Corporate Integrity Agreement

A Corporate Integrity Agreement (CIA) is a negotiated compliance framework HHS-OIG enters with a healthcare entity, typically in connection with a False Claims Act settlement, as an alternative to permissive exclusion. The CIA imposes 5-year obligations including a compliance officer and committee, written standards and policies, training, an independent review organization (IRO) to audit claims and arrangements, internal reporting structures, and detailed reporting to OIG.

How a Corporate Integrity Agreement works

CIA negotiation runs in parallel with FCA settlement negotiation. After the settlement amount is largely set, OIG presents draft CIA terms and the parties negotiate the operational obligations: the compliance officer's reporting line, the scope of the IRO's annual claims and arrangements review, the training curriculum, the disclosure obligations to OIG, and the reportable event mechanics. The IRO is independent of the entity and reports to both OIG and the entity. The CIA period is typically 5 years and runs from the effective date set in the agreement.

Operationally, the entity implements the compliance program required by the CIA, undergoes annual IRO claims review (often on a sample of high-risk claim categories), undergoes annual IRO arrangements review (focused on physician compensation, referral relationships, and other AKS or Stark risk areas), and submits annual reports to OIG. Material breaches can trigger stipulated penalties (typically $1,000 to $50,000 per breach) and, for material noncompliance, exclusion of the entity from federal programs.

When a Corporate Integrity Agreement applies

CIAs typically accompany an FCA settlement at the federal level where OIG has identified permissive exclusion grounds (often based on subsection 1320a-7(b)(7) for FCA-based liability) but the entity is too operationally important to exclude. Smaller-scale Integrity Agreements (IAs) apply to less complex matters. CIAs are also negotiated in connection with state Medicaid settlements where state authorities and OIG coordinate. The terms are public and posted on the OIG website.

The entity's exposure under a Corporate Integrity Agreement

Operational cost is substantial: full-time compliance personnel, IRO fees (often six- to seven-figures annually), board-level oversight, training programs, and significant management attention for the full 5-year period. Procedural exposure includes stipulated penalties for noncompliance and the underlying threat of exclusion for material breach. Strategic exposure runs to corporate transactions: a CIA is a public document that affects M&A diligence, lender covenants, and payor credentialing for the duration of the agreement. The defense framework focuses on negotiating workable terms during settlement, building a compliance program that can actually deliver on CIA obligations, and managing the IRO relationship to produce clean annual reports.

Related terms

• OIG exclusion The administrative action a CIA is negotiated to avoid.
• False Claims Act The civil statute whose settlements typically include a CIA.
• OIG self-disclosure The pre-investigation mechanism that can resolve smaller matters without a CIA.
• Anti-kickback statute The criminal statute whose AKS-FCA settlements often produce CIAs focused on arrangements review.

See also

• Practice area
  Healthcare Fraud Defense

  The full healthcare fraud defense framework, including CIA negotiation as part of FCA settlement strategy.

• Practice area
  False Claims Act Defense

  FCA defense framework where CIA negotiation runs alongside dollar-figure settlement negotiation.