Fighting the FDA’s Final Rule on LDTs
CEO Laurie Menser discusses the Association for Molecular Pathology’s court case against the FDA’s rule on laboratory-developed tests.
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Getting Started with the FDA’s New LDT Rule
Experts explain what the phase-in process will look like—and how labs can get ahead of the game.
Transitioning the Clinical Lab
What clinical laboratory professionals need to know about healthcare provision for transgender and nonbinary patients
Industry Buzz: ACLA Goes for Kill in PAMA Lab Fees Challenge Case
From - Laboratory Industry Report
Attorneys for the American Clinical Laboratory Association asked the federal court for summary judgment in its lawsuit challenging…
PAMA-geddon: Lab Industry Asks Court to Stop New Medicare Fee Schedule
From - Laboratory Industry Report
With CMS refusing to back down, the lab industry has escalated the dispute and asked a U.S. District Court to step in and prevent enforcement of the 2018 PAMA-inspired…
Genetic Profiling: Study Casts Doubt on Cost-Effectiveness of Leading Breast Cancer Recurrence Assay
From - Laboratory Industry Report
Among the many genetic profiling assays entering the commercial market, few have been more successful than Genomic Heath's Oncotype DX, which is now covered by most of …
CMS Finalizes Controversial PAMA Fee Schedule
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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…
High-Deductible Plans Tied to Reduced Use of Health Care, Including Diagnostic Testing
From - Laboratory Industry Report
People enrolled in high-deductible health plans (HDHPs) cut their use of health services, including laboratory testing, according to…
Employment Law Update: The Weinstein Edition
By Mike O'Brien bio
Your news feed, like mine, has exploded with references to someone named Harvey Weinstein for the past few weeks. What's up? Weinstein is…
Laboratories Increasing Customer-Focus
From - Laboratory Industry Report
Laboratories have always had a strong service component—both for their referring physicians and the patient. However, laboratories are now in the midst of a…
PAMA-Geddon: CMS Slashes 2018 Part B Lab Rates
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Draft 2018 CLFS Reveals Fundamental Flaws in PAMA Reporting Exercise; Time to Take Action
By Lâle White bio
As XIFIN predicted, the PAMA reporting exercise has resulted in significant proposed laboratory fee cuts. In fact…