On February 21, 2025, the Centers for Medicare & Medicaid Services (CMS) announced public engagement events for the second cycle of the Medicare Drug Price Negotiation Program.

On February 20, 2025, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) rescinded prior guidance on gender-affirming care, entitled “HHS Notice and Guidance on Gender Affirming Care, Civil Rights, and Patient Privacy,” issued March 2, 2022 (2022 Guidance).

On January 17, 2025, the Centers for Medicare & Medicaid Services (CMS) issued the list of 15 additional Part D drugs for the Medicare Drug Price Negotiation Program.

In January 2025, the U.S. Department of Health and Human Services (HHS) issued a Strategic Plan for the Use of Artificial Intelligence in Health, Human Services, and Public Health in efforts to use AI responsibly to improve people's lives.

On December 20, 2024, the Centers for Medicare & Medicaid Services (CMS) issued explanations for the maximum fair prices (MFPs) for the drugs selected for the IRA’s Medicare Drug Price Negotiation Program for the initial price applicability year (IPAY) 2026.

On Dec. 12, 2024, the Centers for Medicare and Medicaid Services (CMS) issued a final rule titled, “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” (Final Rule).

On December 4, 2024, the Centers for Medicare and Medicaid Services (CMS) announced that two drug manufacturers of gene therapies for sickle cell disease have entered into agreements to participate in the Cell and Gene Therapy Access Model (CGT Access Model).

On November 15, 2024, the Centers for Medicare & Medicaid Services (CMS) issued an update to the set of frequently asked questions (FAQs) related to the Medicare Prescription Payment Plan originally issued on October 1, 2024.

On November 1, 2024, the Centers for Medicare and Medicaid Services (CMS) issued the Physician Fee Schedule Final Rule (Final Rule), which is scheduled to be published in the Federal Register on December 9, 2024. In addition to finalizing payment rates, the Final Rule includes a variety of provisions that may impact managed care pharmacy.

On October 2, 2024, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) issued the Final Guidance for the Second Cycle of the Historic Medicare Drug Price Negotiation Program for Fiscal Year 2027.

On Oct. 1, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a set of frequently asked questions (FAQs) related to the Medicare Prescription Payment Plan.

On September 30, 2024, the Centers for Medicare and Medicaid Services (CMS) issued a Decision Memo titled “Final National Coverage Determination (NCD) for Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Prevention”