The Department of Health and Human Services Office of Inspector General (OIG) has issued updates to its Frequently Asked Questions (FAQs) addressing the physician self-referral law (Stark Law), the federal anti-kickback statute (AKS), and the agency’s advisory opinion process. The updates, published April 23, 2026, include a revised FAQ addressing financial arrangement exceptions under the Stark Law (FAQ 4), a new FAQ addressing fair market value arrangements (FAQ 17), and additional guidance on changes to facts or laws after a favorable advisory opinion.
In the first updated FAQ, the OIG emphasizes that compliance with a Stark Law exception does not necessarily protect an arrangement from liability under the federal anti-kickback statute. The two laws serve different purposes and are analyzed under separate legal frameworks. The Stark Law is a strict liability statute, meaning intent is not required to establish a violation. In contrast, the anti-kickback statute requires a showing of knowing and willful intent.
As a result, even if a financial arrangement satisfies all elements of a Stark Law exception, it may still violate the anti-kickback statute if there is evidence that remuneration was intended to induce or reward referrals of federal healthcare program business. The OIG also reiterated that Stark Law exceptions and anti-kickback statute safe harbors are not interchangeable, even where they use similar terminology. Compliance with one does not establish compliance with the other.
By way of example, the OIG pointed to arrangements where providers offer items of value—such as entertainment or event tickets—to referral sources. Depending on the circumstances, such arrangements could potentially fit within a Stark Law exception for nonmonetary compensation. However, they are unlikely to qualify for protection under an anti-kickback statute safe harbor and may still raise concerns if intended to influence referrals.
In the second updated FAQ, the OIG addressed the role of fair market value in analyzing financial arrangements. The agency confirmed that while ensuring compensation is consistent with fair market value is an important compliance practice, it does not, by itself, prevent liability under the anti-kickback statute. The statute does not include a standalone exception for fair market value, and while some safe harbors require compensation to be consistent with fair market value, that is only one of several conditions that must be met.
The OIG cautioned against the assumption that fair market value alone eliminates risk. Instead, arrangements must be evaluated based on the totality of the facts and circumstances, including the intent of the parties. The agency reiterated its longstanding position that fair market value is a relevant consideration, but not a dispositive defense.
The third updated FAQ deals with guidance regarding the continued reliability of advisory opinions when underlying facts or laws change. Advisory opinions are based on the specific facts presented by the requestor and the legal framework in effect at the time the opinion is issued. If there are material changes to those facts, changes in applicable law, or differences in how the arrangement operates in practice, the protections associated with the advisory opinion may no longer apply.
In those situations, the OIG may modify or terminate the opinion. Providers who are concerned that changes could affect an existing advisory opinion may request a modification from the agency. While the OIG does not proactively monitor for such changes, it may revisit an opinion if it becomes aware of developments that could alter its original analysis.
The updated OIG FAQs can be accessed here (General Questions, including revised FAQ 4 and new FAQ 17) and here (Advisory Opinions, including a new FAQ addressing changes to facts or laws after a favorable opinion).
Compliance Perspective
Issue
Financial relationships with referral sources must be carefully structured and evaluated to ensure compliance with both the Stark Law and the AKS. As recent guidance from the OIG reiterates, compliance with a Stark Law exception or compensation at fair market value does not, by itself, ensure compliance with the anti-kickback statute. Arrangements that involve remuneration—even if consistent with fair market value—may still present risk if they are intended to induce or reward referrals of federal healthcare program business. Failure to properly evaluate these arrangements may result in significant civil and administrative penalties.
Discussion Points
- Review policies and procedures governing financial relationships, including arrangements with physicians, vendors, and other referral sources. Ensure policies address both Stark Law and AKS requirements, including documentation of fair market value and commercial reasonableness. Consider whether an independent third-party review or periodic compliance assessment may be appropriate to identify potential risk areas and strengthen existing protocols.
- Provide education and training to staff on the distinctions between the Stark Law and the AKS. Emphasize that compliance with fair market value standards or a Stark Law exception does not eliminate anti-kickback risk. Med-Net Academy offers the course Medical Director Contracts in a Nursing Facility, which addresses identification of the AKS, identification of the Stark Law, and key components required in a physician contract. This type of training helps reinforce appropriate contracting practices and supports compliance with applicable federal healthcare program requirements.
- Conduct periodic audits of financial arrangements and related documentation to assess compliance with applicable laws and internal policies. Review contracts, compensation structures, and any items of value provided to referral sources to ensure they are properly documented and consistent with regulatory requirements. Facilities may benefit from utilizing external compliance resources or mock review processes to evaluate risk areas and implement corrective actions before issues are identified through survey or enforcement activity. Contact Med-Net Healthcare Consulting or info@mednetconcepts.com for more information.
*This news alert has been prepared by Med-Net Concepts, Inc. for informational purposes only and is not intended to provide legal advice.*