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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 XXV No. 9 – June 18, 2018

In this issue:

THE DARK REPORT sums up a tale of two fraudsters: Two counts of conspiracy, nine counts of wire fraud, the possibility of a lifetime in prison and $2.75M in fines each for Theranos’ Elizabeth Holmes and Ramesh “Sunny” Balwani. What does it all mean for tech startups – and clinical labs? Also, this issue delivers specific strategies that lab outreach directors can use to overcome current challenges and protect revenue, increase market share, and contribute to better patient care.

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Volume XXV No. 8 – May 29, 2018

In this issue:

THE DARK REPORT HAS DISCOVERED an intriguing but quiet trend in recent months: Lab companies are suddenly snatching up struggling rural hospitals to take advantage of their higher payment rates in what is called “pass-through billing,” a process that can and has strayed over the line into illegal territory. Interestingly, the businessman involved in one such recent transaction insists he “ran away as fast as possible” from an earlier company that was engaged in some sketchy billing schemes. Also in this issue, John Carreyrou of The Wall Street Journal describes his shocking experiences as he dug into, and later exposed, the now-infamous Theranos pyramid scheme.

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Volume XXV No. 7 – May 7, 2018

In this issue:

THE FUTURE OF THE LAB INDUSTRY was outlined in detail at the most recent Executive War College: Despite the challenges ahead, there are also tantalizing opportunities – but enterprising labs must pursue them vigorously. This intriguing finding is supported by a Cleveland Clinic test utilization management project also reported in this issue. In an exclusive analysis, THE DARK REPORT shows how the lab’s seven-year effort has prevented 160,072 tests and saved more than $5 million, while also improving quality and patient safety, and enhancing patient care and experience.

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Volume XXV No. 6 – April 16, 2018

In this issue:

THE DARK REPORT digs into the shocking path lab deficiencies found at Wake Forest Baptist Medical Center and discovers that labs with a single individual with critical compliance, training and oversight responsibilities could leave them in the same dangerous position. Also, analysis in this issue helps lab executives understand the issues in the PAMA lawsuit against HHS to better prepare them to educate their elected officials.

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Volume XXV No. 5 – March 26, 2018

In this issue:

HERE’S A FIRST LOOK at an important new trend: At first, it probably will have the greatest impact on anatomic pathology groups that perform cancer tests. But even clinical labs will find themselves dealing with new factors in the lab testing marketplace—particularly the ability to access or license valuable assays that incorporate the latest diagnostic technologies. Also in this issue are the latest developments in the tale of a lab company that made an early splash in drugs-of-abuse and pain management testing almost two decades ago, but is now going out of business, in part due to lingering allegations of abusive sales and billing practices.

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Volume XXV No. 4 – March 5, 2018

In this issue:

THE DARK REPORT WAS THE FIRST to draw attention to the increasingly popular “HOPD” billing scheme last November. Now it digs deeply into the details of new case that offers confirmation that insurers are resisting such schemes, as Anthem is poised to sue a tiny California hospital if it does not recover $13.5 million in a timely fashion. Also, TDR gives an exclusive analysis of documents in the PAMA lawsuit filed against CMS — including the revelation that CMS appears to have deliberately calculated how much Medicare could save by ignoring certain data, instead of basing the new fees on all the data requested by Congress.

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Volume XXV No. 3 – February 12, 2018

In this issue:

AN EXCLUSIVE ANALYSIS of the HDL-BlueWave fraud trial has several lessons for laboratorians: There’s new personal exposure that individuals may face from the federal government, a jury trial will not necessarily save wrongdoers, and blaming bad legal advice is a losing strategy if you’re thinking of breaking the rules. And in a related issue, experts in lab compliance predict that clinical labs and anatomic pathology groups must anticipate tougher enforcement of federal and state laws this year, starting with the rising use of third-party marketing agreements.

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Volume XXV No. 2 – January 22, 2018

In this issue:

AFTER A YEAR-LONG INVESTIGATION, THE DARK REPORT has put together evidence of an almost decade-long string of legal proceedings involving the healthcare businesses organized by some of the defendants in one of last year’s big fraud lawsuits. One year ago, UnitedHealth made national news when it filed a $100M lawsuit against Next Health and other defendants in Dallas. In the suit, UHC says the defendants submitted lab test claims totaling $400M between 2011 and 2016, and that it made payments of $101.5M to the defendant companies. Now TDR explains the serial nature of other lawsuits, federal indictments, and whistleblower cases involving some of these same defendants over the years.

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Volume XXV No. 1 – January 2, 2018

In this issue:

WHAT ARE THE ODDS for or against ACLA’s lawsuit against the Department of Health and Human Services? THE DARK REPORT has exclusive insight from two experienced lab industry attorneys to help lab managers better understand the likely paths that this litigation may take, and know how long it may take to come to a conclusion. Also, TDR is the first to alert readers that UnitedHealthcare is expanding the range of tests that will require pre-notification or prior-authorization in its controversial laboratory benefit management program in Florida.

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Volume XXIV No. 17 – December 11, 2017

In this issue:

AT THE LAST MINUTE, the American Clinical Laboratory Association has filed suit to block implementation of the looming CLFS price cuts called for by Jan. 1, 2018 — cuts that are expected to be the single most financially-disruptive event in the clinical lab industry in two decades. THE DARK REPORT offers first analysis of this late-breaking story. Also, this issue includes a special look at “Top 10 Lab Stories of 2017” that are related to the impending price cuts.

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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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