REVISED   July 1, 2009
                                                            For Additional Information

                                    Patient Registration or Billing            Todd Bahlmann          5-4966
                                    Coding or Charge Entry                     Greta Ryan                  5-7876
                                    Billing Compliance                             Peter Cadwell             5-2110

To:       Research Coordinators
            Principal Investigators

From:   Greta Ryan
            Director, Coding and Charge Posting

Peter Cadwell                                                 Todd Bahlmann
Chief Compliance Officer                              Director, Patient Business Services

RE:      SIU Billing for Clinical Research Study Patients

Attached you will find two documents which relate to the billing processes for patients enrolled in either sponsor supported or investigator initiated clinical research studies and trials. These procedures and processes only relate to those clinical and/or administrative services which will be provided by faculty and staff of SIU and which will be billed through the SIU P&S billing system. The primary document, How to Register, Schedule and Bill for Clinical Research Study Patients, has been updated since initially released in January 2006. The second document is a diagram of the billing process.

The primary changes to the existing processes relate to the need to capture new procedure code modifiers and diagnosis code for patients whose insurance coverage is Medicare. A description of each of the documents and the revised billing requirements follow.

How to Register, Schedule and Bill for Clinical Research Study Patients:

As stated earlier there have been a few revisions to the 2006 document, primarily related to the new Medicare billing requirements related to procedure code Modifiers and Diagnosis code. These new requirements only relate to those study patients that have Medicare as their insurance and where you intend to bill Medicare. If the patient does not have Medicare or the study sponsor is going to pay for these services these new requirements do not apply. The best indication as to whether a patient has Medicare coverage is to consider their age. If they are 65 years of age or older they will have Medicare coverage and then these new billing requirements will apply.

Modifiers: Q0 and Q1

Q0---this modifier is to be added to each procedure code where the item or service being billed is what is being investigated as an objective of the study. For example, if the study is to determine the safety and effectiveness of a device and the device will be billed to Medicare then you would add the Q0 modifier to that specific billing code.

Q1---this modifier is to be added to each procedure code which is considered to be the Standard of Care for the patient’s condition. Standard of Care services are 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 also includes any services or items provided to diagnose or treat any complications arising from the patient’s participation in the Study.

Study Diagnosis Code: V70.7   

V70.7---when the Q0 or Q1 modifier is reported, a special Medicare specific diagnosis code is to be added to the clinical service encounter form as a secondary diagnosis.

You designate the secondary diagnosis code on the clinic encounter form (charge ticket) as follows:   2-V70.7  The lead number of 2 designates the data entry sequence to the billing system.

Thank you and should you have any questions or if you would like for an in service to be presented at a department or division meeting please let one of us know and we’ll make arrangements to attend.

Cc:       Sandra Puczynski, PhD
            Erin Campbell
            Assistants to the Clinical Chairs
            Coding Users Group