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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. Specific devices for baroreflex stimulation have been developed, but none has received U.S. Food and Drug Administration (FDA) approval for any indication.
Baroreceptors are pressure sensors 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.
The use of baroreflex stimulation devices (also known as baroreflex activation therapy) is a potential alternative treatment for resistant hypertension and heart failure. Both hypertension and heart failure are relatively common conditions, and are initially treated with medications and lifestyle changes. A substantial portion of patients are unresponsive to conventional therapy and treating these patients is often challenging and can lead to high costs and adverse effects. As a result, there is a large unmet need for additional treatments.
Specific devices for baroreflex stimulation have been developed, but none has been approved by the U.S. Food and Drug Administration (FDA) for any indication. One device, called the Barostim neo™ (CVRx™, Minneapolis, MN, previously called the Rheos® Baroreflex Hypertension Therapy System) is approved for sale in Europe for hypertension and heart failure patients. The system 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 FDA approval or clearance.
POLICYUse of baroreflex stimulation implanted devices is considered investigational in all situations including but not limited to treatment of hypertension and heart failure.
POLICY GUIDELINESInvestigative 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.
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.
11/09/2015: Policy description revised and updated regarding devices. Policy statement updated to state that the use of baroreflex stimulation implanted devices is considered investigational in all situations including but not limited to treatment of hypertension and heart failure. Investigative definition updated in policy guidelines section.
05/26/2016: Policy number added.
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.