{"description":"Documents matching 'prior authorization non-drug items include'","count":131,"total_pages":7,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=prior+authorization+non-drug+items+include&format=json&page=2","results":[{"title":"Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability Standards and Prior Authorization for Drugs for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, and Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges","type":"Proposed Rule","abstract":"These proposals are intended to improve the electronic exchange of health care data and streamline processes related to prior authorization by increasing the interoperability of systems used across the health care industry. We are proposing new requirements for Medicare Advantage (MA) organizations, state Medicaid fee-for-service (FFS) programs, state Children's Health Insurance Program (CHIP) FFS programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs), including issuers that offer small group market QHPs on the Federally-facilitated Small Business Health Options Program (FF- SHOP) Exchanges (hereinafter referred to as \"small group market QHP issuers on the FF-SHOPs\") (collectively \"impacted payers\"), to make available electronic prior authorization for drugs. We are also proposing to extend many existing interoperability requirements for the prior authorization of non-drug items and services to include prior authorizations for drugs to further reduce patient and provider burden. We are also proposing to require impacted payers to report their application programming interfaces (API) endpoints and related information for the Patient Access, Provider Directory, Provider Access, Payer-to-Payer, and Prior Authorization APIs to CMS. To help assess the impact of our policies, we are proposing to collect API usage metrics. In addition, we are proposing to apply the existing interoperability requirements to small group market QHP issuers on the FF-SHOPs as impacted payers. To improve impacted payers' ability to exchange health information while continuing CMS's drive toward interoperability, we are proposing to require certain Health Level Seven (HL7[supreg]) Fast Healthcare Interoperability Resources (FHIR[supreg]) implementation guides (IGs) that are currently recommended. In addition, HHS is proposing to adopt the HL7 FHIR base standard and certain associated specifications and IGs as the Health Insurance Portability and Accountability Act of 1996 (hereinafter referred to as \"HIPAA\") (Pub. L. 104-191, enacted Aug. 21, 1996) standards for dental, professional, and institutional \"referral certification and authorization\" transactions and \"eligibility for a health plan\" transactions associated with prior authorization. We are proposing to add a definition for \"failure to report,\" which would allow CMS to impose a civil monetary penalty (CMP) on applicable manufacturers or applicable group purchasing organizations (GPOs) if those entities fail to grant CMS timely access to documents for the purposes of an audit. Finally, ONC is using this rulemaking to propose to adopt updated versions of certain health information technology (health IT) standards and specifications for HHS use, such as CMS's interoperability requirements, to support a more robust health IT infrastructure.","document_number":"2026-07205","html_url":"https://www.federalregister.gov/documents/2026/04/14/2026-07205/medicare-and-medicaid-programs-patient-protection-and-affordable-care-act-interoperability-standards","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-14/pdf/2026-07205.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-07205.pdf?1775852111","publication_date":"2026-04-14","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"},{"raw_name":"Office of the Secretary"}],"excerpts":"metrics about <span class=\"match\">prior</span> <span class=\"match\">authorization</span> denials after an extended timeframe and appeals for <span class=\"match\">non-drug</span> <span class=\"match\">items</span> and services and two new metrics about <span class=\"match\">prior</span> <span class=\"match\">authorization</span> approvals after an extended timeframe and appeals for <span class=\"match\">non-drug</span> <span class=\"match\">items</span> and services for expedited <span class=\"match\">prior</span> <span class=\"match\">authorization</span> requests only. The proposed metrics complement existing metrics finalized in the 2024 CMS Interoperability and <span class=\"match\">Prior</span> <span class=\"match\">Authorization</span> final rule about <span class=\"match\">prior</span> <span class=\"match\">authorization</span> approvals after an extended timeframe and appeals for <span class=\"match\">non-drug</span> <span class=\"match\">items</span> for standard <span class=\"match\">prior</span> <span class=\"match\">authorization</span> requests."