Archive Date: 03/17/2024
This document has been archived because it has outdated information.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
Status: Revised/Updated Effective Date: 04/09/2023
Doc ID: CAR05-0423.1-U0124 Last Review Date: 01/23/2024, 05/09/2022
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: Cardiac Resynchronization Therapy
Proprietary
© 2024 Carelon Medical Benefits Management, Inc. All rights reserved.
Table of Contents
Description and Application of the Guidelines
Clinical Appropriateness Framework
Simultaneous Ordering of Multiple Diagnostic or Therapeutic Interventions
Repeat Diagnostic Intervention
Repeat Therapeutic Intervention
Cardiac Resynchronization Therapy
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. The Guidelines establish objective and evidence-based criteria for medical necessity determinations, where possible, that can be used in support of the following:
- To establish criteria for when services are medically necessary
- 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 address 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 and legal 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. Resources reviewed include widely used treatment guidelines, randomized controlled trials or prospective cohort studies, and large systematic reviews or meta-analyses. Carelon reviews all of its Guidelines at least annually.
Carelon makes its Guidelines publicly available on its website. Copies of the Guidelines are also available upon oral or written request. Additional details, such as summaries of evidence, a list of the sources of evidence, and an explanation of the rationale that supports the adoption of the Guidelines, are included in each guideline document.
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, and in the case of reviews for Medicare Advantage Plans, the Guidelines are only applied where there are not fully established CMS criteria. 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 is likely to outweigh any potential harms, including from delay or decreased access to services that may result (net benefit).
- Widely used treatment guidelines and/or current clinical literature and/or standards of medical practice should support that the recommended intervention offers the greatest net benefit among competing alternatives.
- There exists a reasonable likelihood that the intervention will change management and/or lead to an improved outcome for the patient.
Providers may be required to submit clinical documentation in support of a request for services. Such documentation must a) accurately reflect the clinical situation at the time of the requested service, and b) sufficiently document the ordering provider’s clinical intent.
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 justify a finding of clinical appropriateness. During the peer-to-peer conversation, factors such as patient acuity and setting of service may also be taken into account to the extent permitted by law.
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. Requests for on-going services may depend on completion of previously authorized services in situations where a patient’s response to authorized services is relevant to a determination of clinical appropriateness.
Cardiac Resynchronization Therapy
General Information
Description and Scope
Disparity in the timing of regional ventricular contraction, mechanical dyssynchrony, is seen in some patients with congestive heart failure and has adverse prognostic implications. Over the past 2 decades it has been established that biventricular pacing is associated with improved outcomes and/or well-being in some patients with mechanical dyssynchrony. This treatment is known as cardiac resynchronization therapy (CRT). This guideline addresses the appropriate use of CRT.
Before consideration is given to CRT, reversible causes of heart failure should be excluded or corrected (e.g., ischemia, tachycardia-mediated cardiomyopathy, or alcohol), and the patient should be reassessed following an adequate trial of guideline-directed pharmacological therapy.
Cardiac resynchronization therapy devices, whether used to prolong survival or improve well-being, should be reserved for patients whose general health is such that survival with meaningful quality of life (with the device) is expected to exceed one year.
This guideline outlines the clinical scenarios in which CRT is considered appropriate. Although many patients for whom CRT is deemed appropriate will also meet criteria for an implantable cardioverter defibrillator (ICD), patients who meet criteria for both CRT and ICD are managed with a single device capable of performing both functions. Such devices are known as CRT-implantable cardioverter-defibrillator (CRT-D) devices to differentiate them from CRT-pacemaker (CRT-P) devices, which perform pacing function and are not capable of providing defibrillation.
Definitions
Guideline-directed medical therapy: Maximum tolerated doses of appropriately titrated heart failure medication (to include beta blockers, ACE inhibitors or ARBs, aldosterone antagonists and diuretics). When a particular medication class is contraindicated, guideline-directed medical therapy definition can exclude that class.
New York Heart Association (NYHA) functional class: Symptom-based classification of the severity of heart failure as outlined below.
- Class I. Individuals with cardiac disease but without resulting limitation of physical activity; ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain; symptoms only occur on severe exertion.
- Class II. Individuals with cardiac disease resulting in slight limitation of physical activity; they are comfortable at rest; ordinary physical activity (e.g., moderate physical exertion, such as carrying shopping bags up several flights of stairs) results in fatigue, palpitation, dyspnea, or anginal pain.
