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Managing Research Finances: Successful Strategies for Viability and Compliance. July 29, 2006 M. Paul Wade, Jr., MS Financial and Contracts Compliance Officer. Elements of Clinical Research. Clinical. Regulatory. Operations. Operational Structure. Directors/Principal Investigators

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managing research finances successful strategies for viability and compliance

Managing Research Finances:Successful Strategies for Viability and Compliance

July 29, 2006

M. Paul Wade, Jr., MS

Financial and Contracts Compliance Officer

elements of clinical research
Elements of Clinical Research

Clinical

Regulatory

Operations

operational structure
Operational Structure
  • Directors/Principal Investigators
  • Sub-Committee
  • Budgeting
  • Contracts
  • Financial Set Up
  • Clinical Delivery (Logistical)
  • Billing
  • Financial Tracking
directors p i sub committee
Directors/P. I./Sub-Committee
  • Study Procurement (P.I.s, Directors, Coordinators)
  • Study Evaluation (Directors, P.I., Coordinator)
    • Determine Patient Population
    • Clinical Merits
  • Multi-Disciplinary Sub-Committee Approval
budgeting contracts financial set up
Budgeting/Contracts/Financial Set-up
  • Standard of Care (SOC) vs. Non-Standard of Care (nSOC) Review
  • Budget Development
  • Contract Review
  • Budget/Contract Negotiations
  • Financial Set-Up
budgeting contracts financial set up1
Budgeting/Contracts/Financial Set-up
  • Standard of Care (SOC) vs. Non-Standard of Care (nSOC) Review
    • Billing Compliance
    • P.I./Study Coordinator Review

In September of 2000 CMS issued a final coverage decision for Medicare to cover the routine health care costs of beneficiaries in clinical trials.

The rules for billing standard of care to research patients is subject to varying interpretations. Therefore, BE CONSISTENT IN YOUR PROCESSES.

budgeting contracts financial set up2
Budgeting/Contracts/Financial Set-up
  • Budget Development
    • Start-Up Costs (Administrative, Regulatory, etc.)
    • IRB Fees
    • Pharmacy Fees
    • Coordinator Time/Overhead
    • Device/Drug
    • CPT codes for nSOC Labs, Tests and Procedures
    • Screen Failures
    • Unpaid Insurance Claims
    • File Storage
budgeting contracts financial set up3
Budgeting/Contracts/Financial Set-up
  • Contract Review – Important Elements
    • Determine the parties
    • Study Description/Protocol Exhibit/FDA approval
    • Terms are well defined
    • Performed in strict compliance with the protocol
    • Anti-kickback, Anti-fraud language
    • Indemnification/Insurance/Adverse Outcomes
    • HIPAA
    • Mutual Confidentiality
    • Data Ownership
    • Publications
    • Inventions/Intellectual Property
    • Termination
budgeting contracts financial set up4
Budgeting/Contracts/Financial Set-up
  • Budget/Contract Negotiations
    • Allow enough time
    • Know your limits
    • Amicably negotiate
budgeting contracts financial set up5
Budgeting/Contracts/Financial Set-up
  • Financial Set-Up
    • Medicare Approval
    • Drug/Device Procurement
    • Process for getting IDE on the Bill
    • Set up Accounts
clinical delivery billing financial tracking
Clinical Delivery/Billing/Financial Tracking
  • Clinical Delivery (Logistical)
  • Billing
  • Financial Tracking
clinical delivery billing financial tracking1
Clinical Delivery/Billing/Financial Tracking
  • Clinical Delivery (Logistical)
    • Communication (Depts., CRCs, Regulatory and Finance)
    • Drug/Device
    • Communicating Enrollments
    • Inter-office/facility communication (collaboration with outside entities)
clinical delivery billing financial tracking2
Clinical Delivery/Billing/Financial Tracking
  • Billing
    • Account Holds
    • Investigational Device Exemptions (IDEs)
      • IDE Number in Item #23 on CMS-1500
      • QA Modifier for all services related to the IDE
    • Account Review
    • Coding Routine Costs
      • QV modifier on line item level (outpatient only)
      • Diagnosis code V70.7 reported as the secondary or subsequent diagnosis
    • Trial Name, Sponsor and Protocol number if applicable and requested
    • Periodic Audit for Billing Compliance
clinical delivery billing financial tracking3
Clinical Delivery/Billing/Financial Tracking
  • Financial Tracking
    • Database
    • Payment Modeling
    • Incoming Checks
    • Outgoing Checks
      • Invoicing Process
    • Operational Analysis
      • Revenue
      • Expenses
      • Statistics
questions
QUESTIONS?

M. Paul Wade, Jr.

95 Collier Road, Suite 5005

Atlanta, Georgia 30309

(404) 605-2372

[email protected]

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