Research Adjustment- Clinical Research

Implementation Date: 03/19/2009

Date of Last Revision: 05/11/2022

Next Review Due: 05/10/2024

Reviewed by VTH Administrative Team: 01/08/2019

Reviewed by VTH Board: N/A

Reviewed by Legal Counsel: N/A

Reviewed by VTH Section Heads: 03/19/2009

Subject to modification by the VTH Director without approval.

Policy

All animals present in the Veterinary Teaching Hospital (VTH) as part of clinical research must be registered in the Health Information System (HIS).

VTH procedures and supply charges added to a patient’s bill as part of a research project/investigational study will be adjusted off to the appropriate internal account (research grant, contract or startup funds). The VTH will not subsidize research and will not be charged for expenses related to research.

All research performed that involves client-owned animals must have an Owner Consent form approved. Each owner must sign the consent form prior to their animal being included in the study.

Internal University accounts (not client accounts), including research accounts, are eligible for a fee schedule that reflects a discount from client pricing for VTH services performed as part of clinical research. Procedures and charges that are specific to the research are eligible for an 80% discount from client pricing.

Procedures and charges that are specific to the research AND that involve services that support hospital-wide activity (e.g. anesthesia, I.C.U., imaging, etc.) are NOT eligible for an 80% discount from client pricing unless the service provider is a co-investigator AND the service provider is providing the service outside of clinic duties AND the service being provided does not interfere with hospital/service operations.

Materials and supplies removed from VTH ward stock will not receive an 80% discount from client pricing. Research materials and supplies should be procured by the Project Investigator (PI) from the storeroom or pharmacy directly, thereby receiving those items directly charged to the research account. A 5% markup on cost is provided on storeroom supplies and pharmaceuticals charged directly to the research account.

Procedures utilizing clinical services and personnel during normal VTH operations are eligible for a 20% discount from client pricing when those charges are adjusted off the client account and onto the research account.

Reducing or closing a clinical service to accommodate research is NOT allowed. Using VTH resources, including staff, to support research is not allowed. Minor exceptions include those activities that occur during routine patient care that also pertain to research. If the need for VTH resources, including staff, is significant or requires additional compensation of staff (i.e. overtime pay), the research account will be charged.

The VTH does not provide discounts for Veterinary Diagnostic Lab (VDL) or referral lab services. Research adjustments for VDL services must be coordinated directly with that unit and fees associated with those services will not be entered into the HIS. Procedures performed on University owned animals (DAR, teaching, etc.) that are not related to research will be discounted 20% from client pricing for VTH services (VTH Policy #Bill306b) The VTH Director’s office must be notified prior to the initiation of, and after the conclusion of, any clinical trial or research being performed in the VTH. Additionally, an approved Owner Consent form for research involving Client Owned animals must be on file in the Director’s office. The VTH Director or designee will approve the requested discounted fee schedule in consultation with the project PI. Changes to project Research Adjustment – Clinical Research Category: Billing VTH Policy # Bill306a scope, with regards to VTH services, must be communicated to the VTH Director’s Office before implementation. These changes must be reflected in an updated Owner Consent form.  

Guidelines

Appropriate regulatory approval(s) (e.g. IACUC, IRB) is required prior to the start of any clinical trial or research.

All animals must be registered while in the VTH.

When a project involves privately owned animals (non-University owned), an Owner Consent form is required. All procedures and services associated with the research must be fully documented in the Owner Consent form signed by the client. The consent documents the client’s financial responsibility as well as those procedures to be paid for by the research funds. Consent must be submitted for review to the VTH Director or designee prior to the initiation of any study where hospital patients are involved. The review will include documentation of compensation to the client and compliance with the appropriate University required language for informed consent. A copy of the approved consent form will be on file in the VTH Director’s Office.

Research fees will be based on current client pricing for professional services. When initiating a research project involving VTH services, charge codes for the professional services and procedures that will be used during the research must exist in the Health Information System (HIS). New codes must be created for procedures not already in the HIS. All charges will be entered routinely in the HIS for the patient’s visit. Prior to patient discharge, a research adjustment must be applied to transfer the charges from the client’s account to the research account. The amount charged to the research account will reflect the appropriate discounts as previously outlined. Fees that are eligible for the 80% research discount will not be discounted further (e.g. working dog discount, employee discount).

The 80% research discount is NOT applicable to imaging modalities when an official imaging report from an individual or source not involved in the study is required.

