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Bone Mineral Density Testing

Policy Number: MP-191

Latest Review Date: January 2021

Category: Radiology                                                              

Policy Grade:  A

 

POLICY:

Children and Adolescents

Bone mineral density testing may  be considered medically necessary for any of the following risk factors:

  • A child or adolescent patient who has been treated for cancer with agents that predispose to reduced bone mineral density, including glucocorticoids, cranial radiation, methotrexate, or hematopoietic cell transplant (HCT).  These patients may have one test that is usually done within two years post-treatment.

Females

Bone mineral density testing may be considered medically necessary for any of the following risk factors when the results of the testing will affect a treatment or regimen program:

  • Women age 65 and older, regardless of other risk factors;
  • A woman with breast cancer who becomes menopausal due to treatment of breast cancer;
  • A woman with breast cancer who is being treated with aromatase inhibitors ;
  • A patient with a recent fracture when the fracture is suspected to be associated with osteoporosis;
  • A patient with long-term corticosteroid therapy which is defined as greater than three months on the equivalent of 30 mg of cortisone or greater per day;
  • A patient on long-term (greater than one month) heparin therapy;
  • A patient on long-term (greater than three months) phenytoin therapy. This is drug therapy of the treatment of seizures;
  • A patient with known hyperparathyroidism when the test result is used to determine if the patient needs a parathyroidectomy;
  • A patient with excessive doses of thyroid replacement (for this indication the test is covered only if the patient has a subnormal TSH level while on thyroid replacement);
  • A woman with primary ovarian failure or post-ablative ovarian failure before the age of 40, who is suspected of having osteoporosis;
  • A patient with known osteoporosis or osteopenia;
  • A woman with documented estrogen deficiency and at clinical risk for osteoporosis;
  • All postmenopausal women under age 65 who have one or more additional risk factors for osteoporosis, including personal history of fracture as an adult, current fracture or history of fracture in first-degree relative, current cigarette smoking, low body weight (<127 lb.);
  • As part of the initial workup prior to the initiation of glucocorticoid therapy. The most commonly used glucocorticoids include prednisone, prednisolone, betamethasone, and dexamethasone (Decadron).

Repeat bone mineral density testing may be considered medically necessary when performed every 24 or more months.

Repeat bone mineral density testing performed more often than every 24 months in females who do not develop new risk factors is considered not medically necessary.  This also applies to patients currently being treated with medications to increase bone density. 

Repeat bone mineral density testing performed more often than every 24 months in females who develop new risk factors may be considered medically necessary.

Males

Bone mineral density testing for osteoporosis in males may be considered medically necessary for men with one of the following risk factors:

  • Age, >70;
  • Low body weight;
  • Weight loss;
  • Physical inactivity;
  • Previous osteoporotic fracture;
  • Prolonged systemic corticosteroid therapy;
  • Androgen deprivation therapy. 

 

Repeat bone mineral density testing may be considered medically necessary when performed every 24 or more months.

Repeat bone mineral density testing performed more often than every 24 months in males who do not develop new risk factors is considered not medically necessary.  This also applies to patients currently being treated with medications to increase bone density. 

Repeat bone mineral density testing performed more often that every 24 months in males who develop new risk factor may be considered medically necessary.

 

DESCRIPTION OF PROCEDURE OR SERVICE:

Bone density studies can be used to identify individuals with osteoporosis and monitor response to osteoporosis treatment, with the goal of reducing the risk of fracture. Bone density is most commonly evaluated with dual x-ray absorptiometry (DXA); other technologies are also available.

Bone Mineral Density

Risk factors for fracture include low bone mass, low bone strength, a personal history of fracture as an adult, or a history of fracture in a first-degree relative. Osteoporosis, defined as low bone mass leading to an increased risk of fragility fractures, is an extremely common disease in the elderly population due to age-related bone loss in both sexes and menopause-related bone loss in women. The World Health Organization (WHO) has diagnostic thresholds for osteoporosis based on bone mineral density (BMD) measurements compared with a T score, which is the standard deviation difference between an individual’s BMD and that of a young-adult reference population. Conditions that can cause or contribute to osteoporosis include lifestyle factors such as low intake of calcium, high intake of alcohol or cigarette smoking, and thinness. Other risk factors for osteoporosis include certain endocrine, hematologic, gastrointestinal tract and genetic disorders, hypogonadal states, and medications.

BMD can be measured using different techniques in a variety of central (i.e., hip or spine) or peripheral (i.e., wrist, finger, heel) sites. While BMD measurements are predictive of fragility fractures at all sites, central measurements of the hip and spine are the most predictive. Fractures of the hip and spine (i.e., vertebral fractures) are also considered to be the most clinically relevant. BMD is typically expressed as a T score. The utility of screening BMD measurements can be established by demonstrating that screening identifies a population at increased risk of fracture and that, by treating those at-risk individuals, the rate of fractures is reduced thereby lowering fracture-related morbidity and mortality. These potential benefits of screening should outweigh the risks of screening (radiation exposure) or false positives (initiation of unnecessary treatment).

Osteoporosis Treatment

Treatment of osteoporosis includes both lifestyle measures (e.g., increased intake of calcium and vitamin D, exercise, smoking cessation) and pharmacologic measures. Current pharmacologic options include bisphosphonates such as alendronate (i.e., Fosamax), selective estrogen receptor modulators such as raloxifene (i.e., Evista), the recombinant human parathyroid hormone teriparatide (i.e., Forteo), and calcitonin. An updated 2014 systematic review funded by the Agency for Healthcare Research and Quality found good-quality evidence that bisphosphonates, denosumab, teriparatide, and raloxifene reduce fracture risk in postmenopausal women with BMD in the osteoporotic range and/or preexisting hip or vertebral fracture.

