Prior to a study being active at ECU Health, a Coverage Analysis/Financial Services Review Form is done to determine the appropriate payer (i.e., sponsor, Medicare or third-party payer) for each item and service required by a clinical research trial. This review form analyzes how study services will be paid and what is needed.

Services related to a research study can be paid by:

1. The study – This could be an industry sponsor, grant or the department.
2. The insurance – Study-related clinical services are standard of care and would be provided to the research participant even if not on a clinical research study. For example, if a participant has a diagnosis of cancer, he/she would likely get chemotherapy, in or outside of a study. These services are usually billed to the research participant or his/her insurer. However, they can be billed to the research study with prior agreement. Please note that sponsors must agree to pay for all participants the same way and are prohibited from paying for some patients but not others.
3. Both, the study and insurance – In many cases, the study will pay for services that are strictly research, and insurance will pay for what is considered “standard of care.” The determination of who pays for what is done based on Medicare rules, the protocol, the contract, budget, and other documents.

Treatment of adverse events resulting from participation in the study may be the responsibility of the patient, the patient’s insurer or the sponsor, depending on the agreement between the sponsor and the institution. (Refer to the informed consent and the clinical trial agreement for the study.)

Billing Medicare (and any other third-party payer) for items and services that are part of a research study must be undertaken very carefully. Decisions on who will be responsible for various costs of study procedures and services should take place early, before any patients are enrolled and before any charges are incurred.

Research Pricing

Research pricing is done by the research specialist for finance. The study coordinator or principal investigator requests research pricing with necessary services and procedures listed with CPT codes. The requests are sent to the regulatory research specialist for clinical trials.

Clinical Trial Participant List (CTPL):

The Clinical Trial Participant List is a form designed to differentiate billable procedures completed on an ECU Health campus and paid by the study/sponsor or part of the patient’s standard of care procedures.

External study team members are responsible for completing this form for every patient visit and submitting it via email as instructed on the form. Our finance team will review and update patient billing records accordingly, to ensure billing compliance.

When do I send the Clinical Trial Participant List?

• Initial Submission: Time of Participant Consent
  • Study team members should submit the initial Clinical Trial Participant List (CTPL) to all email addresses on the CTPL at time of consent.
• Ongoing Submission: Every Patient Visit (as required per study protocol)
  • For inpatients, please submit the CTPL as soon as possible (prior to hospital discharge) to all email addresses on the CTPL.
  • For outpatients, please submit the CTPL at least 24 hours prior to the outpatient visit to all email addresses on the CTPL.

When research services are done, the study coordinator should submit a Clinical Trial Participant List to [email protected] to ensure that all services are billed correctly and that it indicates whether it is sponsor paid or standard of care.

Sponsor/Designee Visits at ECU Health:

The Center for Research and Grants is the central hub for scheduling sponsor/designee visits (i.e., pre-study, site initiation, monitoring, etc.) on an ECU Health campus. External study team members should contact us via email to schedule sponsor/designee visits ([email protected]).

Please be sure to include the following in the email:

• Study name/UMCIRB #
• Sponsor/Designee
• Potential dates and times of the visit
• Type of visit
• ECU Health departments to be included

Informed Consent Upload in Patient’s Medical Record:

External study team members must send the signed research informed consent for upload to the research participant’s medical record prior to procedures on an ECU Health campus. This is for audit compliance and ensures that clinical staff involved in patient care are aware of research participants on their unit. The Center for Research and Grants will assist with uploading the informed consent into every patient’s medical record. Please submit the signed informed consent to [email protected].

Research Flag

A Research Flag is an identification tool within the Epic EHR to notify clinical staff that the patient is participating in a research study. This flag will provide the basic study background and contact information or “smart phrase” for the clinical trial, and will be applied to all ECU Health patients who have signed a clinical trial informed consent. The Center for Research and Grants will assist with application of the research flag onto every patient’s medical record once the informed consent is received.

What information is needed to create the smart phrase for my study?

• Study short name:
• NCT #:
• Description: ECU Health is participating in a study of “…”. Participants in this study may be receiving “…”
• Contact:  If you have any patient care concerns potentially related to study, please contact “Name” (study coordinator) at “phone” or “Name” (Principle Investigator) at “phone.”

When and to whom do I submit information needed for the smart phrase?

Smart Phrase requests are to be submitted within 24 hours of IRB approval/acknowledgment to [email protected].

A final Clinical Trial Participant List (CTPL) and email should be sent to [email protected] when a study comes to the end.

When the trial is closed, email [email protected].