Clinical Trial Professional and Technical Fee Billing Procedures 1. Responsibilities: The principal investigator and his/her designees are responsible for: a. Accurately billing medical technical and professional research charges to the grant, the third party payer, or to the research subject. b. Informing the research subject of the charges and how they will be allocated as a part of the informed consent process. c. Completing required documentation to support charges for each research subject. 2. Clinical Trial Charge Matrices*: The primary investigator/clinical research coordinator/designee shall use the Clinical Trial Matrices to identify and accurately charge research-related tests, exams, and procedures. The completed Clinical Trial Master matrix shall be submitted to the Clinical Research Financial Compliance Specialist (CRFCS) along with a copy of the study protocol, informed consent, and pertinent sponsor agreements to ensure consistency, accuracy and completeness. The approved Clinical Trial Charge matrix will then be submitted with the IRB application. The Clinical Trial Charge Matrices appears in the form of an Excel spreadsheet workbook with four distinct page types: * Cooperative Group Studies shall use the CLINICAL TRIAL MATRIX COOPERATIVE GROUP STUDIES Workbook in place of the Clinical Trial Matrices Workbook. a. Clinical Trial Master Matrix required 1. Lists all clinical trial-related technical and professional charges, and whether the charges will be billed to the grant, the third party payer, or to the research subject. Note: If all charges will be billed to insurance, there is still a need to detail procedures/treatments. The V70.7 research code and/or modifiers 1 must be listed on those charges to flag services rendered to a research subject before submission to insurance. 1 Modifiers prior to 2008 include: QA: FDA investigational device exemption QR: Item or services provided in a Medicare specified study QV: Item or service provided as routine care in a Medicare Qualifying clinical trial Modifiers for 2008 and forward include: Q0: Investigational clinical service provided in a clinical research study that is in an approved clinical research study Q1: Routine clinical service provided in a clinical research study that is in an approved clinical research study Page 1 of 8
b. Subject List required 1. Lists all subjects enrolled in the study, the dates of the visits, and exceptions to the Clinical Trial Master Matrix (Y or N). 2. Details of the exception will be captured on the Treatment Exceptions page of the workbook Note: The subject list shall be updated within one week of each clinical trial visit. c. Research Treatment Exceptions required 1. Lists each patient that has a treatment exception to report and provides a detailed account of the exception 2. This page will assist personnel during research of billing questions and satisfies regulatory requirements for documentation of deviations from the protocol d. Individual Subject Matrix optional 1. Only one study subject will be detailed on each matrix page 2. Multiple Individual Subject Matrix pages can be included in the workbook. The matrices listed above are located on the NHSSecure Drive and housed within the Clinical Trials folder. File Path structure. The Clinical Trials folder is divided into subfolders for each medical specialty (i.e. Cardiology, Urology, Radiation Oncology etc.). Each specialty folder is divided into Principal Investigator (PI) sub-folders. Each PI folder contains the matrices for their studies. File path: Clinical trials Main folder à Specialty Sub-Folder (i.e.: Cardiology, Hematology, Urology etc.) à PI Sub-Folder (i.e.: Smith, Jones, Einstein.etc.) à study matrix Example of file path for the matrix of a study would be as follows: L:\Clinical Trials\Internal Medicine\Einstein\ 000-07-FB 33-4444-5555-666 MXH-99-925- 0000 StudyME Naming convention for Clinical Trial Charge Matrices. Each matrix placed in the clinical trial subfolder shall be listed using the following naming convention: IRB number, Grant number, short study title Page 2 of 8
All Grant numbers must be referenced regardless of origin [Workbook Structure (WBS) #, Research Support Fund (RSF) #, and/or interdepartmental funding source]. The IRB and/or Grant numbers may not be known when the matrix is created. Pending IRB# and/or Pending Grant # may be inserted in the naming convention until such time as the numbers are assigned. If no Grant number will be assigned enter No Grant in the naming convention. Naming convention examples: 000-07-FB 33-4444-5555-666 MXH-99-925-0000 StudyME IRB # WBS # RSF # Study name Or Pending IRB No Grant StudyME IRB # No Grants Study name Revisions to the Clinical Trial Matrix In the event that the procedures and/or tests, that require technical and professional charges, are updated or changed after the workbook has been approved by the IRB and the CRFCS, do not delete or modify the original file. A copy of the file should be made and the changes made to the copy. A revision suffix should be appended to the original file name. The original file will reflect V1.0 superseded as the suffix and the revised copy will reflect V2.0 revised as the suffix to the naming convention. A note should also be entered into the comment section of the Clinical Trial Master Matrix page explaining when and why the matrix was revised. The CRFCS will be notified of the corrections/changes and will then move the superseded file to an archive folder to prevent inadvertent use. The revised matrix workbook should be routed back to the IRB for review and re-approval. Naming convention example: Original or Superseded matrix 000-07-FB 33-4444-5555-666 MXH-99-925-0000 StudyME V1.0 superseded IRB # WBS # RSF # Study name version # Page 3 of 8
