SEC. 1128.
[42 U.S.C. 1320a-7] (a)
MANDATORY EXCLUSION.—The Secretary shall
exclude the following individuals and entities from
participation in any Federal health care program (as defined in
section 1128B(f)):
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(1) Conviction of program-related crimes.—Any individual
or entity that has been convicted of a criminal offense related
to the delivery of an item or service under title XVIII or under
any State health care program.
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(2) Conviction relating to patient abuse.—Any individual
or entity that has been convicted, under Federal or State law,
of a criminal offense relating to neglect or abuse of patients
in connection with the delivery of a health care item or
service.
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(3) FELONY CONVICTION RELATING TO HEALTH CARE
FRAUD.—Any individual or entity that has been
convicted for an offense which occurred after the date of the
enactment of the Health Insurance Portability and Accountability
Act of 1996[38], under Federal or State law, in connection
with the delivery of a health care item or service or with
respect to any act or omission in a health care program (other
than those specifically described in paragraph (1)) operated by
or financed in whole or in part by any Federal, State, or local
government agency, of a criminal offense consisting of a felony
relating to fraud, theft, embezzlement, breach of fiduciary
responsibility, or other financial misconduct.
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(4) FELONY CONVICTION RELATING TO CONTROLLED
SUBSTANCE.—Any individual or entity that has been
convicted for an offense which occurred after the date of the
enactment of the Health Insurance Portability and Accountability
Act of 1996, under Federal or State law, of a criminal offense
consisting of a felony relating to the unlawful manufacture,
distribution, prescription, or dispensing of a controlled
substance.
(b)
PERMISSIVE EXCLUSION.—The Secretary may
exclude the following individuals and entities from
participation in any Federal health care program (as defined in
section 1128B(f)):
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(1) CONVICTION RELATING TO FRAUD.—Any
individual or entity that has been convicted for an offense
which occurred after the date of the enactment of the Health
Insurance Portability and Accountability Act of 1996, under
Federal or State law—
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(A) of a criminal offense consisting of a misdemeanor relating
to fraud, theft, embezzlement, breach of fiduciary
responsibility, or other financial misconduct—
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(i) in connection with the delivery of a health care item or
service, or
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(ii) with respect to any act or omission in a health care
program (other than those specifically described in subsection
(a)(1)) operated by or financed in whole or in part by any
Federal, State, or local government agency; or
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(B) of a criminal offense relating to fraud, theft,
embezzlement, breach of fiduciary responsibility, or other
financial misconduct with respect to any act or omission in a
program (other than a health care program) operated by or
financed in whole or in part by any Federal, State, or local
government agency.
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(2) Conviction relating to obstruction of an
investigation.—Any individual or entity that has been
convicted, under Federal or State law, in connection with the
interference with or obstruction of any investigation into any
criminal offense described in paragraph (1) or in subsection
(a).
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(3) Misdemeanor conviction relating to controlled
substance.—Any individual or entity that has been
convicted, under Federal or State law, of a criminal offense
consisting of a misdemeanor relating to the unlawful
manufacture, distribution, prescription, or dispensing of a
controlled substance.
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(4) LICENSE REVOCATION OR SUSPENSION.—ANY
INDIVIDUAL OR ENTITY—
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(A) whose license to provide health care has been revoked or
suspended by any State licensing authority, or who otherwise
lost such a license or the right to apply for or renew such a
license, for reasons bearing on the individual's or entity's
professional competence, professional performance, or financial
integrity, or
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(B) who surrendered such a license while a formal disciplinary
proceeding was pending before such an authority and the
proceeding concerned the individual's or entity's professional
competence, professional performance, or financial integrity.
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(5) EXCLUSION OR SUSPENSION UNDER FEDERAL OR STATE
HEALTH CARE PROGRAM.—Any individual or entity which
has been suspended or excluded from participation, or otherwise
sanctioned, under—
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(A) any Federal program, including programs of the Department of
Defense or the Department of Veterans Affairs, involving the
provision of health care, or
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(B) a State health care program,
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for reasons bearing on the individual's or entity's professional
competence, professional performance, or financial integrity.
