I. Access to Billing Matrix
You must complete an online training course prior to being given access to this system. Please contact Billing Matrix IT at BillingMatrixITHelp@wustl.edu
II. Purpose of the Billing Matrix
The Matrix was developed as a tool to identify clinical study participants and to serve as a potential roadmap to direct clinical trial billing activities. Charges for studies must either be directed to the participant’s insurance company as a Standard of Care (SOC) or routine charge, or to the Principal Investigator/Sponsor as an Investigational (INV) charge. The Matrix will show the timeline of the study, and what procedures are SOC or INV is indicated. When reviewed, in conjunction with other clinical research billing documents and tools, the Matrix can direct billing procedures within a study to the correct entities.
Your responsibility is to enroll participants of a study into the “Enroll a Patient” section of the Matrix. We require the last name, first name, DOB, and date of consent to enroll each participant. Please follow-up by adding the participant’s address, date of first clinical service, gender, race, ethnicity, and last 4 digits of SS# which are not required for enrollment, but desired for billing clarification issues. When the patient has completed their participation, we ask that you return to the enrollment section of the Matrix and enter the participants ‘end date’ (last date of participation in the study), and the reason – completed, screen failed, or dropped. This will stop the hold on bills for that participant.
For studies that are deemed to have high billing risk, this is a mandatory requirement from the Washington University School of Medicine administration.
The Matrix is covered under the blanket permission for confidentiality exception, which can be found in the “How will you keep my information confidential?” section of every Informed Consent. This section describes who would have access to this information in the bullet “Hospital or University representatives, to complete Hospital or University responsibilities.” The Billing Matrix falls under this category.
IV. How to enter participant information in Billing Matrix
Participants need to be enrolled in a study within one business day after they sign the Informed Consent.
The End Date is when your participant is completely finished with all study related procedures including every aspect of follow up. If, for example, your study timeline has phone follow-ups for 5 years, then this participant will not receive an end date until the last conversation is performed 5 years later.
No. Once a participant is entered into a study, they remain in that study; they should never be unenrolled.
When a participant completes the requirements for the study, the End Date is entered.
In this instance the Consent Date, the Date of First Clinical Service, and the End Date would be the same date.
Yes. There are a few scenarios for which this requirement is waived. A decision tree that covers most of these scenarios has been created and is posted on the Billing Matrix page. If you are questioning whether subjects need to be enrolled, you can consult this decision tree and contact the Clinical Research Billing Support office at firstname.lastname@example.org.The Clinical Research Billing Support office makes this decision.
You are allowed to view only the Matrix and the Profile page. If you believe something is incorrect in the Matrix or the Profile section, and needs to be altered, please contact the Matrix team at email@example.com. We will discuss it and if needed, we can make the change.
No. This is not a HRPO/research violation as providing this information is a necessary University function.
You do not need additional IRB approval. The informed consent form has been approved by the IRB and addresses the use of such personal information. The HIPAA section in the consent discusses the types of access, use and disclosure of a participant’s protected health information or personal information in the study. It specifically states, in part, that: “The research team will follow state and federal laws and may share your information with:
- Government representatives, (including the Office for Human Research Protections or the Food and Drug Administration) to complete federal or state responsibilities
- Hospital or University representatives, to complete Hospital or University responsibilities
An individual is “engaged in human subject research” if s/he has contact or interactions with human research participants or research data involving human participants. The HRPO submission form requests the names of engaged members of the study team.
We are requesting a copy of the budget to find out which services and procedures are intended to be paid for by the study sponsor. We want to be able to provide, if audited, not only the rationale behind our designations of INV or SOC, but justification that we are not double billing for any services. We do not need to see salaries or dollar amounts for procedures, but it would be helpful to know the facility and the location where the procedure will take place (e.g., the imaging scan will be done at CCIR, BJH Radiology department or the East Building), and who is paying for it.
Contacts for the Billing Matrix
Mgr, Clinical Research Billing
Clinical Research Billing Sup Analyst
Assistant Dean Clinical Studies