GroundRules
42 CFR 405.211: Coverage of items and services in FDA-approved IDE studies.
Where this section sits in the code
- Title 42—Public Health
- CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER B—MEDICARE PROGRAM
- PART 405—FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED
- Subpart B—Medical Services Coverage Decisions That Relate to Health Care Technology
(a) Coverage of routine care items and services for Category A (Experimental) devices. Medicare covers routine care items and services furnished in an FDA-approved Category A (Experimental) IDE study if CMS (or its designated entity) determines that the Medicare coverage IDE study criteria in § 405.212 are met.
(b) Coverage of Category B (Nonexperimental/investigational) IDE devices and routine care items and services. Medicare may make payment for a Category B (Nonexperimental/investigational) IDE device and routine care items and services furnished in an FDA-approved Category B (Nonexperimental/investigational) IDE study if CMS (or its designated entity) determines prior to the submission of the first related claim that the Medicare coverage IDE study criteria in § 405.212 are met.
(c) CMS (or its designated entity) must review the following to determine if the Medicare coverage IDE study criteria in § 405.212 are met for purposes of coverage of items and services described in paragraphs (a) and (b) of this section:
(1) FDA approval letter of the IDE.
(2) IDE study protocol.
(3) IRB approval letter.
(4) NCT number.
(5) Supporting materials, as needed.
(d) Notification. A listing of all CMS-approved Category A (Experimental) IDE studies and Category B (Nonexperimental/investigational) IDE studies shall be posted on the CMS Web site and published in the Federal Register.
Collected 2026-08-27T02:26:11Z. Source file · JSON