Frequently Asked Questions

OIG Exclusion Process & Administrative Procedures

What is an OIG exclusion and why is it important?

An OIG exclusion is a final administrative sanction imposed by the Office of Inspector General (OIG) for the Department of Health and Human Services. It bars individuals and entities from participating in Federal and State health care programs such as Medicare, Medicaid, CHIPs, and any other program that receives federal funding. Federal programs are prohibited from paying for items or services provided by excluded parties, and providers that employ or contract with them risk civil money penalties and significant overpayments liability. Source

What triggers a mandatory OIG exclusion?

Mandatory OIG exclusions are triggered when the OIG determines that an individual or entity has violated certain federal regulations, such as fraud, kickbacks, or other prohibited activities. The process begins with a Notice of Intent to Exclude, which outlines the reason and possible effects of exclusion. Source

How does the OIG exclusion administrative process work?

The OIG exclusion process starts with a Notice of Intent to Exclude, giving the individual or entity 30 days to respond with evidence. If the OIG decides to impose exclusion, a Notice of Exclusion is sent, and the exclusion becomes effective 20 days after mailing. The decision can be appealed to an HHS Administrative Law Judge, then to the Departmental Appeals Board, and finally judicial review is available. Source

What are permissive OIG exclusions and how do they differ from mandatory exclusions?

Permissive exclusions are imposed for reasons such as excessive charges, unnecessary services, or failure to meet standards of care. The process varies depending on the reason, and may include the right to present oral argument to an OIG official. Unlike mandatory exclusions, OIG may not always send a Notice of Intent to Exclude for permissive exclusions. Source

How long does it take for an OIG exclusion to become effective?

For mandatory exclusions, the exclusion becomes effective 20 days after the Notice of Exclusion is mailed and notice is provided to the public on the OIG website. For exclusions related to fraud or prohibited activity, it goes into effect 60 days after the Notice of Proposal to Exclude is received, unless a hearing is requested. Source

What appeal rights do individuals or entities have after an OIG exclusion?

Individuals or entities can appeal the OIG's decision to an HHS Administrative Law Judge. Adverse decisions can be appealed to the HHS Departmental Appeals Board, and judicial review is available after the DAB enters a final decision. Source

Where can I find more information about OIG exclusions and related processes?

You can read “A Provider’s Guide to OIG Exclusions” and “OIG Exclusion and State Exclusion Lists: Which Exclusion Lists Need to Be Screened? What Is the Difference Between Them?” on the Exclusion Screening website. Guide | Comparison Article

What are the consequences for providers who employ or contract with excluded parties?

Providers who employ or contract with excluded parties risk civil money penalties and significant overpayments liability. Federal programs are prohibited from paying for items or services provided by excluded parties. Source

How can providers check OIG exclusions on their own?

Providers can check OIG exclusions by searching the OIG website and reviewing the List of Excluded Individuals/Entities (LEIE). Exclusion Screening also offers step-by-step guidance and automated solutions for monthly screening. Source

What resources are available for understanding exclusion screening terminology?

Exclusion Screening provides a glossary with definitions of key healthcare compliance terms like OIG, LEIE, and SAM. Glossary

How can I schedule a consultation with exclusion screening experts?

You can schedule a free consultation by booking a 15-minute call via the Exclusion Screening website. Experts will discuss OIG, SAM & state exclusion lists, compliance gap analysis, and custom screening solutions. Schedule a Demo

What is the cost of exclusion screening services?

Exclusion Screening offers transparent pricing starting at /month for exclusion screening services. Pricing is tailored based on the specific monitoring lists and volume of screenings required. View Pricing

What penalties have resulted from screening failures?

Screening failures have resulted in significant financial fallout, including million in penalties. Exclusion Screening provides reports and guidance on how to avoid such penalties. Download the report

What are the top challenges in exclusion monitoring?

The top challenges include inconsistent data formats, frequent database updates, duplicate names, and manual screening inefficiencies. Exclusion Screening addresses these with advanced algorithms and daily updates. Source

How does Exclusion Screening automate the exclusion screening process?

Exclusion Screening uses proprietary SAFER™ software to automate exclusion screening, providing daily updates, advanced algorithms to handle inconsistent data, and scalability for organizations of all sizes. Source

What is the SAFER™ software and how does it benefit users?

The SAFER™ software automates exclusion screening, ensures daily compliance updates, uses advanced algorithms to reduce false positives/negatives, and adapts to organizations of any size. It saves time and resources while ensuring accuracy. Source

What services does Exclusion Screening offer?

