What Medical Practices Need to Know About an OIG Exclusion

OIG Exclusion

By Paul Weidenfeld [1] The Office of Inspector General (OIG) has steadily increased its enforcement of OIG Exclusion violations since the issuance of its Special Advisory stressing the effect of an OIG Exclusion in May, 2013. Among other things, they have created a special unit to focus specifically on  Civil Money Penalties (CMPs) (its favored enforcement tool), supported numerous prosecutions by both its Office of Audit and its Office of Evaluations and Inspections, and sought greater regulatory authority from Congress. This article was originally directed (and is still intended) to give a basic tutorial on what an exclusion is, how it effects them, and what they can do to protect themselves.

I.  What is an OIG Exclusion?

The Department of Health and Human Services (HHS) is responsible for administering the Medicare and Medicaid Programs and it decides who may receive benefits under these programs as well as who will be allowed to provide them. When it is determined that a person or entity will not be permitted to provide services to the program, that person or entity is said to be “excluded.” The authority to exclude individuals and entities from Federal health care programs has been delegated by the Secretary of HHS to the OIG.[2]

There are two types of OIG exclusions, mandatory and permissive, and both have the effect of barring an individual or entity from participating in all Federal health care programs until such time, if ever, that their privilege has been reinstated.[3]  Mandatory exclusions last a minimum of 5 years and must be imposed if a person or entity is convicted of certain criminal offenses. These include, among others, offenses related to defrauding Federal or State health care programs, felony convictions for other health care related offenses, most drug related felony convictions, and patient abuse or neglect.

Permissive exclusion authority implicates a much wider range of conduct. The type of conduct for which permissive exclusions may be imposed include misdemeanor convictions related to defrauding health care fraud programs; drug related misdemeanors; suspension, revocation or surrender of a health care license based on competence, performance, or financial integrity; providing unnecessary or substandard services; submitting false claims; defaulting on health education loans or student loans, and so on.

II.  What is the Impact of an OIG Exclusion?

The impact of an OIG exclusion extends to any provider who employs or contracts with the excluded person or entity. The regulation that grants OIG the exclusion authority states that payments cannot be made for items or services furnished “by an excluded individual or entity, or at the medical direction or on the prescription of a physician or other authorized individual who is excluded when the person furnishing such item or service knew or had reason to know of the exclusion.” 42 CFR § 1001.1901(b)

Though the language of the regulation appears to be directed at excluded persons who provide direct, billable services, the OIG broadly interprets the regulation to create a “payment prohibition” that includes virtually any item or service performed by an excluded person that contributes to any claim for reimbursement from any Federal or State Health Care Program.[4] For example, the OIG considers the preparation of a surgical tray or the inputting of information into a computer by an excluded person in violation of the prohibition. Similarly, administrative and management services, IT support, and even strategic planning would also be problematic. Even an excluded volunteer’s assistance might trigger the prohibition unless his activities were “wholly unrelated to Federal health care programs.”[5]

As indicated earlier, the favored enforcement tool is the imposition of civil penalties pursuant to 42 CFR §1003.102(a)(2). Though this regulation also appears to be restrictive in nature,[6]  the OIG interprets it to authorize CMPs for the failure of providers to screen their employees, vendors and contractors for exclusions. In its view, any time an “excluded person participates in any way in the furnishing of items or services that are payable by a Federal health care program,” [7] a  employer/provider that fails to screen will be held to have “known” — or “should have known” — of the exclusion.[8]

III.  OIG Exclusion Screening Requirements

Federal screening requirements are contained in the May, 2013 Special Advisory Bulletin.[9] The Advisory Bulletin states that in order for a provider to “avoid potential CMP liability,” they must check the List of Excluded Individuals and Entities (LEIE) to “determine the exclusion status” of their current employees, vendors and contractors. This can be done, according to the Bulletin’s guidance, by reviewing “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,” and then “screen everyone that perform[s] under that contract or in that job category.[10] 

While the OIG concedes that it does not have the authority to require that screening be performed every 30 days, it makes it clear that providers who fail to screen their employees, contractors, or vendors monthly risk the imposition of CMPs and overpayment liability. In addition, the OIG observes that the LEIE is updated on a monthly basis, that CMS mandated monthly screening for all State Medicaid Units in 2009 and 2011, and it requires monthly screening in all of its corporate integrity agreements.

IV. Are the OIG Exclusion Requirements Difficult to Meet?

The logistics of the screening process are extremely challenging for most providers despite the fact that the LEIE is a “searchable and downloadable database that can assist in identifying excluded employees.”[11]  Providers can elect to use the “search function” of the LEIE, but can only screen five employees at a time and each name must be entered manually. In addition, potential matches can only be verified individually by entering the social security number. This may work well if a provider only has to screen a handful of employees or contractors, but how would this work out if a provider has 200, 2,000, or even 20,000 employees?

The alternative, downloading the LEIE database and comparing the employee list to it, is equally problematic. Most providers simply do not have the capability to download the LEIE (which contains almost 60,000 names) and compare it with their own employee database in any reliable, or economically viable way. Another issue is the requirement that providers apply the same standard to contractors and sub-contractors as to their own employees. Contractors are unlikely to want to share their employee lists, and a provider would not want to screen the employee list of a large contractor. While the OIG does seem to recognize the issue by suggesting that providers can “choose to rely [on] screening conducted by the contractor,” it immediately follows the suggestion by reminding providers that they remain responsible for both overpayment liability and CMPs if they fail to ensure that “appropriate exclusion screening” has been conducted.[12]

V.  State Exclusion Requirements

It is important to remember that the OIG’s guidance addresses only federal concerns. While the OIG may be satisfied with just screening the LEIE on a  “regular” basis, there are only a handful of State Medicaid Programs that would find that this satisfied their requirements. Indeed, most States require, at a minimum, that providers screen their State Exclusion List (37 States have them) in addition to the LEIE, and many also require screening of the GSA/SAM[13] and/or other State specific exclusions lists (such as sex offender lists, elder abuse lists, etc.).

States also commonly include additional screening requirements through their provider agreements — some of which can be quite onerous. For example, in some States, applicants are required to certify that no employees or contractors are “suspended, or excluded from Medicare, Medicaid or other Health Care Program in any state”.[14] Additionally, State exclusion lists have a wide range of formats that vary from excel spreadsheets to unsearchable PDF documents further adding to the problems with screening.

