Holland & Knight Health Dose: December 3, 2025

Looking Ahead

Following a brief Thanksgiving holiday break, U.S. Congress faces just a handful of legislative days before year-end, and the next two weeks promise a crowded calendar as lawmakers race to meet major deadlines.

This week, the U.S. House of Representatives plans to take up to 22 measures under suspension of the rules, requiring a two-thirds vote for passage. On healthcare, the House passed the Give Kids a Chance Act, now renamed in honor of Mikaela Naylon, on Dec. 1. The bill (H.R. 1262) authorizes the U.S. Food and Drug Administration (FDA) to require trials of new pediatric cancer drugs in combination therapies, reauthorize the pediatric rare disease priority review voucher program and require FDA to inform generic manufacturers of differences from reference drugs. Due to convergence in House and U.S. Senate bill text, a way forward is still taking shape.

On appropriations, Senate Majority Leader John Thune (R-S.D.) is working to advance the next fiscal year (FY) 2026 minibus with potential to combine Defense, Labor, Health and Human Services, Transportation-Housing and Urban Development (HUD), and Commerce, Justice, Science and Related Agencies (CJS), with Interior as a possible add-on. Passage will require unanimous consent, and leadership is currently testing the water for objections. The Senate may also revisit the failed Defense vehicle, though floor time is tight with judicial and executive nominees. House Republicans are expected to wait for Senate movement before acting.

Finally, National Defense Authorization Act (NDAA) negotiators aim to finalize the FY 2026 text this week, with public release expected shortly.

Upcoming Events

The Senate Committee on Health, Education, Labor, and Pensions (HELP) will hold a full committee hearing titled "Nomination Hearing" on Dec. 3, 2025, at 9:45 a.m.

The Senate HELP Committee will hold a full committee hearing titled "Making Health Care Affordable Again: Healing a Broken System" on Dec. 3, 2025, at 10 a.m.

The Senate Committee on Veterans' Affairs will hold a full committee hearing titled "Medication Management in VA Healthcare" on Dec. 3, 2025, at 4 p.m.

As a reminder, the Senate Committee on Finance has postponed a full committee hearing titled "Hearings to Examine the Future of the U.S. Organ Procurement and Transplantation Network" to Dec. 11, 2025, at 11 a.m.

Administrative Updates

Executive Order Updates

The Trump Administration has continued to release wide-ranging executive orders (EOs). For the latest updates, see our "Trump's 2025 Executive Orders: Updates and Summaries" tracking chart.

• Launching the Genesis Mission: On Nov. 24, 2025, President Donald Trump issued an EO to launch the Genesis Mission aimed at boosting innovation through the use of artificial intelligence (AI). The EO builds on President Trump's EO, "Removing Barriers to American Leadership in Artificial Intelligence" (Jan. 23, 2025), and the Trump Administration's "Winning the Race: America's AI Action Plan" (July 2025). According to the U.S. Department of Energy, the Genesis Mission will focus on addressing three "key challenges of national importance": American energy dominance, advancing discovery science and ensuring national security.

U.K.-U.S. Pharmaceutical Trade Agreement

The Trump Administration finalized a trade agreement with the United Kingdom that exempts British-origin pharmaceuticals, ingredients and medical technology from Section 232 tariffs. In exchange, the U.K. will reduce rebates drugmakers pay to the National Health Service, lowering the clawback rate from roughly 23 percent to 15 percent and increasing the net price for new medicines by 25 percent. The U.S. also agreed not to target U.K. drug pricing practices in certain trade investigations during President Trump's term. The deal resolves a key sticking point in the broader trade framework negotiated earlier this year and addresses long-standing industry concerns over the U.K.'s voluntary scheme for branded medicines pricing, access and growth (VPAG).

Personnel Updates

• The Senate has confirmed several key U.S. Department of Health and Human Services (HHS) officials, including Brian Christine as assistant secretary for health, Alex J. Adams as assistant secretary for family support at the Administration for Children and Families (ACF), Gustav Chiarello as assistant secretary for financial resources; Michael Stuart as HHS general counsel and Alicia Jackson as director of the Advanced Research Projects Agency for Health (ARPA-H).

ACA Premium Subsidies

The most urgent issue that remains is the expiration of the enhanced Affordable Care Act (ACA) premium subsidies on Dec. 31, 2025. While President Trump briefly weighed a two-year extension before Thanksgiving, GOP resistance has made White House action unlikely. Senate Majority Leader Thune has pledged a vote next week. Democrats will push for a clean extension, while House Republicans are exploring alternatives focused on Health Savings Accounts (HSAs) and insurance pooling, though Hyde Amendment concerns persist. Neither approach appears to have 60 votes. The Senate HELP Committee will examine these proposals in a hearing this week, and House GOP leaders are debating whether to roll out their own healthcare package in December 2025.

