Medical policy: Baroreflex Stimulation Device

Policy number: MP 1.142

Effective date: 11/1/2026

Policy

Use of baroreflex stimulation implanted devices is considered investigational in all situations including, but not limited to, treatment of hypertension and heart failure as there is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Product variations

This policy is only applicable to certain programs and products administered by Capital Blue Cross and subject to benefit variations. Please see additional information below.

FEP PPO - Refer to Section VI of the FEP Medical Policy Manual. The FEP Medical Policy Manual can be found at: FEP Medical Policy Manual.

Description/Background

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, 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, expensive and can lead to adverse effects. As a result, there is a large unmet need for additional treatments.

Regulatory status

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.

In 2019, Barostim Neo™ was granted premarket approval (PMA P180050) and is indicated for the improvement of symptoms of heart failure (i.e., 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 (who had a recent history of Class III), have a left ventricular ejection fraction ≤ 35%, an N-terminal pro-B-type natriuretic peptide (NT-proBNP) < 1600 pg/ml, excluding patients indicated for Cardiac Resynchronization Therapy according to 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 will hasten the approval of novel therapies that target life-threatening conditions.

Rationale

Summary of evidence

For individuals who have treatment-resistant hypertension who receive baroreflex stimulation therapy, the evidence includes a randomized controlled trial (RCT) and several small uncontrolled studies. Relevant outcomes are overall survival (OS), functional outcomes, quality of life, hospitalizations, medication use, and treatment-resistant morbidity. The uncontrolled studies have reported short-term reductions in blood pressure in patients treated with baroreflex stimulation devices, as well as adverse events such as infection, hypoglossal nerve injury, and wound complications. The RCT comparing baroreflex stimulation with continued medical management met some efficacy endpoints but not others, as well as 2 of its 3 predefined safety endpoints. Additional RCTs are needed to permit conclusions on the efficacy and safety. Baroreflex stimulation for treatment-resistant hypertension is accessible only through a Humanitarian Device Exemption (HDE) for patients who previously participated in a pivotal trial. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have treatment-resistant heart failure who receive baroreflex stimulation therapy, the evidence includes 2 RCTs, a post hoc subgroup analysis of an RCT, and meta-analyses of these trials. Relevant outcomes are OS, functional outcomes, quality of life, hospitalizations, medication use, and treatment-resistant morbidity. The expedited phase of a 2019 RCT was used by the U.S. Food and Drug Administration to approve the Barostim Neo System. The trial demonstrated that the system is safe and effective for its intended use population in the short term; however, results of the extended trial are not published, and longer-term outcomes have not been determined. A 2018 RCT met all 3 efficacy endpoints but had methodologic limitations, incomplete blinding, a relatively small sample size for a common condition, and a short intervention period. Another larger RCT designed to assess the effects of the intervention on mortality, safety, function, and quality of life outcomes is underway. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Definitions

N/A

Disclaimer

Capital Blue Cross’ medical policies are used to determine coverage for specific medical technologies, procedures, equipment, and services. These medical policies do not constitute medical advice and are subject to change as permitted by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These polices are not a guarantee of coverage or payment. Payment of claims is subject to a determination regarding the member’s benefit program and eligibility on the date of service, and a determination that the services are medically necessary and appropriate. Final processing of a claim is based upon the terms of contract that applies to the members’ benefit program, including benefit limitations and exclusions. If a provider or a member has a question concerning this medical policy, please contact Capital Blue Cross’ Provider Services or Member Services.

Coding information

Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement.

