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Renal Denervation for Uncontrolled Hypertension Form

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Renal Denervation for Uncontrolled Hypertension

Indications

(1) Does the request meet this criterion: Refer to the criteria under the Policy section in this medical policy. Medicaid – BeHealthy:? 
(2) Does the request meet this criterion: Refer to the criteria under the Policy section in this medical policy. Medicare:? 
(3) Does the request meet this criterion: HNE follows National Coverage Analysis (NCA) (CAG-00470N) for Renal Denervation (RDN) for Uncontrolled Hypertension. NCA - Renal Denervation for Uncontrolled Hypertension (CAG-00470N) 3 Policy I. Renal Denervation (Ablation of the renal sympathetic nerves) using radiofrequency or ultrasound is? 
(4) Does the request meet this criterion: The renal denervation (RDN) procedure is done utilizing an FDA approved device; AND? 
(5) Does the request meet this criterion: The member is 18 years or older; AND? 

YesNoN/A
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Effective Date

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Last Reviewed

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Original Document

  Reference



1 Renal Denervation for Uncontrolled Hypertension Medical Policy New Effective: February 1st, 2026 Policy Number: UM1067POL Approval Date: 11/11/2025 Line(s) of Business: Commercial
Medicare Advantage
Medicaid (BeHealthy) Description Hypertension Hypertension (High Blood Pressure) is estimated to affect approximately 30% of the population in the U.S (CDC, Sekkarie et al. 2024). An estimated 1 in 4 adults with hypertension have their hypertension under control, but the remaining 77% (93 million) remain uncontrolled (CDC, 2024). Hypertension is a major modifiable risk factor associated with multiple morbidities and mortality. It effects the cardiovascular and renal systems as well as contributes to complications of other diseases (Sarathy et al., 2021). The sympathetic nervous system is activated in stressful or emergency situations and often referred to as the fight-or-flight response. The kidneys play a major role in the response by increasing secretion of renin, to activate a chemical chain reaction that changes the hemodynamic system of the body and provide the protective physiological response needed for a person to react. The systemic effects include arterial blood vessel constriction, increased heart rate, dilated pupils and elevation of blood pressure (Sarathy et al., 2021). Sympathetic hyperactivity mediated resistant hypertension has been associated with multiple conditions, including but not limited to stroke, obstructive sleep apnea, metabolic syndrome, myocardial hypertrophy and heart failure, and cardiac dysrhythmias (Sarathy et al., 2021; Bohm et al., 2014). Renal injury or hypoxia can further result in systemic and renal sympathetic activity. Renal nerves play a critical role in regulating blood pressure and fluid volume, and their dysfunction is closely related with cardiovascular diseases. Renal nerves are composed of sympathetic efferent and sensory afferent nerves. Activation of the efferent renal sympathetic nerves induces renin secretion, sodium absorption, and increased renal vascular resistance, which lead to increased blood pressure and fluid retention. Afferent renal sensory nerves, which are densely innervated in the renal pelvic wall, project to the hypothalamic paraventricular nucleus in the brain to modulate sympathetic outflow to the periphery, including the heart, kidneys, and arterioles. The effects of renal denervation on the cardiovascular system are mediated by both efferent denervation and afferent denervation. (Katsurada et al., 2021).

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Uncontrolled Hypertension

Uncontrolled hypertension is diagnosed when an individual's blood pressure remains above targeted levels, defined by systolic BP (SBP) ≥140 mm Hg or diastolic BP (DBP) ≥90 mm Hg. It can happen when a patient either is not using, or unable to use, treatments to control blood pressure or when hypertension persists despite antihypertensive therapies. The definition of uncontrolled hypertension is inclusive of resistant hypertension in which blood pressure remains above the targeted range despite the use of 3 or more antihypertensive medications, including a diuretic, with complementary mechanisms of action. A number of factors may contribute to uncontrolled hypertension, including non-adherence to medications, excessive salt intake, inadequate doses of medications, excess alcohol intake, volume overload, drug-induced hypertension, and other forms of secondary hypertension. Also, it is sometimes necessary to address comorbid conditions (i.e., obstructive sleep apnea) to control blood pressure adequately.