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(6) CLAIMS FOR EXCESSIVE CHARGES OR UNNECESSARY
SERVICES AND FAILURE OF CERTAIN ORGANIZATIONS TO FURNISH
MEDICALLY NECESSARY SERVICES.—Any individual or entity
that the Secretary determines—
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(A) has submitted or caused to be submitted bills or requests
for payment (where such bills or requests are based on charges
or cost) under title XVIII or a State health care program
containing charges (or, in applicable cases, requests for
payment of costs) for items or services furnished substantially
in excess of such individual's or entity's usual charges (or, in
applicable cases, substantially in excess of such individual's
or entity's costs) for such items or services, unless the
Secretary finds there is good cause for such bills or requests
containing such charges or costs;
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(B) has furnished or caused to be furnished items or services to
patients (whether or not eligible for benefits under title XVIII
or under a State health care program) substantially in excess of
the needs of such patients or of a quality which fails to meet
professionally recognized standards of health care;
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(C) is—
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(i) a health maintenance organization (as defined in section 1903(m)) providing items and services under a State plan
approved under title XIX, or
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(ii) an entity furnishing services under a waiver approved under
section 1915(b)(1),
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and has failed substantially to provide medically necessary
items and services that are required (under law or the contract
with the State under title XIX) to be provided to individuals
covered under that plan or waiver, if the failure has adversely
affected (or has a substantial likelihood of adversely
affecting) these individuals; or
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(D) is an entity providing items and services as an eligible
organization under a risk-sharing contract under section 1876 and has failed substantially to provide medically necessary
items and services that are required (under law or such
contract) to be provided to individuals covered under the
risk-sharing contract, if the failure has adversely
affected (or has a substantial likelihood of adversely
affecting) these individuals.
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(7) FRAUD, KICKBACKS, AND OTHER PROHIBITED
ACTIVITIES.—Any individual or entity that the
Secretary determines has committed an act which is described in
section 1128A, 1128B, or 1129.
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(8) ENTITIES CONTROLLED BY A SANCTIONED
INDIVIDUAL.—Any entity with respect to which the
Secretary determines that a person—
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(A)(i) who has a direct or indirect ownership or control
interest of 5 percent or more in the entity or with an ownership
or control interest (as defined in section 1124(a)(3)) in that
entity,
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(ii) who is an officer, director, agent, or managing employee
(as defined in section 1126(b)) of that entity; or
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(iii) who was described in clause (i) but is no longer so
described because of a transfer of ownership or control
interest, in anticipation of (or following) a conviction,
assessment, or exclusion described in subparagraph (B) against
the person, to an immediate family member (as defined in
subsection (j)(1)) or a member of the household of the person
(as defined in subsection (j)(2)) who continues to maintain an
interest described in such clause—
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is a person—
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(B)(i) who has been convicted of any offense described in
subsection (a) or in paragraph (1), (2), or (3) of this
subsection;
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(ii) against whom a civil monetary penalty has been assessed
under section 1128A or 1129; or
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(iii) who has been excluded from participation under a program
under title XVIII or under a State health care program.
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(9) FAILURE TO DISCLOSE REQUIRED
INFORMATION.—Any entity that did not fully and
accurately make any disclosure required by section 1124, section 1124A, or section 1126.
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(10) FAILURE TO SUPPLY REQUESTED INFORMATION ON
SUBCONTRACTORS AND SUPPLIERS.—Any disclosing entity
(as defined in section 1124(a)(2)) that fails to supply (within
such period as may be specified by the Secretary in regulations)
upon request specifically addressed to the entity by the
Secretary or by the State agency administering or supervising
the administration of a State health care program—
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(A) full and complete information as to the ownership of a
subcontractor (as defined by the Secretary in regulations) with
whom the entity has had, during the previous 12 months, business
transactions in an aggregate amount in excess of $25,000, or
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(B) full and complete information as to any significant business
transactions (as defined by the Secretary in regulations),
occurring during the five-year period ending on the date
of such request, between the entity and any wholly owned
supplier or between the entity and any subcontractor.