New or Revised Matrix 000-07-FB 33-4444-5555-666 MXH-99-925-0000 StudyME V2.0 revised IRB # WBS # RSF # Study name version # Access to Matrices The CRFCS shall approve individual access to the clinical trial charge matrices and shall notify Information Technology Services (ITS) when the individual completes mandatory clinical research billing education so that access can be provided. (See paragraph 9). 3. Verification Table Update. After the IRB approves the clinical trial protocol, Sponsored Programs Administration shall send the WBS grant account number to the clinical research designee and the Clinical Research Center Manager so CRC personnel can place the WBS number in the CareCast Verification Table. The CRC shall place an asterisk (*) next to the coordinator s name in the Verification Table for Medicare qualifying trials. 4. Research Subject Informed Consent. The individual obtaining informed consent from the subject shall review the charges with the patient so that they understand how the charges will be billed and what charges they are or potentially may be responsible for paying. The research subjects shall be informed that they will be responsible for paying any balances due after insurance has paid for routine care. The original informed consent shall be placed in the research file. A copy of the consent shall be placed in the medical record, and a copy shall be provided to the research subject pursuant to IRB and hospital policies. a. Advance Beneficiary Notice Requirements for Research Subjects who are Medicare Beneficiaries. If the research subject is a Medicare beneficiary, and the clinical trial the subject is participating in does not meet the criteria for a Medicare qualifying trial (see Attachment 1; also, there is no * next to grant description in VT Table), then the individual obtaining informed consent must provide the research subject with an Advance Beneficiary Notice (ABN). The ABN is a written notice instructing the subject that Medicare will probably deny payment for that specific service or item; specifies the reason the provider expects Medicare to deny payment, and that the subject will be personally and fully responsible for payment if Medicare denies payment. The ABN provides the subject with the opportunity to refuse to receive the service or item. Page 4 of 8
See The Nebraska Medical Center Policy MI.15, Advance Beneficiary Notice (ABN) or UMA Policy CD01 for guidance on obtaining the ABN. The ABN Requirements flowchart at Attachment 2 provides additional information. Note: The research subject cannot be charged for any research-related items or services that Medicare does not cover if an ABN is not signed. 5. Creating Medical Record and Research Subject Grant Account. a. Creating Medical Record for New patient. If a research subject has not been registered in CareCast, complete the Research Participant Pre-Registration Form and submit it to The Nebraska Medical Center Access Services according to the guidelines below so a medical record can be established. b. Creating Research Subject Grant Account. The coordinator/designee may create their own research subject grant account or request that The Nebraska Medical Center Access Services create the account by providing them with a completed Research Participant Pre-registration form. c. The Nebraska Medical Center Access Services Guidelines i. Appointment scheduled more than 24 hours in advance: fax Research Participant Pre-Registration form to Access Services at 552-3267. Access Services will complete the registration process by 5:00 p.m. the day before the scheduled appointment. The coordinator can check CareCast to verify registration is complete and should call 552-3251 if data is not present. ii. Appointment scheduled less than 24 hours in advance: telephone Access Services representative to request registration assistance at 552-3251. Access Services will provide the caller with an estimate of when the registration services can be accommodated. Fax the Research Participant Pre-Registration form to Access Services at 552-3267. d. Creating Research Subject Grant Account. For coordinators/designees who wish to create their own research subject grant accounts in CareCast, the following procedures should be followed using the REG command: Account Type: S Account Subtype: R Service: O/P Source: 2 Start Date: Date the account is opened End Date: Enter projected end date (can be revised if necessary) Page 5 of 8
Location: Grant number; select the appropriate grant number from the Grant folder located in the VT Table in CareCast (Note: Do not free text grant number in this field) Presenting Diagnosis: Enter V70.7 and/or research Ordering Physician: Enter Insurance Plan Code: Code Short Title Long Title Description 617 GNTINTRSF grantinternalresearchfund Funded by Internal Research Funds 1018 GNTCMSQUAL grantcmsqualifying Qualifying Medicare Trial 1019 GNTCMSNOQUAL grantcmsnonqualifying Non-qualifying Medicare Trial Grant ID: Grant number; select the appropriate grant number from the Grant folder in CareCast (Note: Do not free text grant number in this field) Effective Date: Account start date (date grant effective for that patient) End Date: Blank Insured s Employer: Copy from patient Coordinator Name: Enter appropriate study coordinator Coordinator Phone Number: Enter study coordinator phone number Coordinator Zip Code: Enter the study coordinator campus zip code Guarantor: patient 6. Entering Clinical Trial Orders on Research Order Sheet. For all inpatients and outpatients, including clinics that utilize encounter forms, research orders shall be written on the Research Order Sheet (ORD-MR-0437) including the IRB number, grant