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The cell collection device already has FDA clearance, while the firm intends to conduct trials in support of a filing for marketing clearance of the assay.
A bi-weekly listing of recent local coverage determinations from Medicare Administrative Contractors.
The revisions include information on demonstrating accuracy and how to design a single set of comparison and reproducibility studies for dual 510(k) and CLIA waiver submission.
The bipartisan bill is backed by more than 250 organizations, but ACMG remains opposed, arguing that ordering tests is part of the practice of medicine.
Medicare Administrative Contractor Palmetto released its final local coverage decision last year, and WPSIC has now aligned its coverage.
Scheduled to go into effect next year, CMS' price transparency regulations could drive down reimbursements but also streamline billing for hospital labs.
The final national coverage decision stipulates that NGS germline tests for assessing hereditary breast and ovarian cancer risk must have FDA's blessing.
A pair of lawyers familiar with the case said that while ACLA might not win the legal battle, its lawsuit could aid efforts to get a legal fix to the law.
Ravitej Reddy pleaded guilty in federal court to allegations he illegally billed Medicare for cancer genomic testing and pharmacogenetic testing.
Abbott highlighted its next-generation Alinity platforms, and Caris discussed its plans to provide precision oncology services.