CMS – Coverage of Clinical Research Services

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.

See National Coverage Determination (NCD) for Routine Costs in Clinical Trials (310.1)

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.