Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System Policy Changes and Fiscal Year 2016 Rates; Revisions of Quality Reporting Requirements for Specific Providers, Including Changes Related to the Electronic Health Record Incentive Program; Extensions of the Medicare-Dependent, Small Rural Hospital Program and the Low-Volume Payment Adjustment for Hospitals

 
CONTENT

Federal Register, Volume 80 Issue 158 (Monday, August 17, 2015)

Federal Register Volume 80, Number 158 (Monday, August 17, 2015)

Rules and Regulations

Pages 49325-49843

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

FR Doc No: 2015-19049

Page 49325

Vol. 80

Monday,

No. 158

August 17, 2015

Part II

Department of Health and Human Services

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Centers for Medicare & Medicaid Services

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42 CFR Part 412

Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System Policy Changes and Fiscal Year 2016 Rates; Revisions of Quality Reporting Requirements for Specific Providers, Including Changes Related to the Electronic Health Record Incentive Program; Extensions of the Medicare-Dependent, Small Rural Hospital Program and the Low-Volume Payment Adjustment for Hospitals; Final Rule

Page 49326

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 412

CMS-1632-F and IFC

RIN-0938-AS41

Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System Policy Changes and Fiscal Year 2016 Rates; Revisions of Quality Reporting Requirements for Specific Providers, Including Changes Related to the Electronic Health Record Incentive Program; Extensions of the Medicare-Dependent, Small Rural Hospital Program and the Low-Volume Payment Adjustment for Hospitals

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

ACTION: Final rule; interim final rule with comment period.

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SUMMARY: We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2016. Some of these changes implement certain statutory provisions contained in the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively known as the Affordable Care Act), the Pathway for Sustainable Growth Reform (SGR) Act of 2013, the Protecting Access to Medicare Act of 2014, the Improving Medicare Post-

Acute Care Transformation Act of 2014, the Medicare Access and CHIP Reauthorization Act of 2015, and other legislation. We also are addressing the update of the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits for FY 2016. As an interim final rule with comment period, we are implementing the statutory extensions of the Medicare-dependent, small rural hospital (MDH) Program and changes to the payment adjustment for low-volume hospitals under the IPPS.

We also are updating the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2016 and implementing certain statutory changes to the LTCH PPS under the Affordable Care Act and the Pathway for Sustainable Growth Rate (SGR) Reform Act of 2013 and the Protecting Access to Medicare Act of 2014.

In addition, we are establishing new requirements or revising existing requirements for quality reporting by specific providers (acute care hospitals, PPS-exempt cancer hospitals, and LTCHs) that are participating in Medicare, including related provisions for eligible hospitals and critical access hospitals participating in the Medicare Electronic Health Record (EHR) Incentive Program. We also are updating policies relating to the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program.

DATES: Effective Date: This final rule is effective on October 1, 2015.

Applicability Date: The provisions of the interim final rule with comment period portion of this rule (presented in section IV.L. of the preamble) are applicable for discharges on or after April 1, 2015 and on or before September 30, 2017.

Comment Period: To be assured consideration, comments on the interim final rule with comment period presented in section IV.L. of this document must be received at one of the addresses provided in the ADDRESSES section no later than 5 p.m. EST on September 29, 2015.

ADDRESSES: In commenting, please refer to file code CMS-1632-IFC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

You may submit comments in one of four ways (no duplicates, please):

1. Electronically. You may (and we encourage you to) submit electronic comments on this regulation to http://www.regulations.gov. Follow the instructions under the ``submit a comment'' tab.

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-1632-IFC, P.O. Box 8013, Baltimore, MD 21244-1850.

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 via express or overnight mail to the following address ONLY:

Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1632-IFC, 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 the 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 information on viewing public comments, we refer readers to the beginning of the SUPPLEMENTARY INFORMATION section.

    FOR FURTHER INFORMATION CONTACT: Ing-Jye Cheng, (410) 786-4548 and Donald Thompson, (410) 786-4487, Operating Prospective Payment, MS-

    DRGs, Deficit Reduction Act Hospital-Acquired Acquired Conditions--

    Present on Admission (DRA HAC-POA) Program, Hospital-Acquired Conditions Reduction Program, Hospital Readmission Reductions Program, Wage Index, New Medical Service and Technology Add-On Payments, Hospital Geographic Reclassifications, Graduate Medical Education, Capital Prospective Payment, Excluded Hospitals, Medicare Disproportionate Share Hospital (DSH), Medicare-dependent, small rural hospital (MDH), and Low Volume Hospital Payment Adjustment Issues.

    Michele Hudson, (410) 786-4487, Long-Term Care Hospital Prospective

    Page 49327

    Payment System and MS-LTC-DRG Relative Weights Issues.

    Siddhartha Mazumdar, (410) 786-6673, Rural Community Hospital Demonstration Program Issues.

    Cindy Tourison, (410) 786-1093, Hospital Inpatient Quality Reporting and Hospital Value-Based Purchasing--Program Administration, Validation, and Reconsideration Issues.

    Pierre Yong, (410) 786-8896, Hospital Inpatient Quality Reporting--

    Measures Issues Except Hospital Consumer Assessment of Healthcare Providers and Systems Issues.

    Elizabeth Goldstein, (410) 786-6665, Hospital Inpatient Quality Reporting--Hospital Consumer Assessment of Healthcare Providers and Systems Measures Issues.

    Mary Pratt, (410) 786-6867, LTCH Quality Data Reporting Issues.

    Kim Spalding Bush, (410) 786-3232, Hospital Value-Based Purchasing Efficiency Measures Issues.

    James Poyer, (410) 786-2261, PPS-Exempt Cancer Hospital Quality Reporting Issues.

    Deborah Krauss, (410) 786-5264, and Alexandra Mugge, (410) 786-

    4457, EHR Incentive Program Clinical Quality Measure Related Issues.

    Elizabeth Myers, (410) 786-4751, EHR Incentive Program Nonclinical Quality Measure Related Issues.

    Lauren Wu, (202) 690-7151, Certified EHR Technology Related Issues.

    Kellie Shannon, (410) 786-0416, Simplified Cost Allocation Methodology Issues

    SUPPLEMENTARY INFORMATION:

    Electronic Access

    Inspection of Public Comments: All public comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all public 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.

    This Federal Register document is also available from the Federal Register online database through Federal Digital System (FDsys), a service of the U.S. Government Printing Office. This database can be accessed via the Internet at: http://www.gpo.gov/fdsys.

    Tables Available Only Through the Internet on the CMS Web site

    In the past, a majority of the tables referred to throughout this preamble and in the Addendum to the proposed rule and the final rule were published in the Federal Register as part of the annual proposed and final rules. However, beginning in FY 2012, some of the IPPS tables and LTCH PPS tables are no longer published in the Federal Register. Instead, these tables are generally only available through the Internet. The IPPS tables for this final rule are available through the Internet on the CMS Web site at: http://www.cms.hhs.gov/Medicare/medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html. Click on the link on the left side of the screen titled, ``FY 2016 IPPS Final Rule Home Page'' or ``Acute Inpatient--Files for Download''. The LTCH PPS tables for this FY 2016 final rule are available through the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/LongTermCareHospitalPPS/index.html under the list item for Regulation Number CMS-1632-F. For further details on the contents of the tables referenced in this final rule, we refer readers to section VI. of the Addendum to this final rule.

    Readers who experience any problems accessing any of the tables that are posted on the CMS Web sites identified above should contact Michael Treitel at (410) 786-4552.

    Acronyms

    3M 3M Health Information System

    AAMC Association of American Medical Colleges

    ACGME Accreditation Council for Graduate Medical Education

    ACoS American College of Surgeons

    AHA American Hospital Association

    AHIC American Health Information Community

    AHIMA American Health Information Management Association

    AHRQ Agency for Healthcare Research and Quality

    AJCC American Joint Committee on Cancer

    ALOS Average length of stay

    ALTHA Acute Long Term Hospital Association

    AMA American Medical Association

    AMGA American Medical Group Association

    AMI Acute myocardial infarction

    AOA American Osteopathic Association

    APR DRG All Patient Refined Diagnosis Related Group System

    APRN Advanced practice registered nurse

    ARRA American Recovery and Reinvestment Act of 2009, Public Law 111-

    5

    ASCA Administrative Simplification Compliance Act of 2002, Public Law 107-105

    ASITN American Society of Interventional and Therapeutic Neuroradiology

    ASPE Assistant Secretary for Planning and Evaluation DHHS

    ATRA American Taxpayer Relief Act of 2012, Public Law 112-240

    BBA Balanced Budget Act of 1997, Public Law 105-33

    BBRA Medicare, Medicaid, and SCHIP State Children's Health Insurance Program Balanced Budget Refinement Act of 1999, Public Law 106-113

    BIPA Medicare, Medicaid, and SCHIP State Children's Health Insurance Program Benefits Improvement and Protection Act of 2000, Public Law 106-554

    BLS Bureau of Labor Statistics

    CABG Coronary artery bypass graft surgery

    CAH Critical access hospital

    CARE Medicare Continuity Assessment Record & Evaluation Instrument

    CART CMS Abstraction & Reporting Tool

    CAUTI Catheter-associated urinary tract infection

    CBSAs Core-based statistical areas

    CC Complication or comorbidity

    CCN CMS Certification Number

    CCR Cost-to-charge ratio

    CDAC Medicare Clinical Data Abstraction Center

    CDAD Clostridium difficile-associated disease

    CDC Center for Disease Control and Prevention

    CERT Comprehensive error rate testing

    CDI Clostridium difficile (C. difficile)

    CFR Code of Federal Regulations

    CLABSI Central line-associated bloodstream infection

    CIPI Capital input price index

    CMI Case-mix index

    CMS Centers for Medicare & Medicaid Services

    CMSA Consolidated Metropolitan Statistical Area

    COBRA Consolidated Omnibus Reconciliation Act of 1985, Public Law 99-272

    COLA Cost-of-living adjustment

    COPD Chronis obstructive pulmonary disease

    CPI Consumer price index

    CQM Clinical quality measure

    CY Calendar year

    DACA Data Accuracy and Completeness Acknowledgement

    DPP Disproportionate patient percentage

    DRA Deficit Reduction Act of 2005, Public Law 109-171

    DRG Diagnosis-related group

    DSH Disproportionate share hospital

    EBRT External Bean Radiotherapy

    ECI Employment cost index

    eCQM Electronic clinical quality measure

    EDB Medicare Enrollment Database

    EHR Electronic health record

    EMR Electronic medical record

    EMTALA Emergency Medical Treatment and Labor Act of 1986, Public Law 99-272

    EP Eligible professional

    FAH Federation of American Hospitals

    FDA Food and Drug Administration

    FFY Federal fiscal year

    FPL Federal poverty line

    FQHC Federally qualified health center

    FR Federal Register

    FTE Full-time equivalent

    FY Fiscal year

    GAF Geographic Adjustment Factor

    Page 49328

    GME Graduate medical education

    HAC Hospital-acquired condition

    HAI Healthcare-associated infection

    HCAHPS Hospital Consumer Assessment of Healthcare Providers and Systems

    HCFA Health Care Financing Administration

    HCO High-cost outlier

    HCP Healthcare personnel

    HCRIS Hospital Cost Report Information System

    HHA Home health agency

    HHS Department of Health and Human Services

    HICAN Health Insurance Claims Account Number

    HIPAA Health Insurance Portability and Accountability Act of 1996, Public Law 104-191

    HIPC Health Information Policy Council

    HIS Health information system

    HIT Health information technology

    HMO Health maintenance organization

    HPMP Hospital Payment Monitoring Program

    HSA Health savings account

    HSCRC Maryland Health Services Cost Review Commission

    HSRV Hospital-specific relative value

    HSRVcc Hospital-specific relative value cost center

    HQA Hospital Quality Alliance

    HQI Hospital Quality Initiative

    HwH Hospital-within-hospital

    IBR Intern- and Resident-to-Bed Ratio

    ICD-9-CM International Classification of Diseases, Ninth Revision, Clinical Modification

    ICD-10-CM International Classification of Diseases, Tenth Revision, Clinical Modification

    ICD-10-PCS International Classification of Diseases, Tenth Revision, Procedure Coding System

    ICR Information collection requirement

    ICU Intensive care unit

    IGI IHS Global Insight, Inc.

    IHS Indian Health Service

    IME Indirect medical education

    I-O Input-Output

    IOM Institute of Medicine

    IPF Inpatient psychiatric facility

    IPFQR Inpatient Psychiatric Facility Quality Reporting Program

    IPPS Acute care hospital inpatient prospective payment system

    IRF Inpatient rehabilitation facility

    IQR Inpatient Quality Reporting

    LAMCs Large area metropolitan counties

    LOS Length of stay

    LTC-DRG Long-term care diagnosis-related group

    LTCH Long-term care hospital

    LTCH QRP Long-Term Care Hospital Quality Reporting Program

    MAC Medicare Administrative Contractor

    MACRA Medicare Access and CHIP Reauthorization Act of 2015, Public Law 114-10

    MAP Measure Application Partnership

    MCC Major complication or comorbidity

    MCE Medicare Code Editor

    MCO Managed care organization

    MDC Major diagnostic category

    MDH Medicare-dependent, small rural hospital

    MedPAC Medicare Payment Advisory Commission

    MedPAR Medicare Provider Analysis and Review File

    MEI Medicare Economic Index

    MGCRB Medicare Geographic Classification Review Board

    MIEA-TRHCA Medicare Improvements and Extension Act, Division B of the Tax Relief and Health Care Act of 2006, Public Law 109-432

    MIPPA Medicare Improvements for Patients and Providers Act of 2008, Public Law 110-275

    MMA Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173

    MMEA Medicare and Medicaid Extenders Act of 2010, Public Law 111-309

    MMSEA Medicare, Medicaid, and SCHIP Extension Act of 2007, Public Law 110-173

    MRHFP Medicare Rural Hospital Flexibility Program

    MRSA Methicillin-resistant Staphylococcus aureus

    MSA Metropolitan Statistical Area

    MS-DRG Medicare severity diagnosis-related group

    MS-LTC-DRG Medicare severity long-term care diagnosis-related group

    MU Meaningful Use EHR Incentive Program

    NAICS North American Industrial Classification System

    NALTH National Association of Long Term Hospitals

    NCD National coverage determination

    NCHS National Center for Health Statistics

    NCQA National Committee for Quality Assurance

    NCVHS National Committee on Vital and Health Statistics

    NECMA New England County Metropolitan Areas

    NHSN National Healthcare Safety Network

    NQF National Quality Forum

    NQS National Quality Strategy

    NTIS National Technical Information Service

    NTTAA National Technology Transfer and Advancement Act of 1991, Public Law 104-113

    NUBC National Uniform Billing Code

    NVHRI National Voluntary Hospital Reporting Initiative

    OACT CMS Office of the Actuary

    OBRA 86 Omnibus Budget Reconciliation Act of 1986, Public Law 99-509

    OES Occupational employment statistics

    OIG Office of the Inspector General

    OMB Executive Office of Management and Budget

    ONC Office of the National Coordinator for Health Information Technology

    OPM U.S. Office of Personnel Management

    OQR Hospital Outpatient Quality Reporting

    O.R. Operating room

    OSCAR Online Survey Certification and Reporting System

    PAC Postacute care

    PAMA Protecting Access to Medicare Act of 2014, Public Law 113-93

    PCH PPS-exempt cancer hospital

    PCHQR PPS-exempt cancer hospital quality reporting

    PMSAs Primary metropolitan statistical areas

    POA Present on admission

    PPI Producer price index

    PPS Prospective payment system

    PRM Provider Reimbursement Manual

    ProPAC Prospective Payment Assessment Commission

    PRRB Provider Reimbursement Review Board

    PRTFs Psychiatric residential treatment facilities

    PSF Provider-Specific File

    PSI Patient safety indicator

    PS&R Provider Statistical and Reimbursement System

    PQRS Physician Quality Reporting System

    QIG Quality Improvement Group CMS

    QRDA Quality Reporting Data Architecture

    RFA Regulatory Flexibility Act, Public Law 96-354

    RHC Rural health clinic

    RHQDAPU Reporting hospital quality data for annual payment update

    RNHCI Religious nonmedical health care institution

    RPL Rehabilitation psychiatric long-term care (hospital)

    RRC Rural referral center

    RSMR Risk-standardized mortality rate

    RSRR Risk-standard readmission rate

    RTI Research Triangle Institute, International

    RUCAs Rural-urban commuting area codes

    RY Rate year

    SAF Standard Analytic File

    SCH Sole community hospital

    SCHIP State Child Health Insurance Program

    SCIP Surgical Care Improvement Project

    SFY State fiscal year

    SGR Sustainable Growth Rate

    SIC Standard Industrial Classification

    SNF Skilled nursing facility

    SOCs Standard occupational classifications

    SOM State Operations Manual

    SSI Surgical site infection

    SSI Supplemental Security Income

    SSO Short-stay outlier

    SUD Substance use disorder

    TEFRA Tax Equity and Fiscal Responsibility Act of 1982, Public Law 97-248

    TEP Technical expert panel

    THA/TKA Total hip arthroplasty/Total knee arthroplasty

    TMA TMA Transitional Medical Assistance, Abstinence Education, and QI Qualifying Individuals Programs Extension Act of 2007, Public Law 110-90

    TPS Total Performance Score

    UHDDS Uniform hospital discharge data set

    UMRA Unfunded Mandate Reform Act, Public Law 104-4

    VBP Hospital Value Based Purchasing Program

    VTE Venous thromboembolism

    Table of Contents

    I. Executive Summary and Background

    A. Executive Summary

    1. Purpose and Legal Authority

    2. Summary of the Major Provisions

    3. Summary of Costs and Benefits

    B. Summary

    1. Acute Care Hospital Inpatient Prospective Payment System (IPPS)

    Page 49329

    2. Hospitals and Hospital Units Excluded From the IPPS

    3. Long-Term Care Hospital Prospective Payment System (LTCH PPS)

    4. Critical Access Hospitals (CAHs)

    5. Payments for Graduate Medical Education (GME)

    C. Summary of Provisions of Recent Legislation Discussed in This Final Rule and Interim Final Rule With Comment Period

    1. Patient Protection and Affordable Care Act (Pub. L. 111-148) and the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152)

    2. American Taxpayer Relief Act of 2012 (Pub. L. 112-240)

    3. Pathway for Sustainable Growth Rate (SGR) Reform Act of 2013 (Pub. L. 113-67)

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

    5. Improving Medicare Post-Acute Care Transformation Act of 2014

    6. Medicare Access and CHIP Reauthorization Act of 2015 (Pub. L. 114-10)

    D. Issuance of a Notice of Proposed Rulemaking

    E. Public Comments Received in Response to the FY 2016 IPPS/LTCH PPS Proposed Rule

    II. Changes to Medicare Severity Diagnosis-Related Group (MS-DRG) Classifications and Relative Weights

    A. Background

    B. MS-DRG Reclassifications

    C. Adoption of the MS-DRGs in FY 2008

    D. FY 2016 MS-DRG Documentation and Coding Adjustment

    1. Background on the Prospective MS-DRG Documentation and Coding Adjustments for FY 2008 and FY 2009 Authorized by Public Law 110-90

    2. Adjustment to the Average Standardized Amounts Required by Public Law 110-90

  3. Prospective Adjustment Required by Section 7(b)(1)(A) of Public Law 110-90

  4. Recoupment or Repayment Adjustments in FYs 2010 Through 2012 Required by Section 7(b)(1)(B) Public Law 110-90

    3. Retrospective Evaluation of FY 2008 and FY 2009 Claims Data

    4. Prospective Adjustments for FY 2008 and FY 2009 Authorized by Section 7(b)(1)(A) of Public Law 110-90

    5. Recoupment or Repayment Adjustment Authorized by Section 7(b)(1)(B) of Public Law 110-90

    6. Recoupment or Repayment Adjustment Authorized by Section 631 of the American Taxpayer Relief Act of 2012 (ATRA)

    E. Refinement of the MS-DRG Relative Weight Calculation

    1. Background

    2. Discussion for FY 2016 and Summary of Public Comments Received in Response to Our Solicitation of Comments on Nonstandard Cost Center Codes

    F. Adjustment to MS-DRGs for Preventable Hospital-Acquired Conditions (HACs), Including Infections, for FY 2016

    1. Background

    2. HAC Selection

    3. Present on Admission (POA) Indicator Reporting

    4. HACs and POA Reporting in Preparation for Transition to ICD-

    10-CM and ICD-10-PCS

    5. Changes to the HAC Program for FY 2016

    6. RTI Program Evaluation

    7. RTI Report on Evidence-Based Guidelines

    G. Changes to Specific MS-DRG Classifications

    1. Discussion of Changes to Coding System and Basis for MS-DRG Updates

  5. Conversion of MS-DRGs to the International Classification of Diseases, 10th Edition (ICD-10)

  6. Basis for FY 2016 MS-DRG Updates

    2. MDC 1 (Diseases and Disorders of the Nervous System): Endovascular Embolization (Coiling) Procedures

    3. MDC 5 (Diseases and Disorders of the Circulatory System)

  7. Adding Severity Levels to MS-DRGs 245 Through 251

  8. Percutaneous Intracardiac Procedures

  9. Zilversupreg PTX Drug-Eluting Peripheral Stent (ZPTXsupreg)

  10. Percutaneous Mitral Valve Repair System--Revision of ICD-10-

    PCS Version 32 Logic

  11. Major Cardiovascular Procedures: Zenithsupreg Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft

    4. MDC 8 (Diseases and Disorders of the Musculoskeletal System and Connective Tissue)

  12. Revision of Hip or Knee Replacement: Revision of ICD-10 Version 32 Logic

  13. Spinal Fusion

    5. MDC 14 (Pregnancy, Childbirth and the Puerperium): MS-DRG 775 (Vaginal Delivery With Complicating Diagnosis)

    6. MDC 21 (Injuries, Poisoning and Toxic Effects of Drugs): CroFab Antivenin Drug

    7. MDC 22 (Burns): Additional Severity of Illness Level for MS-

    DRG 927 (Extensive Burns or Full Thickness Burns With Mechanical Ventilation 96 + Hours With Skin Graft)

    8. Medicare Code Editor (MCE) Changes

    9. Changes to Surgical Hierarchies

    10. Changes to the MS-DRG Diagnosis Codes for FY 2016

  14. Major Complications or Comorbidities (MCCs) and Complications or Comorbidities (CCs) Severity Levels for FY 2016

  15. Coronary Atherosclerosis Due to Calcified Coronary Lesion

  16. Hydronephrosis

    11. Complications or Comorbidity (CC) Exclusions List for FY 2016

  17. Background

  18. CC Exclusions List for FY 2016

    12. Review of Procedure Codes in MS-DRGs 981 Through 983, 984 Through 986, and 987 Through 989

  19. Moving Procedure Codes From MS-DRGs 981 Through 983 or MS-

    DRGs 987 Through 989 Into MDCs

  20. Reassignment of Procedures Among MS-DRGs 981 Through 983, 984 Through 986, and 987 Through 989

  21. Adding Diagnosis or Procedure Codes to MDCs

    13. Changes to the ICD-9-CM Coding System in FY 2016

  22. ICD-10 Coordination and Maintenance Committee

  23. Code Freeze

    14. Other Policy Change: Recalled/Replaced Devices

    15. Out of Scope Public Comments

    H. Recalibration of the FY 2016 MS-DRG Relative Weights

    1. Data Sources for Developing the Relative Weights

    2. Methodology for Calculation of the Relative Weights

    3. Development of National Average CCRs

    4. Discussion and Acknowledgement of Public Comments Received on Expanding the Bundled Payments for Care Improvement (BPCI) Initiative

  24. Background

  25. Considerations for Potential Model Expansion

    I. Add-On Payments for New Services and Technologies

    1. Background

    2. Public Input Before Publication of a Notice of Proposed Rulemaking on Add-On Payments

    3. Implementation of ICD-10-PCS Section ``X'' Codes for Certain New Medical Services and Technologies for FY 2016

    4. FY 2016 Status of Technologies Approved for FY 2015 Add-On Payments

  26. Glucarpidase (Voraxazesupreg)

  27. Zenithsupreg Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft

  28. KcentraTM

  29. Argussupreg II Retinal Prosthesis System

  30. ZilversupregPTXsupreg Drug-Eluting Peripheral Stent

  31. CardioMEMSTM HF (Heart Failure) Monitoring System

  32. MitraClipsupreg System

  33. Responsive Neurostimulator (RNSsupreg System)

    5. FY 2016 Applications for New Technology Add-On Payments

  34. Blinatumomab (BLINCYTOTM)

  35. DIAMONDBACKsupreg 360 Coronary Orbital Atherectomy System

  36. CRESEMBAsupreg (Isavuconazonium)

  37. LUTONIXsupreg Drug Coated Balloon (DCB) Percutaneous Transluminal Angioplasty (PTA) and IN.PACTTMAdmiralTM Pacliaxel Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

  38. VERASENSETM Knee Balancer System (VKS)

  39. WATCHMANsupreg Left Atrial Appendage Closure Technology

    III. Changes to the Hospital Wage Index for Acute Care Hospitals

    A. Background

    1. Legislative Authority

    2. Core-Based Statistical Areas (CBSAs) for the Hospital Wage Index

    B. Worksheet S-3 Wage Data for the FY 2016 Wage Index

    1. Included Categories of Costs

    2. Excluded Categories of Costs

    3. Use of Wage Index Data by Suppliers and Providers Other Than Acute Care Hospitals Under the IPPS

    C. Verification of Worksheet S-3 Wage Data

    Page 49330

    D. Method for Computing the FY 2016 Unadjusted Wage Index

    E. Occupational Mix Adjustment to the FY 2016 Wage Index

    1. Development of Data for the FY 2016 Occupational Mix Adjustment Based on the 2013 Medicare Wage Index Occupational Mix Survey

    2. New 2013 Occupational Mix Survey Data for the FY 2016 Wage Index

    3. Calculation of the Occupational Mix Adjustment for FY 2016

    F. Analysis and Implementation of the Occupational Mix Adjustment and the FY 2016 Occupational Mix Adjusted Wage Index

    G. Transitional Wage Indexes

    1. Background

    2. Transition for Hospitals in Urban Areas That Became Rural

    3. Transition for Hospitals Deemed Urban Under Section 1886(d)(8)(B) of the Act Where the Urban Area Became Rural Under the New OMB Delineations

    4. Expiring Transition for Hospitals That Experience a Decrease in Wage Index Under the New OMB Delineations

    5. Budget Neutrality

    H. Application of the Rural, Imputed, and Frontier Floors

    1. Rural Floor

    2. Imputed Floor for FY 2016

    3. State Frontier Floor

    I. FY 2016 Wage Index Tables

    J. Revisions to the Wage Index Based on Hospital Redesignations and Reclassifications

    1. General Policies and Effects of Reclassification and Redesignation

    2. FY 2016 MGCRB Reclassifications and Redesignation Issues

  40. FY 2016 Reclassification Requests and Approvals

  41. Applications for Reclassifications for FY 2017

    3. Redesignations of Hospitals Under Section 1886(d)(8)(B) of the Act (Lugar)

    4. Waiving Lugar Redesignation for the Out-Migration Adjustment

    K. Out-Migration Adjustment Based on Commuting Patterns of Hospital Employees

    1. Background

    2. New Data Source for the FY 2016 Out-Migration Adjustment

    3. FY 2016 Out-Migration Adjustment

    4. Use of Out-Migration Data Applied for FY 2014 or FY 2015 for 3 Years

    L. Process for Requests for Wage Index Data Corrections

    M. Labor-Related Share for the FY 2016 Wage Index

    N. Changes to 3-Year Average for the FY 2017 Wage Index Pension Costs and Change to Wage Index Timeline Regarding Pension Costs for FY 2017 and Subsequent Years

    O. Clarification of Allocation of Pension Costs for the Wage Index

    IV. Other Decisions and Changes to the IPPS for Operating Costs and Indirect Medical Education (IME) Costs

    A. Changes in the Inpatient Hospital Updates for FY 2016 (Sec. Sec. 412.64(d) and 412.211(c))

    1. FY 2016 Inpatient Hospital Update

    2. FY 2016 Puerto Rico Hospital Update

    B. Rural Referral Centers (RRCs): Annual Updates to Case-Mix Index (CMI) and Discharge Criteria (Sec. 412.96)

    1. Case-Mix Index (CMI)

    2. Discharges

    C. Indirect Medical Education (IME) Payment Adjustment for FY 2016 (Sec. 412.105)

    D. FY 2016 Payment Adjustment for Medicare Disproportionate Share Hospitals (DSHs) (Sec. 412.106)

    1. Background

    2. Impact on Medicare DSH Payment Adjustment of the Continued Implementation of New OMB Labor Market Area Delineations

    3. Payment Adjustment Methodology for Medicare Disproportionate Share Hospitals (DSHs) Under Section 3133 of the Affordable Care Act

  42. General Discussion

  43. Eligibility for Empirically Justified Medicare DSH Payments and Uncompensated Care Payments

  44. Empirically Justified Medicare DSH Payments

  45. Uncompensated Care Payments

    E. Hospital Readmissions Reduction Program: Changes for FY 2016 Through FY 2017 (Sec. Sec. 412.150 Through 412.154)

    1. Statutory Basis for the Hospital Readmissions Reduction Program

    2. Regulatory Background

    3. Overview of Policies Changes for the FY 2016 and FY 2017 Hospital Readmissions Reduction Program

    4. Refinement of Hospital 30-Day, All Cause, Risk-Standardized Readmission Rate (RSSR) Following Pneumonia Hospitalization Measure Cohort (NQF #0506) for FY 2017 Payment Determination and Subsequent Years

  46. Background

  47. Overview of Measure Cohort Change

  48. Risk Adjustment

  49. Anticipated Effect of Refinement of Hospital 30-Day, All-

    Cause, Risk-Standardized Readmission Rate (RSSR) Following Pneumonia Hospitalization Measure (NQF #0506) Cohort

  50. Calculating the Excess Readmissions Ratio

    5. Maintenance of Technical Specifications for Quality Measures

    6. Floor Adjustment Factor for FY 2016 (Sec. 412.154(c)(2))

    7. Applicable Period for FY 2016

    8. Calculation of Aggregate Payments for Excess Readmissions for FY 2016

  51. Background

  52. Calculation of Aggregate Payments

    9. Extraordinary Circumstances Exception Policy for the Hospital Readmissions Reduction Program Beginning FY 2016 and for Subsequent Years

  53. Background

  54. Requests for an Extraordinary Circumstances Exception

    F. Hospital Value-Based Purchasing (VBP) Program: Policy Changes for the FY 2018 Program Year and Subsequent Years

    1. Background

  55. Statutory Background and Overview of Past Program Years

  56. FY 2016 Program Year Payment Details

    2. Retention, Removal, Expansion, and Updating of Quality Measures for FY 2018 Program Year

  57. Retention of Previously Adopted Hospital VBP Program Measures for the FY 2018 Program Year

  58. Removal of Two Measures

  59. New Measure for the FY 2018 Program Year: 3-Item Care Transition Measure (CTM-3) (NQF #0228)

  60. Removal of Clinical Care--Process Subdomain for the FY 2018 Program Year and Subsequent Years

  61. NHSN Measures Standard Population Data

  62. Summary of Previously Adopted and New Measures for the FY 2018 Program Year

    3. Previously Adopted and New Measures for the FY 2019, FY 2021, and Subsequent Program Years

  63. Intent To Propose in Future Rulemaking To Include Selected Ward (Non-Intensive Care Unit (ICU)) Locations in Certain NHSN Measures Beginning With the FY 2019 Program Year

  64. New Measure for the FY 2021 Program Year: Hospital 30-Day, All-Cause, Risk-Standardized Mortality Rate Following Chronic Obstructive Pulmonary Disease (COPD) Hospitalization (NQF #1893)

  65. Summary of Previously Adopted and New Measures for the FY 2019 and FY 2021 and Subsequent Program Years

    4. Possible Measure Topics for Future Program Years

    5. Previously Adopted and New Baseline and Performance Periods for the FY 2018 Program Year

  66. Background

  67. Baseline and Performance Periods for the Patient and Caregiver-Centered Experience of Care/Care Coordination Domain for the FY 2018 Program Year

  68. Baseline and Performance Periods for NHSN Measures and PC-01 in the Safety Domain for the FY 2018 Program Year

  69. Baseline and Performance Periods for the Efficiency and Cost Reduction Domain for the FY 2018 Program Year

  70. Summary of Previously Finalized and New Baseline and Performance Periods for the FY 2018 Program Year

    6. Previously Adopted and New Baseline and Performance Periods for Future Program Years

  71. Previously Adopted Baseline and Performance Periods for the FY 2019 Program

  72. Baseline and Performance Periods for the PSI-90 Measure in the Safety Domain in the FY 2020 Program Years

  73. Baseline and Performance Periods for the Clinical Care Domain for the FY 2021 Program Year

    7. Performance Standards for the Hospital VBP Program

  74. Background

  75. Technical Updates

  76. Performance Standards for the FY 2018 Program Year

  77. Previously Adopted Performance Standards for Certain Measures for the FY 2019 Program Year

  78. Previously Adopted and New Performance Standards for Certain Measures for the FY 2020 Program Year

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  79. Performance Standards for Certain Measures for the FY 2021 Program Year

    8. FY 2018 Program Year Scoring Methodology

  80. Domain Weighting for the FY 2018 Program Year for Hospitals That Receive a Score on All Domains

  81. Domain Weighting for the FY 2018 Program Year for Hospitals Receiving Scores on Fewer Than Four Domains

    G. Changes to the Hospital-Acquired Condition (HAC) Reduction Program

    1. Background

    2. Statutory Basis for the HAC Reduction Program

    3. Overview of Previous HAC Reduction Program Rulemaking

    4. Implementation of the HAC Reduction Program for FY 2016

    5. Changes for Implementation of the HAC Reduction Program for FY 2017

  82. Applicable Time Period for the FY 2017 HAC Reduction Program

  83. Narrative Rule Used in Calculation of the Domain 2 Score for the FY 2017 HAC Reduction Program

  84. Domain 1 and Domain 2 Weights for the FY 2017 HAC Reduction Program

    6. Measure Refinements for the FY 2018 HAC Reduction Program

  85. Inclusion of Select Ward (Non-Intensive Care Unit (ICU)) Locations in Certain CDC NHSN Measures Beginning in the FY 2018 Program Year

  86. Update to CDC NHSN Measures Standard Population Data

    7. Maintenance of Technical Specifications for Quality Measures

    8. Extraordinary Circumstances Exception Policy for the HAC Reduction Program Beginning in FY 2016 and for Subsequent Years

  87. Background

  88. Requests for an Extraordinary Circumstances Exception

    H. Simplified Cost Allocation Methodology

    1. Background

    2. Proposed Regulatory Changes

    3. Summary of Public Comments, Our Responses, and Final Policy

    I. Rural Community Hospital Demonstration Program

    1. Background

    2. FY 2016 Budget Neutrality Offset Amount

    J. Changes to MS-DRGs Subject to the Postacute Care Transfer Policy (Sec. 412.4)

    1. Background

    2. Changes to the Postacute Care Transfer MS-DRGs

    K. Short Inpatient Hospital Stays

    L. Interim Final Rule With Comment Period Implementing Legislative Extensions Relating to the Payment Adjustment for Low-

    Volume Hospitals and the Medicare-Dependent, Small Rural Hospital (MDH) Program

    1. Recent Legislation

    2. Payment Adjustment for Low-Volume Hospitals (Sec. 412.101)

  89. Background

  90. Implementation of Provisions of the MACRA for FY 2015

  91. Low-Volume Hospital Definition and Payment Adjustment for FY 2016

    3. Medicare-Dependent, Small Rural Hospital (MDH) Program (Sec. 412.108)

  92. Background for MDH Program

  93. MACRA Provisions for Extension of the MDH Program

    4. Response to Comments

    5. Waiver of Notice of Proposed Rulemaking and Delay in Effective Date

    6. Collection of Information Requirements

    7. Impact of Legislative Changes

    V. Changes to the IPPS for Capital-Related Costs

    A. Overview

    B. Additional Provisions

    1. Exception Payments

    2. New Hospitals

    3. Hospitals Located in Puerto Rico

    C. Annual Update for FY 2016

    VI. Changes for Hospitals Excluded from the IPPS

    A. Rate-of-Increase in Payments To Excluded Hospitals for FY 2016

    B. Report of Adjustment (Exceptions) Payments

    C. Out of Scope Comments Relating to Critical Access Hospitals (CAHs) Inpatient Services

    VII. Changes to the Long-Term Care Hospital Prospective Payment System (LTCH PPS) for FY 2016

    A. Background of the LTCH PPS

    1. Legislative and Regulatory Authority

    2. Criteria for Classification as an LTCH

  94. Classification as an LTCH

  95. Hospitals Excluded From the LTCH PPS

    3. Limitation on Charges to Beneficiaries

    4. Administrative Simplification Compliance Act (ASCA) and Health Insurance Portability and Accountability Act (HIPAA) Compliance

    B. Application of Site Neutral Payment Rate (New Sec. 412.522)

    1. Overview

    2. Application of the Site Neutral Payment Rate Under the LTCH PPS

    3. Criteria for Exclusion from the Site Neutral Payment Rate

  96. Statutory Provisions

  97. Implementation of Criterion for a Principal Diagnosis Relating to a Psychiatric Diagnosis or to Rehabilitation

  98. Addition of Definition of ``Subsection (d) Hospital'' to LTCH Regulations

  99. Interpretation of ``Immediately Preceded'' by a Subsection (d) Hospital Discharge

  100. Implementation of Intensive Care Unit (ICU) Criterion

  101. Implementation of the Ventilator Criterion

    4. Determination of the Site Neutral Payment Rate (Proposed New Sec. 412.522(c))

  102. General

  103. Blended Payment Rate for FY 2016 and FY 2017

  104. LTCH PPS Standard Federal Payment Rate

    5. Application of Certain Exiting LTCH PPS Payment Adjustments to Payments Made Under the Site Neutral Payment Rate

    6. LTCH Discharge Payment Percentage

    7. Additional LTCH PPS Policy Considerations Related to the Implementation of the Site Neutral Payment Rate Required by Section 1206(a) of Public Law 113-67

  105. MS-LTC-DRG Relative Payment Weights

  106. High-Cost Outliers

  107. Limitation on Charges to Beneficiaries

    C. Medicare Severity Long-Term Care Diagnosis-Related Group (MS-

    LTC-DRG) Classifications and Relative Weights for FY 2016

    1. Background

    2. Patient Classifications into MS-LTC-DRGs

  108. Background

  109. Changes to the MS-LTC-DRGs for FY 2016

    3. Development of the FY 2016 MS-LTC-DRG Relative Weights

  110. General Overview of the Development of the MS-LTC-DRG Relative Weights

  111. Development of the MS-LTC-DRG Relative Weights for FY 2016

  112. Data

  113. Hospital-Specific Relative Value (HSRV) Methodology

  114. Treatment of Severity Levels in Developing the MS-LTC-DRG Relative Weights

  115. Low-Volume MS-LTC-DRGs

  116. Steps for Determining the Proposed FY 2016 MS-LTC-DRG Relative Weights

    D. Changes to the LTCH PPS Standard Payment Rates for FY 2016

    1. Overview of Development of the LTCH PPS Standard Federal Payment Rates

    2. FY 2016 LTCH PPS Annual Market Basket Update

  117. Overview

  118. Revision of Certain Market Basket Updates as Required by the Affordable Care Act

  119. Adjustment to the Annual Update to the LTCH PPS Standard Federal Rate Under the Long-Term Care Hospital Quality Reporting Program (LTCH QRP)

  120. Market Basket Under the LTCH PPS for FY 2016

  121. Annual Market Basket Update for LTCHs for FY 2016

    E. Moratoria on the Establishment of LTCHs and LTCH Satellite Facilities and on the Increase in Number of Beds in Existing LTCHs and LTCH Satellite Facilities

    F. Changes to Average Length of Stay Criterion Under Public Law 113-67 (Sec. 412.23)

    VIII. Quality Data Reporting Requirements for Specific Providers and Suppliers for FY 2016

    A. Hospital Inpatient Quality Reporting (IQR) Program

    1. Background

  122. History of the Hospital IQR Program

  123. Maintenance of Technical Specifications for Quality Measures

  124. Public Display of Quality Measures

    2. Process for Retaining Previously Adopted Hospital IQR Program Measures for Subsequent Payment Determinations

    3. Removal and Suspension of Hospital IQR Program Measures

  125. Considerations in Removing Quality Measures From the Hospital IQR Program

  126. Removal of Hospital IQR Program Measures for the FY 2018 Payment Determination and Subsequent Years

    Page 49332

    4. Previously Adopted Hospital IQR Program Measures for the FY 2017 Payment Determination and Subsequent Years

  127. Background

  128. NHSN Measures Standard Population Data

    5. Expansion and Updating of Quality Measures

    6. Refinements of Existing Measures in the Hospital IQR Program

  129. Refinement of Hospital 30-Day, All-Cause, Risk-Standardized Mortality Rate (RSMR) Following Pneumonia Hospitalization (NQF #0468) Measure Cohort

  130. Refinement of Hospital 30-Day, All-Cause, Risk-Standardized Readmission Rate (RSRR) Following Pneumonia Hospitalization (NQF #0468) Measure Cohort

    7. Additional Hospital IQR Program Measures for the FY 2018 and FY 2019 Payment Determinations and Subsequent Years

  131. Hospital Survey on Patient Safety Culture

  132. Clinical Episode-Based Payment Measures

  133. Hospital-Level, Risk-Standardized Payment Associated With a 90-Day Episode-of-Care for Elective Primary Total Hip Arthroplasty (THA) and/or Total Knee Arthroplasty (TKA)

  134. Excess Days in Acute Care After Hospitalization for Acute Myocardial Infarction

  135. Excess Days in Acute Care After Hospitalization for Heart Failure

  136. Summary of Previously Adopted and New Hospital IQR Program Measure Set for the FY 2018 and FY 2019 Payment Determinations and Subsequent Years

    8. Electronic Clinical Quality Measures

  137. Previously Adopted Voluntarily Reported Electronic Clinical Quality Measures for the FY 2017 Payment Determination

  138. Clarification of the Venous Thromboembolism (VTE) Prophylaxis (STK--01) Measure (NQF #0434)

  139. Requirements for Hospitals To Report Electronic Clinical Quality Measures for the FY 2018 Payment Determination and Subsequent Years

    9. Future Considerations for Electronically Specified Measures: Consideration To Implement a New Type of Measure That Utilizes Core Clinical Data Elements

  140. Background

  141. Overview of Core Clinical Data Elements

  142. Core Clinical Data Elements Development

  143. Core Clinical Data Elements Feasibility Testing Using Readmission and Mortality Models

  144. Use of Core Clinical Data Elements in Hospital Quality Measures for the Hospital IQR Program

  145. Content Exchange Standard Considerations for Core Clinical Data Elements

    10. Form, Manner, and Timing of Quality Data Submission

  146. Background

  147. Procedural Requirements for the FY 2018 Payment Determination and Subsequent Years

  148. Data Submission Requirements for Chart-Abstracted Measures

  149. Alignment of the Medicare EHR Incentive Program Reporting for Eligible Hospitals and CAHs With the Hospital IQR Program

  150. Sampling and Case Thresholds for the FY 2018 Payment Determination and Subsequent Years

  151. HCAHPS Requirements for the FY 2018 Payment Determination and Subsequent Years

  152. Data Submission Requirements for Structural Measures for the FY 2018 Payment Determination and Subsequent Years

  153. Data Submission and Reporting Requirements for Healthcare-

    Associated Infection (HAI) Measures Reported via NHSN

    11. Modifications to the Existing Processes for Validation of Hospital IQR Program Data

  154. Background

  155. Modifications to the Existing Processes for Validation of Chart-Abstracted Hospital IQR Program Data

    12. Data Accuracy and Completeness Acknowledgement Requirements for the FY 2018 Payment Determination and Subsequent Years

    13. Public Display Requirements for the FY 2018 Payment Determination and Subsequent Years

    14. Reconsideration and Appeal Procedures for the FY 2018 Payment Determination and Subsequent Years

    15. Hospital IQR Program Extraordinary Circumstances Extensions or Exemptions

    B. PPS-Exempt Cancer Hospital Quality Reporting (PCHQR) Program

    1. Statutory Authority

    2. Removal of Six Surgical Care Improvement Project (SCIP) Measures From the PCHQR Program Beginning With Fourth Quarter (Q4) 2015 Discharges and for Subsequent Years

    3. New Quality Measures Beginning With the FY 2018 Program

  156. Considerations in the Selection of Quality Measures

  157. Summary of New Measures

  158. CDC NHSN Facility-Wide Inpatient Hospital-Onset Clostridium Difficile (C. difficile) Infection (CDI) Outcome Measure (NQF #1717)

  159. CDC NHSN Facility-Wide Inpatient Hospital-Onset Methicillin-

    Resistant Staphylococcus Aureus (MSRA) Bacteremia Outcome Measure (NQF #1716)

  160. CDC NHSN Influenza Vaccination Coverage Among Healthcare Personnel (HCP) Measure (NQF #0431) (CDC NHSN HCP Measure)

    4. Possible New Quality Measure Topics for Future Years

    5. Maintenance of Technical Specifications for Quality Measures

    6. Public Display Requirements

  161. Background

  162. Additional Public Display Requirements

    7. Form, Manner, and Timing of Data Submission

  163. Background

  164. Reporting Requirements for the Proposed New Measures: CDC NHSN CDI (NQF #1717), CDC NHSN MRSA (NQF #1716), and CDC NHSN HCP (NQF #0431) Measures

    C. Long-Term Care Hospital Quality Reporting Program (LTCH QRP)

    1. Background and Statutory Authority

    2. General Considerations Used for Selection, Resource Use, and Other Quality Measures for the LTCH QRP

    3. Policy for Retention of LTCH QRP Measures Adopted for Previous Payment Determinations

    4. Policy for Adopting Changes to LTCH QRP Measures

    5. Previously Adopted Quality Measures

  165. Previously Adopted Quality Measures for the FY 2015 and FY 2016 Payment Determinations and Subsequent Years

  166. Previously Adopted Quality Measures for the FY 2017 and FY 2018 Payment Determinations and Subsequent Years

    6. Previously Adopted LTCH QRP Quality Measures for the FY 2018 Payment Determinations and Subsequent Years

  167. Policy to Reflect NQF Endorsement: All-Cause Unplanned Readmission Measure for 30 Days Post-Discharge From LTCHs (NQF #2512)

  168. Policy To Address the IMPACT Act of 2014: Quality Measure Addressing the Domain of Skin Integrity and Changes in Skin Integrity: Percent of Residents or Patients With Pressure Ulcers That Are New or Worsened (Short Stay) (NQF #0678)

  169. Policy To Address the IMPACT Act of 2014: Quality Measure Addressing the Domain of Incidence of Major Falls: Application of Percent of Residents Experiencing One or More Falls With Major Injury (Long Stay) (NQF #0674)

  170. Policy To Address the IMPACT Act of 2014: Quality Measure Addressing the Domain of Functional Status, Cognitive Function, and Changes in Function and Cognitive Function: Application of Percent of LTCH Patients With an Admission and Discharge Functional Assessment and a Care Plan That Addresses Function (NQF #2631; Under NQF review)

    7. LTCH QRP Quality Measures for the FY 2019 Payment Determination and Subsequent Years

    8. LTCH QRP Quality Measures and Concepts Under Consideration for Future Years

    9. Form, Manner, and Timing of Quality Data Submission for the FY 2016 Payment Determinations and Subsequent Years

  171. Background

  172. Timing for New LTCHs To Begin Reporting Data to CMS for the FY 2017 Payment Determinations and Subsequent Years

  173. Revisions to Previously Adopted Data Submission Timelines Under the LTCH QRP for the FY 2017 and FY 2018 Payment Determinations and Subsequent Years and Data Collection and Data Submission Timelines for Quality Measures in This Final Rule

    Page 49333

    10. Previously Adopted LTCH QRP Data Completion Thresholds for the FY 2016 Payment Determination and Subsequent Years

    11. Future LTCH QRP Data Validation Process

    12. Public Display of Quality Measure Data for the LTCH QRP

    13. Previously Adopted and New LTCH QRP Reconsideration and Appeals Procedures for the FY 2017 Payment Determination and Subsequent Years

    14. Previously Adopted and New LTCH QRP Submission Exception and Extension Requirements for the FY 2017 Payment Determination and Subsequent Years

    D. Clinical Quality Measurement for Eligible Hospitals and Critical Access Hospitals (CAHs) Participating in the EHR Incentive Programs in 2016

    1. Background

    2. CQM Reporting for the Medicare and Medicaid EHR Incentive Programs in 2016

  174. Background

  175. CQM Reporting Period for the Medicare and Medicaid EHR Incentive Programs for CY 2016

  176. CQM Form and Method for the Medicare EHR Incentive Programs for 2016

    3. ``CQM--Report'' Certification Criterion in ONC's 2015 Edition Proposed Rule

    4. CQM Development and Certification Cycle

    IX. MedPAC Recommendations

    X. Other Required Information

    A. Requests for Data From the Public

    B. Collection of Information Requirements

    1. Statutory Requirement for Solicitation of Comments

    2. ICRs for Add-On Payments for New Services and Technologies

    3. ICRs for the Occupational Mix Adjustment to the FY 2016 Wage Index (Hospital Wage Index Occupational Mix Survey)

    4. Hospital Applications for Geographic Reclassifications by the MGCRB

    5. ICRs for the Hospital Inpatient Quality Reporting (IQR) Program

    6. ICRs for PPS-Exempt Cancer Hospital Quality Reporting (PCHQR) Program

    7. ICRs for Hospital Value-Based Purchasing (VBP) Program

    8. ICRs for the Long-Term Care Hospital Quality Reporting Program (LTCHQR)

    Regulation Text

    Addendum--Schedule of Standardized Amounts, Update Factors, and Rate-

    of-Increase Percentages Effective With Cost Reporting Periods Beginning on or After October 1, 2015 and Payment Rates for LTCHs Effective With Discharges Occurring on or After October 1, 2015

    I. Summary and Background

    II. Changes to the Prospective Payment Rates for Hospital Inpatient Operating Costs for Acute Care Hospitals for FY 2016

    A. Calculation of the Adjusted Standardized Amount

    B. Adjustments for Area Wage Levels and Cost-of-Living

    C. MS-DRG Relative Weights

    D. Calculation of the Prospective Payment Rates

    III. Changes to Payment Rates for Acute Care Hospital Inpatient Capital-Related Costs for FY 2016

    A. Determination of Federal Hospital Inpatient Capital-Related Prospective Payment Rate Update

    B. Calculation of the Inpatient Capital-Related Prospective Payments for FY 2016

    C. Capital Input Price Index

    IV. Changes to Payment Rates for Excluded Hospitals: Rate-of-

    Increase Percentages for FY 2016

    V. Updates to the Payment Rates for the LTCH PPS for FY 2016

    A. LTCH PPS Standard Federal Payment Rate for FY 2016

    1. Background

    2. Development of the FY 2016 LTCH PPS Standard Federal Rate

    B. Adjustment for Area Wage Levels Under the LTCH PPS Standard Federal Payment Rate for FY 2016

    1. Background

    2. Geographic Classifications (Labor Market Areas) for the LTCH PPS Standard Federal Payment Rate

    3. Labor-Related Share for the LTCH PPS Standard Federal Payment Rate

    4. Wage Index for FY 2016 for the LTCH PPS Standard Federal Payment Rate

    5. Budget Neutrality Adjustment for Changes to the LTCH PPS Standard Federal Payment Rate Area Wage Level Adjustment

    C. LTCH PPS Cost-of-Living Adjustment (COLA) for LTCHs Located in Alaska and Hawaii

    D. Adjustment for LTCH PPS High-Cost Outlier (HCO) Cases

    1. Overview

    2. Determining LTCH CCRs Under the LTCH PPS

    3. High-Cost Outlier Payments for LTCH PPS Standard Federal Payment Rate Cases

    4. High-Cost Outlier Payments for Site Neutral Payment Rate Cases

    E. Update to the IPPS Comparable/Equivalent Amounts To Reflect the Statutory Changes To the IPPS DSH Payment Adjustment Methodology

    F. Computing the Adjusted LTCH PPS Federal Prospective Payments for FY 2016

    VI. Tables Referenced in This Final Rule and Interim Final Rule With Comment Period and Available Through the Internet on the CMS Web site

    Appendix A--Economic Analyses

    I. Regulatory Impact Analysis

    A. Introduction

    B. Need

    C. Objectives of the IPPS

    D. Limitations of Our Analysis

    E. Hospitals Included in and Excluded From the IPPS

    F. Effects on Hospitals and Hospital Units Excluded From the IPPS

    G. Quantitative Effects of the Policy Changes Under the IPPS for Operating Costs

    1. Basis and Methodology of Estimates

    2. Analysis of Table I

    3. Impact Analysis of Table II

    H. Effects of Other Policy Changes

    1. Effects of Policy on MS-DRGs for Preventable HACs, Including Infections

    2. Effects of Policy Relating to New Medical Service and Technology Add-On Payments

    3. Effects of Changes in Medicare DSH Payments for FY 2016

    4. Effects of Reductions Under the Hospital Readmissions Reduction Program

    5. Effects of Changes Under the FY 2016 Hospital Value-Based Purchasing (VBP) Program

    6. Effects of Changes to the HAC Reduction Program for FY 2016

    7. Effects of Modification of the Simplified Cost Allocation Methodology

    8. Effects of Implementation of Rural Community Hospital Demonstration Program

    9. Effects of Changes to List of MS-DRGs Subject to Postacute Care Transfer and DRG Special Pay Policy

    I. Effects of Changes in the Capital IPPS

    1. General Considerations

    2. Results

    J. Effects of Payment Rate Changes and Policy Changes Under the LTCH PPS

    1. Introduction and General Considerations

    2. Impact on Rural Hospitals

    3. Anticipated Effects of LTCH PPS Payment Rate Changes and Policy Changes

    4. Effect on the Medicare Program

    5. Effect on Medicare Beneficiaries

    K. Effects of Requirements for Hospital Inpatient Quality Reporting (IQR) Program

    L. Effects of Requirements for the PPS-Exempt Cancer Hospital Quality Reporting (PCHQR) Program for FY 2016

    M. Effects of Requirements for the LTCH Quality Reporting Program (LTCH QRP) for FY 2016 Through FY 2020

    N. Effects of Changes to Clinical Quality Measurement for Eligible Hospitals and Critical Access Hospitals Participating in the EHR Incentive Programs in 2016

    II. Alternatives Considered

    III. Overall Conclusion

    A. Acute Care Hospitals

    B. LTCHs

    IV. Accounting Statements and Tables

    A. Acute Care Hospitals

    B. LTCHs

    V. Regulatory Flexibility Act (RFA) Analysis

    VI. Impact on Small Rural Hospitals

    VII. Unfunded Mandate Reform Act (UMRA) Analysis

    VIII. Executive Order 12866

    Appendix B: Recommendation of Update Factors for Operating Cost Rates of Payment for Inpatient Hospital Services

    I. Background

    II. Inpatient Hospital Updates for FY 2016

    A. FY 2016 Inpatient Hospital Update

    B. Update for SCHs and MDHs for FY 2016

    C. FY 2016 Puerto Rico Hospital Update

    D. Update for Hospitals Excluded From the IPPS for FY 2016

    E. Update for LTCHs for FY 2016

    III. Secretary's Recommendation

    Page 49334

    IV. MedPAC Recommendation for Assessing Payment Adequacy and Updating Payments in Traditional Medicare

    I. Executive Summary and Background

    A. Executive Summary

    1. Purpose and Legal Authority

    This final rule makes payment and policy changes under the Medicare inpatient prospective payment systems (IPPS) for operating and capital-

    related costs of acute care hospitals as well as for certain hospitals and hospital units excluded from the IPPS. In addition, it makes payment and policy changes for inpatient hospital services provided by long-term care hospitals (LTCHs) under the long-term care hospital prospective payment system (LTCH PPS). It also makes policy changes to programs associated with Medicare IPPS hospitals, IPPS-excluded hospitals, and LTCHs.

    This interim final rule with comment period implements the provisions of the Medicare Access and CHIP Reauthorization Act of 2015 which extended the MDH Program and changes to the low-volume payment adjustment for hospitals through FY 2017.

    Under various statutory authorities, we are making changes to the Medicare IPPS, to the LTCH PPS, and to other related payment methodologies and programs for FY 2016 and subsequent fiscal years. These statutory authorities include, but are not limited to, the following:

    Section 1886(d) of the Social Security Act (the Act), which sets forth a system of payment for the operating costs of acute care hospital inpatient stays under Medicare Part A (Hospital Insurance) based on prospectively set rates. Section 1886(g) of the Act requires that, instead of paying for capital-related costs of inpatient hospital services on a reasonable cost basis, the Secretary use a prospective payment system (PPS).

    Section 1886(d)(1)(B) of the Act, which specifies that certain hospitals and hospital units are excluded from the IPPS. These hospitals and units are: Rehabilitation hospitals and units; LTCHs; psychiatric hospitals and units; children's hospitals; cancer hospitals; and short-term acute care hospitals located in the Virgin Islands, Guam, the Northern Mariana Islands, and American Samoa. Religious nonmedical health care institutions (RNHCIs) are also excluded from the IPPS.

    Sections 123(a) and (c) of Public Law 106-113 and section 307(b)(1) of Public Law 106-554 (as codified under section 1886(m)(1) of the Act), which provide for the development and implementation of a prospective payment system for payment for inpatient hospital services of long-term care hospitals (LTCHs) described in section 1886(d)(1)(B)(iv) of the Act.

    Sections 1814(l), 1820, and 1834(g) of the Act, which specify that payments are made to critical access hospitals (CAHs) (that is, rural hospitals or facilities that meet certain statutory requirements) for inpatient and outpatient services and that these payments are generally based on 101 percent of reasonable cost.

    Section 1866(k) of the Act, as added by section 3005 of the Affordable Care Act, which establishes a quality reporting program for hospitals described in section 1886(d)(1)(B)(v) of the Act, referred to as ``PPS-Exempt Cancer Hospitals.''

    Section 1886(d)(4)(D) of the Act, which addresses certain hospital-acquired conditions (HACs), including infections. Section 1886(d)(4)(D) of the Act specifies that, by October 1, 2007, the Secretary was required to select, in consultation with the Centers for Disease Control and Prevention (CDC), at least two conditions that: (a) Are high cost, high volume, or both; (b) are assigned to a higher paying MS-DRG when present as a secondary diagnosis (that is, conditions under the MS-DRG system that are complications or comorbidities (CCs) or major complications or comorbidities (MCCs); and (c) could reasonably have been prevented through the application of evidence-based guidelines. Section 1886(d)(4)(D) of the Act also specifies that the list of conditions may be revised, again in consultation with CDC, from time to time as long as the list contains at least two conditions. Section 1886(d)(4)(D)(iii) of the Act requires that hospitals, effective with discharges occurring on or after October 1, 2007, submit information on Medicare claims specifying whether diagnoses were present on admission (POA). Section 1886(d)(4)(D)(i) of the Act specifies that effective for discharges occurring on or after October 1, 2008, Medicare no longer assigns an inpatient hospital discharge to a higher paying MS-DRG if a selected condition is not POA.

    Section 1886(a)(4) of the Act, which specifies that costs of approved educational activities are excluded from the operating costs of inpatient hospital services. Hospitals with approved graduate medical education (GME) programs are paid for the direct costs of GME in accordance with section 1886(h) of the Act. A payment for indirect medical education (IME) is made under section 1886(d)(5)(B) of the Act.

    Section 1886(b)(3)(B)(viii) of the Act, which requires the Secretary to reduce the applicable percentage increase in payments to a subsection (d) hospital for a fiscal year if the hospital does not submit data on measures in a form and manner, and at a time, specified by the Secretary.

    Section 1886(o) of the Act, which requires the Secretary to establish a Hospital Value-Based Purchasing (VBP) Program under which value-based incentive payments are made in a fiscal year to hospitals meeting performance standards established for a performance period for such fiscal year.

    Section 1886(p) of the Act, as added by section 3008 of the Affordable Care Act, which establishes an adjustment to hospital payments for hospital-acquired conditions (HACs), or a Hospital-

    Acquired Condition (HAC) Reduction Program, under which payments to applicable hospitals are adjusted to provide an incentive to reduce hospital-acquired conditions.

    Section 1886(q) of the Act, as added by section 3025 of the Affordable Care Act and amended by section 10309 of the Affordable Care Act, which establishes the ``Hospital Readmissions Reduction Program'' effective for discharges from an ``applicable hospital'' beginning on or after October 1, 2012, under which payments to those hospitals under section 1886(d) of the Act will be reduced to account for certain excess readmissions.

    Section 1886(r) of the Act, as added by section 3133 of the Affordable Care Act, which provides for a reduction to disproportionate share hospital payments under section 1886(d)(5)(F) of the Act and for a new uncompensated care payment to eligible hospitals. Specifically, section 1886(r) of the Act requires that, for fiscal year 2014 and each subsequent fiscal year, subsection (d) hospitals that would otherwise receive a disproportionate share hospital payment made under section 1886(d)(5)(F) of the Act will receive two separate payments: (1) 25 percent of the amount they previously would have received under section 1886(d)(5)(F) of the Act for DSH (``the empirically justified amount''), and (2) an additional payment for the DSH hospital's proportion of uncompensated care, determined as the product of three factors. These three factors are: (1) 75 percent of the payments that would otherwise be made under section 1886(d)(5)(F) of the Act; (2) 1 minus the percent change in the percent of individuals under the age of 65 who are uninsured (minus 0.1 percentage points for FY 2014, and minus 0.2 percentage points for FY 2015 through FY 2017);

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    and (3) a hospital's uncompensated care amount relative to the uncompensated care amount of all DSH hospitals expressed as a percentage.

    Section 1886(m)(6) of the Act, as added by section 1206(a)(1) of the Pathway for SGR Reform Act of 2013 (Pub. L. 113-67), which provided for the establishment of site neutral payment rate criteria under the LTCH PPS with implementation beginning in FY 2016.

    Section 1206(b)(1) of the Pathway for SGR Reform Act of 2013, which further amended section 114(c) of the MMSEA, as amended by section 4302(a) of the ARRA and sections 3106(c) and 10312(a) of the Affordable Care Act, by retroactively reestablishing and extending the statutory moratorium on the full implementation of the 25-percent threshold payment adjustment policy under the LTCH PPS so that the policy will be in effect for 9 years (except for ``grandfathered'' hospital-within-hospitals (HwHs), which are permanently exempt from this policy); and section 1206(b)(2) (as amended by section 112(b) of Pub. L. 113-93), which together further amended section 114(d) of the MMSEA, as amended by section 4302(a) of the ARRA and sections 3106(c) and 10312(a) of the Affordable Care Act to establish a new moratoria (subject to certain defined exceptions) on the development of new LTCHs and LTCH satellite facilities and a new moratorium on increases in the number of beds in existing LTCHs and LTCH satellite facilities beginning January 1, 2015 and ending on September 30, 2017; and section 1206(d), which instructs the Secretary to evaluate payments to LTCHs classified under section 1886(b)(1)(C)(iv)(II) of the Act and to adjust payment rates in FY 2015 or FY 2016 under the LTCH PPS, as appropriate, based upon the evaluation findings.

    Section 1886(m)(5)(D)(iv) of the Act, as added by section 1206(c) of the Pathway for SGR Reform Act of 2013, which provides for the establishment, no later than October 1, 2015, of a functional status quality measure under the LTCH QRP for change in mobility among inpatients requiring ventilator support.

    Section 1899B of the Act, as added by the Improving Medicare Post-Acute Care Transformation Act of 2014 (the IMPACT Act of 2014), which imposes new data reporting requirements for certain postacute care providers, including LTCHs.

    Section 1886(d)(12) of the Act, as amended by section 204 of the Medicare Access and CHIP Reauthorization Act of 2015, which extended, through FY 2017, changes to the inpatient hospital payment adjustment for certain low-volume hospitals; and section 1886(d)(5)(G) of the Act, as amended by section 205 of the Medicare Access and CHIP Reauthorization Act of 2015, which extended, through FY 2017, the Medicare-dependent, small rural hospital (MDH) program.

    2. Summary of the Major Provisions

  177. MS-DRG Documentation and Coding Adjustment

    Section 631 of the American Taxpayer Relief Act (ATRA, Pub. L. 112-

    240) amended section 7(b)(1)(B) of Public Law 110-90 to require the Secretary to make a recoupment adjustment to the standardized amount of Medicare payments to acute care hospitals to account for changes in MS-

    DRG documentation and coding that do not reflect real changes in case-

    mix, totaling $11 billion over a 4-year period of FYs 2014, 2015, 2016, and 2017. This adjustment represents the amount of the increase in aggregate payments as a result of not completing the prospective adjustment authorized under section 7(b)(1)(A) of Public Law 110-90 until FY 2013. Prior to the ATRA, this amount could not have been recovered under Public Law 110-90.

    While our actuaries estimated that a -9.3 percent adjustment to the standardized amount would be necessary if CMS were to fully recover the $11 billion recoupment required by section 631 of the ATRA in one year, it is often our practice to delay or phase in rate adjustments over more than one year, in order to moderate the effects on rates in any one year. Therefore, consistent with the policies that we have adopted in many similar cases, we made a -0.8 percent recoupment adjustment to the standardized amount in FY 2014 and FY 2015. For FY 2016, we are making an additional -0.8 percent recoupment adjustment to the standardized amount.

  178. Reduction of Hospital Payments for Excess Readmissions

    We are making changes in policies to the Hospital Readmissions Reduction Program, which is established under section 1886(q) of the Act, as added by section 3025 of the Affordable Care Act. The Hospital Readmissions Reduction Program requires a reduction to a hospital's base operating DRG payment to account for excess readmissions of selected applicable conditions. For FYs 2013 and 2014, these conditions are acute myocardial infarction, heart failure, and pneumonia. For FY 2014, we established additional exclusions to the three existing readmission measures (that is, the excess readmission ratio) to account for additional planned readmissions. We also established additional readmissions measures, chronic obstructive pulmonary disease (COPD), and total hip arthroplasty and total knee arthroplasty (THA/TKA), to be used in the Hospital Readmissions Reduction Program for FY 2015 and future years. We expanded the readmissions measures for FY 2017 and future years by adding a measure of patients readmitted following coronary artery bypass graft (CABG) surgery.

    In this final rule, we are making a refinement to the pneumonia readmissions measure, which expands the measure cohort for the FY 2017 payment determination and subsequent years. Specifically, we are finalizing a modified version of the expanded pneumonia cohort from what we had specified in the FY 2016 IPPS/LTCH PPS proposed rule such that the modified version includes patients with a principal discharge diagnosis of pneumonia or aspiration pneumonia, and patients with a principal discharge diagnosis of sepsis with a secondary diagnosis of pneumonia coded as present on admission. However, we are not including patients with a principal discharge diagnosis of respiratory failure or patients with a principal discharge diagnosis of sepsis if they are coded as having severe sepsis as we had previously proposed. In addition, we are adopting an extraordinary circumstance exception policy that will align with existing extraordinary circumstance exception policies for other IPPS quality reporting and payment programs and will allow hospitals that experience an extraordinary circumstance (such as a hurricane or flood) to request a waiver for use of data from the affected time period.

  179. Hospital Value-Based Purchasing (VBP) Program

    Section 1886(o) of the Act requires the Secretary to establish a Hospital VBP Program under which value-based incentive payments are made in a fiscal year to hospitals based on their performance on measures established for a performance period for such fiscal year.

    For FY 2016, we are adopting one additional measure beginning with the FY 2018 program year and one measure beginning with the FY 2021 program year. We also are removing two measures beginning with the FY 2018 program year. In addition, we are moving one measure to the Safety domain and removing the Clinical Care--Process subdomain and renaming the Clinical Care--Outcomes subdomain

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    as the Clinical Care domain. Finally, we are signaling our intent to propose in future rulemaking to expand one measure and to update the standard population data we use to calculate several measures beginning with the FY 2019 program year.

  180. Hospital-Acquired Condition (HAC) Reduction Program

    Section 1886(p) of the Act, as added under section 3008(a) of the Affordable Care Act, establishes an incentive to hospitals to reduce the incidence of hospital-acquired conditions by requiring the Secretary to make an adjustment to payments to applicable hospitals effective for discharges beginning on October 1, 2014 and for subsequent program years. This 1-percent payment reduction applies to a hospital whose ranking is in the top quartile (25 percent) of all applicable hospitals, relative to the national average, of conditions acquired during the applicable period and on all of the hospital's discharges for the specified fiscal year. The amount of payment shall be equal to 99 percent of the amount of payment that would otherwise apply to such discharges under section 1886(d) or 1814(b)(3) of the Act, as applicable.

    In this final rule, we are making three changes to existing Hospital-Acquired Condition Reduction Program policies: (1) An expansion to the population covered by the central line-associated bloodstream infection (CLABSI) and catheter-associated urinary tract infection (CAUTI) measures to include patients in select nonintensive care unit sites within a hospital; (2) an adjustment to the relative contribution of each domain to the Total HAC Score which is used to determine if a hospital will receive the payment adjustment; and (3) a policy that will align with existing extraordinary circumstance exception policies for other IPPS quality reporting and payment programs and will allow hospitals to request a waiver for use of data from the affected time period.

  181. DSH Payment Adjustment and Additional Payment for Uncompensated Care

    Section 3133 of the Affordable Care Act modified the Medicare disproportionate share hospital (DSH) payment methodology beginning in FY 2014. Under section 1886(r) of the Act, which was added by section 3133 of the Affordable Care Act, starting in FY 2014, DSHs will receive 25 percent of the amount they previously would have received under the statutory formula for Medicare DSH payments in section 1886(d)(5)(F) of the Act. The remaining amount, equal to 75 percent of what otherwise would have been paid as Medicare DSH payments, will be paid as additional payments after the amount is reduced for changes in the percentage of individuals that are uninsured. Each Medicare DSH hospital will receive an additional payment based on its share of the total amount of uncompensated care for all Medicare DSH hospitals for a given time period.

    In this final rule, we are updating our estimates of the three factors used to determine uncompensated care payments for FY 2016. We are continuing to use the methodology we established in FY 2015 to calculate the uncompensated care payment amounts for merged hospitals such that we combine uncompensated care data for the hospitals that have undergone a merger in order to calculate their relative share of uncompensated care. We also are changing the time period of the data used to calculate the uncompensated care payment amounts to be distributed.

  182. Changes to the LTCH PPS

    Under the current LTCH PPS, all discharges are paid under the LTCH PPS standard Federal payment rate. In this final rule, we are implementing section 1206 of the Pathway for SGR Reform Act, which requires the establishment of an alternative site neutral payment rate for Medicare discharges from an LTCH that fail to meet certain statutory defined criteria, beginning with LTCH discharges occurring in cost reporting periods beginning on or after October 1, 2015. We include provisions regarding the application of the site neutral payment rate and the criteria for exclusion from the site neutral payment rate, as well as provisions on a number of methodological and implementation issues, such as the criterion for a principal diagnosis relating to a psychiatric diagnosis or to rehabilitation, the intensive care unit (ICU) criterion, the ventilator criterion, the definition of ``immediately preceded'' by a subsection (d) hospital discharge, limitation on beneficiary charges in the context of the new site neutral payment rate, and the transitional blended payment rate methodology for FY 2016 and FY 2017.

    In addition, we are making changes to address certain statutory requirements related to an LTCH's average length of stay criterion and discharge payment percentage. We also are providing technical clarifications relating to our FY 2015 implementation of the new statutory moratoria on the establishment of new LTCHs and LTCH satellite facilities (subject to certain defined exceptions) and on bed increases in existing LTCHs and LTCH satellite facilities as well as making a technical revision to the regulations to more clearly reflect our established policies.

  183. Hospital Inpatient Quality Reporting (IQR) Program

    Under section 1886(b)(3)(B)(viii) of the Act, hospitals are required to report data on measures selected by the Secretary for the Hospital IQR Program in order to receive the full annual percentage increase in payments. In past years, we have established measures for reporting data and the process for submittal and validation of the data.

    In this final rule, we are updating considerations for measure removal and retention. In addition, we are removing nine chart-

    abstracted measures for the FY 2018 payment determination and subsequent years: Six of these measures are ``topped-out'' (STK-01, STK-06, STK-08, VTE-1, VTE-2, and VTE-3) and two of the measures are suspended (IMM-1 and SCIP-Inf-4). However, we are retaining the electronic versions of five of the chart-abstracted measures finalized for removal.

    We are refining two previously adopted measures for the FY 2018 payment determination and subsequent years. We are also adding seven new measures: Three new claims-based measures and one structural measure for the FY 2018 payment determination and subsequent years; and three new claims-based measures for the FY 2019 payment determination and subsequent years.

    Further, for the FY 2018 payment determination, we are requiring hospitals to report a minimum of 4 electronic clinical quality measures. Under this modification to our proposal, no NQS domain distribution will be required. We are requiring that hospitals submit one quarter of electronic clinical quality measure data from either Q3 or Q4 of CY 2016 with a submission deadline of February 28, 2017. For the reporting of electronic clinical quality measures, hospitals may be certified either to the CEHRT 2014 or 2015 Edition, but must submit using the QRDA I format. We plan to finalize public reporting of electronic data in next year's rulemaking after the conclusion and assessment of the validation pilot. Six previously adopted measures (ED-1, ED-2, PC-01, STK-04, VTE-5, and VTE-6) must still be submitted via chart-abstraction regardless of whether they are also submitted as electronic clinical quality measures. We are also continuing our policy regarding STK-01 to clarify that

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    hospitals need not report the STK-01 measure as part of the STK measure set if reporting electronically, because no electronic specification existed for STK-01. Beginning with the FY 2018 payment determination, we are expanding our previously established extraordinary circumstances extensions/exemptions policy (79 FR 50277) to allow hospitals to utilize the existing Extraordinary Circumstances Exception (ECE) form to request exemptions based on hardships in reporting eCQMs.

    Finally, we are modifying the existing processes for validation of chart-abstracted Hospital IQR Program data to remove one stratum.

  184. Long-Term Care Quality Reporting Program (LTCH QRP)

    Section 3004(a) of the Affordable Care Act amended section 1886(m)(5) of the Act to require the Secretary to establish the Long-

    Term Care Hospital Quality Reporting Program (LTCH QRP). This program applies to all hospitals certified by Medicare as LTCHs. Beginning with the FY 2014 payment determination and subsequent years, the Secretary is required to reduce any annual update to the standard Federal rate for discharges occurring during such fiscal year by 2 percentage points for any LTCH that does not comply with the requirements established by the Secretary.

    The IMPACT Act of 2014 amended the Act in ways that affect the LTCH QRP. Specifically, section 2(a) of the IMPACT Act of 2014 added section 1899B of the Act, and section 2(c)(3) of the IMPACT Act of 2014 amended section 1886(m)(5) of the Act. Under section 1899B(a)(1) of the Act, the Secretary must require post-acute care (PAC) providers (defined in section 1899B(a)(2)(A) of the Act to include HHAs, SNFs, IRFs, and LTCHs) to submit standardized patient assessment data in accordance with section 1899B(b) of the Act, data on quality measures required under section 1899B(c)(1) of the Act, and data on resource use and other measures required under section 1899B(d)(1) of the Act. The Act also sets out specified application dates for each of the measures. The Secretary must specify the quality, resource use, and other measures not later than the applicable specified application date defined in section 1899B(a)(2)(E) of the Act.

    In this final rule, we are establishing three previously finalized quality measures: One measure establishes the newly NQF-endorsed status of that quality measure; two other measures are for the purpose of establishing the cross-setting use of the previously finalized quality measures, in order to satisfy the IMPACT Act of 2014 requirement of adopting quality measures under the domains of skin integrity and falls with major injury. We are adopting an application of a fourth previously finalized LTCH functional status measure in order to meet the requirement of the IMPACT Act of 2014 to adopt a cross-setting measure under the domain of functional status, such as self-care or mobility. All four measures effect the FY 2018 annual payment update determination and beyond.

    In addition, we will publicly report LTCH quality data beginning in fall 2016, on a CMS Web site, such as Hospital Compare. We will initially publicly report quality data on four quality measures.

    Finally, we are lengthening our quarterly data submission deadlines from 45 days to 135 days beyond the end of each calendar year quarter beginning with quarter four (4) 2015 quality data. We are making this change in order to align with other quality reporting programs, and to allow an appropriate amount of time for LTCHs to review and correct quality data prior to the public posting of that data.

    3. Summary of Costs and Benefits

    Adjustment for MS-DRG Documentation and Coding Changes. We are making a -0.8 percent recoupment adjustment to the standardized amount for FY 2016 to implement, in part, the requirement of section 631 of the ATRA that the Secretary make an adjustment totaling $11 billion over a 4-year period of FYs 2014, 2015, 2016, and 2017. This recoupment adjustment represents the amount of the increase in aggregate payments as a result of not completing the prospective adjustment authorized under section 7(b)(1)(A) of Public Law 110-90 until FY 2013. Prior to the ATRA, this amount could not have been recovered under Public Law 110-90.

    While our actuaries estimated that a -9.3 percent recoupment adjustment to the standardized amount would be necessary if CMS were to fully recover the $11 billion recoupment required by section 631 of the ATRA in FY 2014, it is often our practice to delay or phase in rate adjustments over more than one year, in order to moderate the effects on rates in any one year. Therefore, consistent with the policies that we have adopted in many similar cases and the adjustment we made for FY 2014, we are making a -0.8 percent recoupment adjustment to the standardized amount in FY 2016. Taking into account the cumulative effects of this adjustment and the adjustments made in FYs 2014 and 2015, we currently estimate that approximately $5 to $6 billion would be left to recover under section 631 of the ATRA by the end of FY 2016. We have not yet addressed the specific amount of the final adjustment required under section 631 of the ATRA for FY 2017. We intend to address this adjustment in the FY 2017 IPPS rulemaking. However, we note that section 414 of the MACRA (Pub. L. 114-10), enacted on April 16, 2015, replaced the single positive adjustment we intended to make in FY 2018 with a 0.5 percent positive adjustment for each of FYs 2018 through 2023. The provision under section 414 of the MACRA does not impact our FY 2016 recoupment adjustment, and we will address this MACRA provision in future rulemaking.

    Changes to the Hospital Readmissions Reduction Program. We are making a refinement to the pneumonia readmissions measure, which will expand the measure cohort for the FY 2017 payment determination and subsequent years. In addition, we are adopting an extraordinary circumstance exception policy that will align with existing extraordinary circumstance exception policies for other IPPS quality reporting and payment programs and will allow hospitals that experience an extraordinary circumstance (such as a hurricane or flood) to request a waiver for use of data from the affected time period. These changes will not significantly impact the program in FY 2016, but could impact future years, depending on actual experience.

    Overall, in this final rule, we estimate that 2,666 hospitals will have their base operating DRG payments reduced by their proxy FY 2016 hospital-specific readmissions adjustment. As a result, we estimate that the Hospital Readmissions Reduction Program will save approximately $420 million in FY 2016, an increase of $6 million over the estimated FY 2015 savings.

    Value-Based Incentive Payments under the Hospital VBP Program. We estimate that there will be no net financial impact to the Hospital VBP Program for the FY 2016 program year in the aggregate because, by law, the amount available for value-based incentive payments under the program in a given year must be equal to the total amount of base operating MS-DRG payment amount reductions for that year, as estimated by the Secretary. The estimated amount of base operating MS-DRG payment amount reductions for the FY 2016 program year and, therefore, the estimated amount available for value-based incentive payments for FY

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    2016 discharges is approximately $1.5 billion.

    Changes to the HAC Reduction Program for FY 2016. We are making three changes to existing HAC Reduction Program policies: (1) An expansion to the population covered by the central line-associated bloodstream infection (CLABSI) and catheter-associated urinary tract infection (CAUTI) measures to include patients in select nonintensive care unit sites within a hospital; (2) an adjustment to the relative contribution of each domain to the Total HAC Score that is used to determine if a hospital will receive the payment adjustment; and (3) a policy that will align with existing extraordinary circumstance exception policies for other IPPS quality reporting and payment programs and will allow hospitals to request a waiver for use of data from the affected period. Hospitals in the top quartile of HAC scores will continue to have their HAC Reduction Program payment adjustment applied, as required by law. However, because a hospital's Total HAC score and its ranking in comparison to other hospitals in any given year depend on several different factors, any significant impact due to the HAC Reduction Program changes for FY 2016, including which hospitals receive the adjustment, will depend on actual experience.

    Medicare DSH Payment Adjustment and Additional Payment for Uncompensated Care. Under section 1886(r) of the Act (as added by section 3313 of the Affordable Care Act), disproportionate share hospital payments to hospitals under section 1886(d)(5)(F) of the Act are reduced and an additional payment for uncompensated care is made to eligible hospitals beginning in FY 2014. Hospitals that receive Medicare DSH payments will receive 25 percent of the amount they previously would have received under the current statutory formula for Medicare DSH payments in section 1886(d)(5)(F) of the Act. The remainder, equal to an estimate of 75 percent of what otherwise would have been paid as Medicare DSH payments, will be the basis for determining the additional payments for uncompensated care after the amount is reduced for changes in the percentage of individuals that are uninsured and additional statutory adjustments. Each hospital that receives Medicare DSH payments will receive an additional payment for uncompensated care based on its share of the total uncompensated care amount reported by Medicare DSHs. The reduction to Medicare DSH payments is not budget neutral.

    For FY 2016, we are providing that the 75 percent of what otherwise would have been paid for Medicare DSH is adjusted to approximately 63.69 percent of the amount to reflect changes in the percentage of individuals that are uninsured and additional statutory adjustments. In other words, approximately 47.76 percent (the product of 75 percent and 63.69 percent) of our estimate of Medicare DSH payments prior to the application of section 3133 of the Affordable Care Act is available to make additional payments to hospitals for their relative share of the total amount of uncompensated care. We project that Medicare DSH payments and additional payments for uncompensated care made for FY 2016 will reduce payments overall by approximately 1 percent as compared to the Medicare DSH payments and uncompensated care payments distributed in FY 2015. The additional payments have redistributive effects based on a hospital's uncompensated care amount relative to the uncompensated care amount for all hospitals that are estimated to receive Medicare DSH payments, and the payment amount is not directly tied to a hospital's number of discharges.

    Implementation of Legislative Extensions Relating to the Payment Adjustment for Low-Volume Hospitals and the Medicare-Dependent, Small Rural Hospital Program. The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10) extended certain provisions relating to the payment adjustment for low-volume hospitals under section 1886(d)(12) of the Act and extended the Medicare-

    dependent, small rural hospital (MDH) Program. Section 204 of the MACRA extended the temporary changes to the low-volume hospital qualifying criteria and payment adjustment for IPPS hospital discharges occurring on or after April 1, 2015 through September 30, 2017. Section 205 of the MACRA extended the MDH program for IPPS hospital discharges occurring on or after April 1, 2015 through September 30, 2017. We project that IPPS payments for FY 2016 will increase by approximately $322 million as a result of the statutory extensions of certain provisions of the low-volume hospital payment adjustment and approximately $96 million for the MDH program compared to such payments in absence of these extensions.

    Update to the LTCH PPS Payment Rates and Other Payment Factors. Based on the best available data for the 419 LTCHs in our data base, we estimate that the changes to the payment rates and factors that we are presenting in the preamble and Addendum of this final rule, including the application of the new site neutral payment rate required by section 1886(m)(6)(A) of the Act, the update to the LTCH PPS standard Federal payment rate for FY 2016, and the changes to short-

    stay outlier and high-cost outlier payments will result in an estimated decrease in payments from FY 2015 of approximately $250 million.

    Hospital Inpatient Quality Reporting (IQR) Program. In this final rule, we are removing nine measures for the FY 2018 payment determination and subsequent years. We are adding seven measures to the Hospital IQR Program for the payment determination; four for the FY 2018 payment determination and subsequent years and three for FY 2019 payment determination and subsequent years. We also are requiring hospitals to report 4 of the 28 Hospital IQR Program electronic clinical quality measures that align with the Medicare EHR Incentive Program. We estimate that our policies for the adoption and removal of measures will result in total hospital costs of $169 million across 3,300 IPPS hospitals.

    Changes in LTCH Payments Related to the LTCH QRP Proposals. We believe that the increase in costs to LTCHs related to our LTCH QRP policies in this final rule is zero. We refer readers to sections VIII.C. of the preamble of this final rule for detailed discussion of the policies.

    B. Summary

    1. Acute Care Hospital Inpatient Prospective Payment System (IPPS)

    Section 1886(d) of the Social Security Act (the Act) sets forth a system of payment for the operating costs of acute care hospital inpatient stays under Medicare Part A (Hospital Insurance) based on prospectively set rates. Section 1886(g) of the Act requires the Secretary to use a prospective payment system (PPS) to pay for the capital-related costs of inpatient hospital services for these ``subsection (d) hospitals.'' Under these PPSs, Medicare payment for hospital inpatient operating and capital-related costs is made at predetermined, specific rates for each hospital discharge. Discharges are classified according to a list of diagnosis-related groups (DRGs).

    The base payment rate is comprised of a standardized amount that is divided into a labor-related share and a nonlabor-related share. The labor-related share is adjusted by the wage index applicable to the area where the hospital is located. If the hospital is located in Alaska or Hawaii, the nonlabor-related share is adjusted by a cost-of-

    living adjustment factor. This

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    base payment rate is multiplied by the DRG relative weight.

    If the hospital treats a high percentage of certain low-income patients, it receives a percentage add-on payment applied to the DRG-

    adjusted base payment rate. This add-on payment, known as the disproportionate share hospital (DSH) adjustment, provides for a percentage increase in Medicare payments to hospitals that qualify under either of two statutory formulas designed to identify hospitals that serve a disproportionate share of low-income patients. For qualifying hospitals, the amount of this adjustment varies based on the outcome of the statutory calculations. The Affordable Care Act revised the Medicare DSH payment methodology and provided for a new additional Medicare payment that considers the amount of uncompensated care provided by the hospital. Payment under this methodology began in FY 2014.

    If the hospital is an approved teaching hospital, it receives a percentage add-on payment for each case paid under the IPPS, known as the indirect medical education (IME) adjustment. This percentage varies, depending on the ratio of residents to beds.

    Additional payments may be made for cases that involve new technologies or medical services that have been approved for special add-on payments. To qualify, a new technology or medical service must demonstrate that it is a substantial clinical improvement over technologies or services otherwise available, and that, absent an add-

    on payment, it would be inadequately paid under the regular DRG payment.

    The costs incurred by the hospital for a case are evaluated to determine whether the hospital is eligible for an additional payment as an outlier case. This additional payment is designed to protect the hospital from large financial losses due to unusually expensive cases. Any eligible outlier payment is added to the DRG-adjusted base payment rate, plus any DSH, IME, and new technology or medical service add-on adjustments.

    Although payments to most hospitals under the IPPS are made on the basis of the standardized amounts, some categories of hospitals are paid in whole or in part based on their hospital-specific rate, which is determined from their costs in a base year. For example, sole community hospitals (SCHs) receive the higher of a hospital-specific rate based on their costs in a base year (the highest of FY 1982, FY 1987, FY 1996, or FY 2006) or the IPPS Federal rate based on the standardized amount. SCHs are the sole source of care in their areas. Specifically, section 1886(d)(5)(D)(iii) of the Act defines an SCH as a hospital that is located more than 35 road miles from another hospital or that, by reason of factors such as isolated location, weather conditions, travel conditions, or absence of other like hospitals (as determined by the Secretary), is the sole source of hospital inpatient services reasonably available to Medicare beneficiaries. In addition, certain rural hospitals previously designated by the Secretary as essential access community hospitals are considered SCHs.

    We note that the Medicare Access and CHIP Reauthorization Act of 2015 (Pub. L. 114-10), enacted on April 16, 2015, extended the Medicare-dependent, small rural hospital (MDH) program through FY 2017. Through and including FY 2006, an MDH received the higher of the Federal rate or the Federal rate plus 50 percent of the amount by which the Federal rate was exceeded by the higher of its FY 1982 or FY 1987 hospital-specific rate. For discharges occurring on or after October 1, 2007, through FY 2017, an MDH receives the higher of the Federal rate or the Federal rate plus 75 percent of the amount by which the Federal rate is exceeded by the highest of its FY 1982, FY 1987, or FY 2002 hospital-specific rate. MDHs are a major source of care for Medicare beneficiaries in their areas. Section 1886(d)(5)(G)(iv) of the Act defines an MDH as a hospital that is located in a rural area, has no more than 100 beds, is not an SCH, and has a high percentage of Medicare discharges (not less than 60 percent of its inpatient days or discharges in its cost reporting year beginning in FY 1987 or in two of its three most recently settled Medicare cost reporting years).

    Section 1886(g) of the Act requires the Secretary to pay for the capital-related costs of inpatient hospital services ``in accordance with a prospective payment system established by the Secretary.'' The basic methodology for determining capital prospective payments is set forth in our regulations at 42 CFR 412.308 and 412.312. Under the capital IPPS, payments are adjusted by the same DRG for the case as they are under the operating IPPS. Capital IPPS payments are also adjusted for IME and DSH, similar to the adjustments made under the operating IPPS. In addition, hospitals may receive outlier payments for those cases that have unusually high costs.

    The existing regulations governing payments to hospitals under the IPPS are located in 42 CFR part 412, subparts A through M.

    2. Hospitals and Hospital Units Excluded From the IPPS

    Under section 1886(d)(1)(B) of the Act, as amended, certain hospitals and hospital units are excluded from the IPPS. These hospitals and units are: Rehabilitation hospitals and units; long-term care hospitals (LTCHs); psychiatric hospitals and units; children's hospitals; certain cancer hospitals; and short-term acute care hospitals located in Guam, the U.S. Virgin Islands, the Northern Mariana Islands, and American Samoa. Religious nonmedical health care institutions (RNHCIs) are also excluded from the IPPS. Various sections of the Balanced Budget Act of 1997 (BBA, Pub. L. 105-33), the Medicare, Medicaid and SCHIP State Children's Health Insurance Program Balanced Budget Refinement Act of 1999 (BBRA, Pub. L. 106-113), and the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA, Pub. L. 106-554) provide for the implementation of PPSs for rehabilitation hospitals and units (referred to as inpatient rehabilitation facilities (IRFs)), LTCHs, and psychiatric hospitals and units (referred to as inpatient psychiatric facilities (IPFs)). (We note that the annual updates to the LTCH PPS are now included as part of the IPPS annual update document. Updates to the IRF PPS and IPF PPS are issued as separate documents.) Children's hospitals, certain cancer hospitals, short-term acute care hospitals located in Guam, the U.S. Virgin Islands, the Northern Mariana Islands, and American Samoa, and RNHCIs continue to be paid solely under a reasonable cost-based system subject to a rate-of-increase ceiling on inpatient operating costs, as updated annually by the percentage increase in the IPPS operating market basket.

    The existing regulations governing payments to excluded hospitals and hospital units are located in 42 CFR parts 412 and 413.

    3. Long-Term Care Hospital Prospective Payment System (LTCH PPS)

    The Medicare prospective payment system (PPS) for LTCHs applies to hospitals described in section 1886(d)(1)(B)(iv) of the Act effective for cost reporting periods beginning on or after October 1, 2002. The LTCH PPS was established under the authority of section 123 of the BBRA and section 307(b) of the BIPA (as codified under section 1886(m)(1) of the Act). During the 5-year (optional) transition period, a LTCH's payment under the PPS was based on an increasing proportion of the LTCH Federal rate with a corresponding

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    decreasing proportion based on reasonable cost principles. Effective for cost reporting periods beginning on or after October 1, 2006, all LTCHs are paid 100 percent of the Federal rate. Section 1206(a) of Public Law 113-67 established the site neutral payment rate under the LTCH PPS. Under this statute, based on a rolling effective date that is linked to the date on which a given LTCH's Federal FY 2016 cost reporting period begins, LTCHs will be paid for LTCH discharges at the new site neutral payment rate unless the discharge meets the patient criteria for payment at the LTCH PPS standard Federal payment rate. The existing regulations governing payment under the LTCH PPS are located in 42 CFR part 412, subpart O.

    4. Critical Access Hospitals (CAHs)

    Under sections 1814(l), 1820, and 1834(g) of the Act, payments made to critical access hospitals (CAHs) (that is, rural hospitals or facilities that meet certain statutory requirements) for inpatient and outpatient services are generally based on 101 percent of reasonable cost. Reasonable cost is determined under the provisions of section 1861(v)(1)(A) of the Act and existing regulations under 42 CFR part 413.

    5. Payments for Graduate Medical Education (GME)

    Under section 1886(a)(4) of the Act, costs of approved educational activities are excluded from the operating costs of inpatient hospital services. Hospitals with approved graduate medical education (GME) programs are paid for the direct costs of GME in accordance with section 1886(h) of the Act. The amount of payment for direct GME costs for a cost reporting period is based on the hospital's number of residents in that period and the hospital's costs per resident in a base year. The existing regulations governing payments to the various types of hospitals are located in 42 CFR part 413.

    C. Summary of Provisions of Recent Legislation Discussed in This Final Rule

    The American Taxpayer Relief Act of 2012 (ATRA) (Pub. L. 112-240), enacted on January 2, 2013, made a number of changes that affect the IPPS. We announced changes related to certain IPPS provisions for FY 2013 in accordance with sections 605 and 606 of Public Law 112-240 in a notice that appeared in the Federal Register on March 7, 2013 (78 FR 14689).

    The Pathway for SGR Reform Act of 2013 (Pub. L. 113-67), enacted on December 26, 2013, also made a number of changes that affect the IPPS and the LTCH PPS. We implemented changes related to the low-volume hospital payment adjustment and MDH provisions for FY 2014 in accordance with sections 1105 and 1106 of Public Law 113-67 in an interim final rule with comment period that appeared in the Federal Register on March 18, 2014 (79 FR 15022).

    The Protecting Access to Medicare Act of 2014 (Pub. L. 113-93), enacted on April 1, 2014, also made a number of changes that affect the IPPS and LTCH PPS.

    The Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act of 2014) (Pub. L. 113-185), enacted on October 6, 2014, made a number of changes that affect the Long-Term Care Quality Reporting Program (LTCH QRP).

    The Medicare Access and CHIP Reauthorization Act of 2015 (Pub. L. 114-10) enacted on April 16, 2015, extended the MDH program and changes to the payment adjustment for low-volume hospitals through FY 2017.

    1. American Taxpayer Relief Act of 2012 (ATRA) (Pub. L. 112-240)

    In this final rule, we are making policy changes to implement section 631 of the American Taxpayer Relief Act of 2012, which amended section 7(b)(1)(B) of Public Law 110-90 and requires a recoupment adjustment to the standardized amounts under section 1886(d) of the Act based upon the Secretary's estimates for discharges occurring in FY 2014 through FY 2017 to fully offset $11 billion (which represents the amount of the increase in aggregate payments from FYs 2008 through 2013 for which an adjustment was not previously applied).

    2. Pathway for SGR Reform Act of 2013 (Pub. L. 113-67)

    In this final rule, we are providing clarifications to prior policy changes, making new policy changes, and discussing the need for future policy changes to implement provisions under section 1206 of the Pathway for SGR Reform Act of 2013. These include:

    Section 1206(a), which provides for the establishment of patient criteria for exclusion from the new site neutral payment rate under the LTCH PPS, beginning in FY 2016.

    Section 1206(a)(3), which requires changes to the LTCH average length of stay criterion.

    Section 1206(b)(1), which further amended section 114(c) of the MMSEA, as amended by section 4302(a) of the ARRA and sections 3106(c) and 10312(a) of the Affordable Care Act by retroactively reestablishing, and extending, the statutory moratorium on the full implementation of the 25-percent threshold payment adjustment policy under the LTCH PPS so that the policy will be in effect for 9 years (except for grandfathered hospitals-within-hospitals (HwHs), which it permanently exempted from this policy).

    Section 1206(b)(2), which amended section 114(d) of the MMSEA, as amended by section 4302(a) of the ARRA and sections 3106(c) and 10312(a) of the Affordable Care Act to establish new moratoria (subject to certain defined exceptions) on the development of new LTCHs and LTCH satellite facilities and a new moratorium on increases in the number of beds in existing LTCHs and LTCH satellite facilities.

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

    In this final rule, we are clarifying or discussing our prior policy changes that implemented the following provisions (or portions of the following provisions) of the Protecting Access to Medicare Act of 2014 that are applicable to the IPPS and the LTCH PPS for FY 2016:

    Section 112, which makes certain changes to Medicare LTCH provisions, including modifications to the statutory moratoria on the establishment of new LTCHs and LTCH satellite facilities.

