24324 Federal Register/Vol. 80, No. 83/Thursday, April 30, 2015/Proposed Rules DEPARTMENT OF HEALTH AND participating in Medicare, including building. A stamp-in clock is available HUMAN SERVICES related proposals for eligible hospitals for persons wishing to retain a proof of and critical access hospitals filing by stamping in and retaining an Centers for Medicare & Medicaid participating in the Medicare Electronic extra copy of the comments being filed.) Services Health Record (EHR) Incentive Program. b. For delivery in Baltimore, MD— We also are proposing to update policies Centers for Medicare & Medicaid 42 CFR Part 412 relating to the Hospital Value-Based Services, Department of Health and Purchasing (VBP) Program, the Hospital Human Services, 7500 Security Office of the Secretary Readmissions Reduction Program, and Boulevard, Baltimore, MD 21244–1850. the Hospital-Acquired Condition (HAC) If you intend to deliver your 45 CFR Part 170 Reduction Program. comments to the Baltimore address, please call the telephone number (410) [CMS–1632–P] DATES: Comment Period: To be assured 786–7195 in advance to schedule your consideration, comments on all sections RIN–0938–AS41 of this proposed rule must be received arrival with one of our staff members. Comments mailed to the addresses at one of the addresses provided in the Medicare Program; Hospital Inpatient indicated as appropriate for hand or ADDRESSESsection no later than 5 p.m. Prospective Payment Systems for courier delivery may be delayed and EST on June 29, 2015. Acute Care Hospitals and the Long- received after the comment period. Term Care Hospital Prospective ADDRESSES: In commenting, please refer For information on viewing public Payment System Policy Changes and to file code CMS–1632–P. Because of comments, we refer readers to the Fiscal Year 2016 Rates; Revisions of staff and resource limitations, we cannot beginning of the SUPPLEMENTARY Quality Reporting Requirements for accept comments by facsimile (FAX) INFORMATIONsection. Specific Providers, Including Changes transmission. FORFURTHERINFORMATIONCONTACT: Related to the Electronic Health You may submit comments in one of Ing-Jye Cheng, (410) 786–4548 and Record Incentive Program four ways (no duplicates, please): Donald Thompson, (410) 786–4487, 1. Electronically. You may (and we Operating Prospective Payment, MS– AGENCY: Centers for Medicare and encourage you to) submit electronic DRGs, Deficit Reduction Act Hospital- Medicaid Services (CMS), HHS. comments on this regulation to http:// Acquired Acquired Conditions—Present ACTION: Proposed rule. www.regulations.gov. Follow the on Admission (DRA HAC–POA) instructions under the ‘‘submit a Program, Hospital-Acquired Conditions SUMMARY: We are proposing to revise the comment’’ tab. Reduction Program, Hospital Medicare hospital inpatient prospective 2. By regular mail. You may mail Readmission Reductions Program, Wage payment systems (IPPS) for operating written comments to the following Index, New Medical Service and and capital-related costs of acute care address ONLY: Centers for Medicare & Technology Add-On Payments, Hospital hospitals to implement changes arising Medicaid Services, Department of Geographic Reclassifications, Graduate from our continuing experience with Health and Human Services, Attention: Medical Education, Capital Prospective these systems for FY 2016. Some of CMS–1632–P, P.O. Box 8013, Baltimore, Payment, Excluded Hospitals, and these changes implement certain MD 21244–1850. Medicare Disproportionate Share statutory provisions contained in the Please allow sufficient time for mailed Hospital (DSH) Issues. Patient Protection and Affordable Care comments to be received before the Michele Hudson, (410) 786–4487, Act and the Health Care and Education close of the comment period. Long-Term Care Hospital Prospective Reconciliation Act of 2010 (collectively 3. By express or overnight mail. You Payment System and MS–LTC–DRG known as the Affordable Care Act), the may send written comments via express Relative Weights Issues. Pathway for Sustainable Growth Reform or overnight mail to the following Siddhartha Mazumdar, (410) 786– (SGR) Act of 2013, the Protecting Access address ONLY: Centers for Medicare & 6673, Rural Community Hospital to Medicare Act of 2014, and other Medicaid Services, Department of Demonstration Program Issues. legislation. We also are addressing the Health and Human Services, Attention: Cindy Tourison, (410) 786–1093, update of the rate-of-increase limits for CMS–1632–P, Mail Stop C4–26–05, Hospital Inpatient Quality Reporting certain hospitals excluded from the 7500 Security Boulevard, Baltimore, MD and Hospital Value-Based Purchasing— IPPS that are paid on a reasonable cost 21244–1850. Program Administration, Validation, basis subject to these limits for FY 2016. 4. By hand or courier. If you prefer, and Reconsideration Issues. We also are proposing to update the you may deliver (by hand or courier) Pierre Yong, (410) 786–8896, Hospital payment policies and the annual your written comments before the close Inpatient Quality Reporting—Measures payment rates for the Medicare of the comment period to either of the Issues Except Hospital Consumer prospective payment system (PPS) for following addresses: Assessment of Healthcare Providers and inpatient hospital services provided by a. For delivery in Washington, DC— Systems Issues. long-term care hospitals (LTCHs) for FY Centers for Medicare & Medicaid Elizabeth Goldstein, (410) 786–6665, 2016 and implement certain statutory Services, Department of Health and Hospital Inpatient Quality Reporting— changes to the LTCH PPS under the Human Services, Room 445–G, Hubert Hospital Consumer Assessment of Affordable Care Act and the Pathway for H. Humphrey Building, 200 Healthcare Providers and Systems Sustainable Growth Rate (SGR) Reform Independence Avenue SW., Measures Issues. ALS2 Act of 2013 and the Protecting Access Washington, DC 20201. Mary Pratt, (410) 786–6867, LTCH OS to Medicare Act of 2014. (Because access to the interior of the Quality Data Reporting Issues. P O In addition, we are proposing to Hubert H. Humphrey Building is not Kim Spalding Bush, (410) 786–3232, R D with P eesxtiasbtilnisgh r enqeuwi rreemquenirtesm foern qtsu oarli ttoy revise rFeeaddeirlayl aGvoavilearbnlme teon pt eidrseonntisf iwcaitthioonu,t HEfofiscpiietnacl yV aMlueea-sBuaresse dIs Psuuercs.h asing O R reporting by specific providers (acute commenters are encouraged to leave James Poyer, (410) 786–2261, PPS- P N1 care hospitals, PPS-exempt cancer their comments in the CMS drop slots Exempt Cancer Hospital Quality V T SP hospitals, and LTCHs) that are located in the main lobby of the Reporting Issues. K3 S D tkelley on VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 Federal Register/Vol. 80, No. 83/Thursday, April 30, 2015/Proposed Rules 24325 Deborah Krauss, (410) 786–5264, and we refer readers to section VI. of the CERT Comprehensive error rate testing Alexandra Mugge, (410–786–4457), EHR Addendum to this proposed rule. CDI Clostridium difficile (C. difficile) Incentive Program Clinical Quality Readers who experience any problems CFR Code of Federal Regulations Measure Related Issues. accessing any of the tables that are CLABSI Central line-associated bloodstream infection Elizabeth Myers, (410) 786–4751, EHR posted on the CMS Web sites identified CIPI Capital input price index Incentive Program Nonclinical Quality above should contact Michael Treitel at CMI Case-mix index Measure Related Issues. (410) 786–4552. CMS Centers for Medicare & Medicaid Lauren Wu, (202) 690–7151, Certified Services Acronyms EHR Technology Related Issues. CMSA Consolidated Metropolitan Kellie Shannon, (410) 786–0416, 3M 3M Health Information System Statistical Area Simplified Cost Allocation Methodology AAMC Association of American Medical COBRA Consolidated Omnibus Issues. Colleges Reconciliation Act of 1985, Public Law 99– SUPPLEMENTARYINFORMATION: Inspection ACGME Accreditation Council for Graduate 272 Medical Education COLA Cost-of-living adjustment of Public Comments: All public ACoS American College of Surgeons COPD Chronis obstructive pulmonary comments received before the close of AHA American Hospital Association disease the comment period are available for AHIC American Health Information CPI Consumer price index viewing by the public, including any Community CQM Clinical quality measure personally identifiable or confidential AHIMA American Health Information CY Calendar year business information that is included in Management Association DACA Data Accuracy and Completeness a comment. We post all public AHRQ Agency for Healthcare Research and Acknowledgement comments received before the close of Quality DPP Disproportionate patient percentage the comment period on the following AJCC American Joint Committee on Cancer DRA Deficit