THE PUBLIC ADMINSTRATION OF ORGAN ALLOCATION: MAINTAINING THE PUBLIC – PRIVATE PARTNERSHIP
Martin A. Strosberg
Graduate Management Institute
Union College
Schenectady, New York
and
Ron W. Gimbel
Nelson A. Rockefeller College of Public Affairs and Policy
State University of New York at Albany
We examine the public
administration of the Organ Procurement and Transplantation Network (OPTN),
established by Congress to oversee organ rationing. In specific we examine the
controversy over who has the final say on organ allocation policy. Generated by
increasing demand of organs and apparent geographical inequities in waiting
lists, the controversy has pitted the U. S. Department of Health and Human
Services (DHHS) against the United Network for Organ Sharing (UNOS), the
private contractor operating the OPTN. Based on a case study of DHHS’s efforts
to promulgate an administrative rule regulating organ allocation, we describe
the dynamics of policy making and the political arena. UNOS has claimed that
policy making is best left with the private sector. We conclude that the public
is well-served by maintaining a strong role for DHHS.
In
the United States over 15 people per day die while waiting for a solid organ
transplantation. The stark fact is that there are not enough organs to go
around and the gap between demand and supply is growing. Through law, we have
chosen to explicitly ration the distribution of organs, one of the very few
instances where public policy has embraced this method of allocation. Regulation (i.e., regulating access to
public goods) is our national instrument for allocation. The National Organ
Transplant Act of 1984 (NOTA), reflecting the prevailing social norm that organs
should not be considered a market good, banned the sale of organs for
transplantation and established the Organ Procurement and Transplantation
Network (OPTN) to develop policies for and oversee the distribution of this
scarce public resource. A private and nonprofit organization, the United
Network of Organ Sharing (UNOS), holds the contract from the US Department of
Health and Human Services (DHHS) to operate the OPTN.
In this paper we examine the public
administration of the national organ transplant system. Public administration encompasses much more
than the management activities of government agencies. It recognizes that public administrators are
partners with elected officials in public policy making. It also acknowledges the crucial role of the
private sector in carrying out public policies. Achieving and maintaining an appropriate balance among these
partners within the framework of a democratic society is a continuing
challenge. Here we focus on a
controversy that has upset the balance in the relationship between DHHS administrators
and UNOS. We draw lessons from this
controversy and suggest an appropriate role for DHHS in the partnership.
Although the more than 5000 deaths
per year of patients awaiting transplant are but a tiny percentage of the
nation's mortality, the fact that many of these deaths are preventable and
identifiable endows them with political significance and visibility. Americans have accepted the legitimacy of a
system that, for over fifteen years, has distributed organs on the basis of
what have been considered to be medically justifiable and morally defensible
criteria. In specific, we have balanced principles of utility (e.g., who can
benefit most from a transplant in terms of length and quality of life) and
principles of equity (e.g., who is most in need or who has waited the longest).
Since
its inception, our national organ transplantation system has generally been
perceived to be fair and accountable.
Some have suggested that the transplantation system be used as a model
for national health care reform (Benjamin
et al., 1994). However, over the
past several years the legitimacy of the national organ allocation system has
been undermined by a bitter controversy sparked by geographic inequities in
access to organs. Congress, the
Executive Branch, and some powerful interest groups have been embroiled in an
extraordinary rancorous debate on how to distribute scarce livers, hearts, and
kidneys among local areas and regions so that patients, regardless of geography,
have a fair chance of receiving an organ. In the New York City metropolitan
area, a frequently cited example of the apparent injustice of the distribution
system has been the median wait for patients with blood type O for a liver
transplant: 511 days in New York City versus 56 days in next door cities of New
Jersey. Underlying this debate is an intense competition among transplant
centers over who "owns" donated organs, the outcome of which is
linked not only to extra years of life for desperately ill patients but also to
prestige and revenues for transplant surgeons and facilities.
