Billing Calendar & Study Applications
What are the standard institutional Clinical Research discount rates?
Professional Fee Discount
All professional fee charges will be discounted to the Medicare fee schedule (which equals roughly 70% discounted).
Facility (Hospital/Technical) Fee Discount
- All charges will be discounted by 80% except:
- Inpatient room rates (routine, specialty beds, and ICU) = 50% discount
- Lab reference tests (tests not performed by UM labs, send-outs to reference laboratories) = No discount
- Organ acquisition fees = No discount
Can I just not bill for an item or service because it is a part of a research study?
You cannot “comp” something because it is being done for research. All items or services that are billable outside of a research study in the clinical setting must also be billed within the research study. The difference is that the charge for a study specific item or service will include the institutional research discount rate. However, services provided by research staff in research space are generally not considered billable.
Do I need to do anything special for an Investigational Device Exemption (IDE) study or a Non-Significant Risk (NSR) device? (Updated 01/18/13)
You need to get approval from Medicare for ANY items or services that are a part of an IDE or NSR study and for which you intend to bill Medicare. Please see the provided template letters (update 08/17/12). For an IDE/NSR study, you should contact the CDM and Rate Setting team to determine if a CDM needs to be assigned to the Category B IDE device, or NSR device(s) being used. Please refer to Obtaining a Charge Description Master (CDM) Number (PDF).
Why does my research study need to undergo clinical research calendar review?
A clinical research calendar review helps to ensure that a plan related to billing (which party should be billed for which service) is in place for each study that involves billable items and services. This includes research related or routine care billable services. This plan or billing calendar outlines which items/services are routine care and which are research, so that charges can be routed to the correct payer. Additionally, The Centers for Medicare and Medicaid Services (CMS) requires that a research modifier be applied to routine care items that occur within an approved clinical trial.
How do I initiate the clinical research review?
If it’s a clinical trial or has billable items and services, then the study team will need to reach out to the appropriate CTSU to initiate the process, and once approved, CRAO will be alerted via a daily report. The CRAO is also alerted of studies that meet the criteria for calendar review based on answers in the IRB application. The CRAO can begin its review as soon as the most recent protocol has been uploaded into OnCore. CRAO also requires five core documents (the protocol, informed consent, billing calendar, budget, and contract, if applicable) to be uploaded into either eResearch Proposal Management or eResearch Regulatory Management. The five core documents are the required documents to complete a thorough Medicare Coverage Analysis and review of the study’s billing plan. The core documents can be draft documents
When should I submit my study to the CRAO?
Your CTSU will submit your study to CRAO and within eResearch if you answer section 7-1.2, Will subjects undergo healthcare-related treatments or procedures (standard of care and/or research) as part of the study? as “Yes” then this will prompt section 14 to be completed. Your study will then be routed to the CRAO for review and approval based on questions answered in section 14-1 of the application. If you indicated that your study has items, services, tests, or procedures, occurring anywhere within the University of Michigan, including MCRU, a billing calendar will need to be created by CRAO. Items and services that are listed in the Protocol and Informed Consent and will be billed to subject’s insurance or RMRN account must be included on the calendar. Please note that Quality Assurance (QA) and Quality Initiative (QI) studies do not need a billing calendar. Like other Ancillary committees, CRAO approval will be required, prior to IRB review and approval. Depending on the study, additional documentation may be requested—such as approval of the IND or IDE application by the FDA.
How do I decide what is “routine care” on a billing calendar?
Routine care items and procedures are generally considered to be items or services provided to a similar patient (of a comparable age and health status) at a similar timeframe outside of the trial. One would expect to find this type of item or service in the medical record of a non-study patient with the same disease, diagnosis or condition. Clinical Practice Guidelines are a good source for helping identify those items that would be considered routine care. Ultimately, for our purposes, it is the PI’s certification that an item or procedure is, in fact, routine care. If this is determined not to be routine care, it may result in the denial of insurance coverage.
I know that U-M is applying Medicare policies to all studies. Is there anything I should do regarding other payers/insurance providers?
On behalf of your study subjects, it is recommended that items and services are pre-authorized if they are provided in the context of a clinical research study. The CRAO recommends this approach, particularly for costly items and services which are designated as routine care. Please note that some insurance companies may not pay for items/services provided within the context of a research study. Even if the items/services are considered the standard of care outside of a clinical trial, the fact that they are taking place within a clinical trial may exclude them from coverage.
Can I start enrolling the subjects on my study without having CRAO approval?
CRAO approval is necessary in order for the IRB to issue approval. Enrollment cannot begin without the approvals.
What should I do if changes or amendments are made to the study documents (by the PI, sponsor, IRBMED, ORSP, etc.) after I have already received approval from the CRAO?
Amendments and modification requests are handled within both OnCore and eResearch. If there are any changes to billable services, an amended billing calendar will need to be created by CRAO. The CRAO is primarily concerned with billable services being directed to the appropriate party so we are reviewing the amendment for any changes that may affect the billing calendar and routing of charges.
How should the informed consent for a study correspond with the approved billing calendar?
