Ellis Pain Center: Unperformed and Unnecessary Drug-Test Claims

Ellis Pain Center and its physician owner agreed to a $5 million civil settlement over allegations that they billed Medicare for unperformed and medically unnecessary urine drug tests and other unnecessary diagnostic tests. The government’s most concrete allegation concerned the equipment: the practice billed for expensive quantitative tests that, the government said, its immunoassay analyzer could not perform. Someone who knows the machine’s work and the claims leaving the billing office can recognize the gap.

The Athens-area pain management practice settled on March 17, 2023. Its practice manager also joined part of the settlement. The case also named Ellis Practice Management.

What the Ellis Pain Center Case Alleged

The Justice Department alleged separate failures in test performance and medical necessity. On performance, it said Ellis Pain Center billed Medicare for individual quantitative urine drug tests that the practice did not conduct and could not have conducted on its immunoassay analyzer. That is a specific mismatch between the work claimed and the equipment available to do it.

On necessity, the government alleged that the practice, its physician owner and its practice manager billed for the same urine drug tests without regard to patients’ individual signs, symptoms and medical needs. The government attributed that testing to a desire to increase the practice’s revenue.

The government also alleged unnecessary diagnostic testing beyond urine tests. It said the practice billed for those tests without regard to what its pain patients needed.

Money intended to support patients’ care went toward services the government said either had not happened or had no medical justification for those patients.

Unperformed Drug Tests and the Analyzer Behind the Bill

Ellis Pain Center’s alleged unperformed drug tests exposed a gap between the equipment in the practice and the services on the bill. The clinical distinction between an office screen and confirmatory testing explains why the analyzer matters.

The Journal of Family Practice’s 2021 clinical review, Urine Drug Screening: A Guide to Monitoring Tx With Controlled Substances, describes immunoassay as a rapid, relatively inexpensive method suited to office testing. It produces presumptive screening results. The review contrasts that method with chromatography combined with mass spectrometry, which separates a specimen’s components and identifies them, producing more specific confirmatory results.

Those differences carry through the workflow. The review describes confirmatory testing as more expensive and slower, particularly when specimens go to an outside laboratory. A bill for that work describes a different service from an office screen. In the Ellis Pain Center allegations, the disputed jump was from the practice’s immunoassay analyzer to individual, expensive quantitative tests on Medicare claims.

For an insider, that makes the analyzer and its output central to the story. We examine what the equipment could do, what testing it recorded and what the practice claimed. Calling everything a urine drug test can conceal the very difference the government challenged.

When Are Toxicology Tests Unnecessary?

Toxicology tests are unnecessary when the testing lacks a patient-specific medical reason. In the Ellis Pain Center case, the government alleged that tests were billed without regard to individual signs, symptoms and medical needs. The clinical question is why that patient needed that test, and what its result would contribute to care.

Urine testing has a defined role in pain treatment. The 2014 Pain Physician paper Ethical Perspectives on Urine Drug Screening for Pain Physicians describes its use to detect illicit drug use and monitor adherence to prescribed medication.

The Journal of Family Practice review recommends risk-based testing frequency for patients receiving chronic opioid therapy. Its discussion of addiction treatment makes the frequency problem plain:

The Pain Physician paper also stresses that test results need clinical context. It says they should not dictate treatment decisions in isolation.

In the Ellis Pain Center case, the government alleged that the same tests went onto bills without regard to patients’ individual needs.

What Evidence Is Needed to Prove Fraud?

Our whistleblower experts work out with each insider what evidence can connect the testing they know to the Medicare claims. A billing employee may see the service charged. The person working with the analyzer may know whether that service matches what was done.

Under Medicare’s diagnostic-testing rules, the clinician keeps the reason for testing in the patient’s chart, while the biller keeps the order information and records supporting the claim’s accuracy. The medical reason and the bill can sit in different parts of the workflow.

For health care staff with an unperformed-test concern, we examine the relationship between the billed service and the laboratory’s actual work. For unnecessary testing, we examine how the order, clinical record and use of results fit together. In a case involving a physician owner and practice administration, the decisions that connect those records matter as much as the records themselves.

The strongest account can explain the discrepancy in the language of the workplace: which test the order called for, which test the equipment performed and which service the bill described. Our whistleblower experts work with insiders to connect that knowledge to the Medicare claims and the decisions behind them.

The Toxicology Pattern Beyond Ellis Pain Center

Unnecessary urine drug testing also drove the allegations behind the civil settlement involving Logan Laboratories, Tampa Pain Relief Centers and two former executives. The April 2020 resolution reached both the laboratory and the referring practice. A whistleblower’s complaint in that matter described how decisions inside a practice could increase testing before a specimen ever reached the laboratory.

The complaint alleged that Surgery Partners, a defendant in one of the whistleblower suits resolved by that settlement, changed electronic patient-risk classifications to justify more frequent urine drug testing:

A risk assessment is supposed to inform testing frequency. The allegation describes changing that assessment to produce more testing. It gives an insider a concrete example of how a clinical justification can become a revenue decision inside the practice’s software.

Ellis Pain Center’s alleged mechanism was specific to its own practice: bills for quantitative tests its analyzer could not perform, alongside testing without regard to individual medical needs. The parallel shows why an inquiry into unnecessary testing can reach the administrative choices behind an order, as well as the laboratory that receives it.

The Civil Settlement and Whistleblower Cases

The Justice Department announced the Ellis Pain Center settlement on March 20, 2023, resolving the Medicare billing allegations under the False Claims Act.

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers. For someone inside a pain practice, the starting point for a conversation with us is the connection they can explain between the test, the patient record and the claim.

You Know the Test Behind the Bill

If the analyzer’s work and the Medicare bill tell different stories, or practice instructions drive testing without regard to patients’ needs, talk with our whistleblower experts. We build the case with you, bring in laboratory fraud whistleblower lawyers who understand pain-practice testing and Medicare billing, and stay beside you through the pursuit of a recovery.