In this episode, AGG Life Sciences co-chair Alan Minsk is joined by AGG Healthcare and Life Sciences partner David Blank, former Senior Counsel at the HHS Office of Inspector General ("OIG"), for an in-depth discussion on Patient Assistance Programs ("PAPs"), the False Claims Act ("FCA"), and evolving enforcement priorities impacting life sciences companies.

Drawing on his experience at OIG and advising companies today, David unpacks how DOJ and OIG are approaching market access, patient support, and reimbursement arrangements — including PAPs, sponsored genetic testing, and vendor relationships. He explores enforcement trends, the role of data analytics and whistleblowers, and why state-level enforcement may represent the next major compliance challenge for the industry.

This episode builds on themes David previously addressed during an AGG-hosted webinar, "Line of Cite: FCA Enforcement Risks for Life Sciences Companies in Patient Assistance and Reimbursement Programs," and offers timely insights for companies navigating a rapidly shifting compliance landscape.

In this episode, AGG Life Sciences co-chair Alan Minsk and Healthcare partner Andrew Tsui examine how the Centers for Medicare & Medicaid Services ("CMS") may apply the Medicare Conditions of Participation ("COPs") to emerging areas of healthcare, including gender-affirming care — and what those developments could mean for pharmaceutical companies and drug manufacturers.

They discuss how updates to COPs can impact operational requirements for healthcare providers and influence compliance considerations. Andrew also examines how these changes could ripple through payor markets, pharmaceutical coverage, and the broader regulatory framework affecting the life sciences industry.

With his experience as former litigation counsel at HHS’s Office of the General Counsel, CMS Division, Andrew shares strategies that life sciences leaders can implement to adapt to modern regulatory and compliance actions.

In this episode, Alan Minsk, AGG Food & Drug practice chair and Life Sciences co-chair, and Gabe Scannapieco, Litigation and Healthcare partner and Life Sciences co-chair, unpack recent shifts at the U.S. Department of Justice that could reshape regulatory risk for life sciences organizations.

They discuss the disbanding of DOJ’s Consumer Protection Branch ("CPB") and what the loss of centralized oversight could mean for coordinated investigations in the industry. The conversation also examines DOJ’s intensified focus on counterfeit drugs and its targeting of the entire supply chain in collaboration with FDA, DEA, and other agencies.

Drawing on Gabe’s experience as a former assistant director at the CPB and the firm's extensive regulatory services, this episode provides practical insights for companies looking to stay ahead of shifting enforcement priorities.