UTC Laboratories / RenRX: Pharmacogenetic Referrals and a 25-Year Exclusion

In the UTC Laboratories Renaissance RX settlement, UTC and three principals agreed to pay $42.6 million over alleged kickbacks for pharmacogenetic referrals and Medicare bills for unnecessary testing. The whistleblower’s complaint reaches inside the doctor’s office: it alleges cash for access to patients, daily swab quotas and medication histories changed to make patients qualify. For someone who worked on specimen collection, orders or billing, the case turns on who decided the test was needed and what the paperwork said afterward.

UTC Laboratories operated as Renaissance RX, also called RenRX, from New Orleans, Louisiana. The Department of Justice announced the settlement on October 9, 2019. The settlement resolved six qui tam cases brought by whistleblowers under the False Claims Act. The government joined them.

Do Doctors Get Kickbacks for Ordering Tests?

The government alleged that UTC paid physicians to induce pharmacogenetic test orders. Between 2013 and 2017, according to the Justice Department, UTC and its principals offered those payments purportedly in return for participation in a clinical trial called the Diagnosing Adverse Drug Reactions Registry, known as DART, clinical trial identifier NCT01970709. The government also alleged payments to other entities and individuals, including sales commissions, and Medicare billing for tests that were not medically necessary.

The whistleblower’s complaint described what the physician payments allegedly bought. It said doctors received cash for every patient tested even though neither the doctor nor the office staff performed testing-related work. The complaint put the alleged exchange plainly:

Access to a practice’s patients was the valuable service in that account. The doctor’s office supplied a place to find people for testing, while the payment gave the physician a reason to make them available. The government’s medical-necessity allegation concerns the next decision: why each patient needed the test that Medicare would be asked to pay for.

Medication Histories Changed to Qualify Patients

The complaint alleged that medical assistants and collectors were directed to falsify patient records to make DNA testing appear medically necessary. It described instructions to disregard medication-testing guidelines and supplied a concrete example:

For a test concerned with how a person processes medication, the medication history is central to the story. The alleged alteration put drugs into the patient’s screening record that were absent from the patient’s actual treatment. The paperwork then supplied a reason to test that the patient had not supplied.

That is a specific kind of knowledge an insider can bring. Someone who saw the original medication list and the later screening form can explain the change. Someone who heard the instruction can explain why it happened. Our work is to connect those accounts to the test ordered, the laboratory’s claim and the people directing the process.

A Daily Swab Target and a Bill for Each Test

The complaint alleged that medical assistants had a minimum quota of eight swabs a day and were expected to exceed it. The clinical question is different: which patient needs which test, and why?

The whistleblower also alleged that Medicare was billed $2,000 per DNA test. Put beside a daily collection target, it explains why the decision to qualify a patient mattered financially as well as medically.

The pressure described in the complaint reached the screening process itself. Staff were allegedly expected to produce swabs and told to alter the information used to qualify patients. Those allegations connect the volume target to the claimed reason for testing. A collection count, the instructions given to collectors and the patient screening records tell different parts of that same story.

Who Discussed the Test With the Patient?

An internal email quoted in the complaint described collectors discussing testing and research with patients, then set out a changed process that put a provider’s conversation first. Its wording gives an insider something more concrete than a general allegation about unnecessary tests:

The company’s own email puts collectors in the patient conversation before the proposed change. Alongside the allegation that doctors did not prescreen or approve patients, it points to who was driving the decision to test.

The Clinical Decision Behind the Laboratory Claim

An independent laboratory’s claim depends on a clinical decision made in the treating practice. The physician or qualified practitioner orders the test and keeps the medical-necessity documentation in the patient’s record. The laboratory performs the work and bills, retaining what it receives from the ordering practitioner and documentation that its claim accurately reflects that information.

This separation helps explain why the medication-history allegation matters. The specimen arriving at the laboratory cannot explain who added a drug to a screening form or whether the patient took it. That part of the story sits upstream, in the office where the patient was recruited and screened. Connecting the office records to the laboratory records puts the claimed medical reason beside the service billed.

The 1997 Laboratory Medicine article Model Plan Helps Laboratories Fight Fraud described the inspector general’s recommendation for requisition forms that give physicians space to document the medical necessity of each test. It also described explaining the components of laboratory profiles and their billing to ordering physicians. The design of the order form and the doctor’s understanding of what it orders are part of the payment story.

In the RenRX complaint, the alleged intervention came even earlier, when staff changed medication histories used to qualify patients. The useful comparison is between what the treating practice knew about the patient and what the testing operation recorded as its reason to proceed.

The Sales Side of a Laboratory Order

UTC’s sales compensation also followed the money collected from testing. In findings issued in January 2024, a federal court in a separate insurance dispute described UTC’s business as marketing and soliciting laboratory referrals, then billing and collecting from third-party payers.

The court found that the area vice presidents’ monthly commissions and quarterly bonuses were based on sales collections and revenue collected in their geographic areas. It described a business that included pharmacogenomics and toxicology testing.

The Justice Department’s civil allegations separately identified sales commissions among the payments in the referral scheme. We examine what a compensation arrangement paid for and connect it to the orders and claims it concerned.

When a Study Payment Buys a Referral

A study payment can give a referral payment a different description on paper. The RenRX settlement concerned alleged physician inducements presented as participation in DART.

In the separate Primex Clinical Laboratories and DNA Stat case, the government alleged that payments presented as compensation for clinical study data bought patient referrals.

The inspector general’s June 2014 alert also addressed laboratory registry arrangements.

That context gives the DART allegation its industry significance. Research participation was the stated reason for paying physicians. Test ordering was the behavior the government alleged the payments induced. The work performed, the information collected and the basis for payment are where those accounts can be compared.

What the RenRX Settlement Required

RenRX agreed to pay $41.6 million. Its three principals agreed to pay $1 million combined. The company also agreed to a 25-year exclusion from participation in any federal health care program.

The alleged healthcare scheme put patients through unnecessary tests and sent the bill to Medicare and taxpayers. The story runs from access to patients through the screening record, the test order and the Medicare bill. It also runs back toward the referral source through the payments the government alleged were kickbacks. People working at those different points can see conduct that a completed claim alone does not explain.

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

You Saw How the Patients Became Orders

If you know who changed the medication histories, bought access to a practice or tied payments to its testing, speak to one of our Whistleblower Experts about the laboratory arrangement you saw. We develop the case with you and bring in laboratory fraud whistleblower lawyers who understand referral payments and medical-necessity evidence. We stay beside you through the process, using your knowledge of the business to build your strongest laboratory fraud whistleblower case.