The Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently issued OIG Advisory Opinion No. 22-14 that applied its November 2020 special fraud alert targeting remuneration associated with speaking arrangements funded by pharmaceutical and medical device companies.
The November 2020 special fraud alert addressed potential Anti-Kickback Statute (AKS) risks arising from paying physicians to speak at educational programs and providing benefits to attendees. OIG outlined several factors that, if present, would increase the risk of an AKS violation.
OIG’s No. 22-14 Advisory Opinion was issued in response to an ophthalmology practice’s proposed continued education program. The practice intended to offer continued education programs to local optometrists, who may be responsible for referring approximately half of the practice’s surgical patients. Although many of the local optometrists refer their patients to the practice, the program would be available to all optometrists in the area, and there would be no obligation to refer patients to the practice after attending the program.
The program would provide education on new technology and pharmacological practice treatment protocols relevant to treating patients who undergo ophthalmic surgeries, including the practice’s patients. The practice’s own ophthalmologists and optometrists would serve as faculty for the program and would present the information either at a rental venue, its office, or virtually and if in-person, would provide light food and non-alcoholic beverages.
The practice provided four proposed financing options to cover the costs of the program, all of which included the practice paying for any expense shortfalls and donating any windfall. Option A would involve attendees bearing the cost of the program, where each attendee would be charged a registration fee that is “consistent with fair market value” for similar continued education programs. Alternatively, Option B would find the practice covering the entire cost of the program. Option C would similarly involve no attendance fee, but instead, the cost would be covered by industry sponsors (eg. medical device or pharmaceutical companies). Finally, Option D is a combination of Options A and C where the attendance fee would be partially subsidized by an industry sponsor’s contribution.
OIG analyzed the proposed program and financing options and determined that they implicated the AKS because the practice would be giving something of value (the program) to attendees who are in a position to refer their patients to the practice. OIG also noted that Options C and D add additional remuneration to the practice and attendees in the form of industry sponsorship from companies that may receive orders from the practice and attendees in the future.
In its analysis, OIG acknowledged that continued education programs are an important tool for sharing new techniques, skills, and information amongst healthcare providers, and that continued education programs generally do not exhibit suspect characteristics included in the original risk factors. OIG found that financing Option A would pose a sufficiently low risk for AKS violation such that it would not seek to impose administrative sanctions because the attendees covered their own expenses and no industry sponsors would be involved. Alternatively, the options that covered all of the attendees’ fees (Options B and C) would create a more than minimal risk of AKS violation and could potentially lead to administrative sanctions. In short, providing the continued education program for free would create a higher risk of inappropriate patient steering by the attendees. Finally, OIG found that Option D also posed a less than minimal risk of AKS violation because of the industry sponsor involvement, but also acknowledged that it is commonplace for industry sponsorship to subsidize parts of attendance fees.
In conclusion, OIG identified that all of the proposed financing options would generate prohibited remuneration under AKS, but would not impose sanctions for Option A. Further, the risk for AKS violation and administrative sanction increased when no attendance fees were charged and industry sponsors became involved.
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 wapc@wachler.com