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Research Subject Registration & Grant Charges

Clinical Research Education Series

August 29th, 2006

Marta Sears

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Overview

Form Review Discuss SOC (Standard of Care) Tips Professional Fees Summarize Primary Changes How to Set Up the form Informing & Scheduling the Subject The Bill Sample Packet Review

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What ?

Replacement Clarian FormCharges

and Registration

Related Process

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Why ?

Process Improvement↓ Billing Errors↓ Uncollected $Track

# subjects # studies room use

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How to Implement ?

Committee:

Team, Team Managers, Project Directors

Pilot: 6/1/06 to 8/31/06

Initiation: 9/1/06

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“The Form”

Current Version

“GRANT CHARGE FORM”

New Version, eff 9/1/06

“RESEARCH REGISTRATION /

GRANT CHARGE FORM”

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Abbreviated Registration

Box #1

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Study Contacts

Box #2

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Brief ~or~ Full Registration

Box #3

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“Routine Services” ~or~ Standard of Care (SOC)

A service that would be provided to the patient

whether or not they were participating in a clinical trial.

The service is medially indicated for the diagnosis ~or~ for a patient receiving the specific drug or treatment.

Example: wlkly PT/PTT for coumadin titrations Intercurrent unrelated medical event, ie: UTI

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NOT a routine SOC research services

Not routine SOC: Performed only because of clinical trial participation Tests Procedures Visits

Establish at time of budget process. Bill to sponsor

Example: Protocol required Daily PT/PTT when wkly is the standard

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Study Identifiers / Account #’s

Box #4

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Charge descriptions

Box #5

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Box # 5

Note List Grant Account charges ONLY Do NOT list NON-Grant Account Charges

Pre-Fill box columns…..for a specific study Where do I find service codes & charges??? Is the charge going to match our budget??

“√” all items……for a specific visit date

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Where are Service Codes & Charges???

Abbreviated Price List Small sample Missing additional associated charges

Requiring contact with Clarian service area Study Manager, down the road, to include pricing

Contact List (service area) Verify charges & Associated charges w/ Clarian service area

Obtain quote via email (written) ie: the medication charge in addition to a procedure charge

Maintained by UH AOC, Riley not listed Prior FIS / EPIC documents

May list procedure svc code & charges

Abbrev Price List & Contact List: Will be kept on SOM OCR web site

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Will Charge Match our Budget??

IDEALLY Service codes & Charges are identified

at the point in time that the study budget is built

Verify Charge w/ Clarian PFS 35% discount Verify service area Charge matches PFS Svc Code Charge

How? List quoted charge on “the form” & submit to PFS However, charge will not continue to be seen on the form

Clarian Charges do ↑ Sponsor budget should allow for ↑ expenses

PFS: Patient Financial Service, 962-8090

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Professional Fees

“The form” is a Clarian form However, the form may be utilized for professional

fees, ie: Radiology Associates, etc. if acceptable w/ the specific professional practice area

The coordinator or department support person will contact the professional area to determine / negotiate charges & to verify what form will be used

Consideration should be made if the professional is already compensated through the grant account, ie: the PI

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Primary Changes in the Process

Clarian now tracks subject visits, even if there are no procedures or Clarian staff utilized

Check Box #5 “Exam/Consult Room” …. No Charge Now submit expected grant charges up front to

Camille, improving communication & ↓’ing chance for subject billing error

Now encouragement to submit form directly to each service area or practice plan (ie: Radiology Associate) to ↓ patient billing errors

Pilot program improved communication about research between Clarian and IU, with other potential committee’s to come

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Related Process

Refer to the “Research Grant Process”

document

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Set Up a Pre-Filled Form

Contact Camille Gilliam at PFS w/ information for Box #2,4,5 May also include quotes to PFS for verification May send via fax, email or phone call

Send Camille the IRB approved DRA

Camille will provide “the form” by email (Word Doc) w/ the assigned Clarian Grant Account #

Camille will also campus mail the form, along with other information

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Camille GilliamPatient Financial Services

Email cgilliam@clarian.org

Fax# 962-0861Phone# 962-8090

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Informing the Subject

Inform subject: Under what circumstances Full Registration (obtaining insurance information) may occur

Inform subject: What expenses are paid or not paid by the grant account

Inform subject: What expenses may be the patient/3rd party responsibility & if pre-certification is needed Consider standard of care expenses Consider adverse events related to the study Consider medical events not related to the study

The Informed Consent should adequately describe The Informed Consent should be signed prior to study

related procedures

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Scheduling the Subject

Schedule subject, including use of “the form”, appropriate requisition, per Clarian service area standards, ie: Phlebotomy: Walk In ECG: Walk In Neuro MD visit: Outlook, Full Registration PFT Lab: Call in advance GI: Place on a list if CRC only MDC: List if CRC only

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Pre-Filled subject specific Form

Complete Box #1 & 3 for the specific subject At or Prior to the subject visit:

Complete date of visit (top) Check off applicable charges in Box #5 Submit copy directly to the service area or

professional area, ie: 1 form to UH Radiology 1 form faxed to Radiology Associates (Rita Bridge) Emailing the form w/ subject identifiers is not secure

Service area will submit the form to Camille Camille will call if charge is unclear

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The Bill

Subject receives bill Assess if Grant Acct or pt/3rd Party responsibility

If Grant Acct, then process FIS (Financial Information Services) expense

itemization for verification & approval. If not correct put on Hold, notify accounting

If non-research staff are utilized = Charge ie: Difficult stick. Request Clarian staff to draw =

charge

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Clinical Trials Charge Forms

Clarian “Research Registration / Grant Charge Form”, 35% discount, Camille Gilliam

962-8090 “Custom Lab Test Request”, research rates, contact Kim Weir 745-2775

Wishard Complete “Research Study Initiation Request Form” & send to Alice Roff at

Wishard. Contact Tina Noonan 278-5802. Use of over-ride number. New IU SOM flat research rate of 125% of Medicare at Wishard

Practice Plan Encounter Forms Contact appropriate practice plan administrator

Contact Marcia Gonzales, Compliance Officer (278-4891) for questions, in addition to

seeking direction from service area administration (ie: UMDA, Clarian dept)

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Handouts

Research Registration / Grant Charge Form Illustrations / Samples Research Grant Process Flow Sheet Clarian Grant Charge Form Procedure for PFS Contact List Abbreviated Clarian Charge Code