Tag: Health and Human Services Department

  • Calendar Year 2027 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the Expanded HH Value-Based Purchasing Model; Medicare Provider Enrollment, Durable Medical Equipment (DME), and DME

    This final rule sets forth routine updates to the Medicare home health payment rates in accordance with existing statutory and regulatory requirements. In addition, this final rule discusses the behavior adjustments and finalizes a temporary behavior adjustment. It also finalizes the recalibrated case-mix weights and updated functional impairment levels; comorbidity subgroups; and low-utilization payment adjustment (LUPA) thresholds for CY 2027. Additionally, this final rule discusses and responds to comments on the provision of home health palliative care services and includes a summary of comments received on the request for information (RFI) on a home health specific wage index included in the proposed rule. This rule also finalizes changes to the Home Health Quality Reporting Program (HH QRP) and summarizes potential initiatives to improve alignment between the HH QRP and expanded Home Health Value- Based Purchasing (HHVBP) Model. Lastly, the rule clarifies the application of the DMEPOS face-to- face encounter requirements for the replacement of DMEPOS items; makes changes to the provider and supplier enrollment requirements; makes changes to implement a DME benefit expansion for infusion pumps and drugs; and discusses collection of information requirement changes regarding the DMEPOS Competitive Bidding Program (CBP) country of origin.

    • Agencies: Health and Human Services Department, Centers for Medicare & Medicaid Services
    • Document type: Rule
    • Document number: 2026-22750

    Source: Federal Register — Cybersecurity · 2026-11-08

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  • Medicare and Medicaid Programs; CY 2027 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

    This 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; limiting Medicare coverage of certain individuals; the Ambulatory Specialty 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, 2026 provisions; updates to Clinical Laboratory Fee Schedule regulations; updates to the Medicare Promoting Interoperability Program.

    • Agencies: Health and Human Services Department, Centers for Medicare & Medicaid Services
    • Document type: Rule
    • Document number: 2026-22743

    Source: Federal Register — Cybersecurity · 2026-11-08

  • 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; Requ

    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 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 final rule with comment period updates and refines 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 finalized the expansion of the prior authorization requirement to include additional Botulinum Toxin Injection services. We also finalized implementation of certain provisions of the Consolidated Appropriations Act, 2026, for off-campus outpatient departments of a provider. In addition, this final rule with comment period announces notices of closure of teaching hospitals and opportunities to apply for available slots. Additionally, we finalized the policy that hospital accrediting organizations (AOs) with deeming authority may assess compliance with certain Emergency Medical Treatment and Labor Act (EMTALA) administrative requirements under 42 CFR 489.20 during accreditation and reaccreditation surveys.

    • Agencies: Health and Human Services Department, Centers for Medicare & Medicaid Services
    • Document type: Rule
    • Document number: 2026-22739

    Source: Federal Register — Cybersecurity · 2026-11-06

  • Medical Devices; Hematology and Pathology Devices; Classification of the Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm

    The Food and Drug Administration (FDA) is classifying the digital cervical cytology slide imaging system with artificial intelligence algorithm into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the digital cervical cytology slide imaging system with artificial intelligence algorithm. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.

    • Agencies: Health and Human Services Department, Food and Drug Administration
    • Document type: Rule
    • Document number: 2026-22593

    Source: Federal Register — Cybersecurity · 2026-11-05

    Documents