Health Law Daily Wrap Up, ANTI-KICKBACK PROHIBITION—OIG ADVISORY OPINIONS: ‘Additional services’ provider can refer own primary care service per HHS advisory opinion, (Apr 14, 2025)

By Leah S. Poniatowski, J.D.

Federal laws preventing remuneration under the proposed physician referral service, including the anti-kickback statute, would not be imposed by HHS provided method of referral conforms to terms of proposed arrangement.

A provider of “additional services” serving a low-income community requested an advisory opinion from the Office of Inspector General (OIG) of HHS as to whether it could also refer its own physicians to community members who are not in the regular care of a primary care doctor without running afoul of the federal laws prohibiting providers from benefiting themselves through self-referrals. Because the provider included safeguards vis-a-vis the referrals, the OIG was satisfied that the arrangement could be implemented without triggering federal law, on condition that the strict terms be followed (OIG Advisory Opinion, No. 25-02, Apr. 9, 2025).

Background. A community health center under Section 330 of the Public Health Service Act (42 U.S.C. § 254b), provides both medical and non-medical services to individuals regardless of their ability to pay for the services. Examples of “additional services” it provides are lock changes for crime victims, and supplies for babies and young children. The center observed that individuals who received additional services were not accessing the center for health care services, largely believed to be because the individuals did not have either the financial resources for care or did not understand how to access care.

The center proposed asking those individuals when they access the additional services if they have seen a primary care physician within the last year and if they had not, the center would provide a list of providers that included its own physicians. The list would organize the doctors alphabetically and not emphasize which ones were affiliated with the center. Additionally, access to the additional services would not be impacted on the choice the individual made. According to the center, it would schedule an appointment if an individual chose one of their physicians and would provide an electronic referral to the other physicians on the list.

Federal law. However, under the federal anti-kickback law (§§ 1128A(a)(7) and 1128B(b) of the Social Security Act), it is a crime to arrange or recommend services to another that are reimbursable under a federal health care program. Similarly, civil monetary penalties can be imposed for the same acts.

Proposed arrangement. The OIG acknowledged that the proposed arrangement does implicate the anti-kickback statute, but the safeguards included in the arrangement are sufficient to significantly reduce the risk of fraud and abuse. Specifically, the arrangement: (1) uses the objective criteria of whether a community member has seen a primary care doctor within the last year or not, which does not promote the center; (2) the list provided to community members as indicated would not promote the center; (3) the use of the “any willing provider” standard and ensuring the list included several other physician options; (4) the assurance that the community members would continue to receive the additional services regardless of the their choice to access health care services; and (5) the center would assist the individual in contacting the other physicians.

OIG determination. The OIG explained that without the safeguards, such an arrangement would likely be in violation of federal law, but without the requisite self-dealing intent, can help the center fulfill its legal obligation to provide care for the community members. The OIG added that the advisory opinion was limited with respect to: the scope of the proposed arrangement, to the center, the statutory provisions identified in the opinion, to HHS, among others. The OIG agreed not to proceed against the center on condition the center has acted and will continue to act in good faith reliance upon the advisory opinion.

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