TIME AND STUDY COLLECTION SYSTEM (TASCS) CLINICAL RESEARCH BUDGETING/BILLING SYSTEM AND PROCESS USER GUIDE

Transcription

1 Academic Health Center, University of Minnesota Fairview Health Systems University of Minnesota Physicians TIME AND STUDY COLLECTION SYSTEM (TASCS) CLINICAL RESEARCH BUDGETING/BILLING SYSTEM AND PROCESS USER GUIDE Version Date: September 3, 2008

2 TABLE OF CONTENTS 1. HISTORY OF THE TASCS DATABASE BACKGROUND OF BUDGETING/BILLING COMPLIANCE IN CLINICAL RESEARCH 5 3. WHAT GOES INTO TASCS? TIME FRAME OF APPLICABLE CLINICAL RESEARCH SUGGESTED ROLES AND RESPONSIBILITIES... 9 Investigator... 9 Protocol Contact/Research Coordinator... 9 Billing Contact/Administrator... 9 Service Providers... 9 Web Application Support Specialist...10 Academic Health Center (AHC) Information Systems (IS)...10 Institutional Review Board (IRB)...10 Sponsored Protocols Administration (SPA)...11 Assistant Vice President for Research Academic Health Center GENERAL INFORMATION NAVIGATING IN TASCS Getting User Access to TASCS...12 Logging In to TASCS...13 Saving and Timing Out THE PROCESS STEP BY STEP Researcher Responsibilities...16 Protocol Entry Screen...18 Frequently asked questions about the Protocol Entry screen:...19 Visit Entry Screen...20 Select Services Entry Screen...23 Service Provider Responsibilities...26 Provider Pricing Entry...27 Researcher Responsibilities...28 Account and Lab Set-Up Entry Screen...29 Service Provider Responsibilities...31 Researcher Responsibilities

3 Complete Subject Entry Screen...33 Studies with a Certificate of Confidentiality...34 Complete Subject Tracking Form Entry Screen...35 Service Discrepancy Entry Screen COMPLIANCE Reports APPENDIX A APPENDIX B User Field Definitions APPENDIX C APPENDIX D Process Flow APPENDIX E AHC Policy APPENDIX F UMP Policy APPENDIX G Fairview Policy APPENDIX H Service Locations APPENDIX I Fairview / UMP Research Contacts FAIRVIEW HEALTH SERVICES...78 UNIVERSITY OF MN PHYSICIANS...78 ANCILLARY DEPARTMENT CONTACTS

4 1. HISTORY OF THE TASCS DATABASE Established, 1998, by the Research Services Organization to support clinical trial business (not clinical trial data) management Developed internally by AHC Information Systems developer Rolled out in July, 1999 Viewing rights for select reports given to department administrators in 2004 Cancer Center Clinical Trials office implements TASCS for time card/billing in fall, 2007 Budgeting/billing compliance TASCS upgrades summer, 2008 Upgraded TASCS in production mode August 18,

5 2. BACKGROUND OF BUDGETING/BILLING COMPLIANCE IN CLINICAL RESEARCH Clinical research is a fundamental and critically important component of any Academic Health Center s mission. It is also an activity that is highly regulated, deeply complex and thus, carries an inherent risk. Locally, as well as nationally, there has been a lack of communication intra- and inter-organizationally regarding clinical research processes. Clinical trial budgeting and billing is one of those processes that has become an identified risk area. Historically, there have been very few, or no, policies and processes defining or guiding this activity. The University s Academic Health Center, UMPhysicians and Fairview Health Services have collaborated to create organizational policies in order to address clinical research budgeting and billing. The goal in creating policies is to foster compliant clinical research budgeting and billing across our organizations. Elements of a successful program include the following: Integrate language and practice consent form, clinical trial agreement, billing practice Define payers for protocol services prospectively Identify research participants within the providers systems Identify research related services at point of care assign to correct payers Correctly code claims A process diagram has been crafted to demonstrate the steps involved in implementing the budgeting and billing policy. The process diagram can be found in Appendix D of this manual. The AHC Database (TASCS) is a central tool developed to help support and manage the process. 5

6 3. WHAT GOES INTO TASCS? The AHC policy states that clinical research meeting the following definition must be entered into TASCS. Clinical research is defined as a systematic investigation, including research development, testing and evaluation involving human subjects, their data, records or tissue and is designed to develop or contribute to generalizable knowledge. Clinical research meeting the Institutional Review Board (IRB) criteria for exemption (per 45 CFR ) does not have to be entered into the AHC database. Humanitarian Use Device (HUD)/Humanitarian Device Exemptions (HDE) According to federal definition (21 CFR 814), HUDs/HDEs are not clinical research. However, the same regulation also requires IRB approval to use these devices and Medicare regulations require that the HDE number appear on any submitted claims. Therefore, information related to the use of HUDs/HDEs must also be entered into the AHC Database. Until further notice, the following clarifications to implementation of the policy will be enforced. Please read the following clarifications carefully. Type of protocol For ongoing studies that will use Fairview and/or UMP to provide services required by the protocol (services required to answer the research question) TASCS Screen to complete Protocol Entry Visit Entry (for each visit defined by the research protocol do not have to complete the check boxes next to the visit Subject Entry (for each ACTIVE subject in the study - inactive/completed/withdrawn subjects do not have to be entered) Subject Tracking Form Entry (for each research visit for ACTIVE subjects that occurs on or after September 1, 2008) 6

