A Missouri laboratory and three of its owners have agreed to pay the United States $13,619,660.18 to resolve allegations that they violated the False Claims Act by submitting or causing the submission of claims to Medicare for lab tests that were not ordered by healthcare providers and were not medically necessary. Additionally, the three owners agreed to a 15-year exclusion from participating in federal healthcare programs.
The settlement, announced on March 27, 2024, resolves allegations that, from Jan. 1, 2020, to Oct. 31, 2020, the lab and the three owners submitted or caused to be submitted claims to Medicare for medically unnecessary polymerase chain reaction (PCR) urinalysis laboratory tests that were not ordered by treating physicians.
When a physician requested a urinalysis (UA) with culture and sensitivity (C&S) or just a C&S, the lab automatically performed UTI PCR Tests, submitting claims for payment to Medicare. The UTI PCR Tests brought significantly higher reimbursements than a UA with C&S. On average, Medicare paid approximately $11 for a UA with C&S, but an additional $573 for a panel of UTI PCR Tests.
The lab’s requisition forms didn’t provide an option for physicians to opt out of the UTI PCR Tests. Physicians voiced concerns to the lab as early as March 2020, including objections that they hadn’t ordered the tests, that they were costly, and that they weren’t medically necessary.
“Healthcare providers who cause the submission of Medicare claims for medically unnecessary services pose a significant risk to the program and the patients who rely on it,” said Special Agent in Charge Linda Hanley of the Department of Health and Human Services, Office of Inspector General (HHS-OIG). “HHS-OIG works diligently with our law enforcement partners to hold accountable individuals who, to satisfy their own greed, exploit federal healthcare programs.”
Compliance Perspective
Issue
Providers must ensure that the claims they submit to Medicare and Medicaid are true and accurate. One of the most important steps a provider can take is to have a robust internal audit program that monitors and reviews claims. If a provider identifies billing mistakes in the course of those audits, the provider must repay overpayments to Medicare and Medicaid within 60 days to avoid False Claims Act liability. Staff should also understand their responsibility to identify and report concerns of utilization of any services that they believe are unnecessary or inappropriate for a resident, to include ordered tests, procedures, treatments, therapies, and medications.
Discussion Points
- Review your policies and procedures on ensuring that all provided resident services are reasonable and necessary, and for prevention of false claims. Ensure that your policies are reviewed at least annually and updated when new information becomes available.
- Train all staff upon hire and at least annually on your compliance and ethics policies and procedures and on what can be considered a false claim. Provide training to appropriate staff on the Triple Check Process for ensuring accuracy of all Medicare Part A billing and supporting documentation before claims are submitted. Ensure appropriate staff monitor for potential false claims related to unnecessary or inappropriate services that are unsupported by documentation. Include information on how to report concerns and suspected violations, and that prompt reporting is mandatory. Document that these trainings occurred and file the signed document in each employee’s education file.
- Periodically audit medical records to ensure that all services provided to residents are reasonable and necessary. Also periodically audit to ensure staff are aware of compliance and ethics concerns and understand their responsibility to report any potential violations to their supervisor, the compliance and ethics officer, or via the anonymous hotline.
*This news alert has been prepared by Med-Net Concepts, LLC for informational purposes only and is not intended to provide legal advice.*
