Clinical Research Billing Guidance (CRB)

FAQs – Find answers to CRAO’s most commonly asked questions here.

For assistance in pricing outpatient-care items to build your initial budget or proposal, please contact the Calendar Review & Analysis Office (CRAO) by emailing the specifics of your request to: [email protected].

Email requests should follow this format:

• Email subject should be “Grant Pricing Request: PI-include Grant or protocol ID (If available)”
• CC your CTSU contact (If known) on the email request to keep them in the loop
• Email should include current contact information for yourself and/or a team member knowledgeable about the project and available to respond to questions that come up during the pricing process
• Be sure to include any applicable protocol or other documentation. CRAO will provide a list of Chargemaster prices for requested/protocol-driven items and services to facilitate the creation of a true-cost budget
• Please mark the email “High Importance”

Medicare should not be billed for anything that is not “reasonable and necessary.” While “reasonable and necessary” is a term that Medicare uses to determine coverage, commercial health plans will often use the term “medically necessary.” Each health plan will have a definition of what constitutes a medically necessary service that is covered by the health plan. Experimental and investigational items and services are generally excluded from the definition of “reasonable and necessary” and “medically necessary.”

While you may draw some general conclusions about health plan coverage by looking at Blue Cross Blue Shield coverage guidelines and Medicare guidelines, remember that each health plan is unique. If the possibility exists that health plans will deny coverage, you should establish a prior authorization process to determine if the services will be paid by health plans. If services will not be covered by insurance, your patient/study participants should be advised of that fact. If health plans will not cover the services, your budget should include funding from the research sponsor or another funding source to pay for the services. Keep in mind that billing must be uniform across your study. If the sponsor is paying for a service for one participant, it must pay for all participants. If health plans are to be billed, they must be billed for all participants. The study cannot plan to pay for services only if a participant’s insurance denies the charges.

Items and services provided solely for data collection or screening are generally excluded from the definition of reasonable and necessary. Items and services billed to any payer (commercial or governmental) should be those that are routinely provided to patients who are not participants in a research study. If a research study requires specific items and services to be completed at a greater frequency for study participants than required for non‐participants, those items and services may not be considered reasonable and necessary and may not be covered by health plans.

For additional coverage guidance for governmental and commercial health plans, see the relevant FAQ “Who can provide me with guidance regarding what is covered by Medicare and other commercial health plans?” CRAO FAQs

All clinical research studies initiated after 11/1/06 that involve items and services that are potentially billable through the Michigan Medicine system are required to have a billing calendar, also known as an OnCore grid. Following billing calendar review and approval, the Revenue Cycle Research Billing Team (RCRBs) will use the final billing calendar from OnCore to route charges appropriately.  The principal investigator (PI) is responsible for ensuring that accurate billing is occurring for his or her study and that the approved billing calendar is being followed by the study team. If the PI determines that changes need to be made to the billing calendar after the billing calendar has been approved, a grid modification is required.

If your study has billable items and services, the first step to billing calendar creation is to submit a CTSU intake form, which can be found on the Clinical Trials Support Office (CTSO) webpage. As the study progresses through CTSU startup, CRAO is alerted to begin the calendar build.

Medicare has specific policies associated with clinical research billing. These policies cover investigational device research as well as all other types of clinical research.

Investigational Devices (IDE and non-significant risk)

Medicare should not be billed for ANY items or services associated with an investigational device (IDE) study without prior approval from the Centers for Medicare & Medicaid Services (CMS). If additional information is needed regarding this, see the relevant guidance document.

In general, Medicare covers the routine care costs of qualifying clinical research studies as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in a qualifying clinical trial.

Medicare has established “qualifying” criteria for assessing what items and services are covered in a clinical research study. The “qualifying” criteria are as follows:

1. The subject or purpose of the trial must be the evaluation of an item or service that falls within a Medicare benefit category (e.g., physicians’ service, durable medical equipment, diagnostic test) and is not statutorily excluded from coverage (e.g., cosmetic surgery, hearing aids).
2. The trial must not be designed exclusively to test toxicity or disease pathophysiology. It must have therapeutic intent.
3. Trials of therapeutic interventions must enroll patients with diagnosed disease rather than healthy volunteers. Trials of diagnostic interventions may enroll healthy patients in order to have a proper control group.

The three requirements above are insufficient by themselves to qualify a clinical trial for Medicare coverage of routine costs. Clinical trials also should have the following desirable characteristics; however, some trials, as described below, are presumed to meet these characteristics and are automatically qualified to receive Medicare coverage:

The 7 Desirable Characteristics

1. The principal purpose of the trial is to test whether the intervention potentially improves the participants’ health outcomes;
2. The trial is well-supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use;
3. The trial does not unjustifiably duplicate existing studies;
4. The trial design is appropriate to answer the research question being asked in the trial;
5. The trial is sponsored by a credible organization or individual capable of executing the proposed trial successfully;
6. The trial is in compliance with Federal regulations relating to the protection of human subjects; and
7. All aspects of the trial are conducted according to the appropriate standards of scientific integrity.

Some studies have been deemed by CMS (the Centers for Medicare and Medicaid Services) to meet these characteristics.

• Funded by NIH, CDC, AHRQ, CMS, DOD, or the VA, or
• Supported by centers or cooperative groups that are funded by NIH, CDC, AHRQ, CMS, DOD, or the VA, or
• Conducted under an IND or drug trials that are exempt from having an IND, or
• Reviewed and approved by the Rogel Cancer Center Protocol Review Committee (PRC)

CRAO will conduct a Medicare Coverage Analysis on every study submitted for a calendar build. For those studies that meet the qualifying criteria, Medicare can be billed for reasonable and necessary services, along with certain routine costs. Routine costs are defined as all items and services that are otherwise generally available to Medicare patients and could be found in a medical record for patients outside of a clinical trial.

