Making the Most of your Budget: Hidden Costs and Payment Terms
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1 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
2 Presentation Overview Timing Basic budget build overview Hidden costs Payment terms General negotiation tips
3 Administrative Cycle of Events Study Document Review Sync Review Perform Coverage Analysis (CA) Negotiate Budget and CTA until Final Develop Initial Budget Redline Clinical Trial Agreement (CTA)
4 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
5 Dissecting the Protocol Review the protocol, lab manual and ICF to understand the visits and study complexity Schedule of events Procedures and assessment descriptions What else is required that is not listed (i.e. pathology and processing for biopsy)? Visit details Laboratory requirements
6 General Budget Considerations Type of Study Adult versus pediatrics trial Treatment versus prevention versus observation Inpatient versus outpatient Length of Study Follow up required multiple visits? Long term? Patient visit requirements Complexity Resources Needed Recruitment challenges Patient requirements (i.e., intensive PKs, diaries, testing) Level of staff and/or patient training Increased personnel time Additional or special testing needs Extensive data requests
7 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 ( 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
8 Categorize the Budget Components Direct Costs Indirect Costs Invoice Items Study personnel (e.g., labor) Tests/procedures (i.e., services that generate bills, regardless of the payer source) Operating expenses (e.g., phones, faxes, copying) Institutional expenses (e.g., support services, space, IT, HR) Driven by Institutional policy Infrastructure within the unit (i.e., study team make-up, management) Subject travel, lodging, meals, parking reimbursement Record archiving Subcontractor payments
9 Budget Costs: Getting Started IRB Fees 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. Admin 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. When calculating your cost to start up a study, include all of your beginning expenses Ancillary Start up Fees Radiology, pharmacy, laboratory, etc. Can include protocol review, budget preparation, study start up/study initiation meetings, drug data sheet development and creation of orders by these ancillary service providers
10 Hidden Cost Categories 1. Patient Care Costs 2. Invoiceables 3. Administrative Fees
11 Evaluation/Management Hidden Costs Room Fees Observational Periods
12 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
13 Central Lab Hidden Costs Shipping Dry Ice Processing Storage PK multiple draws Room fees Coordinator time Venipunctures
14 Hidden Imaging Costs RECIST, RANO, Chenson, etc Contrast agents Personnel time for procedures Image duplication Central imaging reads
15 Hidden Procedural Costs Anesthesia OR Time/Room fees Overnight stays ICU fees Personnel time for procedures Biopsies Invoice amount vs. actual amount
16 Hidden Drug Costs Pharmacy dispensing Drug accountability Administration of the drug Special supplies (flushes, bags, tubing, pumps) Storage requirements Supportive measures
17 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?
18 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
19 Hidden Start-Up Costs Departmental Start-Up Fees Pharmacy Radiology Lab/Pathology
20 Ongoing Administrative Fees Admin submission fees IRB Amendments Monitoring Audits
21 Hidden Close-Out Fees Storage Number of years required Price per square foot Drug destruction or return Destroy on site Ship back to sponsor
22 Hidden Study Coordinator Costs Overtime On-call time Studies with home health Studies with extensive coordinator activity
23 Hidden Pass-Through Costs Vendor Fees IRB fees Contractors or third party vendors Equipment purchase costs
24 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
25 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
26 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
27 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
28 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
29 Thank you! Feel free to contact us directly if you have any further questions: Alex Opitz Lead Clinical Research Analyst PFS Clinical (608) x 2254 Amanda Miller Lead Clinical Research Analyst/Training Program Manager PFS Clinical amiller@pfsclinical.com (608) x 2263
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This is only a summary. If you want more detail about your coverage and costs, you can get the complete terms in the policy or plan document at www.healthplan.memorialhermann.org or by calling 1-888-594-0671.
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This is only a summary. If you want more detail about your coverage and costs, you can get the complete terms in the policy or plan document at www.crystalrunhp.com or by calling 1-844-638-6506. Important
You don t have to meet deductibles for specific services, but see the chart starting on page 2 for other costs for services this plan covers.
This is only a summary. If you want more detail about your coverage and costs, you can get the complete terms in the policy or plan document by calling 1-866-497-5711. Important Questions Answers Why this
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