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
Exome Sequencing Improves Diagnosis of Fetal Structural Anomalies
From - Diagnostic Testing & Emerging Technologies
Prenatal diagnostics have evolved from conventional cytogenetic analysis to increasingly chromosomal microarray analysis, within the last…
HHS Proposes Eliminating Drug Rebates to Cut Medicare Prescription Costs
From - National Intelligence Report
On Jan. 31, Department of Health and Human Services Secretary Alex Azar floated a proposed rule to…
Communication: Managing Amid Change
From - Laboratory Industry Report
Greek philosopher Heraclitus said the only thing constant is change. Although he never managed a diagnostic laboratory, his words…
Pain Clinic Co-Owner Pleads Guilty to Drug Testing Kickback Charges
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FDA Watch: Latest Plan to Simplify 510(k) Premarket Review of New Tests
From - National Intelligence Report
While everybody agrees that the FDA 510(k) premarket review pathway is antiquated and in desperate need of an overhaul…
Donor-Derived, Cell-Free DNA May Predict Lung Transplant Rejection
From - Diagnostic Testing & Emerging Technologies
Elevated donor-derived, cell-free DNA (ddcfDNA) in the 3 months post-lung transplant can identify clinically silent allograft injury and…
The Dx Pipeline: A Roundup of the Month’s Key New Product Launches
From - Laboratory Industry Report
After a slow January, new product development picked up steam in February. Here's a rundown of the key new launches…
Owner of MD Practices Settles Fraud Charges for $3.07 Million
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DX Earnings Report: Lab Companies Finish 2018 Strong but Growth Slows for Established Firms
From - Laboratory Industry Report
The diagnostics industry capped a robust 2018 with most companies posting strong fourth quarter results. Of course…
Enforcement Trends: Record Breaking Year for HIPAA Fines
From - National Intelligence Report
The federal Office for Civil Rights (OCR) reports that 2018 was a record year for HIPAA enforcement, with 10 settlements and one judgment bringing in…