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The Administration strongly opposes House passage of H.R. 2418, which would
reauthorize the National Organ Transplantation Act (NOTA). H.R. 2418
raises serious Constitutional issues, would preserve existing inequities in
the organ transplantation system, and could result in potential harm to
patients. If H.R. 2418 were presented to the President in its current
form, his senior advisers would recommend that he veto the bill.
The effects of the current organ allocation policies established by the
Organ Procurement and Transplantation Network (OPTN) are inequitable
because patients with similar severities of illness are treated
differently, depending on where they may live or at which transplant center
they may be listed. For this reason, the Department of Health and Human
Services issued regulations, which became effective March 16th, that
establish a framework for organ allocation policies, to be developed by the
network, that are based on sound medical judgment, and that are fairer and
more equitable for all parties. Unfortunately, H.R. 2418 would not result
in a fairer system for all patients in this country. Rather, it is
seriously flawed legislation because it:
- Does not require the standardization of patient listing practices and
broader sharing of organs, two items that the Administration and the
Institute of Medicine consider essential to ensuring fairness in the
system and optimal outcomes for patients.
- Reduces the appropriate Federal role in overseeing the OPTN, despite
the recommendation from an independent study required by Congress and
conducted by the prestigious Institute of Medicine, that HHS should
have the oversight responsibility "to manage the system of organ
procurement and transplantation in the public interest, and to ensure
public accountability of the system."
- Inappropriately grants extraordinary powers to the private sector to
approve the Federal contractor that manages the OPTN.
- Raises serious constitutional concerns. It is a core constitutional
value that politically accountable Executive Branch officers should
make the important policy judgments necessary to implement a Federal
regulatory scheme. For this reason, the bill's delegation of authority
to a private party to establish standards governing organ transplants
and transplant providers raises serious separation of powers concerns
and would create a significant risk that a court might declare the bill
unconstitutional.
The Administration could support the amendment offered by Representatives
LaHood, Moakley, Rush, Peterson (John) and others. Similar to the current
regulation, it reflects the recommendations made by the Institute of
Medicine in its Congressionally mandated study of organ allocation policies
and it strikes the proper balance between medical judgments being made by
transplant professionals and the need for public accountability for tax
payer funds. It articulates clear principles to guide organ allocation
policy, designed to protect the interests of patients. It assures that
data necessary to evaluate and improve the organ transplant system are
provided to the public. It avoids the serious constitutional problems that
are raised with H.R. 2418. Further, it promotes organ donation, the single
most important factor in dealing with the shortage of transplantable
organs. In sum, if Congress determines that legislation to update the
National Organ Transplant Act is desirable, the amendment offered by
Representatives LaHood, Moakley, Rush, Peterson (John) and others
represents a thoughtful legislative response.
The Administration urges the Congress to develop NOTA reauthorization
legislation that better reflects the recommendations of the Institute of
Medicine and that results in a fairer transplantation system for all
patients in this country and their families.
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