS for services furnished on or after January 1, 2015 and on or before March 31, 2015.

    The Pathway for SGR Reform Act extended through March 31, 2014 several provisions of Medicare law that would have otherwise expired on December 31, 2013. The PAMA extended these same provisions further through March 31, 2015. A list of these provisions follows.

    The 1.0 floor on the work geographic practice cost index

    The exceptions process for outpatient therapy caps

    The manual medical review process for therapy services

    The application of the therapy caps and related provisions to services furnished in HOPDs

    In addition, section 220 of the PAMA included several provisions affecting the valuation process for services under the PFS. Section 220(a) of the PAMA amended section 1848(c)(2) of the Act to add a new subparagraph (M). The new subparagraph (M) provides that the Secretary may collect or obtain information from any eligible professional or any other source on the resources directly or indirectly related to furnishing services for which payment is made under the PFS, and that such information may be used in the determination of relative values for services under the PFS. Such information may include the time involved in furnishing services; the amounts, types and prices of practice expense inputs; overhead and accounting information for practices of physicians and other suppliers, and any other elements that would improve the valuation of services under the PFS. This information may be collected or obtained through surveys of physicians or other suppliers, providers of services, manufacturers, and vendors; surgical logs, billing systems, or other practice or facility records; EHRs; and any other mechanism determined appropriate by the Secretary. If we use this information, we are required to disclose the source and use of the information in rulemaking, and to make available aggregated information that does not disclose individual eligible professionals, group practices, or information obtained pursuant to a nondisclosure agreement. Beginning with fiscal year 2014, the Secretary may compensate eligible professionals for submission of data.

    Page 67553

    Section 220(c) of the PAMA amended section 1848(c)(2)(K)(ii) of the Act to expand the categories of services that the Secretary is directed to examine for the purpose of identifying potentially misvalued codes. The nine new categories are as follows:

    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 PE RVUs.

    Codes with high cost supplies.

    (See section II.B. of this final rule with comment period for more information about misvalued codes.).

    Section 220(i) of the PAMA also requires the Secretary to make publicly available the information we considered when establishing the multiple procedure payment reduction (MPPR) policy for the professional component of advanced imaging procedures. The policy reduces the amount paid for the professional component when two advanced imaging procedures are furnished in the same session. The policy was effective for individual physicians on January 1, 2012 and for physicians in the same group practice on January 1, 2013.

    In addition, section 220 of the PAMA includes other provisions regarding valuation of services under the PFS that take effect in future years. Section 220(d) of the PAMA establishes an annual target from CY 2017 through CY 2020 for reductions in PFS expenditures resulting from adjustments to relative values of misvalued services. The target is calculated as 0.5 percent of the estimated amount of expenditures under the fee schedule for the year. If the net reduction in expenditures for the year is equal to or greater than the target for the year, the funds shall be redistributed in a budget-neutral manner within the PFS. The amount by which such reduced expenditures exceed the target for the year shall be treated as a reduction in expenditures for the subsequent year, for purposes of determining whether the target has or has not been met. The legislation includes an exemption from budget neutrality of reduced expenditures if the target is not met. Other provisions of section 220 of the PAMA include a 2-year phase-in for reductions in RVUs of at least 20 percent for potentially misvalued codes that do not involve coding changes, and certain adjustments to the fee schedule areas in California. These provisions will be addressed as we implement them in future rulemaking.

    On March 5, 2014, we submitted to MedPAC an estimate of the SGR and CF applicable to Medicare payments for physicians' services for CY 2015, as required by section 1848(d)(1)(E) of the Act. The actual values used to compute physician payments for CY 2015 will be based on later data and are scheduled to be published by November 1, 2014, as part of the CY 2015 PFS final rule with comment period.

    1. Health Information Technology

      The Department of Health and Human Services (HHS) believes all patients, their families, and their health care providers should have consistent and timely access to patient health information in a standardized format that can be securely exchanged between the patient, providers, and others involved in the patient's care. (HHS August 2013 Statement, ``Principles and Strategies for Accelerating Health Information Exchange,'' see http://www.healthit.gov/sites/default/files/acceleratinghieprinciples_strategy.pdf) HHS is committed to accelerating health information exchange (HIE) through the use of safe, interoperable health information technology (health IT), including electronic health records (EHRs), across the broader care continuum through a number of initiatives: (1) Alignment of incentives and payment adjustments to encourage provider adoption and optimization of health IT and HIE services through Medicare and Medicaid payment policies; (2) adoption of common standards and certification requirements for interoperable HIT; (3) support for privacy and security of patient information across all HIE-focused initiatives; and (4) governance of health information. These initiatives are designed to encourage HIE among health care providers, including professionals and hospitals eligible for the Medicare and Medicaid EHR Incentive Programs and those who are not eligible for the EHR Incentive Programs, and are designed to improve care delivery and coordination across the entire care continuum. For example, the Transition of Care Measure #2 in Stage 2 of the Medicare and Medicaid EHR Incentive Programs requires HIE to share summary records for more than 10 percent of care transitions. In addition, to increase flexibility in the Office of the National Coordinator for Health Information Technology's (ONC) regulatory certification structure, ONC expressed in the 2014 Edition Release 2 final rule (79 FR 54472-73) an intent to propose future changes to the ONC HIT Certification Program that would permit more efficient certification of health IT for other health care settings, such as long-term and post-acute care and behavioral health settings.

      We believe that health IT that incorporates usability features and has been certified to interoperable standards can effectively and efficiently help all providers improve internal care delivery practices, support management of patient care across the continuum, and support the reporting of electronically specified clinical quality measures (eCQMs).

      II. Provisions of the Proposed Rule for PFS

    2. Resource-Based 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 physician's 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 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.

      Page 67554

      2. Practice Expense Methodology

  8. 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).

  9. 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).

  10. 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 final rule with comment period describes the current data sources for specialty-specific indirect costs used in our PE calculations. We allocated the 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 physician 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

    Page 67555

    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.

  11. 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.

  12. 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.)

  13. 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).

    (1) 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.

    (2) 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. This is the product of the current aggregate PE (direct and indirect) RVUs, the CF, and the average direct PE percentage from the survey data used for calculating the PE/HR by specialty.

    Step 3: Calculate the aggregate pool of direct PE costs for use in ratesetting. This is the product of the aggregated 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 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.

    (3) 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.

    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

    Page 67556

    the current aggregate pool of PE RVUs 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.

    (4) 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 current pool of PE RVUs. 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.)

    (5) 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.

    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

    Page 67557

    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 only Preoperative Intraoperative Preoperative

    Percentages on the payment Intraoperative

    files used by Medicare portion.

    contractors to process

    Medicare claims.

    55............................ Postoperative Care only. Postoperative Percentage on Postoperative portion.

    the payment files used by

    Medicare contractors to

    process Medicare claims.

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

    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 (MPPR). 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 the average allowed charge is used when simulating RVUs, and therefore, includes all adjustments. A time adjustment of 33 percent is made only for medical direction of two to four cases since that is the only situation where time units are duplicative.

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

    (6) 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)caret 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.

    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. We solicited comments regarding reliable data on maintenance costs that vary for particular equipment items. We received several comments about variable maintenance costs, which we will consider in future rulemaking. We note, however, that we do not believe that high-

    level summary data from informal surveys constitutes reliable data. Rather than assertions that a particular maintenance rate is typical, multiple invoices containing equipment prices that are accompanied by maintenance contracts would provide support for a maintenance cost other than our currently assumed 5 percent. We continue to seek reliable data about variable maintenance costs, as we consider adjustments to our methodology to accommodate variable maintenance costs.

    Per-use Equipment Costs: Several stakeholders have also suggested that our PE methodology should incorporate usage fees and other per-use equipment costs as direct costs. We also solicited comment on adjusting our cost formula to include equipment costs that do not vary based on the equipment time. We received a comment that addressed how to incorporate usage fees and other per-use equipment costs into our methodology, and received several comments that addressed how we should reclassify the anomalous supply inputs removed from the direct PE database. We will consider these comments in future rulemaking, including the way these anomalous supply inputs fit in to any future proposals related to per-use costs.

    Interest Rate: In the CY 2013 final rule with comment period (77 FR 68902), we updated the interest rates used in

    Page 67558

    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 67559

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

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

    99213 33533 93000 93005 93010

    Office CABG, 71020 71020-TC 71020-26 ECG, ECG, ECG,

    Factor (CF) (2nd part) Step Source Formula visit, arterial, Chest x- Chest x- Chest x- Complete, Tracing Report

    est non- single ray non- ray, non- ray, non- non- non- non-

    facility facility facility facility facility facility facility facility

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

    (1) Labor cost (Lab)................ Step 1................. AMA................... ................. 13.32 77.52 5.74 5.74 ......... 5.10 5.10 .........

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

    (3) Equipment cost (Eqp)............ Step 1................. AMA................... ................. 0.17 0.58 6.92 6.92 ......... 0.09 0.09 .........

    (4) Direct cost (Dir)............... Step 1................. ...................... =(1) (2) (3) 16.48 85.45 13.19 13.19 ......... 6.38 6.38 .........

    (5) Direct adjustment (Dir. Adj.)... Steps 2-4.............. See footnote*......... ................. 0.5898 0.5898 0.5898 0.5898 0.5898 0.5898 0.5898 0.5898

    (6) Adjusted Labor.................. Steps 2-4.............. =Labor * Dir Adj...... =(1)*(5) 7.86 45.72 3.39 3.39 ......... 3.01 3.01 .........

    (7) Adjusted Supplies............... Steps 2-4.............. =Eqp * Dir Adj........ =(2)*(5) 1.76 4.33 0.31 0.31 ......... 0.70 0.70 .........

    (8) Adjusted Equipment.............. Steps 2-4.............. =Sup * Dir Adj........ =(3)*(5) 0.10 0.34 4.08 4.08 ......... 0.05 0.05 .........

    (9) Adjusted Direct................. Steps 2-4.............. ...................... =(6) (7) (8) 9.72 50.40 7.78 7.78 ......... 3.77 3.77 .........

    (10) Conversion Factor (CF)......... Step 5................. PFS................... ................. 35.82 35.82 35.82 35.82 35.82 35.82 35.82 35.82

    (11) Adj. labor cost converted-..... Step 5................. =(Lab * Dir Adj)/CF... =(6)/(10) 0.22 1.28 0.09 0.09 ......... 0.08 0.08 .........

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

    (13) Adj. equipment cost converted.. Step 5................. =(Eqp * Dir Adj)/CF... =(8)/(10) ......... 0.01 0.11 0.11 ......... ......... ......... .........

    (14) Adj. direct cost converted..... Step 5................. ...................... =(11) (12) (13) 0.27 1.41 0.22 0.22 ......... 0.11 0.11 .........

    (15) Work RVU....................... Setup File............. PFS................... ................. 0.97 33.75 0.22 ......... 0.22 0.17 ......... 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 0.82 6.67 0.53 0.53 ......... 0.26 0.26 .........

    (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 0.31 0.09 0.22 0.25 0.08 0.17

    (22) Indirect Allocator (1st 2nd). Step 8................. ...................... =(19) (21) 1.79 40.42 0.84 0.62 0.22 0.51 0.34 0.17

    (23) Indirect Adjustment (Ind. Adj.) Steps 9-11............. See Footnote**........ ................. 0.3813 0.3813 0.3813 0.3813 0.3813 0.3813 0.3813 0.3813

    (24) Adjusted Indirect Allocator.... Steps 9-11............. =Ind Alloc * Ind Adj.. ................. 0.68 15.41 0.32 0.24 0.08 0.20 0.13 0.06

    (25) Ind. Practice Cost Index (IPCI) Steps 12-16............ ...................... ................. 1.07 0.75 0.99 0.99 0.99 0.91 0.91 0.91

    (26) Adjusted Indirect.............. Step 17................ = Adj.Ind Alloc * PCI. =(24)*(25) 0.73 11.59 0.32 0.24 0.08 0.18 0.12 0.06

    (27) Final PE RVU................... Step 18................ =(Adj Dir Adj Ind) * =((14) (26)) * 1.01 13.04 0.54 0.46 0.08 0.29 0.23 0.06

    Other Adj. Other Adj)

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

    Note: PE RVUs in Table 5, row 27, may not match Addendum B due to rounding.

    * 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.

    Note: The use of any particular conversion factor (CF) in Table 5 to illustrate the PE Calculation has no effect on the resulting RVUs.

    Note: The Other Adjustment includes an adjustment for the equipment utilization change.

    Page 67560

    3. Changes to Direct PE Inputs for Specific Services

    In this section, we discuss other CY 2015 revisions related to direct PE inputs for specific services. The final direct PE inputs are included in the final rule CY 2015 direct PE input database, which 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.html.

  14. RUC Recommendation for Monitoring Time following Moderate Sedation

    We received a recommendation from the RUC regarding appropriate clinical labor minutes for post-procedure moderate sedation monitoring and post-procedure monitoring. The RUC recommended 15 minutes of RN time for one hour of monitoring following moderate sedation and 15 minutes of RN time per hour for post-procedure monitoring (unrelated to moderate sedation). For 17 procedures listed in Table 5, the recommended clinical labor minutes differed from the clinical labor minutes in the direct PE database. We proposed to accept, without refinement, the RUC recommendation to adjust these clinical labor minutes as indicated in Table 5 as ``Change to Clinical Labor Time.''

    Table 5--Codes With Changes to Post-Procedure Clinical Labor Monitoring Time

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

    RUC

    recommended

    Current total post- Change to

    CPT Code monitoring procedure clinical labor

    time (min) monitoring time (min)

    time (min)

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

    32553........................................................... 30 60 30

    35471........................................................... 21 60 39

    35475........................................................... 60 30 -30

    35476........................................................... 60 30 -30

    36147........................................................... 18 30 12

    37191........................................................... 60 30 -30

    47525........................................................... 6 15 9

    49411........................................................... 30 60 30

    50593........................................................... 30 60 30

    50200........................................................... 15 60 45

    31625........................................................... 20 15 -5

    31626........................................................... 25 15 -10

    31628........................................................... 25 15 -10

    31629........................................................... 25 15 -10

    31634........................................................... 25 15 -10

    31645........................................................... 10 15 5

    31646........................................................... 10 15 5

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

    Comment: We received two comments supporting our proposal to accept the RUC recommendation, without refinement, to adjust the clinical labor minutes as indicated in Table 5. One commenter noted that the RUC recommendation was a more accurate reflection of the monitoring time, particularly for codes 50593 (Ablation, renal tumor(s), unilateral, percutaneous, cryotherapy) and 50200 (Renal biopsy; percutaneous, by trocar or needle), than the current time.

    Response: We appreciate commenters' support for our proposal. After consideration of comments received, we are finalizing our proposal to accept, without refinement, the RUC recommendation to adjust the clinical labor minutes as indicated in Table 5 as ``Change to Clinical Labor Time.''

  15. RUC Recommendation for Standard Moderate Sedation Package

    We received a RUC recommendation to modify PE inputs included in the standard moderate sedation package. Specifically, the RUC indicated that several specialty societies have pointed to the need for a stretcher during procedures for which moderate sedation is inherent in the procedure. Although the RUC did not recommend that we make changes to PE inputs for codes at this time, the RUC indicated that its future recommendations would include the stretcher as a direct input for procedures including moderate sedation.

    The RUC recommended three scenarios that it would use in the future to allocate the equipment time for the stretcher based on the procedure time and whether the stretcher would be available for other patients to use during a portion of the procedure. Although we appreciate the RUC's attention to the differences in the time required for the stretcher based on the time for the procedure, we believe that one of the purposes of standard PE input packages is to reduce the complexity associated with assigning appropriate PE inputs to individual procedures while, at the same time, maintaining relativity between procedures. Since we generally allocate inexpensive equipment items to the entire service period when they are likely to be unavailable for another use during the full service period, we believe it is preferable to treat the stretcher consistently across services. Therefore, we proposed to modify the standard moderate sedation input package to include a stretcher for the same length of time as the other equipment items in the moderate sedation package. The revised moderate sedation input package will be applied to relevant codes as we review them through future notice and comment rulemaking. In seeking comments on the proposal, we stated that it would be useful to hear stakeholders' views and the reasoning behind them on this issue, especially from those who think that the stretcher, as expressed through the allocation of equipment minutes, should be allocated with more granularity than the equipment costs that are allocated to other similar items.

    Comment: We received comments supporting our proposal to add the stretcher to the moderate sedation package, including support to include the stretcher for the same length of time as the other equipment items included in the moderate sedation package since it is used by the patient for the duration

    Page 67561

    of their recovery and not available to other patients during that time.

    Response: We appreciate the commenters' support for our proposal. After consideration of comments received, we are finalizing our proposal to add the stretcher to the moderate sedation package for the same length of time as the other equipment items in the moderate sedation package. We note that we will not apply this change retroactively, but will make the change to the moderate sedation package for codes being finalized for 2015, as well as interim final codes for 2015. For a detailed discussion of the specific codes impacted by this change, we refer readers to sections II.F. of this final rule with comment period.

  16. RUC Recommendation for Migration From Film to Digital Practice Expense Inputs

    The RUC provided a recommendation regarding the PE inputs for digital imaging services. Specifically, the RUC recommended that we remove a list of supply and equipment items associated with film technology since these items are no longer a typical resource input; these items are detailed in Table 6. 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. We received a description of the PACS system as part of the recommendation, which included both items that appear to be direct PE items and items for which indirect PE RVUs are allocated in the PE methodology. As we have previously indicated, items which are not clinical labor, medical supplies, or medical equipment, or are not individually allocable to a particular patient for a particular procedure, are not categorized as direct costs in the PE methodology. Since we did not receive any invoices for the PACS system prior to the proposed rule, we were unable to determine the appropriate pricing to use for the inputs. We proposed to accept the RUC recommendation to remove the film supply and equipment items, and to allocate minutes for a desktop computer (ED021) as a proxy for the PACS workstation as a direct expense. Specifically, for the 31 services that already contain ED021 (computer, desktop, w-monitor), we proposed to retain the time that is currently included in the direct PE input database. For the remaining services that are valued in the nonfacility setting, we proposed to allocate the full clinical labor intraservice time to ED021, except for codes without clinical labor, in which case we proposed to allocate the intraservice work time to ED021. For services valued only in the facility setting, we proposed to allocate the post-service clinical labor time to ED021, since the film supply and/or equipment inputs were previously associated with the post-

    service period.

    Table 6--RUC-Recommended Supply and Equipment Items Removed for Digital

    Imaging Services

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

    CMS Code Description

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

    SK013........................... computer media, dvd.

    SK014........................... computer media, floppy disk 1.44mb.

    SK015........................... computer media, optical disk 128mb.

    SK016........................... computer media, optical disk 2.6gb.

    SK022........................... film, 8inx10in (ultrasound, MRI).

    SK025........................... film, dry, radiographic, 8in x 10in.

    SK028........................... film, fluoroscopic 14 x 17.

    SK033........................... film, x-ray 10in x 12in.

    SK034........................... film, x-ray 14in x 17in.

    SK035........................... film, x-ray 14in x 36in.

    SK037........................... film, x-ray 8in x 10in.

    SK038........................... film, x-ray 8in x 10in (X-omat,

    Radiomat).

    SK086........................... video tape, VHS.

    SK089........................... x-ray developer solution.

    SK090........................... x-ray digitalization separator sheet.

    SK091........................... x-ray envelope.

    SK092........................... x-ray fixer solution.

    SK093........................... x-ray ID card (flashcard).

    SK094........................... x-ray marking pencil.

    SK098........................... film, x-ray, laser print.

    SM009........................... cleaner, x-ray cassette-screen.

    ED014........................... computer workstation, 3D

    reconstruction CT-MR.

    ED016........................... computer workstation, MRA post

    processing.

    ED023........................... film processor, PET imaging.

    ED024........................... film processor, dry, laser.

    ED025........................... film processor, wet.

    ED027........................... film processor, x-omat (M6B).

    ER018........................... densitometer, film.

    ER029........................... film alternator (motorized film

    viewbox).

    ER067........................... x-ray view box, 4 panel.

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

    We note that the RUC exempted certain procedures from its recommendation because (a) the dominant specialty indicated that digital technology is not yet typical or (b) the procedure only contained a single input associated with film technology, and it was determined that the sharing of images, but not actual imaging, may be involved in the service. However, we do not believe that the most appropriate approach in establishing relative values for services that involve imaging is to exempt services from the transition from film to digital PE inputs based on information reported by individual specialties. Although we understand that the migration from film technology to digital technology may progress at different paces for particular specialties, we do not have information to suggest that the migration is not occurring for all procedures that require the storage of images. Just as it was appropriate to use film inputs as a proxy for some services for which digital inputs were typical pending these changes in the direct PE input database, we believe it is appropriate to use digital inputs as a proxy for the services that may still use film, pending their migration to digital technology. In addition, since the RUC conducted its collection of information from the specialties over several years, we believe the migration process from film to digital inputs has likely continued over the time period during which the information was gathered, and that the digital PE inputs will reflect typical use of technology for most if not all of these services before the change to digital inputs would take effect beginning January 1, 2015.

    We noted that we believed that, for the sake of relativity, we should remove the equipment and supply inputs noted below from all procedures in the direct PE database, including those listed in Table 7. We sought comment on whether the computer workstation, which we proposed to use as a proxy for the PACS workstation, is the appropriate input for the services listed in Table 7, or whether an alternative input is a more appropriate reflection of direct PE costs.

    Table 7--Codes Containing Film Inputs But Excluded From the RUC

    Recommendation

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

    HCPCS Short descriptor

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

    21077........................... Prepare face/oral prosthesis.

    28293........................... Correction of bunion.

    61580........................... Craniofacial approach skull.

    61581........................... Craniofacial approach skull.

    61582........................... Craniofacial approach skull.

    61583........................... Craniofacial approach skull.

    61584........................... Orbitocranial approach/skull.

    61585........................... Orbitocranial approach/skull.

    61586........................... Resect nasopharynx skull.

    64517........................... N block inj hypogas plxs.

    64681........................... Injection treatment of nerve.

    70310........................... X-ray exam of teeth.

    77326........................... Brachytx isodose calc simp.

    77327........................... Brachytx isodose calc interm.

    77328........................... Brachytx isodose plan compl.

    91010........................... Esophagus motility study.

    91020........................... Gastric motility studies.

    91034........................... Gastroesophageal reflux test.

    91035........................... G-esoph reflx tst w/electrod.

    91037........................... Esoph imped function test.

    91038........................... Esoph imped funct test > 1hr.

    91040........................... Esoph balloon distension tst.

    91120........................... Rectal sensation test.

    91122........................... Anal pressure record.

    91132........................... Electrogastrography.

    91133........................... Electrogastrography w/test.

    92521........................... Evaluation of speech fluency.

    Page 67562

    92523........................... Speech sound lang comprehend.

    92524........................... Behavioral qualit analys voice.

    92601........................... Cochlear implt f/up exam .

    92611........................... Motion fluoroscopy/swallow.

    92612........................... Endoscopy swallow tst (fees).

    92614........................... Laryngoscopic sensory test.

    92616........................... Fees w/laryngeal sense test.

    95800........................... Slp stdy unattended.

    95801........................... Slp stdy unatnd w/anal.

    95803........................... Actigraphy testing.

    95805........................... Multiple sleep latency test.

    95806........................... Sleep study unatt&resp efft.

    95807........................... Sleep study attended.

    95808........................... Polysom any age 1-3> param.

    95810........................... Polysom 6/> yrs 4/> param.

    95811........................... Polysom 6/>yrs cpap 4/> parm.

    95812........................... Eeg 41-60 minutes.

    95813........................... Eeg over 1 hour.

    95829........................... Surgery electrocorticogram.

    95950........................... Ambulatory eeg monitoring.

    95953........................... Eeg monitoring/computer.

    95954........................... Eeg monitoring/giving drugs.

    95955........................... Eeg during surgery.

    95956........................... Eeg monitor technol attended.

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

    96904........................... Whole body photography.

    G0270........................... Mnt subs tx for change dx.

    G0271........................... Group mnt 2 or more 30 mins.

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

    Finally, we noted that the RUC recommendation also indicated that, given the labor-intensive nature of reviewing all clinical labor tasks associated with film technology, these times would be addressed as these codes are reviewed. We agreed with the RUC that reviewing and adjusting the times for each code would be difficult and labor-

    intensive since the direct PE input database does not allow for a comprehensive adjustment of the clinical labor time based on changes in particular clinical labor tasks. To make broad adjustments such as this across codes, the PE database would need to contain the time associated with individual clinical labor tasks rather than reflecting only the sum of times for the pre-service period, service period, and post-

    service period, as it does now. We recognized this situation presents a challenge in implementing RUC recommendations such as this one, and makes it difficult to understand the basis of both the RUC's recommended clinical labor times and our refinements of those recommendations. Therefore, we stated that we were considering revising the direct PE input database to include task-level clinical labor time information for every code in the database. As an example, we referred readers to the supporting data files for the direct PE inputs, which include public use files that display clinical labor times as allocated to each individual clinical labor task for a sample of procedures. We displayed this information as we attempt to increase the transparency of the direct PE database. We stated that we hoped that this modification would enable us to more accurately allocate equipment minutes to clinical labor tasks in a more consistent and efficient manner. Given the number of procedures and the volume of information involved, we sought comments on the feasibility of this approach. We note that we did not propose to make any changes to PE inputs for CY 2015 based on this modification to the design of the direct PE input database.

    As discussed in section II.G. of this final rule with comment period, some of the RUC recommendations for 2015 included film items as practice expense inputs. For existing codes, the database from the proposed rule already included the PACS workstation proxy. However, for new services, as with the current items in the database, we have replaced the film items with the PACS workstation proxy. The codes affected by this change are listed in Table 8.

    Table 8--Codes Affected by Removal of Film Inputs

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

    HCPCS Short descriptor

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

    22510........................... Perq cervicothoracic inject.

    22511........................... Perq lumbosacral injection.

    22513........................... Perq vertebral augmentation.

    22514........................... Perq vertebral augmentation.

    62302........................... Myelography lumbar injection.

    62303........................... Myelography lumbar injection.

    62304........................... Myelography lumbar injection.

    62305........................... Myelography lumbar injection.

    71275........................... Ct angiography chest.

    72191........................... Ct angiograph pelv w/o&w/dye.

    72240........................... Myelography neck spine.

    72255........................... Myelography thoracic spine.

    72265........................... Myelography l-s spine.

    72270........................... Myelogphy 2/> spine regions.

    74174........................... Ct angio abd&pelv w/o&w/dye.

    74175........................... Ct angio abdom w/o & w/dye.

    74230........................... Cine/vid x-ray throat/esoph.

    76942........................... Echo guide for biopsy.

    93312........................... Echo transesophageal.

    93314........................... Echo transesophageal.

    93320........................... Doppler echo exam heart.

    93321........................... Doppler echo exam heart.

    93325........................... Doppler color flow add-on.

    93880........................... Extracranial bilat study.

    93882........................... Extracranial uni/ltd study.

    93886........................... Intracranial complete study.

    93888........................... Intracranial limited study.

    93895........................... Carotid intima atheroma eval.

    93925........................... Lower extremity study.

    93926........................... Lower extremity study.

    93930........................... Upper extremity study.

    93931........................... Upper extremity study.

    93970........................... Extremity study.

    93971........................... Extremity study.

    93975........................... Vascular study.

    93976........................... Vascular study.

    93978........................... Vascular study.

    93979........................... Vascular study.

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

    Comment: We received many comments on our proposal to remove the equipment and supply inputs associated with film technology from the direct PE database. In general, commenters supported our proposal to remove the film inputs from the direct PE database. Some commenters supported our use of the desktop computer as a proxy for the PACS workstation, but other commenters opposed using this item as a proxy. Commenters opposed to using the desktop computer as the proxy item stated that the PACS workstation was significantly more expensive and included greater functionality than a desktop computer. Some commenters opposed our proposal to maintain the current equipment time allocated to the computer desktop for the 31 services that already included this equipment item, suggesting that it was incorrect to eliminate the film inputs without proportionately increasing the proxy time for ED021. Some commenters requested a delay in implementation until stakeholders provide invoices or otherwise work with CMS to identify prices for the PACS items. Some commenters suggested CMS should develop a means to allocate digital technology costs to individual services, even if it is difficult to do so. Another commenter explained that it is difficult for stakeholders to obtain invoices that display prices for individual items, such as the PACS workstation, since the price of the particular items is often bundled with other related equipment and services. Many commenters urged CMS to work with stakeholders to obtain invoices, while other commenters requested that CMS accept the RUC recommendation regarding the PACS workstation.

    Response: We appreciate commenters' support for our proposal to incorporate the transition from film to digital imaging technology into the direct PE input database. With regard to the pricing of the PACS workstation, as with all inputs, we would prefer to use actual paid invoices to establish the input price. However, in the absence of invoices demonstrating the actual cost, we believe that use of a proxy to price the appropriate inputs, in this case the PACS workstation, is preferable to

    Page 67563

    continuing to use inputs that we know are no longer typical. We made the proposal to use the computer, desktop, w-monitor (ED021), priced at $2,501, as a proxy based on our assessment of similar resource costs between the item and the PACS workstation. Although some commenters stated that the item was not an appropriate proxy, these commenters did not provide any evidence to indicate that the resource costs are not similar or to suggest a more appropriate proxy. Nor were any paid invoices submitted. Absent such information, we continue to believe that using the proxy item is the best approach to incorporate the direct PE cost of the digital imaging technology.

    With regard to the 31 services that already included the desktop computer as an equipment input, we will include the desktop computer as a proxy for the PACS workstation using the same methodology as for the services that did not previously contain the desktop computer. To clearly differentiate the desktop computer proxy from the desktop computer currently included in these services, and to facilitate accurate replacement of this input when we do receive pricing information, we will create a new equipment item called ``desktop computer (proxy for PACS workstation),'' which will be allocated to each procedure using the methodology described above.

    Comment: Some commenters opposed our removal of the film inputs from services that were not included in the RUC recommendation, but did not provide a rationale for their opposition.

    Response: For the reasons we explained in making the proposal and reiterate above, we continue to believe that it is appropriate to remove these items from the direct PE database.

    Comment: Some commenters provided specific suggestions regarding the use of digital inputs should CMS decide to move forward with the proposal. Commenters requested that for portable x-ray services, CMS include a flat plate receptor/image capture plate to capture the image, specialized software to process the image, and multiple high definition monitors used by the interpreting radiologist. Commenters provided an invoice for the image capture plate at a price of $25,600 indicating that this item replaces the film as the media to record the image.

    Response: We appreciate that commenters provided us with an invoice for the image capture plate. However, services furnished by portable x-

    ray providers are reported using the same procedure codes as services provided using fixed machines. Since the typical x-ray service is furnished using fixed equipment, we are not including the image capture plate that is associated with portable equipment as an input for the imaging procedure codes. We also do not believe that high definition monitors used by the interpreting radiologist are appropriately included in the technical component of imaging procedures; rather, these are indirect costs associated with the professional component of the service. Therefore, we are not including the high definition monitors as an input for these services. Finally, to determine whether the software is appropriately categorized as a direct PE input, we need more information about the functionality of the software, and whether it is used in furnishing the typical x-ray service (including services furnished using fixed machinery). Until we have information that supports the inclusion of this item as a direct cost, we will not include the software for x-ray services.

    Comment: Commenters were supportive of the increased transparency with regard to the direct PE inputs, but several commenters suggested that there may be more feasible approaches to break out the individual clinical labor tasks associated with each portion of the service (pre-

    service period, service period, and post-service period). The RUC suggested that we post all PE worksheets and supporting materials in code-order on our Web site. Other commenters did not suggest a specific alternative approach to providing detail for the individual clinical labor tasks.

    Response: We appreciate the RUC's suggestion regarding the posting of the PE worksheets, but we do not believe that this would enable us to accomplish a comprehensive cross-code analysis and refinement to clinical labor times within the direct PE input database to increase consistency for identical clinical labor tasks between codes. Since we did not receive other suggestions from commenters on an approach to break out the individual clinical labor tasks associated with each service period to enable us to conduct the necessary analysis, we will pursue the approach described in the proposed rule. We will consider the comments submitted and continue to work with interested stakeholders regarding the best approaches to displaying the supporting files. We note that public use files continue to be available in the same format as in previous years, but that additional public use files now display the clinical labor tasks for each service period, providing greater transparency and enabling comparisons across codes. We note that we have refined the file structure based on comments, and we continue to seek input on whether there are additional or alternative ways to display this information to enhance its clarity, and note that there are challenges inherent in the display of this information in a two-dimensional format. We refer readers to the public use files 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.html

  17. Inputs for Digital Mammography Services

    Mammography services are currently reported and paid using both CPT codes and G-codes. To meet the requirements of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA), we established G-codes for use beginning in CY 2002 to pay for mammography services using new digital technologies (G0202 screening mammography digital; G0204 diagnostic mammography digital; G0206 diagnostic mammography digital). We continued to use the CPT codes for mammography services furnished using film technology (77055 (Mammography; unilateral); 77056 (Mammography; bilateral); 77057 (Screening mammography, bilateral (2-view film study of each breast)). As we discussed previously in this section, the RUC has recommended that all imaging codes, including mammography, be valued using digital rather than film inputs because the use of film is no longer typical. A review of Medicare claims data shows that the mammography CPT codes are billed extremely infrequently, and that the G-codes are billed for the vast majority of mammography claims, confirming the RUC's conclusion that the typical service uses digital technology. As such, we stated that we do not believe there is a reason to continue the separate CPT codes and G-codes for mammography services since both sets of codes would have the same values when priced based upon the typical digital technology. Accordingly, we proposed to delete the mammography G-codes beginning for CY 2015 and to pay all mammography using the CPT codes.

    We indicated that, although we believed that the CPT codes should now be used to report all mammography services, we had concerns about whether the current values for the CPT codes accurately reflect the resource inputs associated with furnishing the services. Because the CPT codes have not been recently reviewed and

    Page 67564

    significant technological changes have occurred since the current values were established, we did not believe it would be appropriate to retain the current values for the CPT codes. Therefore, we proposed to value the CPT codes using the RVUs previously established for the G-

    codes. We believed these values would be most appropriate since they were established to reflect the use of digital technology, which is now typical.

    As discussed in section II.B of this final rule with comment period, we proposed these CPT codes as potentially misvalued and requested that the RUC and other interested stakeholders review these services in terms of appropriate work RVUs, work time assumptions, and direct PE inputs. However, as discussed in section II.B. of this final rule with comment period, we will continue to maintain separate payment rates for film and digital mammography while we consider revaluation of all mammography services. For CY 2015, we will therefore maintain both the G-codes and CPT codes; we will continue using the 2014 RVUs from each of the following codes to price them for 2015: G0202, G0204, G0206, 77055, 77056, and 77057. 2015. We also note that we will continue to pay for film mammography services at the 2014 rates until we revalue the mammography services.

    We refer readers to section II.B. of this final rule with comment period, where we address comments received on this proposal.

  18. Radiation Treatment Vault

    In previous rulemaking (77 FR 68922, 78 FR 74346), we indicated that we included the radiation treatment vault as a direct PE input for several recently reviewed radiation treatment codes for the sake of consistency with its previous inclusion as a direct PE input for some other radiation treatment services, but that we intended to review the radiation treatment vault input and address whether or not it should be included in the direct PE input database for all services in future rulemaking. Specifically, we questioned whether it was consistent with the principles underlying the PE methodology to include the radiation treatment vault as a direct cost given that it appears to be more similar to building infrastructure costs than to medical equipment costs. In response to this discussion, we received comments and invoices from stakeholders who indicated that the vault should be classified as a direct cost. However, upon review of the information received, we believed that the specific structural components required to house the linear accelerator are similar in concept to components required to house other medical equipment such as expensive imaging equipment. In general, the electrical, plumbing, and other building specifications are often unique to the intended functionality of a given building, including costs that are attributable to the specific medical equipment housed in the building, but those building characteristics do not represent direct medical equipment costs in our established PE methodology. Therefore, we believed that the special building requirements indicated for the radiation treatment vault to house a linear accelerator do not represent a direct cost in our PE methodology, and that the vault construction is instead accounted for in the indirect PE methodology, just as the building and infrastructure costs are treated for other PFS services including those with specialized infrastructure costs to accommodate specific equipment. Therefore, we proposed to remove the radiation treatment vault as a direct PE input from the radiation treatment procedures listed in Table 9, because we believed that the vault is not, itself, medical equipment; and therefore, it is accounted for in the indirect PE methodology.

    Table 9--HCPCS Codes Affected by Proposed Removal of Radiation Treatment

    Vault

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

    HCPCS Short descriptor

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

    77373........................... Sbrt delivery.

    77402........................... Radiation treatment delivery.

    77403........................... Radiation treatment delivery.

    77404........................... Radiation treatment delivery.

    77406........................... Radiation treatment delivery.

    77407........................... Radiation treatment delivery.

    77408........................... Radiation treatment delivery.

    77409........................... Radiation treatment delivery.

    77411........................... Radiation treatment delivery.

    77412........................... Radiation treatment delivery.

    77413........................... Radiation treatment delivery.

    77414........................... Radiation treatment delivery.

    77416........................... Radiation treatment delivery.

    77418........................... Radiation tx delivery imrt.

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

    Comment: We received many comments regarding our proposal to remove the radiation treatment vault as a direct cost from the radiation treatment delivery codes. Although one commenter supported the proposal, most commenters opposed the proposal. In general, commenters reiterated their rationale for inclusion of the vault as a direct practice expense input, asserting that the vault is necessary for the functioning of the equipment, serves a unique medical need, cannot be separated from the treatment delivered by the linear accelerator, and cannot be repurposed for another use. Commenters also stated that the Internal Revenue Code treats the vault as medical equipment that is separately depreciable from the building itself. For the most part, commenters objected to the removal of the vault given the context of declining Medicare payment for radiation oncology services over the past few years, or in conjunction with the revised radiation treatment code set. Specifically, several commenters suggested that stakeholders cannot provide meaningful comment about the impact of the vault proposal in the context of other pending changes. Some commenters requested a phase-in of any decrease in payment so that providers of radiation therapy services have an opportunity to adjust their practice costs. Several commenters also suggested that the change in payment could exacerbate problems in access to oncology services for Medicare patients.

    Response: We appreciate commenters' concerns regarding the proposal to remove the vault as a direct practice expense input. We understand the essential nature of the vault in the provision of radiation therapy services and its uniqueness to a particular piece of medical equipment but are not convinced that either of these factors leads to the conclusion that the vault should be considered medical equipment for purposes of the PE methodology under the PFS. We appreciate the information commenters provided regarding the IRS treatment of the vault under tax laws, but the purposes and goals of the tax code and the PFS PE methodology are different, and, as such, attempts to draw parallels between the two are not necessarily instructive or relevant. We are not finalizing our proposal at this time, but intend to further study the issues raised by the vault and how it relates to our PE methodology.

    Comment: A commenter noted that removing the vault as a direct cost also reduces the amount of indirect PE allocated for these procedures, and that this proposal does not shift the vault from direct PE to indirect PE, but rather drops the cost of the vault entirely. Another commenter stated that since the pool of indirect PE RVUs associated with radiation oncology services is fixed, the issue in question is how the indirect costs involved in furnishing treatment services compare to the indirect costs in providing other radiation oncology services.

    Response: We understand the concerns of commenters regarding the importance of ensuring that the costs related to the vault are included in the

    Page 67565

    PE methodology. We want to point out, however, that within the established PE methodology, the allocation of indirect PE to individual codes has significant impact on the PE RVUs that determine Medicare payment for individual services. In other words, we believe it is important for stakeholders to recognize that practice expense costs not included in the direct PE input database contribute to the development of PE RVUs through the data used to allocate indirect PE RVUs. We also want to point out that the pool of indirect PE RVUs is not fixed at the specialty level. Rather, the pool of indirect costs under the entire PFS is maintained from year to year, as delineated in step 11 of the PE methodology above. Therefore, changes in the allocation of indirect PE for particular PFS services based on changes in either direct PE inputs, work RVUs, work time, or utilization data, impacts the amount of indirect PE allocated to all other PFS services, not just those furnished by specialties that furnish that service.

    After continued review of the issues pertaining to the vault in the context of the comments, we believe that these issues require further study. Therefore, at this time, we will continue to include the vault as a direct PE input for the services listed in Table 9.

  19. Clinical Labor Input Errors

    Subsequent to the publication of the CY 2014 PFS final rule with comment period, it came to our attention that, due to a clerical error, the clinical labor type for CPT code 77293 (Respiratory Motion Management Simulation (list separately in addition to code for primary procedure)) was entered as L052A (Audiologist) instead of L152A (Medical Physicist), which has a higher cost per minute. We proposed a correction to the clinical labor type for this service.

    Comment: Commenters appreciated our proposal to correct this error.

    Response: We appreciate commenters' support for our proposal, and are finalizing the assignment of clinical labor type L152A to code 77293 as proposed. The CY 2015 Direct Practice Expense Input database reflects this correction.

    In conducting a routine data review of the database, we also discovered that, due to a clerical error, the RN time allocated to CPT codes 33620 (Apply r&l pulm art bands), 33621 (Transthor cath for stent), and 33622 (Redo compl cardiac anomaly) was entered in the nonfacility setting, rather than in the facility setting where the code is valued. When a service is not valued in a particular setting, any inputs included in that setting are not included in the calculation of the PE RVUs for that service. Therefore, we proposed to move the RN time allocated to these procedures to the facility setting. The PE RVUs listed in Addendum B reflect these technical corrections.

    We did not receive any comments on this proposal; therefore, we are finalizing our proposal to move the RN time allocated to these procedures to the facility setting. The CY 2015 Direct Practice Expense Input database reflects this correction.

  20. Work Time

    Subsequent to the publication of the CY PFS 2014 final rule with comment period, several inconsistencies in the work time file came to our attention. First, for some services, the total work time, which is used in our PE methodology, did not equal the sum of the component parts (pre-service, intra-service, post-service, and times associated with global period visits). The times in the CY 2015 work time file reflect our corrected values for total work time. Second, for a subset of services, the values in the pre-positioning time, pre-evaluation time, and pre-scrub-dress-wait time, were inadvertently transposed. We note that this error had no impact on calculation of the total times, but has been corrected in the CY 2015 work time file. Third, minor discrepancies for a series of interim final codes were identified between the work time file and the way we addressed these codes in the preamble text. Therefore, we have made adjustments to the work time file to reflect the decisions indicated in the preamble text. The work time file is available on the CMS Web site under the supporting data files for the CY 2015 PFS final rule with comment period at http://www.cms.gov/PhysicianFeeSched/. Note that for comparison purposes, the CY 2014 work time file is located at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices-Items/CMS-1600-FC.html.

    Comment: A commenter supported our proposal to correct the work times associated with the procedures affected by this proposal.

    Response: We appreciate the commenter's support for our proposal. After consideration of the comment received, we are finalizing our proposal to adjust the work time file as proposed. The work time file is available on the CMS Web site under the supporting data files for the CY 2015 PFS final rule with comment period at http://www.cms.gov/

    PhysicianFeeSched/

  21. 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 2013, we received a request to update the price of SD216 (catheter, balloon, esophageal or rectal (graded distention test)) from $217 to $237.50. We also received a request to update the price of SL196 (kit, HER-2/neu DNA Probe) from $105 to $144.50. We received invoices that documented updated pricing for each of these supply items. We proposed to increase the price associated with these supply items.

    We continue to believe it is important to maintain a periodic and transparent process to update the price of items to reflect typical market prices in our ratesetting methodology, and we continue to study the best way to improve our current process. We remind stakeholders that we have difficulty obtaining accurate pricing information. The goal of the current transparent process is to offer the opportunity for the community to both request supply price updates by providing us copies of paid invoices, and to object to proposed changes in price inputs for particular items by providing additional information about prices available to the practitioner community. We remind stakeholders that PFS payment rates are developed within a budget neutral, relative value system, and any increases in price inputs for particular supply items result in corresponding decreases to the relative values of all other direct PE inputs.

    We also received a RUC recommendation to update the prices associated with two supply items. Specifically, the RUC recommended that we increase the price of SA042 (pack, cleaning and disinfecting, endoscope) from $15.52 to $17.06 to reflect the addition of supply item SJ009 (basin, irrigation) to the pack, and increase the price of SA019 (kit, IV starter) from $1.37 to $1.60 to reflect the addition of supply item SA044 (underpad 2 ft. x 3 ft. (Chux)) to the kit. We proposed to update the prices for both of these items based on these recommendations.

    Comment: We received several comments regarding our concern about obtaining accurate pricing information for equipment and supply items included in the direct PE database. The RUC indicated that it would continue to work with specialty societies to obtain

    Page 67566

    paid invoices. A commenter suggested that a sample of paid invoices be obtained from practices and submitted with the PE materials to the RUC, or directly to CMS. Another commenter expressed concern regarding CMS's assertion that invoices are difficult to obtain, given that the RUC process collects lists of resources required to furnish services in the physician office using a standardized process that is typically accompanied by invoices. Another commenter stated that CMS used only the lowest-cost invoice for a particular equipment item since the other invoices included ``soft costs,'' and that CMS should establish an approach that would allow invoices to be used even if they contain ``soft costs.''

    Response: We appreciate the RUC's assistance in obtaining paid invoices from the specialty societies. These invoices are helpful in pricing inputs. We disagree that we use the lowest-cost invoice because it had the lowest cost; rather, we often use the lowest-cost invoice because we do not have a method to use invoices that include costs that are not included as part of the equipment costs, so called ``soft costs,'' within the PE methodology. We do not believe it would serve accuracy or relativity to include as part of the pricing inputs ``soft costs'' that increase the price of particular supply or equipment items. We would welcome further input on potential approaches for ``backing out'' these costs.

    Comment: One commenter disagreed with CMS's position that the RUC PE Subcommittee's review results in biased or inaccurate resource input costs because the prices are largely maintained in the direct PE input database by CMS.

    Response: Although we did not raise this point in the CY 2015 PFS proposed rule, we refer readers to our discussion in previous rulemaking (for example, the CY 2011 PFS final rule with comment period at 75 FR 73250 and the CY 2014 PFS final rule with comment period at 78 FR 74246) regarding issues associated with obtaining appropriate prices for medical equipment and supply items included in the direct PE database. We note that the RUC provides recommendations regarding the use of particular items in furnishing a service, but does not provide CMS with recommendations regarding the prices of direct PE item. Without assigning a price, the input cannot be factored in to our PE RVU methodology. Our price information is almost exclusively anecdotal, and generally updated only through voluntary submission of a small number of invoices from the same practitioners that furnish and are paid for the services that use the particular inputs. Therefore, we continue to believe there is potential for bias in the information we receive.

    Comment: In its comment, the RUC suggested that an annual CMS review of paid invoices for high-cost supplies would be appropriate. A commenter referenced comments made on the CY 2014 PFS final rule with comment period, and expressed agreement with those commenters that the provision of pricing information is sensitive because of issues involving proprietary pricing information and price negotiations for individual practitioners. This commenter also agreed with CMS that such information would be less sensitive if it confirmed inputs contained in the direct PE database. However, the commenter noted that requiring paid invoices from this point forward only partially addresses the concern since many existing inputs are not based on paid invoices; specifically, societies working on inputs for new, revised, or potentially misvalued services are disadvantaged in comparison to many existing inputs due to fee schedule relativity. The commenter suggested that CMS may need to undertake a comprehensive review of all direct PE inputs and obtain paid invoices to systematically address its concerns.

    Response: We share commenters' concerns that codes that are being reviewed may be disadvantaged relative to codes that contain input prices that may not be based on paid invoices; and note that we rely on the public process to ensure continued relativity within the direct PE inputs. We encourage interested stakeholders to review updates to prices, as well as prices for new items, to ensure that they appear reasonable and current, and to provide us with updated pricing information, particularly regarding high cost supplies that have a greater impact on relativity. We refer readers to section II.F. of this final rule with comment period, in which we detail price updates, as well as establish new prices, for inputs included in new, revised, and potentially misvalued codes.

    Comment: We received some comments in support of our proposal to update the price for SL196 (kit, HER-2/neu DNA Probe).

    Response: We appreciate the commenters' support for our proposal to update the price for SL196. After publication of our proposal, we obtained new information suggesting that further study of the price of this item is necessary before proceeding to update the input price. Therefore, we are not finalizing our proposal to update the price for SL196, and will consider this matter in future rulemaking.

    Comment: We did not receive any comments regarding our proposal to update the price for of SD216 (catheter, balloon, esophageal or rectal (graded distention test)).

    Response: We are finalizing the price updates for SD216.

    Comment: We received comments in support of the price update to SA019 (kit, IV starter) and SA042 (pack, cleaning and disinfecting, endoscope).

    Response: We appreciate the commenters' support for our proposal to update the price for SA019 and SA042. After consideration of comments received, we are finalizing the price updates for SA019 and SA042.

  22. New Standard Supply Package for Contrast Imaging

    The RUC recommended creating a new direct PE input standard supply package ``Imaging w/contrast, standard package'' for contrast enhanced imaging, with a price of $6.82. This price reflects the combined prices of the medical supplies included in the package; these items are listed in Table 10. We proposed to accept this recommendation, but sought comment on whether all of the items included in the package are used in the typical case. The CY 2015 direct PE database reflects this change and is available on the CMS Web site under the supporting data files for the CY 2015 PFS proposed rule at http://www.cms.gov/PhysicianFeeSched/.

    Table 10--Standard Contrast Imaging Supply Package

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

    SCMS supply

    Medical supply description code Unit Quantity Price

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

    Kit, IV starter..................... SA019 Kit..................... 1 $1.60

    Gloves, non-sterile................. SB022 Pair.................... 1 0.084

    Page 67567

    Angiocatheter 14g-24g............... SC001 Item.................... 1 1.505

    Heparin lock........................ SC012 Item.................... 1 0.917

    IV tubing (extension)............... SC019 Foot.................... *3 1.590

    Needle, 18-27g...................... SC029 Item.................... 1 0.089

    Syringe 20ml........................ SC053 Item.................... 1 0.558

    Sodium chloride 0.9% inj. SH068 Item.................... 1 0.700

    bacteriostatic (30ml uou).

    Swab-pad, alcohol................... SJ053 Item.................... 1 0.013

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

    Total........................... ................ ........................ .............. 7.06

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

    * The price for SC019 (IV tubing, (extension)) is $0.53 per foot.

    Comment: Commenters supported our proposal to create the standard supply package for contrast imaging. Some commenters expressed concern that the proposed supply package did not include the full range of supplies typically used when performing contrast imaging. One commenter stated that, for echocardiography labs that utilize contrast-enhanced ultrasound, additional items are typically part of the contrast imaging supply package, including 2x2 gauze pads, a stopcock, and tape. Another commenter suggested that a power injector should also be included in the standard contrast imaging supply package. Commenters also noted that CMS provided limited information regarding how the prices were assigned to the supply items, and pointed to discrepancies between the direct PE database files and the prices quoted in the table.

    Response: We appreciate commenters' support for our proposal. We note that the RUC recommendation for the standard contrast imaging supply package also noted that the inputs for CTA and MRA studies would include the standard contrast imaging supply pack in addition to a stop cock (SC050) and additional tubing. While we acknowledge a commenter's suggestion that additional items may be used when echocardiography labs conduct contrast-enhanced ultrasound studies, we do not have information to suggest that these items are used for other imaging studies, such as CT and MRI contrast-enhanced studies. We would welcome more information on whether these items should be included in the newly created standard contrast imaging kit, as well as whether the power injector is used whenever the other inputs in the standard contrast imaging supply package are used, or whether they are used only in certain instances. We note that the reason for the discrepancy in the price for the IV starter kit is that we proposed to update the price at the same time that we proposed to create a new contrast imaging kit. Since we are finalizing the price update for SA019 (kit, IV starter), we are also finalizing a revised price for the new standard contrast imaging package of $7.06. Finally, we disagree with the commenter's suggestion that CMS provided limited information about the pricing for the items included in the kit, as these items are existing inputs in the direct PE database, and the codes associated with these items were listed in the table in the proposed rule. After consideration of comments received, we are finalizing our proposal to create a standard contrast imaging supply pack, with a revised price of $7.06.

  23. Direct PE Inputs for Stereotactic Radiosurgery (SRS) Services (CPT Codes 77372 and 77373)

    In the CY 2014 PFS final rule with comment period (78 FR 74245), we summarized comments received about whether CPT codes 77372 and 77373 would accurately reflect the resources used in furnishing the typical SRS delivery if there were no coding distinction between robotic and non-robotic delivery methods. Until now, SRS services furnished using robotic methods were billed using contractor-priced G-codes G0339 (Image-guided robotic linear accelerator based stereotactic radiosurgery, complete course of therapy in one session or first session of fractionated treatment), and G0340 (Image-guided robotic linear accelerator-based stereotactic radiosurgery, delivery including collimator changes and custom plugging, fractionated treatment, all lesions, per session, second through fifth sessions, maximum five sessions per course of treatment). We indicated that we would consider deleting these codes in future rulemaking.

    Most commenters responded that the CPT codes accurately described both services, and the RUC stated that the direct PE inputs for the CPT codes accurately accounted for the resource costs of the described services. One commenter objected to the deletion of the G-codes but did not include any information to suggest that the CPT codes did not describe the services or that the direct PE inputs for the CPT codes were inaccurate. Based on a review of the comments received, we had no indication that the direct PE inputs included in the CPT codes would not reflect the typical resource inputs involved in furnishing an SRS service. Therefore, in the CY 2014 proposed rule we proposed to recognize only the CPT codes for SRS services, and to delete the G-

    codes used to report robotic delivery of SRS.

    Comment: We received several comments regarding our proposal to delete the SRS G-codes. Some commenters supported our proposal, but most opposed our proposal on the grounds that the direct PE inputs included in the CPT codes do not reflect the typical resource inputs used in furnishing robotic SRS services. Some commenters urged CMS to delay this policy change and continue to contractor price the G-codes until a more appropriate solution can be found.

    Response: After consideration of the comments regarding the appropriate inputs to use in pricing the SRS services, we have concluded that at this time, we lack sufficient information to make a determination about the appropriateness of deleting the G-codes and paying for all SRS/SBRT services using the CPT codes. Therefore, we will not delete the G-codes for 2015, but will instead work with stakeholders to identify an alternate approach and reconsider this issue in future rulemaking.

  24. Inclusion of Capnograph for Pediatric Polysomnography Services

    We proposed to include equipment item EQ358, Sleep capnograph, polysomnography (pediatric), for CPT codes 95782 (Polysomnography; younger than 6 years, sleep staging with

    Page 67568

    4 or more additional parameters of sleep, attended by a technologist) and 95783 (Polysomnography; younger than 6 years, sleep staging with 4 or more additional parameters of sleep, with initiation of continuous positive airway pressure therapy or bi-level ventilation, attended by a technologist). Based upon our understanding that capnography is a required element of sleep studies for patients younger than 6 years, we proposed to allocate this equipment item to 95782 for 602 minutes, and 95783 for 647 minutes. Based on the invoice we received for this equipment item, we proposed to price EQ358 at $4,534.23.

    Comment: We received two comments in support of our proposal to include the capnograph in CPT codes 95782 and 95783.

    Response: We appreciate commenters' support for our proposal. After consideration of comments received, we are finalizing our proposal to include the capnograph in CPT codes 95782 and 95783.

    4. Using OPPS and ASC Rates in Developing PE RVUs

    Accurate and reliable pricing information for both individual items and indirect PEs is critical to establish accurate PE RVUs for PFS services. As we have addressed in previous rulemaking, we have serious concerns regarding the accuracy of some of the information we use in developing PE RVUs. In particular, as discussed in the CY 2014 PFS final rule with comment period, we have several longstanding concerns regarding the accuracy of direct PE inputs, including both items and procedure time assumptions, and prices of individual supplies and equipment (78 FR 74248-74250). In addition to the concerns regarding the inputs used in valuing particular procedures, we also noted that the allocation of indirect PE is based on information collected several years ago (as described above) and will likely need to be updated in the coming years.

    To mitigate the impact of some of these potentially problematic data used in developing values for individual services, in rulemaking for the CY 2014 PFS, 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 and believed OPPS and ASC payment rates would provide an appropriate comparison because these rates are based on relatively more reliable cost information in settings with cost structures that generally would be expected to be higher than in the office setting.

    We received many comments regarding our proposal, the vast majority of which urged us to withdraw the proposal. Some commenters questioned the validity of our assumption that facilities' costs for providing all services are necessarily higher than the costs of physician offices or other nonfacility settings. Other commenters expressed serious concerns with the asymmetrical comparisons between PFS payment amounts and OPPS/

    ASC payment amounts. Finally, many commenters suggested revisions to technical aspects of our proposed policy.

    In considering all the comments, however, we were persuaded that the comparison of OPPS (or ASC) payment amounts to PFS payment amounts for particular procedures is not the most appropriate or effective approach to ensuring that PFS payment rates are based on accurate cost assumptions. Commenters noted several flaws with the approach. First, unlike PFS payments, OPPS and ASC payments for individual services are grouped into rates that reflect the costs of a range of services. Second, commenters suggested that since the ASC rates reflect the OPPS relative weights to determine payment rates under the ASC payment system, and are not based on cost information collected from ASCs, the ASC rates should not be used in the proposed policy. For these and other reasons raised by commenters, we did not propose a similar policy for the CY 2015 PFS. If we consider using OPPS or ASC payment rates in developing PFS PE RVUs in future rulemaking, we would consider all of the comments received regarding the technical application of the previous proposal.

    After thorough consideration of the comments regarding the CY 2014 proposal, we continue to believe that there are various possibilities for leveraging the use of available hospital cost data in the PE RVU methodology to ensure that the relative costs for PFS services are developed using data that is auditable and comprehensively and regularly updated. Although some commenters questioned the premise that the hospital cost data are more accurate than the information used to establish PE RVUs, we continue to believe that the routinely updated, auditable resource cost information submitted contemporaneously by a wide array of providers across the country is a valid reflection of ``relative'' resources and could be useful to supplement the resource cost information developed under our current methodology based upon a typical case that are developed with information from a small number of representative practitioners for a small percentage of codes in any particular year.

    Section 220(a)(1) of the PAMA added a new subparagraph (M) under section 1848(c)(2) of the Act that gives us authority to collect information on resources used to furnish services from eligible professionals (including physicians, non-physician practitioners, PTs, OTs, SLPs and qualified audiologists), and other sources. It also authorizes us to pay eligible professionals for submitting solicited information. We will be exploring ways of collecting better and updated resource data from physician practices, including those that are provider-based, and other non-facility entities paid through the PFS. We believe such efforts will be challenging given the wide variety of practices, and that any effort will likely impose some burden on eligible professionals paid through the PFS regardless of the scope and manner of data collection. Currently, through one of the validation contracts discussed in section II.B. of this final rule with comment period, we have been gathering time data directly from physician practices. Through this project, we have learned much about the challenges for both CMS and the eligible professionals of collecting data directly from practices. Our own experience has shown that is difficult to obtain invoices for supply and equipment items that we can use in pricing direct PE inputs.

    Many specialty societies also have noted the challenges in obtaining recent invoices for medical supplies and equipment (78 FR 74249). Further, PE calculations rely heavily on information from the Physician Practice Expense Information Survey (PPIS) survey, which, as discussed earlier, was conducted in 2007 and 2008. When we implemented the results of the survey, many in the community expressed serious concerns over the accuracy of this or other PE surveys as a way of gathering data on PE inputs from the diversity of providers paid under the PFS.

    In addition to data collection, section 1848(c)(2)(M) of the Act as added by section 220(a) of the PAMA provides authority to develop and use alternative approaches to establish PE relative values, including the use of data from other suppliers and providers of services. We are exploring the best approaches for exercising this authority, including with respect to use of hospital outpatient cost data. We understand that

    Page 67569

    many stakeholders will have concerns regarding the possibility of using hospital outpatient cost data in developing PE RVUs under the PFS, and we want to be sure we are aware of these prior to considering or developing any future proposal relying on those data.

    Therefore, in the CY 2015 PFS proposed rule (79 FR 40333), we sought comment on the possible uses of the Medicare hospital outpatient cost data (not the APC payment amount) in potential revisions of the PFS PE methodology. This could be as a means to validate or, perhaps, in setting the relative resource cost assumptions within the PFS PE methodology. We noted that the resulting PFS payment amounts would not necessarily conform to OPPS payment amounts since OPPS payments are grouped into APCs, while PFS payments would continue to be valued individually and would remain subject to the relativity inherent in establishing PE RVUs, budget neutrality adjustments, and PFS updates. We expressed particular interest in comments that compare such possibilities to other broad-based, auditable, mechanisms for data collection, including any we might consider under the authority provided under section 220(a) of the PAMA. We urged commenters to consider a wide range of options for gathering and using the data, including using the data to validate or set resource assumptions for only a subset of PFS services, or as a base amount to be adjusted by code or specialty-level recommended adjustments, or other potential uses. We appreciate the many thoughtful comments that we received on whether and how to use the OPPS cost data in establishing PE relative values. We will consider these as we continue to think about mechanisms to improve the accuracy of PE values.

    In addition to soliciting comments as noted above, in the CY 2015 proposed rule we stated that we continue to seek a better understanding regarding the growing trend toward hospital acquisition of physicians' offices and how the subsequent treatment of those locations as off-

    campus provider-based outpatient departments affects payments under PFS and beneficiary cost-sharing. MedPAC continues to question the appropriateness of increased Medicare payment and beneficiary cost-

    sharing when physicians' offices become hospital outpatient departments, and to recommend that Medicare pay selected hospital outpatient services at PFS rates (MedPAC March 2012 and June 2013 Report to Congress). We noted that we also remain concerned about the validity of the resource data as more physician practices become provider-based. Our survey data reflects the PE costs for particular PFS specialties, including a proportion of practices that may have become provider-based since the survey was conducted. Additionally, as the proportion of provider-based offices varies among physician specialties, so do the relative accuracy of the PE survey data. Our current PE methodology primarily distinguishes between the resources involved in furnishing services in two sites of service: The non-

    facility setting and the facility setting. In principle, when services are furnished in the non-facility setting, the costs associated with furnishing services include all direct and indirect PEs associated with the work and the PE of the service. In contrast, when services are furnished in the facility setting, some costs that would be PEs in the office setting are incurred by the facility. Medicare makes a separate payment to the facility to account for some portion of these costs, and we adjust PEs accordingly under the PFS. As more physician practices become hospital-based, it is difficult to know which PE costs typically are actually incurred by the physician, which are incurred by the hospital, and whether our bifurcated site-of service differential adequately accounts for the typical resource costs given these relationships. We also have discussed this issue as it relates to accurate valuation of visits within the postoperative period of 10- and 90-day global codes in section II.B.4 of this final rule with comment period.

    To understand how this trend is affecting Medicare, including the accuracy of payments made through the PFS, we need to develop data to assess the extent to which this shift toward hospital-based physician practices is occurring. To that end, during CY 2014 rulemaking we sought comment regarding the best method for collecting information that would allow us to analyze the frequency, type, and payment for services furnished in off-campus provider-based hospital departments (78 FR 74427). We received many thoughtful comments. However, the commenters did not present a consensus opinion regarding the options we presented in last year's rule. Based on our analysis of the comments, we stated that we believed the most efficient and equitable means of gathering this important information across two different payment systems would be to create a HCPCS modifier to be reported with every code for physicians' and hospital services furnished in an off-campus provider-based department of a hospital.

    We proposed that the modifier would be reported on both the CMS-

    1500 claim form for physicians' services and the UB-04 (CMS form 1450) for hospital outpatient claims. (We note that the requirements for a determination that a facility or an organization has provider-based status are specified in Sec. 413.65, and we define a hospital campus to be the physical area immediately adjacent to the provider's main buildings, other areas and structures that are not strictly contiguous to the main buildings but are located within 250 yards of the main buildings, and any other areas determined on an individual case basis, by the CMS regional office.)

    Therefore, we proposed to collect this information on the type and frequency of services furnished in off-campus provider-based departments in accordance with our authority under section 1848(c)(2)(M) of the Act (as added by section 220(a) of the PAMA) beginning January 1, 2015. The collection of this information would allow us to begin to assess the accuracy of the PE data, including both the service-level direct PE inputs and the specialty-level indirect PE information that we currently use to value PFS services. Furthermore, this information would be critical in order to develop proposed improvements to our PE data or methodology that would appropriately account for the different resource costs among traditional office, facility, and off-campus provider-based settings. We also sought additional comment on whether a code modifier is the best mechanism for collecting this service-level information.

    Comment: Many commenters agreed on the need to collect information on the frequency, type, and payment of services furnished in off-campus provider-based departments of hospitals, however, several commenters expressed concern that the HCPCS modifier would create additional administrative burden for providers. Many of these commenters stated that the new modifier would require significant changes to hospitals' billing systems, including a separate charge master for outpatient off-

    campus PBDs and training for staff on how to use the new modifier. Several commenters thought that education and training would be required for physician offices to attach a modifier to services furnished in an off-campus provider-based department. These same commenters suggested that a new place of service (POS) code would be more appropriate for physician billing. Several commenters suggested that CMS

    Page 67570

    should re-propose a detailed data collection methodology, test it with providers, make adjustments, and allow additional time for implementation.

    Response: While we understand commenters' concerns about the additional administrative burden of reporting a new HCPCS modifier, we have weighed the burden of reporting the modifier for each service against the benefit of having data that will allow us to obtain and assess accurate information on the type and frequency of outpatient hospital services furnished in off-campus provider-based departments, and we do not believe that the modifier is excessively burdensome for providers to report. When billing for hospital services, providers must know where services are furnished in order to accurately complete value code 78 of an outpatient claim or item 32 for service location on the practitioner claim. However, as discussed later in this section, we agree that a POS code on the professional claim allows for the same type of data collection as a modifier and would be less burdensome than the modifier for practitioners. We discuss the timeframe for implementation later in this section.

    Comment: Some commenters who were concerned about the administrative burden of the new HCPCS modifier suggested several alternative methods for CMS to collect data on services furnished in off-campus provider-based departments. Several of these commenters recommended that CMS consider establishing of a new POS code for professional claims, or for both professional and hospital claims, because they believed this approach would be less administratively burdensome than attaching a modifier to each service reported on the claim that was furnished in an off-campus provider-based department. Some commenters preferred identifying services furnished in provider-

    based departments on the Medicare cost report (CMS-2552-10). Some commenters suggested using provider numbers and addresses to identify off-campus PBDs, or changing the provider enrollment process to be able to track this data. Yet other commenters suggested creating a new bill type to track off-campus PBD services.

    Commenters generally recommended that CMS choose the least administratively burdensome approach that would ensure accurate data collection, but did not necessarily agree on what approach would optimally achieve that result. Some commenters believed that a HCPCS modifier would more clearly identify specific services furnished at off-campus PBDs, and would provide better information about the type and level of care furnished. Some commenters believed that a HCPCS modifier would be the least administratively burdensome approach because hospitals and physicians already report a number of claims-

    based modifiers. However, other commenters stated that additional modifiers would increase administrative burden because this approach would increase the modifiers that would need to be considered when billing.

    Response: With respect to creating a new POS code to obtain data on services furnished in off-campus PBDs of a hospital, we note that POS codes are only reported on professional claims and are not included on institutional claims. Therefore, a POS code could not be easily implemented for hospital claims. However, POS codes are already required to be reported on every professional claim, and POS 22 is currently used when physicians' services are furnished in an outpatient hospital department. (More information on existing POS codes is available on the CMS Web site at http://www.cms.gov/Medicare/Coding/place-of-service-codes/Place_of_Service_Code_Set.html).

    Though we considered proposing a new POS code for professional claims to collect data on services furnished in the off-campus hospital setting, we note that previous GAO and OIG reports (October 2004 A-05-

    04-0025, January 2005 A-06-04-00046, July 2010 A-01-09-00503, September 2011 A-01-10-00516) have noted frequent inaccuracies in the reporting of POS codes. Additionally, at the time the proposed rule was developed, we had concerns that using a POS code to report this information might not give us the reliable data we are looking to collect, especially if such data were to be cross-walked with hospital claims for the same service, since the hospital claim would have a modifier, not a POS code. However, we have been persuaded by public comments suggesting that use of a POS code on professional claims would be less administratively burdensome than use of a modifier, and would be more familiar to those involved in practitioner billing. Specifically, since a POS code is already required on every professional claim, we believe that creating a new POS code to distinguish outpatient hospital services that are furnished on the hospital campus versus in an off-campus provider-based department would require less staff training and education than would the use of a modifier on the professional claim. Additionally, professional claims only have space for four modifiers; while a very small percentage of professional claims have four modifiers, required use of an additional modifier for every professional claim could lead to more occurrences where there would not be space for all applicable payment modifiers for a specific service. Unlike institutional claims, we note that a new professional claim is required whenever the place of service changes. That is, even if the same practitioner treats the same patient on the same day in the office and the hospital, the services furnished in the office setting must be submitted on one claim with POS 11 (Office), while those furnished in the outpatient hospital department would be submitted on a separate claim with POS 22 (Outpatient Hospital). Likewise, if a new POS code were to be created for off-campus outpatient provider-based hospital department, a separate claim for services furnished in that setting would be required relative to a claim for outpatient services furnished on the hospital's main campus by the same practitioner to the same patient on the same day. Based on public comments and after further consultation with Medicare billing experts, we believe that use of the POS code on professional claims would be no less accurate than use of a modifier on professional claims in identifying services furnished in off-campus PBDs. In addition, we believe that the POS code would be less administratively burdensome for practitioners billing using the professional claim since a POS code is already required for every professional claim.

    With respect to adding new fields to existing claim forms or creating a new bill type, we do not believe that this data collection warrants these measures. We believe that those changes would create greater administrative burden than the proposed HCPCS modifier and POS codes, especially since providers are already accustomed to using modifiers and POS codes. Revisions to the claim form to add new fields or an additional bill type would create significant administrative burden to revise claims processing systems and educate providers that is not necessary given the availability of a modifier and POS codes. Though providers may not be familiar with this new modifier or any new POS code; since these types of codes already exist generally for hospital and professional claims, providers and suppliers should already have an understanding of these types of codes and how to apply them. Finally, we do not believe that expansions to the claim form or use of a new bill type

    Page 67571

    would provide us with detailed information on exactly which services were furnished in an off-campus PBD versus those furnished on the main campus when those services are furnished on the same day.

    We also do not believe that we could accurately determine which services are furnished at off-campus provider-base departments (PBDs) using currently available NPI and facility address data. Hospitals are required to report the nine-digit ZIP code indicating where a service was furnished for purposes of paying properly for physician and anesthesia services paid off the PFS when that ZIP code differs from the master address for the hospital on file in CMS claims systems in value code 78 (pub 100-04, transmittal 1681, February 13, 2009). However, the billing ZIP code for the hospital main campus could be broad enough to incorporate on and off-campus provider-based departments. Further, a ZIP code reported in value code 78 does not allow CMS to distinguish between services furnished in different locations on the same date. Therefore, we do not believe that a comparison of the ZIP code captured in value code 78 and the main campus ZIP code is sufficiently precise.

    Finally, while we considered the suggestion that CMS use currently reported Medicare hospital cost report (CMS-2552-10) data to identify services furnished at off-campus PBDs, we note that though aggregate data on services furnished in different settings must be reported through the appropriate cost center, we would not be able to obtain the service-specific level of detail that we would be able to obtain from claims data.

    We will take under consideration the suggestion that CMS create a way for hospitals to report their acquisition of physician offices as off-campus PBDs through the enrollment process, although this information, as currently reported, would not allow us to know exactly which services are furnished in off-campus provider based departments and which services are furnished on the hospital's main campus when a hospital provides both on the same day.

    Comment: Commenters noted that the proposed modifier would not allow CMS to know the precise location of the off-campus provider-based department for billed services or when services are furnished at different off-campus provider-based locations in the same day.

    Response: We agree that neither the proposed modifier nor a POS code provides details on the specific provider-based location for each furnished service. However, we believe that collecting information on the type and frequency of services furnished at all off-campus locations will assist CMS in better understanding the distribution of services between on and off-campus locations.

    Comment: MedPAC believed there may be some value in collecting data on services furnished in off-campus provider-based departments to validate the accuracy of site-of-service reporting when the physician's office is off-campus but bills as an outpatient department. MedPAC indicated that any data collection effort should not prevent the development of policies to align payment rates across settings. MedPAC encouraged CMS to seek legislative authority to set equal payment rates across settings for evaluation and management office visits and other select services.

    Response: We thank MedPAC for its support of our data collection efforts to learn more about the frequency and types of services that are being furnished in off-campus PBDs.

    Comment: Many commenters suggested that providers would not be able to accurately apply the new modifier by the January 1, 2015 implementation timeline and recommended a one-year delay before providers would be required to apply the modifier to services furnished at off-campus PBDs. Some commenters requested only a six-month delay in implementation. Commenters indicated that significant revisions to internal billing processes would require additional time to implement.

    Response: Though we believe that the January 1st effective date that applies to most policies adopted in the final rules with comment period for both the PFS and the OPPS would provide sufficient lead time, we understand commenters' concerns with the proposed timeline for implementation given that the new reporting requirements may require changes to billing systems as well as education and training for staff. With respect to the POS code for professional claims, we will request two new POS codes to replace POS code 22 (Hospital Outpatient) through the POS Workgroup and expect that it will take some time for these new codes to be established. Once the revised POS codes are ready and integrated into CMS claims systems, practitioners would be required to use them, as applicable. More information on the availability of the new POS codes will be forthcoming in subregulatory guidance, but we do not expect the new codes to be available prior to July 1, 2015. There will be no voluntary reporting period of the POS codes for applicable professional claims because each professional claim requires a POS code in order to be accepted by Medicare. However, we do not view this to be problematic because we intend to give prior notice on the POS coding changes and, as many public commenters noted, because practitioners are already accustomed to using a POS on every claim they submit.

    We also are finalizing our proposal to create a HCPCs modifier for hospital services furnished in an off-campus PBD setting; but we are adopting a voluntary reporting period for the new HCPCS modifier for one year. That is, reporting the new HCPCS modifier for services furnished at an off-campus PBD will not be mandatory until January 1, 2016, in order to allow providers time to make systems changes, test these changes, and train staff on use of the new modifier before reporting is required. We welcome early reporting of the modifier and believe a full year of preparation should provide hospitals with sufficient time to modify their systems for accurate reporting.

    Comment: Many commenters expressed concern that this data collection would eventually lead to equalizing payment for similar services furnished in the non-facility setting and the off-campus PBD setting. Several commenters noted that the trend of hospitals acquiring physician practices is due to efforts to better integrate care delivery, and suggested that CMS weigh the benefits of care integration when deciding payment changes. Some commenters suggested that CMS should use the data to equalize payment for similar services between these two settings. These commenters suggest that there is little difference in costs and care between the two settings that would warrant the difference in payment. Several of these commenters highlighted beneficiary cost sharing as one reason for site-neutral payment, noting that the total payment amount for hospital outpatient services is generally higher than the total payment amount for those same services when furnished in a physician's office.

    Response: We appreciate the comments received. At this time, we are only finalizing a data collection in this final rule with comment period. We did not propose, and therefore, are not finalizing any adjustment to payments furnished in the off-campus PBD setting.

    Comment: Several commenters noted that the CMS proposal would not provide additional information on how a physician practice billed prior to becoming an off-campus PBD, which would be important for analyzing the impact of this trend.

    Page 67572

    Response: We agree that, in analyzing the impact of this trend, it is important to understand physician billing patterns that were in place prior to becoming an off-campus PBD, and we will continue to evaluate ways to analyze claims data to gather this information. We believe that collecting data using the additional modifier and POS code as finalized in this rule will be an important tool in furthering this analysis.

    Comment: Some commenters suggested that the term ``off-campus'' needs to be better defined. Commenters asked how billing would occur for hospitals with multiple campuses since the CMS definition of campus references main buildings and does not include remote locations. One commenter also asked whether the modifier is intended to cover services furnished in free-standing emergency departments.

    Response: For purposes of the modifier and the POS codes we are finalizing in this final rule with comment period, we define a ``campus'' using the definition at Sec. 413.65(a)(2) to be the physical area immediately adjacent to the provider's main buildings, other areas and structures that are not strictly contiguous to the main buildings but are located within 250 yards of the main buildings, and any other areas determined on an individual case basis, by the CMS regional office, to be part of the provider's campus. We agree with commenters that our intent is to capture data on outpatient services furnished off of the hospital's main campus and off of any of the hospital's other campuses. The term ``remote location of a hospital'' is defined in our regulations at section 413.65(a)(2). Under the regulation, a ``remote location'' includes a hospital campus other than the main hospital campus. Specifically, a remote location is ``a facility or an organization that is either created by, or acquired by, a hospital that is a main provider for the purposes of furnishing inpatient hospital services under the name, ownership, and financial and administrative control of the main provider . . . .'' Therefore, we agree with the commenters that the new HCPCS modifier and the POS code for off-campus PBDs should not be reported for services furnished in remote locations of a hospital. The term ``remote location'' does not include ``satellite'' locations of a hospital. However, since a satellite facility is one that provides inpatient services in a building also used by another hospital, or in one or more entire buildings located on the same campus as buildings used by another hospital, the new HCPCS modifier and the POS code for off-campus hospital PBDs should not be reported for services furnished in satellite facilities. Satellite facilities are described in our regulations at Sec. 412.22(h). Accordingly, reporting of the modifier and the POS code that identifies an off-campus hospital PBD would be required for outpatient services furnished in PBDs that are located beyond 250 yards from the main campus of the hospital, excluding services furnished in a remote location or satellite facility of the hospital.

    We also appreciate the comment on emergency departments. We do not intend for hospitals to report the new modifier for services furnished in emergency departments. We note that there is already a POS code for the emergency department, POS 23 (emergency room-hospital), and this would continue to be used on professional claims for services furnished in emergency departments. That is, the new POS code for off-campus hospital PBDs that will be created for purposes of this data collection would not apply to emergency department services. Hospitals and practitioners that have questions about which departments are considered to be ``off-campus PBDs'' should review additional guidance that CMS releases on this policy and work with the appropriate CMS regional office if individual, specific questions remain.

    Comment: Several commenters asked for clarification on when to report the modifier for services furnished both on and off-campus on the same day. Commenters provided several scenarios of visits and diagnostic services furnished on the same day.

    Response: The location where the service is actually furnished would dictate the use of the modifier and the POS codes, regardless of where the order for services is initiated. We expect the modifier and the POS code for off-campus PBDs to be reported in locations in which the hospital expends resources to furnish the service in an off-campus PBD setting. For example, hospitals would not report the modifier for a diagnostic test that is ordered by a practitioner who is located in an off-campus PBD when the service is actually furnished on the main campus of the hospital. This issue does not impact use of the POS codes since practitioners submit a different claim for each POS where they furnish services for a specific beneficiary.

    Comment: A few commenters asked for clarification on whether their entity constitutes a provider-based department.

    Response: Provider-based departments are departments of the hospital that meet the criteria in Sec. 413.65.

    Comment: A commenter recommended that CMS publish the data it acquires through adoption of this modifier.

    Response: Data collected through the new HCPCS modifier would be part of the Medicare Limited Data Set and would be available to the public for purchase along with the rest of the Limited Data Set. Similarly, professional claims data with revised POS coding would be available as a standard analytic file for purchase.

    In summary, after consideration of the comments received, we are finalizing our proposal with modifications. For professional claims, instead of finalizing a HCPCS modifier, in response to comments, we will be deleting current POS code 22 (outpatient hospital department) and establishing two new POS codes--one to identify outpatient services furnished in on-campus, remote or satellite locations of a hospital, and another to identify services furnished in an off-campus hospital PBD setting that is not a remote location of a hospital, a satellite location of a hospital or a hospital emergency department. We will maintain the separate POS code 23 (emergency room-hospital) to identify services furnished in an emergency department of the hospital. These new POS codes will be required to be reported as soon as they become available, however advance notice of the availability of these codes will be shared publicly as soon as practicable.

    For hospital claims, we are creating a HCPCS modifier that is to be reported with every code for outpatient hospital services furnished in an off-campus PBD of a hospital. This code will not be required to be reported for remote locations of a hospital defined at Sec. 412.65, satellite facilities of a hospital defined at Sec. 412.22(h) or for services furnished in an emergency department. This 2-digit modifier will be added to the HCPCS annual file as of January 1, 2015, with the label ``PO,'' the short descriptor ``Serv/proc off-campus pbd,'' and the long descriptor ``Services, procedures and/or surgeries furnished at off-campus provider-based outpatient departments.'' Reporting of this new modifier will be voluntary for 1 year (CY 2015), with reporting required beginning on January 1, 2016. Additional instruction and provider education will be forthcoming in subregulatory guidance.

