2025 Year-End U.S. Healthcare and Insurance Regulatory Update

In the final week of the 2025 U.S. congressional session, healthcare legislation faces significant challenges. Extensions of enhanced advanced premium tax credits (APTCs) are unlikely to be passed before the December 31, 2025 expiration date after Senate proposals failed. House Speaker Mike Johnson plans a vote on the Lower Healthcare Premiums for All Americans Act, focusing on pharmaceutical benefit manager transparency, restored cost-sharing reductions, association health plan codification, and stop-loss insurance clarification, but excluding expanded health savings accounts or APTC extensions. Simultaneously, House leaders are negotiating to allow a vote on a bipartisan bill by Rep. Brian Fitzpatrick to extend ACA premium subsidies for two years with added anti-fraud measures. Conservative opposition and Democratic preference for a clean extension may stall progress, and any action may carry into 2026. Legislation related to gender-affirming care, including the Protect Children's Innocence Act and the Do No Harm in Medicaid Act, will also be considered, focusing on criminalizing certain procedures and limiting Medicaid funding for gender-affirming care for minors. The Trump Administration continues issuing executive orders, with ongoing tracking of updates. Senate HELP Committee Chair Bill Cassidy issued a request for information on CPT coding contracts, signaling potential further investigation into medical associations and healthcare costs. A group of Democratic senators led by Finance Committee Chair Ron Wyden requested detailed information from pharmaceutical CEOs about drug pricing agreements with the federal government. Responses are due by January 30, 2026. The Office of Management and Budget (OMB) released guidelines emphasizing unbiased AI principles for federal agencies, aiming to foster trust in AI by ensuring truthfulness and ideological neutrality in AI procurement and development. Agencies must comply by March 2026. CMS announced a digital identity verification partnership to modernize Medicare.gov account processes, potentially integrating biometric verification for beneficiaries and providers starting in 2026. Additionally, CMS introduced the voluntary MAHA ELEVATE model to support lifestyle and functional medicine initiatives for chronic disease prevention in Original Medicare, allocating about $100 million for pilot projects. The FDA issued a request for information on testosterone replacement therapy and qualified an AI drug development tool for assessing metabolic dysfunction-associated steatohepatitis, indicating increased FDA engagement with AI in healthcare research and regulation. The FDA proposed adding bemotrizinol to approved sunscreen ingredients and issued final guidance on promotional labeling for biosimilar biological products, focusing on accuracy and compliance in marketing communications. NIH released new biospecimen security policies to safeguard human biospecimens funded by NIH grants from misuse by foreign entities. Legal actions continue around gender-affirming care involving subpoenas for medical records, with multiple states supporting efforts to protect patient privacy and clinical decision-making freedom. Overall, these developments highlight ongoing regulatory, legislative, and technological intersections affecting U.S. healthcare and insurance markets, emphasizing transparency, cost control, compliance, and modernization initiatives impacting payers, providers, and policy frameworks in 2025 and beyond.