HDL, Inc. Reaches Settlement Agreement with DOJ

Agreement does not mean HDL, Inc., engaged in any wrongdoing; allows HDL, Inc. to move ahead with important work of helping improve health of millions of Americans

RICHMOND, Va. (April 9, 2015) – The following may be attributed to Health Diagnostic Laboratory (HDL, Inc.):

“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 announcing the settlement, 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.

“Under the new leadership of President and Chief Executive Officer Joe McConnell, Ph.D. since September 2014, HDL, Inc. has taken decisive actions to return to its core mission of fighting cardiovascular disease and diabetes with innovative, advanced testing that can lead to earlier diagnosis and treatment. HDL, Inc. has eliminated certain non-core business initiatives, streamlined the company’s work force, and added two new Board members with significant medical and business expertise in the advanced diagnostic testing industry. Additionally, HDL, Inc. announced on Jan. 9, 2015 that it was establishing a new national network of directly-employed sales representatives who will bring an unsurpassed knowledge and enhanced focus on HDL, Inc.’s comprehensive laboratory testing. As part of this sales force transition, HDL, Inc. terminated its contract with the independent sales organization BlueWave Healthcare Consultants, Inc. (Blue Wave).

“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.”

About Health Diagnostic Laboratory, Inc.
Founded in 2008, Health Diagnostic Laboratory, Inc. (HDL, Inc.) is a leader in health management with one primary mission: prevent and reverse heart disease and diabetes, one patient at a time. The company offers a comprehensive test menu of biomarkers that can indicate risk for cardiovascular disease, diabetes, and related diseases. HDL, Inc.’s systematic approach identifies factors contributing to disease and provides a basis for effective treatment, allowing healthcare providers to better manage the health of their patients. In addition to lab testing, HDL, Inc. offers patients a personalized overview of risk factors and assistance from expert Clinical Health Consultants to promote healthy, longer-lasting lifestyles. The company also provides comprehensive testing and wellness services to employers and is a partner for value-based, integrated care models and health systems. HDL, Inc. is a CLIA-certified, CAP-accredited laboratory. For more information, visit myHDL.com, and make HDL, Inc. part of your digital lifestyle at Facebook.com/myhdl and on Twitter @hdltweets.

MEDIA CONTACT: Doug Sbertoli at dsbertoli@hdlabinc.com or (804) 343-2718 ext. 1635.

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