February 11, 2016. Budgets for Industry-sponsored studies. Presented by Julie Calahan, Budget Analyst, Health System Contracts.
Effective financial management of clinical trials requires integration of the essential elements that include coverage analysis, budgets, invoicing and accounts receivable, effective separation of billing streams by payor and billing reconciliation. For more information and training, please contact:
The National Medicare Clinical Trial Policy (formerly known as National Coverage Determination 310.1) necessitates a priori delineation of what clinical trial services/procedures can be billed to Medicare, and which could only be billed to the study. Such delineation can be expressed in a Coverage Analysis. The Coverage Analysis consists of two documents, a QCT (Qualifying Clinical Trial) Form and a Billing Grid (template, example)
QCT form is available in the paper form for preliminary Coverage Analysis. The final QCT form must be documented in the Bridge and signed by the PI electronically.
Billing Grid is a spreadsheet. Initially, the Billing Grid is built based on the principles set by the National Clinical Trials Policy. For industry trials, the grid is often adjusted based on the provisions of the Clinical Trial Agreement. Upon completion the final Billing Grid is signed by the PI and uploaded into the Bridge .
Per P&P 2317 Coverage Analysis is mandatory for all studies that have one of the following characteristics:
- Utilize a drug or device;
- Involve any charge or billing component (including billing to a third-party insurance, study sponsor, or patient);
- Include, as part of their protocol, any clinical intervention, including the invasion of any participant (control or subject’s) body cavity (e.g. blood draw) when such an intervention takes place within a UC Davis Medical Center licensed facility.
Device studies must undergo additional review by the Noridian, the California CMS intermediary. Noridian determines Medicare coverage of devices based on which category the FDA assigns the device. Expanded coverage may also be approved for routine and research services within a device study.
This device flow chart details the process for filing for Medicare Approval of the Devices. Please also see Noridian website:
UCDMC P&P 2317 DOCUMENTATION OF RESEARCH STUIDES AND PARTICIPANTS IN THE BRIDGE AND ELECTRONIC MEDICAL RECORD SYSTEMS (PDF)
CTSC SOP #4 Coverage Analysis (PDF)
CTSC SOP#13 CREATE AND MANAGE RESEARCH STUDIES IN EMR/EPIC (PDF)
UC Davis Clinical Research Guidebook
The key Federal law: National Medicare Clinical Trial Policy (also called National Medicare Coverage Determination NCD 310.1)
California Coverage Laws: Noridian JE Part A and Part B Local Coverage Policies (Medical Policies)
California Law SB37
Medicare Coverage Database (database of Medicare Policies)
Medicare Benefit Manual (includes information about services that are a benefit of Medicare).
Managed Care Benefit Manual (includes information about Medicare Advantage Patients).
IDE Approval Forms (Noridian IDE Policy: https://med.noridianmedicare.com/web/jea/policies)California Law SB37
Excellent training presentations could be found in Training Archives
Questions? Contact Suzan Bruce, Clinical Research Billing Analyst, CTSC: email@example.com
Internal Budget identifies study costs based on labor costs and research rates for procedures. This form derives procedure information from Coverage Analysis and Billing Grid.
External budgets are negotiated with Industry Sponsors based on the Fair Market Value. The external budget should cover costs included in the internal budget. Formats for sponsor budgets vary, as each sponsor requires their own format. External budgets are often expressed as "invoiceables" and "per patient cost."
Unified Budget Template (UBT) is the form used to prepare internal budgets for all industry-sponsored studies. CTSC SOP#8, CTSC SOP#9 and Clinical Research Guidebook detail preparation and approval of Industry-initiated and sponsored study budgets.
- UBT template (excel) from the Health System Contracts (4/2013)
- UBT template (excel) from CTSC Clinical Trials Resource Group - unlocked (12/2015)
Use Epic Cost Query Tool to find the costs for hospital procedures and services (i.e. X-rays, CBC, Office Visits). The research costs vary based on location within the UCDMC. The Research costs may change several times a year, therefore, for multi-year trials, use 10% inflation per year for procedure costs.
