SCCA Research Revenue Cycle
From Set Up to Invoice
Orientation for Research Study Staff
Training Objectives
• Understand Key Concepts in SCCA Research Revenue Cycle
‒ Complexity of billing compliance processes
‒ Patient-Billable and Study-Billable services
‒ Studies in Epic vs Studies outside of Epic
• Review SCCA Research Revenue Cycle
‒ Forms
‒ Processes
• Roles and Responsibilities in the Revenue Cycle
• Revenue Cycle Contacts and Websites
Getting Started with Billing Compliance
Charge Capture
and
Compliant Billing
Charge Level indications
of research-related
activities
Orders and Requisitions
SCCA Anticipated
Research Services
Checklists
Medicare Clinical Trial Policy
UW Medicine Comm 101 Policies
UW Medicine Effort Policy
Visit Level direction of
research-related activities
Study and Participant Level
- Billing Documentation
- Participant
registration/association
Billing Systems Complexity
Patient
Accrual
Association
Study Set Up
Epic
Pt Linking
PATS
Charge
Capture
Billing Grid/CTAS
CPOE
Research
PowerPlans
Build
- Special
Instructions
- Study Code and
Modifier (R/RS)
ORCA
-Alert
-Care Plan
Epic
Billing
Scheduling Visit Linking
Scheduling
Orders
Synergy
Epic Scheduling
Charge Review
Invoicing
Corrections
Visit Specific Forms
·
Checklist
·
Supply Sheet
CPOE
Daily
Orders
Charge File
Charge Capture
Automated with
CPOE
= Monitoring
Ancillary Systems
Requisition & Accessions
• Many systems contribute information to “Research Billing”
• Many processes/forms feed information to systems
Patient-billable/Study-billable Services
• 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 Centers for Medicare and Medicaid Service’s (CMS)
Clinical Trials Policy
– Study-billed in error – Lower risk to SCCA, but leads to rework by study
staff and Revenue Cycle staff
• Downstream rework
– SCCA Clinical Research Billing must identify and correct charges
routed in error due to scheduling and ancillary system data entry issues
– Study staff must identify charges routed in error due to scheduling
issues (among other issues) and request correction if missing charges
» This could hold up payment of services to SCCA
– Patient Accounting must make corrections based off of study staff
identified correction requests
» This could hold up payment of services to SCCA
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 registration, scheduling,
charge capture and billing
• Studies not in Epic
– Studies with ‘bill all to patient’ services
– Billing is highly dependent upon the Protocol Accrual Tracking System
(PATS) entries and data flows that in turn drive Epic entries.
Research Revenue Cycle Overview
• Produce bills for participants
• Produce invoices to studies
• Correct misrouted charges per
Billing Documents
• Review charges against
Billing Documents
• CTAS
• CPOE Orders
• Root cause analysis
• Correct charges preinvoicing
• Monitoring of study
billable charges on study
Hospital Account Records
(HAR) prior to invoicing
• Produce Billing Documents
o Schedule of Service, i.e. Clinical Trial Activity Summary (CTAS)
• Current Procedural Terminology (CPT)s for study-related services
• Pricing & coding for study–related services
• Research PowerPlans
Study Set-Up
Invoicing/
Corrections/
Payment
Participant
Identification
Monitoring/
Charge Review
Scheduling
• Associate consented patient to research
study/studies in Epic
• PATS enrollment information triggers
Care Plan and Alert for billing
• Epic Referral for Clinical Trail Financial
Clearance (participant)
• Link visit to study in Epic
• Create Daily Orders
• Epic Referral for Financial
Clearance (services)
o High Cost Drug
o Scans/imaging
Charge Capture
•
•
•
•
Notification of Charging Systems
o Supply Sheet
o Anticipated Research Services Checklist
Provider Documentation for Coding
Computerized Provider Order Entry (CPOE) Orders
Appointment notes
Epic Study Set-Up - Study Accounts Creation
• A study account is created via the set-up process
– Helps ensure proper direction of patient or study-billable researchrelated charges
– Account name in Epic begins with “RRR”
– The clinical trial is registered and assigned an Epic Study Code by
Clinical Research Budget & Billing (CRBB)
• Study Code general format is RG1234567
– R for ‘research’
– G for ‘general’ covers multiple service areas (SCCA, UW, UWP)
– Numeric portion is study specific
• The study code is used on electronic orders or paper forms to
designate the study for activities of ordering, scheduling,
accessioning and charge capture within Epic and the ancillary
systems
Epic Clinical Trials Patient Financial Clearance
Prior to enrollment and/or scheduling for study
