Access DX will pay $36.4M over alleged genetic-testing kickbacks and unbundled billing codes

On July 30, 2026, the Justice Department announced that Access DX Laboratory of Houston, Texas, its former CEO Michael Stewart, and Florida businessman Harold Shatz agreed to pay a combined $36.4 million to resolve False Claims Act allegations that they paid kickbacks and billed Medicare and Medicaid for medically unnecessary genetic testing. Two of the patterns the government described are things a coder or biller can check for on their own claims: how a genetic-testing panel is coded, and who actually ordered the test.

What the government alleged

The United States alleged that from January 2018 through January 2020, Access DX, Stewart, and Shatz paid kickbacks to marketers in return for referrals of patients for genetic testing, unbundled billing codes for genetic testing, paid telemedicine providers for false and fraudulent doctors' orders, and submitted and caused the submission of false claims for genetic testing. Those are the government's allegations. Except to the extent the two individuals admitted conduct in their plea agreements, DOJ states the claims resolved by the settlement are allegations only and there has been no determination of liability.

What Stewart and Shatz admitted

Keep the civil allegations and the criminal pleas apart, because their legal status is different. On June 24, Stewart agreed to plead guilty to conspiracy to defraud the United States and to pay and receive health care kickbacks in violation of 18 U.S.C. § 371. On October 15, 2025, Shatz agreed to plead guilty to the same offense. Both men entered civil False Claims Act settlements at the time of their pleas. The company, Access DX Laboratory, resolved the civil claims and entered a compliance agreement; it did not plead guilty.

Unbundling genetic testing codes

Unbundling is billing separately for services a single, more comprehensive code already covers. Molecular and genetic testing is a frequent target because a genomic sequencing procedure or panel code is meant to describe the whole assay, and reporting the individual gene or component lines on top of it inflates the claim. The National Correct Coding Initiative edits and your payer's molecular-pathology policy are the tools that catch it. The government alleged Access DX unbundled billing codes for genetic testing; it did not publish the specific codes, so the lesson is the pattern, not a code list.

This is the same shape as the Labcorp urine drug testing settlement, where the concern was a preselected panel that always billed the presumptive and top-tier definitive codes together, and the Magnolia Diagnostics respiratory-panel settlement, where COVID tests carried add-on panels the government alleged were unneeded. Different code families, same question: is each line on the claim its own medically necessary service, or a component the panel code already pays for.

Telehealth orders are not automatic medical necessity

A lab test billed to Medicare needs an order from a treating provider and a patient-specific reason it was run. The government alleged Access DX paid telemedicine providers for false and fraudulent doctors' orders. An order produced by a paid telehealth provider who had no real treating relationship with the patient, and whose result was never used in the patient's care, does not meet that bar, and the claim built on it is exposed. When the order trail starts at a marketer rather than a clinician, that is the documentation gap a valid, clinician-driven order is supposed to close, and the NPI lookup covers the entity side when you are reconstructing who actually ordered a test.

The kickback thread

Under the Anti-Kickback Statute, a claim that results from a prohibited referral payment is a false claim, whether or not the test was performed correctly. That is the thread connecting the pieces the government described: marketers paid for referrals, telehealth providers paid for orders, and the testing volume that followed. In connection with its settlement, Access DX entered a five-year Corporate Integrity Agreement with the HHS Office of Inspector General that requires a compliance program, training and education, and a review of its arrangements with referral sources.

How the case surfaced

The settlement resolves a lawsuit filed under the False Claims Act's qui tam whistleblower provisions by Douglas Green, the president of a Massachusetts marketing company that had been hired to market genetic testing to Medicare and Medicaid beneficiaries. Under those provisions, a private party can sue on the government's behalf and share in the recovery. Green will receive a $7.2 million share of the settlement.

Where this lands on a coder's desk

This is a Medicare and Medicaid lab-billing matter, not a risk-adjustment case, so nothing here touches your HCC mappings or RAF weights. It lands on anyone who codes or bills molecular and genetic testing, and on whoever owns the standing order sets and the outside-marketing arrangements. The self-audit is small: confirm each genetic panel is billed under the one code that describes it, and confirm each order came from a treating provider with a patient-specific reason. When the record only shows a referral, a compliant provider query before the claim goes out beats an appeal after it.