The signed Clinical Trial Agreement (CTA) or Contract dictates when and how UCSF may bill a sponsor. It is the source document for billing and takes precedence over any other communication or record. If an expense was not accounted for in the signed agreement, an amendment to the contract would need to be requested, negotiated and signed. Contact your RSC or ICD officer to begin the process.
Expenses related to your clinical trial budget must be treated consistently across all study documents and sources of payment (i.e. payors). For example, if the sponsor agrees to cover the cost of Procedure A, then the Informed Consent must reflect this; it should not indicate that the patient or their insurance carrier will be responsible for the cost.
Since all medical procedures must be billed consistently to all payors, if the contract states that the sponsor will pay for Procedure A, then the sponsor must be billed for every occurrence of Procedure A across all accrued subjects, i.e. you cannot bill Medicare for Procedure A performed on Subject XYZ and bill the sponsor for Procedure A performed on Subject LMN. A potential exception to consistency in billing payors would be if a subject is eligible for a reduction in charges under UCSF’s charity care assistance policy. Under these circumstances, it could be possible to bill the sponsor for a procedure that otherwise would be charged to the patient, or insurance carrier for all other subjects. However, the contract should have specific provisions and procedures for these situations prior to the patient joining the study. If these provisions do not exist in the original agreement, an amendment to the contract is necessary. These exceptions are on a case-by-case basis and justifications should be fully documented. For more information about using APeX in applying your coverage analysis to specific procedures and services at UCSF please go here. |
Expenses related to your clinical trial must be treated consistently across:
All expenses related to the conception, execution, and close-out of a clinical trial need to be captured and accounted for in the budget and billing processes. Expenses include but are not limited to:
|
|
|
|
|
A Coverage Analysis (CA) is a tool that applies billing rules to the protocol’s schedule of events and facilitates an accurate and thorough budget. A CA is necessary for all clinical projects that have patient encounters.. The CA can:
|
Locating the UCSF Charge Master Log in to MyAccess* –> Click on “CHR –> iRIS” –>Click on the Help link in the upper right-hand corner –> Click on the Charge Master link in the “Clinical Research Services” section. * If off-campus, first go to https://vpn.ucsf.edu, then click on MyAccess |
Need assistance or have clinical trial budget/billing questions?
Please contact [email protected]