Cigna Bone Mineral Density Measurement - (0300) Form

The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Each coverage request should be reviewed on its own merits. Medical directors are expected to exercise clinical judgment and have discretion in making individual coverage determinations. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations. This Coverage Policy addresses bone mineral density measurement, fracture risk assessment, and vertebral fracture screening. Coverage Policy In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations. SCREENING Coverage for preventive care including bone mineral density measurement for screening for osteoporosis varies across plans. Refer to the customer’s benefit plan document for coverage details. Any of the following bone mineral density measurement testing methods is considered medically necessary as screening for osteoporosis: Medical Coverage Policy: 0300 peripheral ultrasound (CPT® 76977) • • peripheral DXA (CPT® 77081) • peripheral single energy x-ray absorptiometry (HCPCS code G0130) central dual x-ray absorptiometry (DXA) (CPT® 77080) for ANY of the following indications: women ≥ 65 years of age and men ≥ 70 years of age • younger postmenopausal women, women in the menopausal transition, and men aged 50 to 69 years with clinical risk factors for fracture (see Appendix) • adults who have a fracture at age 50 years and older • adults with a condition (e.g., rheumatoid arthritis, organ transplant) or taking a medication (e.g., glucocorticoids, aromatase inhibitors, androgen deprivation therapy) associated with low bone mass or bone loss Computed tomography (CT) (CPT® 77078) for bone mineral density measurement testing is considered medically necessary as screening for osteoporosis when DXA scanner is unavailable or known to be inaccurate for ANY of the following indications: women ≥ 65 years of age and men ≥ 70 years of age • younger postmenopausal women, women in the menopausal transition, and men aged 50 to 69 years with clinical risk factors for fracture (see Appendix) • adults who have a fracture at age 50 years and older • adults with a condition (e.g., rheumatoid arthritis, organ transplant) or taking a medication (e.g., glucocorticoids, aromatase inhibitors, androgen deprivation therapy) associated with low bone mass or bone loss Repeat bone density measurement is considered medically necessary every two years. Bone mineral density measurement for screening for osteoporosis for any other population is considered experimental, investigational or unproven. NON-SCREENING/MONITORING Any of the following bone mineral density measurement testing methods is considered medically necessary: peripheral ultrasound (CPT® 76977) • • peripheral DXA (CPT® 77081) • peripheral single energy x-ray absorptiometry (HCPCS code G0130) central dual x-ray absorptiometry (DXA) (CPT® 77080) for ANY of the following indications: prior to and during pharmacologic treatment for osteoporosis* • • • child or adolescent with a disease process known to adversely affect the skeleton known osteoporotic fracture individual with vertebral abnormalities as demonstrated by an x-ray to be indicative of osteoporosis, osteopenia, or vertebral fracture central DXA assessment of the hip or lumbar spine is preferred Computed tomography (CT) (CPT® 77078) for bone mineral density measurement testing is considered medically necessary when DXA scanner is unavailable or known to be inaccurate for ANY of the following indications: Medical Coverage Policy: 0300 multiple healed compression fractures • • advanced arthritis of the spine due to increased cortical sclerosis often with large marginal osteophytes. • • obese individual over the weight limit of the DXA exam table or BMI >35kg/m2 • extremes in body height (i.e., very large and very small individuals) • extensive degenerative disease of the spine • a clinical scenario that requires sensitivity to small changes in trabecular bone density (parathyroid hormone and glucocorticoid treatment monitoring) significant scoliosis follow-up in cases where QCT was the original study Repeat bone density measurement is considered medically necessary no earlier than one year following a change in treatment regimen, and only when the results will directly impact a treatment decision. Non-screening/monitoring bone mineral density measurement for any other indication is considered experimental, investigational or unproven. VERTEBRAL FRACTURE ASSESSMENT/SCREENING Vertebral fracture assessment from dual-energy x-ray absorptiometry (DXA) (CPT® 77085-77086) is considered medically necessary for ANY of the following individuals***: women aged ≥ 65 years and all men aged ≥ 80 years if T-score at the lumbar spine, total hip, or femoral neck is ≤ − 1.0 men aged 70 to 79 years if T-score at the lumbar spine, total hip, or femoral neck is ≤ − 1.5 • postmenopausal women and men age ≥ 50 years with the following specific risk factors:   historical height loss of 1.5 in. or more*  prospective height loss of 0.8 in. or more**   medical conditions associated with bone loss such as hyperparathyroidism fracture during adulthood (age ≥ 50 