The OIG has authority to exclude any individual or entity (collectively, “person”) from participation in the Federal health care programs for engaging in conduct prohibited by sections and add them to their List of Excluded Individuals and Entities (LEIE). All providers of Medicare and Medicaid related services must periodically sanction-screen those who they engage or with whom they do business against that listing; and maintain evidence of having done this. The OIG updated their “Criteria for implementing Exclusion Authority”. They often conclude that exclusion is not necessary to protect the Federal health care programs if the person agrees to appropriate integrity obligations under a Corporate Integrity Agreement (CIA) that is designed to strengthen a person’s compliance program and promote compliance so that future issues can be prevented or identified, reported, and corrected, as well as enhanced OIG’s oversight. The OIG weighs various factors in determining whether to pursue exclusion, enter into a CIA, or possibly provide an exclusion release without integrity obligations. In making these determinations, the OIG considers the following:
Factors Increasing Risk of Sanctioning
- Nature and Circumstances of Conduct. Adverse impact on individuals by the conduct, such as the potential to cause any adverse physical, mental, financial, or other impact to program beneficiaries, recipients, or other patients.
- Financial Loss. Whether conduct (a) was part of a pattern of wrongdoing indicates; (b) over a substantial period of time; (c) continual or repeated misconduct; and (d) continued to engage in until or after the person learned of the Government’s investigation indicates higher risk.
- Leadership Role. If the individual organized, led, or planned the unlawful conduct.
- History of Prior Fraudulent Conduct. A person’s history of judgments, convictions, decisions, or settlements in prior federal or state criminal, civil, or administrative enforcement actions. Also, (a) refusal to have entered into a CIA, (b) breached a prior CIA, or (c) lied or failed to cooperate with OIG while under a CIA.
- Conduct During Investigation. If the person obstructed or impeded, or attempted to obstruct or impede, the investigation, audit, or internal or external reporting of the unlawful conduct; taken any steps to conceal the conduct from the Government or others; or (c) failure to comply with a subpoena.
- Resolution. When as result of conduct there is an adverse licensure action, a criminal conviction, deferred Prosecution Agreement, or a Non-Prosecution Agreement. Also, the inability to pay an appropriate monetary amount (including damages, assessments, and penalties) to resolve a fraud case.
- Absence of Compliance Program. Absence of a compliance program that incorporates the seven elements of an effective compliance program.
Factors Lowering Risk of Sanctioning
- Internal Investigation. Prior to Government involvement, person initiated an internal investigation and shared the results of the investigation; Individuals who self-disclosed the conduct cooperatively and in good faith as a result of the internal investigation. Person clearly demonstrates acceptance of responsibility for the conduct.
- Cooperation. Person cooperated with or agreed to cooperate with the Government; and if this resulted in a criminal, civil, or administrative action or resolution with or against other individuals or entities.
- Significant changes within the entity. If the entity has taken appropriate disciplinary action against individuals responsible for the conduct, or has devoted significantly more resources to the compliance function. If a licensed individual has obtained relevant additional training, retained a proctor or a mentor, or took similar steps to improve his or her ability to practice as a provider of health care items or services to the Federal health care programs. If the person has a history, prior to becoming aware of the investigation, of significant self-disclosures made appropriately and in good faith to OIG, CMS (for Stark law disclosures), or CMS contractors (for non-fraud overpayments).
- Changes of Ownership. When, at the end of the conduct at issue, the entity has been sold in an arm’s-length transaction to a non-affiliated, independent third party with a history of compliant participation in the Federal health care
- Dependency of the Community. The person is a sole source of essential specialized items or services in a community or provides items or services for which there are no alternative or comparable sources. This factor will weigh in favor of OIG pursuing remedies other than exclusion.