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 participants. The MCA must be performed prior to enrolling participants 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 that could possibly seek Medicare payments. 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 investigator will be provided with a Medicare Coverage Analysis Report (MCAR) and will have this information available for negotiations with the sponsor.
The Research Finance Team provides the following services to help investigators with the Medicare Coverage Analysis:
- Determine and designate the appropriate payer for expected billable research-related service and procedure charges
- Review study to determine if a submission to Novitas-Solutions or CMS is needed
- 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
- Review budget to insure CPT codes are correct and billable together or separately
- Review language in Informed Consent Forms, Budget Exhibit, and/or Contract to ensure Medicare or financial compliance, making suggested changes as appropriate
Please submit requests for Financial Management services through the TRI Services Portal. Select Budget Development and Budget Negotiation when completing the request form.