Office of Coverage Analysis Administration (OCAA)

A coverage analysis (CA) identifies the financial accountability for each item or service in a clinical trial.  It is an in-depth review of clinical trial documents, National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and published practice guidelines to determine the Medicare billing status of items and services that are documented in the research protocol.  As a result, services will be appropriately billed to a third-party payor (e.g., Medicare, private insurance, or the patient), the trial sponsor, the study grant or other funding source. 

All studies involving human research subjects require a review for coverage analysis. A CA is required to use Medical Center resources and facilities. There are some scenarios where a CA is not required, such as studies only reviewing medical records.

BENEFITS OF THE COVERAGE ANALYSIS

A coverage analysis ensures clinical research billing is compliant by Medicare standards, provides transparent clinical research transactions to prevent billing errors, and may be used as a tool to estimate costs and negotiate study budgets.

HOW IS A COVERAGE ANALYSIS INITIATED AND WHO COMPLETES THE REVIEW?

A project submission to the Human Research Protection Program (HRPP) triggers an automated notification to OCAA for coverage analysis review.  OCAA comprises a team of analysts who specialize in Medicare policies and healthcare guidelines. The analysts work closely with the Principal Investigators (PI's) and their study teams to review and finalize the coverage analysis.  

BUDGETING SERVICES 

OCAA now offers budgeting services for industry initiated clinical trials.  With the increasing costs and demand of clinical trials, our team offers full concierge services to execute your study budgets and to enhance your experience with the study sponsor.  We will develop a detailed budget and negotiate the figures with the sponsor to ensure the sponsor covers the full cost of conducting the study at UCSD.

WHAT YOU CAN EXPECT FROM OUR BUDGETING SERVICE

Customer Service: We keep the PI apprised of the budget at all stages of the process.  We offer in-person meetings to review our budgets to ensure the PI’s input and budget goals are incorporated in our budgets.  Each budget will be assigned an experienced analyst that will be your main point of contact should you need any clarification.  Our analysts will be available via phone, email or in-person meetings to ensure the budget meets your needs.

Comprehensive Reviews: We capture all of the costs of conducting the clinical trial.  In our budget development process we identify and budget for all costs from the beginning with study start-up costs all the way through to study close out costs, direct and indirect costs, per patient costs, personnel costs, invoice costs, supplies/equipment and facility costs, and central office fees.

Competitive Timelines: Our review and first draft of the budget will be sent out to the sponsor within 4 - 6 weeks of receiving the budget request. 

Quality: After the study has started, we will follow up with your team for feedback.  In the event the budget provided to you does not capture the appropriate costs we will renegotiate the budget with the sponsor.  

HOW TO REQUEST OUR BUDGETING SERVICE

*Submissions for NEW budgets may also be requested through Kuali Research at the time of your Kuali Proposal submission.