7 For new studies that will use Fairview and/or UMP to provide services required by the protocol (services required to answer the research question) Protocol Entry Visit Entry (for each visit defined by the research protocol services needed check boxes must be completed for ALL services required to answer the research question) Select Services Entry (all services must be entered whether they will be provided by Fairview, UMP or some other provider) Account/Lab Set-Up Entry Subject Entry Subject Tracking Form Entry Question 1 Do completed subjects enrolled in ongoing studies need to be entered into TASCS? 2 If the study remains open with the IRB (e.g., for data analysis), but all subject visits are completed, does the study need to be entered into TASCS? 3 Do all new protocols need to be entered into TASCS if no tests, procedures, clinic space, clinic visits, physician time, lab services, pharmacy services or hospital services will be required from UMP or Fairview to carry out the protocol? 4 If the ongoing study includes active participants, but no services from UMP or Fairview will be required to carry out the protocol, does it need to be entered into TASCS? 5 Our research involves consenting subjects and conducting focus groups and surveys. There are no clinic visits, labs, procedures, etc. Do these studies need to go into TASCS? 6 Do we have to enter our new studies into TASCS when we never charge the patient (or insurance) for any services? Any services we need are always paid for by the study. 7 Does the study have to go into TASCS if we re only using GCRC services? 7 No No Response Not at this time. You are welcome to add these protocols to TASCS; however, you are not required to enter them. No Not at this time. You are welcome to add these protocols to TASCS; however, you are not required to enter them. If your protocol requires any tests, procedures, clinic space, clinic visits, physician time, lab services, pharmacy services or hospital services that will be provided by Fairview or UMP, the protocol must go into TASCS. Consult with the GCRC to determine if they are purchasing services from Fairview or UMP for your protocol. If not, you do not need to enter your study into TASCS. If the GCRC is using Fairview or UMP services for your protocol, then the study must go into TASCS.

8 4. TIME FRAME OF APPLICABLE CLINICAL RESEARCH 1. Applicable clinical research means a clinical research protocol that is planned, initiated or is ongoing as of September 1, a Planned means study is undergoing consideration and feasibility assessment 1.b Initiated means a clinical research protocol that has been submitted to the IRB and has been granted approval OR is pending approval. 1.c Ongoing means the clinical research protocol remains open for enrollment, or enrollment is closed but existing subject visits that will require services from Fairview or UMP continue. For these studies, only the following screens need to be completed: o Protocol Entry o Visit Entry o Subject Entry o Subject Tracking Form Entry 2. Clinical research protocols that are completed on or before September 1, 2008 do not need to be entered into the AHC database. 2.a Completed means closed with the IRB. 3. The same time parameters are applicable to HUDs/HDEs. 8

9 5. SUGGESTED ROLES AND RESPONSIBILITIES Defining roles and responsibilities will lend clarity and improve efficiencies in the overall research process. The following are suggested responsibilities related to using TASCS - categorized by role: Investigator May enter clinical research information for each clinical research protocol into TASCS. Print a copy of the billing grid report, sign it, and submit it with the initial IRB application and the final SPA Proposal Routing Form (PRF). Update TASCS within 72 hours of the following events: each subject/participant who signs an initial consent form, each subject/participant visit that occurs, and each subject/participant who ends participation in the clinical research. Protocol Contact/Research Coordinator If delegated to the Protocol Contact/Clinical Research Coordinator by the investigator: enter clinical research information for each protocol into TASCS. Print a copy of the billing grid report, obtain principal investigator s signature, and submit signed billing plan with the initial IRB application and the final SPA (PRF). Update TASCS within 72 hours of the following events: each subject/participant who signs an initial consent form, each subject/participant visit that occurs, and each subject/participant who ends participation in the clinical research. Billing Contact/Administrator Review the PRF for signed billing grid report. Assist with purchase order preparation based on budget. Monitor and review reports in TASCS as a tool to assist ongoing account management. Service Providers Service providers, in this context, are employees of University of Minnesota Physicians or Fairview Research Administration. Service providers will assist investigators in determining whether or not the clinical research protocol meets 9

10 criteria for a Qualifying Clinical Trial under Medicare s policy. They will continue to provide research prices and set up research billing accounts. Providers will establish a process to identify research participants in applicable systems and use TASCS information to help ensure charges are on the correct billing accounts. They will also facilitate research coding on claims. Web Application Support Specialist Designs, plans, and coordinates end-user TASCS training. Provides assistance to end-users including assistance with data entry when necessary. Manages TASCS access including collecting, reviewing and processing Access Request Forms, providing correct access privileges, monitoring access and removing access to TASCS as staff and responsibilities change. Manages relationships with end-users, web application developer and external service providers (Fairview and UMP). Develops system documentation including preparation and maintenance of a TASCS User Guide. Identifies technical barriers and end-user concerns and initiates resolutions independently as appropriate or in collaboration with the web application developer. Participates in the development of reports for various stakeholders including end-users and service providers. Participates in the development of policies, procedures, and standards for ensuring the integrity of the database. Monitors TASCS reports to measure compliance with the Policy for Budgeting/Billing Compliance in Clinical Research and communicates compliance concerns appropriately. Academic Health Center (AHC) Information Systems (IS) Writes and maintains code for web application. Resolves technical barriers and end-user concerns, as appropriate. Participates in the development of reports for various stakeholders including end-users and service providers. Participates in the development of policies, procedures, and standards for ensuring the integrity of the database. Institutional Review Board (IRB) Serves as a checkpoint to help assure congruent language and practice in the research consent process. Reviews language in the consent form regarding cost to the participant and matches information to the signed billing grid report. Notifies principal investigator when discrepancies are identified. Final IRB approval may not be granted until discrepancies are resolved. 10