    Page 67573

    1. Potentially Misvalued Services Under the Physician Fee Schedule

    1. Valuing Services Under the PFS

    Section 1848(c) of the Act requires the Secretary to determine relative values for physicians' services based on three components: Work, PE, and malpractice. Section 1848(c)(1)(A) of the Act defines the work component to mean, ``the portion of the resources used in furnishing the service that reflects physician time and intensity in furnishing the service.'' In addition, section 1848(c)(2)(C)(i) of the Act specifies that ``the Secretary shall determine a number of work relative value units (RVUs) for the service based on the relative resources incorporating physician time and intensity required in furnishing the service.''

    Section 1848(c)(1)(B) of the Act defines the PE component as ``the portion of the resources used in furnishing the service that reflects the general categories of expenses (such as office rent and wages of personnel, but excluding malpractice expenses) comprising practice expenses.'' Section 1848(c)(2)(C)(ii) of the Act requires that PE RVUs be determined based upon the relative PE resources involved in furnishing the service. (See section II.A. of this final rule with comment period for more detail on the PE component.)

    Section 1848(c)(1)(C) of the Act defines the MP component as ``the portion of the resources used in furnishing the service that reflects malpractice expenses in furnishing the service.'' Section 1848(c)(2)(C)(iii) of the Act specifies that MP expense RVUs shall be determined based on the relative MP expense resources involved in furnishing the service. (See section II.C. of this final rule with comment period for more detail on the MP component.)

    2. Identifying, Reviewing, and Validating the RVUs of Potentially Misvalued Services

  25. 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) of 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 final rule with comment period, 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 as authorized by the law. We may also consider analyses of work time, work RVUs, or direct 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 Initiative (PQRI) 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 taking into account the results of consultations with organizations representing physicians. In accordance with section 1848(c) of the Act, we determine and make appropriate adjustments to the RVUs.

    In its March 2006 Report to the Congress, MedPAC discussed the importance of appropriately valuing physicians' services, noting that ``misvalued services can distort the price signals for physicians' services as well as for other health care services that physicians order, such as hospital services.'' In that same report MedPAC postulated that physicians' services under the PFS can become misvalued over time. MedPAC stated, ``When a new service is added to the physician fee schedule, it may be assigned a relatively high value because of the time, technical skill, and psychological stress that are often required to furnish that service. Over time, the work required for certain services would be expected to decline as physicians become more familiar with the service and more efficient in furnishing it.'' We believe services can also become overvalued when PE declines. This can happen when the costs of equipment and supplies fall, or when equipment is used more frequently than is estimated in the PE methodology, reducing its cost per use. Likewise, services can become undervalued when physician work increases or PE rises.

    As MedPAC noted in its March 2009 Report to Congress, in the intervening years since MedPAC made its initial recommendations, ``CMS and the RUC have taken several steps to improve the review process.'' Also, since that time the Congress added section 1848(c)(2)(K)(ii) to the Act, which augments our efforts. It directs the Secretary to specifically examine, as determined appropriate, potentially misvalued services in the following seven categories:

    Codes and families of codes for which there has been the fastest growth;

    Codes and families of codes that have experienced substantial changes in PEs;

    Codes that are recently established for new technologies or services;

    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 which have not been subject to review since the implementation of the RBRVS (the so-called `Harvard-valued codes'); and

    Other codes determined to be appropriate by the Secretary.

    Section 220(c) of the Protecting Access to Medicare Act of 2014 (PAMA) further expanded the categories of codes that the Secretary is directed to examine by adding nine additional categories. These are:

    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;

    Page 67574

    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 PE RVUs; and

    Codes with high cost supplies.

    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 of the Act 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 physician fee schedule.

  26. 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 as authorized by statute over the coming 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 1,250 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 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 Harvard-

    valued services with annual allowed charges that total at least $10,000,000 as potentially misvalued. 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 that have 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. For CY 2014, we also considered a proposal to limit PFS payments for services furnished in a nonfacility setting when the nonfacility PFS payment for a given service exceeds the combined Medicare Part B payment for the same service when it is furnished in a facility (separate payments being made to the practitioner under the PFS and to the facility under the OPPS). Based upon extensive public comment, we did not finalize this proposal. We address our current consideration of the potential use of OPPS data in establishing RVUs for PFS services, as well as comments received, in section II.B. of this final rule with comment period.

  27. 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 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. We provided a summary of the comments along with our responses in the CY 2011 PFS final rule with comment period (75 FR 73217) and the CY 2012 PFS final rule with comment period (76 FR 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. These data will be used to develop time estimates. The Urban Institute will use 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

    Page 67575

    range of specialties to review the new time data and their potential implications for work and the ratio of work to time. The 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 available on the CMS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/RVUs-Validation-UrbanInterimReport.pdf. Collection of time data under this project has just begun. 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 will use a representative set of CMS-provided codes to test the model. RAND consulted with a technical expert panel on model design issues and the test results. We anticipate a report from this project by the end of the year and will make the report available on the CMS Web site.

    Descriptions of both projects are available on the CMS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/RVUs-Validation-Model.pdf.

    We acknowledge comments received regarding the Urban Institute and RAND projects, but note that we did not solicit comments on these projects because we made no proposals related to them. Any changes to payment policies under the PFS that we might make after considering these reports would be issued in a proposed rule and subjected to public comment before they would be finalized and implemented.

    3. CY 2015 Identification and Review of Potentially Misvalued Services

  28. 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 include 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, VA NSQIP, STS National Database, and the 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 to the CY 2014 final rule with comment period, we received nominations and supporting documentation for four codes to be considered as potentially misvalued codes. Although we evaluated the supporting documentation for two of the nominated codes to ascertain whether the submitted information demonstrated that the code should be proposed as potentially misvalued, we did not identify the other two codes until after the publication of the proposed rule. We apologize for this oversight and will address the nomination of CPT codes 92227 and 92228 in the proposed rule for CY 2016.

    We proposed CPT code 41530 (submucosal ablation of the tongue base, radiofrequency, 1 or more sites, per session) as potentially misvalued based on public nomination due to a significant decrease in two of the direct PE inputs.

    Comment: The commenter that nominated this code as potentially misvalued thanked CMS for proposing this code as potentially misvalued, but indicated that the RUC had made recommendations for this code for CY 2015 and further review was no longer necessary. Another commenter suggested that this code should be removed from the list of potentially misvalued codes since it saves Medicare millions of dollars per year.

    Response: The RUC only provided us with recommendations for PE inputs for CPT code 41530. Under our usual process, we value work and PE at the same time and would expect to receive RUC recommendations on both before we revalue this service. We disagree with the commenter's statement that codes that may save money for the Medicare program should not be considered as potentially misvalued. Our aim, consistent with our statutory directive, is to value all services appropriately under the PFS to reflect the relative resources involved in furnishing them. After consideration of public comments, we are finalizing CPT code 41530 as potentially misvalued.

    We did not propose CPT code 99174 (instrument-based ocular screening (for example, photoscreening, automated-refraction), bilateral) as potentially misvalued, because it is a non-covered service, and we only consider nominations of active codes that are covered by Medicare at the time of the nomination (see 76 FR 73059).

    Comment: Commenters did not disagree with CMS not proposing this code as potentially misvalued, but did raise a variety of comments about the code that were unrelated to our proposal.

    Response: We continue to believe that our policy to limit the designation of potentially misvalued to those codes that are covered by Medicare is appropriate, so that we focus our limited resources on those services that have an impact on the Medicare program and its beneficiaries. Therefore, we are not including CPT code 99174 on

    Page 67576

    our final list of potentially misvalued codes for CY 2015.

  29. Potentially Misvalued Codes

    (1) Review of High Expenditure Services Across Specialties With Medicare Allowed Charges of $10,000,000 or More

    We proposed 68 codes listed in Table 11 as potentially misvalued codes under the newly established statutory category, ``codes that account for the majority of spending under the physician fee schedule.'' To develop this list, we identified the top 20 codes by specialty (using the specialties used in Table 11) in terms of allowed charges. We excluded those codes that we have reviewed since CY 2009, those codes with fewer than $10 million in allowed charges, and E/M services. E/M services were excluded for the same reason that we excluded them in a similar review for CY 2012. The reason was explained in the CY 2012 final rule with comment period (76 FR 73062 through 73065).

    We stated that we believed that a review of the codes in Table 11 is warranted to assess changes in physician work and to update direct PE inputs since these codes have not been reviewed since CY 2009 or earlier. Furthermore, since these codes have significant impact on PFS payment at the specialty level, a review of the relativity of the codes is essential to ensure that the work and PE RVUs are appropriately relative within the specialty and across specialties, as discussed previously. For these reasons, we proposed the codes listed in Table 11 as potentially misvalued.

    Table 11--Potentially Misvalued Codes Identified Through the High

    Expenditure by Specialty Screen

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

    HCPCS Short descriptor

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

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

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

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

    11750........................... Removal of nail bed.

    14060........................... Tis trnfr e/n/e/l 10 sq cm/.

    17110........................... Destruct b9 lesion 1-14.

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

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

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

    36475........................... Endovenous rf 1st vein.

    36478........................... Endovenous laser 1st vein.

    36870........................... Percut thrombect av fistula.

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

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

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

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

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

    65855........................... Laser surgery of eye.

    66821........................... After cataract laser surgery.

    67228........................... Treatment of retinal lesion.

    68761........................... Close tear duct opening.

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

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

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

    73560........................... X-ray exam of knee 1 or 2.

    73562........................... X-ray exam of knee 3.

    73564........................... X-ray exam knee 4 or more.

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

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

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

    76700........................... Us exam abdom complete.

    76770........................... Us exam abdo back wall comp.

    76775........................... Us exam abdo back wall lim.

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

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

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

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

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

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

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

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

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

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

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

    93978........................... Vascular study.

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

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

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

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

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

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

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

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

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

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

    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.

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

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

    Comment: Many commenters disagreed with the high expenditure screen in principle, stating that the frequency with which a service is furnished (and therefore the total expenditures) is not an indication that the service is misvalued. Specifically, commenters explained that many of the services are highly utilized because of the nature of the Medicare beneficiary population, and not because there is abuse or overutilization. Commenters asserted that the current misvalued code screens can produce a redundant list of potentially misvalued codes while failing to identify codes that are being incorrectly reported. Another commenter urged CMS to work with the RUC to ensure that the code lists identified by the misvalued code screens are accurate. A commenter asked CMS to provide justification for including codes with charges greater than $10 million on the potentially misvalued codes list. Some commenters urged us to reconsider including particular families of codes that were reviewed prior to 2009; others asked that CMS exclude all codes that have been reviewed in the last 10 years; and still others requested that we exclude codes that were bundled several years ago. A commenter stated that the emphasis on codes with spending of more than $10 million demonstrates an agenda to cut spending rather than to ensure appropriate payment, and expressed concern that CMS was simply nominating high value services. Commenters recommended that CMS not finalize its proposed list of potentially misvalued codes, and instead develop a more targeted list of codes that are likely to be misvalued (not just potentially misvalued). Commenters wanted CMS to exempt codes when there have not been fundamental changes in the way the services are furnished or there is no indication that their values are inaccurate, so that specialty societies do not have to go through the work of reviewing them.

    Several commenters questioned the statutory authority for CMS's proposal. One commenter questioned CMS's authority under the relevant statute to select potentially misvalued codes by specialty. The commenter stated that identifying the top 20 codes by specialty in terms of allowed charges does not appear to align with a direct reading of the relevant statutory authority, which allows CMS to identify codes that account for the majority of spending under the PFS, but does not provide for the identification of codes by specialty. The commenter said that a more direct interpretation of the statutory authority would be to select codes based on allowed charges irrespective of specialty, and then to narrow the universe of codes based upon the top codes in terms of allowed charges. Another commenter believed the proposed screen did not comport with the statutory selection criteria because the majority or near majority of spending under the PFS is for evaluation and management (E/M) codes, which CMS excluded from review. The commenter said that if CMS believes that E/M services should not be reviewed--a position the commenter said they would certainly understand--then such a determination is sufficient to meet the statutory mandate to review codes accounting for the majority of PFS spending, and it would then be

    Page 67577

    appropriate for CMS and the RUC to focus efforts on other categories of potentially misvalued codes. The commenter urged CMS at the very least to develop a more targeted list of potentially misvalued services in the category of codes accounting for the majority of PFS spending, and to include codes that are likely to be misvalued, not just potentially misvalued.

    Response: Potentially misvalued code screens are intended to identify codes that are possibly misvalued. By definition, these screens do not assert that codes are certainly or even likely misvalued. As we discussed in the CY 2012 PFS final rule with comment period (76 FR 73056), the screens serve to focus our limited resources on categories of codes where there is a high risk of significant payment distortions. One goal is to avoid perpetuating payment for the services at a rate that does not appropriately reflect the relative resources involved in furnishing the service. In implementing this statutory provision, we consider whether the codes meeting the screening criteria have a significant impact on payment for all PFS services due to the budget neutral nature of the PFS. That is, if codes meeting the screening criteria are indeed misvalued, they would be inappropriately impacting the relative values of all PFS services. Addressing included codes therefore indirectly addresses other codes that do not meet the screening criteria but are themselves misvalued because high expenditure codes are misvalued. We agree with the commenters that high program expenditures and high utilization have varying causes and do not necessarily reflect misvalued codes. However, we continue to believe that the high expenditure screen is nevertheless an appropriate means of focusing our reviews, ensuring appropriate relativity among PFS services, and identifying services that are either over or undervalued. The high expenditure screen is likely to identify misvalued codes, both directly and indirectly.

    Regarding screening for codes by specialty, as we discussed above, the included codes have significant impact on PFS payment at the specialty level, therefore a review of the relativity of the codes is essential to ensure that the work and PE RVUs are appropriately relative within the specialty and across specialties. We mentioned in the CY 2012 final rule with comment period how stakeholders have noted that many of the services previously identified under the potentially misvalued codes initiative were concentrated in certain specialties. To develop a robust and representative list of codes for review, we examine the highest PFS expenditure services by specialty and we identify those codes that have not been recently reviewed (76 FR 73060).

    Although we understand commenters' concerns that the screens can produce redundant results, we note that we exempted codes that have been reviewed since 2009 for this very reason. We believe that the practice of medicine can change significantly over a 10-year period, and disagree with commenters' suggestions that no changes would occur over a 10-year period that would significantly affect a procedure's valuation.

    Regarding the exclusion of E/M services, we refer the commenters to the extensive discussion in the CY 2012 PFS final rule with comment period (76 FR 73060 through 73065). It is true that E/M services account for significant volume under the PFS, but there are significant issues with reviewing these codes as discussed in the CY 2012 final rule with comment period, and as a result we did not propose to include these codes as potentially misvalued.

    Comment: Some commenters suggested other screens that could be used to identify misvalued codes. In addition, even though our proposal only relates to identifying potentially misvalued codes, some commenters commented on our mechanisms for re-valuing misvalued codes.

    Response: The only screen for which we made a proposal and sought comments was the high expenditure screen. However, we will consider the suggestions for other screens as we develop proposals in future years. Similarly, our proposal only related to identifying potentially misvalued codes and not how to re-value them if they were finalized as potentially misvalued.

    Comment: Several commenters requested that CMS postpone the review of potentially misvalued codes until the revised process we proposed for reviewing new, revised, and potentially misvalued codes is in place.

    Response: Although we believe that the revised process for reviewing new, revised, and potentially misvalued codes will improve the transparency of the PFS code review process, we do not believe it is appropriate to postpone the review of all potentially misvalued codes until the new process is implemented. We note that the codes identified in this rule as potentially misvalued would be revalued under the new process, which will be phased in starting for CY 2016 and will apply for all codes revalued for CY 2017.

    Comment: Commenters raised several codes that they believed should not be included in the high expenditure screen for a variety of reasons, for example if the code is related to other codes that were recently reviewed and the utilization for the identified service is expected to change significantly as a result of coding changes in the family. Commenters also suggested that codes that have been referred to the CPT Editorial Panel should be excluded from the potentially misvalued codes list.

    Response: We acknowledge commenters' suggestion that we exclude particular codes from the screen, but since we are not finalizing a particular list of codes for this screen in this final rule we are not addressing these at this time. We note that we do not agree with commenters that codes that have been referred to CPT by the RUC should be excluded from the potentially misvalued list; rather, we believe that only when these codes are either deleted or revised, and/or we receive new RUC recommendations for re-valuing these codes, would it be appropriate to remove these services from the list.

    Comment: A commenter suggested that CMS's high expenditure screen may not account for the fact that many radiology codes have already gone through numerous five-year reviews; have well-established RVUs that are included on the RUC's multispecialty point of comparison (MPC) list; have been included in new, bundled codes; or have PE RVUs that were affected by changes in clinical labor times or equipment utilization assumption changes. The commenter also suggested that the screens do not account for the value that patients receive in terms of better, timelier diagnoses and avoidance of invasive procedures.

    Response: We acknowledge that certain types of procedures have been identified through multiple screens; however, we continue to believe that it is appropriate to include most codes that are identified via these screens and not to exclude codes simply because many other procedures furnished by that specialty have already been reviewed. We further note that the presence of codes on the MPC list makes the case for their review more compelling, given their importance in ensuring overall relativity throughout the PFS. With respect to changes in PE RVUs, we note that cross-cutting policies that affect large numbers of codes are aimed at ensuring overall relativity but do not address the inputs associated with each procedure affected by the change. Finally, a code's status as potentially misvalued does not imply

    Page 67578

    that the service itself is not of inherent value; rather, that its valuation may be inaccurate in either direction.

    After considering the comments received, as well as the other proposals we are finalizing, we believe it is appropriate to finalize the high expenditure screen as a tool to identify potentially misvalued codes. However, given the resources required over the next several years to revalue the services with global periods, we believe it is best to concentrate our efforts on these valuations. Therefore, we are not finalizing the codes identified through the high expenditure screen as potentially misvalued at this time. Also, we are not responding to comments at this time regarding whether particular codes should or should not be included in the high expenditure code screen and identified as potentially misvalued codes. We will re-run the high expenditure screen at a future date, and will propose at that time the specific set of codes to be reviewed that meet the high expenditure criteria.

    (2) Epidural Injection and Fluoroscopic Guidance--CPT Codes 62310, 62311, 62318, 62319, 77001, 77002 and 77003

    For CY 2014, we established interim final rates for four epidural injection procedures, CPT codes 62310 (Injection(s), of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, includes contrast for localization when performed, epidural or subarachnoid; cervical or thoracic), 62311 (Injection(s), of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, includes contrast for localization when performed, epidural or subarachnoid; lumbar or sacral (caudal)), 62318 (Injection(s), including indwelling catheter placement, continuous infusion or intermittent bolus, of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, includes contrast for localization when performed, epidural or subarachnoid; cervical or thoracic) and 62319 (Injection(s), including indwelling catheter placement, continuous infusion or intermittent bolus, of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, includes contrast for localization when performed, epidural or subarachnoid; lumbar or sacral (caudal)). These interim final values resulted in CY 2014 payment reductions from the CY 2013 rates for all four procedures.

    In the CY 2014 final rule with comment period (78 FR 74340), we described in detail our interim valuation of these codes. We indicated we established interim final work RVUs for these codes that were less than those recommended by the RUC because we did not believe that the RUC-recommended work RVUs accounted for the substantial decrease in time it takes to furnish these services as reflected in the RUC survey data for these four codes. Since the RUC provided no indication that the intensity of the procedures had changed, we indicated that we believed the work RVUs should reflect the reduction in time. We also established interim final direct PE inputs for these four codes based on the RUC-recommended inputs without any refinement. These recommendations included the removal of the radiographic-fluoroscopy room for CPT codes 62310, 62311, and 62318 and a portable C-arm for CPT code 62319.

    In response to the comments we received objecting to the CY 2014 interim final values for these codes, we looked at other injection procedures. Other injection procedures, including some that commenters recommended we use to value these epidural injection codes, include the work and practice expenses of image guidance in the injection code. In the proposed rule, we detailed many of these procedures, which include the image guidance in the injection CPT code. Since our analysis of the Medicare data and comments received on the CY 2014 final rule with comment period indicated that these services are typically furnished with imaging guidance, we believe it would be appropriate for the codes to be bundled and the inputs for image guidance to be included in the valuation of the epidural injection codes as it is for transforaminal and paravertebral codes. We stated that we did not believe the epidural injection codes can be appropriately valued without considering the image guidance, and that bundling image guidance will help assure relativity with other injection codes that include the image guidance. To determine how to appropriately value resources for the combined codes, we indicated that we believed more information is needed. Accordingly, we proposed to include CPT codes 62310, 62311, 62318, and 62319 on the potentially misvalued code list so that we can obtain information to value them with the image guidance included. In the meantime, we proposed to use the CY 2013 input values for CPT codes 62310, 62311, 62318 and 62319 to value these codes for CY 2015. Specifically, we proposed to use the CY 2013 work RVUs and work times.

    Because it was clear that inputs that are specifically related to image guidance, such as the radiographic fluoroscopic room, are included in these proposed direct PE inputs for the epidural injection codes, we believed allowing separate reporting of the image guidance codes would overestimate the resources used in furnishing the overall service. To avoid this situation, we also proposed to prohibit the billing of image guidance codes in conjunction with these four epidural injection codes. We stated that we believed our two-tiered proposal to utilize CY 2013 input values for this family while prohibiting separate billing of imaging guidance best ensures that appropriate reimbursements continue to be made for these services, while we gather additional data and input on the best way to value them through codes that include both the injection and the image guidance.

    Comment: The commenters did not object to identifying these codes as potentially misvalued and generally agreed with our proposal to revert to the 2013 inputs for CY 2015.

    Response: We appreciate support for our proposal.

    Comment: Several commenters agreed that it would be appropriate to bundle the image guidance with the epidural procedures. Other commenters suggested that we create both a bundled code and a stand-

    alone epidural injection code.

    Response: We appreciate commenters' support for our proposal to bundle image guidance with the epidural procedures. As part of the review process, consideration can be given to how to best implement bundled codes.

    Comment: Other commenters expressed concern that the bundling approach CMS proposed to use until these codes are reviewed did not incorporate the work or time for fluoroscopy. Some requested that we add the payment for fluoroscopic guidance to the epidural injection codes, as we have done in the past for facet joint injections and other services. Commenters requested that we continue to allow the image guidance codes to be separately billed until these services are revalued. Another commenter suggested that it may be premature to prohibit separate billing for image guidance, as there is considerable variation on the

    Page 67579

    use of fluoroscopic guidance between codes within this family.

    Response: We understand commenters' concerns about our proposal to prohibit separate billing for image guidance, and note that these concerns are part of the reason we are referring these codes to the RUC as potentially misvalued. However, given that significant resources are allocated to fluoroscopic guidance within the current injection codes, we do not believe it is appropriate to continue to allow the image guidance to be separately billed while we evaluate these epidural injection codes as potentially misvalued services.

    After considering comments received, we are finalizing CPT codes 62310, 62311, 62318, and 62319 as potentially misvalued, finalizing the proposed RVUs for these services, and prohibiting separate billing of image guidance in conjunction with these services.

    (3) Neurostimulator Implantation (CPT Codes 64553 and 64555)

    We proposed CPT codes 64553 (Percutaneous implantation of neurostimulator electrode array; cranial nerve) and 64555 (Percutaneous implantation of neurostimulator electrode array; peripheral nerve (excludes sacral nerve)) as potentially misvalued after stakeholders questioned whether the codes included the appropriate direct PE inputs when furnished in the nonfacility setting.

    Comment: A commenter encouraged CMS to include these codes on the potentially misvalued code list to ensure that they are adequately reimbursed in the nonfacility setting, while another commenter disagreed that the work for CPT codes 64553 and 64555 needed to be reviewed.

    Response: In general, when a code is proposed as potentially misvalued, unless we receive information that clearly demonstrates it is not potentially misvalued, we finalize the code as potentially misvalued. When we finalize a code as potentially misvalued, we then review the inputs for the code. As a result of such review, inputs can be adjusted either upward or downward.

    We appreciate the support for our proposal expressed by some commenters. Since the commenter opposing the addition of these codes to the potentially misvalued code list did not provide justification for its assertion that the work RVUs for CPT codes 64553 and 64555 did not need to be reviewed, after consideration of comments received, we are finalizing CPT codes 64553 and 64555 as potentially misvalued.

    (4) Mammography (CPT Codes 77055, 77056, and 77057, and HCPCS Codes G0202, G0204, and G0206)

    Medicare currently pays for mammography services through both CPT codes, (77055 (mammography; unilateral), 77056 (mammography; bilateral) and 77057 (screening mammography, bilateral (2-view film study of each breast)) and HCPCS G-codes, (G0202 (screening mammography, producing direct digital image, bilateral, all views), G0204 (diagnostic mammography, producing direct digital image, bilateral, all views), and G0206 (diagnostic mammography, producing direct digital image, unilateral, all views)). The CPT codes were designed to be used for mammography regardless of whether film or digital technology is used. However, for Medicare purposes, the HCPCS G-codes were created to describe mammograms using digital technology in response to special payment rules for digital mammography included in the Medicare Benefit Improvements and Protection Act of 2000 (BIPA).

    The RUC recommended that CMS update the direct PE inputs for all imaging codes to reflect the migration from film-to-digital storage technologies since digital storage is now typically used in imaging services. Review of the Medicare data with regard to the application of this policy to mammography confirmed that virtually all mammography is now digital. As a result, we proposed that CPT codes 77055, 77056, and 77057 be used to report mammography regardless of whether film or digital technology is used, and to delete the HCPCS G-codes G0202, G0204, and G0206. We proposed to establish values for the CPT codes by crosswalking the values established for the digital mammography G-codes for CY 2015. (See section II.B. of this final rule with comment period for more discussion of this policy.) In addition, since the G-code values have not been evaluated since they were created in CY 2002 we proposed to include CPT codes 77055, 77056, and 77057 on the list of potentially misvalued codes.

    Comment: With regard to whether the mammography codes should be included on the potentially misvalued codes list, commenters had differing opinions. One commenter stated that the work RVUs for digital mammography are the same as those for analog mammography, and maintained that the BIPA-directed payment for digital mammography of 1.5 times the TC of the analog mammography codes appropriately captures the practice expense resources required for digital mammography. Another commenter stated that digital mammography rates resulted from a statutory construct and do not reflect the actual costs of the digital resources necessary to furnish the services. One commenter noted that moving from the non-resource-based values to resource-based values will result in a significant reduction to the valuation of these services, and that this reduction will result from the resource-based PE methodology, not from the RUC review. Another commenter indicated that the RUC should not survey these codes, but requested that if the RUC does survey these codes, they should not do so until after CMS finalizes the new breast tomosynthesis codes (3D mammography) and film-

    to-digital transition. Another commenter indicated that CMS needed to consider that three-dimensional (3D) mammography codes involve additional resources over the two-dimensional (2D) mammography codes. A commenter suggested that this proposal fails to take into account the increasing use of tomography.

    Response: The commenters' disagreement about whether these codes are misvalued would suggest that a review is warranted. Given that more than a decade has passed since these services were reviewed, we continue to believe that it is appropriate to review the work RVUs for these services. By including these codes on the potentially misvalued code list, we will have information to determine whether the current values are still appropriate. Finally, we anticipate that the survey results for the mammography codes will reflect the equipment that is typically used. We note that until these services are reviewed, we do not have adequate information to respond to the suggestion that the valuation for these services will be significantly reduced. However, we do acknowledge that the PE methodology is not intended to account for the actual costs in furnishing a service; rather, it is required to account for the relative resources in furnishing that service. We also note that there are new CPT codes for reporting mammography using tomosynthesis and we have RUC recommendations for these codes. We believe it is most appropriate to value the mammography code family together, and receipt of RUC recommendations on the other mammography codes will assist us in our review. Accordingly, we are including all mammography codes except those newly created for tomosynthesis on the potentially misvalued code list.

    Comment: Although commenters agreed with our assessment that digital

    Page 67580

    technology has replaced analog mammography as typical, not all agreed that it was appropriate to delete G-codes and use the CPT codes. One commenter supported the deletion of the G-codes. Other commenters suggested that deletion of the G-codes was unnecessary. Another commenter stated that the coding system frequently reflects differences in approach and technique, and that the equipment for analog and digital mammography are different enough to warrant separate reporting so we should not delete the G-codes. Some who supported continuation of the G-codes asked us to delay implementation as they were concerned that other payers would not have time to update their requirements by January 1, 2015. Another commenter applauded CMS's decision to delete the G-codes.

    Response: In further consideration of this proposal, we discovered that while the CPT codes for diagnostic mammography apply to mammography, whether film or digital technology is used, the descriptor for the screening mammography CPT code specifically refers to film. In light of this and that fact that we anticipate revaluing these codes when we have the benefit of RUC recommendations for all codes in the family, we believe it is appropriate to continue to recognize both the CPT codes and the G-codes for mammography for CY 2015, as we consider appropriate valuations now that digital mammography is typical. Therefore, we are not finalizing our proposal to delete the G-codes. We are, however, making a change in the descriptors to make clear that the G0202, G0204, and G0206 are specific to 2-D mammography. These codes are to be reported with either G0279 or CPT code 77063 when mammography is furnished using 3-D mammography.

    Comment: A commenter requested that CMS ensure reimbursement rates remain adequate to protect access for Medicare beneficiaries. Another commenter suggested that these changes could result in barriers to access for Medicare beneficiaries.

    Response: We are strongly supportive of access to mammography for Medicare beneficiaries. As stated elsewhere in this final rule with comment period, we believe that accurate valuation incentivizes appropriate utilization of services.

    After consideration of public comments, we are modifying our proposal as follows: We will include CPT codes 77055, 77056, and 77057 on the potentially misvalued codes list; we will continue to recognize G0202, G0204 and G0206 but will modify the descriptors so that they are specific to 2-D digital mammography, and instead of using the digital values we will continue to use the CY 2014 work and PE RVUs to value the mammography CPT codes. We expect that the CPT Editorial Panel will consider the descriptor for screening mammography, CPT code 77057, in light of the prevailing use of digital mammography.

    (5) Abdominal Aortic Aneurysm Ultrasound Screening (G0389)

    When Medicare began paying for abdominal aortic aneurysm (AAA) ultrasound screening, HCPCS code G0389 (Ultrasound, B-scan and/or real time with image documentation; for abdominal aortic aneurysm (AAA) screening) in CY 2007, we set the RVUs at the same level as CPT code 76775 (Ultrasound, retroperitoneal (e.g., renal, aorta, nodes), B-scan and/or real time with image documentation; limited). We noted in the CY 2007 final rule with comment period that CPT code 76775 was used to report the service when furnished as a diagnostic test and that we believed the service reflected by G0389 used equivalent resources and work intensity to those contained in CPT code 76775 (71 FR 69664 through 69665).

    In the CY 2014 proposed rule, we proposed to replace the ultrasound room included as a direct PE input for CPT code 76775 with a portable ultrasound unit based upon a RUC recommendation. Since the RVUs for G0389 were crosswalked from CPT code 76775, the proposed PE RVUs for G0389 in the CY 2014 proposed rule were reduced as a result of this change. However, we did not discuss the applicability of this change to G0389 in the preamble to the proposed rule, and did not receive any comments on G0389 in response to the proposed rule. We finalized the change to CPT code 76775 in the CY 2014 final rule with comment period and as a result, the PE RVUs for G0389 were also reduced.

    We proposed G0389 as potentially misvalued in response to a stakeholder suggestion that the reduction in the RVUs for G0389 did not accurately reflect the resources involved in furnishing the service. We sought recommendations from the public and other stakeholders, including the RUC, regarding the appropriate work RVU, time, direct PE input, and malpractice risk factors that reflect the typical resources involved in furnishing the service.

    Until we receive the information needed to re-value this service, we proposed to value this code using the same work and PE RVUs we used for CY 2013. We proposed MP RVUs based on the five-year review update process as described in section II.C of this final rule with comment period. We stated that we believe this valuation would ameliorate the effect of the CY 2014 reduction that resulted from the RVUs for G0389 being tied to those for another code while we assess appropriate valuation through our usual methodologies. Accordingly, we proposed a work RVU of 0.58 for G0389 and proposed to assign the 2013 PE RVUs until this procedure is reviewed.

    Comment: Many commenters supported our proposal to include this service on the potentially misvalued codes list. Some commenters agreed that the crosswalk used to set rates for this service does not appear to be appropriate at this time, whether due to changes in the way the service is provided, or because the specialty mix has shifted, and suggested that it would be appropriate to establish a Category I CPT code for this service. Another commenter suggested that CMS consider crosswalking G0389 to CPT code 93979 (Duplex scan of aorta, inferior vena cava, iliac vasculature, or bypass grafts; unilateral or limited study). One commenter believed it was unnecessary to survey this code, but recommended that we instead maintain the general ultrasound room as a direct PE input and 2013 PE RVUs.

    Response: We appreciate commenters' support for our proposal to include G0389 on the potentially misvalued codes list and are finalizing this proposal. We are finalizing this code as potentially misvalued in large part because we are unsure of the correct valuation. Therefore, we believe it is most appropriate to retain the 2013 inputs until we receive new recommendations, rather than making another change or retaining these inputs indefinitely as commenters suggested.

    After consideration of comments received, we are finalizing our proposal to add G0389 to the potentially misvalued codes list, and to maintain the 2013 work and PE RVUs while we complete our review of the code. The MP RVUs will be calculated as discussion in section II.C. of this rule.

    (6) Prostate Biopsy Codes--(HCPCS Codes G0416, G0417, G0418, and G0419)

    For CY 2014, we modified the code descriptors of G0416 through G0419 so that these codes could be used for any method of prostate needle biopsy services, rather than only for prostate saturation biopsies. The CY 2014 descriptions are:

    Page 67581

    G0416 (Surgical pathology, gross and microscopic examination for prostate needle biopsies, any method; 10-20 specimens).

    G0417 (Surgical pathology, gross and microscopic examination for prostate needle biopsies, any method; 21-40 specimens).

    G0418 (Surgical pathology, gross and microscopic examination for prostate needle biopsies, any method; 41-60 specimens).

    G0419 (Surgical pathology, gross and microscopic examination for prostate needle biopsies, any method; greater than 60 specimens).

    Subsequently, we have discussed prostate biopsies with stakeholders, and reviewed medical literature and Medicare claims data in considering how best to code and value prostate biopsy pathology services. After considering these discussions and information, we believed it would be appropriate to use only one code to report prostate biopsy pathology services. Therefore, we proposed to revise the descriptor for G0416 to define the service regardless of the number of specimens, and to delete codes G0417, G0418, and G0419. We believe that using G0416 to report all prostate biopsy pathology services, regardless of the number of specimens, would simplify the coding and mitigate overutilization incentives. Given the infrequency with which G0417, G0418, and G0419 are used, we did not believe that this was a significant change.

    Based on our review of medical literature and examination of Medicare claims data, we indicated that we believe that the typical number of specimens evaluated for prostate biopsies is between 10 and 12. Since G0416 currently is used for between 10 and 12 specimens, we proposed to use the existing values for G0416 for CY 2015, since the RVUs for this service were established based on similar assumptions.

    In addition, we proposed G0416 as a potentially misvalued code for CY 2015 and sought public comment on the appropriate work RVUs, work time, and direct PE inputs.

    Comment: One commenter supported the elimination of the G-codes as a means of simplifying coding requirements, but other commenters opposed our proposal to consolidate the coding into G0416, disagreeing that this would help establish ``straightforward coding and maintain accurate payment'' as suggested in the proposed rule. Some commenters suggested that we retain the current codes so that biopsy procedures requiring more than 10 specimens can be reimbursed accurately, and indicated that consolidating the coding would further confuse physicians and their staff who have not yet adapted to the CY 2014 coding changes for these G-codes. Other commenters asserted that these changes threaten to undermine access to high quality pathology services. Commenters also stated that the decision to furnish more extensive pathological analysis is not at the discretion of the pathologist, and the pathologist should not be penalized when he or she receives more cores to analyze.

    With respect to our proposing G0416 as potentially misvalued, commenters stated that the recent change to these codes has already been confusing and suggests that there is not a clear understanding of what these codes represent, thus making an assessment of their valuation difficult. Commenters further stated that it is unreasonable to consider this a misvalued code when the payment is already 30 percent below what they think it should be, and that CMS has failed to provide justification for why it is potentially misvalued.

    The RUC and others suggested that it would be most accurate to utilize CPT code 88305 (Level IV--surgical pathology, gross and microscopic examination) for the reporting of prostate biopsies and to allow the reporting of multiple units. Given the additional granularity and scrutiny given to CPT code 88305 in the CY 2014 final rule, the commenters indicated that they believe that the agency's intent to establish straightforward coding and accurate payment for these services would be realized with this approach.

    Response: Given that the typical analysis of prostate biopsy specimens differs significantly from the typical analyses reported using CPT code 88305, as regards the number of blocks used to process the specimen and thus the amount of work involved, we believe that by distinguishing prostate biopsies from other types of biopsies results in more accurate pricing for prostate biopsies. Since CPT code 88305 was revalued with the understanding that prostate biopsies are billed separately, we believe that allowing CPT code 88305 to be reported in multiple units for prostate biopsies would account for significantly more resources than is appropriate. With respect to the concern about higher numbers of specimens, we note that our claims data on the G-

    codes shows that the vast majority of the claims used G0416, rather than any of the G-codes for greater numbers of specimens.

    After consideration of comments received, we are finalizing our proposal to include G0416 on the potentially misvalued codes list, to modify the descriptor to reflect all prostate biopsies, and to maintain the current value until we receive and review information and recommendations from the RUC. We are also finalizing our proposal to delete codes G0417, G0418, and G0419.

    (7) Obesity Behavioral Group Counseling--GXXX2 and GXXX3

    Pursuant to section 1861(ddd) of the Act, we added coverage for a new preventive benefit, Intensive Behavioral Therapy for Obesity, effective November 29, 2011, and created HCPCS code G0447 (Face-to-face behavioral counseling for obesity, 15 minutes) for reporting and payment of individual behavioral counseling for obesity. Coverage requirements specific to this service are delineated in the Medicare National Coverage Determinations Manual, Pub. 100-03, Chapter 1, Section 210, available at http://www.cms.gov/manuals/downloads/ncd103c1_Part4.pdf.

    It was brought to our attention that behavioral counseling for obesity is sometimes furnished in group sessions, and questions were raised about whether group sessions could be billed using HCPCS code G0447. To improve payment accuracy, we proposed to create two new HCPCS codes for the reporting and payment of group behavioral counseling for obesity. Specifically, we proposed to create GXXX2 (Face-to-face behavioral counseling for obesity, group (2-4), 30 minutes) and GXXX3 (Face-to-face behavioral counseling for obesity, group (5-10), 30 minutes). We indicated that the coverage requirements for these services would remain in place, as described in the National Coverage Determination for Intensive Behavioral Therapy for Obesity cited above. The practitioner furnishing these services would report the relevant group code for each beneficiary participating in a group therapy session.

    Since we believed that the face-to-face behavioral counseling for obesity services described by GXXX2 and GXXX3 would require similar per minute work and intensity as HCPCS code G0447, we proposed work RVUs of 0.23 and 0.10 for HCPCS codes GXXX2 and GXXX3, with work times of 8 minutes and 3 minutes respectively. Since the services described by GXXX2 and GXXX3 would be billed per beneficiary receiving the service, the work RVUs and work time that we proposed for these codes were based upon the assumed typical number of beneficiaries per session, 4 and 9, respectively. Accordingly, we proposed

    Page 67582

    a work RVU of 0.23 with a work time of 8 minutes for GXXX2 and a work RVU of 0.10 with a work time of 3 minutes for GXXX3. We proposed to use the direct PE inputs for GXXX2 and GXXX3 currently included for G0447 prorated to account for the differences in time and number of beneficiaries, and to crosswalk the malpractice risk factor from HCPCS code G0447 to both HCPCS codes GXXX2 and GXXX3, as we believe the same specialty mix will furnish these services. We requested public comment on the proposed values for HCPCS codes GXXX2 and GXXX3.

    Comment: Commenters generally supported our proposal to establish a separate payment mechanism for obesity behavioral group counseling services, but raised several concerns regarding the coding structure and valuation of these services. Commenters stated that the work times were inaccurate, requested that the service be valued based on a smaller number of typical group participants, and questioned the need for two G-codes when group counseling services under the PFS are generally billed with a single G-code. A commenter also stated that the lower payment for larger groups will create disincentives for furnishing this service except when there is a full 10-person group, which could limit access. Commenters suggested that CMS only finalize a single G-code for group counseling for intensive behavioral therapy for obesity, and crosswalk the work RVU and work time for this service from the Medical Nutrition Therapy (MNT) group code.

    Response: We appreciate commenters' support for our proposal to provide new codes for group obesity counseling services. After reviewing the comments, we agree that it is reasonable to create a single code for group obesity counseling and crosswalk the work RVU and work time from the MNT group code. The individual code for intensive obesity behavioral therapy and the individual MNT code are valued the same, so in the absence of evidence that group composition is different, we believe it makes sense to use the same values. Therefore, we will crosswalk the work RVU of 0.25 and the work time of 10 minutes to a single new G-code for group obesity counseling, G0473 (Face-to-

    face behavioral counseling for obesity, group (2-10), 30 minutes).

    4. Improving the Valuation and Coding of the Global Package

  30. Overview

    Since the inception of the PFS, we have valued and paid for certain services, such as surgery, as part of global packages that include the procedure and the services typically furnished in the periods immediately before and after the procedure (56 FR 59502). For each of these codes (usually referred to as global surgery codes), we establish a single PFS payment that includes payment for particular services that we assume to be typically furnished during the established global period.

    There are three primary categories of global packages that are labeled based on the number of post-operative days included in the global period: 0-day; 10-day; and 90-day. The 0-day global codes include the surgical procedure and the pre-operative and post-operative physicians' services on the day of the procedure, including visits related to the service. The 10-day global codes include these services and, in addition, visits related to the procedure during the 10 days following the procedure. The 90-day global codes include the same services as the 0-day global codes plus the pre-operative services furnished one day prior to the procedure and post-operative services during the 90 days immediately following the day of the procedure.

    Section 40.1 of the Claims Processing Manual (Pub. 100-04, Chapter 12 Physician/Nonphysician Practitioners) defines the global surgical package to include the following services when furnished during the global period:

    Preoperative Visits--Preoperative visits after the decision is made to operate beginning with the day before the day of surgery for major procedures and the day of surgery for minor procedures;

    Intra-operative Services--Intra-operative services that are normally a usual and necessary part of a surgical procedure;

    Complications Following Surgery--All additional medical or surgical services required of the surgeon during the postoperative period of the surgery because of complications that do not require additional trips to the operating room;

    Postoperative Visits--Follow-up visits during the postoperative period of the surgery that are related to recovery from the surgery;

    Postsurgical Pain Management--By the surgeon;

    Supplies--Except for those identified as exclusions; and

    Miscellaneous Services--Items such as dressing changes; local incisional care; removal of operative pack; removal of cutaneous sutures and staples, lines, wires, tubes, drains, casts, and splints; insertion, irrigation and removal of urinary catheters, routine peripheral intravenous lines, nasogastric and rectal tubes; and changes and removal of tracheostomy tubes.

  31. Concerns With the 10- and 90-Day Global Packages

    CMS supports bundled payments as a mechanism to incentivize high-

    quality, efficient care. Although on the surface, the PFS global codes appear to function as bundled payments similar to those Medicare uses to make single payments for multiple services to hospitals under the inpatient and outpatient prospective payment systems, the practical reality is that these global codes function significantly differently than other bundled payments. First, the global surgical codes were established several decades ago when surgical follow-up care was far more homogenous than today. Today, there is more diversity in the kind of procedures covered by global periods, the settings in which the procedures and the follow-up care are furnished, the health care delivery system and business arrangements used by Medicare practitioners, and the care needs of Medicare beneficiaries. Despite these changes, the basic structures of the global surgery packages are the same as the packages that existed prior to the creation of the resource-based relative value system in 1992. Another significant difference between this and other typical models of bundled payments is that the payment rates for the global surgery packages are not updated regularly based on any reporting of the actual costs of patient care. For example, the hospital inpatient and outpatient prospective payment systems (the IPPS and OPPS, respectively) derive payment rates from hospital cost and charge data reported through annual Medicare hospital cost reports and the most recent year of claims data available for an inpatient stay or primary outpatient service.

    Because payment rates are based on consistently updated data, over time, payment rates adjust to reflect the average resource costs of current practice. Similarly, many of the new demonstration and innovation models track costs and make adjustments to payments. Another significant difference is that payment for the PFS global packages relies on valuing the combined services together. This means that there are no separate PFS values established for the procedures or the follow-up care, making it difficult to estimate the costs of the individual global code component services.

    In the following paragraphs, we address a series of concerns regarding the accuracy of payment for 10- and 90-day global codes, including: The fundamental difficulties in establishing

    Page 67583

    appropriate relative values for these packages, the potential inaccuracies in the current information used to price global codes, the limitations on appropriate pricing in the future, the potential for global packages to create unwarranted payment differentials among specialties, the possibility that the current codes are incompatible with current medical practice, and the potential for these codes to present obstacles to the adoption of new payment models.

    Concerns such as these commonly arise when developing payment mechanisms, for example fee-for-service payment rates, single payments for multiple services, or payment for episodes of care over a period of time. However, in the case of the post-operative portion of the 10- and 90-day global codes, we believe that together with certain unique aspects of PFS rate setting methodology, these concerns create substantial barriers to accurate valuation of these services relative to other PFS services.

    (1) Fundamental Limitations in the Appropriate Valuation of the Global Packages With Post-Operative Days

    In general, we face many challenges in valuing PFS services as accurately as possible. However, the unique nature of global surgery packages with 10- and 90-day post-operative periods presents additional challenges distinct from those presented in valuing other PFS services. Our valuation methodology for PFS services generally relies on assumptions regarding the resources involved in furnishing the ``typical case'' for each individual service unlike other payment systems that rely on actual data on the costs of furnishing services. Consistent with this valuation methodology, the RVUs for a global code should reflect the typical number and level of E/M services furnished in connection with the procedure. However, it is much easier to maintain relativity among services that are valued on this basis when each of the services is described by codes of similar unit sizes. In other words, because codes with long post-operative periods include such a large number of services, any variations between the ``typical'' resource costs used to value the service and the actual resource costs associated with particular services are multiplied. The effects of this problem can be two-fold, skewing the accuracy of both the RVUs for individual global codes and the Medicare payment made to individual practitioners. The RVUs of the individual global service codes are skewed whenever there is any inaccuracy in the assumption of the typical number or kind of services in the post-operative periods. This inaccuracy has a greater impact than inaccuracies in assumptions for non-global codes because it affects a greater number of service units over a period of time than for individually priced services. Furthermore, in contrast to prospective payment systems, such inaccuracies under the PFS are not corrected over time through a ratesetting process that makes year-to-year adjustments based on data on actual costs. For example, if a 90-day global code is valued based on an assumption or survey response that ten post-operative visits is typical, but practitioners reporting the code in fact typically only furnish six visits, then the resource assumptions are overestimated by the value of the four visits multiplied by the number of the times the procedure code is reported. In contrast, when our assumptions are incorrect about the typical resources involved in furnishing a PFS code that describes a single service, any inaccuracy in the RVUs is limited to the difference between the resource costs assumed for the typical service and the actual resource costs in furnishing one individual service. Such a variation between the assumptions used in calculating payment rates and the actual resource costs could be corrected if the payments for packaged services were updated regularly using data on actual services furnished. Medicare's prospective payment systems have more mechanisms in place than the PFS does to adjust over time for such variation To make adjustments to the RVUs to account for inaccurate assumptions under the current PFS methodology, the global surgery code would need to be identified as potentially misvalued, survey data would have to reflect an accurate account of the number and level of typical post-operative visits, and we (with or without a corresponding recommendation from the RUC or others) would have to implement a change in RVUs based on the change in the number and level of visits to reflect the typical service.

    These amplified inaccuracies may also occur whenever Medicare pays an individual practitioner reporting a 10- or 90-day global code. Practitioners may furnish a wide range of post-operative services to individual Medicare beneficiaries, depending on individual patient needs, changes in medical practice, and dynamic business models. Due to the way the 10- and 90-day global codes are constructed, the number and level of services included for purposes of calculating the payment for these services may vary greatly from the number and level of services that are actually furnished in any particular case. In contrast, the variation between the ``typical'' and the actual resource cost for the practitioner reporting an individually valued PFS service is constrained because the practitioner is only reporting and being paid for a specific service furnished on a particular date.

    For most PFS services, any difference between the ``typical'' case on which RVUs are based and the actual case for a particular service is limited to the variation between the resources assumed to be involved in furnishing the typical case and the actual resources involved in furnishing the single specific service. When the global surgical package includes more or a higher level of E/M services than are actually furnished in the typical post-operative period, the Medicare payment is based on an overestimate of the quantity or kind of services furnished, not merely an overestimation of the resources involved in furnishing an individual service. The converse is true if the RVUs for the global surgical package are based on fewer or a lower level of services than are typically furnished for a particular code.

    (2) Questions Regarding Accuracy of Current Assumptions

    In previous rulemaking (77 FR 68911 through 68913), we acknowledged evidence suggesting that the values included in the post-operative period for global codes may not reflect the typical number and level of post-operative E/M visits actually furnished.

    In 2005, the OIG examined whether global surgical packages are appropriately valued. In its report on eye and ocular surgeries, ``National Review of Evaluation and Management Services Included in Eye and Ocular Adnexa Global Surgery Fees for Calendar Year 2005'' (A-05-

    07-00077), the OIG reviewed a sample of 300 eye and ocular surgeries, and counted the actual number of face-to-face services recorded in the patients' medical records to establish whether and, if so, how many post-operative E/M services were furnished by the surgeons. For about two-thirds of the claims sampled by the OIG, surgeons furnished fewer E/M services in the post-operative period than were included in the global surgical package payment for each procedure. A small percentage of the surgeons furnished more E/M services than were included in the global surgical package payment. The OIG identified the number of face-

    to-face services recorded in the medical record, but did not review the medical necessity

    Page 67584

    of the surgeries or the related E/M services. The OIG concluded that the RVUs for these global surgical packages are too high because they include a higher number of E/M services than typically are furnished within the global period for the reviewed procedures.

    Following that report, the OIG continued to investigate E/M services furnished during global surgical periods. In May 2012, the OIG published a report entitled ``Musculoskeletal Global Surgery Fees Often Did Not Reflect the Number of Evaluation and Management Services Provided'' (A-05-09-00053). For this investigation, the OIG sampled 300 musculoskeletal global surgeries and again found that, for the majority of sampled surgeries, physicians furnished fewer E/M services than were included as part of the global period payment for that service. Once again, a small percentage of surgeons furnished more E/M services than were included in the global surgical package payment. The OIG concluded that the RVUs for these global surgical packages are too high because they include a higher number of E/M services than typically are furnished within the global period for the reviewed procedures.

    In both reports, the OIG recommended that we adjust the number of E/M services identified with the studied global surgical payments to reflect the number of E/M services that are actually being furnished. However, since it is not necessary under our current global surgery payment policy for a surgeon to report the individual E/M services actually furnished during the global surgical period, we do not have objective data upon which to assess whether the RVUs for global period surgical services reflect the typical number or level of E/M services that are furnished. In the CY 2013 PFS proposed rule (77 FR 44738), we previously sought public comments on collecting these data. As summarized in the CY 2013 PFS final rule (77 FR 68913) we did not discover a consensus among stakeholders regarding either the most appropriate means to gather the data, or the need for, or the appropriateness of using such data in valuing these services. In response to our comment solicitation, some commenters urged us to accept the RUC survey data as accurate in spite of the OIG reports and other concerns that have been expressed regarding whether the visits included in the global periods reflected the typical case. Others suggested that we should conduct new surveys using the RUC approach or that we should mine hospital data to identify the typical number of visits furnished. Some comments suggested eliminating the 10- and 90-

    day global codes.

    (3) Limitations on Appropriate Future Valuations of 10- and 90-Day Global Codes

    Historically, our attempts to adjust RVUs for global services based on changes in the typical resource costs (especially with regard to site of service assumptions or changes to the number of post-surgery visits) have been difficult and controversial. At least in part, this is because the relationship between the work RVUs for the 10- and 90-

    day global codes (which includes the work RVU associated with the procedure itself) and the number of included post-operative visits in the existing values is not always clear. Some services with global periods have been valued by adding the work RVU of the surgical procedure and all pre- and post-operative E/M services included in the global period. However, in other cases, as many stakeholders have noted, the total work RVUs for surgical procedures and post-operative visits in global periods are estimated as a single value without any explicit correlation to the time and intensity values for the individual service components. Although we would welcome more objective information to improve our determination of the ``typical'' case, we believe that even if we engaged in the collection of better data on the number and level of E/M services typically furnished during the global periods for global surgery services, the valuation of individual codes with post-operative periods would not be straightforward. Furthermore, we believe it would be important to frequently update the data on the number and level of visits furnished during the post-operative periods in order to account for any changes in the patient population, medical practice, or business arrangements. Practitioners paid through the PFS do not report such data.

    (4) Unwarranted Payment Disparities

    Subsequent to our last comment solicitation regarding the valuation of the post-operative periods (77 FR 68911 through 68913), some stakeholders have raised concerns that global surgery packages contribute to unwarranted payment disparities between practitioners who do and do not furnish these services. These stakeholders have addressed several ways the 10- and 90-day global packages may contribute to unwarranted payment disparities.

    The stakeholders noted that, through the global surgery packages, Medicare pays practitioners who furnish E/M services during post-

    surgery periods regardless of whether the services are actually furnished, while practitioners who do not furnish global procedures with post-operative visits are only paid for E/M services that are actually furnished. In some cases, it is possible that the practitioner furnishing the global surgery procedure may not furnish any post-

    operative visits. Although we have policies to address the situation when post-operative care is transferred from one practitioner to another, the beneficiary might simply choose to seek care from another practitioner without a formal transfer of care. The other practitioner would then bill Medicare separately for E/M services for which payment was included in the global payment to the original practitioner. Those services would not have been separately billable if furnished by the original practitioner.

    These circumstances can lead to unwarranted payment differences, allowing some practitioners to receive payment for fewer services than reflected in the Medicare payment. Practitioners who do not furnish global surgery services bill and are paid only for each individual service furnished. When global surgery values are based on inaccurate assumptions about the typical services furnished in the post-operative periods, these payment disparities can contribute to differences in aggregate RVUs across specialties. Since the RVUs are intended to reflect differences in the relative resource costs involved in furnishing a service, any disparity between assumed and actual costs results not only in paying some practitioners for some services that are not furnished, it also skews relativity between specialties.

    Stakeholders have also pointed out that payment disparities can arise because E/M services reflected in global periods generally include higher PE values than the same services when billed separately. The difference in PE values between separately billed visits and those included in global packages result primarily from two factors that are both inherent in the PFS pricing methodology.

    First, there is a different mix of PE inputs (clinical labor/

    supplies/equipment) included in the direct PE inputs for a global period E/M service and a separately billed E/M service. For example, the clinical labor inputs for separately reportable E/M codes includes a staff blend listed as ``RN/LPN/MTA'' (L037D) and priced at $0.37 per minute. Instead of this input, some codes with post-operative visits include the staff type ``RN'' (L051A) priced at a higher rate of $0.51 per minute. For these codes, the higher resource cost

    Page 67585

    may accurately reflect the typical resource costs associated with those particular visits. However, the different direct PE inputs may drive unwarranted payment disparities among specialties who report global surgery codes with post-operative periods and those that do not. The only way to correct these potential discrepancies under the current system, which result from the specialty-based differences in resource costs, would be to include standard direct PE inputs for these services regardless of whether or not the standard inputs are typical for the specialties furnishing the services.

    Second, the indirect PE allocated to the E/M visits included in global surgery codes is higher than that allocated to separately furnished E/M visits. This occurs because the range of specialties furnishing a particular global service is generally not as broad as the range of specialties that report separate individual E/M services. Since the specialty mix for a service is a key factor in determining the allocation of indirect PE to each code, a higher amount of indirect PE can be allocated to the E/M services that are valued as part of the global surgery codes than to the individual E/M codes. Practitioners who use E/M codes to report visits separately are paid based on PE RVUs that reflect the amount of indirect PE allocated across a wide range of specialties, which has the tendency to lower the amount of indirect PE. For practitioners who are paid for visits primarily through post-

    operative periods, indirect PE is generally allocated with greater specificity. Two significant steps would be required to alleviate the impact of this disparity. First, we would have to identify the exact mathematical relationship between the work RVU and the number and level of post-operative visits for each global code; and second, we would have to propose a significant alteration of the PE methodology in order to allocate indirect PE that does not correlate to the specialties reporting the code in the Medicare claims data.

    Furthermore, stakeholders have pointed out that the PE RVUs for codes with 10- or 90-day post-operative periods reflect the assumption that all outpatient visits occur in the higher-paid non-facility office setting, when many of these visits are likely to be furnished in provider-based departments, which would be paid at the lower, PFS facility rate if they were billable separately. As we note elsewhere in this final rule with comment period, we do not have data on the volume of physicians' services furnished in provider-based departments, but public information suggests that it is not insignificant and that it is growing. When these services are paid as part of a global package, there is no adjustment made based on the site of service. Therefore, even though the PFS payment for services furnished in post-operative global periods might include clinical labor, disposable supply, and medical equipment costs (and additional indirect PE allocation) that are incurred by the facility and not the practitioner reporting the service, the RVUs for global codes reflect all of these costs associated with the visits.

    (5) Incompatibility of Current Packages With Current Practice and Unreliability of RVUs for Use in New Payment Models

    In addition to these issues, the 10- and 90-day global periods reflect a long-established but no longer exclusive model of post-

    operative care that assumes the same practitioner who furnishes the procedure typically furnishes the follow-up visits related to that procedure. In many cases, we believe that models of post-operative care are increasingly heterogeneous, particularly given the overall shift of patient care to larger practices or team-based environments.

    We believe that RVUs used to establish PFS payments are likely to serve as critical building blocks to developing, testing, and implementing a number of new payment models, including those that focus on bundled payments to practitioners or payments for episodes of care. Therefore, we believe it is critical for us to ensure that the PFS RVUs accurately reflect the resource costs for individual PFS services instead of reflecting potentially skewed assumptions regarding the number of services furnished over a long period of time in the ``typical'' case. To the extent that the 10- and 90-day global periods reflect inaccurate assumptions regarding resource costs associated with individual PFS services, we believe they are likely to be obstacles to a wide range of potential improvements to PFS payments, including the potential incorporation of payment bundling designed to foster efficiency and quality care for Medicare beneficiaries.

  32. Proposed Transformation of 10- and 90-Day Global Packages Into 0-Day Global Packages

    Although we have marginally addressed some of the concerns noted above with global packages in previous rulemaking, we do not believe that we have made significant progress in addressing the fundamental issues with the 10- and 90-day post-operative global packages. In the context of the misvalued code initiative, we believe it is critical for the RVUs used to develop PFS payment rates reflect the most accurate resource costs associated with PFS services. Based on the issues discussed above, we do not believe we can effectively address the issues inherent in establishing values for the 10- and 90-day global packages under our existing methodologies and with available data. As such, we do not believe that maintaining the post-operative 10-and 90-

    day global periods is compatible with our continued interest in using more objective data in the valuation of PFS services and accurately valuing services relative to each other. Because the typical number and level of post-operative visits during global periods may vary greatly across Medicare practitioners and beneficiaries, we believe that continued valuation and payment of these face-to-face services as a multi-day package may 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, whether through the current PFS or in any number of new payment models. 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.

    To address the issues discussed above, we proposed to retain global bundles for surgical services, but to refine bundles by transforming over several years all 10- and 90-day global codes to 0-day global codes. Medically reasonable and necessary visits would be billed separately during the pre- and post-operative periods outside of the day of the surgical procedure. We propose to make this transition for current 10-day global codes in CY 2017 and for the current 90-day global codes in CY 2018, pending the availability of data on which to base updated values for the global codes.

    We believe 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

    Page 67586

    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.

    As we transition these codes, we would need to establish RVUs that reflect the change in the global period for all the codes currently valued as 10- and 90-day global surgery services. We sought assistance from stakeholders on various aspects of this task. Prior to implementing these changes, we intend to gather objective data on the number of E/M and other services furnished during the current post-

    operative periods and use those data to inform both the valuation of particular services and the overall budget neutrality adjustments required to implement this proposal. We sought comment on the most efficient means of acquiring accurate data regarding the number of visits and other services actually being furnished by the practitioner during the current post-operative periods. For all the reasons stated above, we do not believe that survey data reflecting assumptions of the ``typical case'' meets the standards required to measure the resource costs of the wide range of services furnished during the post-operative periods. We acknowledge that collecting information on these services through claims submission may be the best approach, and we would propose such a collection through future rulemaking. However, we are also interested in alternatives. For example, we sought information on the extent to which individual practitioners or practices may currently maintain their own data on services furnished during the post-operative period, and how we might collect and objectively evaluate that data.

    We also sought comment on the best means to ensure that allowing separate payment of E/M visits during post-operative periods does not incentivize otherwise unnecessary office visits during post-operative periods. If we adopt this proposal, we intend to monitor any changes in the utilization of E/M visits following its implementation but we also solicited comment on potential payment policies that will mitigate such a change in behavior.

    In developing this proposal, we considered several alternatives to the transformation of all global codes to 0-day global codes. First, we again considered the possibility of gathering data and using the data to revalue the 10- and 90-day global codes. While this option would have maintained the status quo in terms of reporting services, it would have required much of the same effort as this proposal without alleviating many of the problems associated with the 10- and 90-day global periods. For example, collecting accurate data would allow for more accurate estimates of the number and kind of visits included in the post-operative periods at the time of the survey. However, this alternative approach would only mitigate part of the potential for unwarranted payment disparities. For example, the values for the visits in the global codes would continue to include different amounts of PE RVUs than separately reportable visits and would continue to provide incentives to some practitioners to minimize patient visits. Additionally, it would not address the changes in practice patterns that we believe have been occurring whereby the physician furnishing the procedure is not necessarily the same physician providing the post-

    procedure follow up.

    This alternative option would also rest extensively on the effectiveness of using the new data to revalue the codes accurately. Given the unclear relationship between the assigned work RVUs and the post-operative visits across all of these services, incorporating objective data on the number of visits to adjust work RVUs would still necessitate extensive review of individual codes or families of codes by CMS and stakeholders, including the RUC. We believe the investment of resources for such an effort would be better made to solve a broader range of problems.

    We also considered other possibilities, such as altering our PE methodology to ensure that the PE inputs and indirect PE for visits in the global period were valued the same as separately reportable E/M codes or requiring reporting of the visits for all 10- and 90-day global services while maintaining the 10- and 90-day global period payment rates. However, we believe this option would require all of the same effort by practitioners, CMS, and other stakeholders without alleviating most of the problems addressed in the preceding paragraphs.

    We also considered maintaining the status quo and identifying each of the 10- and 90-day global codes as potentially misvalued through our potentially misvalued code process for review as 10- and 90-day globals. Inappropriate valuations of these services has a major effect on the fee schedule due to the percentage of PFS dollars paid through 10- and 90-day global codes (3 percent and 11 percent, respectively), and thus, valuing them appropriately is critical to appropriate valuation and relativity throughout the PFS. Through the individual review approach, we could review the appropriateness of the global period and the accurate number of visits for each service. Yet revaluing all 3,000 global surgery codes through the potentially misvalued codes approach would not address many of the problems identified above. Unless such an effort was combined with changes in the PE methodology, it would only partially address the valuation and accuracy issues and would leave all the other issues unresolved. Moreover, the valuation and accuracy issues that could be addressed through this approach would rapidly be out of date as medical practice continues to change. Therefore, such an approach would be only partially effective and would impede our ability to address other potentially misvalued codes.

    We sought stakeholder input on an accurate and efficient means to revalue or adjust the work RVUs for the current 10- and 90-day global codes to reflect the typical resources involved in furnishing the services including both the pre- and post-operative care on the day of the procedure. We believe that collecting data on the number and level of post-operative visits furnished by the practitioner reporting current 10- and 90-day global codes will be important to ensuring work RVU relativity across these services. We also believe that these data will be important to determine the relationship between current work RVUs and current number of post-operative visits, within categories of codes and code families. However, we believe that once we collect those data, there is a wide range of possible approaches to the revaluation of the large number of individual global services, some of which may deviate from current processes like those undertaken by the RUC. To date, the potentially misvalued code initiative has focused on several hundred, generally high-volume codes per year. This proposal requires revaluing a larger number of codes over a shorter period of time and includes many services with relatively low volume in the Medicare population. Given these circumstances, it does not seem practical to survey time and intensity information on each of these procedures. Absent any new survey data regarding the procedures themselves,

    Page 67587

    we believe that data regarding the number and level of post-service office visits can be used in conjunction with other methods of valuation, such as:

    Using the current potentially misvalued code process to identify and value the relatively small number of codes that represent the majority of the volume of services that are currently reported with codes with post-operative periods, and then adjusting the aggregate RVUs to account for the number of visits and using magnitude estimation to value the remaining services in the family.

    Valuing one code within a family through the current valuation process and then using magnitude estimation to value the remaining services in the family.

    Surveying a sample of codes across all procedures to create an index that could be used to value the remaining codes.

    Although we believe these are plausible options for the revaluation of these services, we believed there may be others. Therefore, we sought input on the best approach to achieve this proposed transition from 10- and 90-day, to 0-day global periods, including the timing of the changes, the means for revaluation, and the most effective and least burdensome means to collect objective, representative data regarding the actual number of visits currently furnished in the post-

    operative global periods. We also solicited comment on whether the effective date for the transition to 0-day global periods should be staggered across families of codes or other categories. For example, while we proposed to transition 10-day global periods in 2017 and 90-

    day global periods in 2018, we solicited comment on whether we should consider implementing the transition more or less quickly and over one or several years. We also solicited comment regarding the appropriate valuation of new, revised, or potentially misvalued 10- or 90-day global codes before implementation of this proposal.

    We received many comments regarding the proposed transition to 0-

    day global packages. Many commenters expressed support or opposition to the proposal. Some commenters offered direct responses to the topics for which we specifically sought comment, while others raised questions regarding how the transition would be implemented. In the following paragraphs, we summarize and respond to these comments.

    Comment: Several commenters supported the proposal, including commenters representing several medical specialty societies and several health systems. Many of these commenters agreed with the reasons presented in the proposal. These commenters agreed that the current structure of the global surgery codes prevents CMS from accurately valuing and paying for these services, even if CMS had necessary visit data available. Many commenters agreed that the current arrangement may lead to unwarranted payment disparities and that the current packages have not evolved with changes in practice and because of this, likely provide unreliable building blocks for new payment methodologies.

    In agreeing with the proposal, MedPAC stated that it ``is essential that the individual services that make up a bundle have accurate values and that there is a mechanism to ensure that the services that are part of the bundle are not paid separately (unbundling). Otherwise, the payment rate for the entire bundle will be inaccurate.'' MedPAC urged CMS to finalize this proposal and plan to use the more accurate valuations to create more accurate bundles in the future.

    Response: We appreciate the commenters' support for the proposal, and agree that there are many reasons why the current construction of the global surgery packages is difficult to reconcile with accurate valuation of individual services within the current payment construct of the PFS. We agree that achieving the agency's goal of greater bundling requires accurate valuation of component services in a surgical procedure.

    Comment: Some commenters, including several of those representing specialty societies, urged CMS to postpone finalization of the proposal pending the report of stakeholder efforts to conduct a comprehensive analysis of the effect it would have on the provision of surgical care, surgical patients, and the surgeons who care for them.

    Response: We share stakeholders' concerns regarding the potential impact of the change on Medicare beneficiaries and practitioners. However, based upon our analysis and the information that stakeholders have provided, we believe delaying the proposal to further study the problems is not warranted given the significant concerns that have been raised with the current construction of the global surgery packages. Instead, as we articulated in making the proposal, we anticipate that further analysis by stakeholders will contribute to implementing the transition in a manner that accurately values and pays for PFS services. We believe that accurate valuation of services furnished to Medicare beneficiaries is overwhelmingly in the best interest of both beneficiaries and those who care for them.

    Comment: We received several comments from commenters who opposed our proposal, and in general these commenters shared the concerns of those who urged a delay in finalizing or implementing the proposal. In addition, some commenters who opposed the proposal disputed our contention that the global periods contribute to unwarranted payment disparities, saying that the increased direct and indirect PE and MP RVUs for E/M services furnished in the global surgical post-operative periods accurately account for the increased PE and MP costs of practitioners who furnish these services relative to practitioners who typically furnish separately reportable E/M services.

    Response: Just as we do not agree that we should delay addressing significant problems with valuations while we further study the issues, we do not believe these same issues raised by commenters opposing the proposal are impediments to implementation. The issues relating to valuation of global period E/M services using our PE methodology are just one of several important considerations that led us to propose transforming 10- and 90-day global services to 0-day global packages. We continue to believe the proposed transformation to 0-day global packages is a simple and immediate step to improve the valuation of the various services included in surgical care. However, Medicare remains committed to bundled payment as a mechanism for delivery system reform and we will continue to explore the best way to bundle surgical services, including alternatives to the 0-day global surgical bundle.

    Comment: Many commenters who opposed the proposal addressed valuation problems that would exist if the proposal were implemented. Some stated that, were CMS to finalize the proposal to pay for post-

    surgical E/Ms using the same codes, the PE and MP RVUs for the services would be artificially reduced because the data from other specialties would be incorporated. These commenters suggested CMS should consider how to maintain the current differences in payment for these services even if the proposal were finalized. Some commenters suggested that CMS would need to account for the additional practice expense and malpractice costs for post-operative surgical visits.

    Response: We develop and establish work, PE, and MP RVUs for specific services to reflect the relative resource costs involved in furnishing the typical

    Page 67588

    PFS service. In developing the proposal, we noted that by including a significant number of E/Ms in the global periods for surgical services, the PFS ratesetting methodology distinguishes these services from other E/Ms for purposes of developing PE and MP RVUs, potentially to the advantage of particular specialties with higher PE and MP RVUs. In contrast, the work RVUs for individual, separately billed E/M services furnished, for example, by primary care practitioners are valued more generally as individual services, and values are not maintained separately from the work RVUs for E/Ms furnished by other practitioners. Therefore, we do not agree with commenters that Medicare should establish higher PE and MP values for E/M services furnished in the post-surgical period than for other E/M services.

    Comment: Several commenters suggested that CMS should not use the OIG reports to generalize its concerns about the provision of surgical care, because the OIG reports represent only a small sample of observations of specific procedures and specialties. Other commenters suggested that the OIG methodology might be flawed because, since CMS does not require documentation of post-operative visits, many practitioners may not document such visits in the medical record.

    Response: We do not have any reason to believe that the OIG findings on the global surgical service packages furnished by particular specialties that the OIG reviewed are not generalizable to other global surgery services. Nor did the commenters provide any evidence that the OIG conclusions are likely to be less accurate than the survey estimates that CMS uses to value the services. Finally, having an incorrect number of postoperative visits is only one of the many valuation problems that have been identified for global surgical packages. Additionally, we find the suggestion that physicians do not document medical visits that are occurring in the post-surgical period to be concerning. As a general matter, Medicare does not require documentation to support a billed service beyond information that the physician would normally maintain in the patient's medical record. Even in the absence of billing Medicare or another insurer, we believe that physicians and other practitioners following standard medical practice would document what occurred during a patient encounter in order to ensure the patient's medical history is accurate and up-to-date, and to facilitate continuity in the patient's medical care.

    Comment: One commenter asserted that the 90-day global period was created to prevent two behaviors referred to as ``fee-splitting'' and ``itinerant surgery.'' According to the commenter, these terms refer to the practice where a surgeon would provide only the surgery and leave postoperative care to other practitioners. The commenter believes these practices are inconsistent with professional standards, and that it is medically necessary and expected by patients that surgeons will evaluate their patients on a daily basis in the hospital and as needed on an outpatient basis during the recovery period.

    Response: We do not believe that the global surgical package was designed to ensure or allocate appropriate post-operative care among practitioners. Under Medicare's current global surgery policy, practitioners can agree on the transfer of care during the global period and, in such cases, modifiers are used in order to split the payment between the procedure and the post-operative care. We do not agree that global surgical packages obligate the surgeon to furnish some or all of the post-operative care. Global surgical packages are valued based on the typical service, and we would not expect every surgery to require the same number of follow-up visits. However, we would expect that over a large number of services, the central tendency would reflect the number of visits we included as typical for purposes of valuing the global package; and as discussed above, we have not found that this is necessarily the case. Even if Medicare maintains the 10- and 90-day global surgery packages, there would be no assurance that the surgeon, and not another practitioner, would furnish all or a certain amount of post-operative care (whether by the patient's choice of practitioner or otherwise). The global payment includes payment for post-operative care with the payment for the surgery, which makes it difficult to know whether or by whom the post-operative care was actually furnished unless there is an official transfer of care. We are confident that the surgical community will continue to furnish appropriate care for Medicare beneficiaries irrespective of changes in the structure of payment for surgical services.

    Comment: Several commenters stated that if Medicare adopts a policy to pay for post-operative care using E/M codes rather than through a global package, Medicare will likely pay a higher level of E/M visits when they are separately billed than it does currently, as the existing global packages tend to include more lower level E/M services than those that are generally reported.

    Response: We acknowledge that the visits assumed in the global packages are generally valued as lower-level visits than are most commonly furnished, as reflected in Medicare utilization data for separately reportable E/Ms. However, this disparity is only pertinent to the proposal if the global packages are inaccurately valued or, if, under the proposed policy, practitioners who furnish these services are likely to inaccurately report the level of E/M service that is actually being furnished. If the former is true, then we believe this supports the proposal to revalue these services. As with every service, we expect physicians to bill the most appropriate E/M codes that reflect the care that is furnished, including for post-operative care.

    Comment: One commenter expressed concern that the proposal to require separate billing for postoperative surgical care provides a basis for the eventual denial of payment to one or more of the postoperative care providers, based on the notion that care furnished by other specialties is duplicative of or replaces care furnished by the surgeon. This commenter stated that multiple providers with differing expertise and training are essential to achieve optimal patient outcomes and expressed concern that this proposal will provide disincentives to optimal patient care.

    Response: As we stated in the proposal, we believe that there are various models for postoperative care that can often include multiple providers, and this is another important reason why we believe the services with longer global periods should be transformed to 0-day packages to accommodate heterogeneous models of care that optimize patient outcomes.

    Comment: One commenter recommended that CMS establish G-codes for three levels of post-operative visits furnished by the original surgeon or another surgeon with the same board certification, as well as a second set of three level G-codes for postoperative visits furnished by another provider. The commenter also suggested that CMS should develop methods to fairly measure the duration of E/M times through which a large sample of surgeons might report the number and intensity of post-

    operative visits. The commenter also recommended that CMS track E/M services furnished to surgical patients within the global period by a physician other than the operating surgeon, for the same or similar diagnosis, in order to begin to understand what portion of

    Page 67589

    postoperative visits are being billed outside of the global period.

    The RUC informed CMS that it has identified several large hospital-

    based physician group practices that internally use CPT code 99024 to report each bundled post-operative visit, and therefore data is already being captured for some Medicare providers. The RUC also suggested that CMS may have denied-claims data available for CPT code 99024 via the Medicare claims processing system. The RUC recommends that CMS work with it to explore the availability, usefulness, and appropriateness of these data from group practices and the CMS denied-claims dataset, in order to gather existing, objective data to validate the actual number of post-operative visits for 10-day and 90-day procedures. The RUC also suggested that CMS should consider reviewing Medicare Part A claims data to determine the length of stay for surgical services furnished in the inpatient acute care hospital setting.

    MedPAC stated that data collection could take several years, would be burdensome for CMS and providers, and may be inaccurate since providers would have little incentive to report each visit. Furthermore, MedPAC suggested that such data collection would be unnecessary since the current ratesetting methodology already assumes particular numbers of visits. MedPAC suggested that CMS should reduce the RVUs for the 10- and 90-day global services based on the same assumptions currently used to pay for these services.

    Several other commenters agreed with the approach advocated by MedPAC (often referred to as ``reverse-building block'') to revaluing the services. These commenters stated that since CMS has increased RVUs for these services proportionate to the number of E/M services assumed to be included in the postoperative period, for the sake of relativity, the RVUs attributed to the visits can be fairly removed in order to value the new 0-day global codes. Many of these commenters acknowledged that this approach would result in negative or other anomalous values for many of these codes, but asserted that codes with anomalous values might then be individually reviewed. MedPAC suggested that if specialty societies or the RUC believe that the new values for specific global codes are inaccurate, they could present evidence that the codes are misvalued to CMS, presumably through the potentially misvalued code public nomination process. MedPAC further states that for codes without accurate post-operative assumptions, CMS could calculate interim RVUs for these codes based on the average percent reduction for other global codes in the same family.

    Many other commenters were against the reverse-building block approach to revaluation. These commenters stated that backing out the bundled E/M services would be highly inappropriate and methodologically unsound since the services were not necessarily valued using a building-block methodology. Many of these commenters, including the RUC, stated that the amount of post-operative work included in the codes can only be appropriately surveyed, vetted, and valued by the RUC.

    Response: We appreciate the concerns of commenters regarding the difficulty of revaluing the global surgery codes as 0-day global packages. As we stated in making the proposal, we believe that such stakeholder input and participation in any revaluation will be critical to the accuracy of the resulting values. We will consider all of these comments as we consider mechanisms for revaluations and as we propose new values for specific services. We believe that the challenges involved in revaluation, such as those articulated by commenters, reinforce our understanding that the current construction of the 10- and 90-day global packages are not a sustainable, long-term approach to the accurate valuation of surgical care. As noted above, we will continue to explore appropriate ways of bundling global surgical services.

    Comment: In general, commenters supporting the proposal also supported CMS's proposed timeframe to transition 10-day global codes and 90-day global codes to 0-day global surgical packages by 2017 and 2018, respectively. In contrast, most commenters objecting to, or articulating reservations about, the proposal urged CMS to slow its implementation. Some of these commenters suggested that the process used to establish the current values for these CPT codes is ideal and stated that it would take many years to value the many individual services using the same methodologies.

    The RUC stated that there are over 4,200 services within the PFS with a 10-day or 90-day global period, so the scope of the proposal is very large and the transition should be staggered over many years. However, the RUC also pointed out that most of these services have relatively low utilization, as only 268 of them (or 6 percent of 10- or 90-day global surgery services) were performed more than 10,000 times annually based on 2013 Medicare claims data.

    Response: We appreciate the concerns of the commenters. We agree with those commenters who urged us to move quickly to value services as accurately as possible. We note that most comments suggesting a delay in revaluation were based on a common underlying view that code-level review of the full set of services by the RUC based on practitioner surveys is the only appropriate way to value the services.

    As we stated in making the proposal, we do not believe that surveying practitioners who furnish each of these services is a practical or necessarily advisable approach to appropriate valuation. Regardless of when the proposal is implemented, it seems likely that the number of codes to be revalued is much larger than the number of codes that should or can be surveyed. Through its normal process, the RUC routinely makes annual recommendations regarding several hundred codes, and we acknowledge that thousands of services cannot be valued using the typical RUC process in one year. On the other hand we believe that there are other options for revaluing some of the global surgery codes as 0-day global packages, particularly those of low volume, and we have indicated a willingness to work with the RUC to determine appropriate mechanisms for revaluations. Therefore, although we agree that revaluing such a high number of codes is a significant undertaking, we do not believe that that the required revaluations would represent an undue burden between the present and the proposed implementation dates. We also note that in order to focus efforts on revaluing the global surgery packages, we are not asking the RUC to review the nearly 100 services we proposed as potentially misvalued this year under the high expenditure screen. We continue to remain interested in other potential data sources for accurately valuing PFS services, especially the vast majority of 10- and 90-day global codes for which there is not significant volume. We also urge stakeholders to engage with us to help us understand why alternative approaches to the revaluation of the 10- and 90-day global services would require the kind of delay that was urged based on the assumption that the RUC survey approach would be used for all those services.

    Additionally, we request stakeholders, including the CPT Editorial Panel and the RUC, to consider the utility of establishing and maintaining separate coding and national Medicare RVUs for the many procedures that have little to no utilization in the Medicare population. For example, there are over 1,000 10-

    Page 67590

    and 90-day global codes with fewer than 100 annual services in the Medicare database. Although we recognize that some portion of these services may be utilized more extensively by non-Medicare payers, it is also likely that many of these codes may reasonably be consolidated. We request that appropriate coding for surgical services be considered as part of revaluing global surgery.

    Comment: Many commenters expressed concerns that requiring beneficiary coinsurance for each follow-up visit could dissuade beneficiaries from returning for necessary follow-up care and, therefore, adversely affect surgical outcomes. Many of these commenters acknowledged that overall patient liability for the total amount of care could be reduced, depending on revaluation, but stated that paying separate coinsurance for follow-up care can cause patients to perceive the net payments as larger, given the frequency of payment required. These commenters stated that the magnitude of these problems might be directly proportionate to how sick the patient is.

