Announcements Archive
- Device Trial Listserv Created
- Caution: Layered Services
- Caution: Smaller Pharmaceutical Companies
- Investigational Drug Services Request for Estimate/Confirmation of Services
- PI Salary Support for Industry Sponsored
Trials - Ordering Unexpected Sponsor-Funded Services
- C&G Expenditure and Close-out Policy for Industry-Sponsored Clinical Trials
- New CTC Item on Introductory Questionnaire
- CMS Clarification MLN SE0822 Revision
- Invoice Payment Instructions
CTC Document Deferral for Non-Industry, Grant Proposals - CTC HSC Scope
- New and Improved Changes in the Study Registration Process!
- Important New Requirement for Paying Shands PFS Invoices
- Study Registration Form Exemption
- New Changes in Shands at UF Laboratory Process
- Updated Modifier Requirements
- New Changes in Shands Research Account System
- IMPORTANT NEW REQUIREMENTS
- Attention Coders, Administrators, and Researchers!
- New Look for CTC Newsletter & More
- New CTC Classes
- Welcome to the launch of our new website!
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Device Trial Listserv Created
July 27, 2009 In order to simplify the process of notifying multiple parties within Shands Hospital and University of Florida Physicians (UFP) billing staff prior to Device Study Implantation/Use, the Clinical Trials Compliance (CTC) office has created a listserv, DEVICE-TRIALS-L@LISTS.UFL.EDU, which includes all parties to be notified including PFS, BAR and Shands Admissions/Registration staff. Please include the patient's name, MR#, name of study and service to be performed.
Be sure to consult the Device Trial section of the CTC website for complete instructions and procedures that include important steps to be taken during the Pre-Award process, before any patient enrollment can occur, as well as the use of special service order forms when the sponsor funded account is responsible for payment.
Caution: Layered Services
June 1, 2009 Shands research order forms were created to more clearly identify services that are part of studies under the auspices of a R99. However, there are still procedures that are being billed to third-party insurance companies in error when there is a secondary service connected to a primary procedure (i.e., pathology slides conducted by Shands Laboratory as a result of a biopsy procedure). Research teams should provide a second research order form to primary ancillary department when there is a secondary service being conducted by a secondary ancillary department.
Caution: Smaller Pharmaceutical Companies
June 1, 2009 Due to the economic downturn, several smaller pharmaceutical companies can no longer make payments on contracted clinical services. It is suggested that research teams be cautious when accepting clinical trials sponsored by these smaller companies and make attempts to budget costs as up front study startup costs.
Investigational Drug Services
June 1, 2009 Investigational Drug Services Request for Estimate/Confirmation of Services Now Located in the Getting Help section of the CTC website.
Ordering Unexpected Sponsor-Funded Services
March 19, 2009 A compliant process for ordering unexpected, sponsor-funded services (defined as any service that was not in the original Study Registration Form plan and is to be paid for by the study. This could include services that are urgent, related to subject injury, missing service-error found from original SRF, added-on, or new) has been developed by the Research Administration & Compliance (RAC) Office, Shands Hospital and Faculty Group Practice (FGP). For details regarding the process, please click here. Details regarding the usual process for expected, sponsor-funded services can be found here.
C&G Close-out Policy for Industry-Sponsored Clinical Trials
March 1, 2009 The University of Florida Contracts & Grants (C&G) Office has issued an Expenditure and Close-Out Policy for Industry Sponsored Clinical Trials. Prior to sending a signed Closeout Memo to C&G, please send your completed Participant Service Tracking Log to the Research Administration & Compliance (RAC) Office. Should you need any assistance completing this log, please contact RAC at 273-5946. For any questions regarding the Expenditure and Close-Out Policy, you may contact C&G directly at 392-1235.
New CTC Item on Introductory Questionnaire
February 2009 The Health Science Center Institutional Review Board (IRB) has revised its Introductory Questionnaire (IQ) to include an alert box (see below) which will assist researchers in determining when their studies should be evaluated for fiscal and billing risk. You may view the updated IQ at http://irb.ufl.edu/docs/frm-iq.doc. This box will be a reminder if you have a study with human subjects and services and have not yet submitted your CTC paperwork to the RAC. Use the handy link provided to contact the RAC.
