SCCA Research Revenue Cycle
From Set Up to Invoice
Orientation for New Research Study Staff
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
Getting Started
Charge Capture
and
Compliant Billing
Orders and
Requisitions
Charge Level indications
of research-related
activities
Visit Level direction of
research-related activities
Fee Sheets and
Checklists
Medicare Clinical Trials Policy
UW Medicine
Policies 01 and 03
UW Medicine Effort Policy
Confidential
Study and Participant
Level
- Billing Documentation
- Participant registration
Complexity
• Many Systems contribute information to “Research Billing”
• Many Processes/Forms feed information to Systems
ORCA
Sunquest
LV+
Billing Grid
Powerpath
Synergy
SRO
Pharmnet/
Pyxis
Mosaiq
PATS
RIS
Epic Charge Entry
Epic
Confidential
HEMM
Epic Billing
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
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
Research Revenue Cycle
• Production of Bills for
Participants
• Production of Invoices to
studies
• Correction of misrouted
charges per Billing Documents
Study Set-Up
Billing/Invoicing/
Corrections
• Review charges against
Billing Documents
• Root cause analysis
• Correction of charges
pre-invoicing
• Production of Billing Documents
• CPTs for study-related services
• Pricing for study–related services
Participant
Identification
Monitoring/
Charge Review
Scheduling
• 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)
Charge Capture
• Notification of Charging Systems

Supply Sheet

Anticipated Services Checklist
• Provider Documentation for Coding
Confidential
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
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
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*1234567 (Ex: RS5414003)
– 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
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
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
Participant Linking outside of Epic
• Work is being done to bring all studies with patientbillable 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
Charge Modifiers for Research
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
Anticipated Research Services Checklist
Anticipated Research Services Checklist
• Supports all service areas except
Profees, Laboratory and Radiology
• Submitted via email to SCCA
Research Coding Team at:
ResearchCoder@seattlecca.org
• 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
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
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
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
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
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
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
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
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
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
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 email to
“epic_training@seattlecca.org” or call (206) 288-6294.
• PATS training
– entry of accrual information
Confidential
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
Key Websites and Contacts
• SCCA Clinical Research Billing (Issues and requests for Training)
–
ResearchRC@seattlecca.org
Kris Pedersen: 206-288-7626
Sakuntra Fulgenzi: 206-288-1091
David Wiens: 206-288-6276
Elham Lawson: 206-288-7636
Azure Kraxberger, Clinical Research Education Specialist, 206-288-7768, akraxber@seattlecca.org
• SCCA Clinical Trial Invoicing/Collections
–
Joy Westgate: 206-288-1107, jwestgat@seattlecca.org
• SCCA Research EAP Coordinator
–
Abby Bixby, researchpricing@seattlecca.org
• SCCA Research Coding Team
–
researchcoder@seattlecca.org
• SCCA Research Implementation Office
–
–
–
–
Steve Johnson: 206-288-1287, sjohnson@seattlecca.org
Gina Roper: 206-288-6607, groper@seattlecca.org
Email: RIO@seattlecca.org
Website: http://www.seattlecca.org/research-staff-resources.cfm
• CRBB – Clinical Trial Budgeting and Billing Office
–
–
–
Email: crbb@u.washington.edu
General Questions: 206-543-7774
UW Research Billing Questions: 206-543-9006
• UWP – University of Washington Physicians
–
Confidential
Email: research@uwp.washington.edu