§ 805.1 - Scope.

(a) This part provides for a nationwide cardiac pacemaker registry and requires any physician and any provider of services who requests or receives payment from Medicare for the implantation, removal, or replacement of permanent cardiac pacemakers and pacemaker leads to submit certain information to the registry. If the physician or the provider of services does not submit the information according to this part and 42 CFR 409.19(a) and 410.64(a), HCFA, which administers the Medicare program, will deny payment to the physician or the provider. FDA will use the information submitted to the registry to track the performance of permanent pacemakers and pacemaker leads and to perform studies and analyses regarding the use of the devices, and to transmit data to HCFA to assist HCFA in administering the Medicare program and to other Department of Health and Human Services’ components to carry out statutory responsibilities.

(b) Information submitted to the registry by a physician or a provider of services (and any release by FDA or HCFA of that information) does not necessarily reflect a conclusion by the submitter, FDA, or HCFA that the information constitutes an admission that a pacemaker device or lead failed to operate within its performance specifications. A submitter need not admit, and may deny, that the information submitted to the registry constitutes an admission that the pacemaker device or lead failed to operate within its performance specifications.

(c) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.