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

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

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

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: https://www.choa.org/research/professional-resources )

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

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

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

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

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: http://www.ocr.emory.edu/erms/index.html

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

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

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 (OCR@emory.edu) and they will put you in touch with Emory Healthcare Clinical Trials Billing Department.

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 https://www.choa.org/research/visit-preregistration-form 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 Email OGApatientcare@choa.org if appointment changed or canceled

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 OGApatientcare@choa.org If Sibley services are involved (EKG/echo), cc Heather Friedman (heather.friedman@choa.org)

Questions Who do I contact when I have a billing compliance issue? CHOA: Contact OGA (OGA@choa.org) Emory: Contact OCR (OCR@emory.edu)

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.

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 https://www.choa.org/research/institutional-review-board/forms Monthly enrollment/visit tracking in REDCap https://redcap.choa.org/redcap/ (Research Clinical Trials 2016)

Contact Information Chee-Chee Manghram Manager, CHOA Research Administration 404-785-9496, chee-chee.manghram@choa.org Shakeeta Nicholson, MBA, MPM Manager, CHOA Office of Grants Accounting 404-785-9379, shakeeta.nicholson@choa.org Leslie Smitley, RN, MSN, CCRC CICU/Cardiac Lead Research Nurse, CHOA 404.785.2215, leslie.smitley@choa.org Courtney A. Fyock Sr. Clinical Research Coordinator, CHOA 404.785.1403, courtney.fyock@choa.org Janice Newman, MBA Sr. Applications Analyst, CHOA Research Technology 404-785-8228, janice.newman@choa.org Mike Cottrell Sr. Applications Analyst, CHOA Research Technology 404-785-6885, Michael.cottrell@choa.org