In this issue:

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In this issue:

This issue includes the annual Top 10 Lab Stories of the year, this year ranging from COVID-19 to ransomware attacks on labs to the Theranos trial. These stories are useful to use in strategic planning by lab directors and pathologists. Also in this issue, there’s a reprieve on PAMA fee cuts as Congress postpones the 2021 cuts for a year.

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In this issue:

Two distinctly different bills have surfaced in Congress, each with the potential to have substantial impact on how laboratory-developed tests (LDTs) are regulated by agencies of the federal government. Also, an attorney with decades of experience in advising clinical labs on CLIA matters analyzes the lessons to be learned for lab directors in the Elizabeth Holmes trial.

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There are many important lessons for the clinical lab industry to learn from the federal fraud trial of Elizabeth Holmes, and The Dark Report studies them in depth. Also, a live Executive War College highlighted clinical laboratory and pathology trends for the coming months and years.

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The former Theranos lab director, pathologist Adam Rosendorff MD, has been in the news, as Elizabeth Holmes’ defense demonstrates the risks associated with lab oversight. Also, Walgreens has announced it will build 1,000 primary care clinics by 2027, showing how the traditional model of primary care is changing.

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This issue highlights the young and upcoming IVD firms that are creating a new class of such companies, dedicated to point of care and near-patient technologies. Also, artificial intelligence has made its first breakthrough into clinical care in digital pathology.

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In this issue:

The Dark Report outlines the dangers to clinical labs and pathology groups posed by encryption attacks and their ransom demands, including steps an organization should take if attacked and how to prevent attacks. Also, a company developing image analysis software announced the acquisition of one of the nation’s largest independent anatomic pathology (AP) laboratories.

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Not only are health insurers looking back to find overpayments and funds paid erroneously, but payers also are requiring documentation for overpayments. If clinical labs and anatomic pathology groups do not appeal such claims quickly, they may be liable for any amount insurers deem to be overpayments.

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In this issue:

In the past 24 to 36 months, some labs have quietly begun using AI-powered applications that are being used to improve operational work processes, to streamline coding/billing/collections, and for analyzing digital pathology images. Also, genetic tests are growing in number and complexity, making it ever harder for labs to get paid.

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