Laboratory Corporation of America (Labcorp), a national clinical diagnostics company, has agreed to pay $14,500,000 to resolve allegations that it violated the False Claims Act by submitting false claims to Medicare Part B (Medicare) for medically unnecessary urine drug testing for some patients conducted pursuant to a testing panel offered by Labcorp, called “Toxassure Comprehensive”.
Labcorp’s Toxassure Comprehensive panel contained both “Presumptive” and “Definitive” UDT methods. In general, Presumptive UDT detects the presence or absence of certain drug classes at specific testing thresholds, while definitive UDT identifies individual substances and their concentrations, where applicable.
Medicare payment for UDT is based on bundled payment rates associated with the Current Procedure Terminology (CPT) or Healthcare Common Procedure Coding System (HCPCS) codes.
In general, for laboratory-based presumptive testing, Medicare pays a flat rate regardless of the number of drug classes tested, pursuant to CPT code 80307, and for definitive testing, Medicare pays a flat rate for 22 or more drug classes per HCPCS Code G0483.
As part of the settlement, Labcorp admitted, acknowledged, and accepted responsibility that from January 1, 2018, through November 22, 2023, Labcorp routinely submitted claims for presumptive and definitive UDT to Medicare, some of which were submitted pursuant to a testing panel marketed by Labcorp as “ToxAssure Comprehensive”.
ToxAssure Comprehensive...
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