Federal health regulators are pushing back on two widespread assumptions that have long given healthcare executives a false sense of security: that complying with the Stark law is enough to stay out of trouble under the Anti-Kickback Statute, and that paying fair-market value makes a financial arrangement untouchable, according to a pair of updated FAQs released April 23 by the HHS Office of Inspector General.
Here are eight things to know:
1. The FAQs emphasize that satisfying a Stark law exception does not automatically shield an arrangement from anti-kickback liability. The two statutes have different frameworks, goals and standards.
2. According to a blog post from Snell & Wilmer, the Stark law is a strict liability statute where intent is irrelevant, while the anti-kickback law requires knowledge of and willful intent to induce or reward referrals.
3. According to a blog post from Holland & Knight, paying fair market value does not, by itself, protect an arrangement under the anti-kickback law. The blog post notes the term “fair-market value” doesn’t even appear in the statute itself, only in certain safe harbors as one of many required elements.
4, Anti-Kickback Statute safe harbor protection requires satisfying each and every condition of the applicable safe harbor. FMV is just one piece of that puzzle, and organizations that focus on it exclusively risk overlooking other required elements, including commercial reasonableness.
5. Nonmonetary benefits carry special anti-kickback law risk. The OIG specifically flagged sporting event tickets as an example: Such gifts may fall within Stark law’s nonmonetary compensation exception, currently capped at $535 per physician for 2026, but there is no equivalent anti-kickback law safe harbor. If referral intent is present, liability can follow.
6. Analysis of anti-kickback law is always facts-and-circumstances specific, according to Holland & Knight. Even if remuneration looks clean on its face, the totality of the circumstances, including the parties’ intent and the arrangement’s business purpose, ultimately determines liability.
7. Fair-market value documentation alone is not enough. Best practice requires documenting not just that compensation reflects fair market value, but also that the arrangement serves a legitimate, independent business purpose that would withstand scrutiny even absent any referral relationship, according to Holland & Knight.
8. For novel or borderline situations, the advisory opinion process is the only mechanism that provides binding, arrangement-specific protection, which is a meaningful distinction given that these FAQs themselves carry no legal force.
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