Reduction Act of 2005, Public ALOS Average length of stay Law 109–171 Web site as soon as possible after they ALTHA Acute Long Term Hospital DRG Diagnosis-related group have been received: http:// Association DSH Disproportionate share hospital www.regulations.gov. Follow the search AMA American Medical Association EBRT External Bean Radiotherapy instructions on that Web site to view AMGA American Medical Group ECI Employment cost index public comments. Association eCQM Electronic clinical quality measure AMI Acute myocardial infarction EDB [Medicare] Enrollment Database Electronic Access AOA American Osteopathic Association EHR Electronic health record This Federal Register document is APR DRG All Patient Refined Diagnosis EMR Electronic medical record also available from the Federal Register Related Group System EMTALA Emergency Medical Treatment online database through Federal Digital APRN Advanced practice registered nurse and Labor Act of 1986, Public Law 99–272 System (FDsys), a service of the U.S. ARRA American Recovery and EP Eligible professional Government Publishing Office. This Reinvestment Act of 2009, Public Law FAH Federation of American Hospitals 111–5 FDA Food and Drug Administration database can be accessed via the ASCA Administrative Simplification FFY Federal fiscal year Internet at: http://www.gpo.gov/fdsys. Compliance Act of 2002, Public Law 107– FPL Federal poverty line Tables Available Only Through the 105 FQHC Federally qualified health center Internet on the CMS Web site ASITN American Society of Interventional FR Federal Register and Therapeutic Neuroradiology FTE Full-time equivalent In the past, a majority of the tables ASPE Assistant Secretary for Planning and FY Fiscal year referred to throughout this preamble Evaluation [DHHS] GAF Geographic Adjustment Factor and in the Addendum to the proposed ATRA American Taxpayer Relief Act of GME Graduate medical education rule and the final rule were published 2012, Public Law 112–240 HAC Hospital-acquired condition in the Federal Register as part of the BBA Balanced Budget Act of 1997, Public HAI Healthcare-associated infection annual proposed and final rules. Law 105–33 HCAHPS Hospital Consumer Assessment of BBRA Medicare, Medicaid, and SCHIP Healthcare Providers and Systems However, beginning in FY 2012, some of [State Children’s Health Insurance HCFA Health Care Financing the IPPS tables and LTCH PPS tables are Program] Balanced Budget Refinement Act Administration no longer published in the Federal of 1999, Public Law 106–113 HCO High-cost outlier Register. Instead, these tables are BIPA Medicare, Medicaid, and SCHIP [State HCP Healthcare personnel generally only available through the Children’s Health Insurance Program] HCRIS Hospital Cost Report Information Internet. The IPPS tables for this Benefits Improvement and Protection Act System proposed rule are available through the of 2000, Public Law 106–554 HHA Home health agency Internet on the CMS Web site at: http:// BLS Bureau of Labor Statistics HHS Department of Health and Human www.cms.hhs.gov/Medicare/medicare- CABG Coronary artery bypass graft Services [surgery] HICAN Health Insurance Claims Account Fee-for-Service-Payment/ CAH Critical access hospital Number AcuteInpatientPPS/index.html. Click on CARE [Medicare] Continuity Assessment HIPAA Health Insurance Portability and the link on the left side of the screen Record & Evaluation [Instrument] Accountability Act of 1996, Public Law titled, ‘‘FY 2016 IPPS Proposed Rule CART CMS Abstraction & Reporting Tool 104–191 Home Page’’ or ‘‘Acute Inpatient—Files CAUTI Catheter-associated urinary tract HIPC Health Information Policy Council for Download’’. The LTCH PPS tables infection HIS Health information system for this FY 2016 proposed rule are CBSAs Core-based statistical areas HIT Health information technology S2 available through the Internet on the CC Complication or comorbidity HMO Health maintenance organization OSAL CMS Web site at: http://www.cms.gov/ CCN CMS Certification Number HPMP Hospital Payment Monitoring P CCR Cost-to-charge ratio Program O Medicare/Medicare-Fee-for-Service- OD with PR Pinadyemxe.hnttm/Llo unngdTeerr mthCe alrisetH iotesmpi tfaolrP PS/ CCDDCAAeCnDter[C Mloesdtricidairue]m C dliinffiiccaille D-aastsao Acibastterda ction HHSSRACeRvCieHwe [aCMltohamr symalvainisnsdig]os Hn a ecaclotuhn Ste rvices Cost PR Regulation Number CMS–1632–P. For disease HSRV Hospital-specific relative value VN1 further details on the contents of the CDC Center for Disease Control and HSRVcc Hospital-specific relative value T SP tables referenced in this proposed rule, Prevention cost center K3 S D tkelley on VerDate Sep<11>2014 22:00 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 24326 Federal Register/Vol. 80, No. 83/Thursday, April 30, 2015/Proposed Rules HQA Hospital Quality Alliance NALTH National Association of Long Term RUCAs Rural-urban commuting area codes HQI Hospital Quality Initiative Hospitals RY Rate year HwH Hospital-within-hospital NCD National coverage determination SAF Standard Analytic File IBR Intern- and Resident-to-Bed Ratio NCHS National Center for Health Statistics SCH Sole community hospital ICD–9–CM International Classification of NCQA National Committee for Quality SCHIP State Child Health Insurance Diseases, Ninth Revision, Clinical Assurance Program Modification NCVHS National Committee on Vital and SCIP Surgical Care Improvement Project ICD–10–CM International Classification of Health Statistics SFY State fiscal year Diseases, Tenth Revision, Clinical NECMA New England County Metropolitan SGR Sustainable Growth Rate Modification Areas SIC Standard Industrial Classification ICD–10–PCS International Classification of NHSN National Healthcare Safety Network SNF Skilled nursing facility Diseases, Tenth Revision, Procedure NQF National Quality Forum SOCs Standard occupational classifications Coding System NQS National Quality Strategy SOM State Operations Manual ICR Information collection requirement NTIS National Technical Information SSI Surgical site infection ICU Intensive care unit Service SSI Supplemental Security Income IGI IHS Global Insight, Inc. NTTAA National Technology Transfer and SSO Short-stay outlier IHS Indian Health Service Advancement Act of 1991, Public Law SUD Substance use disorder IME Indirect medical education 104–113 TEFRA Tax Equity and Fiscal I–O Input-Output NUBC National Uniform Billing Code Responsibility Act of 1982, Public Law 97– IOM Institute of Medicine NVHRI National Voluntary Hospital 248 IPF Inpatient psychiatric facility Reporting Initiative TEP Technical expert panel IPFQR Inpatient Psychiatric Facility OACT [CMS] Office of the Actuary THA/TKA Total hip arthroplasty/Total Quality Reporting [Program] OBRA 86 Omnibus Budget Reconciliation knee arthroplasty IPPS [Acute care hospital] inpatient Act of 1986, Public Law 99–509 TMA TMA [Transitional Medical prospective payment system OES Occupational employment statistics Assistance], Abstinence Education, and QI IRF Inpatient rehabilitation facility OIG Office of the Inspector General [Qualifying Individuals] Programs Extension Act of 2007, Public Law 110–90 IQR Inpatient Quality Reporting OMB [Executive] Office of Management and TPS Total Performance Score LAMCs Large area metropolitan counties Budget UHDDS Uniform hospital discharge data set LOS Length of stay ONC Office of the National Coordinator for UMRA Unfunded Mandate Reform Act, LTC–DRG Long-term care diagnosis-related Health Information Technology Public Law 104–4 group OPM [U.S.] Office of Personnel VBP [Hospital] Value Based Purchasing LTCH Long-term care hospital Management [Program] LTCH QRP Long-Term Care Hospital OQR [Hospital] Outpatient Quality VTE Venous thromboembolism Quality Reporting Program Reporting MAC Medicare Administrative Contractor O.R. Operating room Table of Contents MAP Measure Application Partnership OSCAR Online Survey Certification and MCC Major complication or comorbidity Reporting [System] I. Executive Summary and Background A. Executive Summary MCE Medicare Code Editor PAC Postacute care 1. Purpose and Legal Authority MCO Managed care organization PAMA Protecting Access to Medicare Act of 2. Summary of the Major Provisions MDC Major diagnostic category 2014, Public Law 113–93 3. Summary of Costs and Benefits MDH Medicare-dependent, small rural PCH PPS-exempt cancer hospital B. Summary hospital PCHQR PPS-exempt cancer hospital quality 1. Acute Care Hospital Inpatient MedPAC Medicare Payment Advisory reporting Prospective Payment System (IPPS) Commission PMSAs Primary metropolitan statistical 2. Hospitals and Hospital Units Excluded MedPAR Medicare Provider Analysis and areas From the IPPS Review File POA Present on admission 3. Long-Term Care Hospital Prospective MEI Medicare Economic Index PPI Producer price index Payment System (LTCH PPS) MGCRB Medicare