CTA Terms

Making the Most of your Budget:
Hidden Costs and Payment Terms

Presented by Amanda Miller and Alex Opitz
©2016 PharmaSeek Financial Services, LLC d.b.a. PFS Clinical, all rights reserved
Presentation Overview
• Timing
• Basic budget build overview
• Hidden costs
• Payment terms
• General negotiation tips
©2016 PharmaSeek Financial Services, LLC d.b.a PFS Clinical, all rights reserved
©2015 PharmaSeek Financial Services, LLC
Administrative Cycle of Events
Study Document
Review
Perform Coverage
Sync Review
Analysis (CA)
Negotiate Budget
Develop Initial
and CTA until
Budget
Final
Redline Clinical
Trial Agreement
(CTA)
Where do you Start?
• Obtain all essential documents pertaining to the trial:
• Protocol, lab manuals, informed consent (ICF)
• Contract and payment term documents
• Sponsor budget grid
• Review the protocol, lab manual and ICF with your
study team and the investigator
Dissecting the Protocol
Review the • Schedule of events

protocol, lab • Procedures and assessment descriptions
manual and ICF • What else is required that is not listed
to understand (i.e. pathology and processing for
the visits and biopsy)?
• Visit details
study • Laboratory requirements
complexity
General Budget Considerations
• Adult versus pediatrics trial
Type of Study • Treatment versus prevention versus observation
• Inpatient versus outpatient
• Follow up required—multiple visits? Long term?

Length of Study • Patient visit requirements
• Recruitment challenges
Complexity • Patient requirements (i.e., intensive PKs, diaries, testing)
• Level of staff and/or patient training
Resources • Increased personnel time

• Additional or special testing needs
Needed • Extensive data requests
Build your Budget
• Use your own template—build a study-specific budget from scratch based on the protocol
• Add all line items/procedures, assign costs, and frequencies
• Charge master or fee schedule—if you don’t know your site’s cost for a procedure/item,
be sure to ASK.
• If all else fails, Medicare rate times 3 or 4 is common (www.cms.gov).
• Don’t forget time and effort
• Include overhead
• Remember to include unscheduled and early termination visits
• Identify standard of care items as well as invoiceable items
• Calculate staff time
• Study Coordinator/Nurse fees
• Investigator cost
• Data entry fees
• Include Subject costs
• Stipend, travel, and lodging
Categorize the Budget Components
• Study personnel (e.g., labor)
• Tests/procedures (i.e., services that generate bills,
Direct Costs regardless of the payer source)
• Operating expenses (e.g., phones, faxes, copying)
• Institutional expenses (e.g., support services, space, IT,

HR)
Indirect • Driven by Institutional policy
Costs • Infrastructure within the unit (i.e., study team make-up,
management)
• Subject travel, lodging, meals, parking reimbursement

Invoice • Record archiving
Items • Subcontractor payments
Budget Costs: Getting Started
• Covers the cost of IRB review when using a local IRB
• Be sure to address ALL costs with a local IRB—annual review, protocol amendments, etc.
IRB Fees
• Covers the cost of regulatory document preparation, contract negotiation, budget development,
coordinator/research nurse start up time, investigator start up time, protocol review, source
document creation, training staff on the study, investigator meetings, etc.
Admin • When calculating your cost to start up a study, include all of your beginning expenses
Fees
• Radiology, pharmacy, laboratory, etc.

• Can include protocol review, budget preparation, study start up/study initiation meetings, drug data
Ancillary sheet development and creation of orders by these ancillary service providers
Start up
Fees
Hidden Cost Categories
1. Patient Care Costs
2. Invoiceables
3. Administrative Fees
Evaluation/Management Hidden Costs
Room Fees
Observational Periods
Local Lab Hidden Costs
Pathology
• Special prep and requirements
Send out labs

