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Bruce Quinn MD PhD
CMS Proposal Could Redefine Medicare Payment for Software-Based Lab Testing
CEO SUMMARY: The proposed 2027 OPPS rule would move certain algorithm-driven analyses off the Clinical Laboratory Fee Schedule, potentially creating a new reimbursement framework for AI-enabled diagnostics. For clinical laboratories…
Using AI to Predict Outcomes in FDA LDT Lawsuits
Given the popular sentiment that artificial intelligence (A…
ACLA Files Court Challenge to FDA’s Final LDT Rule
CEO SUMMARY: Discussing the FDA’s final LDT rule, one pathologist tracking this matter wrote, “In many ways, the FDA’s plan [final LDT rule] is like the guy who gets three wishes from a genie, and he asks for unlimited wishes.” ACLA and HealthTrackRx are challenging the FDA’s …
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.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
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