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, 24323-24689 [2015-09245]

Download as PDF Vol. 80 Thursday, No. 83 April 30, 2015 Part II Department of Health and Human Services Centers for Medicare & Medicaid Services 42 CFR Part 412 Office of the Secretary tkelley on DSK3SPTVN1PROD with PROPOSALS2 45 CFR Part 170 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; Proposed Rule VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\30APP2.SGM 30APP2 24324 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 412 Office of the Secretary 45 CFR Part 170 [CMS–1632–P] RIN–0938–AS41 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the LongTerm 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 Centers for Medicare and Medicaid Services (CMS), HHS. ACTION: Proposed rule. AGENCY: We are proposing to revise 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, 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. We also are proposing to update 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 implement 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 proposing to establish new requirements or to revise existing requirements for quality reporting by specific providers (acute care hospitals, PPS-exempt cancer hospitals, and LTCHs) that are tkelley on DSK3SPTVN1PROD with PROPOSALS2 SUMMARY: VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 participating in Medicare, including related proposals for eligible hospitals and critical access hospitals participating in the Medicare Electronic Health Record (EHR) Incentive Program. We also are proposing to update policies relating to the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program. DATES: Comment Period: To be assured consideration, comments on all sections of this proposed rule must be received at one of the addresses provided in the ADDRESSES section no later than 5 p.m. EST on June 29, 2015. ADDRESSES: In commenting, please refer to file code CMS–1632–P. 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 https:// 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–P, 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–P, Mail Stop C4–26–05, 7500 Security Boulevard, Baltimore, MD 21244–1850. 4. By hand or courier. If you prefer, you may deliver (by hand or courier) your written comments before the close of the comment period to either of the following addresses: a. For delivery in Washington, DC— Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445–G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201. (Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.) b. For delivery in Baltimore, MD— Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244–1850. If you intend to deliver your comments to the Baltimore address, please call 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 HospitalAcquired 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, and Medicare Disproportionate Share Hospital (DSH) Issues. Michele Hudson, (410) 786–4487, Long-Term Care Hospital Prospective 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, PPSExempt Cancer Hospital Quality Reporting Issues. E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 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: 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: https:// www.regulations.gov. Follow the search instructions on that Web site to view public comments. tkelley on DSK3SPTVN1PROD with PROPOSALS2 Electronic Access 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 Publishing Office. This database can be accessed via the Internet at: https://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 proposed rule are available through the Internet on the CMS Web site at: https:// www.cms.hhs.gov/Medicare/medicareFee-for-Service-Payment/ AcuteInpatientPPS/. Click on the link on the left side of the screen titled, ‘‘FY 2016 IPPS Proposed Rule Home Page’’ or ‘‘Acute Inpatient—Files for Download’’. The LTCH PPS tables for this FY 2016 proposed rule are available through the Internet on the CMS Web site at: https://www.cms.gov/ Medicare/Medicare-Fee-for-ServicePayment/LongTermCareHospitalPPS/ index.html under the list item for Regulation Number CMS–1632–P. For further details on the contents of the tables referenced in this proposed rule, VerDate Sep<11>2014 22:00 Apr 29, 2015 Jkt 235001 we refer readers to section VI. of the Addendum to this proposed 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 PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 24325 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 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 E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 24326 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 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 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 diagnosisrelated group MS–LTC–DRG Medicare severity long-term care diagnosis-related group MU Meaningful Use [EHR Incentive Program] NAICS North American Industrial Classification System VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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 PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 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) 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 Proposed Rule 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) D. Summary of the Major Provisions of this Proposed Rule II. Proposed 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. Proposed FY 2016 MS–DRG Documentation and Coding Adjustment 1. Background on the Prospective MS–DRG Documentation and Coding Adjustments E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 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 a. Prospective Adjustment Required by Section 7(b)(1)(A) of Public Law 110–90 b. 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. Proposed 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 Request for Comments on Nonstandard Cost Center Codes F. Proposed 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. Proposed Changes to the HAC Program for FY 2016 6. RTI Program Evaluation 7. RTI Report on Evidence-Based Guidelines G. Proposed Changes to Specific MS–DRG Classifications 1. Discussion of Changes to Coding System and Basis for MS–DRG Updates a. Conversion of MS–DRGs to the International Classification of Diseases, 10th Edition (ICD–10) b. Basis for Proposed 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) a. Adding Severity Levels to MS–DRGs 245 Through 251 b. Percutaneous Intracardiac Procedures c. Zilver® PTX Drug-Eluting Peripheral Stent (ZPTX®) d. Percutaneous Mitral Valve Repair System—Proposed Revision of ICD–10– PCS Version 32 Logic e. Major Cardiovascular Procedures: Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft 4. MDC 8 (Diseases and Disorders of the Musculoskeletal System and Connective Tissue) a. Revision of Hip or Knee Replacement: Proposed Revision of ICD–10 Version 32 Logic b. Spinal Fusion VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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. Proposed Medicare Code Editor (MCE) Changes 9. Proposed Changes to Surgical Hierarchies 10. Proposed Changes to the MS–DRG Diagnosis Codes for FY 2016 a. Major Complications or Comorbidities (MCCs) and Complications or Comorbidities (CCs) Severity Levels for FY 2016 b. Coronary Atherosclerosis Due to Calcified Coronary Lesion c. Hydronephrosis 11. Proposed Complications or Comorbidity (CC) Exclusions List for FY 2016 a. Background b. Proposed CC Exclusions List for FY 2016 12. Review of Procedure Codes in MS– DRGs 981 Through 983, 984 Through 986, and 987 Through 989 a. Moving Procedure Codes From MS– DRGs 981 Through 983 or MS–DRGs 987 Through 989 Into MDCs b. Reassignment of Procedures Among MS– DRGs 981 Through 983, 984 through 986, and 987 Through 989 c. Adding Diagnosis or Procedure Codes to MDCs 13. Proposed Changes to the ICD–9–CM Coding System in FY 2016 a. ICD–10 Coordination and Maintenance Committee b. Code Freeze 14. Other Proposed Policy Change: Recalled/Replaced Devices H. Recalibration of the Proposed FY 2016 MS–DRG Relative Weights 1. Data Sources for Developing the Proposed Relative Weights 2. Methodology for Calculation of the Proposed Relative Weights 3. Development of Proposed National Average CCRs 4. Solicitation of Public Comments on Expanding the Bundled Payments for Care Improvement (BPCI) Initiative a. Background b. Considerations for Potential Model Expansion I. Proposed Add-On Payments for New Services and Technologies 1. Background 2. Public Input Before Publication of a Notice of Proposed Rulemaking on AddOn Payments 3. Implementation of ICD–10–PCS Section ‘‘X’’ Codes for Certain New Medical Services and Technologies for FY 2016 4. Proposed FY 2016 Status of Technologies Approved for FY 2015 Add-On Payments a. Glucarpidase (Voraxaze®) b. Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft c. KcentraTM PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 24327 d. Argus® II Retinal Prosthesis System e. Zilver®PTX® Drug-Eluting Peripheral Stent f. CardioMEMSTM HF (Heart Failure) Monitoring System g. MitraClip® System h. Responsive Neurostimulator (RNS® System) 5. FY 2016 Applications for New Technology Add-On Payments a. Angel Medical Guardian® Ischemia Monitoring Device b. Blinatumomab (BLINCYTOTM) c. Ceftazidime Avibactam (AVYCAZ) d. DIAMONDBACK® 360 Coronary Orbital Atherectomy System e. CRESEMBA® (Isavuconazonium) f. Idarucizumab g. LUTONIX® Drug Coated Balloon (DCB) Percutaneous Transluminal Angioplasty (PTA) and IN.PACTTMAdmiralTM Pacliaxel Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter h. VERASENSETM Knee Balancer System (VKS) i. WATCHMAN® Left Atrial Appendage Closure Technology III. Proposed 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 Proposed 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 D. Method for Computing the Proposed FY 2016 Unadjusted Wage Index E. Proposed Occupational Mix Adjustment to the Proposed FY 2016 Wage Index 1. Development of Data for the Proposed FY 2016 Occupational Mix Adjustment Based on the 2013 Medicare Wage Index Occupational Mix Survey 2. New 2013 Occupational Mix Survey Data for the Proposed FY 2016 Wage Index 3. Calculation of the Proposed Occupational Mix Adjustment for FY 2016 F. Analysis and Implementation of the Proposed Occupational Mix Adjustment and the Proposed 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. Proposed Application of the Rural, Imputed, and Frontier Floors 1. Proposed Rural Floor E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 24328 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 2. Proposed Imputed Floor for FY 2016 3. Proposed State Frontier Floor I. Proposed 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 a. FY 2016 Reclassification Requests and Approvals b. 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. Proposed Out-Migration Adjustment Based on Commuting Patterns of Hospital Employees 1. Background 2. New Data Source for the Proposed FY 2016 Out-Migration Adjustment 3. Proposed 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 Proposed FY 2016 Wage Index N. Proposed Changes to 3-Year Average for the FY 2017 Wage Index Pension Costs and Proposed 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 Proposed Changes to the IPPS for Operating Costs and Indirect Medical Education (IME) Costs A. Proposed Changes in the Inpatient Hospital Updates for FY 2016 (§§ 412.64(d) and 412.211(c)) 1. Proposed FY 2016 Inpatient Hospital Update 2. Proposed FY 2016 Puerto Rico Hospital Update B. Rural Referral Centers (RRCs): Proposed Annual Updates to Case-Mix Index (CMI) and Discharge Criteria (§ 412.96) 1. Case-Mix Index (CMI) 2. Discharges C. Indirect Medical Education (IME) Payment Adjustment for FY 2016 (§ 412.105) D. Proposed FY 2016 Payment Adjustment for Medicare Disproportionate Share Hospitals (DSHs) (§ 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 a. General Discussion b. Eligibility for Empirically Justified Medicare DSH Payments and Uncompensated Care Payments c. Empirically Justified Medicare DSH Payments d. Uncompensated Care Payments VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 E. Hospital Readmissions Reduction Program: Proposed Changes for FY 2016 Through FY 2017 (§§ 412.150 Through 412.154) 1. Statutory Basis for the Hospital Readmissions Reduction Program 2. Regulatory Background 3. Overview of Proposed Policies Changes for the FY 2016 and FY 2017 Hospital Readmissions Reduction Program 4. Proposed Refinement of Hospital 30Day, All Cause, Risk-Standardized Readmission Rate (RSSR) Following Pneumonia Hospitalization Measure Cohort (NQF #0506) for FY 2017 Payment Determination and Subsequent Years a. Background b. Overview of Measure Cohort Change c. Risk Adjustment d. Anticipated Effect of Refinement of Hospital 30-Day, All-Cause, RiskStandardized Readmission Rate (RSSR) Following Pneumonia Hospitalization Measure (NQF #0506) Cohort e. Calculating the Excess Readmissions Ratio 5. Maintenance of Technical Specifications for Quality Measures 6. Floor Adjustment Factor for FY 2016 (§ 412.154(c)(2)) 7. Proposed Applicable Period for FY 2016 8. Proposed Calculation of Aggregate Payments for Excess Readmissions for FY 2016 a. Background b. Proposed Calculation of Aggregate Payments for Excess Readmissions for FY 2016 9. Proposed Extraordinary Circumstances Exception Policy for the Hospital Readmissions Reduction Program Beginning FY 2016 and for Subsequent Years a. Background b. Requests for an Extraordinary Circumstances Exception F. Hospital Value-Based Purchasing (VBP) Program: Proposed Policy Changes for the FY 2018 Program Year and Subsequent Years 1. Background a. Statutory Background and Overview of Past Program Years b. FY 2016 Program Year Payment Details 2. Proposed Retention, Removal, Expansion, and Updating of Quality Measures for FY 2018 Program Year a. Retention of Previously Adopted Hospital VBP Program Measures for the FY 2018 Program Year b. Proposed Removal of Two Measures c. Proposed New Measure for the FY 2018 Program Year: 3-Item Care Transition Measure (CTM–3) (NQF #0228) d. Proposed Removal of Clinical Care— Process Subdomain for the FY 2018 Program Year and Subsequent Years e. NHSN Measures Standard Population Data f. Summary of Previously Adopted and Newly Proposed Measures for the FY 2018 Program Year 3. Previously Adopted and Newly Proposed Measures for the FY 2019, FY 2021, and Subsequent Program Years PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 a. Intent To Propose in Future Rulemaking To Include Selected Ward (NonIntensive Care Unit (ICU)) Locations in Certain NHSN Measures Beginning With the FY 2019 Program Year b. Proposed New Measure for the FY 2021 Program Year: Hospital 30-Day, AllCause, Risk-Standardized Mortality Rate Following Chronic Obstructive Pulmonary Disease (COPD) Hospitalization (NQF #1893) c. Summary of Previously Adopted and Newly Proposed Measures for the FY 2019 and FY 2021 and Subsequent Program Years 4. Possible Measure Topics for Future Program Years 5. Previously Adopted and Newly Proposed Baseline and Performance Periods for the FY 2018 Program Year a. Background b. Proposed Baseline and Performance Periods for the Patient and CaregiverCentered Experience of Care/Care Coordination Domain for the FY 2018 Program Year c. Proposed Baseline and Performance Periods for NHSN Measures and PC–01 in the Safety Domain for the FY 2018 Program Year d. Proposed Baseline and Performance Periods for the Efficiency and Cost Reduction Domain for the FY 2018 Program Year e. Summary of Previously Finalized and Newly Proposed Baseline and Performance Periods for the FY 2018 Program Year 6. Previously Adopted and Newly Proposed Baseline and Performance Periods for Future Program Years a. Previously Adopted Baseline and Performance Periods for the FY 2019 Program b. Proposed Baseline and Performance Periods for the PSI–90 Measure in the Safety Domain in the FY 2020 Program Years c. Proposed Baseline and Performance Periods for the Clinical Care Domain for the FY 2021 Program Year 7. Proposed Performance Standards for the Hospital VBP Program a. Background b. Technical Updates c. Proposed Performance Standards for the FY 2018 Program Year d. Previously Adopted Performance Standards for Certain Measures for the FY 2019 Program Year e. Previously Adopted and Newly Proposed Performance Standards for Certain Measures for the FY 2020 Program Year f. Proposed Performance Standards for Certain Measures for the FY 2021 Program Year 8. Proposed FY 2018 Program Year Scoring Methodology a. Proposed Domain Weighting for the FY 2018 Program Year for Hospitals That Receive a Score on All Domains b. Proposed Domain Weighting for the FY 2018 Program Year for Hospitals Receiving Scores on Fewer Than Four Domains E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules G. Proposed Changes to the HospitalAcquired 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. Proposed Changes for Implementation of the HAC Reduction Program for FY 2017 a. Proposed Applicable Time Period for the FY 2017 HAC Reduction Program b. Proposed Narrative Rule Used in Calculation of the Domain 2 Score for the FY 2017 HAC Reduction Program c. Proposed Domain 1 and Domain 2 Weights for the FY 2017 HAC Reduction Program 6. Proposed Measure Refinements for the FY 2018 HAC Reduction Program a. Proposal To Include Select Ward (NonIntensive Care Unit (ICU)) Locations in Certain CDC NHSN Measures Beginning in the FY 2018 Program Year b. Update to CDC NHSN Measures Standard Population Data 7. Maintenance of Technical Specifications for Quality Measures 8. Proposed Extraordinary Circumstances Exception Policy for the HAC Reduction Program Beginning in FY 2016 and for Subsequent Years a. Background b. Requests for an Extraordinary Circumstances Exception H. Proposed Elimination of Simplified Cost Allocation Methodology 1. Background 2. Proposed Changes I. Rural Community Hospital Demonstration Program 1. Background 2. Proposed FY 2016 Budget Neutrality Offset Amount J. Proposed Changes to MS–DRGs Subject to the Postacute Care Transfer Policy (§ 412.4) 1. Background 2. Proposed Changes to the Postacute Care Transfer MS–DRGs K. Short Inpatient Hospital Stays V. Proposed Changes to the IPPS for CapitalRelated Costs A. Overview B. Additional Provisions 1. Exception Payments 2. New Hospitals 3. Hospitals Located in Puerto Rico C. Proposed Annual Update for FY 2016 VI. Proposed Changes for Hospitals Excluded From the IPPS VII. Proposed 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 a. Classification as an LTCH b. 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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 B. Proposed Application of Site Neutral Payment Rate (Proposed New § 412.522) 1. Overview 2. Proposed Application of the Site Neutral Payment Rate Under the LTCH PPS 3. Criteria for Exclusion From the Site Neutral Payment Rate a. Statutory Provisions b. Proposed Implementation of Criterion for a Principal Diagnosis Relating to a Psychiatric Diagnosis or to Rehabilitation c. Proposed Addition of Definition of ‘‘Subsection (d) Hospital’’ to LTCH Regulations d. Proposed Interpretation of ‘‘Immediately Preceded’’ by a Subsection (d) Hospital Discharge e. Proposed Implementation of Intensive Care Unit (ICU) Criterion f. Proposed Implementation of the Ventilator Criterion 4. Proposed Determination of the Site Neutral Payment Rate (Proposed New § 412.522(c)) a. General b. Proposed Blended Payment Rate for FY 2016 and FY 2017 c. Proposed LTCH PPS Standard Federal Payment Rate 5. Proposed Application of Certain Exiting LTCH PPS Payment Adjustments to Payments Made Under the Site Neutral Payment Rate 6. Proposals Relating to the 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 a. MS–LTC–DRG Relative Payment Weights b. High-Cost Outliers c. Limitation on Charges to Beneficiaries C. Proposed 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 a. Background b. Proposed Changes to the MS–LTC–DRGs for FY 2016 3. Development of the Proposed FY 2016 MS–LTC–DRG Relative Weights a. General Overview of the Development of the MS–LTC–DRG Relative Weights b. Development of the Proposed MS–LTC– DRG Relative Weights for FY 2016 c. Data d. Hospital-Specific Relative Value (HSRV) Methodology e. Treatment of Severity Levels in Developing the Proposed MS–LTC–DRG Relative Weights f. Proposed Low-Volume MS–LTC–DRGs g. Steps for Determining the Proposed FY 2016 MS–LTC–DRG Relative Weights D. Proposed Changes to the LTCH PPS Standard Payment Rates for FY 2016 1. Overview of Development of the LTCH PPS Standard Federal Payment Rates 2. Proposed FY 2016 LTCH PPS Annual Market Basket Update a. Overview PO 00000 Frm 00007 Fmt 4701 Sfmt 4702 24329 b. Proposed Revision of Certain Market Basket Updates as Required by the Affordable Care Act c. Proposed Adjustment to the Annual Update to the LTCH PPS Standard Federal Rate Under the Long-Term Care Hospital Quality Reporting Program (LTCH QRP) d. Proposed Market Basket Under the LTCH PPS for FY 2016 e. Proposed 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. Proposed Changes to Average Length of Stay Criterion Under Public Law 113–67 (§ 412.23) VIII. Proposed Quality Data Reporting Requirements for Specific Providers and Suppliers for FY 2016 A. Hospital Inpatient Quality Reporting (IQR) Program 1. Background a. History of the Hospital IQR Program b. Maintenance of Technical Specifications for Quality Measures c. 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 a. Considerations in Removing Quality Measures From the Hospital IQR Program b. Proposed Removal of Hospital IQR Program Measures for the FY 2018 Payment Determination and Subsequent Years 4. Previously Adopted Hospital IQR Program Measures for the FY 2017 Payment Determination and Subsequent Years a. Background b. NHSN Measures Standard Population Data 5. Expansion and Updating of Quality Measures 6. Proposed Refinements of Existing Measures in the Hospital IQR Program a. Proposed Refinement of Hospital 30-Day, All-Cause, Risk-Standardized Mortality Rate (RSMR) Following Pneumonia Hospitalization (NQF #0468) Measure Cohort b. Proposed Refinement of Hospital 30Day, All-Cause, Risk-Standardized Readmission Rate (RSRR) Following Pneumonia Hospitalization (NQF #0468) Measure Cohort 7. Proposed Additional Hospital IQR Program Measures for the FY 2018 Payment Determination and Subsequent Years a. Hospital Survey on Patient Safety Culture b. Clinical Episode-Based Payment Measures c. 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) E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 24330 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules d. Excess Days in Acute Care After Hospitalization for Acute Myocardial Infarction e. Excess Days in Acute Care After Hospitalization for Heart Failure f. Summary of Previously Adopted and Proposed Hospital IQR Program Measure Set for the FY 2018 Payment Determination and Subsequent Years 8. Electronic Clinical Quality Measures a. Previously Adopted Voluntarily Reported Electronic Clinical Quality Measures for the FY 2017 Payment Determination b. Clarification of the Venous Thromboembolism (VTE) Prophylaxis (STK–01) Measure (NQF #0434) c. Proposed 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 a. Background b. Overview of Core Clinical Data Elements c. Core Clinical Data Elements Development d. Core Clinical Data Elements Feasibility Testing Using Readmission and Mortality Models e. Use of Core Clinical Data Elements in Hospital Quality Measures for the Hospital IQR Program f. Content Exchange Standard Considerations for Core Clinical Data Elements 10. Form, Manner, and Timing of Quality Data Submission a. Background b. Procedural Requirements for the FY 2018 Payment Determination and Subsequent Years c. Data Submission Requirements for Chart-Abstracted Measures d. Alignment of the Medicare EHR Incentive Program Reporting for Eligible Hospitals and CAHs With the Hospital IQR Program e. Sampling and Case Thresholds for the FY 2018 Payment Determination and Subsequent Years f. HCAHPS Requirements for the FY 2018 Payment Determination and Subsequent Years g. Data Submission Requirements for Structural Measures for the FY 2018 Payment Determination and Subsequent Years h. Data Submission and Reporting Requirements for Healthcare-Associated Infection (HAI) Measures Reported via NHSN 11. Proposed Modifications to the Existing Processes for Validation of Hospital IQR Program Data a. Background b. Proposed Modifications to the Existing Processes for Validation of ChartAbstracted Hospital IQR Program Data 12. Data Accuracy and Completeness Acknowledgement Requirements for the FY 2018 Payment Determination and Subsequent Years VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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. Proposed 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. Proposed New Quality Measures Beginning With the FY 2018 Program a. Considerations in the Selection of Quality Measures b. Summary of Proposed New Measures c. CDC NHSN Facility-Wide Inpatient Hospital-Onset Clostridium difficile (C. difficile) Infection (CDI) Outcome Measure (NQF #1717) d. CDC NHSN Facility-Wide Inpatient Hospital-Onset Methicillin-Resistant Staphylococcus Aureus (MSRA) Bacteremia Outcome Measure (NQF #1716) e. 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 a. Background b. Proposed Additional Public Display Requirements 7. Form, Manner, and Timing of Data Submission a. Background b. 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 a. Previously Adopted Quality Measures for the FY 2015 and FY 2016 Payment Determinations and Subsequent Years b. 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 a. Proposal To Reflect NQF Endorsement: All-Cause Unplanned Readmission Measure for 30 Days Post-Discharge From LTCHs (NQF #2512) b. Proposal To Address the IMPACT Act of 2014: Quality Measure Addressing the PO 00000 Frm 00008 Fmt 4701 Sfmt 4702 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) c. Proposal 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) d. Proposal 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 a. Background b. Proposed Timing for New LTCHs To Begin Reporting Data to CMS for the FY 2017 Payment Determinations and Subsequent Years c. Proposed Revisions to Previously Adopted Data Submission Timelines Under the LTCH QRP for the FY 2017 and FY 2018 Payment Determinations and Subsequent Years and Proposed Data Collection and Data Submission Timelines for Quality Measures Proposed in This Proposed Rule 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. Proposed Public Display of Quality Measure Data for the LTCH QRP 13. Previously Adopted and Proposed LTCH QRP Reconsideration and Appeals Procedures for the FY 2017 Payment Determination and Subsequent Years 14. Previously Adopted and Proposed 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 Participating in the EHR Incentive Programs in 2016 1. Background 2. CQM Reporting for the Medicare and Medicaid EHR Incentive Programs in 2016 a. Background b. Proposed CQM Reporting Period for the Medicare and Medicaid EHR Incentive Programs for CY 2016 c. CQM Form and Method for the Medicare EHR Incentive Programs for 2016 3. Certified EHR Technology for CQMs for the EHR Incentive Programs in 2016 E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules a. Edition of Certified EHR Technology Requirements for 2016 b. ‘‘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 Proposed Occupational Mix Adjustment to the Proposed 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) C. Response to Comments Regulation Text Addendum—Proposed Schedule of Standardized Amounts, Update Factors, and Rate-of-Increase Percentages Effective With Cost Reporting Periods Beginning on or After October 1, 2015 and Proposed Payment Rates for LTCHs Effective With Discharges Occurring on or After October 1, 2015 I. Summary and Background II. Proposed 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. Proposed MS–DRG Relative Weights D. Calculation of the Prospective Payment Rates III. Proposed Changes to Payment Rates for Acute Care Hospital Inpatient CapitalRelated Costs for FY 2016 A. Determination of Federal Hospital Inpatient Capital-Related Prospective Payment Rate Update B. Calculation of the Proposed Inpatient Capital-Related Prospective Payments for FY 2016 C. Capital Input Price Index IV. Proposed Changes to Payment Rates for Excluded Hospitals: Rate-of-Increase Percentages for FY 2016 V. Proposed Updates to the Payment Rates for the LTCH PPS for FY 2016 A. Proposed LTCH PPS Standard Federal Rate for FY 2016 1. Background 2. Development of the Proposed FY 2016 LTCH PPS Standard Federal Rate B. Proposed Adjustment for Area Wage Levels Under the LTCH PPS Standard Federal Payment Rate for FY 2016 1. Background 2. Proposed Geographic Classifications (Labor Market Areas) for the LTCH PPS Standard Federal Payment Rate VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 3. Proposed Labor-Related Share for the LTCH PPS Standard Federal Payment Rate 4. Proposed Wage Index for FY 2016 for the LTCH PPS Standard Federal Payment Rate 5. Proposed Budget Neutrality Adjustment for Proposed Changes to the LTCH PPS Standard Federal Payment Rate Area Wage Level Adjustment C. Proposed LTCH PPS Cost-of-Living Adjustment (COLA) for LTCHs Located in Alaska and Hawaii D. Proposed Adjustment for LTCH PPS High-Cost Outlier (HCO) Cases 1. Overview 2. Determining Proposed LTCH CCRs Under the LTCH PPS 3. Proposed High-Cost Outlier Payments for LTCH PPS Standard Federal Payment Rate Cases 4. Proposed High-Cost Outlier Payments for Site Neutral Payment Rate Cases E. Proposed Update to the IPPS Comparable/Equivalent Amounts To Reflect the Statutory Changes to the IPPS DSH Payment Adjustment Methodology F. Computing the Proposed Adjusted LTCH PPS Federal Prospective Payments for FY 2016 VI. Tables Referenced in This Proposed Rule 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 Proposed 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 Proposed Policy Changes 1. Effects of Proposed Policy on MS–DRGs for Preventable HACs, Including Infections 2. Effects of Proposed Policy Relating to New Medical Service and Technology Add-On Payments 3. Effects of Proposed Changes in Medicare DSH Payments for FY 2016 4. Effects of Proposed Reductions Under the Hospital Readmissions Reduction Program 5. Effects of Proposed Changes Under the FY 2016 Hospital Value-Based Purchasing (VBP) Program 6. Effects of Proposed Changes to the HAC Reduction Program for FY 2016 7. Effects of Proposed Elimination of the Simplified Cost Allocation Methodology 8. Effects of Implementation of Rural Community Hospital Demonstration Program 9. Effects of Proposed Changes to List of MS–DRGs Subject to Postacute Care Transfer and DRG Special Pay Policy I. Effects of Proposed Changes in the Capital IPPS PO 00000 Frm 00009 Fmt 4701 Sfmt 4702 24331 1. General Considerations 2. Results J. Effects of Proposed Payment Rate Changes and Proposed Policy Changes Under the LTCH PPS 1. Introduction and General Considerations 2. Impact on Rural Hospitals 3. Anticipated Effects of Proposed LTCH PPS Payment Rate Changes and Proposed Policy Changes 4. Effect on the Medicare Program 5. Effect on Medicare Beneficiaries K. Effects of Proposed Requirements for Hospital Inpatient Quality Reporting (IQR) Program L. Effects of Proposed Requirements for the PPS-Exempt Cancer Hospital Quality Reporting (PCHQR) Program for FY 2016 M. Effects of Proposed Requirements for the LTCH Quality Reporting Program (LTCH QRP) for FY 2016 Through FY 2020 N. Effects of Proposed 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. Proposed Inpatient Hospital Updates for FY 2016 A. Proposed FY 2016 Inpatient Hospital Update B. Proposed Update for SCHs for FY 2016 C. Proposed FY 2016 Puerto Rico Hospital Update D. Proposed Update for Hospitals Excluded From the IPPS for FY 2016 E. Proposed Update for LTCHs for FY 2016 III. Secretary’s Recommendation 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 proposed rule would make payment and policy changes under the Medicare inpatient prospective payment systems (IPPS) for operating and capitalrelated costs of acute care hospitals as well as for certain hospitals and hospital units excluded from the IPPS. In addition, it would make payment and policy changes for inpatient hospital services provided by long-term care hospitals (LTCHs) under the long-term care hospital prospective payment E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 24332 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules system (LTCH PPS). It also would make policy changes to programs associated with Medicare IPPS hospitals, IPPSexcluded hospitals, and LTCHs. Under various statutory authorities, we are proposing to make 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 hospitalacquired 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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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 HospitalAcquired Condition (HAC) Reduction Program, under which payments to applicable hospitals are adjusted to provide an incentive to reduce hospitalacquired conditions. • Section 1886(q) of the Act, as added by section 3025 of the Affordable Care Act and amended by section 10309 of PO 00000 Frm 00010 Fmt 4701 Sfmt 4702 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 now 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); 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 patient criteria for payment under the LTCH PPS for 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 25percent threshold payment adjustment policy under the LTCH PPS so that the policy will be in effect for 9 years (except for ‘‘grandfathered’’ hospitalwithin-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) E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 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. 2. Summary of the Major Provisions tkelley on DSK3SPTVN1PROD with PROPOSALS2 a. 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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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. We are proposing to make an additional ¥0.8 percent recoupment adjustment to the standardized amount in FY 2016. b. Reduction of Hospital Payments for Excess Readmissions We are proposing 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 proposed rule, we are proposing a refinement to the pneumonia readmissions measure, which would expand the measure cohort for the FY 2017 payment determination and subsequent years. In addition, we are proposing to adopt an extraordinary circumstance exception policy that would align with existing extraordinary circumstance exception policies for other IPPS quality reporting and payment programs and would 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. c. 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. PO 00000 Frm 00011 Fmt 4701 Sfmt 4702 24333 For FY 2016, we are proposing to adopt one additional measure beginning with the FY 2018 program year and one measure beginning with the FY 2021 program year. We also are proposing to remove two measures beginning with the FY 2018 program year. In addition, we are proposing to move one measure to the Safety domain and to remove the Clinical Care—Process subdomain and rename the Clinical Care—Outcomes subdomain 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. d. 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 1percent 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 proposed rule, we are proposing 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 would align with existing extraordinary circumstance exception policies for other IPPS quality reporting and payment programs and would allow hospitals to request a waiver for use of data from the affected time period. E:\FR\FM\30APP2.SGM 30APP2 24334 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules e. 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 current 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 proposed rule, we are proposing to update our estimates of the three factors used to determine uncompensated care payments for FY 2016. We are proposing to continue 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 proposing a change to the time period of the data used to calculate the uncompensated care payment amounts to be distributed. tkelley on DSK3SPTVN1PROD with PROPOSALS2 f. Proposed Changes to the LTCH PPS Under the current LTCH PPS, all discharges are paid under the LTCH PPS standard Federal payment rate. In this proposed rule, we are proposing to implement section 1206 of the Pathways for SGR Reform Act, which requires the establishment of an alternative site neutral payment rate for Medicare inpatient 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 proposals regarding the application of the site neutral payment rate and the criteria for exclusion from the site neutral payment rate, as well as proposals 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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 (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 proposing 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 proposing a technical revision to the regulations to more clearly reflect our established policies. g. 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 proposed rule, we are proposing to update considerations for measure removal and retention. In addition, we are proposing to remove nine measures for the FY 2018 payment determination and subsequent years: Six of these measures are ‘‘topped-out’’ and two of the measures are suspended. However, we are retaining the electronic version of six of these measures. We also are proposing to refine two previously adopted measures as well as for the FY 2018 payment determination and subsequent years and add eight new measures: Seven new claims-based measures and one structural measure. Further, for the FY 2018 payment determination, we are proposing to require hospitals to report 16 of the 28 electronic clinical quality measures under the Hospital IQR Program that align with the Medicare EHR Incentive Program and span 3 different NQS domains. We also are proposing to require that hospitals submit two quarters (Q3 and Q4) of data within 2 months following the last discharge date of the quarter. We are proposing to delay and footnote public reporting of electronic clinical quality measure data submitted by hospitals for the CY 2016/ FY 2018 payment determination. PO 00000 Frm 00012 Fmt 4701 Sfmt 4702 We are proposing to align the reporting and submission timelines for the electronic submission of clinical quality measures for the Medicare EHR Incentive Program for eligible hospitals and critical access hospitals (CAHs) with the reporting and submission timelines for the Hospital IQR Program. Lastly, ONC is proposing a 2015 Edition certification criterion for ‘‘CQMs— report’’ as part of the proposed 2015 Edition of certification criteria that would require a certified Health IT Module to enable a user to electronically create a data file for transmission of clinical quality measurement data. This proposed certification criterion would apply to eligible professionals, eligible hospitals, and CAHs. h. 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 proposed rule, we are proposing three previously finalized quality measures: One measure proposal establishes the newly NQF-endorsed status of that quality measure; two other E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules tkelley on DSK3SPTVN1PROD with PROPOSALS2 measure proposals 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 proposing to adopt 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 measure proposals effect the FY 2018 annual payment update determination and beyond. In addition, we are proposing to publicly report LTCH quality data beginning in fall 2016, on a CMS Web site, such as Hospital Compare. We are proposing to initially publicly report quality data on four quality measures. Finally, we are proposing to lengthen 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 proposing 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 proposing to make 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 proposed 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, VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 we are proposing to make a ¥0.8 percent recoupment adjustment to the standardized amount in FY 2016. Considering the ¥0.8 percent adjustments made in FY 2014 and FY 2015, we estimate that the combined impact of the proposed adjustment for FY 2016 and leaving the FY 2014 and FY 2015 adjustments in place would be to recover up to $3 billion in FY 2016. Combined with the effects of the ¥0.8 percent adjustments implemented in FY 2014 and FY 2015, we estimate that the proposed FY 2016 ¥0.8 percent adjustment would result in the recovery of a total of approximately $6 billion of the $11 billion in overpayments required to be recovered by section 631 of the ATRA. • Proposed Changes to the Hospital Readmissions Reduction Program. We are proposing a refinement to the pneumonia readmissions measure, which would expand the measure cohort for the FY 2017 payment determination and subsequent years. In addition, we are proposing to adopt an extraordinary circumstance exception policy that would align with existing extraordinary circumstance exception policies for other IPPS quality reporting and payment programs and would 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 proposed changes would not significantly impact the program in FY 2016, but could impact future years, depending on actual experience. • Value-Based Incentive Payments under the Hospital VBP Program. We estimate that there would 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 2016 discharges is approximately $1.5 billion. We believe that the program benefits will be seen in improved patient outcomes, safety, and in the patient’s experience of care. However, we cannot estimate these benefits in actual dollar and patient terms. • Proposed Changes to the HAC Reduction Program for FY 2016. We are proposing three changes to existing HAC Reduction Program policies: (1) An expansion to the population covered by PO 00000 Frm 00013 Fmt 4701 Sfmt 4702 24335 the central line-associated bloodstream infection (CLABSI) and catheterassociated 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 would align with existing extraordinary circumstance exception policies for other IPPS quality reporting and payment programs and would allow hospitals to request a waiver for use of data from the affected period. While hospitals in the top quartile of HAC scores will continue to have their HAC Reduction Program payment adjustment applied, as required by law, 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 proposed changes, including which hospitals receive the adjustment, would 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 proposing to provide 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, E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 24336 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 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 payment 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 would 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 proposed payment amount is not directly tied to a hospital’s number of discharges. • Proposed Update to the LTCH PPS Payment Rates and Other Payment Factors. Based on the best available data for the 418 LTCHs in our data base, we estimate that the proposed changes to the payment rates and factors that we are presenting in the preamble and Addendum of this proposed rule, including the proposed application of the new site neutral payment rate required by section 1886(m)(6)(A) of the Act, the proposed update to the LTCH PPS standard Federal rate for FY 2016, and the proposed changes to short-stay outlier and high-cost outlier payments would result in an estimated decrease in payments from FY 2015 of approximately $251 million (or 4.6 percent). • Hospital Inpatient Quality Reporting (IQR) Program. In this proposed rule, we are proposing to remove nine measures for the FY 2018 payment determination and subsequent years. We are proposing to add eight measures to the hospital IQR Program for the FY 2018 payment determination and subsequent years. We also are proposing to require hospitals to report 16 of the 28 Hospital IQR Program electronic clinical quality measures that align with the Medicare EHR Incentive Program and span three different NQS domains. We estimate that our proposals 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 proposals in this proposed rule is zero. We refer readers to sections VIII.C. of the VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 preamble of this proposed rule for detailed discussion of the proposals. 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 laborrelated 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 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 provides for a new additional Medicare payment that considers the amount of uncompensated care beginning on October 1, 2013. 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 PO 00000 Frm 00014 Fmt 4701 Sfmt 4702 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 hospitalspecific 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. (We note that the statutory provision for Medicare payments to MDHs expired on March 31, 2015, under current law.) 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. 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 E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules are located in 42 CFR part 412, subparts A through M. tkelley on DSK3SPTVN1PROD with PROPOSALS2 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; longterm 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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 based on an increasing proportion of the LTCH Federal rate with a corresponding 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 rate. The existing regulations governing payment under the LTCH PPS are located in 42 CFR part 412, subpart O. Beginning with FY 2009, annual updates to the LTCH PPS are published in the same documents that update the IPPS (73 FR 26797 through 26798). 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 Proposed 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 PO 00000 Frm 00015 Fmt 4701 Sfmt 4702 24337 Public Law 112–240 in a notice that appeared in the Federal Register on March 7, 2013 (78 FR 14689). The Pathway for Sustainable Growth Rate (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). 1. American Taxpayer Relief Act of 2012 (ATRA) (Pub. L. 112–240) In this proposed rule, we are proposing to make 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 Sustainable Growth Rate (SGR) Reform Act of 2013 (Pub. L. 113– 67) In this proposed rule, we are proposing to make policy changes to implement and discuss the need for future policy changes to carry out 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 E:\FR\FM\30APP2.SGM 30APP2 24338 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 10312(a) of the Affordable Care Act by retroactively reestablishing, and extending, the statutory moratorium on the full implementation of the 25percent threshold payment adjustment policy under the LTCH PPS so that the policy will be in effect for 9 years (except for grandfathered hospitalswithin-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 proposed rule, we are proposing to make policy changes to implement, or making conforming changes to regulations in accordance with, 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. tkelley on DSK3SPTVN1PROD with PROPOSALS2 4. Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act of 2014) (Pub. L. 113–185) In this proposed rule, we are proposing to implement 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. D. Summary of the Major Provisions of This Proposed Rule In this proposed rule, we set forth proposed changes to the Medicare IPPS for operating costs and for capitalrelated costs of acute care hospitals for FY 2016. We also set forth proposed changes relating to payments to certain hospitals that continue to be excluded from the IPPS and paid on a reasonable cost basis. In addition, in this proposed rule, we set forth proposed changes to VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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 are proposing to make: 1. Proposed Changes to MS–DRG Classifications and Recalibrations of Relative Weights In section II. of the preamble of this proposed rule, we include— • 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 hospitalacquired 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 addon 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 this proposed rule, we are proposing 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. • Proposed application of the rural floor, the proposed imputed rural floor, and the proposed 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. PO 00000 Frm 00016 Fmt 4701 Sfmt 4702 • 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 are proposing 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 this proposed rule, we discuss 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 valuebased 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 E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 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 that will be published this summer. 4. Proposed FY 2016 Policy Governing the IPPS for Capital-Related Costs In section V. of the preamble to this proposed rule, we discuss 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 this proposed rule, we discuss proposed changes to payments to certain excluded hospitals for FY 2016. tkelley on DSK3SPTVN1PROD with PROPOSALS2 6. Proposed Changes to the LTCH PPS In section VII. of the preamble of this 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 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 this proposed rule, we address— • Proposed requirements for the Hospital Inpatient Quality Reporting (IQR) Program as a condition for receiving the full applicable percentage increase. VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 • 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, including a proposal to establish in regulations an EHR technology certification criterion for reporting clinical quality measures. 8. Determining Prospective Payment Operating and Capital Rates and Rate-ofIncrease Limits for Acute Care Hospitals In the Addendum to this 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 are proposing to establish the threshold amounts for outlier cases. In addition, we address 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 this 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 are proposing to establish the adjustments for wage levels, the labor-related share, the cost-of-living adjustment, and highcost 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 this 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 this proposed rule, as required by sections 1886(e)(4) and (e)(5) of the Act, we provide our recommendations of the appropriate percentage changes for FY 2016 for the following: • A single average standardized amount for all areas for hospital PO 00000 Frm 00017 Fmt 4701 Sfmt 4702 24339 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 address 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: https://www.medpac.gov. II. Proposed 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 E:\FR\FM\30APP2.SGM 30APP2 24340 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 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 with comment period (72 FR 47140 through 47189). D. Proposed FY 2016 MS–DRG Documentation and Coding Adjustment tkelley on DSK3SPTVN1PROD with PROPOSALS2 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. (Currently, for FY 2015, there are 775 MS–DRGs.) 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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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 a. 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 PO 00000 Frm 00018 Fmt 4701 Sfmt 4702 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. b. 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 E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules tkelley on DSK3SPTVN1PROD with PROPOSALS2 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 effects. Interested individuals may still order these files through the CMS Web site at: https://www.cms.gov/ResearchStatistics-Data-and-Systems/Files-forOrder/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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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 PO 00000 Frm 00019 Fmt 4701 Sfmt 4702 24341 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. E:\FR\FM\30APP2.SGM 30APP2 24342 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules tkelley on DSK3SPTVN1PROD with PROPOSALS2 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 adjustment to the standardized amount finalized for FY 2011 (76 FR 51489 and 51498). Because these adjustments, in effect, balanced out, there was no yearto-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. Proposed 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. VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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, any adjustment made to reduce payment rates in one year would eventually be offset by a positive adjustment, once the necessary amount of overpayment is recovered. 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, will 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 PO 00000 Frm 00020 Fmt 4701 Sfmt 4702 billion required by section 631 of the ATRA, in this FY 2016 IPPS/LTCH PPS proposed rule, we are proposing to implement a ¥0.8 percent recoupment adjustment to the standardized amount for FY 2016. Considering the ¥0.8 percent adjustments made in FY 2014 and FY 2015, we estimate that the combined impact of the proposed adjustment for FY 2016 and leaving the FY 2014 and FY 2015 adjustments in place would be to recover up to $3 billion in FY 2016. Combined with the effects of the ¥0.8 percent adjustments implemented in FY 2014 and FY 2015, we estimate that the proposed FY 2016 ¥0.8 percent adjustment would result in the recovery of a total of approximately $6 billion of the $11 billion in overpayments required to be recovered by section 631 of the ATRA. As we explained in the FY 2014 IPPS/ LTCH PPS final rule, estimates of any future adjustments are subject to slight variations in total 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 continue to believe that the proposed ¥0.8 percent adjustment for FY 2016 is a reasonable and fair approach that will help satisfy the requirements of the statute while mitigating extreme annual fluctuations in payment rates. In addition, we again note that this proposed ¥0.8 percent recoupment adjustment for FY 2016, the respective ¥0.8 percent adjustments made in FY 2014 and FY 2015, and any future adjustment made under this authority, will be eventually offset by an equivalent positive adjustment once the full $11 billion recoupment requirement has been realized. 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 costbased DRG relative weights and to the 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 E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 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 costto-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’’ (https:// www.rti.org/reports/cms/HHSM-5002005-0029I/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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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 PO 00000 Frm 00021 Fmt 4701 Sfmt 4702 24343 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 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 E:\FR\FM\30APP2.SGM 30APP2 24344 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules tkelley on DSK3SPTVN1PROD with PROPOSALS2 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 Request for Comments on Nonstandard Cost Center Codes Consistent with the policy established beginning for FY 2014, we calculated the proposed 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 proposed 19 CCRs and VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 the proposed MS–DRG relative weights for FY 2016 is included in section II.H.3. of the preamble of this proposed 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. 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 CMSapproved 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 PO 00000 Frm 00022 Fmt 4701 Sfmt 4702 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 § 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 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 softwares do not prevent hospitals from manually entering in a name for a nonstandard cost center code that may E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules tkelley on DSK3SPTVN1PROD with PROPOSALS2 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 are calculated, reveals that, of the 3,172 times that nonstandard code 03020 is 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’’. 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 are 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 1 To view how CMS rolls up the codes to create the HCRIS SAS files, we refer readers to https:// www.cms.gov/Research-Statistics-Data-andSystems/Downloadable-Public-Use-Files/CostReports/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). VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 and places them in different standard cost centers based on CMS’ roll-up specifications. We are highlighting 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 this proposed rule, the proposed FY 2016 CCR for Anesthesia is 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 roll 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 retains 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 this 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, two other CCRs also are affected, although not quite as significantly as the Anesthesia CCR. Currently, as proposed in section II.H.3. of the preamble of this proposed rule, the proposed FY 2016 Cardiology CCR is 0.119, but when all cardiology-related nonstandard codes are rolled up to standard line 76, ‘‘Other Ancillary’’, and not to standard line 69, ‘‘Electrocardiology’’ as under CMS’ usual practice, the Cardiology CCR would be 0.113. In addition, as proposed in section II.H.3. of the preamble of this proposed rule, the proposed FY 2016 Radiology CCR is 0.159, but when all radiology-related nonstandard codes are rolled up to standard line 76, ‘‘Other Ancillary’’, and 2 Ibid. PO 00000 Frm 00023 Fmt 4701 Sfmt 4702 24345 not to standard lines 54 (Radiology— Diagnostic), 55 (Radiology— Therapeutic), and 56 (Radioisotope) as under CMS’ usual practice, the Radiology CCR would be 0.161. Most notably, the CCR that is most impacted is the ‘‘Other Services’’ CCR. Currently, as proposed in section II.H.3. of the preamble of this proposed rule, the ‘‘Other Services’’ CCR is 0.367. However, if all nonstandard cost center codes would remain 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 would be 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.’’ 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). Some questions that arise are whether CMS’ procedures for mapping and rolling up nonstandard cost centers to specific standard cost centers should be updated or whether hospital reporting practices are imprecise, or whether there is a combination of both. 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 5digit codes 03020 through 03029 to standard cost center line 53, ‘‘Anesthesiology.’’ However, determining which other standard line E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 24346 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules ‘‘Acupuncture’’ and its associated 5digit codes 03020 through 03029 should be mapped 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 then 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 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, we are interested in receiving public comments from stakeholders as to how to improve the use of nonstandard cost center codes. 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 softwares ‘‘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’’). Some flexibility could be maintained, but within certain limits, in consideration of unique services that hospitals might provide. In the interim, while we seek public comments on this issue, we have proposed 19 CCRs for FY 2016 (listed in section II.H.3. of the preamble of this proposed rule) that were calculated from the December 31, 2014 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 proposed 19 CCRs on the FY 2016 IPPS Proposed Rule Home Page at: https:// www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/ AcuteInpatientPPS/FY2016-IPPSProposed-Rule-Home-Page.html.3 F. Proposed 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 evidencebased 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. 3 Ibid. VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00024 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 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 11 current categories of HACs is included on the CMS Web site at: https://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 proposed 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: https:// www.cms.gov/manuals/downloads/ Pub100_20.pdf. The current POA indicators and their descriptors are shown in the chart below: Indicator Descriptor Y .................... W ................... Indicates that the condition was present on admission. 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. Indicates that the condition was not present on admission. Indicates that the documentation is insufficient to determine if the condition was present at the time of admission. N ................... U ................... VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00025 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 EP30AP15.000</GPH> tkelley on DSK3SPTVN1PROD with PROPOSALS2 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 24347 24348 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules tkelley on DSK3SPTVN1PROD with PROPOSALS2 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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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: https://www.cms.gov/Medicare/Coding/ ICD10/ICD-10-MS-DRG-ConversionProject.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: https://www.cms.gov/ICD10/. Lastly, we provided information regarding the ICD–10 MS–DRG Conversion Project on the CMS Web site at: https:// www.cms.gov/Medicare/Medicare-Feefor-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: https://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: https:// www.cdc.gov/nchs/icd/icd10cm.htm. However, prior to engaging in rulemaking for the FY 2015 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: https://www.gpo.gov/fdsys/pkg/FR-201408-04/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 of the ICD–10 rules can be found on the Web site at: https:// www.cms.gov/Medicare/Coding/ICD10/ Statute_Regulations.html. As described in section II.F.5. of the preamble of this proposed rule, we are proposing the HAC list translation from ICD–9–CM to ICD–10–CM/ICD–10–PCS in this FY 2016 IPPS/LTCH PPS proposed rule. PO 00000 Frm 00026 Fmt 4701 Sfmt 4702 5. Proposed Changes to the HAC Program for FY 2016 As discussed in section II.G. 1. a. of the preamble of this proposed rule, for FY 2016, we are proposing 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 are proposing that the ICD–10–CM/PCS Version 33 HAC list replace the ICD–9– CM Version 32 HAC list. We are soliciting public comments on how well the ICD–10–CM/PCS Version 32 HAC list replicates 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: https://www.cms.hhs.gov/Medicare/ Coding/ICD10/ICD-10-MS-DRGConversion-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. With respect to the current categories of the HACs, we are not proposing to add or remove any categories in this FY 2016 IPPS/LTCH PPS proposed rule. However, as described more fully in section III.F.7, of the preamble of this proposed 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. We also continue to encourage public dialogue about refinements to the HAC list through written stakeholder comments. We 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 also 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 E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules tkelley on DSK3SPTVN1PROD with PROPOSALS2 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. In summary, we are proposing that the ICD–10–CM/PCS Version 33 HAC list replace the ICD–9–CM Version 32 HAC list and are seeking public comments on how well the ICD–10–CM/ PCS Version 32 HAC list replicates the ICD–9–CM Version 32 HAC list. 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 MedPAR 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: https://www.cms.gov/ HospitalAcqCond/01_Overview.asp and the RTI Web site at: https://www.rti.org/ reports/cms/. In addition to the evaluation of HAC and POA MedPAR 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: https://www.cms.gov/Medicare/ Medicare-Fee-for-Service-Payment/ HospitalAcqCond/. 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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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: https://www.cms.gov/ Medicare/Medicare-Fee-for-ServicePayment/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 2014 report and made it available to the public on the CMS Hospital-Acquired Conditions Web page in the ‘‘Downloads’’ section at: https://www.cms.gov/Medicare/ Medicare-Fee-for-Service-Payment/ HospitalAcqCond/?redirect=/ HospitalAcqCond/. Once we receive RTI’s 2015 report in the late spring or early summer, we will make it available to the public at this same link as the 2014 report. G. Proposed Changes to Specific MS– DRG Classifications 1. Discussion of Changes to Coding System and Basis for MS–DRG Updates a. 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 PO 00000 Frm 00027 Fmt 4701 Sfmt 4702 24349 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 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: https:// 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: https://www.gpo.gov/fdsys/pkg/FR-201408-04/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 E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 24350 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 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: https:// www.cms.hhs.gov/Medicare/Coding/ ICD10/ICD-10-MS-DRG-ConversionProject.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: https://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: https://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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 (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 PO 00000 Frm 00028 Fmt 4701 Sfmt 4702 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. 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: https:// 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: https:// www.cms.gov/Medicare/Coding/ICD10/ ICD-10-MS-DRG-ConversionProject.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: https:// www.cms.gov/Medicare/Coding/ ICD9ProviderDiagnosticCodes/ICD-9CM-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 E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules Definitions Manual of the ICD–10 MS– DRGs Version 31 on the ICD–10 MS– DRG Conversion Project Web site at: https://www.cms.gov/Medicare/Coding/ ICD10/ICD-10-MS-DRG-ConversionProject.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: https://www.cms.gov/Medicare/Coding/ ICD10/ICD-10-MS-DRG-ConversionProject.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: https:// www.cms.gov/Medicare/Coding/ICD10/ ICD-10-MS-DRG-ConversionProject.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: https://www.cms.gov/Medicare/Coding/ ICD10/ICD-10-MS-DRG-ConversionProject.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: https://www.cms.gov/Medicare/ Coding/ICD10/ICD-10-MS-DRGConversion-Project.html under the ‘‘Related Links’’ section. This ICD–10 MS–DRGs Version 32 computer VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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 proposed rule. Therefore, we are proposing 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 this FY 2016 IPPS/LTCH PPS proposed rule, we are proposing 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 are inviting 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. b. Basis for Proposed 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 FY 2016 are discussed below in this section. Following are the changes we are proposing to the MS–DRGs for FY 2016. We are inviting public comment 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 are proposing changes to the MS–DRG classifications based on our analysis of claims data. In other cases, we are proposing to maintain the existing MS– DRG classification based on our analysis of claims data. For this FY 2016 proposed rule, our MS–DRG analysis is 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 proposed MS–DRG reclassification changes that follows, we refer to our analysis of claims data from PO 00000 Frm 00029 Fmt 4701 Sfmt 4702 24351 the ‘‘December 2014 update of the FY 2014 MedPAR file.’’ As explained in previous rulemaking (76 FR 51487), in deciding whether to propose 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. Further, 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 E:\FR\FM\30APP2.SGM 30APP2 24352 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 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 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 great, reflecting, for instance, the use of an operating suite versus interventional vascular catheterization lab 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 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: tkelley on DSK3SPTVN1PROD with PROPOSALS2 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 03LG3BZ ...................... 03LG3DZ ...................... 03LG4BZ ...................... 03LG4DZ ...................... 03LH3BZ ....................... 03LH3DZ ...................... 03LH4BZ ....................... 03LH4DZ ...................... VerDate Sep<11>2014 Code description Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion 18:20 Apr 29, 2015 of of of of of of of of intracranial artery with bioactive intraluminal device, percutaneous approach. intracranial artery with intraluminal device, percutaneous approach. intracranial artery with bioactive intraluminal device, percutaneous endoscopic approach. intracranial artery with intraluminal device, percutaneous endoscopic approach. right common carotid artery with bioactive intraluminal device, percutaneous approach. right common carotid artery with intraluminal device, percutaneous approach. right common carotid artery with bioactive intraluminal device, percutaneous endoscopic approach. right common carotid artery with intraluminal device, percutaneous endoscopic approach. Jkt 235001 PO 00000 Frm 00030 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 24353 ICD–10–PCS CODES FOR ENDOVASCULAR EMBOLIZATION ASSIGNED TO MS–DRGS 020 THROUGH 027 IN ICD–10 MS– DRGS VERSION 32—Continued tkelley on DSK3SPTVN1PROD with PROPOSALS2 ICD–10–PCS code 03LJ3BZ ....................... 03LJ3DZ ....................... 03LJ4BZ ....................... 03LJ4DZ ....................... 03LK3BZ ....................... 03LK3DZ ....................... 03LK4BZ ....................... 03LK4DZ ....................... 03LL3BZ ....................... 03LL3DZ ....................... 03LL4BZ ....................... 03LL4DZ ....................... 03LM3BZ ...................... 03LM3DZ ...................... 03LM4BZ ...................... 03LM4DZ ...................... 03LN3BZ ....................... 03LN3DZ ...................... 03LN4BZ ....................... 03LN4DZ ...................... 03LP3BZ ....................... 03LP3DZ ....................... 03LP4BZ ....................... 03LP4DZ ....................... 03LQ3BZ ...................... 03LQ3DZ ...................... 03LQ4BZ ...................... 03LQ4DZ ...................... 03LR3DZ ...................... 03LR4DZ ...................... 03LS3DZ ....................... 03LS4DZ ....................... 03LT3DZ ....................... 03LT4DZ ....................... 03VG3BZ ...................... 03VG3DZ ...................... 03VG4BZ ...................... 03VG4DZ ...................... 03VH3BZ ...................... 03VH3DZ ...................... 03VH4BZ ...................... 03VH4DZ ...................... 03VJ3BZ ....................... 03VJ3DZ ....................... 03VJ4BZ ....................... 03VJ4DZ ....................... 03VK3BZ ...................... 03VK3DZ ...................... 03VK4BZ ...................... 03VK4DZ ...................... 03VL3BZ ....................... 03VL3DZ ....................... 03VL4BZ ....................... 03VL4DZ ....................... 03VM3BZ ...................... 03VM3DZ ...................... 03VM4BZ ...................... 03VM4DZ ...................... 03VN3BZ ...................... 03VN3DZ ...................... 03VN4BZ ...................... 03VN4DZ ...................... 03VP3BZ ...................... 03VP3DZ ...................... 03VP4BZ ...................... 03VP4DZ ...................... 03VQ3BZ ...................... 03VQ3DZ ...................... 03VQ4BZ ...................... 03VQ4DZ ...................... 03VR3DZ ...................... VerDate Sep<11>2014 Code description Occlusion of left common carotid artery with bioactive intraluminal device, percutaneous approach. Occlusion of left common carotid artery with intraluminal device, percutaneous approach. Occlusion of left common carotid artery with bioactive intraluminal device, percutaneous endoscopic approach. Occlusion of left common carotid artery with intraluminal device, percutaneous endoscopic approach. Occlusion of right internal carotid artery with bioactive intraluminal device, percutaneous approach. Occlusion of right internal carotid artery with intraluminal device, percutaneous approach. Occlusion of right internal carotid artery with bioactive intraluminal device, percutaneous endoscopic approach. Occlusion of right internal carotid artery with intraluminal device, percutaneous endoscopic approach. Occlusion of left internal carotid artery with bioactive intraluminal device, percutaneous approach. Occlusion of left internal carotid artery with intraluminal device, percutaneous approach. Occlusion of left internal carotid artery with bioactive intraluminal device, percutaneous endoscopic approach. Occlusion of left internal carotid artery with intraluminal device, percutaneous endoscopic approach. Occlusion of right external carotid artery with bioactive intraluminal device, percutaneous approach. Occlusion of right external carotid artery with intraluminal device, percutaneous approach. Occlusion of right external carotid artery with bioactive intraluminal device, percutaneous endoscopic approach. Occlusion of right external carotid artery with intraluminal device, percutaneous endoscopic approach. Occlusion of left external carotid artery with bioactive intraluminal device, percutaneous approach. Occlusion of left external carotid artery with intraluminal device, percutaneous approach. Occlusion of left external carotid artery with bioactive intraluminal device, percutaneous endoscopic approach. Occlusion of left external carotid artery with intraluminal device, percutaneous endoscopic approach. Occlusion of right vertebral artery with bioactive intraluminal device, percutaneous approach. Occlusion of right vertebral artery with intraluminal device, percutaneous approach. Occlusion of right vertebral artery with bioactive intraluminal device, percutaneous endoscopic approach. Occlusion of right vertebral artery with intraluminal device, percutaneous endoscopic approach. Occlusion of left vertebral artery with bioactive intraluminal device, percutaneous approach. Occlusion of left vertebral artery with intraluminal device, percutaneous approach. Occlusion of left vertebral artery with bioactive intraluminal device, percutaneous endoscopic approach. Occlusion of left vertebral artery with intraluminal device, percutaneous endoscopic approach. Occlusion of face artery with intraluminal device, percutaneous approach. Occlusion of face artery with intraluminal device, percutaneous endoscopic approach. Occlusion of right temporal artery with intraluminal device, percutaneous approach. Occlusion of right temporal artery with intraluminal device, percutaneous endoscopic approach. Occlusion of left temporal artery with intraluminal device, percutaneous approach. Occlusion of left temporal artery with intraluminal device, percutaneous endoscopic approach. Restriction of intracranial artery with bioactive intraluminal device, percutaneous approach. Restriction of intracranial artery with intraluminal device, percutaneous approach. Restriction of intracranial artery with bioactive intraluminal device, percutaneous endoscopic approach. Restriction of intracranial artery with intraluminal device, percutaneous endoscopic approach. Restriction of right common carotid artery with bioactive intraluminal device, percutaneous approach. Restriction of right common carotid artery with intraluminal device, percutaneous approach. Restriction of right common carotid artery with bioactive intraluminal device, percutaneous endoscopic approach. Restriction of right common carotid artery with intraluminal device, percutaneous endoscopic approach. Restriction of left common carotid artery with bioactive intraluminal device, percutaneous approach. Restriction of left common carotid artery with intraluminal device, percutaneous approach. Restriction of left common carotid artery with bioactive intraluminal device, percutaneous endoscopic approach. Restriction of left common carotid artery with intraluminal device, percutaneous endoscopic approach. Restriction of right internal carotid artery with bioactive intraluminal device, percutaneous approach. Restriction of right internal carotid artery with intraluminal device, percutaneous approach. Restriction of right internal carotid artery with bioactive intraluminal device, percutaneous endoscopic approach. Restriction of right internal carotid artery with intraluminal device, percutaneous endoscopic approach. Restriction of left internal carotid artery with bioactive intraluminal device, percutaneous approach. Restriction of left internal carotid artery with intraluminal device, percutaneous approach. Restriction of left internal carotid artery with bioactive intraluminal device, percutaneous endoscopic approach. Restriction of left internal carotid artery with intraluminal device, percutaneous endoscopic approach. Restriction of right external carotid artery with bioactive intraluminal device, percutaneous approach. Restriction of right external carotid artery with intraluminal device, percutaneous approach. Restriction of right external carotid artery with bioactive intraluminal device, percutaneous endoscopic approach. Restriction of right external carotid artery with intraluminal device, percutaneous endoscopic approach. Restriction of left external carotid artery with bioactive intraluminal device, percutaneous approach. Restriction of left external carotid artery with intraluminal device, percutaneous approach. Restriction of left external carotid artery with bioactive intraluminal device, percutaneous endoscopic approach. Restriction of left external carotid artery with intraluminal device, percutaneous endoscopic approach. Restriction of right vertebral artery with bioactive intraluminal device, percutaneous approach. Restriction of right vertebral artery with intraluminal device, percutaneous approach. Restriction of right vertebral artery with bioactive intraluminal device, percutaneous endoscopic approach. Restriction of right vertebral artery with intraluminal device, percutaneous endoscopic approach. Restriction of left vertebral artery with bioactive intraluminal device, percutaneous approach. Restriction of left vertebral artery with intraluminal device, percutaneous approach. Restriction of left vertebral artery with bioactive intraluminal device, percutaneous endoscopic approach. Restriction of left vertebral artery with intraluminal device, percutaneous endoscopic approach. Restriction of face artery with intraluminal device, percutaneous approach. 