STATEMENT OF THE AMERICAN SOCIETY OF TRANSPLANTATION AND TRANSPLANT RECIPIENTS INTERNATIONAL ORGANIZATION

On the Report of the Institute of Medicine
Organ Procurement and Transplantation

Introduction:

The report of the Committee on Organ Procurement and Transplantation Policy of the Institute of Medicine (IOM), entitled "Organ Procurement and Transplantation Assessing Current Policies and the Potential Impact of the DHHS Final Rule" was published on July 20, 1999. This report provides an objective review of the controversy surrounding allocation of cadaver livers for transplantation in the United States. The IOM had been charged by Congress to conduct a study of the current policies of the Organ Procurement and Transplant Network (OPTN) and the potential impact of the Final Rule published by the Secretary of the Department of Health and Human Services (DHHS) in the Federal Register on April 2, 1998(42 CFR Part 121).

The American Society of Transplantation (AST) is the largest professional organization of transplant physicians, surgeons and basic scientists in the United States. Transplant Recipients International Organization (TRIO) is the largest organization for transplant candidates, recipients, donors and their families. Together, we congratulate the committee and endorse the report of the Institute of Medicine. The committee has listened to all interested parties and has carefully weighed the evidence offered to them. They have made sage judgements that we hope will benefit all transplant patients and potential transplant recipients for years to come.

AST and TRIO have published position statements and testimony on these issues previously and we do not wish to repeat those positions. However, we will comment on the specific recommendations of the committee and on areas that seem to remain contentious. Our goal in doing so is to resolve disputes within the organ transplant community as quickly as possible so that we all can return to the important work of increasing organ donation, improving the outcome of transplantation for all recipients and restoring the confidence of patients, their families, and the public in the equity and integrity of the transplant community. It is time to move beyond divisiveness and negative rhetoric.

We call upon the Secretary to amend her rule based on the IOM report and following some of the specific guidelines we have laid out in this document. We also call upon the current OPTN contractor, UNOS, to work with DHHS and come to an agreement on these issues.

Organ specific allocation policies:

We have previously emphasized the important principle that different organ transplants require different allocation policies. For example, objective criteria of disease severity may be relevant to organs in which there is no suitable life support system, such as livers, lungs, or hearts. These types of criteria may have no relevance to other organ transplants, such as kidneys or pancreata, for which there are suitable support techniques. The IOM report is careful to make recommendations about liver transplantation. We urge the Secretary to review the Final Rule and indicate which proposed principles apply to limited numbers of transplant types and which apply to all transplants.

Standardized criteria:

The transplant community currently recognizes the need for standardized listing criteria, de-listing criteria and criteria for determining medical status. It is clearly within the purview of the OPTN to develop these criteria, to continually refine them based upon changes in clinical care resulting from advances in medical science, and to establish methods of local monitoring of compliance with these criteria. In this area, we would expect that DHHS be in a position of enforcing sanctions for non-compliance.

Reviews, Evaluation and Enforcement:

As noted below, and in agreement with the IOM report, we recognize the legitimate role of DHHS in reviewing the performance of the OPTN and its member organizations. We support Recommendation 8.2 (Establish Independent Scientific Review) and we pledge the assistance of our organizations in developing appropriate scientific review panels. We certainly agree that allocation and other policies, such as standardized listing criteria, must be enforced. However, as noted in section 121.10, the only enforcement outlined would involve relatively harsh penalties, including termination of a transplant hospital's participation in Medicare or Medicaid, or termination of a transplant hospital's reimbursement under Medicare or Medicaid. We believe that the regulation should provide an opportunity for due process and corrective action prior to the imposition of severe sanctions. The regulation should provide for the initial use of time-limited intermediate sanctions rather than appear to rely solely on complete withdrawal of center Medicare and Medicaid reimbursement.

Reducing Socio-Economic inequities:

We are encouraged by the IOM report's conclusion that "The most important predictors of equity in access to transplant services lie outside the transplantation system--that is, access to health insurance and high-quality health care services. Thus we are concerned that Section 121.4, subsection (3) of the final rule may seem to place a too-heavy burden on transplant hospitals and OPOs. Specifically, we propose that subsection (3) be changed to: "(i) Ensuring that patients in need of transplant are listed without regard to source of payment. (ii) Procedures for transplant hospitals to make reasonable efforts to obtain from other sources."

Secretarial Authority:

We note that three of the five specific recommendations included in the IOM addressed the area of oversight and review. The committee concluded that "oversight and review of the nation's organ procurement and transplantation system needs to be enhanced to improve the system's accountability to the public and to ensure that it operates effectively in the public interest." We strongly endorse and support Recommendation 8.1 (Exercise Federal Oversight) and we stand ready to assist DHHS in defining and updating performance standards for OPTN, OPOs and transplant centers. We simultaneously recognize and support the responsibility of the OPTN to make specific organ allocation policy based on sound medical principles and scientific data. In this setting, we are concerned that section 121.4 (b) and (d) could be interpreted as setting the stage for the Secretary of DHHS to make specific allocation policy. We thus suggest a reconsideration of those sections in order to clarify the respective roles. DHHS's oversight responsibility should be to ensure that the policies that guide the operation of the system are equitable and based on sound medical science. However, the Secretary must not dictate specific transplant practices or medical judgments. The OPTN's responsibility is to make specific policy concerning allocation and to modify that policy on the basis of developing medical practices.

