[Senate Report 104-256]
[From the U.S. Government Publishing Office]



                                                       Calendar No. 377
104th Congress                                                   Report
                                 SENATE

 2d Session                                                     104-256
_______________________________________________________________________


 
  ORGAN AND BONE MARROW TRANSPLANT PROGRAM REAUTHORIZATION ACT OF 1995
                                _______


                 April 22, 1996.--Ordered to be printed

_______________________________________________________________________

   Mrs. Kassebaum, from the Committee on Labor and Human Resources, 
                        submitted the following
                              R E P O R T
                         [To accompany S. 1324]

    The Committee on Labor and Human Resources, to which was 
referred the bill (S. 1324), to amend the Public Health Service 
Act to revise and extend the solid-organ procurement and 
transplantation programs, and the bone marrow donor program, 
and for other purposes, having considered the same, report 
favorably thereon with an amendment in the nature of a 
substitute and recommend that the bill (as amended) do pass.

                                CONTENTS

                                                                   Page
  I. Summary of the bill..............................................1
 II. Background and need for legislation..............................4
III. Legislative history and committee action.........................9
 IV. Committee views.................................................10
  V. Cost estimate...................................................28
 VI. Regulatory impact statement.....................................33
VII. Section-by-section analysis.....................................33
VIII.Changes in existing law.........................................40


                         I. Summary of the Bill

    S. 1324 extends for 5 years the Solid Organ Transplant 
Program, a program designed to procure and allocate lifesaving 
organs on an equitable basis. The bill phases out funding, 
authorizing $1.9 million for fiscal year 1997, $1.1 million for 
fiscal year 1998, and $250,000 for each of the fiscal years 
1999 through 2001.
    S. 1324 authorizes funds for programs that increase organ 
donation, especially among populations where the need for organ 
donations is greatest. S. 1324 recognizes that, in addition to 
organ procurement, the issue of organ allocation must be 
addressed. Currently, waiting times for organs vary greatly in 
different regions of the country. While a number of studies are 
underway to evaluate 
the present allocation system, this legislation requires organs 
to be distributed on the basis of a single list established in 
an Organ Procurement Organization (OPO) region, a region 
encompassing at least an entire State, an approved alternative 
local unit, or a list that encompasses another allocation 
system which is approved by the Organ Procurement and 
Transplant Network (the Network) and the Secretary of Health 
and Human Services (HHS). The amendments included in this act 
do not interfere with Section 1138 of the Social Security Act, 
which prescribes the relationship between hospitals and OPO's.
    The bill calls for government representation at board and 
committee meetings and greater patient representation on the 
boards of OPO's and the Network and specifies that the general 
public--including patients, transplant candidates, and donor 
families--must comprise a ``reasonable balance'' of each board.
    To protect patients from unreasonable fee increases, the 
Network is required to submit all requests for patient 
registration fee increases to the Secretary of HHS, who is 
given 60 days to disapprove the proposed request. Any increases 
in the patient registration fee shall be limited to an increase 
that is reasonably required as a result of increases in the 
level or cost of contract tasks and other activities related to 
organ procurement and transplantation or decreases in expected 
revenue from patient registration fees available to the 
contractor. Fee increases must be ``reasonable and customary'' 
and may not occur more frequently than once per year.
    The bill also requires OPO's to engage in public education 
about the need for organ donation. S. 1324 requires OPO's to be 
members of the Organ Procurement and Transplantion Network and 
abide by the Network rules.
    S. 1324 authorizes the Secretary to institute and collect a 
``data management fee'' from transplant centers and OPO's, to 
be phased in over the first 3 years. When fully phased in, the 
fee will cover the costs of operating the Scientific Registry. 
The fee will be set by the Network, in consultation with the 
Secretary, and calculated on a per-transplant basis and divided 
in an 80/20 split between the responsible transplant center and 
the OPO.
    In order to track the performance of transplant centers and 
organ procurement organizations, the Network shall submit to 
the Secretary a biennial report which contains center-specific 
data including survival rates, waiting list time, and 
qualifications of transplant physicians and surgeons. Within 1 
year of enactment of S. 1324, the Secretary is required to 
issue a ``final rule'' establishing Network regulations. 
Failure to do so will require the Secretary to issue, within 30 
days of the deadline, a report to Congress describing the 
reasons for failure to comply with the law and steps which are 
being implemented to bring the Department into compliance.
    The Secretary shall withhold annually $250,000, or 10 
percent of the amount of the collected ``data management fee'' 
(whichever amount is larger), to be used to fund contracts to 
increase organ donation. No contract in excess of $25,000 may 
be made, using the above funds, unless an application is 
submitted to the Secretary, recommended by the Network, and 
approved by the Secretary.
    The Secretary through contract shall prepare a triennial 
OPO-specific data report that includes an assessment of the 
effectiveness of OPO's in acquiring available organs. The first 
OPO-specific report should be completed within 18 months of 
enactment.
    Under this bill, the Institute of Medicine (IOM) will 
conduct a two-part study and evaluation including: (1) the role 
and the impact of the Federal Government in the oversight and 
support of solid organ transplantation, the Network (which 
currently carries out its functions by government contract), 
and the solid organ scientific registry of transplant 
recipients registry; and (2) the access of all interested 
constituencies to membership on the Network's board of 
directors and all its committees. Recommendations from the 
second portion of the IOM study are to be considered by the 
contractor in consultation with the Network and the Secretary, 
and a plan for implementation of these recommendations is to be 
developed within 1 year of completion of the study.
    S. 1324 extends for 3 years the Bone Marrow Transplantation 
Program, a program designed to increase the number of unrelated 
marrow donor transplants. The amounts authorized are 
$13,500,000 for fiscal year 1997, $12,150,000 for fiscal year 
1998, and ``such sums as necessary'' for fiscal year 1999.
    The bill clarifies the composition and limits the terms of 
service to three, 2-year terms for the board of directors. 
Composition of the board of directors and the program's 
committees will be composed of a ``reasonable balance'' of 
constituents, including transplant recipients and their 
families.The program's board of directors and committees shall 
include nonvoting representation from the Health Resources and 
Services Administration and the Naval Medical Research and 
Development Command.
    S. 1324 mandates that the National Bone Marrow Donor 
Registry make it a priority to increase the number of 
transplants and potential donors for populations with special 
needs. In addition, the bill requires the contractor to compile 
and distribute informational materials to educate the public 
about the need for potential bone marrow donors and requires a 
compilation and distribution of updates of potential donors. 
The ``Donor Registry'' should be updated annually to account 
for changes in donor status.
    The Bone Marrow Transplant Program, in consultation with 
the Secretary, using the recommendations of the ongoing 
Inspector General study, shall develop and implement, within 1 
year of study completion, a plan to make more efficient the 
relationship between the donor registry and the donor centers. 
The Secretary may enter into contracts with public or nonprofit 
private entities for the purpose of increasing unrelated donor 
marrow transplants through: programs to provide information to 
educate the health community about the availability of 
unrelated marrow transplants; programs to inform the public 
about the need for marrow donations; programs to train 
individuals in requesting marrow donations; and programs to 
recruit, test, and enroll marrow donors--with the primary 
priority being minority populations.
    S. 1324 requires the National Bone Marrow Donor Registry to 
establish and maintain effectively an office of patient 
advocacy and case management, which shall serve as an advocate 
for patients searching for a donor, physicians, and potential 
marrow donors. In addition, the National Bone Marrow Transplant 
Program will provide to constituents a comparison of costs 
incurred by patients prior to marrow transplantation at the 
various transplant centers.
    S. 1324 requires the Institute of Medicine to conduct a 
study that evaluates: (1) the role of a government-supported 
``National Bone Marrow Transplant Program'' in facilitating the 
maximum number of unrelated donor marrow transplants; and (2) 
other possible clinical and scientific uses for the Donor 
Registry's potential donor pool and/or the unrelated marrow 
donor scientific registry.
    In addition, the Secretary shall evaluate the feasibility 
of consolidating all federally funded scientific bone marrow 
transplantation registries (regardless of the type of marrow 
reconstitution). The bill establishes an unrelated marrow donor 
transplant scientific registry to be maintained on all 
recipients of biologically unrelated bone marrow transplants, 
regardless of the method of marrow reconstitution. The Donor 
Registry shall submit an annual report to the Secretary on the 
state of unrelated donor marrow transplantation, using 
information from the scientific registry.

                II. Background and Need for Legislation

                    SOLID ORGAN TRANSPLANT PROGRAMS

    Solid organ transplantation involves the procurement and 
allocation of a scarce resource. This characteristic, coupled 
with the widening gap between supply and demand and the role 
that the Medicare and the Medicaid systems play in the 
financing of organ transplantation ($1.6 billion yearly), 
necessitates a governmental role to maintain equity and to 
decrease the potential for abuse. It is the general view that 
this government-supported system is important, functions 
reasonably well, and provides good value for the dollars 
expended. However, some aspects could be improved. It may be 
important to develop creative and proactive approaches to 
compensate for the anticipated loss of Federal funds while 
maintaining an appropriate level of oversight for the 
government.
     Despite the legislative efforts to increase the organ 
donor pool, the gap between the number of transplants performed 
and the number of organs needed persists. In 1994, a total of 
18,270 organ transplants were performed. As of February 14, 
1996, over 44,000 registrants comprised the waiting list for 
solid organ transplantation, indicating that the demand is more 
than double the supply.

                          LEGISLATIVE HISTORY

    Public demand for organ and tissue transplants led to 
Federal legislation establishing a coordinated network for 
organ sharing and transplantation. Under the National Organ 
Transplant Act (NOTA), P.L. 98-507, Congress consolidated a 
cluster of private organ transplant programs into a federally 
supported entity, the Organ Procurement and Transplantation 
Network (the Network). The overarching objective of the Network 
is to increase the effectiveness of organ donation, 
procurement, and transplantation while ensuring equity to 
patients using the system. NOTA also called for: (1) the 
establishment of a grants program to organ procurement 
organizations (OPO's); (2) a bone marrow transplantation 
demonstration study; (3) the prohibition of human organ sales; 
and (4) a task force to study and make recommendations for 
national organ sharing and immunosuppressive therapy usage.
    The Task Force on Organ Transplantation acknowledged the 
growing gap between the supply of and the demand for organs and 
recommended, among other things, that hospitals and OPO's be 
better coordinated to facilitate organ donation. In response to 
this recommendation, Congress enacted a provision in the 
Omnibus Budget Reconciliation Act of 1986 (P.L. 99-509) 
directing OPO's to utilize policies designed to increase organ 
procurement and directing hospitals to notify OPO's of all 
potential organ donors.
    The Organ Transplant Amendments Act of 1988, Title IV of 
the Health Omnibus Programs Extension of 1988 (P.L. 100-607), 
further addressed widespread concerns about the persistent 
organ shortage. This legislation focused heavily on 
consolidating OPO activities and functions with the aim of 
increasing organ donations. This law reauthorized the Federal 
grants program for OPO's, giving priority to those with special 
projects designed to increase the number of organ donors and 
requiring hospitals to design policies for routinely requesting 
organs from prospective donors and families. To further 
encourage local procurement efforts, this legislation redefined 
OPO service areas, required the Network to develop membership 
criteria for organ allocation, commissioned studies and 
demonstration projects which focused on improving the 
effectiveness of organ donation and allocation, and called for 
the Network to include the public, patients, and their families 
in its decision making. Additionally, this act authorized 
appropriations for the operation of the previously established 
national bone marrow registry for voluntary marrow donors. In 
the Transplant Amendments Act of 1990 (P.L. 101-616), Congress 
directed the General Accounting Office (GAO) to study and 
report on the extent to which organ procurement and allocation 
was equitable, efficient, and effective.

             ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK

    In 1986, the first contract for the federally supported 
Network was awarded to a private organization, the United 
Network for Organ Sharing (UNOS), located in Richmond. The 
Network is an entity supported by a private corporation in 
accordance with Federal organ transplant laws. The Health 
Resources and Services Administration (HRSA) provides oversight 
of the Network. HRSA is responsible for administering the 
Network contract and all of its components including policy 
development, data collection, program monitoring and increasing 
organ donation. Essentially, UNOS is a private contractor 
providing a public service. In that capacity, UNOS is 
responsible for carrying out the functions of the federally 
supported Network within the law. These functions include 
coordinating organ sharing and transplantation, and maintaining 
a patient waiting list. The Federal Government continues to 
provide oversight for this system because of the tensions 
between the supply of and demand for organs.

                ORGAN PROCUREMENT ORGANIZATIONS (OPO's)

    As a member of the Network, OPO's are, by legal definition, 
nonprofit organizations whose staff assist with the organ 
transplant process by screening potential donors, discussing 
donation with family members, arranging for the surgical 
removal of organs, and allocating organs. Federal support for 
OPO's is largely through the the medicare program. OPO's must 
operate within geographical areas designated by HCFA.
    The 1986 Amendments sought to reduce the growing gap 
between organ supply and demand by requiring OPO's to: (1) meet 
organ procurement standards; (2) be members of the Network; and 
(3) comply with allocation rules of the Network.
    The Organ Transplant Amendments of 1988 targeted funding 
for those organ procurement activities that sought to increase 
organ donations. It sought to encourage health care 
professionals to solicit organ donations, thus directing OPO's 
to assist hospitals in developing and implementing routine 
request policies for organ donation. Attempting to improve 
efficiency in the procurement structure and process, the law 
called for streamlining the service areas for OPO's. Also, this 
law required HCFA to define performance standards and do 
effectiveness evaluations for OPO's.
    In response to the continuing organ shortage, the 
Transplant Amendments Act of 1990 (P.L. 101-616) allowed for 
the expansion of grant opportunities to nonprofit 
organizations, other than OPO's, for the purpose of increasing 
organ donations. This legislation also required the GAO to 
report on the extent to which organ procurement and allocation 
was equitable, efficient, and effective.

                            ORGAN ALLOCATION

    Organ allocation has been an item of contention since the 
inception of the federally supported Network. The allocation 
process is controversial, largely because of the variation 
among regions in the level of procurement and the disparity 
between number of donors and size of waiting list. NOTA 
requires that organ allocation be based on ``medical 
criteria.''
    ``Waiting time'' is a composite marker which may be an 
acceptable proxy measure for equity of allocation. There is a 
significant disparity among regions between patients with 
similar medical conditions in ``waiting time'' for organ 
transplantation. Disparity in waiting time is complicated by 
the lack of guidelines and standardization dealing with the 
placement of transplantation candidates onto ``waiting lists.''
    Current law does not specify the types of allocation 
policies the Network are required to adopt, outside of medical 
criteria. The allocation system set forth by the Network is 
currently voluntary pending the development of a ``final rule'' 
by the Secretary. According to a 1993 GAO report, 25 of the 68 
OPO's surveyed did not follow the standard Network guidelines 
for organ allocation although some were operating with approved 
network variances. Changes in Network policy and the behavior 
of the OPO's since the release of the GAO report have resulted 
in improvement, but some variation persists. In September 1994, 
HRSA, responding to a longstanding mandate to develop a ``final 
rule'', released proposed rules and requested comments. Final 
rules have not yet been issued.
    The present system utilizes a single waiting list for each 
OPO. OPO's vary widely in size and geographical configuration 
and may not be the most appropriate allocation unit. The 
present Network contractor, UNOS, has initiated a study to 
model the available liver allocation data and assess the 
outcome of a number of different allocation approaches. The 
University of Pittsburgh has undertaken a similar type of 
predictive analysis. It is expected that this modeling activity 
will result in a new system for allocation of livers by mid-
1996 which should bring further equity to liver allocation. It 
is expected that over the next year, additional modeling 
approaches will be proposed for other solid organs.

                                FUNDING

    Current sources of funding for organ transplant activities 
include the Federal Government (funding for fiscal year 1995 
was $2.6 million) and patient registration fees (of 
approximately $9 million to $10 million per year). Federal 
funds are expended through a distribution of $0.8 million to 
the Network, $1.5 million to the Scientific Registry, and $0.3 
million for donor awareness activities.
    The Network and the Scientific Registry have remained as 
separate contracts, although both are currently held by a 
single contractor, UNOS. Administrative costs for HRSA ($1.4 
million in fiscal year 1995) are covered under the HRSA program 
management fund.
    Recent budgetary constraints have required Congress to 
review the fiscal role of the Federal Government in organ 
transplantation. In the 104th Congress, during consideration of 
the fiscal year 1995 rescission bills, (H.R. 1158 and S. 617), 
both the House and the Senate appropriations committees 
recommended reductions in funding for HRSA's solid organ 
transplant activities. The Senate Committee on Appropriations 
called its action, ``a step toward the phaseout of Federal 
support for this activity,'' and said that alternative sources 
of financing are likely (S.Rept. 104-17). The final version of 
the fiscal year 1995 rescission act did not reduce organ 
transplant funding.

