Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Bone Mineral Density (BMD) Testing

Policy #:09.00.04k



The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

MEDICALLY NECESSARY

Bone mineral density (BMD) testing is considered medically necessary and, therefore, covered when the individual meets one of the following criteria:
  • Females 65 years of age and older, regardless of personal or familial risk factors
  • Males 70 years of age and older, regardless of personal or familial risk factors
  • Postmenopausal females younger than 65 years of age with one of the following risk factors:
    • Caucasian or Asian (nonblack) race
    • Late menarche and early menopause
    • Discontinuing estrogen therapy
  • Postmenopausal females younger than 65 years of age and males 50-69 years of age who have at least one personal or familial risk factor that includes but is not limited to the following:
    • Low weight and/or body mass index (BMI) (body weight of less than 127 pounds or BMI of less than 21 kg per m2)
    • Family history of osteoporosis or fracture in a first-degree relative
    • Personal history of prior low-trauma or vertebral fracture
    • Increased likelihood of falls
    • Current cigarette smoking
    • Low levels of physical activity
    • Excessive alcohol intake
    • Poor nutrition with low calcium or vitamin D intake
    • Hemochromatosis
    • Hypophosphatasia
    • Thalassemia
    • Multiple myeloma
    • Taking medications that cause hypogonadism
    • Thyrotoxicosis
    • Homocystinuria
    • 10-year major osteoporosis-related fracture probability ≥ 9.3% based on the US-adapted WHO absolute fracture risk model
    • Loss of height (e.g., thoracic kyphosis)
  • Females going through menopause if there is a risk factor associated with increased fracture risk such as low body weight, prior low-trauma fracture, or high-risk medication
  • Females with exercise-induced amenorrhea or oligomenorrhea
  • Individuals of any age with any of the following risk factors:
    • Personal history of bariatric surgery
    • A condition strongly associated with osteoporosis, including, but not limited to the following:
      • Primary hyperparathyroidism
      • Type 1 insulin-dependent diabetes
      • Untreated long-standing hyperthyroidism, hypogonadism, or premature menopause (younger than 45 years), chronic malnutrition or malabsorption, and chronic liver disease
      • Cystic fibrosis
      • Osteogenesis imperfecta
      • Rheumatoid arthritis
      • Women with Turner syndrome
    • Currently taking or anticipate taking a medication associated with the development of low bone mass or bone loss (e.g., glucocorticoid, equivalent to prednisone, at least 5 mg per day, or greater, for more than three months) or with a condition associated with the development of low bone mass or bone loss (e.g., anorexia nervosa). Note: In addition to glucocorticoids, medications associated with low bone mass or bone loss include some anti-seizure medications and aromatase inhibitors (e.g., anastrazole).
    • Vertebral abnormalities as demonstrated by an x-ray to be indicative of osteoporosis, osteopenia, or vertebral fracture
  • Individuals who have a low-trauma or no-trauma fracture after 50 years of age
  • Any individual being treated for osteoporosis, to monitor treatment effect

PERIPHERAL MEASUREMENT BMD TESTING
Peripheral measurement of BMD testing is considered medically necessary and, therefore, covered for one of the following indications:
  • The hip/spine or hip/hip BMD cannot be performed (e.g., the individual is over the table limit for weight)
  • The individual has been diagnosed with hyperparathyroidism, when a BMD of the forearm is essential for diagnosis

FOLLOW-UP BMD TESTING
Follow-up BMD tests are considered not medically necessary and, therefore, not covered more than once every two years except when the results will impact the treatment decision for the individual. Follow-up BMD testing may be indicated in circumstances that include, but are not limited to, the following:
  • Monitoring individuals on long-term glucocorticoid therapy (e.g., taking at least 5 mg/day for at least three months)
  • Confirming baseline bone mass measurements to permit monitoring of individuals in the future only when a dual-energy X-ray absorptiometry (DXA/DEXA) system (axial skeleton) was not used for the initial measurement

The necessity of follow-up BMD testing at intervals of less than one year cannot be relied upon for treatment decisions when considering that the margin of error of the test is typically greater than the interval treatment effect on BMD. Test to test variability, even with the use of the same testing device, should be taken into account when addressing the expected effects of treatment.

