On September 29, the U.S. Department of Health and Human Services Office of Inspector General issued a favorable advisory opinion regarding the proposed subsidization of certain Medicare cost-sharing obligations relating to a clinical study of Alzheimer’s disease.

The requestor is a professional medical society that represents radiologists and a charity that provides support and research relating to Alzheimer’s. The unnamed professional association sponsors the study, which is designed to evaluate the association between certain brain imaging procedures and patient outcomes in a racially and clinically diverse group of Medicare participants who are experiencing cognitive impairment.

The study involves the use of a PET scan of the brain to detect beta amyloid plaques. In people with Alzheimer’s, abnormal levels of this naturally occurring protein clump together to form plaques that collect between neurons and disrupt cell function. The study is limited to Medicare beneficiaries. Those deemed eligible to participate must meet certain enrollment criteria.

The requestor hopes to enroll approximately 350 sites, each of which must be a hospital outpatient department or an independent diagnostic facility at which these scans will be performed. To participate physicians must be vetted based on a specific set of criteria. The aim is to include about 7,000 people, 4,000 of which would be minorities.

The requestor will compensate the physicians for services provided as part of the study at fair market value. In addition, requestors would pay the sites director for the co-insurance that Medicare beneficiaries participating in the study would otherwise owe. The funding would come from the charity, which is funded by individuals and foundations. None of these donations would come from entities with a financial interest in the study, such as manufacturers of the imaging agents used in the PET scans.

In addition, the funding and administration of the coinsurance subsidies would not further the commercial interests of the requestors because the study is not intended to develop, study, or benefit any commercial product sold or marketed by the requestors.

The requestors state that minority communities might not be able to enroll in this study because, in many cases, they lack the financial resources to pay the co-insurance. The availability of coinsurance payments would not be advertised, rather those selected for the study would be told of its availability as part of the informed consent process.

In its opinion, the OIG noted that the coinsurance subsidies offered under the proposed arrangement appear to be a reasonable way to facilitate enrollment of a diverse set of subjects by removing a potential financial barrier to participation in the study.

Furthermore, the arrangement would pose a low risk of overutilization or inappropriate utilization of federal healthcare program items and services. “Indeed, the proposed arrangement would include various guardrails to mitigate the risk of inappropriate utilization or an improper increase in costs to federal healthcare programs,” the OIG states in its opinion.

Finally, the OIG noted that the arrangement is distinguishable from “problematic seeding arrangements, such as those in which manufacturers offer subsidies initially to lock in future reimbursable utilization of an item or service.”

Based on the facts specific to this arrangement, the OIG gave its blessing to the arrangement.

It’s important to note that each arrangement is different, and the opinions are limited to the specifics in each individual request. However, the OIG always reserves the right to reconsider the question and can, as it has in the past, rescinded opinions.

If your healthcare organization is considering entering into a proposed arrangement of any kind, it’s always best to check with legal counsel to ensure it does not violate the anti-kickback statutes, False Claims Act or other laws regulating such arrangements.

The Health Law Offices of Anthony C. Vitale can assist you in making these decisions. For more information contact us at 305-358-4500 or email info@vitalehealthlaw.com.