56762 Federal Register/Vol. 81, No. 162/Monday, August 22, 2016/Rules and Regulations DEPARTMENT OF HEALTH AND requirements or revising existing Mollie Knight (410) 786–7948, and HUMAN SERVICES requirements for quality reporting by Bridget Dickensheets, (410) 786–8670, specific Medicare providers (acute care Rebasing and Revising the LTCH Market Centers for Medicare & Medicaid hospitals, PPS-exempt cancer hospitals, Basket Issues. Services LTCHs, and inpatient psychiatric Siddhartha Mazumdar, (410) 786– facilities), including related provisions 6673, Rural Community Hospital 42 CFR Parts 405, 412, 413, and 489 for eligible hospitals and critical access Demonstration Program Issues. hospitals (CAHs) participating in the Jason Pteroski, (410) 786–4681, and [CMS–1655–F; CMS–16644–F; CMS–1632– Electronic Health Record Incentive Siddhartha Mazumdar, (410) 786–6673, F2] Program; updating policies relating to Frontier Community Health Integration RIN 0938–AS77; 0938–AS88; 0938–AS41 the Hospital Value-Based Purchasing Project Demonstration Issues. Program, the Hospital Readmissions Kathryn McCann Smith, (410) 786– Medicare Program; Hospital Inpatient Reduction Program, and the Hospital- 7623, Hospital Notification Procedures Prospective Payment Systems for Acquired Condition Reduction Program; for Beneficiaries Receiving Outpatient Acute Care Hospitals and the Long- implementing statutory provisions that Observation Services Issues; or Term Care Hospital Prospective require hospitals and CAHs to furnish Stephanie Simons, (206) 615–2420, only Payment System and Policy Changes notification to Medicare beneficiaries, for Related Medicare Health Plans and Fiscal Year 2017 Rates; Quality including Medicare Advantage Issues. Reporting Requirements for Specific enrollees, when the beneficiaries receive Lein Han, (617) 879–0129, Hospital Providers; Graduate Medical outpatient observation services for more Readmissions Reduction Program— Education; Hospital Notification than 24 hours; announcing the Readmission Measures for Hospitals Procedures Applicable to Beneficiaries implementation of the Frontier Issues. Receiving Observation Services; Community Health Integration Project Delia Houseal, (410) 786–2724, Technical Changes Relating to Costs Demonstration; and making technical Hospital-Acquired Condition Reduction to Organizations and Medicare Cost corrections and changes to regulations Program and Hospital Readmissions Reports; Finalization of Interim Final relating to costs to related organizations Reduction Program—Administration Rules With Comment Period on LTCH and Medicare cost reports; we are Issues. PPS Payments for Severe Wounds, providing notice of the closure of three Joseph Clift, (410) 786–4165, Modifications of Limitations on teaching hospitals and the opportunity Hospital-Acquired Condition Reduction Redesignation by the Medicare to apply for available GME resident slots Program—Measures Issues. Geographic Classification Review James Poyer, (410) 786–2261, Hospital under section 5506 of the Affordable Board, and Extensions of Payments to Inpatient Quality Reporting and Care Act. MDHs and Low-Volume Hospitals We are finalizing the provisions of Hospital Value-Based Purchasing— AGENCY: Centers for Medicare and itnhtaetr riemla ftien taol aru tleems pwoirtahr cyo emxcmeepntito pne froior d Panrodg Rraemco Ansdimdeirnaitsitorant iIossnu, eVsa. lidation, Medicaid Services (CMS), HHS. Cindy Tourison, (410) 786–1093, certain wound care discharges from the ACTION: Final rule. Hospital Inpatient Quality Reporting— application of the site neutral payment Measures Issues Except Hospital SUMMARY: We are revising the Medicare rate under the LTCH PPS for certain Consumer Assessment of Healthcare hospital inpatient prospective payment LTCHs; application of two judicial Providers and Systems Issues; and systems (IPPS) for operating and capital- decisions relating to modifications of Readmission Measures for Hospitals related costs of acute care hospitals to limitations on redesignation by the Issues. implement changes arising from our Medicare Geographic Classification Kim Spaulding Bush, (410) 786–3232, continuing experience with these Review Board; and legislative Hospital Value-Based Purchasing systems for FY 2017. Some of these extensions of the Medicare-dependent, Efficiency Measures Issues. changes will implement certain small rural hospital program and Elizabeth Goldstein, (410) 786–6665, statutory provisions contained in the changes to the payment adjustment for Hospital Inpatient Quality Reporting— Pathway for Sustainable Growth Reform low-volume hospitals. Hospital Consumer Assessment of Act of 2013, the Improving Medicare DATES: Effective Date: These final rules Healthcare Providers and Systems Post-Acute Care Transformation Act of are effective on October 1, 2016. Measures Issues. 2014, the Notice of Observation FORFURTHERINFORMATIONCONTACT: Ing James Poyer, (410) 786–2261, PPS- Treatment and Implications for Care Jye Cheng, (410) 786–4548, and Donald Exempt Cancer Hospital Quality Eligibility Act of 2015, and other Thompson, (410) 786–44487, Operating Reporting Issues. legislation. We also are providing the Prospective Payment, MS–DRGs, Wage Mary Pratt, (410) 786–6867, Long- estimated market basket update to apply Index, New Medical Service and Term Care Hospital Quality Data to the rate-of-increase limits for certain Technology Add-On Payments, Hospital Reporting Issues. hospitals excluded from the IPPS that Geographic Reclassifications, Graduate Jeffrey Buck, (410) 786–0407 and are paid on a reasonable cost basis Medical Education, Capital Prospective Cindy Tourison (410) 786–1093, subject to these limits for FY 2017. Payment, Excluded Hospitals, Medicare Inpatient Psychiatric Facilities Quality We are updating the payment policies Disproportionate Share Hospital (DSH) Data Reporting Issues. and the annual payment rates for the Issues, Medicare-Dependent Small Rural Deborah Krauss, (410) 786–5264, and S2 Medicare prospective payment system Hospital (MDH) Program, and Low- Lisa Marie Gomez, (410) 786–1175, EHR ULE (PPS) for inpatient hospital services Volume Hospital Payment Adjustment Incentive Program Clinical Quality D with R p(LrTovCiHdes)d f obry FloYn 2g0-t1e7rm. care hospitals IssMueics.h ele Hudson, (410) 786–4487, and MeEalsizuarbee Rthe lMateyder Iss,s (u4e1s0. ) 786–4751, EHR RO In addition, we are making changes Emily Lipkin, (410) 786–3633, Long- Incentive Program Nonclinical Quality P G9T082 reedluatciantgio tno (dGirMecEt) garnadd uinadtei rmecetd miceadl ical TPaeyrmm eCnatr Se yHsotesmpi taanl dP rMosSp–eLcTtiCv–eD RG MeLaasuurreen R Welua,t e(2d0 I2ss) u6e9s0. –7151, Certified K3 education payments; establishing new Relative Weights Issues. EHR Technology Related Issues. S D mstockstill on VerDate Sep<11>2014 20:18 Aug 19, 2016 Jkt 238001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\22AUR2.SGM 22AUR2 Federal Register/Vol. 81, No. 162/Monday, August 22, 2016/Rules and Regulations 56763 Kellie Shannon, (410) 786–0416, ALOS Average length of stay DPP Disproportionate patient percentage Technical Changes Relating to Costs to ALTHA Acute Long-Term Hospital DRA Deficit Reduction Act of 2005, Public Organizations and Medicare Cost Association Law 109–171 AMA American Medical Association DRG Diagnosis-related group Reports Issues. AMGA American Medical Group DSH Disproportionate share hospital SUPPLEMENTARYINFORMATION: Association EBRT External beam radiotherapy AMI Acute myocardial infarction ECE Extraordinary circumstances Electronic Access AOA American Osteopathic Association exemption This Federal Register document is APR DRG All Patient Refined Diagnosis ECI Employment cost index available from the Federal Register Related Group System eCQM Electronic clinical quality measure online database through Federal Digital APRN Advanced practice registered nurse EDB [Medicare] Enrollment Database System (FDsys), a service of the U.S. ARRA American Recovery and EHR Electronic health record Reinvestment Act of 2009, Public Law EMR Electronic medical record Government Printing Office. This 111–5 EMTALA Emergency Medical Treatment database can be accessed via the ASCA Administrative Simplification and Labor Act of 1986, Public Law 99–272 Internet at: http://www.gpo.gov/fdsys. Compliance Act of 2002, Public Law 107– EP Eligible professional 105 FAH Federation of American Hospitals Tables Available Only Through the ASITN American Society of Interventional FDA Food and Drug Administration Internet on the CMS Web Site and Therapeutic Neuroradiology FFY Federal fiscal year In the past, a majority of the tables ASPE Assistant Secretary for Planning and FPL Federal poverty line referred to throughout this preamble Evaluation (DHHS) FQHC Federally qualified health center and in the Addendum to the proposed ATRA American Taxpayer