On July 15, 2004, the
Department of Health and Human Services'Centers
for Medicare and Medicaid Services (CMS)
announced a change in the Coverage Issues Manual
(CIM). The change was from the statement
"obesity is not considered an illness"to
"obesity may be caused by medical conditions
such as hypothyroidism, Cushing's disease, and
hypothalamic lesions or can aggravate a number
of cardiac and respiratory diseases as well as
diabetes and hypertension."So, basically,
Medicare changed the perception of obesity from
not being a disease to being an effect or a
worsening factor of a disease. This article will
discuss the reasoning behind the change in
perception and how this change will affect
coverage in the Medicare population.
The National Health and
Nutrition Examination Survey (NHANES) from the
period 1999-2002 found that an estimated 65% of
US adults are either overweight (body
mass index [BMI] 25.0-29.9) or obese (BMI
?30). These results were dramatically greater
than those of NHANES II, during the period
1976-1980, when only 47% of US adults fell into
the category of overweight or
obese. When looking specifically at
obesity, 31% of US adults were found to be obese
during 1999-2002—an increase from 15% in
1976-1980. Two alarming factors are associated
with these statistics: the number of people and
the rate of increase.
With the increase in obesity
comes an increase in disease state complications
associated with obesity. In 2003, these
complications were estimated to produce $123
billion of all US health care costs. Because of
these dramatic costs and increased population
percentages, CMS officials have decided to make
changes that may open the door for scientific
research in this area.
What Do These Changes
Mean for Research?
The impact Medicare has on
obesity research is presented in this statement
from the policy revision: "Program payment may
not be made for treatment of obesity unrelated
to such a medical condition since treatment in
this context has not been determined to be
reasonable and necessary."The key words in this
statement are "reasonable"and "necessary." Only
research can determine whether treatment is
"necessary"to improve quality of life and reduce
complications and whether it is "reasonable" to
conserve health carerelated costs. Beneficiaries
will be able to request a review of scientific
evidence to determine whether treatments for
obesity will be covered. In the past, this
review of medical necessity would not have been
executed. It is important that the medical
sciences supply the research needed to support
these requests. Changes in Medicare coverage
depend exclusively on the scientific evidence
needed to support them.
What Do These Changes Mean
for Medicare Coverage?
In the past, Medicare and
Medicaid programs covered sickness related to or
aggravated by obesity, such as type 2 diabetes,
cardiovascular disease, several types of cancer,
and gallbladder disease. Before the revision to
the policy, weight-loss medications and obesity
treatments were not covered. Since the revision,
the deficit in coverage remains the same.
Medicare coverage has not changed, because
obesity still is not recognized as an
independent illness. Until research is presented
that will prove obesity to be an illness that
requires intensive treatment, the coverage will
remain as it is. Medicare officials will review
clinical data using the coverage-determination
procedure established in 1999 and modified by
the Medicare Prescription Drug, Improvement and
Modernization Act of 2003. CMS Chief Medical
Officer Sean Tunis, MD, has revealed that the
Medicare Coverage Advisory Committee plans to
begin discussing the evidence on obesity-related
surgical procedures that may reduce the risk of
cardiovascular and other illnesses.
When Should Changes in
Medicare Coverage of Obesity Be
Expected?
There will be no immediate
effects from the change in the CIM relating to
obesity. The process from beneficiary request to
scientific review will be a time-consuming one.
An example of the time line for change can be
seen by reviewing the request that was made for
the revision in the CIM that has been discussed
in this article. The initial request for the
revision was submitted in September 2001. The
request was reviewed throughout the next 3
years, until action finally was taken in July
2004. As this was the time line for making
changes that did not affect Medicare coverage,
one can imagine how long it will take to
implement changes that will dramatically change
the coverage policy.
How Will Changes in
Obesity Coverage Affect Pharmacy?
If Medicare policy makers
decide to cover obesity treatment in the future,
pharmacists have the ability to be great
providers in this area. Pharmacists already are
actively counseling patients on obesity in
relation to heart disease, cholesterol,
diabetes, hypertension, and other illnesses.
Pharmacists answer many questions on a daily
basis about OTC and prescription medications for
the treatment of obesity. The education and
experience of a pharmacist provide patients with
the optimal source of information regarding
diet, exercise, and medication.
Beyond the vast knowledge of
obesity treatments a pharmacist can offer, the
accessibility of a pharmacist could prove to be
the most important tool for a patient fighting
obesity. As difficult as it is to lose weight,
imagine how difficult it would be to do it alone
or without a support system to guide one through
the difficult times. A pharmacist could serve as
the patient's support system on a daily basis,
while providing the medical expertise needed to
treat obesity. What other health care
professional has the ability to provide this
day-to-day accessibility?
Medicare coverage for the
treatment of obesity will be a great opportunity
for pharmacists to be compensated for clinical
services that they may already be offering in
their practice or would like to offer if
compensation is secured. It is important for
pharmacists to be aware of the changes in
Medicare policy and to be willing to adapt their
practices to serve these needs.
Dr. Downing is a clinical
coordinator for Kerr Health Care Center,
Raleigh, NC.