• Items and services typically provided outside of a clinical trial as standard of care.
• Items or services required solely for the provision of the investigational item or service (e.g., administration of an investigational chemotherapeutic agent), the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications.
• Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service‐‐in particular, for the diagnosis or treatment of complications.

• The investigational item or service, itself, unless otherwise covered outside of the clinical trial.
• Items and services provided solely to satisfy data collection and analysis needs that are not used in the direct clinical management of the patient. This includes any additional tests that would not typically be provided except for the research data collection needs.
• Items and services customarily provided by the research sponsors free of charge for any enrollee in the trial.
• If the study does not meet the qualifying criteria, Medicare should only be billed for those items/services that are reasonable and necessary for the care of the patient and would otherwise have been provided and covered outside the research study.

Other third‐party payers have varying policies associated with clinical research. Some third-party payers follow Medicare policies, and others may not pay for any items and services provided in the context of a research study, even if the items and services provided are considered routine care by the study team and the patient would get the same items and services if they were not taking part in the research. The only way to know with certainty what is or is not covered for a particular subject is through pre-authorization with the subject’s insurance company. Please contact the Professional Billing Accounts Receivable Directors with any questions about insurance pre-authorization.

Work Guide – See directions on how to use the charge routing template and configuration TXT file for bulk load of clinical research billing issues in JIRA.

CRBI JIRA Instructions

Charge Routing Template – Download the template; add data related to clinical research billing issues for import into JIRA for ticket submission. Instructions on how to fill out this template are found on the front page of the template.

Configuration TXT file – Download this file to be used when importing clinical research billing issues using the bulk load function of JIRA.

If you require corrections to your research account or subject, please obtain CRBI JIRA access by contacting [email protected].

For questions/concerns please email [email protected] with subject line CRBI/RCRB help.

The Calendar Review and Analysis Office (CRAO) is the central contact point for clinical research billing error notifications received from your subjects or as a result of your monthly account reconciliation.

The CRAO has immediate access to documents associated with your approved billing calendars (i.e., protocol, final billing calendar, informed consent, etc.) and therefore will be able to investigate and contact the Revenue Cycle Research Billing Team to ensure billing errors are corrected timely.

To report billing corrections, please refer to Clinical Research Billing Correction Load Into CRBI JIRA.

Contact [email protected] with any questions.

OnCore billing calendars mirror a protocol’s schedule of activities, and the underlying logic within a grid is based on visits occurring at specified timepoints. Studies often have conditional procedures or visits that vary from participant to participant and thus cannot be scheduled. To facilitate charge routing in these situations, study teams will complete Unscheduled Occurrence forms in MiChart to alert the RCRBs of these charges.

For more information, view the Tip Sheet: “InBasket – Unscheduled Occurrence.”

Study teams will also log Additional Visits or Additional Procedures in the OnCore system, which communicates unscheduled activity to staff who do not use MiChart. For more information, view the CTSO Work Guide: “Entering Unscheduled Subject Visits.”

Creating a full cost budget is an important step to take before reviewing a sponsor budget so that an appropriate assessment of the sponsor budget can be made. The full cost budget helps evaluate the feasibility of completing the research and allows the researcher and department administrator to know how much money is needed before negotiating with a sponsor or making funding requests. Budgets built in OnCore access fee schedules inclusive of research discount rates. When selecting items and services for your study, it is important to use appropriate billing codes. Billing codes must never be selected based on the available dollars (i.e., “backing into” a sponsor budget). For additional information regarding creating budgets, contact your department research administrator or Grant Services & Analysis in the Medical School.

Money provided by a sponsor to pay for patient‐specific billable items and services must be used to cover these services and should not be reallocated to cover study team effort. You must read the clinical trial agreement and review the sponsor’s budget incorporated in that agreement to determine how the sponsor wants the funds spent. Do not assume that the sponsor is providing money for any purpose. Many sponsors will specifically indicate how funds must be spent. If the sponsor has agreed to pay for certain items or services or provides items/supplies for free, do not bill a health plan or the patient for those items/supplies or services.

Medicare generally covers reasonable and necessary items and services used to diagnose and treat complications arising from participation in qualifying clinical trials. Medicare Secondary Payer regulations, however, have been interpreted by Medicare to prevent the Medicare program from covering services related to these complications when another party has assumed responsibility for payment. When an industry sponsor agrees to pay for subject injury, for example, Medicare views the sponsor as the primary payer for these costs, and Medicare should not be billed. Most commercial health plans will not cover items and services that are the responsibility of another party, often called “third party” or “other party” payment exclusions. The sponsor cannot condition a promise to pay on the denial of claims submitted to a participant’s insurance.

It is the responsibility of the study team to ensure that sponsors are billed for the costs of subject injury in accordance with the clinical trial agreement.

A health plan and/or the patient should not be billed for any item or service that the informed consent says will be provided free or at no charge. The language in the informed consent signed by the patient should be followed even if the language in the consent conflicts with the study protocol and research sponsor agreement since, once signed by the subject, it becomes a legal document. It is the responsibility of the principal investigator to make sure the protocol, clinical trial agreement, and informed consent are all consistent.

During ancillary review in eResearch, CRAO will review consents for appropriate subject injury and cost language. If edits are needed, CRAO will post a communication in eResearch. The consent templates provided by IRBMED contain University of Michigan standard language and instructions on which language should be used based on sponsor and protocol type. If you have questions about which language to include in your consent, please contact CRAO at [email protected].

As a researcher, you should ensure that the money being provided by a sponsor is appropriate and reasonable for the work and services required to conduct the research. Compensation in excess of this “fair market value” may be construed as “kickback” under certain federal and state laws and statutes if one purpose is to generate business between the parties.