OIG Screening Requirements
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US Department of Health and Human Service Office
of Inspector General
The OIG has the authority to exclude individuals and
entities from Federally-funded health care programs pursuant to
sections 1128 and 1156 of the Social Security
Act and maintains a list of all currently excluded
individuals and entities called the List of Excluded Individuals
and Entities (LEIE). Anyone who hires an individual
or entity on the LEIE may be subject to civil monetary penalties
(CMP).
To avoid CMP liability, health care entities need
to routinely
check the LEIE to ensure that new hires and current
employees are not on the excluded list.
The effects of an exclusion are outlined in the Special
Advisory Bulletin on the Effect of an Exclusion, but the
primary effect is that no payment will be provided for any items or
services furnished, ordered or prescribed by an excluded individual
or entity. This includes Medicare, Medicaid and all other federal
plans and programs that provide health benefits funded directly or
indirectly by the United States (other than the Federal Employees
Health Benefits Plan).
You may access additional information on the
website links below and/or please contact your corporate counsel to
ensure that you have the appropriate systems and processes in place
for compliance.
Online Searchable Database: http://exclusions.oig.hhs.gov
LEIE Downloadable Databases: http://oig.hhs.gov/exclusions/exclusions_list.asp
Quick Tips: http://oig.hhs.gov/exclusions/tips.asp
Exclusions Authorities: http://oig.hhs.gov/exclusions/authorities.asp
Monthly Supplement Archive: http://oig.hhs.gov/exclusions/supplement_archive.asp
Applying for Reinstatement: http://oig.hhs.gov/exclusions/reinstatement.asp
Contact the Exclusions Program: http://oig.hhs.gov/contact-us/index.asp#exclusions
Frequently Asked Questions: http://oig.hhs.gov/faqs/exclusions-faq.asp
Special Advisory Bulletin:
http://oig.hhs.gov/faqs/student-diversity-volunteer-internship-program-faq.asp
The following information is from US Department of
Health and Human Service Office of Inspector General (http://www.oig.hhs.gov/exclusions/index.asp):
The OIG has the authority to exclude individuals and entities from
Federally-funded health care programs pursuant to
sections 1128 and 1156 of the Social Security
Act and maintains
a list of all currently excluded individuals and entities called
the List of Excluded Individuals and Entities (LEIE). Anyone who
hires an individual or entity on the LEIE may be subject to civil
monetary penalties (CMP). Exclusions are imposed for a number of
reasons: Mandatory exclusions: OIG is required by law to
exclude from participation in all Federal health care
programs individuals and entities convicted of the following
types of criminal offenses: (1) Medicare or Medicaid fraud, as well
as any other offenses related to the delivery of items or services
under Medicare, Medicaid, SCHIP, or other State health care
programs; (2) patient abuse or neglect; (3) felony convictions for
other health care-related fraud, theft, or other financial
misconduct; and (4) felony convictions relating to unlawful
manufacture, distribution, prescription, or dispensing of
controlled substances. Permissive exclusions: OIG has discretion to
exclude individuals and entities on a number of grounds, including
misdemeanor convictions related to health care fraud other than
Medicare or a State health program, fraud in a program (other than
a health care program) funded by any Federal, State or local
government agency; misdemeanor convictions relating to the unlawful
manufacture, distribution, prescription, or dispensing of
controlled substances; suspension, revocation, or surrender of a
license to provide health care for reasons bearing on professional
competence, professional performance, or financial integrity;
provision of unnecessary or substandard services; submission of
false or fraudulent claims to a Federal health care program;
engaging in unlawful kickback arrangements; and defaulting on
health education loan or scholarship obligations; and controlling a
sanctioned entity as an owner, officer, or managing employee. To
avoid CMP liability, health care entities need to routinely check
the LEIE to ensure that new hires and current employees are not on
the excluded list. The effects of an exclusion are outlined in the
Special Advisory Bulletin on the Effect of an Exclusion, but
the primary effect is that no payment will be provided for any
items or services furnished, ordered or prescribed by an excluded
individual or entity. This includes Medicare, Medicaid and all
other federal plans and programs that provide health benefits
funded directly or indirectly by the United States (other than the
Federal Employees Health Benefits Plan). OIG's exclusions process
is governed by regulations that implement sections of the Social
Security Act. When an individual or entity gets a Notice of Intent
to Exclude, it does not necessarily mean that they will be
excluded. OIG will carefully consider all material provided
by the person who received the Notice as we make our decision. All
exclusions implemented by OIG may be appealed to an HHS
Administrative Law Judge (ALJ), and any adverse decision may be
appealed to the HHS Departmental Appeals Board (DAB). Judicial
review in Federal court is also available after a final decision by
the DAB.
The Effect of Exclusion From
Participation in Federal Health Care
Programs
September 1999
A. Introduction
The Office of Inspector General (OIG) was established in the U.S.
Department of Health and Human Services to identify and eliminate
fraud, waste, and abuse in the Department's programs and to promote
efficiency and economy in Departmental operations. The OIG carries
out this mission through a nationwide program of audits,
inspections, and investigations. In addition, the OIG has been
given the authority to exclude from participation in Medicare,
Medicaid and other Federal health care programs(1) individuals and entities who
have engaged in fraud or abuse, and to impose civil money penalties
(CMPs) for certain misconduct related to Federal health care
programs (sections 1128 and 1128A of the Social Security Act (the
Act)). Recent statutory enactments have strengthened and expanded
the OIG's authority to exclude individuals and entities from the
Federal health care programs. These laws also expanded the OIG's
authority to assess CMPs against individuals and entities that
violate the law. With this expanded authority, the OIG believes
that it is important to explain the effect of program exclusions
under the current statutory and regulatory provisions. The Health
Insurance Portability and Accountability Act (HIPAA) of 1996,
Public Law 104-191, authorized the OIG to provide guidance to the
health care industry to prevent fraud and abuse, and to promote
high levels of ethical and lawful conduct. To further these goals,
the OIG issues Special Advisory Bulletins about industry practices
or arrangements that potentially implicate the fraud and abuse
authorities subject to enforcement by the OIG. In order to assist
all affected parties in understanding the breadth of the payment
prohibitions that apply to items and services provided to Federal
program beneficiaries,(2) this Special Advisory Bulletin
provides guidance to individuals and entities that have been
excluded from Federal health care programs, as well as to those who
might employ or contract with an excluded individual or entity to
provide items or services reimbursed by a Federal health care
program. B. Statutory Background In 1977, in the
Medicare-Medicaid Anti-Fraud and Abuse Amendments, Public Law
95-142, Congress first mandated the exclusion of physicians and
other practitioners convicted of program-related crimes from
participation in Medicare and Medicaid (now codified at section
1128 of the Act). This was followed in 1981 with Congressional
enactment of the Civil Monetary Penalties Law (CMPL), Public Law
97-35, to further address health care fraud and abuse (section
1128A of the Act). The CMPL authorizes the Department and the OIG
to impose CMPs, assessments and program exclusions against
individuals and entities who submit false or fraudulent, or
otherwise improper claims for Medicare or Medicaid payment.
"Improper claims" include claims submitted by an excluded
individual or entity for items or services furnished during a
period of program exclusion. To enhance the OIG's ability to
protect the Medicare and Medicaid programs and beneficiaries, the
Medicare and Medicaid Patient and Program Protection Act of 1987,
Public Law 100-93, expanded and revised the OIG's administrative
sanction authorities by, among other things, establishing certain
mandatory and discretionary exclusions for various types of
misconduct. The enactment of HIPAA in 1996 and the Balanced Budget
Act (BBA) of 1997, Public Law 105-33, further expanded the OIG's
sanction authorities. These statutes extended the application and
scope of the current CMP and exclusion authorities beyond programs
funded by the Department to all "Federal health care programs." BBA
also authorized a new CMP authority to be imposed against health
care providers or entities that employ or enter into contracts with
excluded individuals for the provision of services or items to
Federal program beneficiaries. In the discussion that follows, it
should be understood that the prohibitions being described apply to
items and services provided, directly or indirectly, to Federal
program beneficiaries. The ability of an excluded individual or
entity to render items and services to others is not affected by an
OIG exclusion. C. Exclusion from Federal Health Care
Programs The effect of an OIG exclusion from Federal
health care programs is that no Federal health care program payment
may be made for any items or services (1) furnished by an excluded
individual or entity, or (2) directed or prescribed by an excluded
physician (42 CFR 1001.1901). This payment ban applies to all
methods of Federal program reimbursement, whether payment results
from itemized claims, cost reports, fee schedules or a prospective
payment system (PPS). Any items and services furnished by an
excluded individual or entity are not reimbursable under Federal
health care programs. In addition, any items and services furnished
at the medical direction or prescription of an excluded physician
are not reimbursable when the individual or entity furnishing the
services either knows or should know of the exclusion. This
prohibition applies even when the Federal payment itself is made to
another provider, practitioner or supplier that is not excluded.
