Are We Improving Care of Medicare Patients Undergoing Primary Prevention ICD Implantation?
Multiple clinical trials have demonstrated the benefit of implantable cardioverter-defibrillators (ICDs) for the primary prevention of sudden cardiac death in selected high-risk populations.1-5 Based on results of clinical trials and incorporation of evidence into practice guidelines, over 12,000 ICD implantation procedures are now performed each month in the United States.6 Following publication of the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), the Centers from Medicare and Medicaid Services (CMS) expanded coverage for implantation of primary prevention ICDs for Medicare beneficiaries. This was accompanied by the decision for coverage with evidence development, mandating that all implants in Medicare patients be recorded in a prospective registry, now the National Cardiovascular Data Registry (NCDR®), as a requirement for reimbursement. There has been increased focus related to potential use of this therapy outside criteria specified in selected clinical trials and the possibility of potential "over-use" of ICDs has also been raised, heightened by recent Department of Justice Investigations that included use of ICDs in situations where "gaps" in evidence exist.7 As ICD therapy is costly, the need to measure long-term outcome of patients receiving ICDs for primary prevention indications in an aging population has been recognized, allowing assessment of outcomes beyond the confines of randomized clinical trials.8
- Received July 26, 2014.
- Accepted August 1, 2014.