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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Quest Diagnostics Has Published Enormous Lead Contamination Study
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CMS Bars Theranos’ California Lab from Medicare Program
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Transgenomic Tries to Jumpstart Business Model Again
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CMS’s Proposed Gapfill Prices for Molecular Tests Would Lead to Big Reimbursement Cuts
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LabCorp Develops Companion Diagnostic for Roche Cancer Drug
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New FDA Draft Guidance Addresses Companion Diagnostics
From - National Intelligence Report
The U.S. Food and Drug Administration (FDA) released another draft guidance document last week that addresses…
U.S. Colorectal Cancer Screening Capacity Exists, Although Actual Rates Remain Low
From - Diagnostic Testing & Emerging Technologies
The United States has the screening capacity to meet colorectal screening goals, but this capacity has so far not translated into increased screening rates, according to a…
Penalties for False Claims Aren’t the Only FCA Risk to Avoid
From - G2 Compliance Advisor
In the last two issues of Lab & Pathology Insider we highlighted new developments concerning the False Claims Act (FCA): the U.S. Supreme Court decision recognizing the…
Use of Cologuard Test Will Be Placed in 2017 HEDIS Guidelines
From - Laboratory Industry Report
Exact Sciences' molecular colorectal cancer test will be included in the National Committee for Quality Assurance's (NCQA) updated guidelines for screening for…
Lead Testing Under-Used; Geographic Variability in Elevated Levels Can Target Testing
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