Regulatory NewsBREAK: CMS Issues Final Negotiated Prices for Initial Price Applicability Year 2026

On August 11, 2026, the Centers for Medicare and Medicaid Services issues a final rule titled, “Prohibition on Federal Medicaid and Children’s Health Insurance Program Funding for Sex-Rejecting Procedures Furnished to Children” (Final Rule). The Final Rule prohibits payments to State Medicaid plans for “sex-rejecting procedures” for children under 18 or to a separate Children’s Health Insurance Program (CHIP) for children under 19. Among the definitions included in the Final Rule are:

On August 10, 2026, President Trump signed an Executive Order titled, Delivering Gold Standard Childhood Vaccine Recommendations for Americans (the EO). The EO recommends all children get immunizations for 11 diseases, a decrease from the 18 diseases recommended by the Centers for Disease Control and Prevention in 2024. The EO states that immunizations that are no longer recommended for all children are now recommended for shared clinical decision-making.

On July 31, 2026, the Health Resources and Services Administration (HRSA) announced (Notice) a revised 340B Rebate Model Pilot Program (Pilot) that would allow participating drug manufacturers to provide 340B discounts through retrospective rebates.