Organ Procurement Organization Certification Act of 2000

SECTION. 1. SHORT TITLE.

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

SEC. 2. FINDINGS.

    The Congress finds as follows:
            (1) Organ procurement organizations play an important role 
        in the effort to increase organ donation in the United States.
            (2) The current process for 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 organ procurement 
        organization effectiveness 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; and
                    (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)(ii) of the Social 
        Security Act 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 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.

    (a) In General.--Section 1138(b) of the Social Security Act (42 
U.S.C. 1320b-8(b)) is amended--
            (1) in paragraph (1)(A)(ii) by striking ``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);'' and inserting 
        ``under paragraph (2) within the previous 4 years;'';
            (2) by redesignating paragraph (2) as paragraph (3); and
            (3) by inserting after paragraph (1) the following new 
        paragraph:
    ``(2) Not later than January 1, 2002, the Secretary shall set forth 
in regulations the process and performance standards by which an 
organization shall be certified or recertified as a qualified organ 
procurement organization consistent with the following:
            ``(A) Certification or recertification of such an 
        organization shall be made not more frequently than once every 
        4 years.
            ``(B) Performance standards applicable for certification or 
        recertification of an organization shall use--
                    ``(i) 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, and
                    ``(ii) multiple outcome measures, which may or may 
                not be based on empirical evidence.
            ``(C)(i) In the case of a certified qualified organ 
        procurement organization that the Secretary determines does not 
        meet the performance standards for recertification, the 
        organization may submit to the Secretary a corrective action 
        plan.
            ``(ii) If the Secretary approves the corrective action plan 
        submitted under clause (i), the Secretary shall provide for an 
        additional 3-year period during which such organization shall 
        implement the corrective action plan. An organization 
        implementing a corrective action plan shall be treated as being 
        certified by the Secretary during such 3-year period.
The Secretary shall develop and implement appropriate procedures for an 
organization to appeal a decision of the Secretary to deny 
certification or recertification of an organization under this 
paragraph.''.
    (b) Transition Rule.--In the case of an organization that on 
January 1, 2000, has in effect a certification or recertification by 
the Secretary of Health and Human Services as a qualified organ 
procurement organization under section 1138(b)(1)(A)(ii) of the Social 
Security Act (42 U.S.C. 1320b-8(b)(1)(A)(ii)), such certification or 
recertification shall remain in effect until the earlier of January 1, 
2002, or the date on which the Secretary publishes a final rule 
implementing the provisions of 1138(b)(2), as added by subsection (a) 
of this Act.

Summary: Requires the Secretary of Health and Human Services to set forth in regulations the process and performance standards by which an organization shall be so certified or recertified consistent with the following: (1) certification or recertification shall be made no more frequently than once every four years. (2) performance standards shall use outcome and process measures that are based on empirical evidence of organ donor potential and other related factors in each service area of qualified organ procurement organizations and multiple outcome measures, which may or may not be based on empirical evidence. Authorizes a certified qualified organ procurement organization that does not meet such performance standards to submit a corrective action plan to the Secretary. Provides an additional three-year period for an organization to implement an approved plan and treats such organization as certified during such period. Requires the Secretary to implement procedures for appeals of decisions to deny certification or recertification.