About Us » CTC Newsletter
Exciting News from the CTC Office!
Document Coordinator Corner
Education &Training Program
Ask the Auditor
General FAQs
Exciting News from the CTC Office!
The CTC website is an excellent resource for information related to clinical trials. There have been several updates in the past few months regarding New Medicare Modifiers for clinical trials related services, as well as internal Shands clinical trials process changes for study participant registration and research funded account billing practices.
Tracking Services Requirements
As the custodian of the study funded account, the PI/research team members are required to maintain a Participant Service Tracking Log to monitor all sponsor-funded charges associated with the study, to confirm that all services rendered have been charged to the appropriate payor (i.e., grant, sponsor, third party payor), and to confirm that all costs associated with the study have only been recovered once. If any study participants have had study funded services during the current month and there are any problems or outstanding invoices, send the most updated Tracking Log at the end of the month to Faculty Group Practice (FGP) and Shands Patient Financial Services (PFS) as appropriate for monthly reconciliation. At the conclusion of all services conducted for the study, indicate the end date on the Tracking Log and send the final Tracking Log to the Research Administration and Compliance (RAC) office. Register for our Why Track Services: Save Time and Money Later! class to learn more! This training addition is your next best step in reducing RISK.
Clinical Trials Compliance Information Management Project
Recently, the CTC Information Management (IM) Project was initiated to investigate, develop and implement a CTC Information Management Solution to support the fiscal compliance requirements associated with risk management of UF Clinical Trials. Visit our weblink to learn more about the IM Project.
Staff Updates
We are growing to better serve the research community. Check out the CTC Office’s new staff additions.
Be sure to check out the announcements section located on our website’s main page, to view upcoming events and any important news!
Document Coordinator Corner
New Study Review Process
The CTC Office recently launched a new initiative that includes sending informational letters for studies that are submitted to the Research Administration and Compliance (RAC) Office in the College of Medicine. Prior to RAC approval, studies are thoroughly reviewed to ensure that the appropriate CTC forms have been completed and that the billing plan is accurate.
For studies with protocol required technical/professional clinical services, a final review of the study cost and subject injury language is performed after the consent form has been approved and the contract executed (if applicable). At that time, the Principal Investigator or Study Coordinator will be contacted if any discrepancies exist between the consent form, billing plan and executed contract (if applicable). The CTC Document Coordinator, Leslie McElvey, is available to assist with drafting payment and subject injury language.
New Study Initiation Letters
After IRB approval and contract execution, a Study Initiation Letter will be generated for the PI and Study Team, which includes study specific billing compliance information. The letter is mailed to the PI and then electronically emailed to the PI and Study Team. The electronic version of the letter includes links to the CTC website which provides additional billing compliance information and hopefully helps study staff become familiar with the content of the website.
For those studies with complex billing plans (including sponsor funded and Medicare billable services), it is recommended that the PI and Study Team meet with the CTC staff to ensure that the billing plan is clearly defined and all staff are aware of their responsibilities. These new letters and visits were initiated on January 31, 2008 and as of May 23, 2008, 70 letters had been mailed and 6 visits conducted. If you have questions about an existing study and would like to meet with a CTC staff member to review the consent language or study billing plan, please call Idella Philman at 273-5946 to setup an appointment.
Device Trials
“Do not enroll study participants into a Category A or B device trial without our local Medicare Intermediary, First Coast Service Options, Inc.(FCSO) approval if any related services are to be billed to the patient or 3rd party payor.”
Investigational device trials that involve billing Medicare services are subject to approval and annual renewal by our local Medicare Intermediary, First Coast Service Options, Inc. This can substantially affect the amount of time it takes to begin enrollment and can also result in studies being closed to enrollment if the Medicare approval expires.
To help ensure that all actively enrolling device studies which will need to bill services to Medicare are currently approved, we assembled a comprehensive list of studies and worked directly with Shands Patient Financial Services (PFS) to identify any expired or non-approved studies. The CTC Office would like to thank everyone that sent information about their device studies so that the comprehensive list could be created. If you have any questions about the approval/renewal process for investigational device trials, please contact Debbie Townsend or visit http://ctc.health.ufl.edu/preAward/pre_award_Medicare.shtml#DeviceTrials.
Education & Training Program
- Study Registration Form Update: The CTC Office would like to extend its sincere thanks to all who reviewed and contributed feedback to the updated Study Registration Form. These helpful individuals included
| Sandra Bell | Renee Boyette |
| Tina Bradshaw | Heather Cavin |
| Aundrea Corbit | Ann Coutu |
| Kristi Cromwell-Cain | Miriam Hill |
| Sherri Mizrahy | Theresa O’Connell |
| Joy Peter | Pamela Schreck |
| Sandra Smith | Georg Suzuki |
| Cindy Weinbrecht |
- CTC Brown Bag: The CTC Office has successfully held two Brown Bag meetings. These are opportunities for all interested clinical trial personnel to gather at an informal setting to discuss clinical trials compliance. The Brown Bags have focused on promoting coordinator/grant personnel collaboration and tracking participant services. Be on the lookout for announcements regarding the next scheduled CTC Brown Bags and send us your topic suggestions!!
