Archive Date: 10/01/2023

This document has been archived because it has outdated information. It is for historical information only and should not be consulted for clinical use. Current versions of guidelines are available on the Carelon Medical Benefits Management website at http://guidelines.carelonmedicalbenefitsmanagement.com

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Status: Created Effective Date: 01/01/2023

Doc ID: CAR08-0123.1 Last Review Date: 08/29/2022

Approval and implementation dates for specific health plans may vary. Please consult the applicable health plan for more details.

Clinical Appropriateness Guidelines

Cardiology

Appropriate Use Criteria: Permanent Implantable Pacemakers

Proprietary

© 2023 Carelon Medical Benefits Management, Inc. All rights reserved.

Table of Contents

Description and Application of the Guidelines

General Clinical Guideline

Permanent Implantable Pacemakers

Codes

General Information

Clinical Indications

Exclusions

References

History

Description and Application of the Guidelines

The Carelon Clinical Appropriateness Guidelines (hereinafter “the Carelon Clinical Appropriateness Guidelines” or the “Guidelines”) are designed to assist providers in making the most appropriate treatment decision for a specific clinical condition for an individual. As used by Carelon, the Guidelines establish objective and evidence-based criteria for medical necessity determinations where possible. In the process, multiple functions are accomplished:

• To establish criteria for when services are medically necessary (i.e., in general, shown to be effective in improving health outcomes and considered the most appropriate level of service)
• To assist the practitioner as an educational tool
• To encourage standardization of medical practice patterns
• To curtail the performance of inappropriate and/or duplicate services
• To advocate for patient safety concerns
• To enhance the quality of health care
• To promote the most efficient and cost-effective use of services

The Carelon guideline development process complies with applicable accreditation standards, including the requirement that the Guidelines be developed with involvement from appropriate providers with current clinical expertise relevant to the Guidelines under review and be based on the most up-to-date clinical principles and best practices. Relevant citations are included in the References section attached to each Guideline. Carelon reviews all of its Guidelines at least annually.

Carelon makes its Guidelines publicly available on its website twenty-four hours a day, seven days a week. Copies of the Carelon Clinical Appropriateness Guidelines are also available upon oral or written request. Although the Guidelines are publicly-available, Carelon considers the Guidelines to be important, proprietary information of Carelon, which cannot be sold, assigned, leased, licensed, reproduced or distributed without the written consent of Carelon.

Carelon applies objective and evidence-based criteria, and takes individual circumstances and the local delivery system into account when determining the medical appropriateness of health care services. The Carelon Guidelines are just guidelines for the provision of specialty health services. These criteria are designed to guide both providers and reviewers to the most appropriate services based on a patient’s unique circumstances. In all cases, clinical judgment consistent with the standards of good medical practice should be used when applying the Guidelines. Guideline determinations are made based on the information provided at the time of the request. It is expected that medical necessity decisions may change as new information is provided or based on unique aspects of the patient’s condition. The treating clinician has final authority and responsibility for treatment decisions regarding the care of the patient and for justifying and demonstrating the existence of medical necessity for the requested service. The Guidelines are not a substitute for the experience and judgment of a physician or other health care professionals. Any clinician seeking to apply or consult the Guidelines is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient’s care or treatment.

The Guidelines do not address coverage, benefit or other plan specific issues. Applicable federal and state coverage mandates take precedence over these clinical guidelines. If requested by a health plan, Carelon will review requests based on health plan medical policy/guidelines in lieu of the Carelon Guidelines. Pharmaceuticals, radiotracers, or medical devices used in any of the diagnostic or therapeutic interventions listed in the Guidelines must be FDA approved or conditionally approved for the intended use. However, use of an FDA approved or conditionally approved product does not constitute medical necessity or guarantee reimbursement by the respective health plan.

The Guidelines may also be used by the health plan or by Carelon for purposes of provider education, or to review the medical necessity of services by any provider who has been notified of the need for medical necessity review, due to billing practices or claims that are not consistent with other providers in terms of frequency or some other manner.