    Response: We understand the concerns of the commenters, but do not agree that Medicare beneficiaries are unlikely to appreciate the difference between frequency of payment and overall financial liability. We also note that the significant majority of patient encounters with Medicare practitioners generate some degree of beneficiary liability. While liability could prompt the proportion of beneficiaries without secondary insurance to forgo medically reasonable and necessary care for the treatment of illness or injury, we have no reason to conclude that this would be the case specifically for post-

    operative care. We do acknowledge that surgeons may need to explain the importance of follow-up care so that patients understand and appreciate how compliance with follow-up care can improve the overall quality of care and outcomes. As noted above, while our proposal is to move to 0-

    day global packages as a simple, immediate adjustment, the agency remains committed to bundling as a key component of payment system delivery reform, and we will consider beneficiary impact as we further consider the appropriate size and construction of a surgical bundle.

    Comment: Several commenters expressed concerns that the proposal would result in disjointed or inadequate care and/or disrupt surgical registry data. These commenters suggested that neither patients nor alternate providers are as qualified to determine whether or not a postoperative visit by the surgeon is necessary.

    Response: As discussed above, we do not agree that patients who require the post-operative care of a surgeon are likely to forgo such care if Medicare changes how we pay the surgeon for furnishing that care. Although several commenters expressed these and similar kinds of concerns, none explained how the proposed change in payment would change post operative care. We continue to believe that surgeons will continue to furnish appropriate post operative care to Medicare beneficiaries, and we do not agree that concerns about increased patient liability or disjointed care are warranted.

    Comment: Several commenters expressed concerns over other Medicare payment policies related to surgical procedures. Some commenters stated that the current multiple procedure payment reduction policies that apply to all 0-, 10-, and 90-day global codes are only appropriate for 10-day and 90-day globals due to the overlap in resource costs during the post-operative period. Other commenters noted that potential reductions in payment to surgeons to account for the reduced post-

    operative period would negatively impact practitioners who assist at surgery despite the fact that their professional work and responsibilities have not changed.

    Response: We appreciate the issues raised by these commenters. Again, we seek continued input from the stakeholder community regarding these and other issues that need to be considered in order to implement the transition. In the case of the MPPR, we note there are several hundred 0-day global codes where these payment policies currently apply. We are especially interested in understanding why stakeholders do not believe the policies effective for the current 0-day global codes would not similarly be appropriate for the current 10-and 90-day codes that will be revalued as 0-day global codes.

    Comment: Many of the commenters who opposed or expressed concern about the proposal urged CMS to consider the extent to which this proposal would increase the administrative burden on CMS, MACs, and providers. Other commenters urged CMS to consider that post-operative visits would be subject to the same documentation requirements and other scrutiny as other separately-reportable PFS services. One commenter representing other payers opposed the proposal due to concerns about predicting the usage of post-operative services.

    Response: We considered the administrative burden on both CMS and practitioners who furnish these services in making the proposal. In both cases, we note the administrative burden would be no greater than the burden associated with the vast majority of other services paid through the Medicare PFS. We do not believe that the burden of separately reporting post-operative follow-up visits is particularly or unduly burdensome, given that most office visits paid through the PFS are separately reported under current Medicare policies. In comparison to the number of separately reported visits and other PFS services, the number of visits that likely occur in post-operative periods is relatively small. We do not agree that there are inherent reasons that medically necessary post-operative visits should be exempt from the same documentation and other requirements applicable to other PFS services. We appreciate that changes in Medicare policy may affect other insurers who choose to base their payments on the PFS; however, it is our obligation to set our policies based upon the needs of Medicare and its beneficiaries.

    Comment: A few commenters urged CMS to consider the possibility that there could be confusion among practitioners and payers if some payers continue to base payment on the 10- or 90-day post-operative periods.

    Response: We believe that payment policies that are appropriate for Medicare may not always be optimal for all payers. However, we seek continued input and analysis from other payers as we engage stakeholders in developing our implementation strategy for the transition of 10- and 90-day global services to 0-day global services.

    Comment: Several commenters urged CMS to consult with stakeholders as we develop appropriate plans for the global period transition. These commenters cautioned that the structural reorganization of these services is challenging due to the large set of services that will be impacted and could potentially disrupt well-established payment for certain providers.

    Response: We appreciate these recommendations and agree that we should continue to consult with stakeholders regarding the implementation of this proposal.

    After consideration of all the comments received regarding this proposal, we are finalizing the proposal to transition and revalue all 10- and 90-day global surgery services with 0-day global periods, beginning with the 10-day global services in CY 2017 and following with the 90-day global services in CY 2018. We note that as we

    Page 67591

    develop implementation details, including revaluations, we will take into consideration all of the comments we received to our global surgery proposal. We will provide additional details during the CY 2016 rulemaking. We are finalizing a transformation to 0-day global codes because we believe this is the most straightforward way to improve the accuracy of valuation for the various components of global surgical packages, including pre- and post-operative visits and performance of the surgical procedure. However, we remain committed to delivery system reform and ensuring Medicare makes appropriate payment for bundles of services whether our payment covers a period of 0, 10 or 90 days. As we begin revaluation of services as 0-day globals, we will actively assess whether there is a better construction of a bundled payment for surgical services.

    We also actively seek the analysis and perspective of all affected stakeholders regarding the best means to revalue these services as 0-

    day global codes. We urge all stakeholders to engage with us regarding potential means of making the transition as seamless as possible, both for patient care and provider impact. We are considering a wide range of approaches to all details of implementation from revaluation to communication and transition, and we are hopeful that sufficient agreement can be reached among stakeholders on important issues such as revaluation of the global services and appropriate coding for post-

    operative care. We remain committed to collecting objective data regarding the number of visits typically furnished during post-

    operative periods and will explore the extant source options presented by commenters as we consider other options as well.

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

    The CPT manual includes more than 300 diagnostic and therapeutic procedures, listed in Appendix G, for which CPT has determined that moderate sedation is an inherent part of furnishing the procedure and, therefore, only the single procedure code is appropriately reported when furnishing the service and the moderate sedation. The work of moderate sedation has been included in the work RVUs for these diagnostic and therapeutic procedures based upon their inclusion in Appendix G. Similarly, the direct PE inputs for these services include those inputs associated with furnishing a typical moderate sedation service. To the extent that moderate sedation is typically furnished as part of the diagnostic or therapeutic service, the inclusion of moderate sedation in the valuation of the procedure is appropriate.

    In the CY 2014 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. For example, one study showed that while the use of a separate anesthesia professional for colonoscopies and upper endoscopies was just 13.5 percent in 2003, the rate more than doubled to 30.2 percent in 2009. An analysis of Medicare claims data showed that a similar pattern is occurring in the Medicare program. We found that, for certain types of procedures such as digestive surgical procedures, a separate anesthesia service is furnished 53 percent of the time. For some of these digestive surgical procedures, the claims analysis showed that this rate was as high as 80 percent.

    Our data clearly indicated that moderate sedation was no longer typical for all of the procedures listed in CPT's Appendix G, and, in fact, the data suggested that the percent of cases in which it is used is declining. For many of these procedures in Appendix G, moderate sedation continued to be furnished. The trend away from the use of moderate sedation toward a separately billed anesthesia service was not universal. We found that it differed by the class of procedures, sometimes at the procedure code level, and continued to evolve over time. Due to the changing nature of medical practice in this area, we noted that we were considering establishing a uniform approach to valuation for all Appendix G services for which moderate sedation is no longer inherent, rather than addressing this issue at the procedure level as individual procedures are revalued.

    We sought public comment on approaches to address the appropriate valuation of these services. Specifically, we were interested in approaches to valuing Appendix G codes that would allow Medicare to pay accurately for moderate sedation when it is furnished while avoiding potential duplicative payments when separate anesthesia is furnished and billed. 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.

    We noted that in the CY 2014 PFS final rule with comment period, we established values for many upper gastrointestinal procedures, 58 of which were included in Appendix G. For those interim final values, we included the inputs related to moderate sedation. We stated that we did not expect to change existing policies for valuing moderate sedation as inherent in these procedures until we have the opportunity to assess and respond to the comments on the proposed rule on the overall valuation of Appendix G codes.

    We received many helpful suggestions in response to our comment solicitation. At this time, we are not making any changes to how we value Appendix G codes for which moderate sedation is an inherent part of the procedure. We intend to address this topic in future notice and comment rulemaking, taking into account the comments we received. In section II.G. of this CY 2015 PFS final rule with comment period, we address interim final values and establish CY 2015 inputs for the lower gastrointestinal procedures, many of which are also listed in Appendix G.

    1. 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) of the Act, beginning in CY 2000, MP RVUs are resource based. Malpractice RVUs for new codes after 1991 were 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. For CY 2015, we are proposing to implement the third comprehensive review and update of MP RVUs. For details about prior updates, see the CY 2010 final rule with comment period (74 FR 33537).

      2. Methodology for the Proposed Revision of Resource-Based Malpractice RVUs

      The proposed MP RVUs were calculated by a CMS contractor based on updated MP premium data obtained from state insurance rate filings. The methodology used in calculating the proposed CY 2015 review and update of resource-based MP RVUs largely paralleled the process used in the CY 2010 update. The calculation required using information on specialty-

      specific MP premiums linked to a specific service based upon the relative risk factors of the various specialties that furnish a particular service. Because MP premiums vary by state and specialty,

      Page 67592

      the MP premium information were weighted geographically and by specialty. Accordingly, the proposed MP RVUs were based upon three data sources: CY 2011 and CY 2012 MP premium data; CY 2013 Medicare payment and utilization data; and CY 2015 proposed work RVUs and geographic practice cost indices (GPCIs).

      Similar to the previous update, we calculated the proposed MP RVUs using specialty-specific MP premium data because they represent the actual expense incurred by practitioners to obtain MP insurance. We obtained and used MP premium data from state departments of insurance rate filings, primarily for physicians and surgeons. When the state insurance departments did not provide data, we used state rate filing data from the Perr and Knight database, which derives its data from state insurance departments. We used information obtained from MP insurance rate filings with effective dates in 2011 and 2012. These were the most current data available during our data collection process.

      We collected MP insurance premium data from all 50 States, the District of Columbia, and Puerto Rico. Rate filings were not available in American Samoa, Guam, or the Virgin Islands. Premiums were for $1 million/$3 million, mature, claims-made policies (policies covering claims made, rather than those covering services furnished, during the policy term). A $1 million/$3 million liability limit policy means that the most that would be paid on any claim is $1 million and the most that the policy would pay for claims over the timeframe of the policy is $3 million. We made adjustments to the premium data to reflect mandatory surcharges for patient compensation funds (funds to pay for any claim beyond the statutory amount, thereby limiting an individual physician's liability in cases of a large suit) in states where participation in such funds is mandatory. We attempted to collect premium data representing at least 50 percent of the medical MP premiums paid.

      We included premium information for all physician and NPP specialties, and all risk classifications available in the collected rate filings. Most insurance companies provided crosswalks from insurance service office (ISO) codes to named specialties. We matched these crosswalks to Medicare primary specialty designations (specialty codes). We also used information we obtained regarding surgical and nonsurgical classes. Some companies provided additional surgical subclasses; for example, distinguishing family practice physicians who furnish obstetric services from those who do not.

      Although we collected premium data from all states and the District of Columbia, not all specialties had premium data in the rate filings from all states. Additionally, for some specialties, MP premiums were not available from the rate filings in any state. Therefore, for specialties for which there was not premium data for at least 35 states, and specialties for which there was not distinct premium data in the rate filings, we crosswalked the specialty to a similar specialty, conceptually or by available premium data, for which we did have sufficient and reliable data. Additionally, we crosswalked three specialties--physician assistant, registered dietitian and optometry--

      for which we had data from at least 35 states to a similar specialty type because the available data contained such extreme variations in premium amounts that we found it to be unreliable. The range in premium amounts for registered dietitians is $85 to $20,813 (24,259 percent), for physician assistants is $614 to $35,404 (5,665 percent), and for optometry is $189 to $10,798 (5,614 percent). We crosswalked these specialties to allergy and immunology, the specialty with the lowest premiums for which we had sufficient and reliable data.

      Our proposed methodology for updating the MP RVUs conceptually followed the specialty-weighted approach, used in the CY 2010 update. The specialty-weighted approach bases the MP RVUs for a given service upon a weighted average of the risk factors of all specialties furnishing the service. This approach ensures that all specialties furnishing a given service are accounted for in the calculation of the MP RVUs. We also continued to use the risk factor of the dominant specialty for rarely billed services (that is, when CY 2013 claims data reflected allowed services of less than 100).

      We proposed minor refinements for updating the CY 2015 MP RVUs as compared to the previous update. These refinements included calculating a combined national average surgical premium and risk factor for neurosurgery and neurology and updating the list of invasive cardiology service HCPCS codes (for example, cardiac catheterization and angioplasty) to be classified as surgery for purposes of assigning service level risk factors. Additionally, we proposed to classify injection procedures used in conjunction with cardiac catheterization as surgery (for purposes of assigning a service specific risk factor). To calculate the risk factor for TC services we proposed to use the mean umbrella non-physician MP premiums obtained from Radiology Business Management Association (RBMA) survey data, used for the previous MP RVU update in 2010, and adjusted the premium data to reflect the change in non-surgical premiums for all specialties since the previous MP RVU update.

      As discussed in the CY 2015 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 intend to propose an anesthesia adjustment for MP in the CY 2016 PFS proposed rule. We also requested comments on how to reflect updated MP premium amounts under the anesthesiology fee schedule.

      We posted our contractors report, ``Report on the CY 2105 Update of Malpractice RVUs'' on the CMS Web site. The report on MP RVUs for the CY 2015 proposed rule and the proposed MP premium amounts and specialty risk factors are accessible from the CMS Web site under the supporting documents section of the CY 2015 PFS proposed rule at http://www.cms.gov/PhysicianFeeSched/. A more detailed explanation of our proposed MP RVU update can be found in the CY 2015 PFS proposed rule (79 FR 40349 through 40355).

      3. Response to Public Comments

      We received over 70 industry comments on the CY 2015 proposed MP RVU update. A summary of the comments we received on the proposed MP RVU update and our responses are discussed below.

      Comment: Two commenters supported our proposal to combine the surgical premium data for neurosurgery and neurology for establishing the surgical risk factor for neurosurgery.

      Response: We agree with the commenters and will finalize our approach for determining the surgical premium for neurosurgery as proposed. We will combine surgical premiums for neurology and neurosurgery to calculate a national average surgical premium and risk factor for neurosurgery.

      Comment: Three commenters requested that we phase in the reduction for ophthalmology and optometry services over 2 years. The commenters stated that the reduction is due in part to an error we made in calculating the MP RVUs for ophthalmology and optometry codes under the previous MP RVU update in CY 2010. The commenters stated that an immediate implementation of the correction would result in significant

      Page 67593

      payment reductions for ophthalmologists.

      Response: We note that for the CY 2015 MP RVU update we did not correct the mistake that was made in CY 2010. For the CY 2015 MP update we recalculated the MP RVUs based upon the most recently available data for all services, including ophthalmic services. Accordingly, the proposed MP RVU update reflects the use of updated MP premium data and risk factors by specialty and is not affected in any way by the CY 2010 MP RVUs. In doing so, even though the proposed CY 2015 ophthalmology non-surgical risk factor was 14 percent greater than the CY 2010 non-

      surgical risk factor and the proposed surgical risk factor was 17 percent greater, the proposed MP RVUs for most services with significant ophthalmology volume decreased because the CY 2010 error resulted in MP RVUs that were higher than they should have been. That is, the reduction in MP RVUs for ophthalmology and optometry are solely due to overpayments made due to a mistake during the previous MP RVU update rather than a proposed change in methodology or the use of updated premium data. We do not believe that a previous error is sufficient justification for not fully implementing updated MP RVUs based on more recent premium data. Therefore, we will implement the updated MP RVUs for ophthalmology and optometry services as proposed.

      Comment: We received comments regarding the application of our specialty weighted approach for calculating service level risk factors for surgical services. For instance, the same commenters that requested a 2-year phase in of the reduction to ophthalmology services also requested that we exclude optometry from calculating the risk factor for ophthalmic surgery. One commenter stated that ``MP RVUs for cataract and other ophthalmic surgeries are deflated because CMS assumes that optometry is providing the surgical portion of the procedure.'' The commenter also stated that optometrists are involved only during the pre- or post-procedure periods of ophthalmic surgery. Another specialty society stated that it appears that CMS's methodology for calculating service level risk factors for surgical services ``may include the allowed services for surgical assistance possibly discounted to reflect the assistant role under payment policy.'' The commenter also stated that ``specialties that assist at the procedure do not perform it, and the assistant's associated MP risk factor has no bearing on the MP cost for the surgeon.''

      Response: The commenter is correct to say that we calculated service level risk factors based on the mix of all practitioners billing for a given service and that the specialty weighted approach is applied to both surgical and non-surgical services . That is, we apply the risk factor(s) of all specialties involved with furnishing the surgical procedure to calculate service level risk factors and MP RVUs. For assistants at surgery, we discount the utilization to reflect his or her role in furnishing the surgical procedure. Although we agree that MP cost for the surgeon may not be affected by the surgical assistant's MP cost, we do not agree with the suggestion that assistants at surgery should be excluded from our specialty weighted approach for determining service level MP risk factors and MP RVUs for surgical services. We believe it is appropriate to apply the specialty risk factor(s) of all practitioners participating in and receiving a payment for the surgical procedure for purposes of determining a service level risk factor and thus the payment for that service. If we were to exclude the risk factors of some specialties that bill a specific code from the calculation of the service level risk factor, the resulting MP RVU would not reflect all utilization. Similarly, we also disagree with the suggestion that pre- and post- utilization should be removed from determining MP RVUs for ophthalmic surgical services. The resources associated with pre- and post-operative periods for ophthalmic surgery are included in the total RVUs for the global surgical package. Accordingly, if we did not include the portion of utilization attributed to pre- and post-operative visits in the calculation of service level risk factors, the MP RVUs for global surgery would overstate the MP costs.

      We note that in both of these cases by using the discounted utilization file the weighted average that we use reflects only the proportion of the utilization by these practitioners and only at the payment rate made. Including specialty utilization for all practitioners involved in furnishing the global service reflects the MP risk for the entire global service.

      Comment: We received two comments regarding how risk factors are assigned to existing services without Medicare utilization. The commenters stated that we crosswalk to the risk factor of an analogous source code with Medicare utilization for new codes but assign the average risk factor for all physicians to existing services without Medicare utilization. The commenters contend that ``it is inappropriate for a service to have fluctuating MP risk factors simply due to whether it is reported in Medicare claims data for a given year.'' The commenters requested that we crosswalk existing services without Medicare utilization to a recommended source code.

      Response: We used the most recently available Medicare claims data (that is, from CY 2013) to determine the service level risk factors, either based on the risk factors of the actual mix of practitioners furnishing the service, or in the case of low volume services, the risk factor of the dominant specialty. We disagree with the commenters' suggestion to assign the risk factor of a recommended specialty to an existing service without Medicare utilization as indicated by our most recently available claims data. In the absence of Medicare utilization we continue to believe that the most appropriate risk factor is the weighted average risk factor for all service codes. The proposed weighted average risk factor for all service codes was 2.11. Using the weighted average risk factor for all services effectively neutralizes the impact of updated MP premiums and risk factors for any specific specialty (or mix of specialties).

      Comment: The AMA and the RUC and other commenters agreed with the majority of our proposed claims based dominant specialty designations for codes with less than 100 allowed services; however, the commenters disagreed with our proposed dominant specialty for some services. The commenters believe that some claims have been miscoded, resulting in erroneous specialty designations. One commenter stated that using the dominant specialty from the claims data resulted in unjustifiably low MP RVUs for congenital heart surgery. The commenter stated that congenital heart surgery can only be done by a heart surgeon and requested that we override the dominant specialty in our claims data and use the RUCs recommended specialty.

      Response: As discussed in the previous response, we proposed to use CY 2013 claims data to determine the service level MP risk factors, either based on the mix of practitioners furnishing the service, or in the case of low volume services, assigning the risk factor of the dominant specialty. We continue to believe that use of actual claims data to determine the dominant specialty is preferable to using a ``recommended'' specialty. However, we recognize that anomalies in the claims data can occur that would affect the dominant specialty for low volume services, and therefore resulting in the need for a subjective review of some services in place of a complete reliance on claims data. To that end, we

      Page 67594

      reviewed the commenter's recommendations for overriding the dominant specialty from our claims data with a recommended specialty. After careful consideration of the comments, we will override the dominant specialty from Medicare claims data when the dominant specialty from our claims data is inconsistent with a specialty that could be reasonably expected to furnish the service. For example, our claims data indicates that pulmonary disease is the dominant specialty for HCPCS code 33622 (Reconstruction of complex cardiac anomaly), however as the commenter mentioned, this service is furnished by heart surgeons. A complete listing of low volume services for which we will override the claims based dominant specialty with the recommended specialty to assign a service level risk factor is illustrated in Table 12.

      Table 12--Low Volume Service Codes Where Assigned Specialty Used Rather Than Claims Based Dominant Specialty

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

      Claims based dominant

      HCPCS Code Short descriptor specialty Assigned specialty

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

      25490................................ Reinforce radius....... Otolaryngology......... Orthopedic Surgery.

      26556................................ Toe joint transfer..... Pulmonary Disease...... Orthopedic Surgery.

      31320................................ Diagnostic incision Cardiology............. Otolaryngology.

      larynx.

      33620................................ Apply r&l pulm art Anesthesiology......... Cardiac Surgery.

      bands.

      33621................................ Transthor cath for Cardiology............. Cardiac Surgery.

      stent.

      33622................................ Redo compl cardiac Pulmonary Disease...... Cardiac Surgery.

      anomaly.

      33697................................ Repair of heart defects Cardiology............. Cardiac Surgery.

      33766................................ Major vessel shunt..... General Surgery........ Cardiac Surgery.

      36261................................ Revision of infusion General Practice....... General Surgery.

      pump.

      43341................................ Fuse esophagus & Gastroenterology....... Thoracic Surgery.

      intestine.

      43350................................ Surgical opening General Practice....... General Surgery.

      esophagus.

      49491................................ Rpr hern preemie reduc. General Practice....... General Surgery.

      50686................................ Measure ureter pressure Internal Medicine...... Urology.

      54352................................ Reconstruct urethra/ Pediatric Medicine..... Urology.

      penis.

      54380................................ Repair penis........... Gastroenterology....... Urology.

      61000................................ Remove cranial cavity Family Practice........ Neurosurgery.

      fluid.

      61558................................ Excision of skull/ Family Practice........ Neurosurgery.

      sutures.

      61567................................ Incision of brain Cardiology............. Neurosurgery.

      tissue.

      74710................................ X-ray measurement of Thoracic Surgery....... Diagnostic Radiology.

      pelvis.

      96003................................ Dynamic fine wire emg.. Cardiology............. Physical Therapist/

      Independent Practice.

      96420................................ Chemo ia push technique Urology................ Hematology Oncology.

      99170................................ Anogenital exam child w Ophthalmology.......... Pediatric Medicine.

      imag.

      99461................................ Init nb em per day non- Cardiac Pediatric Medicine.

      fac. Electrophysiology.

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

      Comment: Some commenters requested that we crosswalk gynecological oncology to general surgery, instead of crosswalking to obstetrics/

      gynecology because gynecological oncology is more akin to general surgery procedures than obstetrics/gynecology. One specialty society stated that gynecological oncologists are predominantly cancer surgeons with MP risk similar to general surgery.

      Response: We agree with the commenters and will crosswalk gynecological oncology to the general surgery premium data and risk factor.

      Comment: One commenter requested that we crosswalk clinical laboratory to pathology instead of the risk factor used for TC services because clinical laboratories and pathologists render essentially identical medical procedures that are paid on the Medicare PFS.

      Response: We believe that the MP risk for clinical laboratories is more akin to the MP risk of radiation therapy centers, mammography screening centers and IDTFs, for which we assigned the TC risk factor, than to the MP risks for pathologists. The commenters did not provide sufficient rationale to support that MP risk for clinical laboratories is similar to the MP risk of pathologists. Therefore, we will crosswalk clinical laboratory to the TC risk factor as proposed.

      Comment: One commenter encouraged us to crosswalk the interventional pain management specialty to a specialty that more closely reflects the risks and services associated with interventional pain management, such as interventional radiology or a comparable surgical subspecialty.

      Response: We believe that the MP risk associated with interventional pain management is conceptually similar to the MP risk for anesthesiology more so than to the MP risk for interventional radiology. Given that the commenters did not provide sufficient rationale to support that MP risk for interventional pain management is similar to interventional radiology or to a comparable surgical specialty, we will crosswalk interventional pain management to anesthesiology as proposed.

      Comment: We received contrasting comments on our proposal to crosswalk NPPs to the premium and risk factor calculated for allergy/

      immunology. For instance, one commenter acknowledged the difficulty in identifying comprehensive, accurate premium data across the majority of states, especially for NPPs. To that end, the commenter supported our decision to crosswalk the MP premiums of NPPs to the lowest physician risk factor, allergy/immunology. Another commenter, specifically supported crosswalking registered dieticians to the risk factor calculated for allergy/immunology.

      In contrast, the AMA and other commenters did not support crosswalking NPPs with insufficient or unreliable premium data to the premium amounts and risk factor used for allergy/immunology. The commenters stated that allergy/immunology premiums overstate NPP premiums and requested that we use the generally lower MP survey data from the Physician Practice Information Survey (PPIS) for NPPs instead of crosswalking NPPs to the lowest physician specialty (allergy/

      immunology) or use some other measure of central tendency within the existing collected premium data to determine accurate MP premium risk factors for NPPs. Another commenter suggested that we work with the AMA

      Page 67595

      to obtain the necessary data to ensure the process for reviewing and updating MP rates is accurate for all providers.

      Response: As discussed previously in this section, the resource-

      based MP RVUs are based on verifiable MP premium data. We do not believe it would be appropriate to base the MP RVUs for nonphysician specialties on survey data and use premium data for all other specialties. Therefore, we do not agree with the commenters that suggested using survey data for NPPs and will finalize the specialty crosswalks for NPPs as proposed. However, in light of the commenter's suggestions, we will explore ways to enhance our MP premium data collection efforts to obtain better premium data for NPPs for future updates. We will also explore other potential measures of central tendency for determining the ``indexed'' specialty as an alternative to using the premium values of the lowest specialty.

      Comment: We received two comments regarding the data and or methodology used to calculate the TC and PC of diagnostic services. One specialty group noted that the proposed MP RVUs for the TC of some diagnostic services increased while the MP RVUs for the PC decreased. Specifically, the commenter questioned why the MP RVUs for the PC of diagnostic cardiac catheterization as described by HCPCS codes 93451 through 93461 decreased by 6 to 12 percent while the TC portion for these codes increased by 20 to 33 percent. The commenter encouraged us to review the reasons for this shift to TC MP RVUs. Additionally, the RBMA submitted updated MP premium information collected from IDTFs in 2014. The RBMA requested that we use the recently obtained data reflecting the median ``50th percentile'' premium data for ``umbrella non-physician MP liability'' for calculating CY 2015 MP RVUs for TC services.

      Response: To calculate the risk factor for TC services we used the mean umbrella non-physician MP premiums obtained from the RBMA survey data (used for the previous MP RVU update in 2010) and adjusted the data to reflect the change in non-surgical premiums for all specialties since the previous MP RVU update, for example, $9,374 deflated by -

      20.41 percent = $7,455. However, given that the premiums of the lowest physician specialty (allergy/immunology) decreased by more than 20 percent, the proposed CY 2015 risk factor for TC services increased from the previous update in CY 2010 from 0.86 to 0.91, resulting in minor increases in MP RVUs for TC services. However, given that the MP RVUs for TC services are generally low, any increase to the MP RVUs could result in a significant percentage increase. For example, the proposed CY 2015 MP RVU for HCPCS code 93455 increased from 0.04 to 0.05 yielding a 25 percent increase. Therefore, a minor increase in MP RVUs for a TC service could result in a significant percentage change.

      We believe that using the updated RBMA premium data without further study is problematic because the updated data reflects only the median umbrella non-physician MP premium, rather than the mean as was used for the 2010 MP RVU update and the proposed 2015 MP RVU update.

      We believe further study is necessary to reconcile comments on the use of updated RBMA premium data for TC services (which would result in an increase MP RVU for TC services) and our current methodology for calculating the risk factor for PC services relative to the global service and TC service. Therefore, we will finalize the TC premium data as proposed and maintain our current methodology for calculating the PC risk factor. We will consider the request to use the updated premium information from RBMA and alternatives to our current methodology for calculating the PC risk factor as part of our further study and would propose any changes through future rulemaking.

      Comment: Several commenters supported our proposal to classify cardiac catheterization and angioplasty services as surgical procedures for the purpose of establishing service level risk factors. The commenters also agreed with our proposal to apply the surgical risk factor to injection procedures used in conjunction with cardiac catheterization. The same commenters identified additional cardiac catheterization and angioplasty services that were not included on the proposed list of invasive cardiology services. Specifically, the commenters requested that we consider adding HCPCS codes 92961, 92986, 92987, 92990, 92992, 92993, 92997, and 92998 to the list of invasive cardiology procedures classified as surgery for purposes of assigning service level risk factors because the MP risk for these services is similar to surgery.

      Response: We agree that the MP risk associated with the cardiac catheterization and angioplasty services mentioned by the commenters are more akin to surgical procedures than most non-surgical services. Therefore, we will add cardiac catheterization and angioplasty services as described by HCPCS codes 92961, 92986, 92987, 92990, 92997, and 92998 to the list of services outside of the surgical HCPCS code range to be considered surgery for purposes of assigning service level MP risk factors. We note that HCPCS codes 92992 and 92993 are contractor-

      priced codes, wherein the Medicare claims processing contractors establish RVUs and payment amounts for these services. Therefore, we are not adding HCPCS codes 92992 and 92993.

      Comment: One commenter stated that several injection codes were not included in the list of services outside of the surgical HCPCS code range considered surgery. The commenter requested that we add injection services as described by HCPCS codes 93565, 93566, 93567, and 93568 to the services considered as surgery.

      Response: The commenter is mistaken. As discussed in the CY 2015 proposed rule (79 FR 40353 through 40354), we included the injection procedure codes mentioned by the commenter on the list of services outside of the surgical HCPCS code range to be considered surgery for purposes of assigning service level MP risk factors.

      Comment: One commenter questioned why the MP RVUs decrease for cardiac catheterization services as described by HCPCS codes 93530, 93531 and 93580. The commenter stated that our proposal to assign the surgical risk factor to invasive cardiology services outside of the surgical HCPCS code range should result in an increase in MP RVUs.

      Response: Cardiac catheterizations as described by HCPCS codes 93530, 93531 and 93580 are currently on the list of invasive cardiology services classified as surgery for purposes of assigning service level risk factors. Therefore, the MP RVUs for HCPCS codes 93530, 93531, 93580 were calculated in the last update using the surgical risk factor applicable to the specialty(s) furnishing these services. As discussed previously in this section, the service level risk factors reflect the average risk factor (weighted by allowed services) of the specialties furnishing a given service. Changes in the specialty mix since the previous MP RVU update in 2010 resulted in a decrease in MP RVUs for HCPCS codes 93530, 93531, and 93580. That is, the percentage of allowed services attributed to cardiology decreased for these service codes while the percentage of allowed services furnished by other specialties with risk factors lower than cardiology, such as internal medicine and pediatric medicine, increased.

      Comment: Many commenters requested an explanation as to why the MP RVUs decreased for 4 out of the 6 newly bundled image guided breast biopsy procedures. The commenters

      Page 67596

      stated that given that the MP RVUs assigned to breast biopsy codes are being reduced, CMS is not appropriately capturing the risk a physician assumes when performing a procedure to diagnose cancer. Several commenters also explained that the misdiagnosis of breast cancer is a leading source of MP litigation and that reduction in payment for breast biopsies will have an impact on patient care.

      Response: For the image guided breast biopsy procedures as described by HCPCS codes 19081 through 19086, we used the risk factors from source codes as recommended by the RUC. The source codes for breast biopsy codes 19081, 19082, 19083, 19084, 19085 and 19086 are HCPCS codes 32553, 64480, 32551, 64480, 36565, and 76812, respectively. Given that the proposed risk factors for HCPCS codes 32553, 64480, and 32551 decreased from 2014 to 2015, the corresponding ``destination'' service codes, that is HCPCS codes 19081, 19082, 19083, and 19084 also decreased.

      Comment: Several commenters recommended that we implement an annual collection and review of MP premium data and rescale the MP RVUs each year, as we do with the PE RVUs. The commenters also stated that an annual update would provide additional transparency and allow stakeholders to identify potential problems and or improvements to MP RVUs more frequently.

      Response: We appreciate the comments from stakeholders regarding the frequency that we currently review changes in MP premium data. As discussed in the CY 2015 PFS proposed rule (79 FR 40349 through 40355), there are two main aspects to the update of MP RVUs, recalculation of specialty risk factors based upon updated premium data and recalculation of service level RVUs based upon the mix of practitioners providing the service. We will consider the recommendation from stakeholders to conduct annual MP RVU updates to reflect corrections and changes in the mix of practitioners providing services. We will also consider the appropriate frequency for collecting new MP premium data. After reviewing these issues, we would address potential changes regarding the frequency of MP RVU updates in a future proposed rule.

      Comment: One commenter urged us to calculate risk factors for all specialties approved by the American Board Medical Specialties (ABMS) since 2010. The commenter stated that by using the approved ABMS specialties, all specialties and subspecialties will be represented, including the recently approved sub-specialty of Female Pelvic Medicine and Reconstructive Surgery.

      Response: We calculate service level risk factors based on the mix of specialties that furnish a given service as indicated by our claims data. Medicare claims data reflects the service volume by Medicare primary specialty designations. Therefore, we can only use MP risk factors by Medicare primary specialty codes.

      Comment: We received two comments regarding our discussion of how to reflect updated MP premium data under the anesthesiology fee schedule. One commenter supported our decision to delay the anesthesia MP update and requested to work with us on developing an appropriate method for updating the MP component associated with anesthesia fee schedule services. 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. The commenter stated that the calculation of premiums over a longer period of time renders the average more accurate and less volatile than a calculation over a 1-year period.

      Response: We appreciate the comments on our potential approach for updating the MP resource costs for anesthesia fee schedule services. We will consider the commenter's suggestions to use multi-year average premiums as we develop a method for updating MP payments for services paid on the anesthesia fee schedule.

      4. Result of Evaluation of Comments

      After consideration of the public comments received on the CY 2015 MP RVU update, we are finalizing the CY 2015 MP RVU update as proposed with minor modifications. We are crosswalking gynecological oncology to the risk factor for general surgery (instead of the risk factor for obstetrics gynecology). We are also adding HCPCS codes 92961, 92986, 92987, 92990, 92997, and 92998 to the list of services outside of the surgical HCPCS code range considered as surgery for purposes of assigning service level risk factors. Additionally, for determining the risk factor for low volume services, we are overriding the dominant specialty from our claims data with the recommended specialty for the low volume service codes listed in Table 12. For all other low volume services, we are finalizing our proposal to use the risk factor of the dominant specialty from our Medicare claims data. The MP premium amounts, specialty risk factors, and a complete list of service codes outside the surgical HCPCS code range considered surgery for the purpose of assigning service level risk factors, may be found on the CMS Web site under the supporting documents section of the CY 2015 PFS final rule with comment period.

      Additional information on the CY 2015 update may be found in our contractor's report, ``Final Report on the CY 2105 Update of Malpractice RVUs,'' which is available 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/.

    2. Geographic Practice Cost Indices (GPCIs)

      1. Background

      Section 1848(e)(1)(A) of the Act requires us to develop separate Geographic Practice Cost Indices (GPCIs) to measure relative cost differences among localities compared to the national average for each of the three fee schedule components (that is, work, PE, and MP). Although the statute requires that the PE and MP GPCIs reflect the full relative cost differences, section 1848(e)(1)(A)(iii) of the Act requires that the work GPCIs reflect only one-quarter of the relative cost differences compared to the national average. In addition, section 1848(e)(1)(G) of the Act sets a permanent 1.5 work GPCI floor for services furnished in Alaska beginning January 1, 2009, and section 1848(e)(1)(I) of the Act sets a permanent 1.0 PE GPCI floor for services furnished in frontier states (as defined in section 1848(e)(1)(I) of the Act) beginning January 1, 2011. Additionally, section 1848(e)(1)(E) of the Act provided for a 1.0 floor for the work GPCIs, which was set to expire on March 31, 2014. However, section 102 of the PAMA extended application of the 1.0 floor to the work GPCI through March 31, 2015.

      Section 1848(e)(1)(C) of the Act requires us to review and, if necessary, adjust the GPCIs at least every 3 years. Section 1848(e)(1)(C) of the Act requires that ``if more than 1 year has elapsed since the date of the last previous adjustment, the adjustment to be applied in the first year of the next adjustment shall be 1/2 of the adjustment that otherwise would be made.'' We completed a review and finalized updated GPCIs in the CY 2014 PFS final rule with comment period (78 FR 74390). Since the last GPCI update had been implemented over 2 years prior, CY 2011 and CY 2012, we phased in 1/2 of the latest GPCI adjustment in CY 2014. We also revised the cost share

      Page 67597

      weights that correspond to all three GPCIs in the CY 2014 PFS final rule with comment period. We calculated a corresponding geographic adjustment factor (GAF) for each PFS locality. The GAFs are a weighted composite of each area's work, PE and MP GPCIs using the national GPCI cost share weights. Although the GAFs are not used in computing the fee schedule payment for a specific service, we provide them because they are useful in comparing overall areas costs and payments. The actual effect on payment for any actual service will deviate from the GAF to the extent that the proportions of work, PE and MP RVUs for the service differ from those of the GAF.

      As previously noted, section 102 of the PAMA extended the 1.0 work GPCI floor through March 31, 2015. Therefore, the CY 2015 work GPCIs and summarized GAFs were revised to reflect the 1.0 work floor. Additionally, as required by sections 1848(e)(1)(G) and 1848(e)(1)(I) of the Act, the 1.5 work GPCI floor for Alaska and the 1.0 PE GPCI floor for frontier states are permanent, and therefore, applicable in CY 2015.

      Comment: A few commenters requested that we extend the 1.0 work GPCI floor beyond March 31, 2015.

      Response: As discussed in section II.D.1, the 1.0 work GPCI floor is established by statute and expires on March 31, 2015. We do not have authority to extend the 1.0 work GPCI floor beyond March 31, 2015.

      As discussed in the CY 2014 PFS final rule with comment period (78 FR 74380) the updated GPCIs were calculated by a contractor to CMS. We used updated Bureau of Labor and Statistics Occupational Employment Statistics (BLS OES) data (2009 through 2011) as a replacement for 2006 through 2008 data for purposes of calculating the work GPCI and the employee compensation component and purchased services component of the PE GPCI. We also used updated U.S. Census Bureau American Community Survey (ACS) data (2008 through 2010) as a replacement for 2006 through 2008 data for calculating the office rent component of the PE GPCI. To calculate the MP GPCI we used updated malpractice premium data (2011 and 2012) from state departments of insurance as a replacement for 2006 through 2007 premium data. We also noted that we do not adjust the medical equipment, supplies and other miscellaneous expenses component of the PE GPCI because we continue to believe there is a national market for these items such that there is not a significant geographic variation in relative costs. Additionally, we updated the GPCI cost share weights consistent with the modifications made to the 2006-based MEI cost share weights in the CY 2014 final rule with comment period. As discussed in the CY 2014 final rule with comment period, use of the revised GPCI cost share weights changed the weighting of the subcomponents within the PE GPCI (employee wages, office rent, purchased services, and medical equipment and supplies). For a detailed explanation of how the GPCI update was developed, see the CY 2014 final rule with comment period (78 FR 74380 through 74391).

      2. Proposed Changes to the GPCI Values for the Virgin Islands Payment Locality

      As discussed in the CY 2015 proposed rule (79 FR 40355 through 40356) the current methodology for calculating locality level GPCIs relies on the acquisition of county level data (when available). Where data for a specific county are not available, we assign the data from a similar county within the same payment locality. The Virgin Islands have county level equivalents identified as districts. Specifically, the Virgin Islands are divided into 3 districts: Saint Croix; Saint Thomas; and Saint John. These districts are, in turn, subdivided into 20 sub-districts. Although the Virgin Islands are divided into these county equivalents, county level data for the Virgin Islands are not represented in the BLS OES wage data. Additionally, the ACS, which is used to calculate the rent component of the PE GPCI, is not conducted in the Virgin Islands, and we have not been able to obtain malpractice insurance premium data for the Virgin Islands payment locality. Given the absence of county level wage and rent data and the insufficient malpractice premium data by specialty type, we have historically set the three GPCI values for the Virgin Islands payment locality at 1.0.

      For CY 2015, we explored using the available data from the Virgin Islands to more accurately reflect the geographic cost differences for the Virgin Islands payment locality as compared to other PFS localities. Although county level data for the Virgin Islands are not represented in the BLS OES wage data, aggregate territory level BLS OES wage data are available. We believe that using aggregate territory level data is a better reflection of the relative cost differences of operating a medical practice in the Virgin Islands payment locality as compared to other PFS localities than the current approach of assigning a value of 1.0. At our request, our contractor calculated the work GPCI, and the employee wage component and purchased services component of the PE GPCI, for the Virgin Islands payment locality using aggregated 2009 through 2011 BLS OES data.

      As discussed in this section, the ACS is not conducted in the Virgin Islands and we have not been able to obtain malpractice premium data for the Virgin Islands payment locality. Therefore, we assigned a value of 1.0 for the rent index of the PE GPCI and to the MP GPCI.

      Using aggregate territory-level BLS OES wage data resulted in a -

      2.3 percent decrease in the work GPCI, a -4.48 percent decrease in the PE GPCI and a -3.2 percent decrease to the GAF for the Virgin Islands payment locality. However, with the application of the 1.0 work GPCI floor, there is no change to the work GPCI and the overall impact of using actual BLS OES wage data on the Virgin Islands payment locality is only reflected by the change in PE GPCI (-4.48 percent) resulting in a -2.00 percent decrease to the GAF. As mentioned previously in this section, since we have not been able to obtain malpractice premium data for the Virgin Islands payment locality we maintained the MP GPCI at 1.0. As such, we did not propose any changes to the MP GPCI.

      We requested comments on our proposal to use aggregate territory-

      level BLS OES wage data to calculate the work GPCI and the employee wage component and purchased services component of the PE GPCI for the Virgin Islands payment locality beginning for CY 2015, and for future GPCI updates. However, we did not receive any specific comments on this proposal. As discussed above, we believe that using aggregate territory level BLS OES wage data is a better reflection of the relative cost differences of operating a medical practice in the Virgin Islands payment locality as compared to other PFS localities than the current approach of assigning a value of 1.0. Therefore, we will finalize the changes to the GPCI values for the Virgin Islands payment locality as proposed. See Addenda D and E for the CY 2015 GPCIs and summarized GAFs. Additional information on the changes to GPCI values for the Virgin Islands payment locality may be found in our contractor's report, ``Revised Final Report on the CY 2014 Update of the Geographic Practice Cost Index for the Medicare Physician Fee Schedule,'' which is available on the CMS Web site. It is located under the supporting documents section of the CY 2015 PFS final rule with comment period located at http://www.cms.gov/PhysicianFeeSched/.

      Page 67598

      3. Additional Comments

      We received several comments on topics that are not within the scope of proposals in the CY 2015 PFS proposed rule. These comments are briefly discussed below.

      Comment: Many commenters continued to request an increase in the GPCI values for the Puerto Rico payment locality. The commenters stated that the cost of practicing medicine in Puerto Rico continues to rise. The commenters believe that commercial rent and utility costs, and the cost of obtaining medical equipment and supplies are higher in Puerto Rico than many states and territories. Commenters contend that the data used to calculate GPCIs do not accurately reflect the cost of operating a medical practice in Puerto Rico.

      Response: Aside from proposing to use territory-wide wage data for the Virgin Islands payment locality, we finalized the methodology and values for the 7th GPCI update in the CY 2014 PFS final rule with comment period. We did not propose any changes to the GPCIs for the Puerto Rico payment locality, and the commenters on the CY 2015 PFS proposed rule raised the same issues they raised in response to the proposed GPCI update that we finalized in CY 2014. In the CY 2014 PFS final rule with comment period (78 FR 74380 through 74391), we summarized these comments and responded to these issues.

      Comment: A few commenters stated that GPCIs for rural areas are too low which leads to reduced numbers of rural practitioners and reduced access to care. Two commenters stated that the PE GPCI does not account for differences in practice costs for x-rays and imaging studies. The same commenters and another commenter also requested that we replace the current method for calculating the work GPCIs with one that reflects the labor market for physicians and other health professionals as recommended by MedPAC. Another commenter raised questions about state patient compensation fund surcharges for malpractice insurance and the implications of those for the MP GPCI values. Additionally, we received a comment about the physician fee schedule payment localities.

      Response: As noted in this section, we finalized the 7th GPCI update in the CY 2014 PFS final rule with comment period and, other than the proposal relating to the use of territory-wide wage data for the Virgin Islands payment locality, we did not propose any further changes in the CY 2015 PFS proposed rule. We will consider these points raised by commenters when we develop a proposal for the 8th GPCI update.

    3. Medicare Telehealth Services

      1. Billing and Payment for Telehealth Services

      Several conditions must be met in order for Medicare payments to be made for telehealth services under the PFS. Specifically, the service must be on the list of Medicare telehealth services and meet all of the following additional requirements for coverage:

      The service must be furnished via an interactive telecommunications system.

      The practitioner furnishing the service must meet the telehealth requirements, as well as the usual Medicare requirements.

      The service must be furnished to an eligible telehealth individual.

      The individual receiving the services must be in an eligible originating site.

      When all of these conditions are met, Medicare pays an originating site fee to the originating site and provides 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 electronic mail systems 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 regulations at Sec. 410.78(a)(1), store-and-forward means the asynchronous transmission of medical information from an originating site to be reviewed at a later time by the practitioner at the distant site.

      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 means 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 for each Medicare telehealth service. The statute 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

      Page 67599

      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/telehealth/.

      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 eligibility for an originating site would be established and maintained on an annual basis, consistent with other telehealth payment policies (78 FR 74400). Geographic eligibility 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 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 2014 will be considered for the CY 2016 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 2015

      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.

  33. Submitted Requests

    We received several requests in CY 2013 to add various services as Medicare telehealth services effective for CY 2015. The following presents a discussion of these requests, and our proposals for additions to the CY 2015 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 2015:

    CPT codes 90845 (Psychoanalysis); 90846 (family psychotherapy (without the patient present); and 90847 (family psychotherapy (conjoint psychotherapy) (with patient present);

    CPT codes 99354 (prolonged service in the office or other outpatient setting requiring direct patient contact beyond the usual service; first hour (list separately in addition to code for office or other outpatient evaluation and management service); and, 99355 (prolonged service in the office or other outpatient setting requiring direct patient contact beyond the usual service; each additional 30 minutes (list

    Page 67600

    separately in addition to code for prolonged service); and,

    HCPCS codes G0438 (annual wellness visit; includes a personalized prevention plan of service (pps), initial visit; and, G0439 (annual wellness visit, includes a personalized prevention plan of service (pps), subsequent visit).

    We also received requests to add services to the telehealth list that do not meet our criteria for being on the Medicare telehealth list. We did not propose to add the following procedures for the reasons noted:

    CPT codes 92250 (fundus photography with interpretation and report); 93010 (electrocardiogram, routine ECG with at least 12 leads; interpretation and report only), 93307 (echocardiography, transthoracic, real-time with image documentation (2d), includes m-mode recording, when performed, complete, without spectral or color Doppler echocardiography; 93308 (echocardiography, transthoracic, real-time with image documentation (2d), includes m-mode recording, when performed, follow-up or limited study); 93320 (Doppler echocardiography, pulsed wave and/or continuous wave with spectral display (list separately in addition to codes for echocardiographic imaging); complete); 93321 (Doppler echocardiography, pulsed wave and/

    or continuous wave with spectral display (list separately in addition to codes for echocardiographic imaging); follow-up or limited study (list separately in addition to codes for echocardiographic imaging); and 93325 (Doppler echocardiography color flow velocity mapping (list separately in addition to codes for echocardiography). These services include a technical component (TC) and a professional component (PC). By definition, the TC portion of these services needs to be furnished in the same location as the patient and thus cannot be furnished via telehealth. The PC portion of these services could be (and typically would be) furnished without the patient being present in the same location. (Note: For services that have a TC and a PC, there is sometimes an entirely different code that is used when only the PC portion of the service is being furnished, and other times the same CPT code is used with a -26 modifier to indicate that only the PC is being billed.) For example, the interpretation by a physician of an actual electrocardiogram or electroencephalogram tracing that has been transmitted electronically, can be furnished without the patient being present in the same location as the physician. Given the nature of these services, it is not necessary to consider including the PC of these services for addition to the telehealth list. When these PC services are furnished remotely, they do not meet the definition of Medicare telehealth services under section 1834(m) of the Act. Rather, these remote services are considered physicians' services in the same way as services that are furnished in-person without the use of telecommunications technology; they are paid under the same conditions as in-person physicians' services (with no requirements regarding permissible originating sites), and should be reported in the same way as other physicians' services (that is, without the -GT or -GQ modifiers).

    CPT codes 96103 (psychological testing (includes psychodiagnostic assessment of emotionality, intellectual abilities, personality and psychopathology, eg, MMPI), administered by a computer, with qualified health care professional interpretation and report); and, 96120 (neuropsychological testing (eg, Wisconsin Card Sorting Test), administered by a computer, with qualified health care professional interpretation and report). These services involve testing by computer, can be furnished remotely without the patient being present, and are payable in the same way as other physicians' services. These remote services are not Medicare telehealth services as defined under the Act; therefore, we need not consider them for addition to the telehealth list, and the restrictions that apply to telehealth services do not apply to these services.

    CPT codes 90887 (interpretation or explanation of results of psychiatric, other medical examinations and procedures, or other accumulated data to family or other responsible persons, or advising them how to assist patient); 99090 (analysis of clinical data stored in computers (eg, ECGs, blood pressures, hematologic data); 99091 (collection and interpretation of physiologic data (eg, ECG, blood pressure, glucose monitoring) digitally stored and/or transmitted by the patient and/or caregiver to the physician or other qualified health care professional, qualified by education, training, licensure/

    regulation (when applicable) requiring a minimum of 30 minutes of time); 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). These services are not separately payable by Medicare. It would be inappropriate to include services as telehealth services when Medicare does not otherwise make a separate payment for them.

    CPT codes 96101 (psychological testing (includes psychodiagnostic assessment of emotionality, intellectual abilities, personality and psychopathology, eg, MMPI, Rorschach, WAIS), per hour of the psychologist's or physician's time, both face-to-face time administering tests to the patient and time interpreting these test results and preparing the report); 96102 (psychological testing (includes psychodiagnostic assessment of emotionality, intellectual abilities, personality and psychopathology, eg, MMPI and WAIS), with qualified health care professional interpretation and report, administered by technician, per hour of technician time, face-to-face); 96118 (neuropsychological testing (eg, Halstead-Reitan Neuropsychological Battery, Wechsler Memory Scales and Wisconsin Card Sorting Test), per hour of the psychologist's or physician's time, both face-to-face time administering tests to the patient and time interpreting these test results and preparing the report); and, 96119 (neuropsychological testing (eg, Halstead-Reitan Neuropsychological Battery, Wechsler Memory Scales and Wisconsin Card Sorting Test), with qualified health care professional interpretation and report, administered by technician, per hour of technician time, face-to-face). These services are not similar to other services on the telehealth list, as they require close observation of how a patient responds. The requestor did not submit evidence supporting the clinical benefit of furnishing these services on a category 2 basis. As such, we did not propose to add these services to the list of telehealth services.

    CPT codes 57452 (colposcopy of the cervix including upper/

    adjacent vagina; 57454 colposcopy of the cervix including upper/

    adjacent vagina; with biopsy(s) of the cervix and endocervical curettage); and, 57460 (colposcopy of the cervix including upper/

    adjacent vagina; with loop electrode biopsy(s) of the cervix). These services are not similar to other services on the telehealth service list. Therefore, it would not be appropriate to add them on a category 1 basis. The requestor did not submit evidence supporting the clinical benefit of furnishing these services on a category 2 basis. As such, we did not propose to add these services to the list of telehealth services.

    HCPCS code M0064 (brief office visit for the sole purpose of monitoring or changing drug prescriptions used in the treatment of mental psychoneurotic

    Page 67601

    and personality disorders) is being deleted for CY 2015. This code was created specifically to describe a service that is not subject to the statutory outpatient mental health limitation, which limited payment amounts for certain mental health services. Section 102 of the Medicare Improvements for Patients and Providers Act (Pub. L. 110- 275, enacted on July 15, 2008) (MIPPA) required that the limitation on payment for outpatient mental health treatment to 62.5 percent of incurred expenses, in effect since the inception of the Medicare program, be reduced over four years. This limitation on payment for mental health treatment created a higher share of beneficiary coinsurance for these services than for most other Medicare services paid under the PFS. Effective January 1, 2014, 100 percent of expenses incurred for mental health treatment services are considered as incurred for purposes of Medicare, resulting in the same beneficiary cost sharing for these services as for other PFS services. Since the statute was amended to phase out the limitation, and the phase-out was complete effective January 1, 2014, Medicare no longer has a need to distinguish services subject to the mental health limitation from those that are not. Accordingly, the appropriate CPT code can now be used to bill Medicare for the services that would have otherwise been reported using M0064 and M0064 will be eliminated as a telehealth service, effective January 1, 2015.

    Urgent Dermatologic Problems and Wound Care--The American Telemedicine Association (ATA) cited several studies to support adding dermatology services to the telehealth list. However, the request did not include specific codes. Since we did not have specific codes to consider for this request, we cannot evaluate whether the services are appropriate for addition to the Medicare telehealth services list. We note that some of the services that the requester had in mind may be billed under the telehealth office visit codes or the telehealth consultation G-codes.

    In summary, we proposed to add the following codes to the telehealth list on a category 1 basis:

    Psychotherapy services CPT codes 90845, 90846 and 90847.

    Prolonged service office CPT codes 99354 and 99355.

    Annual wellness visit HCPCS codes G0438 and G0439.

    3. Modifying Sec. 410.78 Regarding List of Telehealth Services

    As discussed in section II.E.2. of this final rule with comment period, under the statute, we created an annual process for considering the addition of services to the Medicare telehealth list. Under this process, we propose services to be added to the list in the proposed rule in response to public nominations or our own initiative and seek public comments on our proposals. After consideration of public comments, we finalize additions to the list in the final rule. We have also revised Sec. 410.78(b) each year to include the description of the added services. Because the list of Medicare telehealth services has grown quite lengthy, and given the other mechanisms by which we can make the public aware of the list of Medicare telehealth services for each year, we proposed to revise Sec. 410.78(b) by deleting the description of the individual services for which Medicare payment can be made when furnished via telehealth. Under this proposal, we would continue our current policy to address requests to add to the list of telehealth services through the PFS rulemaking process so that the public would have the opportunity to comment on additions to the list. We also proposed to revise Sec. 410.78(f) to indicate that a list of Medicare telehealth codes and descriptors is available on the CMS Web site.

    The following is a summary of the comments we received regarding the proposed addition of services to the list of Medicare telehealth services.

    Comment: All commenters supported one or more of our proposals to add psychotherapy services (CPT codes 90845, 90846 and 90847); prolonged service office (CPT codes 99354 and 99355); and annual wellness visit (HCPCS codes G0438 and G0439) to the list of Medicare telehealth services for CY 2015.

    Response: We appreciate the commenters' support for the proposed additions to the list of Medicare telehealth services. After consideration of the public comments received, we are finalizing our CY 2015 proposal to add these services to the list of telehealth services for CY 2015 on a category 1 basis.

    Comment: Commenters also agreed with our rationale for rejecting other requested additions to the telehealth list. However, one commenter disagreed with our decision not to propose adding dermatology services, including those furnished using store-and-forward technology, to the list of telehealth services. Another commenter objected to our proposal not to add psychological testing services to the telehealth services list.

    Response: As we noted in the proposed rule, the request to add dermatology services did not include specific codes. Without specific codes to consider, we cannot evaluate whether the services are appropriate for addition to the Medicare telehealth services list. We note that some of the services that the requester had in mind may be billed under the telehealth office visit codes or the telehealth consultation G-codes.

    Concerning payment for services furnished using store-and-forward technology, we note that the statute at section 1861(m) of the Act includes store-and-forward technology as a telecommunication system for telehealth services only in the case of federal telemedicine demonstration programs in Alaska and Hawaii (see Sec. 410.78(d)).

    Concerning psychological testing services, we noted that remote services (CPT codes 96103 and 96120) are not Medicare telehealth services as defined under the Act and thus can be furnished when beneficiary is not in the same place as the practitioner. It would also be counter-productive to add these codes to the telehealth list because, if we did, the telehealth originating site, geographic, and other restrictions would apply to these services.

    CPT codes 90887, 90991, 93358 and 99359 are not separately payable by Medicare. It would be inappropriate to include services as telehealth services when Medicare does not otherwise make a separate payment for them.

    Finally, CPT codes 96101, 96102, 96118 and 96119 are not similar to other services on the telehealth list, as they require close observation of how a patient responds. The requestor did not submit evidence supporting the clinical benefit of furnishing these services on a category 2 basis. As such, we did not propose to add these services to the list of telehealth services.

    We received other public comments on matters related to Medicare telehealth services that were not the subject of proposals in the CY 2015 PFS proposed rule. Because we did not make any proposals regarding these matters, we generally do not summarize or respond to such comments in the final rule. However, we are summarizing and responding to the following comments to acknowledge the interests and concerns of the commenters, and a mechanism to address some of those concerns.

    Many commenters supported the overall expansion of telehealth by:

    Removing geographic restrictions to include both rural and urban areas.

    Revising permissible originating sites to include a patient's home, domiciliary care and first responder vehicles.

    Page 67602

    Adopting a broader definition of telehealth technologies to include services provide via mobile technology, including emails, phone calls, and store-and-forward technologies.

    Adding physical and occupational therapists as practitioners who can remotely furnish telehealth services.

    Adding more services to the telehealth list, including services under category 2.

    Prioritizing coverage of services that include care coordination with the patient's medical home and/or existing treating physicians.

    Considering the use of telehealth technology for the purpose of furnishing direct supervision of services furnished by on-

    site practitioners.

    Using demonstration projects under CMS's Center for Medicare and Medicaid Innovation (CMMI) to collect clinical evidence on the effect of expanding telehealth and to address how telemedicine can be integrated into new payment and delivery models.

    Response: We appreciate the commenters' suggestions. As some commenters noted, we do not have authority to implement many of these revisions under the current statute. The CMS Innovation Center is responsible for developing and testing new payment and service delivery models to lower costs and improve quality for Medicare, Medicaid, and CHIP beneficiaries. As part of that authority, the CMS Innovation Center can consider potential new payment and service delivery models to test changes to Medicare's telehealth payment policies.

    In summary, after consideration of the comments we received, we are finalizing our proposal to add psychotherapy services CPT codes 90845, 90846 and 90847; prolonged service office CPT codes 99354 and 99355; and annual wellness visit HCPCS codes G0438 and G0439 to the list of Medicare telehealth services.

    In addition, we are finalizing our proposal to change our regulation at Sec. 410.78(b) by deleting the description of the individual services for which Medicare payment can be made when furnished via telehealth. We will continue our current policy to address requests to add services to the list of Medicare telehealth services through the PFS rulemaking process so that the public has the opportunity to comment on additions to the list. We are also finalizing our proposal to revise Sec. 410.78(f) to indicate that a list of Medicare telehealth codes and descriptors is available on the CMS Web site.

    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 2016, these requests must be submitted and received by December 31, 2014. 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/.

    5. Telehealth Originating Site Facility Fee Payment Amount Update

    Section 1834(m)(2)(B) of the Act establishes the Medicare telehealth originating site facility fee for telehealth services furnished from October 1, 2001, through December 31 2002, at $20.00. For telehealth services furnished on or after January 1 of each subsequent calendar year, the telehealth originating site facility fee is increased by the percentage increase in the MEI as defined in section 1842(i)(3) of the Act. The MEI increase for 2015 is 0.8 percent. Therefore, for CY 2015, the payment amount for HCPCS code Q3014 (Telehealth originating site facility fee) is 80 percent of the lesser of the actual charge or $24.83. The Medicare telehealth originating site facility fee and MEI increase by the applicable time period is shown in Table 13.

    Table 13--The Medicare Telehealth Originating Site Facility Fee and MEI

    Increase by the Applicable Time Period

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

    MEI

    Facility fee increase Period

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

    $20.00........................ N/A 10/01/2001-12/31/2002

    20.60........................ 3.0 01/01/2003-12/31/2003

    21.20........................ 2.9 01/01/2004-12/31/2004

    21.86........................ 3.1 01/01/2005-12/31/2005

    22.47........................ 2.8 01/01/2006-12/31/2006

    22.94........................ 2.1 01/01/2007-12/31/2007

    23.35........................ 1.8 01/01/2008-12/31/2008

    23.72........................ 1.6 01/01/2009-12/31/2009

    24.00........................ 1.2 01/01/2010-12/31/2010

    24.10........................ 0.4 01/01/2011-12/31/2011

    24.24........................ 0.6 01/01/2012-12/31/2012

    24.43........................ 0.8 01/01/2013-12/31/2013

    24.63........................ 0.8 01/01/2014-12/31/2014

    24.83........................ 0.8 01/01/2015-12/31/2015

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

    1. Valuing New, Revised and Potentially Misvalued Codes

      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 RVUs for CY 1997, CY 2002, CY 2007, and CY 2012. 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, such as codes with high growth rates, codes that are frequently billed together, and high expenditure codes. Section 3134 of the Affordable Care Act codified the misvalued code initiative in section 1848(c)(2)(K) of the Act.

      In the CY 2012 rulemaking process, we proposed and finalized consolidation of the five-year review and the potentially misvalued code activities into an annual review of potentially misvalued codes to avoid redundancies in these efforts and better accomplish our goal of assuring regular assessment of code values. Under the consolidated process, we issue interim final RVUs for all revaluations and new codes in the PFS final rule with comment period, and make payment based upon those values during the calendar year covered by the final rule. (Changes in the PFS methodology that may affect valuations of a variety of codes are issued as proposals in the proposed rule.) We consider and respond to any public comments on the interim final values in the final rule with comment period for the subsequent year. When consolidating these processes, we indicated that it was

      Page 67603

      appropriate to establish interim values for new, revised, and potentially misvalued codes because of the incongruity between the PFS rulemaking cycle and the release of codes by the AMA CPT Editorial Panel and the RUC review process. We stated that if we did not establish interim final values for revalued codes in the final rule with comment period, ``a delay in implementing revised values for codes that have been identified as misvalued would perpetuate payment for the services at a rate that does not appropriately reflect the relative resources involved in furnishing the service and would continue unwarranted distortion in the payment for other services across the PFS.'' We also reiterated that if we did not establish interim final values for new and revised codes, we would either have to delay the use of new and revised codes for one year, or permit each Medicare contractor to establish its own payment rate for these codes. We stated, ``We believe it would be contrary to the public interest to delay adopting values for new and revised codes for the initial year, especially since we have an opportunity to receive significant input from the medical community through the RUC before adopting the values, and the alternatives could produce undesirable levels of uncertainty and inconsistency in payment for a year.''

      1. Current Process for Valuing New, Revised, and Potentially Misvalued Codes

      Under the process finalized in the CY 2012 PFS final rule with comment period, in each year's proposed rule, we propose specific codes and/or groups of codes that we believe may be appropriate to consider under our potentially misvalued code initiative. As part of our process for developing the list of proposed potentially misvalued codes, we consider public nominations for potentially misvalued codes under a process also established in the CY 2012 PFS final rule with comment period. If appropriate, we include such codes in our proposed potentially misvalued code list. In the proposed rule, we solicit comments on the proposed potentially misvalued codes. We then respond to comments and establish a final list of potentially misvalued codes in the final rule for that year. These potentially misvalued codes are reviewed and revalued, if appropriate, in subsequent years. In addition, the RUC regularly identifies potentially misvalued codes using screens that have previously been identified by CMS, such as codes performed together more than 75 percent of the time.

      Generally, the first step in revaluing codes that have been identified as potentially misvalued is for the RUC to review these codes through its standard process, which includes active involvement of national specialty societies for the specialties that ordinarily use the codes. Frequently, the RUC's discussion of potentially misvalued codes will lead the CPT Editorial Panel to make adjustments to the codes involved, such as bundling of codes, creation of new codes or revisions of code descriptors. The AMA has estimated that 75 percent of all annual CPT coding changes result from the potentially misvalued code initiative.

      The RUC provides CMS with recommendations for the work values and direct PE inputs for the codes we have identified as potentially misvalued codes or, in the case of a coding revision, for the new or revised codes that will replace these potentially misvalued codes. (This process is also applied to codes that the RUC identifies using code screens that we have identified, and to new or revised codes that are issued for reasons unrelated to the potentially misvalued code process.) Generally, we receive the RUC recommendations concurrently for all codes in the same family as the potentially misvalued code(s). We believe it is important to evaluate and establish appropriate work and MP RVUs and direct PE inputs for an entire code family at the same time to avoid rank order anomalies and to maintain appropriate relativity among codes. We generally receive the RUC recommendations for the code or replacement code(s) within a year or two following the identification of the code as potentially misvalued.

      We consider the RUC recommendations along with other information that we have, including information submitted by other stakeholders, and establish interim final RVUs for the potentially misvalued codes, new codes, and any other codes for which there are coding changes in the final rule with comment period for a year. There is a 60-day period for the public to comment on those interim final values after we issue the final rule. 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. 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.

      As we discussed in the CY 2012 PFS final rule with comment period, we adopted this consolidated review process to combine all coding revaluations into one annual process allowing for appropriate consideration of relativity in and across code families. In addition, this process assures that we have the benefit of the RUC recommendations for all codes being valued.

      2. Concerns With Current Process

      Some stakeholders who have experienced reductions in payments as the result of interim final valuations have objected to the process by which we revise or establish values for new, revised, and potentially misvalued codes. Some have stated that they did not receive notice of the possible reductions before they occurred. Generally, stakeholders are aware that we are considering changes in the payment rates for particular services either because CPT has made changes to codes or because we have identified the codes as potentially misvalued. As the RUC considers the appropriate value for a service, representatives of the specialties that use the codes are involved in the process. The RUC usually surveys physicians or other practitioners who furnish the services described by the codes regarding the time it takes to furnish the services, and representatives of the specialty(ies) also participate in the RUC meetings where recommendations for work RVUs and direct PE inputs are considered. Through this process, representatives of the affected specialties are generally aware of the RUC recommendations.

      Some stakeholders have stated that even when they are aware that the RUC has made recommendations, they have no opportunity to respond to the RUC recommendations before we consider them in adopting interim final values because the RUC actions and recommendations are not public. Some stakeholders have also said that the individuals who participate in the RUC review process are not able to share the recommendations because they have signed a confidentiality agreement. We note, however, that at least one specialty society has raised funds via its Web site to fight a ``pending cut'' based upon its knowledge of RUC recommendations for specific codes prior to CMS action on the recommendation. Additionally, some stakeholders have pointed out that some types of suppliers that are paid

      Page 67604

      under the PFS are not permitted to participate in the RUC process at all.

      We recognize that some stakeholders, including those practitioners represented by societies that are not participants in the RUC process, may not be aware of the specifics of the RUC recommendations before we consider them in establishing interim final values for new, revised, and potentially misvalued codes. We note that, as described above, before we review a service as a potentially misvalued code, we go through notice and comment rulemaking to identify it as a potentially misvalued code. Thus, the public has notice and an opportunity to comment on whether we should review the values for a code before we finalize the code as potentially misvalued and begin the valuation process. As a result, all stakeholders should be aware that a particular code is being considered as potentially misvalued and that we may establish revised interim final values in a subsequent final rule with comment period. As noted above, there may be some codes for which we receive RUC recommendations based upon their identification by the RUC through code screens that we establish. These codes are not specifically identified by CMS through notice and comment rulemaking as potentially misvalued codes. We recognize that if stakeholders are not monitoring RUC activities or evaluating Medicare claims data, they may be unaware that these codes are being reviewed and could be revalued on an interim final basis in a final rule with comment period for a year.

      In recent years, we have increased our scrutiny of the RUC recommendations and have increasingly found cause to modify the values recommended by the RUC in establishing interim final values under the PFS. Sometimes we also find it appropriate, on an interim final basis, to refine how the CPT codes are to be used for Medicare services or to create G-codes for reporting certain services to Medicare. Some stakeholders have objected to such interim final decisions because they do not learn of the CMS action until the final rule with comment period is issued. Stakeholders said that they do not have an opportunity to meaningfully comment and for CMS to address their comments before the coding or valuation decision takes effect.

      We received comments on the CY 2014 PFS final rule with comment period suggesting that the existing process for review and adoption of interim final values for new, revised, and misvalued codes violates section 1871(a)(2) of the Act, which prescribes the rulemaking requirements for the agency in establishing payment rates. In response to those commenters, we note that the process we use to establish interim final rates is in full accordance with the statute and we do not find this a persuasive reason to consider modifying the process that we use to establish PFS rates.

      Our recent revaluation of the four epidural injection codes provides an example of the concerns that have been expressed with the existing process. In the CY 2014 PFS final rule with comment period, we established interim final values for four epidural injection codes, which resulted in payment reductions for the services when furnished in the office setting of between 35 percent and 56 percent. (In the facility setting, the reductions ranged from 17 percent to 33 percent.) One of these codes had been identified as a potentially misvalued code 2 years earlier. The affected specialties had been involved in the RUC process and were generally aware that the family of codes would be revalued on an interim basis in an upcoming rule. They were also aware that the RUC had made significant changes to the direct PE inputs, including removal of the radiographic-fluoroscopy room, which explains, in large part, the reduction to values in the office setting. The societies representing the affected specialty were also aware of significant reductions in the RUC-recommended ``time'' to furnish the procedures based on the most recent survey of practitioners who furnish the services, which resulted in reductions in both the work and PE portion of the values. Although the specialties were aware of the changes that the RUC was recommending to direct PE inputs, they were not specifically aware of how those changes would affect the values and payment rate. In addition, we decreased the work RVUs for these procedures because we found the RUC-recommended work RVUs did not adequately reflect the RUC-recommended decreases in time. This decision is consistent with our general practice when the best available information shows that the time involved in furnishing the service has decreased, and in the absence of information suggesting an increase in work intensity. Since the interim final values for these codes were issued in the CY 2014 PFS final rule with comment period, we have received numerous comments that will be useful to us as we consider finalizing values for these codes. If we had followed a process that involved proposing values for these codes in a proposed rule, we would have been able to consider the additional information contained in these comments prior to making payments for the services based upon revised values. (See section II.B.3.b.(2) of this final rule with comment period for a discussion of proposed valuation of these epidural injection codes for CY 2015.)

      3. Alternatives to the Current Process

      In the proposed rule, we noted that given our heightened review of the RUC recommendations and the increased concerns expressed by some stakeholders, we believed that an assessment of our process for valuing these codes was warranted. To that end, we considered potential alternatives to address the timing and rulemaking issues associated with establishing values for new, revised and potentially misvalued codes (as well as for codes within the same families as these codes). Specifically, we explored three alternatives to our current approach:

      Propose work and MP RVUs and direct PE inputs for all new, revised and potentially misvalued codes in a proposed rule.

      Propose changes in work and MP RVUs and direct PE inputs in the proposed rule for new, revised, and potentially misvalued codes for which we receive RUC recommendations in time; continue to establish interim final values in the final rule for other new, revised, and potentially misvalued codes.

      Increase our efforts to make available more information about the specific issues being considered in the course of developing values for new, revised and potentially misvalued codes to increase transparency, but without making changes to the existing process for establishing values.

      In the proposed rule we discussed each of these alternatives as follows.

      (a) Propose work and MP RVUs and direct PE inputs for new, revised, and potentially misvalued codes in the proposed rule:

      Under this approach, we stated that we would evaluate the RUC recommendations for all new, revised, and potentially misvalued codes, and include proposed work and MP RVUs and direct PE inputs for the codes in the first available PFS proposed rule. We would receive and consider public comments on those proposals and establish final values in the final rule. The primary obstacle to this approach relates to the current timing of the CPT coding changes and RUC activities. Under the current calendar, all CPT coding changes and most RUC recommendations are not available to us in time to include proposed values for

      Page 67605

      all codes in the proposed rule for that year.

      Therefore, we stated that if we were to adopt this proposal, which would require us to propose changes in inputs before we revalue codes based upon those values, we would need a mechanism to pay for services for which the existing codes would no longer be available, or for which there would be changes for a given year.

      As we noted in the CY 2012 PFS final rule with comment period, the RUC recommendations are an essential element that we consider when valuing codes. Likewise, we recognize the significant contribution that the CPT Editorial Panel makes to the success of the potentially misvalued code initiative through its consideration and adoption of coding changes. Although we have increased our scrutiny of the RUC recommendations in recent years and accepted fewer of the recommendations without making our own refinements, the CPT codes and the RUC recommendations continue to play a major role in our valuations. For many codes, the surveys conducted by specialty societies as part of the RUC process are the best data that we have regarding the time and intensity of work. The RUC determines the criteria and the methodology for those surveys. It also reviews the survey results. This process allows for development of survey data that are more reliable and comparable across specialties and services than would be possible without having the RUC at the center of the survey vetting process. In addition, the debate and discussion of the services at the RUC meetings in which CMS staff participate provides a good understanding of what the service entails and how it compares to other services in the family, and to services furnished by other specialties. The debate among the specialties is also an important part of this process. Although we increasingly consider data and information from many other sources, and we intend to expand the scope of those data and sources, the RUC recommendations remain a vital part of our valuation process.

      Thus, if we were to adopt this approach, we would need to address how to make payment for the services for which new or revised codes take effect for the following year but for which we did not receive RUC recommendations in time to include proposed work values and PE inputs in the proposed rule. Because the annual coding changes are effective on January 1st of each year, we would need a mechanism for practitioners to report services and be paid appropriately during the interval between the date the code takes effect and the time that we receive RUC recommendations and complete rulemaking to establish values for the new and revised codes. One option would be to establish G-codes with identical descriptors to the predecessors of the new and revised codes and, to the fullest extent possible, carry over the existing values for those codes. This would effectively preserve the status quo for one year.

      The primary advantage of this approach would be that the RVUs for all services under the PFS would be established using a full notice and comment procedure, including consideration of the RUC recommendations, before they take effect. In addition to having the benefit of the RUC recommendations, this would provide the public the opportunity to comment on a specific proposal prior to it being implemented. This would be a far more transparent process, and would assure that we have the full benefit of stakeholder comments before establishing values.

      One drawback to such a process is that the use of G-codes for a significant number of codes may create an administrative burden for CMS and for practitioners. Presumably, practitioners would need to use the G-codes to report certain services for purposes of Medicare, but would use the new or revised CPT codes to report the same services to private insurers. The number of G-codes needed each year would depend on the number of CPT code changes for which we do not receive the RUC recommendations in time to formulate a proposal to be included in the proposed rule for the year. To the extent that we receive the RUC recommendations for all new and revised codes in time to develop proposed values for inclusion in the proposed rule, there would be no need to use G-codes for this purpose.

      Another drawback is that we would need to delay for at least one year the revision of values for any misvalued codes for which we do not receive RUC recommendations in time to include a proposal in the proposed rule. For a select set of codes, we would be continuing to use the RVUs for the codes for an additional year even though we know they do not reflect the most accurate resources. Since the PFS is a budget neutral system, misvalued services affect payments for all services across the fee schedule. On the other hand, if we were to take this approach, we would have the full benefit of public comments received on the proposed values for potentially misvalued services before implementing any revisions.

      (b) Propose changes in work and MP RVUs and PE inputs in the proposed rule for new, revised, and potentially misvalued codes for which we receive RUC recommendations in time; continue to establish interim final values in the final rule for other new, revised, and potentially misvalued codes:

      This alternative approach would allow for notice and comment rulemaking before we adopt values for some new, revised and potentially misvalued codes (those for which we receive RUC recommendations in time to include a proposal in the proposed rule), while others would be valued on an interim final basis (those for which we do not receive the RUC recommendations in time). Under this approach, we would establish values in a year for all new, revised, and potentially misvalued codes, and there would be no need to provide for a mechanism to continue payment for outdated codes pending receipt of the RUC recommendations and completion of a rulemaking cycle. For codes for which we do not receive the RUC recommendations in time to include a proposal in the proposed rule for a year, there would be no change from the existing valuation process.

      This would be a balanced approach that recognizes the benefits of a full opportunity for notice and comment rulemaking before establishing rates when timing allows, and the importance of establishing appropriate values for the current version of CPT codes and for potentially misvalued codes when the timing of the RUC recommendations does not allow for a full notice and comment procedure.

      However, this alternative would go only part of the way toward addressing concerns expressed by some stakeholders. For those codes for which the RUC recommendations are not received in time for us to include a proposal in the proposed rule, Medicare payment for one year would still be based on inputs established without the benefit of full public notice and comment. Another concern with this approach is that it could lead to the valuation of codes within the same family at different times depending on when we receive RUC recommendations for each code within a family. As discussed previously, we believe it is important to value an entire code family together to make adjustments to account appropriately for relativity within the family and between the family and other families. If we receive RUC recommendations in time to propose

      Page 67606

      values for some, but not for all, codes within a family, we would respond to comments in the final rule to establish final values for some of the codes while adopting interim final values for other codes within the same family. The differences in the treatment of codes within the same family could limit our ability to value codes within the same family with appropriate relativity. Moreover, under this alternative, the main determinant of how a code would be handled would be the timing of our receipt of the RUC recommendation for the code. Although this approach would offer stakeholders the opportunity to comment on specific proposals in the proposed rule, the adoption of changes for a separate group of codes in the final rule could significantly change the proposed values simply due to the budget neutrality adjustments due to additional codes being valued in the final rule.

      (c) Increase our efforts to make available more information about the specific issues being considered in the course of developing values for new, revised and potentially misvalued codes in order to increase transparency, but without a change to the existing process for establishing values:

      The main concern with continuing our current approach is that stakeholders have expressed the desire to have adequate and timely information to permit the provision of relevant feedback to CMS for our consideration prior to establishing a payment rate for new, revised, and potentially misvalued codes. We could address some aspects of this issue by increasing the transparency of the current process. Specifically, we could make more information available on the CMS Web site before interim final values are established for codes. Examples of such information include an up-to-date list of all codes that have been identified as potentially misvalued, a list of all codes for which RUC recommendations have been received, and the RUC recommendations for all codes for which we have received them.

      Although the posting of this information would significantly increase transparency for all stakeholders, it still would not allow for full notice and comment rulemaking procedures before values are established for payment purposes. Nor would it provide the public with advance information about whether or how we will make refinements to the RUC recommendations or coding decisions in the final rule with comment period. Thus, stakeholders would not have an opportunity to provide input on our potential modifications before interim final values are adopted.

      4. Proposal To Modify the Process for Establishing Values for New, Revised, and Potentially Misvalued Codes

      After considering the current process, including its strengths and weaknesses, and the alternatives to the current process described previously, we proposed to modify our process to make all changes in the work and MP RVUs and the direct PE inputs for new, revised and potentially misvalued services under the PFS by proposing the changes in the proposed rule, beginning with the PFS proposed rule for CY 2016. We proposed to include proposed values for all new, revised and potentially misvalued codes for which we have complete RUC recommendations by January 15th of the preceding year. We also proposed to delay revaluing the code for one year (or until we receive RUC recommendations for the code before January 15th of a year) and include proposed values in the following year's rule if the RUC recommendation was not received in time for inclusion in the proposed rule. Thus, we would include proposed values prior to using the new code (in the case of new or revised codes) or revising the value (in the case of potentially misvalued codes). Due to the complexities involved in code changes and rate setting, there could be some circumstances where, even when we receive the RUC recommendations by January 15th of a year, we are not able to propose values in that year's proposed rule. For example, we might not have recommendations for the whole family or we might need additional information to appropriately value these codes. In situations where it would not be appropriate or possible to propose values for certain new, revised, or potentially misvalued codes, we would treat them in the same way as those for which we did not receive recommendations before January 15th.

