1. SCCA Research Revenue Cycle From Set Up to Invoice Orientation for New Research Study Staff

2. Training Objectives Understand Key Concepts
Complexity of processes
Patient-Billable and Study-Billable services
Studies in Epic vs Studies outside of Epic
SCCA Research Revenue Cycle
Milestones
Forms/Processes
Roles and Responsibilities
Websites and Contacts
Confidential

3. Getting Started Charge Capture and Compliant Billing
Orders and Requisitions
Fee Sheets and Checklists
Medicare Clinical Trials Policy
UW Medicine
Policies 01 and 03
UW Medicine Effort Policy
Charge Level indications of research-related activities
Visit Level direction of research-related activities
Study and Participant Level
- Billing Documentation
- Participant registration
Confidential

4. Complexity Many Systems contribute information to “Research Billing”
Many Processes/Forms feed information to Systems
ORCA
Sunquest
LV+
Billing Grid
Epic Billing
Powerpath
Synergy
Requisition
SRO
Radiology Order
Pharmnet/
Pyxis
Mosaiq
PATS
RIS
Epic Charge Entry
Epic
HEMM
Confidential

5. Patient-billable/Study-billable
Both need to be understood and communicated for compliant billing
Patient-billed in error - High risk to SCCA and study
Potential for ‘double-dipping’ by study
Study services paid by sponsor AND paid by third party in error
Non-compliant to CMS’s Clinical Trials Policy
Study-billed in error – Lower risk to SCCA, but leads to rework by study staff and Revenue Cycle staff
Confidential

6. Studies in Epic vs Studies outside of Epic
Work is being done to bring all studies with billable components into Epic
Studies in Epic
Currently limited to studies with a study-billable component
Epic allows for better visibility to the patient for scheduling, charge capture and billing
Studies not in Epic
Studies with ‘bill all to patient’ services
Billing is highly dependent upon PATS entries and data flows that in turn drive Epic entries.
Confidential

7. Research Revenue Cycle
Production of Bills for Participants
Production of Invoices to studies
Correction of misrouted charges per Billing Documents
Production of Billing Documents
CPTs for study-related services
Pricing for study–related services
Study Set-Up
Participant Identification
Scheduling
Charge Capture
Monitoring/
Charge Review
Billing/Invoicing/
Corrections
Associate patient to study/studies in Epic
PATS enrollment information triggers Care Plan and Alert for billing
Referral for Financial Clearance (participant)
Link visit to study
Referral for Financial Clearance (services)
Forms (SRO, Requisitions)
Review charges against Billing Documents
Root cause analysis
Correction of charges pre-invoicing
Notification of Charging Systems
Supply Sheet
Anticipated Services Checklist
Provider Documentation for Coding
Confidential

8. Study Set-Up
Revenue Cycle is involved with the following activities at time of study set-up
Helps inform study staff of any special needs or watch points (CTI)
Facilitates set-up of services that happen at SCCA locations
Coding – CPT codes for services indicated by the protocol
Pricing – study pricing for study-billable services indicated by the protocol
Confidential

9. Set-Up Pricing - SCCA Research Fee Schedule
SCCA’s Research Fee Schedule
Provides price certainty for clinical trials
Provides consistent methodology for setting research prices
How are SCCA Research Fee Schedule prices set?
Cost recovery based on SCCA’s Medicare Cost Report
Factors SCCA’s direct and indirect costs of performing the service
When do prices/quotes change?
Research Fee schedule is a rolling three year quote structure
Each fiscal year the fee schedule is evaluated and an additional year is added to the schedule once the prior year expires
Fiscal year dates from July 1st – June 30th

10. Study Set-Up - Study Accounts
A study account is created via the set-up process
Helps ensures proper direction of patient or study-billable research-related charges
Account name in Epic begins with “RRR,”
The clinical trial is registered and assigned an Epic Study Code by CRBB
Current state: multiple institution-specific study codes – one for each site providing research services with general format R* (Ex: RS )
R for ‘research’
* = S, U or H to designate the site of the services (S=SCCA (including SCCA at NWH and Evergreen), U=UWMC (including SCCA beds on U 8NE), H=Harborview) – NEW – RG study codes for new studies (since 5/14) allow for multiple service areas. Plans to transition fully to RG over time.
Numeric portion is specific to the division, year of inception and serial number within the year
Used on forms to designate the study for activities of ordering, scheduling, accessioning and charge capture within Epic and the ancillary systems
Patients must be associated with the study account in Epic prior to scheduling research-related services