Renal denervation (RDN)

RDN is a relatively new approach to treating hypertension that involves a controlled damage to the sympathetic innervation within the renal arteries. There are two main types of RDN: radiofrequency ablation (Medtronic Symplicity Spyral) and ultrasound ablation (Recor Paradise Ultrasound). A third modality, alcohol-mediated RDN (i.e. the Peregrine System) is currently being studied but has not yet received FDA approval.

Radiofrequency ablation (RFA) RDN uses a catheter to position electrodes (typically 4 spaced approximately 6mm apart in a spiral sequence) that generate heat using medium frequency alternating current. The heat generated is well tolerated by the wall of the renal artery, but is toxic to the nerves surrounding the artery that are exposed to the heat energy field. The energy field ranges as far as 7mm from the lumen of the artery. (Rey-García et al, 2023).

Ultrasound RDN deliver a series of ultrasound-emitting sources (typically 4) that are mounted on a catheter with an inflatable balloon system that allows irrigation of the portion of the catheter in contact with the wall of the renal artery with a solution that maintains a cooler temperature in the lumen than in the perivascular space. (Rey- García et al, 2023)

 Line of Business

Commercial:

• Refer to the criteria under the Policy section in this medical policy.

Medicaid – BeHealthy:

• Refer to the criteria under the Policy section in this medical policy.

Medicare:

• HNE follows National Coverage Analysis (NCA) (CAG-00470N) for Renal Denervation (RDN) for Uncontrolled Hypertension.

NCA - Renal Denervation for Uncontrolled Hypertension (CAG-00470N)

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Policy

I. Renal Denervation (Ablation of the renal sympathetic nerves) using radiofrequency or ultrasound is considered MEDICALLY NECESSARY for the treatment of resistant hypertension when ALL the following criteria are met:

  1. The renal denervation (RDN) procedure is done utilizing an FDA approved device; AND
  2. The member is 18 years or older; AND
  3. The member has been diagnosed with resistant hypertension (SBP ≥140 mmHg OR DBP ≥90 mmHg) that remains uncontrolled despite 3 blood pressure-lowering medications from different classes at maximally tolerated doses, including a thiazide diuretic; AND
  4. Documented evidence or attestation of medication compliance from the treating physician, OR documentation that the member is not able to meet this criterion due to medication intolerance or contraindications; AND
  5. Uncontrolled hypertension is confirmed by 24-hour ambulatory blood pressure readings or serial home blood pressure readings; AND
  6. Secondary causes of hypertension (e.g. primary aldosteronism, pheochromocytoma, primary kidney disease, Cushing’s syndrome, sleep apnea) have been ruled out; AND
  7. Member has eGFR > 40 ml/min/1.73m2.
  8. The primary clinicians must manage the patient for a minimum of six months before referral for renal denervation.

  9. Member does not have ANY condition listed under criteria II.

    II. RDN with radiofrequency or ultrasound ablation (of the renal sympathetic nerves) is considered NOT MEDICALLY NECESSARY if ANY of the following conditions are present:

  10. Renal artery fibromuscular dysplasia,
  11. Stented renal artery (< 3 months prior to radiofrequency ablation procedure),
  12. Renal artery aneurysm,
  13. Actively pregnant or breastfeeding,
  14. Presence of abnormal kidney (or secreting adrenal) tumors,
  15. Known iliac/femoral artery stenosis precluding insertion of the catheter,
  16. Significant renal artery stenosis (> 50%),

  17. Active infection within previous 7 days prior to procedure.

    III. RDN is a one-time procedure to be done with either radiofrequency or ultrasound, hence repeat therapy is considered NOT MEDICALLY NECESSARY.

    IV. RDN using alcohol-mediated RDN (e.g., Peregrine System™) and Verve Transurethral Renal Pelvic Denervation System (Verve Medical Inc.) are considered EXPERIMENTAL and INVESTIGATIONAL.

    Coding Guidance

    Applicable ICD10 Codes that may support medical necessity:
    • I10 Essential (primary) hypertension
    • I15.0 Renovascular hypertension
    • I16.0 Hypertensive urgency
    • I16.1 Hypertensive emergency
    • I16.9 Hypertensive crisis, unspecified
    • I1A.0 Resistant hypertension

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Code
Description
PA 0338T Transcatheter renal sympathetic denervation, percutaneous approach including arterial puncture, selective catheter placement(s) renal artery(ies), fluoroscopy, contrast injection(s), intraprocedural roadmapping and radiological supervision and interpretation, including pressure gradient measurements, flush aortogram and diagnostic renal angiography when performed; unilateral Yes 0339T Transcatheter renal sympathetic denervation, percutaneous approach including arterial puncture, selective catheter placement(s) renal artery(ies), fluoroscopy, contrast injection(s), intraprocedural roadmapping and radiological supervision and interpretation, including pressure gradient measurements, flush aortogram and diagnostic renal angiography when performed; bilateral Yes

CPT® Copyright 2025 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Note: CPT/HCPCS codes are included for informational purposes and may not be all inclusive. Inclusion or exclusion of a CPT/HCPCS code(s) does not signify or imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member’s specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee of payment. Other policies and coverage determination guidelines may apply.

