Comparison Chart of Anti-Kickback Safe Harbors and Stark Exceptions -- Federally Qualified Health Centers

Federally Qualified Health Centers – Current as of March 2021

Stark [No comparable exception]	Anti-Kickback Safe harbor for payments and other transfers made to a Federally Qualified Health Center
	The transfer is made pursuant to a contract, lease, grant, loan, or other agreement that-- (A) is set out in writing; (B) is signed by the parties; and (C) covers, and specifies the amount of, all goods, items, services, donations, or loans to be provided by the individual or entity to the FQHC.
	The amount of goods, items, services, donations, or loans specified in the agreement may be a fixed sum, fixed percentage, or set forth by a fixed methodology.
	The amount may not be conditioned on the volume or value of federal health care program business generated between the parties.
	The goods, items, services, donations, or loans are medical or clinical in nature or relate directly to services provided by the FQHC as part of the scope of the FQHC section 330 grant (including, by way of example, billing services, administrative support services, technology support, and enabling services, such as case management, transportation, and translation services, that are within the scope of the grant).
	The FQHC reasonably expects the arrangement to contribute meaningfully to the FQHC's ability to maintain or increase the availability, or enhance the quality, of services provided to a medically underserved population served by the FQHC, and the FQHC documents the basis for the reasonable expectation prior to entering the arrangement. The documentation must be made available to the Secretary upon request. At reasonable intervals, but at least annually, the FQHC must re-evaluate the arrangement to ensure that the arrangement is expected to continue to satisfy the standards, and must document the re-evaluation contemporaneously. The documentation must be made available to the Secretary upon request. Arrangements must not be renewed or renegotiated unless the FQHC reasonably expects the standard to be satisfied in the next agreement term. Renewed or renegotiated agreements must comply with the requirements of this paragraph.
	The individual or entity making the payment or transfer does not (i) require the FQHC (or its affiliated health care professionals) to refer patients to a particular individual or entity, or (ii) restrict the FQHC (or its affiliated health care professionals) from referring patients to any individual or entity.
	Individuals and entities that offer to furnish goods, items, or services without charge or at a reduced charge to the FQHC must furnish such goods, items, or services to all patients from the FQHC who clinically qualify for the goods, items, or services, regardless of the patient's payor status or ability to pay. The individual or entity may impose reasonable limits on the aggregate volume or value of the goods, items, or services furnished under the arrangement with the FQHC, provided such limits do not take into account a patient's payor status or ability to pay.
	The agreement must not restrict the FQHC's ability, if it chooses, to enter into agreements with other providers or suppliers of comparable goods, items, or services, or with other lenders or donors. Where a FQHC has multiple individuals or entities willing to offer comparable remuneration, the FQHC must employ a reasonable methodology to determine which individuals or entities to select and must document its determination.
	The FQHC must provide effective notification to patients of their freedom to choose any willing provider or supplier. In addition, the FQHC must disclose the existence and nature of an agreement to any patient who inquires. The FQHC must provide such notification or disclosure in a timely fashion and in a manner reasonably calculated to be effective and understood by the patient.
	The FQHC may, at its option, elect to require that an individual or entity charge a referred FQHC patient the same rate it charges other similarly situated patients not referred by the FQHC or that the individual or entity charge a referred FQHC patient a reduced rate (where the discount applies to the total charge and not just to the cost-sharing portion owed by an insured patient).

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