CMS Proposes Rapid Pathway for Breakthrough Devices

The Centers for Medicare & Medicaid Services (CMS) has released its proposed Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway, intended to give Medicare beneficiaries faster access to certain FDA-designated Breakthrough Devices. 

RAPID would bring CMS, the U.S. Food and Drug Administration (FDA) and manufacturers together earlier in product development. The goal, as stated in its press release, is to align evidence needed for FDA review with evidence  

CMS needs to determine Medicare coverage. 

If finalized, CMS would issue a proposed national coverage determination (NCD) on the same day an eligible device receives FDA market authorization. Following the required review process, national Medicare coverage and payment could potentially begin approximately two months later - compared with a year or more under existing processes. 

Which devices could qualify? 

CMS proposes that RAPID candidates meet all of the following criteria: 

• The device is either a presumptive Class II, FDA Breakthrough-designated device participating in FDA’s Total Product Life Cycle Advisory Program (TAP) and preparing a De Novo request, or a Class III Breakthrough Device preparing a premarket approval application. Class III devices would not have to participate in TAP. 

• The device is in the Investigational Device Exemption pre-submission stage, and the manufacturer plans an IDE study enrolling Medicare beneficiaries. 

• The study will evaluate clinical outcomes FDA considers appropriate, and CMS confirms that achieving those outcomes in Medicare beneficiaries would demonstrate improved health outcomes. 

• Available information does not clearly indicate that the device falls outside a Medicare benefit category. 

• The device is not already subject to an NCD. 

• If FDA-authorized, the device could be separately payable and billed to Medicare. 

• The device is not otherwise excluded from Medicare coverage by law or regulation. 

Meeting these criteria would establish potential eligibility - not guarantee RAPID acceptance, FDA authorization, Medicare coverage or a particular payment level. 

Why RAPID matters to Michigan innovators 

For Michigan medical device companies, RAPID means Medicare strategy may need to begin much earlier. Manufacturers pursuing Breakthrough Device designation should consider Medicare population needs when designing pivotal studies - not after FDA authorization. 

Sponsors may need to enroll Medicare beneficiaries and select endpoints that satisfy both FDA requirements and CMS’s standard for improved health outcomes. This will require early coordination across regulatory, clinical, reimbursement and market-access teams. 

A coordinated evidence strategy could reduce duplicative studies, improve investment predictability and shorten the path to patients. However, the proposed criteria may challenge devices whose studies cannot readily enroll Medicare beneficiaries, whose payment is bundled into another service or whose Medicare benefit category is uncertain. 

Relationship to Other Coverage Pathways 

CMS’s standard NCD processes will remain available. However, the agency plans to pause new candidates for the Transitional Coverage for Emerging Technologies pathway while implementing RAPID, making the proposal especially important for companies considering TCET. 

Opportunity to Comment 

During the 60-day comment period, stakeholders may wish to address: 

• Candidate selection and pathway capacity; 

• Timing and scope of CMS engagement; 

• Medicare beneficiary enrollment expectations; 

• Selection of appropriate clinical outcomes; 

• Treatment of devices under bundled payments; 

• Coordination of coverage, coding and payment; and 

• Transparency of CMS decisions. 

Submitting Comments 

For those wishing to comment, refer to file code CMS-3487-NC.

Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed): 

1. Electronically. You may submit electronic comments on this regulation to https://www.regulations.gov/docket/CMS-2026-2674. Follow the "Submit a comment" instructions. 

2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services,Department of Health and Human Services, Attention: CMS-3487-NC,
   P.O. Box 8010,
   Baltimore, MD 21244-8010.
   Please allow sufficient time for mailed comments to be received before the close of the comment period. 

3. By express or overnight mail. You may send written comments to the following address ONLY:
   Centers for Medicare & Medicaid Services,
   Department of Health and Human Services,
   Attention: CMS-3487-NC,
   Mail Stop C4-26-05,
   7500 Security Boulevard,
   Baltimore, MD 21244-1850. 

MichBio encourages members developing Breakthrough Devices - or supporting their development and commercialization - to review the proposal and consider commenting. Industry input will be essential to creating a pathway that supports both timely patient access and predictable product development.