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Medicare Coverage Analysis at
The University of Southern California
Amanda C. RuelasMedicare Coverage Analyst
January 26, 2017
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• What?• Why?• When?• How?
Medicare Coverage Analysis
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• Identifies the services for which Medicare will pay under the Medicare Clinical Trial
Policy.
• Item of Billing Compliance
• The MCA lists all items and services to be provided as part of the clinical trial with
notations of what should be billed to the research sponsor and what can be billed to
Medicare.
• Notations are based on nationally recognized publications and other sources
What is Medicare Coverage Analysis?
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• Helps avoid compliance consequences with regard to
inappropriate billing.
• To ensure appropriate reimbursement for the services
provided to a patient in a clinical trial.
• Assists with Budget Build• Generates ROF
Why is an MCA Required?
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• Penalties• False Claims Act
Importance of Billing Compliance
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• Rush University Medical Center‐ $1 million settlement in 2005 for improperly billing services as routine costs under the Medicare Clinical Trial Policy.
• USC Norris Cancer Center‐ $1.9 million dollar settlement, billed for services paid by sponsor and billed for services in non‐ qualifying trial.
• University of Alabama‐ $3.39 million settlement for falsely billing Medicare for procedures also billed to the sponsor
• Emory University‐ $1.5 million settlement for falsely billing Medicare and Medicaid for clinical trial services that were not permitted.
Importance of Billing Compliance
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• Medical Intervention to Patient
• Bill will be dropped for Services (ROF)
• Study Team Time and Effort
When Is an MCA Required?
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• Clinical Trial• DCG negotiates contract and budget for non‐industry
• CTO negotiates contract and budget for industry
• CTO performs MCA review for all clinical trials regardless of funding source
CTO and DCG
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• Studies where MCA exemption may apply:• Compassionate Use• Data Collection
• MCA exemptions are determined by CTO Coverage analyst during Initial Review
MCA Exemptions
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How are MCAs performed at USC
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• Protocol• ICF• Budget• Lab Manual• Investigator Brochure • Contract• IDE/IND
Items required to Begin & Finalize MCA
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Determinations SOC vs Research
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• National Coverage Determinations “NCDs”• Local Coverage Determinations “LCDs”• University Policies & Guidelines
• PI provides input to SOC vs. RES at kickoff meeting
and signs MCA upon completion.
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QCT Checklist
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Requirements for Qualifying Clinical Trials• A qualifying clinical trial (QCT) is a trial that meets the requirements set forth in
Clinical Trial Policy (NCD 310.1) by the Center for Medicare and Medicaid Services (CMS).
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MCA and Calendar
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• Nimblify• Validation
Study Calendar
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• Study Submissions• CTU Services• Ancillary Committees• Labs / Shipment of Specimen• Pharmacy / Drug Accountability• Etc.
Information to Expedite Your Study
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• Oncore Support – [email protected]
• Oncore Submission – Talena Sanchez [email protected]
• Calendar ‐ Chris Ancheta [email protected]
• MCA – Maria Rios [email protected]
• Budget – Teresa Trejo [email protected]
• Contract – Sara Katrdzhyan [email protected]
• Billing – Nora Turrey [email protected]
CTO Contacts
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