NeoGenomics Laboratories Inc. (NeoGenomics), located in Florida, has agreed to pay $9,813,260 to resolve allegations that it violated the False Claims Act by providing below fair market value consulting services to certain health care providers that referred beneficiaries to NeoGenomics for laboratory testing services and by paying variable referral-based compensation to independent consultants to identify health care providers that could refer patients to NeoGenomics. In connection with the settlement, the United States acknowledged that NeoGenomics took significant steps entitling it to credit for cooperating with the government’s investigation.
“Federal law prohibits paying remuneration to induce referrals of federal health care services, including by offering services at below fair market value,” said Assistant Attorney General Brett A. Shumate of the Justice Department’s Civil Division. “We encourage companies to self-disclose improper remuneration and cooperate with our investigations in order to mitigate the consequences of prior conduct.”
“Providing services below fair market value to drive referrals – as alleged here – undermines independent medical judgment,” said Acting Deputy Inspector General for Investigations Miranda L. Bennett of HHS‑OIG. “The Self‑Disclosure Protocol remains an important tool for bringing potential violations to light and ensuring they are addressed appropriately.”
The United States alleged that, as part of NeoGenomics’ Laboratory Clinical Initiative (LCI) program, NeoGenomics provided laboratory consulting services to 28 health care providers seeking to establish in-house flow cytometry and Fluorescence In-Situ Hybridization (FISH) laboratory diagnostic capabilities. The United States contended that NeoGenomics provided certain services for less than fair market value to induce the referral of clinical laboratory tests to NeoGenomics in violation of the Anti-Kickback Statute (AKS) and that the financial relationship and resulting submission of claims violated the Stark Law. The United States further alleged that NeoGenomics entered into agreements with independent consultants that involved payments to those consultants in exchange for identifying potential health care provider customers for NeoGenomics’ laboratory services. The United States contends that the payments to the independent consultants to identify potential customers varied in part on the volume or value of referrals to NeoGenomics from those customers.
NeoGenomics self-disclosed this conduct to the United States. In addition, NeoGenomics cooperated with the government’s investigation and took remedial measures, including ending the consulting agreements at issue, terminating responsible employees, and providing the United States with a thorough self-disclosure and other supplemental information to assist the United States in its investigation.
The resolution obtained in this matter was the result of a coordinated effort between the Justice Department’s Civil Division, Commercial Litigation Branch, Fraud Section, and the Department of Health and Human Services’ Office of Inspector General.
The investigation and resolution of this matter illustrates the government’s emphasis on combating healthcare fraud. One of the most powerful tools in this effort is the False Claims Act. Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement, can be reported to the Department of Health and Human Services at 800-HHS-TIPS (800-447-8477).
This year the Administration launched the Task Force to Eliminate Fraud and the National Fraud Enforcement Division to enhance the Administration’s war on fraud, waste, and abuse in federal programs. When unscrupulous actors exploit these programs for their own financial gain, they defraud the government, harm the people these programs are designed to aid and protect, and undermine American businesses that play by the rules. The Civil Division’s FCA enforcement plays a critical role in combatting such fraudulent schemes, recovering billions of dollars for the American taxpayers, and holding wrongdoers accountable. FCA matters will continue to be on the forefront of the battle against fraud, and the Civil Division’s FCA work will support and advance the mission of the Task Force to Eliminate Fraud and the National Fraud Enforcement Division.
The matter was handled by Senior Trial Counsel Sarah Arni of the Justice Department’s Civil Division.
The claims resolved by the settlement are allegations only and there has been no determination of liability.