11 Sponsored Protocols Administration (SPA) Serves as a checkpoint to help assure congruent language and practice in budgeting and billing. Reviews the contract language, proposed budget and signed billing grid report to look for uniformity. Notifies principal investigator and request revisions if discrepancies are identified. Contract or agreement may not be executed until discrepancies are resolved. Assistant Vice President for Research Academic Health Center Communication lead, and AHC budgeting/billing for clinical research policy owner. Responsible for policy compliance. 11

12 6. GENERAL INFORMATION NAVIGATING IN TASCS Getting User Access to TASCS Cancer Center Clinical Trials Office and Office of Clinical Research staff who had access to the previous production version of TASCS do not have to complete a TASCS Access Application form. However, all of these users must complete training in the upgraded version of TASCS. Before access to TASCS is granted, each prospective user must complete a TASCS Access Application form (see Appendix A on page 47). The application is also available electronically, via the Office of Clinical Research website: Researchers and research staff will be asked to identify one or more of the following roles to which they should be assigned: investigator, protocol contact and/or billing contact. Individuals may select all three if they choose. Selecting a role or roles does not mean an individual must serve in that role to view information in TASCS. Service providers, IRB and SPA users should indicate their affiliation on the TASCS Access Application Form. If you have any questions about how to complete the TASCS Access Application Form please call Trung Ngo at The steps are: A. Complete and print the signature page. Scan and to TASCS Web Application Specialist at ngox0035@umn.edu B. If you need a supervisor signature, you should complete the form and forward it to your supervisor for approval. The supervisor may approval to the TASCS Web Application Specialist at ngox0035@umn.edu C. You may also choose to complete and print the signature page and then send it via intercampus mail to: 12

13 Trung Ngo TASCS Web Application Specialist Mail Code Delaware Street SE Minneapolis MN Applications will be processed as soon as possible, and always within one business day of receipt. Applicants will receive an notice that access has been granted. Security in TASCS All persons granted access to TASCS will have read and write privileges in the system. TASCS will record the person responsible for the last data changes made to any field in the system. Please be careful when viewing TASCS screens. Except for the following users, TASCS access will be granted based on DeptID. Careful completion of the DeptID section of the TASCS Access Application form will insure access to the information users need. DeptIDs can be added and deleted as needed for each user. Exceptions to DeptID access include: Cancer Center Clinical Trials Office (access granted based on protocols entered by CTO staff and/or CPRC number) Office of Clinical Research (access granted based on protocols entered by OCR) Institutional Review Board (access to all protocol screens and all reports except the researcher s version of the Subject Tracking Form Report) Sponsored Projects Administration (same access as the IRB) Service Providers (access to all) Logging In to TASCS The production address for TASCS is In production environments, the log in screen defaults to the University x500 ID validation screen. 13

14 University employees: University employees will use this screen with their x500 ID and password to log in to TASCS. Non-university employees: Non-University employees should click on the AHC Login button at the top of the screen to get to a new log in screen. Non- University employees will need to have a username and password assigned to them via the new user set-up application process. Saving and Timing Out TASCS will prompt the user to save work before exiting screens. Some screens allow two options Save and Save/Submit. Users should choose Save while still working on the entry screen. Once a screen is complete, choose Save/Submit. Selecting this option will send notification to service providers that your request is ready for processing. While TASCS allows some amount of time before timing out, users are encouraged to save work frequently and whenever data entry in TASCS is interrupted. When attempting to close a TASCS entry screen before saving, the following message will appear: 14

15 The following navigation tools may be useful to use when entering information in TASCS: Keys Alt + Left Arrow Alt + Right Arrow ALT + D HOME END TAB SHIFT + TAB CTRL + A CTRL + C CTRL + V Description Back a page. Forward a page. Select the address bar so you can enter a new URL Brings you to the top of the page Brings you to the bottom of the page Skip to the next field Skip to the last field Select all Copy Paste 15