References

  1. National Coverage Analysis (NCA) for Renal Denervation for Uncontrolled Hypertension. NCA - Renal Denervation for Uncontrolled Hypertension (CAG-00470N)
  2. Ahlia Sekkarie, PhD; Jing Fang, MD; Donald Hayes, MD; Fleetwood Loustalot, PhD. Prevalence of Self- Reported Hypertension and Antihypertensive Medication Use Among Adults — United States, 2017– 2021, Weekly / March 7, 2024 / 73(9);191–198. https://www.cdc.gov/mmwr/volumes/73/wr/mm7309a1.htm#contribAff

  3. Health and Economic Benefits of High Blood Pressure Interventions. https://www.cdc.gov/nccdphp/priorities/high-blood-pressure.html#:~:text=Quick%20facts,1

  4. Azeez GA, Thirunagari M, Fatima N, et al. The Efficacy of Renal Denervation in Treating Resistant Hypertension: A Systematic Review. Cureus. 2024;16(8):e67007. Published 2024 Aug 16. doi:10.7759/cureus.67007

  5. Azizi M, et al. RADIANCE II Investigators and Collaborators. Endovascular Ultrasound Renal Denervation to Treat Hypertension: The RADIANCE II Randomized Clinical Trial. JAMA. 2023 Feb 28;329(8):651-661. doi: 10.1001/jama.2023.0713. Erratum in: JAMA. 2023 Jun 13;329(22):1989. doi: 10.1001/jama.2023.8136.

  6. Azizi M, et al. RADIANCE-HTN Investigators. Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicenter, international, single-blind, randomized, sham- controlled trial. Lancet. 2018 Jun 9;391(10137):2335-2345. doi: 10.1016/S0140-6736(18)31082-1. Epub 2018 May 23. Erratum in: Lancet. 2018 Sep 8;392(10150):820. doi: 10.1016/S0140- 6736(18)32058-0.

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  1. Azizi M, et al. Six-Month Results of Treatment-Blinded Medication Titration for Hypertension Control After Randomization to Endovascular Ultrasound Renal Denervation or a Sham Procedure in the RADIANCE-HTN SOLO Trial. Circulation. 2019 May 28;139(22):2542-2553. doi:10.1161/CIRCULATIONAHA.119.040451. Epub 2019 Mar 17.

  2. Barbato E, Azizi M, Schmieder RE, et al. Renal denervation in the management of hypertension in adults. A clinical consensus statement of the ESC Council on Hypertension and the European Association of Percutaneous Cardiovascular Interventions (EAPCI)[published correction appears in Eur Heart J. 2023 Jul14;44(27):2439. doi: 10.1093/eurheartj/ehad321]. Eur Heart J. 2023;44(15):1313-1330. doi:10.1093/eurheartj/ehad054.

  3. Böhm M, et al. Ambulatory heart rate reduction after catheter-based renal denervation in hypertensive patients not receiving anti-hypertensive medications: data from SPYRAL HTN-OFF MED, a randomized, sham-controlled, proof-of-concept trial. Eur Heart J. 2019 Mar 1;40(9):743-751. doi:10.1093/eurheartj/ehy871.

  4. Böhm M, et al. Effect of Heart Rate on the Outcome of Renal Denervation in Patients With Uncontrolled Hypertension. J Am Coll Cardiol. 2021 Sep 7;78(10):1028-1038. doi: 10.1016/j.jacc.2021.06.044.

  5. Böhm M, et al; SPYRAL HTN-OFF MED Pivotal Investigators. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicenter, randomised, sham-controlled trial. Lancet. 2020 May 2;395(10234):1444-1451. doi: 10.1016/S0140- 6736(20)30554-7. Epub 2020 Mar 29.

