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PROCEDURES

Research at UT Health often takes place in conjunction with routine clinical care of patients, and it is necessary to ensure that billing for both routine and research services/items is handled appropriately. The four component to ensuring these charges are handled appropriately are:

  1. Coverage Analysis
  2. Patient registration/Patient Linking
  3. Research Visit Scheduling/Linking
  4. Research Visit Charge Review

All applicable clinical research study visits that meet the criteria outlined in HOOP 214 will be scheduled in Epic and/or applicable billing systems. It is the responsibility of each department to ensure clinical research patients are registered and linked to the study and that research visits are linked to the study.

The below information provides an overview of the clinical research scheduling and billing processes and procedures at UTHealth.

Research Staff Responsibilities:

1. Identifying Studies Requiring Epic Patient Participant Management:

a. UTHealth ensures a coverage analysis created for all applicable clinical studies. The coverage analysis outlines the services billable to the research payor or to the insurance payors. Click here for more information about coverage analysis. .

b. All clinical studies have CA records in START. All clinical studies requiring patient participant management in Epic are notated with the status: “CA Approved- Epic.

  • UTHealth ensures all applicable studies are loaded into Epic for linking.

2. Patient Registration and Linking :

a. MRN: All research participants enrolled in an applicable clinical research study must have a medical record number (MRN) in Epic.

bLinked to study: All research participants enrolled in an applicable clinical research study must be linked/associated to the study in Epic. It is the department’s responsibility to ensure all research staff are linking patients in a timely manner. (24-48 hours is best practice.)

        Epic Tip Sheet-Study Coordinator Guide provides guidance on linking visits to research studies. It is located on the SPA website under       
       “Tools & Resources”/” Forms & Templates

c. Affiliate Hospitals and Clinics: All research participants enrolled onto clinical research study that involves services or procedures at either Memorial  Herman Hospital or Harris Health must submit a “Patient Registration Form” as applicable.

  • MHH Patient registration form and Harris Health patient registration form can be found on the SPA website under

               “Tools & Resources”/”Forms & Templates.

               *Question- For studies that are not conducted in UTP clinics, do I need to link these patients in UTP’s Epic?

               * Answer-Yes, if the study is in Epic, then you are required to link all patients enrolled onto the study in Epic. Simply because a study is 
                  conducted outside of UTP clinics does not automatically exempt a study from research patient management in Epic. If the CA AGT record  
                 status  is “CA Approved- Epic then it has been determined that professional fees will be entered into UTP’s Epic, and therefore patient
                 management in Epic is required.


3. Research Visit Scheduling/ Linking:

All research visits are required to be linked to the study in Epic.(This ensures the visit encounter charges are automatically routed to Epic’s research billing review work queue.) All visit types can be linked to a study. (There is no “Research Visit” type.)

a. How to Link Visits to Research Studies: 

  • Link at time of scheduling visit
  • Link visits that have already been scheduled by utilizing research reports 

               Epic Tip Sheet-Study Coordinator Guide provides guidance on linking visits to research studies. It is located on the SPA website under 
               “Tools & Resources”/”Forms &Templates”.  


4. Research Visit Charge Review:

a. All charges entered into encounters that are linked to research studies will be routed to Research billing review work queue. It is the study team’s responsibility to ensure charges for each visit are reviewed, corrected if necessary, and released.

b. Refer to the coverage analysis to ensure the charges are accurately filed into one of the following buckets:

  • Research Related – Bill to Study
  • Research Related-Routine care bill to Patient/Patient’s insurance

                   - Epic will include NCT# and research codes as applicable

  • Not Related to Study

Epic Tip Sheet-Study Coordinator Guide provides guidance on reviewing research visit charges. It is located on the SPA website under “Tools & Resources”/”Forms & Templates”.  


REFERENCES/RESOURCES