[Congressional Record Volume 146, Number 45 (Tuesday, April 11, 2000)]
[Senate]
[Pages S2534-S2541]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. FITZGERALD (for himself, Mr. Schumer, Mr. Durbin, Mr. 
        Santorum, Mr. Specter, Ms. Mikulski, Mr. Sarbanes, and Mr. 
        Kerrey):
  S. 2398. A bill to amend the Public Health Service Act to revise and 
extend the programs relating to organ procurement and transplantation; 
to the Committee on Health, Education, Labor, and Pensions.


               organ transplantation fairness act of 2000

  Mr. FITZGERALD. Thank you, Mr. President.
  Mr. President, I rise today to introduce the Organ Transplantation 
Fairness Act of 2000.
  I thank my original cosponsors on this bill: Senators Schumer, 
Durbin, Santorum, Specter, Mikulski, Sarbanes, and Kerrey.
  Our Nation's organ procurement and transplant system is in serious 
need of change.
  We could be saving more lives through organ transplants in this 
country than we are at the present time.
  The purpose of our bill and the goals of our bill are threefold.
  First, we want to increase the amount of organs that are being 
donated all across the country.
  There are many more people who need to receive organs to remain 
alive. They need organ transplants, and there are not a sufficient 
number of people donating those organs. This bill attempts to address 
that issue.
  Second, we want to bring greater fairness to how we allocate scarce 
organs after they are donated.
  Right now those organs are not allocated in the best possible way. 
And because of problems in our allocation system, people are dying 
unnecessarily. We could be saving more lives.
  The third goal of the bill is to seek to implement many of the 
recommendations of the Institute of Medicine in

[[Page S2536]]

their 1999 report entitled ``Organ Procurement and Transplantation.''
  In attempting to improve the system of organ procurement transplants 
in this country, we have picked out many of the Institute of Medicine's 
recommendations, and we tried to enact them into law. Our system is 
saving many more lives than it used to.
  Organ transplantation is fairly new to this country. If you go back 
20 years or so, there were very few organs being transplanted. But now 
many more people are benefiting and going on to live healthy lives 
thanks to people who have donated organs, and thanks to successful 
transplants. But as many lives as our system has saved, we are not 
saving as many lives as we could.
  I have a chart to demonstrate this. As of today, there are over 
68,000 American patients waiting for a life-saving organ transplant.
  In 1998, the most recent statistics available, over 4,800 people died 
while on that organ transplant waiting list.
  That means about 13 people a day are dying in this country while 
waiting to get an organ that can be transplanted into their bodies.
  I said earlier that we are not saving as many lives as we could save.
  Let me demonstrate why that is the case, and why we know we are not 
saving enough lives.
  According to the Department of Health and Human Services, in 1998, 
some 71 percent of livers were transplanted to patients in the least 
urgent medical status categories. But at the same time that we were 
transplanting those livers into patients in the least urgent medical 
status categories, in the same year, 1,300 patients died while waiting 
for a liver.
  How can it be that we are transplanting livers into patients who 
aren't in the most critically ill categories, while at the same time 
people in the most critical condition were dying for lack of a liver 
transplant?
  The reason for that is we have a system in our country that is based 
on where you live. Whether you live or die because of an organ 
transplant may depend not on how sick you are but on where you live in 
this country.
  Let's examine this a little bit more closely.
  There is a private not-for-profit corporation in this country that 
has been given the authority to be in charge of our Nation's organ 
transplant and procurement network. They have set up a series of 
regions. They divided the whole country into regions. There are organs 
that are available within those regions. But if you live outside one of 
the regions where an organ is available, you are not liable to get one 
of the organs when it comes up.

  As a Senator from Illinois, I think the simplest thing for me to do 
in illustrating this problem is to use Illinois as an example. Most of 
Illinois is in organ procurement organization district 29. You can have 
a patient who lives in northern Illinois, just a few miles from the 
border of Wisconsin, and this patient could need a liver transplant. He 
or she could be in status 1 medical condition, which means he or she is 
in the most critical category and in need of a liver transplant 
immediately. A liver may become available just over the border in 
region 37, the Wisconsin network. But that liver can't be sent to the 
person in Illinois because that person in Illinois is in region 29--not 
37.
  If a liver becomes available from a donor in Wisconsin, they will 
first look to see if they have a very critically ill person who needs a 
liver transplant in region 37. If they don't find such a person, then 
they will go to somebody who is in a less urgent situation who doesn't 
need the liver as quickly as that other person in Illinois. Thus, 
somebody who may be in status 2, or even what they call status 3 
medical condition, which isn't as critical as status 1, could get the 
liver transplant up in Wisconsin. But that person a few miles south of 
the border who needs the liver immediately, because he or she happens 
to live in Illinois, cannot get it. If an organ doesn't become 
available in that region in which he or she lives, that person may not 
survive.
  There is a saying in the real estate industry by the real estate 
brokers and agents. When you go to them, they always tell you that 
everything and the value of your home depends on ``location, location, 
location.'' I bet not many Americans realize that in some cases if you 
are in need of a liver transplant or a heart transplant, your chances 
of survival are going to depend on your location, your location, your 
location.
  The purpose of our bill is to try to open this system up, and instead 
of directing the organs to the people depending on where they live, 
instead of determining whether people are going to live or die simply 
based on accidents of geography, we try to bring sense to this whole 
system. We try to get organs to people in the most critical need of 
those organs as soon as possible. We would hope to get those to the 
sickest people as soon as possible--the sickest people who have the 
chance of going on and having a successful transplant.
  There comes a point when your organs are so damaged and you are so 
sick that it could be that a transplant would no longer help you. 
Certainly, we have to be careful to make sure that we get the organs to 
those who are the sickest but who still have a good chance of surviving 
an organ transplant.
  In addition, attempting to get the organs to the sickest patients 
first, making that our Nation's public policy, we would like to 
encourage a broader sharing of organs.
  The Institute of Medicine's report suggested that each of these areas 
should contain at least 9 million people. That is the minimum level for 
optimal sharing to get the organs out and save the most lives. We want 
to make sure we broaden these networks.

