IRVING, TEXAS – Inform Diagnostics, Inc. (Inform), a clinical laboratory based in Irving, Texas, has agreed to pay $2.9 million to resolve potential False Claims Act violations tied to conduct that allegedly violated the Anti-Kickback Statute (AKS). This settlement stems from a series of test arrangement practices that led to the submission of false claims for reimbursement under Medicare and other federal health care programs.
The U.S. government alleged that Inform submitted false claims to these programs, violating the Anti-Kickback Statute, particularly through arrangements known as Test Arrangements (PTAs) with physician practices from 2018 to 2023.
Inform Dx is a company that provides anatomic pathology services. Since 1996, they provide services to both clinicians and patients. Headquartered in Coppell, Texas, they have grown to become one of the nations largest national outpatient pathology laboratory. They center their strengths on rigorous quality assurance processes, experience and expertise.
From 2018 to 2023, Inform engaged in a practice known as “purchase test arrangements” (PTAs) with a small group of its physician practice customers. Under these arrangements, Inform’s customers would perform one component of an anatomic pathology (AP) service and refer the other component to Inform for completion. Inform would then bill commercial insurers for both components and reimburse the customer at a set price. The practice also led to the submission of claims for services that were ultimately billed to Medicare and other federal health care programs. The U.S. government contended that these PTAs violated the AKS, tainting the claims submitted for payment.
The settlement follows Inform’s voluntary self-disclosure of the conduct to the U.S. Attorney’s Office earlier this year, including an internal investigation that outlined the problematic relationships and the potential financial impact on the government. Inform has since terminated all of its PTAs.
The settlement resolves civil claims under the False Claims Act but excludes certain liabilities, such as criminal actions or claims for conduct outside the covered period. Inform also agreed to not seek payment for these claims from beneficiaries and to correct prior cost reports that included unallowable costs. The agreement is governed by U.S. law, and Inform has waived certain legal defenses related to potential criminal or administrative actions.
“We commend Inform for its decision to self-disclose this conduct to the government,” said U.S. Attorney Joshua S. Levy. “By coming forward, Inform saved itself hundreds of thousands of dollars, which is an incentive for other companies to take similar steps when faced with potential violations of the law.”
The $2.9 million settlement includes $1.98 million in restitution, along with interest on the total amount. As part of the agreement, Inform has also committed to not seeking payment from federal health care beneficiaries or their third-party payors for any services related to the conduct covered by the agreement.
Although the settlement resolves civil claims, it does not release Inform from potential criminal liability or any other claims that may arise from unrelated conduct. The U.S. Department of Justice has emphasized that Inform’s voluntary cooperation in disclosing the violations and its subsequent corrective actions were key factors in achieving this resolution.
Key provisions of the agreement include Inform’s obligation to pay the settlement amount, which covers restitution and interest, within 10 days of the agreement’s effective date. The settlement resolves most civil claims related to false claims under the False Claims Act, with certain exceptions, such as criminal liability and claims arising from other conduct. Inform must also identify and adjust any previously submitted cost reports that included unallowable costs, such as payments made under the PTAs, and the government will recoup any overpayments. Additionally, Inform agrees not to seek reimbursement from patients or third-party payers for the claims covered by the settlement. Lastly, Inform is required to terminate its PTAs and refrain from resubmitting or appealing any previously denied claims related to these arrangements.
The settlement is a part of ongoing efforts by the U.S. government to enforce the Anti-Kickback Statute, which aims to prevent financial incentives from influencing decisions in federal health care programs, including Medicare.
The case was handled by U.S. Attorney Joshua S. Levy and Assistant U.S. Attorneys Abraham R. George and Alexandra Brazier. Special agents from the U.S. Department of Health and Human Services and the Defense Criminal Investigation Service also participated in the investigation.
