On August 19, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-16 (Advisory Opinion) in which it declined to impose sanctions for an arrangement under which the requestor provides gift cards to patients for completing an online learning program related to surgeries. The OIG concluded that although the arrangement would constitute prohibited remuneration under the federal anti-kickback statute (AKS) and the beneficiary inducement prohibitions of the Civil Monetary Penalties Law (CMP), it is unlikely to impact competition among providers or influence selection of a particular provider and therefore determined that the arrangement did not warrant the imposition of sanctions.
The requestor (Requestor) operates an online learning tool (Learning Tool) to educate patients on risks, benefits, and expectations related to surgeries . Among other things, the Learning Tool educates patients on their respective diagnoses, non-surgical treatment options, and for those patients that choose to have surgery, the Learning Tool provides information to help patients reduce post-surgery complications. In a footnote, the OIG notes that the Requestor is a recipient of a Health Care Innovation Award, and as part of the award, CMS reviewed the Learning Tool and found that it was associated with a statistically significant decrease in some surgical utilization and cost measures. The Requestor enters into agreements with Medicare Advantage Organizations (MAOs) to offer the Learning Tool to their Medicare Advantage (MA) enrollees. Requestor charges the MAOs on a per-enrollee, per-month basis. Notably, the agreements between the Requestor and the MAOs prohibit the MAOs from including information related to Requestor’s gift cards in the MAOs’ marketing materials.
Under the arrangement, Medicare Advantage enrollees receive a $25 gift card to a retailer for completing the first Learning Tool module and a survey. Enrollees have options to choose various retailers from whom to receive a gift card, however, each available retailer sells a wide-variety of items. Use of the Learning Tool is voluntary and open to all of an MAO’s enrollees. Requestor’s provision of the gift card is not contingent on the enrollee undergoing surgery, receiving non-surgical treatment, or receiving any other treatment. Patients are eligible for only one gift card annually, regardless of how many times they complete the Learning Tool or survey. According to the Advisory Opinion, the Requestor performs regular audits to ensure that enrollees remain eligible and are not provided with more than one gift card per year.
The AKS is a criminal statute that prohibits knowingly and willfully offering, paying, soliciting and receiving “remuneration” (whether monetary or in-kind) in exchange for the inducement, or in return for, referrals of items or services reimbursable by a federal health care program. The beneficiary inducement component of the CMP prohibits offering money or services that are likely to influence a federal health care program beneficiary to select a particular health care provider.
According to the OIG, the arrangement implicates the AKS, but not the beneficiary inducement prohibition of the CMP. The AKS is implicated because providing gift cards to patients is remuneration that could induce a patient to self-refer to, or select, a particular Medicare Advantage plan offered by an MAO, which arranges for the provision of items and services that are reimbursable by federally-funded health care programs. Furthermore, the OIG notes that the gift cards are cash equivalents, which the OIG generally disfavors and noted in its 2020 rulemaking are not subject to safe harbor protection, unless certain limitations apply, which are not present in this arrangement. However, the OIG determined that the arrangement presented a low risk of fraud and abuse and decided not impose sanctions against the Requestor.
The OIG identified the following safeguards in the arrangement that led it to conclude there is a low risk of fraud and abuse:
- Because the Learning Tool is designed to educate enrollees about diagnoses, post-surgical care, and surgical alternatives, the arrangement was unlikely to increase costs to federal health care programs or result in inappropriate utilization. Instead, the OIG noted the possibility that the arrangement could reduce costs and utilization.
- The arrangement is unlikely to influence an individual’s choice of an MAO or MA plan because the value of the gift cards provided to enrollees is modest and the arrangement is only advertised to individuals who are enrolled with a participating MAO. The OIG also cited the contractual prohibition preventing MAOs from advertising the arrangement. Because the gift card can be provided annually, the OIG did address the potential that the arrangement could influence an enrollee to re-enroll with an MAO that participates in the arrangement over a non-participating MAO. The OIG determined that other factors, such as premiums, benefits, and the MAO’s provider network, are much more influential when it comes to re-enrollment decisions.
- The arrangement does not refer to, recommend, or include any information about particular providers, practitioners, suppliers or services. Notably, the OIG pointed out that the Medicare Advantage plans offered by the MAOs are not providers, practitioners, or suppliers for purposes of the beneficiary inducement CMP.
With respect to the beneficiary inducement CMP, the OIG determined that although the gift cards are clearly remuneration provided to beneficiaries, because the Learning Tool does not refer to or recommend any provider, supplier, practitioner, or service, it is therefore unlikely to influence an enrollee’s selection of a particular provider, supplier, or practitioner. The OIG further explained that even if the arrangement influenced a beneficiary’s selection of an MA plan, the arrangement would not run afoul of the beneficiary inducement CMP because MA plans are not providers, practitioners, or suppliers under the CMP.
The OIG’s Advisory Opinion builds upon other recent OIG advisory opinions addressing gift cards (e.g., Advisory Opinion 20-08 and Advisory Opinion 22-04) and provides the health care community with additional insight into the OIG’s view of safeguards to incorporate into innovative programs designed to educate patients.
As the OIG has emphasized, its Advisory Opinions are issued only to the requestors of the opinion, and have no application to, and cannot be relied upon by, any individual or entity, nor may they be introduced into evidence by anyone other than the requestors to prove the individual or entity did not violate the anti-kickback statute or any other law.