Dear SOM Clinical Research Community,
Please carefully review the announcement shared below from the UNC Office of Clinical Trials and UNC Health.
**UPCOMING CHANGES TO BILLING COVERAGE ANALYSIS and CHARGE REVIEW PROCESSES**
The Office of Clinical Trials and UNC Health announce upcoming changes to the billing coverage analysis and charge review processes effective April 11, 2021.
The process for conducting a Billing Coverage Analysis (BCA) and Epic Research billing review has long been a burden on the research community. To decrease this burden, the Office of Clinical Trials (OCT) and UNC Health have worked together to implement standardized processes.
The OCT will have a team dedicated to preparing and conducting a billing coverage analysis on all clinical trials conducted at UNC-Chapel Hill and UNC Medical Center. UNC Medical Center includes, including all UNC Hospitals’ Chapel Hill facilities and, the clinical patient care programs of the School of Medicine of UNC-Chapel Hill (including, UNC Faculty Physicians and the UNC Hillsborough Campus). Concurrently, UNC Health will ensure alignment of billing review processes for the UNC Health Network Entities. Note: The BCA and research billing review process will remain the same for the UNC Health entities. Both initiatives are meant to help ensure compliant research billing while decreasing administrative burden for research teams.
Please review the full policy on research billing and summary of changes for each the BCA process and Epic Research billing review, listed below:
UNC Policy on Research Billing
BILLING COVERAGE ANALYSIS – Summary of Changes
Beginning April 11, 2021 all NEW clinical research protocols which will be conducted at UNC-CH and/or UNC Medical Center will be evaluated by the Office of Clinical Trials (OCT) and, if applicable undergo a coverage analysis by the OCT Clinical Research Compliance Billing Team. The OCT team will then complete a Billing Coverage Analysis (BCA) for all studies with charges processed through Epic, including the following services:
- Conduct Medicare coverage analysis to determine billing status for any studies with study-related billing to patients
- Create billing grid of services related to the study with research costs and codes
- Reconcile final BCA with consent form and any clinical trial agreements
- Build Epic calendar (for non-Oncology protocols)
- Activate the protocol in Epic
The Billing Team will obtain input from the research team prior to the initial build of the BCA, then meet to present the BCA to the research team and PI. When the study is ready to begin enrolling participants, the Team will meet with the PI and all relevant research team members for a final compliance review and then complete the process by activating the study protocol in Epic.
What does this mean for you?
- All NEW studies MUST be submitted through CRMS as soon as the decision has been made to move forward with the clinical trial. Please create a CRMS record and include the protocol, draft informed consent and any other relevant study documents. We recommend creating the CRMS record sooner rather than later. The OCT Team will review the study to determine the need for a BCA. If it is determined that a BCA is required, the OCT will create the BCA then schedule a time to review with the study team before finalizing.
- Once finalized the study team can use the BCA to complete budget negotiations.
- Submitting a CDA to the Industry Contracting Office will not trigger a BCA to be completed since there is no protocol.
- To obtain costs in preparation for a proposal the OCT will make the UNC Research Fee schedule available in an ONYEN protected environment.
FAQs
Q: How can I request a billing coverage analysis for my study?
A: When you have a study that you know you will be implementing, you will need to create a record in CRMS. If you already have a record because you have submitted a CDA request through CRMS, you should use that same record for your BCA and CTA requests
Q: How do I know if I need a coverage analysis?
A: ALL studies need a “coverage analysis”—a review to determine if any billing related to the study will be processed through Epic. OCT will review all new studies to make this determination. If there is no Epic billing, then OCT will alert the study team and notate in CRMS. If there is Epic billing, OCT will proceed with completion of a BCA billing grid and include Medicare review as needed.
Q: My study will have charges generated in Epic, but the study will cover all costs. Do I still need to submit to OCT for review?
A: Absolutely! ALL studies need to be entered in CRMS and will undergo review by OCT. A Medicare review will not be required if there will be no billing to subjects, but a billing grid is essential in order to inform the Epic calendar build which, along with charge review, helps prevent billing errors.
Q: What do I need to include in the CRMS record?
A: In addition to the PI and study title, at the least you should include the following information:
- In the Protocol section, you should include in the team members contact information for everyone who can answer billing questions about the study.
- You should add the IRB number if you have it, as this will pull all the documents submitted with the IRBIS application into CRMS.
- If there is no IRB yet, then upload the protocol and all other relevant documents, as applicable.
- Consent (draft ot template OK)
- Any Sponsor provided coverage analysis information
- Any Sponsor provided budget or CPT code information
- The Investigator Brochure
- The Instructions For Use, if device
- Any FDA information about IND, or IDE or 510K cleared device
- Any CMS information about CED protocols
- Federal Funding Sheet for cooperative group studies
Q: How will the process work?
