Effective 6/1/2013, UCSF requires a comprehensive Coverage Analysis (CA) for all new clinical research in which there are patient care services, as well as protocol amendments altering medical procedures/services. This formal CA must be completed in the OnCore Clinical Trial Management System on every clinical research study that includes a clinical procedure or service performed on human subjects (e.g., blood draw, x-ray, biopsy, etc.) before any subjects are enrolled and before an award is released.
This requirement is applicable to every clinical study/clinical trial regardless of the funding source e.g.: industry, non-industry, and gift funded clinical studies. This is a best practice at leading research institutions because it ensures financial and compliance benefits for subjects, sponsors, and research institutions. We recommend scheduling a CA consultation prior to proposal submission.
The CA is a tool utilized to coordinate the study information of clinical research billing and to document that reasoning for qualifying and non-qualifying clinical trials. The analysis consists of a complete review of the trial protocol, patient informed consent and Clinical Trial Agreement (CTA), funding sheet or budget, or notice of grant award to determine the final billing designation for all procedures identified in the protocol. Final billing designations include services reimbursed by insurance, sponsor or an internal funding source. The CA process ensures harmonization amongst the clinical trial documents.
In addition to improving downstream accuracy of billing for clinical trial services, the CA also improves and streamlines the budget process. This permits UCSF and sponsors to fully identify and document all items and services that are required to fulfill the scope of work (i.e. protocol) and the associated payments. This investment in pre-award work reduces post-award administrative and financial difficulties.
In addition to a CA, the details of a study, including all tests and procedures included in the study that are outlined in the research plan of a proposal (called a protocol) must be approved by an Institutional Review Board (IRB)/Committee on Human Research (CHR).
UCSF currently has three units that are qualified and approved to perform a CA. These are the Office of Clinical Research (OCR), the Cancer Center Investigational Trials Resource (ITR), and the Division of Cardiology. The creation of a CA can run in parallel with many other pre-award activities and does not prevent the submission of a grant application. Since billing regulations may change at any time, the most current coverage review should occur just prior to opening enrollment at UCSF. The formal coverage analysis will be sent to the Principal Investigator upon completion to provide an opportunity for review and requires the PI approval, prior to subject accrual.
For questions regarding the Coverage Analysis process, please contact:
- Office of Clinical Research (OCR): email@example.com
- Cancer Center Investigational Trial Resource (ITR) - Greg Nalbandian, ITR Coverage Analyst: firstname.lastname@example.org
- Division of Cardiology - Carol Maguire, Administrative Director of Clinical Research: email@example.com
- Clinical Enterprise Compliance Program-Office of Ethics and Compliance - Jacquie Eichhorn, Manager, Clinical Research Billing Compliance: firstname.lastname@example.org