Business Operations Pre-Award. What is required to begin the business process? Possible indicators CDA executed Cancer Center MDG/PRC approvals Department

Business OperationsPre-Award

What is required to begin the business process?

• Possible indicators• CDA executed• Cancer Center

• MDG/PRC approvals

• Department contacts business office

• Electronic Proposal Transmittal Form (ePTF)• What is it/what is it for?

• It is an electronic mechanism for Jefferson to manage, maintain, and approve research

• Used for all research at Jefferson

Electronic Proposal Transmittal Form (ePTF)What is needed?

• Materials required to complete (ePTF) for approval•Protocol•Investigator Brochure (IB)•Draft Informed Consent (ICF)•Clinical Trial Agreement (CTA)•Sponsor Budget

Electronic Proposal Transmittal Form (ePTF)What is the approval process?

• Clinical trials• First Round approval

• Contract/MCA/Budget • Process may begin

• Second round approval• MCA/Contract/Budget negotiated • IRB approval letter and informed consent

JCRI Business OperationsCoverage Analysis & Budget

Coverage Analysis

Materials needed to conduct a Coverage Analysis

From Study Team:•Same as (ePTF) process

• Protocol• Investigator Brochure (IB)• Draft Informed Consent (ICF)• Clinical Trial Agreement (CTA)• Sponsor Budget

•Approved electronic proposal transmittal form (ePTF)• First round only

What is a Coverage Analysis?

• Document that determines the appropriate payor (i.e. Sponsor, Medicare or third party payor) for each item and service required by a clinical research trial

Why is a Coverage Analysis important?

• Reduces risk for submitting false claims• Billing for services not part of a qualifying clinical trial• Billing for items and services promised/paid for by

Sponsor• Billing for research only items and services

• Assists in budget negotiations with Sponsor/CRO• Identifies costs that need to be accounted for in the

sponsor budget

• Basis of billing compliance/audits • Provides evidence of due diligence and a mechanism for

compliance with billing rules

Coverage Analysis Process

• Receive all materials from the study team • Create a grid that reflects all clinical events and time

points in the protocol• Review clinical guidelines along with CMS national and

local coverage determinations to identify the appropriate payor for each event

• Send the CA to PI/SC for review and approval• Approve or revise the CA as necessary

Day 1 Day 8Day 15

Day 22

Day 43Day 50

Day 57

Day 64

N/A No S This is not a billable item or service.N/A No S This is not a billable item or service.N/A No S This is not a billable item or service.N/A No S S S S S S S S S This is not a billable item or service.N/A No S S S S S S S S S This is not a billable item or service.

99201 - 99205; 99211 - 99215

G0463

Q1 M M M According to the NCCN Clinical Practice Guidelines in Oncology Multiple Myeloma Version 2.2014 "NCCN Guidelines" a physical exam is considered conventional care at workup (NCCN Guidelines, p. 6). Patients in this trial have a confirmed diagnosis of relapsed/refractory multiple myeloma after treatment with at least two different previous regimens. Prior treatment must include at least two standard anti-myeloma therapies or induction therapy followed by autologous stem cell transplant (Protocol, p. 23). The study drug given in this trial has unknown side effects. A physical exam at screening, once per cycle and at response assessments appear reasonable and necessary for the clinical management of the patient in order to monitor disease progression and potential side effects. Coverage supported by NCD 310.1.

N/A No NA NA NA NA NA NA NA NA NA This is a bundled service, and is not billable.

N/A No NA NA NA NA NA NA NA NA NA This is a bundled service, and is not billable.

N/A No NA This is a bundled service, and is not billable.

85025 or

85027 and 85007

Q1 M M M M M M M M M A CBC with differential is considered conventional care at initial workup (NCCN Guidelines, p. 6). The study drug, ALT-803, caused an increase in white blood cell counts in animal studies (Protocol, p. 18-19). Patients in this trial have multiple myeloma which also affects blood counts. CBC testing throughout treatment appears to be done both for the clinical management of the patient and to monitor, assess and treat for potential complications associated with the study drug. Coverage supported by NCD 310.1 and NCD 190.15.

