OIG Reaffirms: Fair Market Value Alone Does Not Eliminate Anti-Kickback Statute Risk

By Lisa Damhof

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. The update included the addition of Question #17: “Can fair market value arrangements violate the Federal anti-kickback statute?” The OIG’s answer is a clear “yes.” 

Reaffirming a Longstanding Position: FMV Is Not a Shield from AKS Liability

OIG’s guidance reiterates its longstanding and established position that, while it is a compliance best practice to ensure that compensation is consistent with fair market value (FMV), in itself, FMV does not shield an arrangement from Anti-Kickback Statute (AKS) liability. An arrangement may violate the AKS even if remuneration is consistent with FMV where the facts and circumstances, including the parties’ intent, indicate that at least one purpose of the remuneration is to induce or reward referrals or other federal health care program business. 

OIG’s guidance also emphasizes that the AKS does not include an exception or safe harbor protecting remuneration because it is consistent with FMV. Compensation at fair market value alone does not eliminate AKS risk; safe harbor protection requires compliance with all applicable safe harbor elements. Several AKS safe harbors require compensation to be consistent with FMV, but FMV is only one of multiple conditions. To qualify for protection, each stream of remuneration must satisfy every requirement of the applicable safe harbor. Failure to satisfy all applicable safe harbor conditions leaves an arrangement subject to enforcement risk based on the totality of its facts and circumstances, including the parties’ intent.

Practical implications of Question #17

Healthcare organizations should not rely solely on FMV opinions or valuation analyses when structuring arrangements with potential referral sources. OIG has reiterated that AKS compliance requires a broader facts-and-circumstances analysis. 

“OIG’s guidance in the new Question #17 serves as a reminder that while FMV is an important compliance consideration, it is not a standalone defense to liability under AKS. OIG is restating that AKS risk depends on the totality of the facts and circumstances, and whether all elements of an applicable safe harbor are met. Companies should continue to assess and document FMV, but they should also evaluate the broader structure, purpose, and operational realities of their arrangements.” 

Lisa Damhof, Associate Attorney

For manufacturers and other life science companies, OIG’s guidance in Question #17 underscores the importance of: 

• Documenting legitimate business purposes;
• Ensuring compensation arrangements are not intended to induce or reward referrals or utilization of federally reimbursable items or services; 
• Evaluating whether the arrangement has a legitimate and commercially reasonable purpose independent of generating referrals or other federal health care program business and structure; and
• Maintaining robust compliance controls and oversight of compensation arrangements to confirm that services are legitimate, necessary, and actually performed and that compensation methodologies do not create inappropriate referral, ordering, or steering incentives.  

How Gardner Law can help

Gardner Law regularly advises medical products companies on AKS and FMV compliance issues. Our team helps clients evaluate compensation arrangements, physician relationships, and other financial arrangements to identify and mitigate AKS risk beyond FMV analyses alone.