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  5. U.S. Department of Health and Human Services Recommendations 36-41

U.S. Department of Health and Human Services Recommendations 36-41

The Committee (ACOT) met on November 4-5, 2004, in Rockville, MD, and unanimously agreed on the following 6 recommendations:

Recommendation 36: The Advisory Committee on Organ Transplantation (ACOT) recommends that the Secretary of Health and Human Services (HHS) seek authority to identify and exclude certain practices from the definition of "valuable consideration" in section 301(a) of the National Organ Transplant Act, as amended.

The Secretary's authority should be limited to legitimate and beneficial practices that are intended to increase the supply of human organs, without creating a commercial market for the purchase or sale of human organs or posing a risk of coercion of a potential donor or donor family. In addition, the Secretary should be required to obtain an appropriate independent ethical evaluation before excluding any practice from the prohibition on valuable consideration.

ACOT has concluded that a process to limit the scope of "valuable consideration" would encourage the development of ethical practices to increase the supply of human organs and provide certainty to the transplant community about the scope of permissible activities. Regulatory authority is both more flexible and more responsive to innovation than an expanded statutory list of practices that are not included in the term "valuable consideration." The notice and comment period will provide an opportunity for public and professional input into any proposed regulation.

ACOT, therefore, recommends that Section 301 of the National Organ Transplant Act be amended in its entirety to read as follows:

  • (a) Prohibition

    It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation if the transfer affects interstate commerce.
  • (b) Penalties

    Any person who violates subsection (a) of this section shall be fined not more than $50,000 or imprisoned not more than five years, or both.
  • (c) Definitions

    For purposes of subsection (a) of this section:

    The term "human organ" means the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin or any subpart thereof and any other human organ (or any subpart thereof, including that derived from a fetus) specified by the Secretary of Health and Human Services by regulation.

    The term "valuable consideration" does not include the reasonable payments associated with the removal, transportation, implantation, processing, preservation, quality control, and storage of a human organ, the expenses of travel, housing, and lost wages incurred by the donor of a human organ in connection with the donation of the organ, or such other practices that the Secretary of Health and Human Services shall designate by regulation pursuant to subsection (d) of this section.

    The term "interstate commerce" has the meaning prescribed for it by section 321(b) of Title 21.
  • (d) The Secretary of Health and Human Services shall propose and promulgate regulations to ensure that interpretations of subsection (c)(2) do not impede legitimate and beneficial practices that are intended to increase the supply of human organs available for transplantation, provided, however, that any practice that poses a risk of coercion in connection with the donation of a human organ or of the creation of a commercial market for the purchase or sale of human organs is not a legitimate or beneficial practice within the meaning of this subsection (d). In considering legitimate and beneficial practices that will be excluded from the prohibition on valuable consideration set forth in subsection (c)(2), the Secretary shall seek an ethical evaluation from an appropriate entity, including without limitation the Institute of Medicine and the President's Council on Bioethics, or such similar or successor entity."

Recommendation 37: The ACOT recommends that the Secretary of HHS encourage States to undertake demonstration projects to test the feasibility of adopting a model of presumed consent to organ donation.

The current system for the donation of human organs from deceased donors is based on a default assumption that individuals prefer not to donate their organs after their death. A policy of presumed consent would include as a default assumption that individuals do prefer to donate their organs for transplantation at death. Because of the life-saving potential of transplantation, a presumed consent model would be a moral improvement over the current system, provided individual autonomy is appropriately protected through a system of declining to donate.

The ACOT, therefore, recommends that the Secretary authorize, encourage, and support State demonstration projects to design and implement "presumed consent" models for making anatomical gifts. The precise design of such models should be left to the states, provided that any State demonstration project authorized by the Secretary shall include provisions to ensure adequate notification and education of the citizens of the State and a method designed to permit any person not wishing to authorize an anatomical gift at death to register a decision to refuse to authorize an anatomical gift.

ACOT believes that until presumed consent models are tested, HHS cannot make an informed decision on whether presumed consent is a viable alternative for increasing donation rates. Such project(s) will be reviewed by HHS to determine if these program(s) increase the supply of organs as a result of presumed consent.

