Medicare Program; Removal of the Requirements for the Cardiac Pacemaker Registry
fda-device · Food and Drug Administration · Rule · Published 2000-10-19 · Effective 2000-10-19 · 65 FR 62645
Document
Document number
00-26282
Federal Register citation
65 FR 62645
CFR reference
42 CFR 409
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2000-10-19
Effective date
2000-10-19
HHS docket
HCFA-3045-F
Abstract
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 Administration'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.