Invoice Payment Instructions
February 1, 2009 The HSC College Departments receive invoices for patient care costs (797100 account code) that contain patient health information (PHI). For invoices containing PHI, complete the HSC-PHI Voucher Cover Sheet instead of sending the UB-04 and CMS-1500 to Disbursements/Payables (http://fa.ufl.edu/forms/; Form name: FA-PDS-PHIVC HSC-PHI Voucher Cover Sheet). Disbursements will upload the HSC-PHI Voucher Cover Sheet to the PeopleSoft system in place of the invoices. It is the department’s responsibility to keep the original invoices along with other study documentation in the department for audit purposes. The departments may include multiple invoices in one voucher for patient care costs only. Use a sequential numbering system that your department uses and tracks. PeopleSoft will notify the department if a duplicate invoice number is used. This number will be placed on the “Departmental Invoice #” line on the HSC-PHI Voucher Cover Sheet that is faxed to Disbursements/Payables. The “Invoices Referenced” line is where you will list all Invoice/Patient Control Number(s) paid by this Voucher. The list should match what is referenced in Regular Entry, Payments tab, Messages hyperlink (which is being used to list the invoice numbers on the vendor check).
CMS Clarification MLN SE0822 Revision
January 7, 2009 CMS released a revised version of the MLN MattersSE0822. They removed the prior Q&A #1 which referred to clinical trials. Upon insurance denials, if study participants were not billed for the denial, then Medicare could not be billed either. See http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0822.pdf. UF will no longer accept sponsor Clinical Trial Agreement contingency language in payment considerations, deductibles and co-pays or subject injury language.
CTC Document Deferral for Non-Industry, Grant Proposals
January 7, 2009 The RAC office will now defer all CTC paperwork for grant applications that are submitted to the RAC office only for Non-Industry human subjects with services clinical research. This should decrease the workload and increase accuracy since it is difficult in completing the documentation when all the necessary services are not often known. This documentation will still be required prior to starting the study. Once the award is confirmed, the applicable CTC documents should be completed and submitted to the RAC office allowing adequate time for review and submission of the documents including the Study Registration Form process for obtaining an R99 number. This will assist the research team in obtaining any applicable discounted prices and staying compliant with state and federal regulations. Remember, it may take time to obtain the Confirmation of Services required prior to submission so be sure to begin the process no later than the IRB submission. It is expected that the department will track their submission to avoid any unnecessary delays. This change is effective immediately.
CTC HSC Scope
January 1, 2009 The Office of the Senior Vice President for Health Affairs has extended the Research Administration and Compliance (RAC)/Clinical Trials Compliance (CTC) Office oversight to all Health Science Center colleges for human subject and medical services studies. The RAC will work closely with the other College administrative offices. This includes the Colleges of Dentistry, Nursing, Public Health & Health Professions and Pharmacy in addition to the College of Medicine. Stay tuned for further updates and announcements as plans are being developed and implemented. For any questions, please contact CTC at 273-5946.
New and Improved Changes in the Study Registration Process!
October 1, 2008- The process has been redesigned for obtaining ‘Confirmation of Services’ from Shands Ancillary Departments and Faculty Group Practice (FGP) Liaisons, ‘Discounted Research Prices’ from Shands Financial Planning &Analysis (FP&A) and FGP, and new R99 assignments. The purposes of this business process redesign effort are as follows:
- Reduces the time required to obtain research prices and R99 numbers
- Eliminates redundancies in tasks, which increase time and potential for errors
- Supports improved version control of documents
- Creates greater transparency and improved lines of communications
- Establishes one point of contact to inquire regarding the status of submissions.
Please review the new Study Registration Process Instructions
Changes to the current process include:
- Research Teams will obtain written confirmation of feasibility for sponsor paid services from Shands Ancillary Departments and/or FGP by using the new ‘Confirmation of Services’ (COS) Form. Researchers will communicate directly with the Ancillary Departments and FGP in determining correct study services and codes before submitting a study proposal packet to RAC.
- The ‘Discounted Pricing Request (R99) for Shands & FGP Clinical Services’ page of the ‘Study Registration Form’ has been eliminated. Research Teams will no longer need to transcribe study tests or procedures onto this page. Instead, Research Administration & Compliance (RAC), Shands & FGP staff will use the information on the COS Forms to produce Discounted Price Lists and assign an R99 number for the study. The goal will be 10 business days from the time Researchers receive RAC approval of the study proposal packet/documents to receive the discounted pricelist and R99 number.
Please review the Study Registration Process Instructions for further details and contact us if you have any questions about this redesigned process (COM-RESEARCH-ADMIN-COMP-L@LISTS.UFL.EDU). For all other questions or assistance related to obtaining/completing/submitting a Confirmation of Services (COS) Form, please contact Deborah Vergara at dverga@ufl.edu or 273-7818.
Important New Requirement for Paying Shands PFS Invoices
September 25, 2008- Shands PFS: For invoices for study funded services, Shands PFS has requested that, for correct payment posting to occur, be sure to include the patient control number (box #3a on the UB-04) that is provided to you on the invoice as the invoice number to be printed on the check for invoices issued after March 2008.