16 7. THE PROCESS STEP BY STEP The following information describes the data entry and communication process from beginning to end. Sections of the process are divided between Researcher Responsibilities (most commonly meaning either investigator or protocol contact responsibilities) and Service Provider (meaning UMP or Fairview) responsibilities. A complete list of all TASCS entry screen fields can be found in Appendix B starting on page 48. It is important to guard against the duplicate entry of protocols in TASCS. Researchers can check a list of protocols already entered in TASCS by going to the Edit menu and choosing Protocol. Searching by PI will yield the list of protocol short titles, sponsors, etc. that will help users determine whether or not the protocol might already be entered. Whenever there is a question the user should check before entering a new protocol. It is recommended that the primary protocol contact for a protocol be responsible for setting up new protocols in TASCS but researchers and departments can determine how to best assign responsibilities. The Web Application Support Specialist will, on a regular basis, search for duplicate entries and work with protocol contacts to correct any multiple entries of protocols in TASCS. Researcher Responsibilities Adding a new Sponsor, Principal Investigator, Billing Contact or Protocol Contact Every effort will be made to prevent duplicate entries of sponsors, and persons (including investigators, billing contacts, protocol contacts, etc.) in TASCS. When entering a new protocol in TASCS, if the Sponsor or Person is not listed as a current drop down option, the Web Application Support Specialist will enter the new Sponsor or Person into TASCS. When a sponsor, investigator, billing contact or protocol contact must be added the user should or fax the required new information to the Web Application Support Specialist at: 16

17 U of M, Academic Health Center TASCS Web Application Specialist Mail Code Delaware St SE, Minneapolis MN Fax: need to correct Phone: Information needed to enter a new Sponsor or new Person in TASCS can be found in Appendix C (page 60). It is important to note that every Sponsor entered in TASCS has a funding source associated with that Sponsor. The selection of the appropriate funding source has implications for assuring the proper rates for research services are applied. If you have questions about the funding source associated with a Sponsor please contact Trung Ngo. For more information about funding sources please see the Sponsor request form in Appendix C (page 63). The IRB and SPA will review a budgeting/billing grid as part of all new protocol applications received after September 1, To prepare a budgeting/billing grid, follow the steps described in the next sections. 17

18 Protocol Entry Screen Before entering a new protocol, go to Appendix B, and find the Protocol Entry Screen list of fields. Until you are familiar with TASCS use the list of fields to review the definition of what should be entered in each field. Fields that must be entered to Save the protocol are marked with a red asterisk on the entry screen. Fields that are required, but not required to Save are indicated with a blue asterisk and must be completed if they apply to the protocol. Fields that are not required can be used at the discretion of the user. Go to the New menu and choose Protocol. The Protocol Entry Screen includes basic information about the study. Remember to Save! TASCS will prompt for required fields data entry before a new protocol can be saved. The field definitions for the Protocol Entry Screen can be found on pages of Appendix B (which starts on page 48 of this manual). Screen 1: Protocol Entry 18

19 Frequently asked questions about the Protocol Entry screen: How should multiple sponsors be attached to a single protocol? Information on this subject will be added to the TASCS manual. TASCS lets you indicate one sponsor in the system. If the protocol is investigator-initiated, choose Investigator-initiated.with the appropriate funding source in parenthesis. If any of the sponsors is a governmental department or agency, list that sponsor in the sponsor field. If the study sponsor is a non-profit entity (University, foundation, etc.) and there is no governmental sponsor, list the non-profit entity in the sponsor field. If all the sponsors are commercial (a business or industry), pick one to list in the sponsor field. In all instances, you may provide the names of other sponsors in the comment section, but they are not required. Which sponsor should be chosen in TASCS when the study is investigator-initiated, but funding is provided by a commercial source (business or industry)? Choose Investigator-initiated (B&I) from the sponsor drop down list. You can identify the commercial sponso s name in the comment field if you like, but it is not required. How do you enter a single IRB protocol into TASCS when the protocol has multiple funding sources and titles? Currently, the study has separate account numbers based on title and funding source? For projects such as these we ll have to use the EFS account string as the unique identifier rather than the IRB number. Each EFS account string will require its own Protocol Entry into TASCS. Work with your department accountant. 19

20 Visit Entry Screen After the Protocol Entry Screen is completed, go to the Edit menu and choose Visit Entry. Search by TASCS number (or any search term of your choosing) for the Visit Entry screen and choose Search. Screen 2: Visit Entry lookup Before entering any data, go to page 53 in Appendix B and find the Visit Entry Screen list of fields. Until you are familiar with TASCS use the list of fields to help you determine which fields are required, and to review the definition of what should be entered in each field. Any fields that are not required can be used at the discretion of the researcher, billing contact or protocol contact. 20

21 Screen 3: Visit Entry sample All data collection time points must be defined and entered as uniquely named visits in TASCS. Visits should be defined based on the protocol time points at which research data will be collected for each subject. Four visit descriptions (startup, consent, date withdrawn, and a reason for the subject withdrawal) are autofilled by TASCS. (The startup visit description is available for business use outside of the budgeting/billing policy but may be used to store optional information about startup activity.) All other visits can be named at the user s discretion. Common labels include numbering visits such as Visit 1, Visit 2, etc. Other possibilities include Day 1, Day 7, Day 14, etc. Visits should include a number, and be identified in the way that will make information most useful to the researcher. 21

