Implantable Cardioverter-Defibrillators: Controversy and Coverage

Consider the following case. A 53-year-old woman is admitted for palpitations. She presents with severe presyncope and electrocardiography (ECG) is suggestive of Brugada syndrome, which becomes more evident with a procainamide infusion. There is observation of polymorphic ventricular tachycardia degenerating into ventricular fibrillation. Is ICD placement medically necessary for this patient? Yes.

But what about cases that are not as clear-cut? What about those cases in which an ICD is medically necessary but cannot be justified within the published criteria? According to the NCDR data presented at the 2010 Heart Rhythm Society by Dr. Al-Khatib and colleagues from Duke University, up to 20% of defibrillator implants do not meet the criteria set forth by the CMS. Currently, protocols do not exist for medically necessary implants that do not fall within the published criteria. Consider, for example, patients who have an indication for pacing post-MI and an EF ≤35%, but are not yet 40 days post-MI or 90 days post-revascularization. The situation for these patients remains unaddressed since the development of current guidelines and payment decisions were based only on populations included in the design of the clinical trials completed at the time, which excluded patients who had a proven indication for pacing.

As of 2010, the appropriate use of ICDs, especially in primary prevention, continues to undergo scrutiny by the CMS and its Recovery Audit Contractors (RACs) since the pool of eligible patients continues to grow. In addition, a number of hospitals have responded to requests from the US Department of Justice for records on patients who have received ICDs as far back as 2003. Insurers have also initiated programs for case reviews prior to device implantation.

The use of implantable cardioverter-defibrillators (ICDs) has steadily increased since 1985, when the US Food and Drug Administration (FDA) first approved ICDs. Once considered a treatment of last resort for patients surviving cardiac arrest, the indications for ICD implantation have evolved to include primary prevention for patients at a high risk for sudden cardiac death. The Centers for Medicare and Medicaid Services (CMS) expanded the indications for ICD to include primary prevention based on the results of the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) and the Multicenter Autonomic Defibrillator Implantation Trial II (MADIT-II).

The most recent evidence-based guidelines developed by the American College of Cardiology (ACC) and the American Association Heart Association (AHA), along with the American Association for Thoracic Surgery (AATS) and the Society of Thoracic Surgeons (STS), recommend ICD implantation as initial therapy in survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable ventricular tachycardia.[Epstein, 2008] These guidelines exclude cases in which there are “completely reversible causes.” The indications for ICD implantation as primary prophylaxis against sudden cardiac death (SCD) are classified as follows:

• ACC/AHA Class I
• Structural heart disease or sustained ventricular tachycardia (VT)
• Syncope of undetermined origin, inducible VT or ventricular fibrillation (VF) at electrophysiology study (EPS)
• A left ventricular ejection fraction (LVEF) <35% due to prior myocardial infarction (MI), at least 40 days post-MI, or New York Heart Association (NYHA) Class II or III
• Nonischemic dilated cardiomyopathy with an ejection fraction (EF) ≤35%
• LVEF ≤30% due to prior MI, at least 40 days post-MI
• LVEF <40% due to prior MI, inducible VT or VF at EPS
• ACC/AHA Class IIa
• Unexplained syncope, significant LV dysfunction, or non-ischemic cardiomyopathy (CM)
• Sustained VT or normal or near-normal ventricular function
• Hypertrophic CM with one or more major risk factors
• Arrhythmogenic right ventricular dysplasia/cardiomyopathy (ARVD/C) with one or more risk factors for sudden cardiac death
• Long QT syndrome, syncope or VT while receiving beta-blockers
• Nonhospitalized patients awaiting heart transplant
• Brugada syndrome and syncope
• Brugada syndrome and VT
• Catecholaminergic polymorphic VT, syncope or VT while receiving beta-blockers
• Cardiac sarcoidosis, giant cell myocarditis, or Chagas disease

Challenges are inevitable, especially since the coverage criteria lag behind emerging new data. For example, the recent Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) found that cardiac resynchronization therapy in combination with an ICD (CRT-ICD) was associated with a significant reduction in death or heart failure interventions when compared to the use of ICDs alone in patients with NYHA class I or II symptoms.[Moss, 2009] In addition, a recent meta-analysis suggests that women may not have the same survival advantage as men from a primary prevention device.[Ghanbari, 2009] How these findings will impact ICD implantation guidelines remains unknown until further studies are conducted. 

In this environment of increased activity and scrutiny, hospitals and physicians should be prepared to precisely document clinical qualifying events that consistently adhere to the ICD guidelines developed by the CMS, as well as those of the professional societies. Even as new data are incorporated into the guidelines and into the ICD registry, there will always be outlier cases. In reviewing these cases, hospitals not only need to consider the evolving medical evidence, but also must take into account any conflicts of interest involving friendships and/or competition among the members of the medical staff. External peer review facilitates the objective review of sensitive cases and allows for hospitals and physicians to honor their commitment to safe, timely, appropriate, and compliant care for every patient, while meeting the Joint Commission’s standards for ongoing peer review.

References

Epstein AE, DiMarco JP, Ellenbogen KA, et al. ACC/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices) developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. J Am Coll Cardiol. 2008;51(21):e1-62. 

Ghanbari H, Dalloul G, Hasan R, et al. Effectiveness of implantable cardioverter-defibrillators for the primary prevention of sudden cardiac death in women with advanced heart failure: A meta-analysis of randomized controlled trials. Arch Intern Med. 2009; 169:1500-1506.

Moss AJ, Hall WJ, Cannon DS, et al, for the MADIT-CRT Trial Investigators. Cardiac-resynchronization therapy for the prevention of heart-failure events. N Engl J Med. 2009;361:1329-1338.