UNOS DonateLife

July 20, 1999

IOM Report Released

To: UNOS Members

From: William D. Payne, President

Date: July 20, 1999

Re: IOM Report: "Assessing Current Policies and the Potential Impact of the DHHS Final Rule"

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I am writing to update you on today's release of the Institute of Medicine's report examining the current OPTN policies and the potential impact of the HHS Final Rule released last year.

As you know, on April 2, 1998, HHS issued regulations that resulted in controversy and opposition from many in the transplant community. In response, late last year, Congress placed a one-year moratorium on the regulations, which expires on October 21, 1999, and asked the IOM to review current OPTN policy and the proposed effects of the Final Rule.

The IOM was originally scheduled to release the report to the public on Thursday, July 22. Unfortunately, a draft copy of the report's executive summary was given to a member of the press and a story appeared in this morning's USA Today that inaccurately interprets the report. Due to this unfortunate leak, the IOM was forced to abandon its original planned release and put the report out today. The executive summary of the report can be dowloaded as a PDF (http://books.nap.edu/html/organ_procure/organs.pdf). We have been told that more information on the report will be available on the National Academies' Web site. 

I have had the opportunity to initially review the executive summary and wanted to pass along some initial observations. When the final report is available and we have all had an opportunity to digest it, I will look forward to discussing it further with you.

Key Observations from the IOM Report:

• The Institute of Medicine has determined that America's organ-transplant system is basically fair.

We are pleased with IOM's assessment of the current system as "reasonably effective and equitable." We recognize that as long as there is an organ shortage, no system can meet every need. Nevertheless, the IOM concluded that allocation system for livers is reasonably equitable for the most urgent statuses and that UNOS administers the system even-handedly. The report does make recommendations regarding additional changes that I will ask our committees to address.

We are pleased with IOM's assessment of the current system as "reasonably effective and equitable." We recognize that as long as there is an organ shortage, no system can meet every need. Nevertheless, the IOM concluded that allocation system for livers is reasonably equitable for the most urgent statuses and that UNOS administers the system even-handedly. The report does make recommendations regarding additional changes that I will ask our committees to address.

• The Institute of Medicine has determined that the health of patients is not affected by geographic differences in the amount of time they wait for organ transplants and that these waiting-time differences are "not an appropriate measure of the fairness of the system."

The Institute of Medicine report could not be clearer. Its second recommendation is to "Discontinue use of waiting time as an allocation criterion for Statuses 2b and 3." It later adds: "Overall median waiting time, which has dominated the policy debate, is a poor measure of differences in access to transplantation." The report notes that the heavy emphasis placed on waiting times by the Department of Health and Human Services created the perception that the current system was unfair. The report repudiates this notion.

The Institute of Medicine report could not be clearer. Its second recommendation is to "Discontinue use of waiting time as an allocation criterion for Statuses 2b and 3." It later adds: "Overall median waiting time, which has dominated the policy debate, is a poor measure of differences in access to transplantation." The report notes that the heavy emphasis placed on waiting times by the Department of Health and Human Services created the perception that the current system was unfair. The report repudiates this notion.

• The Institute of Medicine has recommended a geographically based structure for organ distribution, which is remarkably similar to the regional system by which UNOS currently allocates livers to the most urgent patients.

At our June board meeting in Atlanta, UNOS approved a new policy that will increase the number of liver transplants for Status 1 patients. The policy puts Status 1 patients at the top of region-wide waiting lists in all 11 UNOS regions.

The IOM recommends creation of new Organ Allocation Areas consisting of 9 million population each through sharing arrangements through smaller OPOs. In that the UNOS regions have populations ranging from 10 million to 40 million, UNOS' recent change in liver allocation for the most urgent patients is consistent with this recommendation. It is encouraging that UNOS and IOM independently arrived at similar conclusions.

At our June board meeting in Atlanta, UNOS approved a new policy that will increase the number of liver transplants for Status 1 patients. The policy puts Status 1 patients at the top of region-wide waiting lists in all 11 UNOS regions.

The IOM recommends creation of new Organ Allocation Areas consisting of 9 million population each through sharing arrangements through smaller OPOs. In that the UNOS regions have populations ranging from 10 million to 40 million, UNOS' recent change in liver allocation for the most urgent patients is consistent with this recommendation. It is encouraging that UNOS and IOM independently arrived at similar conclusions.

• The Institute of Medicine found that UNOS policies do not discriminate because of race or any other factor and that all patients on the waiting list for an organ transplant are treated fairly.

The Institute of Medicine concluded that once transplant patients have been placed on waiting lists for organs, they are treated the same, regardless of racial or socioeconomic background. Unfortunately, the poor and minorities have limited access to all forms of basic health and medical care. While this should be a subject of concern, we are pleased that our policies do not contribute to this problem. The report states 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."

