|
A peer-reviewed
electronic journal published by the Institute for Ethics and ISSN
1541-0099 18(1)
– May 2008 |
The Elusive Line Between
Enhancement and Therapy
and Its Effects on Health
Care in the U.S.*
Laura Colleton
Journal of Evolution and Technology - Vol. 18 Issue 1 – May 2008 – pgs 70-78
http://jetpress.org/v18/colleton.htm
Introduction
Biotechnology now makes it
possible to enhance human traits as well as treat illnesses and disorders. What it has neglected to establish, however,
is a clear line between these two functions, a distinction between what counts
as treatment or therapy and what counts as enhancement. The bulk of the
literature on enhancements focuses on the ethics of enhancements, not on the
criteria that qualify a procedure as an enhancement (President’s Council on
Bioethics 2003). While the ethical questions regarding the desirability of
enhancements are certainly worthy of consideration, so is the issue of what
constitutes an enhancement versus a form of treatment or therapy. Scholars have
debated the issue of whether a distinction between therapy and enhancement
exists, but the placement of that distinction has not yet been sufficiently
addressed (Sandel 204, 51; Kamm 2005, 5; Schwartz 2005, 17). Much like the
field of bioethics itself, my study of this issue is a work in progress, so
this paper will ask and explore questions relevant to this topic without
providing answers to all of them. Nonetheless, they are important questions to
ask with important implications for the future of bioethics.
This paper will describe the line between enhancement and therapy, map the terrain and define the terms. It will also investigate where the line is at present, and where and how it has been set by legislation and private companies. It will then illustrate the issues, using two examples, to demonstrate the difficulties and complexities involved. Finally, it will explore the implications of the line for society’s financial as well as physical interests, and for healthcare access in the United States. It will conclude by considering the open question of how a company, a government, and a just society should go about setting the line. I hope that asking the questions and exploring their complexities will help draw attention to and prompt serious consideration of the placement of the line between therapy and enhancement.
Defining the Issue: The
Existence and Importance of the Line
Some scholars maintain that
there is no valid difference between enhancement and therapy (Kamm 2005, 5).
Other scholars and I disagree (Sandel 2004; Schwartz 2005). This seemingly
abstract concept has concrete and immediate consequences. Scientists may not recognize this line, but
insurance companies do. They pay for some procedures. They do not pay for
others. Governments discriminate as well: they use Medicare and Medicaid
dollars to pay for some procedures and not others. These entities are making a
distinction, drawing a line. Its placement may be arbitrary, but that does not
mean that no one is making it. Thus, while some scholars may find the line
between therapy and enhancement elusive or even illusory, the practice of
medical care in the United States has created a de facto line that is very real.
One might wonder why this
question is worth debating, why it matters where the line is set. In answer to
that, one commentator writes,
[t]he line that it draws is the boundary of medical obligation. . . . This interpretation has important implications for social policymaking about health care coverage to the extent that society relies on medicine’s sense of the medically necessary to define the limits of its obligations to underwrite care. (Jeungst 1998, 44.)
Thus, the line defines
society’s perception of the scope of legitimate medicine.
Another aspect of the line’s
importance is its role in determining what society views as “normal” and
consequently what it expects of a health care system. The distinction has
effects beyond individuals to society in general, in economic costs as well as
in public health and public perceptions of medicalization. With this much influence over payment and
access to health care, the perceived scope of the medical profession, and issues
of distributive justice, the placement of the line between treatment and
enhancement is well worth considering, debating, and deliberately determining.
Mapping the Terrain
A meaningful examination of
this topic must include a clarification of the terms involved. I shall use the
terms “treatment” and “therapy” interchangeably to mean any substance,
procedure, or other intervention required to correct a disorder or restore a
patient to health. This raises the questions of what qualifies as a disorder or
disease, and what constitutes health. It would be overinclusive to call
anything that inhibits one’s functioning a disorder, but underinclusive to
count only ailments that have been recognized as such for centuries. For the
purpose of this paper, I will define a “disorder” as a condition in which the
patient’s ability to function is well below that of a typical person.
The concept of what restores
a patient to health necessarily entails a definition of “health”. The Compact
Oxford English Dictionary defines “health” as “1) the state of being free from
illness or injury; or 2) a person’s mental or physical condition” (compact OED
website). The World Health Organization offers a considerably more thorough
definition of “health”: “a state of complete physical, mental, and social
well-being and not merely the absence of disease or infirmity” (World Health
Organization website). I will use the term “health” to mean the absence of
injury, dysfunction, disease, or disorder (Schwartz 2005, 17).
