The University of Texas Health Science Center at Houston

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The University of Texas Health Science Center
at Houston

• Clinical Research Budgeting and Billing Program
• Grants 101
• Catey Carter, RN, CCRC

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Clinical Research Budgeting and Billing Compliance
Website ttp//www.uth.tmc.edu/research/clinical
Catey Carter, RN, CCRC Clinical Trials Resource
Coordinator UTHSCH Office of Research 713-500-352
4 Catharine.V.Carter_at_uth.tmc.edu
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Clinical Budget and Billing Responsibilities

• Develop study budget
• Determine financial responsibility of research
  tests and services
• Determine if research billing is indicated
• Set up research billing accounts
• Identify research subjects
• Identify each research service to be billed to
  the study

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Clinical Budget and Billing Responsibilities

• Create a billing ledger (billing grid)
• Track each subject, visit and research charge on
  billing ledger
• Reconcile statements for research services
• Authorize payment from UT study account to
  service provider
• Review payment schedule according to the contract
• Invoice sponsor per payment schedule
• Track reimbursements per payment schedule

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UTHSC-H Clinical Trials Pre-Award Flowchart
Federal/ Sponsor Initiated Protocols

• PI/ Research Staff Develops Budget
• - Consultation Catey Carter, RN
• Determination -Research vs. Standard of Care
• UT Clinical Research Price List
• Identify all Research costs
• Preparation of Research Budget Template
• Sponsor Budget
• Internal Budget
• Sponsor Negotiation

Include professional fees for hospital services
as effort or billable to sponsor for research
BUDGET
PI/Research staff

• OSP is provided- Review and Approval Form,
  Deans office/ Dept. approval
• - Protocol
• - Clinical Study Agreement
• Subcontract Requirements (if indicated)
• List of Allowable Research Charges
• Detailed Internal Budget
• - Administration Waiver Requests
• - Cost sharing Letter of Justification
• - Conflicts of Interest Certification - IRB
  Approval, Assurances
• Affiliate Site Approval

CPHS is provided- Application- Protocol-
Informed Consent - IRB Fee Billing Information -
Conflicts of Interest Certification - Letters of
Approval - Recruitment Material - HIPAA Form (if
indicated)
INSTITUTIONAL RA
Research Approved
Research NOT Approved
Budget/ Agreement/ Assurances Approved
Budget/ Agreement/ Assurances NOT Approved
Institutional Approvals Complete
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Where do we Start?

• Budget Development
• Refer to study flow chart look at the schedule
  of study activities and determine required
  research services
• Using internal budget template, list all of the
  items/services required for study on the budget
  grid
• Determine financial responsibility for all
  research services designate as standard of care
  (SOC) or contract/grant (C)
• Determine all study costs technical component,
  professional component
• Negotiate budget (contracts)

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Now What?

• After budget is final, complete Review and
  Approval Form
• Obtain departmental signatures
• Submit internal budget with Review and Approval
  Form and other required documents to Office of
  Sponsored Projects
• Establish UT research billing account for UTP
  professional fees and services to be paid by the
  research grant or sponsor

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UTHSC-H Clinical Trials Study Initiation Flowchart
STUDY ACCOUNT SET UP PROCESS

• PAF Team
• Establishes UT Study Account
• Receives Institutional Approval
• Receives list of Allowable Research Charges

• UT Physicians Billing Department
• Establishes Research Study Case Account
• Research Coordinator
• Completes Research Account Set Up Form
• - Department/ PI/ Coordinator
• - CPHS Number, Title, Sponsor
• List of allowable Research services, CPT codes,
  and charges

External Billing Account Set Up - At Affiliate
Site
MHH/HCHD/SLEH Approvals
For IDX, Research Coordinator Transmit -
Research Account Set Up Form - Short Overview of
Protocol to 1. Case Billing Department FAX
713-500-8144 Email Monica.Horace_at_per-se.com
Phone [phone] and 2. Specific UCP
Clinic Physician Office Administrator
PAF Team Sends Account Notification to
PI/Department/ OSP
STUDY INITIATION
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UT Research Billing Account

• For all UTP professional fees and all
  services performed in UTP clinics billed to
  clinical study/grant ( not SOC)
• Research Coordinator facilitates account set-up
• Complete Research Account Set-up Form
• http//www.uth.tmc.edu/research/templates/Research
  AccountSetupForm.xls
• Obtain CPT codes for services (from clinic
  charge
• document/ administration)
• Obtain price for UT services from UT Research
  Price List http//www.uth.tmc.edu/research/clini
  cal/