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00031 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 24354 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules ICD–10–PCS CODES FOR ENDOVASCULAR EMBOLIZATION ASSIGNED TO MS–DRGS 020 THROUGH 027 IN ICD–10 MS– DRGS VERSION 32—Continued ICD–10–PCS code 03VR4DZ 03VS3DZ 03VS4DZ 03VT3DZ 03VT4DZ 03VU3DZ 03VU4DZ 03VV3DZ 03VV4DZ ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... Code description Restriction Restriction Restriction Restriction Restriction Restriction Restriction Restriction Restriction of of of of of of of of of face artery with intraluminal device, percutaneous endoscopic approach. right temporal artery with intraluminal device, percutaneous approach. right temporal artery with intraluminal device, percutaneous endoscopic approach. left temporal artery with intraluminal device, percutaneous approach. left temporal artery with intraluminal device, percutaneous endoscopic approach. right thyroid artery with intraluminal device, percutaneous approach. right thyroid artery with intraluminal device, percutaneous endoscopic approach. left thyroid artery with intraluminal device, percutaneous approach. left thyroid artery with intraluminal device, percutaneous endoscopic approach. For this FY 2016 IPPS/LTCH PPS proposed rule request, we first examined claims data on all intracranial vascular procedure cases with a principal diagnosis of hemorrhage reported in MS–DRGs 020, 021, and 022 from 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 cases MS–DRG MS–DRG 020 (with MCC)—All cases ......................................................................................... MS–DRG 021 (with CC)—All cases ............................................................................................ MS–DRG 022 (without CC/MCC)—All cases .............................................................................. 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 reported in MS–DRGs 020, 021, and 022. Our findings for the first part of this multi- 1,285 372 98 Average length of stay Average costs 16.84 13.82 8.28 $71,655 52,143 36,998 part request are shown in the table below. ENDOVASCULAR INTRACRANIAL EMBOLIZATION PROCEDURES WITH PRINCIPAL DIAGNOSIS OF HEMORRHAGE Number of cases Average length of stay Average costs Requested New Combined MS–DRG ......................................................................................... tkelley on DSK3SPTVN1PROD with PROPOSALS2 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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 highest severity level (MS–DRG 020, which had average costs of $71,655) would be reduced. We believe that maintaining the current MS–DRG assignment for these types of procedures is appropriate. Our clinical advisors state 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 are not proposing 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 are inviting public comments on this proposal. As discussed previously, the requestor also recommended the creation of a new set of MS–DRGs for PO 00000 Frm 00032 Fmt 4701 Sfmt 4702 endovascular intracranial embolization procedures without a principal diagnosis of hemorrhage with MCC, with CC, and without CC/MCC. For these new requested 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); E:\FR\FM\30APP2.SGM 30APP2 24355 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules • 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 cases MS–DRG tkelley on DSK3SPTVN1PROD with PROPOSALS2 MS–DRG 023—All cases ............................................................................................................ MS–DRG 023—Cases with endovascular intracranial procedure without diagnosis of hemorrhage ........................................................................................................................................ MS–DRG 024—All cases ............................................................................................................ MS–DRG 024—Cases with endovascular intracranial procedure without diagnosis of hemorrhage ........................................................................................................................................ MS–DRG 025—All cases ............................................................................................................ MS–DRG 025—Cases with endovascular intracranial procedure without diagnosis of hemorrhage ........................................................................................................................................ MS–DRG 026—All cases ............................................................................................................ MS–DRG 026—Cases with endovascular intracranial procedure without diagnosis of hemorrhage ........................................................................................................................................ MS–DRG 027—All cases ............................................................................................................ MS–DRG 027—Cases with endovascular intracranial procedure 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. 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 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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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. We have 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 PO 00000 Frm 00033 Fmt 4701 Sfmt 4702 Average length of stay Average costs 5,615 10.96 $37,784 1,510 1,848 8.88 5.93 39,666 26,195 867 16,949 5.80 9.35 27,975 29,970 650 8,075 8.52 6.09 44,082 21,414 778 9,883 3.07 3.15 26,594 16,613 1,793 1.66 22,244 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 a endovascular intracranial procedure without a diagnosis of hemorrhage than for all cases in MS–DRG 027, the length of stay is shorter. We have 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 are not proposing 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 do 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 E:\FR\FM\30APP2.SGM 30APP2 24356 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 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, we are not proposing to create the four new MS– DRGs for endovascular intracranial embolization and other endovascular procedures recommended by the requestor. We are proposing to maintain the current MS–DRG structure for MS– DRGs 020 through 027. We are inviting public comments on these two proposals. tkelley on DSK3SPTVN1PROD with PROPOSALS2 3. MDC 5 (Diseases and Disorders of the Circulatory System) a. 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 DrugEluting Stent with MCC or 4+ Vessels/ Stents); MS–DRG 247 (Percutaneous Cardiovascular Procedure with DrugEluting 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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 comment for possible proposals in future rulemaking as part of our annual review process. For this FY 2016 IPPS/LTCH PPS proposed rule, we received a separate, but related, request involving most of these same MS–DRGs. Therefore, for this 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. b. 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 DrugEluting Stent with MCC or 4+ Vessels/ Stents); • MS–DRG 247 (Percutaneous Cardiovascular Procedure with DrugEluting Stent without MCC); • MS–DRG 248 (Percutaneous Cardiovascular Procedure with NonDrug-Eluting Stent with MCC or 4+ Vessels/Stents); • MS–DRG 249 (Percutaneous Cardiovascular Procedure with NonDrug-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 PO 00000 Frm 00034 Fmt 4701 Sfmt 4702 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. E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 24357 ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 35.52 ICD–10–PCS code 02U53JZ ....................... 02U54JZ ....................... Code description Supplement atrial septum with synthetic substitute, percutaneous approach. Supplement atrial septum with synthetic substitute, percutaneous endoscopic approach. 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 027F34Z ....................... 027F3DZ ....................... 027F3ZZ ....................... 027F44Z ....................... 027F4DZ ....................... 027F4ZZ ....................... 027G34Z ....................... 027G3DZ ...................... 027G3ZZ ....................... 027G44Z ....................... 027G4DZ ...................... 027G4ZZ ....................... 027H34Z ....................... 027H3DZ ...................... 027H3ZZ ....................... 027H44Z ....................... 027H4DZ ...................... 027H4ZZ ....................... 027J34Z ........................ 027J3DZ ....................... 027J3ZZ ........................ 027J44Z ........................ 027J4DZ ....................... 027J4ZZ ........................ Code description Dilation Dilation Dilation Dilation Dilation Dilation Dilation Dilation Dilation Dilation Dilation Dilation Dilation Dilation Dilation Dilation Dilation Dilation Dilation Dilation Dilation Dilation Dilation Dilation of of of of of of of of of of of of of of of of of of of of of of of of aortic valve with drug-eluting intraluminal device, percutaneous approach. aortic valve with intraluminal device, percutaneous approach. aortic valve, percutaneous approach. aortic valve with drug-eluting intraluminal device, percutaneous endoscopic approach. aortic valve with intraluminal device, percutaneous endoscopic approach. aortic valve, percutaneous endoscopic approach. mitral valve with drug-eluting intraluminal device, percutaneous approach. mitral valve with intraluminal device, percutaneous approach. mitral valve, percutaneous approach. mitral valve with drug-eluting intraluminal device, percutaneous endoscopic approach. mitral valve with intraluminal device, percutaneous endoscopic approach. mitral valve, percutaneous endoscopic approach. pulmonary valve with drug-eluting intraluminal device, percutaneous approach. pulmonary valve with intraluminal device, percutaneous approach. pulmonary valve, percutaneous approach. pulmonary valve with drug-eluting intraluminal device, percutaneous endoscopic approach. pulmonary valve with intraluminal device, percutaneous endoscopic approach. pulmonary valve, percutaneous endoscopic approach. tricuspid valve with drug-eluting intraluminal device, percutaneous approach. tricuspid valve with intraluminal device, percutaneous approach. tricuspid valve, percutaneous approach. tricuspid valve with drug-eluting intraluminal device, percutaneous endoscopic approach. tricuspid valve with intraluminal device, percutaneous endoscopic approach. 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 02K83ZZ ....................... 02K84ZZ ....................... Code description Map conduction mechanism, percutaneous approach. 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 tkelley on DSK3SPTVN1PROD with PROPOSALS2 ICD–10–PCS code 02553ZZ ....................... 02563ZZ ....................... 02573ZZ ....................... 02583ZZ ....................... 02593ZZ ....................... 025F3ZZ ....................... 025G3ZZ ....................... 025H3ZZ ....................... 025J3ZZ ........................ 025K3ZZ ....................... 025L3ZZ ....................... VerDate Sep<11>2014 Code description Destruction Destruction Destruction Destruction Destruction Destruction Destruction Destruction Destruction Destruction Destruction 18:20 Apr 29, 2015 of of of of of of of of of of of atrial septum, percutaneous approach. right atrium, percutaneous approach. left atrium, percutaneous approach. conduction mechanism, percutaneous approach. chordae tendineae, percutaneous approach. aortic valve, percutaneous approach. mitral valve, percutaneous approach. pulmonary valve, percutaneous approach. tricuspid valve, percutaneous approach. right ventricle, percutaneous approach. left ventricle, percutaneous approach. Jkt 235001 PO 00000 Frm 00035 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 24358 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 37.34—Continued ICD–10–PCS code 025M3ZZ ...................... 02B53ZZ ....................... 02B63ZZ ....................... 02B73ZZ ....................... 02B83ZZ ....................... 02B93ZZ ....................... 02BF3ZZ ....................... 02BG3ZZ ...................... 02BH3ZZ ...................... 02BJ3ZZ ....................... 02BM3ZZ ...................... 02T83ZZ ....................... Code description Destruction of ventricular septum, percutaneous approach. Excision of atrial septum, percutaneous approach. Excision of right atrium, percutaneous approach. Excision of left atrium, percutaneous approach. Excision of conduction mechanism, percutaneous approach. Excision of chordae tendineae, percutaneous approach. Excision of aortic valve, percutaneous approach. Excision of mitral valve, percutaneous approach. Excision of pulmonary valve, percutaneous approach. Excision of tricuspid valve, percutaneous approach. Excision of ventricular septum, percutaneous approach. 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 02573ZK 02574ZK 02B73ZK 02B74ZK 02L73ZK 02L74ZK ....................... ....................... ....................... ....................... ....................... ....................... Code description Destruction of left atrial appendage, percutaneous approach. Destruction of left atrial appendage, percutaneous endoscopic approach. Excision of left atrial appendage, percutaneous approach. Excision of left atrial appendage, percutaneous endoscopic approach. Occlusion of left atrial appendage, percutaneous approach. 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 02L73CK 02L73DK 02L74CK 02L74DK ....................... ....................... ....................... ....................... Code description Occlusion Occlusion Occlusion Occlusion of of of of left left left left atrial atrial atrial atrial 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: https://www.cms.gov/ appendage appendage appendage appendage with with with with extraluminal device, percutaneous approach. intraluminal device, percutaneous approach. extraluminal device, percutaneous endoscopic approach. intraluminal device, percutaneous endoscopic approach. Medicare/Coding/ICD10/ICD-10-MSDRG-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 cases tkelley on DSK3SPTVN1PROD with PROPOSALS2 MS–DRG MS–DRG 246—All cases ............................................................................................................ MS–DRG 246—Cases with procedure codes 35.52, 35.96, 35.97, 37.26, 37.27, 37.34, 37.36, and 37.90 ................................................................................................................................. MS–DRG 247—All cases ............................................................................................................ MS–DRG 247—Cases with procedure codes 35.52, 35.96, 35.97, 37.26, 37.27, 37.34, 37.36, and 37.90 ................................................................................................................................. MS–DRG 248—All cases ............................................................................................................ MS–DRG 248 –Cases with procedure codes 35.52, 35.96, 35.97, 37.26, 37.27, 37.34, 37.36, and 37.90 ................................................................................................................................. MS–DRG 249—All cases ............................................................................................................ MS–DRG 249—Cases with procedure codes 35.52, 35.96, 35.97, 37.26, 37.27, 37.34, 37.36, and 37.90 ................................................................................................................................. MS–DRG 250—All cases ............................................................................................................ VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00036 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM Average length of stay Average costs 30,617 5.52 $23,855 244 79,639 9.69 2.69 $34.099 $15,671 260 9,310 5.20 6.37 $25,797 $22,504 125 16,273 10.76 3.08 $33,521 $14,066 81 9,275 5.12 7.07 $23,710 $22,902 30APP2 24359 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules PERCUTANEOUS CARDIOVASCULAR MS–DRGS WITH AND WITHOUT STENTS—Continued Number of cases MS–DRG MS–DRG 250– Cases with procedure codes 35.52, 35.96, 35.97, 37.26, 37.27, 37.34, 37.36, and 37.90 ................................................................................................................................. MS–DRG 251—All cases ............................................................................................................ MS–DRG 251—Cases with procedure codes 35.52, 35.96, 35.97, 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. Average length of stay Average costs 5,826 20,945 7.90 3.25 $24,841 $15,757 14,436 3.39 $17,290 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 cases MS–DRG MS–DRGs 246 through 251—Cases with procedure codes 35.52, 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, 35.96, 35.97, 37.26, 37.27, 37.34, 37.36, and 37.90 ................................................................................................ 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 support 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 this 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 agree 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 are proposing to create two new MS– DRGs to classify percutaneous intracardiac procedures. Specifically, we are proposing to create MS–DRG 273, entitled ‘‘Percutaneous Intracardiac Procedures with MCC,’’ and MS–DRG Average length of stay Average costs 20,972 4.79 $19,810 145,087 3.62 17,532 274, 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 are proposing 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 cases tkelley on DSK3SPTVN1PROD with PROPOSALS2 MS–DRG Proposed MS–DRG 273 with MCC ............................................................................................. Proposed MS–DRG 274 without MCC ........................................................................................ We are inviting public comments on our proposal to create the two new MS– DRGs for percutaneous intracardiac procedures for FY 2016. In addition, we VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 are inviting public comments on the ICD–10–PCS code translations that were presented earlier in this section and our proposal to assign these procedure PO 00000 Frm 00037 Fmt 4701 Sfmt 4702 6,195 14,777 Average length of stay 8.03 3.44 Average costs $25,380 17,475 codes to the proposed new MS–DRGs 273 and 274. As mentioned earlier in this section, we received a similar request in E:\FR\FM\30APP2.SGM 30APP2 24360 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 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 Percutaneous cardiovascular MS–DRG with and without stent procedures by suggested severity level Suggested Suggested Suggested Suggested Suggested Suggested Suggested Suggested Suggested MS–DRG MS–DRG MS–DRG MS–DRG MS–DRG MS–DRG MS–DRG MS–DRG MS–DRG 246 246 246 248 248 248 250 250 250 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 this 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. Number of cases with MCC ........................................................................................... with CC .............................................................................................. without CC/MCC ................................................................................ with MCC ........................................................................................... with CC .............................................................................................. without CC/MCC ................................................................................ with MCC ........................................................................................... with CC .............................................................................................. without CC/MCC ................................................................................ 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, Average length of stay 30,617 45,313 34,326 9,310 9,510 6,763 9,275 11,653 9,292 5.52 2.96 2.33 6.37 3.49 2.51 7.07 3.80 2.56 Average costs $23,855 16,233 14,928 22,504 14,798 13,037 22,903 16,113 15,310 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 cases MS–DRG MS–DRG MS–DRG MS–DRG MS–DRG MS–DRG MS–DRG 246—All 247—All 248—All 249—All 250—All 251—All cases cases cases cases cases cases ............................................................................................................ ............................................................................................................ ............................................................................................................ ............................................................................................................ ............................................................................................................ ............................................................................................................ Therefore, we are not proposing to further subdivide the severity levels for MS–DRGs 246 through 251. We are inviting public comments on our proposal not to create additional severity levels for MS–DRGs 246 through 251. 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 Average length of stay 30,617 79,639 9,310 16,273 9,275 20,945 5.52 2.69 6.37 3.08 7.07 3.25 Average costs $23,855 15,671 22,504 14,066 22,903 15,757 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 Number of cases Average length of stay Average costs MS–DRG 245—All cases ............................................................................................................ tkelley on DSK3SPTVN1PROD with PROPOSALS2 MS–DRG 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 this proposed rule, to determine if it was appropriate to subdivide MS–DRG 245 into severity levels. The table below illustrates our findings. Number of cases AICD generator procedures by suggested severity level Suggested MS–DRG 245 with MCC ........................................................................................... VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00038 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 542 30APP2 Average length of stay 8.15 Average costs $40,004 24361 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules Number of cases AICD generator procedures by suggested severity level Suggested MS–DRG 245 with CC .............................................................................................. Suggested MS–DRG 245 without CC/MCC ................................................................................ Based on the analysis of the FY 2014 claims data for MS–DRG 245, the results support creating a ‘‘with MCC’’ and a ‘‘without MCC’’ severity level split. 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 agree with our clinical advisors and note 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 Average length of stay 939 218 4.51 3.12 Average costs 32,237 28,907 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 MS–DRG Number of cases Average length of stay Average costs MS–DRG 245—All cases ............................................................................................................ 1,850 4.81 $33,272 The FY 2013 claims data for MS–DRG 245 do 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 3way 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 cases MS–DRG by suggested severity level tkelley on DSK3SPTVN1PROD with PROPOSALS2 MS–DRG 245 with MCC ............................................................................................................. MS–DRG 245 with CC ................................................................................................................ MS–DRG 245 without CC/MCC .................................................................................................. 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 severity levels for MS–DRG 245. Our clinical advisors also agree 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 are not proposing to add severity levels for MS– DRG 245 for FY 2016. We are inviting public comments on the results of our analysis and our proposal not to create severity levels for MS–DRG 245. VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 c. Zilver® PTX Drug-Eluting Peripheral Stent (Zilver® PTX®) Zilver® PTX Drug-Eluting Peripheral Stent (Zilver® PTX®) was approved for new technology add-on payments in FY 2014 (78 FR 50583 through 50585). Cases involving the Zilver® PTX® that are eligible for new technology add-on payments are identified by ICD–9–CM procedure code 00.60 (Insertion of drugeluting stent(s) of superficial femoral artery). We received a request from the manufacturer for an extension of new technology add-on payments for Zilver® PTX® 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 PO 00000 Frm 00039 Fmt 4701 Sfmt 4702 44 1,118 288 Average length of stay 7.32 4.26 3.10 Average costs $39,536 31,786 29,383 to extend the new technology add-on payment is addressed in section II.I.3.e. of the preamble of this proposed rule. The second option was to establish a new family of MS–DRGs for drugeluting stents used in the peripheral (noncoronary) vasculature. The third option was to assign all Zilver® PTX® 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); E:\FR\FM\30APP2.SGM 30APP2 24362 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules • 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 the drug-eluting peripheral stent procedures cases 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 cases MS–DRGs tkelley on DSK3SPTVN1PROD with PROPOSALS2 MS–DRG MS–DRG MS–DRG MS–DRG MS–DRG MS–DRG 252—All cases ............................................................................................................ 252—Cases with procedure code 00.60 .................................................................... 253—All cases ............................................................................................................ 253—Cases with procedure code 00.60 .................................................................... 254—All cases ............................................................................................................ 254—Cases with procedure code 00.60 .................................................................... Our findings show 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 drugeluting stent cases in MS–DRG 254 ($21,461) were lower than the average costs for all cases in MS–DRG 252 ($23,935). We have determined that the small number of cases (601) does 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 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, 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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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, we are not proposing to make any MS–DRG updates for peripheral angioplasty cases with a drug-eluting stent. We are proposing to maintain the current MS–DRG assignments for these cases in MS–DRGs 252, 253, and 254. We are inviting public comments on our proposal. d. 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 assign 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 DrugEluting Stent with MCC or 4+ Vessels/ Stents); PO 00000 Frm 00040 Fmt 4701 Sfmt 4702 30,696 133 34,746 353 15,394 115 Average length of stay Average costs 7.89 9.08 5.68 4.99 2.99 2.62 $23,935 32,623 19,030 25,396 12,629 21,461 • MS DRG 247 (Percutaneous Cardiovascular Procedure with DrugEluting Stent without MCC); • MS–DRG 248 (Percutaneous Cardiovascular Procedure with NonDrug-Eluting Stent with MCC or 4+ Vessels/Stents); • MS DRG 249 (Percutaneous Cardiovascular Procedure with NonDrug-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, for the proposed FY 2016 ICD–10 MS– DRGs Version 33, we are proposing to assign ICD–10–PCS procedure code 02UG3JZ to MS–DRGs 231 and 232 and MS–DRGs 246 through 251. We are inviting public comments on this proposal. e. Major Cardiovascular Procedures: Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Graft The new technology add-on payment for the Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Graft (Zenith® F. Graft) will end on September 30, 2015. Cases involving the Zenith® 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 Zenith® F. Graft, we refer readers to the E:\FR\FM\30APP2.SGM 30APP2 24363 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules FY 2015 IPPS/LTCH PPS final rule (79 FR 49921 through 49922). We received a request to reassign 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 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 04U03JZ 04U04JZ 04V03DZ 04V04DZ ....................... ....................... ....................... ....................... Code description Supplement abdominal aorta with synthetic substitute, percutaneous approach. Supplement abdominal aorta with synthetic substitute, percutaneous endoscopic approach. Restriction of abdominal aorta with intraluminal device, percutaneous approach. 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 04793DZ 04794DZ 047A3DZ 047A4DZ 04753DZ 04754DZ 04V03DZ 04V04DZ ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... Code description Dilation of right renal artery with intraluminal device, percutaneous approach. Dilation of right renal artery with intraluminal device, percutaneous endoscopic approach. Dilation of left renal artery with intraluminal device, percutaneous approach. Dilation of left renal artery with intraluminal device, percutaneous endoscopic approach. Dilation of superior mesenteric artery with intraluminal device, percutaneous approach. Dilation of superior mesenteric artery with intraluminal device, percutaneous endoscopic approach. Restriction of abdominal aorta with intraluminal device, percutaneous approach. Restriction of abdominal aorta with intraluminal device, percutaneous endoscopic approach. We analyzed claims data reporting 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 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 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 cases MS–DRG tkelley on DSK3SPTVN1PROD with PROPOSALS2 MS–DRG MS–DRG MS–DRG MS–DRG 237—All cases ............................................................................................................ 237—Cases with procedure code 39.78 .................................................................... 238—All cases ............................................................................................................ 238—Cases with procedure code 39.78 .................................................................... 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 ($3l,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 also note 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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 length of stay for all cases in MS–DRG 237 of 9.46 days. Our clinical advisors do 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 Zenith® 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 point 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, PO 00000 Frm 00041 Fmt 4701 Sfmt 4702 18,340 332 32,227 1,927 Average length of stay 9.46 8.46 3.72 2.52 Average costs $36,355 51,397 25,087 31,739 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 are not proposing to reassign all cases reporting procedure code 39.78 from MS–DRG 238 to MS– DRG 237, as the commenter requested. However, we recognize that the results of the data analysis also demonstrated that the average costs for cases reporting 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 E:\FR\FM\30APP2.SGM 30APP2 24364 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules higher average costs could be attributable to the cost of the device, we note the commenter’s concern that the end of the new technology add-on payment for Zenith® 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 Zenith® 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 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 cases MS–DRG MS–DRG MS–DRG MS–DRG MS–DRG 237—All cases ............................................................................................................ 237—Cases with procedure codes 39.71 and 39.78 ................................................. 238—All cases ............................................................................................................ 238—Cases with procedure codes 39.71 and 39.78 ................................................. As shown in the table above, the average costs for 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 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 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 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); Average length of stay 18,340 2,425 32,227 16,502 9.46 8.34 3.72 2.27 Average costs $36,355 47,363 25,087 28,998 • 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– 9–CM procedure codes are shown in the following table: tkelley on DSK3SPTVN1PROD with PROPOSALS2 ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 37.41 ICD–10–PCS code 02UA0JZ ....................... 02UA3JZ ....................... 02UA4JZ ....................... Code description Supplement heart with synthetic substitute, open approach. Supplement heart with synthetic substitute, percutaneous approach. Supplement heart with synthetic substitute, percutaneous endoscopic approach. For the ICD–9–CM codes that result in greater than 50 ICD–10–PCS comparable VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 code translations, we refer readers to Table 6P (ICD–10–PCS Code PO 00000 Frm 00042 Fmt 4701 Sfmt 4702 Translations for Proposed MS–DRG Changes) for this proposed rule (which E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules is available via the Internet on the CMS Web site at: https://www.cms.gov/ Medicare/Medicare-Fee-for-Service- Payment/AcuteInpatientPPS/ index.html. The table includes the MDC 24365 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 ICD–10–PCS code Code description The comparable ICD–10–PCS code translations for ICD–9–CM procedure code 37.49 are shown in Table 6P.1a that is available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/. ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 37.55 ICD–10–PCS code 02PA0QZ ...................... 02PA3QZ ...................... 02PA4QZ ...................... Code description Removal of implantable heart assist system from heart, open approach. Removal of implantable heart assist system from heart, percutaneous approach. 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 02PA0RZ ...................... 02PA3RZ ...................... 02PA4RZ ...................... Code description Removal of external heart assist system from heart, open approach. Removal of external heart assist system from heart, percutaneous approach. 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 02CW0ZZ ..................... 02CW3ZZ ..................... 02CW4ZZ ..................... 04C00ZZ ....................... 04C03ZZ ....................... 04C04ZZ ....................... Code description Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation of of of of of of matter matter matter matter matter matter from from from from from from thoracic aorta, open approach. thoracic aorta, percutaneous approach. thoracic aorta, percutaneous endoscopic approach. abdominal aorta, open approach. abdominal aorta, percutaneous approach. abdominal aorta, percutaneous endoscopic approach. ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.14 ICD–10–PCS code 02CW0ZZ ..................... 02CW3ZZ ..................... 02CW4ZZ ..................... 04C00ZZ ....................... 04C03ZZ ....................... 04C04ZZ ....................... Code description Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation of of of of of of matter matter matter matter matter matter from from from from from from thoracic aorta, open approach. thoracic aorta, percutaneous approach. thoracic aorta, percutaneous endoscopic approach. abdominal aorta, open approach. abdominal aorta, percutaneous approach. abdominal aorta, percutaneous endoscopic approach. ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.34 ICD–10–PCS code tkelley on DSK3SPTVN1PROD with PROPOSALS2 02BW0ZZ ...................... 02BW4ZZ ...................... 04B00ZZ ....................... 04B04ZZ ....................... Code description Excision Excision Excision Excision of of of of thoracic aorta, open approach. thoracic aorta, percutaneous endoscopic approach. abdominal aorta, open approach. abdominal aorta, percutaneous endoscopic approach. ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.44 ICD–10–PCS code 04R007Z ....................... 04R00JZ ....................... VerDate Sep<11>2014 Code description Replacement of abdominal aorta with autologous tissue substitute, open approach. Replacement of abdominal aorta with synthetic substitute, open approach. 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00043 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 24366 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.44—Continued ICD–10–PCS code 04R00KZ 04R047Z 04R04JZ 04R04KZ ....................... ....................... ....................... ....................... Code description Replacement Replacement Replacement Replacement of of of of abdominal abdominal abdominal abdominal aorta aorta aorta aorta with with with with nonautologous tissue substitute, open approach. autologous tissue substitute, percutaneous endoscopic approach. synthetic substitute, percutaneous endoscopic approach. nonautologous tissue substitute, percutaneous endoscopic approach. ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.64 ICD–10–PCS code 04500ZZ 04503ZZ 04504ZZ 04B00ZZ 04B03ZZ 04B04ZZ ....................... ....................... ....................... ....................... ....................... ....................... Code description Destruction of abdominal aorta, open approach. Destruction of abdominal aorta, percutaneous approach. Destruction of abdominal aorta, percutaneous endoscopic approach. Excision of abdominal aorta, open approach. Excision of abdominal aorta, percutaneous approach. Excision of abdominal aorta, percutaneous endoscopic approach. ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.84 ICD–10–PCS code 04L00CZ 04L00DZ 04L00ZZ 04L03CZ 04L03DZ 04L03ZZ 04L04CZ 04L04DZ 04L04ZZ ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... Code description Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion of of of of of of of of of abdominal abdominal abdominal abdominal abdominal abdominal abdominal abdominal abdominal aorta with extraluminal device, open approach. aorta with intraluminal device, open approach. aorta, open approach. aorta with extraluminal device, percutaneous approach. aorta with intraluminal device, percutaneous approach. aorta, percutaneous approach. aorta with extraluminal device, percutaneous endoscopic approach. aorta with intraluminal device, percutaneous endoscopic approach. aorta, percutaneous endoscopic approach. ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 39.24 tkelley on DSK3SPTVN1PROD with PROPOSALS2 ICD–10–PCS code 0410093 0410094 0410095 04100A3 04100A4 04100A5 04100J3 04100J4 04100J5 04100K3 04100K4 04100K5 04100Z3 04100Z4 04100Z5 0410493 0410494 0410495 04104A3 04104A4 04104A5 04104J3 04104J4 04104J5 04104K3 04104K4 04104K5 ........................ ........................ ........................ ....................... ....................... ....................... ........................ ........................ ........................ ....................... ....................... ....................... ........................ ........................ ........................ ........................ ........................ ........................ ....................... ....................... ....................... ........................ ........................ ........................ ....................... ....................... ....................... 04104Z3 ........................ 04104Z4 ........................ 04104Z5 ........................ VerDate Sep<11>2014 Code description Bypass abdominal aorta to right renal artery with autologous venous tissue, open approach. Bypass abdominal aorta to left renal artery with autologous venous tissue, open approach. Bypass abdominal aorta to bilateral renal artery with autologous venous tissue, open approach. Bypass abdominal aorta to right renal artery with autologous arterial tissue, open approach. Bypass abdominal aorta to left renal artery with autologous arterial tissue, open approach. Bypass abdominal aorta to bilateral renal artery with autologous arterial tissue, open approach. Bypass abdominal aorta to right renal artery with synthetic substitute, open approach. Bypass abdominal aorta to left renal artery with synthetic substitute, open approach. Bypass abdominal aorta to bilateral renal artery with synthetic substitute, open approach. Bypass abdominal aorta to right renal artery with nonautologous tissue substitute, open approach. Bypass abdominal aorta to left renal artery with nonautologous tissue substitute, open approach. Bypass abdominal aorta to bilateral renal artery with nonautologous tissue substitute, open approach. Bypass abdominal aorta to right renal artery, open approach. Bypass abdominal aorta to left renal artery, open approach. Bypass abdominal aorta to bilateral renal artery, open approach. Bypass abdominal aorta to right renal artery with autologous venous tissue, percutaneous endoscopic approach. Bypass abdominal aorta to left renal artery with autologous venous tissue, percutaneous endoscopic approach. Bypass abdominal aorta to bilateral renal artery with autologous venous tissue, percutaneous endoscopic approach. Bypass abdominal aorta to right renal artery with autologous arterial tissue, percutaneous endoscopic approach. Bypass abdominal aorta to left renal artery with autologous arterial tissue, percutaneous endoscopic approach. Bypass abdominal aorta to bilateral renal artery with autologous arterial tissue, percutaneous endoscopic approach. Bypass abdominal aorta to right renal artery with synthetic substitute, percutaneous endoscopic approach. Bypass abdominal aorta to left renal artery with synthetic substitute, percutaneous endoscopic approach. Bypass abdominal aorta to bilateral renal artery with synthetic substitute, percutaneous endoscopic approach. Bypass abdominal aorta to right renal artery with nonautologous tissue substitute, percutaneous endoscopic approach. Bypass abdominal aorta to left renal artery with nonautologous tissue substitute, percutaneous endoscopic approach. Bypass abdominal aorta to bilateral renal artery with nonautologous tissue substitute, percutaneous endoscopic approach. Bypass abdominal aorta to right renal artery, percutaneous endoscopic approach. Bypass abdominal aorta to left renal artery, percutaneous endoscopic approach. Bypass abdominal aorta to bilateral renal artery, percutaneous endoscopic approach. 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00044 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 24367 ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 39.71 ICD–10–PCS code 04U03JZ 04U04JZ 04V03DZ 04V04DZ ....................... ....................... ....................... ....................... Code description Supplement abdominal aorta with synthetic substitute, percutaneous approach. Supplement abdominal aorta with synthetic substitute, percutaneous endoscopic approach. Restriction of abdominal aorta with intraluminal device, percutaneous approach. 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 04793DZ 04794DZ 047A3DZ 047A4DZ 04753DZ 04754DZ 04U03JZ 04U04JZ 04V03DZ 04V04DZ ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... Code description Dilation of right renal artery with intraluminal device, percutaneous approach. Dilation of right renal artery with intraluminal device, percutaneous endoscopic approach. Dilation of left renal artery with intraluminal device, percutaneous approach. Dilation of left renal artery with intraluminal device, percutaneous endoscopic approach. Dilation of superior mesenteric artery with intraluminal device, percutaneous approach. Dilation of superior mesenteric artery with intraluminal device, percutaneous endoscopic approach. Supplement abdominal aorta with synthetic substitute, percutaneous approach. Supplement abdominal aorta with synthetic substitute, percutaneous endoscopic approach. Restriction of abdominal aorta with intraluminal device, percutaneous approach. 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 tkelley on DSK3SPTVN1PROD with PROPOSALS2 ICD–9–CM procedure code 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 ............................. VerDate Sep<11>2014 Code description Closed heart valvotomy, unspecified valve. Closed heart valvotomy, aortic valve. Closed heart valvotomy, mitral valve. Closed heart valvotomy, pulmonary valve. Closed heart valvotomy, tricuspid valve. Pericardiotomy. Biopsy of pericardium. Pericardiectomy. Implant of pulsation balloon. Implantation of cardiomyostimulation system. Open chest cardiac massage. Other operations on heart and pericardium. Incision of vessel, other thoracic vessels. Incision of vessel, abdominal arteries. Incision of vessel, abdominal veins. Endarterectomy, other thoracic vessels. Endarterectomy, abdominal arteries. Resection of vessel with anastomosis, other thoracic vessels. Resection of vessel with anastomosis, abdominal arteries. Resection of vessel with anastomosis, abdominal veins. Resection of vessel with replacement, abdominal arteries. Resection of vessel with replacement, abdominal veins. Ligation and stripping of varicose veins, other thoracic vessels. Other excision of vessels, thoracic vessels. Other excision of vessels, abdominal arteries. Other excision of vessels, abdominal veins. Other surgical occlusion of vessels, thoracic vessels. Other surgical occlusion of vessels, abdominal arteries. Other surgical occlusion of vessels, abdominal veins. Systemic to pulmonary artery shunt. Intra-abdominal venous shunt. Caval-pulmonary artery anastomosis. Aorta-subclavian-carotid bypass. Other intrathoracic vascular shunt or bypass. Aorta-iliac-femoral bypass. Other intra-abdominal vascular shunt or bypass. Other repair of aneurysm. Re-entry operation (aorta). Endovascular (total) embolization or occlusion of head and neck vessels. Endovascular embolization or occlusion of vessel(s) of head or neck using bare coils. 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00045 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 24368 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules ICD–9–CM PROCEDURE CODES THAT WERE DESIGNATED AS THE LESS COMPLEX, LESS INVASIVE PROCEDURES— Continued ICD–9–CM procedure code 39.76 ............................. 39.79 ............................. Code description Endovascular embolization or occlusion of vessel(s) of head or neck using bioactive coils. 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 code 02NF3ZZ ....................... 02NF4ZZ ....................... 02NG3ZZ ...................... 02NG4ZZ ...................... 02NH3ZZ ...................... 02NH4ZZ ...................... 02NJ3ZZ ....................... 02NJ4ZZ ....................... Code description Release Release Release Release Release Release Release Release aortic valve, percutaneous approach. aortic valve, percutaneous endoscopic approach. mitral valve, percutaneous approach. mitral valve, percutaneous endoscopic approach. pulmonary valve, percutaneous approach. pulmonary valve, percutaneous endoscopic approach. tricuspid valve, percutaneous approach. tricuspid valve, percutaneous endoscopic approach. ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 35.01 ICD–10–PCS code 02CF3ZZ 02CF4ZZ 02NF3ZZ 02NF4ZZ ....................... ....................... ....................... ....................... Code description Extirpation of matter from aortic valve, percutaneous approach. Extirpation of matter from aortic valve, percutaneous endoscopic approach. Release aortic valve, percutaneous approach. Release aortic valve, percutaneous endoscopic approach. ICD–10–PCS CODE TRANSLATION FOR ICD–9–CM PROCEDURE CODE 35.02 ICD–10–PCS code 02CG3ZZ 02CG4ZZ 02NG3ZZ 02NG4ZZ ...................... ...................... ...................... ...................... Code description Extirpation of matter from mitral valve, percutaneous approach. Extirpation of matter from mitral valve, percutaneous endoscopic approach. Release mitral valve, percutaneous approach. Release mitral valve, percutaneous endoscopic approach. ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 35.03 ICD–10–PCS code 02CH3ZZ 02CH4ZZ 02NH3ZZ 02NH4ZZ ...................... ...................... ...................... ...................... Code description Extirpation of matter from pulmonary valve, percutaneous approach. Extirpation of matter from pulmonary valve, percutaneous endoscopic approach. Release Pulmonary Valve, Percutaneous Approach. Release Pulmonary Valve, Percutaneous Endoscopic Approach. ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 35.04 tkelley on DSK3SPTVN1PROD with PROPOSALS2 ICD–10–PCS code 02CJ3ZZ 02CJ4ZZ 02NJ3ZZ 02NJ4ZZ ....................... ....................... ....................... ....................... Description Extirpation of matter from tricuspid valve, percutaneous approach. Extirpation of matter from tricuspid valve, percutaneous endoscopic approach. Release tricuspid valve, percutaneous approach. Release tricuspid valve, percutaneous endoscopic approach. ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 37.12 ICD–10–PCS code 02CN0ZZ ...................... 02CN3ZZ ...................... VerDate Sep<11>2014 Code description Extirpation of matter from pericardium, open approach. Extirpation of matter from pericardium, percutaneous approach. 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00046 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 37.12—Continued ICD–10–PCS code 02CN4ZZ ...................... 02HN00Z ...................... 02HN02Z ...................... 02HN30Z ...................... 02HN32Z ...................... 02HN40Z ...................... 02HN42Z ...................... 02NN0ZZ ...................... 02NN3ZZ ...................... 02NN4ZZ ...................... 0W9D00Z ...................... 0W9D0ZX ..................... 0W9D0ZZ ..................... 0WCD0ZZ ..................... 0WCD3ZZ ..................... 0WCD4ZZ ..................... 0WHD03Z ..................... 0WHD0YZ ..................... 0WHD33Z ..................... 0WHD3YZ ..................... 0WHD43Z ..................... 0WHD4YZ ..................... 0WPD00Z ..................... 0WPD01Z ..................... 0WPD03Z ..................... 0WPD0YZ ..................... 0WPD30Z ..................... 0WPD31Z ..................... 0WPD33Z ..................... 0WPD3YZ ..................... 0WPD40Z ..................... 0WPD41Z ..................... 0WPD43Z ..................... 0WPD4YZ ..................... 0WWD00Z .................... 0WWD01Z .................... 0WWD03Z .................... 0WWD0YZ .................... 0WWD30Z .................... 0WWD31Z .................... 0WWD33Z .................... 0WWD3YZ .................... 0WWD40Z .................... 0WWD41Z .................... 0WWD43Z .................... 0WWD4YZ .................... Code description Extirpation of matter from pericardium, percutaneous endoscopic approach. Insertion of pressure sensor monitoring device into pericardium, open approach. Insertion of monitoring device into pericardium, open approach. Insertion of pressure sensor monitoring device into pericardium, percutaneous approach. Insertion of monitoring device into pericardium, percutaneous approach. Insertion of pressure sensor monitoring device into pericardium, percutaneous endoscopic approach. Insertion of monitoring device into pericardium, percutaneous endoscopic approach. Release pericardium, open approach. Release pericardium, percutaneous approach. Release pericardium, percutaneous endoscopic approach. Drainage of pericardial cavity with drainage device, open approach. Drainage of pericardial cavity, open approach, diagnostic. Drainage of pericardial cavity, open approach. Extirpation of matter from pericardial cavity, open approach. Extirpation of matter from pericardial cavity, percutaneous approach. Extirpation of matter from pericardial cavity, percutaneous endoscopic approach. Insertion of infusion device into pericardial cavity, open approach. Insertion of other device into pericardial cavity, open approach. Insertion of infusion device into pericardial cavity, percutaneous approach. Insertion of other device into pericardial cavity, percutaneous approach. Insertion of infusion device into pericardial cavity, percutaneous endoscopic approach. Insertion of other device into pericardial cavity, percutaneous endoscopic approach. Removal of drainage device from pericardial cavity, open approach. Removal of radioactive element from pericardial cavity, open approach. Removal of infusion device from pericardial cavity, open approach. Removal of other device from pericardial cavity, open approach. Removal of drainage device from pericardial cavity, percutaneous approach. Removal of radioactive element from pericardial cavity, percutaneous approach. Removal of infusion device from pericardial cavity, percutaneous approach. Removal of other device from pericardial cavity, percutaneous approach. Removal of drainage device from pericardial cavity, percutaneous endoscopic approach. Removal of radioactive element from pericardial cavity, percutaneous endoscopic approach. Removal of infusion device from pericardial cavity, percutaneous endoscopic approach. Removal of other device from pericardial cavity, percutaneous endoscopic approach. Revision of drainage device in pericardial cavity, open approach. Revision of radioactive element in pericardial cavity, open approach. Revision of infusion device in pericardial cavity, open approach. Revision of other device in pericardial cavity, open approach. Revision of drainage device in pericardial cavity, percutaneous approach. Revision of radioactive element in pericardial cavity, percutaneous approach. Revision of infusion device in pericardial cavity, percutaneous approach. Revision of other device in pericardial cavity, percutaneous approach. Revision of drainage device in pericardial cavity, percutaneous endoscopic approach. Revision of radioactive element in pericardial cavity, percutaneous endoscopic approach. Revision of infusion device in pericardial cavity, percutaneous endoscopic approach. Revision of other device in pericardial cavity, percutaneous endoscopic approach. ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 37.24 ICD–10–PCS code 02BN0ZX ...................... 02BN3ZX ...................... 02BN4ZX ...................... Code description Excision of pericardium, open approach, diagnostic Excision of pericardium, percutaneous approach, diagnostic Excision of pericardium, percutaneous endoscopic approach, diagnostic ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 37.31 tkelley on DSK3SPTVN1PROD with PROPOSALS2 ICD–10–PCS code 025N0ZZ 025N3ZZ 025N4ZZ 02BN0ZZ 02BN3ZZ 02BN4ZZ 02TN0ZZ 02TN3ZZ 02TN4ZZ ....................... ....................... ....................... ...................... ...................... ...................... ....................... ....................... ....................... VerDate Sep<11>2014 Code description Destruction of pericardium, open approach. Destruction of pericardium, percutaneous approach. Destruction of pericardium, percutaneous endoscopic approach. Excision of pericardium, open approach. Excision of pericardium, percutaneous approach. Excision of pericardium, percutaneous endoscopic approach. Resection of pericardium, open approach. Resection of pericardium, percutaneous approach. Resection of pericardium, percutaneous endoscopic approach. 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00047 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 24369 24370 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 37.61 ICD–10–PCS code 5A02110 ....................... 5A02210 ....................... Code description Assistance with cardiac output using balloon pump, intermittent. 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 02QA0ZZ ...................... 02QA3ZZ ...................... 02QA4ZZ ...................... Code description Repair heart, open approach. Repair heart, percutaneous approach. Repair heart, percutaneous endoscopic approach. ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 37.91 ICD–10–PCS code 02QA0ZZ ...................... Code description Repair heart, open approach. ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 37.99 ICD–10–PCS code 02880ZZ ....................... 02883ZZ ....................... 02884ZZ ....................... Code description Division of conduction mechanism, open approach. Division of conduction mechanism, percutaneous approach. Division of conduction mechanism, percutaneous endoscopic approach. ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.05 ICD–10–PCS code Code description The comparable ICD–10–PCS code translations for ICD–9–CM procedure code 38.05 are shown in Table 6P.1b for this proposed rule, which is available via the Internet on the CMS Web site at: https://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 tkelley on DSK3SPTVN1PROD with PROPOSALS2 ICD–10–PCS code 04C10ZZ 04C13ZZ 04C14ZZ 04C20ZZ 04C23ZZ 04C24ZZ 04C30ZZ 04C33ZZ 04C34ZZ 04C40ZZ 04C43ZZ 04C44ZZ 04C50ZZ 04C53ZZ 04C54ZZ 04C60ZZ 04C63ZZ 04C64ZZ 04C70ZZ 04C73ZZ 04C74ZZ 04C80ZZ 04C83ZZ 04C84ZZ 04C90ZZ 04C93ZZ 04C94ZZ 04CA0ZZ 04CA3ZZ 04CA4ZZ ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ...................... ...................... ...................... VerDate Sep<11>2014 Code description Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation 18:20 Apr 29, 2015 of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter Jkt 235001 from from from from from from from from from from from from from from from from from from from from from from from from from from from from from from PO 00000 celiac artery, open approach. celiac artery, percutaneous approach. celiac artery, percutaneous endoscopic approach. gastric artery, open approach. gastric artery, percutaneous approach. gastric artery, percutaneous endoscopic approach. hepatic artery, open approach. hepatic artery, percutaneous approach. hepatic artery, percutaneous endoscopic approach. splenic artery, open approach. splenic artery, percutaneous approach. splenic artery, percutaneous endoscopic approach. superior mesenteric artery, open approach. superior mesenteric artery, percutaneous approach. superior mesenteric artery, percutaneous endoscopic approach. right colic artery, open approach. right colic artery, percutaneous approach. right colic artery, percutaneous endoscopic approach. left colic artery, open approach. left colic artery, percutaneous approach. left colic artery, percutaneous endoscopic approach. middle colic artery, open approach. middle colic artery, percutaneous approach. middle colic artery, percutaneous endoscopic approach. right renal artery, open approach. right renal artery, percutaneous approach. right renal artery, percutaneous endoscopic approach. left renal artery, open approach. left renal artery, percutaneous approach. left renal artery, percutaneous endoscopic approach. Frm 00048 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.06—Continued ICD–10–PCS code 04CB0ZZ ...................... 04CB3ZZ ...................... 04CB4ZZ ...................... 04CC0ZZ ...................... 04CC3ZZ ...................... 04CC4ZZ ...................... 04CD0ZZ ...................... 04CD3ZZ ...................... 04CD4ZZ ...................... 04CE0ZZ ...................... 04CE3ZZ ...................... 04CE4ZZ ...................... 04CF0ZZ ....................... 04CF3ZZ ....................... 04CF4ZZ ....................... 04CH0ZZ ...................... 04CH3ZZ ...................... 04CH4ZZ ...................... 04CJ0ZZ ....................... 04CJ3ZZ ....................... 04CJ4ZZ ....................... Code description Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation of of of of of of of of of of of of of of of of of of of of of matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter from from from from from from from from from from from from from from from from from from from from from inferior mesenteric artery, open approach. inferior mesenteric artery, percutaneous approach. inferior mesenteric artery, percutaneous endoscopic approach. right common iliac artery, open approach. right common iliac artery, percutaneous approach. right common iliac artery, percutaneous endoscopic approach. left common iliac artery, open approach. left common iliac artery, percutaneous approach. left common iliac artery, percutaneous endoscopic approach. right internal iliac artery, open approach. right internal iliac artery, percutaneous approach. right internal iliac artery, percutaneous endoscopic approach. left internal iliac artery, open approach. left internal iliac artery, percutaneous approach. left internal iliac artery, percutaneous endoscopic approach. right external iliac artery, open approach. right external iliac artery, percutaneous approach. right external iliac artery, percutaneous endoscopic approach. left external iliac artery, open approach. left external iliac artery, percutaneous approach. left external iliac artery, percutaneous endoscopic approach. ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.07 tkelley on DSK3SPTVN1PROD with PROPOSALS2 ICD–10–PCS code 06C00ZZ ....................... 06C03ZZ ....................... 06C04ZZ ....................... 06C10ZZ ....................... 06C13ZZ ....................... 06C14ZZ ....................... 06C20ZZ ....................... 06C23ZZ ....................... 06C24ZZ ....................... 06C40ZZ ....................... 06C43ZZ ....................... 06C44ZZ ....................... 06C50ZZ ....................... 06C53ZZ ....................... 06C54ZZ ....................... 06C60ZZ ....................... 06C63ZZ ....................... 06C64ZZ ....................... 06C70ZZ ....................... 06C73ZZ ....................... 06C74ZZ ....................... 06C80ZZ ....................... 06C83ZZ ....................... 06C84ZZ ....................... 06C90ZZ ....................... 06C93ZZ ....................... 06C94ZZ ....................... 06CB0ZZ ...................... 06CB3ZZ ...................... 06CB4ZZ ...................... 06CC0ZZ ...................... 06CC3ZZ ...................... 06CC4ZZ ...................... 06CD0ZZ ...................... 06CD3ZZ ...................... 06CD4ZZ ...................... 06CF0ZZ ....................... 06CF3ZZ ....................... 06CF4ZZ ....................... 06CG0ZZ ...................... 06CG3ZZ ...................... 06CG4ZZ ...................... 06CH0ZZ ...................... 06CH3ZZ ...................... 06CH4ZZ ...................... VerDate Sep<11>2014 Code description Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation 18:20 Apr 29, 2015 of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter Jkt 235001 from from from from from from from from from from from from from from from from from from from from from from from from from from from from from from from from from from from from from from from from from from from from from PO 00000 inferior vena cava, open approach. inferior vena cava, percutaneous approach. inferior vena vava, percutaneous endoscopic approach. splenic vein, open approach. splenic vein, percutaneous approach. splenic vein, percutaneous endoscopic approach. gastric vein, open approach. gastric vein, percutaneous approach. gastric vein, percutaneous endoscopic approach. hepatic vein, open approach. hepatic vein, percutaneous approach. hepatic vein, percutaneous endoscopic approach. superior mesenteric vein, open approach. superior mesenteric vein, percutaneous approach. superior mesenteric vein, percutaneous endoscopic approach. inferior mesenteric vein, open approach. inferior mesenteric vein, percutaneous approach. inferior mesenteric vein, percutaneous endoscopic approach. colic vein, open approach. colic vein, percutaneous approach. colic vein, percutaneous endoscopic approach. portal vein, open approach. portal vein, percutaneous approach. portal vein, percutaneous endoscopic approach. right renal vein, open approach. right renal vein, percutaneous approach. right renal vein, percutaneous endoscopic approach. left renal vein, open approach. left renal vein, percutaneous approach. left renal vein, percutaneous endoscopic approach. right common iliac vein, open approach. right common iliac vein, percutaneous approach. right common iliac vein, percutaneous endoscopic approach. left common iliac vein, open approach. left common iliac vein, percutaneous approach. left common iliac vein, percutaneous endoscopic approach. right external iliac vein, open approach. right external iliac vein, percutaneous approach. right external iliac vein, percutaneous endoscopic approach. left external iliac vein, open approach. left external iliac vein, percutaneous approach. left external iliac vein, percutaneous endoscopic approach. right hypogastric vein, open approach. right hypogastric vein, percutaneous approach. right hypogastric vein, percutaneous endoscopic approach. Frm 00049 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 24371 24372 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.07—Continued ICD–10–PCS code 06CJ0ZZ ....................... 06CJ3ZZ ....................... 06CJ4ZZ ....................... Code description Extirpation of matter from left hypogastric vein, open approach. Extirpation of matter from left hypogastric vein, percutaneous approach. 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 02CP0ZZ ...................... 02CP3ZZ ...................... 02CP4ZZ ...................... 02CQ0ZZ ...................... 02CQ3ZZ ...................... 02CQ4ZZ ...................... 02CR0ZZ ...................... 02CR3ZZ ...................... 02CR4ZZ ...................... 02CS0ZZ ...................... 02CS3ZZ ...................... 02CS4ZZ ...................... 02CT0ZZ ....................... 02CT3ZZ ....................... 02CT4ZZ ....................... 02CV0ZZ ...................... 02CV3ZZ ...................... 02CV4ZZ ...................... 03C00ZZ ....................... 03C03ZZ ....................... 03C04ZZ ....................... 03C10ZZ ....................... 03C13ZZ ....................... 03C14ZZ ....................... 03C20ZZ ....................... 03C23ZZ ....................... 03C24ZZ ....................... 03C30ZZ ....................... 03C33ZZ ....................... 03C34ZZ ....................... 03C40ZZ ....................... 03C43ZZ ....................... 03C44ZZ ....................... Code description Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation Extirpation of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter matter from from from from from from from from from from from from from from from from from from from from from from from from from from from from from from from from from pulmonary trunk, open approach. pulmonary trunk, percutaneous approach. pulmonary trunk, percutaneous endoscopic approach. right pulmonary artery, open approach. right pulmonary artery, percutaneous approach. right pulmonary artery, percutaneous endoscopic approach. left pulmonary artery, open approach. left pulmonary artery, percutaneous approach. left pulmonary artery, percutaneous endoscopic approach. right pulmonary vein, open approach. right pulmonary vein, percutaneous approach. right pulmonary vein, percutaneous endoscopic approach. left pulmonary vein, open approach. left pulmonary vein, percutaneous approach. left pulmonary vein, percutaneous endoscopic approach. superior vena cava, open approach. superior vena cava, percutaneous approach. superior vena cava, percutaneous endoscopic approach. right internal mammary artery, open approach. right internal mammary artery, percutaneous approach. right internal mammary artery, percutaneous endoscopic approach. left internal mammary artery, open approach. left internal mammary artery, percutaneous approach. left internal mammary artery, percutaneous endoscopic approach. innominate artery, open approach. innominate artery, percutaneous approach. innominate artery, percutaneous endoscopic approach. right subclavian artery, open approach. right subclavian artery, percutaneous approach. right subclavian artery, percutaneous endoscopic approach. left subclavian artery, open approach. left subclavian artery, percutaneous approach. left subclavian artery, percutaneous endoscopic approach. ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.16 ICD–10–PCS code Code description The comparable ICD–10–PCS code translations for ICD–9–CM procedure code 38.16 are shown in Table 6P.1c for this proposed rule, which is available via the Internet on the CMS Web site at: https://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 tkelley on DSK3SPTVN1PROD with PROPOSALS2 ICD–10–PCS code 02BP0ZZ ....................... 02BP4ZZ ....................... 02BQ0ZZ ...................... 02BQ4ZZ ...................... 02BR0ZZ ...................... 02BR4ZZ ...................... 02BS0ZZ ....................... 02BS4ZZ ....................... 02BT0ZZ ....................... 02BT4ZZ ....................... 02BV0ZZ ....................... 02BV4ZZ ....................... 03B00ZZ ....................... 03B04ZZ ....................... 03B10ZZ ....................... VerDate Sep<11>2014 Code description Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision 18:20 Apr 29, 2015 of of of of of of of of of of of of of of of pulmonary trunk, open approach. pulmonary trunk, percutaneous endoscopic approach. right pulmonary artery, open approach. right pulmonary artery, percutaneous endoscopic approach. left pulmonary artery, open approach. left pulmonary artery, percutaneous endoscopic approach. right pulmonary vein, open approach. right pulmonary vein, percutaneous endoscopic approach. left pulmonary vein, open approach. left pulmonary vein, percutaneous endoscopic approach. superior vena cava, open approach. superior vena cava, percutaneous endoscopic approach. right internal mammary artery, open approach. right internal mammary artery, percutaneous endoscopic approach. left internal mammary artery, open approach. Jkt 235001 PO 00000 Frm 00050 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.35—Continued ICD–10–PCS code 03B14ZZ 03B20ZZ 03B24ZZ 03B30ZZ 03B34ZZ 03B40ZZ 03B44ZZ 05B00ZZ 05B04ZZ 05B10ZZ 05B14ZZ 05B30ZZ 05B34ZZ 05B40ZZ 05B44ZZ 05B50ZZ 05B54ZZ 05B60ZZ 05B64ZZ ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... Code description Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision of of of of of of of of of of of of of of of of of of of left internal mammary artery, percutaneous endoscopic approach. innominate artery, open approach. innominate artery, percutaneous endoscopic approach. right subclavian artery, open approach. right subclavian artery, percutaneous endoscopic approach. left subclavian artery, open approach. left subclavian artery, percutaneous endoscopic approach. azygos vein, open approach. azygos vein, percutaneous endoscopic approach. hemiazygos vein, open approach. hemiazygos vein, percutaneous endoscopic approach. right innominate vein, open approach. right innominate vein, percutaneous endoscopic approach. left innominate vein, open approach. left innominate vein, percutaneous endoscopic approach. right subclavian vein, open approach. right subclavian vein, percutaneous endoscopic approach. left subclavian vein, open approach. left subclavian vein, percutaneous endoscopic approach. ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.36 ICD–10–PCS code 04B10ZZ 04B14ZZ 04B20ZZ 04B24ZZ 04B30ZZ 04B34ZZ 04B40ZZ 04B44ZZ 04B50ZZ 04B54ZZ 04B60ZZ 04B64ZZ 04B70ZZ 04B74ZZ 04B80ZZ 04B84ZZ 04B90ZZ 04B94ZZ 04BA0ZZ 04BA4ZZ 04BB0ZZ 04BB4ZZ 04BC0ZZ 04BC4ZZ 04BD0ZZ 04BD4ZZ 04BE0ZZ 04BE4ZZ 04BF0ZZ 04BF4ZZ 04BH0ZZ 04BH4ZZ 04BJ0ZZ 04BJ4ZZ ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ...................... ...................... ...................... ...................... ....................... ....................... ....................... ....................... ...................... ...................... ....................... ....................... Code description Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of celiac artery, open approach. celiac artery, percutaneous endoscopic approach. gastric artery, open approach. gastric artery, percutaneous endoscopic approach. hepatic artery, open approach. hepatic artery, percutaneous endoscopic approach. splenic artery, open approach. splenic artery, percutaneous endoscopic approach. superior mesenteric artery, open approach. superior mesenteric artery, percutaneous endoscopic approach. right colic artery, open approach. right colic artery, percutaneous endoscopic approach. left colic artery, open approach. left colic artery, percutaneous endoscopic approach. middle colic artery, open approach. middle colic artery, percutaneous endoscopic approach. right renal artery, open approach. right renal artery, percutaneous endoscopic approach. left renal artery, open approach. left renal artery, percutaneous endoscopic approach. inferior mesenteric artery, open approach. inferior mesenteric artery, percutaneous endoscopic approach. right common iliac artery, open approach. right common iliac artery, percutaneous endoscopic approach. left common iliac artery, open approach. left common iliac artery, percutaneous endoscopic approach. right internal iliac artery, open approach. right internal iliac artery, percutaneous endoscopic approach. left internal iliac artery, open approach. left internal iliac artery, percutaneous endoscopic approach. right external iliac artery, open approach. right external iliac artery, percutaneous endoscopic approach. left external iliac artery, open approach. left external iliac artery, percutaneous endoscopic approach. tkelley on DSK3SPTVN1PROD with PROPOSALS2 ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.37 ICD–10–PCS code 06B00ZZ 06B04ZZ 06B10ZZ 06B14ZZ 06B20ZZ 06B24ZZ 06B40ZZ ....................... ....................... ....................... ....................... ....................... ....................... ....................... VerDate Sep<11>2014 Code description Excision Excision Excision Excision Excision Excision Excision 18:20 Apr 29, 2015 of of of of of of of inferior vena cava, open approach. inferior vena cava, percutaneous endoscopic approach. splenic vein, open approach. splenic vein, percutaneous endoscopic approach. gastric vein, open approach. gastric vein, percutaneous endoscopic approach. hepatic vein, open approach. Jkt 235001 PO 00000 Frm 00051 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 24373 24374 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.37—Continued ICD–10–PCS code 06B44ZZ ....................... 06B50ZZ ....................... 06B54ZZ ....................... 06B60ZZ ....................... 06B64ZZ ....................... 06B70ZZ ....................... 06B74ZZ ....................... 06B80ZZ ....................... 06B84ZZ ....................... 06B90ZZ ....................... 06B94ZZ ....................... 06BB0ZZ ....................... 06BB4ZZ ....................... 06BC0ZZ ...................... 06BC4ZZ ...................... 06BD0ZZ ...................... 06BD4ZZ ...................... 06BF0ZZ ....................... 06BF4ZZ ....................... 06BG0ZZ ...................... 06BG4ZZ ...................... 06BH0ZZ ...................... 06BH4ZZ ...................... 06BJ0ZZ ....................... 06BJ4ZZ ....................... Code description Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision Excision of of of of of of of of of of of of of of of of of of of of of of of of of hepatic vein, percutaneous endoscopic approach. superior mesenteric vein, open approach. superior mesenteric vein, percutaneous endoscopic approach. inferior mesenteric vein, open approach. inferior mesenteric vein, percutaneous endoscopic approach. colic vein, open approach. colic vein, percutaneous endoscopic approach. portal vein, open approach. portal vein, percutaneous endoscopic approach. right renal vein, open approach. right renal vein, percutaneous endoscopic approach. left renal vein, open approach. left renal vein, percutaneous endoscopic approach. right common iliac vein, open approach. right common iliac vein, percutaneous endoscopic approach. left common iliac vein, open approach. left common iliac vein, percutaneous endoscopic approach. right external iliac vein, open approach. right external iliac vein, percutaneous endoscopic approach. left external iliac vein, open approach. left external iliac vein, percutaneous endoscopic approach. right hypogastric vein, open approach. right hypogastric vein, percutaneous endoscopic approach. left hypogastric vein, open approach. 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 proposed rule, which is available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/ index.html. ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.47 ICD–10–PCS code Code description The comparable ICD–10–PCS code translations for ICD–9–CM procedure code 38.47 are shown in Table 6P.1e for this proposed rule, which is available via the Internet on the CMS Web site at: https://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 proposed rule, which is available via the Internet on the CMS Web site at: https://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 tkelley on DSK3SPTVN1PROD with PROPOSALS2 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 proposed rule, which is available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/ index.html. VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00052 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 24375 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 proposed rule, which is available via the Internet on the CMS Web site at: https://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 proposed rule, which is available via the Internet on the CMS Web site at: https://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 proposed rule, which is available via the Internet on the CMS Web site at: https://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 proposed rule, which is available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/ index.html. 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 proposed rule, which is available via the Internet on the CMS Web site at: https://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 proposed rule, which is available via the Internet on the CMS Web site at: https://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 tkelley on DSK3SPTVN1PROD with PROPOSALS2 ICD–10–PCS code Code description 021V09P ....................... 021V09Q ....................... 021V09R ....................... 021V0AP ....................... 021V0AQ ...................... 021V0AR ...................... 021V0JP ....................... 021V0JQ ....................... 021V0JR ....................... 021V0KP ....................... 021V0KQ ...................... 021V0KR ...................... 021V0ZP ....................... 021V0ZQ ...................... 021V0ZR ....................... 021V49P ....................... 