The decision to perform bone density assessment should be based on an individual’s fracture risk profile and skeletal health assessment. In addition to age, sex, and BMD, risk factors included in the World Health Organization Fracture Risk Assessment (FRAX) Tool are:

  • Low body mass index;
  • Parental history of hip fracture;
  • Previous fragility fracture in adult life (i.e., occurring spontaneously or a fracture arising from trauma which, in a healthy individual, would not have resulted in a fracture);
  • Current smoking or alcohol three or more units per day, where a unit is equivalent to a standard glass of beer (285 mL), a single measure of spirits (30 mL), a medium-sized glass of wine (120 mL), or one measure of an aperitif (60 mL);
  • A disorder strongly associated with osteoporosis. These include rheumatoid arthritis, type I (insulin dependent) diabetes, osteogenesis imperfecta in adults, untreated long-standing hyperthyroidism, hypogonadism or premature menopause (<45 years), chronic malnutrition or malabsorption, and chronic liver disease;
  • Current exposure to oral glucocorticoids or the patient has been exposed to oral glucocorticoids for more than three months at a dose of prednisolone of 5 mg daily or more (or equivalent doses of other glucocorticoids).

Measurement Tools

Available diagnostic tools use either X-rays or ultrasound. X-ray based methods measure BMD. However, studies suggest that in addition to measuring structural aspects of the bone by assessing BMD, other mechanical features and elastic properties of the bone are also important to predict the risk of fractures. X-ray based methods cannot assess these properties and therefore use of alternative methodologies such as ultrasound densitometry and quantitative computed tomography have been explored. The most commonly used technologies are described next. The following technologies are most commonly used to measure BMD.

Dual X-ray Absorptiometry (DXA)

DXA is probably the most commonly used technique to measure BMD, because of its ease of use, low radiation exposure, and its ability to measure BMD at both the hip and spine. DXA can also be used to measure peripheral sites, such as the wrist and finger. DXA generates two x-ray beams of different energy levels to scan the region of interest and measure the difference in attenuation as the beam passes through the bone and soft tissue. The low-energy beam is preferentially attenuated by bone, while the high-energy beam is attenuated by both bone and soft tissue. This differential attenuation between the two beams allows for correction for the irregular masses of soft tissue, which surround the spine and hip, and therefore the measurement of bone density at those sites.

Quantitative Computed Tomography (QCT)

QCT depends on the differential absorption of ionizing radiation by calcified tissue and is used for central measurements only. Compared to DXA, QCT is less readily available and associated with relatively high radiation exposure and relatively high cost.

Ultrasound Densitometry

Ultrasound densitometry is a technique for measuring BMD at peripheral sites, typically the heel, but also the tibia and phalanges. Compared to osteoporotic bone, normal bone demonstrates higher attenuation of the ultrasound wave, and is associated with a greater velocity of the wave passing through bone. Ultrasound densitometry has no radiation exposure, and machines may be purchased for use in an office setting.

The above techniques dominate BMD testing. Single- and dual-photon absorptiometry and radiographic absorptiometry are now rarely used and may be considered obsolete.

Lunar iDXA is a DEXA machine that measures the bone density and also the body composition in one scan. This should be coded as a DEXA scan and subject to the same coverage criteria and limitations.

KEY POINTS:

The most recent literature review was performed through December 3, 2020. Following is a summary of key literature to date.

Summary of Evidence

Bone mineral density (BMD) studies can be used to identify individuals with osteoporosis and monitor response to osteoporosis treatment, with the goal of reducing the risk of fracture. Bone density is most commonly evaluated with dual x-ray absorptiometry (DXA); other technologies are available. For individuals who are eligible for screening of BMD based on risk factor assessment who receive DXA analysis of central sites (hip or spine), the evidence includes systematic reviews of randomized controlled trials and cohort studies. Relevant outcomes are morbid events, functional outcomes, quality of life, hospitalizations, and medication use. Central DXA is the most widely accepted method for measuring BMD and is the reference standard against which other screening tests are evaluated. BMD measurements with central DXA identify individuals at increased risk of fracture, and osteoporosis medications reduce fracture risk in the population identified as osteoporotic by central DXA. Therefore, test results with initial central DXA can be used to guide therapy. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals without osteoporosis on initial screen who receive repeat DXA analysis of  central sites (hip or spine), the evidence includes systematic reviews of large cohort and observational studies. Relevant outcomes are morbid events, functional outcomes, quality of life, hospitalizations, and medication use. Little research has been done on the frequency of BMD monitoring for osteoporosis. The available research has evaluated repeat measurement with  central DXA. Evidence on whether repeat measurements add to risk prediction compared with a single measurement is mixed. Although the optimal interval may differ depending on risk factors, current evidence does not support repeat monitoring in patients with BMD on DXA in the normal range. The evidence is insufficient to determine the effects of the technology on health outcomes. Although the evidence is limited, multiple clinical practice guidelines recommend repeat DXA in 3-5 years in patients at low risk using risk factor assessment. Similarly, multiple guidelines recommend a repeat screening interval of 1-2 years for high risk individuals and in individuals with a baseline evaluation near a fracture intervention threshold (osteopenia).

For individuals who are receiving pharmacologic treatment for osteoporosis who receive repeat  DXA analysis of central sites (hip or spine), the evidence includes systematic reviews of randomized controlled trials and observational studies. Relevant outcomes are morbid events, functional outcomes, quality of life, hospitalizations, and medication use. There is no high-quality evidence to guide how often to monitor BMD during osteoporosis treatment. Within-person variation in measurement may exceed treatment effects, and fracture risk has been shown to be reduced in some treatment studies in the absence of changes in BMD. Together, these results suggest that frequent (ie, every two years) repeat monitoring has low value. It is unclear whether DXA at the end of the initial five years of therapy is sufficiently accurate to guide subsequent therapy. The evidence is insufficient to determine the effects of the technology on health outcomes. Although the evidence is limited, multiple clinical practice guidelines recommend repeat DXA at intervals of 1-3 years to monitor treatment response in patients who are receiving pharmacological treatment for osteoporosis or after a change in or cessation of treatment.