},{"title":"Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; and Quality Reporting Programs; Including the Hospital Outpatient Quality Reporting Program and Ambulatory Surgical Center Quality Program; Request for Information on Strengthening the Standardization and Comparability of Hospital Price Transparency (HPT) Data; Prior Authorization; Accrediting Organization (AO) Deeming for Emergency Medical Treatment and Labor Act (EMTALA); and Notices of Closure of Teaching Hospitals and Opportunities To Apply for Available Slots","type":"Proposed Rule","abstract":"This proposed rule would revise the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for calendar year 2027 based on our continuing experience with these systems. We also describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment systems. In addition, this proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting Program and the Ambulatory Surgical Center Quality Reporting Program. There are no changes to the Rural Emergency Hospital Quality Reporting Program. We propose to expand the prior authorization requirement to include additional Botulinum Toxin Injection services. We also propose to implement certain provisions of the Consolidated Appropriations Act, 2026, for off-campus outpatient departments of a provider. In addition, this proposed rule announces notices of closure of teaching hospitals and opportunities to apply for available slots. This rule also requests information regarding potential approaches to improve comparability and standardization, particularly for complex contracting methodologies, of the HPT information reported in machine- readable files and consumer-friendly displays. We propose hospital AOs with deeming authority to assess compliance with certain Emergency Medical Treatment and Labor Act (EMTALA) administrative requirements during accreditation and reaccreditation surveys. Finally, we are soliciting comments on a potential separate payment under the Inpatient Prospective Payment System (IPPS) for domestic procurement of personal protective equipment and essential medicines.","document_number":"2026-13656","html_url":"https://www.federalregister.gov/documents/2026/07/07/2026-13656/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-07/pdf/2026-13656.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-13656.pdf?1782996328","publication_date":"2026-07-07","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"acquired drugs. Statute requires that this policy be implemented in a budget neutral manner, so this proposal would increase OPPS payments for <span class=\"match\">non-drug</span> services by an equivalent amount, which is estimated to be an 8.44 percent increase to <span class=\"match\">non-drug</span> service payments for this proposed rule.\n \n \n • Prospective Adjustment to Payments for <span class=\"match\">Non-Drug</span> <span class=\"match\">Items</span> and Services to Offset the Increased Payments for <span class=\"match\">Non-Drug</span> <span class=\"match\">Items</span> and Services Made in CY 2018 Through CY 2022 as a Result of the 340B Payment Policy. \n The Remedy for the 340B-Acquired Drug Payment Policy"},{"title":"Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2026 Rates; Changes to the FY 2025 IPPS Rates Due to Court Decision; Requirements for Quality Programs; and Other Policy Changes; Health Data, Technology, and Interoperability: Electronic Prescribing, Real-Time Prescription Benefit and Electronic Prior Authorization","type":"Rule","abstract":"This final rule revises the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals; makes changes relating to Medicare graduate medical education (GME) for teaching hospitals; updates the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs); updates and makes changes to requirements for certain quality programs; and makes other policy- related changes. We are also finalizing the provisions of the interim final action with comment period regarding the changes to the FY 2025 IPPS rates due to the court decision in Bridgeport Hosp. v. Becerra. Lastly, it finalizes certain updates to the ONC Health Information Technology (IT) Certification Program.","document_number":"2025-14681","html_url":"https://www.federalregister.gov/documents/2025/08/04/2025-14681/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-ipps-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-08-04/pdf/2025-14681.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-14681.pdf?1753992911","publication_date":"2025-08-04","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"},{"raw_name":"Office of the Secretary"}],"excerpts":"ASTP/ONC is finalizing to support electronic <span class=\"match\">prior</span> <span class=\"match\">authorization</span>.\n \n \n (e) New Certification Criteria for Electronic <span class=\"match\">Prior</span> <span class=\"match\">Authorization</span> \n In section III.B.20 of the preamble of the HTI-2 Proposed Rule, ASTP/ONC proposed to adopt a “<span class=\"match\">prior</span> <span class=\"match\">authorization</span> API—provider” criterion in 45 CFR 170.315(g)(34). ASTP/ONC also proposed to adopt a set of HL7® FHIR® implementation guides (IGs) in 45 CFR 170.215 for HHS use, including IGs referenced as part of the proposed criterion for electronic <span class=\"match\">prior</span> <span class=\"match\">authorization</span> and other IGs that support interoperable exchange"},{"title":"Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model","type":"Rule","abstract":"This final rule updates and revises the End-Stage Renal Disease (ESRD) Prospective Payment System for calendar year 2026. This rule also includes updates to the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. In addition, this rule updates the requirements for the ESRD Quality Incentive Program and terminates and modifies requirements for the ESRD Treatment Choices Model.","document_number":"2025-20681","html_url":"https://www.federalregister.gov/documents/2025/11/24/2025-20681/medicare-program-end-stage-renal-disease-prospective-payment-system-payment-for-renal-dialysis","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-11-24/pdf/2025-20681.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-20681.pdf?1763673309","publication_date":"2025-11-24","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"following <span class=\"match\">items</span> and services that are eligible for outlier payments as ESRD outlier services: \n • Renal dialysis drugs and biological products that were or would have been, <span class=\"match\">prior</span> to January 1, 2011, separately billable under Medicare Part B. \n • Renal dialysis laboratory tests that were or would have been, <span class=\"match\">prior</span> to January 1, 2011, separately billable under Medicare Part B. \n • Renal dialysis medical/surgical supplies, including syringes, used to administer renal dialysis drugs and biological products that were or would have been, <span class=\"match\">prior</span> to January"},{"title":"Medicare and Medicaid Programs; Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly","type":"Proposed Rule","abstract":"This proposed rule would revise the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicaid, Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) regulations to implement changes related to Star Ratings, marketing and communications, agent/broker compensation, health equity, drug coverage, dual eligible special needs plans (D-SNPs), utilization management, network adequacy, and other programmatic areas, including the Medicare Drug Price Negotiation Program. This proposed rule also includes proposals to codify existing subregulatory guidance in the Part C and Part D programs.","document_number":"2024-27939","html_url":"https://www.federalregister.gov/documents/2024/12/10/2024-27939/medicare-and-medicaid-programs-contract-year-2026-policy-and-technical-changes-to-the-medicare","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-12-10/pdf/2024-27939.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-27939.pdf?1732656194","publication_date":"2024-12-10","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"for the annual health equity analysis of the use of <span class=\"match\">prior</span> <span class=\"match\">authorization</span> to require the metrics be reported by each <span class=\"match\">item</span> or service, rather than aggregated for all <span class=\"match\">items</span> and services. \n In the April 2024 final rule, CMS added health equity related requirements to §  422.137, including a requirement at §  422.137(d)(6) that the Utilization Management committee must conduct an annual health equity analysis of the use of <span class=\"match\">prior</span> <span class=\"match\">authorization</span>. The analysis must examine the impact of <span class=\"match\">prior</span> <span class=\"match\">authorization</span> at the plan level, on enrollees with one or more of"},{"title":"Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Ratings; and Hospital Price Transparency","type":"Proposed Rule","abstract":"This proposed rule would revise the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for calendar year 2026 based on our continuing experience with these systems. We also describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment systems. This proposed rule would also update and refine the requirements for the Hospital Outpatient Quality Reporting Program, Rural Emergency Hospital Quality Reporting Program, Ambulatory Surgical Center Quality Reporting Program, Overall Hospital Quality Star Rating, and hospitals to make public their standard charge information and enforcement of hospital price transparency. This rule also contains requests for information on measure concepts regarding Well-Being and Nutrition for consideration in future years for all three programs (OQR, REHQR, and ASCQR; expanding the method to control for unnecessary increases in the volume of covered OPD services to on- campus clinic visits; software as a service; and adjusting payment under the OPPS for services predominately performed in the ambulatory surgical center or physician office settings.","document_number":"2025-13360","html_url":"https://www.federalregister.gov/documents/2025/07/17/2025-13360/medicare-and-medicaid-programs-hospital-outpatient-prospective-payment-and-ambulatory-surgical","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-07-17/pdf/2025-13360.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-13360.pdf?1752610509","publication_date":"2025-07-17","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"},{"raw_name":"Office of the Secretary"}],"excerpts":"diagnostic services that have a global period indicator of 010 or 090.\n \n \n • Prospective Adjustment to Payments for <span class=\"match\">Non-Drug</span> <span class=\"match\">Items</span> and Services to Offset the Increased Payments for <span class=\"match\">Non-Drug</span> <span class=\"match\">Items</span> and Services Made in CY 2018 Through CY 2022 as a Result of the 340B Payment Policy. \n For CY 2026, we propose to revise the reduction to the OPPS conversion factor under § 419.32(b)(1)(iv)(B)(12) used to determine the payment amounts for <span class=\"match\">non-drug</span> <span class=\"match\">items</span> and services for hospitals for whom this adjustment applies from 0.5 percent to 2 percent. The Remedy for the"},{"title":"Medicare Program; Calendar Year (CY) 2024 Home Health (HH) Prospective Payment System Rate Update; HH Quality Reporting Program Requirements; HH Value-Based Purchasing Expanded Model Requirements; Home Intravenous Immune Globulin Items and Services; Hospice Informal Dispute Resolution and Special Focus Program Requirements, Certain Requirements for Durable Medical Equipment Prosthetics and Orthotics Supplies; and Provider and Supplier Enrollment Requirements","type":"Rule","abstract":"This final rule sets forth routine updates to the Medicare home health payment rates for calendar year (CY) 2024 in accordance with