§405.209. Payment for a Category B (Nonexperimental/investigational) device.
42 C.F.R. § 405.209
Payment under Medicare for a Category B (Nonexperimental/investigational) device is based on, and may not exceed, the amount that would have been paid for a currently used device serving the same medical purpose that has been approved or cleared for marketing by the FDA.
Notes, amendments, and revision history
Amendments
[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
[78 FR 74809, Dec. 10, 2013]