39–010 

Calendar No. 773

108TH CONGRESS REPORT " SENATE ! 2d Session 108–387

THE PANCREATIC ISLET CELL TRANSPLANTATION ACT 

OF 2004

OCTOBER 7, 2004.—Ordered to be printed 

Mr. GREGG, from the Committee on Health, Education, Labor, and 

Pensions, submitted the following 

R E P O R T 

[To accompany S. 518] 

The Committee on Health, Education, Labor, and Pensions, to 

which was referred the bill (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, having considered 

the same, reports favorably thereon with an amendment in the nature of a substitute and recommends that the bill (as amended) do 

pass.

CONTENTS 

Page 

I. Purpose and need for legislation .................................................................. 2

II. Summary ........................................................................................................ 2

III. History of legislation and votes in committee ............................................. 2

IV. Explanation of bill and committee views ..................................................... 3

V. Cost estimate .................................................................................................. 3

VI. Regulatory impact statement ........................................................................ 4

VII. Application of law to the legislative branch ................................................ 4

VIII. Section-by-section analysis ............................................................................ 4

IX. Changes in existing law ................................................................................ 4

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I. PURPOSE AND NEED FOR LEGISLATION

Diabetes is a lifelong disease that affects people of every age, 

race, and nationality. According to the National Diabetes Information Clearinghouse, a service of the National Institute of Diabetes, 

Digestive and Kidney Diseases, 17 million Americans—6.2 percent 

of the population—suffer from diabetes, and about 800,000 new 

cases are diagnosed each year. Type 1 diabetes, frequently referred 

to as juvenile diabetes, usually starts early in life and renders individuals insulin-dependent for life. Currently, there is no method to 

prevent or cure Type 1 diabetes, and available treatments, including insulin injections, have only limited success in controlling its 

consequences.

Pancreatic islet cell transplantation is an important advance in 

diabetes treatment. Once implanted, the new islet cells release insulin into the patient’s bloodstream in response to glucose. This 

new procedure has helped up to 80% of patients become insulinindependent up to one year post-transplantation. 

However, a shortage of donor pancreata is a barrier to higher 

transplant rates. In 2001, approximately 1,800 pancreata were donated and only 500 were available for islet cell transplantation and 

research. At the same time, more than one million people suffer 

from juvenile diabetes. 

Current Federal regulations do not credit organ procurement organizations (OPOs) for harvesting pancreases for islet cell transplantation toward their certification or recertification. 

II. SUMMARY

S. 518 amends the Public Health Service Act to include 

pancreases procured for islet cell transplantation for certification 

purposes of organ procurement organizations. 

The legislation also requires the Diabetes Mellitus Interagency 

Coordinating Committee to annually assess Federal activities and 

programs related to pancreatic islet cell transplantation. 

III. HISTORY OF LEGISLATION AND VOTES IN COMMITTEE

On March 5, 2003, Senator Collins (for herself) and Senators 

Murray, Breaux and Miller introduced S. 518, Pancreatic Islet Cell 

Transplantation Act of 2003. On March 2, 2004, Senator Collins 

(for herself) and Senators Murray, Warner, Bingaman, Allen, Feingold, Cochran, Lautenberg, Hagel, Reed, Smith, Ensign and 

DeWine introduced S. 2158, Pancreatic Islet Cell Transplantation 

of 2004. 

On September 20, 2004, Senator Gregg offered a substitute 

amendment to S. 518 with previously agreed language from S. 

2158. S. 518, as amended, was approved by the committee by unanimous consent. 

Previously, Section 6 of S. 518 was incorporated into the Medicare Modernization Act. It created a Medicare Demonstration 

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 are Medicare beneficiaries. 

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IV. EXPLANATION OF BILL AND COMMITTEE VIEWS

This legislation is intended to assist and encourage those parties 

interested in the successful development of islet cell research and 

transplantation to participate actively in the national discourse on 

this important subject. The provisions contained in the legislation 

are not intended to alter the authority of the OPTN as the policy 

making body for solid organ allocation. 

V. COST ESTIMATE

U.S. CONGRESS, 

CONGRESSIONAL BUDGET OFFICE, 

Washington, DC, October 7, 2004. 

Hon. JUDD GREGG, Chairman, Committee on Health, Education, Labor, and Pensions, 

U.S. Senate, Washington, DC. 

DEAR MR. CHAIRMAN: The Congressional Budget Office has prepared the enclosed cost estimate for S. 518, the Pancreatic Islet 

Cell Transplantation Act of 2004. 

If you wish further details on this estimate, we will be pleased 

to provide them. The CBO staff contact is Christopher J. Topoleski. 

Sincerely, 

DOUGLAS HOLTZ-EAKIN, Director. 

Enclosure.

S. 518.—Pancreatic Islet Cell Transplantation Act of 2004

S. 518 would require that organizations that procure pancreases 

for islet cell transplant or research be subject to the certification 

and recertification process that applies to other organ procurement 

organizations under section 371 of the Public Health Service Act. 

