CMS Tightens Its Purse Strings for Phase I, II Clinical Trials

Sites that want Medicare to reimburse the cost of products used in Phase I or II clinical trials must make sure the device studies clearly indicate therapeutic intent. The Centers for Medicare & Medicaid Services (CMS) has been indicating it won’t cover the cost of drugs or devices that patients receive in such trials because it does not see the studies as therapeutic in intent, according to Mark Barnes of the Huron Consulting Group, who added that no official rule exists to that effect.
Clinical Trials Advisor