For additional information refer to OIG Exclusion and State Exclusion Lists: Which Exclusion Lists Need to Be Screened? What Is the Difference Between Them?

VI.  Outsourcing of Exclusion Screening is a Simple, and Affordable Solution

Exclusion Screening, LLC was created because we recognized the difficulties providers faced when seeking to comply with their exclusion screening obligations.  We were determined to provide a simple, cost effective solution to the problem and we feel strongly that we accomplished our goal.  

Exclusion Screening is simple (we do all the work), cost effective (likely to cost less than the monthly cost of the water delivered to your office), and best of all, it is a complete solution to your screening needs. Call or email me if you have any questions at: pweidenfeld@exclusionscreening.com or 1-800-294-0952.

 

OIG Exclusion 

Paul Weidenfeld, Co-Founder and CEO of Exclusion Screening, LLC, is the author of this article. He is a longtime health care lawyer whose practice has focused on False Claims Act cases and health care fraud matters generally. 


[1] This is an update of an article that was first published in by the National Alliance of Medical Auditing Specialists (NAMAS) and posted on this website in November, 2014. It was done with the assistance of Jonathan Culpepper.

[2] Sections 1128 and 1156 of the Social Security Act. Though loosely defined to include any program that provides any health benefits, the most significant of these programs are Medicare and TRICARE. Medicaid exclusions are left to the State Fraud Control Units.

[3] Mandatory exclusions are found at 42 USC § 1320a-7; permissive exclusions at 42 USC § 1320a-7(b).

[4] The Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs issued May, 8, 2013 replaced and superseded the 1999 Bulletin and states: “This payment prohibition applies to all methods of Federal health care program payment, whether from itemized claims, cost reports, fee schedules, capitated payments, a prospective payment system or other bundled payment, or other payment system and applies even if the payment is made to a State agency or a person that is not excluded (at page 6 of the Bulletin).

[5] These are examples taken from the Special Advisory Bulletin, id.

[6] The regulation seems to be explaining the circumstances under which CMPs are available, not extending them stating that they may be assessed where a person making a claim stating: “knew, or should have known, that the claim was false or fraudulent, including a claim for any item or service furnished by an excluded individual employed by or otherwise under contract with that person.”

[7] Id. at 11.

[8] This is the language that appears in the OIG press releases announcing settlements of exclusion violations.

[9] Special Advisory Bulletin, at 13-18.

[10] Id. at 15-16.

[11] Id. at 14.

[12] Id. at 16.

[13] The System for Award Management (SAM) is the Official U.S. Government system that consolidated the capabilities of the CCR/FedReg, ORCA, and EPLS which were pre-existing debarment databases.

[14] See, for example, Rule § 352.5 of the Texas Administrative Code which specifically requires such a certification and the Louisiana Medicaid Provider Agreement.

Who Is to Blame for Gaps in OIG and State Exclusion Lists? What Is the Impact on Providers?

 

The failure to report excludable offenses by state Medicaid offices and licensing boards is a longstanding issue for the OIG. Recent OIG audits and reports have confirmed these state failures to report. For example, an OIG study released in August found that over 12% of terminated providers were able to continue participating in other state Medicaid programs because states were not sharing terminated provider information. In addition, two recent Medicaid Fraud Control Unit (MFCU) audits discovered that they routinely failed to timely report conviction information to the OIG and sometimes did not report them at all.[1] Reporting failures lead to gaps in the OIG Exclusion List (LEIE) because the OIG cannot exclude an individual if the OIG is never informed of the state’s conviction, termination, or suspension of providers. Such failures to report are important because the information that would have been reported can lead to exclusion violations, which are listed on the LEIE. But, state compliance failures are not the only cause of gaps in OIG and State exclusion lists – as we discuss, no matter who is at fault, the provider may pay for anyone’s mistake.

The OIG Exclusion List Has Limited Search Capabilities

One important reason providers should not rely on screening only the LEIE is that its search function is extremely narrow.  If an excluded individual uses a different name, such as a middle or maiden name, an LEIE search using the person’s first and last names my not produce any results.[2]  For example, J. A.[3] was excluded from participation on Georgia’s state exclusion list in August 2015. However, a search for “J.A.” on the LEIE currently produces zero results. 

J.A. LEIE_Redacted

Conversely, when we searched J.A. on SAFERTM, our proprietary exclusion database, we not only found a match on the Georgia list (“J.A.”), but we also found a match on the LEIE and SAM databases for “R.J.A.”. Interestingly, “J.A.” has the same middle and last name as “R.J.A.,” they are both Georgia residents, and they were both excluded from participation in April 2015. Like many states, the identifying information on Georgia’s list is sparse. Nevertheless, it is extremely likely that R.J.A. and J.A. are the same person, which a provider would have missed if he only searched the LEIE for J.A.

J.A.SAFER_Redacted

Reported Cases May Not Be Picked Up by OIG

Florida’s Agency for Health Care Administration publishes monthly press releases which identify persons terminated from participation in Florida Medicaid.  It expressly states that the exclusion information was “reported to the federal government for placement on the federal exclusion list,” and named providers appear on Florida’s Excluded Provider List.  When we conducted a SAFERTM search for G.B., who was listed on the April 2015 memo as “terminated from participation,” the only two “hits” were from Florida’s state exclusion list.  

G.B. SAFER_Redacted

However, an LEIE search for G.B. produced zero results.  

G.B. LEIE_Redacted

One possible explanation for why G.B. fails to show up on the LEIE could be the administrative process of OIG actually reviewing the reason for the termination and then formally excluding G.B. Nevertheless, a provider who only screens the LEIE and employs or is considering employing G.B. would miss this exclusion.  

OIG Just Misses Some Cases

K.B., a Registered Nurse (RN) with multistate licensure privileges, was placed on probation for substance abuse in February 2005. After testing positive for morphine, Iowa revoked her license and several other states revoked her multistate privileges. While the revocations were reported, the licensure revocation only resulted in K.B.’s exclusion from participation by California and the GSA-SAM in 2010. K.B. is not listed on the LEIE. This means that K.B. is unable to participate in any other state Medicaid program because under the ACA 6501, if you are terminated for cause from participation in one state, then you are terminated in all states, and K.B. is barred from contracting with the federal government. However, if a provider only screened the LEIE he would be completely unaware and could potentially face very hefty fines.

