Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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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
Top of the News: ANDE Rapid DNA Platform First to Win FBI Approval
From - Laboratory Industry Report
"Great news! The FBI just called."
–Extremely rare phrase almost never uttered except sarcastically…
Report Finds Genetic Tests and Their Reimbursement Increasingly Complex
From - Diagnostic Testing & Emerging Technologies
The health care technology company Concert Genetics (formerly NextGxDx; Nashville, Tenn.) recently released its third edition of…
How PAMA’s Effect in 2018 Molecular Diagnostic Reimbursement Will Make Labs More Money
By Sean McSweeney bio
The year 2018 is slated to be much brighter for molecular diagnostic labs as PAMA fee schedules show a higher payment rate and amount for many cancer genomics and…
Tool: Respirator Fit Testing Checklist
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OIG Work Plan Monthly Review: June 2018
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FDA Opens Door to Direct-to-Consumer Marketing of Genetic Tests—But Just a Crack
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Genomic Tests: Two New Assays Win FDA Breakthrough Device Designation
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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Enforcement Trends: OIG Report Suggests that Urine Drug Testing Is Making Labs a Juicy Target Once Again
From - National Intelligence Report
The Office of Inspector General just published its Semiannual Report to Congress (covering Oct. 1, 2017 through March 31, 2018). Here are the key things labs and lab managers need to…
Blood Cultures for Cellulitis Often Needlessly Ordered
From - Diagnostic Testing & Emerging Technologies
Despite existing recommendations, blood culture is overused in patients with suspected, uncomplicated cellulitis, according to a research letter published…
