Frequently Asked Questions

Exclusion Screening Basics & Regulatory Requirements

What is exclusion screening and why is it mandatory for healthcare providers?

Exclusion screening is the process of checking employees, vendors, and contractors against federal and state exclusion lists to ensure none are barred from participating in Medicare or Medicaid programs. It is mandatory because federal and state regulations prohibit payment for any item or service provided, directly or indirectly, by an excluded person. Failure to comply can result in Civil Monetary Penalties (CMPs) and overpayments. Source

What are the consequences of failing to screen for exclusions?

Failing to screen for exclusions can result in Civil Monetary Penalties (CMPs), overpayments, and potential actions under the False Claims Act. Enforcement cases are increasing, and penalties are difficult to defend since the OIG interprets regulations strictly. Source

How often are providers required to conduct exclusion screening?

Providers are required to screen all employees, vendors, and contractors monthly to ensure compliance with federal and state regulations. Source

What is the List of Excluded Individuals and Entities (LEIE)?

The LEIE is a federal exclusion list maintained by the HHS/OIG that contains individuals and entities barred from participating in federal healthcare programs. Both mandatory and permissive exclusions are included, and states often add OIG exclusions to their own lists. Source

What types of exclusions are there and how long do they last?

Federal exclusions can be mandatory or permissive. Mandatory exclusions last a minimum of 5 years and typically involve felony convictions for healthcare fraud, drug offenses, or patient abuse. Permissive exclusions cover a wider range of conduct, often involving misdemeanors or licensing issues. Source

Are state exclusion lists different from federal lists?

Yes, 40 states maintain their own exclusion lists separate from the OIG’s LEIE. States may add OIG exclusions to their lists and adopt their own exclusion criteria. Sometimes, individuals appear only on state lists and not on the LEIE. Source

What is the payment prohibition for excluded persons?

Federal and state regulations prohibit payment for any item or service if an excluded individual contributed to it, directly or indirectly. Even indirect involvement, such as preparing a surgical tray or inputting information, can taint a claim. Source

How does the Affordable Care Act affect exclusion screening?

Section 6501 of the Affordable Care Act requires State Medicaid Agencies to terminate participation of any individual or entity terminated under Medicare or any other State Medicaid plan. This means exclusions in one program can trigger exclusions in others. Source

What are the federal and state screening requirements for providers?

Federal requirements, as outlined in the May 2013 Special Advisory Bulletin, require providers to check the LEIE for employees and contractors monthly. States may require screening of their own exclusion lists, the System for Award Management (SAM), and other state-specific lists. Source

Why is exclusion screening difficult for providers?

Screening is difficult due to manual entry limitations, large databases (LEIE contains nearly 60,000 names), and varying formats of state lists. Providers with many employees face logistical and technical challenges in meeting requirements. Source

Pricing & Plans

What does exclusion screening cost?

Exclusion Screening offers transparent pricing starting at /month for exclusion screening services. Pricing is competitive and tailored to the client’s needs, based on specific monitoring lists and volume of screenings. Source

How is the pricing for exclusion screening determined?

Pricing is determined by the specific lists that need to be monitored and the volume of screenings required. This ensures organizations only pay for what they need, making the service cost-effective and scalable. Source

How can I get a personalized quote for exclusion screening services?

You can fill out the form on the Exclusion Screening contact page to receive a personalized quote. The team will reach out to demonstrate the solution and discuss pricing details. Source

Features & Capabilities

What services does Exclusion Screening offer?

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

What is the SAFER™ software and how does it work?

The SAFER™ software automates exclusion screening, providing daily updates, advanced algorithms to handle inconsistent data formats and duplicate names, and scalability for organizations of all sizes. It reduces false positives and negatives and eliminates manual effort. Source

Does Exclusion Screening support vendor and contractor screening?

Yes, Exclusion Screening verifies vendors and contractors for compliance, ensuring compliant business relationships and reducing regulatory risks. This is critical for organizations with extensive vendor networks. Source

What is the compliance hotline and how does it help?