  It isn't possible in all cases for all organs to be shared 
nationally. With the heart, for example, a heart cannot last much more 
than 4 hours after it has been given by a donor. It has to be 
transplanted quickly. Other organs, such as kidneys, my understanding 
is we can preserve them for over 24 hours, or even longer, and in that 
circumstance it would be possible to have more nationwide sharing to 
get those organs allocated to the people who need them the most.
  Another important provision of our legislation is to take a strong 
stand for the proposition that the private not-for-profit corporation 
that now runs the whole Nation's organ procurement and transplant 
network should have some public accountability. Members may have heard 
that a bill passed by the House of Representatives provides no public 
accountability for this private corporation that has life or death 
control over at least 68,000 Americans. There is no accountability in 
that bill. They wouldn't be accountable to elected officials. They 
could not be regulated by the Department of Health and Human Services. 
If people had a complaint with how that organization was being run, 
there would be little or no recourse. I guess you could knock on their 
doors at their corporate headquarters in Richmond, VA, and ask them to 
listen to you, but they wouldn't have to. They are private not-for-
profit corporations with no responsibility to make sure the best public 
policy goals of this country are achieved.
  I don't think that is right. I think we want this corporation to be 
publicly accountable to make sure that it is meeting the objectives of 
the laws that are on the books and serving the public interest.
  In addition, the Organ Transplantation Fairness Act of 2000 would 
create a national organ transplant advisory board. It implements the 
recommendations of the Institute of Medicine in this regard by creating 
an advisory board that reviews the organ procurement and 
transplantation network policies and advises the Secretary of our 
Department of Health and Human Services.
  We also put in place a process, based on sound medical criteria, for 
the certification and recertification of what they call OPOs--organ 
procurement organizations. It requires the OPOs that fail to meet 
performance criteria to file a corrected plan, and they will have 3 
years to implement such a plan. We have to have a way of making sure 
the organ procurement organizations in this country are doing a good, 
professional job. There has to be some accountability of those 
organizations.
  One of the most important issues, of course, is encouraging more 
organ donations. Earlier this morning I had the opportunity to meet in 
my office with several individuals who had actually been the recipients 
of donated organs. Those transplants they had had saved

[[Page S2537]]

their lives. One of them was a constituent of mine. His name was Kent 
Schlink from Peoria, IL. When Kent was in his late twenties, he had to 
have a heart transplant to correct a defect he had in his heart dating 
from his early childhood. He was very sick. He was on the waiting list 
for quite some time. He ultimately had a heart transplant at St. 
Francis Hospital in Peoria, IL, that saved his life. His life was saved 
at a time when he had a 6-month-old child. He has gone on to have 
another child. To see him talk about the joy to be with his young kids 
drives home what a gift people who donate organs make--a gift of life.
  We also had the opportunity to meet in my office with Britney Green, 
a young girl whom I believe is 13 years old. She had a liver transplant 
when she was 3 years old. She is currently on a waiting list for a new 
heart. She has had a very tough road to hoe, but she is a bright and 
cheerful young lady. She is very supportive and hopes we can improve 
the system in this country.
  Finally, I wish to mention one other young man who impressed me. His 
name is Danny Canal. Danny is 14 years old, and he is an incredibly 
bright, wonderful young man. He is a transplant recipient who actually 
had a four-organ transplant, if you can believe that. Not only did he 
have four organs transplanted, he actually had two sets of those organs 
before the third set began functioning properly. This wonderful young 
kid who has been saved by these organ transplants probably wouldn't 
have had to have so many organs transplanted into him, because he 
originally only needed a transplant of a small intestine. 
Unfortunately, it took so long, he was on the waiting list for the 
transplant of that intestine so long that his other organs started to 
fail, to the point where he had to have his pancreas and other organs 
replaced. Then there were problems and it took three times before they 
got that right. He is a wonderful young man. It was a very moving 
experience to hear his story.

  We need to encourage more people to donate organs so there can be 
more Danny Covals and Kent Schlinks and Britney Greens whose lives can 
be saved in this country. Our bill does a lot to address that. We seek 
to establish a grant program to assist organ procurement organizations 
and other not-for-profit organizations in developing and expanding 
programs aimed at increasing organ donation rates.
  We create a congressional donor medal to honor living organ donors 
and organ donor families, and give credit to the tremendous gift they 
are giving by giving an organ. We establish a system of support for 
State programs to increase organ donation, and we provide some 
financial support to pay for nonmedical travel expenses of living 
donors.
  We have long had a transplant policy in this country that it was 
against public policy, against the law to pay people for donating 
organs. That creates many medical and ethical issues. I agree with that 
prohibition against paying people for donating organs. Everybody who 
does it is doing it just for the internal reward of helping somebody 
else. They are not doing it for any financial gain. However, I think it 
is appropriate that we could at least help defray some of the 
nonmedical travel expenses of the living donors. Most health insurance 
policies do, in fact, now in this country cover the medical expenses 
associated with donating the organ.
  The bill also bans lobbying by the organ procurement and transplant 
network administrator. That is the private not-for-profit corporation 
in Richmond, VA. We prohibit that firm which administers the program 
under contract with the Department of Health and Human Services from 
using fees that it collects from transplant patients to lobby Members 
of Congress. That firm is collecting, I believe, $375 from every person 
who is on an organ donor waiting list in the country. We want to make 
sure those fees are helping to match organs with patients so that more 
people can be saved. We do not think they need to be using those funds 
to lobby Members of Congress.

