Medicare has specified a “desire to ensure that defibrillator implantation only occurs in those patients who are most likely to benefit and that the procedures are done only by competent providers in facilities with a history of good outcomes and a quality assessment/improvement program to identify providers with poor outcomes and other areas for improvement.” Medicare noted it is “concerned that the available evidence does not allow providers to target these devices to patients who will clearly derive benefit.” Therefore, Medicare “will require that reimbursement for [implantable cardioverter defibrillator] ICDs for primary prevention of sudden cardiac death occur only if the beneficiary receiving the defibrillator implantation is enrolled in either an FDA-approved category B Investigational Device Exemption clinical trial or a qualifying national database (registry).” (See Rationale section.) Because of the Medicare reimbursement policy, ICD placement may require out-of-network referral.
A totally subcutaneous ICD (S-ICD®) has also been developed.These are derived from nonrandomized studies, extrapolation from adult clinical trials, and expert consensus.Effective in 2015, the CPT coding for these devices was updated to include insertion of subcutaneous ICD devices (see Code Table) State or federal mandates (e.g., FEP) may dictate that all devices approved by the U. Food and Drug Administration (FDA) may not be considered investigational, and thus these devices may be assessed only on the basis of their medical necessity.Regulatory Status FDA has approved a large number of ICDs through the PMA process (FDA product code: LWS).A 2014 review of FDA approvals of cardiac implantable devices reported that between 19, FDA approved 19 ICDs (7 pulse generators, 3 leads, 9 combined systems) through new PMA applications.(1) Many originally-approved ICDs have undergone multiple supplemental applications.
Single chamber icd implant cpt code
The first ICD TEC Assessment, published in 2002, addressed this indication.(2) The Assessment focused on the Multicenter Automatic Defibrillator Implantation Trials (known as MADIT I and MADIT II) that compared the use of an ICD with conventional therapy among patients with coronary artery disease with a prior history of myocardial infarction (MI) and a current history of a reduced ejection fraction.The key difference in the 2 trials was the patient selection criteria.Overview and Summary of TEC Assessments Automatic implantable cardiac defibrillators (ICDs) were first used in survivors of near sudden cardiac death.There has been ongoing interest in using ICDs as primary preventive therapy in patients with risk factors for sudden cardiac death.The electrodes sense the cardiac rhythm and deliver countershocks through the subcutaneous tissue of the chest wall. FDA-labeled indications generally include patients who have experienced life-threatening VT associated with cardiac arrest or VT associated with hemodynamic compromise and resistance to pharmacologic treatment.
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Devices manufactured by Guidant are approved by FDA for use “in patients at high risk of sudden cardiac death due to ventricular arrhythmias and who have experienced at least 1 of the following: an episode of cardiac arrest (manifested by the loss of consciousness) due to a ventricular tachyarrhythmia; recurrent, poorly tolerated sustained ventricular tachycardia (VT); or a prior myocardial infarction (MI) , left ventricular ejection fraction of less than or equal to 35%, and a documented episode of nonsustained VT, with an inducible ventricular tachyarrhythmia.” On July 18, 2002, FDA expanded the approved indications for the Guidant ICD devices to include the prophylactic use of Guidant ICDs for cardiac patients who have had a previous heart attack and have an ejection fraction that is 30% or less.
This policy was created in 1996 and updated periodically with literature review.
The most recent update with literature review covers the period through September 7, 2014.
This expanded indication is based on the results of the second Multicenter Automatic Defibrillator Implantation Trial (MADIT II trial), which is discussed here.
Medtronic devices are approved “to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.” Other devices have approval language similar to that of Medtronic.