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Rural Health Information Hub
Rural Health Information Hub

Rural Health
News by Topic: Pharmacy and prescription drugs

Aug 7, 2025 - Notice from the Health Resources and Services Administration (HRSA) correcting the August 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. Drug manufacturer plans for participation in the 340B Rebate Model Pilot Program should be submitted 340BPricing@hrsa.gov by September 15, 2025. The program will start January 1, 2026, and run for 1 year. Comments are due September 8, 2025.
Source: Federal Register
Aug 7, 2025 - Notice from the Health Resources and Services Administration (HRSA) seeking comments on an information collection request titled "Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program, OMB No. 0915-0327—Revision." HRSA requires covered entities to submit administrative information, certifying information, and attestation from appropriate grantee-level or entity-level authorizing officials and primary contacts in order to enroll and certify the eligibility of federally funded grantees and other safety net health care providers. Comments are due by October 6, 2025.
Source: 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
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
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
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 15, 2025 - Notice of a proposed rule from the Centers for Medicare & Medicaid Services (CMS) addressing: 1) changes to the Physician Fee Schedule and Medicare Part B payment policies; 2) policies for the Medicare Prescription Drug Inflation Rebate Program under the Inflation Reduction Act of 2022; 3) the Ambulatory Specialty Model; 4) updates to the Medicare Diabetes Prevention Program expanded model; 5) updates to drugs and biological products paid under Part B; 6) Medicare Shared Savings Program requirements; 7) updates to the Quality Payment Program; 8) updates to policies for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs); 9) updates to the Ambulance Fee Schedule regulations; 10) codification of the Inflation Reduction Act and Consolidated Appropriations Act, 2023 provisions; and 11) updates to the Medicare Promoting Interoperability Program. Comments are due on September 12, 2025.
Source: Federal Register
Jul 14, 2025 - The Centers for Medicare and Medicaid Services is seeking comments on the following information collections: 1) The PACE Organization (PO) Monitoring and Audit Process; and 2) Creditable Coverage Disclosure to CMS On-Line Form and Instructions. Comments are due by August 13, 2025.
Source: Federal Register
Jun 27, 2025 - The Centers for Medicare & Medicaid Services is seeking comment on the following information collections: 1) Medicare Self-Referral Disclosure Protocol; 2) Health Insurance Portability and Accountability Act (HIPAA) Administrative Simplification (Non-Privacy/Security) Complaint Form; and 3) Drug Price Negotiation for Initial Price Applicability Year 2028 under Sections 11001 and 11002 of the Inflation Reduction Act Information Collection Request (ICR). Comments are due by August 26, 2025.
Source: Federal Register
Jun 24, 2025 - Announces new requirements for HRSA-funded health centers to provide insulin and injectable epinephrine to low-income patients at or below the price paid by health centers through the 340B Drug Pricing Program.
Source: Health Resources & Services Administration