(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 OF ISLET CELL TRANSPLANTATION. 
(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. 
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 Sec-
retary 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 demonstra-
tion 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.
Æ