Contractors

Contractors refers to Medicare Administrative Contractors and other entities that contract with CMS to review and adjudicate claims for Medicare payment of items and services.

Source

42 CFR § 405.201


Scoping language

Scope. This subpart establishes that -
(1) CMS uses the FDA categorization of a device as a factor in making Medicare coverage decisions; and
(2) CMS may consider for Medicare coverage certain devices with an FDA-approved investigational device exemption (IDE) that have been categorized as Category B (Nonexperimental/investigational) device.
(3) CMS identifies criteria for coverage of items and services furnished in IDE studies.

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