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February 28, 2024

The owner and operator of a clinical laboratory in Georgia has pleaded guilty and agreed to pay $14.3 million to resolve charges of paying illegal kickbacks and causing false claims to be submitted to Georgia’s Medicaid program.  According to Capstone Diagnostics’ former laboratory manager, Andrew Maloney directed Capstone to pay volume-based commissions to independent sales representatives in exchange for them arranging medically unnecessary urine drug tests and respiratory pathogen panels to come their way.  The laboratory ultimately submitted over $1 million in tainted claims to Georgia Medicaid.  For bringing a successful case under the False Claims Act, whistleblower Jesse Allen will receive almost $3 million.  DOJ

January 10, 2024

Clinical laboratory RDx Bioscience Inc. and its owner and CEO Eric Leykin have agreed to pay over $10 million to the federal government and about $3 million to the State of New Jersey for violating the Anti-Kickback Statute and federal and state False Claims Acts.  From 2018 to 2022, RDx and Leykin were allegedly involved with five types of kickback schemes in order to induce referrals to RDx for laboratory testing, then submitted or caused false claims to be submitted to Medicare and Medicaid that were unnecessary or uncovered.  DOJ

December 21, 2023

Ultragenyx Pharmaceutical, Inc., maker of Crysvita, will pay $6 million for violating the False Claims Act. Crysvita is prescribed to treat a rare inherited blood disorder, which may require a genetic test to definitively diagnose. To induce purchases and referrals, Ultragenyx paid a laboratory to conduct genetic tests at no cost to healthcare providers or patients, and then provide the results reports to Ultragenyx. Ultragenyx then used the positive test results reports to target healthcare providers for Crysvita sales. Internally, Ultragenyx referred to this kickback scheme as their "sponsored" testing program. The program was exposed via a qui tam whistleblower, who will receive $1.07 million of the $6.7 million recovery. DOJ

October 18, 2023

The president of a California-based medical technology company has been sentenced to 8 years in prison and ordered to pay $24 million in restitution in the first COVID-related criminal securities fraud case charged by DOJ and the first COVID-related criminal healthcare fraud case brought to trial.  Among many things, Mark Schena of Arrayit Corporation was found to have taken advantage of the pandemic by claiming he and his company had developed a technology to test for just about any disease, including COVID, using a single drop of blood.  In doing so, Schena and Arrayit lied to investors to give them a false sense of credibility, paid illegal kickbacks to marketers to run deceptive plans about the accuracy of its tests, and submitted false claims to Medicare and private insurers for medically unnecessary allergy testing.  DOJ

October 2, 2023

Genomic Health, Inc. (GHI), a wholly-owned subsidiary of Exact Sciences Corporation that provides clinical diagnostic tests, has agreed to pay $32.5 million to resolve two separate qui tam suits alleging violations of the False Claims Act and Anti-Kickback Statute in connection with lab tests for cancer patients.  GHI allegedly evaded Medicare’s 14-Day Rule—which prohibits labs from separately billing for the same covered tests within 14 days of a patient’s discharge from a hospital—by canceling and reordering tests so they fell within appropriate time frames, seeking reimbursement directly from Medicare, and writing off unpaid lab fees owed by hospitals.  As a result of this settlement, the whistleblowers in the case will receive over $5.5 million.  DOJ

August 18, 2023

The owner and operator of Georgia-based LabSolutions LLC has been sentenced to 27 years in prison for submitting over $463 million in medically unnecessary genetic and other laboratory tests derived from illegal kickbacks.  Minal Patel allegedly paid kickbacks to telemarketing companies to talk Medicare beneficiaries into getting the tests, then paid kickbacks to telemedicine doctors who signed orders for the tests without ever speaking to beneficiaries to determine need.  As a result of these fraudulent actions, Medicare paid over $187 million in reimbursement, with Patel receiving over $21 million personally, between 2016 and 2019.  DOJ

August 4, 2023

Aspirar Medical Lab LLC and owner Pick Chay have agreed to pay almost $2 million to resolve allegations of defrauding the North Carolina Medicaid program.  The company allegedly paid two other companies for referring medically unnecessary urine drug tests to it, then submitted claims stemming from these illegal kickbacks to Medicaid.  NC AG

August 1, 2023

A now defunct clinical laboratory in Texas, BestCare Laboratory Services LLC, and its owner, Karim Maghareh, have agreed to pay another $5.7 million on top of nearly $800,000 already paid to the government to resolve an outstanding obligation under a 2018 judgment for violating the False Claims Act.  The underlying lawsuit, filed in 2008 by whistleblower Richard Drummond, alleged that BestCare billed Medicare for travel by lab technicians that did not reflect the actual mileage traveled.  DOJ

June 8, 2023

Billy Joe Taylor of Lavaca, Arkansas, will spend 15 years in prison and will pay nearly $30 million in restitution for submitting false and fraudulent claims to Medicare. During the COVID-19 pandemic, Taylor and his co-conspirators misused medical information and private personal information for Medicare beneficiaries, and then used that information to repeatedly submit fraudulent claims for medically unnecessary diagnostic laboratory testing. USAO WDAR

April 4, 2023

From 2014 to 2022, medical testing company Genotox Laboratories Ltd. paid kickbacks to their “1099” representatives, calculated as a percentage of the revenue Genotox received from Medicare, the Railroad Retirement Board, and TRICARE billings for testing orders facilitated or arranged for by these representatives. In addition to the kickbacks, Genotox also allowed providers to create “custom profiles” to pre-select the tests to order for their patients, often resulting in medically unnecessary testing, such as definitive drug testing for 22 or more drug classes. Genotox will pay $5.9 million, and Genotox’s former billing manager—the whistleblower in this qui tam action—will receive approximately $1 million. DOJ
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