- Departmental Presentations: Several departments have hosted the CTC Office for customized training sessions. Please contact Deborah Townsend at dverga@ufl.edu or (352) 273-7818 if are interested in scheduling a training session for your department.
- Training Updates: We are working on getting a course set up that will specifically address device trials for those of you who are or will be working on any device trials. We are also working on our mandatory training program, which will go into effect soon. Stay tuned for updates!
Ask the Auditor
Welcome!
Welcome to Ask The Auditor. In this area of the newsletter we will keep you informed about the auditing process by answering your questions. 
These can be found under the “Conducting Compliance Reviews” section on the Clinical Trials Compliance website. Do you have an audit question? Send it to CTC-AUDITORS@ufl.edu.
Q. When services are completed on a clinical trial, the Tracking log is to be sent to the auditor. Who else should receive the Tracking Log?
A. If any study participants have had study funded services during the current month and there are any problems or outstanding invoices, Tracking Logs should be sent via email to Heather Cavin at Shands Patient Financial Services (PFS) and Stephanie Jones at University of Florida Physicians (UFP) as needed, for reconciliation to ensure invoices are being received for services performed. Upon completion of services and payment of all invoices, the tracking log should then be sent to an Auditor in the Clinical Trials Compliance Office. You may send the Tracking Log via email to the Clinical Trials Compliance Office at CTC-AUDITORS@ufl.edu.
Q. What will the Auditors do with the tracking log?
A. Our office will acknowledge the receipt of your tracking log via email. You may be contacted should the auditor’s have any questions or clarifications needed. The Auditors will review the tracking log and may elect to audit the study. If your tracking log is selected for an audit the PI will receive a formal Intent to Audit Letter.
Q. What type of results are you finding in your audits?
A. Some of the most common findings we have noted as a result of our audits include the following: duplicate payments for invoices, payment for services that were not study related, incorrect 3rd party billing, and outstanding payment for study related services. Keeping a complete Tracking Log is the best practice of avoiding all of these types of errors. By verifying the completed services were paid by entering in the Voucher information, the Log will provide departments verification of payment for all study related services, confirmation that all services that are not study related are not paid in error, and provides confirmation that duplicate payments have not occurred.
Q. Getting these services paid has been a very frustrating experience. What should we do if we aren’t getting the invoices from Shands or FGP?
A. We understand that this has been a frustrating process for all involved. We have the agreement of Shands PFS and FGP BAR that they will work with departments to ensure accurate invoices are sent timely. You can do your part by sending the monthly Tracking Log for all services conducted that are to be billed to the study funded account. A valuable outcome of the audit findings has been increased communication with Shands PFS. If any study participants have had study funded services during the current month and there are any problems or outstanding invoices, send the Tracking Log to Heather Cavin at Shands PFS and Stephanie Jones at FGP BAR for review as appropriate for monthly reconciliation. The timeliness of this process enables Shands and FGP BAR to verify that 3rd party billing does not occur in error, and allows departments to receive bills for services in a timely manner. Should you continue to experience billing problems, please also contact Heather Cavin and Brenna Markham at Shands PFS and Maggie Phillips at FGP BAR for assistance.nce.
General FAQs
May 2008 FAQs
Q: Are you saying that research teams need to assume Shands’ fiscal responsibilities in addition to their own responsibilities?
A: Research teams are the “custodians” of the research funds. On the front end, research teams have a responsibility to generate a unique billing plan for each individual study and to communicate this billing plan to all service providers (including Shands ancillary departments) participating in the study. Based on this communication, billing appropriately is the responsibility of Shands Hospital. However, on the back end, research teams also have a responsibility to track the services provided during the research study to ensure that the billing plan was properly followed.
Q: Is the paper system that we currently have in place ever going to be replaced with an electronic system?
A: We are currently working on an information management solution to support the fiscal compliance requirements associated with risk management of UF Clinical Trials Research. Please visit http://www.health.ufl.edu/aiss/projects/ctc/index.php for more information about the CTC Information Management project.
Q: Can we pay for study services for participants from a different sponsor funded account that they didn’t participate in as long as it is industry sponsored?
A: No. In order to ensure fiscal compliance for all research studies, it is important to abide by University of Florida directives and procedures. Relative to compliance monitoring, expenditures applied to projects should be reasonable and allocable. Specifically, all costs should be necessary to the performance of the study and should benefit the contract or grant that is being charged. Please see the Finance and Accounting website for further detail regarding this policy.
Q: Is a Participant Service Tracking Log REQUIRED?
A: Yes, a Tracking Log or its equivalent is REQUIRED in order to monitor all sponsor-funded charges associated with the study, to confirm that all services rendered have been charged to the appropriate payor (i.e., grant, sponsor, third party payor), and to confirm that all costs associated with the study have only been recovered once. Upon completion of study services, please send the Tracking Log to the RAC office.
back to top 