existing statutory and regulatory requirements. This rule-- discusses comments received regarding access to home health aide services; implements home health payment-related changes; rebases and revises the home health market basket and revises the labor-related share; codifies statutory requirements for disposable negative pressure wound therapy (dNPWT); and implements the new items and services payment for the home intravenous immune globulin (IVIG) benefit. In addition, it--finalizes changes to the Home Health Quality Reporting Program (HH QRP) requirements and the expanded Home Health Value-Based Purchasing (HHVBP) Model; implements the new Part B benefit for lymphedema compression treatment items, codifies the Medicare definition of brace, and makes other codification changes based on recent legislation; adds an informal dispute resolution (IDR) and special focus program (SFP) for hospice programs; codifies DMEPOS refill policy; and finalizes proposed revisions for Medicare provider and supplier enrollment requirements.","document_number":"2023-24455","html_url":"https://www.federalregister.gov/documents/2023/11/13/2023-24455/medicare-program-calendar-year-cy-2024-home-health-hh-prospective-payment-system-rate-update-hh","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-11-13/pdf/2023-24455.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-24455.pdf?1698869908","publication_date":"2023-11-13","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"following new category of medical supplies, appliances, and devices covered under Medicare Part B, Lymphedema compression <span class=\"match\">items</span> including: standard and custom fitted gradient compression garments, gradient compression wraps with adjustable straps, compression bandaging systems, and other <span class=\"match\">items</span> determined to be lymphedema compression treatment <span class=\"match\">items</span> under the process established under § 414.1670. Other covered <span class=\"match\">items</span> will <span class=\"match\">include</span> accessories such as zippers, liners, and padding or fillers that are necessary for the effective use of a gradient compression"},{"title":"Medicare and Medicaid Programs; Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly","type":"Rule","abstract":"This final rule revises the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) regulations to implement changes related to prescription drug coverage, the Medicare Prescription Payment Plan, dual eligible special needs plans (D-SNPs), Part C and D Star Ratings, and other programmatic areas, including the Medicare Drug Price Negotiation Program. This final rule also codifies existing sub-regulatory guidance in the Part C and Part D programs.","document_number":"2025-06008","html_url":"https://www.federalregister.gov/documents/2025/04/15/2025-06008/medicare-and-medicaid-programs-contract-year-2026-policy-and-technical-changes-to-the-medicare","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-04-15/pdf/2025-06008.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-06008.pdf?1743797708","publication_date":"2025-04-15","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"enrollee, has the right to request the enrollee's MA organization approve an <span class=\"match\">item</span>, service, or Part B drug in circumstances where there is a question whether the <span class=\"match\">item</span>, service, or Part B drug will be covered. This right to receive <span class=\"match\">prior</span> approval applies to services for which an MA organization may require <span class=\"match\">prior</span> <span class=\"match\">authorization</span> as a condition for coverage as well as services for which there is no <span class=\"match\">prior</span> <span class=\"match\">authorization</span> requirement. When an MA organization receives a request for an <span class=\"match\">item</span>, service, or Part B drug, it must process the request according to the timeframes"},{"title":"Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Rating; Hospital Price Transparency; and Notice of Closure of a Teaching Hospital and Opportunity To Apply for Available Slots","type":"Rule","abstract":"This final rule with comment period revises the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for calendar year 2026 based on our continuing experience with these systems. We also describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment systems. In addition, this final rule with comment period announces the closure of a teaching hospital and the opportunity to apply for available slots, and updates and refines the requirements for the Hospital Outpatient Quality Reporting Program, Rural Emergency Hospital Quality Reporting Program, Ambulatory Surgical Center Quality Reporting Program, Overall Hospital Quality Star Rating, and hospitals to make public their standard charge information and enforcement of hospital price transparency, as well as summarizes comments received in response to a request for information on measure concepts regarding Well-Being and Nutrition for consideration in future years for the OQR, REHQR, and ASCQR programs.","document_number":"2025-20907","html_url":"https://www.federalregister.gov/documents/2025/11/25/2025-20907/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-11-25/pdf/2025-20907.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-20907.pdf?1763759710","publication_date":"2025-11-25","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"},{"raw_name":"Office of the Secretary"}],"excerpts":"services that have a global period indicator of 010 or 090.