US · guidance
CMS Pub. 100-04, ch. 32, § 69.1
General
The CMS has issued a National Coverage Determination (NCD) which allows Medicare coverage for
the routine costs of qualifying clinical trial services as well as reasonable, necessary items and services
used to diagnose and treat complications arising from participation in all clinical trials. The coverage
requirements for routine costs of qualifying clinical trial services are contained in the National Coverage
Determinations Manual, Section 310.1, www.cms.gov/regulations-and-
guidance/guidance/manuals/downloads/ncd103c1_part4.pdf
History
(Rev. 13551; Issued: 12-19-25; Effective: 01-21-26; Implementation: 01-21-26)
Provenance
- Source
- cms.gov
- Retrieved
- 2026-08-25
- Edition
- iom-2026-08-25
- Content hash
3da0a2e95d1e8324c400e5a9c6463eeccd59d09d2f0c220b30b4f71d8494deec
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