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Bloomberg Law
Ruling Limits Lab Onus on Medical Necessity
CEO SUMMARY: A federal appeals court ruling has established a legal “safe harbor” for clinical laboratories, shifting the burden of proof in False Claims Act cases. By allowing labs to generally rely on physician orders as evidence of medical necessity, the decision pr…
Owens & Minor Sues Anthem BCBS of Virginia
CEO SUMMARY: For years, clinical laboratories and pathology groups have expressed frustration with the lack of transparency by health plans in how they handle claims, set prices, and establish coverage guidelines. Now, because of recent federal laws and rules concerning health data transp…
Lab News Briefs
Siemens to Explore Sale of Its IVD Diagnostics Unit Siemens Healthineers, Erlangen, Germany, is reportedly looking into options for sale of its in vitro diagnostics (IVD) segment. The company’s “review co…
CURRENT ISSUE
Volume XXXIII, No. 10 – August 2026
In the August 2026 briefing, The Dark Report explains the relevance behind CMS potentially changing how it pays for “software as a medical service”. Other topics include a look into how health system executives view clinical labs, possible CLIA updates, and a 30/60/90-day approach to reducing reliance on traveling medical lab techs.
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