An important dimension of the
controversy has been the struggle over the balance of power between government
and the private sector partners. During
the Clinton Administration, the chief protagonists were the U.S. Department of
Health and Human Services (DHHS) and UNOS, the private contractor. In specific,
the conflict was brought to a head by DHHS efforts to promulgate an
administrative rule giving the Secretary final say over allocation policy.
Former DHHS Secretary Donna Shalala claimed that the
National Organ Transplant Act of 1984 gave DHHS the authority to oversee the
organ network and have the final say on allocation policy. On the other hand,
leaders of UNOS have argued that Congress originally intended that organ
allocation and sensitive medical and ethical decision making be made privately
by the transplant community organized through UNOS, shielded from direct
government involvement. Congress has been divided on this issue. Ironically,
the current DHHS Secretary, Tommy Thompson, while Governor of Wisconsin,
vigorously and publicly supported the arguments of UNOS.
The blueprint for the OPTN, adopted
by DHHS, came directly from a 1986 report
(Organ Transplantation: Issues and
Recommendations) written by the Task Force on Organ Transplantation. This
25 member blue-ribbon commission was established by NOTA to help implement the
law and deal with unresolved operational and policy issues. At the request of
DHHS and its Office of Organ Transplantation, the Task Force designed the
prototype for the organ procurement and transplantation network detailing
goals, composition of the board of directors with slots allocated to various constituencies
and geographic regions, board responsibilities, organizational components, and
membership requirements.
In
crafting the model OPTN, the Task Force
recognized the requirement to make complex tradeoffs between need for an
organ (medical urgency) and the probability of success of the transplant.
However it did not presume to make recommendations on this issue. Instead, the Task Force recommended a
"thoughtful process of development of policies for organ allocation which
takes into account both medical utility and good stewardship.” (Task Force, 1986, pp.8-9) The OPTN, a broadly representative body, would be the
vehicle for this thoughtful policy making process. In 1986, UNOS was awarded the contract to administer the
OPTN. Headquartered in Richmond, Virginia, UNOS had been formed several years
earlier as the Southeast Organ Procurement Foundation.
UNOS
has a 40-member board of directors composed of transplant surgeons and other
professionals, transplant recipients, and donor family members. The board
adopts policies with organized input from the public and the general membership
that includes transplant programs, organ procurement organizations (OPOs), and
tissue typing laboratories. The policies specify in detail how organs are to be
procured and allocated.
Central
to the harvesting, preservation, and transportation of organs is the OPO, a
publicly funded, not-for-profit organization. An important mission of the OPO,
in cooperation with the medical community and the general public, is to encourage
and facilitate organ donation. There are 62, geographically based OPOs in
United States operating in 11 administrative regions and working closely with
891 organ-specific transplant programs (Institute
of Medicine, 1999).
UNOS, through its Organ Center,
operates a central computer network which links OPOs and transplant centers.
Once a patient is accepted onto the waiting list of a transplant hospital he or
she is registered with UNOS. Through a complex process, the organ donors are
matched to those on the waiting list based on a formula incorporating medical
criteria, i.e., the policies that have been adopted by the UNOS board of
directors.
In a nutshell, DHHS wanted to change
these policies and the policymaking process that produced them. The ensuing
controversy has amply illustrated that our allocation system cannot be
separated from the politics of
"who gets what, when and how." In spite of the centrality of ostensibly objective medical
criteria in allocating organs based on need and effectiveness, students of the
public policy making process will recognize the forces, relationships, and
actors familiar to the American
political arena: interest groups, politicians, and bureaucrats (Strosberg and Gimbel, 2001).
The reliance of the private sector
to carry out a public law is not at all unusual. Kettl (1993) has noted
that the implementation of every policy initiative undertaken by the federal
government since World War II, from Medicare and Medicaid to environmental
clean-up, has been managed through public-private partnerships. Contracting out
to the private sector through competitive bid for the provision of goods and
services has long been the management prescription of American public
administration. In the instance of the
OPTN, Congress through DHHS has chosen to contract out the primary
responsibility for regulating access to a life and death resource.