In addition, the bill would require the Diabetes Mellitus Interagency Coordinating Committee, which currently exists, to include 

in its annual report an assessment of federal involvement related 

to pancreatic islet cell transplantation. That assessment would include a discussion of adequacy in funding; current policies, regulations, and procedures related to pancreas procurement and cell 

transplant; policies of the United Network for Organ Sharing regarding pancreas retrieval and cell transplant; existing data collection methods; clinical investigations related to pancreatic islet cell 

transplantation; and any legislative or administrative recommendations that the committee may have. 

CBO estimates that implementing S. 518 would cost less than 

$500,000 in each year over the 2005–2009 period, assuming the 

availability of appropriated funds. Enacting S. 518 would not affect 

direct spending or revenues. 

S. 518 contains no intergovernmental or private-sector mandates 

as defined in the Unfunded Mandates Reform Act and would not 

affect the budgets of state, local, or tribal governments. 

On October 4, 2004, CBO transmitted identical cost estimates for 

H.R. 3858, the Pancreatic Islet Cell Transplantation Act of 2004, 

as ordered reported by the House Committee on Energy and Commerce on September 30, 2004, and S. 2158, the Pancreatic Islet 

Cell Transplantation Act of 2004. The Committee on Health, EduVerDate jul 14 2003 00:52 Oct 15, 2004 Jkt 039010 PO 00000 Frm 00003 Fmt 6659 Sfmt 6602 E:\HR\OC\SR387.XXX SR387
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cation, Labor, and Pensions approved the text of S. 2158 as an 

amendment in the nature of a substitute for S. 518. 

The CBO staff contact for this estimate is Christopher J. 

Topoleski. This estimate was approved by Peter H. Fontaine, Deputy Assistant Director for Budget Analysis. 

VI. REGULATORY IMPACT STATEMENT

The committee has determined that there will be de minimus 

changes in the regulatory burden imposed by the bill. 

VII. APPLICATION OF LAW TO THE LEGISLATIVE BRANCH

Section 102(b)(3) of Public Law 104–1, the Congressional Accountability Act (CAA) requires a description of the application of 

this bill to the legislative branch. This bill does not amend any act 

that applies to the legislative branch. 

VIII. SECTION-BY-SECTION ANALYSIS

Section 1. Short title 

Section 1 names the legislation the Pancreatic Islet Cell Transplantation Act of 2004. 

Section 2. Organ procurement organization certification 

Section 2 amends Section 371 of the Public Health Service Act 

(42 U.S.C. 273) and directs the Center for Medicare and Medicaid 

Services (CMS) to grant ‘‘credit’’ to organ procurement organizations (OPOs)—towards certification and recertification—for 

pancreases procured and used for islet cell transplantation or research. 

Section 3. Annual assessment on pancreatic islet cell transplantation 

Section 3 amends Section 429 of the Public Health Service Act 

(42 U.S.C. 285c–3) to require the Diabetes Mellitus Interagency Coordinating Committee (DIMCC) to conduct an annual assessment 

of federal efforts related to islet transplantation. The legislation requires the DIMCC to evaluate Federal research funding for islet 

transplantation, the effect of specific policies on transplantation, 

data collection, and federal coordination, and make recommendations to the Secretary of HHS. 

IX. CHANGES IN EXISTING LAW

In compliance with rule XXVI paragraph 12 of the Standing 

Rules of the Senate, the following provides a print of the statute 

or the part or section thereof to be amended or replaced (existing 

law proposed to be omitted is enclosed in black brackets, new matter is printed in italic, existing law in which no change is proposed 

is shown in roman):

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PUBLIC HEALTH SERVICE ACT 

* * * * * * *

PART H—ORGAN TRANSPLANTS

ORGAN PROCUREMENT ORGANIZATIONS

SEC. 371. (a)(1) The Secretary may make grants for the planning 

of qualified organ procurement organizations described in subsection (b). 

(Z) * * *

* * * * * * *

(b)(1) A qualified organ procurement organization for which 

grants may be made under subsection (a) is an organization which, 

as determined by the Secretary, will carry out the functions described in paragraph (2) and—

(A) * * *

* * * * * * *

(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). 

* * * * * * *

INTERAGENCY COORDINATING COMMITTEES

SEC. 429. (a) For the purpose of—

(1) better coordination of the research activities of all the national research institutes relating to diabetes mellitus, digestive 

diseases, and kidney, urologic, and hematologic diseases; and 

(2) * * *

* * * * * * *

(c) Each Committee shall prepare an annual report for—

(1) the Secretary; 

(2) * * *

* * * * * * *

(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. 

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(7) Recommendations for such legislation and administrative actions as the Committee considers appropriate to increase the supply 

of pancreases available for islet cell transplantation.

* * * * * * *

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