Relief Act of FR Federal Register 2012, Public Law 112–240 FTE Full-time equivalent rule and the final rule were published BBA Balanced Budget Act of 1997, Public FY Fiscal year in the Federal Register as part of the Law 105–33 GAF Geographic Adjustment Factor annual proposed and final rules. BBRA Medicare, Medicaid, and SCHIP GME Graduate medical education However, beginning in FY 2012, some of [State Children’s Health Insurance HAC Hospital-acquired condition the IPPS tables and LTCH PPS tables are Program] Balanced Budget Refinement Act HAI Healthcare-associated infection no longer published in the Federal of 1999, Public Law 106–113 HCAHPS Hospital Consumer Assessment of Register. Instead, these tables generally BIPA Medicare, Medicaid, and SCHIP [State Healthcare Providers and Systems Children’s Health Insurance Program] HCFA Health Care Financing will be available only through the Benefits Improvement and Protection Act Administration Internet. The IPPS tables for this final of 2000, Public Law 106–554 HCO High-cost outlier rule are available through the Internet BLS Bureau of Labor Statistics HCP Healthcare personnel on the CMS Web site at: http:// CABG Coronary artery bypass graft HCRIS Hospital Cost Report Information www.cms.hhs.gov/Medicare/Medicare- [surgery] System Fee-for-Service-Payment/ CAH Critical access hospital HF Heart failure AcuteInpatientPPS/index.html. Click on CARE [Medicare] Continuity Assessment HHA Home health agency the link on the left side of the screen Record & Evaluation [Instrument] HHS Department of Health and Human CART CMS Abstraction & Reporting Tool Services titled, ‘‘FY 2017 IPPS Final Rule Home CAUTI Catheter-associated urinary tract HICAN Health Insurance Claims Account Page’’ or ‘‘Acute Inpatient—Files for infection Number Download’’. The LTCH PPS tables for CBSAs Core-based statistical areas HIPAA Health Insurance Portability and this FY 2017 final rule are available CC Complication or comorbidity Accountability Act of 1996, Public Law through the Internet on the CMS Web CCN CMS Certification Number 104–191 site at: http://www.cms.gov/Medicare/ CCR Cost-to-charge ratio HIPC Health Information Policy Council Medicare-Fee-for-Service-Payment/ CDAC [Medicare] Clinical Data Abstraction HIS Health information system LongTermCareHospitalPPS/index.html Center HIT Health information technology CDAD Clostridium difficile-associated HMO Health maintenance organization under the list item for Regulation disease HPMP Hospital Payment Monitoring Number CMS–1655–F. For further CDC Centers for Disease Control and Program details on the contents of the tables Prevention HSA Health savings account referenced in this final rule, we refer CERT Comprehensive error rate testing HSCRC [Maryland] Health Services Cost readers to section VI. of the Addendum CDI Clostridium difficile [C. difficile] Review Commission to this final rule. infection HSRV Hospital-specific relative value Readers who experience any problems CFR Code of Federal Regulations HSRVcc Hospital-specific relative value accessing any of the tables that are CLABSI Central line-associated cost center bloodstream infection HQA Hospital Quality Alliance posted on the CMS Web sites identified CIPI Capital input price index HQI Hospital Quality Initiative above should contact Michael Treitel at CMI Case-mix index HwH Hospital-within-hospital (410) 786–4552. CMS Centers for Medicare & Medicaid ICD–9–CM International Classification of Acronyms Services Diseases, Ninth Revision, Clinical CMSA Consolidated Metropolitan Modification 3M 3M Health Information System Statistical Area ICD–10–CM International Classification of AAMC Association of American Medical COBRA Consolidated Omnibus Diseases, Tenth Revision, Clinical Colleges Reconciliation Act of 1985, Public Law 99– Modification ACGME Accreditation Council for Graduate 272 ICD–10–PCS International Classification of Medical Education COLA Cost-of-living adjustment Diseases, Tenth Revision, Procedure ACoS American College of Surgeons CoP [Hospital] condition of participation Coding System ES2 AHA American Hospital Association COPD Chronic obstructive pulmonary ICR Information collection requirement RUL AHIC American Health Information disease ICU Intensive care unit with Community CPI Consumer price index IGI IHS Global Insight, Inc. D AHIMA American Health Information CQL Clinical quality language IHS Indian Health Service O PR Management Association CQM Clinical quality measure IME Indirect medical education T082 AHRQ Agency for Healthcare Research and CY Calendar year IMPACT Act Improving Medicare Post- G9 Quality DACA Data Accuracy and Completeness Acute Care Transformation Act of 2014, SK3 AJCC American Joint Committee on Cancer Acknowledgement Public Law 113–185 D mstockstill on VerDate Sep<11>2014 20:18 Aug 19, 2016 Jkt 238001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 E:\FR\FM\22AUR2.SGM 22AUR2 56764 Federal Register/Vol. 81, No. 162/Monday, August 22, 2016/Rules and Regulations I–O Input-Output NHSN National Healthcare Safety Network RRC Rural referral center IOM Institute of Medicine NOP Notice of Participation RSMR Risk-standard mortality rate IPF Inpatient psychiatric facility NOTICE Act Notice of Observation RSP Risk-standardized payment IPFQR Inpatient Psychiatric Facility Treatment and Implication for Care RSSR Risk-standard readmission rate Quality Reporting [Program] Eligibility Act, Public Law 114–42 RTI Research Triangle Institute, IPPS [Acute care hospital] inpatient NQF National Quality Forum International prospective payment system NQS National Quality Strategy RUCAs Rural-urban commuting area codes IRF Inpatient rehabilitation facility NTIS National Technical Information RY Rate year IQR [Hospital] Inpatient Quality Reporting Service SAF Standard Analytic File LAMCs Large area metropolitan counties NTTAA National Technology Transfer and SCH Sole community hospital LEP Limited English proficiency Advancement Act of 1991, Public Law SCHIP State Child Health Insurance LOC Limitation on charges 104–113 Program LOS Length of stay NUBC National Uniform Billing Code SCIP Surgical Care Improvement Project LTC–DRG Long-term care diagnosis-related NVHRI National Voluntary Hospital SFY State fiscal year group Reporting Initiative SGR Sustainable Growth Rate LTCH Long-term care hospital OACT [CMS’] Office of the Actuary SIC Standard Industrial Classification LTCH QRP Long-Term Care Hospital OBRA 86 Omnibus Budget Reconciliation SIR Standardized infection ratio Quality Reporting Program Act of 1986, Public Law 99–509 SNF Skilled nursing facility MA Medicare Advantage OES Occupational employment statistics SNF QRP Skilled Nursing Facility Quality MAC Medicare Administrative Contractor OIG Office of the Inspector General Reporting Program MACRA Medicare Access and CHIP OMB [Executive] Office of Management and SNF VBP Skilled Nursing Facility Value- Reauthorization Act of 2015, Public Law Budget Based Purchasing 114–10 ONC Office of the National Coordinator for SOCs Standard occupational classifications MAP Measure Application Partnership Health Information Technology SOM State Operations Manual MCC Major complication or comorbidity OPM [U.S.] Office of Personnel SRR Standardized risk ratio MCE Medicare Code Editor Management SSI Surgical site infection MCO Managed care organization OQR [Hospital] Outpatient Quality SSI Supplemental Security Income MDC Major diagnostic category SSO Short-stay outlier Reporting MDH Medicare-dependent, small rural SUD Substance use disorder O.R. Operating room hospital TEFRA Tax Equity and Fiscal OSCAR Online Survey Certification and MedPAC Medicare Payment Advisory Responsibility Act of 1982, Public Law 97– Reporting [System] Commission 248 PAC Post-acute care MedPAR Medicare Provider Analysis and TEP Technical expert panel PAMA Protecting Access to Medicare Act of Review File THA/TKA Total hip arthroplasty/total knee 2014, Public Law 113–93 MEI Medicare Economic Index arthroplasty PCH PPS-exempt cancer hospital MGCRB Medicare Geographic Classification TMA TMA [Transitional Medical PCHQR PPS-exempt cancer hospital quality Review Board Assistance], Abstinence Education, and QI reporting MIEA–TRHCA Medicare Improvements and [Qualifying Individuals] Programs PMSAs Primary metropolitan statistical Extension Act, Division B of the Tax Relief Extension Act of 2007, Public Law 110–90 areas and Health Care Act of 2006, Public Law TPS Total Performance Score POA Present on admission 109–432 UHDDS Uniform hospital discharge data set PPI Producer price index MIPPA Medicare Improvements for Patients UR Utilization review and Providers Act of 2008, Public Law PPR Potentially Preventable Readmissions VBP [Hospital] Value Based Purchasing 110–275 PPS Prospective payment system [Program] MMA Medicare Prescription Drug, PRA Paperwork Reduction Act VTE Venous thromboembolism