Labcorp will pay $14.5M after admitting it billed 80307 and G0483 on the same urine sample
Labcorp admitted billing CPT 80307 and HCPCS G0483 on the same urine sample, same day, in a $14.5 million False Claims Act settlement. If you run a standing tox panel, that's the pair DOJ named.
Reviewed by Jess P., CPC
Published July 19, 2026
Key Takeaways
- →Labcorp agreed on July 15, 2026 to pay $14,500,000 to resolve False Claims Act allegations over urine drug testing billed to Medicare Part B under its ToxAssure Comprehensive panel.
- →Labcorp admitted that between January 1, 2018 and November 22, 2023 it routinely submitted presumptive and definitive urine drug testing claims to Medicare, and that each time its ToxAssure Comprehensive panel ran it billed CPT 80307 and HCPCS G0483 on the same patient, same date of service, from the same urine sample.
- →During the 2018 to 2023 conduct period, Medicare paid a flat rate for laboratory-based presumptive testing under CPT 80307 regardless of the number of drug classes, and in general paid the highest bundled definitive rate under HCPCS G0483 for 22 or more drug classes with no additional payment beyond 22.
- →The United States alleged the ToxAssure Comprehensive panel produced medically unnecessary claims for some of the patients who received it, and DOJ states the resolved claims are allegations only with no determination of liability.
- →Labcorp represented in the settlement agreement that it has ceased billing Medicare the CPT 80307 and HCPCS G0483 combination for beneficiaries tested with the ToxAssure Comprehensive panel.
Labcorp admitted it billed CPT 80307 and HCPCS G0483 together, on the same patient, same date of service, from the same urine sample. That admission sits inside a $14,500,000 False Claims Act settlement the Justice Department announced on July 15, 2026, covering urine drug testing billed to Medicare Part B under a panel Labcorp marketed as ToxAssure Comprehensive.
What Labcorp admitted, in its own settlement
The settlement agreement has a paragraph where Labcorp "admits, acknowledges, and accepts responsibility" for a specific set of facts. Everything the government says about why that billing was improper is allegation.
From January 1, 2018 through November 22, 2023, Labcorp routinely submitted presumptive and definitive urine drug testing claims to Medicare, and some of that testing ran under the ToxAssure Comprehensive panel. The panel was a preselected combination: presumptive testing for certain substances, and direct-to-definitive testing, with no presumptive test first, for others.
Each time the panel ran, Labcorp billed 80307 for the presumptive work and G0483 for the definitive work, from one specimen on one DOS. For several substances tested direct-to-definitive, a presumptive option existed and Labcorp went straight to definitive without running it.
What the government alleged, and what nobody decided
Everything above is admitted. The conclusion drawn from it is not.
The United States alleged that the full panel, billed that way, produced medically unnecessary claims to Medicare for some of the patients who received it. DOJ's release closes with the standard line that the claims resolved by the settlement are allegations only and there has been no determination of liability.
That's the part you'll need if anyone asks. The billing pattern is established. Whether any given panel was medically unnecessary was never adjudicated, and the government said some of the patients, not all of them.
How Medicare paid for urine drug testing during the conduct period
The settlement agreement lays out the payment structure the conduct sat on top of. It describes the rates in effect from 2018 through 2023, so confirm the current fee schedule before you apply any of it to a live claim.
| Code | What it covered | How Medicare paid |
|---|---|---|
| CPT 80307 | Laboratory-based presumptive testing | Flat rate per patient, regardless of how many drug classes were tested and billed |
| HCPCS G0480 | Definitive, 1 to 7 drug classes | Bundled rate by drug-class tier |
| HCPCS G0481 | Definitive, 8 to 14 drug classes | Bundled rate by drug-class tier |
| HCPCS G0482 | Definitive, 15 to 21 drug classes | Bundled rate by drug-class tier |
| HCPCS G0483 | Definitive, 22 or more drug classes | Highest of the bundles, and in general no more for classes tested beyond 22 |
Read the two ends of that table together. Presumptive paid the same no matter how wide the testing went, and definitive topped out at G0483. A standing panel that always landed on both put every patient at the ceiling of both.
Where the exposure actually sits
Neither primary document says the codes themselves are the problem. The settlement describes 80307 and G0483 as the presumptive and top-tier definitive bundles Medicare paid during the relevant period, and the government's stated concern is the panel. Coverage rules for urine drug testing sit with your MAC, and this settlement doesn't change them.
What the government described is a combination that was preselected rather than decided per patient. When the same panel fires for everyone, the per-patient decision stops being something the record captures. You end up defending the claim on a record that never says why definitive testing was ordered for this substance, which is the same gap behind a lot of insufficient-documentation denials, just in a different code family.
