New HHS-OIG Guidance: Mitigating AKS Risks in Direct-to-Consumer Prescription Drug Sales to Federal Healthcare Enrollees
DTC Program Characteristics Presenting Low Risk of AKS Violation; Remaining Questions and Potential Issues for Covered Stakeholders
About the Course
Introduction
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.
Description
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.
Presented By
Mr. Dresser is a partner in Frier Levitt’s Life Sciences Department and heads the firm’s Pharmacy Practice Group. His practice is dedicated to representing a broad cross-section of pharmacies and pharmacy providers, including community retail pharmacies, chain pharmacies, compounding pharmacies, specialty pharmacies, mail order pharmacies, home infusion providers, and dispensing physician practices. Mr. Dresser represents pharmacy providers nationally on issues with payors and Pharmacy Benefit Managers (PBMs), including PBM audit appeals, network terminations, network access and credentialing applications, and reimbursement issues. In addition to his work with pharmacy clients, he also represents a variety of other entities across the healthcare and life sciences spectrum, including other healthcare providers, pharmaceutical and biotech manufacturers, pharmaceutical wholesalers and distributors, and healthcare technology companies. Through this work, Mr. Dresser has focused on the intersection between the law and economic considerations, including drug pricing, marketing techniques, and benefits management.
Mr. Metro is a member of the Life Sciences Health Industry Group, practicing in the area of health care regulatory law. His practice focuses on counseling health care manufacturers, distributors and providers on reimbursement, regulatory, and fraud and abuse issues. For more than 20 years, Mr. Metro has provided analysis and counseling on behalf of manufacturers with respect to government pricing matters including: the Medicaid drug rebate statute, the Veterans Health Care Act’s drug pricing standards, the federal anti-kickback statute, and other state and federal laws relating to the promotion of prescription drugs and medical devices. In this area, he has assisted with day-to-day methodological counseling, contract pricing strategies, recalculation matters, government pricing investigations, and due diligence on government pricing matters. In addition, Mr. Metro regularly works with manufacturers on health care fraud and abuse compliance, including regulatory, transactional and litigation matters. He has helped companies in various aspects of compliance program development and financial relationship reporting, as well as day-to-day counseling, the preparation of OIG advisory opinion requests, responses to subpoenas and other internal and external investigations and conducting health care regulatory due diligence in the context of product and company acquisitions.
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This 90-minute webinar is eligible in most states for 1.5 CLE credits.
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Date + Time
- event
Thursday, July 23, 2026
- schedule
1:00 PM ET/10:00 AM PT
I. Introduction
II. New HHS-OIG guidance
A. Purpose
B. Overview of AKS
C. When manufacturers' DTC prescription drug sales to federal healthcare program enrollees may violate AKS
D. DTC program characteristics presenting a low risk of AKS violation
III. Congressional pushback: the Durbin/Warren/Welch letter and TrumpRx
IV. Unanswered questions and ongoing risks for stakeholders
V. Best practices for compliance
VI. Key takeaways
The panel will review these and other important considerations:
- What is the history and scope of the guidance?
- What characteristics in a manufacturer's DTC prescription drug program may present a low risk of AKS violation per HHS-OIG?
- What significant questions and risks remain for covered stakeholders? How does the Durbin/Warren/Welch letter draw attention to some of these concerns?
- What are best practices for compliance for covered stakeholders?
Related Courses
New HHS-OIG Guidance: Mitigating AKS Risks in Direct-to-Consumer Prescription Drug Sales to Federal Healthcare Enrollees
Thursday, July 23, 2026
1:00 PM ET/10:00 AM PT
