section is effective 9 months after enactment. Prior to this date, section 371(b)(3)(E) of the PHSA will remain in effect.

VIII. COMMITTEE VIEWS

ORGAN TRANSPLANT PROGRAM

The nationwide organ procurement and allocation system is faced with several problems. There is currently a shortage of transplantable organs, the equity of organ allocation procedures is questionable, and the Department of Health and Human Services (DHHS) has not yet issued regulations on organ donation or allocation.

The problems and concerns noted above were discussed in the General Accounting Office's (GAO) report Organ Transplants: Increased Effort Needed to Boost Supply and Ensure Equitable Distribution of Organs, (GAO/HRD-93-56, April 1993). This report was mandated by the Transplant Amendments Act of 1990 (P.L. 101-616).

There is an increasing disparity between the number of available organs and the number of patients waiting for transplants. More than 30,000 Americans are currently on organ waiting lists. 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 as successful. According to figures from the Association of Organ Procurement Organizations (AOPO), the overall rate of donation has been flat and has even decreased in certain OPOs in 1992 compared to previous years. Yet organ demand has increased by 50 percent since 1988. This legislation addresses the need to enhance organ donation, and the need to make organ procurement and allocation more equitable so that waiting times for organs do not vary drastically in different parts of the country as they do now. The original intent of the National Organ Transplant Act (NOTA) was to assure patients that no matter who they were or where they lived, they would have a fair chance of receiving a necessary organ transplant. The Committee believes that the organ procurement and allocation system can be improved by focusing on public education, addressing problems in the current system, and increasing the role transplant recipients, donor families, and community leaders play in the process. In addition, serious consideration should be given to changing the current system of allocating organs to ensure that patients have an equivalent probability of receiving an organ as do other patients with similar characteristics within the same region or in other regions.

Between 12,000 and 15,000 people each year become potential organ donors, yet only 4,500 individuals donated their organs in 1992 (Survey of OPOS, AOPO, 1993). There is clearly potential for increasing the number of organ donors. To improve organ procurement performance among OPOS and hospitals, the Committee has given the Secretary of HHS the authority to make grants to fund public education projects that address the need for organ donation, for training health care providers to request organ donations, and for providing technical assistance to OPOs and other health care entities. In addition to OPOs and non-profit private organizations, the Committee bill would make DHHS grants available to other

public entities. For example, grants could be given to projects encouraging state Divisions of Motor Vehicles to share information with OPOS about people who had signed organ donor cards, provided there was no infringement on donor confidentiality. Grants to foster better cooperation between OPOS and medical examiners is another area where grants to public entities may increase organ donation rates.

The Committee believes that education and technical assistance have great potential for increasing the level of organ donation. The Partnership for Organ Donation found that survey respondents of all ages, education, and ethnic backgrounds were more likely to donate the organs of a family member if they had discussed the issue with that person. Of the total respondents, 93 percent were very likely to donate a family member's organs if it had been discussed. If there had been no discussion, only 47 percent of respondents would have donated a family member's organs (The American Public's Attitudes Toward Organ Donation and Transplantation. Houston: The Gallup Poll Organization, 1990). However, donation does not take place, even with a signed donor card, if there is not consent from the next-of-kin.

Better public education can also help address organ donation among minority and other populations whose donation rates are lower than that of the general population, and who face longer waiting times and a more severe shortage of organs. Since there is a higher degree of compatible matching between members of the same ethnic group, it is critical that minority populations donate organs to insure the availability of organ transplants for minority populations.

This legislation would support projects that would increase public awareness about these organ donation matters. As indicated by this report, increase public awareness and communication among families and communities would enhance organ donation. Considering the widespread public support for organ donation, and the lack of education regarding this matter, the Committee feels improvements can and should be made in the area.

The United States should adopt a consistent and fair nationwide system of organ allocation and move away from the current fragmented and inconsistent system that has evolved despite the National Organ Transplant Act (NOTA). One obstacle to achieving this consistency is the current variation in organ donation and allocation policies among OPOs. A further problem is that OPO service areas vary substantially in size, population, and donation rates. Therefore, even if all OPOs 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 other OPÓS.

The April 1993 GAO report states that OPO allocation procedures vary drastically, and that different OPO practices may account for differences in procurement rates. The same report found that 25 of the 68 OPOs do not follow OPTN allocation standards. For example, certain OPOs use individual transplant center waiting lists rather than an OPO-wide list. Both these practices can result in less critical patients receiving organs before more needy patients. Moreover, patients are encouraged to list themselves with

multiple transplant centers, introducing another level of unfairness compared to those patients who are carried only on a single list.

The Committee is concerned with these policies and variations because they may inhibit equitable organ procurement and allocation. The Committee urges the DHHS to issue regulations defining allocation policies nationwide as soon as possible. The lack of Federal regulatory oversight and the fact that UNOS policies are not binding are creating havoc in organ allocation policies nationwide. The Committee has strong reservations about the idea of default by which UNOS policies would automatically become Federal policy if the Secretary fails to issue final rules before a specific deadline. While the Committee is concerned that the Department has not adequately performed its oversight role essential to the proper functioning of the organ transplant program, we are not comfortable with statutorially delegating this authority to an independ

ent contractor.

