New Calendar Intake Form/Request for Exemption

• Link to form is located on OnCore home page

• Creates an entry on a Smart Sheet that functions as a “To Do” list for the Oncore Support Team (OST) and Clinical Research Billing Support (CRBS) teams

• Triggers the process of Medicare Coverage Analysis

If this isn’t requested in a timely manner, it will delay the creation and Release of the Calendar. If subjects are consented prior to the Calendar Release, WU and BJC billing staff do not have any guidance on who/how to bill the charges in the billing staffs’ work queue.

Complete Minimum Footprint in OnCore

• Examples of fields within the minimum footprint are Study Phase, Staff roles, and Management groups.

These critical data points are fields that:

• are universally applicable

• meet a number of needs (reporting, integration, etc.)

• must have data quality

• require timely entry

• represent our research portfolio

Coverage Analysts rely on several of the fields included in the Minimum Footprint to complete their MCA (For example: Sponsor for funding information, Staff list for communication with study team during the MCA)

Document Initial IRB reviews (internal/external)

• WU IRB (internal) reviews come over automatically from myIRB

• External reviews need to be entered manually

• OnCore Protocol Statuses must occur in a specific order. The Initial IRB approval status that populates when this information is entered into OnCore comes before the Open to Accrual status. A clinical coordinator cannot enroll a subject in OnCore if this Regulatory task has not been completed.

• Consent forms documented in the Initial Review will be available to the clinical coordinators documenting consent with patients in the Subject Console

For external reviews, this is the only means for the Coverage Analyst (CA) to access and review the approved version of the protocol and consent in order to conduct a MCA and to create a Billing Grid in OnCore for use by WU and BJC billing staff.

Document modifications/Continuing Reviews (internal/external)

• WU IRB (internal) reviews come over automatically from myIRB

• External reviews need to be entered manually
  *Modifications should be entered within 7 days of approval (or receipt by WU study team of all approved documents) in the case of External IRB reviews

• If a new / modified consent form was approved, recording/uploading it in the new review row will make it available to the clinical coordinators who are documenting consent with patients in the Subject Console

• If a new protocol version was approved, uploading in the new review row, and clicking the Release button will make the document available in the PC Console> Documents/Info/Attachments/Links page

• For external reviews, this is the only source of newly approved protocols and consents to allow the CA to access and review updated documents to determine if changes to the Billing Grid are required.

• The updates should be done in a timely manner since active and newly enrolled subjects will be following the newly approved protocol once it is approved. If not done timely, charges will be compared by WU and BJC billing staff to an outdated billing grid.

External IRB Review Notification to CRBS form
*Should be completed at the time of external IRB record completion and upload of all required documents

• Link to form is located on OnCore home page. This form creates an entry on a Smart Sheet so that the CCS Admin team can review and determine if all required documents are uploaded properly and then notifying the CA of the need to review new documents and assess whether updates are required in the Billing Grid.

• There is no existing functionality in OnCore to create this type of Notification. This triggers a review of the modification approval by a coverage analyst.

Update protocol status

• Allows study team and other staff working with subjects on this protocol in order to identify where in the study lifecycle the protocol is

• Allows subjects to be enrolled when Open to Accrual.

• Used in reporting by various University teams for grant writing, etc.

• If subjects are consented and not enrolled in OnCore, the WU and BJC billing staff are not aware to hold the charges for review against the research grid

• Prevents the Coverage Analyst and study teams from wasting time making changes to a billing grid for protocol amendments when our site will not be affected by the protocol changes. For example, if a study is closed to enrollment and all subjects are off study at WU, updates do not need to be made to the billing grid.

Update Staff list

• Allows notifications to function correctly

• Allows access to the OnCore record for study team

• Accuracy of reporting

• Budget signoff must be completed on a calendar

• Provides coverage analyst and BJC billing/compliance teams the correct contact for various questions or concerns that can arise over the life of the study in an efficient manner

Enroll the subject in OnCore / Document consent within one business day of consent.

• Consented subjects are pushed to Epic (where charge entry and billing occur) in real time. The push creates the association between the subject and the study, which is a requirement not solely for billing compliance, but for safety and privacy compliance as well.