NOT MEDICALLY NECESSARY

Single photon absorptiometry (Current Procedural Terminology [CPT] code 78350) and dual photon absorptiometry (CPT code 78351) are considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support their use in the diagnosis or treatment of illness or injury.

Performing both a peripheral and an axial BMD test on the same day is considered not medically necessary and, therefore, not covered.

EXPERIMENTAL/INVESTIGATIONAL

Pulse-echo ultrasound bone density measurement is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

Finite element analysis, (e.g., VirtuOst test), is considered experimental/investigational and, therefore, not covered for all indications, including but not limited to evaluation of fracture risk, diagnosis of osteoporosis, guidance to initiate therapy for osteoporosis, and monitoring of therapy because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to, records from the professional provider's office, hospital, nursing home, home health agency, other health care professionals, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation must be made available to the Company upon request.
Guidelines

Based on individual product requirements, member co-payments and limitations may vary for bone mineral density (BMD) testing.

In geographic areas with a capitated radiology program, BMD testing is included in the capitated radiology program. For preferred provider organization (PPO) members who use in-network providers, BMD testing is eligible for reimbursement when performed by a contracted diagnostic radiology provider and by certain participating specialists as defined under the radiology network rules.

FRACTURE PROBABILITY

The US-adapted World Health Organization (WHO) 10-year probability of a hip fracture and the 10-year fracture probability of any major osteoporosis-related fracture can be assessed using the Fracture Risk Assessment Tool (FRAX). This tool uses clinical risk factors with or without femoral neck bone density to calculate the 10-year probability of a major osteoporotic fracture (in the proximal part of the humerus, wrist, or hip or a clinical vertebral fracture) and a hip fracture calibrate to the fracture and death hazards. FRAX is not used for individuals 40 to 90 years of age who have already received pharmacologic treatment for osteoporosis.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, BMD testing is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

However, services that are identified in this policy as not medically necessary are not eligible for coverage or reimbursement by the Company.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are numerous devices approved by the FDA for BMD testing.

Description

Bone strength, an aggregate of bone density and bone quality, is an important factor in bone health and resistance to fracture. Bone density is defined as the amount of mineral in a specific area, while bone quality refers to architecture, turnover, and mineralization. Low bone density and deterioration of bone tissue result in osteoporosis, a disease marked by an increase in bone fragility and susceptibility to fracture. Chronic diseases, surgical procedures to reduce caloric intake (e.g., bariatric surgery), or medical conditions such as anorexia nervosa and long-term glucocorticoid therapy can contribute to bone loss and are associated with secondary osteoporosis. Osteoporosis is an extremely common disease in the elderly due to age-related bone loss in both sexes and menopause-related bone loss in women. The World Health Organization (WHO) defines osteoporosis based on a bone mineral density that is 2.5 standard deviations or more below that found in healthy, young individuals.

The WHO Bone mineral density (BMD) measurement is the standard used for diagnosing osteoporosis. Bone density studies are used to identify individuals with osteoporosis and also may be used to monitor response to osteoporosis treatment. The tests are noninvasive, and their accuracy for predicting the risk of fracture has been compared with the use of cholesterol testing to predict heart disease and hypertension for stroke. BMD is measured in the central (hip and lumbar spine) or peripheral (forearm, wrist, finger, or heel) skeleton. Because most fractures occur in the hip and spine, measurements of the central skeleton are most predictive of fracture risk at these sites. The following are established methods for BMD testing:
  • Dual-energy X-ray absorptiometry (DXA, DEXA)
  • Single-energy X-ray absorptiometry (SEXA)
  • Radiographic absorptiometry (RA)
  • Quantitative computed tomography (QCT)
  • Ultrasound BMD studies (i.e., bone sonometry)

Dual-energy X-ray absorptiometry (DXA, DEXA) is the most widely used central densitometry and is considered to be the gold standard. Scan time is short, and radiation exposure is very low. Measurement of density at the proximal femur is used to predict fractures, while measurement of the lumbar spine is used to monitor response to treatment. Quantitative computed tomography (QCT) (also a central measurement), which is a three-dimensional BMD test, is calculated using the differential absorption of ionizing radiation by calcified tissue. Standard CT scanners can be used. QCT is the only technique that can distinguish between cortical and cancellous bone. QCT is expensive, is not widely available, and has relatively high radiation exposure.

