Imaging Sciences (Radiology)

Clinical Trials

Processes and Procedures

Starting a Clinical Trial - We Can Help

The Department of Imaging Sciences can provide you with any variety of radiologic services to meet your clinical trial needs. If your imaging requirements involve only exams that are considered Standard of Care, you may schedule them yourself as per normal routine, using the standard departmental requisition with billing to the patient or third party payer. Imaging Sciences provides services at several locations to best suit you and your patient needs.

If your trial has imaging requirements that are NOT considered Standard of Care, we are available to assist you in determining the specific exams to fit your protocol needs and the budgetary cost information for these. Dedicated exam requisitions are then created specific to your trial to ensure that the required exams are scheduled and billed appropriately.

A successful trial requires compliance with protocol demands – and imaging needs are often very specific. To this end and as you need, we can distribute any protocol mandated imaging requirements to the appropriate radiology personnel. This applies to Standard of Care exams as well. During the course of your trial, we are otherwise available to assist you in troubleshooting any problems or in meeting any changes to the study.

Obtaining a Quote for a New Clinical Trial

For imaging needs that are not Standard of Care, please fill out the Imaging Sciences Clinical Trial Request for Quotation Form, found under the Forms link. Please fax or email the completed form to JoAnne M. McNamara, RN-c, MS, Clinical Trials Coordinator for the Department of Imaging Sciences.

Based on the information you provide, we determine the procedures required to meet your trial needs, the corresponding CPT codes and we will estimate an exam cost discounted according to your funding source. Our fees are based on the CPT code and any associated incidental hospital supply charges. Service needs that arise later, would of course be additionally chargeable.

For trials that you anticipate involving the radiology services of University Medical Imaging, please contact Mike Lechner directly to arrange for this. He is available by e-mail at Michael_Lechner@urmc.rochester.edu or by phone at (585) 341-9100.

Quote Format & Fees

Radiology procedures performed at Strong Memorial Hospital and Clinton Crossings - Orthopedics have two fee components: a technical/hospital component and a Department of Imaging Sciences/professional component. The technical fee is set and billed by the hospital. The Department of Imaging Sciences sets and bills the professional portion. The quote you receive from us will list both components which, when summed, represent the total exam fee.

Please be aware though, that we are only able to estimate the technical component, based on the existing published hospital price schedule and practices. The hospital is not bound by this estimate and can change their fees. Historically, the hospital has had annual increases to the charge schedule by small percentages for cost of business. Keep this in mind when preparing your study budget. Please see our Frequently Asked Questions.

To reflect these fee components, you will be charged from both the Department of Imaging Sciences and the hospital. The hospital will draw payment directly from your ledger for the technical fees.

You will receive a copy of CMS-1500 form (generated from the IDX billing system) from the Department of Imaging Sciences for the professional charge component. The fees will be corrected according to the formal quote you received during study start-up and any additional fees will be added as needed. In turn, your payment is made on a 312 requisition.

For Radiology services provided at University Imaging at Science Park, you will be quoted a discounted global fee, which encompasses both technical and professional components. You will receive only one invoice for these exams from the Department of Imaging Sciences, form CMS-1500 as described above.

Requisitions

Once you are ready to proceed with the trial, please provide us with the ledger number you have been assigned from ORPA. This is needed to charge exams against and to create a trial specific requisition for your use. This requisition has the technical, contact and billing information required for correct registration and patient service. Complete this as you would our standard requisitions, then use the phone and fax numbers provided at the bottom to schedule exams. Please remember to:

  1. Add other ICD-9 codes as may be appropriate to the study or diagnosis. We will routinely list V70.7, which indicates an “examination of a participant in a clinical trial.”
  2. As appropriate, add a narrative description of pertinent patient history, signs and symptoms, which help the radiologist in the interpretation of the exam.
  3. If you have provided us in advance with specific imaging protocols, please reference that on the requisition as well. The more information we have, the better the service we can provide

Image Management

We are an electronically archived department. All studies are acquired digitally and transmitted to a picture archiving and communication system (PACS). If needed, CD copies of your exams can be provided free of charge and can be de-identified as you require. Please contact our Film Library at (585) 275-5368 with your hard copy requests. Film copies are still available if required, but there is a fee of $15.00 per sheet. Again, please contact the Film Library to request these.