                             ACCOUNTABILITY

    The law requires UNOS to implement policies and regulations 
established by the Secretary for the Network. Currently, a 
board of directors and a total of 11 committees set policies 
and procedures for the Network and also provide similar 
functions for the contractor, UNOS. Neither HRSA nor the Health 
Care Financing Administration (HCFA) are represented on the 
Network board of directors or on its committees. Requirements 
for Federal representation on the board of directors or 
committees are not codified.
    The current transplant system lacks credibility in the eyes 
of some patients, some professionals, and portions of the 
transplant community and public at large. The system is 
criticized for not being responsive to the needs of transplant 
candidates and recipients. Some in the patient community 
believe that it lacks adequate participation and representation 
on the board of directors and committees of the Network. 
Increased participation of the public at large and the ability 
of candidates, recipients, their families, and donor-family 
members to influence the development of policies and procedures 
as voting members of the Network will help to make the system 
more credible and more accountable and could lead to more 
patient-centered policies and procedures.
    Also, the current system lacks consistent patient 
information, advocacy, and involvement in the decision-making 
process. This situation appears to persist despite some efforts 
to correct these deficiencies. There is no standardized set of 
information available or routinely distributed to patients 
which outlines the characteristics of the transplant network, 
the ``waiting lists,'' the organ allocation system, and the 
associated patient rights and responsibilities. This is a 
deficiency which should be addressed.
    Although improved, procurement remains inadequate among 
minority populations. Yet minorities make up a significant 
portion of those individuals with organ failure who could 
benefit from transplants. Increased minority representation on 
the Network may facilitate efforts to improve procurement rates 
among this portion of the population. Additional steps could be 
taken to acquire data from and increase procurement among 
minority populations.

                      BONE MARROW TRANSPLANTATION

    Following years of successful treatments of an array of 
blood-related diseases utilizing allogeneic bone marrow 
transplantation, Congress directed the Department of Health and 
Human Services to hold a conference to determine the 
feasibility of establishing a U.S. national bone marrow donor 
registry. Following this 1985 conference, the Senate Committee 
on Appropriations (S. Rept. 98-636) directed the U.S. Navy to 
establish a national registry of bone marrow donors. In July 
1986, the Navy awarded contracts to a consortium of 
organizations--the American Red Cross, the American Association 
of Blood Banks, and the Council of Community Blood Centers. HHS 
assumed responsibility for the national registry from the Navy 
in fiscal year 1989 (the Navy continues to provide funding to 
the National Marrow Donor Program). The National Bone Marrow 
Donor Registry was formally established in 1990 under P.L. 101-
616. The National Bone Marrow Transplant Program operated under 
the authority of the National Heart, Lung, and Blood Institute 
(NHLBI) of the National Institutes of Health (NIH) until 
October 1994, when it moved to HRSA.
    The 1990 law directed the Secretary to ``increase the 
representation of individuals from racial and ethnic minority 
groups in the pool of potential donors for the registry in 
order to enable an individual in a minority group, to the 
extent practicable, to have a comparable chance of finding a 
suitable unrelated donor as would an individual not in a 
minority group.''
    Toward that end a contract was awarded to the National 
Marrow Donor Program, the contractor, to build a network which 
includes a coordinating center, and independent donor, 
collection and transplant centers. Functions of the NMDP are 
to: (1) collect and maintain a list of potential marrow donors; 
(2) coordinate searches for unrelated marrow donors; (3) 
expedite donor matching, workup, and collection and transport 
of marrow; (4) provide patient advocacy services; and (5) 
assess the outcomes of marrow transplants from unrelated marrow 
donors through maintenance of a scientific registry.
    The National Bone Marrow Transplant Program is a resource 
which currently is being utilized by only a select portion of 
the population. In 1995, 5,300 patients initially searched the 
potential marrow donor pool, with 1025 transplants being 
facilitated. Privatization and or decreases in the budgetary 
support for this program are being discussed. It is believed 
that a strong infrastructure has now been constructed, and that 
efforts should be focused on facilitating more transplants. 
Efforts to assess an appropriate Federal Government role need 
to be undertaken by the bone marrow transplant community and 
the Congress. Given the commitment of resources and the 
development of a national bone marrow donor pool with over 
2,000,000 volunteer donors registered, new uses for this 
registry should be considered for the future.

                                FUNDING

    The NMDP Coordinating Center is an umbrella organization of 
independently operated donor centers, whose relationship to the 
NMDP is contractual. Over $13 million for NMDP Donor Center 
contracts are provided by NMDP patient revenue and the HRSA 
appropriation. The financial viability of some donor centers 
has been questioned. However, most donor centers were started 
prior to the availability of NMDP financial support, by the 
altruism of an individual who had a family member or loved one 
who was in need of a donor. This type of dedication may suggest 
a strong likelihood for donor centers' survival. Restructuring 
of the NMDP could allow it to focus its revenues on those 
centers which are most productive and could also allow it to 
reconsider arrangements with centers which are less costly.
    The NMDP indicates that minority donor recruitment is one 
of its most important goals. Last year, the minority donor pool 
size increased from 218,000 to 311,000 potential donors. Among 
African-Americans, in the period from 1994 to 1995 the donor 
pool rose from 71,000 to 109,000, with 42 transplants performed 
in 1995. In spite of progress being made in minority 
recruitment, insufficient minority donors and transplants 
present a multifactorial problem. The expansion of the donor 
pool size alone is unlikely to correct this problem.

                       MARROW TRANSPLANT RESEARCH

    Biomedical research is the responsibility of the National 
Institutes of Health (NIH), and in 1994 the NIH expended a 
total of $89 million on marrow transplant research. The NMDP 
research dollars ($2 million) are small by comparison. The 
likelihood of duplication of efforts is decreased when there is 
a unified approach.

             III. Legislative History and Committee Action

    Hearings on both the solid organ and the bone marrow 
transplant programs were held before the committee on July 20, 
1995. Testimony focused on the Federal Government's role in the 
oversight and funding of solid organ and unrelated donor marrow 
transplantation. Witnesses representing the Congress, the 
administration, and both professionals and patients from the 
solid organ and bone marrow transplant community presented 
testimony.
    S. 1324 was introduced on October 17, 1995, by Senators 
Kassebaum, Kennedy, and Frist. The bill was referred to the 
Committee on Labor and Human Resources.
    The Committee on Labor and Human Resources considered S. 
1324 in an executive session held on November 8, 1995. Senator 
Kassebaum offered an amendment in the nature of a substitute. 
The bill as amended was unanimously adopted by voice vote and 
ordered favorably reported to the full Senate.

                          IV. Committee Views

    The committee has approached the reauthorization of this 
legislation by an evaluation of the following issues: first, 
does the program provide equity for the program beneficiaries; 
second, is there a necessary government role, and if so, what 
are the proper present and future roles of the government in 
these programs; third, what measures should be taken to make 
the program more efficient and effective; and fourth, what is 
the appropriate Federal funding level for these programs.

                                Title I

                             ORGAN DONATION

    There is an increasing disparity between the number of 
available organs and the number of patients waiting for a 
transplant. More than 40,000 Americans are currently waiting 
for transplants. Improved medical safety and effectiveness of 
organ transplantation have increased the demand for such 
procedures, but efforts to increase the supply of organs have 
not been particularly successful. According to recent figures 
from the industry, the number of organ donors remains 
insufficient. Yet, since 1988, the demand for organs has 
increased by more than 50 percent.
    This legislation acknowledges the need to enhance organ 
donation. Various studies show that between 6,000 and 15,100 
people yearly are potential organ donors, yet only 5,300 
individuals donated their organs in 1995. There is potential 
for increasing the number of organ donors. To increase organ 
donation, the committee has provided authority for the 
Secretary of HHS to make contracts to fund projects to increase 
organ donation, to train health care providers to request organ 
donations, and to provide technical assistance. In addition to 
OPO's and nonprofit organizations, the committee bill would 
make HHS contracts available to other public entities. For 
example, contracts could be given to projects encouraging State 
divisions of motor vehicles to share information with OPO's 
about people who had signed organ donor cards, provided that 
there was no infringement on individual confidentiality. 
Contracts to improve cooperation between OPO's and medical 
examiners is another area where public entities could increase 
organ donation.
    The committee believes that education and technical 
assistance have the potential for increasing the level of organ 
donation. Education campaigns designed to make the public aware 
of the good that can come from transplantation should continue. 
Public opinion surveys show that these campaigns have been 
effective--more than 95 percent of Americans are aware of 
transplantation, and as many as 75 percent say that they would 
be willing to donate an organ after death. What is not 
available in these data are the percentage of individuals who 
have discussed their wishes with relevant family members.
    The low number of procured organs, despite this apparent 
level of public support for donation, led researchers to the 
conclusion that the low procurement rate was due, in part, to 
the failure of health care providers to appropriately request 
donation from families of donor-eligible patients. Various 
early studies seem to support this conclusion. These data, led 
to the development of required request policies. Unfortunately, 
these policies have not resulted in the expected increase in 
the number of procured organs. Recent medical studies showed 
that families of donor-eligible patients are approached about 
organ donation between 73 percent to 87 percent of the time. 
However, only 47 percent of families of eligible donors agree 
to such organ donation. Although health care professionals do 
request that families donate, the rate of consent by families 
has been less than previously assumed. This suggests that 
empirically based education campaigns for health care workers 
could improve their skills in discussing this important issue 
with family members and could potentially increase donation. 
Such training must be augmented with public education focusing 
on the importance of the family discussion. Some success has 
also been found with ``community based'' procurement efforts in 
the New England region.
    Better public education can also help address organ 
donation among populations whose donation rates are lower than 
that of the general population. These populations often face 
longer waiting times and a severe shortage of organs. Since 
there is a higher degree of compatible matching between members 
of the same ethnic group, it is critical that ethnic 
populations donate organs and ensure the availability of organ 
transplantation for these populations. We are pleased to see 
from recent reports a significant increase in minority 
population donation rates.
    The committee believes that an effort should be made to 
categorize organ-donation approaches which have shown promise--
whether developed with Federal funds or otherwise--into a 
central registry and that these approaches should be publicized 
and made available for general use. This registry would allow 
easy access and expedite implementation in other areas of the 
country, if appropriate.
    The committee also expects the Division of Transplantation 
(DOT) in the Health Resources and Services Administration, 
together with the entire transplant community, including 
patient advocate groups, to develop a comprehensive, national 
approach to addressing the need for increased organ 
procurement. The committee believes that, while the small pilot 
projects typically funded through this legislation are 
important to providing communities with the funds to develop 
innovative approaches to the problem, we must take a larger, 
more comprehensive approach to increasing organ donation and 
procurement. The committee expects the funds in this 
legislation that are dedicated to increasing organ donation and 
procurement to be used effectively to maximize the available 
organ donation pool by the year 2001. The committee encourages 
all members of the transplant community to take advantage of 
organ donation approaches that have proven to be effective and 
to implement these approaches more widely.

                    ORGAN PROCUREMENT ORGANIZATIONS

    This act is administered by the Health Resources and 
Services Administration of the Department of Health and Human 
Services. The relationship between hospitals and OPO's is 
directed by the Health Care Financing Administration of the 
Department of Health and Human Services. The dual 
responsibility for organ procurement organizations has posed 
some difficulty in the past. The committee intends to avoid 
discrepancies between agency regulations and legislative 
language. The amendments which are included in this act are not 
to interfere with Section 1138 of the Social Security Act, 
which defines the relationship between hospitals and OPO's. It 
is the committee's expectation that, although OPO performance 
standards are the responsibility of HCFA, HRSA, with its 
responsibility over the transplant Network, will provide the 
oversight of transplant centers and OPO's for organ allocation 
and efforts to increase organ donation. The committee would 
strongly encourage HCFA to consult with HRSA and the DOT in the 
promulgation of performance standards and in the 
recertification and designation of OPO's.
    The committee believes that requiring OPO's to have 
agreements with all hospitals within their service areas which 
have facilities for donation will serve to increase donation, 
which is a major objective of this legislation. However, the 
committee is aware that an OPO has no control over a hospital 
which may choose not to enter into an agreement with the OPO 
serving its area. Likewise, a hospital's reluctance to 
participate may be indicative of a larger issue. The 
committee's intent is that OPO's and hospitals will make every 
effort possible to develop agreements that will ultimately 
increase organ donation.
    The committee is pleased to know that HHS has developed 
primary performance standards for OPO's. Each OPO is expected 
to achieve at least 75 percent of the national mean for four of 
five performance categories, e.g., number of kidneys recovered 
per million population. Most OPO's have demonstrated their 
ability to fulfill these primary performance standards. 
However, OPO's which do not meet these primary standards should 
be given an opportunity to present information about unique 
circumstances in their service areas which impact their ability 
to meet the performance standards. OPO's should be given the 
opportunity to develop and implement a correction plan.
    The committee is concerned that the threshold criterion as 
proposed by HCFA for an entity's eligibility as an OPO is an 
arbitrary qualification standard. Some OPO's are unable to meet 
the 24-donor rule but have demonstrated their ability to meet 
the primary performance standards. Therefore, the committee 
recommends that HHS/HCFA reevaluate the 24-donor rule for 
redesignating OPO's. Placing the major emphasis on OPO 
performance is critical, but it should focus on the primary 
performance measures and those OPO's which fulfill those 
criteria, or effectively demonstrate unique circumstances, 
should be redesignated as in compliance without declaring their 
service areas as open regions. Care should be taken to avoid 
abrupt or inappropriate changes in OPO service area coverages 
which may negatively impact organ donor recoveries.
    The committee recognizes that OPO's are the backbone of the 
organ procurement system. The performance of individual OPO's 
directly affects the well-being of Americans awaiting organ 
transplants. Therefore, this legislation calls for a triennial 
data report by the Secretary assessing the effectiveness of 
individual OPO's in performing their role. The committee 
believes strongly that all OPO's should aim to maximize 
procurement in their service areas and that all OPO's should be 
required to show a plan to improve their performance and report 
the results from those efforts. The committee is sensitive to 
the needs for confidentiality of information. The committee 
does not expect published data to violate the confidentiality 
of patients.
    It is critical to continue to involve transplant 
physicians, surgeons, and transplant centers in the OPO policy-
making process. Fair representation on the OPO board is an 
effective way to accomplish this goal. The committee believes 
that OPO's should use their discretion to determine the optimal 
size of their boards.
    The committee believes that diversification of the board of 
directors is critical to allow the concerns of all members of 
the transplant community to be represented and to create a 
board of directors that is responsive to the needs of the 
public. It is the intent of the committee that the prescribed 
changes in composition of both the board of directors and 
committees of the OPO and the Organ Procurement and Transplant 
Network should represent inclusion which is functional as well 
as numerical. It is the committee's belief that individuals 
should participate in the workings of the OPO's and the Network 
at all levels because of interest and commitment rather than 
because they belong to a specific constituency.

                          ALLOCATION OF ORGANS

    The original intent of the National Organ Transplant Act 
was to assure patients that no matter who they were or where 
they lived, they would have a fair chance of receiving an organ 
transplant. It is the belief of the committee that the United 
States should adopt a consistent and fair system of allocation 
and move away from the persistent fragmentation and 
inconsistency that may have evolved despite the National Organ 
Transplant Act. One obstacle to achieving this consistency has 
been the current variation in organ donation and allocation 
policies. A further problem is that OPO service areas vary 
substantially in size, population, and donation rates. 
Therefore, even if all OPO's followed consistent allocation 
policies within their service areas, patients in one part of 
the country would not be guaranteed the same probability of 
receiving an organ transplant as patients in another OPO.
    The April 1993 GAO report states that OPO allocation 
procedures varied drastically and that different OPO practices 
could account for a portion of the differences in procurement 
and allocation. The same report found that 25 of 68 OPO's did 
not follow Network allocation policies, although some of the 
OPO's had network approved variances. For example, certain 
OPO's used individual transplant center waiting lists rather 
than an OPO-wide list. This practice may result in less-
critically ill patients receiving organs before patients with 
more urgent needs. Moreover, because of the wide variations in 
waiting times across the country, some patients list themselves 
with multiple transplant centers, introducing another level of 
unfairness compared to those patients who are carried only on a 
single list.
    Following the 1993 GAO report, the Network established a 
policy that organs should be allocated using OPO-wide waiting 
lists; any deviation from this policy required approval from 
the Network's board of directors. This policy change has 
resulted in a significant reduction in the use of transplant 
center-specific waiting lists. In 1995 at the request of the 
committee, the GAO reassessed OPO/transplant center waiting 
lists. They have noted in a preliminary report that only three 
OPO's employ transplant center-specific waiting lists. The 
exceptions to this policy, approved by the Network, are based 
on unique characteristics of the OPO, such as geographic size 
and patient demographics.
    The committee believes that the Network should maintain for 
informational purposes a single, nationwide list of persons 
awaiting each type of organ transplant. These lists can provide 
useful information on the number of people waiting for 
transplants and help to assess the equity of different organ 
allocation policies. In order to achieve some degree of 
consistency among and across OPO's concerning organ allocation, 
the committee believes that each OPO should be required, with 
some notable exceptions, to have a single patient list 
encompassing its entire service area. The committee bill 
provides for three types of exceptions: a region consisting of 
at least an entire State; an approved alternative local unit; 
or another allocation system which is approved by the Network 
and the Secretary.
    Waiting times for organs do vary drastically in different 
parts of the country and from one OPO to another. Waiting times 
for kidney transplants range from 85 to 965 days. More than 
half of kidney transplant recipients will wait more than 600 
days before a transplant becomes available. Although patients 
generally wait less time for liver and heart transplants, 
considerable variations in the time that patients wait for 
these organs exist among OPO's. The average waiting list time 
for a liver transplant is 102 days, while the average wait for 
a heart transplant is 219 days. These waits are affected by 
many factors including availability of temporary treatments 
such as kidney dialysis.
    Variations in waiting list times among OPO's may be 
affected by various factors. These factors include among 
others, immunologic donor incompatibility, local transplant 
center characteristics, and local organ recovery. The GAO has 
recently noted that a major factor in determining waiting list 
time is the absence of specific criteria defining the 
appropriate timing for the listing of patients with organ 
failure. The Network is currently involved in crafting listing 
criteria. The committee is supportive of these critical efforts 
and hopes that such efforts will increase patient equity while 
diminishing the tendency of patients to be listed on multiple 
transplant lists.
    This legislation does not prescribe a specific allocation 
approach. There are members of the transplant community who 
have encouraged the Congress to take such action. The committee 
at the present time is unclear as to what is the most equitable 
allocation system. The committee applauds the efforts of the 
transplant community to develop approaches to reevaluate the 
current allocation system. We are hopeful that these efforts 
will go forward and evaluate all relevant solid organ 
transplant allocation systems. The committee believes that 
these efforts must be open and forthright if future allocation 
systems are to be rapidly embraced by the public and the 
transplant community and viewed with a sense of equity and 
fairness.

