[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