Geographic Classification PPS Prospective payment system 4. Critical Access Hospitals (CAHs) Review Board PRM Provider Reimbursement Manual 5. Payments for Graduate Medical MIEA–TRHCA Medicare Improvements and ProPAC Prospective Payment Assessment Education (GME) Extension Act, Division B of the Tax Relief Commission C. Summary of Provisions of Recent and Health Care Act of 2006, Public Law PRRB Provider Reimbursement Review Legislation Discussed in This Proposed 109–432 Board Rule MIPPA Medicare Improvements for Patients PRTFs Psychiatric residential treatment 1. Patient Protection and Affordable Care and Providers Act of 2008, Public Law facilities Act (Pub. L. 111–148) and the Health 110–275 PSF Provider-Specific File Care and Education Reconciliation Act of MMA Medicare Prescription Drug, PSI Patient safety indicator 2010 (Pub. L. 111–152) Improvement, and Modernization Act of PS&R Provider Statistical and 2. American Taxpayer Relief Act of 2012 2003, Public Law 108–173 Reimbursement [System] (Pub. L. 112–240) MMEA Medicare and Medicaid Extenders PQRS Physician Quality Reporting System 3. Pathway for Sustainable Growth Rate Act of 2010, Public Law 111–309 QIG Quality Improvement Group [CMS] (SGR) Reform Act of 2013 (Pub. L. 113– MMSEA Medicare, Medicaid, and SCHIP QRDA Quality Reporting Data Architecture 67) Extension Act of 2007, Public Law 110–173 RFA Regulatory Flexibility Act, Public Law 4. Protecting Access to Medicare Act of MRHFP Medicare Rural Hospital Flexibility 96–354 2014 (Pub. L. 113–93) Program RHC Rural health clinic D. Summary of the Major Provisions of this MRSA Methicillin-resistant Staphylococcus RHQDAPU Reporting hospital quality data Proposed Rule aureus for annual payment update II. Proposed Changes to Medicare Severity S2 MSA Metropolitan Statistical Area RNHCI Religious nonmedical health care Diagnosis-Related Group (MS–DRG) SAL MS–DRG Medicare severity diagnosis- institution Classifications and Relative Weights O OP related group RPL Rehabilitation psychiatric long-term A. Background PR MS–LTC–DRG Medicare severity long-term care (hospital) B. MS–DRG Reclassifications with care diagnosis-related group RRC Rural referral center C. Adoption of the MS–DRGs in FY 2008 OD MU Meaningful Use [EHR Incentive RSMR Risk-standardized mortality rate D. Proposed FY 2016 MS–DRG PR Program] RSRR Risk-standard readmission rate Documentation and Coding Adjustment VN1 NAICS North American Industrial RTI Research Triangle Institute, 1. Background on the Prospective MS–DRG T SP Classification System International Documentation and Coding Adjustments K3 S D tkelley on VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 Federal Register/Vol. 80, No. 83/Thursday, April 30, 2015/Proposed Rules 24327 for FY 2008 and FY 2009 Authorized by 5. MDC 14 (Pregnancy, Childbirth and the d. Argus® II Retinal Prosthesis System Public Law 110–90 Puerperium): MS–DRG 775 (Vaginal e. Zilver® PTX® Drug-Eluting Peripheral 2. Adjustment to the Average Standardized Delivery With Complicating Diagnosis) Stent Amounts Required by Public Law 110– 6. MDC 21 (Injuries, Poisoning and Toxic f. CardioMEMSTMHF (Heart Failure) 90 Effects of Drugs): CroFab Antivenin Drug Monitoring System a. Prospective Adjustment Required by 7. MDC 22 (Burns): Additional Severity of g. MitraClip® System Section 7(b)(1)(A) of Public Law 110–90 Illness Level for MS–DRG 927 (Extensive h. Responsive Neurostimulator (RNS® b. Recoupment or Repayment Adjustments Burns or Full Thickness Burns With System) in FYs 2010 Through 2012 Required by Mechanical Ventilation 96 + Hours With 5. FY 2016 Applications for New Section 7(b)(1)(B) Public Law 110–90 Skin Graft) Technology Add-On Payments 3. Retrospective Evaluation of FY 2008 and 8. Proposed Medicare Code Editor (MCE) a. Angel Medical Guardian® Ischemia FY 2009 Claims Data Changes Monitoring Device 4. Prospective Adjustments for FY 2008 9. Proposed Changes to Surgical b. Blinatumomab (BLINCYTOTM) and FY 2009 Authorized by Section Hierarchies c. Ceftazidime Avibactam (AVYCAZ) 7(b)(1)(A) of Public Law 110–90 10. Proposed Changes to the MS–DRG d. DIAMONDBACK® 360 Coronary Orbital 5. Recoupment or Repayment Adjustment Diagnosis Codes for FY 2016 Atherectomy System Authorized by Section 7(b)(1)(B) of a. Major Complications or Comorbidities e. CRESEMBA® (Isavuconazonium) Public Law 110–90 (MCCs) and Complications or f. Idarucizumab 6. Proposed Recoupment or Repayment Comorbidities (CCs) Severity Levels for g. LUTONIX® Drug Coated Balloon (DCB) Adjustment Authorized by Section 631 FY 2016 Percutaneous Transluminal Angioplasty of the American Taxpayer Relief Act of b. Coronary Atherosclerosis Due to (PTA) and IN.PACTTMAdmiralTM 2012 (ATRA) Calcified Coronary Lesion Pacliaxel Coated Percutaneous E. Refinement of the MS–DRG Relative c. Hydronephrosis Transluminal Angioplasty (PTA) Balloon Weight Calculation 11. Proposed Complications or Catheter 1. Background Comorbidity (CC) Exclusions List for FY h. VERASENSETMKnee Balancer System 2. Discussion for FY 2016 and Request for 2016 (VKS) Comments on Nonstandard Cost Center a. Background i. WATCHMAN® Left Atrial Appendage Codes b. Proposed CC Exclusions List for FY 2016 Closure Technology F. Proposed Adjustment to MS–DRGs for 12. Review of Procedure Codes in MS– III. Proposed Changes to the Hospital Wage Preventable Hospital-Acquired DRGs 981 Through 983, 984 Through Index for Acute Care Hospitals Conditions (HACs), Including Infections, 986, and 987 Through 989 A. Background for FY 2016 a. Moving Procedure Codes From MS– 1. Legislative Authority 1. Background DRGs 981 Through 983 or MS–DRGs 987 2. Core-Based Statistical Areas (CBSAs) for 2. HAC Selection Through 989 Into MDCs the Hospital Wage Index 3. Present on Admission (POA) Indicator b. Reassignment of Procedures Among MS– B. Worksheet S–3 Wage Data for the Reporting DRGs 981 Through 983, 984 through 986, Proposed FY 2016 Wage Index 4. HACs and POA Reporting in Preparation and 987 Through 989 1. Included Categories of Costs for Transition to ICD–10–CM and ICD– c. Adding Diagnosis or Procedure Codes to 2. Excluded Categories of Costs 10–PCS MDCs 3. Use of Wage Index Data by Suppliers 5. Proposed Changes to the HAC Program 13. Proposed Changes to the ICD–9–CM and Providers Other Than Acute Care for FY 2016 Coding System in FY 2016 Hospitals Under the IPPS 6. RTI Program Evaluation a. ICD–10 Coordination and Maintenance C. Verification of Worksheet S–3 Wage 7. RTI Report on Evidence-Based Committee Data Guidelines b. Code Freeze D. Method for Computing the Proposed FY G. Proposed Changes to Specific MS–DRG 14. Other Proposed Policy Change: 2016 Unadjusted Wage Index Classifications Recalled/Replaced Devices E. Proposed Occupational Mix Adjustment 1. Discussion of Changes to Coding System H. Recalibration of the Proposed FY 2016 to the Proposed FY 2016 Wage Index and Basis for MS–DRG Updates MS–DRG Relative Weights 1. Development of Data for the Proposed a. Conversion of MS–DRGs to the 1. Data Sources for Developing the FY 2016 Occupational Mix Adjustment International Classification of Diseases, Proposed Relative Weights Based on the 2013 Medicare Wage Index 10th Edition (ICD–10) 2. Methodology for Calculation of the Occupational Mix Survey b. Basis for Proposed FY 2016 MS–DRG Proposed Relative Weights 2. New 2013 Occupational Mix Survey Updates 3. Development of Proposed National Data for the Proposed FY 2016 Wage 2. MDC 1 (Diseases and Disorders of the Average CCRs Index Nervous System): Endovascular 4. Solicitation of Public Comments on 3. Calculation of the Proposed Embolization (Coiling) Procedures Expanding the Bundled Payments for Occupational Mix Adjustment for FY 3. MDC 5 (Diseases and Disorders of the Care Improvement (BPCI) Initiative 2016 Circulatory System) a. Background F. Analysis and Implementation of the a. Adding Severity Levels to MS–DRGs 245 b. Considerations for Potential Model Proposed Occupational Mix Adjustment Through 251 Expansion and the Proposed FY 2016 Occupational b. Percutaneous Intracardiac Procedures I. Proposed Add-On Payments for New Mix Adjusted Wage Index c. Zilver® PTX Drug-Eluting Peripheral Services and Technologies G. Transitional Wage Indexes Stent (ZPTX® ) 1. Background 1. Background d. Percutaneous Mitral Valve Repair 2. Public Input Before Publication of a 2. Transition for Hospitals in Urban Areas System—Proposed Revision of ICD–10– Notice of Proposed Rulemaking on Add- That Became Rural PCS Version 32 Logic On Payments 3. Transition for Hospitals Deemed Urban e. Major Cardiovascular Procedures: 3. Implementation of ICD–10–PCS Section Under Section 1886(d)(8)(B) of the Act S2 Zenith® Fenestrated Abdominal Aortic ‘‘X’’ Codes for Certain New Medical Where the Urban Area Became Rural SAL Aneurysm (AAA) Endovascular Graft Services and Technologies for FY 2016 Under the New OMB Delineations O P 4. MDC 8 (Diseases and Disorders of the 4. Proposed FY 2016 Status of 4. Expiring Transition for Hospitals That O PR Musculoskeletal System and Connective Technologies Approved for FY 2015 Experience a Decrease in Wage Index with Tissue) Add-On Payments under the New OMB Delineations OD a. Revision of Hip or Knee Replacement: a. Glucarpidase (Voraxaze® ) 5. Budget Neutrality PR Proposed Revision of ICD–10 Version 32 b. Zenith® Fenestrated Abdominal Aortic H. Proposed Application of the Rural, VN1 Logic Aneurysm (AAA) Endovascular Graft Imputed, and Frontier Floors T SP b. Spinal Fusion c. KcentraTM 1. Proposed Rural Floor K3 S D tkelley on VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 24328 Federal Register/Vol. 80, No. 83/Thursday, April 30, 2015/Proposed Rules 2. Proposed Imputed Floor for FY 2016 E. Hospital Readmissions Reduction a. Intent To Propose in Future Rulemaking 3. Proposed State Frontier Floor Program: Proposed Changes for FY 2016 To Include Selected Ward (Non- I. Proposed FY 2016 Wage Index Tables Through FY 2017 (§§412.150 Through Intensive Care Unit (ICU)) Locations in J. Revisions to the Wage Index Based on 412.154) Certain NHSN Measures Beginning With Hospital Redesignations and 1. Statutory Basis for the Hospital the FY 2019 Program Year Reclassifications Readmissions Reduction Program b. Proposed New Measure for the FY 2021 1. General Policies and Effects of 2. Regulatory Background Program Year: Hospital 30-Day, All- Reclassification and Redesignation 3. Overview of Proposed Policies Changes Cause, Risk-Standardized Mortality Rate 2. FY 2016 MGCRB Reclassifications and for the FY 2016 and FY 2017 Hospital Following Chronic Obstructive Redesignation Issues Readmissions Reduction Program Pulmonary Disease (COPD) a. FY 2016 Reclassification Requests and 4. Proposed Refinement of Hospital 30- Hospitalization (NQF #1893) Approvals Day, All Cause, Risk-Standardized c. Summary of Previously Adopted and b. Applications for Reclassifications for FY Readmission Rate (RSSR) Following Newly Proposed Measures for the FY 2017 Pneumonia Hospitalization Measure 2019 and FY 2021 and Subsequent 3. Redesignations of Hospitals Under Cohort (NQF #0506) for FY 2017 Program Years Section 1886(d)(8)(B) of the Act (Lugar) Payment Determination and Subsequent 4. Possible Measure Topics for Future 4. Waiving Lugar Redesignation for the Years Program Years Out-Migration Adjustment a. Background 5. Previously Adopted and Newly K. Proposed Out-Migration Adjustment b. Overview of Measure Cohort Change Proposed Baseline and Performance Based on Commuting Patterns of c. Risk Adjustment Periods for the FY 2018 Program Year Hospital Employees d. Anticipated Effect of Refinement of a. Background 1. Background Hospital 30-Day, All-Cause, Risk- b. Proposed Baseline and Performance 2. New Data Source for the Proposed FY Standardized Readmission Rate (RSSR) Periods for the Patient and Caregiver- 2016 Out-Migration Adjustment Following Pneumonia Hospitalization Centered Experience of Care/Care 3. Proposed FY 2016 Out-Migration Measure (NQF #0506) Cohort Coordination Domain for the FY 2018 Adjustment e. Calculating the Excess Readmissions Program Year 4. Use of Out-Migration Data Applied for Ratio c. Proposed Baseline and Performance FY 2014 or FY 2015 for 3 Years 5. Maintenance of Technical Specifications Periods for NHSN Measures and PC–01 L. Process for Requests for Wage Index for Quality Measures in the Safety Domain for the FY 2018 Data Corrections 6. Floor Adjustment Factor for FY 2016 Program Year M. Labor-Related Share for the Proposed (§412.154(c)(2)) d. Proposed Baseline and Performance FY 2016 Wage Index 7. Proposed Applicable Period for FY 2016 Periods for the Efficiency and Cost N. Proposed Changes to 3-Year Average for 8. Proposed Calculation of Aggregate Reduction Domain for the FY 2018 the FY 2017 Wage Index Pension Costs Payments for Excess Readmissions for Program Year and Proposed Change to Wage Index FY 2016 e. Summary of Previously Finalized and Timeline Regarding Pension Costs for FY a. Background Newly Proposed Baseline and 2017 and Subsequent Years b. Proposed Calculation of Aggregate Performance Periods for the FY 2018 O. Clarification of Allocation of Pension Payments for Excess Readmissions for Program Year Costs for the Wage Index FY 2016 6. Previously Adopted and Newly IV. Other Decisions and Proposed Changes to 9. Proposed Extraordinary Circumstances Proposed Baseline and Performance the IPPS for Operating Costs and Indirect Exception Policy for the Hospital Periods for Future Program Years Medical Education (IME) Costs Readmissions Reduction Program a. Previously Adopted Baseline and A. Proposed Changes in the Inpatient Beginning FY 2016 and for Subsequent Performance Periods for the FY 2019 Hospital Updates for FY 2016 Years Program (§§412.64(d) and 412.211(c)) a. Background b. Proposed Baseline and Performance 1. Proposed FY 2016 Inpatient Hospital b. Requests for an Extraordinary Periods for the PSI–90 Measure in the Update Circumstances Exception Safety Domain in the FY 2020 Program 2. Proposed FY 2016 Puerto Rico Hospital F. Hospital Value-Based Purchasing (VBP) Years Update Program: Proposed Policy Changes for c. Proposed Baseline and Performance B. Rural Referral Centers (RRCs): Proposed the FY 2018 Program Year and Periods for the Clinical Care Domain for Annual Updates to Case-Mix Index (CMI) Subsequent Years the FY 2021 Program Year and Discharge Criteria (§412.96) 1. Background 7. Proposed Performance Standards for the 1. Case-Mix Index (CMI) a. Statutory Background and Overview of Hospital VBP Program 2. Discharges Past Program Years a. Background C. Indirect Medical Education (IME) b. FY 2016 Program Year Payment Details b. Technical Updates Payment Adjustment for FY 2016 2. Proposed Retention, Removal, c. Proposed Performance Standards for the (§412.105) Expansion, and Updating of Quality FY 2018 Program Year D. Proposed FY 2016 Payment Adjustment Measures for FY 2018 Program Year d. Previously Adopted Performance for Medicare Disproportionate Share a. Retention of Previously Adopted Standards for Certain Measures for the Hospitals (DSHs) (§412.106) Hospital VBP Program Measures for the FY 2019 Program Year 1. Background FY 2018 Program Year e. Previously Adopted and Newly 2. Impact on Medicare DSH Payment b. Proposed Removal of Two Measures Proposed Performance Standards for Adjustment of the Continued c. Proposed New Measure for the FY 2018 Certain Measures for the FY 2020 Implementation of New OMB Labor Program Year: 3-Item Care Transition Program Year Market Area Delineations Measure (CTM–3) (NQF #0228) f. Proposed Performance Standards for 3. Payment Adjustment Methodology for d. Proposed Removal of Clinical Care— Certain Measures for the FY 2021 Medicare Disproportionate Share Process Subdomain for the FY 2018 Program Year S2 Hospitals (DSHs) Under Section 3133 of Program Year and Subsequent Years 8. Proposed FY 2018 Program Year Scoring SAL the Affordable Care Act e. NHSN Measures Standard Population Methodology O P a. General Discussion Data a. Proposed Domain Weighting for the FY O PR b. Eligibility for Empirically Justified f. Summary of Previously Adopted and 2018 Program Year for Hospitals That with Medicare DSH Payments and Newly Proposed Measures for the FY Receive a Score on All Domains OD Uncompensated Care Payments 2018 Program Year b. Proposed Domain Weighting for the FY PR c. Empirically Justified Medicare DSH 3. Previously Adopted and Newly 2018 Program Year for Hospitals VN1 Payments Proposed Measures for the FY 2019, FY Receiving Scores on Fewer Than Four T SP d. Uncompensated Care Payments 2021, and Subsequent Program Years Domains K3 S D tkelley on VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 Federal Register/Vol. 80, No. 83/Thursday, April 30, 2015/Proposed Rules 24329 G. Proposed Changes to the Hospital- B. Proposed Application of Site Neutral b. Proposed Revision of Certain Market Acquired Condition (HAC) Reduction Payment Rate (Proposed New §412.522) Basket Updates as Required by the Program 1. Overview Affordable Care Act 1. Background 2. Proposed Application of the Site Neutral c. Proposed Adjustment to the Annual 2. Statutory Basis for the HAC Reduction Payment Rate Under the LTCH PPS Update to the LTCH PPS Standard Program 3. Criteria for Exclusion From the Site Federal Rate Under the Long-Term Care 3. Overview of Previous HAC Reduction Neutral Payment Rate Hospital Quality Reporting Program Program Rulemaking a. Statutory Provisions (LTCH QRP) 4. Implementation of the HAC Reduction b. Proposed Implementation of Criterion d. Proposed Market Basket Under the Program for FY 2016 for a Principal Diagnosis Relating to a LTCH PPS for FY 2016 5. Proposed Changes for Implementation of Psychiatric Diagnosis or to Rehabilitation e. Proposed Annual Market Basket Update the HAC