22 Check the box for each visit at which any medical or laboratory services will be needed whether they will be provided by Fairview, UMP or any other provider. Medical or lab services refers to tests, procedures, clinic space, clinic visits, physician time, lab services, pharmacy services or hospital services that are required to carry out the protocol. When all available lines have been entered simply hit Save Changes and four more blank lines will be made available. If you discover, after naming visits, that you must add a visit that would occur between visits already named, name a new visit on a blank line and use the Order column to indicate in what order the visit should occur. When you select Save TASCS will re-order the visits. Remember to Save whenever your work is interrupted. Do not select Save Changes/Select Services until all of your visit descriptions have been entered. If you accidentally choose Save Changes/Select Services button and you are not finished entering visits just choose Edit Visits to continue. Please note that you can delete visits from the Visit Entry screen. There is a check box at the end of each Visit row to Delete. Use this button with caution as deleting a visit will delete all stored data related to that visit (services, visits completed, etc.) It is not recommended that users delete visits from the Visit Entry screen after any study visits for subject have actually occurred. When all visits have been named, choose Save Changes/Select Services. The Select Services screen will appear. 22

23 Select Services Entry Screen Screen 4: Select Service lookup Before entering any data, go to page 53 in Appendix B and find the Select Services Entry Screen list of fields. Until you are familiar with TASCS use the list of fields to help you determine which fields are required, and to review the definition of what should be entered in each field. Any fields that are not required can be used at the discretion of the researcher, billing contact or protocol contact. Screen 5: Select Services sample 23

24 Most of the Fairview e-form research request process will be replaced by TASCS. It will no longer be necessary to complete a Fairview e-form for pricing or account set-up activities. Four lines related to Investigational Drug Services (IDS) will be autofilled by TASCS on the Select Services Screen. The service location for IDS services will also be autofilled. All medical or laboratory services (tests, procedures, clinic space, clinic visits, physician time, lab services, pharmacy services, or hospital services that are required to carry out the protocol must be entered on the Select Services Entry Screen whether they will be provided by Fairview/University of Minnesota Physicians or not. Researchers will be asked to enter medical and laboratory services one line for each service location. What this means is that if the protocol will require imaging (MRIs, for instance) at both a Fairview facility and at the UMP Imaging Center MRIs must be listed twice on the Select Services Screen. Enter the name of each test or procedure using the clearest and most specific terms possible to indicate the service needed. For instance, if the MRIs required by the protocol will require the use of a contrast agent, enter MRI with contrast. Service providers will communicate with the protocol contact entered in TASCS whenever more information is needed to make sure TASCS reflects what the protocol requires. After naming the test/procedure, the next field to enter will be to select the service location from the drop down. The Service Location drop down includes: UMMC Clinic UMP Clinic Fairview Clinic (Includes Maple Grove) Fairview Hospital UMP Imaging Center Other Additional information on categorizing or understanding service locations is available in Appendix H. 24

25 If some of the tests/procedures will be performed at multiple locations, enter the service on as many lines as needed to allow for indicating each Service Location at which protocol services may be provided. Note about choosing a location for laboratory services: If the Outpatient Laboratory (first floor PWB) or a hospital laboratory will be used choose Fairview Hospital as the location. If clinic laboratory services will be used choose the appropriate clinic location. If, for example, the protocol will require EKGs to be performed by the Outpatient Laboratory, enter EKG (Lab) and choose Fairview Hospital as the location. Note about one-time or invoiceable services: If the protocol includes services that may be incidental or required only under specific circumstances enter these services (using as clear a description as possible) in the Comment section at the bottom of the Select Services Entry screen. This will allow providers to provide a price for the services. The next field to complete is to indicate how the test/procedure will be paid for at each visit. The drop down options for this field are: Research Account Patient/Insurance Other In some studies, a service might be appropriately billed to patient insurance at some visits but not others. TASCS will allow users to indicate how the service should be billed at each visit or whether it will be provided outside of Fairview or UMP. When all available lines have been entered select Save Changes and more blank lines will be made available. Remember to Save Changes whenever your work is interrupted. Do not select Save Changes/Submit to Fairview and UMP until all services required by the protocol have been entered. If you prematurely select Save Changes/Submit to Fairview and UMP you should contact Fairview to let them know that your request is not yet complete. When all services required by the protocol have been entered on the Select Services Entry Screen, select Save Changes/Submit to Fairview and UMP. Service Providers will receive an automatic (with a copy to the protocol and billing contacts) informing them that there is a protocol for them to review. Researchers will receive a prompt to attach their protocol to an to send to Fairview and UMP. 25

26 Service Provider Responsibilities Review the submitted protocol and billing plan that is now available as a TASCS report (Billing Grid). If the billing plan indicates that the patient/insurance will be billed for study related services, then further review is required to determine if the study is a qualifying clinical trial under the National Coverage Decision (Medicare s Clinical Trial Policy). Alert investigators, early in review, if concerns are identified with the billing plan or if the study is not a qualifying clinical trial. When the coverage analysis is completed, providers will click the Coverage Analysis Complete button on the Protocol Entry Screen. This will initiate a TASCS generated to the Protocol Contact and the Billing Contact to inform them that the billing grid is now ready. Researcher Responsibilities After receiving notification that the billing grid is available, go to the Report menu and select Billing Grid Report. Print the billing grid and have the PI review, sign, and date. Submit the signed/dated billing grid with the IRB application. 26