Labcorp represented in the settlement that it has stopped billing Medicare the 80307 and G0483 combination for beneficiaries tested with ToxAssure Comprehensive.
Where this lands on a coder's desk
This is a Part B lab medical-necessity matter, not a risk-adjustment case, so nothing here touches your HCC mappings or RAF weights. It lands on anyone touching tox claims in pain management, behavioral health, or addiction medicine. Also on whoever owns the standing order sets.
The self-audit is small, and it ends in a judgment call the claim data can't make for you. Once you've got the flagged dates, the only question left is what the ordering note says about why this substance, this patient. If the answer is the panel name, you don't have a record, and a compliant provider query before the claim goes out beats an appeal after it. When you're reconstructing who ordered what, the NPI lookup covers the entity side.
The rest of the numbers
Of the $14,500,000, $8,286,000 is restitution, and interest runs on top of that amount at 4.5 percent per annum from May 14, 2025. DOJ credited Labcorp under Justice Manual section 4-4.112 for disclosure, cooperation, and remediation.
Neither the DOJ release nor the settlement agreement names a relator or mentions a Corporate Integrity Agreement.
The same shape as the diagnosis-side cases
Strip the codes out and the structure is familiar from the risk-adjustment matters. A repeatable process produces billable output and applies to everyone the same way, and the per-patient justification lives in the process instead of the record. The government described a similar shape on the diagnosis side in the Matrix and HealthFair settlement.
What coders should do now
- 1Pull a week of urine drug testing claims, flag any DOS where CPT 80307 and HCPCS G0483 were both billed from the same specimen, and confirm the definitive drug-class count on the claim matches what was actually tested.
- 2For every definitive test billed on a substance where a presumptive option exists, check whether a presumptive test was run first, and whether the note says why it was skipped.
- 3Read your standing tox order sets and confirm the panel composition is selectable per patient rather than preselected for everyone.
- 4Check that the ordering note documents medical necessity for this patient and this substance, and not just the panel name.
- 5When you find the pair with no per-patient rationale in the note, query the ordering provider before the claim goes out rather than after.
Frequently Asked Questions
Did DOJ say billing CPT 80307 and HCPCS G0483 on the same day is prohibited?
No. Neither the DOJ release nor the settlement agreement says the code pair is improper. What Labcorp admitted is that it billed both from the same specimen every time the ToxAssure Comprehensive panel ran, and what the United States alleged is that the full panel produced medically unnecessary claims for some of the patients who received it. The claims were resolved as allegations with no determination of liability. Coverage rules for urine drug testing sit with your MAC, and this settlement does not change them.
Did Labcorp admit wrongdoing in the settlement?
Labcorp admitted, acknowledged, and accepted responsibility for a set of billing facts: that between January 1, 2018 and November 22, 2023 it routinely submitted presumptive and definitive urine drug testing claims to Medicare, that for the tests run under its ToxAssure Comprehensive panel it ran both simultaneously from the same urine sample on the same date of service and billed CPT 80307 and HCPCS G0483, and that some definitive tests were run direct-to-definitive where a presumptive option existed. It did not admit the claims were medically unnecessary. That stayed an allegation.
Does the Labcorp settlement change anything for HCC or risk adjustment coding?
No. It resolves Medicare Part B laboratory claims under CPT 80307 and HCPCS G0483, so it does not change any ICD-10-CM to HCC mapping, any RAF weight, or any risk adjustment submission rule. The transferable lesson is about documenting medical necessity per patient rather than per protocol.
What does direct-to-definitive urine drug testing mean?
Direct-to-definitive means a definitive test identifying a specific substance and its concentration is performed without first running a presumptive test to indicate whether that substance is present. Labcorp admitted that for several substances in the ToxAssure Comprehensive panel, a presumptive option existed and the definitive test was performed without it.
Sources
Related Tools
Jess P., CPC
Certified Professional Coder
Jess reviews HCC Buddy editorial content for accuracy against the current CMS-HCC model and the active FY ICD-10-CM tabular release.
Get CMS Updates in Your Inbox
RADV news, model changes, and coding guidance — within days of CMS publishing, not quarters.
More from CMS Watch
Aetna pays $117.7M to settle FCA case over one-way chart reviews and unsupported obesity codes
June 6, 2026
FCA SettlementMatrix and HealthFair pay $56.5M over in-home assessment diagnoses the records didn't support
June 6, 2026
FCA SettlementKaiser's $556M FCA Settlement: What the Addenda and Query Allegations Mean for Working Coders
June 5, 2026