The
legitimacy of this public-private relationship is buttressed by the esteemed
place of professional authority in American society. Decades ago, Don K. Price (1965)
distinguished four broad functions in government and public affairs --the
scientific, the professional, the administrative, and the political -- each
with its institutionalized estate and its own internal logic and motivations.
Price arrayed the four estates along a continuum with truth and knowledge at
one end, and power and action at the other. The scientific estate, driven by
its pursuit of truth and the advancement of scientific theory, appropriately
ignores all other purposes as irrelevant; the professional estate places this
scientific knowledge to social purposes in the service of its clients; the
administrative estate attempts to advance the general purposes of its political
superiors; the political estate makes decisions based on value judgments,
compromise and power interests (Price,
1965). Although the distance on the
continuum separating politicians on the one end and scientists on the other has
no doubt diminished over the past decades, the relative placement of the four
estates on the continuum has not changed.
The decision by Congress and DHHS in
the mid-1980s to place major responsibility for organ allocation policy making
in the hands of the professional estate follows a long-established pattern in
health politics of ceding public policy making authority to private sector
professional associations (Morone, 1993).
Of course, professional associations, well-served by their lobbyists, are
active and effective in the political arena. However, the dominance of
physicians over medical policy making and subsequent administrative
arrangements is also supported by the widely-shared belief that the medical
professionals are indeed the scientifically trained experts in the service of their
patients, far removed from the power, politics, and action of the political and
administrative estates (Strosberg and
Gimbel, 2001). According to Price, the further toward the truth side of
this ideal-type continuum an estate lies, the more it can be trusted, the less
need for oversight. Is this trust warranted?
This question will be discussed and addressed later.
In
terms of public policy formulation and implementation, the four estates have
come together as a "policy community," a group of political actors,
both governmental and non-governmental, that focus on a particular policy area
(Longest, 1998). Sometimes called
policy subsystems, policy communities are a common feature on the federal
governmental landscape and provide leadership and cohesion in the face of
governmental fragmentation and the lack of strong, well-disciplined political
parties. When they dominate policy formulation, implementation, and policy
modification, they are referred to as "iron triangles," composed of:
(1) House and Senate Congressional committees and subcommittees that have
jurisdiction over a particular policy area, (2) public administrators who
manage programs carrying out policies, and (3) non-governmental organizations
and interest groups focusing on a particular policy area.
Accordingly, the organ
transplantation policy community is composed of: (1) members of various
Congressional committees and subcommittees including the House Energy and
Commerce Committee and its Subcommittee on Health, the Senate Labor and Human
Resources Committee; (2) officials of various administrative sub-units of the
Public Health Service and HCFA (Health Care Financing Administration), the two
main components of DHHS; (3) interest group members and associated lobbyists.
Examples of interest groups are transplant surgeons and other health
professional groups, medical centers and transplant facilities, single disease
associations such as the National Kidney Foundation and the American Liver
Foundation, consumer groups, and last but not least, UNOS, the private
contractor that operates the OPTN and whose members include transplant
professionals, recipients, and donor families (Strosberg and Gimbel, 2001).
The
policy community described above has long dominated the making of organ
transplantation policy. Rettig (1989)
divides transplantation policy into three different areas: (1) Status (whether
the procedure is experimental or non-experimental), insurance coverage, and
reimbursement; (2) Organ acquisition and allocation; (3) Facility certification
(based on procedure volume and qualifications of providers). The programs
associated with these three areas have histories predating NOTA. To a large
extent they are constructed from the elements of the federal ESRD (end stage
renal disease) program whose provisions provided ample precedent for managing
organ procurement and allocation and concomitant problems (Rettig, 1989). One reason for the parallel between organ
transplantation and the ESRD program, which of course includes transplantation
as well as dialysis, is that the alternatives that were considered in policy
formulation were generated by basically the same policy community.