11. Financial Clearance of Participants
Coordinators request patient-level financial clearance by SCCA using Epic referrals prior to enrollment
Checks that the patient’s insurance allows participation in Clinical Trials
Helps ensure that protocol-specific patient-billable services will be paid for by the insurance company
Study documents may be provided to the payor for evaluation
Denials can be appealed
Work managed by SCCA Financial Clearance
Confidential

12. Participant Linking in Epic
Timely participant-to-study association in Epic is extremely important for accurate and compliant billing
Allows linking of participant’s visits to the study
Generates notification to study staff of inpatient or ED admissions
Provides general indicator for billing offices
Key Elements of patient-to-study association in Epic
Status – describes where the participant is in the billing flow
Active Start Date – describes the first date of research-related, patient or study-billable activity
Active End Date – describes the last date of research-related, patient or study-billable activity
Confidential

13. Participant Linking outside of Epic
Work is being done to bring all studies with patient-billable services into Epic
For studies not yet in Epic, PATS entries are the basis for compliant billing and clinical documentation
Key Elements of patient-to-study association in PATS
Enrolled date entry in PATS
Triggers the Research Care Plan and the Research Alert in ORCA
Triggers Epic Billing Alert at SCCA, UW Medicine and UWP
Billing End Date in PATS (last date of patient or study billable, research-related services)
Triggers the removal of the Epic Billing Alert that is used to aid in billing at SCCA, UW Medicine and UWP
Confidential

14. Charge Modifiers for Research

15. Research Visit Paperwork
Various forms are used to designate research study related services and items to separate systems/workflows
Scheduling Request Orders (SRO) - scheduling needs related to research
Pre-printed SRO’s are helpful
To initiate pre-printed SRO process contact the Research Implementation Office
Split Supply sheets (Infusion, Procedures) - study vs patient-billable supplies
To initiate pre-printed Split Supply sheets, contact Material Management
Lab Orders and Requisitions – directs lab-related activities in Epic and other systems
The Special Instructions or “inner note” outlines what charges are to be billed to research. This information is printed on requisitions sent to the laboratory prior to the scheduled appointment
Purple Requisitions used for samples that the study will handle and route to an offsite lab for processing
Radiology Order Form - specifically for scanning services
Anticipated Research Services Checklist – provides guidance for coders working to capture charges from ORCA documentation
Confidential

16. Anticipated Research Services Checklist
Supports all service areas except Profees, Laboratory and Radiology
Submitted via to SCCA Research Coding Team at:
Used to designate services anticipated for the visit that are research-related
Examples:
MA assisted EKGs
Oral Chemo Administration
Blood Draws
Conscious Sedation
Coding will NOT code charges from the Checklist. Services must be documented in ORCA by the providers.
Confidential

17. Roles and Responsibilities
Study Coordinator/Study Team
SCCA Scheduler/Team Coordinator
SCCA Clinical Research Billing
Analysts
Trainer
SCCA Research EAP Coordinator
SCCA Research Invoicing
SCCA Integrity/Compliance
Confidential

18. Role of Study Coordinator/Study Team
Contacts the SCCA Research Implementation Office (RIO) for new study implementation
Research Price Quotes are requested and provided during this process
Enters and maintains participant information
Epic referral to begin process of Clinical Trial Financial Clearance prior to enrollment
Epic “Research Studies” study-to-patient associations of consented participants
PATS accrual information for consented and enrolled patients
Facilitates orders, requisitions and other forms for research/clinical services with instructions for scheduling, Epic study code, and study RRR name
Confidential

19. Role of Study Coordinator/Study Team
Reviews RRR Account invoice for expected and unexpected charges
Contacts Research Charge Capture & Billing Staff when:
Study invoice includes incorrect and/or disputed charges
“Expected but missing" charges are not on the invoice requiring review or patient accounts and charge capture process flow
Patient is billed for services that should be paid for by the study budget
Coordinates authorizations and payments for research invoices.
Finalizes Epic and PATS participant associations when all research-related, patient or study-billable services are complete
Confidential

