Transcript Project Kick-Off

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
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Directors/Principal Investigators
Sub-Committee
Budgeting
Contracts
Financial Set Up
Clinical Delivery (Logistical)
Billing
Financial Tracking
Directors/P. I./Sub-Committee
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Study Procurement (P.I.s, Directors,
Coordinators)
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Study Evaluation (Directors, P.I., Coordinator)
 Determine Patient Population
 Clinical Merits
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Multi-Disciplinary Sub-Committee Approval
Budgeting/Contracts/Financial Set-up
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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-up
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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-up
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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-up
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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-up
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Budget/Contract Negotiations
 Allow enough time
 Know your limits
 Amicably negotiate
Budgeting/Contracts/Financial Set-up
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Financial Set-Up
 Medicare Approval
 Drug/Device Procurement
 Process for getting IDE on the Bill
 Set up Accounts
Clinical Delivery/Billing/Financial Tracking
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Clinical Delivery (Logistical)
Billing
Financial Tracking
Clinical Delivery/Billing/Financial Tracking
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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 Tracking
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Billing
 Account Holds
 Investigational Device Exemptions (IDEs)
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Account Review
Coding Routine Costs
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IDE Number in Item #23 on CMS-1500
QA Modifier for all services related to the IDE
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 Tracking
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Financial Tracking
 Database
 Payment Modeling
 Incoming Checks
 Outgoing Checks
 Invoicing Process
 Operational Analysis
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Revenue
Expenses
Statistics
QUESTIONS?
M. Paul Wade, Jr.
95 Collier Road, Suite 5005
Atlanta, Georgia 30309
(404) 605-2372
[email protected]