CurrentBlue Cross Blue Shield - IowaPolicy 07.01.100

Renal Denervation for Uncontrolled Hypertension

Defines Wellmark Blue Cross and Blue Shield's medical policy position on radiofrequency and ultrasound renal denervation for treatment of uncontrolled hypertension, summarizes evidence, regulatory status, and coding instruction (Category III codes treated as investigational unless explicitly covered).

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyRenal Denervation for Uncontrolled Hypertension

Policy CodePolicy 07.01.100

Change TypeNo material change

Effective DateJan 1, 2024

Next Review DateSep 1, 2025

Key ActionDocument baseline office and 24-hour ambulatory blood pressure, medication regimen/adherence, and renal artery anatomy/eGFR when considering renal denervation.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes identified (has_material_change = false).

1Policy verdict: investigational

2FDA-approved devices listed

4,155Pooled RCT cohort (patient-level)

3,077Global Symplicity Registry patients

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RADIANCE trials daytime SBP MD

eGFR ≥40Common renal function eligibility threshold

Coverage Summary

Policy stance: Radiofrequency and ultrasound renal denervation (RDN) are considered investigational for the treatment of uncontrolled hypertension because the evidence is insufficient to demonstrate improvement in net health outcome. FDA-approved devices referenced in the policy include the Paradise® Ultrasound Renal Denervation System (ReCor Medical) and the Symplicity Spyral™ Renal Denervation System (Medtronic) for adjunctive blood pressure reduction when lifestyle and medications are inadequate. All Category III (temporary/T) CPT codes related to RDN are considered investigational unless a Wellmark policy explicitly states coverage for a specific Category III code.

Quick reference — thresholds, status, and representative efficacy

Policy verdictInvestigational for RFA and usRDN (not covered)

Representative ambulatory SBP efficacyusRDN vs sham: ~-6.3 mmHg daytime ambulatory SBP at 2 months (RADIANCE trials)

Representative pooled long-term effectPooled 36-month between-group: 24‑h SBP -3.6 mmHg; office SBP -4.7 mmHg

Typical trial office BP entry thresholdsOffice SBP often ≥140–150 mmHg (examples: SPYRAL OFF MED 150–180 mmHg; RADIANCE-II ≥140 mmHg)

Common renal function requirementeGFR ≥40 mL/min/1.73 m² required in trials/guidance

Major adverse event rate (pooled/registry)Low AE rates; 1‑month pooled major AE ~0.4% (trial safety) and GSR composite ~11.1% over longer follow-up

Medical-Necessity Criteria

Policy Coverage Determinations

Coverage decisions for renal denervation procedures:

Radiofrequency ablation of the renal sympathetic nerves is considered investigational for the treatment of uncontrolled hypertension because the evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Ultrasound ablation of the renal sympathetic nerves is considered investigational for the treatment of uncontrolled hypertension because the evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

ALL Category III codes will be considered investigational unless the code is explicitly addressed as a covered service in a Wellmark BlueCross BlueShield Medical Coverage Policy.

Populations and Indications considered in evidence

Studies enrolled patients meeting one or more of the following eligibility frameworks:

Candidate Selection and Pre-referral Evaluation

Suggested candidate selection criteria for RDN (ultrasound or radiofrequency)

Proposed criteria described as clinically appropriate by SCAI expert responses:

Option 1 (resistant HTN): Blood pressure >130/80 mmHg despite use of 3 or more antihypertensive medications from 3 classes at maximally tolerated doses>130/80 mmHg; 3+ meds

SCAI / expert-suggested resistant hypertension selection criteria

Option 2 (intolerance to meds): Intolerance to antihypertensive medications and blood pressure remains uncontrolled despite attempting lifestyle modifications

Expert option for patients intolerant of medications

Pre-referral evaluation / prerequisites

Recommended workup and exclusions prior to RDN referral:

Provider Actions and Documentation Requirements

Billing Rule

Category III coding required when available

When available, providers must report the appropriate AMA Category III (T) code for renal denervation procedures rather than using an unlisted or deleted Category I code. All Category III codes are considered investigational by this policy unless a specific Wellmark BCBS Medical Coverage Policy explicitly states coverage for that code.

Use Category III (T) codes when one exists for the service.
Category III codes not explicitly covered by a Wellmark policy are treated as investigational.

Prior Authorization

Prior approval

Not applicable.

