Can a Medicare Provider or Supplier Hire an Excluded Individual or Enter in a Contract with an Excluded Entity on the Medicare Exclusion List?

Medicare Exclusion List(October 9, 2019):  Should you choose to participate in the Medicare and / or Medicaid programs, you must comply with a wide variety of program integrity requirements. One obligation in particular is often missed by physician practices, home health agencies, hospices and laboratories – the “screening” of employees, contractors and agents to ensure that the provider or supplier has not employed or entered into a business relationship with an individual or entity that has been excluded from participation in Federal health care programs.[1]  Does that mean that a Medicare provider can never employ an excluded individual or entity? Such as someone on the Medicare Exclusion List?  Not necessarily.  In this article, we will examine how the Department of Health & Human Services (HHS), Office of Inspector General (OIG) has interpreted the impact and scope of an exclusion action.

I. How Did Medicare Exclusion List Screening Obligations Arise?

When reviewing mandatory exclusion screening obligations with health care providers and suppliers, we are regularly asked – How did this obligation arise?  As described below, as a participating provider in the Medicare and / or Medicaid program, you have been prohibited from employing (or contracting with) any individual or entity that has been excluded from participation in Federal health benefit programs for more than 40 years. A brief overview of the evolution of your statutory and regulatory exclusion screening obligation is set out below:
  • Medicare-Medicaid Anti-Fraud and Abuse Amendments. The statutory basis for the mandatory exclusion (from Medicare, Medicaid and other Federal health care programs) of physicians and other practitioners convicted of certain crimes was first enacted as part of the “Medicare-Medicaid Anti-Fraud and Abuse Amendments”[2]of 1977.  
  • Civil Monetary Penalties Law. The initial 1977 legislation discussed above was soon followed in 1981 by passage of the “Civil Monetary Penalties Law,”[3] which authorized the OIG to impose Civil Monetary Penalties (CMPs), assessments, and program exclusion actions against any party that submitted false, fraudulent or improper claims to Medicare or Medicaid for payment.
  • Medicare and Medicaid Patient and Program Protection Act.  In 1987, Congress passed legislation which expanded the OIG’s administrative authorities.  Section 1128(a) of the Act[4] outlined a number of adverse actions[5] which mandated the exclusion of an individual or entity from participation in Federal health care programs.  The agency’s expanded authorities included the establishment of additional mandatory and discretionary basis’ for excluding individuals or entities.  Finally, Section 214 set out the minimum period of exclusion that could be assessed against “practitioners and persons failing to meet statutory obligations.”
  • Health Insurance Portability and Accountability Act (HIPAA).[6]  Among its many landmark privacy and enforcement provisions, HIPAA also included statutory provisions related to the permissive exclusion of individuals and entities. For instance, under Section 212, the legislation established a minimum period of exclusion for certain individuals and entities subject to permissive exclusion from Medicare and State health care programs.  Additionally, Section 213 covers the permissive exclusion of individuals with ownership or a controlling interest in sanctioned entities.   
  • Balanced Budget Act (BBA of 1997).[7]  Under the BBA of 1997, Congress expanded the authorities under which an individual or entity could be excluded from participating in Medicare, Medicaid and other Federal health care programs. For instance, under Section 4301, individuals convicted of three or more health care related crimes became subject to permanent exclusion and pursuant to Section 4302, the Secretary could refuse to enter into Medicare agreements with individuals or entities convicted of felonies.  Finally, Section 4303 revised the Act to permit the Secretary of HHS (through the OIG), to exclude entities controlled by a family member of a sanctioned individual.  The BBA of 1997 also amended the CMPs that could be assessed against persons that contract with excluded individuals.
Medicare Exclusion List
  • Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs.[8]  This guidance was issued in an effort to help “affected parties better understand the scope of payment prohibitions that apply to items and services provided to Federal program beneficiaries, and to provide guidance to individuals and entities that have been excluded from the Federal health care programs and to those who employ or contract with an excluded individual or entity to provide such items or services.”
  • Medicare Prescription Drug, Improvement, and Modernization Act of 2003.[9]  Under 42 USC 1314, Section 949, the Secretary, HHS (after consulting with the OIG) was given the authority to waive the exclusion of an individual or entity if the “individual or entity is the sole community physician or sole source of essential specialized services in a community,” AND the party’s exclusion would impose a hardship on individuals entitled to benefits.
  • Solicitation of Information and Recommendations for Supplementing the Guidance Provided in the Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs. In November 2010, the OIG published a notice in the Federal Register, advising the public that it intended to update its 1999 guidance, “Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs,” and it sought comments from the public with respect to the development of the updated guidance.  As the request for comments noted:
“With time it has become even more apparent that exclusion has a significant impact, not only on those who have been excluded but also on entities that have employed or contracted with excluded persons and been faced with liability for overpayments and civil monetary penalties as a result. As OIG’s compliance and enforcement activities in this area have increased, many health care providers have discovered that they employ excluded individuals and have self-disclosed to the OIG.”[10]
  • Patient Protection and Affordable Care Act of 2010.[11] Under Section 6401, the Affordable Care Act imposed increased disclosure requirements on health care providers and supplier participating in the Medicare, Medicaid and / or CHIP programs.[12]  Among the new disclosure requirements was the fact that excluded “affiliations” now had to be disclosed to CMS. 
  • Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs (Special Advisory Bulletin).[13]  In May 2013, the OIG released an updated Special Advisory Bulletin addressing the effect of exclusion from participation in Federal health care programs. The updated 2013 guidance goes into considerable detail describing the scope and effect of an exclusion action items or services furnished (1) by an excluded person, or (2) at the medical direction or on the prescription of an excluded person.  The guidance also discusses the scope and frequency of a provider’s screening obligations.

