Research Auditing
The OCS performs audits affecting researchers in two areas, HIPAA and Clinical Trails Billing. The IUPUI Research Compliance Office works in conjunction with the OCS is involved with these audits.
HIPAA & Research
The Research Audit involving HIPAA may occur simultaneously with a regularly scheduled, a “for-cause” and/or a special audit as determined by the IUPUI Research Compliance Office and/or the OCS. The major focus of these audits will be based on HIPAA and the Standard Operating Procedures as developed by the IUPUI Research Compliance Office.
Clinical Trials Billing
In June of 2000, President Clinton issued an executive memorandum that directed the Centers for Medicare & Medicaid Services (CMS) to begin paying for certain costs incurred by beneficiaries enrolled in clinical trials. Medicare covers the routine costs of qualifying clinical trials as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials. Medicare has particular billing and documentation requirements for these services to be payable under its program. The audit for Clinical Trials will focus on compliance with Medicare’s billing requirements.