What This Means

Clearly some information is getting lost or mixed up in the reporting pipeline between state Medicaid offices, MFCUs, and the OIG, and the lesson for providers is that merely screening the LEIE is not enough. The examples above demonstrate that human error, narrow search functions, and simply missed information all play a role in the gaps that exist between publication on state exclusion lists and the LEIE.

State Medicaid offices are responsible for compiling and reporting information about excluded providers. However, as demonstrated by the “J.A.” case, the probable human error of transposing names combined with the LEIE’s limited search capabilities could result in a provider employing an excluded person, even though he was properly screened against the LEIE. To avoid this, providers should screen against the LEIE, the GSA-SAM, and all available state lists monthly. Practices should also ensure they use wide search parameters (alternate spellings, full names, maiden names, etc.) when conducting searches or they should select a vendor, like Exclusion Screening, LLC, with a system designed to anticipate these issues.

Notwithstanding name discrepancies, some information just does not make it to the LEIE. As the “G.B.” example reveals, a practice may face considerable monetary fines because it failed to screen the Florida exclusion list and relied solely on the LEIE for exclusion information, and the OIG failed to add G.B.’s name to the LEIE. Similarly, a provider who considered employing “K.B.” would be totally unaware that she was excluded from participation unless the provider screened the GSA-SAM and/or the California exclusion list. Remember that ACA section 6501 states that when an individual or contractor is excluded in one state, he or she is excluded in all states. When a provider misses such state exclusion information, he or she could be liable for CMPs of $10,000 for each claim provided directly or indirectly by the excluded individual, an assessment of up to three times the total amount paid by the government, and potential false claims liability.  Relying on the LEIE’s exclusion information without checking all other available state exclusion lists is a substantial monetary risk for a practice to take. If screening and verifying 40 state and federal exclusion lists each month is overly burdensome for your practice, contact Exclusion Screening, LLC today for a free assessment: 1 (800) 294-0952.

[1] MFCUs are supposed to send a referral letter to the OIG within 30 days of sentencing for the purpose of alerting the OIG about providers excluded from state programs, but the OIG found that in some cases this exclusion information was not referred to the OIG for over 100 days.

[2] We have even found that hyphenated names frustrate LEIE searches even where the actual names are used!

[3] Full names have been redacted for privacy.

Exclusion Screening Basics for Providers

Doctor in Medical Records room. Exclusion Screening Basics

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 “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 health care 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, 37 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 it’s 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 apply it to their Medicaid claims.

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, claims by them 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, requires 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 the 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. Please contact us to discuss your particular needs and get a free cost estimate today.

OIG Exclusion

Paul Weidenfeld is the author of this article. Contact Paul should you have any  questions at: pweidenfeld@exclusionscreening.com or 1-800-294-0952.

Medicare and Medicaid Exclusion Screening Compliance: A Challenging Problem with a Surprisingly Simple Solution©

exclusion

Since August 2014, the Office of Inspector General (OIG) has collected roughly $3.75 Million in Civil Money Penalties (CMPs) in cases involving the employment of persons that have been “excluded” from Medicare. This amount exceeds the total CMPs assessed by OIG on this issue in all of 2013. This continues an established trend. The number of exclusion cases has more than doubled over the last three years. The OIG specifically added exclusion violations to its Self Disclosure Protocol and followed that with new guidance on the issue within a matter of weeks last spring. Furthermore, even the Office of Audit Services has become involved with a data analysis project that supports enforcement efforts.[1] Considering this increasing interest, the failure to properly screen for excluded employees or contractors has become a real and tangible risk for providers that should not be ignored.

I.  What is An Exclusion?

The Department of Health and Human Services (HHS) is responsible for administering the Medicare and Medicaid Programs and it decides who may receive benefits under these programs as well as who will be allowed to provide them. When it is determined that a person or entity will not be permitted to provide services to the program, that person or entity is said to be “excluded.”

The authority to exclude individuals and entities from Federal health care programs has been delegated by the Secretary to the OIG.[2] There are two types of exclusions, mandatory and permissive, and both have the effect of barring an individual or entity from participating in all Federal health care programs until such time, if ever, that their privilege has been reinstated.[3] Mandatory exclusions last a minimum of 5 years and must be imposed if a person or entity is convicted of certain criminal offenses. These include, among others, offenses related to defrauding Federal or State health care programs, felony convictions for other health care related offenses, most drug related felony convictions, and patient abuse or neglect.

Permissive exclusion authority implicates a much wider range of conduct. Samples of the types of conduct for which permissive exclusions may be imposed include misdemeanor conviction related to defrauding heath care fraud programs; drug related misdemeanors; suspension, revocation or surrender of a health care license based on competence, performance, or financial integrity; providing unnecessary or substandard services; submitting false claims; defaulting on health education loans or student loans, and so on. 

II.  If I’m Not Excluded, How, or Why, Does it Affect Me?

Providers are affected because the impact of an exclusion extends to anyone who employs or contracts with the excluded person or entity. 42 CFR § 1001.1901(b) states that  payments cannot be made for items or services furnished “by an excluded individual or entity, or at the medical direction or on the prescription of a physician or other authorized individual who is excluded when the person furnishing such item or service knew or had reason to know of the exclusion.” Though the language of the regulation appears to be directed at excluded persons who provide direct, billable services, the OIG broadly interprets the regulation to create a “payment prohibition” that includes virtually any item or service performed by an excluded person that contributes to any claim for reimbursement from any Federal or State Health Care Program.[4] 

By way of example, in the OIG’s view the preparation of a surgical tray by an excluded person or the inputting of information into a computer by an excluded person could run afoul of the prohibition. Similarly, administrative and management services, IT support, and even strategic planning would also be problematic. Even an excluded volunteer’s assistance might trigger the prohibition unless his activities were “wholly unrelated to Federal health care programs.”[5]

In addition to overpayments that could result from the payment prohibition, providers can also be liable for CMPs pursuant to 42 CFR §1003.102(a)(2). Though this regulation, like § 1001.1901(b), seems intended to be restrictive in nature,[6] the OIG conflates it with the payment prohibition and broadly interprets it to authorize CMPs for any violation of the payment prohibition under circumstances where an “excluded person participates in any way in the furnishing of items or services that are payable by a Federal health care program”[7] and the provider “knew or should have known” of the exclusion.[8]

III.  What Are the Federal Exclusion Screening Requirements? Are they Difficult To Meet? Are There Separate State Requirements?

