ASTP's position statement on the
final rule to govern the OPTN
Date posted on the Web: October 7, 1998
August 20, 1998
John L. Nelson
Associate Director, Office of Special Programs
Health Resources and Services Administration
12420 Parklawn Drive -Room 123, Park Building
Rockville, MD 20857
Dear Associate Director Nelson:
On behalf of the American Society
of Transplant Physicians (ASTP), I thank you for the opportunity
to comment on the final rule published in the Federal Register
on April 2, 1998, regarding the governance of the Organ Procurement
and Transplant Network (OPTN). The ASTP is the largest professional
transplant organization in the United States and represents
over 1,200 physicians, surgeons and scientists. The ASTP and
its broad-based membership is dedicated to the development
and delivery of patient care, basic and clinical research,
and patient, professional, and public education in the fields
of organ and tissue donation and transplantation.
In formulating a response to these
regulations, the ASTP solicited comments from its general membership
and its standing committees. As reviewed by the ASTP Public
Policy Committee and subsequently the ASTP Board of Directors,
this position is a synthesis of these deliberations to date.
In general, the ASTP strongly supports
the three principles enumerated in the preamble of this regulation
and by the Secretary of the DHHS in numerous correspondences.
These principles are 1) the need to increase organ donation;
2) the need for equitable access to transplantation; and 3)
the need for the leadership role of the OPTN in the formulation
of organ transplantation policies. The ASTP agrees that these
principles are paramount and provided the framework upon which
we analyzed the statedintentions of the DHHS as well as the
actual regulatory language within the rule.
It is also important to emphasize
that the problems we face in the allocation of organs and tissues
for transplantation, a precious and scarce resource, are complex,
and that many relevant and critical issues are still evolving
from both a medical and a policy perspective. Creating new
regulations or making a policy change in one area may have
adverse and unforeseen consequences in another. We must work
together as the transplant community, broadly defined, to ensure
that all proposed changes in policy and solutions to current
problems represent positive steps for patients and their families.
To that end, it is imperative to move past negative rhetoric
and divisiveness. It is time to articulate constructive suggestions
for improving these regulations, where needed, and preserving
that, which is desirable. The ASTP believes our statement is
an important step in that process.
Increasing Organ Donation
The ASTP applauds the Secretary's
efforts to date to increase organ donation. The ASTP stands
ready to assist the Secretary in any and all efforts in this
area. As we all know, this is the real answer to dealing with
the dilemma of allocating and distributing an inadequate supply
of organs. We urge the Federal government to continue to take
on a greater leadership role in this most important component
of the problem through increased research funding, public education
and awareness campaigns, and implementation of the hospital
participation in Medicare and Medicaid regulations requiring
notification of potential donors to the organ procurement organizations
(OPO). The ASTP offers its skills and strengths as an active
partner with the Secretary in these efforts.
Development of Policies for the
Allocation of Organs
The ASTP agrees with the statement
in the preamble of the rule that professionals in the transplant
community must operate the transplant network. This statement
then goes on to say that transplant professionals in an open
environment should develop the allocation policies as well
as the other policies of the OPTN. In its comments dated December
1996 the ASTP expressed support for the retention of the current
system of policy making reserved for the private sector OPTN
contractor. The ASTP believes that the statement in the preamble
of the regulation supports the current system. We commend the
DHHS for recognizing and codifying the role of the OPTN in
policy development. In addition, the ASTP would ask that DHHS
consider supporting the OPTN in its efforts to reach out to
all of the transplant community by holding jointly sponsored
focused consensus conferences on organ specific allocation
policies to give the OPTN a mandate from the broad-based transplant
community and direction for change.
DHHS Oversight Role
The ASTP has long held the position
that DHHS has an important oversight role, but believes that
this must be recognized as being distinct from a rule which
dictates medical practice. As we will discuss in a later section
of this paper, we believe that asking the transplant community,
broadly defined, to develop policies, but then reserving the
right to discard them entirely, may not be the optimal way
to develop consensus and provide a constructive oversight role.
Allocation Policies to Achieve Performance
Goals
In the regulation published April
2, 1998, section 121.8 Allocation of Organs, lays out the requirements
that must be met by the organ-specific policies crafted by
the OPTN for the equitable allocation of cadaveric organs.
These requirements or performance goals are:
- Standardization of minimum listing
criteria for transplant candidates;
- Standard criteria for determining
medical status, with the status categories being ordered
from most to least medically urgent. The criteria shall be
expressed, to the extent possible, through objective and
measurable medical criteria;
- Organ allocation policies and
procedures shall be in accordance with sound medical judgement,
shall allocate organs in order of decreasing medical urgency
status, avoid futile transplantation and the wasting of organs,
and promote efficient management of organ placement.
The ASTP is concerned that it is
inappropriate and counter-productive to broadly apply these
performance goals to all types of solid organ transplants without
regard for the unique medical issues which distinguish them.
