OIG Advisory Opinion on Continuing Education Provides Insight on Risk Areas
In June 2022, the Office of the Inspector General (OIG) for the US Department of Health and Human Services (HHS) issued Advisory Opinion 22-141 regarding an ophthalmology practice’s (Requestor) proposal to offer two annual continuing education (CE) programs to local optometrists in Requestor’s service area. As outlined below, the Requestor proposed four ways to offer these CE programs to optometrists, including two proposals that would involve a grant from pharmaceutical and medical device manufacturers (Manufacturers). OIG found that all four proposals implicated the Anti-Kickback Statute (AKS) because the subsidized or free CE programs could induce CE program attendees to refer patients to the ophthalmology practice or to Manufacturer products. OIG found that the two proposals that would have included grants from Manufacturers raised more than minimal risks of fraud and abuse because the grants would be given to an entity directly involved in the provision of patient care, which OIG reasoned posed more than a minimal risk under the AKS that healthcare professionals (HCPs) serving as faculty or attending the CE programs would be induced to prescribe a Manufacturer’s product.
Overall, Advisory Opinion 22-14 does not change OIG’s historic position2 that grants by Manufacturers to independent, accredited education providers (e.g., accredited by the Accreditation Council for Continuing Medical Education (ACCME), professional medical societies or organizations, or accredited education departments of hospitals or healthcare institutions) “raise little risk of fraud and abuse”3 when such arrangements are structured to comply with the 2003 OIG Compliance Program Guidance for Pharmaceutical Manufacturers and the 1997 guidance from the US Food and Drug Administration (FDA),4 as well as the ACCME Standards for Independence and Integrity (SII” (f/k/a Standards for Commercial Support).
Brief Overview of the AKS and OIG Guidance on Manufacturer’s and Educational Grants
The OIG starts with its position that the AKS prohibits any person from knowingly and willfully paying remuneration (e.g., a thing of value) to any person with the intent to induce that person to purchase, prescribe, recommend, or refer a person for the furnishing of items or services payable under a federal health care program (FHCP).5 According to OIG, the AKS and the conspiracy statute can reach the payment maker, the payment recipient, and parties involved in furthering the payment, and as a result, financial arrangements among Manufacturers of government reimbursed products, educational providers, and healthcare providers (as learners, attendees, or facilitators) must be reviewed carefully under the law. 6
In 2003, OIG’s Compliance Program Guidance for Pharmaceutical Manufacturers (CPG) recognized that “grants or support for educational activities sponsored and organized by medical professional organizations raise little risk of fraud or abuse, provided that”: (1) “the grant or support is not restricted or conditioned with respect to content or faculty”; and (2) grant funding is not being used to “channel improper remuneration to physicians or others in a position to generate business for the manufacturer or to influence or control the content of the program.”7 And as OIG acknowledged in its June 2022 advisory opinion, “CE programs are a mainstay for physicians and other licensed practitioners to update their technical knowledge and skills and to learn about new or modified diagnostic and treatment options.”
