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ORA FAQs
Who is responsible for research billing compliance?

The PI has ultimate responsibility for achieving research billing compliance, but the full support of the study team is needed in order to do so successfully.

 

The PI has primary responsibility to understand and comply with rules for billing Medicare, Medicaid and third party payors for services, drugs, devices, tests and procedures rendered in the clinical research context.   Study site personnel (including patient service representatives, billers, coders, clinic administrators, service providers) are responsible for working with the Principal Investigator and study team to ensure that services for patients enrolled in research studies are scheduled, coded, billed and recorded in accordance with the Separation of Allowable Costs coverage analysis, seeking clarification when questions arise.


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