Examples of peripheral measurements include peripheral DXA (pDXA), which measures BMD at the forearm, wrist, heel, or finger; or peripheral QCT (pQCT), which measures the wrist. Radiographic absorptiometry (RA) measures BMD at the metacarpals and phalanges. Radiographic quantitative ultrasound (QUS) measures BMD at the heel utilizing sound waves. SEXA measures BMD at the forearm. SEXA is not widely used in current practice.

Two additional methods to measure BMD are single photon absorptiometry and dual photon absorptiometry. Single photon absorptiometry provides a quantitative measurement of bone mineral and trabecular bone. Dual photon absorptiometry measures the absorption of a dichromatic beam by bone material. In current practice, these methods are rarely used. In particular, dual photon absorptiometry may be considered obsolete.

Pulse echo ultrasound is an additional method to estimate the density index. The density index is an estimate of pelvic bone mineral density. Pulse echo ultrasound measures the cortical thickness at the upper shaft of the tibia. The measurement and other clinical risk factors or individual characteristics are used to calculate the density index. Clinical studies have shown that pulse echo ultrasound may be useful at identifying individuals at increased risk for osteoporosis, but additional studies are needed to confirm the accuracy of predicting subsequent clinical fractures.

Various clinical and interest groups, including the National Osteoporosis Foundation (NOF), the US Preventive Services Task Force (USPSTF), the Centers for Medicare & Medicaid Services (CMS), the International Society for Clinical Densitometry (ISCD), American College of Obstetricians and Gynecologists (ACOG), National Institutes of Health, the American Association of Clinical Endocrinologists, and the American Gastroenterological Association have published clinical guidelines for BMD testing. However, at this time, no definitive consensus has emerged. The USPSTF recommends initial BMD screening for all women over the age of 65 and postmenopausal females under the age of 65 at increased risk of osteoporosis. The NOF recommends screening for postmenopausal females who are younger than 65 years of age and have one additional risk factor. The NOF agrees with the USPSTF recommendation that females 65 years of age and older should be screened and adds the recommendation that males 70 years of age and older be tested regardless of risk factors. The NOF further provides indications for bone mineral testing for males between the ages of 50 and 69 years of age.

PRACTICE GUIDELINES AND POSITION STATEMENTS

AMERICAN COLLEGE OF OBSTETRICIANS AND GYNECOLOGISTS

The ACOG (2012, reaffirmed 2016) updated its guidelines on managing osteoporosis in women. The guidelines recommended that BMD screening should begin for all women at age 65 years. In addition, the ACOG recommended screening for women younger than 65 years in whom the Fracture Risk Assessment Tool indicates a 10-year risk of osteoporotic fracture of at least 9.3. Alternatively, ACOG recommended BMD screening women younger than 65 or with any of the following risk factors (they are similar, but not identical to risk factors in the Fracture Risk Assessment Tool):

  • 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 2-year interval after treatment initiation is preferred to 1 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.

NATIONAL OSTEOPOROSIS FOUNDATION

The NOF (2014) updated its practice guidelines. The NOF guidelines recommended that all postmenopausal women and men ages 50 and older be evaluated clinically for osteoporosis risk to determine the need for BMD testing.

Indications for BMD testing included:

  • “[W]omen age 65 and older and men age 70 and older” regardless of clinical risk factors
  • “[P]ostmenopausal women and men above age 50-69, based on risk factors profile”
  • “[P]ostmenopausal women and men age 50 and older who have had an adult age fracture…”
  • “Adults with a condition … or taking a medication … associated with low bone mass or bone loss”

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

The NOF also indicated that:

“Central DXA [dual x-ray absorptiometry] 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 3-6 % at the hip and 2-4 % at the spine from test to test may be due to the precision error of the testing itself.”