20. Role of SCCA Scheduling/TC
Scheduling and linking of research-related (screening and treatment) visits per study team documentation.
SRO’s may be returned to Study Team if:
RS account and billing information is incomplete or not provided
Orders are unclear
Each appointment scheduled that has research-related services will:
Be linked to the RS account provided on the SRO
Include the “Mixed Visit” flag used at SCCA
Have an appointment note populated with RS information
Scheduled visits CANNOT be linked to a study until the study team has associated the research participant with that study in Epic

21. Role of Clinical Research Billing Analysts
Performs Daily Monitoring and Quality Monitoring of charges and accounts
Research-billable charges per Billing Documentation
Participant-billable charges per Billing Documentation
Charge correction
Reviews and analyzes charges daily in Epic Error WQs
Re-pricing of study billable charges
Identifies and tracks charge error trends
Review of specific charge flow for root cause of error

22. Role of Clinical Research Billing Trainer
Develops and provides research revenue cycle training to study and clinical staff
General training
One-on-one training
Team training
Department training
Remedial training based on charge analysis root causes
Operational/workflow issues
Examples:
Participants not associated with study
Appointments not linked, incorrect study codes used
Checklists not received
Follow-up post training
Escalates compliance risks to SCCA Corporate Integrity Office
Confidential

23. Role of Research EAP Coordinators
Reviews and analyzes charges daily in Epic Error WQs
re-pricing of study billable charges based on the Research Fee Schedule 
Maintains the Research Fee Schedule and research pricing for all SCCA activities
Provides research pricing quotes to study staff during implementation
Confidential

24. Role of SCCA Research Invoicing
This position/role resides in the Patient Accounting Office
Generates invoices to study team for review and payment
RRR Billing Cycle is open for one month at a time
Invoices are printed 15 days after the monthly billing cycle ends
Triages study team communication related to
Incorrect or disputed charges on the study invoice
“Expected but missing” charges not reflected on the study invoice
Charges billed to the participant in error
Performs collection activities for outstanding study invoices
Collaborates with Clinical Research Billing on issues and training needs

25. Role of SCCA Integrity/Compliance
Performs audits of Research Study Accounts and related Participant Accounts
Performed by Integrity/Compliance Office
Typically retroactive in nature
Billing has already occurred
Payments have already been received
Can span dates of service as far back as two years
Remediation (charge corrections) communicated to:
Principal Investigator and study team
Clinical Research Billing and Training
Confidential

26. System Training for Revenue Cycle
Epic Fundamentals training
basics of the Epic system
Epic Research Participant Linking training
association of patients to studies in Epic
Epic Clinical Trials Referral training
creation of referrals for financial clearance of the participant
Questions about Epic Training? Send an to or call (206)
PATS training
entry of accrual information
Confidential

27. Projects/Workgroups to Watch in 2014/2015
SCCA CPOE (Computerized Provider Order Entry)
Will automate the entry of orders including research orders
Will facilitate the production of research related scheduling orders and requisitions
SCCA Research Business Lifecycle (RBL)
Ongoing review of SCCA workflows, systems and requirements related to research-related billable services
sRAMP – coming ‘soon’ - SharePoint site to initiate the implementation review process and obtain research pricing for new study submissions
Introduction of Patient-Billable ‘RS’ modifier and change to scheduling indicators
UW Enterprise (UW Medicine, UW Physicians and SCCA)
Research Revenue Cycle Workgroup – focused on shared workflows and Epic system
“Single Study Code” – planned move to single “RG” study code for existing “RS, RU or RH” studies
Confidential

28. Key Websites and Contacts
SCCA Clinical Research Billing (Issues and requests for Training)
Kris Pedersen: Sakuntra Fulgenzi:
David Wiens: Elham Lawson:
Azure Kraxberger, Clinical Research Education Specialist, ,
SCCA Clinical Trial Invoicing/Collections
Joy Westgate: ,
SCCA Research EAP Coordinator
Abby Bixby,
SCCA Research Coding Team
SCCA Research Implementation Office
Steve Johnson: ,
Gina Roper: ,
Website:
CRBB – Clinical Trial Budgeting and Billing Office
General Questions:
UW Research Billing Questions:
UWP – University of Washington Physicians
Confidential