Baroreflex Stimulation Devices

POLICY NUMBER

A.8.01.57

DESCRIPTION

Baroreflex stimulation devices provide electrical stimulation of the baroreceptors in the carotid arteries using an implanted device.Activation of the baroreflex inhibits the sympathetic nervous system, resulting in various physiologic changes, including slowed heart rate and lower blood pressure.

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, which occurs with increases in blood pressure, the baroreflex is activated. Activation of the baroreflex signals 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 heart failure. Heart failure is a relatively common condition, and is initially treated with medications and lifestyle changes. A substantial portion of patients are unresponsive to conventional therapy and treating these patients is often challenging, expensive, and can lead to adverse events. As a result, there is a large unmet need for additional treatments.

In 2014, the Barostim Neo™ Legacy System received a humanitarian device exemption from the U.S. Food and Drug Administration (FDA) for use in patients with treatment-resistant hypertension who received Rheos® Carotid Sinus leads as part of the Rheos pivotal trial and were considered responders in that trial. The Rheos device did not receive FDA approved, and no additional patients will be accrued under the humanitarian device exemption. Barostim is no longer marketed for individuals with treatment-resistant hypertension, and this indication is not presented in this policy.

In 2019, Barostim Neo was granted premarket approval (PMA P180050) and is indicated for the improvement of symptoms of heart failure (ie, quality of life, six-minute hall walk, and functional status) for patients who remain symptomatic despite treatment with guideline-directed medical therapy, are New York Heart Association (NYHA) Class III or Class II (with a recent history of Class III), and have a left ventricular ejection fraction ≤35% and a N-terminal pro-B-type natriuretic peptide (NT-proBNP) <1600 pg/ml, excluding patients indicated for Cardiac Resynchronization Therapy (CRT) according to the American Heart Association/American College of Cardiology/European Society of Cardiology guidelines.

It was the first device to be granted approval via the Expedited Access Pathway. The Expedited Access Pathway was a mechanism used to hasten the approval of novel therapies that target life-threatening conditions. The Expedited Access Pathway was subsequently replaced by the Breakthrough Devices Program.

In 2023, following the extended phase of the BEAT-HF study, Barostim Neo's indication was expanded for patients who are NYHA Class III or Class II (who had a recent history of Class III) despite treatment with guideline-directed medical therapies (medications and devices), have a left ventricular ejection fraction of ≤35%, and a NT-proBNP <1600 pg/ml.

POLICY

Baroreflex stimulation therapy with a device approved by the U.S. FDA is considered investigational for individuals with heart failure despite the use of maximally tolerated guideline-directed medical and device therapy (see Policy Guidelines section).

Baroreflex stimulation therapy is investigational for all other indications.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

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 HISTORY

11/17/2011: 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 A.8.01.57 added.

06/14/2017: Policy description updated regarding devices. Policy statement unchanged.

06/19/2018: Policy reviewed; no changes.

06/10/2019: Policy reviewed; no changes.

07/09/2020: Policy description updated regarding devices. Policy statement unchanged.

12/22/2020: Code Reference section updated to add new HCPCS code C1825, effective 01/01/2021.

08/24/2021: Policy description updated. Policy statement unchanged.

06/22/2022: Policy reviewed; no changes.

07/17/2023: Policy description updated. Policy statement unchanged.

05/22/2024: Policy reviewed; no changes.

09/19/2025: Policy description updated regarding devices. Policy statement revised to remove the indication for baroreflex stimulation therapy for individuals with treatment-resistant hypertension as the device is no longer marketed for this indication. It previously stated: Use of baroreflex stimulation implanted devices is considered investigational in all situations, including but not limited to treatment of hypertension and heart failure.

01/01/2026: Code Reference section updated to add new CPT codes 64654 - 64659, 93145, and 93146.

SOURCE(S)

Blue Cross Blue Shield Association policy # 8.01.57

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.       

Investigational Codes

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