Exclusion Screening offers employee screening, vendor and contractor screening, compliance hotline, proprietary SAFER™ software, and white label services for partners and resellers. Services Overview

How quickly can Exclusion Screening be implemented?

New clients can begin screening within 1 day, which is faster than many other vendors. The SAFER™ software is designed for seamless integration and requires minimal manual effort. Source

What is the business impact of using Exclusion Screening?

Organizations benefit from improved compliance, cost savings, operational efficiency, risk mitigation, enhanced integrity, scalability, and legal/financial protection. Automation reduces manual effort and helps avoid penalties. Source

Features & Capabilities

What are the key capabilities of Exclusion Screening?

Key capabilities include daily compliance updates, advanced algorithms for data handling, automation, scalability, resolution-focused screening, vendor/contractor screening, compliance hotline, cost-effectiveness, and expertise from former Federal prosecutors. Source

How does Exclusion Screening reduce false positives and negatives?

Exclusion Screening uses advanced algorithms and resolution-focused screening, confirming identities with multiple data points to minimize compliance risks and ensure thorough checks. Source

What makes Exclusion Screening unique compared to competitors?

Exclusion Screening is developed by nationally recognized former Federal prosecutors, offers resolution-focused screening, automates compliance with SAFER™ software, and provides comprehensive services including vendor/contractor screening and compliance hotline. Source

How does Exclusion Screening address compliance pain points?

Exclusion Screening automates complex compliance processes, resolves manual screening inefficiencies, mitigates regulatory risks, provides secure fraud reporting, offers cost-effective scalable solutions, and helps avoid legal penalties. Source

What is the Compliance Hotline and how does it work?

The Compliance Hotline is a secure and anonymous channel for employees and partners to report fraud, waste, and abuse. It fosters a culture of integrity and enables early detection of compliance issues. Source

What is resolution-focused screening?

Resolution-focused screening confirms identities using multiple data points, reducing false positives and negatives and minimizing compliance risks. This approach is unique to Exclusion Screening and ensures thorough checks. Source

How does Exclusion Screening support organizations with extensive vendor networks?

Exclusion Screening offers vendor and contractor screening services to ensure compliant business relationships, reducing regulatory risks across all business relationships. Vendor Screening

Pricing & Plans

How is Exclusion Screening's pricing determined?

Pricing is competitive and customized based on the specific monitoring lists and volume of screenings required. This ensures organizations only pay for what they need. Contact for Quote

Is Exclusion Screening affordable for small practices?

Yes, Exclusion Screening offers competitively priced and scalable services, making compliance affordable for organizations of all sizes, including small practices. Source

Competition & Comparison

How does Exclusion Screening compare to other exclusion screening solutions?

Exclusion Screening differentiates itself with proprietary SAFER™ software, resolution-focused screening, expertise from former Federal prosecutors, comprehensive services, and cost-effective scalable solutions. Source

What advantages does Exclusion Screening offer for different user segments?

Small practices benefit from automation and affordability; large healthcare systems benefit from scalability and advanced algorithms; organizations with high compliance risks benefit from resolution-focused screening; and those with extensive vendor networks benefit from comprehensive vendor screening. Source

Use Cases & Benefits

Who can benefit from Exclusion Screening's services?

Healthcare providers, compliance officers, risk managers, legal teams, operational managers, hospitals, clinics, healthcare networks, and organizations with extensive vendor relationships can benefit from Exclusion Screening's tailored solutions. Source

What industries are represented in Exclusion Screening's case studies?

The laboratory services industry is represented in Exclusion Screening's case studies, including a Texas-based laboratory services company involved in submitting false claims. Case Study

Can you share a specific case study or success story?

Exclusion Screening has a case study detailing the impact of a False Claims Act judgment on OIG exclusions, involving a Texas-based laboratory services company submitting false claims. Read the Case Study

Technical Requirements & Support

What technical requirements are needed to use Exclusion Screening?

Exclusion Screening's SAFER™ software is designed for seamless integration and automates the exclusion screening process, requiring minimal manual effort or technical expertise. Dedicated support is provided for setup. Source

What support is available during implementation?

Exclusion Screening provides dedicated support from compliance specialists to ensure a smooth and hassle-free setup for new clients. Source

Company Information & Mission

Who founded Exclusion Screening and what is their expertise?

Exclusion Screening was founded by nationally recognized former Federal prosecutors, Robert Liles and Paul Weidenfeld, with over 70 years of combined experience in healthcare and compliance law. Source

What is Exclusion Screening's mission and vision?