For example, standardizing criteria for determining medical
acuity is most appropriate for life saving organs like hearts,
livers or lungs, but such ranking does not have equal validity
when applied to life enhancing organs like kidneys or pancreata.
In addition, these performance goals appear to underestimate
the significant practical, logistical, and financial implications
surrounding organ allocation and distribution. We urge DHHS
to seek additional input from the transplant community regarding
equity versus urgency and utility versus urgency in an effort
to further refine these performance goals. However, we do commend
DHHS for moving in a direction that is more performance based
with increased accountability.
Our views and comments per requirement
or performance goal are as follows:
Standardization of minimum listing
criteria for transplant candidates
The ASTP strongly agrees with the
provision calling for standardized listing criteria. As DHHS
is aware, the ASTP held a series of organ-specific consensus
conferences in December 1996 and January 1997 for the explicit
purpose of developing uniform listing criteria by organ. The
proceedings from these conferences will be published shortly
in the scientific journal, Transplantation. Only when standardized
listing criteria are universally applied by all transplant
centers will waiting times become more interpretable as one
measure of the equity of allocation policies. Even the current
computer models would need to be re-calibrated to reflect uniform
listing criteria, if they are to be found truly reliable.
In fact, this is an example of where
the transplantation community recognized a need and acted appropriately.
The ASTP has held four consensus conferences and invited representatives
from all aspects of the transplantation community , representing
all solid organ systems. The heart and kidney committees of
the OPTN met and developed policies that were subsequently
approved by the OPTN Board. While difficult, the Liver and
Intestinal Organ Transplantation Committee of the OPTN crafted
general listing criteria for those seeking a liver transplant,
as well. As of 1997, OPTN approved listing criteria for all
organs were in place. We now need to begin the process of monitoring
compliance and further refinement of these listing criteria.
The areas of compliance
and the enforcement of sanctions for non-compliance are areas
in which
DHHS can take a leading role. The enforcement of sanctions
for non-compliance, with non-compliance being defined by the
broad transplant community, is definitely an oversight role
and one for DHHS. The ASTP would support DHHS providing the "teeth" for
OPTN policies.
Standardize criteria for determining
medical status, with the status categories being ordered from
most to least medically urgent. The criteria shall be expressed,
to the extent possible, through objective and measurable medical
criteria.
The ASTP has presented comments
in the past regarding the need for defining severity of illness
and its role in determining priority for transplantation. The
ASTP supports the concept, articulated by this performance
goal, that objective medical criteria be utilized by all transplant
centers to determine the severity of a patient's illness. However,
while this performance goal may be relevant to livers, it likely
is not relevant to those in need of a kidney transplant, because
of an alternative treatment, dialysis. We recommend that DHHS
examine this performance goal as it relates to life enhancing
versus life sustaining organ transplants. We would be happy
to help DHHS to organize a meeting on this issue.
Organ allocation policies and procedures
shall be in accordance with sound medical judgement, shall
allocate organs in order of decreasing medical urgency status,
avoid futile transplantation and the wasting of organs, and
promote efficient management of organ placement.
The ASTP believes that we should
afford all appropriate transplant candidates similar opportunities
for organ transplantation within comparable time periods, taking
into consideration similarities and dissimilarities in medical
circumstances as well as technical and logistical factors in
organ distribution. The ASTP strongly supports this concept
and believes that patients should not be disadvantaged by geography.
There have been calls for and much confusion over a national
transplant list. A single list is not scientifically feasible
owing to brief viability in cold preservation. Moreover, the
ASTP agrees with the recent declaration of the UNOS liver and
intestinal organ transplant committee that a single national
list for liver allocation is also not presently feasible. However,
the disparity found in access and waiting times within regions
must be addressed. We commend DHHS for addressing these disparities
and for supporting the position that policies requiring medical
expertise and the organ transplant professionals who comprise
the organ network should formulate judgment.
While current preservation technologies
have not advanced sufficiently to allow prolonged preservation
of hearts and lungs, this does not negate the possibility of
regional allocation schemes for livers and kidneys with sufficient
flexibility to adapt to changing circumstances. A system based
on regional allocation is preferable to one based on national
allocation and can be structured to address some of the perceived
inequalities present in the current system while maintaining
good outcomes. In addition, we urge DHHS to permit some experimentation
and demonstration projects for regions in the U.S. when establishing
the appropriate sharing areas.
Finally, the ASTP would urge DHHS
to ensure that organ retrieval is disassociated from organ
allocation. The use of OPO boundaries as the basis of organ
allocation has proven to be ineffective. Also, any policies
regarding the allocation of one type of solid organ should
be formulated in such a way as to avoid any negative impact
on the allocation of other organs.
Secretarial Review and Appeals of
OPTN Policies
The ASTP has some concern regarding
the process outlined in the regulation for secretarial review
and appeals of OPTN policies. The process that is being described
seems adversarial in nature. We believe that in this case the
role of DHHS should be to first promote consensus development.
