[Senate Report 108-387]
[From the U.S. Government Publishing Office]



                                                       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

                  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 insulin-independent 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.

              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, Education, 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):

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.
    (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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