OPTN Board Composition:

The final rule in Section 121.3 mandates an OPTN Board with a minimum of 30 members. Two seats are specifically allocated to transplant surgeons and two to transplant physicians. It provides that "transplant candidates, transplant recipients, organ donors and family members" shall comprise "at least 25 percent" of Board members; and that transplant surgeons and transplant physicians shall comprise "no more than 50 percent". We strongly believe that because of the technical and scientific as well as ethical and social problems continuously occurring in this field, transplant physicians and surgeons should comprise approximately 50 percent of the membership of the Board.

Allocation of Organs:

We completely endorse Recommendation 5.2 (Discontinue Use of Waiting Time as an Allocation Criterion for Patients in Status 2B and 3) of the IOM Report. Data analysis performed by the committee clearly indicates that waiting time is not a reasonable measure of equity of allocation for these patients nor is the disparity of overall median waiting time a reasonable measure of fairness of the current system. Thus, we recommend that certain sections of 121.8 be revised. As we have previously stated, neither time waiting nor medical urgency can be considered absolute measures of equity for allocation of all types of organs for transplantation. Thus, placing specific criteria within the final rule may not be efficient, particularly in a field with rapidly changing technology. Time waiting may be an appropriate measure for "tie breakers" in urgent situations, such as Status 1 and 2a liver transplants, as well as in non-urgent situations, such as for kidney transplantation. For these reasons, we would expect the final rule to contain general principles of equity and measures of it and we would suggest that the OPTN develop the specific policy that achieves equity. We specifically do not suggest that the current Final Rule be re-written entirely, but rather that it be refined to reflect the specific recommendations of the IOM Report.

Record Maintenance and Reporting Requirements:

We endorse Recommendation 8.3 ((Improve Data Collection and Dissemination). Both organizations agree with the Secretary that physicians, patients and the public should have access to accurate, understandable, and timely information regarding performance of the OPTN, OPOs and transplant centers. We agree with the provisions in Section 121.11 for updated data to be made available to the public "no less frequently than every six months.and shall be presented no more than six months later than the period to which they apply." We propose that data collection and dissemination protocols be set in place to achieve this goal of more frequent reporting within the next two years. It is extremely important that the Secretary assure that any release of data be done in a manner that preserves the confidentiality of individual patients and donors. Understanding that organ transplantation is performed infrequently even in the busiest centers, identification of the date and location of a procedure could simultaneously identify the donor and recipient. Thus, in some circumstances, appropriate coding of some information may be necessary.

Organ Allocation Units:

We endorse Recommendation 5.1 (Establish Organ Allocation Areas for Livers) and we suggest that the same principle of large population-based sharing be utilized for allocation of other organs. The report of the IOM committee found no evidence that supports the concerns that wider sharing would lead to decreased donation or closure of small programs. We suggest that the OPTN or an independent organization undertake similar studies for other organs to define the appropriate size of Organ Allocation Areas (OAAs) for each of them. We also understand that any OAAs will require some sort of administrative structure in order to operate and suggest that current UNOS Regions may be appropriate to serve these functions. In doing so, however, we specifically do not suggest any mandated changes in the size or composition of OPOs. We understand that the primary function of an OPO is the identification, recovery and distribution of organs for transplantation. If OPOs are required to deal with allocation, their collective energy and attention may be diverted from their primary responsibilities. Specifically, we suggested that the Final Rule recognize that organ recovery be disassociated from organ allocation.

Independent Scientific Review:

We endorse Recommendation 8.2 (Establish Independent Scientific Review). We agree with the committee that the system should be reviewed periodically by an independent body reporting to the Secretary and separate from the OPTN. The existence of the IOM report is evidence enough that an independent review can produce valuable and unexpected outcomes. We expect an appropriately composed body, which would include a reasonable number of individuals with expertise in transplantation, to bring resolution to difficult or contentious problems through careful objective review as the IOM has done with this report. We expect the Secretary and the OPTN to work together to develop solutions based upon recommendations of this body. We are prepared to suggest appropriate scientific experts to participate in these reviews.

DHHS and OPTN:

The report of the IOM committee clearly supports complementary roles of DHHS and the OPTN in the transplant system. Unfortunately, issues concerning allocation of livers for transplantation have led to substantial discord between the two organizations. While we understand the principles behind that discord and have commented on them previously, we firmly believe that the past year's debate and the report of the IOM committee have clarified those issues sufficiently and have provided us with the basis for moving forward. We are encouraged by the Secretary's announcement that DHHS is prepared to make alterations in the Final Rule in order to produce the best possible product and we are prepared to assist her in this effort. We call upon the OPTN to do the same. We must push forward to modernize the organ allocation system and to spend more of our time and effort on organ donation.

September 20, 1999

 

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