Issues Archive

The most complete archive of clinical and pathology lab industry news available, including issues from 1997 to the present.

Volume XXIV No. 16 – November 20, 2017

In this issue:

HERE AT THE DAWN of the new era of value-based healthcare, THE DARK REPORT has uncovered a new trend: The diverging paths of hospital labs and independent lab companies that will severely test the endurance of the independents, radically alter ancillary industries and create fierce new competition among specialty labs. Also in this issue is exclusive analysis of the possibility of upcoming Medicare Part B lab test fee cuts causing big lab companies to try to negotiate higher prices with private health insurers.

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Volume XXIV No. 15 – October 30, 2017

In this issue:

IN THIS ISSUE, THE DARK REPORT breaks the news that growing numbers of hospitals are being asked to enter into a “hospital outpatient department” billing arrangement involving lab testing — arrangements that push the limits of federal and state statutes. One common attribute of these HOPD schemes is that the organizers want the hospital, as an in-network provider, to bill for all the lab tests performed in the organizers’ labs. The hospital and the HOPD organizers then split the payments from payers.

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Volume XXIV No. 14 – October 9, 2017

In this issue:

IT’S TIME TO ACT: This issue of THE DARK REPORT is devoted entirely to the looming laboratory fee cuts called for by the Protection of Access to Medicare Act — driven by flawed data — that will cause “significant harm” to the lab industry and all patients who depend on it. This issue delivers exclusive analysis of the fast-approaching crisis, and urges pathologists and lab managers to submit comments to CMS by October 23, and also to contact Senators and Representatives, urging a delay in implementation of the fee cuts.

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Volume XXIV No. 13 – September 18, 2017

In this issue:

IS THIS A SIGN that the rampant fraud and abuse within the toxicology laboratory testing sector may finally be seeing its day of reckoning by federal prosecutors, the media, and private payers? THE DARK REPORT reports on two such companies that have been accused of massive fraud and are are fighting to stay in business. At the same time, another toxicology lab has developed a DNA-authentication method that alerts the lab to cheaters on urine tests.

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Volume XXIV No. 12 – August 28, 2017

In this issue:

THE ERROR MAY ONLY AFFECT A FEW PATIENTS, but Invitae’s failure to test for the Boland Inversion across some 50,000 patients may set a record for such an error. THE DARK REPORT broke the news of this mistake, and in this issue delivers analysis of the fallout, including the fact that Invitae’s assays are laboratory-developed tests (LDTs), which the FDA has been pushing to regulate for the past three years. Also in this issue, TDR discusses the costs for redoing genetic tests, and Invitae’s push to expand its market share.

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Volume XXIV No. 11 – August 7, 2017

In this issue:

WITH ONLY A FEW MONTHS REMAINING before CMS implements lab fee cuts that will shake the industry to its core, THE DARK REPORT delivers exclusive analysis of the industry’s options to fight back, the reasons why the PAMA rule is flawed, and even how these flaws are believed to have developed when the Protecting Access to Medicare Act was passed in 2014.

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Volume XXIV No. 10 – July 17, 2017

In this issue:

IN AN EXCLUSIVE INTERVIEW, Ambry Genetics’ CEO shares details about the clinical and market strategies that led Ambry to become the target for one of the biggest lab acquisition deals in recent years by purchase price, and one of the highest-priced acquisitions of a privately-held lab company. Also, laboratory executives and pathologists preparing for 2018’s looming $400 million in Medicare Part B fee cuts will learn from this issue about the inherent bias included in the PAMA final rule that will work to the disadvantage of their labs.

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Volume XXIV No. 9 – June 26, 2017

In this issue:

FOR LAB MANAGERS WORRIED about being parceled out to a national lab, news reports that Quest Diagnostics had exited the long-running CompuNet Clinical Laboratory joint venture in Ohio is intriguing. THE DARK REPORT provides exclusive analysis of that news, provides a history of the lab joint venture, and considers the possibility of a trend in lab agreements with Quest. Also, this issue includes analysis of the trend in genetic testing pre-authorization and its impact on local labs.

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Volume XXIV No. 8 – June 5, 2017

In this issue:

IT’S A STARTLING ACHIEVEMENT: A Silicon Valley-based lab company, just two years after its founding, has become an in-network lab provider for a number of health insurers—including three of the nation’s largest payers, gaining in-network access to 100 million members. How did the firm do it? By establishing a rock-bottom price of $249 for its 30-gene test panel and building a physician-friendly portal that makes it quick and easy for doctors to meet pre-authorization requirements when ordering the test. In another article, THE DARK REPORT explains why it’s past time for labs to make more money by helping to improve outcomes — that is, adopting Clinical Lab 2.0 for the future.

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Volume XXIV No. 7 – May 15, 2017

In this issue:

IT’S GOOD NEWS AND BAD NEWS for the laboratory industry, as attested to by industry leaders at the Dark Intelligence Group’s annual Executive War College. Speakers explained in detail how the rise of precision medicine will bolster labs, and how looming Medicare cuts will hurt them. Innovation in business models is on the table, and detailed in depth by the experts in this issue.

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CURRENT ISSUE

Volume XXXII, No. 6 – April 21, 2025

Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.

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