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Baroreflex Stimulation Devices

Policy Number: MP-480

Latest Review Date: May 2022

Category: Surgical                                                                

POLICY:

The use of baroreflex stimulation implanted devices are considered investigational in all situations, including but not limited to treatment of hypertension and heart failure.

DESCRIPTION OF PROCEDURE OR SERVICE:

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

KEY POINTS:

This policy is updated regularly with searches of the MEDLINE database. The most recent update reviews the literature through April 1, 2022.

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. In addition 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 and a post hoc subgroup analysis of an RCT. Relevant outcomes are overall survival, (OS) functional outcomes, quality of life, hospitalizations, medication use, and treatment-resistant morbidity. The expedited phase of the 2019 RCT was used by the FDA 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 the extended trial is still underway, 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. A second, larger, RCT designed to assess the effects of the intervention on mortality, safety, functional, 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.

Practice Guidelines and Position Statements:

American Heart Association

In 2017, the American Heart Association issued a joint guideline for the management of high blood pressure in adults with the American College of Cardiology and multiple other organizations. This guideline notes that studies have not provided sufficient evidence to support the use of baroreceptor pacing for managing resistant hypertension.

National Institute for Health and Care Excellence

In 2015, the National Institute for Health and Care Excellence (NICE) issued guidance that stated: “Current evidence on the safety and efficacy of implanting a baroreceptor stimulation device for resistant hypertension is inadequate. Therefore, this procedure should only be used in the context of research.”

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Baroreflex activation therapy®, BAT®, Rheos® Hypertension system, baroreflex stimulation, carotid baroreflex stimulation, Rheos® BAT system, Barostim Therapy®, Barostim neo® Legacy System

APPROVED BY GOVERNING BODIES:

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 – 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), have a left ventricular ejection fraction ≤ 35%, a 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. Expedited Access Pathway will hasten the approval of novel therapies that target life-threatening conditions.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING:

CPT Codes:   

0266T

Implantation or replacement of carotid sinus baroreflex activation device; total system (includes generator placement, unilateral or bilateral lead placement, intra-operative interrogation, programming, and repositioning, when performed)

0267T

; lead only, unilateral (includes intra-operative interrogation, programming, and repositioning when performed)

0268T

; pulse generator only (includes intra-operative interrogation, programming, and repositioning when performed)

0269T

Revision or removal of carotid sinus baroreflex activation device; total system (includes generator placement, unilateral or bilateral lead placement, intra-operative interrogation, programming, and repositioning, when performed)

0270T

; lead only, unilateral (includes intra-operative interrogation, programming, and repositioning when performed)

0271T

; pulse generator only (includes intra-operative interrogation, programming, and repositioning when performed)

0272T

Interrogation device evaluation (in person), carotid sinus baroreflex activation system, including telemetric iterative communication with the implantable device to monitor system diagnostic and programmed therapy values, with interpretation and report (e.g., battery status, lead impedance, pulse amplitude, pulse width, therapy frequency, pathway mode, burst mode, therapy start/stop times each day)

0273T

; with programming

REFERENCES:

  1. 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.
  2. Acelajado MC, Calhoun DA. Resistant hypertension, secondary hypertension, and hypertensive crises; diagnostic evaluation and treatment. Cardiol Clin 2010; 28(4):639-54.
  3. 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. JACC. Published online April 1, 2022. https://doi.org/10.1016/j.jacc.2021.12.012
  4. 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 2012; 6(2):152-8.
  5. 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 2011; 58(7):765-73.
  6. 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.
  7. 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; http://www.cvrx.com/newsroom/cvrx-announces-expedited-access-pathway-designation-by-fda-for-barostimtherapy-for-the-treatment-of-heart-failure-in-order-to-accelerate-access-for-us-patients/. Accessed April 6, 2022.
  8. Doumas M, Papademetriou V, Douma S et al. Benefits from treatment and control of patients with resistant hypertension. Int J Hypertens 2010; 2011:318549.

  9. 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 April 6, 2022.
  10. Food and Drug Administration. Premarket Approval (PMA): Barostim Neo System. 16 Aug 2019; https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180050. Accessed April 6, 2022.
  11. Food and Drug Administration. Humanitarian Device Exemption (HDE): Barostim Neo Legacy System. 2014; www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?id=h130007. Accessed April 6, 2022.
  12. Food and Drug Administration. Letter: Expedited Access Pathway (EAP) Designation. 2015; www.cvrx.com/wp-content/uploads/2013/05/900108-001_Q150760_FDA-Grant-Letter-for-EAP-Designation-Request_26Jun15-1.pdf. Accessed April 6, 2022.
  13. 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. 2018 Sep 1;266:187-192.
  14. Heusser K, Tank J, Engeli S et al. Carotid baroreceptor stimulation, sympathetic activity, baroreflex function, and blood pressure in hypertensive patients. Hypertension 2010; 55(3):619-26.
  15. 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. Jun 11 2012; 6(4):270-76.
  16. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  17. National Institute for Clinical and Care Excellence (NICE). Implanting a baroreceptor stimulation device for resistant hypertension [IPG533]. 2015; www.nice.org.uk/guidance/ipg533. Accessed April 6, 2022.
  18. Sanchez L NM, et al. Baroreflex activation therapy sustainably lowers blood pressure in patients with resistant hypertension: Results from the Rheos Pivotal trial. JACC Vol. 59, No. 5; January 31, 2012:539–43
  19. 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 2010; 56(15):1254-8.
  20. Tordior JH, Scheffers I, Schmidli J et al. An implantable carotid sinus baroreflex activation system: surgical technique and short-term outcome from a multi-center feasibility trial for the treatment of resistant hypertension. Eur J Vasc Endovasc Surg 2007; 33(4):414-21.
  21. 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):701-709.
  22. 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.
  23. 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.
  24. Zhang, J, Zhou, S, et al. Carotid baroreceptor stimulation: a potential solution for resistant hypertension. Interventional Rad 2014; 2(3):118-122.
  25. 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.
  26. 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.

POLICY HISTORY:

Medical Policy Panel, August 2011

Medical Policy Group, August 2011 (2): New Policy

Medical Policy Administration Committee, September 2011

Available for comment September 22 through November 7, 2011

Medical Policy Group, August 2012 (2): Updated Description, Key Points, and References

Medical Policy Group August 2013 (4): Updated Key Points and References, no change to the policy statement at this time.

Medical Policy Panel, August 2014

Medical Policy Group, August 2014 (3):  2014 Updates to Description & Key Points; no change in policy statement

Medical Policy Group, March 2015 (6):  Added Reference; no change to policy statement.

Medical Policy Panel, September 2015

Medical Policy Group, September 2015 (6):  Updates to Key Points; no change to policy statement.

Medical Policy Panel, May 2017

Medical Policy Group, June 2017 (6): Updates to Description, Key Points, Governing Bodies, Practice Guidelines, Key Words and References. No change to policy statement.

Medical Policy Panel, May 2018

Medical Policy Group, May 2018 (6): Updates to Key Points.

Medical Policy Panel May 2019

Medical Policy Group, May 2019 (6): Updates to Key Points and References.

Medical Policy Panel, May 2020

Medical Policy Group, May 2020 (6): Updates to Description, Key Points, Governing Bodies, Practice Guidelines and References. No change to policy intent.

Medical Policy Panel, May 2021

Medical Policy Group, May 2021 (6): Updates to Description, Key Points, Practice Guidelines, Governing Bodies and References. Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Panel, May 2022

Medical Policy Group, May 2022 (6): Updates to Key Points and References.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.