years) recent or ongoing long-term glucocorticoid treatment Current height compared to peak height during young adulthood **Cumulative height loss measured during interval medical assessment ***If bone density testing is not available, vertebral imaging may be considered based on age alone Vertebral fracture assessment from imaging scans other than DXA (e.g., CPT® 0691T, 0743T) for any indication is considered experimental, investigational or unproven. BONE STRENGTH AND FRACTURE RISK ASSESSMENT Bone strength and fracture risk assessment from imaging scans other than DXA (e.g., CPT® 0554T- 0557T, 0558T, 0743T, 0749T-0750T) for any indication is considered experimental, investigational or unproven. PULSE-ECHO ULTRASOUND Pulse-echo ultrasound for bone mineral density measurement testing is considered experimental, investigational or unproven (CPT® 0508T). TRABECULAR BONE SCORE (TBS) Trabecular bone score (CPT® 77089 – 77092) for any indication is considered experimental, investigational or unproven. Medical Coverage Policy: 0300 General Background Osteoporosis is the most common bone disease in humans; characterized by low bone mass, deterioration of bone tissue and disruption of bone architecture, compromised bone strength and an increase in the risk of fracture. There are numerous conditions or diseases that are clinical risk factors for osteoporosis including lifestyle factors, genetic diseases, hypogonadal states, endocrine disorders, gastrointestinal disorders, hematologic disorders, rheumatologic and autoimmune diseases, and medications (see Appendix). Osteoporosis is a silent disease until it is complicated by fractures—fractures that can occur following minimal trauma. Osteoporosis can be prevented, diagnosed and treated before any fracture occurs. Importantly, even after the first fracture has occurred, there are effective treatments to decrease the risk of further fractures. It is estimated that 18.8% of women and 4.2% of men 50 years of age and over have osteoporosis of the femur neck or lumbar spine. Bone Mineral Density (BMD) Testing of bone mineral density (BMD) is useful for screening and monitoring therapy in people at high risk for osteoporosis (e.g., postmenopausal women, patients with hyperparathyroidism or other bone disorders, or those being treated with medications associated with bone loss [e.g., glucocorticoids]), if evidence of bone loss would result in modification of therapy. Testing of BMD is the gold standard in diagnosing osteoporosis; however, not everyone has access to BMD testing. Therefore, the decision to measure BMD should be based on an individual’s clinical fracture risk profile and skeletal health assessment. Dual-energy X-ray Absorptiometry (DXA) of the lumbar spine and proximal femur (hip) provides accurate and reproducible BMD measurements at important sites of osteoporosis-associated fracture. Optimally, both hips should be initially measured to prevent misclassification and to have a baseline for both hips in case a fracture or replacement occurs in one hip. These axial sites are preferred over peripheral sites for both baseline and serial measurements. The most reliable comparative results are obtained when the same instrument and, ideally, the same technologist are used for serial measurements at a high-quality DXA facility. BMD is compared to 2 norms—healthy young adults (T-score) and age-matched adults (Z-score). First, BMD result is compared with the BMD results from healthy 25- to 35-year-old adults of the same sex and ethnicity. The standard deviation (SD) is the difference between the BMD and that of the healthy young adults. This result is the T-score. Positive T-scores indicate the bone is stronger than normal; negative T-scores indicate the bone is weaker than normal. In general, the risk for bone fracture doubles with every SD below normal. According to the World Health Organization, osteoporosis is defined based on the following bone density levels: A T-score within 1 SD (+1 or -1) of the young adult mean indicates normal bone density. • A T-score of 1 to 2.5 SD below the young adult mean (-1 to -2.5 SD) indicates low bone mass. • A T-score of 2.5 SD or more below the young adult mean (more than -2.5 SD) indicates the presence of osteoporosis. Diagnostic criteria, therapeutic studies, and cost-effectiveness data have been based primarily on DXA measurements of the total hip, femoral neck, and/or lumbar spine (L1 to L4) and are the preferred measurement sites. The 1/3 radius can also be used as a diagnostic site, particularly when other preferred sites are not available. Use of other sub-regions within the proximal femur (i.e., Ward’s triangle or trochanter) or of an individual vertebra has not been validated and is not recommended. When BMD testing by DXA is not available, then fracture risk assessment may be made using other technologies (measuring lumbar spine, hip, or peripheral skeletal sites) in combination with consideration of clinical risk factors. Several other techniques are available for BMD measurement including quantitative computed tomography for measurement of both central and peripheral sites, quantitative