On June 29, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-14, approving in part, and denying in part, a request from an ophthalmology practice (Requestor) regarding four variations of its proposed continuing education (CE) programs designed for local optometrists (Proposed Arrangements).
This partially favorable and largely unfavorable opinion is noteworthy because it reinforces OIG’s concerns with free CE programs, applies recent OIG guidance related to speaker programs funded by pharmaceutical and device manufacturers to programs organized by physicians, and leaves some confusion around the impact of fair market value (FMV) payments for CE.
Requestor is an ophthalmology practice specializing in cataract and refractive surgery, comprised of one ophthalmologist and three optometrists. Requestor receives half of its surgical referrals from local optometrists, and 30 percent of those patients return to the referring optometrist for post-operative care co-managed by Requestor’s ophthalmologist. Co-management between ophthalmologists and referring optometrists is permitted under the Medicare billing rules, with certain conditions.
Requestor proposed to offer two CE programs annually to local optometrists, designed to address new technology and pharmaceutical practice treatment protocols related to patients treated with ophthalmic surgeries. Requestor would seek approval from relevant accreditation bodies to offer optometrists CE credits towards their annual CE requirements.
Requestor would structure the payment for these CE programs in one of four ways:
- Under Proposed Arrangement A, Requestor would charge attendees an FMV registration fee to attend the CE programs.
- Under Proposed Arrangement B, Requestor would not charge any registration fee and would cover the entire cost of the programs alone.
- Under Proposed Arrangement C, Requestor would not charge any registration fee and would solicit funding from industry sponsors, such as pharmaceutical and device manufacturers, to offset some or all of the programs’ costs.
- Under Proposed Arrangement D, Requestor would charge a registration fee but would subsidize some portion of the fee using funding from industry sponsors, such as pharmaceutical and device manufacturers.
- In the case of Proposed Arrangements A, C, and D, Requestor would absorb any program budget shortfalls and donate any surpluses to disinterested charities.
In all Proposed Arrangements, the CE programs would be open to all local optometrists, regardless of historical or anticipated referral patterns, include modest food and non-alcoholic refreshments, and consist of faculty from Requestor’s practice. Full-day events may also include university faculty, who would not be chosen based on referral patterns and would be paid an FMV honorarium plus expenses. For industry-sponsored events, attendees and faculty would also not be selected based on ordering patterns with respect to a sponsor’s items or services.
OIG concluded that each of the Proposed Arrangements implicates the federal Anti-Kickback Statute, 42 U.S.C. 1320a-7b(b), (the AKS) because, “under each, Requestor would give something of value (the CE programs) to local optometrists who are positioned to refer patients, including [f]ederal health care program beneficiaries, to Requestor for surgery.” Additionally, OIG concluded that Proposed Arrangements C and D involve remuneration to Requestor, external faculty, and attendees from manufacturers that may receive orders from those parties.
OIG nevertheless concluded that only Proposed Arrangement A—under which attendees would pay FMV fees to attend the CE programs—would present no more than a minimal risk under the AKS.
OIG began its analysis by highlighting its enforcement history related to speaker programs sponsored by pharmaceutical and device manufacturers and the related issuance of its November 2020 Special Fraud Alert for Speaker Programs (the SFA). OIG stated that the SFA is instructive here, even though Requestor is not a manufacturer and, in half of the Proposed Arrangements, no manufacturer would sponsor or otherwise participate in any aspect of the CE programs. OIG focused on five key concerns from the SFA when analyzing Requestor’s CE programs, ultimately concluding that the CE programs did not exhibit the suspect characteristics:
- SFA Concern: A company sponsors a speaker program where little or no substantive information is presented.
- OIG Finding: Requestor’s CE content involves new technology and protocols, and faculty possess first-hand experience and expertise on these topics. Further, the CE programs would be approved for credit by accreditation boards.
- SFA Concern: Alcohol is available, or a meal exceeding modest value is provided to attendees.
- OIG Finding: Requestor provides only modest food and non-alcoholic beverages such as bagels, coffee, and pizza.
- SFA Concern: The program is held at a location not conducive to exchanging educational information.
- OIG Finding: Requestor’s venue is scaled to an appropriate size conducive to educational presentations and is not held in conjunction with sporting or recreational events.
- SFA Concern: Selection of speakers or attendees is based on past or expected revenue that these individuals generate by prescribing or ordering the company’s products.
- OIG Finding: The CE programs would be open to all local optometrists; Optometrists would not be required to refer patients to Requestor to attend. Requestor would not select attendees or external faculty based on their referrals to Requestor or their past or anticipated prescribing or ordering of any industry sponsor’s items or services.
- SFA Concern: A company pays speakers more than FMV for speaking or pays compensation that takes into account the volume or value of the speakers’ past or potential future business.
