The United States Attorney’s Office for the District of Massachusetts announced on July 15, 2026 that Laboratory Corporation of America (Labcorp), a national diagnostics testing laboratory, has agreed to pay $14.5 million to resolve allegations that it violated the False Claims Act by submitting medically unnecessary claims for urine drug testing (UDT) to Medicare for payment.
Labcorp offered clients a testing panel called “Toxassure Comprehensive,” which contained both “Presumptive” and “Definitive” testing methods. Generally, Presumptive UDT detects the presence or absence of certain drug classes subject to thresholds, while Definitive UDT identifies individual substances and their concentrations, where applicable. Medicare pays a flat rate for laboratory-based Presumptive UDT, regardless of the number of drug classes tested, and Medicare pays a flat rate for 22 or more drug classes tested under the Definitive method.
As part of the settlement, Labcorp reportedly admitted and accepted responsibility for the following facts:
- From January 1, 2018 through November 22, 2023, Labcorp routinely submitted claims to Medicare for Presumptive and Definitive UDT, some of which it submitted pursuant to a testing panel that Labcorp marketed as “ToxAssure Comprehensive.”
- ToxAssure Comprehensive consisted of a preselected combination of Presumptive UDT for certain substances and direct-to-Definitive UDT (i.e., with no prior Presumptive test) for other substances.
- Labcorp ran many of these tests simultaneously for the same patient, on the same date of service, using the same urine sample, and billed Medicare with CPT code 80307 for the Presumptive UDT and HCPCS code G0483 for the Definitive UDT. In other words, Labcorp billed Medicare for both the all-inclusive Presumptive code and the highest-tier Definitive code each time it performed the ToxAssure Comprehensive panel.
- For several of the substances tested on a direct-to-Definitive basis, a Presumptive testing option existed but Labcorp performed its Definitive tests without first performing a Presumptive test to determine the necessity of Definitive testing for that substance.
The government alleged that Labcorp’s conduct resulted in its billing Medicare for medically unnecessary UDT claims.
As part of the settlement, Labcorp represented that it ceased billing the combination of CPT code 80307 and HCPCS code G0483 for UDT using the ToxAsssure Comprehensive panel. Labcorp has been credited in this settlement under the Department of Justice’s guidelines for taking disclosure, cooperation and remediation into account in False Claims Act cases, Justice Manual §4-4.112.
If you have information regarding false claims having been submitted to Medicare, Medicaid, TRICARE, other federal health care programs, or to other federal agencies/programs, and the information is not publicly known and no actions have been taken by the government with regard to recovering the false claims, you should promptly consult with a False Claims Act attorney (also known as qui tam attorneys) in your U.S. state who may investigate the basis of your False Claims Act allegations and who may also assist you in bringing a qui tam lawsuit on behalf of the United States, if appropriate, for which you may be entitled to receive a portion of the recovery received by the U.S. government.
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