Be it enacted by the Senate and House of Representa-
tives 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 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 
200 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) 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 con-
duct an assessment to determine the efficacy of si-
multaneous islet-kidney transplants and islet trans-
plants 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 in-
formation in the emerging area of islet cell trans-
plantation, 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 deter-
mine the efficacy of simultaneous islet-kidney trans-
plants and islet transplants after kidney transplants 
for medicare beneficiaries with type 1 diabetes. 
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).