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Medical Policy Baroreflex Stimulation Devices Table of Contents • Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description
• References
• Authorization Information • Policy History

Policy Number: 595

BCBSA Reference Number: 8.01.57 (For Plan internal use only) NCD/LCD: N/A Related Policies
Radiofrequency Ablation of the Renal Sympathetic Nerves as a Treatment for Resistant Hypertension,

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Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity
Medicare HMO BlueSM and Medicare PPO BlueSM Members
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.

Baroreflex stimulation therapy is INVESTIGATIONAL for all other indications.

Prior Authorization Information
Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

Outpatient Commercial Managed Care (HMO and POS) This is not a covered service. Commercial PPO and Indemnity This is not a covered service. Medicare HMO BlueSM This is not a covered service. Medicare PPO BlueSM This is not a covered service.

CPT Codes / HCPCS Codes / ICD Codes

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Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

The following codes are included below for informational purposes only; this is not an all-inclusive list.

The following CPT and HCPCS codes are considered investigational for Commercial Members: Managed Care (HMO and POS), PPO, Indemnity, Medicare HMO Blue and Medicare PPO Blue:

CPT Codes CPT codes:

Code Description 64654 Initial open implantation of baroreflex activation therapy (BAT) modulation system, including lead placement onto the carotid sinus, lead tunnelling, connection to a pulse generator placed in a distant subcutaneous pocket (ie, total system), and intraoperative interrogation and programming 64655 Revision or replacement of baroreflex activation therapy (BAT) modulation system, with intraoperative interrogation and programming; lead only 64656 Revision or replacement of baroreflex activation therapy (BAT) modulation system, with intraoperative interrogation and programming; pulse generator only 64657 Removal of baroreflex activation therapy (BAT) modulation system; total system, including lead and pulse generator 64658 Removal of baroreflex activation therapy (BAT) modulation system; lead only 64659 Removal of baroreflex activation therapy (BAT) modulation system; pulse generator only 93145 Interrogation device evaluation (in person), carotid sinus baroreflex activation therapy (BAT) modulation system including telemetric iterative communication with the implantable device to monitor device diagnostics and programmed therapy values, with interpretation and report (eg, battery status, lead impedance, pulse amplitude, pulse width, therapy frequency, pathway mode, burst mode, therapy start/stop times each day); without programming 93146 Interrogation device evaluation (in person), carotid sinus baroreflex activation therapy (BAT) modulation system including telemetric iterative communication with the implantable device to monitor device diagnostics and programmed therapy values, with interpretation and report (eg, battery status, lead impedance, pulse amplitude, pulse width, therapy frequency, pathway mode, burst mode, therapy start/stop times each day); with programming, including optimization of tolerated therapeutic level setting HCPCS Codes:
HCPCS codes: Code Description C1825 Generator, neurostimulator (implantable), non-rechargeable with carotid sinus baroreceptor stimulation lead(s)

Description 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

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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 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 events. As a result, there is a large unmet need for additional treatments.

Summary 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.

Summary of Evidence 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, a non-randomized controlled trial, 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 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, but the confidence interval for the mortality outcome implies that an increase in risk of mortality is unlikely. 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 insufficientto determine that the technology results in an improvement in the net health outcome.

Policy History Date Action 1/2026 Clarified coding information. 10/2025 Annual policy review. Policy updated with literature review through June 16, 2025; references added. The indication for Baroreflex stimulation therapy for individuals with treatment-resistant hypertension was removed as the device is no longer marketed for this indication. The remaining policy statement is unchanged. 7/2023 Annual policy review. References added. Policy statement unchanged. 1/2023 PA information section clarified to include Medicare.
6/2022 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 6/2021 Annual policy review. Description, summary, and references updated. Policy statements unchanged.

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1/2021 Medicare information removed. See MP #132 Medicare Advantage Management for local coverage determination and national coverage determination reference.
Clarified coding information.
7/2020 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 6/2019 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 6/2018 Annual policy review. New references added. Summary clarified. 6/2017 Annual policy review. New references added. 2/2016 Annual policy review. Hypertension and heart failure added as examples in investigational policy statement. Effective 2/1/2016. 12/2013 Annual policy review. New references added. 11/2011-4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates.
No changes to policy statements.
1/1/2012 New policy, effective 1/1/2012, describing ongoing non-coverage.

Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

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. 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.
5. 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
6. 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
7. 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
8. 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
9. 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
10. 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
11. 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

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12. 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
13. 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
14. 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
15. 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
16. 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
17. 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
18. 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
19. 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
20. 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
21. 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
22. Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the management of heart failure: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. Oct 15 2013; 128(16): 1810-52. PMID 23741057