           ORGAN TRANSPLANT NETWORK AND GOVERNMENT OVERSIGHT

    With passage of the National Organ Transplant Act, the 
Congress set forth a structure which was to be composed of the 
Organ Procurement and Transplant Network, made up of members 
from the transplant community, and the public who would give 
voluntarily of their time and talents. The Network was 
described in the original law as a ``private entity.'' The 
committee views the original designation as a ``private 
entity'' to represent an independent voluntary organization 
which would function outside of a government agency, with 
governmental oversight, and would represent the interests of 
the public and the transplant community. The committee believes 
that the original designation was not a legislative mandate 
that the Network should become a subsidiary of, and therefore 
synonymous with, the Network contractor.
    The Network was given the responsibility for the 
development of policies and procedures for the transplant 
system. The Secretary was vested with the responsibility of 
providing, by contract, for the Network contractor to implement 
the Network policies. The contractor, a not-for-profit, private 
entity, would then function as the implementor of the Network-
developed transplant policies and would be granted the 
authority to function within the constraints of good business 
practices. The Secretary was charged with responsibility for 
oversight of all aspects of the transplant system.
    Over the life of the National Organ Transplant Act, the 
delineation between the Network and the Network contractor has 
been blurred by the integration of these two separate 
structures. At present, the Network and the Network contractor 
share the same committee structure and board of directors. This 
integration has provided some obvious benefits, but it has also 
led to confusion regarding the relative roles of each 
organization. This legislation has been crafted with the 
understanding that this integration already exists and does not 
have to be inherently detrimental. However, the Network 
contractor, by way of the solid organ transplant contract, has 
a monopoly. The integration of the policy-making body (the 
Network) with the Network contractor, and the absence of true 
competition for the contract, allows the Network contractor to 
function in a manner which poses a threat for a conflict of 
interest and could lead to a perception of distrust. It is the 
committee's intent that the language in this legislation 
clarify the relative roles of both the Network and the Network 
contractor.
    This legislation provides for representation of the 
Secretary of HHS through the HRSA Division of Organ 
Transplantation at all meetings of the Network board of 
directors and committees. This representation is to be 
nonvoting. The Secretary, while being allowed representation in 
such meetings, is not expected by the committee to participate 
in all meetings, unless the Secretary believes that such 
attendance is necessary to protect the public good. It is not 
the intent of the committee that the Secretary participate in 
the internal business of the Network contractor. However, 
because the organizational structures of the Network and the 
Network contractor have become integrated, it is the 
committee's intent that the Network will take all steps 
possible to minimize the number of meetings from which the 
Secretary must be excluded.
    There is an increased desire by this committee and, indeed, 
the American people to lift the burden of unnecessary 
government spending and costly, ineffective government 
regulation. However, in the case of organ transplantation and 
donation, it is the committee's belief that the oversight of 
the transplant system represents the management of a unique 
resource, a resource offered by donor families at the moment of 
their greatest tragedy and sorrow. We believe that the actual 
operation of the transplant system should reside in the private 
sector. However, we believe that the elected government of the 
people should, in partnership with the private sector, be the 
ultimate steward of this special gift, thus ensuring that this 
gift is properly cared for, adequately regulated, and 
distributed equally to the maximum extent that is feasible.
    The committee believes strongly that, for the present time, 
it is critical for the government to maintain its role of 
oversight for the solid organ transplant program. The committee 
believes that while the system is more mature than at its 
inception, the inherent concerns regarding the potential for 
abuse and the buying and selling of organs still exists.
    Recent events at a heart transplant program exemplify the 
type of problem that can develop without ``final rules.'' In 
this situation, qualified surgeons departed the transplant 
center without replacements. This action, combined with 
inadequate nursing support, left the center understaffed. 
Despite the manpower difficulties, the program continued to 
enroll new patients. New and existing patients were not told of 
the center's status and difficulties, and hearts for transplant 
were continually rejected for administrative rather than 
patient-specific reasons.
    A performance audit of this problem was conducted by the 
legislative division of the State. Officials of the United 
Network for Organ Sharing (UNOS, the Network contractor), who 
were contacted by these investigators, informed the 
investigators that ``they can't force members (of the Network) 
to comply with their policies.'' However, they said the 
voluntary compliance rate for UNOS policies is very good and 
that peer pressure from other members or from UNOS corrective 
action policies eliminate most noncompliance. The government 
agency responsible for monitoring the transplant program (HRSA) 
was unaware of this problem, although it was reported that the 
government had been excluded from those Network meetings in 
which this issue would have been discussed. The frequency of 
these events is reported by UNOS to be rare, but it is the 
committee's view that the government should not be excluded 
from meetings of this type.
    It is the committee's belief that a portion of the public 
distrust is an indirect result of the failure of the government 
to issue final rules governing the policies and procedures for 
organ transplantation. The absence of final rules provides an 
opportunity for all parties to claim that because the policies 
are voluntary, they are powerless to demand the transplant 
community be responsive to the needs of the public.
    Because of problems of this type and the voluntary nature 
of the present policies, the committee, in this legislation, 
requires the Secretary to issue the final rule which will 
govern the policies and procedures of the organ transplant 
system. The committee believes that because the proposed rule 
was issued on September 8, 1994, and the period of public 
comment has been completed, the Secretary should be able to 
complete the final rule within 1 year of enactment of this 
legislation. The committee also believes that this is critical 
to the maintenance of public trust in the transplant system. 
The committee had considered using the proposed final rule as 
the final rule if the Secretary failed to meet the prescribed 
deadline. However, the committee chose not to pursue this 
course due to concerns that implementing policies as final 
rules which were in force in 1994, without appropriate 
updating, would cause significant upheaval to this dynamic 
system. Nevertheless, the committee believes that it is time 
for the final rule to be issued and that the call for final 
rules, which has spanned more than 6 years, needs to be brought 
to closure. The committee does require the Secretary to report 
to Congress within 30 days of the prescribed deadline if the 
Secretary is not in compliance with this statute. This report 
should explain to Congress why the Secretary is not in 
compliance and what steps are being taken to bring the 
department into compliance at the earliest date possible. The 
``final rule'' is viewed by the committee to be of highest 
priority.
    This legislation has also given the Secretary the 
responsibility to direct and to work with or work through the 
Network contractor to respond to new emerging issues, such as 
those involved in this incident. The committee's intent is that 
a system of prospective surveillance of policy noncompliance, 
the development of criteria and guidelines for the placement of 
patients onto organ-specific transplant waiting lists, and the 
development of user-friendly standardized patient information 
that describes the organ transplant and Network procedures will 
be three of the emerging issues that should be addressed 
immediately.
    The committee believes that the appropriate number, or 
proportion, of members on the board of directors remains an 
issue. The committee believes efforts should be made to appoint 
to the board skilled members of the transplant community who 
would complement the board's responsibilities and improve the 
nonscientific activities (e.g., educational, procurement, 
financial, public relations, legal). The accountability of the 
Network and OPO's to transplant candidates, recipients, and 
families needs to be increased.
    During the course of developing this legislation, the 
committee received a number of communications from patients and 
patient groups urging greater participation by transplant 
recipients, candidates' family members, and members of donor 
families in the policy-making deliberations of the Network. We 
believe the Network contractor has heard these concerns and has 
attempted to increase the involvement of recipients, 
candidates, and family members in its deliberations. However, 
the committee believes that such participation must increase. 
Consequently, language has been included in this bill that 
requires the contractor to assure a reasonable balance of such 
individuals on the committees and board of directors of the 
Network. It is the belief of the committee that the 
deliberations of the Network contractor, in fulfilling the 
requirements of the contract, should be open to the general 
public and that the Network contractor should do everything 
possible to include all interested parties in its operation. 
The committee's intent is for patient representatives to be 
chosen in an open and fair selection process because of their 
interest and commitment and not just because they represent a 
specific transplant center or advocacy group.

                         NEW FUNDING MECHANISM

    The solid organ transplant program has always relied 
heavily on patient registration fees to fund the operation of 
the transplant Network. The collection of a patient 
registration fee predates the enactment of the National Organ 
Transplant Act (NOTA). Currently, more than 75 percent of the 
contractor's revenues comes from patient registration fees; the 
remaining 25 percent comes from Federal appropriations (funding 
for fiscal year 1995 was $2.6 million). The committee 
reconfirms that the patient registration fees are to be used to 
implement the requirements of the solid organ transplant 
contract and other activities related to organ procurement and 
transplantation.
    Currently, the average fee collected totals $325 and goes 
toward maintaining the system and other activities. However, no 
Federal laws or regulations exist governing the collection or 
use of this revenue. A problem could arise if fees were charged 
unfairly.
    The committee is aware of patient concerns that this 
legislation, which provides the authority to the Network to 
establish such fees, could be viewed as a unilateral 
entitlement to raise such fees whenever the contractor deemed 
such increases to be necessary. The committee believes that 
raising the patient registration fee without proper 
justification and input from the patient community is not 
appropriate and should be avoided.
    This legislation allows the Network to propose reasonable 
and customary patient registration fee increases, but these 
requests must be submitted to the Secretary. The Secretary is 
given 60 days to disapprove the proposed fee increase. If the 
Secretary fails to disapprove the proposal as unreasonable, 
then the fee increase will go into effect. Having the Secretary 
participate in the determination of the patient registration 
fee serves to maintain a degree of integrity and fairness in 
charges to patients. The committee's intent is that 
consideration of fee increases receive the highest priority by 
the HHS Secretary, and that requests for increases be carefully 
analyzed so that the public's interest is maintained.
    The committee intends to strengthen Federal oversight of 
the Network, but it is not the committee's intent for the 
Network to be a government entity. Rather the clarification of 
the government's oversight is intended to improve patient 
protection.

                          SCIENTIFIC REGISTRY

    The Scientific Registry is a model for the best in outcome 
data and should continue to be developed and kept current for 
policy making. Data from the solid organ Scientific Registry 
are used for: (1) policy making, especially in the area of 
organ allocation; (2) analysis of transplantation as a 
treatment option for the various types of end stage organ 
failure; (3) reporting on patient and graft survival rates as 
required by the Transplant Amendments of 1990 and as stipulated 
by this legislation; (4) supporting clinical and scientific 
research in areas such as immunogenetics, organ rejection, and 
retransplantation; (5) responding to government and 
nongovernment (e.g., media, academic) data requests; (6) 
providing data to the Health Care Financing Administration for 
the oversight of the Medicare End-stage Renal Disease Program; 
and (7) supplying a source of transplant center-specific data 
which can be used by patients, transplant centers, and third-
party payers in the evaluation of transplant outcomes.
    The Scientific Registry is important to the transplant 
centers. The registry collects and collates data on transplant 
recipients from which the annual, center-to-center comparative 
transplant statistics are generated. This type of outcome data 
is becoming more important as the demand for comparative 
outcome data by patients and managed care corporations 
increases.
    A significant percent of the appropriated funds authorized 
under the National Transplant Organ Act have gone in the past 
to support, through competitive contract, the maintenance and 
expansion of the Scientific Registry. During the 104th 
Congress, the appropriations committees of both the Senate and 
the House of Representatives, in report language for the budget 
rescission and budget resolution legislation, called for the 
development of alternative measures to fund these activities. 
The committee has responded to this request through the 
creation of the ``data management fee,'' an alternative to 
Federal financing.
    The ``data management fee'' is to be levied, on a per-
transplant basis, on transplant centers and the respective OPO. 
The legislation stipulates that the total fee will be divided 
between the transplant center and the OPO in an 80/20 split. 
The fee will be set by the Network but approved and collected 
by the Secretary. It is the committee's intent that the costs 
be maintained at a level adequate to support the maintenance 
and appropriate expansion of the Scientific Registry. The 
committee believes that with approximately 18,000 transplants 
being performed yearly, the one-time, per-transplant fee of 
approximately $100 to $125 would provide adequate revenue to 
support program expenditures. It is the committee's expectation 
that in the case of a living relative donor, the entire data 
management fee would be paid by the transplant center.
    The committee believes that the costs of the ``data 
management fee'' must be kept to a minimum. In an attempt to 
minimize costs to the transplant centers and OPO's, the 
committee intends that the Federal contract for the registry 
must be competitive, and that all high-quality applications be 
given full consideration.
    The committee would like to make clear that the ``data 
management fee'' levied on the transplant centers and 
respective OPOs is not to be an additional charge levied on the 
patients. The committee believes strongly that the fee not 
increase the out-of-pocket costs for transplant patients.
    The prospective implementation of such a ``data management 
fee'' will avoid the disruption of the functions of the 
Scientific Registry, should appropriated funds be rescinded in 
the future. To disrupt the collection of this type of data, 
particularly for the area of organ allocation, would be 
deleterious to the Federal Government, the transplant 
community, and patients who could potentially benefit from a 
transplant.
    This legislation sets aside a small portion of the ``data 
management fee'' to be used to support innovative efforts to 
increase organ donation. These funds, coupled with the funds 
authorized through this legislation, are to be used through the 
collective partnership between the private community and the 
government to increase organ donation. Programs which would 
increase organ donation would be beneficial to all concerned. 
Larger numbers of patients would receive transplants; and with 
more transplants to be performed, more centers' facilities, OPO 
services, physicians, and other health care workers would be 
utilized.
    Funds from the ``data management fee'' to be utilized for 
contracts to support efforts to increase organ donation will be 
administrated by the Secretary, but all contracts which exceed 
$25,000 will require a recommendation by the Network and 
approval by the Secretary before being initiated. It is the 
expectation of the committee that the Secretary, the Network, 
and the patient community work together to encourage the 
effective use of these funds and to assure that all program 
applications for contracts and cooperative agreements be 
evaluated objectively.
    The committee has been very concerned about the continuing 
controversy, over access to Scientific Registry liver 
allocation data, that has existed between UNOS, the Scientific 
Registry contractor, and the University of Pittsburgh Medical 
Center. These events have come about as studies to assess the 
most equitable approach to allocate livers have been under way. 
The committee recognizes the importance of the Scientific 
Registry contractor's obligation to the patients and members to 
maintain the confidentiality of patient-identified data and the 
need to verify center specific data prior to release. However, 
the committee views the Scientific Registry data collected as a 
consequence of administering federally funded contracts to be 
in the public domain and, therefore, as data which should be 
made available to researchers, even if the purpose of the 
research is the development of an alternative allocation 
policy.
    It is the intent of the committee that there be freedom of 
access to the Scientific Registry data, but patient 
confidentiality must be maintained. It is the belief of the 
committee that the Secretary has and must exercise the role as 
final arbiter in such disputes, and the committee believes that 
the contractor must respond to and abide by the final judgment 
of the Secretary on these issues. It is also the committee's 
belief that the transplant community will receive greater 
acceptance of future allocation systems if they are constructed 
in an open and public manner. The transplant community must 
remember that many constituents have a stake in the transplant 
process but that the transplant recipients, candidates, and 
their families are the true consumers of the services of this 
program.

                               THE STUDY

    This legislation requires the Secretary to request the 
Institute of Medicine to conduct a study of (1) the role of and 
the impact of the Federal Government in the oversight and 
support of solid organ transplantation, the Network (which 
carries out its functions by government contract), and the 
solid organ transplantation Scientific Registry; and (2) the 
access of all interested constituencies to membership on the 
Network's board of directors and all its committees.
    The committee is aware of the discussion that is ongoing in 
the transplant community regarding the future direction of this 
program. One faction is of the belief that it is time to 
consider removing the governmental role completely and allowing 
the Network and the Scientific Registry to be privatized. The 
impact of this move at present is purely speculative. The other 
faction is of the belief that the potential inequities that 
existed in the early 1980's which led to the need for the 
initial legislation still exist, and that as long as there is a 
disparity between supply and demand, inequity will exist 
without governmental oversight. It is the hope that this 
proposed study will produce recommendations which will help the 
Congress respond appropriately.
    It is the committee's intent that the group convened by the 
Institute of Medicine to study this issue will be 
representative of the many different factions which make up the 
transplant community, and that the IOM will consider the extent 
and impact on solid organ transplantation of privatizing all or 
a part of the functions and services of the Network.
    The committee has also heard from patient groups, minority 
populations, and other nonphysician, surgeon, and transplant 
center groups regarding what they believe to be inadequate 
``true representation'' on the Network's board of directors and 
committees. It is hoped that with the second component of this 
study, access and true representation will be assessed. It is 
the intent of the committee that within 1 year of completion of 
this report, the contractor, in consultation with the Network, 
will submit to the Secretary and the Congress a plan for 
implementation which would respond to recommendations of this 
report pertaining to access to the transplant policy-making 
organizations.

