NCD and LCD interpretation is one of the trickiest parts of completing a coverage analysis. When developing the coverage analysis, items/services with applicable NCDs/LCDs can be limited in coverage based your sites interpretations policy. For industry funded studies, these limited items/services can be negotiated into the study budget during the negotiation process with the sponsor/CRO. In contract, for cooperative or federal funded studies, the cost of the limited items/services may fall onto the research department and/or patient. Therefore, sites may decide to have a more risk orientated interpretation policy for cooperative or federally funded studies, which will affect billing designations when developing the coverage analysis.