By Stephanie Murg, Managing Director, G2 Intelligence
What a difference a year makes. That was the prevailing sentiment at the opening sessions of the 20th annual meeting of the American Clinical Laboratory Association (ACLA), which runs through today at the Grand Hyatt in Washington, D.C. In the months since the trade group last convened, the Protecting Access to Medicare Act of 2014 (PAMA) became law, the FDA issued draft guidance on laboratory-developed tests (LDTs), and, just weeks ago, the sustainable growth rate…
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By Kelly A. Briganti, Editorial Director, G2 Intelligence
As an Oregon health care insurer just experienced, if your lab suffers an information security breach, even due to a lost laptop or flash drive, the Health Insurance Portability and Accountability Act (HIPAA) requires your lab notify the Office for Civil Rights. And if more than 500 individuals could be affected, you'll have to provide public notice of the breach. Last week, Oregon's Health CO-OP issued a press release about a stolen laptop. Although it reports no medical information was stored on the laptop it did contain…
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By Christopher P. Young, Editor, G2 Compliance Advisor
Aetna alleges Health Diagnostic Laboratory, Inc. (HDL), and Bluewave Healthcare Consultants, Inc. used kickbacks and inducements to redirect referrals for laboratory testing to HDL, an out-of-network laboratory, causing Aetna to pay twice as much as it would if equally qualified in-network laboratories performed those tests. Aetna seeks to…
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By Ron Shinkman, Editor, Laboratory Industry Report
Adaptive Biotechnologies has said it has developed an assay to help detect Hodgkin's disease through a blood draw.
The Seattle-based Adaptive worked with the University of Texas MD Anderson Cancer Center in Houston to develop the test, which focuses on identifying populations of B cells that can detect tumor-specific DNA sequences. Hodgkin's disease is characterized by the presence of malignant Hodgkin Reed-Sternberg cells, which are…
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By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies
Although there is general interest in receiving genomic results from sequencing study participation, most people do not expect researchers to go out of their way to screen for incidental findings (IFs) in a research setting, according to a survey of nearly 7,000 participants. The study, published April 29 in the European Journal of Human Genetics, surprisingly, found substantial differences in …
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