27 Provider Pricing Entry Screen 6: Provider Pricing lookup Select the appropriate fee schedule from the drop down for each service listed based on the service location. Click on the Write-In service description to advance to the pricing screen. Screen 7: Provider Pricing sample The Write-In service description and desired service location are provided as header information on the pricing screen. Use the drop-down menu in the Service Description column to locate the requested service. The remainder of the row will auto-populate. If additional services are typically needed (e.g., Colorflow Doppler when Echo is requested, or contrast material for Nuclear Medicine tests), add 27

28 the service on the next line. Click the Save button to return to the previous screen. Screen 8: Provider Pricing Entry sample Continue to price each service requested. When finished choose the Completed button. This action generates an notice to the Protocol and Billing contacts that prices are available. Researcher Responsibilities To prepare the protocol budget, go to the Report menu and select Research Prices Report. This report will provide the prices for services to be provided by Fairview/UMP and billed to the research account. This information will be based on the data entered on the Select Services Entry Screen. Submit documents to SPA including consent form and signed/dated billing grid. NOTE: If the consent form submitted to SPA is draft language, the PI is responsible for notifying SPA regarding any changes in the final IRB approved version. When the account number is assigned by SPA request/prepare a purchase order for the research services that will be paid for by the research account. When a purchase order number is available it is time to complete the Account/Lab Set-Up Screen. 28

29 Account and Lab Set-Up Entry Screen Screen 9: Account/Lab Set-up lookup Before entering any data, go to page 55 in Appendix B to find the Account/Lab Set-Up Entry Screen list of fields. Until you are familiar with TASCS use the list of fields to help you determine which fields are required, and to review the definition of what should be entered in each field. Any fields that are not required can be used at the discretion of the researcher, billing contact or protocol contact. Screen 10: Account/Lab Set-up sample 29

30 Screen 11: Account/Lab Set-up sample 30

31 The lab portion of the Account/Lab Set-Up Entry Screen is almost exactly the same as the current paper form used by the lab. Any questions about how to complete the fields on this screen should be directed to Fairview at (612) If you start to enter data in the General Account Information section of the Account/Lab Set-Up Entry Screen you have to complete the section in order to Save Changes. Service providers will receive an alerting them to establish your accounts when you Save Changes for this section. The remaining sections of this entry screen do not need to be populated in order to Save Changes. Complete the Lab Instruction Form section and the Recruitment Posting section as applicable to your protocol. After selecting Save Changes, a new General Account Information section will appear on the Account/Lab Set-Up Screen. This will allow for additional purchase orders to be added. Service Provider Responsibilities An will be automatically generated to Service Providers (with a copy to the Protocol Contact and Billing Contact) for review and set up of account numbers. Fairview Research Administration, UMPhysicians Central Business Office and Fairview Laboratories will review the Account and Lab Set-Up screen. UMPhysicians will assign a Flowcast case number to the study and enter it into TASCS. Fairview will assign hospital account numbers (B#s, S#s, etc.) and laboratory account numbers (U#s) and enter them into TASCS. Providers will communicate with the appropriate contact (either Protocol or Billing) if more information is needed. Providers populate the Provider Accounts section on the bottom of the Account and Lab Set-Up screen and choose the Account Set-Up Complete button. The Protocol and Billing contacts will receive an stating the account numbers have been assigned. The account numbers will now appear on the Protocol Entry Screen and on the Account and Lab Set-Up Screen. Visit specific encounter forms are now available within TASCS and may be printed as needed. 31

32 Fairview Lab will continue to create the laboratory requisitions and send to the requesters. Researcher Responsibilities When enrollment for the protocol can begin and a potential subject is identified follow these steps: Go to the Reports menu. Print visit specific encounter form(s) from TASCS. The visit specific forms will include only those services to be provided by Fairview or UMP and to be billed to the research account. Note about encounter form use: Encounter forms and lab slips signal providers to bill services to the research account. If a service is not listed on an encounter form or lab slip it will be billed, by default, to the subject or to the subject s third party provider. One-time or invoiceable items should be written in the box on the encounter form and indicated, on the Subject Tracking Form Entry screen, as an additional service not pre-printed on the encounter form. Encounter forms can be printed specific to subjects and visits. It is also possible to print a visit specific encounter form that does not include information about any specific subject. If researchers use these generic forms, information about the subject must be handwritten on the encounter form. Note about encounter forms: Visit and subject specific encounter forms will only be available in TASCS if the Select Services Entry screen has been completed. For ongoing clinical research protocols, entering information in the Select Services Entry screen is not required. For these protocols, researchers will continue to use the encounter forms Faiview issued for the protocol. 32

33 Complete Subject Entry Screen Screen 12: Subject lookup Before entering any data, go to Appendix B to find the Subject Entry Screen list of fields. Until you are familiar with TASCS use the list of fields to help you determine which fields are required, and to review the definition of what should be entered in each field. Any fields that are not required can be used at the discretion of the researcher, billing contact or protocol contact. Screen 13: Subject Entry sample 33