We are concerned that the Secretary is asking the transplant
community to develop policies, while reserving the right to
discard them entirely. It seems there should be a better system
whereby DHHS can be a catalyst when consensus fails to develop.
The ASTP has been a consistent supporter of secretarial oversight,
and we volunteer to help the secretary to develop a process/system
that is based on consensus for the review of OPTN policies.
We would suggest the establishment of an independent body,
comprised of experts in the relevant fields, to provide leadership
in this area. We are concerned that the break down in communication
between the OPTN-contractor, UNOS, and the DHHS has reached
a level that could be detrimental to future federal policies
regarding organ donation and transplantation, thus negatively
impacting patients and their families.
Composition of the OPTN Board of
Directors
The ASTP is a strong supporter of
transplant recipients, family members, donor families, and
other interested members of the general public being members
of the OPTN board of directors. In addition, it is important
that all members of the transplant team be represented on the
OPTN board of directors, from OPOs to transplant coordinators
to histocompatibility experts. The current OPTN board of directors
reflects the composition as defined in the regulations dated
April 2, 1998.
However, the ASTP would suggest
that given the scientific and technical nature of organ transplantation,
transplant physicians and surgeons should constitute 50 percent
of the OPTN board of directors.
Finally, as a measure to facilitate
communication and coordination between the OPTN and DHHS, the
ASTP urges the secretary to assign staff from the Division
of Organ Transplantation and the Health Care Financing Administration
to regularly attend the board meetings of the OPTN and interact
with the OPTN leadership.
Membership in the OPTN
The ASTP would ask that DHHS state
in the regulations, requirements that transplant hospitals
must meet, in regard to trained personal, prior to being admitted
or retained as members of the OPTN. The stated allowance that
mere participation in the Medicare and Medicaid programs may
be sufficient for membership into the OPTN is too open-ended.
This could lead to misinterpretation regarding the necessity
for highly trained professionals in order for an institution
to maintain a quality transplant program.
Review, Evaluation, and Enforcement
of OPTN Policies
The ASTP commends DHHS for providing
a mechanism to enforce the policies of the OPTN. The ASTP has
long felt that for the policies of the OPTN to truly be effective,
there needed to be consequences for non-compliance. However,
we want to be sure that there is due process and a system whereby
corrective actions can be taken, prior to any punitive action,
such as a transplant hospital losing its ability to participate
in the Medicare and Medicaid programs.
ASTP continues to believe that we
need a better understanding with more accurate data of the
present situation regarding organ allocation and donation.
Modeling different allocation schemes has in the past provided
the OPTN important data which was subsequently used to compare
different allocation policies. It is important that these simulations
be rerun using the most current parameters consistent with
the stated performance goals of the final rule so the community
can better understand the potential impact of the regulations
on equity and utility measures. This modeling should be completed
prior to the October 1, 1998 implementation date. In addition,
DHHS may want to consider obtaining an objective analysis of
the current system and the new regulations by an expert panel
under the direction of the Institute of Medicine or the National
Institutes of Health.
Public Access to Data
ASTP agrees with DHHS that physicians,
patients, and the public should have access to accurate, understandable,
and timely information regarding transplant center performance.
We believe that data should be collected annually, and be made
available to DHHS and the public within one year after the
data collection period. We agree that these data should include
general transplant center and program information, actuarial
patient and graft survival rates, rates of re-transplantation,
waiting times, rates of non-acceptance of organs, and other
data that would be helpful for physicians, patients, and their
families in making transplant decisions. The transplant community
must be given the opportunity to review and present the data
in such a manner as to avoid misinterpretation. DHHS must provide
assurances that patient confidentiality will be preserved.
Better Coordination between DHHS
Agencies
The ASTP urges the Secretary to
better coordinate the policies on transplantation and organ
recovery within the various agencies of the DHHS. It is not
optimal for the Health Resources and Services Administration
(HRSA) to be advocating broader sharing areas, while the Health
Care Financing Administration (HCFA) is approving re-definitions
of OPO service areas and transplant center affiliations to
principally impact organ allocation. This does not help to
achieve the ultimate goal of increasing organ donation.
Conclusion
The ASTP would like to thank DHHS
for the opportunity to provide this statement in response to
the final regulations published on April 2, 1998 in the Federal
Register.
Again, the ASTP would like to emphasize
that the problems we face in the allocation of organs and tissues
for transplantation, a precious and scarce resource, are complex,
and the issues are still evolving from both a medical and a
policy perspective. We must work together as the transplant
community, broadly defined, to ensure that all proposed changes
in policy and solutions to current problems represent positive
steps for patients and their families. To that end, it is imperative
to move past negative rhetoric and divisiveness. It is time
to articulate constructive suggestions for improving these
regulations, where needed, and preserving that, which is desirable.
The ASTP looks forward to additional dialog regarding this
regulation and volunteers its membership and their expertise
to DHHS.
Sincerely,
John F. Neylan, M.D.
President
