On November 16, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a special fraud alert targeting remuneration associated with speaking arrangements paid for by pharmaceutical and medical device companies. The alert addressed both honoraria paid to the speaking physician and benefits provided to attendees, such as meals or alcohol.
OIG has taken the position that the fees paid to speakers and the benefits provided to attendees may constitute unlawful “remuneration” under the Anti-Kickback Statute (AKS) meant to induce or reward referrals. Pursuant to the AKS, it is unlawful to knowingly and willfully solicit, receive, offer, or pay any remuneration to induce or reward, among other things, referrals for, or orders of, items or services reimbursable by a Federal health care program. According to OIG, pharmaceutical and medical device companies paid nearly $2 billion to physicians and health care professionals for speaker-related services in 2017, 2018, and 2019 combined.
OIG clarified that not every physician speaking arrangement violates the AKS and that it does not intend to discourage meaningful training or education. However, OIG outlined several factors that, in OIG’s view, increase the risk that an arrangement could violate the AKS. These factors include:
- The speaker is not an employee of the company and uses a presentation developed and approved by the company.
- The company sponsors speaker programs where little or no substantive information is actually presented or the information presented is easily accessible from other sources.
- The company sponsors a large number of programs on the same or substantially the same topic or product, especially in situations involving no recent substantive change in relevant information.
- There has been a significant period of time with no new medical or scientific nor a new FDA-approved or cleared indication for the product.
- Alcohol is available or a meal exceeding modest value is provided to the attendees of the program. The concern is heightened when the alcohol is free.
- The program is held at a location that is not conducive to the exchange of educational information, such as a restaurant, entertainment, or sports venue.
- Physicians attend programs on the same or substantially the same topics more than once.
- Attendees include individuals who don’t have a legitimate business reason to attend the program, including, for example, friends, significant others, or family members of the speaker or attendees; employees or medical professionals who are members of the speaker’s own medical practice; staff of facilities for which the speaker is a medical director; and other individuals with no use for the information.
- Past or expected revenue from referrals impacts speaker or attendee selection or compensation.
OIG acknowledged that it issued this fraud alert during a global pandemic when few companies are conducting in-person speaking events. OIG encouraged companies and physicians, when in-person speaking events become common again, to re-asses the fraud and abuse risks of and the need for such programs and to consider alternative means for conveying information to health care professionals.
For over 35 years, Wachler & Associates has represented healthcare providers and suppliers nationwide in a variety of health law matters, and our attorneys can assist providers and suppliers in understanding new developments in the Anti-Kickback Statute and Stark Law. If you or your healthcare entity has any questions pertaining to healthcare compliance, please contact an experienced healthcare attorney at 248-544-0888 or firstname.lastname@example.org