| (a) The OIG must exclude from participation in Titles
V, XIX, XX, and CHIP programs, as applicable, any person if it determines
that the person:
(1) has been excluded from participation in Medicare
or any other federal health care programs;
(2) is a provider whose health care license, certification,
or other qualifying requirement to perform certain types of service
is revoked, suspended, voluntarily surrendered, or otherwise terminated
such that the provider is unable to legally perform their profession
due to loss of their license, certification, or other qualifying requirement;
(3) has been convicted of a criminal offense related
to the delivery of an item or service under Medicare or a state health
care program, including the performance of management or administrative
services relating to the delivery of items or services under any such
program;
(4) has been convicted, under federal or state law,
of a felony relating to fraud, theft, embezzlement, breach of fiduciary
responsibility, or other financial misconduct:
(A) in connection with the delivery of a health care
item or service, including the performance of management or administrative
services relating to the delivery of such items or services; or
(B) with respect to any act or omission in a health
care program (other than Medicare and a State health care program)
operated by, or financed in whole or in part, by any federal, state
or local government agency;
(5) has been convicted, under federal or state law,
of a felony relating to the unlawful manufacture, distribution, prescription
or dispensing of a controlled substance, as defined under federal
or state law. This applies to a person that:
(A) is, or has ever been, a health care practitioner,
person, or supplier;
(B) holds, or has held, a direct or indirect ownership
or control interest (as defined in §1124(a)(3) of the Social
Security Act) in an entity that is a health care person or supplier,
or is, or has ever been, an officer, director, agent or managing employee
(as defined in §1126(b) of the Social Security Act) of such an
entity; or
(C) is or has ever been, employed in any capacity in
the health care industry;
(6) is an MCO or other entity furnishing services under
a waiver approved under §1915(b)(1) of the Social Security Act
that has an affiliate relationship with a person, and that person:
(A) has been convicted:
(i) of an offense that is a ground for mandatory exclusion
under this section;
(ii) of an offense under federal or state law consisting
of a misdemeanor relating to fraud, theft, embezzlement, breach of
fiduciary responsibility, or other financial misconduct:
(I) in connection with the delivery of a health care
item or service;
(II) with respect to any act or omission in a health
care program (other than those specifically described in paragraph
(1) of this subsection) operated by or financed in whole or in part
by any federal, state, or local government agency; or
(III) 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;
(iii) of an offense under federal or state law in connection
with the interference with or obstruction of any investigation related
to:
(I) an offense that is a ground for mandatory exclusion
under this section; or
(II) the use of funds received, directly or indirectly,
from any federal health care program;
(iv) of an offense under federal or state law for acts
that took place after January 1, 2010, in connection with the interference
with or obstruction of any audit related to:
(I) an offense that is a ground for mandatory exclusion
under this section; or
(II) the use of funds received, directly or indirectly,
from any federal health care program;
(v) has had civil money penalties or assessments imposed
under §1128A of the Social Security Act (federal false claims);
or
(vi) has been excluded from participation in Medicare
or any of the state health care programs or CHIP; and
(B) that person:
(i) has an ownership interest in the entity;
(ii) is the owner of a whole or part interest in any
mortgage, deed of trust, note or other obligation secured (in whole
or in part) by the entity or any of the property assets thereof, in
which whole or part interest is equal to or exceeds five percent of
the total property and assets of the entity;
(iii) is an officer or director of the entity, if the
entity is organized as a corporation;
(iv) is a partner in the entity, if the entity is organized
as a partnership;
(v) is an agent of the entity;
(vi) is a managing employee, that is, a an person (including
a general manager, business manager, administrator, or director) who
exercises operational or managerial control over the entity or part
thereof, or directly or indirectly conducts the day-to-day operations
of the entity or part thereof; or
(vii) was formerly described in clauses (i) - (vi)
of this subparagraph, but is no longer so described because of a transfer
of ownership or control interest to an immediate family member or
a member of the person's household in anticipation of or following
a conviction, assessment of a civil monetary penalty, or imposition
of an exclusion;
(7) is an individual and has an ownership or control
interest or a substantial contractual relationship in or is an officer
or managing employee of a sanctioned entity, and who knew or should
have known of an action that constituted the basis for a conviction
or mandatory exclusion of the sanctioned entity; or
(8) is convicted, pleads guilty or pleads nolo contendere
to an offense arising from a fraudulent act under the Medicaid program,
which results in injury to a person age 65 or older, a person with
a disability, or a person younger than 18 years of age.
(b) The OIG may exclude a person without sending prior
notice of intent to exclude in the following circumstances:
(1) The OIG determines that the person is subject to
mandatory exclusion under subsection (a) of this section and the person
may be placing the health and/or safety of persons receiving services
under an HHS program at risk; or
(2) a person who is subject to mandatory exclusion
under subsection (a) of this section fails:
(A) to grant immediate access to the OIG or to a requesting
agency upon reasonable request;
(B) to allow the OIG or a requesting agency to conduct
any duties that are necessary to the performance of their official
functions; or
(C) to provide to the OIG or a requesting agency as
requested copies or originals of any records, documents, or other
items, as determined necessary by the OIG or the requesting agency.
(c) When the OIG issues a final notice of exclusion,
the notice includes the requirements and procedures for reinstatement.
(d) Due process.
(1) After receiving a notice of intent to exclude,
a person has a right to the informal resolution process in accordance
with §371.1613 of this subchapter (relating to Informal Resolution
Process) unless the exclusion is required under subsection (a)(1)
of this section or under 42 C.F.R. §1001.101.
(2) A person may request an administrative appeal hearing
in accordance with §371.1615 of this subchapter (relating to
Appeals) after receipt of a final notice of exclusion unless the exclusion
is required under subsection (a)(1) of this section or under 42 C.F.R. §1001.101.
The OIG must receive the written request for an appeal no later than
15 days after the date the person receives final notice.
(3) When the exclusion is based on the existence of
a criminal conviction; a civil fraud finding; a civil judgment imposing
liability by federal, state, or local court; a determination by another
government agency or board; any other prior determination; or provisions
within a settlement agreement, the individual or entity subject to
exclusion may not collaterally attack the underlying determination,
either on substantive or procedural grounds, in an administrative
appeal.
(e) Scope and effect of exclusion.
(1) An exclusion becomes effective on the following:
(A) the date the person's health care services or items
became ineligible for federal financial participation as described
in subsection (a)(1) of this section;
(B) the effective date the person lost its license,
certification, or other qualifying requirement as described in subsection
(a)(2) of this section;
Cont'd... |