      For new, revised, and potentially misvalued codes for which we do not receive RUC recommendations before January 15th of a year, we proposed to adopt coding policies and payment rates that conform, to the extent possible, to the policies and rates in place for the previous year. We would adopt these conforming policies on an interim basis pending our consideration of the RUC recommendations and the completion of notice and comment rulemaking to establish values for the codes. For codes for which there is no change in the CPT code, it is a simple matter to continue the current valuation. For services for which there are CPT coding changes, it is more complicated to maintain the current payment rates until the codes can be valued through the notice and comment rulemaking process. Since the changes in CPT codes are effective on January 1st of a year, and we would not have established values for the new or revised codes (or other codes within the code family), it would not be practical for Medicare to use those CPT codes. For codes that were revised or deleted as part of the annual CPT coding changes, when the changes could affect the value of a code and we have not had an opportunity to consider the relevant RUC recommendations prior to the proposed rule, we propose to create G-codes to describe the predecessor codes to these codes. If CPT codes are revised in a manner that would not affect the resource inputs used to value the service (for example, a grammatical changes to CPT code descriptors), we could use these revised codes and continue to pay at the rate developed through the use of the same resource inputs. For example, if a single CPT code was separated into two codes and we did not receive RUC recommendations for the two codes before January 15th of the year, we would assign each of those new codes an ``I'' status indicator (which denotes that the codes are ``not valid for Medicare purposes''), and those codes could not be used for Medicare payment during the year. Instead, we would create a G-code with the same description as the single predecessor CPT code and continue to use the same inputs as the predecessor CPT code for that G-code during the year.

      For new codes that describe wholly new services, as opposed to new or revised codes that are created as part of a coding revision of a family or that describe services are already on the PFS, we would make every effort to work with the RUC to ensure that we receive recommendations in time to include proposed values in the proposed rule. However, if we do not receive timely recommendations from the RUC for such a code and we determine that it is in the public interest for Medicare to use a new code during the code's initial year, we would establish values for the code's initial year. As we do under our current policy, if we receive the RUC recommendations in time to consider them for the final rule, we propose to establish values for the initial year on an interim final basis subject to comment in the final rule. In the event we do not receive RUC recommendations in time to consider them for the final rule, or in other situations where it would not be appropriate to establish interim final

      Page 67607

      values (for example, because of a lack of necessary information about the work or the price of the PE inputs involved), we would contractor price the code for the initial year.

      We specifically sought comments on the following topics:

      Is this proposal preferable to the present process? Is another one of the alternatives better?

      If we were to implement this proposal, is it better to move forward with the changes, or is more time needed to make the transition such that implementation should be delayed beyond CY 2016? What factors should we consider in selecting an implementation date?

      Are there alternatives other than the use of G-codes that would allow us to address the annual CPT changes through notice and comment rather than interim final rulemaking?

      Comment: The vast majority of commenters support a process, such as the one we proposed, that would result in having an opportunity for public comment on specific CMS proposals to change rates prior to payments being made based upon those rates. Commenters supporting a more transparent process include most medical organizations. MedPAC supported including proposals for rate changes in the proposed rule, but disagreed with preserving existing rates when RUC recommendations were not received in time to value in the proposed rule stating that this perpetuates paying at rates that we know are misvalued. As an alternative, MedPAC suggested that for codes for which we received RUC recommendations after the deadline for the proposed rule, we establish interim final values using the existing process. MedPAC also encouraged us to work with the CPT Editorial Panel and the RUC to better disseminate information about coding and payment recommendations that might be used for interim values as far in advance as possible. Several commenters who do not currently participate in the development of RUC recommendations suggested that we require the RUC to make its operations more transparent. Most of the commenters that supported the proposal also suggested making at least some modifications to the proposal. Some commenters indicated there was no need for a change from the current process. Another commenter stated ``CMS's proposal is overly complex, potentially burdensome, and goes well beyond the principal request of the medical specialty societies and Congress--that is, for CMS to publish reimbursement changes for misvalued codes in the proposed rule, as opposed to waiting until the final rule.''

      Response: We appreciate the many comments in support of our proposal to be more transparent in our ratesetting process by including proposed changes in inputs for new, revised, and potentially misvalued codes in the PFS proposed rules each year. We received only minimal comments on the other alternatives we presented, and only one comment suggesting that the current process was ideal and should be maintained. Thus, we are finalizing the proposal, with the modifications discussed below, to change our process for establishing values for new, revised, and potentially misvalued codes each year by proposing values for them in the proposed rule. We note that the CPT Editorial Panel and the RUC have made significant efforts in recent years to make their processes more transparent, such as making minutes of meetings publicly available. We encourage them to continue these efforts and also to consider ways that all physicians, practitioners and other suppliers paid under the PFS are aware of issues that are being considered by the RUC, and have an opportunity to provide input. With regard to comments suggesting that we propose values for some codes in the proposed rule and establish values for others as interim final in the final rule with comment period, as we discussed in making the proposal, we believe this type of system has several flaws. Most significantly, since the PFS is a budget neutral system, proposals are more meaningful when they can be considered in relation to all codes being revalued in a year in order to allow public comment on the entire fee schedule at one time. Additionally, we believe it is difficult to justify the presence or absence of an opportunity for public comment in advance of our adopting and using new values and inputs for services when the outcome essentially depends upon when we receive RUC recommendations.

      Comment: Commenters expressed mixed opinions on when the new process should begin. The AMA, the RUC, and most medical specialties opposed the proposed CY 2016 implementation and asked that it be delayed until CY 2017. Commenters supporting a delay suggested that much work had already been done for the CY 2016 coding cycle in anticipation that these codes could be used for CY 2016, and stated it seems unfair to now delay valuing these codes because the process is being changed. These commenters also suggested that by delaying until CY 2017, the CPT Editorial Panel and the RUC would have time to adjust their agendas and workload so as to provide more recommendations in time for the proposed rule. By contrast, several commenters, including those with major code revisions for CY 2015, such as codes for radiation therapy and upper gastrointestinal procedures, suggested that we should implement the new process immediately, and thus, delay implementation of the new code sets and values so that they could be issued as proposals in the CY 2016 proposed rule. Although each of the commenters took some unique positions in supporting a delay, they emphasized the importance of the opportunity to comment on our specific proposals for valuation as a major consideration for the delay. A few other commenters also suggested that the benefit of the opportunity for public comment prior to changing values warrants immediate implementation. Some commenters supported a CY 2016 implementation date as we proposed. A small group of commenters suggested an interim approach under which, for CY 2016, we would publish ``some, but not all, values'' in the proposed rule and use the interim final approach for others.

      Response: After reviewing the comments, we understand that the implementation of a new process such as this one will affect stakeholders in differing ways. As we consider the most appropriate time frame for implementation, we believe that flexibility in implementation offers the optimal solution. Accordingly, we are delaying the adoption of two new codes sets (radiation therapy and lower gastrointestinal endoscopies) until CY 2016 as requested by affected stakeholders so that those most affected by these significant changes have the opportunity to comment on our proposals for valuing these codes sets before they are implemented. (See section II.G.3 of this final rule.)

      Similarly, as requested by the AMA and most other medical specialty societies, we are delaying the complete implementation of this process so that those who have requested new codes and modifications in existing codes with the expectation that they would be valued under the PFS for CY 2016 will not be negatively affected by timing of this change. We note that the AMA has been working to develop timeframes that would allow a much higher percentage of codes to be addressed in the proposed rule, and has shared with us some plans to achieve this goal. We appreciate AMA's efforts and are confident that with the finalization of this process, the CPT Editorial Panel and the RUC will be able to adjust their timelines and processes so that most, if

      Page 67608

      not all, of the annual coding changes and valuation recommendations can be addressed in the proposed rule prior to the effective date of the coding changes. This delay in implementation will provide additional time for these bodies to adjust their agendas and the timing of their recommendations to CMS to more appropriately align with the new process. As suggested by some commenters, we will use CY 2016 as a transition year. In the PFS proposed rule for CY 2016, we will propose values for the new, revised and potentially misvalued codes for which we receive the RUC recommendations in time for inclusion in the CY 2016 proposed rule. We will also include proposals for the two code sets delayed from CY 2015 in the CY 2016 proposed rule, as discussed above. For those new, revised, and potentially misvalued codes for which we do not receive RUC recommendations in time for inclusion in the proposed rule, we anticipate establishing interim final values for them for CY 2016, consistent with the current process. Beginning with valuations for CY 2017, the new process will be applicable to all codes. In other words, 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 in order to facilitate continued payment for certain services for which we do not receive RUC 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 RUC recommendations in time to propose values. Consistent with this policy, we are finalizing our proposed regulatory change to Sec. 414.24 with the addition of the phrase ``For valuations for calendar year 2017 and beyond,'' to paragraph (b) to reflect the implementation for all CY 2017 valuations.''

      Comment: Commenters also addressed the January 15th deadline for valuations to be considered for the proposed rule. The AMA recommended a deadline of 30 days after the RUC's January meeting to allow time to submit complete recommendations for the proposed rule. Many others supported this, with some commenters suggesting a variety of dates between January 31st and April. Commenters suggested using an April deadline so that we could include the recommendations from the April RUC meeting in the proposed rule.

      Response: In proposing a deadline for inclusion in the proposed rule, we attempted to strike a balance that allows CMS adequate time for CMS to do a thorough job in vetting recommendations and formulating proposals, and allows the RUC as much time as possible to complete its activities. Review of RUC recommendations and application of the PFS methodology to particular codes requires significant time to complete. With new statutory requirements being implemented in CY 2017, such as those requiring multi-year transitions of certain changes in values and modification to PFS payments if specified targets are not met, we believe we will need more time to complete the process of formulating proposals. We believe that we need to establish a consistent deadline for receipt of RUC recommendations in order to allow all stakeholders and CMS to plan appropriately. To balance competing priorities, we are finalizing a deadline of February 10th. Our ability to complete our work in this more limited time will depend in large part on the volume of recommendations handled at the last RUC meeting and when we receive those recommendations. We are seeking the RUC's assistance in minimizing the recommendations that we receive after the beginning of the year.

      Comment: The majority of commenters opposed the use of G-codes, primarily citing the administrative burden of having to use a separate set of codes for Medicare claims. One commenter called the G-code proposal ``unworkable.'' In addition, MedPAC objected to the principal of attempting to maintain rates that are known to be misvalued. Those supporting the use of G-codes generally recognized the administrative burden, but believed the importance of the opportunity for public comment on proposed values before they take effect outweighed the administrative inconvenience. Commenters urged us to minimize the use of G-codes.

      Response: We recognize the commenters' concerns with the use of G-

      codes. We agree that it is preferable to use CPT codes whenever possible. Under our finalized process, the use of G-codes for the purpose of holding over current coding and payment policies should not be necessary, generally, as long as we receive RUC recommendations for all new, revised and potentially misvalued codes before February 10th of the prior year. However, we need to preserve our ability to establish a proxy for current coding and values in situations where we receive the RUC recommendations too late or, for some other reason, encounter serious difficulty developing proposed values for revised code sets. In the proposed rule, we sought input as to ways to achieve this without using G-codes. The only suggestion offered by commenters was to value such codes on an interim final basis. As we discuss above, we believe the program and its stakeholders are better served by delaying revaluations for one year while we used the notice and comment process to obtain public comments in advance. The comments on this proposal were overall overwhelming supportive of this point of view. Accordingly, we are not foreclosing the possibility of using G-codes for this purpose when warranted by the circumstances. However, we are cognizant of the difficulties created by the use of G-codes and will seek to minimize their use. We also note that the RUC and stakeholders can assist us in minimizing the use of G-codes by taking steps to insure that we receive RUC recommendations as early as possible.

      5. Refinement Panel

      As discussed in the 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 comprised 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 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.

      As we considered making changes to the process for valuing codes, 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 interim final values. It provides an opportunity for stakeholders to provide

      Page 67609

      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. We noted that if our proposal to modify the valuation process for new, revised, and potentially misvalued codes is adopted, there would no longer be interim final values except for very few codes that describe totally new services. Thus, we proposed eliminating the refinement panel process.

      We also noted that by using the proposed process for new, revised, and potentially misvalued codes, we believed the consideration of additional clinical information and any other issues associated with the CMS proposed values could be addressed through the notice and comment process. Similarly, prior to CY 2012 when we consolidated the five-year valuation, changes made as part of the five-year review process were addressed in the proposed rule and those codes were generally not subject to the refinement process. The notice and comment process would provide stakeholders with complete information on the basis and rationale for our proposed inputs and any relating coding policies. We also noted that an increasing number of requests for refinement do not include new clinical information that would justify a change in the work RVUs and that was not available at the time of the RUC meeting, in accordance with the current criteria for refinement. Thus, we did not believe the elimination of the refinement panel process would negatively affect the code valuation process. We believe the proposed process, which includes a full notice and comment procedure before values are used for purposes of payment, offers stakeholders a better mechanism for providing any additional data for our consideration and discussing any concerns with our proposed values than the current refinement process

      Comment: We received many comments on our proposal to eliminate the refinement panel, but most addressed problems with the existing refinement process and suggested improvements and alternatives rather than reasons not to eliminate the refinement panel. Concerns with the refinement panel process included that CMS imposed too high a standard for referring codes to refinement and that CMS decreasingly changed values based upon the refinement panel results. Some noted that organizations with limited resources are disadvantaged compared to those with significant resources to overturn any CMS interim final values without a refinement process. In addition, some commenters stated that elimination of the refinement panel runs contrary to the transparency that CMS is trying to achieve. Many discussed their previous understanding that the refinement panel was essentially an appeals process for interim final values.

      Commenters supported ``a fair, objective, and consistently applied appeals process that would be open to any commenting organization.'' Commenters expressed concern that the elimination of the refinement panel without a replacement mechanism ``indicates that CMS will no longer seek the independent advice of contractor medical officers and practicing physicians and will solely rely on Agency staff to determine if the comment is persuasive in modifying a proposed value. The lack of any perceived organized appeal process will likely lead to a fragmented lobbying effort, rather than an objective review process.''

      MedPAC suggested that we use a panel with membership limited to those without a financial stake in the process, such as contractor medical directors, experts in medical economics and technology diffusion, private payer representatives, and a mix of physicians and other health professionals not directly affected by the RVUs in question. It also suggested user fees to provide the resources needed or such a refinement panel.

      Response: We acknowledge the commenters' concerns and believe that some of the dissatisfaction with the current refinement panel mechanism stems from the expectation that it constitutes an appeals process. We do not agree. We believe the purpose of the refinement panel is to give us additional information to consider in exercising our responsibility to establish appropriate RVUs for Medicare services. Like many of the commenters, we believe the refinement panel is not achieving its purpose. Rather than providing us with additional information to assist us in establishing work RVUs, most often the refinement panel discussion reiterates the issues raised and information discussed at the RUC. Since we had access to this information at the time interim final values were established, it seems unlikely that a repeat discussion of the same issues would lead us to change valuations based upon information that already had been carefully considered. We remain concerned about the amount of resources devoted to refinement panel activities as compared to the benefit received. However, in light of the significant concerns raised by commenters, we are not finalizing our proposal to eliminate the refinement panel. We will use the refinement panel for consideration of interim final rates for CY 2015 under the existing rules. We will also explore ways to address the many concerns that we and stakeholders have about the refinement panel process and whether the change in process eliminates the need for a refinement panel.

      We are also finalizing our proposed change to the regulation at Sec. 414.24 with the addition of the phrase ``For valuations for calendar year 2017 and beyond,'' to paragraph (b) to reflect implementation of the revised process for all valuations beginning with those for CY 2017.

    2. Establishing RVUs for CY 2015

      1. Methodology

      We conducted a review of each code identified in this section and reviewed the current work RVU, if one exists, the RUC-recommended work RVUs, intensity, and time to furnish the preservice, intraservice, and postservice activities, as well as other components of the service that contribute to the value. Our review generally includes, but is not limited to, a review of information provided by the RUC, Health Care Professionals Advisory Committee (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. 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 components could be the CPT

      Page 67610

      codes that make up the bundled code. 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 appropriately value services 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 physician 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. The RVUs and other payment information for all CY 2015 payable codes are available in Addendum B. The RVUs and other payment information for all codes subject to public comment are available in Addendum C. Both addenda are available on the CMS Web site under downloads for the CY 2015 PFS final rule with comment period at http://www.cms.gov/physicianfeesched/downloads/. The time values for all CY 2015 codes are listed in a file called ``CY 2015 PFS Physician Time,'' available on the CMS Web site under downloads for the CY 2015 PFS final rule with comment period at http://www.cms.gov/physicianfeesched/downloads/.

      2. Addressing CY 2014 Interim Final RVUs

      In this section, we are responding to the public comments received on specific interim final values established in the CY 2014 PFS final rule with comment period and discussing the final values that we are establishing for CY 2015. The final CY 2015 work, PE, and MP RVUs are in Addendum B of a file called ``CY 2015 PFS Addenda,'' available on the CMS Web site under downloads for the CY 2015 PFS final rule with comment period at http://www.cms.gov/physicianfeesched/PFS-Federal-Regulation-Notices.html/. The direct PE inputs are listed in a file called ``CY 2015 PFS Direct PE Inputs,'' available on the CMS Web site under downloads for the CY 2015 PFS final rule with comment period at http://www.cms.gov/physicianfeesched/PFS-Federal-Regulation-Notices.html/.

  34. Finalizing CY 2014 Interim Final Work RVUs for CY 2015

    (i) Refinement Panel

    (1) Refinement Panel Process

    As discussed in the 1993 PFS final rule with comment period (57 FR 55938), we adopted a refinement panel process soon after implementing the fee schedule to assist us in reviewing the public comments on CPT codes with interim final work RVUs and in developing final work values for the subsequent year. We decided the panel would be comprised 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 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. Depending on the number and range of codes that are subject to refinement in a given year, we establish refinement panels with representatives from four groups: Clinicians representing the specialty identified with the procedures in question; physicians with practices in related specialties; primary care physicians; and contractor medical directors (CMDs). Typical panels have included 8 to 10 physicians across the four groups.

    Following the addition of section 1848(c)(2)(K) to the Act, which requires the Secretary periodically to 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 believed that the refinement panel process might provide an opportunity to review and discuss the proposed and interim final work RVUs with a clinically diverse group of experts, who could provide informed recommendations following the discussion. Therefore, we indicated that we would continue the refinement process, but with administrative modification and clarification. We also noted that we would continue using the established panel composition that includes representatives from the four groups--clinicians representing the specialty identified with the procedures in question, physicians with practices in related specialties, primary care physicians, and CMDs.

    At that time, we made a change in how we calculated refinement panel results. The basis of the refinement panel process is that, following discussion of the information but without an attempt to reach a consensus, each member of the panel submits an independent rating to CMS. Historically, the refinement panel's recommendation to change a work value or to retain the interim final value had

    Page 67611

    hinged solely on the outcome of a statistical test on the ratings (an F-test of panel ratings among the groups of participants). Over time, we found the statistical test used to evaluate the RVU ratings of individual panel members became less reliable as the physicians in each group tended to select a previously discussed value, rather than developing a unique value, thereby reducing the observed variability needed to conduct a robust statistical test. In addition, reliance on values developed using the F-test also occasionally resulted in rank order anomalies among services (that is, a more complex procedure is assigned lower RVUs than a less complex procedure). As a result, we eliminated the use of the statistical F-test and replaced it with the median work value of the individual panel members' ratings. We stated that this approach would simplify the refinement process administratively, while providing a result that reflects the summary opinion of the panel members based on a commonly used measure of central tendency that is not significantly affected by outlier values. We also clarified that we have the final authority to set the work RVUs, including making adjustments to the work RVUs resulting from the refinement process, and that we will make such adjustments if warranted by policy concerns (75 FR 73307).

    We remind readers that the refinement panels are not intended to review the work RVUs for every code for which we did not accept the RUC-recommended work RVUs. Rather, refinement panels are designed for situations where there is new clinical information available that might provide a reason for a change in work values and where a multispecialty panel of physicians might provide input that would assist us in establishing work RVUs. To facilitate the selection of services for the refinement panels, commenters seeking consideration by a refinement panel should specifically state in their public comments that they are requesting refinement panel review. Furthermore, we have asked commenters requesting refinement panel review to submit any new clinical information concerning the work required to furnish a service so that we can consider whether the new information warrants referral to the refinement panel (57 FR 55917).

    We note that most of the information presented during the last several refinement panel discussions has been duplicative of the information provided to the RUC during its development of recommendations and considered by CMS in establishing values. As detailed above, we consider information and recommendations from the RUC when assigning proposed and interim final RVUs to services. Thus, if the only information that a commenter has to present is information already considered by the RUC, referral to a refinement panel is not appropriate. We request that commenters seeking refinement panel review of work RVUs submit supporting information that has not already been considered by the RUC in developing recommendations or by CMS in assigning proposed and interim final work RVUs. We can make best use of our resources, as well as those of the specialties and physician volunteers involved, by avoiding duplicative consideration of information by the RUC, CMS, and a refinement panel. To achieve this goal, CMS will continue to critically evaluate the need to refer codes to refinement panels in future years, specifically considering any new information provided by commenters.

    (2) CY 2014 Interim Final Work RVUs Considered by the Refinement Panel

    We referred to the CY 2014 refinement panel 19 CPT codes with CY 2014 interim final work values for which we received a request for refinement that met the requirements described above. For these 19 CPT codes, all commenters requested increased work RVUs. For ease of discussion, we will be referring to these services as ``refinement codes.'' Consistent with the process described above, we convened a multi-specialty panel of physicians to assist us in the review of the information submitted to support increased work RVUs. The panel was moderated by our physician advisors, and consisted of the following voting members:

    One to two clinicians representing the commenting organization.

    One to two primary care clinicians nominated by the American Academy of Family Physicians and the American College of Physicians.

    Four Contractor Medical Directors (CMDs).

    One to two clinicians with practices in related specialties, who were expected to have knowledge of the services under review.

    The panel process was designed to capture each participant's independent judgment and his or her clinical experience which informed and drove the discussion of the refinement code during the refinement panel proceedings. Following the discussion, each voting participant rated the work of the refinement code(s) and submitted those ratings to CMS directly and confidentially. We note that not all voting participants voted for every CPT code. There was no attempt to achieve consensus among the panel members. As finalized in the CY 2011 PFS final rule with comment period (75 FR 73307), we calculated the median value for each service based upon the individual ratings that were submitted to CMS by panel participants.

    Table 14 presents information on the work RVUs for the refinement codes, including the refinement panel ratings and the final CY 2015 work RVUs. In section II.G.2.a.ii., we discuss the CY 2015 work RVUs assigned each of the individual refinement codes.

    Table 14--Codes Reviewed by the 2014 Multi-Specialty Refinement Panel

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

    CY 2014 RUC Refinement

    HCPCS Code Descriptor interim final recommended panel median CY 2015 work

    work RVU work RVU rating RVU

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

    19081.......... Biopsy of breast accessed 3.29 3.29 3.40 3.29

    through the skin with

    stereotactic guidance.

    19082.......... Biopsy of breast accessed 1.65 1.65 1.78 1.65

    through the skin with

    stereotactic guidance.

    19083.......... Biopsy of breast accessed 3.10 3.10 3.10 3.10

    through the skin with

    ultrasound guidance.

    19084.......... Biopsy of breast accessed 1.55 1.55 1.55 1.55

    through the skin with

    ultrasound guidance.

    19085.......... Biopsy of breast accessed 3.64 3.64 3.64 3.64

    through the skin with MRI

    guidance.

    19086.......... Biopsy of breast accessed 1.82 1.82 1.82 1.82

    through the skin with MRI

    guidance.

    Page 67612

    19281.......... Placement of breast 2.00 2.00 2.00 2.00

    localization devices accessed

    through the skin with

    mammographic guidance.

    19282.......... Placement of breast 1.00 1.00 1.00 1.00

    localization devices accessed

    through the skin with

    mammographic guidance.

    19283.......... Placement of breast 2.00 2.00 2.00 2.00

    localization devices accessed

    through the skin with

    stereotactic guidance.

    19284.......... Placement of breast 1.00 1.00 1.00 1.00

    localization devices accessed

    through the skin with

    stereotactic guidance.

    19285.......... Placement of breast 1.70 1.70 1.70 1.70

    localization devices accessed

    through the skin with

    ultrasound guidance.

    19286.......... Placement of breast 0.85 0.85 0.85 0.85

    localization devices accessed

    through the skin with

    ultrasound guidance.

    19287.......... Placement of breast 2.55 3.02 3.02 2.55

    localization devices accessed

    through the skin with MRI

    guidance.

    19288.......... Placement of breast 1.28 1.51 1.51 1.28

    localization devices accessed

    through the skin with MRI

    guidance.

    43204.......... Injection of dilated esophageal 2.40 2.89 2.77 2.40

    veins using an endoscope.

    43205.......... Tying of esophageal veins using 2.51 3.00 2.88 2.51

    an endoscope.

    43213.......... Dilation of esophagus using an 4.73 5.00 5.00 4.73

    endoscope.

    43233.......... Balloon dilation of esophagus, 4.05 4.45 4.26 4.26

    stomach, and/or upper small

    bowel using an endoscope.

    43255.......... Control of bleeding of 3.66 4.20 4.20 3.66

    esophagus, stomach, and/or

    upper small bowel using an

    endoscope.

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

    (ii) Code-Specific Issues

    For each code with an interim final work value, Table 15 lists the CY 2014 interim final work RVU and the CY 2015 work RVU and indicates whether we are finalizing the CY 2015 work RVU. For codes without a work RVU, the table includes a PFS procedure status indicator. A list of the PFS procedure status indicators can be found in Addendum A. If the CY 2015 Action column indicates that the CY 2015 values are interim final, we will accept public comments on these values during the public comment period for this final rule with comment period. A comprehensive list of all values for which public comments are being solicited is contained in Addendum C to the CY 2015 PFS final rule with comment period. A comprehensive list of all CY 2015 RVUs is in Addendum B to this final rule with comment period. All Addenda to PFS final rule are available on the CMS Web site under downloads at http://www.cms.gov/physicianfeesched/PFSFederalRegulationNotices.html/. The time values for all codes are listed in a file called ``CY 2015 PFS Work Time,'' available on the CMS Web site under downloads for the CY 2015 PFS final rule with comment period at http://www.cms.gov/physicianfeesched/downloads/.

    BILLING CODE 4120-01-P

    Page 67613

    GRAPHIC TIFF OMITTED TR13NO14.000

    Page 67614

    GRAPHIC TIFF OMITTED TR13NO14.001

    Page 67615

    GRAPHIC TIFF OMITTED TR13NO14.002

    Page 67616

    GRAPHIC TIFF OMITTED TR13NO14.003

    Page 67617

    GRAPHIC TIFF OMITTED TR13NO14.004

    Page 67618

    GRAPHIC TIFF OMITTED TR13NO14.005

    Page 67619

    GRAPHIC TIFF OMITTED TR13NO14.006

    Page 67620

    GRAPHIC TIFF OMITTED TR13NO14.007

    Page 67621

    GRAPHIC TIFF OMITTED TR13NO14.008

    Page 67622

    GRAPHIC TIFF OMITTED TR13NO14.009

    Page 67623

    GRAPHIC TIFF OMITTED TR13NO14.010

    Page 67624

    GRAPHIC TIFF OMITTED TR13NO14.011

    Page 67625

    GRAPHIC TIFF OMITTED TR13NO14.012

    Page 67626

    GRAPHIC TIFF OMITTED TR13NO14.013

    Page 67627

    GRAPHIC TIFF OMITTED TR13NO14.014

    Page 67628

    GRAPHIC TIFF OMITTED TR13NO14.015

    Page 67629

    GRAPHIC TIFF OMITTED TR13NO14.016

    Page 67630

    GRAPHIC TIFF OMITTED TR13NO14.017

    Page 67631

    GRAPHIC TIFF OMITTED TR13NO14.018

    BILLING CODE 4120-01-C

    In the following section, we discuss each code for which we received a comment on the CY 2014 interim final work value or work time during the comment period for the CY 2014 final rule with comment period or for which we are modifying the CY 2014 interim final work RVU, work time or procedure status indicator for CY 2015. If a code in Table 15 is not discussed in this section, we did not receive any comments on that code and are finalizing the interim final work RVU and time without modification for CY 2015.

    (1) Mohs Surgery (CPT Codes 17311 and 17313)

    As detailed in the CY 2014 PFS final rule with comment period, we maintained the CY 2013 work RVUs for CPT codes 17311 and 17313 codes, based upon the RUC-recommended work RVUs.

    Comment: We received a comment that was supportive of the interim final work RVU.

    Response: We thank the commenter for their support and are finalizing the CY 2014 interim final values for CY 2015.

    (2) Breast Biopsy (CPT Codes 19081, 19082, 19083, 19084, 19085, 19086, 19281, 19282, 19283, 19284, 19285, 19286, 19287, and 19288)

    For CY 2014, the CPT Editorial Panel created 14 new codes, CPT codes 19081 through 19288, to describe breast biopsy and placement of breast localization devices, and the RUC recommended work RVUs for each of these codes. In the 2014 final rule with comment period, we established interim final values for all of these codes as recommended by the RUC except for CPT code 19287 and its add-on CPT code, 19288, which are used for magnetic resonance (MR) guidance. We expressed concern that for CPT code 19287 the RUC-recommended work RVUs were too high in relation to those of other marker placement codes, and refined it to a lower value. Since we had adopted the RUC recommendation that all the add-on codes in this family have work RVUs equal to 50 percent of the base code's work RVU, our refinement of CPT code 19287 resulted in a refinement of CPT code 19288 also. We also changed the intraservice time of CPT code 19286, an add-on code, from 19 minutes to 15 minutes since we believed the intraservice time of an add-on code should not be higher than its base code and the base code for CPT code 19286, has an intraservice time of 15 minutes.

    Comment: Several commenters disagreed with the new CPT coding structure for breast biopsy and placement of breast localization devices because, unlike the predecessor structure, it fails to distinguish between the two types of biopsy devices--standard core needle and vacuum assisted. One commenter suggested that the payment should be higher when services are vacuum assisted, and suggested that CMS create a modifier to report when these services are furnished using a vacuum assisted biopsy or create a series of G-codes that distinguish between standard core needle biopsy and vacuum assisted biopsy.

    Response: We prefer to use the CPT coding structure unless a programmatic need suggests that an alternative coding structure is preferable. In this case, we believe that we can pay appropriately for these services using the new CPT coding structure. To the extent that the commenters think the CPT coding system is not ideal for these services, we believe the CPT Editorial Panel is the appropriate forum for this concern. The commenters are mistaken regarding how the inputs for these codes were determined as they are based upon the typical service being vacuum assisted.

    Comment: Several commenters disagreed with the interim final work RVUs we established for CPT codes 19287 and 19288, stating that the higher RUC-recommended RVUs were more appropriate and would maintain relativity within the family. The commenters stated that these services have longer intraservice time than other codes in the marker placement family, are of high intensity, produce high patient and family anxiety, and have higher malpractice costs. One commenter requested that the entire breast biopsy code family be referred to refinement. Other commenters requested refinement panel review of selected codes within this family.

    Response: Based upon this request, we referred this family of codes to the CY 2014 multi-specialty refinement panel for further review. Prior to CY

    Page 67632

    2014, breast biopsies and marker placements were billed using a single code. In addition, the appropriate image guidance code was separately billed. Prior to CY 2014, there were individual guidance codes for the different types of guidance including MR and stereotactic guidance.

    For CY 2013, the MR guidance code, CPT code 77032, had a lower work RVU than the stereotactic guidance code, CPT code 77031. Combining the values for the marker placement or biopsy codes with the guidance codes should not, in our view, result in a change in the rank order of the guidance. Accordingly, we do not believe the bundled code that includes MR guidance should now be valued significantly higher than one that includes the stereotactic guidance. Also, the refinement panel discussions did not provide new clinical information. Therefore, we continue to believe the CY 2014 interim final values are appropriate for CPT codes 19287 and 19288, and are finalizing them for CY 2015.

    Comment: Commenters stated that the RUC-recommended intraservice time of 19 minutes for CPT code 19286, which is an add-on code, was incorrect and that the code should have the same intraservice time as its base code (15 minutes) rather than the 14 minutes assigned by CMS. The commenter said that this was consistent with the other base code/

    add-on relationships across the family.

    Response: We agree and are finalizing the intraservice time for CPT code 19286 at 15 minutes.

    Comment: In response to our request for confirmation that a post procedure mammogram is typically furnished with a breast marker placement procedure, commenters agreed that it was. However, they disagreed with our assertion that if it was typical it should be bundled with the appropriate breast marker procedures. Commenters said that it should be a separately reportable service because it requires additional work not captured by the codes in this family.

    Response: We thank commenters for their feedback. We are not bundling post procedure mammograms with the appropriate breast marker codes at this time, but will consider whether as a services that typically occur together they should be bundled.

    (3) Hip and Knee Replacement (CPT Codes 27130, 27446 and 27447)

    In the CY 2014 final rule with comment period we established interim final values for three CPT codes for hip and knee replacements that had previously been identified as potentially misvalued codes under the CMS high expenditure procedural code screen. For CY 2014, we established the RUC-recommended work value of 17.48 as interim final work RVUs for CPT code 27446. As we explained in the CY 2014 final rule with comment period, we established interim final work RVUs for CPT codes 27130 and 27447 that varied from those recommended by the RUC based upon information that we received from the relevant specialty societies. We noted that the information presented by the specialty societies and the RUC raised concerns regarding the appropriate valuation of these services, especially related to the use of the best data source for determining the intraservice time involved in furnishing PFS services. Specifically, there was significant variation between the time values estimated through a survey versus those collected through specialty databases. We characterized our concerns saying, ``The divergent recommendations from the specialty societies and the RUC regarding the accuracy of the estimates of time for these services, including both the source of time estimates for the procedure itself as well as the inpatient and outpatient visits included in the global periods for these codes, lead us to take a cautious approach in valuing these services.''

    With regard to the specific valuations, we agreed with the RUC's recommendation to value CPT codes 27130 and 27447 equally. We explained that we modified the RUC-recommended work RVUs for these two codes to reflect the visits in the global period as recommended by the specialty societies, resulting in a 1.12 work RVU increase from the RUC-

    recommended value for each code. Accordingly, we assigned CPT codes 27130 and 27447 an interim final work RVU of 20.72. We sought public comment regarding, not only the appropriate work RVUs for these services, but also the most appropriate reconciliation for the conflicting information regarding time values for these services as presented to us by the physician community. We also sought public comment on the use of specialty databases as compared to surveys for determining time values, potential sources of objective data regarding procedure times, and levels of visits furnished during the global periods for the services described by these codes.

    Comment: The RUC submitted comments explaining how it reached its recommendations for these codes and that it followed its process consistently in developing its recommendations on these codes. All those who commented specifically on the interim final work RVUs for these codes objected to the interim final work RVUs--some citing potential access problems. Commenters suggested that we use more reliable time data. Commenters suggested that valuation should be based on actual time data, which demonstrates that the time for this code has not changed since the last valuation; and thus the work RVUs should not decrease from the CY 2013 values. Among the commenters' suggestions were using data from the Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR), which includes data on more than 15,000 total lower extremity joint arthroplasty procedures, including time in/time out data for at least half of the procedures, and working with the specialty societies to explore the best data collection methods. A commenter suggested restoring the CY 2013 work RVUs until additional time data are available. Another commenter suggested valuing these services utilizing a reverse building block methodology resulting in work RVU of 21.18 for CPT codes 27130 and 22.11 for CPT code 27447. A commenter stated that the hip and knee replacement codes should be valued differently since they are clinically different procedures. Two commenters expressed concern regarding the use of a final rule to establish interim values for established hip and knee procedures due to the lack of opportunity it provides stakeholders to analyze and comment on reductions prior to implementation.

    Response: In the CY 2014 final rule with comment period, we noted concerns about the time data used in valuing these services and requested additional input from stakeholders regarding using other sources of data beyond the surveys typically used by the RUC. We do not believe that we received the kind of information and the level of detail about the other types of data suggested by commenters that we would need to be able to use routinely in valuing procedures. We will continue to explore the use of other data on time. As we discuss in section II.B. we have engaged contractors to assist us in exploring alternative data sources to use in determining the times associated with particular services. At this time, we are not convinced that data from another source would result in an improved value for these services. Nor did we find the reasons given for modifying the interim final work values established in CY 2014. The interim final values are based upon the best data we have available and preserve appropriate relativity with other codes.

    Page 67633

    Accordingly, we are finalizing the interim final values for these procedures.

    (4) Transcatheter Placement Intravascular Stent (CPT Code 37236, 37237, 37238, and 37239)

    For CY 2014, we established the RUC-recommended work RVUs for newly created CPT codes 37236, 37237, and 37238 as the interim final values. We disagreed with the RUC-recommended work RVU for CPT code 37239, which is the add-on code to CPT code 37238, for the placement of an intravascular stent in each additional vein. As we described in the CY 2014 final rule with comment period we believe that the work for placement of an additional stent in a vein should bear the same relationship to the work of placing an initial stent in the vein as the placement of an additional stent in an artery to the placement of the initial stent in an artery.

    Comment: Many commenters indicated that our valuation of CPT code 37239 was inappropriate. They indicated that instead we should use the RUC's recommended work RVU of 3.34 for this code since the procedure is more intense and requires more physician work than would result from the comparison made by CMS. One commenter requested that CPT code 37239 be referred to the refinement panel.

    Response: After re-review, we continue to believe that the ratio of the work of the placement of the initial stent to the placement of additional stents is the same whether the stents are placed in an artery or a vein, and accordingly the appropriate ratio is found in the RUC-recommended work RVUs of CPT codes 37236 and 37237, the comparable codes for the arteries. For that reason, we are finalizing our CY 2014 interim final values. Additionally, we did not refer these codes for refinement panel review because the criteria for refinement panel review were not met.

    (5) Embolization and Occlusion Procedures (CPT Codes 37242 and 37243)

    For CY 2014, we established interim final work RVUs for these two codes based upon the survey's 25th percentile. As we discussed in the CY 2014 interim final rule with comment period, we believed that the RUC-recommended work RVU for CPT code 37242 did not adequately take into account the substantial decrease in intraservice time. We indicated that we believed that the survey's 25th percentile work RVU of 10.05 was more consistent with the decreases in intraservice time since its last valuation and more appropriately reflected the work of the procedure. Similarly, we did not believe that the RUC-recommended work RVU for CPT code 37243 adequately considered the substantial decrease in intraservice time for the procedure; and we also use the survey's 25th percentile for CPT code 37243.

    Comment: Many commenters disagreed with our interim final valuation of 37242, including one who recommended a work RVU of 11.98. One commenter also believed the work RVU assigned to CPT code 37243 was inappropriate and recommended instead a work RVU of 14.00. Commenters requested that the family of codes be referred for refinement.

    Response: After consideration of the comments, we continue to believe that work RVUs should reflect the decreases in intraservice time that have occurred since the last valuation. As a result, we continue to believe that our CY 2014 interim final values are most appropriate and are finalizing them for CY 2015. Additionally, we did not refer these codes for refinement panel review because the criteria for refinement panel review were not met.

    (6) Rigid Transoral Esophagoscopy (CPT Codes 43191, 43192, 43193, 43194, 43195 and 43196)

    We established CY 2014 interim final work RVUs for the rigid transoral esophagoscopy codes using a ratio of 1 RVU per 10 minutes of intraservice time, resulting in a RVU of 2.00 for CPT code 43191, 3.00 for CPT code 43193, 3.00 for CPT code 43194, 3.00 for CPT code 43195, and 3.30 for CPT code 43196. As we detailed in the CY 2014 final rule with comment period, the surveys showed that this ratio was reflected for about half of the rigid transoral esophagoscopy codes. Additionally, we noted that this ratio was further supported by the relationship between the CY 2013 work value of 1.59 RVUs for CPT code 43200 (Esophagoscopy, rigid or flexible; diagnostic, with or without collection of specimen(s) by brushing or washing (separate procedure)) and its intraservice time of 15 minutes. For CPT code 43192, the 1 work RVU per 10 minutes ratio resulted in a value that was less than the survey low, and thus did not appear to be appropriate for this procedure. Therefore, we established a CY 2014 interim final work RVU for CPT code 43192 of 2.45 based upon the survey low.

    Comment: Multiple commenters objected to the interim final work RVUs assigned to CPT codes 43191-43196, and expressed dissatisfaction with CMS's explanation for the valuations. The commenters specifically noted that CMS did not account for the difference in intensity between flexible and rigid scopes now that there are separate codes for these procedures. The commenters also suggested that the reduction in time in the RUC recommendations for codes 43191, 43193, 43195, and 43196 was also based on data from procedures with flexible scopes. The commenters also stated that our valuation of services based upon 1 work RVU per 10 minutes of intraservice time was inappropriate and was based on the survey low, which is an anomalous outlier. The commenters suggested the following work RVUs based upon the RUC recommended values: 2.78 For CPT code 43191, 3.21 for CPT code 43192, 3.36 for CPT code 43193, 3.99 for CPT code 43194, 3.21 for CPT code 43195 and 3.36 or CPT code 43196. Finally, the commenters asked that all these codes be referred to a refinement panel for reconsideration.

    Response: After consideration of the comments, we agree that modification of the CY 2014 interim final values is appropriate. Based upon the information provided in comments and further investigation, we believe that greater intensity is involved in furnishing rigid than flexible transoral esophagoscopy. Accordingly, rather than assigning 1 work RVU per 10 minutes of intraservice time as we did for the CY 2014 interim final, we are assigning a final work RVU to the base code, CPT code 41391, of 2.49. This work RVU is based on increasing the work RVU of the previous comparable code (1.59) to reflect the percentage increase in time for the CY 2014 code. For the remaining rigid esophagoscopy codes, we developed RVUs by starting with the RVUs for the corresponding flexible esophagoscopy codes, and increasing those values by adding the difference between the base flexible esophagoscopy and the base rigid esophagoscopy codes to arrive at final RVUs. We are establishing a final work RVU of 2.79 to CPT code 43192, 2.79 to CPT code 43193, 3.51 to CPT code 43194, 3.07 to CPT code 43195, and 3.31 to CPT code 43196. These codes were not referred to refinement because the request did not meet the criteria for referral.

    (7) Flexible Transnasal Esophagoscopy (CPT Codes 43197 and 43198)

    We established CY 2014 interim final work RVUs of 1.48 for CPT code 43197 and 1.78 for CPT code 43198. As detailed in the CY 2014 final rule with comment period, we removed 2 minutes

    Page 67634

    of the pre-scrub, dress and wait preservice time from the calculation of the work RVUs that we established for CY 2014 for CPT codes 43200 and 43202 because we believed that unlike the transoral codes, which they correspond to, the transnasal services are not typically furnished with moderate sedation.

    Comment: Multiple commenters objected to the work RVUs for these codes and in particular to CMS basing its valuation on the fact that these codes typically do not involve moderate sedation. Although the commenters agreed that these codes typically do not involve moderate sedation, they said that procedures involving local/topical anesthesia often take more work than those involving general sedation due to the difficulties of furnishing services to a conscious and often anxious patient. Some also noted that it ignores the time necessary to apply local/topical anesthesia and wait for it to take effect. A commenter urged CMS to establish values based upon the RUC recommendations. Commenters requested that these codes be referred for refinement.

    Response: After consideration of the comments, we agree that the work RVUs for these codes should not be reduced because moderate sedation is not typically used. Accordingly, we agree with the RUC recommendation to assign the same work RVUs to these codes as to CPT code 43200 (Esophagoscopy, flexible, transoral; diagnostic, including collection of specimen(s) by brushing or washing when performed) and 43202 (Esophagoscopy, flexible, transoral; with biopsy, single or multiple) the comparable transoral codes. We are finalizing work RVUs of 1.52 and 1.82 for CPT codes 43197 and 43198, respectively. We did not refer these codes to refinement because the request did not meet the criteria for refinement panel review.

    (8) Flexible Transoral Esophagoscopy, (CPT Codes 43200, 43202, 43204, 43205, 43211, 43212, 43213, 43214, 43215, 43227, 43229, 43231, and 43232)

    We established CY 2014 interim final work RVUs for the flexible transoral esophagoscopy family, which are detailed in Table 15. As we described in the CY 2014 final rule with comment period, to establish work values for these codes we used a variety of methodologies as did the RUC. The methodologies used by CMS And the RUC include basing values on the surveys (either medians or 25th percentiles), crosswalking values to other codes, using the building block methodology, and valuing a family of codes based on the incremental differences in the work RVUs between the codes being valued and another family of codes. As we did for the rigid transoral esophagoscopy codes, in addition to the methodologies used by the RUC, we also reduced the work RVUs for particular codes in direct proportion to the reduction in times that were recommended by the RUC. Using these methodologies, we assigned the RUC-recommended work RVUs for five codes in this family; for the other eight codes we used these same methodologies but because of different values for a base code or variation in the crosswalk selected we obtained different values.

    Comment: Commenters objected to the interim final RVUs we assigned for CPT code 43200, the base code for flexible transoral esophagoscopy, because they did not believe the work RVU for the code should be less than they were as of CY 2013 when there was a single code to report both flexible and rigid esophagoscopy services. Commenters also disagreed with the way we used standard methodologies to value many of these codes, including using the ratio of 1 work RVU per 10 minutes of intraservice time to CPT code 43200. Commenters requested that we accept the RUC values for all the flexible transoral esophagoscopy codes and asked that we refer all these codes to the refinement panel.

    Response: Although refinement was requested for all of the flexible transoral esophagoscopy codes, we found that the codes (CPT codes 43204, 43205 and 43233) met the refinement criteria, and those were referred to the refinement panel. After consideration of the comments and the refinement panel results, we are revising the work RVUs for many of the codes in this family.

    For CPT code 43200, which is the base code for flexible transoral esophagoscopy, we agree with commenters that another methodology is preferable to applying the work RVU ratio of 1 RVU per 10 minutes of intraservice time. In revaluing this service, we subtracted 0.07 to account for the 3 minute decrease in postservice time since the last valuation from the CY 2013 work RVU for the predecessor base code, which resulted in a work RVU of 1.52. We are finalizing this work RVU.

    The CY 2014 interim final work RVUs for CPT codes 43201, 43202, 43204, 43205 and 43215 were all based upon methodologies using the work RVU of the base code, 43200. As we are establishing a final value for CPT code 43200 that is higher than the CY 2014 interim final value, we are also adjusting the work RVUs for the other codes based upon the new work RVU for CPT code 43200. We are finalizing a work RVU of 1.82 for 43201, 1.82 for 43202, 2.43 for 43204, 2.54 for 43205, and 2.54 for 43215.

    CPT codes 43204 and 43205 were considered by the refinement panel. The refinement panel median for each of these codes was 2.77 and 2.88, respectively. The refinement panel discussion reiterated the information presented to the RUC and in the comments in response to the CY 2014 final rule with comment period, such as that the typical patient for these codes are sicker and thus the work is more intense. Because we do not agree with commenters' contention that higher work RVUs are warranted since these codes involve the sicker patients or that our methodology for calculating the interim final RVUs was inappropriate, we are establishing final values determined using these methodologies. However, due to the change in the base code, CPT code 43200, as discussed in the previous paragraph the final values for these codes are higher than the interim final values.

    In the CY 2014 final rule with comment period, we assigned an interim final work RVU of 4.21 to CPT code 43211 by using a comparable esophagogastroduodenoscopy (EGD) code and subtracting the difference in work between the base esophagoscopy and base EGD codes. After consideration of the comments that indicated the interim final work RVU of 4.21 was too low, we believe this code should instead be crosswalked to CPT code 31636 (Bronchoscopy bronch stents), which we believe is a comparable service with comparable intensity. It has the same intraservice time and slightly higher total time. As a result we are finalizing a work RVU of 4.30.

    As we noted in the CY 2014 final rule with comment period, we crosswalked the interim final work RVU for CPT 43212 to that of CPT code 43214. Since we are increasing the work RVU for CPT code 43214, we are also increasing the work RVU for CPT code 43212, which is consistent with comments that we had undervalued this procedure.

    As we detailed in the CY 2014 final rule with comment period, we based the work RVU of 4.73 for CPT code 43213 on the value of CPT code 43220, increased proportionately to reflect the longer intraservice time of CPT code 43213. The refinement panel median was 5.00 for this code. No new information was presented at the refinement panel. We continue to believe that 4.73 is the appropriate work RVU and are finalizing it.

    Page 67635

    Based upon the information presented by commenters about the typical patient and the advanced skills required for the procedure, we are changing our method of valuing CPT code 43214. We believe it should be crosswalked to CPT 52214 (cystoscopy), which we believe is similar in intensity. This results in a final work RVU of 3.50 as compared to an interim final of 3.38. This refinement also supports the belief made by commenters that the work of CPT code 43214 is greater than the interim final work RVU. Therefore, we are finalizing a work RVU of 3.50 for CPT code 43214.

    For CPT code 43227, we modified the CY 2013 work RVU to reflect the percentage decrease in intraservice time of 36 minutes to 30 minutes in the RUC recommendation to establish a CY 2014 interim final value of 2.99. The commenters stated that the survey validates the RUC recommendation of 3.26 and that the drop in intraservice time that upon which we based our change in the work RVU was inappropriate since the intraservice time had not really changed. They contend that the change was from moving the time for moderate sedation from intraservice to preservice. We disagree. We have no information from the RUC that leads us to believe that when the pre-service packages were developed several years ago and moderate sedation was explicitly recognized as a pre-

    service item that the RUC also intended CMS to assume that the intraservice times were no longer correct. We believe that our proposed valuation methodology is correct and thus are finalizing a work RUV of 2.99.

    Commenters, disagreeing with our crosswalk of CPT code 43229 to CPT code 43232, stated that the two codes were not comparable. We disagree. We continue to believe this crosswalk is appropriate as the times and intensities are quite similar. We note that the RUC also bases crosswalks on the comparability of time and intensity of codes and not on the clinical similarity of work. Thus, we will continue this crosswalk. However, as discussed below, we are refining the interim final value of CPT code 43232 to 3.59 and thus are finalizing the work RVU of 3.59 for CPT code 43229.

    For CPT code 43231, we added the work of an endobronchial ultrasound (EBUS) to the work of the base esophagoscopy code to arrive at our interim final value. The commenters disagreed with our approach, stating that the EBUS code is an add-on code and as such does not have pre- and postservice work. We agree that pre- and postservice work is not included in the EBUS code nor should it be for the ultrasound portion of the examination of esophagus. Therefore, we are finalizing a work RVU of 2.90.

    For CPT code 43232, the commenters stated our interim final value is too low and that the work involved in this code is appropriately reflected in the RUC recommendation. They objected to our basing the work RVU for 43232 on the difference between the RUC-recommended values for this code and CPT code 43231. We learned from the comments that the typical patient for this service has advanced cancer and agree that our interim final value may not represent the full extent of the work involved in this procedure. Therefore, we are crosswalking this code to CPT code 36595 (Mechanical removal of pericatheter obstructive material (eg, fibrin sheath) from central venous device via separate venous access), which has identical intraservice time, slightly less total time, and a slightly higher intensity and are finalizing a work RVU of 3.59.

    (10) Esophagogastroduodenoscopy (EGD) (CPT Codes 43233, 43235, 43236, 43237, 43238, 43239, 43242, 43244, 43246, 43247, 43249, 43253, 43254, 43255, 43257, 43259, 43266, and 43270.

    We established interim final work RVUs for various EGD codes in the CY 2014 final rule with comment period. In this section, we discuss the 18 EGD codes on which we received comments disagreeing with or making recommendations for changes in our interim final values. As we detailed in the CY 2014 final rule with comment period, we valued many of these codes by adding the additional work of an EGD to the comparable esophagoscopy (ESO) code. We determined the additional work of an EGD by subtracting the work RVU of CPT code 43200, the base ESO code, from the work of CPT code 43235, the base EGD code. For example, CPT code 43233 is an identical procedure to CPT code 43214 except that it uses EGD rather than ESO. We valued it by adding the additional work of EGD to the work RVU of CPT code 43214, resulting in an interim final work RVU of 4.05. We valued the additional work the same way the RUC did in its recommendations. The following EGD codes were valued in the same way using the code in parentheses as the corresponding ESO code: 43233 (43214), 43236 (43201), 43237 (43231), 43238 (43232), 43247 (43215), 43254 (43211), 43255 (43227), 43266 (43212), and 43270 (43229). In valuing CPT codes 43235, we agreed with the RUC recommended work RVU difference between this EGD base code and the esophagoscopy base code, CPT 43200 but applied the difference to our CY 2014 RVU values. In a similar fashion, in valuing CPT code 43242 we agreed with the RUC recommended methodology of which took the increment between CPT code 43238 and CPT code 43237 but we applied the difference to our CY 2014 values. In order to value other EGD codes, we crosswalked the services to similar procedures; specifically for CY 2014 we crosswalked CPT codes 43239 to 43236, 43246 to 43255, 43253 to 43242 and 43257 to 43238. We valued CPT codes 43244 and 43249 through acceptance of the RUC work RVU recommendation. Lastly, we valued CPT code 43259 by adjusting the CY 2013 work RVU to account for the CY 2014 RUC recommended reduction in total time.

    Comment: For all codes, commenters objected to our work RVUs and said that our reductions from the RUC recommendations were based on a decrease in intraservice time that did not reflect a change in the time required to furnish the procedures but rather only a change in which part of the procedure the RUC includes the moderate sedation time. Commenters disagree with our valuing CPT code 43233 based on the value of CPT code 43214, saying that CPT code 43233 is more intense due to the risk of perforation, and that the achalasia patients are at high risk and poor candidates for surgery. Commenters disagreed with our methodology for valuing CPT code 43235, and suggested that we use the RUC crosswalk to CPT code 31579, contending that the slight reductions in pre- and post-service times are consistent with the slight drop in the RUC-recommended RVU. For CPT code 43237, commenters also noted a rank order anomaly because the interim final work RVU for this code is the same as for CPT code 43251. Commenters said that the robust survey data on CPT code 43238 should override CMS decisions. With regard to CPT code 43239, commenters suggest that the survey is wrong and further point to the fact that our valuation results in the same value for CPT code 43239 as the base EGD code, which they state is not appropriate due to the additional work in CPT code 43239. Commenters disagreed with our value for CPT code 43242 stating that we inappropriately valued CPT code 43259, which we used in calculating the work RVUs for CPT code 43242. Commenters objected to our value of CPT code 43246 because they disagree with the work RVU for the code that it is crosswalked to, CPT code 43255. Commenters urged us to modify

    Page 67636

    our work RVU for CPT code 43247 to equal the RUC recommendation. For CPT code 43253, commenters did not disagree with the valuation approach, but disagreed with the valuation we had assigned to the base code, CPT code 43259, which affected the valuation of CPT code 43253. Comments indicated that they did not understand how the value of CPT code 43254 was derived. Commenters indicated that they disagreed with the reduction in the work in CPT code 43255 due to a decrease in time. They also cited that this was an emergency procedure in unstable patients and that it was more difficult to control bleeding in the stomach than in the esophagus. For CPT code 43257, commenters disagreed with our crosswalk to CPT code 43238 indicating that CPT code 43257 was more intense than CPT code 43238. Commenters acknowledged that reduced times should result in reduced work, but disagreed with our proportional reduction approach. Commenters agreed with our approach to valuing CPT code 43266, but disagreed with the valuation of the CPT code 43212, that we used as the base. With regard to CPT code 43270, commenters disagreed with using CPT code 43229 as the base.

    Response: For each of these codes, commenters were concerned that we did not accept the RUC-recommended values. Their common reasoning for urging us to accept the RUC-recommended values was that moderate sedation time had been removed from intraservice time and that these intraservice time changes should not result in a change in the RUC-

    recommended RVU. However, for CPT codes 43233, 43236, 43237, 43238, 43247, 43254, 43255, 43266, and 43270, we used the standard methodology described above for valuing EGD codes and did not base our values on the time change. Thus, any refinements to the RUC recommendations for the EGD codes are solely due to refinements in the ESO codes. We discussed our valuations of these codes in the previous section. Since we have finalized most of the ESO codes at higher levels than the CY 2014 interim final values, we are making corresponding increases in the EGD codes. Therefore, we are finalizing these codes at the following work RVUs: 43233 at 4.17, 43235 at 2.19, 43236 at 2.49, 43237 at 3.57, 43238 at 4.26, 43247 at 3.21, 43254 at 4.97, 43255 at 3.66, 43266 at 4.17, and 43270 at 4.26.

    CPT code 43233 was referred to the refinement panel and received a median work RVU of 4.26. As outlined above, we are finalizing a work RVU of 4.17 for CPT code 43233 at 4.17, which is higher than our interim value of 4.05, but consistent with our valuation of the other EGD codes. We do not believe that the comments provided at the refinement panel justify adoption of the higher median value.

    The interim final work value of CPT code 43239 was crosswalked to the work RVU of CPT code 43236. Since we increased the final work RVU from the interim final for this code, the final work RUV of CPT code 43239 increases to 2.49.

    (11) Endoscopic Retrograde Cholangiopancreatography (ERCP) (CPT Codes 43263, 43274, 43276, 43277 and 43278)

    In the CY 2014 final rule with comment period we established interim final work RVUs for several ERCP codes due to coding revisions. For all those codes not discussed in this section, we are finalizing the interim final work RVUs. For CPT code 43263, we established an interim final work RVU based upon a crosswalk to CPT code 43262. As we detailed in the CY 2014 final rule with comment period, we valued CPT codes 43274, 43276, and 43278 using the same formula that the RUC used in determining its recommendations, but substituting our interim final work RVUs for codes used in the formula for the RUC-recommended values. CPT code 43277 was valued using the survey 25th percentile.

    Comment: Commenters objected to our valuation of CPT 43263 based upon a crosswalk to CPT code 43262, saying that CPT 43263 is more intense and has greater risks than CPT code 43262. Commenters also indicated that we underestimated the intensity of CPT code 43276 indicating that CPT code 43276 typically involves replacing stents that are overgrown with cancerous tissues. They also said that we underestimated the intensity of CPT coded 43274 and 43277. Commenters further took issue with our valuing CPT code 43277 based upon the survey when most codes in this family were valued based upon the incremental formula. Commenters stated that CPT code 43278 is valued incorrectly because we did not correctly value CPT code 43229, which is used in the formula we used to value CPT code 43278.

    Response: After consideration of the comments, we continue to believe that CPT code 43263 is the appropriate crosswalk for CPT code 43262 and we are finalizing a work RVU of 6.60 for that code. With regard to CPT code 43274, we continue to believe the formula described in the CY 2014 final rule with comment period is the appropriate methodology. We are finalizing a work RVU of 8.58 for CPT code 43274 using the final values for the codes used in the formula and thus increasing the work RVU from the interim final value of 8.48. Similarly, we are finalizing a work RVU of 8.94 for CPT code 43276 based upon the formula described in the CY 2014 final rule with comment period adjusted for changes in the final work RVUs for values used in the formula. For CPT code 43277, we continue to believe the survey 25th percentile is appropriate. This valuation is supported by a drop in the intraservice time from the code it replaces. Thus, we are finalizing the interim final work RVU of 7.00. For CPT code 43278, we continue to believe use of the RUC formula for this code is most appropriate, and we are adjusting the work RVU to reflect final work RVUs for values used in the formula. The final work RVU for CPT code 43278 is 8.

    (12) Spinal Injections (CPT Codes 62310, 62311, 62318 and 62319)

    We proposed new work RVUs for these codes in the PFS proposed rule. (79 FR 40338-40339). See section II.B.3 for a discussion of the valuation of these codes, and a summary of public comments and our responses.

    (13) Laminectomy (CPT Codes 63045, 63046, 63047 and 63048)

    We established interim final work RVUs for CPT codes 63047 and 63048 for CY 2014. As we indicated in the CY 2014 final rule with comment period, we had identified CPT code 63047 as potentially misvalued through the high expenditure procedure code screen and the RUC included a recommendation for CPT code 63048. We noted that, to appropriately value these codes, we need to consider the other two codes in this family: CPT codes 63045 (Laminectomy, facetectomy and foraminotomy (unilateral or bilateral with decompression of spinal cord, cauda equina and/or nerve roots, eg, spinal or lateral recess stenosis), single vertebral segment; cervical) and 63046 (Laminectomy, facetectomy and foraminotomy (unilateral or bilateral with decompression of spinal cord, cauda equina and/or nerve roots, eg, spinal or lateral recess stenosis), single vertebral segment; thoracic). Although we did not receive recommendations for CPT codes 63045 and 63046, we established CY 2014 interim final work RVUs for CPT codes 63047 and 63048 of 15.37 and 3.47, respectively, based upon the RUC recommendations. We noted that we expected to review these values in concert with the RUC

    Page 67637

    recommendations for CPT codes 63045 and 63046 when we received them.

    Comment: Commenters questioned our determination that CPT codes 63047, 63048, 63045 and 63046 constituted a family, noting that CPT codes 63045 and 63046 require different work. Commenters questioned the value of resurveying this set of codes as a family since CPT codes 63045 and 63046 constitute a small percentage of the total volume of these codes. The survey of CPT codes 63047 and 63048 did not reveal significant change in the values of the codes, and the work involved in resurveying would be burdensome for those involved. One commenter urged us to withdraw our request to survey these codes.

    Response: We continue to believe that it is appropriate to value a family of codes together in order to maintain relativity. We also continue to believe that CPT codes 63045 and 63046 are indeed in the same family as CPT codes 63047 and 63048 due to similarity of service. We have received new RUC recommendations for CPT code 63045 and 63046, but did not receive them in time to include in this rule. As a result, we will finalize the interim work values for CPT codes 63047 and 63048 for CY 2015.

    (14) Chemodenervation of Muscles (CPT Codes 64616, 64617, 64642, 64643, 64644, and 64645)

    We assigned refined interim final work RVU values of 1.53 to CPT code 64616 and 1.90 to CPT code 64617. As detailed in the CY 2014 final rule with comment period, we refined the RUC-recommended work RVUs of 1.79 for CPT code 64616 and 2.06 for CPT code 64617 to reflect the deletion of an outpatient visit that was included in the predecessor code, CPT code 64613 (chemodenervation of muscle(s); neck muscle(s) (eg, for spasmodic torticollis, spasmodic dysphonia)). We also explained that since CPT code 64617, chemodenervation of the larynx, includes EMG guidance when furnished we determined the interim final work RVU by adding the work RVU for CPT code 95874 (Needle electromyography for guidance in conjunction with chemodenervation (List separately in addition to code for primary procedure)) to the CY 2013 work RVU for CPT 64616.

    For CY 2014, we assigned interim final work RVUs for CPT code 64643 and CPT code 64645 of 1.22 and 1.39, respectively. As we explained in the CY 2014 final rule with comment period, we refined the RUC-

    recommended work RVUs for these add-on codes by subtracting the RVUs to account for 19 minutes of pre-service time and the decrease in time for furnishing the add-on service. Additionally, we based the global period for these codes on the predecessor code, CPT code 64614 (chemodenervation of muscle(s); extremity and/or trunk muscle(s) (eg, for dystonia, cerebral palsy, multiple sclerosis)), which was deleted for CY 2014. Therefore, we assigned 10-day global periods to the services.

    Comment: Most commenters disagreed with the CY 2014 interim final work RVU valuations for CPT codes 64616, 64643, and 64645. One commenter stated that the work RVU for the predecessor code, CPT code 64614, did not take into account the full level of intensity, time, and work that it takes to perform the service. This commenter also disagreed with the times for this service. Several commenters disagreed with the valuation of CPT code 64616 saying that we ignored the RUC recommendation which was based on survey data and RUC deliberations and asked that we value the code based upon the RUC recommendation. Several commenters disagreed with the valuations for CPT codes 64643 and 64645 saying that CMS did not explain our valuation, ignored the fact that the RUC discounted the add-on codes based on the pre- and post-service time and did not articulate any basis for our valuation decision. Several commenters requested refinement of the codes in the chemodenervation family.

    Response: After consideration of the comments we are finalizing the interim final work RVUs and time for these codes. We continue to believe that our valuations for this family take into account the full level of intensity, time, and work that are required to furnish these services. Additionally, we disagree with commenters that we did not explain our valuation of CPT codes 64643 and 64645. In the CY 2014 final rule with comment period, we detail and thoroughly explain the methodology utilized to value CPT codes 64643 and 64645. Additionally, the request for refinement panel review was not granted as the criteria for refinement were not met.

    (15) Impacted Cerumen (CPT Code 69210)

    After it was identified as a potentially misvalued code pursuant to the CMS high expenditure screen, CPT code 69210, which describes removal of impacted cerumen, was revised from being applicable to ``1 or both ears'' to a unilateral code effective January 1, 2014. For Medicare purposes we limited the code to billing once whether it was furnished unilaterally or bilaterally because we believed the procedure would typically be furnished in both ears as the physiologic processes that create cerumen impaction likely would affect both ears. Similarly, we continued the CY 2013 value as our interim final CY 2014 value since for Medicare purposes the service was unchanged.

    Comment: Commenters requested that we allow CPT code 69210 to be billed twice when it is furnished bilaterally, consistent with code descriptor. Commenters stated that our assumption regarding the physiologic processes that create cerumen was flawed and requested we provide a clinical rationale and/or literature to support our claim. Lastly, the commenters requested guidance from the agency as to how best deal with this CPT code; specifically, if it should be sent to CPT for clarification or if not, that we provide further guidance as to how this procedure should be billed using the new code.

    Response: We continue to believe that the procedure will be furnished in both ears as the physiologic processes that create cerumen impaction likely would affect both ears. As a result, we will continue to allow only one unit of CPT 69210 to be billed when furnished bilaterally and are finalizing our CY 2014 interim final work RVU for this service.

    (16) Magnetic Resonance Imaging (MRI) Brain (CPT Codes 77001, 77002, and 77003)

    As detailed in the CY 2014 final rule with comment period, we agreed with the RUC-recommended values for CPT codes 77001, 77002 and 77003 but were concerned that the recommended intraservice times for all three codes was generally higher than the procedure codes with which they were typically billed. We sought additional public comment and input from the RUC and other stakeholders regarding the appropriate relationship between the intraservice time associated with fluoroscopic guidance and the intraservice time of the procedure codes with which they are typically billed.

    Comment: Some commenters disagreed with the concern expressed by CMS that the intraservice time for codes 77001, 77002 and 77003 is higher than the codes alongside which they are typically billed, as the commenters believed that the combinations being used to support this concern were not appropriate, and they requested additional examples to support its concern. The commenters believed that the concerns CMS expressed are unfounded and that we should assign work RVUs of 0.38, 0.54, and 0.60 for

    Page 67638

    CPT code 77001, 77002, and 77003, respectively.

    Response: We continue to have concerns regarding the appropriate relationship between the intraservice time associated with fluoroscopic guidance and the intraservice time of the procedure codes with which they are typically billed and will continue to study this issue. We are finalizing the CY 2014 interim final values for CY 2015.

    (17) Immunohistochemistry (CPT Codes 88342 and 88343 and HCPCS Codes G0461 and G0462)

    These codes were revised for CY 2015. For discussion of valuation for CY 2015, see section II.G.3.b.

    (18) Optical Endomicroscopy (Code 88375)

    As detailed in the CY 2014 final rule with comment period, we believed that the typical optical endomicroscopy case would involve only the endoscopist, and CPT codes 43206 and 43253 were valued to reflect this. Accordingly, we believed a separate payment for CPT code 88375 would result in double payment for a portion of the overall optical endomicroscopy service. Therefore, we assigned a PFS procedure status of I (Not valid for Medicare purposes. Medicare uses another code for the reporting of and the payment for these services) to CPT code 88375.

    Comment: Multiple commenters objected to CMS's decision to assign a PFS status indicator of ``I'' to code 88375, stating that the code already includes distinctions that would prevent a physician from billing the code when it would double count work. The commenters urge CMS to assign CPT code 88375 a Medicare status of A (Active Code), and to immediately publish RVUs associated with the service.

    Response: In our re-review of this procedure and consideration of the information provided by commenters, we believe the coding is adequate to avoid double payment for a portion of the service. Accordingly, we assigned a Medicare status indicator of A (Active). To value this service, we based the RVUs on those assigned to CPT code 88329, adjusted for the difference in intraservice time between the two codes. We are assigning a final work RVU of 0.91 for CPT code 88375 for CY 2015.

    (19) Speech Language (CPT Codes 92521, 92522, 92523 and 92524)

    In CY 2014, we assigned CY 2014 interim final work RVUs of 1.75 and 1.50 for CPT codes 92521 and 92522, respectively, as the HCPAC recommended. For CPT code 92523, we disagreed with the HCPAC-

    recommended work RVU of 3.36. We believed that the appropriate value for 60 minutes of work for the speech evaluation codes was reflected in CPT code 92522, for which the HCPAC recommended 1.50 RVUs. Because the intraservice time for CPT code 92523 was twice that for CPT code 92522, we assigned a work RVU of 3.0 to CPT code 92523. Similarly, since CPT codes 92524 and 92522 had identical intraservice time recommendations and similar descriptions of work we believed that the work RVU for CPT code 92524 should be the same as the work RVU for CPT code 95922. Therefore, we assigned a work RVU of 1.50 to CPT code 92524.

    Comment: Commenters disagreed with the interim final work RVUs assigned to CPT codes 92523 and 92524, saying they based on inaccurate assumptions. Commenters stated that survey respondents appropriately took time and effort into account when valuing CPT code 92523 but had difficulty using a time-based reference code to value the RVU of an untimed code like CPT code 92523. Commenters noted that the HCPAC acknowledged that the work of the second hour involved in CPT code 92523 is indeed more intense than the first hour. Additionally, commenters stated that the work RVU reduction of CPT code 92524 was arbitrary because it was based solely on intraservice time and failed to recognize the more difficult aspects of performing the service compared to that of CPT code 92522. Commenters requested reconsideration of CPT codes 92523 and 92524 through refinement panel review.

    Response: We believe that our interim final work RVU is most appropriate for these services. In the HCPAC recommendation for CPT code 92523 the affected specialty society stated that its survey results were faulty for this CPT code because those surveyed did not consider all the work necessary to perform the service. The commenters did not provide any information that demonstrates that our valuations fail to fully account for the intensity, work, and time required to perform these services. Therefore, we are finalizing our CY 2014 interim final values for CY 2015. We did not refer these codes to refinement because the request did not meet the criteria for refinement.

    (20) Percutaneous Transcatheter Closure (CPT Code 93582)

    As detailed in the CY 2014 final rule with comment period, we reviewed new CPT code 93582. Although the RUC compared this code to CPT code 92941 (percutaneous transluminal revascularization of acute total/

    subtotal occlusion during acute myocardial infarction, coronary artery or coronary), which has a work RVU of 12.56 and 70 minutes of intraservice time, it recommended a work RVU of 14.00, the survey's 25th percentile. We agreed with the RUC that CPT code 92941 is an appropriate comparison code and believed that due to the similarity in intensity and time that the codes should be valued with the same work RVU. Therefore, we assigned an interim final work RVU of 12.56 to CPT code 93582.

    Comment: One commenter disagreed with the work RVU valuation of CPT code 93582 because they believed it did not accurately reflect the intensity of the procedure, particularly in treating infants. The commenter stated that the RUC concluded that a 55 percent work differential exists between performing this service on a child versus an adult--a fact that they stated supports the higher work RVU recommended by the RUC. As a result, the commenter suggests we assign the RUC-recommended work RVU to CPT code 93582. A commenter requested referral to the refinement panel.

    Response: We continue to believe that CPT code 92941 is an appropriate comparison code to CPT code 93582 due to similarity in intensity and time and, as a result, the codes should be valued with the same work RVU. Therefore, we are finalizing our CY 2014 interim final work RVU of 12.56 to CPT code 93582 for CY 2015. We did not refer this code to refinement because the request did not meet the criteria for refinement.

    (21) Duplex Scans (CPT Codes 93925, 93926, 93880 and 93882)

    For CY 2014 we maintained the CY 2013 RVUs for CPT codes 93880 and 93882. We were concerned that the RUC-recommended values for CPT codes 93880 and 93882, as well as our final values for CPT codes 93925 (Duplex scan of lower extremity arteries or arterial bypass grafts; complete bilateral study) and 93926 (Duplex scan of lower extremity arteries or arterial bypass grafts; unilateral or limited study), did not maintain the appropriate relativity within the family and referred the entire family to the RUC to assess relativity among the codes and then recommend appropriate work RVUs. We also requested that the RUC consider CPT codes 93886 (Transcranial Doppler study of the intracranial arteries; complete study) and 93888 (Transcranial Doppler study of the

    Page 67639

    intracranial arteries; limited study) in conjunction with the duplex scan codes to assess the relativity between and among the codes.

    Comment: One commenter questioned why we did not include all duplex scan codes we determined to be part of the family in our original request to the RUC. Another commenter opposed our valuation approach and stated that we should not redefine the codes in this family and that we should reject the RUC recommendations.

    Response: The valuations for CPT codes 93880, 93882, 93925, 93926, 93886 and 93888 are included in this year's valuations in section II.G.3.b

    (22) Interprofessional Telephone/Internet Consultative Services (CPT Codes 99446, 99447, 99448 and 99449)

    In CY 2014 we assigned CPT codes 99446, 99447, 99448, and 99449 a PFS procedure status indicator of B (Bundled code. Payments for covered services are always bundled into payment for other services, which are not specified. If RVUs are shown, they are not used for Medicare payment). If these services are covered, payment for them is subsumed by the payment for the services to which they are bundled (for example, a telephone call from a hospital nurse regarding care of a patient) because Medicare pays for telephone consultations regarding beneficiary services as a part of other services furnished to the beneficiary.

    Comment: A commenter expressed concern that the services covered by codes 99446-99449 were bundled together, and that no RVUs were published for these codes. The commenter observed that CMS compares the services to contact between nurses and patients in justifying its decision to bundle the services in with other work, and stated that this comparison is inappropriate to use regarding consultation between physicians. The commenter also stated that these services are vital in providing specific specialty expertise in areas where timely face-to-

    face service is not a viable option. The commenter urged that the status of these services be changed to ``Active,'' or at least ``Non-

    covered,'' and that the RUC-recommended values for these services be published.

    Response: Medicare pays for telephone consultations regarding beneficiary services as part of other services furnished to a beneficiary. As a result, we continue to believe that CPT codes 99446- 99449 are bundled; and we are finalizing the PFS procedure status indicator of B for these codes for CY 2015.

  35. Finalizing CY 2014 Interim Direct PE Inputs

  36. Background and Methodology

    In this section, we address interim final direct PE inputs as presented in the CY 2014 PFS final rule with comment period and displayed in the final CY 2014 direct PE database available on the CMS Web site under the downloads at http://www.cms.gov/PhysicianFeeSched/PFSFRN/list.asp#TopOfPage.

    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. 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 and reflect our payment policies, we use those direct PE inputs to value a service. If not, we refine the 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.

    In the CY 2014 PFS final rule with comment period (78 FR 74242), we addressed the general nature of some of our common refinements to the RUC-recommended direct PE inputs, as well as the reasons for refinements to particular inputs. In the following sections, we respond to the comments we received regarding common refinements we made based on established principles or policies. Following those discussions, we summarize and respond to comments received regarding other refinements to particular codes.

    We note that the interim final direct PE inputs for CY 2014 that are being finalized for CY 2015 are displayed in the final CY 2015 direct PE input database, available on the CMS Web site under the downloads for the CY 2015 PFS final rule at www.cms.gov/PhysicianFeeSched/. The inputs displayed there have also been used in developing the CY 2015 PE RVUs as displayed in Addendum B of this final rule with comment period.

    Comment: Commenters indicated that it would be helpful to have additional information about the specific rationale used in developing refinements, and specifically requested that CMS provide more information regarding how CMS makes the determination of whether an item is typical.

    Response: We continually seek ways to increase opportunity for public comment. In response to comments received, we have provided more detailed explanations about refinements made for the CY 2015 interim final direct PE inputs. We recognize that we make assumptions about what is typical, and note that we welcome objective data that provides information about the typical case. We prefer that this information be submitted through the notice and comment rulemaking process. We also refer interested stakeholders to section II.F. of this final rule with comment period, in which we provide extensive discussion of the changes to the process that we are finalizing for valuing new, revised, and potentially misvalued codes.

    ii. Common Refinements

    (1) 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 times within the intra-service 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 services in which we allocate cleaning time to portable equipment items, because the equipment does not need to be cleaned in the room that contains the remaining equipment items, we do not include that time for the remaining equipment items as they are available for use for other patients during that time. In addition, when a piece of equipment is typically used during any additional 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

    Page 67640

    (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.

    Some commenters have repeatedly objected to our rationale for refinement of equipment minutes on this basis. We acknowledge the comments we received reiterating those objections to this rationale and refer readers to our extensive discussion in response to those objections in the CY 2012 PFS final rule with comment period (76 FR 73182). In the following paragraphs, we address new comments on this policy.

    Comment: A commenter indicated that CMS removed minutes assigned to vascular ultrasound rooms for activities that CMS does not believe take place in the room, but CMS did not provide factual support for this assumption. The commenter further stated that CMS did not articulate the connection between the relevant data that the Administrative Procedures Act (APA) requires CMS to consider and the conclusion that CMS reached. The commenter indicated that they conducted a survey of a significant number of providers, in which most providers indicated that they performed these pre-service tasks in the room.

    Response: We note that we would welcome comments that include vetted survey results, especially where the data are included. Statements regarding the existence of data to support commenters' assertions do not provide us with information to support conclusions based on the data. We acknowledge that we make assumptions about we believe to be typical. If there are data that support or refute these assumptions, we would be interested in reviewing that information. We would be most interested in reviewing survey data that address multiple points of our assumptions regarding high-cost equipment, including how many procedures are furnished in a day, how often the equipment is being used, and other such information.

    Comment: A commenter stated that CMS should publish, on a quarterly basis, refinements to the equipment times, rather than waiting until the final rule to publish these changes.

    Response: We appreciate the commenter's concern about our making available timely information about refinements to practice expense inputs. We note that since we do not review and make refinements to practice expense inputs on a quarterly basis, we do not have information to publish on a quarterly basis. Rather, we have reviewed and refined practice expense recommendations from the RUC on an annual basis for the subset of codes for which recommendations have been provided to us. Because we have received many requests from stakeholders to publish our refinements as proposals in the proposed rule rather than in the final rule, we are finalizing a change in the process in which changes to RVUs and direct PE inputs will be included in the proposed rule rather than first appearing in the final rule with comment period. We refer readers to section II.F. of this final rule with comment period for further information about this change. We believe that this process will address commenters' concerns about having an opportunity to review these changes prior to the publishing of the final rule.

    Comment: Several commenters asked that CMS identify what constitutes a highly technical piece of equipment.

    Response: As we have previously indicated, during our review of all recommended direct PE inputs, we consider such items as the degree of specificity of a piece of equipment, which may influence whether the equipment item is likely to be stored in the same room in which the clinical staff greets and gowns, obtains vitals, or provides education to a patient prior to the procedure itself. We would expect that items that are highly specific to particular procedures would be moved between rooms for those procedures. We also consider the level of portability (including the level of difficulty involved in cleaning the equipment item) to determine whether an item could be easily transferred between rooms before or after a given procedure. Items that are portable would also be expected to be moved between rooms. We also examine the prices for the particular equipment items to determine whether the equipment is likely to be located in the same room used for all the tasks undertaken by clinical staff prior to and following the procedure. We believe that highly expensive equipment would not be kept in a location that does not allow for its maximum utilization. For each service, on a case-by-case basis, we look at the description provided in the RUC recommendation and consider the overlap of the equipment item's level of specificity, portability, and cost; and, consistent with the review of other recommended direct PE inputs, we make the determination of whether the recommended equipment items are highly technical. We note that it is not practical to ensure that all of the existing equipment time in the database is allocated accordingly, but as we review any recommendations received from the RUC, we make this determination. To provide stakeholders with examples of the types of equipment items that are and are not considered highly technical, we have listed several items below and indicated whether they are highly technical.

    Table 16--Classification of Highly Technical Equipment

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

    Highly technical Not highly technical

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

    Item CMS code Price Item CMS code Price

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

    room, CT.............................. EL007.................... $1,284,000.00 Light, exam............. EQ168................... $1,630.12

    accelerator, 6-18 MV.................. ER010.................... 1,832,941.00 Table, exam............. EF023................... 1,338.17

    gamma camera system, single-dual head ER097.................... 600,272.00 Chair, medical recliner. EF009................... 829.03

    SPECT CT.

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

    (2) Standard Tasks and Minutes for Clinical Labor Tasks

    In general, the pre-service, service period, and post-service 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 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 to determine their appropriateness. When we do not accept

    Page 67641

    the RUC-recommended exceptions, we refine the interim final 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, 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.'' In these instances, CMS staff reviews these tasks to determine whether they are similar to tasks delineated for other services under the PFS. For those tasks that do not meet this criterion, we do not accept those clinical labor tasks as direct inputs.

    (3) Equipment Minutes for Film Equipment Inputs

    In section II.A. of this final rule with comment period, we finalize our proposal to accept the RUC recommendation to remove inputs associated with film technology that are associated with imaging services. We acknowledge comments received regarding the minutes allocated to equipment items associated with film technology; we will not address those comments below, because subsequent to the publication of the CY 2014 final rule with comment period, as discussed in section II.A. of this final rule with comment period, we finalized our proposal to remove these inputs from the Direct PE database, and thus the comments are no longer relevant.

