Holland & Knight Health Dose: December 16, 2025

Looking Ahead

The U.S. House of Representatives and U.S. Senate will be in session this week for the last time this year. After votes on proposals from Senate Republicans and Democrats to extend the enhanced advanced premium tax credits (APTCs) failed last week, agreement on a healthcare package looks unlikely to come to fruition this year, and the enhanced APTCs remain on track to expire on Dec. 31, 2025. However, House Speaker Mike Johnson (R-La.) is pursuing a last-ditch effort before adjourning and committed to hold a vote in the House on a Republican-led proposal to reduce healthcare costs called the Lower Healthcare Premiums for All Americans Act. The legislation includes a limited set of pharmacy benefit manager (PBM) reforms – largely focused on transparency and restores cost-sharing reduction payments that were removed by the Senate parliamentarian during consideration of the One Big Beautiful Bill Act, codifies association health plans to allow businesses to pool together to offer coverage and clarifies the treatment of stop-loss insurance. Notably, the package does not include an expansion of health savings accounts nor an extension of the enhanced ATPCs.

At the same time, House leadership continues to seek consensus on allowing an amendment vote on legislation sponsored by Rep. Brian Fitzpatrick (R-Pa.) that would extend expiring Affordable Care Act (ACA) premium subsidies for two years, paired with anti-fraud measures. Though the proposal has bipartisan backing, conservatives are pushing for additional guardrails, and most Democrats – who favor a clean subsidy extension – are unlikely to support it. Given that this is the final week U.S. Congress will be in session in 2025, even if the House advances the legislation – an outcome that may be challenging given opposition – any next steps are likely to carry over into 2026.

Also to be considered on the floor of the House this week are the Protect Children's Innocence Act (H.R.3492), introduced by Rep. Marjorie Taylor Green (R-Ga.), and the Do No Harm in Medicaid Act (H.R.498), introduced by Rep. Dan Crenshaw (R-Texas). The bills would criminalize certain procedures and the provision of medication related to gender-affirming care, as well as prohibit Medicaid programs from using federal funding to support gender-affirming care procedures for minors.

Upcoming Events

• The House Committee on Energy and Commerce will hold a hearing on Dec. 17, 2025, at 10:15 a.m. titled "Examining Biosecurity at the Intersection of AI and Biology." The hearing will focus on biosecurity risks and opportunities at the intersection of artificial intelligence (AI) and biology. The hearing is also expected to explore how emerging technologies impact public health preparedness and national security.
• The House Committee on Veterans' Affairs (VA) Subcommittee on Oversight and Investigations will hold a hearing on Dec. 17, 2025, at 10:15 a.m. titled "Ready, Set, Go-Live: Assessing VA's EHR Modernization Deployment Readiness" to examine the VA's readiness for the next phase of its electronic health record modernization initiative. The hearing will review deployment plans, risk mitigation strategies and lessons learned from prior rollouts.

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.

Personnel Updates

• Marc Veasey (D-Texas) declared on Dec. 8, 2025, that he will not run for reelection following the U.S. Supreme Court's decision to allow Texas to use a new Congressional redistricting map in 2026.
• Jasmine Crockett (D-Texas) also announced on Dec. 8, 2025, that she will run for the Senate.

Congressional Updates

HELP Chair Announces RFI To Support Investigations Into Medical Association Operations

Senate Committee on Health, Education, Labor and Pensions (HELP) Chair Bill Cassidy (R-La.) issued a new request for information (RFI) on Dec. 9, 2025, the next step in his work to review major medical associations, their work and any potential impact on healthcare costs. The RFI asks stakeholders with experience with and knowledge of Current Procedural Terminology (CPT) coding contracts to respond to a questionnaire. The press release announcing availability of the RFI and corresponding questionnaire notes that Chair Cassidy is "committed to finding answers by other means" if a sufficient response is not received, indicating he could be considering more aggressive options to support the investigation.

Democratic Senators Write Drugmakers, Request Details on Drug Pricing Agreements

A group of Democratic senators led by Senate Committee on Finance Chair Ron Wyden (D-Ore.) sent a letter on Dec. 11, 2025, to the CEOs of large pharmaceutical companies who have entered into drug pricing agreements with the Trump Administration. The letter requests additional details on the drug pricing agreements, including information on how the companies plan to offer their products to the Medicaid programs, as well as requesting details on drug pricing arrangements for specific medications in the companies' portfolios. Companies are requested to respond by Jan. 30, 2026. A copy of the letter is available online.

