DOJ OIG: Stark Law, FMV Compliance Not Enough to Dodge Anti-Kickback Risk
The HHS OIG clarified that Stark Law and fair market value compliance do not guarantee Anti-Kickback Statute protection.
Why it matters: Health law professionals and corporate counsel face increased scrutiny, as arrangements previously considered compliant may still trigger liability. Clear separation of compliance strategies is now essential to mitigate risk.
- On April 23, 2026, HHS OIG added two FAQs on Stark Law and Anti-Kickback overlap.
- FAQ #4 affirms that Stark Law compliance does not equate to AKS compliance.
- FAQ #17 clarifies that fair market value alone can't shield from AKS violations if intent to induce referrals exists.
- OIG emphasizes the distinct purposes and requirements of Stark and AKS.
The U.S. Department of Health and Human Services Office of Inspector General (OIG) released new FAQs on April 23, 2026, warning that compliance with the physician self-referral law (Stark Law) and fair market value (FMV) standards is not sufficient to avoid Anti-Kickback Statute (AKS) risk.
- FAQ #4, as outlined by the OIG, states, “Compliance with a Stark exception is not evidence that the parties lack AKS intent.” Ensuring an arrangement fits a Stark Law exception does not prove it was free from kickback intent under AKS review.
- FAQ #17 reiterates that “fair market value is just one element and that compliance with a safe harbor requires meeting each element.” The OIG rejects the notion that FMV alone neutralizes allegations of unlawful remuneration under the AKS, dissociating this stance from statutory language and longstanding guidance.
The distinction is crucial: The Stark Law is a strict liability statute, with intent irrelevant, while the AKS requires knowing and willful conduct to induce referrals. The OIG offered an example in its guidance, explaining that hospital gifts, such as sporting event tickets to referring physicians, could meet a Stark exception yet still violate the AKS.
This position underscores the need for healthcare entities to design financial relationships that withstand scrutiny under both statutes—not just one—and signals the OIG’s focus on aggressive AKS enforcement. For legal and compliance professionals, this means adopting a multi-pronged approach when assessing risk.
See full industry analysis at the National Law Review.
By the numbers:
- April 23, 2026 — Date of new OIG FAQs on Stark Law and AKS.
- FAQ #4, FAQ #17 — Key clarifications on compliance limits.