Title 42

PART 405 SUBPART B

Subpart B - Medical Services Coverage Decisions That Relate to Health Care Technology Authority:Secs. 1102, 1862 and 1871 of the Social Security Act as amended (42 U.S.C.1302, 1395y, and 1395hh). Source:60 FR 48423, Sept. 19, 1995, unless otherwise noted.

• Authority: 42 U.S.C. 263a, 405(a), 1302, 1320b-12, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk, 1395rr, and 1395ww(k).
• Source:

42:2.0.1.2.6.2.21.1	SECTION 405.201	405.201 Scope of subpart and definitions.
42:2.0.1.2.6.2.21.2	SECTION 405.203	405.203 FDA categorization of investigational devices.
42:2.0.1.2.6.2.21.3	SECTION 405.205	405.205 Coverage of a Category B (Nonexperimental/investigational) device.
42:2.0.1.2.6.2.21.4	SECTION 405.207	405.207 Services related to a noncovered device.
42:2.0.1.2.6.2.21.5	SECTION 405.209	405.209 Payment for a Category B (Nonexperimental/investigational) device.
42:2.0.1.2.6.2.21.6	SECTION 405.211	405.211 Coverage of items and services in FDA-approved IDE studies.
42:2.0.1.2.6.2.21.7	SECTION 405.212	405.212 Medicare Coverage IDE study criteria.
42:2.0.1.2.6.2.21.8	SECTION 405.213	405.213 Re-evaluation of a device categorization.
42:2.0.1.2.6.2.21.9	SECTION 405.215	405.215 Confidential commercial and trade secret information.

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