Federal screening requirements are contained in the May, 2013 Special Advisory Bulletin.[9] The Advisory Bulletin states that providers can “avoid potential CMP liability” simply by checking the OIG exclusion list, the List of Excluded Individuals and Entities (LEIE), to “determine the exclusion status of current employees and contractors”.[10] According to the Bulletin’s guidance, all providers have to do to meet this obligation is “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.”[11] Then providers must “screen everyone that perform[s] under that contract or in that job category”[12] on a “regular”[13] basis.[14] If only it was that simple.

To start, notwithstanding the fact that the LEIE is a “searchable and downloadable database that can assist in identifying excluded employees,”[15] the logistics of the screening process are extremely challenging. For instance, if a provider elects to use the “search function” of the LEIE, he can only screen five employees at a time and each name must be entered manually. In addition, potential matches can only be verified individually by entering the social security number. This might work well enough if a provider only has to screen a handful of employees or contractors, but how would this work out if a provider has 200, 2,000, or even 20,000 employees? The alternative of downloading the LEIE database is equally problematic.

Most providers simply do not have the capability to download the LEIE (which contains almost 60,000 names) and compare it with their own employee database in any reliable, or economically viable way. Another issue is the requirement that providers apply the same standard to contractors and sub-contractors as to their own employees. Contractors are not likely to want to share their employee lists. Neither would a provider want to screen the employee list of a large contractor. Thus, while the OIG does seem to recognize the issue by suggesting that providers can “choose to rely screening conducted by the contractor,” it immediately follows the suggestion by reminding providers that they remain responsible for both overpayment liability and CMPs if they fail to ensure that “appropriate exclusion screening” had been done.[16]

It is important to remember that the OIG’s guidance addresses only federal concerns. While the OIG may be satisfied with just screening the LEIE on a “regular” basis, there are only a handful of State Medicaid Programs that would find that this satisfied their requirements. Indeed, most States require, at a minimum, that providers screen their State Exclusion List (37 States have them) in addition to the LEIE, and many also require screening of the SAM[17] and/or other State specific exclusions lists (such as sex offender lists, elder abuse lists, etc.). 

Still, it is not uncommon for States to add onerous screening requirements through their provider agreements. For example, applicants have been required to certify that no employees or contractors are currently (or have ever been) “suspended, or excluded from Medicare, Medicaid or other Health Care Program in any state” (the emphasis is ours).[18] A final thought on the various State exclusions lists is that the lists have a wide range of formats that vary from excel spreadsheets to unsearchable PDF documents further adding to the problems with screening.

IV.  A Simple, Affordable Solution

Exclusion Screening, LLCSM was created because we saw a way to create a simple and cost effective solution to the challenges and risks that exclusion screening and verification requirements were causing our clients and many other practices and organizations. It is simple because once a provider puts together its list of employees and contractors (with our assistance) we do the rest. It is cost effective because Exclusion Screening, LLCSM charges are very small in comparison to the risk. Here’s how it works:

After the employee/contractor list is finalized, we screen it through SAFER™ (State And Federal Exclusion Registry), our proprietary exclusion registry comprised of the LEIE, SAM and all 37 State Exclusion Lists. SAFER™ also has a comprehensive search protocol that is far more inclusive than either the LEIE or SAM, so the screen will generate “potential matches” which are subjected to additional analytics to determine if there are any verified exclusions. Screens are conducted on a monthly basis and a report is sent to the provider that identifies each database that has been searched, the results of each search, all verified matches, and whether there are any outstanding potential matches (some State confirmation processes are more difficult and take longer than others). Interim reports are provided immediately after upon the verification of any match, and supplemental reports track all open potential matches until they are resolved.

V. Conclusion

Our process is simple, but we feel strongly that the monthly screening of all Federal and State Exclusion Lists will stand up to any level of scrutiny. In our experience, providers want to be in compliance and are willing to pay to ensure it, but they often experience frustration because the “compliance tools” they purchase are costly, time consuming, and difficult to implement. This will never be the case with Exclusion Screening, LLCSM. We not only do all the work once we have the list to be screened, but we also guarantee the provider’s satisfaction.

This article was written by Exclusion ScreeningSM co-founder, Paul Weidenfeld, and originally published within the National Alliance of Medical Auditing Specialists (NAMAS) “Medical Auditing Tip of the Week 12-12-2014″.

Paul Weidenfeld, Co-Founder and CEO of Exclusion Screening, LLC, is a longtime health care lawyer whose practice has focused on False Claims Act cases and health care fraud matters generally. Contact Paul should you have any  questions at: pweidenfeld@exclusionscreening.com or 1-800-294-0952.


[1] The project was identified last month in a press release announcing a CMP settlement for $357,341.96 with a chain of 74 long term care facilities. Seven excluded employees were found within the chain (less than 1 per 10 facilities), and the Office of Audit’s project was specifically credited for identifying 5 of the 7.

[2] See Sections 1128 and 1156 of the Social Security Act. Though loosely defined to include any program that provides any health benefits, the most significant of these programs are Medicare and TRICARE. Medicaid exclusions are left to the State Fraud Control Units.

[3] Mandatory exclusions are found at 42 USC § 1320a-7; permissive exclusions at 42 USC § 1320a-7(b).

[4] The Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs issued May, 8, 2013 replaced and superseded the 1999 Bulletin and states: “This payment prohibition applies to all methods of Federal health care program payment, whether from itemized claims, cost reports, fee schedules, capitated payments, a prospective payment system or other bundled payment, or other payment system and applies even if the payment is made to a State agency or a person that is not excluded, (at page 6 of the Bulletin).

[5] These are examples taken from the Special Advisory Bulletin, id.