II. What is the Practical Effect of Exclusion from Federal Health Care Programs:

Simply stated, an exclusion action is perhaps the most severe administrative remedy that can be imposed on an individual or entity by the OIG. If an individual is excluded by the OIG from participating in Medicare, Medicaid and other Federal health care programs, he or she cannot be hired or contracted to work for any entity that participates in any of these programs. From a practical standpoint, the government does not want any Federal health care monies to be used to pay any of the salary or benefits of an excluded individual.  This “payment prohibition” serves as complete ban and applies to “all methods of Federal program reimbursement” regardless of whether the reimbursement results from an itemized claim, an entry on a cost report or is included in a capitated payment to an entity.[14]  As the OIG’s 2013 Special Advisory Bulletin notes, the broad payment prohibition applied to excluded parties includes, but is not limited to the following:
  • Management, administrative or any leadership roles;
  • Surgical support or other activities that indirectly support care; 
  • Claims processing and information technology; 
  • Transportation services including ambulance company dispatchers;
  • Selling, delivering or refilling orders for medical devices; 
 
Notably, even the work of an unpaid volunteer who is an excluded party can trigger CMP liability if the services provided are not “wholly unrelated to Federal Health Care Programs.” [15]  In consideration of these broad prohibitions, you may ask “Can a Medicare provider ever hire an excluded individual”?  As discussed below, there are only four limited circumstances under which a participating provider can hire an excluded individual and avoid overpayment and CMP liability.  Moreover, it is very difficult to qualify for any of the exceptions that have been identified.

III. When Can a Medicare Provider or Supplier Employ an Excluded Individual?

Exception #1:  If Federal health care programs do not pay, either directly or indirectly, for any of the items or services being provided by the excluded individual, then a participating provider may employ or contract with an excluded person to provide those items or services.[16]    Unfortunately, this exception is far easier to describe than it is to appropriately arrange.  Two challenges immediately arise.  First, how will a participating provider be able to ensure that an excluded party will not be paid, either directly or indirectly, with reimbursement monies paid by Medicare, Medicaid and / or another Federal health benefits program? Second, how can a participating provider ensure that all of the items or services provided by an excluded individual “relate solely to non-Federal health benefit program patients?”  [17]

Exception #2:  If an employer employs or contracts with an excluded person to furnish items or services solely to non-Federal health care beneficiaries, a participating provider would not be subject to CMP liability.  As in the first example, this business arrangement is theoretically possible but would likely provide difficult to properly execute.  Prior to entering into this type of arrangement, we strongly recommend that the participating provide seek an Advisory Opinion from the OIG to verify that the duties, structure and payment practices would not trigger CMP liability.