ultrasonometry, radiographic absorptiometry, and single-energy X-ray absorptiometry. Peripheral bone density measurements can identify patients at increased risk for fracture; however, the diagnostic DXA criteria established by the World Health Organization (WHO) and recommended by the American Association of Clinical Endocrinologists (AACE) Medical Coverage Policy: 0300 apply only to the axial measurements (i.e., lumbar spine, femoral neck, and total hip) and distal 1/3 of the radius. Thus, other technologies should not be used to diagnose osteoporosis but may be used to assess fracture risk. In an editorial, Lewiecki et al. (2020) stated there are racial disparities in the care of osteoporosis. Several studies have shown that Black women are less likely to be treated for osteoporosis than white women overall as well as in the presence of fractures. A study looking at disparities in outcomes after an osteoporotic fracture demonstrated that after adjusting for age, Black women had a significantly higher risk of death, disability, and destitution than whites for most fracture types. The author stated that disparities must be fully recognized by the healthcare community, and aggressive efforts should be made to correct them. The author noted that there is currently a crisis in the care of osteoporosis, with most patients, even those with very high risk of fracture, often not being identified and not receiving effective treatment. FRAX® BMD testing is a powerful tool, but clinical risk factors also significantly influence fracture risk in individual patients. The FRAX® (Fracture Risk Assessment) tool is widely available and incorporates multiple clinical risk factors that predict fracture risk, largely independent of BMD. The FRAX® tool has been developed by World Health Organization Collaborating Centre for Metabolic Bone Diseases (Sheffield, United Kingdom) to evaluate fracture risk of patients. It is based on individual patient models that integrate the risks associated with clinical risk factors as well as BMD at the femoral neck. The FRAX models have been developed from studying population-based cohorts from Europe, North America, Asia and Australia. In their most sophisticated form, FRAX is available on newer DXA machines or with software upgrades that provide the FRAX scores on the bone density report. The FRAX tool is computer-driven and is available online. Also, several simplified paper versions, based on the number of risk factors are also available, and can be downloaded for office use. The FRAX algorithms give the 10-year probability of fracture. The output is a 10-year probability of hip fracture and the 10- year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture). Professional Societies/Organizations Bone Health & Osteoporosis Foundation (BHOF) / (previously known as National Osteoporosis Foundation (NOF): The BHOF Clinician’s Guide to Prevention and Treatment of Osteoporosis (LeBoff, et al., 2022) states Consider BMD testing in the following individuals: Women ≥ 65 years of age and men ≥ 70 years of age, regardless of clinical risk factors • Younger postmenopausal women, women in the menopausal transition, and men aged 50 to 69 years with clinical risk factors for fracture Adults who have a fracture at age 50 years and older • Adults with a condition (e.g., rheumatoid arthritis, organ transplant) or taking a medication (e.g., glucocorticoids, aromatase inhibitors, androgen deprivation therapy) associated with low bone mass or bone loss DXA measurement of hip and lumbar spine is the preferred method for establishing and/or confirming a diagnosis of osteoporosis, predicting future fracture risk, and monitoring patients. Areal BMD by DXA is expressed in absolute terms of grams of mineral per square centimeter scanned (g/cm2) and as a relationship to two BMD norms: an age-, sex-, and ethnicity-matched reference population (Z-score), or a young-adult reference population (T-score). American Association of Clinical Endocrinologists (AACE): The AACE and American College of Endocrinology (ACE) Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis (Camacho, et. al., 2020) list these indications for bone mineral density testing: All women 65 years of age or older • All postmenopausal women  With a history of fracture(s) without major trauma  With osteopenia identified radiographically  Starting or taking long-term systemic glucocorticoid therapy (≥3 months) Medical Coverage Policy: 0300 Other perimenopausal or postmenopausal women with risk factors for osteoporosis if willing to consider pharmacologic interventions  Low body weight (<127 lb or body mass index <20 kg/m2)  Long-term systemic glucocorticoid therapy (≥3 months)  Family history of osteoporotic fracture  Early menopause  Current smoking  Excessive consumption of alcohol Secondary osteoporosis American College of Obstetricians and Gynecologists (ACOG): The ACOG Clinical Practice Guideline No. 2 (April 2022) “suggests dual energy X-ray absorptiometry (DXA) testing every 1–3 years during osteoporosis pharmacotherapy, depending on clinical circumstances, until findings are stable (conditional recommendation, moderate–quality