[Congressional Record (Bound Edition), Volume 146 (2000), Part 7]
[Senate]
[Page 9763]
[From the U.S. Government Publishing Office, www.gpo.gov]



                  PUBLIC HEALTH SERVICE ACT AMENDMENT

  Mr. SMITH of New Hampshire. Mr. President, I ask unanimous consent 
that the Health Committee be discharged from further consideration of 
S. 2625, and the Senate then proceed to its immediate consideration.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The clerk will report the bill by title.
  The legislative clerk read as follows:

       A bill (S. 2625) to amend the Public Health Service Act to 
     revise the performance standards and certification process 
     for organ procurement organizations.

  There being no objection, the Senate proceeded to the consideration 
of the bill.
  Mr. SMITH of New Hampshire. Mr. President, I ask unanimous consent 
that the bill be read a third time and passed, the motion to reconsider 
be laid upon the table, and that any statements relating to the bill be 
printed in the Record.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The bill (S. 2625) was read a third time and passed, as follows:

                                S. 2625

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. ORGAN PROCUREMENT ORGANIZATION CERTIFICATION ACT 
                   OF 2000.

       (a) Findings.--Congress makes the following findings:
       (1) Organ procurement organizations play an important role 
     in the effort to increase organ donation in the United 
     States.
       (2) The current process for the certification and 
     recertification of organ procurement organizations conducted 
     by the Department of Health and Human Services has created a 
     level of uncertainty that is interfering with the 
     effectiveness of organ procurement organizations in raising 
     the level of organ donation.
       (3) The General Accounting Office, the Institute of 
     Medicine, and the Harvard School of Public Health have 
     identified substantial limitations in the organ procurement 
     organization certification and recertification process and 
     have recommended changes in that process.
       (4) The limitations in the recertification process include:
       (A) An exclusive reliance on population-based measures of 
     performance that do not account for the potential in the 
     population for organ donation and do not permit consideration 
     of other outcome and process standards that would more 
     accurately reflect the relative capability and performance of 
     each organ procurement organization.
       (B) A lack of due process to appeal to the Secretary of 
     Health and Human Services for recertification on either 
     substantive or procedural grounds.
       (5) The Secretary of Health and Human Services has the 
     authority under section 1138(b)(1)(A)(i) of the Social 
     Security Act (42 U.S.C. 1320b-8(b)(1)(A)(i)) to extend the 
     period for recertification of an organ procurement 
     organization from 2 to 4 years on the basis of its past 
     practices in order to avoid the inappropriate disruption of 
     the nation's organ system.
       (6) The Secretary of Health and Human Services can use the 
     extended period described in paragraph (5) for 
     recertification of all organ procurement organizations to--
       (A) develop improved performance measures that would 
     reflect organ donor potential and interim outcomes, and to 
     test these measures to ensure that they accurately measure 
     performance differences among the organ procurement 
     organizations; and
       (B) improve the overall certification process by 
     incorporating process as well as outcome performance 
     measures, and developing equitable processes for appeals.
       (b) Certification and Recertification of Organ Procurement 
     Organizations.--Section 371(b)(1) of the Public Health 
     Service Act (42 U.S.C. 273(b)(1)) is amended--
       (1) by redesignating subparagraphs (D) through (G) as 
     subparagraphs (E) through (H), respectively;
       (2) by realigning the margin of subparagraph (F) (as so 
     redesignated) so as to align with subparagraph (E) (as so 
     redesignated); and
       (3) by inserting after subparagraph (C) the following:
       ``(D) notwithstanding any other provision of law, has met 
     the other requirements of this section and has been certified 
     or recertified by the Secretary within the previous 4-year 
     period as meeting the performance standards to be a qualified 
     organ procurement organization through a process that 
     either--
       ``(i) granted certification or recertification within such 
     4-year period with such certification or recertification in 
     effect as of January 1, 2000, and remaining in effect through 
     the earlier of--
       ``(I) January 1, 2002; or
       ``(II) the completion of recertification under the 
     requirements of clause (ii); or
       ``(ii) is defined through regulations that are promulgated 
     by the Secretary by not later than January 1, 2002, that--
       ``(I) require recertifications of qualified organ 
     procurement organizations not more frequently than once every 
     4 years;
       ``(II) rely on outcome and process performance measures 
     that are based on empirical evidence, obtained through 
     reasonable efforts, of organ donor potential and other 
     related factors in each service area of qualified organ 
     procurement organizations;
       ``(III) use multiple outcome measures as part of the 
     certification process; and
       ``(IV) provide for a qualified organ procurement 
     organization to appeal a decertification to the Secretary on 
     substantive and procedural grounds;''.

                          ____________________