[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[S. 2235 Introduced in Senate (IS)]







106th CONGRESS
  2d Session
                                S. 2235

To amend the Public Health Act to revise the performance standards and 
       certification process for organ procurement organizations.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 9, 2000

Ms. Collins (for herself, Mr. Murkowski, Mr. Dodd, Mr. Torricelli, and 
Mr. Hutchinson) introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
To amend the Public Health Act to revise the performance standards and 
       certification process for organ procurement organizations.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Organ Procurement Organization 
Certification Act of 2000''.

 SEC. 2. 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) An immediate decertification of organ 
                procurement organizations solely on the basis of the 
                performance measures, without an appropriate 
                opportunity to file and a grace period to pursue a 
                corrective action plan.
                    (C) 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 
                corrective action plans and appeals.

 SEC. 3. 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 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;
                            ``(IV) provide for the filing and approval 
                        of a corrective action plan by a qualified 
                        organ procurement organization that fails to 
                        meet the performance standards and a grace 
                        period of not less than 3 years during which 
                        such organization can implement the corrective 
                        action plan without risk of decertification; 
                        and
                            ``(V) provide for a qualified organ 
                        procurement organization to appeal a 
                        decertification to the Secretary on substantive 
                        and procedural grounds;''.
                                 <all>