OIG Self-Disclosure · SDP · CIA · IRO · Settlement Negotiation

OIG Self-Disclosure Counsel

Counsel for providers navigating the HHS-OIG Self-Disclosure Protocol, settlement, and CIA obligations.

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OIG Self-Disclosure Counsel Briefing

Investigations and Defense Scope

The HHS-OIG Self-Disclosure Protocol (SDP) and the parallel DOJ corporate disclosure framework can convert a multi-year prosecution into a multi-month settlement. The same protocols are catastrophic for organizations that disclose before scoping the conduct adequately.

The decision to self-disclose is binary, time-limited, and irreversible. The judgment of when, what, and how to disclose is the entire engagement.

Health Law Alliance counsels healthcare operators considering or executing self-disclosure across the SDP framework, including scoping, settlement negotiation, and the Corporate Integrity Agreement (CIA) and Independent Review Organization (IRO) obligations that follow most resolved disclosures, in lieu of OIG exclusion. Engage privileged counsel before any disclosure is contemplated.

2,500+
Clients Represented
96%
Reduction of a $4.7M OptumRx Demand
2,000+
Audits Overseen by Our Bench
Immediate
Response - Audit Notices Don't Wait
"By the time the audit letter arrives, you have 30 days. The pharmacies that win are the ones that mobilize in the first 72 hours."
Protect Your Pharmacy Now →
Illustrative stack of legal and medical records prepared for document review
Document review · Illustrative image, not a client record
Document Review

The first production shapes the government’s theory

A subpoena or civil investigative demand sets the government’s starting record. What is produced, what is withheld as privileged, and what is preserved shapes the theory investigators build.

Demand and deadlineIdentify whether the matter is a grand jury subpoena, a civil investigative demand, or an agency request, and protect the response window.
Custodians and preservationConfirm where responsive records live and issue a litigation hold before anything is lost.
Privilege and scopeReview the demand’s scope and the privilege posture before producing a record that cannot be taken back.
The HLA Defense Process
A four-stage defense protocol

Our bench includes a former federal prosecutor who served as Chief Compliance Officer of UnitedHealth Group, OptumRx’s parent company.

  • Notice triage & deadline lock
  • Chart-level defense build
  • Level-1 & Level-2 appeal response
  • Litigation & regulatory containment
Signing settlement document
Resolution
01
Notice triage & deadline lock

Within 24 hours: parse every deadline in the audit notice, place a litigation hold on the claims at issue, and preserve adjudication logs before the PBM rotates them out.

02
Chart-level defense build

Claim-by-claim reconstruction: prescriber PA rationale, plan criteria at time of fill, BMI/A1C/comorbidity support, step-therapy chain, and compounding regulatory posture. Every flagged script gets its own defense memo.

03
Level-1 & Level-2 appeal response

We draft and file the written appeal, quantify the PBM's extrapolation errors, and negotiate directly with the auditor and network relations.

04
Litigation & regulatory containment

If the PBM refuses a reasonable resolution, we file in federal court and pair the suit with regulatory defense at DEA, FDA, and the state board - so a PBM dispute does not escalate into a license action.

Health Law Alliance attorneys
The HLA Bench

The HLA OIG Self-Disclosure Counsel Team

Health Law Alliance handles the response and any parallel appeal, licensing matter or referral as one coordinated matter, so the strategy does not change hands as the matter moves between forums.

The bench includes a former Assistant U.S. Attorney nominated for the DOJ Director's Award, senior healthcare-company counsel, and attorney-providers with experience across healthcare audits and investigations.

Health Law Alliance

Firm record

5,000+Matters handled
2,500+Clients represented
2,000+Audits overseen
ImmediateAttorney response
Former professional experience

Where Our Attorneys Served Before Health Law Alliance

Department of Justice Former Assistant U.S. Attorney
Drug Enforcement Administration Former DEA Diversion Program Manager
UnitedHealth Group Former Chief Compliance Officer
McKesson Former Chief Counsel and Vice President

Agency and company marks identify former professional experience of individual HLA team members. They do not imply affiliation, endorsement, or a client relationship.

Speak with an Attorney Today

Get a free, privileged review of your matter before you respond

Before you write a single page of your written response, have a privileged conversation with attorneys who have overseen 2,000+ audits - from both sides of the table. Free, confidential, no retainer.

Under audit? Speak with an attorney today.