Exception #3:  Seek an exclusion “Waiver” under Section 1128A(i)(5) of the Act. At the outset, it is important to note that an excluded individual does not have the authority to “request” a waiver of his or her exclusion action by the OIG.  If a mandatory exclusion action is based on violation of 42 CFR §1001.101(a), (c) or (d), the Administrator of a Federal health care program has the authority to request an exclusion waiver from the OIG.[18]  However, even the Federal health care Administrator does not the authority to seek an exclusion waiver if the exclusion action has been based on a conviction under Federal or State law of a criminal offense related to the neglect or abuse of a patient (as outlined under 42 CFR §1001.101(b)). 
In order to request an exclusion waiver from the OIG, the Administrator of a Federal health care program must first determine that:
“(1) The individual or entity is the sole community physician or the sole source of essential specialized services in a community; and
(2) The exclusion would impose a hardship on beneficiaries (as defined in section 1128A(i)(5) of the Act) of that program.”
If an exclusion action has been based on one of the OIG’s permissive exclusion authorities, the OIG can only grant a waiver of the exclusion action if the agency determines that imposition of the exclusion would not be in the public interest.[19] 

Exception #4:  Seek an Advisory Opinion from the OIG.  To the extent that you believe that a proposed arrangement which contemplates the employment of an excluded individual would not constitute grounds for the imposition of CMP sanctions, you may submit a request for an Advisory Opinion from the OIG.  From our review, it appears that there have only been three Advisory Opinion requests seeking guidance from the OIG on this issue since the issuance of the initial guidance in 1998.  Two of the Advisory Opinions involved the proposed employment of an excluded individual and the remaining Advisory Opinion examined whether a participating provider could purchase real estate that was owned and managed, in part, by an excluded individual.  The three Advisory Opinions examining the excluded party issue include:  
  • OIG Advisory Opinion No. 01-16: Issued September 2001 / Posted October 5, 2001.
  • OIG Advisory Opinion No. 03-01: Issued January 13, 2003 / Posted January 21, 2003.
  • OIG Advisory Opinion No. 19-05: Issued September 6, 2019 / Posted September 11, 2019.
Notably, the OIG held that none of the three proposed arrangements involving an excluded party would give rise to CMP sanctions. Before you jump to conclusions, however, we recommend that you read the specific factual scenarios involved in each of the requests for Advisory Opinion.  None of the proposed arrangements encompass situations that would be controversial or questionable in light of the financial and reimbursement relationship between the participating provider and the excluded individual.

IV. Recommendations for Medicare Providers Seeking to Employ an Excluded Party:

As a general rule, a Medicare provider cannot employ an excluded party. Yes, there are exceptions to this rule, but as described above, each of the primary exceptions discussed are quite narrow in scope and involve very fact specific scenarios where an excluded individual would not be providing services to Medicare beneficiaries and would not be paid, directly or indirectly from monies received in reimbursement from Medicare, Medicaid or Federal health care program claims.  It is important to keep in mind that only Exception #3 (Seeking a Waiver) and Exception #4 (Requesting an Advisory Opinion) offer any real opportunity to reduce the high level of risk that you will face if choose to employ an excluded individual or enter into a contract with an excluded entity. 

Exception #1 and Exception #2 are cited by the OIG in its 2013 Special Advisory Bulletin as possible factual scenarios where it may be possible to employ an excluded individual in a position that is sufficiently walled-off from the provision of services to Federal health care program beneficiaries, where no Federal funds are used to pay the individual’s salary, benefits, overhead and other costs. Unfortunately, even if such a position may initially be possible, over time there is a real possibility that the such barriers will erode.  Should this occur, your organization may face significant CMPs, possible False Claims Act penalties and damages, and other adverse administrative actions.  The bottom line is simple:

It is a Bad Idea to Try and Support the Employment of an Excluded Individual Based on the Reasoning Set out in Exception #1 and / or Exception #2.
 