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

Does Exclusion Screening offer white label services?

Yes, Exclusion Screening offers white label services, allowing organizations to provide exclusion and sanction screening software under their own brand. Source

Use Cases & Benefits

Who can benefit from exclusion screening services?

Healthcare providers, including small practices, large healthcare systems, hospitals, clinics, and organizations with extensive vendor relationships, benefit from exclusion screening services. Roles such as compliance officers, risk managers, legal teams, and operational managers are primary users. Source

What business impact can customers expect from using exclusion screening?

Customers can expect improved compliance, cost savings, operational efficiency, risk mitigation, enhanced integrity, scalability, and legal and financial protection. Automation reduces manual effort and helps avoid penalties. Source

How quickly can exclusion screening be implemented?

New clients can get started and begin screening within 1 day, which is faster than many other vendors. The SAFER™ software is designed for seamless integration and easy setup. Source

Are there any case studies demonstrating the impact of exclusion screening?

Yes, Exclusion Screening provides a case study on OIG exclusions involving a Texas-based laboratory services company submitting false claims. The case highlights compliance challenges and the importance of thorough exclusion screening. Read the case study

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

The laboratory services industry is represented in Exclusion Screening's case studies. For more information on other industries, contact Exclusion Screening directly. Source

Pain Points & Problem Solving

What are the main pain points solved by exclusion screening?

Exclusion Screening addresses complexity of compliance, manual screening challenges, regulatory risks, fraud detection, cost-effectiveness, legal risks, and time/resource management. Automation and advanced algorithms reduce burdens and risks. Source

How does Exclusion Screening solve compliance complexity?

Exclusion Screening simplifies compliance by automating the process with SAFER™ software, eliminating the need for in-house management and ensuring accuracy with minimal effort. Source

How does Exclusion Screening address manual screening challenges?

Manual screening challenges such as inconsistent data formats, frequent updates, and duplicate names are resolved using advanced algorithms and daily updates in the SAFER™ software, reducing false positives and negatives. Source

How does Exclusion Screening help with regulatory risks?

Vendor and contractor screening services help organizations reduce regulatory risks by ensuring compliant business relationships and mitigating potential legal and financial repercussions. Source

How does Exclusion Screening support fraud detection and reporting?

The compliance hotline provides a secure and anonymous channel for reporting fraud, waste, and abuse, enabling early detection and resolution of compliance issues and fostering a culture of integrity. Source

Competition & Comparison

How does Exclusion Screening differ from other exclusion screening vendors?

Exclusion Screening stands out with its proprietary SAFER™ software, resolution-focused screening, expertise of former Federal prosecutors, comprehensive services, cost-effectiveness, scalability, and commitment to clients. Source

Why should a customer choose Exclusion Screening over alternatives?

Customers should choose Exclusion Screening for its advanced automation, resolution-focused screening, legal expertise, comprehensive offerings, competitive pricing, and time/resource efficiency. The company is developed by nationally recognized former Federal prosecutors. Source

What makes Exclusion Screening's approach unique?

Exclusion Screening approaches compliance as a legal risk, not just a data problem. It uses resolution-based screening, confirming identities with multiple data points, and provides thorough compliance checks without leaving investigative work to clients. Source

Product Information & Resources

Where can I find resources on the basics of exclusion screening?

You can access articles and guides on exclusion screening basics in the Exclusion Screening Basics category.

What is the vision and mission of Exclusion Screening?

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, mitigate legal risks, and support healthcare providers in focusing on their core operations. Source

Who founded Exclusion Screening and what is their expertise?

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

How can I contact Exclusion Screening for more information?