Recommendation 38: The ACOT recommends that the Secretary of HHS continue to incorporate the constructs and concepts of Burden of Disease (BOD) into ongoing analytical efforts. These constructs must include both patient and objective standpoints.

ACOT Recommendation 31 urged the OPTN to continue its efforts at developing a national standardized transplant Quality of Life (QOL) tool that could be made available to all transplant centers for assessing transplant end points in addition to mortality.

The Data Working Group (DWG) was created to coordinate between the Scientific Registry of Transplant Recipients (SRTR) and the OPTN to make sure that the right data are collected in appropriate and efficient ways. The DWG is advisory to OPTN and the scientific committee of SRTR.

Analysis of transplant outcomes has so far focused on time to death and time to graft loss. Although these are clearly important outcomes, with improving patient and graft survival they are no longer the only relevant outcomes to consider. Because it is not sufficient to consider only graft and overall survival, ACOT charged the DWG with looking into quality of life issues.

ACOT anticipates continuing its involvement with QOL issues for transplant recipients and to capture the importance of burden of disease. ACOT recommends that direction be given to the entities pursuing burden of disease in a QOL model, including QOL endpoints plus other elements (e.g., hospitalizations, mortality, patient standpoints).

Recommendation 39: The ACOT recommends that the Secretary of HHS encourage the OPTN to evaluate allocation policies to expand the utilization of hearts.

Heart utilization rates vary from transplant center to transplant center and from Designated Service Area (DSA) to DSA. It is not known why this occurs. Utilization rates vary according to OPO performance, surgeon preferences, etc., and it is a complex issue.

The OPTN Thoracic Committee published a proposed policy for comment to widen the sharing area for Status 1 patients. The intent is to increase utilization. Presently, 100 or more hearts per year are going unused. By widening the sharing area, immediate utilization by Status 1 patients would be increased. Twenty-two percent of DSAs do not do match runs for placing hearts. It is possible that some diagnostic tests performed on the potential donor may have shown that the heart is compromised in some way. Changing the allocation strategy as modeled by SRTR would allow 112 more transplants per year and 20 more deaths. There is a net benefit.

ACOT views this change in the sharing area as a positive step in utilizing more donors. However, the proposed policy has not been seen by some in a positive light. The challenge for OPTN will be to look at this proposed change and decide whether to implement the policy. Following public comment and reconsideration by the Thoracic Committee the proposal will be offered for consideration to the OPTN/UNOS Board of Directors.

Recommendation 40: The ACOT recommends that the Secretary of HHS authorize HHS oversight for whole-body donation.

The issue of whole-body donation was brought to ACOT's attention through media reports of events involving desecration—denigrating human bodies to the level of commodities. ACOT's concern is that when an untoward event is covered by the media, it casts a shadow on what we do in transplantation. There is a public safety issue, as well. The fact is that there are many more tissue donors than organ donors every year. Tens of thousands of lives are benefited by tissue donation. Whole body donation is also significant. Any single event in any of these arenas affects the others. The public does not distinguish among these different areas.

Currently, no single regulatory body has oversight over this area. FDA does not have control over human tissue for study. The FDA becomes involved only if there was crossover and some tissue for study was transplanted or used for treatment. Although some states have laws about transporting bodies over state lines, regulations governing disposition of bodies vary among the states. ACOT's recommendation is for providing HHS oversight and greater accountability.

Recommendation 41: The ACOT recommends that the Secretary of HHS direct the OPTN to develop allocation policy pertaining to nondirected, living-donor organs.

ACOT believes that individuals offering nondirected, living organ donation should not be subjected to any sort of coercion. Payment for organ donation is illegal in the United States. However, reimbursement for medical and related expenses, including housing, travel, and lost wages is acceptable and encouraged. In fact, Congress recently passed legislation that provides the authority for HHS to award a grant for supporting reimbursement of travel and expenses toward living organ donation.

ACOT recommendation is to have the allocation of the nondirected, living donor organ under the stewardship of the transplant community in the same manner as deceased donor organs. The appropriate allocation unit for a nondirected, living donor organ should be a small geographic unit, so as to minimize cold ischemia time and maximize the benefit of using a living donor. The unit might legitimately be the transplant center or the city in which the transplant center is located. The unit of allocation should be determined prospectively by the OPTN.

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