evidence).” American College of Radiology (ACR): The ACR Appropriateness Criteria® for Osteoporosis and Bone Mineral Density (2022) notes the following recommendations: Scenario Summary of Recommendation Osteoporosis screening or initial imaging of clinically suspected low bone mineral density DXA lumbar spine and hip(s) is usually appropriate for osteoporosis screening or initial imaging of clinically suspected low BMD. Follow-up imaging of patients demonstrated to have risk for fracture or surveillance of established low bone mineral density. DXA lumbar spine and hip(s) is usually appropriate for the follow-up imaging of patients demonstrated to have risk for fracture or surveillance of established low BMD. Follow-up imaging. Patients with T-scores less than −1.0 (by DXA) and one or more of the following: 1) Females equal to or greater than 70 years of age or males equal to or greater than 80 years of age; 2) Historical height loss greater than 4 cm (greater than 1.5 inches); 3) Self-reported but undocumented prior vertebral fracture; 4) Glucocorticoid therapy equivalent to equal to or greater than 5 mg of prednisone or equivalent per day for equal to or greater than 3 months. Initial imaging for premenopausal females or males less than 50 years of age. Individual with risk factors that could alter bone mineral density. Premenopausal females with risk factors. Males less than 50 years of age with risk factors. Follow-up to low bone mineral density. Males and females greater than or equal to 50 years of age. Suspected osteoporosis. Advanced degenerative changes of the spine with or without scoliosis, or other conditions DXA lumbar spine and hip(s) and DXA VFA is usually appropriate for the follow-up imaging of patients with T- scores less than −1.0 (by DXA) and one or more of the following: 1) Females equal to or greater than 70 years of age or males equal to or greater than 80 years of age; 2) Historical height loss greater than 4 cm (greater than 1.5 inches); 3) Self-reported but undocumented prior VF; 4) Glucocorticoid therapy equivalent to equal to or greater than 5 mg of prednisone or equivalent per day for equal to or greater than 3 months. VFA and DXA are complementary procedures that are performed concomitantly allowing point- of-care service at the same visit that one obtains a BMD measurement. DXA lumbar spine and hip(s) is usually appropriate for the initial imaging of patients with risk factors that could alter BMD including premenopausal females or males less than 50 years of age. DXA lumbar spine and hip(s) is usually appropriate for the imaging follow-up to low BMD of patients with risk factors including premenopausal females or males less than 50 years of age with risk factors. DXA distal forearm or DXA lumbar spine and hip(s) or QCT lumbar spine and hip is usually appropriate for the initial imaging of clinically suspected osteoporosis in patients with advanced degenerative changes of the spine with or without scoliosis, or other conditions that may spuriously elevate Medical Coverage Policy: 0300 Scenario that may spuriously elevate BMD. Initial imaging. Summary of Recommendation BMD. These procedures are equivalent alternatives (ie, only one procedure will be ordered to provide the clinical information to effectively manage the patient’s care). The ACR Practice Guideline for the Performance of Dual-energy x-ray Absorptiometry (DXA) (2018) states that dual-energy X-ray absorptiometry (DXA) is a clinically proven, accurate, and reproducible method of measuring bone mineral density (BMD) in the lumbar spine, proximal femur, forearm, and whole body. It is used primarily in the diagnosis and management of osteoporosis and other disease states characterized by abnormal BMD, as well as to monitor response to therapy for these conditions. DXA may also be used to measure whole-body composition, including non-bone lean mass (LM) and fat mass (FM). DXA-measured LM and FM may be helpful in assessing a number of conditions, including sarcopenia and cachexia. Contraindications: There are no absolute contraindications to performing DXA. However, a DXA examination may be of limited value or require modification of the technique or rescheduling of the examination in some situations, including: Recently administered oral contrast or radionuclides • Pregnancy • Severe degenerative changes or fracture deformity in the measurement area • • The patient’s inability to attain correct position and/or remain motionless for the measurement • Extremes of high or low body mass index that may adversely affect the ability to obtain accurate Implants, hardware, devices, or other foreign material in the measurement area measurements. QCT may be a desirable alternative in these individuals. The ACR Practice Guideline for the Performance of Musculoskeletal Quantitative Computed Tomography (QCT) (2018) states that musculoskeletal quantitative computed tomography (QCT) can be used to accurately and reproducibly measure bone mass or muscle mass. QCT is a clinically proven method of measuring bone mineral density (BMD) in the spine and proximal femur. QCT is used primarily in the diagnosis and