Should you choose to proceed down this path, we strongly recommend that you contact experienced health law counsel (such as the folks at Liles Parker PLLC) for guidance and to determine if such as seeking a waiver or requesting an Advisory Opinion, a viable alternative with considerably less risk.

In the meantime, it is essential that you ensure that your employees, contractors, agents and vendors have not been excluded from participating in the Medicare, Medicaid or other Federal health care programs.  The folks at Exclusion Screening can help. Give us a call us at 1-800-294-0952 or fill out the form below to learn more about how we can help you!



[1] Now codified at Section 1128B(f) of the Social Security Act (the Act), the term “Federal health care program” means:
“(1) any plan or program that provides health benefits, whether directly, through insurance, or otherwise, which is funded directly, in whole or in part, by the United States Government (other than the health insurance program under chapter 89 of title 5, United States Code); or
(2) any State health care program, as defined in section 1128(h).”
[5] Generally, these mandatory exclusion actions included: (1) Conviction of Program-Related Crimes, and (2) Conviction Relating to Patient Abuse.  The legislation also covered a number of “permissive” exclusion actions.  These included:  (1) Conviction Related to Fraud; (2) Conviction Related to Obstruction of an Investigation; (3) Conviction Related to Controlled Substance; (4) License Revocation or Suspension; (5) Exclusion or Suspension Under Federal or State Health Care Program; (6) Claims for Excessive Charges or Unnecessary Services and Failure of Certain Organizations to Furnish Medically Necessary Services; (7) Fraud, Kickbacks and other Prohibited Practices; (8) Entities Controlled by a Sanctioned Individual; and (9) Failure to Disclose Required Information; (10) Failure to Supply Requested Information on Subcontractors of Suppliers; (11) Failure to Supply Payment Information; (12) Failure to Grant Immediate Access; (13) Failure to Take Corrective Action; and, (14) Default of Health Education Loan or Scholarship Obligations.
[6] Health Insurance Portability and Accountability Act of 1996, Public Law 104-191.  (August 21, 1996). 
[7] Balanced Budget Act (BBA) of 1997, Public Law 105–33.
[8] 64 FR 52791 (September 30, 1999).
[9] Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173.  (December 8, 2003).
[10] 74 FR 69452, 69453 (November 10, 2010).
[11] Patient Protection and Affordable Care Act of 2010, Public Law 111-148. June 9, 2010.
[12] For a more detailed discussion on these disclosure requirements, see the article outlining the Final Rule entitled “Medicare, Medicaid, and Children’s Health Insurance Programs; Program Integrity Enhancements to the Provider Enrollment Process.” 
[13] Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs.  Issued May 8, 2013.
[14] Ibid, at pgs. 6 and 7.
[15] Ibid, at pgs. 11 and 12.
[16] Ibid, at pg. 12.
[17] Id.
[18] 42 CFR 1001.1801(a).
[19] 42 CFR 1001.1801(c).

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

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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 (over 40 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

In 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.

Click below to learn more about the Exclusion Screening requirements in your State!
AlabamaIdahoMichiganNorth Carolina
AlaskaIllinoisMinnesotaNorth Dakota
ArizonaIndianaMississippiOhio
ArkansasIowaMissouriPennsylvania
CaliforniaKansasMontanaSouth Carolina
ColoradoKentuckyNebraskaTennessee
ConnecticutLouisianaNevadaTexas
FloridaMaineNew HampshireVermont
GeorgiaMarylandNew JerseyWashingtonWest Virginia
HawaiiMassachusettsNew YorkWashington DCWyoming
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 below. 



 

 

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?

What Medical Practices Need to Know About OIG Exclusion Screening

OIG Exclusion screening

By Paul Weidenfeld [1] The Office of Inspector General (OIG) has steadily increased its enforcement of OIG Exclusion Screening 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 Screening 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 OIG Exclusion Screening 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 OIG 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.

Want to know more about Exclusion Screening or need help with understanding your requirements? Fill out the form below!



 

OIG Exclusion screening 

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.