Budget and Billing Workbook

What is the Budget and Billing Workbook (commonly referred to as the Workbook)?

  • Excel workbook used for clinical research studies with patient care services to designate and document all hospital fees as either (1) billable to the research study account, and thus, paid for by the sponsor, OR (2) billable to the patient/insurance
  • One of the required Minimum Documents submitted  to initiate the study set-up process for an Industry-Sponsored Clinical Trial (CT)
  • CONFIDENTIAL internal document not shared with sponsors
  • Note that Lucille Packard Children’s Hospital (LPCH) and Stanford Health Care (SHC) have separate versions of the workbook
     

In addition, the Workbook provides other benefits:

  • Prevents major compliance issues like double-billing (i.e. billing both the sponsor and a patient/patient’s insurance for the same item)
  • Helps study team accurately manage study patient charges, as per contract, from enrollment through closeout
  • Ensures Medicare Clinical Trial Policies are followed

 

The Clinical Trial Research Management Group (CT RMG) requires a complete Workbook prior to budget development, contract signature, study account setup, and patient enrollment.

How to complete the Budget and Billing Workbook (commonly referred to as the Workbook)

The study team completes the Workbook for clinical research studies with patient care services provided by either Stanford Hospital & Clinics (SHC) or Lucile Packard Children’s Hospital (LPCH).   Each hospital has a specific version of the Workbook that captures the costs of services performed at the respective hospitals, regardless of patient age.  Both Workbooks are structured the same, however, they have pricing and coding information specific to the location where the patient care services will be performed.

The Workbook has several labeled tabs (labels shown below, highlighted in yellow). 

Tabs at the bottom can be used to navigate the Budget and Billing Workbook.

Each tab serves a different purpose in the budget and billing process.  Below is a brief description of each tab or worksheet.

Tab 1 - Instructions

Comprehensive instructions on how to complete the Workbook and a great resource when questions arise!

Tab 2 - Research Participant Services (RPS) Form

The RPS Form provides key billing information to the hospital Patient Financial Services (PFS):

  • Basic information about the study
  • Whether the study meets Medicare CT Policy criteria
  • Identifies the patient care services that should be billed to the study account as a research and not to the patient/patient’s insurance as standard of care
     

Step 1:   Provide basic study information in the upper section of the form.  For example, click on the Medicare Determination question hyperlink to be taken to the decision tree tool to determine if this is a Medicare National Coverage Determination (NCD) Qualifying Study.  If uncertain, discuss with your RMG institutional official during the budget development process.

Portion of the RPS form for entering basic information. 

Step 2: The RPS form lists five categories of services offered by SHC or LPCH:  Laboratory Testing, Technical Fees, Radiology, Professional Fees and Supply Costs.  Costs included on the RPS form will be billed to the study account, not to the patient or to the patient’s insurance.

  • List all billable research-related clinical service items in the relevant section.
  • Common services are located in the drop-down menus.  When selecting services from the drop-down menu, codes and fees will automatically populate
  • Based on review of protocol Schedule of Events, enter Occurrences per Participant per Study Period.
  • When the drop-down menu does not contain an item, follow directions on the Instructions tab to locate codes and prices and enter them into the appropriate section on a “blank row.”   

Occurences per participant per study column, second from the right.

Step 3: Add details for other services associated with the study, but not chargeable through SHC or LPCH Patient Financial Services.  Examples include pharmacy fees, Lucas Center Fees, CTRU Fees, etc.

Step 4: Add clinical service items that are not performed on every patient based on the protocol (e.g., DXA scan only required for women of a certain age, or when a baseline visit requires an MRI and sponsor will accept a routine care MRI if completed in the past 3 months).

Tab 3: Routine Care Services Form

The study team has deemed items on this tab as routine care, chargeable to the patient/patient’s insurance.  The top section of this tab will auto-populate from the RPS Form.

  • Using the protocol’s Schedule of Events as a reference, list in the Service Description section all clinical services to be charged to the study subject’s insurance as part of routine care
  • Enter number of Occurrences per Participant per Study Period
  • Use Comments section as required to provide clarification, especially if the same service is also listed on the RPS form (e.g., if “clinic visits” are listed on the RPS Form and on the Routine Care form, indicate the number under Occurrences per Participant and list the associated time-points under comments such as “6, 12, 24, and 36 months”).
  • If appropriate, use a generic statement: “All clinical care in this study is billed to the patient,” or “No clinical care in this study will be billed to the patient,” or “Clinical management of surgical procedure.

Sample Routine Care Services Form

Tab 4 - Internal Budget Tab

The CT RPM adds the internal budget for the study on this tab.  This tab shows a complete picture of Stanford’s internal costs, including personnel costs, clinical care items, start-up, invoiceable items, etc.”

Tab 5 - Study Account Request Form

After budget has been finalized and the contract executed, a Notice of Award is issued and a hospital account is set-up.  Note the hospital account requires a University PTA.  Please refer to Hospital Accounts  for more information.

Tab 6 - Study Enrollment Form

Patient Financial Services requires patient Medical Record Number (MRN) and effective dates to accurately bill patient services to the study account or to the patient/patient’s insurance.  

All Other Tabs

RMG utilizes the remaining tabs within the workbook for RMG processes.  No action is required by the study team on these tabs.