HHS-OIG Updates Fraud and Abuse FAQs: Stark Law Compliance and Fair Market Value Do Not Insulate Against Anti-Kickback Statute Liability

By Claudia E. Stedman, Paul J. Giancola, Scott S. Driggs, and EJ Odigwe

On April 23, 2026, the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) updated its FAQs on General Questions Regarding Certain Fraud and Abuse Authorities with two notable additions: a revised FAQ No. 4 addressing the interplay between the physician self-referral law (Stark Law) and the federal Anti-Kickback Statute (AKS), and a new FAQ No. 17 clarifying the role of fair market value (FMV) in AKS compliance. Together, these updates target two persistent misconceptions in the healthcare industry: (1) that satisfying a Stark Law exception eliminates AKS risk; and (2) that FMV remuneration is the gold standard to avoid kickback liability.

Updated FAQ No. 4: Stark Law Compliance Does Not Equal AKS Compliance

A common misunderstanding in the healthcare industry is that because many Stark exceptions and AKS safe harbors share similar — and sometimes identical — elements, satisfying a Stark exception automatically renders an arrangement safe and compliant under the AKS. HHS-OIG’s revised FAQ No. 4 directly addresses this misconception, now explicitly stating that a financial arrangement that satisfies the requirements of a Stark Law exception can still violate the AKS.

HHS-OIG emphasizes several foundational distinctions between the two statutes. First, the Stark Law is a civil, strict liability statute, which means that intent is irrelevant. The AKS, by contrast, is an intent-based statute — knowing and willful intent to induce or reward referrals is the core inquiry. Compliance with a Stark Law exception therefore does not by itself demonstrate that the parties lack the requisite intent under the AKS.

To illustrate this point, HHS-OIG offers a practical example: Hospitals, laboratories, or other healthcare providers may offer sporting event tickets or entertainment to referring physicians. Such arrangements may, depending on the facts, satisfy Stark’s non-monetary compensation exception under 42 C.F.R. § 411.357(k), which protects non-cash items of value up to an annual per-physician cap (currently $535.00 for calendar year 2026). However, the AKS has no equivalent safe harbor for such remuneration. Accordingly, HHS-OIG warns that providing such items of value with the requisite intent could violate the AKS, even if the arrangement satisfies Stark. However, the arrangement may nevertheless be deemed to not implicate the AKS under a totality of the circumstances analysis, including review of the parties’ intent.

Updated FAQ No. 17: Fair Market Value Alone Is Not a Defense to AKS Liability

New FAQ No. 17 asks whether arrangements involving FMV remuneration can violate the AKS. HHS-OIG’s answer unequivocally states that while ensuring that remuneration is consistent with FMV is a best practice and is often one required element of an AKS safe harbor, FMV alone is not a defense to AKS liability.

HHS-OIG also notes that the text of the AKS prohibition does not even use the term “fair market value,” and no safe harbor protects remuneration solely because it is FMV. Protection under an AKS safe harbor requires each stream of remuneration to satisfy each condition of the applicable safe harbor — FMV is just one of several conditions that many of the AKS’ safe harbors require. Parties that focus exclusively on FMV risk but overlook other safe harbor requirements, including commercial reasonableness (i.e., that the arrangement is for a legitimate business purpose) requirements.

HHS-OIG characterizes its position on this issue as “consistent and unwavering,” pointing to its compliance program guidance, a 2014 Special Fraud Alert, and recent advisory opinions.

Practical Implications

Although neither FAQ announces new standards or law, the simultaneous release of these two updates is significant. HHS-OIG appears focused on dispelling two closely related myths that continue to surface in enforcement matters: (1) that Stark Law compliance eliminates AKS risk; and (2) that compensation or remuneration paid at FMV insulates an arrangement from AKS liability.

These updates are part of HHS-OIG’s ongoing use of FAQs as a compliance resource, a channel it opened in 2023 to answer general industry questions about the AKS, the Beneficiary Inducements civil monetary penalty, and related enforcement topics. While the FAQs offer useful guidance for day-to-day compliance decisions, they are not binding and do not protect any specific arrangement from enforcement.

Healthcare organizations should take note of the following considerations in light of these FAQs:

FMV documentation alone is insufficient. The better practice is to pair FMV with documentation of a legitimate business purpose that would withstand scrutiny absent any referrals. Each stream of remuneration must be evaluated against the full set of conditions of an applicable safe harbor. Nonmonetary benefits — such as entertainment, gifts, and other noncash items of value — warrant particular care under the AKS even when a Stark exception applies. For novel or close-to-the-line arrangements, the OIG Advisory Opinion process remains available for binding, arrangement-specific analysis.