- OIG Finding: External faculty would be paid an FMV honorarium plus expenses, and the payments would not take into account the volume or value of past or potential future business generated for Requestor or any industry sponsor by any faculty presenter.
While OIG’s analysis regarding the SFA applies to all four Proposed Arrangements, OIG reached different conclusions regarding the risk of fraud and abuse the Proposed Arrangements posed. OIG first concluded that Proposed Arrangement A, where Requestor would charge an FMV fee to attend and which involved no industry sponsors, would implicate the AKS but posed a sufficiently low risk of fraud and abuse to warrant a favorable opinion.
Conversely, OIG concluded that Requestor’s funding of the CE programs (with or without outside sponsorships) under Proposed Arrangements B and C presented too high of a risk to approve because the free CE could induce attendees and faculty to refer surgical patients to Requestor. OIG also concluded that the medical device and pharmaceutical companies’ sponsorships could induce Requestor, external faculty, and the optometrist attendees to prescribe or order the sponsoring companies’ products. OIG thus concluded that Proposed Arrangements B and C would pose more than minimal risk of fraud and abuse.
In its analysis of Proposed Arrangement D, where Requestor would use funding from industry sponsors to subsidize some portion of the registration fee, OIG did not address the risk of fraud and abuse posed by the attendees’ registration payments to Requestor. Rather, OIG focused on the industry sponsorships, stating in a footnote that Requestor would pass the industry sponsorships it receives through to attendees (by subsidizing part of their registration fees) and to the external faculty (by partially or fully funding their honoraria and expenses). OIG distinguished Proposed Arrangement D from “the types of problematic scenarios involving rewards for high-prescribing or ordering physicians” but was unable to conclude that the industry sponsorships in Proposed Arrangement D were low risk because the manufacturer-sponsors may pay expenses that Requestor otherwise would incur.
Advisory Opinion 22-14 reflects the well-established position that the provision of free or below-FMV goods or services, including in the form of CE programs, to existing or potential referral sources implicates the AKS. The advisory opinion also is noteworthy because OIG applied the SFA analytical framework to healthcare providers, not just the pharmaceutical and medical device companies specifically addressed in the SFA.
Just as important is what Advisory Opinion 22-14 does not say about FMV exchanges between referral sources.
For instance, OIG often points to a safe harbor that might apply and explains why an arrangement that may not satisfy one or more of the safe harbor’s requirements nonetheless poses a low risk of fraud and abuse. In its analysis of Proposed Arrangement A, however, OIG does not mention the personal services and management contracts safe harbor, even though the Proposed Arrangement appears to satisfy all of that safe harbor’s requirements except for the one-year-term requirement.
Additionally, although OIG has always taken the position that even FMV payments for items or services can implicate the AKS, OIG does not explain why it believes that Requestor’s proposal to charge local optometrists an FMV fee for a commercially reasonable and necessary service they may obtain elsewhere is remuneration to the optometrists that is designed to induce them to refer patients to Requestor. Instead, OIG concludes that Proposed Arrangement A is low risk based on the FMV nature of the transaction and the other “low-risk aspects of the CE programs” it highlighted in its analysis of the Proposed Arrangements under the SFA. In addition, although OIG cites its concern that Requestor’s potential expenses may exceed the FMV registration fees it collects, OIG does not explain how or why that concern relates to whether the FMV registration fees are an inducement to refer.
OIG engages in a slightly more fulsome analysis of Proposed Arrangements B and C, reiterating its long-standing concern with providing free services that have independent value to recipients for which the recipient otherwise would pay and stating that such free or below-FMV CE could induce referrals and result in inappropriate steering. Finally, OIG omits any analysis of the subsidized registration fee attendees would pay in its analysis of Proposed Arrangement D, focusing instead on the remuneration from manufacturers to Requestor. As a result of these omissions, the reader is left to wonder to what extent the FMV nature of the payment may mitigate the risk that an exchange between parties in a position to refer constitutes an inducement.
Although advisory opinions apply only to the requestors, OIG seems to imply in Advisory Opinion 22-14 that any CE program hosted by a referral recipient and attended by referral sources implicates the AKS, even if attendees pay the same FMV registration fee, they would have paid to a third-party host. Entities should structure CE programs with these principles in mind.
Please contact the authors if you have any questions about how this latest advisory opinion may impact your business.
In addition, Bass, Berry & Sims attorneys Jennifer Michael and Stewart Kameen authored an article on this topic, “OIG Advisory Opinion 22-14: What OIG’s Analysis Leaves Unsaid, and What it Means for the Future of Continuing Education Programs,” for the American Health Law Association (AHLA). The content was published on August 11 as part of the AHLA’s Fraud and Abuse Practice Group and is available online (subscription required). Jennifer was also interviewed on the AHLA Speaking of Health Law podcast about Advisory Opinion 22-14. Details about that interview are available here.