CMS and the FDA have proposed a new coverage policy to change Medicare beneficiaries access to certain FDA-designated Class II and Class III breakthrough devices.
According to an April 23 FDA news release, the Regulatory Alignment for Predictable and Immediate Device coverage pathway is designed to expedite access to these devices.
“FDA and CMS each play a critical role in getting new medical devices to patients, and they work most effectively when aligned sooner in that process,” said CMS Administrator Dr. Mehmet Oz. “The RAPID coverage pathway brings our two agencies together earlier, cutting red tape for innovators, and helping beneficiaries access new, life-changing health technology faster.”
The RAPID pathway will cover Class II participating in the FDA Total Product Life Cycle Advisory Program and Class III devices regardless of whether they are participating in TAP. According to the release, the RAPID pathway will support CMS in releasing National Coverage Determinations for breakthrough devices on a shortened timeline of less than one year, as opposed to the year-plus it currently takes to finalize those policies.
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