021V49Q ....................... Bypass superior vena cava to pulmonary trunk with autologous venous tissue, open approach. Bypass superior vena cava to right pulmonary artery with autologous venous tissue, open approach. Bypass superior vena cava to left pulmonary artery with autologous venous tissue, open approach. Bypass superior vena cava to pulmonary trunk with autologous arterial tissue, open approach. Bypass superior vena cava to right pulmonary artery with autologous arterial tissue, open approach. Bypass superior vena cava to left pulmonary artery with autologous arterial tissue, open approach. Bypass superior vena cava to pulmonary trunk with synthetic substitute, open approach. Bypass superior vena cava to right pulmonary artery with synthetic substitute, open approach. Bypass superior vena cava to left pulmonary artery with synthetic substitute, open approach. Bypass superior vena cava to pulmonary trunk with nonautologous tissue substitute, open approach. Bypass superior vena cava to right pulmonary artery with nonautologous tissue substitute, open approach. Bypass superior vena cava to left pulmonary artery with nonautologous tissue substitute, open approach. Bypass superior vena cava to pulmonary trunk, open approach. Bypass superior vena cava to right pulmonary artery, open approach. Bypass superior vena cava to left pulmonary artery, open approach. Bypass superior vena cava to pulmonary trunk with autologous venous tissue, percutaneous endoscopic approach. Bypass superior vena cava to right pulmonary artery with autologous venous tissue, percutaneous endoscopic approach. VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00053 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 24376 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 39.21—Continued ICD–10–PCS code Code description 021V49R ....................... Bypass superior vena cava to left pulmonary artery with autologous venous tissue, percutaneous endoscopic approach. Bypass superior vena cava to pulmonary trunk with autologous arterial tissue, percutaneous endoscopic approach. Bypass superior vena cava to right pulmonary artery with autologous arterial tissue, percutaneous endoscopic approach. Bypass superior vena cava to left pulmonary artery with autologous arterial tissue, percutaneous endoscopic approach. Bypass superior vena cava to pulmonary trunk with synthetic substitute, percutaneous endoscopic approach. Bypass superior vena cava to right pulmonary artery with synthetic substitute, percutaneous endoscopic approach. Bypass superior vena cava to left pulmonary artery with synthetic substitute, percutaneous endoscopic approach. Bypass superior vena cava to pulmonary trunk with nonautologous tissue substitute, percutaneous endoscopic approach. Bypass superior vena cava to right pulmonary artery with nonautologous tissue substitute, percutaneous endoscopic approach. Bypass superior vena cava to left pulmonary artery with nonautologous tissue substitute, percutaneous endoscopic approach. Bypass superior vena cava to pulmonary trunk, percutaneous endoscopic approach. Bypass superior vena cava to right pulmonary artery, percutaneous endoscopic approach. Bypass superior vena cava to left pulmonary artery, percutaneous endoscopic approach. 021V4AP ....................... 021V4AQ ...................... 021V4AR ...................... 021V4JP 021V4JQ 021V4JR 021V4KP ....................... ....................... ....................... ....................... 021V4KQ ...................... 021V4KR ...................... 021V4ZP ....................... 021V4ZQ ...................... 021V4ZR ....................... ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 39.22 ICD–10–PCS code 021W09B 021W09D 021W0AB 021W0AD 021W0JB 021W0JD 021W0KB 021W0KD 021W0ZB 021W0ZD 021W49B 021W49D 021W4AB 021W4AD 021W4JB 021W4JD 021W4KB 021W4KD 021W4ZB 021W4ZD ...................... ...................... ...................... ..................... ...................... ...................... ...................... ..................... ...................... ...................... ...................... ...................... ...................... ..................... ...................... ...................... ...................... ..................... ...................... ...................... Code description Bypass Bypass Bypass Bypass Bypass Bypass Bypass Bypass Bypass Bypass Bypass Bypass Bypass Bypass Bypass Bypass Bypass Bypass Bypass Bypass thoracic thoracic thoracic thoracic thoracic thoracic thoracic thoracic thoracic thoracic thoracic thoracic thoracic thoracic thoracic thoracic thoracic thoracic thoracic thoracic aorta aorta aorta aorta aorta aorta aorta aorta aorta aorta aorta aorta aorta aorta aorta aorta aorta aorta aorta aorta to to to to to to to to to to to to to to to to to to to to subclavian with autologous venous tissue, open approach). carotid with autologous venous tissue, open approach). subclavian with autologous arterial tissue, open approach. carotid with autologous arterial tissue, open approach. subclavian with synthetic substitute, open approach. carotid with synthetic substitute, open approach. subclavian with nonautologous tissue substitute, open approach. carotid with nonautologous tissue substitute, open approach. subclavian, open approach. carotid, open approach. subclavian with autologous venous tissue, percutaneous endoscopic approach. carotid with autologous venous tissue, percutaneous endoscopic approach. subclavian with autologous arterial tissue, percutaneous endoscopic approach. carotid with autologous arterial tissue, percutaneous endoscopic approach. subclavian with synthetic substitute, percutaneous endoscopic approach. carotid with synthetic substitute, percutaneous endoscopic approach. subclavian with nonautologous tissue substitute, percutaneous endoscopic approach. carotid with nonautologous tissue substitute, percutaneous endoscopic approach. subclavian, percutaneous endoscopic approach. 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 proposed rule, which is available via the Internet on the CMS Web site at: https://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 tkelley on DSK3SPTVN1PROD with PROPOSALS2 The comparable ICD–10–PCS code translations for ICD–9–CM procedure code 39.25 are shown in Table 6P.1o for this proposed rule, which is available via the Internet on the CMS Web site at: https://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 proposed rule, which is available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/ index.html. VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00054 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 24377 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 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 proposed rule, which is available via the Internet on the CMS Web site at: https://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 02QW0ZZ ..................... 02QW3ZZ ..................... 02QW4ZZ ..................... Code description Repair thoracic aorta, open approach. Repair thoracic aorta, percutaneous approach. Repair thoracic aorta, percutaneous endoscopic approach. ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 39.72 ICD–10–PCS code 03LR0DZ 03LR3DZ 03LR4DZ 03LS0DZ 03LS3DZ 03LS4DZ 03LT0DZ 03LT3DZ 03LT4DZ ...................... ...................... ...................... ....................... ....................... ....................... ....................... ....................... ....................... Code description Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion of of of of of of of of of face artery with intraluminal device, open approach. face artery with intraluminal device, percutaneous approach. face artery with intraluminal device, percutaneous endoscopic approach. right temporal artery with intraluminal device, open approach. right temporal artery with intraluminal device, percutaneous approach. right temporal artery with intraluminal device, percutaneous endoscopic approach. left temporal artery with intraluminal device, open approach. left temporal artery with intraluminal device, percutaneous approach. 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 proposed rule, which is available via the Internet on the CMS Web site at: https://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 proposed rule, which is available via the Internet on the CMS Web site at: https://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 tkelley on DSK3SPTVN1PROD with PROPOSALS2 The comparable ICD–10–PCS code translations for ICD–9–CM procedure code 39.79 are shown in Table 6P.1t for this proposed rule, which is available via the Internet on the CMS Web site at: https://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 cases MS–DRG MS–DRGs 237 and 238—Combined .......................................................................................... VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00055 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 50,567 30APP2 Average length of stay 5.8 Average costs $29,174 24378 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules MAJOR CARDIOVASCULAR PROCEDURES WITH AND WITHOUT MCC—Continued Number of cases MS–DRG MS–DRGs 237 and 238—Cases with more complex, more invasive 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 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 are proposing 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 are proposing 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 are proposing to create MS–DRG 268, entitled ‘‘Aortic Average length of stay Average costs 22,278 4.0 31,729 28,289 7.1 27,162 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. PROPOSED NEW MS–DRGS FOR AORTIC AND HEART ASSIST PROCEDURES Number of cases MS–DRG Proposed New MS–DRG 268 with MCC .................................................................................... Proposed New MS–DRG 269 without MCC ............................................................................... We are inviting public comments on this proposal and the ICD–10–PCS code translations for these procedures shown earlier in this section, which we also are proposing 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 3way severity level split (with MCC, with CC, and without CC/MCC) was justified. Therefore, we are proposing 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 are proposing 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, Average length of stay 4,182 18,096 10.03 2.68 Average costs $45,996 28,431 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 believe 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 cases MS–DRG tkelley on DSK3SPTVN1PROD with PROPOSALS2 Proposed New MS–DRG 270 with MCC .................................................................................... Proposed New MS–DRG 271 with CC ....................................................................................... Proposed New MS–DRG 272 without CC/MCC ......................................................................... We are inviting 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 are proposing to assign to proposed new MS–DRGs 270, 271, and 272. In summary, for FY 2016, we are proposing to delete MS–DRGs 237 and 238, and to create the following five new MS–DRGs: VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 • 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); PO 00000 Frm 00056 Fmt 4701 Sfmt 4702 14,158 9,648 4,483 Average length of stay 9.3 5.99 3.08 Average costs $33,507 22,800 16,438 • 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 are proposing 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 E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 268 and 269. In addition, we are proposing 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 encourage public comments on our proposal to create these proposed new MS–DRGs, as well as the ICD–10–PCS code translations that we are proposing to assign to the corresponding proposed new MS–DRGs. 4. MDC 8 (Diseases and Disorders of the Musculoskeletal System and Connective Tissue) a. 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 joint revisions. One of the commenters requested that CMS change the MS–DRG structure for 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 revision cases coded with ICD–9–CM codes are assigned to MS–DRGs 466, 467, and 468, but similar cases reported with these ICD–10–PCS codes are not assigned to MS–DRGs 466, 467, and 468 in ICD–10–PCS MS–DRGs Version 32. 24379 We agree that joint revision cases with the removal of a spacer and subsequent insertion of a new joint prosthesis should be assigned to 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 revisions that involve cemented and uncemented qualifiers should be assigned to 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 MS–DRGs would have the same logic as the ICD–9–CM MS–DRGs. We are proposing to add the following code combinations which capture the joint revisions to the Version 33 MS–DRG structure for ICD–10 MS–DRGs 466, 467, and 468 that we are proposing to implement effective October 1, 2015. MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND 468: PROPOSED NEW HIP REVISION ICD–10–PCS COMBINATIONS ICD–10–PCS code 0SP908Z ...... ICD–10–PCS code Code description Replacement of right hip joint with metal synthetic substitute, cemented, open approach. Replacement of right hip joint with metal synthetic substitute, uncemented, open approach. Replacement of right hip joint with metal synthetic substitute, open approach. Replacement of right hip joint with metal on polyethylene synthetic substitute, cemented, open approach. Replacement of right hip joint with metal on polyethylene synthetic substitute, uncemented, open approach. Replacement of right hip joint with metal on polyethylene synthetic substitute, open approach. Replacement of right hip joint with ceramic synthetic substitute, cemented, open approach. Replacement of right hip joint with ceramic synthetic substitute, uncemented, open approach. Replacement of right hip joint with ceramic synthetic substitute, open approach. Replacement of right hip joint with ceramic on polyethylene synthetic substitute, cemented, open approach. Replacement of right hip joint with ceramic on polyethylene synthetic substitute, uncemented, open approach. Replacement of right hip joint with ceramic on polyethylene synthetic substitute, open approach. Replacement of right hip joint with synthetic substitute, cemented, open approach. Replacement of right hip joint with synthetic substitute, uncemented, open approach. Replacement of right hip joint with synthetic substitute, open approach. Replacement of right hip joint, acetabular surface with polyethylene synthetic substitute, cemented, open approach. spacer from right hip joint, open ap- and 0SR9019 ..... spacer from right hip joint, open ap- and 0SR901A ..... spacer from right hip joint, open ap- and 0SR901Z ..... spacer from right hip joint, open ap- and 0SR9029 ..... 0SP908Z ...... Removal of spacer from right hip joint, open approach. and 0SR902A ..... 0SP908Z ...... Removal of proach. Removal of proach. Removal of proach. Removal of proach. Removal of proach. spacer from right hip joint, open ap- and 0SR902Z ..... spacer from right hip joint, open ap- and 0SR9039 ..... spacer from right hip joint, open ap- and 0SR903A ..... spacer from right hip joint, open ap- and 0SR903Z ..... spacer from right hip joint, open ap- and 0SR9049 ..... 0SP908Z ...... Removal of spacer from right hip joint, open approach. and 0SR904A ..... 0SP908Z ...... Removal of proach. Removal of proach. Removal of proach. Removal of proach. Removal of proach. spacer from right hip joint, open ap- and 0SR904Z ..... spacer from right hip joint, open ap- and 0SR90J9 ..... spacer from right hip joint, open ap- and 0SR90JA ..... spacer from right hip joint, open ap- and 0SR90JZ ..... spacer from right hip joint, open ap- and 0SRA009 ..... 0SP908Z ...... 0SP908Z ...... 0SP908Z ...... 0SP908Z ...... 0SP908Z ...... 0SP908Z ...... tkelley on DSK3SPTVN1PROD with PROPOSALS2 0SP908Z ...... 0SP908Z ...... 0SP908Z ...... 0SP908Z ...... 0SP908Z ...... VerDate Sep<11>2014 Removal of proach. Removal of proach. Removal of proach. Removal of proach. Code description 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00057 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 24380 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND 468: PROPOSED NEW HIP REVISION ICD–10–PCS COMBINATIONS—Continued ICD–10–PCS code Code description ICD–10–PCS code Code description 0SP908Z ...... Removal of spacer from right hip joint, open approach. and 0SRA00A .... Removal of spacer from right hip joint, open approach. and 0SRA00Z ..... 0SP908Z ...... Removal of spacer from right hip joint, open approach. and 0SRA019 ..... 0SP908Z ...... Removal of spacer from right hip joint, open approach. and 0SRA01A .... 0SP908Z ...... and 0SRA01Z ..... 0SP908Z ...... Removal of spacer from right hip joint, open approach. Removal of spacer from right hip joint, open approach. and 0SRA039 ..... 0SP908Z ...... Removal of spacer from right hip joint, open approach. and 0SRA03A .... 0SP908Z ...... Removal of spacer from right hip joint, open approach. and 0SRA03Z ..... 0SP908Z ...... Removal of spacer from right hip joint, open approach. and 0SRA0J9 ..... 0SP908Z ...... Removal of spacer from right hip joint, open approach. and 0SRA0JA ..... 0SP908Z ...... and 0SRA0JZ ..... 0SP908Z ...... Removal of spacer from right hip joint, open approach. Removal of spacer from right hip joint, open approach. and 0SRR019 ..... 0SP908Z ...... Removal of spacer from right hip joint, open approach. and 0SRR01A .... 0SP908Z ...... and 0SRR01Z .... 0SP908Z ...... Removal of spacer from right hip joint, open approach. Removal of spacer from right hip joint, open approach. and 0SRR039 ..... 0SP908Z ...... Removal of spacer from right hip joint, open approach. and 0SRR03A .... 0SP908Z ...... Removal of spacer from right hip joint, open approach. Removal of spacer from right hip joint, open approach. Removal of spacer from right hip joint, open approach. and 0SRR03Z .... and 0SRR0J9 ..... and 0SRR0JA .... Removal of proach. Removal of proach. Removal of proach. Removal of proach. Removal of proach. Removal of proach. Removal of proach. Removal of proach. spacer from right hip joint, open ap- and 0SRR0JZ ..... spacer from right hip joint, open ap- and 0SU909Z ..... spacer from right hip joint, open ap- and 0SUA09Z ..... spacer from right hip joint, open ap- and 0SUR09Z .... liner from right hip joint, open ap- and 0SR9019 ..... liner from right hip joint, open ap- and 0SR901A ..... liner from right hip joint, open ap- and 0SR901Z ..... liner from right hip joint, open ap- and 0SR9029 ..... Replacement of right hip joint, acetabular surface with polyethylene synthetic substitute, uncemented, open approach. Replacement of right hip joint, acetabular surface with polyethylene synthetic substitute, open approach. Replacement of right hip joint, acetabular surface with metal synthetic substitute, cemented, open approach. Replacement of right hip joint, acetabular surface with metal synthetic substitute, uncemented, open approach. Replacement of right hip joint, acetabular surface with metal synthetic substitute, open approach. Replacement of right hip joint, acetabular surface with ceramic synthetic substitute, cemented, open approach. Replacement of right hip joint, acetabular surface with ceramic synthetic substitute, uncemented, open approach. Replacement of right hip joint, acetabular surface with ceramic synthetic substitute, open approach. Replacement of right hip joint, acetabular surface with synthetic substitute, cemented, pen approach. Replacement of right hip joint, acetabular surface with synthetic substitute, uncemented, open approach. Replacement of right hip joint, acetabular surface with synthetic substitute, open approach. Replacement of right hip joint, femoral surface with metal synthetic substitute, cemented, open approach. Replacement of right hip joint, femoral surface with metal synthetic substitute, uncemented, open approach. Replacement of right hip joint, femoral surface with metal synthetic substitute, open approach. Replacement of right hip joint, femoral surface with ceramic synthetic substitute, cemented, open approach. Replacement of right hip joint, femoral surface with ceramic synthetic substitute, uncemented, open approach. Replacement of right hip joint, femoral surface with ceramic synthetic substitute, open approach. Replacement of right hip joint, femoral surface with synthetic Substitute, cemented, open approach. Replacement of right hip joint, femoral surface with synthetic Substitute, uncemented, open approach. Replacement of right hip joint, femoral surface with synthetic substitute, open approach. Supplement right hip joint with liner, open approach. Supplement right hip joint, acetabular surface with liner, open approach. Supplement right hip joint, femoral surface with liner, open approach. Replacement of right hip joint with metal synthetic substitute, cemented, open approach. Replacement of right hip joint with metal synthetic substitute, uncemented, open approach. Replacement of right hip joint with metal synthetic substitute, open approach. Replacement of right hip joint with metal on polyethylene synthetic substitute, cemented, open approach. 0SP908Z ...... 0SP908Z ...... 0SP908Z ...... 0SP908Z ...... 0SP908Z ...... 0SP908Z ...... tkelley on DSK3SPTVN1PROD with PROPOSALS2 0SP908Z ...... 0SP909Z ...... 0SP909Z ...... 0SP909Z ...... 0SP909Z ...... VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00058 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 24381 MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND 468: PROPOSED NEW HIP REVISION ICD–10–PCS COMBINATIONS—Continued ICD–10–PCS code Code description ICD–10–PCS code Code description 0SP909Z ...... Removal of liner from right hip joint, open approach. and 0SR902A ..... liner from right hip joint, open ap- and 0SR902Z ..... liner from right hip joint, open ap- and 0SR9039 ..... liner from right hip joint, open ap- and 0SR903A ..... liner from right hip joint, open ap- and 0SR903Z ..... liner from right hip joint, open ap- and 0SR9049 ..... 0SP909Z ...... Removal of liner from right hip joint, open approach. and 0SR904A ..... 0SP909Z ...... Removal of proach. Removal of proach. Removal of proach. Removal of proach. Removal of proach. liner from right hip joint, open ap- and 0SR904Z ..... liner from right hip joint, open ap- and 0SR90J9 ..... liner from right hip joint, open ap- and 0SR90JA ..... liner from right hip joint, open ap- and 0SR90JZ ..... liner from right hip joint, open ap- and 0SRA009 ..... 0SP909Z ...... Removal of liner from right hip joint, open approach. and 0SRA00A .... 0SP909Z ...... Removal of liner from right hip joint, open approach. and 0SRA00Z ..... 0SP909Z ...... Removal of liner from right hip joint, open approach. and 0SRA019 ..... 0SP909Z ...... Removal of liner from right hip joint, open approach. and 0SRA01A .... 0SP909Z ...... and 0SRA01Z ..... 0SP909Z ...... Removal of liner from right hip joint, open approach. Removal of liner from right hip joint, open approach. and 0SRA039 ..... 0SP909Z ...... Removal of liner from right hip joint, open approach. and 0SRA03A .... 0SP909Z ...... Removal of liner from right hip joint, open approach. and 0SRA03Z ..... 0SP909Z ...... Removal of liner from right hip joint, open approach. and 0SRA0J9 ..... 0SP909Z ...... Removal of liner from right hip joint, open approach. and 0SRA0JA ..... 0SP909Z ...... and 0SRA0JZ ..... 0SP909Z ...... Removal of liner from right hip joint, open approach. Removal of liner from right hip joint, open approach. and 0SRR019 ..... 0SP909Z ...... Removal of liner from right hip joint, open approach. and 0SRR01A .... 0SP909Z ...... Removal of liner from right hip joint, open approach. and 0SRR01Z .... Replacement of right hip joint with metal on polyethylene synthetic substitute, uncemented, open approach. Replacement of right hip joint with metal on polyethylene synthetic substitute, open approach. Replacement of right hip joint with ceramic synthetic substitute, cemented, open approach. Replacement of right hip joint with ceramic synthetic substitute, uncemented, open approach. Replacement of right hip joint with ceramic synthetic substitute, open approach. Replacement of right hip joint with ceramic on polyethylene synthetic substitute, cemented, open approach. Replacement of right hip joint with ceramic on polyethylene synthetic substitute, uncemented, open approach. Replacement of right hip joint with ceramic on polyethylene synthetic substitute, open approach. Replacement of right hip joint with synthetic substitute, cemented, open approach. Replacement of right hip joint with synthetic substitute, uncemented, open approach. Replacement of right hip joint with synthetic substitute, open approach. Replacement of right hip joint, acetabular surface with polyethylene synthetic substitute, cemented, open approach. Replacement of right hip joint, acetabular surface with polyethylene synthetic substitute, uncemented, open approach. Replacement of right hip joint, acetabular surface with polyethylene synthetic substitute, open approach. Replacement of right hip joint, acetabular surface with metal synthetic substitute, cemented, open approach. Replacement of right hip joint, acetabular surface with metal synthetic substitute, uncemented, open approach. Replacement of right hip joint, acetabular surface with metal synthetic substitute, open approach. Replacement of right hip joint, acetabular surface with ceramic synthetic substitute, cemented, open approach. Replacement of right hip joint, acetabular surface with ceramic synthetic substitute, uncemented, open approach. Replacement of right hip joint, acetabular surface with ceramic synthetic substitute, open approach. Replacement of right hip joint, acetabular surface with synthetic substitute, cemented, open approach. Replacement of right hip joint, acetabular surface with synthetic substitute, uncemented, open approach. Replacement of right hip joint, acetabular surface with synthetic substitute, open approach. Replacement of right hip joint, femoral surface with metal synthetic substitute, cemented, open approach. Replacement of right hip joint, femoral surface with metal synthetic substitute, uncemented, open approach. Replacement of right hip joint, femoral surface with metal synthetic substitute, open approach. 0SP909Z ...... Removal of proach. Removal of proach. Removal of proach. Removal of proach. Removal of proach. 0SP909Z ...... 0SP909Z ...... 0SP909Z ...... 0SP909Z ...... 0SP909Z ...... 0SP909Z ...... 0SP909Z ...... tkelley on DSK3SPTVN1PROD with PROPOSALS2 0SP909Z ...... VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00059 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 24382 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND 468: PROPOSED NEW HIP REVISION ICD–10–PCS COMBINATIONS—Continued ICD–10–PCS code Code description ICD–10–PCS code Code description 0SP909Z ...... Removal of liner from right hip joint, open approach. and 0SRR039 ..... Removal of liner from right hip joint, open approach. and 0SRR03A .... Removal of liner from right hip joint, open approach. Removal of liner from right hip joint, open approach. Removal of liner from right hip joint, open approach. and 0SRR03Z .... and 0SRR0J9 ..... and 0SRR0JA .... Removal of liner from proach. Removal of liner from proach. Removal of liner from proach. Removal of liner from proach. Removal of resurfacing open approach. Removal of resurfacing open approach. Removal of resurfacing open approach. Removal of resurfacing open approach. right hip joint, open ap- and 0SRR0JZ ..... right hip joint, open ap- and 0SU909Z ..... right hip joint, open ap- and 0SUA09Z ..... right hip joint, open ap- and 0SUR09Z .... device from right hip joint, and 0SR9019 ..... device from right hip joint, and 0SR901A ..... device from right hip joint, and 0SR901Z ..... device from right hip joint, and 0SR9029 ..... 0SP90BZ ..... Removal of resurfacing device from right hip joint, open approach. and 0SR902A ..... 0SP90BZ ..... Removal of resurfacing open approach. Removal of resurfacing open approach. Removal of resurfacing open approach. Removal of resurfacing open approach. Removal of resurfacing open approach. device from right hip joint, and 0SR902Z ..... device from right hip joint, and 0SR9039 ..... device from right hip joint, and 0SR903A ..... device from right hip joint, and 0SR903Z ..... device from right hip joint, and 0SR9049 ..... 0SP90BZ ..... Removal of resurfacing device from right hip joint, open approach. and 0SR904A ..... 0SP90BZ ..... Removal of resurfacing open approach. Removal of resurfacing open approach. Removal of resurfacing open approach. Removal of resurfacing open approach. Removal of resurfacing open approach. device from right hip joint, and 0SR904Z ..... device from right hip joint, and 0SR90J9 ..... device from right hip joint, and 0SR90JA ..... device from right hip joint, and 0SR90JZ ..... device from right hip joint, and 0SRA009 ..... 0SP90BZ ..... Removal of resurfacing device from right hip joint, open approach. and 0SRA00A .... 0SP90BZ ..... Removal of resurfacing device from right hip joint, open approach. and 0SRA00Z ..... 0SP90BZ ..... Removal of resurfacing device from right hip joint, open approach. and 0SRA019 ..... 0SP90BZ ..... Removal of resurfacing device from right hip joint, open approach. and 0SRA01A .... Replacement of right hip joint, femoral surface with ceramic synthetic substitute, cemented, open approach. Replacement of right hip joint, femoral surface with ceramic synthetic substitute, uncemented, open approach. Replacement of right hip joint, femoral surface with ceramic synthetic substitute, open approach. Replacement of right hip joint, femoral surface with synthetic substitute, cemented, open approach. Replacement of right hip joint, femoral surface with synthetic substitute, uncemented, open approach. Replacement of right hip joint, femoral surface with synthetic substitute, open approach. Supplement right hip joint with liner, open approach. Supplement right hip joint, acetabular surface with liner, open approach. Supplement right hip joint, femoral surface with liner, open approach. Replacement of right hip joint with metal synthetic substitute, cemented, open approach. Replacement of right hip joint with metal synthetic substitute, uncemented, open approach. Replacement of right hip joint with metal synthetic substitute, open approach. Replacement of right hip joint with metal on polyethylene synthetic substitute, cemented, open approach. Replacement of right hip joint with metal on polyethylene synthetic substitute, uncemented, open approach. Replacement of right hip joint with metal on polyethylene synthetic substitute, open approach. Replacement of right hip joint with ceramic synthetic substitute, cemented, open approach. Replacement of right hip joint with ceramic synthetic substitute, uncemented, open approach. Replacement of right hip joint with ceramic synthetic substitute, open approach. Replacement of right hip joint with ceramic on polyethylene synthetic substitute, cemented, open approach. Replacement of right hip joint with ceramic on polyethylene synthetic substitute, uncemented, open approach. Replacement of right hip joint with ceramic on polyethylene synthetic substitute, open approach. Replacement of right hip joint with synthetic substitute, cemented, open approach. Replacement of right hip joint with synthetic substitute, uncemented, open approach. Replacement of right hip joint with synthetic substitute, open approach. Replacement of right hip joint, acetabular surface with polyethylene synthetic substitute, cemented, open approach. Replacement of right hip joint, acetabular surface with polyethylene synthetic substitute, uncemented, open approach. Replacement of right hip joint, acetabular surface with polyethylene synthetic substitute, open approach. Replacement of right hip joint, acetabular surface with metal synthetic substitute, cemented, open approach. Replacement of right hip joint, acetabular surface with metal synthetic substitute, uncemented, open approach. 0SP909Z ...... 0SP909Z ...... 0SP909Z ...... 0SP909Z ...... 0SP909Z ...... 0SP909Z ...... 0SP909Z ...... 0SP909Z ...... 0SP90BZ ..... 0SP90BZ ..... 0SP90BZ ..... 0SP90BZ ..... 0SP90BZ ..... 0SP90BZ ..... 0SP90BZ ..... 0SP90BZ ..... 0SP90BZ ..... 0SP90BZ ..... 0SP90BZ ..... tkelley on DSK3SPTVN1PROD with PROPOSALS2 0SP90BZ ..... VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00060 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 24383 MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND 468: PROPOSED NEW HIP REVISION ICD–10–PCS COMBINATIONS—Continued ICD–10–PCS code Code description ICD–10–PCS code Code description 0SP90BZ ..... 0SP90BZ ..... Removal of resurfacing device from right hip joint, open approach. Removal of resurfacing device from right hip joint, open approach. and 0SRA01Z ..... and 0SRA039 ..... Removal of resurfacing device from right hip joint, open approach. and 0SRA03A .... 0SP90BZ ..... Removal of resurfacing device from right hip joint, open approach. and 0SRA03Z ..... 0SP90BZ ..... Removal of resurfacing device from right hip joint, open approach. and 0SRA0J9 ..... 0SP90BZ ..... Removal of resurfacing device from right hip joint, open approach. and 0SRA0JA ..... 0SP90BZ ..... and 0SRA0JZ ..... 0SP90BZ ..... Removal of resurfacing device from right hip joint, open approach. Removal of resurfacing device from right hip joint, open approach. and 0SRR019 ..... 0SP90BZ ..... Removal of resurfacing device from right hip joint, open approach. and 0SRR01A .... 0SP90BZ ..... and 0SRR01Z .... 0SP90BZ ..... Removal of resurfacing device from right hip joint, open approach. Removal of resurfacing device from right hip joint, open approach. and 0SRR039 ..... 0SP90BZ ..... Removal of resurfacing device from right hip joint, open approach. and 0SRR03A .... 0SP90BZ ..... Removal of resurfacing device from right hip joint, open approach. Removal of resurfacing device from right hip joint, open approach. Removal of resurfacing device from right hip joint, open approach. and 0SRR03Z .... and 0SRR0J9 ..... and 0SRR0JA .... Removal of resurfacing device from right open approach. Removal of resurfacing device from right open approach. Removal of resurfacing device from right open approach. Removal of resurfacing device from right open approach. Removal of synthetic substitute from right open approach. hip joint, and 0SRR0JZ ..... hip joint, and 0SU909Z ..... hip joint, and 0SUA09Z ..... hip joint, and 0SUR09Z .... hip joint, and 0SR9049 ..... 0SP90JZ ...... Removal of synthetic substitute from right hip joint, open approach. and 0SR904A ..... 0SP90JZ ...... Removal of synthetic substitute from right hip open approach. Removal of spacer from right hip percutaneous endoscopic approach. Removal of spacer from right hip percutaneous endoscopic approach. Removal of spacer from right hip percutaneous endoscopic approach. Removal of spacer from right hip percutaneous endoscopic approach. joint, and 0SR904Z ..... joint, and 0SR9019 ..... joint, and 0SR901A ..... joint, and 0SR901Z ..... joint, and 0SR9029 ..... Replacement of right hip joint, acetabular surface with metal synthetic substitute, open approach. Replacement of right hip joint, acetabular surface with ceramic synthetic substitute, cemented, open approach. Replacement of right hip joint, acetabular surface with ceramic synthetic substitute, uncemented, open approach. Replacement of right hip joint, acetabular surface with ceramic synthetic substitute, open approach. Replacement of right hip joint, acetabular surface with synthetic substitute, cemented, open approach. Replacement of right hip joint, acetabular surface with synthetic substitute, uncemented, open approach. Replacement of right hip joint, acetabular Surface with synthetic substitute, open approach. Replacement of right hip joint, femoral surface with metal synthetic substitute, cemented, open approach. Replacement of right hip joint, femoral surface with metal synthetic substitute, uncemented, open approach. Replacement of right hip joint, femoral surface with metal synthetic substitute, open approach. Replacement of right hip joint, femoral surface with ceramic synthetic substitute, cemented, open approach. Replacement of right hip joint, femoral surface with ceramic synthetic substitute, uncemented, open approach. Replacement of right hip joint, femoral surface with ceramic synthetic substitute, open approach. Replacement of right hip joint, femoral surface with synthetic substitute, cemented, open approach. Replacement of right hip joint, femoral surface with synthetic substitute, uncemented, open approach. Replacement of right hip joint, femoral surface with synthetic substitute, open approach. Supplement right hip joint with liner, open approach. Supplement right hip joint, acetabular surface with liner, open approach. Supplement right hip joint, femoral surface with liner, open approach. Replacement of right hip joint with ceramic on polyethylene synthetic substitute, cemented, open approach. Replacement of right hip joint with ceramic on polyethylene synthetic substitute, uncemented, open approach. Replacement of right hip joint with ceramic on polyethylene synthetic substitute, open approach. Replacement of right hip joint with metal synthetic substitute, cemented, open approach. Replacement of right hip joint with metal synthetic substitute, uncemented, open approach. Replacement of right hip joint with metal synthetic substitute, open approach. Replacement of right hip joint with metal on polyethylene synthetic substitute, cemented, open approach. Replacement of right hip joint with metal on polyethylene synthetic substitute, uncemented, open approach. Replacement of right hip joint with metal on polyethylene synthetic substitute, open approach. 0SP90BZ ..... 0SP90BZ ..... 0SP90BZ ..... 0SP90BZ ..... 0SP90BZ ..... 0SP90BZ ..... 0SP90BZ ..... 0SP90JZ ...... 0SP948Z ...... tkelley on DSK3SPTVN1PROD with PROPOSALS2 0SP948Z ...... 0SP948Z ...... 0SP948Z ...... 0SP948Z ...... Removal of spacer from right hip percutaneous endoscopic approach. joint, and 0SR902A ..... 0SP948Z ...... Removal of spacer from right hip percutaneous endoscopic approach. joint, and 0SR902Z ..... VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00061 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 24384 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND 468: PROPOSED NEW HIP REVISION ICD–10–PCS COMBINATIONS—Continued ICD–10–PCS code 0SP948Z ...... ICD–10–PCS code Code description joint, and 0SR9039 ..... hip joint, and 0SR903A ..... hip joint, and 0SR903Z ..... hip joint, and 0SR9049 ..... 0SP948Z ...... Removal of spacer from right hip percutaneous endoscopic approach. joint, and 0SR904A ..... 0SP948Z ...... Removal of percutaneous Removal of percutaneous Removal of percutaneous Removal of percutaneous Removal of percutaneous hip joint, and 0SR904Z ..... hip joint, and 0SR90J9 ..... hip joint, and 0SR90JA ..... hip joint, and 0SR90JZ ..... hip joint, and 0SRA009 ..... 0SP948Z ...... Removal of spacer from right hip percutaneous endoscopic approach. joint, and 0SRA00A .... 0SP948Z ...... Removal of spacer from right hip percutaneous endoscopic approach. joint, and 0SRA00Z ..... 0SP948Z ...... Removal of spacer from right hip percutaneous endoscopic approach. joint, and 0SRA019 ..... 0SP948Z ...... Removal of spacer from right hip percutaneous endoscopic approach. joint, and 0SRA01A .... 0SP948Z ...... spacer from right hip endoscopic approach. spacer from right hip endoscopic approach. joint, and 0SRA01Z ..... 0SP948Z ...... Removal of percutaneous Removal of percutaneous joint, and 0SRA039 ..... 0SP948Z ...... Removal of spacer from right hip percutaneous endoscopic approach. joint, and 0SRA03A .... 0SP948Z ...... Removal of spacer from right hip percutaneous endoscopic approach. joint, and 0SRA03Z ..... 0SP948Z ...... Removal of spacer from right hip percutaneous endoscopic approach. joint, and 0SRA0J9 ..... 0SP948Z ...... Removal of spacer from right hip percutaneous endoscopic approach. joint, and 0SRA0JA ..... 0SP948Z ...... spacer from right hip endoscopic approach. spacer from right hip endoscopic approach. joint, and 0SRA0JZ ..... 0SP948Z ...... Removal of percutaneous Removal of percutaneous joint, and 0SRR019 ..... 0SP948Z ...... Removal of spacer from right hip percutaneous endoscopic approach. joint, and 0SRR01A .... 0SP948Z ...... spacer from right hip endoscopic approach. spacer from right hip endoscopic approach. joint, and 0SRR01Z .... 0SP948Z ...... Removal of percutaneous Removal of percutaneous joint, and 0SRR039 ..... 0SP948Z ...... Removal of spacer from right hip percutaneous endoscopic approach. joint, and 0SRR03A .... 0SP948Z ...... 0SP948Z ...... 0SP948Z ...... 0SP948Z ...... 0SP948Z ...... tkelley on DSK3SPTVN1PROD with PROPOSALS2 0SP948Z ...... VerDate Sep<11>2014 18:20 Apr 29, 2015 spacer from right endoscopic approach. spacer from right endoscopic approach. spacer from right endoscopic approach. spacer from right endoscopic approach. Replacement of right hip joint with ceramic synthetic substitute, cemented, open approach. Replacement of right hip joint with ceramic synthetic substitute, uncemented, open approach. Replacement of right hip joint with ceramic synthetic substitute, open approach. Replacement of right hip joint with ceramic on polyethylene synthetic substitute, cemented, open approach. Replacement of right hip joint with ceramic on polyethylene synthetic substitute, uncemented, open approach. Replacement of right hip joint with ceramic on polyethylene synthetic substitute, open approach. Replacement of right hip joint with synthetic substitute, cemented, open approach. Replacement of right hip joint with synthetic substitute, uncemented, open approach. Replacement of right hip joint with synthetic substitute, open approach. Replacement of right hip joint, acetabular surface with polyethylene synthetic substitute, cemented, open approach. Replacement of right hip joint, acetabular surface with polyethylene synthetic substitute, uncemented, open approach. Replacement of right hip joint, acetabular surface with polyethylene synthetic substitute, open approach. Replacement of right hip joint, acetabular surface with metal synthetic substitute, cemented, open approach. Replacement of right hip joint, acetabular Surface with metal synthetic substitute, uncemented, open approach. Replacement of right hip joint, acetabular surface with metal synthetic substitute, open approach. Replacement of right hip joint, acetabular surface with ceramic synthetic substitute, cemented, open approach. Replacement of right hip joint, acetabular surface with ceramic synthetic substitute, uncemented, open approach. Replacement of right hip joint, acetabular surface with ceramic synthetic substitute, open approach. Replacement of right hip joint, acetabular surface with synthetic substitute, cemented, open approach. Replacement of right hip joint, acetabular surface with synthetic substitute, uncemented, open approach. Replacement of right hip joint, acetabular surface with synthetic substitute, open approach. Replacement of right hip joint, femoral surface with metal synthetic substitute, cemented, open approach. Replacement of right hip joint, femoral surface with metal synthetic substitute, uncemented, open approach. Replacement of right hip joint, femoral surface with metal synthetic substitute, open approach. Replacement of right hip joint, femoral surface with ceramic synthetic substitute, cemented, open approach. Replacement of right hip joint, femoral surface with ceramic synthetic substitute, uncemented, open approach. hip 0SP948Z ...... Removal of percutaneous Removal of percutaneous Removal of percutaneous Removal of percutaneous Code description spacer from right endoscopic approach. spacer from right endoscopic approach. spacer from right endoscopic approach. spacer from right endoscopic approach. spacer from right endoscopic approach. Jkt 235001 PO 00000 Frm 00062 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 24385 MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND 468: PROPOSED NEW HIP REVISION ICD–10–PCS COMBINATIONS—Continued ICD–10–PCS code 0SP948Z ...... ICD–10–PCS code Code description and 0SRR03Z .... joint, and 0SRR0J9 ..... joint, and 0SRR0JA .... joint, and 0SRR0JZ ..... joint, and 0SU909Z ..... joint, and 0SUA09Z ..... joint, and 0SUR09Z .... joint, and 0SR9019 ..... joint, and 0SR901A ..... joint, and 0SR901Z ..... joint, and 0SR9029 ..... 0SP94JZ ...... Removal of synthetic substitute from right hip joint, percutaneous endoscopic approach. and 0SR902A ..... 0SP94JZ ...... Removal of synthetic substitute from right percutaneous endoscopic approach. Removal of synthetic substitute from right percutaneous endoscopic approach. Removal of synthetic substitute from right percutaneous endoscopic approach. Removal of synthetic substitute from right percutaneous endoscopic approach. Removal of synthetic substitute from right percutaneous endoscopic approach. hip joint, and 0SR902Z ..... hip joint, and 0SR9039 ..... hip joint, and 0SR903A ..... hip joint, and 0SR903Z ..... hip joint, and 0SR9049 ..... 0SP94JZ ...... Removal of synthetic substitute from right hip joint, percutaneous endoscopic approach. and 0SR904A ..... 0SP94JZ ...... Removal of synthetic substitute from right percutaneous endoscopic approach. Removal of synthetic substitute from right percutaneous endoscopic approach. Removal of synthetic substitute from right percutaneous endoscopic approach. Removal of synthetic substitute from right percutaneous endoscopic approach. Removal of synthetic substitute from right percutaneous endoscopic approach. hip joint, and 0SR904Z ..... hip joint, and 0SR90J9 ..... hip joint, and 0SR90JA ..... hip joint, and 0SR90JZ ..... hip joint, and 0SRA009 ..... 0SP94JZ ...... Removal of synthetic substitute from right hip joint, percutaneous endoscopic approach. and 0SRA00A .... 0SP94JZ ...... Removal of synthetic substitute from right hip joint, percutaneous endoscopic approach. and 0SRA00Z ..... 0SP94JZ ...... Removal of synthetic substitute from right hip joint, percutaneous endoscopic approach. and 0SRA019 ..... 0SP94JZ ...... Removal of synthetic substitute from right hip joint, percutaneous endoscopic approach. and 0SRA01A .... 0SP94JZ ...... Removal of synthetic substitute from right hip joint, percutaneous endoscopic approach. Removal of synthetic substitute from right hip joint, percutaneous endoscopic approach. and 0SRA01Z ..... and 0SRA039 ..... 0SP948Z ...... 0SP948Z ...... 0SP948Z ...... 0SP948Z ...... 0SP948Z ...... 0SP94JZ ...... 0SP94JZ ...... 0SP94JZ ...... 0SP94JZ ...... 0SP94JZ ...... 0SP94JZ ...... 0SP94JZ ...... 0SP94JZ ...... 0SP94JZ ...... 0SP94JZ ...... 0SP94JZ ...... tkelley on DSK3SPTVN1PROD with PROPOSALS2 0SP94JZ ...... 0SP94JZ ...... VerDate Sep<11>2014 spacer from right hip endoscopic approach. spacer from right hip endoscopic approach. spacer from right hip endoscopic approach. Replacement of right hip joint, femoral surface with ceramic synthetic substitute, open approach. Replacement of right hip joint, femoral surface with synthetic substitute, cemented, open approach. Replacement of right hip joint, femoral surface with synthetic substitute, uncemented, open approach. Replacement of right hip joint, femoral surface with synthetic substitute, open approach. Supplement right hip joint with liner, open approach. Supplement right hip joint, acetabular surface with liner, open approach. Supplement right hip joint, femoral surface with liner, open approach. Replacement of right hip joint with metal synthetic substitute, cemented, open approach. Replacement of right hip joint with metal synthetic substitute, uncemented, open approach. Replacement of right hip joint with metal synthetic substitute, open approach. Replacement of right hip joint with metal on polyethylene synthetic substitute, cemented, open approach. Replacement of right hip joint with metal on polyethylene synthetic substitute, uncemented, open approach. Replacement of right hip joint with metal on polyethylene synthetic substitute, open approach. Replacement of right hip joint with ceramic synthetic substitute, cemented, open approach. Replacement of right hip joint with ceramic synthetic substitute, uncemented, open approach. Replacement of right hip joint with ceramic synthetic substitute, open approach. Replacement of right hip joint with ceramic on polyethylene synthetic substitute, cemented, open approach. Replacement of right hip joint with ceramic on polyethylene synthetic substitute, uncemented, open approach. Replacement of right hip joint with ceramic on polyethylene synthetic substitute, open approach. Replacement of right hip joint with synthetic substitute, cemented, open approach. Replacement of right hip joint with synthetic substitute, uncemented, open approach. Replacement of right hip joint with synthetic substitute, open approach. Replacement of right hip joint, acetabular surface with polyethylene synthetic substitute, cemented, open approach. Replacement of right hip joint, acetabular surface with polyethylene synthetic substitute, uncemented, open approach. Replacement of right hip joint, acetabular surface with polyethylene synthetic substitute, open approach. Replacement of right hip joint, acetabular surface with metal synthetic substitute, cemented, open approach. Replacement of right hip joint, acetabular surface with metal synthetic substitute, uncemented, open approach. Replacement of right hip joint, acetabular surface with metal synthetic substitute, open approach. Replacement of right hip joint, acetabular surface with ceramic synthetic substitute, cemented, open approach. joint, 0SP948Z ...... Removal of percutaneous Removal of percutaneous Removal of percutaneous Code description Removal of spacer from right hip percutaneous endoscopic approach. Removal of spacer from right hip percutaneous endoscopic approach. Removal of spacer from right hip percutaneous endoscopic approach. Removal of spacer from right hip percutaneous endoscopic approach. Removal of synthetic substitute from right hip percutaneous endoscopic approach. Removal of synthetic substitute from right hip percutaneous endoscopic approach. Removal of synthetic substitute from right hip percutaneous endoscopic approach. Removal of synthetic substitute from right hip percutaneous endoscopic approach. 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00063 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 24386 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND 468: PROPOSED NEW HIP REVISION ICD–10–PCS COMBINATIONS—Continued ICD–10–PCS code Code description ICD–10–PCS code Code description 0SP94JZ ...... Removal of synthetic substitute from right hip joint, percutaneous endoscopic approach. and 0SRA03A .... Removal of synthetic substitute from right hip joint, percutaneous endoscopic approach. and 0SRA03Z ..... 0SP94JZ ...... Removal of synthetic substitute from right hip joint, percutaneous endoscopic approach. and 0SRA0J9 ..... 0SP94JZ ...... Removal of synthetic substitute from right hip joint, percutaneous endoscopic approach. and 0SRA0JA ..... 0SP94JZ ...... and 0SRA0JZ ..... 0SP94JZ ...... Removal of synthetic substitute from right hip joint, percutaneous endoscopic approach. Removal of synthetic substitute from right hip joint, percutaneous endoscopic approach. and 0SRR019 ..... 0SP94JZ ...... Removal of synthetic substitute from right hip joint, percutaneous endoscopic approach. and 0SRR01A .... 0SP94JZ ...... and 0SRR01Z .... 0SP94JZ ...... Removal of synthetic substitute from right hip joint, percutaneous endoscopic approach. Removal of synthetic substitute from right hip joint, percutaneous endoscopic approach. and 0SRR039 ..... 0SP94JZ ...... Removal of synthetic substitute from right hip joint, percutaneous endoscopic approach. and 0SRR03A .... 0SP94JZ ...... Removal of synthetic substitute from right hip joint, percutaneous endoscopic approach. Removal of synthetic substitute from right hip joint, percutaneous endoscopic approach. Removal of synthetic substitute from right hip joint, percutaneous endoscopic approach. and 0SRR03Z .... and 0SRR0J9 ..... and 0SRR0JA .... Removal of synthetic substitute from right hip joint, percutaneous endoscopic approach. Removal of synthetic substitute from right hip joint, percutaneous endoscopic approach. Removal of synthetic substitute from right hip joint, percutaneous endoscopic approach. Removal of synthetic substitute from right hip joint, percutaneous endoscopic approach. Removal of spacer from left hip joint, open approach. Removal of spacer from left hip joint, open approach. Removal of spacer from left hip joint, open approach. Removal of spacer from left hip joint, open approach. and 0SRR0JZ ..... and 0SU909Z ..... and 0SUA09Z ..... and 0SUR09Z .... and 0SRB019 ..... and 0SRB01A .... and 0SRB01Z ..... and 0SRB029 ..... 0SPB08Z ..... Removal of spacer from left hip joint, open approach. and 0SRB02A .... 0SPB08Z ..... Removal of proach. Removal of proach. Removal of proach. Removal of proach. Removal of proach. spacer from left hip joint, open ap- and 0SRB02Z ..... spacer from left hip joint, open ap- and 0SRB039 ..... spacer from left hip joint, open ap- and 0SRB03A .... spacer from left hip joint, open ap- and 0SRB03Z ..... spacer from left hip joint, open ap- and 0SRB049 ..... Removal of spacer from left hip joint, open approach. and 0SRB04A .... Replacement of right hip joint, acetabular surface with ceramic synthetic substitute, uncemented, open approach. Replacement of right hip joint, acetabular surface with ceramic synthetic substitute, open approach. Replacement of right hip joint, acetabular surface with synthetic substitute, cemented, open approach. Replacement of right hip joint, acetabular surface with synthetic substitute, uncemented, open approach. Replacement of right hip joint, acetabular surface with synthetic substitute, open approach. Replacement of right hip joint, femoral surface with metal synthetic substitute, cemented, open approach. Replacement of right hip joint, femoral surface with metal synthetic substitute, uncemented, open approach. Replacement of right hip joint, femoral surface with metal synthetic substitute, open approach. Replacement of right hip joint, femoral surface with ceramic synthetic substitute, cemented, open approach. Replacement of right hip joint, femoral surface with ceramic synthetic substitute, uncemented, open approach. Replacement of right hip joint, femoral surface with ceramic synthetic substitute, open approach. Replacement of right hip joint, femoral surface with synthetic substitute, cemented, open approach. Replacement of right hip joint, femoral surface with synthetic substitute, uncemented, open approach. Replacement of right hip joint, femoral surface with synthetic substitute, open approach. Supplement right hip joint with liner, open approach. Supplement right hip joint, acetabular surface with liner, open approach. Supplement right hip joint, femoral surface with liner, open approach. Replacement of left hip joint with metal synthetic substitute, cemented, open approach. Replacement of left hip joint with metal synthetic substitute, uncemented, open approach. Replacement of left hip joint with metal synthetic substitute, open approach. Replacement of left hip joint with metal on polyethylene synthetic substitute, cemented, open approach. Replacement of left hip joint with metal on polyethylene synthetic substitute, uncemented, open approach. Replacement of left hip joint with metal on polyethylene synthetic substitute, open approach. Replacement of left hip joint with ceramic synthetic substitute, cemented, open approach. Replacement of left hip joint with ceramic synthetic substitute, uncemented, open approach. Replacement of left hip joint with ceramic synthetic substitute, open approach. Replacement of left hip joint with ceramic on polyethylene synthetic substitute, cemented, open approach. Replacement of left hip joint with ceramic on polyethylene synthetic substitute, uncemented, open approach. 0SP94JZ ...... 0SP94JZ ...... 0SP94JZ ...... 0SP94JZ ...... 0SP94JZ ...... 0SP94JZ ...... 0SP94JZ ...... 0SPB08Z ..... 0SPB08Z ..... 0SPB08Z ..... 0SPB08Z ..... 0SPB08Z ..... tkelley on DSK3SPTVN1PROD with PROPOSALS2 0SPB08Z ..... 0SPB08Z ..... 0SPB08Z ..... 0SPB08Z ..... VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00064 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 24387 MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND 468: PROPOSED NEW HIP REVISION ICD–10–PCS COMBINATIONS—Continued ICD–10–PCS code 0SPB08Z ..... ICD–10–PCS code Code description Replacement of left hip joint with ceramic on polyethylene synthetic substitute, open approach. Replacement of left hip joint with synthetic substitute, cemented, open approach. Replacement of left hip joint with synthetic substitute, uncemented, open approach. Replacement of left hip joint with synthetic substitute, open approach. Replacement of left hip joint, acetabular surface with polyethylene synthetic substitute, cemented, open approach. Replacement of left hip joint, acetabular surface with polyethylene synthetic substitute, uncemented, open approach. Replacement of left hip joint, acetabular surface with polyethylene synthetic substitute, open approach. Replacement of left hip joint, acetabular surface with metal synthetic substitute, cemented, open approach. Replacement of left hip joint, acetabular surface with metal synthetic substitute, uncemented, open approach. Replacement of left hip joint, acetabular surface with metal synthetic substitute, open approach. Replacement of left hip joint, acetabular surface with ceramic synthetic substitute, cemented, open approach. Replacement of left hip joint, acetabular surface with ceramic synthetic substitute, uncemented, open approach. Replacement of left hip joint, acetabular surface with ceramic synthetic substitute, open approach. Replacement of left hip joint, acetabular surface with synthetic substitute, cemented, open approach. Replacement of left hip joint, acetabular surface with synthetic substitute, uncemented, open approach. Replacement of left hip joint, acetabular surface with synthetic substitute, open approach. Replacement of left hip joint, femoral surface with metal synthetic substitute, cemented, open approach. Replacement of left hip joint, femoral surface with metal synthetic substitute, uncemented, open approach. Replacement of left hip joint, femoral surface with metal synthetic substitute, open approach. Replacement of left hip joint, femoral surface with ceramic synthetic substitute, cemented, open approach. Replacement of left hip joint, femoral surface with ceramic synthetic substitute, uncemented, open approach. Replacement of left hip joint, femoral surface with ceramic synthetic substitute, open approach. Replacement of left hip joint, femoral surface with synthetic substitute, cemented, open approach. Replacement of left hip joint, femoral surface with synthetic substitute, uncemented, open approach. Replacement of left hip joint, femoral surface with synthetic substitute, open approach. Supplement left hip joint with liner, open approach. spacer from left hip joint, open ap- and 0SRB04Z ..... spacer from left hip joint, open ap- and 0SRB0J9 ..... spacer from left hip joint, open ap- and 0SRB0JA ..... spacer from left hip joint, open ap- and 0SRB0JZ ..... spacer from left hip joint, open ap- and 0SRE009 ..... 0SPB08Z ..... Removal of spacer from left hip joint, open approach. and 0SRE00A .... 0SPB08Z ..... Removal of spacer from left hip joint, open approach. and 0SRE00Z ..... 0SPB08Z ..... Removal of spacer from left hip joint, open approach. and 0SRE019 ..... 0SPB08Z ..... Removal of spacer from left hip joint, open approach. and 0SRE01A .... 0SPB08Z ..... and 0SRE01Z ..... 0SPB08Z ..... Removal of spacer from left hip joint, open approach. Removal of spacer from left hip joint, open approach. and 0SRE039 ..... 0SPB08Z ..... Removal of spacer from left hip joint, open approach. and 0SRE03A .... 0SPB08Z ..... Removal of spacer from left hip joint, open approach. and 0SRE03Z ..... 0SPB08Z ..... Removal of spacer from left hip joint, open approach. and 0SRE0J9 ..... 0SPB08Z ..... Removal of spacer from left hip joint, open approach. and 0SRE0JA ..... 0SPB08Z ..... and 0SRE0JZ ..... 0SPB08Z ..... Removal of spacer from left hip joint, open approach. Removal of spacer from left hip joint, open approach. and 0SRS019 ..... 0SPB08Z ..... Removal of spacer from left hip joint, open approach. and 0SRS01A .... 0SPB08Z ..... and 0SRS01Z ..... 0SPB08Z ..... Removal of spacer from left hip joint, open approach. Removal of spacer from left hip joint, open approach. and 0SRS039 ..... 0SPB08Z ..... Removal of spacer from left hip joint, open approach. and 0SRS03A .... 0SPB08Z ..... Removal of spacer from left hip joint, open approach. Removal of spacer from left hip joint, open approach. Removal of spacer from left hip joint, open approach. and 0SRS03Z ..... and 0SRS0J9 ..... and 0SRS0JA ..... Removal of spacer from left hip joint, open approach. Removal of spacer from left hip joint, open approach. Removal of spacer from left hip joint, open approach. and 0SRS0JZ ..... and 0SUB09Z ..... and 0SUE09Z ..... 0SPB08Z ..... 0SPB08Z ..... 0SPB08Z ..... 0SPB08Z ..... tkelley on DSK3SPTVN1PROD with PROPOSALS2 0SPB08Z ..... 0SPB08Z ..... 0SPB08Z ..... 0SPB08Z ..... 0SPB08Z ..... VerDate Sep<11>2014 Removal of proach. Removal of proach. Removal of proach. Removal of proach. Removal of proach. Code description 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00065 Fmt 4701 Sfmt 4702 Supplement left hip joint, acetabular surface with liner, open approach. E:\FR\FM\30APP2.SGM 30APP2 24388 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND 468: PROPOSED NEW HIP REVISION ICD–10–PCS COMBINATIONS—Continued Code description 0SPB08Z ..... 0SPB09Z ..... Removal of spacer from left hip joint, open approach. Removal of liner from left hip joint, open approach 0SPB09Z ..... ICD–10–PCS code Code description and 0SUS09Z ..... and 0SRB019 ..... Removal of liner from left hip joint, open approach and 0SRB01A .... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRB01Z ..... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRB029 ..... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRB02A .... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRB02Z ..... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRB039 ..... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRB03A .... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRB03Z ..... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRB049 ..... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRB04A .... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRB04Z ..... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRB0J9 ..... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRB0JA ..... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRB0JZ ..... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRE009 ..... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRE00A .... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRE00Z ..... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRE019 ..... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRE01A .... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRE01Z ..... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRE039 ..... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRE03A .... 0SPB09Z ..... tkelley on DSK3SPTVN1PROD with PROPOSALS2 ICD–10–PCS code Removal of liner from left hip joint, open approach and 0SRE03Z ..... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRE0J9 ..... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRE0JA ..... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRE0JZ ..... Supplement left hip joint, femoral surface with liner, open approach. Replacement of left hip joint with metal synthetic substitute, cemented, open approach. Replacement of left hip joint with metal synthetic substitute, uncemented, open approach. Replacement of left hip joint with metal synthetic substitute, open approach. Replacement of left hip joint with metal on polyethylene synthetic substitute, cemented, open approach. Replacement of left hip joint with metal on polyethylene synthetic substitute, uncemented, open approach. Replacement of left hip joint with metal on polyethylene synthetic substitute, open approach. Replacement of left hip joint with ceramic synthetic substitute, cemented, open approach. Replacement of left hip joint with ceramic synthetic substitute, uncemented, open approach. Replacement of left hip joint with ceramic synthetic substitute, open approach. Replacement of left hip joint with ceramic on polyethylene synthetic substitute, cemented, open approach. Replacement of left hip joint with ceramic on polyethylene synthetic substitute, uncemented, open approach. Replacement of left hip joint with ceramic on polyethylene synthetic substitute, open approach. Replacement of left hip joint with synthetic substitute, cemented, open approach. Replacement of left hip joint with synthetic substitute, uncemented, open approach. Replacement of left hip joint with synthetic substitute, open approach. Replacement of left hip joint, acetabular surface with polyethylene synthetic substitute, cemented, open approach. Replacement of left hip joint, acetabular surface with polyethylene synthetic substitute, uncemented, open approach. Replacement of left hip joint, acetabular surface with polyethylene synthetic substitute, open approach. Replacement of left hip joint, acetabular surface with metal synthetic substitute, cemented, open approach. Replacement of left hip joint, acetabular surface with metal synthetic substitute, uncemented, open approach. Replacement of left hip joint, acetabular surface with metal synthetic substitute, open approach. Replacement of left hip joint, acetabular surface with ceramic synthetic substitute, cemented, open approach. Replacement of left hip joint, acetabular surface with ceramic synthetic substitute, uncemented, open approach. Replacement of left hip joint, acetabular surface with ceramic synthetic substitute, open approach. Replacement of left hip joint, acetabular surface with synthetic substitute, cemented, open approach. Replacement of left hip joint, acetabular surface with synthetic substitute, uncemented, open approach. Replacement of left hip joint, acetabular surface with synthetic substitute, open approach. VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00066 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 24389 MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND 468: PROPOSED NEW HIP REVISION ICD–10–PCS COMBINATIONS—Continued ICD–10–PCS code Code description ICD–10–PCS code Code description 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRS019 ..... Removal of liner from left hip joint, open approach and 0SRS01A .... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRS01Z ..... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRS039 ..... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRS03A .... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRS03Z ..... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRS0J9 ..... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRS0JA ..... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SRS0JZ ..... 0SPB09Z ..... 0SPB09Z ..... Removal of liner from left hip joint, open approach Removal of liner from left hip joint, open approach and and 0SUB09Z ..... 0SUE09Z ..... 0SPB09Z ..... Removal of liner from left hip joint, open approach and 0SUS09Z ..... 0SPB0BZ ..... Removal of resurfacing open approach. Removal of resurfacing open approach. Removal of resurfacing open approach. Removal of resurfacing open approach. device from left hip joint, and 0SRB019 ..... device from left hip joint, and 0SRB01A .... device from left hip joint, and 0SRB01Z ..... device from left hip joint, and 0SRB029 ..... 0SPB0BZ ..... Removal of resurfacing device from left hip joint, open approach. and 0SRB02A .... 0SPB0BZ ..... Removal of resurfacing open approach. Removal of resurfacing open approach. Removal of resurfacing open approach. Removal of resurfacing open approach. Removal of resurfacing open approach. device from left hip joint, and 0SRB02Z ..... device from left hip joint, and 0SRB039 ..... device from left hip joint, and 0SRB03A .... device from left hip joint, and 0SRB03Z ..... device from left hip joint, and 0SRB049 ..... 0SPB0BZ ..... Removal of resurfacing device from left hip joint, open approach. and 0SRB04A .... 0SPB0BZ ..... Removal of resurfacing open approach. Removal of resurfacing open approach. Removal of resurfacing open approach. Removal of resurfacing open approach. Removal of resurfacing open approach. device from left hip joint, and 0SRB04Z ..... device from left hip joint, and 0SRB0J9 ..... device from left hip joint, and 0SRB0JA ..... device from left hip joint, and 0SRB0JZ ..... device from left hip joint, and 0SRE009 ..... Removal of resurfacing device from left hip joint, open approach. and 0SRE00A .... Replacement of left hip joint, femoral surface with metal synthetic substitute, cemented, open approach. Replacement of left hip joint, femoral surface with metal synthetic substitute, uncemented, open approach. Replacement of left hip joint, femoral surface with metal synthetic substitute, open approach. Replacement of left hip joint, femoral surface with ceramic synthetic substitute, cemented, open approach. Replacement of left hip joint, femoral surface with ceramic synthetic substitute, uncemented, open approach. Replacement of left hip joint, femoral surface with ceramic synthetic substitute, open approach. Replacement of left hip joint, femoral surface with synthetic substitute, cemented, open approach. Replacement of left hip joint, femoral surface with synthetic substitute, uncemented, open approach. Replacement of left hip joint, femoral surface with synthetic substitute, open approach. Supplement left hip joint with liner, open approach. Supplement left hip joint, acetabular surface with liner, open approach. Supplement left hip joint, femoral surface with liner, open approach. Replacement of left hip joint with metal synthetic substitute, cemented, open approach. Replacement of left hip joint with metal synthetic substitute, uncemented, open approach. Replacement of left hip joint with metal synthetic substitute, open approach. Replacement of left hip joint with metal on polyethylene synthetic substitute, cemented, open approach. Replacement of left hip joint with metal on polyethylene synthetic substitute, uncemented, open approach. Replacement of left hip joint with metal on polyethylene synthetic substitute, open approach. Replacement of left hip joint with ceramic synthetic substitute, cemented, open approach. Replacement of left hip joint with ceramic synthetic substitute, uncemented, open approach. Replacement of left hip joint with ceramic synthetic substitute, open approach. Replacement of left hip joint with ceramic on polyethylene synthetic substitute, cemented, open approach. Replacement of left hip joint with ceramic on polyethylene synthetic substitute, uncemented, open approach. Replacement of left hip joint with ceramic on polyethylene synthetic substitute, open approach. Replacement of left hip joint with synthetic substitute, cemented, open approach. Replacement of left hip joint with synthetic substitute, uncemented, open approach. Replacement of left hip joint with synthetic substitute, open approach. Replacement of left hip joint, acetabular surface with polyethylene synthetic substitute, cemented, open approach. Replacement of left hip joint, acetabular surface with polyethylene synthetic substitute, uncemented, open approach. 0SPB09Z ..... 0SPB0BZ ..... 0SPB0BZ ..... 0SPB0BZ ..... 0SPB0BZ ..... 0SPB0BZ ..... 0SPB0BZ ..... 0SPB0BZ ..... 0SPB0BZ ..... tkelley on DSK3SPTVN1PROD with PROPOSALS2 0SPB0BZ ..... 0SPB0BZ ..... 0SPB0BZ ..... 0SPB0BZ ..... VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00067 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 24390 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND 468: PROPOSED NEW HIP REVISION ICD–10–PCS COMBINATIONS—Continued ICD–10–PCS code Code description ICD–10–PCS code Code description 0SPB0BZ ..... Removal of resurfacing device from left hip joint, open approach. and 0SRE00Z ..... Removal of resurfacing device from left hip joint, open approach. and 0SRE019 ..... 0SPB0BZ ..... Removal of resurfacing device from left hip joint, open approach. and 0SRE01A .... 0SPB0BZ ..... and 0SRE01Z ..... 0SPB0BZ ..... Removal of resurfacing device from left hip joint, open approach. Removal of resurfacing device from left hip joint, open approach. and 0SRE039 ..... 0SPB0BZ ..... Removal of resurfacing device from left hip joint, open approach. and 0SRE03A .... 0SPB0BZ ..... Removal of resurfacing device from left hip joint, open approach. and 0SRE03Z ..... 0SPB0BZ ..... Removal of resurfacing device from left hip joint, open approach. and 0SRE0J9 ..... 0SPB0BZ ..... Removal of resurfacing device from left hip joint, open approach. and 0SRE0JA ..... 0SPB0BZ ..... and 0SRE0JZ ..... 0SPB0BZ ..... Removal of resurfacing device from left hip joint, open approach. Removal of resurfacing device from left hip joint, open approach. and 0SRS019 ..... 0SPB0BZ ..... Removal of resurfacing device from left hip joint, open approach. and 0SRS01A .... 0SPB0BZ ..... and 0SRS01Z ..... 0SPB0BZ ..... Removal of resurfacing device from left hip joint, open approach. Removal of resurfacing device from left hip joint, open approach. and 0SRS039 ..... 0SPB0BZ ..... Removal of resurfacing device from left hip joint, open approach. and 0SRS03A .... 0SPB0BZ ..... Removal of resurfacing device from left hip joint, open approach. Removal of resurfacing device from left hip joint, open approach. Removal of resurfacing device from left hip joint, open approach. and 0SRS03Z ..... and 0SRS0J9 ..... and 0SRS0JA ..... Removal of resurfacing device from open approach. Removal of resurfacing device from open approach. Removal of resurfacing device from open approach. Removal of resurfacing device from open approach. Removal of synthetic substitute from open approach. left hip joint, and 0SRS0JZ ..... left hip joint, and 0SUB09Z ..... Replacement of left hip joint, acetabular surface with polyethylene synthetic substitute, open approach. Replacement of left hip joint, acetabular surface with metal synthetic substitute, cemented, open approach. Replacement of left hip joint, acetabular surface with metal synthetic substitute, uncemented, open approach. Replacement of left hip joint, acetabular surface with metal synthetic substitute, open approach. Replacement of left hip joint, acetabular surface with ceramic synthetic substitute, cemented, open approach. Replacement of left hip joint, acetabular surface with ceramic synthetic substitute, uncemented, open approach. Replacement of left hip joint, acetabular surface with ceramic synthetic substitute, open approach. Replacement of left hip joint, acetabular surface with synthetic substitute, cemented, open approach. Replacement of left hip joint, acetabular surface with synthetic substitute, uncemented, open approach. Replacement of left hip joint, acetabular surface with synthetic substitute, open approach. Replacement of left hip joint, femoral surface with metal synthetic substitute, cemented, open approach. Replacement of left hip joint, femoral surface with metal synthetic substitute, uncemented, open approach. Replacement of left hip joint, femoral surface with metal synthetic substitute, open approach. Replacement of left hip joint, femoral surface with ceramic synthetic substitute, cemented, open approach. Replacement of left hip joint, femoral surface with ceramic synthetic substitute, uncemented, open approach. Replacement of left hip joint, femoral surface with ceramic synthetic substitute, open approach. Replacement of left hip joint, femoral surface with synthetic substitute, cemented, open approach. Replacement of left hip joint, femoral surface with synthetic substitute, uncemented, open approach. Replacement of left hip joint, femoral surface with synthetic substitute, open approach. Supplement left hip joint with liner, open approach. 0SPB0BZ ..... left hip joint, and 0SUE09Z ..... left hip joint, and 0SUS09Z ..... left hip joint, and 0SRB049 ..... 0SPB0JZ ...... Removal of synthetic substitute from left hip joint, open approach. and 0SRB04A .... 0SPB0JZ ...... Removal of synthetic substitute from left hip joint, open approach. Removal of spacer from left hip joint, percutaneous endoscopic approach. Removal of spacer from left hip joint, percutaneous endoscopic approach. and 0SRB04Z ..... and 0SRB019 ..... and 0SRB01A .... 0SPB0BZ ..... 0SPB0BZ ..... 0SPB0BZ ..... 0SPB0BZ ..... 0SPB0BZ ..... 0SPB0BZ ..... tkelley on DSK3SPTVN1PROD with PROPOSALS2 0SPB0JZ ...... 0SPB48Z ..... 0SPB48Z ..... VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00068 Fmt 4701 Sfmt 4702 Supplement left hip joint, acetabular surface with liner, open approach. Supplement left hip joint, femoral surface with liner, open approach. Replacement of left hip joint with ceramic on polyethylene synthetic substitute, cemented, open approach. Replacement of left hip joint with ceramic on polyethylene synthetic substitute, uncemented, open approach. Replacement of left hip joint with ceramic on polyethylene synthetic substitute, open approach. Replacement of left hip joint with metal synthetic substitute, cemented, open approach. Replacement of left hip joint with metal synthetic substitute, uncemented, open approach. E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 24391 MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND 468: PROPOSED NEW HIP REVISION ICD–10–PCS COMBINATIONS—Continued ICD–10–PCS code Code description ICD–10–PCS code Code description 0SPB48Z ..... 0SPB48Z ..... Removal of spacer from left hip joint, percutaneous endoscopic approach. Removal of spacer from left hip joint, percutaneous endoscopic approach. and 0SRB01Z ..... and 0SRB029 ..... Removal of spacer from left hip joint, percutaneous endoscopic approach. and 0SRB02A .... Removal of spacer from left endoscopic approach. Removal of spacer from left endoscopic approach. Removal of spacer from left endoscopic approach. Removal of spacer from left endoscopic approach. Removal of spacer from left endoscopic approach. hip joint, percutaneous and 0SRB02Z ..... hip joint, percutaneous and 0SRB039 ..... hip joint, percutaneous and 0SRB03A .... hip joint, percutaneous and 0SRB03Z ..... hip joint, percutaneous and 0SRB049 ..... 0SPB48Z ..... Removal of spacer from left hip joint, percutaneous endoscopic approach. and 0SRB04A .... 0SPB48Z ..... Removal of spacer from left endoscopic approach. Removal of spacer from left endoscopic approach. Removal of spacer from left endoscopic approach. Removal of spacer from left endoscopic approach. Removal of spacer from left endoscopic approach. hip joint, percutaneous and 0SRB04Z ..... hip joint, percutaneous and 0SRB0J9 ..... hip joint, percutaneous and 0SRB0JA ..... hip joint, percutaneous and 0SRB0JZ ..... hip joint, percutaneous and 0SRE009 ..... 0SPB48Z ..... Removal of spacer from left hip joint, percutaneous endoscopic approach. and 0SRE00A .... 0SPB48Z ..... Removal of spacer from left hip joint, percutaneous endoscopic approach. and 0SRE00Z ..... 0SPB48Z ..... Removal of spacer from left hip joint, percutaneous endoscopic approach. and 0SRE019 ..... 0SPB48Z ..... Removal of spacer from left hip joint, percutaneous endoscopic approach. and 0SRE01A .... 0SPB48Z ..... and 0SRE01Z ..... 0SPB48Z ..... Removal of spacer from left hip joint, percutaneous endoscopic approach. Removal of spacer from left hip joint, percutaneous endoscopic approach. and 0SRE039 ..... 0SPB48Z ..... Removal of spacer from left hip joint, percutaneous endoscopic approach. and 0SRE03A .... 0SPB48Z ..... Removal of spacer from left hip joint, percutaneous endoscopic approach. and 0SRE03Z ..... 0SPB48Z ..... Removal of spacer from left hip joint, percutaneous endoscopic approach. and 0SRE0J9 ..... 0SPB48Z ..... Removal of spacer from left hip joint, percutaneous endoscopic approach. and 0SRE0JA ..... 