Since 1995, Reliable Business Intelligence for Clinical Laboratories, Pathology Groups and Laboratory Diagnostics

Commentary and Opinion by R. Lewis Dark

Getting Test Claims Paid & Class Action Lawsuits

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

When you crack open this issue of The Dark Report, you will find it organized around two primary stories. One story introduces you to a new type of legal attack on healthcare providers—including clinical laboratories—by class action lawyers. The second story delivers to you a comprehensive look at which lab test claims are getting paid […]

To access this post, you must purchase The Dark Report.

Getting Test Claims Paid & Class Action Lawsuits Read More »

Federal Prosecution of Lab Test Fraud & Abuse

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

SOMETHING NEW AND DIFFERENT IS HAPPENING WITH THE ENFORCEMENT OF FRAUD AND ABUSE LAWS by the federal Department of Justice (DOJ). The number of cases being filed has increased over recent years. In turn, that means an increase in press releases announcing criminal convictions, guilty pleas, and civil settlements. This development has become apparent over

To access this post, you must purchase The Dark Report.

Federal Prosecution of Lab Test Fraud & Abuse Read More »

It is The Dark Report’s 30th Anniversary!

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

It was 30 years ago, in September 1995, when the first issue of The Dark Report was published and distributed to the clinical laboratory profession. For nearly one-third of a century, our editorial team has worked to bring you the most relevant news, market assessments, and case studies of lab innovations. Many of you have

To access this post, you must purchase The Dark Report.

It is The Dark Report’s 30th Anniversary! Read More »

Unpacking the Surprises in the FDA LDT Rule

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

THERE ARE NOW TWO LAWSUITS IN TWO DIFFERENT COURTS CHALLENGING THE Food and Drug Administration’s Authority to regulate laboratory developed tests (LDTs). The first was filed on May 29, 2024, by the American Clinical Laboratory Association (ACLA). The second was filed on Aug. 19, 2024, by the Association for Molecular Pathology (AMP). However these lawsuits

To access this post, you must purchase The Dark Report.

Unpacking the Surprises in the FDA LDT Rule Read More »

Watch Out Pathologists! They’re Coming for Histology!

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

For any lab that depends on revenue from its histology laboratory, this issue of The Dark Report has important intelligence about a serious threat to this existing business model. One of your biggest, best-financed competitors is preparing to make a foray into this market segment of lab testing. I direct you to the sidebar with

To access this post, you must purchase The Dark Report.

Watch Out Pathologists! They’re Coming for Histology! Read More »

What’s a Big Headwind for Labs? It’s the LDT Rule!

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

EXECUTIVES AT PUBLICLY-TRADED CORPORATIONS AND THE FINANCIAL ANALYSTS WHO COVER THESE COMPANIES like to use the term “headwinds” when describing problems preventing these companies from succeeding. It’s the polite euphemism that acknowledges real-world negatives without calling them by their real names, such as high customer turnover, shrinking market share, and poor economic times. I

To access this post, you must purchase The Dark Report.

What’s a Big Headwind for Labs? It’s the LDT Rule! Read More »

Is It Time for Clinical Labs to Embrace Consumers?

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

HEALTHCARE IN THIS COUNTRY HAS A WELL-DESERVED REPUTATION for being slow to incorporate new clinical knowledge, technologies, and management models into daily practice. Adoption of these innovations by hospitals, physicians, and clinical laboratories often lags behind other industries by several years. Seen in this context, today’s “new consumer” is one of those powerful developments that

To access this post, you must purchase The Dark Report.

Is It Time for Clinical Labs to Embrace Consumers? Read More »

LDT Rule Is Now a Fact! What Will Be Consequences?

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

TODAY, THE NEW RULE FOR REGULATION OF LABORATORY DEVELOPED TESTS (LDTs) issued by the federal Food and Drug Administration (FDA) is an accomplished fact. In taking this action, the FDA has created a regulatory scheme that is widely viewed as disruptive and counter-productive by pathologists and clinical lab executives involved in performing LDTs in support

To access this post, you must purchase The Dark Report.

LDT Rule Is Now a Fact! What Will Be Consequences? Read More »

Why Ransomware Attacks Are a Threat to Your Lab

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

Have you and your lab management team noticed the major shift in cybercrime that targets healthcare providers, including clinical laboratories and pathology groups? For years, cybercrime was primarily security breaches involving the theft of patients’ protected health information (PHI). This is no longer the case. Today, a growing proportion of cybercrime involves ransomware attacks.

To access this post, you must purchase The Dark Report.

Why Ransomware Attacks Are a Threat to Your Lab Read More »

Artificial Intelligence and Executive War College

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

By the time you read this our 29th annual Executive War College on Diagnostics, Laboratory, and Pathology Management conference will be underway in New Orleans. As noted in previous issues of The Dark Report, three topics will be of keen interest. First is the FDA proposed rule for laboratory developed tests (LDTs). Second is private

To access this post, you must purchase The Dark Report.

Artificial Intelligence and Executive War College Read More »

;