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Coverage Analysis (CA) Intro to CA at DGSOM at UCLA Hl O JD Helene Orescan, J.D. Bishoy Anastasi, MBA, CCRP David Geffen School of Medicine at UCLA David Geffen School of Medicine at UCLA Industry Sponsored Clinical Trials March 8, 2012 1

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Page 1: Coveraggy()e Anal ysis (CA) - Research | UCLA)e Anal ysis (CA) Intro to CA at DGSOM at UCLA Hl O JDHelene Orescan, J.D. Bishoy Anastasi, MBA, CCRP David Geffen School of Medicine at

Coverage Analysis (CA) g y ( )Intro to CA at DGSOM at UCLA

H l O J DHelene Orescan, J.D. Bishoy Anastasi, MBA, CCRP

David Geffen School of Medicine at UCLADavid Geffen School of Medicine at UCLAIndustry Sponsored Clinical Trials

March 8, 20121

Page 2: Coveraggy()e Anal ysis (CA) - Research | UCLA)e Anal ysis (CA) Intro to CA at DGSOM at UCLA Hl O JDHelene Orescan, J.D. Bishoy Anastasi, MBA, CCRP David Geffen School of Medicine at

Wh t i C A l i ?What is Coverage Analysis?Coverage Analysis documents the process of identifying procedural costs which may be g y p y g p ybilled to an insurer as “routine care” vs. research costs for procedures/services provided as a result of participation in a “qualified” clinical trial.

• Routine Care (RC) – Billable to Insurer• Provided to patients absent a clinical trial.• Required for administration of investigational item.• Necessary for subjects’ safety (clinical monitoring), or prevention of complication(s)• Medically necessary for diagnosis or treatment of complications arising from administration

of investigational item.

• Research Costs Must be provided for by Sponsor or other Funding Source• Research Costs – Must be provided for by Sponsor or other Funding Source• All other procedures/services• Must be provided by sponsor or another source of funding/support (NIH, Foundation, Grant,

Internal Research Funds, etc.).

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Page 3: Coveraggy()e Anal ysis (CA) - Research | UCLA)e Anal ysis (CA) Intro to CA at DGSOM at UCLA Hl O JDHelene Orescan, J.D. Bishoy Anastasi, MBA, CCRP David Geffen School of Medicine at

R ti C C t D NOT I l dRoutine Care Costs Do NOT Include:

• The Investigational Item or Service, unless otherwise covered absent the clinical trial.

• Items/services provided solely for data collection and research analysis (not used in the direct y (clinical management of subjects).

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Page 4: Coveraggy()e Anal ysis (CA) - Research | UCLA)e Anal ysis (CA) Intro to CA at DGSOM at UCLA Hl O JDHelene Orescan, J.D. Bishoy Anastasi, MBA, CCRP David Geffen School of Medicine at

C A l i Wh i Q lif i T i l?Coverage Analysis – What is a Qualifying Trial?Must meet all of the following criteria to be considered a “qualifying trial”:

Evaluates a Medicare benefit – item /service falls within a Medicare Benefit category and 

is not statutorily excluded from coverage (e.g.  cosmetic surgery, hearing aids); andis not statutorily excluded from coverage (e.g.  cosmetic surgery, hearing aids); and

Has therapeutic intent – i.e. not designed exclusively to test toxicity/pathology; and

Enrolls diagnosed beneficiaries – enroll patients with diagnosed disease rather than only 

( )healthy volunteers (but may also enroll a healthy control group); and 

Has desirable characteristics:

Trials funded by NIH, CDC, AHRQ, CMS, DOD and VA; ory

Trials supported by centers or cooperative groups funded by same (above); or 

Trials conducted under an IND reviewed by the FDA; or 

d (b)( ) IND exempt under 21 CFR 312.2(b)(1)

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Page 5: Coveraggy()e Anal ysis (CA) - Research | UCLA)e Anal ysis (CA) Intro to CA at DGSOM at UCLA Hl O JDHelene Orescan, J.D. Bishoy Anastasi, MBA, CCRP David Geffen School of Medicine at

Why do we NEED to perform CA?!Why do we NEED to perform CA?!Medicare September 2000 – National Coverage Decision (NCD)September, 2000 National Coverage Decision (NCD)

Provides coverage for Medicare beneficiaries participating in clinical trials for “usual” or “conventional care”

2005 – Rush Settles with Federal Government for $1 Million$

October, 2007 – Medicare Clinical Trials Policy (CTP) NCD + clarifications Provides expanded coverage for “qualified” clinical trials Provides expanded coverage for qualified clinical trials Requires identification of all “billable” study procedures/services, regardless if “usual”

or routine care.

January 2008 – New Billing Codes Issued for clinical trialJanuary 2008 New Billing Codes Issued for clinical trial coverage.

UCOP

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2010 UCOP Requires all UC medical centers to implement a system of Clinical Research Billing Compliance.