The Institute of Medicine concluded that once transplant patients have been placed on waiting lists for organs, they are treated the same, regardless of racial or socioeconomic background. Unfortunately, the poor and minorities have limited access to all forms of basic health and medical care. While this should be a subject of concern, we are pleased that our policies do not contribute to this problem. The report states 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."

• The Institute of Medicine found that the pending federal regulations will increase the overall cost of organ transplantation in America, supporting a conclusion reached last year by the consulting firm Price Waterhouse.

UNOS was concerned early on that the pending regulations would increase the cost of transplantation and that no estimates of that increase were available.

UNOS retained the firm Price Waterhouse, which concluded that the overall costs of organ transplantation would increase. We are please that the Institute of Medicine found this concern to be valid.

UNOS was concerned early on that the pending regulations would increase the cost of transplantation and that no estimates of that increase were available.

UNOS retained the firm Price Waterhouse, which concluded that the overall costs of organ transplantation would increase. We are please that the Institute of Medicine found this concern to be valid.

• UNOS believes that Congress must decide what role the federal government should play in overseeing the organ-transplant system.

The Institute of Medicine recommends that the federal government play a more active role in the organ transplant system, but does not define what that role should be. Congress made clear when it passed the National Organ Transplant Act 15 years ago that crucial medical decisions about transplantation should be made by the medical community. Only Congress can decide whether to change that standard and determine what changes might be appropriate.

The Institute of Medicine recommends that the federal government play a more active role in the organ transplant system, but does not define what that role should be. Congress made clear when it passed the National Organ Transplant Act 15 years ago that crucial medical decisions about transplantation should be made by the medical community. Only Congress can decide whether to change that standard and determine what changes might be appropriate.

• UNOS recently announced that it will publish even more data for patients about the performance of individual transplant centers and will make that information available to everyone in a matter of weeks.

The Institute of Medicine's report acknowledges that "UNOS currently collects, analyzes, and disseminates more data than are available for most other medical procedures" but that many people feel that these data should be more timely and more broadly available. In June, the UNOS Board of Directors voted to implement a state-of-the-art transplant data system using Internet technology. We will publish data about each American transplant center, including patient survival rates at one year after transplantation, and will update that data regularly so that the information published for the public and patients will be as timely as it can be.

The Institute of Medicine's report acknowledges that "UNOS currently collects, analyzes, and disseminates more data than are available for most other medical procedures" but that many people feel that these data should be more timely and more broadly available. In June, the UNOS Board of Directors voted to implement a state-of-the-art transplant data system using Internet technology. We will publish data about each American transplant center, including patient survival rates at one year after transplantation, and will update that data regularly so that the information published for the public and patients will be as timely as it can be.

• UNOS continues to believe that the pending federal regulations would significantly disrupt organ transplantation in the United States with serious negative consequences on organ donation and on patients served by local transplant centers.

The Institute of Medicine questions whether the pending regulations would close transplant centers, but is unable to come to a firm evidence-based conclusion. The IOM notes that those who believe closings would occur present "a reasonably accurate characterization of the current situation for some of the low volume transplant centers." The IOM also notes that its own conclusion is arguable, saying that "these data and analyses are suggestive, rather than conclusive." The clear consensus in the transplant community has been that the pending regulations threaten the existence of small- and medium-sized centers. Barring overwhelming evidence to the contrary, which does not exist, the pending regulations pose far too much risk to go forward.

The Institute of Medicine questions whether the pending regulations would close transplant centers, but is unable to come to a firm evidence-based conclusion. The IOM notes that those who believe closings would occur present "a reasonably accurate characterization of the current situation for some of the low volume transplant centers." The IOM also notes that its own conclusion is arguable, saying that "these data and analyses are suggestive, rather than conclusive." The clear consensus in the transplant community has been that the pending regulations threaten the existence of small- and medium-sized centers. Barring overwhelming evidence to the contrary, which does not exist, the pending regulations pose far too much risk to go forward.

Conclusions: The Institute of Medicine has questioned the basic medical premises of the pending federal organ-transplant regulations. Therefore, the regulations should be withdrawn. The Department of Health and Human Services should go back to the drawing board with the transplant community and agree on new policies that will benefit all patients.

Although the Institute of Medicine's report endorses increased federal oversight, its scientific findings knock out the very foundation of the pending regulations - and we will respectfully ask the Department of Health and Human Services to withdraw them. We've made progress in our recent discussions with HHS, and we ask that they continue to work with us to build a national organ-transplant system that continues to be fair and equitable, and has the support of the medical and transplant community.

I hope you find this information useful. As new information becomes available or new developments occur, I will be in touch with you again.