  Finally, one of the things the bill does is it actually comes in and 
abolishes State laws that are on the books in several States that are 
referred to as organ hoarding laws. Several States now, I regret to 
say, have enacted laws saying organs donated within their State borders 
cannot be given to people outside of their States. One of those States 
is the State of Wisconsin, that borders on my State of Illinois.
  I love Wisconsin. I think it is one of the most beautiful States in 
our country. Every summer my family and I go up and we vacation in 
northern Wisconsin. We enjoy their fishing and beautiful forests and 
the wildlife there. But I disagree with the law they have on the books 
that says if somebody in Wisconsin donates an organ, it cannot save a 
life in Illinois. I know Walter Payton, if he could have had an organ 
donated from a Green Bay Packer fan, would have gladly accepted it.
  We do not need to be engaging in the Balkanization of our country. We 
do not need to have these kinds of barriers erected between States. We 
are, in the end, one nation, one giant state. This Balkanization has no 
place in our country. A report from the Institute of Medicine and other 
reports have indicated the statutes on the books in these several 
States greatly diminish the effectiveness and equity of a national 
organ transplant policy. We need to make sure that is no longer 
allowed.
  The other thing I point out is many of the people from Wisconsin may 
come down and get listed on a transplant list at a hospital in Chicago. 
Then the effect of that law, passed by the Wisconsin legislature, would 
be to deny their own resident of the State of Wisconsin the ability to 
get the transplant at maybe a very renowned hospital in Chicago, or 
even one they go to in New York or another big State. That is 
inappropriate. It is not good public policy. Our bill would very firmly 
say that those laws would no longer be allowed in the States, and I 
think we would be on our way toward developing a much better national 
policy.
  With that, Mr. President, I ask unanimous consent that the text of my 
bill be printed in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 2398

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Organ Transplantation 
     Fairness Act of 2000''.

     SEC. 2. FINDINGS.

       (a) In General.--Congress makes the following findings:
       (1) It is in the public interest to maintain and 
     continually improve a national network to ensure the fair and 
     effective distribution of organs among patients on the 
     national waiting list irrespective of their place of 
     residence or the location of the transplant program with 
     which they are listed, and to ensure quality and facilitate 
     collaboration among network members and individual medical 
     practitioners participating in the network activities.
       (2) The Organ Procurement and Transplantation Network 
     (referred to in this section as the ``Network'') was created 
     in 1984 by the National Organ Transplant Act (Public Law 98-
     507) in order to facilitate an equitable allocation of organs 
     among all patients on a national basis.
       (3) The Federal Government should continue to provide 
     Federal oversight of the Network and is responsible for 
     protecting the public's health care interest and ensuring 
     that the policies of the Network meet the goals established 
     by this Act.
       (4) The responsibility for developing, establishing, and 
     maintaining medical criteria and standards for organ 
     procurement and transplantation should be a function of the 
     Network, and the Secretary of Health and Human Services 
     should provide oversight to ensure compliance with this Act 
     and other applicable laws.
       (5) The network should be operated by a private 
     organization under contract with the Department of Health and 
     Human Services.
       (6) The Federal Government is responsible for ensuring that 
     the efforts of the Network serve patients and donor families 
     in the procurement and distribution of organs.
       (7) The Federal Government should take immediate action to 
     improve organ donation rates and increase the number of 
     organs available for transplantation.
       (8) There is a significant disparity between the number of 
     organ donors and the number of individuals waiting for organ 
     transplants, and it is in the public's best interest to have 
     a system of organ allocation that ensures that transplant 
     candidates with similar severity of illness have similar 
     likelihood of transplantation irrespective of their place of 
     residence or the location of the transplant program with 
     which they are listed.
       (b) Sense of Congress Regarding Organ Donation.--It is the 
     sense of Congress that--
       (1) the factors that impact organ donation rates are 
     complex and require a multifaceted approach to increase organ 
     donation rates;
       (2) the Federal Government should lead the national effort 
     to increase organ donation

[[Page S2538]]

     and develop programs with the transplant community to 
     research and implement a best practices approach to 
     increasing organ donation; and
       (3) a generous contribution has been made by each 
     individual who has donated an organ to save a life.

     SEC. 3. ORGAN PROCUREMENT ORGANIZATIONS.

       Section 371 of the Public Health Service Act (42 U.S.C. 
     273) is amended to read as follows:

     ``SEC. 371. ORGAN PROCUREMENT ORGANIZATIONS.

