July 2023

Cyberattack Victims Sue Enzo Biochem and Labcorp

CEO SUMMARY: It’s the latest reminder that clinical laboratories and anatomic pathology groups are at risk for two threats. One threat is a cyberattack that shuts down a lab’s IT system while stealing patient data. The other threat involves lawsuits against the same lab by patients unhappy that their protected health information was stolen by […]

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FDA Expected to Publish Proposed LDT Rule in August

In Vitro Diagnostics, Lab Risk & Compliance, Laboratory Compliance / Scott Wallask

CEO SUMMARY: Congressional lawmakers and the federal Food and Drug Administration are again eyeing changes that would bring greater oversight to laboratory-developed tests (LDTs). Leaders at clinical laboratories and pathology groups should monitor these proposals, both of which could have long-term ramifications for labs that use LDTs. Action to increase regulatory oversight of laboratory-developed tests (LDTs)

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HCCI Reports Higher Prices for Hospital Outreach Tests

Clinical Laboratory Trends, Lab Intelligence, Lab Marketplace, Laboratory Management / Robert Michel

CEO SUMMARY: It’s another shot across the bows to hospital and health systems that use inpatient test prices when billing health insurers for outpatient/outreach lab tests. In its report, the Health Care Cost Institute documents how these hospital lab outreach programs price their tests from three to five times higher than independent labs and POLs.

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Dartmouth Health Lab Recruits and Trains More CLSs

Clinical Laboratory Trends, Laboratory Management, People / Scott Wallask

CEO SUMMARY: Keeping clinical laboratories fully staffed may be the single biggest issue confronting labs today. In New Hampshire, the lab team at Dartmouth Health crafted an innovative program that pays students as they pursue their clinical laboratory scientist certification. In return, these students agree to a multi-year commitment to work at the Dartmouth Lab.

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Technical Assessment Challenges for Z-Code Applications

Clinical Laboratory Trends, Genetic Testing, Lab Intelligence, Laboratory Billing, Managed Care Contracts, Molecular Diagnostics / Scott Wallask

CEO SUMMARY: Effective on Aug. 1, UnitedHealthcare will require Z-code submissions for many genetic tests. During a recent webinar, experts tackled a topic that may prove troublesome for labs seeking Z-codes: technical assessments. Key advice is to provide specific data about clinical validity and clinical utility of a novel genetic test. UnitedHealthcare’s (UHC) new requirement that as

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UnitedHealthcare’s Z-code Policy Starts on Aug. 1

Clinical Laboratory Trends, Genetic Testing, Lab Intelligence, Laboratory Billing, Managed Care Contracts, Molecular Diagnostics / Robert Michel

CEO SUMMARY: UnitedHealthcare’s (UHC) response to the ever-growing number of unique genetic tests and the continuing growth in the volume of those claims is a new policy. Effective Aug. 1, UHC will require a Z-code with genetic test claims. This requirement means labs serving UHC beneficiaries need to obtain a Z-code for their genetic tests.

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Stressful Weeks Ahead for Labs Thanks to Z-codes

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

We are not alone in recognizing that UnitedHealthcare’s (UHC) upcoming mandate for Z-code use in genetic test claims has the potential to be disruptive to many clinical laboratories. Evidence of this widespread concern was provided on June 29. That’s the day that The Dark Report hosted a webinar titled, “Essential Guide to Obtaining Z-codes for Molecular and Genetic Tests.” Nearly

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