IOM report supports regional organ allocationA panel of experts asked by Congress to judge the fairness of the nation’s organ transplant system says that those patients who are the most in need of a transplant are being treated fairly under the current system.The Institute of Medicine (IOM) panel, whose report was recently released, also contradicted the Department of Health and Human Services’ (HHS) rationale for a new rule on organ transplant policy that made equalizing waiting times between regions of the country the highest federal priority. The panel said, “...median waiting times, the issue that brought us to the table in the first place, is a relatively meaningless statistic that should not be used for comparing access or equity of the current system.” HHS has predicated its rulemaking on the need to reduce disparities in waiting times for patients living in different parts of the country. However, the expert panel found that for the sickest patients, those in categories 1, 2a and 2b, waiting times varied little from region to region. Patients in the last category, status 3, were responsible both for most accumulated waiting times and the most variance in waiting times from region to region, but were also the least sick. Prabhakar Baliga, M.D., co-director of the MUSC Transplant Center, hailed the panel’s work. “This panel has done an outstanding job in evaluating a very complicated medical issue and has concluded what we in the transplant community have felt all along: the transplant system does work and everyone involved strives to maintain the highest degree of fairness. What we should be focusing on now is how can we increase the number of organ donors so that ‘organ scarcity’ becomes an antiquated term. “It is my hope that policymakers in Washington will recognize the system is not broken and while there is always room for improvement, those improvements that have the most potential for helping patients should come from the transplant community,” Baliga added. The panel found that the likelihood of receiving a transplant is the same across the 62 OPOs, or organ procurement organizations, throughout the country for the sickest patients. Mortality rates were also the same across the country for the sickest patients. The panel did say that the current system, like any system, can be improved and suggested that broader sharing of organs among OPOs could both increase the number of status 1 patients (patients with less than a week to live) being transplanted and reduce death rates for other patients in the sickest categories. The experts also highlighted the importance of reducing the rate at which organs have to be re-transplanted into patients where an initial transplant fails. The panel said that, “strategies that minimize the number of organs lost to primary non-function are essential. ...For the most part, every organ lost to non-function further compounds the scarcity of an already highly limited resource. A 4.2 percent reduction in re-transplantation due to the avoidance of primary graft non-function by using livers with lower ischemic times (the time an organ is without oxygenated blood) would necessitate less re-transplantation and would mean that 170 additional patients could receive a liver transplant.” This finding conflicts with a basic effect of the HHS rule which would force organs to travel much farther, thus increasing ischemic times which would lead to higher re-transplantation rates. Concerning organ donation, the panel said “...a key factor that appears to result in higher donation rates is having requests made by the staff of the OPO working with the patient’s physician or nurse, rather than by hospital staff.” All observers agree that the real solution to the organ shortage is to increase organ donation rates. In April 1998, HHS announced a final rule on organ transplantation that created a firestorm of protest from the transplant community. HHS was criticized for overreaching its authority by dictating to the transplant community how organs should be allocated through the use of performance goals the transplant community said would increase the death rate for transplant patients. Organ allocation policy is now determined by the Organ Procurement and Transplantation Network made up of transplant surgeons, patients, OPO officials, and other professionals and volunteers involved in organ transplantation efforts. Because of widespread criticism of the HHS rule, Congress enacted a moratorium on the rulemaking and asked the Institute of Medicine, a division of the National Academy of Sciences, to review the issue. The panel’s recommendations will be sent to Congress. Congress could then do nothing, which would enable the HHS rule to go into effect in October when the moratorium expires, decide to extend the current moratorium or incorporate the finding into legislation that has been introduced to reauthorize the National Organ Transplant Act. In South Carolina, Attorney-General Charlie Condon has threatened to sue to stop enforcement of the federal rule if it should go into effect. Also Gov. Jim Hodges issued a statement supporting maintenance of the current allocation policy. (See text of statement). The Post and Courier in Charleston, following a news conference in Charleston last week took a strong editorial position against the new rules. (See text of editorial below) In 1998, more than 21,000 Americans received an organ transplant. Unfortunately,
more than 4,000 Americans die each year because no suitable organ is available.
There are currently 62,000 Americans waiting for an organ transplant and
that figure grows each year.
P & C opposes HHS regulations
Congress should act to maintain the current system of organ-donor allocation. And South Carolina —including the governor, the attorney general and MUSC—should proceed with plans to bolster its efforts toward that vital goal. The present format, both fair and practical, is in jeopardy of being
supplanted by a misguided set of revised, centralized regulations devised
last year by the U.S. Department of Health and Human Services —but wisely
delayed by Congress. Those “sickest first” HHS guidelines aim to eliminate
geographic
Billed on paper as more “equitable,” the HHS rule in practice would significantly lower the number of successful transplants while raising the rates of patient deaths and wasted organs. The local-preference option (organs now may be offered locally, then regionally, then finally nationally) currently in effect has been a decisive motivational tool in boosting organ donations. The present distribution format maximizes a sadly limited organ supply. More than 21,000 Americans received transplants last year, more than 4,000 die each year waiting for them and another 62,000 are still waiting. The new HHS format would, in a tragic, counterproductive twist, inevitably limit that supply. A congressionally appointed committee, in a report issued last week,
concluded that patients most in need of transplants nationwide are being
treated
Though it did call for broader sharing of organs among Organ Procurement Organizations, the panel dismissed the major premise behind the HHS changes, writing, “Median waiting times, the issue that brought us to the table in the first place, is a relatively meaningless statistic that should not be used for comparing access or equity of the current system.” That sounds like a telling blow to the HHS case. Congress already expressed
doubts about the HHS rule by tabling it last year. However, that temporary
South Carolina should move to the forefront of the widespread opposition to the HHS plan. Gov. Jim Hodges set the right tone Tuesday in Charleston with this statement: “South Carolina's organ allocation program is fair and must be maintained.” Attorney General Charlie Condon aptly dubbed the HHS rule the “one size fits none” approach and told our Lynne Langley that the state will sue to uphold a South Carolina law enacted last year to offer organs donated here first to residents and second within the region. Louisiana has filed a similar suit. And 32 transplant centers across the nation, including the Medical University of South Carolina, also are considering court action to block the HHS regulations. Those court actions must go forward. Congress, meanwhile, should recognize
the unintended-yet-inherent consequences of the HHS proposal and preserve
the current system that is saving so many lives.
Gov. Hodges supports current systemMUSC has received the following statement from South Carolina's Gov. Jim Hodges in support of the current organ allocation system.South Carolina's current organ allocation laws and policies do serve and are in the best interest of South Carolinians. Our organ allocation policy requires transplant organs to first be offered to the sickest patients within our local communities, then within our State, our region, and then finally made available nationally. This policy ensures that South Carolina families, physicians, and hospitals develop relationships within a local setting that provide the best care for all of our citizens requiring organ transplantation. Current efforts by the federal government to “nationalize” organ transplants will have a negative impact on South Carolina families. Fewer South Carolinians will have access to affordable transplantation services given that organs would be taken away from small and mid-size transplant centers and reallocated to a few large centers, thus resulting in closure for smaller, high quality centers. In addition, this national policy will make it more difficult for persons from all walks of life, including the poor and minorities, to have an equitable opportunity for transplants. South Carolina's organ allocation program is fair and must be maintained. Thus, I will closely follow this issue and am committed to working with the attorney general and other entities in this state to ensure that South Carolinians have access to transplants. |