PRM Provider Reimbursement Manual Improvement, and Modernization Act of ProPAC Prospective Payment Assessment Table of Contents 2003, Public Law 108–173 Commission MMEA Medicare and Medicaid Extenders I. Executive Summary and Background Act of 2010, Public Law 111–309 PRRB Provider Reimbursement Review A. Executive Summary MMSEA Medicare, Medicaid, and SCHIP Board 1. Purpose and Legal Authority Extension Act of 2007, Public Law 110–173 PRTFs Psychiatric residential treatment 2. Summary of the Major Provisions MOON Medicare Outpatient Observation facilities 3. Summary of Costs and Benefits Notice PSF Provider-Specific File B. Summary MRHFP Medicare Rural Hospital Flexibility PSI Patient safety indicator 1. Acute Care Hospital Inpatient Program PS&R Provider Statistical and Prospective Payment System (IPPS) MRSA Methicillin-resistant Staphylococcus Reimbursement [System] 2. Hospitals and Hospital Units Excluded aureus PQRS Physician Quality Reporting System From the IPPS MSA Metropolitan Statistical Area PUF Public use file 3. Long-Term Care Hospital Prospective MS–DRG Medicare severity diagnosis- QDM Quality data model Payment System (LTCH PPS) related group QIES ASAP Quality Improvement 4. Critical Access Hospitals (CAHs) MS–LTC–DRG Medicare severity long-term Evaluation System Assessment Submission 5. Payments for Graduate Medical care diagnosis-related group and Processing Education (GME) MU Meaningful Use [EHR Incentive QIG Quality Improvement Group [CMS] C. Summary of Provisions of Recent Program] QIO Quality Improvement Organization Legislation Implemented in This Final MUC Measure under consideration QM Quality measure Rule NAICS North American Industrial QRDA Quality Reporting Document 1. American Taxpayer Relief Act of 2012 Classification System Architecture (ATRA) (Pub. L. 112–240) NALTH National Association of Long Term RFA Regulatory Flexibility Act, Public Law 2. Pathway for SGR Reform Act of 2013 Hospitals 96–354 (Pub. L. 113–67) ES2 NCD National coverage determination RHC Rural health clinic 3. Improving Medicare Post-Acute Care RUL NCHS National Center for Health Statistics RHQDAPU Reporting hospital quality data Transformation Act of 2014 (IMPACT with NCQA National Committee for Quality for annual payment update Act) (Pub. L. 113–185) D Assurance RIM Reference information model 4. The Medicare Access and CHIP O PR NCVHS National Committee on Vital and RNHCI Religious nonmedical health care Reauthorization Act (MACRA) of 2015 T082 Health Statistics institution (Public Law 114–10) G9 NECMA New England County Metropolitan RPL Rehabilitation psychiatric long-term 5. The Consolidated Appropriations Act, SK3 Areas care (hospital) 2016 (Public Law 114–113) D mstockstill on VerDate Sep<11>2014 20:18 Aug 19, 2016 Jkt 238001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 E:\FR\FM\22AUR2.SGM 22AUR2 Federal Register/Vol. 81, No. 162/Monday, August 22, 2016/Rules and Regulations 56765 6. The Notice of Observation Treatment b. Pulmonary Embolism With tPA or Other a. Background of the CC List and the CC and Implication for Care Eligibility Act Thrombolytic Therapy Exclusions List (the NOTICE Act) of 2015 (Public Law 5. MDC 5 (Diseases and Disorders of the b. CC Exclusions List for FY 2017 114–42) Circulatory System) 16. Review of Procedure Codes in MS D. Issuance of Notice of Proposed a. Implant of Loop Recorder DRGs 981 Through 983; 984 Through Rulemaking b. Endovascular Thrombectomy of the 986; and 987 Through 989 E. Finalization of Interim Final Rule With Lower Limbs a. Moving Procedure Codes From MS– Comment Period on the Temporary c. Pacemaker Procedures Code DRGs 981 Through 983 or MS–DRGs 987 Exception to the Site Neutral Payment Combinations Through 989 Into MDCs Rate Under the LTCH PPS for Certain d. Transcatheter Mitral Valve Repair With b. Reassignment of Procedures Among MS– Severe Wound Discharges From Certain Implant DRGs 981 Through 983, 984 Through LTCHs as Required by the Consolidated e. MS–DRG 245 (AICD Generator 986, and 987 Through 989 Appropriations Act, 2016; and Procedures) c. Adding Diagnosis or Procedure Codes to Modification of Limitation on 6. MDC 6 (Diseases and Disorders of the MDCs Redesignation by the Medicare Digestive System): Excision of Ileum (1) Angioplasty of Extracranial Vessel Geographic Classification Review Board 7. MDC 7 (Diseases and Disorders of the (2) Excision of Abdominal Arteries G. Finalization of Interim Final Rule With Hepatobiliary System and Pancreas): (3) Excision of Retroperitoneal Tissue Comment Period on Medicare Dependent Bypass Procedures of the Veins (4) Occlusion of Vessels: Esophageal Small Rural Hospital Program and 8. MDC 8 (Diseases and Disorders of the Varices Payment to Low-Volume Hospitals Musculoskeletal System and Connective (5) Excision of Vulva II. Changes to Medicare Severity Diagnosis- Tissue) (6) Lymph Node Biopsy Related Group (MS–DRG) Classifications a. Updates to MS–DRGs 469 and 470 (7) Obstetrical Laceration Repair and Relative Weights (Major Joint Replacement or 17. Changes to the ICD–10–CM and ICD– A. Background Reattachment of Lower Extremity With 10–PCS Coding Systems B. MS–DRG Reclassifications and Without MCC, Respectively) a. ICD–10 Coordination and Maintenance C. Adoption of the MS–DRGs in FY 2008 (1) Total Ankle Replacement (TAR) Committee D. FY 2017 MS–DRG Documentation and Procedures b. Code Freeze Coding Adjustment (2) Hip Replacements Procedures With 18. Replaced Devices Offered Without Cost 1. Background on the Prospective MS–DRG Principal Diagnosis of Hip Fracture or With a Credit Documentation and Coding Adjustments b. Revision of Total Ankle Replacement a. Background for FY 2008 and FY 2009 Authorized by Procedures b. Changes for FY 2017 Public Law 110–90 (1) Revision of Total Ankle Replacement 19. Other Policy Changes 2. Adjustment to the Average Standardized Procedures a. MS–DRG GROUPER Logic Amounts Required by Public Law 110– (2) Combination Codes for Removal and (1) Operations on Products of Conception 90 Replacement of Knee Joints (2) Other Heart Revascularization a. Prospective Adjustment Required by c. Decompression Laminectomy (3) Procedures on Vascular Bodies: Section 7(b)(1)(A) of Public Law 110–90 d. Lordosis Chemoreceptors b. Recoupment or Repayment Adjustments 9. MDC 13 (Diseases and Disorders of the (4) Repair of the Intestine in FYs 2010 Through 2012 Required by Female Reproductive System): Pelvic (5) Insertion of Infusion Pump Section 7(b)(1)(B) of Public Law 110–90 Evisceration (6) Procedures on the Bursa 3. Retrospective Evaluation of FY 2008 and 10. MDC 19 (Mental Diseases and (7) Procedures on the Breast FY 2009 Claims Data Disorders): Modification of Title of MS– (8) Excision of Subcutaneous Tissue and 4. Prospective Adjustments for FY 2008 DRG 884 (Organic Disturbances and Fascia and FY 2009 Authorized by Section Mental Retardation) (9) Shoulder Replacement 7(b)(1)(A) of Public Law 110–90 11. MDC 23 (Factors Influencing Health (10) Reposition 5. Recoupment or Repayment Adjustment Status and Other Contacts With Health (11) Insertion of Infusion Device Authorized by Section 7(b)(1)(B) of Services): Logic of MS–DRGs 945 and (12) Bladder Neck Repair Public Law 110–90 6. Recoupment or Repayment Adjustment 946 (Rehabilitation With and Without (13) Future Consideration Authorized by Section 631 of the CC/MCC, Respectively) b. Issues Relating to MS–DRG 999 American Taxpayer Relief Act of 2012 12. Medicare Code Editor (MCE) Changes (Ungroupable) (ATRA) a. Age Conflict Edit c. Other Operating Room (O.R.) and Non- E. Refinement of the MS–DRG Relative (1) Newborn Diagnosis Category O.R. Issues Weight Calculation (2) Pediatric Diagnosis Category (1) O.R. Procedures to Non-O.R. Procedures 1. Background b. Sex Conflict Edit (a) Endoscopic/Transorifice Insertion 2. Discussion of Policy for FY 2017 c. Non-Covered Procedure Edit (b) Endoscopic/Transorifice Removal F. Changes to Specific MS–DRG (1) Endovascular Mechanical (c) Tracheostomy Device Removal Classifications Thrombectomy (d) Endoscopic/Percutaneous Insertion 1. Discussion of Changes to Coding System (2) Radical Prostatectomy (e) Percutaneous Removal and Basis for MS–DRG Updates d. Unacceptable Principal Diagnosis Edit (f) Percutaneous Drainage a. Conversion of MS–DRGs to the (1) Liveborn Infant (g) Percutaneous Inspection International Classification of Diseases, (2) Multiple Gestation (h) Inspection Without Incision 10th Revision (ICD–10) (3) Supervision of High Risk Pregnancy (i) Dilation of Stomach b. Basis for FY 2017 MS–DRG Updates e. Other MCE Issues (j) Endoscopic/Percutaneous Occlusion 2. Pre-Major Diagnostic Category (Pre- (1) Procedure Inconsistent With Length of (k) Infusion Device MDC): Total Artificial Heart Stay Edit (2) Non-O.R. Procedures to O.R. Procedures Replacement (2) Maternity Diagnoses (a) Drainage of Pleural Cavity 3. MDC 1 (Diseases and