FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
National Lab Reporter
Keeps You Up-to-Date on Federal & State Laws, Regulations, New Legislation, and Court Cases that Affect Your Diagnostic Lab or Pathology Practice
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Meeting the Needs of Laboratory Learners
The CDC’s OneLab training initiative offers free courses, events, resources, and networking opportunities for clinical lab professionals
Electronic Prior Authorization Bill Reintroduced in Congress
For clinical labs, the proposed law could bring more consistency to test ordering
LDTs: Top 10 New FDA Diagnostic Approvals of 2017
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CLIA: After 36 Years, CMS Gives Lab Accreditation a Good Hard Look
From - National Intelligence Report
If you've been in the clinical labs business for a while, you probably appreciate the wisdom behind this ancient Chinese curse. 2018 is shaping up to be a very…
Labs Figure Prominently in OIG’s Newest Top 10 Challenges List
From - National Intelligence Report
Although the OIG has its flaws, lack of transparency is not among them. Exhibit A: the agency's ongoing list of top 10 management and…
New Lawsuit Tests Limits of Medical Malpractice in Age of Precision Medicine
From - National Intelligence Report
One patient claims it is and wants $1.8 million in damages because she never got it…
Enforcement Trends: 5 Takeaways from OIG’s New Semiannual Report
From - National Intelligence Report
Veteran OIG semiannual report aficionados will find little in the most recent edition to distinguish it markedly from its predecessors. But while a new…
Cybersecurity: New Bill Would Make Lab Employees Criminally Liable for Concealing Data Breaches
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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Medicare Reimbursement: CMS Finalizes Controversial PAMA Fee Schedule
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FDA Watch: Agency to Allow DTC Marketing of Genetic Tests without Premarket Approval
From - National Intelligence Report
The FDA's longstanding policy of restricting direct-to-consumer (DTC) marketing of products without formal premarket approval is well known. But while it always applied to…
CMS Ignores Flawed Processes, Finalizes 2018 PAMA Pricing; Labs Need to Take Immediate Action to Offset Impending Lean Times
By Kyle Fetter bio
The final 2018 clinical laboratory fee schedule (CLFS) is out, and it is evident that the argument that the Centers for Medicare & Medicaid Services (CMS) PAMA process was…