• Coordinators request patient-level financial clearance by SCCA
using Epic referrals
– Checks that the patient’s insurance allows participation in
Clinical Trials
– Provide protocol-specific patient-billable services to the
insurance company for review
• Study documents may be provided to the payor for
evaluation if requested by the payor
– Denials can be appealed
• Coordinators can get denial assistance
– Work managed by SCCA Patient Financial Clearance Staff
Epic Participant Association
Timely (within 24 hours) 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 and CRBB of inpatient or Emergency
Department (ED) admissions
• Provides billing indicator for the 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 studybillable activity (end date could also be last date of study-billable activity)
• Patients must be associated with the study account with an active
billing status in Epic prior to scheduling research-related services
Participant Linking outside of Epic
• Work is being done to bring all studies with patient-billable services
into Epic. However, 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
Charge Modifiers for Research
Research Visit Orders
Various electronic and paper forms are used to designate research study related services and items to separate
systems/workflows
• ORCA CPOE PowerPlans - scheduling needs related to research
‒ Protocol-Specific PowerPlan – built to include Epic study codes with the appropriate research modifier
for billing related to a specific protocol
‒ Generic PowerPlan – does not contain any research specific billing details and Epic Study Code and
appropriate research modifier need to be entered for each order selected
•
•
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
‒ Labs are ordered directly and individually in CPOE. Epic visits notes specific to lab services are not
necessary since those will come from ORCA CPOE orders.
‒ The Study Code must be entered in the Orca “Study Code (Research Only)” order entry field for each
Research lab specimen, or test that is to be billed to research.
‒ Purple Research Requisitions are used for samples that the study will handle and route to an offsite lab
for processing and some genetic testing remain on paper. These remaining paper orders are fully
informed by study staff (not by inner note).
•
Radiology Orders - ORCA orders are used for internal radiology research orders (MRI, CT, nuclear medicine,
and PET) coming from SCCA
•
Anticipated Research Services Checklist – provides guidance for coders working to capture charges from
ORCA documentation
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 unless the service or
visit is documented in ORCA by the
providers.
Instructions for completing the form
are located here and on the
Research Staff Resources website.
Roles and Responsibilities in the Revenue Cycle
•
•
•
•
Study Set-Up
Study Coordinator/Study Staff
SCCA Scheduler/Team Coordinator (TC)
SCCA Research Charge Master Coordinator
SCCA Clinical Research Billing
‒ Analysts
‒ Trainer
Invoicing/
Corrections/
Payment
Participant
Identification
Monitoring/
Charge Review
Scheduling
• SCCA Integrity/Compliance
• SCCA Research Invoicing/Corrections/Payment
Charge
Capture
Study Set Up
Role
Responsibility
Contact the SCCA Research Implementation Office
(RIO) to request new study implementation
Study Staff
Study Set-Up
Details
The Implementation process includes a step for designation of
services required for the protocol
Request Research Coding and Pricing from the
CDM Coordinator
Attend Protocol Implementation Meeting (PIM)
and/or Clinical Trials Implementation (CTI) meeting
SCCA
Charge
Description
Master
Coordinator
(CDM)
SCCA Clinical
Research
Billing Analyst
(CRB)
Provides research coding & pricing quotes to
study staff during implementation for SCCA
services
• Pricing - Study pricing for study-billable
services indicated by the protocol
Research Pricing Requests are given on a rolling three fiscal year
quote structure
•
Each fiscal year the fee schedule is evaluated, current
fiscal prices are updated, and an additional year is
then quoted once the prior year expires
•
SCCA fiscal year dates from July 1st – June 30th
• Coding - Current Procedural Terminology (CPT)
codes for services indicated by the protocol
Inform study staff of any special needs or watch
points at the CTI meetings
• Missing or ambiguous/overlapping timepoints on CTAS forms
• Confounding language used in the “Comments” field for a given
test/service
• Clearing up discrepancies and ambiguities in the description of
tests/services (asking for more specific/accurate names).
