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Issues Archive

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

Volume XXIV No. 2 – January 30, 2017

In this issue:

THE CLASH BETWEEN the benefits versus costs of pharmacogenomics — supposedly the wave of the future because of its role in personalized medicine — is highlighted by two contrasting, in-depth reports in this issue of THE DARK REPORT. One health system successfully leverages it to radically improve patient outcomes, while two others have been slammed with massive recoupment demands on the grounds that such tests are medically unnecessary, as reported first in THE DARK REPORT. Also, THE DARK REPORT steps out at the front of a new movement toward an entirely new lab business model: Clinical Laboratory 2.0.

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Volume XXIV No. 1 – January 9, 2017

In this issue:

IN A MUST-READ, IN-DEPTH ANALYSIS, THE DARK REPORT reports on a $26 million repayment demand faced by a pioneer in the fields of exome sequencing and pharmacogenomic testing — and just as clinical labs and pathologist have always feared, it comes from an audit by a private auditor under the Medicare Zone Program Integrity Contractor (ZPIC) program. With Chapter 11 bankruptcy facing the company, all laboratorians must understand the power of the auditor going forward, especially if this is a sign that ZPIC audits will be more aggressive in the future.

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Volume XXIII, No. 17 – December 19, 2016

In this issue:

THE DARK REPORT’S ANNUAL TOP 10 for the year delivers a must-read review of the trends and developments that shook up the clinical laboratory industry, including the flaming collapse of Theranos and the PAMA final rule that promises severe Medicare fee cuts and the potential for labs to simply go out of business. Also, the impending arrival of BeaconLBS in Texas will set up a cutthroat price competition for labs there.

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Volume XXIII No. 16 – November 28, 2016

In this issue:

THIS ISSUE, THE SECOND SPECIAL ISSUE dedicated to the PAMA Final Rule, delivers expert analysis of the probable impact of coming Medicare cuts, which includes the possible demise of a sizeable number of community labs, rural hospitals, and community hospitals. THE DARK REPORT also has an exclusive examination of the multitude of errors that many reporting labs are almost certain to find in their data, advising on avoiding these issues; discusses the merits of a court challenge to the Final Rule; and gives an update on similar data reporting in California.

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Volume XXIII No. 15 – November 7, 2016

In this issue:

THIS SPECIAL ISSUE OF THE DARK REPORT delivers the lab industry’s first credible look at the actual private payer lab test price data that four categories of labs will report to CMS under PAMA. This is a DARK REPORT exclusive and gives labs an absolutely critical understanding of the real differences between what private health insurers pay for lab tests and what Medicare Part B CLFS prices are. Included are data showing that private payers pay considerably less than Medicare. What’s more, THE DARK REPORT has calculated that potential CMS fee cuts for 2018 could total $400 million.

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Volume XXIII No. 14 – October 17, 2016

In this issue:

IT WON’T BE WELCOME NEWS to clinical labs and pathology groups in Texas — and around the country — that UnitedHealthcare will introduce its laboratory benefit management program in the Lone Star State. THE DARK REPORT’s exclusive analysis shows how the move will change the access many labs have to UHC patients and probably reduce the money these labs are paid if and when they do perform testing for UHC patients — and perhaps generate the same opposition that it has in Florida. Also in this issue is a detailed analysis of how clinical labs and pathology groups will need to align their diagnostic services to meet the changing needs of hospitals and providers in order to continue generating revenue.

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Volume XXIII No. 13 – September 26, 2016

In this issue:

IT’S NEVER BEEN DONE BEFORE: In a story reported to the laboratory industry only in THE DARK REPORT, and for the first time ever in a case of alleged lab fraud, the bankruptcy trustee in the Health Diagnostics Lab case is seeking the return of all funds that changed hands illegally — from HDL executives, shareholders and sales consultants, to the physicians who accepted inducements from the company. Also, the lab profession will be surprised to learn of attorney Jane Pine Wood’s departure from private practice to work for a corporation, leaving hundreds of clients without her respected and expert legal acumen.

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Volume XXIII No. 12 – September 6, 2016

In this issue:

THE DARK REPORT IS THE ONLY RESOURCE IN THE INDUSTRY to both recognize the immense significance to the entire lab industry of the Safeway reference pricing program — and how it drove down the cost of lab testing to Safeway and its employees by 32% in just 36 months — and to provide a “take-to-the-bank” comprehensive analysis of the study in JAMA Internal Medicine that delivers all the implications of reference pricing. This issue is designed to help Dark Intelligence Group members craft appropriate strategies for their organizations so they can respond to this latest threat to laboratory revenue if and when it arrives in their communities.

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Volume XXIII No. 11 – August 15, 2016

In this issue:

THE DARK REPORT WAS ON THE SCENE when Elizabeth Holmes made her big debut in front of industry scientists, and analyzes the reaction in this issue. Also, THE DARK REPORT has uncovered the latest threat to incomes for anatomic pathologists, as a new reimbursement scheme via MACRA is set to launch in January; and the issue also includes insights and predictions about how pathologists should understand and respond to several other important pathology marketplace developments.

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Volume XXIII No. 10 – July 25, 2016

In this issue:

BY NOW, MANY LAB PROFESSIONALS KNOW CMS sent a letter to Theranos in early July that imposed multiple CLIA sanctions on the beleaguered laboratory company. In this issue, THE DARK REPORT provides informed analysis, along with its expert prediction that Theranos may be preparing to abandon its clinical lab testing and direct-to-consumer strategies in favor of a new strategy involving in vitro diagnostics (IVD). Also in the issue is an exclusive interview with two attorneys recognized for their expertise in clinical lab laws and compliance, who note that the Theranos letter differs markedly  from other lab sanction letters they have seen − and seems to give Theranos some surprising options.

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CURRENT ISSUE

Volume XXXIII, No. 4 – March 23, 2026

A federal court ruling has established a safe harbor for clinical labs when they run tests ordered by physicians. Lab leaders should examine this briefing for pitfalls. Also, it turns out that providers may be ordering inappropriate vitamin D tests, according to one expert.

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