                    AUTHORIZATION OF APPROPRIATIONS

    It is the committee's intent that the authorization in this 
legislation be a phaseout of funding for the support of the 
Scientific Registry, coordinated with a phase in of the ``data 
management fee.'' The committee believes that the ``data 
management fee'' should be fully implemented by the third year 
after enactment of this legislation.
    The authorization also includes $250,000 each year for the 
direct purpose of supporting innovative national efforts to 
increase organ donation. These funds, coupled with those set 
aside from the ``data management fee,'' should form a major 
effort to increase organ donation.

                                Title II

    The National Bone Marrow Transplant Program was developed 
to maximize and facilitate the number of unrelated donor bone 
marrow transplants. This program was separated from solid organ 
transplantation because marrow transplantation is quite 
different from solid organ transplantation. The harvest and 
transplantation of bone marrow is a much more controlled 
process. While the need for a marrow transplant can be 
emergent, it seldom includes the unpredictability that is 
inherent in a solid organ transplant.
    Marrow transplantation is now used as treatment for many 
illnesses. Marrow transplants are of two types: autologous and 
allogeneic.
    Autologous transplants are the most frequently performed 
type of marrow transplant and are associated with fewer 
complications than are allogeneic transplants. Autologous 
transplants use the patient's own bone marrow; therefore, 
finding an identical donor match is unnecessary.
    Allogeneic transplants rely on a related or unrelated 
marrow donor. Unfortunately, only 25 percent of patients will 
have an acceptable living related donor. Careful matching of 
the donor and recipient is critical for success in allogeneic 
marrow transplants, and for those patients without a related 
donor, an unrelated donor must then be sought.
    In this country, approximately 21,000 bone marrow 
transplants are performed yearly. About 13,000 transplants will 
utilize the patient's own bone marrow for transplant 
(autologous transplant), while the remaining 8,000 transplants 
use bone marrow from related or unrelated donors (allogeneic 
transplant). The National Bone Transplant Marrow Program is 
involved in only those allogeneic transplants in which an 
unrelated donor marrow is used.
    The National Bone Marrow Transplant Program has facilitated 
4,135 transplants since its inception. The yearly total has 
increased from 554 transplants in 1992 to 840 in 1994. The 
National Marrow Donor Program facilitated 1025 transplants in 
1995. This increase in transplants has occurred at a time when 
the donor pool has increased from 711,696 to over 2 million. 
The General Accounting Office concluded in their 1992 report 
(``Bone Marrow Transplants: National Program Has Greatly 
Increased Pool of Potential Donors,'' GAO/HRD-93-11) that the 
program had been very successful in recruiting potential 
donors, but the success in facilitating unrelated donor marrow 
transplants has been more modest.
    The National Marrow Donor Program had an annual budget of 
$63.0 million in 1995. This funding came from patient fees, a 
contract with the Department of Defense (Navy), and the Public 
Health Service authorization. Public Health Service funds are 
expended by the program primarily for donor center contracts, 
minority recruitment efforts, bone marrow transplant research, 
and administrative costs. Appropriated funds are used to 
support the infrastructure needed to facilitate the search for 
unrelated donor marrow. However, there are no Federal dollars 
in this authorization which support individual patient marrow 
transplants.
    The contractor has expanded its focus in recent years to 
include the areas of patient advocacy, minority donor 
recruitment, marrow procurement and storage standards, and bone 
marrow transplant research. This legislation intends to codify 
a number of the measures which the contractor has implemented 
during the past 2 years. The foundation for this 
reauthorization legislation is that of Senate bill 1994, which 
was passed by the Senate in the 103rd Congress.

                    UNRELATED MARROW DONOR REGISTRY

    It is the committee's intent that this program's primary 
priority must be to facilitate and maximize the number of 
unrelated donor marrow transplants. The committee believes 
that, in the past, the primary focus of this program has been 
to increase potential marrow donors. While this has been a 
laudable goal, it must be stressed that unlike the case for 
solid organ transplantation, recruitment of a marrow donor does 
not automatically translate into a marrow transplant because of 
the need for matching.
    Certain populations have been underrepresented within the 
potential donor pool and also among the individuals who undergo 
transplantation. A prime example of this problem is the 
transplantation of African-Americans. In 1992, only 16 African-
American transplants were performed. The potential donor pool 
has been increased by almost 400 percent, yet the number of 
transplants per year increased to only 25. The committee 
believes that the program must target certain populations to 
increase the number of potential marrow donors, but it also 
believes that increasing the number of potential donors is only 
a portion of the answer to unrelated donor marrow 
transplantation. Barriers such as the need for donor-recipient 
matching, patient and physician education, genetic 
heterogeneity, cultural differences, and financial issues must 
also be overcome before unrelated donor marrow transplantation 
can be more universally available. The committee does not 
believe that the National Bone Marrow Transplant Program alone 
can resolve most of these latter factors.
    The committee is concerned about the arrangements that the 
contractor has developed with the donor centers. It is the 
committee's belief that these arrangements have been expensive 
and may not have been structured in as cost-effective way as 
possible. The committee has also been informed that donor lists 
may not be updated on a regular basis and that individual 
donors may be listed on more than one donor center roster. The 
committee believes that this leads to increased cost and offers 
little benefit to patients seeking an acceptable marrow donor. 
The committee is very supportive of the ongoing Inspector 
General's study, ``Bone Marrow Program Inspection,'' and hopes 
that recommendations from this study can be implemented to 
improve the present program-donor center contractual 
relationships.
     It is the committee's intent that donor centers be 
retained within the program based on performance and not merely 
because of a historical relationship. The donor registry should 
undergo periodic review, with removal of potential donors that 
are no longer viable. The committee believes that with a 
substantive restructuring of the program-donor center 
relationship, program services can be maintained, while 
decreasing expenditures for the donor center contracts.

                  PATIENT ADVOCACY AND CASE MANAGEMENT

    The committee intends with this legislation to strengthen 
the patient advocacy responsibilities of the National Bone 
Marrow Donor Registry in several respects. One of these is the 
explicit requirement that the patient advocacy program include 
case-management services for potential marrow donors and 
recipients. The committee is aware that the program contractor 
has established an office of patient advocacy and has formed a 
patient services committee that meets regularly. The committee 
looks forward to completion of the study now under way, by the 
Secretary, to assess these functions. The committee intends 
those recommendations to be seriously considered, with 
implementation of those suggestions which would improve such 
functions.
    The committee believes that to achieve its mission fully, 
the program must be attentive not only to the needs and 
concerns of donors, potential and actual, but also to those of 
patients in need of a marrow transplant. The most significant 
contribution the program can make to a patient is to facilitate 
a successful marrow transplant. It is essential that, once a 
patient has been identified as a candidate, or potential 
candidate, for marrow transplantation, he or she receive 
individualized guidance, support, and assistance in fully 
understanding and utilizing the resources of the entire marrow 
transplant system. The policies and procedures of this system 
can seem complex and confusing, particularly to patients and 
families facing the pressures and anxieties that come with a 
fatal disease.
    The principal elements of such a case-management approach 
should, in the committee's view, include at least the 
following: prompt and accurate information provided to the 
individual patient about the process and how to obtain access 
to the various resources available; periodic communications 
with the patient and families as well as the physician at each 
significant stage in the search process to make sure the 
patient has complete information about the status of the search 
and to determine whether the patient's needs and concerns are 
being met; monitoring of the search process and troubleshooting 
any problems or delays; assistance with questions about fees, 
insurance coverage, or program eligibility; and removal of any 
barriers to communications that might arise between the patient 
and the other participants in the transplant system.
    The contractor must continue to assure that these services 
are being provided. It may do so through a combination of 
services furnished by the Office of Patient Advocacy and 
services furnished by a network of trained and competent 
individuals located at each transplant center. The committee 
believes that the program is to be held accountable for 
providing training and guidance to such individuals, for 
monitoring their performance, and for being prepared to 
intervene in individual cases where serious concerns arise with 
respect to the search process. In addition, physicians should 
be encouraged, supported, and assisted to serve as advocates on 
behalf of their patients. The patient, family, and physicians 
must know there is always a responsible person to whom they may 
turn whenever a problem arises.
    Potential and real donors are individuals who give of 
themselves in an unselfish manner by providing a marrow 
donation to an unrelated but matched recipient. Donors are 
individuals who, prior to being found to be acceptable matched 
marrow donors, are not included in the health care system. They 
are then thrust into the system, and after a medical evaluation 
they are expected to submit themselves to a surgical procedure 
for the harvesting of the marrow donation gift. The completion 
of this procedure leaves the donor in a position without 
specific advocacy. Donors must be provided with donor advocacy 
and individual case management for services such as a leave of 
absence from place of employment, medical care for any initial 
or post-procedure residual physical complaints, and monitoring 
the donor's resumption to their pre-donation life style.

                   NATIONAL BONE MARROW DONOR PROGRAM

    The committee has been concerned that, in the past, the 
National Marrow Donor Program has practiced a policy of 
routinely reappointing rather than alternating membership on 
its board of directors. While the committee applauds the 
changes to its policies of board membership recently made by 
the program contractor, the committee believes that it is 
important for the boards to be further diversified and to bring 
new members with varying points of view to the board and 
committees.
    Members of the board of directors will have a term of 
office of 2 years, with a limit of three terms of service. The 
board of directors and the committees will be composed of a 
``reasonable balance'' of constituents, including recipients 
and their families. The committee's intent is that there also 
be nonvoting representation from the Health Resources and 
Services Administration and the Naval Medical Research and 
Development Command on the board of directors and committees, 
as the Secretary of HHS deems it to be appropriate. The 
committee believes that all members of the bone marrow 
transplantation community, including the public, should be 
represented in the policy-making process of this program.

         UNRELATED DONOR MARROW TRANSPLANT SCIENTIFIC REGISTRY

    The committee intends that the NMDP continue to maintain 
the unrelated donor marrow Scientific Registry. This Scientific 
Registry should include information on all recipients of 
biologically unrelated bone marrow transplants, regardless of 
the method of marrow reconstitution. The committee's intent is 
that this scientific registry contain information including the 
recipient and donor demographics, characteristics of the 
transplant preparative regimen, and outcome data.
    The National Bone Marrow Donor Registry contractor shall 
submit an annual report to the Secretary of HHS on the state of 
unrelated donor marrow transplantation, using information from 
the Scientific Registry. It is the intent of the committee that 
this registry provide public information and that within the 
confines of maintenance of patient confidentiality, this 
information be made available to the biomedical scientific 
community for use in furthering medical science.

                        STUDIES AND EVALUATIONS

    The committee is interested in receiving recommendations 
from the bone marrow transplant community on the future role of 
the Federal Government in the area of unrelated donor marrow. 
The committee is proud of the infrastructure which has been 
built through the partnership between private efforts and 
governmental support. The success of the program to date is a 
testimony to the strength and credibility of the infrastructure 
that has been developed. It is also the committee's belief that 
the National Bone Marrow Transplant Program contractor has 
performed well in the delivery of the important services to 
program beneficiaries and has responded to the emerging needs 
of the transplant community.
     The committee is aware of the findings of the General 
Accounting Office's 1992 report ``Bone Marrow Transplants: 
National Program Has Greatly Increased the Pool of Potential 
Donors,'' GAO/HRD-93-11). Noting these conclusions, it is the 
intent of the committee that the proposed Institute of Medicine 
study focus primarily on issues which are global in nature and 
programmatic and not on the performance of the contractor.
    Debate exists about the appropriate governmental role in 
many of the national programs that receive governmental 
support, including the National Bone Marrow Transplant Program. 
The need for a matched donor for an individual with an illness 
which may be responsive to allogeneic marrow transplant is 
obviously critical, but members of the committee believe that 
the benefits to the Nation as a whole of this government-
supported program need to be evaluated. The question which the 
committee has considered is: With the infrastructure now in 
place, would a change in the Federal Government's role have a 
positive or negative effect on the delivery of potentially 
lifesaving marrow transplant services to those patients in 
need?
    The committee expects the Secretary of HHS to request the 
Institute of Medicine to conduct a study to evaluate the role 
of a government-supported National Bone Marrow Transplant 
Program in facilitating the maximum number of unrelated marrow 
donor transplants. The committee believes this study should 
consider the magnitude of the potential need for unrelated 
marrow transplants that are reasonably feasible based on the 
present state of the art of patient-donor matching, the optimal 
potential donor pool size that would maximize the number of 
unrelated donor marrow transplants, the dependence of donor 
centers on the financial support provided to them through the 
HRSA appropriation, and other potential uses of the large 
registry of Human Leukocyte Antigen (HLA) matched marrow 
donors. It is also the committee's intent that the Institute of 
Medicine assess the present and future optimum capacity of the 
National Bone Marrow Program to provide equity of opportunity 
for finding matched unrelated donors for all ethnic groups. The 
optimal balance between the expected numbers of facilitated 
unrelated transplants, donor pool size and the HLA diversity of 
potential donors and the population should be considered. For 
the purposes of the IOM study, an optimum number of transplants 
facilitated by the National Bone Marrow Program is a number 
that can be reasonably achieved among all racial groups and 
among diverse HLA types given the present state of patient-
donor matching, the diversity of HLA types among the population 
and potential rates of increase in potential donor pool size 
and racial diversity.
    The committee expects the Institute of Medicine to use the 
expertise of the marrow transplant community in developing the 
recommendations of this study. The committee believes that in 
defining the marrow transplant community, the Institute of 
Medicine should include not only scientists, but also marrow 
transplant physicians, transplant and donor center 
representatives, unrelated donor marrow transplant recipients 
and their families, and the appropriate research community.
     The committee believes that a study which examines need, 
scientific and technology limitations of unrelated donor marrow 
transplantation, other potential uses of such a large registry 
of HLA-typed donors, and the present limit on Federal 
Government resources would produce recommendations to Congress 
which could help define the future role for the government in 
this program. It is the hope of the committee that this study 
will also provide for the program contractor a blueprint of 
options that could be considered for the future.

                           OTHER EVALUATIONS

    The committee also intends for the Secretary of HHS to 
conduct an evaluation of the feasibility of consolidating all 
federally funded bone marrow transplant scientific registries. 
The committee believes that the consolidation of these 
registries would make this information both clinically and 
scientifically more valuable. The committee anticipates that 
the consolidated scientific registry data will become the 
foundation for the development of transplant policies and 
procedures, while helping to chart the future of marrow 
transplantation.
    The Federal Government currently funds the unrelated donor 
marrow transplant Scientific Registry as part of the National 
Bone Marrow Transplant Program, the International Bone Marrow 
Transplant Registry, the Autologous Bone Marrow Transplant 
Registry, and the soon-to-be-funded Scientific Registry to 
track marrow reconstitution with the use of umbilical cord 
blood cells. These data could then be used to develop policies 
and procedures to chart the future of marrow transplantation.
    The committee remains committed to the importance of 
biomedical research. The committee expects the Secretary to 
conduct an evaluation of the feasibility of consolidating all 
federally funded bone marrow research under the direction of 
the National Institutes of Health.
    The Federal Government through the National Institutes of 
Health provided more than $110 million for bone marrow research 
in fiscal year 1995. The committee does not intend for the 
National Bone Marrow Transplant Program to administer and 
direct an independent marrow transplant research program which 
has the potential to be duplicative of other government-funded 
bone marrow efforts. While the committee is not opposed the 
National Bone Marrow Transplant Program developing a research 
presence, the committee believes that the National Bone Marrow 
Transplant Program should compete through the peer-reviewed 
system of the National Institutes of Health.

                    AUTHORIZATION OF APPROPRIATIONS

    The committee has decreased the authorized funding for this 
program during the first 2 years of this legislation. The 
committee believes that the decrease in funding is quite modest 
(approximately 10 percent of authorization or 2.5 percent of 
the program's total budget) and is consistent with the amount 
of funding which the program has devoted to bone marrow 
transplant research. Because the decrease in authorization is 
modest, the committee intends for the level of services for 
program beneficiaries, including the funds devoted to increase 
minority transplants, to be maintained at the present level.
    The legislation authorizes funding in the third year at a 
level of ``such sums as necessary.'' The committee intends with 
this authorization to allow for the recommendations of the 
Institute of Medicine study to be evaluated for possible 
implementation.

                            V. Cost Estimate

                                     U.S. Congress,
                               Congressional Budget Office,
                                    Washington, DC, March 14, 1996.
Hon. Nancy Landon Kassebaum,
Chairman, Committee on Labor and Human Resources,
U.S. Senate, Washington, DC.
    Dear Madam Chairman: The Congressional Budget Office has 
reviewed S. 1324, the Organ and Bone Marrow Transplant Program 
Reauthorization Act of 1995, as ordered reported by the Senate 
Committee on Labor and Human Resources on November 8, 1995.
    The bill would affect direct spending and receipts and 
therefore would be subject to the pay-as-you-go procedures of 
the Balanced Budget Act.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Cyndi S. 
Dudzinski.
            Sincerely,
                                           June E. O'Neill,
                                                          Director.

