1 Clinical Policy Title: Bone mineral density measurement Clinical Policy Number: 17.01.01 Effective Date: September 1, 2013 Initial Review Date: April 23, 2013 Most Recent Review Date: April 3, 2018 Next Review Date: April 2019 Related policies: CP# 00.02.05 Agents for osteoporosis ABOUT THIS POLICY: AmeriHealth Caritas has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas’ clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of “medically necessary,” and the specific facts of the particular situation are considered by AmeriHealth Caritas when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas’ clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas’ clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas will update its clinical policies as necessary. AmeriHealth Caritas’ clinical policies are not guarantees of payment. Coverage policy AmeriHealth Caritas considers the use of bone mineral density (BMD) measurement using dual-energy X-ray absorptiometry (DXA/DEXA) to be clinically proven and, therefore, medically necessary for members when at least one of the following clinical criteria and one of the following equipment criteria are met (Schweiger 2016, International Society for Clinical Densitometry [ISCD] 2013 and 2015, Blain 2014, U.S. Preventive Services Task Force [USPSTF] 2011, Qaseem 2008): Adults (ISCD 2015) Women age 65 and older. For post-menopausal women younger than age 65 a bone density test is indicated if they have a risk factor for low bone mass such as; o Low body weight o Prior fracture o High risk medication use Policy contains: Osteoporosis Bone mineral density measurement Dual-energy X-ray absorptiometry Osteoporosis
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Clinical Policy Title: Bone mineral density measurement
Clinical Policy Number: 17.01.01
Effective Date: September 1, 2013
Initial Review Date: April 23, 2013
Most Recent Review Date: April 3, 2018
Next Review Date: April 2019
Related policies:
CP# 00.02.05 Agents for osteoporosis
ABOUT THIS POLICY: AmeriHealth Caritas has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas’ clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of “medically necessary,” and the specific facts of the particular situation are considered by AmeriHealth Caritas when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas’ clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas’ clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas will update its clinical policies as necessary. AmeriHealth Caritas’ clinical policies are not guarantees of payment.
Coverage policy
AmeriHealth Caritas considers the use of bone mineral density (BMD) measurement using dual-energy
X-ray absorptiometry (DXA/DEXA) to be clinically proven and, therefore, medically necessary for
members when at least one of the following clinical criteria and one of the following equipment criteria
are met (Schweiger 2016, International Society for Clinical Densitometry [ISCD] 2013 and 2015, Blain
2014, U.S. Preventive Services Task Force [USPSTF] 2011, Qaseem 2008):
Adults (ISCD 2015)
Women age 65 and older.
For post-menopausal women younger than age 65 a bone density test is indicated if they have a
risk factor for low bone mass such as;
o Low body weight
o Prior fracture
o High risk medication use
Policy contains:
Osteoporosis
Bone mineral density
measurement
Dual-energy X-ray
absorptiometry
Osteoporosis
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o Disease or condition associated with bone loss
Women during the menopausal transition with clinical risk factors for fracture, such as low body
weight, prior fracture, or high-risk medication use.
Men age 70 and older.
For men < 70 years of age a bone density test is indicated if they have a risk factor for low bone
mass such as;
o ◦Low body weight
o ◦Prior fracture
o ◦High risk medication use
o ◦Disease or condition associated with bone loss.
Adults with a fragility fracture.
Adults with a disease or condition associated with low bone mass or bone loss.
Adults taking medications associated with low bone mass or bone loss.
Anyone being considered for pharmacologic therapy.
Anyone being treated, to monitor treatment effect.
Anyone not receiving therapy in whom evidence of bone loss would lead to treatment.
Women discontinuing estrogen should be considered for bone density testing according to the
indications listed above.
Children and adolescents (ISCD 2013)
Children or adolescents with a finding of one or more vertebral compression fractures in the
absence of local disease or high-energy trauma.
Presence of both a clinically significant fracture history and BMD Z-score ≤ -2.0.
o A clinically significant fracture history is one or more of the following:
Two or more long bone fractures by age 10 years
Three or more long bone fractures at any age up to age 19 years.
The DXA measurement is part of a comprehensive skeletal health assessment
The DXA is performed when the DXA results will influence patient treatment interventions to
decrease their elevated risk of a clinically significant fracture.
Intervals between BMD testing should be determined according to each patient’s clinical status,
typically after initiation or change of therapy. (ISCD 2015).
