Final Rule with Comment Period on Medicare OPPS - Ropes & Gray

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Federal Register / Vol. 76, No. 230 / Wednesday, November 30, 2011 / <strong>Rule</strong>s and Regulations74123jlentini on DSK4TPTVN1PROD <strong>with</strong> RULES2SUPPLEMENTARY INFORMATION:Inspection of Public <strong>Comment</strong>s: Allcomments received before the close ofthe comment period are available forviewing by the public, including anypersonally identifiable or confidentialbusiness information that is included ina comment. We post all commentsreceived before the close of thecomment period on the following Website as soon as possible after they havebeen received: http://www.regulations.gov. Follow the searchinstructions on that Web site to viewpublic comments.<strong>Comment</strong>s received timely will alsobe available for public inspection,generally beginning approximately3 weeks after publication of the rule, atthe headquarters of the Centers forMedicare & Medicaid Services, 7500Security Boulevard, Baltimore, MD21244, on Monday through Friday ofeach week from 8:30 a.m. to 4 p.m. EST.To schedule an appointment to viewpublic comments, phone 1–(800) 743–3951.Electronic AccessThis Federal Register document isalso available from the Federal Registeronline database through Federal DigitalSystem (FDsys), a service of the U.S.Government Printing Office. Thisdatabase can be accessed via theinternet at http://www.gpo.gov/fdsys/.Addenda Available Only Through theInternet on the CMS Web SiteIn the past, a majority of the Addendareferred to throughout the preamble ofour OPPS/ASC proposed and final ruleswere published in the Federal Registeras part of the annual rulemakings.However, beginning <strong>with</strong> the CY 2012proposed rule, all of the Addenda willno longer appear in the Federal Registeras part of the annual OPPS/ASCproposed and final rules to decreaseadministrative burden and reduce costsassociated <strong>with</strong> publishing lengthytables. Instead, these Addenda will bepublished and available only on theCMS Web site. The Addenda relating tothe OPPS are available at:http://www.cms.gov/HospitalOutpatientPPS. The Addenda relating tothe ASC payment system are availableat: http://www.cms.gov/ASCPayment/.For complete details on the availabilityof the Addenda referenced in this finalrule <strong>with</strong> comment period, we referreaders to section XVII. Readers whoexperience any problems accessing anyof the Addenda that are posted on theCMS Web site identified above shouldcontact Charles Braver at (410) 786–0378.Alphabetical List of AcronymsAppearing in This Federal RegisterDocumentACEP American College of EmergencyPhysiciansAHA American Hospital AssociationAHIMA American Health InformationManagement AssociationAHRQ Agency for Healthcare Research andQualityAMA American Medical AssociationAMP Average Manufacturer PriceAOA American Osteopathic AssociationAPC Ambulatory Payment ClassificationARRA American Recovery andReinvestment Act of 2009, Public Law111–5ASC Ambulatory Surgical CenterASP Average Sales PriceAWP Average Wholesale PriceBBA Balanced Budget Act of 1997, PublicLaw 105–33BBRAMedicare, Medicaid, and SCHIP[State Children’s Health InsuranceProgram] Balanced Budget Refinement Actof 1999, Public Law 106–113BIPA Medicare, Medicaid, and SCHIPBenefits Improvement and Protection Actof 2000, Public Law 106–554BLS Bureau of Labor StatisticsCAH Critical Access HospitalCAP Competitive Acquisition ProgramCBSA Core-Based Statistical AreaCCN CMS Certification NumberCCR Cost-to-Charge RatioCDC Centers for Disease ControlCERT Comprehensive Error Rate TestingCLFS Clinical Laboratory Fee