Recommendations to CMS on the Proposed RAPID Coverage Pathway

RAPID Pathway Notice 

CMS-3487-NC  

Rubrum Advising appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) proposed procedural notice establishing the Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway. We appreciate CMS’s work to meaningfully reduce the current gap between Food and Drug Administration (FDA) market authorization and national Medicare coverage and support CMS’s goal of issuing a proposed NCD on the same day that FDA authorizes an eligible RAPID device.  

Rubrum Advising is a healthcare advising and solutions firm that helps clients and customers bring innovative health solutions, therapies, and technologies to people sooner. We work with innovators, manufacturers, providers, investors, patients and other stakeholders to develop practical end-to-end strategies that address federal requirements and healthcare system realities to achieve sustainable implementation and patient access. This experience informs our support for CMS’s objective of reducing the time between FDA market authorization and a Medicare national coverage determination (NCD) for eligible Breakthrough Devices.  

The proposed RAPID pathway appropriately recognizes the value of facilitating earlier dialogue among FDA, CMS, and manufacturers. Such engagement can help manufacturers design studies that account for Medicare evidence requirements and generate evidence relevant to both agencies’ decision-making processes. We view the RAPID proposal as a meaningful step toward accelerating coverage of innovative technologies. For RAPID to have a meaningful impact on the innovation ecosystem, it should be sustainable, predictable with clear guidelines, properly resourced, and should not cause delays in non-RAPID coverage decisions.  

We encourage CMS to prioritize the long-term sustainability of the process and to establish a strong foundation for potential future expansion. With that in mind, we have the following recommendations to strengthen the RAPID process: 

Refine RAPID Eligibility to Capture Appropriate Technologies 

1. IDE Pre-Submission Cutoff and Transitional On-Ramp

CMS proposes to limit eligibility to devices at the IDE pre-submission stage and seeks comment on whether devices that have progressed beyond that point, including devices already being studied under an IDE, should be excluded. Rubrum agrees that early engagement is critical and that in many cases, the pivotal IDE pre-submission stage will provide the best opportunity for FDA and CMS feedback to influence the pivotal protocol before study design is fixed. We request that CMS clarify that this limitation applies only to pivotal IDE studies and that sponsors can be eligible if they have conducted first in human, early feasibility, or feasibility trials – but have not yet conducted the pivotal trial that will support their FDA marketing submission.    

Moreover, we believe IDE pre-submission timing should not currently be a strict boundary. As proposed, the requirement may exclude otherwise appropriate technologies merely because their sponsors began FDA engagement before RAPID became available or before the sponsor could reasonably know the new pathway’s process. CMS should consider establishing a transitional on-ramp for otherwise eligible devices that are already being studied under an IDE and approved for payment by CMS.  

2. RAPID Eligibility Should Not Depend on Payment Methodology 

Medicare frequently covers items and services through payment methodologies that package, bundle, or otherwise incorporate payment into a related service, and the payment mechanism may vary depending on the site of care and the applicable payment system. Rubrum Advising recognizes that, to be eligible for coverage under RAPID, a technology must fall within an existing Medicare benefit category. However, how a covered benefit is paid should not be a factor in determining eligibility for an accelerated coverage pathway. A technology that meets the benefit category requirement and the applicable evidentiary standards should be eligible, if appropriate, for RAPID regardless of whether it would be paid separately or through a packaged or bundled payment. Because Medicare coverage determinations apply to both Original Medicare and Medicare Advantage, the payment methodology that applies in the Original Medicare program should not be a barrier to accelerated coverage for innovative technologies. 

We recommend that CMS clarify in the final notice that a technology satisfies RAPID’s eligibility criteria if it falls within an existing Medicare benefit category and meets the applicable evidentiary standards, regardless of whether payment for the technology is made separately or is packaged, bundled, or otherwise incorporated into payment for a related service.  

Additional Sub-Regulatory Guidance is Needed 

Rubrum Advising encourages CMS to use its authority under section 1862(l) of the Social Security Act to issue sub-regulatory guidance clarifying the evidentiary factors CMS will consider when evaluating RAPID applications. Section 1862(l) directs the Secretary to make public the factors considered in NCDs and to develop guidance documents in a manner similar to FDA guidance under section 701(h) of the Federal Food, Drug, and Cosmetic Act. That process is well suited to giving manufacturers predictability early in pivotal study design. Specifically, we recommend that where existing guidance does not provide clarity, such guidance address: 

1. Representation of Medicare beneficiaries in the pivotal study, including clinically relevant subgroups and patients with common comorbidities, and how CMS will weigh prespecified subgroup analyses in assessing the population for which the evidence supports coverage. 
2. Appropriateness of the comparator, including when standard care, an active comparator, historical controls, or another approach may be suitable. 
3. Selection of clinical outcomes meaningful to Medicare beneficiaries, such as function, morbidity, mortality, health-related quality of life, avoidance of hospitalization, or other patient-centered outcomes appropriate to the technology and indication. 
4. Safety, durability, and follow-up expectations, including how the appropriate duration of follow-up may vary by device risk, intended use, and expected timing of benefit. 

