Economics and Reimbursement Information for ICDs

Cost Effectiveness of ICD Therapy

Cost of Treatment with an ICD

Research shows that ICDs provide an invaluable form of life insurance for people most at risk, preventing SCA death 98% of the time.¹ Evidence-based medicine has demonstrated that ICDs significantly reduce death among Americans at highest risk:

• 31% reduction in death among SCA survivors from a second event.²
• 31% reduction in death among post-heart attack sufferers.³
• 23% reduction in death among heart failure patients⁴

Despite these statistics, ICDs are underutilized.

• Fewer than 20% of currently indicated patients receive the benefits of an ICD despite being at high risk for sudden death.
• Although SCA is responsible for more deaths than breast cancer, lung cancer and HIV/AIDS combined, spending on SCA prevention is modest when compared to other diseases.
• AIDS: $19.5 billion, lung cancer $1.6 billion, breast cancer: $0.8 billion.⁵
• SCA: $2.4 billion (including drug and device therapy).⁶

The value of ICDs outweighs their cost to the system

• An ICD costs approximately $25,000 (including implant costs), which equates to less than $10 per day over the average life of a device (seven years).^{6, 7}
• The cost per day of ICD protection has decreased by nearly 90% over the last 10 years from more than $90 in 1990 to less than $10 today (equivalent to the cost of optimal medical therapy for these same patients).⁸
• ICD Medicare expenditures are significantly less than for other cardiovascular procedures. In 2002, Medicare reimbursed $1.2 billion for ICD procedures vs. $6.4 billion for stent implants and $7.8 billion for bypass surgery.⁵
• The cost of ICD therapy per year is less than 0.2% of projected Medicare spending over the next 10 years.¹⁰

  (click chart to enlarge)

• Many common cardiovascular interventions performed today exceed what is considered cost effective.

  (click chart to enlarge)

• This graph shows the results of recent studies that have been published on device cost-effectiveness. Overall, the results demonstrate CRT and ICD are cost-effective therapies regardless of the clinical indication for use. In addition, CRT and ICD therapies have a cost-effective profile that is below generally accepted benchmarks for cardiovascular therapies.

CMS ICD Reimbursement

1. Documented episode of cardiac arrest due to ventricular fibrillation (VF), not due to a transient or reversible cause
2. Documented sustained ventricular tachyarrhythmia (VT), either spontaneous or induced by an electrophysiology (EP) study, not associated with an acute myocardial infarction (MI) and not due to a transient or reversible cause
3. Documented familial or inherited conditions with a high risk of life-threatening VT, such as long QT syndrome or hypertrophic cardiomyopathy
4. Coronary artery disease with a documented prior MI, a measured left ventricular ejection fraction (LVEF) ≤ 0.35, and inducible, sustained VT or VF at EP study. (The MI must have occurred more than 4 weeks prior to defibrillator insertion. The EP test must be performed more than 4 weeks after the qualifying MI.)
5. Documented prior MI and a measured LVEF ≤ 0.30. Patients must not have: NYHA Class IV HF; Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm; Had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within past 3 months; Had an MI within past 40 days
6. Patients with ischemic dilated cardiomyopathy (IDCM), prior MI, NYHA Class II & III heart failure, LVEF ≤ 35%
7. Patients with non-ischemic dilated cardiomyopathy (NIDCM) > 3 months, NYHA Class II & III heart failure, LVEF ≤ 35%
8. Patients who meet all current CMS coverage requirements for a cardiac resynchronization therapy (CRT) device and have NYHA Class IV heart failure