    Section 212, which prohibits the Secretary from requiring implementation of ICD-10 code sets before October 1, 2015.

    4. Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act of 2014) (Pub. L. 113-185)

    In this final rule, we are implementing portions of section 2 of the IMPACT Act of 2014, which, in part, requires LTCHs, among other postacute care providers, to report standardized patient assessment data, data on quality measures, and data on resource use and other measures.

    5. The Medicare Access and CHIP Reauthorization Act of 2015 (Pub. L. 114-10)

    In this document, as an interim final rule with comment period, we are implementing sections 204 and 205 of the Medicare Access and CHIP Reauthorization Act of 2015, which extended the MDH program and changes to the low-volume payment adjustment for hospitals through FY 2017.

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    D. Issuance of Notice of Proposed Rulemaking

    Earlier this year, we published a proposed rule that set forth proposed changes for the Medicare IPPS for operating costs and for capital-related costs of acute care hospitals for FY 2016. The proposed rule appeared in the Federal Register on April 30, 2015 (80 FR 24324). We also set forth proposed changes to payments to certain hospitals that continue to be excluded from the IPPS and paid on a reasonable cost basis. In addition, in the proposed rule, we set forth proposed changes to the payment rates, factors, and other payment rate policies under the LTCH PPS for FY 2016.

    Below is a summary of the major changes that we proposed to make.

    1. Proposed Changes to MS-DRG Classifications and Recalibrations of Relative Weights

    In section II. of the preamble of the proposed rule, we included--

    Proposed changes to MS-DRG classifications based on our yearly review, including a discussion of the conversion of MS-DRGs to ICD-10 and the implementation of the ICD-10-CM and ICD-10-PCS systems.

    Proposed application of the documentation and coding adjustment for FY 2016 resulting from implementation of the MS-DRG system.

    Proposed recalibrations of the MS-DRG relative weights.

    Proposed changes to hospital-acquired conditions (HACs) and a discussion of HACs, including infections, that would be subject to the statutorily required adjustment in MS-DRG payments for FY 2016.

    A discussion of the FY 2016 status of new technologies approved for add-on payments for FY 2015 and a presentation of our evaluation and analysis of the FY 2016 applicants for add-on payments for high-cost new medical services and technologies (including public input, as directed by Pub. L. 108-173, obtained in a town hall meeting).

    2. Proposed Changes to the Hospital Wage Index for Acute Care Hospitals

    In section III. of the preamble to the proposed rule, we proposed revisions to the wage index for acute care hospitals and the annual update of the wage data. Specific issues addressed included the following:

    The proposed FY 2016 wage index update using wage data from cost reporting periods beginning in FY 2012.

    Calculation of the proposed occupational mix adjustment for FY 2016 based on the 2013 Occupational Mix Survey.

    Analysis and implementation of the proposed FY 2016 occupational mix adjustment to the wage index for acute care hospitals.

    Application of the rural floor, the proposed imputed rural floor, and the frontier State floor.

    Transitional wage indexes relating to the continued use of the revised OMB labor market area delineations based on 2010 Decennial Census data.

    Proposed revisions to the wage index for acute care hospitals based on hospital redesignations and reclassifications.

    The proposed out-migration adjustment to the wage index for acute care hospitals for FY 2016 based on commuting patterns of hospital employees who reside in a county and work in a different area with a higher wage index. Beginning in FY 2016, we proposed new out-

    migration adjustments based on commuting patterns obtained from 2010 Decennial Census data.

    The timetable for reviewing and verifying the wage data used to compute the proposed FY 2016 hospital wage index.

    Determination of the labor-related share for the proposed FY 2016 wage index.

    Proposed changes to the 3-year average pension policy and proposed changes to the wage index timetable regarding pension cost for FY 2017 and subsequent years.

    Clarification of the allocation of pension costs for the wage index.

    3. Other Decisions and Proposed Changes to the IPPS for Operating Costs and Indirect Medical Education (IME) Costs

    In section IV. of the preamble of the proposed rule, we discussed proposed changes or clarifications of a number of the provisions of the regulations in 42 CFR parts 412 and 413, including the following:

    Proposed changes to the inpatient hospital updates for FY 2016, including the adjustment for hospitals that are not meaningful EHR users under section 1886(b)(3)(B)(ix) of the Act.

    The proposed updated national and regional case-mix values and discharges for purposes of determining RRC status.

    The statutorily required IME adjustment factor for FY 2016.

    Proposal for determining Medicare DSH payments and the additional payments for uncompensated care for FY 2016.

    Proposed changes to the measures and payment adjustments under the Hospital Readmissions Reduction Program.

    Proposed changes to the requirements and provision of value-based incentive payments under the Hospital Value-Based Purchasing Program.

    Proposed requirements for payment adjustments to hospitals under the HAC Reduction Program for FY 2016.

    Proposed elimination of the election by hospitals to use the simplified cost allocation methodology for Medicare cost reports.

    Discussion of the Rural Community Hospital Demonstration Program and a proposal for making a budget neutrality adjustment for the demonstration program.

    Proposed changes in postacute care transfer policies as a result of proposed new MS-DRGs.

    A statement of our intent to discuss issues related to short inpatient hospital stays, long outpatient stays with observation services, and the related -0.2 percent IPPS payment adjustment in the CY 2016 hospital outpatient prospective payment system proposed rule.

    4. Proposed FY 2016 Policy Governing the IPPS for Capital-Related Costs

    In section V. of the preamble to the proposed rule, we discussed the proposed payment policy requirements for capital-related costs and capital payments to hospitals for FY 2016.

    5. Proposed Changes to the Payment Rates for Certain Excluded Hospitals: Rate-of-Increase Percentages

    In section VI. of the preamble of the proposed rule, we discussed proposed changes to payments to certain excluded hospitals for FY 2016.

    6. Proposed Changes to the LTCH PPS

    In section VII. of the preamble of the proposed rule, we set forth--

    Proposed changes to the LTCH PPS Federal payment rates, factors, and other payment rate policies under the LTCH PPS for FY 2016.

    Proposals to implement section 1206(a)(1) of the Pathway for SGR Reform Act, which established the site neutral payment rate as the default means of paying for discharges in LTCH cost reporting periods beginning on or after October 1, 2015.

    Provisions to make technical clarifications regarding the moratoria on the establishment of new LTCHs and LTCH satellite facilities and on bed increases in existing LTCHs and LTCH satellite facilities that were established by section 1206(b)(2) of the Pathway for SGR Reform, as amended, as well as a

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    proposal to make a technical revision to the regulations to more clearly reflect our established policies.

    Proposal to revise the average length of stay criterion for LTCHs to implement section 1206(a)(3) of the Pathway for SGR Reform Act.

    7. Proposed Changes Relating to Quality Data Reporting for Specific Providers and Suppliers

    In section VIII. of the preamble of the proposed rule, we addressed--

    Proposed requirements for the Hospital Inpatient Quality Reporting (IQR) Program as a condition for receiving the full applicable percentage increase.

    Proposed changes to the requirements for the quality reporting program for PPS-exempt cancer hospitals (PCHQR Program).

    Proposed changes to the requirements under the LTCH Quality Reporting Program (LTCH QRP).

    Proposed changes to align the reporting and submission timelines for the electronic submission of clinical quality measures for the Medicare Electronic Health Record (EHR) Incentive Program for eligible hospitals and CAHs with the reporting and submission of timelines for the Hospital IQR Program. (We note that the proposal included in the proposed rule to establish in regulations an EHR technology certification criterion for reporting clinical quality measures is not being finalized in this final rule but will be addressed in a future rulemaking.)

    8. Determining Prospective Payment Operating and Capital Rates and Rate-of-Increase Limits for Acute Care Hospitals

    In the Addendum to the proposed rule, we set forth proposed changes to the amounts and factors for determining the proposed FY 2016 prospective payment rates for operating costs and capital-related costs for acute care hospitals. We also proposed to establish the threshold amounts for outlier cases. In addition, we addressed the update factors for determining the rate-of-increase limits for cost reporting periods beginning in FY 2016 for certain hospitals excluded from the IPPS.

    9. Determining Standard Federal Payment Rates for LTCHs

    In the Addendum to the proposed rule, we set forth proposed changes to the amounts and factors for determining the proposed FY 2016 LTCH PPS standard Federal payment rate. We proposed to establish the adjustments for wage levels, the labor-related share, the cost-of-

    living adjustment, and high-cost outliers, including the fixed-loss amount, and the LTCH cost-to-charge ratios (CCRs) under the LTCH PPS.

    10. Impact Analysis

    In Appendix A of the proposed rule, we set forth an analysis of the impact that the proposed changes would have on affected acute care hospitals, LTCHs, and PCHs.

    11. Recommendation of Update Factors for Operating Cost Rates of Payment for Hospital Inpatient Services

    In Appendix B of the proposed rule, as required by sections 1886(e)(4) and (e)(5) of the Act, we provided our recommendations of the appropriate percentage changes for FY 2016 for the following:

    A single average standardized amount for all areas for hospital inpatient services paid under the IPPS for operating costs of acute care hospitals (and hospital-specific rates applicable to SCHs).

    Target rate-of-increase limits to the allowable operating costs of hospital inpatient services furnished by certain hospitals excluded from the IPPS.

    The standard Federal payment rate for hospital inpatient services furnished by LTCHs.

    12. Discussion of Medicare Payment Advisory Commission Recommendations

    Under section 1805(b) of the Act, MedPAC is required to submit a report to Congress, no later than March 15 of each year, in which MedPAC reviews and makes recommendations on Medicare payment policies. MedPAC's March 2015 recommendations concerning hospital inpatient payment policies address the update factor for hospital inpatient operating costs and capital-related costs for hospitals under the IPPS. We addressed these recommendations in Appendix B of the proposed rule. For further information relating specifically to the MedPAC March 2015 report or to obtain a copy of the report, contact MedPAC at (202) 220-

    3700 or visit MedPAC's Web site at: http://www.medpac.gov.

    E. Public Comments Received in Response to the FY 2016 IPPS/LTCH PPS Proposed Rule

    We received approximately 361 timely pieces of correspondence containing multiple comments on the FY 2016 IPPS/LTCH PPS proposed rule. We note that some of these public comments were outside of the scope of the proposed rule. These out-of-scope public comments are mentioned but not addressed with the policy responses in this final rule. Summaries of the public comments that are within the scope of the proposed rule and our responses to those public comments are set forth in the various sections of this final rule under the appropriate heading.

    II. Changes to Medicare Severity Diagnosis-Related Group (MS-DRG) Classifications and Relative Weights

    A. Background

    Section 1886(d) of the Act specifies that the Secretary shall establish a classification system (referred to as diagnosis-related groups (DRGs)) for inpatient discharges and adjust payments under the IPPS based on appropriate weighting factors assigned to each DRG. Therefore, under the IPPS, Medicare pays for inpatient hospital services on a rate per discharge basis that varies according to the DRG to which a beneficiary's stay is assigned. The formula used to calculate payment for a specific case multiplies an individual hospital's payment rate per case by the weight of the DRG to which the case is assigned. Each DRG weight represents the average resources required to care for cases in that particular DRG, relative to the average resources used to treat cases in all DRGs.

    Congress recognized that it would be necessary to recalculate the DRG relative weights periodically to account for changes in resource consumption. Accordingly, section 1886(d)(4)(C) of the Act requires that the Secretary adjust the DRG classifications and relative weights at least annually. These adjustments are made to reflect changes in treatment patterns, technology, and any other factors that may change the relative use of hospital resources.

    B. MS-DRG Reclassifications

    For general information about the MS-DRG system, including yearly reviews and changes to the MS-DRGs, we refer readers to the previous discussions in the FY 2010 IPPS/RY 2010 LTCH PPS final rule (74 FR 43764 through 43766), the FY 2011 IPPS/LTCH PPS final rule (75 FR 50053 through 50055), the FY 2012 IPPS/LTCH PPS final rule (76 FR 51485 through 51487), the FY 2013 IPPS/LTCH PPS final rule (77 FR 53273), the FY 2014 IPPS/LTCH PPS final rule (78 FR 50512), and the FY 2015 IPPS/

    LTCH PPS final rule (79 FR 49871).

    C. Adoption of the MS-DRGs in FY 2008

    For information on the adoption of the MS-DRGs in FY 2008, we refer readers to the FY 2008 IPPS final rule

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    with comment period (72 FR 47140 through 47189).

    D. FY 2016 MS-DRG Documentation and Coding Adjustment

    1. Background on the Prospective MS-DRG Documentation and Coding Adjustments for FY 2008 and FY 2009 Authorized by Public Law 110-90

    In the FY 2008 IPPS final rule with comment period (72 FR 47140 through 47189), we adopted the MS-DRG patient classification system for the IPPS, effective October 1, 2007, to better recognize severity of illness in Medicare payment rates for acute care hospitals. The adoption of the MS-DRG system resulted in the expansion of the number of DRGs from 538 in FY 2007 to 745 in FY 2008. By increasing the number of MS-DRGs and more fully taking into account patient severity of illness in Medicare payment rates for acute care hospitals, MS-DRGs encourage hospitals to improve their documentation and coding of patient diagnoses.

    In the FY 2008 IPPS final rule with comment period (72 FR 47175 through 47186), we indicated that the adoption of the MS-DRGs had the potential to lead to increases in aggregate payments without a corresponding increase in actual patient severity of illness due to the incentives for additional documentation and coding. In that final rule with comment period, we exercised our authority under section 1886(d)(3)(A)(vi) of the Act, which authorizes us to maintain budget neutrality by adjusting the national standardized amount, to eliminate the estimated effect of changes in coding or classification that do not reflect real changes in case-mix. Our actuaries estimated that maintaining budget neutrality required an adjustment of -4.8 percent to the national standardized amount. We provided for phasing in this -4.8 percent adjustment over 3 years. Specifically, we established prospective documentation and coding adjustments of -1.2 percent for FY 2008, -1.8 percent for FY 2009, and -1.8 percent for FY 2010.

    On September 29, 2007, Congress enacted the TMA Transitional Medical Assistance, Abstinence Education, and QI Qualifying Individuals Programs Extension Act of 2007 (Pub. L. 110-90). Section 7(a) of Public Law 110-90 reduced the documentation and coding adjustment made as a result of the MS-DRG system that we adopted in the FY 2008 IPPS final rule with comment period to -0.6 percent for FY 2008 and -0.9 percent for FY 2009, and we finalized the FY 2008 adjustment through rulemaking, effective October 1, 2007 (72 FR 66886).

    For FY 2009, section 7(a) of Public Law 110-90 required a documentation and coding adjustment of -0.9 percent, and we finalized that adjustment through rulemaking effective October 1, 2008 (73 FR 48447). The documentation and coding adjustments established in the FY 2008 IPPS final rule with comment period, which reflected the amendments made by section 7(a) of Public Law 110-90, are cumulative. As a result, the -0.9 percent documentation and coding adjustment for FY 2009 was in addition to the -0.6 percent adjustment for FY 2008, yielding a combined effect of -1.5 percent.

    2. Adjustment to the Average Standardized Amounts Required by Public Law 110-90

  185. Prospective Adjustment Required by Section 7(b)(1)(A) of Public Law 110-90

    Section 7(b)(1)(A) of Public Law 110-90 requires that, if the Secretary determines that implementation of the MS-DRG system resulted in changes in documentation and coding that did not reflect real changes in case-mix for discharges occurring during FY 2008 or FY 2009 that are different than the prospective documentation and coding adjustments applied under section 7(a) of Public Law 110-90, the Secretary shall make an appropriate adjustment under section 1886(d)(3)(A)(vi) of the Act. Section 1886(d)(3)(A)(vi) of the Act authorizes adjustments to the average standardized amounts for subsequent fiscal years in order to eliminate the effect of such coding or classification changes. These adjustments are intended to ensure that future annual aggregate IPPS payments are the same as the payments that otherwise would have been made had the prospective adjustments for documentation and coding applied in FY 2008 and FY 2009 reflected the change that occurred in those years.

  186. Recoupment or Repayment Adjustments in FYs 2010 Through 2012 Required by Section 7(b)(1)(B) Public Law 110-90

    If, based on a retroactive evaluation of claims data, the Secretary determines that implementation of the MS-DRG system resulted in changes in documentation and coding that did not reflect real changes in case-

    mix for discharges occurring during FY 2008 or FY 2009 that are different from the prospective documentation and coding adjustments applied under section 7(a) of Public Law 110-90, section 7(b)(1)(B) of Public Law 110-90 requires the Secretary to make an additional adjustment to the standardized amounts under section 1886(d) of the Act. This adjustment must offset the estimated increase or decrease in aggregate payments for FYs 2008 and 2009 (including interest) resulting from the difference between the estimated actual documentation and coding effect and the documentation and coding adjustment applied under section 7(a) of Public Law 110-90. This adjustment is in addition to making an appropriate adjustment to the standardized amounts under section 1886(d)(3)(A)(vi) of the Act as required by section 7(b)(1)(A) of Public Law 110-90. That is, these adjustments are intended to recoup (or repay, in the case of underpayments) spending in excess of (or less than) spending that would have occurred had the prospective adjustments for changes in documentation and coding applied in FY 2008 and FY 2009 matched the changes that occurred in those years. Public Law 110-90 requires that the Secretary only make these recoupment or repayment adjustments for discharges occurring during FYs 2010, 2011, and 2012.

    3. Retrospective Evaluation of FY 2008 and FY 2009 Claims Data

    In order to implement the requirements of section 7 of Public Law 110-90, we performed a retrospective evaluation of the FY 2008 data for claims paid through December 2008 using the methodology first described in the FY 2009 IPPS/LTCH PPS final rule (73 FR 43768 and 43775) and later discussed in the FY 2010 IPPS/RY 2010 LTCH PPS final rule (74 FR 43768 through 43772). We performed the same analysis for FY 2009 claims data using the same methodology as we did for FY 2008 claims (75 FR 50057 through 50068). The results of the analysis for the FY 2011 IPPS/

    LTCH PPS proposed and final rules, and subsequent evaluations in FY 2012, supported that the 5.4 percent estimate accurately reflected the FY 2009 increases in documentation and coding under the MS-DRG system. We were persuaded by both MedPAC's analysis (as discussed in the FY 2011 IPPS/LTCH PPS final rule (75 FR 50064 through 50065)) and our own review of the methodologies recommended by various commenters that the methodology we employed to determine the required documentation and coding adjustments was sound.

    As in prior years, the FY 2008, FY 2009, and FY 2010 MedPAR files are available to the public to allow independent analysis of the FY 2008 and FY 2009 documentation and coding

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    effects. Interested individuals may still order these files through the CMS Web site at: http://www.cms.gov/Research-Statistics-Data-and-Systems/Files-for-Order/LimitedDataSets/ by clicking on MedPAR Limited Data Set (LDS)-Hospital (National). This CMS Web page describes the file and provides directions and further detailed instructions for how to order.

    Persons placing an order must send the following: a Letter of Request, the LDS Data Use Agreement and Research Protocol (refer to the Web site for further instructions), the LDS Form, and a check (refer to the Web site for the required payment amount) to:

    Mailing address if using the U.S. Postal Service: Centers for Medicare & Medicaid Services, RDDC Account, Accounting Division, P.O. Box 7520, Baltimore, MD 21207-0520.

    Mailing address if using express mail: Centers for Medicare & Medicaid Services, OFM/Division of Accounting--RDDC, 7500 Security Boulevard, C3-07-11, Baltimore, MD 21244-1850.

    4. Prospective Adjustments for FY 2008 and FY 2009 Authorized by Section 7(b)(1)(A) of Public Law 110-90

    In the FY 2010 IPPS/RY 2010 LTCH PPS final rule (74 FR 43767 through 43777), we opted to delay the implementation of any documentation and coding adjustment until a full analysis of case-mix changes based on FY 2009 claims data could be completed. We refer readers to the FY 2010 IPPS/RY LTCH PPS final rule for a detailed description of our proposal, responses to comments, and finalized policy. After analysis of the FY 2009 claims data for the FY 2011 IPPS/

    LTCH PPS final rule (75 FR 50057 through 50073), we found a total prospective documentation and coding effect of 5.4 percent. After accounting for the -0.6 percent and the -0.9 percent documentation and coding adjustments in FYs 2008 and 2009, we found a remaining documentation and coding effect of 3.9 percent. As we have discussed, an additional cumulative adjustment of -3.9 percent would be necessary to meet the requirements of section 7(b)(1)(A) of Public Law 110-90 to make an adjustment to the average standardized amounts in order to eliminate the full effect of the documentation and coding changes that do not reflect real changes in case-mix on future payments. Unlike section 7(b)(1)(B) of Public Law 110-90, section 7(b)(1)(A) does not specify when we must apply the prospective adjustment, but merely requires us to make an ``appropriate'' adjustment. Therefore, as we stated in the FY 2011 IPPS/LTCH PPS final rule (75 FR 50061), we believed the law provided some discretion as to the manner in which we applied the prospective adjustment of -3.9 percent. As we discussed extensively in the FY 2011 IPPS/LTCH PPS final rule, it has been our practice to moderate payment adjustments when necessary to mitigate the effects of significant downward adjustments on hospitals, to avoid what could be widespread, disruptive effects of such adjustments on hospitals. Therefore, we stated that we believed it was appropriate to not implement the -3.9 percent prospective adjustment in FY 2011 because we finalized a -2.9 percent recoupment adjustment for that fiscal year. Accordingly, we did not propose a prospective adjustment under section 7(b)(1)(A) of Public Law 110-90 for FY 2011 (75 FR 23868 through 23870). We noted that, as a result, payments in FY 2011 (and in each future fiscal year until we implemented the requisite adjustment) would be higher than they would have been if we had implemented an adjustment under section 7(b)(1)(A) of Public Law 110-90.

    In the FY 2012 IPPS/LTCH PPS final rule (76 FR 51489 and 51497), we indicated that, because further delay of this prospective adjustment would result in a continued accrual of unrecoverable overpayments, it was imperative that we implement a prospective adjustment for FY 2012, while recognizing CMS' continued desire to mitigate the effects of any significant downward adjustments to hospitals. Therefore, we implemented a -2.0 percent prospective adjustment to the standardized amount instead of the full -3.9 percent.

    In the FY 2013 IPPS/LTCH PPS final rule (77 FR 53274 through 53276), we completed the prospective portion of the adjustment required under section 7(b)(1)(A) of Public Law 110-90 by finalizing a -1.9 percent adjustment to the standardized amount for FY 2013. We stated that this adjustment would remove the remaining effect of the documentation and coding changes that do not reflect real changes in case-mix that occurred in FY 2008 and FY 2009. We believed that it was imperative to implement the full remaining adjustment, as any further delay would result in an overstated standardized amount in FY 2013 and any future fiscal years until a full adjustment was made.

    We noted again that delaying full implementation of the prospective portion of the adjustment required under section 7(b)(1)(A) of Public Law 110-90 until FY 2013 resulted in payments in FY 2010 through FY 2012 being overstated. These overpayments could not be recovered by CMS because section 7(b)(1)(B) of Public Law 110-90 limited recoupments to overpayments made in FY 2008 and FY 2009.

    5. Recoupment or Repayment Adjustment Authorized by Section 7(b)(1)(B) of Public Law 110-90

    Section 7(b)(1)(B) of Public Law 110-90 requires the Secretary to make an adjustment to the standardized amounts under section 1886(d) of the Act to offset the estimated increase or decrease in aggregate payments for FY 2008 and FY 2009 (including interest) resulting from the difference between the estimated actual documentation and coding effect and the documentation and coding adjustments applied under section 7(a) of Public Law 110-90. This determination must be based on a retrospective evaluation of claims data. Our actuaries estimated that there was a 5.8 percentage point difference resulting in an increase in aggregate payments of approximately $6.9 billion. Therefore, as discussed in the FY 2011 IPPS/LTCH PPS final rule (75 FR 50062 through 50067), we determined that an aggregate adjustment of -5.8 percent in FYs 2011 and 2012 would be necessary in order to meet the requirements of section 7(b)(1)(B) of Public Law 110-90 to adjust the standardized amounts for discharges occurring in FYs 2010, 2011, and/or 2012 to offset the estimated amount of the increase in aggregate payments (including interest) in FYs 2008 and 2009.

    It is often our practice to phase in payment rate adjustments over more than one year in order to moderate the effect on payment rates in any one year. Therefore, consistent with the policies that we have adopted in many similar cases, in the FY 2011 IPPS/LTCH PPS final rule, we made an adjustment to the standardized amount of -2.9 percent, representing approximately one-half of the aggregate adjustment required under section 7(b)(1)(B) of Public Law 110-90, for FY 2011. An adjustment of this magnitude allowed us to moderate the effects on hospitals in one year while simultaneously making it possible to implement the entire adjustment within the timeframe required under section 7(b)(1)(B) of Public Law 110-90 (that is, no later than FY 2012). For FY 2012, in accordance with the timeframes set forth by section 7(b)(1)(B) of Public Law 110-90, and consistent with the discussion in the FY 2011 IPPS/LTCH PPS final rule, we completed the recoupment adjustment by implementing the remaining -2.9 percent adjustment, in addition to removing the effect of the -2.9 percent

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    adjustment to the standardized amount finalized for FY 2011 (76 FR 51489 and 51498). Because these adjustments, in effect, balanced out, there was no year-to-year change in the standardized amount due to this recoupment adjustment for FY 2012. In the FY 2013 IPPS/LTCH PPS final rule (77 FR 53276), we made a final +2.9 percent adjustment to the standardized amount, completing the recoupment portion of section 7(b)(1)(B) of Public Law 110-90. We note that with this positive adjustment, according to our estimates, all overpayments made in FY 2008 and FY 2009 have been fully recaptured with appropriate interest, and the standardized amount has been returned to the appropriate baseline.

    6. Recoupment or Repayment Adjustment Authorized by Section 631 of the American Taxpayer Relief Act of 2012 (ATRA)

    Section 631 of the ATRA amended section 7(b)(1)(B) of Public Law 110-90 to require the Secretary to make a recoupment adjustment or adjustments totaling $11 billion by FY 2017. This adjustment represents the amount of the increase in aggregate payments as a result of not completing the prospective adjustment authorized under section 7(b)(1)(A) of Public Law 110-90 until FY 2013. As discussed earlier, this delay in implementation resulted in overstated payment rates in FYs 2010, 2011, and 2012. The resulting overpayments could not have been recovered under Public Law 110-90.

    Similar to the adjustments authorized under section 7(b)(1)(B) of Public Law 110-90, the adjustment required under section 631 of the ATRA is a one-time recoupment of a prior overpayment, not a permanent reduction to payment rates. Therefore, we anticipated that any adjustment made to reduce payment rates in one year would eventually be offset by a single positive adjustment in FY 2018, once the necessary amount of overpayment was recovered. However, we note that section 414 of the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015, Public Law 114-10, enacted on April 16, 2015, replaced the single positive adjustment we intended to make in FY 2018 with a 0.5 percent positive adjustment for each of FYs 2018 through 2023. The provision under section 414 of the MACRA does not impact our FY 2016 adjustment, and we will address this MACRA provision in future rulemaking.

    As we stated in the FY 2014 IPPS/LTCH PPS final rule (78 FR 50515 through 50517), our actuaries estimate that a -9.3 percent adjustment to the standardized amount would be necessary if CMS were to fully recover the $11 billion recoupment required by section 631 of the ATRA in FY 2014. It is often our practice to phase in payment rate adjustments over more than one year, in order to moderate the effect on payment rates in any one year. Therefore, consistent with the policies that we have adopted in many similar cases, and after consideration of the public comments we received, in the FY 2014 IPPS/LTCH PPS final rule (78 FR 50515 through 50517), we implemented a -0.8 percent recoupment adjustment to the standardized amount in FY 2014. We stated that if adjustments of approximately -0.8 percent are implemented in FYs 2014, 2015, 2016, and 2017, using standard inflation factors, we estimate that the entire $11 billion will be accounted for by the end of the statutory 4-year timeline. As estimates of any future adjustments are subject to slight variations in total savings, we did not provide for specific adjustments for FYs 2015, 2016, or 2017 at that time. We stated that we believed that this level of adjustment for FY 2014 was a reasonable and fair approach that satisfies the requirements of the statute while mitigating extreme annual fluctuations in payment rates.

    Consistent with the approach discussed in the FY 2014 IPPS/LTCH PPS final rule for recouping the $11 billion required by section 631 of the ATRA, in the FY 2015 IPPS/LTCH PPS final rule (79 FR 49873 through 49874), we implemented an additional -0.8 percent recoupment adjustment to the standardized amount for FY 2015. We estimated that this level of adjustment, combined with leaving the -0.8 percent adjustment made for FY 2014 in place, would recover up to $2 billion in FY 2015. When combined with the approximately $1 billion adjustment made in FY 2014, we estimated that approximately $8 billion would be left to recover under section 631 of the ATRA.

    Consistent with the approach discussed in the FY 2014 IPPS/LTCH PPS final rule for recouping the $11 billion required by section 631 of the ATRA, we proposed in the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24342) to implement a -0.8 percent recoupment adjustment to the standardized amount for FY 2016. We estimated that this level of adjustment, combined with leaving the -0.8 percent adjustments made for FY 2014 and FY 2015 in place, would recover up to $3 billion in FY 2016.

    Comment: Several commenters restated their previous position, as set forth in comments submitted in response to the FY 2014 and FY 2015 IPPS/LTCH PPS proposed rules and summarized in the FY 2014 IPPS/LTCH PPS final rule, that CMS overstated the impact of documentation and coding effects for prior years. The commenters cited potential deficiencies in the CMS methodology and disagreed that the congressionally mandated adjustment is warranted. However, the majority of these commenters conceded that CMS is required by section 631 of the ATRA to recover $11 billion by FY 2017, and supported CMS' policy to phase in the adjustments over a 4-year period.

    Response: We refer readers to the FY 2014 IPPS/LTCH PPS final rule (78 FR 50515 through 50517) for our response to the commenters' position that CMS overstated the impact of documentation and coding effects. We appreciate the commenters' acknowledgement that we are required by section 631 of the ATRA to recover $11 billion by FY 2017.

    After consideration of the public comments we received, we are finalizing the proposal to make an additional -0.8 percent recoupment adjustment to the standardized amount for FY 2016. Taking into account the cumulative effects of this adjustment and the adjustments made in FYs 2014 and 2015, we currently estimate that approximately $5 to $6 billion would be left to recover under section 631 of the ATRA by the end of FY 2016. As we explained in the FY 2014 and FY 2015 IPPS/LTCH PPS final rules, estimates of any future adjustments are subject to variations in total estimated savings. Therefore, we have not yet addressed the specific amount of the final adjustment required under section 631 of the ATRA for FY 2017. We intend to address this adjustment in the FY 2017 IPPS rulemaking. As stated earlier, we also note that section 414 of the MACRA (Pub. L. 114-10), enacted on April 16, 2015, replaced the single positive adjustment we intended to make in FY 2018 with a 0.5 percent positive adjustment for each of FYs 2018 through 2023. The provision under section 414 of the MACRA does not impact our FY 2016 recoupment adjustment, and we will address this MACRA provision in future rulemaking.

    E. Refinement of the MS-DRG Relative Weight Calculation

    1. Background

    Beginning in FY 2007, we implemented relative weights for DRGs based on cost report data instead of charge information. We refer readers to the FY 2007 IPPS final rule (71 FR 47882) for a detailed discussion of our final policy for calculating the cost-based DRG relative weights and to the

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    FY 2008 IPPS final rule with comment period (72 FR 47199) for information on how we blended relative weights based on the CMS DRGs and MS-DRGs.

    As we implemented cost-based relative weights, some public commenters raised concerns about potential bias in the weights due to ``charge compression,'' which is the practice of applying a higher percentage charge markup over costs to lower cost items and services, and a lower percentage charge markup over costs to higher cost items and services. As a result, the cost-based weights would undervalue high-cost items and overvalue low-cost items if a single cost-to-charge ratio (CCR) is applied to items of widely varying costs in the same cost center. To address this concern, in August 2006, we awarded a contract to the Research Triangle Institute, International (RTI) to study the effects of charge compression in calculating the relative weights and to consider methods to reduce the variation in the CCRs across services within cost centers. For a detailed summary of RTI's findings, recommendations, and public comments that we received on the report, we refer readers to the FY 2009 IPPS/LTCH PPS final rule (73 FR 48452 through 48453). In addition, we refer readers to RTI's July 2008 final report titled ``Refining Cost to Charge Ratios for Calculating APC and MS-DRG Relative Payment Weights'' (http://www.rti.org/reports/cms/HHSM-500-2005-0029I/PDF/Refining_Cost_to_Charge_Ratios_200807_Final.pdf).

    In the FY 2009 IPPS final rule (73 FR 48458 through 48467), in response to the RTI's recommendations concerning cost report refinements, we discussed our decision to pursue changes to the cost report to split the cost center for Medical Supplies Charged to Patients into one line for ``Medical Supplies Charged to Patients'' and another line for ``Implantable Devices Charged to Patients.'' We acknowledged, as RTI had found, that charge compression occurs in several cost centers that exist on the Medicare cost report. However, as we stated in the FY 2009 IPPS final rule, we focused on the CCR for Medical Supplies and Equipment because RTI found that the largest impact on the MS-DRG relative weights could result from correcting charge compression for devices and implants. In determining the items that should be reported in these respective cost centers, we adopted the commenters' recommendations that hospitals should use revenue codes established by the AHA's National Uniform Billing Committee to determine the items that should be reported in the ``Medical Supplies Charged to Patients'' and the ``Implantable Devices Charged to Patients'' cost centers. Accordingly, a new subscripted line for ``Implantable Devices Charged to Patients'' was created in July 2009. This new subscripted cost center has been available for use for cost reporting periods beginning on or after May 1, 2009.

    As we discussed in the FY 2009 IPPS final rule (73 FR 48458) and in the CY 2009 OPPS/ASC final rule with comment period (73 FR 68519 through 68527), in addition to the findings regarding implantable devices, RTI also found that the costs and charges of computed tomography (CT) scans, magnetic resonance imaging (MRI), and cardiac catheterization differ significantly from the costs and charges of other services included in the standard associated cost center. RTI also concluded that both the IPPS and the OPPS relative weights would better estimate the costs of those services if CMS were to add standard cost centers for CT scans, MRIs, and cardiac catheterization in order for hospitals to report separately the costs and charges for those services and in order for CMS to calculate unique CCRs to estimate the costs from charges on claims data. In the FY 2011 IPPS/LTCH PPS final rule (75 FR 50075 through 50080), we finalized our proposal to create standard cost centers for CT scans, MRIs, and cardiac catheterization, and to require that hospitals report the costs and charges for these services under new cost centers on the revised Medicare cost report Form CMS-2552-10. (We refer readers to the FY 2011 IPPS/LTCH PPS final rule (75 FR 50075 through 50080) for a detailed discussion of the reasons for the creation of standard cost centers for CT scans, MRIs, and cardiac catheterization.) The new standard cost centers for CT scans, MRIs, and cardiac catheterization are effective for cost reporting periods beginning on or after May 1, 2010, on the revised cost report Form CMS-2552-10.

    In the FY 2009 IPPS final rule (73 FR 48468), we stated that, due to what is typically a 3-year lag between the reporting of cost report data and the availability for use in ratesetting, we anticipated that we might be able to use data from the new ``Implantable Devices Charged to Patients'' cost center to develop a CCR for ``Implantable Devices Charged to Patients'' in the FY 2012 or FY 2013 IPPS rulemaking cycle. However, as noted in the FY 2010 IPPS/RY 2010 LTCH PPS final rule (74 FR 43782), due to delays in the issuance of the revised cost report Form CMS 2552-10, we determined that a new CCR for ``Implantable Devices Charged to Patients'' might not be available before FY 2013. Similarly, when we finalized the decision in the FY 2011 IPPS/LTCH PPS final rule to add new cost centers for CT scans, MRIs, and cardiac catheterization, we explained that data from any new cost centers that may be created will not be available until at least 3 years after they are first used (75 FR 50077). In preparation for the FY 2012 IPPS/LTCH PPS rulemaking, we checked the availability of data in the ``Implantable Devices Charged to Patients'' cost center on the FY 2009 cost reports, but we did not believe that there was a sufficient amount of data from which to generate a meaningful analysis in this particular situation. Therefore, we did not propose to use data from the ``Implantable Devices Charged to Patients'' cost center to create a distinct CCR for ``Implantable Devices Charged to Patients'' for use in calculating the MS-DRG relative weights for FY 2012. We indicated that we would reassess the availability of data for the ``Implantable Devices Charged to Patients'' cost center for the FY 2013 IPPS/LTCH PPS rulemaking cycle and, if appropriate, we would propose to create a distinct CCR at that time.

    During the development of the FY 2013 IPPS/LTCH PPS proposed and final rules, hospitals were still in the process of transitioning from the previous cost report Form CMS-2552-96 to the new cost report Form CMS-2552-10. Therefore, we were able to access only those cost reports in the FY 2010 HCRIS with fiscal year begin dates on or after October 1, 2009, and before May 1, 2010; that is, those cost reports on Form CMS-2552-96. Data from the Form CMS-2552-10 cost reports were not available because cost reports filed on the Form CMS-2552-10 were not accessible in the HCRIS. Further complicating matters was that, due to additional unforeseen technical difficulties, the corresponding information regarding charges for implantable devices on hospital claims was not yet available to us in the MedPAR file. Without the breakout in the MedPAR file of charges associated with implantable devices to correspond to the costs of implantable devices on the cost report, we believed that we had no choice but to continue computing the relative weights with the current CCR that combines the costs and charges for supplies and implantable devices. We stated in the FY 2013 IPPS/LTCH PPS final rule (77 FR 53281 through 53283) that when we do have the necessary data for supplies and implantable

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    devices on the claims in the MedPAR file to create distinct CCRs for the respective cost centers for supplies and implantable devices, we hoped that we would also have data for an analysis of creating distinct CCRs for CT scans, MRIs, and cardiac catheterization, which could then be finalized through rulemaking. In the FY 2013 IPPS/LTCH PPS final rule (77 FR 53281), we stated that, prior to proposing to create these CCRs, we would first thoroughly analyze and determine the impacts of the data, and that distinct CCRs for these new cost centers would be used in the calculation of the relative weights only if they were first finalized through rulemaking.

    At the time of the development of the FY 2014 IPPS/LTCH PPS proposed rule (78 FR 27506 through 27507), we had a substantial number of hospitals completing all, or some, of these new cost centers on the FY 2011 Medicare cost reports, compared to prior years. We stated that we believed that the analytic findings described using the FY 2011 cost report data and FY 2012 claims data supported our original decision to break out and create new cost centers for implantable devices, MRIs, CT scans, and cardiac catheterization, and we saw no reason to further delay proposing to implement the CCRs of each of these cost centers. Therefore, beginning in FY 2014, we proposed a policy to calculate the MS-DRG relative weights using 19 CCRs, creating distinct CCRs from cost report data for implantable devices, MRIs, CT scans, and cardiac catheterization.

    We refer readers to the FY 2014 IPPS/LTCH PPS proposed rule (78 FR 27507 through 27509) and final rule (78 FR 50518 through 50523) in which we presented data analyses using distinct CCRs for implantable devices, MRIs, CT scans, and cardiac catheterization. The FY 2014 IPPS/

    LTCH PPS final rule also set forth our responses to public comments we received on our proposal to implement these CCRs. As explained in more detail in the FY 2014 IPPS/LTCH PPS final rule, we finalized our proposal to use 19 CCRs to calculate MS-DRG relative weights beginning in FY 2014--the then existing 15 cost centers and the 4 new CCRs for implantable devices, MRIs, CT scans, and cardiac catheterization. Therefore, beginning in FY 2014, we calculate the IPPS MS-DRG relative weights using 19 CCRs, creating distinct CCRs for implantable devices, MRIs, CT scans, and cardiac catheterization.

    2. Discussion for FY 2016 and Summary of Public Comments Received in Response to Request on Nonstandard Cost Center Codes

    Consistent with the policy established beginning for FY 2014, we calculated the MS-DRG relative weights for FY 2016 using two data sources: The MedPAR file as the claims data source and the HCRIS as the cost report data source. We adjusted the charges from the claims to costs by applying the 19 national average CCRs developed from the cost reports. The description of the calculation of the 19 CCRs and the MS-

    DRG relative weights for FY 2016 is included in section II.H.3. of the preamble of this final rule.

    In preparing to calculate the 19 national average CCRs developed from the cost reports, we reviewed the HCRIS data and noticed inconsistencies in hospitals' cost reporting and use of nonstandard cost center codes. In addition, we discovered that hospitals typically report the nonstandard codes with standard cost centers that are different from the standard cost centers to which CMS maps and ``rolls up'' each nonstandard code in compiling the HCRIS. As stated in the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24344), we are concerned that inconsistencies in hospitals' use of nonstandard codes, coupled with differences in the way hospitals and CMS map these nonstandard codes to standard lines, may have implications for the calculation of the 19 CCRs and the aspects of the IPPS that rely on the CCRs (for example, the calculation of the MS-DRG relative weights).

    The Medicare cost report Form CMS-2552-10, Worksheet A, includes preprinted cost center codes that reflect the standard cost center descriptions by category (General Service, Routine, and Ancillary) used in most hospitals. Each preprinted standard cost center is assigned a unique 5-digit code. The preprinted 5-digit codes provide standardized meaning for data analysis, and are automatically coded by CMS-approved cost report software. To accommodate hospitals that have additional cost centers that are sufficiently different from the preprinted standard cost centers, CMS identified additional cost centers known as ``nonstandard'' cost centers. Each nonstandard cost center must be labeled appropriately and reported under a specific standard cost center. For example, under the standard cost center ``Electrocardiology'' with its 5-digit code of 06900, there are six nonstandard cost centers (for EKG and EEG, Electromyography, Cardiopulmonary, Stress Test, Cardiology, and Holter Monitor), each with a unique 5-digit code.

    The instructions for the Medicare cost report Form CMS-2552-10 explain the purpose and requirements related to the standard and nonstandard cost centers. Specifically, in CMS Pub. 15-2, Chapter 40, Section 4013, the instructions for Worksheet A of Form CMS-2552-10 state:

    ``Cost center coding is a methodology for standardizing the meaning of cost center labels as used by health care providers on the Medicare cost report. Form CMS-2552-10 provides for preprinted cost center descriptions on Worksheet A. In addition, a space is provided for a cost center code. The preprinted cost center labels are automatically coded by CMS approved cost reporting software. These cost center descriptions are hereafter referred to as the standard cost centers. Additionally, nonstandard cost center descriptions have been identified through analysis of frequently used labels.

    The use of this coding methodology allows providers to continue to use labels for cost centers that have meaning within the individual institution. The five digit cost center codes that are associated with each provider label in their electronic file provide standardized meaning for data analysis. You are required to compare any added or changed label to the descriptions offered on the standard or nonstandard cost center tables. A description of cost center coding and the table of cost center codes are in Sec. 4095, Table 5.''

    Section 4095 of CMS Pub. 15-2 (pages 40-805 and 40-806) further provides that: ``Both the standard and nonstandard cost center descriptions along with their cost center codes are shown on Table 5 . . . . Cost center codes may only be used in designated lines in accordance with the classification of the cost center(s), i.e., lines 1 through 23 may only contain cost center codes within the general service cost center category of both standard and nonstandard coding. For example, in the general service cost center category for Operation of Plant cost, line 7 and subscripts thereof should only contain cost center codes of 00700-00719 and nonstandard cost center codes. This logic must hold true for all other cost center categories, i.e., ancillary, inpatient routine, outpatient, other reimbursable, special purpose, and non- reimbursable cost centers.''

    Table 5 of Section 4095, Chapter 40, of CMS Pub. 15-2 (pages 40-807 through 40-810) lists the electronic reporting specifications for each

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    standard cost center, its 5-digit code, and, separately, the nonstandard cost center descriptions and their 5-digit codes. While the nonstandard codes are categorized by General Service Cost Centers, Inpatient Routine Service Cost Centers, and Ancillary Service Cost Centers, among others, Table 5 does not map the nonstandard cost centers and codes to specific standard cost centers. In addition, the CMS-approved cost reporting software does not restrict the use of nonstandard codes to specific standard cost centers. Furthermore, the software does not prevent hospitals from manually entering in a name for a nonstandard cost center code that may be different from the name that CMS assigned to that nonstandard cost center code. For example, Table 5 specifies that the 5-digit code for the Ancillary Service nonstandard cost center ``Acupuncture'' is 03020. When CMS creates the HCRIS SAS files, CMS maps all codes 03020 to standard line 53, ``Anesthesiology''.\1\ However, a review of the December 31, 2014 update of the FY 2013 HCRIS SAS files, from which the proposed 19 CCRs for FY 2016 were calculated, revealed that, of the 3,172 times that nonstandard code 03020 was reported by hospitals, it is called ``Acupuncture'' only 122 times. Instead, hospitals use various names for nonstandard code 03020, such as ``Cardiopulmonary,'' ``Sleep Lab,'' ``Diabetes Center,'' or ``Wound Care''.

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    \1\ To view how CMS rolls up the codes to create the HCRIS SAS files, we refer readers to http://www.cms.gov/Research-Statistics-Data-and-Systems/Downloadable-Public-Use-Files/Cost-Reports/Hospital-2010-form.html. On this page, click on ``Hospital-2010-

    SAS.ZIP (SAS datasets and documentation)'', and from the zip file, choose the Excel spreadsheet ``2552-10 SAS FILE RECORD LAYOUT AND CROSSWALK TO 96.xlsx''. The second tab of this spreadsheet is ``NEW ROLLUPS'', and shows the standard and nonstandard 5-digit codes (columns B and C) that CMS rolls up to each standard line (column G).

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    As noted above, the Ancillary Service standard cost center for ``Anesthesiology'', line 53 of Worksheet A and subsequent worksheets of the Medicare cost report Form CMS-2552-10 (and its associated nonstandard cost center code 03020 ``Acupuncture'') is an example of a cost center that is subject to inconsistent reporting. Our review of the FY 2013 HCRIS as-submitted cost reports from which the proposed 19 CCRs for FY 2016 were calculated revealed that, regardless of the actual name hospitals assigned to nonstandard code 03020 (for example, ``Acupuncture'' or otherwise), hospitals reported this code almost 100 percent of the time on standard line 76, ``Other Ancillary,'' and never on standard line 53, ``Anesthesiology.'' Yet, as noted above, CMS (and previously HCFA, under earlier versions of the Medicare cost report), in creating the HCRIS database, has had the longstanding practice of mapping and rolling up all instances of nonstandard code 03020 to standard line 53, ``Anesthesiology,'' not to standard line 76, ``Other Ancillary. Therefore, the version of the HCRIS SAS files created by CMS, which CMS uses for ratesetting purposes, may differ somewhat from the as-submitted cost reports of hospitals because CMS moves various nonstandard cost centers based on cost center codes, not cost center descriptions, from the standard cost centers in which hospitals report them and places them in different standard cost centers based on CMS' roll-up specifications.

    In the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24345), we highlighted the discrepancy in the reporting of nonstandard code 03020 ``Acupuncture'' because the placement of nonstandard code 03020 and its related costs and charges seem to have the most significant implications for the calculation of one of the 19 CCRs, the Anesthesia CCR. As stated in section II.H.3. of the preamble of the proposed rule (80 FR 24413), the proposed FY 2016 CCR for Anesthesia was 0.108. We calculated this proposed CCR based on the December 31, 2014 update of the FY 2013 HCRIS, with the nonstandard cost center codes of 03020 through 03029 rolled up to standard line 53, ``Anesthesiology.'' That is, under the CMS' HCRIS specifications, we rolled up the following 5-

    digit codes to standard line 53, ``Anesthesiology'': \2\ standard codes for ``Anesthesiology'' 05300 through 05329; and nonstandard codes for ``Acupuncture'' 03020 through 03029. For simulation purposes, we also created a version of the December 31, 2014 update of the FY 2013 HCRIS which retained nonstandard codes 03020 through 03029 on standard line 76, ``Other Ancillary,'' where hospitals actually reported these codes on their as-submitted FY 2013 cost reports. When all reported uses of nonstandard codes 03020 through 03029 remain on standard line 76, ``Other Ancillary,'' we calculated that the Anesthesia CCR would be 0.084 (instead of 0.108 as proposed in section II.H.3. of the preamble of the FY 2016 IPPS/LTCH PPS proposed rule). We also looked at the effect on the other 18 CCRs. In the version of HCRIS we created for simulation purposes, by keeping the nonstandard cost center codes in standard line 76, ``Other Ancillary,'' where hospitals typically report them, rather than remapping them according to CMS specifications, three other CCRs also were affected, although not quite as significantly as the Anesthesia CCR. As proposed in section II.H.3. of the preamble of the FY 2016 IPPS/LTCH PPS proposed rule, the proposed FY 2016 Cardiology CCR was 0.119. However, when all cardiology-related nonstandard codes were rolled up to standard line 76, ``Other Ancillary'', and not to standard line 69, ``Electrocardiology'' as under CMS' usual practice, the Cardiology CCR was 0.113. In addition, as proposed in section II.H.3. of the preamble of the FY 2016 IPPS/LTCH PPS proposed rule, the proposed FY 2016 Radiology CCR was 0.159. However, when all radiology-related nonstandard codes were rolled up to standard line 76, ``Other Ancillary'', and not to standard lines 54 (Radiology-Diagnostic), 55 (Radiology-Therapeutic), and 56 (Radioisotope) as under CMS' usual practice, the Radiology CCR was 0.161. Most notably, the CCR that was most impacted was the ``Other Services'' CCR. As proposed in section II.H.3. of the preamble of the FY 2016 proposed rule, the ``Other Services'' CCR was 0.367. However, if all nonstandard cost center codes remained in line 76, ``Other Ancillary'' as hospitals have reported them in their FY 2013 as-

    submitted cost reports, instead of CMS applying its usual practice of rolling up these lines to the applicable ``Electrocardiology'' and ``Radiology'' standard cost centers, among others, the ``Other Services'' CCR was 0.291. We note that we observed minimal or no differences in the remaining 15 CCRs, when their associated nonstandard cost centers were rolled up to their specific standard cost centers, versus being rolled up to the standard line 76, ``Other Ancillary.''

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    \2\ Ibid.

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    The differences in these CCRs computed from the HCRIS that was compiled by applying CMS' current rollup procedures of assigning nonstandard codes to specific standard cost centers, as compared to following hospitals' general practice of reporting nonstandard codes ``en masse'' on line 76, ``Other Ancillary,'' have implications for the aspects of the IPPS that rely on the CCRs (for example, the calculation of the MS-DRG relative weights). In the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24345), we discussed that some questions arise: whether CMS' procedures for mapping and rolling up nonstandard cost centers to specific standard cost centers should be updated; whether hospital reporting practices are imprecise; or whether there is a combination of both of these

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    questions. CMS' rollup procedures were developed many years ago based on historical analysis of hospitals' cost reporting practices and health care services furnished. It may be that it would be appropriate for CMS to reevaluate its rollup procedures based on hospitals' more current cost reporting practices and contemporary health care services provided. However, one factor complicating the determination of the most accurate standard cost centers to which each respective nonstandard cost center should be mapped is hospitals' own inconsistent reporting practices. For example, it may be determined that CMS should no longer be mapping and rolling up nonstandard cost center ``Acupuncture'' and its associated 5-digit codes 03020 through 03029 to standard cost center line 53, ``Anesthesiology.'' However, determining which other standard line ``Acupuncture'' and its associated 5-digit codes 03020 through 03029 should be mapped to is unclear, given that, as mentioned above, out of the 3,172 times that codes 03020 through 03029 were reported in the FY 2013 HCRIS file, hospitals called these codes ``Acupuncture'' only 122 times, and instead called these codes a variety of other names (such as Cardiopulmonary, Sleep Lab, Wound Care, Diabetes Center, among others). Therefore, without being able to determine the true nature of the services that were actually provided, it is difficult to know which standard cost center to map these services. That is, the question arises as to whether the service provided was acupuncture because a hospital reported code 03020, or whether the service provided was cardiopulmonary, which was the name a hospital assigned to code 03020. Furthermore, if the service provided was in fact cardiopulmonary, then, as Table 5 of Section 4095 of CMS Pub. 15-2 indicates, the correct nonstandard code for cardiopulmonary is 03160, not 03020. A related question would be, if the hospital provided cardiopulmonary services, which are clearly related to cardiology, why did the hospital report those costs and charges on line 76, ``Other Ancillary,'' instead of subscripting standard line 69, ``Electrocardiology,'' and reporting the cardiopulmonary costs and charges there.

    In summary, we stated in the FY 2016 IPPS/LTCH PPS proposed rule that we believe that the differences between the standard cost centers to which CMS assigns nonstandard codes when CMS rolls up cost report data to create the HCRIS SAS database, and the standard cost centers to which hospitals tend to assign and use nonstandard codes, coupled with the inconsistencies found in hospitals' use and naming of the nonstandard codes, have implications for the aspects of the IPPS that rely on the CCRs. For example, we have explained above and provided examples of how the CCRs used to calculate the MS-DRG relative weights could change, based on where certain nonstandard codes are reported and rolled up in the cost reports. However, before considering changes to our longstanding practices, in the proposed rule, we solicited public comments from stakeholders as to how to improve the use of nonstandard cost center codes. We indicated that one option might be for CMS to allow only certain nonstandard codes to be used with certain standard cost centers, meaning that CMS might require that the CMS-approved cost reporting software ``lock in'' those nonstandard codes with their assigned standard cost centers. For example, if a hospital wishes to subscript a standard cost center, the cost reporting software might allow the hospital to choose only from a predetermined set of nonstandard codes. Therefore, for example, if a hospital wished to report Cardiopulmonary costs and charges on its cost report, the only place that the hospital could do that under this approach would be from a drop down list of cardiology-related services on standard line 69, ``Electrocardiology,'' and not on another line (not even line 76, ``Other Ancillary''). We stated that some flexibility could be maintained, but within certain limits, in consideration of unique services that hospitals might provide.

    Below we summarize the public comments that we received in response to our solicitation of comments on nonstandard cost center codes.

    Comment: Several commenters expressed concern that issues related to reporting of costs and charges in the nonstandard cost centers could affect the validity of the CCRs used to develop the relative weights. The commenters requested that CMS provide more cost reporting instruction so that the accuracy and validity of the CCRs could be improved, through more detailed examples of how cost report and claims data are used for ratesetting, identifying what revenue codes and services should be associated with specific cost centers, and providing detailed instructions regarding cost allocation methods. The commenters believed that these types of actions would resolve some of the inconsistencies in hospital cost reporting. Several commenters supported more specific guidance and data processing on cost reporting and supported CMS' idea to ``lock in'' certain nonstandard codes with specific cost centers in the cost reporting softwares, but wanted to retain flexibility in terms of available options.

    Commenters requested that CMS work with stakeholders through methods such as additional engagement with the provider community and convening a technical workgroup to receive stakeholder input. Several commenters requested that CMS provide sufficient advance notice when cost reporting process changes are made, noting that it would take time for hospitals to implement changes to their internal cost reporting processes. The commenters were generally supportive of efforts to improve the cost reporting process and cost estimation accuracy. One commenter stated that inconsistencies in reporting of nonstandard cost centers compound the problems the commenter raised in earlier public comments regarding allocation of capital costs and the new CCRs for MRIs and CT scans. Other commenters stated generally that the use of distinct CCRs for MRI and CT scans produces ``payment rates that lack face validity'' and recommended that CMS not finalize the use of the MRI and CT scan CCRs.

    Response: We appreciate the input that stakeholders have provided in response to the request for comment on how to improve the use of nonstandard cost center codes. As discussed in the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24344 through 24346), we noticed inconsistencies in hospital cost reporting of nonstandard cost centers and were concerned about the implication that some of these discrepancies might have on the aspects of the IPPS that rely on CCRs. However, we did not propose any changes to the methodology or data sources for the FY 2016 CCRs and relative weights.

    We appreciate the request that CMS provide more detailed instructions regarding appropriate cost reporting methodologies. We believe that the desire for more specific direction in how to report should be balanced by the need for flexibility in cost reporting based on each hospital's own internal charge structure. That balance also applies to cost allocation methodologies. As discussed in the FY 2014 IPPS/LTCH PPS final rule (78 FR 50523) and in the FY 2011 IPPS/LTCH PPS final rule (75 FR 50077 through 50079), we encouraged hospitals over the past several years to use the most precise cost reporting methods in response to the new cost report lines such as the MRI and CT scan standard

    Page 49350

    cost centers, which, in most cases, corresponded to the recommended cost allocation statistic. We believe that more precise cost allocation could mitigate concerns related to the accuracy of the MRI and CT scan CCRs. However, we recognized that hospitals have varying resources and capability for assigning costs and charges on the cost report, which is why in most cases we have allowed greater flexibility. As commenters noted, an instance in which we have specifically provided guidance was in connection with the decision to split the cost center for Medical Supplies Charged to Patients into one line for ``Medical Supplies Charged to Patients'' and another line for ``Implantable Devices Charged to Patients,'' where we listed the revenue codes for which charges would properly be associated with these two cost centers (we refer readers to the FY 2009 IPPS/LTCH PPS final rule (73 FR 48462 through 48463). For that specific change to address charge compression in the ``Medical Supplies'' cost center, the separation between the types of services associated with each cost center is more distinct and therefore more easily identifiable by revenue code, which may not be true of all nonstandard and standard cost centers. Regarding the comments stating that use of distinct CCRs for MRI and CT scans produce ``payment rates that lack face validity'' and that CMS not finalize use of the MRI and CT scan CCRs, we note that we did not make any proposals regarding the use of the MRI and CT scans in particular in the relative weights calculation for FY 2016. As we have done since FY 2014, we are using the MRI and CT scan CCRs to calculate the IPPS relative weights for FY 2016. We also note that we have previously addressed stakeholder concerns related to the CT scan and MRI standard cost centers in setting the IPPS relative weights. For a detailed discussion of the CT scan and MRI standard cost centers, we refer readers to the FY 2014 IPPS/LTCH PPS final rule (78 FR 50520 through 50523), and the FY 2011 IPPS/LTCH PPS final rule (75 FR 50077 through 50079).

    We appreciate the comments that stakeholders submitted and will continue to explore ways in which we can improve the accuracy of the cost report data and calculated CCRs used in the cost estimation process. To the extent possible, we will continue to seek stakeholder input in efforts to limit the impact on providers. In the interim, while we are considering these public comments, as we proposed, we are using the 19 CCRs for FY 2016 (listed in section II.H.3. of the preamble of this final rule) that were calculated from the March 2015 update of the FY 2013 HCRIS, created in accordance with CMS' current longstanding procedures for mapping and rolling up nonstandard cost center codes. As we did with the FY 2015 IPPS/LTCH PPS final rule, we are providing the version of the HCRIS from which we calculated these 19 CCRs on the FY 2016 IPPS Final Rule Home Page at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2016-IPPS-Final-Rule-Home-Page.html.\3\

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

    \3\ Ibid.

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    F. Adjustment to MS-DRGs for Preventable Hospital-Acquired Conditions (HACs), Including Infections for FY 2016

    1. Background

    Section 1886(d)(4)(D) of the Act addresses certain hospital-

    acquired conditions (HACs), including infections. This provision is part of an array of Medicare tools that we are using to promote increased quality and efficiency of care. Under the IPPS, hospitals are encouraged to treat patients efficiently because they receive the same DRG payment for stays that vary in length and in the services provided, which gives hospitals an incentive to avoid unnecessary costs in the delivery of care. In some cases, conditions acquired in the hospital do not generate higher payments than the hospital would otherwise receive for cases without these conditions. To this extent, the IPPS encourages hospitals to avoid complications.

    However, the treatment of these conditions can generate higher Medicare payments in two ways. First, if a hospital incurs exceptionally high costs treating a patient, the hospital stay may generate an outlier payment. However, because the outlier payment methodology requires that hospitals experience large losses on outlier cases before outlier payments are made, hospitals have an incentive to prevent outliers. Second, under the MS-DRG system that took effect in FY 2008 and that has been refined through rulemaking in subsequent years, certain conditions can generate higher payments even if the outlier payment requirements are not met. Under the MS-DRG system, there are currently 261 sets of MS-DRGs that are split into 2 or 3 subgroups based on the presence or absence of a complication or comorbidity (CC) or a major complication or comorbidity (MCC). The presence of a CC or an MCC generally results in a higher payment.

    Section 1886(d)(4)(D) of the Act specifies that, by October 1, 2007, the Secretary was required to select, in consultation with the Centers for Disease Control and Prevention (CDC), at least two conditions that: (a) Are high cost, high volume, or both; (b) are assigned to a higher paying MS-DRG when present as a secondary diagnosis (that is, conditions under the MS-DRG system that are CCs or MCCs); and (c) could reasonably have been prevented through the application of evidence-based guidelines. Section 1886(d)(4)(D) of the Act also specifies that the list of conditions may be revised, again in consultation with the CDC, from time to time as long as the list contains at least two conditions.

    Effective for discharges occurring on or after October 1, 2008, under the authority of section 1886(d)(4)(D) of the Act, Medicare no longer assigns an inpatient hospital discharge to a higher paying MS-

    DRG if a selected condition is not present on admission (POA). Thus, if a selected condition that was not POA manifests during the hospital stay, it is considered a HAC and the case is paid as though the secondary diagnosis was not present. However, even if a HAC manifests during the hospital stay, if any nonselected CC or MCC appears on the claim, the claim will be paid at the higher MS-DRG rate. In addition, Medicare continues to assign a discharge to a higher paying MS-DRG if a selected condition is POA. When a HAC is not POA, payment can be affected in a manner shown in the diagram below.

    Page 49351

    GRAPHIC TIFF OMITTED TR17AU15.000

    2. HAC Selection

    Beginning in FY 2007, we have set forth proposals, and solicited and responded to public comments, to implement section 1886(d)(4)(D) of the Act through the IPPS annual rulemaking process. For specific policies addressed in each rulemaking cycle, including a detailed discussion of the collaborative interdepartmental process and public input regarding selected and potential candidate HACs, we refer readers to the following rules: The FY 2007 IPPS proposed rule (71 FR 24100) and final rule (71 FR 48051 through 48053); the FY 2008 IPPS proposed rule (72 FR 24716 through 24726) and final rule with comment period (72 FR 47200 through 47218); the FY 2009 IPPS proposed rule (73 FR 23547) and final rule (73 FR 48471); the FY 2010 IPPS/RY 2010 LTCH PPS proposed rule (74 FR 24106) and final rule (74 FR 43782); the FY 2011 IPPS/LTCH PPS proposed rule (75 FR 23880) and final rule (75 FR 50080); the FY 2012 IPPS/LTCH PPS proposed rule (76 FR 25810 through 25816) and final rule (76 FR 51504 through 51522); the FY 2013 IPPS/LTCH PPS proposed rule (77 FR 27892 through 27898) and final rule (77 FR 53283 through 53303); the FY 2014 IPPS/LTCH PPS proposed rule (78 FR 27509 through 27512) and final rule (78 FR 50523 through 50527), and the FY 2015 IPPS/LTCH PPS proposed rule (79 FR 28000 through 28003) and final rule (79 FR 49876 through 49880). A complete list of the 14 current categories of HACs is included on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalAcqCond/Hospital-Acquired_Conditions.html.

    3. Present on Admission (POA) Indicator Reporting

    Collection of POA indicator data is necessary to identify which conditions were acquired during hospitalization for the HAC payment provision as well as for broader public health uses of Medicare data. In previous rulemaking, we provided both CMS and CDC Web site resources that are available to hospitals for assistance in this reporting effort. For detailed information regarding these sites and materials, including the application and use of POA indicators, we refer the reader to the FY 2012 IPPS/LTCH PPS final rule (76 FR 51506 through 51507).

    Currently, as we have discussed in the prior rulemaking cited under section II.I.2. of the preamble of this final rule, the POA indicator reporting requirement only applies to IPPS hospitals and Maryland hospitals because they are subject to this HAC provision. Non-IPPS hospitals, including CAHs, LTCHs, IRFs, IPFs, cancer hospitals, children's hospitals, RNHCIs, and the Department of Veterans Affairs/

    Department of Defense hospitals, are exempt from POA reporting.

    There are currently four POA indicator reporting options, ``Y'', ``W'', ``N'', and ``U'', as defined by the ICD-9-CM Official Guidelines for Coding and Reporting. We note that prior to January 1, 2011, we also used a POA indicator reporting option ``1''. However, beginning on or after January 1, 2011, hospitals were required to begin reporting POA indicators using the 5010 electronic transmittal standards format. The 5010 format removes the need to report a POA indicator of ``1'' for codes that are exempt from POA reporting. We issued CMS instructions on this reporting change as a One-Time Notification, Pub. No. 100-20, Transmittal No. 756, Change Request 7024, effective on August 13, 2010, which can be located at the following link on the CMS Web site: http://www.cms.gov/manuals/downloads/Pub100_20.pdf. The current POA indicators and their descriptors are shown in the chart below:

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

    Indicator Descriptor

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

    Y.......................... Indicates that the condition was present on

    admission.

    W.......................... Affirms that the hospital has determined

    that, based on data and clinical judgment,

    it is not possible to document when the

    onset of the condition occurred.

    N.......................... Indicates that the condition was not

    present on admission.

    U.......................... Indicates that the documentation is

    insufficient to determine if the condition

    was present at the time of admission.

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

    Page 49352

    Under the HAC payment policy, we treat HACs coded with ``Y'' and ``W'' indicators as POA and allow the condition on its own to cause an increased payment at the CC and MCC level. We treat HACs coded with ``N'' and ``U'' indicators as Not Present on Admission (NPOA) and do not allow the condition on its own to cause an increased payment at the CC and MCC level. We refer readers to the following rules for a detailed discussion of POA indicator reporting: The FY 2009 IPPS proposed rule (73 FR 23559) and final rule (73 FR 48486 through 48487); the FY 2010 IPPS/RY 2010 LTCH PPS proposed rule (74 FR 24106) and final rule (74 FR 43784 through 43785); the FY 2011 IPPS/LTCH PPS proposed rule (75 FR 23881 through 23882) and final rule (75 FR 50081 through 50082); the FY 2012 IPPS/LTCH PPS proposed rule (76 FR 25812 through 25813) and final rule (76 FR 51506 through 51507); the FY 2013 IPPS/

    LTCH PPS proposed rule (77 FR 27893 through 27894) and final rule (77 FR 53284 through 53285); the FY 2014 IPPS/LTCH PPS proposed rule (78 FR 27510 through 27511) and final rule (78 FR 50524 through 50525), and the FY 2015 IPPS/LTCH PPS proposed rule (79 FR 28001 through 28002) and final rule (79 FR 49877 through 49878).

    In addition, as discussed previously in the FY 2013 IPPS/LTCH PPS final rule (77 FR 53324), the 5010 format allows the reporting and, effective January 1, 2011, the processing of up to 25 diagnoses and 25 procedure codes. As such, it is necessary to report a valid POA indicator for each diagnosis code, including the principal diagnosis and all secondary diagnoses up to 25.

    4. HACs and POA Reporting in Preparation for Transition to ICD-10-CM and ICD-10-PCS

    In the FY 2012 IPPS/LTCH PPS final rule (76 FR 51506 and 51507), in preparation for the transition to the ICD-10-CM and ICD-10-PCS code sets, we indicated that further information regarding the use of the POA indicator with the ICD-10-CM/ICD-10-PCS classifications as they pertain to the HAC policy would be discussed in future rulemaking.

    At the March 5, 2012 and the September 19, 2012 meetings of the ICD-9-CM Coordination and Maintenance Committee, an announcement was made with regard to the availability of the ICD-9-CM HAC list translation to ICD-10-CM and ICD-10-PCS code sets. Participants were informed that the list of the ICD-9-CM selected HACs had been translated into codes using the ICD-10-CM and ICD-10-PCS classification system. It was recommended that the public review this list of ICD-10-

    CM/ICD-10-PCS code translations of the selected HACs available on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-Project.html. We encouraged the public to submit comments on these translations through the HACs Web page using the CMS ICD-10-CM/PCS HAC Translation Feedback Mailbox that was set up for this purpose under the Related Links section titled ``CMS HAC Feedback.'' We also encouraged readers to review the educational materials and draft code sets available for ICD-10-CM/PCS on the CMS Web site at: http://www.cms.gov/ICD10/. Lastly, we provided information regarding the ICD-

    10 MS-DRG Conversion Project on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalAcqCond/icd10_hacs.html.

    In the FY 2014 IPPS/LTCH PPS final rule (78 FR 50525), we stated that the final HAC list translation from ICD-9-CM to ICD-10-CM/ICD-10-

    PCS would be subject to formal rulemaking. We again encouraged readers to review the educational materials and updated draft code sets available for ICD-10-CM/ICD-10-PCS on the CMS Web site at: http://www.cms.gov/ICD10/. In addition, we stated that the draft ICD-10-CM Coding Guidelines could be viewed on the CDC Web site at: http://www.cdc.gov/nchs/icd/icd10cm.htm.

    However, prior to engaging in rulemaking for the FY 2015 DRA HAC program, on April 1, 2014, the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93) was enacted, which specified that the Secretary may not adopt ICD-10 prior to October 1, 2015. Accordingly, the U.S. Department of Health and Human Services released a final rule in the Federal Register on August 4, 2014 (79 FR 45128 through 45134) that included a new compliance date that requires the use of ICD-10 beginning October 1, 2015. The August 4, 2014 final rule is available for viewing on the Internet at: http://www.gpo.gov/fdsys/pkg/FR-2014-08-04/pdf/2014-18347.pdf. That final rule also requires HIPAA covered entities to continue to use ICD-9-CM through September 30, 2015. Further information on the ICD-10 rules can be found on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD10/Statute_Regulations.html.

    As described in section II.F.5. of the preamble of this final rule, we are implementing the HAC list translations from ICD-9-CM to ICD-10-

    CM/ICD-10-PCS in this FY 2016 IPPS/LTCH PPS final rule.

    5. Changes to the HAC Program for FY 2016

    As discussed in section II.G. 1. a. of the preamble of this final rule, for FY 2016, we are implementing the ICD-10 MS-DRGs Version 33 as the replacement logic for the ICD-9-CM MS-DRGs Version 32. As part of our DRA HAC update for FY 2016, we proposed to implement the ICD-10-CM/

    PCS Version 33 HAC list to replace the ICD-9-CM Version 32 HAC list.

    CMS prepared the ICD-10 MS-DRGs Version 32 based on the FY 2015 MS-

    DRGs (Version 32) that we finalized in the FY 2015 IPPS/LTCH PPS final rule. In November 2014, we posted a Definitions Manual of the ICD-10 MS-DRGs Version 32 on the ICD-10 MS-DRG Conversion Project Web site at: http://www.cms.hhs.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-Project.html. The HAC code list translations from ICD-9-CM to ICD-10-

    CM/PCS are located in Appendix I of the ICD-10-CM/PCS MS-DRG Version 32 Definitions Manual. The link to this Manual (available in both text and HTML formats) is located in the Downloads section of the ICD-10 MS-DRG Conversion Project Web site.

    In the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24348 through 24349), we solicited public comments on how well the ICD-10-CM/PCS Version 32 HAC list replicates the ICD-9-CM Version 32 HAC list. We did not receive any public comments on our list of ICD-10 translations for the HAC list. Therefore, we are finalizing our proposal to implement the ICD-10-CM/PCS Version 33 HAC list to replace the ICD-9-CM Version 32 HAC list.

    With respect to the current categories of the HACs, in the FY 2016 IPPS/LTCH PPS proposed rule, we did not propose to add or remove any categories for FY 2016.

    Comment: Two commenters suggested that CMS expand the current HAC category of Iatrogenic Pneumothorax with Venous Catheterization to include Iatrogenic Pneumothorax with Thoracentesis and to also add Accidental Puncture/Bleeding with Paracentesis as a HAC category. The commenters cited various studies and asserted that both of these conditions satisfy the established criteria of being high cost, high volume, or both; being assigned to a higher paying MS-DRG when present as a secondary diagnosis (that is, conditions under the MS-DRG system that are CCs or MCCs); and could reasonably have been prevented through the application of evidence-based guidelines. Both commenters also listed a series of ICD-10-CM and ICD-10-PCS

    Page 49353

    codes that they requested CMS to consider for inclusion in each of these recommended new HAC categories. The commenters believed that adding these two conditions would improve patient care and result in cost savings to the Medicare program.

    Response: We recognize and appreciate the commenters' recommendations for refinements to the HAC list. We also thank the commenters for their commitment to working with CMS on reducing complications resulting in better patient care and cost savings. In the FY 2015 IPPS/LTCH PPS final rule (79 FR 49879), we responded to similar comments and noted that we would take them under consideration for future rulemaking. While we did not propose to expand or add these specific HAC categories (Iatrogenic Pneumothorax with Thoracentesis and Accidental Puncture/Bleeding with Paracentesis) for FY 2016, in response to a public comment received last year, we did engage our contractor, RTI, to begin researching available evidence-based guidelines for these conditions. As discussed in section II.F.7. of the preamble to this final rule, RTI has completed their annual evidence-

    based guidelines report and, in addition, has developed a separate excerpt report that summarizes the two conditions recommended by the commenters under consideration. We encourage readers to review the separate document titled, ``Evidence-based Guidelines Pertaining to Select Thoracentesis- and Paracentesis-Related Conditions,'' which is available via the Internet on the CMS Hospital-Acquired Conditions Web page in the ``Downloads'' section at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalAcqCond/index.html?redirect=/

    HospitalAcqCond/ We reiterate that we continue to encourage public dialogue about refinements to the HAC list through written stakeholder comments.

    We were unable to fully evaluate each of these two recommended conditions against all the established criteria, as well as review the references the commenters submitted, or perform detailed analysis of the ICD-10 codes that the commenters listed in time for discussion in this FY 2016 IPPS/LTCH PPS final rule. However, we intend to consider these public comments as we develop proposed changes to the HAC-POA program for FY 2017.

    Comment: One commenter urged CMS to remove the Falls and Trauma HAC category from the HAC-POA program. The commenter stated that the statutory criterion that a condition could reasonably have been prevented through the application of evidence-based guidelines is not met for preventing falls. The commenter also stated that this HAC may lead to unintended consequences such as ``creating an epidemic of immobility in hospitals'' and excessive orders for bed rest and motion detection devices. The commenter recommended that CMS develop quality measures and incentivize hospitals to create Acute Care for Elders (ACE) units that focus on this specific population as another option. According to the commenter, studies of the ACE initiative determined better outcomes. For example, the commenter noted results of the ACE program model indicated a reduction in falls, delirium, and functional decline for patients, as well as shorter lengths of stay in a hospital, a decrease in the number of discharges to a nursing home, a reduction in 30-day readmissions, and reduced health care costs.

    Response: We acknowledge the commenter's comments regarding the Falls and Trauma HAC category. With respect to the commenter's statement that one of the statutory criteria (that is, could reasonably have been prevented through the application of evidence-based guidelines) is not being met for the prevention of falls, we note that, as mentioned in response to an earlier comment, our contractor, RTI, has completed the 2015 Report for Evidence-Based Guidelines, which is available via the Internet on the CMS Hospital-Acquired Conditions Web page in the ``Downloads'' section at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalAcqCond/index.html?redirect=/

    HospitalAcqCond/. We further note that evidence-based guidelines for falls prevention exist and refer the reader to the findings in this report directly related to falls. We also point out that, while the commenter requested the removal of the entire Falls and Trauma HAC category, falls are only one component (or condition) in the HAC category. The Falls and Trauma HAC category also includes conditions related to trauma, such as intracranial injuries, crushing injuries, burns, and other injuries (for example, frostbite, heat stroke, drowning, and suffocation). Therefore, we do not agree with the commenter's suggestion to remove the Falls and Trauma HAC category from the HAC-POA program.

    In response to the commenter's recommendation that CMS establish quality measures and incentive payments for hospitals, we point out that currently, under various CMS quality reporting programs, there are measures specifically related to falls. On October 6, 2014, the Improving Medicare Post-Acute Care Transformation Act of 2014 (the IMPACT Act) (Pub. L. 113-185) was enacted, which specified under section 1899B(c)(1) of the Act that the Secretary shall require postacute care providers to report data on quality measures relating to functional status, skin integrity, medication reconciliation and incidence of major falls. Prior to the IMPACT Act, the NQF #0674 measure, Percent of Residents Experiencing One or More Falls with Major Injury (Long Stay), was finalized in the LTCHQR Program and the IRF QR Program. As such, we believe these measures specified in the IMPACT Act align with the CMS Quality Strategy,\4\ which incorporates the three broad aims of the National Quality Strategy \5\:

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    \4\ Available at: http://www.coms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/CMS-Quality-Strategy.html.

    \5\ Available at: http://www.ahrq.gov/workingforquality/nqs/nqs2011annlrpt.html.

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    Better Care: Improve the overall quality of care by making healthcare more patient-centered, reliable, accessible and safe;

    Healthy People, Healthy Communities: Improve the health of the U.S. population by supporting proven interventions to address behavioral, social and environmental determinants of health in addition to delivering higher-quality care; and

    Affordable Care: Reduce the cost of quality healthcare for individuals, families, employers, and government.

    Comment: One commenter requested that CMS incorporate untreated malnutrition, including disease-related malnutrition, as a HAC category. The commenter indicated there are three common types of malnutrition diagnoses that can be attributed to adults in healthcare settings: (1) Starvation-relation malnutrition; (2) chronic disease-

    related malnutrition; and (3) acute disease or injury-related malnutrition. The commenter also noted that hospital-acquired malnutrition from inadequate feeding practices is widespread. According to the commenter, screening patients for the detection of malnutrition allows for further follow-up sessions if warranted. In addition, the commenter stated that, through the process of early detection, the prevention and treatment for disease-related malnutrition will lead to improved outcomes such as patients acquiring fewer complications, hospitalizations, and readmissions.

    The commenter suggested that CMS also advocate for the creation of quality measures that encourage nutrition screening, assessment, and intervention to be included in various quality

    Page 49354

    reporting programs or other agency initiatives that focus on measuring quality of care.

    Response: We appreciate the commenter's suggestion. As stated previously, we did not propose to add or remove any HAC categories for FY 2016. Therefore, we will consider this topic for future rulemaking. We encourage the commenter to submit the specific list of conditions, including the ICD-10 coded data identifying the various types of malnutrition that the commenter is recommending as a candidate condition, along with any additional supporting documentation, for the other established criteria for a HAC as referenced earlier in this section.

    With regard to the commenter's recommendation to develop quality measures related to malnutrition in other quality reporting programs, we note that the quality reporting programs that involve measures are separate and distinct from the Deficit Reduction Act (DRA) HAC program. We refer the reader to section VII. of this FY 2016 IPPS/LTCH PPS final rule for information related to those programs.

    We also refer readers to section II.F.6. of the FY 2008 IPPS final rule with comment period (72 FR 47202 through 47218) and to section II.F.7. of the FY 2009 IPPS final rule (73 FR 48774 through 48491) for detailed discussion supporting our determination regarding each of the current conditions. We refer readers to the FY 2013 IPPS/LTCH PPS proposed rule (77 FR 27892 through 27898) and final rule (77 FR 53285 through 53292) for the HAC policy for FY 2013, the FY 2014 IPPS/LTCH PPS proposed rule (78 FR 27509 through 27512) and final rule (78 FR 50523 through 50527) for the HAC policy for FY 2014, and the FY 2015 IPPS/LTCH PPS proposed rule (79 FR 28000 through 28003) and final rule (79 FR 49876 through 49880) for the HAC policy for FY 2015.

    After consideration of the public comments we received, as we proposed, we are not adding or removing any HAC categories for FY 2016. However, as described more fully in section III.F.7. of the preamble of this final rule, we will continue to monitor contemporary evidence-

    based guidelines for selected, candidate, and previously considered HACs that provide specific recommendations for the prevention of the corresponding conditions in the acute hospital setting and may use this information to inform future rulemaking. In addition, we continue to encourage public dialogue about refinements to the HAC list through written stakeholder comments.

    6. RTI Program Evaluation

    On September 30, 2009, a contract was awarded to RTI to evaluate the impact of the Hospital-Acquired Condition-Present on Admission (HAC-POA) provisions on the changes in the incidence of selected conditions, effects on Medicare payments, impacts on coding accuracy, unintended consequences, and infection and event rates. This was an intra-agency project with funding and technical support from CMS, OPHS, AHRQ, and CDC. The evaluation also examined the implementation of the program and evaluated additional conditions for future selection. The contract with RTI ended on November 30, 2012. Summary reports of RTI's analysis of the FYs 2009, 2010, and 2011 Med PAR data files for the HAC-POA program evaluation were included in the FY 2011 IPPS/LTCH PPS final rule (75 FR 50085 through 50101), the FY 2012 IPPS/LTCH PPS final rule (76 FR 51512 through 51522), and the FY 2013 IPPS/LTCH PPS final rule (77 FR 53292 through 53302). Summary and detailed data also were made publicly available on the CMS Web site at: http://www.cms.gov/HospitalAcqCond/01_Overview.asp and the RTI Web site at: http://www.rti.org/reports/cms/.

    In addition to the evaluation of HAC and POA Med PAR claims data, RTI also conducted analyses on readmissions due to HACs, the incremental costs of HACs to the health care system, a study of spillover effects and unintended consequences, as well as an updated analysis of the evidence-based guidelines for selected and previously considered HACs. Reports on these analyses have been made publicly available on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalAcqCond/index.html.

    7. RTI Reports on Evidence-Based Guidelines

    The RTI program evaluation included a report that provided references for all evidence-based guidelines available for each of the selected, candidate, and previously considered HACs that provided specific recommendations for the prevention of the corresponding conditions. Guidelines were primarily identified using the AHRQ National Guidelines Clearing House (NGCH) and the CDC, along with relevant professional societies. Guidelines published in the United States were used, if available. In the absence of U.S. guidelines for a specific condition, international guidelines were included.

    RTI prepared a final report to summarize its findings regarding these guidelines. This report is titled ``Evidence-Based Guidelines for Selected, Candidate, and Previously Considered Hospital-Acquired Conditions'' and can be found on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalAcqCond/Downloads/Evidence-Based-Guidelines.pdf.

    Subsequent to this final report, RTI was awarded a new Evidence-

    Based Guidelines Monitoring contract. Under this monitoring contract, RTI annually provides a summary report of the contemporary evidence-

    based guidelines for selected, candidate, and previously considered HACs that provide specific recommendations for the prevention of the corresponding conditions in the acute care hospital setting. We received RTI's 2015 report and are making it available to the public on the CMS Hospital-Acquired Conditions Web page in the ``Downloads'' section at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalAcqCond/index.html?redirect=/HospitalAcqCond/.

    G. Changes to Specific MS-DRG Classifications

    1. Discussion of Changes to Coding System and Basis for MS-DRG Updates

  187. Conversion of MS-DRGs to the International Classification of Diseases, 10th Revision (ICD-10)

    Providers use the code sets under the ICD-9-CM coding system to report diagnoses and procedures for Medicare hospital inpatient services under the MS-DRG system. A later coding edition, the ICD-10 coding system, includes the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) for diagnosis coding and the International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS) for inpatient hospital procedure coding, as well as the Official ICD-10-CM and ICD-10-PCS Guidelines for Coding and Reporting. The ICD-10 coding system was initially adopted for transactions conducted on or after October 1, 2013, as described in the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Administrative Simplification: Modifications to Medical Data Code Set Standards to Adopt ICD-10-CM and ICD-10-PCS Final Rule published in the Federal Register on January 16, 2009 (74 FR 3328 through 3362) (hereinafter referred to as the ``ICD-10-CM and ICD-10-PCS final rule''). However, the Secretary of

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    Health and Human Services issued a final rule that delayed the compliance date for ICD-10 from October 1, 2013, to October 1, 2014. That final rule, entitled ``Administrative Simplification: Adoption of a Standard for a Unique Health Plan Identifier; Addition to the National Provider Identifier Requirements; and a Change to the Compliance Date for ICD-10-CM and ICD-10-PCS Medical Data Code Sets,'' CMS-0040-F, was published in the Federal Register on September 5, 2012 (77 FR 54664) and is available for viewing on the Internet at: http://www.gpo.gov/fdsys/pkg/FR-2012-09-05/pdf/2012-21238.pdf. On April 1, 2014, the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93) was enacted, which specified that the Secretary may not adopt ICD-10 prior to October 1, 2015. Accordingly, the U.S. Department of Health and Human Services released a final rule in the Federal Register on August 4, 2014 (79 FR 45128 through 45134) that included a new compliance date that requires the use of ICD-10 beginning October 1, 2015. The August 4, 2014 final rule is available for viewing on the Internet at: http://www.gpo.gov/fdsys/pkg/FR-2014-08-04/pdf/2014-18347.pdf. That final rule also requires HIPAA covered entities to continue to use ICD-9-CM through September 30, 2015.

    The anticipated move to ICD-10 necessitated the development of an ICD-10-CM/ICD-10-PCS version of the MS-DRGs. CMS began a project to convert the ICD-9-CM-based MS-DRGs to ICD-10 MS-DRGs. In response to the FY 2011 IPPS/LTCH PPS proposed rule, we received public comments on the creation of the ICD-10 version of the MS-DRGs, which will be implemented at the same time as ICD-10 (75 FR 50127 and 50128). While we did not propose an ICD-10 version of the MS-DRGs in the FY 2011 IPPS/LTCH PPS proposed rule, we noted that we have been actively involved in converting current MS-DRGs from ICD-9-CM codes to ICD-10 codes and sharing this information through the ICD-10 (previously ICD-

    9-CM) Coordination and Maintenance Committee. We undertook this early conversion project to assist other payers and providers in understanding how to implement their own conversion projects. We posted ICD-10 MS-DRGs based on Version 26.0 (FY 2009) of the MS-DRGs. We also posted a paper that describes how CMS went about completing this project and suggestions for other payers and providers to follow. Information on the ICD-10 MS-DRG conversion project can be found on the ICD-10 MS-DRG Conversion Project Web site at: http://www.cms.hhs.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-Project.html. We have continued to keep the public updated on our maintenance efforts for ICD-10-CM and ICD-10-PCS coding systems, as well as the General Equivalence Mappings that assist in conversion through the ICD-10 (previously ICD-9-CM) Coordination and Maintenance Committee. Information on these committee meetings can be found on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/index.html.

    During FY 2011, we developed and posted Version 28 of the ICD-10 MS-DRGs based on the FY 2011 MS-DRGs (Version 28) that we finalized in the FY 2011 IPPS/LTCH PPS final rule on the CMS Web site. This ICD-10 MS-DRGs Version 28 also included the CC Exclusion List and the ICD-10 version of the hospital-acquired conditions (HACs), which was not posted with Version 26. We also discussed this update at the September 15-16, 2010 and the March 9-10, 2011 meetings of the ICD-9-CM Coordination and Maintenance Committee. The minutes of these two meetings are posted on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/index.html.

    We reviewed public comments on the ICD-10 MS-DRGs Version 28 and made updates as a result of these comments. We called the updated version the ICD-10 MS-DRGs Version 28-R1. We posted a Definitions Manual of ICD-10 MS-DRGs Version 28-R1 on our ICD-10 MS-DRG Conversion Project Web site. To make the review of Version 28-R1 updates easier for the public, we also made available pilot software on a CD ROM that could be ordered through the National Technical Information Service (NTIS). A link to the NTIS ordering page was provided on the CMS ICD-10 MS-DRGs Web page. We stated that we believed that, by providing the ICD-10 MS-DRGs Version 28-R1 Pilot Software (distributed on CD ROM), the public would be able to more easily review and provide feedback on updates to the ICD-10 MS-DRGs. We discussed the updated ICD-10 MS-DRGs Version 28-R1 at the September 14, 2011 ICD-9-CM Coordination and Maintenance Committee meeting. We encouraged the public to continue to review and provide comments on the ICD-10 MS-DRGs so that CMS could continue to update the system.

    In FY 2012, we prepared the ICD-10 MS-DRGs Version 29, based on the FY 2012 MS-DRGs (Version 29) that we finalized in the FY 2012 IPPS/LTCH PPS final rule. We posted a Definitions Manual of ICD-10 MS-DRGs Version 29 on our ICD-10 MS-DRG Conversion Project Web site. We also prepared a document that describes changes made from Version 28 to Version 29 to facilitate a review. The ICD-10 MS-DRGs Version 29 was discussed at the ICD-9-CM Coordination and Maintenance Committee meeting on March 5, 2012. Information was provided on the types of updates made. Once again, the public was encouraged to review and comment on the most recent update to the ICD-10 MS-DRGs.

    CMS prepared the ICD-10 MS-DRGs Version 30 based on the FY 2013 MS-

    DRGs (Version 30) that we finalized in the FY 2013 IPPS/LTCH PPS final rule. We posted a Definitions Manual of the ICD-10 MS-DRGs Version 30 on our ICD-10 MS-DRG Conversion Project Web site. We also prepared a document that describes changes made from Version 29 to Version 30 to facilitate a review. We produced mainframe and computer software for Version 30, which was made available to the public in February 2013. Information on ordering the mainframe and computer software through NTIS was posted on the ICD-10 MS-DRG Conversion Project Web site. The ICD-10 MS-DRGs Version 30 computer software facilitated additional review of the ICD-10 MS-DRGs conversion.

    We provided information on a study conducted on the impact of converting MS-DRGs to ICD-10. Information on this study is summarized in a paper entitled ``Impact of the Transition to ICD-10 on Medicare Inpatient Hospital Payments.'' This paper was posted on the CMS ICD-10 MS-DRGs Conversion Project Web site and was distributed and discussed at the September 15, 2010 ICD-9-CM Coordination and Maintenance Committee meeting. The paper described CMS' approach to the conversion of the MS-DRGs from ICD-9-CM codes to ICD-10 codes. The study was undertaken using the ICD-9-CM MS-DRGs Version 27 (FY 2010), which was converted to the ICD-10 MS-DRGs Version 27. The study estimated the impact on aggregate payment to hospitals and the distribution of payments across hospitals. The impact of the conversion from ICD-9-CM to ICD-10 on Medicare MS-DRG hospital payments was estimated using FY 2009 Medicare claims data. The study found a hospital payment increase of 0.05 percent using the ICD-10 MS-DRGs Version 27.

    CMS provided an overview of this hospital payment impact study at the March 5, 2012 ICD-9-CM Coordination and Maintenance Committee meeting.

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    This presentation followed presentations on the creation of ICD-10 MS-

    DRGs Version 29. A summary report of this meeting can be found on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/index.html. At the March 2012 meeting, CMS announced that it would produce an update on this impact study based on an updated version of the ICD-10 MS-DRGs. This update of the impact study was presented at the March 5, 2013 ICD-9-CM Coordination and Maintenance Committee meeting. The study found that moving from an ICD-

    9-CM-based system to an ICD-10 MS-DRG replicated system would lead to DRG reassignments on only 1 percent of the 10 million MedPAR sample records used in the study. Ninety-nine percent of the records did not shift to another MS-DRG when using an ICD-10 MS-DRG system. For the 1 percent of the records that shifted, 45 percent of the shifts were to a higher weighted MS-DRG, while 55 percent of the shifts were to lower weighted MS-DRGs. The net impact across all MS-DRGs was a reduction by 4/10000 or minus 4 pennies per $100. The updated paper is posted on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-Project.html under the ``Downloads'' section. Information on the March 5, 2013 ICD-9-CM Coordination and Maintenance Committee meeting can be found on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/ICD-9-CM-C-and-M-Meeting-Materials.html. This update of the impact paper and the ICD-

    10 MS-DRG Version 30 software provided additional information to the public who were evaluating the conversion of the MS-DRGs to ICD-10 MS-

    DRGs.

    CMS prepared the ICD-10 MS-DRGs Version 31.0 based on the FY 2014 MS-DRGs (Version 31) that we finalized in the FY 2014 IPPS/LTCH PPS final rule. In November 2013, we posted a Definitions Manual of the ICD-10 MS-DRGs Version 31 on the ICD-10 MS-DRG Conversion Project Web site at: http://www.cms.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-Project.html. We also prepared a document that described changes made from Version 30 to Version 31 to facilitate a review. We produced mainframe and computer software for Version 31, which was made available to the public in December 2013. Information on ordering the mainframe and computer software through NTIS was posted on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-Project.html under the ``Related Links'' section. This ICD-

    10 MS-DRGs Version 31 computer software facilitated additional review of the ICD-10 MS-DRGs conversion. We encouraged the public to submit to CMS any comments on areas where they believed the ICD-10 MS-DRGs did not accurately reflect grouping logic found in the ICD-9-CM MS-DRGs Version 31.

    We reviewed public comments received and developed an update of ICD-10 MS-DRGs Version 31, which we called ICD-10 MS-DRGs Version 31.0-

    R. We made available a Definitions Manual of the ICD-10 MS-DRGs Version 31.0-R on the ICD-10 MS-DRG Conversion Project Web site at: http://www.cms.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-Project.html. We also prepared a document that describes changes made from Version 31 to Version 31-R to facilitate a review. We will continue to share ICD-10-MS-DRG conversion activities with the public through this Web site.

    CMS prepared the ICD-10 MS-DRGs Version 32 based on the FY 2015 MS-

    DRGs (Version 32) that we finalized in the FY 2015 IPPS/LTCH PPS final rule. In November 2014, we made available a Definitions Manual of the ICD-10 MS DRGs Version 32 on the ICD-10 MS-DRG Conversion Project Web site at: http://www.cms.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-Project.html. We also prepared a document that described changes made from Version 31-R to Version 32 to facilitate a review. We produced mainframe and computer software for Version 32, which was made available to the public in January 2015. Information on ordering the mainframe and computer software through NTIS was made available on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-Project.html under the ``Related Links'' section. This ICD-10 MS-DRGs Version 32 computer software facilitated additional review of the ICD-10 MS-DRGs conversion. We encouraged the public to submit to CMS any comments on areas where they believed the ICD-10 MS-

    DRGs did not accurately reflect grouping logic found in the ICD-9-CM MS-DRGs Version 32. We discuss five requests from the public to update the ICD-10 MS-DRGs Version 32 to better replicate the ICD-9-CM MS-DRGs in section II.G.3., 4., and 5. of the preamble of this FY 2016 IPPS/

    LTCH PPS final rule. In the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24351), we proposed to implement the MS-DRG code logic in the ICD-10 MS-DRGs Version 32 along with any finalized updates to the ICD-10 MS-

    DRGs Version 32 for the final ICD-10 MS-DRGs Version 33. In the proposed rule, we proposed the ICD-10 MS-DRGs Version 33 as the replacement logic for the ICD-9-CM based MS-DRGs Version 32 as part of the proposed MS-DRG updates for FY 2016. We invited public comments on how well the ICD-10 MS-DRGs Version 32 replicates the logic of the MS-

    DRGs Version 32 based on ICD-9-CM codes.

    Comment: One commenter addressed an ICD-10 MS-DRG replication issue regarding the procedure code designation and MS-DRG assignment of two ICD-10-PCS codes in the ICD-10 MS-DRGs Version 32 Definitions Manual under Appendix E--Operating Room Procedures and Procedure Code MS-DRG Index. The commenter agreed with CMS that the two ICD-10-PCS codes identified in the FY 2016 IPPS/LTCH PPS proposed rule, 02HQ30Z (Insertion of pressure sensor monitoring device into right pulmonary artery, percutaneous approach) and 02HR30Z (Insertion of pressure sensor monitoring device into left pulmonary artery, percutaneous approach), were appropriate translations for ICD-9-CM procedure code 38.26 (Insertion of implantable wireless pressure sensor without lead for intracardiac or great vessel hemodynamic monitoring), which identifies the CardioMEMSTM HF Monitoring System (80 FR 24426). However, the commenter noted that, under the ICD-9-CM based MS-

    DRGs Version 32 logic, procedure code 38.26 is designated as an operating room (O.R.) procedure for MS-DRG assignment and group to MS-

    DRG 264 (Other Circulatory O.R. Procedures), while under the ICD-10 based MS-DRGs Version 32 logic, the two ICD-10-PCS code translations are not recognized as O.R. procedures for purposes of MS-DRG assignment. Therefore, the commenter requested that the two ICD-10-PCS codes be designated as O.R. procedures within Appendix E of the ICD-10 MS-DRG Definitions Manual and group to ICD-10 MS-DRG 264 to accurately replicate the ICD-9-CM MS-DRG Version 32 logic.

