SCCA Research Revenue Cycle

From Set Up to Invoice

Orientation for Research Study Staff

Clinical Research Billing

SCCA

Training Objectives

• Understand Key Concepts in SCCA Research Revenue Cycle ‒ Patient-Billable and Study-Billable services

‒ Complexity of billing compliance processes

• 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

CPOE Orders

Requisitions & Accessions (peer systems)

SCCA Anticipated Research

Services Checklists

Medicare Clinical Trial Policy

UW Medicine COM -101 Policy

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

Understanding Patient-billable/Study-billable Services

Both need to be understood and communicated for compliant billing

– Patient-billed in error - High compliance risk to SCCA and study

• Potential for ‘double-dipping’ or double-billing 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

• Facility overpayment

– Study-billed in error – Lower compliance risk to SCCA, but leads to rework by study staff and Revenue Cycle staff and can result in lack of payment

• 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

• Timely filing consideration may prevent facility from getting paid

– Patient Accounting must make corrections based off of study staff identified correction requests

• This could hold up payment of services to SCCA

Charge Capture

Charge Review Invoicing Corrections

Epic Charge Capture/Billing Study Set Up

CPOE Research

PowerPlans Build

- Special Instructions

- Study Code and Modifier (R/RS)

Billing Grid/DBT

Billing Systems Complexity

• Many systems contribute information to “Research Billing”

• Many processes/forms feed information to systems

= Areas Monitored

Charge File

Ancillary Systems Requisition & Accessions

Epic Scheduling

Visit Specific Forms· Checklist· Supply Sheet

Scheduling Orders

Automated with CPOE

Scheduling

CPOE Daily

Orders

Visit Linking

PATS

EpicPt Linking

Patient

Accrual

Association

ORCA-Alert

-Care Plan

Research Revenue Cycle Overview

Study Set-Up

Participant Identification

Ordering/ Scheduling

Informing Charge Capture

Monitoring/

Charge Review

Invoicing/

Corrections/

Collections

• sRAMP

Produce Billing Documents

o Schedule of Service, i.e. Billing Grid and/or Detailed

Budget Tool

o Pricing & coding (CPT)s for study–related services

• Clinical Trial registration and Epic study code assignment

• Protocol Implementation Meeting (PIM) and/or Clinical Trials Implementation (CTI) meetings

• Research PowerPlans builds

• Associate prior to scheduling patient to research study/studies in Epic

• PATS enrollment information triggers Care Plan and STUDY Alert

• Epic Referral for Clinical Trial Financial Clearance (participant)

• Create Daily Orders – Research or Generic PowerPlans, inform w/study code & modifier

• Link visit to study in Epic • Epic Referral for Financial Clearance (services)

o Scans/imaging o Genetic Testing o Ancillary Services (PT) o High Cost Drug (notify pharmacist)

• Notification of Charging Systems

o Supply Sheet o Anticipated Research Services Checklist

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

• Review charges against Billing Documents

• Billing Grid/CTAS • CPOE Orders

• Root cause analysis • Correct charges pre-invoicing • Monitoring of study billable

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

• Special review monitoring • Patient/study billing inquires

• Clinical Research Billing generates and routes invoices to studies

• Patient Finance generates bills for participants

• Corrects misrouted charges per study Billing Documentation & collaboration with study staff

• Processes payments to study invoices

• Study invoices paid within 30 days of receipt

• Collections & escalation of delinquent invoices

Study Set Up

Role 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

Submit study through sRAMP

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

Produce Billing Documents

• Schedule of Service, i.e. Billing Grid and/or Detailed

Budget Tool

SCCA

Revenue

Charge Mgmt.

Coordinator

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 billing grid

and pricing request table

Research Pricing quotes 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 Billing Grid

• 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

sRAMP (Study Review and Management Portal)

Study Set-Up

A web-based, single point of entry portal for study submission, implementation review and communication for all studies in the Cancer Consortium

Epic Study Set-Up - Study Accounts Creation

• A study account is created via the study implementation process

– The clinical trial is registered and assigned a study account name and an

Epic Study Code by UW Clinical Research Budget & Billing (CRBB)

• Study account name in Epic begins with “RRR”

• Study Code general format is RG1234567

– R for ‘research’

– G for ‘general’ covers multiple service areas (SCCA, UW, UWP)

