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Federal register to solicit comments on OPTN oversight of living donor guidelines

Published on: Saturday, January 21, 2006

To: OPTN board of directors, OPTN committee members, liver and kidney transplant program directors, liver and kidney transplant administrators, UNOS Representatives, OPO medical directors, OPO executive directors, and transplant association and society executives.

From: Francis L. Delmonico, M.D., OPTN/UNOS President and Walter Graham, Executive Director, UNOS

Re: Federal Register to solicit comments on OPTN oversight of living donor guidelines

Date: January 23, 2006

HRSA has published a notice in the Federal Register to solicit comments on OPTN oversight of living donor guidelines. The notice soliciting comments on the living donor guidelines was published in the Federal Register today, January 23 (Volume 71, Number 14, Page 3519-3520). Written comments must be submitted to Dr. Burdick by mail or e-mail on or before February 22, 2006.

At its last meeting, the OPTN/UNOS Board of Directors requested that HRSA take this action to give OPTN live donor policies the same status as other OPTN policies. During 2003 and 2004 the OPTN/UNOS Board of Directors approved criteria for qualified live donor liver and kidney transplant programs and approved requirements for the submission of data to the OPTN in the event a live donor suffers an adverse event subsequent to surgery.

The authority for the OPTN to develop and implement such policies and standards is described in the attached letter dated October 29, 2004, from the Health Resources and Services Administration, Department of Health and Human Services (HHS). That letter states,

"However, the Final Rule also provides that the OPTN shall be responsible for developing policies on a variety of topics, including '[p]olicies on such other matters as the Secretary directs." In accordance with the authority, HRSA, HSB, DoT is directing the OPTN to develop allocation guidelines for organs from living donors. These guidelines should be limited to the allocation of organs from living donors made to an anonymous pool, and not to organs procured in connections with directed donations. The DoT also is directing the OPTN to develop other voluntary policies/guidelines (not pertaining to organ allocation) it believes necessary and appropriate to promote the safety and efficacy of living donor transplantation for the donor and the recipient."

With respect to the OPTN's ability to enforce such policies and guidelines the letter acknowledges that enforcement of data submission requirements is covered separately. In a letter from the Health Services Bureau of HRSA dated June 10, 2005, the OPTN is advised that submission of data is required by the Final Rule for data submitted on OMB approved data forms and membership applications. Therefore, the OPTN is authorized to enforce data submission requirements for live donor transplantation in the same manner as other OPTN data submission requirements.

The October 29, 2004 letter provides the OPTN with an ability to enforce other authorized live donor policies and guidelines by referring noncompliance to HHS in the event such noncompliance poses a threat to public health or safety:

"All OPTN policies on living donation (other than data reporting policies) should be considered as best practices or voluntary guidelines and not subject to regular OPTN sanctions. In the event a member fails to abide by best practices/voluntary guidelines developed by the OPTN, appropriate responses the OPTN could take may include a public statement of such non-compliance or referral to the Department of Health and Human Services in the event that the practice poses a threat to public health or safety. If you wish living donor guidelines to have the same status as other OPTN policies we would want to issue a Federal Register notice inviting public comment on that matter."

In considering these matters the Board of Directors concluded that the OPTN, its members, and patients and living donors would be best served by the OPTN having the ability to pursue compliance with all authorized live donor policies, guidelines and standards using the OPTN's normal due process and peer review mechanisms, as well as options for adverse action in the event of non-compliance. This would give the OPTN a variety of mechanisms for ensuring compliance rather than limiting the OPTN to the measures of public notification and referral of the matter to HHS for possible adverse action. The Board therefore adopted the following resolution:

Resolved, that the Board of Directors does hereby respectfully request that HHS issue a Federal Register notice stating that living donor guidelines developed by the OPTN in accordance with the policy development process described in Section 121.4 of the OPTN Final Rule (42 CFR Part 121) shall have the same status as other OPTN policies, and inviting public comment on the matter.

Please give this matter your attention. You are encouraged to submit comments to Dr. Burdick as provided in the related Federal Register notice.