Disorders of the (3) Manifestation Codes Not Allowed as (b) Drainage of Cerebral Ventricle Nervous System) Principal Diagnosis Edit 20. Out of Scope Public Comments ES2 a. Endovascular Embolization (Coiling) or (4) Questionable Admission Edit Received RUL Occlusion of Head and Neck Procedures (5) Removal of Edits and Future G. Recalibration of the FY 2017 MS–DRG with b. Mechanical Complication Codes Enhancement Relative Weights D 4. MDC 4 (Diseases and Disorders of the 13. Changes to Surgical Hierarchies 1. Data Sources for Developing the Relative O PR Ear, Nose, Mouth and Throat) 14. Changes to the MS–DRG Diagnosis Weights T082 a. Reassignment of Diagnosis Code R22.2 Codes for FY 2017 2. Methodology for Calculation of the G9 (Localized Swelling, Mass and Lump, 15. Complications or Comorbidity (CC) Relative Weights SK3 Trunk) Exclusions List 3. Development of National Average CCRs D mstockstill on VerDate Sep<11>2014 20:18 Aug 19, 2016 Jkt 238001 PO 00000 Frm 00005 Fmt 4701 Sfmt 4700 E:\FR\FM\22AUR2.SGM 22AUR2 56766 Federal Register/Vol. 81, No. 162/Monday, August 22, 2016/Rules and Regulations H. Add-On Payments for New Services and 4. Budget Neutrality 2. Other Policy Changes Affecting IME Technologies H. Application of the Rural, Imputed, and F. Payment Adjustment for Medicare 1. Background Frontier Floors Disproportionate Share Hospitals (DSHs) 2. Public Input Before Publication of a 1. Rural Floor for FY 2017 and Subsequent Years Notice of Proposed Rulemaking on Add- 2. Imputed Floor for FY 2017 (§412.106) On Payments 3. State Frontier Floor for FY 2017 1. General Discussion 3. ICD–10–PCS Section ‘‘X’’ Codes for I. FY 2017 Wage Index Tables 2. Eligibility for Empirically Justified Certain New Medical Services and J. Revisions to the Wage Index Based on Medicare DSH Payments and Technologies Hospital Redesignations and Uncompensated Care Payments 4. FY 2017 Status of Technologies Reclassifications 3. Empirically Justified Medicare DSH Approved for FY 2016 Add-On Payments 1. General Policies and Effects of Payments a. KcentraTM Reclassification and Redesignation 4. Uncompensated Care Payments b. Argus® II Retinal Prosthesis System 2. Finalization of Interim Final Rule With a. Calculation of Factor 1 for FY 2017 c. CardioMEMSTMHF (Heart Failure) Comment Period on Provisions Related b. Calculation of Factor 2 for FY 2017 Monitoring System to Modification on Limitations on c. Calculation of Factor 3 for FY 2017 d. MitraClip® System Redesignations by the Medicare d. Calculation of Factor 3 for FY 2018 and e. Responsive Neurostimulator (RNS® ) Geographic Classification Review Board Subsequent Fiscal Years System (MGCRB) (1) Background f. Blinatumomab (BLINCYTOTMTrade a. Background (2) Proposed and Finalized Data Source Brand) b. Criteria for an Individual Hospital and Time Period for FY 2018 and g. Lutonix® Drug Coated Balloon PTA Seeking Redesignation to Another Area Subsequent Years, Including Catheter and In.PACTTMAdmiralTM (§412.103)—Application of Policy Methodology for Incorporating Pacliaxel Coated Percutaneous Provisions Worksheet S–10 Data Transluminal Angioplasty (PTA) Balloon c. Final Rule Provisions (3) Definition of Uncompensated Care for Catheter d. Impact FY 2018 and Subsequent Fiscal Years 5. FY 2017 Applications for New 3. Other MGCRB Reclassification and (4) Other Methodological Considerations Technology Add-On Payments Redesignation Issues for FY 2017 for FY 2018 and Subsequent Fiscal Years a. MAGEC® Spinal Bracing and Distraction a. FY 2017 Reclassification Requirements G. Hospital Readmissions Reduction System (MAGEC® Spine) and Approvals Program: Updates and Changes b. MIRODERM Biologic Wound Matrix b. Requirements for FY 2018 Applications (§§412.150 Through 412.154) (MIRODERM) and Revisions Regarding Paper 1. Statutory Basis for the Hospital c. Idarucizumab d. Titan Spine (Titan Spine Endoskeleton® Application Requirements Readmissions Reduction Program c. Other Policy Regarding Reclassifications 2. Regulatory Background nanoLOCKTMInterbody Device) for Terminated Hospitals 3. Policies for the FY 2017 Hospital e. Defitelio® (Defibrotide) 4. Redesignation of Hospitals Under Readmissions Reduction Program f. GORE® EXCLUDER® Iliac Branch Section 1886(d)(8)(B) of the Act 4. Maintenance of Technical Specifications Endoprosthesis (IBE) 5. Waiving Lugar Redesignation for the for Quality Measures g VistogardTM(Uridine Triacetate) Out-Migration Adjustment 5. Applicable Period for FY 2017 III. Changes to the Hospital Wage Index for K. Out-Migration Adjustment Based on 6. Calculation of Aggregate Payments for Acute Care Hospitals Commuting Patterns of Hospital Excess Readmissions for FY 2017 A. Background Employees for FY 2017 7. Extraordinary Circumstance Exception 1. Legislative Authority L. Notification Regarding CMS ‘‘Lock-In’’ Policy 2. Core-Based Statistical Areas (CBSAs) Date for Urban to Rural Reclassifications 8. Timeline for Public Reporting of Excess Revisions for the FY 2017 Hospital Wage Under §412.103 Readmission Ratios on Hospital Index M. Process for Requests for Wage Index Compare for the FY 2017 Payment B. Worksheet S–3 Wage Data for the FY Data Corrections Determination 2017 Wage Index N. Labor Market Share for the FY 2017 H. Hospital Value-Based Purchasing (VBP) 1. Included Categories of Costs 2. Excluded Categories of Costs Wage Index Program: Policy Changes for the FY 2018 3. Use of Wage Index Data by Suppliers O. Public Comments on Treatment of Program Year and Subsequent Years and Providers Other Than Acute Care Overhead and Home Office Costs in the 1. Background Hospitals Under the IPPS Wage Index Calculation as a Result of a. Statutory Background and Overview of C. Verification of Worksheet S–3 Wage Our Solicitation Past Program Years Data IV. Other Decisions and Changes to the IPPS b. FY 2017 Program Year Payment Details D. Method for Computing the FY 2017 for Operating Costs and Graduate 2. PSI 90 Measure in the FY 2018 Program Unadjusted Wage Index Medical Education (GME) Costs and Future Program Years E. Occupational Mix Adjustment to the FY A. Changes to Operating Payments for a. PSI 90 Measure Performance Period 2017 Wage Index Subsection (d) Puerto Rico Hospitals as Change for the FY 2018 Program Year 1. Use of 2013 Occupational Mix Survey a Result of Section 601 of Pub. L. 114– b. Intent To Propose in Future Rulemaking for the FY 2017 Wage Index 113 To Adopt the Modified PSI 90 Measure 2. Development of the 2016 Medicare Wage B. Changes in the Inpatient Hospital 3. Retention Policy, Domain Name Change, Index Occupational Mix Survey for the Updates for FY 2017 (§§412.64(d) and and Updating of Quality Measures for FY 2019 Wage Index 412.211(c)) the FY 2019 Program Year 3. Calculation of the Occupational Mix 1. FY 2017 Inpatient Hospital Update a. Retention of Previously Adopted Adjustment for FY 2017 2. FY 2017 Puerto Rico Hospital Update Hospital VBP Program Measures F. Analysis and Implementation of the 3. Electronic Health Records (EHR) b. Domain Name Change Occupational Mix Adjustment and the Adjustment to IPPS Market Basket c. Inclusion of Selected Ward Non- FY 2017 Occupational Mix Adjusted C. Rural Referral Centers (RRCs): Annual Intensive Care Unit (ICU) Locations in Wage Index Updates to Case-Mix Index (CMI) and Certain NHSN Measures Beginning With ES2 G. Transitional Wage Indexes Discharge Criteria (§412.96) the FY 2019 Program Year RUL 1. Background 1. Case-Mix Index (CMI) d. Summary of Previously Adopted with 2. Transition for Hospitals in Urban Areas 2. Discharges Measures and Newly Finalized Measure D That Became Rural D. Payment Adjustment for Low-Volume Refinements for the FY 2019 Program O PR 3. Transition for Hospitals Deemed Urban Hospitals (§412.101) Year T082 Under Section 1886(d)(8)(B) of the Act E. Indirect Medical Education (IME) 4. Finalized Measures and Measure G9 Where the Urban Area Became Rural Payment Adjustment (§412.105) Refinements for the FY 2021 Program SK3 Under the New OMB Delineations 1. IME Adjustment Factor for FY 2017 Year and Subsequent Years D mstockstill on VerDate Sep<11>2014 20:18 Aug 19, 2016 Jkt 238001 PO 00000 Frm 00006 Fmt 4701 Sfmt 4700 E:\FR\FM\22AUR2.SGM 22AUR2 Federal Register/Vol. 81, No. 162/Monday, August 22, 2016/Rules and Regulations 56767 a. Condition-Specific Hospital Level, Risk- c. Changes to the HAC Reduction Program 6. Technical Correction to 42 CFR Standardized Payment Measures Scoring Methodology 413.200(c)(1)(i) Relating to Medicare b. Finalized Update to an Existing Measure 4. Comments on Additional Measures for Cost Report Due Dates for Organ for the FY 2021 Program Year: Hospital Potential Future Adoption Procurement Organizations and 30-Day, All-Cause, Risk-Standardized 5. Maintenance of Technical Specifications Histocompatibility Laboratories Mortality Rate (RSMR) Following for Quality Measures N. Finalization of Interim