       ``(a) Authority of the Secretary.--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.
       ``(b) Qualified Organizations.--
       ``(1) Requirements.--A qualified organ procurement 
     organization for which grants may be made under subsection 
     (a) is an organization that, as determined by the Secretary, 
     will carry out the functions described in paragraph (2), and 
     that--
       ``(A) is a nonprofit entity;
       ``(B) has accounting and other fiscal procedures (as 
     specified by the Secretary) necessary to ensure the fiscal 
     stability of the organization;
       ``(C) has an agreement with the Secretary to be reimbursed 
     under title XVIII of the Social Security Act for the 
     procurement of kidneys;
       ``(D) notwithstanding any other provision of law, has met 
     the other requirements of this subsection and has been 
     certified or recertified by the Secretary as meeting the 
     performance standards to be a qualified organ procurement 
     organization through a process that--
       ``(i) granted certification or recertification within the 
     previous 4 years with such certification in effect as of 
     October 1, 2000, and remaining in effect through the earlier 
     of--

       ``(I) January 1, 2002; or
       ``(II) the completion of recertification under the 
     requirements of clause (ii); or

       ``(ii) is set forth in regulations prescribed by the 
     Secretary not later than January 1, 2002, that--

       ``(I) require recertifications of qualified organ 
     procurement organizations not more frequently than once every 
     4 years;
       ``(II) rely on outcome and process performance measures 
     that are based on available, practical empirical evidence of 
     organ donor potential or other related factors in each 
     service area of qualified organ procurement organizations;
       ``(III) use multiple outcome measures as part of the 
     certification process;
       ``(IV) provide for the filing and approval of a corrective 
     action plan by a qualified organ procurement organization if 
     the Secretary notifies the organ procurement organization 
     that it has failed to meet the performance measures after the 
     first 2 years of the 4 year certification period, which 
     corrective action plan shall apply for the 3 years following 
     approval of such plan;
       ``(V) provide for a qualified organ procurement 
     organization to appeal a decertification to the Secretary on 
     substantive and procedural grounds;

       ``(E) has procedures to obtain payment for nonrenal organs 
     provided to transplant centers;
       ``(F) has a defined service area that is of sufficient size 
     to assure maximum effectiveness in the procurement of organs;
       ``(G) has a director and other such staff, including the 
     organ donation coordinators and organ procurement specialists 
     necessary to effectively obtain organs from donors in its 
     service area; and
       ``(H) has a board of directors or an advisory board that--
       ``(i) is composed of--

       ``(I) members who represent hospital administrators, 
     intensive care or emergency room personnel, tissue banks, and 
     voluntary health organizations in its service area;
       ``(II) members who represent the public residing in such 
     area;
       ``(III) a physician with knowledge, experience, or skill in 
     the field of histocompatibility or an individual with a 
     doctorate degree in biological science with knowledge, 
     experience, or skill in the field of histocompatibility;
       ``(IV) a physician with knowledge or skill in the field of 
     neurology; and
       ``(V) from each transplant center in its service area, a 
     member who is a surgeon who has practicing privileges in such 
     center and who performs organ transplant surgery;

       ``(ii) has the authority to recommend policies for the 
     procurement of organs and the other functions described in 
     paragraph (2); and
       ``(iii) has no authority over any other activity of the 
     organization.
       ``(2) Functions.--An organ procurement organization shall--
       ``(A) have effective agreements, to identify potential 
     organ donors, with all of the hospitals and other health care 
     entities in its service area that have facilities for organ 
     donation;
       ``(B) conduct and participate in systematic efforts, 
     including professional education, to acquire all usable 
     organs from potential donors;
       ``(C) 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)(F), 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) arrange for the appropriate tissue typing of donated 
     organs;
       ``(E) assist the Organ Procurement and Transplantation 
     Network in the equitable distribution of organs among 
     patients on a national basis;
       ``(F) provide or arrange for the transportation of donated 
     organs to transplant centers;
       ``(G) have arrangements to coordinate its activities with 
     transplant centers in its service area;
       ``(H) participate in the Organ Procurement and 
     Transplantation Network established under section 372;
       ``(I) 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 usable tissues are obtained from potential donors;
       ``(J) evaluate annually the effectiveness of the 
     organization in acquiring potentially available organs; and
       ``(K) assist hospitals in establishing and implementing 
     protocols for assuring that all deaths and imminent deaths 
     are reported to the appropriate organ procurement 
     organization.''.

     SEC. 4. ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK.

       Section 372 of the Public Health Service Act (42 U.S.C. 
     274) is amended to read as follows:

     ``SEC. 372. ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK.

       ``(a) In General.--The Secretary shall by regulation 
     provide for the establishment and operation of an Organ 
     Procurement and Transplantation Network that meets the 
     requirements of subsection (b).
       ``(b) Requirements.--
       ``(1) In general.--The Organ Procurement and 
     Transplantation Network shall carry out the functions 
     described in paragraph (2) and shall--
       ``(A) be operated by a private entity under contract with 
     the Department of Health and Human Services; and
       ``(B) have a board of directors--
       ``(i) not more than 50 percent of which members are 
     transplant surgeons or transplant physicians;
       ``(ii) at least 25 percent of which members are transplant 
     candidates, transplant recipients, organ donors, and family 
     members; and
       ``(iii) that includes representatives of organ procurement 
     organizations, voluntary health associations, and the general 
     public; and
       ``(iv) that shall establish an executive committee and 
     other committees, whose chairpersons shall be selected to 
     ensure continuity of the board.
       ``(2) Functions.--The Organ Procurement and Transplantation 
     Network shall--
       ``(A) establish and maintain one or more lists derived from 
     a national list of individuals who need organ transplants;
       ``(B) establish a national system, through the use of 
     computers and in accordance with established medical 
     criteria, to match organs and individuals included on such 
     lists;
       ``(C) establish membership criteria for hospitals, for 
     performing organ transplants, and for individual members;
       ``(D) maintain a 24-hour telephone service to facilitate 
     matching organs with individuals included in such lists;
       ``(E) allocate organs so that transplant candidates with 
     similar severity of illness have similar likelihood of 
     receiving a transplant irrespective of their place of 
     residence or the location of the transplant program with 
     which they are listed;
       ``(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;
       ``(G) prepare and distribute, on a national basis, samples 
     of blood sera from individuals who are included on such lists 
     in order to facilitate matching the compatibility of such 
     individuals with organ donors;
       ``(H) coordinate, as appropriate, the transportation of 
     organs from organ procurement organizations to transplant 
     centers;
       ``(I) provide information to physicians and other health 
     professionals and the general public regarding organ 
     donation;
       ``(J) collect, analyze, and publish data concerning organ 
     donation and transplants;
       ``(K) provide data to the Secretary in order to permit the 
     Secretary to carry out the Secretary's responsibilities under 
     this part, and to the Scientific Registry maintained pursuant 
     to section 373;
       ``(L) respond in a timely fashion and to the extent 
     permitted, to requests for data from researchers and 
     investigators;
       ``(M) carry out studies and demonstration projects for the 
     purpose of improving procedures for organ procurement and 
     allocation;
       ``(N) work actively to increase the supply of donated 
     organs;
       ``(O) submit to the Secretary an annual report containing 
     information on the comparative costs and patient outcomes at 
     each transplant center affiliated with the Organ Procurement 
     and Transplantation Network; and
       ``(P) submit to the Secretary an annual report containing 
     such financial information,