Reduction Program for FY 2017 c. Proposed Addition of Definition of for LTCHs for FY 2016 a. Proposed Applicable Time Period for the ‘‘Subsection (d) Hospital’’ to LTCH E. Moratoria on the Establishment of FY 2017 HAC Reduction Program Regulations LTCHs and LTCH Satellite Facilities and b. Proposed Narrative Rule Used in d. Proposed Interpretation of ‘‘Immediately on the Increase in Number of Beds in Calculation of the Domain 2 Score for the Preceded’’ by a Subsection (d) Hospital Existing LTCHs and LTCH Satellite FY 2017 HAC Reduction Program Discharge Facilities c. Proposed Domain 1 and Domain 2 e. Proposed Implementation of Intensive F. Proposed Changes to Average Length of Weights for the FY 2017 HAC Reduction Care Unit (ICU) Criterion Stay Criterion Under Public Law 113–67 Program f. Proposed Implementation of the (§412.23) 6. Proposed Measure Refinements for the Ventilator Criterion VIII. Proposed Quality Data Reporting FY 2018 HAC Reduction Program 4. Proposed Determination of the Site Requirements for Specific Providers and a. Proposal To Include Select Ward (Non- Neutral Payment Rate (Proposed New Suppliers for FY 2016 Intensive Care Unit (ICU)) Locations in §412.522(c)) A. Hospital Inpatient Quality Reporting Certain CDC NHSN Measures Beginning a. General (IQR) Program in the FY 2018 Program Year b. Proposed Blended Payment Rate for FY 1. Background b. Update to CDC NHSN Measures 2016 and FY 2017 a. History of the Hospital IQR Program Standard Population Data c. Proposed LTCH PPS Standard Federal b. Maintenance of Technical Specifications 7. Maintenance of Technical Specifications Payment Rate for Quality Measures for Quality Measures 5. Proposed Application of Certain Exiting c. Public Display of Quality Measures 8. Proposed Extraordinary Circumstances LTCH PPS Payment Adjustments to 2. Process for Retaining Previously Exception Policy for the HAC Reduction Payments Made Under the Site Neutral Adopted Hospital IQR Program Measures Program Beginning in FY 2016 and for Payment Rate for Subsequent Payment Determinations Subsequent Years 6. Proposals Relating to the LTCH 3. Removal and Suspension of Hospital a. Background Discharge Payment Percentage IQR Program Measures b. Requests for an Extraordinary 7. Additional LTCH PPS Policy a. Considerations in Removing Quality Circumstances Exception Considerations Related to the Measures From the Hospital IQR H. Proposed Elimination of Simplified Cost Implementation of the Site Neutral Program Allocation Methodology Payment Rate Required by Section b. Proposed Removal of Hospital IQR 1. Background 1206(a) of Public Law 113–67 Program Measures for the FY 2018 2. Proposed Changes a. MS–LTC–DRG Relative Payment Payment Determination and Subsequent I. Rural Community Hospital Weights Years Demonstration Program b. High-Cost Outliers 4. Previously Adopted Hospital IQR 1. Background c. Limitation on Charges to Beneficiaries Program Measures for the FY 2017 2. Proposed FY 2016 Budget Neutrality C. Proposed Medicare Severity Long-Term Payment Determination and Subsequent Offset Amount Care Diagnosis-Related Group (MS–LTC– Years J. Proposed Changes to MS–DRGs Subject DRG) Classifications and Relative a. Background to the Postacute Care Transfer Policy Weights for FY 2016 b. NHSN Measures Standard Population (§412.4) 1. Background Data 1. Background 2. Patient Classifications into MS–LTC– 5. Expansion and Updating of Quality 2. Proposed Changes to the Postacute Care DRGs Measures Transfer MS–DRGs a. Background 6. Proposed Refinements of Existing K. Short Inpatient Hospital Stays b. Proposed Changes to the MS–LTC–DRGs Measures in the Hospital IQR Program V. Proposed Changes to the IPPS for Capital- for FY 2016 a. Proposed Refinement of Hospital 30-Day, Related Costs 3. Development of the Proposed FY 2016 All-Cause, Risk-Standardized Mortality A. Overview MS–LTC–DRG Relative Weights Rate (RSMR) Following Pneumonia B. Additional Provisions a. General Overview of the Development of Hospitalization (NQF #0468) Measure 1. Exception Payments the MS–LTC–DRG Relative Weights Cohort 2. New Hospitals b. Development of the Proposed MS–LTC– b. Proposed Refinement of Hospital 30- 3. Hospitals Located in Puerto Rico DRG Relative Weights for FY 2016 Day, All-Cause, Risk-Standardized C. Proposed Annual Update for FY 2016 c. Data Readmission Rate (RSRR) Following VI. Proposed Changes for Hospitals Excluded d. Hospital-Specific Relative Value (HSRV) Pneumonia Hospitalization (NQF #0468) From the IPPS Methodology Measure Cohort VII. Proposed Changes to the Long-Term Care e. Treatment of Severity Levels in 7. Proposed Additional Hospital IQR Hospital Prospective Payment System Developing the Proposed MS–LTC–DRG Program Measures for the FY 2018 (LTCH PPS) for FY 2016 Relative Weights Payment Determination and Subsequent A. Background of the LTCH PPS f. Proposed Low-Volume MS–LTC–DRGs Years S2 1. Legislative and Regulatory Authority g. Steps for Determining the Proposed FY a. Hospital Survey on Patient Safety SAL 2. Criteria for Classification as an LTCH 2016 MS–LTC–DRG Relative Weights Culture O P a. Classification as an LTCH D. Proposed Changes to the LTCH PPS b. Clinical Episode-Based Payment O PR b. Hospitals Excluded From the LTCH PPS Standard Payment Rates for FY 2016 Measures with 3. Limitation on Charges to Beneficiaries 1. Overview of Development of the LTCH c. Hospital-Level, Risk-Standardized OD 4. Administrative Simplification PPS Standard Federal Payment Rates Payment Associated With a 90-Day PR Compliance Act (ASCA) and Health 2. Proposed FY 2016 LTCH PPS Annual Episode-of-Care for Elective Primary VN1 Insurance Portability and Accountability Market Basket Update Total Hip Arthroplasty (THA) and/or T SP Act (HIPAA) Compliance a. Overview Total Knee Arthroplasty (TKA) K3 S D tkelley on VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00007 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 24330 Federal Register/Vol. 80, No. 83/Thursday, April 30, 2015/Proposed Rules d. Excess Days in Acute Care After 13. Public Display Requirements for the FY Domain of Skin Integrity and Changes in Hospitalization for Acute Myocardial 2018 Payment Determination and Skin Integrity: Percent of Residents or Infarction Subsequent Years Patients With Pressure Ulcers That Are e. Excess Days in Acute Care After 14. Reconsideration and Appeal New or Worsened (Short Stay) (NQF Hospitalization for Heart Failure Procedures for the FY 2018 Payment #0678) f. Summary of Previously Adopted and Determination and Subsequent Years c. Proposal To Address the IMPACT Act of Proposed Hospital IQR Program Measure 15. Hospital IQR Program Extraordinary 2014: Quality Measure Addressing the Set for the FY 2018 Payment Circumstances Extensions or Exemptions Domain of Incidence of Major Falls: Determination and Subsequent Years B. PPS-Exempt Cancer Hospital Quality Application of Percent of Residents 8. Electronic Clinical Quality Measures Reporting (PCHQR) Program Experiencing One or More Falls With 1. Statutory Authority Major Injury (Long Stay) (NQF #0674) a. Previously Adopted Voluntarily 2. Proposed Removal of Six Surgical Care d. Proposal To Address the IMPACT Act of Reported Electronic Clinical Quality Improvement Project (SCIP) Measures 2014: Quality Measure Addressing the Measures for the FY 2017 Payment From the PCHQR Program Beginning Domain of Functional Status, Cognitive Determination With Fourth Quarter (Q4) 2015 Function, and Changes in Function and b. Clarification of the Venous Discharges and for Subsequent Years Cognitive Function: Application of Thromboembolism (VTE) Prophylaxis 3. Proposed New Quality Measures Percent of LTCH Patients With an (STK–01) Measure (NQF #0434) Beginning With the FY 2018 Program Admission and Discharge Functional c. Proposed Requirements for Hospitals To a. Considerations in the Selection of Assessment and a Care Plan That Report Electronic Clinical Quality Quality Measures Addresses Function (NQF #2631; Under Measures for the FY 2018 Payment b. Summary of Proposed New Measures NQF Review) Determination and Subsequent Years c. CDC NHSN Facility-Wide Inpatient 7. LTCH QRP Quality Measures for the FY 9. Future Considerations for Electronically Hospital-Onset Clostridium difficile (C. 2019 Payment Determination and Specified Measures: Consideration To difficile) Infection (CDI) Outcome Subsequent Years Implement a New Type of Measure That Measure (NQF #1717) 8. LTCH QRP Quality Measures and Utilizes Core Clinical Data Elements d. CDC NHSN Facility-Wide Inpatient Concepts Under Consideration for Future a. Background Hospital-Onset Methicillin-Resistant Years b. Overview of Core Clinical Data Elements Staphylococcus Aureus (MSRA) 9. Form, Manner, and Timing of Quality c. Core Clinical Data Elements Bacteremia Outcome Measure (NQF Data Submission for the FY 2016 Development #1716) Payment Determinations and