Clinical Research Billing Schedule workflow

1. Clinical Research Billing Schedule workflow Melanie Hawkins, BSN, RN, CCRC Director, Clinical Research Billing Compliance Kristin Couture, CCRP Clinical Research Coverage Analyst

2. Key Points with New Billing Schedule • Must be used for all new eIRB submissions that involve clinical services • Every protocol-driven clinical service required by the protocol must be listed – even if everything will be paid for by the study sponsor • Do not list any clinical services not required by the study protocol (i.e. standard of care not specifically stated in the protocol) • Every protocol-driven service must be coded based on how it should be billed: • INS for insurance • RES for research industrial account • NC for no charge #

3. Finer Points with New Billing Schedule • Procedures that are part of inclusion/exclusion criteria (e.g. a surgical procedure) should not be listed • Screening/baseline services should be listed • Screening/baseline services performed strictly for study purposes cannot be billed to INS • Professional fees generally do not need to be listed as a separate line item • Note if radiology service will not require read • List professional fee if there will not be associated hospital fee (e.g. cardiologist read of ECG done on sponsor-provided machine) #

4. Finer Points continued… • Note if NC services will be performed in CTRC • For VA/OHSU studies, list only those services performed at OHSU • Make a notation “All other services will be performed at VA” • If lab tests will be performed centrally, note “Central labs” as one line item and list tests on same line • Not necessary to have separate line items for each test More information is better… #

5. CRBO Review of Billing Schedule • Billing Schedule part of eIRB submission • CRBO to begin billing review at time of submission • CRBO will communicate directly with study team about any needed revisions to Billing Schedule • Comment in eIRB Project Log: “CRBO Billing Schedule PENDING – Contacted Study Team” • CRBO to approve final schedule and email IRB analyst • Comment in eIRB Project Log “CRBO Billing Schedule APPROVAL” • IRB Analyst to notify CRBO if additional revisions submitted • CRBO to confirm approved Billing Schedule in eIRB prior to IRB study approval #

6. CRBO Review continued… • Prospective Reimbursement (Qualifying) Analysis performed • CRBO to ensure “Insurance Billing” page in IRQ is correct • Will revise if necessary and enter comment in eIRB Project Log • Consent review • Does it match billing schedule? • New boilerplate being developed • CRBO to notify IRB analyst of requested revisions • IND/IDE portion of IRQ • CRBO to notify IRB analyst of any errors/inconsistencies #

7. Questions? Call the CRBO with ANY questions about billing for clinical services on a study. It can be complicated and we want to help! • Clinical Research Billing website http://www.ohsu.edu/xd/research/about/integrity/irb/clinical-research-billing.cfm • Email CRBO@OHSU.edu • Contacts: • Kristin Couture, Clinical Research Coverage Analyst, x4-4790 • Melanie Hawkins, Director, Clinical Research Billing Compliance, x4-8586 #

8. Sample Schedule of Events(from protocol) #

9. Clinical Research Billing Schedule #

10. Clinical Research Billing Schedule (continued) #