Frequently Asked Questions for the Billing Matrix
I. Access to Billing Matrix
1. How do I receive a username and password for the Billing Matrix?
You must complete an online training course prior to being given access to this system. Please contact Jan Light at firstname.lastname@example.org.
II. Purpose of the Billing Matrix
1. What is the purpose of the 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.
2. What are my responsibilities to the Matrix?
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.
3. I don’t want to do this; do I have to enroll people into the Matrix?
For studies that are deemed to have high billing risk, this is a mandatory requirement from the Washington University School of Medicine administration.
1. Why is the Matrix not listed in the Informed Consent?
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
1. When should I enroll people in a study?
Participants need to be enrolled in a study within one business day after they sign the Informed Consent.
2. When is the End Date?
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.
3. After I enter an End Date into the Matrix for a person, do I then Un-enroll them from the Matrix?
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.
4. I have a study where all the procedures are performed on the same day. How do I enter the dates?
In this instance the Consent Date, the Date of First Clinical Service, and the End Date would be the same date.
5. Are there any studies for which it is not necessary to enter participants?
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 email@example.com.The Clinical Research Billing Support office makes this decision.
6. I tried to change something on the Matrix and can’t do it, what’s wrong?
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 firstname.lastname@example.org. We will discuss it and if needed, we can make the change.
7. I have been asked to retrieve participant information on a closed study. This addresses the billing needs, but would I be HRPO non-compliant by looking at study data when the study is IRB closed?
No. This is not a HRPO/research violation as providing this information is a necessary University function.
8. We don’t currently have IRB approval to collect SSN numbers and it is my experience that many healthy volunteers for studies won’t want to provide their SSN numbers. Is SSN is required?
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
9. What does “engaged” member of the study team mean?
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.
10. Why are you asking for the budget?
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
Clinical Research Billing Analyst
Billing Matrix Secretary
Assistant Dean Clinical Studies
Associate Vice Chancellor