[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 518 Reported in Senate (RS)]






                                                       Calendar No. 773
108th CONGRESS
  2d Session
                                 S. 518

                          [Report No. 108-387]

   To increase the supply of pancreatic islet cells for research, to 
provide better coordination of Federal efforts and information on islet 
 cell transplantation, and to collect the data necessary to move islet 
   cell transplantation from an experimental procedure to a standard 
                                therapy.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 5, 2003

  Ms. Collins (for herself, Mrs. Murray, Mr. Breaux,  Mr. Miller, Mr. 
Bunning, Mr. Lott, Mr. Dayton, Mr. Allen, Mr. Inhofe, Mrs. Lincoln, Mr. 
Daschle, Mr. Chambliss, Mr. Smith, Mr. Dorgan, Mr. Bingaman, Mr. Reed, 
 Mr. McCain, Mr. Biden, Mr. Harkin, Mr. Chafee, Mr. Craig, Mr. Hagel, 
 Mr. Fitzgerald, Mr. Cochran, Mr. Domenici, Mr. Bond, Mr. Durbin, Mr. 
Sessions, Mr. Ensign, Mr. Alexander, Mr. Warner, Mr. Kerry, Mr. Graham 
 of South Carolina, Mr. Corzine, Mr. Dodd, Mrs. Clinton, Mr. Schumer, 
 Mr. Nelson of Nebraska, Ms. Mikulski, Mr. Lieberman, Mr. Coleman, Mr. 
  Feingold, Mrs. Boxer, Mr. Burns, Mr. Lautenberg, Ms. Landrieu, Mr. 
Talent, Ms. Stabenow, Mr. DeWine, Ms. Murkowski, Mr. Graham of Florida, 
Mr. Nelson of Florida, and Mr. Sarbanes) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

                            October 7, 2004

                Reported by Mr. Gregg, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 A BILL


 
   To increase the supply of pancreatic islet cells for research, to 
provide better coordination of Federal efforts and infomation on islet 
 cell transplantation, and to collect the data necessary to move islet 
   cell transplantation from an experimental procedure to a standard 
                                therapy.

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

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Pancreatic Islet Cell 
Transplantation Act of 2003''.</DELETED>

<DELETED>SEC. 2. FINDINGS.</DELETED>

<DELETED>    Congress makes the following findings:</DELETED>
        <DELETED>    (1) Approximately 1,000,000 individuals in the 
        United States have juvenile, or Type I, diabetes.</DELETED>
        <DELETED>    (2) In individuals with juvenile diabetes, the 
        body's immune system attacks the pancreas and destroys islet 
        cells that produce insulin.</DELETED>
        <DELETED>    (3) Insulin is not a cure and individuals with 
        juvenile diabetes face the constant threat of devastating 
        complications as well as a drastic reduction in their quality 
        of life and shortening of their life span.</DELETED>
        <DELETED>    (4) The development of the ``Edmonton Protocol'' 
        and subsequent variations of that protocol, involving the 
        transplant of insulin-producing pancreatic islet cells into 
        individuals with juvenile diabetes, have brought us within 
        reach of a cure.</DELETED>
        <DELETED>    (5) Islet cell transplants have been hailed as the 
        most promising development in diabetes since the discovery of 
        insulin.</DELETED>
        <DELETED>    (6) Of the approximately 200 individuals treated 
        using variations of the Edmonton Protocol, nearly 80 percent 
        remain insulin independent after 1 year.</DELETED>
        <DELETED>    (7) One of the key hurdles in expanding the number 
        of patients enrolled in these protocols is the insufficient 
        number of pancreases available for islet cell 
        transplantation.</DELETED>
        <DELETED>    (8) Diabetes is the most common cause of kidney 
        failure, accounting for 40 percent of new cases.</DELETED>
        <DELETED>    (9) While a significant percentage of individuals 
        with Type I diabetes will experience kidney failure and become 
        eligible for benefits under the medicare program, insufficient 
        data exists to conduct an assessment to determine the efficacy 
        of simultaneous islet-kidney transplants or islet transplants 
        after kidney transplants for individuals with Type I diabetes 
        and kidney failure.</DELETED>
        <DELETED>    (10) The Federal Government should promote 
        policies and regulations to increase the supply of pancreata 
        for research, to coordinate efforts and information in the 
        emerging area of islet cell transplantation, to collect the 
        data necessary to move islet cell transplantation from an 
        experimental procedure to a standard therapy covered by 
        insurance, and to assess the efficacy of islet transplantation 
        for individuals with Type I diabetes and kidney 
        failure.</DELETED>

