Document type: Checklist Practice area: Litigation — Government Enforcement Jurisdiction: United States (federal) Last reviewed: 5 September 2026

Part 1 — Recognizing that a case exists

Qui tam complaints are filed in camera and under seal under 31 U.S.C. § 3730(b)(2) and are not served until a court orders it. Assume you learn late.

  • Civil investigative demand under 31 U.S.C. § 3733 received — almost always means a sealed qui tam exists.
  • Grand jury subpoena (signals criminal exposure).
  • Unusual or unannounced agency audit.
  • Inspector general or agent interview of a current employee.
  • Former employee's counsel requesting a personnel file.
  • Departing employee who downloaded documents.
  • Unexplained request for historical billing or certification records.

Read the CID's scope for the theory:

  • Claims data only → coding or clerical theory.
  • Communications about policy → the theory is knowledge.
  • Date range → the limitations theory (§ 3731(b): six years, or three from official knowledge, capped at ten).
  • A specific policy or memorandum requested by name → the relator already has it.

Part 2 — The first thirty days

  • Experienced FCA counsel engaged immediately.
  • Litigation hold issued, reaching: email, chat and messaging platforms, shared drives, the billing system, the operational or clinical documentation system, voicemail, and personal devices used for work.
  • Custodians identified by role, not seniority.
  • Auto-deletion suspended and CONFIRMED IN WRITING by IT for each system — including retention rules nobody remembers configuring.
  • CID scope negotiated in writing: custodians, date range, search terms, production format, schedule.
  • Privileged internal investigation opened on a parallel track, scoped in writing, staffed by counsel rather than the business.
  • Upjohn warnings given and documented in every interview.
  • No retaliation — legal review required for any personnel action touching anyone who has raised a compliance concern.
  • No public statements.
  • Insurance carriers notified promptly under D&O, professional liability, and any regulatory investigation coverage. Late notice is an avoidable forfeiture.

Part 3 — The internal investigation

  • Claim generation process mapped end to end: trigger, data, review, certification, signer.
  • The interpretation file located — did anyone identify the ambiguity at the time? Memoranda, outside counsel opinions, policy committee minutes, training materials.
  • Understood: after United States ex rel. Schutte v. SuperValu Inc., 598 U.S. 739 (2023), scienter is subjective. A contemporaneous record of question → analysis → advice → decision → consistent application is the strongest defense; its absence is a serious problem.
  • Internal complaint record located: was this raised? What happened? (A complaint investigated and resolved is a defense; ignored, it produces the relator.)
  • Adverse documents confronted, not avoided.
  • Exposure quantified: claim count × penalty, plus 3× the damages measure under § 3729(a)(1).

Privilege discipline:

  • Consultants and forensic accountants retained through counsel, purpose documented.
  • Memoranda format chosen knowingly (attorney impressions vs. verbatim transcripts).
  • Point identified at which an individual needs separate counsel; funding offered.
  • No "findings" document drafted until its conclusions are settled.
  • Waiver question planned in advance at board level — never decided incrementally by a deposition witness.
  • Investigation closed properly: documented conclusion, remediation, disclosure decision, dated and approved.

Part 4 — The materiality record

Under Universal Health Services, Inc. v. United States ex rel. Escobar, 579 U.S. 176 (2016), materiality is demanding. Payment in full with actual knowledge of noncompliance is strong evidence the requirement is not material.

  • Audit and review history obtained — was the practice visible in sampled records? Any adjustment? Did payment continue?
  • Read your own audit reports. (The best defense document is frequently one nobody opened.)
  • Agency guidance and its evolution collected.
  • Prior enforcement practice on this requirement researched.
  • Payment history and any denials for the claims at issue.
  • Communications with the agency or its contractor about the practice.
  • Industry practice, where the agency was on notice.
  • FOIA requests and contractor record requests made EARLY — they take months.
  • Noted: materiality is not established merely because the government could have declined payment, or because the requirement was labeled a condition of payment.

Part 5 — The jurisdictional bars (research during the seal)

First-to-file — § 3730(b)(5):

  • Search for earlier-filed related actions against the company.
  • Assess whether they allege the same essential facts.

Public disclosure — § 3730(e)(4):

Limitations — § 3731(b):

Part 6 — The presentation to the government

The government, not the relator, is the audience.

  • Understood: intervention under § 3730(b)(4) shapes everything; and under United States ex rel. Polansky v. Executive Health Resources, Inc., 599 U.S. 419 (2023) a government persuaded the case lacks merit may intervene and dismiss, with courts granting such motions in all but the most exceptional cases.
  • Presentation built on documents, not narrative: the interpretation file, the audit and payment history, the claim-process map.
  • Weak facts addressed honestly — a presentation that ignores the bad email is discounted entirely.
  • Short, in person, organized around the elements, with a written submission that can circulate internally afterward.
  • Agency counsel included where the defense rests on agency guidance, audit practice, or continued payment.
  • Risks weighed: educating the government, revealing defenses, prompting new questions, and — where criminal exposure exists — availability to the criminal component.
  • Every agency contact coordinated with DOJ counsel, purpose in writing.