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UT Research Billing Account

• Describe subject population on Research Account
  Set- up Form
• DMO may sign off Research Account Set-up
• Form
• Transmit to
• Monica.Horace_at_per-se.com
• Case Billing Department
• Fax [phone]
• Phone [phone]
• Transmit Research Account Set-up Form to
• specific UCP Clinic Physician Office
  Administrator

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UTHSC-H Clinical Trials Study Administration
Flowchart
RESEARCH BILLING PROCESS
Generates Standard of Care Charge
Generates Research Charge
Patient Consented and Scheduled for UT Service
Research Service is Standard of Care and/or
Billable to Patient/ third Party - Schedule as
Standard Treatment

• Research Service Billable to Research Study
• Schedule as Research Service , set up Case
  Account

OUTPATIENT- Coordinator -Complete UT Clinical
Trial Services Form -Transmit Service Form to UT
Clinic Billing Specialist -Place copy in site
study file

• INPATIENT/HOSPITAL CLINIC - Coordinator
• Complete MHH Research Subject and Notification
  Form
• Transmit to UTHSC Billing dept.-each week
• Transmit to MH Research office each week
• Place copy in study file

For UT Physicians Professional Fee/Service
IDX -Generates Bill for Research Services
MHH -Generates statement for Hospital Research
Services

• PI/Research Coordinator
• Reconciles/corrects Research Services, charges
• -Generates Invoice to Sponsor per Study
  Compensation Schedule

Research Coordinator -Transmits Correct Bill to
PAF for Payment to Clinic/External Billing System
from Study Account

• PAF Team Study Account
• -Receives Revenue from Sponsor
• Pays IDX and/or External Billing System for
  Research Related Charges
• -Allocates Funds From Research Account for Study
  Effort

PI/ Study Coordinator/Staff Receive Compensation
for Study Effort
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UT Research Billing Process

• Coordinator
• Consent and schedule patient for UT service
  (billable to research study)
• Complete UTHSC-H Clinical Trial Services Form/
  Charge Document, (utilizing CPT code from Account
  Set-up Form)

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UT Research Billing Process

• Indicate visit date and research account number
  on Clinical Trial Services/ Charge Document Form
• Transmit Clinical Trial Services Form to clinic
  staff or department billing staff prior to (if
  known)/or when research services billable to the
  research study are performed establishes case
  account for subject (or transmit to Monica Horace
  to set up case account)
• Place copy of Form in study file

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Clinical Trials Services Form Charge Document
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UT Professional Fees/ Services performed at
affiliate hospitals clinics

• Complete UTHSC-H Clinical Trial Services Form/
  Charge Document, (utilizing CPT code from Account
  Set-up Form)
• Indicate service date, research account number,
  and subject case account number on Clinical Trial
  Services/ Charge Document Form
• Transmit Clinical Trial Services Form/Charge
  Document to deaprtment or clinic staff who enters
  charge in billing system
• Place copy of Form in study file

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Why is this Important?

• If a bill is submitted in error to Medicare or
  Medicaid and is paid, this constitutes a False
  Claim
• False claims are punishable by law
• If a bill is submitted to a third party payer
  and is paid AND the sponsor reimburses for the
  same service, this is double dipping and
  constitutes Fraud
• Fraud is punishable by law

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Financial Management

• It is important to communicate with administrator
• Set up schedule for communicating research
  visits/items and services performed
• Review CTA payment schedule milestone payments
• Review UT study account at least monthly has the
  start up money been received in the account, is
  payment schedule being followed, is there money
  in the account to cover the bills?
• Set up study ledger (billing grid)
• Includes all visits, each charge for visits
• Can be listed as visit 1 and total reimbursement
  for that visit

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Financial Management

• Review all statements
• Reconcile statements with study visit schedule
  is this the correct research charge for the
  service? Does this charge go with this study?
• Reconcile reimbursement from sponsor with CTA
  budget
• Prepare invoices if reimbursement payments are
  outstanding or separate invoicing is required for
  certain services refer to CTA budget
• Be sure to calculate and add indirect costs to
  invoice total this total should be in CTA budget

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Financial Management

• Key to the success of the trial
• Detailed tracking of the subjects activities
• Communicate with administrator

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Questions?

• Thank you very much!