Coverage Analysis
Process For Grants
Welcome to the Coverage Analysis Process page for Grants.
Click on the plus sign to expand a step. An Overview provides a summary description. Click on the flip cards to learn more about the role you play in the Coverage Analysis process.
Study Team
Study Team:
Collects all essential protocol documents.
Reviews protocol procedures and considers study logistics (ie. use of CTRU).
Submits protocol to IRB.
Ankura
Ankura Team:
Sends report of IRB assigned SHC patient studies to RMG on Monday morning.
Central Office
RMG Director:
Reviews IRB report to identify grant-funded studies in scope for CA and sends back to Ankura within 24 hours with RPMs identified.
Overview: Study Team submits protocol to IRB. Ankura sends report of IRB assigned SHC patient studies to RMG on Monday morning. RMG Director reviews IRB report to identify grant-funded studies (including subcontracts) in scope for CA and sends back to Ankura within 24 hours with RPMs identified.
Study Team
Study Team:
No action required.
Ankura
Ankura Team:
If CA is required, Ankura downloads essential study documents from eProtocol and SeRA. (i.e Protocol, Informed Consent (ICF), Sponsor’s payment schedule).
If CA is not required for a study, Ankura will notify RMG, PFS and the study team.
Central Office
RPMA:
If CA is not required for a study, Ankura will notify RMG, PFS and the study team, and RPMA will note the active SeRA transaction.
Overview: If CA is required, Ankura downloads essential study documents from eProtocol and SeRA (i.e Protocol, Informed Consent (ICF), Sponsor’s payment schedule). *If CA is not required for a study, Ankura will notify RMG, PFS and the study team, and the active SeRA transaction will be noted by RMG.
Study Team
Study Team:
If any essential documents are missing, Study Team will be notified by Ankura. Study team emails necessary documents to Ankura. CA is considered on hold until all necessary documents are made available to Ankura.
Ankura
Ankura Team:
If all necessary documents are available, Ankura will email Coverage Analysis start notification to Study Team and RPM. Draft CA 10 day clock begins.
Central Office
RPM:
Once 10 day clock begins, RPM attaches Ankura CA start email to active SeRA transaction.
Overview: If all necessary documents are available, Ankura will email Coverage Analysis start notification to Study Team and RPM. Draft CA 10 business day clock begins. If any essential documents are missing, Ankura will notify RPM and PI/Study team of missing document(s) and CA is put on hold until all required documents are available. RPM attaches Ankura CA start email to active SeRA transaction.
Study Team
Study Team:
Upon receipt of Draft CA from Ankura, PI/Study Team reviews billing for each clinical service. Provides feedback to Ankura via Study Team Review Checklist within Billing Grid (BG):
- Confirms Billing Designation
- Validates hospital service billing codes and number of occurrences
- Replies to questions (red text box) posed by Ankura
PI Study team notes approval or requested revisions within "Study Team Review Checklist" and emails it to Ankura, cc RPM. Study Team approves revised CA and emails it to Ankura, cc RPM.
Ankura
Ankura Team:
Ankura sends Draft CA to PI/Study Team and RPM.
If revisions are required, Ankura updates CA per PI/Study Team feedback and returns for approval.
.
Central Office
RPM:
If needed, RPM is available to facilitate meeting between Ankura and PI/Study Team to confer on CA.
.
Overview: Ankura sends Draft CA to PI/Study Team and RPM. PI/Study Team reviews billing for each clinical service. Provides feedback to Ankura via Study Team Review Checklist within Billing Grid (BG):
- Confirms Billing Designation
- Validates hospital service billing codes and number of occurrences
- Replies to questions (red text box) posed by Ankura
RPMs can coordinate a Coverage Analysis Review Meeting (CARM) between the PI/Study Team, Ankura and RPM to discuss the draft CA review and approval, if needed.
PI Study team notes approval or requested revisions within "Study Team Review Checklist" and emails it to Ankura, cc RPM. If necessary, Ankura updates CA per PI/Study Team feedback and returns for approval. PI/Study Team emails approval to Ankura and cc RPM.
Study Team
Study Team:
If necessary, PI/Study Team works with RPM to address budget gap.
PI/Study Team reviews and approves revised CA. Sends email approval to Ankura and RPM.
.
Ankura
Ankura Team:
Ankura emails Initial Approved CA to PI/Study Team, RPM and PFS.
If a gap is idenitified which impacts CA, Ankura updates Initial Approved CA and returns it to PI/Study Team for approval, and cc RPM and PFS.
.
Central Office
RPM:
Confirms feasibility of study based on alignment between CA and proposed study budget.
RPM notifies Ankura no changes are needed or that a budget gap has been identified. RPM addresses budget gap with PI/Study Team.
Once gap is addressed, RPM notifies Ankura.
RPM uploads Initial Approved CA to active SeRA transaction.
Overview: RPM confirms feasibility of study based on alignment between CA and proposed study budget. RPM notifies Ankura no changes are needed or addresses budget gap with PI/Study Team. Once gap is addressed, RPM notifies Ankura. Ankura incorporates any changes to the CA and emails Initial Approved CA to PI/Study Team, RPM and PFS. RPM uploads Initial Approved CA to active SeRA transaction.
Study Team
Study Team:
PI/Study Team receives AAN in SeRA.
Ankura
Ankura Team:
Ankura receives AAN in SeRA.
Ankura reviews CA, Informed Consent and funding documents to ensure alignment. If necessary Ankura revises Initial Approved CA to align with other documents.
Central Office
RPM / CGO:
Issues AAN in SeRA with a cc to the Ankura Team at: nvisyak@stanford.edu and sfakhr98@stanford.edu.
Overview: RPM / CGO issues AAN in SeRA with a cc to Ankura. Ankura reviews CA, Informed Consent and funding documents to ensure alignment. If necessary Ankura revises Initial Approved CA to align with other documents.
Study Team
Study Team:
PI/Study Team receives Final Approved CA from Ankura.
Emails Final Approved CA workbook to PFS to request SHC study account/98 account.
Ankura
Ankura Team:
Ankura emails final/approved CA to PI/Study Team, RPM / CGO and PFS and uploads to active SeRA transaction.
Central Office
RPM / CGO:
Receives Final Approved CA from Ankura. No further action required.
Overview: Ankura emails final/approved CA to PI/Study Team, RPM / CGO and PFS and uploads to active SeRA transaction. Study team Emails Final Approved CA workbook to PFS
(DL-StudyWorkbook@stanfordhealthcare.org) to request SHC study account/98 account.