A Medicare Coverage Analysis (MCA) is necessary for all clinical trials involving interventions in which any items and services are or may be invoiced to the patient insurer(s). The MCA involves determining the underlying eligibility of the study for Medicare coverage and reviewing the clinical events specified in the Protocol (and outlined in the Protocol Billing Grid) to determine which items or services may be billed to Medicare. Medicare’s Clinical Trial Policy only allows coverage of routine costs during qualifying clinical trials.
Medicare will not cover costs that are
- paid for by the sponsor,
- promised free in the informed consent document,
- not ordinarily covered by Medicare, or
- solely to determine trial eligibility or for data collection or analysis.
Lastly, if this study involves a IDE device, Medicare’s IDE # Policy requires that the local Medicare Contractor determine the coverage of services/items acceptable to invoice to Medicare and a copy of this determination letter should be obtained prior to the release of claims.