42 CFR § 405.211 - Coverage of items and services in FDA-approved IDE studies.
---
identifier: "/us/cfr/t42/s405.211"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "42 CFR § 405.211 - Coverage of items and services in FDA-approved IDE studies."
title_number: 42
title_name: "Public Health"
section_number: "405.211"
section_name: "Coverage of items and services in FDA-approved IDE studies."
chapter_name: "CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "B"
subchapter_name: "MEDICARE PROGRAM"
part_number: "405"
part_name: "FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED"
positive_law: false
currency: "2026-03-24"
last_updated: "2026-03-24"
format_version: "1.1.0"
generator: "[email protected]"
authority: "42 U.S.C. 263a, 405(a), 1302, 1320b-12, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk, 1395rr, and 1395ww(k)."
cfr_part: "405"
---
# 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 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*.
[78 FR 74809, Dec. 10, 2013]