- Class III. Individuals with cardiac disease resulting in marked limitation of physical activity; they are comfortable at rest; less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain.
- Class IV. Individuals with cardiac disease resulting in inability to carry on any physical activity without discomfort; symptoms of heart failure or the anginal syndrome may be present even at rest; if any physical activity is undertaken, discomfort is increased.
Clinical Indications
CRT-P device implantation
CRT-P is considered medically necessary when, following an adequate trial* of guideline-directed medical therapy for congestive heart failure, ALL of the following are present:
- Sinus rhythm
- Left ventricular ejection fraction (LVEF) ≤ 35%
- Prolonged QRS duration with EITHER of the following:
- ≥ 150 milliseconds (any morphology)
- 130-149 milliseconds with LBBB morphology
- NYHA class II, class III, or ambulatory class IV heart failure symptoms
- Correctable causes of congestive heart failure (e.g., ischemia, tachycardia-mediated cardiomyopathy) have been appropriately addressed
Note: Some patients who meet all criteria above may also meet criteria for an implantable defibrillator. In such situations, at the discretion of the provider (and following discussion with the patient), either CRT-D or CRT-P is considered appropriate.
CRT-P is considered medically necessary when, following an adequate trial* of guideline-directed medical therapy for congestive heart failure, ALL of the following are present:
- Atrial fibrillation
- Left ventricular ejection fraction (LVEF) ≤ 35%
- QRS duration ≥ 130 milliseconds (Note: Patients who undergo AV node ablation and have a post-ablation paced QRS duration of ≥ 130 milliseconds can be considered to have met this criterion)
- NYHA class III or ambulatory class IV
- Strategy to ensure high rate (≥ 90%) biventricular capture (adequate rate control medications or planning AV node ablation) or expectation that sinus rhythm will be restored
- Correctable causes of congestive heart failure (e.g., ischemia, tachycardia-mediated cardiomyopathy) have been appropriately addressed
Note: Some patients who meet all criteria above may also meet criteria for an implantable defibrillator. In such situations, at the discretion of the provider (and following discussion with the patient), either CRT-D or CRT-P is considered appropriate.
CRT-P is considered medically necessary for patients who meet ALL of the following:
- Sinus rhythm or atrial fibrillation
- Criteria for permanent pacemaker implantation
- Left ventricular ejection fraction (LVEF) < 50%
- NYHA class I-III
- Is expected to have high degree of ventricular pacing (close to 100%)
- Correctable causes of congestive heart failure (e.g., ischemia, tachycardia-mediated cardiomyopathy) have been appropriately addressed
*In this context, an adequate trial of guideline-directed medical therapy means either 3 months of therapy following diagnosis or 40 days of therapy following the most recent myocardial infarction.
CRT-P or CRT-D is considered medically necessary for patients whose current device has reached generator end-of-life criteria.
Rationale
Much of the relevant data regarding the clinical utility of CRT are from several clinical trials published between 2002 and 2010, including MIRACLE, COMPANION, CARE-HF, REVERSE, MADIT-CRT, and RAFT. Among patients with heart failure, these studies have shown reductions in death and hospitalization for heart failure with CRT. Guideline criteria are based on the inclusion criteria for these studies and are in concordance with professional society guidelines.13
References
- Abraham WT, Fisher WG, Smith AL, et al. Cardiac resynchronization in chronic heart failure. N Engl J Med. 2002;346(24):1845-53.
- Brignole M, Botto G, Mont L, et al. Cardiac resynchronization therapy in patients undergoing atrioventricular junction ablation for permanent atrial fibrillation: a randomized trial. European heart journal. 2011;32(19):2420-9.
- Bristow MR, Saxon LA, Boehmer J, et al. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004;350(21):2140-50.
- Bryant AR, Wilton SB, Lai MP, et al. Association between QRS duration and outcome with cardiac resynchronization therapy: a systematic review and meta-analysis. Journal of electrocardiology. 2013;46(2):147-55.
- Chen JS, Niu XW, Chen FM, et al. Etiologic impact on difference on clinical outcomes of patients with heart failure after cardiac resynchronization therapy: A systematic review and meta-analysis. Medicine (Baltimore). 2018;97(52):e13725.
