Click on the links below to read questions and answers on post-awards.
Is PCORI a federal agency? What is PCORI’s Catalog of Federal Domestic Assistance (CFDA)?
No, PCORI is not a federal agency. PCORI is an independent, non-profit, nongovernmental organization authorized by the Patient Protection and Affordable Care Act (PPACA) of 2010. Since PCORI is not a federal agency, it does not have a CFDA.
Are funds in PCORI contract awards considered federal funds?
No. PCORI receives its funding, and in turn, issues contract awards, from a trust fund managed by the U.S. Treasury.
How does a PCORI contract award differ from other types?
PCORI funds research projects through contracts, rather than grants. The contracts are milestone and deliverables driven.
What are PCORI’s sources of funding?
The only source of PCORI funding is the PCOR Trust Fund (PCORTF). There are three contributory sources to the PCORTF, none of which is considered agency-specific appropriation dollars:
- Treasury’s general fund - contains some federal appropriations that are not tied to a specific agency.
- The Center for Medicare and Medicaid Services (CMS) - transfers funds into the PCORTF from their Federal Hospital Insurance (FHI) Trust Fund and Federal Supplementary Medical Insurance (FSMI) Trust Fund.
- The PCOR Fee – a portion of the PCOR fee assessed on private health insurance plans and self-insured plans, also supplements the PCORTF.
Is PCORI subject to the Uniform Guidance Single Audit, Subpart F?
No. PCORI, and its awards, are not subject to the Uniform Guidance. However, PCORI does contract an outside firm to conduct annual, independent financial audits of its records. PCORI also receives programmatic and financial oversight through GAO.
Is an awardee receiving PCORI funding subject to federal audit requirements in relation to that particular PCORI award?
No. However, PCORI, with reasonable advance written notice, does reserve the right to conduct site visits of PCORI funded projects. Moreover, PCORI may elect to send its authorized representative, which may at times be an outside third party vendor, to conduct financial audits.
The awardee, at its own discretion, may choose to include a PCORI award in the Uniform Guidance Single Audit or other audit testing. Nevertheless, PCORI awards are not required to be included the Single Audit testing.
What terms and conditions must an awardee receiving PCORI funding follow?
Awardees must follow the terms and conditions in the contract award. Awardees are expected to observe their institution’s applicable rules, regulations, and requirements for their institution’s type and previously established administrative policies and procedures (e.g., each organization will follow their applicable OMB Circulars and FAR). However, and to the extent permissible by law, PCORI terms and conditions are not subject to change.
What are my responsibilities as Principal Investigator (PI) of a contract award?
A PI is expected to be his/her institution’s primary contact person throughout the lifecycle of the contract award. To ensure staying on target and within budget, a PI must:
- Serve as the project lead in charge of research integrity
- Manage the research project while ensuring compliant and efficient progress
- Review and approve all activities and work completed by assigned project staff, consultants and subcontractors on the project
- Submit expenses according to contracted milestones and the approved budget
- Submit all required reports related to project performance, in a timely manner
Whom do I contact with questions about my award?
Contact the following:
- email@example.com – for questions regarding Broad, Targeted, and PCS research awards
- firstname.lastname@example.org – for questions regarding Engagement awards
- fundedDI@pcori.org – for questions regarding Dissemination and Implementation awards
How soon can I begin charging expenses to my award contract?
The funded recipient institution may incur PCORI project-specific expenditures up to three (3) months prior to the effective date listed in their fully executed contract document. Any expenses incurred prior to the date of approval and announcement by PCORI’s Board of Governors of the award, will not be authorized nor reimbursed.
It is expected that the funded recipient institution will have sufficient operational funds to allow initial financing of PCORI project activities. Engagement awards and Dissemination and Implementation awards are not eligible to expend costs prior to the effective date. Expenditures prior to effective date are allowable at the risk of the awardee institution.
If a contract is not executed due to the funded recipient institution’s failure to comply with contract requirements, PCORI will not be held responsible for any incurred expenses. Additionally, PCORI reserves the right to deny any expenses incurred prior to the execution of the contract - if the expense is not consistent with the approved budget.
Is the PCORI contract language negotiable?
PCORI’s various contract mechanisms, which are tailored to the type of research conducted, have firm terms and conditions that are not subject to change or negotiation with the exception of:
- An article not permissible by state law.
- An article that has a material adverse impact on the ability to enter into the contract.
A subcontractor on a PCORI project is requesting edits to the contract between the prime institution and the subcontractor. Is the contract language negotiable?
PCORI’s only relationship is that with the prime recipient institution. PCORI has no privity of contract with any of the prime recipient institution’s subcontractors. PCORI does not dictate what type of relationship or contract vehicle a prime recipient institution enters into with their subcontractor(s).
