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Patient-Centered Outcomes Research Institute PCORI Form

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PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE (PCORI) FUNDING AGREEMENT AND COMPLIANCE FORM

RECITALS (WHEREAS)

WHEREAS, Research Organization Name: is an entity engaged in clinical comparative effectiveness research and desires funding and oversight in accordance with Patient-Centered Outcomes Research Institute funding and reporting requirements; and

WHEREAS, Patient-Centered Outcomes Research Institute Representative: (hereinafter "PCORI") has agreed to provide funding subject to the terms of this Agreement, and the parties intend to document their mutual obligations including scope, payment, reporting, and PCORI fee responsibilities;

WHEREAS, Award Number: and Effective Date: are set forth to govern the period in which the Research Organization will perform the funded research described below.

SCOPE OF WORK

The Research Organization shall perform the study, analyses, and deliverables described below. All work shall be performed in accordance with applicable federal, state, and PCORI requirements and consistent with accepted standards of scientific integrity.

PAYMENT TERMS

PCORI shall pay the Research Organization for performance of the Scope of Work as follows. Payment is conditioned upon satisfactory performance and submission of required reports and deliverables.

TERM AND TERMINATION

This Agreement shall commence on Start Date: and shall continue until End Date: unless earlier terminated as provided below.

Termination for Cause: Either party may terminate this Agreement for material breach by the other party if the breaching party fails to cure the breach within Cure Period (days): after written notice. Upon termination, obligations that by their nature survive termination shall remain in effect.

CONFIDENTIALITY

The parties acknowledge that sensitive information will be exchanged and agree to maintain the confidentiality of Confidential Information. Confidential Information means nonpublic technical, financial, patient-level, or business information disclosed by one party to the other that is marked confidential or reasonably should be understood to be confidential.

Confidentiality Obligations Acknowledgement: I acknowledge and will comply with the confidentiality obligations described above.

PCORI FEE, REPORTING, AND COMPLIANCE

The Research Organization agrees to comply with all PCORI-specific reporting, recordkeeping, and fee obligations applicable to the funded activities. The Research Organization shall prepare, submit, and retain documentation necessary to demonstrate compliance and to support any required assessment or fee calculations.

Research Organization will be solely responsible for PCORI fee calculation and remittance.
PCORI will withhold and remit applicable fees on behalf of the Research Organization as specified in funding terms.

Certification: By signing below, the signatories certify that they have the authority to bind their respective organizations, that the information provided is true and accurate to the best of their knowledge, and that they will comply with PCORI requirements, reporting obligations, and applicable law.

GOVERNING LAW; ENTIRE AGREEMENT

Governing Law: This Agreement will be governed by and construed in accordance with the laws of the State of , without regard to conflict of laws principles.

Entire Agreement: This Agreement, including its recitals and attachments incorporated by reference, constitutes the entire agreement between the parties with respect to its subject matter and supersedes all prior and contemporaneous agreements and understandings, whether written or oral. No amendment is effective unless in writing and signed by both parties.

ADDITIONAL PROVISIONS

Records and Audit Rights: The Research Organization shall retain books, records, and other documents relating to performance of the Scope of Work and shall permit reasonable inspection and audit by PCORI or its designee to verify compliance with this Agreement.

Research Organization:

By:

Date:

Patient-Centered Outcomes Research Institute Representative:

By:

Date:

Enter text✕

What the Patient-Centered Outcomes Research Institute PCORI Form Is

The Patient-Centered Outcomes Research Institute PCORI Form documents the assessment and reporting related to the PCORI fee under federal health care reporting rules. It is used by plan sponsors, insurers, and administrators to report covered lives and calculate any required fee payments on the applicable federal return. The form collects plan identifiers, plan year dates, covered life counts, and payer details so that the reporting party can determine and remit the appropriate amount to the federal government.

Why Accurate PCORI Form Reporting Matters

Accurate completion ensures compliance with federal reporting obligations, prevents assessment of interest and penalties, and preserves audit evidence. Proper reporting also supports plan governance and financial forecasting for benefits costs.

Why Accurate PCORI Form Reporting Matters

Who Typically Prepares and Signs This Form

Assign responsibility early—clarify whether the plan sponsor, insurer, or administrator will file and retain supporting records.

  • Plan sponsors and employers who offer self-insured group health plans and are responsible for fee calculation and remittance.
  • Insurers and health plan issuers that administer fully insured plans and report covered lives on behalf of policyholders.
  • Third-party administrators and benefits consultants who compile enrollment data and verify counts for filing accuracy.

Essential Elements Included on a Professional PCORI Form

A complete PCORI Form captures plan identity, plan year dates, covered life counts, payer information, calculation backup, and signature authority to support accurate reporting.

