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National Coverage Analysis (NCA)Proposed Decision Memo
# Implantable Cardioverter Defibrillators
CAG-00157R4
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## Decision Summary
1. The Centers for Medicare & Medicaid Services (CMS) has determined that the evidence is sufficient to conclude that the use of implantable cardioverter defibrillators (ICDs, also referred to as defibrillators) is reasonable and necessary for the treatment of illness or injury or to improve the functioning of a malformed body member under section 1862(a)(1)(A) of the Social Security Act.
CMS is finalizing relatively minimal changes to the ICD NCD from the 2005 reconsideration. We summarize the changes below and fully explain the changes in the Analysis section of the NCD decision memo.
- _Patient Criteria_
- Add cardiac magnetic resonance imaging (MRI) to the list of diagnostic imaging studies that can evaluate left ventricular ejection fraction (LVEF);
- Require patients who have severe non-ischemic dilated cardiomyopathy but no personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation to have been on optimal medical therapy (OMT) for at least 3 months;
- Require a patient shared decision making (SDM) interaction prior to ICD implantation for certain patients.
- _Additional Patient Criteria_
- Remove the Class IV heart failure requirement for cardiac resynchronization therapy (CRT).
- _Exceptions to Waiting Periods_
- Add an exception for patients meeting CMS coverage requirements for cardiac pacemakers, and who meet the criteria for an ICD;
- Add an exception for patients with an existing ICD and qualifying replacement.
- _Registry Requirement_
- End the data collection requirement.
We are finalizing changes to the 20.4 NCD that reflect the 2005 reconsideration as described below:
1. Covered Indications
1. Patients with a personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation. Patients must have demonstrated:
- An episode of sustained ventricular tachyarrhythmia, either spontaneous or induced by an electrophysiology (EP) study, not associated with an acute myocardial infarction and not due to a transient or reversible cause; or
- An episode of cardiac arrest due to ventricular fibrillation, not due to a transient or reversible cause.
2. Patients with a prior myocardial infarction and a measured left ventricular ejection fraction (LVEF) ≤ 0.30. Patients must not have:
- New York Heart Association (NYHA) classification IV heart failure;
- Had a coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) with angioplasty and/or stenting,
Coverage indications
Surgical procedures covered when deemed medically necessary by a licensed physician.
Coverage for outpatient procedures where the patient meets criteria for safe discharge.
Covered when the service meets Medicare's definition of medical necessity.
Applicable for patients with specified diagnoses as outlined in coverage criteria.
Used for primary and secondary prevention of sudden cardiac death in patients with structural heart disease.
Indicated for patients with history of ventricular arrhythmias or those at high risk.
Coverage is provided for specific health services that are deemed medically necessary based on established criteria.
The use of implantable cardioverter defibrillators (ICDs) is reasonable and necessary for the treatment of illness or injury.
ICDs are also indicated to improve the functioning of a malformed body member.
Cardiac MRI is covered to evaluate left ventricular ejection fraction (LVEF).
Patients with severe non-ischemic dilated cardiomyopathy must be on optimal medical therapy (OMT) for at least 3 months prior to treatment consideration.
Patients with a personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation.
Patients with a prior myocardial infarction and a measured left ventricular ejection fraction (LVEF) ≤ 0.30.
Limitations
Not covered for procedures deemed elective or not medically necessary.
Coverage limited to patients aged 18 and older.
Not covered for services rendered without prior authorization.
Limited to specific patient age groups as described in the policy.
Not covered for patients without a prior history of cardiac arrest or lethal arrhythmia.
Will not cover for patients with reversible causes of arrhythmia.
Services not deemed medically necessary will not be covered.
Certain frequency limits apply based on the type of service provided.
Class IV heart failure requirement for cardiac resynchronization therapy (CRT) has been removed.
Patients must have a patient shared decision making (SDM) interaction prior to ICD implantation.
Patients must not have New York Heart Association (NYHA) classification IV heart failure.
Patients must not have had a coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) with angioplasty and/or stenting.
Documentation requirements
Pre-operative clinical notes detailing necessity for surgery.
Post-operative documentation supporting complications or outcomes.
Clinical documentation supporting the medical necessity of the service.
Prior authorization documentation must be included when applicable.
Clinical notes must document the indication for ICD placement.
Prior authorization is required before implantation.
Clinical notes supporting medical necessity are required.
Prior authorization documentation must be submitted for review.
Patient must show evidence of optimal medical therapy (OMT) duration.
Documentation of shared decision making (SDM) interaction is required.
Codes in this policy
Code numbers and each code’s status as the policy records it. CPT code descriptions are left out of this page, as are the passages that cite CPT codes; the official document has them.
Backwork has no codes on record for this policy. Check the source.