<DELETED>SEC. 3. ORGAN PROCUREMENT ORGANIZATION 
              CERTIFICATION.</DELETED>

<DELETED>    Section 371 of the Public Health Service Act (42 U.S.C. 
273) is amended by adding at the end the following:</DELETED>
<DELETED>    ``(c) Pancreases procured by an organ procurement 
organization and used for islet cell transplantation or research shall 
be counted for purposes of certification or recertification under 
subsection (b).''.</DELETED>

<DELETED>SEC. 4. INTERAGENCY COMMITTEE ON ISLET CELL 
              TRANSPLANTATION.</DELETED>

<DELETED>    (a) Establishment.--There is established within the 
Department of Health and Human Services the Interagency Committee on 
Islet Cell Transplantation (in this section referred to as the 
``Committee'').</DELETED>
<DELETED>    (b) Membership.--The Committee shall be composed of a 
representative from--</DELETED>
        <DELETED>    (1) the National Institute on Diabetes and 
        Digestive Kidney Diseases, who shall serve as chairperson of 
        the Committee;</DELETED>
        <DELETED>    (2) the National Institute of Allergy and 
        Infectious Diseases;</DELETED>
        <DELETED>    (3) the National Institute of Environmental Health 
        Sciences;</DELETED>
        <DELETED>    (4) the Health Resources and Services 
        Administration;</DELETED>
        <DELETED>    (5) the Centers for Medicare and Medicaid 
        Services;</DELETED>
        <DELETED>    (6) the Department of Defense;</DELETED>
        <DELETED>    (7) the Department of Veterans Affairs;</DELETED>
        <DELETED>    (8) the National Aeronautics and Space 
        Administration; and</DELETED>
        <DELETED>    (9) other agencies and National Institutes of 
        Health representatives as determined appropriate by the 
        chairperson and Secretary of Health and Human 
        Services.</DELETED>
<DELETED>    (c) Duties.--</DELETED>
        <DELETED>    (1) Study.--The Committee shall conduct a study 
        of--</DELETED>
                <DELETED>    (A) the adequacy of Federal research 
                funding for taking advantage of scientific 
                opportunities relating to islet cell 
                transplantation;</DELETED>
                <DELETED>    (B) current policies and regulations 
                affecting the supply of pancreases for islet cell 
                transplantation;</DELETED>
                <DELETED>    (C) the effect of xenotransplantation on 
                advancing islet cell transplantation;</DELETED>
                <DELETED>    (D) the effect of United Network for Organ 
                Sharing variances on pancreas retrieval and islet cell 
                transplantation; and</DELETED>
                <DELETED>    (E) the existing mechanisms to collect and 
                coordinate outcome data from existing islet cell 
                transplantation trials.</DELETED>
        <DELETED>    (2) Recommendations.--The Committee shall develop 
        recommendations concerning the matters studied under paragraph 
        (1).</DELETED>
        <DELETED>    (3) Report.--Not later than 1 year after the date 
        of enactment of this Act and annually thereafter, the Committee 
        shall submit a report to the Secretary of Health and Human 
        Services and the appropriate committees of Congress that shall 
        contain a detailed statement of the findings and conclusions of 
        the Committee, together with recommendations for such 
        legislation and administrative actions as the committee 
        considers appropriate to increase the supply of pancreases 
        available for islet cell transplantation.</DELETED>