Regulatory Updates

OMB Issues Guidance for Government Procurement of Large Language Models

The Office of Management and Budget (OMB) released Memorandum M‑26‑04 on Dec. 11, 2025, titled "Increasing Public Trust in Artificial Intelligence Through Unbiased AI Principles," establishing two core principles: truth-seeking and ideological neutrality. These principles will guide federal agencies in the acquisition and development of AI systems, including large language models. The goal is to ensure AI outputs are fact-based, scientifically grounded and free from partisan or ideological bias unless explicitly requested by the user.

Agencies must update procurement processes, contracts and internal policies by March 11, 2026, to incorporate these standards. Requirements include transparency measures such as acceptable use policies, model, system, data cards, user guides and incident-reporting mechanisms. Agencies are also encouraged to apply these principles to other types of generative AI capabilities, where applicable.

Violations of these requirements may result in contract termination. The guidance is intended to strengthen public trust in government AI systems and promote responsible procurement of large language models.

CMS Partners with Technology Company to Support Medicare.gov

The Centers for Medicare & Medicaid Services (CMS) announced on Dec. 9, 2025, a new partnership with a technology company to integrate digital identity confirmation processes into Medicare.gov starting in 2026. The partnership will extend to identification verification for the CMS National Provider Directory. The effort further integrates private companies into the federal government's work to modernize healthcare programs, including Medicare. The partnership will also focus on the modernization of account creation and recovery, as well as health information access for Medicare beneficiaries and providers, potentially allowing enrollees to verify their identity with face identification.

CMS Releases New Model and Funding for MAHA ELEVATE

CMS has unveiled the "Make America Healthy Again: Enhancing Lifestyle and Evaluating Value-based Approaches Through Evidence" (MAHA ELEVATE) model, a voluntary initiative that will fund up to 30 chronic disease prevention and health promotion pilot projects aimed at integrating lifestyle and evidence-based functional medicine into Original Medicare.

Under the MAHA ELEVATE model, CMS will make approximately $100 million available to support three-year cooperative agreements for up to 30 proposals that advance health and prevention for Original Medicare beneficiaries. Award funding may be used to provide whole-person care services – including functional or lifestyle medicine – that are not covered under Original Medicare, as well as to support administrative activities and required data collection and reporting. Funds may not be used for food or for services that are otherwise billable to Original Medicare.

The model is similar to one of the Innovation Center's earliest efforts – the Health Care Innovation Awards (HCIA) – in that it will fund cooperative agreements with selected awardees rather than test discrete changes to Medicare or Medicaid payment or service-delivery rules. CMS plans to issue a Notice of Funding Opportunity (NOFO) in early 2026 for the first cohort. The voluntary model is scheduled to launch on Sept. 1, 2026. Additional details will be released with the publication of the NOFO.

FDA RFI on Testosterone Replacement for Men

The U.S. Food and Drug Administration (FDA) issued a RFI on Dec. 10, 2025, discussing testosterone replacement therapy (TRT) for men. The issuance of the RFI coincides with the FDA's Expert Panel on Dec. 10, 2025, on the same topic and follows FDA's announcement on the removal of warning labels for certain hormone therapies for women. The RFI requests information from interested stakeholders on indications, dosing, route of administration, duration of treatment, goals of treatment, including perspectives on the scientific, regulatory and practical implications for testosterone use. Specific questions to stakeholders are:

• What are the potential impacts of TRT on cardiovascular and thromboembolic disease, genitourinary systems, musculoskeletal health, frailty and depression?
• How do the risks and benefits of TRT differ based on timing of hormone initiation, age of initiation of treatment, duration of use, formulation (type of testosterone replacement used), dose and route of administration?
• What are the biggest opportunities to improve education of providers and patients concerning the prescription of TRT?
• How could interested parties – including, but not limited to, drug developers, healthcare providers, patients, consumers and retailers – work together to further identify therapeutic uses of TRT and generate evidence supporting the safety and efficacy of these uses?
• Scientific considerations:
  • FDA seeks input on definitions and diagnostic thresholds for age‑related androgen deficiency.
  • FDA seeks input on research priorities that could enhance the scientific understanding of TRT for men, including areas where additional evidence or data generation may be most valuable.
  • What scientific barriers might limit progress in increasing the availability of TRT?
  • What additional scientific tools, technologies or data sources could support the availability of TRT?
  • Are there specific diseases or conditions that have not traditionally been treated with TRT for which testosterone could be safely and effectively used and which are currently not indicated in FDA-approved product labeling? If so, please provide the data or evidence supporting these potential uses.

