Under the Same Sky - Where Regulatory Meets Market Access

For more than a decade, MedTech innovators have faced the same challenge: FDA authorization does not guarantee timely Medicare coverage. RAPID is CMS’s latest attempt to narrow that gap—and potentially one of its most consequential.

The RAPID Sound Bites

RAPID moves reimbursement planning upstream.
Instead of asking what Medicare needs after FDA authorization, RAPID brings CMS into the conversation before the pivotal study is designed.

The promise: one evidence strategy, two agencies.
The goal is to design an IDE study capable of supporting both FDA authorization and a Medicare National Coverage Determination (NCD). 

Consideration: A Medicare NCD does not automatically translate to coverage by non-Medicare commercial payers or state Medicaid programs. Additionally, for broad payer coverage (outside of the RAPID program), evidence generation isn’t a “one and done” approach and requires an ongoing build of evidence to support the value, use case and claims for a technology.

Faster coverage comes with a trade-off.
Innovators may gain greater predictability and a significantly faster NCD timeline—but may need to incorporate Medicare beneficiaries and clinical health outcomes agreed upon by FDA and CMS into the pivotal study.

Consideration: An NCD provides national predictability (with Medicare)—but predictability cuts both ways. If evidence gaps remain, CMS may include Coverage with Evidence Development (CED) as part of the NCD. Would an NCD advance your market access strategy, or could local coverage provide greater flexibility?

Breakthrough designation alone does not make a device RAPID-eligible.
RAPID eligibility is about being early enough to align the evidence—not whether your study carries a significant-risk IDE designation.

Consideration: Are you still at the IDE pre-submission stage, and can your pivotal study incorporate Medicare beneficiaries and clinical health outcomes agreed upon by FDA and CMS before the protocol is locked?

Questions MedTech Leaders Should Be Asking Now

• Are we actually eligible—or are we assuming Breakthrough status is enough?
• Are we early enough in development to engage CMS before our pivotal trial is locked?
• Can our planned IDE study incorporate Medicare beneficiaries and the clinical health outcomes CMS will need to support an NCD?
• Is Medicare a sufficiently important market to justify designing the study around CMS evidence expectations?
• Would an NCD materially change our commercialization, fundraising or adoption strategy?
• Are we willing to broaden enrollment or modify endpoints to satisfy both FDA and CMS?
• Are we planning coverage and payment together?  Faster coverage does not necessarily mean adequate payment.

RAPID May Not Be for Everyone—and That Is the Point

The opportunity is significant, but the eligibility criteria appear intentionally narrow. Some Breakthrough Devices may discover that their regulatory pathway, IDE stage, study design or Medicare coverage/payment characteristics place them outside RAPID eligibility—or that RAPID simply isn’t the best fit for their Medicare strategy.

Consideration: For those companies, the appropriate path may still be a conventional NCD, LCD or claim-by-claim coverage strategy. RAPID currently has no stated numerical participation cap—raising an important question about how CMS will manage volume and maintain its proposed timelines at scale.

Now Is the Time to Pressure-Test the Policy

RAPID has the potential to change how MedTech companies integrate regulatory, clinical and reimbursement strategy—but its value will ultimately depend on how the final framework is structured and implemented.

Consideration: The public comment period for RAPID is open now and runs through October 13, 2026. Stakeholders should use the comment period to do more than support faster Medicare coverage. They should identify where the proposed eligibility requirements, evidence expectations or operational processes could unintentionally exclude technologies that would otherwise benefit Medicare patients.

Ask the harder questions:

Who gets left out?
Which requirements could become unintended barriers?
Can CMS realistically deliver the timelines and scale being proposed?
And what would need to change for RAPID to work for your technology?

Companies, investors, clinical investigators and other MedTech stakeholders should evaluate the pathway against real development programs now—and submit substantive comments to CMS before the policy is finalized.

RAPID may represent an important step toward closing Medicare’s coverage gap. The comment process is the industry's opportunity to help determine whether that promise translates into a pathway that works in practice.

Final consideration: Don’t “hang your hat” on RAPID. Pressure-test RAPID against your existing strategy and maintain an alternative path.

Please reach out to our team if you'd like to discuss what RAPID means for you.