[[Page S2539]]

     as determined by the Secretary, to be necessary to evaluate 
     the cost of operating the Organ Procurement and 
     Transplantation Network.
       ``(3) Availability of patient listing fees and 
     participation fees.--
       ``(A) In general.--Any fees described in subparagraph (B) 
     that are collected by the Organ Procurement and 
     Transplantation Network--
       ``(i) shall be available to the Organ Procurement and 
     Transplantation Network, without fiscal year limitation, for 
     use in carrying out the functions of the Organ Procurement 
     Transplantation Network under this section; and
       ``(ii) shall not be used for any activity (including 
     lobbying or other political activity) that is not authorized 
     under this section.
       ``(B) Covered fees.--Subparagraph (A) applies with respect 
     to the following:
       ``(i) Listing fees.
       ``(ii) Fees imposed as a condition of being a participant 
     in the Organ Procurement and Transplantation Network.
       ``(C) Construction.--No provision of this paragraph may be 
     construed to prohibit the Organ Procurement and 
     Transplantation Network from--
       ``(i) collecting fees other than the fees described in 
     subparagraph (B); or
       ``(ii) using fees covered by clause (i) for an activity 
     covered by subparagraph (A)(ii) or other activity.
       ``(c) Organ Allocation.--
       ``(1) Development of policies.--The Organ Procurement and 
     Transplantation Network shall develop organ-specific policies 
     (including combinations of organs, such as for kidney-
     pancreas transplants), subject to the review of and approval 
     by the Secretary, for the equitable allocation of cadaveric 
     organs to individuals on the national waiting list.
       ``(2) Listing criteria.--Standardized minimum listing 
     criteria for including individuals on the national list shall 
     be established and, to the extent possible, shall--
       ``(A) contain explicit thresholds for the listing of a 
     patient;
       ``(B) avoid futile transplants or the wasting of organs;
       ``(C) be expressed through objective and measurable medical 
     criteria; and
       ``(D) be reviewed periodically and revised as appropriate.
       ``(3) Requirements relating to transplant candidates.--
     Where appropriate for the specific organ, transplant 
     candidates shall--
       ``(A) be grouped by status categories from most to least 
     medically urgent with--
       ``(i) sufficient categories to avoid grouping together 
     individuals with substantially different medical urgency;
       ``(ii) explicit thresholds for differentiating among 
     patients; and
       ``(iii) explicit standards for the movement of individuals 
     among the status categories;
       ``(B) be expressed through objective and measurable medical 
     criteria; and
       ``(C) be reviewed periodically and revised as appropriate.
       ``(4) Requirements for allocation policies and 
     procedures.--Organ allocation policies and procedures shall 
     be established in accordance with sound medical judgment and 
     shall--
       ``(A) be designed and implemented to allocate organs among 
     transplant candidates--
       ``(i) in order of decreasing medical urgency status;
       ``(ii) over the largest geographic area practicable in a 
     manner consistent with organ viability so that neither place 
     of residence nor place of listing shall be a major 
     determinant; and
       ``(iii) so as to maintain organ viability and avoid organ 
     wastage; and
       ``(B) be reviewed periodically and revised as appropriate.
       ``(5) Policies where medical urgency is not an appropriate 
     measurement.--Where medical urgency is not an appropriate 
     measurement for organ allocation, policies and procedures 
     shall be established in accordance with sound medical 
     judgment.
       ``(d) Authority of the Secretary.--The policies and rules 
     established by the Organ Procurement and Transplantation 
     Network that are to be enforceable shall be subject to review 
     and approval by the Secretary. The Secretary shall--
       ``(1) in consultation with the Organ Procurement and 
     Transplantation Network, develop mechanisms to promote and 
     review compliance with the requirements of this section;
       ``(2) establish and approve all fees, dues, or similar 
     costs charged to support the operation of the Organ 
     Procurement and Transplantation Network;
       ``(3) establish procedures for receiving from 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
       ``(4) take such action, as determined by the Secretary, to 
     enforce the requirements of this section as well as the 
     requirements under title XVIII of the Social Security Act.
       ``(5) if the Organ Procurement and Transplantation Network 
     fails to submit a policy on a matter which the Secretary 
     determines should be enforced under this section or section 
     1138 of the Social Security Act, or the Organ Procurement and 
     Transplantation Network submits a policy that the Secretary 
     determines is inconsistent with the goals of this Act, submit 
     to the board of directors or advisory board of the Organ 
     Procurement and Transplantation Network the Secretary's 
     version of such policy.
       ``(e) National Transplant Advisory Board.--
       ``(1) Establishment.--The Secretary shall, by regulation, 
     provide for the establishment of a National Organ Transplant 
     Advisory Board (referred to in this subsection as the 
     `Board').
       ``(2) Membership.--The Board shall carry out the functions 
     described in paragraph (3) and shall be comprised of 
     individuals that--
       ``(A) include a broad spectrum of representatives of the 
     medical and scientific community, including transplant 
     surgeons, transplant physicians, epidemiologists, and health 
     service researchers, as well as representatives from organ 
     procurement organizations and the community of transplant 
     patients, family members and donor families;
       ``(B) are selected by the Secretary;
       ``(C) serve terms of not less than 3 years.
       ``(3) Functions.--The Board shall assist the Secretary in 
     ensuring that the Organ Procurement and Transplantation 
     Network is grounded on the best available medical science and 
     is effective and equitable as possible and shall--
       ``(A) at the request of the Secretary, review the policies 
     and rules of the Organ Procurement and Transplantation 
     Network;
       ``(B) advise and propose to the Secretary policies, rules, 
     and regulations affecting organ procurement and 
     transplantation;
       ``(C) at the request of the Secretary, review and consider 
     policies and regulations affecting organ transplantation 
     developed by the Secretary;
       ``(D) advise the Secretary with respect to comments 
     received by the Secretary under subsection (d)(3);
       ``(E) meet at the request of the Secretary, but not less 
     than 2 times each year; and
       ``(F) elect a Chairperson and Vice-chairperson as well as 
     any other officers as determined appropriate by the Board.
       ``(4) Authorization of appropriations.--For the purpose of 
     carrying out this subsection, there are authorized to be 
     appropriated $1,000,000 for each of the fiscal years 2000 
     through 2005.''.

