1. Is pre-authorization required from private insurers for costs associated with a clinical trial?
- Yes. Pre-authorization is required from private insurers for coverage of the standard of care (routine care) costs associated with the clinical trial.
2. Are routine care costs associated with a clinical trial covered by private insurance coverage?
- Yes. The routine patient care costs associated with clinical trials covered by Medicare’s Clinical Trial policy will qualify for private insurance coverage.
3. What does routine patient costs include?
- Routine patient costs include all items and services consistent with the coverage provided in the plan (or coverage) that is typically covered for a qualified individual who is not enrolled in a clinical trial.
4. Who is responsible for performing a Medicare Coverage Analysis (MCA)?
- The Yale Center for Clinical Investigation (YCCI) Medicare Coverage Analysis Unit.
5. What is the purpose for a MCA?
- Performing an MCA ensures the following:
- Develop a budget;
- Assist in budget negotiations;
- Facilitate billing compliance;
- Mitigate risk and avoid billing errors which can result in civil and criminal penalties; and
- Ensure compliance with billing rules.
6. What is the next step once the MCA is completed?
- Once the MCA is completed, a study-specific billing summary listing all items and services is available to the PI and study team. The billing summary must identify what services should be billed to the research study sponsor and what can be billed to Medicare or third-party payers.