Are there any limits to the amount of patient care costs that can be proposed for coverage under the 2023 BPS PFA?

PCORI encourages applicants to maximize patient care cost coverage from all available outside sources before requesting PCORI coverage of unmet needs. Sources of coverage may include the host healthcare delivery system, third-party payer, product manufacturer, developer of the intervention, or other interested parties.

Applicants may not exceed the maximum project budget of $5 million in direct costs for Category 1 studies and $10 million in direct costs for Category 2 studies. Although PCORI has not established any absolute dollar or percentage limit to the amount of patient care costs that an applicant may request, applicants should submit a realistic overall budget, which, if necessary, includes a well-supported and justified requested amount for PCORI coverage of patient care costs.