\n \n \n • \n Prospective Adjustment to Payments for <span class=\"match\">Non-Drug</span> <span class=\"match\">Items</span> and Services to Offset the Increased Payments for <span class=\"match\">Non-Drug</span> <span class=\"match\">Items</span> and Services Made in CY 2018 Through CY 2022 as a Result of the 340B Payment Policy. \n For CY 2026, we are applying the previously finalized reduction to the OPPS conversion factor under § 419.32(b)(1)(iv)(B)(12) used to determine the payment amounts for <span class=\"match\">non-drug</span> <span class=\"match\">items</span> and services for hospitals for whom this adjustment applies of 0.5 percent. The Remedy for the 340B-Acquired"},{"title":"Licensing Requirements for Microreactors and Other Reactors With Comparable Risk Profiles","type":"Proposed Rule","abstract":"The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its regulations to establish a risk-informed and performance- based regulatory framework for rapid licensing of new microreactors and other reactors with comparable risk profiles and for high-volume deployment of these reactors. The proposed rule would provide a flexible set of licensing pathways, reduce regulatory burden, and ensure that safety and security requirements remain commensurate with the potential hazards posed by these facilities.","document_number":"2026-08550","html_url":"https://www.federalregister.gov/documents/2026/05/01/2026-08550/licensing-requirements-for-microreactors-and-other-reactors-with-comparable-risk-profiles","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-01/pdf/2026-08550.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-08550.pdf?1777553125","publication_date":"2026-05-01","agencies":[{"raw_name":"NUCLEAR REGULATORY COMMISSION","name":"Nuclear Regulatory Commission","id":383,"url":"https://www.federalregister.gov/agencies/nuclear-regulatory-commission","json_url":"https://www.federalregister.gov/api/v1/agencies/383","parent_id":null,"slug":"nuclear-regulatory-commission"}],"excerpts":"definition in § 50.2. The proposed definition would also <span class=\"match\">include</span> permanent removal of an individually licensed nuclear reactor. \n The proposed definition of “Defense in depth” would provide a philosophy of designing a nuclear facility that <span class=\"match\">includes</span> two or more independent and redundant layers of defense in the design of a facility and its operating procedures to compensate for uncertainties such that no single layer of defense, no matter how robust, is exclusively relied upon. Defense in depth <span class=\"match\">includes</span>, but is not limited to, the use of access controls"},{"title":"Risk-Informed, Technology-Inclusive Regulatory Framework for Advanced Reactors","type":"Rule","abstract":"The U.S. Nuclear Regulatory Commission (NRC) is amending its regulations by adding a risk-informed, performance-based, and technology-inclusive regulatory framework for commercial nuclear plants in response to the Nuclear Energy Innovation and Modernization Act (NEIMA). The current application and licensing requirements were primarily developed to address license requests concerning light water- cooled reactors and operational requirements for those types of reactors. This final rule responds to NEIMA by creating an alternative, technology-inclusive regulatory framework to accommodate licensing of future commercial nuclear plants, including advanced reactor designs that may not employ light-water technology.","document_number":"2026-06048","html_url":"https://www.federalregister.gov/documents/2026/03/30/2026-06048/risk-informed-technology-inclusive-regulatory-framework-for-advanced-reactors","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-30/pdf/2026-06048.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-06048.pdf?1774615514","publication_date":"2026-03-30","agencies":[{"raw_name":"NUCLEAR REGULATORY COMMISSION","name":"Nuclear Regulatory Commission","id":383,"url":"https://www.federalregister.gov/agencies/nuclear-regulatory-commission","json_url":"https://www.federalregister.gov/api/v1/agencies/383","parent_id":null,"slug":"nuclear-regulatory-commission"}],"excerpts":"important features and programs \n \n are in place <span class=\"match\">prior</span> to the receipt of SNM. The features and programs required to be in place <span class=\"match\">prior</span> to receipt of SNM <span class=\"match\">include</span> (1) radiation monitoring instrumentation and alarms; (2) measures to detect potential criticality accidents; (3) appropriate procedures, equipment, and personnel qualified for the fuel loading; (4) programs for physical security and cybersecurity; and (5) material control and accounting (MC&amp;A) programs. Section 53.620(d)(2)(i) <span class=\"match\">includes</span> requirements to address security programs for any"},{"title":"Medicare Program; Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly","type":"Rule","abstract":"This final rule will revise the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) regulations to implement changes related to Star Ratings, marketing and communications, health equity, provider directories, coverage criteria, prior authorization, passive enrollment, network adequacy, and other programmatic areas. This final rule will also codify regulations implementing section 118 of Division CC of the Consolidated Appropriations Act, 2021, section 11404 of the Inflation Reduction Act, and includes provisions that will codify existing sub-regulatory guidance in the Part C, Part D, and PACE programs.","document_number":"2023-07115","html_url":"https://www.federalregister.gov/documents/2023/04/12/2023-07115/medicare-program-contract-year-2024-policy-and-technical-changes-to-the-medicare-advantage-program","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-04-12/pdf/2023-07115.