Clinical Trials Form

Request for Quote

Frequently Asked Questions

What is the turnaround time for a Clinical Trials Quote?
Depending on the complexity of the quote, we target a turnaround time of no greater than one week. At times, further clarification may be necessary from you or your PI, the sponsor or another physician either inside or outside the Department of Imaging Sciences. These may delay our response to you. Please indicate if your request is more urgent and we will try to accommodate this.
I am writing a NIH grant. When should I ask for a quote?
Before you submit the grant application to NIH. We are able to provide cost quote information at any time for a wide variety of budgetary needs.
When can I begin scheduling my study patients for radiologic exams?
Do not schedule patients until you have received a ledger number from ORPA and we have created a dedicated requisition. These are required to ensure proper billing and scheduling of the exam.
What are the billing procedures for a Clinical Trial?
On a weekly basis you will receive CMS-1500 forms from the Department of Imaging Sciences for studies completed during the preceding period. This is generated from the IDX billing system with the fees corrected to reflect the cost quote you received during study start-up. These should be checked for accuracy and completeness, then payment submitted promptly by 312 Requisition to Sue Bansbach at P.O. Box 278992. For discrepancies, please contact, Sue via e-mail or at (585) 341-4971.
The hospital will draw directly from your ledger for the technical charges.
Which requisition do I use?
The Department of Imaging Sciences creates a customized requisition(s) for each clinical trial. This is sent electronically to either the study coordinator or departmental administrator as you may have indicated. This requisition has the technical, contact and billing information required for correct registration and service. This ensures that the patient or his insurance does not get charged inadvertently.
What is the number starting with an “X”?
Each trial is assigned an identifier by Imaging Sciences starting with the letter X. This helps to distinguish trials within the billing system. Please note this “X” modifier on any correspondence to the department.
What are the differences between the hospital and professional fees? How are they determined?
The hospital bills the technical component for ownership, maintenance and operation of the imaging equipment. The Department of Imaging Sciences bills the professional component for supervision and interpretation of all studies on patient and human volunteers. The fees are based on existing published price schedules.
Are there any additional fees associated with a clinical trial?
For imaging, processing and archiving beyond what we routinely provide, there may be additional fees charged to meet your needs. Please provide as complete information as possible at the time of request so that we can accurately determine all imaging and incidental service fees.
I have forms that need to be completed for each scan. Can Imaging Sciences do this?
In general, we strongly encourage trial personnel to complete their own forms and paperwork. In cases where this is not possible, the technologists and/or radiologists can complete the paperwork, however there is a charge for this service.
What form of hard copy is created?
We are an all-digital department. Your exam will be digitally archived but if needed, can also be copied free of charge onto a CD. Exams can be de-identified as required by your protocol. Contact the Film Library at (585) 275-5368 for your hard copy requests. Standard film copies of your exams are available as well through the Film Library, at a cost of $15.00 per sheet.
If you have hard copy needs in addition to what we routinely provide, please discuss this at the time of quote and with the imaging supervisor from the area in which you will be acquiring exams.
My sponsor needs the data in a special format on their own media. Is this possible?
Perhaps. Contact the supervising technologist of the imaging modality. There may be an extra charge for this.
Does every patient receive a professional interpretation?
Yes. For JCAHO compliance, liability reasons, and good patient practice, every patient or human subject enrolled in a study and imaged at University of Rochester facilities receives a professional interpretation of his/her exam. A report is provided to the designated responsible physician.
My sponsor is now requesting additional films of past patients. What do I do?
Contact our Film Library at (585) 275-5368. There may be an extra charge incurred for this.
I want to arrange for collaboration beyond image interpretation from a radiologist or Department of Imaging Sciences researcher.
Your quotation will reflect routine professional support and interpretation provided by the Department of Imaging Sciences. Additional collaboration can be arranged on a case-by-case basis. This would be a supplement, not a substitute, for the imaging provided by the Department.

Contacts

Before contacting personnel below, please check our FAQ section.

For Inquiries, to Start a New Trial or for Requisition Questions:

JoAnne M. McNamara, Rn-c, MS, Clinical Trials Coordinator for the Department of Imaging Sciences. Phone: (585) 275-8849
Fax: (585) 756-8290

For Billing Inquiries:

Sue Bansbach, Imaging Sciences Billing Department
Phone: (585) 341-4971
Fax: (585) 506-0141

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