On April 21, 2026, the Centers for Medicare & Medicaid Services (CMS) issued a Status Update on the Medicare GLP-1 BRIDGE Demo and BALANCE Model in Part D for CY 2027.

On April 23, 2026, the Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway to accelerate Medicare coverage for certain FDA-designated Breakthrough Devices by aligning evidence requirements and coverage decisions earlier in development.

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On February 23, 2026, the U.S. Food and Drug Administration (FDA) released draft guidance outlining a new regulatory framework to support approval of individualized therapies for ultra-rare diseases when randomized controlled trials are infeasible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