1. Pediatric EducAtion Research Lunch Series (PEARLS)
Research Billing Compliance
October 14, 2016

2. Overview
Research Billing Compliance: Ensuring subjects (or their third party payers - insurance companies, Medicare, Medicaid) are not charged for any research related activities.
If not managed, could lead to:
Double billing
Insurance fraud
False Claims Act
Federal Investigation
There are serious consequences, even if non-compliance was unintentional

3. Your Role Research Coordinator Coverage Analysis
Budget Development
Verifying invoices for patients
Verifying invoices for sponsors
Verifying invoices for subcontractors
Identifying subjects enrolled in research
Identifying clinical visits with research activities

4. Step 1: Laying the ground work
Coverage Analysis (CA)/Prospective Reimbursement Analysis (PRA):
CHOA and Emory have policies and staff in place to identify all activities that cannot be billed to 3rd Party Payers (this is not the same as determining what is standard of care or not). Medicare/Medicaid is used as the standard.
Research budget development:
Financial staff use the CA/PRA to put together a budget for the sponsor covering all research costs and fees. 3 basic categories:
Billable Items – activities that occur in a clinical setting that have a CPT code (radiology, procedures, labs, examinations, etc) – these are charges that would normally go to 3rd party payers
Administrative fees – set internal costs associated with research set up (IRB, Pharmacy start up, document storage, etc)
Effort – percentage of research staff and PI salaries reflective of time spent running the study
( This step occurs once you submit your study to Research Administration: )

5. Step 2: Identifying Research Subjects and Visits
Subjects enrolled at CHOA (any PI): complete the Project Enrollment Tracker
Note: Aflac has a different process – please contact your team lead
Subjects with an Emory PI: enter subject in ERMS the day of consent
Identifying Research Visits:
(this is NOT required for routine/standard of care items)
Research Billable items at CHOA:
Complete the Research Pre-registration form 24 hours prior to visit
Complete the Patient Billing Tracker within 24 hours after visit
Research Billable items at Emory:
Track Visit in ERMS within 3 days of visit

6. Step 3: Confirming Research Charges
Multiple people may ask you to verify research charges or activities:
Group
Reason
CHOA Office of Grants and Accounting (OGA)
Verify which CHOA billable items go to subject/third party payer vs. research account
CHOA Research Administration
Confirm what research charges (billable items, administrative fees, effort) CHOA invoices to sponsor or subcontractor
CHOA Ancillary Departments (IDS, Sibley, PRC)
Verify their services should be charged to research account
Emory Research Administration Services (RAS)
Confirm what research charges (billable items, administrative fees, effort) Emory invoices to the sponsor or subcontractor
Emory Healthcare Clinical Trials Billing Department
Verify which Emory billable items go to subject/third party payer vs. research account

7. EPIC Research EPIC Research is rolling out: 10/25/16 PRC
11/15/16 Aflac
Others coming soon

8. Panelists Chee-Chee Manghram Manager, CHOA Research Administration
Shakeeta Nicholson, MBA, MPM
Manager, CHOA Office of Grants Accounting
Leslie Smitley, RN, MSN, CCRC
CICU/Cardiac Lead Research Nurse, CHOA
Courtney A. Fyock
Sr. Clinical Research Coordinator, CHOA
Janice Newman, MBA
Sr. Applications Analyst, CHOA Research Technology
Mike Cottrell

9. Questions How and when do I register/track a subject in ERMS?
Enrollments are entered the same day as consent
Visits are tracked (within 3 days of visit occurrence) only if there are Emory billable items.
Log in, training information and user guide can be found here:

10. Questions
How and when do I enter information into the Project Enrollment Tracker?
The Project Enrollment Tracker is the tool used to track enrollment.
Mirrors the budget: it is a version of the actual budget with a row inserted to add visit dates.
Each individual sheet should have its own subject ID: for each subject, copy and paste the template or blank spreadsheet into a new sheet and label it with the Subject ID
Indicate the date of each visit
Make note of any missing procedures: If at any time a procedure that is required for that visit DID NOT happen – you should make a note somewhere or highlight that field to alert OGA that that procedure did not occur to ensure they do not invoice for that service on that visit.
Should be updated on the day of the visit but HAS to be updated monthly
Note: Aflac has a different process – please contact your team lead

11. Questions Where is my Project Enrollment Tracker located?
The Project Enrollment Trackers are located on CHOA’s shared drive: P:\Clinical Research\Project Enrollment Tracking. If you are an Emory Coordinator you will follow the following steps:
Log in to CHOA’s RCAP (the same as you would to access Epic)
You will see a file titled “Share Drive”
The file is titled:  P:\Clinical Research\Project Enrollment Tracking
All files are saved as: PI Last Name – Short Title of study
Note: Aflac has a different process – please contact your team lead

12. Questions
Who do I contact when a subject receives a medical bill for research procedures?
Patient needs to contact Patient Financial Services who will in turn contact OGA and work to get the charges moved to the research account
Important to complete the patient billing tracker on the front end to avoid this
Tip: communicate upfront that it if the patient receives a bill that they should contact you and let you know. Also clarify any standard of care procedures (that will generate a bill)
If patient gets a bill on the Emory side, contact OCR and they will put you in touch with Emory Healthcare Clinical Trials Billing Department.

13. Questions Where and when do I submit the Pre-registration form?
The CHOA Pre-registration form must be submitted within 24 hours of the visit if the visit has patient care billables that should be charged to the study. It can be found at
Can be done after the visit if you aren’t sure if they are part of a study (or if enrolled during a visit)
Studies using EPIC research won’t need to use this
if appointment changed or canceled

14. Questions Where and when do I submit the Patient Billing Tracker?
The Patient Billing Tracker will come from OSP via Grants Administration. It will be included in the NOA package.
Patient Billing Trackers must be submitted within 24 hours of the visit to
If Sibley services are involved (EKG/echo), cc Heather Friedman

15. Questions Who do I contact when I have a billing compliance issue?
CHOA: Contact OGA
Emory: Contact OCR

16. Questions
How will EPIC Research impact/change research billing compliance?
The new EPIC Research Functionality will allow:
Research patients to be enrolled and clearly identified in EPIC.
Allows all charges (research and routine) to be held for review.
Better reporting on research patient information.
Better reporting on research billing information.
Compliance with research information on the billing claims.
More streamlined process for the research team.

17. Audience Questions/Comments
Question: What if a subject will be seen at CHOA but there are no research billable items (study is following routine care)?
Still submit to CHOA research administration for a coverage analysis to be sure.
Comment: Pharmacy, ancillary departments and research processing will not be in EPIC, they have their own ways of invoicing that will remain the same
Comment: Ways that CHOA knows about the number of research patients:
Submit IRB Authorization Agreement (IAA) form to CHOA IRB
Monthly enrollment/visit tracking in REDCap (Research Clinical Trials 2016)

18. Contact Information
Chee-Chee Manghram Manager, CHOA Research Administration , Shakeeta Nicholson, MBA, MPM Manager, CHOA Office of Grants Accounting , Leslie Smitley, RN, MSN, CCRC CICU/Cardiac Lead Research Nurse, CHOA ,
Courtney A. Fyock
Sr. Clinical Research Coordinator, CHOA ,
Janice Newman, MBA
Sr. Applications Analyst, CHOA Research Technology ,
Mike Cottrell
Sr. Applications Analyst, CHOA Research Technology ,