Earlier this month, OIG issued a Special Fraud Alert on Speaker Programs warning drug and device companies and health care providers that it has significant concerns about payments for “speaker programs.” Based on recent investigations and enforcement activity, the OIG has found that a number of speaker programs sponsored by drug and device manufacturers violate the federal Anti-Kickback Statute (AKS). OIG is skeptical about the educational value of speaker programs provided under circumstances that are not conducive to learning and to audience members who have no legitimate reason to attend. Additionally, OIG questions the value of such events given that health care providers can access the same or similar information online, on the product’s package insert, third-party educational conferences, medical journals, and more. Because all of this material is already available, OIG warns “that at least one purpose of remuneration associated with speaker programs is often to induce or reward referrals” in violation of the federal Anti-Kickback Statute (AKS).

OIG defined speaker programs as drug or device “company-sponsored events at which a [outside] physician or other health care professional (collectively, “HCP”) makes a speech or presentation to other [outside] HCPs about a drug or device product or a disease state on behalf of the company” using a presentation developed and approved by the company. HCPs are paid an honorarium and attendees are paid generally through free meals and drinks, for example.

Based on its investigations to date, OIG provided an illustrative list of speaker program characteristics that result in higher level of scrutiny with respect to AKS violations:

  • Little or no substantive information is actually presented by the speaker;
  • Alcohol (especially if for free) or a meal exceeding modest value is provided;
  • Environment is not conducive to the exchange of educational information (e.g., restaurants or entertainment or sports venues);
  • Large number of speaker programs sponsored on the same or substantially the same topic or product (especially if no recent substantive change in relevant information or applicable law/regulation) and repeat attendees or attendees are past speaker on the same or substantially the same topic;
  • Attendees without a legitimate business reason or use for the information attend the program;
  • HCP speakers or attendees selected based on past or on expected revenue from prescribing or ordering the company’s product(s) (e.g., a return on investment analysis is considered in identifying participants);
  • Higher than fair market value honorarium paid for the speaking service or compensation that takes into account the volume or value of past business generated or potential future business generated by the HCPs.

In light of the COVID-19 pandemic, OIG recognizes that the speaker activity may have slowed. But OIG fully anticipates that once in person meetings are back in full swing, it will be paying attention to any drug or device company that organizes or pays remuneration associated with the program, any HCP who is paid to speak, and any HCP attendees who receive remuneration from the company (e.g., free food and drink).

The OIG acknowledged that speaker programs sponsored by manufacturers are not per se illegal.  Yet, this alert is a warning to all manufacturers that they should scrutinize their speaker programs to ensure that they serve a legitimate purpose and avoid the areas of warning from the OIG.  This Alert is also notable, in that the OIG not only used experience from their enforcement actions to inform this statement, they also used data from CMS’s Open Payments program that requires reporting of financial relationship data between manufacturers and physicians and academic medical centers.  It will be interesting to see if the OIG continues to mine this financial data to provide additional alerts in the future.  Finally, while the OIG has not focused on speaker programs sponsored by other healthcare providers like durable medical equipment suppliers or laboratories, the same warnings in this fraud alert can apply. Therefore, all providers should evaluate their speaker programs to mitigate risks that are raised under the AKS.

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Photo of Troy A. Barsky Troy A. Barsky

Troy Barsky is a partner in Crowell & Moring’s Washington, D.C. office, and serves as a member of the firm’s Health Care Group Steering Committee where he focuses on health care fraud and abuse, and Medicare and Medicaid law and policy. Troy counsels…

Troy Barsky is a partner in Crowell & Moring’s Washington, D.C. office, and serves as a member of the firm’s Health Care Group Steering Committee where he focuses on health care fraud and abuse, and Medicare and Medicaid law and policy. Troy counsels all types of health care entities, including hospitals, group practices, and health plans on the physician self-referral law (Stark Law) and the Anti-Kickback Statute, innovative healthcare delivery models, such as Accountable Care Organizations (ACOs), and Medicare & Medicaid payment and coverage policy. He also defends clients seeking resolution of government health care program overpayment issues or fraud and abuse matters through self-disclosures and negotiated settlements with the U.S. Department of Justice, U.S. Health & Human Services Office of the Inspector General and the Centers for Medicare & Medicaid Services (CMS).

Photo of Michael Shaheen Michael Shaheen

Michael Shaheen is a partner in the White Collar & Regulatory Enforcement and Health Care groups in the Washington, D.C. office of Crowell & Moring. His practice focuses on federal litigation, investigations, and enforcement actions. Michael has significant experience with the False Claims…

Michael Shaheen is a partner in the White Collar & Regulatory Enforcement and Health Care groups in the Washington, D.C. office of Crowell & Moring. His practice focuses on federal litigation, investigations, and enforcement actions. Michael has significant experience with the False Claims Act (FCA), with particular emphasis on health care fraud.

Before joining Crowell & Moring, Michael served as a Trial Attorney with the Fraud Section of the Department of Justice (DOJ), where his work primarily involved investigating and prosecuting FCA matters. At DOJ, he obtained judgments totaling hundreds of millions of dollars and was involved in the settlement of numerous false claims cases of similar magnitude. Michael served in a variety of roles in these cases, ranging from first-chair trial attorney to lead investigator.

Photo of Lidia Niecko-Najjum Lidia Niecko-Najjum

Lidia Niecko-Najjum is a counsel in Crowell & Moring’s Health Care Group and is part of the firm’s Digital Health Practice. With over 15 years of clinical, policy, and legal experience, Lidia provides strategic advice on health care regulatory and policy matters, with…

Lidia Niecko-Najjum is a counsel in Crowell & Moring’s Health Care Group and is part of the firm’s Digital Health Practice. With over 15 years of clinical, policy, and legal experience, Lidia provides strategic advice on health care regulatory and policy matters, with particular focus on artificial intelligence, machine learning, digital therapeutics, telehealth, interoperability, and privacy and security. Representative clients include health plans, health systems, academic medical centers, digital health companies, and long-term care facilities.

Lidia’s experience includes serving as a senior research and policy analyst at the Association of American Medical Colleges on the Policy, Strategy & Outreach team. Lidia also practiced as a nurse at Georgetown University Hospital in the general medicine with telemetry unit and the GI endoscopy suite, where she assisted with endoscopic procedures and administered conscious sedation.