Final Rule With Pneumonia (PN) Hospitalization (NQF 6. Extraordinary Circumstance Exception Comment Period Implementing #0468) (Updated Cohort) Policy for the HAC Reduction Program Legislative Extensions Relating to the 5. New Measure for the FY 2022 Program Beginning in FY 2016 and for Payment Adjustments for Low-Volume Year: Hospital 30-Day, All-Cause, Risk- Subsequent Years Hospitals and the Medicare-Dependent, Standardized Mortality Rate (RSMR) J. Payment for Graduate Medical Education Small Rural Hospital (MDH) Program Following Coronary Artery Bypass Graft (GME) and Indirect Medical Education O. Clarification Regarding the Medicare (CABG) Surgery (NQF #2558) (IME) Costs (§§412.105, 413.75 Through Utilization Requirement for Medicare- 6. Previously Adopted and Newly 413.83) Dependent, Small Rural Hospitals Finalized Baseline and Performance 1. Background (MDHs) (§412.108) Periods 2. Change in New Program Growth From 3 P. Adjustment to IPPS Rates Resulting a. Background Years to 5 Years From 2-Midnight Policy b. Patient- and Caregiver-Centered a. Urban and Rural Hospitals V. Changes to the IPPS for Capital-Related Experience of Care/Care Coordination b. Policy Changes Relating to Rural Costs Domain (Person and Community Training Tracks at Urban Hospitals A. Overview Engagement Domain Beginning With the c. Effective Date B. Additional Provisions FY 2019 Program Year) 3. Section 5506 Closed Hospitals 1. Exception Payments c. Efficiency and Cost Reduction Domain K. Rural Community Hospital 2. New Hospitals d. Safety Domain Demonstration Program 3. Changes in Payments for Hospitals e. Clinical Care Domain 1. Background Located in Puerto Rico f. Summary of Previously Adopted and 2. Budget Neutrality Offset Adjustments: C. Annual Update for FY 2017 Newly Finalized Baseline and Fiscal Years 2005 Through 2016 VI. Changes for Hospitals Excluded From the Performance Periods for the FY 2018, FY a. Fiscal Years 2005 Through 2013 IPPS 2019, FY 2020, FY 2021, and FY 2022 b. Fiscal Years 2014 and 2015 A. Rate-of-Increase in Payments to Program Years c. Fiscal Year 2016 Excluded Hospitals for FY 2017 7. Immediate Jeopardy Policy Changes 3. Budget Neutrality Methodology for FY B. Report of Adjustment (Exceptions) a. Background 2017 and Reconciliation for FYs 2011 Payments b. Increase of Immediate Jeopardy Citations Through 2016 C. Critical Care Hospitals (CAHs) From Two to Three Surveys a. Budget Neutrality Methodology for FY 1. Background c. EMTALA-Related Immediate Jeopardy 2017 2. Frontier Community Health Integration Citations b. Budget Neutrality Offset Reconciliation Project (FCHIP) Demonstration 8. Performance Standards for the Hospital for FYs 2011 Through 2016 VII. Changes to the Long-Term Care Hospital VBP Program L. Hospital and CAH Notification Prospective Payment System (LTCH PPS) a. Background Procedures for Outpatients Receiving for FY 2017 b. Previously Adopted and Newly Observation Services A. Background of the LTCH PPS Finalized Performance Standards for the 1. Background 1. Legislative and Regulatory Authority FY 2019 Program Year a. Statutory Authority 2. Criteria for Classification as a LTCH c. Previously Adopted Performance b. Effective Date a. Classification as a LTCH Standards for Certain Measures for the 2. Implementation of the NOTICE Act b. Hospitals Excluded From the LTCH PPS FY 2020 Program Year Provisions 3. Limitation on Charges to Beneficiaries d. Previously Adopted and Newly a. Notice Process 4. Administrative Simplification Finalized Performance Standards for b. Notification Recipients Compliance Act (ASCA) and Health Certain Measures for the FY 2021 c. Timing of Notice Delivery Program Year d. Requirements for Written Notice Insurance Portability and Accountability e. Performance Standards for Certain e. Outpatient Observation Services and Act (HIPAA) Compliance Measures for the FY 2022 Program Year Beneficiary Financial Liability B. Modifications to the Application of the 9. FY 2019 Program Year Scoring f. Delivering the Medicare Outpatient Site Neutral Payment Rate (§412.522) Methodology Observation Notice 1. Background a. Domain Weighting for the FY 2019 g. Oral Notice 2. Technical Correction of Definition of Program Year for Hospitals That Receive h. Signature Requirements ‘‘Subsection (d) Hospital’’ for the Site a Score on All Domains i. No Appeal Rights Under the NOTICE Act Neutral Payment Rate (§412.503) b. Domain Weighting for the FY 2019 M. Technical Changes and Correction of 3. Finalization of Interim Final Rule With Program Year for Hospitals Receiving Typographical Errors in Certain Comment Period: Temporary Exception Scores on Fewer Than Four Domains Regulations Under 42 CFR Part 413 to the Site Neutral Payment Rate Under I. Changes to the Hospital-Acquired Relating to Costs to Related the LTCH PPS for Certain Severe Wound Condition (HAC) Reduction Program Organizations and Medicare Cost Reports Discharges From Certain LTCHs 1. Background 1. General Background C. Medicare Severity Long-Term Care 2. Implementation of the HAC Reduction 2. Technical Change to Regulations at 42 Diagnosis-Related Group (MS–LTC– Program for FY 2017 CFR 413.17(d)(1) on Cost to Related DRG) Classifications and Relative a. Clarification of Complete Data Organizations Weights for FY 2017 Requirements for Domain 1 3. Changes to 42 CFR 413.24(f)(4)(i) 1. Background b. Clarification of NHSN CDC HAI Data Relating to Electronic Submission of Cost 2. Patient Classifications Into MS–LTC– Submission Requirements for Newly Reports DRGs Opened Hospitals 4. Technical Changes to 42 CFR a. Background ES2 3. Implementation of the HAC Reduction 413.24(f)(4)(ii) Relating to Electronic b. Changes to the MS–LTC–DRGs for FY RUL Program for FY 2018 Submission of Cost Reports and Due 2017 with a. Adoption of Modified PSI 90: Patient Dates 3. Development of the FY 2017 MS–LTC– D Safety and Adverse Events Composite 5. Technical Changes to 42 CFR DRG Relative Weights O PR (NQF #0531) 413.24(f)(4)(iv) Relating to Reporting a. General Overview of the Development of T082 b. Applicable Time Periods for the FY 2018 Entities, Cost Report Certification the MS–LTC–DRG Relative Weights G9 HAC Reduction Program and the FY Statement, Electronic Submission and b. Development of the MS–LTC–DRG SK3 2019 HAC Reduction Program Cost Reports Due Dates Relative Weights for FY 2017 D mstockstill on VerDate Sep<11>2014 20:18 Aug 19, 2016 Jkt 238001 PO 00000 Frm 00007 Fmt 4701 Sfmt 4700 E:\FR\FM\22AUR2.SGM 22AUR2 56768 Federal Register/Vol. 81, No. 162/Monday, August 22, 2016/Rules and Regulations c. Data b. Market Basket Under the LTCH PPS for c. Clarification Regarding Data Submission d. Hospital-Specific Relative Value (HSRV) FY 2017 for ED–1, ED–2, PC–01, STK–4, VTE–5, Methodology c. Revision of Certain Market Basket and VTE–6 e. Treatment of Severity Levels in Updates as Required by the Affordable 9. Possible New Quality Measures and Developing the MS–LTC–DRG Relative Care Act Measure Topics for Future Years Weights d. Adjustment to the LTCH PPS Standard a. Potential Inclusion of the National f. Low-Volume MS–LTC–DRGs Federal Payment Rate Under the Long- Institutes of Health (NIH) Stroke Scale g. Steps for Determining the FY 2017 MS– Term Care Hospital Quality Reporting for the Hospital 30-Day Mortality LTC–DRG Relative Weights Program (LTCH QRP) Following Acute Ischemic Stroke D. Rebasing of the LTCH Market Basket e. Annual Market Basket Update Under the Hospitalization Measure Beginning as 1. Background LTCH PPS for FY 2017 Early as the FY 2022 Payment 2. Overview of the 2013-Based LTCH 3. Update Under the Payment Adjustment Determination Market Basket for ‘‘Subclause (II)’’ LTCHs b. Potential Inclusion of National 3. Development of the 2013-Based LTCH F. Modifications to the ‘‘25-Percent Healthcare Safety Network (NHSN) Market Basket Cost Categories and Threshold Policy’’ Payment Adjustments Antimicrobial Use Measure (NQF #2720) Weights (§§412.534 and 412.536) c. Potential Measures for Behavioral Health a. Use of Medicare Cost Report Data G. Refinement to the Payment Adjustment in the Hospital IQR Program (1) Wages and Salaries Costs for ‘‘Subclause II’’ LTCHs d. Potential Public Reporting of Quality (2) Employee Benefit Costs VIII. Quality Data Reporting Requirements for Measures Data Stratified by Race, (3) Contract Labor Costs Specific Providers and Suppliers Ethnicity, Sex, and Disability and Future (4) Pharmaceutical Costs A. Hospital Inpatient Quality Reporting Hospital Quality Measures That (5) Professional Liability Insurance Costs (IQR) Program Incorporate Health Equity (6) Capital Costs 1. Background 10. Form, Manner, and Timing of Quality b. Final Major Cost Category Computation a. History of the Hospital IQR Program Data Submission c. Derivation of the Detailed Operating Cost b. Maintenance of Technical Specifications a. Background b. Procedural