Defining “disorder” and
“health” requires one to set the parameters of what the concept of “normal”
includes. Determining these boundaries is difficult and uncertain. Standards of
“normality” often refer to averages, but technologies to alter the average have
become more advanced and more widely available. Still, for purposes of delineating the difference between therapy
and enhancement, I think setting a range around the average is the best proxy
available.
I combine elements of these
definitions to define “enhancement” as a procedure or intervention that aims to
improve a person’s physical or mental health, beyond the level of functioning
that is typical or normal, in the absence of injury, dysfunction, disease, or
disorder, that is, in a healthy person. Though I realize these definitions are
not incontestable, they shall be the meanings of the terms in this paper.
Locating the Line Between
Enhancement and Therapy
Based on the definitions
outlined above, or similar versions of them, the line between therapy and
enhancement is the line where medical necessity stops and optional or elective
procedures begin. But who decides what is medically necessary and how do they
define it? I will now explore several definitions.
Medically
Necessary. In the United States,
medical necessity is a matter of
state law, so governmental definitions of medical necessity will vary. The
Commonwealth of Massachusetts, in which I live, quite helpfully provides not
one but two definitions. According to Massachusetts legislation,
· A service is medically necessary if it satisfies two conditions: 1) it is reasonably calculated to prevent, diagnose, prevent the worsening of, alleviate, correct, or cure conditions in the member that endanger life, cause suffering or pain, cause physical deformity or malfunction, threaten to cause or aggravate a handicap, or result in illness or infirmity; and 2) there is no other medical service or site of service, comparable in effect, available, and suitable for the member requesting the service, that is more conservative or less costly to [MassHealth] (130 Code of Massachusetts Regulations § 450.204(A)).
·
Medical
Necessity or Medically Necessary means health care services that are consistent
with generally accepted principles of professional medical practice as
determined by whether the service:
(1) is the most appropriate available supply or level
of service for the insured in question considering potential benefits and harms
to the individual;
(2) is known to be effective, based on scientific
evidence, professional standards and expert opinion, in improving health
outcomes; or
(3) for services and interventions not in widespread
use, is based on scientific evidence. (105 Code of Massachusetts Regulations
§ 128.020.)
Several large private health insurance companies also assess claims based on medical necessity, and some offer definitions of medical necessity and of their coverage with varying degrees of specificity. The following is a partial list.
- Aetna’s
glossary of health care terms defines medically necessary procedures as
[s]ervices or supplies that are appropriate and consistent with the diagnosis in accordance with accepted medical standards as described in the Covered Benefits section of the plan documents. “Medical Necessity, ” when used in relation to services, shall have the same meaning as “Medically Necessary Services. ” This definition applies only to the determination by the Plan of whether health care services are covered benefits under the plan (Aetna website a).
- Kaiser Permanente’s
website provides more concrete examples. “As a
general rule, members are covered for medically necessary care including
routine medical office visits, health assessments, immunizations, Pap
tests, mammograms, and well-child checkups. Coverage also includes necessary laboratory and radiology
testing, hospitalization, and surgery.” (Kaiser Permanente
website a)
- BlueCross/BlueShield (at least in Massachusetts) begins with
the expansive statement that, “Our plans are just as unique as your health
care needs. We offer a variety of plan designs that offer access to a wide
network of doctors and hospitals dedicated to providing high-quality,
affordable health care.”(BlueCross/BlueShield of Massachusetts website) It then follows that by providing more
specific details based on whether one has an HMO, PPO, or a POS.
- Cigna’s description declares, “[c]overage Positions are only one of the tools
used when a decision is needed regarding whether a particular medical
service is covered for a particular member. (Cigna
website)
Enhancement. One could also locate the
line by examining what these governments and insurance companies say about
enhancement. As far as I could find, neither federal law nor Massachusetts law
defines “enhancement” in this sense. Only one insurance company uses the term
“enhancement.” One of its policies, for example, is that “Aetna considers
androgens and anabolic steroids for performance enhancement not
medically necessary” (Aetna website b). Interestingly, while the insurance
companies are straining to restrict procedures to what is medically necessary,
the pharmaceutical company Pfizer seems to be promoting enhancement
wholeheartedly. It announces, “We dedicate ourselves to humanity's quest for
longer, healthier, happier lives through innovation in pharmaceutical, consumer
and animal health products” (Pfizer, Inc. website).
Disability. Another way to find the line, to approach
the question of what constitutes disease or dysfunction and who truly requires
medical attention, is to turn to the topic of disability. The current, operational legal definition of “disability” in
the Americans With Disabilities Act of 1990 (ADA) focuses on impairment that
limits major life activities (42 U.S.C. 12102(2) (1994)). The
Massachusetts General Laws include a clause about dependency on others for
daily needs (5 Mass. Gen. Laws Annotated 19C §1).