ScheduleCMHC Community Mental Health CenterCMS Centers for Medicare & MedicaidServicesCPT Current Procedural Terminology(copyrighted by the American MedicalAssociation)CQM Clinical Quality MeasureCR Cardiac RehabilitationCY Calendar YearDFO Designated Federal OfficialDHS Designated Health ServiceDRA Deficit Reduction Act of 2005, PublicLaw 109–171DSH Disproportionate Share HospitalEACH Essential Access CommunityHospitalE/M Evaluation and ManagementEHR Electronic Health RecordESRD End-Stage Renal DiseaseFACA Federal Advisory Committee Act,Public Law 92–463FAR Federal Acquisition RegulationsFDA Food and Drug AdministrationFFS Fee-for-ServiceFSS Federal Supply ScheduleFY Fiscal YearGAO Government Accountability OfficeHAC Hospital-Acquired ConditionHAI Healthcare-Associated InfectionHCAHPS Hospital Consumer Assessment ofHealthcare Providers and SystemsHCERA Health Care and EducationReconciliation Act of 2010, Public Law111–152HCP Healthcare PersonnelHCPCS Healthcare Common ProcedureCoding SystemVerDate Mar2010 17:08 Nov 29, 2011 Jkt 226001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 E:\FR\FM\30NOR2.SGM 30NOR2HCRIS Hospital Cost Report InformationSystemHHA Home Health AgencyHIPAA Health Insurance Portability andAccountability Act of 1996, Public Law104–191HOPD Hospital Outpatient DepartmentHospital OQR Hospital Outpatient QualityReportingICR Intensive Cardiac RehabilitationIDE Investigational Device ExemptionIHS Indian Health ServiceIQR Inpatient Quality ReportingI/OCE Integrated Outpatient Code EditorIOL Intraocular LensIPPS [Hospital] Inpatient ProspectivePayment SystemMAC Medicare Administrative ContractorMedPAC Medicare Payment AdvisoryCommissionMIEA–TRHCA Medicare Improvements andExtension Act under Division B, Title I ofthe Tax Relief Health Care Act of 2006,Public Law 109–432MIPPA Medicare Improvements for Patientsand Providers Act of 2008, Public Law110–275MMA Medicare Prescription Drug,Improvement, and Modernization Act of2003, Public Law 108–173MMEA Medicare and Medicaid ExtendersAct of 2010, Public Law 111–309MMSEA Medicare, Medicaid, and SCHIPExtension Act of 2007, Public Law 110–173MPFS Medicare Physician Fee ScheduleMSA Metropolitan Statistical AreaNCCI National Correct Coding InitiativeNHSN National Healthcare Safety NetworkNCD National Coverage DeterminationNPP Nonphysician practitionerNQF National Quality ForumNTIOL New Technology Intraocular LensOIG [HHS] Office of the Inspector GeneralOMB Office of Management and BudgetOPD [Hospital] Outpatient DepartmentOPPS [Hospital] Outpatient ProspectivePayment SystemOQR Outpatient Quality ReportingPBD Provider-Based DepartmentPHP Partial Hospitalization ProgramPPI Producer Price IndexPPS Prospective Payment SystemPR Pulmonary RehabilitationPRA Paperwork Reduction ActQAPI Quality Assessment and PerformanceImprovementQIO Quality Improvement OrganizationRAC Recovery Audit ContractorRFA Regulatory Flexibility ActRHHI Regional Home Health IntermediarySBA Small Business AdministrationSCH Sole Community HospitalSDP Single Drug PricerSI Status IndicatorTEP Technical Expert PanelTOPs Transitional Outpatient PaymentsVBP Value-Based PurchasingWAC Wholesale Acquisition CostIn this document, we address twopayment systems under the Medicareprogram: the OPPS and the ASCpayment system. In addition, we aremaking changes to the rules governinglimitations on certain physicianreferrals to hospitals in which