The relationship between the
political estate and the administrative estates is said to be one of master and
servant, i.e., the administration faithfully implements and administers the
laws (policies) passed by Congress. However it is not uncommon for Congress to
pass laws with imprecise or ambiguous objectives. It falls to the experts --the
bureaucrats of the administrative agencies -- to fill in the gaps with the
details so that the law can be implemented. In implementing the law,
bureaucrats, or public administrators, make public policy.
The
federal Administrative Procedures Act of 1946 recognizes that much of
bureaucratic policy making is in fact a quasi-legislative function.
Accordingly, it stipulates the formal procedures for making rules, sometimes
called regulations. The process of administrative rule-making -- public
policymaking -- generally requires publication of a draft of the proposed rule
in the Federal Register as a
"Notice of Proposed Rule-Making (NPRM)" and invites public comment
from parties interested in the law's implementation. Administrative agencies
may hold hearings and modify the rule in response to comments and testimony.
The draft rule may be used to guide implementation of the law until the
"final “ rule is promulgated. Needless to say, Congress may intervene at
any point. If it wants, it can choose to amend the original law, especially
during reauthorization. Some of the same interest groups that are active in the
legislative process are also active in the rulemaking process. It is the
so-called "Final Rule" that ignited a storm of controversy within the
organ transplantation transplant community ultimately involving President
Clinton, Secretary Shalala, top Congressional leaders, the courts, and even
state governors.
To address geographical inequities
and other issues of fairness, DHHS, on April 2, 1998, proposed a Final Rule for
the OPTN. The Final Rule was scheduled to become effective on July 1, 1998,
after a brief period of public comment. As will be explained, this schedule was
not even close to being met.
Rather
than write a detailed set of regulations on organ allocation, DHHS decided to
promulgate performance goals to guide OPTN policy making. In adopting the
performance goal model, used also in many initiatives stemming from the
Government Performance and Results Act, DHHS granted the OPTN considerable
discretion in making allocation policies as long as they met the following
three performance goals:
1.
standardized listing of criteria for placing patients on waiting lists, using
objective and measurable medical criteria;
2.
standardized criteria for determining medical status, also based on objective
and measurable medical criteria, sufficient to differentiate patients from
least to most medically urgent.
3.
organ allocation policies that give priority to those whose needs are most
urgent, with the result that differences in waiting times for patients of like
medical status will be reduced ( U.S.
DHHS 1998, p.3).
DHHS’s proposal to modify OPTN
policies and practices with regard to geographic variability in waiting time
attempted to resolve the question of which "community" should have
first claim on organs, our scarce national resource. During the life of the
program, interest groups have argued on behalf of various claimants including:
the transplant facility, the local OPO service area where the organ was
harvested, the region which encompasses the OPO, the state, and the nation.
Unfortunately, as acknowledged in a 1989 article by Task Force Vice Chair,
James Childress, the 1986 Task Force Report provided little definitive guidance
practically guaranteeing future debate in UNOS over procedural and substantive
policies as they concern the relations among local, regional, and national
communities (Childress, 1989). Nine
years later, Childress (1998), in
testimony before the Joint Congressional Hearing on the DHHS Final Rule for
Organ Allocation, conceded that the interpretation of community has been
excessively narrow and urged a more national scope, subject to the logistics of
organ transport. A 1999 Institute of Medicine Report concluded that, in general,
OPTN policies have favored a local area-first approach to prioritization:
Although
potential transplant patients may select from among most transplant hospitals
in the United States (subject to insurance coverage), under current OPTN
policies the number of organs available to a hospital does not rise or fall as
the number of patients on its waiting
list increase or decreases. Rather, it is largely dependent on the number of
donors in that hospital's OPO area. As a consequence of a
"local-first" allocation policy, most organs leave the local OPO area
only if
there
are no local patients who could use them. (Institute
of Medicine, 1999.p.31)
In 2001,
members of the organ transplantation policy community are still searching for
clarity. However the search has become politicized, popularized, and polarized
(Strosberg and Gimbel, 2001).
