US · guidance
CMS Pub. 100-04, ch. 32, § 68
Investigational Device Exemption (IDE) Studies
See Pub. 100-02, Medicare Benefit Policy Manual, Chapter 14 for complete Medicare coverage requirements for
items and services in Category A and B IDE studies, related to these billing requirements.
NOTE: For information regarding Medicare coverage related to IDEs in Medicare Advantage plans, refer to Pub.
100-16, Medicare Managed Care Manual, chapter 4, section 10.7.2.
History
(Rev. 3105, Issued: 11-06-14, Effective: 01-01-15, Implementation: 01-05-15)
Provenance
- Source
- cms.gov
- Retrieved
- 2026-08-25
- Edition
- iom-2026-08-25
- Content hash
7bafd932bae231a921815ce5748ba8dfff5bfa02c96e7bc9b002e481a9747b43
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