               CONGRESSIONAL BUDGET OFFICE COST ESTIMATE

    1. Bill number: S. 1324.
    2. Bill title: Organ and Bone Marrow Transplant Program 
Reauthorization Act of 1995.
    3. Bill status: As ordered reported by the Senate Committee 
on Labor and Human Resources on November 8, 1995.
    4. Bill purpose: S. 1324 would reauthorize the Solid Organ 
Transplant Program and the Bone Barrow Transplantation Program. 
It would modify the programs to improve public information and 
access to their services, increase participation of those 
directly affected by the programs, and require evaluative 
studies and reports. In addition, the bill would permit the 
Secretary of Health and Human Service and the Organ Procurement 
and Transplantation Network to collect fees to cover the costs 
of providing certain services in the Solid Organ Transplant 
Program.
    5. Estimated cost to the Federal Government: For the Solid 
Organ Transplant Program, the bill would authorize $1.95 
million for 1997, $1.1 million for 1998, and $0.25 million each 
year from 1999 through 2001. For the Bone Barrow 
Transplantation Program, it would be authorize $13.5 million 
for 1997, $12.15 million for 1998, and such sums as may be 
necessary for 1999. For the purpose of this estimate, CBO 
assumes that all funds authorized by the bill would be 
appropriated. Since the bill does not contain any authorization 
for fiscal year 1996, the spending shown for that year reflects 
only the amounts appropriated in the continuing resolutions 
through March 15, 1996. Estimated outlays are based on 
historical spending patterns of existing programs administered 
by the Health Resources and Services Administration (HRSA).
    The bill would also continue the patient registration fee, 
establish a data management fee, and authorize the spending of 
their proceeds without further Congressional action. These 
provisions would increase offsetting receipts and direct 
spending but have no significant effect on total outlays.
    The following table summarizes the estimated authorizations 
and outlays that would result from S. 1324 under two different 
sets of assumptions. The first set of assumptions adjusts the 
estimated authorizations for projected inflation after 1996. 
The second set of assumptions makes no allowance for projected 
inflation.

----------------------------------------------------------------------------------------------------------------
                                                        1995      1996      1997      1998      1999      2000  
----------------------------------------------------------------------------------------------------------------
                                        AUTHORIZATIONS OF APPROPRIATIONS                                        
                                                                                                                
Spending under current law:                                                                                     
    Budget authority................................      18.0       7.6  ........  ........  ........  ........
    Estimated outlays...............................      16.4      12.5       5.1       0.8  ........  ........
                                                                                                                
                                          WITH ADJUSTMENT FOR INFLATION                                         
                                                                                                                
Proposed changes:                                                                                               
    Estimated Authorization.........................  ........  ........      15.5      13.3      12.8       0.3
    Estimated outlays...............................  ........  ........       7.4      12.7      13.3       6.8
Projected spending under S. 1324:                                                                               
    Estimated Authorization.........................  ........  ........      15.5      13.3      12.8       0.3
    Estimated outlays...............................  ........  ........      12.5      13.5      13.3       6.8
                                                                                                                
                                        WITHOUT ADJUSTMENT FOR INFLATION                                        
                                                                                                                
Proposed changes:                                                                                               
    Estimated Authorization.........................  ........  ........      15.5      13.3      12.4       0.3
    Estimated outlays...............................  ........  ........       7.4      12.7      13.1       6.7
Projected spending under S. 1324:                                                                               
    Estimated Authorization.........................  ........  ........      15.5      13.3      12.4       0.3
    Estimated outlays...............................  ........  ........      12.5      13.5      13.1       6.7
                                                                                                                
                                                 DIRECT SPENDING                                                
                                                                                                                
Total...............................................  ........  ........     (\1\)     (\1\)     (\1\)    (\1\) 
----------------------------------------------------------------------------------------------------------------
\1\ Less than $500,000.                                                                                         

    The costs of this bill fall within budget function 550.
    6. Basis of the estimate: The Organ Procurement and 
Transplantation Program provides funds to support the National 
Organ Procurement and Transplantation Network (Network). The 
Network is an organization established by the Federal 
Government to maintain a 24-hour telephone service that aids in 
matching donor organs with potential recipients and in 
coordinating placement efforts with transplant centers. The 
program also funds the Scientific Registry of Transplant 
Recipients (Scientific Registry). The Scientific Registry 
provides information on transplant recipients and outcomes of 
organ transplants which may be used for research and policy 
making.
    The National Bone Marrow Donor Program provides funds to 
support the National Bone Marrow Donor Registry (Donor 
Registry). The Donor Registry maintains a list of potential 
bone marrow donors and matches patients in need of a transplant 
with a biologically unrelated donor of the same issue type. 
This registry increases the chances of a patient without a 
suitably matched relative to receive a transplant. The Health 
Resources and Services Administration has authority over the 
Donor Registry to allow for coordination between the solid 
organ and bone marrow transplantation programs.

Solid Organ Transplant Program

    S. 1324 would permit the Secretary to enter into 
cooperative agreements and contracts for the purpose of 
increasing organ donation through approaches such as planning 
and conducting educational programs for the public, training 
individuals in requesting organ donations from the public, 
providing technical assistance to entities that can contribute 
to organ donation, and increasing organ donation and access to 
transplantation for populations experiencing organ shortages.
    The bill would require organ procurement organizations 
(OPO's) to conduct and participate in systematic efforts to 
increase the number of potential donors, including populations 
for which there is a greater degree of organ shortage than that 
of the general population. OPO's would have agreements with all 
of the health care entities with facilities for organ donation 
in their service areas to identify potential organ donors.
    In addition, OPO's would allocate donated organs on the 
basis of lists that identify individuals medically referred to 
a transplant center in their service areas and who are on a 
waiting list for that organ. The list would encompass an entire 
service area, an entire state, an approved alternative local 
unit, or another allocation system that has been approved by 
the Network and the Secretary. The bill would also require 
OPO's to be members of the Network and abide by its rules and 
requirements.
    Finally, S. 1324 would require the Board of Directors for 
the Network and the Boards of Directors for qualified OPO's to 
be composed of a reasonable balance of constituents, including 
transplant recipients, members of their families, medical 
providers, and others directly involved in providing organ 
transplant services.
    Fees.--S. 1324 would permit the Network to continue 
assessing a patient registration fee for listing potential 
transplant recipients on its national organ matching system to 
cover the reasonable costs of operation. The proceeds of this 
fee could be spent without further Congressional action. Fee 
increases, however, would require approval by the Secretary, 
and spending would be subject to an annual audit.
    The bill also would permit the Secretary to collect a new 
data management fee from transplant hospitals and OPO's. This 
fee would cover the costs of the operation and administration 
of the Scientific Registry and the costs of contracts and 
cooperative agreements that support efforts to increase organ 
donation. The data management fee would be set annually by the 
Network based on the number of transplants performed. CBO 
estimates that these fees would be about $1.8 million in 1997. 
The transplant center would pay 80 percent of the fee, and the 
OPO would pay the remaining 20 percent. Again, the proceeds 
from this fee could be spent without further Congressional 
action, but the expenditure of such funds would be subject to 
an annual audit.
    The Secretary would annually withhold the larger of 
$250,000 or 10 percent of the receipts from the data management 
fee to be used to fund the contracts with qualified OPO's and 
other public or nonprofit private entities to increase organ 
donation. No contract in excess of $25,000 would be made unless 
approved by the Secretary.
    Studies and Reports.--S. 1324 would require the Secretary 
to issue a final rule to establish the regulations for criteria 
under the Solid Organ Transplant Program within 1 year of the 
enactment of this act.
    The Public Health Service would be directed to contract for 
a triennial report on each organ procurement organization that 
would include: information on the effectiveness of each OPO in 
acquiring potentially available organs, particularly among 
minority populations; data on the variation of procurement 
across hospitals within the OPO's region; a plan to increase 
procurement, particularly among populations for which there is 
a greater degree of organ shortage relative to the general 
population; and a plan to increase procurement at hospitals 
with low rates of procurement.
    The Network would submit to the Secretary an annual report 
concerning the scientific and clinical status of organ donation 
and transplantation.
    The bill also would require the Institute of Medicine to 
study the role and impact of the Federal Government in the 
oversight and support of solid organ transplantation. This 
study would be completed within 2 years after the date of 
enactment of this proposal.

Bone Marrow Transplant Program

    S. 1324 specifies that the recruitment efforts for 
potential bone marrow donors would include the priority to 
increase potential marrow donors for which there is a greater 
degree of marrow donor shortage than that of the general 
population and the compilation and distribution of 
informational materials to educate and update potential donors.
    The bill would permit the Secretary to enter into contracts 
with entities for the purpose of increasing unrelated 
allogeneic marrow transplants. This would enable such entities 
to: provide information and education on the availability of 
such transplants as a potential treatment option; provide 
information and education to the public on their availability 
and the need for donations of bone marrow; train individuals in 
requesting bone marrrow donations; and recruit, test, and 
enroll marrow donors with the priority being groups for which 
there is a great degree of marrow donor shortage than that of 
the general population.
    It would require the Donor Registry to provide information 
to physicians, other health care professionals, and the public 
regarding the availability of unrelated allogeneic marrow 
transplantation as a potential treatment option.
    The Donor Registry would establish and maintain an office 
of patient advocacy and case management to assist patients and 
their physicians in a search for an unrelated donor and provide 
services as appropriate to assist individuals and physicians 
involved with the Donor Registry. The office would also collect 
and analyze data and perform patient surveys. The bill would 
require the Donor Registry to be updated annually to account 
for changes in potential donor status.
    Finally, S. 1324 would require the board of directors of 
the Donor Registry and its committees to be composed of a 
reasonable balance of constituents including transplant 
recipients, members of their families, medical providers, and 
others directly involved in providing bone marrow transplant 
services.
    Bone Marrow Scientific Registry.--S. 1324 would require the 
Secretary to establish and maintain a bone marrow scientific 
registry of all recipients of biologic unrelated allogeneic 
marrow donors. It would include information on these transplant 
recipients, transplant procedures, pre-transplant and 
transplant costs, and other information the Secretary 
determined to be necessary for evaluation of the scientific and 
clinical status of unrelated allogeneic marrow transplantation.
    Studies and Reports.--S. 1324 would require the Institute 
of Medicine (IOM) to study the role of a national bone marrow 
transplant program supported by the Federal Government in 
facilitating the maximum number of unrelated marrow donor 
transplants. The IOM would also be directed to study other 
possible clinical or scientific uses of the potential donor 
pool or the accompanying information maintained by the Donor 
Registry or the unrelated marrow donor scientific registry. 
This study would be completed within two years after the date 
of enactment of the bill.
    The bill would require the Secretary to evaluate the 
feasibility of integrating or consolidating all federally 
funded bone marrow transplantation scientific registries, 
regardless of the type of marrow reconstitution used. It would 
also require the Secretary to evaluate all federally funded 
bone marrow transplantation research to be conducted under the 
direction and administration of the peer review system of the 
National Institutes of Health.
    Finally, within one year of the completion of the Bone 
Marrow Donor Inspection, performed by the Inspector General, 
the bill would require the marrow donor program to develop, 
evaluate, and implement a plan to streamline and make more 
efficient the relationship between the Donor Registry and donor 
centers based on the recommendations of the study.
    7. Estimated cost to State and local governments: S. 1324 
would impose a mandate on public hospitals with transplant 
centers by requiring them to pay a data management fee 
(discussed in section 6 of the cost estimate). In total, we 
expect that $1.8 million would be collected each year from this 
fee. Because payments from public hospitals would represent a 
small percentage of these fees, the costs of complying with 
this mandate would not exceed the $50 million threshold. The 
bill would impose no other direct costs on state and local 
governments.
    8. Estimated costs to the private sector: Title I, section 
103, would impose two mandates on private sector entities. The 
patient registration fee (which the Network already collects) 
would impose costs on potential transplant recipients, and the 
new data management fee would impose costs on organ procurement 
organizations (OPO's) and transplant centers.
    With respect to the patient registration fee, the bill 
would continue current practice. The Network already collects a 
one-time patient registration fee of $315, intended to cover 
its listing costs. In 1995, collections from this fee totaled 
about $10 million. The bill would not increase the costs of the 
private sector compared to the costs of carrying out Federal 
laws and regulations currently in effect.
    The estimated cost of the newly imposed data management fee 
would be $1.8 million per year. Because part of the fee would 
be paid by public hospitals (who are not in the private 
sector), the cost of this mandate to private-sector entities 
would be somewhat less than $1.8 million per year.
    9. Estimate comparison: None.
    10. Previous estimate: None.
    11. Estimate prepared by: Cyndi S. Dudzinski, Marc Nicole, 
Sandra Christensen.
    12. Estimate approved by: Paul N. Van de Water, Assistant 
Director for Budget Analysis.

                    VI. Regulatory Impact Statement

    The committee has determined that there will be no increase 
in the regulatory burden of paperwork as the result of this 
bill.