[6] The regulation seems to be explaining the circumstances under which CMPs are available, not extending them stating that they may be assessed where a person making a claim stating: “knew, or should have known, that the claim was false or fraudulent, including a claim for any item or service furnished by an excluded individual employed by or otherwise under contract with that person.”

[7] Id., at 11.

[8] This is the language that appears in the OIG press releases announcing settlements of exclusion violations.

[9] Special Advisory Bulletin, at 13-18. It is noted, however, that this is a bulletin and not a formal regulation.

[10] Id., at 15.

[11] Id., at 15-16. The “same analysis” is used for contractors, subcontractors and employees.

[12] Id., at 16.

[13] Id., at 15 n.27.

[14] Id., at 16.

[15] Id., at 14.

[16] Id., at 16.

[17] The System for Award Management (SAM) is the Official U.S. Government system that consolidated the capabilities of the CCR/FedReg, ORCA, and EPLS which were pre-existing debarment databases.

[18] See, e.g., Rule § 352.5 of the Texas Administrative Code which states:

Prior to submitting an enrollment application, the applicant or re-enrolling provider must conduct an internal  review to confirm that  neither the applicant or the re-enrolling provider, nor any of its employees, owners, managing partners, or contractors (as applicable), have been excluded from participation in a program under Title XVIII, XIX, or XXI of the Social Security Act.

See also the Louisiana Medicaid Provider Agreement which requires applicants to certify that no employee is:

not now or … ever been: suspended or excluded from Medicare, Medicaid or other Health Care Program in any state” or “employed by a corporation, business, or professional association that is now or has ever been suspended or excluded from Medicare, Medicaid or other Health Care Programs in any state” (emphasis added).

Unlocking the GSA-SAM Mystery

server room GSA-SAM
I. GSA-SAM

We talk fairly infrequently about the General Service’s Administration’s System for Award Management (GSA-SAM) and thought it was time to address that lapse in information!

We know that the Office of the Inspector General has authority to exclude individuals under Section 1128 of the Social Security Act. It is also true that many individuals who appear on the SAM were originally listed on the Excluded Parties List System (EPLS). In addition, the SAM includes information from the Central Contractor Registration System (CCR) and the Online Representations and Certifications Application (ORCA). Now that these lists have merged, we wondered where the SAM was getting its updated exclusion information from.

II. The Agencies Reporting Exclusions to the GSA-SAM

If you have reviewed the SAM, you may have noticed that different agencies are listed along with excluded individuals. As of April 21, 2015, 68 federal agencies were reporting exclusions to SAM including the Department of Health and Human Services (HHS), the Department of Justice (DOJ), Veteran’s Affairs (VA), and the Department of Agriculture (USDA).

One of our favorite activities is getting into the weeds of an exclusion database, so our experts took a closer look at the agencies that were reporting to SAM. We discovered that over half of the total exclusions reported to SAM come from HHS. This was expected because we often find that if a name matches a person on the LEIE it also matches a person on the SAM. The next largest contributors were: the Office of Personnel Management (OPM) (26.6%); the Department of the Treasury Office of Foreign Assets Control (TREAS-OFAC) (6.2%); the Department of Justice (DOJ) (5.2%); and the Department of Agriculture Office of Food and Nutrition Services (USA-FNS) (3.1%).

Because OPM is the next largest reporting agency, we looked into who is excluded under its authority. OPM is also excludes health care providers. Specifically, it is debars them from participation in the Federal Employees Health Benefits Program (FEHBP). This means that 77.4% of the persons excluded on the SAM are excluded from participating from some health care industry component.

III.  Final Thoughts

This discovery supports our belief that it is critical to screen the SAM in addition to the LEIE.  OPM excludes from FEHBP individuals who have lost a professional license, been convicted of a crime related to the delivery of or payment for health care services, violated provisions of a Federal program, or been debarred by another Federal agency. These reasons mirror some of the reasons individual and entities are excluded from participation in the Federal health care programs by OIG and State Medicaid offices. It is likely that individuals excluded by OPM will also be excluded by the OIG, but there is no way to know how often information passes between these agencies or between licensing boards and the agencies. 

In our opinion, best practices include screening the SAM and the LEIE monthly, in addition to all available state lists, to ensure that your office is protected and potentially knows about an excluded individual before the OIG. Exclusion Screening, LLCSM conducts a comprehensive search of all available databases each month for its clients. For a free consultation, please call 1-800-294-0952 or fill out our assessment of needs and costs.

Ashley Hudson

Ashley Hudson, Associate Attorney at Liles Parker, LLP and former Chief Operating Officer for Exclusion Screening, LLC, is the author of this article. Contact the exclusion experts at Exclusion Screening, LLCSM today for a free consultation by calling 1-800-294-0952 or online.

Current States With Separate Exclusion Databases

Medicaid Exclusion

I. Medicaid Exclusion

Exclusion Screening, LLC conducts monthly checks of our clients’ employees, contractors, and vendors against the OIG-LEIE, GSA-SAM, and all available State Exclusion Lists. Most providers understand that they have an obligation to check their employees, contractors, and vendors against the OIG-LEIE prior to hiring and monthly thereafter. Fewer providers are aware of their obligation to screen their individual state exclusion list, if their state maintains such a list.

CMS directed state Medicaid Directors to remind all providers that they have an obligation to search their state list whenever they search the LEIE.[1] In addition, many states require providers when they enroll or re-enroll in the Medicaid program to certify that no employee or contractor is excluded from participation in any state. This requirement echoes the Affordable Care Act (ACA) Section 6501, which states that if a provider is excluded in one state, he or she is excluded in all fifty states.[2]

II.  SAFERTM 

Exclusion Screening, LLC’s proprietary database, SAFER (State and Federal Exclusion Registry), imports the most recent exclusion data from each state list constantly. We are also in regular contact with state Medicaid and Program Integrity Offices about their lists.