All of these policies,
governmental and corporate, help determine where the line is placed by
articulating a range of views of what is medically necessary and limiting them
based on what similar entities say of enhancements and disability. This still
does not pinpoint the location of the line, for there are many lines, but they
are clustered in the same general area. Thus, we are left with a definite, but
somewhat fuzzy, collection of lines, located beyond disability, right at the
line of medical necessity, but not further.
If setting the line is left
to governments, there will likely be much debate about where it should be, as
governments have responsibilities to their citizens but also limited resources.
If the question is left to private companies, it will largely depend on whether
it is insurance companies or pharmaceutical companies drawing the line, as each
has economic incentives to push the line one way or the other. Regardless of what happens in the future,
the present situation links the line to the contested concept of medical
necessity, beyond disability but before enhancement.
Examples
I next offer two examples of
medical issues that demonstrate the difficulty of setting the line between
treatment and therapy and why this is an issue with such enormous impact. The
two will include one for physical health: chronic pain; and one for mental
health: depression. They make good test-cases for several reasons. Both
conditions exist along a spectrum of severity and a scale that is subjective
for each patient. Both also depend on the patient’s self-description. Finally,
examining the characterization of these two disorders is important and
representative because both are quite prevalent in American society.
Chronic
pain. I begin with chronic pain. At what point on the spectrum of a person’s
pain does it become a disease or disorder? Presumably somewhere between the
occasional headache and daily migraines. A recent
series on NBC Nightly News on “The Mystery of Pain” reported that “many medical
experts call it the country’s No. 1 public health problem: chronic, debilitating pain” (Bazell 2005).
Pain, the fifth vital sign, “is not just a symptom, but a disease” in itself
(Koman 2005, 48, 50). Chronic pain occurs when the “pain message system goes
awry …” (Id. at 46) and “[p]ain signals keep firing in the nervous system for
weeks, months, even years”(National Institute of Neurological Disorders and
Stroke website). The result can have dire consequences. “Untreated pain has
significant impact on the pain sufferer and [his or her] family”(American
Academy of Pain website). The insurance company Kaiser Permanente
recognizes that,
[c]hronic pain – the kind that is almost always with you or that happens frequently – can take its toll on your health, sense of well-being, relationships with family and friends, and ability to work. (Kaiser Permanente website b.)
Unfortunately,
many patients recount tales of insurance companies’ refusal to cover expensive
pain treatments (Koman 2005, 50).
This case provides
interesting insight into the subjectivity, individual and cultural, of
interpreting whether a specific disorder requires treatment or therapy, or
whether treating it would simply be enhancement. On an individual level,
chronic pain is inherently subjective as “the unique characteristics of each
individual impact [his or her] experience of pain” (American Academy of Pain
Management website). This makes it extremely difficult to determine where the
line should be for chronic pain: what might be a necessary treatment for one
person might be an enhancement for another.
On a much broader level,
people in much of the nonindustrialized world believe that pain is an inherent component of living and endure it in silence. . . . In the United States, however, people tend to equate personal freedom and the pursuit of happiness with a guaranteed freedom from pain. (Koman 2005, 51.)
Even within the U.S., people have very different expectations of how much pain one should have to suffer.
The Pain in America: A Research Report done in 2000 found that four out of five Americans believe that pain is a part of getting older, and approximately sixty-four percent would see a doctor only if their pain became unbearable. Sixty percent of the respondents said that pain was just something that you have to live with. (American Academy of Pain Management website.)
Given this subjectivity,
self-reporting, and variation in the level of expectation of pain, it would be
especially difficult to find a single point on the treatment-enhancement
spectrum where chronic pain belongs.
Depression. The second example, depression, is equally
hard, for it too has a spectrum of its own. A particularly difficult question
in this case is baseline: what level of mood is considered “normal” such that
its negative elements do not require treatment? And what level of mood is bad
enough that remedying it with even the most powerful treatments and medicines
could not be considered enhancement?
“Clinical depression is more than just the ‘blues,’ being ‘down in the
dumps,’ or experiencing temporary feelings of sadness we all have from time to
time” (National Institutes of Health website a). “It takes more than just
tearfulness or a feeling of sadness on the part of the client to indicate the
presence of depression” (National Institutes of Health website b). It makes it
easier for insurance companies to require a diagnosis from a mental health
professional in order to recognize the patient’s illness as a disorder. Despite
the ease of this procedure, however, the theoretical questions remain for the
mental health professionals: “[h]ow
happy were we, in fact, designed to be?” (Wolpe 2002, 390). How depressed does
one’s mood have to be and how much loss of interest does the patient have to
have in order for it to count as depression?
