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DESCRIPTIONBaroreflex stimulation devices are used to provide baroreflex activation therapy® (BAT®) which refers to 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. 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. Surgical treatment has been tried but is not widely accepted at the present time. Besides baroreflex stimulation, another non-pharmacologic option is sympathectomy of the renal sympathetic nerves via surgery or radiofrequency ablation.
Baroreflex Activation Devices
Devices that activate the baroreflex are implantable devices that provide electrical stimulation to the baroreceptors. The Rheos® Hypertension system has been developed for this purpose. It consists of 3 components:
There are no baroreflex activation therapy devices that have received U.S. Food and Drug Administration (FDA) approval.
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.
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.