Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs, Including the Hospital Inpatient Quality Reporting Program; Health and Safety Standards for Obstetrical Services in Hospitals and Critical Access Hospitals; Prior Authorization; Requests for Information; Medicaid and CHIP Continuous Eligibility; Medicaid Clinic Services Four Walls Exceptions; Individuals Currently or Formerly in Custody of Penal Authorities; Revision to Medicare Special Enrollment Period for Formerly Incarcerated Individuals; and All-Inclusive Rate Add-On Payment for High-Cost Drugs Provided by Indian Health Service and Tribal Facilities

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Centers for Medicare & Medicaid Services</SUBAGY> <CFR>42 CFR Parts 406, 407, 410, 411, 416, 419, 435, 440, 457, 482, and 485</CFR> <DEPDOC>[CMS-1809-FC]</DEPDOC> <RIN>RIN 0938-AV35</RIN> <SUBJECT>Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs, Including the Hospital Inpatient Quality Reporting Program; Health and Safety Standards for Obstetrical Services in Hospitals and Critical Access Hospitals; Prior Authorization; Requests for Information; Medicaid and CHIP Continuous Eligibility; Medicaid Clinic Services Four Walls Exceptions; Individuals Currently or Formerly in Custody of Penal Authorities; Revision to Medicare Special Enrollment Period for Formerly Incarcerated Individuals; and All-Inclusive Rate Add-On Payment for High-Cost Drugs Provided by Indian Health Service and Tribal Facilities</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS). <HD SOURCE="HED">ACTION:</HD> Final rule with comment period. <SUM> <HD SOURCE="HED">SUMMARY:</HD> 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 2025 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 the requirements for the Hospital Outpatient Quality Reporting Program, Rural Emergency Hospital Quality Reporting Program, Ambulatory Surgical Center Quality Reporting Program, and Hospital Inpatient Quality Reporting Program. We also summarize information received in response to a Request for Information on potential modifications to the Safety of Care measure group in the Overall Hospital Quality Star Rating methodology. In this final rule, we are also finalizing our proposal to narrow the description of “custody” in the Medicare payment exclusion rule and to revise the special enrollment period criteria for formerly incarcerated individuals. We are also finalizing our Medicaid and Children's Health Insurance Program (CHIP) continuous eligibility provisions. We are also finalizing the proposal to reduce the review timeframe for standard prior authorization requests for certain covered outpatient department services paid under the OPPS from 10-business days to 7-calendar days. Further, this rule finalizes updates to the Conditions of Participation (CoPs) for hospitals and critical access hospitals (CAHs) in an effort to advance the health and safety of pregnant, birthing, and postpartum women. This rule also finalizes our proposed policy to separately pay Indian Health Service (IHS) and Tribal hospitals for high-cost drugs furnished in hospital outpatient departments through an add-on payment in addition to the all-inclusive rate (AIR) under the authorities used to calculate the AIR starting January 1, 2025. Finally, we are finalizing exceptions to the Medicaid clinic services four walls requirement for IHS and Tribal clinics, and, at state option, for behavioral health clinics and clinics located in rural areas. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> <E T="03">Effective date:</E> The provisions of this rule are effective January 1, 2025. <E T="03">Implementation date:</E> Except as set forth in this section, the regulations at §§ 482.43(c), 482.55(c), and 485.618(e) must be implemented by July 1, 2025; the regulations at §§ 482.59(a) and (b) and 485.649(a) and (b) must be implemented by January 1, 2026; and the regulations at §§ 482.21(b)(4) and (e), 482.59(c), 485.641(d)(4) and (e)(2), and 485.649(c) must be implemented by January 1, 2027. <E T="03">Comment period:</E> To be assured consideration, comments must be received at one of the addresses provided below, by December 31, 2024. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> In commenting, please refer to file code CMS-1809-FC. Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed): 1. <E T="03">Electronically.</E> You may submit electronic comments on this regulation to <E T="03">https://www.regulations.gov</E> . Follow the “Submit a comment” instructions. 2. <E T="03">By regular mail.</E> You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1809-FC, P.O. Box 8010, Baltimore, MD 21244-8010. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. <E T="03">By express or overnight mail.