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). Use a PCSA to offset R & D by aligning protocol procedures with routine care since such expenses are reimbursed by governmental (i.e., Medicare) or private third-party payors. 


Realized Savings

4.1 mill.png
1.8.png
1.7.png

Benefits

Webp.net-resizeimage (7).jpg

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

Webp.net-resizeimage (2).jpg

Enhance internal operational efficiencies resulting in cost savings

Webp.net-resizeimage (3).jpg

Support routine care determinations with Medicare guidelines

 
Webp.net-resizeimage (2).jpg
 

Harmonize key study documents to reduce the need for amendments

Webp.net-resizeimage (24).png
 

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

Ready to get started?