CMS and FDA Announce RAPID Coverage Pathway to Accelerate Patient Access to Life-Changing Medical Devices

WHY IT MATTERS

Patients with rare diseases who rely on breakthrough medical devices may now access life-changing treatments months or years faster than through traditional Medicare coverage processes.

The FDA and Medicare (CMS) created a new fast-track pathway called RAPID that helps patients get access to breakthrough medical devices more quickly. This pathway applies to certain advanced devices that treat serious conditions. The goal is to reduce the time between when a device is approved and when Medicare patients can actually use it.

CMS and FDA announce 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.

ASK YOUR DOCTOR

Ask your doctor if you have a condition treated by a Class II or III breakthrough device, and whether the RAPID pathway might apply to your treatment options.