On September 29, 2021, OIG issued Advisory Opinion No. 21-13 analyzing a proposal for a clinical study that would involve subsidizing Medicare beneficiaries’ cost-sharing obligations in connection with a clinical study relating to Alzheimer’s disease. The study aims to investigate the use of a positron emission tomography (PET) scan that detects beta amyloid (Aβ) plaques to examine whether PET Aβ imaging affects health outcomes in a diverse sample of patients who are Medicare beneficiaries. As discussed in further detail below, OIG finds that the proposed subsidy arrangement could generate prohibited remuneration under the Federal Anti-Kickback Statute (AKS) and the beneficiary inducement provision of the civil monetary penalties law, but ultimately determines that it would not impose administrative sanctions because the arrangement presents a low risk of fraud and abuse.

FACTUAL BACKGROUND

The Advisory Opinion was requested by a professional medical society representing radiologists (the Association) and a nonprofit organization that supports Alzheimer’s research (the Charity). The Association would serve as the sponsor of the study and the Charity would be the director of the study. The Association would enroll approximately 350 sites where the PET Aβ scans will be performed. The sites would include hospital outpatient departments and independent diagnostic facilities. All patients participating in the study would be Medicare beneficiaries. The requestors received approval from CMS in April 2020 for the PET Aβ scans conducted in connection with the study to be reimbursed by Medicare pursuant to a National Coverage Determination issued in 2013.

Under the proposed subsidy arrangement, the Association would reimburse sites directly for the coinsurance that a Medicare beneficiary participating in the study would otherwise owe for the PET Aβ scan. The requestors indicated that enrollment from minority communities could be jeopardized due to lack of resources. The requestors also stated that they proposed to subsidize coinsurance for virtually all subjects, regardless of financial need, in order to remove a potential obstacle to general enrollment.

The requestors would finance the subsidies using funds donated to the Charity by individuals and foundations with the purpose of supporting the Charity’s research programs. The requestors certified that funds used to support the study would be kept segregated and that none of the donations would be from entities with a financial interest in the study. The requestors also certified that the subsidies would not be offered as part of any advertisement or solicitation and that the information regarding the subsidies would be included in the informed consent documents provided to subjects.

ANALYSIS

OIG finds that the subsidies could induce Medicare beneficiaries to participate in the study, which involves the provision of federally reimbursable health care items and services. OIG also notes that the arrangement would provide remuneration to investigators and participating sites through the opportunity to bill Medicare for the services related to the study and the guaranteed coinsurance payment. Based on these factors, OIG concludes that the arrangement would generate prohibited remuneration under the AKS, if the requisite intent to induce referrals were present, and would also generate prohibited remuneration under the beneficiary inducement provision of the civil monetary penalties law. OIG nevertheless concludes that the arrangement would present a minimal risk of fraud and abuse and that, in an exercise of discretion, OIG would not impose sanctions on the requestors in connection with the arrangement. OIG cites the following factors in support of this determination:

• The study was developed in consultation with CMS, and the coinsurance subsidy appears to be designed to meet the policy objective of advancing Alzheimer’s treatment, particularly for minorities. The study could potentially address a real or perceived evidence gap on racial and ethnic factors in Alzheimer’s research.

• There is a low risk of overutilization or inappropriate utilization, and there are guardrails to further mitigate this risk, including the fact that investigators will not advertise the availability of subsidies and that beneficiaries must meet certain eligibility criteria.

• The arrangement is distinguishable from problematic “seeding” arrangements—such as those where manufacturers offer subsidies to lock in future utilization—because participants receive only one PET Aβ scan and three office visits, with no expectation of triggering subsequent utilization of services.

The Advisory Opinion is limited in scope to the proposed arrangement and can only be relied upon by the requestor. However, the opinion provides a helpful indication of how OIG might respond to similar requests.

The Advisory Opinion is available here.