Part 7 — When the complaint is served

  • Complaint read against what is already known; note where the relator's theory differs.
  • Motion to dismiss filed, strongest ground first:
    • Rule 9(b) particularity — know whether your circuit requires representative claims or accepts a scheme plus reliable indicia. Frequently the most efficient ground.
    • Materiality under Escobar.
    • Falsity — regulatory noncompliance is not automatically a false claim; disagreements about clinical judgment, contract interpretation, or reasonable estimates are not fraud.
    • Scienter — no facts pleaded about what the defendant actually believed.
    • The bars, from Part 5.
  • Venue examined — § 3732 is notably broad, and circuit differences on Rule 9(b) matter.
  • Counterclaims assessed with caution — a counterclaim that would penalize the relator for bringing the action is generally impermissible and hands the relator a retaliation narrative.

Part 8 — Discovery

Sought from the relator:

  • What was known, and when.
  • What documents were taken, and how.
  • Communications with counsel about compensation.
  • Prior employment issues.
  • The § 3730(b)(2) disclosure statement served on the Government — frequently the most useful document in the case.

Sought from the government (even in a declined case):

  • Agency knowledge and payment practice — the materiality evidence. Contested and worth fighting for.

Managed:

  • Parallel § 3730(h) retaliation discovery, which proceeds publicly.
  • Any criminal investigation; stay of the civil case considered.
  • Privilege maintained; waiver decisions escalated.

Part 9 — Settlement

Negotiate in this order:

  • The damages base first — benefit-of-the-bargain crediting value delivered, versus gross damages. Every dollar removed is removed three times.
  • Then the multiplier — a multiple of single damages reflecting conduct, cooperation, ability to pay, and litigation risk.
  • Then the relator's share and fees, separately — § 3730(d) fixes the share, and a prevailing relator recovers expenses, fees, and costs from the defendant. In a small declined case the fee component can exceed the damages component.
  • Collateral terms, often more consequential than the money:
    • Suspension and debarment; administrative agreement for contractors.
    • Program exclusion and a corporate integrity agreement for healthcare defendants — multi-year, independent review organization, reporting, executive certifications.
    • Negotiated with different government components than the payment.
  • Scope of release: conduct, period, entities, claims — and what is reserved (criminal, tax, administrative claims typically are).
  • Recitals negotiated — the press release is what the market reads.
  • Individual exposure addressed expressly, or expressly not, with conflicts understood.
  • Timing lever known: § 3729(a)(2) reduces the multiplier to not less than double damages for disclosure of all known information within 30 days, full cooperation, and no prior investigation.

Part 10 — Parallel criminal exposure

  • Signals watched: grand jury subpoena; unannounced agent interviews, especially at homes; requests not to disclose; a criminal AUSA involved.
  • Individual counsel provided where exposure diverges.
  • Upjohn warnings documented in every interview.
  • Cooperation decision made at board level, understanding it generally requires providing information about individuals.
  • Statements to agents recognized as carrying separate criminal exposure.
  • Civil discovery, testimony, and settlement statements understood to be usable in the criminal matter.
  • Counsel coordinated; stay of the civil case considered.
  • Client advised: resolving one does not resolve the other; civil settlements reserve criminal claims.

Part 11 — The retaliation claim

  • Section 3730(h) understood: protects lawful acts in furtherance of an FCA action or other efforts to stop a violation; relief includes reinstatement, 2× back pay, interest, and special damages including fees.
  • Recognized as easier to prove than the qui tam — no false claim need be established.
  • Recognized as public while the qui tam is sealed, generating discovery used in the sealed case.
  • Adverse action suspended against anyone who raised a compliance concern; legal review required.
  • Pre-complaint history reconstructed immediately — reviews, discipline, compensation, reorganization plans predating the protected activity.
  • Timing examined honestly.
  • Early resolution considered.
  • Release drafted knowing that barring participation in the qui tam or communication with the government is unenforceable and becomes evidence of obstruction.

Part 12 — The relator's checklist

  • Is there an actual claim for federal payment, not merely regulatory noncompliance?
  • Is there evidence of knowledge under § 3729(b)(1) — subjective, after Schutte?
  • Is the violation material under Escobar — and has the agency kept paying with knowledge?
  • First-to-file and public disclosure bars researched before drafting.
  • Original-source position assessed.
  • Client advised honestly: years under seal, high probability of declination, funding decision if declined, discovery into the client's own conduct, likely loss of the job.
  • No document removal counseled — exposure under confidentiality obligations, computer access statutes, and trade secret law, plus a motive narrative for the defense.
  • Disclosure statement written seriously — § 3730(b)(2) requires substantially all material evidence; it drives the intervention decision more than the complaint does; honest about weaknesses.
  • Pleaded to Rule 9(b) in the applicable circuit's formulation; venue proper under § 3732.
  • Prepared for repeated seal extensions.

Part 13 — Compliance, before any of this

  • Every process ending in a request for federal money mapped — billing, invoicing, reimbursement, grant drawdowns, certifications. Including as a subcontractor or supplier: § 3729(b)(2) reaches claims to a contractor or grantee where the money is spent on the Government's behalf.
  • Certification inventory: which ones we make, who signs, what diligence supports the signature, and whether that diligence is real.
  • Ambiguity resolutions documented contemporaneously — question, analysis, advice obtained, decision, date — and applied consistently. The single highest-value practice after Schutte.
  • Internal reports investigated and the response documented.
  • Audit reports actually read, and findings acted on.
  • Departures handled with exit interviews, documented responses, and nothing resembling retaliation.
  • Periodic self-audits of areas where a false claim could arise.
  • Disclosure decision pre-considered: who decides, on what standard, given the 30-day window in § 3729(a)(2) and any mandatory disclosure obligation.
  • Retention schedules reviewed so that the documents that would exonerate the company still exist.

Related documents

This checklist is general information, not legal advice, and does not create an attorney-client relationship.