Health Diagnostic Laboratory in Richmond, Virginia, has reached a settlement agreement with federal investigators over allegations that HDL paid doctors to „treat“ blood samples collected from their offices. The „treatment tax“ included a $3 portion for venous puncture, the Wall Street Journal reported. (Photo Copyright The Richmond Times-Dispatch.) As part of the DOJ settlement agreement, HDL could have to pay up to $100 million, according to a report released by Forbes last month, which said federal negotiators will enter into similar agreements with other lab companies, which are mentioned in the WSJ article in September. These laboratories are Atherotech Diagnostics Inc. in Birmingham, Alabama, and Boston Heart Diagnostics Corp. in Framingham, Massachusetts, the WSJ reported. Each of the labs denied the allegations and said they were working with investigators, the WSJ reported. Singulex also issued a statement stating that „the investigation focused on the payment of procedural and processing costs, which was an industry practice,“ that it disputed any wrongdoing and that it had reached an agreement with the DOJ to fully resolve the investigation and avoid lengthy and costly litigation. „The company is confident in its business practices and the value that its products and services offer customers,“ said Singulex. It is important that the claims settled by this agreement are merely allegations and no declaration of liability has been made. Quest has denied any misconduct and says computer problems have influenced Medicare`s reimbursement of some test codes.
This situation led to double payments to the company. Quest says it has update systems to prevent this from happening again. (see the capital`s public radio) As part of the criminal decision, NID pleaded guilty today before U.S. District Judge Sterling Johnson Jr. in Brooklyn to a crime charged in violation of food, drug and cosmetic law with respect to the NID Nichols Advantage Chemilumines Chemilumines, Immunoassay, a test used by laboratories across the country to measure parathyroid hormone (PTH) in patients. As part of the plea, NID will pay a $40 million fine. Quest also entered into a non-persecution agreement with the United States. WASHINGTON – Quest Diagnostics Incorporated and its subsidiary Nichols Institute Diagnostics (NID) have entered into a comprehensive transaction with the United States to resolve criminal and civil claims relating to various types of diagnostic tests that NID produced, marketed and sold to laboratories across the country until 2006, as announced today by the Department of Justice. The $302 million payment will shed light on these allegations and represents one of the largest recoveries ever made in a case involving a medical device.