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Breakthrough Reimbursement Proposals Percolate From FDA, Industry

As industry continues to nudge CMS to follow FDA's lead in making reforms that streamline the path to market for innovative new devices, the agencies are themselves floating solutions. All sides are thinking up strategies to rely on FDA's determination that a device meets certain "breakthrough" standards to trigger a streamlined path to data-conditioned reimbursement. But some in industry are concerned about an overemphasis on national, rather than local, coverage, and, in particular, the Medicare coverage-with-evidence-development process.

The goal of creating a predictable, quicker path to reimbursement for so-called breakthrough technologies that address unmet needs is increasingly on the minds of not only industry leaders, but top brass at FDA and the Centers for Medicare & Medicaid Services, as well.

Multiple executives at the AdvaMed 2015 conference in San Diego repeated the statistic that it was 20-times more difficult to get a positive coverage decision for a breakthrough technology now...

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