Trials supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, CMS, DOD, and VA.
Trials conducted under an investigational new drug application (IND) reviewed by the FDA.
Drug trials that are exempt from having an IND under 21 CFR 312.2(b) (1) will be deemed automatically qualified until the qualifying criteria are developed and the certification process is in place. At that time, the principal investigators of these trials must certify that the trials meet the qualifying criteria in order to maintain Medicare coverage of routine costs. This certification process will only affect the future status of the trial and will not be used to retroactively change the earlier deemed status.