The United States has filed a complaint under the False Claims Act against a company that provides medical billing and compliance services, alleging that it submitted or caused the submission of false claims to Medicare for medically unnecessary genetic laboratory tests.
The announcement was made on June 3, 2025, by US Attorney Hayden P. O’Byrne for the Southern District of Florida and Acting Special Agent in Charge Jesus Barranco of the US Department of Health and Human Services, Office of Inspector General (HHS-OIG). Assistant US Attorney Clarissa Pinheiro is handling the case, with HHS-OIG conducting the investigation.
The defendant, registered as a Florida limited liability company, offers medical billing and compliance services in the United States. Its CEO was based in the United Kingdom, its employees were based in India, and it provided services to customers in the United States, including submitting Medicare claims on behalf of healthcare providers and suppliers. The United States’ claims arise from the company’s alleged conduct in offering Medicare billing advice and submitting claims on behalf of a Miami-based diagnostic laboratory.
The United States contends that from August 2018 through August 2019, the company billed Medicare Part B approximately $15,178,946.00 for genetic tests on behalf of the laboratory, even though the company knew or should have known that the tests were not medically necessary and were not ordered by the beneficiaries’ treating physicians. As a result, the laboratory received Medicare funds to which it was not entitled and, correspondingly, paid the company for its services.
Compliance Perspective
Issue
Medicare does not cover the costs of genetic tests that are not reasonable and necessary for the diagnosis or treatment of illness. To be covered by Medicare, a diagnostic laboratory test, including a genetic test, must be ordered by the physician who is treating the beneficiary for a specific medical condition and who uses the results in the management of that condition. The False Claims Act provides a way for the government to recover funds when someone submits, or causes the submission of, false or fraudulent claims for payment to the government, including to Medicare and Medicaid. For False Claims Act violations, a provider may be liable for up to three times the government’s loss, plus a penalty of up to $11,000 per claim. These penalties can add up quickly, as each individual claim for payment may constitute a separate violation.
Discussion Points
- Review your policies and procedures for preventing and reporting false claims. Ensure they include appropriate safeguards for Medicare Part B billing, such as verifying medical necessity, confirming physician orders, and maintaining accurate documentation. Policies should be reviewed at least annually and updated as new regulations or guidance become available.
- Train all staff upon hire and at least annually on your compliance and ethics policies, including what may constitute a false claim. Provide targeted training to staff involved in billing or coding for Medicare Part B services, with an emphasis on documentation, claim accuracy, and regulatory requirements. Compliance and ethics committee members should receive periodic training on emerging risks and enforcement trends.
- Conduct regular audits to verify that staff understand their responsibilities and follow proper procedures for identifying and reporting potential compliance issues. For Medicare billing, conduct regular audits to detect and correct errors before claims are submitted. Ensure audit findings are documented, and any identified issues are promptly addressed.
*This news alert has been prepared by Med-Net Concepts, Inc. for informational purposes only and is not intended to provide legal advice.*