E6-661. Health Resources and Services Administration; Organ Procurement and Transplantation Network Status of Living Donor Guidelines

AGENCY:

Health Resources and Services Administration (HRSA), HHS.

ACTION:

Request for public comment.

SUMMARY:

The purpose of this solicitation of comments is to assist HRSA in determining whether criteria developed by the Organ Procurement and Transplantation Network (OPTN) concerning organs procured from living donors, including those concerning the allocation of organs from living donors, should be given the same status, and be subject to the same enforcement actions, as other OPTN policies.

DATES:

Written comments must be submitted to the office in the address section below by mail or e-mail on or before February 22, 2006.

ADDRESSES:

Please send all written comments to James F. Burdick, M.D., Director, Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration, Room 12C-06, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857; telephone [phone]; fax [phone]; or e-mail: [e-mail].

FOR FURTHER INFORMATION CONTACT:

James F. Burdick, M.D., Director, Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration, Parklawn Building, Room 12C-06, 5600 Fishers Lane, Rockville, Maryland 20857; telephone [phone]; fax [phone]; or e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Congress has provided specific authority under Sections 372 of the Public Health Service (PHS) Act, as amended, 42 U.S.C. 274 for the creation of a national OPTN, which is, among other things, to facilitate a donor and recipient matching system; establish membership criteria and medical criteria for allocating donated organs; and provide opportunities to members of the public to comment with respect to proposed criteria.

The OPTN Final Rule (42 CFR part 121) governs the operations of the OPTN and is intended to help achieve the most equitable and medically effective use of human organs that are donated in trust for transplantation. Under the final rule, the OPTN is to develop policies on a variety of issues, including “[p]olicies for the equitable allocation of cadaveric organs [now referred to as deceased donor organs].” 42 CFR 121.4(a)(1). Under the final rule, allocation policies developed by the OPTN under section 121.8 of the final rule will be considered enforceable when and if the Secretary approves the policies as such. Enforceable OPTN policies are subject to the sanctions described in section 121.10(c)(1) of the final rule. Non-enforceable OPTN policies may still be subject to lesser sanctions by the OPTN (e.g., an OPTN member being designated a member not in good standing).

Although the authorizing statute does not distinguish between transplants using organs from living donors from those using organs from deceased donors, the final rule does not include a requirement that the OPTN develop policies concerning the equitable allocation of living donor organs. Until recently, OPTN policies have predominantly focused on issues related to organ donation and transplantation of deceased donor organs.

However, several widely publicized living donor deaths have caused the OPTN to implement new practices of reviewing and approving, on an advisory basis, the qualifications of living donor transplant programs. Additionally, the increased incidence of altruistic living donations has prompted the OPTN to consider policies that are patient-focused yet address the unique circumstances pertaining to the recovery and transplantation of living donor organs. Section 121.4(a)(6) of the final rule provides that the OPTN shall be responsible for developing policies on a variety of topics, including “[p]olicies on such matters as the Secretary directs.” In accordance with that authority, the Healthcare Systems Bureau directed the OPTN to develop allocation guidelines for organs from living donors and other policies necessary and appropriate to promote the safety and efficacy of living donor transplantation for the donor and recipient. It further advised the OPTN that all living donation policies (other than data reporting policies) should be considered as best practices or voluntary guidelines and not subject to regular OPTN sanctions (even those available with respect to violation of non-enforceable policies) until the public has had an opportunity to comment on the matter.

The purpose of this solicitation of comments is to assist HRSA in determining whether OPTN living donor guidelines should be given the same status of other OPTN policies, i.e., be treated as policies developed in accordance with 42 CFR 121.8, and be subject to the same enforcement actions. If the Secretary decides these questions in the affirmative, OPTN policies relating to living donors would be treated the same as other OPTN policies developed in accordance with section 121.8 of the final rule. In other words, OPTN policies concerning living donors would not be considered enforceable policies under section 121.10 of the final rule, and violations of such policies would not be subject to the sanctions described in section 121.10(c)(1), unless and until the Secretary approved such policies as enforceable.

Dated: January 13, 2006.

Elizabeth M. Duke,

Administrator.