Direct-to-Consumer Prescription Drug Models: Recent HHS-OIG Guidance, Enforcement Trends, Emerging Business Models

This CLE webinar will examine healthcare regulatory compliance implications and contracting considerations within emerging direct-to-consumer (DTC) drug programs, including the recent HHS-OIG guidance related to prescription drug manufacturers' 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 recent DTC trends and business models, explain how stakeholders can develop compliant DTC programs, and address remaining questions and risks to be considered. The panel will offer best practices for stakeholder compliance in this evolving regulatory area.

The current administration's approach to prescription drug prices has included both formal regulatory proposals and informal political pressure on drug manufacturers to align U.S. prices with those of other developed nations and to promote transparency in drug pricing. At the same time, there has been a groundswell in interest by drug manufacturers and other stakeholders in developing DTC channels for prescription drugs. This has generated an unprecedented expansion of manufacturer-led DTC prescription drug programs. 

DTC programs may implicate several regulatory compliance regimes, and 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.

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.

At the same time, drug manufacturers and other stakeholders continue to face a litany of other challenges when establishing DTC programs, including government price reporting requirements, impact on PBM and payor contracts, and risks to dispensing pharmacies.

Listen as our expert panel provides an overview of emerging DTC models and their strategic, contractual and legal implications under multiple regulatory regimes, and 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 compliance by manufacturers, pharmacies, and administrative service providers to mitigate compliance risks.