Rural Health
News by Topic: Pharmacy and prescription drugs
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
FDA: Revocation of Four Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
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
CMS: Agency Information Collection Activities: Submission for OMB Review; Comment Request
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
CMS: Agency Information Collection Activities: Proposed Collection; Comment Request
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
FDA: Revocation of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability
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
CMS: Agency Information Collection Activities: Proposed Collection; Comment Request
Federal Register
May 13, 2025 - The Centers for Medicare & Medicaid Services (CMS) is seeking comments on the following information collections: 1) Medicare Geographic Classification Review Board Procedures and Criteria and 2) Part C and Part D Medicare Prescription Payment Plan Model Documents. Comments are due by July 14, 2025.
Source: Federal Register
CMS: Agency Information Collection Activities: Submission for OMB Review; Comment Request
Federal Register
May 12, 2025 - The Centers for Medicare & Medicaid Services is seeking comments on the following information collections: 1) Laboratory Personnel Report (CLIA) and Supporting Regulations; 2) End Stage Renal Disease (ESRD) Conditions for Coverage and Supporting Regulations; 3) Hospice Information for Medicare Part D Plans; 4) Part D Coordination of Benefits Data; and 5) Requirements Related to Surprise Billing: Qualifying Payment Amount, Notice and Consent, Disclosure on Patient Protections Against Balance Billing, and State Law Opt-in. Comments are due by June 11, 2025.
Source: Federal Register
Apr 15, 2025 - Notice of final rule from the Centers for Medicare & Medicaid Services (CMS) revising the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) regulations to implement changes related to prescription drug coverage, the Medicare Prescription Payment Plan, dual eligible special needs plans (D-SNPs), Part C and Part D Star Ratings, and other programmatic areas, including the Medicare Drug Price Negotiation Program. This final rule also codifies existing sub-regulatory guidance in the Part C and Part D programs. These regulations are effective June 3, 2025.
Source: Federal Register