Description of Procedure or Service

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

Background

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.

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 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. The Rheos device did not recieve FDA approval, and no additional patients will be accrued under the humanitarian device exemption. Barostim is no longer marketed for individuals with treatment-resistant hypertension.

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 NYHA Class III or Class II (with a recent   history of Class III), and have a left ventricular ejection fraction ≤ 35%, a NT-proBNP < 1600pg/ml and excluding patients indicated for Cardiac Resynchronization Therapy (CRT) 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 (EAP). EAP 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.

Related Policies

Facility Billing Requirements

***Note: This Medical Policy is complex and technical. For questions concerning the technical language and/or specific clinical indications for its use, please consult your physician.

Policy

Baroreflex stimulation devices are considered investigational for all applications. BCBSNC does not provide coverage for investigational services or procedures. 

Benefits Application

This medical policy relates only to the services or supplies described herein. Please refer to the Member's Benefit Booklet for availability of benefits. Member's benefits may vary according to benefit design; therefore member benefit language should be reviewed before applying the terms of this medical policy.

When Baroreflex Stimulation Devices are covered

Not Applicable.

When Baroreflex Stimulation Devices are not covered

Baroreflex stimulation devices are considered investigational for all applications. 

Policy Guidelines

The evidence for individuals with treatment-resistant heart failure who receive baroreflex stimulation therapy includes 2 RCTs and a post hoc subgroup analysis of an RCT, a non-randomized controlled trial, and meta-analyses of these trials. Relevant outcomes are overall survival, quality of life, functional outcomes, 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 met its primary efficacy endpoints of improving quality of life (QoL), 6 minute hall walking distance (6MHWD), and NT-proBNP levels in the short term. In the extended phase of the trial, no statistically significant benefit for the primary efficacy composite outcome of cardiovascular mortality and heart failure morbidity was observed. The pre-specified safety outcome and secondary outcomes in the extended phase were met. QoL, NYHA class, and 6MHWD showed a statistically and clinically significant advantage for the baroreflex stimulation plus medical therapy group through up to 2 years post-treatment. 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. The non-randomized study found that baroreflex stimulation was associated with improvements in left ventricular ejection fraction (LVEF), New York Heart Association (NYHA) class, QoL, and NT-proBNP levels relative to guideline-directed medical therapy (GDMT) at 12 months post-intervention. Overall, baroreflex stimulation demonstrates a favorable safety profile and produces modest improvements in functional capacity and quality of life; however, it has not shown significant reductions in either heart failure morbidity or mortality compared to guideline-directed medical therapy. Existing trials suffer from methodological limitations, highlighting the need for a rigorously designed sham-controlled study. The evidence is insufficient to determine that the technology results in an improvement in net health outcome.

Billing/Coding/Physician Documentation Information

This policy may apply to the following codes. Inclusion of a code in this section does not guarantee that it will be reimbursed. For further information on reimbursement guidelines, please see Administrative Policies on the Blue Cross Blue Shield of North Carolina web site at www.bcbsnc.com. They are listed in the Category Search on the Medical Policy search page.

Applicable service codes: 0266T, 0267T, 0268T, 0269T, 0270T, 0271T, 0272T, 0273T

BCBSNC may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included. 

Scientific Background and Reference Sources

BCBSA Medical Policy Reference Manual [Electronic Version]. 8.01.57, 8/11/11

National Institutes of Health (NIH). Rheos^® Pivotal Trial. Clinical Trial #NCT00442286. Retrieved on August 12, 2011 from http://clinicaltrials.gov/ct2/show/NCT00442286?term=NCT00442286&rank=1

National Institutes of Health (NIH). Rheos^® Feasibility Trial. Clinical trial #NCT01077180. Retrieved on August 12, 2011 from http://clinicaltrials.gov/ct2/show/NCT01077180?term=NCT01077180&rank=1

National Institutes of Health (NIH). Rheos HOPE4HF Trial. Clinical Trial # NCT00957073. Retrieved on August 12, 2011 from http://clinicaltrials.gov/ct2/show/NCT00957073?term=NCT00957073&rank=1

Papademetriou V, Doumas M, Faselis C, et.al. Carotid Baroreceptor Stimulation for the Treatment of Resistant Hypertension. Int J Hypertens. 2011; 2011:964394. Retrieved on August 12, 2011 from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3124753/?tool=pubmed

Specialty Matched Consultant Advisory Panel review 4/2012.