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-07115.pdf?1680725718","publication_date":"2023-04-12","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"},{"raw_name":"Office of the Secretary"}],"excerpts":"Criteria for Basic Benefits and Use of <span class=\"match\">Prior</span> <span class=\"match\">Authorization</span>, Additional Continuity of Care Requirements, and Annual Review of Utilization Management Tools (§§ 422.101, 422.112, 422.137, 422.138, and 422.202) \n \n In recent years, CMS has received numerous inquiries regarding MA organizations' use of <span class=\"match\">prior</span> <span class=\"match\">authorization</span> and its effect on beneficiary access to care. We are finalizing several regulatory changes to address these concerns regarding <span class=\"match\">prior</span> <span class=\"match\">authorization</span>. First, we are finalizing that <span class=\"match\">prior</span> <span class=\"match\">authorization</span> policies for coordinated care plans may"},{"title":"Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model","type":"Proposed Rule","abstract":"This proposed rule would update and revise the End-Stage Renal Disease (ESRD) Prospective Payment System for calendar year 2026. This rule also proposes to update the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. In addition, this rule proposes to update requirements for the ESRD Quality Incentive Program and to terminate and modify requirements for the ESRD Treatment Choices Model.","document_number":"2025-12368","html_url":"https://www.federalregister.gov/documents/2025/07/02/2025-12368/medicare-program-end-stage-renal-disease-prospective-payment-system-payment-for-renal-dialysis","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-07-02/pdf/2025-12368.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-12368.pdf?1751314516","publication_date":"2025-07-02","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"following <span class=\"match\">items</span> and services that are eligible for outlier payments as ESRD outlier services: \n • Renal dialysis drugs and biological products that were or would have been, <span class=\"match\">prior</span> to January 1, 2011, separately billable under Medicare Part B. \n • Renal dialysis laboratory tests that were or would have been, <span class=\"match\">prior</span> to January 1, 2011, separately billable under Medicare Part B. \n • Renal dialysis medical/surgical supplies, including syringes, used to administer renal dialysis drugs and biological products that were or would have been, <span class=\"match\">prior</span> to January"},{"title":"Medicare Program; Hospital Outpatient Prospective Payment System: Remedy for the 340B-Acquired Drug Payment Policy for Calendar Years 2018-2022","type":"Rule","abstract":"This final rule describes the agency's actions on remand from the United States (U.S.) District Court for the District of Columbia to craft a remedy in light of the U.S. Supreme Court's decision in American Hospital Association v. Becerra, 142 S. Ct. 1896 (2022), relating to the adjustment of Medicare payment rates for drugs acquired under the 340B Program from calendar year (CY) 2018 through September 27th of CY 2022.","document_number":"2023-24407","html_url":"https://www.federalregister.gov/documents/2023/11/08/2023-24407/medicare-program-hospital-outpatient-prospective-payment-system-remedy-for-the-340b-acquired-drug","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-11-08/pdf/2023-24407.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-24407.pdf?1698956389","publication_date":"2023-11-08","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"also address the <span class=\"match\">non-drug</span> <span class=\"match\">item</span> and services payment made from CY 2018 through CY 2022 as detailed in subsequent sections of this final rule. We note that because OPPS 340B drug payment is directly and inextricably linked to the OPPS payment for <span class=\"match\">non-drug</span> <span class=\"match\">items</span> and services, if the 340B drug payments are invalidated and must be remedied, then the increased payments for <span class=\"match\">non-drug</span> <span class=\"match\">items</span> and services are invalidated and must be remedied as well. But for the reductions in the 340B drug payments, the increased payments for the <span class=\"match\">non-drug</span> <span class=\"match\">items</span> and services would"},{"title":"Medicare Program; CY 2027 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System, Acute Kidney Injury Dialysis (AKI) Payment, and ESRD Quality Incentive Program","type":"Proposed Rule","abstract":"This proposed rule would update and revise the End-Stage Renal Disease (ESRD) Prospective Payment System for calendar year 2027. This rule also proposes to update the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. In addition, this rule proposes to update the requirements for the ESRD Quality Incentive Program.","document_number":"2026-12925","html_url":"https://www.federalregister.gov/documents/2026/06/26/2026-12925/medicare-program-cy-2027-changes-to-the-end-stage-renal-disease-esrd-prospective-payment-system","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-26/pdf/2026-12925.