Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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
MSSA Screening Program Cuts Infections in NICUs
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Penicillin Allergy Testing Underused, Could Lead to Cost Savings
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FDA Enabling New Point-of-Care Tests for Ebola Outbreak, Flu Season
From - Diagnostic Testing & Emerging Technologies
Several recent U.S. Food and Drug Administration (FDA) actions are bringing point-of-care (POC) infectious disease tests closer to…
Medicare Appeals: CMS Tries to Speed the Process & Unjam the Backlog
From - National Intelligence Report
On Oct. 2, CMS proposed revisions to rules for appealing adverse Medicare claim determinations (Proposed Rules). The goal is to speed the process that…
6 Steps to Data-Driven Transformation
By Nir Kaldero bio
We're now well into the Fourth Industrial Revolution. The First Industrial Revolution was about steam and railroads, the Second about electricity, and the…
Rural Hospital Lab Outreach or Fraudulent Overreach?
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One-Fourth of Myriad’s Variants of Unknown Significance Reclassified Over 10 Years
From - Diagnostic Testing & Emerging Technologies
Variant reclassification following hereditary cancer genetic testing is common, according to a study published by…
Reimbursement Trends: Part B Medicare Lab Payments Up Slightly in 2017
From - G2 Compliance Advisor
According to a new OIG report, Clinical Laboratory Fee Schedule payments for lab tests in…
FDA Watch: Changes to CBER Email Policy May Affect Your Lab
From - Laboratory Industry Report
Heads up to any lab that's subject to oversight by the CBER, i.e., the FDA agency responsible for regulating biological products for human use…
Kickbacks: OIG Okays Incentivizing MDs to Order More Early Screening Tests
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