Status: Updated Effective Date: 09/10/2023
Doc ID: CAR06-0923.1 Last Review Date: 05/26/2021
Clinical Appropriateness Guidelines
© 2023 Carelon Medical Benefits Management, Inc. All rights reserved.
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.
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.
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.
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
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.
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® (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.
Anesthesia for transvenous insertion or replacement of pacing cardioverter-defibrillator
Insertion or replacement of implantable cardioverter-defibrillator system with substernal electrode(s), including all imaging guidance and electrophysiological evaluation (includes defibrillation threshold evaluation, arrhythmia termination, and programming or reprogramming of sensing or therapeutic parameters, when performed
Insertion of substernal implantable defibrillator electrode
Removal of substernal implantable defibrillator electrode
Repositioning of previously implanted substernal implantable defibrillator-pacing electrode
Insertion of epicardial electrode(s); open incision (eg, thoracotomy, median sternotomy, subxiphoid approach)
Insertion of epicardial electrode(s); endoscopic approach (eg, thoracoscopy, pericardioscopy)
Repositioning of previously implanted transvenous pacemaker or implantable defibrillator (right atrial or right ventricular) electrode
Insertion of a single transvenous electrode, permanent pacemaker or implantable defibrillator
Insertion of 2 transvenous electrodes, permanent pacemaker or implantable defibrillator
Repair of single transvenous electrode, permanent pacemaker or implantable defibrillator
Repair of 2 transvenous electrodes for permanent pacemaker or implantable defibrillator
Relocation of skin pocket for implantable defibrillator
Insertion of implantable defibrillator pulse generator only; with existing dual leads
Insertion of implantable defibrillator pulse generator only; with existing multiple leads
Insertion of implantable defibrillator pulse generator only; with existing single lead
Removal of implantable defibrillator pulse generator only
Removal of single or dual chamber implantable defibrillator electrode(s); by thoracotomy
Removal of single or dual chamber implantable defibrillator electrode(s); by transvenous extraction
Insertion or replacement of permanent implantable defibrillator system with transvenous lead(s), single or dual chamber
Removal of pacing cardioverter-defibrillator pulse generator with replacement of pacing cardioverter-defibrillator pulse generator; single lead system
Removal of pacing cardioverter-defibrillator pulse generator with replacement of pacing cardioverter-defibrillator pulse generator; dual lead system
Removal of pacing cardioverter-defibrillator pulse generator with replacement of pacing cardioverter-defibrillator pulse generator; multiple lead system
Insertion or replacement of permanent subcutaneous implantable defibrillator system, with subcutaneous electrode, including defibrillation threshold evaluation, induction of arrhythmia, evaluation of sensing for arrhythmia termination, and programming or reprogramming of sensing or therapeutic parameters, when performed
Insertion of subcutaneous implantable defibrillator electrode
Removal of subcutaneous implantable defibrillator electrode
Repositioning of previously implanted subcutaneous implantable defibrillator electrode
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
Removal of implantable defibrillator pulse generator only
Cardioverter-defibrillator, dual chamber (implantable)
Cardioverter-defibrillator, single chamber (implantable)
Lead, cardioverter-defibrillator, endocardial single coil (implantable)
Cardioverter-defibrillator, other than single or dual chamber (implantable)
Lead, cardioverter-defibrillator, endocardial dual coil (implantable)
Lead, cardioverter-defibrillator, other than endocardial single or dual coil (implantable)
Lead, pacemaker/cardioverter-defibrillator combination (implantable)
This guideline addresses the appropriate clinical indications for transvenous and subcutaneous implantable cardioverter defibrillators (ICDs) for management of ventricular arrhythmia. Use of external defibrillators and cardiac resynchronization devices is not addressed in this document.
Guideline-directed medical therapy (GDMT): Maximum tolerated doses of appropriately titrated medication (to include beta blockers, ACE inhibitors or ARBs, aldosterone antagonists and diuretics in patients with left ventricular dysfunction). When a particular medication class is contraindicated, GDMT definition can exclude that class.
Sustained ventricular tachycardia: Ventricular tachycardia that persists for at least 30 seconds or requiring termination due to hemodynamic instability.
Structural heart disease: Left ventricular dysfunction (LVEF < 50%), prior myocardial infarction, moderate or severe valvular heart disease or complex congenital heart disease.
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.