0SPB48Z ..... Removal of spacer from left hip joint, percutaneous endoscopic approach. Removal of spacer from left hip joint, percutaneous endoscopic approach. and 0SRE0JZ ..... and 0SRS019 ..... Replacement of left hip joint with metal synthetic substitute, open approach. Replacement of left hip joint with metal on polyethylene synthetic substitute, cemented, open approach. Replacement of left hip joint with metal on polyethylene synthetic substitute, uncemented, open approach. Replacement of left hip joint with metal on polyethylene synthetic substitute, open approach. Replacement of left hip joint with ceramic synthetic substitute, cemented, open approach. Replacement of left hip joint with ceramic synthetic substitute, uncemented, open approach. Replacement of left hip joint with ceramic synthetic substitute, open approach. Replacement of left hip joint with ceramic on polyethylene synthetic substitute, cemented, open approach. Replacement of left hip joint with ceramic on polyethylene synthetic substitute, uncemented, open approach. Replacement of left hip joint with ceramic on polyethylene synthetic substitute, open approach. Replacement of left hip joint with synthetic substitute, cemented, open approach. Replacement of left hip joint with synthetic substitute, uncemented, open approach. Replacement of left hip joint with synthetic substitute, open approach. Replacement of left hip joint, acetabular surface with polyethylene synthetic substitute, cemented, open approach. Replacement of left hip joint, acetabular surface with polyethylene synthetic substitute, uncemented, open approach. Replacement of left hip joint, acetabular surface with polyethylene synthetic substitute, open approach. Replacement of left hip joint, acetabular surface with metal synthetic substitute, cemented, open approach. Replacement of left hip joint, acetabular surface with metal synthetic substitute, uncemented, open approach. Replacement of left hip joint, acetabular surface with metal synthetic substitute, open approach. Replacement of left hip joint, acetabular surface with ceramic synthetic substitute, cemented, open approach. Replacement of left hip joint, acetabular surface with ceramic synthetic substitute, uncemented, open approach. Replacement of left hip joint, acetabular surface with ceramic synthetic substitute, open approach. Replacement of left hip joint, acetabular surface with synthetic substitute, cemented, open approach. Replacement of left hip joint, acetabular surface with synthetic substitute, uncemented, open approach. Replacement of left hip joint, acetabular surface with synthetic substitute, open approach. Replacement of left hip joint, femoral surface with metal synthetic substitute, cemented, open approach. 0SPB48Z ..... 0SPB48Z ..... 0SPB48Z ..... 0SPB48Z ..... 0SPB48Z ..... 0SPB48Z ..... 0SPB48Z ..... 0SPB48Z ..... 0SPB48Z ..... tkelley on DSK3SPTVN1PROD with PROPOSALS2 0SPB48Z ..... 0SPB48Z ..... VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00069 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 24392 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND 468: PROPOSED NEW HIP REVISION ICD–10–PCS COMBINATIONS—Continued ICD–10–PCS code Code description ICD–10–PCS code Code description 0SPB48Z ..... Removal of spacer from left hip joint, percutaneous endoscopic approach. and 0SRS01A .... and 0SRS01Z ..... 0SPB48Z ..... Removal of spacer from left hip joint, percutaneous endoscopic approach. Removal of spacer from left hip joint, percutaneous endoscopic approach. and 0SRS039 ..... 0SPB48Z ..... Removal of spacer from left hip joint, percutaneous endoscopic approach. and 0SRS03A .... 0SPB48Z ..... Removal of spacer from left hip joint, percutaneous endoscopic approach. Removal of spacer from left hip joint, percutaneous endoscopic approach. Removal of spacer from left hip joint, percutaneous endoscopic approach. and 0SRS03Z ..... and 0SRS0J9 ..... and 0SRS0JA ..... Removal of spacer from left hip joint, percutaneous endoscopic approach. Removal of spacer from left hip joint, percutaneous endoscopic approach. Removal of spacer from left hip joint, percutaneous endoscopic approach. Removal of spacer from left hip joint, percutaneous endoscopic approach. Removal of synthetic substitute from left hip joint, percutaneous endoscopic approach. Removal of synthetic substitute from left hip joint, percutaneous endoscopic approach. Removal of synthetic substitute from left hip joint, percutaneous endoscopic approach. Removal of synthetic substitute from left hip joint, percutaneous endoscopic approach. and 0SRS0JZ ..... and 0SUB09Z ..... Replacement of left hip joint, femoral surface with metal synthetic substitute, uncemented, open approach. Replacement of left hip joint, femoral surface with metal synthetic substitute, open approach. Replacement of left hip joint, femoral surface with ceramic synthetic substitute, cemented, open approach. Replacement of left hip joint, femoral surface with ceramic synthetic substitute, uncemented, open approach. Replacement of left hip joint, femoral surface with ceramic synthetic substitute, open approach. Replacement of left hip joint, femoral surface with synthetic substitute, cemented, open approach. Replacement of left hip joint, femoral surface with synthetic substitute, uncemented, open approach. Replacement of left hip joint, femoral surface with synthetic substitute, open approach. Supplement left hip joint with liner, open approach. 0SPB48Z ..... and 0SUE09Z ..... and 0SUS09Z ..... and 0SRB019 ..... and 0SRB01A .... and 0SRB01Z ..... and 0SRB029 ..... 0SPB4JZ ...... Removal of synthetic substitute from left hip joint, percutaneous endoscopic approach. and 0SRB02A .... 0SPB4JZ ...... Removal of synthetic substitute from left percutaneous endoscopic approach. Removal of synthetic substitute from left percutaneous endoscopic approach. Removal of synthetic substitute from left percutaneous endoscopic approach. Removal of synthetic substitute from left percutaneous endoscopic approach. Removal of synthetic substitute from left percutaneous endoscopic approach. hip joint, and 0SRB02Z ..... hip joint, and 0SRB039 ..... hip joint, and 0SRB03A .... hip joint, and 0SRB03Z ..... hip joint, and 0SRB049 ..... 0SPB4JZ ...... Removal of synthetic substitute from left hip joint, percutaneous endoscopic approach. and 0SRB04A .... 0SPB4JZ ...... Removal of synthetic substitute from left percutaneous endoscopic approach. Removal of synthetic substitute from left percutaneous endoscopic approach. Removal of synthetic substitute from left percutaneous endoscopic approach. Removal of synthetic substitute from left percutaneous endoscopic approach. Removal of synthetic substitute from left percutaneous endoscopic approach. hip joint, and 0SRB04Z ..... hip joint, and 0SRB0J9 ..... hip joint, and 0SRB0JA ..... hip joint, and 0SRB0JZ ..... hip joint, and 0SRE009 ..... 0SPB4JZ ...... Removal of synthetic substitute from left hip joint, percutaneous endoscopic approach. and 0SRE00A .... 0SPB4JZ ...... Removal of synthetic substitute from left hip joint, percutaneous endoscopic approach. and 0SRE00Z ..... 0SPB48Z ..... 0SPB48Z ..... 0SPB48Z ..... 0SPB48Z ..... 0SPB48Z ..... 0SPB48Z ..... 0SPB4JZ ...... 0SPB4JZ ...... 0SPB4JZ ...... 0SPB4JZ ...... 0SPB4JZ ...... 0SPB4JZ ...... 0SPB4JZ ...... 0SPB4JZ ...... 0SPB4JZ ...... 0SPB4JZ ...... tkelley on DSK3SPTVN1PROD with PROPOSALS2 0SPB4JZ ...... 0SPB4JZ ...... VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00070 Fmt 4701 Sfmt 4702 Supplement left hip joint, acetabular surface with liner, open approach. Supplement left hip joint, femoral surface with liner, open approach. Replacement of left hip joint with metal synthetic substitute, cemented, open approach. Replacement of left hip joint with metal synthetic substitute, uncemented, open approach. Replacement of left hip joint with metal synthetic substitute, open approach. Replacement of left hip joint with metal on polyethylene synthetic substitute, cemented, open approach. Replacement of left hip joint with metal on polyethylene synthetic substitute, uncemented, open approach. Replacement of left hip joint with metal on polyethylene synthetic substitute, open approach. Replacement of left hip joint with ceramic synthetic substitute, cemented, open approach. Replacement of left hip joint with ceramic synthetic substitute, uncemented, open approach. Replacement of left hip joint with ceramic synthetic substitute, open approach. Replacement of left hip joint with ceramic on polyethylene synthetic substitute, cemented, open approach. Replacement of left hip joint with ceramic on polyethylene synthetic substitute, uncemented, open approach. Replacement of left hip joint with ceramic on polyethylene synthetic substitute, open approach. Replacement of left hip joint with synthetic substitute, cemented, open approach. Replacement of left hip joint with synthetic substitute, uncemented, open approach. Replacement of left hip joint with synthetic substitute, open approach. Replacement of left hip joint, acetabular surface with polyethylene synthetic substitute, cemented, open approach. Replacement of left hip joint, acetabular surface with polyethylene synthetic substitute, uncemented, open approach. Replacement of left hip joint, acetabular surface with polyethylene synthetic substitute, open approach. E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 24393 MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND 468: PROPOSED NEW HIP REVISION ICD–10–PCS COMBINATIONS—Continued ICD–10–PCS code Code description ICD–10–PCS code Code description 0SPB4JZ ...... Removal of synthetic substitute from left hip joint, percutaneous endoscopic approach. and 0SRE019 ..... Removal of synthetic substitute from left hip joint, percutaneous endoscopic approach. and 0SRE01A .... and 0SRE01Z ..... 0SPB4JZ ...... Removal of synthetic substitute from left hip joint, percutaneous endoscopic approach. Removal of synthetic substitute from left hip joint, percutaneous endoscopic approach. and 0SRE039 ..... 0SPB4JZ ...... Removal of synthetic substitute from left hip joint, percutaneous endoscopic approach. and 0SRE03A .... 0SPB4JZ ...... Removal of synthetic substitute from left hip joint, percutaneous endoscopic approach. and 0SRE03Z ..... 0SPB4JZ ...... Removal of synthetic substitute from left hip joint, percutaneous endoscopic approach. and 0SRE0J9 ..... 0SPB4JZ ...... Removal of synthetic substitute from left hip joint, percutaneous endoscopic approach. and 0SRE0JA ..... 0SPB4JZ ...... and 0SRE0JZ ..... 0SPB4JZ ...... Removal of synthetic substitute from left hip joint, percutaneous endoscopic approach. Removal of synthetic substitute from left hip joint, percutaneous endoscopic approach. and 0SRS019 ..... 0SPB4JZ ...... Removal of synthetic substitute from left hip joint, percutaneous endoscopic approach. and 0SRS01A .... 0SPB4JZ ...... and 0SRS01Z ..... 0SPB4JZ ...... Removal of synthetic substitute from left hip joint, percutaneous endoscopic approach. Removal of synthetic substitute from left hip joint, percutaneous endoscopic approach. and 0SRS039 ..... 0SPB4JZ ...... Removal of synthetic substitute from left hip joint, percutaneous endoscopic approach. and 0SRS03A .... 0SPB4JZ ...... Removal of synthetic substitute from left hip joint, percutaneous endoscopic approach. Removal of synthetic substitute from left hip joint, percutaneous endoscopic approach. Removal of synthetic substitute from left hip joint, percutaneous endoscopic approach. and 0SRS03Z ..... and 0SRS0J9 ..... and 0SRS0JA ..... Removal of synthetic substitute from left percutaneous endoscopic approach. Removal of synthetic substitute from left percutaneous endoscopic approach. Removal of synthetic substitute from left percutaneous endoscopic approach. Removal of synthetic substitute from left percutaneous endoscopic approach. hip joint, and 0SRS0JZ ..... hip joint, and 0SUB09Z ..... Replacement of left hip joint, acetabular surface with metal synthetic substitute, cemented, open approach. Replacement of left hip joint, acetabular surface with metal synthetic substitute, uncemented, open approach. Replacement of left hip joint, acetabular surface with metal synthetic substitute, open approach. Replacement of left hip joint, acetabular surface with ceramic synthetic substitute, cemented, open approach. Replacement of left hip joint, acetabular surface with ceramic synthetic substitute, uncemented, open approach. Replacement of left hip joint, acetabular surface with ceramic synthetic substitute, open approach. Replacement of left hip joint, acetabular surface with synthetic substitute, cemented, open approach. Replacement of left hip joint, acetabular surface with synthetic substitute, uncemented, open approach. Replacement of left hip joint, acetabular surface with synthetic substitute, open approach. Replacement of left hip joint, femoral surface with metal synthetic substitute, cemented, open approach. Replacement of left hip joint, femoral surface with metal synthetic substitute, uncemented, open approach. Replacement of left hip joint, femoral surface with metal synthetic substitute, open approach. Replacement of left hip joint, femoral surface with ceramic synthetic substitute, cemented, open approach. Replacement of left hip joint, femoral surface with ceramic synthetic substitute, uncemented, open approach. Replacement of left hip joint, femoral surface with ceramic synthetic substitute, open approach. Replacement of left hip joint, femoral surface with synthetic substitute, cemented, open approach. Replacement of left hip joint, femoral surface with synthetic substitute, uncemented, open approach. Replacement of left hip joint, femoral surface with synthetic substitute, open approach. Supplement left hip joint with liner, open approach. 0SPB4JZ ...... 0SPB4JZ ...... hip joint, and 0SUE09Z ..... hip joint, and 0SUS09Z ..... 0SPB4JZ ...... 0SPB4JZ ...... 0SPB4JZ ...... 0SPB4JZ ...... 0SPB4JZ ...... 0SPB4JZ ...... Supplement left hip joint, acetabular surface with liner, open approach. Supplement left hip joint, femoral surface with liner, open approach tkelley on DSK3SPTVN1PROD with PROPOSALS2 MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND 468: PROPOSED NEW KNEE REVISION ICD–10–PCS COMBINATIONS ICD–10–PCS code 0SPC09Z 0SPC09Z 0SPC09Z VerDate Sep<11>2014 ICD–10–PCS code Code description and 0SRC0J9 ..... and 0SRC0JA .... and 0SRC0JZ ..... Replacement of right knee joint with synthetic substitute, cemented, open approach. Replacement of right knee joint with synthetic substitute, uncemented, open approach. Replacement of right knee joint with synthetic substitute, open approach. Code descriptions Removal of liner from right knee joint, open approach. Removal of liner from right knee joint, open approach. Removal of liner from right knee joint, open approach. 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00071 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 24394 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND 468: PROPOSED NEW KNEE REVISION ICD–10–PCS COMBINATIONS—Continued ICD–10–PCS code ICD–10–PCS code Code descriptions Code description Replacement of right knee joint, femoral surface with synthetic substitute, cemented, open approach. Replacement of right knee joint, femoral surface with synthetic substitute, uncemented, open approach. Replacement of right knee joint, femoral surface with synthetic substitute, open approach. Replacement of right knee joint, tibial surface with synthetic substitute, cemented, open approach. Replacement of right knee joint, tibial surface with synthetic substitute, uncemented, open approach. Replacement of right knee joint, tibial surface with synthetic substitute, open approach. Replacement of right knee joint, femoral surface with synthetic substitute, cemented, open approach. Replacement of right knee joint, femoral surface with synthetic substitute, uncemented, open approach. Replacement of right knee joint, tibial surface with synthetic substitute, cemented, open approach. Replacement of right knee joint, tibial surface with synthetic substitute, uncemented, open approach. Replacement of right knee joint, femoral surface with synthetic substitute, cemented, open approach. Replacement of right knee joint, femoral surface with synthetic substitute, uncemented, open approach. Replacement of right knee joint, tibial surface with synthetic substitute, cemented, open approach. Replacement of right knee joint, tibial surface with synthetic substitute, uncemented, open approach. Replacement of left knee joint with synthetic substitute, cemented, open approach. Replacement of left knee joint with synthetic substitute, uncemented, open approach. Replacement of left knee joint with synthetic substitute, open approach. Replacement of left knee joint, femoral surface with synthetic substitute, cemented, open approach. Replacement of left knee joint, femoral surface with synthetic substitute, uncemented, open approach. Replacement of left knee joint, femoral surface with synthetic substitute, open approach. Replacement of left knee joint, tibial surface with synthetic substitute, cemented, open approach. Replacement of left knee joint, tibial surface with synthetic substitute, uncemented, open approach. Replacement of left knee joint, tibial surface with synthetic substitute, open approach. Replacement of left knee joint, femoral surface with synthetic substitute, cemented, open approach. Replacement of left knee joint, femoral surface with synthetic substitute, uncemented, open approach. Replacement of left knee joint, tibial surface with synthetic substitute, cemented, open approach. Replacement of left knee joint, tibial surface with synthetic substitute, uncemented, open approach. 0SPC09Z Removal of liner from right knee joint, open approach. and 0SRT0J9 ..... 0SPC09Z Removal of liner from right knee joint, open approach. and 0SRT0JA ..... 0SPC09Z Removal of liner from right knee joint, open approach. Removal of liner from right knee joint, open approach. Removal of liner from right knee joint, open approach. and 0SRT0JZ ..... and 0SRV0J9 ..... and 0SRV0JA ..... and 0SRV0JZ ..... 0SPC0JZ Removal of liner from right knee joint, open approach. Removal of synthetic substitute from right knee joint, open approach. and 0SRT0J9 ..... 0SPC0JZ Removal of synthetic substitute from right knee joint, open approach. and 0SRT0JA ..... 0SPC0JZ synthetic substitute from right knee approach. synthetic substitute from right knee approach. and 0SRV0J9 ..... 0SPC0JZ Removal of joint, open Removal of joint, open and 0SRV0JA ..... 0SPC4JZ Removal of synthetic substitute from right knee joint, percutaneous endoscopic approach. and 0SRT0J9 ..... 0SPC4JZ Removal of synthetic substitute from right knee joint, percutaneous endoscopic approach. and 0SRT0JA ..... 0SPC4JZ Removal of synthetic substitute joint, percutaneous endoscopic Removal of synthetic substitute joint, percutaneous endoscopic from right knee approach. from right knee approach. and 0SRV0J9 ..... and 0SRV0JA ..... liner from left knee joint, open ap- and 0SRD0J9 ..... liner from left knee joint, open ap- and 0SRD0JA .... liner from left knee joint, open ap- and 0SRD0JZ ..... liner from left knee joint, open ap- and 0SRU0J9 ..... 0SPD09Z Removal of liner from left knee joint, open approach. and 0SRU0JA .... 0SPD09Z Removal of liner from left knee joint, open approach. Removal of liner from left knee joint, open approach. Removal of liner from left knee joint, open approach. and 0SRU0JZ ..... and 0SRW0J9 .... and 0SRW0JA .... and 0SRW0JZ .... 0SPD0JZ Removal of liner from left knee joint, open approach. Removal of synthetic substitute from left knee joint, open approach. and 0SRU0J9 ..... 0SPD0JZ Removal of synthetic substitute from left knee joint, open approach. and 0SRU0JA .... 0SPD0JZ Removal of joint, open Removal of joint, open and 0SRW0J9 .... and 0SRW0JA .... 0SPC09Z 0SPC09Z 0SPC09Z 0SPC4JZ 0SPD09Z 0SPD09Z 0SPD09Z 0SPD09Z 0SPD09Z 0SPD09Z tkelley on DSK3SPTVN1PROD with PROPOSALS2 0SPD09Z 0SPD0JZ VerDate Sep<11>2014 Removal of proach. Removal of proach. Removal of proach. Removal of proach. synthetic substitute from left knee approach. synthetic substitute from left knee approach. 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00072 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 24395 MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND 468: PROPOSED NEW KNEE REVISION ICD–10–PCS COMBINATIONS—Continued ICD–10–PCS code 0SPD0JZ ICD–10–PCS code Code descriptions Code description Replacement of left knee joint, tibial surface with synthetic substitute, open approach. Replacement of left knee joint, femoral surface with synthetic substitute, cemented, open approach. Replacement of left knee joint, femoral surface with synthetic substitute, uncemented, open approach. Replacement of left knee joint, tibial surface with synthetic substitute, cemented, open approach. Replacement of left knee joint, tibial surface with synthetic substitute, uncemented, open approach. Replacement of left knee joint, tibial surface with synthetic substitute, open approach. and 0SRW0JZ .... 0SPD4JZ Removal of synthetic substitute from left knee joint, open approach. Removal of synthetic substitute from left knee joint, percutaneous endoscopic approach. and 0SRU0J9 ..... 0SPD4JZ Removal of synthetic substitute from left knee joint, percutaneous endoscopic approach. and 0SRU0JA .... 0SPD4JZ and 0SRW0J9 .... 0SPD4JZ Removal of synthetic substitute from left knee joint, percutaneous endoscopic approach. Removal of synthetic substitute from left knee joint, percutaneous endoscopic approach. and 0SRW0JA .... 0SPD4JZ Removal of synthetic substitute from left knee joint, percutaneous endoscopic approach. and 0SRW0JZ .... We are inviting public comments on our proposal to add the joint revision code combinations listed above to MS– DRGs 466, 467, and 468. tkelley on DSK3SPTVN1PROD with PROPOSALS2 b. 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, we are proposing new titles for these three MS–DRGs that would change the reference of ‘‘9+ Fusions’’ to ‘‘Extensive Fusions.’’ The proposed 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) • MS–DRG 458 (Spinal Fusion Except Cervical with Spinal Curvature/ Malignancy/Infection or Extensive Fusion without CC/MCC). We are inviting public comments on our proposal. VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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 code 3E0P7GC (Introduction of other therapeutic substance into female reproductive, via natural or artificial opening) describes this procedure. We reviewed how this 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.) code affecting MS–DRG assignment. We agree with the requestor that the current logic for ICD–10–PCS procedure code 3E0P7GC does not result in the appropriate MS–DRG assignment. The result of our analysis suggests that this code should not be designated as an O.R. code. Our clinical advisors agree that this procedure does not require the intensity or complexity of service and resource utilization to merit an O.R. designation under ICD–10. Therefore, we are proposing 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 are inviting public comments on our proposal. Our analysis of ICD–10–PCS 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 PO 00000 Frm 00073 Fmt 4701 Sfmt 4702 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 antiinflammatory 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 affecting 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 our clinical advisors’ recommendation, we are proposing to designate the above listed ICD–10–PCS procedure codes as non-O.R. codes to ensure that these codes will group to the appropriate MS–DRG assignment. We are inviting public comments on our proposal. E:\FR\FM\30APP2.SGM 30APP2 24396 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 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 these MS–DRGs, we examined claims data from the December 2014 update of the FY 2014 MedPAR file for 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 T63.001A ...................... T63.011A ...................... T63.021A ...................... T63.031A ...................... T63.041A ...................... T63.061A ...................... T63.71A ........................ T63.081A ...................... T63.091A ...................... Code description Toxic Toxic Toxic Toxic Toxic Toxic Toxic Toxic Toxic effect effect effect effect effect effect effect effect effect of of of of of of of of of unspecified snake venom, accidental (unintentional), initial encounter. rattlesnake venom, accidental (unintentional) initial encounter. coral snake venom, accidental (unintentional), initial encounter. taipan venom, accidental (unintentional), initial encounter. cobra venom, accidental (unintentional), initial encounter. venom of other North and South American snake, accidental (unintentional), initial encounter. venom of other Australian snake, accidental (unintentional), initial encounter. venom of other African and Asian snake, accidental (unintentional), initial encounter. 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 T63.001A ...................... T63.011A ...................... T63.021A ...................... T63.031A ...................... T63.041A ...................... T63.061A ...................... T63.71A ........................ T63.081A ...................... T63.091A ...................... Code description Toxic Toxic Toxic Toxic Toxic Toxic Toxic Toxic Toxic effect effect effect effect effect effect effect effect effect of of of of of of of of of unspecified snake venom, accidental (unintentional), initial encounter. rattlesnake venom, accidental (unintentional) initial encounter. coral snake venom, accidental (unintentional), initial encounter. taipan venom, accidental (unintentional), initial encounter. cobra venom, accidental (unintentional), initial encounter. venom of other North and South American snake, accidental (unintentional), initial encounter. venom of other Australian snake, accidental (unintentional), initial encounter. venom of other African and Asian snake, accidental (unintentional), initial encounter. venom of other snake, accidental (unintentional), initial encounter. We examined claims data for injections for snake bites reported 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 cases MS–DRG tkelley on DSK3SPTVN1PROD with PROPOSALS2 MS–DRG 917—All cases ............................................................................................................ MS–DRG 917—Cases with principal diagnosis code 989.5 and secondary diagnosis code E905.0 with procedure code 99.16 (non-OR) .......................................................................... MS–DRG 918—All cases ............................................................................................................ MS–DRG 918—Cases with principal diagnosis code 989.5 and secondary diagnosis code E905.0 with procedure code 99.16 (non-OR) .......................................................................... As shown in the table above, we identified 19 cases of injections for snake bites reported in MS–DRG 918 only. 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 find another MS–DRG that would be a more appropriate MS–DRG assignment for these cases based on the VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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 PO 00000 Frm 00074 Fmt 4701 Sfmt 4702 Average length of stay Average costs 26,393 4.77 $9,983 0 24,557 0 2.90 0 4,953 19 2.16 12,014 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 CroFab antivenom drug for snake bites because these cases are clinically similar to other poisoning cases currently assigned to E:\FR\FM\30APP2.SGM 30APP2 24397 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules MS–DRGs 917 and 918. Based on the findings in our data analysis and the recommendations of our clinical advisors, we are proposing to maintain the current assignment of diagnosis codes in MS–DRGs 917 and 918. We are not proposing any MS–DRG changes for cases of CroFab antivenom drugs for snake bites. We are inviting public comments on our proposal. 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 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: https:// www.cms.gov/Medicare/Coding/ICD10/ ICD-10-MS-DRG-ConversionProject.html. As stated earlier, 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 Proposed MS–DRG Changes), which is available via the Internet on the CMS Web site at: https://www.cms.gov/ Medicare/Medicare-Fee-for-ServicePayment/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 MedPAR file. The following table shows our findings. EXTENSIVE BURNS OR FULL THICKNESS BURNS WITH MECHANICAL VENTILATION 96+ HOURS WITH SKIN GRAFT Number of cases MS–DRG tkelley on DSK3SPTVN1PROD with PROPOSALS2 MS–DRG 927—All cases ............................................................................................................ MS–DRG 927—Cases with procedure code 86.67 .................................................................... MS–DRG 927—Cases with procedure code 86.67 and 96.72 (Mechanical ventilation for 96+ hours) ....................................................................................................................................... MS–DRG 927—Cases with procedure code 86.67 and without 96.72 (Mechanical ventilation for 96+ hours) ........................................................................................................................... MS–DRG 927—All cases with MCC ........................................................................................... MS–DRG 927—All cases with CC .............................................................................................. MS–DRG 927—All cases without CC/MCC ................................................................................ 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. The requested new severity level does 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 this 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 does not meet the criterion that there are at least 500 cases in the CC or MCC subgroup. We also point 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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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 does not meet the criterion for the creation of an additional severity level, and the recommendations of our clinical advisors, we are not proposing to create a new severity level for MS–DRG 927. We are proposing to maintain the current MS–DRG 927 structure without additional severity levels. We are inviting public comments on our proposal. PO 00000 Frm 00075 Fmt 4701 Sfmt 4702 Average length of stay Average costs 171 22 29.92 33.5 $113,844 146,903 14 38.6 174,372 8 131 38 2 24.6 31.51 25.21 15.00 98,482 121,519 91,910 27,872 8. Proposed 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 this proposed 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: https://www.cms.gov/ E:\FR\FM\30APP2.SGM 30APP2 24398 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules Medicare/Coding/ICD10/ICD-10-MSDRG-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: https://www.cms.gov/ Medicare/Coding/ICD10/ICD-10-MSDRG-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 are proposing to add the ICD–10–PCS 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. 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 .......................... E08.00 .......................... Myelofibrosis. Diabetes mellitus due to underlying condition with hyperosmolarity without nonketotic hyperglycemic-hyperosmolar coma (NKHHC). Diabetes mellitus due to underlying condition with hyperosmolarity with coma. Diabetes mellitus due to underlying condition with ketoacidosis without coma. Diabetes mellitus due to underlying condition with ketoacidosis with coma. Diabetes mellitus due to underlying condition with diabetic nephropathy. Diabetes mellitus due to underlying condition with diabetic chronic kidney disease. Diabetes mellitus due to underlying condition with other diabetic kidney complication. Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema. Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy without macular edema. Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema. Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy without macular edema. Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema. Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy without macular edema. Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema. Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy without macular edema. Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema. Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy without macular edema. Diabetes mellitus due to underlying condition with diabetic cataract. Diabetes mellitus due to underlying condition with other diabetic ophthalmic complication. Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified. Diabetes mellitus due to underlying condition with diabetic mononeuropathy. Diabetes mellitus due to underlying condition with diabetic polyneuropathy. Diabetes mellitus due to underlying condition with diabetic autonomic (poly)neuropathy. Diabetes mellitus due to underlying condition with diabetic amyotrophy. Diabetes mellitus due to underlying condition with other diabetic neurological complication. Diabetes mellitus due to underlying condition with diabetic peripheral angiopathy without gangrene. Diabetes mellitus due to underlying condition with diabetic peripheral angiopathy with gangrene. Diabetes mellitus due to underlying condition with other circulatory complications. Diabetes mellitus due to underlying condition with diabetic neuropathic arthropathy. Diabetes mellitus due to underlying condition with other diabetic arthropathy. Diabetes mellitus due to underlying condition with diabetic dermatitis. Diabetes mellitus due to underlying condition with foot ulcer. Diabetes mellitus due to underlying condition with other skin ulcer. Diabetes mellitus due to underlying condition with other skin complications. Diabetes mellitus due to underlying condition with periodontal disease. Diabetes mellitus due to underlying condition with other oral complications. Diabetes mellitus due to underlying condition with hypoglycemia with coma. Diabetes mellitus due to underlying condition with hypoglycemia without coma. Diabetes mellitus due to underlying condition with hyperglycemia. Diabetes mellitus due to underlying condition with other specified complication. Diabetes mellitus due to underlying condition with unspecified complications. Diabetes mellitus due to underlying condition without complications. E08.01 .......................... E08.10 .......................... E08.11 .......................... E08.21 .......................... E08.22 .......................... E08.29 .......................... E08.311 ........................ E08.319 ........................ E08.321 ........................ E08.329 ........................ E08.331 ........................ E08.339 ........................ tkelley on DSK3SPTVN1PROD with PROPOSALS2 E08.341 ........................ E08.349 ........................ E08.351 ........................ E08.359 ........................ E08.36 .......................... E08.39 .......................... E08.40 .......................... E08.41 .......................... E08.42 .......................... E08.43 .......................... E08.44 .......................... E08.49 .......................... E08.51 .......................... E08.52 .......................... E08.59 .......................... E08.610 ........................ E08.618 ........................ E08.620 ........................ E08.621 ........................ E08.622 ........................ E08.628 ........................ E08.630 ........................ E08.638 ........................ E08.641 ........................ E08.649 ........................ E08.65 .......................... E08.69 .......................... E08.8 ............................ E08.9 ............................ We are inviting 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. VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 We also are proposing 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), PO 00000 Frm 00076 Fmt 4701 Sfmt 4702 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 E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules tkelley on DSK3SPTVN1PROD with PROPOSALS2 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 hours, we are proposing 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 are inviting public comments on our proposal. 9. Proposed 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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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 lowerweighted 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 higherordered surgical class has lower average costs than the class ordered below it. Based on the changes that we are proposing to make for FY 2016, as discussed in section II.G.3.e. of the preamble of this FY 2016 IPPS/LTCH PPS proposed rule, we are proposing to revise the surgical hierarchy for MDC 5 (Diseases and Disorders of the Circulatory System). Specifically, we are proposing to delete MS–DRG 237 (Major Cardiovascular Procedures with MCC) and MS–DRG 238 (Major Cardiovascular Procedures without MCC) from the PO 00000 Frm 00077 Fmt 4701 Sfmt 4702 24399 surgical hierarchy. We are proposing 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 are proposing 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 are proposing 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 are inviting public comments on our proposals. 10. Proposed Changes to the MS–DRG Diagnosis Codes for FY 2016 a. 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: https://www.cms.gov/Medicare/ Medicare-Fee-for-Service-Payment/ AcuteInpatientPPS/ as follows: • Table 6I (Complete MCC list); • Table 6J (Complete CC list); and • Table 6K (Complete list of CC Exclusions). b. 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, E:\FR\FM\30APP2.SGM 30APP2 24400 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules respectively), and the FY 2015 IPPS/ LTCH PPS proposed rule and final rule SDX 414.4 .................. tkelley on DSK3SPTVN1PROD with PROPOSALS2 CC level SDX description 414.2 .................. Chronic total occlusion of coronary artery. Coronary atherosclerosis due to calcified coronary lesion. 18:20 Apr 29, 2015 Jkt 235001 Cnt 1 Cnt 1 impact MedPAR file for ICD–9–CM diagnosis codes 414.2 and 414.4. The following table shows our findings. Cnt 2 Cnt 2 impact Cnt 3 Cnt 3 impact Non-CC 14,655 1.393 21,222 2.098 20,615 3.046 Non-CC 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. VerDate Sep<11>2014 (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 1,752 1.412 3,238 2.148 3,244 3.053 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 do 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, we are not proposing to reclassify conditions represented by diagnosis codes 414.2 and 414.4 to MCCs. We are proposing 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 are proposing to maintain ICD–10–CM diagnosis codes I25.82 and I25.84 as non-CCs. We are inviting public comments on our proposals. c. 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 PO 00000 Frm 00078 Fmt 4701 Sfmt 4702 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: https://www.cms.gov/Medicare/ Coding/ICD10/ICD-10-MS-DRGConversion-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 N13.2) 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). We agree 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 are proposing 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 32. We are inviting public comments on our proposal. 11. Proposed Complications or Comorbidity (CC) Exclusions List for FY 2016 a. 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 E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules tkelley on DSK3SPTVN1PROD with PROPOSALS2 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). b. Proposed 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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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.4 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: https://www.cms.gov/Medicare/Coding/ ICD10/ICD-10-MS-DRG-ConversionProject.html. For FY 2016, we are not proposing any changes to the CC Exclusion List. Because we are not proposing 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 4 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. PO 00000 Frm 00079 Fmt 4701 Sfmt 4702 24401 (Deletions from the CC Exclusion List). We have developed Table 6K (Complete List of CC Exclusions), which is available only via the Internet on the CMS Web site at: https://www.cms.gov/ Medicare/Medicare-Fee-for-ServicePayment/AcuteInpatientPPS/ index.html. Because of the length of Table 6K, we are not publishing it in the Addendum to this proposed 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: https://www.cms.gov/Medicare/ Medicare-Fee-for-Service-Payment/ AcuteInpatientPPS/. Because there are no proposed 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 proposed rule and they are not published as part of this proposed 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 proposed revised or deleted procedure codes for FY 2016, we have not developed Table 6D (Invalid Procedure Codes) or Table 6F (Revised Procedure Codes). We are not proposing 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. Therefore, for this proposed 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 proposed rule. We have developed Table 6M.1 (Additions to Principal Diagnosis Is Its Own CC) to show the two proposed 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 E:\FR\FM\30APP2.SGM 30APP2 24402 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules Exclusions List, is available via the Internet on the CMS Web site at: https:// www.cms.gov/Medicare/Coding/ICD10/ ICD-10-MS-DRG-ConversionProject.html. The complete documentation of the ICD–10 MS–DRG GROUPER logic will be available on the CMS Acute Inpatient PPS Web page after the issuance of the final rule at: https://www.cms.gov/Medicare/ Medicare-Fee-for-Service-Payment/ AcuteInpatientPPS/. tkelley on DSK3SPTVN1PROD with PROPOSALS2 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); VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 • 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.5 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 are not proposing to change the procedures assigned among these MS–DRGs. 5 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). PO 00000 Frm 00080 Fmt 4701 Sfmt 4702 We are inviting public comments on our proposal. a. 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 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 are not proposing 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 are inviting public comments on our proposal. b. 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 E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 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 are not proposing to move any procedure codes among these MS–DRGs. (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– 24403 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 tkelley on DSK3SPTVN1PROD with PROPOSALS2 ICD–10–PCS code 03LG0BZ ...................... 03LG0DZ ...................... 03LG3BZ ...................... 03LG3DZ ...................... 03LG4BZ ...................... 03LG4DZ ...................... 03LH0BZ ....................... 03LH0DZ ...................... 03LH3BZ ....................... 03LH3DZ ...................... 03LH4BZ ....................... 03LH4DZ ...................... 03LJ0BZ ....................... 03LJ0DZ ....................... 03LJ3BZ ....................... 03LJ3DZ ....................... 03LJ4BZ ....................... 03LJ4DZ ....................... 03LK0BZ ....................... 03LK0DZ ....................... 03LK3BZ ....................... 03LK3DZ ....................... 03LK4BZ ....................... 03LK4DZ ....................... 03LL0BZ ....................... 03LL0DZ ....................... 03LL3BZ ....................... 03LL3DZ ....................... 03LL4BZ ....................... 03LL4DZ ....................... 03LM0BZ ...................... 03LM0DZ ...................... 03LM3BZ ...................... 03LM3DZ ...................... 03LM4BZ ...................... 03LM4DZ ...................... 03LN0BZ ....................... 03LN0DZ ...................... 03LN3BZ ....................... 03LN3DZ ...................... 03LN4BZ ....................... 03LN4DZ ...................... 03LP0BZ ....................... 03LP0DZ ....................... VerDate Sep<11>2014 Code description Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion Occlusion 18:20 Apr 29, 2015 of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of of intracranial artery with bioactive intraluminal device, open approach. intracranial artery with intraluminal device, open approach. intracranial artery with bioactive intraluminal device, percutaneous approach. intracranial artery with intraluminal device, percutaneous approach. intracranial artery with bioactive intraluminal device, percutaneous endoscopic approach. intracranial artery with intraluminal device, percutaneous endoscopic approach. right common carotid artery with bioactive intraluminal device, open approach. right common carotid artery with intraluminal device, open approach. right common carotid artery with bioactive intraluminal device, percutaneous approach. right common carotid artery with intraluminal device, percutaneous approach. right common carotid artery with bioactive intraluminal device, percutaneous endoscopic approach. right common carotid artery with intraluminal device, percutaneous endoscopic approach. left common carotid artery with bioactive intraluminal device, open approach. left common carotid artery with intraluminal device, open approach. left common carotid artery with bioactive intraluminal device, percutaneous approach. left common carotid artery with intraluminal device, percutaneous approach. left common carotid artery with bioactive intraluminal device, percutaneous endoscopic approach. left common carotid artery with intraluminal device, percutaneous endoscopic approach. right internal carotid artery with bioactive intraluminal device, open approach. right internal carotid artery with intraluminal device, open approach. right internal carotid artery with bioactive intraluminal device, percutaneous approach. right internal carotid artery with intraluminal device, percutaneous approach. right internal carotid artery with bioactive intraluminal device, percutaneous endoscopic approach. right internal carotid artery with intraluminal device, percutaneous endoscopic approach. left internal carotid artery with bioactive intraluminal device, open approach. left internal carotid artery with intraluminal device, open approach. left internal carotid artery with bioactive intraluminal device, percutaneous approach. left internal carotid artery with intraluminal device, percutaneous approach. left internal carotid artery with bioactive intraluminal device, percutaneous endoscopic approach. left internal carotid artery with intraluminal device, percutaneous endoscopic approach. right external carotid artery with bioactive intraluminal device, open approach. right external carotid artery with intraluminal device, open approach. right external carotid artery with bioactive intraluminal device, percutaneous approach. right external carotid artery with intraluminal device, percutaneous approach. right external carotid artery with bioactive intraluminal device, percutaneous endoscopic approach. right external carotid artery with intraluminal device, percutaneous endoscopic approach. left external carotid artery with bioactive intraluminal device, open approach. left external carotid artery with intraluminal device, open approach. left external carotid artery with bioactive intraluminal device, percutaneous approach. left external carotid artery with intraluminal device, percutaneous approach. left external carotid artery with bioactive intraluminal device, percutaneous endoscopic approach. left external carotid artery with intraluminal device, percutaneous endoscopic approach. right vertebral artery with bioactive intraluminal device, open approach. right vertebral artery with intraluminal device, open approach. Jkt 235001 PO 00000 Frm 00081 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 24404 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules ICD–10–PCS CODES FOR ENDOVASCULAR EMBOLIZATION OR OCCLUSION OF VESSEL(S) OF HEAD OR NECK USING BARE COILS AND BIOACTIVE COILS—Continued tkelley on DSK3SPTVN1PROD with PROPOSALS2 ICD–10–PCS code 03LP3BZ ....................... 03LP3DZ ....................... 03LP4BZ ....................... 03LP4DZ ....................... 03LQ0BZ ...................... 03LQ0DZ ...................... 03LQ3BZ ...................... 03LQ3DZ ...................... 03LQ4BZ ...................... 03LQ4DZ ...................... 03VG0BZ ...................... 03VG0DZ ...................... 03VG3BZ ...................... 03VG3DZ ...................... 03VG4BZ ...................... 03VG4DZ ...................... 03VH0BZ ...................... 03VH0DZ ...................... 03VH3BZ ...................... 03VH3DZ ...................... 03VH4BZ ...................... 03VH4DZ ...................... 03VJ0BZ ....................... 03VJ0DZ ....................... 03VJ3BZ ....................... 03VJ3DZ ....................... 03VJ4BZ ....................... 03VJ4DZ ....................... 03VK0BZ ...................... 03VK0DZ ...................... 03VK3BZ ...................... 03VK3DZ ...................... 03VK4BZ ...................... 03VK4DZ ...................... 03VL0BZ ....................... 03VL0DZ ....................... 03VL3BZ ....................... 03VL3DZ ....................... 03VL4BZ ....................... 03VL4DZ ....................... 03VM0BZ ...................... 03VM0DZ ...................... 03VM3BZ ...................... 03VM3DZ ...................... 03VM4BZ ...................... 03VM4DZ ...................... 03VN0BZ ...................... 03VN0DZ ...................... 03VN3BZ ...................... 03VN3DZ ...................... 03VN4BZ ...................... 03VN4DZ ...................... 03VP0BZ ...................... 03VP0DZ ...................... 03VP3BZ ...................... 03VP3DZ ...................... 03VP4BZ ...................... 03VP4DZ ...................... 03VQ0BZ ...................... 03VQ0DZ ...................... 03VQ3BZ ...................... 03VQ3DZ ...................... 03VQ4BZ ...................... 03VQ4DZ ...................... 03VR0DZ ...................... 03VR3DZ ...................... 03VR4DZ ...................... 03VS0DZ ...................... 03VS3DZ ...................... 03VS4DZ ...................... 03VT0DZ ...................... VerDate Sep<11>2014 Code description Occlusion of right vertebral artery with bioactive intraluminal device, percutaneous approach. Occlusion of right vertebral artery with intraluminal device, percutaneous approach. Occlusion of right vertebral artery with bioactive intraluminal device, percutaneous endoscopic approach. Occlusion of right vertebral artery with intraluminal device, percutaneous endoscopic approach. Occlusion of left vertebral artery with bioactive intraluminal device, open approach. Occlusion of left vertebral artery with intraluminal device, open approach. Occlusion of left vertebral artery with bioactive intraluminal device, percutaneous approach. Occlusion of left vertebral artery with intraluminal device, percutaneous approach. Occlusion of left vertebral artery with bioactive intraluminal device, percutaneous endoscopic approach. Occlusion of left vertebral artery with intraluminal device, percutaneous endoscopic approach. Restriction of intracranial artery with bioactive intraluminal device, open approach. Restriction of intracranial artery with intraluminal device, open approach. Restriction of intracranial artery with bioactive intraluminal device, percutaneous approach. Restriction of intracranial artery with intraluminal device, percutaneous approach. Restriction of intracranial artery with bioactive intraluminal device, percutaneous endoscopic approach. Restriction of intracranial artery with intraluminal device, percutaneous endoscopic approach. Restriction of right common carotid artery with bioactive intraluminal device, open approach. Restriction of right common carotid artery with intraluminal device, open approach. Restriction of right common carotid artery with bioactive intraluminal device, percutaneous approach. Restriction of right common carotid artery with intraluminal device, percutaneous approach. Restriction of right common carotid artery with bioactive intraluminal device, percutaneous endoscopic approach. Restriction of right common carotid artery with intraluminal device, percutaneous endoscopic approach. Restriction of left common carotid artery with bioactive intraluminal device, open approach. Restriction of left common carotid artery with intraluminal device, open approach. Restriction of left common carotid artery with bioactive intraluminal device, percutaneous approach. Restriction of left common carotid artery with intraluminal device, percutaneous approach. Restriction of left common carotid artery with bioactive intraluminal device, percutaneous endoscopic approach. Restriction of left common carotid artery with intraluminal device, percutaneous endoscopic approach. Restriction of right internal carotid artery with bioactive intraluminal device, open approach. Restriction of right internal carotid artery with intraluminal device, open approach. Restriction of right internal carotid artery with bioactive intraluminal device, percutaneous approach. Restriction of right internal carotid artery with intraluminal device, percutaneous approach. Restriction of right internal carotid artery with bioactive intraluminal device, percutaneous endoscopic approach. Restriction of right internal carotid artery with intraluminal device, percutaneous endoscopic approach. Restriction of left internal carotid artery with bioactive intraluminal device, open approach. Restriction of left internal carotid artery with intraluminal device, open approach. Restriction of left internal carotid artery with bioactive intraluminal device, percutaneous approach. Restriction of left internal carotid artery with intraluminal device, percutaneous approach. Restriction of left internal carotid artery with bioactive intraluminal device, percutaneous endoscopic approach. Restriction of left internal carotid artery with intraluminal device, percutaneous endoscopic approach. Restriction of right external carotid artery with bioactive intraluminal device, open approach. Restriction of right external carotid artery with intraluminal device, open approach. Restriction of right external carotid artery with bioactive intraluminal device, percutaneous approach. Restriction of right external carotid artery with intraluminal device, percutaneous approach. Restriction of right external carotid artery with bioactive intraluminal device, percutaneous endoscopic approach. Restriction of right external carotid artery with intraluminal device, percutaneous endoscopic approach. Restriction of left external carotid artery with bioactive intraluminal device, open approach. Restriction of left external carotid artery with intraluminal device, open approach. Restriction of left external carotid artery with bioactive intraluminal device, percutaneous approach. Restriction of left external carotid artery with intraluminal device, percutaneous approach. Restriction of left external carotid artery with bioactive intraluminal device, percutaneous endoscopic approach. Restriction of left external carotid artery with intraluminal device, percutaneous endoscopic approach. Restriction of right vertebral artery with bioactive intraluminal device, open approach. Restriction of right vertebral artery with intraluminal device, open approach. Restriction of right vertebral artery with bioactive intraluminal device, percutaneous approach. Restriction of right vertebral artery with intraluminal device, percutaneous approach. Restriction of right vertebral artery with bioactive intraluminal device, percutaneous endoscopic approach. Restriction of right vertebral artery with intraluminal device, percutaneous endoscopic approach. Restriction of left vertebral artery with bioactive intraluminal device, open approach. Restriction of left vertebral artery with intraluminal device, open approach. Restriction of left vertebral artery with bioactive intraluminal device, percutaneous approach. Restriction of left vertebral artery with intraluminal device, percutaneous approach. Restriction of left vertebral artery with bioactive intraluminal device, percutaneous endoscopic approach. Restriction of left vertebral artery with intraluminal device, percutaneous endoscopic approach. Restriction of face artery with intraluminal device, open approach. Restriction of face artery with intraluminal device, percutaneous approach. Restriction of face artery with intraluminal device, percutaneous endoscopic approach. Restriction of right temporal artery with intraluminal device, open approach. Restriction of right temporal artery with intraluminal device, percutaneous approach. Restriction of right temporal artery with intraluminal device, percutaneous endoscopic approach. Restriction of left temporal artery with intraluminal device, open approach. 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00082 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 24405 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules ICD–10–PCS CODES FOR ENDOVASCULAR EMBOLIZATION OR OCCLUSION OF VESSEL(S) OF HEAD OR NECK USING BARE COILS AND BIOACTIVE COILS—Continued ICD–10–PCS code 03VT3DZ 03VT4DZ 03VU0DZ 03VU3DZ 03VU4DZ 03VV0DZ 03VV3DZ 03VV4DZ ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... Code description Restriction Restriction Restriction Restriction Restriction Restriction Restriction Restriction of of of of of of of of left temporal artery with intraluminal device, percutaneous approach. left temporal artery with intraluminal device, percutaneous endoscopic approach. right thyroid artery with intraluminal device, open approach. right thyroid artery with intraluminal device, percutaneous approach. right thyroid artery with intraluminal device, percutaneous endoscopic approach. left thyroid artery with intraluminal device, open approach. left thyroid artery with intraluminal device, percutaneous approach. 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 tkelley on DSK3SPTVN1PROD with PROPOSALS2 MS–DRG 981—All cases ............................................................................................................ MS–DRG 981—Epistaxis cases with principal diagnosis code 784.7 and procedure code 39.75 ........................................................................................................................................ MS–DRG 981—Epistaxis cases with principal diagnosis code 784.7 and procedure code 39.76 ........................................................................................................................................ MS–DRG 982—All cases ............................................................................................................ MS–DRG 982—Epistaxis cases with principal diagnosis code 784.7 and procedure code 39.75 ........................................................................................................................................ MS–DRG 982—Epistaxis cases with principal diagnosis code 784.7 and procedure code 39.76 ........................................................................................................................................ MS–DRG 983—All cases ............................................................................................................ MS–DRG 983—Epistaxis cases with principal diagnosis code 784.7 and procedure code 39.75 ........................................................................................................................................ MS–DRG 983—Epistaxis cases with 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 room procedures that are unrelated to the principal diagnosis. Because there VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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, we are not proposing to create new MS–DRG assignments for epistaxis cases receiving endovascular embolization procedures. We are proposing to maintain the current MS– DRG structure for epistaxis cases receiving endovascular embolization procedures and are not proposing any updates to MS–DRGs 981, 982, and 983. We are inviting public comments on our proposal. PO 00000 Average length of stay Number of cases MS–DRG Frm 00083 Fmt 4701 Sfmt 4702 Average costs 21,118 12.38 $33,080 8 6.50 34,655 2 13,657 12.50 7.14 50,081 19,392 22 3.14 17,725 2 2,989 2.0 3.60 11,010 12,760 5 2.60 10,532 4 1.50 16,658 c. 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 proposed rule, we are not proposing to add any diagnosis or procedure codes to MDCs for FY 2016. We are inviting public comments on our proposal. 13. Proposed Changes to the ICD–9–CM System a. 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 E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 24406 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 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 nonFederal 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: https://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: https:// 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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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: https://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: https:// www.cdc.gov/nchs/icd/icd9cmmaintenance.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, CoChairperson, 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, CoChairperson, 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 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. PO 00000 Frm 00084 Fmt 4701 Sfmt 4702 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 E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 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: https://www.cms.gov/ Medicare/Coding/ ICD9ProviderDiagnosticCodes/ index.html?redirect=/ icd9ProviderDiagnosticCodes/ 01overview.asp#TopofPage. ICD–10–CM and ICD–10–PCS addendum and code VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 title information is published on the CMS Web site at https://www.cms.gov/ Medicare/Coding/ICD10/. 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: https:// www.cdc.gov/nchs/. 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. b. 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 Committee and public comment was actively solicited. The Committee evaluated all comments from participants attending the Committee meetings as well as written comments PO 00000 Frm 00085 Fmt 4701 Sfmt 4702 24407 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: https:// www.cms.gov/Medicare/Coding/ICD10/ ICD-9-CM-Coordination-andMaintenance-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: https:// 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. E:\FR\FM\30APP2.SGM 30APP2 24408 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules • 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: https://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: https://www.cms.gov/ Medicare/Coding/ ICD9ProviderDiagnosticCodes/ICD-9CM-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 Fiscal Year Number tkelley on DSK3SPTVN1PROD with PROPOSALS2 FY 2009 (October 1, 2008): Diagnoses .......................................... Procedures ........................................ FY 2010 (October 1, 2009): Diagnoses .......................................... Procedures ........................................ FY 2011(October 1, 2010): Diagnoses .......................................... Procedures ........................................ FY 2012 (October 1, 2011): Diagnoses .......................................... Procedures ........................................ FY 2013 (October 1, 2012): Diagnoses .......................................... Procedures ........................................ FY 2014 (October 1, 2013): Diagnoses .......................................... Procedures ........................................ FY 2015 (October 1, 2014): Diagnoses .......................................... Procedures ........................................ FY 2016 (October 1, 2015): Diagnoses .......................................... Procedures ........................................ 18:20 Apr 29, 2015 Jkt 235001 Change Fiscal Year 14,025 3,824 348 56 14,315 3,838 290 14 14,432 3,859 135 18 14,567 3,878 0 1 14,567 3,882 0 4 14,567 3,882 0 0 14,567 3,882 0 0 FY FY FY FY FY ICD–10–CM ...................................... ICD–10–PCS .................................... 2012: ICD–10–CM ...................................... ICD–10–PCS .................................... 2013: ICD–10–CM ...................................... ICD–10–PCS .................................... 2014: ICD–10–CM ...................................... ICD–10–PCS .................................... 2015: ICD–10–CM ...................................... ICD–10–PCS .................................... 2016: ICD–10–CM ...................................... ICD–10–PCS .................................... 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 PO 00000 Frm 00086 Fmt 4701 Number FY 2009: ICD–10–CM ...................................... ICD–10–PCS .................................... FY 2010: ICD–10–CM ...................................... ICD–10–PCS .................................... 117 21 14,567 3,877 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– VerDate Sep<11>2014 ICD–10–CM and ICD–10–PCS Codes Sfmt 4702 Change 68,069 72,589 +5 ¥14,327 69,099 71,957 +1,030 ¥632 69,368 72,081 +269 +124 69,833 71,918 +465 ¥163 69,832 71,920 ¥1 +2 69,823 71,924 ¥9 +4 69,823 71,924 0 0 69,823 71,962 0 +38 18–19, 2015 Committee meeting was April 17, 2015. 14. Other Proposed Policy Changes: Replaced Devices Offered Without Cost or With a Credit a. 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 E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 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. b. 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 ‘‘devicedependent’’ 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 ‘‘devicedependent’’ 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, we are proposing 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 this proposed rule, for FY 2016, we are proposing 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 24409 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, if finalized, 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. In summary, we are proposing to add 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 if the applicable proposed MS–DRG changes are finalized, to also remove existing MS–DRGs 237 and 238 and add proposed new MS–DRGs 268 through 272. The 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 is displayed below. PROPOSED LIST OF MS–DRGS SUBJECT TO THE IPPS POLICY FOR REPLACED DEVICES OFFERED WITHOUT COST OR WITH A CREDIT tkelley on DSK3SPTVN1PROD with PROPOSALS2 MDC MS– DRG PreMDC ....... PreMDC ....... MDC 01 ........ MDC 01 ........ MDC 01 ........ MDC 01 ........ MDC 01 ........ MDC 01 ........ MDC 01 ........ MDC 01 ........ MDC 03 ........ MDC 03 ........ MDC 05 ........ MDC 05 ........ MDC 05 ........ MDC 05 ........ MDC 05 ........ MDC 05 ........ MDC 05 ........ MDC 05 ........ MDC 05 ........ MDC 05 ........ MDC 05 ........ MDC 05 ........ MDC 05 ........ MDC 05 ........ MDC 05 ........ MDC 05 ........ MDC 05 ........ MDC 05 ........ 001 002 023 024 025 026 027 040 041 042 129 130 215 216 217 218 219 220 221 222 223 224 225 226 227 242 243 244 245 258 VerDate Sep<11>2014 MS–DRG Title Heart Transplant or Implant of Heart Assist System with MCC. Heart Transplant or Implant of Heart Assist System without MCC. Craniotomy with Major Device Implant/Acute Complex CNS PDX with MCC or Chemo Implant. Craniotomy with Major Device Implant/Acute Complex CNS PDX without MCC. Craniotomy & Endovascular Intracranial Procedures with MCC. Craniotomy & Endovascular Intracranial Procedures with CC. Craniotomy & Endovascular Intracranial Procedures without CC/MCC. Peripheral/Cranial Nerve & Other Nervous System Procedures with MCC. Peripheral/Cranial Nerve & Other Nervous System Procedures with CC or Peripheral Neurostimulation. Peripheral/Cranial Nerve & Other Nervous System Procedures without CC/MCC. Major Head & Neck Procedures with CC/MCC or Major Device. Major Head & Neck Procedures without CC/MCC. Other Heart Assist System Implant. Cardiac Valve & Other Major Cardiothoracic Procedures with Cardiac Catheterization with MCC. Cardiac Valve & Other Major Cardiothoracic Procedures with Cardiac Catheterization with CC. Cardiac Valve & Other Major Cardiothoracic Procedures with Cardiac Catheterization without CC/MCC. Cardiac Valve & Other Major Cardiothoracic Procedures without Cardiac Catheterization with MCC. Cardiac Valve & Other Major Cardiothoracic Procedures without Cardiac Catheterization with CC. Cardiac Valve & Other Major Cardiothoracic Procedures without Cardiac Catheterization without CC/MCC. Cardiac Defibrillator Implant with Cardiac Catheterization with AMI/HF/Shock with MCC. Cardiac Defibrillator Implant with Cardiac Catheterization with AMI/HF/Shock without MCC. Cardiac Defibrillator Implant with Cardiac Catheterization without AMI/HF/Shock with MCC. Cardiac Defibrillator Implant with Cardiac Catheterization without AMI/HF/Shock without MCC. Cardiac Defibrillator Implant without Cardiac Catheterization with MCC. Cardiac Defibrillator Implant without Cardiac Catheterization without MCC. Permanent Cardiac Pacemaker Implant with MCC. Permanent Cardiac Pacemaker Implant with CC. Permanent Cardiac Pacemaker Implant without CC/MCC. AICD Generator Procedures. Cardiac Pacemaker Device Replacement with MCC. 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00087 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 24410 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules PROPOSED LIST OF MS–DRGS SUBJECT TO THE IPPS POLICY FOR REPLACED DEVICES OFFERED WITHOUT COST OR WITH A CREDIT—Continued MDC MDC MDC MDC MDC MDC MDC MDC MDC MDC MDC MDC MDC MDC MDC MDC MDC MDC MDC MDC 05 05 05 05 05 05 05 05 05 05 05 05 08 08 08 08 08 08 08 ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ MS– DRG 259 260 261 262 265 266 267 268 269 270 271 272 461 462 466 467 468 469 470 MS–DRG Title Cardiac Pacemaker Device Replacement without MCC. Cardiac Pacemaker Revision Except Device Replacement with MCC. Cardiac Pacemaker Revision Except Device Replacement with CC. Cardiac Pacemaker Revision Except Device Replacement without CC/MCC. AICD Lead Procedures. Endovascular Cardiac Valve Replacement with MCC. Endovascular Cardiac Valve Replacement without MCC. Aortic and Heart Assist Procedures Except Pulsation Balloon with MCC. Aortic and Heart Assist Procedures Except Pulsation Balloon without MCC. Other Major Cardiovascular Procedures with MCC. Other Major Cardiovascular Procedures with CC. Other Major Cardiovascular Procedures without CC/MCC. Bilateral or Multiple Major Joint Procedures of Lower Extremity with MCC. Bilateral or Multiple Major Joint Procedures of Lower Extremity without MCC. Revision of Hip or Knee Replacement with MCC. Revision of Hip or Knee Replacement with CC. Revision of Hip or Knee Replacement without CC/MCC. Major Joint Replacement or Reattachment of Lower Extremity with MCC. Major Joint Replacement or Reattachment of Lower Extremity without MCC. We are inviting 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. The final list will be included in the FY 2016 IPPS/LTCH PPS final rule and also will be issued to providers in the form of a Change Request (CR). tkelley on DSK3SPTVN1PROD with PROPOSALS2 H. Recalibration of the Proposed FY 2016 MS–DRG Relative Weights 1. Data Sources for Developing the Relative Weights In developing the proposed 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 proposed rule include discharges occurring on October 1, 2013, through September 30, 2014, based on bills received by CMS through December 31, 2014, 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 proposed relative weights includes data for approximately 9,638,230 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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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 December 31, 2014 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 proposed 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 proposed 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 costbased 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 December 31, 2014 update of the FY 2013 HCRIS for calculating the proposed FY 2016 costbased relative weights. PO 00000 Frm 00088 Fmt 4701 Sfmt 4702 2. Methodology for Calculation of the Proposed Relative Weights As we explain in section II.E.3. of the preamble of this proposed 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 proposed 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 proposed FY 2016 MS–DRG classifications discussed in sections II.B. and II.G. of the preamble of this proposed 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 Medicareapproved 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 E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 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. (We refer readers to the FY 2015 IPPS/ LTCH PPS final rule (79 FR 49911) for the edit threshold related to FY 2015.) • 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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 (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. 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 PO 00000 Frm 00089 Fmt 4701 Sfmt 4702 24411 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, we are proposing to continue 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: https:// innovation.cms.gov/initiatives/BundledPayments/ 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-ofliving 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 proposed 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. E:\FR\FM\30APP2.SGM 30APP2 24412 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules Cost center group name (19 total) MedPAR charge field Revenue codes contained in MedPAR charge field Cost from HCRIS (Worksheet C, Part 1, Column 5 and line number) Form CMS–2552–10 Charges from HCRIS (Worksheet C, Part 1, Column 6 & 7 and line number) Form CMS–2552–10 Medicare charges from HCRIS (Worksheet D–3, Column & line number) Form CMS–2552–10 Adults & Pediatrics (General Routine Care). ................................ C_1_C5_30 ....... C_1_C6_30 ....... D3_HOS_C2_30 ........................... ........................... Cost report line description Routine Days ......... Private Room Charges. 011X and 014X ...... Intensive Days ....... Semi–Private Room Charges. Ward Charges ........ Intensive Care Charges. Coronary Care Charges. 012X, 013X and 016X–019X. 015X ...................... 020X ...................... ................................ Intensive Care Unit ........................... C_1_C5_31 ....... ........................... C_1_C6_31 ....... D3_HOS_C2_31 021X ...................... Coronary Care Unit C_1_C5_32 ....... C_1_C6_32 ....... D3_HOS_C2_32 C_1_C5_33 ....... C_1_C6_33 ....... D3_HOS_C2_33 C_1_C5_34 ....... C_1_C6_34 ....... D3_HOS_C2_34 C_1_C5_35 ....... C_1_C6_35 ....... D3_HOS_C2_35 025X, 026X and 063X. Burn Intensive Care Unit. Surgical Intensive Care Unit. Other Special Care Unit. Intravenous Therapy. Drugs Charged To Patient. Medical Supplies Charged to Patients. C_1_C5_64 ....... C_1_C6_64 ....... C_1_C7_64 C_1_C6_73 ....... C_1_C7_73 C_1_C6_71 ....... C_1_C7_71 D3_HOS_C2_64 C_1_C5_96 ....... C_1_C6_96 ....... C_1_C7_96 D3_HOS_C2_96 C_1_C6_97 ....... C_1_C7_97 C_1_C6_72 ....... C_1_C7_72 D3_HOS_C2_97 C_1_C6_66 C_1_C7_66 C_1_C6_67 C_1_C7_67 C_1_C6_68 C_1_C7_68 C_1_C6_65 C_1_C7_65 C_1_C6_50 C_1_C7_50 C_1_C6_51 C_1_C7_51 C_1_C6_52 C_1_C7_52 C_1_C6_53 C_1_C7_53 C_1_C6_69 C_1_C7_69 C_1_C6_59 C_1_C7_59 C_1_C6_60 C_1_C7_60 C_1_C6_61 C_1_C7_61 C_1_C6_70 C_1_C7_70 C_1_C6_54 C_1_C7_54 C_1_C6_55 ....... D3_HOS_C2_66 ....... D3_HOS_C2_67 ....... D3_HOS_C2_68 ....... D3_HOS_C2_65 ....... D3_HOS_C2_50 ....... D3_HOS_C2_51 ....... D3_HOS_C2_52 ....... D3_HOS_C2_53 ....... D3_HOS_C2_69 ....... D3_HOS_C2_59 ....... D3_HOS_C2_60 ....... D3_HOS_C2_61 ....... D3_HOS_C2_70 ....... D3_HOS_C2_54 ....... D3_HOS_C2_55 C_1_C6_56 ....... C_1_C7_56 C_1_C6_57 ....... C_1_C7_57 D3_HOS_C2_56 Drugs ..................... Supplies and Equipment. Pharmacy Charges Medical/Surgical Supply Charges. Durable Medical Equipment Charges. Used Durable Medical Charges. Inhalation Therapy C_1_C5_71 ....... Physical Therapy Charges. Occupational Therapy Charges. Speech Pathology Charges. Inhalation Therapy Charges. Operating Room Charges. 0293 ....................... DME–Sold .............. C_1_C5_97 ....... 0275, 0276, 0278, 0624. Implantable Devices Therapy Services ... 0270, 0271, 0272, 0273, 0274, 0277, 0279, and 0621, 0622, 0623. 0290, 0291, 0292 DME–Rented ......... and 0294–0299. C_1_C5_73 ....... Implantable Devices Charged to Patients. Physical Therapy ... C_1_C5_72 ....... 042X ...................... 043X ...................... 044X and 047X ...... C_1_C5_67 ....... C_1_C5_68 ....... 036X ...................... Respiratory Therapy. Operating Room .... C_1_C5_50 ....... 071X ...................... Recovery Room ..... C_1_C5_51 ....... 072X ...................... 037X ...................... Delivery Room and Labor Room. Anesthesiology ...... C_1_C5_52 ....... Anesthesia ............. Operating Room Charges. Anesthesia Charges C_1_C5_53 ....... Cardiology .............. Cardiology Charges 048X and 073X ...... Electro-cardiology .. C_1_C5_69 ....... 0481 ....................... Cardiac Catheterization. Laboratory .............. C_1_C5_59 ....... Operating Room .... Labor & Delivery .... Cardiac Catheterization. Laboratory .............. Laboratory Charges 041X and 046X ...... Occupational Therapy. Speech Pathology C_1_C5_66 ....... 030X, 031X, and 075X. tkelley on DSK3SPTVN1PROD with PROPOSALS2 074X, 086X ............ Radiology ............... Radiology Charges 032X, 040X ............ 028X, 0331, 0332, 0333, 0335, 0339, 0342. 0343 and 344 ........ Computed Tomography (CT) Scan. VerDate Sep<11>2014 CT Scan Charges .. 19:26 Apr 29, 2015 Jkt 235001 035X ...................... PO 00000 Frm 00090 PBP Clinic Laboratory Services. Electro-Encephalography. Radiology—Diagnostic. Radiology—Therapeutic. C_1_C5_65 ....... C_1_C5_60 ....... C_1_C5_61 ....... C_1_C5_70 ....... C_1_C5_54 ....... C_1_C5_55 ....... Radioisotope .......... C_1_C5_56 ....... Computed Tomography (CT) Scan. C_1_C5_57 ....... Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 D3_HOS_C2_73 D3_HOS_C2_71 D3_HOS_C2_72 D3_HOS_C2_57 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules Cost center group name (19 total) MedPAR charge field Revenue codes contained in MedPAR charge field Magnetic Resonance Imaging (MRI). Emergency Room .. MRI Charges .......... 061X ...................... Emergency Room Charges. Blood Charges ....... 045X ...................... Cost report line description Magnetic Resonance Imaging (MRI). Emergency ............. 24413 Cost from HCRIS (Worksheet C, Part 1, Column 5 and line number) Form CMS–2552–10 Charges from HCRIS (Worksheet C, Part 1, Column 6 & 7 and line number) Form CMS–2552–10 Medicare charges from HCRIS (Worksheet D–3, Column & line number) Form CMS–2552–10 C_1_C5_58 ....... C_1_C6_58 ....... C_1_C7_58 D3_HOS_C2_58 C_1_C5_91 ....... D3_HOS_C2_91 Other Services ....... 039X ...................... D3_HOS_C2_63 Other Service Charge. 0002–0099, 022X, 023X, 024X,052X,053X. 055X–060X, 064X– 070X, 076X– 078X, 090X– 095X and 099X. 0800X .................... 080X and 082X– 088X. Renal Dialysis ........ ESRD Revenue Setting Charges. Outpatient Service Charges. Lithotripsy Charge .. Clinic Visit Charges Professional Fees Charges. Ambulance Charges. 049X ...................... 