Applies to: All Human Subjects Clinical Research that includes protocol-required services that will be billed to participants/insurance
Effective date: 09/19/2000
The Center for Medicare and Medicaid Services (CMS) coverage includes “routine costs” of “qualifying” clinical research studies. Both “routine costs” and “qualifying” are terms that CMS has defined.
Note: Medicare has confirmed that even though the NCD was originally drafted for “clinical trials”, the rules apply to any human subjects clinical research studies.