Additional Justification for Clinical Study Registration

  • The ICMJE member journals require registration of clinical trials as a condition of consideration for publication in their journals
  • It is a Medicare requirement for all clinical trials to register. Clinical trials are defined as:
    • Trials funded by NIH, CDC, AHRQ, CMS, DOD, and VA
    • 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
  • The clinical trial identifier number is required for all items and services provided in relation to participation in a clinical trial, clinical study, or registry that may result from coverage with evidence development, the medical Clinical Trial Policy or CMS approved IDE (investigational device exemption).
  • Effective January 1, 2014 - It will be mandatory to report a clinical trial number on claims for items and services provided in clinical trials that are qualified for coverage as specified in the “Medicare National Coverage Determination (NCD) Manual,” Section 310.0
  • Effective January 1, 2015 - If the clinical trial number is not on the medical claim, it is possible that Medicare could deny the entire claim.