Issues Archive

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

Volume XXVIII, No. 1 – January 19, 2021

In this issue:

THE DARK REPORT HAS DiSCOVERED that 3 major health systems with 372 hospitals have switched to a different CLIA accreditation organization over the past 18 months. All the details are examined here, including reasons why a health system might make such a switch. Also in this issue is an exclusive newsmaker interview with the CEO of a new company that is challenging the 70-year-standard Coulter Principle technology in hematology.

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Volume XXVII, No. 18 – December 28, 2020

In this issue:

There are several surprises in The Dark Report’s annual list of the Top 10 Lab Stories for 2020. Despite the SARS-CoV-2 pandemic dominating every aspect of clinical care, social life, and economic activities since March, at least one major health insurer pushed ahead with two major policies governing how labs can submit claims. In another big story, for the first time in decades, the federal Anti-Kickback Statute and the Stark Law were revised with new final rules. Also, Medicare lab test spending increased in 2019 despite PAMA cuts.

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Volume XXVII, No. 17 – December 7, 2020

In this issue:

IN A SURPRISING AND INSPIRING story, a Maine lab executive shares how his lab began preparations for COVID-19 in December 2019. Another lab’s story of pivoting from pathology testing to COVID-19 testing is equally instructional. And in other news, one CPT code has been used so often and for such high payments, it’s earned the title “fraudomatic” from an expert observer.

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Volume XXVII, No. 16 – November 16, 2020

In this issue:

UNWELCOME CHANGES to how labs do business are forcing labs to cope with high demand for COVID-19 testing while dealing with government and private payers interfering with normal operating procedures. Medicare has new requirements and payment rates for COVID-19 tests. Also reported here are UnitedHealthcare’s new Laboratory Test Registry Protocol, and California’s new COVID-19 testing laboratory that is diverting lab instruments, supplies, and test kits away from hospital and independent labs in the state. 

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Volume XXVII, No. 15 – October 26, 2020

In this issue:

INDUSTRY LEADERS SHARE THEIR CONCERNS over CMS’ planned cuts to COVID-19 test payments and discuss their proposed strategies for COVID testing. Also, a pathology group reports lessons learned the hard way when it opened a brand-new clinical lab in the midst of the worst of the pandemic.

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Volume XXVII, No. 14 – October 5, 2020

In this issue:

THE DARK REPORT HAS ANALYSIS showing potential reasons why the Department of Justice has generated its largest lab fraud crackdown in history. $6B in allegedly fraudulent claims and 345 defendants may well be the result of an explosion in molecular test claims in 2019. Also, another competitor has entered the lab marketplace, this time with portable COVID-19 testing labs in trailers.

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Volume XXVII No. 13 – September 14, 2020

In this issue:

THE DARK REPORT IS VIEWING THE FUTURE of the lab industry, and it’s clear that things will be different post-pandemic. Four trends will take shape in the coming months and years which lab professionals must bear in mind as they wrestle with everything the pandemic has wrought. Also, lab industry entrepreneurs are leveraging the pandemic situation in ways that lab managers must be aware of in order to secure their organization’s own position in the industry.

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Volume XXVII, No. 12 – August 24, 2020

In this issue:

THE DARK REPORT lines up its top lab industry experts to analyze a surprising development: The department of Health and Human Services’ welcome announcement that the Food and Drug Administration does not need to issue an Emergency Use Authorization for laboratory-developed tests. This announcement is significant because EUAs for LDTs have been a long-running irritant to labs. But lab managers will want to consider whether liability issues make a voluntary EUA advisable, based on TDR’s analysis.

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Volume XXVII, No. 11 – August 3, 2020

In this issue:

WILL RETAIL BEHEMOTH AMAZON become a competitor in the clinical lab industry? With its plans to build COVID-19 testing labs and history of disrupting the marketplace, this is a distinct possibility, and it’s not just THE DARK REPORT that thinks so. Also, UHC is about to do some disrupting of its own with its new test code protocol.

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Volume XXVII No. 10 – July 13, 2020

In this issue:

IS POOLED TESTING the answer to COVID-19 testing shortages? Yes and no. THE DARK REPORT analyzes the pros and cons of this suddenly-popular old idea, with experts from across the industry offering their input. Also in this issue is the case for why local labs should be getting more testing supplies, and how the government has damaged the supply chain.

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