The prohibition against Federal program payment for items or
services furnished by excluded individuals or entities also extends
to payment for administrative and management services not directly
related to patient care, but that are a necessary component of
providing items and services to Federal program beneficiaries. This
prohibition continues to apply to an individual even if he or she
changes from one health care profession to another while
excluded.(3)In addition, no Federal program
payment may be made to cover an excluded individual's salary,
expenses or fringe benefits, regardless of whether they provide
direct patient care. Set forth below is a listing of some of the
types of items or services that are reimbursed by Federal health
care programs which, when provided by excluded parties, violate an
OIG exclusion. These examples also demonstrate the kinds of items
and services that excluded parties may be furnishing which will
subject their employer or contractor to possible CMP liability.
- Services performed by excluded nurses, technicians or other
excluded individuals who work for a hospital, nursing home, home
health agency or physician practice, where such services are
related to administrative duties, preparation of surgical trays or
review of treatment plans if such services are reimbursed directly
or indirectly (such as through a PPS or a bundled payment) by a
Federal health care program, even if the individuals do not furnish
direct care to Federal program beneficiaries;
- Services performed by excluded pharmacists or other excluded
individuals who input prescription information for pharmacy billing
or who are involved in any way in filling prescriptions for drugs
reimbursed, directly or indirectly, by any Federal health care
program;
- Services performed by excluded ambulance drivers, dispatchers
and other employees involved in providing transportation reimbursed
by a Federal health care program, to hospital patients or nursing
home residents;
- Services performed for program beneficiaries by excluded
individuals who sell, deliver or refill orders for medical devices
or equipment being reimbursed by a Federal health care
program;
- Services performed by excluded social workers who are employed
by health care entities to provide services to Federal program
beneficiaries, and whose services are reimbursed, directly or
indirectly, by a Federal health care program;
- Administrative services, including the processing of claims for
payment, performed for a Medicare intermediary or carrier, or a
Medicaid fiscal agent, by an excluded individual;
- Services performed by an excluded administrator, billing agent,
accountant, claims processor or utilization reviewer that are
related to and reimbursed, directly or indirectly, by a Federal
health care program;
- Items or services provided to a program beneficiary by an
excluded individual who works for an entity that has a contractual
agreement with, and is paid by, a Federal health care program;
and
- Items or equipment sold by an excluded manufacturer or
supplier, used in the care or treatment of beneficiaries and
reimbursed, directly or indirectly, by a Federal health care
program.
D. Violation of an OIG Exclusion By an Excluded Individual
or Entity An excluded party is in violation of its
exclusion if it furnishes to Federal program beneficiaries items or
services for which Federal health care program payment is sought.
