HHS-OIG Issues Favorable Opinion on Food-as-Medicine Program Offered by Federally Qualified Health Center

HHS-OIG recently issued Advisory Opinion No. 26-16, a favorable opinion addressing an FQHC “food-as-medicine” program under the AKS and the Beneficiary Inducements CMP. “Food-as-medicine” generally refers to the concept of integrating nutrition support services such as produce prescriptions, medically tailored meals, or healthy grocery programs into traditional healthcare to prevent, manage, and treat diet-related chronic illnesses, such as diabetes and heart disease. Although HHS-OIG found that the arrangement potentially implicates both statutes and is not protected by any safe harbor or exception, the agency declined to pursue sanctions given the program’s built-in safeguards. The opinion offers a useful roadmap for FQHCs and other providers designing social determinants of health programs that pair free items with billable clinical services.

Background: HHS-OIG’s Food-as-Medicine Program for FQHC Patients

The requestor is an FQHC authorized by the Health Resources and Services Administration (HRSA) to provide a “food-as-medicine” program. Requestor proposed a six-month program for up to 50 financially needy patients with diabetes or hypertension. Over a six-month period, participants receive weekly produce boxes worth approximately $30 or vouchers worth approximately $20 at no charge, plus three health assessments (to include dietitian or physician visits, lab testing, and behavioral counseling) that the requestor bills participants and insurers. A third-party voucher company monitors voucher redemption through data tracking, receipt checks, site visits, and retailer memoranda of understanding (MOUs) to ensure that vouchers are only used to purchase healthy food options. The program is funded in part by grants, and the requestor intends to expand it to additional chronic-condition diagnoses if funding allows.

Why HHS-OIG Found the FQHC Food-as-Medicine Program Low-Risk Under the AKS and Beneficiary Inducements CMP

HHS-OIG observed that the free produce could induce participants to obtain billable health assessment services, implicating the AKS, and could influence their choice of provider for reimbursable services, implicating the Beneficiary Inducements CMP. No AKS safe harbor applies, and the CMP’s Financial Need-Based Exception does not apply because the free items are tied to other reimbursable services.

However, the agency found the combined risk of fraud and abuse low because:

• The benefit is in-kind, narrowly tailored to disease management, and consistent with the requestor’s FQHC mission and HRSA-approved scope of services.
• The program is limited in value and duration — one item per week for six months — and participants retain cost-sharing obligations for the billable assessment services.
• The health assessments are designed to produce individualized care plans that could improve outcomes and reduce long-term federal healthcare program costs, rather than drive unnecessary utilization.
• Independent, third-party oversight of the voucher component — including data tracking, receipt checks, site visits, cashier training, and retailer MOUs — limits the risk that benefits are diverted from their intended purpose.
• Recipients are required to demonstrate financial need to receive the produce boxes or vouchers.

HHS-OIG ultimately declined to impose sanctions under either authority based on the totality of these safeguards.

Key Takeaways for FQHCs and Other Providers Designing Food-as-Medicine Programs

This advisory opinion signals that HHS-OIG will tolerate remuneration flowing from food-as-medicine and similar social determinants of health programs when providers build in sufficient safeguards, even without an applicable safe harbor or exception. FQHCs are especially well-positioned to rely on this reasoning because their HRSA-approved scope of services already anticipates nutrition-related offerings. But the same design principles are instructive for hospitals, health systems, and other providers exploring comparable programs.

Providers designing similar programs should: 

1. Keep free benefits in-kind, narrowly tailored to a clinical purpose, and limited in value and duration,
2. Preserve patient cost-sharing obligations on any billable services layered into the program,
3. Engage an independent third party to monitor redemption and prevent diversion, supported by contractual MOUs with participating retailers, and
4. Document how the program design connects to measurable clinical outcomes, rather than referral generation.

Because this opinion is binding only on the requestor with respect to the certified facts presented, it cannot be relied on by other entities, does not address other laws such as the physician self-referral (Stark) law or the False Claims Act, and does not extend to expanded patient populations or program modifications. Providers should not assume comparable protection for scaled or materially different programs and should seek their own advisory opinion or individualized counsel before implementation.