Requirements for the FY Weights for Quality Measures 2019 Payment Determination and d. Derivation of the Detailed Capital Cost c. Public Display of Quality Measures Subsequent Years Weights 2. Process for Retaining Previously c. Data Submission Requirements for e. 2013-Based LTCH Market Basket Cost Adopted Hospital IQR Program Measures Chart-Abstracted Measures Categories and Weights for Subsequent Payment Determinations d. Alignment of the Hospital IQR Program 4. Selection of Price Proxies 3. Removal and Suspension of Hospital With the Medicare and Medicaid EHR a. Price Proxies for the Operating Portion IQR Program Measures Incentive Programs for Eligible Hospitals of the 2013-Based LTCH Market Basket a. Considerations in Removing Quality and CAHs (1) Wages and Salaries Measures From the Hospital IQR e. Sampling and Case Thresholds for the (2) Employee Benefits Program FY 2019 Payment Determination and (3) Electricity b. Removal of Hospital IQR Program Subsequent Years (4) Fuel, Oil, and Gasoline Measures for the FY 2019 Payment f. HCAHPS Requirements for the FY 2019 (5) Water and Sewage Determination and Subsequent Years Payment Determination and Subsequent (6) Professional Liability Insurance 4. Previously Adopted Hospital IQR Years (7) Pharmaceuticals Program Measures for the FY 2018 g. Data Submission Requirements for (8) Food: Direct Purchases Payment Determination and Subsequent Structural Measures for the FY 2019 (9) Food: Contract Services Years Payment Determination and Subsequent (10) Chemicals 5. Expansion and Updating of Quality Years (11) Medical Instruments Measures h. Data Submission and Reporting (12) Rubber and Plastics 6. Refinements to Existing Measures in the Requirements for HAI Measures (13) Paper and Printing Products Hospital IQR Program Reported via NHSN (14) Miscellaneous Products a. Expansion of the Cohort for the PN 11. Modifications to the Existing Processes (15) Professional Fees: Labor-Related Payment Measure: Hospital-Level, Risk- for Validation of Hospital IQR Program (16) Administrative and Facilities Support Standardized Payment Associated With a Data Services 30-Day Episode-of-Care for Pneumonia a. Background (17) Installation, Maintenance, and Repair (NQF #2579) b. Modifications to the Existing Processes Services b. Adoption of Modified PSI 90: Patient for Validation of Hospital IQR Program (18) All Other: Labor-Related Services Safety and Adverse Events Composite Data (19) Professional Fees: Nonlabor-Related Measure (NQF #0531) 12. Data Accuracy and Completeness (20) Financial Services 7. Additional Hospital IQR Program Acknowledgement (DACA) (21) Telephone Services Measures for the FY 2019 Payment Requirements for the FY 2019 Payment (22) All Other: Nonlabor-Related Services Determinations and Subsequent Years Determination and Subsequent Years b. Price Proxies for the Capital Portion of a. Adoption of Three Clinical Episode- 13. Public Display Requirements for the FY the 2013-Based LTCH Market Basket Based Payment Measures 2019 Payment Determination and (1) Capital Price Proxies Prior to Vintage b. Adoption of Excess Days in Acute Care Subsequent Years Weighting After Hospitalization for Pneumonia (PN 14. Reconsideration and Appeal (2) Vintage Weights for Price Proxies Excess Days) Measure Procedures for the FY 2019 Payment c. Summary of Price Proxies of the 2013- c. Summary of Previously Adopted and Determination and Subsequent Years Based LTCH Market Basket Newly Finalized Hospital IQR Program 15. Changes to the Hospital IQR Program d. FY 2017 Market Basket Update for Measures for the FY 2019 Payment Extraordinary Circumstances Extensions LTCHs Determination and Subsequent Years or Exemptions (ECE) Policy e. FY 2017 Labor-Related Share 8. Changes to Policies on Reporting of a. Extension of the General ECE Request E. Changes to the LTCH PPS Payment Rates eCQMs Deadline for Non-eCQM Circumstances ES2 and Other Changes to the LTCH PPS for a. Requirement That Hospitals Report on b. Establishment of a Separate Submission RUL FY 2017 an Increased Number of eCQMs in the Deadline for ECE Requests Related to with 1. Overview of Development of the LTCH Hospital IQR Program Measure Set for eCQMs D PPS Standard Federal Payment Rates the CY 2017 Reporting Period/FY 2019 B. PPS-Exempt Cancer Hospital Quality O PR 2. FY 2017 LTCH PPS Standard Federal Payment Determination and Subsequent Reporting (PCHQR) Program T082 Payment Rate Annual Market Basket Years 1. Background G9 Update b. Requirement That Hospitals Report a 2. Criteria for Removal and Retention of SK3 a. Overview Full Year of eCQM Data PCHQR Program Measures D mstockstill on VerDate Sep<11>2014 20:18 Aug 19, 2016 Jkt 238001 PO 00000 Frm 00008 Fmt 4701 Sfmt 4700 E:\FR\FM\22AUR2.SGM 22AUR2 Federal Register/Vol. 81, No. 162/Monday, August 22, 2016/Rules and Regulations 56769 3. Retention and Update to Previously Payment Determination and Subsequent 8. Form, Manner, and Timing of Quality Finalized Quality Measures for PCHs Years Data Submission Beginning With the FY 2019 Program a. Background a. Procedural and Submission Year b. Timeline for Data Submission Under the Requirements a. Background LTCH QRP for the FY 2018 Payment b. Change to the Reporting Periods and b. Update of Oncology: Radiation Dose Determination and Subsequent Years Submission Timeframes Limits to Normal Tissues (NQF #0382) c. Timeline and Data Submission c. Population and Sampling Measure for FY 2019 Program Year and Mechanisms for the FY 2018 Payment d. Data Accuracy and Completeness Subsequent Years Determination and Subsequent Years for Acknowledgement (DACA) 4. New Quality Measure Beginning With the LTCH QRP Resource Use and Other Requirements the FY 2019 Program Year Measures—Claims-Based Measures 9. Reconsideration and Appeals Procedures a. Considerations in the Selection of d. Revisions to the Previously Adopted 10. Exceptions to Quality Reporting Quality Measures Data Collection Period and Submission Requirements b. Adoption of the Admissions and Deadlines for Percent of Residents or E. Clinical Quality Measurement for Emergency Department (ED) Visits for Patients Who Were Assessed and Eligible Hospitals and Critical Access Patients Receiving Outpatient Appropriately Given the Seasonal Hospitals (CAHs) Participating in the Chemotherapy Measure Influenza Vaccine (Short Stay) (NQF EHR Incentive Programs in 2017 5. Possible New Quality Measure Topics #0680) for the FY 2019 Payment 1. Background for Future Years Determination and Subsequent Years 2. CQM Reporting for the Medicare and 6. Maintenance of Technical Specifications e. Timeline and Data Submission Medicaid EHR Incentive Programs in for Quality Measures Mechanisms for the Newly Finalized 2017 7. Public Display Requirements LTCH QRP Quality Measure for the FY a. Background 2020 Payment Determination and a. Background b. Additional Public Display Requirements Subsequent Years b. CQM Reporting Period for the Medicare c. Public Display of Additional PCHQR 10. LTCH QRP Data Completion and Medicaid EHR Incentive Programs in Thresholds for the FY 2016 Payment CY 2017 Measure Determination and Subsequent Years c. CQM Reporting Form and Method for d. Public Display of Updated Measure 11. LTCH QRP Data Validation Process for the Medicare EHR Incentive Program in e. Postponement of Public Display of Two the FY 2016 Payment Determination and 2017 Measures Subsequent Years IX. MedPAC Recommendations 8. Form, Manner, and Timing of Data 12. Change to Previously Codified LTCH X. Other Required Information Submission QRP Submission Exception and A. Requests for Data From the Public 9. Exceptions From PCHQR Program Extension Policies B. Collection of Information Requirements Requirements 13. Previously Finalized LTCH QRP 1. Statutory Requirement for Solicitation of C. Long-Term Care Hospital Quality Reconsideration and Appeals Procedures Comments Reporting Program (LTCH QRP) 14. Policies Regarding Public Display of 2. ICRs for Add-On Payments for New 1. Background and Statutory Authority Measure Data for the LTCH QRP and Services and Technologies 2. General Considerations Used for Procedures for the Opportunity To 3. ICRs for the Occupational Mix Selection of Quality, Resource Use, and Review and Correct Data and Adjustment to the FY 2017 Wage Index Other Measures for the LTCH QRP Information (Hospital Wage Index Occupational Mix 3. Policy for Retention of LTCH QRP a. Public Display of Measures Survey) Measures Adopted for Previous Payment b. Procedures for the Opportunity To 4. Hospital Applications for Geographic Determinations Review and Correct Data and Reclassifications by the MGCRB 4. Policy for Adopting Changes to LTCH Information 5. ICRs for Applications for GME Resident QRP Measures 15. Mechanism for Providing Feedback Slots 5. Quality Measures Previously Finalized Reports to LTCHs 6. ICRs for the Notice of Observation