Program Integrity—medicare and State Health Care Programs

Scope and purpose.

This section defines the authority and scope of the OIG to exclude individuals and entities from federal health care programs.

Exclusion of entities owned or controlled by a sanctioned person.

The OIG may exclude entities that have ownership or control interests held by individuals who have been sanctioned or convicted of specific offenses.

Basis for liability.

The OIG will exclude individuals or entities convicted of criminal offenses related to health care delivery, patient abuse, or financial misconduct.

Length of exclusion.

This section establishes the minimum 5-year exclusion period and defines aggravating and mitigating factors for determining the length of exclusion.

Failure to disclose certain information.

The OIG may exclude entities that fail to provide required disclosures regarding ownership and control interests.

Failure to provide payment information.

The OIG may exclude entities that fail to provide necessary payment information or refuse to permit record examination for verification.

Failure to grant immediate access.

The OIG may exclude individuals or entities from federal health care programs for failing to grant immediate access to authorized agents for surveys, reviews, or investigations.

Violations of PPS corrective action.

The OIG may exclude a hospital that fails to substantially comply with a corrective action plan required by CMS under the Prospective Payment System.

Default of health education loan or scholarship obligations.

The OIG may exclude individuals from federal health care programs who are in default on health education loans or scholarship obligations.

Exclusion of individuals with ownership or control interest in sanctioned entities.

The OIG may exclude individuals who hold ownership or control interests in, or are officers of, entities that have been sanctioned or excluded from federal health care programs.

Making false statements or misrepresentation of material facts.

The OIG may exclude individuals or entities that knowingly make false statements or misrepresent material facts in applications or contracts to participate in federal health care programs.

Violations of the limitations on physician charges.

The OIG may exclude physicians who repeatedly bill Medicare beneficiaries in excess of the maximum allowable charges.

Billing for services of assistant at surgery during cataract operations.

This provision outlines the criteria for OIG exclusion regarding the improper billing of assistant-at-surgery services for cataract operations.

Waivers of exclusions.

This provision establishes the authority and criteria for the OIG to grant or deny waivers of program exclusions for specific individuals or entities.

Scope and effect of exclusion.

This provision defines the scope of OIG exclusions and the prohibition on payment for items or services furnished by excluded individuals or entities.

Definitions.

For purposes of this part:

Notice of intent to exclude.

This provision outlines the OIG's process for providing written notice of intent to exclude an individual or entity from federal health care programs.

Notice of exclusion.

This provision details the requirements for the OIG to issue a formal notice of exclusion to an affected individual or entity.

Notice of proposal to exclude.

This provision specifies the procedures for the OIG to issue a notice of proposal to exclude, including the timeline for requesting a hearing.

Notice to State agencies.

This provision requires HHS to notify state agencies of the facts and circumstances of an exclusion and the required period of state-level exclusion.

Notice to State licensing agencies.

This provision mandates that HHS notify state licensing or certification authorities of an exclusion to facilitate potential state-level sanctions.

Notice to others regarding exclusion.

This provision outlines the entities and organizations that HHS must notify regarding an exclusion, including hospitals and professional organizations.

Appeal of exclusions.

This provision outlines the procedures and standards for an individual or entity to request a hearing before an administrative law judge to appeal an OIG exclusion.

Conviction relating to program or health care fraud.

This provision defines the circumstances under which the OIG may exclude an individual or entity convicted of fraud or financial misconduct related to health care programs and specifies factors for determining the length of exclusion.

Timing and method of request for reinstatement.

This provision specifies the requirements and procedures for an excluded individual or entity to submit a written request for reinstatement to the OIG.

Basis for reinstatement.

This provision outlines the criteria the OIG uses to determine whether to authorize the reinstatement of an excluded individual or entity into federal health care programs.

Approval of request for reinstatement.

This provision details the notification and administrative actions the OIG takes upon approving a request for reinstatement into federal health care programs.

Denial of request for reinstatement.

This provision outlines the procedures for an excluded individual or entity to challenge a denial of a reinstatement request and the OIG's process for reviewing such challenges.

Withdrawal of exclusion for reversed or vacated decisions.

This provision specifies the conditions under which an OIG exclusion is withdrawn and an individual or entity is retroactively reinstated following a reversed or vacated conviction or administrative action.

Conviction relating to obstruction of an investigation or audit.

This provision defines the circumstances under which the OIG may exclude an individual or entity convicted of interfering with or obstructing an investigation or audit related to federal health care programs.

Conviction relating to controlled substances.

The OIG may exclude individuals or entities convicted of misdemeanors related to the unlawful manufacture, distribution, prescription, or dispensing of controlled substances.

License revocation or suspension.

The OIG may exclude individuals or entities whose professional health care license has been revoked, suspended, or surrendered due to professional competence or integrity issues.

Exclusion or suspension under a Federal or State health care program.

The OIG may exclude individuals or entities that have been sanctioned, suspended, or excluded from other Federal or State health care programs.

Excessive claims or furnishing of unnecessary or substandard items and services.

The OIG may exclude individuals or entities that submit excessive claims or provide items or services that are unnecessary or fail to meet professional standards of care.

Failure of HMOs and CMPs to furnish medically necessary items and services.

The OIG may exclude HMOs and competitive medical plans from federal health care programs for failing to provide medically necessary services required under their contracts.

False or improper claims.

The OIG may exclude individuals or entities that commit acts described in section 1128A of the Act, such as submitting false or improper claims.

Fraud and kickbacks and other prohibited activities.

The OIG may exclude individuals or entities that knowingly and willfully solicit, receive, offer, or pay remuneration in violation of the anti-kickback statute.

Exceptions.

The following payment practices shall not be treated as a criminal offense under section 1128B of the Act and shall not serve as the basis for an exclusion: