04/23/2025 | Press release | Distributed by Public on 04/23/2025 07:50
PHILADELPHIA - United States Attorney David Metcalf announced today that Genexe, LLC, Immerge, Inc., Jason Green, and Jason Gross have agreed to pay $6 million to resolve allegations that they violated the False Claims Act and other statutes by participating in schemes meant to fraudulently cause Medicare to pay claims for genetic testing that was medically unnecessary and tainted by kickbacks.
Genexe, LLC, which did business as Genexe Health, is a Delaware limited liability corporation with a principal address in Greenwood Village, Colorado. Genexe publicly described itself as "a one-stop shop" for genetic and pharmacogenetic profiling and marketed itself as "involved in every aspect of the patient screening process, from the collection of samples to laboratory processing." It conducted business in the Eastern District of Pennsylvania, among other locations. Genexe is no longer operating.
Immerge, Inc., also known as Immerge LLC, controlled and is the parent company of Genexe. It was incorporated in Colorado and Delaware, with a principal address in Greenwood Village, Colorado. It publicly described itself as "one of the leading outsourced sales and marketing companies, providing customized sales and marketing solutions to Fortune 500 companies and industry leaders in the Energy, Telecom, Wireless and Solar industries to efficiently increase our clients' revenue and market share through industry leading systems and processes." Immerge operated Genexe as one of its marketing companies. Immerge is no longer operating.
Jason Green and Jason Gross were, respectively, the Chief Executive Officer and Chief Operating Officer of Genexe and Immerge, with ownership interests in both Genexe and Immerge.
Genetic tests are medical laboratory tests designed to identify specific inherited mutations in a patient's genes. Genetic mutations or variations may affect a patient's risk of developing certain diseases or the patient's response to medications. Genetic tests related to a patient's hereditary predisposition for cancer are commonly referred to as "CGx" tests. Pharmacogenomic genetic tests related to identifying how a patient's genes affect a response to drugs are commonly referred to as "PGx" tests.
Genetic testing can involve obtaining a DNA sample from a patient using a genetic test kit, sometimes by obtaining a patient's saliva using a cheek (buccal) swab to collect sufficient cells to provide a genetic profile. The DNA sample may then be submitted, along with a requisition form, to a laboratory for analysis, such as a CGx or PGx test. The requisition form typically included information about the patient, the swab being submitted, and the referring physician or other medical provider. That provider or another authorized person must confirm on the form that the genetic test was medically necessary.
To be covered under Medicare Part B, a clinical laboratory test, such as a genetic test, must be ordered by a physician (or a qualified nonphysician practitioner) who is treating a beneficiary for a specific medical problem and who uses the results in the management of that problem. The test must be related to the beneficiary's illness or injury (or symptom or complaint).
Medicare does not cover the costs associated with testing that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. It is a violation of the Anti-Kickback Statute to knowingly and willfully solicit, receive, offer, or pay any remuneration in return for referring an individual for the furnishing or arranging for the furnishing of any item or service for which payment may be made, in whole or in part, under a federal health care program.
The United States' claims arise from Genexe, Immerge, Green, and Gross's alleged conduct in knowingly and improperly causing false claims to be submitted to Medicare for CGx and PGx tests that were not medically necessary and that were procured through kickbacks. Specifically, the United States contends that during the period from July 2018 through December 2019:
"Genetic testing fraud preys on the fears of patients, and it wastes taxpayer dollars by spending limited funds on medically unnecessary or nonexistent tests," said U.S. Attorney Metcalf. "This settlement shows we will work with our law enforcement partners to investigate fraud, waste, and abuse in federal healthcare programs and will use every tool available to recover improperly paid taxpayer funds."
"Medical professionals should only order testing which would benefit individual patient care, not for personal gain," said Maureen Dixon, Special Agent in Charge for the U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG). "HHS-OIG, the U.S. Attorney's Office, and our law enforcement partners will continue to evaluate and pursue allegations of kickbacks resulting in medically unnecessary services."
The settlement also resolves claims against Genexe, Immerge, Green, and Gross in lawsuits filed under the whistleblower provisions of the False Claims Act, which permits private parties, called relators, to file suit on behalf of the United States for false claims and share in a portion of the government's recovery. Those lawsuits include United States ex rel. Shimi v. Genexe, LLC, et al., No. 19-CV-3660 (E.D. Pa.), and United States ex rel. Covington v. Genexe, LLC, et al., No. 23-CV-2915 (E.D. Pa.). As part of today's resolution, four relators will collectively receive approximately $1.3 million.
The matter is being handled by Assistant United States Attorney Mark J. Sherer and Auditor Denis J. Cooke.
The claims resolved by the settlement are allegations only and there has been no determination of civil liability.
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