You have submitted the Study Initiation Form.
Now what happens?
- The Study Record is created. The submission is routed to the Calendar Analysts who use the information in the first section of the form to create a study record in OnCore. This record, also referred to as the “OnCore Shell,” may be used for effort tracking, pipeline review, and other initial study management tasks within OnCore.
- The Study Calendar is created. If coverage analysis is necessary, the Calendar Analysts begin building a study calendar in OnCore.
- The Billing Grid is used to document coverage analysis. Coverage analysis is completed within the Coverage Analysis Console, which may be found in the “Financial” drop down from the menu in OnCore. Inside the Coverage Analysis Console, the Billing Grid is used to provide the documentation of the Coverage Analysis. The Billing Grid includes a version of the study calendar that designates each procedure as being billed to the study “R,” or billed to the subject “S.” Additionally, the Billing Grid includes a comments section, this is where you will find justifications for the procedures designated to be billed to the patient/patient insurance. These justifications come from Medicare National and/or Local Coverage Determinations, National Guidelines (i.e. NCCN, American Heart Association), and Peer Reviewed Journals.
- The Study Documents are aligned. Additionally, and of equal importance to the billing grid, is the piece of Coverage Analysis referred to as a Document Alignment. This procedure consists of reviewing the Protocol, Informed Consent, and funding documents (i.e. Sponsor or department Budget, Clinical Trial Agreement, or Grant Approval Document) to ensure consistency of Subject Injury Language and Subject Stipend/Reimbursement.
The patient injury language needs to align with Medicare “Payer of Last Resort” rules. Specifically, these documents need to state that either the patient or patient’s insurance is responsible for the cost of the procedures if a patient is injured while on the study, or the Study or Study Sponsor is covering all of those costs. An example of unacceptable language is, “Sponsor will pay for any costs not covered by patient insurance, if injured while on this study.” This language indicates that the sponsor will pay copays and deductibles and this cannot be allowed.
- The study information is reviewed. After receiving notice of completion of the coverage analysis, PIs, coordinators, and other members of the research unit are responsible for reviewing the Billing Grid and the communication from the Coverage Analysis team. If there are questions, comments or concerns on the part of the Research Unit, it should be discussed with the Coverage Analysis Team for clarification.