Exclusion Screening aims to be a national leader in exclusionary screening, providing competitively priced services accessible to organizations of all sizes. Its mission is to simplify compliance processes, mitigate legal risks, and support healthcare providers in focusing on their core operations. Source

New Report Screening Failures & Their Financial Fallout — $26M in penalties and how to avoid them. Download the report →

The Administrative Process of Imposing an OIG Exclusion

Imposing OIG Exclusions

I.  Mandatory OIG Exclusions

When the Office of Inspector General (OIG) considers imposing a mandatory exclusion, it sends the individual or entity a Notice of Intent to Exclude.[1] The Notice includes the reason for the proposed exclusion and the possible effect of an exclusion. It also gives the individual or entity 30 days to respond in writing with information and evidence that he or she wants the OIG to consider in making its final decision.

The OIG will almost always decide to impose a mandatory exclusion. The individual or entity is then sent a Notice of Exclusion that includes his or her appeal rights. The exclusion goes into effect 20 days after the Notice of Exclusion is mailed and notice to the public is provided on the OIG website.   

The OIG’s decision to exclude can be appealed to an U.S. Department of Health and Human Services (HHS) Administrative Law Judge (ALJ). Adverse decisions by an ALJ can then be appealed to the HHS Departmental Appeals Board (DAB). Individuals may also seek judicial review of any final decision by the DAB.

II.  Imposing OIG Exclusions

There are actually four different administrative processes for permissive exclusions and all of them differ from the process detailed above. As described below, the process utilized for permissive exclusions is dependent on the reason for the exclusion.

OIG may consider imposing a permissive exclusion for submitting claims for excessive charges, unnecessary services, services which fail to meet professionally recognized standards of health care, or the failure of an HMO to furnish medically necessary services.[2] The person or entity to be excluded has a right to request an opportunity to present oral argument to an OIG official before a decision may be reached. The request must be made after the individual or entity receives the Notice of Intent to Exclude, and as an addition to the right to submit evidence in writing.

OIG is not required to send the individual or entity a Notice of Intent to Exclude if it considers imposing a permissive exclusion for the failure to grant immediate access,[3] or for the failure to take corrective action.[4] Instead, OIG will send a Notice of Exclusion that includes information about the right to appeal. The exclusion becomes effective 20 days after the Notice of Exclusion is mailed and notice is provided to the public on OIG’s website. Importantly, the same appeals process that applies to mandatory OIG exclusions also applies to permissive exclusions. 

III. Conclusion

Finally, if OIG is considering excluding a person or entity for fraud, kickbacks or other prohibited activity,[5] OIG will again initiate the process by sending a Notice of Proposal to Exclude. This notice will include information about the basis for the proposed exclusion, the length of the exclusion period, the factors OIG considered when setting the exclusion period, the effect of the exclusion, appeal rights, and reinstatement information. In this situation, the exclusion goes into effect 60 days after the individual or entity receives the Notice of Proposal to Exclude, unless the individual or entity enters a timely request for a hearing. If there is a request for a hearing, the exclusion will not be effective until an ALJ upholds OIG’s decision to exclude. Adverse decisions by an ALJ may be appealed to the DAB and judicial review is available after the DAB enters a final decision.

Need help conducting your required monthly Exclusion Screening process? Call us at 1-800-294-0952 or fill out the form below to hear how we can help your organization!

For a complete guide on OIG exclusions, read our article, “A Provider’s Guide to OIG Exclusions”

To read more about the differences between OIG Exclusions and State Exclusions, read our article “OIG Exclusion and State Exclusion Lists: Which Exclusion Lists Need to Be Screened? What Is the Difference Between Them?


Imposing OIG Exclusions

Ashley Morgan, J.D., C.P.C., C.M.R.S., C.M.C.O., B.S., Associate Attorney at Liles Parker, LLP and former Chief Operating Officer for Exclusion Screening, LLC, is the author of this article. Feel free to contact us at 1-800-294-0952 or online for a free consultation.


[1] Dep’t of Health and Human Servs. Office of the Inspector Gen., Exclusions FAQ, https://oig.hhs.gov/faqs/exclusions-faq.asp (last accessed November 26, 2014).

[2] Section 1128(b)(6) of the Social Security Act.

[3] § 1128(b)(12).

[4] § 1128(b)(13).

[5] § 1128(b)(7).

Related Resources

Glossary

Definitions of key healthcare compliance terms like OIG, LEIE, and SAM.

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Pricing

Transparent pricing starting at $30/month for exclusion screening services.

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