Rural Health
News by Topic: Legislation and regulations
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
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 25, 2025 - Highlights the Rural Health Transformation Program, part of
the One Big Beautiful Bill Act.
Source: The White House
Jul 23, 2025 - Announcement from the Centers for Medicare & Medicaid Services (CMS) of receipt of an application for continued recognition of the Accreditation Commission for Health Care as a national accrediting organization for Critical Access Hospitals that wish to participate in the Medicare or Medicaid programs. Comments are due by August 22, 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