                    VII. Section-by-Section Analysis

                Title I--Solid-Organ Transplant Program

    Section 101 of the bill cites the short title as the 
``Solid-Organ Transplantation Program Act of 1995.''
    Section 102(a) of the bill amends section 371(a) of the 
Public Health Service Act (Organ Procurement Organizations) to 
authorize the Secretary of the Department of Health and Human 
Services (HHS) to enter into agreements or contracts with organ 
procurement organizations (OPO's) for the purpose of increasing 
organ donations through activities that include the following:
    (a) planning and conducting programs designed to educate 
the public about the need for organ donations;
    (b) training for individuals to request organ donations;
    (c) providing technical assistance to OPO's and other 
groups that can contribute to organ donations;
    (d) support for research and demonstration programs 
designed to increase organ donations;
    (e) voluntary consolidation of OPO's and tissue banks; or
    (f) increasing organ donation and access to transplantation 
among minority populations for which there is a greater degree 
of organ shortages relative to the general population. Under 
the new section 371, the Secretary shall give priority to 
increasing donations and improving consent rates among 
prospective donors as well as increasing donations from both 
OPO's and hospitals.
    For purposes of this act, ``tissue banks'' shall not 
include eye banks.
    Section 102(b)(1)(A) of the bill amends section 371(b) of 
existing law to modify the descriptor for an OPO.
    Section 102(b)(1)(B) of the bill makes a technical 
amendment concerning paragraph alignment for subparagraph (E) 
of existing law.
    Section 102(b)(1)(C) of the bill modifies section 
371(b)(1)(G) of existing law specifying that hospital-based 
OPO's established before September 1993 may be directed by an 
advisory board. The bill requires that a ``reasonable balance'' 
of representatives sit on the OPO's board of directors and that 
transplant patients and/or family members of transplant donors 
sit on this board. The bill provides the following as examples 
of health care professionals who are qualified to be OPO board 
members, adding to the existing list: physicians or other 
health care professionals with knowledge and skill in the field 
of neurology, emergency medicine, or trauma surgery. In 
addition, physicians who are actively and directly involved in 
caring for the transplant patient would be qualified to become 
members of the OPO board of directors.
    Section 102(b)(2) of the bill eliminates paragraph (2) in 
existing law that directed the Secretary to publish rules to 
establish criteria for determining whether an entity meets the 
requirements of an OPO, as set forth in the legislation.
    Section 102(b)(3) of the bill redesignates (3) in existing 
law as paragraph (2).
    Section 102(b)(4)(A) of the bill revises agreements 
required between OPO's and hospitals. Consequently, OPO's must 
have agreements with all hospitals in their service areas, 
unless they have been granted waivers by the Secretary.
     Section 102(b)(4)(B) of the bill makes technical 
amendments, redesignating the order of paragraphs.
    Section 102(b)(4)(C) of the bill adds new sections to 
existing law requiring OPO's to conduct and participate in 
systematic efforts to increase the number of potential donors, 
including minority populations (for which there is a greater 
degree of organ shortage than in of the general population). 
Also, OPO's will be required to abide by the rules of the 
federally supported Network.
    Section 102(b)(4)(D) of the bill amends section 371(G) (as 
so redesignated) to require OPO's to adhere to an allocation 
system that utilizes:
    (a) a single list that encompasses an entire service area;
    (b) a list that encompasses at least an entire State;
    (c) a list that encompasses an approved alternative local 
unit; or
    (d) a list that encompasses another allocation system which 
has been approved by the Network and the Secretary.
    Section 102(b)(4)(E) of the bill modifies the requirement 
for transplant center and OPO coordination, calling for 
increased involvement in activities to promote organ donation.
    Section 102(b)(4)(F) of the bill directs OPO's to submit 
data to the Network concerning their effectiveness in organ 
procurement.
    Section 102(b)(5) of the bill defines the term 
``alternative local unit'' (as referred to in paragraph 
371(b)(2)(G) of the amended law), and specifies the terms under 
which the Secretary may assign this classification. A local 
unit is:
    (a) a unit composed of two or more OPO's; or
    (b) a subdivision of an OPO that operates as a result of 
special geographic, rural, or minority population concerns but 
is not composed of any subunit of a metropolitan statistical 
area.
    Section 102(c) of the bill indicates that current 
amendments to OPO requirements shall not affect provisions of 
section 1138(a) of the Social Security Act (42 U.S.C. 1320b-
8(a)).
    Section 102(d) of the bill establishes January 1, 1996, as 
the effective date for amendments to section 371(b) of the law 
as it applies to OPO's and the Network.
    Section 103(a)(1) of the bill amends section 372(a) of the 
PHSA to assert findings by Congress. Congress finds that:
    (a) it is in the public interest to maintain and improve 
the Federal network for organ sharing (the Network) and to 
assist OPOs with the distribution of organs for human 
transplantation;
    (b) there should be a private-public partnership with a 
continued role for the Federal Government in providing 
oversight and assistance for services provided by the Network; 
and
    (c) the Federal Government should actively oversee 
activities of the Network to ensure that its policies and 
procedures for procuring and distributing organs are fair, 
efficient, and in compliance with all applicable laws and 
standards. However, primary responsibility for establishing 
medical criteria and standards for organ procurement and 
transplantation reside with the Network.
    Section 103(a)(2) of the bill directs the Secretary to 
provide contracts for operation of the Network as stipulated in 
Section 372(b) of the PHSA (Organ Procurement and 
Transplantation Network).
    Section 103(a)(3) of the bill establishes the Network as a 
private entity that has experience in organ procurement and 
transplantation whose main purpose is to encourage organ 
donation, maintain a waiting list, and operate and monitor an 
equitable and effective system for allocating organs to 
transplant recipients.
     Section 103(a)(4) of the bill directs the Network to 
assess a patient registration fee (to be collected by the 
contractor), in an amount that is reasonable, customary, and 
determined by the Network, and approved by the Secretary of 
HHS. The fees are to be calculated so that they may cover the 
Network's reasonable cost of operation. The Secretary will have 
60 days to respond to a proposed patient registration fee 
schedule.
    Section 103(a)(5) of the bill requires that increases in 
the patient registration fees be limited to:
    (a) increases in the level or cost of contract tasks and 
other activities related to organ procurement and 
transplantation; or
    (b) decreases in expected revenue from patient registration 
fees available to the contractor.
    Section 103(a)(6) of the bill requires that fees collected 
by the Network be available as needed, without fiscal year 
limitation. Fees are subject to annual audit under the 
provisions of the Office of Management and Budget Circular No. 
A-133, entitled ``Audits of Institutions of Higher Learning and 
Other Nonprofit Institutions.'' A report concerning the audit 
and recommendations regarding expenditures will be submitted to 
the Network, the contractor, and the Secretary.
    Section 103(a)(7) of the bill directs the Secretary to 
collect a data management fee from transplant hospitals and 
OPO's. Data management fees are intended to cover:
    (a) the costs of operating and administering the Scientific 
Registry; and
    (b) the costs of contracts and cooperative agreements to 
support efforts to increase organ donation. The data management 
fees will be set annually by the Network in an amount 
determined by the Network in consultation with the Secretary. 
These fees will be calculated so that the per-transplant data 
management fee is divided into two: the patient-specific 
transplant center will pay 80 percent, and the procuring organ 
procurement organization will pay 20 percent of the transplant 
data management fee. These fees will be available to the 
Secretary and the contractor operating the Scientific Registry 
without fiscal year limitation. Expenditures of the data 
management fees by the contractor are subject to annual 
independent audit and reported along with recommendations to 
the Network, the contractor, and the Secretary.
    Section 103(a)(8) of the bill authorizes the Secretary and 
the Comptroller General to have access to all data collected by 
the contractor in carrying out its responsibilities under the 
contract.
    Section 103(b)(1) of the bill amends section 372(b)(1)(B) 
of the current law by stipulating additional requirements for 
the Network. The Network must include on its board of directors 
the following:
    (a) ``a reasonable portion'' of individuals who have 
received an organ transplant; individuals who are part of the 
family of organ transplant patients or transplant candidates; 
and individuals who are part of the family of those who have 
been organ donors or recipients; and
    (b) the Division of Transplantation of the Bureau of Health 
Resources Development (the Health Resources and Services 
Administration) shall be represented at all meetings except for 
those pertaining to the Network contractor's internal business.
    Also, the Network is required to have a patient affairs 
committee and a minority affairs committee. Section 
372(b)(1)(B) is also amended to require representation by a 
member of the Division of Organ Transplantation of the Bureau 
of Health Resources Development (the Health Resources and 
Services Administration) at all meetings of all committees of 
the Network. The board of directors may also include members 
from OPO's and physicians or other health care professionals 
with knowledge about organ transplantation.
    Section 103(b)(2) of the bill states requirements for 
operation of the Network. It directs the Network to establish 
within all OPO's (with respect to each type of transplant) a 
national list of individuals who have been medically referred 
to receive a transplant, including the names of patients on the 
lists in effect under section 371(b)(2)(G). The Network is 
further directed to establish membership criteria and medical 
criteria for organ allocation and to provide members of the 
public an opportunity for public comment. The Network is 
charged with assisting and monitoring OPO's in the equitable 
distribution of organs among transplant patients. A new 
requirement directs the Network to make recommendations to 
OPO's and the Secretary for increasing organ donations based on 
effectiveness data submitted by OPO's, under new section 
371(b)(2)(L). Other new responsibilities for the Network are 
to: (1) submit biennial reports to the Secretary containing 
information on patient outcomes at each transplant center 
affiliated with the Network, including survival information, 
waiting list information, and information pertaining to the 
qualifications and experience of transplant surgeons and 
physicians affiliated with the Network program; (2) submit to 
the Secretary justification for any proposed increase in 
patient registration fees; (3) make available to the Secretary 
information about the Network; (4) submit to the Secretary an 
annual report on the scientific and clinical status of organ 
donation and transplantation; and (5) comply with other 
requirements established by the Secretary.
    Section 103(c) of the bill amends section 372(c) of the 
PHSA authorizing the Secretary to work through, work with, and 
direct the Network contractor to define priorities and respond 
to new emerging issues and problems.
    Section 103(d) instructs the Network contractor, in 
consultation with the Network, within 1 year of completion of 
the study, to implement the IOM study recommendation with 
respect to the expansion of public access to Network committees 
and board of directors.
    Section 103(e) instructs the Secretary to publish a final 
rule establishing regulations for criteria under part H of 
title III of the PHSA within one year of enactment, with 
consideration of the policies and bylaws of the Network. 
Failure to issue regulations by the statutory date will require 
the Secretary to issue, within 30 days of the deadline, a 
report to the Congress describing the reasons for failure to 
comply with the law and the steps which are being implemented 
to bring the Department into compliance.
    Section 104 amends section 374 of the PHSA to establish 
terms and conditions for contracts entered into under section 
371 of the PHSA. A limit of $250,000 (or 10 percent of the 
amount) of data management fees collected under section 372 
(whichever is greater) is to be used to fund contracts 
described in section 371. No contract in excess of $25,000 is 
to be made using funds withheld under subsection (c)(1) unless 
an application has been submitted to the Secretary, recommended 
by the Network, and approved by the Secretary.
    Section 105 of the bill amends section 375 of the PHSA 
(Administration) by assigning the Secretary responsibility to 
oversee the Network in carrying out its administrative 
function. The Secretary will prepare, through contract, a 
triennial report on OPO-specific data that includes:
    (a) data about the effectiveness of OPO's in procuring 
organs, particularly among minority populations;
    (b) data concerning the variation of procurement across 
hospitals within the OPO region;
    (c) a plan to increase organ procurement, particularly 
among minority populations, for which there is a greater degree 
of organ shortage relative to the general population; and
    (d) a plan to increase procurement at hospitals with low 
rates of procurement.
    Section 106 of the bill amends section 377 of the PHSA and 
calls for the Institute of Medicine to conduct a study and an 
evaluation of:
    (a) the role and impact of the Federal Government in the 
oversight and support of solid-organ transplantation, the 
Network, and the solid-organ Scientific Registry; and
    (b) the access of all interested constituencies and 
organizations to membership on the Network's board of directors 
and all committees.
    If the IOM declines to conduct this study and evaluation, 
the Secretary shall appoint another public or nonprofit group 
to do it. Within 2 years of enactment of the bill, the 
completed study shall be submitted to the Senate Committee on 
Labor and Human Resources.
    Section 107(a) of the bill further amends section 374 of 
the PHSA and replaces in all parts of section 374, the word 
``contracts'' for ``grants.'' The monetary limit of $100,000 
for which OPO grants may be awarded is removed.
    Section 107(b) of the bill repeals sections 376 (Report) 
and 378 (Authorization of Appropriations) of the PHSA.
    Section 108 of the bill amends part H of title III of the 
PHSA by adding ``Sec. 378. Authorization of Appropriations.'' 
There are authorized to be appropriated to carry out sections 
371, 372, and 373, $1,950,000 for fiscal year 1997, and 
$1,100,000 for fiscal year 1998, and to carry out section 371, 
$250,000 for each of the fiscal years 1999 through 2001.
    Section 109 of the bill specifies that the amendments made 
by this title are effective on the date of enactment.

                  Title II--Bone Marrow Donor Program

    Section 201 of the bill cites the short title as the ``Bone 
Marrow Transplantation Program Reauthorization Act of 1995.''
    Section 202(a) of the bill amends section 379(b) of the 
PHSA (National Marrow Donor Registry) to reauthorize the 
National Bone Marrow Donor Registry. Section 202(a)(1) amends 
379(a) to establish that the primary purpose of the Donor 
Registry is to increase the number of unrelated donor marrow 
transplants, as specified by the bill. Section 379(a) of the 
Public Health Service Act (PHSA) is amended to set term limits 
for those serving as members of the board of directors for the 
National Marrow Donor Registry. Members may serve for 2-year 
terms, for as many as three consecutive terms. To ensure 
continuity of the composition of the board, the maximum number 
of newly appointed members in any given year is limited such 
that not more than one-third are selected in any given year. 
Board-appointed members of committees are limited to 2 years, 
with one-third of the members of each committee subject each 
year to replacement and with no member serving more than three 
consecutive 2-year terms. The board and committees are required 
to be composed of a reasonable balance of representatives of 
donor centers, transplant centers, blood banks, marrow 
transplant recipients, and individuals who are family members 
of an individual who has required, received, or is registered 
with the Donor Registry to become a recipient of a bone marrow 
transplant. In addition, the bill requires board representation 
from the Naval Medical Research and Development Command and the 
Division of Organ Transplantation of the Bureau of Health 
Resources Development (of the Health Resources and Services 
Administration).
    Section 202(b) of the bill amends the functions of the 
Federal program for the Donor Registry, under section 379(b) of 
the existing law, requiring that patients and physicians 
thoroughly integrate resources available to the Donor Registry 
Program (i.e., patient advocacy and case management office, and 
other marrow donor registries). The bill requires the Donor 
Registry to establish a program for recruiting new bone marrow 
donors that will focus on: (1) increasing minority donors, 
since there is a greater degree of marrow donor shortage among 
this group than among the general population, and (2) compiling 
and distributing information and materials to increase 
awareness among the general population. This new section amends 
PHSA to require the Donor Registry to update annually donor 
listings and to require the Secretary of the Department of 
Health and Human Services (HHS) to develop, evaluate, and 
implement a plan to streamline and enhance the efficiency of 
the relationship between the Donor Registry and donor centers 
upon completion of the ``Bone Marrow Program Inspection.''
    Section 202(c) of the bill amends section 379 to create an 
information and education program calling for the Secretary to 
award contracts to public or nonprofit private groups to engage 
in education and training activities in the community for the 
purpose of increasing unrelated allogeneic marrow transplants. 
Priorities for award distribution will be given to those 
projects aimed at increasing marrow donations among minority 
populations.
    Section 202(d) of the bill further amends Section 379 of 
the current law to direct the Donor Registry to establish a new 
Office of Patient Advocacy and Case Management. Functions 
include: (1) leadership by a director-advocate serving in the 
interest of patients, physicians, and potential marrow donors; 
(2) creation and maintenance of a system for patient advocacy 
that assists patients, their families, and physicians in search 
of an unrelated marrow donor; (3) provision of individual case 
management services to patients, their families, and 
physicians; (4) collection and analysis of data about the 
search process (from search to transplantation), including 
costs incurred by patients prior to transplantation; (5) 
evaluations of patient satisfaction with the search process; 
and (6) provision of individual case-management services to 
marrow donors. The Secretary is directed to evaluate the office 
of patient advocacy and case management and make 
recommendations concerning the success or failure of this new 
office and its impact on the assistance to individuals in 
proceeding to marrow transplantation. Subsequently, the 
Secretary shall release a report on the foregoing evaluation by 
April 1, 1996.
    Section 202(e) of the bill amends section 379A to read: 
``Sec. 379A. Studies, Evaluations, and Reports.''
    The new section 379A(a) authorizes the Secretary of HHS to 
enter into a contract with a public or nonprofit private 
organization to do a study and evaluation of: (1) the role of 
the federally supported bone marrow transplant program in 
facilitating the maximum number of unrelated marrow donor 
transplants; and (2) other uses for the potential donor pool or 
accompanying information maintained by the Donor Registry. In 
addition, at the request of the Secretary, the Institute of 
Medicine (IOM) of the Academy of Sciences shall conduct the 
aforementioned study. If the IOM refuses, the Secretary shall 
arrange for another group to conduct the study as specified by 
law. Upon completion of the study, either the IOM or (other 
entity as the case may be) is required to submit a report to 
the Senate Committee on Labor and Human Resources.
    Section 379A(b) directs the Secretary to conduct a study 
on: (1) the evaluation of the feasibility of consolidating all 
federally funded bone marrow transplantation scientific 
registries; and (2) the evaluation of all federally funded bone 
marrow transplantation research conducted by the National 
Institutes of Health. The term ``marrow reconstitution'' is 
defined as encompassing all sources of blood cells, including 
marrow (autologous, related or unrelated allogeneic, 
syngeneic), autologous marrow, allogeneic marrow (biologically 
related or unrelated), umbilical cord blood cells, peripheral 
blood progenitor cells, or other approaches that may be 
utilized.
    Section 202(f) of the bill amends part I of title III of 
the PHSA by adding the following new section: ``Sec. 379B. Bone 
Marrow Scientific Registry.''
    The new section 379B(a) directs the Secretary of HHS to 
establish and maintain a Scientific Registry of all recipients 
of biologically unrelated allogeneic marrow donors.
    Section 379B(b) defines the type of information the newly 
created Bone Marrow Scientific Registry is obligated to 
maintain. The Scientific Registry must collect information 
about biologically unrelated allogeneic marrow transplants, 
transplant procedures, pretransplant and transplant costs, and 
other information the Secretary deems necessary.
    Section 379B(c) requires the Donor Registry to submit to 
the Secretary on an annual basis a report using data collected 
and maintained by the marrow transplantation Scientific 
Registry containing information about patient outcomes with 
respect to each transplant center, and pretransplant 
comparative costs involved.
    Section 379B(g) of the bill amends part I of title III of 
the PHSA by adding the following new section: ``Sec. 379C. 
Authorization of Appropriations.'' This section authorizes to 
be appropriated, for activities specified under section 379, 
totals of $13,500,000 for fiscal year 1997, $12,150,000 for 
fiscal year 1998, and such sums as may be necessary for fiscal 
year 1999.