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(11) FAILURE TO SUPPLY PAYMENT
INFORMATION.—Any individual or entity furnishing items
or services for which payment may be made under title XVIII or a
State health care program that fails to provide such information
as the Secretary or the appropriate State agency finds necessary
to determine whether such payments are or were due and the
amounts thereof, or has refused to permit such examination of
its records by or on behalf of the Secretary or that agency as
may be necessary to verify such information.
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(12) FAILURE TO GRANT IMMEDIATE ACCESS.—Any
individual or entity that fails to grant immediate access, upon
reasonable request (as defined by the Secretary in regulations)
to any of the following:
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(A) To the Secretary, or to the agency used by the Secretary,
for the purpose specified in the first sentence of section 1864(a) (relating to compliance with conditions of participation
or payment).
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(B) To the Secretary or the State agency, to perform the reviews
and surveys required under State plans under paragraphs (26),
(31), and (33) of section 1902(a) and under section 1903(g).
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(C) To the Inspector General of the Department of Health and
Human Services, for the purpose of reviewing records, documents,
and other data necessary to the performance of the statutory
functions of the Inspector General.
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(D) To a State medicaid fraud control unit (as defined in
section 1903(q)), for the purpose of conducting activities
described in that section.
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(13) FAILURE TO TAKE CORRECTIVE ACTION.—Any
hospital that fails to comply substantially with a corrective
action required under section 1886(f)(2)(B).
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(14) DEFAULT ON HEALTH EDUCATION LOAN OR SCHOLARSHIP
OBLIGATIONS.—Any individual who the Secretary
determines is in default on repayments of scholarship
obligations or loans in connection with health professions
education made or secured, in whole or in part, by the Secretary
and with respect to whom the Secretary has taken all reasonable
steps available to the Secretary to secure repayment of such
obligations or loans, except that (A) the Secretary shall not
exclude pursuant to this paragraph a physician who is the sole
community physician or sole source of essential specialized
services in a community if a State requests that the physician
not be excluded, and (B) the Secretary shall take into account,
in determining whether to exclude any other physician pursuant
to this paragraph, access of beneficiaries to physician services
for which payment may be made under title XVIII or XIX.
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(15) INDIVIDUALS CONTROLLING A SANCTIONED
ENTITY.—
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(A) Any individual—
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(i) who has a direct or indirect ownership or control interest
in a sanctioned entity and who knows or should know (as defined
in section 1128A(i)(6)) of the action constituting the basis for
the conviction or exclusion described in subparagraph (B); or
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(ii) who is an officer or managing employee (as defined in
section 1126(b)) of such an entity.
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(B) For purposes of subparagraph (A), the term “sanctioned
entity” means an entity—
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(i) that has been convicted of any offense described in
subsection (a) or in paragraph (1), (2), or (3) of this
subsection; or
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(ii) that has been excluded from participation under a program
under title XVIII or under a State health care program.
(c)
NOTICE, EFFECTIVE DATE, AND PERIOD OF
EXCLUSION.—(1) An exclusion under this section or
under section 1128A shall be effective at such time and upon
such reasonable notice to the public and to the individual or
entity excluded as may be specified in regulations consistent
with paragraph (2).
(2)(A) Except as provided in subparagraph (B), such an exclusion
shall be effective with respect to services furnished to an
individual on or after the effective date of the exclusion.
(B) Unless the Secretary determines that the health and safety
of individuals receiving services warrants the exclusion taking
effect earlier, an exclusion shall not apply to payments made
under title XVIII or under a State health care program
for—
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(i) inpatient institutional services furnished to an individual
who was admitted to such institution before the date of the
exclusion, or
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(ii) home health services and hospice care furnished to an
individual under a plan of care established before the date of
the exclusion,
until the passage of 30 days after the effective date of the
exclusion.
(3)(A) The Secretary shall specify, in the notice of exclusion
under paragraph (1) and the written notice under section 1128A,
the minimum period (or, in the case of an exclusion of an
individual under subsection (b)(12) or in the case described in
subparagraph (G), the period) of the exclusion.
