Anti-Kickback Safe Harbor
Statutory exception for any remuneration between a federally qualified health center and any individual or entity providing goods, items, services, donations, loans, or a combination thereof, to such federally qualified health center pursuant to a contract, lease, grant, loan, or other agreement, if such agreement contributes to the ability of the federally qualified health center to maintain or increase the availability, or enhance the quality, of services provided to a medically underserved population served by the federally qualified health center, plus a regulatory safe harbor if the following nine standards are met:
1. (i) 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 health center.
(ii) 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.
2. The goods, items, services, donations, or loans are medical or clinical in nature or relate directly to services provided by the health center as part of the scope of the health center's 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).
3. The health center reasonably expects the arrangement to contribute meaningfully to the health center's ability to maintain or increase the availability, or enhance the quality, of services provided to a medically underserved population served by the health center, and the health center documents the basis for the reasonable expectation prior to entering the arrangement. The documentation must be made available to the Secretary upon request.
4. At reasonable intervals, but at least annually, the health center must re-evaluate the arrangement to ensure that the arrangement is expected to continue to satisfy the standard of this safe harbor, and must document the re-evaluation contemporaneously. The documentation must be made available to the Secretary upon request.
5. The individual or entity does not:
(i) Require the health center (or its affiliated health care professionals) to refer patients to a particular individual or entity, or
(ii) restrict the health center (or its affiliated health care professionals) from referring patients to any individual or entity.
6. Individuals and entities that offer to furnish goods, items, or services without charge or at a reduced charge to the health center must furnish such goods, items, or services to all patients from the health center 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 health center, provided such limits do not take into account a patient's payor status or ability to pay.
7. The agreement must not restrict the health center'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 health center has multiple individuals or entities willing to offer comparable remuneration, the health center must employ a reasonable methodology to determine which individuals or entities to select and must document its determination.
8. The health center must provide effective notification to patients of their freedom to choose any willing provider or supplier. In addition, the health center must disclose the existence and nature of an agreement under paragraph (w)(1) of this section to any patient who inquires. The health center must provide such notification or disclosure in a timely fashion and in a manner reasonably calculated to be effective and understood by the patient.
(9) The health center may, at its option, elect to require that an individual or entity charge a referred health center patient the same rate it charges other similarly situated patients not referred by the health center or that the individual or entity charge a referred health center 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).
The term “health center” means a Federally Qualified Health Center under section 1905(l)(2)(B)(i) or 1905(l)(2)(B)(ii) of the Act, and “medically underserved population” means a medically underserved population as defined in regulations at 42 CFR 51c.102(e).
10. Federally Qualified Health Centers
Sources: 42 U.S.C. § 1320a-b(b)(3)(I) and 42 C.F.R. § 1001.952(w)