To voucher multiple participants or invoices in PeopleSoft, UF Purchasing and Disbursements has suggested utilizing the Message hyperlink under the Payment tab that will allow 70 characters that will print on the check.
You will be able to enter up to 6 patient control numbers into this box (including commas and spaces) which in turn will allow 6 line items to print on the check. You may also pay for patient services with your P-Card. Do not use the R99# any longer on the voucher for invoices that were issued after March 2008. Contact the PFS billing department for questions or error correction.
Faculty Group Practice (FGP). For FGP invoices, follow the same procedure above. Note that instead of a Patient Control Number that Shands PFS uses, there is a Patient Account Number (also called the Invoice Number) that you would insert into the same fields.
Study Registration Form Exemption
September 10, 2008- Research teams will no longer need to submit a Study Registration Form for studies that do not include a drug, device, or treatment AND for which all services in the trial will be billed to Medicare/insurance/patient (all M's on the Study Registration Form billing grid). For example, patients consent to a study while they are seen for a liver biopsy procedure that is considered standard of care. The study requires the study coordinator to draw blood samples after the procedure that will be sent to a core lab. All participant services in the trial are routine costs that will be billed by FGP and/or PFS to a patient and/or their 3rd party payor and would therefore not require a Study Registration Form to be submitted to the Research Administration & Compliance (RAC) Office. For any questions, contact Debbie Vergara .
New Changes in Shands at UF Laboratory Process!
May 8, 2008 - The CTC Office has posted the NEW Shands at UF Laboratory/Pathology Lab Ordering Process, Process for Obtaining R99 Price Quotes, and the sample Lab R99 Order Form on the CTC Website.
Updated Modifier Requirements
April 8, 2008 - Important new requirements implemented by the Centers for Medicare & Medicaid Services (CMS) related to clinical trial billing.
New Changes in Shands Research Account System
February 25, 2008 - Shands Hospital and its ancillary departments will be kicking off a "Research K account" initiative to streamline clinical trials billing processes.
Important New Requirements
February 12, 2008 - Important new requirements implemented by the Centers for Medicare & Medicaid Services (CMS) related to clinical trial billing.
Attention Coders, Administrators, and Researchers!
February 20, 2008 -
The CTC Office is hosting an open forum to discuss the NEW REQUIRED clinical trials Modifiers.
February 25, 2008: 1:30-3:00pm
OR
March 7, 2008: 9:00-10:30am
McKnight Brain Institute, Room LG-101A
(Deweese Auditorium)
New Look for CTC Newsletter & More
September 6, 2007 - Visit the latest issue of our CTC Newsletter to view the new look. We have expanded the FAQ’s webpage and added gatorlink password protection to allow us to provide you with more details in answering your questions
Is your sponsor funding any participant clinical services? Be sure to keep track! Pre-closeout audits will require documentation. Not sure how? Register for the new Post-Award Training,”Why Track Services Now? Save Time and Money Later!”. This training addition is your next best step in reducing RISK.
New and Updated Forms are available to help you in your CTC work.
'Getting Help > Contact: Who can help?'
is being continuously updated as our CTC team grows.
Please bookmark the CTC Website so we may keep you up to date on procedures, training registration, directions and contact information.
P.S. - CMS is proposing changes on October 19, 2007 to their ‘Medicare Clinical Trial Policy (CTP). We will contact you when the changes are finalized and we have analyzed the impact on our CTC activities.
Yvonne Brinson, RN, MHSc
Director, Clinical Trials Compliance Office
ybrinson@ufl.edu
New CTC Classes
January 14, 2007 - As of February 14, 2007, new materials are now required for the Pre-Award Proposal Process for the Gainesville Campus COM! Find Out More
Register Now for CTC Classes:
All faculty and staff involved in Clinical Trials research are encouraged to attend training regarding the new Clinical Trial Compliance (CTC) processes and tools.
Also, see COM Gainesville Campus Department Chair Announcement
This new website is designed with both the novice and experienced researcher in mind.
See GatorLink Password for help in accessing some protected CTC Website pages.
As we attempt to make a complex web of Clinical Trials Compliance information both easily accessible and more organized, please help us in making this website a success by sending your suggestions and feedback to our office.
Welcome to the launch of our new website!
December 01, 2006 - Beginning on February 14, 2007, new materials will be required for the Pre-Award Proposal Process for the Gainesville Campus COM. This new website is designed with both the novice and experienced researcher in mind. As we attempt to make a complex web of Clinical Trials Compliance information both easily accessible and more organized, please help us in making this website a success by sending your suggestions and feedback.
