Lab Risk & Compliance

CLIA on Path to Recognize Lab Data As a Specimen

CEO SUMMARY: Discussions within the federal Clinical Laboratory Improvement Advisory Committee (CLIAC) are focusing on digital diagnostic data and clinical laboratory testing conducted remotely. CLIAC recommendations about these important topics may eventually be part of updates to …

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Eight Macro Trends for Clinical Labs in 2023

CEO SUMMARY: Laboratory administrators and pathologists will want to carefully study eight important trends that will guide their business strategies in 2023. Many of these macro trends center on financial and operational difficulties and ways to steer around these obstacles. Anothe…

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2022’s Top 10 Lab Stories Confirm Challenging Times

CEO SUMMARY: There are valuable insights to be gleaned from The Dark Report’s “Top 10 Lab Industry Stories for 2022.” Several of this year’s story picks involve external forces reshaping healthcare in the United States in profound ways. Other story picks for 2022 illustrate …

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Holmes, Balwani Get Lengthy Prison Terms for Theranos Fraud

SENTENCING OF ELIZABETH HOLMES AND RAMESH “SUNNY” BALWANI in federal court caps the strange, yet captivating, saga of Theranos and its flawed blood testing technology. For laboratory professionals, the four years of legal wranglings that surrounded the Theranos fraud case may be remembered …

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VALID and SALSA Acts Still Pending in Congress

CEO SUMMARY: Both the pending VALID Act and SALSA Act continue to push ahead as 2022 comes to an end. Meanwhile, a new bill centered on the Physician Fee Schedule may protect pathologist payments. These three different proposals share something in common:…

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Lab Allegedly Billed Medicare for Tests It Did Not Perform

Following up on a Sept. 19 intelligence briefing, an attorney told The Dark Report that a federal case alleging genetic test fraud showed hallmarks of pass-through billing.  As such, it raises questions about whether reference l…

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Ravgen Gets $272.5 Million Verdict against Labcorp

CEO SUMMARY: In September, a jury returned a $272.5 million verdict against Labcorp, representing royalties owed to biotech company Ravgen for infringement of its diagnostic genetic test patent. Soon after, Quest Diagnostics settled a similar lawsuit with Ravgen before its tri…

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Ex-Theranos CEO Elizabeth Holmes Awaits Ruling on New Trial Request

Keeping with the unexpected and odd circumstances sur­rounding Theranos, a federal judge heard arguments on Oct. 17 about whether convicted company founder Elizabeth Holmes’ should get a new trial. That hearing stemmed from the gov­ernment’s star witness in Holmes’ 2021 tr…

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Labs Must Audit Their Cybersecurity Measures

CEO SUMMARY: While clinical laboratory managers and pathologists are aware of the risks of a data breach, they often assume that related protection measures are working as needed. That is a mistake. With the cost of healthcare data breaches on the rise, it is vitally important for l…

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Attorney Advises Labs to Track Genetic Test LCDs

CEO SUMMARY: Skyrocketing numbers of genetic test referrals and telehealth claims since 2016 are getting the full attention of both federal prosecutors and auditors from Medicare and private health insurers. The DOJ has filed criminal cases against a growing number of telehealth pro…

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