---
kind: "section"
citation: "42 C.F.R. § 405.211"
title: "42"
number: "405.211"
heading: "Coverage of items and services in FDA-approved IDE studies."
url: "https://uscodex.org/cfr/42/405.211"
---

# §405.211. Coverage of items and services in FDA-approved IDE studies.

- (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](/cfr/42/405.212.md) 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](/cfr/42/405.212.md) are met.
- (c) CMS (or its designated entity) must review the following to determine if the Medicare coverage IDE study criteria in [§ 405.212](/cfr/42/405.212.md) are met for purposes of coverage of items and services described in paragraphs [(a)](#a) and [(b)](#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.

## Notes

### 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]