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Medicare Decides Obesity Stomach Surgery too Risky
for Senior Citizens
Nov. 23, 2005 - Medicare proposes dropping coverage
of baratric surgery for senior citizens age 65 and older in light of
recent studies indicating significant surgical risks particularly in
seniors who have used the stomach surgery paid for by Medicare to treat obesity. The Centers
for Medicare & Medicaid Services (CMS) announced today its proposal to
modify Medicare coverage of bariatric surgery to help reduce significant
health risks associated with obesity that may increase morbidity and
mortality among the Medicare population, but they still will cover those
under 65.
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Following what they say was an extensive evidence
review, CMS is still proposing national coverage for Medicare
beneficiaries under age 65 for open and laparoscopic Roux-en-Y gastric
bypass and laparoscopic adjustable gastric banding "under certain
clinical circumstances and when performed in a facility meeting
evidence-based standards for bariatric surgery."
CMS says the decision to not cover senior citizens
is based in part on recent evidence on bariatric surgery in seniors that
shows elevated risks.
In particular, CMS cited a recent study by David R.
Flum, Early Mortality Among Medicare Beneficiaries Undergoing Bariatric
Surgical Procedures [JAMA. 2005; 294:1903-1908], reported that patients
65 and older had two-to three-fold higher death rates after bariatric
surgery compared with younger persons.
Flum also reported higher death rates among persons
over age 75 and among persons whose surgeon had less past experience
with the operation.
CMS said it seeks comments on whether and how
Medicare may cover these services for Medicare beneficiaries aged 65 and
over, and support the development of better evidence of the safety and
effectiveness of the surgery for Medicare beneficiaries.
“This proposed limited coverage for bariatric
surgery is part of Medicare’s ongoing commitment to ensure access to the
most effective treatment alternatives for its beneficiaries, using the
best and latest evidence,” said CMS Administrator Mark B. McClellan,
M.D., Ph.D.
In the United States, more than 60 percent of the
population is now classified as overweight or obese. Overweight and
obese persons have an increased risk of a number of serious diseases
compared to normal weight and waist circumference.
Some of the most important, common, and costly
co-morbidities include hypertension, dyslipidemia, type 2 diabetes,
coronary heart disease, stroke, gallbladder disease, osteoarthritis,
sleep apnea, respiratory problems, and endometrial, breast, prostate,
and colon cancers.
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"Though diet and exercise are the mainstay of
treatment, bariatric surgery may be a helpful treatment option for
people with extreme obesity whose treatments have been unsuccessful and
who have developed health problems from the obesity," CMS said in the
news release.
CMS is seeking comment on this evidence and its
implications for coverage, and for the range of non-elderly patients who
would be covered.
“While the best proven ‘treatment’ is a nutritious
diet and regular exercise, and medical treatments are also available,
some beneficiaries may significantly reduce their health risks through
surgery,” Dr. McClellan said. “We are seeking public comment on the best
way to provide coverage for this surgery, to reduce the complications of
obesity while limiting the risks of the surgical treatments.”
For the proposed coverage decision, CMS found that
the evidence appears adequate to conclude that open and
laparoscopicRoux-en-Y gastric bypass and laparoscopic adjustable gastric
banding produce net health benefits in Medicare beneficiaries under age
65, who have at least one obesity-related health problem and have been
previously unsuccessful with medical treatment for their obesity. CMS
is seeking comment on this evidence and its implications for coverage,
and for the range of non-elderly patients who would be covered.
While CMS is not proposing to cover surgery in
older beneficiaries, CMS is seeking comment on expanding national
coverage of bariatric surgery in the context of clinical trials. This
policy approach would be a form of coverage with evidence development
(CED). CMS is specifically asking for public comment on coverage of
bariatric surgery under CED as well as the proposed decision itself.
CMS is also proposing facility criteria, including
a credentialing program for surgeons, a review of staff and consultant
qualifications, an integrated program for patient care, written
procedures for patient consent and adverse event reporting, and
appropriate equipment for patient care. CMS is also seeking comment on
whether we should expand the facility criteria to also include specific
bariatric surgery volume criteria for surgeons and/or facilities.
In addition to today’s proposed decision, Medicare
has taken other steps to help beneficiaries who are overweight or obese
reduce the health risks by addressing obesity. For example,
beneficiaries also can benefit from the new “Welcome to Medicare” exam.
This new benefit can be used to screen Medicare beneficiaries for many
illnesses and conditions.
Obesity also has a significant impact on Medicare
beneficiaries’ quality of life, according to the agency. By providing
an initial physician examination for all newly enrolled Medicare
beneficiaries, seniors and disabled Americans will have the opportunity
to discuss with their physician the importance of preventive care and
living a healthy lifestyle.
CMS also covers services other than bariatric
surgery that treat complications of obesity.
The proposed decision memorandum, published today,
is available on CMS’ Coverage website at
http://www.cms.hhs.gov/coverage. CMS encourages the public to
respond to the Agency’s proposed decision by submitting public comments
directly to the Coverage web site. Comments will be accepted for 30
days following the posting of the proposed decision memorandum. After
careful consideration of the public comments, CMS will issue a final
decision memorandum.
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