Table 2.

Safe Harbors and Exceptions Applicable to Furnishing Food-Related Supports

Scope of immunity	Permissible goals	Permissible form(s) of support		Eligible patients	Monetary limits
Patient Engagement and Support Safe Harbor (42 C.F.R. § 1001.952(hh))
Anti-Kickback Statute (AKS) and beneficiary inducements prohibition of the Civil Monetary Penalties Law (CMPL)	Includes prevention or management of a condition as recommended by patient’s health care provider	- In-kind items, goods, or services (e.g., on-site food pantries, food vouchers) are permissible - Cash or cash equivalents (e.g., general purpose gift cards) are impermissible - Health care providers are permitted to contract with CBOs to furnish supports to patients		Patients in a “target population” (e.g., patients with chronic diabetes or another specific illness)	Aggregate retail value of tools and supports provided to a patient cannot exceed $570 in 2023 (cap is adjusted annually for inflation)
Safe Harbor for Centers for Medicare and Medicaid Services (CMS) Model Arrangements (42 C.F.R. § 1001.952(ii))
AKS and CMPL	Allows health care organizations participating in a model tested by the CMS Innovation Center (CMS-sponsored model) to provide free or discounted items to patients to advance a goal of the CMS-sponsored model	Depends on the CMS-sponsored model Notes: • Meal program vouchers to address malnutrition is an allowable incentive by Medicare Shared Savings Program Accountable Care Organizationsa • Per guidance, the provision of food vouchers to a Medicare Diabetes Prevention Program participant living in a “food desert” is an allowable — and often effective — tool because it supports Type 2 diabetes risk reductionb • Per guidance, giving “multiple free meals or meal replacement services … over a substantial portion” of a person’s participation in the Medicare Diabetes Prevention Program is not permittedc		Depends on the CMS-sponsored model	Depends on the CMS-sponsored model
Financial Need-Based Exception (42 C.F.R. § 1003.110(8))
CMPL	Improving access to supports that have a reasonable connection to a patient’s medical care	- Items, goods, and services - Cash or cash equivalents are impermissible		- Patients with “financial need” as determined through a good faith and individualized assessment - Providers are not required to use any specific basis for determining need but a uniformly applied policy is requiredd - Enrollment in Medicaid may be used for the assessmentd - A food insecurity screening tool (e.g., Hunger Vital SignTM) may be permissible for determining need where the provider can be reasonably comfortable accepting only a patient’s statement of need (e.g., the provider is located in a low-income area and generally serves low-income patients)d	The cost of the intervention cannot be “too large” compared to value of the serviced Note: Guidance states that providing meal deliveries for a “limited period of time” after a patient is discharged following a debilitating procedure may be reasonable but that paying for a subscription to a “long-term” meal delivery service for a patient with diabetes is not reasonabled
Preventive Care Exception (42 C.F.R. § 1003.110(4))
CMPL	Incentivizing a patient to access an eligible service	Incentives do not need to be related to care		Patients in need of certain clinical preventive services including prenatal services, well-baby visits	The cost of the incentive cannot be “too large” compared to the value of the service
Promotes Access to Care Exception (42 C.F.R. § 1003.110)
CMPL	Supporting a patient’s ability to obtain medically necessary care	- Items/services that improve access to care while posing a low risk of harm to patients and health care programs - Cash or cash equivalents are impermissible Notes: • In one advisory opinion, regulators approved an arrangement to provide lodging and free meals to low-income patients from rural and/or medically underserved areas who have an early morning appointment or need follow-up caree • Per guidance, food vouchers/meal services to “promote access to healthy living” do not meet the requirements of this exception and are thus not protected under the exceptiond		Patients who face socioeconomic, geographic, or other barriers to accessing care	No specific limit imposed

^aMedicare Program; Medicare Shared Savings Program; Accountable Care Organizations-Pathways to Success and Extreme and Uncontrollable Circumstances Policies for Performance Year 2017, 83 Fed. Reg. 67816 (Dec. 31, 2018); 42 C.F.R. § 425.304.

^bMedicare Learning Network, Transcript, Medicare Diabetes Prevention Program: Supplier Enrollment Call (2018), available at https://www.cms.gov/Outreach-and-Education/Outreach/NPC/Downloads/2018-06- 20-MDPP-Transcript.pdf.

^cMedicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program, 82 Fed. Reg. 53331 (Nov. 15, 2017).

^dMedicare and State Health Care Programs: Fraud and Abuse; Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements, 81 Fed. Reg. 88368 (Dec. 7, 2016).

^eHHS OIG Advisory Opinion No. 17-01 (2017), at https://www.oig.hhs.gov/fraud/docs/advisoryopinions/2017/AdvOpn17-01.pdf.