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What are PCORI’s guidelines for treatment cost/coverage?

The delivery system, payer, manufacturer, or developer of the intervention must cover costs for study interventions. Given the reimbursement barriers often associated with nonpharmacological alternatives to opioids, the applications must specifically address, in the context of the proposed studies, the support from payers, health plans, industry sponsors or others in covering the study interventions.

The willingness of one or more of the stakeholder groups to cover treatment costs, even when one of the proposed intervention arms is not currently covered by insurance, will be taken as strong endorsement of the study by the healthcare system or payer and of the likelihood that the stakeholder groups will implement or use the study’s findings, if definitive. This material support for the study by host delivery system, payer, or developer should be discussed in the application.

If the interventions being tested include staff or interventions not already available at the site, such as pharmacists, dietitians, health coaches, or community health workers, would the contract cover these personnel costs?

PCORI generally requires that the costs of clinical care, including such personnel costs, be covered by usual coverage practices. PCORI will cover personnel costs for administering informed consent and collecting data and for other research-related costs. In special circumstances, the application’s Research Plan may explain how stakeholders, including payers, would consider covering the costs of these additional personnel should the interventions be found to be comparatively effective. In such cases, PCORI may consider covering these personnel costs in the study.

Are there costs that PCORI will not cover?

Yes. PCORI will not cover costs for available clinical care alternatives that are being proposed for comparison.

What types of costs will PCORI cover?

PCORI will consider covering costs for ancillary tasks necessary in the implementation or monitoring of a clinical intervention or strategy as part of the research program. Examples include costs for obtaining consent, collecting data, or monitoring that would not normally be performed in routine care. Support for the study by the involved healthcare delivery systems must be documented.

PCORI may allow for the coverage of co-payments or co-insurance or allow for other appropriate measures to the extent that such coverage or other measures are necessary to preserve the validity of a research project, such as in the case where the research project must be blinded. Please refer to PCORI’s policy regarding allowable and unallowable costs in Appendix 2 of the Application Guidelines.

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