Epic Cost Query Tool with rates applicable through July, August, September and October 2014
Epic Cost Query Tool with rates applicable from November 1, 2014. Updated 1/26/2015
Epic Cost Query Tool (2016) with rates applicable from January 1, 2016. Updated 1/25/2016
If the sponsor questions the start up costs, utilize "Dear Sponsor" letter to explain how some of these costs are derived
CTSC SOP #4 Coverage Analysis
CTSC SOP #5 Budget Approval for Industry Initiated Studies
CTSC SOP #9 Completing an Internal Industry-Sponsored Clinical Trial Budget
UC Davis Clinical Research Guidebook
Questions? Contact Julie Calahan, Budget Analyst, HS Contracts: firstname.lastname@example.org
Per Policy and Procedure 2317, all research studies (expedited and fully reviewed) that meet one of the following criteria must be documented in the Bridge and Epic and the study participants (subjects and controls) must also be associated in EPIC:
- All Studies that utilize a drug or device;
- All studies that involve any charge or billing component (including billing to a third party payor insurance, study sponsor, or patient)
- All studies that include, as part of their protocol, any clinical intervention, including the invasion of any participant (control or subject’s) body cavity (e.g., blood draw) when such an invasion takes place within a UC Davis Medical Center licensed facility.
Upon review and approval of the UCDHS Compliance Office, some exceptions may apply.
CTSC SOP#13 takes users through the steps necessary to complete the Bridge information. Once this information is complete, the study is transferred into the EMR.
1. Send request and sign the User Agreement for the Bridge: https://ctscassist.ucdmc.ucdavis.edu/redcap/surveys/?s=INFGig
2. Login into the Bridge (https://ctscassist.ucdmc.ucdavis.edu/redcap/) using Kerberos password.
Blinded studies may still use paper Lab Sample Requisition Forms.
To create your study in Epic, follow the steps below.
1. The Bridge is a database that houses the information needed to create a research study record in the EMR. A Kerberos ID and password are required to access the Bridge data.
- Send request and sign the User Agreement for the Bridge
- Login into the Bridge (https://ctscassist.ucdmc.ucdavis.edu/redcap/) using Kerberos password.
Follow the procedures outlined in CTSC SOP#13 to annotate the required information in the Bridge. Information required to complete a record:
- PI Provider ID (drop down list)
- Coordinator Name
- Coordinator PPSID (Employee #)
- Department (drop down list)
- Study Short name
- NCT # (ClinicalTrials.gov), mandatory requirement for claims
- Does the study have patient care services billed in UC Davis Health System?
- Coverage Analysis questions (many)
- Determination if this is a qualifying clinical trial
- Physician/coordinator attestation
- Upload Billing Grid (if any)
- DaFIS Number,
- Valid (start) dates and Valid (finish) dates
24-48 hours after clicking “Ready to Upload” the updated information will be displayed in the EMR
2. Study Subjects (including controls), their Encounters and Orders must to be associated with the Research Study in EMR. Such association achieves the following:
- Creates a Bill Hold to separate billing streams to Study Accounts and Insurance Accounts
- Identifies all research study subjects (controls included)
- Tracks study procedures and services for Health Information Management Disclosures
- Creates notification for billers to issue correct claims
The basic information about the study is transferred from the Bridge to the EMR. Once the study is in EMR it needs to be further annotated.
Starting July 2014, the Bridge supplants the paper-based “Bulk Account Application Form” for most studies. A “Dummy Patient Record” (an equivalent of the Bulk Account, now called “Research Account”) is generated by using EMR functions. To create a Dummy Patient Record, the tab “Billing Setup” in the Research Study Record must be completed.
For all studies, independent of the payor type, the study coordinator must click on “Create Records Necessary for Billing.” This generates “dummy patient record” and initiates tracking of research-related charges.
The ”dummy patient record” must be generated in EMR for each study whether or not billing to a research study is actually required.
3. Once the charges are posted, the research team reviews the charges in the "Research Patients needing Billing Review" report in EMR, and makes necessary adjustments based on the Coverage Analysis Billing Grid.