General Clinical Guideline

Clinical Appropriateness Framework

Critical to any finding of clinical appropriateness under the guidelines for a specific diagnostic or therapeutic intervention are the following elements:

• Prior to any intervention, it is essential that the clinician confirm the diagnosis or establish its pretest likelihood based on a complete evaluation of the patient. This includes a history and physical examination and, where applicable, a review of relevant laboratory studies, diagnostic testing, and response to prior therapeutic intervention.
• The anticipated benefit of the recommended intervention should outweigh any potential harms that may result (net benefit).
• Current literature and/or standards of medical practice should support that the recommended intervention offers the greatest net benefit among competing alternatives.
• Based on the clinical evaluation, current literature, and standards of medical practice, there exists a reasonable likelihood that the intervention will change management and/or lead to an improved outcome for the patient.

If these elements are not established with respect to a given request, the determination of appropriateness will most likely require a peer-to-peer conversation to understand the individual and unique facts that would supersede the requirements set forth above. During the peer-to-peer conversation, factors such as patient acuity and setting of service may also be taken into account.

Simultaneous Ordering of Multiple Diagnostic or Therapeutic Interventions

Requests for multiple diagnostic or therapeutic interventions at the same time will often require a peer-to-peer conversation to understand the individual circumstances that support the medical necessity of performing all interventions simultaneously. This is based on the fact that appropriateness of additional intervention is often dependent on the outcome of the initial intervention.

Additionally, either of the following may apply:

• Current literature and/or standards of medical practice support that one of the requested diagnostic or therapeutic interventions is more appropriate in the clinical situation presented; or
• One of the diagnostic or therapeutic interventions requested is more likely to improve patient outcomes based on current literature and/or standards of medical practice.

Repeat Diagnostic Intervention

In general, repeated testing of the same anatomic location for the same indication should be limited to evaluation following an intervention, or when there is a change in clinical status such that additional testing is required to determine next steps in management. At times, it may be necessary to repeat a test using different techniques or protocols to clarify a finding or result of the original study.

Repeated testing for the same indication using the same or similar technology may be subject to additional review or require peer-to-peer conversation in the following scenarios:

• Repeated diagnostic testing at the same facility due to technical issues
• Repeated diagnostic testing requested at a different facility due to provider preference or quality concerns
• Repeated diagnostic testing of the same anatomic area based on persistent symptoms with no clinical change, treatment, or intervention since the previous study
• Repeated diagnostic testing of the same anatomic area by different providers for the same member over a short period of time

Repeat Therapeutic Intervention

In general, repeated therapeutic intervention in the same anatomic area is considered appropriate when the prior intervention proved effective or beneficial and the expected duration of relief has lapsed. A repeat intervention requested prior to the expected duration of relief is not appropriate unless it can be confirmed that the prior intervention was never administered.

Permanent Implantable Pacemakers

Codes

The following code list is not meant to be all-inclusive. Authorization requirements will vary by health plan. Please consult the applicable health plan for guidance on specific procedure codes.

Specific CPT codes for services should be used when available. Nonspecific or not otherwise classified codes may be subject to additional documentation requirements and review.

CPT/HCPCS

CPT® (Current Procedural Terminology) is a registered trademark of the American Medical Association (AMA). CPT® five digit codes, nomenclature and other data are copyright by the American Medical Association. All Rights Reserved. AMA does not directly or indirectly practice medicine or dispense medical services. AMA assumes no liability for the data contained herein or not contained herein.

33206	Insertion of new or replacement of permanent pacemaker with transvenous electrode(s); atrial
33207	Insertion of new or replacement of permanent pacemaker with transvenous electrode(s); ventricular
33208	Insertion of new or replacement of permanent pacemaker with transvenous electrode(s); atrial and ventricular
33212	Insertion of pacemaker pulse generator only; single existing single lead
33213	Insertion of pacemaker pulse generator only; with existing dual leads
33214	Upgrade of implanted pacemaker system, conversion of single chamber system to dual chamber system (includes removal of previously placed pulse generator, testing of existing lead, insertion of new lead, insertion of new pulse generator)
33227	Removal of permanent pacemaker pulse generator with replacement of pacemaker pulse generator; single lead system
33228	Removal of permanent pacemaker pulse generator with replacement of pacemaker pulse generator; dual lead system
33274	Transcatheter insertion or replacement of permanent leadless pacemaker, right ventricular, including imaging guidance (e.g., fluoroscopy, venous ultrasound, ventriculography, femoral venography) and device evaluation (e.g., interrogation or programming), when performed

