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Rural Health Information Hub
Rural Health Information Hub

Rural Health
News by Topic: Pharmacy and prescription drugs

Jul 15, 2025 - Pre-publication 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 within 60 days of the publication of this notice.
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
May 29, 2025 - Notice from the Centers for Medicare & Medicaid Services (CMS) making technical corrections to the April 15, 2025, final rule. These corrections are effective May 29, 2025.
Source: Federal Register
May 29, 2025 - The Food and Drug Administration (FDA) has revoked 6 Emergency Use Authorizations issued to Pfizer Inc., MAWD Laboratories, and Nuclein, LLC (merged with Molecular Diagnostics Inc.) related to COVID-19 detection and diagnosis tests.
Source: Federal Register
May 28, 2025 - The Centers for Medicare & Medicaid Services is seeking comments on the following information collections: 1) Application for Part B Immunosuppressive Drug Coverage (Part B-ID); 2) Data Use Agreement (DUA) Limited Data Set (LDS) Forms Research Identifiable Files (RIF) Forms; 3) Comprehensive Outpatient Rehabilitation Facility (CORF) Certification and Survey Forms; and 4) Rural Community Hospital Demonstration Program Application. Comments are due by June 27, 2025.
Source: Federal Register
May 21, 2025 - The Centers for Medicare & Medicaid Services (CMS) is seeking comments on the following information collections: 1) Medicare Part C and Part D Data Validation; 2) Appointment of Representative; 3) Essential Health Benefits in Alternative Benefit Plans, Eligibility Notices, Fair Hearing and Appeal Processes, and Premiums and Cost Sharing; Exchanges: Eligibility and Enrollment; and 4) Affordable Care Act Internal Claims and Appeals and External Review Procedures for Non-grandfathered Group Health Plans and Issuers and Individual Market Issuers. Comments are due by July 21, 2025.
Source: Federal Register
May 21, 2025 - The Food and Drug Administration has revoked Emergency Use Authorizations issued to Fresenius Medical Care North America (Fresenius) multiFiltrate PRO System and multiBic/multiPlus solutions (EUA 048) and to Baxter Healthcare Corp. (Baxter) for REGIOCIT (EUA 068). These revocations are effective January 16, 2025.
Source: Federal Register
May 16, 2025 - Notice from the Centers for Medicare & Medicaid Services (CMS) making technical and typographic corrections to the December 9, 2024, final rule and the December 30, 2024, correcting amendment. The corrections and correcting amendment are effective May 16, 2025, and applicable beginning January 1, 2025.
Source: Federal Register