    Response: We agree with the commenter that this is an ICD-10 MS-DRG replication error. ICD-10-PCS codes 02HQ30Z and 02HR30Z, along with the other ICD-10-PCS codes describing the insertion of a pressure sensor monitoring device that are also appropriate translations for ICD-9-CM procedure code 38.26, should be designated as O.R. procedures within Appendix E of the ICD-10 MS-DRG

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    Definitions Manual and assigned to ICD-10 MS-DRG 264 to accurately replicate the ICD-9-CM MS-DRGs Version 32 logic. These other ICD-10-PCS codes describe the insertion of a pressure sensor monitoring device utilizing an open approach or a percutaneous endoscopic approach (for the right or left pulmonary artery). Therefore, to be consistent with the comparable ICD-10-PCS code translations describing a percutaneous approach and to accurately replicate the ICD-9-CM MS-DRGs Version 32 logic for ICD-9-CM procedure code 38.26, the ICD-10-PCS codes listed below that describe the insertion of a pressure sensor monitoring device utilizing an open approach or a percutaneous endoscopic approach (for the right or left pulmonary artery) should also be designated as O.R. procedures and assigned to ICD-10 MS-DRG 264.

    After consideration of the public comments we received, as final policy for the FY 2016 ICD-10 MS-DRGs Version 33, we are designating the following ICD-10-PCS codes as O.R. procedures and assigning them to ICD-10 MS-DRG 264:

    02HQ00Z (Insertion of pressure sensor monitoring device into right pulmonary artery, open approach);

    02HQ30Z (Insertion of pressure sensor monitoring device into right pulmonary artery, percutaneous approach);

    02HQ40Z (Insertion of pressure sensor monitoring device into right pulmonary artery, percutaneous endoscopic approach);

    02HR00Z (Insertion of pressure sensor monitoring device into left pulmonary artery, open approach);

    02HR30Z (Insertion of pressure sensor monitoring device into left pulmonary artery, percutaneous approach); and

    02HR40Z (Insertion of pressure sensor monitoring device into left pulmonary artery, percutaneous endoscopic approach).

    Comment: One commenter addressed an ICD-10 MS-DRG replication issue concerning excisional debridements of deep pressure ulcers of the ankle. The commenter recommended that the following two ICD-10-PCS codes be added to ICD-10 MS-DRG 581 (Other Skin, Subcutaneous Tissue and Breast Procedures without CC/MCC) to accurately replicate the ICD-

    9-CM MS-DRG logic: ICD-10-PCS procedure code 0LBT0ZZ (Excision of left ankle tendon, open approach) and ICD-10-PCS procedure code 0LBS0ZZ (Excision of right ankle tendon, open approach). The commenter stated that the ICD-9-CM procedure codes describing the excisional debridements of pressure ulcers that extend down into the ankle tendon are currently assigned to MS-DRG 581. However, the ICD-10-PCS codes capturing these procedures are not in the ICD-10-PCS MS-DRG 581.

    Response: We agree with the commenter that this is an ICD-10 MS-DRG replication error. ICD-9-CM code 83.39 (Excision of lesion of other soft tissue) captures this procedure and is assigned to ICD-9 MS-DRGs 579, 580, and 581 (Other Skin, Subcutaneous Tissue and Breast Procedures with MCC, with CC, and without CC/MCC, respectively). Therefore, ICD-10-PCS codes 0LBT0ZZ and 0LBS0ZZ also should be assigned to ICD-10 MS-DRGs 579, 580, and 581.

    After consideration of the public comments received, we are assigning ICD-10-PCS procedure codes 0LBT0ZZ (Excision of left ankle tendon, open approach) and 0LBS0ZZ (Excision of right ankle tendon, open approach) to ICD-10 MS-DRGs 579, 580, and 581 (Other Skin, Subcutaneous Tissue and Breast Procedures with MCC, with CC, and without CC/MCC, respectively).

    Comment: One commenter addressing an ICD-10 MS-DRG replication issue requested that CMS add the following four post-delivery procedure codes to the ICD-10 version of MS-DRGs 774 and 775 (Vaginal Delivery with and without Complicating Diagnoses, respectively) under the ``Only Operating Room Procedures'' section. The commenter stated that these codes are currently assigned to the ICD-9-CM version of MS-DRGs 774 and 775.

    0HBJXZZ (Excision of left upper leg skin, external approach);

    0DQR0ZZ (Repair anal sphincter, open approach (3rd degree obstetrical laceration repair);

    OUQJXZZ (Repair clitoris, external approach); and

    0UBMXZZ (Excision of vulva, external approach).

    The following table shows the equivalent ICD-9-CM codes provided by the requestor.

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

    ICD-10-PCS Procedure code ICD-9-CM Procedure code

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

    0UBMXZZ (Excision of vulva, external 71.3 (Other local excision or

    approach). destruction of vulva and

    perineum).

    0DQR0ZZ (Repair anal sphincter, open 75.61(Repair of current

    approach (3rd degree obstetrical obstetric laceration of rectum

    laceration repair). and sphincter ani).

    0UQJXZZ (Repair clitoris, external 75.69 (Repair of current

    approach). obstetric laceration).

    0HBJXZZ (Excision of left upper leg 86.3 (Local excision/

    skin, external approach). destruction of lesion/tissue

    of skin and subcutaneous

    tissues).

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

    Response: We examined the list of post-delivery procedure codes in ICD-9 MS-DRGs 774 and 775 under the ``Only Operating Room Procedures'' section and found that ICD-9-CM procedure code 71.3 is included. Therefore, we agree with the commenter that this oversight is a replication error and that ICD-10-PCS procedure code 0UBMXZZ should be assigned to ICD-10 MS-DRGs 774 and 775 under the ``Only Operating Room Procedures'' section. However, with regard to ICD-9-CM procedure codes 75.61, 75.69, and 86.3, when we examined the list of post-delivery procedure codes in MS-DRGs 774 and 775 under the ``Only Operating Room Procedures'' section, we found that they were not included. Therefore, we disagree with adding ICD-10-PCS codes 0DQR0ZZ, 0UQJXZZ, and 0HBJXZZ to ICD-10 MS-DRGs 774 and 775 under the ``Only operating room Procedures'' section because these procedures are not currently captured in ICD-9 MS-DRGs 774 and 775. The omission of these three ICD-

    10-PCS codes is not an ICD-10 MS-DRG replication error.

    After consideration of the public comments received, we are assigning ICD-10-PCS code 0UBMXZZ (Excision of vulva, external approach) to ICD-10 MS-DRGs 774 and 775 (Vaginal Delivery with and without Complicating Diagnoses, respectively) under the ``Only Operating Room Procedures'' section.

  188. Basis for FY 2016 MS-DRG Updates

    CMS encourages input from our stakeholders concerning the annual IPPS updates when that input is made available to us by December 7 of the year prior to the next annual proposed rule update. For example, to be considered for any updates or changes in FY 2016, comments and suggestions should have been submitted by December 7, 2014. The comments that were submitted in a timely manner for

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    FY 2016 are discussed below in this section.

    Following are the changes we proposed to the MS-DRGs and our finalized policies for FY 2016. We invited public comments on each of the MS-DRG classification proposed changes described below, as well as our proposals to maintain certain existing MS-DRG classifications, which also are discussed below. In some cases, we proposed changes to the MS-DRG classifications based on our analysis of claims data. In other cases, we proposed to maintain the existing MS-DRG classification based on our analysis of claims data. For the FY 2016 proposed rule, our MS-DRG analysis was based on claims data from the December 2014 update of the FY 2014 MedPAR file, which contains hospital bills received through September 30, 2014, for discharges occurring through September 30, 2014. In our discussion of the MS-DRG reclassification changes that follows, we refer to our analysis of claims data from the ``December 2014 update of the FY 2014 MedPAR file.''

    As explained in previous rulemaking (76 FR 51487), in deciding whether to propose and to make further modification to the MS-DRGs for particular circumstances brought to our attention, we consider whether the resource consumption and clinical characteristics of the patients with a given set of conditions are significantly different than the remaining patients in the MS-DRG. We evaluate patient care costs using average costs and lengths of stay and rely on the judgment of our clinical advisors to decide whether patients are clinically distinct or similar to other patients in the MS-DRG. In evaluating resource costs, we consider both the absolute and percentage differences in average costs between the cases we select for review and the remainder of cases in the MS-DRG. We also consider variation in costs within these groups; that is, whether observed average differences are consistent across patients or attributable to cases that are extreme in terms of costs or length of stay, or both. Furthermore, we consider the number of patients who will have a given set of characteristics and generally prefer not to create a new MS-DRG unless it would include a substantial number of cases.

    In our examination of the claims data, we apply the following criteria established in FY 2008 (72 FR 47169) to determine if the creation of a new complication or comorbidity (CC) or major complication or comorbidity (MCC) subgroup within a base MS-DRG is warranted:

    A reduction in variance of costs of at least 3 percent.

    At least 5 percent of the patients in the MS-DRG fall within the CC or MCC subgroup.

    At least 500 cases are in the CC or MCC subgroup.

    There is at least a 20-percent difference in average costs between subgroups.

    There is a $2,000 difference in average costs between subgroups.

    In order to warrant creation of a CC or MCC subgroup within a base MS-DRG, the subgroup must meet all five of the criteria.

    2. MDC 1 (Diseases and Disorders of the Nervous System): Endovascular Embolization (Coiling) Procedures

    We received a request again this year to change the MS-DRG assignment for endovascular embolization (coiling) procedures. This topic was discussed previously in the FY 2015 IPPS/LTCH PPS proposed rule (79 FR 28005 through 28006) and in the FY 2015 IPPS/LTCH PPS final rule (79 FR 49883 through 49886). For FY 2015, we did not change the MS-DRG assignment for endovascular embolization (coiling) procedures.

    After issuance of the FY 2015 IPPS/LTCH PPS final rule, we received a modified request from the commenter asking that CMS consider establishing four new MS-DRGs:

    Recommended MS-DRG XXX (Endovascular Intracranial Embolization Procedures with Principal Diagnosis of Hemorrhage);

    Recommended MS-DRG XXX (Endovascular Intracranial Embolization Procedures without Principal Diagnosis of Hemorrhage with MCC);

    Recommended MS-DRG XXX (Endovascular Intracranial Embolization Procedures without Principal Diagnosis of Hemorrhage with CC); and

    Recommended MS-DRG XXX (Endovascular Intracranial Embolization Procedures without Principal Diagnosis of Hemorrhage without CC/MCC).

    The requestor stated that establishing these new suggested MS-DRGs will promote clinical cohesiveness and resource comparability. The requestor stated that endovascular intracranial and endovascular embolization procedures are not similar to the open craniotomy procedures with which they are currently grouped. The requestor asserted that the differences in costs between endovascular intracranial procedures and open craniotomy procedures are significant, reflecting, for instance, the use of an operating suite versus an interventional vascular catheterization laboratory suite, intensive care and other costs.

    In conjunction with the recommended new MS-DRGs, the requestor recommended that the following ICD-9-CM codes, which include endovascular embolization procedures and additional intracranial procedures, be removed from MS-DRG 020 (Intracranial Vascular Procedures with Principal Diagnosis of Hemorrhage with MCC); MS-DRG 021 (Intracranial Vascular Procedures with Principal Diagnosis of Hemorrhage with CC); MS-DRG 022 (Intracranial Vascular Procedures with Principal Diagnosis of Hemorrhage without CC/MCC); MS-DRG 023 (Craniotomy with Major Device Implant/Acute Complex CNS Principal Diagnosis with MCC or Chemo Implant); MS-DRG 024 (Craniotomy with Major Device Implant/Acute Complex CNS Principal Diagnosis without MCC); MS-

    DRG 025 (Craniotomy & Endovascular Intracranial Procedures with MCC); MS-DRG 026 (Craniotomy & Endovascular Intracranial Procedures with CC); and MS-DRG 027 (Craniotomy & Endovascular Intracranial Procedures without CC/MCC):

    00.62 (Percutaneous angioplasty of intracranial vessel);

    39.72 (Endovascular (total) embolization or occlusion of head and neck vessels);

    39.74 (Endovascular removal of obstruction from head and neck vessel(s));

    39.75 (Endovascular embolization or occlusion of vessel(s) of head or neck using bare coils);

    39.76 (Endovascular embolization or occlusion of vessel(s) of head or neck using bioactive coils); and

    39.79 (Other endovascular procedures on other vessels).

    The requestor asked that the four new requested MS-DRGs be created using these procedure codes. The requestor suggested that the first requested new MS-DRG would be MS-DRG XXX (Endovascular Intracranial Embolization Procedures with Principal Diagnosis of Hemorrhage). The principal diagnoses for hemorrhage would include the same hemorrhage codes in the current MS-DRGs 020, 021, and 022, which are as follows:

    094.87 (Syphilitic ruptured cerebral aneurysm);

    430 (Subarachnoid hemorrhage);

    431 (Intracerebral hemorrhage);

    432.0 (Nontraumatic extradural hemorrhage);

    432.1 (Subdural hemorrhage); and

    432.9 (Unspecified intracranial hemorrhage).

    For this first new requested MS-DRG, the requestor suggested that only the

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    following endovascular embolization procedure codes would be assigned:

    39.72 (Endovascular (total) embolization or occlusion of head and neck vessels);

    39.75 (Endovascular embolization or occlusion of vessel(s) of head or neck using bare coils); and

    39.76 (Endovascular embolization or occlusion of vessel(s) of head or neck using bioactive coils).

    The requestor recommended that the three additional new MS-DRGs would consist of a new base MS-DRG subdivided into three severity levels as follows:

    Recommended MS-DRG XXX (Endovascular Intracranial Embolization Procedures without Principal Diagnosis of Hemorrhage with MCC);

    Recommended MS-DRG XXX (Endovascular Intracranial Embolization Procedures without Principal Diagnosis of Hemorrhage with CC); and

    Recommended MS-DRG XXX (Endovascular Intracranial Embolization Procedures without Principal Diagnosis of Hemorrhage without CC/MCC).

    The requestor suggested that these three new recommended MS-DRGs would have endovascular embolization procedures as well as additional percutaneous and endovascular procedures as listed below:

    00.62 (Percutaneous angioplasty of intracranial vessel);

    39.72 (Endovascular (total) embolization or occlusion of head and neck vessels);

    39.74 (Endovascular removal of obstruction from head and neck vessel(s));

    39.75 (Endovascular embolization or occlusion of vessel(s) of head or neck using bare coils);

    39.76 (Endovascular embolization or occlusion of vessel(s) of head or neck using bioactive coils); and

    39.79 (Other endovascular procedures on other vessels).

    ICD-10-PCS provides the following more detailed codes for endovascular embolization, which are assigned to MS-DRGs 020, 021, 022, 023, 024, 025, 026, and 027 in the ICD-10 MS-DRGs Version 32:

    ICD-10-PCS Codes for Endovascular Embolization Assigned to MS-DRGs 020

    Through 027 in ICD-10 MS-DRGs Version 32

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

    ICD-10-PCS Code Code description

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

    03LG3BZ.................. Occlusion of intracranial artery with

    bioactive intraluminal device, percutaneous

    approach.

    03LG3DZ.................. Occlusion of intracranial artery with

    intraluminal device, percutaneous approach.

    03LG4BZ.................. Occlusion of intracranial artery with

    bioactive intraluminal device, percutaneous

    endoscopic approach.

    03LG4DZ.................. Occlusion of intracranial artery with

    intraluminal device, percutaneous endoscopic

    approach.

    03LH3BZ.................. Occlusion of right common carotid artery with

    bioactive intraluminal device, percutaneous

    approach.

    03LH3DZ.................. Occlusion of right common carotid artery with

    intraluminal device, percutaneous approach.

    03LH4BZ.................. Occlusion of right common carotid artery with

    bioactive intraluminal device, percutaneous

    endoscopic approach.

    03LH4DZ.................. Occlusion of right common carotid artery with

    intraluminal device, percutaneous endoscopic

    approach.

    03LJ3BZ.................. Occlusion of left common carotid artery with

    bioactive intraluminal device, percutaneous

    approach.

    03LJ3DZ.................. Occlusion of left common carotid artery with

    intraluminal device, percutaneous approach.

    03LJ4BZ.................. Occlusion of left common carotid artery with

    bioactive intraluminal device, percutaneous

    endoscopic approach.

    03LJ4DZ.................. Occlusion of left common carotid artery with

    intraluminal device, percutaneous endoscopic

    approach.

    03LK3BZ.................. Occlusion of right internal carotid artery

    with bioactive intraluminal device,

    percutaneous approach.

    03LK3DZ.................. Occlusion of right internal carotid artery

    with intraluminal device, percutaneous

    approach.

    03LK4BZ.................. Occlusion of right internal carotid artery

    with bioactive intraluminal device,

    percutaneous endoscopic approach.

    03LK4DZ.................. Occlusion of right internal carotid artery

    with intraluminal device, percutaneous

    endoscopic approach.

    03LL3BZ.................. Occlusion of left internal carotid artery

    with bioactive intraluminal device,

    percutaneous approach.

    03LL3DZ.................. Occlusion of left internal carotid artery

    with intraluminal device, percutaneous

    approach.

    03LL4BZ.................. Occlusion of left internal carotid artery

    with bioactive intraluminal device,

    percutaneous endoscopic approach.

    03LL4DZ.................. Occlusion of left internal carotid artery

    with intraluminal device, percutaneous

    endoscopic approach.

    03LM3BZ.................. Occlusion of right external carotid artery

    with bioactive intraluminal device,

    percutaneous approach.

    03LM3DZ.................. Occlusion of right external carotid artery

    with intraluminal device, percutaneous

    approach.

    03LM4BZ.................. Occlusion of right external carotid artery

    with bioactive intraluminal device,

    percutaneous endoscopic approach.

    03LM4DZ.................. Occlusion of right external carotid artery

    with intraluminal device, percutaneous

    endoscopic approach.

    03LN3BZ.................. Occlusion of left external carotid artery

    with bioactive intraluminal device,

    percutaneous approach.

    03LN3DZ.................. Occlusion of left external carotid artery

    with intraluminal device, percutaneous

    approach.

    03LN4BZ.................. Occlusion of left external carotid artery

    with bioactive intraluminal device,

    percutaneous endoscopic approach.

    03LN4DZ.................. Occlusion of left external carotid artery

    with intraluminal device, percutaneous

    endoscopic approach.

    03LP3BZ.................. Occlusion of right vertebral artery with

    bioactive intraluminal device, percutaneous

    approach.

    03LP3DZ.................. Occlusion of right vertebral artery with

    intraluminal device, percutaneous approach.

    03LP4BZ.................. Occlusion of right vertebral artery with

    bioactive intraluminal device, percutaneous

    endoscopic approach.

    03LP4DZ.................. Occlusion of right vertebral artery with

    intraluminal device, percutaneous endoscopic

    approach.

    03LQ3BZ.................. Occlusion of left vertebral artery with

    bioactive intraluminal device, percutaneous

    approach.

    03LQ3DZ.................. Occlusion of left vertebral artery with

    intraluminal device, percutaneous approach.

    03LQ4BZ.................. Occlusion of left vertebral artery with

    bioactive intraluminal device, percutaneous

    endoscopic approach.

    03LQ4DZ.................. Occlusion of left vertebral artery with

    intraluminal device, percutaneous endoscopic

    approach.

    03LR3DZ.................. Occlusion of face artery with intraluminal

    device, percutaneous approach.

    03LR4DZ.................. Occlusion of face artery with intraluminal

    device, percutaneous endoscopic approach.

    03LS3DZ.................. Occlusion of right temporal artery with

    intraluminal device, percutaneous approach.

    03LS4DZ.................. Occlusion of right temporal artery with

    intraluminal device, percutaneous endoscopic

    approach.

    03LT3DZ.................. Occlusion of left temporal artery with

    intraluminal device, percutaneous approach.

    03LT4DZ.................. Occlusion of left temporal artery with

    intraluminal device, percutaneous endoscopic

    approach.

    03VG3BZ.................. Restriction of intracranial artery with

    bioactive intraluminal device, percutaneous

    approach.

    03VG3DZ.................. Restriction of intracranial artery with

    intraluminal device, percutaneous approach.

    03VG4BZ.................. Restriction of intracranial artery with

    bioactive intraluminal device, percutaneous

    endoscopic approach.

    03VG4DZ.................. Restriction of intracranial artery with

    intraluminal device, percutaneous endoscopic

    approach.

    03VH3BZ.................. Restriction of right common carotid artery

    with bioactive intraluminal device,

    percutaneous approach.

    Page 49360

    03VH3DZ.................. Restriction of right common carotid artery

    with intraluminal device, percutaneous

    approach.

    03VH4BZ.................. Restriction of right common carotid artery

    with bioactive intraluminal device,

    percutaneous endoscopic approach.

    03VH4DZ.................. Restriction of right common carotid artery

    with intraluminal device, percutaneous

    endoscopic approach.

    03VJ3BZ.................. Restriction of left common carotid artery

    with bioactive intraluminal device,

    percutaneous approach.

    03VJ3DZ.................. Restriction of left common carotid artery

    with intraluminal device, percutaneous

    approach.

    03VJ4BZ.................. Restriction of left common carotid artery

    with bioactive intraluminal device,

    percutaneous endoscopic approach.

    03VJ4DZ.................. Restriction of left common carotid artery

    with intraluminal device, percutaneous

    endoscopic approach.

    03VK3BZ.................. Restriction of right internal carotid artery

    with bioactive intraluminal device,

    percutaneous approach.

    03VK3DZ.................. Restriction of right internal carotid artery

    with intraluminal device, percutaneous

    approach.

    03VK4BZ.................. Restriction of right internal carotid artery

    with bioactive intraluminal device,

    percutaneous endoscopic approach.

    03VK4DZ.................. Restriction of right internal carotid artery

    with intraluminal device, percutaneous

    endoscopic approach.

    03VL3BZ.................. Restriction of left internal carotid artery

    with bioactive intraluminal device,

    percutaneous approach.

    03VL3DZ.................. Restriction of left internal carotid artery

    with intraluminal device, percutaneous

    approach.

    03VL4BZ.................. Restriction of left internal carotid artery

    with bioactive intraluminal device,

    percutaneous endoscopic approach.

    03VL4DZ.................. Restriction of left internal carotid artery

    with intraluminal device, percutaneous

    endoscopic approach.

    03VM3BZ.................. Restriction of right external carotid artery

    with bioactive intraluminal device,

    percutaneous approach.

    03VM3DZ.................. Restriction of right external carotid artery

    with intraluminal device, percutaneous

    approach.

    03VM4BZ.................. Restriction of right external carotid artery

    with bioactive intraluminal device,

    percutaneous endoscopic approach.

    03VM4DZ.................. Restriction of right external carotid artery

    with intraluminal device, percutaneous

    endoscopic approach.

    03VN3BZ.................. Restriction of left external carotid artery

    with bioactive intraluminal device,

    percutaneous approach.

    03VN3DZ.................. Restriction of left external carotid artery

    with intraluminal device, percutaneous

    approach.

    03VN4BZ.................. Restriction of left external carotid artery

    with bioactive intraluminal device,

    percutaneous endoscopic approach.

    03VN4DZ.................. Restriction of left external carotid artery

    with intraluminal device, percutaneous

    endoscopic approach.

    03VP3BZ.................. Restriction of right vertebral artery with

    bioactive intraluminal device, percutaneous

    approach.

    03VP3DZ.................. Restriction of right vertebral artery with

    intraluminal device, percutaneous approach.

    03VP4BZ.................. Restriction of right vertebral artery with

    bioactive intraluminal device, percutaneous

    endoscopic approach.

    03VP4DZ.................. Restriction of right vertebral artery with

    intraluminal device, percutaneous endoscopic

    approach.

    03VQ3BZ.................. Restriction of left vertebral artery with

    bioactive intraluminal device, percutaneous

    approach.

    03VQ3DZ.................. Restriction of left vertebral artery with

    intraluminal device, percutaneous approach.

    03VQ4BZ.................. Restriction of left vertebral artery with

    bioactive intraluminal device, percutaneous

    endoscopic approach.

    03VQ4DZ.................. Restriction of left vertebral artery with

    intraluminal device, percutaneous endoscopic

    approach.

    03VR3DZ.................. Restriction of face artery with intraluminal

    device, percutaneous approach.

    03VR4DZ.................. Restriction of face artery with intraluminal

    device, percutaneous endoscopic approach.

    03VS3DZ.................. Restriction of right temporal artery with

    intraluminal device, percutaneous approach.

    03VS4DZ.................. Restriction of right temporal artery with

    intraluminal device, percutaneous endoscopic

    approach.

    03VT3DZ.................. Restriction of left temporal artery with

    intraluminal device, percutaneous approach.

    03VT4DZ.................. Restriction of left temporal artery with

    intraluminal device, percutaneous endoscopic

    approach.

    03VU3DZ.................. Restriction of right thyroid artery with

    intraluminal device, percutaneous approach.

    03VU4DZ.................. Restriction of right thyroid artery with

    intraluminal device, percutaneous endoscopic

    approach.

    03VV3DZ.................. Restriction of left thyroid artery with

    intraluminal device, percutaneous approach.

    03VV4DZ.................. Restriction of left thyroid artery with

    intraluminal device, percutaneous endoscopic

    approach.

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

    For this request, as discussed in the FY 2016 IPPS/LTCH PPS proposed rule, we first examined claims data for all intracranial vascular procedure cases with a principal diagnosis of hemorrhage reported in MS-DRGs 020, 021, and 022 in the December 2014 update of the FY 2014 MedPAR file. The table below shows our findings. We found a total of 1,755 cases with an average length of stay ranging from 8.28 days to 16.84 days and average costs ranging from $36,998 to $71,665 in MS-DRGs 020, 021, and 022.

    Intracranial Vascular Procedures With Principal Diagnosis of Hemorrhage

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

    Number of Average length

    MS-DRG cases of stay Average costs

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

    MS-DRG 020 (with MCC)--All cases................................ 1,285 16.84 $71,655

    MS-DRG 021 (with CC)--All cases................................. 372 13.82 52,143

    MS-DRG 022 (without CC/MCC)--All cases.......................... 98 8.28 36,998

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

    Next, we examined claims data on the first part of the request, which was to create a new MS-DRG for endovascular intracranial embolization procedure cases with a principal diagnosis of hemorrhage that are currently assigned to MS-DRGs 020, 021, and 022. Our findings for the first part of this multi-part request are shown in the table below.

    Page 49361

    Endovascular Intracranial Embolization Procedures With Principal Diagnosis of Hemorrhage

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

    Average length

    MS-DRG Number of cases of stay Average costs

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

    Requested new combined MS-DRG................................ 1,275 15.6 $67,831

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

    The requestor suggested that this new requested base MS-DRG would not be subdivided by severity levels. Using the requested code logic, cases with a principal diagnosis of hemorrhage and procedure codes 39.72 (Endovascular (total) embolization or occlusion of head and neck vessels), 39.75 (Endovascular embolization or occlusion of vessel(s) of head or neck using bare coils), and 39.76 (Endovascular embolization or occlusion of vessel(s) of head or neck using bioactive coils) would be moved out of MS-DRGs 020, 021, and 022 and into a single new MS-DRG with no severity levels.

    As can be seen in the table above, the average costs for the new requested combined MS-DRG would be $67,831. The average costs for current MS-DRGs 020, 021, and 022 were $71,655, $52,143, and $36,998, respectively. Based on these findings, if we established this requested new MS-DRG, payments for those cases at the highest severity level (MS-

    DRG 020, which had average costs of $71,655) would be reduced.

    In the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24351 through 24356), we stated that we believe that maintaining the current MS-DRG assignment for these types of procedures is appropriate. Our clinical advisors stated that the current grouping of procedures within MS-DRGs 020, 021, and 022 reflects patients who are unique in terms of utilization and complexity based on the three severity levels, which are specifically designed to capture clinical differences in these patients, and these factors support maintaining the current structure. Therefore, we did not propose to move cases with a principal diagnosis of hemorrhage and procedure codes 39.72, 39.75, and 39.76 out of MS-

    DRGs 020, 021, and 022 and create a new base MS-DRG. We invited public comments on this proposal.

    As discussed earlier in this section, the requestor also recommended the creation of a new set of MS-DRGs for endovascular intracranial embolization procedures without a principal diagnosis of hemorrhage with MCC, with CC, and without CC/MCC. For these requested new MS-DRGs, the requestor suggested assignment of endovascular embolization procedures as well as certain other percutaneous and endovascular procedures. The complete list of endovascular intracranial embolization procedures developed by the requestor is as follows:

    00.62 (Percutaneous angioplasty of intracranial vessel);

    39.72 (Endovascular (total) embolization or occlusion of head and neck vessels);

    39.74 (Endovascular removal of obstruction from head and neck vessel(s));

    39.75 (Endovascular embolization or occlusion of vessel(s) of head or neck using bare coils);

    39.76 (Endovascular embolization or occlusion of vessel(s) of head or neck using bioactive coils); and

    39.79 (Other endovascular procedures on other vessels)

    The following table shows our findings from examination of claims data on endovascular intracranial procedures without a principal diagnosis of hemorrhage reported in MS-DRGs 023 through 027 from the December 2014 update of the FY 2014 MedPAR file.

    Endovascular Intracranial Procedures Without Principal Diagnosis of Hemorrhage

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

    Number of Average length

    MS-DRG cases of stay Average costs

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

    MS-DRG 023--All cases........................................... 5,615 10.96 $37,784

    MS-DRG 023--Cases with endovascular intracranial procedure 1,510 8.88 39,666

    without diagnosis of hemorrhage................................

    MS-DRG 024--All cases........................................... 1,848 5.93 26,195

    MS-DRG 024--Cases with endovascular intracranial procedure 867 5.80 27,975

    without diagnosis of hemorrhage................................

    MS-DRG 025--All cases........................................... 16,949 9.35 29,970

    MS-DRG 025--Cases with endovascular intracranial procedure 650 8.52 44,082

    without diagnosis of hemorrhage................................

    MS-DRG 026--All cases........................................... 8,075 6.09 21,414

    MS-DRG 026--Cases with endovascular intracranial procedure 778 3.07 26,594

    without diagnosis of hemorrhage................................

    MS-DRG 027--All cases........................................... 9,883 3.15 16,613

    MS-DRG 027--Cases with endovascular intracranial procedure 1,793 1.66 22,244

    without diagnosis of hemorrhage................................

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

    As can be seen from this table, if we created a new set of MS-DRGs recommended by the requester, most of the cases would have to be moved out of MS-DRGs 023 and 027. The 1,510 cases that would have to be moved out of MS-DRG 023 have average costs of $39,666 compared to average costs of $37,784 for all cases in MS-DRG 023. The average costs for these cases are not significantly different from the average costs for all cases in MS-DRG 023. The average length of stay for the cases with endovascular intracranial procedure without a diagnosis of hemorrhage in MS-DRG 023 is 8.88 compared to 10.96 days for all cases in MS-DRG 023. In the proposed rule, we stated that we believe that these data support the current MS-DRG assignment for MS-DRG 023. The 1,793 cases that would have to be moved out of MS-DRG 027 have average costs of $22,244 compared to the average costs of $16,613 for all cases in MS-

    DRG 027. While the average costs for these cases are higher than for all cases in MS-DRG 027, one would

    Page 49362

    expect some procedures within an MS-DRG to have higher average costs and other procedures to have lower average costs than the overall average costs. Cases within the MS-DRGs describing endovascular intracranial procedures are grouped together based on similar clinical and resource criteria. Some cases will have average costs that are higher than the overall average costs for cases in the MS-DRG, while other cases will have lower average costs. These differences in average costs are found within all MS-DRGs. The average length of stay of MS-

    DRG 027 cases with endovascular intracranial procedure without a diagnosis of hemorrhage is 1.66 days as compared to 3.15 days for all cases in MS-DRG 027. Therefore, while the average costs are higher for the cases with endovascular intracranial procedure without a diagnosis of hemorrhage than for all cases in MS-DRG 027, the length of stay is shorter.

    The 867 cases that would have to be moved out of MS-DRG 024 have average costs of $27,975 compared to average costs for all cases in MS-

    DRG 024 of $26,195. The average costs for these cases are not significantly different than the average costs for all cases in MS-DRG 024. The average length of stay for the 867 cases that would have to be moved out of MS-DRG 024 is 5.80 compared to 5.93 for all cases in MS-

    DRG 024. Therefore, the lengths of stay for the cases also are quite similar in MS-DRG 024. In the FY 2016 IPPS/LTCH PPS proposed rule, we stated that we determined that these data findings support maintaining the current MS-DRG assignment of these procedures in MS-DRG 024.

    MS-DRGs 025 and 026 show the smallest number of cases that would have to be moved to the requested new MS-DRGs, but these cases have larger differences in average costs. The average costs of cases that would have to be moved out of MS-DRG 025 are $44,082 compared to $29,970 for all cases in MS-DRG 025. The average length of stay for the MS-DRG 025 cases with endovascular intracranial procedure without a diagnosis of hemorrhage is 8.52 days as compared to 9.35 days for all cases in MS-DRG 025. Therefore, the lengths of stay are similar for cases in MS-DRG 025. The average costs of cases that would have to be moved out of MS-DRG 026 are $26,594 compared to $21,414 for all cases. The average length of stay for cases that would have to be moved out of MS-DRG 026 is 3.07 days compared to 6.09 days for all cases in MS-DRG 026, or almost half as long as for all cases in MS-DRG 026. As stated earlier, the average costs for cases that would be moved out of MS-DRGs 023, 024, 025, 026, and 027 under this request are higher than the average costs for all cases in these MS-DRGs, with most of the cases coming out of MS-DRGs 023 and 027. The average costs for these particular cases in MS-DRG 023 are not significantly different from the average costs for all cases in MS-DRG 023. In addition, while the average costs are higher for the cases with an endovascular intracranial procedure without a diagnosis of hemorrhage than for all cases in MS-DRG 027, the length of stay is shorter. We determined that the overall data do not support making the requested MS-DRG updates to MS-DRGs 023, 024, 025, 026, and 027 and creating three new MS-DRGs. Therefore, we did not propose to make changes to the current structure for MS-DRGs 023 through 027.

    In summary, our clinical advisors reviewed each aspect of this multi-part request and advised us that the endovascular embolization procedures are appropriately assigned to MS-DRGs 020 through 027. They did not support removing the procedures (procedure codes 39.72, 39.75, and 39.76) from MS-DRGs 020, 021, and 022 and creating a single MS-DRG for endovascular intracranial embolization procedures with a principal diagnosis of hemorrhage with no severity levels. Our clinical advisors stated that the current MS-DRG grouping of three severity levels captures differences in clinical severity, average costs, and length of stay for these patients appropriately. Our clinical advisors also recommended maintaining the current MS-DRG assignments for endovascular embolization and other percutaneous and endovascular procedures within MS-DRGs 023 through 027. They stated that these procedures are all clinically similar to others in these MS-DRGs. In addition, they stated that the surgical techniques are all designed to correct the same clinical problem, and they advised against moving a select number of those procedures out of MS-DRGs 023 through 027.

    Based on the findings from our data analysis and the recommendations from our clinical advisors, in the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24356), we did not propose to create the four new MS-DRGs for endovascular intracranial embolization and other endovascular procedures recommended by the requestor. We proposed to maintain the current MS-DRG structure for MS-DRGs 020 through 027.

    We invited public comments on these two proposals.

    Comment: A number of commenters supported the proposal to maintain the current MS-DRG structure for MS-DRGs 020 through 027 and not to create four new MS-DRGs for endovascular intracranial embolization and other endovascular procedures. The commenters stated that the proposal was reasonable, given the data and information provided.

    One commenter disagreed with the proposal. The commenter stated that the data demonstrate that the cost of endovascular coil cases consistently exceeds the overall average cost of all cases within each of the MS-DRGs to which these procedures are currently assigned. Moreover, the commenter believed that it was inappropriate to minimize the clinical complexity of these procedures compared to other procedures in the current MS-DRGs.

    Response: We appreciate the commenters' support for our proposal to maintain the current MS-DRG structure for MS-DRGs 020 through 027 and not to create four new MS-DRGs for endovascular intracranial embolization and other endovascular procedures. In response to the commenter who disagreed with the proposal, as stated earlier in this section, while we recognize that the average costs of these cases are higher than the average costs of all cases in MS-DRGs 023 through 027, one would expect some procedures within an MS-DRG to have higher average costs and other procedures to have lower average costs than the overall average costs. Cases within the MS-DRGs describing endovascular intracranial procedures are grouped together based on similar clinical and resource criteria. Some cases will have average costs that are higher than the overall average costs for cases in the MS-DRG, while other cases will have lower average costs. Our clinical advisors recommended maintaining the current MS-DRG assignments for endovascular embolization and other percutaneous and endovascular procedures within MS-DRGs 023 through 027. They continue to believe that these procedures are all clinically similar to others in these MS-DRGs and that the surgical techniques are all designed to correct the same clinical problem, and continue to advise against moving a select number of those procedures out of MS-DRGs 020 through 027. Our clinical advisors stated that the endovascular intracranial embolizations and other endovascular procedures address the same clinical problems as other procedures assigned to MS-DRGs 020 through 027. Therefore, the cases in MS-DRGs 020 through 027 are clinically similar.

    After consideration of the public comments we received, we are finalizing our proposal to maintain the

    Page 49363

    current MS-DRG structure for MS-DRGs 020 through 027 and not to create four new MS-DRGs for endovascular intracranial embolization and other endovascular procedures.

    3. MDC 5 (Diseases and Disorders of the Circulatory System)

  189. Adding Severity Levels to MS-DRGs 245 Through 251

    During the comment period for the FY 2015 IPPS/LTCH PPS proposed rule, we received a comment that recommended establishing severity levels for MS-DRG 245 (AICD Generator Procedures) and including additional severity levels for MS-DRG 246 (Percutaneous Cardiovascular Procedure with Drug-Eluting Stent with MCC or 4+ Vessels/Stents); MS-

    DRG 247 (Percutaneous Cardiovascular Procedure with Drug-Eluting Stent without MCC); MS-DRG 248 (Percutaneous Cardiovascular Procedure with Non-Drug-Eluting Stent with MCC or 4+ Vessels/Stents); MS-DRG 249 (Percutaneous Cardiovascular Procedure with Non-Drug-Eluting Stent without MCC); MS-DRG 250 (Percutaneous Cardiovascular Procedure without Coronary Artery Stent with MCC); and MS-DRG 251 (Percutaneous Cardiovascular Procedure without Coronary Artery Stent without MCC).

    We considered this public comment to be outside of the scope of the FY 2015 IPPS/LTCH PPS proposed rule. Therefore, we did not address this comment in the FY 2015 IPPS/LTCH PPS final rule. However, we indicated that we would consider the public comment for possible proposals in future rulemaking as part of our annual review process.

    For the FY 2016 IPPS/LTCH PPS proposed rule, we received a separate, but related, request involving most of these same MS-DRGs. Therefore, for the FY 2016 IPPS/LTCH PPS proposed rule, we conducted a simultaneous analysis of claims data to address both the FY 2015 public comment request and the related FY 2016 request. We discuss both of these requests below.

  190. Percutaneous Intracardiac Procedures

    We received a request to remove the cardiac ablation and other specified cardiovascular procedures from the following MS-DRGs, and to create new MS-DRGs to classify these procedures:

    MS-DRG 246 (Percutaneous Cardiovascular Procedure with Drug-Eluting Stent with MCC or 4+ Vessels/Stents);

    MS-DRG 247 (Percutaneous Cardiovascular Procedure with Drug-Eluting Stent without MCC);

    MS-DRG 248 (Percutaneous Cardiovascular Procedure with Non-Drug-Eluting Stent with MCC or 4+ Vessels/Stents);

    MS-DRG 249 (Percutaneous Cardiovascular Procedure with Non-Drug-Eluting Stent without MCC);

    MS-DRG 250 (Percutaneous Cardiovascular Procedure without Coronary Artery Stent with MCC); and

    MS-DRG 251 (Percutaneous Cardiovascular Procedure without Coronary Artery Stent without MCC).

    The commenter stated that, historically, the MS-DRGs listed above appropriately reflected the differential cost of percutaneous transluminal coronary angioplasty (PTCA) procedures with and without stents. The commenter noted that PTCA procedures with drug eluting stents were previously paid the highest, followed by PTCA procedures with bare metal stents and PTCA procedures with no stents, respectively. However, the commenter believed that, in recent years, the opposite has begun to occur and cases reporting a PTCA procedure without a stent are being paid more than cases reporting a PTCA procedure with a stent. The commenter further noted that cardiac ablation procedures and PTCA procedures without stents are currently assigned to the same MS-DRGs, notwithstanding that the procedures have different clinical objectives and patient diagnoses. The commenter indicated that cardiac ablation procedures are performed on patients with multiple distinct cardiac arrhythmias to alter electrical conduction systems of the heart, and PTCA procedures are performed on patients with coronary atherosclerosis to open blocked coronary arteries. The commenter also noted that cardiac ablation procedures are performed in the heart chambers by cardiac electrophysiologists, require significantly more resources, and require longer periods of time to complete. Conversely, PTCA procedures are performed in the coronary vessels by interventional cardiologists, require the use of less equipment, and require a shorter period of time to complete. Therefore, the commenter suggested that CMS create new MS-DRGs for percutaneous intracardiac procedures to help improve clinical homogeneity by differentiating percutaneous intracardiac procedures (performed within the heart chambers) from percutaneous intracoronary procedures (performed within the coronary vessels). The commenter further believed that creating new MS-DRGs for these procedures would also better reflect the resource cost of specialized equipment used for more complex structures of electrical conduction systems when performing cardiac ablation procedures.

    The following ICD-9-CM procedure codes identify and describe the cardiac ablation procedures and the other percutaneous intracardiac procedures that are currently classified under MS-DRGs 246 through 251 and that the commenter recommended that CMS assign to the newly created MS-DRGs:

    35.52 (Repair of atrial septal defect with prosthesis, closed technique);

    35.96 (Percutaneous balloon valvuloplasty);

    35.97 (Percutaneous mitral valve repair with implant);

    37.26 (Catheter based invasive electrophysiologic testing);

    37.27 (Cardiac mapping);

    37.34 (Excision or destruction of other lesion or tissue of heart, endovascular approach);

    37.36 (Excision, destruction, or exclusion of left atrial appendage (LAA)); and

    37.90 (Insertion of left atrial appendage device).

    There are a number of ICD-10-PCS code translations that provide more detailed and specific information for each of the ICD-9-CM procedure codes listed above that also are currently classified under MS-DRGs 246 through 251 based on the GROUPER Version 32 ICD-10 MS-DRGs. The comparable ICD-10-PCS code translations for ICD-9-CM procedure code 35.52 are shown in the following table.

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 35.52

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

    ICD-10-PCS Code Code description

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

    02U53JZ.................. Supplement atrial septum with synthetic

    substitute, percutaneous approach.

    02U54JZ.................. Supplement atrial septum with synthetic

    substitute, percutaneous endoscopic

    approach.

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

    Page 49364

    The comparable ICD-10-PCS code translations for ICD-9-CM procedure code 35.96 are shown in the following table.

    ICD-10-PCS Translations for ICD-9-CM Procedure Code 35.96

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

    ICD-10-PCS Code Code description

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

    027F34Z.................. Dilation of aortic valve with drug-eluting

    intraluminal device, percutaneous approach.

    027F3DZ.................. Dilation of aortic valve with intraluminal

    device, percutaneous approach.

    027F3ZZ.................. Dilation of aortic valve, percutaneous

    approach.

    027F44Z.................. Dilation of aortic valve with drug-eluting

    intraluminal device, percutaneous endoscopic

    approach.

    027F4DZ.................. Dilation of aortic valve with intraluminal

    device, percutaneous endoscopic approach.

    027F4ZZ.................. Dilation of aortic valve, percutaneous

    endoscopic approach.

    027G34Z.................. Dilation of mitral valve with drug-eluting

    intraluminal device, percutaneous approach.

    027G3DZ.................. Dilation of mitral valve with intraluminal

    device, percutaneous approach.

    027G3ZZ.................. Dilation of mitral valve, percutaneous

    approach.

    027G44Z.................. Dilation of mitral valve with drug-eluting

    intraluminal device, percutaneous endoscopic

    approach.

    027G4DZ.................. Dilation of mitral valve with intraluminal

    device, percutaneous endoscopic approach.

    027G4ZZ.................. Dilation of mitral valve, percutaneous

    endoscopic approach.

    027H34Z.................. Dilation of pulmonary valve with drug-eluting

    intraluminal device, percutaneous approach.

    027H3DZ.................. Dilation of pulmonary valve with intraluminal

    device, percutaneous approach.

    027H3ZZ.................. Dilation of pulmonary valve, percutaneous

    approach.

    027H44Z.................. Dilation of pulmonary valve with drug-eluting

    intraluminal device, percutaneous endoscopic

    approach.

    027H4DZ.................. Dilation of pulmonary valve with intraluminal

    device, percutaneous endoscopic approach.

    027H4ZZ.................. Dilation of pulmonary valve, percutaneous

    endoscopic approach.

    027J34Z.................. Dilation of tricuspid valve with drug-eluting

    intraluminal device, percutaneous approach.

    027J3DZ.................. Dilation of tricuspid valve with intraluminal

    device, percutaneous approach.

    027J3ZZ.................. Dilation of tricuspid valve, percutaneous

    approach.

    027J44Z.................. Dilation of tricuspid valve with drug-eluting

    intraluminal device, percutaneous endoscopic

    approach.

    027J4DZ.................. Dilation of tricuspid valve with intraluminal

    device, percutaneous endoscopic approach.

    027J4ZZ.................. Dilation of tricuspid valve, percutaneous

    endoscopic approach.

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

    The ICD-10-PCS code translation for ICD-9-CM procedure code 35.97 is 02UG3JZ (Supplement mitral valve with synthetic substitute, percutaneous approach).

    The ICD-10-PCS code translation for ICD-9-CM procedure code 37.26 is 4A023FZ (Measurement of cardiac rhythm, percutaneous approach).

    The comparable ICD-10-PCS code translations for ICD-9-CM procedure code 37.27 are shown in the following table.

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 37.27

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

    ICD-10-PCS Code Code description

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

    02K83ZZ.................. Map conduction mechanism, percutaneous

    approach.

    02K84ZZ.................. Map conduction mechanism, percutaneous

    endoscopic approach.

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

    The comparable ICD-10-PCS code translations for ICD-9-CM procedure code 37.34 are shown in the following table:

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 37.34

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

    ICD-10-PCS Code Code description

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

    02553ZZ.................. Destruction of atrial septum, percutaneous

    approach.

    02563ZZ.................. Destruction of right atrium, percutaneous

    approach.

    02573ZZ.................. Destruction of left atrium, percutaneous

    approach.

    02583ZZ.................. Destruction of conduction mechanism,

    percutaneous approach.

    02593ZZ.................. Destruction of chordae tendineae,

    percutaneous approach.

    025F3ZZ.................. Destruction of aortic valve, percutaneous

    approach.

    025G3ZZ.................. Destruction of mitral valve, percutaneous

    approach.

    025H3ZZ.................. Destruction of pulmonary valve, percutaneous

    approach.

    025J3ZZ.................. Destruction of tricuspid valve, percutaneous

    approach.

    025K3ZZ.................. Destruction of right ventricle, percutaneous

    approach.

    025L3ZZ.................. Destruction of left ventricle, percutaneous

    approach.

    025M3ZZ.................. Destruction of ventricular septum,

    percutaneous approach.

    02B53ZZ.................. Excision of atrial septum, percutaneous

    approach.

    02B63ZZ.................. Excision of right atrium, percutaneous

    approach.

    02B73ZZ.................. Excision of left atrium, percutaneous

    approach.

    02B83ZZ.................. Excision of conduction mechanism,

    percutaneous approach.

    02B93ZZ.................. Excision of chordae tendineae, percutaneous

    approach.

    Page 49365

    02BF3ZZ.................. Excision of aortic valve, percutaneous

    approach.

    02BG3ZZ.................. Excision of mitral valve, percutaneous

    approach.

    02BH3ZZ.................. Excision of pulmonary valve, percutaneous

    approach.

    02BJ3ZZ.................. Excision of tricuspid valve, percutaneous

    approach.

    02BM3ZZ.................. Excision of ventricular septum, percutaneous

    approach.

    02T83ZZ.................. Resection of conduction mechanism,

    percutaneous approach.

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

    The comparable ICD-10-PCS code translations for ICD-9-CM procedure code 37.36 are shown in the following table:

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 37.36

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

    ICD-10-PCS Code Code description

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

    02573ZK.................. Destruction of left atrial appendage,

    percutaneous approach.

    02574ZK.................. Destruction of left atrial appendage,

    percutaneous endoscopic approach.

    02B73ZK.................. Excision of left atrial appendage,

    percutaneous approach.

    02B74ZK.................. Excision of left atrial appendage,

    percutaneous endoscopic approach.

    02L73ZK.................. Occlusion of left atrial appendage,

    percutaneous approach.

    02L74ZK.................. Occlusion of left atrial appendage,

    percutaneous endoscopic approach.

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

    The comparable ICD-10-PCS code translations for ICD-9-CM procedure code 37.90 are shown in the following table:

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 37.90

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

    ICD-10-PCS Code Code description

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

    02L73CK.................. Occlusion of left atrial appendage with

    extraluminal device, percutaneous approach.

    02L73DK.................. Occlusion of left atrial appendage with

    intraluminal device, percutaneous approach.

    02L74CK.................. Occlusion of left atrial appendage with

    extraluminal device, percutaneous endoscopic

    approach.

    02L74DK.................. Occlusion of left atrial appendage with

    intraluminal device, percutaneous endoscopic

    approach.

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

    The ICD-10-PCS code translations listed above, along with their respective MS-DRG assignments, can be found in the ICD-10 MS-DRGs Version 32 Definitions Manual posted on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-Project.html.

    As mentioned earlier, we received a separate, but related, request to add severity levels to MS-DRGs 246 through 251. We address this request at the end of this section.

    To address the first of these separate, but related, requests, we reviewed claims data for MS-DRGs 246 through 251 from the December 2014 update of the FY 2014 MedPAR file. Our findings are shown in the following table:

    Percutaneous Cardiovascular MS-DRGs With and Without Stents

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

    Number of Average length

    MS-DRG cases of stay Average costs

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

    MS-DRG 246--All cases........................................... 30,617 5.52 $23,855

    MS-DRG 246--Cases with procedure codes 35.52, 35.96, 35.97, 244 9.69 34.099

    37.26, 37.27, 37.34, 37.36, and 37.90..........................

    MS-DRG 247--All cases........................................... 79,639 2.69 15,671

    MS-DRG 247--Cases with procedure codes 35.52, 35.96, 35.97, 260 5.20 25,797

    37.26, 37.27, 37.34, 37.36, and 37.90..........................

    MS-DRG 248--All cases........................................... 9,310 6.37 22,504

    MS-DRG 248--Cases with procedure codes 35.52, 35.96, 35.97, 125 10.76 33,521

    37.26, 37.27, 37.34, 37.36, and 37.90..........................

    MS-DRG 249--All cases........................................... 16,273 3.08 14,066

    MS-DRG 249--Cases with procedure codes 35.52, 35.96, 35.97, 81 5.12 23,710

    37.26, 37.27, 37.34, 37.36, and 37.90..........................

    MS-DRG 250--All cases........................................... 9,275 7.07 22,902

    MS-DRG 250--Cases with procedure codes 35.52, 35.96, 35.97, 5,826 7.90 24,841

    37.26, 37.27, 37.34, 37.36, and 37.90..........................

    MS-DRG 251--All cases........................................... 20,945 3.25 15,757

    Page 49366

    MS-DRG 251--Cases with procedure codes 35.52, 35.96, 35.97, 14,436 3.39 17,290

    37.26, 37.27, 37.34, 37.36, and 37.90..........................

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

    As shown in the table above, there were a total of 30,617 cases in MS-DRG 246, with an average length of stay of 5.52 days and average costs of $23,855. For cases reporting a percutaneous intracardiac procedure in MS-DRG 246 (ICD-9-CM procedure codes 35.52, 35.96, 35.97, 37.26, 37.27, 37.34, 37.36, and 37.90), there were a total of 244 cases, with an average length of stay of 9.69 days and average costs of $34,099. For MS-DRGs 247 through 251, a similar pattern was identified; the data reflected that the average costs are higher and the average length of stay is greater for cases reporting a percutaneous intracardiac procedure in comparison to the average costs and average length of stay for all of the cases in their respective MS-DRGs.

    As reflected in the following table, a further analysis of the data showed that percutaneous intracardiac procedures represent a total of 20,972 cases in MS-DRGs 246 through 251, with a greater average length of stay (4.79 days versus 3.62 days) and higher average costs ($19,810 versus $17,532) in comparison to all of the remaining cases in MS-DRGs 246 through 251.

    Summary of Percutaneous Cardiovascular DRGs With and Without Stents

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

    Number of Average length

    MS-DRG cases of stay Average costs

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

    MS-DRGs 246 through 251--Cases with procedure codes 35.52, 20,972 4.79 $19,810

    35.96, 35.97, 37.26, 37.27, 37.34, 37.36, and 37.90............

    MS-DRGs 246 through 251--Cases without procedure codes 35.52, 145,087 3.62 17,532

    35.96, 35.97, 37.26, 37.27, 37.34, 37.36, and 37.90............

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

    We stated in the FY 2016 IPPS/LTCH PPS proposed rule that the results of these data analyses support removing procedures performed within the heart chambers using intracardiac techniques from MS-DRGs 246 through 251, and assigning these procedures to separate MS-DRGs. The results of these data analyses also supported subdividing these MS-

    DRGs using the ``with MCC'' and ``without MCC'' severity levels based on the application of the criteria established in the FY 2008 IPPS final rule (72 FR 47169), and described in section II.G.1.b. of the preamble of the proposed rule, that must be met to warrant the creation of a CC or an MCC subgroup within a base MS-DRG. Our clinical advisors also agreed that this differentiation would improve the clinical homogeneity of these MS-DRGs by separating percutaneous intracardiac procedures (performed within the heart chambers) from percutaneous intracoronary procedures (performed within the coronary vessels). In addition, we believe that creating these new MS-DRGs would better reflect the resource cost of specialized equipment used to perform more complex structures of electrical conduction systems during cardiac ablation procedures. Therefore, for FY 2016, we proposed to create two new MS-DRGs to classify percutaneous intracardiac procedures (80 FR24359). Specifically, we proposed to create MS-DRG 273, entitled ``Percutaneous Intracardiac Procedures with MCC,'' and MS-DRG 274, entitled ``Percutaneous Intracardiac Procedures without MCC,'' and to assign the procedures performed within the heart chambers using intracardiac techniques to the two proposed new MS-DRGs. We proposed that existing percutaneous intracoronary procedures with and without stents continue to be assigned to the other MS-DRGs to reflect that those procedures are performed within the coronary vessels and require fewer resources.

    The table below represents the distribution of cases, average length of stay, and average costs for these proposed two new MS-DRGs.

    Proposed New MS-DRGs for Percutaneous Intracardiac Procedures

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

    Number of Average length

    MS-DRG cases of stay Average costs

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

    Proposed MS-DRG 273 with MCC.................................... 6,195 8.03 $25,380

    Proposed MS-DRG 274 without MCC................................. 14,777 3.44 17,475

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

    We invited public comments on our proposal to create the two new MS-DRGs for percutaneous intracardiac procedures for FY 2016. In addition, we invited public comments on the ICD-10-PCS code translations that were presented earlier in this section and our proposal to assign these procedure codes to the proposed new MS-DRGs 273 and 274.

    Comment: Several commenters supported the proposal to create proposed new MS-DRG 273 and MS-DRG 274 to improve clinical homogeneity and better reflect resource costs. The commenters stated that the proposal was reasonable, given the data and information provided. The commenters also agreed with the proposed ICD-10-PCS code translations and assignment of those codes to the proposed new MS-DRGs.

    Several commenters commended CMS for conducting the analysis and continuing to make further refinements to the MS-DRGs. One commenter specifically expressed appreciation for CMS' display of cost and length of stay data in the analysis, in addition to the clinical factors that support

    Page 49367

    differentiation of intracardiac procedures from intracoronary procedures. This commenter recommended that, if the two proposed MS-

    DRGs are finalized, CMS continue to monitor them after ICD-10 implementation in an effort to mitigate potential unintended consequences. The commenter also suggested that, in the future, additional procedure codes may warrant assignment to the proposed new MS-DRGs. Another commenter stated that adopting the proposal to create the new MS-DRGs will lead to more appropriate payment.

    Response: We appreciate the commenters' support. We agree that creating these new MS-DRGs will better reflect utilization of resources and clinical cohesiveness for intracardiac procedures in comparison to intracoronary procedures, as well as provide for appropriate payment for the procedures.

    Comment: One commenter supported the proposal but also requested that CMS provide additional information on how the payment rate will be adjusted for the remaining existing MS-DRGs (246 through 251) following the creation of proposed new MS-DRGs 273 and 274.

    Response: We thank the commenter for its support. For payment rate updates to all of the MS-DRGs for FY 2016, we refer readers to Table 5 associated with this final rule (which is available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html).

    After consideration of the public comments we received, we are finalizing our proposal to create MS-DRGs 273 (Percutaneous Intracardiac Procedures with MCC) and MS-DRG 274 (Percutaneous Intracardiac Procedures without MCC) for the FY 2016 ICD-10 MS-DRGs Version 33.

    As mentioned earlier in this section, we received a similar request in response to the FY 2015 IPPS/LTCH PPS proposed rule to add severity levels to MS-DRGs 246 through 251. We considered this public comment to be outside of the scope of the FY 2015 IPPS/LTCH PPS proposed rule. Therefore, we did not address this comment in the FY 2015 IPPS/LTCH PPS final rule. However, we indicated that we would consider the public comment for possible proposals in future rulemaking as part of our annual review process. Specifically, the commenter recommended including additional severity levels for MS-DRGs 246 through 251 and establishing severity levels for MS-DRG 245 (AICD Generator Procedures).

    For our data analysis for this recommendation, we examined claims data from the December 2014 update of the FY 2014 MedPAR file to determine if including additional severity levels in MS-DRGs 246 through 251 was warranted. During our analysis, we applied the criteria established in the FY 2008 IPPS final rule (72 FR 47169), as described in section II.G.1.b. of the preamble of the proposed rule. As shown in the table below, we collapsed MS-DRGs 246 through 251 into base MS-DRGs (MS-DRGs 246, 248, and 250) by suggested severity level and applied the criteria.

    Percutaneous Cardiovascular MS-DRG With and Without Stent Procedures by Suggested Severity Level

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

    Number of Average length

    MS-DRG cases of stay Average costs

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

    Suggested MS-DRG 246 with MCC................................... 30,617 5.52 $23,855

    Suggested MS-DRG 246 with CC.................................... 45,313 2.96 16,233

    Suggested MS-DRG 246 without CC/MCC............................. 34,326 2.33 14,928

    Suggested MS-DRG 248 with MCC................................... 9,310 6.37 22,504

    Suggested MS-DRG 248 with CC.................................... 9,510 3.49 14,798

    Suggested MS-DRG 248 without CC/MCC............................. 6,763 2.51 13,037

    Suggested MS-DRG 250 with MCC................................... 9,275 7.07 22,903

    Suggested MS-DRG 250 with CC.................................... 11,653 3.80 16,113

    Suggested MS-DRG 250 without CC/MCC............................. 9,292 2.56 15,310

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

    We found that the criterion that there be a $2,000 difference in average costs between subgroups was not met. Specifically, between the ``with CC'' and ``without CC/MCC'' subgroups for base MS-DRG 246, the difference in average costs was only $1,305; for base MS-DRG 248, the difference in average costs was only $1,761; and for base MS-DRG 250, the difference in average costs was only $803. The results of the data analysis of MS-DRGs 246 through 251 confirmed, and our clinical advisors agreed, that the existing 2-way severity level splits for these MS-DRGs (with MCC and without MCC) are appropriate, as displayed in the table below.

    Percutaneous Cardiovascular MS-DRGs With and Without Stents

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

    Number of Average length

    MS-DRG cases of stay Average costs

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

    MS-DRG 246--All cases........................................... 30,617 5.52 $23,855

    MS-DRG 247--All cases........................................... 79,639 2.69 15,671

    MS-DRG 248--All cases........................................... 9,310 6.37 22,504

    MS-DRG 249--All cases........................................... 16,273 3.08 14,066

    MS-DRG 250--All cases........................................... 9,275 7.07 22,903

    MS-DRG 251--All cases........................................... 20,945 3.25 15,757

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

    Therefore, we did not propose to further subdivide the severity levels for MS-DRGs 246 through 251. We invited public comments on our proposal not to create additional severity levels for MS-DRGs 246 through 251.

    Comment: Several commenters supported the proposal not to create additional severity levels for MS-DRGs 246 through 251. The commenters stated that the proposal was reasonable,

    Page 49368

    given the data and information provided.

    Response: We appreciate the commenters' support. Therefore, we are finalizing our proposal to not create additional severity levels for MS-DRGs 246-251 for the FY 2016 ICD-10 MS-DRGs Version 33.

    Using the same MedPAR claims data for FY 2014, we separately examined cases in MS-DRG 245 to determine whether to subdivide this MS-

    DRG into severity levels. As displayed in the table below, the results of the FY 2014 data analysis showed there were a total of 1,699 cases, with an average length of stay of 5.49 days and average costs of $34,287, in MS-DRG 245.

    AICD Generator Procedures

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

    Average length

    MS-DRG Number of cases of stay Average costs

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

    MS-DRG 245--All cases........................................ 1,699 5.49 $34,287

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

    We applied the five criteria established in the FY 2008 IPPS final rule (72 FR 47169), as described in section II.G.1.b. of the preamble of the proposed rule, to determine if it was appropriate to subdivide MS-DRG 245 into severity levels. The table below illustrates our findings.

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

    Number of Average length

    AICD Generator procedures by suggested severity level cases of stay Average costs

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

    Suggested MS-DRG 245 with MCC................................... 542 8.15 $40,004

    Suggested MS-DRG 245 with CC.................................... 939 4.51 $32,237

    Suggested MS-DRG 245 without CC/MCC............................. 218 3.12 $28,907

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

    Based on the analysis of the FY 2014 claims data for MS-DRG 245, the results supported creating a ``with MCC'' and a ``without MCC'' severity level split. However, our clinical advisors indicated that it would not be clinically appropriate to add severity levels based on an isolated year's data fluctuation because this could lead to a lack of stability in MS-DRG payments. We agreed with our clinical advisors and noted that we annually conduct an analysis of base MS-DRGs to evaluate if additional severity levels are warranted. This analysis includes 2 years of MedPAR claims data to specifically compare data results from 1 year to the next to avoid making determinations about whether additional severity levels are warranted based on an isolated year's data fluctuation. Generally, in past years, for our review of requests to add or establish severity levels, in our analysis of the most recent claims data, there was at least one criterion that was not met. Therefore, it was not necessary to further analyze data beyond 1 year. However, the results of our analysis of claims data in the December 2014 update of the FY 2014 MedPAR file for this particular request involving MS-DRG 245 demonstrate that all five criteria to establish subgroups were met, and, therefore, it was necessary to also examine the FY 2013 MedPAR claims data file.

    The results of our analysis from the December 2013 update of the FY 2013 claims data for MS-DRG 245 are shown in the table below.

    AICD Generator Procedures

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

    Average length

    MS-DRG Number of cases of stay Average costs

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

    MS-DRG 245--All cases........................................ 1,850 4.81 $33,272

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

    The FY 2013 claims data for MS-DRG 245 did not support creating any severity levels because the data did not meet one or more of the five required criteria for creating new severity levels. The data did not meet the requirement for a 3-way severity level split (with MCC, with CC, and without CC/MCC) or a 2-way severity level split (with MCC and without MCC) because there were not at least 500 cases in the MCC subgroup. While the data did meet this particular criterion for the 2-

    way severity level split of ``with CC/MCC'' and ``without CC/MCC'' because there were at least 500 cases in the CC subgroup, the data did not meet the criterion that there be at least a 20-percent difference in average costs between subgroups, as shown in the table below.

    AICD Generator Procedures

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

    Number of Average length

    MS-DRG by suggested severity level cases of stay Average costs

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

    MS-DRG 245 with MCC............................................. 44 7.32 $39,536

    MS-DRG 245 with CC.............................................. 1,118 4.26 $31,786

    MS-DRG 245 without CC/MCC....................................... 288 3.10 $29,383

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

    As stated previously, we believe that 2 years of data showing that the requested CC or MCC subgroup meets all five of the established criteria for creating severity levels are needed in order to support a proposal to add

    Page 49369

    severity levels for MS-DRG 245. Our clinical advisors also agreed that it would not be clinically appropriate to add severity levels based on an isolated year's data fluctuation because this could lead to a lack of stability in payments. Therefore, we did not propose to add severity levels for MS-DRG 245 for FY 2016. We invited public comments on the results of our analysis and our proposal not to create severity levels for MS-DRG 245.

    Comment: Several commenters supported the proposal not to create severity levels for MS-DRG 245. The commenters stated that the proposal was reasonable, given the data and information provided. One commenter specifically noted that it understood the rationale of CMS' proposal based on analysis of the FY 2013 and FY 2014 data fluctuation. However, the commenter recommended that a followup analysis be conducted for the FY 2017 IPPS/LTCH PPS proposed rule.

    Response: We appreciate the commenters' support. We intend to conduct a followup analysis for MS-DRG 245 in the FY 2017 IPPS/LTCH PPS proposed rule as the commenter recommended.

    After consideration of the public comments we received, we are finalizing our proposal not to create severity levels for MS-DRG 245 in FY 2016.

  191. Zilversupreg PTX Drug-Eluting Peripheral Stent (Zilversupreg PTXsupreg)

    The Zilversupreg PTX Drug-Eluting Peripheral Stent (Zilversupreg PTXsupreg) was approved for new technology add-on payments in FY 2014 (78 FR 50583 through 50585). Cases involving the Zilversupreg PTXsupreg that are eligible for new technology add-on payments are identified by ICD-9-CM procedure code 00.60 (Insertion of drug-eluting stent(s) of superficial femoral artery).

    We received a request from the manufacturer for an extension of new technology add-on payments for Zilversupreg PTXsupreg in FY 2016. In the request, the manufacturer asked CMS to consider three options for procedure code 00.60 for FY 2016. The first option was to extend the new technology add-on payment through FY 2016. The request to extend the new technology add-on payment is addressed in section II.I.3.e. of the preamble of the proposed rule and this final rule. The second option was to establish a new family of MS-DRGs for procedures involving drug-eluting stents used in the peripheral (noncoronary) vasculature. The third option was to assign all Zilversupreg PTXsupreg cases to MS-DRG 252 even if there is no MCC (which would necessitate revising the MS-DRG title to ``Other Vascular Procedures).

    ICD-10-PCS provides the following more detailed procedure codes for the insertion of drug-eluting stents of superficial femoral artery:

    047K04Z (Dilation of right femoral artery with drug-

    eluting intraluminal device, open approach);

    047K34Z (Dilation of right femoral artery with drug-

    eluting intraluminal device, percutaneous approach);

    047K44Z (Dilation of right femoral artery with drug-

    eluting intraluminal device, percutaneous endoscopic approach);

    047L04Z (Dilation of left femoral artery with drug-eluting intraluminal device, open approach);

    047L34Z (Dilation of left femoral artery with drug-eluting intraluminal device, percutaneous approach); and

    047L44Z (Dilation of left femoral artery with drug-eluting intraluminal device, percutaneous endoscopic approach).

    We examined claims data for cases involving the drug-eluting peripheral stent procedures reported in the December 2014 update of the FY 2014 MedPAR file for MS-DRGs 252, 253, and 254 (Other Vascular Procedures with MCC, with CC and without CC/MCC, respectively). The following table illustrates our findings.

    Drug-Eluting Peripheral Stent Procedures

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

    Number of Average length

    MS-DRG cases of stay Average costs

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

    MS-DRG 252--All cases........................................... 30,696 7.89 $23,935

    MS-DRG 252--Cases with procedure code 00.60..................... 133 9.08 32,623

    MS-DRG 253--All cases........................................... 34,746 5.68 19,030

    MS-DRG 253--Cases with procedure code 00.60..................... 353 4.99 25,396

    MS-DRG 254--All cases........................................... 15,394 2.99 12,629

    MS-DRG 254--Cases with procedure code 00.60..................... 115 2.62 21,461

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

    Our findings showed that there were only 601 peripheral angioplasty cases with a drug-eluting stent reported. Of the 601 peripheral angioplasty cases with a drug-eluting stent, 133 cases were in MS-DRG 252, 353 cases were in MS-DRG 253, and 115 cases were in MS-DRG 254. The average costs for the drug-eluting stent cases in MS-DRGs 252, 253, and 254 were $32,623, $25,396, and $21,461, respectively. The average costs for all cases in MS-DRGs 252, 253, and 254 were $23,935, $19,030, and $12,629, respectively. The average costs for the drug-eluting stent cases in MS-DRG 253 ($25,396) were higher than the average costs for all cases in MS-DRG 252 ($23,935). However, the average costs for the drug-eluting stent cases in MS-DRG 254 ($21,461) were lower than the average costs for all cases in MS-DRG 252 ($23,935).

    We determined that the small number of cases (601) did not provide justification to create a new set of MS-DRGs specifically for angioplasty of peripheral arteries using drug-eluting stents. In addition, the data did not support assigning all the drug-eluting stent cases to the highest severity level (MS-DRG 252), even when there is not an MCC, because the average costs for the drug-eluting stent cases in MS-DRG 254 ($21,461) were lower than the average costs for all cases in MS-DRG 252 ($23,935). The average length of stay for drug-eluting stent cases in MS-DRG 254 was 2.62 days compared to 7.89 days for all cases in MS-DRG 252. Cases are grouped together based on similar clinical and resource criteria.

    Our clinical advisors recommended making no MS-DRG updates for peripheral angioplasty cases with a drug-eluting stent and considered the current MS-DRG assignment appropriate. Our clinical advisors agreed that the small number of peripheral angioplasty cases with a drug-

    eluting stent does not support creating a new MS-DRG for this specific type of treatment. They stated that the cases are clinically similar to other cases within MS-DRGs 252, 253, and 254. Considering the data for peripheral angioplasty cases with a drug-eluting stent found reported in MS-DRGs 252, 253, and 254 and the input from our clinical advisors, in the FY 2016 IPPS/

    Page 49370

    LTCH proposed rule (80 FR 24362), we did not propose to make any MS-DRG updates for peripheral angioplasty cases with a drug-eluting stent. We proposed to maintain the current MS-DRG assignments for these cases in MS-DRGs 252, 253, and 254. We invited public comments on our proposal.

    Comment: A number of commenters supported the proposal to maintain the current MS-DRG assignments for peripheral angioplasty cases with a drug-eluting stent in MS-DRGs 252, 253, and 254. The commenters stated that the proposal was reasonable, given the data and information provided.

    One commenter, the manufacturer, expressed concern with the proposal and asked CMS to reconsider its recommendation for denying the request that all Zilversupreg PTXsupreg cases be assigned to MS-DRG 252 even if there were no MCC. The commenter stated that it is true that assignment of all drug-eluting cases to MS-DRG 252 would result in an overpayment for cases with a drug-eluting stent that currently are assigned to MS-DRG 254. However, the commenter stated that these cases represent only 19 percent of the drug-eluting stent cases, and that the overpayment of these cases would be modest because the average cost of drug-eluting stent cases in MS-DRG 254 is only $2,500 less than the average cost of all cases in MS-DRG 252. The commenter stated that there would be an underpayment for all the drug-eluting stent cases if the cases continue to be assigned to MS-DRGs 252, 253, and 254. The commenter stated that implementing its original request would allow more adequate payment to hospitals using the Zilversupreg PTXsupreg technology and thus remove a potential financial barrier to Medicare providers desiring to provide access of this technology to their patients.

    Another commenter asserted that it understood CMS' concern that the agency could be overpaying for uncomplicated cases by assigning all drug-eluting stent cases to MS-DRG 252, even if they did not have a MCC. However, the commenter stated that CMS is underpaying all drug-

    eluting stent cases by maintaining the current MS-DRG assignments for these procedures. The commenter expressed concern regarding patient access to this technology.

    Response: We appreciate the commenters' support for our proposal to maintain the current MS-DRG for drug-eluting stent cases in MS-DRGs 252, 253, and 254. Our clinical advisors have also reexamined this issue and continue to advise us that the cases reporting procedure code 00.60 are appropriately classified within MS-DRG 252, 253, or 254.

    In regard to the commenters who disagreed with our proposal, as stated earlier, the data do not support assigning all the drug-eluting stent cases to the highest severity level (MS-DRG 252), even when there is not an MCC. We note that while the average costs for MS-DRG 254 (lowest severity level) may only represent 19 percent of the drug-

    eluting stent cases as shown in the table above, the MS-DRGs are comprised of a distinct structure with respect to the types of patients within each severity level. This structure is based on an organizing principle that patients at the MCC level, the highest severity level, are those patients who are generally sicker, consume an increased utilization of resources, and require more complex services. Disregarding this structure solely for the purpose of increasing payment for patients who are not similar in terms of their severity of illness and resource utilization would be inconsistent with how the MS-

    DRGs are otherwise defined within the classification system.

    In addition, as the requester pointed out in its own comments, ``it is the nature of a MS-DRG system that there will be variations in cost between different hospitalizations that fall into the same MS-DRG or MS-DRGs--each MS-DRG will have some cases that are higher and some cases that are lower than the average costs for the entire MS-DRG.'' We believe that the higher average costs for the drug-eluting stent cases can be attributed to the cost of the device and not necessarily because the patients receiving these stents are more severely ill.

    With regard to the commenters' concerns regarding patient access to the technology with the expiration of the new technology add-on payment, we would expect that hospitals that now have experience with the technology and have observed favorable clinical outcomes for their patients would nonetheless consider the technology to be worth the investment. Accordingly, we will continue to monitor cases with the Zilversupreg PTXsupreg technology to determine if modifications are warranted to the MS-DRG structure in future rulemaking.

    After consideration of the public comments we received, we are finalizing our proposal to maintain the current structure for MS-DRG assignments for procedures involving drug-eluting stents in MS-DRG 252, 253, or 254 for FY 2016.

  192. Percutaneous Mitral Valve Repair System--Proposed Revision of ICD-10-PCS Version 32 Logic

    We received a comment which brought to our attention that the ICD-

    10 MS-DRGs Version 32 assignment for ICD-10-PCS procedure code 02UG3JZ (Supplement mitral valve with synthetic substitute, percutaneous approach) does not accurately replicate the ICD-9-CM MS-DRGs Version 32, which assigns this procedure code to the following MS-DRGs:

    MS-DRG 231 (Coronary Bypass with PTCA with MCC);

    MS-DRG 232 (Coronary Bypass with PTCA without MCC);

    MS-DRG 246 (Percutaneous Cardiovascular Procedure with Drug-Eluting Stent with MCC or 4+ Vessels/Stents);

    MS DRG 247 (Percutaneous Cardiovascular Procedure with Drug-Eluting Stent without MCC);

    MS-DRG 248 (Percutaneous Cardiovascular Procedure with Non-Drug-Eluting Stent with MCC or 4+ Vessels/Stents);

    MS DRG 249 (Percutaneous Cardiovascular Procedure with Non-Drug-Eluting Stent without MCC);

    MS-DRG 250 (Percutaneous Cardiovascular Procedure without Coronary Artery Stent with MCC); and

    MS-DRG 251 (Percutaneous Cardiovascular Procedure without Coronary Artery Stent without MCC).

    We agree with the commenter that the ICD-10 MS-DRGs logic should be consistent with the ICD-9 MS-DRGs logic; that is, the ICD-10 MS-DRGs Version 32 should replicate the ICD-9-CM MS-DRGs Version 32. Therefore, in the FY 2016 IPPS/LTCH PPS proposed rule, for the proposed FY 2016 ICD-10 MS-DRGs Version 33, we proposed to assign ICD-10-PCS procedure code 02UG3JZ to MS-DRGs 231 and 232 and MS-DRGs 246 through 251 (80 FR 24362). We invited public comments on this proposal.

    Comment: Several commenters agreed with the proposal to assign ICD-

    10-PCS procedure code 02UG3JZ to ICD-10 MS-DRGs 231 and 232 and MS-DRGs 246 through 251 to accurately replicate the ICD-9-CM MS-DRGs Version 32 logic. The commenters also noted that, as discussed in the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24356 through 24359), for the FY 2016 ICD-10 MS-DRGs Version 33, CMS proposed to create two new ICD-10 MS-DRGs which include ICD-10-PCS procedure code 02UG3JZ. The commenters recognized that, if proposed new MS-DRGs 273 and 274 (Percutaneous Intracardiac Procedures with and without MCC, respectively) were finalized for FY 2016, ICD-10-PCS procedure code 02UG3JZ would then group to those new MS-DRGs. The

    Page 49371

    commenters requested that CMS confirm the MS-DRG assignment.

    Response: We appreciate the commenters' support for our proposal to accurately replicate the assignment of ICD-10-PCS procedure code 02UG3JZ under the ICD-10 MS-DRGs. As discussed earlier in section III.G.3.a. of this final rule, we are finalizing our proposal to create ICD-10 MS-DRGs 273 and 274 (Percutaneous Intracardiac Procedures with and without MCC, respectively). After consideration of the public comments we received, we are confirming as final policy for the FY 2016 ICD-10 MS-DRGs Version 33 that ICD-10-PCS procedure code 02UG3JZ (Supplement mitral valve with synthetic substitute, percutaneous approach) is assigned to new ICD-10 MS-DRGs 273 and 274 and will continue to be assigned to MS-DRGs 231 and 232 (Coronary Bypass with PTC with MCC and without MCC, respectively).

  193. Major Cardiovascular Procedures: Zenithsupreg Fenestrated Abdominal Aortic Aneurysm (AAA) Graft

    New technology add-on payments for the Zenithsupreg Fenestrated Abdominal Aortic Aneurysm (AAA) Graft (Zenithsupreg F. Graft) will end on September 30, 2015. Cases involving the Zenithsupreg F. Graft are identified by ICD-9-CM procedure code 39.78 (Endovascular implantation of branching or fenestrated graft(s) in aorta) in MS-DRGs 237 and 238 (Major Cardiovascular Procedures with and without MCC, respectively). For additional information on the Zenithsupreg F. Graft, we refer readers to the FY 2015 IPPS/LTCH PPS final rule (79 FR 49921 through 49922).

    We received a request to reassign procedures described by ICD-9-CM procedure code 39.78 to the highest severity level in MS-DRGs 237 and 238, including in instances when there is not an MCC present, or to create a new MS-DRG that would contain all endovascular aneurysm repair procedures. We note that, in addition to ICD-9-CM procedure code 39.78, ICD-9-CM procedure code 39.71 (Endovascular implantation of other graft in abdominal aorta) also describes endovascular aneurysm repair procedures.

    There are a number of ICD-10-PCS code translations that provide more detailed and specific information for each of ICD-9-CM codes 39.71 and 39.78 that also currently group to MS-DRGs 237 and 238 in the ICD-

    10 MS-DRGs Version 32. The comparable ICD-10-PCS code translations for ICD-9-CM procedure code 39.71 and 39.78 are shown in the following tables:

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 39.71

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

    ICD-10-PCS Code Code description

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

    04U03JZ.................. Supplement abdominal aorta with synthetic

    substitute, percutaneous approach.

    04U04JZ.................. Supplement abdominal aorta with synthetic

    substitute, percutaneous endoscopic

    approach.

    04V03DZ.................. Restriction of abdominal aorta with

    intraluminal device, percutaneous approach.

    04V04DZ.................. Restriction of abdominal aorta with

    intraluminal device, percutaneous endoscopic

    approach.

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 39.78

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

    ICD-10-PCS Code Code description

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

    04V03DZ.................. Restriction of abdominal aorta with

    intraluminal device, percutaneous approach.

    04V04DZ.................. Restriction of abdominal aorta with

    intraluminal device, percutaneous endoscopic

    approach.

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

    Note: As discussed later in this section, the FY 2016 IPPS/LTCH PPS

    proposed rule listed the dilation codes ICD-10-PCS 04793DZ through

    04754DZ as possible translations for ICD-9-CM procedure code 39.78.

    For this final rule, we are only listing those codes that as

    ``standalone'' procedures are assigned to new MS-DRGs 268 and 269.

    We analyzed claims data reporting ICD-9-CM procedure code 39.78 for cases assigned to MS-DRGs 237 and 238 in the December 2014 update of the FY 2014 MedPAR file. We found a total of 18,340 cases, with an average length of stay of 9.46 days and average costs of $36,355 in MS-

    DRG 237. We found 332 cases reporting ICD-9-CM procedure code 39.78, with an average length of stay of 8.46 days and average costs of $51,397 in MS-DRG 237. For MS-DRG 238, we found a total of 32,227 cases, with an average length of stay of 3.72 days and average costs of $25,087. We found 1,927 cases reporting ICD-9-CM procedure code 39.78, with an average length of stay of 2.52 days and average costs of $31,739 in MS-DRG 238.

    Zenith Fenestrated Graft Procedures

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

    Number of Average length

    MS-DRG cases of stay Average costs

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

    MS-DRG 237--All cases........................................... 18,340 9.46 $36,355

    MS-DRG 237--Cases with procedure code 39.78..................... 332 8.46 51,397

    MS-DRG 238--All cases........................................... 32,227 3.72 25,087

    MS-DRG 238--Cases with procedure code 39.78..................... 1,927 2.52 31,739

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

    As illustrated in the table above, the results of the data analysis indicate that the average costs for cases reporting procedure code 39.78 assigned to MS-DRG 238 were higher than the average costs for all cases in MS-DRG 238 ($31,739 compared to $25,087). In addition, the average costs for the 1,927 cases reporting procedure code 39.78 assigned to MS-DRG 238 were $4,616 less than the costs of all cases assigned to MS-DRG 237. We determined that moving cases reporting procedure code 39.78 from MS-DRG 238 to MS-DRG 237 would result in overpayments. We

    Page 49372

    also noted that the average length of stay for the 1,927 cases reporting procedure code 39.78 in MS-DRG 238 was 2.52 days in comparison to the average length of stay for all cases in MS-DRG 237 of 9.46 days. Our clinical advisors did not agree with moving cases reporting procedure code 39.78 to a higher severity level (with MCC) MS-DRG.

    We believe that the higher average costs could be attributed to the cost of the device. The Zenithsupreg F. Graft is the only fenestrated graft device currently approved by the FDA. Therefore, this manufacturer is able to set its own costs in the market. We pointed out that the IPPS is not designed to pay solely for the cost of devices. More importantly, moving cases that greatly differ in their severity of illness and complexity of resources into a higher severity level MS-

    DRG, in the absence of an MCC, would conflict with the objective of the MS-DRGs, which is to maintain homogeneous subgroups that are different from one another in terms of utilization of resources, that have enough volume to be meaningful, and that improve our ability to explain variance in resource use (72 FR 47169). Therefore, we did not propose to reassign all cases reporting procedure code 39.78 from MS-DRG 238 to MS-DRG 237, as the commenter requested.

    However, we recognized that the results of the data analysis also demonstrated that the average costs for cases reporting ICD-9-CM procedure code 39.78 are higher in both MS-DRG 237 and MS-DRG 238 in comparison to all cases in each respective MS-DRG. As these higher average costs could be attributable to the cost of the device, we noted the commenter's concern that the end of the new technology add-on payment for Zenithsupreg F. Graft, effective September 30, 2015, may result in reduced payment to hospitals and potentially lead to issues involving access to care for the subset of beneficiaries who would benefit from treatment with the Zenithsupreg F. Graft. We continued to review the data to explore other alternatives as we analyzed additional claims data in response to the second part of the request from the commenter; that is, to create a new MS-DRG that would contain all endovascular aneurysm repair procedures.

    In our evaluation of the claims data in response to the request to create a new MS-DRG, we again reviewed claims data from the December 2014 update of the FY 2014 MedPAR file. We began our analysis by examining claims data for cases reporting ICD-9-CM procedure codes 39.71 and 39.78 assigned to MS-DRGs 237 and 238. Our findings are shown in the table below.

    Endovascular Abdominal Aorta Procedures

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

    Number of Average length

    MS-DRG cases of stay Average costs

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

    MS-DRG 237--All cases........................................... 18,340 9.46 $36,355

    MS-DRG 237--Cases with procedure codes 39.71 and 39.78.......... 2,425 8.34 47,363

    MS-DRG 238--All cases........................................... 32,227 3.72 25,087

    MS-DRG 238--Cases with procedure codes 39.71 and 39.78.......... 16,502 2.27 28,998

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

    As shown in the table above, the average costs for cases involving endovascular abdominal aorta aneurysm repair procedures assigned to MS-

    DRG 237 were higher than the average costs of all cases assigned to MS-

    DRGs 237. The average costs for cases reporting ICD-9-CM procedure codes 39.71 and 39.78 assigned to MS-DRG 237 were $47,363 compared to the average costs of $36,355 for all cases assigned to MS-DRG 237 and $25,087 for all cases assigned to MS-DRG 238. Similarly, the average costs for cases reporting ICD-9-CM procedure codes 39.71 and 39.78 assigned to MS-DRG 238 were higher than the average costs of all cases assigned to MS-DRG 238 ($28,998 compared to $25,087). The average length of stay for cases reporting ICD-9-CM procedure codes 39.71 and 39.78 in MS-DRGs 237 and 238 were also shorter than the average length of stay for all cases in the respective MS-DRG.

    Our clinical advisors did not support creating a new MS-DRG specifically for endovascular abdominal aortic aneurysm repair procedures only. Therefore, we reviewed other procedure codes currently assigned to MS-DRGs 237 and 238 and found that there were a number of procedures with varying resource requirements and clinical indications that could be analyzed further. We agreed with our clinical advisors that further analysis was warranted to determine how we could better recognize resource utilization, clinical complexity, and average costs by separating the more complex, more invasive, and more expensive procedures used to treat more severely ill individuals from the less complex, less invasive, and less expensive procedures currently grouped to these MS-DRGs.

    Therefore, we evaluated all of the procedures currently assigned to MS-DRGs 237 and 238. In our evaluation, we found that MS-DRGs 237 and 238 contained two distinct groups of procedures. We found a high volume of less invasive procedures, such as pericardiotomies and pulsation balloon implants, that had substantially lower costs than the more invasive procedures, such as open and endovascular repairs of the aorta with replacement grafts. We found that the more invasive procedures were primarily associated with procedures on the aorta and heart assist procedures.

    For this next phase of our analysis, the following procedure codes were designated as the more complex, more invasive procedures:

    37.41 (Implantation of prosthetic cardiac support device around the heart);

    37.49 (Other repair of heart and pericardium);

    37.55 (Removal of internal biventricular heart replacement system);

    37.64 (Removal of external heart assist system(s) or device(s));

    38.04 (Incision of vessel, aorta);

    38.14 (Endarterectomy, aorta);

    38.34 (Resection of vessel with anastomosis, aorta);

    38.44 (Resection of vessel with replacement, aorta, abdominal);

    38.64 (Other excision of vessels, aorta, abdominal);

    38.84 (Other surgical occlusion of vessels, aorta, abdominal);

    39.24 (Aorta-renal bypass);

    39.71 (Endovascular implantation of other graft in abdominal aorta); and

    39.78 (Endovascular implantation of branching or fenestrated graft(s) in aorta).

    There are a number of ICD-10-PCS code translations that provide more detailed and specific information for each of the ICD-9-CM codes listed above that also currently group to MS-DRGs 237 and 238 in the ICD-10 MS-DRGs Version 32. The comparable ICD-10-PCS code translations for these ICD-

    Page 49373

    9-CM procedure codes are shown in the following table:

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 37.41

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

    ICD-10-PCS Code Code description

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

    02UA0JZ.................. Supplement heart with synthetic substitute,

    open approach.

    02UA3JZ.................. Supplement heart with synthetic substitute,

    percutaneous approach.

    02UA4JZ.................. Supplement heart with synthetic substitute,

    percutaneous endoscopic approach.

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

    For the ICD-9-CM codes that result in greater than 50 ICD-10-PCS comparable code translations, we refer readers to Table 6P (ICD-10-PCS Code Translations for MS-DRG Changes) for this FY 2016 final rule (which is available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html). The table includes the MDC topic, the ICD-9-CM code, and the ICD-10-PCS code translations.

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 37.49

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

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

    The comparable ICD-10-PCS code translations for ICD-9-CM procedure code

    37.49 are shown in Table 6P.1a for this final rule that is available

    via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html.

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 37.55

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

    ICD-10-PCS Code Code description

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

    02PA0QZ.................. Removal of implantable heart assist system

    from heart, open approach.

    02PA3QZ.................. Removal of implantable heart assist system

    from heart, percutaneous approach.

    02PA4QZ.................. Removal of implantable heart assist system

    from heart, percutaneous endoscopic

    approach.

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 37.64

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

    ICD-10-PCS Code Code description

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

    02PA0RZ.................. Removal of external heart assist system from

    heart, open approach.

    02PA3RZ.................. Removal of external heart assist system from

    heart, percutaneous approach.

    02PA4RZ.................. Removal of external heart assist system from

    heart, percutaneous endoscopic approach.

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 38.04

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

    ICD-10-PCS Code Code description

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

    02CW0ZZ.................. Extirpation of matter from thoracic aorta,

    open approach.

    02CW3ZZ.................. Extirpation of matter from thoracic aorta,

    percutaneous approach.

    02CW4ZZ.................. Extirpation of matter from thoracic aorta,

    percutaneous endoscopic approach.

    04C00ZZ.................. Extirpation of matter from abdominal aorta,

    open approach.

    04C03ZZ.................. Extirpation of matter from abdominal aorta,

    percutaneous approach.

    04C04ZZ.................. Extirpation of matter from abdominal aorta,

    percutaneous endoscopic approach.

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 38.14

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

    ICD-10-PCS Code Code description

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

    02CW0ZZ.................. Extirpation of matter from thoracic aorta,

    open approach.

    02CW3ZZ.................. Extirpation of matter from thoracic aorta,

    percutaneous approach.

    02CW4ZZ.................. Extirpation of matter from thoracic aorta,

    percutaneous endoscopic approach.

    04C00ZZ.................. Extirpation of matter from abdominal aorta,

    open approach.

    04C03ZZ.................. Extirpation of matter from abdominal aorta,

    percutaneous approach.

    04C04ZZ.................. Extirpation of matter from abdominal aorta,

    percutaneous endoscopic approach.

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

    Page 49374

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 38.34

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

    ICD-10-PCS Code Code description

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

    02BW0ZZ.................. Excision of thoracic aorta, open approach.

    02BW4ZZ.................. Excision of thoracic aorta, percutaneous

    endoscopic approach.

    04B00ZZ.................. Excision of abdominal aorta, open approach.

    04B04ZZ.................. Excision of abdominal aorta, percutaneous

    endoscopic approach.

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 38.44

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

    ICD-10-PCS Code Code description

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

    04R007Z.................. Replacement of abdominal aorta with

    autologous tissue substitute, open approach.

    04R00JZ.................. Replacement of abdominal aorta with synthetic

    substitute, open approach.

    04R00KZ.................. Replacement of abdominal aorta with

    nonautologous tissue substitute, open

    approach.

    04R047Z.................. Replacement of abdominal aorta with

    autologous tissue substitute, percutaneous

    endoscopic approach.

    04R04JZ.................. Replacement of abdominal aorta with synthetic

    substitute, percutaneous endoscopic

    approach.

    04R04KZ.................. Replacement of abdominal aorta with

    nonautologous tissue substitute,

    percutaneous endoscopic approach.

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 38.64

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

    ICD-10-PCS Code Code description

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

    04500ZZ.................. Destruction of abdominal aorta, open

    approach.

    04503ZZ.................. Destruction of abdominal aorta, percutaneous

    approach.

    04504ZZ.................. Destruction of abdominal aorta, percutaneous

    endoscopic approach.

    04B00ZZ.................. Excision of abdominal aorta, open approach.

    04B03ZZ.................. Excision of abdominal aorta, percutaneous

    approach.

    04B04ZZ.................. Excision of abdominal aorta, percutaneous

    endoscopic approach.

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 38.84

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

    ICD-10-PCS Code Code description

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

    04L00CZ.................. Occlusion of abdominal aorta with

    extraluminal device, open approach.

    04L00DZ.................. Occlusion of abdominal aorta with

    intraluminal device, open approach.

    04L00ZZ.................. Occlusion of abdominal aorta, open approach.

    04L03CZ.................. Occlusion of abdominal aorta with

    extraluminal device, percutaneous approach.

    04L03DZ.................. Occlusion of abdominal aorta with

    intraluminal device, percutaneous approach.

    04L03ZZ.................. Occlusion of abdominal aorta, percutaneous

    approach.

    04L04CZ.................. Occlusion of abdominal aorta with

    extraluminal device, percutaneous endoscopic

    approach.

    04L04DZ.................. Occlusion of abdominal aorta with

    intraluminal device, percutaneous endoscopic

    approach.

    04L04ZZ.................. Occlusion of abdominal aorta, percutaneous

    endoscopic approach.

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 39.24

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

    ICD-10-PCS Code Code description

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

    0410093.................. Bypass abdominal aorta to right renal artery

    with autologous venous tissue, open

    approach.

    0410094.................. Bypass abdominal aorta to left renal artery

    with autologous venous tissue, open

    approach.

    0410095.................. Bypass abdominal aorta to bilateral renal

    artery with autologous venous tissue, open

    approach.

    04100A3.................. Bypass abdominal aorta to right renal artery

    with autologous arterial tissue, open

    approach.

    04100A4.................. Bypass abdominal aorta to left renal artery

    with autologous arterial tissue, open

    approach.

    04100A5.................. Bypass abdominal aorta to bilateral renal

    artery with autologous arterial tissue, open

    approach.

    04100J3.................. Bypass abdominal aorta to right renal artery

    with synthetic substitute, open approach.

    04100J4.................. Bypass abdominal aorta to left renal artery

    with synthetic substitute, open approach.

    04100J5.................. Bypass abdominal aorta to bilateral renal

    artery with synthetic substitute, open

    approach.

    04100K3.................. Bypass abdominal aorta to right renal artery

    with nonautologous tissue substitute, open

    approach.

    04100K4.................. Bypass abdominal aorta to left renal artery

    with nonautologous tissue substitute, open

    approach.

    04100K5.................. Bypass abdominal aorta to bilateral renal

    artery with nonautologous tissue substitute,

    open approach.

    04100Z3.................. Bypass abdominal aorta to right renal artery,

    open approach.

    04100Z4.................. Bypass abdominal aorta to left renal artery,

    open approach.

    04100Z5.................. Bypass abdominal aorta to bilateral renal

    artery, open approach.

    0410493.................. Bypass abdominal aorta to right renal artery

    with autologous venous tissue, percutaneous

    endoscopic approach.

    0410494.................. Bypass abdominal aorta to left renal artery

    with autologous venous tissue, percutaneous

    endoscopic approach.

    0410495.................. Bypass abdominal aorta to bilateral renal

    artery with autologous venous tissue,

    percutaneous endoscopic approach.

    04104A3.................. Bypass abdominal aorta to right renal artery

    with autologous arterial tissue,

    percutaneous endoscopic approach.

    Page 49375

    04104A4.................. Bypass abdominal aorta to left renal artery

    with autologous arterial tissue,

    percutaneous endoscopic approach.

    04104A5.................. Bypass abdominal aorta to bilateral renal

    artery with autologous arterial tissue,

    percutaneous endoscopic approach.

    04104J3.................. Bypass abdominal aorta to right renal artery

    with synthetic substitute, percutaneous

    endoscopic approach.

    04104J4.................. Bypass abdominal aorta to left renal artery

    with synthetic substitute, percutaneous

    endoscopic approach.

    04104J5.................. Bypass abdominal aorta to bilateral renal

    artery with synthetic substitute,

    percutaneous endoscopic approach.

    04104K3.................. Bypass abdominal aorta to right renal artery

    with nonautologous tissue substitute,

    percutaneous endoscopic approach

    04104K4.................. Bypass abdominal aorta to left renal artery

    with nonautologous tissue substitute,

    percutaneous endoscopic approach.

    04104K5.................. Bypass abdominal aorta to bilateral renal

    artery with nonautologous tissue substitute,

    percutaneous endoscopic approach.

    04104Z3.................. Bypass abdominal aorta to right renal artery,

    percutaneous endoscopic approach.

    04104Z4.................. Bypass abdominal aorta to left renal artery,

    percutaneous endoscopic approach.

    04104Z5.................. Bypass abdominal aorta to bilateral renal

    artery, percutaneous endoscopic approach

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 39.71

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

    ICD-10-PCS Code Code description

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

    04U03JZ.................. Supplement abdominal aorta with synthetic

    substitute, percutaneous approach.

    04U04JZ.................. Supplement abdominal aorta with synthetic

    substitute, percutaneous endoscopic

    approach.

    04V03DZ.................. Restriction of abdominal aorta with

    intraluminal device, percutaneous approach.