for and Currently Used in the LTCH QRP D. Inpatient Psychiatric Facility Quality Treatment by Hospitals and CAHs 6. LTCH QRP Quality, Resource Use and Reporting (IPFQR) Program 7. ICRs for the Hospital Inpatient Quality Other Measures for the FY 2018 Payment 1. Background Reporting (IQR) Program Determination and Subsequent Years a. Statutory Authority 8. ICRs for PPS-Exempt Cancer Hospital a. Measure To Address the IMPACT Act b. Covered Entities Quality Reporting (PCHQR) Program Domain of Resource Use and Other c. Considerations in Selecting Quality 9. ICRs for Hospital Value-Based Measures: Total Estimated MSPB—PAC Measures Purchasing (VBP) Program LTCH QRP 2. Retention of IPFQR Program Measures 10. ICRs for the Long-Term Care Hospital b. Measure To Address the IMPACT Act Adopted in Previous Payment Quality Reporting Program (LTCH QRP) Domain of Resource Use and Other Determinations 11. ICRs for the Inpatient Psychiatric Measures: Discharge to Community-Post 3. Update to Previously Finalized Measure: Facility Quality Reporting (IPFQR) Acute Care (PAC) LTCH QRP Screening for Metabolic Disorders Program c. Measure To Address the IMPACT Act 4. New Quality Measures for the FY 2019 12. ICRs for the Electronic Health Record Domain of Resource Use and Other Payment Determination and Subsequent (EHR) Incentive Programs and Measures: Potentially Preventable 30- Years Meaningful Use Day Post-Discharge Readmission a. SUB–3—Alcohol and Other Drug Use Measure for the LTCH QRP Disorder Treatment Provided or Offered Regulation Text 7. LTCH QRP Quality Measure Finalized at Discharge and the Subset Measure Addendum—Schedule of Standardized for the FY 2020 Payment Determination SUB–3a—Alcohol and Other Drug Use Amounts, Update Factors, and Rate-of- and Subsequent Years Disorder Treatment at Discharge (NQF Increase Percentages Effective With Cost a. Background #1664) (SUB–3 and SUB3a) Reporting Periods Beginning on or after b. Measure To Address the IMPACT Act b. Thirty-Day All-Cause Unplanned October 1, 2016 and Payment Rates for Domain of Medication Reconciliation: Readmission Following Psychiatric ES2 Drug Regimen Review Conducted With Hospitalization in an IPF LTCHs Effective With Discharges Occurring RUL Follow-Up for Identified Issues-Post 5. Summary of Measures for the FY 2019 on or After October 1, 2016 with Acute Care LTCH QRP Payment Determination and Subsequent I. Summary and Background D 8. LTCH QRP Quality Measures and Years II. Changes to the Prospective Payment Rates O PR Measure Concepts Under Consideration 6. Possible IPFQR Program Measures and for Hospital Inpatient Operating Costs for T082 for Future Years Topics for Future Consideration Acute Care Hospitals for FY 2017 G9 9. Form, Manner, and Timing of Quality 7. Public Display and Review A. Calculation of the Adjusted SK3 Data Submission for the FY 2018 Requirements Standardized Amount D mstockstill on VerDate Sep<11>2014 20:18 Aug 19, 2016 Jkt 238001 PO 00000 Frm 00009 Fmt 4701 Sfmt 4700 E:\FR\FM\22AUR2.SGM 22AUR2 56770 Federal Register/Vol. 81, No. 162/Monday, August 22, 2016/Rules and Regulations B. Adjustments for Area Wage Levels and 4. Effects of Changes Under the FY 2017 III. Secretary’s Recommendation Cost-of-Living Hospital Value-Based Purchasing (VBP) IV. MedPAC Recommendation for Assessing C. Calculation of the Prospective Payment Program Payment Adequacy and Updating Rates 5. Effects of the Changes to the HAC Payments in Traditional Medicare III. Changes to Payment Rates for Acute Care Reduction Program for FY 2017 I. Executive Summary and Background Hospital Inpatient Capital-Related Costs 6. Effects of Policy Changes Relating to for FY 2017 Direct GME and IME Payments for Rural A. Executive Summary A. Determination of Federal Hospital Training Tracks at Urban Hospitals Inpatient Capital-Related Prospective 7. Effects of Implementation of Rural 1. Purpose and Legal Authority Payment Rate Update Community Hospital Demonstration This final rule makes payment and B. Calculation of the Inpatient Capital- Program policy changes under the Medicare Related Prospective Payments for FY 8. Effects of Implementation of the Notice inpatient prospective payment systems 2017 of Observation Treatment and C. Capital Input Price Index Implications for Care Eligibility Act (IPPS) for operating and capital-related IV. Changes to Payment Rates for Excluded (NOTICE Act) costs of acute care hospitals as well as Hospitals: Rate-of-Increase Percentages 9. Effects of Technical Changes and for certain hospitals and hospital units for FY 2017 Correction of Typographical Errors in excluded from the IPPS. In addition, it V. Updates to the Payment Rates for the Certain Regulations Under 42 CFR part makes payment and policy changes for LTCH PPS for FY 2017 413 Relating to Costs to Related inpatient hospital services provided by A. LTCH PPS Standard Federal Payment Organizations and Medicare Cost Reports long-term care hospitals (LTCHs) under Rate for FY 2017 10. Effects of Implementation of the the long-term care hospital prospective B. Adjustment for Area Wage Levels Under Frontier Community Health Integration payment system (LTCH PPS). It also the LTCH PPS for FY 2017 Project (FCHIP) Demonstration 1. Background I. Effects of Changes in the Capital IPPS makes policy changes to programs 2. Geographic Classifications (Labor Market 1. General Considerations associated with Medicare IPPS Areas) for the LTCH PPS Standard 2. Results hospitals, IPPS-excluded hospitals, and Federal Payment Rate J. Effects of Payment Rate Changes and LTCHs. 3. Labor-Related Share for the LTCH PPS Policy Changes Under the LTCH PPS We are establishing new requirements Standard Federal Payment Rate 1. Introduction and General Considerations or revising requirements for quality 4. Wage Index for FY 2017 for the LTCH 2. Impact on Rural Hospitals reporting by specific providers (acute PPS Standard Federal Payment Rate 3. Anticipated Effects of LTCH PPS care hospitals, PPS-exempt cancer 5. Budget Neutrality Adjustment for Payment Rate Changes and Policy hospitals, LTCHs, and inpatient Changes to the LTCH PPS Standard Changes Federal Payment Rate Area Wage Level 4. Effect on the Medicare Program psychiatric facilities) that are Adjustment 5. Effect on Medicare Beneficiaries participating in Medicare, including C. LTCH PPS Cost-of-Living Adjustment K. Effects of Requirements for Hospital related provisions for eligible hospitals (COLA) for LTCHs Located in Alaska and Inpatient Quality Reporting (IQR) and critical access hospitals (CAHs) Hawaii Program participating in the Electronic Health D. Adjustment for LTCH PPS High-Cost L. Effects of Requirements for the PPS- Record (EHR) Incentive Program. We are Outlier (HCO) Cases Exempt Cancer Hospital Quality updating policies relating to the E. Update to the IPPS Comparable/ Reporting (PCHQR) Program Hospital Value-Based Purchasing (VBP) Equivalent Amounts To Reflect the M. Effects of Requirements for the Long- Program, the Hospital Readmissions Statutory Changes to the IPPS DSH Term Care Hospital Quality Reporting Payment Adjustment Methodology Program (LTCH QRP) for the FY 2018 Reduction Program, and the Hospital- F. Computing the Adjusted LTCH PPS Payment Determination and Subsequent Acquired Condition (HAC) Reduction Federal Prospective Payments for FY Years Program. We are implementing statutory 2017 N. Effects of Updates to the Inpatient provisions that require hospitals and VI. Tables Referenced in This Final Rule and Psychiatric Facility Quality Reporting CAHs to furnish notification to Available Through the Internet on the (IPFQR) Program Medicare beneficiaries, including CMS Web site O. Effects of Requirements Regarding the Medicare Advantage enrollees, when Electronic Health Record (EHR) Appendix A—Economic Analyses the beneficiaries receive outpatient Incentive Programs and Meaningful Use I. Regulatory Impact Analysis P. Alternatives Considered observation services for more than 24 A. Introduction Q. Overall Conclusion hours; announcing the implementation B. Need 1. Acute Care Hospitals of the Frontier Community Health C. Objectives of the IPPS 2. LTCHs Integration Project Demonstration; and D. Limitations of Our Analysis II. Accounting Statements and Tables making technical corrections and E. Hospitals Included in and Excluded A. Acute Care Hospitals changes to regulations relating to costs From the IPPS B. LTCHs to organizations and Medicare cost F. Effects on Hospitals and Hospital Units III. Regulatory Flexibility Act (RFA) Analysis reports. In addition, in this final rule, Excluded From the IPPS IV. Impact on Small Rural Hospitals we are providing notice of the closure G. Quantitative Effects of the Policy V. Unfunded Mandate Reform Act (UMRA) Changes Under the IPPS for Operating Analysis of three teaching hospitals and the Costs VI. Executive Order 12866 opportunity