AGG Talks: Government Insight for Life Sciences Leaders Podcast Series · Arnall Golden Gregory LLP

Patient Assistance Programs and the False Claims Act: Enforcement Trends and Compliance Risks for Life Sciences Companies

·23 min·1 clip

DOJ and OIG are “hyper-targeted on particular issues,” with life sciences focused on market access, pricing, patient support, and ancillary services.

Patient assistance programs are the risk area on the table. Alan Minsk sets up the conversation through the False Claims Act, reimbursement support, and the compliance pressure on life sciences companies that help patients get to treatment. David Blank adds the OIG angle. His former agency experience gives the episode a practical feel, especially when he talks through how advisory opinions and enforcement interest can take shape inside government. The access problem is not waved away. Some therapies are hard to deliver at all, with manufacturing in a specific location, cold chain delivery, limited treatment sites, and short shelf lives. That leaves companies in a tight spot. Patient support can help people reach therapies they might otherwise miss, but the program design still has to survive scrutiny. Advisory opinions get especially interesting. Blank explains that when one company asks OIG for formal guidance, the agency may assume other companies are using similar arrangements. Enforcement can work the same way once government sees how sales teams, HCP interactions, laboratories, reimbursement support, and related commercial pieces fit together. The tone is cautious, not panicked. Even helpful guidance comes with conditions. It is not a blank check for loose design. Minsk keeps pushing for the inside view, and the best parts come when the discussion moves from legal doctrine to how OIG decides a patient assistance model deserves another look. State enforcement comes up near the end. The close is cautiously optimistic, but Blank flags state activity as something companies should keep watching. The lesson is practical: use patient assistance for access, but build it with safeguards and monitor it across federal and state enforcement channels.

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A measured look at patient assistance programs, reimbursement, and False Claims Act risk.

Patient assistance programs are treated as a live compliance issue where access, reimbursement, and False Claims Act risk intersect. Alan Minsk and David Blank keep the focus on recent developments, and Blank's former OIG perspective gives the discussion added weight when he…

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