News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Could McKesson Settlement Set a Precedent That Would Require Clinical Laboratories to Track Physician Test Ordering?

McKesson agreed to pay a $150 million settlement for not reporting suspicious opioid orders and this case establishes a precedent that could ensnare other providers

In today’s world of the Internet-of-Things, it is becoming easier to collect data on every purchase made by individuals and companies. That ability to track the actions of consumers and commercial business has not escaped the notice of law enforcement and regulatory authorities. For example, at some future point, it could be that regulators would want to access data held by clinical laboratories on the test ordering patterns of their client physicians.

A recent ruling by the US Department of Justice (DOJ) in a case involving McKesson Corp. (NYSE:MCK), may set a precedent that could eventually be cause for concern for medical laboratories that work with physicians who may be ordering more tests than are considered medically necessary under current regulations.

McKesson is a retail distributor of pharmaceuticals, and provider of health information and care management technologies and medical supplies. In a settlement with the DOJ, McKesson agreed to pay a record $150 million in civil penalties, as well as a staggered suspension of sales of controlled substances for a period of time from distribution centers in Colorado, Ohio, Florida, and Michigan, for alleged violations of the Controlled Substances Act (CSA). (more…)

More Doctors to See Jail Time in Biodiagnostic Laboratory Services Case, but Question Remains: Will Federal Prosecutors Send Lab Executives and Doctors to Jail in the Health Diagnostics and Singulex Case?

Recent federal Justice Department memorandum issues guidance designed to seek accountability from individuals and combat corporate misconduct

Pathologists and clinical laboratory managers who want a tougher crackdown on labs and physicians that violate anti-kickback laws welcome the news that in the past year federal courts have sentenced 13 physicians to jail terms of 12 to 63 months for accepting bribes from a discredited medical laboratory company as part of a scheme to defraud the federal Medicare program.

These criminal convictions were part of the federal case prosecuted against Biodiagnostic Laboratory Services (BLS), in Parsippany, N.J..

In addition to those 13 jail sentences, one doctor got 10 months of home confinement, two doctors got 12 months probation, and sentencing for six other physicians is pending. Prosecutors expect more defendants will be sentenced in the coming months. (more…)

DOJ Names Individuals in Suit against Health Diagnostic Laboratory, Sales Consultants, and Two Other Medical Laboratory Companies

In special issue, The Dark Report explains the details of what may be the biggest case of Medicare fraud and abuse in the history of the clinical laboratory business

Many clinical laboratory executives and pathologists know about the settlement last March by the Department of Justice (DOJ) of a whistleblower case involving Health Diagnostic Laboratory and Singulex. But that settlement is just one part of this major fraud case that continues to move forward and in which federal prosecutors alleged that a group of plaintiffs defrauded the federal Medicare and Tricare program out of half a billion dollars, in just 60 months!

In a court filing last summer, federal attorneys described how the lab companies and lab executives were paid $500 million between 2010 and 2014 from lab test claims submitted to the Medicare and Tricare programs. This federal lawsuit named three medical laboratory companies and three individuals as defendants. They are: Health Diagnostic Laboratory, Singulex, Berkeley HeartLab (no longer in business), BlueWave Healthcare Consultants, Tonya Mallory, Floyd Calhoun Dent, III, and Robert Bradford Johnson. (more…)

Health Diagnostic Laboratory Puts Itself Up for Sale as Virginia Medical Lab Company Solicits Bids for Auction

HDL also got approval to question executives from UnitedHealthcare in court over unpaid claims, its third dispute with a health insurance company

Following a string of major setbacks, Health Diagnostic Laboratory (HDL) of Richmond, Virginia, put itself up for sale last week. This action comes after HDL’s announcement in April that it would pay more than $100 million to settle charges with federal investigators that it violated the False Claims Act. Then, early last month, the clinical laboratory company filed for bankruptcy protection.

On Tuesday, July 14, U.S. Bankruptcy Court Judge Kevin R. Huennekens approved HDL’s request to put itself up for sale through a court-monitored auction, the Richmond Times-Dispatch reported. No potential buyer has been named, but the clinical laboratory company has businesses that are interested in acquiring HDL, the Times-Dispatch added. (more…)

Wall Street Journal Writes about Federal Investigation of Health Diagnostic Laboratory and Certain Specialty Medical Lab Test Companies

Did “processing fees” paid by certain clinical laboratory companies to physicians represent an inducement that violated federal anti-kickback laws?

Once again, allegations of fraudulent practices at a fast-growing clinical laboratory company have made national headlines. This time it was a front-page story in The Wall Street Journal (WSJ) that last week discussed the controversy surrounding Health Diagnostic Laboratory (HDL) of Richmond, Virginia.

According to the WSJ story, federal healthcare authorities are looking into a practice by HDL and other medical laboratory companies of paying physicians “to process” blood specimens collected in their offices. As described by the WSJ, this “processing fee” was as much as $20 and included a $3 portion for the venipuncture. (more…)

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