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DESCRIPTIONRadiofrequency 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 decreases sympathetic activation, decreases vasoconstriction, and decreases activation of the reninangiotensin system. RFA of the renal sympathetic nerves may act as a non-pharmacologic treatment for hypertension and has been proposed as a treatment option for patients with resistant hypertension.
A number of factors may contribute to uncontrolled hypertension, and these should be considered and addressed in all patients with hypertension before labeling a patient resistant. These include 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 adequately control blood pressure.
Treatment for resistant hypertension is mainly intensified drug therapy, sometimes with the use of non-traditional antihypertensive medications such as spironolactone and/or minoxidil. However, control of resistant hypertension with additional medications is often challenging and can lead to high costs and frequent adverse effects of treatment. As a result, there is a large unmet need for additional treatments that can control resistant hypertension. Non-pharmacologic interventions for resistant hypertension include modulation of the baroreflex receptor, and/or radiofrequency (RF) denervation of the renal nerves.
Radiofrequency Denervation of the Renal Sympathetic Nerves
The procedure is performed percutaneously with access at the femoral artery. A flexible catheter is threaded into the renal artery and 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.
No RFA devices have been approved by the U.S. Food and Drug Administration (FDA) for ablation of the renal sympathetic nerves as a treatment for hypertension. Several devices have been developed for this purpose and are in various stages of application for FDA approval.
Other RFA catheters (eg, Thermocouple Catheter™ [Biosense Webster, Diamond Bar, CA]) used for other types of ablation procedures (eg, cardiac electrophysiology procedures) have been used off-label for RFA of the renal arteries.
POLICYRadiofrequency ablation of the renal sympathetic nerves is considered investigational for the treatment of resistant hypertension.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
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.
POLICY HISTORY11/15/2012: 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. Investigtive 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.
SOURCE(S)Blue Cross Blue Shield Association policy # 7.01.136
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.