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.
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.
AN ONCOLOGY RESEARCH LAB demonstrates the usefulness of SARS-CoV-2 variant sequencing as hospitals, health systems, schools, and municipalities are interested in identifying infection sources and tracking the virus’ spread. Also, the conviction for manslaughter and mail fraud of a VA pathologist is a lesson for all anatomic pathology groups to heed, a lawyer explains.
VARIANT SEQUENCING FOR COVID-19 is the next big opportunity for clinical labs and pathology groups. It is currently being undertaken by large labs and academic medical centers, but local labs could be next. Also, The Dark Report reports on a highly successful collaboration on a COVID test between a university and a commercial company.
THE DARK REPORT HAS DiSCOVERED that 3 major health systems with 372 hospitals have switched to a different CLIA accreditation organization over the past 18 months. All the details are examined here, including reasons why a health system might make such a switch. Also in this issue is an exclusive newsmaker interview with the CEO of a new company that is challenging the 70-year-standard Coulter Principle technology in hematology.
There are several surprises in The Dark Report’s annual list of the Top 10 Lab Stories for 2020. Despite the SARS-CoV-2 pandemic dominating every aspect of clinical care, social life, and economic activities since March, at least one major health insurer pushed ahead with two major policies governing how labs can submit claims. In another big story, for the first time in decades, the federal Anti-Kickback Statute and the Stark Law were revised with new final rules. Also, Medicare lab test spending increased in 2019 despite PAMA cuts.
IN A SURPRISING AND INSPIRING story, a Maine lab executive shares how his lab began preparations for COVID-19 in December 2019. Another lab’s story of pivoting from pathology testing to COVID-19 testing is equally instructional. And in other news, one CPT code has been used so often and for such high payments, it’s earned the title “fraudomatic” from an expert observer.
UNWELCOME CHANGES to how labs do business are forcing labs to cope with high demand for COVID-19 testing while dealing with government and private payers interfering with normal operating procedures. Medicare has new requirements and payment rates for COVID-19 tests. Also reported here are UnitedHealthcare’s new Laboratory Test Registry Protocol, and California’s new COVID-19 testing laboratory that is diverting lab instruments, supplies, and test kits away from hospital and independent labs in the state.
INDUSTRY LEADERS SHARE THEIR CONCERNS over CMS’ planned cuts to COVID-19 test payments and discuss their proposed strategies for COVID testing. Also, a pathology group reports lessons learned the hard way when it opened a brand-new clinical lab in the midst of the worst of the pandemic.
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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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