The
Final Rule did some other important things. Most importantly it gave the
Secretary the authority to review and ultimately approve OPTN policies. Also,
in an attempt to change the OPTN policy making process, it modified the
composition of the OPTN Board of Directors allowing no more than 50% of the
members to be transplant surgeons or transplant physicians. This action was
taken to moderate the domination of the policy process by transplant
professionals. As will be explained later, their perspective, according to
Robert Veatch, “skews the allocation principles in ways that are not fully
supported by the general public” (Veatch,
2000, p. 278). Finally, to improve
accountability, the Final Rule required that the OPTN provide greater public
access to data detailing characteristics of individual transplant programs as
well as waiting times and rates of non-acceptance of organs.
Ordinarily,
policy communities tend to operate in ways that are mutually reinforcing to its
members. With interests converging, there is little conflict or media
attention. Their insularity diminishes the ability of outsiders to influence
policy. Ripley and Franklin describe conditions that weaken the walls of iron
triangles. Two conditions in particular that have directly applied to the
public administration of organ transplantation are: 1) disagreements arising
among normally friendly members of the policy community that become publicized
and stimulate attention and intrusion from non-members, and (2) high-level
attention from the President or a senior administration official showing particular
interest in the functioning of a program and bringing the overwhelming
resources of the Executive Office of the President to bear on the issues (Ripley and Franklin, 1991). Both of
these conditions were present in the controversy over the Final Rule on organ
allocation.
To the consternation of program
managers and senior DHHS officials, Congress repeatedly delayed the
promulgation of the Final Rule (DHHS had been attempting to promulgate a rule
since the early 1990s). It was not until March 16, 2000 that the Final Rule, as
amended on October 20, 1999 (U.S. DHHS,
2000), became effective. As will be explained, its fate is still not
certain.
What
were the reasons for the controversy and subsequent delay? To begin with,
critics and their Congressional allies claimed that the performance goals
spelled out in the Final Rule were inimical to the network and ultimately to
patients. They also claimed that DHHS had neither the legal nor moral authority
to have the final say over policy making in the OPTN. In essence they argued
that the professional estate should not be subservient to the administrative
estate. Organ allocation decisions lie in the realm of the “practice of
medicine” best left to the transplant community.
UNOS
and many others in the transplant community have taken the position that the
performance regulations of the Final Rule, no matter how broad the delegation
of policy making responsibility, would ultimately lead to the outflow of organs
to distant locations containing the sickest patients and would reduce the local
donation rate, increase cost and travel time, jeopardize the financial
viability of the smaller transplant centers, and increase organ waste when sick
patients fail to realize the benefits of transplantation. To investigate these
claims, Congress turned to the Institute of Medicine of the National Academy of
Sciences. In its 1999 report, the IOM found minimal or inconclusive evidence to
support the claims of the critics of the Final Rule (Institute of Medicine, 1999).
Nevertheless these concerns have remained salient in the political
arena.
Although
UNOS sees itself as the representative of the transplant community, not all
members of UNOS have opposed the Final Rule. Ubel and Caplan (1998) have characterized the controversy
over the Final Rule as a struggle "between the have and have-nots"
and a "battle for supremacy among transplantation centers." In
particular, some of the larger and more well-established transplant centers
with longer waiting lists of sicker patients, most notably the University of
Pittsburgh Medical Center, have strongly supported the Final Rule. As the
number of transplant programs increases and the supply of organs remains
relatively flat, the conflict will worsen. The number of liver transplantation
programs has increased to 125 in 1998 from 70 in 1988. Ironically, many of the
new transplant programs are headed up by transplant surgeons who trained with
Dr. Thomas Starzl of the University of Pittsburgh, the founding father of liver
transplantation.