80053 Q1 M M M M M M M M M The study drug, ALT-803, caused a decrease in total protein and albumin levels in the blood, as well as decreased blood calcium levels in animal studies (Protocol, p. 18-19). CMP testing throughout treatment appears to be done both for the clinical management of the patient and to monitor, assess and treat for potential complications associated with the study drug. Coverage supported by NCD 310.1.

93000 - 93010 No S S S The study drug does not appear to have cardiac side effects, and states that "no dose related abnormalities based on ECG or ophthalmic evaluations were

J9999 Q0 NB NB NB NB NB NB NB NB The study drug will be provided by the sponsor. The protocol states: "ALT-803 is an investigational drug supplied to investigators by the Altor Bioscience Corporation at Miramar, Florida. Sufficient study drug will be available for this protocol to treat all of

96365-96368 Q1 M M M M M M M M IV administration of the study drug is supported by NCD 310.1.

Study Medications

Comprehensive Metabolic Panel

Medical History

Time & Effort

Concomitant MedicationsAdverse Event Assessment

Evaluation & Management Services

Vital Signs

Complete Physical Exam

M: Medicare or Other Heath PlanS: Charged to Study Fund or SponsorNA: Bundled With Another Payment From Third PartyNB: Not Billed to Anyone, Not a Billed Event, No CPT Code

ALT-803 (IV)

Scans/Procedures

CBC with Differential

Electrocardiogram (EKG)

Coverage Code Key

Informed ConsentInclusion/Exclusion Criteria

Comments

IV Infusion (ALT-803)

Labs

Weight

Height

Items and ServicesCPT/HCPCS

Codes Q1/Q0 Mod

Screening1 Month 1

Cycle 1

Month 2

Cycle 2

Clinical Trial Budget

Develop a financial plan that encompasses all phases of the study:

• Start-up costs• Institutional costs• Other costs incurred throughout the study• Subject costs


• Start-up costs• training, meetings, IRB/regulatory work, source document

creation

• Institutional costs• Other costs incurred throughout the study• Subject costs

Start-Up Costs

Activity Charge Hours PI hours RC hoursStudy Feasibility Assessment (database review, medical records, recruiting/advertising preparation) 525.41$ 8.00 1.6 6.4Site Qualification Visit preparation and attendance 247.23$ 4.50 0.45 4.05Regulatory Documents Preparation, Submission, Collecting Signatures (FDA 1572, CVs, W9, etc) 933.99$ 17.00 1.7 15.3IRB Documents Preparation, Submission, Collecting Signatures, Queries (Proposal Transmittal, Informed Consent, etc) 836.11$ 16.00 1.2 14.8Source Document Creation 1,326.15$ 30.00 0 30.00Site Initiation Visit preparation and attendance 604.35$ 11.00 1.1 9.9PI Staff Meetings, Training, Hiring, Communications 520.51$ 10.50 0.525 9.975Total admin start up 4,993.74$ 97.00 6.575 90.425Hourly Rate + 26.3% fringe Hourly w/ FringePI (weekly salary / 40 hours) 120.00$ 151.56 Research Coordinator (weekly salary / 40 hours) 35.00$ 44.205



creation

• Institutional costs• F&A, IRB fees, billing compliance fees

• Other costs incurred throughout the study• Subject costs



creation

• Institutional costs• F&A, IRB fees, billing compliance fee

• WIRB/Quorum – One time fee $2,500

• Other costs incurred throughout the study• site monitor fees, IRB work on continuing reviews or

amendments, dry ice, close-out costs, etc.

• Subject costs

Other Costs

Recruitment Reconsent Fee Pharmacy Start Up Amendment Administrative FeePharmacy Monthly Maintenance Study Close-OutPharmacy Close Out Document Storage

IRB Submission Work on Continuing and Ammendments Site Monitor Visit FeeUAE Submission to IRB (FDA required 24-48 hours) Sponsor/FDA auditIND Safety Reports (Per Report) Dry IceAdvertising Equiptment/Supplies



creation

• Institutional costs• F&A, IRB fees, billing compliance fee

• WIRB/Quorum – One time fee $2,500

• Other costs incurred throughout the study• site monitor fees, IRB work on continuing reviews or

amendments, dry ice, close-out costs, etc.