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 with 15 years.”

AMERICAN COLLEGE OF RADIOLOGY

Appropriateness criteria from the American College of Radiology, updated in 2017, 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 of the lumbar spine and hip included but were not limited to the following patient populations:

1. All women age 65 years and older and men age 70 years and older (asymptomatic screening)

2. 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:


    a. Estrogen deficiency

    b. A history of maternal hip fracture that occurred after the age of 50 years

    c. Low body mass (less than 127 lb or 57.6 kg)

    d. History of amenorrhea (more than 1 year before age 42 years)


3. Women younger than age 65 years or men younger than age 70 years who have additional risk factors, including:

    a. Current use of cigarettes

    b. Loss of height, thoracic kyphosis


4. Individuals of any age with bone mass osteopenia, or fragility fractures on imaging studies such as radiographs, CT [computed tomography], or MRI [magnetic resonance imaging]

5. Individuals age 50 years and older who develop a wrist, hip, spine, or proximal humerus fracture with minimal or no trauma, excluding pathologic fractures

6. Individuals of any age who develop one or more insufficiency fractures

7. Individuals being considered for pharmacologic therapy for osteoporosis.

8. Individuals being monitored to:


    a. Assess the effectiveness of osteoporosis drug therapy.

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


INTERNATIONAL SOCIETY FOR CLINICAL DENSITOMETRY

The 2013 update of theInternational Society for Clinical Densitometry guidelines recommended bone density testing in the following patients:

  • “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 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 aged 70 and older.
  • Men under < 70 years … if they have a 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 whom evidence of bone loss would lead to treatment.”

AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY

The American Association of Clinical Endocrinologists and American College of Endocrinology (2016) 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…
  • Determining fracture risk…
  • Identifying candidates for pharmacologic intervention
  • Assessing changes in bone density over time…
  • Enhancing acceptance of, and perhaps adherence with, treatment
  • Assessing skeletal consequences of diseases, conditions, or medications known to cause bone loss”

US 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.


CLINICAL PRACTICE GUIDELINES FOR THE CARE OF GIRLS AND WOMEN WITH TURNER SYNDROME

The Clinical Practice Guidelines for the Care of Girls and  Women with Turner Syndrome (Gravholt, et al., 2017) recommends a DEXA scan every 5 years due to the increased risk of osteoporosis in these patients.


FINITE ELEMENT ANALYSIS

Quantitative computed tomography-based finite element analysis (QCT/FEA) estimates fracture strength using 3D bone mineral distribution and geometry. The finite element analysis (FEA) is a computer simulation method, which is being investigated as a tool for bone fragility prediction. FEA considers both, the individual geometric and densitometric parameters retrieved from computed tomography imaging. In homogenized continuum level voxel based FE (hvFE) models, voxels are directly converted to hexahedral elements with specific homogenized material properties depending on local bone density. An example of a FEA test is the VirtuOst test. FEA ) is the central technology used in the proprietary VirtuOst test to conduct a "virtual" stress test for determining breaking strength. This virtual stress test considers the amount of bone mass a patient has, as well as bone size, shape, and internal structure, and provides analysis called Biomechanical Computer Tomography Analysis (BCT), CT-based measurements for BMD and bone strength.

Johannesdottir and associates (2018) reviewed the ability of CT-based methods (e.g., finite element analysis [FEA]) to predict incident hip and vertebral fractures. These investigators stated that CT-based techniques with concurrent calibration all showed strong associations with incident hip and vertebral fracture, predicting hip and vertebral fractures as well as, and sometimes better than, dual-energy X-ray absorptiometry areal biomass density (DXA aBMD). There is growing evidence for use of routine CT scans for bone health assessment. These investigators noted that CT-based techniques provide a robust approach for osteoporosis diagnosis and fracture prediction. It remains to be seen if further technical advances will improve fracture prediction compared to DXA aBMD. Future work should include more standardization in CT analyses, establishment of treatment intervention thresholds, and more studies to determine whether routine CT scans can be efficiently used to expand the number of individuals who undergo evaluation for fracture risk.

