II

105TH CONGRESS

2D SESSION S. 2201

To delay the effective date of the final rule promulgated by the Secretary

of Health and Human Services regarding the Organ Procurement and

Transplantation Network.

IN THE SENATE OF THE UNITED STATES

JUNE 22, 1998

Mr. TORRICELLI (for himself, Mr. GORTON, Mr. FEINGOLD, Mr. MACK, Mr.

SESSIONS, Mr. THURMOND, Ms. LANDRIEU, Mr. BREAUX, Mr. HOLLINGS, Mr. LAUTENBERG, Mr. KOHL, Mr. INHOFE, Mr. SMITH of Oregon, and Mr. SHELBY) introduced the following bill; which was read

twice and referred to the Committee on Labor and Human Resources

A BILL

To delay the effective date of the final rule promulgated

by the Secretary of Health and Human Services regarding the Organ Procurement and Transplantation Network.

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

3 SECTION 1. FINDINGS.

4 Congress makes the following findings:

5 (1) The national transplant system, established

6 by the National Organ Transplant Act of 1984, has

7 saved over 200,000 lives. In 1998, 20,000 lives were
2

•S 2201 IS

1 saved by donated organs. Approximately 60,000

2 Americans currently are awaiting an organ trans3 plant.

4 (2) Every 16 minutes a new name is added to

5 the national organ waiting list.

6 (3) Every day in the United States, 11 people

7 on the national waiting list die (more than 4,000

8 every year) because there are not enough donated

9 organs.

10 (4) Eliminating the geographic criteria for

11 donor organ allocation, as proposed by the Depart12 ment of Health and Human Services, will have po13 tentially negative consequences for the nation.

14 (5) Eliminating the geographic criteria for

15 donor organ allocation will make organ transplants

16 economically prohibitive for a large percentage of the

17 population, especially for the 22 percent of trans18 plant recipients covered under the medicaid pro19 gram.

20 (6) The following provisions proposed by the

21 Department of Health and Human Services with re22 spect to organ donation are appropriate and work23 able and should be studied—

24 (A) the standardized listing criteria for pa25 tient placement on lists;
3

•S 2201 IS

1 (B) the standardized criteria for determin2 ing current medical status based on objective

3 and measurable medical criteria;

4 (C) the provision of enforcement authority;

5 and

6 (D) the requirement of full and timely dis7 closure by transplant centers of waiting list

8 times and survival statistics to potential pa9 tients.

10 SEC. 2. DELAY OF EFFECTIVE DATE OF FINAL RULE RE11 GARDING ORGAN PROCUREMENT AND

12 TRANSPLANTATION NETWORK.

13 (a) IN GENERAL.—During the 1-year period begin14 ning on the date of the enactment of this Act, the Sec15 retary of Health and Human Services may not modify reg16 ulations that, as of such date, are in effect with respect

17 to the operation of the Organ Procurement and Trans18 plantation Network under section 372 of the Public

19 Health Service Act (42 U.S.C. 274), including regulations

20 under section 1138 of the Social Security Act (42 U.S.C.

21 1320b–8) with respect to such Network. During such 1-

22 year period, the final rule published in the Federal Reg23 ister to establish part 121 in title 42, Code of Federal

24 Regulations, has no legal effect.
4

•S 2201 IS

1 (b) GUIDELINES.—During the 1-year period de2 scribed in subsection (a), the Secretary of Health and

3 Human Services shall consult with appropriate individuals

4 and organizations in the medical community, including na5 tional and local organ donation organizations (including

6 those serving low-income patients), to develop workable

7 guidelines with respect to the operation of the Organ Pro8 curement and Transplantation Network.

9 (c) STUDY.—Prior to the implementation of any

10 modifications to the regulations described in subsection

11 (a), the Secretary of Health and Human Services shall

12 conduct a study to determine the impact of such proposed

13 modifications on indigent care, economic and geographic

14 access to transplantation services, transplantation out15 come and survival rate, and waiting list time by organ.

16 The Secretary shall ensure that any such modifications,

17 together with the results of the study, are open for public

18 comment for a period of at least 90-days prior to the effec19 tive date of such modifications.

Æ