A: The OCT BCA Team will review your protocol to determine if there will be any billing associated with the study through Epic. If there will be, then a billing grid will be built and, if there is any billing to participants, a Medicare coverage analysis will be performed. Any items or services billed to patients will include a justification based on NCD 310.1, and a citation for the source of the information. The BCA will be compared to the consent, any contract or grant awards, and the budget. A meeting with the PI and research team will be scheduled to review the BCA and make any revisions. The PI will then sign off on the final BCA in CRMS until OnCore enterprise is implemented. An Epic calendar will be built (non-oncology ones by OCT, oncology ones by Lineberger team). When all study related processes have been finalized, OCT will schedule another meeting with the research team (and PI if available), and OCT will then activate the study in Epic.
Q: How long will it take to get the costs and codes?
A: OCT will complete the BCA in a timely manner, but an exact timeline depends on the complexity of the protocol and the availability of documents needed to complete the analysis. If you urgently need costs for a time-sensitive negotiation with a Sponsor or a grant proposal, please include a Note in CRMS (accessed from the left hand menu under the Protocol tab). OCT will enter the costs in the BCA spreadsheet and you can view them while the BCA is in progress.
Q: What happens if I have already started a BCA for my study?
A: If you have downloaded the BCA template for your study in CRMS before April 11, then that BCA will be completed under the current process. Because functionality in CRMS will be changing with the new process, you will not be able to move the BCA through the system; OCT will contact you and provide a work around. You can email Andrea Eiring, aneiring@email.unc.edu with any questions.
Q: What if I don’t have a protocol yet—I just need some costs to decide if I want to proceed with a grant or IIT?
A: Email OCT at OCT@unc.edu and request access to the research fee schedules. You will be sent a link to an ONYEN protected SharePoint site with the current hospital and professional research fee schedules.
STANDARDIZED RESEARCH BILLING REVIEW – Summary of Changes
Starting on 4/11/2021, UNC and UNC Health will be implementing Standardized Research Billing Review.
What is Standardized Research Billing Review?
Standardized Research Billing Review is a holistic approach to the Research Billing process. This will include comprehensive review of all encounters for a patient active on a research study via a two-tier Research Billing Review process.
- A patient who is tagged as “In Screening,” “Enrolled,” or “Off-Treatment” is considered an active patient.
- All encounters will go through this process and not just the encounters that have been linked to the research study.
Why?
Standardized Billing Review will improve accuracy and compliance with research billing procedures. This new operational process will also reduce administrative burden related to billing review for research teams.
What does this mean for our Research Users?
Research Coordinators will be responsible for the following items to ensure a smooth transition to Standardized Research Billing Review process for all UNC sites:
- Link research encounters to the research study
- Maintain accurate and current Patient Research Study Statuses (aka Enrolled, Completed, etc.)
- Add and maintain Patient Timelines in Epic
- Utilize SmartText for research encounters
- The research study team will still be handling all invoice payments to UNC Health, if applicable to your team.
Please keep an eye out for refresher LMS courses to be pushed out to our Research Community.
FAQs
Q: Won’t reviewing all encounters for an active research patient generate a lot of work?
A: Yes, because all encounters will be going through the Two-Tier Research Billing Review Process, there will be more items to review. However, this will help ensure we are remaining accurate and compliant with Research Billing. The research study team will need to link encounters and add the patient timelines in Epic in order to help expedite this additional volume of review.
Q: Will Chapel Hill research study teams be completing Research Billing Review?
A: No. The research billing review that has historically been completed by the research study team will now be managed centrally.
Q: Who will be completing the Standardized Research Billing Review process for Chapel Hill research study teams?
A: UNC Health Rev Cycle will be completing both tiers of review. But it is important that the research study team to fulfill its responsibilities so that the UNC Health Rev Cycle team can efficiently perform its reviews.
Q: What if there is a discrepancy with a research patient’s bill?
A: Please contact UNC Health Billing Customer Service at 1-800-594-8624 on behalf of the patient or ask the patient to call themselves. A formal review will be performed and corrections will be made if needed.
Q: What if my research study will never generate a charge in Epic?
A: Please reach out to the BCA Coordinator team or the ORSC Finance team (whichever is appropriate for your study team) with your IRB number. They will review the BCA and if it meets the appropriate criteria, a flag can be added to your study in Epic. This flag will allow the patients involved in this study to bypass Research Billing Review.
Q: What will change for the UNC Health Network Entities in the new standardized process?
A: If you are a research coordinator or research biller, you will review all encounters rather than just linked encounters. Research coordinators will also complete the first tier of review.
Q: What if I have additional questions about Standardized Research Billing Review?
A: Please send an e-mail to epicuncresearch@unchealth.unc.edu
The OVCR will be conducting a virtual town hall to be held in mid-April to help answer any questions or concerns
Christine Nelson
Director, Office of Clinical Trials
University of North Carolina at Chapel Hill
720 Martin Luther King Blvd, CB #1651
Chapel Hill, NC 27599-1651
P: 919-843-0832
F: 919-843-2399