You can contact Exclusion Screening at (800) 561-0798 or fill out the contact form on their website for a free quote and assessment. Source

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Exclusion Screening Basics for Providers

Exclusion Screening Is Mandatory

Providers of medical services that participate in Federal or State Health Care Programs are required to screen all of their employees, vendors, and contractors monthly to ensure that none have been excluded from either the Medicare or Medicaid programs. Practices that fail to meet this requirement risk Civil Monetary Penalties (CMPs) and overpayments because Federal and State regulations prohibit payment for any item or service that was provided, directly or indirectly, by an excluded person.

Enforcement cases involving the employment of excluded persons are increasing dramatically. The imposition of CMPs more than doubled from 2013 to 2014, and recent case investigations have been supported by data analysis projects by the Office of Audit Services and the Office of Evaluation and Inspections. In light of the increasing enforcement efforts and the potential consequences, it is critical that providers gain a basic understanding of the issues relating to Exclusion Screening and how they can be addressed.

What is an Exclusion?

HHS/OIG has the authority (by delegation from the Secretary) to deny persons and entities the ability to participate in federal healthcare programs. When such an action is taken by the OIG, that person or entity is said to be “excluded” and placed on the List of Excluded Individuals and Entities (commonly abbreviated as “LEIE”).

Federal exclusions can be either mandatory or permissive, but both have the effect of barring participation in all federal healthcare programs until such time, if ever, that the government agrees to reinstatement. Mandatory exclusions last a minimum of 5 years and generally involve felony convictions for defrauding health care programs, felony drug offenses, and convictions for patient abuse or neglect. Permissive exclusions implicate a wider range of conduct and most often involve misdemeanor healthcare fraud, misdemeanor drug offenses, and licensing issues.

States also have the authority to exclude individuals and entities from participating in their own programs, such as Medicaid. Currently, 40 states maintain their own exclusion lists that are separate from the OIG’s LEIE. States will generally add OIG Exclusions to their own list, but they are also free to adopt their own exclusion criteria. It is important to note that states also often fail to report their own exclusions to CMS or the OIG such that it is not uncommon for an individual to end up on a state exclusion list and not the LEIE.

Federal and State Regulations Prohibit Payment for any Item or Service Performed by an Excluded Person

Neither Medicare nor Medicaid will pay for any item or service that results in a claim for reimbursement if an excluded individual contributed to it either directly or indirectly.  The so-called “payment prohibition” is broadly interpreted by the OIG. For instance, in its May 2013 “Special Advisory on the Effect of Exclusions,” they expressed the view that the preparation of a surgical tray or the inputting of information by an excluded person or vendor could taint a claim. Even volunteer work by an excluded person could trigger the prohibition unless the volunteer activities were “wholly unrelated to federal health care programs.”

Thus, a practice that hires an excluded person or does business with an excluded vendor or contractor could find that every billable service he or it contributes to is tainted. They would then be liable for a potential overpayment. Most states have also adopted this rationale and applied it to their Medicaid claims.

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Don’t Risk Civil Money Penalties, Overpayments, and Potential Actions under the False Claims Act

CMPs are often employed by the OIG as an enforcement tool when it discovers that claims have been made for an item or service that was provided, or contributed to, by an excluded employee. CMPs are very difficult to defend since the OIG has interpreted the relevant federal regulations to mean that the entity either “knew” of the exclusion and still submitted the claim, or that the entity “should have known,” but failed to properly screen the employee. Either way, penalties are appropriate, according to the OIG.

It should also be noted that Section 6501 of the Affordable Care Act (ACA) requires “State Medicaid Agencies to terminate the participation of any individual or entity if such individual or entity is terminated under Medicare or any other State Medicaid plan.” As such, any person terminated under any federal or state authority is subject to exclusion by all federal or state authorities. Therefore, their claims are potentially problematic.

The failure to screen also creates a risk for providers of being sued under the False Claims Act (FCA).  The theory behind FCA claims, which is employed with increasing frequency, asserts simply that since providers know that Medicare will not pay for a claim by an excluded person, a provider that fails to screen has constructive knowledge of the person’s status or is acting in deliberate ignorance.