- Cleland JG, Abraham WT, Linde C, et al. An individual patient meta-analysis of five randomized trials assessing the effects of cardiac resynchronization therapy on morbidity and mortality in patients with symptomatic heart failure. European heart journal. 2013;34(46):3547-56.
- Curtis AB, Worley SJ, Adamson PB, et al. Biventricular pacing for atrioventricular block and systolic dysfunction. N Engl J Med. 2013;368(17):1585-93.
- Epstein AE, Dimarco JP, Ellenbogen KA, et al. ACC/AHA/HRS 2008 guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: executive summary. Heart rhythm. 2008;5(6):934-55.
- 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.
- Exner DV, Birnie DH, Moe G, et al. Canadian Cardiovascular Society guidelines on the use of cardiac resynchronization therapy: evidence and patient selection. The Canadian journal of cardiology. 2013;29(2):182-95.
- Gasparini M, Leclercq C, Lunati M, et al. Cardiac resynchronization therapy in patients with atrial fibrillation: the CERTIFY study (Cardiac Resynchronization Therapy in Atrial Fibrillation Patients Multinational Registry). JACC Heart Fail. 2013;1(6):500-7.
- Glikson M, Nielsen JC, Kronborg MB, et al. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: Developed by the Task Force on cardiac pacing and cardiac resynchronization therapy of the European Society of Cardiology (ESC) With the special contribution of the European Heart Rhythm Association (EHRA). Rev Esp Cardiol (Engl). 2022;75(5):430.
- 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. Journal of the American College of Cardiology. 2022;79(17):e263-e421.
- Khairy P, Van Hare GF, Balaji S, et al. PACES/HRS expert consensus statement on the recognition and management of arrhythmias in adult congenital heart disease: developed in partnership between the Pediatric and Congenital Electrophysiology Society (PACES) and the Heart Rhythm Society (HRS). Endorsed by the governing bodies of PACES, HRS, the American College of Cardiology (ACC), the American Heart Association (AHA), the European Heart Rhythm Association (EHRA), the Canadian Heart Rhythm Society (CHRS), and the International Society for Adult Congenital Heart Disease (ISACHD). Canadian Journal of Cardiology. 2014;30(10):e1-e63.
- Knuuti J, Wijns W, Saraste A, et al. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. European heart journal. 2019.
- Leclercq C, Walker S, Linde C, et al. Comparative effects of permanent biventricular and right-univentricular pacing in heart failure patients with chronic atrial fibrillation. European heart journal. 2002;23(22):1780-7.
- McDonagh TA, Metra M, Adamo M, et al. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. European heart journal. 2021;42(36):3599-726.
- Moss AJ, Hall WJ, Cannom DS, et al. Cardiac-resynchronization therapy for the prevention of heart-failure events. N Engl J Med. 2009;361(14):1329-38.
- Parkash R, Philippon F, Shanks M, et al. Canadian Cardiovascular Society guidelines on the use of cardiac resynchronization therapy: implementation. The Canadian journal of cardiology. 2013;29(11):1346-60.
- Priori SG, Blomstrom-Lundqvist C, Mazzanti A, et al. 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC). European heart journal. 2015;36(41):2793-867.
- Ruschitzka F, Abraham WT, Singh JP, et al. Cardiac-resynchronization therapy in heart failure with a narrow QRS complex. N Engl J Med. 2013;369(15):1395-405.
- Russo AM, Stainback RF, Bailey SR, et al. ACCF/HRS/AHA/ASE/HFSA/SCAI/SCCT/SCMR 2013 appropriate use criteria for implantable cardioverter-defibrillators and cardiac resynchronization therapy: a report of the American College of Cardiology Foundation appropriate use criteria task force, Heart Rhythm Society, American Heart Association, American Society of Echocardiography, Heart Failure Society of America, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance. Heart rhythm. 2013;10(4):e11-58.
- Santangeli P, Di Biase L, Pelargonio G, et al. Cardiac resynchronization therapy in patients with mild heart failure: a systematic review and meta-analysis. Journal of Interventional Cardiac Electrophysiology. 2011;32(2):125-35.
- Stavrakis S, Garabelli P, Reynolds DW. Cardiac resynchronization therapy after atrioventricular junction ablation for symptomatic atrial fibrillation: a meta-analysis. Europace. 2012;14(10):1490-7.