Page 6: Coveraggy()e Anal ysis (CA) - Research | UCLA)e Anal ysis (CA) Intro to CA at DGSOM at UCLA Hl O JDHelene Orescan, J.D. Bishoy Anastasi, MBA, CCRP David Geffen School of Medicine at

CA Eli i D bl Di iCA Eliminates Double‐DippingRecent False Claims Settlements:

• Yale University $7 6MYale University $7.6M• Mayo Clinic $6.5M• Medical College of Georgia $6.1Mg g• Northwestern University $5.5M• UCSD $4.7M

C ll i i $4 3• Cornell University $4.3M• Johns Hopkins $2.6M

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Page 7: Coveraggy()e Anal ysis (CA) - Research | UCLA)e Anal ysis (CA) Intro to CA at DGSOM at UCLA Hl O JDHelene Orescan, J.D. Bishoy Anastasi, MBA, CCRP David Geffen School of Medicine at

CA Rollout at UCLACA Rollout at UCLA• Study Feasibility Performed• Budget Development (all protocol required procedures

identified)• Identify any “Routine Care” (RC) procedures/services.y y ( ) p

• If no RC, Coverage Analysis is not required. All procedures/services must be provided by sponsor or another funding source.

• If RC identified, is this a “qualifying” clinical trial? • If not “qualifying”, all procedures/services must be provided

by sponsor or another funding source.y p g• If a “qualifying” CT, determine which RC costs are eligible for

reimbursement from insurer.

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Page 8: Coveraggy()e Anal ysis (CA) - Research | UCLA)e Anal ysis (CA) Intro to CA at DGSOM at UCLA Hl O JDHelene Orescan, J.D. Bishoy Anastasi, MBA, CCRP David Geffen School of Medicine at

Coverage Analysis Decision TreeCoverage Analysis Decision TreeStudy Feasibility Performedy y

Budget Development (all procedures identified)

Identify any RC procedures/services

If no RC, CA not required. All costs paid for by Sponsor or other funding source

If RC identified, is this a “qualifying” CT? (CTCU checklist in development)

If it is a “qualifying” CT, determine which RC costs are billable to insurer

y p g ( p )

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which RC costs are billable to insurer

Page 9: Coveraggy()e Anal ysis (CA) - Research | UCLA)e Anal ysis (CA) Intro to CA at DGSOM at UCLA Hl O JDHelene Orescan, J.D. Bishoy Anastasi, MBA, CCRP David Geffen School of Medicine at

Vi i S h d l B d CAVisit Schedule – Budget – CA 

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Page 10: Coveraggy()e Anal ysis (CA) - Research | UCLA)e Anal ysis (CA) Intro to CA at DGSOM at UCLA Hl O JDHelene Orescan, J.D. Bishoy Anastasi, MBA, CCRP David Geffen School of Medicine at

Vi i S h d l B d CAVisit Schedule – Budget – CA 

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Page 11: Coveraggy()e Anal ysis (CA) - Research | UCLA)e Anal ysis (CA) Intro to CA at DGSOM at UCLA Hl O JDHelene Orescan, J.D. Bishoy Anastasi, MBA, CCRP David Geffen School of Medicine at

Documentation

• CTCU• Approves final CA and study budget.Approves final CA and study budget.• Maintains final CA and study budget with contract file.

St d T (PI’ R ibilit )• Study Team (PI’s Responsibility)• Must document the CA process.• PI will certify CA and study budget.• Supporting CA documentation must be maintained with study

records.• Study Teams should be prepared for an internal

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y p pcompliance audit.

Page 12: Coveraggy()e Anal ysis (CA) - Research | UCLA)e Anal ysis (CA) Intro to CA at DGSOM at UCLA Hl O JDHelene Orescan, J.D. Bishoy Anastasi, MBA, CCRP David Geffen School of Medicine at

Additional Resources UCLA Clinical Trials Website:

http://clinicaltrials.ucla.eduttp://c ca t a s.uc a.eduUsername: Password:

F  P i /C i For Patient/Community

For Faculty/Staff Contact usContact us

Please note:  Site access is limited to on‐campus IT ticonnections.

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Page 13: Coveraggy()e Anal ysis (CA) - Research | UCLA)e Anal ysis (CA) Intro to CA at DGSOM at UCLA Hl O JDHelene Orescan, J.D. Bishoy Anastasi, MBA, CCRP David Geffen School of Medicine at

ClinicalTrials ucla eduClinicalTrials.ucla.edu

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Page 14: Coveraggy()e Anal ysis (CA) - Research | UCLA)e Anal ysis (CA) Intro to CA at DGSOM at UCLA Hl O JDHelene Orescan, J.D. Bishoy Anastasi, MBA, CCRP David Geffen School of Medicine at

CTCU Distribution ListCTCU Distribution List• CTCU Workshops

• CT Budgets 101 – Intro to Industry CT Budget Development• CT Budgets 201 – Coverage Analysisg g y• CT Budgets 301 – Advanced Budgeting (Investigator-Initiated)

• Email Updates, Upcoming Forums, etc.

C SE d @ d l d• Contact: [email protected]

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Page 15: Coveraggy()e Anal ysis (CA) - Research | UCLA)e Anal ysis (CA) Intro to CA at DGSOM at UCLA Hl O JDHelene Orescan, J.D. Bishoy Anastasi, MBA, CCRP David Geffen School of Medicine at

Cli i l T i l C t t I fClinical Trials Contact Info

Helene Orescan, J.D.DirectorDGSOM Dean’s Office, Industry Clinical TrialsDGSOM Deans Office, Industry Clinical [email protected]‐794‐0137

Bishoy Anastasi, MPH, MBA, CCRPCRA SupervisorDGSOM Dean’s Office, Industry Clinical [email protected]‐794‐0545

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Page 16: Coveraggy()e Anal ysis (CA) - Research | UCLA)e Anal ysis (CA) Intro to CA at DGSOM at UCLA Hl O JDHelene Orescan, J.D. Bishoy Anastasi, MBA, CCRP David Geffen School of Medicine at

Q i ?Questions?

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