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A.7.01.136
Radiofrequency ablation (RFA) of the renal sympathetic nerves isthought to decrease both the afferent sympathetic signals from the kidney to the brain and the efferent signals from the brain to the kidney. This procedure decreases sympathetic activation, decreases vasoconstriction, and decreases activation of the renin-angiotensin system. Radiofrequency ablation of the renal sympathetic nerves may act as a nonpharmacologic treatment for hypertension and has been proposed as a treatment option for patients with uncontrolled hypertension despite the use of anti-hypertensive medications.
Uncontrolled Hypertension
Recommendations for blood pressure generally target <130/80 mmHg, although blood pressure goal can vary (e.g., comorbidities, life-expectancy). High blood pressure, or hypertension (HTN) is estimated to affect approximately 30% of the population in the United States. It accounts for a high burden of morbidity related to stroke, ischemic heart disease, kidney disease, and peripheral arterial disease. An estimated 1 in 4 adults with hypertension have their hypertension under control, but the remaining 77% (93 million) remain uncontrolled. Uncontrolled hypertension is diagnosed when an individual's blood pressure remains above targeted levels (typically ≥140/90 mmHg) 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, sometimes it is necessary to address comorbid conditions (i.e., obstructive sleep apnea) to control blood pressure adequately.
Treatment
Radiofrequency Denervation of the Renal Sympathetic Nerves
Increased sympathetic nervous system activity has been linked to essential hypertension. Surgical sympathectomy has been shown to be effective in reducing blood pressure but is limited by the adverse events of surgery and was largely abandoned after effective medications for hypertension became available. The renal sympathetic nerves arise from the thoracic nerve roots and innervate the renal artery, the renal pelvis, and the renal parenchyma. Radiofrequency ablation (RFA) of the renal sympathetic nerves is thought to decrease both the afferent sympathetic signals from the kidney to the brain and the efferent signals from the brain to the kidney. This procedure decreases sympathetic activation, decreases vasoconstriction, and decreases activation of the renin-angiotensin system.
The procedure is performed percutaneously with access at the femoral artery. A flexible catheter is threaded into the renal artery, and a controlled energy source, most commonly low-power RF energy, is delivered to the arterial walls where the renal sympathetic nerves are located. Once adequate RF energy has been delivered to ablate the sympathetic nerves, the catheter is removed.
Ultrasound Denervation of the Renal Sympathetic Nerves
Ultrasound renal denervation (usRDN) is a minimally invasive procedure designed to treat hypertension by disrupting renal sympathetic nerves. The procedure targets the same physiological mechanism as radiofrequency ablation, aiming to decrease both afferent and efferent sympathetic signaling between the kidneys and the brain. This reduction in sympathetic activation is thought to decrease vasoconstriction and inhibit the renin-angiotensin system, ultimately leading to blood pressure reduction. The usRDN procedure is typically performed under local anesthesia with conscious sedation. Access is obtained through the femoral artery, and the catheter is advanced to the renal artery under fluoroscopic guidance. Once positioned, the catheter's balloon is inflated with cooling fluid, and ultrasound energy is delivered. Usually, 2-3 ultrasound emissions are delivered per renal artery, with the ability to treat both main renal arteries and accessory renal arteries when present.
Two renal denervation devices have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of hypertension (FDA product code: QYI):
The Paradise® Ultrasound Renal Denervation System (ReCor Medical, Inc) was approved by the FDA on November 7, 2023 and the Symplicity Spyral™ Renal Denervation System (Medtronic, Inc) was approved by the FDA on November 17, 2023. Both systems are indicated to reduce blood pressure as an adjunctive treatment in hypertension patients in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure.
No other renal denervation devices are currently FDA approved for the treatment of hypertension. Several other devices that were previously in development, such as the EnligHTN™ system (St. Jude Medical) and Vessix™ system (Boston Scientific), are no longer being marketed for this indication.
Related medical policies are –
Radiofrequency ablation of the renal sympathetic nerves is considered medically necessary for individuals whose blood pressure remains above >130/80 mmHg despite use of 3 or more antihypertensive medications from 3 classes (angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, calcium channel blockers, thiazide diuretics, and beta blockers) at maximally tolerated doses or with intolerance to antihypertensive medications whose blood pressure remains uncontrolled despite attempting lifestyle modifications (see Policy Guidelines).
Ultrasound ablation of the renal sympathetic nerves is considered medically necessary for individuals whose blood pressure remains above >130/80 mmHg despite use of 3 or more antihypertensive medications from 3 classes (angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, calcium channel blockers, thiazide diuretics, and beta blockers) at maximally tolerated doses or with intolerance to antihypertensive medications whose blood pressure remains uncontrolled despite attempting lifestyle modifications (see Policy Guidelines).
