CMS and FDA Announce RAPID Coverage Pathway to Accelerate Medicare Coverage for Breakthrough Medical Devices

Key Takeaways: Faster Medicare Coverage. The Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) have announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, which could enable national Medicare coverage and payment for medical devices as soon as two months after FDA market authorization, compared to approximately a year or more under the current process.... By: Foley Hoag LLP