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, and payment is strictly tied to expenses related to successful performance and achievement of contract milestones and deliverables.
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 A-133 audit?
No. PCORI is not subject to OMB Circular A-133. 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 A-133 or other audit testing. Nevertheless, PCORI awards are not required to be included in A-133 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?
For Pilot Project recipients, please contact firstname.lastname@example.org and for all other funded recipients please contact email@example.com with questions regarding PCORI funded activities. To facilitate PCORI’s timely response, in the subject line the name of the Principal Investigator please include, name of funding cycle, and contract number (if applicable).
How soon can I begin charging expenses to my contract award?
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.
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.
If there is a delay with the contract execution, will the period of performance be extended in equal measure?
Yes. PCORI strives to adhere to the period of performance posted on PCORI website. If a delay in execution becomes inevitable during contract negotiations, PCORI will work with recipient institutions to adjust the period of performance and related milestones, if possible given the constraints.
Once a contract is executed, a period of performance may only be changed when a justifiable and written proposal is submitted to PCORI’s Program Officer, and approved in writing by PCORI’s Director of Contracts Management and Administration office, by way of written contract modification.
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.
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 up to 25% 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.
To illustrate: If the total budget for the Supplies category is $10,000 over 3 years, then up to $2,500 can be added into supplies, or removed from supplies, without prior approval.
PCORI’s written approval is required for any re-budgeting exceeding the 25%. The recipient institution shall submit a request on letterhead to firstname.lastname@example.org 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.
What is cost sharing?
When a portion of project costs are not charged to PCORI’s contract. It includes all contributions, be it cash or in-kind, that a recipient institution makes to a PCORI contract. All proposed cost sharing should be clearly delineated in the recipient’s Budget and Budget Justification.
What is co-funding?
A funding arrangement through which PCORI, along with one or more organizations, shares in the total funding of a research project. In the event of co-funding, budgeted costs for the research project should be unique to each funding organization with no overlap in the usage of funds. All proposed co-funding must be formally submitted with the approval of the PI and Administrative Officer; and receive prior PCORI approval.
What is funding overlap?
It occurs when budgeted items are requested from PCORI in a proposal/application, but are already funded by another source. Applicant institutions are required to disclose other project sponsors. Further, awardees are required to verify labor distributions of key personnel and attest that the costs are not billed or covered elsewhere.
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 contract, recipient institutions are required to submit monthly invoices 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.
Once an invoice is deemed acceptable and approved (and deliverables have been met), payment is issued. A payment may be withheld if the recipient institution either fails to provide the detail/documents requested by the contract, or fails to justify an expense questioned by PCORI.
Invoices should be sent directly to email@example.com.
How should awardees bill personnel effort on monthly invoices to PCORI?
Only the actual level of effort should be billed to PCORI. If a particular position is budgeted at 10% effort and the researcher spends 15% effort on the project in the first month and 5% in the second month, then the recipient institution would report it exactly as 15% and 5%.
Does PCORI require effort certification reporting?
PCORI requires a system generated labor detail report to be submitted with all invoices requesting salary and/or fringe benefit remuneration. For some organizations, the detail may include an effort percentage on the PCORI project for that given billing period, and for others it may include hours attributed to the PCORI project. While PCORI does not require formal effort certification from an organization’s cognizant agency, the labor detail reported is subject to audit by PCORI, its auditors, and the GAO.
Are subcontracts required to submit labor detail reports with invoices to the primary awardee institution?
PCORI is not and will not be privy to the relationship between the prime recipient and its subcontractors. 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 the flow downs of PCORI’s contract have been properly communicated in the performance of all work related to the project.
If an institution is annually audited under A-133, and has effort certification controls in place, are they still required to submit a labor detail report with each invoice?
Yes, all awardees requesting salary and fringe are required to submit a labor detail report with all monthly 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.
An institution’s system-generated invoice does not include all of the cost categories required by PCORI. Is a system-generated invoice still required to be submitted?
All invoices submitted to PCORI must include the following categories: Salaries, Fringe Benefits, Consultant Costs, Supplies, Travel, Other Expenses, Equipment, Inpatient/Outpatient Costs, and Indirect Costs. If a standard system-generated invoice does not capture the needed information, then an institution must populate the sample invoice template provided by PCORI, as well as provide their system generated invoice for cross-validation.
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 firstname.lastname@example.org. Pilot Project reporting should be submitted to email@example.com.
My contract is ending soon – do I have to do anything?
Yes. PCORI requires the funded recipient to submit a final expenditure report and a final progress report within 90 days of the period of performance end date, as stated in the reporting requirement section of the fully executed contract.
What should I do if I want to make changes to my project or scope of work? Or can’t finish the project on time?
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 scope of work or period of performance require prior PCORI approval. All documentation should be submitted to the PCORI Contracts Management and Administration department at firstname.lastname@example.org as soon as possible to process the request. Pilot Project recipients should submit requests to email@example.com. Funded recipients should not implement any scope of work changes until receiving PCORI approval. Please see the administrative requirements section of your contract for complete details.
Active portfolio management is expected between awardees and their designated PCORI Program Officer. PCORI does not usually modify contracts to change the end date. PCORI expects its prime recipients to fulfill milestones and deliverables in order to prevent a potential breach of contract terms.
PCORI, at its sole discretion, may issue a contract modification to extend the project period if the recipient institution has been regularly communicating progress to their PCORI Program Officer and the extension will benefit the overall initiative.
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.
The overall value of the award cannot increase as a result of the transfer activity. Pilot Project recipients should contact firstname.lastname@example.org for further instructions. All other awardees should contact email@example.com for further instructions.
Posted: June 2014; Updated: September 4, 2014