III. State Exclusion Lists

The states that currently maintain a separate excluded provider list are: 


IV.  Some States Require Screening Extraneous Lists

In addition to these states’ excluded provider lists, many states also require providers to check other various Medicaid Exclusion databases. In Ohio, for example, providers must search the Ohio Department of Developmental Disabilities Abuser Registry, the Ohio Auditor of State – Finding for Recovery Database, Ohio Department of Developmental Disabilities Abuser Registry, Social Security Administration’s Death Master File, The National Plan and Provider Enumeration System, in addition to the LEIE, SAM, and Ohio Exclusion List.[3] New Jersey providers must check the LEIE, New Jersey Division of Consumer Affairs licensure databases, New Jersey Department of Health and Senior Services licensure database, and the certified nurse aide and personal care assistant registry on a monthly basis.[4] 

For additional information visit “OIG Exclusion and State Exclusion Lists: Which Exclusion Lists Need to Be Screened? What Is the Difference Between Them?”
V.  A Simple and Affordable Solution

Without a doubt, state and federal exclusion screening requirements are incredibly burdensome for most providers. If screening your employees against each federal and state list that your state requires is not cost effective for your office to do in-house, contact Exclusion Screening, LLC today at 1-800-294-0952 or fill out our online service form. We would be happy to discuss your specific state obligations, provide a cost assessment, and help you create your employee and vendor list.

Medicaid oig Exclusion

Ashley Hudson, Associate Attorney at Liles Parker, LLP and former Chief Operating Officer for Exclusion Screening, LLC, is the author of this article.


[1] See Letter from Centers for Medicare and Medicaid Services (CMS) to State Medicaid Directors 5 (Jan. 16, 2009).

[2] See 42 U.S.C. § 1396a(a)(39) (2012), available at http://www.gpo.gov/fdsys/pkg/PLAW-111publ148/pdf/PLAW-111publ148.pdf (codifying the termination requirements of ACA § 6501); see also Letter from Centers for Medicare and Medicaid Services (CMS), CPI-CMS Informational Bulletin, Affordable Care Act Program Integrity Provisions – Guidance to States — Section 6501 – Termination of Provider Participation under Medicaid if Terminated under Medicare or other State Plan (Jan. 20, 2012), available at http://downloads.cms.gov/cmsgov/archived-downloads/CMCSBulletins/downloads/6501-Term.pdf.

[3] See Ohio Admin. Code § 5160-1-17.8(c)(ii); Ohio Medicaid Provider Exclusion and Suspension List, Ohio Dep’t of Medicaid, http://medicaid.ohio.gov/PROVIDERS/EnrollmentandSupport/ProviderExclusionandSuspensionList.aspx (last accessed Jan. 22, 2015).

[4] Newsletter to All Providers, from the New Jersey Dep’t of Human Servs., et al., Excluded, Unlicensed or Uncertified Individuals or Entities (Oct. 2010).

Why Should I Screen Against Every State Exclusion List?

man overwhelmed by paper - state exclusion list

The Office of the Inspector General (OIG) issued a Special Advisory Bulletin in May 2013, which states that providers can “avoid potential Civil Monetary Penalty (CMP) liability” simply by checking the List of Excluded Individuals and Entities (LEIE) to “determine the exclusion status of current employees and contractors.” This past fall, September – November 2014, OIG collected $1.54 Million in Civil Money Penalties (CMPs) in cases involving the employment of persons that have been “excluded” from Medicare.

These providers were held liable because they “knew or should have known” that an employee or contractor was excluded from participation in the Federal health care programs. The “knew or should have known” standard arises from the same 2013 OIG Special Advisory Bulletin. OIG states that because the LEIE is updated monthly, so OIG recommends that providers check their employees and vendors against the LEIE and SAM monthly in order to avoid CMP liability.  The CMPs a provider may face for employing or contracting with an excluded individual or entity include liabilities of $10,000 for each item or service furnished directly or indirectly by an excluded individual, in addition to an assessment of up to three times the total damages, and exclusion from participation in the Federal health care programs.

In addition to the federal lists, thirty-six states now have their own excluded provider lists.  These states require, at a minimum, that providers check their employees and contractors against their state list in addition to the LEIE as a requirement to participate in Medicaid and other state health care programs like SCHIP.  State mandates to search are hidden in a variety of documents such as Medicaid Provider Applications and Agreements, Disclosure of Ownership Interest, the State Code, or even the State’s Excluded Provider List.

At Exclusion Screening, LLCSM, we recommend screening your employees and contractors against not only the federal lists and your state’s list, but every available state list. The reason we recommend screening your employees against every available federal and state list is simple.  Do you want a person another state has determined is not permitted to bill to their Medicaid or SCHIP program working for your practice? A majority of individuals, at least according to the LEIE, are excluded because his or her license was revoked.  Other reasons include felony and misdemeanor convictions for committing health care fraud or for controlled substance offenses. 

As of December 2014, 26,178 individuals, or nearly half of the total individuals and entities excluded from participation in the Federal health care programs on the LEIE, were excluded due to a license revocation.  An immediate concern following this statistic is that, according to Deputy Inspector General for Investigations Gary Cantrell, not all state licensing boards provide information regarding adverse action taken against providers to OIG.  Cantrell reported to House Subcommittee on Oversight and Investigations within the Committee on Energy and Commerce, that States are not required to provide this information by statute leaving the OIG with incomplete exclusion information.

Furthermore, the under ACA Section 6501, all states are required to deny or terminate enrollment of any provider that is terminated “for cause” by Medicare or another State’s Medicaid or SCHIP program.  While the parameters of this new mandate are not yet flushed out, we believe that it is good practice to stay ahead of OIG when it comes to exclusions.  Under an ACA sister provision, 6401(b)(2), the Centers for Medicare and Medicaid Services (CMS) was required to create a national database where State agencies could share and access information about individuals and entities that were terminated from the Medicare, Medicaid, or SCHIP programs.  CMS created the Medicaid and Children’s Health Insurance Program State Information Sharing System (MCSIS) to make this information available to all State Medicaid agencies so that other states could identify providers that needed to be terminated.

Even though CMS had the authority to require states to submit this information, it only asked states to comply; CMS’s failure to make reporting mandatory resulted in a very deficient database with only 33 states submitting information, most of which was incomplete.  After two years of insufficient reporting, CMS discontinued the MCSIS database.  It plans to create a new private database, but CMS has not provided a proposed completion date for this new OnePI system or stated whether it would share information with the OIG-LEIE.

