Clarity and flexibility with respect to federal fraud and abuse law has been a consistent priority for Food is Medicine (FIM) implementers and advocates. This blog post explores considerations raised by a recent advisory opinion from the U.S. Department of Health and Human Services Office of the Inspector General (OIG). The OIG opinion recognizes the value of FIM as part of clinical care and the need for common sense approaches to scrutinizing FIM arrangements under federal anti-kickback and beneficiary inducements prohibitions.
The FIM Intervention at the Heart of The Inquiry
In response to requester inquiries, one function of the OIG is to issue advisory opinions about the application of certain fraud and abuse enforcement authorities to existing or proposed business arrangements.
Advisory Opinion 26-16 was requested by a federally qualified health center (FQHC). The FIM intervention involves the provision of weekly produce boxes or produce vouchers to “financially needy” patients with diabetes or hypertension. The purposes of the intervention are to improve patient knowledge and management of diabetes and hypertension, promote healthy eating and sustained lifestyle changes, and reduce the incidence of complications related to chronic health conditions, among other things.
Additional design features of intervention include:
* Participants undergo three health assessments consisting of an initial, midpoint, and final assessment designed to establish baseline health metrics and develop individualized care plans.
* Produce boxes consist of $30 worth of fruits and vegetables and are delivered to the participant’s home.
* Produce vouchers are worth $20 and can be redeemed at local grocery store chains and farmers’ markets.
* Participants must be willing to receive nutrition counseling and behavioral modification counseling.
* While the produce boxes and vouchers are free, certain services included in the intervention, such as counseling, are billed to participants and their insurers as applicable.
* The FQHC wants to grow with the availability of additional funding to include several additional nutrition-sensitive diagnoses: hyperlipidemia, obesity and metabolic syndrome, chronic kidney disease, coronary artery disease, and congestive heart failure.
OIG’s Green Light
Generally, the Anti-Kickback Statute (AKS) and the Civil Monetary Penalties Law (CMPL) Prohibition on Beneficiary Inducements prohibit specific exchanges that induce or reward referrals for items/services payable under a federal health care program or that are likely to influence a federal health care program beneficiary’s selection of a particular provider, practitioner, or supplier.
While stating that free food at issue in the opinion could technically violate anti-kickback and inducements prohibitions, the regulators saw a sufficiently low risk of harm in the arrangement. Accordingly, OIG advised that it would not impose sanctions under the specific facts presented.
The OIG’s reasoning is insightful. Considerations include:
* The program is unlikely to result in overutilization/inappropriate utilization or increased costs to federal health care programs. While certain clinical services included in the intervention are billable services (e.g., health assessments), these services are not inappropriate in the context of the FIM intervention. Instead, these services are part of or otherwise support individualized care plans which could improve patient outcomes and reduce federal health care program costs over time.
* The benefit is limited in duration and value. This reduces concerns about long-term steering of patients to a particular provider.
* Safeguards reduce the risk that food benefits will be used in unintended ways (e.g., ensuring that the vouchers can be used to purchase only healthy food options).
Broader Applications and Implications
FIM programs across the country are likely to see themselves in many of these details. And while an advisory opinion is only applicable to the specific arrangement in question, its implications extend further and can be helpful to others.
First, programs already in place may want to review their operations with this advisory opinion in mind. In addition, for those whose efforts have been stalled by inducements concerns, this opinion opens the door to revisiting the risk assessment. Finally, for advocates seeking clarity in the application of federal fraud and abuse law in these contexts, this opinion is a great starting point to build upon with additional guidance.
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The Center for Health Law and Policy Innovation provides information and technical assistance on issues related to health reform, public health, and food law. It does not provide legal representation or advice. This document should not be considered legal advice. For specific legal questions, consult an attorney.
For more on this topic, additional resources include:
* OIG Issues First Favorable Opinion on “Food-as-Medicine” Program (Adam Falcone, Feldesman LLP, 2026)
* Mitigating Fraud and Abuse Law as a Barrier to Food is Medicine (CHLPI et al., 2025)