management of osteoporosis and other disease states that may be characterized by abnormal BMD, as well as to monitor response to therapy for these conditions. United States Preventive Services Task Force (USPSTF): The USPSTF (2018) Osteoporosis to Prevent Fractures: Screening recommendations: The USPSTF recommends screening for osteoporosis with bone measurement testing to prevent osteoporotic fractures in women 65 years and older (Grade B - The USPSTF recommends the service). The USPSTF recommends screening for osteoporosis with bone measurement testing to prevent osteoporotic fractures in postmenopausal women younger than 65 years who are at increased risk of osteoporosis, as determined by a formal clinical risk assessment tool (Grade B - The USPSTF recommends the service). The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for osteoporosis to prevent osteoporotic fractures in men (Grade I – Insufficient). Several tools are available to assess osteoporosis risk: the Simple Calculated Osteoporosis Risk Estimation (SCORE; Merck), Osteoporosis Risk Assessment Instrument (ORAI), Osteoporosis Index of Risk (OSIRIS), and the Osteoporosis Self-Assessment Tool (OST). These tools seem to perform similarly and are moderately accurate at predicting osteoporosis. The FRAX tool (University of Sheffield), which assesses a person’s 10-year risk of fracture, is also a commonly used tool. The American Board of Internal Medicine’s (ABIM) Foundation Choosing Wisely® Initiative: The American College of Rheumatology (2013) recommends not routinely repeating DXA scans more often than once every two years. The American Academy of Family Physicians (2012) recommends that DXA scan not be used for screening for osteoporosis in women younger than 65 or men younger than 70 with no risk factors. The American Academy of Family Physicians states ‘Don’t use dual-energy x-ray absorptiometry (DEXA) screening Medical Coverage Policy: 0300 for osteoporosis in women younger than 65 or men younger than 70 with no risk factors’ (Released April 4, 2012). The Endocrine Society states ‘Don’t routinely measure 1,25-dihydroxyvitamin D unless the patient has hypercalcemia or decreased kidney function’ (2013). Men For men, osteoporosis is associated with increased morbidity and mortality, specifically following a fracture. It is currently estimated that approximately 5% of men in the United States have osteoporosis by T-score definition. Although this is less common than in women, increasing attention is being paid to osteoporosis in men given the significant morbidity and mortality associated with this condition. As many as 1 in 4 men older than 50 years will develop at least 1 osteoporosis-related fracture in their lifetime. The clinical measurement of bone mineral density using DXA remains the gold standard for diagnosis of osteoporosis in males; and fracture risk assessment is now recognized as a preferred approach to guide treatment decisions. In a review article, Adler et al. (2018) recommends targeted DXA testing for osteoporosis in men: Age ≥80 • Oral Glucocorticoid Use • Androgen Deprivation Therapy for Prostate Cancer • High Pre-screening FRAX Risk Score using BMI instead of BMD • Age ≥65 plus at least one of the following: Traditional Anti-Epileptic Drugs, Rheumatoid Arthritis, Alcohol Abuse, Current Smoking, BMI <25 kg/m2, Hyperthyroidism, Hyperparathyroidism, Chronic Obstructive Pulmonary Disease, Chronic Liver Disease, Stroke, Parkinson's Disease, Gastrectomy The BHOF Clinician’s Guide to Prevention and Treatment of Osteoporosis (LeBoff, et al., 2022) states Consider BMD testing in: men ≥ 70 years of age, regardless of clinical risk factors • men aged 50 to 69 years with clinical risk factors for fracture • adults who have a fracture at age 50 years and older • adults with a condition (e.g., rheumatoid arthritis, organ transplant) or taking a medication (e.g., glucocorticoids, aromatase inhibitors, androgen deprivation therapy) associated with low bone mass or bone loss The USPSTF (2018) Osteoporosis to Prevent Fractures Screening recommendations state that that the current evidence is insufficient to assess the balance of benefits and harms of screening for osteoporosis to prevent osteoporotic fractures in men (Grade I – Insufficient). The Endocrine Society Clinical Practice Guideline on Osteoporosis in Men recommends BMD testing should be performed in men who are higher risk men (aged ≥70 and men aged 50–69 who have risk factors (e.g. low body weight, prior fracture as an adult, smoking, etc.) The Endocrine Society recommends using DXA of the spine and hi or forearm DXA (when spine or hip BMD cannot be interpreted) and for men with hyperparathyroidism or receiving androgen deprivation therapy (ADT) for prostate cancer (Watts, et al., 2012). Serial BMD The BHOF Clinician’s Guide to Prevention and Treatment of Osteoporosis (LeBoff, et al., 2022) addresses Serial BMD Measurement under the section on Monitoring Treatment Response, and notes the following: Central DXA assessment of the total hip, femoral neck, or lumbar spine is the “gold standard” for serial assessment of BMD. The BHOF recommends repeating BMD