Protocol Cost Savings Analysis

Protocol Cost Savings Analysis (PCSA) is a comprehensive review of the clinical procedures in a protocol, focusing on determining billable items under the Medicare Clinical Trial Policy (National Coverage Determination 310.1). By conducting a PCSA, our clients are able to offset R & D expenses by aligning protocol procedures with routine care since these expenses are reimbursed by governmental (i.e., Medicare) or private third-party payors. 

 

 

REALIZED SAVINGS

 
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BENEFITS

 
 
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Reduce per patient costs leading to a decrease in R&D expenses

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Enhance internal operational efficiencies resulting in cost savings

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Support routine care determinations with Medicare guidelines

 
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Harmonize key study documents to reduce the need for amendments

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Accelerate study start-up timelines due to improved processes

 

 

PCSA PROCESS

  • Participate in protocol development discussions to assist in aligning the study procedure schedule and objectives with routine care

  • Analyze draft protocol to determine if it is a qualifying clinical trial per Medicare guidelines and identify any additional cost savings

  • Develop study-specific inclusive, detailed activity grids and complete a coverage analysis of all procedures and tests outlined in the protocol by documenting routine care and research items using supporting Medicare rational for each determination

  • Review institution-specific justification of routine care to assist sponsor negotiations

  • Perform a thorough review of the clinical trial agreement, budget and sponsor informed consent documents to ensure synchronization and reduce the need for amendments

 

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