Medicare program; removal of the requirements for the cardiac pacemaker registry. Health Care Financing Administration, HHS. Final rule.
This final rule eliminates all requirements and references regarding the Cardiac Pacemaker Registry (the Registry) in our regulations. It conforms to the Food and Drug Adminstration's (FDA) recent final rule that required any physician and any provider of services who requests or receives Medicare payment for the implantation, removal, or replacement of permanent cardiac pacemaker devices and pacemaker leads to submit certain information to the Registry.  We used the information to administer Medicare payment for these devices. This rule implements an Act to Repeal An Unnecessary Medical Device Reporting Requirement passed by Congress to eliminate duplicative and unnecessary reporting.
D014487:Centers for Medicare and Medicaid Services, U.S.; D017147:Defibrillators, Implantable / Q000592:standards*; D006801:Humans; D006278:Medicare; D012042:Registries / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration