CMS delays start date for national implantable cardiac defibrillator policy
CMS recently pushed back the start date for Medicare Administrative Contractors (MAC) to expand coverage terms for patients in need of an implantable cardiac defibrillator (ICD) by one month. The agency released Transmittal 213 on February 15, announcing a delayed implementation date of March 26.
The policy update, which took effect in February 2018, involves a revised national coverage determination (NCD) that governs who is eligible to receive an ICD to treat life-threatening heart disorders such as ventricular tachycardia. CMS updated NCD 20.4 (implantable cardiac defibrillators) to widen eligibility parameters largely by removing the need for a patient to be enrolled in a clinical trial to attain coverage.
As noted in its original guidance, effective for claims submitted on or after February 15, 2018, CMS covers ICDs for the following patient indications:
- Patients with a personal history of sustained ventricular tachyarrhythmias (VT) or cardiac arrest due to ventricular fibrillation.
- Patients with a prior myocardial infarction and a measured left ventricular ejection fraction (LVEF) of less than or equal to 0.30.
- Patients who have severe ischemic dilated cardiomyopathy but no personal history of sustained VT or cardiac arrest due to ventricular fibrillation and have New York Heart Association (NYHA) Class II or III heart failure, LVEF less than or equal to 35%.
- Patients who have severe non-ischemic dilated cardiomyopathy but no personal history of cardiac arrest or sustained VTs, NYHA Class II or III heart failure, LVEF less than or equal to 35%, and been on optimal medical therapy for at least three months.
- Patients with documented familial or genetic disorders with a high risk of life-threatening tachyarrhythmias to include, but not limited to, long QT syndrome or hypertrophic cardiomyopathy.
- Patients with an existing ICD may receive an ICD replacement if it is required due to the end of battery life, elective replacement indicator, or device malfunction.
A shared decision-making encounter must occur between the patient and physician or non-physician practitioner using a decision tool on ICDs prior to the initial ICD implantation, according to CMS. Additional eligibility criteria for each of the six covered indications above are outlined in Section 20.4 of the Medicare NCD Manual and MLN Matters MM10865.
MACs are required to automatically recognize coverage for eligible patients beginning on March 26. After this date, providers should resubmit any claims that were denied on the grounds of the sunsetting coverage terms.