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Clinical Lab Settlements Reflect Future Government Enforcement Actions

The Whistleblower initiated case against National Health Laboratories ("NHL") in 1992 resulted in the criminal conviction of officials of NHL and an $111 million civil recovery by the Federal government. This case triggered "copy cat" enforcement actions against numerous additional national clinical laboratories resulting in the recent criminal conviction and civil settlements with Damon and SmithKline Beecham clinical laboratories totalling $450 million in recoveries for the Federal government.

The government used the cumulative information which it obtained from its own ivestigatory efforts and information brought forward to them by whistleblowers in initial "clinical lab" cases to bring subsequent enforcement actions against other clinical laboratories involving the same practices. The results include criminal convictions and settlements with as many as 12 national clinical laboratories with more actions pending throughout the country. The government's practice has been to identify the kinds of fraudulent and abusive practices in a particular segment of the industry. Once this is completed then the government will scrutinize other providers and suppliers in that segment of the industry with the possibility that they will become targets or subjects of the investigation. This typically results in the initiation of negotiations which result in a settlement of criminal and civil liability largely obtained by the government's considerable leverage under these circumstances (i.e. individual and corporate criminal and civil liability, triple damages and exclusion from the Medicare and Medicaid programs).

The government's continuing efforts to enforce the health care fraud and abuse laws will focus this methodology for enforcement on other segments of the health care industry. This is especially true where certain fraudulent and abusive practices have already been identified, including, but not limited to, durable medical equipment suppliers, mail-order pharmaceutical suppliers, especially those for respiratory and oxygen equipment, inpatient and outpatient mental health services and home health agencies. The government's efforts have only begun to have their effect and it is expected that increased funding for enforcement activity and personnel will intensify scrutiny in these areas.

The current enforcement actions which have resulted in large recoveries by the government have had a significant impact on these segments of the industry. It can be expected that the government will continue to attempt to bully providers and suppliers into criminal pleas and civil settlements in circumstances which may not be possible if these issues were adjudicated in a fair forum. However, the prospect of "rolling the dice" in a fair forum where the chances of prevailing can by no means be assured is not a viable alternative for many providers and suppliers, especially those who are publicly traded or seek to continue providing services in the Medicare and Medicaid programs.

If the government comes knocking on your door, contact competent counsel quickly so that an appropriate response can be formulated concerning these types of matters.

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