What will happen with CMS’ policy to cover breakthrough medical devices? 

After the Centers for Medicare and Medicaid Services pushed back the date for when it will start covering certain “breakthrough” medical devices, healthcare companies might be wondering what comes next.  Two former leaders with CMS and the Food and Drug Administration shared their thoughts at HIMSS Digital.

The policy would ensure Medicare would cover devices that address an unmet medical need once they are approved or cleared by the FDA. Originally proposed last year, the policy was put on pause as new leadership under the Biden Administration reviews it. At the earliest, it would go into effect in September.

On the upside, the policy would allow people covered by Medicare to access these devices much faster — and would also give the companies building them a swift source of income. The challenge is that the rule might apply to many more devices than originally intended. At first, it was expected to only apply to two to five devices, and gradually increase from there.

“Part of what CMS realized fairly quickly was that there were a lot more of those breakthrough devices and products than they anticipated, and it was going to be a much bigger workload and have a much bigger impact on the Medicare program than I think anyone had originally anticipated,” Brandy said.

She added that it would require close collaboration between the FDA and CMS going forward.

Amy Abernethy, who spearheaded the FDA’s real-world data efforts before joining Verily as its president of clinical studies platforms, said alignment between the two agencies in using real world data could serve as a way to continuously evaluate these products in the future. For example, these datasets could support both the evaluation of safety and effectiveness from an FDA perspective, as well as the outcomes of interest from CMS perspective.

Although the policy doesn’t specifically say this, it could also set up a framework for a device to be continually evaluated once it’s cleared and throughout its lifecycle, she said.

“I think that actually puts us in an interesting place and does signal for an interesting area of focus for our community for the future,” she said.

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