None
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Priority for renal denervation of the renal sympathetic nerves may be appropriately given to patients with higher cardiovascular risk (eg, comorbidities of coronary artery disease, diabetes, prior transient ischemic attack/cerebrovascular accident, or chronic kidney disease) who may have the greatest benefit from blood pressure reduction.
The procedure should only be performed in experienced, specialized centers with multidisciplinary hypertension teams involving experts in hypertension and percutaneous cardiovascular interventions after shared decision-making about the risks and benefits of treatment with the individual.
There is too little data to support the use of renal denervation for the following: stage 1 HTN, isolated systolic HTN, stage 4 or 5 chronic kidney disease, single kidney, kidney transplant recipients, or redo renal denervation in individuals who fail to respond to initial renal denervation.
Contraindications include: pregnancy, fibromuscular dysplasia, stented renal artery, renal artery aneurysm, significant renal artery stenosis, known kidney or secreting adrenal tumors, and unaddressed causes of secondary hypertension.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
11/15/2012: Approved by Medical Policy Advisory Committee.
10/22/2013: Policy reviewed; no changes.
10/17/2014: Policy reviewed; description updated regarding devices. Policy statement unchanged.
07/27/2015: Code Reference section updated for ICD-10.
11/09/2015: Policy description updated. Policy statement unchanged. Investigative definition updated in policy guidelines section.
05/31/2016: Policy number A.7.01.136 added.
12/30/2016: Policy description updated regarding devices. Policy statement unchanged. Code Reference section updated to add CPT codes 0338T and 0339T.
10/19/2017: Policy description updated. Policy statement unchanged.
11/09/2018: Policy description updated regarding devices. Policy statement unchanged.
11/04/2019: Policy reviewed; no changes.
10/16/2020: Policy description updated regarding devices. Policy statement unchanged.
01/10/2022: Policy description updated regarding devices. Policy statement unchanged.
02/06/2023: Policy title changed from "Radiofrequency Ablation of the Renal Sympathetic Nerves as a Treatment for Resistant Hypertension" to "Radiofrequency Ablation of the Renal Sympathetic Nerves as a Treatment for Resistant or Uncontrolled Hypertension." Policy description updated regarding devices. Policy statement updated to add uncontrolled hypertension as investigational.
03/15/2024: Policy title changed from "Radiofrequency Ablation of the Renal Sympathetic Nerves as a Treatment for Resistant or Uncontrolled Hypertension" to "Radiofrequency Ablation of the Renal Sympathetic Nerves as a Treatment for Uncontrolled Hypertension." Policy description updated to remove information regarding resistant hypertension. Added information regarding uncontrolled hypertension and devices. Policy statement updated to remove "resistant" hypertension.
12/18/2024: Code Reference section updated to add new CPT code 0935T effective 01/01/2025.
10/15/2025: Policy title changed from "Radiofrequency Ablation of the Renal Sympathetic Nerves as a Treatment for Uncontrolled Hypertension" to "Renal Denervation for Uncontrolled Hypertension." Policy description updated regarding uncontrolled hypertension, radiofrequency and ultrasound denervation of the renal sympathetic nerves, and devices. Policy section revised to add medically necessary statements regarding radiofrequency and ultrasound ablation of the renal sympathetic nerves. It previously stated: Radiofrequency ablation of the renal sympathetic nerves is considered investigational for the treatment of uncontrolled hypertension. Policy Guidelines updated regarding renal denervation of the sympathetic nerves and contraindications. Added medically necessary definition. Codes listed in Code Reference section changed from investigational to medically necessary. Added ICD-10 procedure codes 015L4ZZ, 015M4ZZ, 015N4ZZ, X051329 and ICD-10 diagnosis codes I1A.0 and I10 - I15.9.
Blue Cross Blue Shield Association policy # 7.01.136
This may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.
Code Number | Description |
CPT-4 | |
64999 | Unlisted procedure, nervous system |
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 |
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 |
0935T | Cystourethroscopy with renal pelvic sympathetic denervation, radiofrequency ablation, retrograde ureteral approach, including insertion of guide wire, selective placement of ureteral sheath(s) and multiple conformable electrodes, contrast injection(s), and fluoroscopy, bilateral (New 01/01/2025) |
HCPCS | |
ICD-10 Procedure | |
015L4ZZ | Destruction of Thoracic Sympathetic Nerve, Percutaneous Endoscopic Approach |
015M4ZZ | Destruction of Abdominal Sympathetic Nerve, Percutaneous Endoscopic Approach |
015N4ZZ | Destruction of Lumbar Sympathetic Nerve, Percutaneous Endoscopic Approach |
X051329 | Destruction of Renal Sympathetic Nerve(s) using Ultrasound Ablation, Percutaneous Approach, New Technology Group 9 (Paradise Ultrasound device) |
ICD-10 Diagnosis | |
I1A.0 | Resistant hypertension |
I10 - I15.9 | Hypertensive disease code range |
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