The Dark Report Archives

Change Health Cyberattack Breaches PHI Here at TDR!

CEO SUMMARY: It was Feb. 21 when cybercriminals attacked Change Healthcare’s claims processing systems. On April 22, UnitedHealth Group issued a statement that PHI for “a substantial proportion of people in America” was breached. We believe the PHI of our employees and The Dark Report itself was breached because fraudsters recently attempted to use employees’ […]

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Wisc. Diagnostic Lab’s Alternative Staff Solutions

Laboratory Management / Robert Michel

CEO SUMMARY: Even as clinical laboratories and pathology groups around the nation cope with a sustained shortage of qualified staff, the team at Wisconsin Medical Laboratories has successfully kept staffing at 96% of authorized levels. One effective strategy they use is to go into the community to educate recent college graduates and high school students

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UnitedHealth Group Faces DOJ Antitrust Probe

Laboratory Management / Robert Michel

CEO SUMMARY: Recent events have not been kind to UnitedHealth Group and its subsidiaries UnitedHealthcare and Optum. In February, just as UHG’s Change Healthcare division was hit with a major cyberattack that disrupted billions of dollars in medical claims, news leaked out that the federal Department of Justice was investigating the firm for antitrust violations.

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Congressional Subcommittee Hears Testimony on FDA LDT Rule

Laboratory Compliance / Robert Michel

DURING A MARCH 21 HEARING CONVENED by the U.S. House Energy and Commerce Subcommittee on Health, key members of Congress came under fire from representatives of clinical laboratory groups over the Food and Drug Administration’s (FDA’s) proposed rule to regulate laboratory developed tests (LDTs). The participants also disagreed over whether the Verifying Accurate, Leading-edge IVCT

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Payer Contracts with Labs: Getting the Contract Is Just the Start

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. IT IS COMMON FOR

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April 29, 2024, Intelligence: Late-Breaking Lab News

Late Breaking Lab News / Robert Michel

It may be that the genetic data cat is out of the bag already. Nonetheless, lawmakers in Delaware are considering a bill that—among other things—would prevent life insurance companies from buying or using genetic testing data if it was obtained from ancestry companies and not from medical records. Lawmakers and reporters recognize that Ancestry.com and

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Are Lab Leaders Ready for Artificial Intelligence?

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

WITH ASTONISHING SWIFTNESS, ARTIFICIAL INTELLIGENCE (AI) HAS BECOME PROBABLY THE SINGLE MOST IMPORTANT TECHNOLOGY discussed in corporate boardrooms and management meetings today. This is as true for clinical labs and pathology groups as it is for Fortune 100 corporations. Almost daily, there are headlines about the inroads AI is making into different aspects of business

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Lab Market Fragmenting, Creating New Opportunities

Laboratory Management / Robert Michel

CEO SUMMARY: Even as consolidation continues in the ownership of hospitals, health systems, office-based physicians, and clinical laboratories, there is a powerful trend of fragmentation quietly transforming the way providers—including clinical labs and pathology groups—serve patients and consumers who want specialized expertise and choice. Today’s market for clinical laboratory testing services is fragmenting at a pace

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FDA Issues Memo to Reclassify Many High Risk IVD Assays

Laboratory Compliance / Robert Michel

WAS IT AN EXPECTED FLOOD OF APPLICATIONS TO REVIEW laboratory developed tests (LDTs) that motivated the federal Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) to declare its intention “to initiate the reclassification process for most IVDs that are currently class III (high risk) into class II (moderate risk)” in a

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Walgreens to Close 60 VillageMD Locations

Clinical Laboratory Trends / Robert Michel

CEO SUMMARY: Following substantial losses in fiscal 2023, Walgreens is working to cut costs and reduce overhead. One casualty in this effort will be the closure of 60 of the 360 primary care clinics in retail pharmacy stores built by Walgreens in recent years. These actions demonstrate that putting primary care clinics into drugs stores

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