By: Christopher Parrella, Esq., CPC, CHC, CPCO
Parrella Health Law, Boston, Ma.
A Health Care Provider Defense and Compliance Firm

In a significant compliance case, Inform Diagnostics, a Texas-based clinical laboratory, has agreed to pay $2.9 million to resolve allegations of violating the False Claims Act (FCA) through practices that breached the Anti-Kickback Statute (AKS). This case underscores both the risks of non-compliance and the value of proactive self-disclosure when potential violations occur.

What Happened?

From 2018 to 2023, Inform Diagnostics engaged in Purchased Test Arrangements (PTAs) with certain physician practice customers. These PTAs involved splitting the technical and professional components of anatomic pathology (AP) services. Inform billed commercial insurers for both components, reimbursing customers for their contributions. The United States alleged that these practices incentivized referrals for additional services billed to Medicare and other federal programs, violating the AKS and leading to false claims under the FCA.

Upon conducting an internal investigation in late 2023, Inform voluntarily reported its findings to the U.S. Attorney’s Office. This self-disclosure included detailed accounts of the PTAs, their financial impact on federal programs, and the immediate termination of the PTAs.

The Settlement Agreement

The agreement highlights several key points:

• Financial Penalty: Inform will pay $2.9 million, including $1.97 million in restitution.
• Cooperation Credits: Inform received favorable consideration under the Department of Justice’s Voluntary Disclosure Guidelines for its transparency and cooperation during the investigation.
• Compliance Assurance: Inform has ceased all PTAs and pledged adherence to rigorous compliance protocols moving forward.

Key Takeaways

1. The Cost of Non-Compliance: Violations of the AKS carry severe financial and reputational consequences. For Inform, the improper financial arrangements translated into costly litigation and settlement.
2. The Value of Self-Disclosure: By coming forward before federal authorities were aware of the violations, Inform mitigated its liability and avoided a protracted investigation. U.S. Attorney Joshua Levy emphasized that self-disclosure saves time and resources for both the company and the government, offering a tangible incentive for transparency.
3. Compliance as a Strategic Imperative: Companies in healthcare must routinely assess their business practices to ensure compliance with the FCA, AKS, and other federal regulations. Ignorance of the law is no defense, and internal audits are essential for identifying potential issues before they escalate.

Final Thoughts

The Inform Diagnostics case serves as a reminder that compliance is not merely a legal obligation—it’s a business imperative. For healthcare providers, the risks of AKS violations extend beyond financial penalties to include reputational harm and potential exclusion from federal healthcare programs.

If you have questions about compliance in healthcare or need assistance navigating complex regulations like the AKS or FCA, contact Parrella Health Law at 857.328.0382 or reach out to Chris directly at cparrella@parrellahealthlaw.com. Your compliance strategy today could safeguard your business tomorrow.