Do Clinical Research Billing Compliance laws, rules and regulations apply only to Industry sponsored studies?
No. Medicare and Private Payor rules and requirements for documentation, coverage, and billing DO apply to ALL clinical studies. The funding source or lack of an outside funding source (internally funded or unfunded) is not relevant. Therefore, it is important to perform itemized coverage analysis to identify which protocol services are billable and, when encountered using CareConnect, to enter timely, complete and accurate study, enrollment and encounter information.