Both
UNOS and its supporters and the University of Pittsburgh which is leading the
battle for the larger centers, have been active lobbying Congress to intervene
in DHHS rulemaking. Members of Congress have been taking sides not on the basis
of party affiliation but on how the Final Rule might impact the transplant
programs of their states or Congressional districts. In general the states with
the larger transplant centers have favored the rule, e.g., Pennsylvania, New
York, California, Illinois. The
following headline from the Wall Street
Journal (1998) captures the flavor of the contest. "With Livingston Adding Power as Speaker, Fight Gets Tougher
for Organ-Allocation Reform," describes the fate of the Final Rule in
terms of the waxing and waning of the power of various Congressional leaders,
such as former Louisiana Congressman and Speaker Robert Livingston, whose state
contained eight profitable transplant centers. Another opponent of the Final
Rule had been former Congressman Thomas Bliley, chair of the House Commerce
Committee with jurisdiction over the OPTN and whose district is home to UNOS
headquarters in Richmond, Virginia. Needless to say, Congressmen in powerful
positions have many tools at their disposal to delay and thwart implementation
of the rule.
The
opposing factions have put together broad-based coalitions containing
professional associations, single-disease associations, grass-roots consumer
organizations, and even governors. For
example, the University of Pittsburgh leads a coalition composed of the
American Liver Foundation, National Transplant Action Committee, Minority Organ
and Tissue Transplant Education Program, and Transplant Recipients
International Organization. UNOS is
supported by the American Transplant Surgeons Society and the Patient Access to
Transplantation Coalition. State governors and legislatures (e.g., Louisiana,
Oklahoma, Wisconsin) also joined the fray by passing or threatening to pass legislation barring transport of
organs across state lines. Former Wisconsin Governor Tommy Thompson
unsuccessfully sued DHHS claiming that Secretary Shalala overstepped the
authority granted to her by NOTA by implementing the Final Rule. Thompson
feared that Wisconsin, which operates one of the nation’s most effective organ
donation programs, would see a drop in its donation rate when its citizens
realize that organs are to be transported to states with less effective
donation programs.
Both Secretary Shalala and President Clinton took an active
interest on behalf of the Final Rule. The level of interest is somewhat
unusual. President Clinton's involvement has been attributed to the pro-rule
lobbying efforts of David Matter on behalf of the University of Pittsburgh. In
1996, Matter, a long-time friend of Bill Clinton, a major campaign contributor,
and the president of a real estate firm with major connections to the
University of Pittsburgh Medical Center wrote to Mr. Clinton at the behest of
the president of the medical center (Washington
Post, 1996). Although denied by the Secretary, critics claim that DHHS has
doubled its efforts to promulgate the Final Rule in response to presidential
interest.
Not surprisingly, the very public
consequences of organ allocation have generated widespread media attention
focusing on local interest stories as well as the political maneuvering in
Washington. On display, for the entire nation to see, is a bitterly divided
transplant community.
While
political activity in opposition or in support of a rule is certainly not
unusual, one cannot help but be struck by the unusually high level of
antagonism between UNOS and DHHS. Secretary Shalala, in testimony before the
Joint Congressional Hearing on the DHHS Final Rule for Organ Allocation,
"Putting Patients First: Resolving Allocation of Transplant Organs,” made
this extraordinary statement:
Unfortunately,
to this point, UNOS has failed to seize the opportunity by the rule to develop
consensus about policy improvements. In fact, UNOS has gone to great lengths to
preserve the current unfair system. It has launched a cynical political
lobbying campaign against the April 2 rule. This campaign has been
characterized by misinformation and outright falsehoods. The essence of the
UNOS campaign has been to create phantom policies and use scare tactics that have
hospital administrators and patients around the country up in arms. UNOS has
sent form letters, part of a self-described "legislative action kit,"
to surgeons and patients across the country. UNOS has been loud and vociferous
in its lobbying and is working with some of the highest priced public relations
and lobbying firms in town. As a result of their slick lobbying campaign, you
are hearing protests about the April 2 rule (Shalala, 1998, p.77).