Additionally, some states have imposed their own strict requirements on providers.  Louisiana providers are required to check the LEIE, SAM, and the Louisiana Department of Health and Hospital Adverse Actions website upon hire and monthly thereafter for all employees and or subcontractors.  Louisiana providers are required to maintain proof in their records that these monthly checks were done for employees and or subcontractors, which may be evidenced by printing out search results. Providers are required to check all current and previous names  including first, middle, maiden, married, or hyphenated names and aliases for all owners, employees, and contractors.  If a provider learns an employee or subcontractor is excluded after hiring, the provider must notify the Department of Health and Hospitals within ten working days.

Texas, like Louisiana, requires that before a provider submits a Medicaid enrollment application, “the applicant or re-enrolling provider must conduct an internal review to confirm that neither the applicant or the re-enrolling provider, any of its employees, owners, managing partners, or contractors, have been excluded from participation” in Medicare, Medicaid, or SCHIP. In addition, Texas requires that an applicant or re-enrolling provider must also not be terminated from participation in another state’s medical assistance program or SCHIP. Texas Medicaid providers are responsible for checking the LEIE monthly and the Texas Medicaid Excluded Provider (HHSC) list upon hiring and periodically thereafter.  While Texas does not define periodically, it does remind providers that they are liable for all fees paid to them by Texas Medicaid for services provided by excluded individuals and “strongly recommend[] that providers conduct frequent period checks of the HHSC exclusion list.” The list is updated weekly.

Ohio also has a unique set of requirements.  Ohio Medicaid providers must, according to the Medicaid Provider Agreement, certify that he or she has no employment, consulting, or any other arrangement with excluded individuals or entities.  Managed Care Programs must, at a minimum on a monthly basis, search for excluded providers on the LEIE, the Ohio Department of Job and Family Services (ODJFS) Excluded Provider Page, and the applicable discipline pages of state boards that license providers.  Ohio providers are also required to search the SAM, the Ohio Department of Developmental Disabilities Abuser Registry, and the Ohio Auditor of State.

In addition to various state requirements, private health care companies also have begun including exclusion screening requirements.  Aetna, for example, requires that all health care professionals verify that all employees and “downstream entities that perform administrative or health care services to Aetna’s Medicare Plans” are not excluded on the LEIE or SAM.  If an Aetna provider discovers it has employed or contracted with an excluded provider, then he or she must immediately remove this individual or entity from Aetna related work and immediately notify Aetna.  Humana has nearly identical provisions for their physicians, hospitals, and other health care providers.

Screening employees for exclusions has morphed from an easy compliance responsibility to an overbearing obligation.  “Knew or should have known” is an easily manipulated standard.  Should you have known that another state excluded one of your employees or contractors? If OIG thinks so, you will be liable for Civil Monetary Penalties of up to $10,000 for each item or service furnished directly or indirectly by the excluded individual or entity, an assessment of up to three times the total damages, and exclusion from participation in the Federal health care programs. OIG has ramped up its exclusion enforcement evidenced by CMP liabilities resulting from self-disclosures and investigations totaling 6.07 million dollars in 2014 as compared to previous years with average CMP liabilities around $3 million.

The risks of not screening your employees against every state list significantly outweighs the costs of screening, especially when Exclusion Screening, LLCSM is able to efficiently and effectively screen your employees and vendors against all 38 lists at a very reasonable cost to providers.  Call 1-800-294-0952 today to discuss your exclusion screening needs and for a free assessment.

OIG Exclusion and State Exclusion Lists: Which Exclusion Lists Need to Be Screened? What Is the Difference Between Them?

oig exclusion list

There are two federal databases that list persons and entities that have been excluded from participating in federal health care programs or receiving federal contracts. Checking and verifying individuals on the OIG Exclusion List of Excluded Individuals and Entities (LEIE) and the GSA System for Award Management (SAM) should be part of any compliance exclusion screening program. The LEIE is maintained and updated by the Office of Inspector General for the Department of Health and Human Services (HHS-OIG), and the SAM consolidates several procurement based databases. 

Many states (37 as of today) also have their own individual databases which list individuals and entities that have been excluded from participating in their State Programs (such as Medicaid) or receiving any State contracts. We’ll briefly discuss the difference between these exclusion lists and explain why each should be screened. 

I.  OIG Exclusion List (LEIE)

oig exclusion list

The OIG exclusion list, LEIE, is maintained specifically for the purpose of listing all persons and entities that have been excluded from participating in the Medicare program. It is comprised of all persons currently excluded from the program by the OIG and is updated monthly. The list contains the name of the excluded individual or entity at the time of the exclusion, the provider type, the authority under which the individual was excluded, and the state where the excluded individual resided at the time of the exclusion. The LEIE can be accessed on the OIG’s website and up to five names can be searched at a time. It can also be downloaded for searching purposes. Matches can then be verified individually by Social Security Number.

It is important to remember that the LEIE is prepared and maintained by HHS for the specific purpose of identifying persons or entities that have been excluded from the Medicare Program by its Inspector General. Therefore, it will not contain persons or entities on other exclusion lists if, for instance, the information was never forwarded to it, or if the basis of that exclusion was insufficient to support one from the LEIE.[1]

II.  GSA-SAM

oig exclusion list

The SAM is an attempt by the federal government to consolidate several pre-existing procurement systems and combine them with the Catalog of Federal Domestic assistance. It is being done in phases. The first phase combined the functionality of the systems that listed persons or entities that were debarred, sanctioned, or excluded for contract or other fraud into a single searchable exclusion database. These were the Central Contractor Registry (CCR), Federal Agency Registration (FedReg), Online Representations and Certifications Application (ORCA), and the Excluded Parties List System (EPLS).

The SAM uses four exclusion classifications: Firm, Individual, Vessel, and Special Entity Designation. It also uses four exclusion types: Ineligible (Proceedings Pending), Ineligible (Proceedings Completed), Prohibition/Restriction, and Voluntary Exclusion.[2] There is significant overlap between the SAM and the LEIE. However, they were both created by several different agencies, and each has its own specific administrative process. It is not surprising that there are large gaps between them, and that they are ultimately very different in composition.

