1. Clinical Trial Billing and Patient Remuneration
Barbara Gallagher, RN
Clinical Research Nurse
Jefferson Clinical Research Institute

2. Learning Objectives:
List two documentation requirements for patient remuneration
State three examples that explain why accurate clinical trial billing is important
Describe what a Coverage Analysis grid is

3. Patient Remuneration
Required to obtain a W-9 from the subject if some type of payment will occur
Cash
Check
Gift card
**Reimbursement
W-9 must be done annually (calendar year)
IRS requires an individual to report remuneration over $600 in a calendar year as income (i.e. Taxable)
Institution will send a 1099 to the subject, they then have to report it to the IRS
Reimbursement is considered a payment unless the subject shows proof of expenses (parking ticket, tolls, etc.)

4. Patient Remuneration Process
Obviously different for each Institution
Work with your Grant Administrator and Business Administrator
@Jefferson = Greenphire ClinCard
JCRI – Erica Brown
Minimum Requirements:
Maintain a log for each study of payments made
Obtain documentation of payment transactions
Signed by Subject and Study Coordinator
Store in source documentation

5. Clinical Trial Billing
Ensure compliance with Federal, state, and local regulations
Minimize patient billing errors and/or patient dissatisfaction
Optimize cost recovery
Minimize denials and/or claims processing errors
Encourage participation in research activities through transparency and integrity
Communication between all servicing areas is integral to correct and compliant Clinical Trial billing

6. Institutional Roles/Responsibilities
Research Administration/Grants Administrator (JCRI)
Facilitate relationships between faculty investigators sponsors
ensure sponsored projects are administered in accordance with federal/state regulations, institutional policies and contract
Work with appropriate departments to facilitate revenue cycle functions
registration
charge entry
Coding
claim submission to appropriate payors
accounts receivable follow-up.

7. Institutional Roles/Responsibilities
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
grant/sponsor
third party payor (insurance)
research participant

8. Clinical Trials Billing Compliance
Services reimbursed by study sponsors CAN NOT be billed to third party payors.
Third party payors will pay for services
accepted as standard of care
However, frequently exclude payment for experimental or investigational services
Study participants should be aware of any out- of-pocket costs that may result from study participation

9. Coverage Analysis aka MCA (Medicare Coverage Analysis)
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

10. Why is a Coverage Analysis important?
Reduces risk for submitting false claims
Billing for items and services paid for by Sponsor
Billing for research only items and services
Billing for services not part of a qualifying clinical trial
Assists in budget negotiations with Sponsor
Identifies costs that need to be accounted for in the sponsor budget
Basis of billing compliance audits
Provides evidence of due diligence and a mechanism for compliance with billing rules

11. Coverage Analysis Process
Receive all materials from the study team
Protocol, Draft Informed Consent (ICF), Clinical Trial Agreement (CTA), proposed Sponsor Budget
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 to PI/SC for review and approval
Approve or revise as necessary

13. Pre-Award Process Develop and negotiate budget
Review and negotiate clinical trial agreement
Execute agreement
Send for account establishment
Share the approved CA with:
PI/Coordinator/Department
Initiate appropriate clinical billing and business services

14. Post-Award Process
Services r/t research get billed to grant or insurance
Review of billing and compliance grid
Hospital or facility charges
Physician professional fees
Technical fees (Scans, labs ECGs, etc.)
Coding for services r/t Clinical Trial
Medicare’s Clinical Trial Policy and Investigational Medical Device Regulations require specific codes and modifiers be added to claims for processing and segregation of research charges