Medical Necessity - American Health Lawyers Association

for CAM). The percentage of therapies
classified as having positive
or a possibly positive effect was
approximately equal for both CAM
and conventional medical therapies
(41.3 percent for conventional
medicine versus 38.4 percent for
CAM). It is important to note here
that the studies were conducted at
different times and, thus, were
based on different sets of
Cochrane reviews. The study of
conventional medicine includes
only reviews published in The
Cochrane Library in 1998, while
the evaluation of CAM therapies
by the IOM committee included
reviews published in the 2004
issue, which has expanded and
developed significantly since
1998. 45
The definition of medical necessity
recently adopted by state of
Tennessee’s TennCare program is
highly congruent with the recommendations
of both the White
House Commission on CAM and
the Institute of Medicine report.
To be medically necessary under
the TennCare program, a therapy
must:
■ “be required in order to diagnose
or treat an enrollee’s
medical condition”;
■ “be safe and effective” – i.e.,
“the reasonably anticipated
medical benefits of the item or
service must outweigh the
reasonably anticipated medical
risks based on the enrollee’s
condition and scientifically
supported evidence”;
■ “be the least costly alternative
course of diagnosis or treatment
that is adequate for the medical
condition of the enrollee;”
(including “where appropriate,
no treatment at all”); and
■ have “adequate…empiricallybased
objective clinical scientific
evidence of its safety and effectiveness
for the particular use in
question.” 46
There is some irony in the fact
that more CAM interventions
probably would be deemed
medically necessary under the
TennCare program’s definition of
medical necessity than under definitions
of medically necessity that
require acceptance of a therapy
within the medical community.
This is especially true when the
record of conventional medicine
for safety and effectiveness is
reviewed.
For example, FDA-approved
prescription drugs have been
found to have serious safety problems
that become evident only
after the drugs had been on the
market for an extended period of
time. 47 Some experts estimate that
more than 100,000 people in the
U.S. die from adverse drug reactions
resulting from routine
prescription drug use each year.
This number does not include
deaths resulting from medication
errors (i.e., avoidable adverse drug
reactions). 48 A study conducted by
Oxford University scientists
suggested that fatal adverse drug
events rank from the fourth to the
sixth leading cause of death in the
USA after heart disease, cancer,
and stroke, and similar to
pulmonary disease and accidents.
Costs associated with adverse drug
events were estimated at up to
$4 billion a year. 49 In the last few
years, important studies have challenged
the effectiveness of high
dose chemotherapy and bone
marrow transplantation for breast
cancer, 50 arthroscopic surgery for
osteoarthritis of the knee, 51 and
hormone replacement therapy
during menopause. 52 Furthermore,
autologous bone marrow transplantation
and hormone replacement
therapy were found to entail
significant risks to patients. In the
case of hormone replacement
therapy, the therapy increased
risks for cardiovascular disease and
other pathology it was touted as
preventing.
There are several policy options in
assessing the medical necessity of
CAM. One commentator has
suggested that health plans should
not cover CAM, except for therapies
that have been proved safe
and effective (which are, presumably,
medically necessary).
Otherwise, valuable health care
dollars will be diverted to pay for
“interventions for which evidence
of efficacy is either non-existent or
merely anecdotal.” Furthermore,
the fact that a health plan covers a
therapy signals to the market that
it has “a potential health benefit,
that it is medically appropriate in
the circumstances for which it is
covered, and that it is medically
necessary.” However, when reliable
evidence becomes available that a
particular CAM therapy is effective,
compares favorably to the
conventional alternatives, and is
cost-effective, it should become the
standard of care and should be
covered by health plans. 53 One
potential criticism of this option is
that it appears to contain an
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