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HDL, Inc. Reaches Settlement Agreement With DOJ

Tuesday, April 14, 2015  
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“HDL, Inc. is pleased to announce that it has reached a settlement with the U.S. Department of Justice (DOJ) in conjunction with the government’s industry-wide investigation of the diagnostic laboratory industry. The agreement, which was announced earlier today by DOJ, resolves all allegations made against our company.

“In its news release, DOJ made reference to allegations that processing and handling fees were improper and that some testing was unnecessary. The payment of processing and handling fees was a longstanding practice in the diagnostic laboratory industry. In June 2014, when the government for the first time issued new guidance stating that the payments presented risk, HDL, Inc. immediately stopped paying processing and handling fees to referring providers. HDL, Inc.’s comprehensive biomarkers provide a far broader and deeper picture of patient health than the traditional reactive model based on technology available decades ago, and aid physicians in identifying risks, setting appropriate therapeutic targets and delivering the right treatments at the earliest meaningful time. Each physician chooses the testing he or she would like to perform in the best interest of his or her patients, and HDL, Inc. is proud to continue to partner with physicians to offer this critically important testing service.

“We have taken the step of resolving this matter in order to put these allegations, which stemmed from historical practices once common in the industry, behind us. These allegations were made against a number of companies operating in the clinical laboratory industry by individuals who stand to personally profit by making these allegations.

“Reaching this agreement enables HDL, Inc. to avoid the distraction of what could have been years of uncertainty associated with protracted and expensive litigation. The settlement allows us to move ahead with our important work of helping improve the health of millions of Americans.

“HDL, Inc. will continue to participate in all federal healthcare programs, including Medicare, Medicaid and TRICARE. As part of the settlement, HDL, Inc. will further develop and strengthen its robust compliance program in accordance with a five-year corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services.

“We emphasize that reaching this agreement does not mean that HDL, Inc. engaged in any wrongdoing. The settlement is not an indication that any conduct was improper or unlawful. As DOJ noted in its news release announcing the settlement, ‘The claims settled by these agreements and asserted against these companies and individuals are allegations only, and there has been no determination of liability.’ We have consistently sought to comply with all applicable legal and regulatory requirements, and are committed to continuing to do so. HDL, Inc. is proud of its work to help revolutionize patient care by changing the way that cardiovascular disease, diabetes, and related conditions are diagnosed and treated.”

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