To ensure a patient participant’s insurance is not billed for research-paid services, as well as to make sure all applicable billing compliance rules are followed, OCRICC expects that research teams follow the instructions provided within the Froedtert Health OCRICC Administrative Approval Letter.
We also have several guidance documents that provide additional assistance related to the process.
- Research Pricing Guidance
- Operational Feasibility Determination Guidance
- Medicare Coverage Analysis Guidance
- Informed Consent Guidance
- OCRICC 101 Guidance for Research Teams
- OCRICC 101 Guidance for Froedtert Health Leaders
- Research Paid Services and Preauthorization Guidance
- Community Locations and Service Availability — Feasibility Planning Tool for Research Teams
The Principal Investigator is ultimately responsible for the conduct of their research.
Consent Conversation
It is the research team’s responsibility to have a thorough verbal informed consent discussion that includes a detailed discussion about out-of-pocket costs to the participant. In order to make sure that participants understand their out-of-pocket expenses and what may or may not be covered by their insurance, research teams should encourage patients to check with their insurer for details. Uninsured participants should be informed that they are responsible for all costs not provided free by the study.
Timely Subject Status Updates and Providing a Copy of Signed Consent to Froedtert Health OCRICC
FH OCRICC requires timely subject status updates in either OnCore or EPIC, as well as timely consent notification to trigger the regulatory and operational processes necessary for research participant claims management. This includes invoicing needs and/or routine care claims modification needs based on the agreed-upon financial plan (MCA/SIG/OnCore Billing Grid).
FH OCRICC instructs that, within 24 hours of enrollment, Research Staff must:
- Update their subject status either via OnCore or manual entry in EPIC. Subject status must be updated to ensure compliant billing & invoicing for your study subject. Missed associations will result in escalation as this is a critical area for documentation compliance.
- E-mail a PDF copy of the signed research informed consent form to the OCRICC program e-mail [email protected]. Research staff must place the patient name and MRN (handwritten, typed or a cadence label) on the bottom of every page. If the forms are two sided, this labeling must be on each page. Incomplete or inaccurate consent forms cannot be accepted and will be returned to the research staff to rectify.
This is the process required by Froedtert Health to prevent claims from being billed incorrectly. More information about Clinical Research Billing Compliance can be found here.
Scheduling Research-Paid Services for Commercial-Insured Participants
Research Staff must inform the appropriate FH Preauthorization Teams when scheduling research-paid inpatient stays and/or outpatient services (i.e. procedures or imaging). Communicating when the service is paid by research will prevent unnecessary preauthorization activities. Action will keep your commercial insured patient/participants from experiencing inaccurate denials.
Options for Communication
- Option 1 (BEST): Add statement directly to Order Comments
Recommend using the following scripting: “The XX (i.e. CT scan, colonoscopy, Inpatient Stay) scheduled for XX/XX/XX for PATIENT NAME, MRN requires no preauthorization – it is paid by the research and OCRICC will pull the charges and invoice the study.” - Option 2: You didn’t place the order? Ask the person who originally placed the order add statement directly to Order Comments within 48 hours of placing the order. Use above recommended scripting.
- Option 3: Within 48 hours of placing the order, contact the Preauthorization Team directly via EPIC InBasket message based on the service being ordered. Contact information can be found here.
Notifying OCRICC of Services Performed
Notification to OCRICC is required as outlined in the projects Froedtert Health Administrative Approval. Typically, for services being carried out per the agreed-upon financial plan (MCA/SIG), no separate notification is required unless otherwise instructed in the project-specific Administrative Approval. E-mail notification to the [email protected] is always required when services are either not performed according to the agreed-upon plan or repeated/performed for a particular subject solely for research purposes. Notification must be sent to OCRICC within 24 hours.
**New July 2023: For projects using OnCore Financials, Researchers must also occur the “Additional Visit” in the OnCore Subject Calendar as part of new OnCore Financials research billing notification processes.
Documenting Activities and Services in EPIC
Any activities/services that are considered care and treatment as part of the research project, and/or anything that impacts the care and treatment of the patient participant, or is important for the patient participant’s provider to know, should be documented in the legal health record. As of Oct. 21, 2020, research-related orders and encounters should be linked to the study in EPIC. Any questions should be directed to the assigned OCRICC Consultant on your project.
