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 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 t/integrity/irb/clinical-research- billing.cfm
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)#