Four Federal Efforts to Monitor, Including RESULTS Act Progress
Other proposals aim to increase fraud enforcement, temper prior authorization, and modernize CLIA
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Laboratory Industry Report
Keeps You Up-to-Date on Lab Business and Competitive Strategy, Market Trends and Opportunities, and M&A and Investment Activity in Today’s Diagnostic Lab Industry
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Articles and Reports
FDA Watch: New RAPID Coverage Pathway Would Enable Some Lab Tests to Pursue Clearance and Medicare Coverage Simultaneously
FDA-CMS collaboration aims to accelerate Medicare coverage determinations of certain medical devices
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Dx Deals: Blackstone, TPG Take Hologic Private in $18.5 Billion Deal
Hologic has been on the vanguard of developing and distributing tests focusing on women’s health
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RCM Strategies to Explore for Genetic Testing Compliance
Expert Ashley Zarling details nuances for clinical lab directors and compliance teams
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Dx Deals: Abbott Closes Exact Sciences Acquisition, Takes Control of Cologuard Franchise
Biotech giant purchased the company for $21 billion, one of the largest deals in clinical lab history
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FDA Watch: MeMed and NG Biotech Receive FDA Breakthrough Device Designations for Rapid Infection Tests
In both cases, the diagnostic tests report results back within 15 minutes
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ADLM Calls on Feds to Regulate AI in the Clinical Lab Sector
But anti-regulatory stance taken by Trump administration could serve as a potential obstacle in the effort
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Dx Deals: Labcorp Buys Select Assets of Empire City Laboratories
The national lab giant swiftly merged Empire City’s operations into its own
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Recent MD Labs Ruling Has Implications for Test Requisitions and Commissions
A federal appeals court upheld the idea that clinical laboratories can rely on physician orders to justify medical necessity
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OIG Report on Lab Testing Should Prompt Compliance Review
Genetic testing now accounts for 43 percent of all Medicare Part B laboratory spending
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Overturning of Molecular Test Coverage Denials Varies Widely, According to UCSF Study
Research into independent medical review data in four states show payers’ internal policies affect rates of overturns
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Dx Deals: Fulgent Genetics Scores Two Laboratories in a Single Deal
It is acquiring Bako Diagnostics and StrataDx for a combined $55.5 million
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FDA Watch: Truvian Health Obtains 10 Additional FDA Clearances for TruVerus Platform
TruVerus is designed to perform a slew of clinical laboratory tests on as few as eight drops of blood
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