  6. Chaudhry HS, Shehzad D, Shehzad M, etal. The Evolution of Renal Denervation for the Treatment of Hypertension: Insights from Trials and Prospects for Clinical Practice. S D Med. 2024;77(8):365-371.

  7. Chowdhury EK, Reid CM, Zomer E, Kelly DJ, Liew D. Cost-Effectiveness of Renal Denervation Therapy for Treatment-Resistant Hypertension: A Best Case Scenario. Am J Hypertens. 2018;31(10):1156-1163. doi:10.1093/ajh/hpy108.

  8. Cluett JL, Blazek O, Brown AL, et al. Renal Denervation for the Treatment of Hypertension: A Scientific Statement From the American Heart Association. Hypertension. Published online August 5, 2024. doi:10.1161/HYP.0000000000000240.

  9. 12.Fengler K, et al. A Three-Arm Randomized Trial of Different Renal Denervation Devices and Techniques in Patients With Resistant Hypertension(RADIOSOUND-HTN). Circulation. 2019 Jan 29;139(5):590-600.

  10. Fengler K, et al. 6-and 12-Month Follow-UpFrom a Randomized Clinical Trial of Ultrasound vs Radiofrequency Renal Denervation (RADIOSOUND-HTN).JACC CardiovascInterv. 2023 Feb 13;16(3):367-

  12. Hayes, Inc. Clinical Research Response. Symplicity Spyral Renal Denervation System (Medtronic). Hayes, Inc. December 8, 2023.

  13. Hayes, Inc. Evolving Evidence Review. ParadiseUltrasound Renal Denervation System (ReCor MedicalInc.) for Resistant Hypertension. Hayes, Inc. April 17, 2024.

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  1. Kandzari DE, Townsend RR, Bakris G, et al. Renal denervation in hypertension patients: Proceedings from an expert consensus roundtable cosponsored by SCAI and NKF. Catheter Cardiovasc Interv. 2021;98(3):416-426. doi:10.1002/ccd.29884.

  2. Kandzari DE, et al; SPYRAL HTN-ON MED Trial Investigators. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet. 2018 Jun 9;391(10137):2346-2355. doi: 10.1016/S0140- 6736(18)30951-6. Epub 2018 May 23.

  3. Kario K, et al. Long-term reduction in morning and nighttime blood pressure after renal denervation: 36- month results from SPYRAL HTN-ON MED trial. Hypertens Res. 2023 Jan;46(1):280-288. doi: 10.1038/s41440-022-01042-8. Epub 2022 Oct 15.

  4. Kario K, et al. Catheter-based ultrasound renal denervation in patients with resistant hypertension: the randomized, controlled REQUIRE trial. Hypertens Res. 2022 Feb;45(2):221-231. doi: 10.1038/s41440-021- 00754-7. Epub 2021 Oct 15.

  5. Katsurada K, Shinohara K, Aoki J, Nanto S, Kario K. Renal denervation: basic and clinical evidence. Hypertens Res. 2022 Feb;45(2):198-209. doi: 10.1038/s41440-021-00827-7. Epub 2021 Dec 17.

  6. Kreutz R, Brunström M, Burnier M, et al. 2024 European Society of Hypertension clinical practice guidelines for the management of arterial hypertension. Eur J Intern Med. 2024;126:1-15. doi:10.1016/j.ejim.2024.05.033.

  7. Lee CK, et al. Efficacy and Safety of Renal Denervation for Patients with Uncontrolled Hypertension in Taiwan: 3-Year Results From the Global SYMPLICITY Registry-Taiwan (GSR-Taiwan). Acta Cardiol Sin. 2019 Nov;35(6):618-626. doi: 10.6515/ACS.201911_35(6).20190826A.

  8. Lobo MD, Sharp ASP, Kapil V, et al. Joint UK societies' 2019 consensus statement on renal denervation. Heart. 2019;105(19):1456-1463. doi:10.1136/heartjnl-2019-315098.

  9. Mahfoud F, et al. Effects of renal denervation on kidney function and long-term outcomes: 3-year follow- up from the Global SYMPLICITY Registry. Eur Heart J. 2019 Nov 1;40(42):3474-3482. doi: 10.1093/eurheartj/ehz118.

  10. Maini AS, Maini M, Addo T, et al. The Current State and Future of Renal Denervation: A Review. Trends Cardiovasc Med. Published online August 27, 2024. doi:10.1016/j.tcm.2024.08.005.

