
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 23, 2000]
[Document not affected by Public Laws enacted between
  January 23, 2000 and December 4, 2001]
[CITE: 42USC1320b-8]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                       CHAPTER 7--SOCIAL SECURITY
 
   SUBCHAPTER XI--GENERAL PROVISIONS, PEER REVIEW, AND ADMINISTRATIVE 
                             SIMPLIFICATION
 
                       Part A--General Provisions
 
Sec. 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) of 
this title) under paragraph (1)(F).

(Aug. 14, 1935, ch. 531, title XI, Sec. 1138, as added Pub. L. 99-509, 
title IX, Sec. 9318(a), Oct. 21, 1986, 100 Stat. 2009; amended Pub. L. 
100-203, title IV, Sec. 4039(h)(2), Dec. 22, 1987, as added Pub. L. 100-
360, title IV, Sec. 411(e)(3), July 1, 1988, 102 Stat. 775; amended Pub. 
L. 101-239, title VI, Sec. 6003(g)(3)(D)(iv), Dec. 19, 1989, 103 Stat. 
2153; Pub. L. 103-432, title I, Sec. 155(a)(1), Oct. 31, 1994, 108 Stat. 
4438; Pub. L. 105-33, title IV, Secs. 4201(c)(1), 4642, Aug. 5, 1997, 
111 Stat. 373, 487.)


                               Amendments

    1997--Subsec. (a). Pub. L. 105-33, Sec. 4201(c)(1), substituted 
``critical access'' for ``rural primary care'' wherever appearing.
    Subsec. (b)(1)(A)(ii). Pub. L. 105-33, Sec. 4642, substituted ``2 
years (4 years if the Secretary determines appropriate for an 
organization on the basis of its past practices)'' for ``two years''.
    1994--Subsec. (a)(1)(A)(iii). Pub. L. 103-432, Sec. 155(a)(1)(A), 
amended cl. (iii) generally. Prior to amendment, cl. (iii) read as 
follows: ``require that an organ procurement agency designated by the 
Secretary pursuant to subsection (b)(1)(F) of this section be notified 
of potential organ donors; and''.
    Subsec. (a)(1)(C). Pub. L. 103-432, Sec. 155(a)(1)(B), added subpar. 
(C).
    Subsec. (a)(2). Pub. L. 103-432, Sec. 155(a)(1)(C)(ii), added par. 
(2). Former par. (2) redesignated (3).
    Subsec. (a)(3). Pub. L. 103-432, Sec. 155(a)(1)(D), amended par. (3) 
generally. Prior to amendment, par. (3) read as follows: ``For purposes 
of this subsection, 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.''
    Pub. L. 103-432, Sec. 155(a)(1)(C)(i), redesignated par. (2) as (3).
    1989--Subsec. (a)(1). Pub. L. 101-239 substituted ``hospital or 
rural primary care hospital'' for ``hospital'' in two places preceding 
cl. (i) of subpar. (A).
    1988--Subsec. (a)(1)(B). Pub. L. 100-360 added Pub. L. 100-203, 
Sec. 4039(h)(2), see 1987 Amendment note below.
    1987--Subsec. (a)(1)(B). Pub. L. 100-203, Sec. 4039(h)(2), as added 
by Pub. L. 100-360, substituted ``in'' for ``In'' at beginning.


                    Effective Date of 1997 Amendment

    Amendment by section 4201(c)(1) of Pub. L. 105-33 applicable to 
services furnished on or after Oct. 1, 1997, see section 4201(d) of Pub. 
L. 105-33, set out as a note under section 1395f of this title.


                    Effective Date of 1994 Amendment

    Section 155(a)(3) of Pub. L. 103-432 provided that: ``The amendments 
made by paragraph (1) [amending this section] shall apply to hospitals 
and rural primary care hospitals participating in the programs under 
titles XVIII and XIX of the Social Security Act [subchapters XVIII and 
XIX of this chapter] beginning January 1, 1996.''


                    Effective Date of 1988 Amendment

    Except as specifically provided in section 411 of Pub. L. 100-360, 
amendment by Pub. L. 100-360, as it relates to a provision in the 
Omnibus Budget Reconciliation Act of 1987, Pub. L. 100-203, effective as 
if included in the enactment of that provision in Pub. L. 100-203, see 
section 411(a) of Pub. L. 100-360, set out as a Reference to OBRA; 
Effective Date note under section 106 of Title 1, General Provisions.


                             Effective Date

    Section 9318(b) of Pub. L. 99-509, as amended by Pub. L. 100-119, 
title I, Sec. 107(c), Sept. 29, 1987, 101 Stat. 784; Pub. L. 100-203, 
title IV, Sec. 4009(g)(1), Dec. 22, 1987, 101 Stat. 1330-58, provided 
that:
    ``(1) Section 1138(a) of the Social Security Act [subsec. (a) of 
this section] shall apply to hospitals participating in the programs 
under titles XVIII and XIX of such Act [subchapters XVIII and XIX of 
this chapter] as of November 21, 1987.''
    ``(2) Section 1138(b) of such Act [subsec. (b) of this section] 
shall apply to costs of organs procured on or after March 31, 1988.''
    [Pub. L. 100-203, title IV, Sec. 4009(g)(2), Dec. 22, 1987, 101 
Stat. 1330-58, provided that: ``The amendment made by paragraph (1) 
[amending this note] shall be effective as if included in the enactment 
of the Omnibus Budget Reconciliation Act of 1986 [Pub. L. 99-509].'']


           Existing Agreements With Organ Procurement Agencies

    Section 155(a)(2) of Pub. L. 103-432 provided that: ``Any hospital 
or rural primary care hospital which has an agreement (as defined in 
section 1138(a)(3)(A) of the Social Security Act [subsec. (a)(3)(A) of 
this section]) with an organ procurement agency other than such 
hospital's designated organ procurement agency (as defined in section 
1138(a)(3)(B) of such Act) on the date of the enactment of this section 
[Oct. 31, 1994] shall, if such hospital desires to continue such 
agreement on and after the effective date of the amendments made by 
paragraph (1) [see Effective Date of 1994 Amendment note above], submit 
an application to the Secretary for a waiver under section 1138(a)(2) of 
such Act not later than January 1, 1996, and such agreement may continue 
in effect pending the Secretary's determination with respect to such 
application.''