Participant Identification
Role
Responsibility
Initiate Financial Clearance for
Patient participation in Epic
Enter and maintains participant
information in Epic and PATS
Study Staff
Details
•
Epic Clinical Trial referral begins the
process of Financial Clearance of
Participants prior to research study
enrollment
•
Enter/maintain accrual information for
consented and enrolled patients into
PATS (for Fred Hutch only)
Associate/maintain consented
patient to research study/studies
in Epic
Forward Epic Inbasket notification
on inpatient admissions and ED
notification for billing purposes to
CRBB
Participant
Identification
• Status
• Active Start Date
• Active End Date
•
Finalize Epic and PATS participant
associations with an active end date and
status update when all research-related,
patient or study-billable services are
complete
Scheduling
Role
Study Staff
SCCA
Scheduler/TC
Responsibility
Scheduling
Details
Facilitates electronic orders, requisitions and
other forms for research/clinical services with
study info:
• Epic study code
• Study RRR name
• Special instructions for scheduling
Include in CPOE Special Instructions:
• Cycle/Day
• Study coordinator & contact information
• Study code/protocol number
• Special instructions, i.e. fasting blood draw
Scheduling and linking of research-related
(screening and treatment) visits per orders.
There is a risk that the visit will be linked inappropriately or
not linked if:
• Study account (RG or RS) and billing information is
incomplete or not provided
• Orders are unclear
Each appointment scheduled that has
research-related services will:
• Be linked to the study account (RG or
RS) provided on the ORCA CPOE order
• Include the “Mixed Visit” flag used at
SCCA
• Have an appointment note populated
with study applicable information
Contact study staff to request missing
information on orders that is needed for
research scheduling
‒ Denote the timepoint (e.g. “Cycle 1 Day 8”, or “Week 1”, or
“Visit 3”)
‒ C4D15. Please bill Uric Acid, CBD, and Magnesium to
RG1234567
Scheduled visits CANNOT be linked to a study until the
study team has associated the research participant with that
study with an active billing status in Epic
CPOE orders have a Special Instructions section that helps
provide information to schedulers.
Charge Capture
Role
SCCA
Charge Master
Coordinator
Responsibility
Maintains the Research Fee Schedule for
Charge Capture of study billable charges
Maintains general Fee Schedule to allow for
charge capture of patient billable charges
Optimizes flow of patient and study billable
charge flow through ancillary peer systems
and Epic
SCCA Charge
Capture/
Operations
Systems
SCCA Clinical
Research
Billing Analyst
Addresses daily charges that fail to route
appropriately into or through Epic
Addresses daily research-related charges that
fail to route appropriately onto the appropriate
patient or study account
Charge Capture
Details
Maintains the Research Pricing Requests and research
pricing for all SCCA activities
• Provides price certainty for clinical trials
• Provides consistent methodology for setting
research prices
Reviews and analyzes charges daily in Epic Error work
queues (WQs)
Charges not in the fee schedule and end up in the Error
Pool are manually priced
•
Could be a new service
•
Could be a service done infrequently
Re-prices study billable charges based on the Research
Fee Schedule
This work is done via WQs in Epic
• Research charges for non-linked visits
• Charges that are unclear as to whether they are
related to research
• Missing Epic Research Information
o Patient not linked to the study
o Incorrect visit type
o Missing active billing active status
Monitoring/Charge Review
Role
SCCA Clinical
Research
Billing Analyst
SCCA
Integrity/
Compliance
Office
Responsibility
Performs Daily monitoring and Quality
monitoring of charges and research
accounts
Monitoring/
Charge Review
Details
Reviews and analyzes charges daily in Epic
Account Monitoring WQs
• Re-route study billable charges
• Research-billable charges per