Transvenous ICD placement is considered medically necessary in ANY of the following scenarios when survival with good functional status for more than one year is anticipated:
- Following cardiac arrest due to ventricular fibrillation or tachycardia when no completely reversible cause can be identified
- Spontaneous sustained ventricular tachycardia in an individual with structural heart disease
- Syncope which is otherwise unexplained in an individual with structural heart disease
- Syncope which is otherwise unexplained in an individual with ischemic heart disease and inducible sustained monomorphic ventricular tachycardia on electrophysiology (EP) study
- Nonischemic dilated cardiomyopathy when, following 90 days of GDMT, BOTH of the following are still present:
- Left ventricular ejection fraction (LVEF) ≤ 35%
- NYHA functional class II or III
- Ischemic cardiomyopathy when ANY of the following apply:
- LVEF is ≤ 30% due to myocardial infarction ≥ 40 days previously in an individual with NYHA functional class I despite GDMT, who is at least 90 days post revascularization (if revascularization has been performed)
- LVEF is ≤ 35% due to myocardial infarction ≥ 40 days previously in an individual with NYHA functional class II or III despite GDMT, who is at least 90 days post revascularization (if revascularization has been performed)
- LVEF is ≤ 40% due to prior myocardial infarction in an individual who has spontaneous nonsustained ventricular tachycardia AND positive electrophysiology study performed ≥ 96 hours following myocardial infarction
- Congenital heart disease when ANY of the following apply:
- History of cardiac arrest thought to be (or known to be) due to ventricular arrhythmia
- Ventricular tachycardia with hemodynamic instability not amenable to other treatment options (e.g., surgical repair, ablation) and following institution of GDMT for ventricular dysfunction (if present)
- Unexplained syncope in an individual with repaired congenital heart disease who has moderate LV dysfunction (LVEF < 40%) or marked left ventricular hypertrophy
- Established diagnosis of hypertrophic cardiomyopathy when ANY of the following apply:
- History of cardiac arrest thought to be (or known to be) due to ventricular arrhythmia in the absence of reversible cause
- Syncope or hemodynamic compromise known to be related to ventricular tachycardia
- Maximum LV wall thickness ≥ 30 mm
- Sudden cardiac death presumed related to hypertrophic cardiomyopathy in a first-degree relative
- Unexplained syncope within the preceding 6 months
- Abnormal blood pressure response to exercise or spontaneous nonsustained ventricular tachycardia in an individual who has ANY of the following:
- Age < 30 years
- Delayed hyperenhancement on cardiac MRI
- Left ventricular outflow tract obstruction
- Syncope within the preceding 5 years
- Left ventricular aneurysm
- Left ventricular ejection fraction < 50%
- Established diagnosis of arrhythmogenic right ventricular dysplasia when ANY of the following apply:
- History of cardiac arrest
- Sustained ventricular tachycardia
- Left and/or right ventricular ejection fraction ≤ 35% in an individual who is on GDMT
- Syncope thought to be (or known to be) due to ventricular arrhythmia
- Established diagnosis of long QT syndrome in an individual with syncope or ventricular tachycardia despite beta blocker therapy (or in whom beta blockers are contraindicated)
- Established diagnosis of short QT syndrome in an individual who has a history of cardiac arrest or sustained ventricular tachycardia or fibrillation
- Established diagnosis of Brugada syndrome in an individual with spontaneous type 1 electrocardiographic pattern when ANY of the following apply:
- History of cardiac arrest
- Sustained ventricular tachycardia or ventricular fibrillation
- History of syncope thought to be (or known to be) due to ventricular arrhythmia
- Catecholaminergic polymorphic ventricular tachycardia in an individual with recurrent sustained ventricular tachycardia or recurrent syncope despite beta blocker therapy (or in whom beta blockers are contraindicated)
- Established diagnosis of cardiac sarcoidosis when ANY of the following apply:
- History of cardiac arrest
- LVEF ≤ 35% in an individual who is on GDMT
- Spontaneous or induced sustained ventricular tachycardia
- Indication for permanent pacemaker
- LVEF > 35% with history of syncope or evidence of extensive myocardial scar by cardiac MRI or PET scan
- An outpatient who has met criteria for, and is awaiting, heart transplant or ventricular assist device and who is NYHA functional class IV
- Device replacement when generator end-of-life criteria are present
Subcutaneous ICD placement is considered medically necessary when ALL of the following criteria are met:
- ONE of the above criteria for transvenous ICD placement is present
- The individual does not require pacing for bradycardia, overdrive pacing for termination of ventricular tachycardia, or cardiac resynchronization
- The individual does not have incessant ventricular tachycardia
- At least ONE of the following applies:
- Inability to secure venous access
- Immunocompromised individual
- Individual with recurrent transvenous lead-related, device-pocket, or systemic infections
- Individual with endocarditis
- Al-Khatib SM, Fonarow GC, Joglar JA, et al. Primary Prevention Implantable Cardioverter Defibrillators in Patients With Nonischemic Cardiomyopathy: A Meta-analysis. JAMA cardiology. 2017;2(6):685-8.
