AdvaMed Recommends Steps to Strengthen RAPID Pathway for Breakthrough Medical Technologies

WASHINGTON, D.C.—AdvaMed, the Medtech Association, today recommended refinements the Centers for Medicare & Medicaid Services (CMS) could make to help its proposed Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway deliver more timely access to breakthrough medtech for Medicare beneficiaries. 

“Medicare beneficiaries shouldn’t have to wait for FDA-authorized breakthrough technologies that could improve their health and even save their lives,” said Scott Whitaker, AdvaMed president and CEO. “CMS has taken an important step toward that goal with RAPID. With the improvements we recommend, the program can reach its full potential to provide the clear, predictable pathway needed to ensure patients get timely access to the latest medtech innovations.” 

“We support CMS’s efforts to reimagine Medicare coverage and establish a more predictable pathway for breakthrough-designated devices,” wrote Amber Stock, Vice President, Payment & Health Care Delivery Policy at AdvaMed, in a comment letter to CMS. “RAPID has the potential to improve beneficiary access to important innovations while providing greater regulatory certainty for developers. As CMS continues to pursue coverage reform and Medicare modernization, we respectfully offer the following comments for CMS’s and FDA’s consideration and re-emphasize our commitment to working with both agencies to create stable, predictable, and accessible coverage pathways for innovative technologies.” 

AdvaMed recommended that CMS and FDA: ensure RAPID is adequately resourced, transparent, and aligned with FDA’s risk-based regulatory framework; broaden eligibility for breakthrough-designated devices; avoid unnecessary procedural barriers; allow appropriate participation by diagnostics; establish firm timelines for national coverage determinations; coordinate coverage, coding, and payment; and create transition protections for technologies already developed or planned under prior CMS coverage pathways. 

AdvaMed said these improvements are consistent with its longstanding advocacy for faster patient access to breakthrough medical devices and would help RAPID achieve CMS’ goal of promoting earlier coordination and more predictable coverage while ensuring Medicare beneficiaries can access breakthrough medical technologies without unnecessary delay. 

About AdvaMed 

AdvaMed, the Medtech Association, represents the world’s leading medical technology companies that develop medical devices, diagnostic products, digital health technologies, and health information systems that are transforming health care through earlier disease detection, less invasive procedures, and more effective treatments.