Reliable Business Intelligence News About Clinical Laboratories, Pathology Groups, & Laboratory
Diagnostics Since 1995
The most complete archive of clinical and pathology lab industry news available, including issues from 1997 to the present.
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.
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.
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.
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.
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.
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.
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.
A pathology lab company in New Jersey has sued UnitedHealthcare, seeking payment for 46,400 molecular COVID-19 test claims that are unpaid, representing about $20 million in reimbursement. Also, Labcorp is successfully using AI in its lab operations to improve work processes and gain real-time insights from vast amounts of data.
Major changes are coming to the clinical lab marketplace, as large retail chains such as WalMart and CVS are establishing primary care facilities in-store. The Dark Report examines this trend in detail. Also, MedPAC has reported that it has found a more efficient, lab-friendly way to report payment price data, which could relieve labs of some of the onerous burden of reporting.
The Dark Report is going on record on two trends that will impact clinical labs and pathology groups right in their wallets. The first trend is the potential for the COVID-19 pandemic to fade out, leaving labs without a large source of revenue. The second is the rise of ransomware attacks on healthcare providers, including labs. Details on both trends are included in this issue.
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Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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