This NCA will focus on the clinical indications for use of RDN among Medicare beneficiaries. This NCA will analyze clinical evidence for characteristics or comorbidities that make patients more or less likely to benefit from RDN and whether specific treatment conditions are necessary to achieve the outcomes demonstrated in clinical studies. Outcomes of interest may include office blood pressure, ambulatory blood pressure, nephroprotection, stroke, heart failure, decreased mortality, decreased emergency room or hospital admissions, and quality of life. The scope of this NCA is limited to radiofrequency- and ultrasound-based renal denervation procedures.
Pass-Through Payment
Intended Use.The Symplicity G3 Renal Denervation RF Generator when used with the Symplicity Spyral multi-electrode renal denervation catheter is intended to deliver radiofrequency (RF) energy through the wall of the renal artery to denervate the kidney from sympathetic nerve hyperactivity.Indications for useThe Symplicity Spyral Multi-Electrode Renal Denervation Catheter and the Symplicity G3 RF Generator are indicated to reduce blood pressure as an adjunctive treatment in patients withhypertension in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure.[There are also several FDA labeling contra-indications such as renal artery aneurysm, and renal artery must be in the size 3-8mm].
CMS’s stance toward the data on renal denervation (RDN) is cautiously supportive but highly conditional—best characterized as measured skepticism.
Summary of CMS’s Position:
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Not outright skeptical: CMS acknowledges the existence of RCT evidence showing that RDN can reduce systolic blood pressure modestly in certain populations, especially in the short term. Some trials, like RADIANCE II and SPYRAL HTN-OFF MED, show statistically significant reductions in ambulatory and office BP. CMS describes these trials as having “good” methodological quality.
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Not yet satisfied: Despite these promising results, CMS identifies several major evidence limitations—especially around:
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Durability of effect (long-term BP control).
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Generalizability to the Medicare population (older adults, those with comorbidities).
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Variability of outcomes between trials (e.g., REQUIRE and RADIANCE-HTN TRIO yielded null or minimal results).
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Subgroup uncertainty: Questions remain about which patient phenotypes benefit most (resistant vs. uncontrolled hypertension).
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Unknown reinnervation effects and lack of reliable intra-procedural markers of successful nerve ablation.
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Evidence Development Mandate: Accordingly, CMS is not granting unrestricted coverage, but rather placing RDN under Coverage with Evidence Development (CED). This means Medicare will pay for RDN only in CMS-approved studies, and those studies must be:
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Longitudinal (minimum 24 months).
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Include subgroup analysis (e.g., age, CKD stage, hypertension type).
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Measure hard outcomes (e.g., MI, stroke, mortality), not just BP.
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Extensive trial infrastructure required:
CMS outlines rigorous criteria for trial design, physician qualifications, and facility infrastructure, showing its desire to control for variability and bias before expanding access.
Conclusion:
CMS's stance is not hostile, but far from fully convinced. A fair summary would be:
CMS views the current RDN data as promising but incomplete. Their tone is one of conditional optimism tempered by rigorous scientific demands. Coverage is granted only through well-controlled, long-term studies under a strict CED framework.
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Are there any particularly negative points that CMS makes, that readers should be aware of?
The most hostile or strongly skeptical viewpoint in the draft NCD appears in the evidence assessment and synthesis section, particularly when CMS discusses the clinical significance and durability of the observed blood pressure reductions.
Here’s a key example of that tone:
“The efficacy of uRDN for lowering BP was mixed…although the evidence is more varied at later time points, and the evidence is limited for durability of effect.”
— [Section III.E, Assessment of Evidence]
And even more pointedly:
“In TRIO, uRDN reduced daytime ASBP statistically, but not meaningfully… At 6 months, the per-protocol analysis indicated no significant difference… These findings are statistically different but may not be clinically meaningful.”
This wording implies that:
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Positive short-term results may be misleading, and
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CMS is deeply concerned about the clinical relevance of the BP reductions, even when statistically significant.
Another hostile note is struck in CMS’s review of the REQUIRE trial, which it rates as “Poor” quality and critiques harshly:
“The authors reported the possibility of patient sampling error… poor drug adherence… and no standardization of antihypertensive medications… Blinding of clinical staff was not achieved.”
[Citations confirmed by BQ]
Finally, the overall tone is implicitly hostile in the high bar CMS sets for CED studies, demanding:
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24-month outcomes,
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composite endpoints including mortality and stroke,
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subgroup analyses by CKD, age, and adherence,
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data sharing and public reporting,
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adherence to 17 AHRQ technical criteria.
This suggests that CMS believes the current evidence does not yet meet the evidentiary threshold needed for broad coverage, and must be rebuilt under tight federal oversight.
Summary of Most Hostile Viewpoint:
CMS casts doubt on whether the modest BP reductions seen in RDN trials are clinically meaningful or durable, especially in older adults. The tone implies skepticism about the generalizability, durability, and even the value of observed effects—strongly challenging the clinical utility of RDN in its current form.
