After the Centers for Medicare and Medicaid Services pushed back when they’ll start covering certain “breakthrough” medical devices, healthcare companies might be wondering what’s next. Two former executives from CMS and the Food and Drug Administration shared their thoughts on HIMSS Digital.
The policy would ensure that Medicare would cover devices that meet an unmet medical need once they are approved or cleared by the FDA. Originally proposed last year, the policy has been put on hold as the new leadership of the Biden administration revises it. At the earliest, it would come into force in September.
On the bright side, the policy would allow people with Medicare coverage to access these devices much faster – and also give the companies that build them a quick source of income. The challenge is that the rule could apply to many more devices than originally intended. At first, it was planned to only apply two to five devices, and gradually increase from there.
“Part of what CMS realized pretty quickly was that there were a lot more of these breakthrough devices and products than they had anticipated, and it was going to be a lot more workload and have a much bigger impact on the Medicare program than I think. originally planned, ”Brandy said.
She added that this would require close collaboration between the FDA and CMS in the future.
Amy Abernethy, who led the FDA’s real-world data efforts before joining Verily as chair of Clinical Studies Platforms, said the alignment between the two agencies in the use of data from the real world could serve as a means of continuously evaluating these products in the future. For example, these datasets could support both the safety and efficacy assessment from the FDA perspective, as well as the results of interest from the CMS perspective.
While the policy doesn’t say so specifically, it could also put in place a framework for a device to be continually assessed once it’s wiped and throughout its lifecycle, she said.
“I think it actually puts us in an interesting place and signals an interesting area of interest for our community going forward,” she said.
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