New OIG Guidance Addresses Common Stark Law Misconceptions

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7/1/2026

In April 2026, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) updated its fraud and abuse FAQs to address certain common misconceptions regarding the relationship between the federal physician self-referral law (Stark Law) and the federal Anti-Kickback Statute (AKS). In its revised guidance, the OIG emphasized that compliance with a Stark Law exception does not insulate an arrangement from AKS liability. According to the guidance, because the AKS is intent-based and the Stark Law is a strict liability statute, a financial arrangement may satisfy all of the elements of a Stark exception yet still violate the AKS, depending on the parties’ intent and the surrounding facts.

The OIG also clarified that fair market value alone is not determinative of AKS compliance. While fair market value and commercial reasonableness are relevant considerations, they represent only part of the analysis, and do not substitute for meeting all elements of an applicable safe harbor or otherwise ensuring that remuneration is not intended to induce referrals, including requirements related to compensation structure, documentation, and the volume or value of referrals. These updates serve as a reminder that providers should not rely solely on Stark Law compliance or fair market value in assessing fraud and abuse risk, and must instead ensure that arrangements satisfy both an applicable Stark Law exception and an Anti-Kickback Statute safe harbor.

For more information, contact:
Carol Grelecki | 973.403.3140 | cgrelecki@bracheichler.com
Jonathan J. Walzman | 973.403.3120 | jwalzman@bracheichler.com
Rebecca T. Falk | 973.364.8393 | rfalk@bracheichler.com

*This is intended to provide general information, not legal advice. Please contact the authors if you need specific advice.

Jonathan J. Walzman

Member
Healthcare Law, Corporate Transactions & Financial Services

973.403.3120 · 973.618.5561 Fax

Related Practices:   Healthcare Law

Related Industry:   Healthcare