    04V04DZ.................. Restriction of abdominal aorta with

    intraluminal device, percutaneous endoscopic

    approach

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 39.78

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

    ICD-10-PCS Code Code description

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

    04793DZ.................. Dilation of right renal artery with

    intraluminal device, percutaneous approach.

    04794DZ.................. Dilation of right renal artery with

    intraluminal device, percutaneous endoscopic

    approach.

    047A3DZ.................. Dilation of left renal artery with

    intraluminal device, percutaneous approach.

    047A4DZ.................. Dilation of left renal artery with

    intraluminal device, percutaneous endoscopic

    approach.

    04753DZ.................. Dilation of superior mesenteric artery with

    intraluminal device, percutaneous approach.

    04754DZ.................. Dilation of superior mesenteric artery with

    intraluminal device, percutaneous endoscopic

    approach.

    04U03JZ.................. Supplement abdominal aorta with synthetic

    substitute, percutaneous approach.

    04U04JZ.................. Supplement abdominal aorta with synthetic

    substitute, percutaneous endoscopic

    approach.

    04V03DZ.................. Restriction of abdominal aorta with

    intraluminal device, percutaneous approach.

    04V04DZ.................. Restriction of abdominal aorta with

    intraluminal device, percutaneous endoscopic

    approach.

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

    For the next phase of our analysis, the procedure codes shown in the following table were designated as the less complex, less invasive procedures.

    ICD-9-CM Procedure Codes That Were Designated as the Less Complex, Less

    Invasive Procedures

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

    ICD-9-CM Procedure code Code description

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

    35.00.................... Closed heart valvotomy, unspecified valve.

    35.01.................... Closed heart valvotomy, aortic valve.

    35.02.................... Closed heart valvotomy, mitral valve.

    35.03.................... Closed heart valvotomy, pulmonary valve.

    35.04.................... Closed heart valvotomy, tricuspid valve.

    37.12.................... Pericardiotomy.

    37.24.................... Biopsy of pericardium.

    37.31.................... Pericardiectomy.

    37.61.................... Implant of pulsation balloon.

    37.67.................... Implantation of cardiomyostimulation system.

    37.91.................... Open chest cardiac massage.

    37.99.................... Other operations on heart and pericardium.

    38.05.................... Incision of vessel, other thoracic vessels.

    38.06.................... Incision of vessel, abdominal arteries.

    38.07.................... Incision of vessel, abdominal veins.

    38.15.................... Endarterectomy, other thoracic vessels.

    38.16.................... Endarterectomy, abdominal arteries.

    38.35.................... Resection of vessel with anastomosis, other

    thoracic vessels.

    38.36.................... Resection of vessel with anastomosis,

    abdominal arteries.

    38.37.................... Resection of vessel with anastomosis,

    abdominal veins.

    38.46.................... Resection of vessel with replacement,

    abdominal arteries.

    Page 49376

    38.47.................... Resection of vessel with replacement,

    abdominal veins.

    38.55.................... Ligation and stripping of varicose veins,

    other thoracic vessels.

    38.65.................... Other excision of vessels, thoracic vessels.

    38.66.................... Other excision of vessels, abdominal

    arteries.

    38.67.................... Other excision of vessels, abdominal veins.

    38.85.................... Other surgical occlusion of vessels, thoracic

    vessels.

    38.86.................... Other surgical occlusion of vessels,

    abdominal arteries.

    38.87.................... Other surgical occlusion of vessels,

    abdominal veins.

    39.0..................... Systemic to pulmonary artery shunt.

    39.1..................... Intra-abdominal venous shunt.

    39.21.................... Caval-pulmonary artery anastomosis.

    39.22.................... Aorta-subclavian-carotid bypass.

    39.23.................... Other intrathoracic vascular shunt or bypass.

    39.25.................... Aorta-iliac-femoral bypass.

    39.26.................... Other intra-abdominal vascular shunt or

    bypass.

    39.52.................... Other repair of aneurysm.

    39.54.................... Re-entry operation (aorta).

    39.72.................... Endovascular (total) embolization or

    occlusion of head and neck vessels.

    39.75.................... Endovascular embolization or occlusion of

    vessel(s) of head or neck using bare coils.

    39.76.................... Endovascular embolization or occlusion of

    vessel(s) of head or neck using bioactive

    coils.

    39.79.................... Other endovascular procedures on other

    vessels.

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

    There are a number of ICD-10-PCS code translations that provide more detailed and specific information for each of the ICD-9-CM codes listed in the table immediately above that also currently group to MS-

    DRGs 237 and 238 in the ICD-10 MS-DRGs Version 32. The comparable ICD-

    10-PCS code translations for these ICD-9-CM procedure codes are shown in the following tables:

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 35.00

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

    ICD-10-PCS Procedure code Code description

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

    02NF3ZZ.................. Release aortic valve, percutaneous approach.

    02NF4ZZ.................. Release aortic valve, percutaneous endoscopic

    approach.

    02NG3ZZ.................. Release mitral valve, percutaneous approach.

    02NG4ZZ.................. Release mitral valve, percutaneous endoscopic

    approach.

    02NH3ZZ.................. Release pulmonary valve, percutaneous

    approach.

    02NH4ZZ.................. Release pulmonary valve, percutaneous

    endoscopic approach.

    02NJ3ZZ.................. Release tricuspid valve, percutaneous

    approach.

    02NJ4ZZ.................. Release tricuspid valve, percutaneous

    endoscopic approach.

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 35.01

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

    ICD-10-PCS Procedure code Code description

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

    02CF3ZZ.................. Extirpation of matter from aortic valve,

    percutaneous approach.

    02CF4ZZ.................. Extirpation of matter from aortic valve,

    percutaneous endoscopic approach.

    02NF3ZZ.................. Release aortic valve, percutaneous approach.

    02NF4ZZ.................. Release aortic valve, percutaneous endoscopic

    approach.

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 35.02

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

    ICD-10-PCS Procedure code Code description

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

    02CG3ZZ.................. Extirpation of matter from mitral valve,

    percutaneous approach.

    02CG4ZZ.................. Extirpation of matter from mitral valve,

    percutaneous endoscopic approach.

    02NG3ZZ.................. Release mitral valve, percutaneous approach.

    02NG4ZZ.................. Release mitral valve, percutaneous endoscopic

    approach.

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

    Page 49377

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 35.03

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

    ICD-10-PCS Code Code description

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

    02CH3ZZ.................. Extirpation of matter from pulmonary valve,

    percutaneous approach.

    02CH4ZZ.................. Extirpation of matter from pulmonary valve,

    percutaneous endoscopic approach.

    02NH3ZZ.................. Release Pulmonary Valve, Percutaneous

    Approach.

    02NH4ZZ.................. Release Pulmonary Valve, Percutaneous

    Endoscopic Approach.

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 35.04

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

    ICD-10-PCS Code Code description

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

    02CJ3ZZ.................. Extirpation of matter from tricuspid valve,

    percutaneous approach.

    02CJ4ZZ.................. Extirpation of matter from tricuspid valve,

    percutaneous endoscopic approach.

    02NJ3ZZ.................. Release tricuspid valve, percutaneous

    approach.

    02NJ4ZZ.................. Release tricuspid valve, percutaneous

    endoscopic approach.

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 37.12

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

    ICD-10-PCS Code Code description

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

    02CN0ZZ.................. Extirpation of matter from pericardium, open

    approach.

    02CN3ZZ.................. Extirpation of matter from pericardium,

    percutaneous approach.

    02CN4ZZ.................. Extirpation of matter from pericardium,

    percutaneous endoscopic approach.

    02HN00Z.................. Insertion of pressure sensor monitoring

    device into pericardium, open approach.

    02HN02Z.................. Insertion of monitoring device into

    pericardium, open approach.

    02HN30Z.................. Insertion of pressure sensor monitoring

    device into pericardium, percutaneous

    approach.

    02HN32Z.................. Insertion of monitoring device into

    pericardium, percutaneous approach.

    02HN40Z.................. Insertion of pressure sensor monitoring

    device into pericardium, percutaneous

    endoscopic approach.

    02HN42Z.................. Insertion of monitoring device into

    pericardium, percutaneous endoscopic

    approach.

    02NN0ZZ.................. Release pericardium, open approach.

    02NN3ZZ.................. Release pericardium, percutaneous approach.

    02NN4ZZ.................. Release pericardium, percutaneous endoscopic

    approach.

    0W9D00Z.................. Drainage of pericardial cavity with drainage

    device, open approach.

    0W9D0ZX.................. Drainage of pericardial cavity, open

    approach, diagnostic.

    0W9D0ZZ.................. Drainage of pericardial cavity, open

    approach.

    0WCD0ZZ.................. Extirpation of matter from pericardial

    cavity, open approach.

    0WCD3ZZ.................. Extirpation of matter from pericardial

    cavity, percutaneous approach.

    0WCD4ZZ.................. Extirpation of matter from pericardial

    cavity, percutaneous endoscopic approach.

    0WHD03Z.................. Insertion of infusion device into pericardial

    cavity, open approach.

    0WHD0YZ.................. Insertion of other device into pericardial

    cavity, open approach.

    0WHD33Z.................. Insertion of infusion device into pericardial

    cavity, percutaneous approach.

    0WHD3YZ.................. Insertion of other device into pericardial

    cavity, percutaneous approach.

    0WHD43Z.................. Insertion of infusion device into pericardial

    cavity, percutaneous endoscopic approach.

    0WHD4YZ.................. Insertion of other device into pericardial

    cavity, percutaneous endoscopic approach.

    0WPD00Z.................. Removal of drainage device from pericardial

    cavity, open approach.

    0WPD01Z.................. Removal of radioactive element from

    pericardial cavity, open approach.

    0WPD03Z.................. Removal of infusion device from pericardial

    cavity, open approach.

    0WPD0YZ.................. Removal of other device from pericardial

    cavity, open approach.

    0WPD30Z.................. Removal of drainage device from pericardial

    cavity, percutaneous approach.

    0WPD31Z.................. Removal of radioactive element from

    pericardial cavity, percutaneous approach.

    0WPD33Z.................. Removal of infusion device from pericardial

    cavity, percutaneous approach.

    0WPD3YZ.................. Removal of other device from pericardial

    cavity, percutaneous approach.

    0WPD40Z.................. Removal of drainage device from pericardial

    cavity, percutaneous endoscopic approach.

    0WPD41Z.................. Removal of radioactive element from

    pericardial cavity, percutaneous endoscopic

    approach.

    0WPD43Z.................. Removal of infusion device from pericardial

    cavity, percutaneous endoscopic approach.

    0WPD4YZ.................. Removal of other device from pericardial

    cavity, percutaneous endoscopic approach.

    0WWD00Z.................. Revision of drainage device in pericardial

    cavity, open approach.

    0WWD01Z.................. Revision of radioactive element in

    pericardial cavity, open approach.

    0WWD03Z.................. Revision of infusion device in pericardial

    cavity, open approach.

    0WWD0YZ.................. Revision of other device in pericardial

    cavity, open approach.

    0WWD30Z.................. Revision of drainage device in pericardial

    cavity, percutaneous approach.

    0WWD31Z.................. Revision of radioactive element in

    pericardial cavity, percutaneous approach.

    0WWD33Z.................. Revision of infusion device in pericardial

    cavity, percutaneous approach.

    0WWD3YZ.................. Revision of other device in pericardial

    cavity, percutaneous approach.

    0WWD40Z.................. Revision of drainage device in pericardial

    cavity, percutaneous endoscopic approach.

    0WWD41Z.................. Revision of radioactive element in

    pericardial cavity, percutaneous endoscopic

    approach.

    0WWD43Z.................. Revision of infusion device in pericardial

    cavity, percutaneous endoscopic approach.

    0WWD4YZ.................. Revision of other device in pericardial

    cavity, percutaneous endoscopic approach.

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

    Page 49378

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 37.24

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

    ICD-10-PCS Code Code description

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

    02BN0ZX.................. Excision of pericardium, open approach,

    diagnostic.

    02BN3ZX.................. Excision of pericardium, percutaneous

    approach, diagnostic.

    02BN4ZX.................. Excision of pericardium, percutaneous

    endoscopic approach, diagnostic.

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 37.31

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

    ICD-10-PCS Code Code description

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

    025N0ZZ.................. Destruction of pericardium, open approach.

    025N3ZZ.................. Destruction of pericardium, percutaneous

    approach.

    025N4ZZ.................. Destruction of pericardium, percutaneous

    endoscopic approach.

    02BN0ZZ.................. Excision of pericardium, open approach.

    02BN3ZZ.................. Excision of pericardium, percutaneous

    approach.

    02BN4ZZ.................. Excision of pericardium, percutaneous

    endoscopic approach.

    02TN0ZZ.................. Resection of pericardium, open approach.

    02TN3ZZ.................. Resection of pericardium, percutaneous

    approach.

    02TN4ZZ.................. Resection of pericardium, percutaneous

    endoscopic approach.

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 37.61

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

    ICD-10-PCS Code Code description

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

    5A02110.................. Assistance with cardiac output using balloon

    pump, intermittent.

    5A02210.................. Assistance with cardiac output using balloon

    pump, continuous.

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 37.67

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

    ICD-10-PCS Code Code description

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

    02QA0ZZ.................. Repair heart, open approach.

    02QA3ZZ.................. Repair heart, percutaneous approach.

    02QA4ZZ.................. Repair heart, percutaneous endoscopic

    approach.

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 37.91

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

    ICD-10-PCS Code Code description

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

    02QA0ZZ.................. Repair heart, open approach.

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 37.99

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

    ICD-10-PCS Code Code description

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

    02880ZZ.................. Division of conduction mechanism, open

    approach.

    02883ZZ.................. Division of conduction mechanism,

    percutaneous approach.

    02884ZZ.................. Division of conduction mechanism,

    percutaneous endoscopic approach.

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 38.05

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

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

    The comparable ICD-10-PCS code translations for ICD-9-CM procedure code

    38.05 are shown in Table 6P.1b for this final rule, which is available

    via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html.

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 38.06

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

    ICD-10-PCS Code Code description

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

    04C10ZZ.................. Extirpation of matter from celiac artery,

    open approach.

    04C13ZZ.................. Extirpation of matter from celiac artery,

    percutaneous approach.

    Page 49379

    04C14ZZ.................. Extirpation of matter from celiac artery,

    percutaneous endoscopic approach.

    04C20ZZ.................. Extirpation of matter from gastric artery,

    open approach.

    04C23ZZ.................. Extirpation of matter from gastric artery,

    percutaneous approach.

    04C24ZZ.................. Extirpation of matter from gastric artery,

    percutaneous endoscopic approach.

    04C30ZZ.................. Extirpation of matter from hepatic artery,

    open approach.

    04C33ZZ.................. Extirpation of matter from hepatic artery,

    percutaneous approach.

    04C34ZZ.................. Extirpation of matter from hepatic artery,

    percutaneous endoscopic approach.

    04C40ZZ.................. Extirpation of matter from splenic artery,

    open approach.

    04C43ZZ.................. Extirpation of matter from splenic artery,

    percutaneous approach.

    04C44ZZ.................. Extirpation of matter from splenic artery,

    percutaneous endoscopic approach.

    04C50ZZ.................. Extirpation of matter from superior

    mesenteric artery, open approach.

    04C53ZZ.................. Extirpation of matter from superior

    mesenteric artery, percutaneous approach.

    04C54ZZ.................. Extirpation of matter from superior

    mesenteric artery, percutaneous endoscopic

    approach.

    04C60ZZ.................. Extirpation of matter from right colic

    artery, open approach.

    04C63ZZ.................. Extirpation of matter from right colic

    artery, percutaneous approach.

    04C64ZZ.................. Extirpation of matter from right colic

    artery, percutaneous endoscopic approach.

    04C70ZZ.................. Extirpation of matter from left colic artery,

    open approach.

    04C73ZZ.................. Extirpation of matter from left colic artery,

    percutaneous approach.

    04C74ZZ.................. Extirpation of matter from left colic artery,

    percutaneous endoscopic approach.

    04C80ZZ.................. Extirpation of matter from middle colic

    artery, open approach.

    04C83ZZ.................. Extirpation of matter from middle colic

    artery, percutaneous approach.

    04C84ZZ.................. Extirpation of matter from middle colic

    artery, percutaneous endoscopic approach.

    04C90ZZ.................. Extirpation of matter from right renal

    artery, open approach.

    04C93ZZ.................. Extirpation of matter from right renal

    artery, percutaneous approach.

    04C94ZZ.................. Extirpation of matter from right renal

    artery, percutaneous endoscopic approach.

    04CA0ZZ.................. Extirpation of matter from left renal artery,

    open approach.

    04CA3ZZ.................. Extirpation of matter from left renal artery,

    percutaneous approach.

    04CA4ZZ.................. Extirpation of matter from left renal artery,

    percutaneous endoscopic approach.

    04CB0ZZ.................. Extirpation of matter from inferior

    mesenteric artery, open approach.

    04CB3ZZ.................. Extirpation of matter from inferior

    mesenteric artery, percutaneous approach.

    04CB4ZZ.................. Extirpation of matter from inferior

    mesenteric artery, percutaneous endoscopic

    approach.

    04CC0ZZ.................. Extirpation of matter from right common iliac

    artery, open approach.

    04CC3ZZ.................. Extirpation of matter from right common iliac

    artery, percutaneous approach.

    04CC4ZZ.................. Extirpation of matter from right common iliac

    artery, percutaneous endoscopic approach.

    04CD0ZZ.................. Extirpation of matter from left common iliac

    artery, open approach.

    04CD3ZZ.................. Extirpation of matter from left common iliac

    artery, percutaneous approach.

    04CD4ZZ.................. Extirpation of matter from left common iliac

    artery, percutaneous endoscopic approach.

    04CE0ZZ.................. Extirpation of matter from right internal

    iliac artery, open approach.

    04CE3ZZ.................. Extirpation of matter from right internal

    iliac artery, percutaneous approach.

    04CE4ZZ.................. Extirpation of matter from right internal

    iliac artery, percutaneous endoscopic

    approach.

    04CF0ZZ.................. Extirpation of matter from left internal

    iliac artery, open approach.

    04CF3ZZ.................. Extirpation of matter from left internal

    iliac artery, percutaneous approach.

    04CF4ZZ.................. Extirpation of matter from left internal

    iliac artery, percutaneous endoscopic

    approach.

    04CH0ZZ.................. Extirpation of matter from right external

    iliac artery, open approach.

    04CH3ZZ.................. Extirpation of matter from right external

    iliac artery, percutaneous approach.

    04CH4ZZ.................. Extirpation of matter from right external

    iliac artery, percutaneous endoscopic

    approach.

    04CJ0ZZ.................. Extirpation of matter from left external

    iliac artery, open approach.

    04CJ3ZZ.................. Extirpation of matter from left external

    iliac artery, percutaneous approach.

    04CJ4ZZ.................. Extirpation of matter from left external

    iliac artery, percutaneous endoscopic

    approach.

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 38.07

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

    ICD-10-PCS Code Code description

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

    06C00ZZ.................. Extirpation of matter from inferior vena

    cava, open approach.

    06C03ZZ.................. Extirpation of matter from inferior vena

    cava, percutaneous approach.

    06C04ZZ.................. Extirpation of matter from inferior vena

    cava, percutaneous endoscopic approach.

    06C10ZZ.................. Extirpation of matter from splenic vein, open

    approach.

    06C13ZZ.................. Extirpation of matter from splenic vein,

    percutaneous approach.

    06C14ZZ.................. Extirpation of matter from splenic vein,

    percutaneous endoscopic approach.

    06C20ZZ.................. Extirpation of matter from gastric vein, open

    approach.

    06C23ZZ.................. Extirpation of matter from gastric vein,

    percutaneous approach.

    06C24ZZ.................. Extirpation of matter from gastric vein,

    percutaneous endoscopic approach.

    06C40ZZ.................. Extirpation of matter from hepatic vein, open

    approach.

    06C43ZZ.................. Extirpation of matter from hepatic vein,

    percutaneous approach.

    06C44ZZ.................. Extirpation of matter from hepatic vein,

    percutaneous endoscopic approach.

    06C50ZZ.................. Extirpation of matter from superior

    mesenteric vein, open approach.

    06C53ZZ.................. Extirpation of matter from superior

    mesenteric vein, percutaneous approach.

    06C54ZZ.................. Extirpation of matter from superior

    mesenteric vein, percutaneous endoscopic

    approach.

    Page 49380

    06C60ZZ.................. Extirpation of matter from inferior

    mesenteric vein, open approach.

    06C63ZZ.................. Extirpation of matter from inferior

    mesenteric vein, percutaneous approach.

    06C64ZZ.................. Extirpation of matter from inferior

    mesenteric vein, percutaneous endoscopic

    approach.

    06C70ZZ.................. Extirpation of matter from colic vein, open

    approach.

    06C73ZZ.................. Extirpation of matter from colic vein,

    percutaneous approach.

    06C74ZZ.................. Extirpation of matter from colic vein,

    percutaneous endoscopic approach.

    06C80ZZ.................. Extirpation of matter from portal vein, open

    approach.

    06C83ZZ.................. Extirpation of matter from portal vein,

    percutaneous approach.

    06C84ZZ.................. Extirpation of matter from portal vein,

    percutaneous endoscopic approach.

    06C90ZZ.................. Extirpation of matter from right renal vein,

    open approach.

    06C93ZZ.................. Extirpation of matter from right renal vein,

    percutaneous approach.

    06C94ZZ.................. Extirpation of matter from right renal vein,

    percutaneous endoscopic approach.

    06CB0ZZ.................. Extirpation of matter from left renal vein,

    open approach.

    06CB3ZZ.................. Extirpation of matter from left renal vein,

    percutaneous approach.

    06CB4ZZ.................. Extirpation of matter from left renal vein,

    percutaneous endoscopic approach.

    06CC0ZZ.................. Extirpation of matter from right common iliac

    vein, open approach.

    06CC3ZZ.................. Extirpation of matter from right common iliac

    vein, percutaneous approach.

    06CC4ZZ.................. Extirpation of matter from right common iliac

    vein, percutaneous endoscopic approach.

    06CD0ZZ.................. Extirpation of matter from left common iliac

    vein, open approach.

    06CD3ZZ.................. Extirpation of matter from left common iliac

    vein, percutaneous approach.

    06CD4ZZ.................. Extirpation of matter from left common iliac

    vein, percutaneous endoscopic approach.

    06CF0ZZ.................. Extirpation of matter from right external

    iliac vein, open approach.

    06CF3ZZ.................. Extirpation of matter from right external

    iliac vein, percutaneous approach.

    06CF4ZZ.................. Extirpation of matter from right external

    iliac vein, percutaneous endoscopic

    approach.

    06CG0ZZ.................. Extirpation of matter from left external

    iliac vein, open approach.

    06CG3ZZ.................. Extirpation of matter from left external

    iliac vein, percutaneous approach.

    06CG4ZZ.................. Extirpation of matter from left external

    iliac vein, percutaneous endoscopic

    approach.

    06CH0ZZ.................. Extirpation of matter from right hypogastric

    vein, open approach.

    06CH3ZZ.................. Extirpation of matter from right hypogastric

    vein, percutaneous approach.

    06CH4ZZ.................. Extirpation of matter from right hypogastric

    vein, percutaneous endoscopic approach.

    06CJ0ZZ.................. Extirpation of matter from left hypogastric

    vein, open approach.

    06CJ3ZZ.................. Extirpation of matter from left hypogastric

    vein, percutaneous approach.

    06CJ4ZZ.................. Extirpation of matter from left hypogastric

    vein, percutaneous endoscopic approach.

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 38.15

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

    ICD-10-PCS Code Code description

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

    02CP0ZZ.................. Extirpation of matter from pulmonary trunk,

    open approach.

    02CP3ZZ.................. Extirpation of matter from pulmonary trunk,

    percutaneous approach.

    02CP4ZZ.................. Extirpation of matter from pulmonary trunk,

    percutaneous endoscopic approach.

    02CQ0ZZ.................. Extirpation of matter from right pulmonary

    artery, open approach.

    02CQ3ZZ.................. Extirpation of matter from right pulmonary

    artery, percutaneous approach.

    02CQ4ZZ.................. Extirpation of matter from right pulmonary

    artery, percutaneous endoscopic approach.

    02CR0ZZ.................. Extirpation of matter from left pulmonary

    artery, open approach.

    02CR3ZZ.................. Extirpation of matter from left pulmonary

    artery, percutaneous approach.

    02CR4ZZ.................. Extirpation of matter from left pulmonary

    artery, percutaneous endoscopic approach.

    02CS0ZZ.................. Extirpation of matter from right pulmonary

    vein, open approach.

    02CS3ZZ.................. Extirpation of matter from right pulmonary

    vein, percutaneous approach.

    02CS4ZZ.................. Extirpation of matter from right pulmonary

    vein, percutaneous endoscopic approach.

    02CT0ZZ.................. Extirpation of matter from left pulmonary

    vein, open approach.

    02CT3ZZ.................. Extirpation of matter from left pulmonary

    vein, percutaneous approach.

    02CT4ZZ.................. Extirpation of matter from left pulmonary

    vein, percutaneous endoscopic approach.

    02CV0ZZ.................. Extirpation of matter from superior vena

    cava, open approach.

    02CV3ZZ.................. Extirpation of matter from superior vena

    cava, percutaneous approach.

    02CV4ZZ.................. Extirpation of matter from superior vena

    cava, percutaneous endoscopic approach.

    03C00ZZ.................. Extirpation of matter from right internal

    mammary artery, open approach.

    03C03ZZ.................. Extirpation of matter from right internal

    mammary artery, percutaneous approach.

    03C04ZZ.................. Extirpation of matter from right internal

    mammary artery, percutaneous endoscopic

    approach.

    03C10ZZ.................. Extirpation of matter from left internal

    mammary artery, open approach.

    03C13ZZ.................. Extirpation of matter from left internal

    mammary artery, percutaneous approach.

    03C14ZZ.................. Extirpation of matter from left internal

    mammary artery, percutaneous endoscopic

    approach.

    03C20ZZ.................. Extirpation of matter from innominate artery,

    open approach.

    03C23ZZ.................. Extirpation of matter from innominate artery,

    percutaneous approach.

    03C24ZZ.................. Extirpation of matter from innominate artery,

    percutaneous endoscopic approach.

    03C30ZZ.................. Extirpation of matter from right subclavian

    artery, open approach.

    03C33ZZ.................. Extirpation of matter from right subclavian

    artery, percutaneous approach.

    03C34ZZ.................. Extirpation of matter from right subclavian

    artery, percutaneous endoscopic approach.

    03C40ZZ.................. Extirpation of matter from left subclavian

    artery, open approach.

    Page 49381

    03C43ZZ.................. Extirpation of matter from left subclavian

    artery, percutaneous approach.

    03C44ZZ.................. Extirpation of matter from left subclavian

    artery, percutaneous endoscopic approach.

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 38.16

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

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

    The comparable ICD-10-PCS code translations for ICD-9-CM procedure code

    38.16 are shown in Table 6P.1c for this final rule, which is available

    via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html.

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 38.35

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

    ICD-10-PCS Code Code description

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

    02BP0ZZ.................. Excision of pulmonary trunk, open approach.

    02BP4ZZ.................. Excision of pulmonary trunk, percutaneous

    endoscopic approach.

    02BQ0ZZ.................. Excision of right pulmonary artery, open

    approach.

    02BQ4ZZ.................. Excision of right pulmonary artery,

    percutaneous endoscopic approach.

    02BR0ZZ.................. Excision of left pulmonary artery, open

    approach.

    02BR4ZZ.................. Excision of left pulmonary artery,

    percutaneous endoscopic approach.

    02BS0ZZ.................. Excision of right pulmonary vein, open

    approach.

    02BS4ZZ.................. Excision of right pulmonary vein,

    percutaneous endoscopic approach.

    02BT0ZZ.................. Excision of left pulmonary vein, open

    approach.

    02BT4ZZ.................. Excision of left pulmonary vein, percutaneous

    endoscopic approach.

    02BV0ZZ.................. Excision of superior vena cava, open

    approach.

    02BV4ZZ.................. Excision of superior vena cava, percutaneous

    endoscopic approach.

    03B00ZZ.................. Excision of right internal mammary artery,

    open approach.

    03B04ZZ.................. Excision of right internal mammary artery,

    percutaneous endoscopic approach.

    03B10ZZ.................. Excision of left internal mammary artery,

    open approach.

    03B14ZZ.................. Excision of left internal mammary artery,

    percutaneous endoscopic approach.

    03B20ZZ.................. Excision of innominate artery, open approach.

    03B24ZZ.................. Excision of innominate artery, percutaneous

    endoscopic approach.

    03B30ZZ.................. Excision of right subclavian artery, open

    approach.

    03B34ZZ.................. Excision of right subclavian artery,

    percutaneous endoscopic approach.

    03B40ZZ.................. Excision of left subclavian artery, open

    approach.

    03B44ZZ.................. Excision of left subclavian artery,

    percutaneous endoscopic approach.

    05B00ZZ.................. Excision of azygos vein, open approach.

    05B04ZZ.................. Excision of azygos vein, percutaneous

    endoscopic approach.

    05B10ZZ.................. Excision of hemiazygos vein, open approach.

    05B14ZZ.................. Excision of hemiazygos vein, percutaneous

    endoscopic approach.

    05B30ZZ.................. Excision of right innominate vein, open

    approach.

    05B34ZZ.................. Excision of right innominate vein,

    percutaneous endoscopic approach.

    05B40ZZ.................. Excision of left innominate vein, open

    approach.

    05B44ZZ.................. Excision of left innominate vein,

    percutaneous endoscopic approach.

    05B50ZZ.................. Excision of right subclavian vein, open

    approach.

    05B54ZZ.................. Excision of right subclavian vein,

    percutaneous endoscopic approach.

    05B60ZZ.................. Excision of left subclavian vein, open

    approach.

    05B64ZZ.................. Excision of left subclavian vein,

    percutaneous endoscopic approach.

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 38.36

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

    ICD-10-PCS Code Code description

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

    04B10ZZ.................. Excision of celiac artery, open approach.

    04B14ZZ.................. Excision of celiac artery, percutaneous

    endoscopic approach.

    04B20ZZ.................. Excision of gastric artery, open approach.

    04B24ZZ.................. Excision of gastric artery, percutaneous

    endoscopic approach.

    04B30ZZ.................. Excision of hepatic artery, open approach.

    04B34ZZ.................. Excision of hepatic artery, percutaneous

    endoscopic approach.

    04B40ZZ.................. Excision of splenic artery, open approach.

    04B44ZZ.................. Excision of splenic artery, percutaneous

    endoscopic approach.

    04B50ZZ.................. Excision of superior mesenteric artery, open

    approach.

    04B54ZZ.................. Excision of superior mesenteric artery,

    percutaneous endoscopic approach.

    04B60ZZ.................. Excision of right colic artery, open

    approach.

    04B64ZZ.................. Excision of right colic artery, percutaneous

    endoscopic approach.

    04B70ZZ.................. Excision of left colic artery, open approach.

    04B74ZZ.................. Excision of left colic artery, percutaneous

    endoscopic approach.

    Page 49382

    04B80ZZ.................. Excision of middle colic artery, open

    approach.

    04B84ZZ.................. Excision of middle colic artery, percutaneous

    endoscopic approach.

    04B90ZZ.................. Excision of right renal artery, open

    approach.

    04B94ZZ.................. Excision of right renal artery, percutaneous

    endoscopic approach.

    04BA0ZZ.................. Excision of left renal artery, open approach.

    04BA4ZZ.................. Excision of left renal artery, percutaneous

    endoscopic approach.

    04BB0ZZ.................. Excision of inferior mesenteric artery, open

    approach.

    04BB4ZZ.................. Excision of inferior mesenteric artery,

    percutaneous endoscopic approach.

    04BC0ZZ.................. Excision of right common iliac artery, open

    approach.

    04BC4ZZ.................. Excision of right common iliac artery,

    percutaneous endoscopic approach.

    04BD0ZZ.................. Excision of left common iliac artery, open

    approach.

    04BD4ZZ.................. Excision of left common iliac artery,

    percutaneous endoscopic approach.

    04BE0ZZ.................. Excision of right internal iliac artery, open

    approach.

    04BE4ZZ.................. Excision of right internal iliac artery,

    percutaneous endoscopic approach.

    04BF0ZZ.................. Excision of left internal iliac artery, open

    approach.

    04BF4ZZ.................. Excision of left internal iliac artery,

    percutaneous endoscopic approach.

    04BH0ZZ.................. Excision of right external iliac artery, open

    approach.

    04BH4ZZ.................. Excision of right external iliac artery,

    percutaneous endoscopic approach.

    04BJ0ZZ.................. Excision of left external iliac artery, open

    approach.

    04BJ4ZZ.................. Excision of left external iliac artery,

    percutaneous endoscopic approach.

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 38.37

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

    ICD-10-PCS Code Code description

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

    06B00ZZ.................. Excision of inferior vena cava, open

    approach.

    06B04ZZ.................. Excision of inferior vena cava, percutaneous

    endoscopic approach.

    06B10ZZ.................. Excision of splenic vein, open approach.

    06B14ZZ.................. Excision of splenic vein, percutaneous

    endoscopic approach.

    06B20ZZ.................. Excision of gastric vein, open approach.

    06B24ZZ.................. Excision of gastric vein, percutaneous

    endoscopic approach.

    06B40ZZ.................. Excision of hepatic vein, open approach.

    06B44ZZ.................. Excision of hepatic vein, percutaneous

    endoscopic approach.

    06B50ZZ.................. Excision of superior mesenteric vein, open

    approach.

    06B54ZZ.................. Excision of superior mesenteric vein,

    percutaneous endoscopic approach.

    06B60ZZ.................. Excision of inferior mesenteric vein, open

    approach.

    06B64ZZ.................. Excision of inferior mesenteric vein,

    percutaneous endoscopic approach.

    06B70ZZ.................. Excision of colic vein, open approach.

    06B74ZZ.................. Excision of colic vein, percutaneous

    endoscopic approach.

    06B80ZZ.................. Excision of portal vein, open approach.

    06B84ZZ.................. Excision of portal vein, percutaneous

    endoscopic approach.

    06B90ZZ.................. Excision of right renal vein, open approach.

    06B94ZZ.................. Excision of right renal vein, percutaneous

    endoscopic approach.

    06BB0ZZ.................. Excision of left renal vein, open approach.

    06BB4ZZ.................. Excision of left renal vein, percutaneous

    endoscopic approach.

    06BC0ZZ.................. Excision of right common iliac vein, open

    approach.

    06BC4ZZ.................. Excision of right common iliac vein,

    percutaneous endoscopic approach.

    06BD0ZZ.................. Excision of left common iliac vein, open

    approach.

    06BD4ZZ.................. Excision of left common iliac vein,

    percutaneous endoscopic approach.

    06BF0ZZ.................. Excision of right external iliac vein, open

    approach.

    06BF4ZZ.................. Excision of right external iliac vein,

    percutaneous endoscopic approach.

    06BG0ZZ.................. Excision of left external iliac vein, open

    approach.

    06BG4ZZ.................. Excision of left external iliac vein,

    percutaneous endoscopic approach.

    06BH0ZZ.................. Excision of right hypogastric vein, open

    approach.

    06BH4ZZ.................. Excision of right hypogastric vein,

    percutaneous endoscopic approach.

    06BJ0ZZ.................. Excision of left hypogastric vein, open

    approach.

    06BJ4ZZ.................. Excision of left hypogastric vein,

    percutaneous endoscopic approach.

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 38.46

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

    ICD-10-PCS Code Code description

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

    The comparable ICD-10-PCS code translations for ICD-9-CM procedure code

    38.46 are shown in Table 6P.1d for this final rule, which is available

    via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html..

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

    Page 49383

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 38.47

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

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

    The comparable ICD-10-PCS code translations for ICD-9-CM procedure code

    38.47 are shown in Table 6P.1e for this final rule, which is available

    via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html.

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

    There is not an equivalent ICD-10-PCS code translation for ICD-9-CM procedure code 38.55.

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 38.65

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

    ICD-10-PCS Code Code description

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

    The comparable ICD-10-PCS code translations for ICD-9-CM procedure code

    38.65 are shown in Table 6P.1f for this final rule, which is available

    via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html..

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 38.66

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

    ICD-10-PCS Code Code description

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

    The comparable ICD-10-PCS code translations for ICD-9-CM procedure code

    38.66 are shown in Table 6P.1g for this final rule, which is available

    via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html..

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 38.67

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

    ICD-10-PCS Code Code description

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

    The comparable ICD-10-PCS code translations for ICD-9-CM procedure code

    38.67 are shown in Table 6P.1h for this final rule, which is available

    via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html..

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 38.85

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

    ICD-10-PCS Code Code description

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

    The comparable ICD-10-PCS code translations for ICD-9-CM procedure code

    38.85 are shown in Table 6P.1i for this final rule, which is available

    via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html..

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 38.86

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

    ICD-10-PCS Code Code description

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

    The comparable ICD-10-PCS code translations for ICD-9-CM procedure code

    38.86 are shown in Table 6P.1j for this final rule, which is available

    via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html..

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 38.87

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

    ICD-10-PCS Code Code description

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

    The comparable ICD-10-PCS code translations for ICD-9-CM procedure code

    38.87 are shown in Table 6P.1k for this final rule, which is available

    via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html..

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

    Page 49384

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 39.0

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

    ICD-10-PCS Code Code description

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

    The comparable ICD-10-PCS code translations for ICD-9-CM procedure code

    39.0 are shown in Table 6P.1l for this final rule, which is available

    via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html..

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 39.1

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

    ICD-10-PCS Code Code description

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

    The comparable ICD-10-PCS code translations for ICD-9-CM procedure code

    39.1 are shown in Table 6P.1m for this final rule, which is available

    via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html..

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 39.21

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

    ICD-10-PCS Code Code description

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

    021V09P.................. Bypass superior vena cava to pulmonary trunk

    with autologous venous tissue, open

    approach.

    021V09Q.................. Bypass superior vena cava to right pulmonary

    artery with autologous venous tissue, open

    approach.

    021V09R.................. Bypass superior vena cava to left pulmonary

    artery with autologous venous tissue, open

    approach.

    021V0AP.................. Bypass superior vena cava to pulmonary trunk

    with autologous arterial tissue, open

    approach.

    021V0AQ.................. Bypass superior vena cava to right pulmonary

    artery with autologous arterial tissue, open

    approach.

    021V0AR.................. Bypass superior vena cava to left pulmonary

    artery with autologous arterial tissue, open

    approach.

    021V0JP.................. Bypass superior vena cava to pulmonary trunk

    with synthetic substitute, open approach.

    021V0JQ.................. Bypass superior vena cava to right pulmonary

    artery with synthetic substitute, open

    approach.

    021V0JR.................. Bypass superior vena cava to left pulmonary

    artery with synthetic substitute, open

    approach.

    021V0KP.................. Bypass superior vena cava to pulmonary trunk

    with nonautologous tissue substitute, open

    approach.

    021V0KQ.................. Bypass superior vena cava to right pulmonary

    artery with nonautologous tissue substitute,

    open approach.

    021V0KR.................. Bypass superior vena cava to left pulmonary

    artery with nonautologous tissue substitute,

    open approach.

    021V0ZP.................. Bypass superior vena cava to pulmonary trunk,

    open approach.

    021V0ZQ.................. Bypass superior vena cava to right pulmonary

    artery, open approach.

    021V0ZR.................. Bypass superior vena cava to left pulmonary

    artery, open approach.

    021V49P.................. Bypass superior vena cava to pulmonary trunk

    with autologous venous tissue, percutaneous

    endoscopic approach.

    021V49Q.................. Bypass superior vena cava to right pulmonary

    artery with autologous venous tissue,

    percutaneous endoscopic approach.

    021V49R.................. Bypass superior vena cava to left pulmonary

    artery with autologous venous tissue,

    percutaneous endoscopic approach.

    021V4AP.................. Bypass superior vena cava to pulmonary trunk

    with autologous arterial tissue,

    percutaneous endoscopic approach.

    021V4AQ.................. Bypass superior vena cava to right pulmonary

    artery with autologous arterial tissue,

    percutaneous endoscopic approach.

    021V4AR.................. Bypass superior vena cava to left pulmonary

    artery with autologous arterial tissue,

    percutaneous endoscopic approach.

    021V4JP.................. Bypass superior vena cava to pulmonary trunk

    with synthetic substitute, percutaneous

    endoscopic approach.

    021V4JQ.................. Bypass superior vena cava to right pulmonary

    artery with synthetic substitute,

    percutaneous endoscopic approach.

    021V4JR.................. Bypass superior vena cava to left pulmonary

    artery with synthetic substitute,

    percutaneous endoscopic approach.

    021V4KP.................. Bypass superior vena cava to pulmonary trunk

    with nonautologous tissue substitute,

    percutaneous endoscopic approach.

    021V4KQ.................. Bypass superior vena cava to right pulmonary

    artery with nonautologous tissue substitute,

    percutaneous endoscopic approach.

    021V4KR.................. Bypass superior vena cava to left pulmonary

    artery with nonautologous tissue substitute,

    percutaneous endoscopic approach.

    021V4ZP.................. Bypass superior vena cava to pulmonary trunk,

    percutaneous endoscopic approach.

    021V4ZQ.................. Bypass superior vena cava to right pulmonary

    artery, percutaneous endoscopic approach.

    021V4ZR.................. Bypass superior vena cava to left pulmonary

    artery, percutaneous endoscopic approach.

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 39.22

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

    ICD-10-PCS Code Code description

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

    021W09B.................. Bypass thoracic aorta to subclavian with

    autologous venous tissue, open approach).

    021W09D.................. Bypass thoracic aorta to carotid with

    autologous venous tissue, open approach).

    021W0AB.................. Bypass thoracic aorta to subclavian with

    autologous arterial tissue, open approach.

    021W0AD.................. Bypass thoracic aorta to carotid with

    autologous arterial tissue, open approach.

    021W0JB.................. Bypass thoracic aorta to subclavian with

    synthetic substitute, open approach.

    021W0JD.................. Bypass thoracic aorta to carotid with

    synthetic substitute, open approach.

    021W0KB.................. Bypass thoracic aorta to subclavian with

    nonautologous tissue substitute, open

    approach.

    021W0KD.................. Bypass thoracic aorta to carotid with

    nonautologous tissue substitute, open

    approach.

    021W0ZB.................. Bypass thoracic aorta to subclavian, open

    approach.

    021W0ZD.................. Bypass thoracic aorta to carotid, open

    approach.

    021W49B.................. Bypass thoracic aorta to subclavian with

    autologous venous tissue, percutaneous

    endoscopic approach.

    021W49D.................. Bypass thoracic aorta to carotid with

    autologous venous tissue, percutaneous

    endoscopic approach.

    021W4AB.................. Bypass thoracic aorta to subclavian with

    autologous arterial tissue, percutaneous

    endoscopic approach.

    021W4AD.................. Bypass thoracic aorta to carotid with

    autologous arterial tissue, percutaneous

    endoscopic approach.

    Page 49385

    021W4JB.................. Bypass thoracic aorta to subclavian with

    synthetic substitute, percutaneous

    endoscopic approach.

    021W4JD.................. Bypass thoracic aorta to carotid with

    synthetic substitute, percutaneous

    endoscopic approach.

    021W4KB.................. Bypass thoracic aorta to subclavian with

    nonautologous tissue substitute,

    percutaneous endoscopic approach.

    021W4KD.................. Bypass thoracic aorta to carotid with

    nonautologous tissue substitute,

    percutaneous endoscopic approach.

    021W4ZB.................. Bypass thoracic aorta to subclavian,

    percutaneous endoscopic approach.

    021W4ZD.................. Bypass thoracic aorta to carotid,

    percutaneous endoscopic approach.

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 39.23

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

    ICD-10-PCS Code Code description

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

    The comparable ICD-10-PCS code translations for ICD-9-CM procedure code

    39.23 are shown in Table 6P.1n for this final rule, which is available

    via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html..

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 39.25

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

    ICD-10-PCS Code Code description

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

    The comparable ICD-10-PCS code translations for ICD-9-CM procedure code

    39.25 are shown in Table 6P.1o for this final rule, which is available

    via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html..

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 39.26

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

    ICD-10-PCS Code Code description

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

    The comparable ICD-10-PCS code translations for ICD-9-CM procedure code

    39.26 are shown in Table 6P.1p for this final rule, which is available

    via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html..

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 39.52

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

    ICD-10-PCS Code Code description

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

    The comparable ICD-10-PCS code translations for ICD-9-CM procedure code

    39.52 are shown in Table 6P.1q for this final rule, which is available

    via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html..

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 39.54

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

    ICD-10-PCS Code Code description

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

    02QW0ZZ.................. Repair thoracic aorta, open approach.

    02QW3ZZ.................. Repair thoracic aorta, percutaneous approach.

    02QW4ZZ.................. Repair thoracic aorta, percutaneous

    endoscopic approach.

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 39.72

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

    ICD-10-PCS Code Code description

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

    03LR0DZ.................. Occlusion of face artery with intraluminal

    device, open approach.

    03LR3DZ.................. Occlusion of face artery with intraluminal

    device, percutaneous approach.

    03LR4DZ.................. Occlusion of face artery with intraluminal

    device, percutaneous endoscopic approach.

    03LS0DZ.................. Occlusion of right temporal artery with

    intraluminal device, open approach.

    03LS3DZ.................. Occlusion of right temporal artery with

    intraluminal device, percutaneous approach.

    03LS4DZ.................. Occlusion of right temporal artery with

    intraluminal device, percutaneous endoscopic

    approach.

    03LT0DZ.................. Occlusion of left temporal artery with

    intraluminal device, open approach.

    03LT3DZ.................. Occlusion of left temporal artery with

    intraluminal device, percutaneous approach.

    Page 49386

    03LT4DZ.................. Occlusion of left temporal artery with

    intraluminal device, percutaneous endoscopic

    approach.

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 39.75

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

    ICD-10-PCS Code Code description

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

    The comparable ICD-10-PCS code translations for ICD-9-CM procedure code

    39.75 are shown in Table 6P.1r for this final rule, which is available

    via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html..

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 39.76

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

    ICD-10-PCS Code Code description

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

    The comparable ICD-10-PCS code translations for ICD-9-CM procedure code

    39.76 are shown in Table 6P.1s for this final rule, which is available

    via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html..

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

    ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 39.79

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

    ICD-10-PCS Code Code description

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

    The comparable ICD-10-PCS code translations for ICD-9-CM procedure code

    39.79 are shown in Table 6P.1t for this final rule, which is available

    via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html..

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

    As previously stated, we separated the more complex, more invasive procedures from the less complex, less invasive procedures to continue our evaluation of the procedures assigned to MS-DRGs 237 and 238. Our data analysis showed that the distribution of cases, the average length of stay, and average costs of the more complex, more invasive aortic and heart assist procedures and the less complex, less invasive other cardiovascular procedures would be more appropriately reflected if we classified these distinguishing types of procedures under newly created MS-DRGs, as reflected in the table below.

    Major Cardiovascular Procedures with and without MCC

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

    Number of Average length

    MS-DRG cases of stay Average costs

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

    MS-DRGs 237 and 238--Combined................................... 50,567 5.8 $29,174

    MS-DRGs 237 and 238--Cases with more complex, more invasive 22,278 4.0 31,729

    procedure codes (37.41; 37.49; 37.55; 37.64; 38.04; 38.14;

    38.34; 38.44; 38.64; 38.84; 39.24; 39.71, and 39.78)...........

    MS-DRGs 237 and 238--Cases with less complex, less invasive 28,289 7.1 27,162

    procedure codes (35.00; 35.01; 35.02; 35.03; 35.04; 37.12;

    37.24; 37.31; 37.61; 37.67; 37.91; 37.99; 38.05; 38.06; 38.07;

    38.15; 38.16; 38.35; 38.36; 38.37; 38.46; 38.47; 38.55; 38.65;

    38.66; 38.67; 38.85; 38.86; 38.87; 39.0; 39.1; 39.21; 39.22;

    39.23; 39.25; 39.26; 39.52; 39.54; 39.72; 39.75; 39.76; and

    39.79).........................................................

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

    Our clinical advisors reviewed the results of the analysis and agreed that distinguishing the more complex, more invasive procedures from the less complex, less invasive procedures would result in improved clinical coherence for the various cardiovascular procedures currently assigned to MS-DRGs 237 and 238, as listed previously. Therefore, for FY 2016, we proposed to delete MS-DRGs 237 and 238. When we applied our established criteria to determine if the creation of a new CC or MCC subgroup within a base MS-DRG is warranted, we determined that a 2-way severity level split (with MCC and without MCC) was justified. Therefore, we proposed to create two new MS-DRGs that would contain the more complex, more invasive aortic and heart assist procedures currently assigned to MS-DRGs 237 and 238, as listed previously. We proposed to create MS-DRG 268, entitled ``Aortic and Heart Assist Procedures Except Pulsation Balloon with MCC,'' and MS-DRG 269, entitled ``Aortic and Heart Assist Procedures Except Pulsation Balloon without MCC.'' The table below shows the distribution of cases and the average length of stay and average costs of the more complex, more invasive procedures for aortic and heart assistance for the proposed new MS-DRGs 268 and 269.

    Page 49387

    Proposed New MS-DRGs for Aortic and Heart Assist Procedures

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

    Number of Average length

    MS-DRG cases of stay Average costs

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

    Proposed New MS-DRG 268 with MCC................................ 4,182 10.03 $45,996

    Proposed New MS-DRG 269 without MCC............................. 18,096 2.68 28,431

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

    We invited public comments on this proposal and the ICD-10-PCS code translations for these procedures shown earlier in this section, which we also proposed to assign to proposed new MS-DRGs 268 and 269.

    In addition, when we further applied our established criteria to determine if the creation of a new CC or MCC subgroup for the remaining procedures was warranted, we determined that a 3-way severity level split (with MCC, with CC, and without CC/MCC) was justified. Therefore, we proposed to create three new MS-DRGs that would contain the remaining cardiovascular procedures that were designated as the less complex, less invasive procedures, as listed previously. For FY 2016, we proposed to create MS-DRG 270, entitled ``Other Major Cardiovascular Procedures with MCC''; MS-DRG 271, entitled ``Other Major Cardiovascular Procedures with CC''; and MS-DRG 272, entitled ``Other Major Cardiovascular Procedures without CC/MCC,'' and to assign the less complex, less invasive cardiovascular procedures shown earlier in this section to these proposed new MS-DRGs. We believed that, as shown in the table below, the distribution of cases and average length of stay and average costs of these procedures would be more appropriately reflected when these types of procedures are classified under these proposed new MS-DRGs.

    Proposed New MS-DRGs for Other Major Cardiovascular Procedures

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

    Number of Average length

    MS-DRG cases of stay Average costs

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

    Proposed New MS-DRG 270 with MCC................................ 14,158 9.3 $33,507

    Proposed New MS-DRG 271 with CC................................. 9,648 5.99 22,800

    Proposed New MS-DRG 272 without CC/MCC.......................... 4,483 3.08 16,438

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

    We invited public comments on this proposal and the ICD-10-PCS code translations for the less complex, less invasive cardiovascular procedures shown earlier in this section, which we also proposed to assign to proposed new MS-DRGs 270, 271, and 272.

    In summary, for FY 2016, we proposed to delete MS-DRGs 237 and 238, and to create the following five new MS-DRGs:

    Proposed new MS-DRG 268 (Aortic and Heart Assist Procedures Except Pulsation Balloon with MCC);

    Proposed new MS-DRG 269 (Aortic and Heart Assist Procedures Except Pulsation Balloon without MCC);

    Proposed new MS-DRG 270 (Other Major Cardiovascular Procedures with MCC);

    Proposed new MS-DRG 271 (Other Major Cardiovascular Procedures with CC); and

    Proposed new MS-DRG 272 (Other Major Cardiovascular Procedures without CC/MCC).

    We also proposed to assign the more complex, more invasive cardiovascular procedures identified in our analysis and the ICD-10-PCS code translations to proposed new MS-DRGs 268 and 269. In addition, we proposed to assign the less complex, less invasive cardiovascular procedures identified in our analysis and the ICD-10-PCS code translations to proposed new MS-DRGs 270, 271, and 272. We encouraged public comments on our proposal to create these proposed new MS-DRGs, as well as the ICD-10-PCS code translations that we proposed to assign to the corresponding proposed new MS-DRGs.

    Comment: Several commenters supported the proposal to delete MS-

    DRGs 237 and 238 and to create five new proposed MS-DRGs 268, 269, 270, 271, and 272 to distinguish the more complex, more invasive procedures from the less complex, less invasive procedures resulting in improved clinical coherence for the various cardiovascular procedures currently assigned to MS-DRGs 237 and 238. Commenters stated that the proposal was reasonable, given the data and information provided.

    One commenter who supported the creation of proposed new MS-DRGs 268 and 269 expressed additional support with regard to how these proposed new MS-DRGs would incorporate selected high resource surgical aortic and visceral vessel procedures, as well as selected high resource extra-cardiac procedures. The commenter agreed that, in terms of resource utilization and clinical coherency, the procedures included would be classified appropriately to the proposed new MS-DRGs. However, this commenter requested clarification on some of the ICD-10-PCS code translations that were listed for ICD-9-CM procedure code 39.78 (Endovascular implantation of branching or fenestrated graft(s) in aorta). The commenter stated that, as displayed in the FY 2016 IPPS/

    LTCH PPS proposed rule (80 FR 24363), the dilation of right and left renal arteries and the superior mesenteric artery (procedures described by ICD-10-PCS codes 04793DZ through 04754DZ) also appear to be proposed for grouping to proposed MS-DRGs 268 and 269. The commenter believed that CMS did not intend to classify those dilation codes as ``stand alone'' procedures that would be assigned to proposed new MS-DRGs 268 and 269. The commenter stated that the ICD-10-PCS dilation codes should not be necessary as translations for ICD-9-CM procedure code 39.78.

    Another commenter commended CMS on the timing of the proposal to establish proposed new MS-DRGs 268 and 269. The commenter stated that this proposal will allow patients requiring fenestrated grafts continued access to care in FY 2016, as the new-technology add-on payment for the Zenith Fenestrated Graft device is expiring September 30, 2015. The commenter also stated that, currently, there is not an appropriate mechanism to ensure access to these procedures, especially in rural hospitals, and that this proposal would change that.

    Other commenters stated that the proposed new MS-DRGs would better recognize clinical homogeneity and

    Page 49388

    resource requirements for the range of major cardiovascular procedures.

    Response: We appreciate the commenters' support of our proposal to delete MS-DRGs 237 and 238 and to create proposed new MS-DRGs 268 through 272.

    In response to the comment requesting clarification on some of the ICD-10-PCS code translations that were listed for ICD-9-CM procedure code 39.78, the commenter is correct. It was not our intent to classify those dilation codes (ICD-10-PCS codes 04793DZ through 04754DZ) as ``stand alone'' procedures that would be assigned to proposed new MS-

    DRGs 268 and 269. Rather, we proposed those codes for consideration as supplemental codes to more fully describe the procedure performed. We agree with the commenter that these dilation codes are not necessary translations for ICD-9-CM procedure code 39.78 and as ``stand alone'' procedures they would be assigned to their own separate and clinically appropriate ICD-10 MS-DRG.

    As we reviewed the translations for ICD-9-CM procedure code 39.78 in response to the commenter's request, we reviewed all the comparable ICD-10-PCS code translations that we proposed to assign to proposed new MS-DRGs 268 through 272. Specifically, we reviewed the list of the more complex, more invasive procedures that we proposed to assign to proposed MS-DRGs 268 and 269 and the list of the less complex, less invasive procedures that we proposed to assign to proposed MS-DRGs 270 through 272. We determined that the ICD-10-PCS translations for ICD-9-

    CM procedure code 37.49 (Other repair of heart and pericardium) as displayed in Table 6P.1a of the proposed rule were not complete. There was an inadvertent omission of an additional 78 ICD-10-PCS comparable code translations. Therefore, we are providing an updated Table 6P for this final rule, which is available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html. We note that this list of ICD-10-PCS code translations for ICD-9-CM procedure code 37.49 is consistent with the list of possible code translations found in the General Equivalency Maps (GEMs) files provided for public use available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD10/index.html.

    In conducting this review, our clinical advisors also determined that ICD-9-CM procedure code 37.49 and the corresponding ICD-10-PCS comparable code translations would be more appropriately classified under proposed new MS-DRGs 270 through 272 versus proposed new MS-DRGs 268 and 269. This decision is consistent with our proposal to assign less invasive procedures, such as pericardiotomies and pulsation balloon implants, to proposed new MS-DRGs 270 through 272. This procedure code captures procedures that are similar to the other procedures included in the proposal for MS-DRGs 270 through 272 involving the pericardium such as ICD-9-CM procedure codes 37.12 (Pericardiotomy), 37.24 (Biopsy of pericardium) and 37.61 (Pericardiectomy) and does not relate to the more complex, more invasive aortic and heart assist procedures that we proposed to assign to proposed MS-DRGs 268 and 269. According to our clinical advisors, the ICD-10-PCS code translations for ICD-9-CM procedure code 37.49 also do not constitute the level of complexity or resources similar to the other procedures that we proposed to assign to proposed new MS-DRGs 268 and 269. In addition, our clinical advisors determined that ICD-9-CM procedure code 39.54 (Re-entry operation (aorta)) and the corresponding ICD-10-PCS comparable code translations would be more appropriately classified under proposed new MS-DRGs 268 through 269 versus proposed new MS-DRGs 270 through 272. This decision is consistent with our proposal to assign more invasive procedures, such as open and endovascular repairs of the aorta with replacement grafts, to proposed new MS-DRGs 268 and 269. According to our clinical advisors, the procedure described by ICD-9-CM procedure code 39.54 and the comparable ICD-10-PCS code translations are precisely indicated for the aorta, and, as such, the procedure code belongs under proposed new MS-DRGs 268 and 269 along with the other aorta and heart assist procedures.

    Comment: One commenter requested clarification on certain ICD-10-

    PCS code translations for proposed new MS-DRGs 268 through 272 and how they relate to the General Equivalency Maps (GEMs) and ICD-10-PCS to ICD-9-CM Reimbursement Mappings files. The commenter noted that there were instances where more than one ICD-9-CM procedure code could be translated to an ICD-10-PCS code that was included in the proposed new MS-DRGs, as well as listed in the Reimbursement Mappings file. The commenter submitted an example where ICD-10-PCS code 04V00DZ (Restriction of abdominal aorta with intraluminal device, open approach) was listed as a comparable ICD-10-PCS translation for ICD-9-

    CM procedure code 39.52 (Other repair of aneurysm) in the proposal for proposed new MS-DRGs 270 through 272. However, the commenter stated that, in the FY 2015 Reimbursement Mappings file, this same ICD-10-PCS code (04V00DZ) was shown to map to ICD-9-CM procedure code 39.71 (Endovascular implantation of other graft in abdominal aorta), which was included in the proposal for proposed new MS-DRGs 268 and 269. The commenter asked if the FY 2016 Reimbursement Mappings file would be updated to reflect that ICD-10-PCS code 04V00DZ maps back to ICD-9-CM procedure code 39.52.

    Response: We acknowledge and appreciate the commenter's request for clarification. We point out that the General Equivalence Mappings (GEMs) and Reimbursement Mappings files were developed as resources for the public and are updated separate from the IPPS rulemaking. The GEMs were developed to provide users with a code to code translation reference tool for both ICD-9-CM and ICD-10 codes sets and to offer acceptable translation alternatives where possible. The Reimbursement Mappings were created to provide a temporary mechanism for mapping records containing ICD-10 codes to ``MS-DRG reimbursement minimum impact'' ICD-9-CM codes and allow claims processing by legacy systems while systems were being converted to process ICD-10 claims directly. The GEMs have been updated on an annual basis as part of the ICD-10 Coordination and Maintenance Committee meetings process and will continue to be updated for approximately 3 years after ICD-10 is implemented. We refer readers to the ICD-10 Coordination and Maintenance Committee Meeting Materials for further information related to discussion of GEMs updates, which can be found on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/ICD-9-CM-C-and-M-Meeting-Materials.html. The Reimbursement Mappings have been updated on an annual basis in preparation for the transition to ICD-10 implementation. As stated on the CMS ICD-10 Coordination and Maintenance Committee Meeting Web page available on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD10/2016-ICD-10-PCS-and-GEMs.html, the FY 2016 Reimbursement Mappings files will be posted in August 2015.

    Comment: One commenter who supported proposed new MS-DRGs 268 and 269 requested that CMS revise the

    Page 49389

    titles to address concerns expressed by stakeholders. According to the commenter, the proposed titles have caused confusion among providers and consultants. The commenter suggested that CMS consider the following three modifications:

    Indicate that MS-DRGs 268 and 269 are aortic procedures, not aortic heart assist devices;

    Indicate that MS-DRGs 268 and 269 are assigned to heart assist removal or repair, and not the multitude of other heart assist insertion procedures not addressed in the proposed rule; and

    Remove the reference to pulsation balloon insertion, or add the reference to proposed new MS-DRGs 270 through 272 (Other Major Cardiovascular Procedures with MCC, with CC and without CC/MCC, respectively).

    The commenter noted that the titles for proposed new MS-DRGs 268 and 269 contain the phrase ``Heart Assist Procedures''. However, the commenter stated that not all heart assist procedures are proposed to be assigned to these MS-DRGs; essentially, it is only the removal of heart assist procedures codes that are included. The commenter further noted that other heart assist procedures such as insertion of heart assist devices are identified in several other MS-DRGs, such as MS-DRGs 001 and 002 (Heart Transplant or Implant of Heart Assist System w MCC and without MCC, respectively) and that external heart assist devices are identified in MS-DRG 215 (Other Heart Assist System Implant), while heart assist devices inserted percutaneously with cardiac catheterization are identified in MS-DRGs 216 through 218 (Cardiac Valve & Other Major Cardiothoracic Procedures with Cardiac Catheterization with MCC, with CC and without CC/MCC, respectively).

    The commenter also stated that the reference to ``Except Pulsation Balloon'' in the titles for proposed new MS-DRGs 268 and 269 indicates that all aortic and heart assist procedures would be included except pulsation balloon. The commenter asserted that the titles could cause confusion for stakeholders because there are other procedures that are nonpulsation balloon, heart assist procedures that correspond to the titles for proposed new MS-DRGs 268 and 269 and are assigned to other MS-DRGs. The commenter requested that CMS delete the terminology of pulsation balloon completely or remove it from proposed new MS-DRGs 268 and 269 and add it to proposed new MS-DRGs 270 through 272. The commenter maintained that incorporating the reference to pulsation balloon into proposed new MS-DRGs 270 through 272 would afford a clearer understanding of the procedures that are assigned for providers.

    The commenter provided suggestions for the revision to the titles that CMS should take into consideration for proposed new MS-DRGs 268 through 272 as follows:

    Suggested retitle of proposed new MS-DRG 268: ``Aortic Procedures and Heart Assist Removal or Repair with MCC'';

    Suggested retitle of proposed new MS-DRG 269: ``Aortic Procedures and Heart Assist Removal or Repair without MCC'';

    Suggested retitle of proposed new MS-DRG 270: ``Pulsation Balloon and Other Major Cardiovascular Procedures with MCC'';

    Suggested retitle of proposed new MS-DRG 271: ``Pulsation Balloon and Other Major Cardiovascular Procedures with CC''; and

    Suggested retitle of proposed new MS-DRG 272: ``Pulsation Balloon and Other Major Cardiovascular Procedures without CC/MCC''.

    Response: We acknowledge the commenter's request to consider revisions to the titles for proposed new MS-DRGs 268 through 272. However, we note that we did not receive any other comments from stakeholders expressing confusion with regard to the titles for these proposed new MS-DRGs or the assignment of heart assist procedures.

    The commenter is correct that not all heart assist procedures are being proposed for assignment to proposed new MS-DRGs 268 and 269. As the commenter pointed out, there are other heart assist procedures that group to various MS-DRGs. The proposal was based on ICD-9-CM procedure codes that are currently assigned to MS-DRGs 237 and 238 and the corresponding ICD-10-PCS code translations for proposed new MS-DRGs 268 through 272. We believe that stakeholders understand that the MS-DRG system is a classification scheme consisting of clinically similar groups of patients with similar resource intensity, and that while the titles of the MS-DRGs reflect the category of procedures which may or may not be assigned to a particular MS-DRG, they do not specifically identify the details of each applicable procedure code. We also believe that stakeholders do not rely solely on the MS-DRG titles to determine what procedures are assigned to a particular MS-DRG. Rather, they would consult the MS-DRG Definitions Manual. The MS-DRG Definitions Manual contains the complete documentation of the MS-DRG GROUPER logic and is available from 3M/HIS, which, under contract with CMS, is responsible for updating and maintaining the GROUPER program. As discussed in the FY 2015 IPPS/LTCH PPS final rule (79 FR 49905 through 49906), the MS-

    DRG Definitions Manual, Version 32, which includes the FY 2015 MS-DRG changes is available on a CD for $225. This manual may be obtained by writing 3M/HIS at the following address: 100 Barnes Road, Wallingford, CT 06492; or by calling (203) 949-0303; or by obtaining an order form at the Web site at: http://www/3MHIS.com. In addition, as discussed in section II.G.1.a. of this final rule, in November 2014, CMS made available a Definitions Manual of the ICD-10 MS-DRGs Version 32 on the ICD-10 MS-DRG Conversion Project Web site at: http://www.cms.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-Project.html. Accordingly, we do not believe that the reference to ``Heart Assist Procedures'' in the title for proposed new MS-DRGs 268 and 269 would create confusion.

    For this same reason, we also do not believe that including the reference to ``except pulsation balloon'' in the titles for proposed new MS-DRGs 268 and 269, to accurately reflect that the pulsation balloon procedure is not assigned to those MS-DRGs, necessarily indicates that all other aortic and heart assist procedures are included. We would expect stakeholders to consult the MS-DRG Definitions Manual as described above to identify and determine whether a particular procedure is assigned to MS-DRG 268 or 269 or to another MS-DRG, rather than relying on the MS-DRGs title alone.

    After consideration of the public comments received, we are adopting as final our proposal to delete ICD-9-CM MS-DRGs 237 and 238 and add the following five new MS-DRGs to ICD-10 MS-DRGs Version 33:

    MS-DRG 268 (Aortic and Heart Assist Procedures Except Pulsation Balloon with MCC);

    MS-DRG 269 (Aortic and Heart Assist Procedures Except Pulsation Balloon without MCC);

    MS-DRG 270 (Other Major Cardiovascular Procedures with MCC);

    MS-DRG 271 (Other Major Cardiovascular Procedures with CC); and

    MS-DRG 272 (Other Major Cardiovascular Procedures without CC/MCC)

    We agree that these modifications will more appropriately reflect payment while recognizing differences in complexity, resources and severity of illness for the various cardiovascular

    Page 49390

    procedures. These finalized ICD-10 MS-DRGs will include the updated assignments discussed above related to the ICD-10-PCS code translations for ICD-9-CM codes 37.49 (Other repair of heart and pericardium) and 39.54 (Re-entry operation (aorta)). We also refer readers to the updated Table 6P for this final rule which is available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html. Lastly, we will consider if further modifications to the titles of these MS-DRGs are warranted in future rulemaking.

    4. MDC 8 (Diseases and Disorders of the Musculoskeletal System and Connective Tissue)

  194. Revision of Hip or Knee Replacements: Proposed Revision of ICD-10-

    PCS Version 32 Logic

    We received two comments that the logic for ICD-10 MS-DRGs Version 32 does not work the same as it does for the ICD-9-CM based MS-DRGs Version 32 for procedures involving joint revisions. One of the commenters requested that CMS change the MS-DRG structure for procedures involving joint revisions within the ICD-10 MS-DRGs 466, 467, and 468 (Revision of Hip or Knee Replacement with MCC, with CC, and without CC/MCC, respectively) so that cases that have a spacer removed prior to the insertion of a new joint prosthesis are assigned to MS-DRG 466, 467, and 468, as is the case with the ICD-9-CM MS-DRGs. The other commenter asked that joint revision cases that involve knee revisions with cemented and uncemented qualifiers be assigned to these MS-DRGs. This commenter provided an example of a patient admitted for a knee revision and reported under ICD-10-PCS codes 0SPD0JZ (Removal of synthetic substitute from left knee joint, open approach) and 0SRU0JA (Replacement of left knee joint, femoral surface with synthetic substitute, uncemented, open approach), which should be assigned to MS-

    DRGs 466, 467, and 468. The requestor stated that joint revision cases reported with ICD-9-CM codes are assigned to MS-DRGs 466, 467, and 468, but similar cases reported with the corresponding ICD-10-PCS codes are not assigned to MS-DRGs 466, 467, and 468 in ICD-10-PCS MS-DRGs Version 32.

    We agree that joint revision cases involving the removal of a spacer and subsequent insertion of a new joint prosthesis should be assigned to ICD-10 MS-DRGs 466, 467, and 468 as is the case currently with the ICD-9-CM based MS-DRGs Version 32. We also agree that knee revision cases that involve cemented and uncemented qualifiers should be assigned to ICD-10 MS-DRGs 466, 467, and 468. Knee revision cases currently reported with ICD-9-CM codes are assigned to MS-DRGs 466, 467, and 468 in the ICD-9-CM based MS-DRGs. We examined joint revision combination codes that are not currently assigned to MS-DRGs 466, 467, and 468 in ICD-10 MS-DRGs Version 32 and identified additional combinations that also should be included so that the joint revision ICD-10 MS-DRGs would have the same logic as the ICD-9-CM MS-DRGs. In the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24379 through 24395), we proposed to add code combinations listed in a table in the proposed rule that would capture the joint revisions to the Version 33 MS-DRG structure for ICD-10 MS-DRGs 466, 467, and 468 that we proposed to implement effective October 1, 2015. We invited public comments on our proposal to add the joint revision code combinations to MS-DRGs 466, 467, and 468 that were listed in the table in the proposed rule (80 FR 24379 through 24395).

    Comment: A number of commenters supported the proposal to add the joint revision code combinations to MS-DRGs 466, 467, and 468. The commenters stated that the proposal was reasonable, given the data and information provided. One commenter commended CMS for its careful review of these code pairs for hip and knee revision cases and supported the proposed updates. Another commenter supported the proposed MS-DRG assignment changes which the commenter believed would help to ensure that the ICD-10 MS-DRGs capture the appropriate ICD-10 procedure codes. One commenter stated that the proposed MS-DRG assignment changes improve alignment of these cases under the ICD-10 framework.

    Response: We appreciate the commenters' support for our proposal.

    After consideration of the public comments we received, we are finalizing our proposal to add code combinations which capture the joint revision procedures set forth in the table below to the Version 33 MS-DRG structure for ICD-10 MS-DRGs 466, 467, and 468 that will be implemented effective October 1, 2015. We note that joint revision procedures are also included in the ICD-9-CM version of MS-DRGs 628, 629, and 630 (Other Endocrine, Nutritional, and Metabolic Operating Room Procedures with MCC, with CC, and without CC/MCC, respectively). Therefore, to ensure that the joint revision ICD-10 MS-DRGs would have the same logic as the ICD-9-CM MS-DRGs, any updates to the joint revision combinations would apply to MS-DRGs 466, 467, and 468 as well as MS-DRGs 628, 629, and 630 because both sets of MS-DRGs contain the same joint revision codes. These comparable joint revisions combinations updates also will be made to MS-DRGs 628, 629, and 630 in the Version 33 MS-DRG structure for ICD-10 to maintain consistency with the logic for the ICD-9-CM MS-DRGs, effective October 1, 2015. Therefore, the joint revision combination codes that we are finalizing in this final rule are the same for MS-DRGs 466, 467, 468, 628, 629, and 630 and are reflected in the updated table below.

    MS-DRGs 466-468 and 628-630 ICD-10-PCS Code Pairs Added to the Version 33 ICD-10 MS-DRGs 466, 467, 468, 628,

    629, and 630: New Hip Revision ICD-10-PCS Combinations

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

    ICD-10-PCS code Code description ICD-10-PCS code Code description

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

    0SP908Z.................. Removal of spacer from and 0SR9019.................. Replacement of right hip

    right hip joint, open joint with metal

    approach. synthetic substitute,

    cemented, open

    approach.

    0SP908Z.................. Removal of spacer from and 0SR901A.................. Replacement of right hip

    right hip joint, open joint with metal

    approach. synthetic substitute,

    uncemented, open

    approach.

    0SP908Z.................. Removal of spacer from and 0SR901Z.................. Replacement of right hip

    right hip joint, open joint with metal

    approach. synthetic substitute,

    open approach.

    0SP908Z.................. Removal of spacer from and 0SR9029.................. Replacement of right hip

    right hip joint, open joint with metal on

    approach. polyethylene synthetic

    substitute, cemented,

    open approach.

    Page 49391

    0SP908Z.................. Removal of spacer from and 0SR902A.................. Replacement of right hip

    right hip joint, open joint with metal on

    approach. polyethylene synthetic

    substitute, uncemented,

    open approach.

    0SP908Z.................. Removal of spacer from and 0SR902Z.................. Replacement of right hip

    right hip joint, open joint with metal on

    approach. polyethylene synthetic

    substitute, open

    approach.

    0SP908Z.................. Removal of spacer from and 0SR9039.................. Replacement of right hip

    right hip joint, open joint with ceramic

    approach. synthetic substitute,

    cemented, open

    approach.

    0SP908Z.................. Removal of spacer from and 0SR903A.................. Replacement of right hip

    right hip joint, open joint with ceramic

    approach. synthetic substitute,

    uncemented, open

    approach.

    0SP908Z.................. Removal of spacer from and 0SR903Z.................. Replacement of right hip

    right hip joint, open joint with ceramic

    approach. synthetic substitute,

    open approach.

    0SP908Z.................. Removal of spacer from and 0SR9049.................. Replacement of right hip

    right hip joint, open joint with ceramic on

    approach. polyethylene synthetic

    substitute, cemented,

    open approach.

    0SP908Z.................. Removal of spacer from and 0SR904A.................. Replacement of right hip

    right hip joint, open joint with ceramic on

    approach. polyethylene synthetic

    substitute, uncemented,

    open approach.

    0SP908Z.................. Removal of spacer from and 0SR904Z.................. Replacement of right hip

    right hip joint, open joint with ceramic on

    approach. polyethylene synthetic

    substitute, open

    approach.

    0SP908Z.................. Removal of spacer from and 0SR90J9.................. Replacement of right hip

    right hip joint, open joint with synthetic

    approach. substitute, cemented,

    open approach.

    0SP908Z.................. Removal of spacer from and 0SR90JA.................. Replacement of right hip

    right hip joint, open joint with synthetic

    approach. substitute, uncemented,

    open approach.

    0SP908Z.................. Removal of spacer from and 0SR90JZ.................. Replacement of right hip

    right hip joint, open joint with synthetic

    approach. substitute, open

    approach.

    0SP908Z.................. Removal of spacer from and 0SRA009.................. Replacement of right hip

    right hip joint, open joint, acetabular

    approach. surface with

    polyethylene synthetic

    substitute, cemented,

    open approach.

    0SP908Z.................. Removal of spacer from and 0SRA00A.................. Replacement of right hip

    right hip joint, open joint, acetabular

    approach. surface with

    polyethylene synthetic

    substitute, uncemented,

    open approach.

    0SP908Z.................. Removal of spacer from and 0SRA00Z.................. Replacement of right hip

    right hip joint, open joint, acetabular

    approach. surface with

    polyethylene synthetic

    substitute, open

    approach.

    0SP908Z.................. Removal of spacer from and 0SRA019.................. Replacement of right hip

    right hip joint, open joint, acetabular

    approach. surface with metal

    synthetic substitute,

    cemented, open

    approach.

    0SP908Z.................. Removal of spacer from and 0SRA01A.................. Replacement of right hip

    right hip joint, open joint, acetabular

    approach. surface with metal

    synthetic substitute,

    uncemented, open

    approach.

    0SP908Z.................. Removal of spacer from and 0SRA01Z.................. Replacement of right hip

    right hip joint, open joint, acetabular

    approach. surface with metal

    synthetic substitute,

    open approach.

    0SP908Z.................. Removal of spacer from and 0SRA039.................. Replacement of right hip

    right hip joint, open joint, acetabular

    approach. surface with ceramic

    synthetic substitute,

    cemented, open

    approach.

    0SP908Z.................. Removal of spacer from and 0SRA03A.................. Replacement of right hip

    right hip joint, open joint, acetabular

    approach. surface with ceramic

    synthetic substitute,

    uncemented, open

    approach.

    0SP908Z.................. Removal of spacer from and 0SRA03Z.................. Replacement of right hip

    right hip joint, open joint, acetabular

    approach. surface with ceramic

    synthetic substitute,

    open approach.

    0SP908Z.................. Removal of spacer from and 0SRA0J9.................. Replacement of right hip

    right hip joint, open joint, acetabular

    approach. surface with synthetic

    substitute, cemented,

    pen approach.

    0SP908Z.................. Removal of spacer from and 0SRA0JA.................. Replacement of right hip

    right hip joint, open joint, acetabular

    approach. surface with synthetic

    substitute, uncemented,

    open approach.

    0SP908Z.................. Removal of spacer from and 0SRA0JZ.................. Replacement of right hip

    right hip joint, open joint, acetabular

    approach. surface with synthetic

    substitute, open

    approach.

    0SP908Z.................. Removal of spacer from and 0SRR019.................. Replacement of right hip

    right hip joint, open joint, femoral surface

    approach. with metal synthetic

    substitute, cemented,

    open approach.

    0SP908Z.................. Removal of spacer from and 0SRR01A.................. Replacement of right hip

    right hip joint, open joint, femoral surface

    approach. with metal synthetic

    substitute, uncemented,

    open approach.

    0SP908Z.................. Removal of spacer from and 0SRR01Z.................. Replacement of right hip

    right hip joint, open joint, femoral surface

    approach. with metal synthetic

    substitute, open

    approach.

    Page 49392

    0SP908Z.................. Removal of spacer from and 0SRR039.................. Replacement of right hip

    right hip joint, open joint, femoral surface

    approach. with ceramic synthetic

    substitute, cemented,

    open approach.

    0SP908Z.................. Removal of spacer from and 0SRR03A.................. Replacement of right hip

    right hip joint, open joint, femoral surface

    approach. with ceramic synthetic

    substitute, uncemented,

    open approach.

    0SP908Z.................. Removal of spacer from and 0SRR03Z.................. Replacement of right hip

    right hip joint, open joint, femoral surface

    approach. with ceramic synthetic

    substitute, open

    approach.

    0SP908Z.................. Removal of spacer from and 0SRR0J9.................. Replacement of right hip

    right hip joint, open joint, femoral surface

    approach. with synthetic

    substitute, cemented,

    open approach.

    0SP908Z.................. Removal of spacer from and 0SRR0JA.................. Replacement of right hip

    right hip joint, open joint, femoral surface

    approach. with synthetic

    substitute, uncemented,

    open approach.

    0SP908Z.................. Removal of spacer from and 0SRR0JZ.................. Replacement of right hip

    right hip joint, open joint, femoral surface

    approach. with synthetic

    substitute, open

    approach.

    0SP908Z.................. Removal of spacer from and 0SU909Z.................. Supplement right hip

    right hip joint, open joint with liner, open

    approach. approach.

    0SP908Z.................. Removal of spacer from and 0SUA09Z.................. Supplement right hip

    right hip joint, open joint, acetabular

    approach. surface with liner,

    open approach.

    0SP908Z.................. Removal of spacer from and 0SUR09Z.................. Supplement right hip

    right hip joint, open joint, femoral surface

    approach. with liner, open

    approach.

    0SP909Z.................. Removal of liner from and 0SR9019.................. Replacement of right hip

    right hip joint, open joint with metal

    approach. synthetic substitute,

    cemented, open

    approach.

    0SP909Z.................. Removal of liner from and 0SR901A.................. Replacement of right hip

    right hip joint, open joint with metal

    approach. synthetic substitute,

    uncemented, open

    approach.

    0SP909Z.................. Removal of liner from and 0SR901Z.................. Replacement of right hip

    right hip joint, open joint with metal

    approach. synthetic substitute,

    open approach.

    0SP909Z.................. Removal of liner from and 0SR9029.................. Replacement of right hip

    right hip joint, open joint with metal on

    approach. polyethylene synthetic

    substitute, cemented,

    open approach.

    0SP909Z.................. Removal of liner from and 0SR902A.................. Replacement of right hip

    right hip joint, open joint with metal on

    approach. polyethylene synthetic

    substitute, uncemented,

    open approach.

    0SP909Z.................. Removal of liner from and 0SR902Z.................. Replacement of right hip

    right hip joint, open joint with metal on

    approach. polyethylene synthetic

    substitute, open

    approach.

    0SP909Z.................. Removal of liner from and 0SR9039.................. Replacement of right hip

    right hip joint, open joint with ceramic

    approach. synthetic substitute,

    cemented, open

    approach.

    0SP909Z.................. Removal of liner from and 0SR903A.................. Replacement of right hip

    right hip joint, open joint with ceramic

    approach. synthetic substitute,

    uncemented, open

    approach.

    0SP909Z.................. Removal of liner from and 0SR903Z.................. Replacement of right hip

    right hip joint, open joint with ceramic

    approach. synthetic substitute,

    open approach.

    0SP909Z.................. Removal of liner from and 0SR9049.................. Replacement of right hip

    right hip joint, open joint with ceramic on

    approach. polyethylene synthetic

    substitute, cemented,

    open approach.

    0SP909Z.................. Removal of liner from and 0SR904A.................. Replacement of right hip

    right hip joint, open joint with ceramic on

    approach. polyethylene synthetic

    substitute, uncemented,

    open approach.

    0SP909Z.................. Removal of liner from and 0SR904Z.................. Replacement of right hip

    right hip joint, open joint with ceramic on

    approach. polyethylene synthetic

    substitute, open

    approach.

    0SP909Z.................. Removal of liner from and 0SR90J9.................. Replacement of right hip

    right hip joint, open joint with synthetic

    approach. substitute, cemented,

    open approach.

    0SP909Z.................. Removal of liner from and 0SR90JA.................. Replacement of right hip

    right hip joint, open joint with synthetic

    approach. substitute, uncemented,

    open approach.

    0SP909Z.................. Removal of liner from and 0SR90JZ.................. Replacement of right hip

    right hip joint, open joint with synthetic

    approach. substitute, open

    approach.

    0SP909Z.................. Removal of liner from and 0SRA009.................. Replacement of right hip

    right hip joint, open joint, acetabular

    approach. surface with

    polyethylene synthetic

    substitute, cemented,

    open approach.

    0SP909Z.................. Removal of liner from and 0SRA00A.................. Replacement of right hip

    right hip joint, open joint, acetabular

    approach. surface with

    polyethylene synthetic

    substitute, uncemented,

    open approach.

    0SP909Z.................. Removal of liner from and 0SRA00Z.................. Replacement of right hip

    right hip joint, open joint, acetabular

    approach. surface with

    polyethylene synthetic

    substitute, open

    approach.

    0SP909Z.................. Removal of liner from and 0SRA019.................. Replacement of right hip

    right hip joint, open joint, acetabular

    approach. surface with metal

    synthetic substitute,

    cemented, open

    approach.

    0SP909Z.................. Removal of liner from and 0SRA01A.................. Replacement of right hip

    right hip joint, open joint, acetabular

    approach. surface with metal

    synthetic substitute,

    uncemented, open

    approach.

    Page 49393

    0SP909Z.................. Removal of liner from and 0SRA01Z.................. Replacement of right hip

    right hip joint, open joint, acetabular

    approach. surface with metal

    synthetic substitute,

    open approach.

    0SP909Z.................. Removal of liner from and 0SRA039.................. Replacement of right hip

    right hip joint, open joint, acetabular

    approach. surface with ceramic

    synthetic substitute,

    cemented, open

    approach.

    0SP909Z.................. Removal of liner from and 0SRA03A.................. Replacement of right hip

    right hip joint, open joint, acetabular

    approach. surface with ceramic

    synthetic substitute,

    uncemented, open

    approach.

    0SP909Z.................. Removal of liner from and 0SRA03Z.................. Replacement of right hip

    right hip joint, open joint, acetabular

    approach. surface with ceramic

    synthetic substitute,

    open approach.

    0SP909Z.................. Removal of liner from and 0SRA0J9.................. Replacement of right hip

    right hip joint, open joint, acetabular

    approach. surface with synthetic

    substitute, cemented,

    open approach.

    0SP909Z.................. Removal of liner from and 0SRA0JA.................. Replacement of right hip

    right hip joint, open joint, acetabular

    approach. surface with synthetic

    substitute, uncemented,

    open approach.

    0SP909Z.................. Removal of liner from and 0SRA0JZ.................. Replacement of right hip

    right hip joint, open joint, acetabular

    approach. surface with synthetic

    substitute, open

    approach.

    0SP909Z.................. Removal of liner from and 0SRR019.................. Replacement of right hip

    right hip joint, open joint, femoral surface

    approach. with metal synthetic

    substitute, cemented,

    open approach.

    0SP909Z.................. Removal of liner from and 0SRR01A.................. Replacement of right hip

    right hip joint, open joint, femoral surface

    approach. with metal synthetic

    substitute, uncemented,

    open approach.

    0SP909Z.................. Removal of liner from and 0SRR01Z.................. Replacement of right hip

    right hip joint, open joint, femoral surface

    approach. with metal synthetic

    substitute, open

    approach.

    0SP909Z.................. Removal of liner from and 0SRR039.................. Replacement of right hip

    right hip joint, open joint, femoral surface

    approach. with ceramic synthetic

    substitute, cemented,

    open approach.

    0SP909Z.................. Removal of liner from and 0SRR03A.................. Replacement of right hip

    right hip joint, open joint, femoral surface

    approach. with ceramic synthetic

    substitute, uncemented,

    open approach.

    0SP909Z.................. Removal of liner from and 0SRR03Z.................. Replacement of right hip

    right hip joint, open joint, femoral surface

    approach. with ceramic synthetic

    substitute, open

    approach.

    0SP909Z.................. Removal of liner from and 0SRR0J9.................. Replacement of right hip

    right hip joint, open joint, femoral surface

    approach. with synthetic

    substitute, cemented,

    open approach.

    0SP909Z.................. Removal of liner from and 0SRR0JA.................. Replacement of right hip

    right hip joint, open joint, femoral surface

    approach. with synthetic

    substitute, uncemented,

    open approach.

    0SP909Z.................. Removal of liner from and 0SRR0JZ.................. Replacement of right hip

    right hip joint, open joint, femoral surface

    approach. with synthetic

    substitute, open

    approach.

    0SP909Z.................. Removal of liner from and 0SU909Z.................. Supplement right hip

    right hip joint, open joint with liner, open

    approach. approach.

    0SP909Z.................. Removal of liner from and 0SUA09Z.................. Supplement right hip

    right hip joint, open joint, acetabular

    approach. surface with liner,

    open approach.

    0SP909Z.................. Removal of liner from and 0SUR09Z.................. Supplement right hip

    right hip joint, open joint, femoral surface

    approach. with liner, open

    approach.

    0SP90BZ.................. Removal of resurfacing and 0SR9019.................. Replacement of right hip

    device from right hip joint with metal

    joint, open approach. synthetic substitute,

    cemented, open

    approach.

    0SP90BZ.................. Removal of resurfacing and 0SR901A.................. Replacement of right hip

    device from right hip joint with metal

    joint, open approach. synthetic substitute,

    uncemented, open

    approach.

    0SP90BZ.................. Removal of resurfacing and 0SR901Z.................. Replacement of right hip

    device from right hip joint with metal

    joint, open approach. synthetic substitute,

    open approach.

    0SP90BZ.................. Removal of resurfacing and 0SR9029.................. Replacement of right hip

    device from right hip joint with metal on

    joint, open approach. polyethylene synthetic

    substitute, cemented,

    open approach.

    0SP90BZ.................. Removal of resurfacing and 0SR902A.................. Replacement of right hip

    device from right hip joint with metal on

    joint, open approach. polyethylene synthetic

    substitute, uncemented,

    open approach.

    0SP90BZ.................. Removal of resurfacing and 0SR902Z.................. Replacement of right hip

    device from right hip joint with metal on

    joint, open approach. polyethylene synthetic

    substitute, open

    approach.

    0SP90BZ.................. Removal of resurfacing and 0SR9039.................. Replacement of right hip

    device from right hip joint with ceramic

    joint, open approach. synthetic substitute,

    cemented, open

    approach.

    0SP90BZ.................. Removal of resurfacing and 0SR903A.................. Replacement of right hip

    device from right hip joint with ceramic

    joint, open approach. synthetic substitute,

    uncemented, open

    approach.

    0SP90BZ.................. Removal of resurfacing and 0SR903Z.................. Replacement of right hip

    device from right hip joint with ceramic

    joint, open approach. synthetic substitute,

    open approach.

    Page 49394

    0SP90BZ.................. Removal of resurfacing and 0SR9049.................. Replacement of right hip

    device from right hip joint with ceramic on

    joint, open approach. polyethylene synthetic

    substitute, cemented,

    open approach.

    0SP90BZ.................. Removal of resurfacing and 0SR904A.................. Replacement of right hip

    device from right hip joint with ceramic on

    joint, open approach. polyethylene synthetic

    substitute, uncemented,

    open approach.

    0SP90BZ.................. Removal of resurfacing and 0SR904Z.................. Replacement of right hip

    device from right hip joint with ceramic on

    joint, open approach. polyethylene synthetic

    substitute, open

    approach.

    0SP90BZ.................. Removal of resurfacing and 0SR90J9.................. Replacement of right hip

    device from right hip joint with synthetic

    joint, open approach. substitute, cemented,

    open approach.

    0SP90BZ.................. Removal of resurfacing and 0SR90JA.................. Replacement of right hip

    device from right hip joint with synthetic

    joint, open approach. substitute, uncemented,

    open approach.

    0SP90BZ.................. Removal of resurfacing and 0SR90JZ.................. Replacement of right hip

    device from right hip joint with synthetic

    joint, open approach. substitute, open

    approach.

    0SP90BZ.................. Removal of resurfacing and 0SRA009.................. Replacement of right hip

    device from right hip joint, acetabular

    joint, open approach. surface with

    polyethylene synthetic

    substitute, cemented,

    open approach.

    0SP90BZ.................. Removal of resurfacing and 0SRA00A.................. Replacement of right hip

    device from right hip joint, acetabular

    joint, open approach. surface with

    polyethylene synthetic

    substitute, uncemented,

    open approach.

    0SP90BZ.................. Removal of resurfacing and 0SRA00Z.................. Replacement of right hip

    device from right hip joint, acetabular

    joint, open approach. surface with

    polyethylene synthetic

    substitute, open

    approach.

    0SP90BZ.................. Removal of resurfacing and 0SRA019.................. Replacement of right hip

    device from right hip joint, acetabular

    joint, open approach. surface with metal

    synthetic substitute,

    cemented, open

    approach.

    0SP90BZ.................. Removal of resurfacing and 0SRA01A.................. Replacement of right hip

    device from right hip joint, acetabular

    joint, open approach. surface with metal

    synthetic substitute,

    uncemented, open

    approach.

    0SP90BZ.................. Removal of resurfacing and 0SRA01Z.................. Replacement of right hip

    device from right hip joint, acetabular

    joint, open approach. surface with metal

    synthetic substitute,

    open approach.

    0SP90BZ.................. Removal of resurfacing and 0SRA039.................. Replacement of right hip

    device from right hip joint, acetabular

    joint, open approach. surface with ceramic

    synthetic substitute,

    cemented, open

    approach.

    0SP90BZ.................. Removal of resurfacing and 0SRA03A.................. Replacement of right hip

    device from right hip joint, acetabular

    joint, open approach. surface with ceramic

    synthetic substitute,

    uncemented, open

    approach.

    0SP90BZ.................. Removal of resurfacing and 0SRA03Z.................. Replacement of right hip

    device from right hip joint, acetabular

    joint, open approach. surface with ceramic

    synthetic substitute,

    open approach.

    0SP90BZ.................. Removal of resurfacing and 0SRA0J9.................. Replacement of right hip

    device from right hip joint, acetabular

    joint, open approach. surface with synthetic

    substitute, cemented,

    open approach.

    0SP90BZ.................. Removal of resurfacing and 0SRA0JA.................. Replacement of right hip

    device from right hip joint, acetabular

    joint, open approach. surface with synthetic

    substitute, uncemented,

    open approach.

    0SP90BZ.................. Removal of resurfacing and 0SRA0JZ.................. Replacement of right hip

    device from right hip joint, acetabular

    joint, open approach. surface with synthetic

    substitute, open

    approach.

    0SP90BZ.................. Removal of resurfacing and 0SRR019.................. Replacement of right hip

    device from right hip joint, femoral surface

    joint, open approach. with metal synthetic

    substitute, cemented,

    open approach.

    0SP90BZ.................. Removal of resurfacing and 0SRR01A.................. Replacement of right hip

    device from right hip joint, femoral surface

    joint, open approach. with metal synthetic

    substitute, uncemented,

    open approach.

    0SP90BZ.................. Removal of resurfacing and 0SRR01Z.................. Replacement of right hip

    device from right hip joint, femoral surface

    joint, open approach. with metal synthetic

    substitute, open

    approach.

    0SP90BZ.................. Removal of resurfacing and 0SRR039.................. Replacement of right hip

    device from right hip joint, femoral surface

    joint, open approach. with ceramic synthetic

    substitute, cemented,

    open approach.

    0SP90BZ.................. Removal of resurfacing and 0SRR03A.................. Replacement of right hip

    device from right hip joint, femoral surface

    joint, open approach. with ceramic synthetic

    substitute, uncemented,

    open approach.

    0SP90BZ.................. Removal of resurfacing and 0SRR03Z.................. Replacement of right hip

    device from right hip joint, femoral surface

    joint, open approach. with ceramic synthetic

    substitute, open

    approach.

    0SP90BZ.................. Removal of resurfacing and 0SRR0J9.................. Replacement of right hip

    device from right hip joint, femoral surface

    joint, open approach. with synthetic

    substitute, cemented,

    open approach.

    0SP90BZ.................. Removal of resurfacing and 0SRR0JA.................. Replacement of right hip

    device from right hip joint, femoral surface

    joint, open approach. with synthetic

    substitute, uncemented,

    open approach.

    Page 49395

    0SP90BZ.................. Removal of resurfacing and 0SRR0JZ.................. Replacement of right hip

    device from right hip joint, femoral surface

    joint, open approach. with synthetic

    substitute, open

    approach.

    0SP90BZ.................. Removal of resurfacing and 0SU909Z.................. Supplement right hip

    device from right hip joint with liner, open

    joint, open approach. approach.

    0SP90BZ.................. Removal of resurfacing and 0SUA09Z.................. Supplement right hip

    device from right hip joint, acetabular

    joint, open approach. surface with liner,

    open approach.

    0SP90BZ.................. Removal of resurfacing and 0SUR09Z.................. Supplement right hip

    device from right hip joint, femoral surface

    joint, open approach. with liner, open

    approach.

    0SP90JZ.................. Removal of synthetic and 0SR9049.................. Replacement of right hip

    substitute from right joint with ceramic on

    hip joint, open polyethylene synthetic

    approach. substitute, cemented,

    open approach.

    0SP90JZ.................. Removal of synthetic and 0SR904A.................. Replacement of right hip

    substitute from right joint with ceramic on

    hip joint, open polyethylene synthetic

    approach. substitute, uncemented,

    open approach.

    0SP90JZ.................. Removal of synthetic and 0SR904Z.................. Replacement of right hip

    substitute from right joint with ceramic on

    hip joint, open polyethylene synthetic

    approach. substitute, open

    approach.

    0SP948Z.................. Removal of spacer from and 0SR9019.................. Replacement of right hip

    right hip joint, joint with metal

    percutaneous endoscopic synthetic substitute,

    approach. cemented, open

    approach.

    0SP948Z.................. Removal of spacer from and 0SR901A.................. Replacement of right hip

    right hip joint, joint with metal

    percutaneous endoscopic synthetic substitute,

    approach. uncemented, open

    approach.

    0SP948Z.................. Removal of spacer from and 0SR901Z.................. Replacement of right hip

    right hip joint, joint with metal

    percutaneous endoscopic synthetic substitute,

    approach. open approach.

    0SP948Z.................. Removal of spacer from and 0SR9029.................. Replacement of right hip

    right hip joint, joint with metal on

    percutaneous endoscopic polyethylene synthetic

    approach. substitute, cemented,

    open approach.

    0SP948Z.................. Removal of spacer from and 0SR902A.................. Replacement of right hip

    right hip joint, joint with metal on

    percutaneous endoscopic polyethylene synthetic

    approach. substitute, uncemented,

    open approach.