    (4) Standard Inputs for Moderate Sedation

    In establishing interim final direct PE inputs for services that contain the standard moderate sedation input package, we refined the RUC's recommendation by removing the stretcher (EF018) and adjusting the standard moderate sedation equipment inputs to conform to the standard moderate sedation equipment times. These procedures are listed in Table 17.

    Comment: Commenters objected to our refinement of the standard moderate sedation equipment input times to conform to the moderate sedation equipment standard times, since it decreased the time allocated to these equipment items.

    Response: We note that for moderate sedation procedures, the equipment time is tied to the RN time rather than to the entire service period. Specifically, this time includes 2 minutes for sedate/apply anesthesia, 100 percent of physician intraservice time, and 60 minutes of post-procedure time for every 15 minutes of RN monitoring time. The times included in Table 17 reflect this standard. We note that for all procedures in Table 17 the times allocated to the equipment items that were interim final for 2014 were already consistent with the moderate sedation standard equipment times, with the exception of CPT code 37238, which was mistakenly allocated 257 minutes, when the correct time is actually 242 minutes.

    Comment: Commenters indicated that for office endoscopic procedures, the stretcher is typically used throughout the entire procedure, as well as during post-procedure monitoring. Other commenters indicated that the stretcher is required during the moderate sedation recovery time. The commenters requested that we include the stretcher for those procedures, and that we reduce the increased time allocated to the power table.

    Response: In section II.A. of this final rule with comment period, we finalized our proposal to modify the standard moderate sedation input package to include a stretcher for the same length of time as the other equipment items in the moderate sedation package. We indicated that the revised package would be applied to relevant codes as we review them through future notice and comment rulemaking. We have therefore refined those inputs to incorporate the stretcher for these codes listed in Table 17. Since we are incorporating the stretcher, we have removed the power table for procedures in which a power table was previously included. We will hold these procedures as interim final for CY 2015 due to the insertion of the stretcher and removal of the power table.

    We are therefore finalizing the PE inputs for the procedures containing the standard moderate sedation inputs, with the additional refinements of including the stretcher for all of these procedures, removing the power table for the codes noted in Table 17 as containing a power table, and adjusting the equipment time for CPT code 37238. We note that these changes are displayed in the final CY 2015 direct PE input database, available on the CMS Web site under the downloads for the CY 2015 PFS final rule at www.cms.gov/PhysicianFeeSched/.

    Table 17--CPT Codes With Stretcher Added

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

    Moderate

    CPT Code Short descriptor sedation Contained power table?

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

    10030............................ Guide cathet fluid drainage 152

    36245............................ Ins cath abd/l-ext art 1st. 167

    37236............................ Open/perq place stent 1st.. 332

    37238............................ Open/perq place stent same. 242

    37241............................ Vasc embolize/occlude 272

    venous.

    37242............................ Vasc embolize/occlude 342

    artery.

    37243............................ Vasc embolize/occlude organ 362

    37244............................ Vasc embolize/occlude bleed 332

    43200............................ Esophagoscopy flexible 77 Yes.

    brush.

    43201............................ Esoph scope w/submucous inj 80 Yes.

    43202............................ Esophagoscopy flex biopsy.. 82 Yes.

    43206............................ Esoph optical 92 Yes.

    endomicroscopy.

    43213............................ Esophagoscopy retro balloon 107 Yes.

    43215............................ Esophagoscopy flex remove 82 Yes.

    fb.

    43216............................ Esophagoscopy lesion 84 Yes.

    removal.

    43217............................ Esophagoscopy snare les 92 Yes.

    remv.

    43220............................ Esophagoscopy balloon 1 mev; 0.00 ............ I N/A

    simple.

    77407..... Radiation treatment delivery, >1 mev; 0.00 ............ I N/A

    intermediate.

    77412..... Radiation treatment delivery, >1 mev; 0.00 ............ I N/A

    complex.

    88341..... Immunohistochemistry or (\1\) 0.65 0.42 No

    immunocytochemistry, per specimen; each

    additional single antibody stain

    procedure (list separately in addition

    to code for primary procedure).

    88342..... Immunohistochemistry or I 0.70 0.70 No

    immunocytochemistry, per specimen;

    initial single antibody stain procedure.

    88344..... Immunohistochemistry or (\1\) 0.77 0.77 No

    immunocytochemistry, per specimen; each

    multiplex antibody stain procedure.

    88356..... Morphometric analysis; nerve............ 3.02 2.80 2.80 No

    88364..... In situ hybridization (eg, fish), per (\1\) 0.88 0.53 No

    specimen; each additional single probe

    stain procedure (list separately in

    addition to code for primary procedure).

    88365..... In situ hybridization (eg, fish), per 1.20 0.88 0.88 No

    specimen; initial single probe stain

    procedure.

    88366..... In situ hybridization (eg, fish), per (\1\) 1.24 1.24 No

    specimen; each multiplex probe stain

    procedure.

    88367..... Morphometric analysis, in situ 1.30 0.86 0.73 No

    hybridization (quantitative or semi-

    quantitative), using computer-assisted

    technology, per specimen; initial

    single probe stain procedure.

    88368..... Morphometric analysis, in situ 1.40 0.88 0.88 No

    hybridization (quantitative or semi-

    quantitative), manual, per specimen;

    initial single probe stain procedure.

    88369..... Morphometric analysis, in situ (\1\) 0.88 0.53 No

    hybridization (quantitative or semi-

    quantitative), manual, per specimen;

    each additional single probe stain

    procedure (list separately in addition

    to code for primary procedure).

    88373..... Morphometric analysis, in situ (\1\) 0.86 0.43 No

    hybridization (quantitative or semi-

    quantitative), using computer-assisted

    technology, per specimen; each

    additional single probe stain procedure

    (list separately in addition to code

    for primary procedure).

    88374..... Morphometric analysis, in situ (\1\) 1.04 0.93 No

    hybridization (quantitative or semi-

    quantitative), using computer-assisted

    technology, per specimen; each

    multiplex probe stain procedure.

    88377..... Morphometric analysis, in situ (\1\) 1.40 1.40 No

    hybridization (quantitative or semi-

    quantitative), manual, per specimen;

    each multiplex probe stain procedure.

    88380..... Microdissection (ie, sample preparation 1.56 1.14 1.14 No

    of microscopically identified target);

    laser capture.

    88381..... Microdissection (ie, sample preparation 1.18 0.53 0.53 No

    of microscopically identified target);

    manual.

    91200..... Liver elastography, mechanically induced (\1\) 0.30 0.30 No

    shear wave (eg, vibration), without

    imaging, with interpretation and report.

    Page 67660

    92145..... Corneal hysteresis determination, by air (\1\) 0.17 0.17 No

    impulse stimulation, unilateral or

    bilateral, with interpretation and

    report.

    92540..... Basic vestibular evaluation, includes 1.50 1.50 1.50 No

    spontaneous nystagmus test with

    eccentric gaze fixation nystagmus, with

    recording, positional nystagmus test,

    minimum of 4 positions, with recording,

    optokinetic nystagmus test,

    bidirectional foveal and peripheral

    stimulation, with recording, and

    oscillating tracking test, with

    recording.

    92541..... Spontaneous nystagmus test, including 0.40 0.40 0.40 No

    gaze and fixation nystagmus, with

    recording.

    92542..... Positional nystagmus test, minimum of 4 0.33 0.48 0.48 No

    positions, with recording.

    92543..... Caloric vestibular test, each irrigation 0.10 0.35 0.10 No

    (binaural, bithermal stimulation

    constitutes 4 tests), with recording.

    92544..... Optokinetic nystagmus test, 0.26 0.27 0.27 No

    bidirectional, foveal or peripheral

    stimulation, with recording.

    92545..... Oscillating tracking test, with 0.23 0.27 0.27 No

    recording.

    93260..... Programming device evaluation (in (\1\) 0.85 0.85 No

    person) with iterative adjustment of

    the implantable device to test the

    function of the device and select

    optimal permanent programmed values

    with analysis, review and report by a

    physician or other qualified health

    care professional; implantable

    subcutaneous lead defibrillator system.

    93261..... Interrogation device evaluation (in (\1\) 0.74 0.74 No

    person) with analysis, review and

    report by a physician or other

    qualified health care professional,

    includes connection, recording and

    disconnection per patient encounter;

    implantable subcutaneous lead

    defibrillator system.

    93282..... Programming device evaluation (in 0.85 0.85 0.85 No

    person) with iterative adjustment of

    the implantable device to test the

    function of the device and select

    optimal permanent programmed values

    with analysis, review and report by a

    physician or other qualified health

    care professional; single lead

    transvenous implantable defibrillator

    system.

    93283..... Programming device evaluation (in 1.15 1.15 1.15 No

    person) with iterative adjustment of

    the implantable device to test the

    function of the device and select

    optimal permanent programmed values

    with analysis, review and report by a

    physician or other qualified health

    care professional; dual lead

    transvenous implantable defibrillator

    system.

    93284..... Programming device evaluation (in 1.25 1.25 1.25 No

    person) with iterative adjustment of

    the implantable device to test the

    function of the device and select

    optimal permanent programmed values

    with analysis, review and report by a

    physician or other qualified health

    care professional; multiple lead

    transvenous implantable defibrillator

    system.

    93287..... Peri-procedural device evaluation (in 0.45 0.45 0.45 No

    person) and programming of device

    system parameters before or after a

    surgery, procedure, or test with

    analysis, review and report by a

    physician or other qualified health

    care professional; single, dual, or

    multiple lead implantable defibrillator

    system.

    93289..... Interrogation device evaluation (in 0.92 0.92 0.92 No

    person) with analysis, review and

    report by a physician or other

    qualified health care professional,

    includes connection, recording and

    disconnection per patient encounter;

    single, dual, or multiple lead

    transvenous implantable defibrillator

    system, including analysis of heart

    rhythm derived data elements.

    93312..... Echocardiography, transesophageal, real- 2.20 3.18 2.55 No

    time with image documentation (2d)

    (with or without m-mode recording);

    including probe placement, image

    acquisition, interpretation and report.

    93313..... Echocardiography, transesophageal, real- 0.95 1.00 0.51 No

    time with image documentation (2d)

    (with or without m-mode recording);

    placement of transesophageal probe only.

    93314..... Echocardiography, transesophageal, real- 1.25 2.80 2.10 Yes

    time with image documentation (2d)

    (with or without m-mode recording);

    image acquisition, interpretation and

    report only.

    93315..... Transesophageal echocardiography for C 3.29 2.94 No

    congenital cardiac anomalies; including

    probe placement, image acquisition,

    interpretation and report.

    93316..... Transesophageal echocardiography for 0.95 1.50 0.85 No

    congenital cardiac anomalies; placement

    of transesophageal probe only.

    93317..... Transesophageal echocardiography for C 3.00 2.09 Yes

    congenital cardiac anomalies; image

    acquisition, interpretation and report

    only.

    Page 67661

    93318..... Echocardiography, transesophageal (tee) C 2.40 2.40 No

    for monitoring purposes, including

    probe placement, real time 2-

    dimensional image acquisition and

    interpretation leading to ongoing

    (continuous) assessment of (dynamically

    changing) cardiac pumping function and

    to therapeutic measures on an immediate

    time basis.

    93320..... Doppler echocardiography, pulsed wave 0.38 0.38 0.38 No

    and/or continuous wave with spectral

    display (list separately in addition to

    codes for echocardiographic imaging);

    complete.

    93321..... Doppler echocardiography, pulsed wave 0.15 0.15 0.15 No

    and/or continuous wave with spectral

    display (list separately in addition to

    codes for echocardiographic imaging);

    follow-up or limited study (list

    separately in addition to codes for

    echocardiographic imaging).

    93325..... Doppler echocardiography color flow 0.07 0.07 0.07 No

    velocity mapping (list separately in

    addition to codes for echocardiography).

    93355..... Echocardiography, transesophageal (tee) (\1\) 4.66 4.66 No

    for guidance of a transcatheter

    intracardiac or great vessel(s)

    structural intervention(s) (eg, tavr,

    transcathether pulmonary valve

    replacement, mitral valve repair,

    paravalvular regurgitation repair, left

    atrial appendage occlusion/closure,

    ventricular septal defect closure)

    (peri- and intra-procedural), real-time

    image acquisition and documentation,

    guidance with quantitative

    measurements, probe manipulation,

    interpretation, and report, including

    diagnostic transesophageal

    echocardiography and, when performed,

    administration of ultrasound contrast,

    doppler, color flow, and 3d.

    93644..... Electrophysiologic evaluation of (\1\) 3.65 3.29 No

    subcutaneous implantable defibrillator

    (includes defibrillation threshold

    evaluation, induction of arrhythmia,

    evaluation of sensing for arrhythmia

    termination, and programming or

    reprogramming of sensing or therapeutic

    parameters).

    93880..... Duplex scan of extracranial arteries; 0.60 0.80 0.80 No

    complete bilateral study.

    93882..... Duplex scan of extracranial arteries; 0.40 0.50 0.50 No

    unilateral or limited study.

    93886..... Transcranial doppler study of the 0.94 1.00 0.91 No

    intracranial arteries; complete study.

    93888..... Transcranial doppler study of the 0.62 0.70 0.50 No

    intracranial arteries; limited study.

    93895..... Quantitative carotid intima media (\1\) 0.55 N No

    thickness and carotid atheroma

    evaluation, bilateral.

    93925..... Duplex scan of lower extremity arteries 0.80 0.80 0.80 No

    or arterial bypass grafts; complete

    bilateral study.

    93926..... Duplex scan of lower extremity arteries 0.50 0.60 0.50 No

    or arterial bypass grafts; unilateral

    or limited study.

    93930..... Duplex scan of upper extremity arteries 0.46 0.80 0.80 No

    or arterial bypass grafts; complete

    bilateral study.

    93931..... Duplex scan of upper extremity arteries 0.31 0.50 0.50 No

    or arterial bypass grafts; unilateral

    or limited study.

    93970..... Duplex scan of extremity veins including 0.70 0.70 0.70 No

    responses to compression and other

    maneuvers; complete bilateral study.

    93971..... Duplex scan of extremity veins including 0.45 0.45 0.45 No

    responses to compression and other

    maneuvers; unilateral or limited study.

    93975..... Duplex scan of arterial inflow and 1.80 1.30 1.16 No

    venous outflow of abdominal, pelvic,

    scrotal contents and/or retroperitoneal

    organs; complete study.

    93976..... Duplex scan of arterial inflow and 1.21 1.00 0.80 No

    venous outflow of abdominal, pelvic,

    scrotal contents and/or retroperitoneal

    organs; limited study.

    93978..... Duplex scan of aorta, inferior vena 0.65 0.97 0.80 No

    cava, iliac vasculature, or bypass

    grafts; complete study.

    93979..... Duplex scan of aorta, inferior vena 0.44 0.70 0.50 No

    cava, iliac vasculature, or bypass

    grafts; unilateral or limited study.

    93990..... Duplex scan of hemodialysis access 0.25 0.60 0.50 No

    (including arterial inflow, body of

    access and venous outflow).

    95971..... Electronic analysis of implanted 0.78 0.78 0.78 No

    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.

    Page 67662

    95972..... Electronic analysis of implanted 1.50 0.90 0.80 No

    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 1 hour.

    95973..... Electronic analysis of implanted 0.92 NA 0.49 No

    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).

    97605..... Negative pressure wound therapy (eg, 0.55 0.55 0.55 No

    vacuum assisted drainage collection),

    utilizing durable medical equipment

    (dme), including topical

    application(s), wound assessment, and

    instruction(s) for ongoing care, per

    session; total wound(s) surface area

    less than or equal to 50 square

    centimeters.

    97606..... Negative pressure wound therapy (eg, 0.60 0.60 0.60 No

    vacuum assisted drainage collection),

    utilizing durable medical equipment

    (dme), including topical

    application(s), wound assessment, and

    instruction(s) for ongoing care, per

    session; total wound(s) surface area

    greater than 50 square centimeters.

    97607..... Negative pressure wound therapy, (eg, (\1\) 0.41 C ................

    vacuum assisted drainage collection),

    utilizing disposable, non-durable

    medical equipment including provision

    of exudate management collection

    system, topical application(s), wound

    assessment, and instructions for

    ongoing care, per session; total

    wound(s) surface area less than or

    equal to 50 square centimeters.

    97608..... Negative pressure wound therapy, (eg, (\1\) 0.46 C Yes

    vacuum assisted drainage collection),

    utilizing disposable, non-durable

    medical equipment including provision

    of exudate management collection

    system, topical application(s), wound

    assessment, and instructions for

    ongoing care, per session; total

    wound(s) surface area greater than 50

    square centimeters.

    97610..... Low frequency, non-contact, non-thermal C 0.35 0.35 No

    ultrasound, including topical

    application(s), when performed, wound

    assessment, and instruction(s) for

    ongoing care, per day.

    99183..... Physician or other qualified health care 2.34 2.11 2.11 No

    professional attendance and supervision

    of hyperbaric oxygen therapy, per

    session.

    99184..... Initiation of selective head or total (\1\) 4.50 4.50 No

    body hypothermia in the critically ill

    neonate, includes appropriate patient

    selection by review of clinical,

    imaging and laboratory data,

    confirmation of esophageal temperature

    probe location, evaluation of amplitude

    eeg, supervision of controlled

    hypothermia, and assessment of patient

    tolerance of cooling.

    99188..... Application of topical fluoride varnish (\1\) 0.20 N N/A

    by a physician or other qualified

    health care professional.

    99487..... Complex chronic care management 1.00 1.00 B N/A

    services, 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;

    establishment or substantial revision

    of a comprehensive care plan; moderate

    or high complexity medical decision

    making; 60 minutes of clinical staff

    time directed by a physician or other

    qualified health care professional, per

    calendar month.

    99497..... Advance care planning including the (\1\) 1.50 I N/A

    explanation and discussion of advance

    directives such as standard forms (with

    completion of such forms, when

    performed), by the physician or other

    qualified health care professional;

    first 30 minutes, face-to-face with the

    patient, family member(s), and/or

    surrogate.

    Page 67663

    99498..... Advance care planning including the (\1\) 1.40 I N/A

    explanation and discussion of advance

    directives such as standard forms (with

    completion of such forms, when

    performed), by the physician or other

    qualified health care professional;

    each additional 30 minutes (list

    separately in addition to code for

    primary procedure).

    G0279..... Diagnostic digital breast tomosynthesis, (\1\) N/A 0.60 N/A

    unilateral or bilateral (list

    separately in addition to G0204 or

    G0206).

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

    \1\ New.

  37. Code Specific Issues

    (1) Internal Fixation of Rib Fracture (CPT Codes 21811, 21812 and 21813)

    For CY 2015, the CPT Editorial Panel deleted CPT code 21810 (Treatment of rib fracture requiring external fixation (flail chest)) and replaced it with three CPT codes 21811, 21812 and 21813, to report internal fixation of rib fracture. The RUC recommended valuing these three codes as 90-day global services. For the reasons we articulate in section II.B.4 of this final rule with comment period about the difficulties in accurately valuing codes as 90-day global services, we believe that the valuation of these codes should be as 0-day global services. In addition, we believe this is particularly appropriate for these codes because the number of RUC-recommended inpatient and outpatient visits included in the postservice time seems higher than would likely occur. The vignette for CPT code 21811 describes an elderly patient who falls and experiences three rib fractures that require internal fixation. The seven visits included in the postservice time for this code seem high since the vignette does not describe a very ill patient. The vignettes for CPT codes 21812 and 21813 describe patients experiencing significant rib fractures in car accidents that require internal fixation. We believe that in these scenarios, injuries beyond rib fractures are likely, and as a result, we believe it is likely that multiple practitioners would be involved in providing post-

    operative care. If other practitioners would furnish care in the post-

    surgery period, we believe the ten and thirteen postservice visits included in CPT codes 21812 and 21813 would likely not occur. By valuing these codes as 0-day globals, we do not need to address these issues because the surgeon will be able to bill separately for the postoperative services that are furnished after the day of the procedure.

    To value these services as 0-day global codes, we subtracted the work RVUs related to the postoperative services from the total work RVU. We are establishing CY 2015 interim work RVUs of 10.79 for CPT code 21811, of 13.00 for CPT code 21812, and of 17.61 for CPT code 21813. We also refined the RUC recommended time by subtracting the time associated with the postoperative visits. By removing the work and time associated with visits in the postoperative period, the remaining work and time reflect the work and time of services furnished on the day of surgery.

    (2) Percutaneous Vertebroplasty and Augmentation (CPT Codes 22510, 22511, 22512, 22513, 22514 and 22515)

    For CY 2015, the CPT Editorial Panel replaced the eight existing percutaneous vertebroplasty with six new codes, CPT codes 22510-22515, which include the percutaneous vertebroplasty and the image guidance together. We are establishing the RUC-recommended work values as interim final for CY 2015 for all of the codes in this family except CPT code 22511.

    Unlike other codes in this family for which the RUC-recommended work RVU was based on the 25th percentile in the survey, the RUC established its recommended work value for CPT code 22511 by crosswalking this service to CPT code 39400 (Mediastinoscopy, includes biopsy(ies), when performed), which has a work RVU of 8.05. Because the level of work performed by a physician in the two services differs, we do not agree that this crosswalk is appropriate. Instead, we believe a more appropriate analogy is found in the difference between the work values for the predecessor codes for CPT codes 22510 and 22511, CPT codes 22520 (Percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body, unilateral or bilateral injection; thoracic) and 22521 (Percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body, unilateral or bilateral injection; thoracic; lumbar). Accordingly, we are applying the difference in the current work RVUs for CPT codes 22520 and 22521 to the work RVU that we are establishing for CPT code 22510. We believe this increment establishes the appropriate rank order in this family and thus are assigning an interim final work RVU of 7.58 for CPT code 22511, which is 0.57 work RVUs lower than the CY 2015 work RVU for CPT code 22510.

    (3) Endobronchial Ultrasound (EBUS) (CPT Code 31620)

    For CY 2015, the RUC reviewed CPT code 31620 because it was identified through the High Volume Growth Services, which are those services for which Medicare utilization increased by at least 100 percent from 2006 to 2011. CPT code 31620 is an add-on code to CPT code 31629 (Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with transbronchial needle aspiration biopsy(s), trachea, main stem and/or lobar bronchus(i)).

    Medicare data show that 82 percent of the time when EBUS is billed it is billed with CPT code 31629. Given this relationship, we believe that CPT code 31620 should be bundled with CPT code 31629. The specialty societies maintain that EBUS is distinct from bronchoscopy with biopsy because the intraservice work of EBUS occurs between the two components of the base code, bronchoscopy and biopsy. However, based upon the discussion at the RUC meeting, we believe that the biopsy actually occurs during the EBUS and the biopsy is actually performed through the EBUS scope. Thus, we do not believe the EBUS code descriptor accurately describes the service nor is it possible to accurately value this service when the descriptor is inaccurate. Therefore, for CY 2015 we are maintaining the CY 2014 work RVU for

    Page 67664

    CPT code 31620. We understand that the RUC will review this code for CY 2016.

    (4) Extracorporeal Membrane Oxygenation (ECMO)/Extracorporeal Life Support (ECLS) (CPT Codes 33946, 33947, 33948, 33949, 33951-33959, 33962-33966, 33969, 33984-33989)

    In the CY 2014 PFS final rule with comment period, CPT codes 33960 (Prolonged extracorporeal circulation for cardiopulmonary insufficiency; initial day) and 33961 (Prolonged extracorporeal circulation for cardiopulmonary insufficiency; each subsequent day) were identified as potentially misvalued codes. Specifically, the services were originally valued when they were primarily provided to premature neonates; but the services are now typically used in treating adults with severe influenza, pneumonia, and respiratory distress syndrome. For CY 2015, CPT codes 33960 and 33961 were deleted and replaced with 25 new codes to describe this treatment. We are assigning the RUC-recommended work values as interim final for CY 2015 for all of the codes in this family except CPT codes 33952, 33953, 33954, 33957, 33958 and 33959, 33962, 33969, and 33984.

    We accepted the RUC-recommended work RVU of 8.15 for CPT code 33951, which describes an ECMO peripheral cannula(e) insertion for individuals up to 5 years of age. The RUC recommended a work RVU of 8.43 for CPT code 33952, which describes the same procedure for individuals 6 years and older. We do not believe this difference in the age of the patient increases the work of the service from the younger patient. The fact that the RUC-recommended intraservice time is identical for both codes supports our view that the work RVU should be the same for both codes. Therefore, for CY 2015, we are establishing an interim final work RVUs of 8.15 for CPT code 33952, the same as we established for CPT 33951 based upon the RUC-recommendation for the younger patient.

    The RUC recommended work RVUs of 9.83 and 9.43 for CPT codes 33953 and 33954, respectively. For the same reasons discussed above, we are establishing the same work values for the code for treatment of patients from birth through 5 years of age and the code for treatment of patients 6 years and older. To determine the value for these codes, we adjusted the work RVU of the equivalent percutaneous codes, CPT code 33951 (Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by physician; insertion of peripheral (arterial and/or venous) cannula(e), percutaneous, birth through 5 years of age (includes fluoroscopic guidance, when performed)) and CPT code 33952 (Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by physician; insertion of peripheral (arterial and/or venous) cannula(e), percutaneous, 6 years and older (includes fluoroscopic guidance, when performed)), to reflect the greater work of the open procedure codes, CPT codes 33953 (Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by physician; insertion of peripheral (arterial and/or venous) cannula(e), open birth, through 5 years of age) and 33954 (Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by physician; insertion of peripheral (arterial and/or venous) cannula(e), open, 6 years and older). To measure the difference in work between these two sets of codes we applied the 0.96 RVU differential between the percutaneous arterial CPT code 33620 (Application of right and left pulmonary artery bands (for example, hybrid approach stage 1)) and the open arterial CPT code 36625 (Arterial catheterization or cannulation for sampling, monitoring or transfusion (separate procedure); cutdown) codes. This measure allows us to establish the difference in work between the sets of codes based upon the difference in intensity. Accordingly, we are assigning an interim final work RVU to CPT codes 33953 and 33954 of 9.11.

    Unlike other codes in this family for which the RUC-recommended work value was based upon the 25th percentile of the survey, for CPT codes 33957 and 33958 the RUC recommended a work RVU of 4.00 and 4.05, respectively, based upon the survey median. We believe that, like other services in this family, these codes should be valued based upon the 25th percentile values of the survey because those values best describe the work involved in these procedures and results in the appropriate relativity amongst the codes in the family. Therefore, for CY 2015 we are assigning an interim final work RVU of 3.51 for CPT codes 33957 and 33958.

    We believe the RUC-recommended work RVUs of 4.69 and 4.73 for CPT codes 33959 and 33962 respectively, overstate the work involved in the services. As we discussed above for CPT codes 33953 and 33954, we believe the differential between the percutaneous arterial and open arterial CPT codes more appropriately reflects the work involved in these services. Accordingly we are establishing a CY 2015 interim final work RVU of 4.47 for CPT codes 33959 and 33962.

    After researching comparable codes, we believe the RUC-recommended work RVUs of 6.00 and 6.38 for CPT codes 33969 and 33984, respectively, overstates the work involved in the procedures. For the same reasons and following the same valuation methodology utilized above, we added the differential between the percutaneous arterial and arterial cutdown codes, 0.96 RVU, to the CY 2015 interim final work RVU of 4.50 for CPT code 33966, which is the percutaneous counterpart of CPT code 33984. This results in a work RVU of 5.46 for CPT code 33984. Because CPT code 33969 has 2 minutes less intraservice time than CPT code 33984 (Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by physician; removal of peripheral (arterial and/or venous) cannula(e), open, 6 years and older), we adjusted the work RVU of CPT code 33984 for the decrease in time to get a work RVU of 5.22 for CPT code 33969 (Extracorporeal membrane oxygenation (ECMO)/

    extracorporeal life support (ECLS) provided by physician; removal of peripheral (arterial and/or venous) cannula(e), open, birth through 5 years of age). Therefore, for CY 2015 we are establishing an interim final work RVU of 5.46 to CPT code 33984 and 5.22 to CPT code 33969.

    (5) Fenestrated Endovascular Repair (FEVAR) Endograft Planning (CPT Code 34839)

    For CY 2015, CPT code 34839 was created to report the planning that occurs prior to the work included in the global period for a FEVAR. The RUC recommended that we contractor price this service as the RUC survey response rate was too low to provide the basis for an appropriate valuation. In general, we prefer that planning be bundled with the underlying service, and we have no reason to believe bundling is not appropriate in this case. Accordingly, we are assigning a PFS procedure status indicator of B (Bundled Code) to CPT code 34839.

    (6) AV Anastomosis (CPT Codes 36818, 36819, 36820, 36821, 36825, 36830, 36831, 36832, and 36833)

    In the CY 2013 PFS final rule with comment period, the AV anastomosis family of services were determined to be potentially misvalued due to rank order anomalies, including CPT codes 36818-36821 and CPT codes 36825-36830. The RUC recommendations that we received

    Page 67665

    in response also included CPT codes 36831-36833. We are assigning the RUC-recommended work RVUs as CY 2015 interim final values for CPT codes 36821, 36831, 36832 and 36833. For CPT code 36831, 36832, and 36833, we are refining to remove the additional 10 minutes of preservice evaluation time. The RUC added 10 minutes of additional pre-service time to these codes for determining the best source of access. These three codes are revision/repair codes and as such do not need the additional time to determine the access source. For CPT code 36818, the RUC recommended an approximately 12 percent increase in work RVU but a total time increase of approximately 4.2 percent. We are assigning a CY 2015 interim final work RVU of 12.39, which reflects a 4.2 percent increase from the current value based upon the increase in total time.

    For CPT code 36819, the RUC-recommended intraservice and total times are only minimally different than the current times. Even though the intraservice and total times decreased minimally, the RUC increased the work RVU. We believe that the small decrease in total time, 2 percent, suggest that the current work RUV is appropriate. Therefore, we are assigning a CY 2015 interim final work RVU of 13.29, which is the current work value.

    The RUC recommended a work value of 13.99 for CPT code 36820. The RUC recommended that the postservice time of CPT code 36820 be reduced by removing visits. Specifically, a CPT code 99231 and one-half of a CPT code 99238 were removed from the service, which would equal 1.40 RVU. We do not believe that this reduction was accounted for in the RUC-recommended work RVU. To account for this reduction in visits, we are establishing a CY 2015 interim final work RVU of 13.07 for CPT 36820 which reflects a 1.40 work RVU reduction in the current work RVU.

    For CPT code 36825, the RUC-recommended intraservice and total times are only minimally different than the current times. However, the RUC increased the work RVU. We do not believe the work RVU should be increased without corresponding time changes. Therefore, we believe the appropriate CY 2015 interim final work RVU is the current work value of 14.17. For CPT code 36830, the RUC-recommended intraservice and total times are only minimally different than the current times. However, the RUC decreased the work RVU. We do not believe the work RVU should be decreased without corresponding time changes. Therefore, we are establishing a CY 2015 interim final work RVU of 12.03, which is equal to the current work RVU.

    Furthermore, we refined the total time values as follows: 238 minutes for CPT code 36831, 266 minutes for CPT code 36832, and 296 minutes for CPT code 36833.

    (7) Illeoscopy, Pouchoscopy, Colonoscopy through Stoma, Flexible Sigmoidoscopy and Colonoscopy (CPT Codes 44380, 44381, 44382, 44383, 44384, 44385, 44386, 44388, 44389, 44390, 44391, 44392, 44393, 44394, 44397, 44401, 44402, 44403, 44404, 44405, 44406, 44407, 44408, 44799, 45330, 45331, 45332, 45333, 45334, 45335, 45337, 45338, 45346, 45340, 45341, 45342, 45345, 45347, 45349, 45350, 45378, 45379, 45380, 45381, 45382, 45383, 45388, 45384, 45385, 45386, 45387, 45389, 45390, 45391, 45392, 45393, 45398, 45399, 0226T, 46601, 0227T, and 46607 and HCPCS Codes G6018, G6019, G6020, G6021, G6022, G6023, G6024, G6025, G6027, G6028)

    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 the current practice. The RUC subsequently provided recommendations to CMS for valuing these services. In comments on the proposed rule, stakeholders noted our proposal to begin including proposed values for new, revised and potentially misvalued codes in the proposed rule. Commenters suggested that, rather than implementing this new process in CY 2016, we should implement it immediately and thus defer the valuation of the new GI code set until CY 2016. They indicated that the opportunity to comment prior to implementation of the new values was important for these codes, many of which have high utilization. In addition, in this final rule with comment period we discuss the need to modify how moderate sedation is reported and valued. Since the valuation of most codes in this code set includes moderate sedation, stakeholders suggested that we revalue these codes in conjunction with any changes in reporting and valuation of moderate sedation.

    We agree with the commenters. In light of the substantial nature of this code revision and its relationship to the policies on moderate sedation, we are delaying revaluation of these codes until CY 2016 when we will be able to include proposals in the proposed rule for their valuation, along with consideration of policies for moderate sedation. Accordingly for CY 2015, we are maintaining the inputs for the lower gastrointestinal endoscopy codes at the CY 2014 levels. (Note: Due to budget neutrality adjustments and other system-wide changes, the payment rates may change.) Since the code set is changing for CY 2015, including the deletion of some of the CY 2014 codes, we are creating G-

    codes as necessary to allow practitioners to report services to CMS in the same way in CY 2015 that they did in CY 2014 and to maintain payment under the PFS based on the same inputs. All payment policies applicable to the CY 2014 CPT codes will apply to the replacement G-

    codes. The new and revised CY 2015 CPT codes for lower gastrointestinal endoscopy that will not be recognized by Medicare for CY 2015 are denoted with an ``I'' (Not valid for Medicare purposes) in Table 26. The chart below lists the G-codes that we are creating and the CY 2014 CPT codes that they are replacing.

    Table 26--Lower Gastrointestinal Endoscopy G-Codes Replacing CY 2015 CPT Codes

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

    CY 2014 CPT code \1\ CY 2015 HCPCS code Long descriptor

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

    44383................... G6018................... Ileoscopy, through stoma; with transendoscopic stent

    placement (includes predilation).

    44393................... G6019................... Colonoscopy through stoma; with ablation of tumor(s),

    polp(s), or other lesion(s) not amenable to removal by hot

    biopsy forceps, bipolar cautery or snare technique.

    44397................... G6020................... Colonoscopy through stoma; with transendoscopic stent

    placement (includes predilation).

    44799................... G6021................... Unlisted procedure, intestine.

    45339................... G6022................... Sigmoidoscopy, flexible; with ablation of tumor(s),

    polyp(s), or other lesions(s)not amenable to removal by hot

    biopsy forceps, bipolar cautery or snare technique.

    Page 67666

    45345................... G6023................... Sigmoidoscopy, flexible; with transenoscopic stent placement

    (includes predilation).

    45383................... G6024................... Colonoscopy, flexible, proximal to splenic flexure; with

    ablation of tumor(s), polyp(s), or other lesion(s) not

    amenable to removal by hot biopsy forceps, bipolar cautery

    or snare technique.

    45387................... G6025................... Colonoscopy, flexible, proximal to splenic flexure; with

    transendoscopic stent placement (includes predilation).

    0226T................... G6027................... Anoscopy, high resolution (HRA) (with magnification and

    chemical agent enhancement); diagnostic, including

    collection of specimen(s) by brushing or washing when

    performed.

    0227T................... G6028................... Anoscopy, high resolution (HRA) (with magnification and

    chemical agent enhancement); with biopsy(ies).

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

    \1\ This chart only contains CY 2014 codes for which a HCPCS code is being used for CY 2015. Addendum B contains

    a complete list of CPT and HCPCS codes being recognized by Medicare under the PFS for CY 20115.

    (8) Prostatectomy (CPT Codes 55842 and 55845)

    In the CY 2014 PFS final rule with comment period, we finalized CPT codes 55842 and 55845 as potentially misvalued codes. For CY 2015, the RUC provided recommendations for these services of 29.07 and 24.16, respectively. We disagreed with the RUC-recommended crosswalk for CPT code 55842. To value CPT code 55842, we are crosswalking it to CPT code 55840 (Prostatectomy, retropubic radical, with or without nerve sparing) due to their identical times. Therefore, we are establishing an interim final work RVU of 21.36.

    For CPT code 55845, we are establishing a work RVU of 25.18 based upon the 25th percentile of the survey. This work RVU results in an 18 percent decrease from the current work RVU, which we believe reflects the changes since the last valuation, based upon a 20 percent decrease in intraservice time and the 29 percent decrease in total time.

    (9) Aqueous Shunt (CPT Code 66179, 66180, 66184, 66185, and 67255)

    After identifying CPT code 66180 through the Harvard-Valued Annual Allowed Charges Greater than $10 million screen, the RUC recommended work RVUs for the aqueous shunt family for CY 2015. We are establishing the RUC-recommended work RVUs as interim final for all codes in this family except CPT code 67255. The RUC recommended maintaining the CY 2014 work RVU of 10.17 for CPT 67255. However, we believe maintaining this value would be inconsistent with the RUC-recommended decreases in total time for the service. As a result, we reduced the work RVU by the same percentage that the RUC recommended a reduction in total time, which results in a CY 2015 interim final work RVU of 8.38 for CPT code 67255.

    (10) Computed Tomography (CT)--Maxillofacial (CPT Codes 70486, 70487 and 70488)

    The RUC's Relativity Assessment Workgroup identified CPT code 70486 for review through the CMS/Other Source--Utilization over 250,000 screen. The involved specialty societies expanded the survey to include CPT codes 70487 and 70488, all of which involve maxillofacial CTs. We are establishing the RUC-recommended work RVU of 0.85 as the CY 2015 interim final value for CPT code 70486, which is without contrast material. The RUC established this recommendation by crosswalking this code to the equivalent code in the CT for the head or brain, CPT code 70450 (Computed tomography, head or brain without contrast). We agree with that method and in order to maintain rank order within and across CT families, we crosswalked CPT code 70487, which is with contrast material(s), to the CPT code 70460, which is the equivalent code in the head or brain family and CPT code 70488, which is without contrast materials followed by contrast material(s) and further sections to CPT code 70470, which is the equivalent code in the head or brain family. Therefore, for CY 2015 we are establishing interim final work RVUs of 1.13 for CPT code 70487 and 1.27 for CPT code 70488.

    (11) Breast Ultrasound (CPT Codes 76641 and 76642)

    For CY 2015, the CPT Editorial Panel replaced CPT code 76645 (Ultrasound, breast(s) (unilateral or bilateral), real time with image documentation) with two codes, CPT codes 76641 (Ultrasound, breast, unilateral, real time with image documentation, including axilla when performed; complete) and 76642 (Ultrasound, breast, unilateral, real time with image documentation, including axilla when performed; limited). The difference between the new codes is that one is for complete breast ultrasound procedures and the other is for limited. We are assigning the RUC-recommended work RVUs of 0.73 and 0.68 to CPT codes 76641 and 76642, respectively, as interim final. One difference between the predecessor code and the new ones is that while the predecessor code was used to report unilateral or bilateral breast ultrasounds, the new codes are unilateral ones. To appropriately adjust payment when bilateral procedures are furnished under the PFS, payments are adjusted to 150 percent of the unilateral payment when a service has a bilateral payment indicator assigned. We are assigning a bilateral payment indicator to these codes.

    (12) Radiation Therapy Codes (CPT Codes 76950, 77014, 77421, 77387, 77401, 77402, 77403, 77404, 77406, 77407, 77408, 77409, 77411, 77412, 77413, 77414, 77416, 77418, 77385, 77386, 0073T, and 0197T and HCPCS Codes G6001, G6002, G6003, G6004, G6005, G6006, G6007, G6008, G6009, G6010, G6011, G6012, G6013, G6014, G6015, G6016 and G6017)

    CPT revised the radiation therapy code set for CY 2015 following identification of some of the codes as potentially misvalued and the affected specialty society's contention that the provision of radiation therapy could not be accurately reported under the existing code set. The RUC subsequently provided recommendations to CMS for valuing these services. Some stakeholders approached CMS with concerns about these codes being revalued as interim final in the final rule with comment period, noting that these codes account for the vast majority of Medicare payment for radiation therapy centers. They noted our proposal to begin including proposals to value new, revised and potentially misvalued codes in the proposed rule, and suggested that these code valuations should be delayed to CY 2016 so that they could be addressed under this new process. This would provide affected

    Page 67667

    stakeholders the opportunity to comment prior to the valuations being effective. They also noted that since they do not participate in the RUC, they did not have the opportunity to provide input to the recommendations nor will they have information about the RUC recommendations until CMS makes this information available in the final rule with comment period.

    In response to comments and in light of the substantial nature of this code revision, we are delaying revaluation of these codes until CY 2016. The coding changes for CY 2015 involve significant changes in how radiation therapy services and associated image guidance are reported. There is substantial work to be done to assure the new valuations for these codes accurately reflect the coding changes. Accordingly we are delaying the use of the revised radiation therapy code set until CY 2016 when we will be able to include proposals in the proposed rule for their valuation. We are maintaining the inputs for radiation therapy codes at the CY 2014 levels. (Note: Due to budget neutrality adjustments and other system-wide changes, the payment rates may change.) Since the code set has changed and some of the CY 2014 codes are being deleted, we are creating G-codes as necessary to allow practitioners to continue to report services to CMS in CY 2015 as they did in CY 2014 and for payments to be made in the same way. All payment policies applicable to the CY 2014 CPT codes will apply to the replacement G-codes. The new and revised CY 2015 CPT codes that will not be recognized by Medicare for CY 2015 are denoted with an ``I'' (Not valid for Medicare purposes) on Table 27. The chart below lists the G-codes that we are creating and the CY 2014 CPT codes that they are replacing.

    Additionally, we would like to note that changes to the prefatory text modify the services that are appropriately billed with CPT code 77401, which is used to report superficial radiation therapy. This change effectively means that CPT code 77401 is now bundled with many other procedures supporting superficial radiation therapy. However, the RUC did not review superficial radiation therapy procedures, and therefore, did not assess whether changes in its valuation were appropriate in light of this bundling. Stakeholders have suggested to us that the change to the prefatory text prohibits them from billing for codes that were previously frequently billed in addition to this code and as a result there will be a significant reduction in their payments.'' We are interested in information on whether the new code set combined with modifications in prefatory text allows for appropriate reporting of the services associated with superficial radiation and whether the payment continues to reflect the relative resources required to furnish superficial radiation therapy services.

    Table 27--Radiation Therapy G-Codes Replacing CY 2015 CPT Codes

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

    CY 2014 CPT code \2\ CY 2015 HCPCS code Long descriptor

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

    76950................... G6001................... Ultrasonic guidance for placement of radiation therapy

    fields.

    77421................... G6002................... Stereoscopic X-ray guidance for localization of target

    volume for the delivery of radiation therapy.

    77402................... G6003................... Radiation treatment delivery, single treatment area, single

    port or parallel opposed ports, simple blocks or no blocks:

    up to 5MeV.

    77403................... G6004................... Radiation treatment delivery, single treatment area, single

    port or parallel opposed ports, simple blocks or no blocks:

    6-10MeV.

    77404................... G6005................... Radiation treatment delivery, single treatment area, single

    port or parallel opposed ports, simple blocks or no blocks:

    11-19MeV.

    77406................... G6006................... Radiation treatment delivery, single treatment area, single

    port or parallel opposed ports, simple blocks or no blocks:

    20 MeV or greater.

    77407................... G6007................... Radiation treatment delivery, 2 separate treatment areas, 3

    or more ports on a single treatment area, use of multiple

    blocks; up to 5MeV.

    77408................... G6008................... Radiation treatment delivery, 2 separate treatment areas, 3

    or more ports on a single treatment area, use of multiple

    blocks; 6-10MeV.

    77409................... G6009................... Radiation treatment delivery, 2 separate treatment areas, 3

    or more ports on a single treatment area, use of multiple

    blocks; 11-19MeV.

    77411................... G6010................... Radiation treatment delivery, 2 separate treatment areas, 3

    or more ports on a single treatment area, use of multiple

    blocks; 20 MeV or greater.

    77412................... G6011................... Radiation treatment delivery, 3 or more separate treatment

    areas, custom blocking, tangential ports, wedges,

    rotational beam, compensators, electron beam; up to 5MeV.

    77413................... G6012................... Radiation treatment delivery, 3 or more separate treatment

    areas, custom blocking, tangential ports, wedges,

    rotational beam, compensators, electron beam; 6-10MeV.

    77414................... G6013................... Radiation treatment delivery, 3 or more separate treatment

    areas, custom blocking, tangential ports, wedges,

    rotational beam, compensators, electron beam; 11-19MeV.

    77416................... G6014................... Radiation treatment delivery, 3 or more separate treatment

    areas, custom blocking, tangential ports, wedges,

    rotational beam, compensators, electron beam; 20MeV or

    greater.

    77418................... G6015................... Intensity modulated treatment delivery, single or multiple

    fields/arcs, via narrow spatially and temporally modulated

    beams, binary, dynamic MLC, per treatment session.

    0073T................... G6016................... Compensator-based beam modulation treatment delivery of

    inverse planned treatment using 3 or more high resolution

    (milled or cast) compensator, convergent beam modulated

    fields, per treatment session.

    0197T................... G6017................... Intra-fraction localization and tracking of target or

    patient motion during delivery of radiation therapy (eg, 3D

    positional tracking, gating, 3D surface tracking), each

    fraction of treatment.

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

    Page 67668

    (13) Breast Tomosynthesis (CPT codes 77061, 77062, and 77063)

    For CY 2015, the CPT Editorial Panel created three codes to describe digital breast tomosynthesis services: 77061 (Digital breast tomosynthesis; unilateral), 77062 (Digital breast tomosynthesis; bilateral) and 77063 (Screening digital breast tomosynthesis, bilateral (List separately in addition to code for primary procedure) and we received RUC recommendations for these codes. Currently, these services are reported to Medicare using G0202, G0204, and G0206, which describe the equivalent procedures using any digital technology (2-D or 3-D). In addition, film mammography is reported to Medicare using CPT codes 77055, 77056 and 77057).

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

    \2\ This chart only contains CY 2014 codes for which a HCPCS code is being used for CY 2015. Addendum B contains a complete list of CPT and HCPCS codes being recognized by Medicare under the PFS for CY 2015.

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

    In the proposed rule, based upon our belief that digital mammography is now typical, we proposed to replace the G-codes that currently describe all digital mammography services under Medicare with the CPT codes, to value the CPT codes for CY 2015 based upon the current G-code values, and to include the CPT codes on the potentially misvalued code list since the resources involved in furnishing these services had not been evaluated in more than a decade. Having reassessed the proposal in light of the new codes and RUC recommendations for tomosynthesis and the comments received upon our proposal, we are finalizing a modified proposal. For a discussion of our proposal, a summary of the comments we received, and our policy for CY 2015, see section II.B.4.

    With regard to screening mammography, the CPT coding system now has an add-on CPT code for tomosynthesis. This coding scheme is consistent with the FDA requiring a 2-D mammography when tomosynthesis is used for screening purposes. Accordingly, we will recognize CPT code 77063 to be reported, when tomosynthesis is used in addition to 2-D mammography. Since CPT code 77063 is an add-on code, and does not have an equivalent CY 2014 code, we believe it is appropriate to value it on an interim final basis in advance of receiving the RUC recommendations for other mammography services. We are assigning it a CY 2015 interim final work RVU of 0.60 as recommended by the RUC.

    Whenever feasible, it is our strong preference to value entire families together in order to avoid rank order anomalies. In this final rule with comment period, we are including the codes for digital mammography on the potentially misvalued code list, which currently includes tomosynthesis as well as 2-D mammography. Accordingly, we will wait to value the new diagnostic mammography tomosynthesis codes until we have received recommendations from the RUC for all mammography services. In the interim, we are assigning a PFS indicator of ``I'' to 77061 and 77062. Those furnishing diagnostic mammography using tomosynthesis will continue to report G0204 and G0206 as appropriate. In addition, we are creating a new code, G-2079 (Diagnostic digital breast tomosynthesis, unilateral or bilateral (List separately in addition to G0204 or G0206)) as an add-on code that should be reported in addition to the relevant 2-D diagnostic mammography G-code to recognize the additional resources involved in furnishing diagnostic breast tomosynthesis. We will assign it the same inputs as CPT code 77063 because we believe it describes a similar service.

    (14) Isodose Calculation with Isodose Planning Bundle (CPT Code 77316)

    For CY 2015, the CPT Editorial Panel replaced six CPT codes (77305, 77310, 77315, 77326, 77327, and 77328) with five new CPT codes to bundle basic dosimetry calculation(s) with teletherapy and brachytherapy isodose planning. We are establishing the RUC-recommended work RVUs for CY 2015 for all of the codes in this family except CPT code 77316. We disagree with the RUC-recommended crosswalk for this service because we do not believe it is an appropriate match in work. The RUC crosswalked CPT code 77318 to CPT code 77307, both of which are complex isodose planning codes in the same family. We believe that the RUC should have crosswalked CPT code 77316, a simple isodose planning code, to the corresponding simple isodose planning code in the same family, CPT code 77306. Therefore, for CY 2015 we are establishing an interim final work RVU of 1.40 for CPT code 77316.

    (15) Immunohistochemistry (CPT codes 88341, 88342, and 88344; HCPCS codes G0461 and G0462)

    In the CY 2014 PFS final rule with comment period (78 FR 74341), we assigned a status indicator of I (Not valid for Medicare purposes) to CPT codes 88341, 88342, and 88343 and instead created two G-codes, G0461 and G0462, to report immunohistochemistry services. We did this in part to avoid creating incentives for overutilization. For CY 2015, the CPT coding was revised with the creation of two new CPT codes, 88341 and 88344, the revision of CPT code 88342 and the deletion of CPT code 88343. We believe that the revised coding structure addresses the concerns that we had with the CY 2014 coding regarding the creation of incentives and overutilization. Accordingly, we are deleting the G-

    codes and assigning interim final values for these CPT codes for CY 2015. We are establishing the RUC-recommended work RVUs as interim final for CY 2015 for CPT codes 88342 and 88344.

    In the past for similar procedures in this family, the RUC recommended a work RVU for the add-on code that was 60 percent of the base code. For example, the RUC-recommended work RVU for CPT code 88334 (Pathology consultation during surgery; cytologic examination (for example, touch prep, squash prep), each additional site (List separately in addition to code for primary procedure)) is 60 percent of the work RVU of the base CPT code 88333 (Pathology consultation during surgery; cytologic examination (for example, touch prep, squash prep), initial site). Similarly, the RUC-recommended work RVU for CPT code 88177 (Cytopathology, evaluation of fine needle aspirate; immediate cytohistologic study to determine adequacy for diagnosis, each separate additional evaluation episode, same site (List separately in addition to code for primary procedure)) is 60 percent of the recommended value for the base CPT code 88172 (Cytopathology, evaluation of fine needle aspirate; immediate cytohistologic study to determine adequacy for diagnosis, first evaluation episode, each site). We believe that the relative resources involved in furnishing an add-on service in this family would be reflected appropriately using the same 60 percent metric. To value CPT code 88341, we calculated 60 percent of the work RVU of the base CPT code 88342, which has a work RVU of 0.70; resulting in a work RVU of 0.42 for CPT code 88341.

    (16) Morphometric Analysis In Situ Hybridization for Gene Rearrangement(s) (CPT Codes 88364, 88365, 88366, 88368, 88369, 88373, and 88374 and 88377)

    For CY 2014, the in situ hybridization procedures, CPT codes 88365, 88367 and 88368, were revised to specify ``each separately identifiable probe per block;'' three new add-on codes (CPT codes 88364, 88373, 88369) were created to specify ``each additional

    Page 67669

    separately identifiable probe per slide;'' and three new codes were created to specify ``each multiplex probe stain procedure.'' We are establishing the RUC-recommended work RVUs as interim final for CY 2015 for CPT codes 88365, 88366, 88368, and 88377.

    CPT code 88367 is the computer assisted version of morphometric analysis, analogous to 88368 which is the manual version. We have accepted the RUC recommended work RVU of 0.88 for 88368 which has 30 minutes of intraservice time. CPT code 88367 only has 25 minutes of intraservice time and we do not believe that the RUC recommended work RVU of 0.86 adequately reflects that change in time. We believe that the ratio of the intraservice times (25/30) applied to the work RVU (0.88) adequately reflects the difference in work. Therefore, we are assigning an interim final work RVU to CPT code 88367 of 0.73.

    Similarly, CPT code 88374 is the computer assisted version of CPT code 88377 but with a drop in intraservice time from 45 minutes to 30 minutes. We believe applying this ratio to the work RUV of 88377 more accurately reflects the work. Therefore, we are assigning an interim final work RVU to CPT code 88374 of 0.93.

    As discussed in the previous section, some of the add-on codes in this family had RUC-recommended work RVUs that were 60 percent of the work RVU of the base procedure and we applied that reduction to 88341. We believe this accurately reflects the resources used in furnishing these add-on codes. Accordingly, we used this methodology to establish interim final work RVUs of 0.53 for code 88364 (60 percent of the work RVU of CPT code 88365); 0.53 for CPT code 88369 (60 percent of the work RVU of CPT code 88368); and 0.43 for CPT code 88373 (60 percent of the work RVU of CPT code 88367).

    (17) Electro-oculography (EOG VNG) CPT Codes 92270, 92540, 92541, 92542, 92544, 92543, and 92545)

    After the RUC identified CPT code 92543 as potentially misvalued through the CMS-Other Source--Utilization over 250,000 screen, CPT revised the parentheticals for this code for CY 2015. We received RUC recommendations for CY 2015 for this code and other codes in the family. We are assigning the RUC-recommended work values for CPT codes 92270, 92540, 92541, 92542, 92544, and 92545. For CPT code 92543, however, we have been informed by the RUC that survey respondents may not have understood the revised code description for CPT code 92543, and thus the survey data may be unreliable. As a result, we believe the most accurate information upon which to base work RVUs for CPT code 92543 is its existing work RVU. Therefore, we are establishing a work RVU of 0.10 for CPT code 92543 as interim final for CY 2015.

    (18) Interventional Transesophageal Echocardiography (TEE) (CPT Codes 93312, 93313, 93314, 93315, 93316, 93317, 93318, 93355, and 93644)

    For CY 2015, CPT code 93355 was created to describe transesophageal echocardiography during interventional cardiac procedures. The RUC provided recommendations for CPT code 93355, and for CPT codes 93312-

    93318 in order to ensure intra-family relativity. We are establishing the RUC-recommended work RVU of 2.40 as interim final for CY 2015 for CPT code 93318 and 4.66 for CPT code 93355.

    The RUC based the work RVU for CPT code 93312 upon a crosswalk to CPT code 43247 (Esophagogastroduodenoscopy, flexible, transoral; with removal of foreign body). This code has significant differences from CPT code 93312. We have been unable to identify a CPT code with 30 minutes of intraservice time and 60 minutes of total time with a work RVU higher than 2.55. We believe this service is more similar to CPT code 75573 (Computed tomography, heart, with contrast material, for evaluation of cardiac structure and morphology in the setting of congenital heart disease (including 3D image postprocessing, assessment of LV cardiac function, RV structure and function and evaluation of venous structures, if performed) since it has similar work, time and the same global period. Based upon this crosswalk, we are assigning CPT code 93312 a CY 2015 interim final work RVU of 2.55.

    Due to CPT descriptor for CPT code 93315, we believe that the appropriate work for this service is reflected in the combined work of CPT codes 93316 and 93317, resulting in a CY 2015 interim final work RVU of 2.94.

    For CPT codes 93313, 93314, 93316 and 93317, we are assigning CY 2015 interim final work RVUs based upon the 25th percentile values from the survey: 0.51 for CPT code 93313, 2.10 for CPT code 93314, 2.94 for CPT code 93315, 0.85 for CPT code 93316, 2.09 for CPT code 93317, and 4.66 for CPT code 93355. Each of these codes had a significant drop in intraservice time since the last valuation and RUC recommendations for higher work RVUs. As we have stated in the absence of information showing a change in intensity, we believe meaningful changes in time should be reflected in the work RVUs. For these codes, we believe the 25th percentile survey values better describe the work and time involved in these procedures than the RUC recommendations and also help maintain appropriate relativity in the family. Additionally, we are refining the preservice and intraservice times for CPT codes 93314 and 93317 to 10 and 20 minutes, respectively, to maintain relativity among the interim final work RVUs and times.

    (19) Subcutaneous Implantable Defibrillator Procedures (CPT Codes 33270, 33271, 33272, 33272, 93260, 93261 and 93644)

    For CY 2015, the CPT Editorial Panel added the word ``implantable'' to the descriptors for several codes in this family and created several new codes, CPT codes 33270, 33271, 33272, 33272, 93260, 93261 and 93644. We received RUC recommendations for the new and revised codes. We are establishing the RUC-recommended work RVUs for all of the codes in this family except CPT code 93644. This code has an intraservice time of 20 minutes and a total time of 84 minutes. We disagree with the RUC-recommended crosswalk for CPT code 93644 which has an intraservice time of 29 minutes and a total time of 115 minutes and believe that a crosswalk to CPT code 32551 would be better as that code's intraservice time is 20 minutes and the total time is 83 minutes. Therefore, we are establishing a CY 2015 interim final work RVU of 3.29 for CPT code 93644.

    (20) Duplex Scans (CPT Codes 93886, 93888, 93926, 93975, 93976, 93977, 93978, and 93979)

    In the CY 2013 PFS final rule with comment period, we requested that the RUC assess the relativity among the entire family of duplex scans codes and recommend appropriate work RVUs. CMS also requested that the RUC consider CPT codes 93886, Transcranial Doppler study of the intracranial arteries; complete study, and 93888, Transcranial Doppler study of the intracranial arteries; limited study, in conjunction with the duplex scan codes in order to assess the relativity between and among those codes. The RUC reviewed this entire family of codes and provided recommendations for CY 2015. For CY 2015, we are establishing the RUC-recommended work RVUs as interim final for all of the codes in the family except CPT codes 93886, 93888, 93926, 93975, 93976, 93977, 93978, and 93979.

    For several codes in this family with 10 minutes of intraservice time, the RUC recommended 0.50 work RVUs. We

    Page 67670

    believe that this relationship between intraservice time and work RVU accurately reflects the time and intensity involved, and should be used for the majority of the codes in the family. As a result, for CPT codes 93926, 93979, and 93888, which all have 10 minutes of intraservice time, we are assigning an interim final work RVU of 0.50.

    For several codes in this family with 15 minutes of intraservice time, the RUC recommended work RVUs based upon the survey 25th percentile. We find this to appropriately reflect the work involved. Accordingly, for CPT codes 93975, 93976, and 93978, which all have 15 minutes of intraservice time, we are disagreeing with the RUC work RVU recommendations and assigning the 25th percentile of the survey as CY 2015 interim final values. Therefore, for CY 2015 we are establishing the following interim final work RVUs: 1.16 for CPT code 93975, 0.80 for CPT code 93976, 0.80 for CPT code 93978 and 0.50 for CPT code 93979. Lastly, we believe that the RUC recommendation for CPT code 93886 overvalues the work involved. We accepted the RUC recommendation for CPT code 93880 of 0.80 with an intraservice time of 15 minutes. CPT code 93886 has an intraservice time of 17 minutes. Applying the work RVU to time ratio of CPT code 93880 to the intraservice time of CPT code 93886 (results in our interim final value of 0.91 for CPT code 93886.

    (21) Carotid Intima-Media Thickness Ultrasound (CPT Code 93895)

    For CY 2015, a new code, CPT code 93895, describes the work of using carotid ultrasound to measure atherosclerosis and quantify the intima-media thickness. After review of this code, we determined that it is used only for screening and therefore, we are assigning a PFS procedure status indicator of N (Noncovered service) to CPT code 93895.

    (22) Doppler Flow Testing (CPT Code 93990)

    For CY 2015, the RUC provided a recommendation for CPT code 93990 which had been identified through the High Volume Growth Services where Medicare utilization increased by at least 100 percent from 2006 to 2011. The RUC recommended a work RVU of 0.60 for this service. Due to the similarity of this service to duplex scans, we are establishing RVUs for CPT code 93990 that are consistent with duplex scans with 10 minutes of intraservice time; which we discussed above in section E.4.18. We assigned it an interim final work RVU of 0.50.

    (23) Electronic analysis of implanted neurostimulator (CPT Codes 95971 and 95972)

    For CY 2015, the RUC reviewed CPT codes 95971 and 95972 because they were identified by the High Volume Growth Services screen which identifies services in which Medicare utilization increased by at least 100 percent from 2006 to 2011 screen. It is unclear to us why CPT code 95973, the add-on code to CPT code 95972, was not also surveyed. We are valuing CPT code 95971 based upon the RUC recommended work RVU of 0.78.

    For CPT code 95972, we do not believe that the RUC recommended change in work RVU from 1.50 to 0.90 reflects the much more significant change in intraservice time from 60 minutes to 23 minutes. Therefore, we used a building block methodology to develop a work RUV of 0.80.

    Even though the RUC did not survey 95973, we believe we should review it as part of this family. Not having a survey or RUC recommendations, we believe that the percent decrease in the work RVU from the base code 95972 should apply to this code. Therefore, we are establishing an interim final work RVU of 0.49 for CPT code 95973.

    We note that the descriptor for CPT code 95972 was changed from ``. . . first hour'' to ``. . .up to one hour.'' We note that for Medicare purposes this code should only be billed when a majority of an hour is completed. We would also note that the add-on code should only be reported after a full 60 minutes of service is furnished.

    The lack of a survey for CPT code 95973 along with the confusing descriptor language and intraservice time suggest the need for this family to be returned to CPT for clarification of the descriptor and then to the RUC for resurvey.

    (24) Negative Pressure Wound Therapy (CPT Codes 97607, and 97608, and HCPCS codes G0456 and G0457)

    Prior to CY 2013, the codes used to report negative pressure wound therapy were CPT codes 97605 and 97606, both of which were typically reported in conjunction with durable medical equipment that was paid separately. In the CY 2013 final rule with comment period, we created two HCPCS codes to provide a payment mechanism for negative pressure wound therapy services furnished to beneficiaries using equipment that is not paid for as durable medical equipment: G0456 (Negative pressure wound therapy, (for example, vacuum assisted drainage collection) using a mechanically-powered device, not durable medical equipment, including provision of cartridge and dressing(s), topical application(s), wound assessment, and instructions for ongoing care, per session; total wound(s) surface area less than or equal to 50 square centimeters) and G0457 (Negative pressure wound therapy, (for example, vacuum assisted drainage collection) using a mechanically-powered device, not durable medical equipment, including provision of cartridge and dressing(s), topical application(s), wound assessment, and instructions for ongoing care, per session; total wound(s) surface area greater than 50 sq cm).

    For CY 2015, two new codes, CPT codes 97607 and 97608, were created to describe negative pressure wound therapy with the use of a disposable system. In addition, CPT codes 97605 and 97606 were revised to specify the use of durable medical equipment. Based upon these the revised coding scheme for negative pressure wound therapy, we are deleting the G-codes. We are contractor pricing these codes for CY 2015. CPT codes 97607 and 97608 will be designated ``Sometimes Therapy'' on our Therapy Code List, which is consistent with the G-

    codes. The Therapy Code List is available at http://www.cms.gov/Medicare/Billing/TherapyServices/index.html?redirect=/therapyservices.''

    (25) Application of Topical Fluoride Varnish (CPT Code 99188)

    CPT Code 99188 is a new code for CY 2015 that describes the application of topical fluoride varnish to teeth. Since this code describes a service that involves the care of teeth, it is excluded from coverage under Medicare by section 1862(a)(12) of the Act, which provides ``items and services in connection with the care, treatment, filling, removal, or replacement of teeth, or structures directly supporting the teeth are excluded from coverage.'' Accordingly, we are assigning a PFS procedure status indicator of N (Noncovered service) to CPT code 99188.

    (26) Advance Care Planning (CPT codes 99497 and 99498)

    For CY 2015, the CPT Editorial Panel created two new codes describing advance care planning 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)

    Page 67671

    and/or surrogate); and an add-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)). For CY 2015, we are assigning a PFS 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. However, we will consider whether to pay for CPT codes 99497 and 99498 after we have had the opportunity to go through notice and comment rulemaking.

  38. Establishing Interim Final Direct PE RVUs for CY 2015

  39. Background and Methodology

    The RUC provides CMS with recommendations regarding direct PE inputs, including clinical labor, disposable supplies, and medical equipment, for new, revised, and potentially misvalued codes. We review the RUC-recommended direct PE inputs on a code-by-code basis, including the recommended facility PE inputs and/or nonfacility PE inputs. This review is informed by both our clinical assessment of the typical resource requirements for furnishing the service and our intention to maintain the principles of accuracy and relativity in the database. We determine whether we agree with the RUC's recommended direct PE inputs for a service or, if we disagree, we refine the PE inputs to represent inputs that better reflect our estimate of the PE resources required to furnish the service in the facility and/or nonfacility settings. We also confirm that CPT codes should have facility and/or nonfacility direct PE inputs and make changes based on our clinical judgment and any PFS payment policies that would apply to the code.

    We have accepted for CY 2015, as interim final and without refinement, the direct PE inputs based on the recommendations submitted by the RUC for the codes listed in Table 28. For the remainder of the RUC's direct PE recommendations, we have accepted the PE recommendations submitted by the RUC as interim final, but with refinements. These codes and the refinements to their direct PE inputs are listed in Table 31.

    We note that the final CY 2015 PFS direct PE input database reflects the refined direct PE inputs that we are adopting on an interim final basis for CY 2015. That database is available under downloads for the CY 2015 PFS final rule with comment period on the CMS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. We also note that the PE RVUs displayed in Addenda B and C reflect the interim final values and policies described in this section. All PE RVUs adopted on an interim final basis for CY 2015 are included in Addendum C and are open for comment in this final rule with comment period.

    Table 28--CY 2015 Interim Final Codes With Direct PE Input

    Recommendations Accepted Without Refinement

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

    HCPCS Short Descriptor

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

    11980............................. Implant hormone pellet(s)

    22512............................. Vertebroplasty addl inject

    22515............................. Perq vertebral augmentation

    22856............................. Cerv artific diskectomy

    27280............................. Fusion of sacroiliac joint

    31620............................. Endobronchial us add-on

    33270............................. Ins/rep subq defibrillator

    33271............................. Insj subq impltbl dfb elctrd

    33272............................. Rmvl of subq defibrillator

    33273............................. Repos prev impltbl subq dfb

    33951............................. Ecmo/ecls insj prph cannula

    33952............................. Ecmo/ecls insj prph cannula

    33953............................. Ecmo/ecls insj prph cannula

    33954............................. Ecmo/ecls insj prph cannula

    33955............................. Ecmo/ecls insj ctr cannula

    33956............................. Ecmo/ecls insj ctr cannula

    33957............................. Ecmo/ecls repos perph cnula

    33958............................. Ecmo/ecls repos perph cnula

    33959............................. Ecmo/ecls repos perph cnula

    33962............................. Ecmo/ecls repos perph cnula

    33963............................. Ecmo/ecls repos perph cnula

    33964............................. Ecmo/ecls repos perph cnula

    33969............................. Ecmo/ecls rmvl perph cannula

    33984............................. Ecmo/ecls rmvl prph cannula

    33985............................. Ecmo/ecls rmvl ctr cannula

    33986............................. Ecmo/ecls rmvl ctr cannula

    33988............................. Insertion of left heart vent

    33989............................. Removal of left heart vent

    36818............................. Av fuse uppr arm cephalic

    36819............................. Av fuse uppr arm basilic

    36820............................. Av fusion/forearm vein

    36821............................. Av fusion direct any site

    36825............................. Artery-vein autograft

    36830............................. Artery-vein nonautograft

    36831............................. Open thrombect av fistula

    36832............................. Av fistula revision open

    36833............................. Av fistula revision

    37218............................. Stent placemt ante carotid

    43180............................. Esophagoscopy rigid trnso

    52441............................. Cystourethro w/implant

    55840............................. Extensive prostate surgery

    55842............................. Extensive prostate surgery

    55845............................. Extensive prostate surgery

    58541............................. Lsh uterus 250 g or less

    58542............................. Lsh w/t/o ut 250 g or less

    58543............................. Lsh uterus above 250 g

    58544............................. Lsh w/t/o uterus above 250 g

    58570............................. Tlh uterus 250 g or less

    58571............................. Tlh w/t/o 250 g or less

    58572............................. Tlh uterus over 250 g

    58573............................. Tlh w/t/o uterus over 250 g

    64486............................. Tap block unil by injection

    64487............................. Tap block uni by infusion

    64488............................. Tap block bi injection

    64489............................. Tap block bi by infusion

    66179............................. Aqueous shunt eye w/o graft

    66180............................. Aqueous shunt eye w/graft

    66184............................. Revision of aqueous shunt

    66185............................. Revise aqueous shunt eye

    67036............................. Removal of inner eye fluid

    67039............................. Laser treatment of retina

    67040............................. Laser treatment of retina

    67041............................. Vit for macular pucker

    67042............................. Vit for macular hole

    67043............................. Vit for membrane dissect

    67255............................. Reinforce/graft eye wall

    70496............................. Ct angiography head

    70498............................. Ct angiography neck

    76770............................. Us exam abdo back wall comp

    76775............................. Us exam abdo back wall lim

    76856............................. Us exam pelvic complete

    76857............................. Us exam pelvic limited

    77080............................. Dxa bone density axial

    77316............................. Brachytx isodose plan simple

    77317............................. Brachytx isodose intermed

    77318............................. Brachytx isodose complex

    88348............................. Electron microscopy

    88356............................. Analysis nerve

    91200............................. Liver elastography

    92145............................. Corneal hysteresis deter

    92541............................. Spontaneous nystagmus test

    92542............................. Positional nystagmus test

    92544............................. Optokinetic nystagmus test

    92545............................. Oscillating tracking test

    93260............................. Prgrmg dev eval impltbl sys

    93261............................. Interrogate subq defib

    93644............................. Electrophysiology evaluation

    97610............................. Low frequency non-thermal us

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

    ii. Common Refinements

    Table 31 details our refinements of the RUC's direct PE recommendations at the code-specific level. In this section, we discuss the general nature of some common refinements and the reasons for particular refinements.

    (a) Changes in Physician Time

    Some direct PE inputs are directly affected by revisions in work time described in section II.E.3.a. of this final rule with comment period. We note that for many codes, changes in the intraservice portions of the work time and changes in the number or level of postoperative visits included in the global periods result in corresponding changes to direct PE inputs. We also note that, for a significant number of services, especially diagnostic tests, the procedure time assumptions used in determining direct PE inputs are distinct from, and therefore not dependent on, work intraservice time assumptions. For these services, we do not make refinements to the direct PE

    Page 67672

    inputs based on changes to estimated work intraservice times.

    Changes in Intraservice Work Time in the Nonfacility Setting. For most codes valued in the nonfacility setting, a portion of the clinical labor time allocated to the intraservice period reflects minutes assigned for assisting the practitioner with the procedure. To the extent that we are refining the times associated with the intraservice portion of such procedures, we have adjusted the corresponding intraservice clinical labor minutes in the nonfacility setting.

    For equipment associated with the intraservice period in the nonfacility setting, we generally allocate time based on the typical number of minutes a piece of equipment is being used, and therefore, not available for use with another patient during that period. In general, we allocate these minutes based on the description of typical clinical labor activities. To the extent that we are making changes in the clinical labor times associated with the intraservice portion of procedures, we have adjusted the corresponding equipment minutes associated with the codes.

    Changes in the Number or Level of Postoperative Office Visits in the Global Period. For codes valued with postservice office visits during a global period, most of the clinical labor time allocated to the postservice period reflects a standard number of minutes allocated for each of those visits. To the extent that we are refining the number or level of postoperative visits, we have modified the clinical staff time in the postservice period to reflect the change. We note that until the global periods are transitioned, consistent with other policies finalized in this rule, we will make these refinements. For codes valued with postservice office visits during a global period, we allocate standard equipment for each of those visits. To the extent that we are making a change in the number or level of postoperative visits associated with a code, we have adjusted the corresponding equipment minutes. For codes valued with postservice office visits during a global period, a certain number of supply items are allocated for each of those office visits. To the extent that we are making a change in the number of postoperative visits, we have adjusted the corresponding supply item quantities associated with the codes. We note that many supply items associated with postservice office visits are allocated for each office visit (for example, a minimum multi-specialty visit pack (SA048) in the CY 2015 direct PE input database). For these supply items, the quantities in the direct PE input database should reflect the number of office visits associated with the code's global period. However, some supply items are associated with postservice office visits but are only allocated once during the global period because they are typically used during only one of the postservice office visits (for example, pack, post-op incision care (suture) (SA054) in the direct PE input database). For these supply items, the quantities in the direct PE input database reflect that single quantity.

    These refinements are reflected in the final CY 2015 PFS direct PE input database and detailed in Table 31.

    (b) Equipment Minutes

    In general, the equipment time inputs reflect the sum of the times within the intraservice period when a clinician is using the piece of equipment, plus any additional time the piece of equipment is not available for use for another patient due to its use during the designated procedure. In cases where equipment times included time for clinical labor activities in the pre-service period, we have refined these times to remove the minutes associated with these tasks, since the pre-service period ends ``when patient enters office/facility for surgery/procedure.'' Although some services include equipment that is typically unavailable during the entire clinical labor service period, certain highly technical pieces of equipment and equipment rooms are less likely to be used by a clinician for all tasks associated with a service, and therefore, are typically available for other patients during the preservice and postservice components of the service period. We adjust those equipment times accordingly. We refer interested stakeholders to our extensive discussion of these policies in the CY 2012 PFS final rule with comment period (76 FR 73182-73183) and in section II.G.2.b. of this final rule with comment period. We are refining the CY 2015 RUC direct PE recommendations to conform to these equipment time policies. These refinements are reflected in the final CY 2015 PFS direct PE input database and detailed in Table 31.

    (c) Moderate Sedation Inputs

    In the CY 2012 PFS final rule (76 FR 73043-73049), we finalized a standard package of direct PE inputs for services where moderate sedation is considered inherent in the procedure. In section II.A. of this 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 refining the CY 2015 RUC 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 2015 PFS direct PE input database and detailed in Table 31.

    (d) Standard 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 recommended direct PE inputs on ``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. At times, the RUC recommends a number of minutes either greater than or less than the time typically allotted for certain tasks. In those cases, CMS reviews the deviations from the standards to assess whether they are clinically appropriate. Where the RUC-recommended exceptions are not accepted, we refine the interim final 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 or other evaluation service, we remove the preservice clinical labor tasks so that the inputs are not duplicative and reflect the resource costs of furnishing the typical service.

    In some cases the RUC recommendations include additional minutes described by a category called ``other clinical activity,'' or through the addition of clinical labor tasks that are different from those previously included as standard. In these instances, CMS reviews the tasks as described in the recommendation to determine whether they are already incorporated into the total number of minutes based on the standard tasks. Additionally, CMS reviews these tasks in the context of the kinds of tasks delineated for other services under the PFS. For those tasks that are duplicative or not separately incorporated for other services, we do not accept those additional clinical labor tasks as direct inputs. For example, as we have previously discussed (78 FR 74308), we believe that quality assurance documentation tasks for services across the PFS are already accounted for in the overall estimate of clinical labor time. We do not believe that it would serve the relativity of the direct PE input database were additional minutes added for each clinical task that

    Page 67673

    could be discretely described for every code. These refinements are reflected in the final CY 2015 PFS direct PE input database and detailed in Table 31.

    (e) 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 CMS's pricing of that item by working with the specialty societies to provide sales invoices to us.

    We received invoices for several new supply and equipment items for CY 2015. We have accepted the majority of these items and added them to the direct PE input database. Tables 29 and 30 detail the invoices received for new and existing items in the direct PE database. As discussed in section II.A. of this final rule with comment period, we encourage stakeholders to review the prices associated with these new and existing items to determine whether these prices appear reasonable. Where prices appear unreasonable, we encourage stakeholders to provide invoices that provide more accurate pricing for these items in the direct PE database. We remind stakeholders that due to the budget neutral nature of the PFS, increased prices for any items in the direct PE database decrease the pool of PE RVUs available to all other PFS services. Tables 29 and 30 also include the number of invoices received as well as the number of nonfacility allowed services for procedures that use these equipment items. In cases where large numbers of allowed services exist, we question pricing the item based upon a single invoice. We are concerned that the single invoice may not be reflective of typical costs for these items and encourage stakeholders to provide additional invoices.

    In some cases we cannot adequately price a newly recommended item due to inadequate information. In some cases, no supporting information regarding the price of the item has been included in the recommendation to create a new item. In other cases, the supporting information does not demonstrate that the item has been purchased at the listed price (for example, price quotes instead of paid invoices). In cases where the information provided allowed us to identify clinically appropriate proxy items, we have used existing items as proxies for the newly recommended items. In other cases, we have included the item in the direct PE input database without an associated price. Although including the item without an associated price means that the item does not contribute to the calculation of the PE RVU for particular services, it facilitates our ability to incorporate a price once we are able to do so.

    Table 29--Invoices Received for New Direct PE Inputs

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

    Non-facility allowed

    services for HCPCS codes

    CPT/HCPCS codes Item name CMS code Average price No. of using this item (or

    invoices projected services for

    new CPT codes*)

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

    20604, 20606, 20611.................... ultrasound transmission SJ089 $1.71.......................... 1 748248*

    gel, sterile.

    (single use)..............

    22512.................................. 10g IVAS drill............ SD292 139.33......................... 1 99*

    22512.................................. 10g cannulae.............. SD293 86.11.......................... 1 99*

    29200, 29240, 29260, 29280, 29520, foam underwrap............ SG097 0.0043 per inch................ 1 415513

    29530, 29540, 29550.

    29200, 29240, 29260, 29280, 29520, rigid strapping tape (15 SG098 0.018 per inch................. 1 415513

    29530, 29540, 29550. yards).

    29200, 29240, 29260, 29280, 29520, skin prep barrier wipes... SM029 0.20........................... 1 415513

    29530, 29540, 29550.

    31620.................................. Flexible dual-channeled EQ361 160,260.06..................... 6 107

    EBUS bronchoscope, with

    radial probe.

    31620.................................. Video system, Ultrasound ER099 13,379.57...................... 6 107

    (processor, digital

    capture, monitor,

    printer, cart).

    31620.................................. EBUS, single use SC10145.82......................... 5 107

    aspiration needle, 21 g.

    31620.................................. Balloon for Bronchosopy SD294 28.68.......................... 4 107

    Fiberscope.

    52441, 52442........................... Urolift Implant and SD291 775.00......................... 10 12*

    implantation device.

    64486, 64488........................... ultrasound needle......... SC1012.81.......................... 4 46851*

    64487, 64489........................... continuous peripehral SA116 23.69.......................... 1 802*

    nerve block tray.

    77063.................................. multimodality software.... ED051 11,570.00...................... 12 297529*

    88341.................................. Anti CD45 Monoclonal SL495 3.61 per test.................. 1 917673*

    Antibody.

    88344.................................. 34 Beta E12............... SL496 4.27 per test.................. 1 51591*

    88348.................................. Digital Printer........... ED048 774.89......................... 1 641

    88348.................................. Carbon Coater............. EQ366 22,540.08...................... 1 641

    88348.................................. Diamond Milling Tool...... EQ365 1,714.00....................... 1 641

    88356, 88348........................... Electron Microscopy Tissue EP115 13,119.00...................... 2 19134

    processor.

    88356, 88348........................... Block face milling machine EQ363 18,139.00...................... 1 19134

    88356, 88348........................... Glass Knife Breaker....... EQ364 9,585.14....................... 1 19134

    88364.................................. CMV DNA Probe Cocktail.... SL500 0.10 per ul.................... 1 3376*

    88341, 88342, 88344, 88364, 88365, Universal Detection Kit... SA117 4.00........................... 1 1380597

    88367, 88368, 88369, 88373.

    88365.................................. EBER positive control SL507 20.15.......................... 1 8440

    slide.

    88365.................................. (EBER) DNA Probe Cocktail. SL497 8.57 per test.................. 2 8440

    Page 67674

    88365, 88366, 88367, 88368, 88374, VP-2000 Processor......... EP116 30,800.00...................... 1 228243

    88377.

    88367, 88368........................... Kappa Probe Cocktails..... SL498 0.10 per ul.................... 1 36634

    88369, 88373........................... Lambda Probe Cocktail..... SL499 0.10 per ul.................... 1 24423*

    88380, 88381........................... Surface Decontaminant (DNA SL494 0.07 per ml.................... 1 6649

    Away).