An excluded individual or entity that submits a claim for
reimbursement to a Federal health care program, or causes such a
claim to be submitted, may be subject to a CMP of $10,000 for each
item or service furnished during the period that the person or
entity was excluded (section 1128A(a)(1)(D) of the Act). The
individual or entity may also be subject to treble damages for the
amount claimed for each item or service. In addition, since
reinstatement into the programs is not automatic, the excluded
individual may jeopardize future reinstatement into Federal health
care programs (42 CFR 1001.3002). E. Employing an Excluded
Individual or Entity As indicated above, BBA authorizes
the imposition of CMPs against health care providers and entities
that employ or enter into contracts with excluded individuals or
entities to provide items or services to Federal program
beneficiaries (section 1128A(a)(6) of the Act; 42 CFR
1003.102(a)(2)). This authority parallels the CMP for health
maintenance organizations that employ or contract with excluded
individuals (section 1857(g)(1)(G) of the Act). Under the CMP
authority, providers such as hospitals, nursing homes, hospices and
group medical practices may face CMP exposure if they submit claims
to a Federal health care program for health care items or services
provided, directly or indirectly, by excluded individuals or
entities. Thus, a provider or entity that receives Federal health
care funding may only employ an excluded individual in limited
situations. Those situations would include instances where the
provider is both able to pay the individual exclusively with
private funds or from other non-federal funding sources, and where
the services furnished by the excluded individual relate solely to
non-federal program patients. In many instances, the practical
effect of an OIG exclusion is to preclude employment of an excluded
individual in any capacity by a health care provider that receives
reimbursement, indirectly or directly, from any Federal health care
program. F. CMP Liability for Employing or Contracting with
an Excluded Individual or Entity If a
health care provider arranges or contracts (by employment or
otherwise) with an individual or entity who is excluded by the OIG
from program participation for the provision of items or services
reimbursable under such a Federal program, the provider may be
subject to CMP liability if they render services reimbursed,
directly or indirectly, by such a program. CMPs of up to $10,000
for each item or service furnished by the excluded individual or
entity and listed on a claim submitted for Federal program
reimbursement, as well as an assessment of up to three times the
amount claimed and program exclusion may be imposed. For liability
to be imposed, the statute requires that the provider submitting
the claims for health care items or services furnished by an
excluded individual or entity "knows or should know" that the
person was excluded from participation in the Federal health care
programs (section 1128A(a)(6) of the Act; 42 CFR 1003.102(a)(2)).
Providers and contracting entities have an affirmative duty to
check the program exclusion status of individuals and entities
prior to entering into employment or contractual relationships, or
run the risk of CMP liability if they fail to do so. G. How
to Determine If an Individual or Entity is Excluded In
order to avoid potential CMP liability, the OIG urges health care
providers and entities to check the OIG List of Excluded
Individuals/Entities on the OIG web site (www.hhs.gov/oig) prior to
hiring or contracting with individuals or entities. In addition, if
they have not already done so, health care providers should
periodically check the OIG web site for determining the
participation/exclusion status of current employees and
contractors. The web site contains OIG program exclusion
information and is updated in both on-line searchable and
downloadable formats. This information is updated on a regular
basis. The OIG web site sorts the exclusion of individuals and
entities by: (1) the legal basis for the exclusion, (2) the types
of individuals and entities that have been excluded, and (3) the
State where the excluded individual resided at the time they were
excluded or the State where the entity was doing business. In
addition, the entire exclusion file may be downloaded for persons
who wish to set up their own database. Monthly updates are posted
to the downloadable information on the web site.
H. Conclusion In accordance with
the expanded sanction authority provided in HIPAA and BBA, and with
limited exceptions(4), an exclusion from Federal
health care programs effectively precludes an excluded individual
or entity from being employed by, or under contract with, any
practitioner, provider or supplier to provide any items and
services reimbursed by a Federal health care program. This broad
prohibition applies whether the Federal reimbursement is based on
itemized claims, cost reports, fee schedules or PPS. Furthermore,
it should be recognized that an exclusion remains in effect until
the individual or entity has been reinstated to participate in
Federal health care programs in accordance with the procedures set
forth at 42 CFR 1001.3001 through 1001.3005. Reinstatement does not
occur automatically at the end of a term of exclusion, but rather,
an excluded party must apply for reinstatement. If you are an
excluded individual or entity, or are considering hiring or
contracting with an excluded individual or entity, and question
whether or not the employment arrangement may violate the law, the
OIG Advisory Opinion process is available to offer formal binding
guidance on whether an employment or contractual arrangement may be
in violation of the OIG's exclusion and CMP authorities. The
process and procedure for submitting an advisory opinion request
can be found at 42 CFR 1008, or on the OIG web site at
www.hhs.gov/oig. 1. A Federal
health care program is defined as 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 or a State health care program (with the exception of
the Federal Employees Health Benefits Program) (section 1128B(f) of
the Act). The most significant Federal health care programs are
Medicare, Medicaid, Tricare and the Veterans programs. 2. A Federal program beneficiary is
an individual that receives health care benefits that are funded,
in whole or in part, by a Federal health care program. 3. For example, the prohibition
against Federal program payment for items and services would
continue to apply in the situation where an excluded pharmacist
completes his or her medical degree and becomes a licensed
physician. 4. In certain
instances, a State health care program may request a waiver of an
exclusion if an individual or entity is the sole community
physician or the sole source of essential specialized services in a
community (42 CFR 1001.1801(b)).