079X ...................... 051X ...................... 096X, 097X, and 098X. 054X ...................... 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. tkelley on DSK3SPTVN1PROD with PROPOSALS2 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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 C_1_C5_63 ....... C_1_C6_63 ....... C_1_C7_63 ........................... ........................... ................................ ........................... ........................... Renal Dialysis ........ ................................ C_1_C5_74 ....... ........................... C_1_C6_74 ....... C_1_C7_74 D3_HOS_C2_74 Home Program Dialysis. ASC (Non Distinct Part). ................................ Other Ancillary ....... C_1_C5_94 ....... C_1_C6_94 ....... C_1_C7_94 C_1_C6_75 ....... D3_HOS_C2_94 ........................... C_1_C5_76 ....... Clinic ...................... C_1_C5_90 ....... C_1_C5_92.01 .. Other Outpatient Services. Ambulance ............. C_1_C5_93 ....... C_1_C5_95 ....... C_1_C5_88 ....... FQHC ..................... Blood Storage/Processing. C_1_C5_62 ....... Rural Health Clinic 038X ...................... Whole Blood & Packed Red Blood Cells. Blood Storing, Processing, & Transfusing. ................................ Observation beds ... Blood and Blood Products. C_1_C6_91 ....... C_1_C7_91 C_1_C6_62 ....... C_1_C7_62 C_1_C5_89 ....... C_1_C5_75 ....... 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 Medicarespecific 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 PO 00000 Frm 00091 Fmt 4701 Sfmt 4702 C_1_C7_75 C_1_C6_76 ....... C_1_C7_76 C_1_C6_90 ....... C_1_C7_90 C_1_C6_92.01 .. C_1_C7_92.01 C_1_C6_93 ....... C_1_C7_93 C_1_C6_95 ....... C_1_C7_95 C_1_C6_88 ....... C_1_C7_88 C_1_C6_89 ....... C_1_C7_89 D3_HOS_C2_62 D3_HOS_C2_75 D3_HOS_C2_76 D3_HOS_C2_90 D3_HOS_C2_ 92.01 D3_HOS_C2_93 D3_HOS_C2_95 D3_HOS_C2_88 D3_HOS_C2_89 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 E:\FR\FM\30APP2.SGM 30APP2 24414 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules per case to determine the relative weight. The proposed FY 2016 cost-based relative weights were then normalized by an adjustment factor of 1.678672 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 proposed 19 national average CCRs for FY 2016 are as follows: Group Routine Days .................................... Intensive Days .................................. Drugs ................................................ Supplies & Equipment ...................... Implantable Devices ......................... Therapy Services .............................. Laboratory ......................................... Operating Room ............................... Cardiology ......................................... Cardiac Catheterization .................... Radiology .......................................... MRIs ................................................. CT Scans .......................................... Emergency Room ............................. Blood and Blood Products ................ Other Services .................................. Labor & Delivery ............................... Group Inhalation Therapy ............................ Anesthesia ........................................ 0.178 0.108 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. For FY 2016, we are proposing to use that same case threshold in recalibrating the MS–DRG CCR relative weights for FY 2016. Using data from the FY 2014 MedPAR file, there 0.485 were 8 MS–DRGs that contain fewer 0.399 than 10 cases. Under the MS–DRGs, we 0.192 0.299 have fewer low-volume DRGs than 0.344 under the CMS DRGs because we no 0.335 longer have separate DRGs for patients 0.125 aged 0 to 17 years. With the exception 0.201 of newborns, we previously separated 0.119 some DRGs based on whether the 0.125 patient was age 0 to 17 years or age 17 0.159 years and older. Other than the age split, 0.085 cases grouping to these DRGs are 0.041 0.184 identical. The DRGs for patients aged 0 0.340 to 17 years generally have very low 0.367 volumes because children are typically 0.404 ineligible for Medicare. In the past, we Low-volume MS–DRG MS–DRG Title 768 ............... 791 ............... Vaginal Delivery with O.R. Procedure Except Sterilization and/or D&C. Neonates, Died or Transferred to Another Acute Care Facility. Extreme Immaturity or Respiratory Distress Syndrome, Neonate. Prematurity with Major Problems .............. 792 ............... Prematurity without Major Problems ......... 793 ............... Full-Term Neonate with Major Problems .. 794 ............... Neonate with Other Significant Problems 795 ............... Normal Newborn ....................................... 789 ............... 790 ............... We are inviting public comments on this proposal. 4. Solicitation of Public Comments on Expanding the Bundled Payments for Care Improvement (BPCI) Initiative tkelley on DSK3SPTVN1PROD with PROPOSALS2 CCR a. 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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 have found that the low volume of cases for the pediatric 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 these low-volume MS–DRGs, we are proposing to compute 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: Crosswalk to MS–DRG Final FY 2015 relative weight cases in other MS-DRGs). Final FY 2015 relative weight cases in other MS-DRGs). Final FY 2015 relative weight cases in other MS-DRGs). Final FY 2015 relative weight cases in other MS-DRGs). Final FY 2015 relative weight cases in other MS-DRGs). Final FY 2015 relative weight cases in other MS-DRGs). Final FY 2015 relative weight cases in other MS DRGs). Final FY 2015 relative weight cases in other MS-DRGs). (adjusted by percent change in average weight of the (adjusted by percent change in average weight of the (adjusted by percent change in average weight of the (adjusted by percent change in average weight of the (adjusted by percent change in average weight of the (adjusted by percent change in average weight of the (adjusted by percent change in average weight of the (adjusted by percent change in average weight of the 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 PO 00000 Frm 00092 Fmt 4701 Sfmt 4702 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: https:// innovation.cms.gov/initiatives/bundledpayments/. We also have included discussions of the BPCI initiative in the annual IPPS/LTCH PPS rulemakings since FY 2013 (77 FR 53341 through 53343). All four models in the BPCI initiative pay a discounted bundled payment for E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules a single episode of care as an alternative approach to payment for service delivery under traditional Medicare feefor-service (FFS). Model 1 participants are paid a discounted bundled payment in lieu of the standard IPPS payment upon submission of claims. In Models 2 and 3, the bundled payment is paid retrospectively through a reconciliation process; participants continue to submit claims and receive payment via the usual Medicare FFS payment systems. In Model 4, the bundled payment is made prospectively to a hospital, and participating physician and nonphysician practitioners submit ‘‘nopay’’ claims to CMS. In all models, participants in the BPCI initiative are permitted to share gains arising from the providers’ care redesign efforts under certain circumstances in which such arrangements would not otherwise be permitted under Medicare. Each of the four models in the BPCI initiative tests bundled payments for a different episode of care: • Model 1 tests retrospective bundled payments for the acute care hospital stay only. All participants in this model are acute care hospitals, and the episode of care is defined as the inpatient stay in the acute care hospital. The hospital is paid a discounted amount based on the payment rates established under the IPPS used in the original Medicare program. Physicians are paid separately for their services under the Medicare Physician Fee Schedule (MPFS). While Model 1 makes payments as described above for all MS–DRGs, Models 2, 3, and 4 of the BPCI initiative test 48 episodes (comprised of groupings of related MS–DRGs). These episodes and the groupings of related MS–DRGs that are included in these episodes are listed in the table below. • In Model 2, the episode of care includes the inpatient stay in an acute care hospital and all related services during the episode, including postacute care services. The episode ends either 30, 60, or 90 days after a hospital discharge. • Model 3 focuses on postacute care services. In this model, the episode of care is triggered by an acute care hospital stay for an MS–DRG included in the episode and begins at the initiation of postacute care services in a skilled nursing facility (SNF), inpatient rehabilitation facility (IRF), long-term care hospital (LTCH), or home health agency (HHA). The episode includes postacute care services, physicians’ services, and related services provided during an inpatient hospital readmission, but does not include services provided during the episodeinitiating acute care hospital stay. The VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 postacute care services included in the episode must begin within 30 days of discharge from the inpatient hospital stay and may end either 30, 60, or 90 days after the initiation of the episode. • Model 4 tests prospective single bundled payments for physicians’ services and hospital services furnished during an acute care hospitalization and related readmissions. Under this model, a single, prospectively determined bundled payment is made to the participating hospital that encompasses all services furnished during the inpatient stay by the hospital, physicians, and other practitioners. Payments for services furnished in related readmissions for 30 days after the hospital discharge are included in the bundled payment amount. Model 1 of the BPCI initiative began in April 2013. CMS has allowed for participation in two phases in Models 2, 3, and 4. The first phase is the preparatory phase. In the preparatory phase, participants in the BPCI initiative are provided claims data so that they may analyze patterns of care for episodes in preparation for improving care coordination and quality under bundled payments prior to participation in the second phase, the risk-bearing phase. In the BPCI initiative, the term ‘‘riskbearing’’ refers to the requirement that certain participants in the BPCI initiative bear financial risk for spending above the target price set by Medicare across the episodes of care in which they participate. By using this term, we do not connote any relationship to insurance; we narrowly define this term and use it only to highlight the following financial responsibilities: In the risk-bearing phase, awardees and awardee conveners in Models 2 and 3 are financially responsible to Medicare if FFS expenditures are higher than a target price established by Medicare for the episode(s) in which they are participating. Awardees assume risk on behalf of themselves; awardee conveners assume risk on behalf of others and, in some cases, themselves (as described below). Medicare will recoup the difference between the target price and the actual FFS expenditures from awardees and awardee conveners for all services included in the episode of care if the target price is exceeded. Medicare will pay awardees and awardee conveners the difference if actual FFS expenditures are below the target price. Awardees and awardee conveners in Model 4 who have assumed risk on behalf of themselves and/or others bear risk in that they assume financial responsibility if the PO 00000 Frm 00093 Fmt 4701 Sfmt 4702 24415 bundled prospective payment from Medicare does not cover the services included in the episode of care. Awardees and all participants under awardee conveners in Models 2, 3, and 4 must move to the risk-bearing phase by July 1, 2015. There are several entity types currently participating in the two phases included in the BPCI initiative’s Models 2, 3, and 4. Episode initiators, defined as the entities that initiate episodes of care in Models 2, 3, and 4, are provided claims data in the preparatory phase so that they may establish a structure for bundled payments prior to participation in the risk-bearing phase of the initiative. The entities that initiate episodes of care vary by model: In Model 4, episode initiators are acute care hospitals only; in Model 2, episode initiators are acute care hospitals and physician group practices; and in Model 3, episode initiators are SNFs, HHAs, LTCHs, IRFs, and physician group practices. To move into the risk-bearing phase, participants must be selected by CMS following a comprehensive review and enter into an agreement with CMS. In the risk-bearing phase, episode initiators participate through one of two options. The first option is that the episode initiator may be an awardee and sign an agreement directly with CMS containing a risk-bearing financial arrangement. While not required, risk-bearing episode initiators may be associated with a ‘‘facilitator convener,’’ an entity that convenes multiple health care providers and supports the episode initiators in implementing the BPCI initiative but does not itself bear any risk. Alternatively, through the second option, the episode initiator may participate in the BPCI initiative under an awardee convener, which is an organization that may or may not be a Medicare provider that assumes financial risk on behalf of the episode initiator. In the second option, the awardee convener signs an agreement with CMS containing the terms of participation in the model, including a risk-bearing financial arrangement. Participation through an awardee convener allows episode initiators to mitigate their financial risk, and participation through an awardee or facilitator convener allows episode initiators to benefit in many cases from the convener’s resources, such as enhanced technology and administrative assistance. As of April 2015, the participation in the risk-bearing phase of the BPCI initiative is as follows: Model 2 is testing 2,053 episodes among 345 episode initiators located in 45 States; E:\FR\FM\30APP2.SGM 30APP2 24416 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules Model 3 is testing 3,407 episodes among 318 episode initiators located in 29 States. Model 4 is testing 16 episodes among 9 episode initiators located in 7 States. There are 49 facilitator conveners and awardee conveners across the four models. In addition to the entities in the risk-bearing phase, several thousand entities in the preparatory phase are still considering whether to enter the performance phase, upon successful completion of screening and review by CMS. The episodes of care and the associated MS–DRGs that define the episodes that are being tested in Models 2, 3, and 4 of the BPCI initiative are listed in the table below. This table is based on FY 2015 IPPS MS–DRGs and does not account yet for proposed FY 2016 changes to the MS–DRGs. EPISODES OF CARE AND MS–DRG GROUPINGS UNDER THE BUNDLED PAYMENTS FOR CARE IMPROVEMENT INITIATIVE FOR MODELS 2, 3, AND 4 Episode of care MS–DRGs Acute myocardial infarction ............................................................................................................. AICD generator or lead ................................................................................................................... Amputation ....................................................................................................................................... 280, 281, 282. 245, 265. 239, 240, 241, 255, 256, 257, 474, 475, 476, 616, 617, 618. 302, 303. 518, 519, 520. 231, 232, 233, 234, 235, 236. 308, 309, 310. 222, 223, 224, 225, 226, 227. 216, 217, 218, 219, 220, 221, 266, 267. 602, 603. 471, 472, 473. 313. 453, 454, 455. 456, 457, 458 291, 292, 293. 190, 191, 192, 202, 203. 637, 638, 639. 461, 462. 391, 392. 533, 534, 535, 536. 377, 378, 379. 388, 389, 390. 480, 481, 482. 492, 493, 494. 329, 330, 331. 237, 238. 469, 470. 483. 537, 538, 551, 552, 553, 554, 555, 556, 557, 558, 559, 560, 561, 562, 563. 299, 300, 301. 640, 641. 485, 486, 487, 488, 489. 189, 204, 205, 206, 207, 208, 186, 187, 188. 252, 253, 254. 242, 243, 244. 258, 259, 260, 261, 262. 246, 247, 248, 249, 250, 251. 811, 812. 495, 496, 497, 498, 499. 682, 683, 684. 466, 467, 468. 870, 871, 872. 177, 178, 179, 193, 194, 195. 459, 460. 61, 62, 63, 64, 65, 66. 312. 69. 689, 690. Atherosclerosis ................................................................................................................................ Back and neck except spinal fusion ................................................................................................ Coronary artery bypass graft ........................................................................................................... Cardiac arrhythmia .......................................................................................................................... Cardiac defibrillator .......................................................................................................................... Cardiac valve ................................................................................................................................... Cellulitis ........................................................................................................................................... Cervical spinal fusion ...................................................................................................................... Chest pain ....................................................................................................................................... Combined anterior posterior spinal fusion ...................................................................................... Complex noncervical spinal fusion .................................................................................................. Congestive heart failure .................................................................................................................. Chronic obstructive pulmonary disease, bronchitis, asthma ........................................................... Diabetes ........................................................................................................................................... Double joint replacement of the lower extremity ............................................................................. Esophagitis, gastroenteritis, and other digestive disorders ............................................................ Fractures of the femur and hip or pelvis ......................................................................................... Gastrointestinal hemorrhage ........................................................................................................... Gastrointestinal obstruction ............................................................................................................. Hip and femur procedures except major joint ................................................................................. Lower extremity and humerus procedure except hip, foot, femur .................................................. Major bowel procedures .................................................................................................................. Major cardiovascular procedure ...................................................................................................... Major joint replacement of the lower extremity ............................................................................... Major joint replacement of the upper extremity .............................................................................. Medical noninfectious orthopedic .................................................................................................... tkelley on DSK3SPTVN1PROD with PROPOSALS2 Medical peripheral vascular disorders ............................................................................................. Nutritional and metabolic disorders ................................................................................................. Other knee procedures .................................................................................................................... Other respiratory .............................................................................................................................. Other vascular surgery .................................................................................................................... Pacemaker ....................................................................................................................................... Pacemaker device replacement or revision .................................................................................... Percutaneous coronary intervention ................................................................................................ Red blood cell disorders .................................................................................................................. Removal of orthopedic devices ....................................................................................................... Renal failure .................................................................................................................................... Revision of the hip or knee ............................................................................................................. Sepsis .............................................................................................................................................. Simple pneumonia and respiratory infections ................................................................................. Spinal fusion (noncervical) .............................................................................................................. Stroke .............................................................................................................................................. Syncope and collapse ..................................................................................................................... Transient ischemia .......................................................................................................................... Urinary tract infection ...................................................................................................................... b. Considerations for Potential Model Expansion In this FY 2016 IPPS/LTCH PPS proposed rule, we are soliciting public comments regarding policy and operational issues related to a potential expansion of the BPCI initiative in the VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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 PO 00000 Frm 00094 Fmt 4701 Sfmt 4702 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 E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 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. Evaluation of the BPCI initiative for expansion is expected to include analyses based on a combination of qualitative and quantitative sources, including Medicare claims, patient surveys, awardee reports, interviews, and site visits. Given that further evaluation of the BPCI initiative is needed to determine its impact on both Medicare cost and quality of care, at this time, we are not proposing an expansion of any models within the initiative or any policy changes associated with it. Instead, we are requesting public comments on issues surrounding a potential expansion of the BPCI initiative so that we can be prepared in the event that the Secretary determines that findings from the evaluation of the initiative demonstrate that it meets all criteria for expansion, consistent with the requirements of section 1115A(c) of the Act, and that, based on these findings and other pertinent factors, expansion is warranted. CMS is committed to testing new payment and service delivery models, evaluating results and advancing best practices, and engaging stakeholders. These three priorities are crucial to the BPCI initiative. As we initiate discussions about potential expansion, we continue to value stakeholder engagement within the framework of CMS’ priorities for the BPCI initiative. Consistent with its ongoing commitment to develop new models and refine existing models based on additional information and experience, CMS may modify existing models or test additional models under its testing authority under section 1115A of the Act. It may possibly do so, taking into consideration stakeholder input, including feedback received through the public comments submitted in response to the discussion in this section. However, the primary goal for this solicitation of public comments is to receive information about a potential expansion of the BPCI initiative. Therefore, we are requesting that public VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 comments on the discussion in this section consider how expanded episode payment could continue to encourage high-quality, high-value care during Medicare beneficiaries’ episodes of care, while allowing for accurate payments to providers, encouraging coordination of care among providers, and ensuring access to care and freedom of choice for all Medicare beneficiaries, regardless of their severity of illness. The following list is not an exhaustive list of issues on which we are requesting public comments, and the inclusion of the list of issues is not, in any way, meant to imply that any or all of these issues would be addressed in any expanded model. The solicitation of public comments is for planning purposes, and as mentioned above, we would use additional rulemaking if we decide to expand any of the models. We are seeking public comments on the following issues: • Breadth and scope of an expansion. For example, whether model expansion should focus on one or more of the four models or one or more specific episodes, or should target specific geographic regions of the country. Further, would the model best be expanded with voluntary participation or be most effective if participation were required within the chosen models, episodes, and regions. • Episode definitions. We are seeking public comments on the current BPCI initiative episode definitions as part of an expansion, including the MS–DRGs, other bundled services (such as hospital readmissions), exclusions, and the duration of the episodes. The BPCI initiative uses broadly defined episodes, and these episodes include MS–DRGs that account for approximately 80 percent of Medicare hospital discharges. Depending on the model, lengths of episodes may be 30, 60, or 90 days. Under all models within the BPCI initiative, these episode definitions have been standardized across models for episodes that relate to an acute care hospital stay. An expansion might target episodes beginning with inpatient hospital care or postacute care. We are seeking public comments regarding whether episode definition refinements should be made; for example, refinements potentially could be made for episodes that begin with postacute care to incorporate the findings from standardized patient assessments at postacute care initiation, rather than tying the episode to the hospital discharge diagnosis. • Models for expansion. We are seeking public comments on whether we should consider one or more of the current BPCI initiative models as the PO 00000 Frm 00095 Fmt 4701 Sfmt 4702 24417 first candidates for expansion. For example, under a model expansion, we potentially could expand several or all of the models that include postacute care on a similar timeframe or one model at a time. • Roles of organizations and relationships necessary or beneficial to care transformation. We are seeking public comments on the roles that organizations, including health care providers and suppliers and other entities, should serve under an expanded model. Within this category, we are seeking public comments specifically on the types of relationships and arrangements, financial or otherwise, that would assist participants with care transformation in an expanded model. We would appreciate any public comments on whether relationships encouraged under an expansion could have unintended consequences and what those consequences might be. • Setting bundled payment amounts. We are seeking public comments on approaches to setting bundled payments under model expansion. For participants in the BPCI initiative, bundled payments are related to the historical episode experience of episode initiators based on data from 2009 through 2012. In the BPCI initiative, only Model 4 rates are set prospectively, while Models 2 and 3 involve trending of target amounts following the conclusion of episodes. We potentially could base payments on regional episode experience or set all payments prospectively under model expansion. We potentially could apply the same episode discount percentages to all episodes or vary these discount percentages based on care redesign opportunity in the specific episode. We potentially could rebase payments annually or on another timeframe. In the case of setting payment amounts via a specified discount percentage, we are seeking public comments on methodologies that could be used to determine the discount percentages. We also are seeking public comments on any other methodologies that could be considered for the purposes of setting bundled payment amounts. • Mitigating risk of high-cost cases. Depending on the breadth and scope of an expansion, the potential financial impact of high-cost episode cases could be an issue for some providers. Currently, under the BPCI initiative, we apply a variety of approaches to risk mitigation, including allowing participants to select risk corridors that limit the inclusion of high-cost cases in episodes. We are seeking public comments on strategies to mitigate the E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 24418 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules risk of high-cost cases to ensure appropriate payment for these episodes under model expansion, such as through outlier or other policies, while encouraging high-value, coordinated care for these cases as well. For example, under model expansion, we potentially could establish an outlier pool with specific payment policies, similar to approaches under the IPPS and the OPPS. • Administering bundled payments. We are seeking public comments on the issues related to prospective or retrospective payment under model expansion. Currently, Model 4 under the BPCI initiative makes a single bundled payment, while Models 2 and 3 utilize routine Medicare FFS payments to all providers and supplies with retrospective reconciliation for the awardee. We are interested in public comments on the feasibility of different payment approaches under the various models, including the administrative capacity and feasibility for some organizations to pay others for care during episodes or to share payments at reconciliation. For example, under model expansion, we potentially could make a single bundled payment in all models, but we would need to identify the entity to receive the payments and engage in widespread changes to the shared systems to accommodate all payment systems. Under the BPCI initiative, we have agreements with multiple types of entities, including awardee conveners, that may not be Medicare providers or suppliers. We are requesting comments on the possibility of paying an awardee convener the bundled payment when that entity did not actually deliver health care services to the beneficiaries in episodes in an expanded model. Specifically, we would like to know what operational and policy considerations would need to be addressed. A retrospective reconciliation would have different concerns than a prospective payment. • Data needs. We are seeking public comments on the types of data and functionality needed in the marketplace in order to expand this type of model (for example, EHRs and quality measurement, among others). We currently provide monthly episode claims data to BPCI initiative participants for purposes of health care operations and periodic monitoring reports. Under model expansion, providers that are not fully integrated may need to develop approaches to sharing information regarding patients initiating and participating in episodes. Real-time information may improve the coordination of care. VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 • Use of health information technology. We are seeking public comments on how the use of health information technology can be used and encouraged in coordinating care across care settings, including postacute care. Health information technology and health information exchange may be used to support these models by sharing summaries of care, problem lists, physician orders, prescription lists, and care plans across the care continuum. We welcome public comments on how to include SNFs, LTCHs, IRFs, and HHAs that do not currently utilize health information technology and health information exchange at an advanced level without compromising the coordination of care among acute care hospitals and postacute care providers. • Quality measurement and payment for value. We are seeking public comments on the quality measures that could be applied to episodes and approaches to incorporating value-based payment in the BPCI initiative. For example, under model expansion, we potentially could apply the same quality measures to all episodes or develop episode-specific quality measures. We potentially could incorporate valuebased payment under model expansion by reducing the discount percentage for high quality care or increasing the discount percentage for low quality care. • Transition from Medicare FFS payments to bundled payments. We are seeking public comments on the need for and parameters of a transition period from Medicare FFS payment to bundled payment under an expanded model. We are seeking public comments regarding the length of any transition and how such a transition would be made. • Other issues. We are seeking public comments on any other issues the public believes are important for us to consider. Consistent with our continuing commitment to engaging stakeholders in CMS’ work, we are seeking public comments on these issues to broaden and deepen our understanding of the important issues and challenges regarding bundled payments in the current health care marketplace. These public comments also will assist us in planning for expansion if a decision is made to expand the BPCI initiative in the future. I. Proposed Add-On Payments for New Services and Technologies 1. Background Sections 1886(d)(5)(K) and (L) of the Act establish a process of identifying PO 00000 Frm 00096 Fmt 4701 Sfmt 4702 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 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 § 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 E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules regarding substantial similarity in detail. Under the second criterion, § 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, 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. Table 10 that was released with the FY 2015 IPPS/LTCH PPS final rule contains the final thresholds that we use to evaluate applications for new technology add-on payments for FY 2016. We refer readers to the CMS Web site at: https://www.cms.gov/Medicare/ Medicare-Fee-for-Service-Payment/ AcuteInpatientPPS/FY2015-IPPS-FinalRule-Home-Page-Items/FY2015-FinalRule-Tables.html to download and view Table 10. We note that later in this section under the discussion of the WATCHMAN® Left Atrial Appendage (LAA) Closure technology, we are soliciting public comments on the use of supplemental threshold values when the coding to identify a new technology is reassigned to a new MS–DRG that does not have a threshold value displayed in the most recent version of 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 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, § 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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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 § 412.88, if the costs of the discharge (determined by applying cost-to-charge ratios (CCRs) as described in § 412.84(h)) exceed the full DRG payment (including payments for IME and DSH, but excluding outlier payments), Medicare will make an addon payment equal to the lesser of: (1) 50 percent of the estimated costs of the new technology (if the estimated costs for the case including the new technology 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. 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 § 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 also amended § 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 PO 00000 Frm 00097 Fmt 4701 Sfmt 4702 24419 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 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 cochaired 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 claimspayment 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 highquality, 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. 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 userfriendly format. This guide was published in 2010 and is available on the CMS Web site at: https:// 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 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. E:\FR\FM\30APP2.SGM 30APP2 24420 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules tkelley on DSK3SPTVN1PROD with PROPOSALS2 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: https://www.cms.gov/ Medicare/Medicare-Fee-for-ServicePayment/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 AddOn 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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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 addon payment applications for FY 2016 in this 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 summarize these comments in the preamble of this proposed rule or, if applicable, indicate that there were no comments received, at the end of each discussion of the individual applications in this proposed rule. One commenter provided comments that were unrelated to the ‘‘substantial clinical improvement’’ criterion. As explained above and in the Federal Register notice announcing the New Technology Town Hall meeting (79 FR PO 00000 Frm 00098 Fmt 4701 Sfmt 4702 69490 through 69492), the purpose of the meeting was specifically to discuss the substantial clinical improvement criterion in regard to pending new technology add-on payment applications for FY 2016. Therefore, we are not summarizing the commenter’s comments in this proposed rule. The commenter is welcome to resubmit its comments in response to proposals presented in this proposed rule. Comment: One commenter stated that antibiotics are unique because their development and use present many challenges that are not applicable to other drugs or devices seeking approval for new technology add-on payments. The commenter urged CMS to utilize the expertise of the infectious diseases community when determining how to evaluate applications for new antibiotics for new technology add-on payments. The commenter further stated that because superiority studies cannot be conducted for most serious infections, the most appropriate evaluation of superiority for many new antibiotics is a ‘‘noninferiority’’ clinical trial, which is designed to determine if the experimental drug is similar in efficacy to a standard drug currently available on the market. The commenter noted that, recently, the FDA has demonstrated increased willingness to consider approving new antibiotics if efficacy can be proven based on achieved, welldefined, and statistically validated noninferiority margins. The commenter encouraged CMS to consider the proven efficacy of these antibiotics based on these criteria when determining whether to approve a new antibiotic for new technology add-on payment. The commenter also urged CMS to consider carefully analyzed and peer-reviewed safety, utilization, and economics data when such data are available to support the approval of a new antibiotic for new technology add-on payment. The commenter believed that these considerations could increase the types of information that would be used to support the approval of new drugs for which superiority trials are inappropriate or not feasible or both. The commenter also believed it is critical that CMS maintain an ongoing dialogue with the FDA as well as nongovernment experts in antibiotic resistance and antibiotic drug development in order to more fully understand the highly complex and unique issues regarding the type of data available for the study and approval of new antibiotics. Response: In our evaluation of new technology applications, we rely on the recommendations of our clinical advisors. We also consider all clinical E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules tkelley on DSK3SPTVN1PROD with PROPOSALS2 data provided by the applicant in our determination of whether a technology is eligible for new technology add-on payments. In addition, we summarize each application and invite the public to provide their comments and expertise on any new technology application under consideration during the comment period for the proposed rule. We also work with the FDA in instances where guidance is necessary to understand the complexities of a new technology. We appreciate the commenter’s input, and we will further consider these comments in future rulemakings. We note that the commenter provided comments that were unrelated to the substantial clinical improvement criterion. As noted above, the purpose of the new technology town hall meeting was specifically to discuss the substantial clinical improvement criterion in regard to pending new technology add-on payment applications for FY 2016. Therefore, we are not summarizing these comments in this proposed rule. The commenter is welcome to resubmit its comments in response to proposals presented in this proposed rule. 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 proposed rule, health plans and providers 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 will continue to use ICD–9–CM coding practices and principles through September 30, 2015. We refer readers to section II.G.1.a. of the preamble of this proposed 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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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. An overview of Section ‘‘X’’ codes was provided at the March 18–19, 2015 ICD– 10 Coordination and Maintenance Committee meeting. 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: https://www.cms.gov/Medicare/Coding/ ICD9ProviderDiagnosticCodes/ICD-9CM-C-and-M-Meeting-Materials.html through the ‘‘CMS Coordination and Maintenance Committee Meeting’’ link. The ICD–10–PCS includes a new section containing the new Section ‘‘X’’ codes, which will be used beginning FY 2016. 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 PO 00000 Frm 00099 Fmt 4701 Sfmt 4702 24421 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 Section ‘‘X’’ codes will be posted in June 2015 on the Internet via the CMS Web site at: https://www.cms.gov/ Medicare/Coding/ICD10/ under the links on the left side of the Web page. 4. Proposed FY 2016 Status of Technologies Approved for FY 2015 Add-On Payments a. Glucarpidase (Voraxaze®) BTG International, Inc. submitted an application for new technology add-on payments for Glucarpidase (Voraxaze®) 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. Voraxaze® was approved by the FDA on January 17, 2012. Beginning in 1993, certain patients could obtain expanded access for treatment use to Voraxaze® as an investigational drug. Since 2007, the applicant has been authorized to recover the costs of making Voraxaze® 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). Voraxaze® 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 Voraxaze® 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 Voraxaze® to be ‘‘new’’ as of April 30, 2012, which is the date of market availability. After evaluation of the newness, costs, and substantial clinical improvement criteria for new technology payments for Voraxaze® and consideration of the public comments we received in response to the FY 2013 IPPS/LTCH PPS proposed rule, we approved Voraxaze® for new technology add-on payments for FY 2013. Cases of Voraxaze® are identified with ICD–9– CM procedure code 00.95 (Injection or E:\FR\FM\30APP2.SGM 30APP2 24422 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules tkelley on DSK3SPTVN1PROD with PROPOSALS2 infusion of glucarpidase). As stated in the FY 2015 IPPS/LTCH PPS final rule correction notice (79 FR 59679), the cost of Voraxaze® 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 Voraxaze® is $94,500 ($23,625 × 4). Under § 412.88(a)(2), new technology add-on payments are limited 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 Voraxaze® 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’’ (§ 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 Voraxaze®, we considered the beginning of the newness period to commence when Voraxaze® was first made available on the U.S. market on April 30, 2012. Because the 3-year anniversary date for Voraxaze® 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) occurs prior to the beginning of FY 2016. Therefore, we are proposing to discontinue new technology add-on payments for Voraxaze® for FY 2016. We are inviting public comments on this proposal. b. Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Cook® Medical submitted an application for new technology add-on payments for the Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft (Zenith® F. Graft) for FY 2013. The applicant stated that the current treatment for patients who have VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 had an AAA is an endovascular graft. The applicant explained that the Zenith® 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 Zenith® 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 Zenith® F. Graft was approved by the FDA on April 4, 2012, we believed that the Zenith® 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 Zenith® F. Graft and consideration of the public comments we received in response to the FY 2013 IPPS/LTCH PPS proposed rule, we approved the Zenith® F. Graft for new technology add-on payments for FY 2013. Cases involving the Zenith® 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 Zenith® F. Graft. The total cost of the Zenith® F. Graft utilizing bare metal (renal) alignment stents was $17,264. Of the $17,264 in costs for the Zenith® 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 do 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 Zenith® F. Graft. Therefore, the total maximum cost for the Zenith® F. Graft is $16,343 ($17,264–$921). Under § 412.88(a)(2), new technology add-on payments are limited 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 Zenith® F. Graft is $8,171.50. PO 00000 Frm 00100 Fmt 4701 Sfmt 4702 With regard to the newness criterion for the Zenith® F. Graft, we considered the beginning of the newness period to commence when the Zenith® F. Graft was approved by the FDA on April 4, 2012. Because the 3-year anniversary date of the entry of the Zenith® 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 addon 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) occurs prior to the beginning of FY 2016. Therefore, we are proposing to discontinue new technology add-on payments for the Zenith® F. Graft for FY 2016. We are inviting public comments on this proposal. c. 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 E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 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. 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 × 5). Under § 412.88(a)(2), new technology add-on payments are limited 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. VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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) of this section)’’ 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: https://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) PO 00000 Frm 00101 Fmt 4701 Sfmt 4702 24423 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 § 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: https:// www.cms.gov/Regulations-andGuidance/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 are proposing to continue new technology add-on payments for this technology for E:\FR\FM\30APP2.SGM 30APP2 24424 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules FY 2016. We are inviting public comments on this proposal. Because we are adopting the ICD–10 coding system, effective October 1, 2015, as discussed in section II.G.1.a. of the preamble of this proposed rule, for FY 2016, we are proposing to identify and make new technology add-on payments for cases involving the KcentraTM technology with ICD–10–PCS procedure code 30283B1 (Transfusion of nonautologous 4-factor prothrombin complex concentrate into vein, percutaneous approach). As stated above, 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. 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 proposed 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 can be downloaded from the CMS Web site at: https://cms.gov/ Regulations-and-Guidance/Guidance/ Manuals/Downloads/clm104c03.pdf. The maximum new technology add-on payment for a case involving the KcentraTM technology would remain at $1,587.50 for FY 2016. We are inviting public comments on this proposal. tkelley on DSK3SPTVN1PROD with PROPOSALS2 d. Argus® II Retinal Prosthesis System Second Sight Medical Products, Inc. submitted an application for new technology add-on payments for the Argus® II Retinal Prosthesis System (Argus® II System) for FY 2014. The Argus® 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 Argus® 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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 approximately 4 hours and is performed under general anesthesia. The Argus® 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 Argus® 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 Argus® 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 PO 00000 Frm 00102 Fmt 4701 Sfmt 4702 connected to a ‘‘Psychophysical Test System’’ to evaluate patients’ performance with the Argus® 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 Argus® 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 Argus® 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 Argus® 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 Argus® 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 Argus® 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 Argus® 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 E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 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 Argus® II System first became available for commercial sale in the United States was December 20, 2013. We agreed with the applicant that, due to the delay, the date of newness for the Argus® 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 Argus® 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 Argus® 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 Argus® II System met all of the new technology add-on payment policy criteria. Therefore, we approved the Argus® II System for new technology add-on payments in FY 2014 (78 FR 50580 through 50583). Cases involving the Argus® 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 Argus® II System. The total operating cost of the Argus® II System is $144,057.50. Under VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 § 412.88(a)(2), new technology add-on payments are limited 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 Argus® II System for FY 2014 was $72,028.75. With regard to the newness criterion for the Argus® II System, we considered the beginning of the newness period to commence when the Argus® II System became available on the U.S. market on December 20, 2013. Because the 3-year anniversary date of the entry of the Argus® II System on the U.S. market will occur in the first half of FY 2017 (December 23, 2016), we are proposing to continue new technology add-on payments for this technology for FY 2016. We are inviting public comments on this proposal. Because we are adopting the ICD–10 coding system, effective October 1, 2015, as discussed in section II.G.1.a. of the preamble of this proposed rule, for FY 2016, we are proposing to identify and make new technology add-on payments for cases involving the Argus® 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). The maximum new technology add-on payment for a case involving the Argus® II System would remain at $72,028.75 for FY 2016. We are inviting public comments on this proposal. e. Zilver® PTX® Drug Eluting Peripheral Stent Cook® Medical submitted an application for new technology add-on payments for the Zilver® PTX® Drug Eluting Peripheral Stent (Zilver® PTX®) for FY 2014. The Zilver® PTX® 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 selfexpanding, 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 PO 00000 Frm 00103 Fmt 4701 Sfmt 4702 24425 risk of renarrowing of the coronary arteries after stenting procedures. The applicant received FDA approval on November 15, 2012, for the Zilver® PTX®. The applicant maintains that the Zilver® PTX® 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 addon payment application and consideration of the public comments received, we approved the Zilver® PTX® for new technology add-on payments in FY 2014. Cases involving the Zilver® PTX® 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 Zilver® PTX® 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 Zilver® PTX® Global Registry Clinical Study. The applicant stated in its application that the anticipated cost per stent is approximately $1,795. Therefore, cases of the Zilver® PTX® would incur an average cost per case of $3,410.50 ($1,795 × 1.9). Under § 412.88(a)(2), new technology add-on payments are limited 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 Zilver® PTX® was $1,705.25 for FY 2014. With regard to the newness criterion for the Zilver® PTX®, we considered the beginning of the newness period to commence when the Zilver® PTX® was approved by the FDA on November 15, 2012. Because the 3-year anniversary date of the entry of the Zilver® PTX® 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 are proposing to discontinue new technology add-on payments for the Zilver® PTX® for FY 2016. We are inviting public comments on this proposal. E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 24426 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules f. 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, VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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 addon 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 § 412.88(a)(2), new technology add-on payments are limited 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 are proposing to continue new technology add-on payments for this technology for FY 2016. We are inviting public comments on this proposal. Because we are adopting the ICD–10 coding system, effective October 1, PO 00000 Frm 00104 Fmt 4701 Sfmt 4702 2015, as discussed in section II.G.1.a. of the preamble of this proposed rule, for FY 2016, we are proposing 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). The maximum payment for a case involving the CardioMEMSTM HF Monitoring System would remain at $8,875 for FY 2016. We are inviting public comments on this proposal. g. MitraClip® System Abbott Vascular submitted an application for new technology add-on payments for the MitraClip® System for FY 2015. The MitraClip® System is a transcatheter mitral valve repair system that includes a MitraClip® 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 MitraClip® 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 E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules expected benefit from correction of the mitral regurgitation.’’ The MitraClip® System mitral valve repair procedure is based on the doubleorifice 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 MitraClip® System received a premarket approval from the FDA on October 24, 2013. The MitraClip® 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 MitraClip® System became immediately available on the U.S. market following FDA approval. The MitraClip® 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 MitraClip® 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: https:// www.cms.gov/medicare-coveragedatabase/details/nca-trackingsheet.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 MitraClip® System and VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 consideration of the public comments we received in response to the FY 2015 IPPS/LTCH PPS proposed rule, we approved the MitraClip® 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 MitraClip® consistent with the NCD. Cases involving the MitraClip® 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 MitraClip® System is reported as $30,000. Under section 412.88(a)(2), new technology add-on payments are limited 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 MitraClip® System is $15,000 for FY 2015. With regard to the newness criterion for the MitraClip® System, we considered the beginning of the newness period to commence when the MitraClip® System was approved by the FDA on October 24, 2013. Because the 3-year anniversary date of the entry of the MitraClip® System on the U.S. market will occur in FY 2017 (October 24, 2016), we are proposing to continue new technology add-on payments for this technology for FY 2016. We are inviting public comments on this proposal. Because we are adopting the ICD–10 coding system, beginning October 1, 2015, as discussed in section II.G.1.a, of the preamble of this proposed rule, for FY 2016, we are proposing to identify and make new technology add-on payments for cases involving the MitraClip® System using ICD–10–PCS procedure code 02UG3JZ (Supplement mitral valve with synthetic substitute, percutaneous approach). The maximum payment for a case involving the MitraClip® System would remain at $15,000 for FY 2016. We are inviting public comments on this proposal. h. Responsive Neurostimulator (RNS®) System NeuroPace, Inc. submitted an application for new technology add-on payments for FY 2015 for the use of the RNS® 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. PO 00000 Frm 00105 Fmt 4701 Sfmt 4702 24427 According to the applicant, the RNS® 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 RNS® 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 RNS® 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 RNS® 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 RNS® System and consideration of the public comments we received in response to the FY 2015 IPPS/LTCH PPS proposed rule, we approved the RNS® System for new technology addon payments for FY 2015 (79 FR 49950). Cases involving the RNS® 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 E:\FR\FM\30APP2.SGM 30APP2 24428 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules generator) in combination with 02.93 (Implantation or replacement of intracranial neurostimulator lead(s)). According to the applicant, cases using the RNS® System would incur an anticipated cost per case of $36,950. Under § 412.88(a)(2) of the regulations, new technology add-on payments are limited 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 RNS® System is $18,475. With regard to the newness criterion for the RNS® System, we considered the beginning of the newness period to commence when the RNS® System was approved by the FDA on November 14, 2013. Because the 3-year anniversary date of the entry of the RNS® System on the U.S. market will occur in FY 2017 (November 14, 2016), we are proposing to continue new technology add-on payments for this technology for FY 2016. We are inviting public comments on this proposal. Because we are adopting the ICD–10 coding system effective October 1, 2015, as discussed in section II.G.1.a. of the preamble of this proposed rule, we are proposing to identify and make new technology add-on payments for cases involving the RNS® 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 RNS® System would remain at $18,475 for FY 2016. We are inviting public comments on this proposal. tkelley on DSK3SPTVN1PROD with PROPOSALS2 5. FY 2016 Applications for New Technology Add-On Payments We received applications for nine new technology add-on payments for FY 2016. In accordance with the regulations under § 412.87(c), applicants for new technology add-on payments must have FDA approval by July 1 of each year prior to the beginning of the fiscal year that the application is being considered. A discussion of the applications is presented below. a. Angel Medical Guardian® Ischemic Monitoring Device Angel Medical Systems, Inc. submitted an application for new technology add-on payments for the Angel Medical Guardian® Ischemic Monitoring Device (hereinafter referred to as the Guardian®). The Guardian® implantable ischemia detection system is designed to provide early detection VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 and patient alerts for ischemic and other cardiac events experienced by ambulatory patients. The device consists of an implantable monitoring device (IMD) that communicates with an external device (EXD) via telemetry. The IMD monitors the patient’s current cardiac data and compares these data to the patient’s historical baseline using thresholds that reflect the normal ischemic range for each individual. Upon detection of a cardiac anomaly, the implanted IMD vibrates and provides one of two distinguishable alerts, ‘‘emergency alarms’’ and ‘‘see doctor alerts,’’ which prompt the patient to initiate emergency and/or preventative actions. The system also includes a program that allows physicians to adjust the settings for event detection and subsequent alerts. With respect to the newness criterion, the applicant anticipates FDA premarket approval during June 2015. The Guardian® technology is a Class III device that has obtained an investigational device exemption (IDE) from the FDA under IDE number G060259. Effective October 1, 2006 (FY 2007), ICD–9–CM procedure codes 00.56 (Insertion or replacement of implantable pressure sensor (lead) for intracardiac hemodynamic monitoring) and 00.57 (Implantation or replacement of subcutaneous device for intracardiac hemodynamic monitoring) were created to describe specific types of cardiac procedures. There have been minor revisions to each of the procedure codes’ title and description over the years to better differentiate procedures being performed with various technologies. As of October 1, 2011 (FY 2012), these codes distinguish procedures using the Guardian® technology from other similar procedures that use various technologies. The current ICD–9–CM procedure code titles are as follows: 00.56 (Insertion or replacement of implantable pressure sensor with lead for intracardiac or great vessel hemodynamic monitoring), and 00.57 (Implantation or replacement of subcutaneous device for intracardiac or great vessel hemodynamic monitoring). As stated earlier in section II.G.1.a. of the preamble of this proposed rule, effective October 1, 2015 (FY 2016), the ICD–10 coding system will be implemented. Under ICD–10, procedure code 02HK32Z (Insertion of monitoring device into right ventricle, percutaneous approach) is the comparable translation for ICD–9–CM procedure code 00.56, and procedure code 0JH602Z (Insertion of monitoring device into chest subcutaneous tissue and fascia, open PO 00000 Frm 00106 Fmt 4701 Sfmt 4702 approach) is the comparable translation for ICD–9–CM procedure code 00.57, which specifically describe procedures involving the Guardian® technology. We note that, in accordance with § 412.87(c), in order for a technology to be considered for new technology addon payments for a particular fiscal year, the technology must be approved by the FDA by July 1 prior to the particular fiscal year for which add-on payments are requested. According to the applicant, there are no other treatment modalities that perform the same function as the Guardian® technology. Therefore, the applicant believed that the Guardian® technology is not substantially similar to any other currently approved technology. We are inviting public comments on whether the Guardian® technology meets the newness criterion. With respect to the cost criterion, the applicant determined that cases involving the Guardian® technology map to MS–DRG 264 (Other Circulatory System O.R. Procedures). The applicant initially provided a sensitivity analysis performed using all of the cases assigned to MS–DRG 264, without isolating a subset of cases that would be eligible for treatment using the Guardian® technology. In follow up to our request for a more focused analysis that calculates an average case-weighted standardized charge per case for cases involving the Guardian® technology assigned to MS–DRG 264, the applicant submitted a revised analysis that used data from a subset of cases representing patients who received treatment involving the implantation of pacemakers that mapped to MS–DRG 243 (Pacemaker Implant with CC). The applicant searched the Healthcare Cost and Utilization Project (HCUP) database for patient profiles that indicated prior myocardial infarction with comorbidities such as malignant hypertension (reported using ICD–9–CM diagnosis code 401.0), other acute and subacute forms of ischemic disease (reported using ICD–9–CM diagnosis code 411.89), and intermediate coronary syndrome (that is, unstable angina reported using ICD–9–CM diagnosis code 411.1). According to the applicant, all of the patients enrolled in the ALERTS pivotal clinical study exhibited at least one or more of these comorbidities, similar to many of the patients represented by cases assigned to MS–DRG 243. The applicant asserted that the results from the revised search of the HCUP database revealed patient profiles that were similar to the patients who would have likely been recommended for treatment using the E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules Guardian® technology, which are represented by the cases assigned to MS–DRG 264. The applicant identified 843 cases assigned to MS–DRG 243, which represents patients treated with pacemaker implantations by the hospitals that participated in the Guardian® ALERTS clinical study. The applicant used data from multiple sources to compute an average case-weighted standardized charge per case for procedures involving the Guardian® technology. The applicant began by determining the specific FY 2015 Medicare IPPS Federal rate for cases assigned to MS–DRG 243 that were treated by each hospital that participated in the Guardian® ALERTS clinical study. The applicant then adjusted this amount by a factor of 1.057, which was derived from the March 2014 MedPAC Report to Congress on Medicare payment policies, to convert the Medicare payment to actual costs incurred by each hospital for each case. Specifically, the applicant determined this adjustment factor by subtracting the average industry wide margin of ¥5.4 percent, or ¥0.054 percent, for hospitals during 2012, which was reflected in the March 2014 Report to Congress, from a factor of 1, which results in the percentage of inpatient costs that Medicare paid (1¥0.054 = 94.6), and then divided this amount by 100 (100/94.6 = 1.057). To convert the adjusted Medicare payment amount to charges, the applicant applied hospital-specific CCRs found in the FY 2015 IPPS final rule impact file. The applicant computed an average case-weighted standardized charge per case by weighting the number of implants performed using the Guardian® technology performed by each hospital participating in the Guardian® ALERTS clinical study to the overall number of implants performed and represented by cases assigned to MS–DRG 243. This resulted in an average case-weighted standardized charge per case of $75,010. The applicant then deducted device-related charges for a pacemaker based on data obtained from the FY 2015 After Outliers Removed (AOR) File to determine the nonimplant resources used during these types of procedures, and added the device-related charges for the Guardian® technology, which resulted in an adjusted average caseweighted charge per case of $89,050. Because this adjusted average caseweighted standardized charge per case exceeds the average case-weighted threshold amount of $65,544 for MS– DRG 264 as displayed in Table 10 of the FY 2015 IPPS/LTCH PPS final rule, the VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 applicant maintained that the Guardian® technology meets the cost criterion. We have several concerns regarding the applicant’s cost analysis. We do not believe that it is appropriate to convert Medicare payments for discharges to actual costs incurred by hospitals by applying a margin adjustment factor and hospital-specific CCRs to determine an average case-weighted standardized charge for specific cases. According to the regulations under 42 CFR 412.2(b)(1), the prospective payment amount paid for inpatient hospital services is the total Medicare payment for the inpatient operating costs and the inpatient capital-related costs incurred in furnishing services covered by the Medicare program. The prospective payment amount represents a payment amount for the total cost of inpatient hospital services incurred by hospitals participating in the Medicare program, but does not represent a measure of the actual costs per case. For example, two hospitals in the same CBSA will be paid the same prospective payment amount for a case assigned to the same MS– DRG. The fact that these hospitals are paid the same prospective payment amount does not imply that the hospitals incurred the same amount of costs per case. On the contrary, the hospitals probably incurred very different costs for each case and the prospective payment amount is simply a payment for the inpatient costs covered by Medicare. Therefore, we are concerned about the methodology used by the applicant to determine an average case-weighted standardized charge per case, and do not believe that the calculation of this amount determined by the applicant is accurate. Moreover, we are concerned that the applicant assumed that the patient profiles for patient treated with pacemaker implantations and patients treated using the Guardian® technology are similar enough to warrant the inclusion of cases assigned to MS–DRG 243 in the analysis and then to depend upon the results of that analysis as a basis to demonstrate that the technology meets the cost criterion. In addition, we do not believe that it is appropriate to assume that the resources used during procedures involving pacemaker implantations and procedures involving the Guardian® technology would be the same, and the applicant does not provide a rationale for assuming such similarities. Because of these concerns, we are unable to determine if the technology meets the cost criterion. We are inviting public comments on whether the Guardian® technology meets the cost criterion, PO 00000 Frm 00107 Fmt 4701 Sfmt 4702 24429 particularly with respect to the concerns we have raised. With respect to the substantial clinical improvement criterion, the applicant asserted that this technology provides a more rapid beneficial resolution to ischemic and other cardiac events in ambulatory patients that reduces mortality and morbidity, and facilitates a faster patient presentation time to initiate treatment for these types of disorders. The applicant also believed that this technology fulfills an unmet clinical need for early diagnoses and preventative treatment options for a patient population that experiences silent, asymptomatic ischemia. The applicant included data from its pivotal ALERTS clinical trial, a randomized study expanding over a 6-month period of patients who were treated using the Guardian® technology and with the alarm function turned on (which represented the treatment group) or the alarm function turned off (which represented the control group). The primary efficacy endpoint was a composite variable that considered cardiac or unexplained death, new death Q-wave MI, or delayed presentation (time to door >2 hours) for a documented coronary occlusion event. The primary safety outcome measure was device-related complications. According to the applicant, the following findings demonstrate that the Guardian® technology represents a substantial clinical improvement in regard to currently available treatment options for Medicare beneficiaries: • The treatment group showed statistically significant clinical improvement over the control group using a composite outcome variable; • 97 percent of patients treated with implantations using the Guardian® technology were free from systemrelated complications at 6 months post programming; • A reduced proportion of patients having pre-hospital delays over 2 hours for a confirmed thrombotic coronary occlusive event; • A reduction in the median time-todoor for patients treated using the Guardian® technology alert system turned on (51 minutes) versus patients treated using the Guardian® technology alert system turned off (1,808 minutes); and • An improvement in the overall quality of life, and greater control over the condition, including feeling safer, for patients who were enrolled in the ALERTS trial and participated in a 2012 quality of life study that were treated with the Guardian® technology when the alarm system was activated. E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 24430 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules We are concerned that the outcome measures, including the quality of life measures, are based on and reflective of factors other than the efficacy of the device. For instance, any benefit from using the Guardian® technology depends entirely upon the patient heeding the alarms and alerts and seeking emergency medical care without delay. Moreover, we are concerned that the ALERTS pivotal trial uses inherently different methods of ascertainment of ‘‘delayed presentation’’ for the treatment group and the control group after an ischemic event, which implies a serious bias in regard to the clinical trial results. We believe that this bias questions the validity of the primary efficacy endpoint. An additional concern is that the ALERTS pivotal trial uses a very broad definition of a ‘‘confirmed thrombotic event.’’ Although the pivotal trial used four different criteria to determine whether such an event occurred, only two of them are actually evidence of an acute coronary event for which timely patient presentation for medical care might improve outcomes. The applicant did indicate how many confirmed events met each of the four criteria. We are inviting public comments on if, and how, the Guardian® technology meets the substantial clinical improvement criterion, particularly with respect to the concerns we have raised. Below we summarize and respond to the comments submitted on the Guardian® technology at the Town Hall meeting. Comment: Several participants in the ALERTS clinical trial submitted comments supporting the approval of new technology add-on payments for the Guardian® technology. According to the commenters, use of the Guardian® technology is associated with substantial clinical improvement of patients at high risk for a repeat myocardial infarction. The commenters stated that experiences as part of the ALERTS study have been positive. In addition, the commenters agreed with the applicant that patients implanted with an active Guardian® device who were alerted to a confirmed myocardial infarction event arrived at a medical facility significantly faster than those generally treated using the regular standard of care. Moreover, the commenters agreed with the applicant that patients are reassured by the effectiveness of the Guardian® device as a means of monitoring and protection. The commenters believed that the Guardian® device provides patients and providers with an important tool for helping to recognize when a significant VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 ischemic event occurs and when to seek prompt medical treatment, which result in reduced morbidity and mortality, fewer visits to the emergency room and unnecessary hospitalizations, and reduced health care expenditures. The commenters believed that the Guardian® device meets the substantial clinical improvement criterion because the device offers a more rapid and beneficial resolution for treating patients by its capability to diagnose a medical condition in a patient population where the condition is currently undetectable as well as offers a treatment option to a patient population unresponsive to currently available treatments. One commenter, a principal investigator in the ALERTS study, further reported that treatment using the Guardian® device tended to reduce the incidence of Q waves, a primary clinical endpoint that has important ramifications in both morbidity and mortality rates. The commenter also noted that, based on the results of the ALERTS study, asymptomatic thrombotic events were recognized in 21 of 451 (4.6 percent) of patients in the Guardian® treatment arm, and that the vast majority of these patients arrived to a medical facility within an hour of the onset of the event. In contrast, patients in the control arm who experienced asymptomatic ischemic events recorded by the Guardian® device arrived to a medical facility between 10 and 77 days after the event. According to the commenter, many of these patients experienced a silent myocardial infarction, which occurs over time in a significant number of patients and can lead to higher mortality rates. The commenter believed that the Guardian® device provides a significant benefit to a patient population that experiences asymptomatic ischemic events and does not receive any physical warnings of their condition, and who would otherwise not seek treatment for a longer period of time than what is recommended in the medical community, if treatment is sought at all. Another commenter provided additional information on the opportunity for improvement upon time to treatment for patients at high risk for a recurrent myocardial infarction, which would in turn lead to improved clinical outcomes, particularly for the patient population experiencing asymptomatic ischemia. According to the commenter, approximately 50 percent of patients experiencing myocardial infarction have no symptoms at all or symptoms that may not be recognized, and often do not receive any acute therapy to avert or mitigate the impact of the infarction. PO 00000 Frm 00108 Fmt 4701 Sfmt 4702 The commenter stated that the current standard of care requires patients to recognize symptoms of heart attack and seek medication immediately, and, for every 30 minute delay in treatment, there is an associated 8.5 percent increased risk of developing an ejection fraction of less than 30 percent, which is highly correlated with subsequent heart failure, and an associated 7.5 percent relative risk increase in 1 year mortality. Therefore, the commenter believed that the Guardian® device presents a significant opportunity to address improvement in the timing of treatment for patients at high risk for a recurrent myocardial infarction. Response: We appreciate the commenters’ input. We will take these comments into consideration when deciding whether to approve new technology add-on payments for the Guardian® device. b. Blinatumomab (BLINCYTOTM) Amgen, Inc. submitted an application for new technology add-on payments for Blinatumomab (BLINCYTOTM), a bispecific T-cell engager (BiTE) used for the treatment of Philadelphia chromosome-negative (Ph-) relapsed or refractory (R/R) B-cell precursor acutelymphoblastic leukemia (ALL), which is a rare aggressive cancer of the blood and bone marrow. Approximately 6,050 individuals are diagnosed with ALL in the United States each year, and approximately 2,400 individuals, which represents 30 percent of all new cases, are adults. 