- Steffel J, Robertson M, Singh JP, et al. The effect of QRS duration on cardiac resynchronization therapy in patients with a narrow QRS complex: a subgroup analysis of the EchoCRT trial. European heart journal. 2015;36(30):1983-9.
- Upadhyay GA, Choudhry NK, Auricchio A, et al. Cardiac resynchronization in patients with atrial fibrillation: a meta-analysis of prospective cohort studies. Journal of the American College of Cardiology. 2008;52(15):1239-46.
- Wilton SB, Leung AA, Ghali WA, et al. Outcomes of cardiac resynchronization therapy in patients with versus those without atrial fibrillation: a systematic review and meta-analysis. Heart rhythm. 2011;8(7):1088-94.
- Zareba W, Klein H, Cygankiewicz I, et al. Effectiveness of Cardiac Resynchronization Therapy by QRS Morphology in the Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy (MADIT-CRT). Circulation. 2011;123(10):1061-72.
- Zusterzeel R, Selzman KA, Sanders WE, et al. Cardiac resynchronization therapy in women: US Food and Drug Administration meta-analysis of patient-level data. JAMA internal medicine. 2014;174(8):1340-8.
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.
00530 | Anesthesia for permanent transvenous pacemaker insertion |
00534 | Anesthesia for transvenous insertion or replacement of pacing cardioverter/defibrillator |
33208 | Insertion of new or replacement of permanent pacemaker with transvenous electrode(s); atrial and ventricular |
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) |
33221 | Insertion of pacemaker pulse generator only; with existing multiple leads |
33224 | Insertion of pacing electrode, cardiac venous system, for left ventricular pacing; with attachment to previously placed pacemaker or implantable defibrillator pulse generator (including revision of pocket, removal, insertion, and/or replacement of existing generator) |
33225 | Insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of implantable defibrillator or pacemaker pulse generator (eg, for upgrade to dual chamber system) (List separately in addition to code for primary procedure) |
33226 | Repositioning of previously implanted cardiac venous system (left ventricular) electrode (including removal, insertion and/or replacement of existing generator) |
33229 | Removal of permanent pacemaker pulse generator with replacement of pacemaker pulse generator; multiple lead system |
33241 | Removal of implantable defibrillator pulse generator only |
33243 | Removal of single or dual chamber pacing cardioverter-defibrillator electrode(s); by thoracotomy |
33244 | Removal of single or dual chamber pacing cardioverter-defibrillator electrode(s); by transvenous extraction |
33249 | Insertion or replacement of permanent implantable defibrillator system, with transvenous lead(s), single or dual chamber |
33263 | Removal of implantable defibrillator pulse generator with replacement of implantable defibrillator pulse generator; dual lead system |
33264 | Removal of implantable defibrillator pulse generator with replacement of implantable defibrillator pulse generator; multiple lead system |
93641 | Electrophysiologic evaluation of single or dual chamber pacing cardioverter-defibrillator leads including defibrillation threshold evaluation (induction of arrhythmia evaluation of sensing and pacing for arrhythmia termination) at time of initial implantation or replacement; with testing of single or dual chamber pacing cardioverter-defibrillator pulse generator |
G0448 | Insertion or replacement of a permanent pacing cardioverter-defibrillator system with transvenous lead(s), single or dual chamber with insertion of pacing electrode, cardiac venous system, for left ventricular pacing |
History
Status | Review Date | Effective Date | Action |
|---|---|---|---|
| Archived | n/a | 03/17/2024 | Not to be used for dates of service on or after 03/17/2024. |
Revised/ Updated | 05/09/2022, 01/23/2024 | 04/09/2023 | Independent Multispecialty Physician Panel (IMPP) review. Rephrased criteria around prolonged QRS duration for clarity. Updated references. Expanded guideline rationale. Added required language per new Medicare regulations. Added CPT code 33221. Removed C1824. |
Revised | 05/26/2021 | 11/07/2021 | IMPP review. Added indication for device replacement when generator end-of-life criteria are present. |
Updated | 08/26/2020 | 01/01/2021 | Original effective date. Updated code set. |
Revised | 05/14/2020 | – | Replaced “optimal” with “guideline directed” and moved note in CRT-P. |
Reviewed | 05/11/2019 | – | IMPP review. |