Issues Archive

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

Volume XXVI No. 1 – January 14, 2019

In this issue:

LAB ADMINISTRATORS AND PATHOLOGISTS should pay close attention to emerging new disruptive forces outlined in this issue — and their potential to upend the clinical laboratory industry as it exists today. From slashed Medicare prices, to the risk of $10,000-per-day penalties for PAMA price-reporting errors, to narrowing networks, 2019 will be one of the most challenging years facing the clinical lab industry since the early 1990s. At the same time, THE DARK REPORT details five specific strategies from a highly-respected lab industry executive that administrators can leverage to survive and thrive in the storm.

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Volume XXV No. 18 – December 24, 2018

In this issue:

THE NEW YEAR will be a challenging one for clinical labs and pathology groups, based on significant events of the last year. For one: If your hospital is marked under the PAMA law as having “applicable” labs, you’ll be struggling to comply with reporting private payer lab price data. Meanwhile, all labs will face tougher anti-fraud rules, and common pass-through billing practices may prompt private payers to sue. These issues and more are reviewed in this issue, including expert guidance for lab managers on navigating the various minefields.

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Volume XXV No. 17 – December 3, 2018

In this issue:

DID CONGRESS JUST PASS A LAW that makes innocent labs guilty of criminal acts? At the last minute, Congress added all clinical laboratories to a far-reaching anti-kickback provision in the newly-enacted Support for Patients and Communities Act — a provision that makes common practices such as paying commissions to sales staff or placing phlebotomists in labs could be illegal. Worse: The experts are baffled by the language of the new law. Notes one of these experts in this issue, “Someone in the clinical lab industry may have to get prosecuted before we get some clarity, unless the Secretary of HHS issues clarifying regulations.”

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Volume XXV No. 16 – November 13, 2018

In this issue:

THE DARK REPORT ANALYZES a change of heart by the federal Centers for Medicare and Medicaid Services in the way it will collect data about the lab test prices paid by private health insurers. Good news? Not so fast. The changes CMS calls for won’t impact the Medicare fee schedule for two years. But on Jan. 1, 2019, CMS will make another painful 10% cut in what it pays for lab tests. Also in this issue is an exclusive look at how an innovative commercial lab company is developing ways to collaborate with physicians, health insurers, ACOs and others to improve patient care and lower the cost of care—and be paid for those contributions.

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Volume XXV No. 15 – October 22, 2018

In this issue:

WHO WILL BE NEXT? As federal prosecutors indicate in court there’s more to come in the ongoing Theranos investigation, that leaves the lab industry wondering who else might be charged with crimes. Reported only in THE DARK REPORT, this development means that any number of people could be targeted: former members of the Board of Directors, various consultants, even vendors. Meanwhile, Medicare has begun publicly posting prices charged by every pathologist in the country — so that every one of them can find out what their competition is up to. Will a new price war result? THE DARK REPORT offers a pricing “sweet spot” for readers to consider.

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Volume XXV No. 14 – October 1, 2018

In this issue:

TWO FEDERAL COURT RULINGS that will have immediate impact on the clinical lab industry are analyzed in detail in this issue. In a major setback for the ACLA lawsuit against the federal Department of Health and Human Services, a judge has ruled that the court lacks jurisdiction to take the case. THE DARK REPORT also offers an exclusive interview with the ACLA’s lead attorney to help readers understand the issues surrounding a possible appeal. Also exclusive to THE DARK REPORT is a report about a court ruling that two fairly common lab business practices are illegal inducements.

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Volume XXV No. 13 – September 10, 2018

In this issue:

CLINICAL LABORATORY MANAGERS will learn in this issue about two trends that are driving a movement to standardize laboratory operations across large regions: the integration of clinical care and the need for hospitals and health networks to improve patient outcomes continuously. THE DARK REPORT dives deeply into the details of an ambitious program along these lines in Michigan. Also, Theranos’ dying breath is detailed as the once-vaunted company finally goes under.

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Volume XXV No. 12 – August 20, 2018

In this issue:

THE DARK REPORT HAS UNCOVERED a previously unnoticed trend that turns common wisdom on Wall Street upside down: Hospitals and health systems may be taking back control of their their laboratory outreach programs instead of selling them, and committing major resources to their inpatient labs instead of outsourcing their management. TDR is the first to analyze this trend in three separate articles. Also, for both anatomical and clinical pathology, value-based payment is coming, creating an opening for pathologists who move quickly.

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Volume XXV No. 11 – July 30, 2018

In this issue:

THE DARK REPORT DEMONSTRATES that CMS is once again seemingly ignoring Congress’ intent with the Protecting Access to Medicare Act (PAMA) by leaving out hospital labs and outreach laboratories from price reporting. What will the outcome be this time around? Also, only TDR has detected a potential opportunity in managed care contracting for regional and outreach labs that can demonstrate how they add value to patient care.

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Volume XXV No. 10 – July 9, 2018

In this issue:

A CRISIS IN IRELAND has put two American laboratories in the crosshairs of potentially disastrous news reports, which, as THE DARK REPORT demonstrates, can quickly undermine the credibility – and profitability – of any lab. Also, THE DARK REPORT is first in the industry to call attention to new developments in the lab testing marketplace that have the potential to influence all clinical labs and pathology groups – in this case, the decision by two innovative health networks to make genetic tests available to their patients at primary care clinics.

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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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