     SEC. 5. SCIENTIFIC REGISTRY.

       Section 373 of the Public Health Service Act (42 U.S.C. 
     274a) is amended to read as follows:

     ``SEC. 373. SCIENTIFIC REGISTRY.

       ``The Secretary shall, by grant or contract, develop and 
     maintain a scientific registry of the recipients of organ 
     transplants. The registry shall include such information 
     concerning patients and transplant procedures as the 
     Secretary determines to be necessary to an ongoing evaluation 
     to the scientific and clinical status of organ 
     transplantation. The registry shall also include such 
     information concerning both donors and patients in 
     transplants involving living donors. The Secretary shall 
     prepare for inclusion in the report under section 376 an 
     analysis of information derived from the registry.''.

     SEC. 6. ADMINISTRATION.

       Section 375 of the Public Health Service Act (42 U.S.C. 
     274c) is amended to read as follows:

     ``SEC. 375. ADMINISTRATION.

       ``The Secretary shall designate and maintain an 
     identifiable administrative unit in the Public Health Service 
     to--
       ``(1) administer this part and coordinate with organ 
     procurement activities under title XVIII of the Social 
     Security Act;
       ``(2) administer and coordinate programs, as determined by 
     the Secretary, to increase organ donation rates;
       ``(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, 
     procurements, and transplants; and
       ``(4) provide information--
       ``(A) to patients, their families, and their physicians 
     about transplantation; and
       ``(B) to patients and their families about 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.''.

     SEC. 7. ADDITIONAL AMENDMENTS.

       Part H of title III of the Public Health Service Act (42 
     U.S.C. 273 et seq.) is amended--
       (1) in section 374 (42 U.S.C. 274b)--
       (A) in subsection (b)(1), by striking ``and may not exceed 
     $100,000'' and inserting ``and other organizations for the 
     purpose of increasing the supply of transplantable organs''; 
     and
       (B) in subsection (b)(2), by striking the second sentence;
       (2) in section 376 (42 U.S.C. 274d), by striking 
     ``Committee on Energy and Commerce'' and inserting 
     ``Committee on Commerce''; and
       (3) by striking section 377 (42 U.S.C. 274f).

     SEC. 8. PAYMENT OF TRAVEL AND SUBSISTENCE EXPENSES INCURRED 
                   TOWARD LIVING ORGAN DONATION.

       Part H of title III of the Public Health Service Act (42 
     U.S.C. 273 et seq.) is amended by inserting after section 376 
     the following section:

     ``SEC. 376A. TRAVEL AND SUBSISTENCE PAYMENTS FOR LIVING ORGAN 
                   DONATION.

