Why this Newsletter
This new pathway could be of interest to companies who are developing class III devices and tests and certain class II devices and tests and believe that national Medicare coverage is an important U.S. commercialization milestone. The new pathway is called Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway.
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Regulatory Alignment for Predictable and Immediate Device (RAPID) pathway is expected to provide predictable national Medicare coverage at or soon after US launch. This is in contrast to most national Medicare coverage pathways, where CMS requires FDA authorization before starting the national coverage determination (NCD) process.
Companies with eligible US FDA designated Breakthrough Devices who participate in the RAPID pathway should expect changes to development, evidence generation, and reimbursement and coding strategy, including earlier engagement by CMS and a focus on Medicare-relevant clinical outcomes, and a tighter integration of regulatory and Medicare reimbursement planning.
The RAPID pathway is another mechanism designed to accelerate Medicare beneficiary access to eligible devices with eligible US-FDA designated Breakthrough Designation. Medicare beneficiaries include people over the age of 65 years or under the age of 65 with certain mental/physical disabilities and kidney dialysis patients.
Participation in RAPID will involve major trade-offs. Because CMS’s and other health insurance payers’ evidentiary bars are typically higher than FDA authorization needs, IDE studies for medical devices in the RAPID program may be more robust, require larger enrollment and participation by Medicare beneficiaries, outcomes specific to CMS but not the FDA, and longer follow-up times than most studies supporting devices solely for FDA authorization.
Depending on the circumstances the end result could be higher risk of trial failure. The following comments could be helpful to consider,
• Do you think it’s worthwhile to accept CMS suggestions?
• How much will adapting your IDE study as requested by CMS add to the study’s cost.
• How much longer will the study take?
• Will the trial fail based on the endpoints CMS has requested?
• Will your pricing strategy change to account for higher costs and longer time to get to market?
• Will the feedback be clear as to which endpoints FDA requires for authorization and which CMS requires for making their National Coverage Decision?
o If so, what happens if you meet FDA endpoints but fail to meet CMS endpoints?
o If not, and if they are “joint” endpoints, are you willing to accept the risk of failure? Why accept this risk?
For more information visit https://rowinskigroup.com or contact Daniel Zimmerman at info@rowinskigroup.com
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About Rowinski Group
2026 marks the 22nd year in business for Rowinski Group LLC. Rowinski Group is a global reimbursement and healthcare payer data analytics consultancy for medical devices, digital health and diagnostics companies who are developing for and selling in the U.S healthcare market. Rowinski Group has offices in Silicon Valley – San Francisco Bay area, Minneapolis and Portland.
Rowinski Group has two core service offerings; securing codes and reimbursement on behalf of our company clients and using healthcare payer data analytics to help our companies solve their business issues like responding to questions from the FDA and Medicare, sales forecasting, building marketing models, Key Opinion Leader (KOL) identification.
Through these service offerings Rowinski Group helps companies from around the work to establish and build their U.S. market share.
