Clinical Research Billing Guidance (CRB)

CRB Resources:

  1. FAQs – Find answers to the most commonly asked questions here.
  2. CRB Top Ten List (PDF last update 10/15/11)
  3. Research Account Request Form (Formerly 7000 Account Form) (Word last updated 03/22/13) – This is the form you need to request an account to access your research funds for patient specific items/services.
  4. Report 2 Web Research Statement Access Form also known as MiChart Charge Reconciliation Reports request form (Power Point last updated 10/30/15)
  5. How to Reconcile Study Accounts Overview (Power Point added 04/30/15)
  6. How to Reconcile Research Participant Charges using MiChart's Research Study Maintenance (Power Point added 07/28/16)
  7. Clinical Research Billing Policy
  8. CRB Charge Correction Request Form (Excel last updated 01/05/16)
  9. CRB Unscheduled Occurrence Form (Excel last updated 10/04/14)

The Reasonable and Necessary Test 

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 services you are contemplating providing are costly, and 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, your patient/study participants should be advised of that fact. If health plans will not cover the services, your budget should include funding by the research sponsor or by another funding source to pay for the services. 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 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 (24.  Who can provide me with guidance regarding what is covered by Medicare and other commercial health plans? ).

The Billing Calendar

 All clinical research studies initiated after 11/1/06 that involve items and services which are potentially billable through the UMHS system are required to complete a billing calendar within MBECT and submit to the CRAO along with the core study documents. This will be performed automatically when you submit your IRB application, provided questions 7 and 14 of your application are completed correctly. Following the billing calendar review and approval, the Revenue Cycle Research Billing Coordinators (RCRBC) will use the final billing calendar from eResearch Regulatory Management (eRRM) 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, an amendment in eRRM needs to be undertaken which contains the amended billing calendar in section 14‐1.3 and indicates that a CRAO review is needed in the “amendment cover sheet.”

Medicare & Clinical Research Billing

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 or non‐significant risk) study without prior approval from the local Medicare Administrative Contractor for Medicare Part A and Part B. If additional information is needed regarding this, see the relevant guidance document.

All Other Types of Clinical Research

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:

  • The subject or purpose of the trial is the evaluation of an item or service that falls within a Medicare benefit category and is not specifically excluded from Medicare coverage, such as cosmetic surgery..
  • The trial has therapeutic intent (the study is not designed exclusively to test toxicity or disease pathophysiology).
  • The trial must enroll patients with a diagnosed disease (trials of diagnostic interventions may enroll healthy patients as “controls”).
  • The trial must meet the seven (7) desirable characteristics. (Please see below for a description of the characteristics.) Some studies have been deemed by CMS (the Centers for Medicare and Medicaid Services) to meet these characteristics.

"Deemed" Clinical Trials are those studies that meet one of the following characteristics. They are:

  • 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 drugs trials that are exempt from having an IND. or
  • Reviewed and approved by the UMHS Peer Review Committee (PRC)

The study team will determine whether or not a given study meets the Medicare qualifying criteria when it completes the billing calendar in MBECT and the CRAO Analyst will validate this determination by reviewing documents and supporting information obtained via eRRM. 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 in a medical record for patients outside of a clinical trial. For assistance with this process, please contact your designated CRAO analyst.

Routine Costs Include:  

  • Items and services typically provided outside of a clinical trial.
  • 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.

Routine costs do not include:

  • 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.

Medicare 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.
  7. All aspects of the trial are conducted according to the appropriate standards of scientific integrity.

Researchers should ensure that their clinical research studies are designed to be consistent with these characteristics if they would like to be running a “qualifying” clinical trial by CMS’s criteria.

Other Third-Party Payers & Clinical Research Billing 

Other third‐party payers have varying policies associated with clinical research. Some thirdparty 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/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 preauthorization with the subject’s insurance company. Your contacts for insurance plan coverage are the Professional Billing Accounts Receivable Directors.

Research Account Reconciliation  

The study team is responsible for reconciling research accounts at least monthly to ensure that charges have been appropriately allocated to the account. This reconciliation process must include identifying items and services that should have been charged to the research account. Missing items should be identified and if they were billed incorrectly, the money needs to be re‐paid and the correct account charged. This includes re‐paying the patient for any copayments or deductibles the patient may have paid as a result of a bill incorrectly sent to a health plan. The CRAO Coding and Audit Analysts are your primary contact for assistance with clinical research billing issues. You may contact them via email:  CRBIssues-Help@med.umich.edu

Clinical Research Billing Contact Information:  

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 Revenue Cycle Research Billing to ensure billing errors are corrected timely. You will receive notification from the CRAO when your issue has been corrected.

Please complete this sheet CRB Charge Correction Request Form and submit to: CRBissues-help@med.umich.edu. Please call 998-6880 with any questions..

 Unscheduled Research Visit
The CRB Unscheduled Occurrence Form is to be used for any unscheduled/unplanned visits related to a patient in a clinical research study. These charges are for patients who have/had unanticipated services as a result of study activity such as a drug or procedure reaction and are more than likely NOT on the Billing Calendar.

The submission of this form within 72 hours on either side of the unscheduled visit should allow the charges to route to the appropriate payer before charges are billed.We anticipate that in most cases you will request the study be billed for these type of charges. However, if there are circumstances when the patient/insurance should be billed then you would select “Other” in the “Request Being Made” column and add an explanation in the “Additional notes” column. If you are reporting a same day signing of the Informed Consent Form (ICF) and a service provided this must be sent on that specific day in order for the process to work appropriately.

The completed form and all inquiries should be directed to CRBIssues-help@med.umich.edu  (Updated 09/28/12)

Creating a Research Budget
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 will help with the assessment of 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 are created with the use of MBECT with preloaded fee schedules already set at the 80% research discounted rate. 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 the Medical School Grant Review and Analysis Office.

Sponsor Payments & Provided Items
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 clinical trials 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. 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.

It is the responsibility of the study team to ensure that sponsors are billed for adverse events and/or complications for industry‐sponsored clinical trials. For one‐on‐one counseling on completing the subject injury sections of your consent, contact The CRAO Dept. at 734-998-6880.

The Informed Consent Document
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. Also, there are two types of “trigger” language that CRAO is looking for in the consent as an attempt to protect UMHS from negative financial consequences. These items are:

  1. Medicare Secondary Payer (MSP) language
  2. Medicare is the last payer by choice
  3. Inappropriate or lack of subject injury language

For more information on each of these types of language, please contact CRAO at CR2-ao@med.umich.edu.

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