How to Register, Schedule and Bill for Clinical Research Study Patients at SIU
Effective January 1, 2006 and Revised July 1, 2009
     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 study and to determine which will be billed to the patient and/or their insurance (including Medicare) and those 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 P&S 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. Whether a new or established patient in Signature additional registration requirements are necessary as detailed below.
• 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 (SOC):  Routine clinical services and items that the patient would receive in the normal course of diagnosing and/or treating their illness regardless of their enrollment in a Study. If a patient is enrolled in a Study, SOC 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
• 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 or if the Study will be the responsible party to pay
• If the patient encounter will include both types of billings, insurance and Study, two (2) separate encounter forms will be needed
• Once the patient is registered and it is determined which responsible party (insurance vs. Study) is responsible for payment, encounter forms (charge tickets) may be requested and printed

                     Standard of Care----insurance to be billed                           Non-Standard of Care-----Study to be billed  or
                                                                                                                        Standard of Care----but Study to be billed  

Billing for Services Rendered to Clinical Research Study Patients

60% Negotiated Fee---If a reduced fee has been negotiated with the Study sponsor and SIU P&S has agreed to the discount then the discounted charge amount needs to be reported on the encounter form (charge ticket) next to the CPT code so that the charge posting staff will know to override the standard charge amount. 

Additional Billing Requirements:

• All charges will be submitted on the physician’s standard 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 their insurance.  This code is only used to bill a study or grant for the ‘clinic room use’ charge.
• If the visit includes multiple services with some being billed to the patient’s insurance and others to the Study, then two (2) encounter forms will need to be requested.
• 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-Study related problem. These later services will be billed to the patient’s insurance.
• 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 Research Studies.
• All information regarding Standard of Care and Non-Standard of Care visits and the associated responsible payer for each service charge should be identified on the Billing Compliance Worksheet for each study. The worksheet can be obtained from Erin Campbell.

 MEDICARE Patients Only and Where MEDICARE is to be Billed:

• Special Medicare modifiers are to be appended to all CPT codes that will be billed to Medicare as follows:

• Q0---this modifier is to be appended to each CPT code where the item or service being billed is what is being investigated as an objective of the Study.
• Q1---this modifier is to be appended to each CPT code that is considered the Standard of Care (see earlier definition) and where the service will be billed to Medicare.

Example: Patient is enrolled in a device Study and the device placement is to be billed to Medicare. In addition to the device placement there was also a Hospital Visit and Angiogram service provided which are considered to be Standard of Care services. All services for this encounter form will be billed to Medicare. Appending the Medicare specific modifiers would be as follows:
            Device Placement                  37215-Q0        (device is objective of Study)
            Angiogram                              75660-Q1        (Standard of Care)
Hospital Visit                           99232-Q1        (Standard of Care)
           

• Special Medicare diagnosis code V70.7
• When modifier Q0 or Q1 is reported on the encounter form (charge ticket) a special Medicare diagnosis code is also to be reported. Reporting it as a “secondary” diagnosis code on the Medicare insurance claim is important and special attention should be given to assure its proper placement on the insurance claim form.

You designate as a secondary diagnosis as follows:   Secondary DX    2-V70.7