Medicare Clinical Trial Policy (CTP)
Effective July 9, 2007, NCD 310.1, Routine Costs in Clinical Trials, is
revised to clarify that the item or service under investigation in a clinical trial, if covered outside the trial, is
covered in the context of the trial.
In addition, effective July 9, 2007, NCD 310.l, Routine Costs in Clinical Trials, is revised to add coverage
with evidence development (CED). CED is determined through the NCD process, and conditional upon
meeting standards of patient safety and clinical evidence, items and services not otherwise covered would be
considered "reasonable and necessary" in the context of a clinical trial.
This revision of section 310.1 of Pub. 100-03 is a national coverage determination (NCD). NCDs are
binding on all carriers, fiscal intermediaries, quality improvement organizations, qualified independent
contractors, the Medicare Appeals Council, and administrative law judges (ALJs) (see 42 CFR section
405.1060(a)(4) (20
Issued by: Centers for Medicare & Medicaid Services (CMS)
Issue Date: September 07, 2007
DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.