The OIG has the authority to exclude any individual or entity (collectively, “person”) from participation in Federal health care programs for engaging in conduct prohibited by sections 1128A or 1128B of the Social Security Act. After the OIG makes a determination of exclusion, the person will be added to the OIG’s List of Excluded Individuals and Entities (LEIE). All providers of Medicare and Medicaid-related services must periodically sanction screen individuals and entities with whom they engage or do business. Sanction screening entails screening these parties against the LEIE and maintaining evidence that ongoing screening occurs as required. In April 2016, the OIG updated its criteria for implementing exclusion authority. The OIG often concludes 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). CIAs are designed to strengthen compliance programs and to promote compliance so that future issues can be prevented or identified, reported, and corrected. Additionally, CIAs enhance the OIG’s oversight with particular persons. The OIG weighs various factors when determining whether to pursue exclusion, enter into a CIA, or provide an exclusion release without integrity obligations. In making this determination, the OIG considers the following:
Factors Increasing Risk of Sanctioning
- Nature and Circumstances of Conduct. Whether conduct causes or can potentially cause an adverse impact on individuals, 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; (b) occurred over a substantial period of time; (c) was continual or repeated misconduct; or (d) continued to occur 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. If a person has a history of judgments, convictions, decisions, or settlements in prior federal or state criminal, civil, or administrative enforcement actions. Additionally, whether a person (a) refused to enter into a CIA; (b) breached a prior CIA; or (c) lied or failed to cooperate with the OIG while under a CIA.
- Conduct During Investigation. Whether the person (a) obstructed or impeded, or attempted to obstruct or impede, the investigation, audit, or internal or external reporting of the unlawful conduct; (b) took any steps to conceal the conduct from the government or others; or (c) failed to comply with a subpoena within a reasonable amount of time.
- Resolution. Whether, as result of conduct, there is an adverse licensure action, a criminal conviction, a deferred Prosecution Agreement, or a Non-Prosecution Agreement; or if there is an inability to pay an appropriate monetary amount (including damages, assessments, and penalties) to resolve a fraud case.
- Absence of a Compliance Program. If a compliance program incorporating the seven elements of an effective compliance program is absent.
Factors Lowering Risk of Sanctioning
- Internal Investigation. If, prior to government involvement, the person initiated an internal investigation to determine who was responsible for the conduct and shared the results of such an investigation with the government. Additionally, if the person self-disclosed the conduct cooperatively and in good faith as a result of the internal investigation and clearly accepts responsibility for the conduct.
- Cooperation. If the person cooperated with or agreed to cooperate with the government and if the person’s cooperation 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 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. If, 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 programs.
- Dependency of the Community. Whether 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.