Coding

Category III / Temporary (T) codesCPTNot Covered

No codes listed

FDA product codes / devices mentionedmixed

QYI	FDA product code for renal denervation devices

No procedure or billing codes present in this partmixed

No codes listed

Background and Evidence Summary

Background: Renal denervation targets the renal sympathetic nerves to decrease afferent and efferent sympathetic signaling, reduce vasoconstriction, and downregulate the renin–angiotensin system. Procedures are minimally invasive and performed percutaneously via femoral artery access with catheter-based energy delivery. Two device platforms described in trials and regulatory documents are endovascular ultrasound RDN (usRDN, e.g., Paradise) and radiofrequency RDN (RFA, e.g., Symplicity Spyral), each designed to ablate renal artery wall nerves and have been evaluated in randomized, sham-controlled trials.

Study / Evidence	Key finding
SPYRAL HTN-OFF MED pilot/pivotal
Demonstrated modest reductions in 24-h and office SBP vs sham (pivotal ~-4.0 mmHg 24-h SBP and -6.6 mmHg office SBP at 3 months; posterior probability >0.999).
SPYRAL HTN-ON MED expansion
Pilot showed between-group 24-h SBP -7.4 mmHg at 6 months (significant in non-adherent subgroup); Expansion failed to meet primary 24-h SBP endpoint (0.03 mmHg difference at 6 months) though office SBP reduced ~-4.1 mmHg.
RADIANCE-HTN SOLO
usRDN superior to sham with between-group daytime ambulatory SBP difference -6.3 mmHg at 2 months; sustained BP reductions and fewer medications through follow-up.
RADIANCE II
Replicated SOLO result: between-group daytime ambulatory SBP -6.3 mmHg at 2 months (p<.001); fewer antihypertensive meds used by usRDN group.
RADIANCE-HTN TRIO
In resistant hypertension on triple therapy, daytime ambulatory SBP difference -4.5 mmHg at 2 months; durability shown in open-label follow-up to 36 months with larger long-term reductions.
RADIOSOUND-HTN
Comparative trial found usRDN superior to RFA of main renal arteries in reducing daytime ambulatory SBP at 3 months; no significant difference vs RFA main+branches.
Pooled patient-level analyses / meta-analyses
Pooled 4 RCT patient-level analysis showed sustained modest between-group reductions at 36 months: office SBP -4.7 mmHg and 24-h SBP -3.6 mmHg; meta-analyses report mixed results overall.
Global Symplicity Registry (GSR)
Registry shows BP reductions from baseline and low incidence of major adverse events; composite adverse event rate ~11.1% in broad registry cohort, but trial populations differ.

Definitions & Key Thresholds

Definitions / key terms:

- Uncontrolled hypertension: blood pressure remaining above target (typically >140/90 mmHg) despite treatment or inability to use treatments; includes resistant hypertension (BP above target despite ≥3 antihypertensive agents including a diuretic).

- Category III codes: temporary (T) CPT codes for emerging technologies; considered investigational unless explicitly covered by policy.

- usRDN: endovascular circumferential ultrasound energy delivered to the renal artery wall to ablate sympathetic nerves.

- RFA Symplicity Spyral: multielectrode radiofrequency renal denervation catheter delivering automated 4‑quadrant ablations to main, branch, and accessory renal arteries.

- ABPM (ambulatory blood pressure monitoring): out‑of‑office 24‑hour or daytime ambulatory BP measurement used to confirm uncontrolled hypertension.

- AHT: antihypertensive therapy/medications.

- eGFR: estimated glomerular filtration rate (trials commonly required ≥40 mL/min/1.73 m2).

- SBP/DBP: systolic/diastolic blood pressure.

- RDN: renal denervation, catheter‑based ablation of renal sympathetic nerves using ultrasound or radiofrequency.

- Resistant hypertension: BP >130/80 mmHg (policy/expert frameworks) or >140/90 mmHg despite ≥3 antihypertensive medications from different classes at maximally tolerated doses.

FAQs and Clinical Guidance

FAQs (Q&A):

Q: Is ultrasound RDN expected to provide a clinically meaningful improvement in net health outcome?

A: Clinical experts generally answered yes that usRDN can lower ambulatory and office BP and may be clinically meaningful for some patients, citing RADIANCE trials with between‑group daytime ambulatory SBP differences around -6.3 mmHg at 2 months and durable reductions in some long‑term follow‑ups. However, the policy concludes evidence is insufficient to demonstrate net health outcome benefit overall.

Q: Should repeat RDN be performed if initial treatment fails?

A: Experts and the policy note insufficient data to support repeat RDN; repeat procedures are uncommon and most experts consider nonresponders rather than recommending routine repeat RDN.

Revision History

2024-01-01effective

Policy effective date

2025-09-01last_review

Policy last review

2025-09-01next_reviewLatest

Next scheduled policy review

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyRenal Denervation for Uncontrolled Hypertension

Policy CodePolicy 07.01.100

Change TypeNo material change

Effective DateJan 1, 2024

Next Review DateSep 1, 2025

Key ActionDocument baseline office and 24-hour ambulatory blood pressure, medication regimen/adherence, and renal artery anatomy/eGFR when considering renal denervation.