assessments every 2 years in adults ages 65 and older, with the understanding that testing less or more frequently may be warranted in individual patients. DXA is currently the preferred approach for monitoring treatment response. The USPSTF (2018 Statement) Screening Intervals section states “Some observational and modeling studies have suggested screening intervals based on age, baseline BMD, and calculated projected time to transition to osteoporosis. However, limited evidence from 2 good-quality studies found no benefit in predicting fractures from repeating bone measurement testing 4 to 8 years after initial screening”. Medical Coverage Policy: 0300 Regarding monitoring treatment, the American Association of Clinical Endocrinologists (AACE) state to repeat DXA every 1 to 2 years until findings are stable. The 1/3 radius may be considered as an alternate site when the lumbar spine/hip are not evaluable or as an additional site in patients with primary hyperparathyroidism. Continue with follow-up DXA every 1 to 2 years or at a less frequent interval, depending on clinical circumstances. Follow-up of patients should ideally be conducted in the same facility with the same DXA system (Camacho, et al., 2020). Vertebral Fracture Assessment/Screening from DXA Many DXA devices have received 510(k) marketing clearance from the FDA, including but not limited to Hologic’s Instant Vertebral Assessment (IVA), GE’s Dual Energy Vertebral Assessment (DVA) (previously known as Lateral Vertebral Assessment (LVA) and SpineAnalyzer™ (Optasia Medical). Additional software and therefore 510(k) clearance is required to perform VFA on the DXA devices. Vertebral fracture assessment (VFA) is a low-dose lateral image of the thoracic and lumbar spine that may be added to a standard DXA to determine whether vertebral fractures are present. VFA should be considered in patients with height loss or back pain who have not been assessed by conventional radiographs, CT, or MRI. VFA is intended solely to identify whether spine compression is present and does not replace conventional diagnostic imaging for other purposes. Vertebral fracture is the most common osteoporotic fracture and indicates a high risk for future fractures, even when the T-score does not meet the threshold for osteoporosis. Prevalent fractures, therefore, may change an individual’s diagnostic classification, estimated risk of future fractures, and clinical management. Most vertebral fractures, however, remain undetected unless specifically sought by imaging techniques (spine X-ray or vertebral fracture assessment [VFA]) (Camacho, et. al., 2020). American Association of Clinical Endocrinologists (AACE): The AACE and American College of Endocrinology (ACE) Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis (Camacho, et. al., 2020) states Lateral spine imaging with standard radiography or VFA with DXA is indicated when T-score is less than −1.0 AND one or more of the following is present: Women aged ≥70 years or men aged ≥80 years • Historical height loss >4 cm (>1.5 inches) • Self-reported but undocumented prior vertebral fracture • Glucocorticoid therapy equivalent to ≥5 mg of prednisone or equivalent per day for ≥3 months Bone Health & Osteoporosis Foundation (BHOF) / (previously known as National Osteoporosis Foundation (NOF): The BHOF Clinician’s Guide to Prevention and Treatment of Osteoporosis (LeBoff, et al., 2022) states that vertebral fracture imaging (X-ray or DXA vertebral fracture assessment) should be performed in high risk individuals to detect subclinical vertebral fractures. Because subclinical vertebral fractures are so prevalent in older individuals, vertebral fracture assessment is recommended for these high-risk individuals*** • All women aged ≥ 65 years and all men aged ≥ 80 years if T-score at the lumbar spine, total hip, or femoral neck is ≤ − 1.0 Men aged 70 to 79 years if T-score at the lumbar spine, total hip, or femoral neck is ≤ − 1.5 • Postmenopausal women and men age ≥ 50 years with specific risk factors:  Fracture during adulthood (age ≥ 50 years)  Historical height loss of 1.5 in. or more*  Prospective height loss of 0.8 in. or more**  Recent or ongoing long-term glucocorticoid treatment  Medical conditions associated with bone loss such as hyperparathyroidism Current height compared to peak height during young adulthood **Cumulative height loss measured during interval medical assessment ***If bone density testing is not available, vertebral imaging may be considered based on age alone Medical Coverage Policy: 0300 USPSTF: The most recent recommendation from the U. S. Preventive Services Task Force on screening for osteoporosis does not address this technology. Vertebral Fracture Assessment/Screening and Bone Strength and Fracture Risk Assessment from Imaging Modalities Other than DXA U.S. Food and Drug Administration (FDA): On August 3, 2018, VirtuOst Vertebral Fracture Assessment (O.N. Diagnostics, LLC.) received 510(k) approval (K171435). Indications for use include: “VirtuOst VFA uses sagittal sections from a spine-containing CT scan, with or without contrast enhancement, to visualize and measure vertebral