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Baroreflex stimulation devices provide electrical stimulation of the baroreceptors in the carotid arteries by means of an implanted device. Activation of the baroreflex causes inhibition of the sympathetic nervous system, resulting in a variety of physiologic changes including slowed heart rate and decreased blood pressure. Use of baroreflex stimulation devices has therefore been proposed as a treatment for hypertension that is resistant to standard medications, as well as related conditions which are associated with high sympathetic tone.
The baroreceptors are pressure sensors contained within the walls of the carotid arteries. They are part of the autonomic nervous system that regulates basic physiologic functions such as heart rate and blood pressure. When these receptors are stretched, as occurs with increases in blood pressure, the baroreflex is activated. Activation of the baroreflex sends signals to the brain, which responds by inhibiting sympathetic nervous system output and increasing parasympathetic nervous system output. The effect of this activation is to reduce heart rate and blood pressure, thereby helping to maintain homeostasis of the circulatory system.
Hypertension is a widely prevalent condition, which is estimated to affect approximately 30% of the population in the United States and accounts for a high burden of morbidity related to strokes, ischemic heart disease, kidney disease, and peripheral arterial disease. Resistant hypertension is defined as elevated blood pressure despite treatment with at least 3 antihypertensive agents at optimal doses. Resistant hypertension is a relatively common condition. In large clinical trials of hypertension treatment, up to 20-30% of participants meet the definition for resistant hypertension, and in tertiary care hypertension clinics, the prevalence has been estimated to be 11-18%. Resistant hypertension is associated with a higher risk for adverse outcomes such as stroke, myocardial infarction (MI), heart failure, and kidney failure.
There are a number of factors that may contribute to uncontrolled hypertension, and these should be considered and addressed in all patients with hypertension before labeling a patient as resistant. These include nonadherence 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, ie, obstructive sleep apnea, to adequately control BP.
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. Nonpharmacologic interventions for resistant hypertension include modulation of the baroreflex receptor, and/or radiofrequency denervation of the renal nerves.
Baroreflex Stimulation Devices
Devices that activate the baroreflex are implantable devices that provide electrical stimulation to the baroreceptors. At least one company has developed devices for this purpose; no baroflex stimulation device has received approval or clearance from FDA.
The Rheos® Hypertension system (CVRx™, Minneapolis, MN) consists of 3 components:
CVRx™ has replaced the Rheos® system with a “second-generation” device called the Barostim neo™. The device consists of a unilateral electrode and lead that is attached to the carotid sinus and a pulse generator that is implanted subcutaneously in the chest wall. Programming is performed via radiofrequency telemetry using an external laptop computer and software.
No baroreflex activation therapy devices have received U.S. Food and Drug Administration (FDA) approval or clearance.
POLICYUse of baroreflex stimulation implanted devices is considered investigational.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY11/17/2011: Approved by Medical Policy Advisory Committee.
09/27/2012: Policy reviewed; no changes.
11/15/2013: Policy reviewed; no changes.
09/26/2014: Policy reviewed; description updated regarding uncontrolled hypertension and baroreflex stimulation devices. Policy statement unchanged.
08/21/2015: Code Reference section updated to add ICD-10 codes and ICD-9 procedure code 39.81.
SOURCE(S)Blue Cross Blue Shield Association policy # 8.01.57
This may not be a comprehensive list of procedure codes applicable to this policy.