Health Law Advisor

On February 19th, Brenna Jenny, Deputy Assistant Attorney General for the Commercial Litigation Branch at the U.S. Department of Justice, provided the keynote speech at the Federal Bar Association’s Qui Tam Conference.

At this address, and in an earlier panel discussion centering on Diversity, Equity, and Inclusion programs (DEI), Jenny focused on False Claims Act (FCA) enforcement priorities and DOJ enforcement practices, including how DOJ identifies cases, when it might dismiss cases, and its approach to resolutions.

It’s time for an update on what to consider before opening and investing in a medical spa. As we’ve written in Part I and Part II of our series, state laws and regulations are constantly evolving for medical spas. As states increasingly regulate this area owners and operators should be aware of current or potential state laws affecting their scope of practice, licenses and registrations, and other key elements.

On January 16, the IRS released two documents – Notice 2026-8 and Rev. Proc. 2026-8 – which provide updated guidance for organizations regarding group tax exemptions.

The guidance also removes the 5+ year moratorium on new exemption rulings. The guidance modifies and supersedes Rev. Proc. 80-27, and incorporates updates from the 2020 notice (Notice 2020-36).

Central organizations and those of their subordinates that are included in the group exemption will generally have one year to come into compliance with the updated guidance. Under IRS Treasury regulations and related guidance, specifically regarding group exemption letters, a central organization is defined as the head or parent organization that holds a group exemption letter and exercises general supervision or control over one or more subordinate organizations. A subordinate organization is defined as a "chapter, local, post, or unit of a central organization".

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: