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Will PCORI cover any intervention costs in the budget?

Historically, PCORI has not covered the costs for study interventions or the clinical providers who administer them, together termed patient care costs. PCORI defines patient care costs broadly to include the cost of interventions themselves (such as medical products, procedures, or care services), as well as any additional clinical personnel costs associated with administering the interventions. Patient care costs may include procedures, medical devices, diagnostic tools, pharmaceuticals (including drugs and biologics), and integrative health practices and/or protocols involving clinical providers or other personnel delivering care. Patient care costs may be associated with treatment, care management, and delivery of healthcare services to treat, manage, diagnose, or prevent illness or injury of individuals.

For the Partner PFA, applicants may participate in a PCORI pilot allowing them to request coverage of patient care costs for potential funding by PCORI. This pilot will inform whether allowing such requests can meaningfully expand the breadth and impact of PCORI-funded research. Pilot requests must be realistic, well-supported, and justified while satisfactorily addressing the criteria described below. PCORI review and evaluation will determine which, if any, components of requested patient care costs may be potentially fundable. PCORI funding support for patient care costs is not assured.

By offering the possibility of funding support for patient care costs, PCORI intends to minimize financial hardship and barriers for patients and/or institutions to participate in critically important comparative clinical effectiveness research (CER). Note that PCORI is not seeking to equalize insurance coverage or compensation to medical providers and institutions. 

Although PCORI will consider and review requests for coverage of patient care costs, researchers are encouraged to seek funding or co-funding from a third party. Cost sharing by a third party (to provide a product, service, or other coverage) can provide evidence of support for a study and can demonstrate an increased likelihood for future sustainability and uptake of results.

The criteria for justification to be captured in the full application are as follows:     

  • Does the study address a strategically important comparative effectiveness question? Would study results have a potentially significant impact on clinical decision making or policy formation due to a major therapeutic advance in a medical product, procedure, or care delivery innovation?  
  • Is there evidence that the absence of coverage of patient care costs will pose a significant barrier to adequate recruitment of participants or to the access or inclusion of key participant groups? Would a significant and impactful research project be otherwise impossible to conduct without coverage of patient care costs?   
  • Is there a high likelihood of sustained uptake of study results in the absence of future cost subsidies, as evidenced by key stakeholders who have committed in letters of support to provide future support of patient care costs through staffing, reimbursement of services, modified policies, or other actions? Have any stakeholders evidenced their good-faith support of future implementation of the intervention(s) through contributions of funding or resources (e.g., data, personnel or a portion of personnel time, infrastructure, other in-kind items) to offset and reduce patient care costs requested of PCORI?   
  • Like all funding requests, the extent and amount of PCORI funding will ultimately be resolved in the process of contract and budget negotiations after applications are chosen for the award. Applicants should be prepared to address contingencies for conducting the proposed research project if PCORI declines to pay for some or all the requested patient care costs. 
  • Investigators seeking coverage of patient care costs should note such requests when submitting Letters of Intent (LOI) to this PFA as indicated in the LOI template. Invited applications should describe the patient care costs, their estimated amount(s), and the evidence and justification for their funding by addressing the above criteria within the appropriate sections of the application, described further in the Submission Instructions.
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