                     VIII. 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

  ORGAN AND BONE MARROW TRANSPLANT PROGRAM REAUTHORIZATION ACT OF 1995

          * * * * * * *

                    ORGAN PROCUREMENT ORGANIZATIONS

    Sec. 371. [(a)(1) The Secretary may make grants for the 
planning of qualified organ procurement organizations described 
in subsection (b).
    [(2) The Secretary may make grants for the establishment, 
initial operation, consolidation, and expansion of qualified 
organ procurement organizations described in subsection (b).
    [(3) The Secretary may make grants to, and enter into 
contracts with, qualified organ procurement organizations 
described in subsection (b) and other nonprofit private 
entities for the purpose of carrying out special projects 
designed to increase the number of organ donors.]
    (a)(1) The Secretary may enter into cooperative agreements 
and contracts with qualified organ procurement organizations 
described in subsection (b) and other public or nonprofit 
private entities for the purpose of increasing organ donation 
through approaches such as--
          (A) the planning and conducting of programs to 
        provide information and education to the public on the 
        need for organ donations:
          (B) the training of individuals in requesting such 
        donations:
          (C) the provision of technical assistance to organ 
        procurement organizations and other entities that can 
        contribute to organ donation;
          (D) the performance of research and the performance 
        of demonstration programs by organ procurement 
        organizations and other entities that may increase 
        organ donation;
          (E) the voluntary consolidation of organ procurement 
        organizations and tissue banks or
          (F) increasing organ donation and access to 
        transplantation with respect to populations for which 
        there is a greater degree of organ shortages relative 
        to the general population.
    (2)(A) In entering into cooperative agreements and 
contracts under subparagraphs (A) and (B) of paragraph (1), the 
Secretary shall give priority to increasing donations and 
improving consent rates for the purpose described in such 
paragraph.
    (B) In entering into cooperative agreements and contracts 
under paragraph (1)(C), the Secretary shall give priority to 
carrying out the purpose described in such paragraph with 
respect to increasing donations from both organ procurement 
organizations and hospitals.
    (b) Qualified Organizations.
          (1) A qualified organ procurement organization [for 
        which grants may be made under subsection (a)] 
        described in this section is an organization which, as 
        determined by the Secretary, will carry out the 
        functions described in [paragraph (2)] Paragraph (3) 
        and--
          * * * * * * *
                  [(E)]
                  (E) * * *
          * * * * * * *
                  (G) has a board of [directors or an advisory 
                board] directors (or an advisory board, in the 
                case of a hospital-based organ procurement 
                organization established prior to September 1, 
                1993) which--
                          (i) is [composed of] composed of a 
                        reasonable balance of--
          * * * * * * *
                                  (II) members who represent 
                                the public residing in such 
                                area including individuals who 
                                have received a transplant of 
                                an organ (or transplant 
                                candidates), and individuals 
                                who are part of the family of 
                                an individual who has donated 
                                or received an organ or who is 
                                a transplant candidate,
          * * * * * * *
                                  [(IV)] a physician with 
                                knowledge or skill in the field 
                                of neurology, and]
                                  (IV) physicians or other 
                                health care professionals with 
                                knowledge and skill in the 
                                field of neurology, emergency 
                                medicine, or trauma surgery
                                  (V) from each transplant 
                                center in its service area 
                                which has arrangements 
                                described in paragraph (2)(G) 
                                with the organization, [a 
                                member who is a surgeon who has 
                                practicing privileges in such 
                                center and who performs organ 
                                transplant surgery,] a member 
                                who is a surgeon or physician 
                                who has privileges to practice 
                                in such centers and who is 
                                actively and directly involved 
                                in caring for transplant 
                                patients,
          * * * * * * *
          [(2)(A) Not later than 90 days after the date of 
        enactment of this paragraph, the Secretary shall 
        publish in the Federal Register a notice of proposed 
        rulemaking to establish criteria for determining 
        whether an entity meets the requirement established in 
        paragraph (1)(E).
          (B) Not later than 1 year after the date of enactment 
        of this paragraph, the Secretary shall publish in the 
        Federal Register a final rule to establish the criteria 
        described in subparagraph (A).]
          [(3)] (2) An organ procurement organization shall--
                  (A) have effective agreements, to identify 
                potential organ donors, with [a substantial 
                majority] all of the hospitals and other health 
                care entities in its service area which have 
                facilities for organ [donations] 
                donation,unless they have been previously 
                granted by the Secretary a waiver from 
                paragraph (1)(A) or have waivers pending under 
                section 1138 of the Social Security Act, except 
                that the Secretary may waive the requirements 
                of this subparagraph upon the request of the 
                organ procurement organization if the Secretary 
                determines that such an agreement would not be 
                helpful in promoting organ donation,
                  (B) conduct and participate in systematic 
                efforts including public education, to increase 
                the number of potential donors, including 
                populations for which there is a greater degree 
                of organ shortage than that of the general 
                population,
                  (C) be a member of and abide by the rules and 
                requirements of the Organ Procurement and 
                Transplantation Network (referred to in this 
                part as the `Network') established under 
                section 372,
                  [(B)] (D) conduct and participate in 
                systematic efforts, including professional 
                education, to acquire all useable organs from 
                potential donors,
                  [(C)] (E) arrange for the acquisition and 
                preservation of donated organs and provide 
                quality standards for the acquisition of organs 
                which are consistent with the standards adopted 
                by the Organ Procurement and Transplantation 
                Network under section 372(b)(2)(E), including 
                arranging for testing with respect to 
                preventing the acquisition of organs that are 
                infected with the etiologic agent for acquired 
                immune deficiency syndrome,
                  [(D)] (F) arrange for the appropriate tissue 
                typing of donated organs,
                  [(E)] (G) have a system to allocate donated 
                organs equitably among transplant patients 
                according to established medical criteria, 
                which system shall, at a minimum, allocate each 
                type of organ on the basis of--
                          (i) a single list encompassing the 
                        entire service area;
                          (ii) a list that encompasses at least 
                        an entire State;
                          (iii) a list that encompasses an 
                        approved alternative local unit (as 
                        defined in paragraph (3)) that is 
                        approved by the Network and the 
                        Secretary, or
                          (iv) a list that encompasses another 
                        allocation system which has been 
                        approved by the Network and the 
                        Secretary,
                of individuals who have been medically referred 
                to a transplant center the service area of the 
                organization in order to receive a transplant 
                of the type of organ with respect to which the 
                list is maintained and had been placed on an 
                organ specific waiting list;
                  [(F)] (H) provide or arrange for the 
                transportation of donated organs to transplant 
                centers,
                  [(G)] (I) have arrangements to coordinate its 
                activities with transplant centers in its 
                service area and work with local transplant 
                centers to ensure that such centers are 
                actively involved with organ donation efforts,
                  [(H)] (J) participate in the Organ 
                Procurement Transplantation Network established 
                under section 372,
                  [(I)] (K) have arrangements to cooperate with 
                tissue banks for the retrieval, processing, 
                preservation, storage, and distribution of 
                tissues as may be appropriate to assure that 
                all useable tissues are obtained from potential 
                donors,
                  [(J)] (L) evaluate annually and submit data 
                to the Network contractor on the effectiveness 
                of the organization, the effectiveness of the 
                organization in acquiring potentially available 
                organs, and
                  [(K)] (M) assist hospitals in establishing 
                and implementing protocols for making routine 
                inquiries about organ donation by potential 
                doors.
          (3)(A) As used in paragraph (2)(G), the term 
        `alternative local unit' means--
                  (i) a unit composed of two or more organ 
                procurement organizations; or
                  (ii) a subdivision of an organ procurement 
                organization that operates as a distinct 
                procurement and distribution unit as a result 
                of special geographic, rural, or population 
                concerns but that is not composed of any 
                subunit of a metropolitan statistical area.
          (B) The Network shall make recommendations to the 
        Secretary concerning the approval or denial of 
        alternative local units. The Network shall assess 
        whether the alternative local units will better promote 
        organ donation and the equitable allocation of organs.
          (C) The Secretary shall approve or deny any 
        alternative local unit designation recommended by the 
        Network. The Secretary shall have 60 days, beginning on 
        the date on which the application is submitted to the 
        Secretary, to approve or deny the recommendations of 
        the Network under subparagraph (B) with respect to the 
        application of the alternative local unit.

             organ procurement and transplantation network

    Sec. 372. [(a) The Secretary shall by contract provide for 
the establishment and operation of an Organ Procurement and 
Transplantation Network which meets the requirements of 
subsection (b). The amount provided under such contract in any 
fiscal year may not exceed $2,000,000. Funds for such contracts 
shall be made available from funds available to the Public 
Health Service from appropriations for fiscal years beginning 
after fiscal year 1984.]
    (a) (1) Congress finds that--
          (A) it is in the public interest to maintain and 
        improve a durable system for promoting and supporting a 
        central network to assist organ procurement 
        organizations in the nationwide distribution of organs 
        among transplant patients;
          (B) it is desirable to continue the partnership 
        between public and private enterprise, by continuing to 
        provide Federal Government oversight and assistance for 
        services performed by the Network; and
          (C) the Federal Government should actively oversee 
        Network activities to ensure that the policies and 
        procedures of the Network for serving patient and donor 
        families and procuring and distributing organs are 
        fair, efficient and in compliance with all applicable 
        legal rules and standards; however, the initiative and 
        primary responsibility for establishing medical 
        criteria and standards for organ procurement and 
        transplantation still resides with the Network.
    (2) The Secretary shall provide by contract for the 
operation of the Network which shall meet the requirements of 
subsection (b).
    (3) The Network shall be recognized as a private entity 
that has an expertise in organ procurement and transplantation 
with the primary purposes of encouraging organ donation, 
maintaining a `wait list', and operating and monitoring an 
equitable and effective system for allocating organs to 
transplant recipients, and shall report to the Secretary 
instances of continuing noncompliance with policies (or when 
promulgated, rules) and requirements of the Network.
    (4) The Network may assess a fee (to be known as the 
`patient registration fee'), to be collected by the contractor 
for listing each potential transplant recipient on its national 
organ matching system, in an amount which is reasonable and 
customary and determined by the Network and approved as such by 
the Secretary. The patient registration fee shall be calculated 
so as to be sufficient to cover the Network's reasonable costs 
of operation in accordance with this section. The Secretary 
shall have 60 days, beginning on the date on which the written 
application justifying the proposed fee as reasonable is 
submitted to the Secretary, to provide the Network with a 
written determination and rationale for such determination that 
the proposed increase is not reasonable and customary and that 
the Secretary disapproves the recommendation of the Network 
under this paragraph with respect to the change in fee for 
listing each potential transplant recipient.
    (5) Any increase in the patient registration fee shall be 
limited to an increase that is reasonably required as a result 
of--
          (A) increases in the level or cost of contract tasks 
        and other activities related to organ procurement and 
        transplantation; or
          (B) decreases in expected revenue from patient 
        registration fees available to the contractor.
The patient registration fees shall not be increased more than 
once during each year.
    (6) All fees collected by the Network contractor under 
paragraph (4) shall be available to the Network without fiscal 
year limitation. The contract with the Network contractor shall 
provide that expenditures of such funds (including patient 
registration fees collected by the contractor and or contract 
funds) are subject to an annual audit under the provisions of 
the Office of Management and Budget Circular No. A-133 entitled 
`Audits of Institutions of Higher Learning and Other Nonprofit 
Institutions' to be performed by the Secretary or an authorized 
auditor at the discretion of the Secretary. A report concerning 
the audit and recommendations regarding expenditures shall be 
submitted to the Network, the contractor, and the Secretary.
    (7) The Secretary may institute and collect a data 
management fee from transplant hospitals and organ procurement 
organizations. Such fees shall be directed to and shall be 
sufficient to cover--
          (A) the costs of the operation and administration of 
        the Scientific Registry in accordance with the contract 
        under section 373; and
          (B) the costs of contracts and cooperative agreements 
        to support efforts to increase organ donation under 
        section 371.
Such data management fees shall be set annually by the Network 
in an amount determined by the Network, in consultation with 
the Secretary, and approved by the Secretary. Such data 
management fee shall be calculated to be sufficient to cover 
the reasonable costs of operation in accordance with section 
373. Such data management fee shall be calculated based on the 
number of transplants performed or facilitated by each 
transplant hospital or center, or organ procurement 
organization. The per transplant data management fee shall be 
divided so that the patient specific transplant center will pay 
80 percent and the procuring organ procurement organization 
will pay 20 percent of the per transplant data management fee. 
Such fees shall be available to the Secretary and the 
contractor operating the Scientific Registry without fiscal 
year limitation. The expenditure (including fees or contract 
funds) of such fees by the contractor shall be subject to an 
annual independent audit (performed by the Secretary or an 
authorized auditor at the discretion of the Secretary) and 
reported along with recommendations regarding such 
expenditures, to the Network, the contractor and the Secretary.
    (8) The Secretary and the Comptroller General shall have 
access to all data collected by the contractor or contractors 
in carrying out its responsibilities under the contract this 
section and section 373.
    (b)(1)(B)(i) that includes representatives of organ 
procurement organizations [(including organizations that have 
received grants under section 371)], transplant centers, 
voluntary health associations, and the general public[; and] 
(including both individuals who have received a transplant of 
an organ (or transplant candidates), individuals who are part 
of the family of individuals who have donated or received an 
organ, the number of whom shall make up a reasonable portion of 
the total number of board members), and the Division of Organ 
Transplantation of the Bureau of Health Resources Development 
(the Health Resources and Services Administration) shall be 
represented at all meetings except for those pertaining to the 
Network contractor's internal business;
    (ii) that shall establish an executive committee and other 
committees including a patient affairs committee and a minority 
affairs committee, whose chairpersons shall be selected to 
ensure continuity of leadership for the board[.];
    (iii) that shall include representation by a member of the 
Division of Organ Transplantation of the Bureau of Health 
Resources Development (the Health Resources and Services 
Administration) as a representative at all meetings (except for 
those portions of committee meetings pertaining to the Network 
contractor's internal business) of all committees (including 
the executive committee, finance committee, nominating 
committee, and membership and professional standards committee) 
under clause (ii);
    (iv) that may include a member from an organ procurement 
organization on all committees under clause (ii); and
    (v) that may include physicians or other health care 
professionals with knowledge and skill in the field of 
neurology, emergency medicine, and trauma surgery on all 
committees under clause (ii).
    (2) The Organ Procurement and Transplantation Network 
shall--
          (A) establish in one location [or through regional 
        centers] and at each Organ Procurement Organization--
                  [(i) a national list of individuals who need 
                organs, and]
                  (i) with respect to each type of transplant, 
                a national list of individuals who have been 
                medically referred to receive a transplant of 
                the type of organs with respect to which the 
                list is maintained (which list shall include 
                the names of all individuals included on lists 
                in effect under section 371(b)(2)(G)), and
          * * * * * * *
          (B) establish membership criteria, including 
        requirements under section 371(b), and medical criteria 
        for allocating organs and provide to members of the 
        public an opportunity to comment with respect to such 
        criteria,
          * * * * * * *
          (E) assist and monitor organ procurement 
        organizations in the equitable distribution of organs 
        among transplant patients,
          [(E)] (F) adopt and use standards of quality for the 
        acquisition and transportation of donated organs, 
        including standards for preventing the acquisition of 
        organs that are infected with the etiologic agent for 
        acquired immune deficiency syndrome,
          [(F)] (G) prepare and distribute, on a regionalized 
        basis (and, to the extent practicable, among regions or 
        on a national basis), samples of blood sera from 
        individuals who are included on the list and whose 
        immune system makes it difficult for them to receive 
        organs, in order to facilitate matching the 
        compatibility of such individuals with organ donors,
          [(G)] (H) coordinate, as appropriate, the 
        transportation of organs from organ procurement 
        organizations to transplant centers,
          [(H)] (I) provide information to physicians and other 
        health professionals regarding organ donation,
          [(I)] (J) collect, analyze, and publish data 
        concerning organ donation and transplants,
          [(J)] (K) carry out studies and demonstration 
        projects for the purpose of improving procedures for 
        organ procurement and allocation, [and]
          [(K)] (L) work actively to increase the supply of 
        donated organs[.], including making recommendations to 
        organ procurements organizations and the Secretary 
        based on data submitted to the network under section 
        371(b)(2)(L),
          [(L)] (M) submit to the Secretary an [annual] 
        biennial report containing information on [the 
        comparative costs and] patient outcomes at each 
        transplant center affiliated with the organ procurement 
        and transplantation network[.], including survival 
        information, waiting list information, and information 
        pertaining to the qualifications and experience of 
        transplant surgeons and physicians affiliated with the 
        specific Network programs,
          (N) submit to the Secretary for approval a written 
        notice containing a justification, as reasonable and 
        customary, of any proposed increase in the patient 
        registration fees as maintained under subparagraph 
        (A)(i), such change to be considered as so approved in 
        the Secretary does not provide written notification 
        otherwise prior to the expiration of the 60-day period 
        beginning on the date on which the notice of proposed 
        change is submitted to the Secretary,
          (O) make available to the Secretary such information, 
        books, and records regarding the Network as the 
        Secretary may require,
          (P) submit to the Secretary, in a manner prescribed 
        by the Secretary, an annual report concerning the 
        scientific and clinical status of organ donation and 
        transplantion, and
          (Q) meet such other criteria regarding compliance 
        with this part as the Secretary may establish.
    (c) The Secretary shall establish procedures for--
          (1) receiving for interested persons critical 
        comments relating to the manner in which the Organ 
        Procurement and Transplantation Network is carrying out 
        the duties of the Network under subsection (b); [and]
          (2) the consideration by the Secretary of such 
        critical comments[.];
          (3) working through and with, the Network contractor 
        to define priorities; and
          (4) working through, working with, and directing the 
        Network contractor to respond to new emerging issues 
        and problems.
    (d) Expansion of Access to Committees and Board of 
Directors.--Not later than 1 year after the completion of the 
Institute of Medicine report required under section 377, the 
Network contractor, in consultation with the Network and the 
Secretary, shall present to the Secretary and the appropriate 
committees of Congress, a plan to implement the study 
recommendations relating to the access of all interested 
constituencies and organizations to membership on the Network 
Board of Directors and all of its committees. Ensuring the 
reasonable mix of all populations shall be a priority of the 
plan for implementation.
          * * * * * * *