• Local labs that are processed/analyzed off-site
Lab certification requirements

• Does your local lab meet all the standards?
Venipunctures
• Don’t forget to include venipunctures in your budget
Central Lab Hidden Costs
• Shipping
• Dry Ice
• Processing
• Storage
• PK – multiple draws
• Room fees
• Coordinator time
• Venipunctures
Hidden Imaging Costs
RECIST, RANO, Chenson, etc
Contrast agents
Personnel time for procedures
Image duplication
Central imaging reads
Hidden Procedural Costs
• Anesthesia
• OR Time/Room fees
• Overnight stays
• ICU fees
• Personnel time for procedures
• Biopsies
• Invoice amount vs. actual amount
Hidden Drug Costs
• Pharmacy dispensing
• Drug accountability
• Administration of the drug
• Special supplies (flushes, bags, tubing, pumps)
• Storage requirements
• Supportive measures
Patient Care Invoiceable Items
• Alternate imaging options
• Items for specific patient populations (i.e.
pregnancy tests)
• Central labs
• Sub-studies
• Repeat labs
• Is overhead required on these items?
Items Hidden in the Protocol
• Items not in the schedule of events
• Examples:
• Extra scan location requirements
• Additional pregnancy tests
• Ultrasounds for positive pregnancy tests
Hidden Start-Up Costs
• Departmental Start-Up Fees
• Pharmacy
• Radiology
• Lab/Pathology
Ongoing Administrative Fees
• Admin submission fees
• IRB
• Amendments
• Monitoring
• Audits
Hidden Close-Out Fees
• Storage
• Number of years required
• Price per square foot
• Drug destruction or return
• Destroy on site
• Ship back to sponsor
Hidden Study Coordinator Costs
• Overtime
• On-call time
• Studies with home health
• Studies with extensive coordinator activity
Hidden Pass-Through Costs
• Vendor Fees
• IRB fees
• Contractors or third party vendors
• Equipment purchase costs
Payment Schedule
• Start-up payment should be non-refundable
• Advertising-when is this paid?
• When is start-up paid?
• Monthly versus Quarterly versus Milestone payments
• Requirements/timelines for receiving payments
• Invoices
• Know where to send
• Make sure invoiceables include overhead!
• Deadlines on submitting invoices
Other Payment Terms
• Language regarding standard of care items
• Make sure payee information is correctly entered
• Payment preferences (paper vs. electronic)
• Patient reimbursement/travel expenses and conditions
Final Payments and Holdback
• Make sure holdback percentage is reasonable (10% or less)
• Know the requirements for receiving final payment
• How does the sponsor define “end of study”?
• How long do you have to dispute payment discrepancies?
• Edit final payment/holdback terms as required
Tips for Negotiating Hidden Costs
• Don’t be afraid to educate the Sponsor/CRO!
• Be able to provide letterhead documentation
• Follow-up with sponsor/CRO to receive timely feedback
• Know what you can and cannot give up
General Timeline Considerations
• Balance between getting everything you want in the budget
or getting patients enrolled as soon as possible
• Competitive enrollment
• Number of potential patients
• Length of study
Thank you!
Feel free to contact us directly if you have any further
questions:
• Alex Opitz
Lead Clinical Research Analyst
PFS Clinical
aopitz@pfsclinical.com
(608) 664-9000 x 2254
• Amanda Miller
Lead Clinical Research Analyst/Training Program Manager
PFS Clinical
amiller@pfsclinical.com
(608) 664-9000 x 2263

CTA Terms

Hochgeladen von

Dokumentinformationen

Originaltitel

Copyright

Verfügbare Formate

Dieses Dokument teilen

Dokument teilen oder einbetten

Freigabeoptionen

Stufen Sie dieses Dokument als nützlich ein?

Sind diese Inhalte unangemessen?

Copyright:

Verfügbare Formate

CTA Terms

Hochgeladen von

Copyright:

Verfügbare Formate

Making the Most of your Budget:

Hidden Costs and Payment Terms

Review the • Schedule of events

• Follow up required—multiple visits? Long term?

Resources • Increased personnel time

• Institutional expenses (e.g., support services, space, IT,

• Subject travel, lodging, meals, parking reimbursement

• Radiology, pharmacy, laboratory, etc.

1. Patient Care Costs

Send out labs

Lab certification requirements

Personnel time for procedures

Central imaging reads

Das könnte Ihnen auch gefallen