    0SP948Z.................. Removal of spacer from and 0SR902Z.................. Replacement of right hip

    right hip joint, joint with metal on

    percutaneous endoscopic polyethylene synthetic

    approach. substitute, open

    approach.

    0SP948Z.................. Removal of spacer from and 0SR9039.................. Replacement of right hip

    right hip joint, joint with ceramic

    percutaneous endoscopic synthetic substitute,

    approach. cemented, open

    approach.

    0SP948Z.................. Removal of spacer from and 0SR903A.................. Replacement of right hip

    right hip joint, joint with ceramic

    percutaneous endoscopic synthetic substitute,

    approach. uncemented, open

    approach.

    0SP948Z.................. Removal of spacer from and 0SR903Z.................. Replacement of right hip

    right hip joint, joint with ceramic

    percutaneous endoscopic synthetic substitute,

    approach. open approach.

    0SP948Z.................. Removal of spacer from and 0SR9049.................. Replacement of right hip

    right hip joint, joint with ceramic on

    percutaneous endoscopic polyethylene synthetic

    approach. substitute, cemented,

    open approach.

    0SP948Z.................. Removal of spacer from and 0SR904A.................. Replacement of right hip

    right hip joint, joint with ceramic on

    percutaneous endoscopic polyethylene synthetic

    approach. substitute, uncemented,

    open approach.

    0SP948Z.................. Removal of spacer from and 0SR904Z.................. Replacement of right hip

    right hip joint, joint with ceramic on

    percutaneous endoscopic polyethylene synthetic

    approach. substitute, open

    approach.

    0SP948Z.................. Removal of spacer from and 0SR90J9.................. Replacement of right hip

    right hip joint, joint with synthetic

    percutaneous endoscopic substitute, cemented,

    approach. open approach.

    0SP948Z.................. Removal of spacer from and 0SR90JA.................. Replacement of right hip

    right hip joint, joint with synthetic

    percutaneous endoscopic substitute, uncemented,

    approach. open approach.

    0SP948Z.................. Removal of spacer from and 0SR90JZ.................. Replacement of right hip

    right hip joint, joint with synthetic

    percutaneous endoscopic substitute, open

    approach. approach.

    0SP948Z.................. Removal of spacer from and 0SRA009.................. Replacement of right hip

    right hip joint, joint, acetabular

    percutaneous endoscopic surface with

    approach. polyethylene synthetic

    substitute, cemented,

    open approach.

    0SP948Z.................. Removal of spacer from and 0SRA00A.................. Replacement of right hip

    right hip joint, joint, acetabular

    percutaneous endoscopic surface with

    approach. polyethylene synthetic

    substitute, uncemented,

    open approach.

    0SP948Z.................. Removal of spacer from and 0SRA00Z.................. Replacement of right hip

    right hip joint, joint, acetabular

    percutaneous endoscopic surface with

    approach. polyethylene synthetic

    substitute, open

    approach.

    0SP948Z.................. Removal of spacer from and 0SRA019.................. Replacement of right hip

    right hip joint, joint, acetabular

    percutaneous endoscopic surface with metal

    approach. synthetic substitute,

    cemented, open

    approach.

    0SP948Z.................. Removal of spacer from and 0SRA01A.................. Replacement of right hip

    right hip joint, joint, acetabular

    percutaneous endoscopic surface with metal

    approach. synthetic substitute,

    uncemented, open

    approach.

    0SP948Z.................. Removal of spacer from and 0SRA01Z.................. Replacement of right hip

    right hip joint, joint, acetabular

    percutaneous endoscopic surface with metal

    approach. synthetic substitute,

    open approach.

    0SP948Z.................. Removal of spacer from and 0SRA039.................. Replacement of right hip

    right hip joint, joint, acetabular

    percutaneous endoscopic surface with ceramic

    approach. synthetic substitute,

    cemented, open

    approach.

    Page 49396

    0SP948Z.................. Removal of spacer from and 0SRA03A.................. Replacement of right hip

    right hip joint, joint, acetabular

    percutaneous endoscopic surface with ceramic

    approach. synthetic substitute,

    uncemented, open

    approach.

    0SP948Z.................. Removal of spacer from and 0SRA03Z.................. Replacement of right hip

    right hip joint, joint, acetabular

    percutaneous endoscopic surface with ceramic

    approach. synthetic substitute,

    open approach.

    0SP948Z.................. Removal of spacer from and 0SRA0J9.................. Replacement of right hip

    right hip joint, joint, acetabular

    percutaneous endoscopic surface with synthetic

    approach. substitute, cemented,

    open approach.

    0SP948Z.................. Removal of spacer from and 0SRA0JA.................. Replacement of right hip

    right hip joint, joint, acetabular

    percutaneous endoscopic surface with synthetic

    approach. substitute, uncemented,

    open approach.

    0SP948Z.................. Removal of spacer from and 0SRA0JZ.................. Replacement of right hip

    right hip joint, joint, acetabular

    percutaneous endoscopic surface with synthetic

    approach. substitute, open

    approach.

    0SP948Z.................. Removal of spacer from and 0SRR019.................. Replacement of right hip

    right hip joint, joint, femoral surface

    percutaneous endoscopic with metal synthetic

    approach. substitute, cemented,

    open approach.

    0SP948Z.................. Removal of spacer from and 0SRR01A.................. Replacement of right hip

    right hip joint, joint, femoral surface

    percutaneous endoscopic with metal synthetic

    approach. substitute, uncemented,

    open approach.

    0SP948Z.................. Removal of spacer from and 0SRR01Z.................. Replacement of right hip

    right hip joint, joint, femoral surface

    percutaneous endoscopic with metal synthetic

    approach. substitute, open

    approach.

    0SP948Z.................. Removal of spacer from and 0SRR039.................. Replacement of right hip

    right hip joint, joint, femoral surface

    percutaneous endoscopic with ceramic synthetic

    approach. substitute, cemented,

    open approach.

    0SP948Z.................. Removal of spacer from and 0SRR03A.................. Replacement of right hip

    right hip joint, joint, femoral surface

    percutaneous endoscopic with ceramic synthetic

    approach. substitute, uncemented,

    open approach.

    0SP948Z.................. Removal of spacer from and 0SRR03Z.................. Replacement of right hip

    right hip joint, joint, femoral surface

    percutaneous endoscopic with ceramic synthetic

    approach. substitute, open

    approach.

    0SP948Z.................. Removal of spacer from and 0SRR0J9.................. Replacement of right hip

    right hip joint, joint, femoral surface

    percutaneous endoscopic with synthetic

    approach. substitute, cemented,

    open approach.

    0SP948Z.................. Removal of spacer from and 0SRR0JA.................. Replacement of right hip

    right hip joint, joint, femoral surface

    percutaneous endoscopic with synthetic

    approach. substitute, uncemented,

    open approach.

    0SP948Z.................. Removal of spacer from and 0SRR0JZ.................. Replacement of right hip

    right hip joint, joint, femoral surface

    percutaneous endoscopic with synthetic

    approach. substitute, open

    approach.

    0SP948Z.................. Removal of spacer from and 0SU909Z.................. Supplement right hip

    right hip joint, joint with liner, open

    percutaneous endoscopic approach.

    approach.

    0SP948Z.................. Removal of spacer from and 0SUA09Z.................. Supplement right hip

    right hip joint, joint, acetabular

    percutaneous endoscopic surface with liner,

    approach. open approach.

    0SP948Z.................. Removal of spacer from and 0SUR09Z.................. Supplement right hip

    right hip joint, joint, femoral surface

    percutaneous endoscopic with liner, open

    approach. approach.

    0SP94JZ.................. Removal of synthetic and 0SR9019.................. Replacement of right hip

    substitute from right joint with metal

    hip joint, percutaneous synthetic substitute,

    endoscopic approach. cemented, open

    approach.

    0SP94JZ.................. Removal of synthetic and 0SR901A.................. Replacement of right hip

    substitute from right joint with metal

    hip joint, percutaneous synthetic substitute,

    endoscopic approach. uncemented, open

    approach.

    0SP94JZ.................. Removal of synthetic and 0SR901Z.................. Replacement of right hip

    substitute from right joint with metal

    hip joint, percutaneous synthetic substitute,

    endoscopic approach. open approach.

    0SP94JZ.................. Removal of synthetic and 0SR9029.................. Replacement of right hip

    substitute from right joint with metal on

    hip joint, percutaneous polyethylene synthetic

    endoscopic approach. substitute, cemented,

    open approach.

    0SP94JZ.................. Removal of synthetic and 0SR902A.................. Replacement of right hip

    substitute from right joint with metal on

    hip joint, percutaneous polyethylene synthetic

    endoscopic approach. substitute, uncemented,

    open approach.

    0SP94JZ.................. Removal of synthetic and 0SR902Z.................. Replacement of right hip

    substitute from right joint with metal on

    hip joint, percutaneous polyethylene synthetic

    endoscopic approach. substitute, open

    approach.

    0SP94JZ.................. Removal of synthetic and 0SR9039.................. Replacement of right hip

    substitute from right joint with ceramic

    hip joint, percutaneous synthetic substitute,

    endoscopic approach. cemented, open

    approach.

    0SP94JZ.................. Removal of synthetic and 0SR903A.................. Replacement of right hip

    substitute from right joint with ceramic

    hip joint, percutaneous synthetic substitute,

    endoscopic approach. uncemented, open

    approach.

    0SP94JZ.................. Removal of synthetic and 0SR903Z.................. Replacement of right hip

    substitute from right joint with ceramic

    hip joint, percutaneous synthetic substitute,

    endoscopic approach. open approach.

    0SP94JZ.................. Removal of synthetic and 0SR9049.................. Replacement of right hip

    substitute from right joint with ceramic on

    hip joint, percutaneous polyethylene synthetic

    endoscopic approach. substitute, cemented,

    open approach.

    0SP94JZ.................. Removal of synthetic and 0SR904A.................. Replacement of right hip

    substitute from right joint with ceramic on

    hip joint, percutaneous polyethylene synthetic

    endoscopic approach. substitute, uncemented,

    open approach.

    Page 49397

    0SP94JZ.................. Removal of synthetic and 0SR904Z.................. Replacement of right hip

    substitute from right joint with ceramic on

    hip joint, percutaneous polyethylene synthetic

    endoscopic approach. substitute, open

    approach.

    0SP94JZ.................. Removal of synthetic and 0SR90J9.................. Replacement of right hip

    substitute from right joint with synthetic

    hip joint, percutaneous substitute, cemented,

    endoscopic approach. open approach.

    0SP94JZ.................. Removal of synthetic and 0SR90JA.................. Replacement of right hip

    substitute from right joint with synthetic

    hip joint, percutaneous substitute, uncemented,

    endoscopic approach. open approach.

    0SP94JZ.................. Removal of synthetic and 0SR90JZ.................. Replacement of right hip

    substitute from right joint with synthetic

    hip joint, percutaneous substitute, open

    endoscopic approach. approach.

    0SP94JZ.................. Removal of synthetic and 0SRA009.................. Replacement of right hip

    substitute from right joint, acetabular

    hip joint, percutaneous surface with

    endoscopic approach. polyethylene synthetic

    substitute, cemented,

    open approach.

    0SP94JZ.................. Removal of synthetic and 0SRA00A.................. Replacement of right hip

    substitute from right joint, acetabular

    hip joint, percutaneous surface with

    endoscopic approach. polyethylene synthetic

    substitute, uncemented,

    open approach.

    0SP94JZ.................. Removal of synthetic and 0SRA00Z.................. Replacement of right hip

    substitute from right joint, acetabular

    hip joint, percutaneous surface with

    endoscopic approach. polyethylene synthetic

    substitute, open

    approach.

    0SP94JZ.................. Removal of synthetic and 0SRA019.................. Replacement of right hip

    substitute from right joint, acetabular

    hip joint, percutaneous surface with metal

    endoscopic approach. synthetic substitute,

    cemented, open

    approach.

    0SP94JZ.................. Removal of synthetic and 0SRA01A.................. Replacement of right hip

    substitute from right joint, acetabular

    hip joint, percutaneous surface with metal

    endoscopic approach. synthetic substitute,

    uncemented, open

    approach.

    0SP94JZ.................. Removal of synthetic and 0SRA01Z.................. Replacement of right hip

    substitute from right joint, acetabular

    hip joint, percutaneous surface with metal

    endoscopic approach. synthetic substitute,

    open approach.

    0SP94JZ.................. Removal of synthetic and 0SRA039.................. Replacement of right hip

    substitute from right joint, acetabular

    hip joint, percutaneous surface with ceramic

    endoscopic approach. synthetic substitute,

    cemented, open

    approach.

    0SP94JZ.................. Removal of synthetic and 0SRA03A.................. Replacement of right hip

    substitute from right joint, acetabular

    hip joint, percutaneous surface with ceramic

    endoscopic approach. synthetic substitute,

    uncemented, open

    approach.

    0SP94JZ.................. Removal of synthetic and 0SRA03Z.................. Replacement of right hip

    substitute from right joint, acetabular

    hip joint, percutaneous surface with ceramic

    endoscopic approach. synthetic substitute,

    open approach.

    0SP94JZ.................. Removal of synthetic and 0SRA0J9.................. Replacement of right hip

    substitute from right joint, acetabular

    hip joint, percutaneous surface with synthetic

    endoscopic approach. substitute, cemented,

    open approach.

    0SP94JZ.................. Removal of synthetic and 0SRA0JA.................. Replacement of right hip

    substitute from right joint, acetabular

    hip joint, percutaneous surface with synthetic

    endoscopic approach. substitute, uncemented,

    open approach.

    0SP94JZ.................. Removal of synthetic and 0SRA0JZ.................. Replacement of right hip

    substitute from right joint, acetabular

    hip joint, percutaneous surface with synthetic

    endoscopic approach. substitute, open

    approach.

    0SP94JZ.................. Removal of synthetic and 0SRR019.................. Replacement of right hip

    substitute from right joint, femoral surface

    hip joint, percutaneous with metal synthetic

    endoscopic approach. substitute, cemented,

    open approach.

    0SP94JZ.................. Removal of synthetic and 0SRR01A.................. Replacement of right hip

    substitute from right joint, femoral surface

    hip joint, percutaneous with metal synthetic

    endoscopic approach. substitute, uncemented,

    open approach.

    0SP94JZ.................. Removal of synthetic and 0SRR01Z.................. Replacement of right hip

    substitute from right joint, femoral surface

    hip joint, percutaneous with metal synthetic

    endoscopic approach. substitute, open

    approach.

    0SP94JZ.................. Removal of synthetic and 0SRR039.................. Replacement of right hip

    substitute from right joint, femoral surface

    hip joint, percutaneous with ceramic synthetic

    endoscopic approach. substitute, cemented,

    open approach.

    0SP94JZ.................. Removal of synthetic and 0SRR03A.................. Replacement of right hip

    substitute from right joint, femoral surface

    hip joint, percutaneous with ceramic synthetic

    endoscopic approach. substitute, uncemented,

    open approach.

    0SP94JZ.................. Removal of synthetic and 0SRR03Z.................. Replacement of right hip

    substitute from right joint, femoral surface

    hip joint, percutaneous with ceramic synthetic

    endoscopic approach. substitute, open

    approach.

    0SP94JZ.................. Removal of synthetic and 0SRR0J9.................. Replacement of right hip

    substitute from right joint, femoral surface

    hip joint, percutaneous with synthetic

    endoscopic approach. substitute, cemented,

    open approach.

    0SP94JZ.................. Removal of synthetic and 0SRR0JA.................. Replacement of right hip

    substitute from right joint, femoral surface

    hip joint, percutaneous with synthetic

    endoscopic approach. substitute, uncemented,

    open approach.

    0SP94JZ.................. Removal of synthetic and 0SRR0JZ.................. Replacement of right hip

    substitute from right joint, femoral surface

    hip joint, percutaneous with synthetic

    endoscopic approach. substitute, open

    approach.

    0SP94JZ.................. Removal of synthetic and 0SU909Z.................. Supplement right hip

    substitute from right joint with liner, open

    hip joint, percutaneous approach.

    endoscopic approach.

    0SP94JZ.................. Removal of synthetic and 0SUA09Z.................. Supplement right hip

    substitute from right joint, acetabular

    hip joint, percutaneous surface with liner,

    endoscopic approach. open approach.

    Page 49398

    0SP94JZ.................. Removal of synthetic and 0SUR09Z.................. Supplement right hip

    substitute from right joint, femoral surface

    hip joint, percutaneous with liner, open

    endoscopic approach. approach.

    0SPB08Z.................. Removal of spacer from and 0SRB019.................. Replacement of left hip

    left hip joint, open joint with metal

    approach. synthetic substitute,

    cemented, open

    approach.

    0SPB08Z.................. Removal of spacer from and 0SRB01A.................. Replacement of left hip

    left hip joint, open joint with metal

    approach. synthetic substitute,

    uncemented, open

    approach.

    0SPB08Z.................. Removal of spacer from and 0SRB01Z.................. Replacement of left hip

    left hip joint, open joint with metal

    approach. synthetic substitute,

    open approach.

    0SPB08Z.................. Removal of spacer from and 0SRB029.................. Replacement of left hip

    left hip joint, open joint with metal on

    approach. polyethylene synthetic

    substitute, cemented,

    open approach.

    0SPB08Z.................. Removal of spacer from and 0SRB02A.................. Replacement of left hip

    left hip joint, open joint with metal on

    approach. polyethylene synthetic

    substitute, uncemented,

    open approach.

    0SPB08Z.................. Removal of spacer from and 0SRB02Z.................. Replacement of left hip

    left hip joint, open joint with metal on

    approach. polyethylene synthetic

    substitute, open

    approach.

    0SPB08Z.................. Removal of spacer from and 0SRB039.................. Replacement of left hip

    left hip joint, open joint with ceramic

    approach. synthetic substitute,

    cemented, open

    approach.

    0SPB08Z.................. Removal of spacer from and 0SRB03A.................. Replacement of left hip

    left hip joint, open joint with ceramic

    approach. synthetic substitute,

    uncemented, open

    approach.

    0SPB08Z.................. Removal of spacer from and 0SRB03Z.................. Replacement of left hip

    left hip joint, open joint with ceramic

    approach. synthetic substitute,

    open approach.

    0SPB08Z.................. Removal of spacer from and 0SRB049.................. Replacement of left hip

    left hip joint, open joint with ceramic on

    approach. polyethylene synthetic

    substitute, cemented,

    open approach.

    0SPB08Z.................. Removal of spacer from and 0SRB04A.................. Replacement of left hip

    left hip joint, open joint with ceramic on

    approach. polyethylene synthetic

    substitute, uncemented,

    open approach.

    0SPB08Z.................. Removal of spacer from and 0SRB04Z.................. Replacement of left hip

    left hip joint, open joint with ceramic on

    approach. polyethylene synthetic

    substitute, open

    approach.

    0SPB08Z.................. Removal of spacer from and 0SRB0J9.................. Replacement of left hip

    left hip joint, open joint with synthetic

    approach. substitute, cemented,

    open approach.

    0SPB08Z.................. Removal of spacer from and 0SRB0JA.................. Replacement of left hip

    left hip joint, open joint with synthetic

    approach. substitute, uncemented,

    open approach.

    0SPB08Z.................. Removal of spacer from and 0SRB0JZ.................. Replacement of left hip

    left hip joint, open joint with synthetic

    approach. substitute, open

    approach.

    0SPB08Z.................. Removal of spacer from and 0SRE009.................. Replacement of left hip

    left hip joint, open joint, acetabular

    approach. surface with

    polyethylene synthetic

    substitute, cemented,

    open approach.

    0SPB08Z.................. Removal of spacer from and 0SRE00A.................. Replacement of left hip

    left hip joint, open joint, acetabular

    approach. surface with

    polyethylene synthetic

    substitute, uncemented,

    open approach.

    0SPB08Z.................. Removal of spacer from and 0SRE00Z.................. Replacement of left hip

    left hip joint, open joint, acetabular

    approach. surface with

    polyethylene synthetic

    substitute, open

    approach.

    0SPB08Z.................. Removal of spacer from and 0SRE019.................. Replacement of left hip

    left hip joint, open joint, acetabular

    approach. surface with metal

    synthetic substitute,

    cemented, open

    approach.

    0SPB08Z.................. Removal of spacer from and 0SRE01A.................. Replacement of left hip

    left hip joint, open joint, acetabular

    approach. surface with metal

    synthetic substitute,

    uncemented, open

    approach.

    0SPB08Z.................. Removal of spacer from and 0SRE01Z.................. Replacement of left hip

    left hip joint, open joint, acetabular

    approach. surface with metal

    synthetic substitute,

    open approach.

    0SPB08Z.................. Removal of spacer from and 0SRE039.................. Replacement of left hip

    left hip joint, open joint, acetabular

    approach. surface with ceramic

    synthetic substitute,

    cemented, open

    approach.

    0SPB08Z.................. Removal of spacer from and 0SRE03A.................. Replacement of left hip

    left hip joint, open joint, acetabular

    approach. surface with ceramic

    synthetic substitute,

    uncemented, open

    approach.

    0SPB08Z.................. Removal of spacer from and 0SRE03Z.................. Replacement of left hip

    left hip joint, open joint, acetabular

    approach. surface with ceramic

    synthetic substitute,

    open approach.

    0SPB08Z.................. Removal of spacer from and 0SRE0J9.................. Replacement of left hip

    left hip joint, open joint, acetabular

    approach. surface with synthetic

    substitute, cemented,

    open approach.

    0SPB08Z.................. Removal of spacer from and 0SRE0JA.................. Replacement of left hip

    left hip joint, open joint, acetabular

    approach. surface with synthetic

    substitute, uncemented,

    open approach.

    0SPB08Z.................. Removal of spacer from and 0SRE0JZ.................. Replacement of left hip

    left hip joint, open joint, acetabular

    approach. surface with synthetic

    substitute, open

    approach.

    Page 49399

    0SPB08Z.................. Removal of spacer from and 0SRS019.................. Replacement of left hip

    left hip joint, open joint, femoral surface

    approach. with metal synthetic

    substitute, cemented,

    open approach.

    0SPB08Z.................. Removal of spacer from and 0SRS01A.................. Replacement of left hip

    left hip joint, open joint, femoral surface

    approach. with metal synthetic

    substitute, uncemented,

    open approach.

    0SPB08Z.................. Removal of spacer from and 0SRS01Z.................. Replacement of left hip

    left hip joint, open joint, femoral surface

    approach. with metal synthetic

    substitute, open

    approach.

    0SPB08Z.................. Removal of spacer from and 0SRS039.................. Replacement of left hip

    left hip joint, open joint, femoral surface

    approach. with ceramic synthetic

    substitute, cemented,

    open approach.

    0SPB08Z.................. Removal of spacer from and 0SRS03A.................. Replacement of left hip

    left hip joint, open joint, femoral surface

    approach. with ceramic synthetic

    substitute, uncemented,

    open approach.

    0SPB08Z.................. Removal of spacer from and 0SRS03Z.................. Replacement of left hip

    left hip joint, open joint, femoral surface

    approach. with ceramic synthetic

    substitute, open

    approach.

    0SPB08Z.................. Removal of spacer from and 0SRS0J9.................. Replacement of left hip

    left hip joint, open joint, femoral surface

    approach. with synthetic

    substitute, cemented,

    open approach.

    0SPB08Z.................. Removal of spacer from and 0SRS0JA.................. Replacement of left hip

    left hip joint, open joint, femoral surface

    approach. with synthetic

    substitute, uncemented,

    open approach.

    0SPB08Z.................. Removal of spacer from and 0SRS0JZ.................. Replacement of left hip

    left hip joint, open joint, femoral surface

    approach. with synthetic

    substitute, open

    approach.

    0SPB08Z.................. Removal of spacer from and 0SUB09Z.................. Supplement left hip

    left hip joint, open joint with liner, open

    approach. approach.

    0SPB08Z.................. Removal of spacer from and 0SUE09Z.................. Supplement left hip

    left hip joint, open joint, acetabular

    approach. surface with liner,

    open approach.

    0SPB08Z.................. Removal of spacer from and 0SUS09Z.................. Supplement left hip

    left hip joint, open joint, femoral surface

    approach. with liner, open

    approach.

    0SPB09Z.................. Removal of liner from and 0SRB019.................. Replacement of left hip

    left hip joint, open joint with metal

    approach. synthetic substitute,

    cemented, open

    approach.

    0SPB09Z.................. Removal of liner from and 0SRB01A.................. Replacement of left hip

    left hip joint, open joint with metal

    approach. synthetic substitute,

    uncemented, open

    approach.

    0SPB09Z.................. Removal of liner from and 0SRB01Z.................. Replacement of left hip

    left hip joint, open joint with metal

    approach. synthetic substitute,

    open approach.

    0SPB09Z.................. Removal of liner from and 0SRB029.................. Replacement of left hip

    left hip joint, open joint with metal on

    approach. polyethylene synthetic

    substitute, cemented,

    open approach.

    0SPB09Z.................. Removal of liner from and 0SRB02A.................. Replacement of left hip

    left hip joint, open joint with metal on

    approach. polyethylene synthetic

    substitute, uncemented,

    open approach.

    0SPB09Z.................. Removal of liner from and 0SRB02Z.................. Replacement of left hip

    left hip joint, open joint with metal on

    approach. polyethylene synthetic

    substitute, open

    approach.

    0SPB09Z.................. Removal of liner from and 0SRB039.................. Replacement of left hip

    left hip joint, open joint with ceramic

    approach. synthetic substitute,

    cemented, open

    approach.

    0SPB09Z.................. Removal of liner from and 0SRB03A.................. Replacement of left hip

    left hip joint, open joint with ceramic

    approach. synthetic substitute,

    uncemented, open

    approach.

    0SPB09Z.................. Removal of liner from and 0SRB03Z.................. Replacement of left hip

    left hip joint, open joint with ceramic

    approach. synthetic substitute,

    open approach.

    0SPB09Z.................. Removal of liner from and 0SRB049.................. Replacement of left hip

    left hip joint, open joint with ceramic on

    approach. polyethylene synthetic

    substitute, cemented,

    open approach.

    0SPB09Z.................. Removal of liner from and 0SRB04A.................. Replacement of left hip

    left hip joint, open joint with ceramic on

    approach. polyethylene synthetic

    substitute, uncemented,

    open approach.

    0SPB09Z.................. Removal of liner from and 0SRB04Z.................. Replacement of left hip

    left hip joint, open joint with ceramic on

    approach. polyethylene synthetic

    substitute, open

    approach.

    0SPB09Z.................. Removal of liner from and 0SRB0J9.................. Replacement of left hip

    left hip joint, open joint with synthetic

    approach. substitute, cemented,

    open approach.

    0SPB09Z.................. Removal of liner from and 0SRB0JA.................. Replacement of left hip

    left hip joint, open joint with synthetic

    approach. substitute, uncemented,

    open approach.

    0SPB09Z.................. Removal of liner from and 0SRB0JZ.................. Replacement of left hip

    left hip joint, open joint with synthetic

    approach. substitute, open

    approach.

    0SPB09Z.................. Removal of liner from and 0SRE009.................. Replacement of left hip

    left hip joint, open joint, acetabular

    approach. surface with

    polyethylene synthetic

    substitute, cemented,

    open approach.

    0SPB09Z.................. Removal of liner from and 0SRE00A.................. Replacement of left hip

    left hip joint, open joint, acetabular

    approach. surface with

    polyethylene synthetic

    substitute, uncemented,

    open approach.

    Page 49400

    0SPB09Z.................. Removal of liner from and 0SRE00Z.................. Replacement of left hip

    left hip joint, open joint, acetabular

    approach. surface with

    polyethylene synthetic

    substitute, open

    approach.

    0SPB09Z.................. Removal of liner from and 0SRE019.................. Replacement of left hip

    left hip joint, open joint, acetabular

    approach. surface with metal

    synthetic substitute,

    cemented, open

    approach.

    0SPB09Z.................. Removal of liner from and 0SRE01A.................. Replacement of left hip

    left hip joint, open joint, acetabular

    approach. surface with metal

    synthetic substitute,

    uncemented, open

    approach.

    0SPB09Z.................. Removal of liner from and 0SRE01Z.................. Replacement of left hip

    left hip joint, open joint, acetabular

    approach. surface with metal

    synthetic substitute,

    open approach.

    0SPB09Z.................. Removal of liner from and 0SRE039.................. Replacement of left hip

    left hip joint, open joint, acetabular

    approach. surface with ceramic

    synthetic substitute,

    cemented, open

    approach.

    0SPB09Z.................. Removal of liner from and 0SRE03A.................. Replacement of left hip

    left hip joint, open joint, acetabular

    approach. surface with ceramic

    synthetic substitute,

    uncemented, open

    approach.

    0SPB09Z.................. Removal of liner from and 0SRE03Z.................. Replacement of left hip

    left hip joint, open joint, acetabular

    approach. surface with ceramic

    synthetic substitute,

    open approach.

    0SPB09Z.................. Removal of liner from and 0SRE0J9.................. Replacement of left hip

    left hip joint, open joint, acetabular

    approach. surface with synthetic

    substitute, cemented,

    open approach.

    0SPB09Z.................. Removal of liner from and 0SRE0JA.................. Replacement of left hip

    left hip joint, open joint, acetabular

    approach. surface with synthetic

    substitute, uncemented,

    open approach.

    0SPB09Z.................. Removal of liner from and 0SRE0JZ.................. Replacement of left hip

    left hip joint, open joint, acetabular

    approach. surface with synthetic

    substitute, open

    approach.

    0SPB09Z.................. Removal of liner from and 0SRS019.................. Replacement of left hip

    left hip joint, open joint, femoral surface

    approach. with metal synthetic

    substitute, cemented,

    open approach.

    0SPB09Z.................. Removal of liner from and 0SRS01A.................. Replacement of left hip

    left hip joint, open joint, femoral surface

    approach. with metal synthetic

    substitute, uncemented,

    open approach.

    0SPB09Z.................. Removal of liner from and 0SRS01Z.................. Replacement of left hip

    left hip joint, open joint, femoral surface

    approach. with metal synthetic

    substitute, open

    approach.

    0SPB09Z.................. Removal of liner from and 0SRS039.................. Replacement of left hip

    left hip joint, open joint, femoral surface

    approach. with ceramic synthetic

    substitute, cemented,

    open approach.

    0SPB09Z.................. Removal of liner from and 0SRS03A.................. Replacement of left hip

    left hip joint, open joint, femoral surface

    approach. with ceramic synthetic

    substitute, uncemented,

    open approach.

    0SPB09Z.................. Removal of liner from and 0SRS03Z.................. Replacement of left hip

    left hip joint, open joint, femoral surface

    approach. with ceramic synthetic

    substitute, open

    approach.

    0SPB09Z.................. Removal of liner from and 0SRS0J9.................. Replacement of left hip

    left hip joint, open joint, femoral surface

    approach. with synthetic

    substitute, cemented,

    open approach.

    0SPB09Z.................. Removal of liner from and 0SRS0JA.................. Replacement of left hip

    left hip joint, open joint, femoral surface

    approach. with synthetic

    substitute, uncemented,

    open approach.

    0SPB09Z.................. Removal of liner from and 0SRS0JZ.................. Replacement of left hip

    left hip joint, open joint, femoral surface

    approach. with synthetic

    substitute, open

    approach.

    0SPB09Z.................. Removal of liner from and 0SUB09Z.................. Supplement left hip

    left hip joint, open joint with liner, open

    approach. approach.

    0SPB09Z.................. Removal of liner from and 0SUE09Z.................. Supplement left hip

    left hip joint, open joint, acetabular

    approach. surface with liner,

    open approach.

    0SPB09Z.................. Removal of liner from and 0SUS09Z.................. Supplement left hip

    left hip joint, open joint, femoral surface

    approach. with liner, open

    approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRB019.................. Replacement of left hip

    device from left hip joint with metal

    joint, open approach. synthetic substitute,

    cemented, open

    approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRB01A.................. Replacement of left hip

    device from left hip joint with metal

    joint, open approach. synthetic substitute,

    uncemented, open

    approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRB01Z.................. Replacement of left hip

    device from left hip joint with metal

    joint, open approach. synthetic substitute,

    open approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRB029.................. Replacement of left hip

    device from left hip joint with metal on

    joint, open approach. polyethylene synthetic

    substitute, cemented,

    open approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRB02A.................. Replacement of left hip

    device from left hip joint with metal on

    joint, open approach. polyethylene synthetic

    substitute, uncemented,

    open approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRB02Z.................. Replacement of left hip

    device from left hip joint with metal on

    joint, open approach. polyethylene synthetic

    substitute, open

    approach.

    Page 49401

    0SPB0BZ.................. Removal of resurfacing and 0SRB039.................. Replacement of left hip

    device from left hip joint with ceramic

    joint, open approach. synthetic substitute,

    cemented, open

    approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRB03A.................. Replacement of left hip

    device from left hip joint with ceramic

    joint, open approach. synthetic substitute,

    uncemented, open

    approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRB03Z.................. Replacement of left hip

    device from left hip joint with ceramic

    joint, open approach. synthetic substitute,

    open approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRB049.................. Replacement of left hip

    device from left hip joint with ceramic on

    joint, open approach. polyethylene synthetic

    substitute, cemented,

    open approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRB04A.................. Replacement of left hip

    device from left hip joint with ceramic on

    joint, open approach. polyethylene synthetic

    substitute, uncemented,

    open approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRB04Z.................. Replacement of left hip

    device from left hip joint with ceramic on

    joint, open approach. polyethylene synthetic

    substitute, open

    approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRB0J9.................. Replacement of left hip

    device from left hip joint with synthetic

    joint, open approach. substitute, cemented,

    open approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRB0JA.................. Replacement of left hip

    device from left hip joint with synthetic

    joint, open approach. substitute, uncemented,

    open approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRB0JZ.................. Replacement of left hip

    device from left hip joint with synthetic

    joint, open approach. substitute, open

    approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRE009.................. Replacement of left hip

    device from left hip joint, acetabular

    joint, open approach. surface with

    polyethylene synthetic

    substitute, cemented,

    open approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRE00A.................. Replacement of left hip

    device from left hip joint, acetabular

    joint, open approach. surface with

    polyethylene synthetic

    substitute, uncemented,

    open approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRE00Z.................. Replacement of left hip

    device from left hip joint, acetabular

    joint, open approach. surface with

    polyethylene synthetic

    substitute, open

    approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRE019.................. Replacement of left hip

    device from left hip joint, acetabular

    joint, open approach. surface with metal

    synthetic substitute,

    cemented, open

    approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRE01A.................. Replacement of left hip

    device from left hip joint, acetabular

    joint, open approach. surface with metal

    synthetic substitute,

    uncemented, open

    approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRE01Z.................. Replacement of left hip

    device from left hip joint, acetabular

    joint, open approach. surface with metal

    synthetic substitute,

    open approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRE039.................. Replacement of left hip

    device from left hip joint, acetabular

    joint, open approach. surface with ceramic

    synthetic substitute,

    cemented, open

    approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRE03A.................. Replacement of left hip

    device from left hip joint, acetabular

    joint, open approach. surface with ceramic

    synthetic substitute,

    uncemented, open

    approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRE03Z.................. Replacement of left hip

    device from left hip joint, acetabular

    joint, open approach. surface with ceramic

    synthetic substitute,

    open approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRE0J9.................. Replacement of left hip

    device from left hip joint, acetabular

    joint, open approach. surface with synthetic

    substitute, cemented,

    open approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRE0JA.................. Replacement of left hip

    device from left hip joint, acetabular

    joint, open approach. surface with synthetic

    substitute, uncemented,

    open approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRE0JZ.................. Replacement of left hip

    device from left hip joint, acetabular

    joint, open approach. surface with synthetic

    substitute, open

    approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRS019.................. Replacement of left hip

    device from left hip joint, femoral surface

    joint, open approach. with metal synthetic

    substitute, cemented,

    open approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRS01A.................. Replacement of left hip

    device from left hip joint, femoral surface

    joint, open approach. with metal synthetic

    substitute, uncemented,

    open approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRS01Z.................. Replacement of left hip

    device from left hip joint, femoral surface

    joint, open approach. with metal synthetic

    substitute, open

    approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRS039.................. Replacement of left hip

    device from left hip joint, femoral surface

    joint, open approach. with ceramic synthetic

    substitute, cemented,

    open approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRS03A.................. Replacement of left hip

    device from left hip joint, femoral surface

    joint, open approach. with ceramic synthetic

    substitute, uncemented,

    open approach.

    Page 49402

    0SPB0BZ.................. Removal of resurfacing and 0SRS03Z.................. Replacement of left hip

    device from left hip joint, femoral surface

    joint, open approach. with ceramic synthetic

    substitute, open

    approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRS0J9.................. Replacement of left hip

    device from left hip joint, femoral surface

    joint, open approach. with synthetic

    substitute, cemented,

    open approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRS0JA.................. Replacement of left hip

    device from left hip joint, femoral surface

    joint, open approach. with synthetic

    substitute, uncemented,

    open approach.

    0SPB0BZ.................. Removal of resurfacing and 0SRS0JZ.................. Replacement of left hip

    device from left hip joint, femoral surface

    joint, open approach. with synthetic

    substitute, open

    approach.

    0SPB0BZ.................. Removal of resurfacing and 0SUB09Z.................. Supplement left hip

    device from left hip joint with liner, open

    joint, open approach. approach.

    0SPB0BZ.................. Removal of resurfacing and 0SUE09Z.................. Supplement left hip

    device from left hip joint, acetabular

    joint, open approach. surface with liner,

    open approach.

    0SPB0BZ.................. Removal of resurfacing and 0SUS09Z.................. Supplement left hip

    device from left hip joint, femoral surface

    joint, open approach. with liner, open

    approach.

    0SPB0JZ.................. Removal of synthetic and 0SRB049.................. Replacement of left hip

    substitute from left joint with ceramic on

    hip joint, open polyethylene synthetic

    approach. substitute, cemented,

    open approach.

    0SPB0JZ.................. Removal of synthetic and 0SRB04A.................. Replacement of left hip

    substitute from left joint with ceramic on

    hip joint, open polyethylene synthetic

    approach. substitute, uncemented,

    open approach.

    0SPB0JZ.................. Removal of synthetic and 0SRB04Z.................. Replacement of left hip

    substitute from left joint with ceramic on

    hip joint, open polyethylene synthetic

    approach. substitute, open

    approach.

    0SPB48Z.................. Removal of spacer from and 0SRB019.................. Replacement of left hip

    left hip joint, joint with metal

    percutaneous endoscopic synthetic substitute,

    approach. cemented, open

    approach.

    0SPB48Z.................. Removal of spacer from and 0SRB01A.................. Replacement of left hip

    left hip joint, joint with metal

    percutaneous endoscopic synthetic substitute,

    approach. uncemented, open

    approach.

    0SPB48Z.................. Removal of spacer from and 0SRB01Z.................. Replacement of left hip

    left hip joint, joint with metal

    percutaneous endoscopic synthetic substitute,

    approach. open approach.

    0SPB48Z.................. Removal of spacer from and 0SRB029.................. Replacement of left hip

    left hip joint, joint with metal on

    percutaneous endoscopic polyethylene synthetic

    approach. substitute, cemented,

    open approach.

    0SPB48Z.................. Removal of spacer from and 0SRB02A.................. Replacement of left hip

    left hip joint, joint with metal on

    percutaneous endoscopic polyethylene synthetic

    approach. substitute, uncemented,

    open approach.

    0SPB48Z.................. Removal of spacer from and 0SRB02Z.................. Replacement of left hip

    left hip joint, joint with metal on

    percutaneous endoscopic polyethylene synthetic

    approach. substitute, open

    approach.

    0SPB48Z.................. Removal of spacer from and 0SRB039.................. Replacement of left hip

    left hip joint, joint with ceramic

    percutaneous endoscopic synthetic substitute,

    approach. cemented, open

    approach.

    0SPB48Z.................. Removal of spacer from and 0SRB03A.................. Replacement of left hip

    left hip joint, joint with ceramic

    percutaneous endoscopic synthetic substitute,

    approach. uncemented, open

    approach.

    0SPB48Z.................. Removal of spacer from and 0SRB03Z.................. Replacement of left hip

    left hip joint, joint with ceramic

    percutaneous endoscopic synthetic substitute,

    approach. open approach.

    0SPB48Z.................. Removal of spacer from and 0SRB049.................. Replacement of left hip

    left hip joint, joint with ceramic on

    percutaneous endoscopic polyethylene synthetic

    approach. substitute, cemented,

    open approach.

    0SPB48Z.................. Removal of spacer from and 0SRB04A.................. Replacement of left hip

    left hip joint, joint with ceramic on

    percutaneous endoscopic polyethylene synthetic

    approach. substitute, uncemented,

    open approach.

    0SPB48Z.................. Removal of spacer from and 0SRB04Z.................. Replacement of left hip

    left hip joint, joint with ceramic on

    percutaneous endoscopic polyethylene synthetic

    approach. substitute, open

    approach.

    0SPB48Z.................. Removal of spacer from and 0SRB0J9.................. Replacement of left hip

    left hip joint, joint with synthetic

    percutaneous endoscopic substitute, cemented,

    approach. open approach.

    0SPB48Z.................. Removal of spacer from and 0SRB0JA.................. Replacement of left hip

    left hip joint, joint with synthetic

    percutaneous endoscopic substitute, uncemented,

    approach. open approach.

    0SPB48Z.................. Removal of spacer from and 0SRB0JZ.................. Replacement of left hip

    left hip joint, joint with synthetic

    percutaneous endoscopic substitute, open

    approach. approach.

    0SPB48Z.................. Removal of spacer from and 0SRE009.................. Replacement of left hip

    left hip joint, joint, acetabular

    percutaneous endoscopic surface with

    approach. polyethylene synthetic

    substitute, cemented,

    open approach.

    0SPB48Z.................. Removal of spacer from and 0SRE00A.................. Replacement of left hip

    left hip joint, joint, acetabular

    percutaneous endoscopic surface with

    approach. polyethylene synthetic

    substitute, uncemented,

    open approach.

    0SPB48Z.................. Removal of spacer from and 0SRE00Z.................. Replacement of left hip

    left hip joint, joint, acetabular

    percutaneous endoscopic surface with

    approach. polyethylene synthetic

    substitute, open

    approach.

    0SPB48Z.................. Removal of spacer from and 0SRE019.................. Replacement of left hip

    left hip joint, joint, acetabular

    percutaneous endoscopic surface with metal

    approach. synthetic substitute,

    cemented, open

    approach.

    Page 49403

    0SPB48Z.................. Removal of spacer from and 0SRE01A.................. Replacement of left hip

    left hip joint, joint, acetabular

    percutaneous endoscopic surface with metal

    approach. synthetic substitute,

    uncemented, open

    approach.

    0SPB48Z.................. Removal of spacer from and 0SRE01Z.................. Replacement of left hip

    left hip joint, joint, acetabular

    percutaneous endoscopic surface with metal

    approach. synthetic substitute,

    open approach.

    0SPB48Z.................. Removal of spacer from and 0SRE039.................. Replacement of left hip

    left hip joint, joint, acetabular

    percutaneous endoscopic surface with ceramic

    approach. synthetic substitute,

    cemented, open

    approach.

    0SPB48Z.................. Removal of spacer from and 0SRE03A.................. Replacement of left hip

    left hip joint, joint, acetabular

    percutaneous endoscopic surface with ceramic

    approach. synthetic substitute,

    uncemented, open

    approach.

    0SPB48Z.................. Removal of spacer from and 0SRE03Z.................. Replacement of left hip

    left hip joint, joint, acetabular

    percutaneous endoscopic surface with ceramic

    approach. synthetic substitute,

    open approach.

    0SPB48Z.................. Removal of spacer from and 0SRE0J9.................. Replacement of left hip

    left hip joint, joint, acetabular

    percutaneous endoscopic surface with synthetic

    approach. substitute, cemented,

    open approach.

    0SPB48Z.................. Removal of spacer from and 0SRE0JA.................. Replacement of left hip

    left hip joint, joint, acetabular

    percutaneous endoscopic surface with synthetic

    approach. substitute, uncemented,

    open approach.

    0SPB48Z.................. Removal of spacer from and 0SRE0JZ.................. Replacement of left hip

    left hip joint, joint, acetabular

    percutaneous endoscopic surface with synthetic

    approach. substitute, open

    approach.

    0SPB48Z.................. Removal of spacer from and 0SRS019.................. Replacement of left hip

    left hip joint, joint, femoral surface

    percutaneous endoscopic with metal synthetic

    approach. substitute, cemented,

    open approach.

    0SPB48Z.................. Removal of spacer from and 0SRS01A.................. Replacement of left hip

    left hip joint, joint, femoral surface

    percutaneous endoscopic with metal synthetic

    approach. substitute, uncemented,

    open approach.

    0SPB48Z.................. Removal of spacer from and 0SRS01Z.................. Replacement of left hip

    left hip joint, joint, femoral surface

    percutaneous endoscopic with metal synthetic

    approach. substitute, open

    approach.

    0SPB48Z.................. Removal of spacer from and 0SRS039.................. Replacement of left hip

    left hip joint, joint, femoral surface

    percutaneous endoscopic with ceramic synthetic

    approach. substitute, cemented,

    open approach.

    0SPB48Z.................. Removal of spacer from and 0SRS03A.................. Replacement of left hip

    left hip joint, joint, femoral surface

    percutaneous endoscopic with ceramic synthetic

    approach. substitute, uncemented,

    open approach.

    0SPB48Z.................. Removal of spacer from and 0SRS03Z.................. Replacement of left hip

    left hip joint, joint, femoral surface

    percutaneous endoscopic with ceramic synthetic

    approach. substitute, open

    approach.

    0SPB48Z.................. Removal of spacer from and 0SRS0J9.................. Replacement of left hip

    left hip joint, joint, femoral surface

    percutaneous endoscopic with synthetic

    approach. substitute, cemented,

    open approach.

    0SPB48Z.................. Removal of spacer from and 0SRS0JA.................. Replacement of left hip

    left hip joint, joint, femoral surface

    percutaneous endoscopic with synthetic

    approach. substitute, uncemented,

    open approach.

    0SPB48Z.................. Removal of spacer from and 0SRS0JZ.................. Replacement of left hip

    left hip joint, joint, femoral surface

    percutaneous endoscopic with synthetic

    approach. substitute, open

    approach.

    0SPB48Z.................. Removal of spacer from and 0SUB09Z.................. Supplement left hip

    left hip joint, joint with liner, open

    percutaneous endoscopic approach.

    approach.

    0SPB48Z.................. Removal of spacer from and 0SUE09Z.................. Supplement left hip

    left hip joint, joint, acetabular

    percutaneous endoscopic surface with liner,

    approach. open approach.

    0SPB48Z.................. Removal of spacer from and 0SUS09Z.................. Supplement left hip

    left hip joint, joint, femoral surface

    percutaneous endoscopic with liner, open

    approach. approach.

    0SPB4JZ.................. Removal of synthetic and 0SRB019.................. Replacement of left hip

    substitute from left joint with metal

    hip joint, percutaneous synthetic substitute,

    endoscopic approach. cemented, open

    approach.

    0SPB4JZ.................. Removal of synthetic and 0SRB01A.................. Replacement of left hip

    substitute from left joint with metal

    hip joint, percutaneous synthetic substitute,

    endoscopic approach. uncemented, open

    approach.

    0SPB4JZ.................. Removal of synthetic and 0SRB01Z.................. Replacement of left hip

    substitute from left joint with metal

    hip joint, percutaneous synthetic substitute,

    endoscopic approach. open approach.

    0SPB4JZ.................. Removal of synthetic and 0SRB029.................. Replacement of left hip

    substitute from left joint with metal on

    hip joint, percutaneous polyethylene synthetic

    endoscopic approach. substitute, cemented,

    open approach.

    0SPB4JZ.................. Removal of synthetic and 0SRB02A.................. Replacement of left hip

    substitute from left joint with metal on

    hip joint, percutaneous polyethylene synthetic

    endoscopic approach. substitute, uncemented,

    open approach.

    0SPB4JZ.................. Removal of synthetic and 0SRB02Z.................. Replacement of left hip

    substitute from left joint with metal on

    hip joint, percutaneous polyethylene synthetic

    endoscopic approach. substitute, open

    approach.

    0SPB4JZ.................. Removal of synthetic and 0SRB039.................. Replacement of left hip

    substitute from left joint with ceramic

    hip joint, percutaneous synthetic substitute,

    endoscopic approach. cemented, open

    approach.

    0SPB4JZ.................. Removal of synthetic and 0SRB03A.................. Replacement of left hip

    substitute from left joint with ceramic

    hip joint, percutaneous synthetic substitute,

    endoscopic approach. uncemented, open

    approach.

    Page 49404

    0SPB4JZ.................. Removal of synthetic and 0SRB03Z.................. Replacement of left hip

    substitute from left joint with ceramic

    hip joint, percutaneous synthetic substitute,

    endoscopic approach. open approach.

    0SPB4JZ.................. Removal of synthetic and 0SRB049.................. Replacement of left hip

    substitute from left joint with ceramic on

    hip joint, percutaneous polyethylene synthetic

    endoscopic approach. substitute, cemented,

    open approach.

    0SPB4JZ.................. Removal of synthetic and 0SRB04A.................. Replacement of left hip

    substitute from left joint with ceramic on

    hip joint, percutaneous polyethylene synthetic

    endoscopic approach. substitute, uncemented,

    open approach.

    0SPB4JZ.................. Removal of synthetic and 0SRB04Z.................. Replacement of left hip

    substitute from left joint with ceramic on

    hip joint, percutaneous polyethylene synthetic

    endoscopic approach. substitute, open

    approach.

    0SPB4JZ.................. Removal of synthetic and 0SRB0J9.................. Replacement of left hip

    substitute from left joint with synthetic

    hip joint, percutaneous substitute, cemented,

    endoscopic approach. open approach.

    0SPB4JZ.................. Removal of synthetic and 0SRB0JA.................. Replacement of left hip

    substitute from left joint with synthetic

    hip joint, percutaneous substitute, uncemented,

    endoscopic approach. open approach.

    0SPB4JZ.................. Removal of synthetic and 0SRB0JZ.................. Replacement of left hip

    substitute from left joint with synthetic

    hip joint, percutaneous substitute, open

    endoscopic approach. approach.

    0SPB4JZ.................. Removal of synthetic and 0SRE009.................. Replacement of left hip

    substitute from left joint, acetabular

    hip joint, percutaneous surface with

    endoscopic approach. polyethylene synthetic

    substitute, cemented,

    open approach.

    0SPB4JZ.................. Removal of synthetic and 0SRE00A.................. Replacement of left hip

    substitute from left joint, acetabular

    hip joint, percutaneous surface with

    endoscopic approach. polyethylene synthetic

    substitute, uncemented,

    open approach.

    0SPB4JZ.................. Removal of synthetic and 0SRE00Z.................. Replacement of left hip

    substitute from left joint, acetabular

    hip joint, percutaneous surface with

    endoscopic approach. polyethylene synthetic

    substitute, open

    approach.

    0SPB4JZ.................. Removal of synthetic and 0SRE019.................. Replacement of left hip

    substitute from left joint, acetabular

    hip joint, percutaneous surface with metal

    endoscopic approach. synthetic substitute,

    cemented, open

    approach.

    0SPB4JZ.................. Removal of synthetic and 0SRE01A.................. Replacement of left hip

    substitute from left joint, acetabular

    hip joint, percutaneous surface with metal

    endoscopic approach. synthetic substitute,

    uncemented, open

    approach.

    0SPB4JZ.................. Removal of synthetic and 0SRE01Z.................. Replacement of left hip

    substitute from left joint, acetabular

    hip joint, percutaneous surface with metal

    endoscopic approach. synthetic substitute,

    open approach.

    0SPB4JZ.................. Removal of synthetic and 0SRE039.................. Replacement of left hip

    substitute from left joint, acetabular

    hip joint, percutaneous surface with ceramic

    endoscopic approach. synthetic substitute,

    cemented, open

    approach.

    0SPB4JZ.................. Removal of synthetic and 0SRE03A.................. Replacement of left hip

    substitute from left joint, acetabular

    hip joint, percutaneous surface with ceramic

    endoscopic approach. synthetic substitute,

    uncemented, open

    approach.

    0SPB4JZ.................. Removal of synthetic and 0SRE03Z.................. Replacement of left hip

    substitute from left joint, acetabular

    hip joint, percutaneous surface with ceramic

    endoscopic approach. synthetic substitute,

    open approach.

    0SPB4JZ.................. Removal of synthetic and 0SRE0J9.................. Replacement of left hip

    substitute from left joint, acetabular

    hip joint, percutaneous surface with synthetic

    endoscopic approach. substitute, cemented,

    open approach.

    0SPB4JZ.................. Removal of synthetic and 0SRE0JA.................. Replacement of left hip

    substitute from left joint, acetabular

    hip joint, percutaneous surface with synthetic

    endoscopic approach. substitute, uncemented,

    open approach.

    0SPB4JZ.................. Removal of synthetic and 0SRE0JZ.................. Replacement of left hip

    substitute from left joint, acetabular

    hip joint, percutaneous surface with synthetic

    endoscopic approach. substitute, open

    approach.

    0SPB4JZ.................. Removal of synthetic and 0SRS019.................. Replacement of left hip

    substitute from left joint, femoral surface

    hip joint, percutaneous with metal synthetic

    endoscopic approach. substitute, cemented,

    open approach.

    0SPB4JZ.................. Removal of synthetic and 0SRS01A.................. Replacement of left hip

    substitute from left joint, femoral surface

    hip joint, percutaneous with metal synthetic

    endoscopic approach. substitute, uncemented,

    open approach.

    0SPB4JZ.................. Removal of synthetic and 0SRS01Z.................. Replacement of left hip

    substitute from left joint, femoral surface

    hip joint, percutaneous with metal synthetic

    endoscopic approach. substitute, open

    approach.

    0SPB4JZ.................. Removal of synthetic and 0SRS039.................. Replacement of left hip

    substitute from left joint, femoral surface

    hip joint, percutaneous with ceramic synthetic

    endoscopic approach. substitute, cemented,

    open approach.

    0SPB4JZ.................. Removal of synthetic and 0SRS03A.................. Replacement of left hip

    substitute from left joint, femoral surface

    hip joint, percutaneous with ceramic synthetic

    endoscopic approach. substitute, uncemented,

    open approach.

    0SPB4JZ.................. Removal of synthetic and 0SRS03Z.................. Replacement of left hip

    substitute from left joint, femoral surface

    hip joint, percutaneous with ceramic synthetic

    endoscopic approach. substitute, open

    approach.

    0SPB4JZ.................. Removal of synthetic and 0SRS0J9.................. Replacement of left hip

    substitute from left joint, femoral surface

    hip joint, percutaneous with synthetic

    endoscopic approach. substitute, cemented,

    open approach.

    Page 49405

    0SPB4JZ.................. Removal of synthetic and 0SRS0JA.................. Replacement of left hip

    substitute from left joint, femoral surface

    hip joint, percutaneous with synthetic

    endoscopic approach. substitute, uncemented,

    open approach.

    0SPB4JZ.................. Removal of synthetic and 0SRS0JZ.................. Replacement of left hip

    substitute from left joint, femoral surface

    hip joint, percutaneous with synthetic

    endoscopic approach. substitute, open

    approach.

    0SPB4JZ.................. Removal of synthetic and 0SUB09Z.................. Supplement left hip

    substitute from left joint with liner, open

    hip joint, percutaneous approach.

    endoscopic approach.

    0SPB4JZ.................. Removal of synthetic and 0SUE09Z.................. Supplement left hip

    substitute from left joint, acetabular

    hip joint, percutaneous surface with liner,

    endoscopic approach. open approach.

    0SPB4JZ.................. Removal of synthetic and 0SUS09Z.................. Supplement left hip

    substitute from left joint, femoral surface

    hip joint, percutaneous with liner, open

    endoscopic approach. approach.

    0SPC09Z.................. Removal of liner from and 0SRC0J9.................. Replacement of right

    right knee joint, open knee joint with

    approach. synthetic substitute,

    cemented, open

    approach.

    0SPC09Z.................. Removal of liner from and 0SRC0JA.................. Replacement of right

    right knee joint, open knee joint with

    approach. synthetic substitute,

    uncemented, open

    approach.

    0SPC09Z.................. Removal of liner from and 0SRC0JZ.................. Replacement of right

    right knee joint, open knee joint with

    approach. synthetic substitute,

    open approach.

    0SPC09Z.................. Removal of liner from and 0SRT0J9.................. Replacement of right

    right knee joint, open knee joint, femoral

    approach. surface with synthetic

    substitute, cemented,

    open approach.

    0SPC09Z.................. Removal of liner from and 0SRT0JA.................. Replacement of right

    right knee joint, open knee joint, femoral

    approach. surface with synthetic

    substitute, uncemented,

    open approach.

    0SPC09Z.................. Removal of liner from and 0SRT0JZ.................. Replacement of right

    right knee joint, open knee joint, femoral

    approach. surface with synthetic

    substitute, open

    approach.

    0SPC09Z.................. Removal of liner from and 0SRV0J9.................. Replacement of right

    right knee joint, open knee joint, tibial

    approach. surface with synthetic

    substitute, cemented,

    open approach.

    0SPC09Z.................. Removal of liner from and 0SRV0JA.................. Replacement of right

    right knee joint, open knee joint, tibial

    approach. surface with synthetic

    substitute, uncemented,

    open approach.

    0SPC09Z.................. Removal of liner from and 0SRV0JZ.................. Replacement of right

    right knee joint, open knee joint, tibial

    approach. surface with synthetic

    substitute, open

    approach.

    0SPC0JZ.................. Removal of synthetic and 0SRT0J9.................. Replacement of right

    substitute from right knee joint, femoral

    knee joint, open surface with synthetic

    approach. substitute, cemented,

    open approach.

    0SPC0JZ.................. Removal of synthetic and 0SRT0JA.................. Replacement of right

    substitute from right knee joint, femoral

    knee joint, open surface with synthetic

    approach. substitute, uncemented,

    open approach.

    0SPC0JZ.................. Removal of synthetic and 0SRV0J9.................. Replacement of right

    substitute from right knee joint, tibial

    knee joint, open surface with synthetic

    approach. substitute, cemented,

    open approach.

    0SPC0JZ.................. Removal of synthetic and 0SRV0JA.................. Replacement of right

    substitute from right knee joint, tibial

    knee joint, open surface with synthetic

    approach. substitute, uncemented,

    open approach.

    0SPC4JZ.................. Removal of synthetic and 0SRT0J9.................. Replacement of right

    substitute from right knee joint, femoral

    knee joint, surface with synthetic

    percutaneous endoscopic substitute, cemented,

    approach. open approach.

    0SPC4JZ.................. Removal of synthetic and 0SRT0JA.................. Replacement of right

    substitute from right knee joint, femoral

    knee joint, surface with synthetic

    percutaneous endoscopic substitute, uncemented,

    approach. open approach.

    0SPC4JZ.................. Removal of synthetic and 0SRV0J9.................. Replacement of right

    substitute from right knee joint, tibial

    knee joint, surface with synthetic

    percutaneous endoscopic substitute, cemented,

    approach. open approach.

    0SPC4JZ.................. Removal of synthetic and 0SRV0JA.................. Replacement of right

    substitute from right knee joint, tibial

    knee joint, surface with synthetic

    percutaneous endoscopic substitute, uncemented,

    approach. open approach.

    0SPD09Z.................. Removal of liner from and 0SRD0J9.................. Replacement of left knee

    left knee joint, open joint with synthetic

    approach. substitute, cemented,

    open approach.

    0SPD09Z.................. Removal of liner from and 0SRD0JA.................. Replacement of left knee

    left knee joint, open joint with synthetic

    approach. substitute, uncemented,

    open approach.

    0SPD09Z.................. Removal of liner from and 0SRD0JZ.................. Replacement of left knee

    left knee joint, open joint with synthetic

    approach. substitute, open

    approach.

    0SPD09Z.................. Removal of liner from and 0SRU0J9.................. Replacement of left knee

    left knee joint, open joint, femoral surface

    approach. with synthetic

    substitute, cemented,

    open approach.

    0SPD09Z.................. Removal of liner from and 0SRU0JA.................. Replacement of left knee

    left knee joint, open joint, femoral surface

    approach. with synthetic

    substitute, uncemented,

    open approach.

    0SPD09Z.................. Removal of liner from and 0SRU0JZ.................. Replacement of left knee

    left knee joint, open joint, femoral surface

    approach. with synthetic

    substitute, open

    approach.

    0SPD09Z.................. Removal of liner from and 0SRW0J9.................. Replacement of left knee

    left knee joint, open joint, tibial surface

    approach. with synthetic

    substitute, cemented,

    open approach.

    Page 49406

    0SPD09Z.................. Removal of liner from and 0SRW0JA.................. Replacement of left knee

    left knee joint, open joint, tibial surface

    approach. with synthetic

    substitute, uncemented,

    open approach.

    0SPD09Z.................. Removal of liner from and 0SRW0JZ.................. Replacement of left knee

    left knee joint, open joint, tibial surface

    approach. with synthetic

    substitute, open

    approach.

    0SPD0JZ.................. Removal of synthetic and 0SRU0J9.................. Replacement of left knee

    substitute from left joint, femoral surface

    knee joint, open with synthetic

    approach. substitute, cemented,

    open approach.

    0SPD0JZ.................. Removal of synthetic and 0SRU0JA.................. Replacement of left knee

    substitute from left joint, femoral surface

    knee joint, open with synthetic

    approach. substitute, uncemented,

    open approach.

    0SPD0JZ.................. Removal of synthetic and 0SRW0J9.................. Replacement of left knee

    substitute from left joint, tibial surface

    knee joint, open with synthetic

    approach. substitute, cemented,

    open approach.

    0SPD0JZ.................. Removal of synthetic and 0SRW0JA.................. Replacement of left knee

    substitute from left joint, tibial surface

    knee joint, open with synthetic

    approach. substitute, uncemented,

    open approach.

    0SPD0JZ.................. Removal of synthetic and 0SRW0JZ.................. Replacement of left knee

    substitute from left joint, tibial surface

    knee joint, open with synthetic

    approach. substitute, open

    approach.

    0SPD4JZ.................. Removal of synthetic and 0SRU0J9.................. Replacement of left knee

    substitute from left joint, femoral surface

    knee joint, with synthetic

    percutaneous endoscopic substitute, cemented,

    approach. open approach.

    0SPD4JZ.................. Removal of synthetic and 0SRU0JA.................. Replacement of left knee

    substitute from left joint, femoral surface

    knee joint, with synthetic

    percutaneous endoscopic substitute, uncemented,

    approach. open approach.

    0SPD4JZ.................. Removal of synthetic and 0SRW0J9.................. Replacement of left knee

    substitute from left joint, tibial surface

    knee joint, with synthetic

    percutaneous endoscopic substitute, cemented,

    approach. open approach.

    0SPD4JZ.................. Removal of synthetic and 0SRW0JA.................. Replacement of left knee

    substitute from left joint, tibial surface

    knee joint, with synthetic

    percutaneous endoscopic substitute, uncemented,

    approach. open approach.

    0SPD4JZ.................. Removal of synthetic and 0SRW0JZ.................. Replacement of left knee

    substitute from left joint, tibial surface

    knee joint, with synthetic

    percutaneous endoscopic substitute, open

    approach. approach.

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

  195. Spinal Fusion

    We received a request to revise the titles of MS-DRGs 456, 457, and 458 (Spinal Fusion Except Cervical with Spinal Curvature/Malignancy/

    Infection or 9+ Fusion with MCC, with CC, and without CC/MCC, respectively) for the ICD-10 MS-DRGs so that they more closely correspond to the terminology used to describe the ICD-10-PCS procedure codes without changing the ICD-10 MS-DRG logic. We agree with the requestor that revising the titles of these MS-DRGs would more appropriately identify the procedures classified under these groupings. Therefore, in the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24395), we proposed new titles for these three MS-DRGs that would change the reference of ``9+ Fusions'' to ``Extensive Fusions.''

    We invited public comments on our proposal.

    Comment: Several commenters supported the proposal to modify the titles for ICD-10 MS-DRGs 456 through 458. The commenters stated that the proposal was reasonable, given the data and information provided.

    Response: We appreciate the commenters' support.

    After consideration of the public comments we received, we are finalizing our proposal to modify the titles for ICD-10 MS-DRGs 456 through 458. The final title revisions to MS-DRGs 456, 457, and 458 for the FY 2016 ICD-10 MS-DRGs Version 33 are as follows:

    MS-DRG 456 (Spinal Fusion Except Cervical with Spinal Curvature/Malignancy/Infection or Extensive Fusion with MCC);

    MS-DRG 457 (Spinal Fusion Except Cervical with Spinal Curvature/Malignancy/Infection or Extensive Fusion with CC); and

    MS-DRG 458 (Spinal Fusion Except Cervical with Spinal Curvature/Malignancy/Infection or Extensive Fusion without CC/MCC).

    5. MDC 14 (Pregnancy, Childbirth and the Puerperium): MS-DRG 775 (Vaginal Delivery Without Complicating Diagnosis)

    We received a request to modify the logic for ICD-10 MS-DRG 775 (Vaginal Delivery without Complicating Diagnosis) so that the procedure code for the induction of labor with a cervical ripening gel would not group to the incorrect MS-DRG when a normal delivery has occurred. ICD-

    10-PCS procedure code 3E0P7GC (Introduction of other therapeutic substance into female reproductive, via natural or artificial opening) describes this procedure.

    We reviewed how this procedure code is currently classified under the ICD-10 MS-DRGs Version 32 and noted that it is currently designated as an operating room (O.R.) procedure code that affects MS-DRG assignment. In the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24395), we agreed with the requestor that the current logic for ICD-10-PCS procedure code 3E0P7GC did not result in the appropriate MS-DRG assignment. The result of our analysis suggested that this code should not be designated as an O.R. code. Our clinical advisors agreed that this procedure did not require the intensity or complexity of service and resource utilization to merit an O.R. designation under ICD-10. Therefore, in the proposed rule, we proposed to make ICD-10-PCS procedure code 3E0P7GC a non-O.R. code so that cases reporting this procedure code will group to the appropriate MS-DRG assignment. We invited public comments on our proposal.

    Comment: Several commenters supported the proposal to modify the logic for ICD-10 MS-DRG 775 so that procedure code 3E0P7GC would not group to the incorrect MS-DRG when a normal delivery has occurred. The commenters stated that the proposal

    Page 49407

    was reasonable, given the data and information provided.

    Response: We appreciate the commenters' support for our proposal.

    After consideration of the public comments received, we are finalizing our proposal to modify the logic for ICD-10 MS-DRG 775 so that ICD-10-PCS procedure code 3E0P7GC will not group to the incorrect MS-DRG when a normal delivery has occurred.

    Our analysis of ICD-10-PCS procedure code 3E0P7GC also prompted the review of additional, similar codes that describe the introduction of a substance. We evaluated the following ICD-10-PCS procedure codes:

    3E0P76Z (Introduction of nutritional substance into female reproductive, via natural or artificial opening);

    3E0P77Z (Introduction of electrolytic and water balance substance into female reproductive, via natural or artificial opening);

    3E0P7SF (Introduction of other gas into female reproductive, via natural or artificial opening);

    3E0P83Z (Introduction of anti-inflammatory into female reproductive, via natural or artificial opening endoscopic);

    3E0P86Z (Introduction of nutritional substance into female reproductive, via natural or artificial opening endoscopic);

    3E0P87Z (Introduction of electrolytic and water balance substance into female reproductive, via natural or artificial opening endoscopic);

    3E0P8GC (Introduction of other therapeutic substance into female reproductive, via natural or artificial opening endoscopic); and

    3E0P8SF (Introduction of other gas into female reproductive, via natural or artificial opening endoscopic).

    From our analysis, we determined that these codes also are currently designated as O.R. codes which affect MS-DRG assignment. Our clinical advisors recommended that these codes should also be designated as non-O.R. because they do not require the intensity or complexity of service and resource utilization to merit an O.R. designation under the ICD-10 MS-DRGs. As a result of our analysis and based on our clinical advisors' recommendation, in the FY 2016 IPPS/

    LTCH PPS proposed rule (80 FR 24395), we proposed to designate the above listed ICD-10-PCS procedure codes as non-O.R. procedure codes to ensure that these codes will group to the appropriate MS-DRG assignment.

    We invited public comments on our proposal.

    Comment: Several commenters agreed with the proposal to change the designation for the additional ICD-10-PCS codes listed in the proposed rule describing the introduction of a substance from O.R. to non-O.R. The commenters stated that the proposal was reasonable, given the data and information provided.

    Response: We appreciate the commenters' support.

    After consideration of the public comments received, we are finalizing our proposal to designate the following ICD-10-PCS procedure codes as non-O.R. for the FY 2016 ICD-10 MS-DRGs Version 33: 3E0P76Z; 3E0P77Z; 3E0P7SF; 3E0P83Z; 3E0P86Z; 3E0P87Z; 3E0P8GC; and 3E0P8SF.

    6. MDC 21 (Injuries, Poisonings and Toxic Effects of Drugs): CroFab Antivenin Drug

    We received a request that CMS change the MS-DRG assignment for antivenom cases from MS-DRG 917 and 918 (Poisoning & Toxic Effects of Drugs with and without MCC, respectively). For the FY 2016 IPPS/LTCH PPS proposed rule, for these MS-DRGs, we examined claims data from the December 2014 update of the FY 2014 MedPAR file for cases reporting ICD-9-CM diagnosis codes of a principal diagnosis 989.5 (Toxic effect of venom), a secondary diagnosis ICD-9-CM E code of E905.0 (Venomous snakes and lizards), and the ICD-9-CM procedure code of 99.16 (Injection of antidote), which is a non-O.R. code and does not impact the MS-DRG assignment.

    For the ICD-9-CM diagnosis code 989.5 (Toxic effect of venom), the ICD-10-CM provides more detailed diagnosis codes for these toxic effects of venom cases as shown in the following table:

    ICD-10-CM Code Translations for ICD-9-CM Diagnosis Code 989.5

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

    ICD-10-CM Code Code description

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

    T63.001A................. Toxic effect of unspecified snake venom,

    accidental (unintentional), initial

    encounter.

    T63.011A................. Toxic effect of rattlesnake venom, accidental

    (unintentional) initial encounter.

    T63.021A................. Toxic effect of coral snake venom, accidental

    (unintentional), initial encounter.

    T63.031A................. Toxic effect of taipan venom, accidental

    (unintentional), initial encounter.

    T63.041A................. Toxic effect of cobra venom, accidental

    (unintentional), initial encounter.

    T63.061A................. Toxic effect of venom of other North and

    South American snake, accidental

    (unintentional), initial encounter.

    T63.71A.................. Toxic effect of venom of other Australian

    snake, accidental (unintentional), initial

    encounter.

    T63.081A................. Toxic effect of venom of other African and

    Asian snake, accidental (unintentional),

    initial encounter.

    T63.091A................. Toxic effect of venom of other snake,

    accidental (unintentional), initial

    encounter.

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

    For the ICD-9-CM Supplementary Classification of External Causes of Injury and Poisoning code E905.0 (Venomous snakes and lizards), ICD-10-

    CM provides more detailed diagnosis codes for these cases as shown in the following table:

    ICD-10-CM Code Translations for ICD-9-CM Code E905.0

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

    ICD-10-CM Code Code description

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

    T63.001A................. Toxic effect of unspecified snake venom,

    accidental (unintentional), initial

    encounter.

    T63.011A................. Toxic effect of rattlesnake venom, accidental

    (unintentional) initial encounter.

    T63.021A................. Toxic effect of coral snake venom, accidental

    (unintentional), initial encounter.

    T63.031A................. Toxic effect of taipan venom, accidental

    (unintentional), initial encounter.

    T63.041A................. Toxic effect of cobra venom, accidental

    (unintentional), initial encounter.

    T63.061A................. Toxic effect of venom of other North and

    South American snake, accidental

    (unintentional), initial encounter.

    Page 49408

    T63.71A.................. Toxic effect of venom of other Australian

    snake, accidental (unintentional), initial

    encounter.

    T63.081A................. Toxic effect of venom of other African and

    Asian snake, accidental (unintentional),

    initial encounter.

    T63.091A................. Toxic effect of venom of other snake,

    accidental (unintentional), initial

    encounter.

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

    We examined claims data for reported cases involving injections for snake bites in MS-DRGs 917 and 918 from the December 2014 update of the FY 2014 MedPAR file. Our findings are displayed in the table below.

    Snake Bite With Injections

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

    Number of Average length

    MS-DRG cases of stay Average costs

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

    MS-DRG 917--All cases........................................... 26,393 4.77 $9,983

    MS-DRG 917--Cases with principal diagnosis code 989.5 and 0 0 0

    secondary diagnosis code E905.0 with procedure code 99.16 (non-

    OR)............................................................

    MS-DRG 918--All cases........................................... 24,557 2.90 4,953

    MS-DRG 918--Cases with principal diagnosis code 989.5 and 19 2.16 12,014

    secondary diagnosis code E905.0 with procedure code 99.16 (non-

    OR)............................................................

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

    As shown in the table above, we identified 19 cases involving injections for snake bites reported in MS-DRG 918 only. In the FY 2016 IPPS/LTCH PPS proposed rule, we pointed out that this small number of cases (19) does not provide justification to create a new MS-DRG. The cases are assigned to the same MS-DRG as are other types of poisonings and toxic effects. We were unable to identify another MS-DRG that would be a more appropriate MS-DRG assignment for these cases based on the clinical nature of this condition. The MS-DRGs are a classification system intended to group together diagnoses and procedures with similar clinical characteristics and utilization of resources. Basing a new MS-

    DRG on such a small number of cases (19) could lead to distortions in the relative payment weights for the MS-DRG because several expensive cases could impact the overall relative payment weight. Having larger clinical cohesive groups within an MS-DRG provides greater stability for annual updates to the relative payment weights.

    Our clinical advisors reviewed the data, evaluated these conditions, and recommended that we not change the MS-DRG assignment for procedures involving the injection of the CroFab antivenom drug for snake bites because these cases are clinically similar to other poisoning cases currently assigned to MS-DRGs 917 and 918. Based on the findings in our data analysis and the recommendations of our clinical advisors, in the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24397), we did not propose to create a new MS-DRG for cases of CroFab antivenom drugs for snake bites. We proposed to maintain the current assignment of diagnosis codes in MS-DRGs 917 and 918. We invited public comments on our proposal.

    Comment: A number of commenters supported the proposal to maintain the current MS-DRG assignment for procedures involving CroFab antivenom. The commenters stated that the proposal was reasonable, given the data and information provided.

    Response: We appreciate the commenters' support for our proposal.

    After consideration of the public comments we received, we are finalizing our proposal to maintain the current MS-DRG assignment for procedures involving the CroFab antivenom drug for snakebites to MS-

    DRGs 917 and 918.

    7. MDC 22 (Burns): Additional Severity of Illness Level for MS-DRG 927 (Extensive Burns or Full Thickness Burns With Mechanical Ventilation 96+ Hours With Skin Graft)

    We received a request to add an additional severity level to MS-DRG 927 (Extensive Burns or Full Thickness Burns with Mechanical Ventilation 96+ Hours with Skin Graft). The requestor was concerned about payment for severe burn cases that used dermal regenerative grafts. These grafts are captured by ICD-9-CM procedure code 86.67 (Dermal regenerative graft). The requestor stated that the total cost of these graft cases is significantly greater than the average total costs for all cases in MS-DRG 927. The requestor stated that the dermal regenerative grafts are used to cover large burns where donor skin is not available. The requestor stated that the grafts provide permanent covering of the wound and thus immediate closure of the wound. The requestor asserted that the grafts offer benefits such as the avoidance of infections. The requestor pointed out that MS-DRG 927 is not subdivided into severity of illness levels and recommended an additional severity level be added to address any payment issues for dermal regenerative grafts within MS-DRG 927.

    ICD-10-PCS provides more detailed and specific codes for skin grafts. The ICD-10-PCS codes for skin grafts provide specific information on the part of the body receiving the skin graft, the type of graft, and the approach used to apply the graft. These codes can be found in the table labeled ``OHR (Replacement of Skin)'' in the ICD-10 MS-DRG Version 32 Definitions Manual available on the Internet at: http://www.cms.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-Project.html. As stated earlier, for the ICD-9-CM codes that result in greater than 50 ICD-10-PCS comparable code translations, we referred readers to Table 6P (ICD-10-PCS Code Translations for Final MS-DRG Changes), which is available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html. The table includes the MDC topic, the ICD-9-CM code, and the ICD-10-PCS code translations. In Table 6P.2a, we show the comparable ICD-10-PCS codes for ICD-9-CM code 86.67 (Dermal regenerative graft).

    We examined claims data for cases reported in MS-DRG 927 from the December 2014 update of the FY 2014

    Page 49409

    MedPAR file. The following table shows our findings.

    Extensive Burns or Full Thickness Burns With Mechanical Ventilation 96+ Hours With Skin Graft)

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

    Number of Average length

    MS-DRG cases of stay Average costs

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

    MS-DRG 927--All cases........................................... 171 29.92 $113,844

    MS-DRG 927--Cases with procedure code 86.67..................... 22 33.5 146,903

    MS-DRG 927--Cases with procedure code 86.67 and 96.72 14 38.6 174,372

    (Mechanical ventilation for 96+ hours).........................

    MS-DRG 927--Cases with procedure code 86.67 and without 96.72 8 24.6 98,482

    (Mechanical ventilation for 96+ hours).........................

    MS-DRG 927--All cases with MCC.................................. 131 31.51 121,519

    MS-DRG 927--All cases with CC................................... 38 25.21 91,910

    MS-DRG 927--All cases without CC/MCC............................ 2 15.00 27,872

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

    As shown in the table above, we found a total of 171 cases in MS-

    DRG 927. Of these 171 cases, there were 131 cases with an MCC, 38 cases with a CC, and 2 cases without a CC or an MCC. We determined that the requested new severity level did not meet all of the criteria established in the FY 2008 IPPS final rule (72 FR 47169), and described in section II.G.1.b. of the preamble of the proposed rule, that must be met to warrant the creation of a CC or an MCC subgroup within a base MS-DRG. Specifically, the requested new severity level did not meet the criterion that there are at least 500 cases in the CC or MCC subgroup.

    We also pointed out that the long-term mechanical ventilation cases are driving the costs to a greater extent than the graft cases. We found that the 22 cases that received a graft had average costs of $146,903. The 14 cases that had both 96+ hours of mechanical ventilation and a graft had average costs of $174,372. The 8 cases that had a graft but did not receive 96+ hours of mechanical ventilation had average costs of $98,482.

    Our clinical advisors reviewed this issue and recommended making no MS-DRG updates for MS-DRG 927. They advised us that the dermal regenerative graft cases are appropriately assigned to the MS-DRG 927 because they are clinically similar to other cases within MS-DRG 927. Our clinical advisors also agreed that the cases in MS-DRG 927 do not meet the established criterion for creating a new severity level.

    Based on the findings of our data analysis, the fact that MS-DRG 927 did not meet the criterion for the creation of an additional severity level, and the recommendations of our clinical advisors, in the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24397), we did not propose to create a new severity level for MS-DRG 927. We proposed to maintain the current MS-DRG 927 structure without additional severity levels. We invited public comments on our proposal.

    Comment: A number of commenters supported the proposal to maintain the current MS-DRG 927 structure without creating additional severity levels. The commenters stated that the proposal was reasonable, given the data and information provided.

    Response: We appreciate the commenters' support.

    After consideration of the public comments we received, we are finalizing our proposal to maintain the current MS-DRG 927 structure without creating additional severity levels.

    8. Medicare Code Editor (MCE) Changes

    The Medicare Code Editor (MCE) is a software program that detects and reports errors in the coding of Medicare claims data. Patient diagnoses, procedure(s), and demographic information are entered into the Medicare claims processing systems and are subjected to a series of automated screens. The MCE screens are designed to identify cases that require further review before classification into an MS-DRG.

    As discussed in section II.G.1.a. of the preamble of the FY 2016 IPPS/LTCH PPS proposed rule and this final rule, CMS prepared the ICD-

    10 MS-DRGs Version 32 based on the FY 2015 MS-DRGs (Version 32) that we finalized in the FY 2015 IPPS/LTCH PPS final rule. In November 2014, we made available a Definitions Manual of the ICD-10 MS-DRGs Version 32 and the MCE Version 32 on the ICD-10 MS-DRG Conversion Project Web site at: http://www.cms.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-Project.html. We also prepared a document that described the changes made between Version 31-R to Version 32 to help facilitate a review of the ICD-10 MS-DRGs logic. We produced mainframe and computer software for ICD-10 MS-DRGs Version 32 and MCE Version 32, which was made available to the public in January 2015. Information on ordering the mainframe and computer software through NTIS was made available on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-Project.html under the ``Related Links'' section. We encouraged the public to submit to CMS any comments on areas where they believed the ICD-10 MS-DRG GROUPER and MCE did not accurately reflect the logic and edits found in the ICD-9-CM MS-DRG GROUPER and the MCE.

    For FY 2016, in order to be consistent with the ICD-9-CM MS-DRG GROUPER and MCE Version 32, we proposed to add the ICD-10-CM codes listed in the table below to the ICD-10 MCE Version 33 of the ``Manifestation codes not allowed as principal diagnosis'' edit. Under the MCE, manifestation codes describe the ``manifestation'' of an underlying disease, not the disease itself. Because these codes do not describe the disease itself, they should not be used as principal diagnoses.

    Page 49410

    ICD-10-CM Codes Proposed To Be Added to the Version 33 MCE

    ``Manifestation Codes Not Allowed as Principal Diagnosis'' Edit

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

    ICD-10-CM Code Code description

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

    D75.81................... Myelofibrosis.

    E08.00................... Diabetes mellitus due to underlying condition

    with hyperosmolarity without nonketotic

    hyperglycemic-hyperosmolar coma (NKHHC).

    E08.01................... Diabetes mellitus due to underlying condition

    with hyperosmolarity with coma.

    E08.10................... Diabetes mellitus due to underlying condition

    with ketoacidosis without coma.

    E08.11................... Diabetes mellitus due to underlying condition

    with ketoacidosis with coma.

    E08.21................... Diabetes mellitus due to underlying condition

    with diabetic nephropathy.

    E08.22................... Diabetes mellitus due to underlying condition

    with diabetic chronic kidney disease.

    E08.29................... Diabetes mellitus due to underlying condition

    with other diabetic kidney complication.

    E08.311.................. Diabetes mellitus due to underlying condition

    with unspecified diabetic retinopathy with

    macular edema.

    E08.319.................. Diabetes mellitus due to underlying condition

    with unspecified diabetic retinopathy

    without macular edema.

    E08.321.................. Diabetes mellitus due to underlying condition

    with mild nonproliferative diabetic

    retinopathy with macular edema.

    E08.329.................. Diabetes mellitus due to underlying condition

    with mild nonproliferative diabetic

    retinopathy without macular edema.

    E08.331.................. Diabetes mellitus due to underlying condition

    with moderate nonproliferative diabetic

    retinopathy with macular edema.

    E08.339.................. Diabetes mellitus due to underlying condition

    with moderate nonproliferative diabetic

    retinopathy without macular edema.

    E08.341.................. Diabetes mellitus due to underlying condition

    with severe nonproliferative diabetic

    retinopathy with macular edema.

    E08.349.................. Diabetes mellitus due to underlying condition

    with severe nonproliferative diabetic

    retinopathy without macular edema.

    E08.351.................. Diabetes mellitus due to underlying condition

    with proliferative diabetic retinopathy with

    macular edema.

    E08.359.................. Diabetes mellitus due to underlying condition

    with proliferative diabetic retinopathy

    without macular edema.

    E08.36................... Diabetes mellitus due to underlying condition

    with diabetic cataract.

    E08.39................... Diabetes mellitus due to underlying condition

    with other diabetic ophthalmic complication.

    E08.40................... Diabetes mellitus due to underlying condition

    with diabetic neuropathy, unspecified.

    E08.41................... Diabetes mellitus due to underlying condition

    with diabetic mononeuropathy.

    E08.42................... Diabetes mellitus due to underlying condition

    with diabetic polyneuropathy.

    E08.43................... Diabetes mellitus due to underlying condition

    with diabetic autonomic (poly)neuropathy.

    E08.44................... Diabetes mellitus due to underlying condition

    with diabetic amyotrophy.

    E08.49................... Diabetes mellitus due to underlying condition

    with other diabetic neurological

    complication.

    E08.51................... Diabetes mellitus due to underlying condition

    with diabetic peripheral angiopathy without

    gangrene.

    E08.52................... Diabetes mellitus due to underlying condition

    with diabetic peripheral angiopathy with

    gangrene.

    E08.59................... Diabetes mellitus due to underlying condition

    with other circulatory complications.

    E08.610.................. Diabetes mellitus due to underlying condition

    with diabetic neuropathic arthropathy.

    E08.618.................. Diabetes mellitus due to underlying condition

    with other diabetic arthropathy.

    E08.620.................. Diabetes mellitus due to underlying condition

    with diabetic dermatitis.

    E08.621.................. Diabetes mellitus due to underlying condition

    with foot ulcer.

    E08.622.................. Diabetes mellitus due to underlying condition

    with other skin ulcer.

    E08.628.................. Diabetes mellitus due to underlying condition

    with other skin complications.

    E08.630.................. Diabetes mellitus due to underlying condition

    with periodontal disease.

    E08.638.................. Diabetes mellitus due to underlying condition

    with other oral complications.

    E08.641.................. Diabetes mellitus due to underlying condition

    with hypoglycemia with coma.

    E08.649.................. Diabetes mellitus due to underlying condition

    with hypoglycemia without coma.

    E08.65................... Diabetes mellitus due to underlying condition

    with hyperglycemia.

    E08.69................... Diabetes mellitus due to underlying condition

    with other specified complication.

    E08.8.................... Diabetes mellitus due to underlying condition

    with unspecified complications.

    E08.9.................... Diabetes mellitus due to underlying condition

    without complications.

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

    We invited public comment on our proposal to add the above list of ICD-10-CM diagnosis codes to the ``Manifestation codes not allowed as principal diagnosis'' edit in the FY 2016 ICD-10 MCE Version 33.

    Comment: Several commenters supported the proposal to add the above listed ICD-10-CM diagnosis codes to the ``Manifestation codes not allowed as principal diagnosis'' edit in the FY 2016 ICD-10 MCE Version 33. The commenters stated that the proposed changes for the ICD-10 MCE seemed reasonable, given the data and information provided. However, one commenter asserted that the code description for ICD-10-CM diagnosis code D75.81, ``Myelofibrosis'', as displayed in the table in the proposed rule was inaccurate and that the more accurate long description is ``Secondary myelofibrosis''. The commenter stated that if the proposal for myelofibrosis under the ``Manifestation codes not allowed as principal diagnosis'' edit is restricted to ``secondary myelofibrosis,'' it would support the proposal. This commenter indicated that the disease of myelofibrosis is often the main reason for admission as it is a well-defined myeloproliferative neoplasm.

    The commenter also noted it recently participated in proposals related to expanding coverage indications for hematopoietic stem cell transplant to include patients with a principal diagnosis of myelofibrosis. The commenter stated that primary or idiopathic myelofibrosis is coded with ICD-9-CM code 238.76 (Myelofibrosis with myeloid metaplasia) and will be reported with ICD-10-PCS code D47.1 (Chronic myeloproliferative disease). The commenter expressed a desire for coding of this condition to not create confusion as implementation of ICD-10 approaches and pledged to work with its members to confirm understanding.

    Response: We appreciate the commenters' support of our proposal to add the listed ICD-10-CM diagnosis codes to the ICD-10 MCE Version 33 of the ``Manifestation codes not allowed as principal diagnosis'' edit. With regard to the commenter who asserted that the code description for ICD-10-CM diagnosis code D75.81 was inaccurate and that the more accurate long description is ``Secondary

    Page 49411

    myelofibrosis'', we point out that the official ICD-10-CM diagnosis code title description, as displayed in the 2015 Code Descriptions in Tabular Order file, which is available on the CMS ICD-10 Web site at http://www.cms.gov/Medicare/Coding/ICD10/2015-ICD-10-CM-and-GEMs.html in the Downloads section, is as presented in the FY 2016 IPPS/LTCH PPS proposed rule, ``Myelofibrosis''. In response to the commenter's statement that if the proposal for myelofibrosis under the ``Manifestation codes not allowed as principal diagnosis'' edit is restricted to ``secondary myelofibrosis,'' the commenter would support it, we note that ICD-10-CM diagnosis code D75.81 (Myelofibrosis) has an inclusion term of ``Secondary myelofibrosis NOS''. (Within ICD-10-CM, an inclusion term is defined as a term that is included under certain codes. The term represents a condition for which that code is to be used. The term may also be a synonym of the code title. We refer the reader to the ICD-10-CM Official Guidelines for Coding and Reporting for additional information related to inclusion terms.) As such, we believe the proposal to include ICD-10-CM diagnosis code D75.81 (Myelofibrosis) on the list of ``Manifestation codes not allowed as principal diagnosis'' edit is not inconsistent with the commenter's statement of support for a proposal restricted to ``secondary myelofibrosis.'' In response to the commenter indicating that the disease of myelofibrosis is often the main reason for admission as it is a well-defined myeloproliferative neoplasm, we note that, under both ICD-9-CM and ICD-10-CM, myelofibrosis is a manifestation code. As discussed previously, manifestation codes describe the manifestation of an underlying disease, not the disease itself, and therefore should not be used as a principal diagnosis. We also point out that a ``code first'' note appears at ICD-10-CM diagnosis code D75.81 (Myelofibrosis). The ``code first'' note is an etiology/manifestation coding convention (additional detail can be found in the ICD-10-CM Official Guidelines for Coding and Reporting), indicating that the condition has both an underlying etiology and manifestation due to the underlying etiology.

    The commenter is correct that primary or idiopathic myelofibrosis is coded with ICD-9-CM code 238.76 (Myelofibrosis with myeloid metaplasia) and the comparable ICD-10-PCS procedure code translation is D47.1 (Chronic myeloproliferative disease). We also acknowledge and appreciate that the commenter stated its intent to work with its members to confirm understanding of coding as it relates to myelofibrosis as the transition to ICD-10 approaches. We encourage the commenter to review the ICD-10-CM Official Guidelines for Coding and Reporting to assist in that effort.

    After consideration of the public comments we received, for FY 2016, we are finalizing our proposal to add the ICD-10-PCS codes listed earlier in this section to the ICD-10 MCE Version 33 ``Manifestation codes not allowed as principal diagnosis'' edit, which will ensure consistency with the ICD-9-CM MS-DRG GROUPER and MCE Version 32.

    In the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24398 through 24399), we also proposed to revise the language describing the ``Procedure inconsistent with LOS (Length of stay)'' edit which lists ICD-10-PCS code 5A1955Z (Respiratory ventilation, greater than 96 consecutive hours), effective for the FY 2016 ICD-10 MCE Version 33. Currently, in Version 32 of the ICD-10 MCE, the language describing this ``Procedure inconsistent with LOS (Length of stay)'' edit states: ``The following procedure should only be coded on claims with a length of stay of four days or greater.'' Because the code description of the ICD-10-PCS code is for ventilation that occurs greater than 96 consecutive hours, we proposed to revise the language for the edit to read: ``The following procedure code should only be coded on claims with a length of stay greater than 4 days.'' This proposed revision would clarify the intent of this MCE edit. We invited public comments on our proposal.

    Comment: Several commenters supported the proposal to revise the language describing the ``Procedure inconsistent with LOS (Length of stay)'' edit. The commenters stated that the proposed changes seem reasonable, given the data and information provided.

    Response: We appreciate the commenters' support.

    Consistent with the proposal to revise the language for the ``Procedure inconsistent with LOS (Length of stay)'' edit because the code description for ICD-10-PCS code 5A1955Z is for ventilation that occurs greater than 96 consecutive hours, we determined that it is also necessary to revise the language for the corresponding ICD-10 MS-DRG titles that currently reference the ICD-9-CM terminology for mechanical ventilation of ``96 + hours'' based on the ICD-9-CM procedure code 96.72 (Continuous invasive mechanical ventilation for 96 consecutive hours or more) to instead reflect the terminology for the ICD-10-PCS code translation. Consistent with the logic for the ICD-9-CM MS-DRGs Version 32, ICD-10-PCS code 5A1955Z is assigned to these same MS-DRGs under the ICD-10 MS-DRGs Version 33. Under ICD-9-CM, the following six MS-DRGs contain GROUPER and MCE logic based on procedure code 96.72:

    MS-DRG 003 (ECMO or Tracheostomy with Mechanical Ventilation 96+ Hours or Principal Diagnosis Except, Face Mouth and Neck with Major Operating Room Procedure);

    MS-DRG 004 (Tracheostomy with Mechanical Ventilation 96+ Hours or Principal Diagnosis Except, Face Mouth and Neck without Major Operating Room Procedure);

    MS-DRG 207 (Respiratory System Diagnosis with Ventilator Support 96+Hours);

    MS-DRG 870 (Septicemia or Severe Sepsis with Mechanical Ventilation 96+ Hours);

    MS-DRG 927 (Extensive Burns or Full Thickness Burns with Mechanical Ventilation 96+ Hours with Skin Graft); and

    MS-DRG 933 (Extensive Burns or Full Thickness Burns with Mechanical Ventilation 96+ Hours without Skin Graft).

    The following two MS-DRGs do not include GROUPER and MCE logic based on procedure code 96.72. However, the titles currently include the terminology for without mechanical ventilation of ``96 + hours''.

    MS-DRG 871 (Septicemia or Severe Sepsis without Mechanical Ventilation 96+ Hours with MCC); and

    MS-DRG 872 (Septicemia or Severe Sepsis without Mechanical Ventilation 96+ Hours with CC).

    Therefore, we are revising the titles for the corresponding ICD-10 MS-DRGs as the GROUPER and MCE logic include ICD-10-PCS code 5A1955Z (Respiratory ventilation, greater than 96 consecutive hours) or the language in the title of the MS-DRG includes without mechanical ventilation of ``96 + hours''. The revision to the titles is to add a ``greater than'' sign (>) before the 96 to reflect ``> 96 consecutive hours'' and to remove the ``plus sign'' (+) after the 96.

    After consideration of the public comments received, we are finalizing our proposal to revise the language describing the ``Procedure inconsistent with LOS (Length of stay)'' edit which lists ICD-10-PCS code 5A1955Z (Respiratory ventilation, greater than 96 consecutive hours). Consistent with that proposal, we also are revising the ICD-

    Page 49412

    10 MS-DRG Version 33 titles as follows, effective for FY 2016.

    MS-DRG 003: ``(ECMO or Tracheostomy with Mechanical Ventilation >96 Hours or Principal Diagnosis Except, Face Mouth and Neck with Major Operating Room Procedure'';

    MS-DRG 004: ``Tracheostomy with Mechanical Ventilation >96 Hours or Principal Diagnosis Except, Face Mouth and Neck without Major Operating Room Procedure'';

    MS-DRG 007: ``Respiratory System Diagnosis with Ventilator Support >96 Hours'';

    MS-DRG 870: ``Septicemia or Severe Sepsis with Mechanical Ventilation >96 Hours'';

    MS-DRG 871: ``Septicemia or Severe Sepsis without Mechanical Ventilation >96 Hours with MCC'';

    MS-DRG 872: ``Septicemia or Severe Sepsis without Mechanical Ventilation >96 Hours with CC'';

    MS-DRG 927: ``Extensive Burns or Full Thickness Burns with Mechanical Ventilation >96 Hours with Skin Graft''; and

    MS-DRG 933: ``Extensive Burns or Full Thickness Burns with Mechanical Ventilation >96 Hours without Skin Graft''.

    9. Changes to Surgical Hierarchies

    Some inpatient stays entail multiple surgical procedures, each one of which, occurring by itself, could result in assignment of the case to a different MS-DRG within the MDC to which the principal diagnosis is assigned. Therefore, it is necessary to have a decision rule within the GROUPER by which these cases are assigned to a single MS-DRG. The surgical hierarchy, an ordering of surgical classes from most resource-

    intensive to least resource-intensive, performs that function. Application of this hierarchy ensures that cases involving multiple surgical procedures are assigned to the MS-DRG associated with the most resource-intensive surgical class.

    Because the relative resource intensity of surgical classes can shift as a function of MS-DRG reclassification and recalibrations, for FY 2016, we reviewed the surgical hierarchy of each MDC, as we have for previous reclassifications and recalibrations, to determine if the ordering of classes coincides with the intensity of resource utilization.

