Budget and Billing Workbooks
SHC Modified Workbook and LPCH Budget and Billing Workbook
Please note that Lucille Packard Children’s Hospital (LPCH) and Stanford Health Care (SHC) use different workbooks. Each hospital has a specific version of the Workbook that captures the costs of services performed at the respective hospital, regardless of patient age. Each workbook has pricing and coding information specific to the location where the patient care services will be performed.
What is the Budget and Billing Workbook (commonly referred to as the Workbook)?
- An Excel workbook used by hospital's Patient Financial Services (PFS) for clinical research studies with patient care services to process 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
- Workbooks are used by CT RPMs to estimate hospital costs within Stanford's per patient budget
- One of the required Minimum Documents to initiate the study set-up process for an Industry-Sponsored Clinical Trial (CT)
- CONFIDENTIAL internal document not shared with sponsors
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
Stanford Internal Policies:
- Spectrum Research Budgeting and the Workbook Process class
- Updated Coverage Analysis Resources to be posted soon
Who Completes the Worksheets within “Workbook” for Industry-Sponsored Clinical Trials?
|Workbook template used:||
SHC Modified Workbook
Used for all NEW studies with clinical services rendered at SHC Workbook includes formal Coverage Analysis (CA). PI’s approval of CA is required.
LPCH budget and billing workbook
Always work with the current workbook downloaded from Spectrum website.
IMPORTANT: For studies that will enroll both pediatric subjects with clinical services required at LPCH and adult subjects with clinical services required at SHC, study will require Coverage Analysis (CA) and it will be used to prepare to the LPCH workbook.
|Coverage Memo||Huron (SHC Consultants)||Not applicable|
|Billing Grid||Huron (SHC Consultants)||Not applicable|
|RPS Form||Huron (SHC Consultants)||Study Team|
|Routine Care Form||Not applicable – see details within Billing Grid||Study Team|
|Study Account Request Form||For all studies, completed by Study Team post-Award and Patient Financial Services.(See Instructions Tab in Workbook).||For all studies, completed by Study Team post-Award and Patient Financial Services.(See Instructions Tab in Workbook).|
|Study Enrollment Form||
For all studies, top section is auto-populated by RPS form. Form updated as needed by study team post-Award. (See Instructions Tab in Workbook).
|For all studies, top section is auto-populated by RPS form. Form updated as needed by study team post-Award. (See Instructions Tab in Workbook).|
|CITI Cert Form||For all studies, completed by CT RPM.||For all studies, completed by CT RPM.|
How to complete the LPCH Budget and Billing Workbook (commonly referred to as the Workbook)
The Workbooks have several labeled tabs:
Each tab serves a different purpose in the budget and billing process. Below is a brief description of each tab or worksheet.
Tab - Instructions
Comprehensive instructions on how to complete the Workbook and a great resource when questions arise!
Tab - 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.
Step 2: The RPS form lists four categories of services offered by LPCH: Laboratory Testing, Technical Fees (Imaging, Respiratory Therapy, Electrocardiology, Anesthesiology), 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.”
Step 3: Add details for other services associated with the study, but not chargeable through 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: 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.”
Tab - 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 research personnel costs, hospital costs (clinical care items), start-up costs, invoiceable items, etc.”
Tab - 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 - 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.