§405.205. Coverage of a Category B (Nonexperimental/investigational) device.
42 C.F.R. § 405.205
For any device that meets the requirements of the exception at § 411.15(o) of this chapter, the following procedures apply:
The FDA notifies CMS, when it notifies the sponsor, that the device is categorized by FDA as Category B (Nonexperimental/investigational).
CMS uses the categorization of the device as a factor in making Medicare coverage decisions.
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.
Notes, amendments, and revision history
Amendments
[60 FR 48423, Sept. 19, 1995, as amended at 78 FR 74809, Dec. 10, 2013
Authority
Authority: Secs. 1102, 1862 and 1871 of the Social Security Act as amended (42 U.S.C.1302, 1395y, and 1395hh).
Source
Source: 60 FR 48423, Sept. 19, 1995, unless otherwise noted.
Authority
Authority: 42 U.S.C. 263a, 405(a), 1302, 1320b-12, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk, 1395rr, and 1395ww(k).
Amendments
[60 FR 48423, Sept. 19, 1995, as amended at 78 FR 74809, Dec. 10, 2013