1. Ensures that studies are billed for research specific procedures

2. Institutional Roles/Responsibilities Jefferson Clinical Research Institute (JCRI) Facilitates the relationship between TJU faculty investigators and the various sponsors of scientific and scholarly knowledge; ensuring sponsored projects are administered in accordance with sponsor regulations and TJU policies. Physician Business Services (PBS) Provides central revenue cycle functions including registration, charge entry, coding (for certain clinical departments), claim submission to payors and accounts receivable follow-up. Jefferson University Physicians (JUP) and Thomas Jefferson University Hospital (TJUH) Provide clinical services to patients including research participants. Principal Investigator (& his/her designee) Complete required documentation to support charges for each research participant. Accurately bill medical professional and technical research charges to appropriate payor source (e.g., grant; third party payor; or to the research participant).

3. Clinical Trials Billing Compliance Services reimbursed by study sponsors CAN NOT be billed to third party payors. Third party payors usually only pay for services that are accepted in the medical community & frequently exclude payment for experimental or investigational services. Study participants should be aware of any out- of-pocket costs resulting from participation in the study.

4. Medicare Coverage Analysis (MCA) Medicare Coverage Analysis / Compliance Grid is a document that determines the appropriate payor (i.e. Sponsor, Medicare or third party payor) for each item and service required by a clinical research trial JCRI receives all study materials from the study team Create a grid that reflects all clinical events and time points in the protocol Review clinical guidelines along with CMS (Centers for Medicare & Medicaid Services) national and local coverage determinations to identify the appropriate payor for each event Send the MCA to PI/SC for review and approval Approve or revise the MCA as necessary

6. Clinical Trial Billing Entities Jefferson University Physicians (JUP) Bills related to clinical services sent monthly from JUP Business Services Hospital Bills related to clinical services sent regularly from Hospital Business Services

7. Jefferson University Physician (JUP) Bills -Physician professional fees -Examples: Physical exam, evaluation of MRI, ECG interpretation, etc. -Services get billed to grant or patient’s insurance for JUP services. Review billing and compliance grid as reference -Contact for JUP Billing - Merle Charlton, 3-3311

8. Hospital Bills Technical Fees for clinical trial services i.e. MRI cost, CT scan cost, some clinical labs, ECG cost, etc. Billed to grant or patient insurance as designated by billing and compliance grid Contact for hospital billing Ed Dunigan, 5-2521

9. Clinical Trial Billing Process Create a Clinical Trial Case with the JUP Business Office/ Registration. A Case Number will be assigned.

10. Clinical Trial Billing Process The Case Number will be part of the Patient record in the IDX section of Allscripts All Procedures completed at Jefferson as part of the Clinical Trial need to have the Case information attached to the Appointment and Orders/Prescription (if applicable) The Orders/Prescription paperwork must have the Case Number listed, and MUST be stamped with “Clinical Trials”

11. Clinical Trial Billing Process

12. Clinical Research Coordinator’s Role Keep the billing and compliance grid available JCRI and the Billing Departments will use the grid to determine if the procedure should be billed to the grant (clinical trial) or to patient insurance Be prepared to answer questions your Clinical Research Administrator may have