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United States of America v. Laboratory Corporation of America (Labcorp)
Date: 07-16-2026
Case Number:
Judge: Nnone
Court: United States District Court for the District of Massachusetts (Suffolk Count)
Plaintiff's Attorney: Abraham R. George and Augustine Ripa
Defendant's Attorney:
Click Here For The Best Boston Civil Litigation Lawyer Directory
Description:
Boston, Massachusetts, Department of Justice lawyers represented the United Stare on a False Claims Act claim that the Defendant submitted 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 announced today, Labcorp admitted and accepted responsibility for the following facts.
From Jan. 1, 2018, through Nov. 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 alleges that Labcorp’s conduct resulted in its billing Medicare for medically unnecessary UDT claims.
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 announced today, Labcorp admitted and accepted responsibility for the following facts.
From Jan. 1, 2018, through Nov. 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 alleges that Labcorp’s conduct resulted in its billing Medicare for medically unnecessary UDT claims.
Outcome:
Settled for $14.5 million.
Plaintiff's Experts:
Defendant's Experts:
Comments:
About This Case
What was the outcome of United States of America v. Laboratory Corporation of Ame...?
The outcome was: Settled for $14.5 million.
Which court heard United States of America v. Laboratory Corporation of Ame...?
This case was heard in United States District Court for the District of Massachusetts (Suffolk Count), MA. The presiding judge was Nnone.
Who were the attorneys in United States of America v. Laboratory Corporation of Ame...?
Plaintiff's attorney: Abraham R. George and Augustine Ripa. Defendant's attorney: Click Here For The Best Boston Civil Litigation Lawyer Directory.
When was United States of America v. Laboratory Corporation of Ame... decided?
This case was decided on July 16, 2026.