Regulatory Updates

FDA Deploys Agentic AI

The FDA has launched agentic AI capabilities across the agency, marking a major step in modernizing its operations. Unlike traditional AI, agentic AI systems can plan, reason and execute multi-step tasks, enabling FDA staff to streamline complex processes such as pre-market reviews, post-market surveillance, inspections and compliance checks. Built within a secure GovCloud environment, these tools prioritize human oversight and data security, with the promise of ensuring no training occurs on sensitive industry data. This initiative follows the rollout of the FDA's large language model (LLM)-based tool, Elsa, and includes an upcoming Agentic AI Challenge to foster innovation. According to FDA Commissioner Marty Makary, the move will "radically improve our ability to accelerate more cures and meaningful treatments."

ACCESS Model Launch

The Centers for Medicare & Medicaid Services (CMS) launched on Dec. 1, 2025, the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model, a voluntary 10-year initiative to expand technology-supported care for people with Original Medicare. Beginning July 1, 2026, ACCESS will test an outcome-based payment approach that gives clinicians flexibility to deliver modern care for common chronic conditions such as high blood pressure, diabetes, chronic musculoskeletal pain and depression. Applications open Jan. 12, 2026, with an initial deadline of April 1, 2026, and interested organizations can complete the ACCESS Model Interest Form to receive updates. By aligning payments with results rather than activities, ACCESS aims to provide clinicians and patients with more choices to prevent and manage chronic disease, supporting innovation and better health outcomes for millions of Americans.

2026 Home Health Prospective Payment System Update and DMEPOS CBP Update Final Rule

CMS has issued one of its most significant payment updates in years, reshaping post-acute care and durable medical equipment (DME) policy. The rule updates the 2026 wage index and national payment amounts, resulting in a 2.4 percent home health payment increase, and recalibrates the fixed dollar loss ratio to maintain statutory outlier spending limits. It also revises the Home Health Quality Reporting Program by removing the COVID-19 vaccine measure and four OASIS items, adopting a new Home Health Care Consumer Assessment of Healthcare Providers and Systems (HHCAHPS) survey in April 2026, and updating reconsideration processes for non-compliant agencies. CMS addresses stakeholder feedback on digital quality measurement, fast healthcare interoperability resources (FHIR) adoption and future interoperability-focused measures, while expanding the Home Health Value-Based Purchasing Model with new measure removal factors, added function- and spending-based metrics and adjusted weights.

The rule introduces sweeping reforms to the DME, prosthetic devices, prosthetics, orthotics and supplies (DMEPOS) accreditation process, requiring annual supplier reaccreditation, enhanced application organization (AO) reporting and expanded CMS oversight. It finalizes refinements to the Competitive Bidding Program (CBP), including a timeline for bidding through 2027 and contracts effective by January 2028, modernized information technology (IT) systems, and revised bid methodologies. CMS also reclassifies all continuous glucose monitors and insulin pumps under the frequent servicing category, clarifies payment caps for Class III products and expands CBP to include ostomy and urological supplies, despite stakeholder objections. A new Remote Item Delivery CBP framework will cover items typically furnished from remote locations, such as continuous glucose monitors (CGMs), insulin pumps, ostomy supplies and off-the-shelf braces. CMS anticipates contract awards for these categories in 2026, with provisions to protect beneficiary access during transitions.

Medicare Physician Fee Schedule (MPFS) Correcting Notice

While these appear administrative, the updates have direct implications for reimbursement of skin substitute products.

Key changes include:

• CMS revised language in the final rule to clarify that skin substitutes are biological products, removing the prior reference to "drug or biological products."
• Payment-rate descriptions were corrected across several physician fee schedule (PFS) tables.
• The finalized calendar year (CY) 2026 Medicare payment rate for skin substitutes is $127.14/cm². Notably, this revised amount aligns with the rate published in last week's Outpatient Protective Payment System (OPPS) Final Rule.

CMS Chili Cookoff Advances 10 Tech Companies

CMS has advanced 10 tech companies to the second round of its Crushing Fraud Chili Cook-Off Competition, a research challenge designed to advance program integrity through explainable AI and machine learning. The initiative invited participants to develop transparent, scalable models to curtail fraud, waste and abuse in Medicare Fee-for-Service claims, particularly in hospice, Part B and durable medical equipment, and translate those findings into actionable fraud indicators. The challenge for participants is to move beyond reactive audits toward proactive fraud prevention while keeping humans meaningfully in the loop. Finalists applied their models to CMS Limited Data Sets and submitted policy recommendations alongside technical solutions. More information can be found online.

Health Leaders Pose Questions About New FDA Priority Review Program

Senate HELP Committee Ranking Member Bernie Sanders (I-Vt.) and House Committee on Energy and Commerce Ranking Member Frank Pallone (D-N.J.) have written to the FDA regarding the recently announced Commissioner's National Priority Voucher pilot program. "We have significant concerns that this program will enable corruption by creating a new, lucrative gift for drugmakers and allies politically favored by President Trump," the lawmakers state. "This program could undermine public confidence in FDA's decisions and raise safety concerns, including rushed reviews by an agency whose staff have been decimated by this administration's cuts." They pose a series of questions about the program and request a response from FDA Commissioner Makary by Dec. 11, 2025.

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