Clinical Research Budgeting and Billing Policy
Effective: September 1, 2008
Last Updated: July 16, 2014
Responsible University Officer: AHC Associate Vice President for Research
Policy Owner: AHC Associate Vice President for Research
Policy Contact: Tucker LeBien, PhD, Associate Vice President for Research, AHC
This policy clarifies compliance requirements for the budgeting and billing of clinical services, items, or tests provided to subjects who participate in clinical research, regardless of source of funding. Faculty and staff have a responsibility to ensure that budgeting and billing for costs incurred in the conduct of clinical research occurs only as appropriate and in compliance with relevant laws and regulations. Any billing to Medicare or Medicaid, to another third party insurer, or to the research subject for professional or clinical services, drugs, devices or tests provided in the context of a clinical research project must be allowable by applicable federal and state laws and regulations governing medical billing practices, by other third-party payer requirements; and must be consistent with the study budget and the clinical research consent form signed by the research subject.
As of the effective date of this Policy, each clinical research project will be conducted pursuant to a documented budgeting and billing plan that: 1) delineates the services, drugs, devices, tests, and procedures to be rendered in the context of the clinical research; and 2) states who is responsible for paying for each service, drug, device, test, or procedure.
The protocol for a clinical research project may include standard, conventional treatment for a patient's medical condition. Often, the costs of standard care provided to a patient enrolled in clinical research may be billed to third party insurers. However, when the sponsor of the research provides funding for services/procedures customarily designated as standard care, these costs cannot be billed to Medicare, Medicaid, other third party insurers or the research subject.
There may also be services, items or tests that are purely experimental - not known to be effective or are required for investigational purposes only. As a general rule, costs for items and services that are experimental may not be billed to Medicare, Medicaid, other third party insurers, or the research subject. Costs for services, drugs, devices and tests that are experimental are the responsibility of the sponsor or other entity funding the research (i.e., industry, government agency, non-profit, hospital providers, or departmental funds). Under certain circumstances, as provided in law and regulation, costs for experimental services or items required as part of clinical research may be billed to a third party or to the subject so long as these elements of cost are not reimbursed by the sponsor. It is essential that the Principal Investigator (PI) determine early in the process which cost elements of a trial are standard care and which are research-specific. For each clinical research project, the PI must document the financial responsibility for paying for each service, drug, device, test or procedure.
It is the responsibility of the PI to understand and comply with procedures to meet obligations for billing Medicare, Medicaid and third party insurers for services, drugs, devices, tests and procedures rendered in the clinical research context.
Before initiating an IRB application, the PI (or designee) will enter clinical research information, for each protocol, into the AHC clinical research database. The database will generate a documented billing plan based on the data entered by the PI or designee. The PI or designee will print a copy of the billing plan and attach it to the IRB application. The PI or designee will also include the billing plan with documents submitted to Sponsored Projects Administration.
The PI or designee will complete/update the AHC clinical research database for each person who signs a clinical research consent form, for each clinical research encounter/visit, and for each person who signs a clinical research consent when that person is withdrawn from the clinical research. This information must be entered into the AHC database within seventy-two (72) hours of the event.
It is the responsibility of the PI or designee to maintain records related to the research project and to make such records available for monitoring purposes.
Randy Jacoway, TASCS Information Systems Support Specialist
Tucker LeBien, PhD, Associate Vice President for Research, AHC
For the purpose of this policy, "clinical research" is defined as a systematic investigation, including research development, testing and evaluation involving human subjects, their data, records or tissue and is designed to develop or contribute to generalizable knowledge. The policy does not apply to clinical research meeting the Institutional Review Board (IRB) criteria for exemption (per 45 CFR 46.101).
Enter clinical research information for each protocol into the AHC clinical research database. Print a copy of the billing plan, sign it, and submit it with the initial IRB application and the final SPA Proposal Routing Form (PRF). Update the AHC clinical research database within 72 hours of the following events: each subject/participant who signs an initial consent form, each subject/participant visit that occurs, each subject/participant who ends participation in the clinical research.
Clinical Research Coordinator
If delegated to the Clinical Research Coordinator by the PI: enter clinical research information for each protocol into the AHC clinical research database. Print a copy of the billing plan, obtain PI signature, and submit it with the initial IRB application and the final SPA (PRF). Update the AHC clinical research database within 72 hours of the following events: each subject/participant who signs an initial consent, each subject/participant visit that occurs, each subject participant who ends participation in the clinical research.
Review the PRF for signed billing plan. Assist with purchase order preparation based on billing plan. Monitor start of activity on the account. Charge costs appropriately.
Review and approve PRF. Provide general oversight.
Sponsored Projects Administration (SPA)
Serves as a checkpoint to help assure congruent language and practice in budgeting and billing. Reviews the contract language, proposed budget and billing plan to look for uniformity. Notifies PI and requests revisions if discrepancies are identified. Contract or agreements may not be executed until discrepancies are resolved.
Institutional Review Board (IRB)
Serves as a checkpoint to help assure congruent language and practice in the research consent process. Reviews language in the consent form regarding cost to the participant and matches information to the billing plan. Notifies PI when discrepancies are identified. Final IRB approval may not be granted until discrepancies are resolved.
University of Minnesota Physicians and Fairview Health Services, the affiliated billing entities, acknowledge and agree with this policy. Each has a companion policy in support of this document.
Centers for Medicare and Medicaid Services' National Coverage Decision, 2000.
University of Minnesota Physicians:
Fairview Health Services:
Association of Academic Health Centers guidance, "Investing in Clinical Research Compliance", May, 2007.
Effective: September 1, 2008
To obtain a copy of a historical policy, e-mail the U Policy Librarian at firstname.lastname@example.org or call 612-624-4372.