General

69.1 – General (Rev. 13551; Issued: 12-19-25; Effective: 01-21-26; Implementation: 01-21-26) 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