a. Completed UAB Expedited Checklist
b. Study protocol, or UAB IRB Human Subjects Protocol (HSP) if a protocol is not available
c. Draft consent form(s)
d. Departmental bill-to-designation (see marked protocol schema example or excel format) including specific location of service for device implantation. Indicate if inpatient or bedded outpatient admission. Include provisions for device and cost to hospital if applicable.
e. A copy of the department of Health and Human Services (FDA) memo indicating reimbursement category (A or B).
f. Reimbursement manual (if available)
g. Draft clincial trial agreement
h. If applicable, the following completed forms must also be submitted:
i. Radiology Research Quote Request form, and/or
i. If applicable and when available, submit the following:
i. sponsor draft budget or relevant grant/contract budget information, and/or
ii. copy of the Clinical Research Unit (CRU) award letter
NOTE: If research activities are to be provided by an Ancillary Research Area that bills for their services internally department to department (and therefore no billing through a UAB Health System entity), submission to the Ancillary Research Area concurrent with FAP submission is encouraged. For example, if planning to use Tissue Procurement, Dermatology research, or Ophthalmology research services, departments must submit separately to those areas in order to obtain fees for their services.
3. After the CBR reviews the submission for completeness, an acknowledgement email will be forwarded to:
a. department contact noted on UAB Expedited Checklist, and
b. others as needed.
c. Should submission be deemed incomplete, the department submitter will be sent an email relaying what is outstanding for the submission.
NOTE: FAP review cannot begin until all necessary study documents are received, making the department submission complete.
4. Device Trial (IDE) – Phase I
a. FAP Analyst conducts a targeted coverage analysis review, which includes:
i. Review the study protocol and identify protocol-driven clinical billable activities, and the providers and locations for these activities.
ii. Determine whether the clinical trial should be identified as a Medicare “qualifying” trial, with subsequent entry of study type into SiteMinder.
iii. When applicable, review the standard of care (SOC) versus research activities as determined by PI/department on its bill-to designation to facilitate identification of any potential Medicare coverage issues.
iv. Review the cost section of the patient informed consent form
b. Results of the targeted coverage analysis review are emailed to the UAB IRB, with copy to the department contact and others as needed.
i. No response is required of the department unless there are questions regarding review results.
c. SiteMinder Specialist initiates build of study record, site placement record, and budget/visit records in SiteMinder.
5. Device Trial (IDE) – Phase II
a. FAP Analyst submits an email request for research fees of protocol-driven clinical billable activities to the appropriate UAB Health System entity (Hospital and/or HSF/MSO).
b. FAP Analyst performs an initial cursory review of submitted material for inclusion of Radiology and/or flow cytometry clinical activities.
i. If yes for flow cytometry activities, the UAB Hospital Flow Cytometry Lab form and study protocol are forwarded by email to the flow cytometry area for feasibility review and determination of test orderables. Test orderables are converted to a charge description master including price and CPT codes.
ii. If yes for Radiology activities, the Radiology Research Quote Request form along with appropriate study material [study protocol, radiology study manual, etc.] are forwarded by email to the HSF/MSO and Hospital as appropriate.
c. FAP Analyst may direct queries to the department submitter for resolution as part of this review process. It is important that the department works with the FAP Analyst to resolve queries before SiteMinder entry is initiated.
d. FAP Analyst enters protocol-driven clinical billable activities along with associated codes/research fees into SiteMinder budget build developed by the SiteMinder Specialist.
e. FAP Analyst emails research fees for protocol-driven clinical billable activities to the department submitter via a report generated from SiteMinder. The email includes notification that the SiteMinder budget build is ready for department review and data entry.
f. FAP Analyst updates SiteMinder study status to “Under Negotiation”, indicating responsibility for next action resides with the department.
g. Department reviews SiteMinder budget build (including visit names), protocol-driven clinical billable activity list, and enters departmental data (1’s where appropriate) into SiteMinder budget spreadsheet (on charge tab).
h. Department performs a check of all activities and data entry by generating a UABHS report entitled “Research Visit Outline” selected from the SiteMinder desktop.
i. Department is responsible for notifying the SiteMinder Specialist via email that the SiteMinder study budget is acceptable and ready to be finalized.
j. Should the department identify a need for revision, they should email the request to the SiteMinder Specialist assigned to the project.
k. At periodic intervals, CBR staff will email queries to the department to determine the status of SiteMinder studies not yet finalized.
l. The SiteMinder Specialist conducts a review of the proposed final SiteMinder budget and finalizes in the system.
m. The SiteMinder Specialist then emails notification to the department designee that the SiteMinder budget is finalized and ready for use in managing the study and generating electronic clinical trial billing notices (CTBNs).