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

How to use this toolkit

Two facts organize everything here.

You learn late. Complaints are filed under seal under 31 U.S.C. § 3730(b)(2) and are not served until a court orders it. By the time a civil investigative demand arrives under § 3733, the government has been investigating with the relator's help for a year or more.

The case is usually decided by documents created years earlier. The contemporaneous interpretation file that answers scienter after United States ex rel. Schutte v. SuperValu Inc., 598 U.S. 739 (2023), and the agency payment history that answers materiality after Universal Health Services, Inc. v. United States ex rel. Escobar, 579 U.S. 176 (2016). Tools 6, 7, and 13 are about those two records.

Tool 1 — Signal recognition and theory diagnosis

FCA SIGNAL ASSESSMENT — [Company] — [Date] — PRIVILEGED

WHAT ARRIVED
  [ ] Civil investigative demand (31 U.S.C. § 3733)
      ** Almost always means a sealed qui tam exists **
  [ ] Grand jury subpoena  ** → criminal component **
  [ ] Unusual or unannounced agency audit
  [ ] OIG / agent interview of a current employee
  [ ] Former employee's counsel requesting a personnel file
  [ ] Departing employee downloaded documents
  [ ] Unexplained request for historical billing/certification data

DIAGNOSE THE THEORY FROM THE SCOPE
  Date range: ____________
    → limitations theory: 6 yrs (§ 3731(b)(1)) or discovery rule?
    → assume up to 10 years (Cochise Consultancy)
  Document categories requested:
    [ ] Claims data only        → coding / clerical theory
    [ ] ** Communications about policy ** → theory is KNOWLEDGE
    [ ] Compliance files        → theory is knowledge
    [ ] Specific policy or memo requested BY NAME
        ** → the relator already has it: ______________ **
  Custodian list: ______________
    → whom has the relator identified?
  Programs / payors implicated: ______________
  Estimated claim count in the period: ______
  ** EXPOSURE: claims × penalty + 3 × damages = $__________ **

WHO IS THE LIKELY RELATOR?
  Departures in the last 3 years from the implicated function:
  ______________________
  Anyone who raised this internally: ______________

Annotation. The custodian list and the named-document line are the two most informative parts of a CID and are usually skimmed. A demand for a specific memorandum by title means the relator possesses it, which tells you both who the relator likely is and what the theory is. Diagnose before you produce.

Tool 2 — First thirty days protocol

DAY 1
 [ ] Experienced FCA counsel engaged
 [ ] Response team named: legal lead ____ / IT ____ /
     business SME ____ / communications ____
 [ ] ** No public statements. No personnel actions. **
 [ ] Insurance carriers notified (D&O, professional liability,
     regulatory investigations coverage)
     ** Late notice is an avoidable coverage forfeiture **

DAYS 1-5 — LITIGATION HOLD (see Tool 3)
 [ ] Issued  [ ] Acknowledged by custodians
 [ ] ** IT confirms IN WRITING that auto-deletion is suspended
     in EACH system **

DAYS 5-15
 [ ] CID scope negotiation opened in writing with the AUSA
 [ ] Internal investigation scoped and opened (Tool 4)
 [ ] Privilege protocol established
 [ ] Board or audit committee briefed; reserve/disclosure
     question referred to auditors and disclosure counsel

DAYS 15-30
 [ ] Claim process mapped (Tool 5)
 [ ] Scienter file search begun (Tool 6)
 [ ] Materiality record requests SENT (Tool 7) — they take months
 [ ] Jurisdictional bar research begun (Tool 8)
 [ ] Personnel action freeze communicated to HR and managers

Annotation. The boxed personnel freeze on Day 1 prevents the most avoidable disaster in these matters. Section 3730(h) retaliation exposure is easier to prove than the qui tam, is litigated in public while the qui tam stays sealed, and is frequently created after the company learns of the investigation by a manager who has not been told anything.