– Numeric portion is study specific

– Modifiers help ensure proper direction of study or patient-billable

research-related charges

• If study code is on a charge with an R modifier it routes to the study

• If study code is on a charge with an RS modifier it routes to the patient

• If no study code is on a charge it always routes to the patient

– The study code is used in conjunction with modifiers 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

Study Set-Up

Participant Identification

Role 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

Epic Participant Association

Timely (within 24 hours of identification of first DOS with study or patient

billable services) participant-to-study association in Epic is extremely

important for accurate and compliant billing

• Allows linking of participant’s visits to the study

• Provides an indication for billing offices of a patient’s participation on a study

Key Elements of patient-to-study association in Epic

– Status (active vs. inactive) – indicates where the participant is in the billing flow

– Active Start Date – aligns with the first date of research-related, patient or study-

billable activity. Triggers the Epic STUDY alert.

– Active End Date – aligns with the last date of research-related, patient or study-

billable activity. Triggers the removal of the Epic STUDY alert.

• Generates notification to study staff in the event of inpatient or Emergency

Department (ED) admissions who then forward notification to CRBB

• Patients must be associated with the study account (RG code) with an active billing

status in Epic prior to scheduling research-related services • In absence of association, schedulers will not be able to link visit and will schedule without it

Participant Identification

Epic Clinical Trials Patient Financial Clearance

Completed prior to enrollment and/or scheduling for study

• Study staff request patient-level financial clearance by SCCA using

Epic referrals procedure

– Checks that the patient’s insurance plan allows participation in

Clinical Trials and determine if SCCA is contracted with the

patient’s payor

– 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

• SCCA Patient Financial Clearance Staff coordinators provide

assistance with appeals

Participant Identification

Ordering/Scheduling

Role Responsibility Details

Study Staff

Associate participant prior to scheduling

Facilitates electronic orders, requisitions and

other forms for research/clinical services with

study info:

• Epic study code (RG Code)

• Modifiers

• Study RRR name (for remaining paper

orders or requisitions at SCCA or UWMC)

• Special instructions for scheduling

Include in CPOE Orders Special Instructions field:

• Epic study code without spaces (include R/RS modifier)

• RG1234567X

• Cycle/Day (CXDX)

Denote the timepoint e.g. “Cycle 1 Day 8”, or “Week

1”, or “Visit 3”)

• Study coordinator name & contact information

• Miscellaneous notes; i.e. fasting blood draw

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 Epic study account (RG

Code)

• 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:

• Epic study account (RG Code) 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.

Ordering/

Scheduling

Charge Modifiers for Research Ordering/

Scheduling

Research Visit Orders

Various electronic and paper forms are used to designate research study related services and items to separate

systems/workflows

• Split Supply sheets (Infusion, Procedures) - study vs patient-billable supplies

‒ To initiate pre-printed Split Supply sheets contact SCCA Material Management

• Lab Orders and Requisitions – directs lab-related activities in Epic and other systems

‒ Labs are ordered directly and individually in CPOE and the visit needs to be linked to the patient in Epic

‒ The Study Code and R/RS modifier 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 through ORCA orders. These orders are fully informed by study

staff, except SCCA AMB Bone Marrow PowerPlans.

• 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

Ordering/

Scheduling

• 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

R modifier designates study-billable research related charges

RS modifier designates patient-billable research related charges

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 billable

• Examples: • MA assisted EKGs • Oral Chemo Administration • Blood Draws (36415, 36591, 36592) • 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.

Ordering/

Scheduling

Charge Capture Informing Charge

Capture

Role Responsibility Details

SCCA

Revenue

Charge Mgmt.