For individuals who are eligible for screening of BMD based on risk factor assessment who receive ultrasound densitometry, or quantitative computed tomography, or DXA analysis of peripheral sites, the evidence includes observational studies and systematic reviews. Relevant outcomes are morbid events, functional outcomes, quality of life, hospitalizations, and medication use. In comparison with central DXA, other measures of bone health showed area under the curves around 0.80 for the identification of osteoporosis. These technologies are not commonly used for BMD measurements in practice, and no studies have shown that they can select patients who benefit from treatment for osteoporosis. There is little to no evidence on the usefulness of repeat measurement of BMD using these techniques. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

International Society for Clinical Densitometry

The 2019 update of the International Society for Clinical Densitometry guidelines recommend bone density testing in the following patients:

  • Women age 65 and older;
  • Postmenopausal women under age 65 with risk factors for fracture such as;
    • Low body weight
    • Prior fracture
    • High risk medication use
    • Disease or condition associated with bone loss.
  • Women during the menopausal transition with clinical risk factors for fracture, such as low bone weight, prior fracture or high-risk medication use;
  • Men age 70 and older;
  • Men under age 70 if they have risk factors for low bone mass such as;
    • Low body weight
    • Prior fracture
    • High risk medication use
    • 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;
  • Anyone being considered for pharmacologic therapy;
  • Anyone being treated, to monitor treatment effect
  • Anyone not receiving therapy in who evidence of bone loss would lead to treatment.

The 2019 position statement makes the following recommendations on serial BMD measurements:

  • Serial BMD testing in combination with clinical assessment of fracture risk, bone turnover markers, and other factors including height loss and trabecular bone score, can be used to determine whether treatment should be initiated in untreated patients, according to locally applicable guidelines.
  • Serial BMD testing can monitor response to therapy by finding an increase or stability of bone density.
  • Serial BMD testing should be used to monitor individuals following cessation of osteoporosis pharmacologic therapy.
  • Serial BMD testing can detect loss of bone density, indicating the need for assessment of treatment adherence, evaluation of secondary causes of osteoporosis, and re-evaluation of treatment options.
  • Follow-up BMD testing should be done when the results are likely to influence patient management.
  • Intervals between BMD testing should be determined according to each patients clinical status: typically one year after initiation or change of therapy is appropriate, with longer intervals once therapeutic effect is established.
  • In conditions associated with rapid bone loss, such as glucocorticoid therapy, testing more frequently is appropriate.

American Association of Clinical Endocrinologists and American College of Endocrinology

In 2020, the American Association of Clinical Endocrinologists and the American College of Endocrinology issued updated joint guidelines on the diagnosis and treatment of postmenopausal osteoporosis. The guidelines listed the potential uses for BMD measurements in postmenopausal women as:

  • "Screening for osteoporosis
  • Establishing the severity of osteoporosis or bone loss in patients with suspected osteoporosis (for example, patients withfractures or radiographic evidence of osteopenia)
  • Determining fracture risk—especially when combined with other risk factors for fractures
  • Identifying candidates for pharmacologic intervention
  • Assessing changes in bone density over time in treated and untreated patients
  • Enhancing acceptance of, and perhaps adherence with, treatment
  • Assessing skeletal consequences of diseases, conditions, or medications known to cause bone loss"

The Endocrine Society published clinical practice guidelines on osteoporosis in men. The guidelines recommend BMD testing in men at increased risk of osteoporosis, including those aged 70 or older, and younger men (ages 50-69) with pathologic conditions associated with low bone mass or increased bone loss, or those taking medications associated with bone loss. The guideline recommends the use of the Fracture Risk Assessment Tool or another fracture risk calculator to assess fracture risk and select patients for treatment.

There was no specific recommendation on repeat BMD testing in asymptomatic men. However, the supporting document notes that the least significant change approach can be used to identify significant bone loss in men who are untreated. Because the expected rate of bone loss is slower in untreated men than the expected gains during treatment, less frequent measurements (e.g., 2-3 years) in untreated men may be a more appropriate screening interval. In 2019, the Endocrine Society published clinical practice guidelines on the pharmacological management of osteoporosis in postmenopausal women. Recommendations on these guidelines were based on systematic reviews and meta-analyses, and application of the GRADE methodological framework, including quality of evidence assessments and strength of recommendation designations. When evidence was extremely limited, recommendations were based on expert review.

For women who are being treated for osteoporosis, the guidelines recommended BMD testing with central DXA every 1 to 3 years to assess response to treatment. In women who are taking bisphosphonates, the guideline authors recommended reassessment of fracture risk after 3 to 5 years (5 years for oral, 3 for IV) with clinical risk assessment and BMD testing. Women who remain at high risk of fractures should continue therapy, whereas those who are at low-to-moderate risk of fractures should be considered for a ‘bisphosphonate holiday’. Once a bisphosphonate holiday is initiated, fracture risk should be reassessed every 2 to 4 years. Clinicians should consider reinitiating osteoporosis therapy earlier than the 5-year suggested maximum if there is a significant decline in BMD, a fracture, or other factors that alter the clinical risk status. For women taking denosumab, the guideline authors recommended reassessment of fracture risk with BMD and clinical risk assessment after 5 to 10 years. Women who remain at high risk of fractures should either continue denosumab or be treated with other osteoporosis therapies.

