Clinical Trial Coverage Analysis
The Aurora Research Institute requires a Clinical Trial Coverage Analysis (CTCA) for all research studies. The CTCA must be performed prior to enrolling study subjects and initiating clinical research procedures. The purpose for the CTCA is to determine what routine costs of a clinical trial can be billed to Medicare/private insurance and what costs a sponsor must provide funding for. This process makes sure there is funding for procedures ensuring Aurora’s revenue is maximized.
In order to bill Medicare/private insurance for routine care costs of items and services, a clinical trial must meet certain criteria to qualify for reimbursement. RBS will determine whether your clinical trial meets the requirements for reimbursement by Medicare for routine costs. The completed CTCA is given to one of RBS Specialists to aid them in preparing and negotiating budgets.
A CTCA helps:
- Investigators determining the financial feasibility of a proposed study.
- Investigator Initiated Researchers develop a study budget.
- Ensure accurate and compliant billing by providing documentation to verify that research driven procedures are billed to the appropriate party
- Protects potential research subjects as it informs them, as it is reflected in the informed consent process, as to their potential financial liability as a result of participating in a study.
Aurora will charge industry sponsors a fee for preparation of the CTCA.
While the CTCA usually only looks at Medicare Billing regulations, all subjects in a study are billed consistently as if they were a Medicare Beneficiary.