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

Volume XXXI, No. 7 - May 20, 2024

Behind-the-Scenes Audits Often Hide Cause of Test Claim Denials

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 man­ age their laboratory networks, establish coverage guidelines, process lab test claims, and audit labs. PRIVATE PAYER AUDITS …

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New CISA Proposed Rule Mandates Rapid Reporting of Cyberattacks

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 cyberattack. The …

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Why Ransomware Attacks Are a Threat to Your Lab

  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

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

  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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Labcorp, Quest Issue Q1 Earnings, Offer Comments on FDA’s LDT Rule

  BOTH LABCORP, BURLINGTON, N.C., AND QUEST DIAGNOSTICS, SECAUCUS, N.J., reported strong financial performance during the first quarter (Q1) of 2024. Base business—diagnostics excluding COVID-19 testing—jumped about 6% during Q1 as compared to base business in Q1 2023. Here is an overview of their financial results as well as key Q1 accomplishments. LABCORP: Grows Q1 …

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New CISA Draft Rule Mandates Rapid Reporting of Cyberattacks

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

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

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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