Health Law Advisor

A newly introduced House Bill, H.R. 7366, titled the Dietary Supplement Regulatory Uniformity Act, would amend the Federal Food, Drug, and Cosmetic Act (“FDCA”) to expressly clarify and affirm the Food and Drug Administration’s (“FDA”) preemptive authority over dietary supplement regulation.

The bill would prohibit states from establishing or maintaining dietary supplement requirements that are different from or in addition to federal requirements, unless a state successfully applies for a specific exemption from FDA preemptive authority. Such exemptions would be limited to circumstances where a state requirement is more stringent than federal law or addresses a compelling local condition without placing a product out of compliance with federal standards.

In effect, the proposed legislation reinforces a uniform national regulatory framework for dietary supplements, while preserving a narrow pathway for state involvement under FDA oversight.

As 2025 drew to a close, the Centers for Medicare & Medicaid Services (“CMS”) issued proposed rules for two mandatory pricing models aiming to reduce out-of-pocket costs for Medicare drugs.

During a recent industry webinar, Cara Welch, Ph.D., Director of the Office of Dietary Supplement Programs (“ODSP”) within the U.S. Food and Drug Administration (“FDA”), outlined the agency’s 2026 priorities for the dietary supplement industry. Dr. Welch’s remarks reflect both continuity in FDA’s long-standing focus areas and a push toward modernization within existing statutory authority.

Last week, the OIG posted two important issuances on Direct to Consumer drug programs, including TrumpRx – a Special Advisory Bulletin and a Request for Information (RFI). These issuances follow the announcement of Most Favored Nation Direct to Consumer pricing last May in White House Executive Order 14297, “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” (May 12, 2025).

On January 16, 2025, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 26-01, offering clarity as to whether a manufacturer may waive patient cost-sharing amounts for certain insured individuals receiving its clinical diagnostic test without triggering liability under the Federal health care fraud and abuse laws.

Following CES2026, OpenAI and Anthropic announced consumer-facing generative AI products for health care. OpenAI launched ChatGPT Health on January 7, 2026, and Anthropic followed with Claude for Healthcare on January 11, 2026. Both products allow users to connect their medical records and wellness data directly to these AI chatbots, marking a significant change from theoretical benchmark performance to deployment of consumer health applications.

On December 29, 2025, the U.S. Department of Health and Human Services (“HHS”) Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (“ASTP/ONC”) published two proposed rules in the Federal Register:

As the health care industry transitions beyond the COVID-19 public health emergency era, Congress continues to demonstrate bipartisan support for expanding access to telehealth.

However, telehealth providers will invariably encounter certain legal and regulatory complexities as lawmakers work toward establishing a more permanent regulatory framework. At the same time, states are moving from broad expansion to refinement, focusing on reimbursement precision and licensure compacts.

We are pleased to once again release our latest update to our Telemental Health Laws app, an extensive compilation of laws, policies, and other state guidance for practitioners supporting the mental/behavioral health practice disciplines.

The survey’s complete findings are available to download for free as an app for iPhone, iPad, and Android devices.

On January 5, 2026, the Office of Inspector General (“OIG”) for the Department of Health and Human Services published Advisory Opinion No. 25-12 (“AO 25-12”), an unfavorable opinion regarding sign-on bonuses offered to caregivers who provide in-home support services to Medicaid recipients.

The Trump Administration continues to pursue a policy of AI dominance, which began with its January 23, 2025 executive order to remove “barriers” to Artificial Intelligence (“AI”) innovation to promote “human flourishing, economic competitiveness and national security.” On December 11, 2025, the Administration issued another executive order announcing a policy to remove state law impediments to adopting a “minimally burdensome national standard” for AI development and use.