Identifies and tracks charge error trends
Billing Documentation
• Review of specific charge flow for root
• Participant-billable charges per
cause of error
Billing Documentation
• Charge correction
Coordinates with study Billing Contact for questions
• Monitoring of study billable charges related to:
on study billing encounters/DOS/
• Billing Documents
(HAR)s prior to monthly invoicing
• Orders
• Related charges
Performs audits of research-related
study and patient accounts
•
•
Provides communication of remediation •
(corrections)
Typically retroactive in nature
Communicates with Principle Investigator and
Study Staff
Communicates with SCCA Clinical Research
Billing Department
Invoicing/Corrections/Payment
Role
Responsibility
Invoicing/
Corrections/
Payment
Details
Reviews RRR account invoice for expected
and unexpected charges
Study Staff
SCCA
Research
Invoicing
Department
Contact SCCA Patient Accounting Staff when:
• Study invoice includes incorrect and/or disputed
charges
Coordinates authorizations and timely
• “Expected but missing" charges are not on the
payments for research invoices
invoice requiring review of patient accounts and
• Study invoice payment is due 30 days
charge capture process flow
from the invoice date
Generates invoices to study team for review
and payment
• RRR Invoice Cycle is open for one
month at a time
• Invoices are printed 15 days after the
monthly billing cycle ends
Collaborates with Clinical Research Billing on
issues and training needs
This position/role resides in the Patient Accounting Office
Performs collection activities for outstanding study invoices
Triages study team communications
• 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
Role of Clinical Research Billing Trainer
Role
SCCA Clinical
Research
Billing Trainer
Responsibility
Develops training based on charge
analysis root causes provided from the
Clinical Research Billing, Charge
Capture and Invoicing departments
Performs and tracks research revenue
cycle training to study and clinical staff
• New Users
• Remedial
Details
General training
• Semi-annual CRS Clinical Research
Coordinators Training
• Department training
• Team training
• One-on-one training
Operational/workflow issues
Examples:
• Participants not associated with study
Collaborates with trainers from Fred
• Appointments not linked, incorrect study
Hutch, UWM, and SCCA Epic on content
codes used
development
• Checklists not received
Follow-up post training
Escalates compliance risks to SCCA
Corporate Integrity Office
System Training for Revenue Cycle
• Epic Fundamentals training
– overview of SCCA Epic system, how to navigate the system and use
Epic menus and tools
• Epic Research Participant Enrollment training
– association of research studies with patients (enrolling in Epic)
• Epic Referral training
– creation of referrals for financial clearance of the participant for clinical
trails
Questions about Epic Training? Send an email to
epic_training@seattlecca.org or call (206) 288-6294.
• PATS training
– entry of accrual information
– PATS Process and User Documentation
Projects/Workgroups to Watch in 2015
• SCCA Research Business Lifecycle (RBL)
– Ongoing review of SCCA workflows, systems and requirements
related to research-related billable services
• Study Review and Management Portal (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 (CPOE
related)
• 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 (phase two – April to May timeline)
Key Research Revenue Cycle Contacts and Websites
•
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 CDM Coordinator
– Abby Ewing, researchpricing@seattlecca.org
•
SCCA Research Coding Team
– Email: researchcoder@seattlecca.org
•
SCCA Research Implementation Office
– Email: RIO@seattlecca.org
– Website: http://www.seattlecca.org/research-staff-resources.cfm
•
CRBB – Clinical Budgeting and Billing Office
– Email: crbb@uw.edu
– General Questions: 206-543-7774
– CRBB Budget: 206-543-6358
– CRBB Billing: 206-543-9006
•
UWP – University of Washington Physicians
– Email: research@uwp.washington.edu