R. Lewis Dark

Articles by R. Lewis Dark

Where Is the FDA When Labs Need It Most?

From the Volume XXVII No. 9 – June 22, 2020 Issue

LET’S START WITH AN ESSENTIAL FACT: in the management of almost every outbreak of a novel infectious disease, clinical laboratory tests will be essential in diagnosis of the disease, in monitoring the progress of an infected patient, and in determining if, once cured, a patient has immunity to tha…

Where Does COVID-19 Take Clinical Labs Next?

From the Volume XXVII No. 8 – June 1, 2020 Issue

It is easy to say that the current COVID-19 pandemic is a global event without precedent in human history. After all, what other event has caused airline travel to drop by 95%, ended all professional and amateur sports events worldwide, shuttered Broadway theaters and movie cinemas, closed all no…

Helping Labs with Cash Flow, COVID-19 Response

From the Volume XXVII No. 7 – May 11, 2020 Issue

ROUTINE SPECIMEN VOLUME REMAINS DOWN by 50% or more for clinical laboratories and anatomic pathology groups in the United States because of the pandemic. Through the end of last week, The Dark Report estimates that labs in the U.S. have lost almost $7 billion since the first week of March…

Clinical Labs Step Up, But Serious Problems Are Ahead

From the Volume XXVII No. 6 – April 20, 2020 Issue

ACROSS THE UNITED STATES, CLINICAL LABORATORIES ARE LIVING a good news/bad news story. The good news is that the essential role every lab plays in enabling fast, accurate diagnoses is now at the top of the news cycle. Daily, citizens of this country hear from the President and health officials th…

Lab at the Epicenter of NY’s Coronavirus Pandemic

From the Volume XXVII No. 5 – March 30, 2020 Issue

TODAY, THE NOVEL CORONAVIRUS PANDEMIC DOMINATES the daily activities of every clinical laboratory in the United States. The emergence of COVID-19 has triggered unprecedented actions by governments in different nations throughout the world. Within this country, all 50 states reported SARS-CoV-2 i…

Be Careful Payers, You May Get What You Wish For!

From the Volume XXVII No. 4 – March 9, 2020 Issue

Few clinical laboratory executives and pathologists would disagree with the assertion that both government and private payers would like to see the prices they pay for medical laboratory testing and the amount of money they spend reimbursing labs to stay flat or shrink from one year to the next. C…

Northwell and Memorial Health: A Tale of Two Labs

From the Volume XXVII No. 3 – February 17, 2020 Issue

Something very unusual happened in this issue of The Dark Report. We analyzed the entirely opposite fates of two clinical laboratories owned by different healthcare systems. With apologies to author Charles Dickens and his opening sentence in his novel, a Tale of Two Cities, it c…

Any Hope for Relief from PAMA Medicare Price Cuts?

From the Volume XXVII No. 2 – January 27, 2020 Issue

It is a notable and rare success for the clinical laboratory profession to convince the House and Senate to pass a law that is favorable to the interests of patients and the clinical laboratories that serve them. Yet that is what happened when Congress passed the Laboratory Access for Beneficiarie…

Is Health Price Transparency at Its Tipping Point?

From the Volume XXVI No. 17 – December 16, 2019 Issue

Is it a coincidence that a number of uninsured consumers filed separate lawsuits in federal courts against Laboratory Corporation of America and Quest Diagnostics—alleging, in both cases, that they were overcharged for clinical…

Labs Face New Challenges in New Year, New Decade

From the Volume XXVII No. 1 – January 6, 2020 Issue

TYPICALLY, PEOPLE CELEBRATE THE ARRIVAL OF A NEW YEAR and a new decade with optimism. That should be just as true for clinical lab managers and pathologists. After all, medical laboratory testing is fundamental to how physicians diagnose disease, select the most appropriate therapies, and monitor the…

Volume XXVII No. 9 – June 22, 2020

THE NEWS ON THE SEROLOGICAL TEST FRONT is discouraging, even bleak, as THE DARK REPORT analyzes the outcome of the FDA’s own review of 11 tests previously listed as marketable. Only three tests passed the review, and yet a quality control expert consulted by THE DARK REPORT has dim views of the FDA’s testing operation, leading to even more doubts. Also, health insurers are scraping away at mandated COVID-19 test reimbursements, leaving lab revenues once again at their mercy.

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