jlentini on DSK4TPTVN1PROD <strong>with</strong> RULES274124 Federal Register / Vol. 76, No. 230 / Wednesday, November 30, 2011 / <strong>Rule</strong>s and Regulationsphysicians have an ownership orinvestment interest, the provideragreement regulations on patientnotification requirements, and the rulesgoverning the Hospital Inpatient Value-Based Purchasing (VBP) Program. Theprovisions relating to the OPPS areincluded in sections I. through XII.,section XIV., and sections XVII. throughXXI. of this final rule <strong>with</strong> commentperiod. Addenda A, B, C, D1, D2, E, L,M, and N, which relate to the OPPS, arereferenced in section XVII. of this finalrule <strong>with</strong> comment period and areavailable via the Internet on the CMSWeb site at the URL indicated in sectionXVII. The provisions related to the ASCpayment system are included insections XIII., XIV., and XVII. throughXXI. of this final rule <strong>with</strong> commentperiod. Addenda AA, BB, DD1, DD2,and EE, which relate to the ASCpayment system, are referenced insection XVII. of this final rule <strong>with</strong>comment period and are available viathe Internet on the CMS Web site at theURL indicated in section XVII. Theprovisions relating to physician referralsto hospitals in which physicians havean ownership or investment interest andto the provider agreement regulations onpatient notification requirements areincluded in section XV., and theprovisions relating to the HospitalInpatient VBP Program are included insection XVI. of this final rule <strong>with</strong>comment period.Table of ContentsI. Background and Summary of the CY 2012OPPS/ASC Proposed <strong>Rule</strong> and This <strong>Final</strong><strong>Rule</strong> With <strong>Comment</strong> <strong>Period</strong>A. Legislative and Regulatory Authority forthe Hospital Outpatient PerspectivePayment SystemB. Excluded OPPS Services and HospitalsC. Prior <strong>Rule</strong>makingD. Advisory Panel on Ambulatory PaymentClassification (APC) Groups1. Authority of the APC Panel2. Establishment of the APC Panel3. APC Panel Meetings and OrganizationalStructureE. Summary of the Major Contents of theCY 2012 OPPS/ASC Proposed <strong>Rule</strong>1. Updates Affecting OPPS Payments2. OPPS Ambulatory PaymentClassification (APC) Group Policies3. OPPS Payment for Devices4. OPPS Payment Changes for Drugs,Biologicals, and Radiopharmaceuticals5. Estimate of OPPS Transitional Pass-Through Spending for Drugs, Biologicals,Radiopharmaceuticals, and Devices6. OPPS Payment for Hospital OutpatientVisits7. Payment for Partial HospitalizationServices8. Procedures That Would Be Paid Only asInpatient Procedures9. Policies on Supervision Standards forOutpatient Services in Hospitals andCAHs10. OPPS Payment Status and <strong>Comment</strong>Indicators11. OPPS Policy and PaymentRecommendations12. Updates to the Ambulatory SurgicalCenter (ASC) Payment System13. Reporting Quality Data for AnnualPayment Rate Updates14. Changes to EHR Incentive Program forEligible Hospitals and CAHs RegardingElectronic Submission of ClinicalQuality Measures (CQMs)15. Changes to Provisions Relating toPhysician Self-Referral Prohibition andProvider Agreement Regulations onPatient Notification Requirements16. Additional Changes to the HospitalInpatient VBP Program17. Economic and Federalism AnalysesF. Public <strong>Comment</strong>s Received in Responseto the CY 2012 OPPS/ASC Proposed<strong>Rule</strong>G. Public <strong>Comment</strong>s Received on the CY2011 OPPS/ASC <strong>Final</strong> <strong>Rule</strong> With<strong>Comment</strong> <strong>Period</strong>II. Updates Affecting OPPS PaymentsA. Recalibration of APC Relative Weights1. Database Constructiona. Database Source and Methodologyb. Use of Single and Multiple ProcedureClaimsc. Calculation and Use of Cost-to-ChargeRatios (CCRs)2. Data Development Process andCalculation of Median Costsa. Claims Preparationb. Splitting Claims and Creation of‘‘Pseudo’’ Single