September 28, 2008

Steven Phurrough, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-12-28
7500 Security Boulevard
Baltimore, MD 21244

Dear Dr. Phurrough:

Thank you for the opportunity to comment on the
Centers for Medicare and Medicaid Services’ (CMS)
Potential National Coverage Determination Topics
for the third quarter of 2008.

NOF is the nation’s leading voluntary health
organization solely dedicated to osteoporosis and
bone health. Its mission is to prevent
osteoporosis, promote lifelong bone health and
help improve the lives of those affected by
osteoporosis and related fractures and find a
cure. NOF achieves its mission through programs
of awareness, advocacy, public and health
professional education and research. NOF is a
leading authority for anyone seeking up-to-date,
medically-sound information and educational
material on the causes, prevention, detection and
treatment of osteoporosis.

Osteoporosis is a disease characterized by low
bone mass and structural deterioration of bone
tissue, leading to bone fragility and an
increased susceptibility to fractures, especially
of the hip, spine and wrist, although any bone
can be affected.

Osteoporosis is the most common bone disease in
humans. In the United States, it is a public
health threat for 44 million Americans, 55
percent of the people 50 years of age and older.
Ten million Americans are estimated to already
have the disease and almost 34 million more are
estimated to have low bone mass, placing them at
increased risk for osteoporosis. Of the ten
million Americans with osteoporosis, eight
million are women and two million are men. The
former Surgeon General states in his report on
bone health and osteoporosis, unless the US makes
a concerted effort, “in 2020 one in two Americans
over the age of 50 will have, or be at high risk
of developing, osteoporosis.

Osteoporosis often is called a “silent disease”
because bone loss occurs without symptoms.
People may not know that they have osteoporosis
until their bones become so weak that a sudden
strain, bump or fall causes a fracture or a
vertebra to collapse. Collapsed vertebrae may
initially be felt or seen in the form of severe
back pain, loss of height, or spinal deformities
such as stooped posture.

Comments

NOF believes that CMS should not proceed to a
National Coverage Determination on
bisphosphonates and vertebroplasty and
kyphoplasty since local Medicare carriers are
currently providing adequate coverage of these
services throughout the United States for
Medicare patients. NOF believes that the
decision-making process should occur between the
patient and their physician. NOF would like to
provide further information below in particular
on the two potential topics that relate to
osteoporosis: bisphosphonates and vertebroplasty
and kyphoplasty.

Bisphosphonates

To prevent fractures, which can cause long-
lasting problems that affect a person’s quality
of life, many people with osteoporosis take one
medication from the group of drugs called
bisphosphonates, which includes alendronate,
ibandronate, risedronate, and zoledronic acid.
These medicines are approved by the Food and Drug
Administration (FDA) and have proven efficacy for
reducing fracture risk. Studies report that
bisphosphonate medications reduce bone loss,
increase bone density in most people and reduce
the risk for broken bones. For example, some
studies suggest that these medications reduce the
risk of hip fracture in people with osteoporosis
by up to 40 or 50 percent.

For many patients, oral medications are not an
option, and they need to take intravenous (IV)
bisphosphonates. These include patients who
cannot sit or stand for long periods of time,
which is necessary for taking oral medications,
and patients who have gastrointestinal problems,
such as difficulty swallowing, inflammation of
the esophagus and gastric ulcer. IV
bisphosphonates can provide optimum adherence to
a regimen of bisphosphonate drug therapy.

Recently, osteonecrosis of the jaw (ONJ), a
serious and extremely rare condition which can
cause severe damage to the jawbone, has been
reported in some patients who have taken
bisphosphonates. However, ONJ has occurred
mostly in people receiving extremely high doses
of bisphosphonates through an intravenous
infusion, and 94 percent of all people with ONJ
are cancer patients receiving intravenous
bisphosphonates at higher doses than those used
to treat osteoporosis. About 6 percent of people
with ONJ have taken oral bisphosphonates to treat
osteoporosis. Cancer patients also have other
risk factors for jaw necrosis (e.g.
corticosteriod and radiation therapy). The actual
risk of getting ONJ while taking oral or IV
bisphosphonate medications to treat osteoporosis
has yet to be determined, but there is no
evidence that intravenous bisphosphonates for
treatment of osteoporosis increase the risk
compared to oral bisphosphonates. For most
patients, the benefits of receiving
bisphosphonates outweigh the potential risk of
ONJ. Patients for whom bisphosphonates are
appropriate would be at a higher risk of
fractures without any treatment and susceptible
to painful, disabling and costly fractures that
severely impact their quality of life.