Tool 3 — Litigation hold (FCA scope)

LITIGATION HOLD NOTICE — [Matter]

You must preserve all documents and communications relating to
[subject], for the period [dates], including:

SYSTEMS — preservation confirmed by IT for each
 [ ] Email (including archives and deleted items)
 [ ] ** Chat / messaging platforms ** (Teams, Slack, SMS) —
     including any auto-delete rule
 [ ] Shared drives and document repositories
 [ ] Billing / claims system, including audit logs
 [ ] Clinical or operational documentation system
 [ ] Compliance system: complaints, investigations, hotline
 [ ] Training records and materials
 [ ] Voicemail
 [ ] ** Personal devices used for work **
 [ ] Departed-employee accounts and devices
 [ ] Backups and any legacy system holding the period

CUSTODIANS — identified by ROLE, not seniority
 Billing / coding · compliance · clinical or operational leads ·
 finance · anyone who signed a certification · anyone named in
 the CID · anyone who raised a concern

SUSPEND
 [ ] Routine deletion  [ ] Retention schedule destruction
 [ ] Device wipe on departure  [ ] Auto-purge rules

IT CONFIRMATION
 System | Deletion suspended? | Confirmed by | Date
 [Written confirmation for EACH — a hold issued but not
  implemented is worse than none.]

REMINDERS: quarterly, with re-acknowledgment

Annotation. The chat platform line and the IT confirmation table exist because that is where holds fail. Messaging platforms frequently have short default retention that nobody in legal knows about, and a hold that was announced but not technically implemented documents that the company knew and did nothing — which becomes evidence of the scienter Schutte made central.

Tool 4 — Internal investigation scope memorandum and Upjohn script

INVESTIGATION SCOPE — [Matter] — PRIVILEGED & CONFIDENTIAL
Prepared at the direction of counsel in anticipation of litigation

AUTHORIZED BY: ______________  DATE: ______
COUNSEL DIRECTING: ______________

SCOPE
  Conduct: ______________________
  Period: ______________________
  Systems: ______________________
  Custodians / interviewees: ______________________
  Out of scope (and why): ______________________

QUESTIONS TO ANSWER
  1. Was a claim for federal payment submitted?
  2. Was it false or misleading?
  3. ** What did the company actually believe, and when? **
  4. Was the requirement material — what did the agency know
     and do?
  5. Who raised concerns, and what happened?

STAFFING
  Counsel: ______  Consultants retained THROUGH COUNSEL: ______
  Purpose of consultant engagement documented: [ ]

FORMAT
  [ ] Attorney memoranda (mental impressions — core work product)
  [ ] Verbatim transcripts/recordings (far less protected)
  ** Choose knowingly. **

NO "FINDINGS" DOCUMENT until conclusions are settled.

UPJOHN WARNING — read and record in EVERY interview

"I am a lawyer for [Company]. I represent the Company, ** not you
personally. ** I am conducting this interview to gather facts so
the Company can obtain legal advice. This conversation is
privileged, but ** the privilege belongs to the Company, not to
you **, and the Company may decide to waive it and disclose what
you tell me, including to the government. Please keep this
conversation confidential. Do you understand? Do you have any
questions before we begin?"

Interviewer: ______  Interviewee: ______  Date: ______
Warning given and understood: [ ]  Second attorney present: [ ]

** IF THE INTERVIEWEE'S EXPOSURE DIVERGES FROM THE COMPANY'S —
   stop, say so, and offer to fund separate counsel. **

Annotation. The closing instruction is the one that gets skipped under time pressure. Continuing to interview an employee whose own exposure has become apparent, under a company banner, damages the individual and taints the investigation. Recognize the moment, stop, and refer.