The Committee believes that the OPTN should maintain 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. The Committee does not believe that a separate list for foreign nationals should be required at this time. Instead, the Committee bill directs the GAO to provide more information on the number of transplants provided to foreign nationals and nonresident aliens and the potential need for a separate list. The GAO report will provide useful data on whether this practice of transplanting foreigners occurs more frequently in certain OPOS or transplant centers, and on the rate of donation by foreign nationals or nonresident aliens in this country. The Committee has learned that the New England Organ Bank has a reciprocal agreement with Bermuda and has also directed GAO to report on the extent of reciprocal agreements between OPOs and foreign countries. In order to achieve some degree of consistency among and across OPOS concerning organ allocation, the Committee believes that OPOS should be required, with some notable exceptions, to have single patient lists encompassing their entire service area. The Committee bill provides for two types of exceptions: a region consisting of a least an entire State or an approved alternative local unit. This requirement would be made effective nine months after enactment to allow for a smother transition period. The Committee feels that alternative local units should be approved at the discretion of the OPTN, and based upon established criteria. The Secretary of DHHS would retain final authority to amend the decisions of the OPTN.

The Committee acknowledges the need for exceptions to the single OPO wide list because OPOS vary specifically in size, donation rates, population, and number of transplant centers. Some exceptions to a single OPO wide list are necessary to promote equitable organ procurement and allocation in the short run. The bill recognizes exceptions to a single OPO-wide list such as areas comprised of two or more contiguous OPOS, and subdivisions of OPOS that operate as distinct procurement and distribution units and address special geographic, rural, or minority population concerns. The Committee believes these exceptions to a single list are necessary

as an interim measure until a more equitable allocation system is established.

The GAO report required by this legislation will help the Committee identify future changes needed to assure equity in organ allocation. Sufficient data on the impact of different allocation processes is not widely available and no consensus has been reached on how to transition to a more equitable allocation of organs. Currently, waiting times for all types of organ transplants vary from a few months to a few years, both within and across organ procurement organization service areas. The GAO will study the composition of OPO and OPTN boards, donation rates, the current allocation system, and how to establish an allocation system so that patients in one region of the country have an equivalent probability of receiving an organ as do patients with similar characteristics in that same region or in another region of the country. The Committee bill directs the GAO to take into account a number of issues including: information from experts in the field of organ transplantation, the medical appropriateness of patients waiting for transplant, the geographic proximity of patients with comparable priority for receiving an organ, and the impact on organ donation and procurement rates. The study is to be completed within 2 years of enactment.

The Committee is concerned about reports that hospitals are shopping around for OPOS and is concerned about the increasing number of disputes between OPOS and hospitals within their service areas that have elected to enter into agreements with other OPOS. The Committee considered requiring hospitals to work with their designated OPO but was apprehensive about disrupting current arrangements between OPOS and hospitals and forcing new relationships that could damage an already fragile procurement process and lead to a decline in organ donations. The Committee was also hesitant to require hospitals to work with specific OPOS because the Department of HHS has not yet issued clear guidelines for evaluating OPO performance. To address this concern, the Committee bill will require the Office of Technology Assessment to recommend standards by which to judge OPO performance, and criteria by which to determine inadequate OPO service. This bill requires the OTA study to be completed within 2 years of enactment. Under section 371 of the Public Health Service Act (PHSA), OPOS are currently required to annually evaluate their effectiveness in procuring organs. But the Committee has found that this requirement is often not enforced. The Committee therefore clarifies in this bill that OPOS are required to collect and report specific procurement data to the OPTN. This data would be used to determine areas and facilities needing special assistance in improving rates of organ procurement. It would also help OPOS and the OPTN develop a "best practice guide" to what works and how to best use limited resources to increase organ procurement.

Ultimately, the organ transplant and allocation system can be improved by allowing those most directly affected by this legislation, transplant recipients, to have a role in the process. The Committee believes an increased role for transplant recipients candidates, and donor families in all parts of the transplantation network will help assess the very difficult moral and ethical consider

ations of allocating scarce organs. The Committee also recognizes that it may be appropriate to include family members of transplant candidates, for example, in pediatric transplant cases. Increasing the representation of these groups on the OPTN and OPO boards is necessary to insure their views are heard and considered.

Inclusion of members from the general public and community is also important so they may aid in increasing public awareness and education about the need for donation. The Committee bill requires that the OPTN board be composed of at least 40 percent of general public representatives including transplant candidates or recipients and donor families. The Committee believes that the OPTN should solicit nominations from a variety of patient transplant and community groups to assure that the most qualified and effective persons are considered for the OPTN board.

There is little consensus in the transplant community on the ideal combination of represented interests-patients, minorities, community leaders, transplant centers, and medical expertise on the OPO boards. The Committee hesitates to specify a set percentage of general public or medical specialists for the OPO boards due to the vast differences in OPO structures and service areas and the lack of data on current OPO board compositions. However, the Committee does recommend that OPO boards be composed of a "reasonable balance" of members from the general public, donor families, and transplant recipients or candidates. The bill also requires the GAO to study OPO board composition, and the effect of this legislation on the composition and functioning of such boards. This bill changes the board of directors provisions for OPOs in one other way. Only hospital-based OPOs established previously may meet the current OPO board requirements through an advisory board. The Committee has learned that current law permits loopholes for independent OPSs to circumvent the distributional requirements for their governing boards in the statute and wants to eliminate this practice.

The Committee makes permanent the patient affairs committee which currently exists within UNOS and protects patients from arbitrary fee changes. The bill also requires the OPTN to submit patient registration fee changes to the Secretary of DHHS for prior review and approval. The Secretary is given a 90-day period in which to act before the fee change becomes effective.

Currently, 79 percent of UNOS revenue comes from patient registration fees. There is concern over fee increases and the way these fees are used by UNOS, the current contractor for Organ Procurement and Transplantation Network. Recently, the patient fee increased from $264 to $300. UNOS announced this change in a memo dated October 1, 1993. The increase was effective immediately, and was issued with no oversight and little justification. Under current requirements, UNOS was not required to submit this fee increase to the DHHS. The Committee believes that patient fees should be monitored by the Secretary because the OPTN has a monopoly. Patients have no other way to access the federally funded organ transplant program.