Regulatory Alert: OIG issues special fraud alert regarding participation in industry-sponsored speaker programs

On Nov. 16, 2020, the Office of Inspector General (OIG) issued a special fraud alert regarding participation in industry-sponsored speaker programs. The alert highlights what the OIG deems the inherent fraud and abuse risks associated with the offer, payment, solicitation or receipt of remuneration related to speaker programs by pharmaceutical and medical device companies. Such programs will undergo intense scrutiny in the future. 

In summary:

• Speaker programs are generally defined as company-sponsored events at which a physician or other healthcare professional (HCP) makes a speech or presentation to other HCPs about a drug or device product or a disease state on behalf of the company.
• The company generally pays the speaker or HCP an honorarium, and often pays remuneration, e.g., free meals, to the attendees. This has equated to nearly $2 billion in payments for speaker- related services over the last three years.
• This data is reported annually by industry and is publicly available for review via the CMS Open Payments website: https://openpaymentsdata.cms.gov/.
• The OIG is skeptical about the educational value of these programs and strongly believes that the purpose of the remuneration to the speaker and attendees is to induce or reward referrals, and may be in violation of the Anti-Kickback Statute.
• The OIG is also highly skeptical of the expensive food and/or drink provided by pharmaceutical or medical device companies to HCPs, whether on-site or off-site, especially those to four- or five-star restaurants.
• The OIG strongly believes that these types of remuneration may skew clinical decision-making in favor of the HCP’s own financial interests and that of the pharmaceutical or medical device company, rather than the patient’s best interests.
• The company, as well as HCPs, may be subject to criminal, civil and administrative enforcement actions.

In 2019, the YNHHS Compliance Committee approved the Interactions with Vendors policy, which prohibits participation in speaker bureaus.

The Office of Privacy and Corporate Compliance (OPCC) will continue to review Conflict of Interest disclosures as well as Open Payments data to ensure clinicians are no longer participating in these speaker programs.

Should you have a question or concern please contact the OPCC at (203) 688-8416 or [email protected]. You may access the OIG Special Fraud Alert here.