34 Within 72 hours of a subject signing a consent form enter information about the subject into the Subject Entry Screen and the date of consent in the Subject Tracking Form Entry screen. By entering the date of consent in the Subject Tracking Form Entry screen, providers will receive an automatic notification that a subject has been enrolled and that a patient case number needs to be assigned, if necessary. The Protocol Contact and Billing Contact will receive an e- mail when the case number has been assigned. Studies with a Certificate of Confidentiality These studies typically have no services billed to insurance. Real initials, date of birth and medical record numbers need not be entered. By indicating, on the Protocol Entry Screen, that the study has or will have a Certificate of Confidentiality, TASCS will autofill placeholder information in the initials, medical record number and date of birth fields on the Subject Entry Screen. This will allow for a billing grid to be created and submitted to the IRB and SPA per the process. There would be no identifying information about subjects within TASCS and the providers would not attempt to flag any patient accounts. Note about case number assignment: UMP will enter case numbers for all subjects entered into the TASCS system on or after August 18, For subjects that were entered into TASCS prior to August 18, 2008 (Office of Clinical Research and Cancer Center Clinical Trials Office UMP will either enter the cases, or provide them to the OCR for entry into TASCS). 34

35 Complete Subject Tracking Form Entry Screen Screen 14: Subject Tracking lookup Before entering any data, go to page 58 in Appendix B and find the Subject Tracking Form Entry Screen list of fields. Until you are familiar with TASCS use the list of fields to help you determine which fields are required, and to review the definition of what should be entered in each field. Any fields that are not required can be used at the discretion of the researcher, billing contact or protocol contact. Screen 15: Subject Tracking Form sample To repeat instructions about this important step, within 72 hours of a subject signing a consent form enter information about the subject into the Subject Entry Screen and the date of consent in the Subject Tracking Form Entry screen. By entering the date of consent in the Subject Tracking Form Entry screen, providers will receive an automatic notification that a subject has been enrolled and that a patient case number needs to be assigned, if necessary. The Protocol Contact and Billing Contact will receive an when the case number has been assigned. 35

36 Also within 72 hours of any of the following actions a visit date in the Subject Tracking Form Entry Screen must be entered. Any subject completing a protocol visit, or Any subject withdrawing from the protocol Before any visit date can be entered users are required to answer yes or no to the following question: Were additional services used at the visit (e.g., not planned for this visit and they were not pre-printed on the Encounter Form or Research Lab Slip)? If there were additional services, indicate by choosing "Yes." If there were no additional services, indicate by choosing "No." Whenever the answer to the question is yes, Service Providers will receive an notification and the Researcher will be prompted to complete another TASCS screen called: Service Discrepancy Entry Screen. This screen looks similar to the original Select Services Screen. Note about added services: One-time or invoiceable items should be written in the box on the encounter form and indicated, by answering the question Y on the Subject Tracking Form Entry screen for the visit, as an additional service not pre-printed on the encounter form. Note about entering consent date: In studies where consent to participate in the study occurs months in advance of any further screening for eligibility, the date of consent must still be entered within 72 hours after consent is signed. Subjects found to be ineligible will have to be withdrawn from the study when it is known they are ineligible. Note about turnaround time for getting patient/subject case numbers assigned: Case numbers will be assigned within two business days, in many cases, one business day. 36

37 Service Discrepancy Entry Screen Screen 16: Service Discrepancy lookup Enter the name of each test or procedure using the clearest and most specific terms possible to indicate the service that was added at the visit. Screen 17: Service Discrepancy sample Indicate where the service was provided. The Service Location drop down includes: UMMC Clinic UMP Clinic Fairview Clinic (Includes Maple Grove) Fairview Hospital UMP Imaging Center Other 37

38 The next field to complete is to indicate who will pay for the added test/procedure at this visit. The drop down options for this field are: Research Account Patient/Insurance Other Remember to Save Changes! Service Provider Responsibilities Flag or track patients who are research participants: UMP creates patient case numbers and enters into TASCS Fairview activates a patient flag in the billing system (PASS) Review TASCS reports daily to close cases and remove patient flags. Daily review of charges on all flagged accounts to determine if charges are on the correct accounts. Add research codes to patient claims as needed. Review TASCS for reports of study closure and close accounts. AHC Responsibilities Under the budgeting/billing compliance policy, study closure will be indicated by completing the field All Subjects Withdrawn Date. This date should reflect the date the last subject enrolled (or to be enrolled) in the study has ended his/her participation. Entering this date is a critical step that should be taken as soon as the last subject to be enrolled in the study has completed his/her participation. Go to the Edit menu and choose Protocol. Find the protocol by using the TASCS number (or any other search option). In the Subject Tracking Form section of the Protocol Entry Screen, enter the date the last subject in the study has been withdrawn. 38

39 7. COMPLIANCE The institutional policies (see Appendices E-G) describe the rationale and procedures for compliant budgeting and billing practices within the AHC, University of Minnesota Physicians and Fairview Health Services. As discussed earlier, this is a heavily regulated activity and is viewed as a high-risk area. Compliance will be monitored and reported to Senior Leadership at the AHC, UMPhysicians and Fairview Health Services. The driving principle used to facilitate compliance is to assist all stakeholders in adhering to the defined processes. Resources are available to help with questions, TASCS has automated several process functions, guidance tools have been developed and training is available. Compliance will be managed as follows: Users who do not enter their study information into TASCS will be reminded to do so. If the requisite data is not entered, within 3 working days after the informal reminder, the TASCS Web Application Support Specialist will make a formal request that the information is entered and copy the AHC Associate VP for Research. If the requisite data is not entered within 5 working days of the formal request, the Associate VP for Research will discuss the concern with the principal investigator. 39

