Before billing the 'routine costs' associated with a clinical research trial to Medicare or other insurance carriers who follow Medicare's Clinical Trial policy is performed, it should be determined if the trial meets their 'qualifying' criteria and if the services meet the 'routine costs' criteria. Below is some information to assist in determining if the trial 'qualifies' (not applicable to device trials.)
How to Tell if a Clinical Trial is a "Qualifying" Trial
Each of the checklists below can be used to determine if a clinical trial meets Medicare's qualifying criteria. Either form may be used.
- Worksheet Option 1
- Worksheet Option 2
- Worksheet Option 3
- CMS letter to AAMC clarifying qualifying trials 14-May-2014
The worksheet below discusses criteria for Determination of Routine Costs of a Qualifying Clinical Trial (not applicable to device trials).