    91200.................................. Fibroscan................. ER101 124,950.00..................... 1 87*

    92145.................................. Ocular Response Analyzer.. EQ360 12,000.00...................... 3 Unknown

    92541, 92542, 92544, 92545............. VNG Recording System...... EQ367 29,607.50...................... 2 101139

    93702.................................. BIS monitoring system EQ359 3,316.93....................... 1 Unknown

    (bioimpedance

    spectroscopy).

    93702.................................. electrode, BIS SD290 28.33.......................... 1 Unknown

    (bioimpedance

    spectroscopy).

    96127.................................. Beck Youth Inventory, SK119 1.96 per booklet............... 1 Unknown

    Second Edition (BYI-II);

    Combination Inventory

    Booklet.

    97610.................................. MIST Therapy System....... EQ372 28,000.00...................... 2 2*

    97610.................................. MIST Therapy Cart......... EQ368 1,250.00....................... 1 2*

    97610.................................. kit, low frequency SA119 63.33.......................... 3 2*

    ultrasound wound therapy

    (MIST).

    99188.................................. CavityShield 5% Varnish SH106 0.91........................... 1 Unknown

    .25mL.

    G0277.................................. HBOT air break breathing EQ362 986.00......................... 1 153044*

    apparatus demand system

    (hoses, masks, penetrator

    and demand valve).

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

    Table 30--Invoices Received for Existing Direct PE Inputs

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

    Non-facility

    allowed

    CPT/HCPCS codes Item name CMS code Current price Updated price % Change No. of services for

    invoices HCPCS codes

    using this item

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

    20983, 47383..... cryosurgery EQ302 missing.................... $37,500.00................. ............ 2 22 *

    system (for

    tumor ablation).

    20983, 47383..... gas, argon...... SD227 $0.25 per cubic foot....... 0.32 per cubic foot........ 28 1 22 *

    20983, 47383..... gas, helium..... SD079 0.25 per cubic foot........ 0.57 per cubic foot........ 128 1 22 *

    31627............ system, EQ326 137,800.00................. 189,327.66................. 37 4 37

    navigational

    bronchoscopy

    (superDimension

    ).

    31627............ kit, locatable SA097 995.00..................... 1,063.67................... 7 3 37

    guide, ext.

    working

    channel, w-b-

    scope adapter.

    64561............ kit, SA022 305.00..................... 420.00..................... 38 1 8229

    percutaneous

    neuro test

    stimulation.

    88348............ camera, digital ED006 41,000.00.................. 82,000.00.................. 100 1 641

    system, for

    electron

    microscopy.

    88348, 88356..... microtome, ultra ER043 25,950.00.................. 34,379.00.................. 32 1 19134

    G0277............ HBOT (hyperbaric EQ131 125,000.00................. 127,017.98................. 2 1 153044 *

    oxygen therapy)

    monochamber,

    incl. gurney

    and integrated

    grounding

    assembly.

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

    * New procedure--Projected volume.

    Page 67675

    (f) Recommended Items That Are Not Direct PE Inputs

    In some cases, the recommended direct PE inputs included items that are not clinical labor, disposable supplies, or medical equipment resources. We have addressed these kinds of recommendations in previous rulemaking and in sections II.G.2.b. and II.B.4.a. of this final rule with comment period. Refinements to adjust for these recommended inputs are reflected in the final CY 2015 PFS direct PE input database and detailed in Table 31.

    (g) Film-to-Digital Migration

    As discussed in section II.A.3 of this final rule with comment period, we are finalizing our policy to remove equipment and supply inputs associated with film technology from the direct PE database. Since the recommendations we received for 2015 were prepared before the transition occurred, in some cases, the RUC recommendations included film inputs. Where recommendations included these inputs, we have removed these inputs and replaced them with ``PACS workstation proxy'' as described in section II.A.3 of this final rule with comment period. Since the film-to-digital transition results from our acceptance of a RUC recommendation, we do not consider the removal of these items to be refinements of RUC recommendations, and therefore do not include them in Table 31.

    (h) Pre-Service and Post-Service Tasks for Add-On Codes

    In general, we believe that certain pre-service and post-service tasks are not repeated for services reported using add-on codes. In some cases, we also believe that the time for certain equipment items are not duplicated for add-on codes. In these cases, we removed the time associated with those tasks and/or equipment items from those codes. These refinements appear in Table 31.

    iii. Code-Specific Refinements

    (a) Rib Fractures (CPT Codes 21811, 21812, and 21813)

    For the newly created rib fracture codes, which are frequently furnished as emergency surgeries, the RUC did not include time for the standard pre-service activities ``Provide pre-service education/obtain consent'' and ``Follow-up phone calls & prescriptions.'' However, the RUC recommendation included time for pre-service activities ``Complete pre-service diagnostic & referral forms,'' ``Coordinate pre-surgery services'', and ``Schedule space and equipment in facility.'' Since these codes would typically be provided as emergency surgeries, we question whether these tasks would typically be performed.

    We reviewed other emergency procedures in the PFS to determine whether pre-service clinical labor activities were typically included in the PE worksheets. We found that the recommendations for these procedures were inconsistent. Therefore, we will not remove the time allocated for these clinical labor activities at this time. However, we believe that for emergency procedures, none of the pre-service tasks listed above would typically be performed. We seek comment to clarify this issue, and plan to consider this issue in future rulemaking.

    As discussed earlier in this section of this final rule with comment period, we have valued CPT codes 21811, 21812, and 21813 as 0-

    day globals. We have therefore removed direct PE inputs associated with the postoperative visits.

    (b) Percutaneous Vertebroplasty and Augmentation (CPT Codes 22510, 22511, 22512, 22513, 22514, and 22515)

    The RUC recommendation regarding add-on CPT code 22512 (Percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance, each additional cervicothoracic or lumbosacral vertebral body)) included new supply item ``10g IVAS drill.'' We note that the recommendations for the base codes did not contain this supply item, and the vertebroplasty kit does not appear to contain this drill either. We do not understand why the drill would be required for the add-on code when it is not required for the base code. Therefore, we will not include supply item ``10g IVAS drill'' in CPT code 22512 at this time.

    (c) Endobronchial Ultrasound (EBUS) (CPT Code 31620)

    As indicated earlier in this section of this final rule with comment period, we are maintaining the CY 2014 work RVU for CPT code 31620 in light of our concerns regarding coding structure. As such, we are maintaining the CY 2014 direct PE inputs for 31620 as well.

    (d) Breast Tomosynthesis (CPT Codes 77061, 77062, and 77063)

    For CY 2015, the CPT Editorial Panel created three codes to describe digital breast tomosynthesis services: 77061(Digital breast tomosynthesis; unilateral), 77062 (Digital breast tomosynthesis; bilateral) and 77063 (Screening digital breast tomosynthesis, bilateral (List separately in addition to code for primary procedure)). For these newly created codes, the RUC recommended creating a new equipment item, ``room, breast tomosynthesis'', at a price of $667,669, as well as a list of items contained in the room. We believe that several of the items included in the room are not appropriately characterized as direct costs. We also believe that the creation of rooms sometimes causes confusion when items in the room are also included as stand-

    alone PE inputs, as specialty societies do not consider the items included in the room when preparing the PE worksheets. Further, we believe that the prices for the rooms sometimes result in less transparency, as prices for items within the room tend to remain static over time. Therefore, we are not creating this new equipment item, but will instead include the individual equipment items that we believe are appropriately characterized as direct costs.

    The price for the digital breast tomosynthesis unit indicated on the invoice received by the RUC was $498,412. We received many invoices for this equipment item with an average price of $381,380. Therefore, we will create a new equipment item ``DBT unit'', at a price of $381,380.

    The RUC also recommended including a new equipment item, ``PACS cache'', for these procedures. We do not believe that digital storage constitutes a direct cost, as it is not individually allocable to an individual patient for a particular service. . Therefore, we will not add this new equipment item to the direct PE database.

    (e) Radiation Treatment (CPT Codes 77385, 77386, 77387, 77402, 77407, 77412)

    For CY 2015, the CPT Editorial Panel revised the set of codes that describe radiation treatment delivery services. These revisions included the addition and deletion of several codes and the development of new guidelines and coding instructions. Due to the significant code restructuring and potential for changes in payment, some specialty societies representing providers of radiation treatment services have requested that we delay implementation of the new code set. We believe that given the large scale of the changes in this code set restructuring, in the context of our upcoming revised process for valuing new, revised, and potentially misvalued codes, it is prudent to propose the values for the revised code set in the CY 2016 rule

    Page 67676

    with opportunity for public comment prior to establishing payment rates.

    (f) Immunohistochemistry (CPT Codes 88341, 88342, and 88344)

    The RUC recommended including supply item ``UltraView Universal DAB Detection Kit'' (SL488) for CPT codes 88341, 88342, and 88344, which is priced at $10.49 per kit, and ``UltraView Universal Alkaline Phosphatase Red Detection Kit'', which is priced at $20.64. We noted that for other similar services, CPT codes 88364, 88365, 88367, 88368, 88369, and 88373, the RUC recommended including supply item ``Universal Detection Kit'' (SA117), which is priced at $4.00 per kit. After reviewing information about these two kits, we believe that functions provided by SL488 and SL489 are also provided by SA117. The recommendations did not explain why the more expensive kit was necessary for 88341, 88342, and 88344 when the less expensive kit was sufficient for CPT codes 88364, 88365, 88367, 88368, 88369, and 88373. Absent any rationale for the use of the more expensive kit, we are including SA117 for 88341, 88342, and 88344 in place of SL488.

    (g) Electron Microscopy (CPT Code 88348)

    The RUC recommended including a new supply item, ``diamond milling tool'', for use with CPT code 88348. However, upon reviewing the invoice, we believe that ``diamond milling tool'' is more appropriately characterized as equipment. We have therefore created an equipment item for this tool, as listed in Table 29.

    (h) Morphometric Analysis (CPT Codes 88364, 88365, 88366, 88367, 88373, 88374, 88377, 88368, and 88369)

    The CPT Editorial Panel revised the in situ hybridization codes (88365, 88367, and 88368) and created three new add-on codes for reporting each additional separately identifiable probe per slide. The RUC reviewed CPT codes 88365, 88367, and 88368, among other services in this family, in October 2013 and recommended direct inputs for these procedures, including supply item ``kit, FISH paraffin pretreatment'' (SL195), with quantities of 1 unit for CPT code 88365, 0.75 units for CPT code 88367, and 1 unit for CPT code 88368.

    After the CY 2014 PFS final rule with comment period was published, the specialty societies determined that additional clarification was necessary, and requested that the CPT Editorial Panel review the entire family again. The CPT editorial panel added three new codes for ``each multiplex probe stain procedure.'' The specialty societies then resurveyed these procedures. The RUC reviewed the entire family at the April 2014 meeting and recommended supply item SL195 with a quantity of 2 units for CPT code 88365, 1.4 units for CPT code 88367, and 2 units for CPT code 88368. These quantities are double what the RUC recommended to us in October 2013, which was 1 unit for CPT code 88365, 0.75 units for CPT code 88367, and one unit for CPT code 88368. Without an explanation for this significant change, we are including SL195 with the following quantities: 1 unit for CPT code 88365, 0.75 units for CPT code 88367, and 1 unit for CPT code 88368. Similarly, for add-on services CPT codes 88364, 88366, 88369, 88373, 88374, and 88377, more than one unit of SL195 was included. We believe that the unit of the kit should be consistent between the base code and the add-on code. We will therefore include 1 unit of SL195 for CPT codes 88364, 88366, 88369, and 88377, and 0.75 units for CPT codes 88373 and 88374. We are also interested in learning more about why a partial kit would be used in furnishing the typical service.

    CPT codes 88374 and 88377, which are add-on codes, contain more than one unit of supply item ``kit, HER-2/neu DNA Probe'' (SL196). Because these codes describe a service that includes a single specimen with one stain, we do not understand why more than one kit would be required. We have therefore included a unit of 1 for SL196 in CPT codes 88374 and 88377.

    We also believe that the units of positive control slides and negative control slides should be consistent throughout this entire family. We note that CPT codes 88367, 88373, and 88374 included a recommended 0.2 units of positive and/or negative control slide; supply items SL118 and SL119 for CPT code 88367, supply items SL120 and SL121 for CPT code 88373, and supply items SL184 and SL185 for CPT code 88374.) However, for CPT codes 88368, 88369, and 88377, the recommendation included 0.5 units of the positive and/or negative control slide (supply item SL112 for CPT codes 88368 and 88369, and supply items SL184 and SL185 for CPT code 88377). No rationale was provided for why a greater quantity of the control slide would be required. Therefore, we will include 0.2 units of positive and/or negative control slides, as appropriate, to maintain consistency throughout this family of codes.

    As with the positive and negative control slides, we believe that the number of units of supply item SL498 (``Kappa probe cocktails'') and SL499 (Lambda probe cocktails'') should be consistent across procedures. The recommendations for CPT codes 88367 and 88373 contain 28 ul of SL498 for 88367 and 27 ul of SL499 for 88373. Therefore, to maintain consistency, we refined the units of SL498 for CPT code 88368 and SL499 for CPT code 88369 to 28 ul.

    The RUC recommended a quantity of 1.6 for SL497 ``(EBER) DNA Probe Cocktail'' for CPT code 88365. Since this procedure describes a single stain, and the stain needs to be added to the positive control slide and the specimen slide, we believe that a quantity of 2 is more appropriate. We have therefore included 2 units of SL497 for CPT code 88365.

    The RUC recommendation also included a new equipment item ``VP-2000 processor'' (EP116). Among the purposes of this equipment item is to reduce the amount of technician time needed to complete the clinical labor task. However, in the recommendations we received, rather than the clinical labor time for these codes decreasing with the addition of this new equipment item, the RUC recommended increased clinical labor times associated with this task for CPT codes 88365, 88366, 88368, and 88377 increased. We are unable to reconcile as typical the new equipment item, which is intended to reduce technician time, with the increased technician time for this same clinical labor task. Therefore, we will not allocate time for equipment item ``VP-2000 processor'' (EP116) in CPT codes 88365, 88366, 88368, and 88377.

    (h) Microdissection (CPT Codes 88380 and 88381)

    In reviewing the RUC recommendations for CPT code 88380, the work vignette indicated that the microdissection is performed by the pathologist. However, the PE worksheet also included several subtasks of ``Microdissect each stained slide sequentially while reviewing H and E stained slide'' that are performed by the cytotechnologist. Since we do not believe that both the pathologist and the cytotechnologist are completing these tasks, we have refined out the lines associated with the specific tasks we believe are completed by the pathologist. Table 31 details our refinements to the clinical labor tasks.

    (j) Interventional Transesophageal Echocardiography (TEE) (CPT Codes 93312 and 93314)

    CPT code 93314 describes a service in which the acquisition and interpretation of images is furnished by a different practitioner than the placement of the

    Page 67677

    probe. CPT code 93312 includes all services encompassed by CPT code 93314 and included a recommendation for 30 minutes of assist physician time. We do not believe that CPT code 93314 should have more clinical labor than CPT code 93312, which is the more extensive code. We have therefore refined this time to 30 minutes, which is the same as the time allocated to 93312. We also note that the time allocated to equipment item ``room, ultrasound, vascular'' (EL016) was affected by this refinement.

    (k) Hyperbaric Oxygen Therapy (HBOT) (HCPCS Code G0277)

    We received a RUC recommendation for CPT code 99183 (Physician or other qualified health care professional attendance and supervision of hyperbaric oxygen therapy, per session), which included significant increases to the direct PE inputs, which assumes a treatment time of 120 minutes. Currently, CPT code 99183 is used for both the professional attendance and supervision and the actual treatment delivery. Stakeholders have pointed out that although we include the PE inputs for treatment delivery in this code, the descriptor describes only attendance and supervision. We note that under the OPPS, the treatment is reported using separate treatment code C1300 (Hyperbaric oxygen under pressure, full body chamber, per 30 minute interval). After considering this issue, we believe the OPPS approach would also be appropriate for the PFS. We are therefore creating a G-code to report the treatment delivery and to maintain consistency with the OPPS coding. We will use the same descriptor as previously used for OPPS code C1300 for a timed 30-minute code, which can then be used across settings. To value this G-code, we used the RUC recommended direct PE inputs for 99183 and adjusted them to align with the 30 minute treatment interval.

    In reviewing the recommended direct PE inputs, we observed that the quantity of oxygen increased significantly relative to the previous value. To better understand this change, we reviewed the instruction manual for the most commonly used HBOT chamber, which provide guidance regarding the quantity of Oxygen used. Based on our review, we determined that 12,000, rather than 47,000, was the typical number of units. Therefore, in aligning the direct PE inputs as described above, we first adjusted the units of oxygen to 12,000 for the recommended 120 minute time, and subsequently adjusted it to align with the 30 minute G-code.

    (l) EOG VNG (CPT code 92543)

    As described earlier in this section of this final rule with comment period, we are maintaining the CY 2014 work RVU for CPT code 92543 due to possible confusion among survey respondents. Similarly, we are also maintaining the CY 2014 direct PE inputs for 92543.

    These refinements, as well as other applicable standard and common refinements for these codes, are reflected in the final CY 2015 PFS direct PE input database and detailed in Table 31.

    BILLING CODE 4120-01-P

    Page 67678

    GRAPHIC TIFF OMITTED TR13NO14.019

    Page 67679

    GRAPHIC TIFF OMITTED TR13NO14.020

    Page 67680

    GRAPHIC TIFF OMITTED TR13NO14.021

    Page 67681

    GRAPHIC TIFF OMITTED TR13NO14.022

    Page 67682

    GRAPHIC TIFF OMITTED TR13NO14.023

    Page 67683

    GRAPHIC TIFF OMITTED TR13NO14.024

    Page 67684

    GRAPHIC TIFF OMITTED TR13NO14.025

    Page 67685

    GRAPHIC TIFF OMITTED TR13NO14.026

    Page 67686

    GRAPHIC TIFF OMITTED TR13NO14.027

    Page 67687

    GRAPHIC TIFF OMITTED TR13NO14.028

    Page 67688

    GRAPHIC TIFF OMITTED TR13NO14.029

    Page 67689

    GRAPHIC TIFF OMITTED TR13NO14.030

    Page 67690

    GRAPHIC TIFF OMITTED TR13NO14.031

    Page 67691

    GRAPHIC TIFF OMITTED TR13NO14.032

    Page 67692

    GRAPHIC TIFF OMITTED TR13NO14.033

    Page 67693

    GRAPHIC TIFF OMITTED TR13NO14.034

    Page 67694

    GRAPHIC TIFF OMITTED TR13NO14.035

    Page 67695

    GRAPHIC TIFF OMITTED TR13NO14.036

    Page 67696

    GRAPHIC TIFF OMITTED TR13NO14.037

    Page 67697

    GRAPHIC TIFF OMITTED TR13NO14.038

    Page 67698

    GRAPHIC TIFF OMITTED TR13NO14.039

    Page 67699

    GRAPHIC TIFF OMITTED TR13NO14.040

    Page 67700

    GRAPHIC TIFF OMITTED TR13NO14.041

    Page 67701

    GRAPHIC TIFF OMITTED TR13NO14.042

    Page 67702

    GRAPHIC TIFF OMITTED TR13NO14.043

    Page 67703

    GRAPHIC TIFF OMITTED TR13NO14.044

    Page 67704

    GRAPHIC TIFF OMITTED TR13NO14.045

    Page 67705

    GRAPHIC TIFF OMITTED TR13NO14.046

    Page 67706

    GRAPHIC TIFF OMITTED TR13NO14.047

    Page 67707

    GRAPHIC TIFF OMITTED TR13NO14.048

    Page 67708

    GRAPHIC TIFF OMITTED TR13NO14.049

    Page 67709

    GRAPHIC TIFF OMITTED TR13NO14.050

    Page 67710

    GRAPHIC TIFF OMITTED TR13NO14.051

    Page 67711

    GRAPHIC TIFF OMITTED TR13NO14.052

    Page 67712

    BILLING CODE 4120-01-C

    iii. Procedures Subject to the Cap on Imaging Codes Defined by Section 5102(b) of the DRA

    We are proposing to add the new codes to the list of procedures subject to the DRA cap, effective January 1, 2015. The codes are: (76641 (Ultrasound breast complete), 76642 (Ultrasound breast limited), 77085 (Dxa bone density study), 77086 (Fracture assessment via dxa), 77387 (Guidance for radiaj tx dlvr), G6001 (Stereoscopic x-ray guidance), and G6002 (Echo guidance radiotherapy). These codes, which are new for CY 2015, replace codes deleted for CY 2015 that were subject to the cap, and meet the definition of imaging under section 5102(b) of the DRA. These codes are being added on an interim final basis and are open to public comment in this final rule with comment period.

  40. Establishing CY 2015 Interim Final Malpractice RVUs

    According to our malpractice methodology discussed in section II.C, we are assigning malpractice RVUs for CY 2015 new, revised, and potentially misvalued codes by utilizing a crosswalk to a source code with a similar malpractice risk. We have reviewed the RUC recommended malpractice source code crosswalks for CY 2015 new, revised, and potentially misvalued codes, and we are accepting all of them on an interim final basis for CY 2015. For G-codes that we are creating, we are also assigning source code crosswalks to similar codes.

    Table 32 lists the CY 2015 HCPCS codes and their respective source codes used to set the interim final CY 2015 MP RVUs. The MP RVUs for these services are reflected in Addendum B of this CY 2015 PFS final rule with comment period.

    BILLING CODE 4120-01-P

    Page 67713

    GRAPHIC TIFF OMITTED TR13NO14.053

    Page 67714

    GRAPHIC TIFF OMITTED TR13NO14.054

    Page 67715

    GRAPHIC TIFF OMITTED TR13NO14.055

    BILLING CODE 4120-01-C

    1. Chronic Care Management (CCM)

      As we discussed in the CY 2013 PFS final rule with comment period, 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 payment for, and encourage long-term investment in, care management services. These initiatives include the following programs and demonstrations:

      The Medicare Shared Savings Program (described in ``Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations; Final Rule,'' which appeared in the November 2, 2011 Federal Register (76 FR 67802)).

      The testing of the Pioneer ACO model, designed for experienced health care organizations (described on the Centers for Medicare and Medicaid Innovation's (Innovation Center's) Web site at http://innovation.cms.gov/initiatives/Pioneer-ACO-Model/index.html).

      The testing of the Advance Payment ACO model, designed to support organizations participating in the Medicare Shared Savings Program (described on the Innovation Center's Web site at http://innovation.cms.gov/initiatives/Advance-Payment-ACO-Model/).

      The Primary Care Incentive Payment (PCIP) Program (described on the CMS Web site at www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/PCIP-2011-Payments.pdf).

      The patient-centered medical home model in the Multi-payer Advanced Primary Care Practice (MAPCP) Demonstration designed to test whether the quality and coordination of health care services are improved by making advanced primary care practices more broadly available (described on the CMS Web site at www.cms.gov/Medicare/Demonstration-Projects/DemoProjectsEvalRpts/downloads/mapcpdemo_Factsheet.pdf).

      The Federally Qualified Health Center (FQHC) Advanced Primary Care Practice demonstration (described on the CMS Web site at http://www.cms.gov/Medicare/Demonstration-Projects/DemoProjectsEvalRpts/Downloads/FQHC_APCP_Demo_FAQsOct2011.pdf and the Innovation Center's Web site at www.innovations.cms.gov/initiatives/FQHCs/index.html).

      The Comprehensive Primary Care (CPC) initiative (described on the Innovation Center's Web site at http://innovations.cms.gov/initiatives/Comprehensive-Primary-Care-Initiative/index.html). The CPC initiative is a multi-payer initiative fostering collaboration between public and private health care payers to strengthen primary care in certain markets across the country.

      In addition, HHS leads a broad initiative focused on optimizing health and quality of life for individuals with multiple chronic conditions. HHS's Strategic Framework on Multiple Chronic Conditions outlines specific objectives and strategies for HHS and private sector partners centered on strengthening the health care and public health systems; empowering the individual to use self-care management with the assistance of a healthcare provider who can assess the patient's health literacy level; equipping care providers with tools, information, and other interventions; and supporting targeted research about individuals with multiple chronic conditions and effective interventions. Further information on this initiative is available on the HHS Web site at http://www.hhs.gov/ash/initiatives/mcc/index.html.

      In coordination with all of these initiatives, 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. For example, in the CY 2013 PFS final rule with comment period, we adopted a policy to pay separately for care management involving the transition of a beneficiary from care furnished by a treating physician during a hospital 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 to pay separately for care management services furnished to Medicare beneficiaries with two or more chronic

      Page 67716

      conditions beginning in CY 2015 (78 FR 74414).

      1. Valuation of CCM Services--GXXX1

      CCM is a unique PFS service designed to pay separately for non-

      face-to-face care coordination services furnished to Medicare beneficiaries with multiple chronic conditions. (See 78 FR 74414 for a more thorough discussion of the beneficiaries for whom this service may be billed and the scope of service elements.) In the CY 2014 PFS final rule with comment period, we indicated that, to recognize the additional resources required to furnish CCM services to patients with multiple chronic conditions, we were creating the following code to use for reporting this service (78 FR 74422):

      GXXX1 Chronic care management services furnished to patients with multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient, that place the patient at significant risk of death, acute exacerbation/

      decompensation, or functional decline; 20 minutes or more; per 30 days.

      Although this service is unique in that it was created to separately pay for care management services, other codes include care management components. To value CCM, we compared it to other codes that involve care management. In doing so, we concluded that the CCM services were similar in work (time and intensity) to that of the non-

      face-to-face portion of the lower level code for transitional care management (TCM) services (CPT code 99495 (Transitional Care Management Services with the following required elements: Communication (direct contact, telephone, electronic) with the patient and/or caregiver within 2 business days of discharge Medical decision making of at least moderate complexity during the service period face-to-face visit, within 14 calendar days of discharge)). Accordingly, we based the proposed inputs on the non-face-to-face portion of CPT code 99495.

      Specifically, we proposed a work RVU for GXXX1 of 0.61, which is the portion of the work RVU for CPT code 99495 that remains after subtracting the work attributable to the face-to-face visit. (CPT code 99214 (Office/outpatient visit est) was used to value CPT code 99495, which has a work RVU of 1.50). Similarly, we proposed a work time of 15 minutes for HCPCS code GXXX1 for CY 2015 based on the time attributable to the non-face-to-face portion of CPT 99495.

      For direct PE inputs, we proposed 20 minutes of clinical labor time. As established in the CY 2014 PFS final rule with comment period, in order to bill for this code, at least 20 minutes of CCM services must be furnished during the 30-day billing interval (78 FR 74422). Based upon input from stakeholders and the nature of care management services, we believed that many aspects of this service will be provided by clinical staff, and thus, clinical staff would be involved in the typical service for the full 20 minutes. CPT code 99495 has 45 minutes of non-face-to-face clinical labor time and we assumed the typical case for CCM would involve 20 minutes based upon the code descriptor and a broad eligible population that would require limited monthly services. The proposed CY 2015 direct PE input database reflected the input of 20 minutes of clinical labor time and is available on the CMS Web site under the supporting data files for the CY 2015 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. The resulting proposed PE RVUs were 0.57 for CCM furnished in non-facility locations and 0.26 for CCM furnished in a facility.

      The proposed MP RVU of 0.04 was calculated using the weighted risk factors for the specialties that we believed would furnish this service. We believed the proposed malpractice risk factor would appropriately reflect the relative malpractice risk associated with furnishing CCM services.

      We received many public comments on our proposed valuation. In general, the commenters commended CMS for ongoing recognition of the value of non-face-to-face time expended by physicians and staff to improve outcomes for beneficiaries with chronic conditions, and the proposal to pay separately for the non-face-to-face services. However, the commenters generally believed the proposed valuation for CCM services underestimated the resources involved with complex beneficiaries, and recommended various alternatives for valuing the services. We summarize these comments in the following paragraphs.

      Comment: Several commenters noted that the CPT Editorial Panel created a new code for CY 2015 that is extremely similar to the G-code we developed to report these services. These commenters suggested that we use the new 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).

      Many of these commenters expressed a preference for the ``per calendar month'' used in the CPT descriptor to the ``per 30 days'' used in the G-code. The commenters said a calendar month rather than 30 days would be less complex administratively.

      Response: It is our preference to use CPT codes unless Medicare has a programmatic need that is not met by the CPT coding structure. Accordingly, in the CY 2014 final rule with comment period we indicated that we would consider using a CPT code if one was created that reflected the service we were describing with the G-code. We believe that the new CPT code 99490 appropriately describes CCM services for Medicare beneficiaries.

      We had used 30 days rather than a calendar month as the service period for the G-code so that the number of days in the service period would not vary based upon when CCM services were initiated for a given period. For example, if the services were initiated near the end of a calendar month, using the CPT code's period of ``per calendar month'' would make it harder for the practitioner to meet the required minimum time for the month and be able to bill CMM for that month.

      However, after learning about the administrative difficulties that the 30-day period would create, we believe that the calendar month creates a reasonable period. Accordingly, we will adopt CPT code 99490 for Medicare CCM services, effective January 1, 2015 instead of the G code.

      Comment: Several commenters suggested alternative approaches to the use of codes that describe CCM services. For example, one commenter said that the code should be for one year, with average of 20 minutes per month across the year. Another commenter was concerned about how the 20 minutes of care per month per patient will be calculated, because some patients (those whose condition is less well controlled) will demand more attention and care than average patients, while those whose condition is well controlled might require very little attention. This commenter suggested that a reasonable solution would be for the care minutes per patient per month to be calculated as an average across a number of CCM

      Page 67717

      patients. The commenter added that for patients entering and exiting mid-month, the average minutes of care could be calculated on a pro rata basis which adjusts for the partial months they are eligible for CCM services. Several other commenters said that CMS should use a capitated payment methodology for CCM services in the long run, but supported CCM services using the CPT codes as valued by the RUC as a short-term transitional strategy until CMS is able to expand the per beneficiary per month care management fee under CMS's primary care demonstration initiatives to all physicians. Others commented similarly that the long-term goal is capitated payments like the demonstrations/

      models that better encourage population-based health management and reducing utilization.

      Several commenters submitted recommendations for valuation based on their experience in CMS's Patient-Centered Medical Home multipayer initiative. Assuming CCM services are furnished by a care manager receiving an annual salary of $150,000, and taking into account a commonly accepted patient to care manager ratio of 1:150, these commenters believed that under the proposed payment rate, the average service time possible would be a ceiling of 23 minutes (not a floor of 20 minutes). Based on one tracking study of care manager activity in minutes per patient per month, they believed complex care management would require 42 minutes of face-to-face and non-face-to-face time per month. Assuming the same care manger salary and patient load, the commenters asserted that the monthly payment amount necessary to provide this amount of care would be $83 per beneficiary per month.

      Response: Our proposal to pay separately for these services is part of a broader series of potential refinements to the PFS that appropriately value care management within Medicare's statutory structure for fee-for-service physician payment. We do not have statutory authority to base payment under the PFS on a recurring per beneficiary per month basis. The PFS is limited to a fee-for-service model at present, and as such we do not use capitated payment for services that may or may not be furnished in a given month. We refer the commenter and other interested stakeholders to the preceding paragraphs that describe a broader set of initiatives that are designed to improve payment for, and encourage long-term investment in, care management services, including a variety of CMS and HHS programs and demonstrations.

      Comment: Many commenters recommended a higher valuation for CCM services than was proposed, with some commenters providing specific suggestions as to changes in inputs and others simply asserting that a higher payment was appropriate or necessary to achieve access or the desired benefit. One commenter recommended a payment of $75 but did not provide supporting information. Several other commenters recommended that CMS adopt the RUC-recommended values for CPT code 99490 (work time of 30 minutes, work RVU of 1.0, and 60 minutes of clinical labor time). Several commenters believed CMS should adopt the work, PE and MP RVUs for CPT code 99495, with one commenter suggesting that CMS crosswalk the PE and MP RVU from the TCM code and not just the work RVU from the code in order to equalize payment for the CCM code with a per beneficiary per month payment that is made for similar services through a state Medicaid program. Another commenter pointed out that the proposed combined MP and PE RVU of 0.61 for CCM is significantly lower than for the following similar services that cannot be billed during same period with CCM: HCPCS code G0181 (Home Healthcare Oversight) which has a combined MP and PE RVU of 1.28; HCPCS code G0182 (Hospice Care Plan Oversight) which has a combined MP and PE RVU of 1.30; CPT code 99339 (Care Plan Oversight Services) which has a combined MP and PE RVU of 0.94; and CPT code 99358 (Prolonged Services without Direct Patient Contact) which has a combined MP and PE RVU of 0.98.

      Several commenters suggested that CMS's comparison with TCM, CPT code 99495, was not an appropriate comparison. One commenter asked what codes other than CPT code 99495 CMS considered as similar to CCM for purposes of CCM valuation. This commenter believed the time and intensity required for the non-face-to-face portion of CPT code 99495 is not the same as for CCM services.

      Several commenters suggested that CMS should develop PE RVUs for the service using alternative methodologies than for other PFS services. For example, several commenters stated that CMS should adjust the PE RVUs to account for major infrastructure and other costs required for CCM, especially health information technology, computer equipment, 24/7 beneficiary access, extensive documentation, nursing staff and other overhead costs. One commenter believed the proposed RVUs accounted for personnel costs but not the practice expense for health information technology, workforce retooling, and analytics.

      We received many public comments on the appropriate work time and direct PE inputs for clinical staff time. Most suggested that the proposed inputs for time were too low and recommended using the RUC-

      recommended values (work time of 30 minutes and 60 minutes of clinical labor time). Regarding clinical labor time, some commenters believed the proposed 20 minutes of clinical labor was too low, being the 25th percentile for work time in the RUC survey, and they noted the significantly higher time reported in response to the RUC survey of 60 minutes of clinical labor time. Another commenter said that assuming 20 minutes of service time per month as typical significantly undervalues the service and questioned how CMS arrived at that number. Regarding the work time, several commenters addressed the work RVU, recommending that the proposed RVU be adjusted upwards but did not specify by how much. Several commenters noted that the RUC recommendation of 1.0 work RVU for CPT codes 99490 and 99487 (Cmplx chron care w/o pt visit) is based on median survey work times of 30 minutes and 26 minutes, respectively, for these CCM codes. (The long descriptor for CPT code 99487 is, Complex chronic care management services, 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;

      Establishment or substantial revision of a comprehensive care plan;

      Moderate or high complexity medical decision making;

      60 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month).

      However several commenters did not object to the proposed valuation for GXXX1 and recommended that CMS monitor payment adequacy and appropriate valuation once the code is implemented.

      Response: After consideration of the various comments on the work RVUs, we continue to believe that the most appropriate mechanism for determining the appropriate work RVU for this service is by using the non-face-to-face portion of the lower level TCM code, CPT code 99495. We continue to believe

      Page 67718

      that the work and intensity for CCM services furnished to the eligible beneficiaries is comparable to the work and intensity involved in furnishing the non-face-to-face portion of the service described by CPT code 99495. Therefore, we believe that using CPT code 99495 as the comparison code assures appropriate relativity with other similar services. The services suggested by the commenters as comparable to the CCM code require significantly more time. CPT code 99358 is for an hour of non-face-to-face time and has a work time of 60 minutes. CPT code 99339 has a work time of 40 minutes and is furnished to a significantly different patient population (those in a domiciliary or rest home). HCPCS codes G0181 and G0182 have work time of almost 60 minutes and also are furnished to significantly different patient populations.

      We appreciate commenters' concerns regarding the various kinds of practice expense and malpractice liability costs that practices incur as they manage beneficiaries requiring CCM services. However, we continue to believe that our established PE and MP methodology used to value the wide ranges of services across the PFS assures that we have the appropriate relativity in our payments.

      Although many commenters recommended that we use the time from the RUC survey of 60 minutes of clinical labor and 30 minutes of work time, we believe that since CCM is a new separately billable service, the survey data may be less reliable as the practitioners would have no experience with the code. Since at least 20 minutes of services are required to be furnished in order to report the service and our information, including comments, suggests that many beneficiaries who meet Medicare's criteria for CCM services would not need more than the minimum required minutes of service, we believe 60 minutes would overestimate the typical number of clinical labor minutes during one month for the typical eligible beneficiary. Accordingly, we are finalizing our proposed work and clinical labor times.

      Comment: A number of commenters recommended that coinsurance should not apply to CCM services. These commenters were concerned that the $8 estimated coinsurance amount in the proposed rule would hinder beneficiary access. Several commenters believed that CCM is a preventive service that should be exempt from beneficiary cost sharing. They noted that cost-sharing will make it challenging to reach the 20 minutes required for billing, because beneficiaries will delay care until face-to-face is necessary.

      Response: CCM services do not fall into any of the statutory preventive services benefit categories of the Act. The Secretary has the authority to add ``additional preventive services'' that, among other things, have been assigned an ``A'' or ``B'' rating by the United States Preventive Services Task Force, but CCM has not earned such a rating. Since CCM does not meet the criteria, we cannot designate it as an additional preventive service under section 1861(s)(2)(BB) of the Act. Further, we do not have other statutory authority that would allow us to waive the applicable coinsurance for CCM services. As discussed in the CY 2014 PFS final rule with comment period (78 FR 74424), in order to assure that beneficiaries are aware of the coinsurance for this non-face-to-face service, we are requiring that providers explain to beneficiaries the cost-sharing obligation involved in receiving CCM services and obtain their consent prior to furnishing the service. Practitioners should explain that a likely benefit of agreeing to receive CCM services is that although cost-sharing applies to these services, CCM services may help them avoid the need for more costly face to face services that entail greater cost-sharing.

      Comment: Most of the commenters were concerned that the proposed payment would not be adequate for beneficiaries with complex needs who would benefit the most from CCM services. Most of the commenters recommended that we adopt more than one code to provide differential payment for more and less complex beneficiaries, using CPT CCM codes, G-code(s) or some combination thereof. Many commenters distinguished between beneficiaries that require significantly different clinical resources--those needing ``complex chronic care management'' and those needing only ``standard chronic care or disease management.'' Some commenters asserted that there is a disconnect between the code descriptor for GXXX1 and the Medicare CCM scope of service, such that ambiguity in the descriptor will result in use of GXXX1 to treat a very broad spectrum of beneficiaries inconsistent with the scope of service that the commenters believed was consistent with beneficiaries with more complex needs. They believed the proposed payment amount is appropriate for beneficiaries on needing only standard chronic care management, but would significantly underpay for beneficiaries requiring complex chronic care management.

      Many commenters recommended that CMS adopt the three CPT codes describing chronic care management. In addition to the CPT code that is similar to the G-code described above (CPT code 99490), there are two additional complex chronic care coordination codes (a base code and an add-on code). Since CY 2013 when the complex chronic care coordination codes became available, CMS has bundled these codes. The base code is CPT code 99487 (Cmplx chron care w/o pt visit), and the add-on is CPT code 99489 (Complex chronic care coordination services; each additional 30 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month (list separately in addition to code for primary procedure).

      Other commenters recommended using two codes to describe CCM for different patient populations, or a base code and an add-on code to describe CCM for a single patient population. Some commenters recommended adoption of GXXX1 or CPT code 99490, plus CPT code 99487 along with the RUC-recommended values, to describe CCM for the two distinct populations that require different services. These commenters stated that there is no ``typical'' patient that characterizes both groups of patients, and that a large number of eligible beneficiaries (those having 2 or more chronic conditions) have serious mental health and/or substance abuse disorders and would benefit greatly from CCM services). Other commenters recommended using two G-codes, one being an add-on code for each additional 20 minutes or other time spent caring for a beneficiary with more complex needs. One commenter urged CMS to adopt an add-on code for time increments over 60 minutes. Several commenters recommended a cap on additional minutes, particularly if CMS finalizes an applicable beneficiary coinsurance for CCM services. One commenter recommended that we finalize the proposed valuation for GXXX1, also recognize CPT code 99490 (Chron care mgmt srvc 20 min) with a higher payment amount, and then collect data on the impacts of differential payment amounts.

      Other commenters recommended that CMS adopt CPT code 99487 (Cmplx chron care w/o pt visit) with the scope of services for GXXX1. One commenter recommended that CMS redefine its requirements and the scope of services for GXXX1 to be more consistent with chronic disease management, using CPT code 99487. The commenter believed we should adopt CPT code 99487 with the RUC-recommended valuation. One commenter more generally

      Page 67719

      recommended that CMS adopt a higher intensity code for patients requiring 45-60 minutes or more of clinical staff time for assessment, medication management, care planning, coordination, education and advocacy.

      Response: At this time, we believe that Medicare beneficiaries with two or more chronic conditions as defined under the CCM code can benefit from care management and want to make this service available to all such beneficiaries. Like all services, we recognize that some beneficiaries will need more services and some less, and thus we pay based upon the typical service. However all scope of service elements apply for delivery of CCM services to any eligible Medicare beneficiary. We will evaluate the utilization of this service to evaluate what types of beneficiaries receive the service described by this CPT code, what types of practitioners are reporting it, and consider any changes in payment that may be warranted in the coming years. We are maintaining the status indicator ``B'' (Bundled) for CY 2015 for the complex care coordination codes, CPT codes 99487 and 99489.

      Comment: Several commenters requested that CMS create codes specific to remote patient biometric monitoring (recording vital signs and other physiological data and transmitting real-time data to physicians). Several commenters requested codes specific to or inclusive of certain hematology, nephrology, endocrine and allergy/

      immunology conditions, such as chronic kidney disease, end-stage renal disease, diabetes and severe asthma. One commenter recommended that CMS delay implementation of this service for CY 2015 and propose for CY 2016 specific complex chronic care codes for each of the major chronic diseases, especially diabetes.

      Response: We are not convinced that the care management services are sufficiently unique based upon the beneficiary's specific chronic conditions to warrant separate codes, especially given the beneficiary must have at least two chronic conditions. As noted above, we will be monitoring this service and will consider making changes if they appear warranted.

      After consideration of the comments received on this proposal, we are finalizing the proposal with the following modification. Rather than creating a G-code we are adopting the new CPT code, 99490, to describe CCM services effective January 1, 2015. We intend to evaluate this service closely to assess whether the service is targeted to the right population and whether the payment is appropriate for the services being furnished. As part of our evaluation, we will consider the whether this new service meets the care coordination needs of Medicare beneficiaries and if not how best to address the unmet needs.

      2. CCM and TCM Services Furnished Incident to a Physician's Service Under General Physician Supervision

      In the CY 2014 PFS final rule with comment period (78 FR 74425 through 74427), we discussed how the policies relating to services furnished incident to a practitioner's professional services apply to CCM services. (In this discussion, the term practitioner means both physicians and NPPs who are permitted to bill for services furnished incident to their own professional services.) Specifically, we addressed the policy for counting clinical staff time for services furnished incident to the billing practitioner's services toward the minimum amount of service time required to bill for CCM services.

      We established an exception to the usual rules that apply to services furnished incident to the services of a billing practitioner. Generally, under the ``incident to'' rules, practitioners may bill for services furnished incident to their own services if the services meet the requirements specified in our regulations at Sec. 410.26. One of these requirements is that the ``incident to'' services must be furnished under direct supervision, which means that the supervising practitioner must be present in the office suite and be immediately available to provide assistance and direction throughout the service (but does not mean that the supervising practitioner must be present in the room where the service is furnished). We noted in last year's PFS final rule with comment period that, because one of the required elements of the CCM service is beneficiary access to the practice 24-

      hours-a-day, 7-days-a-week, to address the beneficiary's chronic care needs (78 FR 74426), we expect the beneficiary to be provided with a means to make timely contact with health care providers in the practice whenever necessary to address chronic care needs regardless of the time of day or day of the week. In those cases when the need for contact arises outside normal business hours, it is likely that the beneficiary's initial contact would be with clinical staff employed by the practice (for example, a nurse) and not necessarily with a practitioner. Under these circumstances, it would be unlikely that a practitioner would be available to provide direct supervision of the service.

      Therefore, in the CY 2014 PFS final rule with comment period, we created an exception to the generally applicable requirement that ``incident to'' services must be furnished under direct supervision. Specifically, we finalized a policy to require only general, rather than direct, supervision when CCM services are furnished incident to a practitioner's services outside of the practice's normal business hours by clinical staff who are direct employees of the practitioner or practice. We explained that, given the potential risk to beneficiaries that the exception to direct supervision could create, we believed that it was appropriate to design the exception as narrowly as possible (78 FR 74426). The direct employment requirement was intended to balance the less stringent general supervision requirement by ensuring that there is a direct oversight relationship between the supervising practitioner and the clinical staff personnel who provide after-hours services.

      In the CY 2015 PFS proposed rule, we proposed to revise the policy that we adopted in the CY 2014 PFS final rule with comment period. We also proposed to amend our regulations to codify the requirements for CCM and TCM services furnished incident to a practitioner's services. Specifically, we proposed to remove the requirement that, in order to count the time spent by clinical staff providing aspects of CCM services toward the CCM time requirement, the clinical staff person must be a direct employee of the practitioner or the practitioner's practice. (We note that the existing requirement that these services be provided by clinical staff, specifically, rather than by other auxiliary personnel is an element of the service for both CCM and TCM services, rather than a requirement imposed by the ``incident to'' rules themselves.) We also proposed to remove the restriction that services provided by clinical staff under general (rather than direct) supervision may be counted only if they are provided outside of the practice's normal business hours. Under our proposed revised policy, then, the time spent by clinical staff providing aspects of CCM services can be counted toward the CCM time requirement at any time, provided that the clinical staff are under the general supervision of a practitioner and all other requirements of the ``incident to'' regulations at Sec. 410.26 are met.

      We proposed to revise these aspects of the policy for several reasons. First, one of the required elements of the CCM service is the availability of a means for the beneficiary to make contact with

      Page 67720

      health care practitioners in the practice to address a beneficiary's urgent chronic care needs (78 FR 74418 through 74419). Other elements within the scope of CCM services are similarly required to be furnished by practitioners or clinical staff. We believe that these elements of the CCM scope of service require the presence of an organizational infrastructure sufficient to adequately support CCM services, irrespective of the nature of the employment or contractual relationship between the clinical staff and the practitioner or practice. We also believe that the elements of the CCM scope of service, such as the requirement of a care plan, ensure a close relationship between a practitioner furnishing ongoing care for a beneficiary and clinical staff providing aspects of CCM services under general supervision; and that this close working relationship is sufficient to render a requirement of a direct employment relationship or direct supervision unnecessary. Under our proposal, CCM services could be furnished ``incident to'' if the services are provided by clinical staff under general supervision of a practitioner whether or not they are direct employees of the practitioner or practice that is billing for the service; but the clinical staff must meet the other requirements for auxiliary personnel including those at Sec. 410.26(a)(1). Other than the exception to permit general supervision for clinical staff, the same requirements apply to CCM services furnished incident to a practitioner's professional services as apply to other ``incident to'' services. Furthermore, since last year's final rule, we have had many consultations with physicians and others about the organizational structures and other factors that contribute to effective provision of CCM services. These consultations have convinced us that, for purposes of clinical staff providing aspects of CCM services, it does not matter whether the practitioner is directly available to supervise because the nature of the services are such that they can be, and frequently are, provided outside of normal business hours or while the physician is away from the office during normal business hours. This is because, unlike most other services to which the ``incident to'' rules apply, the CCM services are intrinsically non-face-to-face care coordination services.

      In conjunction with this proposed revision to the requirements for CCM services provided by clinical staff incident to the services of a practitioner, we also proposed to adopt the same requirements for equivalent purposes in relation to TCM services. As in the case of CCM, TCM explicitly includes separate payment for services that are not necessarily furnished face-to-face, such as coordination with other providers and follow-up with beneficiaries. It would also not be uncommon for auxiliary personnel to provide elements of the TCM services when the physician was not in the office. Generally, we believe that it is appropriate to treat separately billable care coordination services similarly whether in the form of CCM or TCM. We also believe that it would be appropriate to apply the same ``incident to'' rules that we are proposing for CCM services to TCM services. We did not propose to extend this policy to the required face-to-face portion of TCM. Rather, the required face-to-face portion of the service must still be furnished under direct supervision.

      Therefore, we proposed to revise our regulation at Sec. 410.26, which sets out the applicable requirements for ``incident to'' services, to permit TCM and CCM services provided by clinical staff incident to the services of a practitioner to be furnished under the general supervision of a physician or other practitioner. As with other ``incident to'' services, 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. We note that all other ``incident to'' requirements continue to apply and that the usual documentation of services provided must be included in the medical record.

      Commenters uniformly supported our proposal to revise our regulation at Sec. 410.26, which sets out the applicable requirements for ``incident to'' services, to permit TCM and CCM services provided by clinical staff incident to the services of a practitioner to be furnished under the general supervision of a physician or other practitioner. Under the revised regulation, then, the time spent by clinical staff providing aspects of TCM and CCM services can be counted toward the TCM or CCM time requirement at any time, provided that the clinical staff are under the general supervision of a practitioner and all requirements of the revised ``incident to'' regulations at Sec. 410.26 are met.

      Comment: One commenter requested guidance concerning whether (as has been the case with E/M codes) activities billed under ``incident to'' will not be able to also be billed under the CCM code.

      Response: The purpose of our proposal was to allow elements of CCM services that are furnished by clinical staff incident to a practitioner's professional services (under the ``incident to'' regulations) to be included and reported as CCM services. We are not entirely clear what the commenter is asking, but the time spent furnishing CCM services can only be counted once and for only one purpose, and each discrete service can be billed only once. Although we and our contractors provide many educational materials, practitioners who furnish Medicare covered items and services are responsible for learning how to appropriately bill each service.

      Comment: One commenter urged us to revise the terminology by which we define the CCM and TCM services to reflect non-hierarchical interdisciplinary team care, rather than relying on an incident-to structure that obscures the actual provider of direct patient care. This commenter expressed concern about loss of benefits to clinicians under contract with a practice, rather than being employed by the practice. Another commenter similarly expressed concern that the expanded authorization for ``general supervision'' rather than ``direct supervision'' would provide an even greater incentive for physicians to require that any E/M service provided by an Advanced Practice Registered Nurse (APRN) in their practice be billed as ``incident to'' a physician's service. This could reduce transparency in billing data and diminish accountability for services for Part B beneficiaries.

      Response: We do not entirely understand the basis for these concerns. We have accommodated numerous requests to include contracted employees within the scope of the ``incident to'' rules for purposes of counting time toward the TCM and CCM requirements. We have not otherwise proposed to revise the ``incident to'' and other regulations within which practitioners operate as they make decisions about whether to contract or directly employ clinical staff, or about how to bill for services provided. Although they are important within the context of the new TCM and CCM services, we believe that the revisions to our ``incident to'' regulation that are adopted in this final rule, are peripheral in the context of the overall employment and billing practices of physicians and group practices.

      After consideration of the comments, we are finalizing our proposal to revise our regulation at Sec. 410.26, which sets out the applicable requirements for ``incident to'' services, to permit the CCM and non-

      face-to-face portion of the TCM services provided by clinical staff incident to the services of a practitioner

      Page 67721

      to be furnished under the general supervision of a physician or other practitioner.

      3. Scope of Services and Standards for CCM Services

      In the CY 2014 final rule with comment period (78 FR 74414 through 74428), we defined the elements of the scope of service for CCM that are required for a practitioner to bill Medicare for the CCM service. In addition, we indicated that we intended to develop standards for practices that furnish CCM services to ensure that the practitioners who bill for these services have the capability to fully furnish them (78 FR 74415, 74418). At that time, we anticipated that we would propose these standards in the CY 2015 PFS proposed rule. We actively sought input toward development of these standards by soliciting public comments on the CY 2014 PFS final rule with comment period, through outreach to stakeholders in meetings, by convening a Technical Expert Panel, and by collaborating with federal partners such as the Office of the Assistant Secretary for Planning and Evaluation, the Office of the Assistant Secretary for Health, the Office of the National Coordinator for Health Information Technology (ONC), and the Health Resources and Services Administration. Our goal is to recognize the trend toward practice transformation and overall improved quality of care, while preventing unwanted and unnecessary care.

      As we worked to develop appropriate practice standards that would meet this goal, we consistently found that many of the standards we thought were important overlapped in significant ways with the scope of service or with the billing requirements for the CCM services that had been finalized in the CY 2014 final rule with comment period. In cases where the standards we identified were not unique to CCM requirements, we found that the standards overlapped with other Medicare requirements or other federal requirements that apply generally to health care practitioners. Based upon the feedback we received, we sought to avoid duplicating other requirements or, worse, imposing conflicting requirements on practitioners that would furnish CCM services. Given the standards and requirements that are already in place for health care practitioners and applicable to those who furnish and bill for CCM services, we decided not to propose an additional set of standards that would have to be met in order for practitioners to furnish and bill for CCM services. Instead of proposing a new set of standards applicable to only CCM services, we decided to emphasize that certain requirements are inherent in the elements of the existing scope of service for CCM services, and clarify that these must be met in order to bill for CCM services. The CCM scope of service elements finalized in the CY 2014 PFS final rule (78 FR 74414 through 74428) are as follows.

      The provision of 24-hour-a-day, 7-day-a-week access to address the patient's acute chronic care needs. To accomplish this, the patient must be provided with a means to make timely contact with health care providers in the practice to address the patient's urgent chronic care needs regardless of the time of day or day of the week.

      Continuity of care with a designated practitioner or member of the care team with whom the patient is able to get successive routine appointments.

      Care management for chronic conditions including systematic assessment of the 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.

      In consultation with the patient, any caregiver and other key practitioners treating the patient, the practitioner furnishing CCM services must create a patient-centered care plan document to assure that care is provided in a way that is congruent with patient choices and values. The care plan is based on a physical, mental, cognitive, psychosocial, functional and environmental (re)assessment and an inventory of resources and supports. It is a comprehensive plan of care for all health issues, and typically includes, but is not 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 billing practice will be directed/coordinated, identify the individuals responsible for each intervention, requirements for periodic review and, when applicable, revision of the care plan. A full list of problems, medications and medication allergies in the EHR must inform the care plan, care coordination and ongoing clinical care.

      Management of care transitions within health care, including referrals to other clinicians, follow-up after the patient's visit to an emergency department, and follow-up after discharges from hospitals, skilled nursing facilities, or other health care facilities. The practice must facilitate communication of relevant patient information through electronic exchange of a summary care record with other health care providers regarding these transitions. The practice must also have qualified personnel who are available to deliver transitional care services to the patient in a timely way so as to reduce the need for repeat visits to emergency departments and readmissions to hospitals, skilled nursing facilities or other health care facilities.

      Coordination with home and community based clinical service providers required to support the patient's psychosocial needs and functional deficits. Communication to and from home and community based providers regarding these patient needs must be documented in the patient's medical record.

      Enhanced opportunities for the beneficiary and any relevant caregiver to communicate with the practitioner 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.

      Similarly, we reminded stakeholders of the following additional billing requirements established in the CY 2014 final rule with comment period (in the following list, we have changed the service period from the 2015 proposed 30-day period to the final 2015 service period of one calendar month):

      Inform the beneficiary about the availability of the CCM services from the practitioner and obtain his or her written agreement to have the services provided, including the beneficiary's authorization for the electronic communication of the patient's medical information with other treating providers as part of care coordination.

      Document in the beneficiary's medical record that all elements of the CCM service were explained and offered to the beneficiary, and note the beneficiary's decision to accept or decline the service.

      Provide the beneficiary a written or electronic copy of the care plan and document in the electronic medical record that the care plan was provided to the beneficiary.

      Inform the beneficiary of the right to stop the CCM services at any time (effective at the end of a calendar month) and the effect of a revocation of the agreement to receive CCM services.

      Inform the beneficiary that only one practitioner can furnish and be paid for

      Page 67722

      these services during the calendar month service period.

      In one area, electronic health records (EHRs), we were concerned that the existing elements of the CCM service could leave some gaps in assuring that beneficiaries consistently receive care management services that offer the benefits of advanced primary care as it was envisioned when this service was created. It is clear that effective care management can be accomplished only through regular monitoring of the patient's health status, needs, and services, and through frequent communication and exchange of information with the patient and among the various health care practitioners and providers treating the patient. After gathering input from stakeholders through the CY 2014 rulemaking cycle, for 2015 we proposed a new scope of service element that would require use of a certified EHR and electronic care planning to furnish CCM services. We believed that requiring those who furnish CCM services to utilize EHR technology that has been certified by a certifying body authorized by the National Coordinator for Health Information Technology was necessary to ensure that key patient information is stored, shared and reconciled among the many practitioners and providers involved in managing the patient's chronic conditions, otherwise care could not be coordinated and managed. Requiring a certified EHR would enable members of the interdisciplinary care team to have immediate access to the most updated information informing the care plan. Therefore we proposed that the billing practitioner must utilize EHR technology certified by a certifying body authorized by the National Coordinator for Health Information Technology to an edition of the EHR certification criteria identified in the then-applicable version of 45 CFR part 170. We proposed that at a minimum, the practice must utilize EHR technology that meets the certification criteria adopted at 45 CFR 170.314(a)(3), 170.314(a)(4), 170.314(a)(5), 170.314(a)(6), 170.314(a)(7) and 170.314(e)(2) pertaining to the capture of demographics, problem lists, medications, and other key elements related to the ultimate creation of an electronic summary care record. These sections of the regulation comprise the certification criteria for specific core technology capabilities (structured recording of demographics, problems, medications, medication allergies, and the creation of a structured clinical summary) for the 2014 edition. Under the proposal, practitioners furnishing CCM services beginning in CY 2015 would be required to utilize an EHR certified to at least these 2014 edition certification criteria. Given these 2014 edition criteria, the EHR technology would be certified to capture data and ultimately produce summary records according to the HL7 Consolidated Clinical Document Architecture standard (see 45 CFR 170.205(a)(3)).

      In addition, when any of the CCM scope of service elements refers to a health or medical record, we proposed to require use of an EHR certified to at least the 2014 edition certification criteria to fulfill the scope of service element in relation to the health or medical record. As finalized in the CY 2014 PFS final rule, the scope of service elements that reference a health or medical record are:

      A full list of problems, medications and medication allergies in the EHR must inform the care plan, care coordination and ongoing clinical care.

      Communication to and from home and community based providers regarding the patient's psychosocial needs and functional deficits must be documented in the patient's medical record.

      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.

      Provide the beneficiary a written or electronic copy of the care plan and document in the electronic medical record that the care plan was provided to the beneficiary.

      Regarding the care plan in particular, we believed that requiring practitioners furnishing CCM services to maintain and share an electronic care plan would alleviate the errors that can occur when care plans are not systematically reconciled. To ensure that practices offering CCM services meet these needs, we proposed that CCM services must be furnished with the use of an EHR or other health IT or health information exchange platform that includes an electronic care plan that is accessible to all practitioners within the practice, including being accessible to those who are furnishing care outside of normal business hours, and that is available to be shared electronically with care team members outside of the practice. This was a more limited proposal compared to our CY 2014 proposal that we did not finalize that would have required members of the chronic care team who are involved in the after-hours care of the patient to have access to the beneficiary's full electronic medical record (78 FR 74416 through 74417).

      Regarding the clinical summary, we proposed to require technology certified to the 2014 edition for the electronic creation of the clinical summary, formatted according to the standard adopted at 45 CFR 170.205(a)(3), but we did not specify that this format must be used for the exchange of beneficiary information (79 FR 40367). For instance, we did not propose that practitioners billing for CCM services must adopt certified technology related to the exchange of a summary care record such as the transmission standard related to Direct Project Transport in 45 CFR 170.314(b)(2)(ii).

      We indicated that we believed our proposed new scope of service element for a certified EHR and electronic care planning would ensure that practitioners billing for CCM could fully furnish the services, allow practitioners to innovate around the systems that they use to furnish these services, and avoid overburdening small practices. We indicated that we believed that allowing flexibility as to how practitioners capture, update, and share care plan information was important at this stage given the maturity of current EHR standards and other electronic tools in use in the market today for care planning.

      In addition to seeking comment on this new proposed scope of service element, we sought comment on any changes to the scope of service or billing requirements for CCM services that may be necessary to ensure that the practitioners who bill for these services have the capability to furnish them and that we can appropriately monitor billing for these services. With the addition of the electronic health information technology element that we proposed, we believed that the elements of the scope of service for CCM services, when combined with other important federal health and safety regulations, would provide sufficient assurance that practitioners billing for CCM could fully furnish the services, and that Medicare beneficiaries receiving CCM would receive appropriate services. However we expressed special interest in receiving public feedback regarding any meaningful elements of the CCM service or beneficiary protections that may be missing from the scope of service elements and billing requirements.

      The following paragraphs summarize the comments we received regarding

      Page 67723

      these elements of the scope of service for CCM services and our responses.

      Comment: Some commenters were disappointed that CMS did not propose an additional set of standards. The commenters expressed concern that there would not be sufficient accountability for high quality CCM services. Some commenters recommended further development of standards such as inclusion of evidence-based self-management programs offered by community organizations, quality measures that engage patients and demonstrate improved outcomes, or a best practices guide to assist the physician community with implementation. However, many commenters opposed further standards, and agreed with CMS that additional standards would largely overlap with other Medicare requirements or were already reflected in the scope of service elements.

      Response: We appreciate the commenters' concerns about ensuring quality of care. We continue to believe that with the addition of the EHR element, the required scope of service elements are sufficient for ensuring high quality CCM services in 2015. We note that section III.K of this final rule with comment period addresses quality measures for physicians' services, and stakeholders may submit suggestions for quality measures related to CCM in response to this section of the regulation.

      Comment: Many commenters expressed broad support for our EHR proposal. The commenters commended the strong emphasis on data sharing and requirements for a robust EHR as vital to successful care coordination and continuity of care. Several commenters did not believe the proposal would pose a significant administrative burden. One commenter noted that use of an EHR would help practitioners to document the time spent furnishing CCM services.

      Although commenters supported adoption of certified EHR technology (CEHRT) generally, many were concerned that an insufficient number of physicians have adopted CEHRT with the functionalities we proposed for CCM, especially interoperability with other providers. The commenters were also concerned that physicians practicing in rural or economically depressed areas would not have the resources to implement such technology and would be disqualified from furnishing separately billable CCM services. Many believed the proposal was laudable but premature, recommending that CMS delay adoption of the 2014 EHR certification criteria for CCM services by 3 to 4 years when they will be more widely adopted, or phase in the 2014 certification criteria over 2 years as a requirement for 2017. Several commenters recommended that we finalize our proposal but provide hardship exceptions for certain smaller or rural practices to enable them to bill separately for CCM services in the absence of an interoperable EHR in certain circumstances, provide financial incentives, or allow other flexibility around the requirements for physicians who cannot meet them at this time. One commenter supported the proposal but suggested we allow aspects of CCM services to be furnished using fax and secure messaging technology if physicians encounter challenges with interoperability. Until EHR systems are interoperable, some commenters suggested allowing practitioners to attest that all requirements for billing CCM were met using CEHRT or an alternative technology, or to attest that all members of the care team have timely access (24/7 access in ``real time'' or ``near real time'') to the most updated information regarding the care plan through either electronic or non-electronic means, with ongoing efforts to implement interoperable EHRs. The commenters stated many practices are making patient information accessible in a timely manner to the entire care team, but have not yet fully implemented an interoperable EHR with other providers. Several commenters were concerned about the ability of current EHR technologies to share information across different providers and EHR systems. Commenters requested that CMS ensure that no certified EHR contains technological or business impediments to data sharing across disparate technology platforms used by multiple providers trying to coordinate care. In addition, many commenters were concerned about access to CCM services, and recommended that CMS prioritize access over adoption of CEHRT. Several commenters stated that not all types of physicians have access to an EHR that meets the needs of their specialty.

      A number of commenters stated that CCM could be (and already is) effectively provided without any EHR or a without a certified EHR, and recommended that CMS rescind the proposal or make the EHR requirement optional. These commenters disagreed with the requirement that CCM services must be furnished with use of a certified EHR, information technology (IT) platform or exchange platform that includes a care plan, with some stating that certified EHR systems have not demonstrated improvements in the management of chronic conditions, especially complex cases, and suggested postponing the care plan and other EHR requirements until they are proven effective and adopted by most providers. Others stated that an EHR was necessary and that CMS should require an EHR that promotes communication among various professional on the care team, includes the patient as part of the team, and enables clinical monitoring and effective care planning. Commenters indicated that many physicians accomplish this through generating or receiving electronic discharge summaries, clinical documentation, and patient-centered plans of care, but are not using certified technologies to carry out these functions and should not be penalized.

      One commenter stated that only about half of all physicians had an EHR system with advanced functionalities in 2013, many current systems were not designed with interoperability in mind and transition costs are high. The commenter believed the proposed payment amount would not sufficiently cover the cost of purchasing or upgrading an EHR system, and requiring a certified EHR would limit the number of eligible physicians without significantly adding value to CCM services. Another commenter stated that only 1,000 physicians and other eligible health professionals have achieved Stage 2 of Meaningful Use of certified EHR technology, compared with more than 300,000 physicians and eligible professionals who have achieved Stage 1.

      Response: We continue to believe that it is necessary to require the use of EHR technology that has been certified under the ONC Health IT Certification Program as requisite for receiving separate payment for CCM services, to ensure that practitioners have adequate capabilities to allow members of the interdisciplinary care team to have timely access to the most updated information informing the care plan. We agree with commenters that health IT tools are most effective when there are no technological or business impediments to data sharing, or disparate technology platforms used by multiple providers trying to coordinate care, and that we should ensure common functionalities as much as possible across providers. However, we also agree with commenters who expressed concern that requiring the most recent edition of EHR certification criteria could be an impediment to the broad utilization of the CCM service. In response to comments, we are modifying our proposal regarding which

      Page 67724

      edition of certified EHR technology will be required, in order to allow more flexibility as practitioners transition to the use of certified EHR technology. Accordingly, we are modifying our proposal to specify that the CCM service must be furnished using, at a minimum, the edition(s) of certification criteria that is acceptable for purposes of the EHR Incentive Programs as of December 31st of the calendar year preceding each PFS payment year (hereinafter ``CCM certified technology'') to meet the final core technology capabilities (structured recording of demographics, problems, medications, medication allergies, and the creation of a structured clinical summary). Practitioners must also use this CCM certified technology to fulfill the CCM scope of service requirements whenever the requirements reference a health or medical record. This will ensure that requirements for CCM billing under the PFS are consistent throughout each PFS payment year and are automatically updated annually according to the certification criteria required for the EHR Incentive Programs. For CCM payment in CY 2015, this policy will allow practitioners to use EHR technology certified to either the 2011 or 2014 edition(s) of certification criteria to meet the final core capabilities for CCM and to fulfill the CCM scope of service requirements whenever the requirements reference a health or medical record. We are finalizing the separate provision we proposed for the electronic care plan scope of service element without modification as discussed below. We remind stakeholders that for all electronic sharing of beneficiary information under our final CCM policies, HIPAA standards apply in the usual manner.

      Comment: Several commenters questioned the relationship between the Meaningful Use criteria and the proposed EHR scope of service element for CCM. One commenter stated that none of the requirements for EHR capability for payment of CCM services should be tied to or related to Meaningful Use, because many of the Meaningful Use requirements do not apply to CCM. Another commenter supported what they understood to be our proposal, to require billing physicians to adopt an EHR and utilize it to meet the most recent standard for Meaningful Use. However, the commenter noted (similar to the previous commenter) that the current functionalities and standards for EHR technology required for Meaningful Use are not entirely aligned with the functionalities required for CCM, for example the commenter believed that the electronic care plan need only be shared 10 percent of the time to meet Meaningful Use measures, but that CCM would require it to be available 24/7 and to all practitioners. The commenter expressed concern that practitioners might not be able to furnish CCM as envisioned by CMS due to discrepancies with the Meaningful Use criteria, and urged CMS to adopt interoperability standards for Meaningful Use that would enable successful care coordination models. Another commenter recommended that enforcement of the proposed EHR requirement be coterminous with the enforcement of Meaningful Use Stage 2 to ensure practices have the ability to comply.

      Response: Although we understand why some commenters would like for the requirements for the EHR Incentive Programs and the EHR scope of service element for CCM to be identical, we do not believe that is entirely possible because of the different nature and purpose of the respective EHR specifications. In many respects they are not comparable requirements. For example, the PFS sets payment requirements prospectively for a given calendar year, while the EHR Incentive Program may change requirements mid-year. In addition, many of the Meaningful Use measures are not relevant for the provision of CCM and we believe we should only require practitioners to adopt the certified technology that is relevant to the scope of CCM services. In their attempts to meet Meaningful Use criteria for a given year, practitioners are required to use technology certified to a specific edition(s) of certification criteria to meet the CEHRT definition, and as we discussed above we are aligning the edition required to bill CCM with the edition(s) required for Meaningful Use each year. However, it is conceivable that a practitioner could use CCM certified technology to provide and be paid for CCM in a given calendar year that will not be sufficient for achieving Meaningful Use in that same year because CCM must be furnished using at least the edition(s) of certified EHR technology required for the EHR Incentive Programs as of December 31st of the prior calendar year. Also, it is possible that a practitioner could use technology certified to an edition that qualifies for CCM payment that could also be used to achieve Meaningful Use for a given calendar year, but still not meet the objectives and associated measures of a particular stage of Meaningful Use that are required to qualify for an EHR Incentive payment or avoid a downward adjustment to payments. As the commenters noted, the Meaningful Use measures are not all relevant to the provision of CCM services, and the practitioner may not have sufficient certified technology to support all the necessary or relevant Meaningful Use objectives and measures under the EHR Incentive Programs. Certified technology is used in different ways to meet the requirements of each program. We believe that the policy we are finalizing here aligns the CCM scope of service element to the extent appropriate with the EHR Incentive Programs to achieve maximum consistency.

      Comment: Several commenters asked us to clarify the requirement for the electronic care plan in relationship to the overall requirement for a certified EHR and in relationship to the 24/7 access requirement. The commenters stated they were not sure whether these proposals were independent provisions or impacted one another. The commenters stated that if CMS intended these as independent provisions, the agency should identify objective criteria to evaluate whether a particular health IT product has adequate capabilities to meet the separate requirement for the electronic care plan. The commenters stated they were not sure whether the electronic care plan would require a certified EHR, or whether there would be an exception to use of CEHRT for the care plan. The commenters recommended flexibility in how practitioners and providers capture, develop, update and share care plan information. One commenter recommended that if practitioners must attest to use of a qualifying electronic care plan, CMS should only require a simple yes/

      no response to minimize billing impediments. One commenter asked us to clarify the required elements of the care plan in relation to different EHR systems.

      In addition, several commenters requested that we clarify whether the care plan must be electronically accessible 24/7 to all providers treating the patient's chronic conditions, those within the billing practice, or those within the billing practice who are communicating with the patient after hours. The commenters noted that providers other than the billing practitioner may not use the same certified EHR, so it would be unreasonable to expect the same care plan and other relevant information to be accessible to all providers at all times. Other commenters believed we proposed flexibility around the certified EHR requirement in relation to the

      Page 67725

      electronic care plan, and supported this proposed flexibility.

      Response: Regarding the care plan, we proposed that CCM services must be furnished with the use of an EHR or other health IT or health information exchange platform (not necessarily a certified EHR) that includes an electronic care plan that is accessible at all times to the practitioners within the practice, including those who are furnishing CCM outside of normal business hours. By practitioners ``within the practice,'' we mean any practitioners furnishing CCM services whose minutes count towards a given practice's time requirement for reporting the CCM billing code.

      In addition, we proposed that the electronic care plan must be available to be shared electronically with care team members outside the practice (who are not billing for CCM). We sought to convey that practitioners could satisfy these requirements related to the care plan without using the certified EHR technology. We specified that the certified EHR technology is only required to accomplish activities described in the scope of service elements that specifically mention a medical record or EHR. We said that a full list of problems, medications and medication allergies in the certified EHR (which would follow structured recording formats) must inform the care plan, not that the care plan itself must be created or transmitted among providers using certified EHR technology. We note that this was a limited proposal compared to our CY 2014 proposal that we did not finalize that would have required members of the chronic care team who are involved in the after-hours care of the patient to have access to the patient's full electronic medical record instead of just the care plan (78 FR 74416 through 74417).

      Through separate requirements for the electronic care plan and the certified EHR, our intent was to require practitioners to use some form of electronic technology tool or service in fulfilling the care plan element (other than facsimile transmission), recognizing that certified EHR technology is limited in its ability to support electronic care planning at this time, and that practitioners must have flexibility to use a wide range of tools and services beyond certified EHR technology now available in the market to support electronic care planning. We intended that all care team members furnishing CCM services that are billed by a given practice (contributing to the minimum time required for billing) must have access to the electronic care plan at all times when furnishing CCM services. However, the electronic care plan would not have to be available at all times to other non-billing practices, recognizing that other practices may not be using compatible electronic technology or participating in a health information exchange.

      We are finalizing the electronic care plan and 24/7 access elements as proposed, clarifying that to satisfy the care plan scope of service element, practitioners must electronically capture care plan information and make this information available to all care team members furnishing CCM services that are billed by a given practice (counting towards the minimum monthly service time), even when furnishing CCM outside of normal business hours. In addition, practitioners must electronically share care plan information as appropriate with other providers and practitioners who are furnishing care to the patient. We are not requiring that practitioners use a specific electronic technology to meet the requirement for 24/7 access to the care plan or its transmission, only that they use an electronic technology other than facsimile. For instance, practices may satisfy the 24/7 care plan access requirement through remote access to an EHR, web-based access to a care management application, or web-based access to a health information exchange service that captures and maintains care plan information. Likewise, we are not requiring that practitioners use a specific electronic technology to meet the requirement to share care plan information electronically with other practitioners and providers who are not billing for CCM. For instance, practitioners may meet this sharing requirement through the use of secure messaging or participation in a health information exchange with those practitioners and providers, although they may not use facsimile transmission.

      While we are not requiring that practitioners use a specific electronic technology at this time (other than not allowing facsimile), we may revisit this requirement as standards-based exchange of care plan information becomes more widely available in the future. We remind stakeholders that for all electronic sharing of beneficiary information under our final CCM policies, HIPAA standards apply in the usual manner.

      Comment: Several commenters asked us to clarify the relationship between the certified EHR proposal and the summary record exchange requirement. Commenters believed that CMS had cited specific regulatory provisions around exchange in the proposed rule (identified by the commenter as a Summary Record Exchange (SRE) capability tag, referring to a designation used to identify those products on the Certified Health IT Product List maintained by ONC offering technology certified to criteria around the exchange of summary care records) and should consider alternatives. The commenters were not clear as to whether they objected to what they believed to be the proposed format or the transmission method of the summary record exchange.

      Response: In the CY 2014 PFS final rule with comment period, as part of the care transitions management scope of service element, we indicated that the practice must be able to facilitate the communication of relevant patient information through electronic exchange of a summary care record with other health care providers (78 FR 74418). We did not specify a standard for the ``summary care record'' that providers must exchange electronically, nor did we specify a method by which providers must facilitate the communication of beneficiary information, such as use of certified EHR technology. In the CY 2015 PFS proposed rule (79 FR 40367), we proposed that the practitioner must utilize EHR technology certified by a certifying body authorized by the National Coordinator for Health Information Technology to an edition of the EHR certification criteria identified in the then-applicable version of 45 CFR part 170. Under one of the specific certification criteria cited, we proposed that practitioners must use technology that meets the criterion adopted at Sec. 170.314(e)(2), which would ensure that they produce summary records formatted according to the standard adopted at Sec. 170.205(a)(3). However, we did not propose that this formatting standard must be used for the exchange of patient information, only that in furnishing CCM services, practitioners must format their summaries according to this standard. We did not propose that providers billing for CCM services must adopt any certified technology for the exchange of a summary care record, such as the transmission standard related to Direct Project Transport in Sec. 170.314(b)(2)(ii). We recognized that providers are currently exchanging patient information to support transitions of care in a variety of meaningful ways beyond the methods specified with 2014 edition certified technology, with the exception of faxing which would not meet the proposed scope of service requirement. The 2014

      Page 67726

      edition sets specific requirements for transmission or exchange of the summary record that technology must meet for certification, and we expected that only some practitioners could adopt and use such technology in CY 2015. Therefore we did not constrain practitioners to the exchange functionality in the 2014 edition if they utilized an alternative electronic tool.

      As discussed above, our final policy will allow practitioners billing the PFS for CCM services to use the edition(s) of certification criteria that is acceptable for the EHR Incentive Programs as of December 31st of each calendar year preceding each PFS payment year to meet the final core technology capabilities (structured recording of demographics, problems, medications, medication allergies, and the creation of a structured clinical summary). (Also practitioners must use this CCM certified technology to fulfill the CCM scope of service requirements whenever the requirements reference a health or medical record). Under this final policy, practitioners must format their structured clinical summaries according to, at a minimum, the standard that is acceptable for the EHR Incentive Programs as of December 31st of the calendar year preceding each PFS payment year.

      We are finalizing our proposal that practitioners must communicate relevant patient information through electronic exchange of a summary care record to support transitions of care, with a clarification that practitioners do not have to use any specific content exchange standard in CY 2015. We did not propose and are not finalizing a requirement to use a specific tool or service to communicate beneficiary information, as long as providers do so electronically. We note however that faxing will not fulfill this requirement for exchange of the summary care record. We did not propose to modify our view, discussed in the CY 2014 PFS final rule with comment period, that practitioners furnishing and billing for CCM services must be able to support care transitions through the electronic exchange of beneficiary information in a summary care record (78 FR 74418). While certain 2014 edition certification criteria address a content standard and transmission method for exchange of a summary record, we continue to expect that only some practitioners could adopt and use such technology. Moreover, we recognize that providers are currently exchanging patient information to support transitions of care in a variety of meaningful ways beyond the methods specified in 2014 edition certification criteria. We continue to believe that at least for CY 2015, we should allow flexibility in the selection of the electronic tool or service that is used to transmit beneficiary information in support of care transitions, as long as practitioners electronically share beneficiary information to support transitions of care. Finally we remind stakeholders that for all electronic sharing of beneficiary information under our final CCM policies, HIPAA standards apply in the usual manner.

      Comment: Several commenters expressed concern about requiring a certified EHR for billing CCM. The commenters were concerned that CMS would not allow the use of non-certified technologies that may be more innovative and effective than certified technologies. Commenters requested that we clarify whether only the certified EHR (and no other electronic tool) could be used to conduct CCM services, for example the use of enhanced communication methods other than telephone. One commenter stated that many times the practice will be using the certified EHR system to carry out such activities, and there are strong Meaningful Use incentives to employ the certified EHR for these activities. However, a practice may also have other capabilities and tools that would support elements of the CCM services. These commenters asked us to clarify whether the requirement to utilize certified EHR technology is a literal statement that only certified EHR technology may be used in furnishing the scope of service elements for CCM services.

      Response: We continue to believe that health IT tools are most effective when there are no technological or business impediments to data sharing, or disparate technology platforms used by multiple practitioners trying to coordinate care. For the separately billable CCM service, we believe it is necessary to establish as part of the scope of the service a certified EHR that allows for the data capture, accessibility and sharing capabilities necessary to furnish the service. Therefore, we are finalizing our proposal to require use of CCM certified technology to meet the final core technology capabilities (structured recording of demographics, problems, medications, medication allergies, and the creation of a structured clinical summary). In addition, whenever a scope of service element references a health or medical record, CCM certified technology must be used to fulfill that scope of service element in relation to the health or medical record. We have listed above the current scope of service elements that include a reference to a health or medical record. If both CCM certified technology and other methods are available to the practitioner to fulfill the final core technology capabilities for CCM (structured recording of demographics, problems, medications, medication allergies, and the creation of a structured clinical summary) or the CCM scope of service elements referencing a the health or medical record, practitioners may only use the certified capability. We remind stakeholders that for all electronic sharing of beneficiary information under our final CCM policies, HIPAA standards apply in the usual manner.

      Comment: One commenter recommended that we adopt the following additional 2014 EHR certification criteria:

      Patient List Creation (45 CFR 170.314(a)(14)), which would support the required element of service for preventive services and routine appointments, and could help provide registry types of functions for the practice to use in managing patients who have agreed to participate in the chronic care management service.

      Patient-Specific Education Resources (Sec. 170.314(a)(15)), which would help assure the ability to provide the patient with relevant educational materials about their chronic disease conditions.

      Clinical Reconciliation (Sec. 170.314(b)(4)), which would serve support the medication reconciliation requirement and the requirement to review patient adherence to their medication regime.

      View/Download/Transmit to a 3rd Party (Sec. 170.314(e)(1)), which would enable patients to access their own electronic health record and have access to information related to their care at their own convenience.

      Secure Messaging, Ambulatory Setting Only (Sec. 170.314(e)(3)).

      Response: Some of these 2014 certification criteria are not relevant (have no corollary) in the 2011 certification criteria, so we would not require them because practitioners are not required to use the 2014 edition in CY 2015. In addition, we are requiring that providers use certified EHR technology to fulfill a limited number of the scope of service elements (summarized in Table 33). We are requiring the certified technology only for certain foundational elements, and believe we should avoid making the EHR requirement for CCM unnecessarily complex at this time. While we agree that the other features of certified EHR products mentioned by the commenter would certainly help many practitioners fulfill the other elements of the CCM

      Page 67727

      service, practitioners may be using tools other than certified technology that are adequate for the required task(s), for example, registry tools for patient list creation, educational resources, patient portals, third party reconciliation services, and secure messaging systems.

