On April 23, 2026, the HHS Office of Inspector General (OIG) quietly—but pointedly—added two new FAQs to its “General Questions Regarding Certain Fraud and Abuse Authorities.” Although the principles articulated are not new, the timing and clarity of these FAQs reflect OIG’s continued effort to correct common—and risky—misunderstandings in the health care industry regarding the federal Anti‑Kickback Statute (AKS), the physician self‑referral law (“Stark”), and the role of fair market value (FMV) analyses. Together, these FAQs serve as a reminder that technical compliance with Stark or reliance on a fair market benchmark do not, standing alone, insulate an arrangement from AKS scrutiny.
The first new FAQ is FAQ #4: “Could a financial arrangement that satisfies an exception to the physician self-referral law (42 U.S.C. § 1395nn) violate the federal anti-kickback statute?” In its answer, OIG squarely addresses a persistent misconception that satisfying a Stark exception somehow rebuts AKS risk. OIG emphasizes several foundational points:
- Stark and AKS serve different purposes, prohibit different conduct, and impose different consequences;
- Stark is a strict liability statute; intent is irrelevant;
- AKS is an intent‑based statute; knowing and willful intent to induce referrals is the core inquiry; and
- Compliance with a Stark exception is not evidence that the parties lack AKS intent.
Even where a financial arrangement “fits” squarely within a Stark exception, the arrangement may still violate AKS if one purpose of the remuneration is to induce or reward referrals. To illustrate this point, the OIG provides the “sporting event” example. It pointed out that hospitals, laboratories, or other providers may offer sporting event tickets or entertainment to referring physicians. OIG acknowledges that such arrangements might, depending on facts, technically satisfy the Stark exception for nonmonetary compensation under 42 C.F.R. § 411.357(k). However, OIG warns that these forms of remuneration are “unlikely to receive protection under any safe harbor to the federal anti-kickback statute” and therefore remain subject to totality‑of‑the‑circumstances review, including intent. Importantly, OIG reiterates its long‑standing position that providing remuneration to referral sources can violate AKS regardless of Stark compliance, a theme echoed in enforcement actions and advisory opinions over many years.
The second new FAQ is FAQ #17: “Can fair market value arrangements violate the federal anti-kickback statute?”This FAQ tackles another common compliance belief that fair market value may be the sole compliance cornerstone for AKS purposes. OIG again says no. While confirming that fair market value analyses are important and often one of the elements of a safe harbor, OIG stresses that fair market value is just one element and that compliance with a safe harbor requires meeting each element. As discussed in a prior podcast with the American Health Law Association, there are other factors that are important including commercial reasonableness.
OIG expressly rejects the industry argument that FMV eliminates unlawful remuneration, calling that position inconsistent with (i) the statutory text, (ii) the regulatory safe harbors, and (iii) decades of OIG guidance that OIG characterizes as “consistent and unwavering.”
Why These FAQs Matter Now
Although neither FAQ announces new law, their explicit pairing and contemporaneous release is notable. OIG appears focused on dispelling two closely related myths that continue to surface in enforcement matters:
- “We meet Stark, so AKS isn’t a problem.”
- “We paid fair market value, so there’s no kickback.”
For entities in the healthcare space, these FAQs signal that you must look at the totality of the arrangement and ask the hard questions surrounding the relationship.
