Request for Services Instructions
WHY IS ANOTHER REVIEW NEEDED?
When a clinical trial or research study uses Outpatient clinic or Hospital facilities or services, the Research Administration Office of UI Health performs a thorough financial review. UI Health reviews three aspects of the study:
- Procedure pricing to ensure enough money is budgeted for services and supplies offered under the clinical trial or research study at any discounted rate and to ensure that any discounted prices remain Medicare compliant (i.e., are not priced below UI Health’s Medicare rate).
- Review of final clinical trial agreement, sponsor budget and informed consent form to verify that any changes recommended by the Coverage Analysis have been implemented.
- UI Health verification that all necessary clinic and hospital regulatory issues are addressed that might impact patient safety, including infection control, patient privacy, security, or other.
What If I’m Not Using the Hospital?
The Research Administration Office of UI Health reviews budgets for any clinical trials or research studies taking place on UI Health facilities. A short list of some of the clinics would include:
- Arthritis & Kidney Clinic
- Center for Women’s Health
- Child & Youth Center
- Craniofacial Center
- Dermatology Clinic
- Gastroenterology & Liver Clinic
- Heart Center
- Hematology & Oncology Clinic
- Internal Medicine Clinic
- Lung Health Clinic
- NeuroSciences Center
- Nutrition & Wellness Center
- Ophthalmology Center
- Orthopedic Clinic
- Otolaryngology Clinic
- Primary Care Plus Clinic
- Psychiatry Clinic
- Sickle Cell
- Surgery Center
- Transplant Center
- Urology Clinic
WHEN DO I SUBMIT INFORMATION?
You can submit the UI Health Clinical Services Budget Review Form at one of two time points:
- When requesting a signature on your PAF.
- Earlier, when planning your budget. If you’re seeking a preliminary budget review or budget planning/pricing help, submit the form with as many supporting documents as you currently have (i.e., protocol, budget, informed consent and Coverage Analysis).
WHAT INFORMATION DO I SUBMIT?
UI Health will need to review the protocol, Coverage Analysis (clinical trials only), informed consent, budget and contract. Please include these documents with your submission. Also submit the Use of UI Health Hospital or Clinic Services Form.
WHERE DO I SUBMIT?
Requests and documents should be submitted to Scott Kennedy, Director of Research Administration, UI Health. Emailed copies are preferred, sent to email@example.com. Please email with questions regarding the UI Health budget review process.
Request for Services Forms
Research Services Billing
Billing for clinical trial research services and procedures currently involves the following steps:
- Registering in Patient Accounts and signing the Memorandum of Understanding
- Linking patients to the Grant Account
- Putting patients on bill hold
- Providing updates to Scott Kennedy (firstname.lastname@example.org), Director of Research Administion when new patients are enrolled so they can be added to the bill hold
- Documenting Research Visits in the Medical Record
- Removing patients from Bill Hold
- Paying for charges billed to the Grant Account
REGISTERING IN PATIENT ACCOUNTS AND SIGNING THE MEMORANDUM OF UNDERSTANDING
For externally sponsored clinical trials, you must establish a grant account in Patient Accounts once you have been issued a Banner Grant Account number,. Also, at the time of setting up the grant account in Patient Accounts, you will be asked to designate the sponsor as “for-profit,” “non-profit,” or federally funded. This should correspond with what you entered on the PAF.
If the clinical trial is internally sponsored, you should establish a grant account in Patient Accounts once you have received IRB approval.
Fill out the online form in MIDAS. Instructions for this process, and for obtaining a MIDAS account if you do not have one, can be found below.
- Instructions on use of MIDAS for this process can always be found in the UI Health portal under IS Training & Resources/Job Aids
You will also be asked to sign a “Memorandum of Understanding,” which confirms your Department responsibility for paying charges billed to the study’s research account in Patient Accounts.
LINKING PATIENTS TO GRANT ACCOUNT PROCESS
Every “study subject” must be registered in Patient Access even if the subject will not get a bill. The Link Patient to Grant Account Form is used to make certain that charges for study services for the subject are billed correctly. This form assures that the study account is billed, rather than the patient.
PLACING PATIENTS ON BILL HOLD
Currently, due to UI Health’s IT billing systems (Healthquest McKesson for tech fees, WWT EPIC for pro fees), the only way to ensure compliant billing is to put all of a patient’s bills on hold. Charges are then sorted on the back end into three types: charges which bill to the sponsor grant account, charges which are standard of care but related to the study (requiring z00.6, Q1 modifiers, and NCT codes), and charges which are standard of care and unrelated to research. This sorting is done by Research Billing Analysts who apply that study’s Coverage Analysis to the bills and communicate directly with coordinators when questions arise.
Before beginning the bill hold process, please arrange a meeting with Scott Kennedy, Director of Research Administration (email@example.com) to make specific bill hold communication arrangements.
PROVIDING UPDATES ON PATIENTS ON BILL HOLD
Research visits should be tracked, either through a clinical trials management system or at least with a record of essential dates, as shown on the linked spreadsheet. Periodically updating this spreadsheet and forwarding it to Research Administration (firstname.lastname@example.org) can speed up the processing of research bills.
DOCUMENTING RESEARCH VISITS IN THE MEDICAL RECORD
In accordance with CMS policy 69.3 – Medical Records Documentation Requirements research must be documented in the medical record.
CMS 69.3 – Medical Records Documentation Requirements (Rev. 487, Issued: 03-04-05, Effective and Implementation: N/A)
The billing provider must include in the beneficiary’s medical record the following information: trial name, sponsor, and sponsor-assigned protocol number. This information does not need to be submitted with the claim but must be provided if requested for medical review.
Clear documentation in the medical record also increases the accuracy and speed of the processing of research bills.
REMOVING PATIENTS FROM BILL HOLD
When patients go off study or enter follow-up, please notify Scott Kennedy at email@example.com so the bill hold on the patient can be removed as quickly as possible.
PAYING FOR CHARGES BILLED TO THE RESEARCH GRANT ACCOUNT
Departments will receive a monthly statement from Patient Accounts with research charges, and payment is expected within 30 days.