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Clinical trials financial compliance: The Principal Investigators and liability.

6097 Background: Clinical trials compliance has become more scrutinized with the national coverage decision and billable services. Meticulous financial planning is essential to fiscal success. Cost effective achievement through billing and accounts receivable will ensure compliance with federal guidelines. A clinical trials office conducting audits of patients" bills minimizes problems in billing compliance.


METHODS
A large clinical trials office manually reviewed HCFA Uniform Bill-92 for accuracy in charging. A conscientious effort was made to properly identify protocol specific research procedures and tests and budgets were established with accuracy. Standard of care, routine tests were acknowledged and an effort was made to code properly. "Research only" tests and procedures were placed on proper account as a new encounter form was established within the Cancer Clinic. In-services were executed to advise staff of agreed upon budget. Patients' bills were reconciled against schedule of events calendars and study milestones by nurse and administrative assistant. Accuracy in HCFA Uniform Bill charges increased by 50%.


RESULTS
Patients and third party payers were not billed inappropriately for research related activities. Patients bills were hand tracked when they had certain types of third party payers to ensure billing compliance. Sponsored research was appropriately and accurately contracted to cover research related activities. Financial and research compliance have become a priority for the University with new positions created to continue to work on processes for the future.


CONCLUSIONS
Clinical research priorities include billing process improvement, compliance monitoring, and clinical trials management. Training and educational opportunities for precision budgeting are being initiated with the goal of offering a standardized budget formatting tool within the next few months. A review process by a specialized clinical trials budget expert has begun to assess financial feasibility and risk, as well as tracking billing compliance. No significant financial relationships to disclose.