(B) Subject to subparagraph (G), in the case of an exclusion
under subsection (a), the minimum period of exclusion shall be
not less than five years, except that, upon the request of a
State, the Secretary may waive the exclusion under subsection
(a)(1) in the case of an individual or entity that is the sole
community physician or sole source of essential specialized
services in a community. The Secretary's decision whether to
waive the exclusion shall not be reviewable.
(C) In the case of an exclusion of an individual under
subsection (b)(12), the period of the exclusion shall be equal
to the sum of—
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(i) the length of the period in which the individual failed to
grant the immediate access described in that subsection, and
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(ii) an additional period, not to exceed 90 days, set by the
Secretary.
(D) Subject to subparagraph (G), in the case of an exclusion of
an individual or entity under paragraph (1), (2), or (3) of
subsection (b), the period of the exclusion shall be 3 years,
unless the Secretary determines in accordance with published
regulations that a shorter period is appropriate because of
mitigating circumstances or that a longer period is appropriate
because of aggravating circumstances.
(E) In the case of an exclusion of an individual or entity under
subsection (b)(4) or (b)(5), the period of the exclusion shall
not be less than the period during which the individual's or
entity's license to provide health care is revoked, suspended,
or surrendered, or the individual or the entity is excluded or
suspended from a Federal or State health care program.
(F) In the case of an exclusion of an individual or entity under
subsection (b)(6)(B), the period of the exclusion shall be not
less than 1 year.
(G) In the case of an exclusion of an individual under
subsection (a) based on a conviction occurring on or after the
date of the enactment of this subparagraph, if the individual
has (before, on, or after such date) been convicted—
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(i) on one previous occasion of one or more offenses for which
an exclusion may be effected under such subsection, the period
of the exclusion shall be not less than 10 years, or
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(ii) on 2 or more previous occasions of one or more offenses for
which an exclusion may be effected under such subsection, the
period of the exclusion shall be permanent.
(d)
NOTICE TO STATE AGENCIES AND EXCLUSION UNDER STATE
HEALTH CARE PROGRAMS.—(1) Subject to paragraph (3),
the Secretary shall exercise the authority under this section
and section 1128A in a manner that results in an individual's or
entity's exclusion from all the programs under title XVIII and
all the State health care programs in which the individual or
entity may otherwise participate.
(2) The Secretary shall promptly notify each appropriate State
agency administering or supervising the administration of each
State health care program (and, in the case of an exclusion
effected pursuant to subsection (a) and to which section 304(a)(5) of the Controlled Substances Act[39] may apply, the
Attorney General)—
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(A) of the fact and circumstances of each exclusion effected
against an individual or entity under this section or section 1128A, and
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(B) of the period (described in paragraph (3)) for which the
State agency is directed to exclude the individual or entity
from participation in the State health care program.
(3)(A) Except as provided in subparagraph (B), the period of the
exclusion under a State health care program under paragraph (2)
shall be the same as any period of exclusion under title XVIII.
(B)(i) The Secretary may waive an individual's or entity's
exclusion under a State health care program under paragraph (2)
if the Secretary receives and approves a request for the waiver
with respect to the individual or entity from the State agency
administering or supervising the administration of the program.
(ii) A State health care program may provide for a period of
exclusion which is longer than the period of exclusion under
title XVIII.
(e)
NOTICE TO STATE LICENSING AGENCIES.—The
Secretary shall—
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(1) promptly notify the appropriate State or local agency or
authority having responsibility for the licensing or
certification of an individual or entity excluded (or directed
to be excluded) from participation under this section or section 1128A, of the fact and circumstances of the exclusion,
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(2) request that appropriate investigations be made and
sanctions invoked in accordance with applicable State law and
policy, and
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(3) request that the State or local agency or authority keep the
Secretary and the Inspector General of the Department of Health
and Human Services fully and currently informed with respect to
any actions taken in response to the request.
