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.
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.
As Millennials become set to dominate the workforce and national life, The Dark Report analyzes their preferences as consumers and how those preferences will change healthcare. Also in this issue is a report on how a federal court affirms that paying sales contractors commissions violates the Anti-Kickback Statute.
The Dark Report notes that Amazon is now selling at-home COVID-19 test kits as yet another move by the retail giant into the healthcare space. Also in this issue is a report on how IVD firms have benefitted from the pandemic in many ways, not the least of which is financial.
THERE’S POSITIVE NEWS FOR LABS on several fronts. For one, the daily number of routine test specimens is near pre-pandemic levels and certain sectors of lab testing—particularly genetic tests and some high-cost assays—are showing substantial growth this year, compared to 2019. Also, the Stark Law and AKS have been revised to make it easier for labs to comply.
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Volume XXXII, No. 13 – September 15, 2025
The Dark Report examines a new bill that would reform PAMA and avoid reimbursement rate cuts scheduled for January 2026. Clinical laboratory leaders are urged to make their voices heard in Congress. Also, an expert describes how labs can fix pre-analytical errors and avoid disaster.
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