Procedure Claims(1) Splitting Claims(2) Creation of ‘‘Pseudo’’ Single ProcedureClaimsc. Completion of Claim Records andMedian Cost Calculationsd. Calculation of Single Procedure APCCriteria-Based Median Costs(1) Device-Dependent APCs(2) Blood and Blood Products(3) Allergy Tests (APCs 0370 and 0381)(4) Hyperbaric Oxygen Therapy (APC 0659)(5) Payment for Ancillary OutpatientServices When Patient Expires (APC0375)(6) Endovascular Revascularization of theLower Extremity (APCs 0083, 0229, and0319)(7) Non-Congenital Cardiac Catheterization(APC 0080)(8) Cranial Neurostimulator and Electrodes(APC 0318)(9) Brachytherapy Sourcese. Calculation of Composite APC Criteria-Based Median Costs(1) Extended Assessment and ManagementComposite APCs (APCs 8002 and 8003)(2) Low Dose Rate (LDR) ProstateBrachytherapy Composite APC (APC8001)(3) Cardiac Electrophysiologic Evaluationand Ablation Composite APC (APC 8000)(4) Mental Health Services Composite APC(APC 0034)(5) Multiple Imaging Composite APCs(APCs 8004, 8005, 8006, 8007, and 8008)VerDate Mar2010 17:08 Nov 29, 2011 Jkt 226001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 E:\FR\FM\30NOR2.SGM 30NOR2(6) Cardiac Resynchronization TherapyComposite APC (APCs 0108, 0418, 0655,and 8009)3. Changes to Packaged Servicesa. Backgroundb. Packaging Issues(1) CMS Presentation of FindingsRegarding Expanded Packaging at theFebruary 28–March 1, 2011 and August10–12, 2011 APC Panel Meetings(2) Packaging Recommendations of theAPC Panel at Its February 28–March 1,2011 Meeting(3) Packaging Recommendations of theAPC Panel at Its August 2011 Meeting(4) Other Packaging Proposals and Policiesfor CY 20124. Calculation of OPPS Scaled PaymentWeightsB. Conversion Factor UpdateC. Wage Index ChangesD. Statewide Average Default CCRsE. OPPS Payment to Certain Rural andOther Hospitals1. Hold Harmless Transitional PaymentChanges2. Adjustment for Rural SCHs and EACHsUnder Section 1833(t)(13)(B) of the ActF. OPPS Payments to Certain CancerHospitals Described by Section1886(d)(1)(B)(v) of the Act1. Background2. Study of Cancer Hospital Costs Relativeto Other Hospitals3. CY 2011 Proposed Payment Adjustmentfor Certain Cancer Hospitals4. Proposed CY 2011 Cancer HospitalPayment Adjustment That Was Not<strong>Final</strong>ized5. Payment Adjustment for Certain CancerHospitals for CY 2012G. Hospital Outpatient Outlier Payments1. Background2. Proposed Outlier Calculation3. <strong>Final</strong> Outlier Calculation4. Outlier ReconciliationH. Calculation of an Adjusted MedicarePayment From the National UnadjustedMedicare PaymentI. Beneficiary Copayments1. Background2. OPPS Copayment Policy3. Calculation of an Adjusted CopaymentAmount for an APC GroupIII. OPPS Ambulatory Payment Classification(APC) Group PoliciesA. OPPS Treatment of New CPT and LevelII HCPCS Codes1. Treatment of New Level II HCPCS Codesand Category I CPT Vaccine Codes andCategory III CPT Codes for Which WeSolicited Public <strong>Comment</strong>s in the CY2012 Proposed <strong>Rule</strong>2. Process for New Level II HCPCS Codesand Category I and Category III CPTCodes for Which We Are SolicitingPublic <strong>Comment</strong>s on This CY 2012OPPS/ASC <strong>Final</strong> <strong>Rule</strong> With <strong>Comment</strong><strong>Period</strong>B. OPPS Changes—Variations Within APCs1. Background2. Application of the 2 Times <strong>Rule</strong>3. Exceptions to the 2 Times <strong>Rule</strong>C. New Technology APCs1. Background2. Movement of Procedures From NewTechnology APCs to Clinical APCs
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Final Rule with Comment Period on Medicare OPPS - Ropes & Gray

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