- Al-Khatib SM, Hellkamp A, Curtis J, et al. Non-evidence-based ICD implantations in the United States. JAMA. 2011;305(1):43-9.
- Al-Khatib SM, Stevenson WG, Ackerman MJ, et al. 2017 AHA/ACC/HRS guideline for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: Executive summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Heart rhythm. 2018;15(10):e190-e252.
- Bennett M, Parkash R, Nery P, et al. Canadian Cardiovascular Society/Canadian Heart Rhythm Society 2016 Implantable Cardioverter-Defibrillator Guidelines. The Canadian journal of cardiology. 2017;33(2):174-88.
- Burke MC, Gold MR, Knight BP, et al. Safety and Efficacy of the Totally Subcutaneous Implantable Defibrillator: 2-Year Results From a Pooled Analysis of the IDE Study and EFFORTLESS Registry. Journal of the American College of Cardiology. 2015;65(16):1605-15.
- Colquitt JL, Mendes D, Clegg AJ, et al. Implantable cardioverter defibrillators for the treatment of arrhythmias and cardiac resynchronisation therapy for the treatment of heart failure: systematic review and economic evaluation. Health technology assessment (Winchester, England). 2014;18(56):1-560.
- ECRI Institute. Subcutaneous implantable cardioverter defibrillator for treating life-threatening ventricular tachyarrhythmia. Plymouth Meeting, PA: ECRI Institute; 2016.
- Estes NA, 3rd. Clinical Outcomes of Patients Who Received the Subcutaneous Implantable Cardioverter Defibrillator. JAMA cardiology. 2016;1(8):965.
- Gersh BJ, Maron BJ, Bonow RO, et al. 2011 ACCF/AHA guideline for the diagnosis and treatment of hypertrophic cardiomyopathy: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. The Journal of thoracic and cardiovascular surgery. 2011;142(6):e153-203.
- Golwala H, Bajaj NS, Arora G, et al. Implantable Cardioverter-Defibrillator for Nonischemic Cardiomyopathy: An Updated Meta-Analysis. Circulation. 2017;135(2):201-3.
- Kober L, Thune JJ, Nielsen JC, et al. Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure. The New England journal of medicine. 2016;375(13):1221-30.
- Kusumoto FM, Calkins H, Boehmer J, et al. HRS/ACC/AHA expert consensus statement on the use of implantable cardioverter-defibrillator therapy in patients who are not included or not well represented in clinical trials. Journal of the American College of Cardiology. 2014;64(11):1143-77.
- Monnig G, Kobe J, Loher A, et al. Role of implantable cardioverter defibrillator therapy in patients with acquired long QT syndrome: a long-term follow-up. Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology. 2012;14(3):396-401.
- National Institute for Health and Care Excellence NICE cg454. Insertion of a subcutaneous implantable cardioverter defibrillator for prevention of cardiac death. London (UK): National Institute for Health and Care Excellence; 2013.
- Olde Nordkamp LR, Postema PG, Knops RE, et al. Implantable cardioverter-defibrillator harm in young patients with inherited arrhythmia syndromes: A systematic review and meta-analysis of inappropriate shocks and complications. Heart rhythm. 2016;13(2):443-54.
- 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.
- 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.
- Shen WK, Sheldon RS, Benditt DG, et al. 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. Heart rhythm. 2017;14(8):e155-e217.
- Sieira J, Ciconte G, Conte G, et al. Asymptomatic Brugada Syndrome: Clinical Characterization and Long-Term Prognosis. Circulation Arrhythmia and electrophysiology. 2015;8(5):1144-50.
- Steinbeck G, Andresen D, Seidl K, et al. Defibrillator implantation early after myocardial infarction. The New England journal of medicine. 2009;361(15):1427-36.
- Uhlig K, Balk EM, Earley A, et al. AHRQ Technology Assessments. Assessment on Implantable Defibrillators and the Evidence for Primary Prevention of Sudden Cardiac Death. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013.
- Yancy CW, Jessup M, Bozkurt B, et al. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. Journal of cardiac failure. 2017;23(8):628-51.
Added HCPCS C1899.
Independent Multispecialty Physician Panel (IMPP) review. Added indication for device replacement when generator end-of-life criteria are present.
Original effective date. Updated code set.
Literature review. Added CPT code 0571T.