<DELETED>SEC. 5. STUDY.</DELETED>

<DELETED>    (a) In General.--The Secretary of Health and Human 
Services shall request that the Institute of Medicine conduct, or 
contract with another entity to conduct, a study on the impact of islet 
cell transplantation on the health-related quality of life and the 
economic outcomes for individuals with juvenile diabetes and the cost-
effectiveness of such treatment.</DELETED>
<DELETED>    (b) Matters Studied.--The study authorized under this 
section shall examine and consider the health-related quality of life 
of juvenile diabetes patients before and after pancreatic cell 
transplantation. Outcome measures shall include--</DELETED>
        <DELETED>    (1) clinical outcomes, including episodes of 
        hypoglycemia unawareness and the long-term development of 
        diabetes-related clinical complications, including nephropathy, 
        neuropathy, retinopathy, and vascular disease;</DELETED>
        <DELETED>    (2) health-related quality of life outcomes, 
        including patient levels of worry with respect to fear of 
        hypoglycemia episodes, the ability to perform basic life and 
        work-associated functions, and the impact on the quality of 
        life of family members and caregivers; and</DELETED>
        <DELETED>    (3) the cost-effectiveness of pancreatic islet 
        cell transplantation, as compared to both standard medical 
        management (such as continued daily insulin injections) and 
        whole pancreas transplantation, for patients with juvenile 
        diabetes.</DELETED>
<DELETED>    (c) Cost-Effectiveness Analysis.--Cost-effectiveness 
analysis, as described in subsection (b)(3), shall include standard 
health profile instruments to assess post-treatment costs and benefits, 
including--</DELETED>
        <DELETED>    (1) direct measures, such as--</DELETED>
                <DELETED>    (A) post-transplant health care resource 
                utilization; and</DELETED>
                <DELETED>    (B) long-term health care resource 
                utilization due to diabetes complications, including 
                nephropathy, neuropathy, retinopathy, and vascular 
                disease which can extend to include sight loss and limb 
                loss; and</DELETED>
        <DELETED>    (2) indirect measures, such as--</DELETED>
                <DELETED>    (A) time lost at work; and</DELETED>
                <DELETED>    (B) productivity analysis.</DELETED>

<DELETED>SEC. 6. MEDICARE DEMONSTRATION PROJECT.</DELETED>

<DELETED>    (a) Establishment of Project.--</DELETED>
        <DELETED>    (1) In general.--The Secretary of Health and Human 
        Services, acting through the Administrator of the Centers for 
        Medicare & Medicaid Services and in consultation with the 
        Director of the National Institutes of Health and the 
        Administrator of the Agency for Healthcare Research and Quality 
        (in this section referred to as the ``Secretary'') shall 
        establish a demonstration project (in this section referred to 
        as the ``project'') to assess the efficacy of pancreatic islet 
        cell transplantation for individuals with Type I diabetes, who 
        are medically determined to have end-stage renal disease, and 
        who are beneficiaries under the medicare program under title 
        XVIII of the Social Security Act (42 U.S.C. 1395 et 
        seq.).</DELETED>
        <DELETED>    (2) Assessment of islet transplants.--The project 
        shall assess the efficacy of simultaneous islet-kidney 
        transplants as well as islet transplants after a kidney 
        transplant for individuals with Type I diabetes and kidney 
        failure.</DELETED>
<DELETED>    (b) Duration.--The Secretary shall conduct the 
demonstration project under this section for a 5-year period.</DELETED>
<DELETED>    (c) Selection of Participating Facilities.--</DELETED>
        <DELETED>    (1) Competitive selection.--Subject to paragraph 
        (2), the Secretary shall select eligible facilities to 
        participate in the project on a competitive basis.</DELETED>
        <DELETED>    (2) Limitation.--No more than 6 eligible 
        facilities may participate in the project.</DELETED>
        <DELETED>    (3) Eligible facility defined.--In this section, 
        the term eligible facility means a facility that--</DELETED>
                <DELETED>    (A) is eligible to receive payments under 
                section 1881 of the Social Security Act (42 U.S.C. 
                1395rr);</DELETED>
                <DELETED>    (B) has experience performing islet cell 
                transplants; and</DELETED>
                <DELETED>    (C) agrees to provide such data to the 
                Secretary as the Secretary determines is necessary to 
                conduct the evaluation under subsection 
                (d)(1).</DELETED>
<DELETED>    (d) Evaluation and Report.--</DELETED>
        <DELETED>    (1) Evaluation.--The Secretary shall conduct an 
        evaluation of the outcomes under the project to assess the 
        efficacy of pancreatic islet cell transplantation for 
        individuals with Type I diabetes who are medically determined 
        to have end-stage renal disease.</DELETED>
        <DELETED>    (2) Report.--Not later than 120 days after the 
        date on which the project is completed, the Secretary shall 
        submit to Congress a report on the evaluation conducted under 
        paragraph (1) together with such recommendations for 
        legislative and administrative actions that the Secretary 
        determines are appropriate.</DELETED>
<DELETED>    (e) Waiver Authority.--The Secretary may waive such 
requirements of titles XI and XVIII of the Social Security Act (42 
U.S.C. 1301 et seq. and 1395 et seq.) as may be necessary for the 
purposes of carrying out the project.</DELETED>