Remedies bring questions of
their own. One commentator asks,
If Prozac can lift everyone’s mood, what then becomes “normal” or “typical” affect, and will grouchiness or sadness or inner struggle then be pathologized? And if we can all be happy and well-adjusted through Prozac, should insurance pay for everyone to reach that state of bliss? (Wolpe 2002, 388.)
Thus, both chronic pain and
depression provide examples of how difficult it is to find where therapy ends
and enhancement begins.
V. Implications for Health
Care Access and Societal Costs
In addition to the
perception of legitimacy and scope of medicine issues, the main implication that
answering the therapy-enhancement question has is financial. Determining on
which side of the therapy-enhancement line a service, procedure, or medicine
falls determines who, if anyone, will pay for it. Imagine I go to my doctor, who gives me a prescription for a
medicine. If I am lucky enough to have insurance and the insurance company
agrees that the medicine is therapeutic, then the insurance will pay for it.
If, however, I am one of the 45.8 million people without insurance in America,
I will have to come up with the money myself or forego the treatment (U.S.
Census Bureau 2005). The situation becomes even more complicated if, though I
think the medicine is a treatment, the insurance company decides that it is an
enhancement and therefore will not pay for it. Then, having insurance will not
help me. If I am lucky enough to be able to afford the medicine on my own, then
I get it, but I have to pay for it out-of-pocket. And if I am not lucky enough
to be able to afford it, whether I am insured or not, I simply do not get my
medicine.
Therefore, the outcome of
therapy-enhancement decisions determines who pays, and thus who has access to
certain medicines and services. This impact is especially powerful given, for
instance, the prevalence of the two examples discussed earlier. An “estimated
50 million Americans live with chronic pain caused by disease, disorder, or
accident” (American Academy of Pain Management website). In addition to the
physical cost, the financial cost to society is significant:
The loss of productivity and daily activity due to pain is substantial. In a study done in 2000 it was reported that 36 million Americans missed work in the previous year due to pain and that 83 million indicated that pain affected their participation in various activities. (Id.)
When the issue is
depression, the effect is even more substantial. Depression affects 19 million
Americans each year (National Institutes of Health website a) and it is the
“leading cause of disability in the United States”(National Institutes of
Health website c). Put simply, “[u]ntreated depression is costly” (National
Institute of Mental Health website). “Depression exacts an economic cost of
over $30 billion each year. . . .” (National Institutes of Health website a).
It “counts for close to $12 billion in lost work days each year,” and more than
$11 billion in other costs from decreased productivity (National Institutes of
Mental Health website). Thus, the number of patients and the costs they incur
multiply; and, in a society that does not acknowledge health care as a right
and that has a large gap between people who can afford to pay anyway and people
who cannot, those costs make the difference between access to health care and
none. Especially for those with no medical insurance, but also for those with
insurance who cannot afford to pay out-of-pocket, the access that is granted or
denied based on whether a procedure is deemed a treatment or an enhancement is
crucial. What began as an abstract thought exercise about how to divide some
services from others becomes a million-, perhaps billion-, dollar financial
question, and potentially a matter of life and death.
Conclusion
In conclusion, I would like
to pose some open questions and offer a few ideas about how a society, government,
or company should go about setting the line between treatment and enhancement.
“What standards of ‘medical care’ do we use when we desire to distribute
medical care fairly and equitably in society?” (Wolpe 2002). “What’s need?
What’s want? What are people’s rights? What can we afford to pay?” (Finley
2000, 847). One final issue is how to address the subjectivity issue. Where on
the spectrum the line between treatment and enhancement falls might vary from
person to person, and health care as a whole will have to figure out a way to
assign each person the right spot.
But even if we had answers
to some of these complex questions, other problems would remain. On the topic
of access to medical care, society, government, and private industry must
perform a balancing act. That is not to
say balancing between quantity and quality, but quantity and quantity. The
fewer people, the more services the government or company can provide; but the
fewer services they provide, the more people they can serve. As long as there
is nearly infinite need and limited resources, society will need to establish
and preserve this balance somehow.
The treatment-enhancement
model has flaws, including how to categorize preventive care, the ease of
inventing new maladies, and a vulnerability to overmedicalization. With regard
to all of these challenges, though, I still maintain that the
therapy-versus-enhancement model is the best approximation for distinguishing
what is included in society’s definition of health care and what should be
included in financial health care coverage, public and private. Erik Parens
writes,
Like many distinctions, the treatment/enhancement distinction is permeable, unstable, and can be used for pernicious purposes. If used carefully, however, it can be one tool to start important conversations about the sorts of health care services that a just system of health care should provide. (Parens 1998, S13.)
