• On April 6, 2026, the Centers for Medicare and Medicaid Services (CMS) issued the Calendar Year (CY) 2027 Medicare Advantage (MA) and Part D Rate Announcement (Rate Announcement).

On April 2, 2026, the Centers for Medicare and Medicaid Services (CMS) issued the Contract Year 2027 and Certain Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program Final Rule. 

On February 23, 2026, the U.S. Food and Drug Administration (FDA) released draft guidance outlining a new regulatory framework to support approval of individualized therapies for ultra-rare diseases when randomized controlled trials are infeasible because of extremely small patient populations.

On January 27, 2026, the Centers for Medicare and Medicaid Services (CMS) announced the list of drugs selected for the third round of the Medicare Drug Price Negotiation Program.

On January 23, 2026, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) issued three notices: Rescission of Guidance to Nation’s Retail Pharmacies: Obligations under Federal Civil Rights Laws to Ensure Nondiscriminatory Access to Health Care at Pharmacies (Pharmacy Notice), Rescission of Guidance on Nondiscrimination Protections under the Church Amendments (Nondiscrimination Notice), and Rescission of Office for Civil Rights Documents under Executive Order 14192 (Additional Documents Notice).

On January 15, 2026, the White House released its Great Healthcare Plan (the Plan) as a broad framework for congressional action on lowering drug prices, lowering insurance premiums, and increasing price transparency. The Plan outlines several policy ideas for Congress to consider.

On January 5, 2026, the Centers for Disease Control and Prevention (CDC) revised the childhood and adolescent immunization schedule.

On December 9, 2025, the Food and Drug Administration (FDA) released final guidance on promotional labeling and advertising for prescription biological reference products, biosimilar products, and interchangeable biosimilar products (Final Guidance). 

On December 4 and 5, 2025, the Advisory Committee on Immunization Practices (ACIP) met to discuss and vote on the committee’s recommendations for the hepatitis B birth dose and the childhood and adolescent vaccination schedule.

On November 25, 2025, the Centers for Medicare & Medicaid Services (CMS) released the maximum fair price (MFP) for each of the 15 selected drugs for IPAY 2027, which will go into effect beginning January 1, 2027. These negotiated prices reflect a marked increase in savings compared to the initial 2026 cohort, influenced by newer drugs and expanded pricing benchmarks.

On November 18, 2025, the Food and Drug Administration (FDA) published a final guidance entitled “Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments” (Final Guidance).