Vertebroplasty and Kyphoplasty

NOF believes that there is enough evidence to
support the use of vertebroplasty and kyphoplasty
to relieve pain from vertebral fracture but that
these procedures are adjunct procedures and not a
substitute for treating the underlying
osteoporosis. The recent literature shows that
kyphoplasty does not increase the risk of
vertebral fracture when compared with nonsurgical
care. But further studies are needed in this
area. To prevent future vertebral fracture after
vertebroplasty and kyphoplasty, NOF believes that
it is vital to require that patient to take an
appropriate osteoporosis medication following
either procedure to treat the underlying cause of
the fracture. Because pain improves in most
patients in about six weeks after an acute
fracture (and the time allows for healing without
an intervention), the procedures should be
conducted on patients who do not improve during
this initial period. NOF also believes that
individuals with painful vertebral fractures that
fail conservative management may be candidates
for emerging interventions, such as kyphoplasty
or vertebroplasty, when performed by experienced
practitioners. These procedures have been shown
to be effective in patients with painful
vertebral compression fractures compared to
continued medical treatment thus significantly
improving the quality of life for patients. The
procedure also should be evaluated for patients
whose pain cannot be controlled with prescription
medication.

Conclusion

Bisphosphonate medications provide a significant
benefit to patients as many studies have shown
they can reduce bone loss, increase bone density
in most people and reduce the chance of broken
bones. For many patients, the benefits of
receiving bisphosphonates outweigh the potential
risk of ONJ since these patients would be at a
higher risk of fractures without any treatment
and susceptible to painful, disabling and costly
fractures that severely impact quality of life.
In addition, CMS must remember that many
osteoporosis patients are unable to take oral
bisphosphonates and instead must take IV
bisphosphonates because of other health
problems.

In addition, vertebroplasty and kyphoplasty have
been used widely to reduce or eliminate pain from
vertebral compression fractures for patients that
have not responded to conventional treatment.

In conclusion, NOF believes that CMS should not
proceed to a National Coverage Determination on
bisphosphonates and vertebroplasty and
kyphoplasty since local Medicare carriers are
currently providing adequate coverage of these
services throughout the United States for
Medicare patients.

Thank you again for the opportunity to comment on
the Centers for Medicare and Medicaid Services’
(CMS) Potential National Coverage Determination
Topics for the third quarter of 2008. If you
have any questions, or would like further
information, please do not hesitate to contact
NOF staff, Roberta Biegel, NOF Senior Director of
Government Relations and Public Policy, at
Roberta@nof.org or (202) 721-6364.

Sincerely,

Thomas A. Einhorn, MD
Co-chair
Advocacy Committee

C. Conrad Johnston, Jr., MD
Co-chair
Advocacy Committee

Ethel S. Siris, MD
Co-chair
Advocacy Committee

Citations:

U.S Department of Health and Human Services. Bone
Health and Osteoporosis: A Report of the Surgeon
General. Rockville, MD: U.S. Department of
Health and Human Services, Office of the Surgeon
General, 2004: 4

National Osteoporosis Foundation. Clinician’s
Guide to Prevention and Treatment of
Osteoporosis. 2008.

Woo, S, Hellstein, JW, Kalmar, JR. Systematic
Review: Bisphosphonates and Osteonecrosis of the
Jaws. Ann Intern Med. 2006; 144:753-61.

S.R. Cummings, D. Wardlaw, J. Van Meirhaeghe, L.
Bastian, J. Tillman, J. Ranstam, R. Eastell, P.
Shabe, K. Talmadge, S. Boonen. A Randomized Trial
of Balloon Kyphoplasty and Nonsurgical Care for
Acute Vertebral Fracture: Who Responds Best?
JBMR, 2008. Vol 23(Sup 1): p. S68.

National Osteoporosis Foundation. Clinician’s
Guide to Prevention and Treatment of
Osteoporosis. 2008.