§ 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 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—
(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) 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 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 See References in Text note below. of this title) under paragraph (1)(F).
[Aug. 14, 1935, ch. 531], title XI, § 1138, as added [Pub. L. 99–509, title IX, § 9318(a)], Oct. 21, 1986, [100 Stat. 2009]; amended [Pub. L. 100–203, title IV, § 4039(h)(2)], Dec. 22, 1987, as added [Pub. L. 100–360, title IV, § 411(e)(3)], July 1, 1988, [102 Stat. 775]; amended [Pub. L. 101–239, title VI, § 6003(g)(3)(D)(iv)], Dec. 19, 1989, [103 Stat. 2153]; [Pub. L. 103–432, title I, § 155(a)(1)], Oct. 31, 1994, [108 Stat. 4438]; [Pub. L. 105–33, title IV], §§ 4201(c)(1), 4642, Aug. 5, 1997, [111 Stat. 373], 487.)