Federal and State Screening Requirements

Federal screening requirements, as contained in the May 2013 Special Advisory Bulletin, require providers to check the LEIE for employees and contractors. According to the Bulletin’s guidance, providers should “review each job category or contractual relationship to determine whether the item or service being provided is directly or indirectly, in whole or in part, payable by a Federal health care program.” Then, providers should “screen everyone that perform[s] under that contract or in that job category” on a regular (read monthly) basis. If only it was that simple.

It is important to remember that the OIG’s guidance addresses only federal concerns. State Medicaid programs also have screening requirements that generally require, at a minimum, that providers screen their own State Exclusion List (37 States have them plus Washington, D.C.) in addition to the LEIE. Many also require screening of the System for Award Management list (SAM), and/or other State specific exclusions lists (such as sex offender lists, elder abuse lists, etc.). Furthermore, it is not uncommon for States to add onerous screening requirements in enrollment or re-enrollment applications and provider agreements. For example, a number of states require a certification that it has no employees that are suspended or excluded from any Federal or State Health Care Program. Some even require certification that their employees have never been excluded or suspended from any Federal or State exclusion list.

The Difficulty in Meeting Federal and State Exclusion Screening Requirements

Despite the OIG suggestions, the ability of individual practices to meet their federal screening requirements is difficult for a provider of any size. The current web-based LEIE interface allows only five employees to be screened at a time, each of which must be entered manually. Subsequently, potential matches must be verified individually by entering their Social Security Number. This might work for a provider who only has to screen a handful of employees or contractors. For a provider with a large number of employees, however, this would be a long and difficult undertaking.

The alternative OIG suggestion is to download the entire LEIE database and compare it to an employee list, but this is equally problematic – if not more so. The LEIE currently contains almost 60,000 names and few providers have the ability to compare that to their own employee database in any reliable or economically viable way.

Even if a provider has the ability to meet the OIG’s screening obligation, State exclusion lists must also be checked and they present additional problems. To start, State lists come in a variety of formats (Word, Excel, or PDF) with different data fields. Indeed, some State lists have little more than a name and an address. Furthermore, many states have additional state-specific screening requirements for lists. Finally, as previously indicated, practices need to be aware that a number of States have enrollment applications and provider agreements that require providers to certify that they have screened all employees and contractors with all federal and state exclusion lists.

Outsourcing is the Solution that makes Sense

In addition to the logistical problems associated with screening federal and state exclusion lists, there are practical concerns associated with ensuring compliance with a repetitive and difficult task that may be viewed as “unnecessary” by the person tasked with the job. The best solution all around is to find a vendor who will perform the task for you for a reasonable fee. This fee will probably be considerably less than the cost of doing the screening yourself.

A provider’s choice of a company price is an obvious concern, but there are other important factors to consider. For instance, a provider should ask: What is the company’s background in healthcare? Does it have an understanding of exclusion-related issues? Does it have a willingness and ability to assist the provider in determining vendor-related issues (such as who to screen and vendor certifications)? Will it provide support as needed? Does it have complimentary products such as hotline services that it can provide at little or no cost?

Conclusion

Exclusion Screening, LLC is one such vendor that is worthy of consideration. It’s co-founders, Robert Liles and Paul Weidenfeld, have both served as National Health Care Fraud Coordinators for the Department of Justice, and for the last several years they have both represented healthcare providers nationwide. They are healthcare lawyers who saw a problem that healthcare providers were having, and through Exclusion Screening, LLC they have created a simple and cost-effective solution. A provider need only put together a list of employees and vendors (with our assistance), and it does the rest for prices that are hard to believe.

Are you taking the necessary precautions to ensure you are not working with an excluded entity? We know it can be difficult to screen every Federal and State exclusion list. Call Exclusion Screening at (800) 561-0798 or fill out the form below to hear about our cost-effective solution and for a free quote and assessment of your needs.

Paul Weidenfeld is the author of this article. Contact Paul should you have any questions at: pweidenfeld@exclusionscreening.com or (800) 561-0798.

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