FDA Qualifies First AI Tool for Drug Development

FDA announced on Dec. 9, 2025, that it had qualified the first AI drug development tool for use by pathologists in assessing metabolic dysfunction-associated steatohepatitis (MASH) in clinical trials. The qualification process was established by the 21st Century Cures Act. The novel qualification illustrates FDA's continued focus on integrating AI tools into FDA's working and accelerating review and approval/qualification of AI enabled tools to support healthcare processes. The notice includes definitions for countries of concern, human biospecimens and U.S. person, and indicates the biospecimens security policy "applies to all human clinical and research biospecimens obtained from U.S. persons (regardless of identifiability) that are collected, obtained, stored, used or distributed and that are supported or funded by any on-going or new National Institutes of Health (NIH) funding mechanisms (grants, cooperative agreements, contracts, Other Transactions, and intramural support) regardless of NIH funding level."

The policy does not apply to cell derivative products or cell lines derived from human biospecimens of U.S. persons. Finally, the notice lays out a limited set of circumstances for which human biospecimens may be shared or distributed to countries of concern.

FDA Proposes to Expand List of Active Ingredients for Sunscreens

FDA on Dec. 11, 2025, proposed to add bemotrizinol as a permitted active ingredient for use in sunscreens. Bemotrizinol has been used as an active ingredient in sunscreens in other countries, but the FDA has not previously approved an application for a drug product containing bemotrizinol or added it to the sunscreen monograph. FDA is seeking public comment on the proposed order. If and when FDA concludes the ingredient is generally recognized as safe and effective, FDA will issue a final order to add the ingredient to the over-the-counter monograph.

FDA Issues Final Guidance on Promotional Labeling and Advertising for Biosimilar and Interchangeable Biosimilar Products

FDA issued final guidance to assist sponsors when developing FDA-regulated promotional labeling and advertisements for prescription reference products and prescription biosimilar products. Under Section 351(K) of the Public Health Service Act, biological products shown to be biosimilar to or interchangeable with an FDA-licensed reference product may go through an abbreviated licensure pathway. The final guidance answers questions regarding requirements for the content of FDA-regulated promotional communications, including that a biological product be "correctly and specifically" identified as part of the promotional communication.

The final guidance also refers entities to a guidance for industry titled "Medical Product Communications That Are Consistent With the FDA-Required Labeling: Questions and Answers (June 2018)." Entities are recommended to "carefully evaluate promotional communications that compare a reference product and a biosimilar product and avoid presentations that represent or suggest that a licensed biosimilar product is not highly similar to the reference product or that a clinically meaningful difference in terms of safety, purity, or potency exists between the reference product and biosimilar product." Finally, the guidance notes that above all else the promotional communication should be accurate and lays out several example scenarios to illustrate what may or may not be considered permissible.

NIH Issues Notice of Policy on Enhancing Security Measures for Human Biospecimens

The NIH issued a notice of policy on Dec. 11, 2025, to establish new guidelines for the security of human biospecimens collected, obtained, stored, used or distributed using NIH funding. The notice seeks to protect sensitive and personal health-related data from potential misuse by foreign adversaries.

Legal Updates

State AGs File Brief to Block Subpoena for Certain Medical Records

A brief was filed by 20 Democratic attorneys general (AGs) in support of efforts to block the Trump Administration's attempt to force the provision of medical records for minor patients who received gender-affirming care in Colorado. In the brief, the AGs argue the Trump Administration's subpoena for patient information infringes upon states' rights and limits the ability of clinicians to make decisions regarding their patients' health without fear of possible legal action. Other stakeholders have filed similar briefs arguing there is no reasonable justification for minor patient records to be requested.

Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem, and it should not be substituted for legal advice, which relies on a specific factual analysis. Moreover, the laws of each jurisdiction are different and are constantly changing. This information is not intended to create, and receipt of it does not constitute, an attorney-client relationship. If you have specific questions regarding a particular fact situation, we urge you to consult the authors of this publication, your Holland & Knight representative or other competent legal counsel.