Tool 5 — Claim process map

CLAIM PROCESS MAP — [Program / payor]

 Step | What happens | System | Who does it | What is asserted or
 certified | Supporting documentation | Control

 1. Service / good delivered
 2. Documentation created
 3. Coding / pricing applied
 4. Internal review
 5. ** CERTIFICATION ** — text: ______________
        Signed by: ______  On what diligence: ______
 6. Claim submitted
 7. Payment received
 8. Post-payment review / adjustment
 9. Overpayment identification and return
    ** (failure here = reverse false claim, § 3729(a)(1)(G)) **

REQUIREMENTS THAT COULD BE ALLEGED AS CONDITIONS
 Requirement | Source (statute/reg/contract/manual) | Is it
 ambiguous? | Do we have an interpretation file? (Tool 6) |
 Agency payment practice? (Tool 7)

Annotation. Step 9 is the one companies omit from their own process maps and the one that produces reverse false claim liability under § 3729(a)(1)(G) — knowingly concealing or improperly avoiding an obligation to pay money to the Government. Identified overpayments that are not returned convert an ordinary billing error into an FCA case.

Tool 6 — Scienter file index

THE SCIENTER FILE — what we actually believed, and when
[After Schutte, scienter is SUBJECTIVE. This file is the defense.]

THE REQUIREMENT AT ISSUE
  Text: ______________________  Source: ______________
  Is it genuinely ambiguous?  Y / N — why: ______

DID ANYONE IDENTIFY THE AMBIGUITY AT THE TIME?
 Date | Who | Document | Where found | What it says
 [ ] Compliance analyst memorandum
 [ ] Policy or coding committee minutes
 [ ] Outside counsel opinion or email
 [ ] Consultant or coding-vendor advice
 [ ] Training materials reflecting the interpretation
 [ ] Payor or contractor correspondence
 [ ] Internal presentations

THE DECISION
  Interpretation adopted: ______________
  By whom: ______  Date: ______  Documented where: ______

CONSISTENCY
  [ ] Applied identically across all sites/units?  Evidence: ____
  [ ] Any departure, and was it corrected? ______

** ADVERSE DOCUMENTS — find them before the government does **
 Document | Author | Date | What it says | Our response
 [e.g., "I know this is aggressive but..."]
 → Was the author involved in the interpretation decision?
 → Was the author corrected in writing?
 → Is the practice described the practice adopted?

IF THERE IS NO CONTEMPORANEOUS FILE: say so internally now, and
plan accordingly. This is a serious problem, not a gap to paper.

Annotation. The last line matters. A company that discovers it has no contemporaneous interpretation record is in a materially weaker position, and the response is to build the defense on materiality and falsity — not to create a memorandum now and date it then. Backfilled documentation is discovered, and it converts a defensible case into a fraud case.

Tool 7 — Materiality record request list

MATERIALITY EVIDENCE — directed at the GOVERNMENT's conduct
[Escobar: payment in full with actual knowledge of noncompliance
 is strong evidence the requirement is NOT material.]

FROM OUR OWN FILES — ** read them; the best document is often
one nobody opened **
 [ ] All audit and review letters from the payor/contractor
 [ ] Sampled records — was the practice VISIBLE in them?
 [ ] Any adjustment made?  [ ] Did payment continue?
 [ ] Correspondence with the agency or contractor about the
     practice
 [ ] Prior self-disclosures and their outcomes

FROM THE AGENCY — request EARLY; these take months
 [ ] FOIA: guidance, manual provisions, and their revision
     history for the requirement at issue
 [ ] FOIA: enforcement actions on this requirement
 [ ] Contractor review and audit findings for our provider/
     contract number
 [ ] Claims payment and denial history
 [ ] Any advisory opinion or coverage determination

INDUSTRY EVIDENCE
 [ ] Was the practice common and known to the agency?
 [ ] Trade association guidance; conference materials
 [ ] Published payer policies

ANALYSIS
  Did the agency know?  When?  How do we prove it? ______
  Did it keep paying?  ______
  Was the requirement ever enforced against anyone? ______
  ** Materiality is NOT established merely because the government
     could have declined payment, or because the requirement was
     labeled a condition of payment. **

Annotation. Send the external requests in the first thirty days. Freedom of Information Act responses and contractor record productions routinely take three to six months, and this evidence is what you present to the government at the intervention decision — which may come sooner than the records do if you wait.