<DELETED>SEC. 7. AUTHORIZATION OF APPROPRIATIONS.</DELETED>

<DELETED>    There are authorized to be appropriated such sums as may 
be necessary to carry out this Act.</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Pancreatic Islet Cell 
Transplantation Act of 2004''.

SEC. 2. ORGAN PROCUREMENT ORGANIZATION CERTIFICATION.

    Section 371 of the Public Health Service Act (42 U.S.C. 273) is 
amended by adding at the end the following:
    ``(c) Pancreases procured by an organ procurement organization and 
used for islet cell transplantation or research shall be counted for 
purposes of certification or recertification under subsection (b).''.

SEC. 3. ANNUAL ASSESSMENT ON PANCREATIC ISLET CELL TRANSPLANTATION.

    Section 429 of the Public Health Service Act (42 U.S.C. 285c-3) is 
amended by adding at the end the following:
    ``(d) In each annual report prepared by the Diabetes Mellitus 
Interagency Coordinating Committee pursuant to subsection (c), the 
Committee shall include an assessment of the Federal activities and 
programs related to pancreatic islet cell transplantation. Such 
assessment shall, at a minimum, address the following:
            ``(1) The adequacy of Federal funding for taking advantage 
        of scientific opportunities relating to pancreatic islet cell 
        transplantation.
            ``(2) Current policies and regulations affecting the supply 
        of pancreata for islet cell transplantation.
            ``(3) The effect of xenotransplantation on advancing 
        pancreatic islet cell transplantation.
            ``(4) The effect of United Network for Organ Sharing 
        policies regarding pancreas retrieval and islet cell 
        transplantation.
            ``(5) The existing mechanisms to collect and coordinate 
        outcomes data from existing islet cell transplantation trials.
            ``(6) Implementation of multiagency clinical investigations 
        of pancreatic islet cell transplantation.
            ``(7) Recommendations for such legislation and 
        administrative actions as the Committee considers appropriate 
        to increase the supply of pancreases available for islet cell 
        transplantation.''.




                                                       Calendar No. 773

108th CONGRESS

  2d Session

                                 S. 518

                          [Report No. 108-387]

_______________________________________________________________________

                                 A BILL

   To increase the supply of pancreatic islet cells for research, to 
provide better coordination of Federal efforts and information on islet 
 cell transplantation, and to collect the data necessary to move islet 
   cell transplantation from an experimental procedure to a standard 
                                therapy.

_______________________________________________________________________

                            October 7, 2004

                       Reported with an amendment