Groenen and colleagues (2018) noted that current FE models predicting failure behavior comprise single vertebrae, thereby neglecting the role of the posterior elements and intervertebral discs. These investigators developed a more clinically relevant, case-specific non-linear FE model of 2 functional spinal units able to predict failure behavior in terms of the vertebra predicted to fail; deformation of the specimens; stiffness; and load to failure. In addition, they examined the effect of different bone density-mechanical properties relationships (material models) on the prediction of failure behavior. Twelve 2 functional spinal units (T6 to T8, T9 to T11, T12 to L2, and L3 to L5) with and without artificial metastases were destructively tested in axial compression. These experiments were simulated using CT-based case-specific non-linear FE models. Bone mechanical properties were assigned using 4 commonly used material models. In 10 of the 11 specimens, the FE model was able to correctly indicate which vertebrae failed during the experiments. However, predictions of the three-dimensional (3D) deformations of the specimens were less promising. Whereas stiffness of the whole construct could be strongly predicted (R2  = 0.637 to 0.688, p < 0.01), these researchers obtained weak correlations between FE predicted and experimentally determined load to failure, as defined by the total reaction force exhibiting a drop in force (R2  = 0.219 to 0.247, p > 0.05). Furthermore, they found that the correlation between predicted and experimental fracture loads did not strongly depend on the material model implemented, but the stiffness predictions did. The authors concluded that whereas the FE model was able to correctly indicate which vertebrae failed during the experiments, it had difficulties predicting the 3D deformation of the specimens. In addition, stiffness could be strongly predicted by this model, but these researchers obtained weak correlations between FE predicted and experimentally determined vertebral strength. Thus, this work showed that, in its current state, the FE models may be used to identify the weakest vertebra, but that substantial improvements are needed to quantify in-vivo failure loads.

These investigators stated that the FE model might profit from more realistic intervertebral discs (IVDs) models.  In contrast to the bone material behavior, the IVD properties used in this study were not case-specific but obtained from the literature.  However, both the type of material model and values for coefficients used in previous FE studies varied highly.  The effect of these varying parameters on predictions of vertebral stiffness and/or bone strength is not well-studied.  Thus, effort could be put in determining (case‐specific) mechanical properties of IVD tissue, and, subsequently, in examining how implementing these properties in FE models affects the failure behavior of both single vertebra and 2 functional spinal units.  In addition, gaining more insight into the effect of IVD properties on endplate failure would be valuable, as endplate failure could not be captured correctly by the current FE model.  For this reason, emphasis should also be put on further characterizing and adequately simulating the endplates’ mechanical properties.  Furthermore, in case of sufficient resources and anatomical specimens, it would be interesting to combine testing of 2 functional spinal units with single vertebra tests; thus, the validity of the material models could be better tested.  These researchers also stated that whereas in the experiments soft tissues, including the spinal ligaments and facet capsules, were left intact, these structures were not accounted for in the FE simulations.  Spinal ligaments may contribute to the specimens’ stiffness and strength, especially when moving in flexion, extension, or lateral bending.  As these researchers allowed the specimens to pivot around the load application point, such movements could occur.  Adding ligaments and facet capsules to the FE model provides loading conditions being more realistic and better mimicking the experimental conditions, which potentially results in a better predictive capacity of the FE model.


Rajapakse and Chang (2018) noted that hip fractures have catastrophic consequences. These investigators reviewed recent developments in high-resolution magnetic resonance imaging (MRI)-guided FEA of the hip as a means to determine subject-specific bone strength. Despite the ability of DXA to predict hip fracture, the majority of fractures occur in patients who do not have BMD T scores less than - 2.5. Thus, without other detection methods, these individuals go undetected and untreated. Of methods available to image the hip, MRI is currently the only one capable of depicting bone microstructure in-vivo. Availability of micro-structural MRI allowed generation of patient-specific micro-FE models that can be used to simulate real-life loading conditions and determine bone strength. The authors concluded that MRI-based FEA enabled radiation-free approach to evaluate hip fracture strength. These researchers stated that with further validation, this technique could become a potential clinical tool in managing hip fracture risk.