Research discounts are only applicable when the associated charges are being paid for by accounts held internal to the University (e.g. research accounts). Clients are expected to pay the standard price of procedures not covered by research funding. A new patient fee will be charged unless the patient is preregistered with the VTH.

Storeroom and pharmacy items used for research will reflect a markup of 5% based on acquisition cost when acquired for project use by the PI. The research fund account information will be required at the time of purchase and the researcher will be responsible for the purchased items. Items purchased directly with research funds, and not entered into a patient’s record, do not require that charge codes or an adjustment be made. Research-related charges for pharmacy and storeroom purchases that are entered into a patient’s record and transferred to research funds must have charge codes created, and subsequent adjustments made, as above.

All clinical non-research cases will take priority when utilizing hospital equipment, personnel, and services.

Procedure – Privately Owned Animals

1. Submit Proposal/Grant.
2. Initiate IACUC Approval Process: http://research.illinois.edu/regulatory-compliance-safety/animalcare-and-use/animal-use-protocol-process
3. Create Owner Consent.
   1. Select Veterinary Teaching Hospital form ‘Consent Form for Research or Clinical Trial’ (https://vetmed.illinois.edu/intranet/vth/forms.html).
   2. The form includes the project name, name of PI, description of the project scope, and financial responsibility attributed to the owner.
4. Submit Owner Consent Form to VTH Director (VTHDirector@vetmed.illinois.edu) for approval.
5. Consult with VTH Director, or designee, to determine the eligibility of fees for discount. VTH Director’s Office will provide details of approved fees to VTH Business Office.
6. Notify the VTH Director’s Office that a clinical trial/research project involving VTH services has been initiated.
7. Submit the Approved Owner Consent form to the Health Information Systems (HIS).
   1. Submit account creation request to HIS team (VetStar-Help@vetmed.illinois.edu).
   2. HIS team will create the research account.
   3. HIS submits research account information (FOP) to VTH Business office.
8. ALL client-owned animals MUST be registered when in the VTH.
   1. New patient fees will be waived if the patient is preregistered.
9. Initiate research and ensure the client has signed the approved Owner Consent Form.
   1. Investigators are responsible for maintaining signed consent forms for their studies.
10. Perform research and enter charges into the patient record.
    1. All procedures will be recorded in the HIS.
11. Submit an electronic research adjustment form prior to patient discharge.
    1. The adjustment should reflect all charges that are being paid for by the research account and should equal the amount being adjusted off of the client’s bill.
    2. The client will be expected to pay for non-research-related charges and payment will be due at the time of patient discharge.
12. Adjustments to the client account will occur and the research account is reconciled.
    1. The VTH Business must be notified when the account is needing to be reconciled. This must be done within 60 days of the adjustment being processed on the client account.
    2. The VTH Business Office will apply the research discount to the eligible charges that have been transferred to the research account.
13. Notify VTH Director’s Office upon the conclusion of the project

Procedure – University Owned Animals

1. 1. Submit Proposal/Grant.
2. Initiate IACUC Approval Process http://research.illinois.edu/regulatory-compliance-safety/animalcare-and-use/animal-use-protocol-process.
3. Consult with VTH Director, or designee, to determine the eligibility of fees for discount. VTH Director’s Office will provide details of approved fees to VTH Business Office.
4. Notify the VTH Director’s Office that a clinical trial/research project involving VTH services has been initiated (VTHDirector@vetmed.illinois.edu).
5. Submit detailed information regarding the VTH services to be used to the Health Information Systems (HIS)
   1. Submit account creation request to HIS team (VetStar-Help@vetmed.illinois.edu)
   2. HIS team will create the research account and create new procedures with research pricing identified
   3. HIS submits research account information (FOP) to VTH Business office
6. ALL University owned animals MUST be registered when in the VTH
   1. New patient fees will be waived if the patient is preregistered
7. Initiate research
8. Perform research and enter charges into the patient record
   1. All procedures will be recorded in the HIS
9. Charges will be paid for through the research account at the time of patient discharge

Notify VTH Director’s Office upon the conclusion of the project

Definitions (if applicable)

Clinical research – Any research utilizing equipment or services that are part of the Veterinary Teaching Hospital and being conducted by College of Veterinary Medicine faculty.

VTH – The collective clinical services of the Large Animal Clinic, the Small Animal Clinic, and the Veterinary
Medicine South Clinic.