Conversely, the CPG noted that Manufacturer’s providing educational grants to third-parties could implicate the AKS if the funding8 “is conditioned, in whole or in part, on the purchase of product … even if the educational or research purpose is legitimate.”9 OIG also cautioned that Manufacturers with “any influence over the substance of an educational program or the presenter” can present “risk that the educational program may be used for inappropriate marketing purposes.”10 OIG recommended that Manufacturer’s adopt the following controls:
- Grant review and approval decisions, interactions and activities are managed by a medical function (e.g., Medical Affairs) that is “separate … from sales and marketing” to “[e]nsure that grant funding is not inappropriately influenced by sales or marketing motivations and that the educational purposes of the grant are legitimate:”
- Manufacturer medical functions establish “objective criteria for making grants that do not take into account the volume or value of purchases made by, or anticipated from, the grant recipient and that serve to ensure that the funded activities are bona fide;”
- Manufacturers “should have no control over the speaker or content of the educational presentation;” and
- “Compliance with such procedures should be documented and regularly monitored.”11
Advisory Opinion 22-14
In the state where Requestor—an ophthalmology practice—is located, the optometry licensing board requires 30 hours of CE every 2 years to maintain an optometrist license. The Requestor proposed offering two CE programs that would consist of a full-day CE program providing six hours of CE credit12 and an evening CE program providing two hours of CE credit.13 Requestor would seek approval for its CE programs from the Council on Optometric Practitioner Education (COPE) or the state board of optometry. In addition, the Requestor certified to OIG that:
- The CE programs would be open to all optometrists in Requestor’s 20-mile radial area;
- Attendance would not be limited to optometrists who refer to Requestor, and there would be no requirement that attendees refer patients to Requestor as a condition of attendance;
- Attendees would not be based on past or expected prescribing or ordering of any industry sponsor’s items or services payable by FHCPs
- For the full-day and evening programs, Requestor’s ophthalmologist and optometrists would serve as faculty. Additional faculty for the full-day program would include one or two faculty members from professional schools, who would receive honorarium plus expenses at fair market value (FMV).
- The selection of external faculty would not be based on referrals to Requestor or past or expected prescribing or ordering of any industry sponsor’s items or services payable by FHCPs.
- The CE programs would be broadly and publicly advertised in print, online, and via email
Requestor then proposed four ways to finance the CE programs for attendees (Proposed Arrangements):
- Proposed Arrangement A: The Requestor would charge attendees a FMV registration fee with no outside or industry funding or grants. If revenue received from the registration fees exceeded Requestor’s costs to run the CE programs, Requestor would donate the excess revenue to a local charity that does not bill or provide services to FHCPs.
- Proposed Arrangement B: The Requestor would not charge any registration fee and would cover all costs for attendees with no outside funding.
- Proposed Arrangement C: Requestor would not charge any registration fee and the CE programs would be supported by grants from Manufacturers in compliance with the ACCME SII; Requestor would pay any expense shortfalls or donate any excess revenue.
- Proposed Arrangement D: Requestor would charge a registration fee to attendees and the CE programs would be supported by grants from Manufacturers in compliance with the ACCME SII; Requestor would pay any expense shortfalls or donate any excess revenue.
OIG found that the Proposed Arrangements would implicate the AKS because: (1) the Requestor would give something of value (the CE programs) to local optometrists who are positioned to refer patients, including FHCPs, to Requestor for surgery; and (2) the Requestor, external faculty members and attendees—entities that may prescribe or recommend products—would receive remuneration from Manufacturers for such products under Proposed Arrangements C and D. OIG asserted that “CE programs that are educational in nature, … may constitute a vehicle to provide remuneration to referral sources in violation of the Federal anti-kickback statute in some circumstances.”
OIG recognized that CE programs, such as those proposed by the Requestor, are distinct from speaker programs “organized and paid for by” Manufacturers, such as those outlined in OIG’s 2020 Special Fraud Alert: Speaker Programs (SFA). In that SFA, OIG identifies as “suspect characteristics” programs with little or no substantive information presented, meals exceeding modest value with alcohol available for attendees, use of venues not conducive to education, and selection of presenters and attendees based on prescribing behavior. By contrast, the Requestors CE programs:
- Would be accredited by COPE and address new technology and pharmacological practice treatment protocols;
- Faculty would have first-hand professional experience and expertise on such topics;
- Only modest food would be provided and no alcohol;
- The venue would be in Requestor’s office or an appropriate conference room with no associated entertainment or recreational activities; and
- The other safeguards listed above (e.g., programs open to all local optometrists; no selection based on referrals to Requestor or to Manufacturer products; payment at FMV, etc.)
OIG found that Proposed Arrangement A posed a low risk of fraud and abuse, subject to the business rules and safeguards described by the Requestor.
