Coverage Analysis
Non-Cancer Clinical Trials Process
Welcome to the Coverage Analysis Process page for Clinical Trials.
Click on the plus sign (+) to expand a step. An Overview provides a summary description.
Before submitting study in SeRA, please consider how you will conduct study within Stanford, such as use of CTRU, Investigational Pharmacy, Inpatient Units, equipment provided by Sponsor, and specific CPT codes needed for protocol procedures.
If you have any questions regarding the CA process for non-cancer industry sponsored clinical trials, contact your assigned CT RPM.
Click on the flip cards to learn more about the role you play in the CA process.
Study Team
Study Team:
Collects and uploads all essential documents to CT PDRF, including the Protocol, Draft Informed Consent Form (or Investigator Brochure for drug studies, if draft ICF not available), CTRU Budget Tool, if applicable, and Clinical Trial Agreement.
Reviews protocol procedures and considers study logistics (ie. use of CTRU).
Completes and routes CT PDRF in SeRA.
Responds to CT RPMA if essential documents are missing from CT PDRF.
Huron
Huron Team:
No action required.
CT RMG
CT RPMA:
Reviews CT PDRF for completeness and if necessary, returns CT PDRF to collect missing details.
CT RMG:
Reviews the CA Decision Tree to determine if the study is in scope for Coverage Analysis.
If CA is in Scope:
Collects supporting files and initiates CA request.
If CA is not in Scope:
Email study team to inform them that a CA is not required, and the budgeting will proceed without CA.
Overview: For all clinical research that meets Stanford's Industry Sponsored Clinical Trial (CT) criteria, Study Team completes and routes a CT PDRF in SeRA. CT RPM confirms CA is required. To prevent delays in contract execution, best practice is to submit protocol to IRB when submitting study documents to CT RMG (i.e. follow parallel process).
Study Team
Study Team:
Responds to CT RPM’s request to complete Study Team Operational Plan with specific study details that impact development of CA Billing Grid.
Huron
Huron Team:
Huron is automatically notified of new CA document upload.
Reviews CA submission to Huron Communities Portal and internally assigns.
Reviews comments provided by CT RPM.
CT RMG
CT RPM:
Requests specific study details within the Study Team Operational Plan to initiate the CA process with Huron.
Requests CA within Huron Communities Portal with information provided by study team and to align CA Billing Grid with Sponsor's Payment Schedule.
Overview: CT RMG Intake team reviews CT PDRF details and study documents. If required, additional information to prepare CA Billing Grid is requested from the study team by CT RPM. CT RPM initiates a CA transaction within Huron Communities Portal with notes to align CA Billing Grid (BG) with Sponsor’s Payment Schedule. Huron reviews study documents submitted to Huron Communities Portal and begins CA (timeline to complete 10 business days).
Study Team
Study Team:
Provides feedback to CT RPM either by email or in person during Coverage Analysis Review (CAR) Meeting. The study team:
- Confirms Billing Designations
- Validates hospital service billing codes and number of occurrences
- Replies to questions posed by Huron
Huron
Huron Team:
Prepares Draft CA Billing Grid (BG) that lists hospital services with identifiable codes.
Color codes all procedures with billing designations at each protocol defined timepoint.
Uploads Draft CA to Huron Communities Portal.
Updates BG based on feedback.
CT RMG
CT RPM:
Retrieves the Draft CA from Huron Communities Portal.
Facilitates the study team’s timely review of CA Billing Grid (BG) and if needed, schedules a Coverage Analysis Review (CAR) meeting.
Reviews email with requested changes or documents Study Team feedback during CAR meeting in the “Comments” column of the BG.
Reviews BG in comparison to Sponsor's Payment Schedule:
- number of occurrences
- invoiced procedures
Escalates concerns to sponsors and updates PI as appropriate.
