What Does it Mean To Be On the HHS OIG Exclusion List?
If an individual or organization is on the HHS OIG Exclusion List, it means they been excluded from participating in Federally funded healthcare programs such as Medicare and Medicaid; and not only can they not bill the programs directly for goods or services, their goods or services cannot be acquired by any other healthcare provider that participates in a Federal healthcare program.
In 1977, the Medicare-Medicaid Anti-Fraud and Abuse Amendments mandated that healthcare practitioners who were convicted of a criminal offense against Medicare or Medicaid (i.e., under the False Claims Act) should be excluded from participating in Medicare and Medicaid “for such period as [the Secretary for Health and Human Services] deems appropriate”.
The exclusion clause (§1128A of the Social Security Act) was extended by the Civil Monetary Penalties Law in 1981 to cover all individuals and organizations that submit false, fraudulent, or otherwise improper claims to Medicare or Medicaid; and extended again by HIPAA in 1996 to prohibit excluded individuals and organizations from participating in any Federal healthcare program.
In the context of what does it mean to be on the HHS OIG Exclusion List, possibly the most significant regulatory event occurred in 1997, when the Balanced Budget Act authorized civil monetary penalties and potential exclusion against healthcare providers that acquired goods or services from individuals or organizations that appeared on the HHS OIG Exclusions List.
HHS OIG Exclusions List
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How Does Someone Get On the HHS OIG Exclusion List?
Subsequent amendments to the Civil Monetary Penalties Law have increased the number of ways in which someone can get on the HHS OIG Exclusion List. Whereas in 1981, individuals and organizations would only be excluded for false claims against Medicare and Medicaid, there is a long list of offenses that can result in exclusion from Federal healthcare programs.
These include, but are not limited to, patient abuse or neglect in care homes and other long term healthcare facilities, unlawfully manufacturing, distributing, prescribing, or dispensing a controlled substance, and failing to evaluate and stabilize a patient in an emergency situation in violation of the Emergency Medical Treatment and Active Labor Act (EMTALA).
In September 2023, two more ways somebody could get on the HHS OIG Exclusion List were added – failing to grant timely access to OIG for the purposes of audits, investigations, evaluations, or other statutory functions, and any information blocking practices – including the development of software – that is likely to interfere with, prevent, or discourage the use of electronic health information.
How Long Does an HHS OIG Exclusion Remain in Force?
Although the 1977 Medicare-Medicaid Anti-Fraud and Abuse Amendments gave HHS OIG the discretion to apply exclusions “for such period as deem[ed] appropriate”, minimum exclusion periods are now mandated for certain offenses. For example, Medicare fraud, elder abuse, and unlawfully dispensing a controlled substance carry minimum exclusion periods of five years.
“Permissive Exclusions” for lesser offences are discretionary. For example, OIG HSS can enforce a “baseline” exclusion period of three years for obstructing access in an audit or investigation or violating EMTALA, but does not have to if the individual or organization agrees to comply with a monitored Corporate Integrity Agreement (which usually lasts three years anyway).
Variations to the length of an HHS OIG exclusion can also depend on whether an offense has been pursued as a civil or criminal matter. For example, if an individual is found guilty of a civil violation of the HHS OIG anti-kickback regulations, there is no minimum exclusion period stipulated. However, if the offense is pursued as a criminal matter, the minimum exclusion period is five years.
What are the Penalties for Acquiring Goods or Services from an Excluded Entity?
Since the Balanced Budget Act of 1997, healthcare providers that acquire goods or services from an excluded individual or organization, and subsequently claim payment from a Federal healthcare program for the goods and services, can be fined up to $20,000 for each good or service claimed plus three times the amount claimed. They may also be excluded themselves.
For this reason HHS OIG recommends healthcare providers review the Exclusions List prior to contracting a vendor to supply goods or engaging a new member of the workforce. The List should be reviewed periodically thereafter for additions to the List and – since September 2023 – this recommendation also applies to goods or services acquired from a software vendor or SaaS service provider.