General Information

Guideline Scope

This guideline addresses the appropriate use of permanent implantable pacemakers for the management of bradyarrhythmias. It does not address the use of temporary pacemakers, pacemakers for management of heart failure (cardiac resynchronizations therapy), or implantable defibrillators. Occasionally, the clinical scenario requiring implantation of a permanent pacemaker arises during hospitalization for another reason (e.g., following valve replacement, bypass surgery, or myocardial infarction). These procedures do not require prior authorization and are therefore not addressed in this document.

Overriding Considerations

• An arrhythmia is considered to be “documented” when it has been permanently recorded such that a copy can be provided on request.
• An arrhythmia is considered to be “symptomatic” when symptoms have occurred at the same time as the arrhythmia. When symptoms and the arrhythmia are temporally separated, the arrhythmia cannot be described as symptomatic.
• In general, placement of a pacemaker is not appropriate in patients who are currently taking medications which cause bradyarrhythmias and/or conduction disturbance. Whenever possible, such medications should be discontinued unless there are no acceptable alternative therapies.
• The decision to treat bradyarrhythmias or conduction disturbance with a permanent pacemaker assumes that reversible causes (e.g., electrolyte disturbance, hypothermia, drug toxicity, hypothyroidism, infection, inflammation, ischemia, etc.) have been excluded.
• Pacemaker device selection and utilization (manufacturer/capabilities/mode settings, etc.) are outside the scope of this guideline, are at the discretion of the physician, and should be optimized to the patient’s individual clinical situation.
• When a patient meets criteria for permanent pacemaker therapy and has an indication for cardiac resynchronization therapy or implantable defibrillator, a single device which meets all of the patient’s clinical needs should be selected.

Definitions

Extracted from 2018 ACC/AHA/HRS guideline on the evaluation and management of patients with bradycardia and cardiac conduction delay.¹³

Symptomatic arrhythmia: For purposes of guideline interpretation, symptomatic arrhythmia refers to a documented arrhythmia that is directly responsible for development of the clinical manifestations of syncope or presyncope, transient dizziness or lightheadedness, heart failure symptoms, or confusional states resulting from cerebral hypoperfusion attributable to slow heart rate. In order for an arrhythmia to be considered symptomatic, a temporal association between the arrhythmia and symptoms must be demonstrated.

Sinus node dysfunction refers to dysfunction of the sinus node or surrounding atrial tissue which may give rise to any of the following rhythm disturbances:

• Sinus bradycardia (sinus rate < 50 bpm)
• Ectopic atrial bradycardia (atrial depolarization attributable to an atrial pacemaker other than the sinus node with a rate < 50 bpm)
• Sinoatrial exit block: Evidence that blocked conduction between the sinus node and adjacent atrial tissue is present. (Multiple electrocardiographic manifestations including “group beating” of atrial depolarization and sinus pauses).
• Sinus pause: Sinus node depolarizes > 3 seconds after the last atrial depolarization
• Sinus node arrest: No evidence of sinus node depolarization
• Tachycardia-bradycardia (“tachy-brady”) syndrome: Sinus bradycardia, ectopic atrial bradycardia, or sinus pause alternating with periods of abnormal atrial tachycardia, atrial flutter, or atrial fibrillation. The tachycardia may be associated with suppression of sinus node automaticity and a sinus pause of variable duration when the tachycardia terminates.
• Chronotropic incompetence: Broadly defined as the inability of the heart to increase its rate commensurate with increased activity or demand, in many studies translates to failure to attain 80% of expected heart rate reserve during exercise.
• Isorhythmic dissociation: Atrial depolarization (from either the sinus node or ectopic atrial site) is slower than ventricular depolarization (from an atrioventricular nodal, His bundle, or ventricular site).