          general provisions respecting [grants and] contracts

    Sec. 374. (a) No [grant may be made under this part or 
contract] contract may be entered into under section 372 or 373 
unless an application therefore has been submitted to, and 
approved by, the Secretary. Such an application shall be in 
such form and shall be submitted in such manner as the 
Secretary shall by regulation prescribe.
    (b)(1) A [grant] contract for planning section 371(a)(1) 
may be made for one year with respect to any organ procurement 
organization [and may not exceed $100,000].
    [(2) Grants under section 371(a)(2) may be made for [two 
years] three years. No such grant may exceed $500,000 for any 
year and no organ procurement organization may receive more 
than $800,000 for initial operation or expansion.]
    [(3)] (2) [Grants or contracts] Contracts under section 
[371(a)(3)] 371(a)(2) may be mode for not more than 3 years.
    (c)(1) The Secretary shall annually withhold not to exceed 
$250,000 or 10 percent of the amount of the data management 
fees collected under section 372 (whichever is greater) to be 
used to fund contracts as described in section 371.
    [(1)] (2) The Secretary shall determine the amount of a 
[grant or] contract made under section 371 or 373. Payments 
under such [grants and] contracts may be made in advance on the 
basis of estimates or by the way of reimbursement, with 
necessary adjustments on account of underpayments or 
overpayments, and in such installments and on such terms and 
conditions as the Secretary finds necessary to carry out the 
purposes of such grants and contracts.
    [(2)] (3) (A) Each recipient of a [grant or] contract under 
section 371 or 373 shall keep such records as the Secretary 
shall prescribe, including records which fully disclose the 
amount and disposition by such recipient of the proceeds of 
such [grant or] contract, the total cost of the undertaking in 
connection with which such [grant or] contract was made, and 
the amount of that portion of the cost of the undertaking 
supplied by other sources, and such other records as will 
facilitate an effective audit.
    (B) The Secretary and the Comptroller General of the United 
States, or any of their duly authorized representatives, shall 
have access for the purpose of audit and examination to any 
books, documents, papers, and records of the recipient of a 
[grant or] contract under section 371 or 373 that are pertinent 
to such [grant or] contract.
    [(d)] (e) * * *
    (d) No contract in excess of $25,000 may be made under this 
part using funds withheld under subsection (c)(1) unless an 
application for such contract has been submitted to the 
Secretary, recommended by the Network and approved by the 
Secretary. Such an application shall be in such form and be 
submitted in such a manner as the Secretary shall prescribe.
          * * * * * * *
    (2) The term ``organ'' means the human kidney, liver, 
heart, lung, pancreas, and any other human organ (other than 
corneas and eyes) specified by the Secretary by regulation [and 
for purposes of section 373, such term includes bone marrow].
          * * * * * * *
    Sec. 375. The Secretary shall designate and maintain an 
identifiable administrative unit in the Public Health Service 
to oversee the Network, the Scientific Registry and to--
          * * * * * * *
          (3) provide technical assistance to organ procurement 
        organizations, the Organ Procurement and 
        Transplantation Network established under section 372, 
        and other entities [in the health care system] involved 
        in organ donations, procurement, and transplants, [and]
          (4)(ii) to patients and their families about the 
        resources available nationally and in each State, and 
        the comparative costs and patient outcomes at each 
        transplant center affiliated with the organ procurement 
        and transplantation network, in order to assist the 
        patients and families with the costs associated with 
        transplantation[.]; and
          (5) through contract, prepare a triennial organ 
        procurement organization specific data report (the 
        initial report to be completed not later than 18 months 
        after the date of enactment of this paragraph) that 
        includes--
                  (A) data concerning the effectiveness of each 
                organ procurement organization in acquiring 
                potentially available organs, particularly 
                among minority populations;
                  (B) data concerning the variation of 
                procurement across hospitals within the organ 
                procurement organization region;
                  (C) a plan to increase procurement, 
                particularly among populations for which there 
                is a greater degree of organ shortages relative 
                to the general population; and
                  (D) a plan to increase procurement at 
                hospitals with low rates of procurement.
          * * * * * * *
    [Sec. 376. Not later than February 10 of 1991 and of each 
second year thereafter, the Secretary shall publish, and submit 
to the Committee on Energy and Commerce of the House of 
Representatives and the Committee on Labor and Human Resources 
of the Senate, a report on the scientific and clinical status 
of organ transplantation. The Secretary shall consult with the 
Director of the National Institutes of Health and the 
Commissioner of the Food and Drug Administration in the 
preparation of the report.]

[SEC. 377. STUDY BY GENERAL ACCOUNTING OFFICE.

    [(a) In General.--The Comptroller General of the United 
States shall conduct a study for the purpose of determining--
          [(1) the extent to which the procurement and 
        allocation of organs have been equitable, efficient, 
        and effective;
          [(2) the problems encountered in the procurement and 
        allocation; and
          [(3) the effect of State required-request laws.
    [(b) Report.--Not later than January 7, 1992, the 
Comptroller General of the United States shall complete the 
study required in subsection (a) and submit to the Committee on 
Energy and Commerce of the House of Representatives, and to the 
Committee on Labor and Human Resources of the Senate, a report 
describing the findings made as a result of the study.]

SEC. 377. STUDY AND REPORT.

    (a) Evaluation by the Institute of Medicine.--
          (1) In general.--The Secretary shall enter into a 
        contract with a public or nonprofit private entity to 
        conduct a study and evaluation of--
                  (A) the role of and the impact of the Federal 
                Government in the oversight and support of 
                solid-organ transplantation, the Network (which 
                on the date of enactment of this section 
                carries out its functions by government 
                contract) and the solid organ transplantation 
                scientific registry; and
                  (B) the access of all interested 
                constituencies and organizations to membership 
                on the Network board of directors and all 
                Network committees.
          (2) Institute of medicine.--The Secretary shall 
        request the Institute of Medicine of the National 
        Academy of Sciences to enter into the contract under 
        paragraph (1) to conduct the study and evaluation 
        described in such paragraph. If the Institute declines 
        to conduct the study and evaluation under such 
        paragraph, the Secretary shall carry out such 
        activities through another public or nonprofit private 
        entity.
    (b) Report.--Not later than 2 years after the date of 
enactment of this section, the Institute of Medicine (or other 
entity as the case may be) shall complete the study required 
under subsection (a)(1) and prepare and submit to the Committee 
on Labor and Human Resources of the Senate, a report describing 
the findings made as a result of the study.
    [Sec. 378. For the purpose of carrying out this part, there 
are authorized to be appropriated $8,000,000 for fiscal year 
1991, and such sums as may be necessary for each of the fiscal 
years 1992 and 1993.]

SEC. 378. AUTHORIZATION OF APPROPRIATIONS

    There are authorized to be appropriated to carry out 
sections 371, 372, 375 and 377, $1,950,000 for fiscal year 
1997, and $1,100,000 for fiscal year 1998, and to carry out 
section 371, $250,000 for each of the fiscal years 1999 through 
2001.
          * * * * * * *

SEC. 379. NATIONAL REGISTRY

    (a) Establishment.--The Secretary shall by contract 
establish and maintain a National Bone Marrow Donor Registry 
(referred to in this part as the [``Registry''] `Donor 
Registry') the primary purpose of which shall be increasing 
unrelated donor marrow transplants, that meets the requirements 
of this section. The Registry shall be under the general 
supervision of the Secretary, and under the direction of a 
board of directors that shall include representatives of marrow 
donor centers, marrow transplant centers, persons with 
expertise in the social science, and the general public. With 
respect to the board of directors--
          (1) each member of the board shall serve for a term 
        of 2 years, and each such member may serve as many as 
        three consecutive 2-year terms;
          (2) a member of the board may continue to serve after 
        the expiration of the term of such member until a 
        successor is appointed;
          (3) to ensure the continuity of the board, not more 
        than one-third of the board shall be composed of 
        members newly appointed each year;
          (4) all appointed and elected positions within 
        committees established by the board shall be for 2-year 
        periods;
          (5) the terms of approximately one-third of the 
        members of each such committee will be subject each 
        year to reappointment or replacement;
          (6) no individual shall serve more than three 
        consecutive 2-year terms on any such committee; and
          (7) the board and committees shall be composed of a 
        reasonable balance of representatives of donor centers, 
        transplant centers, blood banks, marrow transplant 
        recipients, individuals who are family members of an 
        individual who has required, received, or is registered 
        with the Donor Registry to become a recipient of a 
        transplant from a biologically unrelated marrow donor, 
        with nonvoting representatives from the Naval Medical 
        Research and Development Command and the Division of 
        Organ Transplantation of the Bureau of Health Resources 
        Development (of the Health Resources and Services 
        Administration).
          * * * * * * *
    (b)(2) [establish a system for patient advocacy, separate 
from mechanisms for donor advocacy, that directly assists] 
integrate the activities of the patient advocacy and case 
management office established under subsection (k) with the 
remaining Donor Registry functions by making available 
information on (A) the resources available through the Donor 
Registry Program, (B) the comparative costs incurred by 
patients prior to transplant, and (C) the marrow donor 
registries that meet the standards described in paragraphs (3) 
and (4) of subsection (c), to assist patients, their families, 
and their physicians in the search for an unrelated marrow 
donor.
          * * * * * * *
    [(4) provide information to physicians, other health care 
professionals, and the public regarding bone marrow 
transplantation;]
    (4) provide information to physicians, other health care 
professionals and the public regarding the availability of 
unrelated marrow transplantation as a potential treatment 
option;]
    [(5) recruit bone marrow donors;]
    (5) establish a program for the recruitment of new bone 
marrow donors that includes--
          (A) the priority to increase potential marrow donors 
        for which there is a greater degree of marrow donor 
        shortage than that of the general population; and
          (B) the compilation and distribution of informational 
        materials to educate and update potential donors;
    (6) annually update the Donor Registry to account for 
changes in potential donor status;
    (7) not later than 1 year after the date on which the `Bone 
Marrow Program Inspection' (hereafter referred to in this part 
as the `Inspection') that is being conducted by the Office of 
the Inspector General on the date of enactment of this 
paragraph is completed, in consultation with the Secretary, and 
based on the findings and recommendations of the Inspection, 
the marrow donor program shall develop, evaluate, and implement 
a plan to streamline and make more efficient the relationship 
between the Donor Registry and donor centers;
    [(6)] (8) collect, analyze, and publish data concerning 
bone marrow donation and transplantation; and
    [(7)] (9) support studies and demonstration projects for 
the purpose of increasing the number of individuals, especially 
minorities, who are willing to be marrow donors.
          * * * * * * *
    [(j) Authorization of appropriations. There are authorized 
to be appropriated to carry out this section $15,000,000 for 
fiscal year 1991 and such sums as may be necessary for each of 
fiscal years 1992 and 1993.]
    (j) Information and Education Program.--
          (1) In general.--The Secretary may enter into 
        contracts with, public or nonprofit private entities 
        for the purpose of increasing unrelated allogeneic 
        marrow transplants, by enabling such entities to--
                  (A) plan and conduct programs to provide 
                information and education to the professional 
                health care community on the availability of 
                unrelated allogeneic marrow transplants as a 
                potential treatment option;
                  (B) plan and conduct programs to provide 
                information and education to the public on the 
                availability of unrelated donor marrow 
                transplants and the need for donations of bone 
                marrow;
                  (C) train individuals in requesting bone 
                marrow donations; and
                  (D) recruit, test and enroll marrow donors 
                with the priority being groups for which there 
                is a greater degree of marrow donor shortage 
                than that of the general population.
          (2) Priorities.--In awarding contracts under 
        paragraph (1), the Secretary shall give priority to 
        carrying out the purposes described with respect to 
        population groups with such shortages.
    (k) Patient Advocacy and Case Management.--
          (1) Establishment.--The Donor Registry shall 
        establish and maintain an office of patient advocacy 
        and case management that meets the requirements of this 
        subsection.
          (2) Functions.--The office established under 
        paragraph (1) shall--
                  (A) be headed by a director who shall serve 
                as an advocate on behalf of--
                          (i) individuals who are registered 
                        with the Donor Registry to search for a 
                        biologically unrelated bone marrow 
                        donor;
                          (ii) the physicians involved; and
                          (iii) individuals who are included in 
                        the Donor Registry as potential marrow 
                        donors;
                  (B) establish and maintain a system for 
                patient advocacy that directly assists 
                patients, their families, and their physicians 
                in a search for an unrelated donor;
                  (C) provide individual case management 
                services as appropriate to directly assist 
                individuals and physicians referred to in 
                subparagraph (A), including--
                          (i) individualized case assessment 
                        and tracking of preliminary search 
                        through activation (including when the 
                        search process is interrupted or 
                        discontinued);
                          (ii) informing individuals and 
                        physicians on regular intervals of 
                        progress made in searching for 
                        appropriate donors; and
                          (iii) identifying and resolving 
                        individual search problems or concerns;
                  (D) collect and analyze data concerning the 
                number and percentage of individuals proceeding 
                from preliminary to formal search, formal 
                search to transplantation, the number and 
                percentage of patients unable to complete the 
                search process, and the comparative costs 
                incurred by patients prior to transplant;
                  (E) survey patients to evaluate how well such 
                patients are being served and make 
                recommendations for expediting the search 
                process; and
                  (F) provide individual case management 
                services to individual marrow donors.
          (3) Evaluation.--
                  (A) In general.--The Secretary shall evaluate 
                the system established under paragraph (1) and 
                make recommendations concerning the success or 
                failure of such system in improving patient 
                satisfaction, and any impact the system has had 
                on assisting individuals in proceeding to 
                transplant.
                  (B) Report.--Not later than April 1, 1996, 
                the Secretary shall prepare and make available 
                a report concerning the evaluation conducted 
                under subparagraph (A), including the 
                recommendations developed under such 
                subparagraph.
          * * * * * * *

[SEC. 379A. STUDY BY GENERAL ACCOUNTING OFFICE

    [(a) In general. The Comptroller General of the United 
States shall conduct a study that evaluates--
          [(1) the costs and benefits of the search process for 
        an unrelated bone marrow donor among different marrow 
        donor registries;
          [(2) the extent to which marrow donor registries 
        protect donor confidentiality;
          [(3) the relationship between the Registry, 
        individual marrow donor centers, and other marrow donor 
        registries;
          [(4) the effectiveness and appropriateness of 
        policies and procedures of marrow donor centers, marrow 
        transplant centers, and marrow donor registries, 
        including--
                  [(A) the process of donor recruitment, 
                including the policy of asking each donor 
                whether the donor would want to donate more 
                than one time;
                  [(B) the maintenance and updating of donor 
                files; and
                  [(C) the policy of initially typing donors 
                for A/B antigens only instead of initially 
                typing for both A/B and D/R antigens;
          [(5) the ability of the marrow donor registries to 
        incorporate changes in medical research and clinical 
        practice; and
          [(6) the costs associated with tissue typing.
    [(b) Report.--Not later than 1 year after the date of 
enactment of this part, the Comptroller General shall complete 
the study required under subsection (a) and submit to the 
Committee on Energy and Commerce of the House of 
Representatives and the Committee on Labor and Human Resources 
of the Senate a report describing the findings made by the 
study and recommendations for legislative reform.]

SEC. 379A. STUDIES, EVALUATIONS AND REPORTS.

    (a) Evaluation by the Institute of Medicine.--
          (1) In general.--The Secretary shall enter into a 
        contract with a public or nonprofit private entity to 
        conduct a study and evaluation of--
                  (A) the role of a national bone marrow 
                transplant program supported by the Federal 
                Government in facilitating the maximum number 
                of unrelated marrow donor transplants; and
                  (B) other possible clinical or scientific 
                uses of the potential donor pool or 
                accompanying information maintained by the 
                Donor Registry or the unrelated marrow donor 
                scientific registry.
          (2) Institute of medicine.--The Secretary shall 
        request the Institute of Medicine of the National 
        Academy of Sciences to enter into the contract under 
        paragraph (1) to conduct the study and evaluation 
        described in such paragraph. If the Institute declines 
        to conduct the study and evaluation under such 
        paragraph, the Secretary shall carry out such 
        activities through another public or nonprofit private 
        entity.
          (3) Report.--Not later than 2 years after the date of 
        enactment of this section, the Institute of Medicine 
        (or other entity as the case may be) shall complete the 
        study required under paragraph (1) and prepare and 
        submit to the Committee on Labor and Human Resources of 
        the Senate, a report describing the findings made as a 
        result of the study.
    (b) Bone Marrow Consolidation.--
          (1) In general.--The Secretary shall conduct--
                  (A) an evaluation of the feasibility of 
                integrating or consolidating all federally 
                funded bone marrow transplantation scientific 
                registries, regardless of the type of marrow 
                reconstitution utilized; and
                  (B) an evaluation of all federally funded 
                bone marrow transplantation research to be 
                conducted under the direction and 
                administration of the peer review system of the 
                National Institutes of Health.
          (2) Report.--Not later than 1 year after the date of 
        enactment of this section, the Secretary shall prepare 
        and submit to the Committee on Labor and Human 
        Resources of the Senate a report concerning the 
        evaluations conducted under paragraph (1).
          (3) Definition.--As used in paragraph (1), the term 
        `marrow reconstitution' shall encompass all sources of 
        hematopoietic cells including marrow (autologous, 
        related and unrelated allogeneic, syngeneic), 
        autologous marrow, allogeneic marrow (biologically 
        related or unrelated), umbilical cord blood cells, 
        peripheral blood progenitor cells, or other approaches 
        that may be utilized.

SEC. 379B. BONE MARROW SCIENTIFIC REGISTRY.

    (a) Establishment.--The Secretary, acting through the Donor 
Registry, shall establish and maintain a bone marrow scientific 
registry of all recipients of biologic unrelated allogeneic 
marrow donors.
    (b) Information.--The bone marrow transplantation 
scientific registry established under subsection (a) shall 
include information with respect to patients who have received 
biologic unrelated allogeneic marrow transplant, transplant 
procedures, pretransplant and transplant costs, and other 
information the Secretary determines to be necessary to conduct 
an ongoing evaluation of the scientific and clinic status of 
unrelated allogeneic marrow transplantation.
    (c) Report.--The Donor Registry shall submit to the 
Secretary on an annual basis a report using data collected and 
maintained by the bone marrow transplantation scientific 
registry established under subsection (a) concerning patient 
outcomes with respect to each transplant center and the 
pretransplant comparative costs involved at such transplant 
centers.

SEC. 379C. AUTHORIZATION OF APPROPRIATIONS.

    There are authorized to be appropriated to carry out 
section 379, $13,500,000 for fiscal year 1997, $12,150,000 for 
fiscal year 1998, and such sums as may be necessary for fiscal 
year 1999.

                                