BCBSA Medical Policy Reference Manual [Electronic Version]. 8.01.57, 8/9/12

Specialty Matched Consultant Advisory Panel review 4/2013

Medical Director review 4/2013

Specialty Matched Consultant Advisory Panel review 4/2014

Medical Director review 4/2014

BCBSA Medical Policy Reference Manual [Electronic Version]. 8.01.57, 8/14/14

Specialty Matched Consultant Advisory Panel review 4/2015

Medical Director review 4/2015

BCBSA Medical Policy Reference Manual [Electronic Version]. 8.01.57, 9/10/15

Specialty Matched Consultant Advisory Panel review 4/2016

Medical Director review 4/2016

Specialty Matched Consultant Advisory Panel review 4/2017

Medical Director review 4/2017

BCBSA Medical Policy Reference Manual [Electronic Version]. 8.01.57, 6/2017

Medical Director review 5/2017

BCBSA Medical Policy Reference Manual [Electronic Version]. 8.01.57, 6/2018

Specialty Matched Consultant Advisory Panel review 4/2018

Medical Director review 4/2018

BCBSA Medical Policy Reference Manual [Electronic Version]. 8.01.57, 6/2019

Specialty Matched Consultant Advisory Panel review 10/2019

Medical Director review 10/2019

Food and Drug Administration: FDA approves new device to improve symptoms in patients with advanced heart failure. August 16, 2019, reviewed via: https://www.fda.gov/news-events/press-announcements/fda-approves-new-device-improve-symptoms-patients-advanced-heart-failure

BCBSA Medical Policy Reference Manual [Electronic Version]. 8.01.57, 6/2020

Specialty Matched Consultant Advisory Panel review 10/2020

Medical Director review 10/2020

BCBSA Medical Policy Reference Manual [Electronic Version]. 8.01.57, 6/2021

Specialty Matched Consultant Advisory Panel review 10/2021

Medical Director review 10/2021

Specialty Matched Consultant Advisory Panel review 10/2022

Medical Director review 10/2022

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. 

Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED). 16 Aug 2019; https://www.accessdata.fda.gov/cdrh_docs/pdf18/P180050b.pdf

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

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

Specialty Matched Consultant Advisory Panel review 10/2023

Medical Director review 10/2023

Specialty Matched Consultant Advisory Panel review 10/2024

Medical Director review 10/2024

Psotka MA, Abraham WT, Fiuzat M, et al. Functional and Symptomatic Clinical Trial Endpoints: The HFC-ARC Scientific Expert Panel. JACC Heart Fail. Dec 2022; 10(12): 889-901. PMID 36456063

Psotka MA, von Maltzahn R, Anatchkova M, et al. Patient-Reported Outcomes in Chronic Heart Failure: Applicability for Regulatory Approval. JACC Heart Fail. Oct 2016; 4(10): 791-804. PMID 27395351

Spertus JA, Jones PG, Sandhu AT, et al. Interpreting the Kansas City Cardiomyopathy Questionnaire in Clinical Trials and Clinical Care: JACC State-of-the-Art Review. J Am Coll Cardiol. Nov 17 2020; 76(20): 2379-2390. PMID 33183512

Gonzalez-Saenz de Tejada M, Bilbao A, Ansola L, et al. Responsiveness and minimal clinically important difference of the Minnesota living with heart failure questionnaire. Health Qual Life Outcomes. Feb 14 2019; 17(1): 36. PMID 30764842

Lewis EF, Claggett BL, McMurray JJV, et al. Health-Related Quality of Life Outcomes in PARADIGM-HF. Circ Heart Fail. Aug 2017; 10(8). PMID 28784687

