Renal Denervation: From 2016 to 2025 at CMS

Chat GPT compares the 2016 AHRQ TA and the 2025 CMS NCD.

Original blog here - https://www.discoveriesinhealthpolicy.com/2025/07/cms-publishes-draft-ncd-on-renal.html

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 The 2025 Draft NCD and the 2016 AHRQ Technology Assessment (TA) share a core skepticism toward renal denervation (RDN), but the 2025 NCD reflects a measurable shift toward conditional acceptance, based on newer trial evidence—albeit with strict limitations.

Here’s a side-by-side comparison of tone, content, and conclusions:

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1. Overall Tone

• 2016 AHRQ TA:
  Tone is decidedly negative. RDN is deemed investigational, and the authors express no confidence in efficacy or safety due to inconsistent results and low-quality evidence.

• 2025 Draft NCD:
  Tone is guarded but constructive. CMS acknowledges newer positive RCTs, such as SPYRAL and RADIANCE II, and proposes Coverage with Evidence Development (CED)—a step forward compared to the blanket dismissal in 2016.

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2. Evidence Base and Interpretation

• 2016 AHRQ:
  The report’s conclusion was that the SYMPICITY HTN-3 trial—a large, blinded sham-controlled RCT—showed no statistically significant benefit, undermining prior optimism. The report noted major limitations in study design, patient adherence, and confounding.

• 2025 CMS NCD:
  Acknowledges those earlier limitations but cites more recent sham-controlled RCTs showing modest but statistically significant BP reduction (e.g., ~6-8 mmHg), particularly in unmedicated populations. CMS uses GRADE and AHRQ standards but now considers the evidence of "moderate" strength in some subsets.

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3. Clinical Significance and Generalizability

• 2016 AHRQ:
  Emphasized that even if modest BP reductions occurred, there was no evidence of impact on long-term cardiovascular outcomes—stroke, MI, death.

• 2025 CMS:
  Still raises identical concerns, but instead of rejecting coverage, proposes requiring that those very endpoints be studied through CED—an important strategic pivot.

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4. Position on Coverage

• 2016 AHRQ:
  No recommendation for coverage; clearly sees the technology as experimental.

• 2025 CMS:
  Recommends narrow conditional coverage—only within well-designed clinical studies, with tight controls on patient selection, physician training, and outcomes tracking. CMS proposes a pathway to potential future coverage, which didn’t exist in 2016.

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5. View of the Evidence Trajectory

• 2016 AHRQ:
  Saw the field as stagnating or flawed, with a call for better-designed RCTs before any consideration of clinical use.

• 2025 CMS:
  Suggests the field has partially redeemed itself with improved study design and trial methodology (blinding, sham-controls, core labs), but still falls short of full validation—hence the reliance on Coverage with Evidence Development as a “middle ground.”

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Summary:

The 2016 AHRQ report is a decisive rejection of renal denervation as an effective intervention. The 2025 CMS NCD, while still cautious, represents a more nuanced and hopeful posture—acknowledging methodological improvements, positive trial data, and allowing limited Medicare coverage under rigorous research conditions. The pivot from total non-coverage to CED marks a meaningful policy evolution.

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I asked Chat GPT for a summary of likely current clinical viewpoints.

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As of 2025, the consensus professional clinical viewpoint on renal denervation (RDN) remains cautiously skeptical but increasingly curious, with selective adoption in research-savvy or interventional cardiology circles—but little mainstream uptake in routine hypertension management.

🔍 Summary of Professional Consensus in 2025:

✅ Growing but Limited Enthusiasm

• Some interventional cardiologists and hypertension specialists are cautiously optimistic, especially in referral centers and academic medical systems.

• RDN is viewed as a potential option for select patients with truly resistant hypertension (confirmed adherence, multiple drug failures).

• The 2023 FDA approvals (Medtronic’s Symplicity Spyral and ReCor’s Paradise system) sparked renewed interest, but that hasn’t yet translated into widespread use.

❌ Widespread Clinical Hesitancy

• General cardiologists and primary care physicians are often not recommending RDN. Reasons include:

  • Modest effect sizes (e.g., 5–8 mmHg reductions).

  • No evidence (yet) of reduction in hard outcomes (stroke, MI, death).

  • Concerns about patient selection, long-term durability, and cost-effectiveness.

  • Lack of real-world data beyond controlled trials.

📊 Professional Society Guidelines

• As of early 2025, ACC, AHA, and ESH (European Society of Hypertension) still list RDN as experimental or investigational, often referencing it in footnotes or sidebars for use only in clinical trials or when other therapies fail.

• No major guidelines recommend RDN as first-line or routine treatment.

🧠 The “Average” Cardiologist in 2025 Probably Thinks…

“It’s an interesting technology, but I’m not sending my patients for it yet. Show me a trial that proves it reduces stroke or heart failure in the real world—and works in older, comorbid patients—and I’ll reconsider.”

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💬 Supporting Quotes from Clinical Literature or Commentaries

(Paraphrased consensus points from editorials, panels, and opinion pieces in journals like JACC, Hypertension, NEJM):

• “RDN may offer a niche solution for a small group of patients, but it’s not a game-changer for the average hypertensive patient.”

• “Without hard outcomes, insurers and clinicians are rightly skeptical.”

• “This may be another case of elegant engineering chasing a weak clinical signal.”

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🧭 Outlook

Unless a future trial (like the one CMS may require under CED) shows cardiovascular risk reduction, RDN may remain a second- or third-tier tool, confined to specialized centers and hypertension research networks.

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