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On September 30, 2025, the Centers for Medicare and Medicaid Services (CMS) issued final guidance for the third cycle of the Medicare Drug Price Negotiation Program for Initial Price Applicability Year (IPAY) 2028. Negotiations for the Maximum Fair Prices (MFP) on up to 15 additional negotiation-eligible Part D and/or Part B drugs will occur in 2026, with the MFP effective in IPAY 2028.
On September 30, 2025, the White House announced a deal with Pfizer to lower drug costs in line with most-favored nation (MFN) pricing. While specific terms of the agreement have not been disclosed, both Pfizer and the White House issued statements providing a broad outline of the agreement.
On September 22, 2025, President Trump claimed that acetaminophen, the active ingredient in Tylenol, taken during pregnancy increases the risk of autism. Acetaminophen has long been considered one of the few safe options for treating pain or fever during pregnancy.
On Sept 18 and Sept 19, 2025, the Advisory Committee on Immunization Practices (ACIP) met to review data and vote on vaccine recommendations.
On September 9, 2025, the Make America Healthy Again Commission (MAHA Commission) issued a strategy report titled, Make our Children Health Again (MOCHA Strategy Report).
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.
