II

106TH CONGRESS

2D SESSION S. 2625

To amend the Public Health Service Act to revise the performance standards

and certification process for organ procurement organizations.

IN THE SENATE OF THE UNITED STATES

MAY 24, 2000

Ms. COLLINS (for herself, Mr. DODD, Mr. HUTCHINSON, Mr. WELLSTONE,

Mr. TORRICELLI, Mr. MURKOWSKI, Mr. DORGAN, Mr. LIEBERMAN, and

Mr. MOYNIHAN) 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 Service Act to revise the performance standards and certification process for organ

procurement organizations.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. ORGAN PROCUREMENT ORGANIZATION CER4 TIFICATION ACT OF 2000.

5 (a) FINDINGS.—Congress makes the following find6 ings:

7 (1) Organ procurement organizations play an

8 important role in the effort to increase organ dona9 tion in the United States.
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1 (2) The current process for the certification and

2 recertification of organ procurement organizations

3 conducted by the Department of Health and Human

4 Services has created a level of uncertainty that is

5 interfering with the effectiveness of organ procure6 ment organizations in raising the level of organ do7 nation.

8 (3) The General Accounting Office, the Insti9 tute of Medicine, and the Harvard School of Public

10 Health have identified substantial limitations in the

11 organ procurement organization certification and re12 certification process and have recommended changes

13 in that process.

14 (4) The limitations in the recertification process

15 include:

16 (A) An exclusive reliance on population17 based measures of performance that do not ac18 count for the potential in the population for

19 organ donation and do not permit consideration

20 of other outcome and process standards that

21 would more accurately reflect the relative capa22 bility and performance of each organ procure23 ment organization.

24 (B) A lack of due process to appeal to the

25 Secretary of Health and Human Services for
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1 recertification on either substantive or proce2 dural grounds.

3 (5) The Secretary of Health and Human Serv4 ices has the authority under section 1138(b)(1)(A)(i)

5 of the Social Security Act (42 U.S.C. 1320b–

6 8(b)(1)(A)(i)) to extend the period for recertification

7 of an organ procurement organization from 2 to 4

8 years on the basis of its past practices in order to

9 avoid the inappropriate disruption of the nation’s

10 organ system.

11 (6) The Secretary of Health and Human Serv12 ices can use the extended period described in para13 graph (5) for recertification of all organ procure14 ment organizations to—

15 (A) develop improved performance meas16 ures that would reflect organ donor potential

17 and interim outcomes, and to test these meas18 ures to ensure that they accurately measure

19 performance differences among the organ pro20 curement organizations; and

21 (B) improve the overall certification proc22 ess by incorporating process as well as outcome

23 performance measures, and developing equitable

24 processes for appeals.
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1 (b) CERTIFICATION AND RECERTIFICATION OF

2 ORGAN PROCUREMENT ORGANIZATIONS.—Section

3 371(b)(1) of the Public Health Service Act (42 U.S.C.

4 273(b)(1)) is amended—

5 (1) by redesignating subparagraphs (D)

6 through (G) as subparagraphs (E) through (H), re7 spectively;

8 (2) by realigning the margin of subparagraph

9 (F) (as so redesignated) so as to align with subpara10 graph (E) (as so redesignated); and

11 (3) by inserting after subparagraph (C) the fol12 lowing:

13 ‘‘(D) notwithstanding any other provision of

14 law, has met the other requirements of this section

15 and has been certified or recertified by the Secretary

16 within the previous 4-year period as meeting the

17 performance standards to be a qualified organ pro18 curement organization through a process that

19 either—

20 ‘‘(i) granted certification or recertification

21 within such 4-year period with such certification

22 or recertification in effect as of January 1,

23 2000, and remaining in effect through the ear24 lier of—

25 ‘‘(I) January 1, 2002; or
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1 ‘‘(II) the completion of recertification

2 under the requirements of clause (ii); or

3 ‘‘(ii) is defined through regulations that

4 are promulgated by the Secretary by not later

5 than January 1, 2002, that—

6 ‘‘(I) require recertifications of quali7 fied organ procurement organizations not

8 more frequently than once every 4 years;

9 ‘‘(II) rely on outcome and process per10 formance measures that are based on em11 pirical evidence, obtained through reason12 able efforts, of organ donor potential and

13 other related factors in each service area of

14 qualified organ procurement organizations;

15 ‘‘(III) use multiple outcome measures

16 as part of the certification process; and

17 ‘‘(IV) provide for a qualified organ

18 procurement organization to appeal a de19 certification to the Secretary on sub20 stantive and procedural grounds;’’.

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