Tampa Toxicology Lab Allegedly Ordered Unnecessary Drug Tests to Boost Profits of Taxpayer dollars

Cover photo for illustrative purposes only. Photo by U.S. Department of Agriculture | Flickr

In an announcement from the U.S. Attorney for the Western District of Michigan, a Tampa-based medical lab, Physicians Toxicology Laboratory, LLC (PTL), has agreed to a $4,425,000 settlement agreement to resolve allegations that it violated the False Claims Act (FCA).

According to the U.S. District Attorney, Mark Totten, PTL allegedly urged physicians to order medically unnecessary urine drug and hormone testing by submitting claims for reimbursement to the Medicare Program for those tests in a scheme to artificially boost profits off the backs of hardworking Americans paying into the tax system.

“Lab tests should be ordered based on each patient’s medical needs and not just to increase laboratory profits,” said U.S. Attorney Mark Totten. “Laboratories and ordering practitioners must play by the rules. We will not tolerate conduct by Medicare-enrolled practitioners and laboratories that unnecessarily increases costs to the Medicare Program and wastes taxpayer funds.”

The United States alleged that PTL provided their laboratory services for several medical practices across the state of Michigan. These practices then ordered urine drug tests (UDTs) for their Medicare patients, and PTL ran these tests to be billed to the tax-payer funded Medicare Benefits Program for approximately three years.

The report states that the Michigan medical practices routinely ordered two types of UDTs: presumptive and definitive.

A presumptive UDT is an initial test to detect the presence or absence of a substance or class of substances in the body. A definitive UDT is a more advanced, and typically more expensive, test that can identify individual drugs, distinguish between structural isomers, and report the results of drugs present in concentrations of nanograms per milliliter.

Under its rules, Medicare requires that claims for UDTs be based on an individualized determination for each patient. Medicare does not cover “blanket” orders for UDTs.

Despite these rules, the United States alleged that from January 1, 2017, through December 31, 2019, PTL encouraged these medical practices in Michigan to order UDTs under blanket orders for all patients without an individualized determination of medical necessity. Specifically stating that PTL created — and encouraged the practices to use — requisition forms that included a simultaneous order for both presumptive and definitive UDTs.

PTL also allegedly employed and placed in-office urine collectors within these practices, and the collectors typically filled out the blanket orders before submitting them to PTL. As a result, the practices ordered medically unnecessary and non-covered UDTs from PTL, and PTL knowingly submitted these claims to Medicare for fraudulent reimbursement.

In addition to UDTs, it's alleged that PTL billed Medicare for urine tests for hormone level reports, which is normally already included in the reimbursement cost associated with a UDT Medicare claim; one Michigan medical practice was said to routinely order the hormone testing in addition to nearly every standard UDT, submitting claims for each.

The United States previously settled allegations of FCA liability for ordering these tests with two of the Michigan practices for a total of $188,633.18. These practices include Family Health Partners, P.C. (and its owner Michael J. Septer, D.O.) of Grand Rapids, and Advanced Pain Solutions, PLLC d/b/a Vitruvian Health of Ionia.

In connection with the settlement, PTL, Lund Capital Group (PTL's grandparent company), previous PTL President Matthew Ryan Lund, and Thomas C. Lund entered into a three-year Integrity Agreement (IA) with the Department of Health and Human Services Office of Inspector General (HHS-OIG).

The Integrity Agreement requires, among other things, that PTL establish and maintain a compliance program and employ a clinical director responsible for reviewing and approving policies and practices related to clinical decision-making, as well as reviewing statements made in marketing materials or by sales staff related to medical necessity or clinical decision-making.

The IA also requires PTL to engage an independent review organization to perform a review of claims to determine whether the items and services furnished were medically necessary and appropriately documented.

“Health care providers are expected to follow the rules and regulations of the Medicare program, but knowingly submitting claims for medically unnecessary services violates that trust and wastes valuable taxpayer dollars,” said Special Agent in Charge Mario M. Pinto of the United States Department of Health and Human Services Office of Inspector General (HHS-OIG). “This settlement reflects the commitment of HHS-OIG and the U.S. Attorney’s Office to protect the integrity of the Medicare program by working together to hold providers that submit false claims accountable for their actions.”

The settlement agreement reached was a result of a coordinated effort between the U.S. Attorney's Office for the Western District of Michigan and HHS-OIG. Assistant United States Attorney Andrew J. Hull, and Senior Trial Counsel, Christopher Terranova, from the Justice Department’s Civil Division Commercial Litigation Branch (Fraud Section), prosecuted this case.

While the settlement agreement is not an admission of guilt or liability by PTL, the allegations speak volumes to the public who put their faith in the medical system maintaining honesty and integrity, and may one-day rely on Medicare to assist in being able to pay for their treatments.

Article by Rachael Volpe