Genetic Technological Innovations, LLC (GTI), a diagnostic laboratory based in Scottsdale, Arizona, has agreed to pay $1.635 million to the United States. The payment resolves allegations that GTI violated the False Claims Act and the Anti-Kickback Statute.
According to the U.S. Attorney for the District of Maryland, Kelly O. Hayes, and Special Agent in Charge Maureen Dixon from the Department of Health and Human Services Office of Inspector General (HHS-OIG), GTI is accused of submitting claims to Medicare for respiratory pathogen panels (RPPs) that were either not medically necessary or obtained through improper kickbacks.
The government alleges that on June 5, 2020, GTI entered into a Marketing Services Agreement with an infection prevention company. Under this agreement, the marketing company was supposed to provide services in long-term care facilities and received monthly payments from GTI for each facility it serviced. However, authorities allege that these payments were actually for laboratory test referrals billed to Medicare, violating anti-kickback laws.
Additionally, it is alleged that GTI paid the company to collect specimens from residents in long-term care facilities for infectious disease testing. While swabbing residents for COVID-19 tests, GTI used those same specimens to perform RPPs and billed Medicare for them—even when such panels were not requested or needed by physicians. The reimbursement rate for RPPs was significantly higher than for COVID-19 tests alone.
Between June 2020 and January 6, 2021, GTI reportedly combined RPPs with COVID-19 tests even when only COVID-19 testing had been requested by facilities. The RPPs were conducted on nearly every resident without individualized medical assessments by their physicians.
“Kickback arrangements to induce patient referrals for the purpose of billing federal health care programs for medically unnecessary diagnostic tests is inexcusable,” Hayes said. “This settlement is a testament to our continued commitment to protecting both patients and the public fisc that fund federal health care programs.”
“This settlement underscores our agency’s steadfast commitment to investigating alleged Anti-Kickback Statute and False Claims Act violations targeting the Medicare program,” Dixon said. “Ensuring the integrity of federal health care programs is a chief objective for HHS-OIG and our law enforcement partners.”
U.S. Attorney Hayes acknowledged HHS-OIG’s role in investigating this matter and thanked Assistant U.S. Attorney Tarra DeShields as well as DOJ Civil Division attorneys Kelly McAuliffe and Asha Natarajan.
The settlement reflects ongoing efforts by federal authorities to address healthcare fraud using statutes like the False Claims Act. The Department of Health and Human Services accepts tips about potential fraud at 800-HHS-TIPS (800-447-8477).
It should be noted that these claims are allegations only; there has been no determination of liability.
Further information about the Maryland U.S. Attorney’s Office can be found at https://www.justice.gov/usao-md and https://www.justice.gov/usao-md/community-outreach.
