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
Compliance Planning: OIG Switches from Semi-Annual to Monthly Work Plan Updates
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Companion Diagnostics Driving New Model for Pharma-Dx Partnerships
US oncology patients are missing out on targeted therapies due to a combination of testing "quality gaps" and slow test diffusion
FDA Approves First Companion Diagnostic Panel
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Lab-Pharmacy Partnerships Expand Retail Lab Testing Trend
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Labs to CMS: Push Back PAMA & Add Hospital Labs to CLFS Mix
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FDA Watch: Another First as Agency Approves NGS Oncology Companion Dx for Multiple Therapies
From - Laboratory Industry Report
The FDA made a stir in May by approving a cancer drug (Keytruda (pembrolizumab) PD-1/PD-L1 inhibitor from Merck) administered on the basis of a…
Sequencing-Based Screening Needed for Therapeutic Stem Cells
From - Diagnostic Testing & Emerging Technologies
One of the potential therapeutic advantages of stem cells is that they can regenerate. But, a new study, published May 11 in Nature, suggests that the longer…
Theranos and Walgreens Bury the Hatchet—For Now
From - G2 Compliance Advisor
It all looked so promising back in 2015. Privately-held Theranos was poised to usher in a new era of diagnostics with its revolutionary fingerprick technology for…
Employment Law Update for August 2017
By Mike O'Brien bio
Here is my periodic update prepared for interested HR professionals trying to deal with the complex American employment laws…
Help Your Lab Brace for Key Medicare Outpatient Reimbursement Changes
From - G2 Compliance Advisor
With the 2018 Clinical Laboratory Fee Schedule (CLFS) still in the works, CMS proposed changes to the Hospital Outpatient Prospective Payment System (HOPPS) rules on…
