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Pharmaceutical Research Center (PRC) Fee Restructure (10.3)

Pharmaceutical Research Center (PRC) Fee Restructure (10.3) - Policies, Clinical, UWHC Clinical, Department Specific, Pharmacy, Pharmaceutical Research Center

10.3

POLICY & PROCEDURE





Effective Date:

August 2002

 Pharmacy Policy Manual
Chapter: Pharmaceutical
Research Center
Operations Procedure Manual
Chapter:

Policy #: 10.3

Original
 Revision 09/14
Page 1
of 3
Title: PHARMACEUTICAL RESEARCH
CENTER FEE RESTRUCTURE


I. PURPOSE: To establish procedures for determining Pharmaceutical Research Center (PRC)
fees and Pharmacy preparation/dispensing fees associated with clinical drug research protocols
and the mechanism by which such fees will be collected.

II. POLICY: This policy will establish the mechanism for calculating and securing all pharmacy
and PRC fees associated with handling and/or coordinating investigational/study drugs.

III. PROCEDURE:
A. Mechanism for determining Pharmacy drug dispensing/preparation fees for
investigational/study drug protocols
1. Dispensing, preparation and other applicable drug and/or handling procedures or
charges will be calculated per patient or per dispensing/preparation using the
Pharmaceutical Research Center Fee Schedule for the current fiscal year.
2. The PRC has the authority to negotiate customary pharmacy fees on a per study
basis.
3. Payment of pharmacy supplies and/or study drug handling, dispensing, and/or
preparation fees.
a. If sponsor is pharmaceutical industry, the PRC will assess
Pharmacy/PRC fees associated with study against the study grant.
b. If governmental study, the PRC will assess the core grants ability to pay
for Pharmacy/PRC fees.
c. In the event a sponsor does not cover pharmacy fees, such fees may be
waived or forwarded to the patient or patient’s third party insurer if
appropriate.
i. When applicable, the PRC will work with the UW Health
Research Billing Compliance Coordinator to ensure that
research billing compliance is maintained.
B. Mechanism for determining the PRC protocol fees for investigational/study drug
protocols.
1. PRC seeks reimbursement for two major protocol workload areas – Protocol
Activation and Storage/Maintenance. The estimated time, workload or expense
associated with each category is based on accumulated time studies and trend
analysis.
a. Protocol Activation – involves, but is not limited to: the establishment of
drug handling processes within the institution and clinics; verification of
Health Sciences Institutional Review Board approval status; creation of
a PRC protocol summary instructional document ; establishment of
pharmacy computer order entry codes enabling investigational/study

POLICY & PROCEDURE





Effective Date:

August 2002

 Pharmacy Policy Manual
Chapter: Pharmaceutical
Research Center
Operations Procedure Manual
Chapter:

Policy #: 10.3

Original
 Revision 09/14
Page 2
of 3
Title: PHARMACEUTICAL RESEARCH
CENTER FEE RESTRUCTURE

drugs to be entered on the patient’s computerized medication
administration record; creation of preprinted physician
orders/prescriptions (electronic or paper); creation of investigational
drug monograph; inservicing; establishment of drug procurement
procedures; creation of drug accountability records; randomization.
b. Storage/Maintenance: these activities take place and incur cost
regardless of the number patients enrolled, and therefore are not based
upon accrual.
i. Storage element - is primarily driven by the volume of the
space being occupied and is adjusted for the storage conditions
required (room temperature, refrigeration, frozen, satellite
involvement).
ii. Maintenance element - involves, but is not limited to: proactive
patient treatment date coordination with the study coordinator;
drug accountability recordkeeping; verification of minimum
inventory levels; drug ordering and drug shipment processing;
on-call study support for protocol questions; internal quality
assurance audits and inventory counts; sponsor audit
preparation and hosting; sponsor correspondences; changes of
protocol; study closure activities and record retention.
c. Other additional fees will be assessed as applicable and include, but are
not limited to: randomization fees; preparation of patient diary or
compliance cards; monitoring of therapeutic blood levels;
2. For industry sponsored studies and studies to which charges will be assessed the
PRC will seek reimbursement on an upfront and non-refundable basis (the amount
of which would cover activation fees and first quarter of storage and
maintenance) and quarterly basis until pharmacy close out (the amount of which
would cover estimated costs incurred with three months of storage and
maintenance).
3. For government sponsored studies for which no PRC fees will be assessed, the
PRC will verify fees covered via support of the PRC pharmacist salary in grant
(example: Phase I, ECOG, etc)
4. For Investigator initiated trials or other government sponsored trials, PRC will
seek reimbursement through the principal investigator or corresponding
department.
5. Upon completion of the PRC study budget estimate, a copy is forwarded to the
requesting physician/study coordinator and the Office of Clinical Trials. The
PRC budget is then incorporated into the overall study budget for contract
negotiations.

POLICY & PROCEDURE





Effective Date:

August 2002

 Pharmacy Policy Manual
Chapter: Pharmaceutical
Research Center
Operations Procedure Manual
Chapter:

Policy #: 10.3

Original
 Revision 09/14
Page 3
of 3
Title: PHARMACEUTICAL RESEARCH
CENTER FEE RESTRUCTURE

6. PRC manager is to be contacted in the event negotiations of the PRC budget are
requested.
C. Mechanism for collecting Pharmacy and PRC study fees.
1. PRC will collect fees associated with the study based on the final budget
negotiated.
2. Both Pharmacy and PRC fees will be billed and collected by the PRC via a work
order. All payments to the study/grant are to be sent c/o the investigator and
subsequently deposited into the study fund account.
3. The PRC Business Operations Specialist maintains a spreadsheet of all studies
requiring charges by the PRC based on either the study budget or the core grant
allocations. This spreadsheet is updated as new studies are activated by the PRC.
4. Upon activation by the PRC, the principal investigator/study coordinator is
notified that a work order needs to be established for the PRC in order to bill for
charges associated with the study. These charges are based on the study
budget/clinical trial agreement.
5. On a monthly basis, the spreadsheet, protocol budget, and drug accountability
records are reviewed. Based on the established budget, charges are then
processed to the study. Each protocol file contains a billing tracking document of
patient activity and charges assessed to the study/grant. A copy of the Statement
of Charges to Study spreadsheet is maintained in each protocol file which details
charging activity. A copy of this statement is e-mailed to the study coordinator
whenever charges are submitted to the grant.
6. Upon determination of charges to the study, a detailed monthly spreadsheet listing
the fund account number, work order number, physician/department, amount
charging the grant, and study name/number is e-mailed to UWHC Accounts
Payable and a copy retained in the PRC.
D. Mechanism for tracking use of sponsor supplied commercial product and/or use of
investigational product instead of formulary supplies.
1. PRC will track on a per unit basis (i.e., number of vials, capsules) commercially
available drugs that are provided by sponsors and/or have avoided use due to
study enrollment. The tracking database will also reflect the estimated unit costs
(either UWHC purchase price or average wholesale price if not a formulary item).



Approved By: ____________________________
Director of Pharmacy Services

Date: ____________