Welcome to the Clinical Research Calendar Review & Analysis Office (CRAO)
The Clinical Research Calendar Review & Analysis Office (CRAO), which is a part of the Medical School Office of Research and was formerly known as the Clinical Research Billing Unit (CRBU), was created to ensure items/services that research teams intend to bill to Medicare and other third party payers are consistent with federal regulations.
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The mission of the Calendar Review & Analysis Office (CRAO) is to complete a Medicare Coverage Analysis (MCA) and billing calendar review for all Human Subject Clinical Trials that have billable items and services to ensure consistency with all five core documents, and to allow for the appropriate adjudication of charges
The CRAO’s vision is to support and collaborate with researchers and study teams to produce a uniform process for the Clinical Research Billing Calendar, Budget and Enrollment. We provide stellar customer service and foster partnerships with various other research support areas internal and external to UMHS.
To ensure the Clinical Research Billing process is universally utilized throughout the research continuum at UMHS and is compliant with Meidcare guidelines and rules.
In 2007, the Health System created a Clinical Research Billing Unit (CRBU) — now called the Clinical Research Calendar Review & Analysis Office (CRAO) — which is a part of the Medical School Office of Research. This unit was created to ensure items/services that research teams intend to bill to Medicare and other third party payers are consistent with federal regulations. The CRAO process is a QA process to ensure that all of your study documents (protocol, consent, budgets, contracts/grants, billing calendar, etc.) align with each other and do not conflict with any federal or institutional policies related to research billing. All clinical research that involves billable items and services initiated after November 1, 2006 are required to create a billing calendar and submit it to the CRAO along with the study documents. For information on how to create a billing calendar, please see the "Billing Calendar Instructions" and "Billing Calendar Template" in the "Resources for Review" section. If you are unsure if you need to create a billing calendar for your study, review the "CRB Initial Review Form" in the "Resources for Review" section. Although the CRAO is proactively contacting research teams who have submitted information on eResearch, all research teams are encouraged to contact the CRAO directly when new clinical research is being initiated.
Clinical Research Billing & Medicare
The Centers for Medicare and Medicaid Services (CMS) have established policies and guidelines regarding billing for routine care provided to patients participating in clinical trials. Faculty and staff conducting clinical research need to know that:
- Medicare will pay for 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.
- Items and services provided solely to support the research goals of the trial must not be billed to Medicare.
- Failure to bill Medicare appropriately may result in fraud investigations.