    A surgical class can be composed of one or more MS-DRGs. For example, in MDC 11, the surgical class ``kidney transplant'' consists of a single MS-DRG (MS-DRG 652) and the class ``major bladder procedures'' consists of three MS-DRGs (MS-DRGs 653, 654, and 655). Consequently, in many cases, the surgical hierarchy has an impact on more than one MS-DRG. The methodology for determining the most resource-intensive surgical class involves weighting the average resources for each MS-DRG by frequency to determine the weighted average resources for each surgical class. For example, assume surgical class A includes MS-DRGs 001 and 002 and surgical class B includes MS-

    DRGs 003, 004, and 005. Assume also that the average costs of MS-DRG 001 are higher than that of MS-DRG 003, but the average costs of MS-

    DRGs 004 and 005 are higher than the average costs of MS-DRG 002. To determine whether surgical class A should be higher or lower than surgical class B in the surgical hierarchy, we would weigh the average costs of each MS-DRG in the class by frequency (that is, by the number of cases in the MS-DRG) to determine average resource consumption for the surgical class. The surgical classes would then be ordered from the class with the highest average resource utilization to that with the lowest, with the exception of ``other O.R. procedures'' as discussed below.

    This methodology may occasionally result in assignment of a case involving multiple procedures to the lower-weighted MS-DRG (in the highest, most resource-intensive surgical class) of the available alternatives. However, given that the logic underlying the surgical hierarchy provides that the GROUPER search for the procedure in the most resource-intensive surgical class, in cases involving multiple procedures, this result is sometimes unavoidable.

    We note that, notwithstanding the foregoing discussion, there are a few instances when a surgical class with a lower average cost is ordered above a surgical class with a higher average cost. For example, the ``other O.R. procedures'' surgical class is uniformly ordered last in the surgical hierarchy of each MDC in which it occurs, regardless of the fact that the average costs for the MS-DRG or MS-DRGs in that surgical class may be higher than those for other surgical classes in the MDC. The ``other O.R. procedures'' class is a group of procedures that are only infrequently related to the diagnoses in the MDC, but are still occasionally performed on patients with cases assigned to the MDC with these diagnoses. Therefore, assignment to these surgical classes should only occur if no other surgical class more closely related to the diagnoses in the MDC is appropriate.

    A second example occurs when the difference between the average costs for two surgical classes is very small. We have found that small differences generally do not warrant reordering of the hierarchy because, as a result of reassigning cases on the basis of the hierarchy change, the average costs are likely to shift such that the higher-

    ordered surgical class has lower average costs than the class ordered below it.

    Based on the changes that we proposed to make for FY 2016, as discussed in section II.G.3.e. of the preamble of the FY 2016 IPPS/LTCH PPS proposed rule, we proposed to revise the surgical hierarchy for MDC 5 (Diseases and Disorders of the Circulatory System) (80 FR 24399). Specifically, we proposed to delete MS-DRG 237 (Major Cardiovascular Procedures with MCC) and MS-DRG 238 (Major Cardiovascular Procedures without MCC) from the surgical hierarchy. We proposed to sequence proposed new MS-DRG 268 (Aortic and Heart Assist Procedures Except Pulsation Balloon with MCC) and proposed new MS-DRG 269 (Aortic and Heart Assist Procedures Except Pulsation Balloon without MCC) above proposed new MS-DRG 270 (Other Major Cardiovascular Procedures with MCC), proposed new MS-DRG 271 (Other Major Cardiovascular Procedures with CC), and proposed new MS-DRG 272 (Other Major Cardiovascular Procedures without CC/MCC). We proposed to sequence proposed new MS-

    DRGs 270, 271, and 272 above MS-DRG 239 (Amputation for Circulatory System Disorders Except Upper Limb & Toe with MCC). In addition, we proposed to sequence proposed new MS-DRG 273 (Percutaneous Intracardiac Procedures with MCC) and proposed new MS-DRG 274 (Percutaneous Intracardiac Procedures without MCC) above MS-DRG 246 (Percutaneous Cardiovascular Procedure with Drug-eluting Stent with MCC or 4+ Vessels/Stents).

    We invited public comments on our proposals.

    We did not receive any public comments on our proposals for the surgical hierarchy within MDC 5. Therefore, we are finalizing our proposals to delete ICD-9-CM MS-DRG 237 and ICD-9-CM MS-DRG 238 from the surgical hierarchy. We are adopting as final the sequencing of new ICD-10 MS-DRG 268 and new ICD-10 MS-DRG 269 above new ICD-10 MS-DRG 270, new ICD-10MS-DRG 271, and new ICD-10 MS-DRG 272. We also are finalizing our proposal to sequence new ICD-10 MS-DRGs 270, 271, and 272 above ICD-10 MS-DRG 239. Lastly, we are finalizing the sequencing of new ICD-10 MS-DRG 273 and new ICD-10 MS-DRG 274 above ICD-10 MS-DRG 246.

    Page 49413

    10. Changes to the MS-DRG Diagnosis Codes for FY 2016

  196. Major Complications or Comorbidities (MCCs) and Complications or Comorbidities (CC) Severity Levels for FY 2016

    A complete updated MCC, CC, and Non-CC Exclusion List is available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html as follows:

    Table 6I (Complete MCC list);

    Table 6J (Complete CC list); and

    Table 6K (Complete list of CC Exclusions).

  197. Coronary Atherosclerosis Due to Calcified Coronary Lesion

    We received a request that we change the severity levels for ICD-9-

    CM diagnosis codes 414.2 (Chronic total occlusion of coronary artery) and 414.4 (Coronary atherosclerosis due to calcified coronary lesion) from non-CCs to MCCs. The ICD-10-CM codes for these diagnoses are I25.82 (Chronic total occlusion of coronary artery) and I25.84 (Coronary atherosclerosis due to calcified coronary lesion), respectively, and both of these codes are currently classified as non-

    CCs.

    This issue was previously discussed in the FY 2014 IPPS/LTCH PPS proposed rule and final rule (78 FR 27522 and 78 FR 50541 through 50542, respectively), and the FY 2015 IPPS/LTCH PPS proposed rule and final rule (79 FR 28018 and 28019 and 79 FR 49903 and 49904, respectively).

    We examined claims data from the December 2014 update of the FY 2014 MedPAR file for ICD-9-CM diagnosis codes 414.2 and 414.4. The following table shows our findings.

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

    Cnt 1 Cnt 2 Cnt 3

    SDX SDX description CC level Cnt 1 impact Cnt 2 impact Cnt 3 impact

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

    414.2.......................... Chronic total occlusion of Non-CC................... 14,655 1.393 21,222 2.098 20,615 3.046

    coronary artery.

    414.4.......................... Coronary atherosclerosis Non-CC................... 1,752 1.412 3,238 2.148 3,244 3.053

    due to calcified coronary

    lesion.

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

    We ran the data using the criteria described in the FY 2008 IPPS final rule with comment period (72 FR 47169) to determine severity levels for procedures in MS-DRGs. The C1 value reflects a patient with no other secondary diagnosis or with all other secondary diagnoses that are non-CCs. The C2 value reflects a patient with at least one other secondary diagnosis that is a CC, but none that is an MCC. The C3 value reflects a patient with at least one other secondary diagnosis that is an MCC.

    The table above shows that the C1 finding is 1.393 for ICD-9-CM diagnosis code 414.2 and the C1 finding is 1.412 for ICD-9-CM diagnosis code 414.4. A value close to 1.0 in the C1 field suggests that the diagnosis produces the same expected value as a non-CC. A value close to 2.0 suggests the condition is more like a CC than a non-CC, but not as significant in resource usage as an MCC. A value close to 3.0 suggests that the condition is expected to consume resources more similar to an MCC than a CC or a non-CC. The C2 finding was 2.098 for ICD-9-CM diagnosis code 414.2, and the C2 finding was 2.148 for ICD-9-

    CM diagnosis code 414.4. A C2 value close to 2.0 suggests the condition is more like a CC than a non-CC, but not as significant in resource usage as an MCC when there is at least one other secondary diagnosis that is a CC but none that is an MCC. While the C1 value of 1.393 for ICD-9-CM diagnosis code 414.2 and the C1 value of 1.412 for ICD-9-CM diagnosis code 414.4 are above the 1.0 value for a non-CC, these values do not support the reclassification of diagnosis codes 414.2 and 414.4 to MCCs. As stated earlier, a value close to 3.0 suggests the condition is expected to consume resources more similar to an MCC than a CC or a non-CC. The C2 finding of 2.098 for ICD-9-CM diagnosis code 414.2 and the C2 finding of 2.148 for ICD-9-CM diagnosis code 414.4 also do not support reclassifying these diagnosis codes to MCCs.

    Our clinical advisors reviewed the data and evaluated these conditions. They recommended that we not change the severity level of diagnosis codes 414.2 and 414.4 from a non-CC to an MCC. Our clinical advisors did not believe that these diagnoses would increase the severity of illness level of patients. Considering the C1 and C2 ratings of both diagnosis codes 414.2 and 414.4 and the input from our clinical advisors, in the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24399 through 24400), we did not propose to reclassify conditions represented by diagnosis codes 414.2 and 414.4 to MCCs. We proposed to maintain both of these conditions as non-CCs. As stated earlier, the equivalent ICD-10-CM codes for these conditions are codes I25.82 and I25.84, respectively. Therefore, based on the data and clinical analysis, we proposed to maintain ICD-10-CM diagnosis codes I25.82 and I25.84 as non-CCs. We invited public comments on our proposals.

    Comment: A number of commenters supported the proposals to maintain the designation of ICD-10-CM diagnosis codes I25.82 and I25.84 as non-

    CCs. The commenters stated that the proposals were reasonable, given the information that was provided.

    One commenter disagreed with the proposal to maintain code I25.84 as a non-CC. The commenter indicated that it was not able to duplicate the results of C1 and C2 described in the narrative and the table presented in the proposed rule, despite contacting CMS for assistance in running the data. The commenter disagreed with the CMS' clinical advisors that the ICD-9-CM code 414.4 and ICD-10-CM code I25.84 represent conditions that are not at the MCC level. The commenter stated that patients with severe calcified lesions are more difficult to treat and, therefore, require greater resources. The commenter also expressed concerns that hospitals were underreporting cases of patients with calcified lesions.

    Response: We appreciate the commenters' support for our proposals. In response to the commenter who disagreed with our clinical advisors' determination that ICD-9-CM code 414.4 and ICD-10-CM code I25.84 represent conditions that are not at the MCC level, we point out that ICD-9-CM code 414.4 captures patients who are diagnosed as having coronary atherosclerosis due to calcified coronary lesions. This diagnosis code includes patients with any range of calcified lesion, not just those with severe calcified lesions. Therefore, the use of ICD-9-CM code 414.4 is not restricted to those patients who have severe calcified lesions. Hospitals are correctly using this code to report all patients who are determined to have atherosclerosis due to calcified coronary lesions. The same is true for the use of ICD-10-CM code I25.84, which is not restricted to cases with severe calcified

    Page 49414

    lesions. We based our analysis on claims data reported by hospitals. We cannot speculate on the underreporting of this condition on submitted claims. It also appears that the commenter did not follow the correct methodology in attempting to replicate the results for C1 and C2. The categorization of diagnoses as an MCC, CC, or non-CC was accomplished using an iterative approach in which each diagnosis was evaluated to determine the extent to which its presence as a secondary diagnosis resulted in increased hospital resource use. We use the same cost calculations for computing the C1, C2, and C3 values that we use in calculating the relative weights. The cases for each ``C'' statistic are the cases with the secondary diagnosis codes for all the cases in that subset of non-CC cases, CC cases, or MCC cases. For example, the cases that are in the C3 statistic are those cases with one or more MCC secondary diagnosis codes in addition to the secondary diagnosis code under the specific review. Cases that are in the C2 statistic are those cases that do not have any MCC secondary diagnosis codes, but have one or more CC secondary diagnosis codes in addition to the secondary diagnosis code under review. The remaining cases are in the C1 statistic and have only non-CC secondary diagnosis codes along with the secondary diagnosis code under review. Numerical resource impact values were assigned for each diagnosis as follows:

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

    Value Meaning

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

    0................................ Significantly below expected value

    for the non CC subgroup.

    1................................ Approximately equal to expected value

    for the non CC subgroup.

    2................................ Approximately equal to expected value

    for the CC subgroup.

    3................................ Approximately equal to expected value

    for the major CC subgroup.

    4................................ Significantly above the expected

    value for the major CC subgroup.

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

    Each diagnosis for which Medicare data were available was evaluated to determine its impact on resource use and to determine the most appropriate CC subclass (non-CC, CC, or MCC) assignment. In order to make this determination, the average cost for each subset of cases was compared to the expected cost of cases in that subset. An expected average cost is computed across all cases in the data analysis for each base MS-DRG and severity level (1=MCC, 2=CC, and 3=Non-CC). Then, for each case in a subset, the average expected cost is computed based on the base MS-DRG and severity level to which the cases are assigned. The following format was used to evaluate each diagnosis:

    Code Diagnosis Cnt1 C1 Cnt2 C2 Cnt3 C3

    Where count (Cnt) is the number of patients in each subset and C1, C2, and C3 are a measure of the impact on resource use of patients in each of the subsets. A C1 value of 1.412 for a secondary diagnosis code 414.4 (Coronary atherosclerosis due to calcified coronary lesion) means that, for the subset of patients who have the secondary diagnosis and have either no other secondary diagnosis present, or all the other secondary diagnoses present are non-CCs, the impact on resource use of the secondary diagnoses is greater than the expected value for a non-CC by an amount equal to 41.2 percent of the difference between the expected value of a CC and a non-CC (that is, the impact on resource use of the secondary diagnosis is closer to a CC than a non-CC).

    After consideration of the public comments we received, the findings from our claims data, and the input from our clinical advisors noted above, we are finalizing our proposal to maintain ICD-10-CM diagnosis codes I25.82 and I25.84 as non-CCs.

  198. Hydronephrosis

    Some ICD-10-CM diagnosis codes express conditions that are normally coded in ICD-9-CM using two or more ICD-9-CM diagnosis codes. CMS' goal in developing the ICD-10 MS-DRGs was to ensure that a patient case is assigned to the same MS-DRG, regardless of whether the patient record were to be coded in ICD-9-CM or ICD-10-CM/PCS. When one of the ICD-10-

    CM combination codes is used as a principal diagnosis, the cluster of ICD-9-CM codes that would be coded on an ICD-9-CM record was evaluated. If one of the ICD-9-CM codes in the cluster is a CC or an MCC, the single ICD-10-CM combination code used as a principal diagnosis also must imply that the CC or MCC is present. Appendix J of the ICD-10 MS-

    DRG Definitions Manual Version 32 includes two lists. Part 1 is the list of principal diagnosis codes where the ICD-10-CM code is its own MCC. Part 2 is the list of principal diagnosis codes where the ICD-10-

    CM code is its own CC. Appendix J of the ICD-10 MS-DRG Definitions Manual Version 32 is available via the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-Project.html.

    We received a request that the ICD-10-CM combination codes for hydronephrosis due to ureteral stricture and urinary stone (N13.1 and N13.2) be flagged as principal diagnoses that can act as their own CC for MS-DRG grouping purposes.

    In ICD-9-CM, code 591 (Hydronephrosis) is classified as a CC. In ICD-10-CM, hydronephrosis is reported with a combination code if the hydronephrosis is due to a ureteral stricture or urinary stone obstruction of N13.1 (Hydronephrosis with ureteral stricture, not elsewhere classified) and N13.2 (Hydronephrosis with renal and ureteral calculous obstruction). In ICD-10-CM, these two codes (N13.1 and N 13.2) are classified as CCs, but these codes are not recognized as principal diagnoses that act as their own CC (they are not included in the Appendix J of the ICD-10 MS-DRG Definitions Manual Version 32).

    In the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24400), we stated that we agreed with the requestor that ICD-10-CM diagnosis codes N13.1 and N13.2 should be flagged as principal diagnosis codes that can act as their own CC for MS-DRG grouping purposes. Therefore, we proposed that diagnosis codes N13.1 and N13.2 be added to the list of principal diagnoses that act as their own CC in Appendix J of the ICD-10 MS-DRG Definitions Manual Version 33. We invited public comments on our proposal.

    Comment: A number of commenters supported the proposal. The commenters stated that the proposal was reasonable, given the data and information provided.

    Response: We appreciate the commenters' support.

    After consideration of the public comments we received, we are finalizing our proposal to add diagnosis codes N13.1 and N13.2 to the list of principal diagnoses that can act as their own CC in Appendix J of the ICD-10 MS-DRG Definitions Manual Version 33.

    Page 49415

    11. Complications or Comorbidity (CC) Exclusions List for FY 2016

  199. Background of the CC List and the CC Exclusions List

    Under the IPPS MS-DRG classification system, we have developed a standard list of diagnoses that are considered CCs. Historically, we developed this list using physician panels that classified each diagnosis code based on whether the diagnosis, when present as a secondary condition, would be considered a substantial complication or comorbidity. A substantial complication or comorbidity was defined as a condition that, because of its presence with a specific principal diagnosis, would cause an increase in the length of stay by at least 1 day in at least 75 percent of the patients. However, depending on the principal diagnosis of the patient, some diagnoses on the basic list of complications and comorbidities may be excluded if they are closely related to the principal diagnosis. In FY 2008, we evaluated each diagnosis code to determine its impact on resource use and to determine the most appropriate CC subclassification (non-CC, CC, or MCC) assignment. We refer readers to sections II.D.2. and 3. of the preamble of the FY 2008 IPPS final rule with comment period for a discussion of the refinement of CCs in relation to the MS-DRGs we adopted for FY 2008 (72 FR 47152 through 47171).

  200. CC Exclusions List for FY 2016

    In the September 1, 1987 final notice (52 FR 33143) concerning changes to the DRG classification system, we modified the GROUPER logic so that certain diagnoses included on the standard list of CCs would not be considered valid CCs in combination with a particular principal diagnosis. We created the CC Exclusions List for the following reasons: (1) To preclude coding of CCs for closely related conditions; (2) to preclude duplicative or inconsistent coding from being treated as CCs; and (3) to ensure that cases are appropriately classified between the complicated and uncomplicated DRGs in a pair. As we indicated above, we developed a list of diagnoses, using physician panels, to include those diagnoses that, when present as a secondary condition, would be considered a substantial complication or comorbidity. In previous years, we have made changes to the list of CCs, either by adding new CCs or deleting CCs already on the list.

    In the May 19, 1987 proposed notice (52 FR 18877) and the September 1, 1987 final notice (52 FR 33154), we explained that the excluded secondary diagnoses were established using the following five principles:

    Chronic and acute manifestations of the same condition should not be considered CCs for one another;

    Specific and nonspecific (that is, not otherwise specified (NOS)) diagnosis codes for the same condition should not be considered CCs for one another;

    Codes for the same condition that cannot coexist, such as partial/total, unilateral/bilateral, obstructed/unobstructed, and benign/malignant, should not be considered CCs for one another;

    Codes for the same condition in anatomically proximal sites should not be considered CCs for one another; and

    Closely related conditions should not be considered CCs for one another.

    The creation of the CC Exclusions List was a major project involving hundreds of codes. We have continued to review the remaining CCs to identify additional exclusions and to remove diagnoses from the master list that have been shown not to meet the definition of a CC.\6\

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

    \6\ We refer readers to the FY 1989 final rule (53 FR 38485, September 30, 1988) for the revision made for the discharges occurring in FY 1989; the FY 1990 final rule (54 FR 36552, September 1, 1989) for the FY 1990 revision; the FY 1991 final rule (55 FR 36126, September 4, 1990) for the FY 1991 revision; the FY 1992 final rule (56 FR 43209, August 30, 1991) for the FY 1992 revision; the FY 1993 final rule (57 FR 39753, September 1, 1992) for the FY 1993 revision; the FY 1994 final rule (58 FR 46278, September 1, 1993) for the FY 1994 revisions; the FY 1995 final rule (59 FR 45334, September 1, 1994) for the FY 1995 revisions; the FY 1996 final rule (60 FR 45782, September 1, 1995) for the FY 1996 revisions; the FY 1997 final rule (61 FR 46171, August 30, 1996) for the FY 1997 revisions; the FY 1998 final rule (62 FR 45966, August 29, 1997) for the FY 1998 revisions; the FY 1999 final rule (63 FR 40954, July 31, 1998) for the FY 1999 revisions; the FY 2001 final rule (65 FR 47064, August 1, 2000) for the FY 2001 revisions; the FY 2002 final rule (66 FR 39851, August 1, 2001) for the FY 2002 revisions; the FY 2003 final rule (67 FR 49998, August 1, 2002) for the FY 2003 revisions; the FY 2004 final rule (68 FR 45364, August 1, 2003) for the FY 2004 revisions; the FY 2005 final rule (69 FR 49848, August 11, 2004) for the FY 2005 revisions; the FY 2006 final rule (70 FR 47640, August 12, 2005) for the FY 2006 revisions; the FY 2007 final rule (71 FR 47870) for the FY 2007 revisions; the FY 2008 final rule (72 FR 47130) for the FY 2008 revisions; the FY 2009 final rule (73 FR 48510); the FY 2010 final rule (74 FR 43799); the FY 2011 final rule (75 FR 50114); the FY 2012 final rule (76 FR 51542); the FY 2013 final rule (77 FR 53315); the FY 2014 final rule (78 FR 50541), and the FY 2015 final rule (79 FR 49905). In the FY 2000 final rule (64 FR 41490, July 30, 1999), we did not modify the CC Exclusions List because we did not make any changes to the ICD-9-

    CM codes for FY 2000.

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

    The ICD-10 MS-DRGs Version 32 CC Exclusion List is included as Appendix C in the Definitions Manual available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-Project.html.

    In the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24401), we did not propose any changes to the CC Exclusion List for FY 2016. Because we did not propose any changes to the ICD-10 MS-DRGs CC Exclusion List for FY 2016, we did not publish Table 6G (Additions to the CC Exclusion List) or Table 6H (Deletions from the CC Exclusion List). We developed Table 6K (Complete List of CC Exclusions), which is available only via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html. Because of the length of Table 6K, we did not publish it in the Addendum to the proposed rule.

    As we did for the proposed rule, because we are not making any changes to the ICD-10 MS-DRGs CC Exclusion List for FY 2016, we are not publishing Table 6G (Additions to the CC Exclusion List) or Table 6H (Deletions from the CC Exclusion List). We developed Table 6K (Complete List of CC Exclusions), which is available only via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html. Because of the length of Table 6K, we are not publishing it in the Addendum to this final rule. Each of the secondary diagnosis codes for which there is an exclusion is listed in Part 1 of Table 6K. Each of these secondary diagnosis codes is indicated as a CC or an MCC. If the CC or MCC is allowed with all principal diagnoses, the phrase ``NoExcl'' (for no exclusions) follows the CC/MCC indicator. Otherwise, a link is given to a collection of diagnosis codes which, when used as the principal diagnosis, will cause the CC or MCC to be considered as only a non-CC. Part 2 of Table 6K lists codes that are assigned as an MCC only for patients discharged alive. Otherwise, the codes are assigned as a non-CC.

    A complete updated MCC, CC, and Non-CC Exclusions List is available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html.

    Because there are no new, revised, or deleted ICD-10-CM diagnosis codes for FY 2016, we have not developed Table 6A (New Diagnosis Codes), Table 6C (Invalid Diagnosis Codes), or Table 6E (Revised Diagnosis Code Titles), for this final rule and they are not published as part of this final rule. We have developed Table 6B (New Procedure Codes) for new ICD-10-PCS codes which will be implemented on October 1, 2015. Because there are no revised or

    Page 49416

    deleted procedure codes for FY 2016, we have not developed Table 6D (Invalid Procedure Codes) or Table 6F (Revised Procedure Codes).

    In the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24401), we did not propose any additions or deletions to the MS-DRG MCC List for FY 2016 nor any additions or deletions to the MS-DRG CC List for FY 2016. As we did for the proposed rule, for this final rule, we have not developed Tables 6I.1 (Additions to the MCC List), 6I.2 (Deletions to the MCC List), 6J.1 (Additions to the CC List), and 6J.2 (Deletions to the CC List), and they are not published as part of this final rule. We have developed Tables 6L (Principal Diagnosis Is Its Own MCC List) and 6M (Principal Diagnosis Is Its Own CC List). As stated in the Definitions Manual of the ICD-10 MS DRGs Version 32 on the ICD-10 MS-

    DRG Conversion Project Web site at: http://www.cms.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-Project.html, a few ICD-10-CM diagnosis codes express conditions that are normally coded in ICD-9-CM using two or more ICD-9-CM diagnosis codes. In the interest of ensuring that the ICD-10 MS-DRGs place a patient in the same DRG, whenever one of these ICD-10-CM combination codes is used as principal diagnosis, the cluster of ICD-9-CM codes that would be coded on an ICD-9-CM record is considered. If one of the ICD-9-CM codes in the cluster is a CC or an MCC, the single ICD-10-CM combination code used as a principal diagnosis must also imply the CC or MCC that the ICD-9-CM cluster would have presented. The ICD-10-CM diagnoses for which this implication must be made are listed in these tables. We also have developed Table 6M.1 (Additions to Principal Diagnosis Is Its Own CC) to show the two additions to this list for the two principal diagnosis codes acting as their own CC.

    The complete documentation of the ICD-10 MS-DRG Version 32 GROUPER logic, including the current CC Exclusions List, is available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-Project.html. The complete documentation of the ICD-10 MS-DRG GROUPER logic also is available on the CMS Acute Inpatient PPS Web page at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html.

    12. Review of Procedure Codes in MS-DRGs 981 Through 983, 984 Through 986, and 987 Through 989

    Each year, we review cases assigned to former CMS DRG 468 (Extensive O.R. Procedure Unrelated to Principal Diagnosis), CMS DRG 476 (Prostatic O.R. Procedure Unrelated to Principal Diagnosis), and CMS DRG 477 (Nonextensive O.R. Procedure Unrelated to Principal Diagnosis) to determine whether it would be appropriate to change the procedures assigned among these CMS DRGs. Under the MS-DRGs that we adopted for FY 2008, CMS DRG 468 was split three ways and became MS-

    DRGs 981, 982, and 983 (Extensive O.R. Procedure Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively). CMS DRG 476 became MS-DRGs 984, 985, and 986 (Prostatic O.R. Procedure Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively). CMS DRG 477 became MS-DRGs 987, 988, and 989 (Nonextensive O.R. Procedure Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively).

    MS-DRGs 981 through 983, 984 through 986, and 987 through 989 (formerly CMS DRGs 468, 476, and 477, respectively) are reserved for those cases in which none of the O.R. procedures performed are related to the principal diagnosis. These MS-DRGs are intended to capture atypical cases, that is, those cases not occurring with sufficient frequency to represent a distinct, recognizable clinical group. MS-DRGs 984 through 986 (previously CMS DRG 476) are assigned to those discharges in which one or more of the following prostatic procedures are performed and are unrelated to the principal diagnosis:

    60.0 (Incision of prostate);

    60.12 (Open biopsy of prostate);

    60.15 (Biopsy of periprostatic tissue);

    60.18 (Other diagnostic procedures on prostate and periprostatic tissue);

    60.21 (Transurethral prostatectomy);

    60.29 (Other transurethral prostatectomy);

    60.61 (Local excision of lesion of prostate);

    60.69 (Prostatectomy, not elsewhere classified);

    60.81 (Incision of periprostatic tissue);

    60.82 (Excision of periprostatic tissue);

    60.93 (Repair of prostate);

    60.94 (Control of (postoperative) hemorrhage of prostate);

    60.95 (Transurethral balloon dilation of the prostatic urethra);

    60.96 (Transurethral destruction of prostate tissue by microwave thermotherapy);

    60.97 (Other transurethral destruction of prostate tissue by other thermotherapy); and

    60.99 (Other operations on prostate).

    All remaining O.R. procedures are assigned to MS-DRGs 981 through 983 and 987 through 989, with MS-DRGs 987 through 989 assigned to those discharges in which the only procedures performed are nonextensive procedures that are unrelated to the principal diagnosis.\7\

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

    \7\ The original list of the ICD-9-CM procedure codes for the procedures we consider nonextensive procedures, if performed with an unrelated principal diagnosis, was published in Table 6C in section IV. of the Addendum to the FY 1989 final rule (53 FR 38591). As part of the FY 1991 final rule (55 FR 36135), the FY 1992 final rule (56 FR 43212), the FY 1993 final rule (57 FR 23625), the FY 1994 final rule (58 FR 46279), the FY 1995 final rule (59 FR 45336), the FY 1996 final rule (60 FR 45783), the FY 1997 final rule (61 FR 46173), and the FY 1998 final rule (62 FR 45981), we moved several other procedures from DRG 468 to DRG 477, and some procedures from DRG 477 to DRG 468. No procedures were moved in FY 1999, as noted in the final rule (63 FR 40962), in the FY 2000 (64 FR 41496), in the FY 2001 (65 FR 47064), or in the FY 2002 (66 FR 39852). In the FY 2003 final rule (67 FR 49999), we did not move any procedures from DRG 477. However, we did move procedure codes from DRG 468 and placed them in more clinically coherent DRGs. In the FY 2004 final rule (68 FR 45365), we moved several procedures from DRG 468 to DRGs 476 and 477 because the procedures are nonextensive. In the FY 2005 final rule (69 FR 48950), we moved one procedure from DRG 468 to 477. In addition, we added several existing procedures to DRGs 476 and 477. In FY 2006 (70 FR 47317), we moved one procedure from DRG 468 and assigned it to DRG 477. In FY 2007, we moved one procedure from DRG 468 and assigned it to DRGs 479, 553, and 554. In FYs 2008, 2009, 2010, 2011, 2012, 2013, 2014, and 2015, no procedures were moved, as noted in the FY 2008 final rule with comment period (72 FR 46241), in the FY 2009 final rule (73 FR 48513), in the FY 2010 final rule (74 FR 43796), in the FY 2011 final rule (75 FR 50122), in the FY 2012 final rule (76 FR 51549), in the FY 2013 final rule (77 FR 53321), in the FY 2014 final rule (78 FR 50545); and in the FY 2015 final rule (79 FR 49906).

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

    Our review of MedPAR claims data showed that there are no cases that merited movement or should logically be assigned to any of the other MDCs. Therefore, for FY 2016, we did not propose to change the procedures assigned among these MS-DRGs. We invited public comments on our proposal.

    We did not receive any public comments on our proposal and, therefore, are adopting it as final.

  201. Moving Procedure Codes From MS-DRGs 981 Through 983 or MS-DRGs 987 Through 989 into MDCs

    We annually conduct a review of procedures producing assignment to MS-DRGs 981 through 983 (Extensive

    Page 49417

    O.R. procedure unrelated to principal diagnosis with MCC, with CC, and without CC/MCC, respectively) or MS-DRGs 987 through 989 (Nonextensive O.R. procedure unrelated to principal diagnosis with MCC, with CC, and without CC/MCC, respectively) on the basis of volume, by procedure, to see if it would be appropriate to move procedure codes out of these MS-

    DRGs into one of the surgical MS-DRGs for the MDC into which the principal diagnosis falls. The data are arrayed in two ways for comparison purposes. We look at a frequency count of each major operative procedure code. We also compare procedures across MDCs by volume of procedure codes within each MDC.

    We identify those procedures occurring in conjunction with certain principal diagnoses with sufficient frequency to justify adding them to one of the surgical MS-DRGs for the MDC in which the diagnosis falls. As noted above, there are no cases that merited movement or that should logically be assigned to any of the other MDCs. Therefore, for FY 2016, we did not propose to remove any procedures from MS-DRGs 981 through 983 or MS-DRGs 987 through 989 into one of the surgical MS-DRGs for the MDC into which the principal diagnosis is assigned. We invited public comments on our proposal.

    We did not receive any public comments on our proposal and, therefore, are adopting it as final.

  202. Reassignment of Procedures Among MS DRGs 981 Through 983, 984 Through 986, and 987 Through 989

    (1) Annual Review of Procedures

    We also annually review the list of ICD-9-CM procedures that, when in combination with their principal diagnosis code, result in assignment to MS-DRGs 981 through 983, 984 through 986 (Prostatic O.R. procedure unrelated to principal diagnosis with MCC, with CC, or without CC/MCC, respectively), and 987 through 989, to ascertain whether any of those procedures should be reassigned from one of these three MS DRGs to another of the three MS-DRGs based on average costs and the length of stay. We look at the data for trends such as shifts in treatment practice or reporting practice that would make the resulting MS-DRG assignment illogical. If we find these shifts, we would propose to move cases to keep the MS-DRGs clinically similar or to provide payment for the cases in a similar manner. Generally, we move only those procedures for which we have an adequate number of discharges to analyze the data.

    There are no cases representing shifts in treatment practice or reporting practice that would make the resulting MS-DRG assignment illogical, or that merited movement so that cases should logically be assigned to any of the other MDCs. Therefore, for FY 2016, we did not propose to move any procedure codes among these MS-DRGs.

    We did not receive any public comments on our proposal and, therefore, are adopting it as final.

    (2) Review of Cases With Endovascular Embolization Procedures for Epistaxis

    During the comment period for the FY 2015 IPPS/LTCH PPS proposed rule, we received a public comment expressing concern regarding specific procedure codes that are assigned to MS-DRGs 981 through 983; 984 through 986; and 987 through 989 in relation to our discussion of the annual review of these MS-DRGs in section II.G.12. of that proposed rule (79 FR 28020). The commenter noted that the endovascular embolization of the arteries of the branches of the internal maxillary artery is frequently performed for intractable posterior epistaxis (nosebleed). The commenter stated that, currently, diagnosis code 784.7 (Epistaxis) reported with procedure codes 39.75 (Endovascular embolization or occlusion of vessel(s) of head or neck using bare coils) and 39.76 (Endovascular embolization or occlusion of vessel(s) of head or neck using bioactive coils) groups to MS-DRGs 981, 982, and 983. The commenter indicated that it also found this grouping with the ICD-10 MS-DRGs Version 31 using ICD-10-CM diagnosis code R04.0 (Epistaxis) reported with artery occlusion procedure codes. The commenter requested that CMS review these groupings and consider the possibility of reassigning these epistaxis cases with endovascular embolization procedure codes into a more specific MS-DRG.

    We considered this public comment to be outside of the scope of the FY 2015 IPPS/LTCH PPS proposed rule and, therefore, did not address it in the FY 2015 IPPS/LTCH PPS final rule. However, we indicated that we would consider this public comment for possible proposals in future rulemaking as part of our annual review process.

    ICD-10-PCS provides more detailed codes for endovascular embolization or occlusion of vessel(s) of head or neck using bare coils and bioactive coils which are listed in the following table:

    ICD-10-PCS Codes for Endovascular Embolization or Occlusion of Vessel(s)

    of Head or Neck Using Bare Coils and Bioactive Coils

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

    ICD-10-PCS code Code description

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

    03LG0BZ.................. Occlusion of intracranial artery with

    bioactive intraluminal device, open

    approach.

    03LG0DZ.................. Occlusion of intracranial artery with

    intraluminal device, open approach.

    03LG3BZ.................. Occlusion of intracranial artery with

    bioactive intraluminal device, percutaneous

    approach.

    03LG3DZ.................. Occlusion of intracranial artery with

    intraluminal device, percutaneous approach.

    03LG4BZ.................. Occlusion of intracranial artery with

    bioactive intraluminal device, percutaneous

    endoscopic approach.

    03LG4DZ.................. Occlusion of intracranial artery with

    intraluminal device, percutaneous endoscopic

    approach.

    03LH0BZ.................. Occlusion of right common carotid artery with

    bioactive intraluminal device, open

    approach.

    03LH0DZ.................. Occlusion of right common carotid artery with

    intraluminal device, open approach.

    03LH3BZ.................. Occlusion of right common carotid artery with

    bioactive intraluminal device, percutaneous

    approach.

    03LH3DZ.................. Occlusion of right common carotid artery with

    intraluminal device, percutaneous approach.

    03LH4BZ.................. Occlusion of right common carotid artery with

    bioactive intraluminal device, percutaneous

    endoscopic approach.

    03LH4DZ.................. Occlusion of right common carotid artery with

    intraluminal device, percutaneous endoscopic

    approach.

    03LJ0BZ.................. Occlusion of left common carotid artery with

    bioactive intraluminal device, open

    approach.

    03LJ0DZ.................. Occlusion of left common carotid artery with

    intraluminal device, open approach.

    03LJ3BZ.................. Occlusion of left common carotid artery with

    bioactive intraluminal device, percutaneous

    approach.

    03LJ3DZ.................. Occlusion of left common carotid artery with

    intraluminal device, percutaneous approach.

    03LJ4BZ.................. Occlusion of left common carotid artery with

    bioactive intraluminal device, percutaneous

    endoscopic approach.

    03LJ4DZ.................. Occlusion of left common carotid artery with

    intraluminal device, percutaneous endoscopic

    approach.

    Page 49418

    03LK0BZ.................. Occlusion of right internal carotid artery

    with bioactive intraluminal device, open

    approach.

    03LK0DZ.................. Occlusion of right internal carotid artery

    with intraluminal device, open approach.

    03LK3BZ.................. Occlusion of right internal carotid artery

    with bioactive intraluminal device,

    percutaneous approach.

    03LK3DZ.................. Occlusion of right internal carotid artery

    with intraluminal device, percutaneous

    approach.

    03LK4BZ.................. Occlusion of right internal carotid artery

    with bioactive intraluminal device,

    percutaneous endoscopic approach.

    03LK4DZ.................. Occlusion of right internal carotid artery

    with intraluminal device, percutaneous

    endoscopic approach.

    03LL0BZ.................. Occlusion of left internal carotid artery

    with bioactive intraluminal device, open

    approach.

    03LL0DZ.................. Occlusion of left internal carotid artery

    with intraluminal device, open approach.

    03LL3BZ.................. Occlusion of left internal carotid artery

    with bioactive intraluminal device,

    percutaneous approach.

    03LL3DZ.................. Occlusion of left internal carotid artery

    with intraluminal device, percutaneous

    approach.

    03LL4BZ.................. Occlusion of left internal carotid artery

    with bioactive intraluminal device,

    percutaneous endoscopic approach.

    03LL4DZ.................. Occlusion of left internal carotid artery

    with intraluminal device, percutaneous

    endoscopic approach.

    03LM0BZ.................. Occlusion of right external carotid artery

    with bioactive intraluminal device, open

    approach.

    03LM0DZ.................. Occlusion of right external carotid artery

    with intraluminal device, open approach.

    03LM3BZ.................. Occlusion of right external carotid artery

    with bioactive intraluminal device,

    percutaneous approach.

    03LM3DZ.................. Occlusion of right external carotid artery

    with intraluminal device, percutaneous

    approach.

    03LM4BZ.................. Occlusion of right external carotid artery

    with bioactive intraluminal device,

    percutaneous endoscopic approach.

    03LM4DZ.................. Occlusion of right external carotid artery

    with intraluminal device, percutaneous

    endoscopic approach.

    03LN0BZ.................. Occlusion of left external carotid artery

    with bioactive intraluminal device, open

    approach.

    03LN0DZ.................. Occlusion of left external carotid artery

    with intraluminal device, open approach.

    03LN3BZ.................. Occlusion of left external carotid artery

    with bioactive intraluminal device,

    percutaneous approach.

    03LN3DZ.................. Occlusion of left external carotid artery

    with intraluminal device, percutaneous

    approach.

    03LN4BZ.................. Occlusion of left external carotid artery

    with bioactive intraluminal device,

    percutaneous endoscopic approach.

    03LN4DZ.................. Occlusion of left external carotid artery

    with intraluminal device, percutaneous

    endoscopic approach.

    03LP0BZ.................. Occlusion of right vertebral artery with

    bioactive intraluminal device, open

    approach.

    03LP0DZ.................. Occlusion of right vertebral artery with

    intraluminal device, open approach.

    03LP3BZ.................. Occlusion of right vertebral artery with

    bioactive intraluminal device, percutaneous

    approach.

    03LP3DZ.................. Occlusion of right vertebral artery with

    intraluminal device, percutaneous approach.

    03LP4BZ.................. Occlusion of right vertebral artery with

    bioactive intraluminal device, percutaneous

    endoscopic approach.

    03LP4DZ.................. Occlusion of right vertebral artery with

    intraluminal device, percutaneous endoscopic

    approach.

    03LQ0BZ.................. Occlusion of left vertebral artery with

    bioactive intraluminal device, open

    approach.

    03LQ0DZ.................. Occlusion of left vertebral artery with

    intraluminal device, open approach.

    03LQ3BZ.................. Occlusion of left vertebral artery with

    bioactive intraluminal device, percutaneous

    approach.

    03LQ3DZ.................. Occlusion of left vertebral artery with

    intraluminal device, percutaneous approach.

    03LQ4BZ.................. Occlusion of left vertebral artery with

    bioactive intraluminal device, percutaneous

    endoscopic approach.

    03LQ4DZ.................. Occlusion of left vertebral artery with

    intraluminal device, percutaneous endoscopic

    approach.

    03VG0BZ.................. Restriction of intracranial artery with

    bioactive intraluminal device, open

    approach.

    03VG0DZ.................. Restriction of intracranial artery with

    intraluminal device, open approach.

    03VG3BZ.................. Restriction of intracranial artery with

    bioactive intraluminal device, percutaneous

    approach.

    03VG3DZ.................. Restriction of intracranial artery with

    intraluminal device, percutaneous approach.

    03VG4BZ.................. Restriction of intracranial artery with

    bioactive intraluminal device, percutaneous

    endoscopic approach.

    03VG4DZ.................. Restriction of intracranial artery with

    intraluminal device, percutaneous endoscopic

    approach.

    03VH0BZ.................. Restriction of right common carotid artery

    with bioactive intraluminal device, open

    approach.

    03VH0DZ.................. Restriction of right common carotid artery

    with intraluminal device, open approach.

    03VH3BZ.................. Restriction of right common carotid artery

    with bioactive intraluminal device,

    percutaneous approach.

    03VH3DZ.................. Restriction of right common carotid artery

    with intraluminal device, percutaneous

    approach.

    03VH4BZ.................. Restriction of right common carotid artery

    with bioactive intraluminal device,

    percutaneous endoscopic approach.

    03VH4DZ.................. Restriction of right common carotid artery

    with intraluminal device, percutaneous

    endoscopic approach.

    03VJ0BZ.................. Restriction of left common carotid artery

    with bioactive intraluminal device, open

    approach.

    03VJ0DZ.................. Restriction of left common carotid artery

    with intraluminal device, open approach.

    03VJ3BZ.................. Restriction of left common carotid artery

    with bioactive intraluminal device,

    percutaneous approach.

    03VJ3DZ.................. Restriction of left common carotid artery

    with intraluminal device, percutaneous

    approach.

    03VJ4BZ.................. Restriction of left common carotid artery

    with bioactive intraluminal device,

    percutaneous endoscopic approach.

    03VJ4DZ.................. Restriction of left common carotid artery

    with intraluminal device, percutaneous

    endoscopic approach.

    03VK0BZ.................. Restriction of right internal carotid artery

    with bioactive intraluminal device, open

    approach.

    03VK0DZ.................. Restriction of right internal carotid artery

    with intraluminal device, open approach.

    03VK3BZ.................. Restriction of right internal carotid artery

    with bioactive intraluminal device,

    percutaneous approach.

    03VK3DZ.................. Restriction of right internal carotid artery

    with intraluminal device, percutaneous

    approach.

    03VK4BZ.................. Restriction of right internal carotid artery

    with bioactive intraluminal device,

    percutaneous endoscopic approach.

    03VK4DZ.................. Restriction of right internal carotid artery

    with intraluminal device, percutaneous

    endoscopic approach.

    03VL0BZ.................. Restriction of left internal carotid artery

    with bioactive intraluminal device, open

    approach.

    03VL0DZ.................. Restriction of left internal carotid artery

    with intraluminal device, open approach.

    03VL3BZ.................. Restriction of left internal carotid artery

    with bioactive intraluminal device,

    percutaneous approach.

    03VL3DZ.................. Restriction of left internal carotid artery

    with intraluminal device, percutaneous

    approach.

    03VL4BZ.................. Restriction of left internal carotid artery

    with bioactive intraluminal device,

    percutaneous endoscopic approach.

    03VL4DZ.................. Restriction of left internal carotid artery

    with intraluminal device, percutaneous

    endoscopic approach.

    03VM0BZ.................. Restriction of right external carotid artery

    with bioactive intraluminal device, open

    approach.

    03VM0DZ.................. Restriction of right external carotid artery

    with intraluminal device, open approach.

    03VM3BZ.................. Restriction of right external carotid artery

    with bioactive intraluminal device,

    percutaneous approach.

    03VM3DZ.................. Restriction of right external carotid artery

    with intraluminal device, percutaneous

    approach.

    Page 49419

    03VM4BZ.................. Restriction of right external carotid artery

    with bioactive intraluminal device,

    percutaneous endoscopic approach.

    03VM4DZ.................. Restriction of right external carotid artery

    with intraluminal device, percutaneous

    endoscopic approach.

    03VN0BZ.................. Restriction of left external carotid artery

    with bioactive intraluminal device, open

    approach.

    03VN0DZ.................. Restriction of left external carotid artery

    with intraluminal device, open approach.

    03VN3BZ.................. Restriction of left external carotid artery

    with bioactive intraluminal device,

    percutaneous approach.

    03VN3DZ.................. Restriction of left external carotid artery

    with intraluminal device, percutaneous

    approach.

    03VN4BZ.................. Restriction of left external carotid artery

    with bioactive intraluminal device,

    percutaneous endoscopic approach.

    03VN4DZ.................. Restriction of left external carotid artery

    with intraluminal device, percutaneous

    endoscopic approach.

    03VP0BZ.................. Restriction of right vertebral artery with

    bioactive intraluminal device, open

    approach.

    03VP0DZ.................. Restriction of right vertebral artery with

    intraluminal device, open approach.

    03VP3BZ.................. Restriction of right vertebral artery with

    bioactive intraluminal device, percutaneous

    approach.

    03VP3DZ.................. Restriction of right vertebral artery with

    intraluminal device, percutaneous approach.

    03VP4BZ.................. Restriction of right vertebral artery with

    bioactive intraluminal device, percutaneous

    endoscopic approach.

    03VP4DZ.................. Restriction of right vertebral artery with

    intraluminal device, percutaneous endoscopic

    approach.

    03VQ0BZ.................. Restriction of left vertebral artery with

    bioactive intraluminal device, open

    approach.

    03VQ0DZ.................. Restriction of left vertebral artery with

    intraluminal device, open approach.

    03VQ3BZ.................. Restriction of left vertebral artery with

    bioactive intraluminal device, percutaneous

    approach.

    03VQ3DZ.................. Restriction of left vertebral artery with

    intraluminal device, percutaneous approach.

    03VQ4BZ.................. Restriction of left vertebral artery with

    bioactive intraluminal device, percutaneous

    endoscopic approach.

    03VQ4DZ.................. Restriction of left vertebral artery with

    intraluminal device, percutaneous endoscopic

    approach.

    03VR0DZ.................. Restriction of face artery with intraluminal

    device, open approach.

    03VR3DZ.................. Restriction of face artery with intraluminal

    device, percutaneous approach.

    03VR4DZ.................. Restriction of face artery with intraluminal

    device, percutaneous endoscopic approach.

    03VS0DZ.................. Restriction of right temporal artery with

    intraluminal device, open approach.

    03VS3DZ.................. Restriction of right temporal artery with

    intraluminal device, percutaneous approach.

    03VS4DZ.................. Restriction of right temporal artery with

    intraluminal device, percutaneous endoscopic

    approach.

    03VT0DZ.................. Restriction of left temporal artery with

    intraluminal device, open approach.

    03VT3DZ.................. Restriction of left temporal artery with

    intraluminal device, percutaneous approach.

    03VT4DZ.................. Restriction of left temporal artery with

    intraluminal device, percutaneous endoscopic

    approach.

    03VU0DZ.................. Restriction of right thyroid artery with

    intraluminal device, open approach.

    03VU3DZ.................. Restriction of right thyroid artery with

    intraluminal device, percutaneous approach.

    03VU4DZ.................. Restriction of right thyroid artery with

    intraluminal device, percutaneous endoscopic

    approach.

    03VV0DZ.................. Restriction of left thyroid artery with

    intraluminal device, open approach.

    03VV3DZ.................. Restriction of left thyroid artery with

    intraluminal device, percutaneous approach.

    03VV4DZ.................. Restriction of left thyroid artery with

    intraluminal device, percutaneous endoscopic

    approach.

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

    We examined claims data from the December 2014 update of the FY 2014 MedPAR file for cases with diagnosis code 784.7 reported with procedure codes 39.75 and 39.76 in MS-DRGs 981, 982, and 983. The following table shows our findings.

    Endovascular Embolization Procedures for Epistaxis

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

    Average

    MS-DRG Number of length of Average

    cases stay costs

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

    MS-DRG 981--All cases............ 21,118 12.38 $33,080

    MS-DRG 981--Epistaxis cases with 8 6.50 34,655

    principal diagnosis code 784.7

    and procedure code 39.75........

    MS-DRG 981--Epistaxis cases with 2 12.50 50,081

    principal diagnosis code 784.7

    and procedure code 39.76........

    MS-DRG 982--All cases............ 13,657 7.14 19,392

    MS-DRG 982--Epistaxis cases with 22 3.14 17,725

    principal diagnosis code 784.7

    and procedure code 39.75........

    MS-DRG 982--Epistaxis cases with 2 2.0 11,010

    principal diagnosis code 784.7

    and procedure code 39.76........

    MS-DRG 983--All cases............ 2,989 3.60 12,760

    MS-DRG 983--Epistaxis cases with 5 2.60 10,532

    principal diagnosis code 784.7

    and procedure code 39.75........

    MS-DRG 983--Epistaxis cases with 4 1.50 16,658

    principal diagnosis code 784.7

    and procedure code 39.76........

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

    We found only 35 epistaxis cases with procedure code 39.75 reported and 8 cases with procedure code 39.76 reported among MS-DRGs 981, 982, and 983. The use of endovascular embolizations for epistaxis appears to be rare. The average costs for the cases with procedure code 39.75 in MS-DRGs 981, 982, and 983 are similar to the average costs for all cases in MS-DRGs 981, 982, and 983, respectively. The average costs for the cases with procedure code 39.75 in MS-DRGs 981, 982, and 983 were $34,655, $17,725, and $10,532, respectively, compared to $33,080, $19,392, and $12,760 for all cases in MS-DRGs 981, 982, and 983. The average costs for cases with procedure code 39.76 in MS-DRGs 981, 982, and 983 were $50,081, $11,010, and $16,658, respectively, and were significantly greater than all cases in MS-DRGs 981 and 983. However, as stated earlier, there were only 8 cases reported with procedure code 39.76. As explained previously, MS-DRGs 981, 982, and 983 were created for operating

    Page 49420

    room procedures that are unrelated to the principal diagnosis. Because there were so few cases reported, this does not appear to be a common procedure for epistaxis. There were not enough cases to base a change of MS-DRG assignment for these cases.

    Our clinical advisors reviewed this issue and did not identify any new MS-DRG assignment that would be more appropriate for these rare cases. They advised us to maintain the current MS-DRG structure within MS-DRGs 981, 982, and 983.

    Based on the results of the examination of the claims data and the recommendations from our clinical advisors, in the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24403 through 24405), we did not propose to create new MS-DRG assignments for epistaxis cases receiving endovascular embolization procedures. We proposed to maintain the current MS-DRG structure for epistaxis cases receiving endovascular embolization procedures and did not propose any updates to MS-DRGs 981, 982, and 983. We invited public comments on our proposal.

    Comment: A number of commenters supported the proposal. The commenters stated that the proposal was reasonable, given the data and information provided.

    Response: We appreciate the commenters' support for our proposal.

    After consideration of the public comments we received, we are finalizing our proposal to maintain the current MS-DRG structure for epistaxis cases receiving endovascular embolization procedures and not make any updates to MS-DRGs 981, 982, and 983.

  203. Adding Diagnosis or Procedure Codes to MDCs

    Based on the review of cases in the MDCs, as described above in sections II.G.2. through 7. of the preamble of this final rule, we did not propose to add any diagnosis or procedure codes to MDCs for FY 2016. We invited public comments on our proposal.

    We did not receive any public comments on our proposal and, therefore, are adopting it as final.

    13. Changes to the ICD-9-CM System

  204. ICD-10 Coordination and Maintenance Committee

    In September 1985, the ICD-9-CM Coordination and Maintenance Committee was formed. This is a Federal interdepartmental committee, co-chaired by the National Center for Health Statistics (NCHS), the Centers for Disease Control and Prevention, and CMS, charged with maintaining and updating the ICD-9-CM system. The final update to ICD-

    9-CM codes was to be made on October 1, 2013. Thereafter, the name of the Committee was changed to the ICD-10 Coordination and Maintenance Committee, effective with the March 19-20, 2014 meeting. The ICD-10 Coordination and Maintenance Committee addresses updates to the ICD-10-

    CM, ICD-10-PCS, and ICD-9-CM coding systems. The Committee is jointly responsible for approving coding changes, and developing errata, addenda, and other modifications to the coding systems to reflect newly developed procedures and technologies and newly identified diseases. The Committee is also responsible for promoting the use of Federal and non-Federal educational programs and other communication techniques with a view toward standardizing coding applications and upgrading the quality of the classification system.

    The official list of ICD-9-CM diagnosis and procedure codes by fiscal year can be found on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/codes.html. The official list of ICD-10-CM and ICD-10-PCS codes can be found on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD10/index.html,

    The NCHS has lead responsibility for the ICD-10-CM and ICD-9-CM diagnosis codes included in the Tabular List and Alphabetic Index for Diseases, while CMS has lead responsibility for the ICD-10-PCS and ICD-

    9-CM procedure codes included in the Tabular List and Alphabetic Index for Procedures.

    The Committee encourages participation in the above process by health-related organizations. In this regard, the Committee holds public meetings for discussion of educational issues and proposed coding changes. These meetings provide an opportunity for representatives of recognized organizations in the coding field, such as the American Health Information Management Association (AHIMA), the American Hospital Association (AHA), and various physician specialty groups, as well as individual physicians, health information management professionals, and other members of the public, to contribute ideas on coding matters. After considering the opinions expressed at the public meetings and in writing, the Committee formulates recommendations, which then must be approved by the agencies.

    The Committee presented proposals for coding changes for implementation in FY 2016 at a public meeting held on September 23-24, 2014, and finalized the coding changes after consideration of comments received at the meetings and in writing by November 15, 2014.

    The Committee held its 2015 meeting on March 18-19, 2015. It was announced at this meeting that any new ICD-10-CM/PCS codes for which there was consensus of public support and for which complete tabular and indexing changes would be made by May 2015 would be included in the October 1, 2015 update to ICD-10-CM/ICD-10-PCS. For FY 2016, there are no new, revised, or deleted ICD-10-CM diagnosis codes. For FY 2016, there are new ICD-10-PCS procedure codes that are included in Table 6B (New Procedure Codes). However, there are no revised or deleted ICD-10-

    PCS procedure codes. There also are no new ICD-9-CM diagnosis or procedure codes because ICD-9-CM will be replaced by ICD-10-CM/ICD-10-

    PCS for services provided on or after October 1, 2015.

    Copies of the agenda, handouts, and access to the live stream videos for the procedure codes discussions at the Committee's September 23-24, 2014 meeting and March 18-19, 2015 meeting can be obtained from the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/index.html?redirect=/

    icd9ProviderDiagnosticCodes/03_meetings.asp. The agenda, handouts and minutes of the diagnosis codes discussions at the September 23-24, 2014 meeting and March 18-19, 2015 meeting are found at: http://www.cdc.gov/nchs/icd/icd9cm-maintenance.html. These Web sites also provide detailed information about the Committee, including information on requesting a new code, attending a Committee meeting, timeline requirements and meeting dates.

    We encourage commenters to address suggestions on coding issues involving diagnosis codes to: Donna Pickett, Co-Chairperson, ICD-10 Coordination and Maintenance Committee, NCHS, Room 2402, 3311 Toledo Road, Hyattsville, MD 20782. Comments may be sent by Email to: dfp4@cdc.gov.

    Questions and comments concerning the procedure codes should be addressed to: Patricia Brooks, Co-Chairperson, ICD-10 Coordination and Maintenance Committee, CMS, Center for Medicare, Hospital and Ambulatory Policy Group, Division of Acute Care, C4-08-06, 7500 Security Boulevard, Baltimore, MD 21244-1850. Comments may be sent by Email to: patricia.brooks2@cms.hhs.gov.

    In the September 7, 2001 final rule implementing the IPPS new technology add-on payments (66 FR 46906), we

    Page 49421

    indicated we would attempt to include proposals for procedure codes that would describe new technology discussed and approved at the Spring meeting as part of the code revisions effective the following October.

    Section 503(a) of Public Law 108-173 included a requirement for updating ICD-9-CM codes twice a year instead of a single update on October 1 of each year. This requirement was included as part of the amendments to the Act relating to recognition of new technology under the IPPS. Section 503(a) amended section 1886(d)(5)(K) of the Act by adding a clause (vii) which states that the Secretary shall provide for the addition of new diagnosis and procedure codes on April 1 of each year, but the addition of such codes shall not require the Secretary to adjust the payment (or diagnosis-related group classification) until the fiscal year that begins after such date. This requirement improves the recognition of new technologies under the IPPS system by providing information on these new technologies at an earlier date. Data will be available 6 months earlier than would be possible with updates occurring only once a year on October 1.

    While section 1886(d)(5)(K)(vii) of the Act states that the addition of new diagnosis and procedure codes on April 1 of each year shall not require the Secretary to adjust the payment, or DRG classification, under section 1886(d) of the Act until the fiscal year that begins after such date, we have to update the DRG software and other systems in order to recognize and accept the new codes. We also publicize the code changes and the need for a mid-year systems update by providers to identify the new codes. Hospitals also have to obtain the new code books and encoder updates, and make other system changes in order to identify and report the new codes.

    The ICD-10 (previously the ICD-9-CM) Coordination and Maintenance Committee holds its meetings in the spring and fall in order to update the codes and the applicable payment and reporting systems by October 1 of each year. Items are placed on the agenda for the Committee meeting if the request is received at least 2 months prior to the meeting. This requirement allows time for staff to review and research the coding issues and prepare material for discussion at the meeting. It also allows time for the topic to be publicized in meeting announcements in the Federal Register as well as on the CMS Web site. The public decides whether or not to attend the meeting based on the topics listed on the agenda. Final decisions on code title revisions are currently made by March 1 so that these titles can be included in the IPPS proposed rule. A complete addendum describing details of all diagnosis and procedure coding changes, both tabular and index, is published on the CMS and NCHS Web sites in May of each year. Publishers of coding books and software use this information to modify their products that are used by health care providers. This 5-month time period has proved to be necessary for hospitals and other providers to update their systems.

    A discussion of this timeline and the need for changes are included in the December 4-5, 2005 ICD-9-CM Coordination and Maintenance Committee Meeting minutes. The public agreed that there was a need to hold the fall meetings earlier, in September or October, in order to meet the new implementation dates. The public provided comment that additional time would be needed to update hospital systems and obtain new code books and coding software. There was considerable concern expressed about the impact this new April update would have on providers.

    In the FY 2005 IPPS final rule, we implemented section 1886(d)(5)(K)(vii) of the Act, as added by section 503(a) of Public Law 108-173, by developing a mechanism for approving, in time for the April update, diagnosis and procedure code revisions needed to describe new technologies and medical services for purposes of the new technology add-on payment process. We also established the following process for making these determinations. Topics considered during the Fall ICD-10 (previously ICD-9-CM) Coordination and Maintenance Committee meeting are considered for an April 1 update if a strong and convincing case is made by the requestor at the Committee's public meeting. The request must identify the reason why a new code is needed in April for purposes of the new technology process. The participants at the meeting and those reviewing the Committee meeting summary report are provided the opportunity to comment on this expedited request. All other topics are considered for the October 1 update. Participants at the Committee meeting are encouraged to comment on all such requests. There were no requests approved for an expedited April l, 2015 implementation of a code at the September 23-24, 2014 Committee meeting. Therefore, there were no new codes implemented on April 1, 2015.

    ICD-9-CM addendum and code title information is published on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/index.html?redirect=/

    icd9ProviderDiagnosticCodes/01overview.asp#TopofPage. ICD-10-CM and ICD-10-PCS addendum and code title information is published on the CMS Web site at http://www.cms.gov/Medicare/Coding/ICD10/index.html. Information on ICD-10-CM diagnosis codes, along with the Official ICD-

    10-CM Coding Guidelines, can also be found on the CDC Web site at: http://www.cdc.gov/nchs/index.html. Information on new, revised, and deleted ICD-10-CM/ICD-10-PCS codes is also provided to the AHA for publication in the Coding Clinic for ICD-10. AHA also distributes information to publishers and software vendors.

    CMS also sends copies of all ICD-10-CM and ICD-10-PCS coding changes to its Medicare contractors for use in updating their systems and providing education to providers.

    The code titles are adopted as part of the ICD-10 (previously ICD-

    9-CM) Coordination and Maintenance Committee process. Therefore, although we publish the code titles in the IPPS proposed and final rules, they are not subject to comment in the proposed or final rules.

  205. Code Freeze

    In the January 16, 2009 ICD-10-CM and ICD-10-PCS final rule (74 FR 3340), there was a discussion of the need for a partial or total freeze in the annual updates to both ICD-9-CM and ICD-10-CM and ICD-10-PCS codes. The public comment addressed in that final rule stated that the annual code set updates should cease l year prior to the implementation of ICD-10. The commenters stated that this freeze of code updates would allow for instructional and/or coding software programs to be designed and purchased early, without concern that an upgrade would take place immediately before the compliance date, necessitating additional updates and purchases.

    HHS responded to comments in the ICD-10 final rule that the ICD-9-

    CM Coordination and Maintenance Committee has jurisdiction over any action impacting the ICD-9-CM and ICD-10 code sets. Therefore, HHS indicated that the issue of consideration of a moratorium on updates to the ICD-9-CM, ICD-10-CM, and ICD-10-PCS code sets in anticipation of the adoption of ICD-10-CM and ICD-10-PCS would be addressed through the Committee at a future public meeting.

    The code freeze was discussed at multiple meetings of the ICD-9-CM Coordination and Maintenance

    Page 49422

    Committee and public comment was actively solicited. The Committee evaluated all comments from participants attending the Committee meetings as well as written comments that were received. The Committee also considered the delay in implementation of ICD-10 until October 1, 2014. There was an announcement at the September 19, 2012 ICD-9-CM Coordination and Maintenance Committee meeting that a partial freeze of both ICD-9-CM and ICD-10 codes will be implemented as follows:

    The last regular annual update to both ICD-9-CM and ICD-10 code sets was made on October 1, 2011.

    On October 1, 2012 and October 1, 2013, there were to be only limited code updates to both ICD-9-CM and ICD-10 code sets to capture new technology and new diseases.

    On October 1, 2014, there were to be only limited code updates to ICD-10 code sets to capture new technology and diagnoses as required by section 503(a) of Public Law 108-173. There were to be no updates to ICD-9-CM on October 1, 2014.

    On October 1, 2015, one year after the originally scheduled implementation of ICD-10, regular updates to ICD-10 were to begin.

    On May 15, 2014, CMS posted an updated Partial Code Freeze schedule on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD10/ICD-9-CM-Coordination-and-Maintenance-Committee-Meetings.html. This updated schedule provided information on the extension of the partial code freeze until 1 year after the implementation of ICD-10. As stated earlier, on April 1, 2014, the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93) was enacted, which specified that the Secretary may not adopt ICD-10 prior to October 1, 2015. Accordingly, the U.S. Department of Health and Human Services released a final rule in the Federal Register on August 4, 2014 (79 FR 45128 through 45134) that included a new compliance date that requires the use of ICD-10 beginning October 1, 2015. The August 4, 2014 final rule is available for viewing on the Internet at: http://www.gpo.gov/fdsys/pkg/FR-2014-08-04/pdf/2014-18347.pdf. That final rule also requires HIPAA covered entities to continue to use ICD-9-CM through September 30, 2015. Accordingly, the updated schedule for the partial code freeze is as follows:

    The last regular annual updates to both ICD-9-CM and ICD-

    10 code sets were made on October 1, 2011.

    On October 1, 2012, October 1, 2013, and October 1, 2014, there were only limited code updates to both the ICD-9-CM and ICD-10 code sets to capture new technologies and diseases as required by section 1886(d)(5)(K) of the Act.

    On October 1, 2015, there will be only limited code updates to ICD-10 code sets to capture new technologies and diagnoses as required by section 1886(d)(5)(K) of the Act. There will be no updates to ICD-9-CM, as it will no longer be used for reporting.

    On October 1, 2016 (1 year after implementation of ICD-

    10), regular updates to ICD-10 will begin.

    The ICD-10 (previously ICD-9-CM) Coordination and Maintenance Committee announced that it would continue to meet twice a year during the freeze. At these meetings, the public will be encouraged to comment on whether or not requests for new diagnosis and procedure codes should be created based on the need to capture new technology and new diseases. Any code requests that do not meet the criteria will be evaluated for implementation within ICD-10 one year after the implementation of ICD-10, once the partial freeze is ended.

    Complete information on the partial code freeze and discussions of the issues at the Committee meetings can be found on the ICD-10 Coordination and Maintenance Committee Web site at: http://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/meetings.html. A summary of the September 19, 2012 Committee meeting, along with both written and audio transcripts of this meeting, is posted on the Web site at: http://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/ICD-9-CM-C-and-M-Meeting-Materials-Items/2012-09-19-MeetingMaterials.html.

    This partial code freeze has dramatically decreased the number of codes created each year as shown by the following information.

    Total Number of Codes and Changes in Total Number of Codes per Fiscal Year

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

    ICD-9-CM Codes ICD-10-CM and ICD-10-PCS Codes

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

    Fiscal Year Number Change Fiscal Year Number Change

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

    FY 2009 (October 1, 2008): FY 2009:

    Diagnoses...................... 14,025 348 ICD-10-CM.......... 68,069 +5

    Procedures..................... 3,824 56 ICD-10-PCS......... 72,589 -14,327

    FY 2010 (October 1, 2009): FY 2010:

    Diagnoses...................... 14,315 290 ICD-10-CM.......... 69,099 +1,030

    Procedures..................... 3,838 14 ICD-10-PCS......... 71,957 -632

    FY 2011 (October 1, 2010):

    Diagnoses...................... 14,432 117 ICD-10-CM.......... 69,368 +269

    Procedures..................... 3,859 21 ICD-10-PCS......... 72,081 +124

    FY 2012 (October 1, 2011): FY 2012:

    Diagnoses...................... 14,567 135 ICD-10-CM.......... 69,833 +465

    Procedures..................... 3,877 18 ICD-10-PCS......... 71,918 -163

    FY 2013 (October 1, 2012): FY 2013:

    Diagnoses...................... 14,567 0 ICD-10-CM.......... 69,832 -1

    Procedures..................... 3,878 1 ICD-10-PCS......... 71,920 +2

    FY 2014 (October 1, 2013): FY 2014:

    Diagnoses...................... 14,567 0 ICD-10-CM.......... 69,823 -9

    Procedures..................... 3,882 4 ICD-10-PCS......... 71,924 +4

    FY 2015 (October 1, 2014): FY 2015:

    Diagnoses...................... 14,567 0 ICD-10-CM.......... 69,823 0

    Procedures..................... 3,882 0 ICD-10-PCS......... 71,924 0

    FY 2016 (October 1, 2015): FY 2016:

    Diagnoses...................... 14,567 0 ICD-10-CM.......... 69,823 0

    Procedures..................... 3,882 0 ICD-10-PCS......... 71,974 +50

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

    Page 49423

    As mentioned earlier, the public is provided the opportunity to comment on any requests for new diagnosis or procedure codes discussed at the ICD-10 Coordination and Maintenance Committee meeting. The public has supported only a limited number of new codes during the partial code freeze, as can be seen by data shown above. We have gone from creating several hundred new codes each year to creating only a limited number of new ICD-9-CM and ICD-10 codes.

    At the September 23-24, 2014 and March 18-19, 2015 Committee meetings, we discussed any requests we had received for new ICD-10-CM diagnosis and ICD-10-PCS procedure codes that were to be implemented on October 1, 2015. We did not discuss ICD-9-CM codes. The public was given the opportunity to comment on whether or not new ICD-10-CM and ICD-10-PCS codes should be created, based on the partial code freeze criteria. The public was to use the criteria as to whether codes were needed to capture new diagnoses or new technologies. If the codes do not meet those criteria for implementation during the partial code freeze, consideration was to be given as to whether the codes should be created after the partial code freeze ends 1 year after the implementation of ICD-10-CM/PCS. We invited public comments on any code requests discussed at the September 23-24, 2014 and March 18-19, 2015 Committee meetings for implementation as part of the October 1, 2015 update. The deadline for commenting on code proposals discussed at the September 23-24, 2014 Committee meeting was November 21, 2014. The deadline for commenting on code proposals discussed at the March 18-19, 2015 Committee meeting was April 17, 2015.

    14. Other Policy Changes: Replaced Devices Offered Without Cost or With a Credit

  206. Background

    In the FY 2008 IPPS final rule with comment period (72 FR 47246 through 47251), we discussed the topic of Medicare payment for devices that are replaced without cost or where credit for a replaced device is furnished to the hospital. We implemented a policy to reduce a hospital's IPPS payment for certain MS-DRGs where the implantation of a device that has been recalled determined the base MS-DRG assignment. We specified that if a hospital received a credit for a recalled device equal to 50 percent or more of the cost of the device, we would reduce a hospital's IPPS payment for those MS-DRGs.

    In the FY 2012 IPPS/LTCH PPS final rule (76 FR 51556 and 51557), we clarified this policy to state that the policy applies if the hospital received a credit equal to 50 percent or more of the cost of the replacement device and issued instructions to hospitals accordingly.

  207. Request for Clarification on Policy Relating to ``Device-Dependent'' MS-DRGs

    After publication of the FY 2015 IPPS/LTCH PPS final rule, we received a request to clarify the list of ``device-dependent'' MS-DRGs subject to the policy for payment under the IPPS for replaced devices offered without cost or with a credit. Specifically, a requestor noted that ICD-9-CM procedure codes that previously grouped to MS-DRGs 216 through 221 (Cardiac Valve & Other Major Cardiothoracic Procedure with and without Cardiac Catheterization, with MCC, with CC, without CC/MCC, respectively) and were subject to the policy for payment under the IPPS as ``device-dependent'' MS-DRGs had been reassigned to new MS-DRGs 266 and 267 (Endovascular Cardiac Valve Replacement with MCC and without MCC, respectively). The requestor suggested that MS-DRGs 266 and 267 also should be considered ``device-dependent'' MS-DRGs and added to the list of MS-DRGs subject to the IPPS payment policy for replaced devices offered without cost or with a credit.

    As noted by the requestor, as final policy for FY 2015, certain ICD-9-CM procedure codes that previously grouped to MS-DRGs 216 through 221, which are on the list of MS-DRGs subject to the policy for payment under the IPPS for replaced devices offered without cost or with a credit, were reassigned to MS-DRGs 266 and 267. We agree that MS-DRGs 266 and 267 should be included in the list of ``device-dependent'' MS-

    DRGs subject to the IPPS policy. We generally map new MS-DRGs onto the list when they are formed from procedures previously assigned to MS-

    DRGs that are already on the list. Therefore, in the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24409), we proposed to add MS-DRGs 266 and 267 to the list of ``device dependent'' MS-DRGs subject to the policy for payment under the IPPS for replaced devices offered without cost or with a credit.

    In addition, as discussed in section II.G.4.e. of the preamble of the proposed rule, for FY 2016, we proposed to delete MS-DRGs 237 and 238 (Major Cardiovascular Procedures with MCC and without MCC, respectively) and create new MS-DRGs 268 and 269 (Aortic and Heart Assist Procedures Except Pulsation Balloon with MCC and without MCC, respectively), as well as new MS-DRGs 270, 271, and 272 (Other Major Cardiovascular Procedures with MCC, with CC, and without CC/MCC, respectively). Currently, MS-DRGs 237 and 238 are on the list of MS-

    DRGs subject to the policy for payment under the IPPS for replaced devices offered without cost or with a credit. As stated previously, we generally map new MS-DRGs onto the list when they are formed from procedures previously assigned to MS-DRGs that are already on the list. Therefore, we indicated that if we finalized these proposed MS-DRG changes, we also would add proposed new MS-DRGs 268 through 272 to the list of MS-DRGs subject to the policy for payment under the IPPS for replaced devices offered without cost or with a credit. We invited public comments on our proposed list of MS-DRGs to be subject to the IPPS policy for replaced devices offered without cost or with a credit for FY 2016 (80 FR 24409 through 24410).

    Comment: Commenters supported the proposal to add MS-DRGs 266 and 267 to the list of MS-DRGs subject to the IPPS payment policy for replaced devices offered without cost or with a credit. We did not receive any public comments in response to our proposal to delete ICD-

    9-CM MS-DRGs 237 and 238 and add any of the finalized new ICD-10 MS-

    DRGs to the list.

    Response: We appreciate the commenters' support.

    After consideration of the public comments we received, we are adding MS-DRGs 266 and 267 to the list of MS-DRGs subject to the policy for payment under the IPPS for replaced devices offered without cost or with a credit, and consistent with the applicable finalized MS-DRG changes, also removing existing MS-DRGs 237 and 238 and adding new MS-

    DRGs 268 through 272. The list of MS-DRGs that are subject to the IPPS policy for replaced devices offered without cost or with a credit for FY 2016 is displayed below. We also intend to issue this list to providers in the form of a Change Request (CR).

    Page 49424

    List of MS-DRGs Subject to the IPPS Policy for Replaced Devices Offered

    Without Cost or With a Credit

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

    MDC MS-DRG MS-DRG title

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

    PreMDC..................... 001 Heart Transplant or Implant of

    Heart Assist System with MCC.

    PreMDC..................... 002 Heart Transplant or Implant of

    Heart Assist System without

    MCC.

    MDC 01..................... 023 Craniotomy with Major Device

    Implant/Acute Complex CNS PDX

    with MCC or Chemo Implant.

    MDC 01..................... 024 Craniotomy with Major Device

    Implant/Acute Complex CNS PDX

    without MCC.

    MDC 01..................... 025 Craniotomy & Endovascular

    Intracranial Procedures with

    MCC.

    MDC 01..................... 026 Craniotomy & Endovascular

    Intracranial Procedures with

    CC.

    MDC 01..................... 027 Craniotomy & Endovascular

    Intracranial Procedures without

    CC/MCC.

    MDC 01..................... 040 Peripheral/Cranial Nerve & Other

    Nervous System Procedures with

    MCC.

    MDC 01..................... 041 Peripheral/Cranial Nerve & Other

    Nervous System Procedures with

    CC or Peripheral

    Neurostimulation.

    MDC 01..................... 042 Peripheral/Cranial Nerve & Other

    Nervous System Procedures

    without CC/MCC.

    MDC 03..................... 129 Major Head & Neck Procedures

    with CC/MCC or Major Device.

    MDC 03..................... 130 Major Head & Neck Procedures

    without CC/MCC.

    MDC 05..................... 215 Other Heart Assist System

    Implant.

    MDC 05..................... 216 Cardiac Valve & Other Major

    Cardiothoracic Procedures with

    Cardiac Catheterization with

    MCC.

    MDC 05..................... 217 Cardiac Valve & Other Major

    Cardiothoracic Procedures with

    Cardiac Catheterization with

    CC.

    MDC 05..................... 218 Cardiac Valve & Other Major

    Cardiothoracic Procedures with

    Cardiac Catheterization without

    CC/MCC.

    MDC 05..................... 219 Cardiac Valve & Other Major

    Cardiothoracic Procedures

    without Cardiac Catheterization

    with MCC.

    MDC 05..................... 220 Cardiac Valve & Other Major

    Cardiothoracic Procedures

    without Cardiac Catheterization

    with CC.

    MDC 05..................... 221 Cardiac Valve & Other Major

    Cardiothoracic Procedures

    without Cardiac Catheterization

    without CC/MCC.

    MDC 05..................... 222 Cardiac Defibrillator Implant

    with Cardiac Catheterization

    with AMI/HF/Shock with MCC.

    MDC 05..................... 223 Cardiac Defibrillator Implant

    with Cardiac Catheterization

    with AMI/HF/Shock without MCC.

    MDC 05..................... 224 Cardiac Defibrillator Implant

    with Cardiac Catheterization

    without AMI/HF/Shock with MCC.

    MDC 05..................... 225 Cardiac Defibrillator Implant

    with Cardiac Catheterization

    without AMI/HF/Shock without

    MCC.

    MDC 05..................... 226 Cardiac Defibrillator Implant

    without Cardiac Catheterization

    with MCC.

    MDC 05..................... 227 Cardiac Defibrillator Implant

    without Cardiac Catheterization

    without MCC.

    MDC 05..................... 242 Permanent Cardiac Pacemaker

    Implant with MCC.

    MDC 05..................... 243 Permanent Cardiac Pacemaker

    Implant with CC.

    MDC 05..................... 244 Permanent Cardiac Pacemaker

    Implant without CC/MCC.

    MDC 05..................... 245 AICD Generator Procedures.

    MDC 05..................... 258 Cardiac Pacemaker Device

    Replacement with MCC.

    MDC 05..................... 259 Cardiac Pacemaker Device

    Replacement without MCC.

    MDC 05..................... 260 Cardiac Pacemaker Revision

    Except Device Replacement with

    MCC.

    MDC 05..................... 261 Cardiac Pacemaker Revision

    Except Device Replacement with

    CC.

    MDC 05..................... 262 Cardiac Pacemaker Revision

    Except Device Replacement

    without CC/MCC.

    MDC 05..................... 265 AICD Lead Procedures.

    MDC 05..................... 266 Endovascular Cardiac Valve

    Replacement with MCC.

    MDC 05..................... 267 Endovascular Cardiac Valve

    Replacement without MCC.

    MDC 05..................... 268 Aortic and Heart Assist

    Procedures Except Pulsation

    Balloon with MCC.

    MDC 05..................... 269 Aortic and Heart Assist

    Procedures Except Pulsation

    Balloon without MCC.

    MDC 05..................... 270 Other Major Cardiovascular

    Procedures with MCC.

    MDC 05..................... 271 Other Major Cardiovascular

    Procedures with CC.

    MDC 05..................... 272 Other Major Cardiovascular

    Procedures without CC/MCC.

    MDC 08..................... 461 Bilateral or Multiple Major

    Joint Procedures of Lower

    Extremity with MCC.

    MDC 08..................... 462 Bilateral or Multiple Major

    Joint Procedures of Lower

    Extremity without MCC.

    MDC 08..................... 466 Revision of Hip or Knee

    Replacement with MCC.

    MDC 08..................... 467 Revision of Hip or Knee

    Replacement with CC.

    MDC 08..................... 468 Revision of Hip or Knee

    Replacement without CC/MCC.

    MDC 08..................... 469 Major Joint Replacement or

    Reattachment of Lower Extremity

    with MCC.

    MDC 08..................... 470 Major Joint Replacement or

    Reattachment of Lower Extremity

    without MCC.

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

    15. Out of Scope Public Comments

    We received public comments regarding two MS-DRG issues that were outside of the scope of the proposals included in the FY 2016 IPPS/LTCH proposed rule. These comments were as follows:

    Several commenters requested the creation of a new MS-DRG for primary total ankle replacements and revisions of total ankle replacement procedures.

    Several commenters requested the creation of a new MS-DRG for hip fractures for individuals who receive total hip replacements.

    However, because we consider these public comments to be outside of the scope of the proposed rule, we are not addressing them in this final rule. As stated in section II.G.1.b. of the preamble of this final rule, we encourage individuals with comments about MS-DRG classification to submit these comments no later than December 7 of each year so that they can be considered for possible inclusion in the annual proposed rule and, if included, may be subjected to public review and comment. We will consider these public comments for possible proposals in future rulemaking as part of our annual review process.

    H. Recalibration of the FY 2016 MS-DRG Relative Weights

    1. Data Sources for Developing the Relative Weights

    In developing the FY 2016 system of weights, we used two data sources: claims data and cost report data. As in previous years, the claims data source is the MedPAR file. This file is based on fully coded diagnostic and procedure data for all Medicare inpatient hospital bills. The FY 2014 MedPAR data used in this final rule include discharges occurring on October 1, 2013, through September 30, 2014, based on bills received by CMS through March 31,

    Page 49425

    2015, from all hospitals subject to the IPPS and short-term, acute care hospitals in Maryland (which at that time were under a waiver from the IPPS). The FY 2014 MedPAR file used in calculating the relative weights includes data for approximately 9,682,319 Medicare discharges from IPPS providers. Discharges for Medicare beneficiaries enrolled in a Medicare Advantage managed care plan are excluded from this analysis. These discharges are excluded when the MedPAR ``GHO Paid'' indicator field on the claim record is equal to ``1'' or when the MedPAR DRG payment field, which represents the total payment for the claim, is equal to the MedPAR ``Indirect Medical Education (IME)'' payment field, indicating that the claim was an ``IME only'' claim submitted by a teaching hospital on behalf of a beneficiary enrolled in a Medicare Advantage managed care plan. In addition, the March 31, 2015 update of the FY 2014 MedPAR file complies with version 5010 of the X12 HIPAA Transaction and Code Set Standards, and includes a variable called ``claim type.'' Claim type ``60'' indicates that the claim was an inpatient claim paid as fee-for-service. Claim types ``61,'' ``62,'' ``63,'' and ``64'' relate to encounter claims, Medicare Advantage IME claims, and HMO no-pay claims. Therefore, the calculation of the relative weights for FY 2016 also excludes claims with claim type values not equal to ``60.'' The data exclude CAHs, including hospitals that subsequently became CAHs after the period from which the data were taken. We note that the FY 2016 relative weights are based on the ICD-

    9-CM diagnoses and procedures codes from the MedPAR claims data, grouped through the ICD-9-CM version of the FY 2016 GROUPER (Version 33).

    The second data source used in the cost-based relative weighting methodology is the Medicare cost report data files from the HCRIS. Normally, we use the HCRIS dataset that is 3 years prior to the IPPS fiscal year. Specifically, we used cost report data from the March 31, 2015 update of the FY 2013 HCRIS for calculating the FY 2016 cost-based relative weights.

    2. Methodology for Calculation of the Relative Weights

    As we explain in section II.E.2. of the preamble of this final rule, we calculated the FY 2016 relative weights based on 19 CCRs, as we did for FY 2015. The methodology we used to calculate the FY 2016 MS-DRG cost-based relative weights based on claims data in the FY 2014 MedPAR file and data from the FY 2013 Medicare cost reports is as follows:

    To the extent possible, all the claims were regrouped using the FY 2016 MS-DRG classifications discussed in sections II.B. and II.G. of the preamble of this final rule.

    The transplant cases that were used to establish the relative weights for heart and heart-lung, liver and/or intestinal, and lung transplants (MS-DRGs 001, 002, 005, 006, and 007, respectively) were limited to those Medicare-approved transplant centers that have cases in the FY 2014 MedPAR file. (Medicare coverage for heart, heart-

    lung, liver and/or intestinal, and lung transplants is limited to those facilities that have received approval from CMS as transplant centers.)

    Organ acquisition costs for kidney, heart, heart-lung, liver, lung, pancreas, and intestinal (or multivisceral organs) transplants continue to be paid on a reasonable cost basis. Because these acquisition costs are paid separately from the prospective payment rate, it is necessary to subtract the acquisition charges from the total charges on each transplant bill that showed acquisition charges before computing the average cost for each MS-DRG and before eliminating statistical outliers.

    Claims with total charges or total lengths of stay less than or equal to zero were deleted. Claims that had an amount in the total charge field that differed by more than $10.00 from the sum of the routine day charges, intensive care charges, pharmacy charges, special equipment charges, therapy services charges, operating room charges, cardiology charges, laboratory charges, radiology charges, other service charges, labor and delivery charges, inhalation therapy charges, emergency room charges, blood charges, and anesthesia charges were also deleted.

    At least 92.1 percent of the providers in the MedPAR file had charges for 14 of the 19 cost centers. All claims of providers that did not have charges greater than zero for at least 14 of the 19 cost centers were deleted. In other words, a provider must have no more than five blank cost centers. If a provider did not have charges greater than zero in more than five cost centers, the claims for the provider were deleted.

    Statistical outliers were eliminated by removing all cases that were beyond 3.0 standard deviations from the geometric mean of the log distribution of both the total charges per case and the total charges per day for each MS-DRG.

    Effective October 1, 2008, because hospital inpatient claims include a POA indicator field for each diagnosis present on the claim, only for purposes of relative weight-setting, the POA indicator field was reset to ``Y'' for ``Yes'' for all claims that otherwise have an ``N'' (No) or a ``U'' (documentation insufficient to determine if the condition was present at the time of inpatient admission) in the POA field.

    Under current payment policy, the presence of specific HAC codes, as indicated by the POA field values, can generate a lower payment for the claim. Specifically, if the particular condition is present on admission (that is, a ``Y'' indicator is associated with the diagnosis on the claim), it is not a HAC, and the hospital is paid for the higher severity (and, therefore, the higher weighted MS-DRG). If the particular condition is not present on admission (that is, an ``N'' indicator is associated with the diagnosis on the claim) and there are no other complicating conditions, the DRG GROUPER assigns the claim to a lower severity (and, therefore, the lower weighted MS-DRG) as a penalty for allowing a Medicare inpatient to contract a HAC. While the POA reporting meets policy goals of encouraging quality care and generates program savings, it presents an issue for the relative weight-setting process. Because cases identified as HACs are likely to be more complex than similar cases that are not identified as HACs, the charges associated with HAC cases are likely to be higher as well. Therefore, if the higher charges of these HAC claims are grouped into lower severity MS-DRGs prior to the relative weight-setting process, the relative weights of these particular MS-DRGs would become artificially inflated, potentially skewing the relative weights. In addition, we want to protect the integrity of the budget neutrality process by ensuring that, in estimating payments, no increase to the standardized amount occurs as a result of lower overall payments in a previous year that stem from using weights and case-mix that are based on lower severity MS-DRG assignments. If this would occur, the anticipated cost savings from the HAC policy would be lost.

    To avoid these problems, we reset the POA indicator field to ``Y'' only for relative weight-setting purposes for all claims that otherwise have an ``N'' or a ``U'' in the POA field. This resetting ``forced'' the more costly HAC claims into the higher severity MS-DRGs as appropriate, and the relative weights calculated for each MS-DRG more closely reflect the true costs of those cases.

    Page 49426

    In addition, in the FY 2013 IPPS/LTCH PPS final rule, for FY 2013 and subsequent fiscal years, we finalized a policy to treat hospitals that participate in the Bundled Payments for Care Improvement (BPCI) initiative the same as prior fiscal years for the IPPS payment modeling and ratesetting process without regard to hospitals' participation within these bundled payment models (that is, as if hospitals were not participating in those models under the BPCI initiative). The BPCI initiative, developed under the authority of section 3021 of the Affordable Care Act (codified at section 1115A of the Act), is comprised of four broadly defined models of care, which link payments for multiple services beneficiaries receive during an episode of care. Under the BPCI initiative, organizations enter into payment arrangements that include financial and performance accountability for episodes of care. For FY 2016, as we proposed, we are continuing to include all applicable data from subsection (d) hospitals participating in BPCI Models 1, 2, and 4 in our IPPS payment modeling and ratesetting calculations. We refer readers to the FY 2013 IPPS/LTCH PPS final rule for a complete discussion on our final policy for the treatment of hospitals participating in the BPCI initiative in our ratesetting process. For additional information on the BPCI initiative, we refer readers to the CMS' Center for Medicare and Medicaid Innovation's Web site at: http://innovation.cms.gov/initiatives/Bundled-Payments/index.html and to section IV.H.4. of the preamble of the FY 2013 IPPS/

    LTCH PPS final rule (77 FR 53341 through 53343).

    Once the MedPAR data were trimmed and the statistical outliers were removed, the charges for each of the 19 cost groups for each claim were standardized to remove the effects of differences in area wage levels, IME and DSH payments, and for hospitals located in Alaska and Hawaii, the applicable cost-of-living adjustment. Because hospital charges include charges for both operating and capital costs, we standardized total charges to remove the effects of differences in geographic adjustment factors, cost-of-living adjustments, and DSH payments under the capital IPPS as well. Charges were then summed by MS-DRG for each of the 19 cost groups so that each MS-DRG had 19 standardized charge totals. These charges were then adjusted to cost by applying the national average CCRs developed from the FY 2013 cost report data.

    The 19 cost centers that we used in the relative weight calculation are shown in the following table. The table shows the lines on the cost report and the corresponding revenue codes that we used to create the 19 national cost center CCRs.

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

    Medicare charges

    Revenue codes Cost from HCRIS Charges from HCRIS from HCRIS

    Cost center group name (19 MedPAR charge contained in Cost report line (Worksheet C, Part (Worksheet C, Part (Worksheet

    total) field MedPAR charge description 1, Column 5 and line 1, Columns 6 and 7 Ddash3, Column

    field number) Form CMS- and line number) and line number)

    2552-10 Form CMS-2552-10 Form CMS-2552-10

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

    Routine Days.................. Private Room 011X and 014X.... Adults & C_1_C5_30 C_1_C6_30 D3_HOS_C2_30

    Charges. Pediatrics

    (General Routine

    Care).

    Semi-Private Room 012X, 013X and

    Charges. 016X-019X

    Ward Charges..... 015X

    Intensive Days................ Intensive Care 020X............. Intensive Care C_1_C5_31 C_1_C6_31 D3_HOS_C2_31

    Charges. Unit.

    Coronary Care 021X............. Coronary Care C_1_C5_32 C_1_C6_32 D3_HOS_C2_32

    Charges. Unit.

    Burn Intensive C_1_C5_33 C_1_C6_33 D3_HOS_C2_33

    Care Unit.

    Surgical C_1_C5_34 C_1_C6_34 D3_HOS_C2_34

    Intensive Care

    Unit.

    Other Special C_1_C5_35 C_1_C6_35 D3_HOS_C2_35

    Care Unit.

    Drugs......................... Pharmacy Charges. 025X, 026X and Intravenous C_1_C5_64 C_1_C6_64 D3_HOS_C2_64

    063X. Therapy.

    C_1_C7_64

    Drugs Charged To C_1_C5_73 C_1_C6_73 D3_HOS_C2_73

    Patient.

    C_1_C7_73

    Supplies and Equipment........ Medical/Surgical 0270, 0271, 0272, Medical Supplies C_1_C5_71 C_1_C6_71 D3_HOS_C2_71

    Supply Charges. 0273, 0274, Charged to

    0277, 0279, and Patients.

    0621, 0622, 0623.

    C_1_C7_71

    Durable Medical 0290, 0291, 0292 DME-Rented....... C_1_C5_96 C_1_C6_96 D3_HOS_C2_96

    Equipment and 0294-0299.

    Charges.

    C_1_C7_96

    Used Durable 0293............. DME-Sold......... C_1_C5_97 C_1_C6_97 D3_HOS_C2_97

    Medical Charges.

    C_1_C7_97

    Implantable Devices........... ................. 0275, 0276, 0278, Implantable C_1_C5_72 C_1_C6_72 D3_HOS_C2_72

    0624. Devices Charged

    to Patients.

    C_1_C7_72

    Page 49427

    Therapy Services.............. Physical Therapy 042X............. Physical Therapy. C_1_C5_66 C_1_C6_66 D3_HOS_C2_66

    Charges.

    C_1_C7_66

    Occupational 043X............. Occupational C_1_C5_67 C_1_C6_67 D3_HOS_C2_67

    Therapy Charges. Therapy.

    C_1_C7_67

    Speech Pathology 044X and 047X.... Speech Pathology. C_1_C5_68 C_1_C6_68 D3_HOS_C2_68

    Charges.

    C_1_C7_68

    Inhalation Therapy............ Inhalation 041X and 046X.... Respiratory C_1_C5_65 C_1_C6_65 D3_HOS_C2_65

    Therapy Charges. Therapy.

    C_1_C7_65

    Operating Room................ Operating Room 036X............. Operating Room... C_1_C5_50 C_1_C6_50 D3_HOS_C2_50

    Charges.

    C_1_C7_50

    071X............. Recovery Room.... C_1_C5_51 C_1_C6_51 D3_HOS_C2_51

    C_1_C7_51

    Labor & Delivery.............. Operating Room 072X............. Delivery Room and C_1_C5_52 C_1_C6_52 D3_HOS_C2_52

    Charges. Labor Room.

    C_1_C7_52

    Anesthesia.................... Anesthesia 037X............. Anes thesi ology. C_1_C5_53 C_1_C6_53 D3_HOS_C2_53

    Charges.

    C_1_C7_53

    Cardiology.................... Cardiology 048X and 073X.... Electro C_1_C5_69 C_1_C6_69 D3_HOS_C2_69

    Charges. cardiology.

    C_1_C7_69

    Cardiac Catheteri zation...... ................. 0481............. Cardiac Catheteri C_1_C5_59 C_1_C6_59 D3_HOS_C2_59

    zation.

    C_1_C7_59

    Laboratory.................... Laboratory 030X, 031X, and Laboratory....... C_1_C5_60 C_1_C6_60 D3_HOS_C2_60

    Charges. 075X.

    C_1_C7_60

    PBP Clinic C_1_C5_61 C_1_C6_61 D3_HOS_C2_61

    Laboratory

    Services.

    C_1_C7_61

    074X, 086X....... Electro-Enceph C_1_C5_70 C_1_C6_70 D3_HOS_C2_70

    alography.

    C_1_C7_70

    Radiology..................... Radiology Charges 032X, 040X....... Radiology--Diagno C_1_C5_54 C_1_C6_54 D3_HOS_C2_54

    stic.

    C_1_C7_54

    028x, 0331, 0332, Radiology--Therap C_1_C5_55 C_1_C6_55 D3_HOS_C2_55

    0333, 0335, eutic.

    0339, 0342.

    0343 and 344..... Radioisotope..... C_1_C5_56 C_1_C6_56 D3_HOS_C2_56

    C_1_C7_56

    Computed Tomography (CT) Scan. CT Scan Charges.. 035X............. Computed C_1_C5_57 C_1_C6_57 D3_HOS_C2_57

    Tomography (CT)

    Scan.

    C_1_C7_57

    Magnetic Resonance Imaging MRI Charges...... 061X............. Magnetic C_1_C5_58 C_1_C6_58 D3_HOS_C2_58

    (MRI). Resonance

    Imaging (MRI).

    C_1_C7_58

    Emergency Room................ Emergency Room 045x............. Emergency........ C_1_C5_91 C_1_C6_91 D3_HOS_C2_91

    Charges.

    C_1_C7_91

    Blood and Blood Products...... Blood Charges.... 038x............. Whole Blood & C_1_C5_62 C_1_C6_62 D3_HOS_C2_62

    Packed Red Blood

    Cells.

    0819 (for C_1_C7_62

    acquisition

    charges

    associated with

    MS-DRG 014 only).

    Blood Storage/ 039x............. Blood Storing, C_1_C5_63 C_1_C6_63 D3_HOS_C2_63

    Processing. Processing, &

    Transfusing.

    C_1_C7_63

    Page 49428

    Other Services................ Other Service 0002-0099, 022X,

    Charge. 023X,

    024X,052X,053X.

    055X-060X, 064X-

    070X, 076X-078X,

    090X-095X and

    099X.

    Renal Dialysis... 0800X............ Renal Dialysis... C_1_C5_74 C_1_C6_74 D3_HOS_C2_74

    ESRD Revenue 080X and 082X- C_1_C7_74

    Setting Charges. 088X.

    Home Program C_1_C5_94 C_1_C6_94 D3_HOS_C2_94

    Dialysis.

    C_1_C7_94

    Outpatient 049X............. ASC (Non Distinct C_1_C5_75 C_1_C6_75 D3_HOS_C2_75

    Service Charges. Part).

    Lithotripsy 079X............. C_1_C7_75

    Charge.

    Other Ancillary.. C_1_C5_76 C_1_C6_76 D3_HOS_C2_76

    C_1_C7_76

    Clinic Visit 051X............. Clinic........... C_1_C5_90 C_1_C6_90 D3_HOS_C2_90

    Charges.

    C_1_C7_90

    Observation beds. C_1_C5_92.01 C_1_C6_92.01 D3_HOS_C2_92.01

    C_1_C7_92.01

    Professional Fees 096X, 097X, and Other Outpatient C_1_C5_93 C_1_C6_93 D3_HOS_C2_93

    Charges. 098X. Services.

    C_1_C7_93

    Ambulance Charges 054X............. Ambulance........ C_1_C5_95 C_1_C6_95 D3_HOS_C2_95

    C_1_C7_95

    Rural Health C_1_C5_88 C_1_C6_88 D3_HOS_C2_88

    Clinic.