Investigational; therefore, not covered

References

1. Food and Drug Administration. Humanitarian Device Exemption (HDE): Barostim Neo Legacy System. 2014 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?id=h130007. Accessed March 24, 2025.
2. Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED). 16 Aug 2019; https://www.accessdata.fda.gov/cdrh_docs/pdf18/P180050b.pdf. Accessed March 23, 2025.
3. Zile MR, Abraham WT, Lindenfeld J, et al. First granted example of novel FDA trial design under Expedited Access Pathway for premarket approval: BeAT-HF. Am Heart J. Oct 2018; 204: 139-150. PMID 30118942
4. Bisognano JD, Bakris G, Nadim MK, et al. Baroreflex activation therapy lowers blood pressure in patients with resistant hypertension: results from the double-blind, randomized, placebo-controlled rheos pivotal trial. J Am Coll Cardiol. Aug 09, 2011; 58(7): 765-73. PMID 21816315
5. Bakris GL, Nadim MK, Haller H, et al. Baroreflex activation therapy provides durable benefit in patients with resistant hypertension: results of long-term follow-up in the Rheos Pivotal Trial. J Am Soc Hypertens. Mar-Apr 2012; 6(2): 152-8. PMID 22341199
6. Heusser K, Tank J, Engeli S, et al. Carotid baroreceptor stimulation, sympathetic activity, baroreflex function, and blood pressure in hypertensive patients. Hypertension. Mar 2010; 55(3): 619-26. PMID 20101001
7. Hoppe UC, Brandt MC, Wachter R, et al. Minimally invasive system for baroreflex activation therapy chronically lowers blood pressure with pacemaker-like safety profile: results from the Barostim neo trial. J Am Soc Hypertens. Jul-Aug 2012; 6(4): 270-6. PMID 22694986
8. Scheffers IJ, Kroon AA, Schmidli J, et al. Novel baroreflex activation therapy in resistant hypertension: results of a European multi-center feasibility study. J Am Coll Cardiol. Oct 05, 2010; 56(15): 1254-8. PMID 20883933
9. Wallbach M, Lehnig LY, Schroer C, et al. Effects of Baroreflex Activation Therapy on Ambulatory Blood Pressure in Patients With Resistant Hypertension. Hypertension. Apr 2016; 67(4): 701-9. PMID 26902491
10. Cai G, Guo K, Zhang D, et al. The efficacy of baroreflex activation therapy for heart failure: A meta-analysis of randomized controlled trials. Medicine (Baltimore). Nov 06, 2020; 99(45): e22951. PMID 33157936
11. Coats AJS, Abraham WT, Zile MR, et al. Baroreflex activation therapy with the Barostim™ device in patients with heart failure with reduced ejection fraction: a patient level meta-analysis of randomized controlled trials. Eur J Heart Fail. Sep 2022; 24(9): 1665-1673. PMID 35713888
12. Zile MR, Lindenfeld J, Weaver FA, et al. Baroreflex Activation Therapy in Patients With Heart Failure With Reduced Ejection Fraction. J Am Coll Cardiol. Jul 07, 2020; 76(1): 1-13. PMID 32616150
13. GlobeNewswire. CVRx Reports Preliminary Results of the BeAT-HF Post-Market Randomized Clinical Trial.
14. Abraham WT, Zile MR, Weaver FA, et al. Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction. JACC Heart Fail. Jun 2015; 3(6): 487-496. PMID 25982108
15. Weaver FA, Abraham WT, Little WC, et al. Surgical Experience and Long-term Results of Baroreflex Activation Therapy for Heart Failure With Reduced Ejection Fraction. Semin Thorac Cardiovasc Surg. Summer 2016; 28(2): 320-328. PMID 28043438
16. Halbach M, Abraham WT, Butter C, et al. Baroreflex activation therapy for the treatment of heart failure with reduced ejection fraction in patients with and without coronary artery disease. Int J Cardiol. Sep 01, 2018; 266: 187-192. PMID 29705650
17. Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. Jun 2018; 71(6): e13-e115. PMID 29133356
18. Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. May 03 2022; 79(17): e263-e421. PMID 35379503
19. National Institute for Clinical and Care Excellence (NICE). Implanting a baroreceptor stimulation device for resistant hypertension [IPG533]. 2015
20. CVRx. CVRx Announces Expedited Access Pathway Designation by FDA for Barostim Therapy for the Treatment of Heart Failure in Order to Accelerate Access for US Patients. 2015; https://www.cvrx.com/cvrx-announces-expedited-access-pathway-designation-by-fda/. Accessed March 24, 2025.