Is an NCD the Right Move for Your Technology? Lessons from CMS’s Final Decision on Renal Denervation
Nicole Coustier has over 20 years of experience in U.S. Reimbursement and Market Access and has helped early-stage MedTech achieve widespread reimbursement coverage in the U.S.
When CMS issued its final decision memo on radiofrequency and ultrasound renal denervation (RDN) for uncontrolled hypertension, it made a nuanced choice—coverage under defined conditions through Coverage with Evidence Development (CED).
This decision, outlined in CMS Decision Memo CAG-00470N, doesn’t represent open-ended national coverage, nor a categorical denial. Instead, it reflects CMS’s careful balancing act: granting conditional access to promising technology while requiring ongoing evidence to confirm clinical value for the Medicare population.
For MedTech innovators aiming to commercialize in the U.S., this decision offers a critical case study in how CMS evaluates technology for national coverage, and when it makes sense to seek an NCD at all.
What an NCD Really Means
A National Coverage Determination (NCD) establishes whether a device or procedure is “reasonable and necessary” for Medicare beneficiaries. Once finalized, the policy binds all Medicare Administrative Contractors (MACs), replacing local variability with a single national standard. That uniformity can accelerate adoption when coverage is favorable, but it also fixes CMS’s position across the country.
In the RDN case, CMS’s final decision explicitly defines who qualifies, who can perform the procedure, where it can be done, and how it must be studied. Patients must have sustained uncontrolled hypertension despite guideline-directed therapy and lifestyle modification, and must be evaluated for secondary causes of hypertension. Physicians must meet interventional training requirements, and facilities must have the appropriate infrastructure for hypertension management. Importantly, use of the devices is limited to CMS-approved CED studies that collect real-world outcomes over a minimum of twenty-four months. In short, CMS conferred coverage—but only in a research context that continues to build the evidence base.
What CMS Saw in Renal Denervation
Renal denervation addressed a large, clinically significant population—millions of Americans with hypertension, including many Medicare beneficiaries. Trials demonstrated meaningful blood-pressure reductions, yet variability remained across studies, and long-term clinical outcomes such as cardiovascular events and mortality were still uncertain. CMS recognized the therapy’s potential but concluded that more data were needed to confirm durable benefit and generalizability to older patients.
By invoking CED, CMS allowed access while maintaining scientific rigor. For innovators, this illustrates how CMS distinguishes between technologies ready for full coverage and those that remain promising but incomplete.
When CMS Takes Up an NCD
CMS initiates NCDs when technologies reach a tipping point of national significance—either because they affect a broad population, intersect with multiple care settings, or represent a class of emerging technologies generating uncertainty across regions. The agency tends to act when local coverage differences threaten consistency or when evidence questions the applicability of an intervention in the Medicare population.
The RDN case fits that mold: widespread clinical interest, multiple FDA-approved systems, and a rapidly evolving evidence base that warranted centralized policy. CMS’s goal was not to halt innovation but to shape it toward evidence generation that supports confident national adoption.
When an NCD Strategy Makes Sense
An NCD can be the right path when a technology’s evidence base is mature, patient selection is standardized, and clinical practice is stable. Technologies that directly address conditions prevalent in the Medicare population, have robust multicenter data demonstrating patient-centered outcomes, and enjoy alignment among specialty societies often benefit from a national framework. For these, national coverage can validate legitimacy, accelerate consistency, and reduce administrative friction.
However, innovators should not assume that national coverage automatically equals commercial success. An NCD sets the terms of engagement for the entire program—indications, settings, practitioner criteria, and sometimes data-collection obligations. Entering that process prematurely can institutionalize limitations that are difficult to revise later.
When an NCD Doesn’t Make Sense
For emerging or early-evidence technologies, an NCD can backfire. If the evidence remains heterogeneous or outcomes depend heavily on surrogate endpoints, CMS may impose narrow conditions or restrict use to research. Once that national policy exists, it preempts local flexibility. Technologies still evolving in trial design, procedural technique, or target population are better served by incremental local coverage that allows learning and adaptation before a national framework is fixed.
Two Contrasting Examples
Consider transcatheter aortic valve replacement (TAVR). By the time CMS established an NCD, TAVR had multiple randomized trials proving mortality and quality-of-life benefit, a clearly defined elderly patient population, and standardized procedural practices. The NCD formalized access and ensured safety through hospital and team criteria, aligning perfectly with the technology’s maturity and Medicare relevance.
Contrast that with renal denervation. The therapy has strong scientific rationale and growing evidence but persistent uncertainty about durability and applicability to older, more complex patients. CMS’s decision to grant CED coverage reflects both encouragement and caution, a structured bridge between innovation and certainty. It allows data collection without granting unqualified nationwide use.
Strategic Lessons for Innovators
The renal denervation decision underscores a broader truth: timing matters as much as data quality. Before seeking an NCD, innovators should evaluate whether their technology can withstand national scrutiny. FDA approval may establish safety and efficacy, but CMS asks a different question—does the intervention improve meaningful outcomes for the Medicare population in real-world conditions?
Building that case often requires additional post-market studies, registry data, and alignment with clinical guidelines. Engaging societies early and coordinating data standards can position a company for smoother CED participation or eventual expansion to full coverage once evidence gaps close. Conversely, rushing into an NCD may crystallize restrictive conditions that are difficult to unwind.
Final Thought
CMS’s final decision on renal denervation demonstrates that “coverage” is not binary. Conditional coverage under CED represents a pragmatic bridge between innovation and certainty. For MedTech leaders, the lesson is that an NCD can accelerate adoption when the evidence is mature and the population well defined, but it can also slow progress if sought too soon (or inappropriately sought in the first place).
The real question isn’t whether your technology deserves national attention, but whether it’s ready for it.
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