U.S. Attorney for the Western District of Michigan Mark Totten has announced that Physicians Toxicology Laboratory, LLC of Tampa, Florida, has agreed to pay $4,425,000 to resolve allegations that it violated the False Claims Act by causing physicians to order medically unnecessary urine drug testing and hormone testing and by submitting claims for reimbursement to the Medicare Program for those tests.
Lund Capital Group, LLC (PTL’s grandparent company), PTL’s former president Matthew Ryan Lund, and Thomas C. Lund joined the settlement as jointly and severally liable co-defendants.
“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.”
WATCH: Totten video concerning the settlement.
The United States alleges that PTL provided laboratory services for several medical practices in Michigan. These practices ordered urine drug tests for their Medicare patients, and PTL ran these tests and billed Medicare. These 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 test that can identify individual drugs, distinguish between structural isomers, and report the results of drugs present in concentrations of nanograms per millilitre.
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 alleges that from January 1, 2017, through December 31, 2019, PTL encouraged these medical practices in Michigan to order UDTs pursuant to blanket orders for all patients without an individualized determination of medical necessity.
Specifically, PTL created—and encouraged the practices to use—requisition forms that included a simultaneous order for presumptive and definitive UDTs. PTL also employed and placed in-office urine collectors in the 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.
Additionally, the United States alleges that PTL billed Medicare for urine tests for hormone levels ordered by one of the practices with almost every UDT when the laboratory knew that the practice was ordering these tests as a form of specimen validity testing, which is already included in the reimbursed costs of UDTs.
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, Matthew Ryan Lund, and Thomas C. Lund entered into a three-year Integrity Agreement with the Department of Health and Human Services Office of Inspector General.
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 and 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.