New HHS-OIG Guidance: Mitigating AKS Risks in Direct-to-Consumer Prescription Drug Sales to Federal Healthcare Enrollees

This CLE webinar will examine the recent HHS-OIG guidance related to prescription drug manufacturers' direct-to-consumer (DTC) programs involving sales to patients who are also enrolled in federal healthcare programs and how to mitigate federal Anti-Kickback Statute (AKS) risks. The panel will discuss how the guidance may help covered stakeholders proceed with developing compliant DTC programs and also address remaining questions and risks to be considered. The panel will offer best practices for stakeholder compliance in this evolving regulatory area.

Under an administration focused on lowering prescription drug prices and with the expansion of manufacturer-led DTC prescription drug programs, HHS-OIG recently published guidance, including its first Special Advisory Bulletin (SAB) in nearly 12 years, addressing how the AKS applies to DTC prescription sales by drug manufacturers to cash-paying patients who are also enrolled in federal healthcare programs. The guidance is timely given that HHS-OIG and DOJ have historically expressed concern that certain manufacturer DTC and telehealth arrangements may violate federal law.

HHS-OIG explains that, although AKS is a criminal statute requiring case-by-case, fact-specific assessment, DTC programs may present a low risk of AKS violation if they meet certain conditions, including that the patient have a valid prescription issued by an independent, third-party prescriber; that no claims for the drugs are submitted to any insurer, including a federal healthcare program; and that the manufacturer does not use the DTC program for one product as a vehicle to market other federally reimbursable products it provides.

However, the scope of the guidance is very narrow and leaves significant questions unanswered including those surrounding the numerous other arrangements drug manufacturers may have when operating a DTC program that could implicate AKS. Additionally, in response to the guidance, Senators Durbin, Warren, and Welch sent a detailed letter to the HHS Inspector General raising concerns that the guidance leaves core legal and policy issues unresolved, specifically referencing the TrumpRx platform and potential compliance issues.

Listen as our expert panel examines the recent HHS-OIG guidance related to manufacturers' DTC prescription drug programs and AKS implications. The panel will discuss how the guidance may help covered stakeholders proceed with developing compliant DTC programs, but also address open questions and risks to be considered. The panel will offer best practices for stakeholder compliance to mitigate the risk of AKS violation.