[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1068 Introduced in House (IH)]







108th CONGRESS
  1st Session
                                H. R. 1068

   To increase the supply of pancreatic islet cells for research, to 
provide better coordination of Federal efforts and information on islet 
cell transplantation, to collect the data necessary to move islet cell 
 transplantation from an experimental procedure to a standard therapy, 
  and to provide for a demonstration project on Medicare coverage of 
  pancreatic islet cell transplantation for beneficiaries with type 1 
               diabetes who have end-stage renal disease.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 4, 2003

 Mr. Nethercutt (for himself, Ms. DeGette, Mr. Becerra, Mr. Weldon of 
Pennsylvania, Mr. Rangel, Ms. Hart, and Mr. Cunningham) introduced the 
   following bill; which was referred to the Committee on Energy and 
  Commerce, and in addition to the Committee on Ways and Means, for a 
 period to be subsequently determined by the Speaker, in each case for 
consideration of such provisions as fall within the jurisdiction of the 
                          committee concerned

_______________________________________________________________________

                                 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, to collect the data necessary to move islet cell 
 transplantation from an experimental procedure to a standard therapy, 
  and to provide for a demonstration project on Medicare coverage of 
  pancreatic islet cell transplantation for beneficiaries with type 1 
               diabetes who have end-stage renal disease.

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Pancreatic Islet 
Cell Transplantation Act of 2003''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title.
Sec. 2. Findings.
Sec. 3. Organ procurement organization certification.
Sec. 4. Interagency Committee on Islet Cell Transplantation.
Sec. 5. Study of islet cell transplantation.
Sec. 6. Medicare pancreatic islet cell transplant demonstration 
                            project.
Sec. 7. Authorization of appropriations.

SEC. 2. FINDINGS.

    The Congress makes the following findings:
            (1) Approximately 1,000,000 individuals in the United 
        States have juvenile, or Type 1, 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, 
        a drastic reduction in quality of life, and a shortened 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) Currently 80 percent of the approximately 200 patients 
        who have received islet cell transplants using variations of 
        the Edmonton Protocol have maintained normal glucose levels 
        without insulin injections 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) While a significant percentage of individuals with type 
        1 diabetes will experience kidney failure and become Medicare-
        eligible through the end stage renal disease program, 
        insufficient data exist to conduct an assessment to determine 
        the efficacy of simultaneous islet-kidney transplants and islet 
        transplants after kidney transplants for individuals with type 
        1 diabetes.
            (9) The Federal Government should promote policies and 
        regulations to increase the supply of pancreases 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 create a 
        medicare demonstration project to determine the efficacy of 
        simultaneous islet-kidney transplants and islet transplants 
        after kidney transplants for medicare beneficiaries with type 1 
        diabetes.

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 the following:
            (1) 1 member appointed by the Director of the National 
        Institute on Diabetes and Digestive Kidney Diseases, which 
        member shall serve as chairperson of the Committee.
            (2) 1 member appointed by the Director of the National 
        Institute of Allergy and Infectious Diseases.
            (3) 1 member appointed by the Director of the National 
        Institute of Environmental Health Sciences.
            (4) 1 member appointed by the Administrator of the Health 
        Resources and Services Administration.
            (5) 1 member appointed by the Administrator of the Centers 
        for Medicare and Medicaid Services.
            (6) 1 member appointed by the Secretary of Defense.
            (7) 1 member appointed by the Secretary of Veterans 
        Affairs.
            (8) 1 member appointed by the Administrator of the National 
        Aeronautics and Space Administration.
            (9) Such members as the Secretary of Health and Human 
        Services, in consultation with the chairperson of the 
        Committee, determines appropriate and appoints to represent 
agencies (including the national research institutes of the National 
Institutes of Health) that are not listed in paragraphs (1) through 
(8).
    (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 the Congress 
        containing 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 OF ISLET CELL TRANSPLANTATION.

    (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 PANCREATIC ISLET CELL TRANSPLANT DEMONSTRATION 
              PROJECT.

    (a) Establishment.--In order to test the efficacy of pancreatic 
islet cell transplantation, not later than 120 days after the date of 
the enactment of this Act, the Secretary of Health and Human Services 
shall establish a demonstration project which provides over a 5-year 
period for payment under the medicare program under title XVIII of the 
Social Security Act for pancreatic islet cell transplantation in the 
case of medicare beneficiaries who have type 1 (juvenile) diabetes and 
have end stage renal disease.
    (b) Evaluation and Report.--The Secretary shall conduct an 
evaluation of the outcomes of the demonstration project. Not later than 
120 days after the date of completion of the demonstration project, the 
Secretary shall submit to Congress a report on the project, including 
recommendations for such legislative and administrative action as the 
Secretary deems appropriate.

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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