The Dark Report Archives

What if Congress Chooses to Pass an LDT-Specific Law?

CONGRESS HAS YET TO SPEAK SPECIFICALLY ON THE ISSUE of regulating laboratory developed tests (LDTs). Influential advocates on both sides of this issue have lobbied lawmakers on this issue for a decade. Given the stakes involved in the specifics of how laboratory developed tests are regulated, it is reasonable to assume that representatives and senators […]

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How Private Health Insurers May Respond to FDA LDT Regulation

Managed Care Contracts / Virchow

EDITOR’S NOTE: Our column, Virchow, is written by anonymous insiders working within the managed care world. The column aims to help clients of The Dark Report better understand the decisions, policies, and actions of payers as they manage their laboratory networks, establish coverage guidelines, process lab test claims, and audit labs. HOW MIGHT PRIVATE HEATLH

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June 10, 2024, Intelligence: Late-Breaking Lab News

Late Breaking Lab News / Robert Michel

Once a high-flier lab test manufacturer with a market valuation of $2 billion, Cue Health of San Diego filed for Chapter 7 bankruptcy on May 28. Analysts now say the company is valued at about $15 million. Founded in 2010, Cue Health was developing a test system that consumers could use at home. Its components

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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.

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Significant Developments Are Shaping Lab Market

Clinical Laboratory Trends / Robert Michel

CEO SUMMARY: With 140 speakers and 1,000+ attendees, this year’s Executive War College again provided a comprehensive picture of the specific forces reshaping the U.S. market for lab testing services. Presented here is a smorgasbord of information and innovation shared by different speakers that describe and validate different developments that affect the clinical service mix

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FDA Hosts Webinar to Explain Key Issues with Final LDT Rule

Laboratory Compliance / Robert Michel

ON APRIL 29. THE US FOOD AND DRUG ADMINISTRATION (FDA) announced its final rule on oversight of laboratory developed tests (LDTs). Most lab leaders oppose FDA jurisdiction over LDTs. Now that the rule is finalized, many labs want to know how it will be implemented. With that in mind, the agency presented a webinar

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New CISA Draft Rule Mandates Rapid Reporting of Cyberattacks

Laboratory Compliance / Robert Michel

CEO SUMMARY: There is another federal rule that will require compliance by clinical labs. An agency of U.S. Dept. of Homeland Security published a draft rule on April 4 that requires certain organizations—including hospitals, clinical labs, and pathology groups—to report, within 72 hours, any cyberattack and the payment of any ransom payments associated with a

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Lab’s Innovation Center Encourages Staff Ideas

Laboratory Management / Robert Michel

CEO SUMMARY: At a time when health plans consider lab testing a commodity, the team at Sonora Quest Laboratories deliberately set out to encourage ideas and innovation from its staff by creating the “Innovation Center of Excellence.” One innovation involves helping health plans and physicians close care gaps of their patients. CLINICAL LABORATORIES THAT SEEK

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May 20, 2024, Intelligence: Late-Breaking Lab News

Late Breaking Lab News / Robert Michel

Last month, members of a class action lawsuit against Theranos and other defendants received settlement checks. Members of the class included TDR’s Editor-in-Chief, Robert Michel, and his wife, Deborah. On behalf of The Dark Report, the Michels had investigated the actual laboratory testing practices of Theranos by undergoing clinical laboratory testing on themselves. Robert’s check

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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

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