deformities, classify the type and grade of any existing vertebral fracture, and from this identify patients at high risk of a future osteoporosis-related fracture. This information can be interpreted by a physician to diagnose existing vertebral fractures and to manage patients for osteoporosis.” Using non-linear finite element analysis (FEA), VirtuOst provides a whole-bone strength (in units of newtons) of the hip and/or spine. The patient’s CT scan is sent to the company electronically, the analysis performed by the company and the results sent back to the ordering physician. On May 12, 2020, 510(k) approval was granted for HealthVCF (K192901) to Zebra Medical Vision Ltd. (Israel). The Indications for Use states: HealthVCF is a passive notification for prioritization-only, parallel-workflow software tool used by clinicians to prioritize specific patients within the standard-of-care bone health setting for suspected vertebral compression fractures. HealthVCF uses an artificial intelligence algorithm to analyze chest and abdominal CT scans and flags those that are suggestive of the presence of at least one vertebral compression at the exam level. These flags are viewed by the clinician in Bone Health and Fracture Liaison Service programs in the medical setting via a worklist application on their Picture Archiving and Communication System (PACS). HealthVCF does not send a proactive alert directly to the user. HealthVCF does not provide diagnostic information beyond triage and prioritization, it does not remove cases from the radiology worklist, and should not be used in place of full patient evaluation, or relied upon to make or confirm diagnosis. Of note, on August 10, 2021 Nanox (Israel) signed an agreement to purchase Zebra. Nanox uses the product name ‘Bone Health Solution’, instead of HealthVCF. On April 22, 2022, 510(k) approval was granted for HealthOST (NanoxAI Ltd., Israel), a computed tomography x- ray system. HealthOST is an image processing software that provides qualitative and quantitative analysis of the spine from CT images to support clinicians in the evaluation and assessment of musculoskeletal disease of the spine. HealthOST is indicated for use in patients aged 50 and over undergoing CT scan for any clinical indication, that includes at least four vertebrae in the T1-L4 portion of the spine (for vertebral height loss) and T11-L4 (for bone attenuation) portions of the spine. On June 7, 2002, 510(k) approval was granted for Sectra Osteoporosis Package (K021527) to Sectra Imtec AB (Sweden). Sectra Osteoporosis Package analyzes radiography images obtained directly in digital format. Predicate Device was X-Posure System Version 2 RAD (Pronosco A/S) (K002500, 10/23/2000). Sectra purchased Pronosco in 2002. Indications for Use: The device is intended for use to estimate bone mineral density (“BMD”) in the forearm and to assess increased risk of osteoporotic fracture according to World Health Organization (“WHO”) criteria. The device is indicated specifically for use to: (1) assist the physician in diagnosing subjects who already have been identified to be at risk for suffering from osteoporosis, together with other known risk factors (e.g., prior history of fractures, advanced age, low body weight, lack of physical exercise, lack of exposure to sunlight, insufficient dietary intake of vitamin D and/or calcium, and smoking); and (2) compare the BMD estimate with a reference population comprised of young normals and age-matched normals to compute T-scores and 2-scores, respectively. Literature Review: The use of images other than DXA are proposed to identify individuals at high risk of fracture, or identify those with subclinical vertebral fractures. There is an increasing interest in performing concurrent bone health screening on patients who undergo diagnostic CT scans of the abdomen and pelvis. Additionally, digital X-ray radiogrammetry (DXR) is proposed to estimate hand BMD from hand x-ray images. There is a lack of well-designed clinical trials addressing the impact of algorithmic-based assessments of non- DXA scans on patient-specific long-term health outcomes (Kolanu, et al., 2020 [Zebra Medical Vision®]; Dagan, et al., 2020 [HealthVCF]; Allaire, et al., 2019 [VirtuOst]; Adams, et al., 2018 [VirtuOst]; Kälvesten, et al., 2016 Medical Coverage Policy: 0300 and Wilczek, et al., 2013 [OneScreen, Sectra]; Bach-Mortensen, et al., 2006 [X-posure System™ Sectra Pronosco A/S]. Professional Societies/Organizations: The BHOF Clinician’s Guide to Prevention and Treatment of Osteoporosis (LeBoff, et al., 2022) states vertebral fracture imaging (X-ray or DXA vertebral fracture assessment) should be performed in high risk individuals to detect subclinical vertebral fractures. Traditionally, conventional lateral thoracic/lumbar spine X-ray has been considered the gold standard for identification of vertebral fractures and minor vertebral deformities. However, DXA-assisted vertebral fracture assessment (DXA- VFA) is emerging as an alternative to radiography for its convenience, low cost, and minimal radiation exposure. Recently performed MRI or CT imaging studies done for