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 BillingOrders and Requisitions

SCCA Anticipated Research Services

Checklists

Medicare Clinical Trial Policy

UW Medicine Comm 101 Policies

UW Medicine Effort Policy

Study and Participant Level - Billing Documentation

- Participant registration/association

Visit Level direction of research-related activities

Charge Level indications of research-related

activities

Charge File

Synergy

Charge Capture

Charge Review Invoicing Corrections

Epic Billing

Charge Capture

EpicPt Linking

PATS

Patient AccrualAssociation

ORCA-Alert

-Care Plan

Billing Systems Complexity

• Many systems contribute information to “Research Billing”• Many processes/forms feed information to systems

= Monitoring

Billing Grid/CTAS

Study Set Up

CPOE Research

PowerPlans Build

- Special Instructions

- Study Code and Modifier (R/RS) Ancillary Systems

Requisition & Accessions

Epic Scheduling

Visit Specific Forms· Checklist· Supply Sheet

Scheduling Orders

Automated with CPOE

Scheduling Visit Linking

CPOE Daily

Orders

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

Study Set-Up

Participant Identification

Scheduling

Charge Capture

Monitoring/

Charge Review

Invoicing/

Corrections/

Payment

• Produce Billing Documentso 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

• 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 Drugo Scans/imaging

• Notification of Charging Systemso Supply Sheeto Anticipated Research Services Checklist

• Provider Documentation for Coding• Computerized Provider Order Entry (CPOE) Orders• Appointment notes

• Review charges against Billing Documents

• CTAS• CPOE Orders

• Root cause analysis• Correct charges pre-

invoicing• Monitoring of study

billable charges on study Hospital Account Records (HAR) prior to invoicing

• Produce bills for participants• Produce invoices to studies• Correct misrouted charges per

Billing Documents

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 research-related 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 study-

billable 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 OrdersVarious 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 ChecklistAnticipated 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.

One

checklist per

patient per

day, for all

service

locations in

the clinic

Roles and Responsibilities in the Revenue Cycle

• Study Coordinator/Study Staff• SCCA Scheduler/Team Coordinator (TC)• SCCA Research Charge Master Coordinator• SCCA Clinical Research Billing

‒ Analysts‒ Trainer

• SCCA Integrity/Compliance• SCCA Research Invoicing/Corrections/Payment

Study Set-Up

Participant Identification

Scheduling

Charge Capture

Monitoring/

Charge Review

Invoicing/

Corrections/

Payment

Study Set UpRole Responsibility Details

Study Staff

Contact the SCCA Research Implementation Office (RIO) to request new study implementation

Request Research Coding and Pricing from the CDM Coordinator 

Attend Protocol Implementation Meeting (PIM) and/or Clinical Trials Implementation (CTI) meeting

The Implementation process includes a step for designation of services required for the protocol

SCCA Charge

Description Master

Coordinator (CDM)

Provides research coding & pricing quotes to study staff during implementation for SCCA services• Pricing - Study pricing for study-billable

services indicated by the protocol

• Coding - Current Procedural Terminology (CPT) codes for 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

SCCA Clinical Research

Billing Analyst(CRB)

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).

Study Set-Up

Participant IdentificationRole Responsibility Details

Study Staff

Initiate Financial Clearance for Patient participation in Epic

Enter and maintains participant information in Epic and PATS

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

• 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)

• 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

Participant Identification

SchedulingRole Responsibility Details

Study Staff

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

‒ 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

SCCA Scheduler/TC

Scheduling and linking of research-related (screening and treatment) visits per orders.

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

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

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. 

Scheduling

Charge CaptureRole Responsibility Details

SCCA Charge Master

Coordinator

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      

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

SCCA Charge Capture/

Operations Systems

Optimizes flow of patient and study billable charge flow through ancillary peer systems and Epic

Addresses daily charges that fail to route appropriately into or through Epic

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

SCCA Clinical Research

Billing Analyst

Addresses daily research-related charges that fail to route appropriately onto the appropriate patient or study account

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 studyo Incorrect visit typeo Missing active billing active status

Charge Capture

Monitoring/Charge ReviewRole Responsibility Details

SCCA Clinical Research

Billing Analyst

Performs Daily monitoring and Quality monitoring of charges and research accounts

• Research-billable charges per Billing Documentation

• Participant-billable charges per Billing Documentation

• Charge correction • Monitoring of study billable

charges on study billing encounters/DOS/ (HAR)s prior to monthly invoicing

Reviews and analyzes charges daily in Epic Account Monitoring WQs

• Re-route study billable charges

Identifies and tracks charge error trends• Review of specific charge flow for root

cause of error

Coordinates with study Billing Contact for questions related to:

• Billing Documents• Orders • Related charges

SCCA Integrity/

Compliance Office

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                              

Monitoring/

Charge Review

Invoicing/Corrections/PaymentRole Responsibility Details

Study Staff

Reviews RRR account invoice for expected and unexpected charges

Coordinates authorizations and timely payments for research invoices

• Study invoice payment is due 30 days from the invoice date

Contact SCCA Patient Accounting Staff when:• Study invoice includes incorrect and/or disputed

charges• “Expected but missing" charges are not on the

invoice requiring review of patient accounts and charge capture process flow

SCCA Research Invoicing

Department

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

Invoicing/

Corrections/

Payment

Role of Clinical Research Billing TrainerRole Responsibility Details

SCCA Clinical Research

Billing Trainer

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

Collaborates with trainers from Fred Hutch, UWM, and SCCA Epic on content development

Follow-up post training

Escalates compliance risks to SCCA Corporate Integrity Office

General training• Semi-annual CRS Clinical Research

Coordinators Training • Department training• Team training• One-on-one training

Operational/workflow issuesExamples:• Participants not associated with study • Appointments not linked, incorrect study

codes used• Checklists not received

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.orgKris 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