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-12925.pdf?1782332109","publication_date":"2026-06-26","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"aim to <span class=\"match\">include</span> data from two quarters <span class=\"match\">prior</span>. For example, for the third quarter post-TDAPA add-on payment adjustment, which begins July 1 of a year, we would generally <span class=\"match\">include</span> data through December of the <span class=\"match\">prior</span> year, but depending on the year December data may not be available at the time of processing. Under this proposed policy, if an update to the post-TDAPA add-on payment adjustment amount for a given quarter is not operationally feasible for some currently unforeseen reason, the post-TDAPA add-on payment adjustment amount for the <span class=\"match\">prior</span> quarter"},{"title":"Risk-Informed, Technology-Inclusive Regulatory Framework for Advanced Reactors","type":"Proposed Rule","abstract":"The U.S. Nuclear Regulatory Commission (NRC) is proposing to revise the NRC's regulations by adding a risk-informed, performance- based, and technology-inclusive regulatory framework for commercial nuclear plants in response to the Nuclear Energy Innovation and Modernization Act (NEIMA). The NRC plans to hold a public meeting to promote full understanding of the proposed rule and facilitate public comments.","document_number":"2024-23434","html_url":"https://www.federalregister.gov/documents/2024/10/31/2024-23434/risk-informed-technology-inclusive-regulatory-framework-for-advanced-reactors","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-10-31/pdf/2024-23434.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-23434.pdf?1729687518","publication_date":"2024-10-31","agencies":[{"raw_name":"NUCLEAR REGULATORY COMMISSION","name":"Nuclear Regulatory Commission","id":383,"url":"https://www.federalregister.gov/agencies/nuclear-regulatory-commission","json_url":"https://www.federalregister.gov/api/v1/agencies/383","parent_id":null,"slug":"nuclear-regulatory-commission"}],"excerpts":"admitted to using common household, <span class=\"match\">non-drug</span> substances to achieve a high or satisfy an addiction. These common household <span class=\"match\">items</span> <span class=\"match\">include</span>, but are not limited to nitrous oxide, butane, propane, glue, paint vapors, lighter fluid, nail polish remover, degreasers, permanent markers, and methyl alcohol (which is found in hand sanitizer and mouthwash).\n \n \n The definition of “\n Questionable validity \n ” would be revised to make it applicable to an FFD program implemented under subpart M of part 26, which would <span class=\"match\">include</span> all biological specimens.\n \n \n The"},{"title":"Medical Devices; Laboratory Developed Tests","type":"Rule","abstract":"The Food and Drug Administration is issuing a final rule to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. In conjunction with this amendment, the Food and Drug Administration is phasing out its general enforcement discretion approach for laboratory developed tests (LDTs) so that IVDs manufactured by a laboratory will generally fall under the same enforcement approach as other IVDs. This phaseout policy includes enforcement discretion policies for specific categories of IVDs manufactured by a laboratory, including currently marketed IVDs offered as LDTs and LDTs for unmet needs. This phaseout policy is intended to better protect the public health by helping to assure the safety and effectiveness of IVDs offered as LDTs, while also accounting for other important public health considerations such as patient access and reliance.","document_number":"2024-08935","html_url":"https://www.federalregister.gov/documents/2024/05/06/2024-08935/medical-devices-laboratory-developed-tests","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-05-06/pdf/2024-08935.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-08935.pdf?1714398256","publication_date":"2024-05-06","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"a limited number of provisions applicable to devices that <span class=\"match\">include</span> a specific interstate commerce element (88 FR 68006 at 68019-20). Where a provision applicable to devices <span class=\"match\">includes</span> an interstate commerce element, the particular interstate commerce element must be met in order for FDA to exercise authority under that provision. However, there are many provisions applicable to devices that do not <span class=\"match\">include</span> an interstate commerce element. Where a provision applicable to devices does not <span class=\"match\">include</span> an interstate commerce element, the provision applies without"},{"title":"Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Acquisition; Rural Emergency Hospitals: Payment Policies, Conditions of Participation, Provider Enrollment, Physician Self-Referral; New Service Category for Hospital Outpatient Department Prior Authorization Process; Overall Hospital Quality Star Rating; COVID-19","type":"Rule","abstract":"This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for Calendar Year (CY) 2023 based on our continuing experience with these systems. We describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. Also, this final rule updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program; the ASC Quality Reporting (ASCQR) Program; and the Rural Emergency Hospital Quality Reporting (REH) Program. We also make updates to the requirements for Organ Acquisition, REHs, Prior Authorization, and Overall Hospital Quality Star Rating. We are establishing a new provider type for REHs, and we are finalizing proposals regarding payment policy, quality measures, and enrollment policy for REHs. In addition, we are finalizing the Conditions of Participation that REHs must meet in order to participate in the Medicare and Medicaid programs. This rule also finalizes changes to the Critical Access Hospitals (CAH) CoPs for the location and distance requirements, patient's rights requirements, and flexibilities for CAHs that are part of a larger health system. Finally, we are finalizing as implemented a number of provisions included in the COVID-19 interim final rules with comment period (IFCs).","document_number":"2022-23918","html_url":"https://www.federalregister.gov/documents/2022/11/23/2022-23918/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-11-23/pdf/2022-23918.