Subsequent d. Core Clinical Data Elements Feasibility e. CDC NHSN Influenza Vaccination Years Testing Using Readmission and Coverage Among Healthcare Personnel a. Background Mortality Models (HCP) Measure (NQF #0431) (CDC NHSN b. Proposed Timing for New LTCHs To e. Use of Core Clinical Data Elements in HCP Measure) Begin Reporting Data to CMS for the FY Hospital Quality Measures for the 4. Possible New Quality Measure Topics 2017 Payment Determinations and Hospital IQR Program for Future Years Subsequent Years f. Content Exchange Standard 5. Maintenance of Technical Specifications c. Proposed Revisions to Previously Considerations for Core Clinical Data for Quality Measures Adopted Data Submission Timelines Elements 6. Public Display Requirements Under the LTCH QRP for the FY 2017 10. Form, Manner, and Timing of Quality a. Background and FY 2018 Payment Determinations Data Submission b. Proposed Additional Public Display and Subsequent Years and Proposed a. Background Requirements Data Collection and Data Submission b. Procedural Requirements for the FY 7. Form, Manner, and Timing of Data Timelines for Quality Measures Submission Proposed in This Proposed Rule 2018 Payment Determination and a. Background 10. Previously Adopted LTCH QRP Data Subsequent Years b. Reporting Requirements for the Completion Thresholds for the FY 2016 c. Data Submission Requirements for Proposed New Measures: CDC NHSN Payment Determination and Subsequent Chart-Abstracted Measures CDI (NQF #1717), CDC NHSN MRSA Years d. Alignment of the Medicare EHR (NQF #1716), and CDC NHSN HCP (NQF 11. Future LTCH QRP Data Validation Incentive Program Reporting for Eligible #0431) Measures Process Hospitals and CAHs With the Hospital C. Long-Term Care Hospital Quality 12. Proposed Public Display of Quality IQR Program Reporting Program (LTCH QRP) Measure Data for the LTCH QRP e. Sampling and Case Thresholds for the 1. Background and Statutory Authority 13. Previously Adopted and Proposed FY 2018 Payment Determination and 2. General Considerations Used for LTCH QRP Reconsideration and Appeals Subsequent Years Selection, Resource Use, and Other Procedures for the FY 2017 Payment f. HCAHPS Requirements for the FY 2018 Quality Measures for the LTCH QRP Determination and Subsequent Years Payment Determination and Subsequent 3. Policy for Retention of LTCH QRP 14. Previously Adopted and Proposed Years Measures Adopted for Previous Payment LTCH QRP Submission Exception and g. Data Submission Requirements for Determinations Extension Requirements for the FY 2017 Structural Measures for the FY 2018 4. Policy for Adopting Changes to LTCH Payment Determination and Subsequent Payment Determination and Subsequent QRP Measures Years Years 5. Previously Adopted Quality Measures D. Clinical Quality Measurement for h. Data Submission and Reporting a. Previously Adopted Quality Measures Eligible Hospitals and Critical Access Requirements for Healthcare-Associated for the FY 2015 and FY 2016 Payment Hospitals Participating in the EHR Infection (HAI) Measures Reported via Determinations and Subsequent Years Incentive Programs in 2016 NHSN b. Previously Adopted Quality Measures 1. Background 11. Proposed Modifications to the Existing for the FY 2017 and FY 2018 Payment 2. CQM Reporting for the Medicare and Processes for Validation of Hospital IQR Determinations and Subsequent Years Medicaid EHR Incentive Programs in S2 Program Data 6. Previously Adopted LTCH QRP Quality 2016 SAL a. Background Measures for the FY 2018 Payment a. Background O OP b. Proposed Modifications to the Existing Determinations and Subsequent Years b. Proposed CQM Reporting Period for the PR Processes for Validation of Chart- a. Proposal To Reflect NQF Endorsement: Medicare and Medicaid EHR Incentive with Abstracted Hospital IQR Program Data All-Cause Unplanned Readmission Programs for CY 2016 OD 12. Data Accuracy and Completeness Measure for 30 Days Post-Discharge c. CQM Form and Method for the Medicare PR Acknowledgement Requirements for the From LTCHs (NQF #2512) EHR Incentive Programs for 2016 VN1 FY 2018 Payment Determination and b. Proposal To Address the IMPACT Act of 3. Certified EHR Technology for CQMs for T SP Subsequent Years 2014: Quality Measure Addressing the the EHR Incentive Programs in 2016 K3 S D tkelley on VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00008 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 Federal Register/Vol. 80, No. 83/Thursday, April 30, 2015/Proposed Rules 24331 a. Edition of Certified EHR Technology 3. Proposed Labor-Related Share for the 1. General Considerations Requirements for 2016 LTCH PPS Standard Federal Payment 2. Results b. ‘‘CQM—Report’’ Certification Criterion Rate J. Effects of Proposed Payment Rate in ONC’s 2015 Edition Proposed Rule 4. Proposed Wage Index for FY 2016 for the Changes and Proposed Policy Changes 4. CQM Development and Certification LTCH PPS Standard Federal Payment Under the LTCH PPS Cycle Rate 1. Introduction and General Considerations IX. MedPAC Recommendations 5. Proposed Budget Neutrality Adjustment 2. Impact on Rural Hospitals X. Other Required Information for Proposed Changes to the LTCH PPS 3. Anticipated Effects of Proposed LTCH A. Requests for Data From the Public Standard Federal Payment Rate Area PPS Payment Rate Changes and B. Collection of Information Requirements Wage Level Adjustment Proposed Policy Changes 1. Statutory Requirement for Solicitation of C. Proposed LTCH PPS Cost-of-Living 4. Effect on the Medicare Program Comments Adjustment (COLA) for LTCHs Located 5. Effect on Medicare Beneficiaries 2. ICRs for Add-On Payments for New in Alaska and Hawaii K. Effects of Proposed Requirements for Services and Technologies D. Proposed Adjustment for LTCH PPS Hospital Inpatient Quality Reporting 3. ICRs for the Proposed Occupational Mix High-Cost Outlier (HCO) Cases (IQR) Program Adjustment to the Proposed FY 2016 1. Overview L. Effects of Proposed Requirements for the Wage Index (Hospital Wage Index 2. Determining Proposed LTCH CCRs PPS-Exempt Cancer Hospital Quality Occupational Mix Survey) Under the LTCH PPS Reporting (PCHQR) Program for FY 2016 4. Hospital Applications for Geographic 3. Proposed High-Cost Outlier Payments M. Effects of Proposed Requirements for Reclassifications by the MGCRB for LTCH PPS Standard Federal Payment the LTCH Quality Reporting Program 5. ICRs for the Hospital Inpatient Quality Rate Cases (LTCH QRP) for FY 2016 Through FY Reporting (IQR) Program 4. Proposed High-Cost Outlier Payments 2020 6. ICRs for PPS-Exempt Cancer Hospital for Site Neutral Payment Rate Cases N. Effects of Proposed Changes to Clinical Quality Reporting (PCHQR) Program E. Proposed Update to the IPPS Quality Measurement for Eligible 7. ICRs for Hospital Value-Based Comparable/Equivalent Amounts To Hospitals and Critical Access Hospitals Purchasing (VBP) Program Reflect the Statutory Changes to the IPPS Participating in the EHR Incentive 8. ICRs for the Long-Term Care Hospital DSH Payment Adjustment Methodology Programs in 2016 Quality Reporting Program (LTCHQR) F. Computing the Proposed Adjusted LTCH II. Alternatives Considered C. Response to Comments PPS Federal Prospective Payments for III. Overall Conclusion Regulation Text FY 2016 A. Acute Care Hospitals Addendum—Proposed Schedule of VI. Tables Referenced in This Proposed Rule Standardized Amounts, Update Factors, and Available Through the Internet on B. LTCHs and Rate-of-Increase Percentages the CMS Web site IV. Accounting Statements and Tables Effective With Cost Reporting Periods Appendix A—Economic Analyses A. Acute Care Hospitals Beginning on or After October 1, 2015 I. Regulatory Impact Analysis B. LTCHs and Proposed Payment Rates for LTCHs A. Introduction V. Regulatory Flexibility Act (RFA) Analysis Effective With Discharges Occurring on B. Need VI. Impact on Small Rural Hospitals or After October 1, 2015 C. Objectives of the IPPS VII. Unfunded Mandate Reform Act (UMRA) I. Summary and Background D. Limitations of Our Analysis Analysis II. Proposed Changes to the Prospective E. Hospitals Included in and Excluded VIII. Executive Order 12866 Payment Rates for Hospital Inpatient From the IPPS Appendix B: Recommendation of Update Operating Costs for Acute Care Hospitals F. Effects on Hospitals and Hospital Units Factors for Operating Cost Rates of for FY 2016 Excluded From the IPPS Payment for Inpatient Hospital Services A. Calculation of the Adjusted G. Quantitative Effects of the Proposed I. Background Standardized Amount Policy Changes Under the IPPS for II. Proposed Inpatient Hospital Updates for B. Adjustments for Area Wage Levels and Operating Costs FY 2016 Cost-of-Living 1. Basis and Methodology of Estimates A. Proposed FY 2016 Inpatient Hospital C. Proposed MS–DRG Relative Weights 2. Analysis of Table I Update D. Calculation of the Prospective Payment 3. Impact Analysis