Pancreatic Islet Cell Transplantation Act of 2004 - Amends the Public Health Service Act to allow pancreases procured for use in islet cell transplantation or research to be counted for certification purposes for qualified organ procurement organization grants.
Requires the Diabetes Mellitus Interagency Coordinating Committee to include in its annual report an assessment of the Federal activities and programs related to pancreatic islet cell transplantation, which shall address: (1) the adequacy of funding; (2) policies and regulations affecting the supply of pancreata; (3) the effect of xenotransplantation; (4) the effect of the United Network for Organ Sharing policies; (5) the existing mechanisms to collect and coordinate outcome data from trials; (6) implementation of multi-agency clinical investigations; and (7) recommendations for legislation and administrative actions to increase the supply of pancreases.
[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.
<all>
Introduced in Senate
Sponsor introductory remarks on measure. (CR S3166)
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Gregg with an amendment in the nature of a substitute. With written report No. 108-387.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Gregg with an amendment in the nature of a substitute. With written report No. 108-387.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 773.
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