Medicare Claims Processing Manual (Pub. 100-04), Ch. 32 § 68
Investigational Device Exemption (IDE) Studies
68 – Investigational Device Exemption (IDE) Studies
(Rev. 3105, Issued: 11-06-14, Effective: 01-01-15, Implementation: 01-05-15)
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.