for hospitals to apply for 1. Basis and Methodology of Estimates available graduate medical education Appendix B: Recommendation of Update 2. Analysis of Table I resident slots under section 5506 of the Factors for Operating Cost Rates of Payment 3. Impact Analysis of Table II Affordable Care Act. for Inpatient Hospital Services H. Effects of Other Policy Changes Under various statutory authorities, ES2 1. Effects of Policy Relating to New I. Background we are making changes to the Medicare RUL Medical Service and Technology Add- II. Inpatient Hospital Update for FY 2017 IPPS, to the LTCH PPS, and to other with On Payments A. FY 2017 Inpatient Hospital Update related payment methodologies and D 2. Effect of Changes Relating to Payment B. Update for SCHs and MDHs for FY 2017 PRO Adjustment for Medicare C. FY 2017 Puerto Rico Hospital Update programs for FY 2017 and subsequent G9T082 3. DEfifsepcrtosp oofr Rtieodnuatcet iSohna Uren Hdeors pthitea Hlso spital D. IUPPpSd ate for Hospitals Excluded From the fiinscclauld yee,a brus.t Tahree sneo st tlaimtuittoerdy taou, tthhoer ities SK3 Readmissions Reduction Program E. Update for LTCHs for FY 2017 following: D mstockstill on VerDate Sep<11>2014 20:18 Aug 19, 2016 Jkt 238001 PO 00000 Frm 00010 Fmt 4701 Sfmt 4700 E:\FR\FM\22AUR2.SGM 22AUR2 Federal Register/Vol. 81, No. 162/Monday, August 22, 2016/Rules and Regulations 56771 • Section 1886(d) of the Social form and manner, and at a time, establishment of site neutral payment Security Act (the Act), which sets forth specified by the Secretary. rate criteria under the LTCH PPS with a system of payment for the operating • Section 1886(o) of the Act, which implementation beginning in FY 2016. costs of acute care hospital inpatient requires the Secretary to establish a • Section 1886(m)(5)(D)(iv) of the stays under Medicare Part A (Hospital Hospital Value-Based Purchasing (VBP) Act, as added by section 1206 (c) of the Insurance) based on prospectively set Program under which value-based Pathway for Sustainable Growth Rate rates. Section 1886(g) of the Act requires incentive payments are made in a fiscal (SGR) Reform Act of 2013 (Pub. L. 113– that, instead of paying for capital-related year to hospitals meeting performance 67), which provides for the costs of inpatient hospital services on a standards established for a performance establishment of a functional status reasonable cost basis, the Secretary use period for such fiscal year. quality measure under the LTCH QRP a prospective payment system (PPS). • Section 1886(p) of the Act, as added for change in mobility among inpatients • Section 1886(d)(1)(B) of the Act, by section 3008 of the Affordable Care requiring ventilator support. which specifies that certain hospitals Act, which establishes a Hospital- • Section 1899B of the Act, as added and hospital units are excluded from the Acquired Condition (HAC) Reduction by the Improving Medicare Post-Acute IPPS. These hospitals and units are: Program, under which payments to Care Transformation Act of 2014 (the Rehabilitation hospitals and units; applicable hospitals are adjusted to IMPACT Act, Pub. L. 113–185), which LTCHs; psychiatric hospitals and units; provide an incentive to reduce hospital- imposes data reporting requirements for children’s hospitals; cancer hospitals; acquired conditions. certain post-acute care providers, and hospitals located outside the 50 • Section 1886(q) of the Act, as added including LTCHs. States, the District of Columbia, and by section 3025 of the Affordable Care • Section 1886(d)(12) of the Act, as Puerto Rico (that is, hospitals located in Act and amended by section 10309 of amended by section 204 of the Medicare the U.S. Virgin Islands, Guam, the the Affordable Care Act, which Access and CHIP Reauthorization Act of Northern Mariana Islands, and establishes the ‘‘Hospital Readmissions 2015, which extends, through FY 2017, American Samoa). Religious Reduction Program’’ effective for changes to the inpatient hospital nonmedical health care institutions discharges from an ‘‘applicable payment adjustment for certain low- (RNHCIs) are also excluded from the hospital’’ beginning on or after October volume hospitals; and section IPPS. 1, 2012, under which payments to those 1886(d)(5)(G) of the Act, as amended by • Sections 123(a) and (c) of the BBRA hospitals under section 1886(d) of the section 205 of the Medicare Access and (Pub. L. 106–113) and section 307(b)(1) Act will be reduced to account for CHIP Reauthorization Act of 2015, of the BIPA (Pub. L. 106–554) (as certain excess readmissions. codified under section 1886(m)(1) of the • Section 1886(r) of the Act, as added which extends, through FY 2017, the Medicare-dependent, small rural Act), which provide for the by section 3133 of the Affordable Care hospital (MDH) program. development and implementation of a Act, which provides for a reduction to • Section 1886(m)(6)(A)(i) and (E) of prospective payment system for disproportionate share hospital (DSH) the Act, as amended and added by payment for inpatient hospital services payments under section 1886(d)(5)(F) of section 231 of the Consolidated of long-term care hospitals (LTCHs) the Act and for a new uncompensated Appropriations Act, 2016 (Pub. L. 114– described in section 1886(d)(1)(B)(iv) of care payment to eligible hospitals. 113), which established a temporary the Act. Specifically, section 1886(r) of the Act exception to the site neutral payment • Sections 1814(l), 1820, and 1834(g) requires that, for fiscal year 2014 and rate under the LTCH PPS for certain of the Act, which specify that payments each subsequent fiscal year, subsection severe wound discharges from certain are made to critical access hospitals (d) hospitals that would otherwise LTCHs occurring prior to January 1, (CAHs) (that is, rural hospitals or receive a DSH payment made under 2017. facilities that meet certain statutory section 1886(d)(5)(F) of the Act will requirements) for inpatient and receive two separate payments: (1) 25 2. Summary of the Major Provisions outpatient services and that these percent of the amount they previously a. MS–DRG Documentation and Coding payments are generally based on 101 would have received under section Adjustment percent of reasonable cost. 1886(d)(5)(F) of the Act for DSH (‘‘the • Section 1866(k) of the Act, as added empirically justified amount’’), and (2) Section 631 of the American Taxpayer by section 3005 of the Affordable Care an additional payment for the DSH Relief Act (ATRA, Pub. L. 112–240) Act, which establishes a quality hospital’s proportion of uncompensated amended section 7(b)(1)(B) of Pub. L. reporting program for hospitals care, determined as the product of three 110–90 to require the Secretary to make described in section 1886(d)(1)(B)(v) of factors. These three factors are: (1) 75 a recoupment adjustment to the the Act, referred to as ‘‘PPS-exempt percent of the payments that would standardized amount of Medicare cancer hospitals.’’ otherwise be made under section payments to acute care hospitals to • Section 1886(a)(4) of the Act, which 1886(d)(5)(F) of the Act; (2) 1 minus the account for changes in MS–DRG specifies that costs of approved percent change in the percent of documentation and coding that do not educational activities are excluded from individuals under the age of 65 who are reflect real changes in case-mix, totaling the operating costs of inpatient hospital uninsured (minus 0.1 percentage points $11 billion over a 4-year period of FYs services. Hospitals with approved for FY 2014, and minus 0.2 percentage 2014, 2015, 2016, and 2017. This graduate medical education (GME) points for FY 2015 through FY 2017); adjustment represents the amount of the programs are paid for the direct costs of and (3) a hospital’s uncompensated care increase in aggregate payments as a S2 GME in accordance with section 1886(h) amount relative to the uncompensated result of not completing the prospective with RULE oAfc •tth, Sew eAhcitccitoh. n r e1q8u8i6r(ebs) (t3h)e(B S)e(vcirieit)a oryf tthoe ceaxr•per Seasemsceotdiuo nanst 1 oa8f p 8a6elrl( mcDe)Sn(6Hta) ghoeof. sthpeit aAlsc t, as a72d(0bj1u)3(s1.t )Pm(Areio)n rot fta oPu tuthhbeo. rALiz.T e1Rd1A 0u–,n 9tdh0ei sru nsaemticlot iFuoYnn t D RO reduce the applicable percentage added by section 1206(a)(1) of the could not have been recovered under P G9T082 ihnocsrpeiatsael fionr p aa fyimsceanl tyse taor aif stuhbes hecotsipointa (ld ) P(SaGthRw) aRye ffoorrm S uAsctat ionfa 2b0le1 3G (rPouwbt.h L R. a1t1e3 – PuWb.h Li.l e1 1o0u–r 9a0c.t uaries estimated that a K3 does not submit data on measures in a 67), which provided for the ¥9.3 percent adjustment to the S D mstockstill on VerDate Sep<11>2014 20:18 Aug 19, 2016 Jkt 238001 PO 00000 Frm 00011 Fmt 4701 Sfmt 4700 E:\FR\FM\22AUR2.SGM 22AUR2
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