      Comment: We received many comments on the scope of service elements other than the EHR, some requesting that we implement additional standards. A few commenters said CMS should consider adding a requirement for use of community based providers through a home visit at least once every 12 months to assess the home environment and the need for community based resources, or that CMS should include home and domiciliary care, group visits and community based care. Several commenters wanted us to include ``remote patient monitoring'' or ``patient generated health data'' in the scope of services, such as daily remote monitoring of physiology and biometrics. Several commenters recommended additional tools for patient self-management education and training, or ``patient activation'' tools. One commenter recommended we require a patient experience survey to assess the patient's perspective regarding the CCM services they receive. Several commenters believed we should expand the medication management and medication reconciliation element to include more comprehensive medication management and more clearly define ``review of adherence'' to the medication regimen.

      Response: Other than the scope of service element for EHR and other electronic technology, we do not believe additional changes to the scope of service elements for CCM are warranted at this time. We are requiring certified EHR technology for certain foundational or ``core'' elements, including structured recording of medications and medication allergies. As finalized in the scope of service in the CY 2014 PFS final rule with comment period we are also requiring medication reconciliation with review of adherence and potential interactions, and oversight of patient self-management of medications. We believe it would be overly burdensome, especially given the broad eligible beneficiary population and final RVU inputs, to include more specific requirements related to medication management, especially when greater specificity is likely not necessary to ensure adequate care. The CCM services are by definition non-face-to-face services; therefore we are not including a requirement for home or domiciliary visits or community based care (although there is a requirement related to coordinating home and community based care). Practitioners who engage in remote monitoring of patient physiological data of eligible beneficiaries may count the time they spend reviewing the reported data towards the monthly minimum time for billing the CCM code, but cannot include the entire time the beneficiary spends under monitoring or wearing a monitoring device. If we believe changes to the scope of service elements are warranted in the future, we will propose them through notice and comment rulemaking taking the comments we received to date into consideration.

      Comment: We received many comments on the scope of service elements other than the EHR, requesting that CMS implement fewer standards. Some commenters believed that other than the ``incident to'' provisions, the scope of service elements are administratively burdensome and it will be difficult for physicians to adequately document that they have fulfilled the requirements. Several commenters did not believe it was necessary to require written beneficiary consent. Others asked that CMS develop model beneficiary consent forms.

      Response: We understand the commenters' concerns about adequate documentation, although this issue is not unique to CCM services. We believe the additional scope of service element for the EHR and electronic sharing of the care plan and clinical summary record will create an electronic ``footprint'' that will facilitate documentation, including documentation of the minimum monthly amount of time spent in providing CCM services.

      Regarding beneficiary consent, we believe written beneficiary consent and its documentation in the medical record is necessary because we are requiring practices to share beneficiaries' protected health information both within and outside of the billing practice in the course of furnishing CCM services and because beneficiaries will be required to pay coinsurance on non-face-to-face services. We do not believe the content or nature of the required consent is so complex that we should develop model formats. If we believe changes to the scope of service elements are warranted in the future, we will propose them through notice and comment rulemaking taking the comments we received to date into consideration.

      In summary, we are finalizing our proposal for the CCM scope of service element for EHR technology as proposed, with the following modification. We are including as an element of the separately billable CCM service the use of, at a minimum, technology certified to the edition(s) of certification criteria that is acceptable for the EHR Incentive Programs as of December 31st of the calendar year prior to the PFS payment year (CCM certified technology), to meet the final core EHR capabilities (structured recording of demographics, problems, medications, medication allergies and the creation of a structured clinical summary record) and to fulfill all activities within the final scope of service elements that reference a health or medical record. For CCM payment in CY 2015, this policy will allow practitioners to use EHR technology certified to either the 2011 or 2014 edition(s) of certification criteria. The final scope of service elements that refer to a health or medical record, and that must be fulfilled using the CCM certified technology, are summarized in Table 33 and include the following:

      A full list of problems, medications and medication allergies in the EHR must inform the care plan, care coordination and ongoing clinical care.

      Communication to and from home and community based providers regarding the patient's psychosocial needs and functional deficits must be documented in the patient's medical record.

      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.

      Provide the beneficiary a written or electronic copy of the care plan and document in the electronic medical record that the care plan was provided to the beneficiary.

      We are finalizing our proposal regarding the electronic care plan scope of service element without modification. To satisfy this element, practitioners must at least electronically capture care plan information; make this information available on a 24/7 basis to all practitioners within the practice who are furnishing CCM services whose time counts towards the time requirement for the practice to bill the CCM code; and share care plan information electronically (other than by facsimile) as appropriate with other practitioners

      Page 67728

      and providers who are furnishing care to the beneficiary. We are not requiring practitioners to use a specific electronic solution to furnish the care plan element of the CCM service, only that the method must be electronic and cannot include facsimile transmission.

      Similarly, we are not requiring practitioners to use a specific tool or service to communicate clinical summaries in managing care transitions, as long as practitioners transmit the clinical summaries electronically, with the exception of faxing which will not fulfill the requirement for exchange of a summary care record. However practitioners must format their clinical summaries according to, at a minimum, the standard that is acceptable for the EHR Incentive Programs as of December 31st of the calendar year preceding each PFS payment year.

      We remind stakeholders that for all electronic sharing of beneficiary information under our final CCM policies, HIPAA standards apply in the usual manner. We summarize the final requirements for the CCM scope of service elements and billing requirements for CY 2015 and their relationship to the final EHR requirements in Table 33.

      Table 33--Summary of Final CCM Scope of Service Elements and Billing

      Requirements for CY 2015

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

      Certified EHR or other

      CCM Scope of service element/billing electronic technology

      requirement requirement

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

      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 care management services 24/7 None.

      (providing the beneficiary with a

      means to make timely contact with

      health care providers in the practice

      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.

      practitioner or member of the care

      team with whom the beneficiary is able

      to get successive routine appointments.

      Care management 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

      medications.

      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 practice whose time counts

      for all health issues. Share the care towards the time requirement

      plan as appropriate with other for the practice to bill the

      practitioners and providers. CCM code; and share care plan

      information electronically

      (other than by fax) as

      appropriate with other

      practitioners and providers.

      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

      and among health care providers and summaries according to CCM

      settings, including referrals to other certified technology.

      clinicians; follow-up after an Not required to use a

      emergency department visit; and follow- specific tool or service to

      up after discharges from hospitals, exchange/transmit clinical

      skilled nursing facilities or other summaries, as long as they are

      health care facilities. transmitted electronically

      (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 practitioner

      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 Document the beneficiary's

      beneficiary of the availability of CCM written consent and

      services and obtain his or her written authorization in the EHR using

      agreement to have the services CCM certified technology.

      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.

      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.

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

      Page 67729

      4. Payment of CCM Services in CMS Models and Demonstrations

      As discussed in section II.G., several CMS models and demonstrations address payment for care management services. The Multi-

      payer Advanced Primary Care Practice (MAPCP) Demonstration and the Comprehensive Primary Care (CPC) Initiative both include payments for care management services that closely overlap with the scope of service for the new chronic care management services code. In these two initiatives, primary care practices are receiving per beneficiary per month payments for care management services furnished to Medicare fee-

      for-service beneficiaries attributed to their practices. We proposed that practitioners participating in one of these two models may not bill Medicare for CCM services furnished to any beneficiary attributed to the practice for purposes of participating in one of these initiatives, as we believe the payment for CCM services would be a duplicative payment for substantially the same services for which payment is made through the per beneficiary per month payment. However, we proposed that these practitioners may bill Medicare for CCM services furnished to eligible beneficiaries who are not attributed to the practice for the purpose of the practice's participation as part of one of these initiatives. As the Innovation Center implements new models or demonstrations that include payments for care management services, or as changes take place that affect existing models or demonstrations, we will address potential overlaps with the CCM service and seek to implement appropriate reimbursement policies. We solicited comments on this proposal. We also solicited comments on the extent to which these services may not actually be duplicative and, if so, how our reimbursement policy could be tailored to address those situations.

      We received several comments that either supported or did not oppose our proposed policy regarding the payment of CCM services in CMS models and demonstrations that also pay for care management services.

      The following is a summary of the other comments we received regarding our proposals on reimbursement policies.

      Comment: Two commenters requested that we reconsider our proposed policy to exclude demonstration practitioners from billing for CCM services to ensure that these practitioners are not disadvantaged relative to those practitioners who do not participate in demonstrations or models.

      Response: Our proposed policy does not exclude practitioners participating in demonstrations or models from billing for CCM services. To reiterate, practitioners participating in demonstrations or models may bill Medicare for CCM services for beneficiaries who are not attributed to the practices for purposes of participating in either the MAPCP or CPC. For beneficiaries who are not attributed to the practice, no care management payment is made under the MAPCP or CPC models. If the beneficiary otherwise meets the criteria for CCM services, the practitioner may furnish and bill Medicare for CCM. However, Medicare will not pay practitioners participating in MAPCP or CPC for CCM services furnished to beneficiaries attributed to the practice for the purpose of the practice's participation in either these models. We believe we have created a pathway to enable practitioners participating in CPC or MAPCP to bill Medicare for the CCM services, as not all beneficiaries treated in a practice will be attributed to the practice.

      Comment: We received two comments expressing concern for confusion that might occur regarding the interaction of CCM services and the CPC model.

      Response: We acknowledge that the Innovation Center will need to engage in extensive communications efforts with practitioners participating in either CPC or MAPCP to inform them of our policies regarding billing for CCM services.

      Comment: One individual commented that payment for CCM ``should not be constrained'' by the payment in a demonstration. The commenter also said, ``The two payments are completely unrelated and are made for different purposes to very different physician practices. Also, we do not believe it is possible to know with certainty whether there is overlap between a feehyphenforhyphenservice chronic care management payment and a payment for care coordination in a demonstration.''

      Response: The proposed policy aims not to constrain practitioners voluntarily participating in Innovation Center models and demonstrations, specifically CPC and MAPCP, by allowing them to bill Medicare for CCM services furnished to beneficiaries for whom they are not receiving payments as part of these initiatives. We expect the practitioners participating in these initiatives will be eligible to bill the CCM service for some beneficiaries, as there is overlap between elements of the CCM service and the models. For example, the CPC model requires practitioners to use electronic health records that have been certified by the National Coordinator for Health Information Technology, provide patients with 24/7 access to the practice, ensure continuity of care with a designated practitioner or care team for each patient, provide care management that includes a systematic assessment of patient needs, use patient-centered care plans, and give enhanced opportunities for patient and caregiver communications. Similarly, the MAPCP demonstration is testing the patient-centered medical home model, which focuses on care management, continuity of care, and care coordination. All practitioners, who are voluntarily participating in these initiatives, receive quarterly reports indicating which beneficiaries have been attributed to their practices. After reviewing and comparing the features of the CPC and MAPCP models with the CCM service, we continue to be convinced that there is overlap. The CCM service provides appropriate payment for care management and care coordination furnished to beneficiaries with multiple chronic conditions within the current fee-for-service Medicare program, while Innovation Center models and demonstrations test alternative payment methods that promote less reliance on a fee-for-service funding stream and support primary care delivery transformation at the practice level to identify potential future alternative approaches to payment.

      In response to these comments, we will engage in extensive communications explaining to practices participating in CMMI models and demonstrations, specifically the CPC and MAPCP initiatives, the policies related to care management payments under these initiatives and the CCM service. We continue to believe the payment for CCM services would be a duplicative payment for substantially the same services included in the per beneficiary per month payment under the CPC and MAPCP models. Therefore, we are finalizing our proposed policy that CMS will not pay practitioners participating in one of these two initiatives for CCM services furnished to any beneficiary attributed by the initiative to the practice. These practitioners may bill Medicare for CCM services furnished to eligible beneficiaries who are not attributed by the initiative to the practice. As the Innovation Center implements new models or demonstrations that include payments for care management services, or as changes take place that affect existing models or demonstrations, we will address potential overlaps with the

      Page 67730

      CCM service and seek to implement appropriate payment policies.

      I. Outpatient Therapy Caps for CY 2015

      Section 1833(g) of the Act requires application of annual, per beneficiary, limitations on the amount of expenses that can be considered as incurred expenses for outpatient therapy services under Medicare Part B, commonly referred to as ``therapy caps.'' There is one therapy cap for outpatient occupational therapy (OT) services and another separate therapy cap for physical therapy (PT) and speech-

      language pathology (SLP) services combined.

      The therapy caps apply to outpatient therapy services furnished in all settings, including the once-exempt outpatient hospital setting (effective October 1, 2012) and critical access hospitals (effective January 1, 2014).

      The therapy cap amounts under section 1833(g) of the Act are updated each year based on the Medicare Economic Index (MEI). Specifically, the annual caps are calculated by updating the previous year's cap by the MEI for the upcoming calendar year and rounding to the nearest $10.00. Increasing the CY 2014 therapy cap of $1,920 by the CY 2015 MEI of 0.8 percent and rounding to the nearest $10.00 results in a CY 2015 therapy cap amount of $1,940.

      An exceptions process for the therapy caps has been in effect since January 1, 2006. Originally required by section 5107 of the Deficit Reduction Act of 2005 (DRA), which amended section 1833(g)(5) of the Act, the exceptions process for the therapy caps has been extended multiple times through subsequent legislation (MIEA-TRHCA, MMSEA, MIPPA, the Affordable Care Act, MMEA, TPTCCA, MCTRJCA, ATRA and PAMA). The Agency's current authority to provide an exceptions process for therapy caps expires on March 31, 2015.

      After expenses incurred for the beneficiary's outpatient therapy services for the year have exceeded one or both of the therapy caps, therapy suppliers and providers use the KX modifier on claims for subsequent services to request an exception to the therapy caps. By use of the KX modifier, the therapist is attesting that the services above the therapy caps are reasonable and necessary and that there is documentation of medical necessity for the services in the beneficiary's medical record.

      Under section 1833(g)(5)(C) of the Act, we are required to apply a manual medical review process to therapy claims when a beneficiary's incurred expenses for outpatient therapy services exceed a threshold amount of $3,700. There are two separate thresholds of $3,700, just as there are two separate therapy caps, one for OT services and one for PT and SLP services combined, and incurred expenses are counted towards the thresholds in the same manner as the caps. The statutorily required manual medical review expires March 31, 2015, consistent with the expiration of the Agency's authority to provide an exceptions process for the therapy caps. For information on the manual medical review process, go to www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medical-Review/TherapyCap.html.

    2. Definition of Colorectal Cancer Screening Tests

      As discussed in the proposed rule (79 FR 40368), section 1861(pp) of the Act defines ``colorectal cancer screening tests'' and, under section 1861(pp)(1)(C), a ``screening colonoscopy'' is one of the recognized procedures. Among other things, section 1861(pp)(1)(D) of the Act authorizes the Secretary to modify the tests and procedures covered under this subsection, ``with such frequency and payment limits, as the Secretary determines appropriate,'' in consultation with appropriate organizations. The current definition of ``colorectal cancer screening tests'' at Sec. 410.37(a)(1) includes ``screening colonoscopies.'' Until recently, the prevailing practice for screening colonoscopies has been moderate sedation provided intravenously by the endoscopist, without resort to separately provided anesthesia.\3\ Based on this prevailing practice, payment for moderate sedation has accordingly been bundled into the payment for the colorectal cancer screening tests, (for example, G0104, G0105). For these procedures, because moderate sedation is bundled into the payment, the same physician cannot also report a sedation code. An anesthesia service can be billed by a second physician.

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

      \3\ Faulx, A. L. et al. (2005). The changing landscape of practice patterns regarding unsedated colonoscopy and propofol use: A national web survey. Gastrointestinal Endoscopy, 62. 9-15.

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

      However, a recent study in The Journal of the American Medical Association (JAMA) cited an increase in the percentage of colonoscopies and upper endoscopy procedures furnished using an anesthesia professional, from 13.5 percent in 2003 to 30.2 percent in 2009 within the Medicare population, with a similar increase in the commercially-

      insured population.\4\ A 2010 study projected that the percentage of this class of procedures involving an anesthesia professional would grow to 53.4 percent by 2015.\5\ These studies suggest that the prevailing practice for endoscopies in general and screening colonoscopies in particular is undergoing a transition, and that anesthesia separately provided by an anesthesia professional is becoming the prevalent practice. In preparation for the proposed rule, we reviewed these studies and analyzed Medicare claims data. We saw the same trend in screening colonoscopies for Medicare beneficiaries with 53 percent of the screening colonoscopies for Medicare claims submitted in 2013 had a separate anesthesia claim reported.

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

      \4\ Liu H, Waxman DA, Main R, Mattke S. Utilization of Anesthesia Services during Outpatient Endoscopies and Colonoscopies and Associated Spending in 2003-2009. (2012). JAMA, 307(11):1178-

      1184.

      \5\ Inadomi, J. M. et al. (2010). Projected increased growth rate of anesthesia professional-delivered sedation for colonoscopy and EGD in the United States: 2009 to 2015. Gastrointestinal Endoscopy, 72, 580-586.

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

      In light of these developments, we expressed our concern in the proposed rule that the mere reference to ``screening colonoscopies'' in the definition of ``colorectal cancer screening tests'' has become inadequate. Indeed, we were convinced that the growing prevalence of separately provided anesthesia services in conjunction with screening colonoscopies reflects a change in practice patterns. Therefore, consistent with the authority delegated by section 1861(pp)(1)(D) of the Act, we proposed to revise the definition of ``colorectal cancer screening tests'' to adequately reflect these new patterns. Specifically, we proposed to revise the definition of ``colorectal cancer screening tests'' at Sec. 410.37(a)(1)(iii) to include anesthesia that is separately furnished in conjunction with screening colonoscopies (79 FR 40369).

      We also stated that our proposal to revise the definition of ``colorectal cancer screening tests'' in this manner would further reduce our beneficiaries' cost-sharing obligations under Part B. Screening colonoscopies have been recommended with a grade of A by the United States Preventive Services Task Force (USPSTF) and Sec. 410.152(l)(5) provides that Medicare Part B pays 100 percent of the Medicare payment amount established under the PFS for colorectal cancer screening tests except for barium enemas (which do not have a grade A or B recommendation from the USPSTF). This regulation is based on section 1833(a)(1) of the Act, as amended by section 4104 of the Affordable Care Act, which requires 100

      Page 67731

      percent Medicare payment of the fee schedule amount for those ``preventive services'' that are appropriate for the individual and are recommended with a grade of A or B by the USPSTF. Section 4104 of the Affordable Care Act amended section 1833(a)(1) of the Act to effectively waive any Part B coinsurance that would otherwise apply for certain recommended preventive services, including screening colonoscopies For additional discussion of the impact of section 4104 of the Affordable Care Act, and our prior rulemaking based on this provision see the CY 2011 PFS final rule with comment period (75 FR 73412 through 73431). We also noted that under Sec. 410.160(b)(7) colorectal cancer screening tests are not subject to the Part B annual deductible and do not count toward meeting that deductible.

      In implementing the amendments made by section 4104 of the Affordable Care Act, we did not provide at that time for waiving the Part B deductible and coinsurance for covered anesthesia services separately furnished in conjunction with screening colonoscopies. At that time, we believed that our payment for the screening colonoscopy, which included payment for moderate sedation services, reflected the typical screening colonoscopy. Under the current regulations, Medicare beneficiaries who receive anesthesia from a different professional than the one furnishing the screening colonoscopy would be incurring costs for the coinsurance and deductible under Part B for those separate services. With the changes in the standard of care and shifting practice patterns toward increased use of anesthesia in conjunction with screening colonoscopy, beneficiaries who receive covered anesthesia services from a different professional than the one furnishing the colonoscopy would incur costs for any coinsurance and any unmet part of the deductible for this component of the service. However, our proposed revision to the definition of ``colorectal cancer screening tests'' would lead to Medicare paying 100 percent of the fee schedule amounts for screening colonoscopies, including any portion attributable to anesthesia services furnished by a separate practitioner in conjunction with such tests, under Sec. 410.152(l)(5). Similarly, this revision would also mean that expenses incurred for a screening colonoscopy, and the anesthesia services furnished in conjunction with such tests, will not be subject to the Part B deductible and will not count toward meeting that deductible under Sec. 410.160(b)(7). We believe the proposal encourages more beneficiaries to obtain a screening colonoscopy, which is consistent with the intent of the statutory provision to waive Medicare cost-

      sharing for certain recommended preventive services, and is consistent with the authority delegated to the Secretary in section 1861(pp)(1)(D) of the Act.

      In light of the changing practice patterns for screening colonoscopies, continuing to require Medicare beneficiaries to bear the deductible and coinsurance expenses for separately billed anesthesia services furnished and covered by Medicare in conjunction with screening colonoscopies could become a significant barrier to these essential preventive services. As we noted when we implemented the provisions of the Affordable Care Act waiving the Part B deductible and coinsurance for these preventive services, the goal of these provisions was to eliminate financial barriers so that beneficiaries would not be deterred from receiving them (75 FR 73412). Therefore, we proposed to exercise our authority under section 1861(pp)(1)(D) of the Act to revise the definition of colorectal cancer screening tests to encourage beneficiaries to seek these services by extending the waiver of coinsurance and deductible to anesthesia or sedation services furnished in conjunction with a screening colonoscopy.

      We noted in the proposed rule (79 FR 40370) that, in implementing these proposed revisions to the regulations, it would be necessary to establish a modifier for use when billing the relevant anesthesia codes for services that are furnished in conjunction with a screening colonoscopy, and thus, qualify for the waiver of the Part B deductible and coinsurance. Therefore, we noted that we would provide appropriate and timely information on this new modifier and its proper use so that physicians will be able to bill correctly for these services when the revised regulations become effective. We also noted that the valuation of colonoscopy codes, which include moderate sedation, would be subject to the same proposed review as other codes that include moderate sedation, as discussed in section II.B.6 of this final rule with comment period.

      The following is a summary of the comments received on this proposal.

      Comment: The majority of commenters strongly supported finalizing our proposal to revise the definition of ``colorectal cancer screening tests'' at Sec. 410.37(a)(1)(iii) to include anesthesia that is furnished in conjunction with screening colonoscopies. However, one commenter expressed concern about the timing of the proposal, and specifically that it leaves little time for implementation in CY 2015. Therefore, the commenter recommended that the proposal should be considered for implementation in CY 2016.

      Response: We appreciate the support for our proposal and are finalizing it as proposed. Specifically, we are revising the definition of ``colorectal cancer screening tests'' at Sec. 410.37(a)(1)(iii) to include anesthesia that is furnished in conjunction with screening colonoscopies. We disagree with the recommendation to delay implementation until CY 2016. The proposed implementation on January 1st following the finalization of the policy in the final rule follows the usual PFS schedule for implementation of payment changes. We are not aware of a reason for deviating from the usual schedule for this policy. Therefore, we are implementing this final rule, effective January 1, 2015.

      Comment: Many commenters urged us to extend our proposed revision, by identifying a way under our existing authority to redefine colorectal cancer screening to include screening colonoscopy with removal of polyp, abnormal growth, or tissue during the screening encounter. Commenters stated that there is already substantial confusion among beneficiaries about why colonoscopy with polyp removal requires payment of coinsurance, while colonoscopy without polyp removal does not. The commenters maintained that our proposal to include anesthesia that is separately furnished in conjunction with screening colonoscopies within the definition of screening colonoscopy would only cause additional confusion, unless screening colonoscopies with removal of polyp, along with any anesthesia separately furnished in conjunction with such procedures, are also included within the definition. Because our proposal rule did not seek to make changes to our policies with respect to diagnostic colonoscopies, the commenters were concerned that, beneficiaries may be liable for part B coinsurance for both diagnostic colonoscopy and any anesthesia furnished in conjunction with the colonoscopy when a polyp is removed. Commenters also stated that extending our proposal in this manner would be good public policy, because it would reduce the disincentives to this essential preventive service posed by possible liability for coinsurance if a polyp is discovered and removed during a screening colonoscopy. The commenters

      Page 67732

      also emphasized that further extending the definition in this way would remove an inconsistency between Medicare policy and the new requirements for private health plans that prohibit the imposition of cost sharing when a polyp is removed under the Affordable Care Act.

      Response: We understand the commenters' concerns, however, we do not have the authority to adopt the recommended revisions by regulation.

      Our authority is limited by the language of the Medicare Act. Specifically, section 1834(d)(3)(D) of the Act states that, ``if during the course of such a screening colonoscopy, a lesion or growth is detected which results in a biopsy or removal of the lesion or growth, payment under this part shall not be made for the screening colonoscopy but shall be made for the procedure classified as a colonoscopy with such biopsy or removal.'' As a result of this statutory provision, when an anticipated screening colonoscopy ends up involving a biopsy or polyp removal, Medicare cannot pay for this procedure as a screening colonoscopy. In these circumstances, Medicare pays 80 percent of the diagnostic colonoscopy procedure and the beneficiary is responsible for paying Part B coinsurance. Under the statute, when a polyp or other growth is removed, beneficiaries are responsible for Part B coinsurance for the diagnostic colonoscopy, and similarly, any Part B coinsurance for any covered anesthesia.

      Comment: Commenters stated that the proposal was not clear on how the deductible will be treated in the case of anesthesia services when a polyp or other tissue is removed during a screening colonoscopy.

      Response: Section 1833(b)(1) of the Act, as amended by section 4104(c) of the Affordable Care Act, waives the Part B deductible for ``colorectal screening tests regardless of the code 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 a screening test.'' We explained this provision in the CY 2011 PFS final rule with comment period (75 FR 73431). We apply this policy to any surgical service furnished on the same date as a planned colorectal cancer screening test. Our regulations at Sec. 410.152(l)(5) already require Medicare Part B to pay 100 percent of the Medicare payment amount for colorectal cancer screening tests (excluding barium enema). The statutory waiver of deductible will apply to the anesthesia services furnished in conjunction with a colorectal cancer screening test even when a polyp or other tissue is removed during a colonoscopy. As in the case of the physician furnishing the colonoscopy service, the anesthesia professional reporting the anesthesia in conjunction with the colonoscopy where a polyp is removed would also report the PT modifier.

      Comment: Commenters urged CMS to provide guidance as to whether CPT code 00810 (Anesthesia for lower intestinal endoscopic procedures, endoscope introduced distal to duodenum) would be billed with a modifier to indicate whether the procedure was screening or not.

      Response: Effective January 1, 2015, beneficiary coinsurance and deductible do not apply to the following anesthesia claim lines billed when furnished in conjunction with screening colonoscopy services and billed with the appropriate modifier (33): 00810 (Anesthesia for lower intestinal endoscopic procedures, endoscope introduced distal to duodenum). Anesthesia professionals who furnish a separately payable anesthesia service in conjunction with a colorectal cancer screening test should include the 33 modifier on the claim line with the anesthesia service. As noted above in situations that begin as a colorectal cancer screening test, but for which another service such as colonoscopy with polyp removal is actually furnished, the anesthesia professional should report a PT modifier on the claim line rather than the 33 modifier.

      Comment: Several commenters recommended that we not only finalize the revised definition of ``colorectal cancer screening tests,'' but also take steps to ensure that our Medicare Administrative Contractors (MACs) are not inappropriately taking actions that have the effect of nullifying some or much of the intended benefit of this policy change. Specifically, these commenters requested that we prevent the current efforts by one or more Medicare contractors to limit Medicare coverage for anesthesia services furnished during a screening colonoscopy by an anesthesia professional. Another commenter urged us to clarify that this proposed expanded definition of colorectal cancer screening to include anesthesia services should not be construed to override or preempt existing or planned coverage policies on the appropriate use of these services by MACs.

      Response: This final rule with comment period establishes national policy and takes precedence over any local coverage policy that limits Medicare coverage for anesthesia services furnished during a screening colonoscopy by an anesthesia professional.

    3. Payment of Secondary Interpretation of Images

      In general, Medicare makes one payment for the professional component of an imaging service for each technical component (TC) service that is furnished. Under ``unusual circumstances,'' physicians can bill for a secondary interpretation using modifier -77, for instance, when an emergency room physician conducts an x-ray, provides an interpretation, identified a questionable finding, and subsequently requests a second interpretation from a radiologist to inform treatment decisions. In all cases, a ``professional component'' (PC) interpretation service should only be billed for a full interpretation and report, rather than a ``review,'' which is paid for as part of an E/M payment.

      In recent years, technological advances such as the integration of picture and archiving communications systems across health systems, growth in image sharing networks and health information exchange platforms through which providers can share images, and consumer-

      mediated exchange of images, have greatly increased physicians' access to existing diagnostic-quality radiology images. Accessing and utilizing these images to inform the diagnosis and record an interpretation in the medical record may allow physicians to avoid ordering duplicative tests.

      We solicited comments on the appropriateness of more routine billing for secondary interpretations, although we did not propose to make any changes to the treatment of these services in 2015. We wanted to determine whether there were an expanded set of circumstances under which more routine Medicare payment for a second PC for radiology services would be appropriate, and whether such a policy would be likely to reduce the incidence of duplicative advanced imaging studies.

      To achieve that goal, we solicited comments on the following: the circumstances under which physicians are currently conducting secondary interpretations and whether they are seeking payment for these interpretations; whether more routine payment for secondary interpretations should be restricted to certain high-cost advanced diagnostic imaging services; considerations for valuing secondary interpretation services; the settings in which secondary interpretations chiefly occur; and considerations for

      Page 67733

      operationalizing more routine payment of secondary interpretations in a manner that would minimize burden on providers and others.

      Comment: Many commenters responded to our secondary interpretation solicitation. In addition to comments on the merits of the proposals, commenters also provided helpful information about how to implement this policy. Commenters offered diverse opinions on the time period for which an existing image would be pertinent in support of a secondary interpretation. Most commenters were in agreement that cost savings would be derived from the implementation of a secondary interpretation policy but there was no consensus as to the amount of such savings. Moreover, many commenters pointed out that they were already furnishing secondary interpretations and would appreciate adoption of a policy that would allow them to receive payment for these services.

      Response: We thank all the commenters for their input. Any changes to our current policy on allowing physicians to more routinely bill for secondary interpretations of images will be addressed in future rulemaking.

      L. Conditions Regarding Permissible Practice Types for Therapists in Private Practice

      Section 1861(p) of the Act defines outpatient therapy services to include physical therapy (PT), occupational therapy (OT), and speech-

      language pathology (SLP) services furnished by qualified occupational therapists, physical therapists, and speech-language pathologists in their offices and in the homes of beneficiaries. The regulations at Sec. Sec. 410.59(c), 410.60(c), and 410.62(c) set forth special provisions for services furnished by therapists in private practice, including basic qualifications necessary to qualify as a supplier of OT, PT, and SLP services, respectively. As part of these basic qualifications, the current regulatory language includes descriptions of the various practice types for therapists' private practices. Based on our review of these three sections of our regulations, we became concerned that the language is not as clear as it could be--especially with regard to the relevance of whether a practice is incorporated. The regulations appear to make distinctions between unincorporated and incorporated practices, and some practice types are listed twice. Accordingly, we proposed changes to the regulatory language to remove unnecessary distinctions and redundancies within the regulations for OT, PT, and SLP. We noted that these changes are for clarification only, and do not reflect any change in our current policy.

      To consistently specify the permissible practice types (a solo practice, partnership, or group practice; or as an employee of one of these) for suppliers of outpatient therapy services in private practice (specifically for occupational therapists, physical therapists and speech-language pathologists), we proposed to replace the regulatory text at Sec. 410.59(c)(1)(ii)(A) through (E), Sec. 410.60(c)(1)(ii)(A) through (E), and Sec. 410.62(c)(1)(ii)(A) through (E) and to replace it with language listing the permissible practice types without limitations for incorporated or unincorporated.

      Comment: We received comments from two therapist membership associations supporting our proposed changes to the regulations. Both commenters agree that the proposed language more consistently and accurately reflects the permissible practice types for therapists in private practice.

      Another commenter representing a membership association of rehabilitation physicians told us that, rather than clarifying or simplifying the existing regulations, the proposed language is more ambiguous. The commenter urged us to clarify that our proposed language would continue to allow therapists in private practice to be employed by physician groups as specified in current provisions.

      Response: We appreciate the commenters' support for our proposal. With regard to the commenter that expressed concern about the clarity of the proposed regulation text as to whether therapists in private practice can be employed by a physician group, we acknowledge that the current regulation explicitly permits that practice arrangement. However, we believe that our proposed language describing the practice arrangements of private practice therapists-a solo practice, partnership, or group practice; or as an employee of one of these-

      clearly continues to permit therapists to practice as an employee of a physician group, whether or not incorporated. We believe the reference in the proposed regulation to ``group practice'' is sufficiently broad to encompass a physician group, and thus permits therapists in private practice to practice as employees of these groups, where permissible under state law.

      Therefore, we are finalizing our proposed changes to the regulations for permissible practice types for therapists in private practice at Sec. 410.59(c)(1)(ii)(A) through (E), Sec. 410.60(c)(1)(ii)(A) through (E), and Sec. 410.62(c)(1)(ii)(A) through(E).

    4. Payments for Practitioners Managing Patients on Home Dialysis

      In the CY 2005 PFS final rule with comment period (69 FR 66357 through 66359), we established criteria for furnishing outpatient per diem ESRD-related services in partial month scenarios. We specified that use of per diem ESRD-related services is intended to accommodate unusual circumstances when the outpatient ESRD-related services would not be paid for under the monthly capitation payment (MCP), and that use of the per diem services is limited to the circumstances listed below.

      Transient patients--Patients traveling away from home (less than full month);

      Home dialysis patients (less than full month);

      Partial month where there were one or more face-to-face visits without the comprehensive visit and either the patient was hospitalized before a complete assessment was furnished, dialysis stopped due to death, or the patient received a kidney transplant.

      Patients who have a permanent change in their MCP physician during the month.

      Additionally, we provided billing guidelines for partial month scenarios in the Medicare claims processing manual, publication 100-04, chapter 8, section 140.2.1. For center-based patients, we specified that if the MCP practitioner furnishes a complete assessment of the ESRD beneficiary, the MCP practitioner should bill for the full MCP service that reflects the number of visits furnished during the month. However, we did not extend this policy to home dialysis (less than a full month) because the home dialysis MCP service did not include a specific frequency of required patient visits. In other words, unlike the ESRD MCP service for center-based patients, a visit was not required for the home dialysis MCP service as a condition of payment.

      In the CY 2011 PFS final rule with comment period (75 FR 73295 through 73296), we changed our policy for the home dialysis MCP service to require the MCP practitioner to furnish at least one face-to-face patient visit per month as a condition of payment. However, we inadvertently did not modify our billing guidelines for home dialysis (less than a full month) to be consistent with partial month scenarios for center-based dialysis patients. As discussed in the CY

      Page 67734

      2015 proposed rule (79 FR 40371) stakeholders have recently brought this inconsistency to our attention. After reviewing this issue, we proposed to allow the MCP physician or practitioner to bill for the age appropriate home dialysis MCP service (as described by HCPCS codes 90963 through 90966) for the home dialysis (less than a full month) scenario if the MCP practitioner furnishes a complete monthly assessment of the ESRD beneficiary and at least one face-to-face patient visit. For example, if a home dialysis patient was hospitalized during the month and at least one face-to-face outpatient visit and complete monthly assessment was furnished, the MCP practitioner should bill for the full home dialysis MCP service. We explained that this proposed change to home dialysis (less than a full month) would provide consistency with our policy for partial month scenarios pertaining to patients dialyzing in a dialysis center. We also stated that if this proposal is adopted, we would modify the Medicare Claims Processing Manual to reflect the revised billing guidelines for home dialysis in the less than a full month scenario.

      A summary of the comments on this proposal and our response is provided below.

      Comment: Several stakeholders strongly supported our proposed change for practitioners managing patients on home dialysis. Specifically, the commenters stated that the proposed change in policy for the home dialysis MCP service is necessary to appropriately align practitioner payment for managing home dialysis patients with center based patients, and encouraged us to finalize the change in policy as proposed. One commenter explained that the current policy for home dialysis less than a full month requires the nephrologist to ``separate out the time their home dialysis patients spend in the hospital and bill for outpatient services at a daily rate instead of the full capitated payment.'' The same commenter stated that ``properly aligning physician payments for managing home dialysis patients (with managing center based dialysis patients) may enable more patients to consider dialyzing at home, when appropriate.''

      Response: We agree with the commenters and will finalize our proposed policy change for home dialysis. We will allow the MCP practitioner to bill for the home dialysis MCP service for the home dialysis (less than a full month) scenario if the MCP practitioner furnishes a complete monthly assessment of the ESRD beneficiary and at least one face-to-face patient visit during the month.

    5. Allowed Expenditures for Physicians' Services and the Sustainable Growth Rate

      1. Medicare Sustainable Growth Rate (SGR)

      The SGR is an annual growth rate that applies to physicians' services paid by Medicare. The use of the SGR is intended to control growth in aggregate Medicare expenditures for physicians' services. Payments for services are not withheld if the percentage increase in actual expenditures exceeds the SGR. Rather, the PFS update, as specified in section 1848(d)(4) of the Act, is adjusted based on a comparison of allowed expenditures (determined using the SGR) and actual expenditures. If actual expenditures exceed allowed expenditures, the update is reduced. If actual expenditures are less than allowed expenditures, the update is increased.

      Section 1848(f)(2) of the Act specifies that the SGR for a year (beginning with CY 2001) is equal to the product of the following four factors:

      (1) The estimated change in fees for physicians' services;

      (2) The estimated change in the average number of Medicare fee-for-

      service beneficiaries;

      (3) The estimated projected growth in real Gross Domestic Product per capita; and

      (4) The estimated change in expenditures due to changes in statute or regulations.

      In general, section 1848(f)(3) of the Act requires us to determine the SGRs for 3 different time periods, using the best data available as of September 1 of each year. Under section 1848(f)(3) of the Act, (beginning with the FY and CY 2000 SGRs) the SGR is estimated and subsequently revised twice based on later data. (The Act also provides for adjustments to be made to the SGRs for FY 1998 and FY 1999. See the February 28, 2003 Federal Register (68 FR 9567) for a discussion of these SGRs). Under section 1848(f)(3)(C)(ii) of the Act, there are no further revisions to the SGR once it has been estimated and subsequently revised in each of the 2 years following the preliminary estimate. In this final rule with comment, we are making our preliminary estimate of the CY 2015 SGR, a revision to the CY 2014 SGR, and our final revision to the CY 2013 SGR.

  41. Physicians' Services

    Section 1848(f)(4)(A) of the Act defines the scope of physicians' services covered by the SGR. The statute indicates that ``the term `physicians' services' includes other items and services (such as clinical diagnostic laboratory tests and radiology services), specified by the Secretary, that are commonly performed or furnished by a physician or in a physician's office, but does not include services furnished to a Medicare Choice plan enrollee.''

    We published a definition of physicians' services for use in the SGR in the November 1, 2001 Federal Register (66 FR 55316). We defined physicians' services to include many of the medical and other health services listed in section 1861(s) of the Act. Since that time, the statute has been amended to add new Medicare benefits. As the statute changed, we modified the definition of physicians' services for the SGR to include the additional benefits added to the statute that meet the criteria specified in section 1848(f)(4)(A).

    As discussed in the CY 2010 PFS final rule with comment period (74 FR 61961), the statute provides the Secretary with clear discretion to decide whether physician-administered drugs should be included or excluded from the definition of ``physicians' services.'' Exercising this discretion, we removed physician-administered drugs from the definition of physicians' services in section 1848(f)(4)(A) of the Act for purposes of computing the SGR and the levels of allowed expenditures and actual expenditures beginning with CY 2010, and for all subsequent years. Furthermore, in order to effectuate fully the Secretary's policy decision to remove drugs from the definition of physicians' services, we removed physician-administered drugs from the calculation of allowed and actual expenditures for all prior years.

    Thus, for purposes of determining allowed expenditures, actual expenditures for all years, and SGRs beginning with CY 2010 and for all subsequent years, we specified that physicians' services include the following medical and other health services if bills for the items and services are processed and paid by Medicare carriers (and those paid through intermediaries where specified) or the equivalent services processed by the Medicare Administrative Contractors:

    Physicians' services.

    Services and supplies furnished incident to physicians' services, except for the expenditures for ``drugs and biologicals which are not usually self-administered by the patient.''

    Outpatient physical therapy services and outpatient occupational therapy services,

    Page 67735

    Services of PAs, certified registered nurse anesthetists, certified nurse midwives, clinical psychologists, clinical social workers, nurse practitioners, and certified nurse specialists.

    Screening tests for prostate cancer, colorectal cancer, and glaucoma.

    Screening mammography, screening pap smears, and screening pelvic exams.

    Diabetes outpatient self-management training (DSMT) services.

    Medical Nutrition Therapy (MNT) services.

    Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests (including outpatient diagnostic laboratory tests paid through intermediaries).

    X-ray, radium, and radioactive isotope therapy.

    Surgical dressings, splints, casts, and other devices used for the reduction of fractures and dislocations.

    Bone mass measurements.

    An initial preventive physical exam.

    Cardiovascular screening blood tests.

    Diabetes screening tests.

    Telehealth services.

    Physician work and resources to establish and document the need for a power mobility device.

    Additional preventive services.

    Pulmonary rehabilitation.

    Cardiac rehabilitation.

    Intensive cardiac rehabilitation.

    Kidney disease education (KDE) services.

    Personalized prevention plan services

  42. Preliminary Estimate of the SGR for 2015

    We first estimated the CY 2015 SGR in March 2014, and we made the estimate available to the MedPAC and on our Web site. Table 34 shows the March 2014 estimate and our current estimates of the factors included in the 2015 SGR. Our March 2014 estimate of the SGR was -3.6 percent. Our current estimate of the 2015 SGR is -13.7 percent. The majority of the difference between the March estimate and our current estimate of the CY 2015 SGR is explained by adjustments to reflect intervening legislative changes that occurred after our March estimate was prepared. Subsequent to the display of the March 2014 estimate, section 101 of the Protecting Access to Medicare Act (PAMA) of 2014 continued a 0.5 percent update to the PFS conversion factor from April 1, 2014, through December 31, 2014 (relative to the 2013 conversion factor), in place of the 24.1 percent reduction that would have occurred under the SGR system on April 1, 2014. In addition, section 101 of PAMA also provides for a 0.0 percent update for services furnished on or after January 1, 2015, through March 31, 2015. While PAMA averted the large reduction in PFS rates scheduled to occur on April 1, 2014, there will be a large reduction in PFS rates on April 1, 2015, as a result of the expiration of the temporary 0.0 percent update. The law and regulation factor of the current estimate of the SGR is now a much larger reduction than previously estimated to account for the current law reduction in PFS rates scheduled to occur on April 1, 2015. We will provide more detail on the change in each of these factors below.

    Table 34--CY 2015 SGR Calculation

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

    Statutory factors March estimate Current estimate

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

    Fees............................ 1.1 percent 0.7 percent

    (1.011). (1.007).

    Enrollment...................... 4.0 percent 3.9 percent

    (1.040). (1.039).

    Real Per Capita GDP............. 0.8 percent 0.7 percent

    (1.008). (1.007).

    Law and Regulation.............. -9.0 percent -18.1 percent

    (0.910). (0.819).

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

    Total....................... -3.6 percent -13.7 percent

    (0.964). (0.863).

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

    Note: Consistent with section 1848(f)(2) of the Act, the statutory

    factors are multiplied, not added, to produce the total (that is,

    1.007 x 1.039 x 1.007 x 0.819 = 0.863). A more detailed explanation of

    each figure is provided in section II.N.1.e. of this final rule with

    comment period.

  43. Revised Sustainable Growth Rate for CY 2014

    Our current estimate of the CY 2014 SGR is -0.8 percent. Table 35 shows our preliminary estimate of the CY 2014 SGR, which was published in the CY 2014 PFS final rule with comment period, and our current estimate. The majority of the difference between the preliminary estimate and our current estimate of the CY 2014 SGR is explained by adjustments to reflect intervening legislative changes that have occurred since publication of the CY 2014 PFS final rule with comment period. The PFS update reduction that would have occurred on April 1, 2014 was averted by PAMA, which has resulted in a much higher legislative factor than our estimate of the 2014 SGR in CY 2014 PFS final rule with comment period. We will provide more detail on the change in each of these factors below.

    Table 35--CY 2014 SGR Calculation

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

    Estimate from CY

    Statutory factors 2014 final rule Current estimate

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

    Fees............................ 0.6 percent 0.7 Percent

    (1.006). (1.007).

    Enrollment...................... 2.2 percent 0.2 Percent

    (1.022). (1.002).

    Real Per Capita GDP............. 0.8 percent 0.7 Percent

    (1.008). (1.007).

    Law and Regulation.............. -19.6 percent -2.4 Percent

    (0.804). (0.976).

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

    Total....................... -16.7 percent -0.8 Percent

    (0.833). (0.992).

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

    Note: Consistent with section 1848(f)(2) of the Act, the statutory

    factors are multiplied, not added, to produce the total (that is,

    1.007 x 1.002 x 1.007 x 0.976 = 0.992). A more detailed explanation of

    each figure is provided in section II.N.1.e. of this final rule with

    comment period.

    Page 67736

  44. Final Sustainable Growth Rate for CY 2013

    The SGR for CY 2013 is 1.3 percent. Table 36 shows our preliminary estimate of the CY 2013 SGR from the CY 2013 PFS final rule with comment period, our revised estimate from the CY 2014 PFS final rule with comment period, and the final figures determined using the best available data as of September 1, 2014. We will provide more detail on the change in each of these factors below.

    Table 36--CY 2013 SGR Calculation

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

    Estimate from CY 2013 Estimate from CY 2014

    Statutory factors final rule final rule Final

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

    Fees................................. 0.3 percent (1.003).... 0.4 percent (1.004).... 0.4 Percent (1.004).

    Enrollment........................... 3.6 percent (1.036).... 1.0 percent (1.010).... 0.5 Percent (1.005).

    Real Per Capita GDP.................. 0.7 percent (1.007).... 0.9 percent (1.009).... 0.9 Percent (1.009).

    Law and Regulation................... -23.3 percent (0.767).. -.05 percent (.995).... -0.5 Percent (0.995).

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

    Total............................ -19.7 percent (0.803... 1.8 percent (1.018).... 1.3 Percent (1.013).

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

    Note: Consistent with section 1848(f)(2) of the Act, the statutory factors are multiplied, not added, to produce

    the total (that is, 1.004 x 1.005 x 1.009 x 0.995 = 1.013). A more detailed explanation of each figure is

    provided in section II.N.1.e. of this final rule with comment period.

  45. Calculation of CYs 2015, 2014, and 2013 SGRs

    (1) Detail on the CY 2015 SGR

    All of the figures used to determine the CY 2015 SGR are estimates that will be revised based on subsequent data. Any differences between these estimates and the actual measurement of these figures will be included in future revisions of the SGR and allowed expenditures and incorporated into subsequent PFS updates.

    (a) Factor 1--Changes in Fees for Physicians' Services (Before Applying Legislative Adjustments) for CY 2015

    This factor is calculated as a weighted average of the CY 2015 changes in fees for the different types of services included in the definition of physicians' services for the SGR. Medical and other health services paid using the PFS are estimated to account for approximately 89.6 percent of total allowed charges included in the SGR in CY 2015 and are updated using the percent change in the MEI. As discussed in section A of this final rule with comment period, the percent change in the MEI for CY 2015 is 0.8 percent. Diagnostic laboratory tests are estimated to represent approximately 10.4 percent of Medicare allowed charges included in the SGR for CY 2015. Medicare payments for these tests are updated by the Consumer Price Index for Urban Areas (CPI-U), which is 2.1 percent for CY 2015. Section 1833(h)(2)(A)(iv) of the Act requires that the CPI-U update applied to clinical laboratory tests be reduced by a multi-factor productivity adjustment (MFP adjustment) and, for each of years 2011 through 2015, by 1.75 percentage points (percentage adjustment). The MFP adjustment will not apply in a year where the CPI-U is zero or a percentage decrease. Further, the application of the MFP adjustment shall not result in an adjustment to the fee schedule of less than zero for a year. However, the application of the percentage adjustment may result in an adjustment to the fee schedule being less than zero for a year and may result in payment rates for a year being less than such payment rates for the preceding year. The applicable productivity adjustment for CY 2015 is -0.6 percent. Adjusting the CPI-U update by the productivity adjustment results in a 1.5 percent (2.1 percent (CPI-U) minus 0.6 percent (MFP adjustment)) update for CY 2015. Additionally, the percentage reduction of 1.75 percent is applied for CYs 2011 through 2015, as discussed previously. Therefore, for CY 2015, diagnostic laboratory tests will receive an update of -0.3 percent. Table 37 shows the weighted average of the MEI and laboratory price changes for CY 2015.

    Table 37--Weighted-Average of the MEI and Laboratory Price Changes for

    CY 2015

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

    Weight Update

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

    Physician..................................... 0.896 0.8%

    Laboratory.................................... 0.104 -0.3%

    Weighted-average.............................. 1.000 0.7%

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

    We estimate that the weighted average increase in fees for physicians' services in CY 2015 under the SGR (before applying any legislative adjustments) will be 0.7 percent.

    (b) Factor 2--Percentage Change in the Average Number of Part B Enrollees from CY 2014 to CY 2015

    This factor is our estimate of the percent change in the average number of fee-for-service enrollees from CY 2014 to CY 2015. Services provided to Medicare Advantage (MA) plan enrollees are outside the scope of the SGR and are excluded from this estimate. We estimate that the average number of Medicare Part B fee-for-service enrollees will increase by 3.9 percent from CY 2014 to CY 2015. Table 38 illustrates how this figure was determined.

    Table 38--Average Number of Medicare Part B Fee-For-Service Enrollees

    from CY 2014 to CY 2015 (Excluding Beneficiaries Enrolled in MA Plans)

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

    CY 2014 CY 2015

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

    Overall......................... 49.350 million.... 50.794 million.

    Medicare Advantage (MA)......... 16.237 million.... 16.389 million.

    Net............................. 33.113 million.... 34.405 million.

    Percent Increase................ 0.2 percent....... 3.9 percent.

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

    An important factor affecting fee-for-service enrollment is beneficiary enrollment in MA plans. Because it is difficult to estimate the size of the MA enrollee population before the start of a CY, at this time we do not know how actual enrollment in MA plans will compare to current estimates. For this reason, the estimate may change substantially as actual Medicare fee-for-service enrollment for CY 2015 becomes known.

    (c) Factor 3--Estimated Real Gross Domestic Product Per Capita Growth in CY 2015

    We estimate that the growth in real GDP per capita from CY 2014 to CY 2015 will be 0.7 percent (based on the annual growth in the 10-year moving average of real GDP per capita 2006 through 2015). Our past experience indicates that there have also been changes in estimates of real GDP per capita growth made before the year begins and the actual change in real

    Page 67737

    GDP per capita growth computed after the year is complete. Thus, it is possible that this figure will change as actual information on economic performance becomes available to us in CY 2015.

    (d) Factor 4--Percentage Change in Expenditures for Physicians' Services Resulting From Changes in Statute or Regulations in CY 2015 Compared With CY 2014

    The statutory and regulatory provisions that will affect expenditures for CY 2015 relative to CY 2014 are estimated to have an impact on expenditures of -18.1 percent. This is primarily due to payment reductions for eligible professionals that are not meaningful users of health information technology, the estimated reduction in PFS rates that will occur on April 1, 2015 absent a change in law, and expiration of the work GPCI floor.

    (2) Detail on the CY 2014 SGR

    A more detailed discussion of our revised estimates of the four elements of the CY 2014 SGR follows.

    (a) Factor 1--Changes in Fees for Physicians' Services (Before Applying Legislative Adjustments) for CY 2014

    This factor was calculated as a weighted-average of the CY 2014 changes in fees that apply for the different types of services included in the definition of physicians' services for the SGR in CY 2014.

    We estimate that services paid using the PFS account for approximately 91.1 percent of total allowed charges included in the SGR in CY 2014. These services were updated using the CY 2014 percent change in the MEI of 0.8 percent. We estimate that diagnostic laboratory tests represent approximately 8.9 percent of total allowed charges included in the SGR in CY 2014. For CY 2014, diagnostic laboratory tests received an update of -0.8 percent.

    Table 39 shows the weighted-average of the MEI and laboratory price changes for CY 2014.

    Table 39--Weighted-Average of the MEI, and Laboratory Price Changes for

    CY 2014

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

    Weight Update

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

    Physician..................................... 0.911 0.8

    Laboratory.................................... 0.089 -0.8

    Weighted-average.............................. 1.000 0.7

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

    After considering the elements described in Table 39, we estimate that the weighted-average increase in fees for physicians' services in CY 2014 under the SGR was 0.7 percent. Our estimate of this factor in the CY 2014 PFS final rule with comment period was 0.6 percent (78 FR 74393).

    (b) Factor 2--Percentage Change in the Average Number of Part B Enrollees from CY 2013 to CY 2014

    We estimate that the average number of Medicare Part B fee-for-

    service enrollees (excluding beneficiaries enrolled in Medicare Advantage plans) increased by 0.2 percent in CY 2014. Table 40 illustrates how we determined this figure.

    Table 40--Average Number of Medicare Part B Fee-For-Service Enrollees

    from CY 2013 to CY 2014 (Excluding Beneficiaries Enrolled in MA Plans)

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

    CY 2013 CY 2014

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

    Overall......................... 47.878 million.... 49.350 million.

    Medicare Advantage (MA)......... 14.842 million.... 16.237 million.

    Net............................. 33.036 million.... 33.113 million.

    Percent Increase................ 0.5 percent....... 0.2 percent.

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

    Our estimate of the 0.2 percent change in the number of fee-for-

    service enrollees, net of Medicare Advantage enrollment for CY 2014 compared to CY 2013, is different than our estimate of an increase of 2.2 percent in the CY 2014 PFS final rule with comment period (78 FR 74393). While our current projection based on data from 8 months of CY 2014 differs from our estimate of 2.2 percent when we had no actual data, it is still possible that our final estimate of this figure will be different once we have complete information on CY 2014 fee-for-

    service enrollment.

    (c) Factor 3--Estimated Real GDP Per Capita Growth in CY 2014

    We estimate that the growth in real GDP per capita will be 0.7 percent for CY 2014 (based on the annual growth in the 10-year moving average of real GDP per capita (2005 through 2014)). Our past experience indicates that there have also been differences between our estimates of real per capita GDP growth made prior to the year's end and the actual change in this factor. Thus, it is possible that this figure will change further as complete actual information on CY 2014 economic performance becomes available to us in CY 2015.

    (d) Factor 4--Percentage Change in Expenditures for Physicians' Services Resulting From Changes in Statute or Regulations in CY 2014 Compared With CY 2013

    The statutory and regulatory provisions that affected expenditures in CY 2014 relative to CY 2013 are estimated to have an impact on expenditures of -2.4 percent. This impact is due to many different legislative or regulatory provisions affecting spending in 2014 relative to 2013 including a 0.5 percent update for PFS services in 2014.

    (3) Detail on the CY 2013 SGR

    A more detailed discussion of our final revised estimates of the four elements of the CY 2013 SGR follows.

    (a) Factor 1--Changes in Fees for Physicians' Services for CY 2013

    This factor was calculated as a weighted average of the CY 2013 changes in fees that apply for the different types of services included in the definition of physicians' services for the SGR in CY 2013.

    We estimate that services paid under the PFS account for approximately 90.1 percent of total allowed charges included in the SGR in CY 2013. These services were updated using the CY 2013 percent change in the MEI of 0.8 percent. We estimate that diagnostic laboratory tests represent approximately 9.9 percent of total allowed charges included in the SGR in CY 2013. For CY 2013, diagnostic laboratory tests received an update of -3.0 percent.

    Table 41 shows the weighted-average of the MEI and laboratory price changes for CY 2013.

    Table 41--Weighted-Average of the MEI, Laboratory, and Drug Price

    Changes for 2013

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

    Weight Update

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

    Physician..................................... 0.901 0.8

    Laboratory.................................... 0.099 -3.0

    Weighted-average.............................. 1.00 0.4

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

    After considering the elements described in Table 41, we estimate that the weighted-average increase in fees for physicians' services in CY 2013 under the SGR (before applying any legislative adjustments) was 0.4 percent. This figure is a final one based on complete data for CY 2013.

    Page 67738

    (b) Factor 2--Percentage Change in the Average Number of Part B Enrollees From CY 2012 to CY 2013

    We estimate the change in the number of fee-for-service enrollees (excluding beneficiaries enrolled in MA plans) from CY 2012 to CY 2013 was 0.5 percent. Our calculation of this factor is based on complete data from CY 2013. Table 42 illustrates the calculation of this factor.

    Table 42--Average Number of Medicare Part B Fee-for-Service Enrollees

    From CY 2012 to CY 2013 (Excluding Beneficiaries Enrolled in MA Plans)

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

    CY 2012 CY 2013

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

    Overall......................... 46.468 million.... 47.878 million.

    Medicare Advantage (MA)......... 13.587 million.... 14.842 million.

    Net............................. 32.881 million.... 33.036 million.

    Percent Change.................. .................. 0.5 percent.

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

    (c) Factor 3--Estimated Real GDP Per Capita Growth in CY 2013

    We estimate that the growth in real per capita GDP was 0.9 percent in CY 2013 (based on the annual growth in the 10-year moving average of real GDP per capita (2004 through 2013)). This figure is a final one based on complete data for CY 2013.

    (d) Factor 4--Percentage Change in Expenditures for Physicians' Services Resulting From Changes in Statute or Regulations in CY 2013 Compared With CY 2012

    Our final estimate for the net impact on expenditures from the statutory and regulatory provisions that affect expenditures in CY 2013 relative to CY 2012 is -0.5 percent. This impact is due to many different legislative or regulatory provisions affecting spending in 2013 relative to 2012, including provisions of the American Taxpayer Relief Act in 2013.

    2. The Update Adjustment Factor (UAF)

    Section 1848(d) of the Act provides that the PFS update is equal to the product of the MEI and the UAF. The UAF is applied to make actual and target expenditures (referred to in the statute as ``allowed expenditures'') equal. As discussed previously, allowed expenditures are equal to actual expenditures in a base period updated each year by the SGR. The SGR sets the annual rate of growth in allowed expenditures and is determined by a formula specified in section 1848(f) of the Act. We note that the conversion factor for the time period from January 1, 2015 through March 31, 2015 will reflect a 0.0 percent update based on section 101 of PAMA. Beginning on April 1, 2015 through December 31, 2015, the standard calculation of the PFS CF under the SGR formula would apply.

    The calculation of the UAF is not affected by sequestration. Pursuant to 2 U.S.C. 906(d)(6), ``The Secretary of Health and Human Services shall not take into account any reductions in payment amounts which have been or may be effected under sequestration, for purposes of computing any adjustments to payment rates under such title XVIII.'' Therefore, allowed charges, which are unaffected by sequestration, were used to calculate physician expenditures in lieu of Medicare payments plus beneficiary cost-sharing. As a result, neither actual expenditures nor allowed expenditures were adjusted to reflect the impact of sequestration.

  46. Calculation Under Current Law

    Under section 1848(d)(4)(B) of the Act, the UAF for a year beginning with CY 2001 is equal to the sum of the following--

    Prior Year Adjustment Component. An amount determined by--

    Computing the difference (which may be positive or negative) between the amount of the allowed expenditures for physicians' services for the prior year (the year prior to the year for which the update is being determined) and the amount of the actual expenditures for those services for that year;

    Dividing that difference by the amount of the actual expenditures for those services for that year; and

    Multiplying that quotient by 0.75.

    Cumulative Adjustment Component. An amount determined by--

    Computing the difference (which may be positive or negative) between the amount of the allowed expenditures for physicians' services from April 1, 1996, through the end of the prior year and the amount of the actual expenditures for those services during that period;

    Dividing that difference by actual expenditures for those services for the prior year as increased by the SGR for the year for which the UAF is to be determined; and

    Multiplying that quotient by 0.33.

    Section 1848(d)(4)(E) of the Act requires the Secretary to recalculate allowed expenditures consistent with section 1848(f)(3) of the Act. As discussed previously, section 1848(f)(3) specifies that the SGR (and, in turn, allowed expenditures) for the upcoming CY (CY 2015 in this case), the current CY (that is, CY 2014) and the preceding CY (that is, CY 2013) are to be determined on the basis of the best data available as of September 1 of the current year. Allowed expenditures for a year generally are estimated initially and subsequently revised twice. The second revision occurs after the CY has ended (that is, we are making the second revision to CY 2013 allowed expenditures in this final rule with comment).

    Table 43 shows the historical SGRs corresponding to each period through CY 2015.

    Page 67739

    GRAPHIC TIFF OMITTED TR13NO14.059

    Consistent with section 1848(d)(4)(E) of the Act, Table 43 includes our second revision of allowed expenditures for CY 2013, a recalculation of allowed expenditures for CY 2014, and our initial estimate of allowed expenditures for CY 2015. To determine the UAF for CY 2015, the statute requires that we use allowed and actual expenditures from April 1, 1996 through December 31, 2014 and the CY 2015 SGR. Consistent with section 1848(d)(4)(E) of the Act, we will be making revisions to the CY 2014 and CY 2015 SGRs and CY 2014 and CY 2015 allowed expenditures. Because we have incomplete actual expenditure data for CY 2014, we are using an estimate for this period. Any difference between current estimates and final figures will be taken into account in determining the UAF for future years.

    We are using figures from EE10 in the following statutory formula:

    Page 67740

    GRAPHIC TIFF OMITTED TR13NO14.060

    Section 1848(d)(4)(D) of the Act indicates that the UAF determined under section 1848(d)(4)(B) of the Act for a year may not be less than -0.07 or greater than 0.03. Since 0.049 (4.9 percent) is greater than 0.03, the UAF for CY 2015 will be 3 percent.

    Section 1848(d)(4)(A)(ii) of the Act indicates that 1.0 should be added to the UAF determined under section 1848(d)(4)(B) of the Act. Thus, adding 1.0 to 0.03 makes the UAF equal to 1.03.

    3. Percentage Change in the MEI for CY 2015

    The MEI is required by section 1842(b)(3) of the Act, which states that prevailing charge levels beginning after June 30, 1973, may not exceed the level from the previous year except to the extent that the Secretary finds, on the basis of appropriate economic index data, that the higher level is justified by year-to-year economic changes. The current form of the MEI was detailed in the CY 2014 PFS final rule (78 FR 74264), which revised and reclassified certain cost categories, price proxies, and expense categories.

    The MEI measures the weighted-average annual price change for various inputs needed to produce physicians' services. The MEI is a fixed-weight input price index, with an adjustment for the change in economy-wide multifactor productivity. This index, which has CY 2006 base year weights, is comprised of two broad categories: (1) Physician's own time; and (2) physician's practice expense (PE).

    The physician's compensation (own time) component represents the net income portion of business receipts and primarily reflects the input of the physician's own time into the production of physicians' services in physicians' offices. This category consists of two subcomponents: (1) Wages and salaries; and (2) fringe benefits.

    The physician's practice expense (PE) category represents nonphysician inputs used in the production of services in physicians' offices. This category consists of wages and salaries and fringe benefits for nonphysician staff (who cannot bill independently) and other nonlabor inputs. The physician's PE component also includes the following categories of nonlabor inputs: office expenses; medical materials and supplies; professional liability insurance; medical equipment; medical materials and supplies; and other professional expenses.

    Table 44 lists the MEI cost categories with associated weights and percent changes for price proxies for the CY 2015 update. The CY 2015 non-productivity adjusted MEI update is 1.7 percent and reflects a 1.9 percent increase in physician's own time and a 1.5 percent increase in physician's PE. Within the physician's PE, the largest increase occurred in postage, which increased 5.4 percent.

    For CY 2015, the increase in the MEI is 0.8 percent, which reflects an increase in the non-productivity adjusted MEI of 1.7 percent and a productivity adjustment of 0.9 percent (which is based on the 10-year moving average of economy-wide private nonfarm business multifactor productivity). The BLS is the agency that publishes the official measure of private non-farm business MFP. Please see http://www.bls.gov/mfp, which is the link to the BLS historical published data on the measure of MFP.

    Table 44--Increase in the Medicare Economic Index Update for CY 2015 \1\

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

    2006 revised cost

    Revised cost category weight (percent) CY15 update

    \2\ (percent)

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

    MEI Total, productivity adjusted... 100.000 0.8

    Productivity: 10-year moving \5\ N/A 0.9

    average of MFP \1\................

    Page 67741

    MEI Total, without productivity 100.000 1.7

    adjustment........................

    Physician Compensation \3\......... 50.866 1.9

    Wages and Salaries............. 43.641 1.9

    Benefits....................... 7.225 2.0

    Practice Expense................... 49.134 1.5

    Non-physician compensation..... 16.553 1.8

    Non-physician wages............ 11.885 1.8

    Non-health, non-physician 7.249 2.0

    wages.....................

    Professional & Related..... 0.800 1.9

    Management................. 1.529 2.2

    Clerical................... 4.720 1.9

    Services................... 0.200 1.2

    Health related, non-physician 4.636 1.5

    wages.........................

    Non-physician benefits......... 4.668 1.9

    Other Practice Expense......... 32.581 1.4

    Utilities.................. 1.266 4.0

    Miscellaneous Office 2.478 1.0

    Expenses..................

    Chemicals.................. 0.723 -1.1

    Paper...................... 0.656 3.3

    Rubber & Plastics.......... 0.598 1.0

    All other products......... 0.500 1.7

    Telephone...................... 1.501 0.0

    Postage........................ 0.898 5.4

    All Other Professional Services 8.095 1.7

    Professional, Scientific, 2.592 1.8

    and Tech. Services........

    Administrative and support 3.052 1.9

    & waste...................

    All Other Services......... 2.451 1.2

    Capital........................ 10.310 1.8

    Fixed...................... 8.957 1.9

    Moveable................... 1.353 0.8

    Professional Liability 4.295 -0.1

    Insurance \4\.................

    Medical Equipment.............. 1.978 -0.3

    Medical supplies............... 1.760 -0.2

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

    \1\ The forecasts are based upon the latest available Bureau of Labor

    Statistics data on the 10-year average of BLS private nonfarm business

    multifactor productivity published on July 9, 2014. (http://www.bls.gov/news.release/prod3.nr0.htm).

    \2\ The weights shown for the MEI components are the 2006 base-year

    weights, which may not sum to subtotals or totals because of rounding.

    The MEI is a fixed-weight, Laspeyres-type input price index whose

    category weights indicate the distribution of expenditures among the

    inputs to physicians' services for CY 2006. To determine the MEI level

    for a given year, the price proxy level for each component is

    multiplied by its 2006 weight. The sum of these products (weights

    multiplied by the price index levels) over all cost categories yields

    the composite MEI level for a given year. The annual percent change in

    the MEI levels is an estimate of price change over time for a fixed

    market basket of inputs to physicians' services.

    \3\ The measures of Productivity, Employment Cost Indexes, as well as

    the various Producer and Consumer Price Indexes can be found on the

    Bureau of Labor Statistics Web site at http://stats.bls.gov.

    \4\ Derived from a CMS survey of several major commercial insurers.

    \5\ Productivity is factored into the MEI categories as an adjustment;

    therefore, no explicit weight exists for productivity in the MEI.

    4. Physician and Anesthesia Fee Schedule Conversion Factors for CY 2015

    The CY 2015 PFS CF for January 1, 2015 through March 31, 2015 is $35.8013. The CY 2015 PFS CF for April 1, 2015 through December 31, 2015 is $28.2239. The CY 2015 national average anesthesia CF for January 1, 2015 through March 31, 2015 is $22.5550. The CY 2015 national average anesthesia CF for April 1, 2015 through December 31, 2015 is $17.7913.

  47. PFS Update and Conversion Factors

    (1) CY 2014 PFS Update

    The formula for calculating the PFS update is set forth in section 1848(d)(4)(A) of the Act. In general, the PFS update is determined by multiplying the CF for the previous year by the percentage increase in the MEI less productivity times the UAF, which is calculated as specified under section 1848(d)(4)(B) of the Act.

    (2) CY 2015 PFS Conversion Factors

    Generally, the PFS CF for a year is calculated in accordance with section 1848(d)(1)(A) of the Act by multiplying the previous year's CF by the PFS update.

    We note section 101 of the Medicare Improvements and Extension Act, Division B of the Tax Relief and Health Care Act of 2006 (MIEA-TRHCA) provided a 1-year increase in the CY 2007 CF and specified that the CF for CY 2008 must be computed as if the 1-year increase had never applied.

    Section 101 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA) provided a 6-month increase in the CY 2008 CF, from January 1, 2008, through June 30, 2008, and specified that the CF for the remaining portion of CY 2008 and the CFs for CY 2009 and subsequent years must be computed as if the 6-month increase had never applied.

    Section 131 of the MIPPA extended the increase in the CY 2008 CF that applied during the first half of the year to the entire year, provided for a 1.1 percent increase to the CY 2009 CF, and specified that the CFs for CY 2010 and subsequent years must be computed as if the increases for CYs 2007, 2008, and 2009 had never applied.

    Section 1011(a) of the DODAA and section 5 of the TEA specified a zero

    Page 67742

    percent update for CY 2010, effective January 1, 2010 through March 31, 2010.

    Section 4 of the Continuing Extension Act of 2010 (CEA) extended the zero percent update for CY 2010 through May 31, 2010.

    Subsequently, section 101(a)(2) of the PACMBPRA provided for a 2.2 percent update to the CF, effective from June 1, 2010 to November 30, 2010.

    Section 2 of the Physician Payment and Therapy Relief Act of 2010 (Pub. L. 111-286) extended the 2.2 percent update through the end of CY 2010.

    Section 101 of the MMEA provided a zero percent update for CY 2011, effective January 1, 2011 through December 31, 2011, and specified that the CFs for CY 2012 and subsequent years must be computed as if the increases in previous years had never applied.

    Section 301 of the Temporary Payroll Tax Cut Continuation Act of 2011 (TPTCCA) provided a zero percent update effective January 1, 2012 through February 29, 2012, and specified that the CFs for subsequent time periods must be computed as if the increases in previous years had never applied.

    Section 3003 of the Middle Class Tax Relief and Job Creation Act of 2012 (Job Creation Act) provided a zero percent update effective March 1, 2012 through December 31, 2012, and specified that the CFs for subsequent time periods must be computed as if the increases in previous years had never applied.

    Section 601 of the American Taxpayer Relief Act (ATRA) of 2012 (Pub. L. 112-240) provided a zero percent update for CY 2013, effective January 1, 2013 through December 31, 2013, and specified that the CFs for subsequent time periods must be computed as if the increases in previous years had not been applied.

    Section 1101 of the Pathway for SGR Reform Act of 2013 (Pub. L. 113-67) provided a 0.5 percent update to the PFS CF, effective January 1, 2014 through March 31, 2014 and specified that the CFs for subsequent time periods must be computed as if the increases in previous years had not been applied.

    Section 101 of the Protecting Access to Medicare Act of 2014 (Pub. L. 113-93) (PAMA) extended this 0.5 percent update through December 31, 2014. Section 101 of the PAMA also provides a 0.0 percent update for services furnished on or after January 1, 2015, through March 31, 2015, and specified that the CFs for subsequent time periods must be computed as if the increases in previous years had not been applied.

    Therefore, under current law, the CF that would be in effect in CY 2014 had the prior increases specified above not applied is $27.2006.

    In addition, when calculating the PFS CF for a year, section 1848(c)(2)(B)(ii)(II) of the Act requires that increases or decreases in RVUs may not cause the amount of expenditures for the year to differ more than $20 million from what it would have been in the absence of these changes. If this threshold is exceeded, we must make adjustments to preserve budget neutrality. We estimate that CY 2015 RVU changes would result in an increase in Medicare physician expenditures of more than $20 million. Accordingly, we are decreasing the CF by 0.06 percent to offset this estimated increase in Medicare physician expenditures due to the CY 2015 RVU changes.

    For January 1, 2015 through March 31, 2015, the PFS update will be 0.0 percent consistent with section 101 of PAMA. After applying the budget neutrality adjustment described above, the conversion factor for January 1, 2015 through March 31, 2015 will be $35.8013.

    After March 31, 2015 the standard calculation of the PFS CF under the SGR formula would apply. Therefore, from April 1, 2015 through December 31, 2015 the conversion factor would be $28.2239. This final rule with comment period announces a reduction to payment rates for physicians' services of 21.2 percent during this time period in CY 2015 under the SGR formula.

    By law, we are required to make these reductions in accordance with section 1848(d) and (f) of the Act, and these reductions can only be averted by an Act of Congress. While Congress has provided temporary relief from these reductions every year since 2003, a long-term solution is critical. We will continue to work with Congress to fix this untenable situation so doctors and beneficiaries no longer have to worry about the stability and adequacy of payments from Medicare under the PFS.

    We illustrate the calculation of the CY 2015 PFS CF in Table 45.

    Table 45--Calculation of the CY 2015 PFS CF

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

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

    January 1, 2015 through March 31, 2015

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

    Conversion Factor in effect in CY .................... $35.8228

    2014.

    Update............................ 0.0 percent (1.00)..

    CY 2015 RVU Budget Neutrality -0.06 percent

    Adjustment. (0.9994).

    CY 2015 Conversion Factor (1/1/ .................... $35.8013

    2015 through 3/31/2015).

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

    April 1, 2015 through December 31, 2015

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

    Conversion Factor in effect in CY .................... $35.8228

    2014.

    CY 2014 Conversion Factor had .................... $27.2006

    statutory increases not applied.

    CY 2015 Medicare Economic Index... 0.8 percent (1.008).

    CY 2015 Update Adjustment Factor.. -3.0 percent (1.03).

    CY 2015 RVU Budget Neutrality -0.06 percent

    Adjustment. (0.9994).

    CY 2015 Conversion Factor (4/1/ .................... $28.2239

    2015 through 12/31/2015).

    Percent Change in Conversion .................... -21.2%

    Factor on 4/1/2015 (relative to

    the CY 2014 CF).

    Percent Change in Update (without .................... -20.9%

    budget neutrality adjustment) on

    4/1/2015 (relative to the CY 2014

    CF).

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

    We note payment for services under the PFS will be calculated as follows:

    Payment = (Work RVU x Work GPCI) (PE RVU x PE GPCI) (Malpractice RVU x Malpractice GPCI) x CF.

  48. Anesthesia Conversion Factors

    We calculate the anesthesia CFs as indicated in Table 46. Anesthesia services do not have RVUs like other PFS services. Therefore, we account for any necessary RVU adjustments through an adjustment to the anesthesia CF to simulate changes to RVUs. More specifically, if there is an adjustment to the work, PE, or malpractice RVUs, these adjustments are applied to the respective shares of the anesthesia CF as

    Page 67743

    these shares are proxies for the work, PE, and malpractice RVUs for anesthesia services. Information regarding the anesthesia work, PE, and malpractice shares can be found at the following: https://www.cms.gov/center/anesth.asp.

    The anesthesia CF in effect in CY 2014 is $22.6765. Section 101 of PAMA provides for a 0.0 percent update from January 1, 2015 through March 31, 2015. After applying the 0.9994 budget neutrality factor described above, the anesthesia CF in effect from January 1, 2015 through March 31, 2015 will be $22.5550.

    The table below includes adjustments to the anesthesia CF that are analogous to the physician fee schedule CF with other adjustments that are specific to anesthesia. In order to calculate the CY 2015 anesthesia CF for April 1, 2015 through December 31, 2015, the statute requires us to calculate the CFs for all previous years as if the various legislative changes to the CFs for those years had not occurred. The resulting CF is then adjusted for the update (the MEI, less multi-factor productivity and increased by the UAF). The national average CF is then adjusted for anesthesia specific work, practice expense and malpractice factors that must be applied to the anesthesia CF as the anesthesia fee schedule does not have RVUs. Accordingly, under current law, the anesthesia CF in effect in CY 2015 for the time period from April 1, 2015 through December 31, 2015 is $17.7913. We illustrate the calculation of the CY 2015 anesthesia CFs in Table 45.

    Table 46--Calculation of the CY 2015 Anesthesia CF

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

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

    January 1, 2015 through March 31, 2015

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

    CY 2014 National Average .................... $22.6765

    Anesthesia CF.

    Update............................ 0.0 percent (1.00)..

    CY 2015 RVU Budget Neutrality 0.0006 percent

    Adjustment. (0.9994).

    CY 2015 Anesthesia Fee Schedule 0.005 percent

    Practice Expense Adjustment. (.99524).

    CY 2015 National Average .................... $22.5550

    Anesthesia CF (1/1/2015 through 3/

    31/2015).

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

    April 1, 2015 through December 31, 2015

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

    2014 National Average Anesthesia .................... $22.6765

    Conversion Factor in effect in CY

    2015.

    2014 National Anesthesia .................... $17.2283

    Conversion Factor had Statutory

    Increases Not Applied.

    CY 2015 Medicare Economic Index... 0.8 percent (1.008).

    CY 2015 Update Adjustment Factor.. 3.0 percent (0.9994)

    CY 2015 Budget Neutrality Work and -0.06 percent

    Malpractice Adjustment. (0.9994).

    CY 2015 Anesthesia Fee Schedule 0.005 percent

    Practice Expense Adjustment. (.99524).

    CY 2015 Anesthesia Conversion .................... $17.7913

    Factor (4/1/2015 through 12/31/

    2015).

    Percent Change from 2014 to 2015 .................... -21.5%

    (4/1/2015 through 12/31/2015).

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

    III. Other Provisions of the Final Rule With Comment Period Regulation

    1. Ambulance Extender Provisions

      1. 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. Recently, section 1104(a) of the Pathway for SGR Reform Act of 2013, enacted on December 26, 2013, as Division B (Medicare and Other Health Provisions) of Pub L. 113-67, amended section 1834(l)(13)(A) of the Act to extend the payment add-ons described above through March 31, 2014. Subsequently, section 104(a) of the Protecting Access to Medicare Act of 2014 (Pub. L. 113-93, enacted on April 1, 2014) amended section 1834(l)(13)(A) of the Act to extend the payment add-ons again through March 31, 2015. Thus, these payment add-ons also apply to covered ground ambulance transports furnished before April 1, 2015. (For a discussion of past legislation extending section 1834(l)(13) of the Act, please see the CY 2014 PFS final rule (78 FR 74438 through 74439)).

      These statutory requirements are 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. In the CY 2015 PFS proposed rule (79 FR 40372), we proposed to revise Sec. 414.610(c)(1)(ii) to conform the regulations to these statutory requirements. We received one comment regarding this proposal. A summary of the comment we received and our response are set forth below.

      Comment: One commenter supported the implementation of the ambulance payment add-ons. The commenter also agreed that these provisions are self-implementing.

      Response: We thank the commenter for their support of these provisions.

      After consideration of the public comment received, we are finalizing our proposal to revise Sec. 414.610(c)(1)(ii) to conform the regulations to these statutory requirements.

      2. 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

      Page 67744

      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 on the CMS-

      supplied ZIP code File.

      The Super Rural Bonus under section 1834(l)(12) of the Act has been extended several times. Recently, section 1104(b) of the Pathway for SGR Reform Act of 2013, enacted on December 26, 2013, as Division B (Medicare and Other Health Provisions) of Pub. L. 113-67, amended section 1834(l)(12)(A) of the Act to extend this rural bonus through March 31, 2014. Subsequently, section 104(b) of the Protecting Access to Medicare Act of 2014 (Pub. L. 113-93, enacted on April 1, 2014) amended section 1834(l)(12)(A) of the Act to extend this rural bonus again through March 31, 2015. 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 April 1, 2015 where transportation originates in a qualified rural area. (For a discussion of past legislation extending section 1834(l)(12) of the Act, please see the CY 2014 PFS final rule (78 FR 74439 through 74440)).

      These statutory provisions are self-implementing. Together, these statutory provisions require a 15-month extension of this rural bonus (which was previously established by the Secretary) through March 31, 2015, and do not require any substantive exercise of discretion on the part of the Secretary. In the CY 2015 PFS proposed rule (79 FR 40372), we proposed to revise Sec. 414.610(c)(5)(ii) to conform the regulations to these statutory requirements. We received one comment regarding this proposal. A summary of the comment we received and our response are set forth below.

      Comment: One commenter supported the implementation of the percent increase in the base rate of the fee schedule for transports in areas defined as super rural. The commenter also agreed with CMS that these provisions are self-implementing.

      Response: We thank the commenter for their support of these provisions.

      After consideration of the public comment received, we are finalizing our proposal to revise Sec. 414.610(c)(5)(ii) to conform the regulations to these statutory requirements.

    2. Changes in Geographic Area Delineations for Ambulance Payment

      1. Background

      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)

  49. 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.

