In the last sentence of the Special Fraud Alert, the IGO invites producers and HCPs to seek further guidance on specific agreements by providing an opinion to the IHO. By filing a request for an opinion, a manufacturer can confirm the compliance status of its speaker programs. Given the uncertainty resulting from the new guidelines for specific fraud warnings, manufacturers may seek more clarity by requesting an opinion in order to obtain greater security in the event of a change in their speaker operations. Note that favorable expertise would also help protect a manufacturer from possible whistleblower allegations. The Special Fraud Alert contains a list of features of the spokesperson program that LIG considers to be an increased risk of AAA. AKS makes it illegal, in a relevant part, to pay or obtain remuneration for the purchase, use, prescription or transfer of a product or service paid for in whole or in part by a federal health program. [i] The list is based on allegations made in cases investigated by oIG and the Department of Justice (DOJ) in recent years. The list of suspicious or risk attributes of OIG should be illustrative and not exhaustive, as follows:[ii] A special fraud warning issued by the U.S. Dept. Of Health and Human Services, Office of Inspector General (OIG or the Office) was published on 16 November 2020, advising pharmaceutical and medical device companies to exercise caution in implementing spokesperson programmes. The Special Fraud Alert, OIG`s first in more than six years, warns manufacturers and healthcare professionals (HCPs) against the activities of the spokesperson program.
In the warning, OIG classifies spokesperson programs as “inherently risky” and expresses skepticism about their pedagogical value, especially when programs are implemented in circumstances less conducive to learning. OIG provides a non-exhaustive list of features that pose a higher risk for a spokesperson program agreement to violate the Federal Health Program`s Anti-Kickback (“AKS”) Law. . . .