Update CED Guidance to Reflect the RAPID Pathway

Rubrum Advising supports CMS’s use of coverage with evidence development (CED) to give beneficiaries access to items and services that show promise but whose evidence does not yet meet the reasonable and necessary standard. The notice states that RAPID will not alter existing standards for the NCD process or CED, and we agree that CMS’s 2024 CED guidance remains the appropriate framework. 

When a RAPID NCD is issued under CED, FDA-required postmarket studies may be designed to also meet CED requirements. This can reduce duplicative or sequential studies while still producing the evidence CMS needs. We encourage FDA and CMS to continue providing joint guidance on this alignment following evidence review, when the evidence gaps for a specific technology are known.  

Integrating RAPID Within CMS’s Broader Coverage and Payment Processes  

The ability of RAPID to achieve its goals will depend not only on the design of the pathway itself, but also on how it fits within CMS’s broader coverage and payment processes. That success matters to both manufacturers and Medicare beneficiaries. For manufacturers, a predictable and well-functioning pathway makes it possible to plan evidence generation, product launch, and market access with confidence, reducing the uncertainty that can deter investment in innovative technologies. For beneficiaries, this translates to earlier access to technologies that can improve health outcomes with greater assurance that those technologies are supported by evidence relevant to the Medicare population. We offer recommendations in three areas: the future of the TCET pathway, prioritization and transparency across CMS’s national coverage workload, and the necessary operational steps that follow a favorable coverage determination. 

1. The future of TCET: Rubrum acknowledges that CMS has paused the TCET pathway for new candidates to focus on RAPID implementation. However, we encourage retention of TCET as an option for manufacturers, particularly those whose technologies do not meet RAPID’s eligibility requirements. CMS should clarify its plans for TCET, including whether and when it will resume accepting new candidates and how manufacturers may pursue the pathway while RAPID is being implemented. 
2. Prioritization and transparency: Maintaining several coverage pathways raises the question of how CMS will prioritize NCD requests across RAPID, TCET, and its regular NCD workload, including reconsiderations. We recognize, and appreciate, the work CMS has done to keep the existing NCD Dashboard up to date. As RAPID is implemented, we encourage CMS to continue to build on the information provided in the NCD Dashboard so stakeholders can see how participation in a particular pathway affects a request’s priority and expected review timeline. Expedited review for RAPID participants should not cause undue delays for other technologies and services waiting for national coverage review. We recommend the agencies publish a dashboard or companion report that details aggregate performance information by pathway. That information could include the number of requests received, accepted and completed, and the time from request to final decision. For RAPID, this could include the number of inquiries and accepted participants, common reasons for ineligibility, withdrawals, time from entry to FDA authorization, time from authorization to proposed and final NCDs, and use of CED. Reporting should also cover pending TCET and other non-RAPID NCD requests and reconsiderations, including time awaiting the opening of a review and time spent completing an active review. Such reporting should protect confidential commercial information while allowing stakeholders to evaluate whether RAPID is meeting its objectives without slowing the coverage process elsewhere.
3. Implementation following coverage. Finally, a favorable NCD is only the first step toward beneficiary access. CMS should provide additional information on how RAPID will interact with CMS functions outside of CCSQ, including benefit category determinations, coding processes, transitional payment mechanisms, and other Medicare payment pathways, so that manufacturers have greater certainty about the operational steps that follow coverage. We encourage CCSQ/CAG and CM staff to develop and maintain the infrastructure needed to ensure seamless and timely implementation of RAPID NCDs.   

 Conclusion 

Rubrum Advising supports the goals of the RAPID pathway, under which CMS will work in parallel with FDA to advise manufacturers of eligible Breakthrough Devices on IDE trial endpoints relevant to clinical utility, so that the pivotal study can support an NCD shortly after FDA market authorization.  

We respectfully encourage CMS to finalize RAPID with the clarifications recommended in these comments, including updated sub-regulatory guidance on evidentiary expectations, refinements to the eligibility criteria, and greater clarity on how RAPID will interact with TCET, CMS’s broader NCD workload, and Medicare payment processes. 

Thank you for the opportunity to submit these comments. Rubrum Advising would welcome the opportunity to discuss these recommendations further.