• Subject costs• Any items that are not billable to insurance or provided

by the sponsor

Day 1 Day 8Day 15

Day 22

Day 43Day 50

Day 57

Day 64

N/A $150 $150 $150N/A $100 $100 $100N/A $75 $75 $75N/A $50 $50 $50 $50 $50 $50 $50 $50 $50 $50 $450N/A $50 $50 $50 $50 $50 $50 $50 $50 $50 $50 $450

99201 - 99205; 99211 - 99215

G0463

Q1 M M M M

N/A No NA NA NA NA NA NA NA NA NA NA

N/A No NA NA NA NA NA NA NA NA NA

N/A No NA

85025 or

85027 and 85007

Q1 M M M M M M M M M M

80053 Q1 M M M M M M M M M M

36415 or 36592 Q1 M M

93000 - 93010 $130 $130 $130 $130 $390

J9999 No NB NB NB NB NB NB NB NB

96365-96368 Q1 M M M M M M M MN/A $150 $150 $150 $150 $150 $150 $150 $150 $150 $150 $1,350

N/A $150 $150 $150 $150 $150 $150 $150 $150 $150 $150 $1,350$855 $530 $400 $400 $400 $530 $400 $400 $400 $4,315$257 $159 $120 $120 $120 $159 $120 $120 $120 $1,295

$1,112 $689 $520 $520 $520 $689 $520 $520 $520 $5,610

Concomitant MedicationsAdverse Event Assessment

Vital Signs

Comprehensive Metabolic Panel

Medical History

Time & Effort

Complete Physical Exam

Venipuncture

Month 2

Cycle 2

Cost Screening1 Month 1

Cycle 1

Indirect Rate 30%Total Costs

Total

IV Infusion (ALT-803)

Weight

Height

Items and ServicesCPT/HCPCS

Codes

Informed ConsentInclusion/Exclusion Criteria

PI

Study CoordinatorTotal Direct Costs

ALT-803 (IV)

CBC with Differential

Electrocardiogram (EKG)

Accomplished by considering all stakeholders input:

• PI and Study Coordinator • Radiology • Pathology• Pharmacy• Hospital Billing• Professional Services Billing• Other departments• Sponsor

Clinical Trial Agreement

What is required to complete a contract?

• Who wrote the protocol?• Sponsor

• Clinical Trial Agreement

• PI/Jefferson • Investigator Initiated Agreement

• Is the sponsor contract new or previously negotiated?• If new – review/red line changes

• Forward to legal

• If previously negotiated – similar protocol• Review/red line changes

• Forward to sponsor


• Negotiate terms• Ensure budget, billing and payment terms are acceptable• Is the IRB approved?

• Approval letter and informed consent reviewed• Sponsor and protocol must match contract

• Subject injury and indemnification language• Different terms in each but intent must be the same

• (ePTF) secondary approvals


• Execute • Forward to PI • Return to sponsor

• PDF or mail

• Account set up• Establishment letter to staff and accounting• MCA includes account number sent to staff and billing

Post Account Establishment

• Modifications/Amendments• No cost extension• Change in PI• Modification to protocol

• No budget modification

• Modification to protocol• Budget modification

• $5,000 or greater• (ePTF) supplement • Approvals, etc.

• Follow same SOPs as a new clinical trial

How to initiate the process

Please, please, and please reach out to your clinical research administrator for more information. •Ronald Polizzi, Director, Business Operations JCRI, 3-2127•Michael Caggiano, Team Lead, 3-4746•Jennifer Lott, Team Lead, 5-2546•Jenny Campbell, Clinical Research Administrator, 3-4282•LouEllen Daniel, Clinical Research Administrator, 3-5390•Ryan Massimilla, Clinical Research Administrator, 3-2890•Mary Rose Taft, Clinical Research Administrator, 3-4265