In certain circumstances AmeriHealth Caritas considers BMD testing to be clinically proven and
therefore medically necessary, at a frequency more than once every 23 months, when at least 11
months have elapsed since the previous BMD measurement and testing is limited to the following:
An individual currently receiving pharmaceutical management with a glucocorticoid (steroid)
equivalent to an average of 5.0 mg of prednisone or greater per day for more than three
3
months.
Confirming baseline BMDs to permit monitoring of members when the initial BMD was not done
on the axial skeleton using a DXA/DEXA system. An individual being monitored to assess the
response to, or efficacy of, a U.S. Food and Drug Administration (FDA)-approved osteoporosis
drug therapy when performed with a DXA/DEXA system (axial skeleton) until, over time, a
response to such therapy has been documented.
AND
An AmeriHealth Caritas-approved and FDA-approved densitometer is used when the results of
the BMD study will be used in treatment decisions.
A peripheral BMD may be considered to be proven and medically necessary when an FDA-
approved densitometer is used for either of the following:
o An individual physically unable to undergo axial skeleton (hip/spine) measurements due
to physical size and surpassing the table limits for the DXA/DEXA device.
o Individuals diagnosed with hyperparathyroidism for whom a BMD of the forearm is
crucial to diagnosis.
All other uses of BMD testing not described within the context of this policy are considered to be
investigational and therefore not medically necessary, as their effectiveness is not supported by peer-
reviewed professional literature.
Limitations:
AmeriHealth Caritas considers the following to be limitations to this policy:
DXA/DEXA should not be performed if contractures prevent the safe and appropriate
positioning of the individual, especially in pediatric cases (ISCD 2013).
BMD measurement must include physician interpretation.
BMD testing should be performed at DXA/DEXA facilities using accepted quality assurance
measures.
AmeriHealth Caritas considers the following BMD tests to be investigational and therefore not medically
necessary, as the use of these tests is not supported by peer-reviewed professional literature:
Single-photon absorptiometry (CT code 78350).
Dual-photon absorptiometry (CPT 78351).
All other uses of BMD measurement are not medically necessary.
Alternative covered services:
Routine patient evaluation and management by a network healthcare provider
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Background
Bone strength is an important factor in an individual’s overall mobility and resistance to fractures and is
determined in part by bone density. Bone strength and density are determined by the mineral content
of a specified area as applied to size and shape (mass) of a bone. Low-density bones are less healthy,
more fragile, and prone to fractures. Osteoporosis is a disease marked by the progressive decrease in
bone density, increased fragility, and a susceptibility to bone fractures. Osteoporosis-related changes
occur when bone loss exceeds bone formation. Osteoporotic changes in the bones are commonly found
in postmenopausal women; however, they are seen in both genders and all people of advancing age.
Secondary osteoporosis may be caused by conditions that impair the intake and utilization of nutrients,
such as anorexia nervosa, bariatric surgery, or prolonged steroid drug treatment.
BMD tests are noninvasive, used to identify individuals with osteoporosis, and may be used to monitor
response to osteoporosis treatments. The goal of detecting a low BMD in an individual is to assist with
the decision-making toward treatment to prevent a fragility (osteoporotic) fracture. The risk-predicting
ability of BMD studies has been compared to the use of cholesterol testing to predict hypertension and
heart disease. BMD studies are radiologic or radioisotopic and are performed with an FDA-approved
bone densitometer (other than single-photon or dual-photon absorptiometry) or a bone sonometer
system. The gold standard and most widely used method for BMD is DXA/DEXA.
DEXA requires a short scan time and is used to provide extremely precise and reproducible BMD
measurement. The preferred DEXA measurement sites are located on the central skeleton; these are the
total hip, femoral neck, total lumbar spine, or some combination of these sites. Central skeletal sites are
preferred for baseline and serial BMD measurements and are also more likely than peripheral skeletal
sites to show a response to treatment. Examples of peripheral skeletal sites are the wrist, finger,
forearm, or heel. Peripheral testing only uses one site, and this may be problematic because of
differences in bone density between different skeletal sites. Low bone densities in other skeletal areas
may be overlooked. It is important to note that the diagnostic criteria established by the WHO and
recommendations by the American Association of Clinical Endocrinologists (AACE) apply only to the
peripheral radius site and central (total hip, femoral neck, lumbar spine) site DEXA measurements
(AACE, 2010).
Other BMD techniques use both the central and skeletal sites. In addition to DEXA, the established