SourceLink

On This Page

Patients with mild to moderate hypertension: office SBP ≥150 mmHg and <180 mmHg and office DBP ≥90 mmHg and mean 24-h ambulatory SBP ≥140 mmHg and <170 mmHg (SPYRAL HTN-OFF MED pilot eligibility).

SPYRAL HTN-OFF MED eligibility as reported in trials

Patients on 1-3 antihypertensive medications at ≥50% of maximal recommended dose for ≥6 weeks (SPYRAL HTN-ON MED pilot eligibility).

SPYRAL HTN-ON MED eligibility described in trials

Patients with resistant hypertension: daytime ambulatory BP ≥135/85 mmHg after single-pill triple therapy (RADIANCE-HTN TRIO).

RADIANCE-HTN TRIO eligibility

Patients with office SBP ≥140 mmHg and DBP ≥90 mmHg despite up to 2 antihypertensive medications and ambulatory SBP/DBP ≥135/85 and <170/105 after 4-week washout (RADIANCE II).

RADIANCE II eligibility

Patients with office SBP ≥150 mmHg and 24-hour ambulatory SBP ≥140 mmHg despite ≥3 antihypertensive medications (REQUIRE trial).

REQUIRE trial eligibility

Interventions evaluated

Interventions assessed in trials and registry:

Ultrasound renal denervation (usRDN): endovascular circumferential ultrasound energy applied to renal artery wall.

usRDN device/procedure description as used in trials

Radiofrequency multielectrode renal denervation (Symplicity Spyral RFA): automated 4-quadrant ablations including branch and accessory renal arteries.

Symplicity Spyral multielectrode RFA device description

Outcomes of interest

Primary and secondary outcomes measured in trials:

Change in 24-hour ambulatory systolic blood pressure (SBP).

Key short-term efficacy outcome used across trials

Change in daytime ambulatory SBP.

Daytime ambulatory SBP reported as primary in several usRDN trials

Change in office SBP and DBP.

Office BP changes reported as secondary outcomes

Medication use/intensity (number of antihypertensive medications, addition of AHT).

Medication escalation and counts tracked in trials

Long-term cardiovascular outcomes: myocardial infarction, stroke, hospitalization, mortality (follow-up ≥3 years).

Long-term outcomes considered as important but limited evidence

Adverse events: all-cause mortality, end-stage renal disease, embolic events with end-organ damage, renal artery perforation/dissection requiring intervention, vascular complications, renal artery stenosis >70%.

Safety endpoints and composite events reported in trials and registry

Study selection principles

Methodologic criteria for inclusion in the evidence review:

Comparative controlled prospective trials preferred, with RCTs prioritized.

Preferred study design per selection principles

If no RCTs, comparative observational studies (prefer prospective) considered.

Hierarchy for nonrandomized evidence

Single-arm studies used for long-term outcomes and adverse events.

Use of registries/single-arm data for safety and durability

Studies with duplicative or overlapping populations were excluded.

Avoiding double-counting of populations

Multidisciplinary discussion including lifestyle modification efforts and optimization of medication regimens

Guideline and expert consensus recommendation for team evaluation

Appropriate evaluation for secondary causes of hypertension with treatment of any identified treatable secondary cause prior to RDN

Trials and guidance required exclusion/treatment of secondary causes

Rule out white coat hypertension by confirming elevated blood pressures outside the provider's office (eg, ambulatory/home BP monitoring)use ABPM/home BP

ABPM requirement emphasized in guidance and trials

Exclude or treat significant renal artery anatomy issues (fibromuscular dysplasia, renal artery aneurysms, renal artery stenosis) prior to RDN

Anatomic exclusions used in trials and suggested by experts

Patient populations excluded or lacking evidence

Groups that were excluded from trials or for whom safety/effectiveness is unknown:

End stage renal disease (ESRD) / dialysis patients

Excluded from randomized trials

Kidney transplant recipients

Excluded or not studied in trials

Patients with renal artery stenosis

Anatomic exclusion in many trials

Fibromuscular dysplasia involving renal arteries

Anatomic exclusion and caution advised

Patients with uncontrolled diabetes (trial exclusions noted)

Some trials excluded uncontrolled diabetes

Recent major cardiovascular events (stroke or MI within 3 months)

Trials excluded recent major CV events

History of atrial fibrillation, congestive heart failure (per trial exclusions)

Excluded in many trial eligibility lists

Patients with BP >=180 mmHg (excluded in trials)>=180 mmHg excluded

Upper BP exclusion in trials

Repeat RDN

Guidance on repeat procedures:

Insufficient data to support repeat RDN; limited anecdotal reports only and most experts consider non-responders rather than recommending repeat procedures

Expert input and policy FAQ conclude repeat RDN not supported

Documentation Required

Document baseline BP, meds, and renal anatomy

Document baseline blood pressure (office and, when available, ambulatory), a current list of antihypertensive medications including doses and dates, and relevant renal anatomy (imaging reports) and eGFR prior to referral or procedure.

