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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:

All applicable clinical research study visits that meet the criteria outlined in HOOP 214 will be scheduled in GE Centricity and/or applicable billing systems. It is the responsibility of each department to ensure clinical research patients are registered and scheduled using the appropriate appointment type and in the appropriate schedule.

The below information provides an overview of the clinical research scheduling and billing processes and procedures at UTHealth. For a more detailed description, please review the Registration, Scheduling, and Charge Entry Policy. This policy outlines the responsible areas involved with research, registration and scheduling processes for clinical research patients.

Research Staff Responsibilities:

1. Identifying Applicable Clinical Research Studies:

a. Departments must perform a coverage analysis on all studies. The coverage analysis will outline the services billable to the research payor or to the insurance payors. Click here for more information about coverage analysis.


2. Patient Registration:

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

b. Research Registration/Research Flag: All patients enrolled in an applicable clinical research study must be notated as a “Research Participant” in GE and Allscripts

  • Click here for directions on how to complete “Research Participant” registration in GE/Allscripts

c.EMR Documentation: All research participants enrolled in an applicable clinical research study must have documentation of research study participation in medical records (Allscripts). (Click here for “Research EMR Documentation and Access Guidance” document.) Informed consent form must be uploaded as part of the patient’s medical record.

Research documentation note requirements:

  • Study name
  • Sponsor's Study protocol number
  • PI Name
  • Research contact name/phone
  • After hours contact name/phone
  • Date Consent signed
  • Expected completion date
  • Optional--Comments (include any possible drug reactions, etc.)

d. Case set up: “Case” set up will be required for all patients enrolled onto a study in which the conduct of the study will generate charges in the UTHealth billing system (GE Centricity) that are to be paid for by the research payor. (This information will be identified during the coverage analysis process. click here for coverage analysis details.).

A quick way to check if Case set up is needed, is to look at the coverage analysis. If any items are marked as “RES” a Case set up is needed for each patient enrolled onto the study.

Charges generated in GE Centricity that should be billed to the research payor are:

  • Services or procedures performed for research purposes only (These services or procedures would not have been performed as part of normal routine medical care.)
  • Services or procedures performed as part of routine medical care but offered to be paid for by the sponsor.
  • Services or procedures performed as part of routine medical care but offered for free in the informed consent document.

To request a “Case” to be set up on the patient’s account, complete the Case Set up request form and email it to Crf@uth.tmc.edu .

e. 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.Click here for MHH Patient registration form and click here for Harris Health patient registration form.


3. Research Visits:

a. Appointment Types: Patients scheduled in the GE Centricity system for research will use the following appointment types.

  • RES: Research appointment type identifies billable services payable by the research payor.
  • SOC: Standard of Care appointment type identifies billable services payable by the insurance payor. The charges will require the NCT number and applicable research codes and modifiers to be added to the insurance claims as required by governing regulations and policies.
  • Visit including routine and research services: If a single visit includes both routine services and research specific services, then the visit should be scheduled twice-one appointment with the designated research appointment type (RES) and one for the routine care services (SOC).

b. Scheduling Research Visits: All research visits to a UT Health facility or interpreted by a UT physician (i.e. Radiology, Anesthesia, and Cardiology) will be scheduled within GE Centricity.  There are multiple combinations for scheduling research appointments; please review the Registration, Scheduling, and Charge Entry Policy for details.

  • UTHealth research staff who do not have access to schedule visits in GE Centricity, should utilize the “Study Visit Request” template to communicate study visit information to schedulers.

Click here for Call Center “Study Visit Request “email template

Click here for General “Study Visit Request “email template.


4. Charge Entry Process for Research Visits:

a. Clinical Research Charge Document log:   (click here for charge document log.)

The PI is responsible for ensuring charges for the research visits are properly billed.

Clinic visits and professional fees submitted for charge entry and coding will be submitted by the Principal Investigator or designee of the clinical trial. The charges can be submitted in three forms of entry:

  1. Clinical Research Charge Document Log: The most efficient way to communicate clinical charges that are part of a clinical research study to the billing staff is to utilize the “Clinical Research Charge Document Log” (CRCDL)
  • Email or deliver completed CRCDL to billing manager/billing staff prior to or immediately after each study visit.
  • Study Visit Templates- Best practice is to create a CRCDL template for each study visit as soon as the coverage analysis is approved.
  • The CRCDL should match the Coverage analysis information exactly.
  1. Charges entered from Allscripts through MD Charge
  • Providers will enter the charges electronically in Allscripts. These charges will transfer into TES with the appropriate appointment indicators.
  • The appointment types RES and /or SOC must be utilized to ensure proper disposition of charges.
  1. Charge Document from the clinic for Routine Cost and Services.
  • The appointment type SOC must be utilized to ensure proper disposition of charges.

REFERENCES/RESOURCES


APPLICABLE REGULATIONS

Refer to the following billing guidelines for additional information:

  1. Medicare Policies and Guidelines
  2. Clinicaltrials.gov
  3. United Healthcare Policies and Guidelines
    • Clinical Trials
    • Aetna Policies and Guidelines
    •  Blue Cross Blue Shield Policies and Guidelines