Medicare Coverage Analysis 

Medicare Coverage Analysis (MCA) is required for all clinical research studies in which tests, procedures and interventions associated with the research can potentially be billed to third party payers or subjects. The MCA must be performed prior to enrolling subjects and initiation of clinical research procedures to assure proper billing of services.

Medicare covers the routine costs of qualifying clinical trials (per National Coverage Determination for Routine Costs in Clinical Trials, 310.1) and reasonable and necessary items and services used to diagnose and treat complications arising from participation in clinical research.

The Clinical Trials Innovation Unit’s Research Finance Team will perform Medicare coverage analyses on studies seeking Medicare. Initially the analysis will be based on the study’s protocol, consent, sponsor exhibit and Clinical Trial Agreement, but notes will also be provided regarding any item or service subject to a proposed sponsor payment that may be billable to Medicare or other payers as conventional care. The research team will be provided with a Medicare Coverage Analysis Report (MCAR) and will have this information available for their negotiations with the sponsor.

The Research Finance Team provides the following services to help investigators with the Medicare Coverage Analysis:

  • Review study to determine if a submission to Novitas-Solutions or CMS is needed
  • Review budget to insure CPT codes are correct and billable together or separately
  • Review language in the ICFs, Budget Exhibit, and/or Contract to ensure Medicare or financial compliance, making suggested changes as appropriate
  • Assist with gathering needed documents for submitting to Novitas-Solutions or CMS
  • Ensures that Hospital Compliance is notified and receives required documents for submission to Novitas-Solutions or CMS

Program Leadership

Mtonya Hunter-Lewis
Regulatory Management Supervisor