New pathway cuts red tape and brings predictability to Medicare coverage for Breakthrough Devices Today, the Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, a new pathway designed to expedite access to certain FDA-designated Class II and Class III Breakthrough Devices for people with Medicare.
“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 American people deserve timely access to meaningful treatments without red tape or high costs," said FDA Commissioner Marty Makary, M.D., M.P.H. "In this administration, FDA and CMS are functioning as a single team to deliver life-saving Breakthrough Devices to American patients as soon as we know they work,” said FDA Commissioner Marty Makary, M.D., M.P.H.
FDA News Releases published a clinical update in Research Highlights on 23 Apr 2026.
The item focuses on CMS and FDA Announce RAPID Coverage Pathway to Accelerate Patient Access to Life-Changing Medical Devices.
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