By Christopher P. Young, Editor, G2 Compliance Advisor
A long standing issue in the laboratory industry is once again under scrutiny as the result of a U.S. Department of Health and Human Services' Office of Inspector General (OIG) Advisory Opinion (AO 15-04) posted on March 25 on its website. AO 15-04 warns that the practice of writing off charges for patients of exclusive insurance contracts by laboratories that are not contracted with that insurance, may constitute prohibited remuneration under the Anti-Kickback statute (AKS).
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By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies
Blue Cross Blue Shield (BCBS) of Michigan and the University of Michigan Health System are collaborating with physicians and laboratories across the state to improve molecular testing practices. The Genetic Testing Resource and Quality Consortium (GTRQC), a quality improvement initiative, hopes to empower medical professionals with tools to better determine whether genetic testing should be used and which test(s) will most improve patient outcomes.
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By Ron Shinkman, Editor, Laboratory Industry Report
San Diego-based Agena Biosciences has released a new testing platform that provides a quick and accurate identification of variations in most non-small cell lung cancers.
The platform, known as the LungFusion panel, performs 13 separate assays in total and focuses on three gene fusions specific to non-small cell lung cancer: ALK, RET, and ROS1. Rearrangements of these genes can provide clinicians with more data as to how the cancer may progress and how it may be treated.
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By Stephanie Murg, Managing Director, G2 Intelligence
As the U.S. Food and Drug Administration (FDA) evaluates its role in regulating next-generation sequencing (NGS)-based diagnostic tests, a range of stakeholders have responded to the agency's request for feedback in the wake of its February 20 public workshop on the topic. Among the notable submissions are written comments submitted recently by the Association for Molecular Pathology (AMP; Bethesda, Md.). The non-profit organization urged FDA to focus on helping to ensure the performance characteristics of NGS instruments, reagents, and related software. AMP also recommended that FDA partner with private sector organizations and experts to set standards for FDA-cleared or approved instruments, test kits, and software.
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By Kelly A. Briganti, Editorial Director, G2 Intelligence
The U.S. Department of Health and Human Services (HHS) launched a new resource last week to further the goal of value- and quality-based reimbursement. The Health Care Payment Learning and Action Network offers an opportunity for public and private organizations, payers, providers, consumer groups and even individual consumers to dialogue about the best way to achieve (and exceed) the thresholds HHS set for moving Medicare payments to alternative payment models that focus on quality rather than quantity.
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