Frequently Asked Questions
What does it mean that my study has MXH funding? How do I enroll my patient in MXH.
New name is Clinical Research Support Fund. Clinical Research Support Fund is a write-off fund that will only allow the investigator to waive hospital billable items required for clinical and translational research, such as laboratory or radiologic tests, hospital bed costs or other hospital-based services. Funds cannot be used for marketing, patient recruitment costs, research supplies or non-hospital testing such as send-out tests. Nebraska Medicine, in partnership with the UNMC College of Medicine and The Center for Clinical & Translational Research has established the Clinical Research Support Fund, a mechanism to support research conducted within Nebraska Medicine on a competitive basis. The intent of this program is to support investigator-initiated clinical and translational research, as well as underfunded federal studies and national cooperative group trials.
How do I view my monthly billing statements for charges billed to my study?
See the link for step-by-step instructions for pulling statements from Epic which supports the charges billed to your study. The statements can be printed or saved as a PDF if needed. They are auto created on the 15th of the month and should be reviewed monthly by research staff. If there is a billing error on a statement, please notify the research billing team within 30 days.
How do I correct the dates on my calendar in CTMS?
If a subject visit occurs outside of the planned date’s tolerance window, the calendar may no longer reflect accurate planned dates for upcoming visits. This guide gives instructions on resetting the Planned Dates on a Subject Calendar. Please see CTMS tipsheet in Service Now.
What do I do if my calendar is wrong?
Be sure to carefully review your preliminary billing grid before you approve it and become familiar with who pays for the services that are part of your protocol. If there is an error in your CTMS billing grid/calendar, please reach out to the lead Clinical Trial Analyst (listed under staff in CTMS).
When do I use Additional (unscheduled) Visit in CTMS
To be used when a subject might require additional unscheduled visits during the study example of additional visit, repeat inconclusive or incomplete tests or procedures from the previous visit.
Do I need to update subject visit information for routine/SOC visits?
Yes, anything included in your protocol, even if routine must be documented in CTMS. All protocol-related encounters and orders must be linked to the study in One Chart to ensure charges are reviewed and routed correctly and prevent billing errors. Visits should be entered into CTMS anytime they are research related to the study. Charges related to research must be linked to research. Once these are linked to research, they will qualify for research billing review in our work queue. We then review the charges against the billing grid/calendar in CTMS and the time points marked and route those charges appropriately. Because this is a Medicare qualifying study, those charges will bill to Medicare with the NCT# and other required identifiers per the NCD 310.1 Medicare guidelines.
When will a Helix subject be charged for a venipuncture?
When a subject has standard of care labs drawn and extra blood is taken for the Genetic Insights Project, labs and collection are billed to insurance. When a Genetic Insights Project blood collection is done by itself, this will route directly to the Helix Genetic Insights account and not to the patient.
Do we collect co-pay for research visits at the time of service?
Co-pays at the time of service are by default collected at the time of service. The patient always has the option to decline payment upfront and receive a bill.
If I need to update the staff list in CTMS, how do I go about this?
Navigate to the protocol in the CTMS: Main Menu>PC Console>[protocol]. Click the Staff tab, then click Update. Select Protocol Staff Role, Staff Name, and enter Staff Start Date as determined by Sponsor (e.g., SIV date, IRB approval date, date of training). Click Add.
Why did my patient receive an estimate?
Patients might receive a Good Faith Estimate prior to study visits when insurance is not set up. These estimates are automated and sent out by Nebraska Medicine regardless of research enrollment.
Does participation in research impact billing for beneficiaries with a Medicare Advantage (MA) Plan, including out-of-pocket expenses?
Medicare instead of the Medicare Advantage Plan is the primary payer for routine costs in a clinical trial that qualifies for coverage under NCD 310.1. Medicare Advantage Plan pays the difference between the amount paid by Medicare and the Medicare Advantage Plan’s in-network cost-sharing for the same category of items and services. The enrollee is then responsible for the standard co-insurance or copayment amounts required by their Plan. The enrollee (or provider) must notify the Plan that the enrollee received a qualified clinical trial service and provide documentation of the cost-sharing incurred, such as a provider bill. (Refer to Medicare Claims Processing Manual Chapter 32 – Billing Requirements for Special Services with & MCM Chapter 4 (cms.gov) (See section 10.7.1, Clinical Trials: Payment of Services w/ links)