Baseline office BP and ambulatory BP if performed.
Current antihypertensive medication list with doses and start dates.
Renal imaging and anatomy; serum creatinine and eGFR.

Documentation Required

Track and document antihypertensive medication changes

Track and record any changes to antihypertensive medications during evaluation and follow-up. Document adherence assessments and rationale for any medication titration or discontinuation.

Record medication changes with dates and reasons.
Document adherence assessment (e.g., pharmacy fill history, patient report).

Prior Authorization

Report device and procedural details for follow-up

Report device model, manufacturer, targeted renal arterial segments (main artery vs branch), number/location of ablation sites, energy modality (ultrasound vs radiofrequency), and any device-specific follow-up recommendations in the procedure note to inform post-procedure management and surveillance.

Device type and model/manufacturer.
Procedural details: target segments, number and location of ablations, energy settings.
Recommended device-specific follow-up and surveillance plan.

Documentation Required

Multidisciplinary evaluation required prior to referral

A multidisciplinary evaluation (e.g., cardiology, hypertension specialist, nephrology, interventionalist) is recommended prior to referral for renal denervation to ensure appropriate patient selection and optimization of medical therapy.

Document consultation notes and consensus regarding candidacy.
Evidence of optimization attempts and rationale for referral.

Documentation Required

Confirm uncontrolled hypertension with ABPM

Confirm uncontrolled hypertension with ambulatory blood pressure monitoring (ABPM) when feasible to exclude white-coat effect and to document persistent elevation despite medical therapy.

Prefer daytime or 24-hour ABPM to confirm uncontrolled hypertension.
If ABPM not feasible, document reason and alternative BP assessment approach.

Documentation Required

Assess renal function (eGFR threshold)

Assess renal function prior to the procedure and document eGFR. Many protocols require consideration of renal function thresholds; document that renal function has been evaluated and any contraindications addressed.

Serum creatinine and calculated eGFR documented prior to procedure.
Document whether eGFR meets local institutional/device-specific thresholds.

Documentation Required

Document evaluation/treatment of secondary causes and exclude white coat HTN

Document evaluation for secondary causes of hypertension (e.g., primary aldosteronism, renal artery stenosis, obstructive sleep apnea) and exclude white-coat hypertension with ABPM or equivalent testing prior to considering renal denervation.

Workup and treatment for identifiable secondary causes documented.
ABPM or equivalent testing results to exclude white-coat hypertension.

Documentation Required

Demonstrate medication optimization or intolerance

Demonstrate optimization of antihypertensive therapy, or document intolerance/contraindication to standard medications. Include evidence of attempted medication titration, use of recommended combination regimens, and objective documentation of intolerance when applicable.

Evidence of medication regimen optimization (e.g., trials of guideline-directed agents and combinations).
Documented intolerances or contraindications with clinical rationale.

Prior Authorization

Refer to experienced interventional center

Refer patients to an interventional center with documented experience in renal denervation procedures and with established protocols for pre-procedure evaluation and post-procedure follow-up.

Referral to centers with documented procedural volume and expertise.
Center-specific pathways for evaluation, device selection, and follow-up.

Numeric eligibility thresholds (trial-derived)

Office BP eligibility (SPYRAL OFF-MED example)>=150 and <180 mmHg systolic; DBP >=90 mmHg

Office BP eligibility (RADIANCE-II example)>=140/90 mmHg despite up to 2 antihypertensives (with ABPM confirmation)

Daytime ambulatory BP thresholds>=135 mmHg (some trials) to >=140 mmHg for 24‑hr SBP eligibility; RADIANCE TRIO: daytime ABP >=135/85 after triple therapy

Medication requirementsRanges used: 0–2 meds (OFF MED trials), 1–3 meds at >=50% max dose (SPYRAL ON MED), or >=3 meds including diuretic for resistant HTN

eGFR requirementeGFR >=40 mL/min/1.73 m² (common trial/guideline threshold)

Other key prerequisitesConfirm uncontrolled BP with 24‑hr ABPM/home monitoring; evaluate/treat secondary causes and optimize meds before RDN