The American Association of Clinical Endocrinologists and American College of Endocrinology published joint guidelines on the diagnosis and treatment of postmenopausal osteoporosis. For patients on osteoporosis pharmacotherapy, the guidelines recommended obtaining a baseline DXA and repeating DXA every 1 to 2 years until findings are stable. Successful treatment of osteoporosis was defined as stable or increasing BMD with no evidence of new fractures or fracture progression. The guidelines recommended continued followup every 1-2 years or at a  lessfrequent interval, depending on clinical circumstances. They also noted that followup of patients should ideally be conducted in the same facility with the same machine. 

Recommendations on length of treatment were as follows:

  • "Limit treatment with abaloparatide and teriparatide to 2 years and follow abaloparatide or teriparatide therapy with a bisphosphonate or denosumab
  • Limit treatment with romosozumab to 1 year and follow with a drug intended for long-term use, such as a bisphosphonate ordenosumab
  • For oral bisphosphonates, consider a bisphosphonate holiday after 5 years of treatment if fracture risk is no longer high (such as when the T score is greater than -2.5, or the patient has remained fracture free), but continue treatment up to an additional 5 years if fracture risk remains high
  • For oral bisphosphonates, consider a bisphosphonate holiday after 6 to 10 years of stability in patients with very high fracture risk
  • For zoledronate, consider a bisphosphonate holiday after 3 years in high-risk patients or until fracture risk is no longer high, and continue for up to 6 years in very-high risk patients
  • The ending of a bisphosphonate holiday should be based on individual patient circumstances such as an increase in fracture risk, a decrease in bone mineral density beyond the least significant change (LSC) of the dual-energy X-ray absorptiometry (DXA) machine, or an increase in bone turnover markers
  • A holiday is not recommended for non-bisphosphonate antiresorptive drugs (Grade A; BEL 1), and treatment with such agentsshould be continued for as long as clinically appropriate
  • If denosumab therapy is discontinued, patients should be transitioned to another antiresorptive"

The Endocrine Society Guidelines on Osteoporosis in Men recommended measuring BMD with central DXA every 1 to 2 years to monitor response to treatment, with less frequent monitoring once BMD appears to reach a plateau.

American College of Physicians

The guidelines from the American College of Physicians (2017) on the treatment of osteoporosis recommended against bone density monitoring during the 5-year pharmacologic treatment period of osteoporosis in women (weak recommendation, low-quality evidence). The American College of Physicians noted that data from several studies showed a reduction in fractures with pharmacologic treatment, even when BMD did not increase. In addition, current evidence “does not support frequent monitoring of women with normal bone density for osteoporosis, because data showed that most women with normal CSA scores did not progress to osteoporosis within 5 years.”

American Society for Bone and Mineral Research

2016 guidelines from an ASBMR task force included the following statement on managing osteoporosis in patients on longterm bisphosphonate treatment: "Reassessment includes clinical evaluation, risk assessment including risk factors, and may include bone density measurement by DXA. The monitoring interval with DXA should be based upon changes that are detectable and clinically significant. Reassessment may be necessary at less than 2 years in patients with a new fracture, or in light of anticipated accelerated bone loss (e.g. institution of aromatase inhibitor or glucocorticoid therapy)."

American College of Obstetricians and Gynecologists

In 2012 (reaffirmed 2016), the American College of Obstetricians and Gynecologists (ACOG) issued updated guidelines on managing osteoporosis in women. The guidelines recommend that BMD screening should begin for all women at age 65 years. In addition, they recommend screening for women younger than 65 years in whom the Fracture Risk Assessment (FRAX) Tool indicates a ten-year risk of osteoporotic fracture of at least 9.3%. Alternatively, they recommend BMD screening women in younger than 65 or with any of the following risk factors (these are similar, but not identical to risk factors in FRAX):

  • Personal medical history of a fragility fracture
  • Parental medical history of hip fracture
  • Weight less than 127 lb
  • Medical causes of bone loss (i.e., medications or disease)
  • Current smoker
  • Alcoholism
  • Rheumatoid arthritis
  • For women who begin medication treatment for osteoporosis, a repeat BMD is recommended one to two years later to assess effectiveness. If BMD is improved or stable, additional BMD testing (in the absence of new risk factors) is not recommended. The guideline notes that it generally takes 18 to 24 months to document a clinically meaningful change in BMD and thus a two-year interval after treatment initiation is preferred to one year.
  • The guidelines do not specifically discuss repeat BMD screening for women who have a normal finding on the initial test.
  • Routine BMD screening is not recommended for newly menopausal women as a “baseline” screen.

American College of Radiology

The 2017 update of appropriateness criteria from the American College of Radiology, state that BMD measurement is indicated whenever a clinical decision is likely to be directly influenced by the result of the test.  Indications for DXA include but are not limited to the following patient populations:

