Gonzaga Interventional Pain Management: The Urine Sample Came Before the Provider Visit

In the Gonzaga urine drug testing settlement, Gonzaga Interventional Pain Management, its physician owner and its chief executive officer agreed to pay $980,000 over allegations of billing for medically unnecessary tests. The government alleged that the Maryland practice used blanket orders instead of deciding what each patient needed, then often ignored unexpected results while continuing to prescribe controlled substances.

The practice operated a pain-management clinic in LaVale, Maryland. Its owner was a board-certified anesthesiologist and pain management specialist. His son served as chief executive officer. The U.S. Attorney’s Office for the District of Maryland announced the civil False Claims Act settlement on August 5, 2022.

Blanket Orders Before the Provider Visit

The government alleged that Gonzaga Interventional Pain Management tested all patients for the same 22+ drug classes under blanket orders. Patients had to provide a urine sample when they entered the clinic, before seeing a provider and discussing the results of any previous urine drug test.

The patient arrived, supplied a sample and entered a testing process whose menu was already set. The government said the tests billed to it lacked an individualized determination of medical necessity.

From January 1, 2016 through March 31, 2019, the practice billed Medicare, Medicaid and the Railroad Retirement Board for a large number of urine drug tests.

Presumptive and Definitive Tests Under Blanket Orders

Gonzaga Interventional Pain Management used both presumptive and definitive urine drug tests under what the government alleged were blanket orders.

Urine drug testing has a clinical purpose in pain management. The 2014 Pain Physician paper Ethical Perspectives on Urine Drug Screening for Pain Physicians describes its use in checking adherence to prescribed medication and detecting nonprescribed or illicit drug use. It also explains how quantitative toxicology can provide information about drug interactions, absorption and metabolism.

The paper stresses that results need clinical context. Test methods have limitations, and an unexpected result requires interpretation.

When Are Toxicology Tests Unnecessary?

In Gonzaga’s case, the government alleged that the toxicology tests were unnecessary because blanket orders replaced a decision about each patient’s needs.

The Medicare diagnostic-testing rule connects the order to the treating clinician, who uses the results to manage the patient’s specific medical problem. The ordering clinician must keep the medical-necessity documentation in the patient’s record. With a standing selection for everyone, where is the decision about this patient’s need?

The HHS Office of Inspector General’s laboratory compliance guidance says a standing order alone usually does not show that a patient needed the test.

Results That Went Unused

The government also alleged that Gonzaga’s providers often ignored unexpected positive or negative results, or did not check them at all, while continuing to prescribe opioids and other controlled substances despite obvious warning signs of drug abuse. Taxpayers were billed for tests that, in the government’s account, often made no difference to prescribing.

The 2021 Journal of Family Practice article Urine Drug Screening: A Guide to Monitoring Tx With Controlled Substances recommends risk-based testing and a response to unexpected findings grounded in the patient’s history or further testing.

The clinical literature describes information gathered to help manage care. The government’s account of Gonzaga describes a routine that collected specimens before the provider visit and often left important findings unused afterward. A more detailed laboratory result has little value to that encounter if nobody checks it.

Who Chose the Tests on the Order Form?

The order form can determine whether test selection happens patient by patient or once for a whole practice. The Inspector General’s laboratory guidance says requisitions should preserve an independent medical-necessity decision for each test the laboratory will bill. A form’s defaults and preselected options therefore deserve attention alongside the completed orders.

In a parallel case, Genotox Laboratories admitted offering custom profiles through which providers preselected tests that the laboratory then performed and billed for all or nearly all of their patients.

In the Precision Toxicology settlement, the government likewise alleged that custom profiles operated as standing orders for excessive testing without individual assessments. Gonzaga’s alleged workflow placed the same missing decision inside the pain-management practice.

The Clinical Record and the Billing Record

Who set Gonzaga’s 22+ drug-class menu? When was the sample collected? Did anyone review the result? Those are the connections our whistleblower experts examine with you.

How the Gonzaga Case Began

The Gonzaga case arose from the Maryland U.S. Attorney’s Office’s review of Medicare billing data. The HHS Office of Inspector General and the Railroad Retirement Board’s inspector general participated in the investigation.

An insider can explain the decisions behind the testing: why the menu stayed the same, when the sample was collected and what happened to the result.

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

You Know How the Testing Was Chosen

If you worked with blanket orders, patient results or the claims they produced, speak to one of our Whistleblower Experts about how the testing was chosen. We build your strongest laboratory fraud whistleblower case with you, bring in healthcare fraud whistleblower lawyers who understand medical-necessity disputes, and remain your partners as the case moves forward.