1. Regulations
  2. title 42
  3. chapter IV
  4. part 405
  5. subpart B
  6. § 405.209

View all text of Subpart B [§ 405.201 - § 405.215]

§ 405.209 - Payment for a Category B (Nonexperimental/investigational) device.

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.

[78 FR 74809, Dec. 10, 2013]

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

CITE AS: 42 CFR 405.209