BlueCross and BlueShield of Montana Medical Policy/Codes
Baroreflex Activation Therapy (BAT) for the Treatment of Drug-Resistant Hypertension
Chapter: Therapies
Current Effective Date: April 18, 2013
Original Effective Date: April 18, 2013
Publish Date: January 18, 2013
Description

The human baroreceptor reflex (baroreflex) system is a network of natural blood pressure sensors (baroreceptors) located throughout the arteries and veins that helps regulate blood pressure in concert with the central nervous system.  For example, when pressure in the carotid arteries (the primary arteries leading from the heart to the brain) rises, carotid artery baroreceptors (located in the carotid sinus) are stimulated and transfer the pressure information to the brain through the carotid sinus nerve.  The brain then signals other parts of the body to lower systemic blood pressure by dilating blood vessels, reducing heart rate, and increasing fluid excretion through the kidneys.  However, in chronic hypertensive conditions (high blood pressure), the carotid baroreflex signal is often insufficient.  Many patients with diffuse atherosclerosis may have stiff vessels that are unable to respond to baroreflex signals.  Thus, physicians may prescribe various drugs to help maintain a safer blood pressure.  Unfortunately, some forms of hypertension do not respond well to pharmacotherapies.  Furthermore, some patients find side effects of antihypertensive drugs intolerable, even at relatively low doses.  The key role of carotid sinus baroreceptors in blood pressure regulation, therefore, makes them a potential target for the treatment of drug-resistant hypertension. 

One new treatment under study attempts to lower uncontrolled blood pressure by electrically stimulating the carotid baroreceptors.  The Rheos Baroreflex Hypertension Therapy System (CVRx, Inc., Minneapolis, MN, USA) uses a pacemaker-like implantable pulse generator, inserted subcutaneously near the clavicle (collarbone), to deliver electrical signals to baroreceptors in both the left and right carotid arteries in the neck by means of two carotid sinus leads.  Because a pressure-sensing switch that could turn on and off as needed would quickly wear out within the carotid arteries, the electrical pulse generator is always on when in the active mode.  The system's external programming components allow physicians to noninvasively regulate the intensity of electrical stimulation and program the system according to individual patient needs.  The device can deliver variable voltage to either or both carotid sinuses in a variety of modes.  As with other implantable electronic devices, the Rheos system would likely require surgical replacement of the implantable pulse generator when the device's batteries have been depleted.  Vascular surgeons, who are the most experienced at operating on carotid arteries, implant the device during a minimally invasive procedure.  CVRx is currently conducting clinical trials of the Rheos system under investigational device exemption status from the U.S. Food and Drug Administration.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coverage

Blue Cross and Blue Shield of Montana (BCBSMT) considers Baroreflex Activation Therapy (BAT) ® for the treatment of drug-resistant hypertension, using any carotid sinus stimulation device (e.g., Rheos Baroreflex Hypertension Therapy System®), experimental, investigational and unproven.

Rationale

Baroreflex Activation Therapy (BAT) using the Rheos Baroreflex Hypertension Therapy System was evaluated in a prospective double-blind pivotal phase III trial, with 265 patients who were randomized on a 2:1 basis from 49 sites.  All patients had to have systolic BP of >160 mm Hg and/or diastolic BP >80 mm Hg, with 24-hour ambulatory BP monitoring (ABPM) readings of >135 mm HG and at least one month of maximally tolerated therapy with at least three appropriate antihypertensive medications, including a diuretic.  The patients had a mean body-mass index (BMI) of 32 to 33, and they were taking an average of 5.2 antihypertensive therapies.

All patients were surgically implanted with the device, with group A, consisting of 181 patients, having the device turned on after one month.  The remainder (n=84), group B, had the device implanted, but it was turned off for the first seven months.  There were five co-primary end points: the short-term acute response six months after the device was turned on; the long-term sustained response; short-term procedural adverse events; short-term hypertension-therapy adverse events; and long-term device adverse events.

The first end point, short-term acute response, failed to reach significance in the on-treatment group, with 65% of patients in that group achieving the goal, a 10-mm-Hg reduction in systolic BP at six months, compared with 45% in the off-treatment group.  

End point two, the long-term sustained response, did reach significance.  However, only those in group A, the patients in whom the device was turned on a month after implantation, and not those in group B—in whom the device was turned on six months later—were assessed in this end point. 

There were a number of adverse events relating to the surgical procedure to implant the Rheos system, and as a result, end-point three—short-term procedural adverse events—was not met. Overall, 75% of patients were free of procedural adverse events at 30 days, but the prespecified figure for this was 82%.  In terms of adverse procedural events, 4.4% of patients had permanent nerve injury, 4.8% had transient nerve injury, 4.4% had general surgical complications, and 2.6% had respiratory complications.  There were 76% of all adverse events fully resolved.  The other two end points—long-term device safety and short-term therapy safety—were met.  Study conclusions note that the weight of overall evidence suggests long-term efficacy of BAT to reduce BP in resistant hypertension, and that the data justifies further development.

Summary:

Although results from the Rheos pivotal phase III trial are promising, additional studies are necessary to justify this new treatment modality.  In addition, so far BAT has not been compared to drug therapy alone (i.e., without any device implantation) for controlling severe hypertension in clinical trials.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

401.0, 401.1, 401.9

ICD-10 Codes
03HK0MZ, 03HK3MZ, 03HK4MZ, 03HL0MZ, 03HL3MZ, 03HL4MZ, 0J60MZ, 0J63MZ
Procedural Codes: 0266T, 0267T, 0268T, 0269T, 0270T, 0271T, 0272T, 0273T
References
  1. News release: CVRx, Inc., receives IDE approval for Rheos Baroreflex Hypertension Therapy System pivotal trial. Minneapolis (MN): CVRx, Inc.; 2006 Oct 16. 2 p.  www.cvrx.com .
  2. CVRx, Inc. ACC 2011 BAT HTN Pivotal Trial late-breaker presentation.  www.cvrx.com .  Accessed May 31, 2011. 
  3. ECRI Institute: Baroreflex stimulation for severe, drug-resistant hypertension.  5/02/2011. www.ecri.org   Accessed May 2011.
History
January 2013

New 2013 BCBSMT medical  Policy.  Considered Investigational.

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Baroreflex Activation Therapy (BAT) for the Treatment of Drug-Resistant Hypertension