    C_1_C7_88

    FQHC............. C_1_C5_89 C_1_C6_89 D3_HOS_C2_89

    C_1_C7_89

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

    We refer readers to the FY 2009 IPPS/LTCH PPS final rule (73 FR 48462) for a discussion on the revenue codes included in the Supplies and Equipment and Implantable Devices CCRs, respectively.

    3. Development of National Average CCRs

    We developed the national average CCRs as follows:

    Using the FY 2013 cost report data, we removed CAHs, Indian Health Service hospitals, all-inclusive rate hospitals, and cost reports that represented time periods of less than 1 year (365 days). We included hospitals located in Maryland because we include their charges in our claims database. We then created CCRs for each provider for each cost center (see prior table for line items used in the calculations) and removed any CCRs that were greater than 10 or less than 0.01. We normalized the departmental CCRs by dividing the CCR for each department by the total CCR for the hospital for the purpose of trimming the data. We then took the logs of the normalized cost center CCRs and removed any cost center CCRs where the log of the cost center CCR was greater or less than the mean log plus/minus 3 times the standard deviation for the log of that cost center CCR. Once the cost report data were trimmed, we calculated a Medicare-specific CCR. The Medicare-specific CCR was determined by taking the Medicare charges for each line item from Worksheet D-3 and deriving the Medicare-specific costs by applying the hospital-specific departmental CCRs to the Medicare-specific charges for each line item from Worksheet D-3. Once each hospital's Medicare-specific costs were established, we summed the total Medicare-specific costs and divided by the sum of the total Medicare-specific charges to produce national average, charge-weighted CCRs.

    After we multiplied the total charges for each MS-DRG in each of the 19 cost centers by the corresponding national average CCR, we summed the 19 ``costs'' across each MS-DRG to produce a total standardized cost for the MS-DRG. The average standardized cost for each MS-DRG was then computed as the total standardized cost for the MS-DRG divided by the transfer-adjusted case count for the MS-DRG. The average cost for each MS-DRG was then divided by the national average standardized cost per case to determine the relative weight.

    The FY 2016 cost-based relative weights were then normalized by an adjustment factor of 1.678947 so that the average case weight after recalibration was equal to the average case weight before recalibration. The normalization adjustment is intended to ensure that recalibration by itself neither increases nor decreases total payments under the IPPS, as required by section 1886(d)(4)(C)(iii) of the Act.

    The 19 national average CCRs for FY 2016 are as follows:

    Page 49429

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

    Group CCR

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

    Routine Days............................................... 0.480

    Intensive Days............................................. 0.393

    Drugs...................................................... 0.191

    Supplies & Equipment....................................... 0.297

    Implantable Devices........................................ 0.337

    Therapy Services........................................... 0.332

    Laboratory................................................. 0.125

    Operating Room............................................. 0.199

    Cardiology................................................. 0.118

    Cardiac Catheterization.................................... 0.124

    Radiology.................................................. 0.159

    MRIs....................................................... 0.085

    CT Scans................................................... 0.041

    Emergency Room............................................. 0.183

    Blood and Blood Products................................... 0.336

    Other Services............................................. 0.368

    Labor & Delivery........................................... 0.404

    Inhalation Therapy......................................... 0.177

    Anesthesia................................................. 0.106

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

    Since FY 2009, the relative weights have been based on 100 percent cost weights based on our MS-DRG grouping system.

    When we recalibrated the DRG weights for previous years, we set a threshold of 10 cases as the minimum number of cases required to compute a reasonable weight. In the FY 2016 IPPS/LTCH PPS proposed rule, we proposed to use that same case threshold in recalibrating the MS-DRG relative weights for FY 2016. In the FY 2016 IPPS/LTCH PPS proposed rule, we stated that, using data from the FY 2014 MedPAR file, there were 8 MS-DRGs that contain fewer than 10 cases (80 FR 24414). However, we mistakenly included MS-DRG 768 (Vaginal Delivery with O.R. Procedure Except Sterilization and/or D&C) as a low-volume MS-DRG, which, using data from the December 2014 update of the FY 2014 MedPAR file, had more than 10 cases. For this final rule, using data from the March 2015 update of the FY 2014 MedPAR file, there continue to be 7 MS-DRGs that contain fewer than 10 cases, as reflected in the table below. Under the MS-DRGs, we have fewer low-volume DRGs than under the CMS DRGs because we no longer have separate MS-DRGs for patients aged 0 to 17 years. With the exception of newborns, we previously separated some MS-DRGs based on whether the patient was age 0 to 17 years or age 17 years and older. Other than the age split, cases grouping to these MS-DRGs are identical. The MS-DRGs for patients aged 0 to 17 years generally have very low volumes because children are typically ineligible for Medicare. In the past, we have found that the low volume of cases for the pediatric MS-DRGs could lead to significant year-to-

    year instability in their relative weights. Although we have always encouraged non-Medicare payers to develop weights applicable to their own patient populations, we have received frequent complaints from providers about the use of the Medicare relative weights in the pediatric population. We believe that eliminating this age split in the MS-DRGs will provide more stable payment for pediatric cases by determining their payment using adult cases that are much higher in total volume. Newborns are unique and require separate MS-DRGs that are not mirrored in the adult population. Therefore, it remains necessary to retain separate MS-DRGs for newborns. All of the low-volume MS-DRGs listed below are for newborns. For FY 2016, because we do not have sufficient MedPAR data to set accurate and stable cost relative weights for the following low-volume MS-DRGs, as we proposed, we computed relative weights for the low-volume MS-DRGs by adjusting their final FY 2015 relative weights by the percentage change in the average weight of the cases in other MS-DRGs. The crosswalk table is shown below:

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

    Low-volume MS-DRG MS-DRG Title Crosswalk to MS-DRG

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

    789...................... Neonates, Died or Final FY 2015 relative

    Transferred to weight (adjusted by

    Another Acute Care percent change in

    Facility. average weight of the

    cases in other MS-

    DRGs).

    790...................... Extreme Immaturity Final FY 2015 relative

    or Respiratory weight (adjusted by

    Distress Syndrome, percent change in

    Neonate. average weight of the

    cases in other MS-

    DRGs).

    791...................... Prematurity with Final FY 2015 relative

    Major Problems. weight (adjusted by

    percent change in

    average weight of the

    cases in other MS-

    DRGs).

    792...................... Prematurity without Final FY 2015 relative

    Major Problems. weight (adjusted by

    percent change in

    average weight of the

    cases in other MS-

    DRGs).

    793...................... Full-Term Neonate Final FY 2015 relative

    with Major weight (adjusted by

    Problems. percent change in

    average weight of the

    cases in other MS-

    DRGs).

    794...................... Neonate with Other Final FY 2015 relative

    Significant weight (adjusted by

    Problems. percent change in

    average weight of the

    cases in other MS

    DRGs).

    795...................... Normal Newborn..... Final FY 2015 relative

    weight (adjusted by

    percent change in

    average weight of the

    cases in other MS-

    DRGs).

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

    Comment: One commenter stated that the relative weight for MS-DRG 014 (Allogeneic Bone Marrow Transplant) may be understated due to the omission of costs and charges associated with revenue code 0819 which was not included in column 3 of the table of cost report lines and revenue codes on pages 24412 and 24413 of the FY 2016 IPPS/LTCH PPS proposed rule. This commenter also noted that, in the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24411), CMS removes claims from the relative weight calculation that had an amount in the total charge field that differed by more than $10 from the sum of the routine day charges, intensive care charges, pharmacy charges, special equipment charges, therapy services charges, operating room charges, cardiology charges, laboratory charges, radiology charges, other service charges, labor and delivery charges, inhalation therapy charges, emergency room charges, blood charges, and anesthesia charges. The commenter asserted that if revenue code 0819 is not included in the mapped charges, a difference of greater than $10 would always result on any claim with revenue code 0819, causing the claims with revenue code 0819 to be deleted from the dataset, and the relative weight for MS-DRG 014 to be understated. Another commenter noted that, in response to its question in the past regarding the absence of revenue code 0819 from the cost centers crosswalk table, CMS had indicated that the national Blood and Blood Products CCR is what is used to reduce revenue code 0819 line item charges to costs on inpatient claims. The commenter believed this should be reflected in the table in the final rule so that hospitals are able to use this information to evaluate their internal cost reporting practices. The commenter also mentioned the variability in cost reporting among hospitals related to the Blood and Blood Products cost centers, and noted that some hospitals report

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    costs and charges related to stem cell transplantation on lines 62 or 63 of the Medicare cost report Form CMS-2552-10, while other hospitals report these costs and charges on line 112, ``Other Organ Acquisition''. The commenter asserted that CMS' use of a cost center group that may have no relation to where and how donor related charges and costs are actually being captured by providers could be one explanation for why the payment rate for MS-DRG 014 does not appropriately account for all donor related costs incurred by providers who perform stem cell transplantations. The commenter expressed hope that, as CMS reviews the use of nonstandard and subscripted cost centers, it also will undertake a review of where and how SCT charges and costs associated with donor related services reported through revenue code 0819 are being accounted for by hospitals in the cost reports. The commenter also was concerned there are no donor source codes in the ICD-10-PCS coding system and urged CMS to address this matter as soon as possible so that provider reporting of donor source codes is not interrupted with the implementation of ICD-10.

    Response: Section 90.3.3.A.1 of Chapter 3 of the Medicare Claims Processing Manual states that payment for acquisition services associated with allogeneic stem cell transplants is included in the MS-

    DRG payment for the allogeneic stem cell transplant when the transplant occurs in the inpatient setting. The MAC will not make separate payment for these acquisition services because hospitals may bill and receive payment only for services provided to a Medicare beneficiary who is the recipient of the stem cell transplant and whose illness is being treated with the stem cell transplant. Unlike the acquisition costs of solid organs for transplant (for example, hearts and kidneys), which are paid on a reasonable cost basis, acquisition costs for allogeneic stem cells are included in the prospective payment. We note that, in each proposed and final IPPS rule, in the description of the calculation of the MS-DRG relative weights, we state that organ acquisition costs are paid on a reasonable cost basis, and therefore, we deduct the acquisition charges from the total charges on each transplant bill that showed acquisition charges before computing the average cost for each MS-DRG. (We refer readers to the FY 2016 IPPS/

    LTCH PPS proposed rule 80 FR 24410 through 24411.) Under section 90.3.3.A.2 of the Medicare Claims Processing Manual, hospitals are to identify stem cell acquisition charges for allogeneic bone marrow/stem cell transplants separately by using revenue code 0819 (Other Organ Acquisition).

    Accordingly, charges for allogeneic bone marrow transplants are, in fact, included in the MS-DRG relative weights calculation, in the ``Blood and Blood Products'' CCR. That is, for claims that group into MS-DRG 014, CMS includes the acquisition charges in the blood charges and uses the Blood and Blood Products CCR to adjust those charges to cost. Therefore, contrary to the concern expressed by the first commenter, the relative weight for MS-DRG 014 does reflect costs and charges associated with revenue code 0819, and claims containing revenue code 0819 are not systematically deleted from the dataset. In this final rule and for subsequent rules, we are modifying the crosswalk table for the entry of the Blood and Blood Products cost center group to include revenue code 0819, but we are specifying that only the charges associated with MS-DRG 014 are mapped to the Blood and Blood Products cost center. We are continuing to exclude other 081x revenue codes from the crosswalk table, as these codes are associated with Organ Acquisition, which are otherwise excluded from the relative weights calculation because, as explained above, organ acquisition costs are paid on a reasonable cost basis and not under the prospective payment rate.

    Regarding the comment which stated that some hospitals report costs and charges related to stem cell transplantation on lines 62 or 63 of the Medicare cost report Form CMS-2552-10, while other hospitals report these costs and charges on line 112, ``Other Organ Acquisition,'' we note that because the charges associated with revenue code 0819 are being mapped by CMS to the Blood and Blood Products cost centers from line 62 (Whole Blood and Packed Red Blood Cells) and line 63 (Blood Storing, Processing, and Transfusions), the appropriate cost centers for hospitals to report the attending costs of allogeneic bone marrow/

    stem cell transplants are lines 62 and 63 of CMS Form-2552-10. (The cost report instructions for Worksheet A in the Provider Reimbursement Manual (PRM), Part II (Pub. 15-2, Chapter 40, Section 4013, state that hospitals are to include on line 62 ``the direct expenses incurred in obtaining blood directly from donors as well as obtaining whole blood, packed red blood cells, and blood derivatives,'' and ``the processing fee charged by suppliers.'' We also note that line 112, along with the other organ transplant lines 105 through 111, are excluded from the calculation of the CCRs and the IPPS relative weights (and therefore are not listed on the crosswalk table). Consequently, any costs related to charges billed under revenue code 0819 that are reported on line 112 would not be captured in the MS-DRG relative weight calculations.

    Regarding the commenter's concern that donor related costs are not being properly reported on the Medicare cost report, and that CMS should undertake a review of where and how donor related services reported through revenue code 0819 are being accounted for by hospitals on the cost reports, we believe this is related to overall inconsistencies in cost reporting, particularly with nonstandard cost centers, which we discuss in section II.E.2. of this final rule. As we state in response to comments received in that section, we appreciate the comments that stakeholders have submitted and will continue to explore ways in which CMS can improve the accuracy of the cost report data and the calculation of CCRs used in the cost estimation process. To the extent possible, we will continue to seek stakeholder input in an effort to limit the impact on hospitals.

    Regarding the commenter's concerns that there are no donor source codes under ICD-10-PCS, we note that the donor source is an integral part of all transplant and transfusion codes within ICD-10-PCS. Donor source information is captured in the seventh character qualifiers. For example, the root term ``Transplantation'' provides the following seventh character qualifier values as options to describe donor source: Syngeneic (live related); Allogeneic (live non-related); and Zooplastic (animal). We note that bone marrow transplant procedures are coded to the root operation ``Transfusion'' as stated in the ICD-10-PCS Reference Manual (which is available on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD10/2016-ICD-10-PCS-and-GEMs.html). The root term ``Transfusion'' provides the seventh character qualifier values of Autologous and Nonautologous as options to describe donor source. For specific questions related to coding for transplants and transfusions, we refer readers to the American Hospital Association (AHA). The AHA Central OfficeTM is the national clearinghouse for medical coding advice. Coding inquiries may be directed to the following AHA Web site: http://www.CodingClinicAdvisor.com.

    Comment: One commenter pointed out that the proposed MS-DRG relative weight for MS-DRG 619 (O.R. Procedures for Obesity with MCC) is 2.8830, which is less than the MS-DRG relative weight for this MS-

    DRG for FY

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    2015 of 3.2890. The commenter stated that, while this category represents a small percentage of the total bariatric procedures performed on Medicare beneficiaries, patients with conditions described in this MS-DRG are at the greatest risk for readmission and require the greatest support and coordination of postoperative resources to ensure a safe and efficient recovery, and that providers will be unable to provide such support and resources if payment is so drastically reduced. The commenter asked CMS to reconsider the reduction, and consider an increase of 1.1 percent in the relative weight for MS-DRG 619 in keeping with Hospital IQR Program and meaningful electronic health record (EHR) user incentives. The commenter asked that, for hospitals not participating in the Hospital IQR Program or the EHR Incentive Program, CMS keep the relative weight for MS-DRG 619 neutral.

    Response: We note that, while the proposed FY 2016 relative weight for MS-DRG 619 was 2.8830, the final FY 2016 relative weight for MS-DRG 619 is 2.9418 (as reflected in Table 5 associated with this final rule and available on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2016-IPPS-Final-Rule-Home-Page.html). While we are sympathetic to the commenter's concerns, we note that the reduction in the relative weight from FY 2015 to FY 2016 is a function of the relative weight calculation, as described in section II.H. of the FY 2016 IPPS/LTCH PPS proposed rule and this final rule, which is comprised of hospitals' billed charges for MS-DRG 619 and the costs reported on hospitals' cost reports. The reduction in the relative weight may be attributed to the change in the number of cases and average charges for MS-DRG 619 used to develop the relative weight for FY 2015 and the final FY 2016 relative weight. Specifically, we observed that FY 2015 cases were 896, and FY 2016 cases are 1,037, while FY 2015 average charges were $90,806, and FY 2016 average charges are $84,592.

    We are finalizing the methodology for recalibration of the MS-DRG relative weights specified in this final rule for FY 2016 as proposed.

    4. Discussion and Acknowledgement of Public Comments Received on Expanding the Bundled Payments for Care Improvement (BPCI) Initiative

  208. Background

    Since 2011, CMS has been working to develop and test models of bundling Medicare payments under the authority of section 1115A of the Act. Through these models, CMS plans to evaluate whether bundled payments result in higher quality and more coordinated care at a lower cost to Medicare. CMS is currently testing the Bundled Payments for Care Improvement (BPCI) initiative. Under this initiative, organizations enter into payment arrangements that include financial and performance accountability for episodes of care.

    The BPCI initiative is comprised of four related payment models, which link payments for multiple services that Medicare beneficiaries receive during an episode of care into a bundled payment. Episodes of care under the BPCI initiative begin with either (1) an inpatient hospital stay or (2) postacute care services following a qualifying inpatient hospital stay. More information on the four models under the BPCI initiative can be found on the CMS Center for Medicare and Medicaid Innovation's Web site at: http://innovation.cms.gov/initiatives/bundled-payments/.

    In the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24414 through 24418), we presented a discussion of the models in the BPCI initiative and solicited public comments regarding policy and operational issues related to a potential expansion of the BPCI initiative in the future. Section 1115A(c) of the Act, as added by section 3021 of the Affordable Care Act, provides the Secretary with the authority to expand through rulemaking the duration and scope of a model that is being tested under section 1115A(b) of the Act, such as the BPCI initiative (including implementation on a nationwide basis), if the following findings are made, taking into account the evaluation of the model under section 1115A(b)(4) of the Act: (1) The Secretary determines that the expansion is expected to either reduce Medicare spending without reducing the quality of care or improve the quality of patient care without increasing spending; (2) the CMS Chief Actuary certifies that the expansion would reduce (or would not result in any increase in) net Medicare program spending; and (3) the Secretary determines that the expansion would not deny or limit the coverage or provision of Medicare benefits. The decision of whether or not to expand will be made by the Secretary in coordination with CMS and the Office of the Chief Actuary based on whether findings about the initiative meet the statutory criteria for expansion under section 1115A(c) of the Act. Given that further evaluation of the BPCI initiative is needed to determine its impact on both Medicare cost and quality of care, we did not propose an expansion of any models within the initiative or any policy changes associated with it in the FY 2016 IPPS/LTCH PPS proposed rule.

    Consistent with our continuing commitment to engaging stakeholders in CMS' work, we sought public comments on a variety of issues to broaden and deepen our understanding of the important issues and challenges regarding bundled payments in the current health care marketplace. Among other subject-matter areas, we sought public comments on the scope of any expansion, episode definitions, bundled payment amounts, data needs, and the use of health information technology. In response to our solicitation, we received over 75 timely and informative public comments suggesting matters to consider in a potential future expansion of the BPCI initiative, including the evaluation of the BPCI models, further testing of the BPCI initiative, target pricing methodologies, data collection and reporting, quality measures, episode definitions, payment methodologies, and precedence rules. We appreciate the commenters' views and recommendations. We will consider the public comments we received if the BPCI initiative is expanded in the future through rulemaking.

    I. Add-On Payments for New Services and Technologies for FY 2016

    1. Background

    Sections 1886(d)(5)(K) and (L) of the Act establish a process of identifying and ensuring adequate payment for new medical services and technologies (sometimes collectively referred to in this section as ``new technologies'') under the IPPS. Section 1886(d)(5)(K)(vi) of the Act specifies that a medical service or technology will be considered new if it meets criteria established by the Secretary after notice and opportunity for public comment. Section 1886(d)(5)(K)(ii)(I) of the Act specifies that a new medical service or technology may be considered for new technology add-on payment if, based on the estimated costs incurred with respect to discharges involving such service or technology, the DRG prospective payment rate otherwise applicable to such discharges under this subsection is inadequate. We note that, beginning with discharges occurring in FY 2008, CMS transitioned from CMS-DRGs to MS-DRGs.

    The regulations at 42 CFR 412.87 implement these provisions and specify three criteria for a new medical service or technology to receive the additional payment: (1) The medical service or

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    technology must be new; (2) the medical service or technology must be costly such that the DRG rate otherwise applicable to discharges involving the medical service or technology is determined to be inadequate; and (3) the service or technology must demonstrate a substantial clinical improvement over existing services or technologies. Below we highlight some of the major statutory and regulatory provisions relevant to the new technology add-on payment criteria as well as other information. For a complete discussion on the new technology add-on payment criteria, we refer readers to the FY 2012 IPPS/LTCH PPS final rule (76 FR 51572 through 51574).

    Under the first criterion, as reflected in Sec. 412.87(b)(2), a specific medical service or technology will be considered ``new'' for purposes of new medical service or technology add-on payments until such time as Medicare data are available to fully reflect the cost of the technology in the MS-DRG weights through recalibration. We note that we do not consider a service or technology to be new if it is substantially similar to one or more existing technologies. That is, even if a technology receives a new FDA approval, it may not necessarily be considered ``new'' for purposes of new technology add-on payments if it is ``substantially similar'' to a technology that was approved by FDA and has been on the market for more than 2 to 3 years. In the FY 2006 IPPS final rule (70 FR 47351) and the FY 2010 IPPS/RY 2010 LTCH PPS final rule (74 FR 43813 and 43814), we explained our policy regarding substantial similarity in detail.

    Under the second criterion, Sec. 412.87(b)(3) further provides that, to be eligible for the add-on payment for new medical services or technologies, the MS-DRG prospective payment rate otherwise applicable to the discharge involving the new medical services or technologies must be assessed for adequacy. Under the cost criterion, consistent with the formula specified in section 1886(d)(5)(K)(ii)(I) of the Act, to assess the adequacy of payment for a new technology paid under the applicable MS-DRG prospective payment rate, we evaluate whether the charges for cases involving the new technology exceed certain threshold amounts. We update the thresholds in Table 10 of each final rule that apply for the upcoming fiscal year. Table 10 that was released with the FY 2015 IPPS/LTCH PPS final rule contains the final thresholds that we used to evaluate applications for new medical service and new technology add-on payments for FY 2016. We refer readers to the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2015-IPPS-Final-Rule-Home-Page-Items/FY2015-Final-Rule-Tables.html to download and view Table 10.

    In the September 7, 2001 final rule that established the new technology add-on payment regulations (66 FR 46917), we discussed the issue of whether the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule at 45 CFR parts 160 and 164 applies to claims information that providers submit with applications for new medical service and new technology add-on payments. We refer readers to the FY 2012 IPPS/LTCH PPS final rule (76 FR 51573) for complete information on this issue.

    Under the third criterion, Sec. 412.87(b)(1) of our existing regulations provides that a new technology is an appropriate candidate for an additional payment when it represents an advance that substantially improves, relative to technologies previously available, the diagnosis or treatment of Medicare beneficiaries. For example, a new technology represents a substantial clinical improvement when it reduces mortality, decreases the number of hospitalizations or physician visits, or reduces recovery time compared to the technologies previously available. (We refer readers to the September 7, 2001 final rule for a more detailed discussion of this criterion (66 FR 46902).)

    The new medical service or technology add-on payment policy under the IPPS provides additional payments for cases with relatively high costs involving eligible new medical services or technologies while preserving some of the incentives inherent under an average-based prospective payment system. The payment mechanism is based on the cost to hospitals for the new medical service or technology. Under Sec. 412.88, if the costs of the discharge (determined by applying cost-to-

    charge ratios (CCRs) as described in Sec. 412.84(h)) exceed the full DRG payment (including payments for IME and DSH, but excluding outlier payments), Medicare will make an add-on payment equal to the lesser of: (1) 50 percent of the estimated costs of the new technology or medical service (if the estimated costs for the case including the new technology or medical service exceed Medicare's payment); or (2) 50 percent of the difference between the full DRG payment and the hospital's estimated cost for the case. Unless the discharge qualifies for an outlier payment, the additional Medicare payment is limited to the full MS-DRG payment plus 50 percent of the estimated costs of the new technology or new medical service.

    Section 503(d)(2) of Public Law 108-173 provides that there shall be no reduction or adjustment in aggregate payments under the IPPS due to add-on payments for new medical services and technologies. Therefore, in accordance with section 503(d)(2) of Public Law 108-173, add-on payments for new medical services or technologies for FY 2005 and later years have not been subjected to budget neutrality.

    In the FY 2009 IPPS final rule (73 FR 48561 through 48563), we modified our regulations at Sec. 412.87 to codify our longstanding practice of how CMS evaluates the eligibility criteria for new medical service or technology add-on payment applications. That is, we first determine whether a medical service or technology meets the newness criterion, and only if so, do we then make a determination as to whether the technology meets the cost threshold and represents a substantial clinical improvement over existing medical services or technologies. We amended Sec. 412.87(c) to specify that all applicants for new technology add-on payments must have FDA approval or clearance for their new medical service or technology by July 1 of each year prior to the beginning of the fiscal year that the application is being considered.

    The Council on Technology and Innovation (CTI) at CMS oversees the agency's cross-cutting priority on coordinating coverage, coding and payment processes for Medicare with respect to new technologies and procedures, including new drug therapies, as well as promoting the exchange of information on new technologies and medical services between CMS and other entities. The CTI, composed of senior CMS staff and clinicians, was established under section 942(a) of Public Law 108-

    173. The Council is co-chaired by the Director of the Center for Clinical Standards and Quality (CCSQ) and the Director of the Center for Medicare (CM), who is also designated as the CTI's Executive Coordinator.

    The specific processes for coverage, coding, and payment are implemented by CM, CCSQ, and the local claims-payment contractors (in the case of local coverage and payment decisions). The CTI supplements, rather than replaces, these processes by working to assure that all of these activities reflect the agency-wide priority to promote high-

    quality, innovative care. At the same time, the CTI also works to streamline, accelerate, and improve coordination of these processes to ensure that they remain up to date as new issues arise.

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    To achieve its goals, the CTI works to streamline and create a more transparent coding and payment process, improve the quality of medical decisions, and speed patient access to effective new treatments. It is also dedicated to supporting better decisions by patients and doctors in using Medicare-covered services through the promotion of better evidence development, which is critical for improving the quality of care for Medicare beneficiaries.

    To improve the understanding of CMS' processes for coverage, coding, and payment and how to access them, the CTI has developed an ``Innovator's Guide'' to these processes. The intent is to consolidate this information, much of which is already available in a variety of CMS documents and in various places on the CMS Web site, in a user-

    friendly format. This guide was published in 2010 and is available on the CMS Web site at: http://www.cms.gov/CouncilonTechInnov/Downloads/InnovatorsGuide5_10_10.pdf.

    As we indicated in the FY 2009 IPPS final rule (73 FR 48554), we invite any product developers or manufacturers of new medical services or technologies to contact the agency early in the process of product development if they have questions or concerns about the evidence that would be needed later in the development process for the agency's coverage decisions for Medicare.

    The CTI aims to provide useful information on its activities and initiatives to stakeholders, including Medicare beneficiaries, advocates, medical product manufacturers, providers, and health policy experts. Stakeholders with further questions about Medicare's coverage, coding, and payment processes, or who want further guidance about how they can navigate these processes, can contact the CTI at CTI@cms.hhs.gov.

    We note that applicants for add-on payments for new medical services or technologies for FY 2017 must submit a formal request, including a full description of the clinical applications of the medical service or technology and the results of any clinical evaluations demonstrating that the new medical service or technology represents a substantial clinical improvement, along with a significant sample of data to demonstrate that the medical service or technology meets the high-cost threshold. Complete application information, along with final deadlines for submitting a full application, will be posted as it becomes available on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html. To allow interested parties to identify the new medical services or technologies under review before the publication of the proposed rule for FY 2017, the CMS Web site also will post the tracking forms completed by each applicant.

    2. Public Input Before Publication of a Notice of Proposed Rulemaking on Add-On Payments

    Section 1886(d)(5)(K)(viii) of the Act, as amended by section 503(b)(2) of Public Law 108-173, provides for a mechanism for public input before publication of a notice of proposed rulemaking regarding whether a medical service or technology represents a substantial clinical improvement or advancement. The process for evaluating new medical service and technology applications requires the Secretary to--

    Provide, before publication of a proposed rule, for public input regarding whether a new service or technology represents an advance in medical technology that substantially improves the diagnosis or treatment of Medicare beneficiaries;

    Make public and periodically update a list of the services and technologies for which applications for add-on payments are pending;

    Accept comments, recommendations, and data from the public regarding whether a service or technology represents a substantial clinical improvement; and

    Provide, before publication of a proposed rule, for a meeting at which organizations representing hospitals, physicians, manufacturers, and any other interested party may present comments, recommendations, and data regarding whether a new medical service or technology represents a substantial clinical improvement to the clinical staff of CMS.

    In order to provide an opportunity for public input regarding add-

    on payments for new medical services and technologies for FY 2016 prior to publication of the FY 2016 IPPS/LTCH PPS proposed rule, we published a notice in the Federal Register on November 21, 2014 (79 FR 69490), and held a town hall meeting at the CMS Headquarters Office in Baltimore, MD, on February 3, 2015. In the announcement notice for the meeting, we stated that the opinions and alternatives provided during the meeting would assist us in our evaluations of applications by allowing public discussion of the substantial clinical improvement criterion for each of the FY 2016 new medical service and technology add-on payment applications before the publication of the FY 2016 IPPS/

    LTCH PPS proposed rule.

    Approximately 95 individuals registered to attend the town hall meeting in person, while additional individuals listened over an open telephone line. We also live-streamed the town hall meeting and posted the town hall on the CMS YouTube Web page at: https://www.youtube.com/watch?v=dn-R5KGQu-M. We considered each applicant's presentation made at the town hall meeting, as well as written comments submitted on the applications that were received by the due date of January 19, 2015, in our evaluation of the new technology add-on payment applications for FY 2016 in the proposed rule.

    In response to the published notice and the New Technology Town Hall meeting, we received written comments regarding the applications for FY 2016 new technology add-on payments. We summarized these comments in the preamble of the proposed rule or, if applicable, indicated that there were no comments received, at the end of each discussion of the individual applications in the proposed rule. We are not reprinting those summations in this final rule and refer readers to the FY 2016 IPPS/LTCH PPS proposed rule for this discussion.

    We also received public comments in response to the proposed rule relating to topics such as marginal cost factors for new technology add-on payments, mapping new technologies to the appropriate MS-DRG, additional criteria for substantial clinical improvement, and changing the newness criterion. Because we did not request public comments nor propose to make any changes to any of the issues above, we are not summarizing these public comments nor responding to them in this final rule.

    Comment: One commenter stated that it is not appropriate for CMS to continue to add requirements or to impose standards that exceed realistic requirements for clinical trials. The commenter cited the WATCHMANsupreg System as an example where CMS suggested that substantial clinical improvement should be based on a superiority trial rather than the noninferiority trial that was used.

    Response: We received a similar public comment last year and responded to it in the FY 2015 IPPS/LTCH PPS final rule. We refer the readers to the FY 2015 IPPS/LTCH PPS final rule (79 FR 49925 through 49926) for a complete response to this issue.

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    3. Implementation of ICD-10-PCS Section ``X'' Codes for Certain New Medical Services and Technologies for FY 2016

    As discussed in section II.G.1.a. of the preamble of this final rule, HIPAA covered entities are required, as of October 1, 2015, to use the ICD-10 coding system (ICD-10-PCS codes for procedures and ICD-

    10-CM codes for diagnosis), instead of the ICD-9-CM coding system, to report diagnoses and procedures for Medicare hospital inpatient services provided to Medicare beneficiaries as classified under the MS-

    DRG system and paid for under the IPPS. HIPAA covered entities must continue to use ICD-9-CM codes and coding guidelines through September 30, 2015. We refer readers to section II.G.1.a. of the preamble of this final rule for a complete discussion of the adoption of the ICD-10 coding system.

    As part of the transition to the ICD-10-CM/PCS coding system, at the September 23-24, 2014 ICD-10 Coordination and Maintenance Committee meeting, CMS received a request to create a new section within the ICD-

    10-PCS to capture new medical services and technologies that might not appropriately align with the current structure of the ICD-10-PCS codes. Examples of these types of new medical services and technologies included drugs, biologicals, and newer medical devices being tested in clinical trials that are not currently captured within the ICD-9-CM or the ICD-10-PCS. The requestor indicated that there may be a need to identify and report these technologies and inpatient services for purposes of approving new technology add-on payment applications and initiating subsequent new technology add-on payments based on approval or tracking and analyzing the use of these new technologies and services. Although several commenters have opposed including these types of technologies and services within the current structure of the ICD-10-PCS codes during past ICD-10 Coordination and Maintenance Committee meetings, as well as in public comments, CMS has evaluated these suggestions and considered them to be valid. As a result, CMS has created a new component within the ICD-10-PCS codes, labeled Section ``X'' codes, to identify and describe these new technologies and services. The new Section ``X'' codes identify new medical services and technologies that are not usually captured by coders, or that do not usually have the desired specificity within the current ICD-10-PCS structure required to capture the use of these new services and technologies. As mentioned earlier, examples of these types of services and technologies include specific drugs, biologicals, and newer medical devices being tested in clinical trials. The new Section ``X'' codes within the ICD-10-PCS structure will be implemented on October 1, 2015, and will be used to identify new technologies and medical services approved under the new technology add-on payment policy for payment purposes beginning October 1, 2015. The Section ``X'' codes also will be used to identify procedures or services that are not commonly captured within the definitions and descriptions included in most coding systems or procedures or services that require definitions and descriptions that contain greater detail or specificity, which may be needed for a variety of health care data needs. An overview of Section ``X'' codes was provided at the March 18-19, 2015 ICD-10 Coordination and Maintenance Committee meeting. We also have posted an article on the CMS Web site that explains the creation and use of ICD-10-PCS Section ``X'' codes. This article can be found on the CMS 2016 ICD-10-

    PCS and GEMs Web site at http://www.cms.gov/Medicare/Coding/ICD10/2016-ICD-10-PCS-and-GEMs.html. Further information regarding the new Section ``X'' codes and their use within the ICD-10-PCS can be found on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/ICD-9-CM-C-and-M-Meeting-Materials.html through the ``CMS Coordination and Maintenance Committee Meeting'' link.

    In addition, on June 18, 2015, CMS held a National ICD-10 Teleconference (Preparing for Implementation and New ICD-10-PCS Section ``X'' MLN Connects National Provider Call) to explain the Section ``X'' codes under the ICD-10. The agenda, slides, and audio from this teleconference are posted on the CMS Web site at: http://www.cms.gov/Outreach-and-Education/Outreach/NPC/National-Provider-Calls-and-Events-Items/2015-06-18-ICD10.html?DLPage=1&DLSort=0&DLSortDir=descending.

    As stated earlier, the ICD-10-PCS includes a new section containing the new Section ``X'' codes, which will be used beginning with discharges occurring on or after October 1, 2015. Decisions regarding changes to ICD-10-PCS Section ``X'' codes will be handled in the same manner as the decisions for all of the other ICD-10-PCS code changes. That is, proposals to create, delete, or revise Section ``X'' codes under the ICD-10-PCS structure will be referred to the ICD-10 Coordination and Maintenance Committee. In addition, several of the new medical services and technologies that have been, or may be, approved for new technology add-on payments may now, and in the future, be assigned a Section ``X'' code within the structure of the ICD-10-PCS. The FY 2016 ICD-10-PCS, which includes the new Section ``X'' codes, was posted in June 2015 via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD10/2016-ICD-10-PCS-and-GEMs.html. We also posted the FY 2016 ICD-10-PCS Guidelines on this CMS Web site that also includes guidelines for ICD-10-PCS ``X'' codes. We encourage providers to view the material provided on ICD-10-PCS Section ``X'' codes.

    Comment: Several commenters supported the creation of the new ICD-

    10-PCS Section ``X'' codes as a means to more specifically identify new technologies or more precise information about certain services. The commenters recognized the challenges of maintaining a partial code freeze while at the same time finding a way to capture new procedures. One commenter who supported the creation of the new Section ``X'' codes to identify new medical services and technologies stated that it was important to have a more robust coding system that will allow for recognition of more technologies, procedures, and variations in patients' conditions.

    Another commenter recognized the need to conserve code values within the regular ICD-10-PCS sections, as well as the exponential effect that adding a new value has on the large number of codes, and noted the importance of using Section ``X'' codes specifically for certain types of new technologies. The commenter stated that Section ``X'' codes are especially important to identify drugs and intraoperative supplies related to MS-DRG new technology add-on payments.

    Response: We appreciate the commenters' support.

    Comment: Several commenters expressed concern that payers may mistakenly consider ICD-10-PCS Section ``X'' codes as interchangeable with CPT Category III codes. The commenters stated that, although CPT Category III codes also represent emerging technologies, the technologies lack substantive support in professional literature, and the codes used for these technologies often describe noncovered procedures that are experimental or investigational. In contrast, the commenter recognized that ICD-10-PCS Section ``X'' codes describe new technologies or services that frequently are FDA approved. However, the

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    commenters asked that CMS clarify that ICD-10-PCS Section ``X'' codes will not be used to specifically identify experimental or unproven procedures.

    Response: Section ``X'' codes were created to more specifically identify new technologies, procedures that have historically not been captured through ICD-9-CM codes, or to more precisely describe information on a specific procedure or technology than is found with the other sections of ICD-10-PCS. Section ``X'' codes were not created, nor intended to be used, to identify experimental or investigational procedures.

    Comment: Several commenters expressed concerns about the decision to create new codes during the partial code freeze, in particular the creation of the ICD-10-PCS Section ``X'' during the partial code freeze. The commenters believed that it would be more appropriate to delay the implementation of this section of the ICD-10-PCS and the use of Section ``X'' codes until after the ICD-10 coding system is implemented and the partial code freeze ends. The commenters also requested clarifications on how the new Section ``X'' codes would be used.

    Response: We acknowledge that it has been a challenge for CMS to implement the ICD-10-PCS/CM coding system, particularly in light of the partial code freeze and several delays of the implementation of ICD-10. However, the partial code freeze has allowed sufficient time and the ability to capture new technologies or new medical services under the new coding system. Many participants at the ICD-10 Coordination and Maintenance Committee have voiced opposition to the creation of any new codes during the partial code freeze. Other participants have actively encouraged the creation of more code updates beyond those that capture new technologies or new medical services. We have given consideration to all of the public comments presented at the ICD-10 Coordination and Maintenance Committee meetings and have attempted to make updates to the ICD-10-CM/PCS in a manner that is most appropriate and results in less burden on the majority of users. Any updates to ICD-10-CM/PCS, including updates to the Section ``X'' codes, will be presented at future ICD-10 Coordination and Maintenance Committee meetings for public comments. For those individuals who are interested in participating in future ICD-10 Coordination and Maintenance Committee meetings, information on the Committee can be found on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/meetings.html. We encourage public participation at these meetings either in person, by conference lines, or by the livestream provided by CMS. As discussed earlier, CMS has posted the FY 2016 ICD-10-PCS guidelines, which include guidelines on the use of Section ``X'' codes and an article explaining why ICD-10-PCS Section ``X'' codes were created and how to use them on the CMS Web site. We believe that this detailed information will assist coders in using the new Section ``X'' codes.

    4. FY 2016 Status of Technologies Approved for FY 2015 Add-On Payments

  209. Glucarpidase (Voraxazesupreg)

    BTG International, Inc. submitted an application for new technology add-on payments for Glucarpidase (Voraxazesupreg) for FY 2013. Glucarpidase is used in the treatment of patients who have been diagnosed with toxic methotrexate (MTX) concentrations as of result of renal impairment. The administration of Glucarpidase causes a rapid and sustained reduction of toxic MTX concentrations.

    Voraxazesupreg was approved by the FDA on January 17, 2012. Beginning in 1993, certain patients could obtain expanded access for treatment use to Voraxazesupreg as an investigational drug. Since 2007, the applicant has been authorized to recover the costs of making Voraxazesupreg available through its expanded access program. We describe expanded access for treatment use of investigational drugs and authorization to recover certain costs of investigational drugs in the FY 2013 IPPS/LTCH PPS final rule (77 FR 53346 through 53350). Voraxazesupreg was available on the market in the United States as a commercial product to the larger population as of April 30, 2012. In the FY 2013 IPPS/LTCH PPS proposed rule (77 FR 27936 through 27939), we expressed concerns about whether Voraxazesupreg could be considered new for FY 2013. After consideration of all of the public comments received, in the FY 2013 IPPS/LTCH PPS final rule, we stated that we considered Voraxazesupreg to be ``new'' as of April 30, 2012, which is the date of U.S. market availability.

    After evaluation of the newness, costs, and substantial clinical improvement criteria for new technology payments for Voraxazesupreg and consideration of the public comments we received in response to the FY 2013 IPPS/LTCH PPS proposed rule, we approved Voraxazesupreg for new technology add-on payments for FY 2013. Cases of Voraxazesupreg are identified with ICD-9-CM procedure code 00.95 (Injection or infusion of glucarpidase). As stated in the FY 2015 IPPS/LTCH PPS final rule correction notice (79 FR 59679), the cost of Voraxazesupreg is $23,625 per vial. The applicant stated that an average of four vials is used per Medicare beneficiary. Therefore, the average cost per case for Voraxazesupreg is $94,500 ($23,625 x 4). Under Sec. 412.88(a)(2), we limit new technology add-on payments to the lesser of 50 percent of the average cost of the technology or 50 percent of the costs in excess of the MS-DRG payment for the case. As a result, the maximum new technology add-on payment for Voraxazesupreg is $47,250 per case.

    As stated above, the new technology add-on payment regulations provide that a medical service or technology may be considered new within 2 or 3 years after the point at which data begin to become available reflecting the ICD-9-CM code assigned to the new service or technology (Sec. 412.87(b)(2)). Our practice has been to begin and end new technology add-on payments on the basis of a fiscal year, and we have generally followed a guideline that uses a 6-month window before and after the start of the fiscal year to determine whether to extend the new technology add-on payment for an additional fiscal year. In general, we extend add-on payments for an additional year only if the 3-year anniversary date of the product's entry on the market occurs in the latter half of the fiscal year (70 FR 47362).

    With regard to the newness criterion for Voraxazesupreg, we considered the beginning of the newness period to commence when Voraxazesupreg was first made available on the U.S. market on April 30, 2012. Because the 3-year anniversary date for Voraxazesupreg occurred in the latter half of FY 2015 (April 30, 2015), in the FY 2015 IPPS/LTCH PPS final rule, we continued new technology add-on payments for this technology for FY 2015 (79 FR 49918). However, for FY 2016, the 3-year anniversary date of the product's entry on the U.S. market (April 30, 2015) occurred prior to the beginning of FY 2016. Therefore, we proposed to discontinue new technology add-on payments for Voraxazesupreg for FY 2016. We invited public comments on this proposal.

    Comment: One commenter supported CMS' proposal to discontinue new technology add-on payments for Voraxazesupreg for FY 2016.

    Response: We appreciate the commenter's support.

    After consideration of the public comments we received, we are discontinuing new technology add-on payments for Voraxazesupreg for FY 2016. The 3-year anniversary date of the

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    product's entry onto the U.S. market occurred prior to the beginning of FY 2016 and, therefore, the technology will no longer be eligible for new technology add-on payments because the technology will no longer meet the ``newness'' criterion.

  210. Zenithsupreg Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft

    Cooksupreg Medical submitted an application for new technology add-on payments for the Zenithsupreg Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft (Zenithsupreg F. Graft) for FY 2013. The applicant stated that the current treatment for patients who have had an AAA is an endovascular graft. The applicant explained that the Zenithsupreg F. Graft is an implantable device designed to treat patients who have an AAA and who are anatomically unsuitable for treatment with currently approved AAA endovascular grafts because of the length of the infrarenal aortic neck. The applicant noted that, currently, an AAA is treated through an open surgical repair or medical management for those patients not eligible for currently approved AAA endovascular grafts.

    With respect to newness, the applicant stated that FDA approval for the use of the Zenithsupreg F. Graft was granted on April 4, 2012. In the FY 2013 IPPS/LTCH PPS final rule (77 FR 53360 through 53365), we stated that because the Zenithsupreg F. Graft was approved by the FDA on April 4, 2012, we believed that the Zenithsupreg F. Graft met the newness criterion as of that date.

    After evaluation of the newness, costs, and substantial clinical improvement criteria for new technology add-on payments for the Zenithsupreg F. Graft and consideration of the public comments we received in response to the FY 2013 IPPS/LTCH PPS proposed rule, we approved the Zenithsupreg F. Graft for new technology add-on payments for FY 2013. Cases involving the Zenithsupreg F. Graft that are eligible for new technology add-on payments currently are identified by ICD-9-CM procedure code 39.78 (Endovascular implantation of branching or fenestrated graft(s) in aorta). In the application, the applicant provided a breakdown of the costs of the Zenithsupreg F. Graft. The total cost of the Zenithsupreg F. Graft utilizing bare metal (renal) alignment stents was $17,264. Of the $17,264 in costs for the Zenithsupreg F. Graft, $921 is for components that are used in a standard Zenith AAA Endovascular Graft procedure. Because the costs for these components are already reflected within the MS-DRGs (and are no longer ``new''), in the FY 2013 IPPS/LTCH PPS final rule, we stated that we did not believe it is appropriate to include these costs in our calculation of the maximum cost to determine the maximum add-on payment for the Zenithsupreg F. Graft. Therefore, the total maximum cost for the Zenithsupreg F. Graft is $16,343 ($17,264-$921). Under Sec. 412.88(a)(2), we limit new technology add-on payments to the lesser of 50 percent of the average cost of the device or 50 percent of the costs in excess of the MS-DRG payment for the case. As a result, the maximum add-on payment for a case involving the Zenithsupreg F. Graft is $8,171.50.

    With regard to the newness criterion for the Zenithsupreg F. Graft, we considered the beginning of the newness period to commence when the Zenithsupreg F. Graft was approved by the FDA on April 4, 2012. Because the 3-year anniversary date of the entry of the Zenithsupreg F. Graft on the U.S. market occurred in the second half of FY 2015 (April 4, 2015), in the FY 2015 IPPS/LTCH PPS final rule, we continued new technology add-on payments for this technology for FY 2015 (79 FR 49922). However, for FY 2016, the 3-year anniversary date of the product's entry on the U.S. market (April 4, 2015) occurred prior to the beginning of FY 2016. Therefore, we proposed to discontinue new technology add-on payments for the Zenithsupreg F. Graft for FY 2016. We invited public comments on this proposal.

    We did not receive any public comments on our proposal. Therefore, as we proposed, we are discontinuing new technology add-on payments for the Zenithsupreg F. Graft technology for FY 2016. The 3-year anniversary of the product's entry onto the U.S. market occurred prior to the beginning of FY 2016 and, therefore, the technology is not eligible for new technology add-on payments for FY 2016 because the technology will no longer meet ``newness'' criterion.

  211. KcentraTM

    CSL Behring submitted an application for new technology add-on payments for KcentraTM for FY 2014. KcentraTM is a replacement therapy for fresh frozen plasma (FFP) for patients with an acquired coagulation factor deficiency due to warfarin and who are experiencing a severe bleed. KcentraTM contains the Vitamin K dependent coagulation factors II, VII, IX and X, together known as the prothrombin complex, and antithrombotic proteins C and S. Factor IX is the lead factor for the potency of the preparation. The product is a heat-treated, non-activated, virus filtered and lyophilized plasma protein concentrate made from pooled human plasma. KcentraTM is available as a lyophilized powder that needs to be reconstituted with sterile water prior to administration via intravenous infusion. The product is dosed based on Factor IX units. Concurrent Vitamin K treatment is recommended to maintain blood clotting factor levels once the effects of KcentraTM have diminished.

    KcentraTM was approved by the FDA on April 29, 2013. In the FY 2014 IPPS/LTCH PPS final rule, we finalized new ICD-9-CM procedure code 00.96 (Infusion of 4-Factor Prothrombrin Complex Concentrate) which uniquely identifies KcentraTM.

    In the FY 2014 IPPS/LTCH PPS proposed rule (78 FR 27538), we noted that we were concerned that KcentraTM may be substantially similar to FFP and/or Vitamin K therapy. In the FY 2014 IPPS/LTCH PPS final rule, in response to comments submitted by the manufacturer, we stated that we agree that KcentraTM may be used in a patient population that is experiencing an acquired coagulation factor deficiency due to Warfarin and who are experiencing a severe bleed currently but are ineligible for FFP, particularly for use by IgA deficient patients and other patient populations that have no other treatment option to resolve severe bleeding in the context of an acquired Vitamin K deficiency. In addition, FFP is limited because it requires special storage conditions while KcentraTM is stable for up to 36 months at room temperature thus allowing hospitals that otherwise would not have access to FFP (for example, small rural hospitals as discussed by the applicant in its comments) to keep a supply of KcentraTM and treat patients who would possibly have no access to FFP. We noted that FFP is considered perishable and can be scarce by nature (due to production and other market limitations) thus making some hospitals unable to store FFP, which limits access to certain patient populations in certain locations. Therefore, we stated that we believe that KcentraTM provides a therapeutic option for a new patient population and is not substantially similar to FFP. Also, we gave credence to the information presented by the manufacturer that KcentraTM provides a simple and rapid repletion relative to FFP and reduces the risk of a transfusion reaction relative to FFP because it does not contain ABO antibodies and does not require ABO typing. As a result, we concluded that KcentraTM is not substantially similar to FFP, and that it meets the newness criterion.

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    After evaluation of the newness, cost, and substantial clinical improvement criteria for new technology add-on payments for KcentraTM and consideration of the public comments we received in response to the FY 2014 IPPS/LTCH PPS proposed rule, we approved KcentraTM for new technology add-on payments for FY 2014 (78 FR 50575 through 50580). Cases involving KcentraTM that are eligible for new technology add-on payments currently are identified by ICD-9-CM procedure code 00.96. In the application, the applicant estimated that the average Medicare beneficiary would require an average dosage of 2500 International Units (IU). Vials contain 500 IU at a cost of $635 per vial. Therefore, cases of KcentraTM would incur an average cost per case of $3,175 ($635 x 5). Under Sec. 412.88(a)(2), we limit new technology add-on payments to the lesser of 50 percent of the average cost of the technology or 50 percent of the costs in excess of the MS-DRG payment for the case. As a result, the maximum add-on payment for a case of KcentraTM was $1,587.50 for FY 2014.

    In the FY 2014 IPPS/LTCH PPS final rule (78 FR 50579), we stated that new technology add-on payments for KcentraTM would not be available with respect to discharges for which the hospital received an add-on payment for a blood clotting factor administered to a Medicare beneficiary with hemophilia who is a hospital inpatient. Under section 1886(d)(1)(A)(iii) of the Act, the national adjusted DRG prospective payment rate is the amount of the payment with respect to the operating costs of inpatient hospital services (as defined in subsection (a)(4)) for discharges on or after April 1, 1988. Section 1886(a)(4) of the Act excludes from the term ``operating costs of inpatient hospital services'' the costs with respect to administering blood clotting factors to individuals with hemophilia. The costs of administering a blood clotting factor to a Medicare beneficiary who has hemophilia and is a hospital inpatient are paid separately from the IPPS. (For information on how the blood clotting factor add-on payment is made, we refer readers to Section 20.7.3, Chapter 3, of the Medicare Claims Processing Manual, which can be downloaded from the CMS Web site at: http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c03.pdf.) In addition, we stated that if KcentraTM is approved by the FDA as a blood clotting factor, we believed that it may be eligible for blood clotting factor add-on payments when administered to Medicare beneficiaries with hemophilia. We make an add-on payment for KcentraTM for such discharges in accordance with our policy for payment of a blood clotting factor, and the costs would be excluded from the operating costs of inpatient hospital services as set forth in section 1886(a)(4) of the Act.

    Section 1886(d)(5)(K)(i) of the Act requires the Secretary to establish a mechanism to recognize the costs of new medical services and technologies under the payment system established under this subsection beginning with discharges on or after October 1, 2001. We believe that it is reasonable to interpret this requirement to mean that the payment mechanism established by the Secretary recognizes only costs for those items that would otherwise be paid based on the prospective payment system (that is, ``the payment system established under this subsection''). As noted above, under section 1886(d)(1)(A)(iii) of the Act, the national adjusted DRG prospective payment rate is the amount of payment for the operating costs of inpatient hospital services, as defined in section 1886(a)(4) of the Act, for discharges on or after April 1, 1988. We understand this to mean that a new medical service or technology must be an operating cost of inpatient hospital services paid based on the prospective payment system, and not excluded from such costs, in order to be eligible for the new technology add-on payment. We pointed out that new technology add-on payments are based on the operating costs per case relative to the prospective payment rate as described in Sec. 412.88. Therefore, we believe that new technology add-on payments are appropriate only when the new technology is an operating cost of inpatient hospital services and are not appropriate when the new technology is excluded from such costs.

    In the FY 2014 IPPS/LTCH PPS final rule (78 FR 50579), we stated that we believe that hospitals may only receive new technology add-on payments for discharges where KcentraTM is an operating cost of inpatient hospital services. In other words, a hospital would not be eligible to receive the new technology add-on payment when it is administering KcentraTM in treating a Medicare beneficiary who has hemophilia. In those instances, KcentraTM is specifically excluded from the operating costs of inpatient hospital services in accordance with section 1886(a)(4) of the Act and paid separately from the IPPS. However, when a hospital administers KcentraTM to a Medicare beneficiary who does not have hemophilia, the hospital would be eligible for a new technology add-on payment because KcentraTM would not be excluded from the operating costs of inpatient hospital services. Therefore, discharges where the hospital receives a blood clotting factor add-on payment are not eligible for a new technology add-on payment for the blood clotting factor. We refer readers to Section 20.7.3, Chapter 3, of the Medicare Claims Processing Manual for a complete discussion on when a blood clotting factor add-on payment is made. The manual can be downloaded from the CMS Web site at: http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c03.pdf.

    With regard to the newness criterion for KcentraTM, we considered the beginning of the newness period to commence when KcentraTM was approved by the FDA on April 29, 2013. Because the 3-year anniversary date of the entry of KcentraTM on the U.S. market will occur in the second half of FY 2016 (April 29, 2016), we proposed to continue new technology add-on payments for this technology for FY 2016.

    Because we are adopting the ICD-10 coding system effective October 1, 2015, for FY 2016, we proposed to identify and make new technology add-on payments for cases involving KcentraTM with ICD 10 PCS procedure code 30283B1 (Transfusion of nonautologous 4-factor prothrombin complex concentrate into vein, percutaneous approach). We stated that the maximum new technology add-on payment for a case involving the KcentraTM technology would remain at $1,587.50 for FY 2016.

    We invited public comments on these proposals.

    Comment: One commenter supported CMS' proposal to continue new technology add-on payments for KcentraTM for FY 2016.

    Response: We appreciate the commenter's support.

    We did not receive any public comments on the coding and payment for KcentraTM for FY 2016.

    After consideration of the public comments we received, we are finalizing our proposal to continue new technology add-on payments for the KcentraTM technology for FY 2016. Because we are adopting the ICD-10 coding system effective October 1, 2015, for FY 2016, as we proposed, we will identify and make new technology add-on payments for cases involving KcentraTM with the presence of ICD-10-PCS procedure code 30283B1 (Transfusion of nonautologous 4-

    factor prothrombin complex concentrate into vein, percutaneous approach). New technology add-on payments for

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    KcentraTM will not be available with respect to discharges for which the hospital received an add-on payment for a blood clotting factor administered to a Medicare beneficiary with hemophilia who is a hospital inpatient. For information on how the blood clotting factor add-on payment is made (including a list of ICD-10 diagnosis codes that would negate the eligibility of a case for new technology add-on payments, if reported in combination with the ICD-10 procedure code used to identify cases involving the KcentraTM technology), we refer readers to Section 20.7.3, Chapter 3, of the Medicare Claims Processing Manual, which is available via the Internet on the CMS Web site at: http://cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c03.pdf. The maximum new technology add-on payment for a case involving the KcentraTM technology will remain at $1,587.50 for FY 2016.

  212. Argussupreg II Retinal Prosthesis System

    Second Sight Medical Products, Inc. submitted an application for new technology add-on payments for the Argussupreg II Retinal Prosthesis System (Argussupreg II System) for FY 2014. The Argussupreg II System is an active implantable medical device that is intended to provide electrical stimulation of the retina to induce visual perception in patients who are profoundly blind due to retinitis pigmentosa (RP). These patients have bare or no light perception in both eyes. The system employs electrical signals to bypass dead photo-

    receptor cells and stimulate the overlying neurons according to a real-

    time video signal that is wirelessly transmitted from an externally worn video camera. The Argussupreg II implant is intended to be implanted in a single eye, typically the worse-seeing eye. Currently, bilateral implants are not intended for this technology. According to the applicant, the surgical implant procedure takes approximately 4 hours and is performed under general anesthesia.

    The Argussupreg II System consists of three primary components: (1) An implant which is an epiretinal prosthesis that is fully implanted on and in the eye (that is, there are no percutaneous leads); (2) external components worn by the user; and (3) a ``fitting'' system for the clinician that is periodically used to perform diagnostic tests with the system and to custom-program the external unit for use by the patient. We describe these components more fully below.

    Implant: The retinal prosthesis implant is responsible for receiving information from the external components of the system and electrically stimulating the retina to induce visual perception. The retinal implant consists of: (a) A receiving coil for receiving information and power from the external components of the Argussupreg II System; (b) electronics to drive stimulation of the electrodes; and (c) an electrode array. The receiving coil and electronics are secured to the outside of the eye using a standard scleral band and sutures, while the electrode array is secured to the surface of the retina inside the eye by a retinal tack. A cable, which passes through the eye wall, connects the electronics to the electrode array. A pericardial graft is placed over the extra-ocular portion on the outside of the eye.

    External Components: The implant receives power and data commands wirelessly from an external unit of components, which include the Argus II Glasses and Video Processing Unit (VPU). A small lightweight video camera and transmitting coil are mounted on the glasses. The telemetry coils and radio-frequency system are mounted on the temple arm of the glasses for transmitting data from the VPU to the implant. The glasses are connected to the VPU by a cable. This VPU is worn by the patient, typically on a belt or a strap, and is used to process the images from the video camera and convert the images into electrical stimulation commands, which are transmitted wirelessly to the implant.

    ``Fitting System'': To be able to use the Argussupreg II System, a patient's VPU needs to be custom-programmed. This process, which the applicant called ``fitting'', occurs in the hospital/clinic shortly after the implant surgery and then periodically thereafter as needed. The clinician/physician also uses the ``Fitting System'' to run diagnostic tests (for example, to obtain electrode and impedance waveform measurements or to check the radio-frequency link between the implant and external unit). This ``Fitting System'' can also be connected to a ``Psychophysical Test System'' to evaluate patients' performance with the Argussupreg II System on an ongoing basis.

    These three components work together to stimulate the retina and allow a patient to perceive phosphenes (spots of light), which they then need to learn to interpret. While using the Argussupreg II System, the video camera on the patient-worn glasses captures a video image. The video camera signal is sent to the VPU, which processes the video camera image and transforms it into electrical stimulation patterns. The electrical stimulation data are then sent to a transmitter coil mounted on the glasses. The transmitter coil sends both data and power via radio-frequency (RF) telemetry to the implanted retinal prosthesis. The implant receives the RF commands and delivers stimulation to the retina via an array of electrodes that is secured to the retina with a retinal tack.

    In patients with RP, the photoreceptor cells in the retina, which normally transduce incoming light into an electro-chemical signal, have lost most of their function. The stimulation pulses delivered to the retina via the electrode array of the Argussupreg II System are intended to mimic the function of these degenerated photoreceptors cells. These pulses induce cellular responses in the remaining, viable retinal nerve cells that travel through the optic nerve to the visual cortex where they are perceived as phosphenes (spots of light). Patients learn to interpret the visual patterns produced by these phosphenes.

    With respect to the newness criterion, according to the applicant, the FDA designated the Argussupreg II System a Humanitarian Use Device in May 2009 (HUD designation #09-0216). The applicant submitted a Humanitarian Device Exemption (HDE) application (#H110002) to the FDA in May 2011 to obtain market approval for the Argussupreg II System. The HDE was referred to the Ophthalmic Devices Panel of the FDA's Medical Devices Advisory Committee for review and recommendation. At the Panel's meeting held on September 28, 2012, the Panel voted 19 to 0 that the probable benefits of the Argussupreg II System outweigh the risks of the system for the proposed indication for use. The applicant received the HDE approval from the FDA on February 14, 2013. However, in the FY 2015 IPPS/LTCH PPS final rule (79 FR 49924 through 49925), we discussed comments we had received informing CMS that the Argussupreg II System was not available on the U.S. market until December 20, 2013. The applicant explained that, as part of the lengthy approval process, it was required to submit a request to the Federal Communications Commission (FCC) for a waiver of section 15.209(a) of the FCC rules that would allow the applicant to apply for FCC authorization to utilize this specific RF band. The FCC approved the applicant's waiver request on November 30, 2011. After receiving the FCC waiver of the section 15.209(a) rules, the applicant requested and obtained a required Grant of Equipment Authorization to utilize the specific RF band, which the FCC issued on December 20, 2013. Therefore, the applicant stated that the date the Argussupreg II System first became available for commercial sale in the United States

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    was December 20, 2013. We agreed with the applicant that, due to the delay, the date of newness for the Argussupreg II System was December 20, 2013, instead of February 14, 2013.

    Currently there are no other approved treatments for patients diagnosed with severe to profound RP. The Argussupreg II System has an IDE number of G050001 and is a Class III device. In the FY 2014 IPPS/LTCH PPS final rule (78 FR 50580 through 50583), we finalized new ICD-9-CM procedure code 14.81 (Implantation of epiretinal visual prosthesis), which uniquely identifies the Argussupreg II System. The other two codes finalized by CMS are for removal, revision, or replacement of the device.

    After evaluation of the new technology add-on payment application and consideration of public comments received, we concluded that the Argussupreg II System met all of the new technology add-on payment policy criteria. Therefore, we approved the Argussupreg II System for new technology add-on payments in FY 2014 (78 FR 50580 through 50583). Cases involving the Argussupreg II System that are eligible for new technology add-on payments currently are identified by ICD-9-CM procedure code 14.81. We note that section 1886(d)(5)(K)(i) of the Act requires that the Secretary establish a mechanism to recognize the costs of new medical services or technologies under the payment system established under that subsection, which establishes the system for paying for the operating costs of inpatient hospital services. The system of payment for capital costs is established under section 1886(g) of the Act, which makes no mention of any add-on payments for a new medical service or technology. Therefore, it is not appropriate to include capital costs in the add-on payments for a new medical service or technology. In the application, the applicant provided a breakdown of the costs of the Argussupreg II System. The total operating cost of the Argussupreg II System is $144,057.50. Under Sec. 412.88(a)(2), we limit new technology add-on payments to the lesser of 50 percent of the average cost of the device or 50 percent of the costs in excess of the MS-DRG payment for the case. As a result, the maximum add-on payment for a case involving the Argussupreg II System for FY 2014 was $72,028.75.

    With regard to the newness criterion for the Argussupreg II System, we considered the beginning of the newness period to commence when the Argussupreg II System became available on the U.S. market on December 20, 2013. Because the 3-year anniversary date of the entry of the Argussupreg II System on the U.S. market will occur in the first half of FY 2017 (December 23, 2016), we proposed to continue new technology add-on payments for this technology for FY 2016.

    Because we are adopting the ICD-10 coding system beginning October 1, 2015, we proposed to identify and make new technology add-on payments for cases involving the Argussupreg II System when one of the following ICD-10-PCS procedure codes is reported: 08H005Z (Insertion of epiretinal visual prosthesis into right eye, open approach); or 08H105Z (Insertion of epiretinal visual prosthesis into left eye, open approach). We stated that the maximum new technology add-on payment for a case involving the Argussupreg II System would remain at $72,028.75 for FY 2016.

    We invited public comments on our proposals.

    We did not receive any public comments on our proposal to continue new technology add-on payments for the Argussupreg II System for FY 2016 or on the coding and payment of this technology. Therefore, we are finalizing our proposal to continue new technology add-on payments for the Argussupreg II System for FY 2016. Because we are adopting the ICD-10 coding system beginning October 1, 2015, we will identify and make new technology add-on payments for cases involving the Argussupreg II System when ICD-10-PCS procedure code 08H005Z or 08H105Z is reported. The maximum new technology add-on payment for a case involving the Argussupreg II System remains at $72,028.75 for FY 2016.

  213. Zilversupreg PTXsupreg Drug Eluting Peripheral Stent

    Cooksupreg Medical submitted an application for new technology add-on payments for the Zilversupreg PTXsupreg Drug Eluting Peripheral Stent (Zilversupreg PTXsupreg) for FY 2014. The Zilversupreg PTXsupreg is intended for use in the treatment of peripheral artery disease (PAD) of the above-the-knee femoropopliteal arteries (superficial femoral arteries). According to the applicant, the stent is percutaneously inserted into the artery(s), usually by accessing the common femoral artery in the groin. The applicant stated that an introducer catheter is inserted over the wire guide and into the target vessel where the lesion will first be treated with an angioplasty balloon to prepare the vessel for stenting. The applicant indicated that the stent is self-expanding, made of nitinol (nickel titanium), and is coated with the drug Paclitaxel. Paclitaxel is a drug approved for use as an anticancer agent and for use with coronary stents to reduce the risk of renarrowing of the coronary arteries after stenting procedures.

    The applicant received FDA approval on November 15, 2012, for the Zilversupreg PTXsupreg. The applicant maintains that the Zilversupreg PTXsupreg is the first drug-eluting stent used for superficial femoral arteries. The technology is currently described by ICD-9-CM procedure code 00.60 (Insertion of drug-eluting stent(s) of the superficial femoral artery).

    In the FY 2014 IPPS/LTCH PPS final rule (78 FR 50583 through 50585), after evaluation of the new technology add-on payment application and consideration of the public comments received, we approved the Zilversupreg PTXsupreg for new technology add-on payments in FY 2014. Cases involving the Zilversupreg PTXsupreg that are eligible for new technology add-on payments are identified by ICD-9-CM procedure code 00.60. As explained in the FY 2014 IPPS/LTCH PPS final rule, to determine the amount of Zilversupreg PTXsupreg stents per case, instead of using the amount of stents used per case based on the ICD-9-CM codes, the applicant used an average of 1.9 stents per case based on the Zilversupreg PTXsupreg Global Registry Clinical Study. The applicant stated in its application that the anticipated cost per stent is approximately $1,795. Therefore, cases of the Zilversupreg PTXsupreg would incur an average cost per case of $3,410.50 ($1,795 x 1.9). Under Sec. 412.88(a)(2), we limit new technology add-on payments to the lesser of 50 percent of the average cost of the device or 50 percent of the costs in excess of the MS-DRG payment for the case. As a result, the maximum add-on payment for a case of the Zilversupreg PTXsupreg was $1,705.25 for FY 2014.

    With regard to the newness criterion for the Zilversupreg PTXsupreg, we considered the beginning of the newness period to commence when the Zilversupreg PTXsupreg was approved by the FDA on November 15, 2012. Because the 3-year anniversary date of the entry of the Zilversupreg PTXsupreg on the U.S. market occurred after FY 2015 (November 15, 2015), in the FY 2015 IPPS/LTCH PPS final rule, we continued new technology add-on payments for this technology for FY 2015 (79 FR 49925). However, for FY 2016, the 3-year anniversary date of the product's entry on the U.S. market (November 15, 2015) occurs in the first half of FY 2016. Therefore, we proposed to discontinue new technology add-on payments for the Zilversupreg PTXsupreg for FY 2016. We invited public comments on this proposal.

    Comment: One commenter requested that CMS extend the new technology add-on payment for the Zilversupreg PTXsupreg for FY 2016.

    Page 49440

    Response: As stated previously, the new technology add-on payment regulations provide that a medical service or technology may be considered new within 2 or 3 years after the point at which data begin to become available reflecting the ICD-9-CM code assigned to the new service or technology (Sec. 412.87(b)(2)). Our practice has been to begin and end new technology add-on payments on the basis of a fiscal year, and we have generally followed a guideline that uses a 6-month window before and after the start of the fiscal year to determine whether to extend the new technology add-on payment for an additional fiscal year. In general, we extend add-on payments for an additional year only if the 3-year anniversary date of the product's entry on the market occurs in the latter half of the fiscal year (70 FR 47362). Consistent with this practice, because the 3-year anniversary date of the product's entry onto the U.S. market will occur during the first half of FY 2016, we are not extending new technology add-on payments for FY 2016.

    After consideration of the public comment we received, we are finalizing our proposal to discontinue new technology add-on payments for the Zilversupreg PTXsupreg for FY 2016 because the technology will no longer be considered new.

  214. CardioMEMSTM HF (Heart Failure) Monitoring System

    CardioMEMS, Inc. submitted an application for new technology add-on payment for FY 2015 for the CardioMEMSTM HF (Heart Failure) Monitoring System, which is an implantable hemodynamic monitoring system comprised of an implantable sensor/monitor placed in the distal pulmonary artery. Pulmonary artery hemodynamic monitoring is used in the management of heart failure. The CardioMEMSTM HF Monitoring System measures multiple pulmonary artery pressure parameters for an ambulatory patient to measure and transmit data via a wireless sensor to a secure Web site.

    The CardioMEMSTM HF Monitoring System utilizes radiofrequency (RF) energy to power the sensor and to measure pulmonary artery (PA) pressure and consists of three components: An Implantable Sensor with Delivery Catheter, an External Electronics Unit, and a Pulmonary Artery Pressure Database. The system provides the physician with the patient's PA pressure waveform (including systolic, diastolic, and mean pressures) as well as heart rate. The sensor is permanently implanted in the distal pulmonary artery using transcatheter techniques in the catheterization laboratory where it is calibrated using a Swan-

    Ganz catheter. PA pressures are transmitted by the patient at home in a supine position on a padded antenna, pushing one button which records an 18-second continuous waveform. The data also can be recorded from the hospital, physician's office or clinic.

    The hemodynamic data, including a detailed waveform, are transmitted to a secure Web site that serves as the Pulmonary Artery Pressure Database, so that information regarding PA pressure is available to the physician or nurse at any time via the Internet. Interpretation of trend data allows the clinician to make adjustments to therapy and can be used along with heart failure signs and symptoms to adjust medications.

    The applicant believed that a large majority of patients receiving the sensor would be admitted as an inpatient to a hospital with a diagnosis of acute or chronic heart failure, which is typically described by ICD-9-CM diagnosis code 428.43 (Acute on chronic combined systolic and diastolic heart failure) and the sensor would be implanted during the inpatient stay. The applicant stated that for safety considerations, a small portion of these patients may be discharged and the sensor would be implanted at a future date in the hospital outpatient setting. In addition, there would likely be a group of patients diagnosed with chronic heart failure who are not currently hospitalized, but who have been hospitalized in the past few months for which the treating physician believes that regular pulmonary artery pressure readings are necessary to optimize patient management. Depending on the patient's status, the applicant stated that these patients may have the sensor implanted in the hospital inpatient or outpatient setting.

    The applicant received FDA approval on May 28, 2014. The CardioMEMSTM HF Monitoring System is currently described by ICD-9-CM procedure code 38.26 (Insertion of implantable pressure sensor without lead for intracardiac or great vessel hemodynamic monitoring).

    After evaluation of the newness, costs, and substantial clinical improvement criteria for new technology payments for the CardioMEMSTM HF Monitoring System and consideration of the public comments we received in response to the FY 2015 IPPS/LTCH PPS proposed rule, we approved the CardioMEMSTM HF Monitoring System for new technology add-on payments for FY 2015 (79 FR 49940). Cases involving the CardioMEMSTM HF Monitoring System that are eligible for new technology add-on payments are identified by ICD-

    9-CM procedure code 38.26 (Insertion of implantable wireless pressure sensor for intracardiac or great vessel hemodynamic monitoring), which was effective October 1, 2011. With the new technology add-on payment application, the applicant stated that the total operating cost of the CardioMEMSTM HF Monitoring System is $17,750. Under Sec. 412.88(a)(2), we limit new technology add-on payments to the lesser of 50 percent of the average cost of the device or 50 percent of the costs in excess of the MS-DRG payment for the case. As a result, the maximum new technology add-on payment for a case involving the CardioMEMSTM HF Monitoring System is $8,875.

    With regard to the newness criterion for the CardioMEMSTM HF Monitoring System, we considered the beginning of the newness period to commence when the CardioMEMSTM HF Monitoring System was approved by the FDA on May 28, 2014. Because the 3-year anniversary date of the entry of the CardioMEMSTM HF Monitoring System on the U.S. market will occur in FY 2017 (May 28, 2017), we proposed to continue new technology add-on payments for this technology for FY 2016.

    Because we are adopting the ICD-10 coding system beginning October 1, 2015, for FY 2016, we proposed to identify and make new technology add-on payments for cases involving the CardioMEMSTM HF Monitoring System using either ICD-10-PCS procedure code 02HQ30Z (Insertion of pressure sensor monitoring device into right pulmonary artery, percutaneous approach) or ICD-10-PCS procedure code 02HR30Z (Insertion of pressure sensor monitoring device into left pulmonary artery, percutaneous approach). We stated that the maximum payment for a case involving the CardioMEMSTM HF Monitoring System would remain at $8,875 for FY 2016.

    We invited public comments on our proposals.

    Comment: Commenters supported CMS' proposal to continue new technology add-on payments for the CardioMEMSTM HF Monitoring System for FY 2016. Commenters also supported CMS'proposal to use ICD-10-PCS procedure codes 02HQ30Z and 02HR30Z when making new technology add-on payments for cases involving the CardioMEMSTM HF Monitoring System.

    Response: We appreciate the commenters' support.

    After consideration of the public comments we received, we are finalizing our proposal to continue new technology add-on payments for the

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    CardioMEMSTM HF Monitoring System for FY 2016. Because we are adopting the ICD-10 coding system beginning October 1, 2015, for FY 2016, we will identify and make new technology add-on payments for cases involving the CardioMEMSTM HF Monitoring System using either ICD-10-PCS procedure code 02HQ30Z (Insertion of pressure sensor monitoring device into right pulmonary artery, percutaneous approach) or ICD-10-PCS procedure code 02HR30Z (Insertion of pressure sensor monitoring device into left pulmonary artery, percutaneous approach). We note that as discussed in section II.G.3. of the preamble of this final rule, CMS determined that there are additional ICD-10-PCS codes describing the insertion of a pressure sensor monitoring that also are appropriate translations for ICD 9 CM procedure code 38.26. These other ICD-10-PCS codes describe the insertion of a pressure sensor monitoring device utilizing an open approach or a percutaneous endoscopic approach (for the right or left pulmonary artery). However, for purposes of new technology add-on payments for cases involving the CardioMEMSTM HF Monitoring System, as stated above, we will identify cases using either ICD-10-PCS procedure code 02HQ30Z (Insertion of pressure sensor monitoring device into right pulmonary artery, percutaneous approach) or ICD-10-PCS procedure code 02HR30Z (Insertion of pressure sensor monitoring device into left pulmonary artery, percutaneous approach). The maximum payment for a case involving the CardioMEMSTM HF Monitoring System will remain at $8,875 for FY 2016.

  215. MitraClipsupreg System

    Abbott Vascular submitted an application for new technology add-on payments for the MitraClipsupreg System for FY 2015. The MitraClipsupreg System is a transcatheter mitral valve repair system that includes a MitraClipsupreg device implant, a Steerable Guide Catheter, and a Clip Delivery System. It is designed to perform reconstruction of the insufficient mitral valve for high-risk patients who are not candidates for conventional open mitral valve repair surgery.

    Mitral regurgitation (MR), also referred to as mitral insufficiency or mitral incompetence, occurs when the mitral valve fails to close completely causing the blood to leak or flow backwards (regurgitate) into the left ventricle. If the amount of blood that leaks backwards into the left ventricle is minimal, then intervention is usually not necessary. However, if the amount of blood that is regurgitated becomes significant, this can cause the left ventricle to work harder to meet the body's need for oxygenated blood. Severity levels of MR can range from grade 1+ through grade 4+. If left untreated, severe MR can lead to heart failure and death. The American College of Cardiology (ACC) and the American Heart Association (AHA) issued practice guidelines in 2006 that recommended intervention for moderate/severe or severe MR (grade 3+ to 4+). The applicant stated that the MitraClipsupreg System is ``indicated for percutaneous reduction of significant mitral regurgitation . . . in patients who have been determined to be at prohibitive risk for mitral value surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease and in whom existing comorbidities would not preclude the expected benefit from correction of the mitral regurgitation.''

    The MitraClipsupreg System mitral valve repair procedure is based on the double-orifice surgical repair technique that has been used as a surgical technique in open chest, arrested-heart surgery for the treatment of MR since the early 1990s. According to the applicant, in utilizing ``the double-orifice technique, a portion of the anterior leaflet is sutured to the corresponding portion of the posterior leaflet using standard techniques and forceps and suture, creating a point of permanent cooptation (``approximation'') of the two leaflets. When the suture is placed in the middle of the valve, the valve will have a functional double orifice during diastole.''

    With regard to the newness criterion, the MitraClipsupreg System received a premarket approval from the FDA on October 24, 2013. The MitraClipsupreg System is indicated ``for the percutaneous reduction of significant symptomatic mitral regurgitation (MR >= 3+) due to primary abnormality of the mitral apparatus (degenerative MR) in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.'' The MitraClipsupreg System became immediately available on the U.S. market following FDA approval. The MitraClipsupreg System is a Class III device, and has an investigational device exemption (IDE) for the EVEREST study (Endovascular Valve Edge-to-Edge Repair Study)--IDE G030061, and for the COAPT study (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Health Failure Patients with Functional Mitral Regurgitation)--IDE G120024. Effective October 1, 2010, ICD-9-CM procedure code 35.97 (Percutaneous mitral valve repair with implant) was created to identify and describe the MitraClipsupreg System technology.

    On August 7, 2014, CMS issued a National Coverage Decision (NCD) concerning Transcatheter Mitral Valve Repair procedures. We refer readers to the CMS Web site at: http://www.cms.gov/medicare-coverage-database/details/nca-tracking-sheet.aspx?NCAId=273 for information related to this NCD.

    After evaluation of the newness, costs, and substantial clinical improvement criteria for new technology payments for the MitraClipsupreg System and consideration of the public comments we received in response to the FY 2015 IPPS/LTCH PPS proposed rule, we approved the MitraClipsupreg System for new technology add-on payments for FY 2015 (79 FR 49946). As discussed in the FY 2015 IPPS/

    LTCH PPS final rule, this approval is on the basis of using the MitraClipsupreg consistent with the NCD. Cases involving the MitraClipsupreg System that are eligible for the new technology add-

    on payments are currently identified by ICD-9-CM procedure code 35.97. The average cost of the MitraClipsupreg System is reported as $30,000. Under section 412.88(a)(2), we limit new technology add-on payments to the lesser of 50 percent of the average cost of the device or 50 percent of the costs in excess of the MS-DRG payment for the case. As a result, the maximum new technology add-on payment for a case involving the MitraClipsupreg System is $15,000 for FY 2015.

    With regard to the newness criterion for the MitraClipsupreg System, we considered the beginning of the newness period to commence when the MitraClipsupreg System was approved by the FDA on October 24, 2013. Because the 3-year anniversary date of the entry of the MitraClipsupreg System on the U.S. market will occur in FY 2017 (October 24, 2016), we proposed to continue new technology add-on payments for this technology for FY 2016.

    Because we are adopting the ICD-10 coding system beginning October 1, 2015, we proposed to identify and make new technology add-on payments for cases involving the MitraClipsupreg System using ICD-10-

    PCS procedure code 02UG3JZ (Supplement mitral valve with synthetic substitute, percutaneous approach). We stated that the maximum

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    payment for a case involving the MitraClipsupreg System would remain at $15,000 for FY 2016.

    We invited public comments on our proposals.

    Comment: Commenters supported CMS' proposal to continue new technology add-on payments for the MitraClipsupreg System for FY 2016. One commenter, the manufacturer, submitted a revised cost analysis. The commenter noted that the MitraClipsupreg System maps to newly created MS-DRGs 273 and 274 (instead of MS-DRGs 250 and 251), the same MS-DRGs as the WATCHMANsupreg System (which is discussed in section II.I.5.f. of the preamble of this final rule). The commenter reported that it conducted an analysis using the supplemental thresholds that CMS discussed in the proposed rule for newly created MS-DRGs 273 and 274 and demonstrated that the MitraClipsupreg System meets the cost criterion because the case-weighted average standardized charge per case exceeded the case-weighted threshold. Therefore, the commenter believed that the MitraClipsupreg System continues to meet all three criteria for new technology add-on payments for FY 2016.

    Response: We appreciate the commenters' support. In the proposed rule, with regard to the cost criterion for the WATCHMANsupreg System, we discussed using supplemental thresholds for newly created MS-DRGs 273 and 274 and posted these supplemental thresholds on the CMS Web site. We note that we are maintaining our current policy, which is to use the thresholds issued with each final rule for the upcoming fiscal year (that is, for FY 2017, we will use the thresholds for the updated MS-DRG assignments as reflected in Table 10 issued with this FY 2016 final rule) when making a determination to continue the add-on payment for those new technologies that were approved for the new technology add-on payment from the prior fiscal year.

    We did not receive any public comments on the coding and payment of the MitraClipsupreg System for FY 2016.

    After consideration of the public comments we received, we are finalizing our proposal to continue new technology add-on payments for the MitraClipsupreg System for FY 2016. Because we are adopting the ICD-10 coding system beginning October 1, 2015, we will identify and make new technology add-on payments for cases involving the MitraClipsupreg System using ICD-10-PCS procedure code 02UG3JZ. The maximum payment for a case involving the MitraClipsupreg System will remain at $15,000 for FY 2016.

  216. Responsive Neurostimulator (RNSsupreg) System

    NeuroPace, Inc. submitted an application for new technology add-on payments for FY 2015 for the use of the RNSsupreg System. (We note that the applicant submitted an application for new technology add-on payments for FY 2014, but failed to receive FDA approval prior to the July 1 deadline.) Seizures occur when brain function is disrupted by abnormal electrical activity. Epilepsy is a brain disorder characterized by recurrent, unprovoked seizures. According to the applicant, the RNSsupreg System is the first implantable medical device (developed by NeuroPace, Inc.) for treating persons diagnosed with epilepsy whose partial onset seizures have not been adequately controlled with antiepileptic medications. The applicant further stated that, the RNSsupreg System is the first closed-loop, responsive system to treat partial onset seizures. Responsive electrical stimulation is delivered directly to the seizure focus in the brain when abnormal brain activity is detected. A cranially implanted programmable neurostimulator senses and records brain activity through one or two electrode-containing leads that are placed at the patient's seizure focus/foci. The neurostimulator detects electrographic patterns previously identified by the physician as abnormal, and then provides brief pulses of electrical stimulation through the leads to interrupt those patterns. Stimulation is delivered only when abnormal electrocorticographic activity is detected. The typical patient is treated with a total of 5 minutes of stimulation a day. The RNSsupreg System incorporates remote monitoring, which allows patients to share information with their physicians remotely.

    With respect to the newness criterion, the applicant stated that some patients diagnosed with partial onset seizures that cannot be controlled with antiepileptic medications may be candidates for the vagus nerve stimulator (VNS) or for surgical removal of the seizure focus. According to the applicant, these treatments are not appropriate for, or helpful to, all patients. Therefore, the applicant believed that there is an unmet clinical need for additional therapies for partial onset seizures. The applicant further stated that the RNSsupreg System addresses this unmet clinical need by providing a novel treatment option for treating persons diagnosed with medically intractable partial onset seizures. The applicant received FDA premarket approval on November 14, 2013.

    After evaluation of the newness, costs, and substantial clinical improvement criteria for new technology payments for the RNSsupreg System and consideration of the public comments we received in response to the FY 2015 IPPS/LTCH PPS proposed rule, we approved the RNSsupreg System for new technology add-on payments for FY 2015 (79 FR 49950). Cases involving the RNSsupreg System that are eligible for new technology add-on payments are currently identified using the following ICD-9-CM procedure codes: 01.20 (Cranial implantation or replacement of neurostimulator pulse generator) in combination with 02.93 (Implantation or replacement of intracranial neurostimulator lead(s)). According to the applicant, cases using the RNSsupreg System would incur an anticipated cost per case of $36,950. Under Sec. 412.88(a)(2) of the regulations, we limit new technology add-on payments to the lesser of 50 percent of the average costs of the device or 50 percent of the costs in excess of the MS-DRG payment rate for the case. As a result, the maximum new technology add-on payment for cases involving the RNSsupreg System is $18,475.

    With regard to the newness criterion for the RNSsupreg System, we considered the beginning of the newness period to commence when the RNSsupreg System was approved by the FDA on November 14, 2013. Because the 3-year anniversary date of the entry of the RNSsupreg System on the U.S. market will occur in FY 2017 (November 14, 2016), we proposed to continue new technology add-on payments for this technology for FY 2016.

    Because we are adopting the ICD-10 coding system beginning October 1, 2015, we proposed to identify and make new technology add-on payments for cases involving the RNSsupreg System using the following ICD-10-PCS procedure code combination: 0NH00NZ (Insertion of neurostimulator generator into skull, open approach) in combination with 00H00MZ (Insertion of neurostimulator lead into brain, open approach). We stated that the maximum payment for a case involving the RNSsupreg System would remain at $18,475 for FY 2016.

    We invited public comments on our proposals.

    Comment: Commenters supported CMS' proposal to continue new technology add-on payments for the RNSsupreg System for FY 2016. One commenter noted that since FY 2015, additional evidence has been published further demonstrating the safety, effectiveness, and durability of the RNSsupreg System. The commenter cited in

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    particular a peer-reviewed article that was published in February 2015 in Neurology, the journal of the American Academy of Neurology. The commenter stated that this article provides interim results of safety and effectiveness from the 7-year, prospective, long-term, follow-up trial for the RNS System.\8\

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

    \8\ Bergey et al., Long-term treatment with responsive brain stimulation in adults with refractory partial seizures. Neurology. 2015 Feb 24;84(8):810-7.

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    In addition, the commenter noted a recently published review and opinion in Nature Reviews Neurology entitled ``Epilepsy: Closing the loop for patients with epilepsy'' (by two epilepsy specialists, Kristl Vonck, MD and Paul Boon, MD) that discusses the positive long-term results of responsive neurostimulation and the promise this therapy brings to a complex patient population with limited treatment options.

    Response: We appreciate the commenters' support and the citations of the additional supporting information.

    We did not receive any public comments on the proposed coding and payment of the RNSsupreg System for FY 2016.

    After consideration of the public comments we received, we are finalizing our proposal to continue new technology add-on payments for the RNSsupreg System for FY 2016. Because we are adopting the ICD-10 coding system beginning October 1, 2015, we will identify and make new technology add-on payments for cases involving the RNSsupreg System using the following ICD-10-PCS procedure code combination: 0NH00NZ (Insertion of neurostimulator generator into skull, open approach) in combination with 00H00MZ (Insertion of neurostimulator lead into brain, open approach). The maximum payment for a case involving the RNSsupreg System will remain at $18,475 for FY 2016.

    5. FY 2016 Applications for New Technology Add-On Payments

    We received nine applications for new technology add-on payments for FY 2016. However, two applications, the Angel Medical Guardiansupreg Ischemia Monitoring Device and Ceftazidime Avibactam (AVYCAZ), were withdrawn from consideration for new technology add-on payments for FY 2016 prior to the publication of this final rule. In addition, in accordance with the regulations under Sec. 412.87(c), applicants for new technology add-on payments must have FDA approval of the technology by July 1 of each year prior to the beginning of the fiscal year that the application is being considered. One applicant did not receive FDA approval for its technology, Idarucizumab, by July 1, 2015, and, therefore, is ineligible for consideration for new technology add-on payments for FY 2016. We are not including the descriptions and discussions of these three applications that were included in the FY 2016 proposed rule in this final rule. We note that we did receive public comments on all three of these applications. However, because the applicant either withdrew its application or the technology is ineligible for new technology add-on payments for FY 2016 because the technology did not receive FDA approval by July 1, 2015, we also are not summarizing or responding to these public comments in this final rule. A discussion of the six remaining applications is presented below.

  217. Blinatumomab (BLINCYTOTM)

    Amgen, Inc. submitted an application for new technology add-on payments for Blinatumomab (BLINCYTOTM), a bi-specific T-cell engager (BiTE) used for the treatment of Philadelphia chromosome-

    negative (Ph-) relapsed or refractory (R/R) B-cell precursor acute-

    lymphoblastic leukemia (ALL), which is a rare aggressive cancer of the blood and bone marrow. Approximately 6,050 individuals are diagnosed with Ph- R/R B-cell precursor ALL in the United States each year, and approximately 2,400 individuals, representing 30 percent of all new cases, are adults. Ph- R/R B-cell precursor ALL occurs when there are malignant transformations of B-cell or T-cell progenitor cells, causing an accumulation of lymphoblasts in the blood, bone marrow, and occasionally throughout the body. As a bi-specific T-cell engager, the BLINCYTOTM technology attaches to a molecule on the surface of the tumorous cell, as well as to a molecule on the surface of normal T-cells, bringing the two into closer proximity and allowing the normal T-cell to destroy the tumorous cell. Specifically, the BLINCYTOTM technology attaches to a cell identified as CD19, which is present on all of the cells of the malignant transformations that cause Ph- R/R B-cell precursor ALL and helps attract the cell into close proximity of the T-cell CD3 with the intent of getting close enough to allow the T-cell to inject toxins that destroy the cancerous cell. According to the applicant, the BLINCYTOTM technology is the first, and the only, bi-specific CD19-directed CD3 T-cell engager single-agent immunotherapy approved by the FDA.

    BLINCYTOTM is administered as a continuous IV infusion delivered at a constant flow rate using an infusion pump. A single cycle of treatment consists of 28 days of continuous infusion, and each treatment cycle followed by 2 weeks without treatment prior to administering any further treatments. A course of treatment consists of two phases. Phase 1 consists of initial inductions or treatments intended to achieve remission followed by additional inductions and treatments to maintain consolidation; or treatments given after remission has been achieved to prolong the duration. During phase 1 of a single treatment course, up to two cycles of BLINCYTOsupreg are administered, and up to three additional cycles are administered during consolidation. The recommended dosage of BLINCYTOTM administered during the first cycle of treatment is 9 mcg per day for the first 7 days of treatment. The dosage is then increased to 28 mcg per day for 3 weeks until completion. During phase 2 of the treatment course, all subsequent doses are administered as 28 mcg per day throughout the entire duration of the 28-day treatment period.

    With respect to the newness criterion, the BLINCYTOTM technology received FDA approval on December 3, 2014, for the treatment of patients diagnosed with Ph- R/R B-cell precursor ALL, and the product gained entry onto the U.S. market on December 17, 2014. As stated in section II.G.1.a. of the preamble of the FY 2016 IPPS/LTCH PPS proposed rule and this final rule, effective October 1, 2015 (FY 2016), the ICD-10 coding system will be implemented. In the proposed rule, we noted that the applicant had applied for a new ICD-10-PCS procedure code at the March 18-19, 2015 ICD-10-CM/PCS Coordination and Maintenance Committee Meeting. In this final rule, we note that the new ICD-10-PCS procedure codes XW03351 (Introduction of Blinatumomab antineoplastic immunotherapy into peripheral vein, percutaneous approach, new technology group 1) and XW04351 (Introduction of Blinatumomab antineoplastic immunotherapy into central vein, percutaneous approach, new technology group1) were established as shown in Table 6B (New Procedure Codes) and will uniquely identify procedures involving the BLINCYTOTM technology. More information on this request and the approval can be found on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/ICD-9-CM-C-and-M-Meeting-Materials.html and the FY 2016 New ICD-10-PCS Codes can be found at the CMS Web site at: http://www.cms.gov/

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    Medicare/Coding/ICD10/2016-ICD-10-PCS-and-GEMs.html.

    In the FY 2010 IPPS/RY 2010 LTCH PPS final rule (74 FR 43813 through 43814), we established criteria for evaluating whether a new technology is substantially similar to an existing technology, specifically: (1) Whether a product uses the same or a similar mechanism of action to achieve a therapeutic outcome; (2) whether a product is assigned to the same or a different MS-DRG; and (3) whether the new use of the technology involves the treatment of the same or similar type of disease and the same or similar patient population. If a technology meets all three of these criteria, it would be considered substantially similar to an existing technology and would not be considered ``new'' for purposes of new technology add-on payments. For a detailed discussion of the criteria for substantial similarity, we refer readers to the FY 2006 IPPS final rule (70 FR 47351 through 47352), and the FY 2010 IPPS/LTCH PPS final rule (74 FR 43813 through 43814).

    With regard to the first criterion, whether a product uses the same or a similar mechanism of action to achieve a therapeutic outcome, we stated in the proposed rule our concern that the mechanism of action of the BLINCYTOTM technology does not appear to differ from those of other bi-specific T-cell engagers, which also attract the cancerous cell within close proximity of a normal T-cell with the intent of allowing the cell to get close enough to inject toxins to destroy the cancerous cell. There are several other BiTEs currently under investigation, including MT110 that are used for the treatment of patients diagnosed with gastrointestinal and lung cancers and are directed towards the EpCAM antigen, as well as MCSP-specific and CD33-

    specific BiTEs used for treating patients diagnosed with melanoma and acute myeloid leukemia, respectively. We believe that the feature that distinguishes the BLINCYTOTM technology from these other bi-

    specific T-cell engagers is that it specifically targets the CD19 cell. However, in the proposed rule, we stated that we are concerned that the specificity of the mechanism of action may not be sufficient to distinguish the BLINCYTOTM technology from other bi-specific T-cell engagers and, therefore, the technology bears substantial similarity to these other BiTEs used as current treatment options for Medicare beneficiaries. Further, we stated that determining that the BLINCYTOTM technology meets the newness criterion based on the specificity of the mechanism of action would set a precedent that a drug employing the same mechanism of action could be considered ``new'' based on such specificity when evaluated under the substantial similarity criterion.

    With respect to the second criterion, whether a product is assigned to the same or a different MS-DRG, the applicant maintained that ICD-9-

    CM diagnosis codes 204.00 (Acute lymphoid leukemia, without mention of having achieved remission) and 204.02 (Acute lymphoid leukemia in relapse) are used to identify patients who may potentially be eligible for treatment using the BLINCYTOTM technology. Using these diagnosis codes, the applicant researched claims data from the FY 2013 MedPAR file and found cases across a wide spectrum of MS-DRGs, not all of which are related to acute lymphoblastic leukemia. According to the applicant, 42.1 percent of all cases representing patients diagnosed with Ph- R/R B-cell precursor ALL were assigned to 238 MS-DRGs. Therefore, we believe that potential cases involving the BLINCYTOTM technology may be assigned to the same MS-DRG(s) as other cases involving bi-specific T-cell engagers used to treat patients with leukemia.

    With respect to the third criterion, whether the new use of the technology involves the treatment of the same or similar type of disease and the same or similar patient population, the applicant maintained in its application that the standard treatment for patients diagnosed with Ph- R/R B-cell precursor ALL currently requires the use of multiple, intensive chemotherapy treatment drugs in combination to induce remission in order to allow the patient the opportunity to proceed to allogenic hematopoietic stem cell transplant (alloHSCT), which is the next stage in the course of treatment and the only known curative option. The applicant asserted that the BLINCYTOTM technology is not substantially similar to other treatment options because it does not involve the treatment of the same, or similar, type of diseases or the same, or similar, patient population. The applicant stated that, although chemotherapy is a successful treatment option to induce remission in patients diagnosed with Ph- R/R B-cell precursor ALL, many of these patients relapse or stop responding to this standard treatment and, therefore, are unable to proceed to alloHSCT, the next stage of treatment. Moreover, chemotherapy toxicities can be cumulative. Therefore, the commenter stated, patients who have received intensive treatments may not be eligible for further intensive chemotherapy treatments and, therefore, are unable to proceed to alloHSCT. The applicant asserted that the BLINCYTOTM technology is an anti-cancer immunotherapy that has shown to be effective in the treatment of a patient population in which chemotherapy has not been successful. Moreover, the applicant asserted that, as an anti-cancer immunotherapy, the BLINCYTOTM technology does not demonstrate the cumulative side-effects typically associated with chemotherapy treatments and, therefore, is a treatment option available to patients who are not eligible for further chemotherapy treatments based on the risks associated with cumulative toxicities. However, in the proposed rule, we stated our concern that this specific patient population is not necessarily distinguishable from the overall patient population of individuals diagnosed with Ph- R/R B-cell precursor ALL, and we are unsure how to identify these patients using administrative claims data.

