Code of Federal Regulations Title 42. Public Health § 42.405.601 Medicare coverage of innovative technology

(a) Basis and scope. Medicare coverage of innovative technology (MCIT) is a program that provides national, time-limited coverage under section 1862(a)(1)(A) of the Act for certain breakthrough medical devices. Manufacturer participation in the pathway for breakthrough device coverage is voluntary.

(b) Definitions. For the purposes of this subpart, the following definitions are applicable:

Breakthrough device means a device that receives such designation by the Food and Drug Administration (FDA) (section 515B(d)(1) of the FD & C Act (21 U.S.C. 360e–3(d)(1)).

MCIT stands for Medicare coverage of innovative technology.