40 8. Reports All reports available in TASCS may be used by Researchers and Service Providers. The following reports are available now. The reports that researchers will most commonly use are listed in bold and italics. TASCS users are encouraged to explore the other reports and consider whether/how storing information in optional fields might be useful. Active Research Subjects Active Study Amendments Budgeted Effort Billing Grid Encounter Form IDE/HDE Study Inactive Study IRB Approval Medical Services Used Protocol Information Purchase Order Expiration Research Pricing Research Subject Study Enrollment Research Visit by Date Subject Tracking Form Subject Tracking Form (IRB) Visit Services 40

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46 APPENDICES 46

47 APPENDIX A 47

48 APPENDIX B User Field Definitions Protocol Entry Field Name * Required Response Entered By Field Definition 1 TASCS # n/a Autofill System Sequentially assigned - 2 digits year; 3 digits protocol 2 PI Y Drop down Web app Principal investigator for the protocol specialist 3 Billing Contact Y Drop down Web app Protocol business manager - the approver of protocol specialist expenses commonly called administrator or accountant 4 Sponsor Name and Type Y Drop down Web app specialist Choose the sponsor (the person or group that wrote the protocol). Each sponsor has a funding type associated: Business/Industry, Federal, State, University, Other (see Appendix C for definitions) 5 Sponsor Protocol # Char, any text AHC User Sponsor assigned protocol unique identifier 6 ClinicalTrials.gov # Char, any text AHC User Clinical Trials.gov protocol unique identifier 7 Short Protocol Title Y Char, any text AHC User Abbreviated protocol name - limited to 70 characters (may use acronyms) 8 Full Protocol Title Y Char, any text AHC User Full protocol title (to match IRB and SPA records) 9 CRO (Contract Research Org) Drop down AHC User 10 Protocol Monitor Drop down AHC User 11 Status Y Drop down AHC User 12 Inactive Year Y, when inactivated Char, any text AHC User 13 Protocol Contact Y Drop down Web app specialist 14 Sponsor Contact Drop down AHC User User select from drop down Contract Research Organization - commonly employed by business and industry sponsors Data monitor assigned to the protocol - person who reviews protocol compliance and data collection Select from drop down options: Active-Approved (ready to enroll); Active-In the Approval Process (work is in process - not ready to enroll); Active-Future Protocol (not working on the protocol yet); Inactive (completed); Inactive (rejected/declined) Year all work on the protocol was completed (or was rejected or declined) - inactivates the protocol in system Protocol contact responsible for direct-to-subject contact - commonly called the research coordinator 15 Department Drop down AHC User Choose the DeptID that will cover this account. Typically, this is the investigator's home department. 16 SPA Contact Autofill System SPA grant administrator working on the protocol 48

49 17 CRO Contact Drop down AHC User Contact person from contract research organization 18 Check the box if you need to purchase labor from Check here if you need a Fairview or UMP. Please note that professional fees do new subcontract with Check box AHC User not require a subcontract. Contact Fairview or UMP with Fairview or UMP questions. 19 EFS Fund Y Char, any text AHC User Check with your department for correct financial system identification numbers. TASCS will enter a placeholder until known. 20 DeptID Y Char, any text AHC User Check with your department for correct financial system identification numbers. 20 Program Y Char, any text AHC User Check with your department for correct financial system identification numbers. 21 Project Y Char, any text AHC User Check with your department for correct financial system identification numbers. TASCS will enter a placeholder until known. 22 Fin Emplid Char, any text AHC User Enter the principal investigator's employee ID number. 23 Chartfield1 Char, any text AHC User Check with your department for correct financial system identification numbers. Enter placeholder until known. 24 Chartfield2 Char, any text AHC User Check with your department for correct financial system identification numbers. Enter placeholder until known. 25 Contract # Char, any text AHC User Financial system number assigned to the contract for the protocol. Check with your department for how to find this number. 26 Fund Char, any text AHC User Fund associated with research account - enter 0000 until known 27 Area Autofill System Department numeric identification code 28 Org Char, any text AHC User University numeric identification code for the protocol - enter 0000 until known 29 Start Date Y Month/Day/Year AHC User Protocol Start Date - enter date of protocol entry until firm date is known (firm date should match SPA records) Projected protocol End Date - enter date one year from 30 End Date Y Month/Day/Year AHC User protocol entry date until firm date is known (firm date should match SPA records) 31 First Contact Date Month/Day/Year AHC User Date site was first approached about the study 32 Final Protocol Receipt Date Month/Day/Year AHC User Date final protocol was received for the protocol 33 Contract Exception Drop down AHC User Used to indicate whether a contract remains open until all work is completed or has a firm end date Used to indicate whether or not the contract with the 34 Payment for Screen Fails Yes/No AHC User funder includes payment for subjects who are screened but cannot enroll 49