Allaire and co-workers (2019) stated that previous studies showed vertebral strength from CT-based FEA may be associated with vertebral fracture risk. These investigators found vertebral strength had a strong association with new vertebral fractures, suggesting that vertebral strength measures may identify those at risk for vertebral fracture and may be a useful clinical tool. In a case-control study, these researchers examined the association between vertebral strength by QCT-based FEA and incident vertebral fracture (VF). In addition, they determined sensitivity and specificity of previously proposed diagnostic thresholds for fragile bone strength and low BMD in predicting VF. A total of 26 incident VF cases (13 men, 13 women) and 62 age- and sex-matched controls aged 50 to 85 years were selected from the Framingham multi-detector CT cohort. Vertebral compressive strength, integral volumetric BMD (vBMD), trabecular vBMD, CT-based BMC, and CT-based aBMD were measured from CT scans of the lumbar spine. Lower vertebral strength at baseline was associated with an increased risk of new or worsening VF after adjusting for age, BMI, and prevalent VF status (OR = 5.2 per 1 SD decrease, 95 % CI: 1.3 to 19.8). Area under receiver operating characteristic (ROC) curve comparisons revealed that vertebral strength better predicted incident VF than CT-based aBMD (AUC = 0.804 versus 0.715, p = 0.05); but was not better than integral vBMD (AUC = 0.815) or CT-based BMC (AUC = 0.794). Furthermore, proposed fragile bone strength thresholds trended toward better sensitivity for identifying VF than that of aBMD-classified osteoporosis (0.46 versus 0.23, p = 0.09). The authors concluded that the findings of this study showed an association between vertebral strength measures and incident vertebral fracture in men and women. These researchers stated that although limited by a small sample size (n = 26), these findings also suggested that bone strength estimates by CT-based FEA provided equivalent or better ability to predict incident vertebral fracture compared to CT-based aBMD. These findings need to be validated by well-designed studies.

Westbury and colleagues (2019) noted that high-resolution peripheral QCT (HRpQCT) is increasingly used for examining associations between bone micro-architectural and FEA parameters and fracture. These researchers hypothesized that combining bone micro-architectural parameters, geometry, BMD and FEA estimates of bone strength from HRpQCT may improve discrimination of fragility fractures. The analysis sample comprised of 359 subjects (aged 72 to 81 years) from the Hertfordshire Cohort Study (HCS). Fracture history was determined by self-report and vertebral fracture assessment. Subjects underwent HRpQCT scans of the distal radius and DXA scans of the proximal femur and lateral spine. Poisson regression with robust variance estimation was used to derive relative risks (RRs) for the relationship between individual bone micro-architectural and FEA parameters and previous fracture. Cluster analysis of these parameters was then performed to identify phenotypes associated with fracture prevalence. Receiver operating characteristic analysis suggested that bone micro-architectural parameters improved fracture discrimination compared to areal BMD (aBMD) alone, whereas further inclusion of FEA parameters resulted in minimal improvements. Cluster analysis (k-means) identified 4 clusters. The 1st had lower Young modulus, cortical thickness, cortical volumetric density and Von Mises stresses compared to the wider sample; fracture rates were only significantly greater among women (RR [95 % CI] compared to lowest risk cluster: 2.55 [1.28 to 5.07], p = 0.008). The 2nd cluster in women had greater trabecular separation, lower trabecular volumetric density and lower trabecular load with an increase in fracture rate compared to lowest risk cluster (1.93 [0.98 to 3.78], p = 0.057). These findings may help inform intervention strategies for the prevention and management of osteoporosis. The authors concluded that micro-architectural deterioration, bone geometry and, in women, FEA-derived bone strength contributed to an increased risk of previous fracture. Cluster analysis revealed a cortical and a trabecular deficiency phenotype, which both showed lower aBMD in men and women. Only women with the cortical deficiency phenotype had significantly increased risk of previous fractures. In this cohort, adding bone micro-architectural parameters to aBMD could better predict previous fracture, but further addition of FEA conferred little benefit.

