黑社区

Sponsored Projects Administration

PROCEDURES

Research at 黑社区 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 黑社区Health.

Research Staff Responsibilities:

1. Identifying Studies Requiring Epic Patient Participant Management:

a. 黑社区Health 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.

  • 黑社区Health 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.

b. Linked 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.)

Click Here to view a 60 second GIF showing how to link a patient to a study in Epic.

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 黑社区P clinics, do I need to link these patients in 黑社区P’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 黑社区P 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 黑社区P’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/Associate Research Visits while scheduling - Epic – This guidance document can be used by front desk staff for linking visit encounters to a study while scheduling visits, or during check in.

  • This document provides instruction on how people with registration/scheduling duties can link visits/visit encounters to research studies.
    • Often times visits get cancelled/rescheduled at a later date. It is highly recommended for the researchers to link upcoming visits via the report noted below to ensure research visit charges are not billed to patient/patient’s insurance.
  • 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

  • : This document outlines the regulation requiring the NCT number on CMS claims.
  • This document provides guidance for CMS billing related to the NCT number requirement.
  • This website provides additional information regarding NCT number