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This treatise, written by Dr. Lance Wyble of Tampa, Florida, was used to help argue the case for state insurance coverage of PKU
medical foods and low protein products.
Should there be a legal requirement of insurance companies to
cover all medically prescribed components (drugs and/or diet)
of a regimen to protect against the damaging and incapacitating
effects of phenylketonuria (PKU)? There are cogent, moral arguments
against even mild barriers to appropriate protein intake following
identification of the inheritance and presence of phenylketonuria
by mandated state screening. There are also compelling arguments
against a policy which allows insurance carriers to refuse coverage
of a specially prepared food item, which is specifically prescribed
for PKU, simply because it does not come in the form of a pill
or shot.
Phenylketonuria is one of a number of metabolic disorders occurring
in I per 10,000 to I per 20,000 births and has been included in
the state of Florida Newborn Screening Program since 1965. Currently
there are I 00 to 120 children and adults being treated for phenylketonuria
or other inherited metabolic disorders in Florida. Undetected
and untreated, phenylketonuria will result in severe mental retardation
in infancy. Although universal screening and milk product substitution
in infancy is now a standard of care, if children with phenylketonuria
and other forms of inherited metabolic disorders amenable to dietary
treatment are not able to maintain strict dietary regimen throughout
their life they become victims of slow, but significant, intellectual
change over the course of their lifetime. This terrible development
can be prevented by following a very strict low protein/vegetarian
diet, which includes specially prepared medical foods (low phenylalanine
formula and specially prepared pastas and breads) to provide the
bulk nutrients lacking in the restricted diet. Because these medical
foods are specifically formulated to treat PKU and other metabolic
disorders, these products are very expensive.
The heart of this problem, now encountered by a family whose child
is diagnosed with PKU, is that in most states there is currently
no policy of insurance coverage of the few very low protein or
no protein metabolic supplements which have now been developed
as staples (such as pasta, baking mix, gelatin desserts, cookies,
and flour). These products broaden the variety of foods an individual
may use to maintain dietary control for PKU. This is particularly
important now that authorities are recommending the diet restriction
of protein should be lifelong. Unfortunately, these products are
also very costly. A 12-ounce box of low protein pasta costs over
$4; a package of crackers over $5; a 14-ounce package of baking
mix that produces one loaf of bread costs over $7. In summary,
these special foods help make a very difficult dietary regimen
tolerable and improve the medical well-being of children and adults
with PKU, but they don't come easily.
The United States government has recently suggested that our economy
can no longer fully afford all the health care that medical science
can bring us. Because infinite needs have encountered finite resources,
we must now plan our spending wisely. Some social commentators
believe that modem genetic diagnosis and technologies has the
potential to foster a new era of medicine. Many have become concerned
that these technologies may become tools of discrimination. Likewise,
legislation on health policy which limits access to health care
for certain diseases or situations could be considered a form
of eugenics.
There is no reasonable question as to what is in the best interest
of infants diagnosed with PKU or other inborn errors of metabolism.
A public policy that grants parents the right to consign their
children to a state of irreversible and variable mental damage,
would have to be perceived as morally unacceptable. Just as it
was long ago decided that requiring parental consent for PKU screening
was intellectually inappropriate, a policy to allow parental choice
because of insurance industry refusal to provide medically indicated
care would have to be questioned. If the principle consideration
is the welfare of children, they are best served by a program
of compulsory and non-exceptional coverage by insurance industry
of medically indicated dietary alterations which affect long term
outcome and ultimate healthy development.
There has been a longstanding tradition granting parents and the
family broad discretion and control over the care and welfare
of children. Most insurance industry representatives respond to
accusations of rationing and the creation of barriers by restating
the philosophical position that the insurance industry only offers
choices and provides cost oriented programs to fulfill the desires
of its consumers. Many health care consumers have feel helpless
to resist the obvious directive of the insurance industry towards
the path of financial least resistance or sometimes least headache.
There is no disagreement about the consequences of "no insurance
coverage for therapy," a therapy which is as indicated as
insulin for a diabetic. The only logical argument which can be
made would request that either government or parents of children
born with inherited defects of metabolism pay for required low
protein food products, instead of insurers. The insurance industry
argument centers around the statement that the industry covers
medicinal products, but cannot be expected to cover a particular
diet. The insurance industry also allows refusal of coverage for
treating diseases if such treatment is experimental and unproven.
In the case of PKU and other inherited defects of metabolism,
no such argument can be made. Since mass screening began around
1965, the positive effect of dietary modification throughout life
has come to be recognized.
As PKU screening has become compulsory, is the State not obligated
to assure that the medical resources necessary for effective treatment
are made available? This would include adequate follow up and
counseling for parents of babies with positive tests, as well
as referral to pediatricians who are experienced in the management
of PKU. By applying the same reasoning, is it possible to generate
a State obligation to finance PKU treatment for infants when the
financing of care cannot be arranged through any of the other
mechanisms (e.g. Medicaid, Crippled Children's Funds, third- party
payers, parental resources, etc.)? It is important to note that
any program of health coverage which in theory has been purchased
for the express purpose of treatment of medical conditions owns
certainly no less a responsibility than the State institution
which mandates diagnosis.
Perhaps these arguments against the current policy position involve a combination of political, pragmatic, and moral considerations. The largeness of the harm involved in the argument over PKU food product provision would seem fairly remote on the statewide scale because of both the relative rarity of the disease and the empirically demonstrated low rate of parental refusal to maintain some attempt at dietary modification. It might, therefore, be reasonable to ask, "Why bother to change industry standards?" That is to say, why bother to buck the prevailing insurance industry policy over compulsory programs. Despite these concerns, I remain deeply skeptical about the moral justiciability of any negative effect attributable to the current policy. Furthermore, policy change mandating, by law, dietary therapy coverage of PKU and other inborn metabolic defects will lead to no attributable risk. It remains to be seen whether my position is sufficiently; compelling to override moral, practical, and political arguments against my proposed change.