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Advisory Committee on Organ Transplantation

January 26, 2007

Convened by Conference Call

Present: Remy Aronoff, Gail B. Agrawal, Rhonda Boone, Suzanne L. Conrad, Samuel M. Holtzman, Mary S. Leffell, Lewis L. Low, Anita L. Principe, Kris Robinson, Peggy Rosenzweig, Velma P. Scantlebury, Mildred Z. Solomon, J. David Vega, Russell Wiesner, and Yiliang Zhu

Non-ACOT members participating in the call: Sue Dunne (Donor Alliance), Jennifer Martin (National Kidney Foundation), Mark McGinnis (HHS OGC), Carol O'Neill (Association of Organ Procurement Organizations), Bernice Reyes (Congressional Research Service), Susan Stuart (Center for Organ Recovery and Education), Jim Warren (Transplant News), Ed Weisgerber (K&L Gates), Carla Williams (New York Alliance for Donation), and Amanda Wong (The Health Policy Group).

Ms. Agrawal began the call by noting that the Advisory Committee on Organ Transplantation (ACOT) is holding the conference call to hear discussion from the ACOT members on the revision of the Uniform Anatomical Gift Act (UAGA) and to develop a recommendation from the ACOT to the Secretary concerning the revised UAGA. The revised UAGA is a model law drafted by the National Conference of Commissioners on Uniform State Laws in an effort to achieve uniformity among the anatomical gift laws of the States. At the November 2006 ACOT meeting, Mr. Carlyle (Connie) Ring, J.D., of the National Conference of Commissioners on Uniform State Laws, presented on the Act, so its contents will not be reviewed again during the call.

From her standpoint, one important reason to endorse the revised UAGA is to restore uniformity in the States — some States use the 1968 version while others use the 1986 revision, and there are now differences in the States. We are looking at this, in part, because we want uniformity among the States. With respect to ACOT, the revised UAGA reflects a few things from our earlier recommendations: Section 8 strengthens first-person consent (donor designation), for example, which is a recommendation that the ACOT made in 2003. The UAGA also calls for more cooperation between coroners and medical examiners (ME) with procurement entities, which is another recommendation ACOT made several years ago.

Ms. Agrawal noted that nothing in the revised UAGA is inconsistent with ACOT's work. ACOT's recommendations on the revised Act have been fully considered and incorporated by the Conference. There are other significant pieces of language, too. For example, this revision recognizes mature minors, which was not in the original Act; it expands the list of agents who are permitted to make gifts for another person; it expands the methods of making gifts, which is important because States have adopted and/or recognized registries, cards, and other methods that were not envisioned when the UAGA was first enacted; and it resolves the conflict between anatomical gifts and advanced directives, and favors gifts over the refusal of life support when the latter is needed for a donation to occur. Her review of the Act is positive. That was also the sense of the ACOT members after its November meeting.

Mr. Aronoff asked for comments from Mr. Ring. Mr. Ring responded that Ms. Agrawal had covered the issue well. The Conference project occurred in response to ACOT's recommendations. The enthusiastic support of ACOT and other stakeholders has been evidenced and will be extremely helpful in securing passage of the revised UAGA. As many as 40 States are expected to introduce it this year. Mr. Ring said he is happy to answer any questions.

Ms. Boone asked if the UAGA refers only to deceased donors, and Mr. Ring affirmed that it did. He noted that the Conference has been encouraged to draft a Uniform Act for living donors but that this task presents unique and special problems. The Conference has not decided if it will do this or not. Ms. Boone volunteered her services if the Conference does take this on. Mr. Ring asked Mrs. Boone to write him a letter asking the Conference to take on this project, and he will send it to the Scope and Program Committee.

Dr. Solomon added that, although the intent of the UAGA is about deceased donations, there are provisions that affect living donors. For example, one of the concerns with living donations has to do with prohibiting organ sales — hence the prohibition on valuable considerations. Mr. Ring concurred that provisions that relate to a statutory proscription arguably might be applicable to living donors. But really, it's more that the Federal prescription covers the living donors, through the National Organ Transplant Act (NOTA), which is independent of the Act.

Mr. Holtzman asked if the National Association of Medical Examiners (NAME) had any last-minute changes to the Act. Mr. Ring responded that they are in the process of a dialogue with NAME. Their concerns are limited and some States have already made accommodations to address the concerns. In Virginia, there has been a modest language change in Section 23 that is acceptable to the medical examiners. The medical examiners seem to be basically in accord with most of the Act and are mainly concerned about the necessity for instantaneous response from the medical examiners for tissue and eye donations. The changes are expected to be modest.

Mr. Holtzman asked if the version the ACOT is considering is the same as that presented at the last ACOT meeting, and Mr. Ring said that it was. The changes from NAME would be implemented State by State. Some States have introduced the Act and the medical examiners and coroners have had no objections. In other states, such as Virginia, there are problems with Subsection F. The existing protocols work well between procurement organizations and the medical examiner and coroner, and the request is to reference the existing protocols. It does not seem to have an impact on uniformity that would be contrary to ACOT's general recommendation for coordination among these entities. Mr. Holtzman asked that, if there are subsequent changes to the UAGA, they should be brought back before the ACOT. Mr. Ring agreed to keep the group updated on any changes.

Ms. Principe said that in New York the health care proxy situation is such that, if a legal next-of-kin has never been told by the family member that the family member is interested in removing life support, then the consent cannot be given by the legal next-of-kin. This is in contradiction to the process of approaching family members for donation after cardiac death (DCD), when the legal next-of-kin can give consent, even if the person hadn't mentioned it during his/her lifetime. Ms. Principe is unsure if the revised UAGA will clarify this or if the health care proxy will remain under the domain of the State and will have to be dealt with on that level in New York.

Ms. Agrawal said that the health care proxy is under the domain of the States. This Act does not change the basic nature of that; it takes care of a specific question with respect to how an existing health care proxy that has broad language interacts with an anatomical gift. Dr. Solomon said that she felt it would be a violation of standard ethical norms to say that a family in New York could be addressed for donation after cardiac death, under those circumstances. New York is an outlier, but it's required. There should not be an approach made to families for DCD until after a decision to forgo treatment has been made. She and Ms. Principe will talk further about this.

Ms. Agrawal asked if any ACOT members had comments to make, and there were none. She asked if non-ACOT participants in the call had any comments. Jim Warren from Transplant Newsasked how many of the 40 States expected to consider the revised UAGA would be doing so this year, and how many States have already begun to do so. Mr. Ring said that all 40 are expected in 2007. The UAGA has been introduced in 10 states; and in North Dakota and Virginia, it is already out of committee. Participants reported that Colorado is expected to introduce the UAGA by January 31 and likely to revise Sections 22 and 23. Texas will introduce it in the next few weeks. It is likely that parts of the current medical examiner law will be inserted and the registry will be changed to reflect current law. Iowa will also introduce it in the next few weeks and minor changes to Subsection F are expected.

Ms. Agrawal asked if, hearing no further comment, the group would like to move the question. Ms. Rosenzweig called the question, and the motion was seconded to recommend that the Secretary of HHS endorse the revised UAGA. The vote was unanimous.

The meeting adjourned at 12:30 p.m.

 


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