Coordinator

Maintains the Research Fee Schedule for

Charge Capture of study billable charges

Maintains the Clinic Fee Schedule to allow

for charge capture of patient billable

charges

Maintains the Research Pricing quotes and research

pricing for all SCCA activities

• Provides price certainty for clinical trials

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 study

o Incorrect visit type

o Missing active billing active status

Monitoring/Charge Review

Role Responsibility Details

SCCA Clinical

Research

Billing Analyst

Performs Daily monitoring and Special

Review of charges and research

accounts

• Research-billable charges per

Billing Grid and Orders

• Participant-billable charges per

Billing Grid and Orders

• 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/Payment Invoicing/

Corrections/ Collections

Role Responsibility Details

Study Staff

Review RRR account invoice for

expected and unexpected charges

Review, authorize, and pay research

invoice in a timely manner

• Study invoice payment is due 30

days from the invoice date

Contact SCCA Clinical Research Billing Analysts

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

Clinical

Research

Billing

Analyst

Generate invoices to study team for

review and payment

• RRR Invoice Cycle is open for

one calendar month at a time

• Invoices are printed and sent

out 15 days after the monthly

billing cycle ends

Performs collection activities for outstanding study

invoices

• Escalates as needed to leadership

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

System Training for Revenue Cycle

• PATS training

– entry of accrual information

– PATS Online Training Module (look under Online Modules)

– PATS Process and User Documentation (User Guide)

• Epic Fundamentals

‒ overview of SCCA Epic system, how to

navigate the system and use Epic menus

and tools

• Epic Research Participant Enrollment

‒ association of research studies with

patients (enrolling in Epic)

• Epic Referral

‒ creation of referrals for financial clearance

of the participant for clinical trails

Click here for Epic Class Enrollment Information or visit

Epic Education on the SCCA Intranet

• ORCA 100: Fundamentals

‒ navigate the electronic medical record to

find patient information specific to SCCA

• ORCA 300: Advanced for Researchers

‒ transcribe the consenting process in a

clinical note, proposing orders (including

prebuilt PowerPlans as well as Generic

Templates) and starting regimens

Click here for ORCA Training Schedule and

Registration Instructions or visit ORCA Education on

the SCCA Intranet

Clinical Research Billing Training

Role Responsibility Details

SCCA Revenue

Cycle

Education

Specialist

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

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

• Appointments not linked, incorrect study

codes used

• Checklists not received

Key Research Revenue Cycle Contacts

• SCCA Clinical Research Billing (Issues, Invoicing/Collections and Requests for Training) – ResearchRC@seattlecca.org 206-288-7280

Kris Pedersen: 206-288-7626 Sakuntra Fulgenzi: 206-288-1091

Elham Lawson: 206-288-7636 Joy Westgate: 206-288-1107

Azure Kraxberger-Unger, Revenue Cycle Education Specialist, 206-288-7768,

akraxber@seattlecca.org

• SCCA Patient Financial Services

− Email: pfsclintrials@seattlecca.org

• SCCA Research Coding Team (for submitting Anticipated Research Services Checklist) – Email: researchcoder@seattlecca.org

• SCCA Revenue Integrity Coordinator (Pricing and Coding Questions)

– Abby Ewing, researchpricing@seattlecca.org

• SCCA Research Implementation Office – Website: http://www.seattlecca.org/research-staff-resources.cfm (For Forms and Form Completion

Instructions)

• CRBB – Clinical Research Budget and Billing – Email: crbb@uw.edu – General Questions: 206-543-7774 – CRBB Budget: 206-543-6358 crbudget@uw.edu – CRBB Billing: 206-543-9006 crbills@uw.edu

• UWP – University of Washington Physicians

– Email: research@uwp.washington.edu

Tips for Compliant Billing

Associate patient to study in Epic within 24 hours of study billable services

• Status (active vs. inactive) – indicate where the participant is in the billing flow

• Active Start Date – enter the first date of research-related, patient or study-billable activity

• Active End Date – enter the last date of research-related, patient or study-billable activity

Update patient Epic enrollment status in a timely manner

Associate patient to study in PATS • Enrolled date - triggers Epic STUDY Alert

• Billing end date - triggers the removal of the Epic STUDY Alert

Update Billing Grid and/or Detailed Budget Tool and PowerPlans whenever any billing

assumptions have changed

Complete Orders Correctly

Include in CPOE Orders Special Instructions field:

• Cycle/Day (CXDX) - Denote the timepoint e.g. “Cycle 1 Day 8”, or “Week 1”, or “Visit 3”)

• Study coordinator name & contact information

• Epic study code without spaces (including R/RS modifier) - RG1234567X

• Miscellaneous notes; i.e. fasting blood draw

Complete the Anticipated Research Services Checklist and submit to Research Coding

Reviews RRR account invoice for expected and unexpected charges • Contact Clinical Research Billing ASAP with questions or to dispute charges & communicate missing charges

Pay invoice within 30 days from the invoice date

THANK YOU