Tool 8 — Jurisdictional bar research memorandum

BARS AND LIMITATIONS — [Matter] — PRIVILEGED

FIRST-TO-FILE — § 3730(b)(5)
  Earlier-filed actions against us, any district: ______
  Sources searched: unsealed dockets · settlement announcements ·
  press · agency actions
  Same ** essential facts **?  Analysis: ______

PUBLIC DISCLOSURE — § 3730(e)(4)
  DISCLOSURE INVENTORY
   Source type | Item | Date | Does it disclose substantially the
   same allegations or transactions?
   [ ] Federal criminal/civil/administrative hearing where the
       Government or its agent was a party
   [ ] Congressional, GAO, or other federal report, hearing,
       audit, or investigation
   [ ] News media
  ** WHICH VERSION OF THE BAR APPLIES?  Determined by WHEN the
     conduct occurred. ** Graham County construed the
     pre-amendment text broadly; Congress narrowed it
     prospectively.
  ORIGINAL SOURCE analysis (Rockwell — focus on the allegations
  ultimately PROVED):
   [ ] Did the relator voluntarily disclose to the Government
       BEFORE the public disclosure?
   [ ] Is the relator's knowledge INDEPENDENT OF and does it
       MATERIALLY ADD TO the disclosure?

LIMITATIONS — § 3731(b)
  Earliest conduct at issue: ______
  6-year period runs from: ______
  3-year discovery period — who is the responsible US official
  and when did they know? ______
  ** 10-year outer limit; Cochise makes the discovery rule
     available in DECLINED cases and the relator is not the
     "official." Assume 10 years. **

Annotation. The bolded line about which version of the public disclosure bar applies is a real trap. The 2010 amendments changed the provision materially and prospectively, so a case spanning conduct before and after the amendment may be governed by different tests for different claims. Fix the operative text before writing the brief.

Tool 9 — Government presentation outline

PRESENTATION TO DOJ — [Matter] — [Date]
** The government, not the relator, is the audience. **

FORMAT: in person, ~60-90 minutes, with a written submission that
can circulate internally after we leave. Documents, not narrative.

I.   WHO WE ARE — two minutes, no more

II.  THE PROCESS — how a claim is actually generated (Tool 5)

III. ** SCIENTER: WHAT WE BELIEVED, AND WHEN **
     Exhibit A: the [date] interpretation memorandum
     Exhibit B: outside counsel advice
     Exhibit C: evidence of consistent application
     [After Schutte, scienter is subjective. This is the record.]

IV.  ** MATERIALITY: WHAT THE AGENCY KNEW AND DID **
     Exhibit D: audit letters showing the practice in sampled
                records
     Exhibit E: no adjustment; payment continued
     [Escobar: payment with actual knowledge is strong evidence
      of immateriality.]

V.   THE WEAK FACTS — ** address them here, in our own words **
     [The bad email; the departure; the unresolved complaint.]
     Why they do not change the analysis: ______

VI.  THE BARS AND LIMITATIONS, if applicable (Tool 8)

VII. WHAT WE ARE ASKING FOR
     [ ] Declination
     [ ] Intervention for the purpose of dismissal under
         § 3730(c)(2)(A) — Polansky: courts grant these in all
         but the most exceptional cases

ATTENDANCE
  [ ] Line AUSA  [ ] Agency counsel — ** include where the
      defense rests on agency guidance or payment practice **
  [ ] Our counsel  [ ] A company witness?  (decide deliberately)

RISKS ACCEPTED: educating the government · revealing defenses ·
prompting new questions · availability to any criminal component

Annotation. Section V is what separates a credible presentation from a discounted one. Government attorneys have the relator's disclosure statement and know the bad facts. A presentation that omits them signals either ignorance of the record or an attempt to mislead, and either conclusion ends the meeting's usefulness.

