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







108th CONGRESS
  1st Session
                                 S. 518

   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, and Mr. Miller) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 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.

    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 ``Pancreatic Islet Cell 
Transplantation Act of 2003''.

SEC. 2. FINDINGS.

    Congress makes the following findings:
            (1) Approximately 1,000,000 individuals in the United 
        States have juvenile, or Type I, diabetes.
            (2) In individuals with juvenile diabetes, the body's 
        immune system attacks the pancreas and destroys islet cells 
        that produce insulin.
            (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.
            (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.
            (5) Islet cell transplants have been hailed as the most 
        promising development in diabetes since the discovery of 
        insulin.
            (6) Of the approximately 200 individuals treated using 
        variations of the Edmonton Protocol, nearly 80 percent remain 
        insulin independent after 1 year.
            (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.
            (8) Diabetes is the most common cause of kidney failure, 
        accounting for 40 percent of new cases.
            (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.
            (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.

SEC. 3. 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. 4. INTERAGENCY COMMITTEE ON ISLET CELL TRANSPLANTATION.

    (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'').
    (b) Membership.--The Committee shall be composed of a 
representative from--
            (1) the National Institute on Diabetes and Digestive Kidney 
        Diseases, who shall serve as chairperson of the Committee;
            (2) the National Institute of Allergy and Infectious 
        Diseases;
            (3) the National Institute of Environmental Health 
        Sciences;
            (4) the Health Resources and Services Administration;
            (5) the Centers for Medicare and Medicaid Services;
            (6) the Department of Defense;
            (7) the Department of Veterans Affairs;
            (8) the National Aeronautics and Space Administration; and
            (9) other agencies and National Institutes of Health 
        representatives as determined appropriate by the chairperson 
        and Secretary of Health and Human Services.
    (c) Duties.--
            (1) Study.--The Committee shall conduct a study of--
                    (A) the adequacy of Federal research funding for 
                taking advantage of scientific opportunities relating 
                to islet cell transplantation;
                    (B) current policies and regulations affecting the 
                supply of pancreases for islet cell transplantation;
                    (C) the effect of xenotransplantation on advancing 
                islet cell transplantation;
                    (D) the effect of United Network for Organ Sharing 
                variances on pancreas retrieval and islet cell 
                transplantation; and
                    (E) the existing mechanisms to collect and 
                coordinate outcome data from existing islet cell 
                transplantation trials.
            (2) Recommendations.--The Committee shall develop 
        recommendations concerning the matters studied under paragraph 
        (1).
            (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.

SEC. 5. STUDY.

    (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.
    (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--
            (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;
            (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
            (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.
    (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--
            (1) direct measures, such as--
                    (A) post-transplant health care resource 
                utilization; and
                    (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
            (2) indirect measures, such as--
                    (A) time lost at work; and
                    (B) productivity analysis.

SEC. 6. MEDICARE DEMONSTRATION PROJECT.

    (a) Establishment of Project.--
            (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.).
            (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.
    (b) Duration.--The Secretary shall conduct the demonstration 
project under this section for a 5-year period.
    (c) Selection of Participating Facilities.--
            (1) Competitive selection.--Subject to paragraph (2), the 
        Secretary shall select eligible facilities to participate in 
        the project on a competitive basis.
            (2) Limitation.--No more than 6 eligible facilities may 
        participate in the project.
            (3) Eligible facility defined.--In this section, the term 
        eligible facility means a facility that--
                    (A) is eligible to receive payments under section 
                1881 of the Social Security Act (42 U.S.C. 1395rr);
                    (B) has experience performing islet cell 
                transplants; and
                    (C) agrees to provide such data to the Secretary as 
                the Secretary determines is necessary to conduct the 
                evaluation under subsection (d)(1).
    (d) Evaluation and Report.--
            (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.
            (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.
    (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.

SEC. 7. AUTHORIZATION OF APPROPRIATIONS.

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