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 Tcell 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 Tcell 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 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. 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 E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 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 BLINCYTOTM 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 28day 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 this proposed rule, effective October 1, 2015 (FY 2016), the ICD–10 coding system will be implemented. We note that the applicant submitted a request for unique ICD–10–PCS codes that was presented at the March 18, 2015 ICD–10 Coordination and Maintenance Committee meeting. If approved, the codes will be effective on October 1, 2015 (FY 2016). More information on this request can be found on the CMS Web site located at: https:// www.cms.gov/Medicare/Coding/ ICD9ProviderDiagnosticCodes/ICD-9CM-C-and-M-Meeting-Materials.html. 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. However, we are concerned that BLINCYTOTM may be substantially similar to other bi-specific T-cell engagers. 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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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, we are concerned 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 MCSPspecific 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, we are concerned that the specificity of the mechanism of action may not be sufficient to distinguish the BLINCYTOTM technology from other bispecific T-cell engagers and, therefore, the technology bears substantial similarity to these other BiTEs used as current treatment options for Medicare beneficiaries. Further, we are concerned 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, 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 PO 00000 Frm 00109 Fmt 4701 Sfmt 4702 24431 of all cases representing patients diagnosed with 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, according to the applicant, the standard treatment for patients diagnosed with 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 commenter stated that, although chemotherapy is a successful treatment option to induce remission in patients diagnosed with R/ R ALL, many of these patients relapse or stop responding to this standard treatment and, therefore, are be 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 anticancer 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, we are concerned that this specific patient population is not necessarily distinguishable from the overall patient population of individuals diagnosed with ALL, and we are unsure how to identify these patients using administrative claims data. We believe that the BLINCYTOTM technology may be similar to other approved technologies currently available to treat the same patient E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 24432 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules population and medical disorders and, therefore, may not meet the newness criterion. In addition, we do not believe that the specific patient population targeted by the applicant is 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 are seeking public comments on if, and how, the BLINCYTOTM technology meets the newness criterion. 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 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 ALL. The cases assigned to the remaining 238 MS–DRGs represent a combined 42.1 percent of all cases representing patients diagnosed with ALL, with no single MS–DRG containing cases representing more than 2.0 percent of all cases representing patients diagnosed with 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 PPSexempt 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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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 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 caseweighted 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 PO 00000 Frm 00110 Fmt 4701 Sfmt 4702 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 caseweighted 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. We have three concerns regarding the applicant’s methodology and assumptions used in its cost analyses. We are concerned 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 are concerned that the applicant did not provide a basis for the hospital markup assumed when conducting its cost analyses. Unless the applicant provides this information, we are unable to determine whether the cost of the technology per case has been calculated appropriately. Moreover, we are concerned 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 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 causes us concern regarding whether the methodology used by the applicant in its cost analysis is appropriate. We are inviting public comments on if, and how, the E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules BLINCYTOTM technology meets the cost criterion, specifically in regard to our concerns related to the applicant’s methodology. 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 R/ R 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 (<12 months) at 4.7 months, and a median overall survival rate for patients experiencing second or later relapse at 3 months. However, there are several limitations to using recent literature as a historical comparison for studies relating to patients diagnosed with R/R ALL, including differences in patient populations or study design characteristics across published studies, which make it difficult to formulate absolute comparisons with regard to data obtained from the BLINCYTOTM 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 relapsed/ refractory ALL relative to patients treated using existing therapies. Simulations based on the MBMA for adult patients diagnosed with relapsed/ refractory B-precursor ALL projected a poor outcome with existing salvage VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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 relapsed/refractory 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 R/R 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 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 PO 00000 Frm 00111 Fmt 4701 Sfmt 4702 24433 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- 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 ALL. We are concerned 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 E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 24434 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules not randomized or blinded, and was comprised of a small sample group of 189 patients with a median age of 39 years. We are concerned 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 are concerned 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 agree with this assertion. However, 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 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. We also note 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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 technology reduces mortality rates, we note 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 note 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 are concerned 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 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 are inviting public comments on if, and how, the BLINCYTOTM technology meets the substantial clinical improvement criterion, specifically in regard our specified concerns. c. Ceftazidime Avibactam (AVYCAZ) Cerexa, Inc., an affiliate of Actavis, Inc., submitted an application for new technology add-on payments for FY 2016 for Ceftazidime Avibactam (AVYCAZ). AVYCAZ is used for the treatment of adult patients who have been diagnosed with complicated urinary tract Infections (cUTIs), including pyelonephritis and complicated Intra-abdominal Infections (cIAIs), for which there are limited or no available treatment options. Although AVYCAZ is indicated for the treatment of patients who have been diagnosed with cUTIs and cIAIs, the applicant asserted that the product may also be used in the treatment of patients diagnosed with cUTIs and cIAIs caused by extended-spectrum b-lactamase (ESBL)-producing Gram-negative pathogens, carbapenem-resistant Enterobacteriaceae (CRE), and multidrug-resistant (MDR) Pseudomonas aeruginosa. AVYCAZ is an intravenous b-lactam/ b-lactamase inhibitor combination antibacterial drug, consisting of an antipseudomonal, Cephalosporin (also referred to as Ceftazidime), and a blactamase inhibitor, Avibactam. Ceftazidime is currently available and widely used as an extended spectrum of PO 00000 Frm 00112 Fmt 4701 Sfmt 4702 Cephalosporin. However, in recent years Cephalosporin has had diminishing effects because of increasing levels of antibiotic resistance in specific bacteria. Some species of bacteria produce +lactamase enzymes, which cleave the +lactam in antibiotics such as penicillin that have a +-lactam ring in their structure. The +-lactamase enzymes inactivate the antibiotic and cause the bacteria to become resistant to that antibiotic. To avoid development of resistance, in current practices +lactamase inhibitors are administered in combination with +-lactam antibiotics to inhibit the action of +-lactamase enzymes and prevent the development of antibiotic resistance because +lactamase inhibitors block the activity of +-lactamase enzymes. This tends to widen the spectrum of antibacterial activity. For example, a commonly used b-lactamase inhibitor, Clavulanic acid or Clavulanate, is usually combined with Amoxicillin to create Augmentin or Ticarcillin (Timentin); Sulbactam (also a commonly used +-lactamase inhibitor) is usually combined with Ampicillin to create Cefoperazone; and Tazobactam is usually combined with Piperacillin. Ceftazidime is not combined with any b-lactamase inhibitors. Combining Ceftazidime with Avibactam prohibits bacteria from developing resistance to the antibiotic and protects Ceftazidime from being inactivated by b-lactamase enzymes. According to the applicant, unlike other inhibitors, Avibactam does not induce Class C enzymes that diminish the activity of Cephalosporin. Administering Ceftazidime in combination with Avibactam decreases the minimum inhibitory concentration (MIC) of Class A and Class C isolates, and some Class D isolates, thereby restoring the in vitro activity of Ceftazidime against these resistant isolates. AVYCAZ is administered as a treatment to patients 18 years of age, or older, who have been diagnosed with a cUTI and/or a cIAI in doses of 2.5g (2g of Ceftazidime and 0.5g of Avibactam), every 8 hours by intravenous infusion spanning over a 2-hour time period. The recommended duration of treatment with AVYCAZ for patients diagnosed with a cIAI (used in combination with Metronidazole) is 5 to 14 days as an inpatient. The recommended duration of treatment with AVYCAZ for patients diagnosed with a cUTI is 7 to 14 days as an inpatient. The FDA has authorized a randomized multi-center, activecontrolled trial to evaluate the safety and tolerability of AVYCAZ in children who are at least 3 months of age, and in adults 18 years of age or older who have been diagnosed with a cUTI and/or cIAI E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules as part of the post-marketing surveillance studies. The FDA also authorized and recommended a clinical trial to study the use of AVYCAZ in the treatment of patients who have been diagnosed with a cIAI and to generate phase 3 data as an effort to evaluate the pharmacokinetics, safety, and clinical outcomes of adult patients diagnosed with baseline renal impairment (creatinine clearance of 50 mL/min or less) who also are eligible for, or being treated with, AVYCAZ—adjusting dosage regimens to protect renal function. With regard to the newness criterion, AVYCAZ was approved by the FDA on February 25, 2015. As stated earlier in section II.G.1.a. of the preamble of this proposed rule, for FY 2016, effective October 1, 2015 (FY 2016), the ICD–10 coding system will be implemented. We note that the applicant submitted a request and presented at the September 2014 Coordination and Maintenance Committee Meeting to apply for ICD– 10–PCS codes that uniquely identify the administration of CeftazidimeAvibactam Anti-infective. More information on this request can be found on the CMS Web site at: https:// www.cms.gov/Medicare/Coding/ ICD9ProviderDiagnosticCodes/ICD-9CM-C-and-M-Meeting-Materials.html. Currently, ICD–10–PCS procedure codes 3E03329 (Introduction of other anti-infective into peripheral vein, percutaneous approach) and 3E04329 (Introduction of other anti-infective into central vein, percutaneous approach) describe the injection of an antibiotic. However, these ICD–10–PCS codes are not specific to the type of antibiotic used. We received public comments during and after the March 2015 ICD– 10 Coordination and Maintenance Committee meeting that supported the creation of a unique code to identify the AVYCAZ antibiotic when it is used in the treatment of patients who have been diagnosed with cUTIs and cIAIs. As a result, the following ICD–10–PCS codes were created under the new Section X to describe the specific use of AVYCAZ and are effective October 1, 2015 (FY 2016): XW03321 (Introduction of ceftazidime-avibactam anti-infective into peripheral vein, percutaneous approach, new technology group 1); and XW04321 (Introduction of ceftazidimeavibactam anti-infective into central vein, percutaneous approach, new technology group 1). If the AVYCAZ technology is approved for new technology add-on payments, we believe that the newness period would begin on February 25, 2015, the date of FDA approval. At this time, the applicant has not submitted any VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 information that suggests the technology was not available on the U.S. market as of the FDA approval date. The applicant maintained that AVYCAZ meets the newness criterion. We are inviting public comments on whether AVYCAZ meets the newness criterion. According to the applicant, the most current guidelines recommend treatment for patients hospitalized because of a cUTI diagnosis using antibiotic drugs such as Cefepime, Ceftriaxone, and Piperacillin/ Tazobactam.6 For patients who have been diagnosed with a cIAI and who are advanced in age, the most current guidelines recommend treatment using antibiotic drugs such as Imipenemcilastin, Meropenem, and Piperacillin/Tazobactam.7 We are concerned that AVYCAZ may be substantially similar to other currently available treatment options, which also are used in the treatment of these types of infections. 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. As stated by the applicant, Ceftazidime is currently available and widely used in the treatment of these types of infections. In addition, the current treatment options available to Medicare beneficiaries and used to treat this patient population include antibiotics such as Polymyxins (for example, Colistin), Aminoglycosides (for example, Amikacin and Gentamicin), Carbapenems (for example, Meropenem and Imipenem/ Cilastatin), or Tigecycline. The applicant maintained that the administration of Ceftazidime in combination with Avibactam broadens 6 Drugs for urinary tract infections. JAMA. 2014;311(8):855–6. Available at: https:// jama.jamanetwork.com/ article.aspx?articleid=1832532. 7 Solomkin JS et al. Guidelines by the Surgical Infection Society and the Infectious Diseases Society of America. Clin Infect Dis. 2010;50(2):133– 64. Available at: https://cid.oxfordjournals.org/ content/50/2/133.full. PO 00000 Frm 00113 Fmt 4701 Sfmt 4702 24435 the spectrum of +-lactamase inhibition when compared to administering Ceftazidime without Avibactam and other currently available therapies because Avibactam has inhibiting agents that restore the in vitro activity of Ceftazidime that is sometimes decreased when encountered by common Class A and Class C isolates and some Class D isolates. The applicant also asserted that the technology may be used to treat patients who have been diagnosed with cUTIs and/or cIAIs caused by extendedspectrum b-lactamase (ESBL)-producing Gram-negative pathogens, Klebsiella pneumoniae carbapenemase (KPC), carbapenem-resistant Enterobacteriaceae (CRE), and multidrug-resistant (MDR) Pseudomonas aeruginosa. However, we believe that the mechanism of action of AVYCAZ is the same as the mechanism of action of Ceftazidime because both drugs rely upon Cephalosporin to achieve a successful therapeutic outcome. Further, we are concerned that AVYCAZ involves the treatment of the same or similar type of disease and the same or similar patient population as other currently approved treatment options. Therefore, we believe that AVYCAZ bears a substantial similarity to Ceftazidime and other currently available treatment options. We are inviting public comments regarding whether AVYCAZ meets the newness criterion, specifically with regard to the substantial similarity criteria. 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 cost criterion, the applicant maintained that AVYCAZ meets the cost criterion. According to the applicant, there are 63 ICD–9–CM diagnosis codes that describe cUTIs and/or cIAIs. Cases representing patients who have been diagnosed with cUTIs and/or cIAIs may be reported on hospital claims using any 1 of 12 different ICD–9–CM diagnosis codes describing cUTIs, and any 1 of 51 ICD– 9–CM diagnosis codes describing cIAIs. Therefore, cases representing patients diagnosed with either a cUTI or a cIAI may be assigned to multiple MS–DRGs. Of the 63 applicable ICD–9–CM diagnosis codes, the applicant used 35 ICD–9–CM codes to identify 2,482,157 cases from the FY 2013 MedPAR file, which mapped to 567 MS–DRGs. The top five MS–DRGs containing cases that may be eligible for AVYCAZ are: MS– DRG 689 (Kidney and Urinary Tract Infections with MCC); MS–DRG 690 (Kidney and Urinary Tract Infections E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 24436 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules without MCC); 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 Without MCC); and MS–DRG 945 (Rehabilitation with CC/MCC). The top five MS–DRGs represent approximately 30 percent of the cases identified (731,560 cases out of 2,482,157 total cases), reported using 1 of the 35 respective ICD–9–CM diagnosis codes. To demonstrate that AVYCAZ met the cost criterion, the applicant provided multiple analyses for both cUTI and cIAI cases using 100 percent or 80 percent of all of the cases, as well as analyses of subset cases treated with low-cost generic drugs and high-cost brand named drugs administered for a length of 5 and 8 days. The applicant began its analysis by searching the FY 2013 MedPAR file and identifying 2,183,467 cases representing patients diagnosed with a cUTI across 544 MS–DRGs, and 298,690 cases representing patients diagnosed with a cIAI across 385 MS–DRGs. This resulted in the identification of 1,146,971 cases representing patients diagnosed with a cUTI across 205 MS–DRGs, and 39,080 cases representing patients diagnosed with a cIAI across 32 MS–DRGs. After searching the FY 2013 IPPS Impact File, the applicant focused its analysis on 1,067,111 cases representing patients diagnosed with a cUTI across 193 MS– DRGs and 36,181 cases representing patients diagnosed with a cIAI across 31 MS–DRGs. The applicant further modified a portion of its analysis to focus on 1,067,072 cases representing patients diagnosed with a cUTI across 192 MS–DRGs in accordance with the thresholds obtained from Table 10 of the FY 2015 IPPS/LTCH PPS final rule. Based on these data, for this analysis, the applicant used 100 percent of all of the cases representing patients diagnosed with a cUTI (1,067,072 cases) across 192 MS–DRGs. The applicant determined an average case-weighted standardized charge per case of $42,736. The applicant then excluded the charges for the specific technology used from the average case-weighted standardized charge per case. To continue its analysis, the applicant used two different variables to exclude the charges for specific technologies used, that is, the charges for low-cost generic drugs and the charges for high-cost brand named drugs administered for a length of 5 and 8 treatment days. The applicant explained that, at a minimum, it is recommended that antibiotics be administered for at least 5 days to prevent the development of antibiotic- VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 resistant bacteria.8 The applicant noted that, according to the Arlington Medical Resources (AMR),9 the average length of therapy for patients diagnosed with an UTI and/or an IAI who were successfully treated for less than 5 days only represents 0.28 percent of all cases representing these types of conditions. Therefore, a 5-day treatment regimen was selected as a basis to represent the most conservative approach. In addition, the AMR’s database indicated that the average length of therapy for patients diagnosed with an UTI who were successfully treated was 8.3 days and, therefore, the applicant selected a 8-day treatment regimen as a basis to represent a more liberal approach. The applicant also used data from the AMR to determine which drugs are the most commonly purchased injectable antibiotics. The applicant estimated a total charge of $441.75 for low-cost generic drugs and charges related to the infusion of these drugs for a 5-day treatment regimen, and $706.80 for a 8day treatment regimen. The applicant estimated a total charge of $1,535.95 for high-cost brand named drugs and charges related to the infusion of these drugs for a 5-day treatment regimen, and $2,397.58 for an 8-day treatment regimen. The applicant then standardized and inflated the charges using a factor of 7.13 percent using the Medicare Economic Index from the latest CMS Market Basket Data file.10 The applicant then added the charges for AVYCAZ and the infusion of AVYCAZ based on a 5-day treatment regimen and an 8-day treatment regimen. Depending on the amount of charges excluded for the use of specific drugs and the charges related to the infusion of these drugs, the applicant determined a final inflated average caseweighted standardized charge per case that ranged from $42,469 to $46,842. 8 Antibiotics. Merck Manual. Available at: https://www.merckmanuals.com/home/infections/ antibiotics.html. 9 The AMR database is a U.S. hospital inpatient database that provides updated information every 6 months. AMR gathers data from approximately 300 hospitals per year, providing information from approximately 22,000 patient records. Pharmacists from these hospitals fill out an inpatient profile form by verbatim transcription of information from patient charts, such as patient demographics, surgery codes, antibiotics used, dosage, start and end dates for each antibiotic used, and specialty information. These inpatient profile forms are then submitted to AMR in paper format. Data from this sampling of hospitals is projected to the universe of US hospitals. Available at: https://www.amrdata.com/. 10 Centers for Medicare and Medicaid Services. Market Basket Data. Available at: https:// www.cms.gov/Research-Statistics-Data-andSystems/Statistics-Trends-and-Reports/ MedicareProgramRatesStats/ MarketBasketData.html. PO 00000 Frm 00114 Fmt 4701 Sfmt 4702 Using the FY 2015 IPPS Table 10, the average case-weighted threshold amount for all of the MS–DRGs used is $40,303 (all calculations above were performed using unrounded numbers). Because the final inflated average case-weighted standardized charge per case under all of these scenarios exceeds the average case-weighted threshold amount, the applicant maintained that AVYCAZ meets the cost criterion under this analysis. The applicant conducted another analysis using the 80-percent variable for 846,897 cases representing patients diagnosed with a cUTI and/or a cIAI based on 3 of the ICD–9–CM diagnosis codes identified across 15 MS–DRGs. Depending on the amount of the charges excluded for the cost of the specific drugs and the charges related to the infusion of these drugs, the applicant determined a final inflated average caseweighted standardized charge per case that ranged from $37,086 to $41,459. Using the FY 2015 IPPS Table 10, the average case-weighted threshold amount across the 15 MS–DRGs used is $36,411 (all calculations above were performed using unrounded numbers). Because the final inflated average case-weighted standardized charge per case under all of these scenarios exceeds the average case-weighted threshold amount, the applicant maintained that AVYCAZ also meets the cost criterion under this analysis. The applicant conducted another analysis using 100 percent of all of the cases representing patients who have been diagnosed with a cIAI (36,181 cases) across 31 MS–DRGs, and determined an average case-weighted standardized charge per case of $51,436.98. The applicant then excluded the charges for the specific technology used from the average caseweighted standardized charge per case. To continue its analysis, the applicant used two different variables to exclude the charges for the specific technologies used; that is, the charges for low-cost generic drugs and the charges for highcost brand named drugs administered for a length of 5 and 8 treatment days. The applicant explained that, at a minimum, it is recommended that antibiotics be administered for at least 5 days to prevent the development of antibiotic-resistant bacteria. The applicant also noted that, according to the AMR, the average length of therapy for patients diagnosed with an UTI and/ or an IAI that was successfully treated in less than 5 days only represents 0.28 percent of all cases representing these types of conditions. Therefore, a 5-day treatment regimen was selected as a basis to represent the most conservative E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules approach. In addition, the AMR’s database indicated that the length of therapy for patients diagnosed with an IAI was 11.2 days and, therefore, the applicant selected a 8-day regimen as a basis to represent a more liberal approach. The applicant then added charges for AVYCAZ and the infusion of AVYCAZ based on a 5-day or 8-day treatment regimen. Depending on the amount of the charges excluded for the specific drugs used and the charges related to the infusion of these drugs, the applicant determined a final inflated average case-weighted standardized charge per case that ranged from $58,565 to $62,937. Using the FY 2015 IPPS Table 10 thresholds, the average case-weighted threshold amount across all of the MS–DRGs used is $51,436 (all calculations above were performed using unrounded numbers). Because the final inflated average case-weighted standardized charge per case under all of these scenarios exceeds the average case-weighted threshold amount, the applicant maintained that AVYCAZ also meets the cost criterion under this analysis. The applicant conducted another analysis using the 80-percent variable for 28,483 cases representing patients diagnosed with a cIAI based on 5 of the ICD–9–CM diagnosis codes identified across 4 MS–DRGs. Depending on the amount of the charges excluded for the specific drugs used and the charges related to the infusion of these drugs, the applicant determined a final inflated average case-weighted standardized charge per case that ranged from $50,435.54 to $54,809.30. Using the FY 2015 IPPS Table 10 thresholds, the average case-weighted threshold amount across all of the MS–DRGs used is $47,186 (all calculations above were performed using unrounded numbers). Because the final inflated average caseweighted standardized charge per case under all of these scenarios exceeds the average case-weighted threshold amount, the applicant maintained that AVYCAZ also meets the cost criterion under this analysis. We are concerned that the applicant did not use the inflation factor of 10.4427 when calculating the average case-weighted standardized charge per case, which is the same inflation factor used by CMS to update the FY 2015 outlier threshold, and did not offer a rationale for its alternative inflation factor. We are inviting public comments on whether AVYCAZ meets the cost criterion, specifically with regard to our concerns. The applicant maintained that AVYCAZ represents a substantial clinical improvement in the available VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 treatment options for patients diagnosed with a cIAI and/or a cUTI, including cUTIs and cIAIs that are known or suspected to be caused by extendedspectrum b-lactamase (ESBL)-producing Gram-negative pathogens, carbapenemresistant Enterobacteriaceae (CRE), and multidrug-resistant (MDR) Pseudomonas aeruginosa. According to the applicant, existing treatment options for these types of conditions are very limited and pose toxicity risks. The applicant stated that antibiotic-resistant infections are a serious problem for health care providers and patients. Among the bacteria resistant to all or nearly all of the antibiotics available today, CRE has developed rapidly and continues to proliferate. The applicant noted that, as of 2014, 49 States have reported confirmed CRE infections, an increase from 42 States that reported and confirmed CRE infections in 2013.11,12 Almost half of hospital patients who get bloodstream infections from CRE bacteria die from the infection.13 The applicant further noted that, over the last 20 years, Gramnegative bacteria have evolved in defense against recently approved broad-spectrum b-lactam agents (for example, +-lactam +-lactamase inhibitors [BL–BLIs] and carbapenems) by producing a multitude of ‘‘new’’ blactamases—including extendedspectrum b-lactamases (ESBLs) and carbapenemases that can confer resistance to these front-line agents. Because of the technology’s inhibiting activity against these pathogens, the applicant maintained that AVYCAZ may provide a safer and more effective treatment option for patients diagnosed with cIAIs and cUTIs caused by these antibiotic-resistant organisms. The applicant further noted that there are serious side effects associated with the current treatment options and regimens, such as Polymyxins, Colistin, Aminoglycosides, Carbapenems, and Tigecycline,14 including resistance to nephrotoxicity. 11 Tracking CRE—Carbapenempase producing CRE in the US. CDC HAI Web site. Available at: https://www.cdc.gov/hai/organisms/cre/ TrackingCRE.html. 12 Making health care safer—Stop infections from lethal CRE germs now. CDC Vital Signs 2013. Available at: https://www.cdc.gov/vitalsigns/pdf/ 2013-03-vitalsigns.pdf. 13 Antobiotics. Merck Manual. Available at: https://www.merckmanuals.com/home/infections/ antibiotics.html. 14 Bader M, Hawboldt J, Brooks A. Management of complicated urinary tract infections in the era of antimicrobial resistance. Postgraduate Medicine.2010; 122(6):7–15. Rishi H, Dhillon P, Clark C. ESBLs: a clear and present danger? Critical Care Research and Practice, 2012; Article ID 625170. PO 00000 Frm 00115 Fmt 4701 Sfmt 4702 24437 The applicant provided data from the REPRISE study, which compared AVYCAZ and Carbapenem, also used as a treatment option for patients diagnosed with cIAIs and cUTIs. This study was specifically designed to demonstrate the inhibiting activity of Avibactam to restore the clinical and microbiological efficacy of Ceftazidime verses Ceftazidime-resistant, blactamase-producing Gram-negative bacteria. According to the applicant, in the pooled cIAI and cUTI studies,15 the by-pathogen microbiological response rate was assessed using the test of cure (TOC) as a measuring tool. TOC refers to the reculturing of a site of initial infection to determine whether the patient is cured.16 TOC was the same or numerically higher for AVYCAZ versus the comparator for almost all pathogens isolated for the treatment of ceftazidimenonsusceptible (CAZ–NS). We are concerned that the results of this study do not show that AVYCAZ has more favorable clinical or microbiological responses when compared to existing technologies. According to § 412.87(b)(1) of our regulations, in order to satisfy the substantial clinical improvement criterion, the applicant must demonstrate that the technology represents an advance that substantially improves, relative to technologies previously available, the diagnosis or treatment of Medicare beneficiaries. The applicant reported that the INFORM study 17 is one of the ongoing in vitro studies of AVYCAZ. According to the results of this study, Avibactam extends the activity of Ceftazidime and provides a broad spectrum of activity compared to currently available therapies. In addition, AVYCAZ demonstrated activity against two of the four areas of need as stated by the CDC, and potentially demonstrated activity against a third. The two areas of need that demonstrated favorable microbiological response were carbapenem-resistant Enterobacteriaceae (CRE) and extended-spectrum blactamase (ESBL). We are concerned that in vitro studies may not necessarily correlate with clinical results. The applicant also provided conclusions and data from one of the Phase II clinical trials conducted for patients diagnosed with cIAIs and cUTIs, respectively. The applicant reported that the patients diagnosed Jacoby GA, Munoz-Price LS. The New bLactamases.N Engl J Med 2005; 352:380–391. 15 Pooled data includes subset of patients from Phase II trials and interim data from the Phase III REPRISE trial. 16 https://medicaldictionary.thefreedictionary.com/test+of+cure. 17 Data on File. Actavis 2014. E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 24438 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules with cIAIs were randomized to either AVYCAZ with Metronidazole versus the control drug Meropenem. The clinical cure rates at TOC were 82.4 percent for the AVYCAZ + Metronidazole group, and 88.8 percent for the Meropenem group for patients diagnosed with cIAIs. For patients diagnosed with cUTIs, the applicant reported that they were randomized to either AVYCAZ versus Imipenem. The clinical cure rates at TOC were 80.4 percent versus 73.5 percent for the AVYCAZ group versus the Imipenem group for patients diagnosed with cUTIs. The applicant also provided data from the RECLAIM–1 and RECLAIM–2 trials. The applicant reported that these trials evaluated the safety and efficacy of AVYCAZ versus the control drug used to treat patients hospitalized for cIAIs. According to the applicant, AVYCAZ technology met the objective of statistical noninferiority when compared to the control drug. However, the applicant asserted, in a subgroup of patients diagnosed with moderate renal impairment at baseline (MRIB [defined as an estimated creatinine clearance (ClCr) of >30 mL/min and ≤50 mL/ min]), AVYCAZ combined with Metronidazole had lower clinical cure rates when compared to the control group. In addition to the clinical response rate findings, although the number of deaths was minimal, they were numerically higher for patients diagnosed with MRIB who were treated with AVYCAZ in combination with Metronidazole when compared to patients treated with Meropenem. The applicant acknowledged that this result was not more favorable and reviewed the individual cases of failure or indeterminate (including all deaths) for the patients diagnosed with MRIB, and identified no predominant reason for the treatment difference observed in the subgroup analysis. However, the applicant maintained that AVYCAZ represents a substantial clinical improvement because of the adverse effects of other currently available treatment options such as nephrotoxicity. We are concerned that the findings cited by the applicant lack data regarding the adverse effects of nephrotoxicity because of treatment using other currently available treatment options. The applicant stated that, in the Phase II trials, the Medicare-eligible population represented 9.2 percent of the total population of patients diagnosed with cIAIs, and 14.8 percent of the total population of patients diagnosed with cUTIs. We are concerned that a cohort that would reflect a Medicare population was not VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 analyzed or predefined as a subgroup in the trials to better understand and quantify the substantial clinical improvement of AVYCAZ. Furthermore, we are unsure whether a possibility of a favorable safety and tolerability profile for AVYCAZ relative to other currently available treatment options for patients diagnosed with cUTIs and cIAIs implies a substantial clinical improvement. The applicant maintained that AVYCAZ represents a substantial clinical improvement over treatment options currently available to Medicare beneficiaries. We do not believe that the applicant has substantiated this assertion. With regard to the data indicating the safety of the technology, we are concerned that the results for the trials could be interpreted to suggest that use of the technology may lead to increased mortality. We note that the composition of the treatment and control groups may make it difficult to isolate the degree to which AVYCAZ affects safety and health care outcomes because the patients in the treatment group were also treated with another drug administered in combination with AVYCAZ. Moreover, we are concerned that the median age of the participants enrolled in the studies of AVYCAZ was between 40 and 50 years. We believe that it would be indicative to use a subgroup that actually represents the eligible Medicare population (that is, patients who are 65 years of age or older, blind, disabled, or diagnosed with end-stage renal disease). The applicant stated that AVYCAZ had greater efficacy and safety measures for patients who have limited or no other available treatment options. However, we are concerned that the patient population enrolled in the applicant’s trials were not eligible Medicare beneficiaries, nor was it definitive that these participants had limited or no other available treatment options. We are inviting public comments on whether AVYCAZ meets the substantial clinical improvement criterion, specifically with regard to our stated concerns. We did not receive any written public comments in response to the New Technology Town Hall meeting regarding the application of AVYCAZ for new technology add-on payments. d. DIAMONDBACK 360® Coronary Orbital Atherectomy System Cardiovascular Systems, Inc. submitted an application for new technology add-on payments for the DIAMONDBACK 360® Coronary Orbital Atherectomy System (OAS) (DIAMONDBACK® Coronary OAS) for FY 2016. The DIAMONDBACK® Coronary OAS is a percutaneous orbital PO 00000 Frm 00116 Fmt 4701 Sfmt 4702 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 DIAMONDBACK® Coronary OAS are: (1) The DIAMONBACK 360® 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 360® 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 360® OAD and the VIPERWIRE. The Orbital Atherectomy System Pump provides the saline pumping mechanism and power to the DIAMONBACK 360® OAD. All DIAMONDBACK® Coronary OAS devices are single use and provide sterile application, except for the pump. With respect to the newness criterion, the DIAMONDBACK® 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 this proposed rule, effective October 1, 2015 (FY 2016), the ICD–10 coding system will be implemented. We note that the applicant submitted a request for a unique ICD–10–PCS code that was presented at the March 18, 2015 ICD–10 Coordination and Maintenance Committee meeting. If approved, the code(s) will be effective on October 1, 2015 (FY 2016). More information on this request can be found on the CMS Web site at: https:// www.cms.gov/Medicare/Coding/ ICD9ProviderDiagnosticCodes/ICD-9CM-C-and-M-Meeting-Materials.html. According to the applicant, the DIAMONDBACK® 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 DIAMONDBACK® 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 E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules DIAMONDBACK® Coronary OAS meets the newness criterion. We are concerned that, in addition to patients who have been diagnosed with severely calcified coronary artery lesions, the applicant also indicated that the DIAMONDBACK® 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, 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 are concerned that the applicant did not include with their application data to show the effectiveness of the orbital mechanism of the DIAMONDBACK® 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 cannot determine if the device’s mechanism of action is unique among atherectomy devices as the applicant claimed. With respect to the second criterion, the applicant determined that coronary atherectomy cases for which the DIAMONDBACK® Coronary OAS technology would be appropriate are assigned to MS–DRG 246 (Percutaneous VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 Cardiovascular Procedure with DrugEluting Stent with MCC or 4+ Vessels/ Stents); MS–DRG 247 (Percutaneous Cardiovascular Procedure with DrugEluting 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 are concerned that potential cases involving the DIAMONDBACK® 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, the applicant maintained that the DIAMONDBACK® 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 DIAMONDBACK® 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, we are concerned 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 are not sure if patients with less than severe coronary calcification could be appropriately treated using the DIAMONDBACK® Coronary OAS or other atherectomy devices currently available on the U.S. market in order to determine if the DIAMONDBACK® Coronary OAS treats a different patient population as the applicant claimed. We are inviting public comments on if, and how, the DIAMONDBACK® Coronary OAS meets the newness criterion. In our subsequent discussion of the cost and substantial clinical improvement criteria, we limit our analysis of the new technology device to a patient population who has severely calcified coronary lesions for which the other devices are contraindicated for use. PO 00000 Frm 00117 Fmt 4701 Sfmt 4702 24439 With respect to the cost criterion, the applicant determined that cases representing patients who have been treated with transluminal coronary atherectomy for which the DIAMONDBACK® 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 DIAMONDBACK® 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 DIAMONDBACK® 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 DIAMONDBACK® Coronary OAS device exceeds the average caseweighted threshold amounts for MS– DRGs 246 through 251 in Table 10 by between approximately $6,000 to $15,000, depending on the results determined by using the combination of E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 24440 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 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 DIAMONDBACK® 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 DIAMONDBACK® 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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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 DIAMONDBACK® 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 DIAMONDBACK® Coronary OAS meets the cost criterion. We question some of the assumptions underlying the four areas of uncertainty that were the basis for the applicant’s sensitivity analyses. 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 are concerned 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 are inviting public comments on if, and how, the DIAMONDBACK® Coronary OAS meets the cost criterion. The applicant maintained that the DIAMONDBACK® 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 DIAMONDBACK® Coronary OAS device significantly improves clinical PO 00000 Frm 00118 Fmt 4701 Sfmt 4702 outcomes for this patient population when compared to currently available treatment options, including reduced mortality, a reduced rate of devicerelated 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 DIAMONDBACK® 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 DIAMONDBACK® Coronary OAS was used to prepare patients who had severely calcified coronary lesions for stent placement. According to the applicant, the DIAMONDBACK® 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 <50 percent post-stent without in-hospital MACE) was 88.9 percent, compared with the performance goal of 82 percent. The applicant stated that, during the trial, stent delivery after use of the DIAMONDBACK® Coronary OAS occurred successfully in 97.7 percent of cases with <50 percent residual stenosis in 98.6 percent of the patients in the study. The applicant further stated that low rates of in-hospital Q-wave MI, cardiac death, and target vessel revascularization also were reported. The applicant believed that the results of its ORBIT II study met both the primary safety and efficacy endpoints by significant margins and not only E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules tkelley on DSK3SPTVN1PROD with PROPOSALS2 helped to facilitate stent delivery, but also improved both acute care and 30day clinical outcomes compared to historical controls. The applicant also compared the results of its ORBIT II study with historical study data that measured the performance of other coronary atherectomy devices used in the treatment of patients who have moderate to severely calcified coronary lesions. According to the applicant, the death and revascularization rates reported in the ORBIT II study were much lower than those rates reported in the literature for patients who had severely calcified coronary lesions. For example, inpatient cardiac death rates were reported on one reported study in the literature (Mosseri, et al.) as 1.6 percent and in another reported study (Abdel-Wahab, et al.) as 1.7 percent, while another study report (Clavijo, et al.) reported death at 30 days as 2.6 percent and 1.5 percent for RA + DES and DES, respectively. 18 19 20 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,21 whereas the study report by Clavijo, et al. reported a 1.3 percent 30-day TLR rate for the RA + DES group.22 In contrast, the applicant 18 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. 19 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. 20 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. 21 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. 22 Clavijo LC, Steinberg DH, Torguson R, et al. Sirolimus-eluting stents and calcified coronary lesions: clinical outcomes of patients treated with VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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.23 24 Further, the 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. We are concerned that the ORBIT II study conducted by the applicant lacked a control arm. The applicant asserted 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 and without rotational atherectomy. Catheter Cardiovasc Interv Off J Soc Card Angiogr Interv. 2006;68(6):873–878. 23 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. 24 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. PO 00000 Frm 00119 Fmt 4701 Sfmt 4702 24441 continue to be concerned that meaningful conclusions cannot be drawn from a study that did not include a comparator group. Moreover, we question 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 are inviting public comments on if, and how, DIAMONDBACK® Coronary OAS meets the substantial clinical improvement criterion. e. CRESEMBA® (Isavuconazonium) Astellas Pharma US, Inc. (Astellas) submitted an application for new technology add-on payments for CRESEMBA® (isavuconazonium) for FY 2016. CRESEMBA® 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). CRESEMBA® received FDA approval on March 6, 2015 and anticipates that the market availability on the U.S. market will start by the second week of April 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 isavuconazonium is administered at 200 mg of isavuconazole. The oral formulation of isavuconazonium is administered at 100 mg of isavuconazole. 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 13.4 days. As stated in section II.G.1.a. of the preamble of this proposed rule, effective October 1, 2015 (FY 2016), the ICD–10 coding system will be implemented. We note that the applicant submitted a request for unique ICD–10–PCS codes that was presented at the March 18, 2015 ICD–10 Coordination and Maintenance Committee meeting. If approved, the codes will be effective on October 1, 2015 (FY 2016). More information on this request can be found on the CMS Web site at: https:// www.cms.gov/Medicare/Coding/ ICD9ProviderDiagnosticCodes/ICD-9CM-C-and-M-Meeting-Materials.html. E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 24442 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules If the technology were to be approved for a new technology add-on payment, we believe its newness period would begin on March 6, 2015, the date of FDA approval. At this time, the applicant has not submitted any specific information to establish that the technology was not available on the U.S. market as of the FDA approval date or to describe the reasons for a delay of availability until the second week of April 2015. The applicant maintained that CRESEMBA® meets the newness criterion. CRESEMBA® is part of the category of drugs known as azole antifungal drugs that inhibit the enzyme lanosterol 14 ademethylase. 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 antifungal drugs also used for the treatment of these patients include voriconazole, posaconazole, and itroconazole. The CDC Web site at https://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 first-line of therapy and the only FDA-approved 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-Dglucan 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 (https://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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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 sometimes challenging to clinically distinguish the type of antifungal infection a patient may be experiencing. Therefore, the typical treatment of patients exhibiting symptoms of 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. We are concerned that CRESEMBA® may be substantially similar to other currently approved antifungal drugs. We refer readers to the FY 2010 IPPS/RY 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. 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, we believe that CRESEMBA® has a similar mechanism of action as the other groups of antifungal drugs available for the treatment of patients 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, and amphotericin B is a polyene antifungal commonly used to treat patients diagnosed with mucormycosis. The applicant maintained that the availability of the drug in an oral formulation constitutes a different mechanism of action. We disagree 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 CRESEMBA® is part of the category of PO 00000 Frm 00120 Fmt 4701 Sfmt 4702 drugs currently available known as azole antifungal drugs that inhibit the enzyme lanosterol 14 a-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 believe that the use of CRESEMBA® 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 CRESEMBA® would not impact the MS–DRG assignment of a particular case. Furthermore, 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, CRESEMBA® is used in conjugation with other treatments, and this is reflected in its analysis for the new technology cost criterion. We are concerned that this technology is administered with the other currently available treatments, and therefore cannot be considered an alternative treatment option. Therefore, we believe that CRESEMBA® may be considered substantially similar to other available treatments and cannot be considered ‘‘new’’ for purposes of new technology add-on payments. We are inviting public comments on if, and how, CRESEMBA® meets the newness criterion and our concerns regarding how it is substantially similar to other treatments for serious fungal infections. 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 E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 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 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 caseweighted standardized charge per case of $151,450. Because this average caseweighted standardized charge per case exceeded the average case-weighted threshold amount from the FY 2015 Table 10, the applicant maintained that CRESEMBA® 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 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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 caseweighted standardized charge per case exceeded the average case-weighted threshold amount in the FY 2015 Table 10, the applicant maintained that CRESEMBA® meets the cost criterion using this second analysis. We are 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 CRESEMBA® 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 note 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 CRESEMBA® would be dependent upon the simultaneous and combined use of the other existing therapies to achieve successful treatment. Therefore, we are concerned about the possibility of drug toxicity, poly pharmacy, and drug-to-drug interactions, especially among the Medicare population. We are seeking public comment on whether CRESEMBA® meets the cost criterion, specifically with regard to our concerns regarding the applicant’s analyses and methodology. With regard to substantial clinical improvement, the applicant believed that CRESEMBA® represents a substantial clinical improvement over existing therapies for patients diagnosed with invasive aspergillus 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.25 26 The applicant provided 25 Lin SJ, Schranz J, Teutsch SM.: Aspergillosis case-fatality rate: systematic review of the literature. ClinInfect Dis. 2001;32:358-66. PO 00000 Frm 00121 Fmt 4701 Sfmt 4702 24443 information regarding its SECURE study, where the primary endpoint of all-cause mortality through day 42 showed that CRESEMBA® demonstrated noninferiority to voriconazole. The primary endpoint of all-cause mortality through day 42 in the intent-to-treat 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 CRESEMBA® 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 treatmentemergent adverse reactions occurred in 96 percent and 99 percent of patients receiving the CRESEMBA® and voriconazole, respectively. We are concerned that the adverse reactions associated with the use of CRESEMBA® and voriconazole appear to be similar. We also are 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 FDA-approved 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. With regard to improved efficacy, the applicant made several assertions. The applicant maintained that the use of CRESEMBA® 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.27 However, we are concerned that the results of the study reported by the applicant did not reflect this. Specifically, the applicant believed that CRESEMBA® has positive activity against a broad range of fungi, including those resistant to other agents, thereby potentially decreasing subsequent therapeutic interventions.28 However, 26 Greenberg RN, Scott LJ, Vaughn HH, Ribes JA.: Zygomycosis (mucormycosis): emerging clinical importance and new treatments. Curr Opin Infect Dis. 2004;17:517-25. 27 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. 28 Gonzalez GM.: Med Mycol. 2009 Feb;47(1):71– ´ 6. doi:10.1080/13693780802562969. Epub 2008 Dec E:\FR\FM\30APP2.SGM Continued 30APP2 24444 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules tkelley on DSK3SPTVN1PROD with PROPOSALS2 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, CRESEMBA® is used to treat immunocomprised patients who are severely ill. The applicant also stated that CRESEMBA® 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.29 The applicant maintained that the use of CRESEMBA® decreases the number of future hospitalizations or physician visits. We are concerned 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 isavuconazole 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 isavuconazole arm (9 days) compared with patients treated with voriconazole in the control arm. According to the applicant, patients treated with isavuconazonale 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.30 With regard to improved safety and a more favorable pharmacokinetic profile, the applicant made several assertions. 18. PMID: 19101837 [PubMed—indexed for MEDLINE] 29 Kontoyiannis DP, Lewis RE.: How I treat mucormycosis. Blood. 2011;118:1216-24. 30 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. VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 The applicant asserted that CRESEMBA® 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. In addition, the applicant asserted that CRESEMBA® 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 CRESEMBA® can be safely used in treating patients with renal impairment, whereas currently available treatments can harm the kidneys.31 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. We are concerned that these results were not communicated in the resulting data provided by the applicant that were obtained from the trials. We also are concerned that the applicant did not provide a rationale for its assertion that the use of CRESEMBA® 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-todrug interactions and nephrotoxicity. 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. We are 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 31 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. PO 00000 Frm 00122 Fmt 4701 Sfmt 4702 inpatients are often severely ill and may not be able to tolerate any food or medications orally. We are seeking public comments on whether or not CRESEMBA® meets the substantial clinical improvement criterion, specifically taking into consideration our concerns described above. We did not receive any written public comments in response to the New Technology Town Hall Meeting regarding the application for CRESEMBA® for new technology addon payments. f. Idarucizumab Boehringer Ingelheim Pharmaceuticals, Inc. submitted an application for new technology add-on payments for Idarucizumab, a product developed as an antidote to reverse the effects of PRADAXA® (Dabigatran), which is also manufactured by Boehringer Ingelheim Pharmaceuticals, Inc. Dabigatran is an oral direct thrombin inhibitor currently indicated to: (1) Reduce the risk of stroke and systemic embolism in patients who have been diagnosed with nonvalvular atrial fibrillation (NVAF); (2) treat deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been administered a parenteral anticoagulant for 5 to 10 days; and (3) reduce the risk of recurrence of DVT and PE in patients who have been previously diagnosed with NVAF. Currently, unlike the anticoagulant Warfarin, there is no specific way to reverse the anticoagulant effect of Dabigatran in the event of a major bleeding episode. Idarucizumab is a humanized fragment antigen binding (Fab) molecule, which specifically binds to Dabigatran to deactivate the anticoagulant effect, thereby allowing thrombin to act in blood clot formation. The applicant stated that Idarucizumab represents a new pharmacologic approach to neutralizing the specific anticoagulant effect of Dabigatran in emergency situations. If FDA approval is granted, Idarucizumab would be the only FDA-approved therapy available to neutralize the anticoagulant effect of Dabigatran. The current approach for the management of the anticoagulant effect of Dabigatran prior to an invasive procedure is to withhold administration of Dabigatran, when possible, for a certain duration of time prior to the procedure to allow sufficient time for the patient’s kidneys to flush out the medication. The duration of time needed to flush out the medication prior to the surgical procedure is based on the patient’s kidney function. According to the applicant, if surgery cannot be E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules delayed to allow the kidneys the necessary time to flush out the traces of Dabigatran, there is an increased risk of bleeding. Based on the proposed FDA indication for Idarucuzimab, the product can be used in the treatment of patients who have been diagnosed with NVAF and administered Dabigatran to reverse life-threatening bleeding events, or who require emergency surgery or medical procedures and rapid reversal of the anticoagulant effects of Dabigatran is necessary and desired. As of this date, Idarucuzimab has not received approval from the FDA. However, in June 2014, the FDA granted Idarucizumab Breakthrough Therapy Designation. In addition, the applicant plans to seek Fast Track Designation from the FDA. Currently, there are no specific ICD–9–CM or ICD–10–PCS procedure codes that describe the use of Idarucizumab. As stated above, effective October 1, 2015 (FY 2016), the ICD–10 coding system will be implemented. The applicant submitted a request for unique ICD–10–PCS codes that was presented at the March 18, 2015 ICD–10 Coordination and Maintenance Committee meeting. If approved, the codes will be effective on October 1, 2015 (FY 2016). More information on this request can be found on the CMS Web site at: https://www.cms.gov/ Medicare/Coding/ ICD9ProviderDiagnosticCodes/ICD-9CM-C-and-M-Meeting-Materials.html. We are inviting public comments on whether Idarucizumab meets the newness criterion. With regard to the cost criterion, the applicant conducted four analyses. The applicant began by researching the FY 2013 MedPAR file for cases that may be eligible for Idarucizumab using a combination of ICD–9–CM diagnosis and procedure codes. Specifically, the applicant searched the database for cases reporting anticoagulant therapy diagnosis codes E934.2 (Agents primarily affecting blood constituents, anticoagulants) or V58.61 (Long-term (current) use of anticoagulants) in combination with either current standard of care procedure codes 99.03 (Other transfusion of whole blood), 99.04 (Transfusion of packed cells), 99.05 (Transfusion of platelets), 99.06 (Transfusion of coagulation factors), 99.07 (Transfusion of other serum), or 39.95 (Hemodialysis), and Dabigatran indication diagnosis codes 427.31 (Atrial fibrillation), 453.40 (Acute venous embolism and thrombosis of unspecified deep vessels of lower extremity), 453.41 (Acute venous embolism and thrombosis of deep vessels of proximal lower extremity), VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 453.42 (Acute venous embolism and thrombosis of deep vessels of distal lower extremity), 453.50 (Chronic venous embolism and thrombosis of unspecified deep vessels of lower extremity), 453.51 (Chronic venous embolism and thrombosis of deep vessels of proximal lower extremity), 453.52 (Chronic venous embolism and thrombosis of deep vessels of distal lower extremity), 415.11 (Iatrogenic pulmonary embolism and infarction), 415.12 (Septic pulmonary embolism), 415.13 (Saddle embolus of pulmonary artery), 415.19 (Other pulmonary embolism and infarction), 416.2 (Chronic pulmonary embolism), V12.51 (Personal history of venous thrombosis and embolism), or V12.55 (Personal history of pulmonary embolism). To further target potential cases that may be eligible for Idarucizumab, the applicant also excluded specific cases based on Dabigatran contraindications, including all cases representing patients who have been diagnosed with chronic kidney disease (CKD) stage V (diagnosis code 585.5), end-stage renal disease (diagnosis code 585.6), prosthetic heart valves (diagnosis code V43.3), and cases representing patients who have been diagnosed with both CKD stage IV (diagnosis code 585.4) and either DVT or PE (using the same ICD–9–CM diagnosis codes listed above). As a result, the applicant identified 103,752 cases that mapped to 694 MS–DRGs. The applicant standardized the charges and computed an average case-weighted standardized charge per case of $57,611. The applicant then identified hospital charges potentially associated with the current treatments to reverse anticoagulation, specifically charges associated with pharmacy services, dialysis services, and laboratory services for blood work. Due to limitations associated with the claims data, the applicant was unable to determine the specific drugs used to reverse anticoagulation and if these cases represented patients who required laboratory services for blood work or dialysis services unrelated to the reversal of anticoagulation. Therefore, the applicant subtracted 40 percent of the charges related to these three categories from the standardized charge per case, based on the estimation that the full amount of charges associated with these services would not be incurred by hospitals if Idarucizumab is approved and available for use in the treatment of patients who have been diagnosed with NVAF and administered Dabigatran during treatment. The applicant then inflated the standardized charge per case by 10.4227 percent, the same inflation factor used by CMS to PO 00000 Frm 00123 Fmt 4701 Sfmt 4702 24445 update the FY 2015 outlier threshold (79 FR 50379). This resulted in an inflated average case-weighted standardized charge per case of $59,582. Using the FY 2015 IPPS Table 10 thresholds, the average case-weighted threshold amount across all 694 MS– DRGs is $54,850 (all calculations above were performed using unrounded numbers). Because the inflated average case-weighted standardized charge per case exceeds the average case-weighted threshold amount, the applicant maintained that the technology meets the cost criterion under this analysis. The applicant also performed a similar analysis by using the same data from the FY 2013 MedPAR file and subtracting 60 percent of the charges associated with pharmacy services, dialysis services, and laboratory services for blood work. This resulted in an inflated average case-weighted standardized charge per case of $57,560. Using the FY 2015 IPPS Table 10 thresholds, the average case-weighted threshold amount across all 694 MS– DRGs is $54,850 (all calculations above were performed using unrounded numbers). Because the inflated average case-weighted standardized charge per case for the applicable MS–DRGs exceeds the average case-weighted threshold amount, the applicant maintained that the technology also meets the cost criterion under this analysis. Further, the applicant conducted two additional analyses using the same data from the FY 2013 MedPAR file and variables used in the previous analyses. However, instead of using potentially eligible cases that mapped to 100 percent of the 694 MS–DRGs identified, the applicant used potentially eligible cases that mapped to the top 75 percent of the 694 MS–DRGs identified. By applying this limitation, the applicant identified 77,667 cases that mapped to 92 MS–DRGs. Under the analysis’ variable that subtracted 40 percent of the charges associated with the current treatments to reverse anticoagulation, the applicant computed an inflated average case-weighted standardized charge per case of $56,627. Under the analysis’ variable that subtracted 60 percent of the charges associated with the current treatments to reverse anticoagulation, the applicant computed an inflated average case-weighted standardized charge per case of $54,677. Using the FY 2015 IPPS Table 10 thresholds, the average case-weighted threshold amount across all 92 MS– DRGs using both scenarios is $53,008 (all calculations above were performed using unrounded numbers). Because the inflated average case-weighted E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 24446 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules standardized charge per case exceeds the average case-weighted threshold amount, the applicant maintained that the technology also meets the cost criterion under these variant analyses. The applicant noted that the inflated average case-weighted standardized charge per case computed using all four scenarios did not include any charges for Idarucizumab. Therefore, the applicant maintained that the technology would also meet the cost criterion if charges for Idarucizumab were included because the inflated average case-weighted standardized charge per case would increase and further exceed the average caseweighted threshold amount using the variables of all four analyses. We are inviting public comments regarding the applicant’s analyses with respect to the cost criterion. With regard to substantial clinical improvement, according to the applicant, there are currently no specific FDA-approved antidotes to reverse the anticoagulant effects of Dabigatran. Management of the treatment of patients who have been diagnosed with NVAF and administered Dabigatran and experience bleeding may often include supportive care such as Hemodialysis and the use of fresh frozen plasma, blood factor products such as prothrombin complex concentrates (PCC), activated prothrombin complex concentrates, and recombinant factor VIIa or delayed intervention. Protamine sulfate and Vitamin K are typically used to reverse the effects of Heparin and Warfarin, respectively. However, due to the mechanism of action in Dabigatran, the applicant maintained that the use of protamine sulfate and Vitamin K may not be effective to reverse the anticoagulant effect of Dabigatran. The applicant provided information regarding the management of major bleeding events experienced by patients who were administered Dabigatran and Warfarin during the RE-LY trial.32 During this study, most major bleeding events were only managed by supportive care. Patients who were administered 150 mg of Dabigatran were transfused with pack red blood cells more often when compared to patients who were administered Warfarin (61.4 percent versus 49.9 percent, respectively). However, patients who were administered Warfarin were transfused with plasma more often when compared to patients who were 32 Healy, et al.: Periprocedural bleeding and thromboembolic events with dabigatran compared with warfarin: results from the randomized evaluation of long-term anticoagulation therapy (RE-LY) randomized trial, Circulation, 2012; 126:343–348. VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 administered 150 mg of Dabigatran (30.2 percent versus 21.6 percent, respectively). In addition, the use of Vitamin K in the treatment of patients who were administered Warfarin was more frequent when compared to the frequency of use in the treatment of patients who were administered 150 mg of Dabigatran (27.3 percent versus 10.3 percent, respectively). The use of PCCs, recombinant factor VIIa and other coagulation factor replacements in the treatment of patients who were administered both Warfarin and 150 mg of Dabigatran was minimal, and did not significantly differ in frequency when compared among patients assigned to either group. Hemodialysis was used in a single case. The applicant reported that, currently, it is recommended that the administration of Dabigatran be discontinued 1 to 2 days (CrCl ≥50 ml/ min) or 3 to 5 days (CrCl <50 ml/min), if possible, before invasive or surgical procedures because of the increased risk of bleeding.33 A longer period of discontinuation time should be considered for patients undergoing major surgery, spinal puncture, or placement of a spinal or epidural catheter or port, if complete hemostasis is required. The applicant stated that delaying emergency medical or surgical procedures can cause urgent conditions to become more severe if intervention is not initiated. The applicant further maintained that delaying emergency medical or surgical procedures for an extended period of time can ultimately lead to negative healthcare outcomes and increased healthcare costs. The applicant asserted that rapidly reversing the anticoagulant effect of Dabigatran administered to patients that require an urgent medical procedure or surgery allows the medical procedure or surgery to be performed in a timely manner, which in turn may decrease complications and minimize the need for more costly therapies. The applicant noted that Idarucizumab was shown to neutralize the anticoagulant effect of Dabigatran in both animal models and healthy human volunteers.34 In a swine blunt liver trauma injury model, the applicant stated that Idarucizumab effectively reversed life-threatening bleeding episodes resulting from trauma in pigs. 33 Pradaxa® (Dabigatran Etexilate Mesylate) prescribing information. Ridgefield, CT: Boehringer Ingelheim; 2014. 34 Honickel, et al.: Reversal of dabigatran anticoagulation ex vivo: Porcine study comparing prothrombin complex concentrates and idarucizumab, Thrombosis and Hemostasis, International Journal for Vascular Biology and Medicine, Vol. 113, April 2015. PO 00000 Frm 00124 Fmt 4701 Sfmt 4702 The applicant also provided data from a randomized, double-blind, placebocontrolled phase I study of healthy male volunteers to investigate the safety, tolerability, and pharmacokinetics of administering single rising doses of Idarucizumab (Part 1) and explore the variant of dosages of Idarucizumab administered to patients that effectively reversed the anticoagulant effect of Dabigatran (Part 2). Safety data is limited in humans to 110 healthy male patients enrolled in the study that were administered dosages of Idarucizumab that ranged from 20 mg to 8 grams. In this study, 135 patients received placebo. The applicant reported that adverse events were generally mild in intensity and non-specific. Healthy human volunteers enrolled in the phase I study (1321.1) were administered Idarucizumab in dosages of 2 and 4 grams, which resulted in immediate and complete reversal of the anticoagulant effect of Dabigatran that was sustained for several hours. The applicant noted that in preclinical studies, the reversal of the anticoagulant effects of Dabigatran was associated with the reversal of bleeding. These effects were consistent in animal models of renal dysfunction, hypovolemia and shock, and trauma related bleeding. The applicant concluded that the data from these studies demonstrates that Idarucizumab effectively, safely, and potently reverses the anticoagulant effect of Dabigatran in both animal models and healthy human volunteers. With regard to the substantial clinical improvement criterion, we believe that Idarucizumab, if approved by the FDA, may represent a treatment option that is not currently available to Medicare beneficiaries and, therefore, represents a substantial clinical improvement. However, we are concerned that the clinical data are not sufficient. Specifically, the applicant provided data from an animal model. In addition, the primary clinical data in relation to human volunteers are based primarily on a trial to measure safety. While the applicant did provide clinical data on the effectiveness of Idarucizumab, we are concerned that the evidence presented does not support the substantial clinical improvement criterion. Specifically, the applicant provided data from a small sample used to demonstrate effectiveness. Usually during clinical studies, phase III of a clinical trial is typically used to gather data from a larger patient population to demonstrate effectiveness. We are inviting public comments on whether or not Idarucizumab meets the substantial E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules clinical improvement criterion, specifically in regard to these concerns. tkelley on DSK3SPTVN1PROD with PROPOSALS2 g. LUTONIX® Drug-Coated Balloon (DCB) Percutaneous Transluminal Angioplasty (PTA) Catheter and IN.PACTTM AdmiralTM Paclitaxel Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter Two manufacturers, CR Bard Inc. and Medtronic, submitted applications for new technology add-on payments for FY 2016 for LUTONIX® Drug-Coated Balloon (DCB) Percutaneous Transluminal Angioplasty (PTA) Catheter (LUTONIX®) and IN.PACTTM AdmiralTM Paclitaxel Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (IN.PACTTM AdmiralTM), respectively. Both of these technologies are drug-coated balloon angioplasty treatments for patients diagnosed with peripheral artery disease (PAD). Typical treatments for patients with PAD include angioplasty, stenting, atherectomy and vascular bypass surgery. PAD most commonly occurs in the femoropopliteal segment of the peripheral arteries, is associated with significant levels of morbidity and impairment in quality of life, and requires treatment to reduce symptoms and prevent or treat ischemic events.35 Treatment options for symptomatic PAD include noninvasive treatment such as medication and life-style modification (for example, exercise programs, diet, and smoking cessation) and invasive options which include endovascular treatment and surgical bypass. The 2013 American College of Cardiology and American Heart Association (ACC/ AHA) guidelines for the management of PAD recommend endovascular therapy as the first-line treatment for femoropopliteal artery lesions in patients suffering from claudication (Class I, Level A recommendation).36 The applicants for LUTONIX® and IN.PACTTM AdmiralTM stated that, in patients diagnosed with PAD, the femoropopliteal artery is characterized by difficult to treat lesions that can be long and diffuse, in a vessel that is considered the most mechanically 35 Tepe G, Zeller T, Albrecht T, Heller S, ¨ Schwarzwalder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U.: Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med 2008; 358: 689–99. 36 Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Guyton RA, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK.: Management of patients with peripheral artery disease (compilation of 2005 and 2011 ACCF/AHA guideline recommendations): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2013; 61:1555–70. Available at: https://dx.doi.org/10.1016/ j.jacc.2013.01.004. VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 stressed artery with a number of dynamic forces that impact the artery including shortening/elongation, torsion, compression and flexion. According to the applicants, the unique challenges of treating the femoropopliteal artery in patients diagnosed with PAD relate to insufficient outcomes from current endovascular therapies, in particular PTA and stent implantations. Coating of femoral and coronary stents with an antiproliferative drug, such as paclitaxel, sirolimus, everolimus, or zotarolimus, that is slowly released when it comes in contact with the arterial wall, is intended to reduce development of restenosis in the stented segment of the artery.37 38 The applicants noted that drug-coated balloon catheters are designed to deliver an antiproliferative drug directly to the arterial segment being dilated. Rather than using a stent to deliver the drug slowly to the dilated area, the drug coating of a balloon is designed to transfer the drug to the arterial wall by direct contact over a few minutes. The applicant maintained that if the drug is absorbed into the arterial wall, rather than being washed away by blood flow once the balloon is deflated, the drug can exert its antiproliferative effects on the vessel with the goal of preventing restenosis. The applicants stated that the drugcoated balloon catheter is a device-drug combination product comprised of a device component (an over-the-wire balloon catheter) and a drug component (a paclitaxel-urea coating in the case of IN.PACTTM and a paclitaxel- sorbitol for LUTONIXTM AdmiralTM) on the balloon, intended for the treatment of patients with PAD, specifically superficial femoral artery (SFA) and popliteal artery disease. The device is engineered for two modes of action: the primary mode of action is attributable to the balloon’s mechanical dilatation of de novo or restenotic lesions in the vessel; and the secondary mode of action consists of drug delivery and application of paclitaxel to the vessel wall to inhibit the restenosis that is normally associated with the proliferative response to the PTA procedure. Following predilatation with a nondrug-coated PTA balloon, the interventionalist selects a drug-coated balloon with diameter of 100 percent of reference vessel diameter (RVD) and length sufficient to treat 5mm proximal 37 Owens, CD.: Drug eluting balloon overview: technology and therapy. Presented at LINC 2011, Leipzig, Germany. 