  50. 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. Provisions of the Final Rule

    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 urban and rural differences. This promotes consistency across the Medicare program, and it provides for use of consistent geographic standards for Medicare payment purposes.

    The current geographic areas used under the ambulance fee schedule are 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 (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

    Page 67745

    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 are not as sweeping as the changes made when we adopted the CBSA geographic designations for CY 2007, the February 28, 2013 OMB bulletin does contain a number of significant changes. For example, we stated in the CY 2015 PFS proposed rule (79 FR 40373) that if we adopt the revised OMB delineations, there would be new CBSAs, urban counties that would become rural, rural counties that would become urban, and existing CBSAs that would be split apart. We have reviewed our findings and impacts relating to the new OMB delineations, and find no compelling reason to further delay implementation. We stated in the proposed rule that we believe 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 proposed rule (79 FR 28055), we also proposed to adopt OMB's revised delineations to identify urban areas and rural areas for purposes of the IPPS wage index. This proposal was finalized in the FY 2015 IPPS final rule (79 FR 49952). For the reasons discussed above, we believe 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 proposed to implement the new OMB delineations as described in the February 28, 2013 OMB Bulletin No. 13-01 beginning in CY 2015 to more accurately identify urban and rural areas for ambulance fee schedule payment purposes. We 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), 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), would be recognized as rural areas.

    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 are considered rural areas under the ambulance fee schedule (see Sec. 414.605). For certain rural add-ons, 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 (71 FR 69714 through 69716), we adopted the most recent (at that time) version of the Goldsmith Modification, designated as Rural-Urban Commuting Area (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 (71 FR 69714 through 69716). 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-

    10 American Community Survey. We proposed to adopt the most recent modifications of the RUCA codes beginning in CY 2015, to recognize levels of rurality in census tracts located in every county across the nation, for purposes of payment under the ambulance fee schedule. In the CY 2015 PFS proposed rule (79 FR 40373), we stated that if we adopt the most recent RUCA codes, many counties that are designated as urban at the county level based on population would 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 proposed rule (79 FR 40373 through 40374), 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 (71 FR 69715), we proposed 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 (71 FR 69715), 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

    Page 67746

    HRSA's Web site: ftp://ftp.hrsa.gov/ruralhealth/Eligibility2005.pdf for additional information. Consistent with the HRSA guidelines discussed above, we proposed, beginning in CY 2015, to designate as rural areas (1) those census tracts that fall at or above RUCA level 4.0, and (2) those census tracts that fall within 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 stated in the CY 2015 PFS proposed rule (79 FR 40374) that we continue to believe that HRSA's guidelines accurately identify rural census tracts throughout the country, and thus would be appropriate to apply for ambulance payment purposes. We invited comments on this proposal.

    We stated in the CY 2015 PFS proposed rule (79 FR 40374) that 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, and 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 transport based on the point of pick-up ZIP code that is indicated on the claim.

    Currently, section 1834(l)(12) of the Act (as amended by section 104(b) of the PAMA) specifies that, for services furnished during the period July 1, 2004 through March 31, 2015, 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). We stated in the CY 2015 PFS proposed rule (79 FR 40374) that 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.

    As we stated in the CY 2015 PFS proposed rule (79 FR 40374), the adoption of the new OMB delineations and the updated RUCA codes would affect whether or not transports would be eligible for other 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)). Furthermore, under section 1834(l)(13) of the Act (as amended by section 104(a) of the PAMA), for ground ambulance transports furnished through March 31, 2015, 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)).

    We stated in the CY 2015 PFS proposed rule (79 FR 40374) that if we adopt OMB's revised delineations and the updated RUCA codes, 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 are currently within urban areas) may experience increases in payment for such transports because they may be eligible for the rural adjustment factors discussed above, while 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 are currently in Micropolitan Areas or otherwise outside of MSAs, or in a rural census tract of an MSA) may experience decreases in payment for such transports because they would no longer be eligible for the rural adjustment factors discussed above.

    The use of the revised OMB delineations and the updated RUCA codes would mean the recognition of new urban and rural boundaries based on the population migration that occurred over a 10-year period, between 2000 and 2010. In the CY 2015 PFS proposed rule (79 FR 40374), we stated that, based on the latest United States Postal Service (USPS) ZIP code file, there are a total of 42,914 ZIP codes in the U.S. We stated in the proposed rule that the geographic designations for approximately 99.48 percent of ZIP codes would be unchanged by OMB's revised delineations and the updated RUCA codes, and that a similar number of ZIP codes would change from rural to urban (122, or 0.28 percent) as would change from urban to rural (100, or 0.23 percent). We stated in the proposed rule that, in general, it was expected that ambulance providers and suppliers in 100 ZIP codes within 11 states may experience payment increases if we adopt the revised OMB delineations and the updated RUCA codes, as these areas would be redesignated from urban to rural. We stated that the state of Ohio would have the most ZIP codes changing from urban to rural with a total of 40, or 2.69 percent. We also stated in the CY 2015 PFS proposed rule that ambulance providers and suppliers in 122 ZIP codes within 22 states may experience payment decreases if we adopt the revised OMB delineations and the updated RUCA codes, as these areas would be redesignated from rural to urban. We stated that the state of West Virginia would have the most ZIP codes changing from rural to urban (17, or 1.82 percent), while Connecticut would have the greatest percentage of ZIP codes changing from rural to urban (15 ZIP codes, or 3.37 percent). Our findings were illustrated in Table 17 of the CY 2015 PFS proposed rule (79 FR 40375).

    We stated in the CY 2015 PFS proposed rule (79 FR 40375 and 40376) that 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 that use of the most current OMB delineations and RUCA codes under the ambulance fee schedule would enhance the accuracy of ambulance fee schedule payments. We solicited comments on our proposal to implement the new OMB delineations and the updated RUCA codes as discussed above beginning in CY 2015, for purposes of payment under the Medicare ambulance fee schedule.

    We received four comments from two associations representing ambulance service providers and suppliers and two ambulance suppliers on our proposal to implement the new OMB delineations and the updated RUCA codes for purposes of payment under the Medicare ambulance fee schedule. Those comments are summarized below along with our responses.

    Comment: All of the commenters agreed with CMS that it is appropriate to adjust the geographic area designations periodically so that the ambulance fee schedule reflects population shifts.

    Response: We appreciate the support of the commenters.

    Comment: Commenters expressed concern that the analysis of the proposed modification in the CY 2015 PFS proposed rule did not describe the actual impact of the proposed change

    Page 67747

    because it did not take into account the most recent modifications to the RUCA codes. When these codes are applied, the commenters stated that there would be substantially more ZIP codes that would shift. The commenters estimated that more than 1,500 ZIP codes would shift from rural to urban and about three times the number of ZIP codes identified in the proposed rule would change from urban to rural. The commenters also stated that some ZIP codes would no longer have super rural status.

    Response: The commenters are correct that the analysis published in the CY 2015 PFS proposed rule (see Table 17 (79 FR 40375)) presented the impact of the revised OMB delineations only and did not include the impact of the updated RUCA codes. We did not receive the ZIP code approximation of the 2010 RUCA codes file in time to be included in our analysis in the proposed rule.

    We have completed an updated analysis of both the revised OMB delineations and the updated RUCA codes. Based on the latest United States Postal Service (USPS) ZIP code file, there are a total of 42,918 ZIP codes in the U.S. Based on our updated analysis, we have concluded that the geographic designations for approximately 92.02 percent of ZIP codes would be unchanged by OMB's revised delineations and the updated RUCA codes. There are more ZIP codes that would change from rural to urban (3,038 or 7.08 percent) than from urban to rural (387 or 0.90 percent). The differences in the data provided in the proposed rule compared to the final rule are due to inclusion of the updated RUCA codes. In general, it is expected that ambulance providers and suppliers in 387 ZIP codes within 41 states, may 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 California has the most ZIP codes changing from urban to rural with a total of 43, or 1.58 percent. Ambulance providers and suppliers in 3,038 ZIP codes within 46 states and Puerto Rico may 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 Pennsylvania has the most ZIP codes changing from rural to urban (293, or 13.06 percent), while West Virginia has the greatest percentage of ZIP codes changing from rural to urban (269 ZIP codes, or 28.74 percent). Our findings are illustrated in Table 47.

    BILLING CODE 4120-01-P

    Page 67748

    GRAPHIC TIFF OMITTED TR13NO14.062

    Page 67749

    GRAPHIC TIFF OMITTED TR13NO14.063

    BILLING CODE 4120-01-C

    As discussed above, in the CY 2015 PFS proposed rule (79 FR 40374), we proposed to designate as rural those census tracts that fall in RUCA codes 2 or 3 that are at least 400 square miles in area with a population density of no more than 35 people. However, upon further analysis, we have determined that it is not feasible to implement this proposal. 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 a consistent payment system. Therefore, such census tracts were not considered rural areas in the updated analysis set forth above.

    For more detail on the impact of these changes, in addition to Table 47, the following files are available through the Internet on the AFS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AmbulanceFeeSchedule/index.html: ZIP codes by state that changed from urban to rural, ZIP codes by state that changed from rural to urban, list of ZIP codes with RUCA code designations, and a complete list of ZIP codes identifying their designation as super rural, rural or urban.

    As reflected in Table 47, our findings are generally consistent with the commenters' findings that more than 1,500 ZIP codes would change from rural to urban (our updated analysis indicates that 3,038 ZIP codes are changing), and that about three times the number of ZIP codes identified in the proposed rule (100) would change from urban to rural (our updated analysis indicates 387 ZIP codes are changing).

    As we stated in the proposed rule (79 FR 40374), none of the current super rural areas will lose their super rural status upon implementation of the revised OMB delineations and the updated RUCA codes.

    Comment: One commenter suggested that we delay the implementation of the adjustment until CY 2016 to allow CMS sufficient time to publish the changes in

    Page 67750

    rural and urban status and allow all interested parties to provide comments on the proposal. In addition to delaying implementation, the commenter suggested implementing a 4-year transition that would phase-

    in the payment reduction over a specified period for those ZIP codes losing rural status.

    Other commenters requested that the implementation of the geographic adjustments outlined in the proposed rule be delayed until such time as the data is available to complete a full and accurate analysis of the ZIP codes affected and the financial impact to industry. Absent such a delay, the commenters stated that the final rule must clarify, in a complete and transparent manner, the accuracy of the analysis used in the proposed rule.

    Response: We believe that ambulance providers and suppliers had sufficient notice of and opportunity to comment on the proposed adoption of the revised OMB delineations and the updated RUCA codes under the ambulance fee schedule, and thus we do not believe a delay in implementation is warranted. In the proposed rule, we proposed to adopt the revised OMB delineations as set forth in OMB Bulletin No. 13-01 and the updated RUCA codes for purposes of payment under the ambulance fee schedule consistent with the policy we implemented in CY 2007 (see the CY 2007 PFS final rule (71 FR 69713 through 69716)). We explained in the proposed rule that the adoption of the revised OMB delineations and updated RUCA codes would affect the urban/rural designation of certain areas, and thus would affect whether transports in certain areas would be eligible for rural adjustments under the ambulance fee schedule. In addition, OMB Bulletin No. 13-01was available on February 28, 2013, and contained additional information regarding the changes in OMB geographic area delineations. As discussed above, the ZIP code analysis set forth in the proposed rule reflected the impact of the revised OMB delineations. The 2010 RUCA codes and definitions were available on December 31, 2013 on the U.S. Department of Agriculture's Economic Research Service's Web site, which provided ambulance providers and suppliers with additional information regarding changes to the level of rurality in census tracts. Furthermore, section 1834(l) requires that we use the most recent modification of the Goldsmith Modification to determine rural census tracts for purposes of certain rural add-ons, and our established policy, as set forth in Sec. 414.605, is that rural areas include rural census tracts as determined under the most recent version of the Goldsmith modification.

    As discussed above and in the CY 2015 PFS proposed rule, 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. We 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. Areas that lose 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 would disadvantage the ambulance providers or suppliers experiencing payment increases based on these updated and more accurate OMB delineations and RUCA codes.

    Finally, given the relatively small percentage of ZIP codes affected by the revised OMB delineations and updated RUCA codes (a total of 3,425 ZIP codes changing their urban/rural status out of 42,918 ZIP codes, or 7.98 percent), we do not believe that a delay is warranted. As commenters requested, we have included in Table 47 our updated analysis of the impact of adopting the revised OMB delineations and the updated RUCA codes.

    Comment: One commenter recommended that if any ZIP codes would lose their super rural status as a result of the proposed adoption of the revised OMB delineations and the updated RUCA codes, then CMS should grandfather the current super rural ZIP codes. Another commenter stated that the ambulance providers must have verification from CMS that the super rural ZIP codes will not be affected by the changes described in the proposed rule in advance of their implementation in the final rule.

    Response: As we stated previously, the adoption of the OMB's revised delineations and the updated RUCA codes will have no negative impact on ambulance transports in super rural areas, as none of the current super rural areas will lose their status upon implementation of the revised OMB delineations and the updated RUCA codes. Current areas designated as super rural areas will continue to be eligible for the super rural bonus.

    After consideration of the public comments received, and for the reasons discussed above, we are finalizing our proposals to adopt, 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 RUCA codes for purposes of payment under the ambulance fee schedule. As we proposed, using the updated RUCA codes definitions, we will continue to designate any census tracts falling at or above RUCA level 4.0 as rural areas. However, as discussed above, we are not finalizing our proposal to designate as rural those census tracts that fall within RUCA codes 2 or 3 that are at least 400 square miles in area with a population density of no more than 35 people. Finally, as discussed above, none of the current super rural areas will lose their super rural status upon implementation of the revised OMB delineations and the updated RUCA codes.

    1. Clinical Laboratory Fee Schedule

      In the CY 2014 PFS final rule with comment period (78 FR 74440 through 74445, 74820), we finalized a process under which we would reexamine the payment amounts for test codes on the Clinical Laboratory Fee Schedule (CLFS) for possible payment revision based on technological changes beginning with the CY 2015 proposed rule, and we codified this process at Sec. 414.511. After we finalized this process, the Congress enacted the PAMA. Section 216 of the PAMA creates new section 1834A of the Act, which requires us to implement a new Medicare payment system for clinical diagnostic laboratory tests based on private payor rates. Section 216 of the PAMA also rescinds the statutory authority in section 1833(h)(2)(A)(i) of the Act for adjustments based on technological changes for tests furnished on or after April 1, 2014 (PAMA's enactment date). As a result of these provisions, we did not propose any revisions to payment amounts for test codes on the CLFS based on technological changes, and we proposed to remove Sec. 414.511.

      We did not receive any public comments on this proposal. Therefore, we are finalizing our proposal to remove Sec. 414.511. In addition, we will establish through rulemaking the parameters for

      Page 67751

      the collection of private payor rate information and other requirements to implement section 216 of the PAMA.

    2. Removal of Employment Requirements for Services Furnished ``Incident to'' Rural Health Clinics (RHC) and Federally Qualified Health Center (FQHC) Visits

      1. Background

      Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) furnish physicians' services; services and supplies ``incident to'' the services of physicians: Nurse practitioner (NP), physician assistant (PA), certified nurse-midwife (CNM), clinical psychologist (CP), and clinical social worker (CSW) services; and services and supplies incident to the services of NPs, PAs, CNMs, CPs, and CSWs. They may also furnish diabetes self-management training and medical nutrition therapy (DSMT/MNT), transitional care management services, and in some cases, visiting nurse services furnished by a registered professional nurse or a licensed practical nurse. (For additional information on coverage requirements for services furnished in RHCs and FQHCs, see Chapter 13 of the CMS Benefit Policy Manual.)

      In the May 2, 2014 final rule with comment period entitled ``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'' (79 FR 25436), we removed the regulatory requirements that NPs, PAs, CNMs, CSWs, and CPs furnishing services in a RHC must be employees of the RHC. RHCs are now allowed to contract with NPs, PAs, CNMs, CSWs, and CPs, as long as at least one NP or PA is employed by the RHC, as required under clause (iii) in the first sentence of the flush material following subparagraph (K) of section 1861(aa)(2) of the Act.

      Services furnished in RHCs and FQHCs by nurses, medical assistants, and other auxiliary personnel are considered ``incident to'' a RHC or FQHC visit furnished by a RHC or FQHC practitioner. Sections 405.2413(a)(6), 405.2415(a)(6), and 405.2452(a)(6) currently state that services furnished incident to an RHC or FQHC visit must be furnished by an employee of the RHC or FQHC. Since there is no separate benefit under Medicare law that specifically authorizes payment to nurses, medical assistants, and other auxiliary personnel for their professional services, they cannot bill the program directly and receive payment for their services, and can only be remunerated when furnishing services to Medicare patients in an ``incident to'' capacity.

      To provide RHCs and FQHCs with as much flexibility as possible to meet their staffing needs, we proposed to revise Sec. 405.2413(a)(5), Sec. 405.2415(a)(5) and Sec. 405.2452(a)(5) and delete Sec. 405.2413(a)(6), Sec. 405.2415(a)(6) and Sec. 405.2452(a)(6) to remove the requirement that services furnished incident to an RHC or FQHC visit must be furnished by an employee of the RHC or FQHC, in order to allow nurses, medical assistants, and other auxiliary personnel to furnish ``incident to'' services under contract in RHCs and FQHCs. We believe that removing the requirements will provide RHCs and FQHCs with additional flexibility without adversely impacting the quality or continuity of care.

      We received 23 comments on our proposal. The following is a summary of the comments received.

      Comment: Most commenters were strongly in favor of removing these employment requirements. Several commenters stated that this flexibility will assist RHCs and FQHCs in increasing access to care, enable them to recruit highly qualified health professionals, and fill temporary staffing voids without adversely impacting the quality of care. Some commenters expressed concerns about maintaining professional standards, and others were concerned about the potential loss of benefits for contracted staff.

      A few commenters stated that they support removal of the employment requirement, provided that RHC and FQHC auxiliary personnel are held to the same high professional standards for the quality of care, regardless of whether they are working under contract or as employees. Commenters also added that all members of a physician-led health care team should be enabled to perform medical interventions that they are capable of performing according to their education, training, licensure, and experience.

      Response: The proposal to remove the requirement that auxiliary workers in RHCs and FQHCs be employees of the RHC or FQHC does not change either their professional standards of care or their scope of practice. Nurses, medical assistants, and other auxiliary personnel are expected to maintain their professional standards of care and furnish services in adherence to their scope of practice, regardless of whether they are employed or contracted by the RHC or FQHC.

      Comment: Some commenters stated that although they understand the need for greater staffing flexibility, they were concerned about the potential loss of benefit packages to individuals that are contracted and not employed. The commenters questioned whether the issue was investigated or vetted, and how RHCs and FQHCs would compensate for this loss of compensation for individuals providing incident to services under contract rather than as an employee.

      Response: We appreciate the concern that these commenters raised regarding the potential loss of benefit packages for contracted individuals; however, we do not regulate employment agreements or benefit packages for individuals working at RHCs and FQHCs.

      After consideration of the public comments, we are finalizing this provision as proposed.

    3. Access to Identifiable Data for the Center for Medicare and Medicaid Innovation Models

      1. Background and Statutory Authority

      Section 3021 of the Affordable Care Act amended the Social Security Act to include a new section 1115A, which established the Center for Medicare and Medicaid Innovation (Innovation Center). Section 1115A tasks the Innovation Center with testing innovative payment and service delivery models that could reduce program expenditures while preserving and/or enhancing the quality of care furnished to individuals under titles XVIII, XIX, and XXI of the Act. The Secretary is also required to conduct an evaluation of each model tested.

      Evaluations will typically include quantitative and qualitative methods to assess the impact of the model on quality of care and health care expenditures. To comply with the statutory requirement to evaluate all models conducted under section 1115A of the Act, we will conduct rigorous quantitative analyses of the impact of the model test on health care expenditures, as well as an assessment of measures of the quality of care furnished under the model test. Evaluations will also include qualitative analyses to capture the qualitative differences between model participants, and to form the context within which to interpret the quantitative findings. Through the qualitative analyses, we will assess the experiences and perceptions of model participants, providers, and individuals affected by the model.

      In the evaluations we use advanced statistical methods to measure

      Page 67752

      effectiveness. Our methods are intended to provide results that meet a high standard of evidence, even when randomization is not feasible. To successfully carry out evaluations of Innovation Center models, we must be able to determine specifically which individuals are receiving services from or are the subject of the intervention being tested by the entity participating in the model test. Identification of such individuals is necessary for a variety of purposes, including the construction of control groups against which model performance can be compared. In addition, to determine whether the observed impacts are due to the model being tested and not due to differences between the intervention and comparison groups, our evaluations will have to account for potential confounding factors at the individual level, which will require the ability to identify every individual associated with the model test, control or comparison groups, and the details of the intervention at the individual level.

      Evaluations will need to consider such factors as outcomes, clinical quality, adverse effects, access, utilization, patient and provider satisfaction, sustainability, potential for the model to be applied on a broader scale, and total cost of care. Individuals receiving services from or who are the subjects of the intervention will be compared to clinically, socio-demographically, and geographically similar matched individuals along various process, outcome, and patient-reported measures. Research questions in a typical evaluation will include, but are not limited to, the following:

      Clinical Quality:

      Did the model improve or have a negative impact on clinical process measures, such as adherence to evidence-based guidelines? If so, how, how much, and for which individuals?

      Did the model improve or have a negative impact on clinical outcome measures, such as mortality rates, and the incidence and prevalence of chronic conditions? If so, how, how much, and for which individuals?

      Did the model improve or have a negative impact on access to care? If so, how, how much, and for which individuals?

      Did the model improve or have a negative impact on care coordination among providers? If so, how, how much, and for which individuals?

      Did the model improve or have a negative impact on medication management? If so, how, how much, and for which individuals?

      Patient Experience:

      Did the model improve or have a negative impact on patient-

      provider communication? If so, how, how much, and for which individuals?

      Did the model improve or have a negative impact on patient experiences of care, quality of life, or functional status? If so, how, how much, and for which individuals?

      Utilization/Expenditures:

      Did the model result in decreased utilization of emergency department visits, hospitalizations, and readmissions? If so how, how much, and for which individuals?

      Did the model result in increased utilization of physician or pharmacy services? If so how, how much, and for which individuals?

      Did the model result in decreased total cost of care? Were changes in total costs of care driven by changes in utilization for specific types of settings or health care services? What specific aspects of the model led to these changes? Were any savings due to improper cost-shifting to the Medicaid program?

      To carry out this research we must have access to patient records not generally available to us. As such, we proposed to exercise our authority in section 1115A(b)(4)(B) of the Act to establish requirements for states and other entities participating in the testing of past, present, and future models under section 1115A of the Act to collect and report information that we have determined is necessary to monitor and evaluate such models. Thus, we proposed to require model participants, and providers and suppliers working under the models operated by such participants, to produce such individually identifiable health information and such other information as the Secretary identifies as being necessary to conduct the statutorily mandated research described above. Such research will include the monitoring and evaluation of such models. Further, we view engagement with other payers, both public and private, as a critical driver of the success of these models. CMS programs constitute only a share of any provider's revenue. Therefore, efforts to improve quality and reduce cost are more likely to be successful if efforts are aligned across payers. Section 1115A of the Act specifically allows the Secretary of Health and Human Services to consider, in selecting which models to choose for testing, ``whether the model demonstrates effective linkage with other public sector or private sector payers.'' Multi-payer models, such as but not limited to the Comprehensive Primary Care model, will conduct quality measurement across all patients regardless of payer in order to maximize alignment and increase efficiency. Construction of multi-payer quality measures requires the ability to identify all individuals subject to the model test regardless of payer. In addition, section 1115A also permits the Secretary to consider models that allow states to test and evaluate systems of all-payer payment reform for the medical care of residents of the state, including dual eligible individuals. Under the State Innovation Model (SIM), the Innovation Center is testing the ability for state governments to accelerate transformation. The premise of the SIM initiative is to support Governor-sponsored, multi-payer models that are focused on public and private sector collaboration to transform the state's payment and delivery system. States have policy and regulatory authorities, as well as ongoing relationships with private payers, health plans, and providers that can accelerate delivery system reform. SIM models must impact the preponderance of care in the state and are expected to work with public and private payers to create multi-payer alignment. The evaluation of SIM will include all populations and payers involved in the state initiative, which in many cases includes private payers. The absence of identifiable data from private payers would result in considerable limitations on the level of evaluation conducted. Therefore, under this authority, we also proposed to require the submission of identifiable health and utilization information for patients of private payers treated by providers/suppliers participating in the testing of a model under section 1115A of the Act when an explicit purpose of the model test is to engage private sector payers. This regulation will provide clear legal authority for Health Insurance Portability and Accountability Act (HIPAA) Covered Entities to disclose any required protected health information. Identifiable data submitted by entities participating in the testing of models under section 1115A of the Act will meet CMS Acceptable Risks Safeguards (ARS) guidelines. When data is expected to be exchanged over the internet, such exchange will also meet all E-Gov requirements. In accordance with the requirements of the Privacy Act of 1974, upon receipt by CMS or its contractors, these data will be covered under a CMS-established system of records (System No. 09-70-0591), which serves as the Master system for all demonstrations, evaluations, and research studies administered by the Innovation Center. These data will be

      Page 67753

      stored until the evaluation is complete and all necessary policy deliberations have been finalized.

      2. Provisions of the Proposed Regulations

      Wherever possible, evaluations will make use of claims, assessment, and enrollment data available through CMS' existing administrative systems. However, evaluations will generally also need to include additional data not available through existing CMS administrative systems. As such, depending on the particular project, CMS or its contractor will require the production of the minimum data necessary to carry out the statutorily mandated research work described in section E.1. of this final rule with comment period. Such data may include the identities of the patients served under the model, relevant clinical details about the services furnished and outcomes achieved, and any confounding factors that might influence the evaluation results achieved through the delivery of such services. For illustrative purposes, below are examples of some of the types of information that could be required to carry out an evaluation, and for which the evaluator would need patient-level identifiers.

      Utilization data not otherwise available through existing Centers for Medicare & Medicaid Services (CMS) systems.

      Beneficiary, patient, participant, family, and provider experiences.

      Beneficiary, patient, participant, and provider rosters with identifiers that allow linkages across time and datasets.

      Beneficiary, patient, participant, and family socio-

      demographic and ethnic characteristics.

      Care management details, such as details regarding the provision of services, payments or goods to beneficiaries, patients, participants, families, or other providers.

      Beneficiary, patient, and participant functional status and assessment data.

      Beneficiary, patient, and participant health behaviors.

      Clinical data, such as, but not limited to lab values and information from EHRs.

      Beneficiary, patient, participant quality data not otherwise available through claims.

      Other data relevant to identified outcomes--for example, participant employment status, participant educational degrees pursued/

      achieved, and income.

      We invited public comment on this proposal to mandate the production of the individually identifiable information necessary to conduct the statutorily mandated research under section 1115A of the Act.

      In addition, we proposed a new subpart K in part 403 to implement section 1115A of the Act.

      The following is a summary of the comments we received regarding our proposal to mandate the production of the individually identifiable information necessary to conduct the statutorily mandated research under section 1115A of the Act.

      Comment: Commenters consistently recognized the need to evaluate Innovation Center models as an important component of the effort to test new payment and service delivery models. Further, several commenters supported the need for rigorous evaluations that include control groups. One commenter further recommended the Innovation Center make the aggregated de-identified data from evaluations available to external researchers. Although supportive of the need to evaluate Innovation Center models, several commenters stated the Innovation Center had not sufficiently justified the need for individually identifiable patient information, and suggested aggregate or de-

      identified data should be sufficient. One commenter suggested the submission of performance rates, patient outcomes information, and/or composite scores for participating providers instead of individual patient-level data. The commenter further stated that CMS should not have access to proprietary patient-level data in registries. Some of the commenters stated CMS should publish its evaluation methodologies and solicit feedback from independent research experts as to the need for patient-level data.

      Response: We appreciate the commenters' support for rigorous evaluations, and understand the desire for access to the aggregate de-

      identified data from these evaluations. We always make our data available in accordance with applicable law, HHS and CMS policies, and, where relevant, the availability of funding. Such laws include HIPAA, the Privacy Act, the Trade Secrets Act and the Freedom of Information Act. With respect to comments recommending the use of aggregate or de-

      identified data instead of individually identifiable data, as we discussed in the preamble of the proposed rule, we believe individually identifiable data is necessary. As noted in this final rule with comment and in the preamble of our proposed rule, evaluations will need to consider such factors as outcomes, clinical quality, adverse effects, access, utilization, patient and provider satisfaction, sustainability, potential for the model to be applied on a broader scale, and total cost of care. Furthermore, individuals receiving services from or who are the subjects of the intervention will be compared to clinically, socio-demographically, and geographically similar matched individuals along various process, outcome, and patient-reported measures. Many of these assessments will require person-level data. We will make use of aggregate information on system performance through the use of provider submitted aggregate performance rates for selected measures, patient outcomes information, and/or composite scores. However, without the ability to identify specifically which beneficiaries are receiving services as a result of the model, the evaluation analyses could include individuals not even subject to the intervention, and therefore, there would be a very real possibility that positive impacts of the model may be diluted and unobservable. While aggregate data could be limited to the target population, identification of which individuals are within the target population of the model, are receiving items and services under the model, or are subject to the interventions being tested under the model will also allow the evaluators to construct matched comparison groups that look as similar as possible to the intervention group. The absence of a well-matched comparison group, which can only be achieved when individually identifiable characteristics are known, could result in impact estimates that are inaccurate because these impact estimates could be due to differences between the intervention group and the comparison group and not the intervention itself. Further, while we will need to know the identifiers of beneficiaries that are the subject of the model test, the submission of other patient-level data from proprietary registries would be limited to data necessary to conduct a credible evaluation. Data on individuals are also needed to assess differential impacts among subgroups of beneficiaries to identify who benefits most from the intervention. We agree it is important to seek expert opinion on the structure of our assessment methods, and so these models are developed in concert with and run through our evaluation contractors, which are independent research firms and academic institutions. Where needed, these contractors also reach out to technical expert panels for added guidance. As a result, the design and implementation of

      Page 67754

      these assessments are informed by those with expertise in health services research, economics, statistics, program evaluation, epidemiology, and public health.

      Comment: Although generally supportive of the need for rigorous evaluations, some commenters worried that any requirement to provide individually identifiable data for monitoring and/or assessment purposes would impose an undue administrative burden on model participants, and could lead to the need to submit large (and, potentially, overbroad) amounts of individually identifiable patient-

      level data. A few commenters suggested that the Innovation Center should first look to other federal government sources before requesting data from model participants. Several commenters noted that it would be costly to produce patient-level data for models with a multi-payer focus, and others stated additional payment should be made to model participants to offset the cost of data reporting. Further, it was suggested that CMS estimate the potential burden and cost on physicians and other providers, and if found to be burdensome, give physicians the right to opt out of producing information that may not be available due to cost limitations or other administrative barriers, such as barriers to producing data stored in electronic health records.

      Response: We agree that our determination of what data are necessary to evaluate a model should be made taking into consideration the burden and cost associated with collecting and reporting such data, including the complexities associated with abstracting data from electronic health records. We further agree that in making such determinations, we should take advantage of all existing federal data systems, wherever possible so that we may minimize the amount of data that we must obtain from model participants. Our regulation will only require that model participants collect and report data as is necessary for monitoring or evaluation; thus, if we do not need the data, we would not seek to collect it from model participants.

      Reimbursement may be considered for future models, but if adopted, any such reimbursement, and any conditions for such reimbursement, would be prominently noted in the solicitation or modifications to model agreements. To the extent feasible, we also agree that it is important for potential model participants to understand the data collection requirements before the model begins, so that they may take these requirements into consideration. We do not agree, though, that model participants should be given the opportunity to opt out of producing the required information, as this would undermine the evaluation and skew results.

      With respect to the specific data needed for evaluation purposes, in many models, the evaluators will be able to determine who the individuals are that are the subjects of the model test without the need to obtain identifiers from the model participants. In those cases, there is a beneficiary-specific payment under the model and the evaluator can use our existing administrative data systems to identify which beneficiaries are in the model. In this last example, although we may not need to obtain the identifiers, we may still need to obtain other person-level data, such as clinical information. In other models, where a specific beneficiary-level payment is not being made, the evaluation contractor will not have an ability to identify the individuals targeted by the model participants. In this latter circumstance, the participants will need to provide the identifiers that would then be used by the evaluator to link to existing administrative data systems. Although the exact data needs will vary by model, in some cases we would determine that only the identifiers (such as, but not limited to, the Medicare Health Insurance Claim number) are required. In other circumstances, it is possible the evaluators will need other data, such as clinical data not otherwise available in claims to properly account for severity of disease. In this manner we will limit data demands, and the attendant costs, to the data necessary to accomplish the required monitoring and assessment.

      Comment: Some commenters stated the requirement could result in requests for data from providers tangentially involved in an Innovation Center project to report any data the agency decides it needs. A few commenters further stated the Innovation Center should ensure that all participating entities seek patient authorizations to use their records for the purpose of evaluating the model.

      Response: Section 1115A(b)(4) of the Act authorizes us to establish requirements for ``States and other entities participating in the testing of models'' to collect and report data necessary for monitoring and evaluating the models. Our regulation, therefore, establishes this requirement only with respect to model participants. We consider model participants to include any party that has agreed to participate in, or that receives payment from us under, a model we are testing. In response to the comment suggesting that the Innovation Center ensure that all participating entities seek patient authorizations to use their records for the purpose of evaluating the model, we decline to impose such a requirement in implementing section 1115A(b)(4) of the Act, and we refer such entities to their own legal counsel for advice on whether any form of consent would be required by other applicable law.

      Comment: Some commenters stated the Innovation Center should publish and be transparent about what the exact data reporting and collection requirements would be so that participants would have notice of what data they would be required to collect. Commenters stated that without a notice and comment period as part of the model test, there will be no opportunity for stakeholders to weigh in with their perspective of what constitutes the minimum necessary information to achieve the evaluation goals. A few commenters stated the Innovation Center should first determine the specific data elements that are required for evaluation purposes for the existing programs and this information should be shared with participants who should, at minimum, be given an opportunity to provide comment on the required inputs for which they will be responsible as part of the evaluation. These commenters also stated the Innovation Center should develop such requirements in advance of the program start for participants to allow them an opportunity to provide feedback and weigh the information as part of their decision to participate in the model.

      Response: We agree it is important to restrict data requests to the data necessary to conduct credible monitoring and evaluation. We frequently provide stakeholders the opportunity to weigh in on what data they believe would be necessary to evaluate a model, generally through webinars that we conduct during model development and implementation. Further, in order for potential model participants to understand the likely data reporting requirements, to the extent feasible, these requirements are incorporated into the solicitation process. However, we decline to adopt a requirement to undertake a notice and comment process as part of our determination of what data are necessary for monitoring or evaluation because we believe the process already in place allows for model participant feedback. We also disagree with commenters who recommend that we make the determination and specify the particular data elements that will be required for monitoring and evaluation prior to the start of the model. It is not

      Page 67755

      always possible at that early stage of the model to know precisely what data elements will be necessary. However, we will strive to provide as much relevant detail as possible about data collection and reporting requirements in any solicitation process and in any ongoing communications with potential participants, and we will continue to take any comments received into account in determining our data needs.

      Comment: A few commenters stated that CMS has not provided sufficient assurances that providers, in responding to these data requests, would be protected or deemed to be in compliance with the HIPAA requirements for the use and disclosure of protected health information (PHI). These commenters stated the Innovation Center reference to requiring reporting of individually identifiable patient-

      level data raises significant privacy concerns for providers who would be required to report such data. These commenters stated HIPAA requires that providers limit the use and disclosure of personal health information to the minimum necessary to accomplish the intended purpose of the disclosure. These commenters stated the Innovation Center requests for such data must be in compliance with providers' HIPAA obligations. As such, some commenters stated CMS should work with the Office for Civil Rights (OCR) to ensure providers reporting data as part of an evaluation are doing so consistent with their HIPAA obligations. These commenters stated it is HHS's Office for Civil Rights (OCR)--not CMS--that ultimately determines whether a particular provider is properly compliant and not subject to penalties. These same commenters suggested that the Innovation Center should work with OCR to issue OCR guidance stating that providers reporting data as part of an evaluation are doing so consistent with their HIPAA obligations. Some commenters stated CMS should consider the necessary data elements on a program-by-program basis rather than establishing a blanket approval, or at minimum limit the scope of the approved data requirements and uses, and should provide clear instructions and other educational resources to ensure that collection and reporting of the data complies with the HIPAA Privacy and Security rules.

      Response: We appreciate the concerns expressed about compliance with the HIPAA requirements and the recommendation to work with OCR. However, we respectfully disagree that sufficient assurances have not been provided. The disclosure would be required by a regulation, so it would be ``required by law'' under HIPAA. See 45 CFR 164.512(a) and the definition of ``required by law'' at 45 CFR 164.103. A HIPAA covered entity is permitted to disclose protected health information as required by law under these provisions so long as the disclosure complies with and is limited to the relevant requirements of the law. A separate minimum data necessary determination is not required under the HIPAA Privacy Rule for required by law disclosures under 45 CFR 164.512(a). See 45 CFR 164.502(b)(2). Although a separate minimum data necessary determination is not required, as a policy matter and consistent with the statutory authority under 1115A(b)(4), CMS will only require that data we determine is necessary for evaluation and monitoring of Innovation Center models.

      Comment: Several commenters stated that collection of beneficiary-

      level health information raises significant security concerns. Although supportive of sharing relevant and medically necessary patient information, one commenter raised a particular concern that some data could be sensitive information related to mental health or substance abuse. Some commenters stated CMS should adopt safeguards against inappropriate use or disclosure of patient identifiable data.

      Response: We agree that it is critical to abide by rigorous security standards, and we take patient privacy seriously. As CMMI is part of Fee-for-Service Medicare, a Health Care Component that is subject to the HIPAA requirements, providers' and suppliers' data will generally be subject to the same HIPAA privacy and security requirements as that data was subject to in the hands of the providers and suppliers from which it came. Furthermore, if stored in a manner searchable by individual identifiers, it will also be subject to the Privacy Act of 1974.

      As HIPAA Business Associates, this data will be equally well protected when held by one of our evaluation contractors. In addition, the disclosure of substance abuse records will, where applicable, also be subject to the Part 2 regulations.

      Comment: One commenter stated CMS should not use these data for purposes other than those articulated in the proposed rule, and that the assessments should comply with the applicable statutory requirements, meaning that: (1) The assessments should take into account all of the factors outlined under section 1115A(b)(4) of the Act (that is, quality of care, including patient-level outcomes and patient-centeredness criteria); (2) the assessments should be made publicly available; and (3) CMS should pursue notice-and-comment rulemaking before any of the CMS demonstrations are expanded based on these assessments, as required by section 1115A(c) of the Act.

      Response: We agree that evaluations should assess quality of care, and the patient-de-identified results should be made publicly available, as required by section 1115A(b)(4) of the Act. We would pursue model expansion according to the terms of the statute.

      After consideration of the public comments we received, we are finalizing our proposal to mandate the production of the individually identifiable information necessary to conduct the statutorily mandated research under section 1115A of the Act. We are accepting the recommendations made by commenters to minimize participant burden, seek input from providers, and use independent researchers. In addition, we are finalizing our proposal to add a new subpart K in part 403 to implement section 1115A of the Act without modification.

    4. Local Coverage Determination Process for Clinical Diagnostic Laboratory Testing

      The CY 2015 proposed rule (79 FR 40378 through 40380), section III.F., included discussion of a proposal to modify the existing process used by the Medicare Administrative Contractors (MACs) in developing local coverage determinations (LCDs) for clinical diagnostic laboratory tests. Briefly, the proposal would have expedited the timeline for LCD development for clinical diagnostic laboratory test LCDs by reducing the calendar days for some of the steps and by making optional or eliminating other steps within the current process. A detailed discussion of the proposal is available in section III.F. of the CY 2015 PFS Proposed Rule.

      We would like to thank the numerous public commenters for their time in submitting thoughtful comments to the agency on this issue. Comments were received from individual members of the public, insurers, drug manufacturers, medical specialty societies, laboratory groups and individual laboratories. The commenters focused their comments on the following issues: The proposal to reduce the draft LCD public comment period to 30 days; the proposal for a meeting of the Carrier Advisory Committee to be optional; the proposal to remove the requirement for a public meeting; and the proposal to eliminate the 45-day notice period prior to final

      Page 67756

      LCDs becoming effective. In addition, commenters were concerned about the proposed changes in light of section 216 of the Protecting Access to Medicare Act of 2014 (PAMA), titled ``Improving Medicare Policies for Clinical Diagnostic Laboratory Tests.'' The comments received have given the agency much to consider prior to moving forward with any changes to the LCD process; therefore, we will not finalize any changes to the LCD process in this final rule. We will explore the possibility of future notice-and-comment rulemaking on this issue.

    5. Private Contracting/Opt-Out

      1. Background

      Effective January 1, 1998, section 1802(b) of the Act permits certain physicians and practitioners to opt-out of Medicare if certain conditions are met, and to furnish through private contracts services that would otherwise be covered by Medicare. For those physicians and practitioners who opt-out of Medicare in accordance with section 1802(b) of the Act, the mandatory claims submission and limiting charge rules of section 1848(g) of the Act would not apply. As a result, if the conditions necessary for an effective opt-out are met, physicians and practitioners are permitted to privately contract with Medicare beneficiaries and to charge them without regard to Medicare's limiting charge rules. Regulations governing the requirements and procedures for private contracts appear at 42 CFR part 405, subpart D.

  51. Opt-Out Determinations (Sec. 405.450)

    The private contracting regulation at Sec. 405.450 describes certain opt-out determinations made by Medicare, and the process that physicians, practitioners, and beneficiaries may use to appeal those determinations. Section 405.450(a) describes the process available for physicians or practitioners to appeal Medicare enrollment determinations related to opting out of the program, and Sec. 405.450(b) describes the process available to challenge payment determinations related to claims for services furnished by physicians who have opted out. Both provisions refer to Sec. 405.803, the Part B claims appeals process that was in place at the time the opt-out regulations were issued (November 2, 1998). When those regulations were issued, a process for a physician or practitioner to appeal enrollment related decisions had not been implemented in regulation. Thus, to ensure an appeals process was available to physicians and practitioners for opt-out related issues, we chose to utilize the existing claims appeals process in Sec. 405.803 for both enrollment and claims related appeals.

    In May 16, 2012 Federal Register (77 FR 29002), we published a final rule entitled ``Medicare and Medicaid Program; Regulatory Provisions to Promote Program Efficiency, Transparency and Burden Reduction.'' In that final rule, we deleted the provisions relating to initial determinations, appeals, and reopenings of Medicare Part A and Part B claims, and relating to determinations and appeals regarding an individual's entitlement to benefits under Medicare Part A and Part B, which were contained in part 405, subparts G and H (including Sec. 405.803) because these provisions were obsolete and had been replaced by the regulations at part 405, subpart I. We inadvertently neglected to revise the cross-reference in Sec. 405.450(a) and (b) of the private contracting regulations to direct appeals of opt-out determinations through the current appeal process. However, it is important to note that our policy regarding the appeal of opt-out determinations did not change when the appeal regulations at part 405, subpart I were finalized.

    The procedures set forth in current part 498 establish the appeals procedures regarding decisions made by Medicare that affect enrollment in the program. We believe this process, and not the appeal process in part 405, subpart I, is the appropriate channel for physicians and practitioners to challenge an enrollment related opt-out decision made by Medicare. There are now two different sets of appeal regulations for initial determinations; and the appeal of enrollment related opt-out determinations is more like the types of determinations now addressed under part 498 than those under part 405, subpart I. Specifically, the appeal process under part 405, subpart I focuses on reviews of determinations regarding beneficiary entitlement to Medicare and claims for benefits for particular services. The appeal process under part 498 is focused on the review of determinations regarding the participation or enrollment status of providers and suppliers. Enrollment related opt-out determinations involve only the status of particular physician or practitioners under Medicare, and do not involve beneficiary eligibility or claims for specific services. As such, the appeal process under part 498 is better suited for the review of enrollment related opt-out determinations.

    However, we do not believe the enrollment appeals process established in part 498 is the appropriate mechanism for challenging payment decisions on claims for services furnished by a physician and practitioner who has opted out of the program. Appeals for such claims should continue to follow the appeals procedures now set forth in part 405 subpart I.

  52. Definitions, Requirements of the Opt Out Affidavit, Effects of Opting Out of Medicare, Application to Medicare Advantage Contracts (Sec. Sec. 405.400, 405.420(e), 405.425(a), and 405.455)

    Section 405.400 sets forth certain definitions for purposes of the private contracting regulations. Among the defined terms is ``Emergency care services'' which means services furnished to an individual for treatment of an ``emergency medical condition'' as that term is defined in Sec. 422.2. The cross-referenced regulation at Sec. 422.2 included within the definition of emergency care services was deleted on June 29, 2000 (65 FR 40314) and at that time we inadvertently neglected to revise that cross-reference. The cross-reference within the definition of emergency care services should have been amended at that time to cite the definition of ``emergency services'' in Sec. 424.101.

    The private contracting regulations at Sec. 405.420(e), Sec. 405.425(a) and Sec. 405.455 all use the term Medicare Choice when referring to Part C plans. However, we no longer use the term Medicare Choice when referring to Part C plans; instead the plans are referred to as Medicare Advantage plans. When part 422 of the regulations was updated on January 28, 2005 (70 FR 4741), we inadvertently neglected to revise Sec. 405.420(e), Sec. 405.425(a) and Sec. 405.455 to replace the term Medicare Choice with Medicare Advantage plan.

    2. Provisions of the Proposed Regulation

    For the reasons discussed above, we proposed that a determination described in Sec. 405.450(a) (relating to the status of opt-out or private contracts) is an initial determination for purposes of Sec. 498.3(b), and a physician or practitioner who is dissatisfied with a Medicare determination under Sec. 405.450(a) may utilize the enrollment appeals process currently available for providers and suppliers in part 498. In addition, we proposed that a determination described in Sec. 405.450(b) (that payment cannot be made to a beneficiary for services furnished by a physician or practitioner who has opted out) is an initial determination for the purposes of Sec. 405.924 and may be challenged through the existing claims appeals procedures in part 405 subpart I. Accordingly, we proposed that the cross

    Page 67757

    reference to Sec. 405.803 in Sec. 405.450(a) be replaced with a cross reference to Sec. 498.3(b). We also proposed that the cross reference to Sec. 405.803 in Sec. 405.450(b) be replaced with a cross reference to Sec. 405.924. We also proposed corresponding edits to Sec. 498.3(b) and Sec. 405.924 to note that the determinations under Sec. 405.450(a) and (b), respectively, are initial determinations.

    For the reasons discussed above, we also proposed that the definition of Emergency care services at Sec. 405.400 be revised to cite the definition of Emergency services in Sec. 424.101 and that all references to Medicare Choice in Sec. 405.420(e), Sec. 405.425(a) and Sec. 405.455 be replaced with the term ``Medicare Advantage.''

    The following is a summary of the comments we received regarding our proposals.

    Comment: Commenters requested that physicians and practitioners be allowed to opt out of Medicare indefinitely instead of submitting a new affidavit every 2 years.

    Response: These comments are outside the scope of this rule as they are not related to the proposed changes to the opt-out regulations. Nevertheless, we note that section 1802(b)(3)(B)(ii) of the Act specifies that the opt-out affidavit must provide that the ``physician or practitioner will not submit any claim under this title for any item or service provided to any medicare beneficiary. . . during the 2-year period beginning on the date the affidavit is signed.'' As such, the longest interval for which an opt-out can be effective is 2 years. We have no authority to modify that statutory requirement.

    Because we did not receive any comments on our proposals, we are finalizing the rule as proposed.

    1. Solicitation of Comments on the Payment Policy for Substitute Physician Billing Arrangements

      1. Background

      In accordance with section 1842(b)(6) of the Act, no payment under Medicare Part B may be made to anyone other than to the beneficiary to whom a service was furnished or to the physician or other person who furnished the service. However, there are certain limited exceptions to this general prohibition. For example, section 1842(b)(6)(D) of the Act describes an exception for substitute physician billing arrangements, which states that ``payment may be made to a physician for physicians' services (and services furnished incident to such services) furnished by a second physician to patients of the first physician if (i) the first physician is unavailable to provide the services; (ii) the services are furnished pursuant to an arrangement between the two physicians that (I) is informal and reciprocal, or (II) involves per diem or other fee-for-time compensation for such services; (iii) the services are not provided by the second physician over a continuous period of more than 60 days or are provided over a longer continuous period during all of which the first physician has been called or ordered to active duty as a member of a reserve component of the Armed Forces; and (iv) the claim form submitted to the Medicare Administrative contractor (MAC) for such services includes the second physician's unique identifier . . . and indicates that the claim meets the requirements of this subparagraph for payment to the first physician.'' Section 1842(b)(6) of the Act is self-implementing and we have not interpreted the statutory provisions through regulations.

      In practice, section 1842(b)(6)(D) of the Act generally allows for two types of substitute physician billing arrangements: (1) An informal reciprocal arrangement where doctor A substitutes for doctor B on an occasional basis and doctor B substitutes for doctor A on an occasional basis; and (2) an arrangement where the services of the substitute physician are paid for on a per diem basis or according to the amount of time worked. Substitute physicians in the second type of arrangement are sometimes referred to as ``locum tenens'' physicians. It is our understanding that locum tenens physicians are substitute physicians who often do not have a practice of their own, are geographically mobile, and work on an as-needed basis as independent contractors. They are utilized by physician practices, hospitals, and health care entities enrolled in Part B as Medicare suppliers to cover for physicians who are absent for reasons such as illness, pregnancy, vacation, or continuing medical education. Also, we have heard anecdotally that locum tenens physicians are used to fill staffing needs (for example, in physician shortage areas) or, on a temporary basis, to replace physicians who have permanently left a medical group or employer.

      We are concerned about the operational and program integrity issues that result from the use of substitute physicians to fill staffing needs or to replace a physician who has permanently left a medical group or employer. For example, although our Medicare enrollment rules require physicians and physician groups or organizations to notify us promptly of any enrollment changes (including reassignment changes) (see Sec. 424.516(d)), processing delays or miscommunication between the departing physician and his or her former medical group or employer regarding which party would report the change to Medicare could result in the Provider Transaction Access Number (PTAN) that links the departed physician and his or her former medical group remaining ``open'' or ``attached'' for a period of time. During such period, both the departed physician and the departed physician's former medical group might bill Medicare under the departed physician's National Provider Identifier (NPI) for furnished services. This could occur where a substitute physician is furnishing services in place of the departed physician in the departed physician's former medical group, while the departed physician is also furnishing services to beneficiaries following departure from the former group. Operationally, either or both types of claims could be rejected or denied, even though the claims filed by the departed physician were billed appropriately. Moreover, the continued use of a departed physician's NPI to bill for services furnished to beneficiaries by a substitute physician raises program integrity issues, particularly if the departed physician is unaware of his or her former medical group or employer's actions.

      Finally, as noted above, section 1842(b)(6)(D)(iv) of the Act requires that the claim form submitted to the MAC include the substitute physician's unique identifier. Currently, the unique identifier used to identify a physician is the physician's NPI. Prior to the implementation of the NPI, the Unique Physician Identification Number (UPIN) was used. Because a substitute physician's NPI is not captured on the CMS-1500 claim form or on the appropriate electronic claim, physicians and other entities that furnish services to beneficiaries through the use of a substitute physician are required to enter a modifier on the CMS-1500 claim form or on the appropriate electronic claim indicating that the services were furnished by a substitute physician; and to keep a record of each service provided by the substitute physician, associated with the substitute physician's UPIN or NPI; and to make this record available to the MAC upon request. (See Medicare Claims

      Page 67758

      Processing Manual (Pub. 100-4), Chapter 1, Sections 30.2.10 and 30.2.11) However, having a NPI or UPIN does not necessarily mean that the substitute physician is enrolled in the Medicare program. Without being enrolled in Medicare, we do not know whether the substitute physician has the proper credentials to furnish the services being billed under section 1842(b)(6)(D) of the Act or if the substitute physician is sanctioned or excluded from Medicare. The importance of enrollment and the resulting transparency afforded the Medicare program and its beneficiaries was recognized by the Congress when it included in the Affordable Care Act a requirement that physicians and other eligible non-physician practitioners (NPPs) enroll in the Medicare program if they wish to order or refer certain items or services for Medicare beneficiaries. This includes those physicians and other eligible NPPs who do not and will not submit claims to a Medicare contractor for the services they furnish. We solicited comments regarding how to achieve similar transparency in the context of substitute physician billing arrangements for the identity of the individual actually furnishing the service to a beneficiary.

      2. Analysis of Comments

      To help inform our decision whether and, if so, how to address the issues discussed in section III.H.1., and whether to adopt regulations interpreting section 1842(b)(6)(D) of the Act, we solicited comments on the policy for substitute physician billing arrangements. We noted that any regulations would be proposed in a future rulemaking with opportunity for public comment. Through this solicitation, we hoped to understand better current industry practices for the use of substitute physicians and the impact that policy changes limiting the use of substitute physicians might have on beneficiary access to physician services.

      We received a few comments on the issues raised in this solicitation. We thank the commenters for their input, and we will carefully consider their comments in any future rulemaking on this subject.

      I. Reports of Payments or Other Transfers of Value to Covered Recipients

      1. Background

      In the February 8, 2013 Federal Register (78 FR 9458), we published the ``Transparency Reports and Reporting of Physician Ownership or Investment Interests'' final rule which implemented section 1128G of the Social Security Act (``Act''), as added by section 6002 of the Affordable Care Act. Under section 1128G(a)(1) of the Act, manufacturers of covered drugs, devices, biologicals, and medical supplies (applicable manufacturers) are required to submit on an annual basis information about certain payments or other transfers of value made to physicians and teaching hospitals (collectively called covered recipients) during the course of the preceding calendar year. Section 1128G(a)(2) of the Act requires applicable manufacturers and applicable group purchasing organizations (GPOs) to disclose any ownership or investment interests in such entities held by physicians or their immediate family members, as well as information on any payments or other transfers of value provided to such physician owners or investors. The implementing regulations are at 42 CFR part 402, subpart A, and part 403, subpart I. We have organized these reporting requirements under the ``Open Payments'' program.

      The Open Payments program creates transparency around the nature and extent of relationships that exist between drug, device, biologicals and medical supply manufacturers, and physicians and teaching hospitals (covered recipients and physician owner or investors). The implementing regulations, which describe procedures for applicable manufacturers and applicable GPOs to submit electronic reports detailing payments or other transfers of value and ownership or investment interests provided to covered recipients and physician owners or investors, are codified at Sec. 403.908.

      Since the publication and implementation of the February 8, 2013 final rule, various stakeholders have provided feedback to CMS regarding certain aspects of these reporting requirements. Specifically, Sec. 403.904(g)(1) excludes the reporting of payments associated with certain continuing education events, and Sec. 403.904(c)(8) requires reporting of the marketed name for drugs and biologicals but makes reporting the marketed name of devices or medical supplies optional. We proposed a change to Sec. 403.904(g) to correct an unintended consequence of the current regulatory text. Additionally, at Sec. 403.904(c)(8), we proposed to make the reporting requirements consistent by requiring the reporting of the marketed name for drugs, devices, biologicals, or medical supplies which are associated with a payment or other transfer of value.

      Additionally, at Sec. 403.902, we proposed to remove the definition of a ``covered device'' because we believe it is duplicative of the definition of ``covered drug, device, biological or medical supply'' which is codified in the same section. We also proposed to require the reporting of the following distinct forms of payment: stock; stock option; or any other ownership interests specified in Sec. 403.904(d)(3) to collect more specific data regarding the forms of payment.

      2. Continuing Education Exclusion (Sec. 403.904(g)(1))

      In the February 8, 2013 final rule, many commenters recommended that accredited or certified continuing education payments to speakers should not be reported because there are safeguards already in place, and they are not direct payments to a covered recipient. In the final rule preamble, we noted that ``industry support for accredited or certified continuing education is a unique relationship'' (78 FR 9492). Section 403.904(g)(1) states that payments or other transfers of value provided as compensation for speaking at a continuing education program need not be reported if the following three conditions are met:

      The event at which the covered recipient is speaking must meet the accreditation or certification requirements and standards for continuing education for one of the following organizations: the Accreditation Council for Continuing Medical Education (ACCME); the American Academy of Family Physicians (AAFP); the American Dental Association's Continuing Education Recognition Program (ADA CERP); the American Medical Association (AMA); or the American Osteopathic Association (AOA).

      The applicable manufacturer does not pay the covered recipient speaker directly.

      The applicable manufacturer does not select the covered recipient speaker or provide the third party (such as a continuing education vendor) with a distinct, identifiable set of individuals to be considered as speakers for the continuing education program.

      Since the implementation of Sec. 403.904(g)(1), other accrediting organizations have requested that payments made to speakers at their events also be exempted from reporting. These organizations have stated that they follow the same accreditation standards as the organizations specified in Sec. 403.904(g)(1)(i). Other stakeholders have recommended that the exemption be removed in its entirety stating

      Page 67759

      removal of the exclusion will allow for consistent reporting for compensation provided to physician speakers at all continuing education events, as well as transparency regarding compensation paid to physician speakers. Many stakeholders raised concerns that the reporting requirements are inconsistent because certain continuing education payments are reportable, while others are not. CMS' apparent endorsement or support to organizations sponsoring continuing education events was an unintended consequence of the final rule.

      After consideration of these comments, we proposed to remove the language in Sec. 403.904(g) in its entirety, in part because it is redundant with the exclusion in Sec. 403.904(i)(1). That provision excludes indirect payments or other transfers of value where the applicable manufacturer is ``unaware'' of, that is, ``does not know,'' the identity of the covered recipient during the reporting year or by the end of the second quarter of the following reporting year. When an applicable manufacturer or applicable GPO provides funding to a continuing education provider, but does not either select or pay the covered recipient speaker directly, or provide the continuing education provider with a distinct, identifiable set of covered recipients to be considered as speakers for the continuing education program, CMS will consider those payments to be excluded from reporting under Sec. 403.904(i)(1). This approach is consistent with our discussion in the preamble to the final rule, in which we explained that if an applicable manufacturer conveys ``full discretion'' to the continuing education provider, those payments are outside the scope of the rule (78 FR 9492). In contrast, for example, when an applicable manufacturer conditions its financial sponsorship of a continuing education event on the participation of particular covered recipients, or pays a covered recipient directly for speaking at such an event, those payments are subject to disclosure.

      We considered two alternative approaches to address this issue. First, we explored expanding the list of organizations in Sec. 403.904(g)(1)(i) by name; however, we believe that this approach might imply CMS's endorsement of the named continuing education providers over others. Second, we considered expansion of the organizations in Sec. 403.904(g)(1)(i) by articulating accreditation or certification standards that would allow a CME program to qualify for the exclusion. This approach is not easily implemented because it would require evaluating both the language of the standards, as well as the enforcement of the standards of any organization professing to meet the criteria. We solicited comments on both alternatives presented, including commenters' suggestions about what standards, if any, CMS should incorporate.

      The following is summary of the comments we received regarding both alternatives presented, and what standards, if any, CMS should incorporate.

      Comment: We received numerous comments addressing our proposal to remove the exclusion for compensation for speaking at a continuing education program. Some comments were in support to remove the exclusion stating it is an important step toward ensuring transparency. Supporting comments also agreed removing the exclusion will level the playing field with the medical education community. Numerous commenters questioned our proposal to remove the exclusion for compensation for speaking at a continuing education program. Commenters provided background regarding accrediting continuing education organizations stating that creating continuing education accreditation standards is a function of professional self-regulation and additional government regulation is not necessary.

      Many commenters recommend modifying the indirect payment exclusion currently at Sec. 403.904(i)(1) to specify a continuing education indirect payment should be excluded if the manufacturer did not know the identity of the covered recipient before providing the payment to a third party, such as a continuing education organization. This differs from the current indirect payment exclusion language which states the payment is excluded if the manufacturer did not know the identity of the covered recipient during the reporting year or by the end of the second quarter of the following reporting year. Commenters stated it is not practical for a manufacturer to not know the identity of a physician speaker receiving compensation for speaking at a continuing education event during the reporting year or by the end of the second quarter of the following reporting year because manufacturers could learn the identities of physician speakers through brochures, programs and other publications. Therefore, commenters assert that the indirect payment exclusion is not applicable to exclude compensation provided to physicians at a continuing education event and recommend the indirect payment exclusion is modified to accommodate indirect payments provided to a physician covered recipient through a continuing medical education organization.

      Additionally, commenters suggested an alternative approach where CMS would adopt established criteria, such as the Standards for Commercial Support: Standards to Ensure Independence in CME Activities, in order to have payments provided to physicians at continuing education events excluded. Similar criteria suggested by commenters to modify the exclusion were: does not pay covered speakers or attendees directly, does not select covered recipient speakers or provide a third party with a distinct, identifiable set of individuals to be considered as speakers or attendees for the continuing education program, and does not control the continuing education program content.

      Response: We appreciate commenters support to remove the exclusion for compensation for speaking at a continuing education program. We appreciate the comments stating that continuing medical education accrediting organizations is a function of professional self-

      regulation. We believe creating consistent reporting requirements for all continuing education events, by removing the language in Sec. 403.904(g) in its entirety, will provide enhanced regulatory clarity for stakeholders. Manufacturers reporting compensation paid to physician speakers may opt to distinguish if the payment was provided at an accredited or certified continuing education program versus an unaccredited or non-certified continuing education program by selecting the appropriate nature of payment category at Sec. 403.904(e).

      We understand commenters concern regarding learning the identity of the physician during the reporting year or by the end of the second quarter of the following reporting year. In the situation of an applicable manufacturer providing an indirect payment through a continuing education organization and learning the identity of the physician covered recipient in the allotted timeframe (during the reporting year or by the end of the second quarter of the following reporting year) the indirect payment would not meet the criteria of the indirect payment exclusion and would need to be reported. However, payments or other transfers of value, including payments made to physician covered recipients for purposes of attending or speaking at continuing education events, which do not meet the definition of an indirect payment, as

      Page 67760

      defined at Sec. 403.902, are not reportable. For example, if an applicable manufacturer or applicable GPO provides funding to support a continuing education event but does not require, instruct, direct, or otherwise cause the continuing education event provider to provide the payment or other transfer or value in whole or in part to a covered recipient, the applicable manufacturer or applicable GPO is not required to report the payment or other transfer of value. The payment is not reportable regardless if the applicable manufacturer or applicable GPO learns the identity of the covered recipient during the reporting year or by the end of the second quarter of the following reporting year because the payment or other transfer of value did not meet the definition of an indirect payment. This approach is also consistent with our statement at (78 FR 9490), where we explained that ``if an applicable manufacturer provided an unrestricted donation to a physician professional organization to use at the organization's discretion, and the organization chose to use the donation to make grants to physicians, those grants would not constitute `indirect payments' because the applicable manufacturer did not require, instruct, or direct the organization to use the donation for grants to physicians.'' Therefore, because such payments are not indirect payments, we do not need to create an additional exclusion specific to continuing education indirect payments by modifying the indirect payment exclusion at Sec. 403.904(i)(1).

      Comment: Many commenters interpreted the removal of physician speaker compensation at continuing education events would also remove the reporting exclusion for attendees at accredited or certified continuing education events whose fees have been subsidized through the continuing medical education organization by an applicable manufacturers.

      Response: We did not intend to remove the exclusion regarding subsidized fees provided to physician attendees by manufacturers at continuing education events. However, we intend for physician speaker compensation and physician attendees fees which have been subsidized through the continuing medical education organization by an applicable manufacturer to be reported unless the payment meets the indirect payment exclusion at Sec. 403.904(i)(1). This allows for consistent reporting for physician attendees and speakers at continuing education events. We will provide sub-regulatory guidance specifying tuition fees provided to physician attendees that have been generally subsidized at continuing education events by manufacturers are not expected to be reported. However, if a manufacturer does instruct, direct, or otherwise cause the subsidized tuition fee for a continuing education event to go to a specific physician attendee, the payment will not be excluded, since the indirect payment exclusion only applies if the manufacturer did not know the identity of the physician attendee.

      Comment: Many commenters interpreted the proposed removal ofSec. 403.904(g) to expand the exclusion to account for continuing education programs accredited or certified for nurses, optometrists, pharmacists, and others.

      Response: We appreciate the comments, but the removal ofSec. 403.904(g) was not intended to expand the exclusion. The intent is to allow for consistent reporting for compensation provided to physician speakers at all continuing education events, as well as transparency regarding compensation paid to physician speakers.

      Comment: A few commenters requested CMS provide clear and realistic timeframes regarding payments related to continuing education events to allow manufacturers to provide sponsor notice as it considers proposals to eliminate the current CME exclusion.

      Response: We agree with commenters that manufacturers may need additional time to comply with reporting requirements; therefore, we are finalizing data collection requirements that would begin January 1, 2016 according to this final rule for applicable manufacturers.

      3. Reporting of Marketed Name (Sec. 403.904(c)(8))

      Section 1128G(a)(1)(A)(vii) of the Act requires applicable manufacturers to report the name of the covered drug, device, biological or medical supply associated with that payment, if the payment is related to ``marketing, education, or research'' of a particular covered drug, device, biological, or medical supply. Section 403.904(c)(8)(i) requires applicable manufacturers to report the marketed name for each drug or biological related to a payment or other transfer of value. At Sec. 403.904(c)(8)(ii), we require an applicable manufacturer of devices or medical supplies to report one of the following: the marketed name; product category; or therapeutic area. In the February 8, 2013, final rule, we provided applicable manufactures with flexibility when it was determined that the marketed name for all devices and medical supplies may not be useful for the general audience. We did not define product categories or therapeutic areas in Sec. 403.904(c). However, since implementation of the February 8, 2013 final rule and the development of the Open Payments system, we have determined that aligning the reporting requirements for marketed name across drugs, biologics, devices and medical supplies will make the data fields consistent within the system, and also enhance consumer's use of the data.

      Accordingly, we proposed to revise Sec. 403.904(c)(8) to require applicable manufacturers to report the marketed name for all covered drugs, devices, biologicals or medical supplies. We believe this would facilitate consistent reporting for the consumers and researchers using the data displayed publicly on the Open Payments. Manufacturers would still have the option to report product category or therapeutic area, in addition to reporting the market name, for devices and medical supplies.

      Comment: We received a few comments regarding revising reporting requirements at Sec. 403.904(c)(8). These comments mainly stated that the marketed name for a device or medical supply is not useful for the public because the public is not familiar with device or medical supply marketed names. We also received a few comments that supported requiring the reporting of marketed name for devices and medical supplies. Supporting commenters believe that reporting marketed name for all products will allow the public (including researchers and consumers) to search the data via the Open Payments public Web site for a specific device or medical supply. Commenters also stated that reporting marketed name for non-covered products is not required by the statute and therefore manufacturers should not be required to report marketed names for non-covered products. Additionally, some comments indicated reporting marketed name for devices and medical supplies for research payments is not practical because there is not a marketed name for every device or medical supply associated with research payments; rather there may only be a connection to an associated research study. A few commenters addressed that manufacturers will have an increased burden to modify reporting systems to accommodate reporting marketed name for devices and medical supplies.

      Response: We appreciate the comments supporting our proposed revisions requiring reporting marketed name for devices and medical supplies.

      Page 67761

      We have finalized a modified approach to accommodate concerns regarding reporting related covered drug, device, biological or medical supply information. We agree manufacturers should not be required to report marketed names for non-covered products; therefore, we are finalizing the proposal that reporting marketed names for non-covered drugs, devices, biologicals, or medical supplies will continue to be optional. We also agree a payment or other transfer of value associated with a research payment regarding a device or medical supply may not have a marketed name. Therefore, we are finalizing the proposal that manufacturers will continue to have an option to report either a device or medical supply marketed name, therapeutic area or product category when reporting research payments.

      After consideration of comments received, we agree that displaying therapeutic areas or product categories are useful for the public reviewing data on the Open Payments public Web site because the public is not familiar with marketed names for devices and medical supplies. We agree therapeutic areas and products categories are more recognizable by the public. Yet, reporting marketed names for all covered products is necessary to achieve consistent reporting and to have the ability to aggregate all payments or other transfers of value associated with a specific device or medical supply. Therefore to achieve consistent reporting by manufacturers, we will require manufacturers to report marketed name and therapeutic area or product category for all covered drugs, devices, biologicals or medical supplies. We also agree with commenters that complying with this reporting requirement will require a change in manufacturers' reporting systems; therefore, data collection for this reporting requirement would begin January 1, 2016.

      4. Reporting of Stock, Stock Option, or Any Other Ownership Interest

      Section 403.904(d)(3) requires the reporting of stock, stock option, or any other ownership interest. We proposed to require applicable manufacturers to report such payments as distinct categories. This will enable us to collect more specific data regarding the forms of payment made by applicable manufacturers. After issuing the February 8, 2013 final rule and the development of the Open Payments system, we determined that this specificity will increase the ease of data aggregation within the system, and also enhance consumer's use of the data. We solicited comments on the extent to which users of this data set find this disaggregation to be useful, and whether this change presents operational or other issues on the part of applicable manufacturers.

      The following is summary of the comments we received regarding the extent to which users of this data set find this disaggregation to be useful, requiring reporting of marketed name for covered devices and medical supplies, and whether this change presents operational or other issues on the part of applicable manufacturers.

      Comment: Commenters agreed that requiring reporting of stock, stock option or any other ownership interest in distinct categories is useful.

      Response: We agree the disaggregation of reporting stock, stock option or any other ownership interest in distinct categories. Therefore, we have finalized this provision as proposed, which requires reporting stock, stock option, or any other ownership interest form of payment or other transfer of value in distinct categories.

    2. Physician Compare Web Site

      1. Background and Statutory Authority

      Section 10331(a)(1) of the Affordable Care Act, requires that, by no later than January 1, 2011, we develop 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.

      CMS 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.

      Section 10331(a)(2) of the Affordable Care Act also requires that, no later than January 1, 2013, and for reporting periods that began no earlier than January 1, 2012, we implement a plan for making publicly available through Physician Compare information on physician performance that provides comparable information on quality and patient experience measures. We met this requirement in advance 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).

      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.

      As required under section 10331(b) of the Affordable Care Act, in developing and implementing the plan, we must 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 eligible professionals 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 and 78 FR 74450). 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

      Page 67762

      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.). In developing the plan for making information on physician performance publicly available through Physician Compare, section 10331(e) of the Affordable Care Act requires the Secretary, as the Secretary determines appropriate, to consider the plan to transition to value-based purchasing for physicians and other practitioners that was developed under section 131(d) of the MIPPA.

      Under section 10331(f) of the Affordable Care Act, we are required to submit a report to the Congress by January 1, 2015, on Physician Compare development, and include 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. Section 10331(g) of the Affordable Care Act provides that any time before that date, we may continue to expand the information made available on Physician Compare.

      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 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. On June 27, 2013, we launched a full redesign of Physician Compare bringing significant improvements including a complete overhaul of the underlying database and a new Intelligent Search feature, addressing two of our stakeholders' primary critiques of the site--the accuracy and currency of the database and the limitations of the search function--and considerably improving Web site functionality and usability. Provider Enrollment, Chain, and Ownership System (PECOS), as the sole source of verified Medicare professional information, is the primary source of administrative information on Physician Compare. With the redesign, however, we incorporated the use of Medicare Fee-For-Service claims information to verify the information in PECOS to help ensure only the most current and accurate information is included on the site. For example, claims information is used to determine which of the active and approved practice locations in PECOS are where the professional is currently providing services. Claims information helps confirm that only the most current group practice affiliations are included on the site. Our use of claims also helps ensure that we are posting on Physician Compare the most current and accurate information available about the professionals for Medicare consumers.

      We received several comments about the enhancements made to the Physician Compare Web site and the data currently on the Web site.

      Comment: Several commenters noted the improvements made to the Physician Compare Web site, including the additional labeling, improvements to the ``Is this you?'' link, the reordering of the search results, the Intelligent Search functionality, the use of claims data to verify professionals' demographic information, denoting board certified physicians with contextual text, and explanations and disclaimers about each of the federal quality reporting programs included on the Web site. Commenters also noted an appreciation for the transparency and easy-to-use, comprehensive information available on the site to aid consumers in making informed health care decisions.

      Some commenters provided suggestions for future Physician Compare enhancements. A few commenters suggested continued improvements to the Intelligent Search functionality to better find health care professionals other than physicians and additional specialty labels for Advanced Practice Registered Nurses (APRNs) and allied health professionals.

      Response: We appreciate the commenters' feedback and the continued support for the Physician Compare Web site. We are committed to continuing to improve the site and its functionality to ensure it is a useful resource for Medicare consumers, including information that can help these consumers make informed health care decisions. We also appreciate the recommendations regarding other health care professionals, and we will evaluate these recommendations for potential future inclusion. Also, we are continually working to improve and enhance the Intelligent Search functionality.

      Comment: Some commenters expressed concerns about the accuracy of data such as demographic information, specialty classification, and hospital affiliation. Several commenters urged CMS to address these concerns prior to posting additional quality measure performance information on the Web site. Other commenters requested we implement a streamlined process by which professionals can confirm or correct their information in a timely manner. One commenter urged CMS to ensure that updates made in PECOS are reflected on Physician Compare within 30 days, while another commenter cautioned against using PECOS for updating information. Several commenters suggested continuing to work with stakeholders, particularly health care professionals, and/or providing educational material regarding how to keep data current to ensure the accuracy of the Web site.

      Response: We appreciate the commenters' feedback regarding concerns over the accuracy of the information currently available on Physician Compare. We are committed to including accurate and up-to-date information on Physician Compare and continue to work to make improvements to the information presented.

      The underlying database on Physician Compare is generated from PECOS, as well as Fee-For-Service (FFS) claims, and it is therefore critical that physicians, other health care professionals, and group practices ensure that their information is up-to-date and as complete as possible in the national PECOS database. Currently, the most immediate way to address inaccurate PECOS data on Physician Compare is by updating information via Internet-based PECOS at https://pecos.cms.hhs.gov/pecos/login.do. Please note that the specialties as reported on Physician Compare are those specialties reported to Medicare when a physician or other health care professional enrolls in Medicare and are limited to the specialties noted on the 855i Enrollment Form. All addresses listed on Physician Compare must be entered in and verified in PECOS.

      Page 67763

      There is a lag between when an edit is made in PECOS and when that edit is processed by the Medicare Administrative Contractor (MAC) and available in the PECOS data pulled for Physician Compare. This time is necessary for data verification but unfortunately results in a delay updating information. We are continually working to find ways to minimize this delay.

      To update information not found in PECOS, such as hospital affiliation and foreign language, professionals and group practices should contact the Physician Compare support team directly at PhysicianCompare@Westat.com. Information regarding how to keep your information current can also be found on the Physician Compare Initiative page on CMS.gov (http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/physician-compare-initiative/).

      Although we appreciate the concerns raised around the PECOS data included on Physician Compare, it is necessary to continue the use of the PECOS data as it is the sole, verified source of Medicare information. However, we are aware of its limitations. For these reasons, we have instituted the use of claims information and are continuing to work to find ways to further improve the data. The data are significantly better today than they were prior to the 2013 redesign and continues to improve. We strongly encourage all professionals and group practices listed on the site to regularly check their data and to contact the support team with any questions or concerns.

      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, languages spoken, and American Board of Medical Specialties (ABMS) board certification information. In addition, for group practices, users can also view group practice names, specialties, practice locations, Medicare assignment status, and affiliated professionals.

      We post on the Web site the names of individual EPs who satisfactorily report under PQRS, as well as those EPs who are successful electronic prescribers under the Medicare Electronic Prescribing (eRx) Incentive Program. Physician Compare contains a link to a downloadable database of all information on Physician Compare (https://data.medicare.gov/data/physician-compare), including information on this quality program participation. 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. We proposed (79 FR 40386) to continue to include this information annually in the year following the year it is reported (for example, 2015 PQRS reporting will be included on the Web site in 2016). We did not receive any comments on this proposal. We are finalizing this proposal at this time, and therefore, will include satisfactory 2015 PQRS reporters on the Web site in 2016. The eRx Incentive Program ends in 2014 so those data will not be available in 2015 or beyond.

      With the Physician Compare redesign, we added a quality programs section to each group practice profile page in order to indicate which group practices are satisfactorily reporting in the Group Practice Reporting Option (GPRO) under PQRS or are successful electronic prescribers under the eRx Incentive Program. We have also included a notation and check mark for individuals that successfully participate in the Medicare EHR Incentive Program, as authorized by section 1848(o)(3)(D) of the Act. We proposed (79 FR 40386) to continue to include this information annually in the year following the year it is reported (for example, 2015 data will be included on the Web site in 2016).

      We did not receive any comments regarding our proposal regarding this PQRS GPRO. We are finalizing the proposal to include a notation for satisfactory PQRS GPRO reporters. As noted above, the eRx Incentive Program is ending in 2014, and therefore, there will not be data for this program in 2015 or beyond. We did receive comments regarding including a notation for individuals that successfully participate in the Medicare EHR Incentive Program.

      Comment: Two commenters urged CMS to reconsider its decision to publicly report participation in the Medicare EHR Incentive Program due to ongoing issues related to the program--including unresolved challenges related to vendor certification delays, concerns about the relevancy to consumers, and limited ability to implement core measures. One commenter suggested including a disclaimer next to the indicator explaining these barriers and clarifying that successful participation in the EHR Incentive Program is only one of various ways to demonstrate an investment in higher quality care.

      Response: We appreciate the commenters' feedback, and we will take the suggestions provided regarding a disclaimer into consideration for possible future enhancements. We also appreciate the concerns raised about the program, specifically around vendor certification and core measures. However, despite those potential limitations, a number of professionals and groups are successfully taking part at this time and we believe it is important to continue to recognize them. Also, consumers find this information interesting and helpful. This is only one of multiple quality programs included on Physician Compare that we find important to highlight. As a result, we are going to finalize our proposal to continue including an indicator for participation in the EHR Incentive Program on the Web site.

      We previously finalized a decision to publicly report the names of those EPs who report the 2014 PQRS Cardiovascular Prevention measures group in support of Million Hearts on Physician Compare in 2015, by including a check mark in the quality programs section of the profile page (78 FR 74450). We proposed (79 FR 40386) to also continue to include this information annually in the year following the year it is reported (for example, 2015 data will be included on Physician Compare in 2016).

      Comment: Some commenters supported our proposal to publicly report and include an indicator for EPs who report the 2015 PQRS Cardiovascular Prevention measures group in support of Million Hearts. Commenters noted that Million Hearts is an important initiative for supporting cardiovascular health.

      Response: We appreciate the commenters' support. We agree that Million Hearts is an important initiative that is improving outcomes for cardiovascular health. However, we are finalizing the removal of the Cardiovascular Prevention measure group from the PQRS program given that the two cholesterol control measures included in the measure group are no longer clinically relevant, and therefore, the measure group no longer meets the necessary threshold for PQRS of six measures and will no longer be available for reporting under the program. With the removal of the 2 cholesterol control measures, the remaining measures from the original Cardiovascular Prevention measure group are:

      Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antithrombotic.

      Preventive Care and Screening: Tobacco Use.

      Page 67764

      Controlling High Blood Pressure.

      Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented.

      All of these measures are available as individual measures under PQRS. Given that the Cardiovascular Prevention measure group is being eliminated from the PQRS, but that the remaining measures identified above will be available for individual reporting, we are modifying our final policy with regard to our proposal to support Million Hearts on Physician Compare. Specifically, we are finalizing that any EP that satisfactorily reports all four of the individual measures noted above will receive a green check mark indicating support for Million Hearts. A key strategy of the Million Hearts initiative is to reduce the number of heart attacks and strokes, and the program has found that reporting these quality measures is a first step toward performance improvement. We are committed to supporting this initiative, and even though the measure group is no longer available under PQRS, we think it is important to continue recognizing those individual EPs who are reporting these quality measures as individual measures. Even though the individual measures require that a potentially higher number of patients are reported on--50 percent of patients that meet the sample requirements versus just 20 patients for the measure group--we believe this does not increase burden on reporters because as currently available claims data show, significantly more EPs are already reporting these measures as individual PQRS measures versus as part of the Cardiovascular Prevention measures group. Ensuring these professionals are recognized for reporting these measures is important in ensuring we are continuing support for this important program despite the measure group no longer being available for reporting.

      Finally, we will also indicate with a green check mark those individuals who have earned the 2014 PQRS Maintenance of Certification Incentive (Additional Incentive) on the Web site in 2015 (78 FR 74450).

      Comment: Several commenters supported publicly reporting earners of the PQRS Maintenance of Certification (MOC) program Additional Incentive, as well as ABMS Board Certification data, while other commenters are concerned that ABMS data are not complete or only include some specialists. Multiple commenters suggested including other Boards' certifications and MOC programs, cont