FOR IMMEDIATE RELEASE AG Monday, February 24, 1997 (202) 616-2765 TDD (202) 514-1888 DOJ AND HHS HIGHLIGHT LATEST EFFORTS TO FIGHT FRAUD BY CLINICAL LABORATORIES Operation "LabScam" Yields Big Results Including Second Largest Health Care Fraud Settlement Ever WASHINGTON, DC -- The federal government's fourth major case targeting fraud by independent clinical laboratories has brought the total amount recovered by laboratory enforcement initiatives to more than $800 million and resulted in three corporate criminal convictions, announced Attorney General Janet Reno and Health and Human Services Inspector General June Gibbs Brown today. Reno said that SmithKline Beecham Clinical Laboratories (SBCL) today entered into the second largest health care fraud settlement in history. Brown also described new guidance issued by HHS today to help independent clinical laboratories create compliance programs. The case against SBCL, which arose out of their performance of clinical laboratory services for patients whose services are paid for in whole or in part by the federal government, was investigated and coordinated by the United States Attorney's Office for the Eastern District of Pennsylvania. Under the settlement, SBCL paid $325 million to resolve the civil allegations. SBCL also committed to adopt a corporate compliance agreement. "Laboratory enforcement initiatives including LabScam have recovered approximately $800 million and convicted three corporations of criminal fraud," said Reno. "Now, all three major independent laboratories are operating under extensive corporate integrity agreements that are designed to prevent the abuse from occurring again." Brown said that the enforcement efforts of the past four years had led to a substantial reform in the laboratory industry and broken new ground in terms of voluntary corporate compliance, even absent corporate integrity agreements. "Today we are unveiling the first of several compliance plans that are intended to help health care providers doing business with the Federal Government to better protect their own operations and the Medicare and Medicaid programs against fraud and abuse," Brown said. "From my perspective, the adoption of a compliance plan is an affirmative step toward promoting a high level of ethical and lawful corporate conduct and preventing future scams." Health and Human Services Secretary Donna Shalala said LabScam is a "clear success story" and vowed continued commitment. "When I took office more than four years ago, I set a policy of zero tolerance' for health care fraud and abuse and made it a top priority," said Shalala. "We will continue to work with the Department of Justice to put an end to this kind of payment fraud that robs our health system and our taxpayers." Reno stressed that while voluntary compliance was the expectation and goal of the federal government, investigations and prosecutions would continue to be important tools. "We expect businesses to take these steps on their own initiative, before any unlawful conduct occurs. But to medical laboratories who ignore this advice, our warning is clear -- we will bring the full weight of the federal government's powers to bear to enforce the law and protect the American people from being ripped off." Operation LabScam Operation LabScam was launched following the Federal Government's 1992 prosecution of National Health Laboratories, Inc. (NHL) for submitting false claims to the Government. During the course of the two-year investigation of NHL, it became apparent to government attorneys and investigators that other companies in the laboratory industry were engaged in the same or similar practices, which included billing Medicare for millions of unnecessary tests, while misleading the physicians who purportedly "ordered" the tests into thinking that the tests would be performed for free. Shortly after the NHL settlement, the Department formed a working group of federal and state investigators, and civil and criminal prosecutors. LabScam operated under three simple tenets: full investigations of the laboratories to address any and all violations of civil and/or criminal laws; centralized, focussed audit work with the cooperation of HCFA, and; coordination among DOJ, U.S. Attorneys Offices, Medicaid Fraud Control Units, investigative agencies, and federal benefits programs. HHS simultaneously issued Inspector General subpoenas to a number of national clinical laboratories whom the working group had reason to believe were engaged in the same kind of marketing and billing scheme to which NHL had just pled guilty. The companies targeted included some of the largest independent clinical laboratories in the country. SmithKline is the third major laboratory case brought under the LabScam Initiative. On October 10, 1996, Damon Clinical Laboratories, Inc. pled guilty in Boston federal court to conspiracy to defraud Medicare and pay $119 million in criminal fines and a civil settlement. Damon's then-parent corporation, Corning, Inc., also agreed to enter into a revised corporate integrity agreement. On November 21, 1996, Allied Clinical Laboratories, San Diego Regional Lab, pled guilty to submitting false claims to Medicare and Medi-Cal, and Roche Biomedical Laboratories agreed to enter into a pretrial diversion program. Their successor corporation, Laboratory Corporation of America, agreed to pay $187 million in criminal fines and a civil settlement for conduct by Allied Clinical Laboratories, Roche Biomedical Laboratories, and National Health Laboratories. The Laboratory Corporation of America also agreed to enter into a corporate integrity agreement. ### 97-082