Additional Justification for Clinical Study Registration
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.
