US · guidance
CMS Pub. 100-16, ch. 4, § 10.7.2
Payment for Investigational Device Exemption (IDE) Studies
MAOs are responsible for payment of claims related to enrollees’ participation in both
Category A and B IDE studies that are covered by the MAC with jurisdiction over the
MA plan’s service area. The MAO is responsible for payment of routine care items and
services in CMS-approved Category A and Category B IDE studies. The MAO is also
responsible for CMS-approved Category B devices. CMS will not approve Category A
devices because they are statutorily excluded from coverage.
CMS finalized changes to the IDE regulations (42 CFR § 405 Subpart B), effective
January 1, 2015. A listing of all CMS-approved Category A IDE studies and Category B
IDE studies will be posted on the CMS Coverage webpage site located at:
http://www.cms.hhs.gov/center/coverage.asp and published in the Federal Register.
History
(Rev. 121, Issued: 04-22-16, Effective: 04-22-16, Implementation: 04-22-16)
Provenance
- Source
- cms.gov
- Retrieved
- 2026-08-25
- Edition
- iom-2026-08-25
- Content hash
8bc369bc47c059ef47af43f93c2f3c2ca3afeddadb7086473af6d3c76cb6e868
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