This device does not employ transvenous leads and thus avoids the need for venous access and complications associated with the venous leads.Rather, the S-ICD® uses a subcutaneous electrode that is implanted adjacent to the left sternum. Food and Drug Administration (FDA) through the premarket application approval process.The leads sense and transmit information on cardiac rhythm to the generator, which analyzes the rhythm information and produces an electrical shock when a malignant arrhythmia is recognized.A totally subcutaneous ICD (S-ICD®) has also been developed.
There has been ongoing interest in using ICDs as primary preventive therapy in patients with risk factors for sudden cardiac death.This policy was created in 1996 and updated periodically with literature review. Flirten mit polnischen frauen The most recent update with literature review covers the period through September 7, 2014.Therefore, the patient selection criteria of the MADIT II trial potentially identify a much larger number of candidates for ICD implantation.The 2002 TEC Assessment concluded, “For patients who have coronary artery disease with prior MI and reduced LVEF and who are similar to those selected in MADIT I and MADIT II, the available evidence demonstrates an improvement in overall mortality associated with ICD treatment compared with conventional therapy.” In October 2004, TEC reassessed ICDs.(3) The 2004 TEC Assessment focused on the results of the 5 randomized controlled trials (RCTs) included in the 2002 Assessment (including the Multicenter Unsustained Tachycardia Trial [MUSTT], MADIT I, MADIT II, Coronary Artery Bypass Graft [CABG] Patch Trial, and the Cardiomyopathy Trial [CAT]) and 5 additional RCTs: Further analysis of existing trial data using patient-level meta-analysis may further delineate which subgroups of patients are likely to benefit from ICD placement and those unlikely to benefit who can be spared the morbidity of ICD placement.
Single chamber icd implant cpt code
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.The use of a subcutaneous ICD is considered investigational for all indications in adult and pediatric patients.This policy addressed the use of ICD devices as stand-alone interventions, not as combination devices to treat heart failure (ie, cardiac resynchronization devices) or in combination with pacemakers.Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.
Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.
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.
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.
Plans may decide whether or not to encourage non-Medicare member participation in qualifying registries.