Nassif ME, Windsor SL, Tang F, et al. Dapagliflozin Effects on Biomarkers, Symptoms, and Functional Status in Patients With Heart Failure With Reduced Ejection Fraction: The DEFINE-HF Trial. Circulation. Oct 29 2019; 140(18): 1463-1476. PMID 31524498

Fuentes-Abolafio IJ, Stubbs B, Pérez-Belmonte LM, et al. Physical functional performance and prognosis in patients with heart failure: a systematic review and meta-analysis. BMC Cardiovasc Disord. Dec 09 2020; 20(1): 512. PMID 33297975

ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. Jul 01 2002; 166(1): 111-7. PMID 12091180

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

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

Zile MR, Lindenfeld J, Weaver FA, et al. Baroreflex activation therapy in patients with heart failure and a reduced ejection fraction: Long-term outcomes. Eur J Heart Fail. Apr 12 2024. PMID 38606555

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

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

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

Guckel D, Eitz T, El Hamriti M, et al. Baroreflex activation therapy in advanced heart failure therapy: insights from a real-world scenario. ESC Heart Fail. Feb 2023; 10(1): 284-294. PMID 36208130

Specialty Matched Consultant Advisory Panel review 10/2025

Medical Director review 10/2025

Policy Implementation/Update Information

9/30/11 New policy developed. Baroreflex stimulation devices are considered investigational for all applications, including treatment of resistant hypertension. Medical Director review 9/2011.(mco)

5/15/12 Specialty Matched Consultant Advisory Panel review 4/2012. Policy Guidelines updated.(mco)

10/16/12 Description section updated. References updated. No changes to Policy Statement. (mco)

4/30/13 Specialty Matched Consultant Advisory Panel review 4/2013. Medical Director review 4/2013. No changes to Policy Statement. (mco)

5/13/14 Specialty Matched Consultant Advisory Panel review 4/2014. Medical Director review 4/2014. No changes to Policy Statements. (mco)

10/14/14 References updated. No changes to Policy Statement. (td)

5/26/15 Policy Statements remain unchanged. References updated. Specialty Matched Consultant Advisory Panel review 4/29/2015. Medical Director review 4/2015. (td)

10/30/15 When Not Covered section updated to include heart failure as an example in the investigational statement. Policy Guidelines section updated. References updated. (td)

5/31/16 Description section updated. Reference section updated. Specialty Matched Consultant Advisory Panel review 4/27/2016. Medical Director review 4/2016.

5/26/17 Specialty Matched Consultant Advisory Panel review 4/2017. Medical Director review 4/2017. (jd)

6/3017 Description section, regulatory status and policy guidelines updated. References updated. Medical Director review 5/2017. (jd)

5/11/18 Specialty Matched Consultant Advisory Panel review 4/2018. Medical Director review 4/2018. (jd)

10/29/19 Regulatory status updated with recent approval by FDA for Barostim Neo System. Specialty Matched Consultant Advisory Panel review 10/2019. Medical Director review 10/2019. (jd)

11/10/20 Minor updates to the background, regulatory status and policy guidelines. References updated. Specialty Matched Consultant Advisory Panel review 10/2020. Medical Director review 10/2020. (jd)

11/2/21 References updated. Specialty Matched Consultant Advisory Panel review 10/2021. Medical Director review 10/2021. (jd)

5/31/22 The following reimbursement policy was added to Related Policies section: Facility Billing Requirements. (jd)

11/1/22 Description, Policy Guidelines and References updated. No change to policy statement. Specialty Matched Consultant Advisory Panel review 10/2022. Medical Director review 10/2022. (tm)

11/7/23 Description, Policy Guidelines and References updated. No change to policy statement. Specialty Matched Consultant Advisory Panel review 10/2023. Medical Director review 10/2023. (tm)

11/13/24 Description and References updated. No change to policy statement. Specialty Matched Consultant Advisory Panel review 10/2024. Medical Director review 10/2024. (tm)

10/29/25 Description, Policy Guidelines and References updated. When Not Covered section updated to remove examples of hypertension and heart failure and now reads: “Baroreflex stimulation devices are considered investigational for all applications.” Specialty Matched Consultant Advisory Panel review 10/2025. Medical Director review 10/2025. (tm)