Tool 10 — Motion to dismiss framework

MOTION TO DISMISS — ORDER THE GROUNDS BY STRENGTH

1. ** RULE 9(b) PARTICULARITY ** — frequently the most efficient
   [ ] Does our circuit require pleading REPRESENTATIVE CLAIMS,
       or accept a scheme + reliable indicia of submission?
       Rule in this circuit: ______________
   [ ] What the complaint fails to plead: who, what, when, where,
       how; identification of any actual claim
2. MATERIALITY (Escobar)
   [ ] No facts pleaded showing a natural tendency to influence
       payment
   [ ] Government payment practice apparent from the complaint or
       judicially noticeable
   [ ] "Condition of payment" label insufficient
3. FALSITY
   [ ] Regulatory noncompliance ≠ false claim
   [ ] Dispute over clinical judgment / contract interpretation /
       a reasonable estimate is not fraud
4. SCIENTER
   [ ] No facts pleaded about what THIS defendant believed
5. PUBLIC DISCLOSURE BAR — § 3730(e)(4)  (Tool 8)
6. FIRST-TO-FILE — § 3730(b)(5)
7. LIMITATIONS — § 3731(b)
8. Reverse false claim: no "obligation" as defined

COUNTERCLAIMS — ** caution **
 [ ] A counterclaim that would penalize the relator for bringing
     the action is generally impermissible
 [ ] Independent wrongs (document theft, confidentiality breach)
     are sometimes viable — and hand the relator a retaliation
     narrative. Judgment call, escalated.

Annotation. Ordering matters more here than in most motions. Courts resolve FCA motions on the cleanest available ground, and a Rule 9(b) dismissal — often with leave to amend, but sometimes not — costs the relator far more than a merits ruling costs the defendant. Lead with it where the circuit's rule is favorable.

Tool 11 — Relator disclosure statement outline

WRITTEN DISCLOSURE OF MATERIAL EVIDENCE AND INFORMATION
Served on the United States pursuant to 31 U.S.C. § 3730(b)(2)

** This document, more than the complaint, drives the
   intervention decision. **

I.    THE RELATOR
      Position, tenure, responsibilities, and ** how the relator
      came to know these facts ** (direct and independent
      knowledge matters for original-source purposes)

II.   THE DEFENDANT AND THE PROGRAM
      Business, federal payor relationship, volume, claim types

III.  THE SCHEME
      What was done · when it started · who directed it · who
      knew · how it worked, step by step

IV.   ** THE CLAIMS **
      How claims were generated and submitted · representative
      examples with identifiers · estimated volume and value ·
      the certification relied upon

V.    FALSITY — why the claims were false or misleading

VI.   ** KNOWLEDGE ** — evidence of what the defendant actually
      believed (post-Schutte, this is the case)
      Documents · statements · internal complaints and responses

VII.  ** MATERIALITY ** — why this requirement mattered to
      payment; anticipate and address the Escobar problem of
      continued agency payment

VIII. DAMAGES — methodology and estimate

IX.   EVIDENCE INVENTORY
      Documents in the relator's lawful possession · how obtained
      · witnesses and what each would say

X.    ** WEAKNESSES ** — the bars, the limitations, the
      unfavorable facts, the alternative explanations
      [A disclosure that overstates loses credibility with the
       only audience that matters.]

Annotation. Section X is the section relators' counsel are most reluctant to write and the one that most improves the chance of intervention. Government attorneys evaluate hundreds of these; the ones that acknowledge the public disclosure problem and explain why the original-source exception applies read as reliable, and reliability is what earns a serious look.

Tool 12 — Settlement term sheet and retaliation protocol

FCA SETTLEMENT — NEGOTIATE IN THIS ORDER

1. ** THE DAMAGES BASE **  (every dollar removed is removed 3×)
   Government's measure (gross): $________
   Our measure (benefit of the bargain, crediting value
   delivered): $________
   Agreed single damages: $________

2. THE MULTIPLIER
   Statutory: 3× + per-claim penalty (§ 3729(a)(1))
   Settlement multiple sought: ____×   Basis: conduct ·
   cooperation · ability to pay · litigation risk
   [§ 3729(a)(2): not less than 2× where all known information
    was furnished within 30 days, with full cooperation, before
    any investigation]

3. RELATOR'S SHARE AND FEES — separate line items
   Share under § 3730(d): ____%
   ** Relator's expenses, attorney fees, and costs FROM THE
      DEFENDANT: $________ **
   [In a small declined case this can exceed the damages.]

