Investigational clinical service provided in a clinical research study that is in an approved clinical research study

Correct Use

• When an investigational service is performed as part of an approved clinical research study
  • Investigational clinical services are defined as those items and services that are being investigated as an objective within study
  • Investigational clinical services may include items or services that are approved, unapproved or otherwise covered (or not covered) under Medicare

Incorrect Use

• When service is not part of an approved clinical research study
• When service is not investigative in nature

Resources

• CMS Clinical Trial Policies
• National Coverage Determination for Routine Costs in Clinical Trials (310.1)
• CMS Medicare Learning Network (MLN) Matters (MM)5805
• CMS Change Request (CR) 7012
• CR 8401