PCORI does expect the prime recipient institution to ensure the terms and conditions of its prime contract with PCORI flow through and are enforced, with no conflict, in all contractual relationships (written and verbal) related to the performance of PCORI’s projects.
Could a PI list administrative staff as a direct cost?
Since Facilities and Administrative (F&A) rates include remuneration for administrative and support staffs, these charges are not typically allowable. However, if needed for a given PCORI project, then yes, applicants are encouraged to propose and justify such costs for consideration on a case-by-case basis.
If the intended staff performs duties in direct relation to PCORI’s awarded project and their effort can be clearly and exclusively attributed to the PCORI project supported by way of time or effort reporting, then the recipient institution may charge that portion of their time and effort as a direct cost. Please refer to the PCORI Cost Principles for more information.
What indirect cost rate should awardees use in their budget?
U.S. institutions may apply an approved indirect rate of up to 40%, while international institutions may only apply an indirect rate of 10% to the project’s direct cost base.
If an applicant organization’s federally-negotiated, or independently audited, indirect rate is less than 40% (domestic) or 10% (international), then the applicant must apply the lower negotiated rate to the allowable direct cost base.
If an applicant organization has multiple rates, then it should choose the rate that complies with the conditions of the approved IDC rate agreement. Typically, this is the rate that applies to where the PI conducts the research.
What if an awardee does not have a federally negotiated or privately audited indirect cost rate?
If an institution has a negotiated NICRA, then PCORI will accept the NICRA until its time of expiration.
If an institution has no rate agreement or independent rate verification by a CPA, then PCORI will allow a 10% default rate.
In no event shall PCORI be invoiced for any expenses related to establishing such rate, be it through an independent audit, or activities in preparation for a federally-established rate.
What if I want to spend funds differently than indicated in my proposal or award budget?
PCORI allows re-budgeting within any budget category based on the total amount approved for that category over the project period of performance. The re-budgeting should not result in a change in the amount of the overall approved contract budget.
PCORI’s written approval is required for any re-budgeting exceeding 25% for Personnel and Travel budget categories. The recipient institution shall submit a request on letterhead to email@example.com that is signed by the authorized Administrative Official and inclusive of a detailed budget and budget justification for each program year.
Can I request supplemental funds after my contract is awarded?
PCORI does not accept unsolicited proposals for supplemental funding. In the event a PCORI Program Officer identifies an existing project that could generate beneficial data or results that were not included in the original budget, then additional funding to modify the project scope may be added through a formal contract modification. In such an event, the Post-Award Contracts Administrator will request a proposal and budget for the additional work.
Do I need to request carryover between budget years?
No. Most of PCORI projects are funded for multiple years, and the approved budgets cover the full project period of performance. PCORI does, however, reserve the right to stop and/or withdraw any project funding due to inadequate or delayed performance, as well as failure to expend funds in accordance with approved budget categories and milestone schedule.
Can patient participants be charged a co-pay to participate in a study intervention? Can this or other sources of revenue, be used towards supporting the PCORI project?
Recipient institution must obtain approval from their Institutional Review Board (IRB) and/or Data and Safety Monitoring Board (DSMB) to include co-pays or other activities that will generate revenue as a result of carrying out the PCORI project. Once IRB and/or DSMB approval is received, the activities, expected funds/revenue generated, must be clearly outlined in the Proposal, Budget, and Budget Justification, and PCORI’s approval sought.
Any generated revenues must be disclosed and offset against current project expenses thereby reducing the overall budget amount that can be collected from PCORI. Otherwise, the overall award amount would, in effect, increase and appear as program income or revenue-generating activities.
IMPORTANT: PCORI is prohibited by authorizing legislation from generating revenue or program income as a result of its funded research, and cannot accept revenue from any source other than the PCORTF.
How do qualifying expenses on an award get paid?
Unless specified otherwise in the research award contract, recipient institutions must submit invoices no less than every 90 days detailing charges to each approved budget category. Invoices must be supported by a labor detail report reflecting the salary for all personnel charged to the project.
For fixed-price awards, submit invoices based on the milestone and payment schedule found in the contract, typically when a report is due.
Once an invoice is deemed acceptable and is approved (and deliverables have been met), payment is issued within 30 days of receipt. A payment may be withheld if the recipient institution either fails to provide the detail and documents the contract requests, or fails to justify an expense questioned by the Patient-Centered Outcomes Research Institute (PCORI).
Invoices must be submitted through PCORI Online, which can be accessed through https://pcori.force.com/engagement.
How should awardees bill personnel effort on invoices to PCORI?
