–Yet more fallout from the catastrophic bankruptcy of HDL Lab The Zombie Lab case just got even messier. Last Friday the trustee for the bankrupt Health Diagnostic Laboratory (HDL) filed a massive lawsuit against the former executives, owners, sales force members, and others who profited from HDL. The 205-page lawsuit includes a detailed narrative of…
The Billion Dollar Lab Scandal
July 18, 2016 by Leave a Comment
If you think Theranos is a big story then I have some news for you. There’s another medical laboratory scandal that dwarfs the Theranos story by almost any standard except for hype. The Theranos story is an important sexy Silicon Valley story. It’s more about an imagined shimmering future than about the greasy present we actually…
The Wild West Of New Laboratory Scams
July 11, 2016 by 34 Comments
It’s like the wild west. With no sheriff acting to impose law and order, many laboratory companies are now deploying a wide variety of new scams to gain new business. The new scams have emerged in the wake of the collapse and bankruptcy of Health Diagnostics Laboratory (see the bottom of this story for links to previous coverage)…
US DOJ Expands Investigation Into Phony Novartis Speaking Events
March 29, 2016 by 1 Comment
— The government wants Novartis to turn over documents on 80,000 separate speaking events. The US Department of Justice is seeking to greatly expand its investigation of Novartis “for engaging in a nationwide kickback scheme, spanning 10 years, to induce doctors to write prescriptions for certain of its cardiovascular (‘CV’) drugs.” Last week the DOJ…
Trick Or Treat? Hospitals, Haunted By DOJ ICD Investigation, Settle For $250 Million
October 30, 2015 by Leave a Comment
The specter of the US government investigation into hospital overuse of ICDs has now finally been dismissed. The investigation, which has haunted hospital executives and electrophysiologists since it began in 2011, was finally resolved on the day before Halloween. With a $250 million treat for the government the hospitals have now finally managed to get the unwelcome trick or treaters…
DOJ May Soon Announce Settlements With Hundreds Of Hospitals Over ICD Overuse
September 29, 2015 by Leave a Comment
The US Department of Justice may be getting ready to announce that hundreds of hospitals have settled with the government in response to a lengthy investigation over ICD (implantable cardioverter defibrillator) overuse, according to an article by Lisa Schencker in Modern Healthcare. “The U.S. Justice Department may announce in the coming weeks what may be the largest False Claims Act…
Embattled Laboratory Files For Bankruptcy
June 8, 2015 by Leave a Comment
Health Diagnostic Laboratory, Inc., the embattled lab company, has filed for chapter 11 bankruptcy. The once high flying company, which was founded in 2009 and achieved annual revenue of more than $400 million in a few short years, has been beset by scandal and legal difficulties. Most recently, the US Department of Justice announced that it had reached a…
Inside The Scandal: Profit And Greed At An Embattled Laboratory Company
April 21, 2015 by Leave a Comment
How does a clinical laboratory company grow in a few short years from nothing to more than $400 million in revenue and over $100 million in profit? Since the same company just settled with the DOJ for as much as $100 million, it’s reasonable to suspect that growth was probably not entirely legitimate. Now new information,…
DOJ Settles With Embattled Lab, Criminal Charges For Executives Still Possible
April 10, 2015 by Leave a Comment
In line with reports last month, Health Diagnostic Laboratory Inc, the embattled lab company, has reached a settlement with the Department of Justice following a lengthy investigation into the company’s business practices, which include giving kickbacks to physicians and additional illegal sales, marketing, and billing practices. HDL will initially pay at least $47 million to the government. … Note to readers: I have received…
Embattled Lab Nears Settlement With Government Over Kickbacks
March 24, 2015 by Leave a Comment
Health Diagnostic Laboratory Inc, the embattled lab company, is nearing a $50 million settlement with the Justice Department, according to a Wall Street Journal story by John Carreyrou. As previously reported here, the federal government is investigating HDL for giving kickbacks to physicians who use the company’s tests. Additional allegations suggest a broader pattern of serious misconduct based on questionable sales,…
Aegerion Warns About Negative Impact Of DOJ Investigation
March 5, 2014 by Leave a Comment
Earlier this week in its annual report Aegerion Pharmaceuticals provided an update on its ongoing problems with the FDA and the Department of Justice. As previously reported here and on The Street and on CNBC, the company landed in hot water with the FDA last year after its CEO made a series of off-label statements on the CNBC Fast Money show. (The company’s only product, Juxtapid…
DOJ Investigating Abiomed For Improper Marketing Of Impella Circulatory Support System
November 1, 2012 by Leave a Comment
Cardiovascular device maker Abiomed announced that the US Attorney’s Office was investigating the company’s marketing and labeling of the Impella 2.5 circulatory support device. The announcement confirmed rumors that had been circulating for at least two weeks, though in the press release the company said it had been informed of the investigation on October 26….
ICD Investigation: DOJ Sends Resolution Model To Hospitals
August 30, 2012 by 1 Comment
Hospitals across the country received emails from the US Department of Justice on Thursday containing a proposed “Resolution Model” that will allow the hospitals to begin to settle the long-standing and much-feared DOJ investigation into improper Medicare billing for ICDs. The action appears to confirm an article, published earlier in August in Report on Medicare…
Guest Post: Feds Turn Corner in ICD Investigation; Hospital Liability Divided into Categories
August 7, 2012 by Leave a Comment
Editor’s Note: The following article is reprinted with permission from Report on Medicare Compliance, an independent publication not affiliated with hospitals, government agencies, consultants or associations and published by Atlantic Information Services, Inc. The Department of Justice is apparently about to take a big step forward in its national false claims investigation of Medicare billing for implantable…
DOJ Investigating Interventional Cardiology Services At HCA
August 6, 2012 by Leave a Comment
The hospital giant HCA has disclosed that the US Attorney’s Office in Miami is investigating the company and has “requested information on reviews assessing the medical necessity of interventional cardiology services provided at any Company facility (other than peer reviews).” Following its own preliminary investigation, the company said it was aware of such reviews in about…
HRS 2012: More Clarity on DOJ ICD Investigation, “Incidental PCIs” Still Excluded
May 12, 2012 by Leave a Comment
In a guest post, electrophysiologist Edward J. Schloss recounts a talk at Heart Rhythm Scientific Sessions 2012 by Suneet Mittal which provided a detailed account of his group’s experience with a Department of Justice investigation of ICD implantation outside of NCD guidelines….
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