  • All women age 65 years and older and men age 70 years and older (asymptomatic screening).
  • Women younger than age 65 years who have additional risk for osteoporosis, based on medical history and other findings. Additional risk factors for osteoporosis include:
  1. Estrogen deficiency
  2. A history of maternal hip fracture that occurred after the age of 50 years.
  3. Low body mass (less than 127 lbs or 57.6 kg).
  4. History of amenorrhea (more than 1 year before age 42 years).
  • Women younger than age 65 years or men younger than age 70 years who have additional risk factors, including:
  1. Current use of cigarettes
  2. Loss of height, thoracic kyphosis.
  • Individuals of any age with bone mass osteopenia, or fragility fractures on imaging studies such as radiographs, computed tomography (CT, of magnetic resonance imaging [MRI])
  • Individuals age 50 years and older who develop a wrist, hip, spine, or proximal humerus fracture with minimal or no trauma, excluding pathologic fractures.
  • Individuals of any age who develop 1 or more insufficiency fractures.
  • Individuals receiving (or expected to receive) glucocorticoid therapy for more than three (3) months.
  • Individuals beginning or receiving long-term therapy with medications known to adversely affect BMD (e.g., anticonvulsant drugs, androgen deprivation therapy, aromatase inhibitor therapy, or chronic heparin.
  • Individuals with an endocrine disorder known to adversely affect BMD (e.g., hyperparathyroidism, hyperthyroidism, or Cushing’s syndrome).
  • Hypogonadal men older than 18 years and men with surgically or chemotherapeutically induced castration.
  • Women younger than age 65 years who have additional risk for osteoporosis, based on individuals with medical conditions that could alter BMD, such as:
  1. Chronic renal failure.
  2. Rheumatoid arthritis and other inflammatory arthritis.
  3. Eating disorders, including anorexia nervosa and bulimia.
  4. Organ transplantation.
  5. Prolonged immobilization.
  6. Conditions associated with secondary osteoporosis, such as gastrointestinal malabsorption or malnutrition, sprue, osteomalacia, vitamin D deficiency, acromegaly, chronic alcoholism chronic alcoholism or established cirrhosis, and multiple myeloma
  7. Individuals who have had gastric bypass for obesity. The accuracy of DXA in these patients might be affected by obesity.
  • Individuals being considered for pharmacologic therapy for osteoporosis.
  • Individuals being monitored to:

a. Assess the effectiveness of osteoporosis drug therapy.

b. Follow-up medical conditions associated with abnormal BMD.

National Osteoporosis Foundation

The National Osteoporosis Foundation (NOF) updated its practice guidelines in 2014. NOF guidelines recommend that all postmenopausal women and men age 50 and older should be evaluated clinically for osteoporosis risk to determine the need for BMD testing.

BMD assessment is indicated in:

  • Women age 65 and older and men age 70 and older, regardless of other risk factors
  • Younger postmenopausal women and men aged 50–69 with clinical risk factors for fracture
  • Adults who have a fracture after age 50
  • Adults with a condition or taking a medication associated with low bone mass or bone loss

NOF states that measurements for monitoring patients should be performed in accordance with medical necessity, expected response and in consideration of local regulatory requirements. NOF recommends that repeat BMD assessments generally agree with Medicare guidelines of every two years, but recognizes that testing more frequently may be warranted in certain clinical situations.

NOF also indicates that “Central DXA assessment of the hip or lumbar spine is the “gold standard” for serial assessment of BMD. Biological changes in bone density are small compared to the inherent error in the test itself, and interpretation of serial bone density studies depends on appreciation of the smallest change in BMD that is beyond the range of error of the test. This least significant change (LSC) varies with the specific instrument used, patient population being assessed, measurement site, technologist’s skill with patient positioning and test analysis, and the confidence intervals used. Changes in the BMD of less than three to six percent at the hip and two to four percent at the spine from test to test may be due to the precision error of the testing itself.”

North American Menopause Society

The North American Menopause Society issued a 2010 position statement, which states that fracture is the most significant risk of low bone density. The statement also concludes that BMD is an important determinant of fracture risk, especially in women 65 years and older.

U.S. Preventive Services Task Force Recommendations

The USPSTF (2018) updated its recommendations on screening for osteoporosis with bone density measurements. The USPSTF recommended screening for osteoporosis in women aged 65 years or older and in postmenopausal women younger than 65 years at increased risk of osteoporosis. The supporting document notes there are multiple instruments to predict risk for low BMD, including the Fracture Risk Assessment Tool. The updated USPSTF recommendations stated that the scientific evidence is “insufficient” to assess the balance of benefits and harms of screening for osteoporosis screening in men. The Task Force did not recommend specific screening tests but said the most commonly used tests are DXA of the hip and lumbar spine and quantitative ultrasound of the calcaneus.

The USPSTF concluded the evidence base is sparse on screening interval. While two studies showed no advantage to repeated testing, other evidence suggested that the optimal screening interval may vary by baseline BMD, age, and use of hormone replacement therapy.

KEY WORDS:

Bone mineral density testing, BMD, bone mineral density studies, bone mineral studies, Dual X-ray Absorptiometry, DXA, Dual-energy x-ray absorptiometry, DEXA, Quantitative Computed Tomography QCT, Ultrasound Densitometry, dual photon absorptiometry, radiographic absorptiometry, single photon absorptiometry, Lunar iDXA

APPROVED BY GOVERNING BODIES:

Several devices that measure bone density have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. Some examples include:

FDA Cleared Devices to Measure Bone Density

Device Name Company 510(k) number
Aria GE Medical Systems K108782
Ge Lunar Dxa Bone Densitometers With Enc GE Medical Systems K161682
Tbs Insight Medimaps Group Sa
K152299  
     
Single Energy (Se) Femur Exams Hologic, Inc. K130277
Tbs Insight Medimaps Group Sa K121716
Virtuost O.N. Diagnostics K113725
Accudxa2 Lone Oak Medical Technologies, Llc K113616
Ultrascan 650 Cyberlogic, Inc. K161919
Bindex Bi-2 Bone Index Finland, Ltd. K161971
Bindex Bi-100 Bone Index Finland, Ltd. K152020
Achilles GE Medical Systems K123238
Beammed Sunlight Miniomni Bone Sonometer Beam-Med Ltd K110646
Achilles GE Medical Systems K103633

FDA product codes: KGI, MUA.