       ``(a) In General.--The Secretary may make awards of grants 
     or contracts to

[[Page S2540]]

     States, transplant centers, qualified organ procurement 
     organizations under section 371, or other public or private 
     entities for the purpose of--
       ``(1) providing for the payment of travel and subsistence 
     expenses incurred by individuals toward making living 
     donations of their organs (referred to in this section as 
     `donating individuals'); and
       ``(2) in addition, providing for the payment of such 
     incidental nonmedical expenses that are so incurred as the 
     Secretary determines by regulation to be appropriate.
       ``(b) Eligibility.--
       ``(1) In general.--Payments under subsection (a) may be 
     made for the qualifying expenses of a donating individual 
     only if--
       ``(A) the State in which the donating individual resides is 
     a different State than the State in which the intended 
     recipient of the organ resides; and
       ``(B) the annual income of the intended recipient of the 
     organ does not exceed $35,000 (as adjusted for fiscal year 
     2002 and subsequent fiscal years to offset the effects of 
     inflation occurring after the beginning fiscal year 2001).
       ``(2) Certain circumstances.--Subject to paragraph (1), the 
     Secretary may in carrying out subsection (a) provide as 
     follows:
       ``(A) The Secretary may consider the term `donating 
     individuals' as including individuals who in good faith incur 
     qualifying expenses toward the intended donation of an organ 
     but with respect to whom, for such reason as the Secretary 
     determines to be appropriate, no donation of the organ 
     occurs.
       (B) The Secretary may consider the term `qualifying 
     expenses' as including the expenses of having one or more 
     family members of donating individuals accompany the donating 
     individuals for purposes of subsection (a) (subject to making 
     payment for only such types of expenses as are paid for 
     donating individuals).
       ``(c) Limitation on Amount of Payment.--
       ``(1) In general.--With respect to the geographic area to 
     which a donating individual travels for purposes of section 
     (a), if such area is other than the covered vicinity for the 
     intended recipient of the organ, the amount of qualifying 
     expenses for which payments under such subsection are made 
     may not exceed the amount of such expenses for which payment 
     would have been made if such area had been the covered 
     vicinity for the intended recipient, taking into account the 
     costs of travel and regional differences in the cost of 
     living.
       ``(2) Covered vicinity.--For purposes of this section, the 
     term `covered vicinity' with respect to an intended recipient 
     of an organ from a donating individual, means the vicinity of 
     the nearest transplant center to the residence of the 
     intended recipient that regularly performs transplants of 
     that type of organ.
       ``(d) Relationship to Payments Under Other Programs.--An 
     award may be made under subsection (a) only if the applicant 
     agrees that the award will not be expended to pay the 
     qualifying expenses of a donating individual to the extent 
     that payment has been made, or can reasonably be expected to 
     be made, with respect to such expenses--
       ``(1) under any State compensation program, under an 
     insurance policy, or under any Federal or State health 
     benefits program; or
       ``(2) by an entity that provides health services on a 
     prepaid basis.
       ``(e) Definitions.--In this section:
       ``(1) Covered vicinity.--The term `covered vicinity' has 
     the meaning given such term in subsection (c)(2).
       ``(2) Donating individual.--The term `donating individual' 
     has the meaning indicated for such term in subsection (a)(1), 
     subject to subsection (b)(2)(A).
       ``(3) Qualifying expenses.--The term `qualifying expenses' 
     means the expenses authorized for purposes of subsection (a), 
     subject to subsection (b)(2)(B).
       ``(f) Authorization of Appropriations.--For the purpose of 
     carrying out this section, there is authorized to be 
     appropriated $5,000,000 for each of fiscal years 2000 through 
     2005.''.

     SEC. 9. PROGRAMS AND DEMONSTRATION PROJECTS TO INCREASE ORGAN 
                   DONATION.

       Part H of title III of the Public Health Service Act (42 
     U.S.C. 273 et seq.) is amended by inserting after section 377 
     the following:

     ``SEC. 377A. INITIATIVES TO INCREASE ORGAN DONATION.

