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New protocols:

The coverage analysis process is triggered in the CRMS record. When you create a study record in CRMS, there is a Study Status field with a drop down menu, available in both the Dashboard and Submissions sections of the record:

Screen Capture: The “Study Status” dropdown menu is circled.

LEAVE THIS FIELD BLANK until you have a protocol.

When you have a protocol, enter a study status of New:

Screen Capture: The “Study Status” dropdown menu has been set to “New.”

This will trigger the OCT coverage analysis review:

  • An OCT BCA Team member will contact you and obtain preliminary information needed for the review.
  • The BCA analyst will then review your study for billing status and build a schedule of events billing grid using the BCA Excel workbook in CRMS. This will be based on CMS, local, and institutional regulations.
  • If there will be no study-related billing through Epic, the analyst will document this in CRMS and let the hospital Research Billing Review (RBR) team know so that claims related to subjects on the study will not be held for charge review.
    • This “No Billing” status pertains only to prospective costs. If a subject has a study-related adverse event which requires treatment with services billed through Epic, be sure to link the encounter to the study, and notate in the medical record so that the RBR group will know to review the charges and add the appropriate modifiers to the claims.
  • After the billing grid is complete, the BCA analyst will meet with the PI and any study team members that would like to participate. This meeting can be conducted via phone or through Microsoft Teams or Zoom. Any revisions needed will be made, and the BCA workbook will be advanced for PI approval in CRMS.
  • Once approved, the BCA analyst will build the Epic calendar for non-Oncology protocols, or send to Lineberger for Oncology protocols.
  • When all compliance checks are completed by all applicable departments, the BCA analyst will activate the protocol in Epic.

Existing Protocols with Amendments

If you have a protocol amendment that requires new services or adds new study visits with Epic billable services, and already have a BCA completed and/or a billing calendar in Epic, you should contact your assigned BCA analyst to help with the revision. If the original BCA was completed before the centralized BCA process, you can email to request a coverage analysis.

OnCore Enterprise Impacts on the Coverage Analysis Process

  • When your department or clinical area moves to OnCore Enterprise, the coverage analysis process will remain essentially the same, but instead of being triggered in CRMS by the study status, it will be triggered in OnCore when a new or amended protocol calendar is validated.
  • The billing grid will be created and maintained in the Financials console.