CMS and FDA Announce RAPID Medicare coverage for Breakthrough Medical Devices

In April, the Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA) introduced a pathway the could reduce the time it takes Medicare beneficiaries to access breakthrough medical devices from a year to about two months. The initiative, the Regulatory Alignment for Predictable and Immediate Device (RAPID), allows CMS and FDA to work together, with innovators, early during technology development. RAPID would allow CMS access to evidence generated by FDA review to support its Medicare coverage decisions. Aligning regulatory and coverage expectations in advance should reduce delays that historically occur between FDA market authorization and Medicare national coverage determination.

The expedited pathway is for FDA-designated Class II and Class III Breakthrough Devices. It is available for Class II devices participating in the FDA Total Product Life Cycle Advisory Program (TAP) and Class III devices regardless of whether they are participating in TAP. Under RAPID, CMS would issue a proposed NDC the same day an eligible device participating in RAPID receives FDA market authorization, triggering the statutory 30-day public comment period.

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. 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. CMS Administrator Dr. Mehmet Oz.

Read more about RAPID here.