Atrioventricular block is the slowing or absence of impulse conduction at the atrioventricular (AV) node. It may manifest as any of the following:

• First-degree atrioventricular block: P waves associated with 1:1 atrioventricular conduction and a PR interval > 200 milliseconds
• Second-degree atrioventricular block: P waves with a constant rate (< 100 bpm) where atrioventricular conduction is present but not 1:1
  • Mobitz type I: P waves with a constant rate (< 100 bpm) with a periodic single nonconducted P wave associated with P waves before and after the nonconducted P wave with inconstant PR intervals
  • Mobitz type II: P waves with a constant rate (< 100 bpm) with a periodic single nonconducted P wave associated with other P waves before and after the nonconducted P wave with constant PR intervals (excluding 2:1 atrioventricular block)
  • 2:1 atrioventricular block: P waves with a constant rate (or near constant rate because of ventriculophasic sinus arrhythmia) rate (< 100 bpm) where every other P wave conducts to the ventricles
  • Advanced, high-grade or high-degree atrioventricular block: ≥ 2 consecutive P waves at a constant physiologic rate that do not conduct to the ventricles with evidence for some atrioventricular conduction
• Third-degree atrioventricular block (complete heart block): No evidence of atrioventricular conduction

Infranodal block: Atrioventricular conduction block where clinical evidence or electrophysiologic evidence suggests that the conduction block occurs distal to the atrioventricular node

Vagally mediated atrioventricular block: Any type of atrioventricular block mediated by heightened parasympathetic tone

Complex ventricular ectopy: Multifocal ectopy, sustained or non-sustained ventricular tachycardia, bigeminy, couplets, triplets or R-on-T premature ventricular complexes

Neuromuscular diseases: Conduction system dysfunction is a feature of some neuromuscular diseases. For purposes of guideline interpretation, patients can be considered to have a neuromuscular disease if they have any of the following: myotonic dystrophy (type 1), Emery-Dreifuss muscular dystrophy, limb girdle (type 1b) muscular dystrophy, dystrophinopathies (Duchenne or Becker muscular dystrophy), or Kearns-Sayre syndrome.

Clinical Indications

Documented sinus node dysfunction

Permanent pacemaker placement is considered medically necessary for documented sinus node dysfunction when the patient takes no medications which would cause sinus node dysfunction (or withholding/dose reduction of such medications would be contraindicated) and ANY of the following apply:

• Symptomatic arrhythmias with sinus node dysfunction when symptoms are clearly attributable to the arrhythmia
• Symptomatic chronotropic incompetence
• Symptomatic tachy-brady syndrome when the symptoms are clearly attributable to bradyarrhythmia

Note: In the absence of symptoms which can be temporally correlated with sinus node dysfunction, there is no minimum heart rate or pause duration at which permanent pacemaker placement would be considered appropriate.

Documented atrioventricular (AV) block

Permanent pacemaker placement is considered medically necessary for documented AV block when reversible causes of AV block are absent and the patient takes no medications which would cause AV node dysfunction (or withholding such medications would be contraindicated) and ANY of the following apply:

• Acquired third-degree AV block (symptomatic or asymptomatic)
• Acquired high-grade second-degree block (symptomatic or asymptomatic)
• Acquired Mobitz type II second-degree AV block (symptomatic or asymptomatic)
• Symptomatic Mobitz type I second-degree AV block when symptoms are clearly attributable to the AV block
• Symptomatic first degree AV block when PR interval is ≥ 300 milliseconds and symptoms are clearly attributable to the AV block
• Permanent atrial fibrillation and symptomatic bradycardia
• Neuromuscular disease with expected survival more than one year and ANY of the following:
  • Third degree AV block
  • Second degree AV block (type 1, type 2, 2:1 AV block, and high grade AV block)
  • PR interval > 240 milliseconds
  • HV interval ≥ 70 milliseconds
• Infiltrative cardiomyopathy (e.g., sarcoidosis, amyloidosis) with expected survival more than one year and ANY of the following:
  • Third degree AV block
  • Second degree (Mobitz type II)
  • High grade AV block
• Congenital heart disease with ANY of the following:
  • Symptomatic bradycardia related to AV block
  • Congenital complete AV block with ANY of the following:
    • Bradycardia (symptomatic or asymptomatic)
    • Escape rhythm with a wide QRS complex
    • Mean daytime heart rate < 50 beats per minute
    • Complex ventricular ectopy
    • Ventricular dysfunction
• Postoperative AV block that is not expected to resolve with ANY of the following:
  • Third degree AV block
  • Second degree (Mobitz type II)
  • High grade AV block

