How to Register, Schedule and Bill for Clinical Research Study Patients
Effective January 1, 2006, Revised September 1, 2008
Objective:
- To establish billing procedures for patients enrolled in clinical research studies
- Procedures apply to both studies with external sponsors and investigator initiated studies
- To identify clinical and administrative services and charges associated with a clinical research studies and to determine which will be Standard of Care (billed to the patient and/or their insurance) and those Non-Standard of Care (billed to the study sponsor)
PATIENT REGISTRATION
Process:
- When a patient is approved to participate in a Study and will be seen by an SIU billing provider or by research study personnel the patient must be registered in the SIU P&S billing system – Signature unless already an established patient in the system.
- The patient’s complete demographic and insurance information is to be obtained/confirmed and added/updated to Signature.
SCHEDULING APPOINTMENTS and PRINTING ENCOUNTER FORMS
Process:
- Standard of Care (SC): Routine clinical services and items that the patient would receive in the normal course of diagnosing and/or treating their illness were it not for the Study. This will also include any services or items provided to diagnose or treat any complications arising from the patient’s participation in the Study.
- Non-Standard of Care (NSC): Those clinical services and items rendered to patients ONLY because of their participation in the Study and which are not the standard of care in the community.
- Research Coordinators must inform reception staff of the type of appointment and/or type of patient encounter and whether the patient’s insurance will be billed (SC) or if the Study will be the responsible party (NSC).
- If the patient encounter will include both SC and NSC services, two (2) separate encounter forms will be needed.
- Once the patient is registered and the type of clinical service (SC vs NSC) is determined, encounter forms (charge tickets) may be requested and printed
| Standard of Care |
Non-Standard of Care |
| - Schedule the appointment to appropriate case (usually outpatient) |
- Schedule the appointment to the clinical research study special case with case type = X |
| - Patient’s health insurance will be billed |
- If case type = X doesn’t exist, reception must establish a special ‘X’ case prior to scheduling or printing of encounter from |
| - Special handling of the appointment is not needed unless the patent is presenting for a Medicare non-covered service for which an Advance Beneficiary Notice (ABN) must be executed |
- Case type descriptions should include the principal investigator’s provider ID (example: x-study-TT39U) |
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- Special ‘X’ cases should be established with a ‘guarantor only’ scheme. No health insurance will be billed. |
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- A clinical research study guarantor must be established to track activity of patients in the specific study that the Study will pay. Guarantor name and address will be: X,______________ Study, c/o Research Coordinator name, PO Box XXXXX, Springfield, IL 62794XXXX. The address should reflect the study coordinator and his/her respective mail code. |
Billing for Services Rendered to Clinical Research Study Patients
| Type of Service Provided |
Who Do We Bill? |
What Do We Bill Through SIU P&S? |
| |
|
|
| STANDARD of CARE |
Patient insurance and/or patient |
Services are billed based on CPT coding |
| |
|
Assign Q0 and Q1 modifiers:
Q0—Item or service being studied
Q1—Item or service which is Standard of Care |
| NON-STANDARD of CARE |
|
|
| - Professional services by PI or co-PI |
No one. Assign billing and diagnosis codes.
No charge the professional services. |
PI and co-PI services are paid by the STUDY and no P&S billing is appropriate
-only the Study Patient Visit charge if applicable |
| - Professional services by another physician or billing provider who is not a PI or co-PI |
Study/grant using special ‘X’ case |
Appropriate CPT codes are billed, RVUs are paid, and study reimburses no less than 60% of SIU group fee schedule (billed charges) |
| - Services provided by ancillary staff (such as PFTs, infusion therapy, lab, etc.) |
Study/grant using special ‘X’ case |
Appropriate CPT codes are billed, RVUs (as appropriate) are paid, and study reimburses no less than 60% of SIU group fee schedule (billed charges) |
| - Research Coordinators or other non-billing providers who provide provide non-clinical services such as data collection. |
Study/grant using special ‘X’ case |
No professional clinical services are provided and therefore no professional service billing is appropriate.
-only the Study Patient Visit charge if applicable |
STUDY PATIENT VISIT CHARGE---$30.00
Patient appointment is conducted in an owned and/or leased SIU outpatient clinic location. |
Study/grant using special ‘X’ case |
Sercices rendered by any billing or non-billing provider where a professional clinical service was not billed or data collection services by Study personnel. Process the Study Patient Visit Charge using TMID 2000. Study will pay the $30.00 facility/overhead fee. No physician compensation is appropriate. |
- All charges will be submitted on the physician’s clinic encounter form. No special encounter forms will be needed.
- It is suggested that TMID 2000 – Study Patient Visit -- be added to all clinic encounter forms. This is not a billable code to the patient and/or insurance. This code is only used to bill a study or grant for ‘clinic room use’.
- If during the visit, the provider determines that the patient has problems ‘outside the reason for the visit’; such as, seen for ‘protocol follow-up and has a non-related problem’, an additional encounter must be requested and completed to record the cpt code and diagnosis for the non-related problem.
- It is the responsibility of the Research Coordinator to manage any paperwork (including encounters) involved in the registration, scheduling and billing of patients involved in Clinical ResearchStudies.
- All information regarding Standard of Care and Non-Standard of Care visits and charges should be identified on the Billing Compliance Worksheet for each study. The worksheet can be obtained from Erin Campbell.
Procedures setup and track research patients 0106.cm
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