US Congress Advances Healthcare Legislation; FDA Launches Agentic AI; CMS Updates Payments

As the U.S. Congress resumes work after the Thanksgiving break, lawmakers face a tight schedule to pass critical healthcare and appropriations legislation before the end of the year. The House is advancing multiple bills under suspension of rules, including the Give Kids a Chance Act which empowers the FDA to require pediatric cancer drug combination trials, reauthorize the pediatric rare disease priority review voucher program, and enhance transparency for generic manufacturers. However, legislative alignment between the House and Senate continues to evolve. In appropriations, Senate Majority Leader John Thune is attempting to move a FY 2026 minibus package that may consolidate Defense, Labor-HHS, Transportation-HUD, and Commerce-Justice-Science funding. Progress depends on unanimous consent amidst competing priorities, including judicial and executive nominations. The National Defense Authorization Act (NDAA) for FY 2026 is also nearing final agreement, with public text expected soon. Key Senate committee hearings include Senate HELP's examination of healthcare affordability and nominations, and a Senate Veterans Affairs hearing focused on medication management within VA healthcare. The Senate Finance Committee postponed hearings on organ transplantation networks to December 11. These sessions reflect ongoing congressional scrutiny of healthcare system challenges and veterans' medical services. Separately, the Trump Administration has enacted a trade agreement with the United Kingdom that exempts UK-origin pharmaceuticals and medical technology from tariffs, in exchange for the UK reducing rebate rates to its national health service. This bilateral agreement addresses long-standing pharmaceutical pricing concerns and limits trade disputes over UK drug pricing during the presidential term. A major issue looming in healthcare policy is the impending expiration of enhanced ACA premium subsidies on December 31, 2025. Senators and House Republicans remain divided on the extension, with Democrats favoring a clean extension while GOP proposals pivot towards health savings accounts and insurance pooling alternatives. Legislative consensus appears uncertain, and a Senate HELP Committee hearing will review these proposals. The FDA has deployed agentic AI tools within a secured GovCloud environment, enhancing capabilities to streamline complex regulatory functions such as pre-market reviews, post-market surveillance, and compliance checks. The agency continues to prioritize data security and human oversight, with plans to stimulate innovation through forthcoming challenges. CMS launched the ACCESS Model, a 10-year voluntary program to empower clinicians with outcome-based payment models addressing chronic diseases in Original Medicare beneficiaries. This initiative aims to advance technology-supported care while providing flexibility in clinical practice starting July 1, 2026. CMS also implemented significant 2026 updates to payment policies affecting post-acute care and durable medical equipment sectors. Notably, home health payments will increase by 2.4%, quality measurement programs are being revised for digital interoperability, and the Home Health Value-Based Purchasing model is expanded. The DMEPOS accreditation and competitive bidding processes will see enhanced oversight, modernized methodologies, and inclusion of new product categories such as ostomy supplies. Additionally, CMS continues efforts to combat Medicare fraud through its Crushing Fraud Chili Cook-Off Competition, leveraging explainable AI and machine learning to forge proactive program integrity tools targeting high-risk sectors like hospice and durable medical equipment. On regulatory oversight, Senate HELP Ranking Member concerns have been raised about the FDA’s National Priority Voucher pilot program potentially exposing vulnerabilities related to expedited drug approvals and agency staffing reductions, requesting formal agency responses. Overall, these legislative and regulatory developments underscore ongoing efforts to refine U.S. healthcare system efficiency, maintain robust oversight, and balance policy priorities amid fiscal constraints and technological innovation.