Last updated: July 2007
On January 27, 2005, The Centers for Medicare and Medicaid Services (CMS) announced its final decision to expand ICD coverage to thousands of patients at an elevated risk for sudden cardiac death. Based on overwhelming clinical evidence, CMS determined that lifesaving ICD therapy is reasonable and necessary for many more Medicare patients.
We are pleased that CMS has acted to significantly expand coverage of ICDs based on the best available scientific evidence. Included in the decision, CMS requires hospitals to report baseline information on ICD patients without documented ventricular tachycardia (VT) or ventricular fibrillation (VF). Beginning April 1, 2006, hospitals will use the ACC-NCDR® ICD Registry to report these data. This registry replaces the QNet system that was previously in place as a temporary data collection system.
| 1. | When do the new coverage indications go into effect? |
| January 27, 2005 | |
| 2. | In the decision summary, how is Section A different from Section B? |
| The sections are very similar. However, Section B defines coverage for patients with nonischemic dilated cardiomyopathy (NIDCM) 3-9 months. These patients are covered only if enrolled in a FDA Category B clinical trial or a future prospective data collection system. They are not covered by the interim data collection system (QNet). | |
| 3. | Does the decision require specific physician or hospital certification? |
| No. CMS does not require specific physician or hospital certification as a condition for reimbursement. However, CMS does strongly encourage credentialing and certification of physicians who insert ICDs by appropriate national organizations, such as the Heart Rhythm Society (HRS) or boards of medical specialties, to ensure the safety of Medicare beneficiaries. | |
| 4. | Does the CMS decision require that physicians use a specific ICD device type to treat patients? |
| No. Although CMS does not specifically exclude other types of devices, physicians and providers must be able to justify the medical necessity of devices other than single-lead devices. As always, this justification should be available in the patient medical record. | |
| 5. | Is CRT-D for Class IV patients now covered? |
| There is still no CMS national coverage determination for CRT. However, local Medicare contractors may now choose to provide CRT-D coverage for Class IV patients who also have a covered indication for an ICD. Previously, Class IV patients were only eligible for CRT-P technology. |
C5-183-1205