SEC. 1138.
[42 U.S.C. 1320b-8] (a)(1)
The Secretary shall provide that a hospital
or critical access hospital meeting the requirements of title XVIII
or XIX may participate in the program established under such title
only if—
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(A) the hospital or critical access hospital establishes written
protocols for the identification of potential organ donors that—
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(i) assure that families of potential organ donors are made
aware of the option of organ or tissue donation and their option
to decline,
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(ii) encourage discretion and sensitivity with respect to the
circumstances, views, and beliefs of such families, and
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(iii) require that such hospital's designated organ procurement
agency (as defined in paragraph (3)(B)) is notified of potential
organ donors;
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(B) in the case of a hospital in which organ transplants are
performed, the hospital is a member of, and abides by the rules
and requirements of, the Organ Procurement and Transplantation
Network established pursuant to section 372 of the Public Health
Service Act[85] (in this section referred to as the “Network”);
and
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(C) the hospital or critical access hospital has an agreement
(as defined in paragraph (3)(A)) only with such hospital's designated
organ procurement agency.
(2)(A) The Secretary shall grant a waiver of the requirements
under subparagraphs (A)(iii) and (C) of paragraph (1) to a hospital
or critical access hospital desiring to enter into an agreement
with an organ procurement agency other than such hospital's designated
organ procurement agency if the Secretary determines that—
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(i) the waiver is expected to increase organ donation; and
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(ii) the waiver will assure equitable treatment of patients
referred for transplants within the service area served by such
hospital's designated organ procurement agency and within the
service area served by the organ procurement agency with which
the hospital seeks to enter into an agreement under the waiver.
(B) In making a determination under subparagraph (A), the Secretary
may consider factors that would include, but not be limited to—
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(i) cost effectiveness;
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(ii) improvements in quality;
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(iii) whether there has been any change in a hospital's designated
organ procurement agency due to a change made on or after December
28, 1992, in the definitions for metropolitan statistical areas
(as established by the Office of Management and Budget); and
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(iv) the length and continuity of a hospital's relationship
with an organ procurement agency other than the hospital's designated
organ procurement agency;
except that nothing in this subparagraph shall be construed
to permit the Secretary to grant a waiver that does not meet the
requirements of subparagraph (A).
(C) Any hospital or critical access hospital seeking a waiver
under subparagraph (A) shall submit an application to the Secretary
containing such information as the Secretary determines appropriate.
(D) The Secretary shall—
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(i) publish a public notice of any waiver application received
from a hospital or critical access hospital under this paragraph
within 30 days of receiving such application; and
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(ii) prior to making a final determination on such application
under subparagraph (A), offer interested parties the opportunity
to submit written comments to the Secretary during the 60-day
period beginning on the date such notice is published.
(3) For purposes of this subsection—
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(A) the term “agreement” means an agreement
described in seciton 371(b)(3)(A) of the Public Health Service
Act[86];
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(B) the term “designated organ procurement agency”
means, with respect to a hospital or critical access hospital,
the organ procurement agency designated pursuant to subsection
(b) for the service area in which such hospital is located; and
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(C) the term “organ” means a human kidney,
liver, heart, lung, pancreas, and any other human organ or tissue
specified by the Secretary for purposes of this subsection.
(b)(1)
The Secretary shall provide that payment
may be made under title XVIII or XIX with respect to organ procurement
costs attributable to payments made to an organ procurement agency
only if the agency—
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(A)(i) is a qualified organ procurement organization (as described
in section 371(b) of the Public Health Service Act) that is operating
under a grant made under section 371(a) of such Act, or (ii) has
been certified or recertified by the Secretary within the previous
2 years (4 years if the Secretary determines appropriate for an
organization on the basis of its past practices) as meeting the
standards to be a qualified organ procurement organization (as
so described);
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(B) meets the requirements that are applicable under such title
for organ procurement agencies;
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(C) meets performance-related standards prescribed by the Secretary;
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(D) is a member of, and abides by the rules and requirements
of, the Network;
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(E) allocates organs, within its service area and nationally,
in accordance with medical criteria and the policies of the Network;
and
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(F) is designated by the Secretary as an organ procurement
organization payments to which may be treated as organ procurement
costs for purposes of reimbursement under such title.
(2) The Secretary may not designate more than one organ procurement
organization for each service area (described in section 371(b)(1)(E)
of the Public Health Service Act) under paragraph (1)(F).