Millennium Health: Custom Profiles, Free Cups and Routine Genetic Testing

In the Millennium Health fraud settlement, the company agreed to pay about $256 million to resolve allegations of unnecessary urine drug and genetic testing and free test cups tied to referrals. The government alleged that tests sold as custom profiles became standing orders, while free cups came with a condition that sent specimens back to the laboratory. A patient supplied the urine. The alleged arrangement supplied the demand for testing.

Millennium Health, formerly Millennium Laboratories, operated nationwide from San Diego. The Department of Justice announced the resolution on October 19, 2015, covering claims billed to Medicare, Medicaid and other federal health care programs. Millennium also entered a corporate integrity agreement with the Department of Health and Human Services’ Office of Inspector General.

The urine drug testing allegations covered January 1, 2008, through May 20, 2015. The government said Millennium encouraged physicians to order large numbers of tests without assessing each patient’s needs. The separate genetic-testing allegations concerned the same missing decision: why this particular patient needed this particular test.

How the Order Became a Claim

Under Medicare’s ordering and documentation rules, the treating practitioner keeps the medical-necessity documentation in the patient’s record. The billing laboratory keeps the information it receives and documentation that its claim accurately reflects it. A completed requisition can tell the laboratory which tests to run while the patient chart explains why they were wanted.

Urine drug testing has a clinical purpose that makes the alleged substitution important. The 2014 Pain Physician paper Ethical Perspectives on Urine Drug Screening for Pain Physicians describes its use in monitoring prescribed medication and detecting nonprescribed drugs. It distinguishes an immunoassay screen from confirmatory chromatography, which can address a false negative caused by the screening method. A negative screen can also reflect infrequent dosing. The result needs the patient’s clinical context.

That clinical context is what the government’s account of Millennium said was missing when broad testing became routine. For someone inside a laboratory, the important connection runs from the sales pitch and selected profile to the tests performed and the claims submitted. The order design is part of the billing story.

Custom Profiles That Replaced Patient Decisions

Millennium’s custom profiles allegedly worked as standing orders that generated broad test menus without an individualized assessment. The Department of Justice said the company promoted those profiles to physicians and then billed federal programs for excessive and unnecessary urine drug testing. The word custom promised a choice tailored to a patient. The government described a repeat order that skipped that choice.

Laboratory compliance literature had been addressing this problem long before the settlement. Model Plan Helps Laboratories Fight Fraud, published in Laboratory Medicine in 1997, described the inspector general’s recommendations for requisitions with room to document the medical necessity of each test. It also described physician acknowledgments for customized profiles and monitoring to ensure that standing orders remained valid.

The inspector general’s 1998 laboratory compliance guidance called for periodic monitoring, a fixed term of validity and renewal of standing orders. Those are controls over the decision that keeps generating tests. They reach back to the order, before a specimen becomes a result and a result becomes a bill.

In Millennium’s case, the alleged failure was patient-specific: the profile generated a large number of tests without an assessment of the person whose specimen was being tested. The useful comparison is between the menu the practice selected and the clinical reasons for running those tests on each patient. That is where someone familiar with the requisitions, account setup or testing workflow may understand something a payment total cannot show.

Why Did Free Cups Matter?

Free cups mattered because Millennium allegedly conditioned them on physicians returning urine specimens for hundreds of dollars’ worth of additional laboratory testing. The benefit went to the referring practice. The additional testing business went to Millennium. The federal government alleged that this arrangement violated the Stark Law and the Anti-Kickback Statute.

The cup itself helps explain why a supply could be valuable. In a separate case against Calloway Laboratories, a whistleblower’s complaint described dual-use cups that provided an immediate test result as well as holding the specimen:

In the Millennium settlement, the government’s allegation was the condition attached to the free point-of-care cups: the physician had to send the urine back for additional testing. The supply and the referral were parts of the same offer.

Washington’s attorney general described the arrangement in chronic pain practices, alleging that physicians ordered overly broad urine tests instead of tailoring them to each patient’s needs. A practice got the free item, a laboratory got the specimen, and government healthcare programs got the claims. The alleged cost sat with taxpayers, while the benefit was offered to the person directing the testing.

Routine Genetic Testing Without an Individual Assessment

Millennium Health’s genetic testing allegations covered January 1, 2012, through May 20, 2015. The government alleged that the company billed federal healthcare programs for genetic testing performed routinely without assessing individual need.

The Washington announcement gives the allegation a concrete clinical setting. It describes genetic testing for pain-management patients with poor or no response to traditional pain medication, then alleges that Millennium encouraged providers to order it routinely for all patients regardless of their condition. The alleged sales approach made the patient’s response to treatment irrelevant to the decision to order.

Pain patients allegedly received genetic testing because they were patients, not because anyone had assessed whether they needed it. As with the urine tests, the government’s allegation was that a routine order had taken the place of a patient-specific decision.

What the Settlement Covered

The federal announcement reported $227 million for the urine drug testing False Claims Act allegations, $10 million for the genetic-testing allegations and $19.2 million to the Centers for Medicare and Medicaid Services to resolve administrative actions related to urine drug test billing.

The corporate integrity agreement also reached the company’s leadership. The inspector general said most of Millennium’s board would consist of new independent members, with compliance monitored under a five-year agreement.

Who Brought the Millennium Cases?

Whistleblowers brought the False Claims Act cases, and the government joined parts of several qui tam cases involving urine drug testing.

One case included Allstate Insurance Company and a physician as relators. Allstate’s interest in urine drug testing arose through personal injury protection claims. The insurer’s presence shows how knowledge of a laboratory’s billing can come from outside its own payroll. A payer can see the testing that reaches its claims system, while a laboratory or practice employee may know how those tests became orders.

The announced Millennium Health whistleblower reward was $30.35 million from the urine drug testing recovery, with a separate $1.48 million award from the genetic-testing recovery.

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

The Same Order-Form Problem in Later Cases

Genotox Laboratories later admitted using custom profiles to preselect tests across patients, while the government alleged that Precision Toxicology used such profiles as standing orders without individual assessments.

You Know How the Tests Became Orders

If you worked with standing profiles, free-cup offers or routine genetic-testing orders, tell our whistleblower experts how the testing business was sold. We connect your knowledge of the practice and the laboratory to the claims, bring in laboratory fraud whistleblower lawyers who understand test selection and referral arrangements, and stand with you through the case.