Bundle branch block or fascicular block

Permanent pacemaker placement is considered medically necessary for bundle branch block or fascicular block (with 1:1 atrioventricular conduction) when ANY of the following apply:

• Alternating bundle branch block
• Syncope of unknown cause in a patient who has bundle branch block and EITHER of the following:
  • HV interval ≥ 70 milliseconds
  • Evidence of infranodal block on electrophysiology study
• Neuromuscular disease with expected survival more than one year and ANY of the following:
  • HV interval ≥ 70 milliseconds
  • QRS duration > 120 milliseconds
  • Fascicular block
• Anderson-Fabry disease with expected survival more than one year and QRS duration > 110 milliseconds

Exclusions

Leadless Pacemakers

There is no clinical evidence to show that the use of leadless pacemakers is appropriate in any of the scenarios addressed in the Clinical Indications section. Therefore, the use of leadless pacemakers is considered not medically necessary.

References

1. Baumgartner H, De Backer J, Babu-Narayan SV, et al. 2020 ESC Guidelines for the management of adult congenital heart disease. European heart journal. 2021;42(6):563-645. Epub 2020/08/30.
2. Brignole M, Auricchio A, Baron-Esquivias G, et al. 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: the Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). European heart journal. 2013;34(29):2281-329. Epub 2013/06/27.
3. Brignole M, Deharo JC, Menozzi C, et al. The benefit of pacemaker therapy in patients with neurally mediated syncope and documented asystole: a meta-analysis of implantable loop recorder studies. Europace. 2018;20(8):1362-6. Epub 2017/12/22.
4. Brignole M, Moya A, de Lange FJ, et al. 2018 ESC Guidelines for the diagnosis and management of syncope. European heart journal. 2018;39(21):1883-948. Epub 2018/03/22.
5. Chen BW, Wang ZG, Lv NQ, et al. The role of cardiac pacing in carotid sinus syndrome: a meta-analysis. Clin Auton Res. 2014;24(3):127-34.
6. Epstein AE, DiMarco JP, Ellenbogen KA, et al. 2012 ACCF/AHA/HRS focused update incorporated into the ACCF/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. Journal of the American College of Cardiology. 2013;61(3):e6-75. Epub 2012/12/26.
7. Glikson M, Nielsen JC, Kronborg MB, et al. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. European heart journal. 2021;42(35):3427-520. Epub 2021/08/30.
8. Hancock EW, Deal BJ, Mirvis DM, et al. AHA/ACCF/HRS recommendations for the standardization and interpretation of the electrocardiogram: part V: electrocardiogram changes associated with cardiac chamber hypertrophy: a scientific statement from the American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; the American College of Cardiology Foundation; and the Heart Rhythm Society. Endorsed by the International Society for Computerized Electrocardiology. Journal of the American College of Cardiology. 2009;53(11):992-1002. Epub 2009/03/14.
9. Ismail H, Raynor E, Zimetbaum P. Neuromuscular Disorders and the Role of the Clinical Electrophysiologist. JACC Clinical electrophysiology. 2017;3(10):1069-79. Epub 2018/05/16.
10. JCS Joint Working Group. Guidelines for Non-Pharmacotherapy of Cardiac Arrhythmias (JCS 2011). Circ J. 2013;77(1):249-74. Epub 2012/11/21.
11. Kabunga P, Lau AK, Phan K, et al. Systematic review of cardiac electrical disease in Kearns-Sayre syndrome and mitochondrial cytopathy. Int J Cardiol. 2015;181:303-10.
12. Kligfield P, Gettes LS, Bailey JJ, et al. Recommendations for the standardization and interpretation of the electrocardiogram: part I: the electrocardiogram and its technology a scientific statement from the American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; the American College of Cardiology Foundation; and the Heart Rhythm Society endorsed by the International Society for Computerized Electrocardiology. Journal of the American College of Cardiology. 2007;49(10):1109-27. Epub 2007/03/14.