Overview: Huron prepares the Draft CA Billing Grid (BG) that lists hospital services with identifiable billing codes and uses color coded billing designations for each service at each timepoint required per protocol. CT RPM facilitates Study Team's review of BG and compares BG to the Payment Schedule. Study Team reviews and provides feedback to CT RPM prior to KO meeting.
Study Team
Study Team:
Reviews and approves the Draft CA by placing initials/date in yellow boxes at top of the “Investigator Review” tab so that Initial Approved CA can be released.
Please note the Investigator Review tab is a summary of the Billing Grid tab and review of both tabs is not required.
Huron
Huron Team:
If necessary, revises the Draft CA Billing Grid based on notes and feedback from PI/study team.
CT RMG
CT RPM:
Facilitates study team/PI review and approval of the Draft CA via the “Investigator Review” tab.
Notifies Huron that the study team/PI has approved the Draft CA.
Uploads Initial Approved CA into Huron Communities Portal.
Uses Initial Approved CA to prepare draft budget.
Overview: CT RPM partners with Study Team to confirm details in BG and when necessary, requests updates to CA by Huron prior to approval. CT RPM uploads Initial Approved CA to Huron Communities Portal with documentation of PI’s approval of Billing Grid within the “Investigator Review” tab. The CT RPM uses the Initial Approved CA to prepare draft budget.
Study Team
Study Team:
No action required.
Huron
Huron Team:
When requested, attends KO meeting.
If required and compliant based on new information, updates BG to align billing designations/CA with study budget.
CT RMG
CT RPM:
Prepares draft Internal Budget based on Initial Approved CA.
Prepares budgeting questions re. BG to address during KO meeting.
Uses Budget Grid to align cost estimate within Sponsor’s Payment Schedule.
Finalizes Internal Budget and Payment Schedule.
Negotiates budget with Sponsor.
If needed, discusses relevant budget-related changes to the BG with Huron.
Overview: Based on Initial Approved CA, CT RPM develops draft Internal Budget in preparation for discussion at KO meeting. If necessary, CT RPM requests changes to BG from Huron to align billing designations and cost estimates with Payment Schedule. Based on new information, Huron updates billing designations when required. CT RPM negotiates budget with Sponsor.
Study Team
Study Team:
Submits eProtocol modification if Harmonization requires a revision to ICF.
Huron
Huron Team:
If items were changed from Research to SOC during negotiation, CT RPM will request updated CA from Huron. Uploads revised CA into Huron Communities Portal.
CT RMG
CT RPM:
Once Stanford IRB has approved protocol, completes Harmonization process and as required follows up with Huron, Study Team and/or Sponsor to discuss changes.
Distributes the Final CA workbook to the study team and uploads it to SeRA.
Overview: To ensure billing compliance, after protocol has been approved by Stanford IRB, CT RPM reviews alignment or "Harmonization" of Payment Schedule included within the Clinical Trial Agreement (CTA), IRB approved Informed Consent (ICF) and CA Billing Grid. If required, CT RPM works with Huron, Study Team and/or Sponsor to revise study documents. The CT RPM distributes the Final CA workbook to the study team and uploads the file to SeRA.
Study Team
Study Team:
After Notice of Award (NOA) has been issued, obtains PTA.
Completes the Study Account Request Form in Final Approved CA workbook.
Emails Final CA workbook provided by CT RPM to PFS to request SHC study account/98 account.
Completes the Study Account Request Form in Final Approved CA workbook.
Emails Final CA workbook provided by CT RPM to PFS to request SHC study account/98 account.
Huron
Huron Team:
No action required.
CT RMG
CT CO:
Issues Award Acceptance Notification (AAN) in SeRA.
Overview: After the Notice of Award (NOA) has been issued, Study team obtains PTA from Dept Finance Manager and completes the Study Account Request Form in Final CA workbook provided by CT RPM. To request a SHC study account/98 account, Study Team emails Final CA workbook to PFS:
DL-StudyWorkbook@stanfordhealthcare.org.