Although the Final Rule giving the
Secretary the final say on OPTN policies
took effect in March 2000, the war over the control of organ allocation may
not be over. Congressional reauthorization of NOTA provides new
battlefronts. For example, on April 4,
2000, the House passed the Organ Procurement and Transplant Network Amendments
of 1999 (H.R. 2418) by a vote of 275 to 147. This act, if it were to become
law, would neutralize many of the key provisions in Final Rule and greatly
diminish the DHHS Secretary's control over the OPTN. Needless to say, President
Clinton threatened to veto it. The Senate, which failed to act, had been
working on a compromise during the final months of the Clinton Administration.
Whether or not the provisions of
H.R. 2418 ever become law under a new President and Congress, the positions
taken by the opponents in its debate represent two very different prescriptions
for the oversight role of the Secretary of DHHS with regard to the OPTN.
In claiming the authority to oversee
the network and, if necessary, to overrule OPTN policy making, Secretary
Shalala argued, "The primary reason the Act was passed in the first place
was because the unregulated network was rife with abuses... To say we have no
basis to issue regulations when our authority is clear is a disservice to
Congress, which created the network, and to the patients, whose transplant
bills are paid by the taxpayers” (Shalala,
1998, p.78).
Opponents of the Final Rule and proponents of H.R. 2418 maintain that NOTA of 1984 made no such delegation of power to the Secretary. They argue that NOTA did not authorize the Secretary, through rulemaking, to establish medical criteria, or policies for the Network; such authority was expressly left to the private sector. Rather NOTA gave the Secretary the much more limited role of providing funding by contract for the establishment and operation of the Network in the private sector. Contracts, as explained by Kettl limit departmental oversight:
In
public-private partnerships, contracts replace hierarchy. Instead of a chain of
authority from policy to product, there is a negotiated document that separates
policy maker from policy output. Top officials cannot give orders to
contractors. They can threaten, cajole, or persuade, but in the end, they can
only shape the incentives to which contractors respond (Kettl, 1993, p.22).
Paradoxically,
the net result of H.R. 2418 proponent’s intended insulation of UNOS from DHHS
orders would be to increase reliance on Congressional action as the vehicle to
modify Network policy. However, the expectation was that Congressional action
would reinforce UNOS prerogatives.
Interestingly, the Final Rule forges stronger
linkages directly between the administrative estate and the scientific estate.
As amended on October 20, 1999, the Final Rule follows a recommendation from
the IOM Report calling for the creation of an independent federal advisory
committee. Appointed by the Secretary, the scientists and experts of the
Advisory Committee of Organ Transplantation will provide comments on proposed
OPTN policies and other matters related to transplantation. Thus DHHS could
appeal to members of the scientific estate for "impartial scientific
advice." Advice and support from this quarter is particularly valuable to
DHHS because the scientific estate trumps the professional estate on the
truth-to power continuum.
Another
major argument against the final rule is that organ allocation is best left to
local control. In the words of Congressman (and physician) Tom Coburn,
"... Big Brother should not have the right to tell Oklahomans that they
can't direct an organ for their own State brothers and sisters” (Coburn, 1999, p.5). The federal
bureaucracy is inefficient, unresponsive, overly centralized, too far removed
from the people, and too political.
This view was also shared by
Tommy Thompson while Governor of Wisconsin (Washington
Post, 2000).
On the
other hand, dissenting Congressmen argued in the House Commerce Committee
Report:
Were
H.R. 2418 to become law and somehow survive constitutional challenge, it would
fail to accomplish what its sponsors claim they desire -- insulate the organ
allocation system from politics and bureaucrats. By eliminating Secretarial
oversight, H.R. 2418 simply invests private bureaucrats with absolute
life-and-death authority and the freedom to exercise it in settling their
institutional disputes or professional rivalries (House Commerce Committee, 1999, p. 39).
