Clinical Lab Management
News on issues related to managing clinical laboratories.
Local Cancer Genomic Profiling Options Grow, Though Central Labs Will Likely Keep Major Role
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As economic and practical challenges of next-gen sequencing have eased in recent years, more groups are bringing comprehensive cancer genomic testing in house.
Some laboratorians expressed concern that last week's guidance is a signal of FDA's plans to regulate LDTs broadly in the future.
FDA Reclassifies Certain Hepatitis C Diagnostic Tests, Blood Lancets
The final orders will ease the regulatory burden for some hepatitis C tests, but increase FDA oversight of blood lancets.
The rule calls for using payors' median in-network rates as benchmarks in arbitration, a move labs fear could undermine their negotiating leverage with insurers.
Florida Lab Owner Receives 7 Years in Prison for Role in Kickback Scheme
The scheme took advantage of temporary amendments to telehealth restrictions enacted during the SARS-CoV-2 pandemic, according to the DOJ.