    In summary, we stated in the proposed rule that the BLINCYTOTM technology may be similar to other approved technologies currently available to treat the same patient population and medical disorders and, therefore, may not meet the newness criterion. In addition, we stated that the specific patient population targeted by the applicant may not be sufficiently distinguishable from the overall patient population that may be eligible for treatment using options that are currently available for these types of medical disorders. We invited public comments on if, and how, the BLINCYTOTM technology meets the newness criterion.

    Comment: The applicant submitted public comments that responded to CMS' concerns presented in the proposed rule. With regard to CMS' concern that the BLINCYTOTM technology's mechanism of action does not appear to differ from other bi-specific T-cell engagers, the applicant emphasized that there are no other FDA-approved bi-specific T-cell engager constructs currently marketed and readily available to Medicare beneficiaries. Therefore, the applicant stated that there are no previously available technologies to use as comparators for determining whether BLINCYTOTM bears a substantial similarity to other bi-specific T-cell engagers. Furthermore, the applicant believed that the BLINCYTOTM technology's mechanism of action is unique and distinguishable from all other FDA-

    approved therapies because

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    it redirects the patient's immune system toward the cancerous cells, which leads to the specifically targeted destruction of these cells. The applicant noted that no other FDA-approved anti-cancer immunotherapy redirects the patient's immune system in such a manner and, therefore, the novelty of the BLINCYTOTM technology's bi-specific T-cell engager mechanism of action extends beyond the target antigen specificity. Therefore, the applicant disagreed with CMS that approving new technology add-on payments for this technology would set a precedent in which a drug employing the same mechanism of action could be considered new based on the specificity of its target antigen.

    With regard to CMS' concern that potentially eligible cases involving the BLINCYTOTM technology may be assigned to the same MS-DRG(s) as other cases involving target therapy used to treat patients diagnosed with leukemia, the applicant reiterated that there are currently no other FDA-approved bi-specific T-cell engager constructs available on the U.S. market to treat any patients, including Medicare beneficiaries, who have been diagnosed with Ph- R/R B-cell precursor ALL. As such, the applicant contended that potential cases eligible for the BLINCYTOTM would not be assigned to the same MS-DRG(s) as other cases involving other targeted therapies.

    With regard to CMS' concern that the specific population of patients identified by the applicant that may be eligible for treatment using the BLINCYTOTM technology (that is, patients who are ineligible for chemotherapy or for whom chemotherapy has not been successful) is not necessarily distinguishable from the overall patient population of individuals diagnosed with Ph- R/R B-cell precursor ALL, the applicant asserted that the approval of the new unique ICD-10-PCS procedure codes to be used to identify cases involving the BLINCYTOTM technology corroborates the recognizable distinction between the specific patient populations. The applicant believed that, if the BLINCYTOTM technology is approved for new technology add-on payments, CMS would be able to use claims data reporting these new ICD-10-PCS procedure codes to distinguish the population of patients treated with the BLINCYTOTM technology from the broader population of patients diagnosed with Ph- R/R B-cell precursor ALL by using these specific new codes on inpatient hospital claims when the codes become effective October 1, 2015.

    Response: We appreciate the details and input provided by the applicant in response to our concerns. We also acknowledge that new ICD-10-PCS procedure codes have been approved to uniquely identify procedures that involve the BLINCYTOTM technology, and that these procedure codes may ultimately be used to distinguish the specific patient population from the overall patient population of individuals diagnosed with Ph- R/R B-cell precursor ALL. After considering the additional information submitted by the applicant in response to our concerns, which supported the technology's uniqueness and documented the lack of an equivalent treatment option for patients diagnosed with Ph- R/R B-cell precursor ALL, who may be ineligible for current treatment options, we agree with the applicant that the BLINCYTOTM technology is not substantially similar to other technologies currently available that also are used in the treatment of patients diagnosed with the same or similar types of conditions. We believe that the BLINCYTOTM technology uses a different mechanism of action than other similar technologies, eligible cases involving treatment using the BLINCYTOTM technology would be grouped to a different MS-DRG than those cases treated with similar technologies, and the BLINCYTOTM technology would be used in the treatment of a different patient population than those currently treated with existing technologies. Therefore, we believe that the BLINCYTOTM technology meets the newness criterion.

    Comment: Several commenters, including medical specialty societies, believed that the BLINCYTOTM technology meets the newness criterion. The commenters agreed with the applicant's assertion that there are currently no other bi-specific T-cell engager constructs that are available on the U.S. market, and disagreed with CMS' comparisons between the applicant's technology and products currently approved or under investigation. One commenter stated that it is particularly notable that the BLINCYTOTM technology is the first FDA-

    approved drug to be used in immunotherapy for the treatment of cancer. The commenter noted that, while other bi-specific T-cell engager constructs are in the development stages, these products have not reached the advanced stages of development, whereas the BLINCYTOTM technology is currently FDA-approved and the subject of phase III clinical trials for the treatment of patients diagnosed with Ph- R/R B-cell precursor ALL. Some commenters believed that the relevant comparison analysis conducted for new technology add-

    on payment eligibility must be related to treatments that are currently available to Medicare beneficiaries. The commenters stated that it is inappropriate to rely upon comparison analysis that compares a candidate for new technology add-on payments, which requires the technology to have FDA approval as a condition, to technologies or treatments that may potentially become available in the future or that are currently under investigation, and sets an impossible standard to achieve that is also inconsistent with CMS' regulations.

    Response: We appreciate the commenters' input. We agree with the commenters that new technology add-on payments are intended to recognize the cost of new items that are not reflected in the Medicare claims data used to set payment rates for MS-DRGs. The costs of treatment options that are currently under development and not available on the U.S. market or to Medicare beneficiaries would not be reflected in the Medicare claims data used to set the payment rates for MS-DRGs. Therefore, these treatment options are not an appropriate comparator for technologies being considered for approval under the new technology add-on payment policy. After considering the additional information submitted by the applicant and the input from other commenters, we have determined that the BLINCYTOTM technology meets the newness criterion.

    As we discussed in the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24432), with respect to the cost criterion, the applicant researched claims data in the FY 2013 MedPAR file, which contained inpatient hospital discharges from October 1, 2012, to September 30, 2013, and identified cases reporting ICD-9-CM diagnosis codes 204.00 (Acute lymphoid leukemia, without mention of having achieved remission) and 204.02 (Acute lymphoid leukemia in relapse), which represent patients who may potentially be eligible for treatment using the BLINCYTOTM technology. The applicant found 2,649 cases across 246 MS-DRGs, including MS-DRGs 834 through 836 (Acute Leukemia without Major Operating Room Procedure, with MCC, with CC, and without CC/MCC, respectively) and MS-DRGs 837 through 839 (Chemotherapy with Acute Leukemia as Secondary Diagnosis, with MCC, with CC, and without CC/MCC, respectively), which represent approximately 48.1 percent of all cases with patients diagnosed with Ph- R/R B-

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    cell precursor ALL. The applicant also found that MS-DRG 809 (Major Hematological and Immunologic Diagnoses Except Sickle Cell Crisis and Coagulations Disorders with CC) and MS-DRG 871 (Septicema or Severe Sepsis without Mechanical Ventilation 96+ Hours with CC) contained cases that further represent 9.8 percent of all cases representing patients diagnosed with Ph- R/R B-cell precursor ALL. The cases assigned to the remaining 238 MS-DRGs represent a combined 42.1 percent of all cases representing patients diagnosed with Ph- R/R B-cell precursor ALL, with no single MS-DRG containing cases representing more than 2.0 percent of all cases representing patients diagnosed with Ph- R/R B-cell precursor ALL. The applicant also noted that when identifying cases that may be eligible for the BLINCYTOTM technology, it excluded any claims for discharges paid by Medicare Advantage plans, as well as any claims submitted by Medicare PPS-exempt cancer hospitals.

    Because the applicant was unable to provide a single estimate of the charges that would be avoided by using the BLINCYTOTM technology (that is, additional charges incurred during treatment using other technologies), the applicant conducted its own cost analysis using two scenarios for each group of MS-DRGs. The first scenario assumed that 50 percent of the charges for drugs would be eliminated by using the BLINCYTOTM technology, and the second scenario assumed that 75 percent of the charges for drugs would be eliminated. The applicant further conducted sensitivity analyses for each of the top eight MS-DRGs containing cases eligible for the BLINCYTOTM technology, as well as a sensitivity analysis for all of the other MS-DRGs outside of the top eight to which eligible cases mapped. The applicant then examined the average case-weighted standardized charge per case and the average case-weighted threshold amount for all 2,649 cases identified during FY 2013 across all 246 MS-

    DRGs, and for 1,533 cases during FY 2013 across the top 8 MS-DRGs to demonstrate that the technology meets the cost criterion.

    Under the analysis' first scenario, 50 percent of the charges for drugs incurred by using other technologies were removed in order to exclude the charges associated with the use of these technologies. The applicant determined an average case-weighted threshold amount of $60,278 for the 2,649 Ph- R/R B-cell precursor ALL cases in the 246 MS-

    DRGs identified using the thresholds in Table 10 in the FY 2015 IPPS/

    LTCH PPS final rule. The applicant also determined an average case-

    weighted standardized charge per case of $245,006, or $184,728 above the average case-weighted threshold amount. For the subset of 1,533 cases that mapped to the top 8 MS-DRGs, the applicant determined an average case-weighted threshold amount of $65,478 using the threshold in Table 10 in the FY 2015 IPPS/LTCH PPS final rule. The applicant also determined an average case-weighted standardized charge per case of $249,354, or $183,876 above the average case-weighted threshold amount. Based on the applicant's analyses, we believe that the BLINCYTOTM technology meets the cost criterion under the first scenario.

    Under the second scenario, the applicant removed 75 percent of charges for drugs incurred by using other technologies in order to exclude the charges associated with the use of these technologies. The applicant determined an average case-weighted threshold amount of $60,278 for the 246 MS-DRGs identified using the thresholds from Table 10 in the FY 2015 IPPS/LTCH PPS final rule. The applicant determined an average case-weighted standardized charge per case of $239,321, or $179,043 above the average case-weighted threshold amount. For the subset of 1,533 cases that mapped to the top 8 MS-DRGs, the applicant determined an average case-weighted threshold amount of $65,478 using the thresholds from Table 10 in the FY 2015 IPPS/LTCH PPS final rule. The applicant determined an average case-weighted standardized charge per case of $242,423, or $176,945 above the average case-weighted threshold amount. Based on the applicant's analyses, we believe that the BLINCYTOTM meets the cost criterion under the second scenario.

    In conducting the above analyses, the applicant summarized the charges from the claims it identified and standardized the charges using an unspecified data source. The applicant then inflated all charges from FY 2013 to FY 2015 using the 10.4427 percent inflation factor used by CMS to update the FY 2015 outlier threshold. In determining the costs for the technology per case, the applicant also assumed that the BLINCYTOTM technology would be administered for 28 days during each inpatient stay. The applicant also assumed a hospital markup of 2.0 percent, and applied this amount to its estimated charges per case.

    In the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24432 through 24433), we presented three concerns regarding the applicant's methodology and assumptions used in its cost analyses. We stated that the applicant did not specify whether it used the FY 2015 IPPS final rule impact file or another data source to standardize the charges per case for this technology. We also stated our concern that the applicant did not provide a basis for the hospital markup assumed when conducting its cost analyses. Unless the applicant provided this information, we stated that we are unable to determine whether the cost of the technology per case has been calculated appropriately. Moreover, we stated our concern that including charges representative of a full 28-

    day treatment cycle is not appropriate for the purpose of calculating the charges associated with the BLINCYTOTM technology in order to determine whether the technology meets the cost criterion. According to the applicant, clinical trial data demonstrate that there are large subsets of patients who require inpatient care for the full 28-day treatment cycle because of the extreme clinical conditions relating to patients diagnosed with Ph- R/R B-cell precursor ALL. However, the applicant also conceded that only 25 percent of patients enrolled in the U.S. clinical trial were hospitalized for the full 28-

    day treatment cycle, and only 38 percent of these patients were over the age of 65. This caused us concern regarding whether the methodology used by the applicant in its cost analysis is appropriate.

    We invited public comments on if, and how, the BLINCYTOTM technology meets the cost criterion, specifically in regard to our concerns related to the applicant's methodology.

    Comment: The applicant submitted further information in response to CMS' concerns. The applicant indicated that it used the FY 2015 IPPS final rule impact file and other instructions included in Technical Appendix B of the FY 2016 new technology add-on payment application to standardize the charges per case for potentially eligible cases for the BLINCYTOTM technology representing patients diagnosed with Ph- R/R B-cell precursor ALL under all of the scenarios. The applicant also provided more information regarding the basis of its markup values used when conducting sensitivity analyses to demonstrate that the BLINCYTOTM technology meets the cost criterion. Specifically, the applicant stated that it used a markup of 100 percent, which is a cost-to-charge ratio (CCR) of 0.5, and further noted that the charges for the BLINCYTOTM technology would be included in the pharmacy charge category on an inpatient hospital's claim. The applicant identified the national average cost-to-charge ratio of

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    0.192 for the pharmacy charge category that was calculated in the FY 2015 IPPS/LTCH PPS final rule. The applicant stated that this CCR indicated that charges in this category were 420 percent higher than the costs. However, the applicant did not believe that a 420-percent markup was appropriate for the purposes of new technology add-on payment MS-DRG case-weighted threshold assessment for the cases eligible for the BLINCYTOTM technology. Therefore, the applicant indicated that it reverted to the use of a more conservative markup of 100 percent in its analyses for eligibility for new technology add-on payments to determine the average case-weighted standardized charges per case. The applicant noted that, if it were to have used the national average markup for the pharmacy charge center of 420 percent, the charges associated with the BLINCYTOTM technology would be significantly higher than that which is indicated in its analyses, further exceeding the MS-DRG case-weighted threshold amount and demonstrating that the BLINCYTOTM technology meets the cost criterion.

    Furthermore, the applicant maintained that including charges representative of a full 28-day treatment cycle is appropriate for the purpose of calculating the charges associated with the BLINCYTOTM technology. However, the applicant indicated that it conducted additional sensitivity analyses across both of the original scenarios used in the application in which it assumed no hospital markup on the charges associated with the BLINCYTOTM technology to demonstrate the standardized charges per case under different scenarios for the variable number of inpatient days; a scenario for standardized charges per case using the full 28 inpatient days, standardized charges per case using the mean total inpatient days for cycle 1 (21.2 days), and standardized charges per case using the mean total inpatient days per cycle across all cycles (16.2 days). Based on the results of these sensitivity analyses, the applicant continued to believe that the BLINCYTOTM technology meets the cost criterion, regardless of the number of assumed inpatient days and the associated charge markup. The applicant determined that, prior to the inclusion of any charges associated with the BLINCYTOTM technology, the case-weighted average standardized charge per case under all scenarios exceeds the average case-weighted threshold amounts for the respective MS-DRGs, further demonstrating that the target cases potentially eligible for the BLINCYTOTM technology have significantly higher costs to provide the standard of care.

    Response: We appreciate the applicant's submittal of the additional information and input. After reviewing the sensitivity analyses included in the original application and subsequent analyses included in the applicant's public comment, we have determined that the BLINCYTOTM technology meets the cost criterion.

    As discussed in the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24433 and 24434), with respect to the substantial clinical improvement criterion, the applicant asserted that the BLINCYTOTM technology represents a substantial clinical improvement for the treatment of patients diagnosed with Ph- R/R B-cell precursor ALL because it offers a treatment option for patients who may be unresponsive to currently available options for treatment, decreases the rate of subsequent therapeutic interventions for patients who might not have otherwise achieved remission, and reduces mortality. The applicant provided data analysis results from four sources to demonstrate that the technology represents a substantial clinical improvement. These sources include a historical literature search, a model-based meta-analysis (Study 118427), a historical comparator data (Study 20120310), and a pivotal clinical trial (Study MT 103-211). We summarize the results from each of these sources below.

    The historical literature search revealed that superior regimens among currently used chemotherapeutic options result in a complete remission rate ranging from 18.0 percent to 38.6 percent, a median overall survival rate for patients experiencing early first relapse (TM pivotal clinical trial. Therefore, the applicant conducted a model-based meta analysis (Studies 118427 and 119384), and a historical comparator study (Study 20120310) to account for these differences.

    In the model-based meta analysis (MBMA), the endpoints of complete remission (CR), duration of complete remission (DCR), and overall survival (OS) rate models were used to predict the efficacy of the BLINCYTOTM technology in cases representing patients diagnosed with Ph- R/R B-cell precursor ALL relative to patients treated using existing therapies. Simulations based on the MBMA for adult patients diagnosed with Ph- R/R B-cell precursor ALL projected a poor outcome with existing salvage therapies, and a significant increase in the proportion of CR, DCR, and OS rates in a population with the same summary prognostic factors as those enrolled in the BLINCYTOTM study MT103-211. For adult patients diagnosed with Ph- R/R B-cell precursor ALL who were treated with existing salvage therapies and having the same summary prognostic factors as those enrolled in the BLINCYTOTM study MT 103-211, the projected proportion of CR was 0.121 (95 percent CI: 0.041 to 0.341), the median DCR rate was 4.9 months (95 percent CI: 2.5 to 9.2 months), and the median OS rate was 3.9 months (95 percent CI: 3.0 to 4.7 months). For adult patients diagnosed with Ph- R/R B-cell precursor ALL having the same summary prognostic factors as those enrolled in the BLINCYTOTM study MT 103-211, treatment using the BLINCYTOTM technology when compared with existing salvage therapies is expected to have an odds ratio for proportion of CR of 3.50 (95 percent CI: 1.63 to 8.40), a hazard ratio for DCR of 0.53 (95 percent CI: 0.30 to 0.89), and a hazard ratio for OS of 0.60 (95 percent CI: 0.47 to 0.76). The applicant maintained that these results suggest that the BLINCYTOTM technology is associated with a reduced mortality rate and improved clinical outcomes when compared to standard chemotherapy treatment options.

    A historical comparator study was also conducted to obtain patient-level data for standard of care treatment options for patients experiencing early first relapse, refractory relapse after HSCT, and second or greater relapse in the same patient population as targeted in the BLINCYTOTM pivotal clinical trial. Study 20120310 was a retrospective pooled analysis of historical data available from 1990 to 2014 on hematological remission and survival rates among patients diagnosed with Ph- R/R B-cell precursor ALL who were treated with standard of care therapies. The primary study endpoint was CR following relapse or salvage treatment; and secondary endpoints included estimates of OS rates, RFS rates, and the proportion of patients

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    receiving alloHSCT. The weighted median OS rate for 1,112 patients based on available data was 3.3 months (95 percent CI: 2.8 to 3.6 months) and was calculated from the start of the last salvage treatment or the first relapse (if start of the last salvage date was unavailable) until the time of death. The weighted OS rate at 6 and 12 months was 30 percent (95 percent CI: 27 percent to 34 percent) and 15 percent (95 percent CI: 13 percent to 18 percent), respectively. Among the patients who achieved CR based on available data (108 patients), the weighted median RFS rate was 5.0 months (95 percent CI: 1.2 to 6.6 months). Among the 808 patients who received alloHSCT after salvage therapy based on available data, 18 percent (95 percent CI: 15 percent to 21 percent) received alloHSCT following the last line of salvage therapy, and among patients who achieved CR, 7 percent (95 percent CI: 5 percent to 9 percent) received alloHSCT. The applicant maintained that these results highlight the poor health care outcomes for patients treated with standard chemotherapy and that BLINCYTOTM represents a significant improvement.

    BLINCYTOTM study MT 103-211 is a pivotal clinical study providing efficacy data for the BLINCYTOTM technology used for the treatment of adult patients diagnosed with Ph- R/R B-cell precursor ALL. It is a phase 2, single-arm study that included a particularly difficult patient population to treat consisting of patients diagnosed with--Ph- R/R B-cell precursor ALL who experienced either: (1) R/R after remission during 12 months or less of the first salvage treatment; (2) R/R after the first salvage treatment; or (3) R/R within 12 months after receiving alloHSCT. The primary endpoint was the rate of CR plus CRh within the first 2 cycles of treatment using the BLINCYTOTM technology. The key secondary endpoints include best overall response within 2 cycles of treatment using the BLINCYTOTM technology, RFS, time of hematological relapse, OS rates, and the proportion of patients eligible for alloHSCT who underwent the procedure after receiving treatment using the BLINCYTOTM technology. An analysis of data from the pivotal trial showed that 40 percent of patients treated with the BLINCYTOTM technology who achieved CR or CRh were able to proceed to alloHSCT. A secondary analysis from the pivotal study found that in patients who achieved CR or CRh and had a minimal residual disease assessment during the first 2 cycles, the MRD response rate (little or no evidence of disease even at the molecular level) was 82.2 percent. The applicant asserted that this finding is significant because MRD is often a harbinger of relapse and a poor prognostic factor for patients diagnosed with Ph- R/R B-cell precursor ALL.

    We stated in the proposed rule our concern that the data provided from the clinical studies are not sufficient to demonstrate that the BLINCYTOTM technology meets the substantial clinical improvement criterion. For example, the BLINCYTOTM study MT 103-211 was not randomized or blinded, and was comprised of a small sample group of 189 patients with a median age of 39 years. We further stated our concern that the sample group studied during the clinical trial is not appropriate to determine if the technology represents a substantial clinical improvement in treatment options available for the Medicare patient population. Moreover, we stated our concern that meaningful conclusions cannot be drawn from the results of this study because of the lack of a control group.

    With regard to the applicant's assertion that the BLINCYTOTM technology offers a treatment option for patients who may be unresponsive to currently available treatment modalities, the applicant specifically focused on how the BLINCYTOTM technology represents a treatment option for a patient population in which chemotherapy has proven to be unsuccessful, or for whom intensive chemotherapy treatment is not possible because of the risks associated with exposure to cumulative toxicities. The applicant believed that the MBMA, the historical comparator study, and the BLINCYTOTM study MT 103-211, which is a pivotal clinical trial sufficiently isolate this patient population in order to measure specific health care outcomes. We agreed with this assertion. However, we stated our concerns with the isolated patient population are that it is comprised of and represents a small sample group of patients whose age demographic is much younger than the age demographic of eligible Medicare beneficiaries.

    The applicant also asserted that the BLINCYTOTM technology decreases the rate of subsequent therapeutic interventions for patients who might not have otherwise achieved remission. In other words, because treatment with the BLINCYTOTM technology appears to increase the possibility of some patients achieving remission, the applicant maintained that these patients would receive fewer therapeutic interventions and become eligible to receive alloHSCT. We stated that we believe that it is difficult to determine what services and therapeutic interventions these patients would have required if they had not achieved remission, and we are not convinced that treatment using the BLINCYTOTM technology leads to a decrease in additional therapeutic interventions. In the proposed rule, we also noted that patients who successfully achieve remission proceed to alloHSCT and, therefore, receive a different set of subsequent therapeutic interventions.

    With regard to the applicant's assertion that the BLINCYTOTM technology reduces mortality rates, we noted that the applicant did not directly capture mortality rates as an endpoint in the BLINCYTOTM pivotal study (MT 103-211), although mortality was analyzed during the other three studies that support the new technology add-on payment application. We noted that the data and the MBMA's results included with the technology's application used an OS odds ratio as a measure of mortality, and were developed from 18 studies published between January 1995 and December 2012. We stated our concern that relying on the results of data using a measure of mortality that is contingent upon studies completed in the 1990s presents a limitation in regard to the methodology used in the applicant's analysis. Advances in overall oncology care over the past 2 decades may invalidate the patient population represented in these studies as a comparison group. Therefore, we stated that we find it difficult to attribute the reduced mortality rate and improved clinical outcomes revealed by these studies to the efficacy of the BLINCYTOTM technology.

    We invited public comments on if, and how, the BLINCYTOTM technology meets the substantial clinical improvement criterion, specifically in regard to our specified concerns.

    Comment: The applicant submitted public comment in response to CMS' concerns presented in the proposed rule which asserted that the sample size and lack of a control arm in the BLINCYTOTM study MT 103-211is due to the rarity and fatality of Ph- R/R B-cell precursor ALL, which made it difficult to find patients to participate in the trials. Nevertheless, the applicant stated that the BLINCYTOTM study MT 103-211 is the largest Ph- R/R B-cell precursor ALL clinical trial reported to date, and was conducted within the limits of its capabilities because larger studies can only be conducted by national or international cooperative study groups. The applicant also

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    maintained that the sample size is representative of the Medicare patient population who have been diagnosed with Ph- R/R B-cell precursor ALL in relapse in spite of the median age of 39 years, and patients who were Medicare beneficiaries due to disability. Moreover, the applicant noted that MedPAR data demonstrate that 60 percent of the 479 inpatient stays for patients diagnosed with Ph- R/R B-cell precursor ALL in relapse in FY 2014 were Medicare patients under the age of 65. In addition, the applicant pointed out that single-arm trials are common in Phase II testing, especially when there is a low-

    volume patient population with patients who have very poor prognosis, such as the patient population represented in the BLINCYTOTM study MT 103-211.

    According to the applicant, the design of the pooled analysis of historic data provides a viable measure to determine that the BLINCYTOTM technology represents a substantial clinical improvement as compared to characteristically matched patients in a control arm that were treated with other currently available options that may not be appropriate or for which a patient's status prohibits eligibility. The applicant also conducted propensity score analyses to further investigate and support historical data that was used as a comparator and found that the majority of patients in Study 20120310 were diagnosed and treated in the year 2000 or later. Moreover, the applicant believed that the results of the majority of propensity score analyses demonstrated an improvement in overall survival (OS) compared to standard of care chemotherapy. Further, the applicant defended the weighted value of outcome of OS rates in the BLINCYTOTM study MT103-211 as a commonly used endpoint in oncology trials, and a more clinically meaningful endpoint than mortality rates given the rapidly progressive and fatal nature of Ph- R/R B-cell precursor ALL diagnoses. The applicant asserted that CMS should not use, as a metric to determine if the BLINCYTOTM represents a significant clinical improvement, that additional therapeutic interventions associated with alloHSCT are available, given that alloHSCT is the only way to provide patients with a potential cure for diagnoses of Ph- R/R B-cell precursor ALL.

    Response: We appreciate the applicant's submittal of the additional information and the explanation of the study design and endpoints in light of the small and rare population of patients diagnosed with Ph- R/R B-cell precursor ALL. We agree with the applicant that, in view of the MedPAR data and the difficulty in finding enough patients to include in a trial and a comparator arm, the sample group studied during the BLINCYTOTM MT 103-211 pivotal clinical trial sufficiently isolates the patient population that the BLINCYTOTM technology is intended to treat. We also agree with the applicant that, given the challenges of conducting a trial with a control arm and the use of historical comparator data, the BLINCYTOTM study MT 103-211 is a reasonable study to show substantial clinical improvement at this junction. However, if approved for new technology add-on payments, we would continue to monitor ongoing Phase III studies to determine if the substantial clinical improvement demonstrated in the BLINCYTOTM study MT 103-211 continues to exist.

    Comment: Several commenters believed that the BLINCYTOTM technology demonstrates significant clinical improvement over existing therapies, and stated that patients who have not responded positively to other treatments have been able to benefit from treatment using the BLINCYTOTM technology and its use creates a bridge to alloHSCT, possibly recognized as a transplant procedure that proves to be a potentially curative treatment. While corroborating the applicant's statements regarding the design of the BLINCYTOTM MT103-211 pivotal trial, one commenter pointed out that a response rate of 43 percent complete remission or complete remission with partial hematologic recovery (CR/CRh) as achieved in the BLINCYTOTM study MT103-211 is impressive using a population of patients diagnosed with relapsed Ph- R/R B-cell precursor ALL. Other commenters acknowledged that, while the BLINCYTOTM has its own set of unique toxicities, such as cytokine release syndrome and neurotoxicity, these conditions are severe in only a small minority of patients. Another commenter stated that its experience with most patients has proven that the use of the BLINCYTOTM technology is well tolerated, and its effects positively contrast to the severe side effects associated with multi-agent chemotherapy salvage regiments that these patients would otherwise experience if access to treatment with the BLINCYTOTM technology were not available. The commenter further noted that, if patients treated using the BLINCYTOTM technology respond positively and it is well-

    tolerated, the patient has the option of becoming a candidate for alloHSCT. As a result, the commenter pointed out that positive response to treatment using the BLINCYTOTM lessens the need for patient's excessive exposure to toxic multi-agent chemotherapy, which has a lower response rate and the potential to cause complications that can become a preventative for these patients from proceeding to alloHSCT.

    Response: We appreciate the applicant's additional information and the commenters' input. As noted by one commenter, we recognize that a 43 percent complete or partial remission rate is impressive using a small sample size of a population of patients diagnosed with Ph- R/R B-

    cell precursor ALL. We also acknowledge that the treatment of patients using currently available combination chemotherapy, or the standard treatment for this disease, has an equivalent or lower rate of complete or partial remission, as well as excessively exposes patients to toxicities that may often be severe. Therefore, we believe that the BLINCYTOTM technology offers a treatment option for Medicare beneficiaries that represents a substantial clinical improvement over existing treatment options for patients who are unresponsive to currently available treatment options and allows many patients the opportunity to access alternative less invasive options, and also provides a bridge to alloHSCT, the only potentially curative option for patients who have been diagnosed with Ph- R/R B-cell precursor ALL. We agree with the commenters that the BLINCYTOTM technology represents a substantial clinical improvement over existing technologies in a patient population diagnosed with Ph- R/R B-cell precursor ALL, or whose only other treatment option for bridging to alloHSCT has potentially worse outcomes and excessive exposure to toxicities.

    After consideration of the public comments we received, we have determined that the BLINCYTOTM technology meets all of the criteria for approval of new technology add-on payments. Therefore, we are approving new technology add-on payments for the BLINCYTOTM technology for FY 2016. Cases involving the BLINCYTOTM technology that are eligible for new technology add-on payments will be identified by ICD-10-PCS procedure codes XW03351 or XW04351.

    Comment: Although the applicant considered the cost and expected use based on a variable number of days for treatment in its costs analyses, the applicant recommended that CMS consider and use the cost of the full 28-day inpatient treatment cycle as the

    Page 49450

    expected length of treatment when determining the maximum new technology add-on payment for cases involving the BLINCYTOTM rather than the average cost of lesser number of days used as other variables. The applicant noted that a single treatment cycle using the BLINCYTOTM consists of 28 days of continuous infusion, and each cycle of treatment is separated by a 2-week treatment-free interval. The applicant recommended that the initial dose of BLINCYTOTM in the first cycle consist of 9 mcg/day for week 1 (first 7 days) of treatment and the dose is increased to 28 mcg/day starting at week 2 through week 4 of the first cycle. The applicant further stated that all subsequent cycles are recommended to be dosed at 28 mcg/day throughout the entire 28-day treatment period. As further explained by the applicant, for each cycle of therapy, a patient will receive one vial (35 mcg) of BLINCYTOTM per day over the entire 28-day treatment period.

    According to the applicant, if the maximum new technology add-on payment for cases involving the BLINCYTOTM is capped at a level less than 50 percent of the estimated costs of the full 28-day inpatient treatment cycle, the actual add-on payment would be well below the cost of care for some patients. The applicant believed that if CMS set the maximum add-on payment amount based on the full 28-day treatment cycle, it would avoid the risk of underpaying or overpaying for cases involving the BLINCYTOTM or cases not performed in the inpatient setting and paid for under the IPPS that have fewer inpatient days. The applicant explained that during the treatment cycle using the BLINCYTOTM, infusion bags are changed every 24 to 48 hours and hospitals would only be charged for the number of bags of BLINCYTOTM that are used during the inpatient stay under the IPPS and when the product is provided while the patient is admitted. Therefore, for those patients who have an inpatient length of stay that is shorter than the 28-day treatment cycle, the applicant stated that the add-on payment would be based only on the costs associated with the number of days that the patient received treatment using the BLINCYTOTM technology in the inpatient setting. The applicant stated that CMS would not be paying the maximum add-on payment amount in those cases and pointed out that CMS would only pay the maximum add-on payment amount for cases that require the patient to remain in the inpatient setting in order to receive treatment using the BLINCYTOTM technology for the entire 28-day treatment cycle.

    The applicant stated that it recognized that CMS may be concerned that it may not be able to differentiate which charges on claims should trigger eligibility for the new technology add-on payment. In addition, the applicant referenced section 1886(d)(5)(K)(ii)(III) of the Act, which refers to an additional payment in an amount that adequately reflects the estimated average cost of such service or technology, and CMS's policy of limiting payment to 50 percent of the cost of the technology, as codified under Sec. 412.88(a)(2)(i) of our regulations. However, the applicant believed that limiting new technology add-on payments for cases involving the BLINCYTOTM technology if the maximum payment amount is based on an expected average number of days of care may inappropriately limit the total payment for the case, which the applicant asserted is inconsistent with the statute. The applicant further stated that if the new technology maximum add-on payment is capped at a level less than 50 percent of the estimated costs of case based on the full 28-day cycle, it may negatively impact access to care for those patients who require a longer inpatient admission. The applicant explained that, in the case of the BLINCYTOTM technology, the cost of the technology is likely to be a significant driver in the overall cost of the admission and it is less likely that other charges unrelated to the use of the BLINCYTOTM technology would be the primary driver for an increased new technology add-on payment amount. The applicant indicated that using a methodology that relies on the average cost of a case that is based on a number of treatment days that is less than the 28-day treatment cycle to establish the maximum add-on payment amount would disadvantage any hospital that treats Medicare beneficiaries who remain admitted to the hospital for longer than the mean total inpatient days per cycle observed in clinical trials. Therefore, the applicant encouraged CMS to set the maximum new technology add-on payment amount based on the full 28-day course of therapy.

    Response: We disagree with the applicant that it would be most appropriate to determine the maximum new technology add-on payment amount for a case based on the recommended estimated 28-day treatment cycle. As the applicant acknowledged, in cases where there are different dosages administered on different days and different device sizes being used, it would be difficult for us to differentiate which charges on claims would trigger the case's eligibility for the new technology add-on payment. It is historical practice for CMS to make the new technology add-on payment based on the average cost of the technology and not the maximum. For example, in the FY 2013 IPPS/LTCH PPS final rule (77 FR 53358), we approved new technology add-on payments for DIFICIDTM based on the average dosage of 6.2 days rather than the maximum 10 day dosage. In addition, as discussed below, based on the clinical trial data, the weighted average of cycle 1 and 2 treatment length is 17 days, as none of the five cycles typically reach 28 days. Just as some cases' length of stay will be above the weighted mean and a hospital's costs may exceed the payment for these cases, other cases' length of stay may be below the weighted mean and hospitals costs would be lower than what the hospital is paid. Therefore, because we are not able to differentiate which charges on claims would trigger the case's eligibility for the new technology add-

    on payment if we based the maximum new technology add-on payment amount for a case on a 28-day treatment cycle, we believe that it is appropriate to use the average cost and the weighted mean of the first two cycles to establish the maximum new technology add-on payment for the BLINCYTOTM technology. However, the applicant is welcome to submit additional data for FY 2017 that demonstrates changes to the weighted mean of the first two cycles.

    In order to establish the maximum new technology add-on payment amount for a case involving the BLINCYTOTM technology for FY 2016, we used the weighted average of the cycle 1 and cycle 2 observed treatment length. Specifically, in the Phase II trial, the most recent data available, 92 patients received cycle 1 for an average length of 21.2 days, and 52 patients received cycle 2 for an average length of 10.2 days. The weighted average of cycle 1 and 2 treatment length is 17 days. We note that a small number of patients also received 3 to 5 treatment cycles. However, based on the data provided, these cases do not appear to be typical at this point and we excluded them from this calculation. We note that, if we include all treatment cycles in this calculation, the weighted average number of days of treatment is much lower, 10 days. Using the clinical data provided by the applicant, we believe that setting the maximum new technology add-on payment amount for a case involving the BLINCYTOTM

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    technology for FY 2016 based on a 17-day length of treatment cycle is representative of historical and current practice. For FY 2107, if new data on length of treatment are available, we would consider any such data in evaluating the maximum new technology add-on payment amount.

    In the application, the applicant estimated that the average Medicare beneficiary would require a dosage of 9mcg/day for the first 7 days under the first treatment cycle, followed by a dosage of 28mcg/day for the duration of the treatment cycle, as well as all days included in subsequent cycles. All vials contain 35mcg at a cost of $3,178.57 per vial. The applicant noted that all vials are single-use. Therefore, we have determined that cases involving the use of the BLINCYTOTM technology would incur an average cost per case of $54,035.69 (1 vial/day x 17 days x $3,178.57/vial). Under 42 CFR 412.88(a)(2), we limit new technology add-on payments to the lesser of 50 percent of the average cost of the technology or 50 percent of the costs in excess of the MS-DRG payment for the case. As a result, the maximum new technology add-on payment amount for a case involving the use of the BLINCYTOTM is $27,017.85 for FY 2016.

  218. DIAMONDBACK 360 Coronary Orbital Atherectomy System

    Cardiovascular Systems, Inc. submitted an application for new technology add-on payments for the DIAMONDBACK 360supreg Coronary Orbital Atherectomy System (OAS) (DIAMONDBACKsupreg Coronary OAS) for FY 2016. The DIAMONDBACKsupreg Coronary OAS is a percutaneous orbital atherectomy system used to facilitate stent delivery in patients who have been diagnosed with coronary artery disease and severely calcified coronary artery lesions. The system uses an electrically driven, diamond-coated crown to reduce calcified lesions in coronary blood vessels. The components of the DIAMONDBACKsupreg Coronary OAS are: (1) The DIAMONBACK 360supreg Coronary Orbital Atherectomy Device (OAD); (2) the VIPERWIRE Advance Coronary Guide Wire; (3) the VIPERSLIDE Lubricant; and (4) the Orbital Atherectomy System Pump. The DIAMONBACK 360supreg OAD is designed to track exclusively over the VIPERWIRE, which, in turn, uses the VIPERSLIDE Lubricant to reduce the friction between the drive shaft of the DIAMONBACK 360supreg OAD and the VIPERWIRE. The Orbital Atherectomy System Pump provides the saline pumping mechanism and power to the DIAMONBACK 360supreg OAD. All DIAMONDBACKsupreg Coronary OAS devices are single use and provide sterile application, except for the pump.

    With respect to the newness criterion, the DIAMONDBACKsupreg Coronary OAS received FDA pre-market approval as a Class III device on October 21, 2013. As stated in section II.G.1.a. of the preamble of the proposed rule and this final rule, effective October 1, 2015 (FY 2016), the ICD-10 coding system will be implemented. In the proposed rule, we indicated that the applicant had applied for a new ICD-10-PCS procedure code for consideration at the March 18-19, 2015 ICD-10-CM/PCS Coordination and Maintenance Committee Meeting. In this final rule, we note that the following new ICD-10-PCS procedure codes have been established to uniquely identify the procedures involving the DIAMONDBACKsupreg Coronary OAS, effective October 1, 2015: X2C1361 (Extirpation of matter from coronary artery, one site using orbital atherectomy technology, percutaneous approach, new technology group 1); X2C1361 (Extirpation of matter from coronary artery, two sites using orbital atherectomy technology, percutaneous approach, new technology group 1); X2C2361 (Extirpation of matter from coronary artery, three sites using orbital atherectomy technology, percutaneous approach, new technology group 1); and X2C3361 (Extirpation of matter from coronary artery, four or more sites using orbital atherectomy technology, percutaneous approach, new technology group 1). More information on this request and our approval can be found on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/ICD-9-CM-C-and-M-Meeting-Materials.html and the FY 2016 New ICD-10-PCS codes can be found at the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD10/2016-ICD-10-PCS-and-GEMs.html.

    According to the applicant, the DIAMONDBACKsupreg Coronary OAS is the only atherectomy device that uses centrifugal force and orbital motion and, therefore, is not represented by the rotational, directional, or laser atherectomy device categories (as exemplified by Boston Scientific's Rotablator system, the SilverHawk/Covidient devices, and the Spectranetics ELCA Coronary Laser, respectively). In addition, the applicant asserted that the DIAMONDBACKsupreg Coronary OAS is the first and only device approved for use in the United States as a treatment for patients who have been diagnosed with severely calcified coronary artery lesions to facilitate stent delivery and optimal deployment. Therefore, the applicant believed that the DIAMONDBACKsupreg Coronary OAS meets the newness criterion.

    In the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24439), we presented our concern that, in addition to patients who have been diagnosed with severely calcified coronary artery lesions, the applicant also indicated that the DIAMONDBACKsupreg Coronary OAS may be used in the treatment of patients who do not have severely calcified coronary artery lesions (for example, patients for whom the degree of calcification may not be severe) and that this technology may be substantially similar to the rotational, directional, and laser atherectomy devices that are already on the U.S. market for the treatment of such patients. In the FY 2010 IPPS/RY 2010 LTCH PPS final rule (74 FR 43813 through 43814), we established criteria for evaluating whether a new technology is substantially similar to an existing technology, specifically: (1) Whether a product uses the same or a similar mechanism of action to achieve a therapeutic outcome; (2) whether a product is assigned to the same or a different MS-DRG; and (3) whether the new use of the technology involves the treatment of the same or similar type of disease and the same or similar patient population. If a technology meets all three of these criteria, it would be considered substantially similar to an existing technology and would not be considered ``new'' for purposes of new technology add-on payments.

    With respect to the first criterion, whether a product uses the same or a similar mechanism of action to achieve a therapeutic outcome, the applicant maintained that the technology uses a differential sanding mechanism of action to remove plaque while potentially minimizing damage to the medial layer of the vessel. According to the applicant, this mechanism of action is the only one among atherectomy devices to use centrifugal force and orbital motion and, therefore, is not represented by the rotational, directional, or laser atherectomy device categories. We stated in the proposed rule that the applicant did not include with its application data to show the effectiveness of the orbital mechanism of the DIAMONDBACKsupreg Coronary OAS compared to the effectiveness of the rotational, directional, and laser mechanisms of similar devices used in treating patients with calcified coronary artery lesions. Therefore, we stated that we could not determine if the device's mechanism of action is unique among atherectomy devices as the applicant claimed.

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    With respect to the second criterion, whether a product is assigned to the same or a different MS-DRG, the applicant determined that coronary atherectomy cases for which the DIAMONDBACKsupreg Coronary OAS technology would be appropriate are assigned to MS-DRG 246 (Percutaneous Cardiovascular Procedure with Drug-Eluting Stent with MCC or 4+ Vessels/Stents); MS-DRG 247 (Percutaneous Cardiovascular Procedure with Drug-Eluting Stent without MCC); MS-DRG 248 (Percutaneous Cardiovascular Procedure with Non-Drug-Eluting Stent with MCC or 4+ Vessels/Stents); MS-DRG 249 (Percutaneous Cardiovascular Procedure with Non-Drug-Eluting Stent without MCC); MS-DRG 250 (Percutaneous Cardiovascular Procedure without Coronary Artery Stent with MCC), and MS-DRG 251 (Percutaneous Cardiovascular Procedure without Coronary Artery Stent without MCC). In the proposed rule, we stated our concern that potential cases involving the DIAMONDBACKsupreg Coronary OAS would be assigned to the same MS-DRGs as other cases that use atherectomy devices currently available on the U.S. market.

    With respect to the third criterion, whether the new use of the technology involves the treatment of the same or similar type of disease and the same or similar patient population, the applicant maintained in its application that the DIAMONDBACKsupreg Coronary OAS is the first and only device approved for use in the United States as a treatment for severely calcified coronary lesions. According to the applicant, advances in current stent technology have allowed most patients with coronary lesions to be treated effectively with relatively favorable long-term outcomes. However, there remain subsets of the patient population that are still challenging to treat, including patients with severe coronary calcification. According to the applicant, the DIAMONDBACKsupreg Coronary OAS is the only atherectomy device currently available to treat this patient population because it is the first and only device approved for use in the United States for severely calcified coronary lesions. However, in the proposed rule, we stated our concern that other devices currently available on the U.S. market may not necessarily be contraindicated for use in treating patients with severe coronary calcification. Specifically, we were not sure if patients with less than severe coronary calcification could be appropriately treated using the DIAMONDBACKsupreg Coronary OAS or other atherectomy devices currently available on the U.S. market in order to determine if the DIAMONDBACKsupreg Coronary OAS treats a different patient population as the applicant claimed.

    We invited public comments on if, and how, the DIAMONDBACKsupreg Coronary OAS meets the newness criterion.

    Comment: In a public comment, the applicant asserted that the DIAMONDBACKsupreg Coronary OAS is not substantially similar to the rotational, laser, or other atherectomy devices currently on the U.S. market. Further, with respect to our concern about the device's mechanism of action, the applicant stated that the lack of data comparing the performance of the DIAMONDBACKsupreg Coronary OAS to other atherectomy devices is primarily a result of the FDA's decision to not allow a controlled trial to be conducted that compared the efficacy and effects of FDA-approved technologies or devices and the efficacy and effects of another treatment that is not FDA-approved. Therefore, the applicant stated, a controlled trial was not conducted because currently there are no other technologies specifically approved for the treatment of severely calcified coronary lesions in the United States.

    The applicant also believed the CMS has set a precedent, in the past, by approving devices for new technology add-on payments that treated conditions that were assigned to the same MS-DRGs as other devices, which were reported using the same ICD-9-CM procedure codes. The applicant noted as an example the recent approval of the Zilversupreg PTX Drug-Eluting Peripheral Stent, a drug-eluting stent used for the treatment of patients diagnosed with superficial femoral arteries, procedures that are assigned to MS-DRGs 252, 253, and 254, all of which contain other drug-eluting stents (78 FR 50583). As a result, the applicant believed that CMS' concern and position in regard to contraindication would have precluded the Zilversupreg PTX technology from being approved for new technology add-on payments because there were other stents available on the U.S. market that also were not contraindicated to treat patients diagnosed with superficial femoral arteries, as well as other devices approved and available to treat patients diagnosed with superficial femoral arteries. The applicant noted that the current application for new technology add-on payments is for use of the DIAMONDBACKsupreg Coronary OAS in the treatment of patients diagnosed with severely calcified lesions, which the applicant believed would be appropriately identified using the new ICD-10 codes it requested. Therefore, the applicant believed that isolating this patient population by using the ICD-10 codes to identify procedures involving the DIAMONDBACKsupreg Coronary OAS also may prevent diffusion of the use of the device into inappropriate patient populations.

    Response: We appreciate the applicant's additional input. However, we remain concerned that the DIAMONDBACKsupreg Coronary OAS is substantially similar to other atherectomy devices that are currently available on the U.S. market. Specifically, we are concerned that the orbital mechanism of action performs the same basic motion and has the same function as the current standard of care, rotational atherectomy devices. Although the applicant stated that FDA did not grant approval to conduct a trial comparing approved versus non-approved technologies, we note that the FDA does not prohibit manufacturers from performing other trials outside of the trials included under its approval process. Moreover, we are concerned that the patient population of cases that may be eligible for treatment using the DIAMONDBACKsupreg Coronary OAS also currently has access to other atherectomy devices and similar technologies that are also used in the treatment of similar conditions. We acknowledge that the Zilversupreg PTX technology was approved for new technology add-on payments and that procedures involving this technology are assigned to MS-DRGs that contain other procedures involving stents. Also, we acknowledge that the Zilversupreg PTX was approved for new technology add-on payments when it had been assigned to the same MS-DRGs as other stents, and that the Zilversupreg PTX potentially could have been used to treat a similar or same patient population as other technologies used in procedures involving stents. However, the Zilversupreg PTX was also the first drug-eluting stent technology at the time we approved the application for new technology add-on payments and, therefore, its new mechanism of action set the basis and precedent for new technology add-on payment approval of similar technologies. Absent this, we would have had the same concerns about contraindication for the Zilversupreg PTX technology as we currently have for the DIAMONDBACKsupreg Coronary OAS. After consideration of the public comments we received, we remain concerned if the DIAMONDBACKsupreg Coronary OAS meets the newness criteria.

    With respect to the cost criterion, the applicant determined that cases representing patients who have been treated with transluminal coronary

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    atherectomy for which the DIAMONDBACKsupreg Coronary OAS technology is appropriate map to MS-DRGs 246 through 251 as noted earlier in this section. The applicant searched the claims data in the FY 2013 MedPAR file for cases assigned to these six MS-DRGs (which contained claims for inpatient hospital discharges from October 1, 2012 to September 30, 2013) and identified 5,443 claims for cases reporting ICD-9-CM procedure code 17.55. The applicant indicated that it further examined the claims data for the cases that also reported ICD-9-CM diagnosis code 414.4, and identified 250 claims for cases with a diagnosis of calcified coronary lesion. The applicant stated that it applied the standard trims used by CMS when selecting cases for IPPS rate calibration. Therefore, it included cases from IPPS hospitals, including hospitals located in Maryland, and excluded cases paid by Medicare Advantage plans, statistical outlier cases, and cases from hospitals that did not submit charges in a sufficiently broad range of revenue centers.

    The applicant reported that it conducted 16 sensitivity analyses based on four areas of uncertainty: whether to include all coronary atherectomy cases in the analysis or only those cases that reported calcified coronary artery lesions; whether to consider a lower value or higher value as the acquisition cost of a typical atherectomy catheter; whether to use the full cost of the DIAMONDBACKsupreg Coronary OAS catheter and materials or only the cost of the catheter alone; and whether to include or exclude a factor to inflate costs to FY 2015 costs. Based on the result of the sensitivity analyses with all 16 combinations of the values that the applicant performed, the applicant reported that it determined that the average case-weighted standardized charge per case for the DIAMONDBACKsupreg Coronary OAS would exceed the average case-weighted threshold amounts for MS-DRGs 246 through 251 in Table 10 of the FY 2015 IPPS/LTCH PPS final rule. According to the applicant, the average case-weighted standardized charge per case using the DIAMONDBACKsupreg Coronary OAS device exceeds the average case-

    weighted threshold amounts for MS-DRGs 246 through 251 in Table 10 by approximately $6,000 to $15,000, depending on the results determined by using the combination of values of the four areas of uncertainty. As described below, the applicant believed that using the scenario that produced the lowest difference between the average case-weighted standardized charge per case determined by the applicant's analyses and the average case-weighted threshold amounts for MS-DRGs 246 through 251 from Table 10 in the FY 2015 IPPS/LTCH PPS final rule still exceeded the Table 10 threshold amounts by $5,803.

    Using the scenario that produced the lowest difference between the average case-weighted standardized charge per case determined by the applicant and the average case-weighted threshold amount in the FY 2015 IPPS/LTCH PPS final rule Table 10, the applicant included all cases reporting coronary atherectomy (specifically, the 5,443 cases reported with ICD-9-CM procedure code 17.55) in this analysis. The applicant removed the costs of the other specific technologies used during these procedures; that is, the applicant removed the higher of the two standard catheter costs, and added the full cost of the DIAMONDBACKsupreg Coronary OAS catheter alone. To estimate the cost for the new technology, the applicant divided the projected cost per patient by the national average CCR for supplies (0.292) included in the FY 2015 IPPS/LTCH PPS final rule. This resulted in an average case-

    weighted average standardized charge per case of $86,080. The applicant stated that it did not apply an inflation factor to convert the FY 2013 costs to FY 2015 costs for this analysis. However, in other analyses, the applicant used the 2-year inflation factor of 10.44 percent taken from the FY 2015 IPPS/LTCH PPS final rule (79 FR 50379), which was the final inflation factor used in the CMS outlier threshold calculation for the applicable fiscal year. The applicant then determined that its average case-weighted standardized charge per case exceeded the average case-weighted threshold amounts for MS-DRGs 246 through 251 in Table 10 of the FY 2015 IPPS/LTCH PPS final rule by $5,803. The applicant maintained that all of the results of the analyses using this methodology that were included in its application likewise exceeded the Table 10 threshold amounts for these MS-DRGs and, therefore, demonstrated that the DIAMONDBACKsupreg Coronary OAS meets the cost criterion.

    Using the scenario that produced the lowest difference between its average case-weighted standardized charge per case and the average case-weighted threshold amounts for MS-DRGs 246 through 251 from the FY 2015 Table 10 for the analysis of the subgroup of cases representing patients who have severely calcified coronary artery lesions, the applicant reported that it included all of the cases that report coronary atherectomy that also reported diagnosis of calcified coronary lesions (250 cases reporting ICD-9-CM procedure code 414.4). As in the previous scenario, the applicant removed costs of the other specific technologies used during these other procedures; that is, the applicant removed the higher of the two standard catheter costs, and added the full cost of the DIAMONDBACKsupreg Coronary OAS catheter alone. To estimate the costs for the new technology, the applicant divided the projected cost per patient by the national average CCR for supplies (0.292) in the FY 2015 IPPS/LTCH PPS final rule. This resulted in an average case-weighted standardized charge per case of $86,779. The applicant did not apply an inflation factor to convert the FY 2013 costs to FY 2015 costs for this analysis. The applicant then determined that the average case-weighted standardized charge per case exceeded the FY 2015 Table 10 threshold amount of $80,807 by $5,972. The applicant maintained that all of the results of the analyses using this methodology that were included in its application likewise exceeded the Table 10 threshold amounts for these MS-DRGs and, therefore, demonstrated that the DIAMONDBACKsupreg Coronary OAS meets the cost criterion.

    In the proposed rule, we questioned some of the assumptions underlying the four areas of uncertainty that were the basis for the applicant's sensitivity analyses. We stated that we would like to know the basis of the higher value that the applicant considered to be a possible acquisition cost of a typical atherectomy catheter. We also stated our concern that the applicant did not provide a basis for determining the two values it used to remove the costs associated with the other specific technologies that may have been used during the cases included in the analysis. We invited public comments on if, and how, the DIAMONDBACKsupreg Coronary OAS meets the cost criterion.

    Comment: The applicant (the manufacturer) addressed CMS' concerns that were presented in the proposed rule by conducting another cost analysis. The applicant reported that it determined the cost of the existing technology by utilizing data from the Millennium Research Group, which publishes an annual report in the coronary market. The applicant referenced the average sales price in 2015 for rotational atherectomy, which is the standard device currently used in coronary atherectomy procedures. The applicant stated that the additional analysis included the cost for associated supplies and the average sales price of the rotational atherectomy catheter. The applicant maintained that, in both cost

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    analyses, the DIAMONDBACKsupreg Coronary OAS exceeded the cost threshold and, therefore, meets the cost criterion.

    Response: We appreciate the applicant's response and subsequent analyses, which we believe respond to the concerns we raised in the proposed rule.

    After consideration of the applicant's response, we have determined that the DIAMONDBACKsupreg Coronary OAS meets the cost criterion.

    As discussed in the proposed rule, in regard to substantial clinical improvement, the applicant maintained that the DIAMONDBACKsupreg Coronary OAS offers a treatment option for a patient population that has been diagnosed with severely calcified coronary arteries that are ineligible for currently available treatments and results in improved clinical outcomes for patients who have been diagnosed with complex coronary artery disease related to severely calcified coronary arteries. The applicant also stated that the DIAMONDBACKsupreg Coronary OAS device significantly improves clinical outcomes for this patient population when compared to currently available treatment options, including reduced mortality, a reduced rate of device-related complications, a decreased rate of subsequent diagnostic or therapeutic interventions (for example, due to reduced rate of recurrence of the disease process), a decreased number of future hospitalizations or physician visits, more rapid beneficial resolution of the disease process treatment because of the use of the device, decreased pain, bleeding, or other quantifiable symptoms, and reduced recovery time.

    The applicant included data from its ORBIT II study to demonstrate that the technology represents substantial clinical improvement over currently available treatment options, including improvement in mortality rates, major adverse cardiac event (MACE) rates, revascularization rates, and cost savings. According to the applicant, its ORBIT II study was a pivotal clinical study to evaluate the safety and effectiveness of the DIAMONDBACKsupreg Coronary OAS in treating a subset of patients who have severely calcified coronary artery lesions. The applicant explained that the ORBIT II study was a prospective, multicenter, non-blinded clinical trial that enrolled 443 consecutive patients who have been diagnosed with severely calcified coronary lesions at 49 U.S. sites from May 25, 2010 to November 26, 2012, in which the DIAMONDBACKsupreg Coronary OAS was used to prepare patients who had severely calcified coronary lesions for stent placement. According to the applicant, the DIAMONDBACKsupreg Coronary OAS produced clinical outcomes that exceeded its ORBIT II study's two primary safety and efficacy endpoints within a patient population. The primary safety endpoint was 89.6 percent freedom from 30-day MACE, compared with the performance goal of 83 percent. The primary efficacy endpoint (residual stenosis 9 10 11 The applicant maintained that, compared to these historical study data, the data results of the ORBIT II study demonstrated much lower cardiac death rates of 0.2 percent in-hospital and 0.2 percent at 30 days. The applicant further reported that the results of its ORBIT II study showed lower mortality rates at 9 months and 1 year (3 percent and 4.4 percent, respectively) compared to previously reported rates (5.0 percent and 5.85 percent at 9 months and 6.3 percent at 1 year). The study report by Mosseri, et al. also reported a 1.6 percent in-hospital target lesion revascularization rate (TLR) in a patient population with more superficial calcification,\12\ whereas the study report by Clavijo, et al. reported a 1.3 percent 30-day TLR rate for the RA + DES group.\13\ In contrast, the applicant reported that the results of the ORBIT II study showed a lower TLR rate of 0.7 percent (both in-hospital and 30-

    day), even though more patients who had severely calcified coronary lesions were included in the study, and the patients were older and had more comorbidities. The applicant stated that, at 1-year, the results of the ORBIT II study showed a higher freedom from TVR/TLR rate (94.1 percent) compared to previously reported rates (81.7 percent to 91.3 percent), even though patients who had more severely calcified coronary lesions were included in the ORBIT II study. According to the applicant, the MACE rate of 16.4 percent indicated in the results of the ORBIT II study was lower than the rate of the ROTAXUS (24.4 percent) and ACUITY/HORIZONS (19.9 percent) trials despite the use of a less stringent standard of severe calcification in the latter studies.14 15 Further, the

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    applicant reported that patients in the ORBIT II study experienced a lower rate of device-related complications (such as dissection, abrupt closure, and perforation) compared to rates in the historical studies. Overall, the applicant asserted that a comparison of data from the ORBIT II study and the data from historical studies demonstrates that patients in the ORBIT II study had more severe calcium coronary lesions and potentially were more difficult to treat, although they experienced better outcomes.

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    \9\ Mosseri M, Satler LF, Pichard AD, Waksman R. Impact of vessel calcification on outcomes after coronary stenting. Cardiovasc Revascularization Med Mol Interv. 2005;6(4):147-153.

    \10\ Abdel-Wahab M, Richardt G, Joachim Buttner H, et al. High-

    speed rotational atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions: The randomized ROTAXUS (Rotational Atherectomy Prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease) trial. JACC Cardiovasc Interv. 2013;6(1):10-19.

    \11\ Clavijo LC, Steinberg DH, Torguson R, et al. Sirolimus-

    eluting stents and calcified coronary lesions: clinical outcomes of patients treated with and without rotational atherectomy. Catheter Cardiovasc Interv Off J Soc Card Angiogr Interv. 2006;68(6):873-878.

    \12\ Mosseri M, Satler LF, Pichard AD, Waksman R. Impact of vessel calcification on outcomes after coronary stenting. Cardiovasc Revascularization Med Mol Interv. 2005;6(4):147-153.

    \13\ Clavijo LC, Steinberg DH, Torguson R, et al. Sirolimus-

    eluting stents and calcified coronary lesions: clinical outcomes of patients treated with and without rotational atherectomy. Catheter Cardiovasc Interv Off J Soc Card Angiogr Interv. 2006;68(6):873-878.

    \14\ Genereux P, Madhavan MV, Mintz GS, et al. Ischemic outcomes after coronary intervention of calcified vessels in acute coronary syndromes. Pooled analysis from the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) TRIALS. J Am Coll Cardiol. 2014;63(18):1845-1854.

    \15\ Abdel-Wahab M, Richardt G, Joachim Buttner H, et al. High-

    speed rotational atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions: The randomized ROTAXUS (Rotational Atherectomy Prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease) trial. JACC Cardiovasc Interv. 2013;6(1):10-19.

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    In the proposed rule, we stated our concern that the ORBIT II study conducted by the applicant lacked a control arm. The applicant asserted in its original application that, although other FDA-approved coronary atherectomy products are available, none of them are indicated for the treatment of patients who have severely calcified coronary arteries and, therefore, could not be used as a control. The applicant believed that it accounted for this study limitation by comparing the results of the ORBIT II study to historical control subjects documented in published reports. However, we stated that we continue to be concerned that meaningful conclusions cannot be drawn from a study that did not include a comparator group. Moreover, we questioned the reliability of comparing data from the ORBIT II study to historical study data because different definitions of severe calcification used in each study can make absolute comparisons difficult and/or invalid.

    We invited public comments on if, and how, DIAMONDBACKsupreg Coronary OAS meets the substantial clinical improvement criterion.

    Comment: Several commenters believed that the DIAMONDBACKsupreg Coronary OAS meets the substantial clinical improvement criterion and, therefore, recommended that CMS approve the application for new technology add-on payments for FY 2016. In particular, the applicant stated in its public comment that the single-arm ORBIT II trial and historical comparator data are sufficient to demonstrate substantial clinical improvement because the results show that the DIAMONDBACKsupreg Coronary OAS performed better than other atherectomy devices on key safety and efficacy endpoints despite a more rigorous definition of severe calcification in the ORBIT II trial. The applicant also emphasized that the ORBIT II trial is one of the few FDA-approved single-arm coronary PCI trials in the last two decades, and that the lack of a comparator group does not negate the logic and scientific validity of the trial. Other commenters believed that there is adequate clinical and economic evidence to justify an approval of new technology add-on payments for the DIAMONDBACKsupreg Coronary OAS due to the high-risk and resource intensive treatment that is typical for a patient diagnosed with severely calcified coronary lesions.

    Response: We appreciate the commenters' input. However, we do not believe the safety and efficacy endpoints used in the ORBIT II trial represent a substantial clinical improvement over existing atherectomy devices available and accessible to the Medicare population. While we recognize that the DIAMONDBACKsupreg Coronary OAS has met the FDA's standards for safety and effectiveness, the new technology add-on payment policy requires that the technology demonstrate a substantial clinical improvement, which is not inherent in FDA's regulatory process. Moreover, while we agree with the commenters that patients with severely calcified coronary lesions require more resource intensive treatment and are at higher risk of responding poorly to currently available treatments, we also are not convinced that this patient population is not currently being treated with the use of a rotational, directional, or laser atherectomy device that achieves the same or similar therapeutic outcomes as the DIAMONDBACKsupreg Coronary OAS. Because the applicant did not include data to compare the performance of currently available atherectomy devices used in treating patients diagnosed with severely calcified coronary lesions, we remain unable to make a determination as to whether use of the DIAMONDBACKsupreg Coronary OAS results in a substantial clinical improvement over existing and currently available treatment options for the Medicare population.

    After consideration of the public comments we received, we have determined that the DIAMONDBACKsupreg Coronary OAS does not meet the criteria for approval of a new technology add-on payment. We remain concerned as to whether the DIAMONDBACKsupreg Coronary OAS meets the newness criteria. Furthermore, we do not believe that the device represents a substantial clinical improvement over existing and currently available treatment options. Therefore, we are not approving new technology add-on payments for this technology for FY 2016.

  219. CRESEMBAsupreg (Isavuconazonium)

    Astellas Pharma US, Inc. (Astellas) submitted an application for new technology add-on payments for CRESEMBAsupreg (isavuconazonium) for FY 2016. CRESEMBAsupreg is an intravenous and oral broad-spectrum antifungal used for the treatment of adults who have severe invasive and life-threatening fungal infections, including invasive aspergillosis and mucormycosis (zygomycosis).

    CRESEMBAsupreg received FDA approval on March 6, 2015. The FDA indication for the use of this product is for the treatment of adults who have been diagnosed with invasive aspergillosis and mucormycosis. Isavuconazonium has two formulations: an intravenous (IV) solution and an oral capsule. The IV formulation of CRESEMBAsupreg is administered at 200 mg while the oral formulation is administered at 100 mg. Dosing is not weight-based. According to the applicant, treatment of patients who have been diagnosed with these types of infection starts with up to 3 days of IV therapy in the inpatient hospital setting followed by daily oral therapy administered for the remainder of the inpatient stay and also the duration of treatment period, which is approximately 13.4 days.

    As stated in section II.G.1.a. of the preamble of the proposed rule and this final rule, effective October 1, 2015 (FY 2016), the ICD-10 coding system will be implemented. In the proposed rule, we noted that the applicant had applied for a new ICD-10-PCS procedure code for consideration at the March 18-19, 2015 ICD10-CM/PCS Coordination and Maintenance Committee Meeting. In this final rule, we note that the following two new ICD-10-PCS procedure codes have been established to uniquely identify procedures involving CRESEMBAsupreg: XW03341 (Introduction of isavuconazole anti-infective into peripheral vein, percutaneous approach, new technology group 1); and XW04331 (Introduction of isavuconazole anti-infective into central vein, percutaneous approach, new technology group 1). More information on this request and the approval can be found on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD10/2016-ICD-10-PCS-and-GEMs.html.

    The applicant maintained that CRESEMBAsupreg meets the newness criterion based on the March 6, 2015 FDA approval of the technology.

    CRESEMBAsupreg is part of the category of drugs known as azole antifungal drugs that inhibit the enzyme lanosterol 14 alpha-

    demethylase. Inhibiting this enzyme disrupts the process of converting lanosterol to ergosterol and, therefore, depletes the level of ergosterol in the fungal membrane and inhibits fungal growth. Azole antifungal drugs are used to treat patients with fungal infections such as aspergillosis, and other azole

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    antifungal drugs also used for the treatment of these patients include voriconazole, posaconazole, and itroconazole. The CDC Web site at http://www.cdc.gov/fungal/diseases/aspergillosis/treatment.html states that voriconazole is used for the treatment of patients with invasive aspergillosis, but amphotericin B (Amp B) as well as other antifungal drugs can be used if patients cannot take voriconazole or the infection is not responsive to voriconazole. Amphotericin B is the firsthyphenline of therapy and the only FDAhyphenapproved treatment of patients diagnosed with mucormycosis. Amphotericin B binds with ergosterol, a component of fungal cell membranes, and forms a transmembrane channel that leads to membrane leakage, which is the primary effect leading to fungal cell death. The third class of antifungal drugs is echinocandins; examples in this group are caspofungin, micafungin, and anidulafungin. Echinocandins noncompetitively inhibit beta-1, 3-D-glucan synthase enzyme complex in susceptible fungi to disturb fungal cell glucan synthesis. Beta-glucan destruction prevents resistance against osmotic forces, which leads to cell lysis (http://www.cdc.gov).

    According to the applicant, echinocandins are effective against aspergillosis. Voriconazole is the recommended treatment for patients diagnosed with invasive aspergillosis. However, amphotericin B and other antifungal drugs may also be used if voriconazole cannot be administered because a patient is suffering from porphyria (a rare inherited blood disorder) or has had an allergic reaction to the drug or the infection is not responding to treatment using voriconazole. In addition, according to the applicant, the efficacy of azole antifungal drugs, such as posaconazole, in treating mucurmycosis is uncertain but has been described in certain situations.

    The applicant stated that it is challenging to clinically distinguish the type of antifungal infection a patient may be experiencing. Therefore, the typical treatment of patients exhibiting symptoms of an invasive fungal infection includes both amphotericin B and voriconazole. According to the applicant, for the Medicare population, both drugs are usually administered in combination because it is difficult and time-consuming to delineate the specific type of fungal infections. The applicant noted that these patients are often severely ill and immediate treatment of these symptoms is essential to the effective management of their condition.

    In the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24442), we stated we were concerned that CRESEMBAsupreg may not meet the newness criterion because it may be substantially similar to other currently approved antifungal drugs. We refer readers to the FY 2010 LTCH PPS final rule (74 FR 43813 through 43814) for a discussion of our established criteria for evaluating whether a new technology is substantial similar to an existing technology, specifically: (1) Whether a product uses the same or a similar mechanism of action to achieve a therapeutic outcome; (2) whether a product is assigned to the same or a different MS-DRG; and (3) whether the new use of the technology involves the treatment of the same or similar type of disease and the same or similar patient population. If a technology meets all three of these criteria, it would be considered substantially similar to an existing technology and would not be considered ``new'' for purposes of new technology add-on payments.

    In evaluating this technology for substantial similarity, in the proposed rule, we stated that we believe that CRESEMBAsupreg has a similar mechanism of action as the other groups of antifungal drugs available for the treatment of patients diagnosed with serious fungal infections, such as invasive aspergillosis and mucormycosis. As previously noted, voraconazole and itroconazole also are commonly used azole antifungals used to treat patients diagnosed with aspergillosis. The applicant maintained that the availability of the drug in an oral formulation constitutes a different mechanism of action from the current azoles. In the proposed rule, we stated that we disagreed with the applicant's assertion because we believe a different method of administration does not necessarily equate to a different mechanism of action. Although the applicant maintained that this technology is not substantially similar because it is administered orally, the applicant did not describe why it believed a different method of administration constitutes a different mechanism of action. Because CRESEMBAsupreg is part of the category of drugs currently available known as azole antifungal drugs that inhibit the enzyme lanosterol 14 alpha-

    demethylase, it appears that the mechanism of action is not different, but that merely the method of administration differs.

    With respect to the second criterion for determining substantial similarity, we stated in the proposed rule that we believe that the use of CRESEMBAsupreg is inclusive of the current treatment options available to Medicare beneficiaries and is also currently described (although not specifically) by established procedure codes that identify similar technologies, specifically other antifungal drugs that also are used in the treatment of patients diagnosed with similar fungal infections. The use of antifungal drugs is considered a nonoperating room procedure, which does not impact the MS-DRG assignment of a patient case. Therefore, the use of CRESEMBAsupreg would not impact the MS-DRG assignment of a particular case. Furthermore, the FDA approval for the technology is indicated for use in the treatment of the same or similar type of disease and the same or similar patient population. According to the applicant, CRESEMBAsupreg is used in conjugation with other treatments, and this is reflected in its analysis for the new technology cost criterion. In the proposed rule, we stated our concern that this technology is administered with the other currently available treatments and, therefore, cannot be considered an alternative treatment option. Therefore, we stated that we believe that CRESEMBAsupreg may be considered substantially similar to other available treatments and could not be considered to be ``new'' for purposes of new technology add-on payments.

    We invited public comments on if, and how, CRESEMBAsupreg meets the newness criterion and our concerns regarding how it is similar to other treatments for serious fungal infections.

    Comment: One commenter (the applicant and manufacturer of CRESEMBAsupreg) submitted comments to further support its assertion and address our concerns that CRESEMBAsupreg meets the newness criterion. The applicant stated that although the active moiety contained in CRESEMBAsupreg has a similar mechanism of action as the other groups of antifungal drugs available for the treatment of patients diagnosed with serious fungal infections, such as invasive aspergillosis and mucuromycosis, CRESEMBAsupreg contains a water soluble prodrug specifically developed to facilitate the systemic delivery of the active moiety. The applicant pointed out that the technology allows intravenous administration without the need for nephrotoxic excipients, such as cyclodextrins, that are present in other antifungals, which are restricted from use in the treatment of patients diagnosed with renal impairment.\16\ The applicant further noted that CRESEMBAsupreg administered

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    intravenously can be used in patients diagnosed with renal impairment, and dose adjustments are not necessary or recommended for the treatment of elderly patients or patients diagnosed with renal impairments.

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    \16\ Ader et al, 2009; Girmenia, 2009.

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    The applicant further stated that other existing treatments for invasive mold infections have limitations due either to the potential for toxicity, or restrictions on its use in the treatment of certain at-risk patient populations. The commenter noted that, although the liposomal preparation of amphotericin B has reduced the potential for nephrotoxicity, it does not eliminate it completely. According to the applicant, amphotericin B is nephrotoxic when administered with calcineurin inhibitors and also requires intravenous administration, which may complicate long-term administration. The applicant reiterated that cyclodextrins used in the intravenous preparation of posaconazole, itraconazole and voriconazole exhibit additional nephrotoxicity and, therefore, its uses in the treatment of patients diagnosed with renal impairment are restricted.\17\ Therefore, the applicant believed that there is an urgent need for potent and safe antifungal agents that can be administered both orally and intravenously without increased potential for nephrotoxicity.

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    \17\ Ibid.

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    The applicant also clarified that CRESEMBAsupreg does not need to be administered in conjugation with other currently available treatments. The applicant stated that the results of its phase III studies demonstrated the efficacy of the CRESEMBAsupreg technology as a singular treatment for invasive mold infections. In addition, the applicant stated that it recognized that CRESEMBAsupreg has some attributes that are similar to other azoles antifungals. However, it believed that CRESEMBAsupreg offers a needed alternative therapy for the treatment of patients diagnosed with invasive aspergillosis (IA) and mucuromycosis (IM), given that currently approved therapies for the treatment of IA and IM are limited by: (1) Pharmacokinetic challenges and toxicity, as noted with voriconazole; and (2) subhyphenoptimal efficacy in highhyphenrisk patients, as noted with amphotericin B. The applicant stated that these two characteristics make these therapies often unusable in the treatment of patients most likely to later suffer from a diagnosis of IA and IM (for example, immunocompromised patients), and mortality rates remain high for both diseases. The applicant further stated that patients diagnosed with progressive IA or who are intolerant of voriconazole have few viable options, and there are currently no other approved primary treatments for patients diagnosed with IM except amphotericin B. The applicant believed that CRESEMBAsupreg is an alternative treatment option because patients who cannot tolerate other existing therapies can be treated with CRESEMBAsupreg; otherwise, no other treatment option would be available.

    The applicant asserted that data from studies of both the oral and IV formulations have shown that CRESEMBAsupreg has a more predictable pharmacokinetic/pharmacodynamic profile compared to voriconazole. The applicant further indicated that CRESEMBAsupreg has moderate pharmacokinetic variability, which limits the risk of subhyphentherapeutic or suprahyphentherapeutic exposure, while the variability of voriconazole pharmacokinetics is high. According to the applicant, the pharmacokinetics of CRESEMBAsupreg include: Linear and dosehyphenproportional effects following both oral and IV administration; a long halfhyphenlife enabling once daily maintenance dosing; oral bioavailability of 98 percent; the absence of food orgastric pH effects; and the option to be administered via both routes of administration under fed or fasting conditions irrespective of the use of drugs that increase gastric pH. Therefore, the applicant believed that a more manageable drughyphendrug interaction profile was observed with respect to the CRESEMBAsupreg technology compared to other moldhyphenactive azoles antifungals.

    Response: We appreciate the applicant's additional input and information in support of the application. We recognize that the CRESEMBAsupreg prodrug was specifically developed to facilitate the systemic delivery of the active moiety and reduces the risk of nephrotoxicity relative to other azole antifungals. However, despite the lack of presence of nephrotoxic cyclodextrins, we continue to believe that the CRESEMBAsupreg uses the same mechanism of action as other azole antifungals because they both inhibit the enzyme lanosterol 14 a-demethylase.

    In addition, we continue to believe that the CRESEMBAsupreg technology is substantially similar to the current treatment options available to Medicare beneficiaries that are also currently described (although not specifically) by established procedure codes that identify the use of these similar technologies, specifically other antifungal drugs that also are used in the treatment of patients diagnosed with similar fungal infections. As the applicant stated, while the use of amphotericin B may not be an ideal treatment option for some patients because it has many adverse side effects, we disagree with the applicant that CRESEMBAsupreg offers an alternative treatment option instead of amphotericin B for patients who cannot tolerate other existing therapies and would otherwise have no other treatment option because amphotericin B and other antifungal drugs can also be effective and used as an option to treat patients diagnosed with IM. Therefore, we believe that, although CRESEMBAsupreg can be effectively administered without other antifungal drugs, the technology would be used to treat the same or similar type of disease and the same or similar patient population as other antifungal drugs.

    After consideration of the public comment we received, we believe that the CRESEMBAsupreg technology is substantially similar to other azole antifungal drugs because it meets all three of the criteria identified above and, therefore, does not meet the newness criterion.

    As we discussed in the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24442 and 24443), to demonstrate that the technology meets the cost criterion, the applicant performed two analyses. The applicant searched claims in the FY 2013 MedPAR file (across all MS-DRGs) for any case reporting a principal or secondary diagnosis of aspergillosis (ICD-9-CM diagnosis code 117.3), zygomycosis phycomycosis or mucormycosis (ICD-

    9-CM diagnosis code 117.7), or pneumonia in aspergillosis (ICD-9-CM diagnosis code 484.6). The applicant excluded any case that was treated at a hospital that is not paid under the IPPS, as well as any case where Medicare fee-for-service was not the primary payer. The applicant calculated the standardized charge for each eligible case and then inflated the standardized charge by 10.4427 percent using the same inflation factor used by CMS to update the FY 2015 outlier threshold (79 FR 50379). The applicant assumed that the average length of stay for all eligible cases was 13.4 days based on its analysis. To determine the charges for the drug, the applicant assumed 13.4 days of therapy. According to the applicant, dosages of isavuconazole for a patient vary based on the day of therapy, but do not vary based on the patient's weight. For the first and second day of therapy, the patient would be administered a loading dose of 200 milligrams (mg) every 8 hours. For each subsequent day of therapy, the patient would be

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    administered a maintenance dose of 200 mg per day.

    For the first analysis, which was based on 100 percent of all MS-

    DRGs, the applicant identified a total of 5,984 cases with at least one of the three ICD-9-CM codes (aspergillosis (ICD-9-CM diagnosis code 117.3), zygomycosis phycomycosis or mucormycosis (ICD-9-CM diagnosis code 117.7), or pneumonia in aspergillosis (ICD-9-CM diagnosis code 484.6)) across a total of 333 MS-DRGs. The applicant's rationale for using all the MS-DRGs was that it believed any patient diagnosed with either invasive aspergillosis or invasive mucormycosis (zygomycosis) could be eligible for treatment using isavuconazonium, regardless of the MS-DRG assignment. The applicant identified the average case-

    weighted threshold amounts for these 333 MS-DRGs as $72,186 using Table 10 from the FY 2015 IPPS/LTCH PPS final rule. The applicant did not remove charges for the other specific technologies from the average case-weighted standardized charge per case. The applicant's rationale for not removing these charges was that the patients would be administrated isavuconazonium in combination with the other currently approved antifungal drugs as an effective treatment plan. The applicant computed a final inflated average case-weighted standardized charge per case of $151,450. Because this average case-weighted standardized charge per case exceeded the average case-weighted threshold amount from the FY 2015 Table 10, the applicant maintained that CRESEMBAsupreg meets the cost criterion using this first analysis.

    For its second analysis, the applicant analyzed 39 MS-DRGs that accounted for the top 75 cases of patients eligible for treatment using isavuconazonium; this was a subset of 4,510 cases. Using a methodology similar to the one used in its first analysis, the applicant computed the final inflated average case-weighted standardized charge per case of $159,622. The applicant identified an average case-weighted threshold amount for the 39 MS-DRGs of $74,366 using Table 10 from the FY2015 IPPS/LTCH PPS final rule. Because the final inflated average case-weighted standardized charge per case exceeded the average case-

    weighted threshold amount in the FY 2015 Table 10, the applicant maintained that CRESEMBAsupreg meets the cost criterion using this second analysis.

    In the proposed rule, we stated we were concerned that the applicant did not remove any charges for the other antifungal drugs used during treatments (that is, the other component of the combination) because the applicant maintained that it would most likely be necessary for patients who are treated using CRESEMBAsupreg to also continue treatment using the other antifungal drugs or medications in order to achieve successful treatment due to the severity of their symptoms. We believe that the applicant should have removed the charges for the other antifungal drugs used for treatments. We also noted that the applicant did not provide information to substantiate its assertion that the charges for these cases would not be reduced because of the severity of illness among the patients. The applicant inferred that patients treated using CRESEMBAsupreg would be dependent upon the simultaneous and combined use of the other existing therapies to achieve successful treatment. Therefore, we stated our concern about the possibility of drug toxicity, poly pharmacy, and drug-to-drug interactions, especially among the Medicare population.

    We invited public comment on whether CRESEMBAsupreg meets the cost criterion, specifically with regard to our concerns regarding the applicant's analyses and methodology.

    Comment: To address CMS' concerns stated in the proposed rule, the applicant submitted additional information that included the results from conducted sensitivity analyses to determine whether the cost of the cases included in its cost analysis presented in the proposed rule would have continued to exceed the cost threshold for the respective MS-DRGs after removing the submitted charges for other drugs. Using a methodology similar to the methodology used in the previous cost analyses as presented in the proposed rule, the applicant conducted three subsequent analyses that removed 18.3 percent, 41.0 percent, and 100 percent of charges associated with other drugs. The applicant reported that the average case-weighted threshold amount for the respective MS-DRGs remained at $72,186. Under each analysis, the average case-weighted standardized charges per cases were $145,260, $137,641, and $117,838 respectively. Because the average case-weighted standardized charge per case for each scenario exceeded the average case-weighted threshold amount for the respective MS-DRGs ($72,186), the applicant maintained that the CRESEMBAsupreg meets the cost criterion based on the results of its new analysis.

    Response: We appreciate the applicant's additional input and information. After consideration of the subsequent analysis presented by the applicant and its results, we believe that the CRESEMBAsupreg meets the cost criterion.

    As we discussed in the proposed rule, with regard to substantial clinical improvement, the applicant stated that CRESEMBAsupreg represents a substantial clinical improvement over existing therapies for patients diagnosed with invasive aspergillosis and mucormycosis based on its potentially improved efficacy profile, potentially improved safety profile, more favorable pharmacokinetic profile, and improved method of administration. The applicant discussed the unmet medical need for alternative treatment options for patients diagnosed with invasive aspergillosis and mucormycosis. Current treatments have limitations related to safety, side effects, and efficacy.18 19 The applicant provided information regarding its SECURE study, where the primary endpoint of all-cause mortality through day 42 showed that CRESEMBAsupreg demonstrated noninferiority to voriconazole. The primary endpoint of allhyphencause mortality through day 42 in the intenthyphentohyphentreat population (ITT, N=516) was 18.6 percent in the isavuconazonium treatment group and 20.2 percent in the voriconazole group. However, according to the applicant, the overall safety profile for CRESEMBAsupreg demonstrated similar rates of mortality and nonfatal adverse events as the comparator, voriconazole. The applicant also shared information from other clinical trials. One of these clinical trials that studied the treatment of patients diagnosed with invasive aspergillosis showed treatment-

    emergent adverse reactions occurred in 96 percent and 99 percent of patients receiving the CRESEMBAsupreg and voriconazole. In the proposed rule, we stated that the adverse reactions associated with the use of CRESEMBAsupreg and voriconazole appear to be similar.

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    \18\ Lin SJ, Schranz J, Teutsch SM.: Aspergillosis casehyphenfatality rate: systematic review of the literature. ClinInfect Dis. 2001;32:358hyphen66.

    \19\ Greenberg RN, Scott LJ, Vaughn HH, Ribes JA.: Zygomycosis (mucormycosis): emerging clinical importance and new treatments. Curr Opin Infect Dis. 2004;17:517-25.

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    Comment: In response to our concerns, the applicant noted that patients being treated with CRESEMBAsupreg had a reduced number of treatment-related discontinuations over existing therapies. The applicant stated that the treatmenthyphenemergent adverse events (TEAEs) were reported in 96.1 percent of patients who received treatment using the CRESEMBAsupreg technology and 98.5 percent of patients who received treatment using voriconazole. The applicant further stated that the five most common events

    Page 49459

    that occurred in >=5 percent of the patients in either group were nausea, vomiting, diarrhea, pyrexia, and hypokalemia, and the most frequent adverse events by system organ class were gastrointestinal disorders (67.7 percent for patients treated using CRESEMBA,supreg 69.5 percent for patients treated using voriconazole), and infections/

    infestations (59.1 percent for patients treated using CRESEMBA,supreg 61.0 percent for patients treated using voriconazole). The applicant also noted that the results indicated the following TEAEs were significantly less common with the group of patients treated using CRESEMBAsupreg compared to the group of patients treated using voriconazole: Skin and subcutaneous tissue disorders (33.5 percent for the group of patients treated with CRESEMBA,supreg 42.5 percent for the group of patients treated using voriconazole; p = 0.037), eye disorders (15.2 percent for the group of patients treated using CRESEMBA,supreg 26.6 percent for the group of the patients treated using voriconazole; p = 0.002), and hepatobiliary disorders (CRESEMBAsupreg 8.9 percent, voriconazole 16.2 percent; p = 0.016). The applicant believed that the differences between the efficacy and effectiveness of the CRESEMBAsupreg compared to voriconazole as a result of the overall analysis of TEAEs and serious TEAEs were consistent with those of the subgroup analysis by age categories, gender, race, ethnicity, geographical region, receipt of allogeneic transplantation, active malignancy status, and neutropenia at baseline. The applicant stated that no clinically relevant trends were observed with other safety parameters, including laboratory parameters and ECG during the 84hyphenday treatment period.

    Response: We appreciate the additional information presented by the applicant in response to our concerns. While we recognize that CRESEMBAsupreg meets FDA standards for safety and effectiveness, demonstration of a substantial clinical improvement over existing technologies available to Medicare beneficiaries is not necessarily inherent in the FDA's regulatory requirement for the technology. We believe that the data presented by the applicant to support a substantial clinical improvement based on the demonstration of reduced TEAEs did not show results demonstrating significant differences regarding the analysis' comparables. While we acknowledge that, in the setting of similar overall safety profiles, the discontinuation rates are reduced with the use of the CRESEMBAsupreg technology when compared to use of voriconzole, we are unsure if the noted differences in the overall safety profiles demonstrate statistical significance.

    In the proposed rule, we also stated that we were concerned that the applicant did not conduct the clinical trials evaluating head-to-

    head comparisons to alternative therapies such as amphotericin B. Currently, amphotericin B is the only FDAhyphenapproved drug for the treatment of mucormycosis, which also can be used to treat aspergillosis. The applicant's description of the technology was based on peer reviewed literature, which may be considered historical data.

    Comment: The applicant also presented with its comments findings from the Fungiscope Registry database to demonstrate the results of head-to-head comparisons between the efficacy of effectiveness of the CRESEMBAsupreg and other alternative therapies such as amphotericin B. The applicant stated that, in a matchedhyphencase control analysis, crude mortality through day 42 in patients who received treatment using CRESEMBAsupreg as primary therapy was 33.3 percent relative to 39.4 percent in patients who received amphotericinhyphenbased treatment as primary therapy from matched controls, while the overall mortality rate (37.8 percent) for patients treated using CRESEMBAsupreg was similar to the mortality rate for patients treated with amphotericin B as reported in the literature (37.8 percent).

    Response: We appreciate the information included in the applicant's comment in response to our concern. However, we believe that the crude mortality rates for both controls were similar, and the noted differences do not appear to be statistically significant.

    With regard to improved efficacy, the applicant made several assertions in its application that we discussed in the proposed rule (80 FR 24443 through 24444). The applicant maintained that the use of CRESEMBAsupreg can potentially decrease the rate of subsequent diagnostic or therapeutic interventions. According to the applicant, the technology lacks the adverse side effects of nephrotoxicity associated with amphotericin B.\20\ However, in the proposed rule we stated that the results of the study reported by the applicant did not reflect this.

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    \20\ Walsh TJ, Anaissie EJ, Denning DW, Herbrecht R, Kontoyiannis DP, Marr KA, et al.: Treatment of aspergillosis: Clinical practice guidelines of the Infectious Diseases Society of America. Clin Infect Dis. 2008;46:327-60.

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    Specifically, the applicant believed that CRESEMBAsupreg has positive activity against a broad range of fungi, including those resistant to other agents, thereby potentially decreasing subsequent therapeutic interventions.\21\ However, the applicant stated that the referenced literature indicates that further in-vivo studies are required in order to confirm the efficacy for treatment of severe infections caused by these fungi in immunocompromised patients. According to the applicant, CRESEMBAsupreg is used to treat immunocompromised patients who are severely ill. The applicant also stated that CRESEMBAsupreg can be used to treat patients diagnosed with invasive fungal infections before the pathogen has been identified, thereby potentially decreasing subsequent diagnostic and therapeutic interventions.\22\ The applicant maintained that the use of CRESEMBAsupreg decreases the number of future hospitalizations or physician visits. We stated in the proposed rule (80 FR 24444) our concern that the applicant did not provide data to support this determination. One of the applicant's studies, SECURE, which was a global, Phase 3, multicenter, randomized, double-blind, parallel group, noninferiority trial that evaluated CRESEMBAsupreg versus voriconazole for the primary treatment of patients with invasive fungal disease (IFDs) caused by aspergillus spp. and other filamentous fungi was discussed by the applicant in its application. The results of the study were presented in a paper stating that the length of stay for patients hospitalized with renal impairment was statistically significantly shorter in the treatment of patients in the CRESEMBAsupreg arm (9 days) compared with patients treated with voriconazole in the control arm. According to the applicant, patients treated with CRESEMBAsupreg showed shorter hospital length of stay compared to those treated with voriconazole in the overall study population. Subgroup analyses of patients who were aged 65 years and older and patients with a BMI equal to or greater than 30 kg/

    m2 also had shorter, but not statistically significant, differences in length of stay when treated with isavuconazonale compared to voriconazole. The paper on the study revealed concerns about the small sample size in the subgroup (n=516) and that the differences were not statistically significant.\23\

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    \21\ Gonzaacutelez GM.: Med Mycol. 2009 Feb;47(1):71-6. doi:10.1080/13693780802562969. Epub 2008 Dec 18. PMID: 19101837 PubMed--indexed for MEDLINE.

    \22\ Kontoyiannis DP, Lewis RE.: How I treat mucormycosis. Blood. 2011;118:1216-24.

    \23\ Khandelwal N, Franks B, Shi F, Spalding J, Azie N. Health Economic Outcome Analysis of Patients Randomized in the SECURE Phase 3 Trial Comparing Isavuconazole to Voriconazole for Primary Treatment of Invasive fungal Disease Caused by Aspsergillus Species or Other Filamentous Fungi.

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    With regard to improved safety and a more favorable pharmacokinetic profile, the applicant made several assertions which we discussed in the proposed rule (80 FR 24444). The applicant asserted that CRESEMBAsupreg has the potential for simpler and more predictable dosing based on improved pharmacokinetics compared with other azole antifungal drugs, but the applicant did not provide data to substantiate this assertion.

    Comment: The applicant provided the following information in its comment with regard to CRESEMBA's pharmacokinetic profile and predictable dosing. According to the applicant, based on data from the development of CRESEMBAsupreg and the prescribing information, CRESEMBAsupreg does not require therapeutic drug monitoring (TDM) compared to voricanozole, which requires TDM due to liver disease, age and genetic polymorphisim of the cytochrome CYP2C19. The applicant noted that, for CRESEMBAsupreg, no dose adjustment is required for the following: Age, gender, and race; mild, moderate, and severe renal impairment including patients with ESRD; mild to moderate hepatic impairment patients. The applicant included additional information from the Secure Phase III trial and other clinical studies 24 25 to substantiate that CRESEMBAsupreg has the potential for simpler and more predictable dosing based on improved pharmacokinetics compared with other azole antifungal drugs.

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    \24\ CRESEMBAsupreg package insert. Northbrook, IL: Astellas, Inc.

    \25\ Desai A, Kovanda L, Kowalski D, Lu Q, Townsend R. Isavuconazole (ISA) Population Pharmacokinetic Modeling from Phase 1 and Phase 3 Clinical Trials and Target Attainment Analysis. Proceedings of the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy Washington, DC Poster#A-697. 2014.

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    Response: We appreciate the additional information provided by the applicant. We note that, with regard to the pharmacokinetic profile, based on the information provided by the applicant, CRESEMBAsupreg appears to have a favorable profile, but the data relating to a comparison of rates for TEAEs between CRESEMBAsupreg and voriconazole show that the rates are the same. In addition, while the applicant stated that CRESEMBAsupreg does not require therapeutic drug monitoring (TDM) as compared to voricanozole, which does require TDM, we note that the FDA has indicated in the product labeling that serious hepatic reactions have been reported regarding the effects of the use of the CRESEMBAsupreg and the FDA has recommended that treatment include the evaluation of liver related laboratory tests at the start and during the course of treatment using the CRESEMBAsupreg therapy (similar to FDA indications for voricanozole).

    As we discussed in the proposed rule, the applicant also asserted that CRESEMBAsupreg has a lower drug-drug interaction potential than voriconazole or itraconazole, but did not provide data to substantiate this assertion. Furthermore, the applicant maintained that CRESEMBAsupreg can be safely used in treating patients with renal impairment, whereas currently available treatments can harm the kidneys.\26\ In the paper accompanying the application, the applicant discussed aspergillosis and the various treatment options available and the advantages of voriconazole over deoxycholate amphotericin B (D-AMB) as primary treatment for patients with invasive aspergillosis. In the proposed rule, we stated we were concerned that these results were not communicated in the resulting data provided by the applicant that were obtained from the trials (80 FR 24444).

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    \26\ Walsh TJ, Anaissie EJ, Denning DW, Herbrecht R, Kontoyiannis DP, Marr KA, et al. Treatment of aspergillosis: Clinical practice guidelines of the Infectious Diseases Society of America. Clin Infect Dis. 2008;46:327-60.

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    Comment: The applicant stated in its comment that based on the Phase 3 trials, 79 of 403 patients had an estimated glomerular filtration rate (GFR) less than 60 mL/min/1.73 m2. The applicant also provided data from a phase one study, which evaluated the pharmacokinetics in patients diagnosed with mild, moderate, and severe renal dysfunction relative to the pharmacokinetics in healthy patients with normal renal function.\27\ The applicant noted that CRESEMBAsupreg area under the curve 72 (AUC72) in ESRD patients is similar to the AUC72 in healthy controls due to the hemoconcentration because CRESEMBAsupreg is highly protein bound (>99 percent) and not dialyzable.

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    \27\ Astellas. CRESEMBAsupreg. Clinical Study Report No. 9766-

    CL-0018. Data on File.

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    The applicant presented the results from an analysis of a pooled subgroup from its previously stated studies (SECURE and VITAL), which evaluated the effectiveness of CRESEMBAsupreg in patients diagnosed with and without renal impairment, as defined as eGFR 2. The end points measured were all cause mortality at day 42 and day 84 and DRC assessed overall response at end of treatment (EOT). At the end of day 42, the mortality rates for the patients diagnosed with renal impairment versus patient who do not suffer from renal impaired was 12.9 percent versus 18.8 percent. At the end of day 84, the mortality rates for the patients diagnosed with renal impairment versus patients who do not suffer renal impairment was 25.8 percent versus 28.6 percent. All-cause mortality on Day 42 and Day 84, and DRC-assessed overall response at EOT were comparable between patient groups (32 percent versus 36 percent). The applicant stated that the results of this pooled analysis demonstrated that CRESEMBAsupreg was efficacious in patients diagnosed with renal impairment enrolled in the SECURE and VITAL trials and supports the Phase 1 trial findings that dose adjustments are not required for patients diagnosed with renal impairment treated using the CRESEMBAsupreg.

    Response: We appreciate the additional information provided in the applicant's comment in response to our concerns, and we have considered these findings in our final review.

    In the proposed rule, we also stated that we were concerned that the applicant did not provide a rationale for its assertion that the use of CRESEMBAsupreg represents a substantial clinical improvement for Medicare beneficiaries because of ``simpler and more predictable dosing'' nor did the applicant provide additional information and data regarding drug-to-drug interactions and nephrotoxicity (80 FR 24444).

    In addition, the applicant maintained that the technology has an improved method of administration compared to current treatment alternatives. Specifically, the applicant asserted that the availability of this technology as an oral formulation is an improvement compared to other existing treatments, which are solely administered intravenously. In the proposed rule, we stated that we were concerned about the applicant's assertion because other currently approved and available antifungal drugs, such as voriconazole (tablets, oral suspension, or intravenous administration), itraconazole (capsules, oral solution, or parenteral solution), and posaconazole (oral suspension or parenteral solution), also can be administered orally as well as parenteral for patients diagnosed with these types of fungal infections. In addition, we are aware that intravenous administration of antifungal drugs may be necessary because patients diagnosed with invasive aspergillosis and mucuromycosis and treated as inpatients are often severely ill and may

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    not be able to tolerate any food or medications orally.

    Comment: The applicant responded to CMS' concerns expressed in the proposed rule by presenting information that highlighted the following results based on data from the clinical studies: Both the oral and IV formulations have shown that CRESEMBAsupreg has a more predictable pharmacokinetic/pharmacodynamic profile when compared to voriconazole; CRESEMBAsupreg has moderate pharmacoki