OIG Advisory Opinion: Lab Services and the Anti-Kickback Statute

The Office of Inspector General (OIG) at the Department of Health and Human Services (HHS) recently issued an advisory opinion clarifying the application of the Federal Anti-Kickback Statute to a specific arrangement involving an independent clinical laboratory and urgent care centers. The OIG determined the proposed arrangement did not pose a risk under the statute, offering guidance on structuring healthcare business relationships to avoid potential legal issues.

Understanding the Federal Anti-Kickback Statute

The Federal Anti-Kickback Statute prohibits the knowing and willful offer, payment, solicitation, or receipt of anything of value to induce or reward referrals of healthcare business payable by federal health care programs. As the OIG explains, this means rewarding referrals in healthcare is a crime, unlike in some other industries. Violations can lead to both criminal and civil penalties.

The Proposed Arrangement

The OIG reviewed a proposal from a management entity affiliated with four urgent care centers. This entity planned to operate an independent clinical laboratory as a separate legal entity. Key aspects of the arrangement included:

• The laboratory would provide testing services to the urgent care centers but would not be located on their premises.
• The laboratory would not be owned or operated by individuals with referral authority.
• The laboratory would directly bill payors, including federal health care programs, and not bill the urgent care centers.
• Patients would be informed of the relationship and offered the choice of using an unaffiliated laboratory.

Key Certifications and OIG Analysis

The OIG’s favorable opinion hinged on several certifications made by the requestor. These assurances were critical in demonstrating the arrangement’s compliance with the Anti-Kickback Statute:

• No compensation to providers or suppliers at the urgent care centers would be tied to test volume or value.
• No remuneration would flow from the laboratory to the urgent care centers or their providers.
• The laboratory would not offer or pay for specimen referrals.
• The urgent care centers’ electronic health record system would allow orders from multiple laboratories without preference.
• The laboratory would only accept specimens consistent with payor contracts and patient insurance coverage.

The OIG emphasized that the absence of remuneration intended to induce referrals was the defining factor. As highlighted by the OIG, arrangements involving kickbacks, such as sham investment opportunities or consulting arrangements, would be problematic if they aimed to incentivize referrals.

Recent OIG Guidance on Pharmaceutical DTC Sales

In January 2026, the OIG issued a Special Advisory Bulletin addressing the application of the Anti-Kickback Statute to direct-to-consumer (DTC) prescription drug sales by manufacturers. This bulletin requests information on potential safe harbors to address industry concerns regarding DTC drug sales, signaling a willingness from the administration to explore paths toward lower-cost prescription drugs. Revisions to safe harbors under the Anti-Kickback Statute are also being considered.

OIG Exceptions and Safe Harbors

The OIG has established numerous exceptions to the Anti-Kickback Statute, allowing for certain arrangements that might otherwise be considered problematic. These exceptions, known as safe harbors, provide protection from penalties when specific conditions are met.

Important Considerations

This advisory opinion is specific to the facts presented and should not be relied upon as a general endorsement of similar arrangements. Healthcare entities considering similar structures should consult with qualified legal counsel to ensure compliance with all applicable laws and regulations.