April 2025 update on U.S. pharmaceutical regulation highlights executive orders, budget changes, CMS policies, IRA litigation, and 340B program developments shaping drug pricing and access.

The Health Tech Investment Act aims to create a consistent Medicare payment system for FDA-approved AI medical devices, enhancing patient access and improving healthcare outcomes.

Dr. Mehmet Oz confirmed as CMS leader, emphasizing Medicare and Medicaid modernization, targeting fraud, and navigating potential Medicaid funding challenges amid federal budget pressures.

Holly Hill mental health hospital in North Carolina addresses CMS and NCDHHS compliance issues to maintain Medicare program eligibility. Follow-up inspection results pending.

CMS finalizes key elements of the CY 2026 Medicare Advantage and Medicare Part D final rule, including insulin coverage expansion, Prescription Payment Plan codification, pharmacy data requirements, and updated enrollee protections.

CMS increases 2026 Medicare Advantage reimbursement rates to 5.06%, easing insurer pressures while adjusting policies on obesity drug coverage and billing practices.

CMS drives healthcare efficiency with initiatives like the HL7 FHIR Connectathon, Oklahoma directory pilot, HIPAA updates, and new prior authorization rules for Medicare and Medicaid.

The Trump administration's 2026 draft budget proposes a one-third reduction in HHS funding, affecting NIH, CDC, CMS, and rural health programs, with key agency restructures and policy shifts.

Democratic governors oppose Trump-era CMS rule limiting state control over ACA health insurance marketplaces, citing disruption to enrollment, eligibility, and essential benefits coverage.

Federal budget cuts targeting Medicare and Medicaid create challenges for Arizona's healthcare system, threatening rural hospitals and vulnerable populations dependent on AHCCCS coverage.