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-23918.pdf?1667506528","publication_date":"2022-11-23","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"exceptions, <span class=\"match\">items</span> and services within an APC group cannot be considered comparable with respect to the use of resources if the highest median cost (or mean cost, if elected by the Secretary) for an <span class=\"match\">item</span> or service in the APC group is more than 2 times greater than the lowest median cost (or mean cost, if elected by the Secretary) for an <span class=\"match\">item</span> or service within the same APC group (referred to as the “2 times rule”). In implementing this provision, we generally use the cost of the <span class=\"match\">item</span> or service assigned to an APC group. \n For new technology <span class=\"match\">items</span> and services"},{"title":"Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program","type":"Proposed Rule","abstract":"This major proposed rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; codification of establishment of new policies for: the Medicare Prescription Drug Inflation Rebate Program under the Inflation Reduction Act of 2022; the Ambulatory Specialty Model; updates to the Medicare Diabetes Prevention Program expanded model; updates to drugs and biological products paid under Part B; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; updates to policies for Rural Health Clinics and Federally Qualified Health Centers update to the Ambulance Fee Schedule regulations; codification of the Inflation Reduction Act and Consolidated Appropriations Act, 2023 provisions; updates to the Medicare Promoting Interoperability Program.","document_number":"2025-13271","html_url":"https://www.federalregister.gov/documents/2025/07/16/2025-13271/medicare-and-medicaid-programs-cy-2026-payment-policies-under-the-physician-fee-schedule-and-other","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-07-16/pdf/2025-13271.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-13271.pdf?1752524111","publication_date":"2025-07-16","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"recommended <span class=\"match\">item</span> due to inadequate information. Sometimes, no supporting information regarding the price of the <span class=\"match\">item</span> has been included in the recommendation. In other cases, the supporting information does not demonstrate that the <span class=\"match\">item</span> has been purchased at the listed price (for example, vendor price quotes instead of paid invoices). In cases where the information provided on the <span class=\"match\">item</span> allows us to identify clinically appropriate proxy <span class=\"match\">items</span>, we might use existing <span class=\"match\">items</span> as proxies for the newly recommended <span class=\"match\">items</span>. In other cases, we <span class=\"match\">include</span> the <span class=\"match\">item</span> in the"},{"title":"Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program","type":"Rule","abstract":"This major final rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; codification of establishment of new policies for: the Medicare Prescription Drug Inflation Rebate Program under the Inflation Reduction Act of 2022; the Ambulatory Specialty Model; updates to the Medicare Diabetes Prevention Program expanded model; updates to drugs and biological products paid under Part B; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; updates to policies for Rural Health Clinics and Federally Qualified Health Centers; update to the Ambulance Fee Schedule regulations; codification of the Inflation Reduction Act and Consolidated Appropriations Act, 2023 provisions; updates to the Medicare Promoting Interoperability Program.","document_number":"2025-19787","html_url":"https://www.federalregister.gov/documents/2025/11/05/2025-19787/medicare-and-medicaid-programs-cy-2026-payment-policies-under-the-physician-fee-schedule-and-other","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-11-05/pdf/2025-19787.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-19787.pdf?1761945018","publication_date":"2025-11-05","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"recommended <span class=\"match\">item</span> due to inadequate information. Sometimes, no supporting information regarding the price of the <span class=\"match\">item</span> has been included in the recommendation. In other cases, the supporting information does not demonstrate that the <span class=\"match\">item</span> has been purchased at the listed price (for example, vendor price quotes instead of paid invoices). In cases where the information provided on the <span class=\"match\">item</span> allows us to identify clinically appropriate proxy <span class=\"match\">items</span>, we may use existing <span class=\"match\">items</span> as proxies for the newly recommended <span class=\"match\">items</span>. In other cases, we <span class=\"match\">include</span> the <span class=\"match\">item</span> in the"}]}