Molecular Dx Reimbursement: Medicare Contractor Seeks Tighter Controls
This article was originally published in The Pink Sheet Daily
West Coast contractor Palmetto issues draft proposal establishing a"non-coverage" policy for molecular tests not explicitly covered by Palmetto or a national CMS directive.
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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.
In 2011, sequencing was once again the big story in diagnostics. But unlike 2010 when the big news was the successful IPOs of next-generation sequencing companies Pacific Biosciences and Complete Genomics, the tone in 2011 was more nuanced.