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ARTICLE · 04 AUGUST 2026

Walking The Line: Navigating AKS Risk In Pharmaceutical Speaker Programs And Patient Support

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Speaker programs and patient support programs (PSPs) offered by pharmaceutical manufacturers remain under intense government scrutiny. This brief summarizes the current enforcement climate, relevant Department of Health & Human Services Office of Inspector General (HHS-OIG) advisory opinions, and practical guidance for compliance teams navigating this evolving landscape.

United StatesFinance and Banking
Meredith Williams
Meredith Williams
Caila Wagar
Caila Wagar
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Speaker programs and patient support programs (PSPs) offered by pharmaceutical manufacturers remain under intense government scrutiny. This brief summarizes the current enforcement climate, relevant Department of Health & Human Services Office of Inspector General (HHS-OIG) advisory opinions, and practical guidance for compliance teams navigating this evolving landscape. The federal Anti-Kickback Statute (AKS) remains the primary tool for regulating PSPs and speaker programs. Under the AKS, it is illegal to knowingly and willfully offer, pay, solicit, or receive remuneration to induce or reward referrals of items or services reimbursable by federal healthcare programs. False Claims Act liability attaches when AKS violations taint claims submitted to federal programs. 

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