Only the actual level of effort should be billed to PCORI. If a particular position is budgeted at 10 percent effort and the researcher spends 15 percent effort on the project in the first month and 5 percent in the second month, then the recipient institution would report it exactly as 15 percent and 5 percent.
Does PCORI require effort certification reporting?
Awardees must follow their institutional policies regarding effort certification. Although effort certification is not required at the time of invoice submission, PCORI may request certification documentation during a financial compliance review.
Are subcontractors required to submit labor detail reports with invoices to the primary Awardee Institution?
A prime recipient is responsible for justifying and supporting all billed items, amounts, and categories to PCORI, which may or may not involve labor reports from subcontractors. The prime must ensure that the flow-downs of PCORI’s contract have been properly communicated in the performance of all work related to the project. Although subcontractor labor detail is not required at the time of invoice submission, PCORI may request certification documentation during a financial compliance review.
If an institution is subject to the Single Audit, or its financial statements are audited annually and it has effort certification controls in place, is the institution still required to submit labor detail with each invoice?
Yes, all awardees requesting salary and fringe benefits are required to submit labor detail with invoices.
In place of a Financial Official, is an (Authorized) Administrative Official’s signature acceptable on invoices submitted to PCORI?
Yes, an (Authorized) Administrative Official’s signature or explicit indication of approval is adequate.
What if an institution considers salary information as confidential information that cannot be shared with outside organizations?
The labor detail should then be submitted to show title and rate (rather than name). The invoice will be verified against the approved budget detail in the executed contract.
If an institution’s system-generated invoice does not include all of the cost categories PCORI requires, is a system-generated invoice still required to be submitted?
Yes. All invoices submitted to PCORI must contain all cost categories outlined within the contract. If a standard system-generated invoice does not capture the needed information, then an institution must populate the Sample Invoice Template provided by PCORI on the Awardee Resources page. The institution must also provide its system-generated invoice for cross-validation.
My institution received a provisional indirect cost rate, or has a new indirect cost rate, that is different from what was proposed at the time of award. What do I need to do?
Contact your assigned Contracts Administrator because the revised rate might require a budget modification to the contract.
My institution does not have an audited indirect cost rate. Can we ask for indirect costs?
Institutions without a federally negotiated or audited rate can request a de minimus rate of 10 percent of the allowable direct costs. See the Application Guidelines and PCORI Cost Principles for a description of allowable direct costs under a PCORI award.
Does PCORI provide advance payments?
No. PCORI reimburses awardees for actual incurred costs or for milestones achieved. However, awardees can submit invoices more frequently than every 90 days (e.g., every week, biweekly, monthly, etc.) as their cash position requires. See your contract for payment terms and the milestone schedule.
Can I continue billing for research expenses after the research period of performance milestone outlined in the contract if we have remaining funds or research work?
No. Only costs associated with research incurred prior to the research period of performance end date can be billed to PCORI.
When are reports due?
Due dates are specified in the milestone schedule of the fully-executed contract, as well as the reporting section. As stipulated in the contract, PCORI reserves the right to change the frequency in which it asks for reports from the prime recipient.
Reports require authorization and signatures from both the Principal Investigator (PI) and an authorized signing official. All reports should be submitted to PCORI using the PCORI Online system accessed through: https://pcori.force.com/engagement
How do I submit monthly enrollment updates for my research award?
PCORI awardees are requested to submit monthly enrollment updates directly to their Program Officer (PO) and Program Associate (PA) via email. Cumulative enrollment updates on Race, Ethnicity, and Gender may be added to progress reports in PCORI Online. Awardees should discuss reporting needs and format with their PO/PA.
What should I do if I want to make changes to my project?
Ongoing discussions regarding rate of progress, obstacles, challenges etc., should be held with your PCORI Program Officer throughout the period of the project. If the changes are mutually agreeable and enhance the overall research initiative, then your PCORI Program Officer will contact the Contracts Management and Administration office to consult on the needed documentation, budgets, scope changes, and justification.
Proposed changes to the project may require prior PCORI approval. Please see the administrative requirements section of your contract for complete details for required prior approvals. All documentation should be submitted to the PCORI Contracts Management and Administration department as soon as possible to process the request. All requests must be submitted on formal letter head and submitted by the institutions Administrative Official (AO). Funded recipients should not implement any proposed project changes until receiving PCORI approval.
Can a contract award be transferred from one institution to another?
PCORI contracts are with the recipient institution and not the individual PI. The transfer must first be approved by PCORI. If a PI would like to transfer a contract (after award notification), then he/she must provide notice and receive written approval from the Administrative Official of the original recipient institution.
The original contract will be closed out, and a new contract will be negotiated and awarded to the transfer recipient institution.
Posted: June 2014; Updated: June 6, 2017