This issue is incredibly important and I hope this paper will function as just such a tool.
References
Aetna website a, Glossary, available at http://www.aetna.com/help/glossary.html#Necessary.
Aetna website b,
Androgens and anabolic steroids. Clinical
Policy Bulletin No. 0528, 18 Oct. 2005, available
at http://www.aetna.com/cpb/data/CPBA0528.html.
American Academy
of Pain Management website, Pain issues – pain is an epidemic – a special
message from the director, available at http://www.aapainmanage.org.
Bazell, R. What is pain? from MSNBC website, available at http://www.msnbc.msn.com/id/10696210/from/RL.1/.
BlueCross/BlueShield
of Massachusetts website, What our health plans cover, available at
http://www.bluecrossma.com/common/en_US/newMembersIndex.jsp?levelOneCategory=New+Members&levelOneDotFiveCategory=EMPTY&levelTwoCategory=What+Our+Health+Plans+Cover&targetTemplate=titleBody.jsp&repId=EMPTY.
Cigna website, How
medical coverage guidelines are used, available
at http://www.cigna.com/health/consumer/medical/coverage_guidelines.html.
130
Code of Massachusetts Regulations § 450.204(A).
105 Code of Massachusetts Regulations
§ 128.020.
Compact OED
website, available at http://www.askoxford.com/concise_oed/health?view=uk.
Finley, K. 2000.
Life, liberty, and the pursuit of Viagra? Demand for “lifestyle” drugs raises
legal and public policy issues. 28 Capital
University Law Review 837, 847.
Jeungst, E. 1998,
44. What does enhancement mean? In
Enhancing Human Traits, ed. E. Parens.
Washington, DC: Georgetown University Press.
Kaiser Permanente
website a. Getting care at Kaiser Permanente – what benefits are covered, available at www.kaiser.com.
Kaiser Permanente
website b. Managing chronic pain: you
play the central role, available at http://www.kaiser.com.
Kamm, F. 2005. Is
there a problem with enhancement? The
American Journal of Bioethics, May/June 2005.
Koman, K. 2005.
The science of hurt. Harvard Magazine.
November-December 2005.
5 Mass. Gen. Laws
Annotated 19C §1. (Context of the Disabled Persons’ Protection Committee).
National
Institutes of Health website a. All about depression – what is depression?
Publication No. NIH-99-3561, available at
http://www.allaboutdepression.com/gen_01.html.
National
Institutes of Health website b. All about depression – diagnosis of clinical
depression, Publication No. NIH-99-3561, available
at http://www.allaboutdepression.com/dia_01.html.
National
Institutes of Health website c. All about depression – additional statistics
and information about depression. Publication No. NIH-99-3561, available at http://www.allaboutdepression.com/gen_01.html.
National
Institute of Mental Health. The effects of depression in the workplace, available at http://www.allaboutdepression.com/gen_15.html.
National Institute
of Neurological Disorders and Stroke (a part of the National Institutes of
Health) website, Chronic pain information page,” available at http://www.ninds.nih.gov/disorders/chronic_pain/chronic_pain.htm.
Parens, E. 1998.
Is better always good? The Enhancement
Project, A Special Supplement to the Hastings Center Report,
January-February 1998 at S13.
Pfizer, Inc. website,
available at
http://www.pfizer.com/pfizer/main.jsp.
President’s
Council on Bioethics. 2003. Beyond
therapy: biotechnology and the pursuit of happiness. New York: ReganBooks.
Sandel, M. 2004.
The case against perfection. The Atlantic
Monthly, April 2004.
Schwartz, P. 2005,
17. Defending the distinction between treatment and enhancement, The American Journal of Bioethics,
May/June 2005.
U.S. Census Bureau
News website. 2005. Income
stable, poverty rate increases, percentage of Americans without health
insurance unchanged. Press Release on 30 August 2005, available at
http://www.census.gov/Press-Release/www/releases/archives/income_wealth/005647.html.
42 U.S.C. 12102(2)
(1994).
Wolpe, P. 2002,
387, 389 Treatment, enhancement, and the ethics of neurotherapeutics, 50 Brain and Cognition.
World Health
Organization website, available at http://www.who.int/about/definition/en.
* I would like to thank Professor M. Christian Green of Harvard Divinity School for a series of enlightening courses and her support of this work.