(f)
NOTICE, HEARING, AND JUDICIAL REVIEW.—(1)
Subject to paragraph (2), any individual or entity that is
excluded (or directed to be excluded) from participation under
this section is entitled to reasonable notice and opportunity
for a hearing thereon by the Secretary to the same extent as is
provided in section 205(b), and to judicial review of the
Secretary's final decision after such hearing as is provided in
section 205(g), except that, in so applying such sections and
section 205(l), any reference therein to the Commissioner of
Social Security or the Social Security Administration shall be
considered a reference to the Secretary or the Department of
Health and Human Services, respectively.
(2) Unless the Secretary determines that the health or safety of
individuals receiving services warrants the exclusion taking
effect earlier, any individual or entity that is the subject of
an adverse determination under subsection (b)(7) shall be
entitled to a hearing by an administrative law judge (as
provided under section 205(b)) on the determination under
subsection (b)(7) before any exclusion based upon the
determination takes effect.
(3) The provisions of section 205(h) shall apply with respect to
this section and sections 1128A, 1129, and 1156 to the same
extent as it is applicable with respect to title II, except
that, in so applying such section and section 205(l), any
reference therein to the Commissioner of Social Security shall
be considered a reference to the Secretary.
(g)
APPLICATION FOR TERMINATION OF
EXCLUSION.—(1) An individual or entity excluded (or
directed to be excluded) from participation under this section
or section 1128A may apply to the Secretary, in the manner
specified by the Secretary in regulations and at the end of the
minimum period of exclusion provided under subsection (c)(3) and
at such other times as the Secretary may provide, for
termination of the exclusion effected under this section or
section 1128A.
(2) The Secretary may terminate the exclusion if the Secretary
determines, on the basis of the conduct of the applicant which
occurred after the date of the notice of exclusion or which was
unknown to the Secretary at the time of the exclusion,
that—
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(A) there is no basis under subsection (a) or (b) or section 1128A(a) for a continuation of the exclusion, and
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(B) there are reasonable assurances that the types of actions
which formed the basis for the original exclusion have not
recurred and will not recur.
(3) The Secretary shall promptly notify each appropriate State
agency administering or supervising the administration of each
State health care program (and, in the case of an exclusion
effected pursuant to subsection (a) and to which section 304(a)(5) of the Controlled Substances Act[40] may apply, the
Attorney General) of the fact and circumstances of each
termination of exclusion made under this subsection.
(h)
DEFINITION OF STATE HEALTH CARE PROGRAM.—For
purposes of this section and sections 1128A and 1128B, the term
“State health care program” means—
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(1) a State plan approved under title XIX,
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(2) any program receiving funds under title V or from an
allotment to a State under such title,
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(3) any program receiving funds under title XX or from an
allotment to a State under such title, or
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(4) a State child health plan approved under title XXI.
(i)
CONVICTED DEFINED.—For purposes of
subsections (a) and (b), an individual or entity is considered
to have been “convicted” of a criminal
offense—
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(1) when a judgment of conviction has been entered against the
individual or entity by a Federal, State, or local court,
regardless of whether there is an appeal pending or whether the
judgment of conviction or other record relating to criminal
conduct has been expunged;
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(2) when there has been a finding of guilt against the
individual or entity by a Federal, State, or local court;
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(3) when a plea of guilty or nolo contendere by the individual
or entity has been accepted by a Federal, State, or local
court;or
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(4) when the individual or entity has entered into participation
in a first offender, deferred adjudication, or other arrangement
or program where judgment of conviction has been withheld.
(j)
DEFINITION OF IMMEDIATE FAMILY MEMBER AND MEMBER OF
HOUSEHOLD.—For purposes of subsection (b)(8)(A)(iii):
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(1) The term “immediate family member” means, with
respect to a person—
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(A) the husband or wife of the person;
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(B) the natural or adoptive parent, child, or sibling of the
person;
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(C) the stepparent, stepchild, stepbrother, or stepsister of the
person;
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(D) the father-, mother-, daughter-,
son-, brother-, or sister-in-law of the
person;
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(E) the grandparent or grandchild of the person; and
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(F) the spouse of a grandparent or grandchild of the person.
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(2) The term “member of the household” means, with
respect to any person, any individual sharing a common abode as
part of a single family unit with the person, including domestic
employees and others who live together as a family unit, but not
including a roomer or boarder.