AdvaMed Submits Recommendations to CMS to Strengthen RAPID Coverage Pathway 

October 27, 2026—AdvaMed, the Advanced Medical Technical Association, announced it recommended refinements to the Centers for Medicare & Medicaid Services (CMS) that the agency 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.

In April 2026, CMS and FDA announced the introduction of RAPID to allow the two agencies to work together, with innovators, earlier in the technology development lifecycle so that evidence generated for FDA review can also support Medicare coverage decisions.

The pathway was designed to expedite access to certain FDA-designated class II and class III Breakthrough Devices for patients with Medicare, stated CMS and FDA in the April announcement.

As summarized in its press release, the AdvaMed recommendations for CMS and FDA include the following:

• 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.
• Create transition protections for technologies already developed or planned under previous CMS coverage pathways.

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

“Medicare beneficiaries shouldn’t have to wait for FDA-authorized breakthrough technologies that could improve their health and even save their lives,” commented AdvaMed President and CEO Scott Whitaker in the press release. “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.”