I
107TH CONGRESS
2D SESSION
H. R. 5462
To increase the supply of pancreatic islet cells for research, to provide better
coordination of Federal efforts and information on islet cell transplan-
tation, and to collect the data necessary to move islet cell transplantation
from an experimental procedure to a standard therapy.
IN THE HOUSE OF REPRESENTATIVES
SEPTEMBER 25, 2002
Mr. NETHERCUTT (for himself, Ms. DEGETTE, Mr. WELDON of Pennsylvania,
and Mr. LAFALCE) introduced the following bill; which was referred to
the Committee on Energy and Commerce
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 Representa-
tives 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 2002’’.
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 de-
stroys islet cells that produce insulin.
(3) Insulin is not a cure, and individuals with
juvenile diabetes face the constant threat of dev-
astating complications, a drastic reduction in quality
of life, and a shortened life span.
(4) The development of the ‘‘Edmonton Pro-
tocol’’ and subsequent variations of that protocol, in-
volving the transplant of insulin-producing pan-
creatic islet cells into individuals with juvenile diabe-
tes, 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
70 patients who have received islet cell transplants
using variations of the Edmonton Protocol have
maintained normal glucose levels without insulin in-
jections 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) The Federal Government should promote
policies and regulations to increase the supply of
pancreases for research, to coordinate efforts and in-
formation in the emerging area of islet cell trans-
plantation, and to collect the data necessary to move
islet cell transplantation from an experimental proce-
dure to a standard therapy covered by insurance.
SEC. 3. ORGAN PROCUREMENT ORGANIZATION CERTIFI-
CATION.
Section 371 of the Public Health Service Act (42
U.S.C. 273) is amended by adding at the end the fol-
lowing:
‘‘(c) Pancreases procured by an organ procurement
organization and used for islet cell transplantation or re-
search shall be counted for purposes of certification or re-
certification under subsection (b).’’.
SEC. 4. INTERAGENCY COMMITTEE ON ISLET CELL TRANS-
PLANTATION.
(a) ESTABLISHMENT.—There is established within
the Department of Health and Human Services the Inter-
agency 
Committee 
on 
Islet 
Cell 
Transplantation
(in this section referred to as the ‘‘Committee’’).
(b) MEMBERSHIP.—The Committee shall be com-
posed 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 Dis-
eases.
(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 Administra-
tion.
(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 Administra-
tion.
(9) Such members as the Secretary of Health
and Human Services, in consultation with the chair-
person of the Committee, determines appropriate
and appoints to represent agencies (including the
national research institutes of the National Insti-
tutes 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 fund-
ing for taking advantage of scientific opportuni-
ties relating to islet cell transplantation;
(B) current policies and regulations affect-
ing the supply of pancreases for islet cell trans-
plantation;
(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 there-
after, 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 sup-
ply of pancreases available for islet cell transplan-
tation.
SEC. 5. STUDY.
(a) IN GENERAL.—The Secretary of Health and
Human Services shall request that the Institute of Medi-
cine 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-effec-
tiveness 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 meas-
ures shall include—
(1) clinical outcomes, including episodes of
hypoglycemia unawareness and the long-term devel-
opment of diabetes-related clinical complications, in-
cluding nephropathy, neuropathy, retinopathy, and
vascular disease;
(2) health-related quality of life outcomes, in-
cluding patient levels of worry with respect to fear
of hypoglycemia episodes, the ability to perform
basic life and work-associated functions, and the im-
pact 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 med-
ical management (such as continued daily insulin in-
jections) and whole pancreas transplantation, for pa-
tients with juvenile diabetes.
(c) COST-EFFECTIVENESS
ANALYSIS.—Cost-effec-
tiveness 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 utiliza-
tion due to diabetes complications, including
nephropathy, neuropathy, retinopathy, and vas-
cular 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.
Æ