Closing the Gap Between FDA Approval and Medicare Coverage: Our Recommendations to CMS on the RAPID Pathway
At Guidance Global Consulting (GGC), we believe healthcare innovation should not stop at regulatory approval. A new technology can demonstrate clinical promise and receive authorization from the Food and Drug Administration (FDA), yet patients may still face significant delays before Medicare covers it. Closing that gap requires better coordination between federal agencies, clearer evidence standards, and policies designed with real-world implementation in mind.
That is why GGC, in partnership with Profound Ventures, submitted a joint public comment to the Centers for Medicare & Medicaid Services (CMS) on its proposed Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway (CMS-3487-NC).
I co-authored the comment with Brian Meshkin, Managing Partner of Profound Ventures, bringing together complementary perspectives on federal healthcare policy, clinical quality, medical technology innovation, and investment.
Having drafted federal regulations at CMS on national healthcare quality, payment, and performance measurement, and led teams responsible for developing and implementing these policies, I understand how important public comments are in shaping policies that are practical, effective, and responsive to the needs of patients and providers. I also know how critical it is for FDA and CMS to align early on the clinical outcomes that matter most to Medicare beneficiaries.
Why RAPID Matters
Historically, FDA authorization and Medicare coverage have operated through separate processes, creating uncertainty for innovators and potentially delaying patient access to new technologies.
RAPID offers an opportunity to change that. Under the proposed pathway, FDA, CMS, and manufacturers would engage earlier in device development to agree on the clinical evidence needed to demonstrate meaningful health benefits for Medicare beneficiaries.
For eligible breakthrough devices that successfully complete the pathway, CMS would issue a proposed National Coverage Determination (NCD) on the same day as FDA market authorization, with a goal of finalizing coverage approximately 60 to 90 days later.
This alignment could represent an important shift in how federal agencies support healthcare innovation. Rather than requiring manufacturers to navigate disconnected regulatory and coverage expectations, RAPID would create a more coordinated process.
But speed alone is not enough. The pathway must also be predictable, inclusive, evidence-based, and operationally feasible.
Our Recommendations: Making RAPID Work in Practice
Our public comment supports the overall direction of RAPID while identifying several areas where CMS can strengthen its design and implementation.
- Establish clear timelines and accountability.
A faster coverage pathway is valuable only if innovators can depend on it. We recommended that CMS publish timelines for each major step, provide timely feedback on clinical study protocols, and report quarterly on the pathway’s performance. Predictability matters not only for manufacturers but also for investors, clinicians, and ultimately patients awaiting access to promising treatments.
- Ensure emerging technologies and existing studies are not left behind.
We recommended a transition period of at least 24 months for qualifying devices already undergoing clinical studies, allowing manufacturers to build on existing evidence rather than unnecessarily restart research. We also urged CMS to consider breakthrough diagnostics, AI-enabled technologies, and software-based medical devices when a national coverage pathway is appropriate. As healthcare technology evolves, coverage policy must be flexible enough to accommodate innovation without compromising clinical evidence or patient safety.
- Focus evidence requirements on outcomes that matter to patients.
One of our central recommendations was for CMS to clearly define meaningful health outcomes for Medicare beneficiaries. These should include measures such as survival, physical function, symptom improvement, reduced hospitalizations, independence, and quality of life. We also encouraged proportionate evidence requirements and appropriate use of real-world data, registries, and innovative study designs. The goal should not simply be to generate more evidence. It should be to generate the right evidence to inform better coverage decisions and improve patient outcomes.
- Make coverage with evidence development the exception, not the default.
Coverage with Evidence Development (CED) can be useful when additional clinical information is necessary. However, open-ended study requirements can create uncertainty, administrative burden, and unintended barriers to care. We recommended that any additional evidence requirements be identified early, aligned with FDA studies when possible, and tied to specific outcomes and a defined reassessment timeline. This approach would preserve scientific rigor while avoiding unnecessary duplication and delays.
- Plan for implementation, not just the coverage decision.
A national coverage decision does not automatically mean patients can access a technology. CMS must also coordinate coding, payment, claims processing, provider guidance, and Medicare Advantage implementation. We recommended that operational readiness become part of RAPID’s success criteria. CMS should evaluate not only how quickly a coverage decision is issued, but also whether eligible beneficiaries can actually receive the technology and whether providers can obtain appropriate reimbursement. This distinction is particularly important. In healthcare policy, successful implementation is what ultimately translates regulatory decisions into meaningful improvements in care.
Bringing the Entire Healthcare System to the Table
We also encouraged CMS to establish a standing stakeholder forum that includes patients, clinicians, manufacturers, Medicare Advantage plans, Medicare Administrative Contractors, quality improvement organizations, and investors.
These stakeholders play important roles in determining whether a newly covered technology is adopted, reimbursed, and accessible in communities across the country.
We specifically highlighted opportunities to leverage CMS’ existing quality improvement infrastructure to support participation by rural and underserved populations in clinical studies and real-world evidence collection.
Finally, we recommended clearer federal guidance on compliance and privacy considerations associated with manufacturer-supported participation in Medicare clinical studies.
From Policy Design to Meaningful Patient Impact
RAPID reflects an important opportunity for CMS and FDA to work together earlier, reduce unnecessary duplication, and establish clearer expectations for healthcare innovators. Government can play a powerful role in enabling innovation by establishing clear, consistent, and proportionate rules while maintaining appropriate safeguards for patients.
At GGC, we approach federal healthcare policy through the combined lenses of regulatory strategy, clinical quality, payment, technology, and implementation. Our experience has consistently reinforced one principle: policy succeeds when it can be translated into measurable improvements in care.
We appreciate the opportunity to contribute to CMS’ consideration of RAPID and look forward to continued engagement on policies that support responsible innovation, sustainable implementation, and improved access to care for Medicare beneficiaries.
Read our joint public comment: CMS RAPID Coverage Pathway, CMS-3487-NC
Anita Monteiro is CEO and Co-Founder of Guidance Global Consulting and a former CMS Senior Executive for Quality Improvement and Innovation. The comment was jointly submitted with Brian Meshkin, Managing Partner of Profound Ventures.
