New OIG FAQs Clarify 2 Common Federal Anti-Kickback Statute Misconceptions

Neither Stark Law compliance nor "Fair Market Value" (FMV) compensation shields arrangements from the federal Anti-Kickback Statute (AKS), the U.S. Department of Health and Human Services Office of Inspector General (OIG) reminds the healthcare industry.

On April 23, 2026, the OIG updated its General Questions Regarding Certain Fraud and Abuse Authorities FAQ page with two significant additions: 1) a revised FAQ No. 4 addressing the interplay between the physician self-referral law (commonly known as the Stark Law) and the AKS, and 2) a new FAQ No. 17 clarifying the role of FMV in AKS compliance. Together, these updates dispel two commonly held misconceptions about AKS risk management, reminding the industry that AKS analyses are truly facts-and-circumstances-specific evaluations unique to each arrangement.

FAQ No. 4: Stark Compliance Is Not AKS Compliance

A common misunderstanding in the healthcare industry is that because Stark Law exceptions and AKS safe harbors often share similar (and sometimes identical) elements, particularly for compensation arrangements, satisfying a Stark Law exception automatically renders an arrangement safe (or at least low-risk) under the AKS. That assumption is reinforced by the fact that the AKS safe harbors and Stark Law exceptions often cross-reference each other. For example, certain AKS safe harbors rely on the Stark Law "group practice" definition, and certain Stark Law exceptions are conditioned on compliance with AKS. This misconception is often further perpetuated by the fact that some Stark Law exceptions are more technical than their AKS counterparts, leading to the mistaken inference that Stark Law compliance equates to AKS compliance.

The OIG, however, reminds us that this is an apples-to-oranges comparison. Highlighting the fact that the goals, intent requirements and regulatory framework of the AKS are separate and apart from the Stark Law, the OIG explains that "a party that knowingly and willfully offers and pays any remuneration to induce, or solicits or receives any remuneration in return for, Federal health care program referrals could be liable under the [AKS] even if the financial arrangement at issue satisfies the requirements of an exception to the [Stark Law]."

The OIG helpfully provides an example: Under the Stark Law's Nonmonetary Compensation exception, noncash items or services of value such as tickets to sporting events and other entertainment to physicians are protected under the Stark Law as long as they fall under the annual cap on a per-physician basis.¹ However, the AKS has no equivalent safe harbor. Accordingly, the OIG warns that providing such items of value with the requisite intent present could violate the AKS, even if the arrangement satisfies the Stark Law exception.

FAQ No. 17: FMV Is Only One Aspect of AKS Evaluations

In a new FAQ No. 17, the OIG highlighted a common myth: "… [S]ome health care industry stakeholders have taken the position that, so long as the remuneration offered, paid, solicited, or received in an arrangement is consistent with fair market value … there can be no liability under the Federal anti-kickback statute."

It is true that in compensation arrangements, one of the core tenants of evaluating AKS risks asks whether the compensation exchanged reflects FMV for the services provided. Indeed, FMV compensation is one of the required elements in many AKS safe harbors, including for Personal Services, Equipment Rental and Space Rental.

The OIG's new FAQ reminds stakeholders that the analysis does not end there: An arrangement can still violate the AKS even if the remuneration is FMV. As the OIG notes, the term "fair market value" does not even appear in the AKS; it appears in only certain regulatory safe harbors as one of many elements required to be afforded protection. In other words, FMV may be a necessary condition to meet a safe harbor, but it is not sufficient on its own.

Of course, it remains best practice to ensure that all payments that implicate the AKS fall within FMV range. However, the OIG's new guidance, though not based on any new principles, serves as a clear reminder that FMV is only a piece of a broader facts and circumstances analysis and FMV pricing alone will not shield an arrangement from scrutiny.

Concluding Thoughts

It is easy in the healthcare industry to fall victim to misunderstandings and misconceptions about key fraud and abuse laws, including in-house and outside counsel. FAQs nos. 4 and 17 appear to be the OIG's reminder that a black-and-white approach to AKS compliance could result in a miscalculation of regulatory risks. Each arrangement must be evaluated on a case-by-case basis, with attention paid to the letter, spirit, and purpose of the AKS and its regulations rather than by assumptions drawn from or analogies to similar laws.

Notes

¹ 42 CFR § 411.357(k). For calendar year 2026, the Nonmonetary Compensation limit is $535 per physician per year. Centers for Medicare & Medicaid Services, CPI-U Updates Nonmonetary Compensation, Medical Staff Incidental Benefits, and Limited Remuneration to a Physician Exceptions.