Gender-Affirming Care Investigations Response Team

The Department of Justice (“DOJ”) and the U.S. Department of Health and Human Services Office for Civil Rights have launched aggressive investigations into hospitals, universities, pharmaceutical companies, physicians, and other healthcare providers for potential violations of the Federal Food, Drug, and Cosmetic Act (“FDCA”) in connection with the sale or distribution of drugs used in gender-affirming care. In addition, the DOJ has been directed to pursue False Claims Act (“FCA”) cases against providers accused of fraudulently billing federal healthcare programs — including Medicaid — for gender-affirming care.

Against this backdrop, institutions also face escalating political pressure and enforcement risks, including funding cuts to universities, challenges to hospital revenue streams, and federal- and state-level efforts to restrict access to gender-affirming treatments.

AGG’s Gender-Affirming Care Investigations Response Team combines former senior-level government experience at DOJ, HHS-OGC, and HHS-OIG with a defense-side approach designed to safeguard our clients’ funding, operations, and reputations. Our team understands the legal, political, and reputational dynamics driving these investigations and brings that knowledge to bear in defending providers and protecting access to care.

Who We Represent

• Academic medical centers and universities at risk of losing hundreds of millions in federal research and clinical grants
• Hospitals and children’s hospitals facing DOJ or state attorney general investigations related to gender-affirming care
• Pharmaceutical and life sciences companies investigated for the sale, distribution, or promotion of drugs used in gender-affirming care
• National and regional healthcare organizations engaged in litigation or amicus advocacy to protect patient access to treatment

How AGG Supports Clients

Our Gender-Affirming Care Investigations Response Team provides defense, compliance, and advocacy to protect providers and institutions from government investigations, funding risks, and politically driven enforcement:

• Defense of DOJ and state attorney general investigations under the FDCA, FCA, and other federal and state statutes
• Internal investigations into prescribing, billing, and compliance practices
• Compliance audits and program updates addressing HIPAA, billing, and evolving federal/state requirements
• Litigation defense and impact advocacy in cases challenging restrictive state actions or defending access to care
• Guidance on protecting federal grants and reimbursement streams at risk of suspension or termination
• Amicus strategy and coalition engagement with national health associations to amplify provider voices
• Crisis management and communications support to safeguard institutional reputation in politically charged environments

We offer rapid response capability for clients facing urgent inquiries or subpoenas involving these emerging legal theories. We also work closely with general counsel, compliance officers, and HR leaders to proactively assess and adjust their internal policies, particularly those related to DEI initiatives, employment practices, and federal grant or contract certifications, to minimize exposure and demonstrate compliance.

Anticipating Enforcement Priorities to Protect Our Clients

Led by attorneys who have recently served in senior leadership roles in the government, our team brings an insider’s perspective to help clients anticipate enforcement priorities and respond effectively.

We pair this government experience with a deep bench of healthcare regulatory, enforcement, and trial counsel who routinely advise academic medical centers, universities, hospitals, and life sciences companies on compliance, reimbursement, affiliations, and investigations. This combination of regulatory insight and litigation capability enables us to protect client funding, defend against government actions, and design proactive compliance strategies that reduce future risk.