The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) maintains a set of Frequently Asked Questions (“FAQs”) addressing key issues under federal healthcare fraud and abuse laws. On April 23, 2026, the OIG updated its “General Questions Regarding Fraud and Abuse Authorities” FAQ page for the first time since July 2024, revising existing FAQ 4 and adding a new FAQ 17. The updates focus on the relationship between the Physician Self-Referral Law (“Stark Law”) and the federal Anti-Kickback Statute (“AKS”), with a particular emphasis on fair market value and intent. Although the revisions do not announce new law, they reinforce longstanding OIG interpretations and signal continued enforcement scrutiny of financial relationships involving physicians in areas related to marketing, gifts, and remuneration.
FAQ 4. Could a financial arrangement that satisfies a Stark Law exception violate the AKS?
Yes. Stark Law compliance does not confer AKS protection. In its revised FAQ 4, the OIG emphasizes that compliance with a Stark Law exception under 42 U.S.C. § 1395nn does not, by itself, shield a financial arrangement from liability under the AKS (42 U.S.C. § 1320a-7b(b)).
The OIG explains that the exceptions under the Stark Law and the exceptions and safe harbors under the AKS – even if they have similar titles, use similar terms, or include similar conditions – are distinct statutes that serve different purposes, prohibit different conduct, and impose different penalties. Notably, Stark Law is a strict liability statute, meaning that intent is generally irrelevant. By contrast, the AKS requires knowing and willful intent to offer, pay, solicit, or receive remuneration to induce or reward referrals of items or services reimbursable by a federal healthcare program. As a result, even where a financial relationship satisfies a Stark Law exception, parties may still face AKS liability if the facts and circumstances demonstrate improper intent for AKS purposes. As a result, an arrangement may satisfy a Stark Law exception yet still create AKS liability if it involves remuneration intended to induce or reward referrals for federal health care programs.
The takeaway is that AKS compliance remains highly fact-specific and depends on the totality of the circumstances and the parties’ intent. The example provided by the OIG focuses on gift giving practices, such as tickets to sporting and entertainment events, which underscores that marketing-related remuneration remains an area of enforcement interest, even where arrangements are structured to satisfy other regulatory requirements.
FAQ 17. Can fair market value arrangements violate the AKS?
Yes. The OIG reiterates that fair market value alone does not ensure AKS compliance. In the newly added FAQ 17, the OIG addresses a long-standing misconception in the healthcare industry that arrangements at fair market value and negotiated at arm’s length are inherently protected from AKS scrutiny. The OIG clarifies that structuring remuneration at fair market value is a best practice and may mitigate fraud and abuse risk, but alone does not protect an arrangement from AKS liability, which depends on the totality of the facts and circumstances, including the parties’ intent. Even where compensation is consistent with fair market value, an arrangement may still violate the AKS if one purpose of the remuneration is to induce or reward referrals. The AKS does not include a fair market value exception. Instead, as with FAQ 4, the OIG emphasizes that protection under a specific regulatory safe harbor turns on multiple conditions that must be met. Consistent with longstanding OIG guidance, fair market value is not a dispositive defense to AKS liability.
What does this mean for physicians and healthcare employers?
The April 2026 FAQ updates do not change the law, but they send a clear message that:
- Fair market value alone is not a guarantee of compliance.
- Stark Law compliance does not shield an arrangement from AKS risk.
- Intent and how an arrangement operates in practice matters.
The Anti‑Kickback Statute applies broadly and is not limited to healthcare providers; it can reach any individual or entity involved in arrangements related to federal health care program business.
Accordingly, compliance with both the Stark Law and the AKS is critical not only for physicians, medical practices, and hospitals, but also other healthcare employers, vendors, and business partners. While fair market value remains an important compliance benchmark, it is only one factor in a broader, fact-specific analysis. Arrangements involving physician compensation, marketing activities, gifts, and other forms of remuneration should be carefully evaluated under both the Stark Law and the AKS, with attention to how they operate in practice and the intent of the parties.
Healthcare organizations should continue to document fair market value and commercial reasonableness, avoid arrangements that could be perceived as inducing referrals, and regularly reassess marketing, gifting, and incentive practices. Ultimately, compliance cannot be reduced to checklists or valuations alone; it requires a case-by-case assessment grounded in the totality of the circumstances with careful attention to the parties’ intent and how arrangements operate in practice.
Leech Tishman Nelson Hardiman has extensive experience advising healthcare providers and provider entities on structuring compliant arrangements and navigating Stark Law and Anti-Kickback Statute compliance. We are prepared to assist clients in implementing compliance measures that reflect both regulatory requirements and OIG guidance. For assistance or additional information, please contact Tara Davidoff at tdavidoff@leechtishman.com or Nancy Lam at nlam@leechtishman.com, attorneys in Leech Tishman’s Healthcare Practice Group.