III.  State Medicaid Exclusion Lists

oig exclusionIn addition to the HHS OIG Exclusion List of Excluded Individuals and Entities ( LEIE ) and the GSA SAM, several states (plus the District of Columbia) have their own Medicaid Exclusion Lists. These states are identified in red in the map to the left. In addition to being excluded from the specific states in which a person or entity is listed, Section 6501 of the Affordable Care Act (ACA) mandates that if a provider or entity is excluded under any state Medicaid database, then that provider or entity should be excluded from participating in all states.[3] State lists typically contain exclusions based upon licensing issues and many of these exclusions are not found on the LEIE, SAM or other state Lists. This occasionally occurs because the exclusion is based on a violation of a particular state statute. It also occurs because many states have inadequate processes to communicate exclusions to either the Federal Databases or their sister states.

IV. Conclusion

The OIG exclusion list LEIE, (GSA) SAM, and State Medicaid databases were all created by different entities for different reasons. They have different exclusion criteria and though they address concerns that may be similar in nature, the information is often agency specific. Ultimately, the lists often contain different entities and persons. Considering these differences and the severity of the risk of employing excluded persons, we strongly recommend conducting monthly searches of all of these databases. Contact the exclusion experts at Exclusion Screening, LLCSM by calling 1-800-294-0952 or fill out our online service form.

Ashley Hudson

Ashley Hudson, Associate Attorney at Liles Parker, LLP and former Chief Operating Officer for Exclusion Screening, LLC, is the author of this article. 


[1] For more information see other discussions within our site on the effects of exclusion and the publication by the U.S. Dep’t of Health and Human Servs. Office of the Inspector Gen., Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs, 13 (May 8, 2013).

[2] When EPLS was consolidated into SAM in July 2012 Cause and Treatment (CT) codes were eliminated. For more information on the transformation see Changes from EPLS to SAM on the SAM website at https://www.sam.gov/sam/transcript/Quick_Guide_for_Changes_From_EPLS.pdf.

[3] 42 U.S.C. 1396(a) (2012). Whether an exclusion by one state actually “excludes” an individual from all states or makes him “excludable” from all states is an open question at present, but why take the chance of hiring a person who has been excluded in another State if you don’t have to?

Prevention of Grant Awards to Excluded Persons and Entities added to OIG 2015 Work Plan

OIG Work Plan 

I. 2015 OIG Work Plan

The Office of Inspector General’s (OIG) ongoing concern regarding exclusion enforcement is reflected in its 2015 OIG Work Plan. In the work plan, the OIG announced that its Office of Audit Services will study whether the operating divisions within its own agency have been taking adequate precautions to ensure that excluded or debarred individuals and entities are not being awarded Federal grants or contracts.[1] Noting that “[f]ederal agencies are required to make awards only to responsible sources,” the work plan states that precluding firms or individuals that have been excluded or suspended from receiving contracts or assistance is one of the ways of achieving that objective. The work plan suggests that it is following up on a GAO Report that “found that some agency programs need greater attention, and government wide oversight could be improved.”

Interestingly, the study is focused exclusively on suspensions and debarments reported in the System for Award Management (SAM), the exclusion database maintained by the General Services Administration. While this might signify that the OIG is satisfied with agency enforcement of its own administrative sanctions, the important takeaway is that the OIG is holding its own agency to a standard that includes screening the SAM in addition to the LEIE.  It will be very interesting to see what the U.S. Department of Health and Human Services (HHS) does.

II. Conclusion

The results of this study in the work plan provides two important messages. First, it serves to remind that screening the LEIE alone is not enough. Second, it reminds us that the enforcement of the payment prohibition to excluded persons and entities remains a high enforcement priority for the OIG.

OIG Work Plan

Paul Weidenfeld, Co-Founder and CEO of Exclusion Screening, LLC, is the author of this article. He is a longtime health care lawyer whose practice has focused on False Claims Act cases and health care fraud matters generally. Contact Paul should you have any  questions at:  pweidenfeld@exclusionscreening.com or 1-800-294-0952.


 [1] OAS; W-00-15-59024  is expected to be issued in FY 2015.

Alert to Florida Providers Regarding Screening

 I.  Florida’s State Exclusion. Excluded Providers Costs OIG Over 2.7 Million

The Office of the Inspector General (OIG) recently released a study on a subset of Florida’s Medicaid payments for pharmaceutical items. The study showed that in 2009 and 2010 the State agency made $180,000 in payments for pharmaceutical items prescribed by excluded providers. OIG, comparing this number to the total number of pharmacy payments, concluded that the State agency may have paid up to $2.7 million for items that excluded providers had prescribed.[1]

OIG concluded that these over-payments occurred because the State agency did not have proper policies in place to conduct prepayment review. Specifically, the agency had not established sufficient prepayment controls to ensure that valid provider IDs were on every pharmacy claim, and that the prescribing provider identification numbers were valid before making payments.

II.  Monthly Exclusion Screening Is Essential to Maintaining Effective Compliance Programs

Furthermore, the State agency was only conducting periodic searches of the LEIE and the GSA-SAM, which are maintained by OIG and CMS, respectively. This serves as just another reminder to providers that exclusion searches, in order to be effective, must be conducted monthly and must include searches of the LEIE, the GSA-SAM, and all 37 state Medicaid lists. Failure to search every list creates a hole in your screening process and allows excluded individuals to continue billing to the Federal health care programs.

Florida has since created its own suspended provider list like a majority of the states. In addition to building this new system, it also refunded the Federal health care programs in the amount of $99,568. That expense could have been avoided with thorough monthly exclusion checks.

III. Conclusion

All providers must conduct monthly exclusion screening on the LEIE, GSA-SAM, and all 37 state Medicaid lists. OIG is aggressively cracking down on providers who employ excluded individuals and will impose Civil Monetary Penalties (CMPs) of up to $10,000 for each item or service billed to the Federal health care programs that was provided directly or indirectly by an excluded individual.

Read more on State Exclusion 

Florida's State Exclusion 

Ashley Hudson, 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] Lori S. Pilcher, Florida Made Some Payments for Pharmacy Items That Excluded Providers Had Prescribed, Dep’t of Health and Human Servs., Office of the Ins. Gen., 3 (June 2014).

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