Line of Cite: FCA Enforcement Risks for Life Sciences Companies in Patient Assistance and Reimbursement Programs

Event Details

Please join David Blank, AGG Healthcare and Life Sciences partner and former Senior Counsel at the HHS Office of Inspector General (“OIG”), for the second installment of AGG’s Line of Cite webinar series.

As manufacturers and service providers adapt patient assistance and reimbursement programs to meet market and patient needs, enforcement authorities are increasingly focused on the intersection of commercial operations, financial assistance, and compliance obligations. Drawing on his experience at OIG and in private practice, David will analyze recent enforcement trends, highlight key risk areas, and provide practical compliance guidance to mitigate exposure under the FCA and related statutes. AGG Life Sciences co-chair Alan Minsk will moderate the session.

Topics

• How FCA enforcement priorities influence compliance expectations for patient support programs.
• Common pitfalls in patient assistance and reimbursement program design.
• Lessons from recent DOJ and OIG settlements impacting life sciences manufacturers.
• Best practices for strengthening compliance frameworks and responding to regulatory inquiries.
• Forward-looking insights into 2026 enforcement trends and what life sciences companies should anticipate.

AGG’s “Line of Cite” webinar series features AGG’s team of former government attorneys speaking on current developments and enforcement updates across their respective agencies, including the DOJ and HHS.

There will be an opportunity for Q&A at the end of this webinar.

Credits: 1 hour of CLE credit has been approved by the State Bar of Georgia.

Recording

To watch a recording of the webinar, please click here.