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

Commentary and Opinion by R. Lewis Dark

Innovations in Lab Testing Arriving at Light Speed

Commentary and Opinion by R. Lewis Dark, Laboratory Compliance / R. Lewis Dark

TODAY, IT’S A CHALLENGE TO STAY UP WITH ALL THE NEW THINGS arriving in the lab testing marketplace. Novel assays are launched weekly. That is equally true for next-generation automation and lab analyzers, with vendors regularly announcing something new to their menu of products. The pace of innovation involving information technology is moving even faster. […]

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Market Speaks to Pathologists: It’s About Data

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

ONE PRIMARY TREND IN THE U.S. HEALTHCARE SYSTEM over the past 20 years deals with how patient data is created and used. Ongoing advances in information technology and the Internet—now commonly called “the cloud”—have created capabilities for data sharing and data analysis today that were unimagined by experts only a few years ago. Most pathologists

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Labs: Why it Pays to Know Your Customers

Commentary and Opinion by R. Lewis Dark, Laboratory Compliance / R. Lewis Dark

WOULD IT SURPRISE YOU TO LEARN THAT THERE ARE DOCTORS WHO ARE SERIAL WHISTLEBLOWERS? Given the ongoing amount of fraud in healthcare—particularly involving genetic and clinical laboratory tests—there is opportunity for physicians in private practice to recognize arrangements that involve illegal inducements and the ordering of medically unnecessary procedures. This realization came about as the

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Using AI to Predict Outcomes in FDA LDT Lawsuits

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

Given the popular sentiment that artificial intelligence (AI) is now working its way into all sorts of lab analyzers, automation, and information systems, no one should be surprised that an astute pathologist would find it interesting to use artificial intelligence (AI) to analyze the legal briefs in the two ongoing federal court cases challenging the

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Lawsuits Challenge Business Practices of Health Plans

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

IT MAY BE THAT SEVERAL RECENT FEDERAL LAWS AND RULES ON TRANSPARENCY IN HEALTHCARE are allowing aggrieved parties to pull back the curtain on unsavory practices at certain health insurance companies. Both self-insured employers and the employees of these companies are filing lawsuits claiming that payers are violating these laws. The Dark Report is the

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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

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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

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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

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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

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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

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