On April 23, 2026, the U.S. Department of Health and Human Services Office of Inspector General (OIG) updated its General Questions Regarding Certain Fraud and Abuse Authorities FAQs with two important clarifications under the federal Anti-Kickback Statute (AKS). OIG revised FAQ No. 4 to address whether compliance with the physician self-referral law (Stark Law) protects arrangements under the AKS and added new FAQ No. 17 addressing the role of fair market value (FMV) in AKS compliance.
Although the positions articulated by OIG are not new, the updates are notable for their rigid pronouncements. They reinforce a core enforcement principle for health care providers, management companies, investors, and others structuring financial relationships in the health care industry: compliance with Stark Law exceptions or reliance on FMV compensation does not, standing alone, insulate an arrangement from AKS scrutiny.
Revised FAQ No. 4: Stark Law Compliance Does Not Equal AKS Compliance
In revised FAQ No. 4, OIG addresses the notion that satisfying a Stark Law exception materially reduces AKS risk. OIG confirms that a financial arrangement may fully comply with a Stark Law exception yet still violate the AKS, depending on the facts and circumstances.
OIG explains that the Stark Law and the AKS serve different purposes, prohibit different conduct, and impose distinct consequences. The Stark Law is a strict liability statute focused on prohibiting certain financial relationships regardless of intent, while the AKS is an intent-based statute prohibiting the knowing and willful exchange of remuneration to induce or reward referrals of items or services reimbursable by a federal health care program.
Critically, OIG emphasizes that compliance with a Stark Law exception does not rebut or negate improper intent under the AKS. A party may satisfy every technical element of a Stark Law exception and still possess the intent required to violate the AKS. OIG also cautions that Stark Law exceptions and AKS safe harbors, even where similarly titled or structured, are distinct and must be analyzed independently.
To illustrate this distinction, OIG highlights the example of providing tickets to sporting events or other entertainment to physician referral sources. This type of remuneration may, depending on the facts and circumstances, satisfy the Stark Law exception for nonmonetary compensation. However, OIG stated that it is unlikely to receive protection under an AKS safe harbor and remains subject to a totality-of-the-circumstances analysis, including scrutiny of the parties’ intent.
The OIG’s example is a curious choice. Under the Stark Law exception for nonmonetary compensation, physicians, their practices, and their employees cannot solicit the compensation, and the compensation cannot be determined in a manner that takes into account the volume or value of referrals or other business generated by the referring physician. When combined with the relatively modest annual cap on nonmonetary compensation ($535) these guardrails make a compelling case that remuneration which falls within the exception was not intended to induce referrals.
Added FAQ No. 17: Fair Market Value Is Not a Safe Harbor
New FAQ No. 17 addresses whether arrangements involving compensation consistent with FMV violates the AKS. OIG affirmed that an arrangement may violate the AKS even where remuneration is consistent with FMV.
While ensuring compensation is consistent with FMV is a best practice and may reduce risk, OIG emphasizes that FMV is not referenced in the AKS and is not a dispositive defense. Although some AKS safe harbors incorporate FMV requirements, it is only one of several required elements.
OIG further cautions against the position that FMV compensation eliminates the existence of unlawful remuneration. According to OIG, this interpretation is inconsistent with statutory text, applicable regulations, and long-standing agency guidance. Instead, AKS liability turns on the facts and circumstances surrounding the arrangement, including whether remuneration is intended to induce or reward referrals.
Practical Implications
Taken together, these FAQs reinforce several important compliance considerations.
First, providers and other industry participants should exercise caution when treating Stark Law compliance as a proxy for AKS compliance. Separate, intent-focused AKS analyses remain essential, particularly given AKS case law holding that if even one purpose of providing remuneration is to induce or reward referrals, the arrangement may violate the AKS.
Despite the OIG’s rigid view, an individual’s or entity’s good-faith efforts to comply with a Stark Law exception are more than minor indicia of lawful intent and should be considered when evaluating an arrangement’s propriety. Because many Stark Law exceptions require that an arrangement be commercially reasonable and not take into account the volume or value of referrals or business generated by the referring physician (factors OIG examines during a “facts-and-circumstances” analysis), compliance with the Stark Law does, in fact, correlate with an arrangement representing low risk under the AKS. While it is possible for an arrangement to meet a Stark Law exception but still present risk under the AKS, this outcome is unlikely to occur in practice.
Second, valuation opinions and FMV analyses, while important, should be viewed as necessary but not sufficient compliance tools. They should be combined with documentation of legitimate business purpose, commercial reasonableness, and operational need, independent of referrals.
Those elements—FMV and commercial reasonableness in the absence of referrals—comprise the core of several OIG safe harbors, including for personal services and management contracts, and offer a powerful rebuttal that an individual or entity possessed an improper intent when paying remuneration. Moreover, while the OIG’s position on FMV in isolation is correct, the likelihood that a party would gain comfort with an arrangement that involves FMV compensation but clearly lacks commercial reasonableness is low.
Third, the principles highlighted by OIG are particularly relevant in transactional settings, where diligence often focuses on Stark technical compliance and FMV support. OIG’s guidance underscores the need for buyers and investors to evaluate referral dynamics, compensation structure, and surrounding facts to assess residual AKS exposure that may persist notwithstanding Stark compliance or FMV support and broader compliance considerations, rather than relying solely on valuation analyses.
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