of Table II B. Proposed Update for SCHs for FY 2016 Rates H. Effects of Other Proposed Policy C. Proposed FY 2016 Puerto Rico Hospital III. Proposed Changes to Payment Rates for Changes Update Acute Care Hospital Inpatient Capital- 1. Effects of Proposed Policy on MS–DRGs D. Proposed Update for Hospitals Excluded Related Costs for FY 2016 for Preventable HACs, Including From the IPPS for FY 2016 A. Determination of Federal Hospital Infections E. Proposed Update for LTCHs for FY 2016 Inpatient Capital-Related Prospective 2. Effects of Proposed Policy Relating to III. Secretary’s Recommendation Payment Rate Update New Medical Service and Technology IV. MedPAC Recommendation for Assessing B. Calculation of the Proposed Inpatient Add-On Payments Payment Adequacy and Updating Capital-Related Prospective Payments for 3. Effects of Proposed Changes in Medicare Payments in Traditional Medicare FY 2016 DSH Payments for FY 2016 I. Executive Summary and Background C. Capital Input Price Index 4. Effects of Proposed Reductions Under IV. Proposed Changes to Payment Rates for the Hospital Readmissions Reduction A. Executive Summary Excluded Hospitals: Rate-of-Increase Program Percentages for FY 2016 5. Effects of Proposed Changes Under the 1. Purpose and Legal Authority V. Proposed Updates to the Payment Rates FY 2016 Hospital Value-Based This proposed rule would make for the LTCH PPS for FY 2016 Purchasing (VBP) Program A. Proposed LTCH PPS Standard Federal 6. Effects of Proposed Changes to the HAC payment and policy changes under the Rate for FY 2016 Reduction Program for FY 2016 Medicare inpatient prospective payment 1. Background 7. Effects of Proposed Elimination of the systems (IPPS) for operating and capital- S2 2. Development of the Proposed FY 2016 Simplified Cost Allocation Methodology related costs of acute care hospitals as OSAL LTCH PPS Standard Federal Rate 8. Effects of Implementation of Rural well as for certain hospitals and hospital OP B. Proposed Adjustment for Area Wage Community Hospital Demonstration units excluded from the IPPS. In OD with PR 1. LFBeeavdceeklrgsar lUo Punandydem r ethnet RLaTtCe Hfo Pr PFSY S2t0a1n6d ard 9. PMErfSofe–gcrDtasRm oG fs P Sruopbjoescetd t oC Phoanstgaecsu ttoe LCiasrte o f apdodliictyio cnh, aitn wgeosu flodr minapkaet ipenayt mhoesnpti atanld PR 2. Proposed Geographic Classifications Transfer and DRG Special Pay Policy services provided by long-term care VN1 (Labor Market Areas) for the LTCH PPS I. Effects of Proposed Changes in the hospitals (LTCHs) under the long-term T SP Standard Federal Payment Rate Capital IPPS care hospital prospective payment K3 S D tkelley on VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00009 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 24332 Federal Register/Vol. 80, No. 83/Thursday, April 30, 2015/Proposed Rules system (LTCH PPS). It also would make Disease Control and Prevention (CDC), the Affordable Care Act, which policy changes to programs associated at least two conditions that: (a) Are high establishes the ‘‘Hospital Readmissions with Medicare IPPS hospitals, IPPS- cost, high volume, or both; (b) are Reduction Program’’ effective for excluded hospitals, and LTCHs. assigned to a higher paying MS–DRG discharges from an ‘‘applicable Under various statutory authorities, when present as a secondary diagnosis hospital’’ beginning on or after October we are proposing to make changes to the (that is, conditions under the MS–DRG 1, 2012, under which payments to those Medicare IPPS, to the LTCH PPS, and to system that are complications or hospitals under section 1886(d) of the other related payment methodologies comorbidities (CCs) or major Act will be reduced to account for and programs for FY 2016 and complications or comorbidities (MCCs); certain excess readmissions. subsequent fiscal years. These statutory and (c) could reasonably have been • Section 1886(r) of the Act, as added authorities include, but are not limited prevented through the application of by section 3133 of the Affordable Care to, the following: evidence-based guidelines. Section Act, which provides for a reduction to • Section 1886(d) of the Social 1886(d)(4)(D) of the Act also specifies disproportionate share hospital Security Act (the Act), which sets forth that the list of conditions may be payments under section 1886(d)(5)(F) of a system of payment for the operating revised, again in consultation with CDC, the Act and for a new uncompensated costs of acute care hospital inpatient from time to time as long as the list care payment to eligible hospitals. stays under Medicare Part A (Hospital contains at least two conditions. Section Specifically, section 1886(r) of the Act Insurance) based on prospectively set 1886(d)(4)(D)(iii) of the Act requires that now requires that, for fiscal year 2014 rates. Section 1886(g) of the Act requires hospitals, effective with discharges and each subsequent fiscal year, that, instead of paying for capital-related occurring on or after October 1, 2007, subsection (d) hospitals that would costs of inpatient hospital services on a submit information on Medicare claims otherwise receive a disproportionate reasonable cost basis, the Secretary use specifying whether diagnoses were share hospital payment made under a prospective payment system (PPS). present on admission (POA). Section section 1886(d)(5)(F) of the Act will • Section 1886(d)(1)(B) of the Act, 1886(d)(4)(D)(i) of the Act specifies that receive two separate payments: (1) 25 which specifies that certain hospitals effective for discharges occurring on or percent of the amount they previously and hospital units are excluded from the after October 1, 2008, Medicare no would have received under section IPPS. These hospitals and units are: longer assigns an inpatient hospital 1886(d)(5)(F) of the Act for DSH (‘‘the Rehabilitation hospitals and units; discharge to a higher paying MS–DRG if empirically justified amount’’), and (2) LTCHs; psychiatric hospitals and units; a selected condition is not POA. an additional payment for the DSH children’s hospitals; cancer hospitals; • Section 1886(a)(4) of the Act, which hospital’s proportion of uncompensated and short-term acute care hospitals specifies that costs of approved care, determined as the product of three located in the Virgin Islands, Guam, the educational activities are excluded from factors. These three factors are: (1) 75 Northern Mariana Islands, and the operating costs of inpatient hospital percent of the payments that would American Samoa. Religious nonmedical services. Hospitals with approved otherwise be made under section health care institutions (RNHCIs) are graduate medical education (GME) 1886(d)(5)(F) of the Act; (2) 1 minus the also excluded from the IPPS. programs are paid for the direct costs of percent change in the percent of • Sections 123(a) and (c) of Public GME in accordance with section 1886(h) individuals under the age of 65 who are Law 106–113 and section 307(b)(1) of of the Act. A payment for indirect uninsured (minus 0.1 percentage points Public Law 106–554 (as codified under medical education (IME) is made under for FY 2014, and minus 0.2 percentage section 1886(m)(1) of the Act), which section 1886(d)(5)(B) of the Act. points for FY 2015 through FY 2017); provide for the development and • Section 1886(b)(3)(B)(viii) of the and (3) a hospital’s uncompensated care implementation of a prospective Act, which requires the Secretary to amount relative to the uncompensated payment system for payment for reduce the applicable percentage care amount of all DSH hospitals inpatient hospital services of long-term increase in payments to a subsection (d) expressed as a percentage. care hospitals (LTCHs) described in hospital for a fiscal year if the hospital • Section 1886(m)(6) of the Act, as section 1886(d)(1)(B)(iv) of the Act. does not submit data on measures in a added by section 1206(a)(1) of the • Sections 1814(l), 1820, and 1834(g) form and manner, and at a time, Pathway for SGR Reform Act of 2013 of the Act, which specify that payments specified by the Secretary. (Pub. L. 113–67), which provided for the are made to critical access hospitals • Section 1886(o) of the Act, which establishment of patient criteria for (CAHs) (that is, rural hospitals or requires the Secretary to establish a payment under the LTCH PPS for facilities that meet certain statutory Hospital Value-Based Purchasing (VBP) implementation beginning in FY 2016. requirements) for inpatient and Program under which value-based • Section 1206(b)(1) of the Pathway outpatient services and that these incentive payments are made in a fiscal for SGR Reform Act of 2013, which payments are generally based on 101 year to hospitals meeting performance further amended section 114(c) of the percent of reasonable cost. standards established for a performance MMSEA, as amended by section 4302(a) • Section 1866(k) of the Act, as added period for such fiscal year. of the ARRA and sections 3106(c) and by section 3005 of the Affordable Care • Section 1886(p) of the Act, as added 10312(a) of the Affordable Care Act, by Act, which establishes a quality by section 3008 of the Affordable Care retroactively reestablishing and reporting program for hospitals Act, which establishes an adjustment to extending the statutory moratorium on described in section 1886(d)(1)(B)(v) of hospital payments for hospital-acquired the full implementation of the 25- the Act, referred to as ‘‘PPS-Exempt conditions (HACs), or a Hospital- percent threshold payment adjustment OSALS2 Ca•ncSeerc Htioosnp 1it8a8ls6.