account number and short study title. The following letters shall be placed next to each test and procedure to indicate how it shall be billed: a. G for tests/procedures billable to the grant account; b. RS for tests/procedures billable to either insurance or to the patient. List any special billing instructions, such as treatment of complications, in the Staff Notes section. A letter must be written next to all research orders. Please refer to the Clinical Charge Matrix located in the NHSSecure Drive Clinical Trials folder for assistance. Outpatient Research Orders. If the coordinator is placing the research orders into CareCast, he/she may write Patient on protocol # (insert IRB approval #) and study visit # in place of writing each test and procedure on the Research order form. However, if a different individual is placing the orders into CareCast, each test/procedure must be listed on the Research Order form. The ordering provider must authenticate (sign, date, time, CareCast #) the order(s) regardless of which method is used. Page 6 of 8
7. Entering Clinical Trial Orders into CareCast. a. Outpatients. The individual shall enter clinical trial orders into CareCast and select the correct account(s) to bill the charges for each research subject (see c. and d. below.) Account numbers for each research study are listed on the Research Order sheet and are also on the clinical trial master matrix located in the NHSSecure Drive Clinical Trials folder. b. Inpatients. The individual entering the clinical trial orders into CareCast must contact the CRC Research Billing Specialist at 559-8205 to have the research charges billable to the grant account moved from the insurance account to the grant account. c. Orders Placed on Grant Account. When orders are placed on the grant account, make sure the ordering physician is listed so that he/she receives the test results. d. Orders Placed on Insurance Account. On the order detail screen, in the Comments field, type indication for exam, test or procedure. Under diagnosis, write Research Encounter. These two fields must be completed. 8. Grant Account Technical Charge Review a. The Nebraska Medical Center Patient Financial Services (PFS) sends hard copies of the grant account charges to the Clinical Research Center monthly. b. The Research Billing Specialist sends hard copies to the appropriate coordinators/investigators for review. The coordinator/investigator shall compare actual charges with the Clinical Trial Charge Matrix to verify all charges are billed correctly. c. The coordinator highlights the charges that should be applied to the grant account and sends them back to the research billing specialist. d. The research billing specialist then applies the appropriate research discount and enters that into the billing system. e. Any routine medical charges found on grant accounts are transferred by the CRC Research Billing Specialist to the research subject s insurance account for third-party payor reimbursement and the UMA Business Service Center (BSC) is notified of the transfer when professional fees are involved. f. The bill is then returned to the coordinator with the discount. g. The coordinator is responsible for signing this copy and sending it to the Patient Financial Services (PFS) Support Manager. h. PFS puts it through the system so the money moves from the grant to the hospital. i. These charges will then show up on the ledgers that give an accounting of the grant account. j. Professional fees are not included in this bill. 9. Clinical Research Billing Education: All individuals responsible for placing clinical research orders and charging related costs shall complete mandatory clinical research billing education provided by the Clinical Research Center prior to beginning clinical trialrelated duties. Education in completion of the Clinical Trials Matrix Workbook is provided by Page 7 of 8
the Clinical Research Financial Compliance Specialist (CRFCS). Both phases of training must be completed prior to assignment of access to the NHSSecure drive and clinical trials folders. Additional training shall be provided as needed. 10. Review of Clinical Trial Grant Accounts. PIs or their designees shall close research subject grant accounts when the research subject is no longer participating in the clinical trial and all research-related charges have been billed. When the grant account for the overall clinical research trial has been closed, the PI/designee shall notify the CRC so the grant account number can be taken out of the VT Table in CareCast. a. Annual Review. PIs or their designees shall conduct an annual review of research subject enrollment in clinical trials at the same time as the required IRB annual review and close out grant accounts as necessary. i. Closing Individual Research Subject Grant Accounts. If the research subject is no longer an active participant in the clinical trial and all orders have been entered, the grant account shall be closed by the research coordinator by taking the following steps: Enter FINC in the command field and press enter Choose account to close Tab to the End Date field and enter date account closed Tab to Location field and choose Account Closed from the drop down box Tab to Insurance edit field and click Click on the review/update current guarantor box Press enter The guarantor screen will appear. Press enter The Insurance detail screen will appear Tab to Exp date and enter account close date and press enter. b. Research Subject Lists. PIs or their designees may obtain lists of all research subjects with open grant accounts in a specific clinical trial by contacting the IT system consultant at 559-8552. Created: July 1, 2006 Last Updated: March 11, 2008 Page 8 of 8