Code of Federal Regulations (Last Updated: May 6, 2024) |
Title 42 - Public Health |
Chapter IV - Centers for Medicare & Medicaid Services, Department of Health and Human Services |
SubChapter B - Medicare Program |
Part 405 - Federal Health Insurance for the Aged and Disabled |
Subpart B - Medical Services Coverage Decisions That Relate to Health Care Technology |
§ 405.205 - Coverage of a Category B (Nonexperimental/investigational) device.
Latest version.
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§ 405.205 Coverage of a Category B (Nonexperimental/investigational) device.
(a) For any device that meets the requirements of the exception at § 411.15(o) of this chapter, the following procedures apply:
(1) The FDA notifies CMS, when it notifies the sponsor, that the device is categorized by FDA as Category B (Nonexperimental/investigational).
(2) CMS uses the categorization of the device as a factor in making Medicare coverage decisions.
(b) If the FDA becomes aware that a categorized device no longer meets the requirements of the exception at § 411.15(o) of this chapter, the FDA notifies the sponsor and CMS and the procedures described in paragraph (a)(2) of this section apply.
[60 FR 48423, Sept. 19, 1995, as amended at 78 FR 74809, Dec. 10, 2013