[Federal Register Volume 71, Number 116 (Friday, June 16, 2006)]
[Notices]
[Pages 34946-34948]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-9401]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Response to Solicitation on Organ Procurement and Transplantation 
Network (OPTN) Living Donor Guidelines

AGENCY: Health Resources and Services Administration (HRSA), HHS.

ACTION: Response to solicitation of comments.

-----------------------------------------------------------------------

SUMMARY: A notice was published in the Federal Register on January 23, 
2006 (Vol. 71, No. 14, pages 3519-3520). The purpose of this notice was 
to solicit comments 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.

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 (301) 443-7577; 
fax (301) 594-6095; or e-mail: [email protected].

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 and 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.
    In the January 23, 2006, Federal Register notice, comments were 
requested 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. The Secretary explained 
that if he decided 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

[[Page 34947]]

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.
    During the comment period, HRSA received 29 comments from 
individuals affiliated with or representing universities, hospitals, 
professional associations, and living donation advocacy organizations; 
a healthcare accreditation organization; transplant recipients; and 
family members of donors, recipients and candidates. Twenty of these 
comments explicitly referenced changing the status of OPTN living donor 
guidelines. The remaining nine comments expressed views about various 
aspects of the national transplant system not directly related to the 
solicitation of comments.
    HRSA thanks the respondents for the quality and thoroughness of 
their comments. The comments and HRSA's decision are discussed below.

I. Living Donor OPTN Policies Consistent With Other OPTN Policies

    The majority of respondents indicated that OPTN living donor 
guidelines should be given the same status of other OPTN policies. Of 
the 20 comments that explicitly referenced changing the status of OPTN 
living donor guidelines, 17 were supportive of giving OPTN living donor 
guidelines the same status, and subjecting these to the same 
enforcement actions, as other OPTN policies. Supportive comments were 
received from representatives of academia, transplant surgeons, living 
donors who had positive donation experiences, living donors who had 
negative donation experiences, family members of living donors who died 
or who experienced complications as a result of the donation, living 
donation advocacy organizations, transplant administrators, the 
professional societies representing transplant surgeons and transplant 
physicians, transplant candidate/recipient advocacy organizations, the 
organization serving as the current OPTN contractor, and an 
organization that accredits hospitals.
    Supportive comments cited the appropriateness of OPTN involvement 
in policies relating to living donors, including donor evaluation, 
informed consent, evaluation of surgical outcomes and complications, 
protection of living donors, peri-operative care, organ allocation, 
qualifications of transplant programs, and transplant program 
compliance with living donor policies.
    A few comments indicated opposition to giving OPTN living donor 
guidelines the same status as other OPTN policies. A family member of 
two kidney transplant candidates who died on the waiting list is now an 
advocate of potential living donors and recipients meeting on the 
Internet and is opposed to the OPTN's involvement in living donor 
policy making because of the perception that the OPTN discourages 
living donor transplants resulting from such meetings. Another opponent 
of OPTN involvement is waiting for a liver transplant and does not 
trust the OPTN policymaking process because of the perception that 
wealthier candidates receive priority for donor organs. One data 
manager from a large transplant program commented that mandating data 
collection on living donors was unlikely to increase donor follow-up 
form completion rates unless the donors' insurance companies can be 
persuaded to pay for follow-up visits. HRSA appreciates each of these 
comments.

II. OPTN Living Donor Policy Making Authority--Organ Allocation

    Comments supportive of OPTN involvement in living donor policy 
making expressed varying views regarding the scope of policies the OPTN 
should consider. Of the 17 comments that were supportive of OPTN 
involvement, five suggested areas in which the OPTN should not become 
involved. One comment did not advocate an intrusive role for the OPTN 
in the allocation of living donor organs or ethical review of local 
living donor practices. A transplant administrator offered the similar 
caution that altruistic living donors may feel a sense of connection to 
their local transplant center and may not want their organs allocated 
to a distant center. A representative of the professional society for 
transplant surgeons offered a comment to HRSA that the OPTN Final Rule 
does not authorize the OPTN to establish policies for living donor 
organ allocation. In response to this, HRSA emphasizes that its 
authority to direct the OPTN to develop living donor organ allocation 
policies is granted in Sec.  121.4(a)(6) of the OPTN Final Rule which 
permits the Secretary to develop policies on such other matters as the 
Secretary directs. The wording in Sec.  121.8(a) of the final rule 
referring to policies ``for the equitable allocation of cadaveric 
organs'' should not be construed as a limitation of the Secretary's 
policy making authority over living donation.
    A representative of a living donor advocacy organization commented 
that OPTN policies should not interfere with the right of an altruistic 
living donor to direct their organ to a specific individual. We agree. 
Section 121.8(h) of the OPTN Final Rule permits the allocation of an 
organ to a recipient named by those authorized to make the donation. 
Because we are directing the OPTN to develop living donor allocation 
policies under section 121.8 of the final rule, section 121.8(h) will 
apply to living donation equally as it applies to deceased donation.

III. OPTN Living Donor Policy Making Authority--Donor Evaluation

    Supportive comments varied in their level of support for OPTN 
involvement in developing policies for living donor evaluation. Of the 
17 comments that were supportive, two were opposed to OPTN policymaking 
in this area. One comment from a representative of the professional 
organization for transplant surgeons and another from a transplant 
surgeon asserted that the OPTN should not develop policy in the area of 
donor evaluation because there is no clear clinical consensus regarding 
the policies or standards that should be followed. HRSA believes it is 
very likely that should the OPTN consider policy making in the area of 
living donor evaluation that members of OPTN committees and the Board 
of Directors will consider this perspective and abandon policy making 
in the absence of clear clinical consensus. Additionally, through its 
public comment process transplant professionals also have the 
opportunity to advise the OPTN of the lack of clear clinical consensus, 
should it exist.

IV. OPTN Living Donor Policy Making--Living Donor Follow-up

    Several comments stated greater attention should be given to 
understanding the impact of donation on living donors. One commenter 
who represents the professional organization for transplant 
professionals recommended more Federal funding for a live organ donor 
database. A comment from a living donor who is a healthcare 
professional and living donor advocate asserted that there should be 
mandatory policies to protect living donors and a central source of 
outcome data via a living donor registry. A comment from a transplant 
surgeon supports more OPTN involvement in living donor data collection 
and monitoring living donor outcomes. A comment from a representative 
of a healthcare accreditation organization stated it is appropriate for 
the OPTN to establish additional policies to promote the safety of 
living donor transplantation. A

[[Page 34948]]

comment from the mother of a living donor and recipient who both 
experienced post-transplant complications asserted that stronger 
policies should be developed to ensure living donor safety.

Conclusion

    HRSA has reviewed and considered each aspect of each comment and 
has determined that OPTN living donor guidelines should be given the 
same status of other OPTN policies as discussed in the Federal Register 
Notice published on January 23, 2006. Under 42 CFR 121.4(a)(6), the 
Secretary directs the OPTN to develop policies regarding living organ 
donors and living organ donor recipients, including policies for the 
equitable allocation of living donor organs, in accordance with section 
121.8 of the final rule. Thus, the OPTN shall develop such policies in 
the same manner, and with the same public comment process, that it does 
for policies on deceased organ donors and deceased organ donor 
recipients. Non-compliance with such policies shall subject OPTN 
members to the same consequences as noncompliance with policies 
concerning deceased organ donors and deceased organ donor recipients 
developed under the final rule.

    Dated: June 9, 2006.
Elizabeth M. Duke,
Administrator.
[FR Doc. E6-9401 Filed 6-15-06; 8:45 am]
BILLING CODE 4165-15-P