OIG found that Proposed Arrangement B raised more than minimal risks of fraud and abuse citing OIG’s “longstanding concern about the provision of free goods or services to an existing or potential referral source.” OIG concluded that Proposed Arrangement B presented “more than a minimal risk” because the Requestor was subsidizing the optometrists CE, which OIG asserted could “induce the optometrist attendees and external faculty to refer surgical patients, including federal health care program beneficiaries, to Requestor, which could result in inappropriate patient steering.”
OIG found that Proposed Arrangement C raised more than minimal risks of fraud and abuse determining that there was “heightened risk” that a Manufacturer’s grant to the Requestor could “induce Requestor, external faculty, and the optometrist attendees to prescribe or order a sponsoring company’s products, including those payable by Federal health care programs, which could result in inappropriate patient steering or inappropriately increased costs to Federal health care programs.”
OIG found that Proposed Arrangement D raised more than minimal risks of fraud and abuse because Requestor is “an ophthalmology practice and potentially a direct referral source for sponsoring medical device and pharmaceutical companies.” OIG acknowledged that industry funded grants for CE programs are common in the health care industry when the “CE program organizers … often are independent entities not directly involved in the provision of patient care (e.g., a professional organization).” But because the Requestor in this case was a direct referral source of potential Manufacturer grantors (e.g., direct prescribers/users of the Manufacturer products), OIG asserted that the Manufacturer grant could constitute remuneration in respects: (1) it could subsidize an “expense the Requestor otherwise would incur”; and (2) it could enable the Requestor to donate any excess grant funds to a charity.
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This advisory opinion is limited to the facts certified and applicable only to the requestor. Nonetheless, manufacturers and education providers may wish to consider the implications of this advisory opinion for their practices. Please feel free to reach out to your Arnold & Porter contact if you have any questions.
© Arnold & Porter Kaye Scholer LLP 2022 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.
Federal regulations permit OIG to issue advisory opinions to one or more requesting parties about the application of the OIG’s fraud and abuse authorities (e.g., Anti-Kickback Statute) to the party’s existing or proposed business arrangement. The advisory opinion process is voluntary. An OIG advisory opinion is legally binding on OIG and the requesting party or parties Advisory opinions are not binding on any other individual, entity, governmental department or agency.
68 Fed. Reg. 23731, 23738 (May 5, 2003)(emphasis added).
FDA rules and guidance regarding scientific or educational grants are outside the scope of this article. For more information, see FDA Guidance for Industry: “Industry Supported Scientific and Educational Activities (Nov. 1997), 62 Fed. Reg. 64093.
Some cases have interpreted this statute to cover any arrangement in which one purpose of the remuneration is to obtain money for the referral of services or to induce further referrals. United States v. Kats, 871 F.2d 105 (9th Cir. 1989); United States v. Greber, 760 F.2d 68 (3d Cir.), cert. denied, 474 U.S. 988 (1985); see also United States ex rel. Nevyas v. Allergan, no. 2:09-cv-00432 (E.D. Pa.), n.1, ¶5 (citing Greber, 760 F.2d at 69).
OIG, Compliance Policy Guidance (CPG) for Pharmaceutical Manufacturers, 68 Fed. Reg. 23731, 23738 (May 5, 2003)(emphasis added) .
See e.g., Department of Justice, Press Release, Kos Pharmaceuticals to Pay More Than $41 Million to Resolve Kickback and Off-Label Promotion Allegations (Dec. 7, 2010)(resolving allegations that Kos violated the AKS by, among other things, making “ a series of payments to the two doctors or a third party intermediary in the form of ‘sponsorship’ of continuing medical education classes conducted by the doctors and purported speakers’ fees”).
Requestor estimated that current total costs for the full-day program would be $6,000–$9,000. Food provided at the program would include items such as bagels and coffee in the morning and pizza at lunch (estimated to be about $20 per attendee).
Requestor estimated that current total costs for the evening program would be $500–$1,500 (with food items estimated to be $15–$20 per attendee). Depending on the number of attendees, the evening program could be held at one of Requestor’s offices, eliminating the need for an outside venue. Requestor estimates that the cost of an outside venue, if needed, would be $500. The evening program may be held virtually, which would further reduce costs.