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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
Report Highlights Role Diagnostics Will Play in Food Allergy Safety
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Sequencing Not Ready for First-Line, Newborn Screening
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FDA Synthesizes Feedback on LDTs in New Discussion Paper
From - National Intelligence Report
Following up its decision not to issue final guidance in 2016 regarding oversight of laboratory developed tests (LDTs), the U.S. Food and Drug Administration released a…
First HIPAA Breach Notification Settlement Totals $475,000
From - G2 Compliance Advisor
Patient health information breaches—whether from hacking, glitches or just plain old carelessness…
Sequencing Following Ultrasound Improves Prenatal Diagnosis
From - Diagnostic Testing & Emerging Technologies
Nonsevere fetal malformations and structural abnormalities are relatively frequent findings of routine, prenatal ultrasounds. Yet, these findings provide…
FDA Approves Next-Gen Companion Diagnostic
From - Laboratory Industry Report
A notable FDA Section 510(k) approval was granted before the close of 2016 for Foundation Medicine's FoundationFocus CDxBRCA, a next-generation sequencing-based companion diagnostic test…
Update on Palmetto’s Molecular Dx Testing LCDs
From - Diagnostic Testing & Emerging Technologies
Advanced diagnostic tests are emerging faster than the clinicians can document their clinical utility. All of this creates an interesting dilemma for…
Diagnostics to Play Important Role in Food Allergy Safety
From - Diagnostic Testing & Emerging Technologies
Despite the commonly held belief that the food allergy prevalence is rising, food allergies remain poorly studied and…
OIG Updates Threshold for Nominal Value Gifts
From - National Intelligence Report
Just as the civil monetary penalties have gotten an update to adjust for inflation so too have the thresholds for…
OIG Targets Sleep Study Tests
From - G2 Compliance Advisor
If your lab performs sleep studies on Medicare patients, beware. It is now a high-priority target for federal fraud and…