Robert
Veatch, prominent bioethicist and former chair of the Organ Allocation
Subcommittee of the UNOS Ethics Committee, believes that transplant
professionals have no particular expertise on deciding on the tradeoffs between
utility and equity. These tradeoffs and associated policies are better made by
politicians than transplant professionals (Veatch,
2000). We believe that between the
political and the professional, there must be room for DHHS to play an
essential role as senior partner to the OPTN.
Is DHHS too inefficient,
unresponsive, centralized, and political to be the senior partner in policy
making for organ allocation? Is the OPTN incapable of moving beyond
parochialism on behalf of certain interests to represent the broader public
interest? The answer to both questions is of course no. Both entities have an
important role to play in governing a decentralized organ and procurement and
transplantation network. But a constructive public-private partnership cannot
be maintained if DHHS is limited to the role of contract administrator for the
OPTN, no matter how representative, well intentioned, expert, or trustworthy
the contractor.
DHHS
administrators can give voice to interests that may be only faintly heard by
either Congress or UNOS. According to
Fritschler and Hoefler (1996), a
federal bureaucracy with policy-making powers, in concert with Congress,
assures Americans of a more broadly representative decision-making process.
Unlike members of Congress, who frequently have to answer to a narrow
constituency, often well-financed and well organized, administrators can take a
broader view of an issue if they wish. "America's rather unique
combination of bureaucratic and congressional policy making powers can make
important contributions to a system of government based on checks and balances
in which expanded participation in democratic policy making is the goal” (Fritschler and Hoefler, 1996, p.150).
Checks
and balances will serve to constrain “big brother” in Washington from
arbitrarily and capriciously telling Oklahomans how to allocate their organs. However,
DHHS is certainly not a monolithic department. With responsibility for managing
over 300 programs, DHHS is highly decentralized, frustrating efforts by the
Secretary to lead the Department though command and control management. Without
question, the complex and controversial programs cannot be insulated from
external policy, management, and political pressures (Radin, 1999). But these pressures, exerted through legislative,
judicial, and executive branch channels, act as external checks on bureaucratic
power. More often than not, public administrators responsible for managing
programs respond to Congress and its budget appropriations and authorization
processes, legislative oversight, and casework. Administrative actions are
subject to judicial review on procedural or substantive grounds.
There
are also important internal checks on bureaucratic power and policy making. The
making of rules -- policies -- must be done according to the Administrative
Procedures Act. During the long gestation of the Final Rule, there were plenty
of opportunities for public participation in the rule-making process. The Final
Rule of April 2, 1998, as amended on October 20, 1999 (U.S. DHHS, 2000), reflects a responsiveness to public comment and
pressure. Finally, as was mentioned previously, administrators, as opposed to
Congressmen, can take a broader view of an issue if they wish. It
is certainly plausible that public administrators, professionals in their own
right, are internally motivated to seek out the public interest.
Of
course the system of external and internal checks and balances will not
guarantee responsive bureaucracy. Certainly checks and balances can lead to
bureaucratic inaction and paralysis. Special interests can still overwhelm and
capture the bureaucratic policy making process. And the exercise of arbitrary
and capricious behavior is always a danger. However, it would be a mistake to
remove the bureaucracy from the decision making loop. On balance, the
maintenance of DHHS as a strong partner in the public administration of our
national organ transplantation program will encourage openness in the public
policy making process and enhance public support for the OPTN and its resource
allocation role.
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Martin A. Strosberg, Ph.D., is Professor of Management and
Director of the MBA Program in Health Systems Administration at Union College
in Schenectady, N.Y. He previously served as Senior Program Analyst in the
Office of the Assistant Secretary for Planning and Evaluation, U.S. Department
of Health and Human Services.
Ronald W. Gimbel, M.A., is a doctoral
student at the Nelson A. Rockefeller College of Public Affairs and Policy,
State University of New York at Albany. He is currently serving as Director of
the Center for Public Performance and Accountability at the Graduate Management
Institute of Union College.