Cardiac pacemaker registry--FDA, HCFA. Final rule.

The Food and Drug Administration (FDA) and the Health Care Financing Administration (HCFA) are issuing jointly a final rule to establish a national cardiac pacemaker registry, as required by the Deficit Reduction Act of 1984. This action is based on a proposed rule that was published in the Federal Register of May 6, 1986 (51 FR 16792). The final rule requires that certain information be submitted to FDA for inclusion in the registry from physicians and providers of services requesting or receiving Medicare payment for an implantation, removal, or replacement of permanent cardiac pacemaker devices and pacemaker leads. The final rule permits HCFA to deny Medicare payment to physicians and providers who fail to submit the required information to the registry.