On
While the alert is focused on the conduct and liability of the “bigger fish” - the drug and device companies holding and organizing such speaker programs - it is important to keep in mind that the Anti-Kickback Statute (AKS) likewise holds HCPs, including prescribers, accountable for receiving any remuneration in connection with what is determined to be a “sham” speaker program intended to induce orders or referrals, whether in the capacity of an attendee or a speaker. Indeed, the AKS is a two-way street, and it is a criminal offense for an HCP to knowingly and willfully receive remuneration intended to induce or reward referrals or orders for items or services reimbursed by a Federal Health Care Program. Further, in addition to drug and device manufacturers, other industry stakeholders that engage HCPs for such speaking engagements such as specialty pharmacies and GPOs should heed the warning of the alert as well.
Recent Enforcement Related to Speaker Programs
Recent enforcement actions regarding HCPs involvement in sham speaker programs have gained traction in 2020 and put into context the application of OIG's recent alert. Earlier this year, a
While the case involving
Takeaways for Compliant Speaker Programs
To protect themselves, HCPs should accept invitations to present or attend speaker programs with a skeptical view akin to that which the OIG has seemingly adopted for scrutinizing the conduct of drug and device manufacturers, including pharmacies. HCPs should be alert to speaker program invitations that are reminiscent of OIG's list of “suspect” speaker program characteristics to minimize their liability. Drug and device manufacturers should in turn keep this list in mind when structuring and organizing speaker programs, or when entering into such speaker program arrangements with prescribers. Without limitations, drug and device manufacturers, specialty pharmacies, HCPs, and other actors in the healthcare eco-system should be mindful of:
- Organizing, or being invited to, the same or substantially same program despite a lack of any new medical or scientific information.
- Educational events with the option to invite non-HCPs such as staff, friends, or significant others that have no legitimate business reason for attending such events.
- Events at venues not conducive to educational sessions, such as busy restaurants, sports, and entertainment events.
- Higher than fair market value speaking fees that take into account the volume or value of business generated or potential future business generated by the HCP.
In sum, viewing the OIG's Special Fraud Alert as an indication of OIG's renewed focus on sham speaker programs, the healthcare industry should carefully assess financial relationships between manufacturers and HCPs, and be wary of anything that could be perceived as “lavish” or “extravagant” in connection to speaker programs. If the offer is too good to be true, it probably is.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
Mr
Bass, Berry & Sims
1201 Pennsylvania
Avenue NW
Suite 300
37201
DC 20004
© Mondaq Ltd, 2020 - Tel. +44 (0)20 8544 8300 - http://www.mondaq.com, source