</E> You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1809-FC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. For information on viewing public comments, see the beginning of the <E T="02">SUPPLEMENTARY INFORMATION</E> section. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Regulation coordination questions at <E T="03">OPPS-ASC-Rulemaking@cms.hhs.gov</E> or Elise Barringer (410) 786, 9222. Advisory Panel on Hospital Outpatient Payment (HOP Panel), contact the HOP Panel mailbox at <E T="03">APCPanel@cms.hhs.gov</E> . Ambulatory Surgical Center Quality Reporting (ASCQR) Program policies, contact Anita Bhatia via email at <E T="03">Anita.Bhatia@cms.hhs.gov</E> . Ambulatory Surgical Center Quality Reporting (ASCQR) Program measures, contact Marsha Hertzberg via email at <E T="03">Marsha.Hertzberg@cms.hhs.gov</E> . All-Inclusive Rate (AIR) Add-On Payment for High-Cost Drugs Provided by Indian Health Service (IHS) and Tribal Facilities, contact Nate Vercauteren via email at <E T="03">Nathan.Vercauteren@cms.hhs.gov</E> . Blood and Blood Products, contact Au'Sha Washington via email at <E T="03">AuShaWashington@cms.hhs.gov</E> or Nicole Marcos via email at <E T="03">Nicole.Marcos@cms.hhs.gov</E> . Cancer Hospital Payments, contact Scott Talaga via email at <E T="03">Scott.Talaga@cms.hhs.gov</E> . CMS Web Posting of the OPPS and ASC Payment Files, contact Gil Ngan via email at <E T="03">Gil.Ngan@cms.hhs.gov</E> . Medicaid Clinic Services Four Walls Exceptions, contact Sheri Gaskins via email at <E T="03">Sheri.Gaskins@cms.hhs.gov</E> or Ryan Tisdale via email at <E T="03">Ryan.Tisdale@cms.hhs.gov</E> . Composite APCs (Multiple Imaging and Mental Health) and Comprehensive APCs (C-APCs), via email at Elise Barringer via email at <E T="03">Elise.Barringer@cms.hhs.gov</E> . Device-Intensive Status and No Cost/Full Credit and Partial Credit Devices, contact Scott Talaga via email at <E T="03">Scott.Talaga@cms.hhs.gov</E> . Domestic Personal Protection Equipment RFI, contact Jesse Hawkins via email at <E T="03">jesse.hawkins@hhs.gov</E> Health and Safety Standards for Obstetrical Services in Hospitals and Critical Access Hospitals, contact The Clinical Standards Group, <E T="03">HealthandSafetyInquiries@cms.hhs.gov</E> Hospital Inpatient Quality Reporting (IQR) Program policies, contact Julia Venanzi via email at <E T="03">julia.venanzi@cms.hhs.gov</E> . Hospital Inpatient Quality Reporting (IQR) Program measures, contact Melissa Hager via email at <E T="03">melissa.hager@cms.hhs.gov</E> or Ngozi Uzokwe via email at <E T="03">ngozi.uzokwe@cms.hhs.gov</E> . Hospital Outpatient Quality Reporting (OQR) Program policies, contact Kimberly Go via email at <E T="03">Kimberly.Go@cms.hhs.gov</E> . Hospital Outpatient Quality Reporting (OQR) Program measures, contact Janis Grady via email at <E T="03">Janis.Grady@cms.hhs.gov</E> . Hospital Outpatient Visits (Emergency Department Visits and Critical Care Visits), contact Elise Barringer via email at <E T="03">Elise.Barringer@cms.hhs.gov</E> . IHS Outpatient Encounter Rate available to all American Indian and Alaska Native (AI/AN) Outpatient Programs Request for Information, contact Lisa Parker via email at <E T="03">Lisa.Parker1@cms.hhs.gov</E> . Inpatient Only (IPO) Procedures List, contact Abigail Cesnik via email at <E T="03">Abigail.Cesnik@cms.hhs.gov</E> . Medicaid and CHIP Continuous Eligibility Policy, contact Cassie Lagorio via email at <E T="03">Cassandra.Lagorio@cms.hhs.gov</E> . New Technology Intraocular Lenses (NTIOLs), contact Scott Talaga via email at <E T="03">Scott.Talaga@cms.hhs.gov</E> . No Legal Obligation to Pay Payment Exclusion, contact Frederick Grabau via email at <E T="03">Frederick.Grabau@cms.hhs.gov</E> . Non-Opioid Policy or Implementation of Section 4135 of the Consolidated Appropriations Act (CAA), 2023, contact Cory Duke via email at <E T="03">Cory.Duke@cms.hhs.gov</E> . OPPS Brachytherapy, contact Cory Duke via email at <E T="03">Cory.Duke@cms.hhs.gov</E> and Scott Talaga via email at <E T="03">Scott.Talaga@cms.hhs.gov</E> . OPPS Data (APC Weights, Conversion Factor, Copayments, Cost-to-Charge Ratios (CCRs), Data Claims, Geometric Mean Calculation, Outlier Payments, and Wage Index), contact Erick Chuang via email at <E T="03">Erick.Chuang@cms.hhs.gov</E> or Scott Talaga via email at <E T="03">Scott.Talaga@cms.hhs.gov</E> . OPPS Dental Policy, contact Nicole Marcos via email at <E T="03">Nicole.Marcos@cms.hhs.gov</E> . OPPS Drugs, Radiopharmaceuticals, Biologicals, and Biosimilar Products, contact Gil Ngan via email at <E T="03">Gil.Ngan@cms.hhs.gov</E> , Cory Duke via ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 3644k characters. 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