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

Hiring Federally Excluded Individuals(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?  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 Your Exclusion 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.
Hiring Excluded Individuals
  • 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 #1If 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 #2If 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 #3Seek 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 at:  1 (800) 294-0952.



[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?

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 HampshireWashington
GeorgiaMarylandNew JerseyWashington DC
HawaiiMassachusettsNew YorkWest VirginiaWyoming
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?

What Medical Practices Need to Know About OIG Exclusion Screening

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.

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

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

Neither Medicare nor Medicaid will pay for any item or service that results in a claim for reimbursement if an excluded individual contributed to it either directly or indirectly.  The so-called “payment prohibition” is broadly interpreted by the OIG. For instance, in 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.

HHS/OIG Excludes Illinois Home Health Agency for Exclusion Violation!

hhs/oig
Home Health Agency Excluded for Employing Excluded Nurse

HHS/OIG recently issued a press release announcing that it had excluded an Illinois home health agency participation in all Federal health programs as a result of its employment of an excluded nurse. OIG’s investigation revealed that the home care service had billed the Federal health care programs for services provided by the excluded nurse to both Medicare and Medicaid beneficiaries.

An Unprecedented Move by HHS/OIG

As far as we can tell, this is the first time that this has been the basis of an exclusion, and it further evidences the ongoing enforcement interest that the OIG has in exclusion violations. The exclusion became effective March 19, 2015, and participation in Federal health care programs for a period of three years. It is also worthy of note that the OIG staffed the case with two Senior Counsels and a Paralegal Specialist, Eula Taylor.

If your practice doesn’t screen for exclusions, give the experts at Exclusion Screening, LLCSM a call at 1-800-294-0952 or fill out our assessment of needs and costs.

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.

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).

Hospital Enters into False Claims Settlement for Employee with Lapsed License

false claims
I.  Hospital Employed Therapist with Lapsed License

The Department of Justice (DOJ) entered into a settlement with a nonprofit Michigan hospital this week resolving allegations that the hospital submitted false Medicaid claims. The services had allegedly been rendered by a therapist with a lapsed license. Further, in an unusual move, DOJ required the hospital to acknowledge in the false claims settlement that it should have known of the lapsed license when it submitted the claims.

II.  No Difference Between a Lapsed License and an Exclusion for False Claims Liability

This case is of particular interest because when analyzing the potential for False Claims Act liability, there is no appreciable difference between a person with a lapsed license and a person that has been excluded from Medicare or Medicaid. That is, the claims are said to be legally “false” because of the individual’s status (having no license and being excluded). Unless an employer can come up with a satisfactory explanation (in the eyes of DOJ or HHS/OIG) why he or she wasn’t aware, that employer will either be presumed to have “known” of the status or it can be determined that he or she “should have known” of it. Of course, in either event, liability can attach!

So, beware and be sure to screen your employees, vendors and contractors as required!

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. Contact Paul should you have any  questions at: pweidenfeld@exclusionscreening.com or 1-800-294-0952.

OIG Trumpets Exclusions, New Actions and Recoveries in its Semi-Annual Report to Congress

OIG report
I.  OIG Report

In the Office of the Inspector General’s (OIG) semiannual report to Congress, it claimed credit for excluding 2,297 individuals and entities from Medicare, Medicaid, and other Federal health care programs. The OIG also claimed credit for initiating 506 criminal and 267 civil actions. According to the OIG report, most of the exclusions resulted from convictions for crimes relating to Medicare or Medicaid, patient abuse or neglect, or license revocations. The civil and criminal actions were primarily initiated against “individuals or entities engaged in health-care related offenses.” In addition, the OIG told Congress that it was responsible for generating $1.26 billion in investigative receivables due to the Department of Health and Human Services.[1]

II.  Failure to Screen

The OIG also identified some of the cases that were felt to be important. Two of these cases involved exclusion related issues. In one case, the OIG imposed $15,000 in penalties against a company under a corporate integrity agreement for failing to timely screen employees and other “covered persons.” This is of particular interest to us because the penalty was not imposed for having an excluded employee. Instead, the penalty was imposed for failing to screen! This, again, demonstrates the interest and concerns of the OIG in exclusion issues.

III.  Mandatory Exclusion 

In the other case, a physician who had been excluded due to a conviction for a health care related offense, arranged an elaborate scheme to hide his involvement in a dermatology practice so that it could bill Medicare and Medicaid for services despite his excluded status. His scheme was eventually discovered, and he was tried by a jury. He was then convicted of health care fraud, bankruptcy fraud, identity theft, and the filing of false tax returns. Ultimately, he was sentenced to 8 years and 3 months of incarceration, ordered to pay $265,330 in restitution, and fined $2.6 million. 

IV.  Permissive Exclusion

Finally, the OIG report also states that the OIG continues to enforce the HEAL (Health Education Assistance Loan) Program. It further states that 20 individuals entered into settlement agreements, and $1.5 million was collected during the reporting period. We bring this up as a reminder that vigilance in this area is a necessity! There are any number of different ways for individuals and entities to be excluded from Medicare and Medicaid. Let the experts at Exclusion ScreeningSM help ensure your organization does not employ an excluded individual or entity. Contact us for a free consultation at 1-800-294-0952 or fill out our online service form.

OIG Exclusion

Paul Weidenfeld, Co-Founder and CEO of Exclusion Screening, LLC, is the author of this article.


[1] U.S. Dept. of Health & Human Services Office of Inspector General Semiannual Report to Congress, at 26.

How to Apply for Reinstatement

OIG Exclusion Reinstatement

I. The OIG Exclusion Reinstatement Process

Most exclusions are imposed for a definite time period. The question for an excluded individual or entity is: What happens at the end of the exclusion period?

   The answer is that the excluded individual or entity must apply for reinstatement. The U.S. Department of Health and Human Services (HHS) will NOT automatically reinstate the person or entity at the end of the exclusion period.

An excluded provider may apply for reinstatement 90 days before the date specified on his, her, or its exclusion notice letter. To apply for reinstatement the excluded individual or entity must send a written request to:

HHS, OIG, OI
Attn: Exclusions
P.O. Box 23871
Washington, DC 20026
(202) 691-2298 (Fax)

  The Office of the Inspector General (OIG) will send the provider Statement and Authorization forms to complete, notarize, and return. OIG will review these forms and will send the provider a written notification of its final decision. This process may take 120 days or longer to complete.

II. Denial of OIG Exclusion Reinstatement

If the application for reinstatement is denied, the excluded individual or entity may submit evidence and a written argument against the continued exclusion; a written request to present written evidence and oral argument to an OIG official; or documentary evidence and a written request to present oral argument.[1] The evidence, written argument, or written request for a hearing must be submitted 30 days after the provider receives the written notice of OIG’s final decision.[2]

After reviewing the materials (or after the 30-day period, if no materials are submitted), OIG will send the provider written notice either confirming the denial or approving the request for reinstatement.[3] If OIG confirms its decision to deny reinstatement, the decision will not be subject to administrative or judicial review and the provider must wait at least one year to submit another request for reinstatement.[4]

Read more on OIG Exclusion 

 OIG Exclusion Reinstatement 

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] 42 C.F.R. 1001.3004 (2014).

[2] 42 C.F.R. 1001.3004.

[3] 42 C.F.R. 1001.3004.

[4] 42 C.F.R. 1001.3004.