• If subjects are consented and not enrolled, the WU and BJC billing staff are not aware to hold the charges for review against the research grid. Charges will be billed to insurance incorrectly (rather than the study account) or to insurance without the correct information attached to the claim.

Log visits on the Subject calendar within two business days of occurrence.

• To provide billing staff with information needed for charge review.

• WU and BJC billers are reliant on the information logged in subject calendars for charge review and assignment to the correct payor.

• Absent or incorrect information increases risk of billing errors.

• Assists anyone reviewing charges or investigating/correcting billing errors.

Update subject statuses

• This will allow visits on the calendar to populate correctly per the OnCore calendar functionality and build.

• Will communicate to other teams working with the patient, where the patient is in the cycle of the study.

• Creates / Ends Epic association between the subject and the study.

• Prevents the Coverage Analyst and study teams from wasting time making changes to a billing grid for protocol amendments when our site will not be affected by the protocol changes. For example, if a study is closed to enrollment and all subjects are off study at WU, updates do not need to be made to the billing grid.

Switching active subjects to newer calendar versions

• Protocol amendments are reflected in a new calendar / billing grid Version.

• Allows for appropriate visit check in with most up to date visits/procedures.

• Incorrect or outdated Subject calendar versions will not contain the most recent visits/procedures for billing staff to refer to when reviewing a charge. Charges may be billed to the wrong payer (insurance vs. study) or to insurance without the correct information attached to the claim.

Address TBD Procedures when checking in visits

• The payer for the procedure (insurance vs. study) is dependent on certain allowable circumstances dictated by financial agreement. Study coordinators are tasked with checking the SOC box next to the procedure on the Subject calendar when a TBD footnote instruction is attached to a procedure and the procedure is SOC.

• A TBD footnote can also be used to explain or differentiate other scenarios. For example, “the physical exam performed by Dept X is SOC, physical exam performed by Dept Y is R.” -Physical exams share CPT codes and the OnCore use by WU and BJC does not allow for duplicated CPT lines)

• Billers will rely on this information when services are designated in the billing grid as R(TBD). They are instructed to bill the service to the study unless the SOC box is checked by the coordinator.

Documenting Additional Procedures within a Visit on the Subject Calendar

• Coordinator clicks the Additional Procedures button to add procedures completed at a visit where they are not required by protocol but should be billed to the study

• Financial agreements sometimes indicate that procedures can be invoiced under certain circumstances when performed at a visit where the procedure is not required by the protocol. These are generally represented in a PRN visit. Billing staff are instructed to look for the CPT code they are reviewing. If found in PRN visit, they are instructed to look for the procedure in the Visit with the Occurred date, on or around the date of the charge that they are reviewing. This is to verify the service is related to the study so the biller can direct the charge according to the OnCore billing grid.

• Additionally, non-compliance with this requirement does cause some departments / BJC to also email the study team before billing the study.

• Additional Procedures should be recorded to provide billing staff information about unexpected procedures (not required at a specific visit by protocol and thus not built into the Billing Grid). For example, if a chest x-ray is not required at Visit 2 but is billable to the study “if done” per the study agreement, the biller will see this added under Visit 2 and refer to the PRN visit (set up by CA’s to reflect contract or consent language as appropriate) for billing designation.

Documenting Additional Visits in the Subject Console under the Calendar menu item (unscheduled/not represented in OnCore calendar)

• Coordinator clicks the Additional Visits menu item to add Visits that are performed in relation to the study and not already represented in the OnCore calendar.

• Financial agreements sometimes indicate that procedures can be invoiced under certain circumstances when performed at a visit where they are not required by the protocol. These are generally represented in a PRN visit. Billing staff are instructed to look for the CPT code they are reviewing. If found in PRN visit, they are instructed to look for an Additional Visit on or around the date of the charge they are reviewing, on the Additional Visits menu item. This is to verify the service is related to the study so the biller can direct the charge according to the OnCore billing grid.

• Additionally, non-compliance with this requirement does cause some departments/BJC to also email the study team before billing the study.