       ``(a) Public Awareness.--The Secretary shall (directly or 
     through grants or contracts) carry out a program to educate 
     the public with respect to organ donation.
       ``(b) Studies and Demonstrations.--The Secretary may make 
     grants to public and nonprofit entities for the purpose of 
     carrying out studies and demonstration projects with respect 
     to increasing rates of organ donation. The Secretary shall--
       ``(1) give priority to those studies and demonstration 
     projects that are founded upon a best practices approach to 
     increasing organ donation consent rates;
       ``(2) give priority to those geographic areas with lower 
     organ donation consent rates, especially among minorities;
       ``(3) provide assistance to qualified organ procurement 
     organizations described under section 371 to implement 
     programs and projects, that as determined by Secretary 
     through studies and demonstration projects, have proven to be 
     effective in increasing organ donation rates; and
       ``(4) provide assistance to the study and consideration of 
     presumed consent as an opportunity to increase organ donation 
     rates.
       ``(c) Grants to States.--The Secretary may make grants to 
     states for the purpose of carrying out public education and 
     outreach programs designed to increase the number of organ 
     donors within the State. To be eligible, each State shall--
       ``(1) submit an application to the Secretary, in such form 
     as prescribed by the Secretary; and
       ``(2) establish yearly benchmarks for improvement in organ 
     donation rates in the State.
       ``(d) Congressional Medal.--
       ``(1) Design.--The Secretary shall design a bronze medal 
     with suitable emblems, devices, and inscriptions, to be 
     determined by the Secretary, to commemorate organ donors and 
     their families.
       ``(2) Eligibility.--Any organ donor, or the family of any 
     organ donor, shall be eligible for a medal under this 
     subsection.
       ``(3) Requirements.--The Secretary shall direct the Organ 
     Procurement and Transplantation Network, established under 
     section 372, to--
       ``(A) establish an application procedure requiring the 
     relevant organ procurement organizations, described in 
     section 371, through which an individual or their family made 
     an organ donation, to submit documentation supporting the 
     eligibility of that individual or their family to receive a 
     medal; and
       ``(B) determine through the documentation provided, and, if 
     necessary, independent investigation, whether the individual 
     or family is eligible to receive a medal.
       ``(4) Delivery.--The Secretary shall make suitable 
     arrangements as necessary with the Secretary of the Treasury 
     to strike and deliver the medals described in paragraph (3).
       ``(5) Presentation.--The Secretary shall provide for the 
     presentation to the relevant organ procurement organizations 
     all medals struck pursuant to this section to individuals or 
     families that, in accordance with paragraph (3), the Organ 
     Procurement and Transplantation Network has determined 
     eligible to receive medals.
       ``(6) Limitation.--
       ``(A) in general.--Except as provided in subparagraph (B), 
     only 1 medal may be presented to a family under paragraph 
     (5). Such medal shall be presented to the donating family 
     member, or in the case of a deceased donor, the family member 
     who signed the consent form authorizing, or who otherwise 
     authorized, the donation of the organ involved.
       ``(B) Additional medals.--In the case of a family in which 
     more than 1 member is an organ donor, an additional medal may 
     be presented to each such organ donor or their family.
       ``(7) Duplicates.--The Secretary or the Organ Procurement 
     and Transplantation Network may provide duplicates of a 
     medal--
       ``(A) to any recipient of a medal under paragraph (4) under 
     such regulation as the Secretary may issue; and
       ``(B) the cost of which shall be sufficient to cover the 
     costs of such duplicates.
       ``(8) National medals.--The medals struck pursuant to this 
     subsection are national medals for purposes of section 5111 
     of title 31, United States Code.
       ``(9) Applicability of provisions.--No provision of law 
     governing procurement or public contracts shall be applicable 
     to the procurement of goods or services necessary for 
     carrying out the provisions of this subsection.
       ``(10) Funding.--
       ``(A) Agreements.--The Secretary of the Treasury may enter 
     into an agreement with the Organ Procurement and 
     Transplantation Network to collect funds to offset 
     expenditures relating to the issuance of medals authorized 
     under this subsection.
       ``(B) Payment and limitation.--
       ``(i) Payment.--Except as provided in clause (ii), all 
     funds received by the Organ Procurement and Transplantation 
     Network under this paragraph shall be promptly paid to the 
     Secretary of the Treasury.
       ``(ii) Limitation.--Not more than 5 percent of any funds 
     received under this paragraph may be used to pay 
     administrative costs incurred by the Organ Procurement and 
     Transplantation Network as a result of an agreement 
     established under this subsection.
       ``(C) Deposits and expenditures.--Notwithstanding any other 
     provision of law--
       ``(i) all amounts received by the Secretary of the Treasury 
     under paragraph (10)(A)(i) shall be deposited in the 
     Numismatic Public Enterprise Fund, as described in section 
     5134 of title 31, United States Code; and
       ``(ii) the Secretary of the Treasury shall charge such fund 
     with all expenditures relating to the issuance of medals 
     authorized under this subsection.
       ``(D) Start-up costs.--A one-time amount of not to exceed 
     $55,000 shall be provided by the Secretary to the Organ 
     Procurement and Transplantation Network to cover initial 
     start-up costs to be paid back in full within 3 years of the 
     date of enactment of this section from funds received under 
     this subsection.
       ``(11) Definition.--For the purposes of this section, the 
     term `organ' means the human kidney, liver, heart, lung, 
     pancreas, and any other human organ (other than corneas and 
     eyes) specified by regulation by the Secretary.
       ``(12) Effective date.--This subsection shall be effective 
     for the 5-year period beginning on the date of the enactment 
     of this section.

[[Page S2541]]

       ``(e) Annual Report to Congress.--The Secretary shall 
     submit to the Congress an annual report on the activities 
     carried out under this section, including provisions 
     describing the extent to which the activities have affected 
     the rate of organ donation.
       ``(f) Authorization of Appropriations.--
       ``(1) In general.--For the purpose of carrying out this 
     section, there are authorized to be appropriated $10,000,000 
     for fiscal year 2000, and such sums as may be necessary for 
     each of the fiscal years 2001 through 2005. Such 
     authorization of appropriations is in addition to any other 
     authorizations of appropriations that are available for such 
     purpose.
       ``(2) Public Awareness.--Of the amounts appropriated under 
     paragraph (1) for a fiscal year, the Secretary may not 
     obligate more than $2,000,000 for carrying out subsection 
     (a).''.

     SEC. 10. AUTHORIZATION OF APPROPRIATIONS.

       Section 378 of the Public Health Service Act (42 U.S.C. 
     274g) is amended to read as follows:

     ``SEC. 378. AUTHORIZATION OF APPROPRIATIONS FOR ORGAN 
                   PROCUREMENT AND TRANSPLANTATION NETWORK.

       ``For the purpose of providing for the Organ Procurement 
     and Transplantation Network under section 372, and for the 
     Scientific Registry under section 373, there are authorized 
     to be appropriated $4,000,000 for fiscal year 2000, and such 
     sums as may be necessary for each of fiscal years 2001 
     through 2005.''.

     SEC. 11. PREEMPTION.

       Part H of title III of the Public Health Service Act (42 
     U.S.C. 273 et seq.) is amended by inserting after section 378 
     the following:

     ``SEC. 378A. PREEMPTION.

       ``No State or political subdivision of a State shall 
     establish or continue in effect any law, rule, regulation, or 
     other requirement that would restrict in any way the ability 
     of any transplant hospital, organ procurement organization, 
     or other entity to comply with the organ allocation policies 
     of the Network under this part.''.

     SEC. 12. EFFECTIVE DATE.

       The amendments made by this Act shall take effect on 
     October 1, 2000, or upon the date of enactment of this Act, 
     whichever occurs later.
                                 ______