38 Scheller B.: Opportunities and limitations of drug-coated balloon in interventional therapies. Herz 2011;36:232–40. PO 00000 Frm 00125 Fmt 4701 Sfmt 4702 24447 and distal to the target lesion and predilated segment (including overlap of multiple balloons). The interventionalist inflates the drugcoated balloon for a minimum inflation time of 30 seconds for delivery of paclitaxel, and keeps the balloon inflated for as long as necessary to achieve a satisfactory procedural result, which is the standard of care for all balloon angioplasties. According to both applicants, LUTONIX® and IN.PACTTM AdmiralTM are the first drug coated balloons that can be used for treatment of patients who are diagnosed with PAD. Because cases eligible for the two devices would group to the same MS–DRGs and we believe that these devices are substantially similar to each other (that is, they are intended to treat the same or similar disease in the same or similar patient population and are purposed to achieve the same therapeutic outcome using the same or similar mechanism of action), we believe that it is appropriate to evaluate both technologies as one application for new technology add-on payment under the IPPS. The applicants submitted separate cost and clinical data, and we reviewed and discuss each set of data separately. However, we intend to make one determination regarding new technology add-on payments that will apply to both devices. We believe that this is consistent with our policy statements in the past regarding substantial similarity. Specifically, we have noted that approval of new technology add-on payments would extend to all technologies that are substantially similar (66 FR 46915), and that we believe that continuing our current practice of extending a new technology add-on payment without a further application from the manufacturer of the competing product or a specific finding on cost and clinical improvement if we make a finding of substantial similarity among two products is the better policy because we avoid— • Creating manufacturer-specific codes for substantially similar products; • Requiring different manufacturers of substantially similar products from having to submit separate new technology applications. • Having to compare the merits of competing technologies on the basis of substantial clinical improvement; and • Bestowing an advantage to the first applicant representing a particular new technology to receive approval. (70 FR 47351) If these substantially similar technologies had been submitted for review in different (and subsequent) E:\FR\FM\30APP2.SGM 30APP2 24448 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules years, rather than the same year, we would evaluate and make a determination on the first application and apply that same determination to the second application. However, because the technologies have been submitted for review in the same year, we believe it is appropriate to consider both sets of cost data and clinical data in making a determination because we do not believe that it is possible to choose one set of data over another set of data in an objective manner. CR Bard, Inc. received FDA approval for LUTONIX® on October 9, 2014. Commercial sales in the U.S. market began on October 10, 2014. Medtronic received FDA approval for IN.PACTTM AdmiralTM on December 30, 2014. Commercial sales in the U.S. market began on January 29, 2015. As stated in section II.G.1.a. of the preamble of this proposed rule, effective October 1, 2015 (FY 2016), the ICD–10 coding system will be implemented. We note that the applicant submitted a request and presented at the September 2014 ICD–10 Coordination and Maintenance Committee Meeting to create ICD–10– PCS codes to uniquely identify drugcoated PTA balloons used for treating ICD–10–PCS code 047K041 047K0D1 047K0Z1 047K341 047K3D1 047K3Z1 047K441 ....................... ....................... ....................... ....................... ....................... ....................... ....................... 047K4D1 ....................... 047K4Z1 ....................... 047L041 ........................ 047L0D1 ....................... 047L0Z1 ........................ 047L341 ........................ 047L3D1 ....................... 047L3Z1 ........................ 047L441 ........................ 047L4D1 ....................... 047L4Z1 ........................ 047M041 ....................... 047M0D1 ...................... 047M0Z1 ....................... 047M341 ....................... 047M3D1 ...................... 047M3Z1 ....................... 047M441 ....................... 047M4D1 ...................... 047M4Z1 047N041 047N0D1 047N0Z1 047N341 047N3D1 047N3Z1 047N441 ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... tkelley on DSK3SPTVN1PROD with PROPOSALS2 047N4D1 ....................... 047N4Z1 ....................... Code description Dilation of right femoral artery with drug-eluting intraluminal device using drug-coated balloon, open approach. Dilation of right femoral artery with intraluminal device using drug-coated balloon, open approach. Dilation of right femoral artery using drug-coated balloon, open approach. Dilation of right femoral artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous approach. Dilation of right femoral artery with intraluminal device using drug-coated balloon, percutaneous approach. Dilation of right femoral artery using drug-coated balloon, percutaneous approach. Dilation of right femoral artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous endoscopic approach. Dilation of right femoral artery with intraluminal device using drug-coated balloon, percutaneous endoscopic approach. Dilation of right femoral artery using drug-coated balloon, percutaneous endoscopic approach. Dilation of left femoral artery with drug-eluting intraluminal device using drug-coated balloon, open approach. Dilation of left femoral artery with intraluminal device using drug-coated balloon, open approach. Dilation of left femoral artery using drug-coated balloon, open approach. Dilation of left femoral artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous approach. Dilation of left femoral artery with intraluminal device using drug-coated balloon, percutaneous approach. Dilation of left femoral artery using drug-coated balloon, percutaneous approach. Dilation of left femoral artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous endoscopic approach. Dilation of left femoral artery with intraluminal device using drug-coated balloon, percutaneous endoscopic approach. Dilation of left femoral artery using drug-coated balloon, percutaneous endoscopic approach. Dilation of right popliteal artery with drug-eluting intraluminal device using drug-coated balloon, open approach. Dilation of right popliteal artery with intraluminal device using drug-coated balloon, open approach. Dilation of right popliteal artery using drug-coated balloon, open approach. Dilation of right popliteal artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous approach. Dilation of right popliteal artery with intraluminal device using drug-coated balloon, percutaneous approach. Dilation of right popliteal artery using drug-coated balloon, percutaneous approach. Dilation of right popliteal artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous endoscopic approach. Dilation of right popliteal artery with intraluminal device using drug-coated balloon, percutaneous endoscopic approach. Dilation of right popliteal artery using drug-coated balloon, percutaneous endoscopic approach. Dilation of left popliteal artery with drug-eluting intraluminal device using drug-coated balloon, open approach. Dilation of left popliteal artery with intraluminal device using drug-coated balloon, open approach. Dilation of left popliteal artery using drug-coated balloon, open approach. Dilation of left popliteal artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous approach. Dilation of left popliteal artery with intraluminal device using drug-coated balloon, percutaneous approach. Dilation of left popliteal artery using drug-coated balloon, percutaneous approach. Dilation of left popliteal artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous endoscopic approach. Dilation of left popliteal artery with intraluminal device using drug-coated balloon, percutaneous endoscopic approach. Dilation of left popliteal artery using drug-coated balloon, percutaneous endoscopic approach. As we discuss above, the approval of new technology add-on payments would extend to all technologies that are substantially similar. Otherwise, our payment policy would bestow an advantage to the first applicant to receive approval for a particular new technology (66 FR 46915). Moreover, as we discuss above, we believe that VerDate Sep<11>2014 PAD. More information on this request can be found on the CMS Web site at: https://www.cms.gov/Medicare/Coding/ ICD9ProviderDiagnosticCodes/ICD-9CM-C-and-M-Meeting-Materials.html. We received public comments during and after the ICD–10 Coordination and Maintenance Committee meeting that supported the creation of unique codes to identify the use of a drug-coated balloon in procedures performed for treating PAD. As a result, the following ICD–10–PCS codes listed in the table below were created and are effective October 1, 2015 (FY 2016): 18:20 Apr 29, 2015 Jkt 235001 applications for substantially similar technologies should be evaluated in a manner that avoids, among other things, having to compare the merits of competing technologies on the basis of substantial clinical improvement. If we receive applications for substantially similar technologies in different years, we would apply the first determination PO 00000 Frm 00126 Fmt 4701 Sfmt 4702 to any subsequent applications for substantially similar technologies. However, because, in this case, two substantially similar technologies have applied for a new technology add-on payment for the same Federal fiscal year, we believe it is consistent with our policy to make one determination using all of the information submitted for the E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules technologies rather than choosing one set of information to consider and not considering the other set of information. We believe that, in accordance with our policy, it is appropriate to use the earliest market availability date submitted as the beginning of the newness period. Accordingly, for both devices, based on our policy, if approved for new technology add-on payments, we believe that the beginning of the newness period would be October 10, 2014. We are inviting public comments on whether these two technologies meet the newness criterion. As we stated above, each applicant submitted separate analyses regarding the cost criterion for each of their devices and both applicants maintained that their device meets the cost criterion. We summarize each analysis below. With regard to LUTONIX®, to demonstrate that the technology meets the cost criterion, the applicant performed three different analyses. The applicant first searched the FY 2013 MedPAR data file that was used for the recalibration of the FY 2015 MS–DRG relative payment weights in the FY 2015 IPPS/LTCH PPS final rule. The applicant applied the standard trims that CMS used when selecting cases for IPPS rate recalibration as described in the FY 2015 IPPS/LTCH PPS final rule (79 FR 49911). In other words, the applicant included cases from IPPS hospitals and Maryland hospitals and excluded cases paid by Medicare Advantage plans, cases from hospitals that did not submit charges in a sufficiently broad range of revenue centers, and statistical outlier cases as described in the FY 2015 IPPS/LTCH PPS final rule. The applicant then searched for all claims reporting ICD–9– CM procedure code 39.50 (Angioplasty of other non-coronary vessel(s)) and also reporting at least one of the following seven ICD–9–CM diagnosis codes (440.20 (Atherosclerosis of native arteries of the extremities, unspecified), 440.21 (Atherosclerosis of native arteries of the extremities with intermittent claudication), 440.22 (Atherosclerosis of native arteries of the extremities with rest pain), 440.23 (Atherosclerosis of native arteries of the extremities with ulceration), 440.24 (Atherosclerosis of native arteries of the extremities with gangrene), 440.29 (Other atherosclerosis of native arteries of the extremities), and 443.9 (Peripheral vascular disease, unspecified indicating peripheral artery disease). The applicant excluded all claims that reported any ICD–9–CM procedure codes involving a stent. A VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 total of 23,157 cases reporting peripheral angioplasty were identified. Of these 23,157 cases, MS–DRGs 252, 253, and 254 (Other Vascular Procedures with MCC, with CC and without CC/MCC, respectively) accounted for 65 percent of cases; MS– DRGs 237 and 238 (Major Cardiovascular Procedures with MCC and without MCC, respectively), MS– DRGs 239 and 240 (Amputation for Circulatory System Disorders Except Upper Limb and Toe with MCC and with CC, respectively), and MS–DRG 853 (Infectious and Parasitic Diseases with Operating Room Procedure with MCC) accounted for 17 percent of cases (among these, peripheral angioplasty was secondary to some other circulation-related procedure: a major cardiovascular procedure (MS–DRGs 237 and 238), amputation due to poor circulation (MS–DRGs 239 and 240), or (typically) amputation with sepsis (MS– DRG 853)). The remaining 18 percent of cases were spread across a large number of other MS–DRGs. Next, the applicant obtained the average case-weighted charge per case based on the distribution of cases by MS–DRG and then identified the average caseweighted threshold for the three MS– DRG groupings from the threshold amounts in Table 10 of the FY 2015 IPPS/LTCH PPS final rule. The applicant then calculated the unadjusted (unstandardized) average case-weighted charge per case for all MS–DRGs. According to the applicant, charges were not removed for any prior technology. To estimate the charge 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, to arrive at the average caseweighted standardized charges per case. The average case-weighted standardized charges per case for the three primary MS–DRGs 252–254 group (65 percent), the five additional MS–DRGs 237–240 and MS–DRG 853 group (17 percent), and the other MS–DRGs (18 percent) were $69,243, $81,156, and $95,138, respectively. The applicant then inflated the average standardized case-weighted charges per case from FY 2013 to FY 2015 using the 2-year inflation factor of 10.44 percent specified in the FY 2015 IPPS/LTCH PPS final rule and added charges related to the new technology to the average case-weighted standardized charges per case, although the applicant indicated that it was not clear on the need to include an inflation factor. The final inflated average case-weighted standardized charges per case for the three primary MS–DRG groups (65 PO 00000 Frm 00127 Fmt 4701 Sfmt 4702 24449 percent), the five additional MS–DRG groups (17 percent), and across other MS–DRGs (18 percent) were $85,386, $98,543, and $104,052, respectively. Because the final inflated average caseweighted standardized charge amounts exceed the corresponding average caseweighted threshold amounts of $69,594, $74,449, and $75,215, respectively, using the FY 2015 IPPS Table 10, the applicant maintained that the LUTONIX® meets the cost criterion for new technology add-on payments. With regard to IN.PACTTM AdmiralTM, to demonstrate that the technology meets the cost criterion, the applicant performed two different analyses. The applicant believed that a case involving an angioplasty procedure that used the IN.PACTTM AdmiralTM drug-coated balloon catheter would map to the same MS–DRGs as a case involving a plain balloon angioplasty procedure, MS–DRGs 252, 253, and 254 (Other Vascular Procedures with MCC, with CC, and without CC/MCC, respectively). The applicant first searched the FY 2013 MedPAR claims data that were used for the recalibration of the FY 2015 MS–DRG relative payment weights in the FY 2015 IPPS/ LTCH PPS final rule. The data in this file included discharges occurring on October 1, 2012 through September 30, 2013. The applicant excluded claims for all discharges for Medicare beneficiaries enrolled in a Medicare Advantage plan. The applicant also limited claims to those hospitals that were included in the FY 2013 IPPS Final Rule Impact File. In addition, the applicant removed claims in accordance with the trims specified in the FY 2013 IPPS/LTCH PPS final rule (77 FR 53326) that were used to recalibrate the MS–DRG relative payment weights. The applicant then searched for all claims reporting ICD–9– CM procedure code 39.50 (Angioplasty of other non-coronary vessel(s)) in combination with claims reporting at least one of the following seven ICD–9– CM diagnosis codes (440.20 through 440.24, 440.29, and 443.9) indicating peripheral artery disease. The applicant excluded all claims that reported any ICD–9–CM procedure codes for stent implantation. The applicant believed that excluding all cases reporting stenting procedures would potentially underestimate the average charges for cases reporting peripheral angioplasty. A total of 23,157 cases involving peripheral angioplasty procedures were identified. Of these 23,157 cases, a majority (65 percent; 15,040 cases) mapped to one of the 3 primary MS– DRGs, MS–DRGs 252, 253, or 254. The remaining 35 percent of the cases E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 24450 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules (8,117) were assigned to a number of MS–DRGs other than the 3 primary MS– DRGs. Next, the applicant determined the distribution of cases by MS–DRG and the case-weighted threshold amounts from Table 10 in the FY 2015 IPPS/LTCH PPS final rule, for both the primary MS–DRG group and the total MS–DRG group. The applicant began by calculating the unadjusted (unstandardized) case-weighted average charge per case for all MS–DRGs. Following this computation, the applicant standardized the charges on each of the identified claims using the FY 2013 factors from the FY 2015 IPPS/ LTCH PPS Final Rule Impact File, to match the year of the claims data used in this analysis (FY 2013 MedPAR file). According to the applicant, charges were not removed for any other specific technologies that may have been used because the applicant expected that a plain balloon will be utilized to predilate the vessel in a majority of drug-coated balloon angioplasty cases prior to the use of the drug-coated balloon (that is, the applicant did not believe it was necessary to remove charges associated with the other specific prior technology (a plain PTA balloon catheter in this case). The applicant then inflated the average caseweighted standardized charges per case from FY 2013 to FY 2015 using the 2year inflation factor of 10.44 percent specified in the FY 2015 IPPS/LTCH PPS final rule and added charges related to the new technology to the average charges per case. The final inflated average case-weighted standardized charge per case both for the primary MS–DRGs group and the total MS–DRG group were $82,944 and $101,611, respectively. Because the final inflated average case-weighted standardized charge per case for the applicable MS– DRG exceeds the average case-weighted threshold amounts of $69,594 and $75,215, respectively, using the FY 2015 IPPS Table 10, the applicant maintained that the IN.PACTTM AdmiralTM technology meets the cost criterion for new technology add-on payments. We are concerned that both applicants excluded cases of patients that received stent implantations from their analysis because the applicants believed that their technology can be used instead of stenting. We are seeking public comments on whether LUTONIX® and IN.PACTTM AdmiralTM meet the cost criterion. With regard to substantial clinical improvement, the applicant believed that LUTONIX® represents a substantial clinical improvement because it meets an unmet clinical need by providing access to ‘‘no stent zones’’ and because VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 it can achieve greater patency; preserve the flexibility of future interventions; and address stent fractures and restenosis.39 40 The applicant shared the findings from its LEVANT 1 and LEVANT 2 trials. LEVANT 1: In the LEVANT 1 trial, 101 patients were randomized to a LUTONIX® drug-coated balloon treatment group or a control group that received percutaneous transluminal angioplasty (PTA) only. The primary endpoint of mean angiographic Late Lumen Loss at 6 months favored the LUTONIX® drug-coated balloon treatment group (0.46±1.13) compared to the control PTA group (1.09±1.07), with a p-value of 0.016. We are concerned that the results were not statistically significant with regard to the p-value documented. Adverse events were similar for both groups and through 24 months; the percentage of patients with any death, amputation, or target vessel thrombosis was 8 percent in the treatment group compared to 12 percent in the control group. LEVANT 2: The LEVANT 2 study is the applicant’s pivotal study that was conducted as a prospective, multicenter, single blind, 2:1 (test: control) randomized trial comparing the LUTONIX® drug-coated balloon angioplasty to standard balloon angioplasty used during the treatment of patients with femoropopliteal arteries. The applicant documented that the patient characteristics and lesions in both groups were well-matched; 43 percent of patients were diabetic; 35 percent were current smokers; 37 percent were female; and 8 percent had critical limb ischemia. The study was conducted to show that drug-coated balloon angioplasty improves clinical outcomes for a patient population as compared to currently available treatments. All endpoints were adjudicated by a blinded Clinical Events Committee (CEC) and duplex ultrasound and angiographic core laboratories. The applicant specified two primary endpoints that must both be met in order for the study to be successful. The first endpoint was primary patency at 12 months, defined as freedom from target lesion restenosis and target lesion revascularization (TLR). The results were the following: primary patency for LUTONIX® was 65.2 percent compared 39 Scheinert, D., et al.: Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol, 2005. 45(2): p. 312–5. 40 Klein, A.J., et al.: Quantitative assessment of the conformational change in the femoropopliteal artery with leg movement. Catheter Cardiovasc Interv, 2009. 74(5): p. 787–98. PO 00000 Frm 00128 Fmt 4701 Sfmt 4702 to primary patency of 52.6 percent for PTA. Kaplan-Meier analysis was 73.5 percent for LUTONIX® compared to 56.8 percent for PTA (p <0.001). The second primary efficacy endpoints were composite safety endpoints at 12 months, which included freedom from index-limb amputation; reintervention and related death. The results were 83.9 percent for LUTONIX® compared to 79.0 percent for PTA. The secondary efficacy endpoints at 12 months for this trial were freedom from Target lesion revascularization (TLR), and the results were 89.7 percent for the LUTONIX® treatment group compared to 84.8 percent for the PTA control group, with p = 0.17. Another end point was freedom from Target vessel revascularization (TVR), where the result for the LUTONIX® treatment group was 76.2 percent compared to 66.6 percent in the control group with a p-value of 0.041. Clinical indicators, such as Ankle brachial index (ABI), Rutherford scores (categorization of symptomology), quality of life (QOL), walking distance, and walking impairment WIQ, were significantly improved with a p-value of <0.001. The applicant assessed the primary safety endpoint using Kaplan-Meier survival analysis and stated that there was no evidence of statistical difference. We are concerned that the patient population studied may not reflect the Medicare population. In particular, we note that only 37 percent of the studied patients were female. For instance, it could be beneficial to see additional subgroup analyses to test for statistical interaction between treatment and subgroups to ascertain that there is no imbalance in response to different subpopulations, such as males versus females. With regard to substantial clinical improvement for the IN.PACTTM AdmiralTM, the applicant stated that evidence demonstrates that the technology significantly improves key clinical outcomes compared to previous technologies for patients with intermittent claudication. Examples of such key clinical outcomes included a decrease in recurrence of restenosis (disease process); a decrease in rates of repeat interventions (subsequent therapeutic interventions); a decrease in future hospitalizations; improved patient symptoms (decreased pain), and improvement in quality of life and function. To further demonstrate substantial clinical improvement, the applicant asserted that historical proofof-concept research has demonstrated the utility of various drug-coated balloon technologies in reducing restenosis and reintervention compared E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules tkelley on DSK3SPTVN1PROD with PROPOSALS2 with PTA.41 42 With this assertion, the applicant stated that there was no evidence of the promising primary patency and target lesion revascularization rates from large randomized controlled trials. This led the applicant to design the IN.PACTTM SFA Trial. The IN.PACTTM SFA Trial is a prospective, randomized-controlled, global, multicenter, single-blinded study conducted with independent, blinded adjudication of all key endpoints. The primary safety end point was freedom from device-related and procedurerelated death through 30 days, and freedom from target limb major amputation and clinically-driven TVR through 12 months. The primary effectiveness endpoint was primary patency, a composite endpoint comprising an anatomic measure (binary restenosis as measured by duplex ultrasound or angiography) and a clinical measure (Clinically Driven Target Lesion Revascularization (CD– TLR)). The IN.PACTTM SFA Trial was designed as a two-phase, global, multicenter trial in which 331 patients with symptoms of claudication or rest pain and with a positive diagnostic finding of de novo stenosis and/or nonstented restenotic lesions in the SFA and/or popliteal artery (PPA) were randomized in a 2:1 fashion to treatment with IN.PACTTM Admiral TM drugcoated balloon or uncoated balloon angioplasty. The trial was prospectively designed to be conducted in two phases: IN.PACTTM SFA Phase I (conducted in Europe) and IN.PACTTM SFA Phase II (conducted in the United States), jointly referred to as IN.PACTTM SFA Trial. According to the applicant, the patient demographics were well-matched and of which 34 percent were women. We are concerned that the applicant did not match the gender variable. The applicant noted that, during the SFA Trial, both the study subjects and trial sponsor were blinded to the treatment assignments through completion of the 12-month primary endpoint evaluations. The applicant also stated that the independent Clinical Events Committee and the Core Laboratories were blinded to the treatment assignment and the duration of the follow-up of study participants. In addition, operators 41 Werk M, Albrecht T, Meyer DR, Ahmed MN, Behne A, Dietz U, Eschenbach G, Hartmann H, Lange C, Schnorr B, Stiepani H, Zoccai GB, ¨ Hanninen EL.: Paclitaxel-coated balloons reduce restenosis after femoropopliteal angioplasty: evidence from the randomized PACIFIER trial. Circ Cardiovasc Interv 2012 5: 831–40. 42 Tepe G, Zeller T, Albrecht T, Heller S, ¨ Schwarzwalder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U.: Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med 2008; 358: 689–99. VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 (implanting physicians and catheterization laboratory staff, including research coordinators) were not blinded to the treatment delivered due to macroscopic visual differences between IN.PACTTM AdmiralTM drugcoated balloon and control technology. The applicant reported the following: The primary endpoints were: Improved primary patency rates in the IN.PACTTM AdmiralTM drug-coated balloon arm compared to the control arm; and primary patency within 12 months is defined as freedom from clinically driven target lesion revascularization and freedom from restenosis as determined by duplex ultrasonography peak systolic velocity ratio ≤2.4 or ≤50 percent stenosis as assessed by angiography. Results showed that the 12-month primary patency rate was 82.2 percent in the IN.PACTTM AdmiralTM drug-coated balloon arm versus 52.4 percent in the PTA arm (P <0.001). In addition, the 12-month freedom from binary restenosis (assessed by DUS/ angiography) was 83.5 percent in the IN.PACTTM AdmiralTM drug-coated balloon group compared to 66.3 percent in the PTA group (P = 0.001). The second endpoint measured was AnkleBrachial Index (ABI) showing 0.951 in the IN.PACTTM AdmiralTM drug-coated balloon arm compared to 0.866 in the control arm, P = 0.002. The ABI is an objective hemodynamic measure used to predict the severity of PAD in the lower extremity. The test is done by comparing the systolic blood pressure at the ankle and the systolic blood pressure in the arm while a person is at rest. In general, higher values are better than lower values; a normal resting ankle-brachial index is from 1.0 to 1.4, an abnormal resting ankle-brachial index is 0.9 or lower and an ABI of 0.91 to 0.99 is considered borderline abnormal.43 Secondary endpoints were primary sustained clinical improvement, defined as freedom from target limb amputation, target vessel revascularization, and increase in Rutherford class; comparing IN.PACTTM AdmiralTM with the control arm was 85.2 percent versus 68.9 percent; P <0.001. The rate of repeat target lesion revascularization (TLR), defined by the applicant as repeat revascularization of the target lesion by percutaneous endovascular treatment or bypass surgery, was 2.4 percent in the IN.PACTTM AdmiralTM drug-coated balloon arm compared to 20.6 percent in 43 Hirsch AT, Haskal ZJ, Hertzner NR, et al.: ACC/ AHA guidelines for the management of subjects with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aorta): executive summary. J Am Coll Cardiol 2006;47:1239–312. PO 00000 Frm 00129 Fmt 4701 Sfmt 4702 24451 the control arm. In addition, the target vessel revascularization (TVR) procedures (that is, any revascularization done to any segment of the entire target vessel that may reflect restenosis of a target lesion or disease progression causing a new lesion in the target artery) 44 was 4.3 percent in the IN.PACTTM AdmiralTM drug-coated balloon arm compared to 23.4 percent in the control arm with a p-value of <0.001). Other secondary endpoints were conducted and the patients were followed at 1, 6, and 12 months to assess the following claudication symptoms: EQ–5D; Walking Impairment Questionnaire (WIQ); 6-minute walk test in a subset. Claudication symptoms were 7.3 percent in the IN.PACTTM AdmiralTM drug-coated balloon arm compared to 20.7 percent in the control arm. For WIQ (defined as the ability of PAD patients to walk defined distances and speeds, plus climb stairs, thus evaluating claudication severity levels 45), the gains in improvement were similar in both groups. The 6minute walk test, which is a measure of functional exercise capacity, was equivocal in both arms. Quality of life (QOL) was measured using five domains of the EQ–5D (mobility, self-care, usual activities, pain/discomfort, and anxiety/ depression) and was found to be equivocal. The applicant also conducted extensive subgroup analyses of the primary safety end point, efficacy endpoint, and TLR rates to assess the response to IN.PACTTM AdmiralTM in various subpopulations, including: Rutherford category (2, 3, and 4); diabetes; age (≥75); lesion length (<5 cm, ≥5 cm to <10 cm, ≥10 cm to <18 cm); total occlusion, and gender. According to the applicant, although the trial was not designed to power the subgroup analyses, in 9 of these 11 subgroups, patients in the IN.PACTTM AdmiralTM treatment group were shown to have statistically significant better outcomes than patients in the PTA control group 44 Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J.: Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation 2008;118: 1358–65. 45 Jones WS, Schmit KM, Vemulapalli S, Subherwal S, Patel MR, Hasselblad V, Heidenfelder BL, Chobot MM, Posey R, Wing L, Sanders GD, Dolor RJ.: Treatment Strategies for Patients With Peripheral Artery Disease. Comparative Effectiveness Review No. 118. (Prepared by the Duke Evidence-based Practice Center under Contract No. 290–2007–10066–I.) AHRQ Publication No. 13–EHC090–EF. Rockville, MD: Agency for Healthcare Research and Quality; May 2013. Available at: https:// www.effectivehealthcare.ahrq.gov/reports/final. E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 24452 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules in the primary effectiveness and safety endpoints as well as clinically-driven TLR. This includes subgroups: Rutherford categories 2 & 3; diabetes; age (≥75); lesion length ≥5 cm to <10 cm; lesion length ≥10 cm to <18 cm; total occlusion; and gender (both male and female). In the two subgroups that did not meet statistical significance (Rutherford category 4 and lesion length <5 cm), data for the primary effectiveness and safety endpoints as well as the clinically driven TLR trended in favor of IN.PACTTM AdmiralTM. We are concerned about the clinical meaningfulness of some of the endpoints measured by the trials conducted by the applicant. For example, there were no changes in functional measures such as walking distances. The applicant indicated that this may be because patients in the control group had additional procedures to the point their symptoms were controlled to the same extent as those of the drug-coated balloon group. We believe that this assertion could be better supported with data. Another related example is the higher anklebrachial index in the drug-coated balloon catheter group. While this is also consistent with an enduring physiologic effect of the drug-coated balloon device, we are concerned that these ABI measurements appear to have been made by unblinded study personnel. We are concerned that the IN.PACTTM AdmiralTM technology may not be the optimal treatment for all patients diagnosed with peripheral arterial disease. The drug-coated balloon catheter has been compared only with a standard balloon, and no other alternatives, such as stents, surgery, or intensive exercise therapy. Therefore, it is unknown whether a drug-coated balloon strategy would yield the same, better, or worse outcomes than these alternatives. We also note that while there appears to be broader anatomical applicability, not all of the studies provided definitively indicate that it is a clinical improvement over PTA. We are seeking public comment on whether LUTONIX® and IN.PACTTM AdmiralTM meet the substantial clinical improvement criterion, specifically with regard to our concerns discussed. Below we summarize the written public comments on the LUTONIX® and IN.PACTTM AdmiralTM technologies that we received in response to the town hall meeting. Comment: One commenter, a major society on vascular medicine, stated that without new technology add-on payments for drug-coated balloon VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 catheters, facilities will not be adequately compensated for procedures involving these devices and patient access to these new beneficial technologies will be hampered. The commenter believed that the technology being developed by both manufacturers meets the newness criterion. The commenter stated that the drug-coated balloon catheters represent advancement in medical technology that substantially improves, relative to technologies previously available, the treatment of Medicare beneficiaries. Specifically, the commenter stated that the results of the clinical trials for these devices have established that these devices achieve more durable patency by reducing restenosis, which in turn reduces the rate of repeat interventions. The commenter further stated that these devices do not require a permanent implant, which preserves future treatment options. The commenter also noted documented improvements treatment results for patients diagnosed with PAD according to an article in the JAMA.46 The commenter expressed support for approval of new technology add-on payments for both the LUTONIX® and the IN.PACTTM AdmiralTM technologies, with hopes of minimizing any financial barriers that might prevent patients from having access to this technology. Another commenter supported the approval of new technology add-on payments for the LUTONIX® and IN.PACTTM AdmiralTM technologies and for other drug-coated balloon catheters in the treatment of patients diagnosed with SFA in the United States. Specifically, the commenter stated that the clinical study results have shown that using drug-coated balloon catheters both keep a vessel open for a longer period of time and reduce the total number of repeat procedures that may need to be performed. The commenter further stated that treatment using existing therapies in his own practice have resulted in patients returning for repeat procedures 1 to 2 times per year. The commenter noted that the additional benefit of reducing revascularization, which allows patients to remain mobile for longer periods of time, further reduces potential complications and hospitalizations. The commenter also noted that colleagues outside the United States have had access to this technology for over 5 years and the technology’s use has shown positive results in different 46 Goodney, Tarulli, Faerber, et al. Fifteen-Year Trends in Lower Limb Amputation, Revascularization, and Preventive Measures Among Medicare Patients. JAMA Surg. 2015;150(1):84–86. PO 00000 Frm 00130 Fmt 4701 Sfmt 4702 patient and lesion subgroups, which provides strong evidence that supports the wide use of drug-coated balloon catheters. The commenter stated that there are a number of publications that advocate that the reduced need for revascularization also results in significant cost savings for health care systems, and recommended that these additional savings and value to be shared with hospitals in the United States. The commenter stated that, although there is clear clinical evidence that supports the use of drug-coated balloon catheters, there are concerns that hospital administrators may limit the use of these catheters because of the added cost burden that would be completely imposed on hospitals in the current health care system. Response: We appreciate the commenters’ input. We will consider these comments in our analysis and final determination of the applications for new technology add-on payments for FY 2016. h. VERASENSETM Knee Balancer System (VKS) OrthoSensor submitted an application for new technology add-on payments for the VERASENSETM Knee Balancer System (VKS) for FY 2016. The VKS is a sterile, single patient use device to intraoperatively provide a means to dynamically balance the patient’s knee during total knee arthroplasty (TKA) surgery. The applicant maintained that quantitative metrics, viewed on a monitor through real time wireless information, enable the surgeon to improve soft tissue stability and kinetics during TKA surgery. The VKS device includes a tibial trial insert composed of an array of responsive sensors that delivers quantified kinetic balance data during TKA surgery. The quantitative data provides a basis for the surgeon to make data-based decisions regarding tissue dissection during TKA surgeries, resulting in a more stable outcome. According to the applicant, the VKS device combines dual sensor elements, coupled with micro-processing technology, to accurately depict intraarticular kinetics and contact point locations within the knee. The tibial trial insert is placed in the knee capsule. Proper placement of the insert does not require any force or infiltration of the bone or soft tissue in the knee. The applicant stated that the VKS device uses wireless communication protocols that overcome line-of-sight or other interference issues, therefore eliminating the need for line-of-sight or direct antenna-based tracking during the TKA surgery. E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules The first version of the VKS received FDA approval in 2009 for the OrthoRex Intra-Operative Load Sensor. The device was indicated for use as a tool to adjust the femoral knee implant to reduce instability from flexion gap asymmetry using a single patient use sterile force sensor. The applicant noted that the first version of the VKS was not available on the U.S. market at the time of FDA approval in 2009. The applicant stated that the 510K approval from the FDA allowed permission to continue to test the device and improve upon the specificity of the sensors. The applicant stated that the first version of the VKS did not enter on the U.S. market until late 2011. Further advancements were made to the VKS to more accurately refine the sensor specificity, which provides more accurate balance data unique to the contours of specific knee implant components. The applicant further explained that the tibial trial sensor was redesigned to respond quantitatively and specifically to the variations of the contours of specifically manufactured knee implants. The advanced sensor specificity, developed in conjunction with data gained from clinical trials, provides information regarding force and balance metrics that aid the surgeon’s understanding and measurement of knee balance. The applicant noted that without the advancements to the sensor specificity, which were perfected based on knowledge gained from the clinical trials, the sensor would not be as clinically useful as it is currently. These advancements resulted in additional FDA clearances on June 13, 2013, and October 14, 2013. The product’s description was updated on January 28, 2014. The applicant maintained that the VKS meets the newness criterion. The applicant analyzed the relative weights from 2010 to 2014 for the MS–DRGs that may contain cases that would be eligible for the advanced VKS technology (MS– DRGs 461 through 470). The applicant noted that there was no increase in the calculation of the FY 2014 or FY 2015 relative weights for these MS–DRGs to represent the additional cost of the advanced VKS technology. We are concerned that the advancements made to the VKS that resulted in the additional FDA approval clearances in 2013 may not be significant enough to distinguish the advanced technology from the first version of the VKS, which received FDA approval in 2009. We believe that the advanced VKS may be substantially similar to the first version of the VKS (that was first available on the U.S. market in late 2011) and, therefore, VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 would not meet the newness criterion. In addition, the costs associated with the VKS should be reflected in the FY 2013 and subsequent relative payment weights for these MS–DRGs because the product has been available and used for the Medicare population since 2011. 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 the 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 the application under the substantial similarity criteria, we believe that the first version of the VKS and the advance version of the VKS use the same mechanism of action to achieve the desired outcome by using a sterile device that is equipped with sensors used to adjust the femoral knee implant to reduce instability from flexion gap asymmetry. In addition, we believe that cases involving the first version of the VKS would be assigned to the same MS–DRG as the cases involving the advanced VKS. Moreover, we believe that both the first version of the VKS and the advanced version of the VKS treat the same or similar disease and the same or similar patient population. Specifically, both of the VKS technologies are used in the treatment of patients undergoing TKA surgery. Because we believe that the technology meets all three of the substantial similarity criteria, we believe that the beginning of the newness period for this technology would commence when it became available on the U.S. market in late 2011. Therefore, the VKS may not be considered ‘‘new’’ for purposes of new technology add-on payments. As discussed in the FY 2005 IPPS final rule (69 FR 49003), once data become available to reflect the cost of the technology in the relative weights, the technology can no longer be considered ‘‘new’’ and eligible to receive new technology add-on payments. Section 412.87(b)(2) states that a medical service or technology may be considered new within 2 or 3 years after the point at which data begin PO 00000 Frm 00131 Fmt 4701 Sfmt 4702 24453 to become available reflecting the ICD– 9–CM code assigned to the new service or technology (depending on when a new code is assigned and data on the new service or technology become available for DRG recalibration). Further, after CMS has recalibrated the DRGs, based on available data, to reflect the costs of an otherwise new medical service or technology, the medical service or technology will no longer be considered ‘‘new’’ under the criterion of this section. Therefore, we believe that the costs of this technology are included in the charge data and the MS–DRGs have been recalibrated using that data. Therefore, the technology can no longer be considered ‘‘new’’ for the purposes of this provision, regardless of whether or not there was an increase in the MS– DRG relative weights during FYs 2014 and 2015, specifically because of the inclusion of the cost of the technology. As previously stated, we believe that the beginning of the newness period for the VKS commenced when the product was first made available on the U.S. market in late 2011. The 3-year anniversary date of the product’s availability on the U.S. market occurred in late 2014, which is prior to the beginning of FY 2016. Therefore, we do not believe that the VKS technology can be considered ‘‘new’’ for purposes of new technology add-on payments. We are inviting public comments regarding whether or not the VKS technology is substantially similar to existing technologies, and whether or not the VKS technology meets the newness criterion. Currently, there are no ICD–9–CM or ICD–10–PCS procedure codes that uniquely identify the use of this technology. As stated above, effective October 1, 2015 (FY 2016), the ICD–10 coding system will be implemented. The applicant submitted a request for a unique ICD–10–PCS code that was presented at the March 18, 2015 ICD–10 Coordination and Maintenance Committee meeting. If approved, the code(s) will be effective on October 1, 2015 (FY 2016). More information on this request can be found on the CMS Web site located at the following link: https://www.cms.gov/Medicare/Coding/ ICD9ProviderDiagnosticCodes/ICD-9CM-C-and-M-Meeting-Materials.html. With regard to the cost criterion, the applicant supplied three analyses to demonstrate that it meets the cost criterion. The applicant believed that cases that are eligible for the VKS technology map to MS–DRGs 461 and 462 (Bilateral or Multiple Major Joint Procedures of Lower Extremity with MCC and without MCC, respectively), MS–DRGs 466 through 468 (Revision of E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 24454 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules Hip or Knee replacement with MCC, with CC, and without CC/MCC, respectively), and MS–DRGs 469 and 470 (Major Joint Replacement or Reattachment of Lower Extremity with MCC and without MCC, respectively). The first analysis used data from the 2012 National Inpatient Sample (NIS) from the Agency for Research and Quality (AHRQ). We note that the NIS includes Medicare, Medicaid, and commercial and uninsured claims data. However, the applicant limited its search to Medicare cases only. The applicant searched for all Medicare cases assigned to MS–DRGs 461 and 462 and found 812 and 14,200 cases respectively (for a total of 15,012 cases). The applicant noted that the 15,012 cases assigned to MS–DRGs 461 and 462 also include cases representing hip revision procedures. Therefore, to determine the number of eligible cases reporting bilateral knee revisions assigned to MS–DRGs 461 and 462, based on clinical information,47 the applicant approximated that 4 percent of the cases assigned to MS–DRGs 461 and 462 represent Medicare beneficiaries who may be eligible for the VKS for a bilateral knee revision procedure. As a result, the applicant focused its analysis on 32 cases assigned to MS–DRG 461 (812 cases * .04), and 568 cases assigned to MS–DRG 462 (14,200 cases * .04). We are concerned that the statistical data obtained from clinical information that the applicant used to determine the percentage of cases representing bilateral knee revisions still includes cases representing hip revision procedures. Specifically, the applicant did not uniquely identify cases representing bilateral knee revisions and only produced a percentage of all cases that still includes cases for hip revision procedures. According to the applicant, eligible cases for the VKS technology include cases representing knee revision procedures that also map to MS–DRGs 466 through 468 (which represent degrees of severity calculated for each MS–DRG). To determine the number of eligible cases reporting knee revision procedures assigned to MS–DRGs 466 through 468, the applicant first searched the NIS database for the total number of Medicare cases assigned to these MS– DRGs. This resulted in a total of 54,105 cases. The applicant noted that MS– DRGs 466 through 468 also include cases for hip and knee revision 47 Memtsoudis SG, Valle AGD, Besculides MC, Gaber, Sculco TP.: In-hospital complications and mortality of unilateral, bilateral, and revision TKA. 2008, Clin Orthop Relat Res, 466:2617–2627. VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 procedures. Therefore, to determine the number of cases representing knee revision procedures in each of these three MS–DRGs, the applicant first divided the number of Medicare cases for each MS–DRG (5,195 for MS–DRG 466, 28,650 for MS–DRG 467, and 20,260 for MS–DRG 468) by the total number of Medicare cases assigned to MS–DRGs 466, 467, and 468 (54,105). The applicant then multiplied the percentage for each MS–DRG (9.6 percent for MS–DRG 466, 52.9 percent for MS–DRG 467, and 37.4 percent for MS–DRG 468) by the total amount of cases assigned to each MS–DRG. Based on this calculation, the applicant approximated the following number of cases representing knee revision procedures assigned to each of these three MS–DRGs: 3,054 cases in MS– DRG 466; 16,842 in MS–DRG 467; and 11,910 in MS–DRG 468. We are concerned that the methodology the applicant used to determine the percentage of cases representing knee revision procedures still includes cases representing hip revision procedures. Specifically, in its methodology, the applicant did not use any source of statistical relevance to isolate cases representing knee revision procedures. Rather, the applicant used the percentage of Medicare cases assigned to each MS–DRG of the overall total cases for the three MS–DRGs, which includes knee and hip revisions, and multiplied by this percentage to further reduce the total number of cases. We do not believe that this further reduction to the total number of Medicare cases has sufficiently isolated cases representing knee revision procedures. According to the applicant, eligible cases for the VKS technology also include TKA procedures that map to MS–DRGs 469 and 470. To determine the number of eligible cases reporting TKA procedures assigned to MS–DRGs 469 and 470, the applicant first searched the NIS database for the total number of Medicare cases assigned to these MS– DRGs. This resulted in 35,740 cases in MS–DRG 469 and 547,955 cases in MS– DRG 470. The applicant noted that MS– DRGs 469 and 470 also include cases representing hip replacement and other joint replacement procedures. Therefore, in order to determine the number of TKA procedures within these MS–DRGs, the applicant searched the NIS database for cases reporting ICD–9– CM procedure codes that typically map to these MS–DRGs. The applicant first searched for cases representing TKA across all MS–DRGs that reported ICD– 9–CM procedure code 81.54 (Total knee replacement) and found 336,050 cases. PO 00000 Frm 00132 Fmt 4701 Sfmt 4702 The applicant then searched the NIS database for cases representing hip and other joint replacement procedures across all MS–DRGs that reported ICD– 9–CM procedure codes 81.51 (Total hip replacement), 81.52 (Partial hip replacement), 81.56 (Total ankle replacement), 81.57 (Replacement of joint of foot and toe), and 81.59 (Revision of joint replacement of lower extremity, not elsewhere classified) and found 238,050 cases. This resulted in a total of 574,100 cases representing knee, hip, and other joint replacement procedures. The applicant then divided the number of cases representing TKA procedures by the total number of cases (336,050/574,100) and determined that 58.5 percent of all cases assigned to MS–DRGs 469 and 470 are related to TKA procedures. The applicant then multiplied the percent of cases representing TKA procedures (58.5 percent) by the number of cases assigned to MS–DRGs 469 and 470, which resulted in 20,920 cases in MS– DRG 469 (35,740 * .585) and 320,746 cases in MS–DRG 470 (547,955 * .585). We are concerned that the methodology the applicant used to determine the percentage of cases representing TKA procedures still includes cases representing hip and other joint replacement procedures. Specifically, the applicant did not uniquely identify cases representing TKA procedures and only produced a percentage of all cases, which still includes cases representing hip and other joint replacement procedures. Based on the analysis above, the applicant maintained that the total number of cases across MS–DRGs 461 and 462 and MS–DRGs 466 through 470 was 374,071. The applicant determined an average case-weighted charge per case of $57,341. The applicant then determined that it was necessary to remove charges related to the other computer-assisted devices/technologies used during these procedures and charges for operating room time because procedures involving the VKS do not require operating room time, and the charges for the VKS technology would inevitably be different. Therefore, the applicant removed approximately $146 from the average case-weighted charge per care for cases assigned to MS–DRGs 461 and 462, and $73 from the average case-weighted charge per case for cases assigned to MS–DRGs 466 through 470. The applicant noted that the $146 in charges removed from the average caseweighted charges per case for cases assigned to MS–DRGs 461 and 462 was slightly higher than the charges removed from cases assigned to MS– E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules DRGs 466 through 470 because these charges were for bilateral procedures which require additional operating room time. Data from the NIS database is only available on a national level and not on a hospital-specific level. Therefore, in order to standardize the charges per case, the applicant used the FY 2012 IPPS Impact File and the mean value of all relevant standardization factors to standardize the charges per case. We are concerned that the analysis provided by the applicant did not use hospitalspecific data and, therefore, the standardization process may be inaccurate because of the use of mean factors rather than hospital-specific factors. By using mean factors rather than hospital-specific factors, we believe that the standardization performed by the applicant does not sufficiently take into account hospital variations. The applicant then inflated the charges using an inflation factor of 10.4227 percent based on the inflation factor in the FY 2015 IPPS/LTCH PPS final rule (79 FR 50379), and added the charges related to the VKS technology to the adjusted average case-weighted standardized charge per case. This resulted in a final inflated average caseweighted standardized charge per case of $68,121. Using the FY 2015 IPPS Table 10 thresholds, the applicant determined that average case-weighted threshold amount for MS–DRGs 461 and 462 and MS–DRGs 466 through 470 is $57,341. Because the final inflated average case-weighted standardized charge per case for the applicable MS– DRGs exceeds the average case-weighted threshold amount, the applicant maintained that the technology meets the cost criterion. The applicant’s second analysis used data from the 2013 American Hospital Discharge Data (AHD) based on 57 randomly selected hospitals. The applicant searched the data and did not find any cases assigned to MS–DRG 461. The applicant noted that it used a value of 10 cases for its analysis of cases assigned to MS–DRG 461 because data reflecting a zero value indicates that the hospital performed less than 10 procedures. The applicant found 533 cases assigned to MS–DRG 462. To determine the number of cases representing bilateral knee revision procedures in MS–DRG 462, similar to the first analysis, the applicant multiplied the total number of cases assigned to MS–DRG 462 by 4 percent, which resulted in 21 cases. Similar to our statement about the first analysis, we are concerned that the applicant did not uniquely identify cases representing VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 bilateral knee revision procedures and only produced a percentage of all cases, which still includes cases representing hip revision procedures. To determine the number of eligible cases reporting knee revision procedures assigned to MS–DRGs 466 through 468, the applicant first searched the AHD database for the total number of cases assigned to these MS–DRGs. This resulted in a total of 2,969 cases. Because these MS–DRGs include cases representing hip and knee revision procedures, to determine the number of cases representing knee revision procedures in each of these three MS– DRGs, the applicant first divided the number of cases for each MS–DRG (122 for MS–DRG 466; 1,746 for MS–DRG 467; and 1,101 for MS–DRG 468) by the total number of cases in MS–DRGs 466 through 468 (2,969). The applicant then multiplied the percentage for each MS– DRG (4.1 percent for MS–DRG 466; 58.8 percent for MS–DRG 467; and 37.1 percent for MS–DRG 468) by the total number of cases in each MS–DRG. Based on this calculation, the applicant approximated the following number of cases representing knee revision procedures in each of these three MS– DRGs: 1,307 cases in MS–DRG 466; 18,704 in MS–DRG 467; and 11,794 in MS–DRG 468. Similar to our concerns about the first analysis, we are concerned that the methodology the applicant used to determine the percentage of cases of knee revision procedures still includes cases representing hip revision procedures. Specifically, in its methodology, the applicant did not use any source of statistical relevance to isolate cases representing knee revision procedures. The applicant simply used the percentage of Medicare cases for each MS–DRG of the overall total cases for the three MS–DRGs, which include knee and hip revision procedures, and multiplied by this percentage to further reduce the number of cases. We do not believe that this further reduction to the total number of Medicare cases has isolated cases representing knee revision procedures. The applicant used the same methodology from the first analysis to determine the number of eligible cases representing TKA procedures assigned to MS–DRGs 469 and 470. The applicant searched the AHD database and found 1,217 cases assigned to MS–DRG 469 and 24,620 cases assigned to MS–DRG 470. To determine the number of cases representing TKA procedures within these MS–DRGs, the applicant multiplied the total number of cases within these MS–DRGs by the percentage of 58.5 percent from the NIS PO 00000 Frm 00133 Fmt 4701 Sfmt 4702 24455 database, which represents the percentage of knee replacement procedure cases among the total number of cases representing knee, hip and joint replacement procedures. This resulted in 712 cases in MS–DRG 469 (1,217 * .585) and 14,411 cases in MS–DRG 470 (24,620 * .585). Similar to our concerns expressed earlier, we are concerned that the methodology the applicant used to determine the percentage of cases representing TKA procedures still includes cases representing hip replacement and other joint replacement procedures. Specifically, the applicant did not uniquely identify cases representing TKA procedures and only produced a percentage of all cases, which still includes cases representing hip and other joint replacement procedures. Based on this analysis, the applicant maintained that the total number of cases across MS–DRGs 461 and 462 and MS–DRGs 466 and 470 was 46,960. The applicant determined an average caseweighted charge per case of $80,702. For the rest of the analysis, the applicant followed the same methodology as the first analysis. The applicant removed $146 from the average case-weighed charge per case for cases assigned to MS–DRGs 461 and 462 and $73 from the average case-weighted charge per case for cases assigned to MS–DRGs 466 through 470 for charges related to other computer-assisted devices/technologies used during these procedures and additional charges for the use of the operating room. Similar to the first analysis, the applicant used the FY 2012 IPPS impact file and the mean value of all relevant standardization factors from all hospitals to standardize the charges per case. Similar to above, we are concerned that the analysis provided by the applicant did not use hospital-specific data and, therefore, the standardization process may be inaccurate because of the use of mean factors rather than hospital-specific factors. By using mean factors rather than hospital-specific factors, the standardization performed by the applicant does not sufficiently take into account hospital variations. The applicant then inflated the charges using an inflation factor of 10.4227 percent based on the inflation factor in the FY 2015 IPPS/LTCH PPS final rule (79 FR 50379), and added the charges related to the VKS technology to the adjusted average case-weighted standardized charge per case. This resulted in a final inflated average caseweighted standardized charge per case of $90,515. Using the FY 2015 IPPS Table 10 thresholds, the applicant determined that the average case- E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 24456 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules weighted threshold amount for MS– DRGs 461 and 462 and MS–DRGs 466 through 470 is $80,699. Because the final inflated average case-weighted standardized charge per case exceeded the average case-weighted threshold amount for the applicable MS–DRGs, the applicant maintained that the VKS technology meets the cost criterion. The applicant’s third analysis used data from the FY 2015 CMS Before Outliers Removed (BOR) file. The BOR file contained 469 cases in MS–DRG 461 and 9,396 cases in MS–DRG 462. To determine the number of cases representing bilateral knee revision procedures assigned to MS–DRGs 461 and 462, similar to the first analysis, the applicant used an assumption of 4 percent, which resulted in 19 cases in MS–DRG 461 and 376 cases in MS–DRG 462. Similar to our concerns stated earlier, we are concerned that the applicant did not uniquely identify cases representing bilateral knee revision procedures and only produced a percentage of all cases, which still includes cases representing hip revision procedures. To determine the number of eligible cases reporting knee revision procedures assigned to MS–DRGs 466 through 468, the applicant again analyzed the BOR file which contained a total of 44,420 cases. Similar to first two analyses, because these MS–DRGs include cases representing hip and knee revision procedures, to determine the number of cases representing knee revision procedures in each of these three MS–DRGs, the applicant first divided the number of cases for each MS–DRG (4,202 for MS–DRG 466; 23,390 for MS–DRG 467; and 16,828 for MS–DRG 468) by the total number of cases in MS–DRGs 466 through 468 (44,420). The applicant then multiplied the percentage for each MS–DRG (9.5 percent for MS–DRG 466; 52.7 percent for MS–DRG 467; and 37.9 percent for MS–DRG 468) by the total number of cases in each MS–DRG. Based on this calculation, the applicant approximated the following number of cases representing knee revision procedures in each of these three MS–DRGs: 3,009 cases in MS–DRG 466; 16,747 in MS– DRG 467; and 12,049 in MS–DRG 468. Similar to our concerns stated earlier, we are concerned that the methodology the applicant used to determine the percentage of cases representing knee revision procedures still includes cases representing hip revision procedures. Specifically, in its methodology, the applicant did not use any source of statistical relevance to isolate cases representing knee revision procedures. Rather, the applicant used the VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 percentage of Medicare cases for each MS–DRG of the overall total number of cases for the three MS–DRGs, which includes cases representing knee and hip revision procedures, and multiplied by this percentage to further reduce the number of cases. We do not believe that this further reduction to the total number of Medicare cases has isolated cases representing knee revision procedures. The applicant used the same methodology from the first analysis to determine the number of eligible cases reporting TKA procedures assigned to MS–DRGs 469 and 470. The BOR file contained 27,737 cases in MS–DRG 469 and 437,649 cases in MS–DRG 470. To determine the number of cases representing TKA procedures within these MS–DRGs, the applicant multiplied the total number of cases within these MS–DRGs by the percentage of 58.5 percent obtained from the NIS database, which represents the percentage of knee replacement cases among the total number of cases representing knee, hip, and joint replacement procedures. This resulted in 16,236 cases in MS–DRG 469 (27,737 * .585) and 256,178 cases in MS–DRG 470 (437,649 * .585). Similar to our concerns stated earlier, we are concerned that the methodology the applicant used to determine the percentage of cases representing TKA procedures still includes cases representing hip and other joint replacement procedures. Specifically, the applicant did not uniquely identify cases representing TKA procedures and only produced a percentage of all cases, which still includes cases representing hip and other joint revision procedures. Based on this analysis, the applicant maintained that the total number of cases across MS–DRGs 461 and 462 and MS–DRGs 466 through 470 was 304,614. The applicant determined an average case-weighted charge per case of $56,282. For the rest of the analysis, the applicant followed the same methodology as the first analysis. The applicant then removed $146 from the average case-weighted charge per case for cases assigned to MS–DRGs 461 and 462 and $73 from the average caseweighted charge per case for cases assigned to MS–DRGs 466–470 for charges related to other computerassisted devices/technologies used during these procedures and additional charges for the use of the operating room. Similar to the first analysis, the applicant used the FY 2012 IPPS Impact File and the mean value of all relevant standardization factors from all hospitals to standardize the charges per PO 00000 Frm 00134 Fmt 4701 Sfmt 4702 case. Similar to our concerns stated earlier, we are concerned that the analysis provided by the applicant did not use hospital-specific data and, therefore, the standardization process may be inaccurate because of the use of mean factors rather than hospitalspecific factors. By using mean factors rather than hospital-specific factors, we believe that the standardization performed by the applicant does not sufficiently take into account hospital variations. The applicant then inflated the charges using an inflation factor of 10.4227 percent based on the inflation factor in the FY 2015 IPPS/LTCH PPS final rule (79 FR 50379), and added the charges related to the VKS technology to the adjusted average case-weighted standardized charge per case. This resulted in a final inflated average caseweighted standardized charge per case of $66,382. Using the FY 2015 IPPS Table 10 thresholds, the applicant determined that the average caseweighted threshold amount for MS– DRGs 461 and 462 and MS–DRGs 466 through 470 is $64,280. Because the final inflated average case-weighted standardized charge per case exceeds the average case-weighted threshold amount for the applicable MS–DRGs, the applicant maintained that the VKS technology meets the cost criterion. Based on the information provided by the applicant, combined with the weight of our concerns, we are unable to determine if and how the VKS technology meets the cost criterion. We are inviting public comments on whether or not the VKS technology meets the cost criterion, specifically with regard to the concerns raised. With regard to substantial clinical improvement, the applicant maintained that the VKS technology represents a substantial clinical improvement. The applicant stated that the device offers a treatment option for a patient population unresponsive to, or ineligible for, currently available treatments. The applicant explained that the use of the VKS technology has improved patient outcomes, including rapid recovery of patients diagnosed with comorbidities, the early return to normal activities, and increased levels of activity and functionality. The applicant noted that patients treated using the VKS technology during TKA procedures did not experience readmission within 30 days, nor was it necessary for the treating physician (the surgeon) to complete a problem focused medical evaluation during the patient’s recovery. The applicant further noted that patients having a more favorable immediate outcome with a stable TKA E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules were shown to return to normal function more rapidly than patients with unbalanced knees. Therefore, the applicant stated that patients with complex medical conditions would be able to respond to the early return of normal daily living. The applicant also believed that the device offers the ability to diagnose a medical condition for a patient population experiencing medical conditions that are currently undetectable, or offers the ability to diagnose a medical condition earlier than that which is capable using currently available technologies. The applicant explained that the VKS technology provides an improved evaluation/diagnosis compared to an unbalanced TKA implant. Specifically, the applicant stated that the device enables the surgeon to obtain intraoperative measures enabling the surgeon to improve upon the placement of the TKA tibial and femoral components. Additionally, intraoperatively the device leads to an immediate diagnosis of an implant that can now be accurately positioned due to informed fine tissue dissection. The applicant stated that the intraoperative technique has been demonstrated to result in increased implant stability and functional congruence. The applicant cited the following examples of outcomes that have been frequently documented and evaluated within clinical studies of medical devices: • Intended to address the leading causes of early implant failure in TKA: Instability, malrotation and malalignment;48 • Dynamic intercompartmental load data and Kinetic Tracking enables evidence based soft tissue releases to improve stability through full ROM;49 • Provides intraoperative feedback on tibial–femoral component rotation, position of femoral Contact Points and femoral roll-back to facilitate optimal component position • Enables reproducible, teachable surgical technique through quantifying surgeon ‘‘feel’’; and • Captures intraoperative data for inclusion in patient EMR, registries or comparative effectiveness studies. The applicant stated that use of the device significantly improves clinical outcomes for a patient population experiencing these types of medical procedures when compared to currently available treatments. The applicant 48 Rodriguez-Merchan EC.: Instability Following Total Knee Arthroplasty. HSSJ 2011; 7:273–278. 49 Roche MW, Elson LC, Anderson CR.: A Novel Technique Using Sensor-Based Technology to Evaluate Tibial Tray Rotation. Orthopedics. 2014 (In Press). VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 explained that extensive research and development has resulted in the VKS technology demonstrating improved patient outcomes in multi-center studies. The applicant further explained that the VKS technology has intraoperatively provided a unique opportunity to observe the short-term clinical outcomes of patients with a quantifiably balanced knee versus those who have quantifiably unbalanced knees. According to the applicant, in a multi-center study, the use of the VKS technology has been shown to reduce post-operative pain and improve activity and patient satisfaction scores with statistical significance. Additionally, the applicant stated that 97 percent of patients whose knees were balanced using the VKS technology reported that they were ‘‘satisfied’’ to ‘‘very satisfied’’ at 1-year post-operative compared to 81 percent patient satisfaction after a TKA procedure without the use of the VKS technology. The applicant stated that the VKS technology provided a 16-percent improvement in patient satisfaction for balanced knees; the first significantly notable increase of patient-reported satisfaction in over 30 years.50 According to the applicant, the use of the VKS technology avoided early implant failure. The applicant explained that considering the objective to ameliorate the present risks of revision in TKA procedures, the VKS technology has been advanced to address the need for improved knee balance through fine tissue dissection using information from the VKS technology intelligent tibial trial. While not disturbing the surgical flow of TKA procedures, the applicant stated that the VKS technology provides the surgeon with data on the dynamic intercompartmental load, and kinetic tracking enables evidence-based soft tissue releases to improve stability through full ROM.51 The applicant noted that the results of multi-center studies, using the VKS technology intraoperatively, have provided an opportunity to observe the short-term clinical outcomes of patients with a quantifiably balanced knee versus those who have quantifiably unbalanced knees. The applicant further stated that the VKS technology provides intraoperative information on tibial–femoral component rotation, position of femoral 50 Gustke KA, et al.: Increased satisfaction after total knee replacement using sensor-guided technology. Bone Joint J 2014;96–B:1333–8. 51 Gustke, Golladay, et al.: A New Method for Defining Balance: Promising Short-Term Clinical Outcomes of Sensor-Guided TKA. The Journal of Arthroplasty 25 November 2013 (Article in Press DOI: 10.1016/j.arth.2013.10.020) PO 00000 Frm 00135 Fmt 4701 Sfmt 4702 24457 contact points and femoral roll-back to facilitate optimal component position. One clinical study 52 reported 170 primary TKA procedures where the VKS technology corrected what would have resulted in unbalanced and malrotated implants in 53 percent of the patients. The applicant noted that when referencing the tibial tubercle to maximize tibiofemoral congruency, 53 percent of patients exhibited asymmetrical tibiofemoral congruency in extension. The applicant further stated that of those patients, 68 percent were shown to have excessive internal rotation of the tibial tray relative to the femur, while 32 percent exhibited excessive external rotation. Additionally, the average tibiofemoral incongruency deviated from a neutral position by 6°, ranging from 0.5° to 19.2. The applicant stated that when comparing the VKS with the convention of using the tibial tubercle to maximize tibiofemoral congruency to confirm the final rotation of the tibial tray, the VKS technology provided superior information. The applicant added that data from using the tibial tubercle to maximize tibiofemoral congruency to confirm the final rotation of the tibial tray are highly variable and inconsistent for confirming the final rotation of the tibial tray. The applicant stated that the VKS technology has demonstrated and resulted in a ‘‘balanced knee’’ after TKA procedures with 6 month and 1 year outcome scores showing a significant improvement over conventional or computer-assisted TKA procedures. According to the applicant, by not disrupting the surgical flow the VKS technology has been viewed by surgeons to provide information enabling them to improve upon the balance of the knee, reduce the degree of rotation and only dissect the fine tissue as needed sparing the release of the ligaments. The applicant further stated that the VKS technology has been shown to enable reproducible, teachable surgical technique through quantifying surgeon ‘‘feel.’’ The applicant provided patient outcomes at 6 months and believed that this demonstrated a significant improvement for the ‘‘balanced knee’’ TKA procedures using the VKS technology. According to the applicant, multivariate binary logistic regression analyses were performed for both Knee Society Scores (KSS) and Western Ontario and McMaster Universities 52 Roche MW, Elson LC, Anderson CR: A Novel Technique Using Sensor-Based Technology to Evaluate Tibial Tray Rotation. Orthopedics. 