The authors stated that this study had several drawbacks. First, a healthy responder bias has been observed in HCS and examining subject characteristics according to inclusion status has revealed healthier lifestyles at baseline for subjects included in the analysis sample compared to those who were not. However, these analyses were internal, so bias would only arise if the associations of Interest differed systematically between those who were included in the analysis sample and those who were not; this appeared unlikely. Second, temporal causation could not be inferred as this study had a cross-sectional design. It may be that the differences in bone microstructure observed were secondary to re-modelling in response to fracture, rather than properties of the bone that predispose to fracture, especially as these researchers had only collected information regarding previous fractures. Third, fracture status was missing for some subjects, although this information was available for the vast majority (91.9 %) of the analysis sample. Fourth, the low numbers of reported fractures and a relatively small sample size, along with the lack of stability regarding cluster analysis algorithms in general, may limit the generalizability of findings. However, the similarity of the clusters observed to those in other analyses and their biological plausibility suggested that they were robust.

In a review by Lewiecki, 2019 on “Osteoporotic fracture risk assessment,” the author lists FEA as one of the new and emerging technologies. The review states that “Finite element analysis (FEA) uses computer models of images and data from QCT of the spine or hip to assess bone strength. QCT-based FEA can be used to predict vertebral fracture in postmenopausal women and is comparable with spine DXA in predicting vertebral fractures in men; it is also comparable with hip DXA in predicting hip fractures in postmenopausal women and older men. FEA cannot be used to diagnose osteoporosis, initiate therapy, or monitor therapy. While all of these technologies have provided insight into skeletal properties other than BMD that determine bone strength, their role in clinical practice has not been defined. These techniques are used primarily in research settings”.


SUMMARY

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. The 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.

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. The 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.

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. The 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 (i.e., 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.

For individuals who are eligible for screening of BMD based on risk factor assessment who receive ultrasound densitometry, or quantitative computed tomography (including CT-based methods such as finite element analysis [FEA]), or DXA analysis of peripheral sites, the evidence includes observational studies and systematic reviews. The 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.


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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)


MEDICALLY NECESSARY

76977, 77078, 77080, 77081

NOT MEDICALLY NECESSARY

78350, 78351

EXPERIMENTAL/INVESTIGATIONAL

0508T, 0554T, 0555T, 0556T, 0557T, 0558T


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

N/A


HCPCS Level II Code Number(s)



MEDICALLY NECESSARY

G0130 Single energy x-ray absorptiometry (SEXA) bone density study, one or more sites; appendicular skeleton (peripheral) (eg, radius, wrist, heel)



Revenue Code Number(s)

N/A


Misc Code

N/A:



Coding and Billing Requirements


Cross References


Policy History

Revisions from 09.00.04k
03/11/2020This version of the policy will become effective 03/11/2020.

Revised policy number 09.00.04k was issued as a result of the department's annual policy review. The references were updated accordingly. The policy was updated to be consistent with current template wording and format.

This policy update communicates that finite element analysis, (e.g., VirtuOst test), is considered experimental/investigational and, therefore, not covered for all indications, including but not limited to evaluation of fracture risk, diagnosis of osteoporosis, guidance to initiate therapy for osteoporosis, and monitoring of therapy because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

Included women with Tuner Syndrome to the medical necessity criteria.

Procedure code 0547T has been removed from this policy.

Revisions from 09.00.04j
07/01/2019This version of the policy went through a code update process effective July 01, 2019, and 0547T, 0554T, 0555T, 0556T, 0557T and 0558T on that date.

Revisions from 09.00.04i
11/19/2018This version of the policy will become effective 11/19/2018. The Company’s coverage position for pulse echo ultrasound was added to the policy. The following CPT code has been added to this policy: 0508T.


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 03/11/2020
Version Issued Date: 03/11/2020
Version Reissued Date: N/A



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