GenomeDx Decipher: A Doctor’s Signature Before the Patient’s Name

In the GenomeDx Decipher settlement, GenomeDx Biosciences agreed to pay $1,990,380 to resolve allegations that it billed Medicare for post-operative prostate cancer genetic tests on patients who lacked the risk factors supporting them. Two employees brought the whistleblower case. Their complaint describes how a laboratory could produce a certificate of medical necessity with a doctor’s signature already on it, then add the patient’s name afterward.

The Justice Department announced the settlement on February 11, 2019. It identified GenomeDx as a genetic testing laboratory headquartered in Vancouver, British Columbia, with operations in San Diego. The government’s allegation covered claims submitted between September 2015 and June 2017.

The employees’ account went further into the business: who completed the paperwork, which test the claim described, how the laboratory obtained tissue, and what patients were billed.

Why Medicare Risk Factors Mattered to Decipher Coverage

The government alleged that GenomeDx knowingly billed Medicare for Decipher tests that were not medically reasonable and necessary because the patients lacked risk factors necessitating the test. Its announcement identified these risk factors:

• Pathological stage T2 disease with a positive surgical margin.
• Pathological stage T3 disease.
• Rising PSA levels after an initial PSA nadir, the initial low point.

That is why the medical-necessity certificate matters in this story. Under Medicare’s documentation rules for diagnostic tests, the ordering clinician maintains the medical-necessity record, while the billing entity must retain what it received and show that the claim accurately reflects it. In the employees’ account, GenomeDx was filling in the very document meant to convey the physician’s judgment about a particular patient.

The Pre-Signed Forms the Employees Described

The whistleblowers alleged that GenomeDx instructed physicians to sign blank certificates of medical necessity, then used those forms to support claims without the physician signing off on the particular test. The complaint describes what staff allegedly added:

The complaint also quotes a director’s instruction to staff about a pre-signed form:

In the employees’ telling, the signature came first. The patient and the signature date came later. In the complaint’s account, the director celebrated a form that could make a blank signature look like approval for a particular test. The employees alleged that taxpayers were being asked to fund testing on the strength of that paperwork.

A 1997 article in Laboratory Medicine described a recommendation from the HHS Office of Inspector General for uniform requisition forms with spaces for the physician to document each test’s medical necessity with a diagnosis code. The form was meant to carry the physician’s reason for ordering.

Decipher Biopsy Claims Described as Post-Op

The complaint alleged that GenomeDx supported Decipher Biopsy claims, including appeals of denied claims, with documentation identifying the tests as Decipher Post-Op. That allegation concerns what the insurer was told it was paying for.

A denied claim gave the laboratory another occasion to describe the test to the insurer. For an appeals employee, the question raised by this allegation is concrete: did the supporting paperwork describe the test the laboratory actually ran?

The employees also alleged that insurers had requested more than $1 million in repayment for fraudulent Decipher Biopsy claims.

Stored Tissue and Money Sent to a Clinic

The complaint alleged that GenomeDx obtained a tissue sample directly from a pathology laboratory and performed a test without a physician’s order or patient consent on at least one occasion. The pathology laboratory already held the patient’s tissue.

The whistleblowers also alleged that GenomeDx had arrangements under which pathology laboratories supplied stored tissue samples in exchange for payment.

They separately alleged that they saw a $10,000 check sent to a urology clinic whose physicians had ordered GenomeDx tests. Those allegations describe transactions an insider could encounter directly: a request for tissue, an arrangement with its custodian, or a payment to the practice ordering tests.

Patients Billed Despite a Waiver, the Employees Say

The whistleblowers alleged that patients complained about invoices for tests they had not consented to. They also described a particular contradiction in the Medicare Advantage appeals process:

On that account, the promise made during the appeal and the invoice sent to the patient told different stories. The waiver said the laboratory would give up collecting from the beneficiary. The later bill sought payment anyway.

An employee handling patient complaints or appeals could see this contradiction without working on the assay.

The Money Behind Molecular Test Billing

Medicare spent far more on Decipher Prostate in a single later year than GenomeDx agreed to pay in this settlement. In its analysis of laboratory spending for 2024, the HHS Office of Inspector General listed code 81542 at $94.9 million across 25,068 tests. Its table describes Decipher Prostate as a prostate cancer mRNA test involving 22 genes.

Employees Brought the Decipher Whistleblower Case

The GenomeDx case began with employees who brought a qui tam lawsuit under the False Claims Act and worked with investigators. The Justice Department announced that the two whistleblowers would receive a share of the recovery.

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.

You Know How the Form Was Completed

If you handled necessity certificates, Biopsy appeals or patient bills that contradicted a waiver, speak with our whistleblower experts about the billing decisions you saw. We build the case around your knowledge of the laboratory and bring in healthcare laboratory whistleblower lawyers who understand molecular testing claims. We stay with you as your account becomes a case for recovering public money.