Veracyte Meets New Medicare Coverage Mandate For Molecular Dx
This article was originally published in The Gray Sheet
Veracyte announced a positive coverage policy from Palmetto GBA Jan. 9 for its Afirma multi-gene expression classifier test, one of the first to go through the Medicare contractor’s new requirements.
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The molecular diagnostic firm is expanding its focus beyond thyroid cancer to lung cancer, with plans to acquire Allegro Diagnostics and its gene expression assay. Allegro’s in-development system offers enhanced risk assessment for the approximately 40 percent of bronchoscopies that are inconclusive for lung cancer.
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The standards needed for reimbursement of molecular diagnostics are changing – especially with respect to genomics-based tests, with their potential impact on public health with respect to screening, prevention, and measuring response to treatment, as well as cost. As the complexity of the assay development and launch process has grown, so too has the emphasis on evidence and clinical effectiveness, as well as the importance of finding better ways to align test coding and reimbursement with clinical value. But a lack of coordination across agencies and commercial players makes an assessment of the impact of any changes on evidence demands problematic.