On August 19, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-16, approving an online patient education company’s (Requestor) request to provide gift cards to certain Medicare Advantage (MA) enrollees who complete an online patient education program (the Arrangement).
Requestor is a company that operates a “shared decision-making, online learning tool” designed to educate patients on potential risks, benefits, and expectations related to surgeries (the Program). The Program includes two modules, intended to increase patient understanding of surgical treatment options, reduce inappropriate surgeries, and lead to better outcomes when surgery is required. The Program does not refer to, recommend, or even reference specific healthcare providers, suppliers, practitioners or services.
Requestor contracts with certain Medicare Advantage Organizations (MAOs) to offer the Program to the MAOs’ enrollees (Enrollees). Under the Arrangement, Enrollees who complete the first Program module (along with a survey) receive a $25 gift card to a big box store or online retailer. Enrollees may receive only one $25 gift card annually. Use of the Program is voluntary, and Enrollees who complete the first module need not choose a particular treatment option or demonstrate surgical literacy to receive the gift card. Requestor makes the Program available to all Enrollees, regardless of whether they face an immediate decision regarding surgery. Requestor has implemented policies and procedures outlining these guardrails and conducts regular audits to verify compliance with such policies and procedures.
Requestor informs Enrollees of the Program via direct mailing and email communications. Some communications are sent only to Enrollees who are more likely to face a decision about surgery. Requestor does not advertise or promote the Program to non-Enrollees, and the MAOs are not permitted to include information about the gift cards in their marketing materials.
OIG analyzed the Arrangement under both the federal Anti-Kickback Statute (AKS), 42 U.S.C. 1320a-7b(b), and the civil monetary penalty provision prohibiting inducements to beneficiaries (Beneficiary Inducements CMP), 42 U.S.C. 1320a–7a(a)(5). For the reasons described below, OIG concluded that the Arrangement presents a sufficiently low risk of fraud and abuse under the AKS and does not implicate the Beneficiary Inducements CMP.
The Federal Anti-Kickback Statute
OIG stated that the Arrangement implicates the AKS because the $25 gift cards Requestor provides to Enrollees constitute remuneration that could induce the Enrollees to self-refer to a particular MA plan. OIG reiterated its position that gift cards to big-box stores or online retailers that sell a wide variety of items constitute cash equivalents but indicated that the Arrangement is low risk under the AKS for the following reasons:
- The Arrangement is unlikely to increase costs to federal healthcare programs or result in inappropriate utilization – and could potentially have the opposite effect. OIG indicated that because the Program is designed to increase patient understanding, decrease medically inappropriate surgeries, and mitigate post-surgery complications, it may improve patient safety, reduce inappropriate utilization, and potentially decrease federal healthcare program costs.
- The Arrangement is unlikely to meaningfully influence a beneficiary’s selection of a particular MA plan. Requestor does not advertise the Program to beneficiaries who are not Enrollees and prohibits MAOs from including information about the gift cards in their marketing materials to prospective enrollees. Although the Arrangement could potentially influence Enrollees to re-enroll in a MA plan, OIG concluded that other factors are more likely to influence re-enrollment decisions and that the guardrails Requestor implemented (i.e., $25 cap and annual limit) mitigate this risk.
- The Arrangement is unlikely to impact competition among healthcare providers, practitioners, or suppliers. Because the Program does not include, refer to, or recommend any particular provider, practitioner, supplier, or service, it is unlikely to impact competition among providers, practitioners, and suppliers.
The Beneficiary Inducements CMP
OIG noted that, although the $25 gift cards constitute remuneration to Medicare beneficiaries, the Arrangement does not implicate the Beneficiary Inducements CMP because the Program does not refer to, recommend, or even reference any particular provider, practitioner, supplier, or service and therefore does not influence a beneficiary’s selection of a particular provider, practitioner, supplier, or service. OIG further noted that to the extent the remuneration has the potential to influence a beneficiary’s selection of an MA plan, that MA plan is not a provider, practitioner, or supplier for the purposes of the Beneficiary Inducements CMP.
Advisory Opinion 22-16 provides an avenue for MA plans and downstream contractors to educate patients through limited-frequency, modest rewards—including cash equivalents—as long as the entities implement appropriate safeguards and do not reference, refer to, or recommend any specific provider, practitioner, supplier, or service. Although advisory opinions apply only to the particular requestors, OIG seems to imply that online education options structured similarly to the Program do not raise AKS concerns.
If you have any questions about Advisory Opinion 22-16, please contact the authors.