The OIG (Office of Inspector General) has updated their “Criteria for implementing section 1128(b)(7) exclusion authority.”
Here is a link to the OIG write up about the new standards. https://oig.hhs.gov/exclusions/files/1128b7exclusion-criteria.pdf
The OIG has a mission “to protect the integrity of Department of Health & Human Services (HHS) programs as well as the health and welfare of program beneficiaries.” To fulfil this mission the OIG creates resources to help the health care industry comply with the Nation’s Fraud laws. They also work to educate the public, to protect them from fraud, and to have the public report suspicious activities. The Office of Counsel to the Inspector General (OCIG) is responsible for imposing program exclusions and civil monetary penalties (CMP) on health care providers. The excluded health care providers are included on a list known as the List of Excluded Individuals/Entities (LEIE). This article will summarize the current method the OIG uses in determining the action taken against an individual or entity.
The OIG will be using a scale to determine the action taken, ranging from Exclusion to imposing Integrity Obligations to Release. There are a number of factors included in the risk assessment, which then determine the course of action the OIG will take. The categories included in this evaluation are; The Nature and Circumstance of the Conduct, Conduct During the Investigation, Significant Ameliorative Efforts, and History of Compliance.
Factors applied to determine the action taken
These Factors have an impact on the risk assessment, they indicate a higher risk, a lower risk, or can be neutral in determining what action will be taken by the OIG. Here is a quick summary
- Nature and Circumstance of Conduct
- If the conduct had an adverse impact on Individuals
- Financial loss- the greater the amount of loss or intended loss to the Federal healthcare programs the greater the risk assessment.
- Conduct that occurs as part of a pattern, or over a period of time, or is continual or repeated indicates a higher risk
- Conduct that is currently ongoing or was continued until the Government began an investigation leads to a higher risk
- A lack of criminal sanctions has no impact on the level of risk
- Leadership Role- if the individual organized, led or planned the unlawful activity
- History of Prior Fraudulent Conduct, including prior judgements or convictions, refusal to enter into a Corporate Integrity Agreement (CIA), having a prior CIA, and failing to cooperate with OIG while under a CIA all indicate higher risk levels
- Conduct during Investigation
- Overall response to the investigation
- Did the individual obstruct or impede the investigation or attempt to do so?
- Was anything done to conceal the conduct from the government
- The inability for a person to engage in the conduct again for whatever reason has no effect on the risk assessment
- While a prompt response to the subpoena has no effect, failure to comply within a reasonable time frame would result in a higher risk assessment.
- Internal Investigation
- If an internal investigation began prior to the individual or entity learning about the Government’s investigation, and any information gained as a result is shared with the government, risk will be lower.
- If the person self-disclosed the conduct prior to the Government’s investigation, this would also result in a lower risk assessment.
- If the person cooperates with the Government the risk assessment is lower.
- If through the person’s cooperation a criminal, civil, or administrative action is taken against an individual or entity, then risk assessment is lower.
- Adverse Licensure action increases the risk
- A criminal resolution including either a conviction, a Deferred Prosecution Agreement, or a Non-Prosecution Agreement. Any of these actions will increase risk which varies depending on the type of criminal action taken
- Significant Ameliorative Efforts
- Significant changes in the entity
- The entity taking appropriate action against the individual lowers risk.
- If the entity has dedicated more resources to insure compliance this will also lower the risk.
- If after the conduct has stopped, the entity has been sold to a non-affiliated, independent third party that has a history of compliant participation in Federal healthcare programs, the risk will be lower
- If there has been additional training, or a mentor assigned or other mitigating steps have been taken that will also lower the risk assessment.
- History of Compliance
- If the person has a history of appropriate timely self-disclosure made in good faith the risk will be lower
- Having a compliance program in place has no impact on risk level, but not having a compliance program in place that incorporates the U.S. Sentencing Commission Guidelines Manual’s seven elements of an effective compliance program will increase the risk.
This new criteria helps clarify the process for how a health care provider can find themselves excluded by the OIG. If an individual or entity is on the LEIE, then “no payment will be made by any Federal health care program (ie; medicare or medicaid) for items or services furnished, ordered, or prescribed by the excluded individual in any capacity.” The OIG can impose penalties on entities and individuals who bill the Federal government for services while excluded by the OIG. These Civil Monetary Penalties (CMP) can be up to $10,000.00 per occurrence plus treble damages.
At Typhoon Data one of our services is to verify that providers are not on the LEIE. We offer a variety of services to help maintain compliance.
If you would like to discuss our solutions, feel free to contact me, David Rees at (800) 780-5901 Ext 705 or email firstname.lastname@example.org.