Rural Health
News by Topic: Healthcare needs and services
HRSA: 340B Program Notice: Application Process for the 340B Rebate Model Pilot Program
Federal Register
Aug 1, 2025 - Announcement of the application process for the 340B Rebate Model Pilot Program and call for comments related to the structure and application process of the program. This program is voluntary and aims to test a rebate model on a select group of drugs for the purpose of understanding the merits and shortcomings of the rebate model. Drug manufacturers interested in participating should email 340BPricing@hrsa.gov by September 15, 2025. The program will start January 1, 2026 and run for 1 year. Comments are due September 2, 2025.
Source: Federal Register
Aug 1, 2025 - Pre-publication notice of final rule from the Centers revising the hospital inpatient prospective payment system (IPPS) for operating and capital-related costs of acute care hospitals for fiscal year 2026. This rule also makes changes related to Medicare graduate medical education (GME) for teaching hospitals; updates payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals; updates and make changes to requirements for certain quality programs; and finalizes certain updates to the ONC Health Information Technology (IT) Certification Program among other things. These final rules are effective October 1, 2025.
Source: Federal Register
Aug 1, 2025 - Pre-publication notice of final rule from the Centers for Medicare & Medicaid Services (CMS) updating the skilled nursing facility (SNF) prospective payment system (PPS) payment rates for fiscal year 2026. Among other things, this rule updates the requirements for the SNF Quality Reporting Program and the SNF Value-Based Purchasing Program. These regulations are effective October 1, 2025.
Source: Federal Register
SAMHSA: Agency Information Collection Activities: Submission for OMB Review; Comment Request
Federal Register
Aug 1, 2025 - The Substance Abuse and Mental Health Services Administration is seeking comments on a proposed evaluation of the 988 Suicide and Crisis Lifeline and Crisis Services program with a specific look at the impact of the program on suicide and overdose morbidity and mortality. Comments are due within 30 days of publication.
Source: Federal Register
FDA: Revocation of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability
Federal Register
Jul 29, 2025 - The Food and Drug Administration (FDA) has revoked Emergency Use Authorizations issued to Regeneron Pharmaceuticals, Inc., for REGEN-COV (casirivimab and imdevimab administered together); GlaxoSmithKline LLC for sotrovimab; Eli Lilly and Company for bebtelovimab; and AstraZeneca Pharmaceuticals LP for EVUSHELD (tixagevimab co-packaged with cilgavimab). These revocations are effective December 13, 2024.
Source: Federal Register
CMS: Agency Information Collection Activities: Submission for OMB Review; Comment Request
Federal Register
Jul 28, 2025 - The Centers for Medicare and Medicaid Services is seeking comments on the following information collections: 1) Medicare Geographic Classification Review Board Procedures and Criteria; 2) Part C and Part D Medicare Prescription Payment Plan Model Documents; and 3) Applicable Integrated Plan Coverage Decision Letter. Comments are due by August 27, 2025.
Source: Federal Register
DOD: TRICARE Coverage of Clinical Trials and Termination of Expanded Access Treatments
Federal Register
Jul 28, 2025 - Notice of final rule from the Department of Defense (DOD) Defense Health Agency (DHA) finalizing provisions published in two interim final rules (IFRs) that temporarily added coverage for the treatment use of investigational drugs under U.S. Food and Drug Administration (FDA)-authorized expanded access (EA) programs when for the treatment of coronavirus disease 2019 (COVID-19) and permitted coverage of National Institute of Allergy and Infectious Disease (NIAID)-sponsored clinical trials for the treatment or prevention of COVID-19. Among other things, this rule discusses the DOD's decision not to make permanent the coverage of treatment use of investigational drugs under FDA EA programs while updating language for care associated with their administration and broadens the COVID-19 clinical trial benefit to include coverage of clinical trials sponsored or approved by any National Institutes of Health (NIH) Center or Institute to treat or prevent infectious diseases associated with a pandemic or epidemic. This rule is effective August 27, 2025.
Source: Federal Register
Jul 22, 2025 - Notice of proposed rule from the Department of Veterans Affairs proposing revisions to its medical regulations to add a new method of notification for emergency treatment furnished by community providers to be authorized under the Veterans Community Care Program (VCCP). Among other things, this rule proposes to amend the requirement that a notice of emergency treatment authorized under the VCCP be provided to the appropriate VA official at the nearest VA facility within 72 hours of treatment by adding that notice can also be provided through the centralized notification process. Comments are due by September 22, 2025.
Source: Federal Register
CMS: Agency Information Collection Activities: Submission for OMB Review; Comment Request
Federal Register
Jul 21, 2025 - The Centers for Medicare & Medicaid Services (CMS) is seeking comments on the reinstatement of an information collection titled "Medicare and Medicaid Programs: Home Health Facilities (HHAs) and Supporting Regulations." The information collected is used to ensure that home health agencies comply with the Conditions of Participation. Comments are due by August 20, 2025.
Source: Federal Register
Jul 17, 2025 - Notice of a proposed rule from the Centers
for Medicare & Medicaid Services (CMS) making changes to
the Medicare Hospital Outpatient Prospective Payment System
(OPPS) and the Medicare Ambulatory Surgical Center (ASC)
payment system for calendar year 2026, including 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. Among other updates, this
rule also proposes updates related to 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. Comments are due September 15, 2025.
Source: Federal Register