Specimen Validity Testing Billing: When Creatinine and pH Are Already Included

For specimen validity testing billing, Medicare does not pay a separate charge for chemistry checks performed as quality control with a urine drug test. Creatinine, pH and specific gravity can help a laboratory assess the specimen it is testing. Charging separately for that work turns part of the drug-testing service into another bill. If you work at the bench, in billing or with laboratory orders, the question is familiar: did the clinician need a separate test for the patient’s care, or did the lab need to check the urine?

Can Specimen Validity Testing Be Billed Separately?

Medicare does not separately pay for specimen validity testing performed as quality control with a urine drug test.

The distinction starts with what the result tells the laboratory. A drug screen looks for drugs or drug classes. A validity check examines the specimen: whether it has been diluted, replaced or altered in a way that affects the drug result. The laboratory may need that information to interpret its work. The separate billing question is whether Medicare already includes that work in the drug-testing service.

The Office of Inspector General’s audit of combined validity and urine drug-test billing preserved the distinction. Officials at the Centers for Medicare & Medicaid Services told the auditors that medically necessary tests for other conditions, performed on the same day as a urine drug test for the same patient, should be rare. The reason for the test matters more than the name on the result.

Why Creatinine and pH Are Already Included

When a laboratory bills specimen validity as separate chemistry tests, the extra claim separates quality-control work from the drug-testing service it supports. Creatinine has its own code, 82570, and pH has its own code, 83986. Having a code doesn’t make a specimen check a second service.

That is how a fee schedule can mislead someone looking at the laboratory’s test menu. A listed test and a listed price look like another service the business can sell. But the payment question follows the purpose of the work. We see the absurdity in treating the same specimen check as both part of a drug test and an extra product to charge for.

The rule also predates the audit. In its LabTox settlement announcement, the Justice Department said Medicare guidance had explicitly prohibited separate specimen validity billing since January 2014. The Inspector General later described a payment-system edit introduced in April 2016 to prevent improper combinations.

The drug-testing claim has its own code family: 80305 through 80307 for presumptive testing, and G0480 through G0483 and G0659 for definitive testing. The separate chemistry line is the extra charge at issue here.

Urine Creatinine, Specific Gravity and pH on a Separate Medicare Claim

A separate Medicare claim for urine creatinine, specific gravity or pH can expose a mismatch between the order and the bill: the clinician requests drug monitoring, but the laboratory bills the specimen check as another clinical test.

That mismatch runs through different people’s records. The clinician keeps the medical justification in the patient’s chart. The laboratory keeps the information it received and the information it submitted with the claim. The bench result answers what was measured. The order and clinical record answer why.

The person who knows why the laboratory measured creatinine may see what the claim leaves out. We examine the connection between the request, the specimen result and the extra charge with you. The point is to understand how the billing acquired a purpose the underlying work did not have.

The diagnosis information matters for the same reason. Medicare requires a laboratory’s claim to reflect diagnostic information supplied by the ordering clinician. The claim’s explanation for a test should lead back to a medical decision, not merely to a code that gets paid.

LabTox Put the Method and the Extra Charge in the Same Case

LabTox agreed in November 2019 to pay $2,101,335 to resolve False Claims Act allegations involving urine drug testing. The health care fraud allegations reached both the testing method and the extra specimen check.

First, the United States alleged that LabTox billed Medicare and Kentucky Medicaid for high-complexity qualitative urine drug screens even though it used a low-complexity method. The alleged mismatch increased reimbursement. Separately, the government alleged that LabTox billed Medicare for specimen validity testing from January 2014 through February 2016, despite the explicit guidance against separate billing.

Those allegations reach different parts of the laboratory. The method question connects the work performed to the service claimed. The validity question connects an additional chemistry charge to the drug test it supports. An insider who knows both the laboratory method and the billing instructions can explain why the claim does not describe the work honestly.

The accompanying integrity agreement required clearer requisition forms, clinical oversight and independent claims reviews. Those requirements reached back from the bill into the ordering and clinical decisions that produced it.

The Sales Promise and the Bill

In a separate qui tam case, a competing laboratory alleged that Calloway Laboratories and AIT Laboratories supplied free dual-use collection cups to induce referrals, quoting AIT’s advertising:

Free to the practice. Somebody else gets the bill.

That alleged referral arrangement puts the sales promise beside the payment request. For a specimen validity charge, we ask the corresponding question: did the laboratory sell a separate clinical service, or simply add a bill for checking the sample?

Medicare Kept Paying After the Edit

The Inspector General’s February 2018 audit identified $66.3 million in improper Medicare payments to 4,480 clinical laboratories and physician offices for specimen validity tests billed with urine drug tests.

The government’s automated safeguard still let money through. Within that audit, the Inspector General identified $1.8 million in improper payments from April through December 2016, after CMS introduced the edit intended to prevent them. The rule existed. The extra bills still got paid.

The Inspector General attributed the problem to providers failing to follow existing guidance and to inadequate payment edits.

For a laboratory employee, payment history can make an entrenched billing practice look settled. This audit shows the weakness in that reassurance. A paid chemistry line can still represent work included in the accompanying drug test. The useful explanation lies in the service and its purpose, not simply in the fact that Medicare processed the claim.

What the Specimen Check Adds to the Drug Result

Specimen integrity affects what a drug result means. A 2014 review in PharmacologyOnline describes creatinine and specific gravity as ways to detect possible dilution. It also explains how adulterants can disrupt testing and how routine checks of pH, creatinine, specific gravity and temperature can miss some adulterants.

The markers therefore answer different questions about the sample. Dilution lowers concentration. Adulteration introduces a substance that interferes with testing. Substitution supplies urine or a urine-like material from somewhere other than the patient. Counting the chemistry results does not tell you how many separately payable clinical services occurred.

Urine Drug Screening: A Guide to Monitoring Tx With Controlled Substances, published in The Journal of Family Practice in 2021, explains why the specimen’s concentration matters:

That is real analytical work. It helps interpret the drug test. It does not turn each specimen check into another payable service.

When Are Toxicology Tests Unnecessary?

Toxicology tests become unnecessary when testing follows a blanket practice or a nonmedical requirement instead of the patient’s clinical need. That same question about purpose runs through a specimen validity billing case: what patient need drove the charge?

In its Genotox settlement announcement, the Justice Department reported that the company admitted using custom profiles that preselected tests for all or nearly all of a provider’s patients, generally at the highest reimbursement categories. The form carried the testing decision from patient to patient.

LabTox’s later case shows another route. According to the owner’s criminal plea agreement, as described in the government’s civil judgment announcement, he knew that court-ordered tests for judicial proceedings were nonmedical testing and caused LabTox to bill Medicare and Kentucky Medicaid anyway. The later civil judgments resolved a qui tam case brought by a whistleblower. A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.

When You Know Why the Extra Charge Appears

If you know how your laboratory turns specimen checks into separate claims, speak with our whistleblower experts about the billing decisions behind them. We work beside you to build your strongest laboratory fraud case, connecting the clinical purpose, the work performed and the decisions that shaped the bill. We bring in laboratory fraud whistleblower lawyers who understand toxicology claims and healthcare billing, and we stay with you through the whole journey.