13. Kusumoto FM, Schoenfeld MH, Barrett C, et al. 2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines, and the Heart Rhythm Society. Journal of the American College of Cardiology. 2019;74(7):932-87. Epub 2018/11/10.
14. Lau JK, Sy RW, Corbett A, et al. Myotonic dystrophy and the heart: A systematic review of evaluation and management. Int J Cardiol. 2015;184:600-8.
15. Mason JW, Hancock EW, Gettes LS, et al. Recommendations for the standardization and interpretation of the electrocardiogram: part II: electrocardiography diagnostic statement list a scientific statement from the American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; the American College of Cardiology Foundation; and the Heart Rhythm Society Endorsed by the International Society for Computerized Electrocardiology. Journal of the American College of Cardiology. 2007;49(10):1128-35. Epub 2007/03/14.
16. Rautaharju PM, Surawicz B, Gettes LS, et al. AHA/ACCF/HRS recommendations for the standardization and interpretation of the electrocardiogram: part IV: the ST segment, T and U waves, and the QT interval: a scientific statement from the American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; the American College of Cardiology Foundation; and the Heart Rhythm Society. Endorsed by the International Society for Computerized Electrocardiology. Journal of the American College of Cardiology. 2009;53(11):982-91. Epub 2009/03/14.
17. Shah MJ, Silka MJ, Silva JNA, et al. 2021 PACES Expert Consensus Statement on the Indications and Management of Cardiovascular Implantable Electronic Devices in Pediatric Patients. Heart Rhythm. 2021;18(11):1888-924. Epub 2021/08/08.
18. Surawicz B, Childers R, Deal BJ, et al. AHA/ACCF/HRS recommendations for the standardization and interpretation of the electrocardiogram: part III: intraventricular conduction disturbances: a scientific statement from the American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; the American College of Cardiology Foundation; and the Heart Rhythm Society: endorsed by the International Society for Computerized Electrocardiology. Circulation. 2009;119(10):e235-40. Epub 2009/02/21.
19. Sutton R, Ungar A, Sgobino P, et al. Cardiac pacing in patients with neurally mediated syncope and documented asystole: effectiveness analysis from the Third International Study on Syncope of Uncertain Etiology (ISSUE-3) Registry. Europace. 2014;16(4):595-9.
20. Varosy PD, Chen LY, Miller AL, et al. Pacing as a Treatment for Reflex-Mediated (Vasovagal, Situational, or Carotid Sinus Hypersensitivity) Syncope: A Systematic Review for the 2017 ACC/AHA/HRS Guideline for the Evaluation and Management of Patients With Syncope: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Journal of the American College of Cardiology. 2017;70(5):664-79.
21. Wagner GS, Macfarlane P, Wellens H, et al. AHA/ACCF/HRS recommendations for the standardization and interpretation of the electrocardiogram: part VI: acute ischemia/infarction: a scientific statement from the American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; the American College of Cardiology Foundation; and the Heart Rhythm Society. Endorsed by the International Society for Computerized Electrocardiology. Journal of the American College of Cardiology. 2009;53(11):1003-11. Epub 2009/03/14.

History

Status	Review Date	Effective Date	Action
Archived	n/a	10/01/2023	Not to be used for dates of service on or after 10/01/2023.
Created/ Reaffirmed	08/29/2022	01/01/2023	Independent Multispecialty Physician Panel (IMPP) review. Added references. Guidelines reaffirmed. Original effective date.
Reviewed	02/03/2020	01/01/2023	IMPP review.