All of the items and services listed on the billing calendar and in the study protocol should be described in section 4.1 of the informed consent whether or not they are considered to be the investigational item itself. It should be clear in the consent which items are considered standard of care and which are study-specific. All items and services that are associated with the study do not need to be repeated in section 8.1 but it should be made clear in this section that the study-specific and research-specific items/services are being covered by research funds and will not be billed to the subject or his insurance. Please contact CRAO for appropriate subject injury language.
Clinical Research Billing Guidance (CRB)
Should I tell anyone if I have a research subject who is going to be an inpatient?
If the admission is a research admission and all associated charges will be billed to a research account or if the inpatient admission is associated with an Investigational Device Exemption (IDE) or Non-Significant Risk (NSR) study, the manager of the Inpatient Business Office should be notified prior to the admission. The only exception to this is for MCRU admissions. If your patient is being admitted to MCRU, MCRU staff will notify the Inpatient Business Office on your behalf. Please note that the Inpatient Business Office does not need to be notified for clinically indicated admissions that also happen to include some research-related items/services.
When the patient is scheduled for admission, send an email notification to ResearchSubjects@med.umich.edu and include:
- Subject: Research Patient Admission HUM########
- Content: Research Subject MRN#, Admission Date.
Should I try to make sure anything specific is included in the medical record for a research subject?
In order to provide the best clinical care, include relevant clinical information, primarily the HUM number (the number given to the study in eResearch). Also, it is a MM requirement that you upload the signed informed consent document for any research subject into MiChart so that caregivers are fully aware of the patient’s clinical background. The medical record must clearly indicate all items and procedures that are provided that are study-specific. The documentation should match with the billing calendar approved by the CRAO.
What should I do if the CRAO identifies budget and/or clinical trial agreement issues related to my study?
CRAO is reviewing the study documents for Medicare Secondary Payer (MSP) and subject injury language. MSP language is conditional language that can be found in the Informed Consent (generally sections 5.2 and 8.1) and/or Contract. It may say something like “the sponsor will pay for complications if your insurance does not” or “bill insurance first, then sponsor will pay." It is possible that there will be discrepancies between one document and the other. In those cases, CRAO will inform the study team of the discrepancies and the potential risks of proceeding. It is Michigan Medicine Policy to include subject injury language in the Consent if the study includes serious risks. If subject injury language is missing from the Consent or the incorrect language has been added, the study will be assessed by the CRAO Medical Director for the correct subject injury language to include in the Consent. Once a decision in regards to the correct subject injury language is made, CRAO will advise the study team to revise the Consent to meet the recommendations of the CRAO Medical Director. CRAO will notify the respective ORSP representative to address Contract language issues, as well as the IRB so they are aware of the requested language to be put into the Informed Consent. It is our recommendation that the spirit of the contract language be carried over to the Informed Consent.
If my study involves items or services (such as labs) that are going to be analyzed at an off-site central location or non-clinical setting (like an individual researcher’s laboratory), should I indicate this on the billing calendar?
If all the labs are being drawn by MCRU or a member of the study team and sent out for analysis, it is not necessary to list out the individual names of the laboratories to be analyzed (CBCPD, Comp Panel, PK, LFT, etc.). You can choose “Lab-Send-Outs” in MBECT rather than listing them individually. Choose “Mark all as non-billable” and make a comment stating why this is non-billable. If the labs are being drawn at a blood draw station at UMHS, you will still need to add a venipuncture line to the calendar. It is not necessary to note frequency of the labs in the comment section.
Can the charges associated with the treatment of complications from clinical research be billed to a patient’s insurance?
Please contact CRAO for guidance.
Who can provide me with guidance regarding what is covered by Medicare and other commercial health plans?
If you have a specific question about whether or not an individual item or service is covered by a specific insurance plan for a specific patient, contact your Revenue Cycle Pro Fee Billing Contacts for assistance. Keep in mind that coverage can vary greatly from plan to plan. Also, two different patients covered by the same insurance company can have significantly different coverage. Departmental billing directors should be the primary contact for study team members who have these sorts of questions.
Do I need to submit subject enrollment information?
Yes. Please see the following work guide. Enrollment is now entered into OnCore which then moves to MiChart
Who do I need to notify if I have a subject on my study has been billed incorrectly or if incorrect charges are coming through on my study account?
Please visit our how to Bulk Load Charge Reconcile page.
Is there anything I need to do if one of my subjects is coming in for an unexpected visit (complication/AE/SAE)?
The CRB Unscheduled Occurrence Form should be completed and emailed to CRBissuesfirstname.lastname@example.org. This will allow the CRB issues staff to notify Revenue Cycle that the charges associated with this subject(s) unexpected visit should not be routed to the subject. The Unscheduled Occurrence form can also be used for notifying CRB issues of study activity occurring the same day as subject enrollment. When this form is completed and sent to CRBissuesemail@example.com, it allows the CRB issues staff to enter enrollment in MiChart that day and will stop the charges from being incorrectly routed to the subject.
Additional information for Study Teams can be found by reviewing Clinical Trials Support Office Work Guides.