Faculty and Staff initiating clinical research submit protocols for review to the Clinical Trials Support Unit (CTSU) for a feasibility review, and if approved by the Medical Director or Operations Manager it will then come to The Calendar Review & Analysis Office (CRAO) for a grid build. This is considered the build process. CRAO will review all of the study-related documents (protocol, informed consent, billing calendar, budgets, grants/contracts) and complete a Medicare Coverage Analysis in addition to a billing grid review in order for CRAO to review and approve.

The core documents will be pulled by CRAO from OnCore and/or eResearch Regulatory Management (eRRM) and Proposal Management (eRPM), as necessary. If the study team answers question 7-1.2 and Section 14 in eRRM in such a way that they exempt themselves from CRAO review, CRAO will be bypassed for review at that time. It is CRAO's policy to run a monthly report of exempt studies and review the correctness of the exemption status. The study team may be asked to complete a billing grid for review if CRAO determines the exemption status is incorrect.

Michigan Medicine at the University of Michigan, which includes the Hospitals and Health Centers, the Faculty Group Practice, and the Medical School, has an ongoing commitment to ensure that its affairs are conducted in compliance with applicable law. Michigan Medicine also has a strong interest in ensuring faculty and staff are informed about applicable laws and regulations so that they do not inadvertently engage in conduct that raises compliance issues.

As an academic medical center, since many of our faculty engage in clinical practice, legal requirements related to professional fee billing and facility billing related to clinical research are of great importance. It is also CRAO's policy to review each study for subject injury language to verify that it aligns with the sponsor’s agreement with Michigan Medicine. The study team may be asked to revise the subject injury language in such a way that the sponsor or Michigan Medicine will be responsible for paying for subject injury due to the study drug or device. Michigan Medicine Clinical Research Position Statement and Template Language are available on the Michigan Medicine Research A-Z website.

It is the policy of Michigan Medicine to bill only for services actually provided and to bill the appropriate payment source. Billing for patients participating in clinical research studies is particularly complex because there are multiple potential payors involved. Services and devices that are paid for by the research sponsor must be billed to the research account. Services and devices that are covered benefits and fall into the category of routine services/standard of care must be billed to the appropriate health plan. Services that are not covered by the health plan or the research sponsor are billed to the patient. In order to make this complex billing situation accurate, your study budget, informed consent documents, research protocols, and billing grid all must be consistent in identifying the appropriate payment source.

The review currently conducted by the CRAO is a quality assurance process that is intended to identify any inconsistencies that may result in submitting an inappropriate claim. The current process is labor intensive, highly manual, and requires your cooperation, communication, and patience in order to assure the process flows smoothly. When there are inconsistencies, CRAO will ask for an explanation and may require you to change some of the documents. The goal of our office is to ensure that any claims submitted to research sponsors, health plans, and patients are accurate and comply with Medicare and other billing guidelines.

Engaging in any research activity prior to CRAO and IRB approval exposes both you and Michigan Medicine to potential compliance concerns about the appropriateness and accuracy of the claims, and can jeopardize the future of your study.

Your cooperation and commitment to compliance are much appreciated. CRAO is continually working closely with other departments within Michigan Medicine to improve the Clinical Research Billing process. Your constructive feedback is essential to improving processes as we continue to implement new technology solutions. If you have questions regarding the applicable law that surrounds these clinical research billing requirements, contact Health System Legal Offices. CRAO staff members are available to meet with you or with your department to review the current billing grid process and we can be reached at [email protected].

Device Study Procedure Flow (06/01/2023)
Dental School Guidelines (06/09/2023)
Michigan Medicine Clinical Research Position Statement on Subject Injury (07/01/2023)