The U.S. Department of Health and Human Services Office of Inspector General (OIG) updated its FAQs on Fraud and Abuse Authorities to add a new answer on fair market value (FMV) in FAQ 17 and revise the answer on how the physician self-referral law (Stark Law) overlaps with the federal Anti-Kickback Statute (AKS) in FAQ 4. The takeaway from FAQ 4 and FAQ 17 is clear: An arrangement can violate the AKS even if the compensation is FMV or the arrangement fits within a Stark Law exception.
This update is not new law, but it is a strong reminder that AKS liability turns on intent, not on FMV or Stark Law compliance alone.
What the New FAQs Say, At a Glance
FAQ 17 is new. It asks whether arrangements with FMV remuneration can violate the AKS. OIG’s answer is that FMV is good practice (and often a required element of a safe harbor), but FMV alone is not a defense. AKS liability depends on the facts of the arrangement and the parties’ intent. The text of the AKS prohibition does not even use the term “fair market value,” and no safe harbor protects remuneration just because it is at FMV. Some safe harbors include FMV as one condition among several, but parties that focus only on FMV miss the other safe harbor conditions. OIG calls its position here “unwavering,” pointing to its compliance program guidance, a 2014 Special Fraud Alert (see page 4), and recent advisory opinions.
Revised FAQ 4 (see our generated comparison redline) now begins with an explicit “Yes”: A financial arrangement that satisfies a Stark Law exception can still violate the AKS. OIG explains that the Stark Law and AKS are separate statutes; the Stark Law is a civil strict liability statute, while intent is a critical element of the criminal AKS. Compliance with a Stark Law exception therefore does not by itself show the party lacks the intent that violates the AKS. Consider OIG’s example. Giving sporting event tickets to a physician who refers patients may fit the Stark Law’s nonmonetary compensation exception (42 C.F.R. § 411.357(k)), but it is unlikely to fit any AKS safe harbor, and the government would look at the full picture, including what the parties intended. Giving anything of value to induce or reward referrals may violate the AKS if the requisite intent is there, regardless of whether a Stark Law exception is also satisfied.
Practically, Why FMV and Stark Law Compliance Do Not Solve AKS Risk
The way AKS safe harbors work helps explain why FMV and Stark Law compliance matter but do not end the analysis. A safe harbor protects an arrangement from being treated as an AKS offense only when every element of that safe harbor is met in full. The space rental, equipment rental, and personal services and management contracts safe harbors are good examples. Each requires that compensation be consistent with FMV and not be set in a way that takes into account the volume or value of referrals or other business between the parties. Each also imposes a commercial reasonableness condition (i.e., the deal must make business sense): The space, equipment, or services may not exceed what is reasonably necessary for the commercially reasonable business purpose of the arrangement. That commercial reasonableness piece ties these safe harbors back to OIG’s prior guidance, including the sources cited in FAQ 17, which has long cautioned that even where contracts look fine on paper, sham arrangements will not be protected. Practically, the government will look behind the agreement to see whether payments are really tied to referrals.
There is no “FMV‑alone” safe harbor under the AKS. FAQ 17 reinforces that each stream of remuneration must squarely satisfy each condition of an applicable safe harbor to receive protection. When an arrangement does not fit a safe harbor, AKS exposure depends on the facts and circumstances, including the parties’ intent and whether the arrangement would make business sense even without the referrals. As OIG puts it, “while adhering to the practice of ensuring the fair market value of remuneration is a highly useful general practice, it is not a guarantee of legality.” The same is true for Stark Law exceptions: meeting one is required for Stark Law compliance, but it does not, on its own, shield the arrangement from AKS scrutiny.
The practical takeaway is to treat FMV and Stark Law exceptions as an initial foundation, not a cure for AKS risk. Either meet every element of an applicable AKS safe harbor or be ready to show, with contemporaneous documentation, that there was no knowing and willful inducement or reward for referrals (in plain terms, that the arrangement was not set up to encourage referrals). That documentation should include the legitimate business need for the arrangement and the deliverables that hold up regardless of any referrals. As the entertainment example above illustrates, nonmonetary benefits still warrant particular care under the AKS even when a Stark Law exception applies. For novel or close-to-the-line arrangements, the OIG Advisory Opinion process remains available for binding, arrangement‑specific analysis. The FAQs are a different tool, offering useful informal feedback for day‑to‑day compliance choices, but they are not binding and do not protect any specific arrangement from enforcement.
Where This Fits in OIG’s Informal Guidance Effort Since 2023
The April 23, 2026, updates are part of OIG’s ongoing use of informal FAQs as a compliance resource. OIG opened this channel in 2023 to take general questions about the AKS, the Beneficiary Inducements civil monetary penalty (CMP) and related enforcement topics, while keeping the formal Advisory Opinion process for binding, fact‑specific determinations. As we discussed in our April 2023 overview, OIG launched the FAQs to answer general industry questions faster and more efficiently. Recently, OIG also added an Advisory Opinion FAQ addressing what happens if the facts or law change after issuance of a favorable opinion. The April 2026 updates show that OIG is in fact maintaining and refreshing the FAQs over time.
Conclusion
The underlying law has not changed with these FAQs, but OIG’s message is worth hearing again: Documenting FMV or fitting within a Stark Law exception does not on its own eliminate AKS risk. As discussed above, AKS risk turns on intent, and the better practice for arrangements outside a safe harbor is to pair FMV with documentation of a legitimate business purpose that would hold up even without any referrals. For day-to-day compliance, the refreshed FAQs are a useful reminder. OIG looks at the circumstances and intent behind an arrangement.
McGuireWoods’ Healthcare Compliance, Regulatory & Policy attorneys continuously monitor OIG developments and guidance affecting the healthcare industry. For more information, contact one of the authors of this article.