ORIENTATION FOR NEW RESEARCH STUDY STAFF Clinical Trial Charge Capture and Research Invoicing October 2012

Role of Research Charge Capture Analyst/Trainer Research Charge Capture Analyst receives charges routed to the study accounts via Epic and reviews as designed –Participants not associated with study *new functionality 10/23/12* –Appointments not linked, incorrect study codes used –Checklists not received –Special pricing required Error trends are identified and tracked –Training opportunities, operational issues, compliance risks Account Monitoring for Compliant Billing Practices Collaborates with internal and external offices: – Research Invoicing and Collections Office – Research Implementation and CRBB – Integrity and Compliance Assist with Clinical Trials Financial Clearance

What is an RS Study account? A Study account is created to: –Direct clinical trial charges to the research study –Prevent services paid for by the study from being billed to the patient or his/her insurance. The clinical trial is registered and receives Study Code assignments for each institution providing services to clinical trial participants. –Examples: RS = SCCA RU = UWMC RH = Harborview Each study instance (RS, RU, RH) will require a participant be Associated with the study prior to scheduling *new functionality 10/23/12* The name of research study accounts begin with an “RRR” prefix

SCCA’s Research Fee Schedule SCCA’s Research Fee Schedule was created to: – Recoup costs for research services performed at SCCA – Provide price certainty for clinical trials (no surprises) – Adhere to a consistent methodology for setting research prices – Categories of services Clinical Services Supplies & Drugs How are Research Fee Schedule prices set? – Cost recovery will be based on SCCA’s Medicare Cost Report – Research Rate is calculated based upon SCCA’s cost at the department level to provide service When do prices/quotes change? – Research Fee Schedule is a rolling three year quote structure – If a study has received pricing yet the clinical trial hasn’t opened in over a year – updated pricing must be requested

Role of Study Coordinator in Research Billing New study implementation begins with contacting the SCCA Research Implementation Office (RIO) –Research Price Quotes are requested and provided during this process Once study is established: –Enroll participants Associate participants to research study (RS Account) via Epic *new functionality 10/23/12* –Enrollment data will populate PATS database for Gen/Hem Onc & Solid Tumor Groups Submit enrollment forms for entry to: –Gateway Data Management = Transplant patients –PSOC = Puget Sound Oncology Consortium –Provide clear and concise scheduling request and clinical orders for your participants Study Coordinator must complete and submit the Anticipated Research Services Checklist –No later than 2 days prior to services rendered –If an add-on appointment or service – route as soon as possible

Role of Study Coordinator in Research Charge Capture and Billing Obtains Clinical Trial Financial Clearance prior to performing research services Associates enrolled participants to study accounts in Epic *effective October 23, 2012 Submits scheduling request orders for research/clinical services that are clear and include the appropriate patient scheduling instructions, study RS billing number and study RRR name Routes Checklist to Research Coding Team via (preferred) or fax 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 paid for by the study budget Study team coordinates authorizations and payments for research invoices.

Research Visit Paperwork Scheduling Request Orders. –Preprinted SRO’s helpful –To initiate preprinted SRO process contact the Research Implementation Office Infusion –Split Supply sheets if there are supplies the study is paying for Lab Orders and Requisitions –Lab Appointments in Epic: Special Instructions “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 *samples the study will handle and route to an offsite lab for processing* Anticipated Research Services Checklist –Service areas supported (every department EXCEPT Laboratory and Radiology) –Submit via to SCCA Research Coding Team –EKG Visit Types *see attached visit types template* Radiology –Order form specifically for scanning services *see example provided*

Role of Team Coordinator Staff Scheduling of Research-related Visits Research related visits CANNOT be scheduled until the study team has Associated the research participant with study in Epic *New functionality 10/23/12* –Screening –Enrolled Scheduling appointments for research-related services identified from the study team’s submitted Scheduling Request Order (SRO) –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 –Appointment notes will be populated with RS information

Medicare CTP Coverage Overview

Medicare CTP: Research Billing Requirements If study related item/service is: –A “Routine Cost” –Part of a “Deemed Qualified” clinical research trial –To be billed to Medicare Note: Other insurance carriers may follow Medicare in the future SCCA as a billing entity must: –Apply the “Q01” modifier to CPT codes (effective 04/07/08) –Apply the “V70.7” as the secondary ICD-9 diagnosis code –Denote study information in the participant’s medical record

How are Medicare Modifiers Applied? Study Staff Associates patient enrollment into Epic *new functionality 10/23/12* Health Information Management (HIM): – Places Research Care Plan Alerts on the participant account – Sets participant account flag for Deemed Qualified Clinical Trials FQUAL = FHCRC based study; FH holds funds SQUAL = UWMC/SCCA based study; UW holds funds Charge Capture AND Billing: – Account flags automate billing process to ensure charges on enrolled participant accounts receive: “Q01” modifier is placed on CPT codes “V70.7” is added as the secondary ICD-9 diagnosis code on the claim

Role of Research Invoicing and Collections Office This position/role resides in the PFS Billing Team 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 Study team communicates to this position when: –The invoice includes incorrect charges requiring correction or has disputed charges –“Expected but missing” charges are not on the invoice requiring review of patient accounts and charge capture process flows Performs collection activities for invoices outstanding Collaborates with Clinical Trial Charge Capture Analyst/Trainer Research Billing and Collections Specialist: Joy Westgate:

SCCA Clinical Trial Charge Capture Monitoring and Auditing Monitoring Accounts –Objective: Identify process gaps and/or errors on the front-end prior to billing –Performed by Clinical Charge Capture Analyst/Trainer –Occurs on both participant and study accounts –Billing corrected prior to being issued to the incorrect entity for payment Patient/insurance Research account Auditing 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 Trial Billing Specialist

Clinical Trial Charge Capture Training and Questions One-on-one training Team training Department Training Clinical Trial Coordinator Meetings Research Study Coordinator Meetings Annual New Research Study Staff Training Questions or need more information? Kris Pedersen:

Key Websites and Contacts SCCA Clinical Trial Charge Capture Analyst/Trainer –Kris Pedersen: , SCCA Clinical Trial Invoicing/Collections –Joy Westgate: , SCCA Research Coding Team – SCCA Research Implementation Office –Steve Johnson: , –Gina Roper: , –Linda-Jo Greenberg: , CRBB – Clinical Trial Budgeting and Billing Office – –General Questions: –UW Research Billing Questions: UWP – University of Washington Physicians –