  11. McEvoy JW, McCarthy CP, Bruno RM, et al. 2024 ESC Guidelines for the management of elevated blood pressure and hypertension. Eur Heart J. Published online August 30, 2024. doi:10.1093/eurheartj/ehae178.

  12. Mufarrih SH, Qureshi NQ, Khan MS, et al. Randomized Trials of Renal Denervation for Uncontrolled Hypertension: An Updated Meta-Analysis. J Am Heart Assoc. 2024;13(16):e034910. doi:10.1161/JAHA.124.034910.

  13. National Institute for Health and Care Excellence. Percutaneous transluminal renal Sympathetic denervation for resistant hypertension. Interventional procedures guidance IPG754. March 1, 2023.

  14. Rey-García J, Townsend RR. Renal Denervation: A Review. Am J Kidney Dis. 2022 Oct;80(4):527-535. doi: 10.1053/j.ajkd.2022.03.015. Epub 2022 May 20. Erratum in: Am J Kidney Dis. 2023 Jan;81(1):125. doi: 10.1053/j.ajkd.2022.10.003.

7

  1. Sharp ASP, Cao KN, Esler MD, et al. Cost-effectiveness of catheter-based radiofrequency renal denervation for the treatment of uncontrolled hypertension: an analysis for the UK based on recent clinical evidence. Eur Heart J Qual Care Clin Outcomes. Published online January 9, 2024. doi:10.1093/ehjqcco/qcae001.

  2. Swaminathan RV, East CA, Feldman DN, et al. SCAI Position Statement on Renal Denervation for Hypertension: Patient Selection, Operator Competence, Training and Techniques, and Organizational Recommendations. J Soc Cardiovasc Angiogr Interv. 2023;2(6Part A):101121. Published 2023 Aug 21. doi:10.1016/j.jscai.2023.101121.

  3. Taylor RS, Bentley A, Metcalfe K, et al. Cost Effectiveness of Endovascular Ultrasound Renal Denervation in Patients with Resistant Hypertension [published correction appears in Pharmacoecon Open. 2024 Jul;8(4):641. doi: 10.1007/s41669-024-00485-8]. Pharmacoecon Open. 2024;8(4):525-537. doi:10.1007/s41669-024-00472-z.

  4. Townsend RR, et al; SPYRAL HTN-OFF MED trial investigators*. Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN- OFF MED): a randomised, sham-controlled, proof-of-concept trial. Lancet. 2017 Nov 11;390(10108):2160-

  5. doi: 10.1016/S0140-6736(17)32281-X. Epub 2017 Aug 28.

  6. Vukadinović D, Lauder L, Kandzari DE, et al. Effects of Catheter-Based Renal Denervation in Hypertension: A Systematic Review and Meta-Analysis. Circulation. Published online October 2, 2024. doi:10.1161/CIRCULATIONAHA.124.069709.

  7. Weber T, et al. Twenty-Four-Hour Pulsatile Hemodynamics Predict Brachial Blood Pressure Response to Renal Denervation in the SPYRAL HTN-OFF MED Trial. Hypertension. 2022 Jul;79(7):1506-1514. doi: 10.1161/HYPERTENSIONAHA.121.18641. Epub 2022 May 18.

  8. Zeng W, Tomlinson B. Options for patients with out-of-control blood pressure: after all avenues have been exhausted. Expert Rev Cardiovasc Ther. Published online September 11, 2024. doi:10.1080/14779072.2024.2401875.

    Policy Implementation

    Approved by the Medical and Pharmacy Policy Committee

    Kate McIntosh MD MBA

    Chief Medical Officer

    Saad Usmani MD MBA

    Medical Director

    Date Update 09/2025 New Policy.

8

Medical Criteria Disclaimer

Property of Health New England. All rights reserved. The treating physician or primary care provider must submit to Health New England the clinical evidence that the patient meets the criteria for the treatment, testing or surgical procedure. Without this documentation and information, Health New England will not be able to properly review the request for prior authorization. The clinical review criteria reflect how Health New England determines whether certain services or supplies are medically necessary. Health New England established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors).
Health New England expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by Health New England, as some programs exclude coverage for services or supplies that Health New England considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at time of publication. Health New England has adopted the herein policy in providing management, administrative and other services to its Health Plan.

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