Research Billing Review” Reports are used to verify that technical and professional charges for research patients are being routed to the correct account. The coordinator selects a patient from the report and clicks “Billing Review” to review the charges. If a charge was incorrectly assigned to insurance or the study, this can be corrected using the “Research Correction” option. In addition, Restrictions in this report could be changed to show previously completed charges.
Important: The 4 calendar day window for charge review is the billing system’s default. This includes holidays and weekends. The study staff has 4 days from the time of discharge to provide the review of both Inpatient Charges and Outpatient Charges. After the 4-day window closes, the charges are reported to the Department Managers as outstanding
4. The principal investigator or CRC should review the research accounts on a monthly basis to ensure that all charges are appropriate and no charges are missing or duplicated. If the errors are identified after the claims are issued,contact PFS and PBG billing adjustments. These include charges posted in error, wrong bulk accounts, charges going to insurance instead going to bulk.
UCDMC P&P 2317 DOCUMENTATION OF RESEARCH STUIDES AND PARTICIPANTS IN THE BRIDGE AND ELECTRONIC MEDICAL RECORD SYSTEMS
UCDMC P&P 1815 Establishing a Bulk Account
CTSC SOP#13 CREATE AND MANAGE RESEARCH STUDIES IN EMR/EPIC
UC Davis Clinical Research Guidebook, Chapter 8
EMR Research Website: Quick Start Up Guide and FAQs
For policy issues contact Sharalyn Reed, Deputy Compliance Officer, HS Compliance, email@example.com
For Bridge, contact Suzan Bruce, Clinical Research Coder, firstname.lastname@example.org
For EMR related questions, contact William Kjar, Information Technology Education Training Analyst, email@example.com
For Patient Financial Services, contact Helen Sundet, Analyst IV, firstname.lastname@example.org
Monthly Research Account statements are now available in the Excel format on Report2Web (R2W). The statements are uploaded monthly into a study specific folder (by IRB number). Statements show the charges posted for the past month with the appropriate research discounts. They also include patients MR#s, date of service, procedure code and procedure name. Only the individuals listed as Coordinators in the Bridge are able to view and download the statements from R2W, and only for the studies they are linked to.
The principal investigator or CRC should review the research accounts on a monthly basis to ensure that all charges are appropriate and no charges are missing or duplicated. Research billing corrections may also be required as a result of a research billing review conducted by Compliance.
During the study the Study Coordinator (CRC) updates enrollment log and individual schedule of events for each study week. The information on the schedule of events shows actual visit dates and has a notation what services and procedures were completed during that visit. CTSC SOP #7 provides step-by-step process and excellent examples of enrollment logs.
A financial analyst uses this information to convert completed visits into Accounts Receivables by using the contracted amounts per visit/procedure. All costs for rescheduled visits, delayed procedures, adverse events and any other “invoiceable” items are also captured at this time. The Financial Analyst enters invoices into DaFIS-ARIN (Accounts Receivable Invoice). Simultaneously, the paper/electonic invoice is sent to the industry sponsor using the letter format with DaFIS document number referenced. CRCs track the ARs on the spreadsheet and reconciles with cash received from the sponsor.
A PI must dedicate a minimum of 1% effort to a clinical trial in PRDRUG fund category (industry-sponsored clinical trial). This effort can either be cost shared or directly charged to the trial. "Cost shared” means committed time that is paid by sources other than the extramurally funded project; “direct charged” means committed time that is paid (i.e. directly charged) by the extramurally funded project. At the end of the trial, a review must be completed to ensure full project costing before a residual balance may be transferred to a R & E account. Follow CTSC SOP#7 and CTSC SOP#9 to calculate PI effort and record it in the Effort Reporting System and in DaFIS.
UCDMC P&P 1802 Billing and Collection of Contract Account Receivable
UCDMC P&P 1816 Department Financial Administrative Controls and Separation of Duties
CTSC SOP#7 Financial oversight of clinical trials
CTSC SOP#9 Principal Investigator Effort Reporting