2015 (In Press) E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 24458 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules Arthritis Index (WOMAC) scores at 6 months. Variables run in these analyses included: age at surgery, BMI, gender, preoperative ROM, preoperative alignment, change in activity level (preoperative to 6 months), and joint state (balanced versus unbalanced). For KSS and WOMAC, both step-wise and backward multivariate logistic regression analyses were calculated to be best fit models with similar significance (P = 0.001). Ultimately, the step-wise model was used. The applicant stated that the binary model revealed that the variable exhibiting the most significant effect of improvement on KSS and WOMAC scores was balanced joint state (P = 0.001; P = 0.004). The applicant noted that joint state was the most highly significant variable; this demonstrated similar levels of significance throughout all possible combinations of variables included in the model (P = 0.001). The applicant added that joint state was also observed to be the sole significant factor in patient-reported outcome score improvement (P b 0.001). The applicant added that analysis of the data revealed there was also a concurrent significance observed with activity level (P = 0.005). However, the applicant noted that activity level was not significant on its own. The applicant concluded that a balanced joint state results in a higher activity level,53 which would make activity level more of a dependent variable, rather than a predictor. Therefore, to demonstrate activity level, the applicant used a regression analysis and evaluated KSS and WOMAC scores at 6 months, with odds ratios. According to the applicant, odds ratios were calculated based on meaningful clinical improvement in KSS scores, WOMAC scores, and activity levels at 6 months. Additionally, based on literature review, ‘‘meaningful improvement’’ for KSS scores were anything greater than 50 points; WOMAC scores greater than 30 points; and gains in activity level greater than or equal two 2 lifestyle levels (from lowest score to highest: sedentary, semisedentary, light labor, moderate labor, heavy labor). Also, scores from the unbalanced group were used as the reference point. The applicant stated that odds ratio for balanced joint state and improved KSS score was 2.5, with a positive coefficient (95 percent CI). The applicant believed that this suggested a high probability of obtaining 53 Gustke, Golladay, et al.: A New Method for Defining Balance: Promising Short-Term Clinical Outcomes of Sensor-Guided TKA. The Journal of Arthroplasty 25 November 2013 (Article in Press DOI: 10.1016/j.arth.2013.10.020). VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 a meaningful improvement in KSS with a balanced knee joint, over those who do not have a balanced knee. According to the applicant, the odds ratio for balanced joint state and improved WOMAC score was 1.3, with a positive coefficient (95 percent CI). The applicant believed that this suggested a favorable probability that patients with a balanced joint state will achieve a meaningful improvement in WOMAC score, over those that do not have a balanced knee. According to the applicant, the odds ratio for balanced joint state and improved activity level was 1.8, with a positive coefficient (95 percent CI). The applicant believed that this also suggested a favorable probability of meaningful gains in activity level in those with a balanced knee, versus those with an unbalanced knee. The applicant further stated that 1 year clinical trial evidence supports the VKS technology protocol for TKA procedures. According to the applicant, of the 135 patients undergoing sensorguided surgery, 13 percent remained unbalanced (by surgeon discretion). The applicant stated that ‘‘surgeon discretion,’’ in this analysis, indicates that the surgeon recognized and accepted the ‘‘unbalanced’’ intercompartmental load difference as presented by the VKS technology, but felt that the knee was in a clinically acceptable state. Pre-operatively, there was no statistical difference in any outcomes measures between the two cohorts, the averages of which were: total KSS = 105 ± 24.6; total WOMAC = 47 ± 14.8. Additionally, according to the applicant, at 1 year, the average total KSS score of balanced patients exceeded that of unbalanced patients by 23.3 points (P <0.001); 179 ± 17.2 and 156 ± 23.4 for the balanced and unbalanced cohort, respectively. The balanced cohort average score for KSS pain and function, separately, were 96.4 and 82.4 respectively; the unbalanced cohort scored 87.8 and 68.3 points for pain and function. The applicant stated that the disparities between the balanced and unbalanced patients’ pain and function scores were also highly statistically significant (P <0.001, P=0.022). For WOMAC, the applicant noted that that the balanced cohort improved their score by 8 points; 10 ± 11.8 and 18 ± 17 for balanced and unbalanced patients, respectively (WOMAC is scored with an inverse scale; lower scores indicate more improvement). The applicant further stated that while this difference did not prove to be statistically significant by the standards set forth for this analysis (P = 0.085), the authors PO 00000 Frm 00136 Fmt 4701 Sfmt 4702 believed that this is due, in part, to the large standard deviations associated with both cohorts. According to the applicant, the balanced cohort’s average activity level score was 48.6, which corresponds with the light to moderate labor categories (tennis, light jogging, heavy yard work) and the unbalanced patient’s average activity level score was 26.7, which corresponds to the upper limits of the semi-sedentary range (light housework, walking for limited distances). The applicant believed that the difference between the average scores was statistically significant (P = 0.015). The applicant noted that the most notable aspect of every outcome measure collected is that the unbalanced patient scores at 1 year still failed to achieve the level of improvement of the balanced patient scores at 6 months. We have a number of concerns regarding the applicant’s assertions regarding substantial clinical improvement. First, we are concerned that during the trials, after using the device surgeons continued to make manual adjustments to the spacers to set the knee replacement. The applicant maintained that the VKS technology presents better accuracy for the surgeon when making adjustments to the spacers when implanting a knee replacement. However, we are concerned that the evidence does not delineate the degree of any improved outcomes or patient satisfaction associated with use of the VKS technology versus additional manual adjustments made by the surgeon. We also are concerned that most of the clinical evidence is based on patient satisfaction surveys. While the survey data appeared to demonstrate that patient satisfaction improved, we do not believe that the data presented is sufficient to determine if the VKS technology represents a substantial clinical improvement over manual adjustment. Furthermore, the use of historical literature controls might be useful during early clinical development, but there are possible biases and limitations of this research design. Specifically, there could be multiple differences in the preprocedure clinical characteristics of patients with ‘‘unbalanced’’ knees and those with ‘‘balanced’’ knees that could affect outcomes, such as more severe initial disease, more pre-operative misalignment, more obesity, or more comorbidity. These and other potential confounders were not documented or adjusted for in the analyses of outcomes in the literature provided by the applicant. Additionally, as discussed above, the applicant released a first version of the VKS technology in 2011 E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules and advancements were made to the VKS technology that resulted in additional FDA clearances in 2013. The applicant stated in its application that the first version is considered the first technology of its kind and, therefore, we believe that the VKS technology may no longer be considered new. The applicant submitted an application for the advanced version of the VKS technology from 2013. However, the applicant did not present clinical data to distinguish the improvements made to the advanced version from the first version. Therefore, we are unable to determine if the advanced version represents a substantial clinical improvement over existing technologies (that is, the first version of the VKS technology). We are inviting public comments on whether the VKS technology meets the substantial clinical improvement criterion, specifically with regard to our concerns. tkelley on DSK3SPTVN1PROD with PROPOSALS2 i. WATCHMAN® Left Atrial Appendage (LAA) Closure Technology Boston Scientific Corporation submitted an application for new technology add-on payments for FY 2016 for the WATCHMAN® Left Atrial Appendage (LAA) Closure Technology (WATCHMAN® System). (We note that, as discussed in detail later in this section, the applicant submitted an application for new technology add-on payments for FY 2015 for the WATCHMAN® System, but withdrew its application after we issued the FY 2015 IPPS/LTCH PPS proposed rule.) According to the applicant, when a patient has been diagnosed with atrial fibrillation (AF), the left atrium does not expand and contract normally. As a result, the left atrium is not capable of completely emptying itself of blood. Blood may pool, particularly in the part of the left atrium called the left atrial appendage. This pooled blood is prone to clotting, causing formation of a thrombus. If a thrombus breaks off, it is called an embolism (or thromboembolism). An embolism can cause a stroke or other peripheral arterial blockage. The applicant asserted that the WATCHMAN® System device is an implant that acts as a physical barrier, sealing the LAA to prevent thromboemboli from entering into the arterial circulation from the LAA, thereby reducing the risk of stroke and potentially eliminating the need for Warfarin therapy for patients diagnosed with nonvalvular AF who are eligible for Warfarin therapy but for whom the risks of long-term oral anticoagulation outweigh the benefits. VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 With regard to newness criterion, the applicant anticipated FDA premarket approval of the WATCHMAN® System in the first half of 2015. According to the applicant, the WATCHMAN® System is the first LAA closure device that would be approved by the FDA. Therefore, the applicant believed that the technology meets the newness criterion. Effective October 1, 2004 (FY 2005), ICD–9–CM procedure code 37.90 (Insertion of left atrial appendage device) was created to identify and describe procedures using the WATCHMAN® Left Atrial Appendage (LAA) Closure Technology. As stated in section II.G.1.a. of the preamble of this proposed rule, effective October 1, 2015 (FY 2016), the ICD–10 coding system will be implemented. Under the ICD– 10–PCS, procedure code 02L73DK (Occlusion of left atrial appendage with intraluminal device, percutaneous approach) is the comparable translation for ICD–9–CM procedure code 37.90. We are inviting public comments on if, and how, the WATCHMAN® System meets the newness criterion. With regard to the cost criterion, the applicant used the FY 2013 MedPAR file (which contained inpatient hospital claims data for discharges from October 1, 2012 to September 30, 2013) to search for cases reporting ICD–9–CM procedure code 37.90. The applicant provided two analyses. The first analysis includes all claims that reported ICD–9–CM procedure code 37.90, regardless of whether the code indicated a principal procedure that determined the MS–DRG assignment of the case. This analysis identified 507 cases across 29 MS– DRGs. The applicant noted that the MedPAR file contained claims that were returned to the provider that reported charges for actual cases from clinical trials that used the WATCHMAN® System that were well below post-FDA approval pricing. Therefore, the applicant removed the premarket device related charges. The applicant then standardized the charges, applied an inflation factor of 1.10443 based on the 2-year charge inflation factor listed in the FY 2015 IPPS/LTCH PPS final rule (79 FR 50379) and then added post-FDA approval charges for the WATCHMAN® System. Using the anticipated cost of the device after FDA approval and the National Average Implantable Device cost center CCR, the applicant estimated device charges post-FDA approval, combined those with the inflated average case-weighted standardized charges per case, and determined a final inflated average case-weighted standardized charge per case of $150,213. The average case-weighted threshold amount in the FY 2015 IPPS PO 00000 Frm 00137 Fmt 4701 Sfmt 4702 24459 Table 10 for these MS–DRGs was $97,505. Because the final inflated average case-weighted standardized charge per case exceeds the average case-weighted threshold amount of $97,505, the applicant maintained that the WATCHMAN® System meets the cost criterion using this analysis. We are inviting public comments on the whether the WATCHMAN® System meets the cost criterion based on this analysis. In the applicant’s second analysis, cases eligible for the WATCHMAN® System were identified by claims reporting ICD–9–CM procedure code 37.90 assigned to MS–DRGs 250 and 251 (Percutaneous Cardiovascular Procedures without Coronary Artery Stent with MCC and without MCC, respectively). The applicant believed that these are the MS–DRGs to which cases are typically assigned if the WATCHMAN® System is used in the principal procedure performed during the inpatient stay. The applicant applied the trims in the FY 2015 IPPS/ LTCH PPS final rule (79 FR49910 through 49911), which resulted in 369 cases. As with its first analysis, the applicant determined standardized nondevice charges for the applicable cases using claims data from the FY 2013 MedPAR file and applied an inflation factor. The applicant calculated average nondevice charges by subtracting what the applicant believed was the average total implantable device charges (calculated as the sum of the five individual device charge fields in the MedPAR file that constitute the Implantable Device cost center). Similar to its first analysis, the applicant then standardized the charges, applied an inflation factor of 1.10443, subtracted the device charges reported on the MedPAR claims (reflecting costs during the IDE study) and replaced them with the anticipated charges following FDA approval (converting the costs of the device to charges with a CCR of 0.349 based on the national average implantable device CCR from the FY 2015 IPPS/LTCH PPS final rule (79 FR 49914)), combined those with the inflated average case-weighted standardized charges per case, and determined a final inflated average caseweighted standardized charge per case of $117,663. The average case-weighted threshold amount for these MS–DRGs in the FY 2015 IPPS Table 10 was $72,804. Because the final inflated average caseweighted standardized charge per case exceeds the average case-weighted MS– DRG threshold amount of $72,804, the applicant maintained that the WATCHMAN® System meets the cost E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 24460 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules criterion using this analysis. We note that the applicant searched for cases reporting ICD–9–CM procedure code 37.90. In section II.G.3.b. of the preamble of this proposed rule, we present a proposal regarding cardiac ablation and other specified cardiovascular procedures. Specifically, we are proposing to assign the procedures performed within the heart chambers using intracardiac techniques, including those identified by ICD–9–CM procedure code 37.90, to two new proposed MS–DRGs: Proposed MS–DRG 273 (Percutaneous Intracardiac Procedures with MCC) and proposed MS–DRG 274 (Percutaneous Intracardiac Procedures without MCC). We believe that this could have implications for determining whether the applicant meets the cost criterion. There have been instances in the past where the coding associated with a new technology application is included in a proposal to change one or more MS– DRGs. For example, in the FY 2013 IPPS/LTCH PPS final rule, we describe the cost analysis for the Zenith® Fenestrated Abdominal Aortic Aneurysm Endovascular Graft which was identified by ICD–9–CM procedure code 39.78. In that same rule, we finalized a change to the assignment of that procedure code, reassigning it from MS–DRGs 252, 253, and 254 to MS– DRGs 237 and 238. Because of that change, we determined that, for FY 2013, in order for the Zenith® Fenestrated Abdominal Aortic Aneurysm Endovascular Graft to meet the cost criteria, it must demonstrate that the average case-weighted standardized charge per case exceeds the thresholds for MS–DRGs 237 and 238 (77 FR 55360). We note that in that example, MS–DRGs 237 and 238 existed previously; therefore, thresholds that were 75 percent of one standard deviation beyond the geometric mean standardized charge for these DRGs were available to the public in Table 10 at the time the application was submitted. In this case, if MS–DRGs 273 and 274 were to be finalized for FY 2016, we recognize that thresholds that are 75 percent of one standard deviation beyond the geometric mean standardized charge would not have been available at the time the application was submitted. However, we believe that it could be appropriate for the applicant to demonstrate that the average case-weighted standardized charge per case exceeds these thresholds for MS–DRGs 273 and 274. Accordingly, we intend to calculate supplemental threshold values using the data used to generate the FY 2015 IPPS/LTCH PPS VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 Table 10 and reassign the procedure codes in accordance with the proposals outlined in section II.G.3.b. of the preamble of this proposed rule. We intend to make these supplemental threshold values available for public consideration on our Web site at: https:// www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/ AcuteInpatientPPS/newtech.html. We are inviting public comments on whether considering these supplemental threshold values as part of the cost criterion evaluation for this application is appropriate and also on how to address similar future situations in a broader policy context should they occur. We also are inviting public comments on the whether the WATCHMAN® System meets the cost criterion based on the applicant’s analysis. Regarding the substantial clinical improvement criterion, we note that the applicant applied for new technology add-on payments for FY 2015 (as discussed in the FY 2015 IPPS/LTCH PPS proposed rule (79 FR 28043 through 28045)). However, prior to the publication of the FY 2015 IPPS/LTCH PPS final rule, the applicant withdrew its application. Before the withdrawal of the application, CMS stated its concerns with the application in the FY 2015 IPPS/LTCH PPS proposed rule. The applicant included responses to CMS’ previous concerns with the FY 2015 application in its FY 2016 application. Therefore, we are addressing the applicant’s responses to the previous concerns specified in the FY 2015 IPPS/ LTCH PPS proposed rule as well as our observations on the current FY 2016 application in this FY 2016 IPPS/LTCH PPS proposed rule. The applicant asserted that the WATCHMAN® System, a system that reduces the risk of thromboembolic stroke in patients diagnosed with highrisk nonvalvular AF who are eligible for Warfarin therapy, but in whom the potential risks of Warfarin therapy outweigh the potential benefits, meets the substantial clinical improvement criterion because the WATCHMAN® System is superior to currently available treatments. The applicant claimed that the WATCHMAN® System is ideal for patients diagnosed with a prior hemorrhagic stroke while on Warfarin therapy, patients not adherent to Warfarin therapy, patients with difficulty achieving a therapeutic international normalized ratio (INR), and patients with an increased risk or history of falls. The applicant acknowledged that anticoagulation using Warfarin therapy or one of the novel oral anticoagulation agents PO 00000 Frm 00138 Fmt 4701 Sfmt 4702 (NOACs), such as dabigatran, rivaroxaban, or apixaban, is effective for preventing thromboembolism in patients who can tolerate such medication over the long term. However, these medications are associated with certain risks. The applicant stated that the most used and studied agent, Warfarin, requires dietary restrictions, has a high-risk of drug interactions, genetic variability in doseresponse, and the need for frequent monitoring. According to the applicant, the average patient diagnosed with AF and treated with Warfarin therapy achieves a therapeutic INR for approximately one-half of the treatment time. The applicant further stated that these NOACs also have nonadherence risks, high discontinuation rates (up to 20 percent within 2 years), are difficult to monitor effectiveness, and in some cases have no readily available reversal strategy. In support of its assertion that the WATCHMAN® System is a substantial improvement, the applicant submitted data from two pivotal studies (PROTECT AF and the WATCHMAN® Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation Versus Long-Term Warfarin Therapy (PREVAIL)). The data included results of a meta-analysis of the PROTECT AF and PREVAIL studies, an imputed placebo analysis, and a post hoc analysis of the bleeding risks associated with the WATCHMAN® System. According to the applicant, the clinical evidence from these trials and analyses establish the following: implantation of the WATCHMAN® System is safe; the WATCHMAN® System is superior to Warfarin when evaluated against a composite endpoint of all stroke, systemic embolism, and cardiovascular unexplained death in long-term followup; the WATCHMAN® System provides a greater reduction in major bleeding events after the conclusion of post procedure anti-thrombotic medication; and the WATCHMAN® System reduces the incidence of ischemic stroke when compared to patients diagnosed with AF who are not treated with Warfarin or other anticoagulation medication. We note that, unlike in the FY 2015 application, the applicant did not include data from the ASAP study. In the FY 2015 IPPS/LTCH PPS proposed rule (79 FR 28043 through 28045), we expressed concerns that data from the ASAP study suggested that the device did not prevent strokes and was insufficient to demonstrate efficacy in the secondary patient population (patients diagnosed with AF who were ineligible for oral anticoagulation). We specifically stated that the ASAP E:\FR\FM\30APP2.SGM 30APP2 24461 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules Registry (5) enrolled 150 patients, at one of four centers, that had a contraindication to even short-term anticoagulation, mostly a history of prior bleeding, and there was no control group. Device implantation led to a serious adverse event in 13 patients (8.7 percent), including one case of device thrombus leading to ischemic stroke. Five other patients had a device-related thrombus that did not lead to stroke (4 of these patients were treated with low molecular weight heparin), resulting in an overall 4.0 percent incidence (6 out of 150) of device-associated thrombus. In the PROTECT AF trial study, 20 of the 473 patients (4.2 percent) had device-associated thrombus, 3 of which led to an ischemic stroke. The rates of device-related thrombus are similar in the two studies (4.0 percent versus 4.2 percent), but the number of patients studied is smaller in the ASAP Registry (5) study compared to the PROTECT AF clinical trial study. In the 14-month follow-up data for the ASAP Registry (5) study, the rate of stroke or systemic embolism was 2.3 percent per year, which was said to be ‘‘lower than expected’’ based on prior data for patients diagnosed with AF who were not treated with warfarin (there was no concurrent control group). The data provided suggested efficacy in this patient population. However, we stated that we were concerned that there was not strong evidence that the device prevents stroke. In the FY 2016 application, the applicant responded that, because the current intended use and indications for the WATCHMAN® System in the United States do not include patients who are ineligible for treatment using Warfarin therapy, the data from the ASAP study are irrelevant to the FY 2016 application. The applicant provided data from an imputed placebo analysis, a post-hoc analysis that compared the observed rate of ischemic strokes in patients treated with the WATCHMAN® System compared to no therapy, in order to address our concern that there was not strong evidence that the device prevented stroke. According to the applicant, in the PROTECT AF trial, 463 patients were randomized to the WATCHMAN® System device and 244 patients to Warfarin therapy. Most patients randomized to the WATCHMAN® System device had it implanted (408 = 88 percent). Over the average 3.8 years of follow-up, more patients in the Warfarin therapy group withdrew (45 versus 15) or were lost to follow-up (11 versus 13) than in the WATCHMAN® System device group, leading to shorter mean follow-up (3.7 versus 3.9 years) in the Warfarin therapy group. The applicant presented data shown in the following table and maintained that the results of the PROTECT study demonstrate primary efficacy and support that the WATCHMAN® System is noninferior and superior at 4 years. TABLE 3—PROTECT PRIMARY EFFICACY SUPPORTS WATCHMAN® NON-INFERIORITY AND SUPERIORITY AT 4 YEARS Patient years 1065 1588 2621 2717 Years of mean follow-up ....... ....... ....... ....... WATCHMAN® System observed rate per 100 patient years 1.5 2.3 3.8 4 Warfarin observed rate per 100 patient years 3 3 2.3 2.2 Posterior probability * Percentage reduction vs. warfarin (percent) 4.9 4.3 3.8 3.7 Non-inferiority (NI) (percent) 38 29 40 39 Superiority (S) (percent) >99.9 >99.9 >99 >99.9 90.00 84.60 96 95.40 NI. NI. NI and S. NI and S. tkelley on DSK3SPTVN1PROD with PROPOSALS2 * For Bayesian analysis, a posterior probability of 97.5 percent represents non-inferiority; ≥95 percent represents superiority. In the FY 2015 IPPS/LTCH PPS proposed rule, we expressed concern that the evidence presented by the applicant demonstrating superiority compared to Warfarin therapy was insufficient. We expressed concern that the PROTECT AF trial was not designed to demonstrate superiority, and instead was designed to demonstrate noninferiority. We also expressed concern that the PREVAIL trial endpoint was not significantly improved in the conventional hypothesis testing statistical analysis at any time point. We stated that the longer term data showed improved efficacy and safety, but still remain sparse. In the FY 2016 application, the applicant stated that, under a Bayesian analysis, the distributions of the posterior probabilities are not symmetrical. According to the applicant, posterior probabilities represent the appropriate way to determine statistical significance in Bayesian methodology. As predefined in the PROTECT AF trial, a posterior probability for noninferiority of equal to or more than 97.5 percent, and a VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 prespecified level of at least 95 percent to support superiority were the criteria for statistical testing. According to the applicant, in both cases (noninferiority and superiority), the criteria were met for long-term follow-up as demonstrated in the results of the PROTECT AF trial. We agree that the Bayesian methodology is a valid method of analysis. However, we were referencing the overall efficacy noninferiority in the PREVAIL trial. We continue to be concerned that the data results from the PROTECT AF study are insufficient to show superiority of the WATCHMAN® System over Warfarin therapy. We note that the study was unblinded with a noninferiority design. We believe that the reduction in cardiovascular mortality shown in the results from the PROTECT AF study was unexpected and not well explained. Among the 57 patients in the WATCHMAN® System group who died, only 53 patient cases were assigned a cause of death and only 5 of the 9 ‘‘unexplained/other deaths’’ were included in the primary endpoint, although the protocol established that PO 00000 Frm 00139 Fmt 4701 Sfmt 4702 unexplained deaths were to be considered as cardiovascular mortalities. The total number of ‘‘cardiovascular or unexplained deaths’’ would have been 21, not 17. In the Warfarin therapy group, there was 1 ‘‘unexplained/other’’ death that should have been included in the primary endpoint, resulting in a total of 23, not 22. We acknowledge that it may be difficult to calculate the impact of these additional events as the intention-totreat analysis of the primary endpoint. However, we are concerned that the inclusion of the additional deaths could have made the posterior probabilities for the device less favorable. Based on the data at face value, it appears that the WATCHMAN® System does not demonstrate statistically significant superiority over treatment with Warfarin therapy until 3.8 years has elapsed and the patient has been administered 6 months of oral anticoagulation and been exposed to the risk of the device-related complications. We are concerned that the applicant has E:\FR\FM\30APP2.SGM 30APP2 24462 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules not demonstrated substantially improved clinical outcomes. In the prospective randomized evaluation of the PREVAIL study, the goal was to assess the safety and efficacy of LAA occlusion for stroke prevention in patients diagnosed with NVAF compared to long-term Warfarin therapy. The PREVAIL study was a confirmatory randomized trial designed to further assess the efficacy and safety of the WATCHMAN® System device. Patient selection and study design were similar to the PROTECT AF study. Two efficacy and 1 safety coprimary endpoints were assessed at 18 months. The rate of the first coprimary efficacy endpoint overall efficacy (composite of stroke, systemic embolism [SE], and cardiovascular/unexplained death) was 0.064 in the WATCHMAN® System device group versus 0.063 in the control group (rate ratio 1.07 [95 percent credible interval (CrI) 0.57 to 1.89]) and did not achieve the prespecified criteria of noninferiority (upper boundary of 95 percent CrI 1.75). The rate for the second coprimary efficacy endpoint (stroke or SE >7 days’ postrandomization) was 0.0253 versus 0.0200 (risk difference 0.0053 [95 percent CrI –0.0190 to 0.0273]), which achieved noninferiority. Early safety events were significantly lower than the results of the PROTECT AF study, which satisfies the prespecified safety performance goal. The PREVAIL study was designed to demonstrate noninferiority with wide efficacy margins. However, as previously stated, we are concerned that the results of the study did not show the overall efficacy of the technology to be noninferior. The applicant submitted data from a patient-level meta-analysis that combined the data from the PROTECT AF study with the data from the PREVAIL study. According to the applicant, this analysis supports the efficacy of the WATCHMAN® System and shows that the device was performing as expected compared to the Warfarin therapy control arm. The datasets were combined and weighted. According to the applicant, multiple outcomes of interest were examined, starting with the primary efficacy endpoint and then looking at individual outcomes: All stroke (ischemic and hemorrhagic) and associated disability; systemic embolism; cardiovascular/ unexplained death; and major bleeding. The overall incidence of all strokes (ischemic and hemorrhagic) was not statistically different in the WATCHMAN® System arm and the Warfarin therapy arm. However, the applicant stated that there were statistical differences identified when it analyzed the stroke subtypes. The applicant indicated that, initially, there were more ischemic strokes in the WATCHMAN® System arm. However, after accounting for early procedural complications, including strokes (within 7 days post procedure) in the PROTECT AF study, the difference for ischemic stroke between the two arms fell below statistical significance (p = 0.21). According to the applicant, there were significantly more hemorrhagic strokes and cardiovascular deaths in the Warfarin therapy arm compared to the WATCHMAN® System arm, showing a 78 percent and 52 percent reduction in those events respectively (p = 0.004 and p = 0.006). To better assess the clinical impact of the different subtypes of strokes on patients, the applicant also performed statistical tests on disabilities resulting from stroke. The applicant indicated that, using a validated stroke severity assessment tool (Modified Rankin score), analyses show that there were significantly less disabling strokes with the WATCHMAN® System than Warfarin therapy. The applicant believed that this represents a substantial clinical improvement for the WATCHMAN® System device. The applicant conducted an imputed placebo analysis to assess the benefit that untreated patients may expect with the WATCHMAN® System device. The applicant contended that many patients who are eligible for Warfarin therapy are not receiving any treatment and, therefore, are left unprotected from stroke. With annual ischemic stroke rates ranging from 5.6 percent to 7.1 percent, the applicant maintained that the WATCHMAN® System device provides a substantive clinical benefit. In order to assess the benefit that untreated patients may be able to expect with the WATCHMAN® System, the sponsor performed the following exploratory analysis. The observed device ischemic strokes rates were compared against the estimated stroke risk of untreated nonvalvular AF patients. A placebo arm was then constructed using ‘‘well-established, validated literature’’ models based on both the CHADS2 and CHA2DS2–VASc scores. The applicant reported that this analysis showed the WATCHMAN® System device reduced stroke in the untreated patient population by 61 to 81 percent. We previously expressed concern that there was a lack of strong evidence demonstrating that the WATCHMAN® System prevents stroke at all. The applicant responded that the imputed placebo analysis cited above addresses this concern. The applicant provided the table below as part of its FY 2016 application to show the relative risk reduction in Ischemic stroke rates using the WATCHMAN® System versus no therapy. TABLE 5—WATCHMAN® SHOWS SIGNIFICANT REDUCTION IN ISCHEMIC STROKES COMPARED TO NO THERAPY Average CHADS (2 footnote on acronym) score WATCHMAN® patients Study tkelley on DSK3SPTVN1PROD with PROPOSALS2 PROTECT AF .......................................................................... PREVAIL-only .......................................................................... CAP .......................................................................................... While the results of this analysis appear to suggest a large reduction in ischemic stroke rates in patients who did not receive any treatment, we continue to have some concerns regarding whether the WATCHMAN® System device prevents strokes. The indication for the treatment of the VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 2.2 2.6 2.5 Observed WATCHMAN® annual ischemic stroke rate (95 percent CI) 1.3 (0.9, 2.0) 2.3 (1.3, 4.0) 1.2 (0.8, 1.8) WATCHMAN® System device is for patients who are eligible for Warfarin therapy as opposed to patients who are ineligible for Warfarin therapy. We are concerned that the results of the imputed placebo analysis are not sufficient to determine whether the WATCHMAN® System reduces the risk PO 00000 Frm 00140 Fmt 4701 Sfmt 4702 Imputed untreated annual event rate 5.6–5.7 6.6–6.7 6.4 Relative risk reduction 77% (64%, 84%) 65% (39%, 80%) 81% (72%, 88%) of stroke in patients who are eligible for Warfarin therapy. The applicant suggested that patients who are subtherapeutic or noncompliant with Warfarin therapy would have the same risk of stroke as patients who do not receive any therapy. However, the applicant but did not offer any evidence E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules that these two groups have the same risk of stroke. The WATCHMAN® System device is intended only for use in patients who are eligible for the anticoagulation, not for patients who have contraindications to oral anticoagulation. Because the device will not be labeled for use in those patients, we believe that an analysis comparing stroke risk of untreated patients to those patients treated with the WATCHMAN® System is of limited value in assessing the technology’s benefit over existing therapy. The applicant asserted that one of the primary goals of mechanical LAA closure is to provide an alternative treatment for patients other than longterm Warfarin therapy and exposure to the associated risk for bleeding. Although the primary efficacy endpoint of the PROTECT AF and PREVAIL studies considered hemorrhagic stroke, it did not encompass other types of major bleeding that may be associated with the use of Warfarin. The applicant indicated that it performed a supplemental analysis to determine the relative risks of all types of bleeding. The applicant divided the follow-up interval into four subsections (7 days, 45 days, 6 months, and 54 months). The applicant compared bleeding events in the WATCHMAN® System group with the Warfarin therapy group and concluded that, after 6 months (and discontinued use of Clopidogrel in the WATCHMAN® System group), the continued use of Warfarin was associated with a 3.4 fold increase in the risk of major bleeding. According to the applicant, the significant reduction in bleeding after the procedural and concomitant medication therapy (6 months) with the cessation of long-term anticoagulants illustrates the substantial clinical benefit of the WATCHMAN® System. However, given the high burden endured (most notably, the higher risk of bleeding occurring in the first 7 days of an inpatient hospital stay) to achieve a reduction in bleeding in the long term, we do not believe that the WATCHMAN® System meets the criteria for substantially improved clinical outcomes. We are inviting public comments on whether this technology meets the substantial clinical improvement criterion, particularly in light of the applicant’s response to our previous concerns and our current concern that there remains insufficient evidence that the WATCHMAN® System substantially improves clinical outcomes in patients diagnosed with nonvalvular AF and who are eligible for Warfarin therapy. We did not receive any public comments in response to the New VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 Technology Town Hall meeting held on February 13, 2015 in regard to the WATCHMAN® System technology. III. Proposed Changes to the Hospital Wage Index for Acute Care Hospitals A. Background 1. Legislative Authority Section 1886(d)(3)(E) of the Act requires that, as part of the methodology for determining prospective payments to hospitals, the Secretary adjust the standardized amounts for area differences in hospital wage levels by a factor (established by the Secretary) reflecting the relative hospital wage level in the geographic area of the hospital compared to the national average hospital wage level. We currently define hospital labor market areas based on the delineations of statistical areas established by the Office of Management and Budget (OMB). A discussion of the proposed FY 2016 hospital wage index based on the statistical areas appears under sections III.A.2. and G. of the preamble of this proposed rule. Section 1886(d)(3)(E) of the Act requires the Secretary to update the wage index annually and to base the update on a survey of wages and wagerelated costs of short-term, acute care hospitals. This provision also requires that any updates or adjustments to the wage index be made in a manner that ensures that aggregate payments to hospitals are not affected by the change in the wage index. The proposed adjustment for FY 2016 is discussed in section II.B. of the Addendum to this proposed rule. As discussed in section III.J. of the preamble of this proposed rule, we also take into account the geographic reclassification of hospitals in accordance with sections 1886(d)(8)(B) and 1886(d)(10) of the Act when calculating IPPS payment amounts. Under section 1886(d)(8)(D) of the Act, the Secretary is required to adjust the standardized amounts so as to ensure that aggregate payments under the IPPS after implementation of the provisions of sections 1886(d)(8)(B), 1886(d)(8)(C), and 1886(d)(10) of the Act are equal to the aggregate prospective payments that would have been made absent these provisions. The proposed budget neutrality adjustment for FY 2016 is discussed in section II.A.4.b. of the Addendum to this proposed rule. Section 1886(d)(3)(E) of the Act also provides for the collection of data every 3 years on the occupational mix of employees for short-term, acute care hospitals participating in the Medicare program, in order to construct an PO 00000 Frm 00141 Fmt 4701 Sfmt 4702 24463 occupational mix adjustment to the wage index. A discussion of the occupational mix adjustment that we are proposing to apply, beginning October 1, 2015 (to the FY 2016 wage index), appears under sections III.E.3. and F. of the preamble of this proposed rule. 2. Core-Based Statistical Areas (CBSAs) for the Proposed Rule The wage index is calculated and assigned to hospitals on the basis of the labor market area in which the hospital is located. Under section 1886(d)(3)(E) of the Act, beginning with FY 2005, we delineate hospital labor market areas based on OMB-established Core-Based Statistical Areas (CBSAs). The current statistical areas (which were implemented beginning with FY 2015) are based on revised OMB delineations issued on February 28, 2013, in OMB Bulletin No. 13–01. OMB Bulletin No. 13–01 established revised delineations for Metropolitan Statistical Areas, Micropolitan Statistical Areas, and Combined Statistical Areas in the United States and Puerto Rico, and provided guidance on the use of the delineations of these statistical areas based on new standards published on June 28, 2010 in the Federal Register (75 FR 37246 through 37252) and the 2010 Census of Population and Housing data (we refer to these revised OMB delineations as the ‘‘new OMB delineations’’ in this proposed rule). A copy of this bulletin may be obtained at https://www.whitehouse.gov/sites/ default/files/omb/bulletins/2013/b-1301.pdf. We refer readers to the FY 2015 IPPS/LTCH PPS final rule (79 FR 49951 through 49963) for a full discussion of our implementation of the new OMB labor market area delineations for the FY 2015 wage index. For FY 2016, we are continuing to use the new OMB delineations that we adopted beginning with FY 2015 to calculate the area wage indexes and the transition periods, which we discuss below. B. Worksheet S–3 Wage Data for the Proposed FY 2016 Wage Index The proposed FY 2016 wage index values are based on the data collected from the Medicare cost reports submitted by hospitals for cost reporting periods beginning in FY 2012 (the FY 2015 wage indexes were based on data from cost reporting periods beginning during FY 2011). 1. Included Categories of Costs The proposed FY 2016 wage index includes the following categories of data associated with costs paid under the IPPS (as well as outpatient costs): E:\FR\FM\30APP2.SGM 30APP2 24464 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules • Salaries and hours from short-term, acute care hospitals (including paid lunch hours and hours associated with military leave and jury duty); • Home office costs and hours; • Certain contract labor costs and hours (which includes direct patient care, certain top management, pharmacy, laboratory, and nonteaching physician Part A services, and certain contract indirect patient care services (as discussed in the FY 2008 final rule with comment period (72 FR 47315 through 47318)); and • Wage-related costs, including pension costs (based on policies adopted in the FY 2012 IPPS/LTCH PPS final rule (76 FR 51586 through 51590)) and other deferred compensation costs. 2. Excluded Categories of Costs Consistent with the wage index methodology for FY 2015, the proposed wage index for FY 2016 also excludes the direct and overhead salaries and hours for services not subject to IPPS payment, such as skilled nursing facility (SNF) services, home health services, costs related to GME (teaching physicians and residents) and certified registered nurse anesthetists (CRNAs), and other subprovider components that are not paid under the IPPS. The proposed FY 2016 wage index also excludes the salaries, hours, and wagerelated costs of hospital-based rural health clinics (RHCs), and Federally qualified health centers (FQHCs) because Medicare pays for these costs outside of the IPPS (68 FR 45395). In addition, salaries, hours, and wagerelated costs of CAHs are excluded from the proposed wage index for the reasons explained in the FY 2004 IPPS final rule (68 FR 45397 through 45398). tkelley on DSK3SPTVN1PROD with PROPOSALS2 3. Use of Wage Index Data by Suppliers and Providers Other Than Acute Care Hospitals Under the IPPS Data collected for the IPPS wage index also are currently used to calculate wage indexes applicable to suppliers and other providers, such as SNFs, home health agencies (HHAs), ambulatory surgical centers (ASCs), and hospices. In addition, they are used for prospective payments to IRFs, IPFs, and LTCHs, and for hospital outpatient services. We note that, in the IPPS rules, we do not address comments pertaining to the wage indexes of any supplier or provider except IPPS providers and LTCHs. Such comments should be made in response to separate proposed rules for those suppliers and providers. VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 C. Verification of Worksheet S–3 Wage Data The wage data for the proposed FY 2016 wage index were obtained from Worksheet S–3, Parts II and III of the Medicare cost report for cost reporting periods beginning on or after October 1, 2011, and before October 1, 2012. For wage index purposes, we refer to cost reports during this period as the ‘‘FY 2012 cost report,’’ the ‘‘FY 2012 wage data,’’ or the ‘‘FY 2012 data.’’ Instructions for completing the wage index sections of Worksheet S–3 are included in the Provider Reimbursement Manual (PRM), Part 2 (Pub. No. 15–2), Chapter 40, Sections 4005.2 through 4005.4 for Form CMS– 2552–10. The data file used to construct the proposed FY 2016 wage index includes FY 2012 data submitted to us as of February 25, 2015. As in past years, we performed an extensive review of the wage data, mostly through the use of edits designed to identify aberrant data. We asked our MACs to revise or verify data elements that result in specific edit failures. For the proposed FY 2016 wage index, we identified and excluded 93 providers with aberrant data that should not be included in the proposed wage index. If data elements for some of these providers with aberrant data are corrected, we intend to include data from those providers in the final FY 2016 wage index. We also adjusted certain aberrant data elements within a provider’s data and included these data in the proposed wage index. For example, in situations where a hospital did not have documentable salaries, wages, and hours for contract housekeeping and dietary services, we imputed estimates, in accordance with established policies as discussed in the FY 2015 IPPS/LTCH PPS final rule (79 FR 49965 through 49967). We instructed MACs to complete their data verification of questionable data elements and to transmit any changes to the wage data no later than February 25, 2015. We intend to resolve all unresolved data elements by the date the FY 2016 IPPS/LTCH PPS final rule is issued. The revised data will be reflected in the FY 2016 IPPS/LTCH PPS final rule. In constructing the proposed FY 2016 wage index, we included the wage data for facilities that were IPPS hospitals in FY 2012, inclusive of those facilities that have since terminated their participation in the program as hospitals, as long as those data did not fail any of our edits for reasonableness. We believe that including the wage data for these hospitals is, in general, PO 00000 Frm 00142 Fmt 4701 Sfmt 4702 appropriate to reflect the economic conditions in the various labor market areas during the relevant past period and to ensure that the current wage index represents the labor market area’s current wages as compared to the national average of wages. However, we excluded the wage data for CAHs as discussed in the FY 2004 IPPS final rule (68 FR 45397 through 45398). For this FY 2016 IPPS/LTCH PPS proposed rule, we removed 12 hospitals that converted to CAH status on or after February 13, 2014, the cut-off date for CAH exclusion from the FY 2015 wage index, and through and including February 5, 2015, the cut-off date for CAH exclusion from the FY 2016 wage index. After removing hospitals with aberrant data and hospitals that converted to CAH status, we calculated the proposed FY 2016 wage index based on 3,335 hospitals. For the proposed FY 2016 wage index, we allotted the wages and hours data for a multicampus hospital among the different labor market areas where its campuses are located in the same manner that we allotted such hospitals’ data in the FY 2015 wage index (79 FR 49964). Table 2, which contains the proposed FY 2016 wage index associated with this proposed rule (available via the Internet on the CMS Web site), includes separate wage data for the campuses of 7 multicampus hospitals. D. Method for Computing the Proposed FY 2016 Unadjusted Wage Index The method used to compute the proposed FY 2016 wage index without an occupational mix adjustment follows the same methodology that we used to compute the FY 2012, FY 2013, FY 2014, and FY 2015 final wage indexes without an occupational mix adjustment (76 FR 51591 through 51593, 77 FR 53366 through 53367, 78 FR 50587 through 50588, and 79 FR 49967, respectively). As discussed in the FY 2012 IPPS/ LTCH PPS final rule, in ‘‘Step 5,’’ for each hospital, we adjust the total salaries plus wage-related costs to a common period to determine total adjusted salaries plus wage-related costs. To make the wage adjustment, we estimate the percentage change in the employment cost index (ECI) for compensation for each 30-day increment from October 14, 2011, through April 15, 2013, for private industry hospital workers from the BLS’ Compensation and Working Conditions. We have consistently used the ECI as the data source for our wages and salaries and other price proxies in the IPPS market basket, and we are not proposing any changes to the usage for E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules FY 2016. The factors used to adjust the hospital’s data were based on the midpoint of the cost reporting period, as indicated in the following table. MIDPOINT OF COST REPORTING PERIOD After Before Adjustment factor 10/14/2011 11/14/2011 12/14/2011 01/14/2012 02/14/2012 03/14/2012 04/14/2012 05/14/2012 06/14/2012 07/14/2012 08/14/2012 09/14/2012 10/14/2012 11/14/2012 12/14/2012 01/14/2013 02/14/2013 03/14/2013 11/15/2011 12/15/2011 01/15/2012 02/15/2012 03/15/2012 04/15/2012 05/15/2012 06/15/2012 07/15/2012 08/15/2012 09/15/2012 10/15/2012 11/15/2012 12/15/2012 01/15/2013 02/15/2013 03/15/2013 04/15/2013 1.02167 1.02029 1.01893 1.01756 1.01620 1.01484 1.01348 1.01213 1.01080 1.00951 1.00825 1.00699 1.00568 1.00433 1.00292 1.00148 1.00000 0.98259 For example, the midpoint of a cost reporting period beginning January 1, 2012, and ending December 31, 2012, is June 30, 2012. An adjustment factor of 1.01080 would be applied to the wages of a hospital with such a cost reporting period. Using the data as described above, the proposed FY 2016 national average hourly wage (unadjusted for occupational mix) is $40.1203. The proposed FY 2016 Puerto Rico overall average hourly wage (unadjusted for occupational mix) is $16.718. tkelley on DSK3SPTVN1PROD with PROPOSALS2 E. Proposed Occupational Mix Adjustment to the FY 2016 Wage Index As stated earlier, section 1886(d)(3)(E) of the Act provides for the collection of data every 3 years on the occupational mix of employees for each short-term, acute care hospital participating in the Medicare program, in order to construct an occupational mix adjustment to the wage index, for application beginning October 1, 2004 (the FY 2005 wage index). The purpose of the occupational mix adjustment is to control for the effect of hospitals’ employment choices on the wage index. For example, hospitals may choose to employ different combinations of registered nurses, licensed practical nurses, nursing aides, and medical assistants for the purpose of providing nursing care to their patients. The varying labor costs associated with these choices reflect hospital management decisions rather than geographic differences in the costs of labor. VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 1. Development of Data for the Proposed FY 2016 Occupational Mix Adjustment Based on the 2013 Medicare Wage Index Occupational Mix Survey As provided for under section 1886(d)(3)(E) of the Act, we collect data every 3 years on the occupational mix of employees for each short-term, acute care hospital participating in the Medicare program. As discussed in the FY 2015 IPPS/ LTCH PPS final rule (79 FR 49967 through 49968), the occupational mix adjustment to the FY 2015 wage index was based on data collected on the 2010 Occupational Mix Survey Hospital Reporting Form (CMS–10079 (2010)). For the proposed FY 2016 wage index, we are proposing to use the occupational mix data collected on the new 2013 survey to compute the occupational mix adjustment for FY 2016, as discussed in section II.B.2. of the preamble of this proposed rule. 2. New 2013 Occupational Mix Survey for the Proposed FY 2016 Wage Index Section 304(c) of Public Law 106–554 amended section 1886(d)(3)(E) of the Act to require CMS to collect data every 3 years on the occupational mix of employees for each short-term, acute care hospital participating in the Medicare program. We collected data in 2010 to compute the occupational mix adjustment for the FY 2013, FY 2014, and FY 2015 wage index. Therefore, we were required to collect data in 2013 and are using these data to compute the occupational mix adjustment for the FY 2016 wage index. On December 7, 2012, we published in the Federal Register a notice soliciting comments on the proposed 2013 Medicare Wage Index Occupational Mix Survey (77 FR 73032 through 73033). The new 2013 survey, which is being applied to the proposed FY 2016 wage index, includes the same data elements and definitions as the 2010 survey and provides for the collection of hospital-specific wages and hours data for nursing employees for calendar year 2013 (that is, payroll periods ending between January 1, 2013 and December 31, 2013). The comment period for the notice ended on February 5, 2013. After considering the public comments that we received on the December 2012 notice, we made a few minor editorial changes and published the 2013 survey in the Federal Register on February 28, 2013 (78 FR 13679 through 13680). This survey was approved by OMB on May 14, 2013, and is available on the CMS Web site at: https://www.cms.gov/Medicare/ Medicare-Fee-for-Service-Payment/ PO 00000 Frm 00143 Fmt 4701 Sfmt 4702 24465 AcuteInpatientPPS/Downloads/WAGEINDEX-OCCUPATIONAL-MIXSURVEY2013.pdf. The 2013 Occupational Mix Survey Hospital Reporting Form CMS–10079 for the Wage Index Beginning FY 2016 (in Excel format) is available on the CMS Web site at: https://www.cms.gov/ Medicare/Medicare-Fee-for-ServicePayment/AcuteInpatientPPS/WageIndex-Files-Items/Medicare-WageIndex-Occupational-MixSurvey2013.html?DLPage= 1&DLSort=1&DLSortDir=descending. Hospitals were required to submit their completed 2013 surveys to their MACs by July 1, 2014. The preliminary, unaudited 2013 survey data were posted on the CMS Web site afterward, on July 11, 2014. As with the Worksheet S–3 cost report wage data, we asked our MACs to revise or verify data elements in hospitals’ occupational mix surveys that resulted in certain edit failures. Certain surveys with aberrant data elements are excluded from the proposed FY 2016 wage index, but any data elements resolved and revised in time to be included in the final wage index will be reflected in the FY 2016 IPPS/LTCH PPS final rule. 3. Calculation of the Proposed Occupational Mix Adjustment for FY 2016 For FY 2016, we are proposing to calculate the occupational mix adjustment factor using the same methodology that we used for the FY 2012, FY 2013, FY 2014, and FY 2015 wage indexes (76 FR 51582 through 51586, 77 FR 53367 through 53368, 78 FR 50588 through 50589, and 79 FR 49968, respectively). As a result of applying this methodology, the proposed FY 2016 occupational mix adjusted national average hourly wage is $40.0853. The proposed FY 2016 occupational mix adjusted Puerto Ricospecific average hourly wage is $16.6329. Because the occupational mix adjustment is required by statute, all hospitals that are subject to payments under the IPPS, or any hospital that would be subject to the IPPS if not granted a waiver, must complete the occupational mix survey, unless the hospital has no associated cost report wage data that are included in the FY 2016 wage index. For the proposed FY 2016 wage index, because we are using the Worksheet S–3, Parts II and III wage data of 3,335 hospitals, and we are using the occupational mix surveys of 3,039 hospitals for which we also have Worksheet S–3 wage data, that represents a ‘‘response’’ rate of 91.1 E:\FR\FM\30APP2.SGM 30APP2 24466 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules tkelley on DSK3SPTVN1PROD with PROPOSALS2 percent (3,039/3,335). In the proposed FY 2016 wage index in this proposed rule, we applied proxy data for noncompliant hospitals, new hospitals, or hospitals that submitted erroneous or aberrant data in the same manner that we applied proxy data for such hospitals in the FY 2012 wage index occupational mix adjustment (76 FR 51586). In the FY 2011 IPPS/LTCH PPS proposed rule and final rule (75 FR 23943 and 75 FR 50167, respectively), we stated that, in order to gain a better understanding of why some hospitals are not submitting the occupational mix data, we will require hospitals that do not submit occupational mix data to provide an explanation for not complying. This requirement was effective for the 2013 occupational mix survey as well as the 2010 occupational mix survey. We instructed MACs to continue gathering this information as part of the FY 2016 wage index desk review process. We stated that we would review these data for future analysis and consideration of potential penalties for noncompliant hospitals. F. Analysis and Implementation of the Proposed Occupational Mix Adjustment and the Proposed FY 2016 Occupational Mix Adjusted Wage Index As discussed in section III.E. of the preamble of this proposed rule, for FY 2016, we apply the occupational mix adjustment to 100 percent of the proposed FY 2016 wage index. We calculated the proposed occupational mix adjustment using data from the 2013 occupational mix survey data, using the methodology described in the FY 2012 IPPS/LTCH PPS final rule (76 FR 51582 through 51586). Using the occupational mix survey data and applying the occupational mix adjustment to 100 percent of the proposed FY 2016 wage index results in a proposed national average hourly wage of $40.0853 and a proposed Puerto-Rico specific average hourly wage of $16.6329. After excluding data of hospitals that either submitted aberrant data that failed critical edits or that did not have FY 2012 Worksheet S– 3, Parts II and III, cost report data for use in calculating the proposed FY 2016 wage index, we calculated the proposed FY 2016 wage index using the occupational mix survey data from 3,039 hospitals. For the proposed FY 2016 wage index, because we are using the Worksheet S–3, Parts II and III wage data of 3,335 hospitals, and we are using the occupational mix survey data of 3,039 hospitals for which we also have Worksheet S–3 wage data, those data represent a ‘‘response’’ rate of 91.1 VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 percent (3,039/3,335). The proposed FY 2016 national average hourly wages for each occupational mix nursing subcategory as calculated in Step 2 of the occupational mix calculation are as follows: Occupational mix nursing subcategory Proposed average hourly wage National RN .......................... National LPN and Surgical Technician ......................... National Nurse Aide, Orderly, and Attendant .................... National Medical Assistant ... National Nurse Category ...... 38.70789914 22.793680926 15.944111418 18.009577806 32.783151666 The proposed national average hourly wage for the entire nurse category as computed in Step 5 of the occupational mix calculation is $32.783151666. Hospitals with a nurse category average hourly wage (as calculated in Step 4 of the occupational mix calculation) of greater than the national nurse category average hourly wage receive an occupational mix adjustment factor (as calculated in Step 6 of the occupational mix calculation) of less than 1.0. Hospitals with a nurse category average hourly wage (as calculated in Step 4 of the occupational mix calculation) of less than the national nurse category average hourly wage receive an occupational mix adjustment factor (as calculated in Step 6 of the occupational mix calculation) of greater than 1.0. Based on the 2013 occupational mix survey data, we determined (in Step 7 of the occupational mix calculation) that the national percentage of hospital employees in the nurse category is 42.54 percent, and the national percentage of hospital employees in the all other occupations category is 57.46 percent. At the CBSA level, the percentage of hospital employees in the nurse category ranged from a low of 26.72 percent in one CBSA to a high of 80.55 percent in another CBSA. The proposed FY 2016 Puerto Ricospecific average hourly wages for each occupational mix nursing subcategory as calculated in Step 2 of the occupational mix calculation are as follows: Proposed Puerto Rico average hourly wage Occupational mix nursing subcategory Puerto Rico RN .................... Puerto Rico LPN and Surgical Technician ................ Puerto Rico Nurse Aide, Orderly, and Attendant .......... Puerto Rico Medical Assistant ..................................... PO 00000 Frm 00144 Fmt 4701 16.762672135 10.053073049 9.695410146 21.962356196 Sfmt 4702 Occupational mix nursing subcategory Proposed Puerto Rico average hourly wage Puerto Rico Nurse Category 14.563182257 Based on the 2013 occupational mix survey data, we determined (in Step 7 of the occupational mix calculation) that the Puerto Rico percentage of hospital employees in the nurse category is 49.93 percent, and the Puerto Rico percentage of hospital employees in the all other occupations category is 50.07 percent. We also compared the proposed FY 2016 wage data adjusted for occupational mix from the 2013 survey to the proposed FY 2016 wage data adjusted for occupational mix from the 2010 survey. This analysis illustrates the effect on area wage indexes of using the 2013 survey data compared to the 2010 survey data; that is, it shows whether hospitals’ wage indexes would increase or decrease under the 2013 survey data as compared to the prior 2010 survey data. Of the 407 urban CBSAs and 47 rural CBSAs, our analysis shows that the proposed FY 2016 wage index values for 183 (45.0 percent) urban areas and 20 (42.6 percent) rural areas would increase. Fifty-three (13.0 percent) urban areas would increase by greater than or equal to 1 percent but less than 5 percent, and 5 (1.2 percent) urban areas would increase by 5 percent or more. Four (8.5 percent) rural areas would increase by greater than or equal to 1 percent but less than 5 percent, and no rural areas would increase by 5 percent or more. However, the proposed wage index values for 220 (54.1 percent) urban areas and 27 (57.4 percent) rural areas would decrease using the 2013 survey data. Seventy-two (17.7 percent) urban areas would decrease by greater than or equal to 1 percent but less than 5 percent, and one (0.2 percent) urban area would decrease by 5 percent or more. Seven (14.9 percent) rural areas would decrease by greater than or equal to 1 percent but less than 5 percent, and no rural areas would decrease by 5 percent or more. The largest positive impacts using the 2013 survey data compared to the 2010 survey data are 15.0 percent for an urban area and 3.8 percent for a rural area. The largest negative impacts are 5.0 percent for an urban area and 1.9 percent for two rural areas. Four urban areas and no rural areas would be unaffected. These results indicate that the proposed wage indexes of more CBSAs overall (54.4 percent) would decrease due to application of the 2013 occupational mix survey data as compared to the 2010 occupational mix survey data to the wage index. E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules Further, a larger percentage of urban areas (45.0 percent) would benefit from the use of the 2013 occupational mix survey data as compared to the 2010 occupational mix survey data than would rural areas (42.6 percent). We compared the proposed FY 2016 occupational mix adjusted wage indexes for each CBSA to the proposed unadjusted wage indexes for each CBSA. As a result of applying the occupational mix adjustment to the wage data, the proposed wage index values for 222 (54.5 percent) urban areas and 24 (51.1 percent) rural areas would increase. One hundred one (24.8 percent) urban areas would increase by greater than or equal to 1 percent but less than 5 percent, and 6 (1.5 percent) urban areas would increase by 5 percent or more. Nine (19.1 percent) rural areas would increase by greater than or equal to 1 percent but less than 5 percent, and no rural areas would increase by 5 percent or more. However, the proposed wage index values for 185 (45.5 percent) urban areas and 23 (48.9 percent) rural areas would decrease. Ninety-three (22.9 percent) urban areas would decrease by greater than or equal to 1 percent but less than 5 percent, and no urban areas would decrease by 5 percent or more. Eight (17.0 percent) rural areas would decrease by greater than or equal to 1 percent but less than 5 percent, and no rural areas would decrease by 5 percent or more. The largest positive impacts would be 17.4 percent for an urban area and 2.7 percent for two rural areas. The largest negative impacts would be 4.7 percent for an urban area and 2.1 percent for a rural area. No urban or rural areas would remain unchanged by application of the proposed occupational mix adjustment. These results indicate that a larger percentage of urban areas (54.5 percent) would benefit from application of the proposed occupational mix adjustment than would rural areas (51.1 percent). tkelley on DSK3SPTVN1PROD with PROPOSALS2 G. Transitional Wage Indexes 1. Background In the FY 2015 IPPS/LTCH PPS proposed rule and final rule (79 FR 28060 and 49957, respectively), we stated that, overall, we believed implementing the new OMB labor market area delineations would result in wage index values being more representative of the actual costs of labor in a given area. However, we recognized that some hospitals would experience decreases in wage index values as a result of the implementation of these new OMB labor market area delineations. We also realized that some hospitals would have higher wage index VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 values due to the implementation of the new OMB labor market area delineations. The FY 2015 IPPS/LTCH PPS final rule (79 FR 49957) explained the methodology utilized in implementing prior transition periods when adopting changes that have significant payment implications, particularly large negative impacts. Specifically, for FY 2005, in the FY 2005 IPPS final rule (69 FR 49032 through 49034), we provided transitional wage indexes when the OMB definitions were implemented after the 2000 Census. The FY 2015 IPPS/LTCH PPS final rule (79 FR 49957 through 49962) established similar transition methodologies to mitigate any negative payment impacts experienced by hospitals due to our adoption of the new OMB labor market area delineations for FY 2015. As finalized in the FY 2015 IPPS/ LTCH PPS final rule (79 FR 49957 through 49960) and as discussed below, for FY 2016, we are in the second year of two 3-year transition periods for wage index: one for hospitals that, for FY 2014, were located in an urban county that became rural under the new OMB delineations, and had no form of wage index reclassification or redesignation in place for FY 2015 (that is, MGCRB reclassifications under section 1886(d)(10) of the Act, redesignations under section 1886(d)(8)(B) of the Act, or rural reclassifications under section 1886(d)(8)(E) of the Act); and one for hospitals deemed urban under section 1886(d)(8)(B) of the Act where the urban area became rural under the new OMB delineations. In addition, the 1-year transition that we applied in FY 2015 for hospitals that experienced a decrease in wage index under the new OMB delineations expires at the end of FY 2015 and does not apply in FY 2016. 2. Transition for Hospitals in Urban Areas That Became Rural In the FY 2015 IPPS/LTCH PPS final rule (79 FR 49957 through 49959), for hospitals that, for FY 2014, were located in an urban county that became rural under the new OMB delineations, and had no form of wage index reclassification or redesignation in place for FY 2015 (that is, MGCRB reclassifications under section 1886(d)(10) of the Act, redesignations under section 1886(d)(8)(B) of the Act, or rural reclassifications under section 1886(d)(8)(E) of the Act), we adopted a policy to assign them the urban wage index value of the CBSA in which they are physically located for FY 2014 for a period of 3 fiscal years (with the rural and imputed floors applied and with the rural floor budget neutrality adjustment PO 00000 Frm 00145 Fmt 4701 Sfmt 4702 24467 applied to the area wage index). FY 2016 will represent the second year of this transition policy, and we are not proposing any changes to this policy in this proposed rule. In the FY 2015 IPPS/ LTCH PPS final rule (79 FR 49957), we stated our belief that it is appropriate to apply a 3-year transition period for hospitals located in urban counties that would become rural under the new OMB delineations, given the potentially significant payment impacts for these hospitals. We continue to believe that assigning the wage index of the hospitals’ FY 2014 area for a 3-year transition is the simplest and most effective method for mitigating negative payment impacts due to the adoption of the new OMB delineations. In the FY 2015 IPPS/LTCH PPS final rule (79 FR49959), we noted that there were situations where a hospital could not be assigned the wage index value of the CBSA in which it geographically was located in FY 2014 because that CBSA split and no longer exists and some or all of the constituent counties were added to another urban labor market area under the new OMB delineations. If the hospital could not be assigned the wage index value of the CBSA in which it was geographically located in FY 2014 because that CBSA split apart and no longer exists, and some or all of its constituent counties were added to another urban labor market area under the new OMB delineations, we established that hospitals located in such counties that became rural under the new OMB delineations were assigned the wage index of the urban labor market area that contains the urban county in their FY 2014 CBSA to which they are closest (with the rural and imputed floors applied and with the rural floor budget neutrality adjustment applied). Any such assignment made in FY 2015 will continue for FYs 2016 and 2017, except as discussed below. We continue to believe this approach minimizes the negative effects of the change in the OMB delineations. Under the policy adopted in the FY 2015 IPPS/LTCH PPS final rule, if a hospital for FY 2014 was located in an urban county that became rural for FY 2015 under the new OMB delineations and such hospital sought and was granted reclassification or redesignation for FY 2015 or such hospital seeks and is granted any reclassification or redesignation for FY 2016 or FY 2017, the hospital will permanently lose its 3year transitional assigned wage index status, and will not be eligible to reinstate it. We established the transition policy to assist hospitals if they experience a negative payment E:\FR\FM\30APP2.SGM 30APP2 tkelley on DSK3SPTVN1PROD with PROPOSALS2 24468 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules impact specifically due to the adoption of the new OMB delineations in FY 2015. If a hospital chooses to forego this transition adjustment by obtaining some form of reclassification or redesignation, we do not believe reinstatement of this transition adjustment would be appropriate. The purpose of the transition adjustment policy is to assist hospitals that may be negatively impacted by the new OMB delineations in transitioning to a wage index based on these delineations. By obtaining a reclassification or redesignation, we believe that the hospital has made the determination that the transition adjustment is not necessary because it has other viable options for mitigating the impact of the transition to the new OMB delineations. As we did for FY 2015 (79 FR 49959), with respect to the wage index computation for FY 2016, we will follow our existing policy regarding the inclusion of a hospital’s wage index data in the CBSA in which it is geographically located (we refer readers to Step 6 of the method for computing the unadjusted wage index in the FY 2012 IPPS/LTCH PPS final rule (76 FR 51592)). Accordingly, as we began with FY 2015, for FY 2016, the wage data of all hospitals receiving this type of 3-year transition adjustment will be included in the statewide rural area in which they are geographically located under the new OMB labor market area delineations. After the 3-year transition period, beginning in FY 2018, these formerly urban hospitals discussed above will receive their statewide rural wage index, absent any reclassification or redesignation. In addition, we established in the FY 2015 IPPS/LTCH PPS final rule (79 FR 49959) that the hospitals receiving this 3-year transition because they are in counties that were urban under the FY 2014 CBSA definitions, but are rural under the new OMB delineations, will not be considered urban hospitals. Rather, they will maintain their status as rural hospitals for other payment considerations. This is because our application of a 3-year transitional wage index for these newly rural hospitals only applies for the purpose of calculating the wage index under our adoption of the new OMB delineations. We did not establish transitions for other IPPS payment policies that may be impacted by our adoption of the new OMB delineations. VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 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 As discussed in the FY 2015 IPPS/ LTCH PPS final rule (79 FR 49959 through 49960), there were some hospitals that, for FY 2014, were geographically located in rural areas but were deemed to be urban under section 1886(d)(8)(B) of the Act. For FY 2015, some of these hospitals redesignated under section 1886(d)(8)(B) of the Act were no longer eligible for deemed urban status under the new OMB delineations, as discussed in detail in section III.H.3. of the preamble of the FY 2015 IPPS/LTCH PPS final rule. Similar to the policy implemented in the FY 2005 IPPS final rule (69 FR 49059), and consistent with the FY 2015 policy we established for other hospitals in counties that were urban and became rural under the new OMB delineations, we finalized a policy to apply a 3-year transition to these hospitals redesignated to urban areas under section 1886(d)(8)(B) of the Act for FY 2014 that are no longer deemed urban under the new OMB delineations and revert to being rural. For FY 2016, we are not proposing any changes to this policy and will continue to the second year of the implementation of our policy to provide a 3-year transition adjustment to hospitals that are deemed urban under section 1886(d)(8)(B) of the Act under the FY 2014 labor market area delineations, but are considered rural under the new OMB delineations, assuming no other form of wage index reclassification or redesignation is granted. We assign these hospitals the area wage index value of hospitals reclassified to the urban CBSA (that is, the attaching wage index) to which they were redesignated in FY 2014 (with the rural and imputed floors applied and with the rural floor budget neutrality adjustment applied). If the hospital cannot be assigned the reclassified wage index value of the CBSA to which it was redesignated in FY 2014 because that CBSA was split apart and no longer exists, and some or all of its constituent counties were added to another urban labor market area under the new OMB delineations, such hospitals are assigned the wage index of the hospitals reclassified to the urban labor market area that contains the urban county in their FY 2014 redesignated CBSA to which they are closest. We assign these hospitals the area wage index of hospitals reclassified to a CBSA because hospitals deemed urban under section 1886(d)(8)(B) of the Act are treated as PO 00000 Frm 00146 Fmt 4701 Sfmt 4702 reclassified under current policy, under which such hospitals receive an area wage index that includes wage data of all hospitals reclassified to the area. This wage index assignment will be forfeited if the hospital obtains any form of wage index reclassification or redesignation. 4. Expiring Transition for Hospitals That Experience a Decrease in Wage Index Under the New OMB Delineations In the FY 2015 IPPS/LTCH PPS final rule (79 FR 49960 through 49962), we stated that, while we believe that instituting the latest OMB labor market area delineations would create a more accurate wage index system, we also recognized that implementing the latest OMB delineations may cause some short-term instability in hospital payments. Therefore, in addition to the 3-year transition adjustments for hospitals being transitioned from urban to rural status as discussed earlier, in the FY 2015 IPPS/LTCH PPS final rule, we established a 1-year blended wage index for all hospitals that would experience any decrease in their actual payment wage index. This 1-year blended wage index expires at the end of FY 2015. We are not proposing any additional transition adjustment for hospitals that experienced a decrease in wage index values due to the adoption of the new OMB delineations for FY 2015 but, as discussed previously, will continue the 3-year transition adjustments for hospitals that changed from urban to rural status that we finalized in the FY 2015 IPPS/LTCH PPS final rule. We established a longer 3-year transition adjustment for hospitals losing urban status because there are significantly fewer affected urban-to-rural hospitals, and we believe the negative impacts to a hospital shifting from urban to rural status are typically greater than other types of transitions. We stated our belief that a transition period longer than 1 year to address other impacts of the adoption of the new OMB delineations would reduce the accuracy of the overall labor market area wage index system because far more hospitals would be affected. The 1-year transition for all negatively affected hospitals in FY 2015 provided an opportunity for hospitals to evaluate potential reclassification options, and mitigated initial negative impacts due to labor market assignment changes. We continue to believe that the adoption of the latest labor market delineations improves the accuracy and integrity of the hospital wage index system. Therefore, we believe it is necessary to allow this transition adjustment to expire. E:\FR\FM\30APP2.SGM 30APP2 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules 5. Budget Neutrality In the FY 2015 IPPS/LTCH PPS final rule (79 FR 50372 through 50373), for FY 2015, we applied the 3-year transition and 50/50 blended wage index adjustments in a budget neutral manner. For FY 2016, we are proposing to apply the 3-year transition adjustments in a budget neutral manner. We are proposing to make an adjustment to the standardized amount to ensure that the total payments, including the effect of the transition provisions, would equal what payments would have been if we would not be providing for any transitional wage indexes under the new OMB delineations. For a complete discussion on the proposed budget neutrality adjustment for FY 2016, we refer readers to section II.A.4.b. of the Addendum to this proposed rule. H. Proposed Application of the Proposed Rural, Imputed, and Frontier Floors tkelley on DSK3SPTVN1PROD with PROPOSALS2 1. Proposed Rural Floor Section 4410(a) of Public Law 105–33 provides that, for discharges on or after October 1, 1997, the area wage index applicable to any hospital that is located in an urban area of a State may not be less than the area wage index applicable to hospitals located in rural areas in that State. This provision is referred to as the ‘‘rural floor.’’ Section 3141 of Public Law 111–148 also requires that a national budget neutrality adjustment be applied in implementing the rural floor. Based on the proposed FY 2016 wage index associated with this proposed rule, we estimated that 459 hospitals would receive an increase in their FY 2016 proposed wage index due to the application of the rural floor. 2. Proposed Imputed Floor for FY 2016 In the FY 2005 IPPS final rule (69 FR 49109 through 49111), we adopted the ‘‘imputed floor’’ policy as a temporary 3-year regulatory measure to address concerns from hospitals in all-urban States that have argued that they are disadvantaged by the absence of rural hospitals to set a wage index floor for those States. Since its initial implementation, we have extended the imputed floor policy five times, the last of which was adopted in the FY 2015 IPPS/LTCH PPS final rule and is set to expire on September 30, 2015. (We refer readers to further discussions of the imputed floor in the FY 2014 and FY 2015 IPPS/LTCH PPS final rules (78 FR 50589 through 50590 and 79 FR 49969 through 49970, respectively) and to the regulations at 42 CFR 412.64(h)(4).) Currently, there are three all-urban VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 States, Delaware, New Jersey, and Rhode Island, with a range of wage indexes assigned to hospitals in these States, including through reclassification or redesignation (we refer readers to discussions of geographic reclassifications and redesignations in section III.J. of the preamble of this proposed rule). In computing the imputed floor for an all-urban State under the original methodology, which was established beginning in FY 2005, we calculated the ratio of the lowest-to-highest CBSA wage index for each all-urban State as well as the average of the ratios of lowest-to-highest CBSA wage indexes of those all-urban States. We then compared the State’s own ratio to the average ratio for all-urban States and whichever is higher is multiplied by the highest CBSA wage index value in the State—the product of which established the imputed floor for the State. As of FY 2012, there were only two all-urban States, New Jersey and Rhode Island, and only New Jersey benefitted under this methodology. Under the previous OMB labor market area delineations, Rhode Island had only one CBSA