(’d’ )(4)(D) of the Act, APrcoqguriarmed, uCnodnedri twiohnic (hH pAaCy)m Reendtus cttoi on ppoolliiccyy uwnildl ebre t hine eLfTfeCcHt f PorP S9 ysoe atrhsa t the P RO which addresses certain hospital- applicable hospitals are adjusted to (except for ‘‘grandfathered’’ hospital- D with P aincfqeucitrieodn sc.o Snedcittiioonn s1 8(H86A(Cds)()4, )i(nDc)l uodf itnhge pacroqvuiidreed a cno inndcietniotinvse. to reduce hospital- wpeirthmiann-heonstlpyi teaxlse m(Hpwt fHros)m, w thhiisc hp oalriec y); RO Act specifies that, by October 1, 2007, • Section 1886(q) of the Act, as added and section 1206(b)(2) (as amended by P N1 the Secretary was required to select, in by section 3025 of the Affordable Care section 112(b) of Pub. L. 113–93), which V T SP consultation with the Centers for Act and amended by section 10309 of together further amended section 114(d) K3 S D tkelley on VerDate Sep<11>2014 18:20 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00010 Fmt 4701 Sfmt 4702 E:\FR\FM\30APP2.SGM 30APP2 Federal Register/Vol. 80, No. 83/Thursday, April 30, 2015/Proposed Rules 24333 of the MMSEA, as amended by section rates in any one year. Therefore, For FY 2016, we are proposing to 4302(a) of the ARRA and sections consistent with the policies that we adopt one additional measure beginning 3106(c) and 10312(a) of the Affordable have adopted in many similar cases, we with the FY 2018 program year and one Care Act to establish a new moratoria made a ¥0.8 percent recoupment measure beginning with the FY 2021 (subject to certain defined exceptions) adjustment to the standardized amount program year. We also are proposing to on the development of new LTCHs and in FY 2014 and FY 2015. We are remove two measures beginning with LTCH satellite facilities and a new proposing to make an additional ¥0.8 the FY 2018 program year. In addition, moratorium on increases in the number percent recoupment adjustment to the we are proposing to move one measure of beds in existing LTCHs and LTCH standardized amount in FY 2016. to the Safety domain and to remove the satellite facilities beginning January 1, b. Reduction of Hospital Payments for Clinical Care—Process subdomain and 2015 and ending on September 30, Excess Readmissions rename the Clinical Care—Outcomes 2017; and section 1206(d), which instructs the Secretary to evaluate We are proposing changes in policies subdomain as the Clinical Care domain. to the Hospital Readmissions Reduction Finally, we are signaling our intent to payments to LTCHs classified under Program, which is established under propose in future rulemaking to expand section 1886(b)(1)(C)(iv)(II) of the Act section 1886(q) of the Act, as added by one measure and to update the standard and to adjust payment rates in FY 2015 section 3025 of the Affordable Care Act. population data we use to calculate or FY 2016 under the LTCH PPS, as The Hospital Readmissions Reduction several measures beginning with the FY appropriate, based upon the evaluation Program requires a reduction to a 2019 program year. findings. • Section 1886(m)(5)(D)(iv) of the hospital’s base operating DRG payment d. Hospital-Acquired Condition (HAC) to account for excess readmissions of Act, as added by section 1206 (c) of the Reduction Program selected applicable conditions. For FYs Pathway for SGR Reform Act of 2013, 2013 and 2014, these conditions are which provides for the establishment, Section 1886(p) of the Act, as added acute myocardial infarction, heart no later than October 1, 2015, of a under section 3008(a) of the Affordable failure, and pneumonia. For FY 2014, functional status quality measure under Care Act, establishes an incentive to we established additional exclusions to the LTCH QRP for change in mobility hospitals to reduce the incidence of the three existing readmission measures among inpatients requiring ventilator hospital-acquired conditions by (that is, the excess readmission ratio) to support. requiring the Secretary to make an • Section 1899B of the Act, as added account for additional planned readmissions. We also established adjustment to payments to applicable by the Improving Medicare Post-Acute additional readmissions measures, hospitals effective for discharges Care Transformation Act of 2014 (the chronic obstructive pulmonary disease beginning on October 1, 2014 and for IMPACT Act of 2014), which imposes (COPD), and total hip arthroplasty and subsequent program years. This 1- new data reporting requirements for total knee arthroplasty (THA/TKA), to percent payment reduction applies to a certain postacute care providers, be used in the Hospital Readmissions hospital whose ranking is in the top including LTCHs. Reduction Program for FY 2015 and quartile (25 percent) of all applicable 2. Summary of the Major Provisions future years. We expanded the hospitals, relative to the national a. MS–DRG Documentation and Coding readmissions measures for FY 2017 and average, of conditions acquired during Adjustment future years by adding a measure of the applicable period and on all of the patients readmitted following coronary hospital’s discharges for the specified Section 631 of the American Taxpayer artery bypass graft (CABG) surgery. fiscal year. The amount of payment Relief Act (ATRA, Pub. L. 112–240) In this proposed rule, we are shall be equal to 99 percent of the amended section 7(b)(1)(B) of Public proposing a refinement to the amount of payment that would Law 110–90 to require the Secretary to pneumonia readmissions measure, otherwise apply to such discharges make a recoupment adjustment to the which would expand the measure under section 1886(d) or 1814(b)(3) of standardized amount of Medicare cohort for the FY 2017 payment the Act, as applicable. payments to acute care hospitals to determination and subsequent years. In account for changes in MS–DRG addition, we are proposing to adopt an In this proposed rule, we are documentation and coding that do not extraordinary circumstance exception proposing three changes to existing reflect real changes in case-mix, totaling policy that would align with existing Hospital-Acquired Condition Reduction $11 billion over a 4-year period of FYs extraordinary circumstance exception Program policies: (1) An expansion to 2014, 2015, 2016, and 2017. This policies for other IPPS quality reporting the population covered by the central adjustment represents the amount of the and payment programs and would allow line-associated bloodstream infection increase in aggregate payments as a hospitals that experience an (CLABSI) and catheter-associated result of not completing the prospective extraordinary circumstance (such as a urinary tract infection (CAUTI) adjustment authorized under section hurricane or flood) to request a waiver measures to include patients in select 7(b)(1)(A) of Public Law 110–90 until for use of data from the affected time nonintensive care unit sites within a FY 2013. Prior to the ATRA, this period. hospital; (2) an adjustment to the amount could not have been recovered c. Hospital Value-Based Purchasing relative contribution of each domain to under Public Law 110–90. (VBP) Program the Total HAC Score which is used to While our actuaries estimated that a S2 ¥9.3 percent adjustment to the Section 1886(o) of the Act requires the determine if a hospital will receive the AL payment adjustment; and (3) a policy OS standardized amount would be Secretary to establish a Hospital VBP P that would align with existing O necessary if CMS were to fully recover Program under which value-based R D with P tsheec t$io1n1 6b3il1li oofn t rheec AouTpRmAe innt orenqeu yireeadr, biyt iynecaern toti vheo sppaiytmalse nbtass aerde omna tdhee iirn a fiscal epxotlriacoiersd ifnora royt hceirrc IuPmPSst aqnucaeli teyx creeppotirotnin g RO is often our practice to delay or phase performance on measures established and payment programs and would allow P N1 in rate adjustments over more than one for a performance period for such fiscal hospitals to request a waiver for use of V SPT year, in order to moderate the effects on year. data from the affected time period. 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