Frequently Asked Questions (FAQ)

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

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.

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).

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.

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

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.

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.

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.

CRAO approval is necessary in order for the IRB to issue approval. Enrollment cannot begin without the approvals.

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.

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.

For studies that require COVID-19 testing, this activity will be represented on the OnCore Billing Grid in accordance with the Calendar Review & Analysis Office’s (CRAO) standard guidance that the specification should mirror the protocol. To address charge routing for COVID-19 testing activity that is not represented on an OnCore Billing Grid, submit an Unscheduled Occurrence in the MiChart In Basket.