November 18, 2020
On November 16, 2020, the Office of Inspector General (OIG) issued a Special Fraud Alert detailing Anti-Kickback Statute violation risks associated with the offer, payment, solicitation or receipt of remuneration relating to speaker programs by pharmaceutical or medical device companies. The OIG considers speaker programs to generally be company-sponsored events at which a health care professional makes a speech or presentation to other health care professionals about a pharmaceutical or medical device company’s product. The companies that organize and pay for programs, providers paid to speak, and the attendees who receive remuneration relating to the speaker programs may be subject to increased scrutiny under the Anti-Kickback Statute.
The OIG describes certain suspect characteristics, which, on their own or taken together, potentially indicate a speaker program could violate the Anti-Kickback Statute. The Anti-Kickback Statute prohibits transferring anything of value to induce or reward purchasing, ordering, or recommending any item or service reimbursable under the Federal health care program. The provided list is illustrative in nature, not exhaustive and the presence or absence of a characteristic is not indicative of whether a specific speaker program arrangement would violate the Anti-Kickback Statute. The listed factors include:
- Programs where little or no substantive information is presented;
- Programs that make alcohol available or provide meals that exceed modest value;
- Programs held in restaurants or entertainment venues;
- Large numbers of programs on the same topic, with no substantive changes in information;
- Programs provided when there has been a significant period of time with no new medical or scientific information or updates;
- Providers attending programs on the same or similar topics more than once;
- Attendees that do not have a legitimate business reason to attend or have no use for the information;
- The speakers or attendees are selected based on expected revenue that will be generated; or
- Speakers are paid more than fair market value.
As evidenced by this Special Fraud Alert, the OIG has significant concerns about remuneration arrangements in connection with speaker programs. Health care professionals and medical device and pharmaceutical companies should evaluate and consider the risks when deciding whether or not to pay, solicit or receive remuneration related to these programs and when possible, utilize other available methods to disseminate information. To read this Special Fraud Alert in its entirety, please visit here.