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U.S. Code as of:
01/19/04
Section 1320b-8. Hospital protocols for organ procurement and standards for organ procurement agencies
(a)(1) The Secretary shall provide that a hospital or critical
access hospital meeting the requirements of subchapter XVIII or XIX
of this chapter may participate in the program established under
such subchapter only if -
(A) the hospital or critical access hospital establishes
written protocols for the identification of potential organ
donors that -
(i) assure that families of potential organ donors are made
aware of the option of organ or tissue donation and their
option to decline,
(ii) encourage discretion and sensitivity with respect to the
circumstances, views, and beliefs of such families, and
(iii) require that such hospital's designated organ
procurement agency (as defined in paragraph (3)(B)) is notified
of potential organ donors;
(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 274 of this title (in
this section referred to as the "Network"); and
(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 -
(i) the waiver is expected to increase organ donation; and
(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 -
(i) cost effectiveness;
(ii) improvements in quality;
(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
(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 -
(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
(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 -
(A) the term "agreement" means an agreement described in
section 273(b)(3)(A) of this title;
(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) of this
section for the service area in which such hospital is located;
and
(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
subchapter XVIII or XIX of this chapter with respect to organ
procurement costs attributable to payments made to an organ
procurement agency only if the agency -
(A)(i) is a qualified organ procurement organization (as
described in section 273(b) of this title) that is operating
under a grant made under section 273(a) of this title, 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);
(B) meets the requirements that are applicable under such
subchapter for organ procurement agencies;
(C) meets performance-related standards prescribed by the
Secretary;
(D) is a member of, and abides by the rules and requirements
of, the Network;
(E) allocates organs, within its service area and nationally,
in accordance with medical criteria and the policies of the
Network; and
(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
subchapter.
(2) The Secretary may not designate more than one organ
procurement organization for each service area (described in
section 273(b)(1)(E) (!1) of this title) under paragraph (1)(F).
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