BIG Advisory for the Healthcare Industry August 2022
Advisory Opinion 22-16, Published 19 August 2022
The applicant operates a shared decision-making e-learning tool that educates patients about the potential risks, benefits, and expectations of surgeries. The program consists of two modules, each with three components. The first module aims to help patients understand their diagnosis (or diagnoses) and explain their symptoms, educate patients on how to discuss their diagnosis (or diagnoses) with their primary care providers, and educate patients about non-surgical treatment options. The second module is for patients choosing a surgical treatment option and is designed to educate patients about the different types of surgical facilities that exist (eg, hospitals and outpatient surgery centers); help patients prepare for surgery by, for example, creating a list of things to do before the operation; and reduce the risk of complications and facilitate recovery by providing information on postoperative care. The content of the program is tailored to the individual user. The program does not contain any information about particular vendors, practitioners, vendors or services. Instead, the program asks patients to contact their primary care provider for additional information.
Applicant contracts with certain Medicare Advantage Organizations (MAOs) to offer the program to individuals enrolled in their Medicare Advantage (MAO) plans, and bills each MAO on a monthly per member basis for its services. Registrants who complete the first module of the program, as well as a survey, receive a $25 gift card at a retailer. Gift cards can be for a big box store or an online retailer that sells a wide variety of items. Although registrants may use the program multiple times during their enrollment period, each registrant may only receive one $25 gift card per year. Applicant performs regular audits to ensure that each eligible registrant receives only one gift card within a single one-year period. The gift card is not dependent on the enrollee undergoing surgery, pursuing a non-surgical treatment option, receiving additional treatment, or demonstrating knowledge of surgery upon investigation, and the program does not reference or recommends any provider, practitioner, supplier or service. Use of the Program by Registrants is voluntary and any Registrant may use the Program and earn a Gift Card as part of the Arrangement.
Applicant has certified that it does not advertise, market or promote the Program or Arrangement to non-Registered Persons. The standard contract governing the arrangement between the applicant and each AAM prohibits the AAM from including information about the gift cards offered under the arrangement in AAM’s marketing communications to prospective applicants.
The OIG concluded that the arrangement implicated the AKS because the $25 gift card that the plaintiff provides to enrollees, each of whom is a beneficiary of the federal health care program, is compensation that could induce enrollees to refer themselves to a particular MA plan offered by an MAO that arranges for the provision of federally reimbursable items or services. Gift cards are also a cash equivalent, as they are for a big box store or an online retailer that sells a wide variety of items. However, the OIG concluded that the arrangement presented a low risk of fraud and abuse under the AKS for the following reasons:
- The arrangement is unlikely to increase the costs of federal health care programs or result in inappropriate use, and could have the opposite effect.
- The likelihood that the arrangement will significantly influence a beneficiary’s choice of a particular SA plan is low because the applicant does not advertise the program or arrangement to beneficiaries who are not enrolled, and the Applicant’s standard contract with AAMs prohibits AAM from including information about the gift cards offered under the Arrangement in AAM’s marketing communications to enrollees.
- The Arrangement is unlikely to impact competition among healthcare providers, practitioners or suppliers.
For these reasons, the OIG has stated that it will not impose administrative penalties on the claimant under the AKS in connection with the arrangement.
The OIG also concluded that while the arrangement is clearly compensation for a beneficiary of the Medicare program, the arrangement does not implicate the civil monetary penalty provision of the Social Security Act prohibiting inducements to beneficiaries ( incentives to CMP beneficiaries). The OIG noted that when evaluating an arrangement under the CMP for Recipient Incentives, it considers whether the applicant would know or have reason to know that the compensation it provides to recipients is likely to influence their selection of a particular provider, practitioner or supplier for the order. or the receipt of any item or service for which payment may be made, in whole or in part, by Medicare or a state health care program. Remuneration for registrants under the arrangement (i.e. gift card) is paid upon completion of the first module of the program. The OIG determined that since the program does not name or endorse any provider, practitioner, vendor, or service, the compensation paid to enrollees is not likely to influence the selection of any provider, practitioner, or service. a particular provider. To the extent that the Program has the potential to influence a recipient’s choice of a particular MA Plan, the OIG noted that an MA Plan is not a Provider, Practitioner, or Supplier for the purposes of incentives to CMP recipients.