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On August 20, 2025, the U.S. Department of Health and Human Services (HHS) issued updates (the Interim Final Rule) which amends the final rule titled “Administrative Simplification: Modifications of Health Insurance Portability and Accountability Act of 1996 (HIPAA) National Council for Prescription Drug Programs (NCPDP) Retail Pharmacy Standards; and Modification of the Medicaid Pharmacy Subrogation Standard,” (the December 2024 Final Rule).
On July 3, 2025, CMS announced new opioid safety edit submission guidelines for Medicare Part D sponsors for 2026.
The Centers for Medicare and Medicaid Services (CMS) finalized a rule on Marketplace Integrity and Affordability. The Final Rule has not yet been published in the Federal Register but will take effect 60 days after such publication.
On May 22, 2025, the President’s Make America Healthy Again Commission published the MAHA report. The report raises concerns about the chronic childhood disease, processed food, environmental chemicals, lack of physical activity, mental health, and overmedicalization of American children.
On May 12, 2025, President Trump signed an Executive Order (EO) requiring agencies to take steps to encourage manufacturers to provide most-favored-nation pricing for prescription drugs.
On April 16, 2025, the Centers for Medicare and Medicaid Services (CMS) issued guidance on CY 2026 Part D Formulary Submissions (Guidance). The Guidance includes important dates related to CY 2026 formulary submissions.
On April 15, 2025, the Trump administration issued an Executive Order (EO) on prescription drug costs.
On April 7, 2025, the Centers for Medicare and Medicaid Services issued the Calendar Year (CY) 2026 Rate Announcement and Final CY 2026 Part D Redesign Program Instructions.
On April 4, 2025, the Centers for Medicare & Medicaid Services (CMS) released the Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (Part D Final Rule).
On March 27, 2025, the U.S. Department of Health and Human Services (HHS) issued a Fact Sheet: HHS’ Transformation to Make America Healthy Again. The document outlines HHS' restructuring plan as part of an initiative to enhance efficiency and address chronic diseases in America. Key changes include significant personnel reductions and consolidating divisions and offices to streamline operations.
On March 12, 2025, the Centers for Medicare & Medicaid Services (CMS) Innovation Center announced the early termination of several payment model trials by December 31, 2025.
On February 28, 2025, the Department of Health and Human Services (HHS) issued a Policy on Adhering to the Text of the Administrative Procedure Act (Policy Statement) rescinding a longstanding policy where HHS agencies used full “notice and comment” procedures beyond the minimum circumstances required by the Administrative Procedure Act (APA).