In addition, some ultrasound bone sonometers have been approved by FDA through the premarket approval (PMA) process. One example is the Sahara® Clinical Bone Sonometer (Hologic), which received approval in March 1998. Its intended use is for quantitative ultrasound measurement of the calcaneus (heel bone), the results of which can be used in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and medical conditions leading to reduced bone density, and ultimately in the determination of fracture risk.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply.  Refer to member’s benefit plan.  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING:

CPT codes:

76977

Ultrasound bone density measurement and interpretation, peripheral site(s), any method

77078

Computed tomography, bone mineral density study, 1 or more sites; axial skeleton (e.g., hips, pelvis, spine)

77080

Dual-energy x-ray absorptiometry (DXA), bone density study, 1 or more sites; axial skeleton (e.g., hips, pelvis, spine)

77081

Dual-energy x-ray absorptiometry (DXA), bone density study, 1 or more sites; appendicular skeleton (peripheral) (e.g., radius, wrist, heel)

0508T

Pulse-echo ultrasound bone density measurement resulting in indicator of axial bone mineral density, tibia (Effective 07/01/2018)

78350

Bone density (bone mineral content) study, 1 or more sites; single photon absorptiometry

78351

Bone density (bone mineral content) study, 1 or more sites; dual photon absorptiometry

 

HCPCS code:

G0130

Single energy x-ray absorptiometry (SEXA) bone density study, one or more sites; appendicular skeleton peripheral) (e.g., radius, wrist, heel)

REFERENCES:

  1. ACR Appropriateness Criteria™. Osteoporosis and bone mineral density.: //acsearch.acr.org/TopicList.aspx.
  2. ACR Appropriateness Criteria™. Osteoporosis and bone mineral density. //www.guideline.gov/content.aspx?id=23824&search=osteoporosis.
  3. Adams AL, Fischer H, Kopperdahl DL, et al. Osteoporosis and Hip Fracture Risk From Routine Computed Tomography Scans: The Fracture, Osteoporosis, and CT Utilization Study (FOCUS). J Bone Miner Res. Jul 2018;33(7):1291-1301.
  4.  Adler RA, El-Hajj Fuleihan G, Bauer DC, et al. Managing Osteoporosis in Patients on Long-Term Bisphosphonate Treatment:Report of a Task Force of the American Society for Bone and Mineral Research. J Bone Miner Res. Oct 2016; 31(10): 1910.
  5. Agency for Healthcare Research and Quality. Treatment To Prevent Fractures in Men and Women With Low Bone Density or Osteoporosis: Update of a 2007 Report. 2012; https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/osteoporosis-bone-fracture_research.pdf. Accessed November 18, 2018.
  6. American Association of Clinical Endocrinologists A. Medical Guidelines for Clinical Practice for the Diagnosis and Treatment of Postmenopausal Osteoporosis. Endocr. Pract. 2010; 16 Suppl 3: 1-37.
  7. American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins. Osteoporosis (Practice Bulletin N. 129). Obstet Gynecol 2012; 120(3):718-734.
  8. American College of Radiology (ACR). ACR Practice Guideline for the performance of adult dual or single x-ray absorptiometry (DXA/pDXA/SXA). https://www.acr.org/~/media/EB34DA2F786D4F8E96A70B75EE035992.pdf.
  9. Baim S, Leonard MB, Bianchi ML et al. Official positions of the International Society for Clinical Densitometry and executive summary of the 2007 ISCD Pediatric Position Development Conference. J Clin Densitom 2008; 11 (1): 6-21.
  10. Bauer DC, Schwartz A, Palermo L, et al. Fracture prediction after discontinuation of 4 to 5 years of alendronate therapy: the FLEX study. JAMA Intern Med. Jul 2014; 174(7):1126-1134.
  11. Bell KJ, Hayen A, Macaskill P, et al. Value of routine monitoring of bone mineral density after starting bisphosphonate treatment: Secondary analysis of trial data. BMJ, June 2009; 338: b2266.
  12. Berger C, Langsetmo L, Joseph L, et al. Change in bone mineral density as a function of age in women and men and association with the use of antiresorptive agents. CMAJ. 2008; 178(13):1660-1668.
  13. Berry SD, Samelson EJ, Pencina MJ et al. Repeat bone mineral density screening and prediction of hip and major osteoporotic fracture. JAMA 2013; 310 (12): 1256-1262.
  14. Black DM, Schwartz AV, Ensrud KE, et al. Effects of continuing or stopping alendronate after 5 years of treatment: the Fracture Intervention Trial Long-term Extension (FLEX): a randomized trial. JAMA. Dec 27 2006; 296(24):2927-2938.
  15. Blue Cross Blue Shield Association. Technology Evaluation Center (TEC) Assessment 1999; Volume 14: Tab 19.
  16. Blue Cross Blue Shield Association. Technology Evaluation Center (TEC) Assessment 2002; Volume 17: Tab 5.
  17. Blue Cross Blue Shield Association. Technology Evaluation Center (TEC) Assessment 1999; Tab 24.
  18. Carrasco F, Ruz M, Rojas P, Csendes A, et al. Changes in bone mineral density, body composition and adiponectin levels in morbidly obese patients after bariatric surgery. Obes Surg, January 2009; 19(1): 41-46.
  19. Camacho PM, Petak SM, Binkley N, et al. American Association of Clinical Endocrinologists and American College of Endocrinology Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis - 2016. Endocr Pract. Sep 02 2016; 22(Suppl 4):1-42.
  20. Cauley JA, Cawthon PM, Peters KE, et al. Risk factors for hip fracture in older men: The Osteoporotic Fractures in Men Study (MrOS). J Bone Miner Res. Oct 2016; 31(10):1810-1819.
  21. Crandall CJ, Hovey KM, Andrews CA, et al. Bone mineral density as a predictor of subsequent wrist fractures: findings from the Women's Health Initiative Study. J Clin Endocrinol Metab. Nov 2015; 100(11):4315-4324.
  22. Crandall CJ, Newberry SJ, Diamant A, et al. Comparative effectiveness of pharmacologic treatments to prevent fractures: an updated systematic review. Ann Intern Med. Nov 18 2014; 161(10):711-723.
  23. Cummings SR, Palermo L, Browner W et al. Monitoring osteoporosis therapy with bone densitometry: misleading changes and regression to the mean. Fracture Intervention Trial Research Group. JAMA 2000; 8; 283(10):1318-1321.
  24. Cure Search Children’s Oncology Group. Long-term follow-up guidelines for survivors of childhood, adolescent, and young adult cancers. Version 3.0 – October 2008. www.survivorshipguidelines.org.
  25. Dawson-Hughes B, Lindsay R, Khosla S, et al. Clinician’s guide to prevention and treatment of osteoporosis 2008s. National Osteoporosis Foundation.  www.nof.org.
  26. Dawson-Hughes B, Tosteson ANA, Melton III, LJ, et al. Implications of absolute fracture risk assessment for osteoporosis practice guidelines in the USA. Osteoporosis Int 2008.
  27. Eastell R, Rosen CJ, Black DM et al. Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society* Clinical Practice Guideline.. J. Clin. Endocrinol. Metab., 2019 Mar 26;104(5).
  28. Expert Panel on Musculoskeletal I, Ward RJ, Roberts CC, et al. ACR Appropriateness Criteria((R)) Osteoporosis and Bone Mineral Density. J Am Coll Radiol. May 2017;14(5S): S189-S202.
  29. Faulkner KG, McClung MR, Ravin DJ et al. Monitoring skeletal response to therapy in early post-menopausal women: which bone to measure? J Bone Miner Res 1996; 11(suppl 1):S96.
  30. Federal Register, Wednesday, June 24, 1998, volume 63, no. 121 pp. 34320-34328.
  31. Fleischer J, Stein EM, Bessler M, et al. The decline in hip bone density after gastric bypass surgery is associated with extent of weight loss. J Clin Endosrinol Metab, October 2008; 93(10): 3735-3740.
  32. Frost SA, Nguyen ND, Center JR, et al. Timing of repeat BMD measurements:  Development of an absolute risk-based prognostic model. J Bone Miner Res, November 2009; 24(11): 1800-1807.
  33. Gadam RK, Schlauch K, Izuora KE. Frax prediction without BMD for assessment of osteoporotic fracture risk. Endocr Pract 2013; 19 (5): 780-784.
  34. Gourlay ML, Ensrud KE. Bone density and bone turnover marker monitoring after discontinuation of alendronate therapy: an evidence-based decision to do less. JAMA Intern Med. Jul 2014; 174(7):1134-1135.
  35. Gourlay ML, Fine JP, Preisser JS et al. Bone-density testing interval and transition to osteoporosis in older women. N Engl J Med 2012; 366(3):225-233.
  36. Gourlay ML, Preisser JS, Lui LY et al. BMD screening in older women: initial measurement and testing interval. J Bone Miner Res 2012; 27(4):743-746.
  37. Hillier TA, Stone KL, Bauer DC et al. Evaluating the value of repeat bone mineral density measurement and prediction of fractures in older women: the study of osteoporotic fractures. Arch Intern Med 2007; 167(2):155-160.
  38. Hodgson SF, Watts NB, et al. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the Prevention and Treatment of Postmenopausal Osteoporosis: 2001 Edition, with Selected Updates for 2003. Endocrine Practice, Nov/Dec 2003, Vol. 9, No. 6.
  39. International Society for Clinical Densitometry. 2013 ISCD Official Positions-Adult 2013; //www.iscd.org/official-positions/2013-iscd-official-positions-adult/.
  40. Johnell O, Kanis JA, Oden A, et al. Predictive value of BMD for hip and other fractures. J Bone Miner Res. 2005; 20(7):1185-1194.
  41. Leslie WD, Brennan-Olsen SL, Morin SN, et al. Fracture prediction from repeat BMD measurements in clinical practice. Osteoporos Int. Jan 2016; 27(1):203-210.
  42. Lewiecki EM, Compston JE, Miller PD, et al. Official positions for FRAX® Bone Mineral Density and FRAX® simplification from Joint Official Positions Development Conference of the International Society for Clinical Densitometry and International Osteoporosis Foundation on FRAX®. J Clin Densitom. 2011; 14(3):226-236.
  43. Liu H, Paige NM, Goldzweig CL, et al. Screening for osteoporosis in men: a systematic review for an American College of Physicians Guideline. Ann Intern Med 2008; 148: 685-701.
  44. Mincy BA. Osteoporosis in women with breast cancer, Current Oncology Reports, January 2003; 5: 53-57.
  45. National Institutes of Health Consensus Development Conference Consensus Statement.  Osteoporosis, prevention, diagnosis, and therapy. 2001; 17(1).
  46. National Osteoporosis Foundation. Clinician’s guide to prevention and treatment of osteoporosis. 2010. //www.nof.org/sites/default/files/pdfs/NOF_ClinicianGuide2009_v7.pdf.
  47. National Osteoporosis Foundation. Osteoporosis: Review of the Evidence for prevention, diagnosis and treatment and cost-effectiveness analysis. Osteoporosis Int 1998; 8(suppl 4): 1-88.
  48. Neff, MJ. Practice guidelines: ACOG releases guidelines for clinical management of osteoporosis. American Family Physician. 2004; 69(6).
  49. Nelson HD, Haney EM, Chou R, et al. Screening for Osteoporosis: Systematic Review to Update the 2002 U.S. Preventive Services Task Force Recommendation (Evidence Synthesis No. 77; AHRQ Publication No. 10-05145-EF-1).
  50. North American Menopause Society. Position Statement: Management of Osteoporosis in Postmenopausal Women. Menopause 2010: 17(1): 25-54. 2010.
  51. Oregon Evidence-based Practice Center prepared to Agency for Healthcare Research and Quality (AHRQ). Screening for Osteoporosis: Systematic Review to Update the 2002 U.S. Preventive Services Task Force Recommendation. Available online at: www.ncbi.nlm.nih.gov/books/NBK45201/pdf/TOC.pdf.
  52. Osteoporosis. Goldman: Cecil Textbook of Medicine, 21st ed., Copyright © 2000. W. B. Saunders Company.
  53. Osteoporosis.  Stenchever: comprehensive Gynecology, 4th ed., Copyright © 2001 Mosby, Inc.
  54. Physician’s Guide to Prevention and Treatment of Osteoporosis. National Osteoporosis Foundation, 1150 17th Street, NW, Suite 500, Washington, DC. (In addition, the guide may be accessed via the Internet at www.nof.org.)
  55. Qaseem A, Forciea MA, McLean RM, Denberg TD, Clinical Guidelines Committee of the American College of P. Treatment of Low Bone Density or Osteoporosis to Prevent Fractures in Men and Women: A Clinical Practice Guideline Update From the American College of Physicians. Ann Intern Med. Jun 6 2017;166(11):818-839. 
  56. Quaseem A, Snow V, Shekelle P, et al. Screening for osteoporosis in men: a clinical practice guideline from the American College of Physicians. Ann Intern Med 2008; 148: 680-684.
  57. Ramaswamy B and Shapiro CL. Osteopenia and osteoporosis in women with breast cancer, Seminars in Oncology, December 2003; 30(6): 763-775.
  58. Ravdin PM. Managing the risk of osteoporosis in women with a history of early breast cancer, October 2004; 18(11): 1385-1390; 1393.
  59. Rose SR. Bone problems in childhood cancer patients. www.uptodate.com.
  60. Schousboe JT, Shepherd JA, Bilezikian JP, et al. Executive summary of the 2013 International Society for Clinical DensitometryPosition Development Conference on bone densitometry. J Clin Densitom. Oct-Dec 2013; 16(4): 455-66.
  61. Smith MR. Therapy insight: osteoporosis during hormone therapy for prostate cancer.  Nature Clinical Practice Urology. 2005; 2(12):608-615.
  62. South-Paul JE. Osteoporosis: Part I.  Evaluation and assessment. American Family Physician. 2001; 63(5).
  63. U.S. Department of Health & Human Services. Bone Health and Osteoporosis: A Report of the Surgeon General. Office of the Surgeon General 2004.
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  70. Wasilewski-Masker K, Kaste SC, Hudson MM, et al. Bone mineral density deficits in survivors of childhood cancer: long-term follow-up guidelines and review of the literature. Pediatrics 2008; 121(3):e705-e713.
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POLICY HISTORY:

Medical Policy Group, March 1998

Medical Policy Group, January 2000

Medical Policy Administration Committee, July 2004

Medical Policy Group, August 2004 (2)

Medical Policy Administration Committee, September 2004

Available for comment September 8-October 22, 2004

Medical Policy Group, March 2005 (3)

Medical Policy Administration Committee May 2005

Available for comment May 9-June 22, 2005

Medical Policy Group, April 2006

Medical Policy Group, September 2007 (1)

Medical Policy Administration Committee, October 2007

Medical Policy Group, July 2008 (2)

Medical Policy Administration Committee, August 2008

Available for comment August 13-September 26, 2008

Medical Policy Group, July 2010 (1)

Medical Policy Group, April 2011:  Updated Policy (Children & Adolescents), Key Points and References

Medical Policy Administration Committee May 2011

Available for comment May 11 – June 27, 2011

Medical Policy Group, January 2012 (3): 2012 Code Updates deleted 77079 & 77083

Medical Policy Group, February 2012 (1): Update to Key Points and References related to MPP update; no change in policy statement;

Medical Policy Group, December 2012 (3):

Available for comment December 28, 2012 through February 11, 2013

Medical Policy Panel, March 2013

Medical Policy Group, April 2013 (3): 2013 Updates to Key Points and References; no change in policy statement

Medical Policy Panel, March 2014

Medical Policy Group, January 2015(4):  Removed Policy section with Effective dates of service on or after February 1, 2012 and prior to February 12, 2013.  No other policy change.  Updates to Key Points and References

Medical Policy Panel, March 2015

Medical Policy Group, March 2015 (4):  Updates to Key Points and References. No change in policy statement.

Medical Policy Panel, September 2015

Medical Policy Group, October 2015 (2): Updates to Description, Key Points, Current Coding, and References; no change in policy statement.

Medical Policy Panel, March 2017

Medical Policy Group, April 2017 (7): 2017 Updates to Description, Key Points, Approved by Governing Bodies, and References; deleted Previous Coding section. No change in policy statement.

Medical Policy Group, June 2018: Quarterly Coding Update, July 2018.  Added new CPT code 0508T to Current Coding.

Medical Policy Panel, December 2018

Medical Policy Group, January 2019 (7): Updates to Description, Key Points, and References. No change in policy statement.

Medical Policy Panel, January 2020

Medical Policy Group, January 2020 (7): Updates to Key Points and References. No change in policy statement.

Medical Policy Panel, January 2021

Medical Policy Group, January 2021 (7): Updates to Key Points, Approved by Governing Bodies, and References. No change in policy statement.

 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

 

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

  1. The technology must have final approval from the appropriate government regulatory bodies;
  2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
  3. The technology must improve the net health outcome;
  4. The technology must be as beneficial as any established alternatives;
  5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

  1. In accordance with generally accepted standards of medical practice; and
  2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
  3. Not primarily for the convenience of the patient, physician or other health care provider; and
  4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.