4. ** COLLATERAL TERMS — often more consequential **
   [ ] Suspension / debarment; administrative agreement
   [ ] Program exclusion release
   [ ] ** Corporate integrity agreement ** — term ___ yrs;
       independent review organization; reporting; executive
       certifications
   [ ] Negotiated with DIFFERENT government components

5. SCOPE OF RELEASE
   Conduct ______ · period ______ · entities ______ ·
   claims ______
   ** RESERVED: criminal, tax, administrative claims **

6. RECITALS — the press release is what the market reads

7. INDIVIDUALS — addressed expressly, or expressly not

RETALIATION RESPONSE — § 3730(h)

IMMEDIATELY
 [ ] Freeze adverse action against anyone who raised a concern
 [ ] Legal review required for ANY personnel decision touching
     such a person
 [ ] Reconstruct pre-complaint history: reviews, discipline,
     compensation, reorg plans ** predating ** the protected
     activity

UNDERSTAND
 · Easier to prove than the qui tam — no false claim required;
   "efforts to stop a violation" protects a reasonable but
   mistaken belief
 · Proceeds ** publicly ** while the qui tam is sealed, and its
   discovery is used in the sealed case
 · Relief: reinstatement, ** 2× back pay **, interest, special
   damages including fees

SETTLEMENT
 [ ] Early resolution considered — removes a public proceeding,
     a sympathetic narrative, and a discovery vehicle
 [ ] ** Release must NOT purport to bar participation in the qui
     tam or communication with the government ** — unenforceable,
     and evidence of obstruction

Annotation. Item 4's note that collateral terms are negotiated with different government components is the practical point that surprises first-time defendants. The line attorney negotiating the payment does not control debarment or the integrity agreement, and a settlement agreed on the money can stall for months on terms nobody at the table has authority over. Open those channels early.

Tool 13 — Compliance interpretation memorandum template

INTERPRETATION MEMORANDUM — [Requirement] — [Date]
** The single highest-value compliance document after Schutte. **

1. THE QUESTION
   Requirement: [quote the text] — Source: [statute / regulation /
   manual / contract provision, with citation]
   The ambiguity: ______________________
   Raised by: ______  Date: ______  How: ______

2. THE ANALYSIS
   Reading A: ______  Support: ______
   Reading B: ______  Support: ______
   Agency guidance located: ______________
   Industry practice: ______________
   Prior audits or determinations on point: ______________

3. ADVICE OBTAINED
   [ ] Internal compliance  [ ] Outside counsel — [firm], [date]
   [ ] Coding or reimbursement consultant
   Substance of the advice: ______________

4. ** THE DECISION **
   Interpretation adopted: ______________
   Rationale: ______________
   Decided by: ______  Date: ______
   Approved by: ______

5. IMPLEMENTATION
   [ ] Written policy updated: ______
   [ ] Training delivered: ______ (date, audience)
   [ ] Systems configured: ______
   [ ] ** Applied consistently across ALL sites/units **
   [ ] Monitoring: ______

6. REVISIT
   Triggers: new guidance · audit finding · adverse determination
   Next scheduled review: ______

FILED: ______  Retention: ** longer than 10 years **

Annotation. Two details make this document work. Item 5's consistency requirement, because an interpretation adopted centrally and applied unevenly is evidence that nobody believed it. And the retention line, because the limitations reach under § 3731(b) can be ten years after Cochise Consultancy, Inc. v. United States ex rel. Hunt, 587 U.S. 262 (2019) — and a routine seven-year retention schedule destroys the company's best defense exactly when it becomes relevant.

Related documents

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