Plan Identifier

Employer or plan EIN and plan name as reported to the IRS to associate the filing with the correct tax entity and plan.

Plan Year Dates

Start and end dates of the plan year in MM/DD/YYYY format so covered life counts and fee calculations align with the correct period.

Covered Lives

Total covered life count with methodology (snapshot, average, or monthly) and supporting table showing how counts were derived for auditability.

Fee Calculation

Per-covered-life rate and arithmetic showing the multiplier, total amount due, and any rounding rules used in the final fee.

Payer Details

Name and address of the party remitting the fee, contact information, and the filing agent if a third party submitted the return.

Signature Block

Authorized signer name, title, printed name, signature and date confirming the filer attests to the accuracy of the reported information.

Step-by-Step: Completing the PCORI Form

Follow this sequential checklist to gather data and complete the form accurately before submission.

  • 01
    Gather enrollment: Collect covered life records and calculation method.
  • 02
    Verify plan dates: Confirm the exact plan year start and end.
  • 03
    Compute fee: Apply per-life rate and total the amount.
  • 04
    Sign and file: Authorize signature and submit with required return.

Setting Up an Online Workflow for PCORI Filing

Configure a repeatable digital workflow to capture counts, approvals, and audit trail evidence for each filing cycle.

Field Configuration
Document upload Accept PDF and DOCX supporting worksheets.
Signing order Define signer sequence for preparation and approval.
Payment reporting Capture remitter details and payment confirmation.
Audit trail retention Store IP, timestamp, and signer metadata.

Where to File or Send Your Completed PCORI Form

Understand the typical destinations for the completed form and any required accompanying federal return.

  • Federal return: Report fee on the applicable federal excise return.
  • Remitter account: Record payment details and remitter identification.
  • Plan records: Attach the computation worksheet for internal files.
  • Third-party filer: Confirm filing agent transmitted the return successfully.

Technical Considerations for Digital Completion and Storage

Confirm the platform meets legal and retention requirements for tax and healthcare-related documentation before relying on it as your single source of truth.

  • File formats: PDF and DOCX supported.
  • Integrations: Works with common accounting and HR systems.
  • Security: TLS and AES encryption required.

Typical eSignature Pricing and Feature Comparison

Compare baseline vendor pricing and core capabilities relevant to completing and signing PCORI-related documents. signNow appears first per vendor convention.

signNow DocuSign Adobe Sign PandaDoc HelloSign
Starting Price $8/user/mo $15/user/mo $14/user/mo $19/user/mo $15/user/mo
Free Trial 7-day free trial Varies Varies Varies Varies
Bulk Send Yes Yes Yes Yes Varies
Audit Trail Yes Yes Yes Yes Yes
HIPAA Compliant Yes Yes Yes No No
Envelope Cap No cap 100 envelopes/user/year Varies Varies Varies

Common Preparation Errors to Avoid

  • Miscounting covered lives by using inconsistent methods across months or failing to document the method and calculations.
  • Using incorrect plan year dates or mixing fiscal and calendar year reporting that shifts which covered lives are reportable.
  • Failing to attach or retain the detailed computation worksheet showing how per-life counts and totals were derived.
  • Relying on unsigned or unauthorized approvals that leave the filing without verifiable signer attribution and authority.

Risks and Consequences of Incorrect or Late Filings

Late Payment Exposure: Interest and penalties may be assessed
Audit Risk: Increased chance of IRS or plan audit
Data Discrepancies: Mismatch with tax records triggers inquiries
Remittance Errors: Underpayment may require corrective filings
Recordkeeping Gaps: Insufficient backup increases liability
Authority Questions: Unsigned filings may be rejected

Practical Steps to Reduce Risk and Save Time

Adopt consistent routines and digital controls to reduce errors and speed recurring PCORI reporting.

Reconcile enrollment before filing
Perform a reconciliation of covered lives against payroll and enrollment systems before finalizing counts. Document adjustments, the reconciliation method, and retain screenshots or export files used for verification and audit trails.
Centralize computation worksheets
Keep a single, version-controlled worksheet that shows the per-life rate calculation, rounding rules, and monthly values when averaging. Store this alongside the filed return for easy retrieval during reviews or audits.
Use authenticated signatures
Require an authorized official to sign with traceable attribution and an audit trail. Digital signatures compliant with ESIGN and UETA help demonstrate intent, attribution, and retention for electronic records.
Plan recurring workflows
Schedule quarterly or annual reminders, assign roles for data collection and sign-off, and use templates to standardize fields and reduce manual entry across filing cycles.

Frequently Asked Questions About the PCORI Form

Answers to common questions help clarify who files, what to include, how long to keep records, and acceptable signature methods.


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