After the Centers for Medicare and Medicaid Services postponed the start of coverage of certain “breakthrough” medical devices, healthcare companies may wonder what happens next. Two former leaders of CMS and Food and Drug Administration shared their thoughts on HIMSS Digital.
This policy will ensure that medical insurance will cover devices that address unmet medical needs once they are approved or approved by the FDA. Originally proposed last year, As the new leadership of the Biden administration reviewed it, the policy was suspended. It will take effect in September at the earliest.
On the bright side, this policy will allow Medicare covered people to use these devices faster — and it will also provide a quick source of income for the companies that build these devices. The challenge is that the rule may apply to more devices than originally anticipated. At first, it is expected to only apply to two to five devices, and then gradually increase.
“CMS quickly realized that the number of these breakthrough devices and products was much more than they expected. This will be a larger workload and will have a greater impact on health insurance plans than anyone I think. Many. It was expected at first,” Brandi said.
She added that this will require close cooperation between the FDA and CMS.
Amy Abernethy led the FDA’s real-world data work before joining Verily as the president of its clinical research platform. He said that the consistency of the two agencies’ use of real-world data can be used as a way to continue to evaluate these products in the future. For example, these data sets can support the assessment of safety and effectiveness from the perspective of the FDA, as well as the results of interest from the perspective of the CMS.
She said that although the policy does not specify this, it can also establish a framework for equipment so that it can be continuously evaluated after it is removed and throughout its life cycle.
“I think this actually puts us in an interesting place and does send a signal for the future of our community to focus on an interesting area,” she said.
Photo credit: Claude Nakagawa, Getty Images