other purposes can and should also be evaluated for presence of vertebral fractures or evidence of vertebral deformity. The BHOF Clinician’s Guide to Prevention and Treatment of Osteoporosis (LeBoff, et al., 2022) does not address the use of digital X-ray radiogrammetry (DXR) to estimate hand BMD. The American College of Radiology (ACR) Appropriateness Criteria® Osteoporosis and Bone Mineral Density (2022) section titled ‘Radiography Axial Skeleton’, states that there is insufficient evidence to support the current use of radiography as a screening tool in patients suspected of having osteoporosis or low BMD. Patients who have radiographic evidence of demineralization and/or fragility fractures should be referred to DXA for further characterization. The AACE 2020 Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis (Camacho, et al., 2020) does not address use of diagnostic CT scans or hand x-rays. National Institute for Health and Care Excellence (NICE) published a Medtech Innovation Briefing July 2021 on HealthVCF for detecting vertebral compression fractures on CT scans. In summary, the NICE overall assessment of the evidence noted there is limited evidence on HealthVCF for detecting spinal bone fractures on CT scans. The evidence base would benefit from further evidence using prospective data collection to fully establish the real-world clinical performance of the HealthVCF artificial intelligence (AI) algorithm. Ideally this evidence would be UK-based. Also, studies evaluating the effect of using the technology on patient outcomes and changes in clinical management would be useful, such as referrals to osteoporotic care. Pulse-echo Ultrasound (CPT® 0508T) The Bindex BI-100 device (Bindex® Osteoporosis Measurement, Bone Index Ltd., Finland) received FDA 510(k) approval on May 13, 2016 (K152020). The Bindex® BI-2 device (Bone Index Ltd., Finland) received FDA 510(k) approval on January 9, 2017 (K161971). According to the FDA, Bindex® measures apparent cortical bone thickness at the proximal tibia and can be used in conjunction with other clinical risk factors or patient characteristics as an aid to the physician in the diagnosis of osteoporosis and other medical conditions leading to reduced bone strength and in the determination of fracture risk. The Bindex system includes ultrasound pulser, transducer and software. Bindex is connected to the USB port of a computer and controlled with computer software. Bindex is used for measurement of cortical bone thickness and it provides Density Index (DI), a parameter which estimates bone mineral density at the hip as measured with DXA. Published articles suggest pulse-echo ultrasound Density Index (DI) algorithm be used in conjunction with established fracture risk assessment tools (for example, FRAX) to aid in determining whether referral for DXA scan is appropriate. The peer-reviewed scientific literature lacks well-designed studies evaluating the impact of utilizing Bindex® on long-term health outcomes (Lewiecki, 2020; Karjalainen, et al., 2018; Schousboe, et al., 2017). The Endocrine Society does not address measurement of cortical bone thickness in these guidelines: Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society Clinical Practice Guideline (Eastell, et al., 2019) Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society Guideline Update (Shoback, et al., 2020) Medical Coverage Policy: 0300 The American Association of Clinical Endocrinologists (AACE) states For BMD measurement, several other techniques are available, including quantitative computed tomography for measurement of both central and peripheral sites, quantitative ultrasonometry, radiographic absorptiometry, and single-energy X-ray absorptiometry. The AACE also notes that peripheral bone density measurements can identify patients at increased risk for fracture; however, the diagnostic DXA criteria established by the WHO and recommended by AACE apply only to the axial measurements (i.e., lumbar spine, femoral neck, and total hip) and distal 1/3 of the radius. Thus, other technologies should not be used to diagnose osteoporosis but may be used to assess fracture risk (Camacho, et al., 2020). The American College of Radiology (ACR) Appropriateness Criteria® for Osteoporosis and Bone Mineral Density (2016) address various testing modalities in the scenario of asymptomatic BMD screening or screening individuals with established or clinically suspected low BMD (e.g., older women). The ACR noted that although peripheral ultrasound (QUS) represents a low-cost alternative easily accessible to primary care providers, the heel represents the only validated site for the clinical use of QUS. Trabecular Bone Score (TBS) (CPT® 77089 – 77092) In 2012, TBS (TBS iNsight®; Med-Imaps, Pessac, France) was approved by the US Food and Drug Administration for use as a complement to DXA analysis for the assessment of fracture risk. The Indications for use read as follows: The Med-Imaps TBS iNsight is a software provided for use as a complement to a DEXA analysis. It computes the antero-posterior spine DEXA examination file and calculates a score (Trabecular Bone Score - TBS) that is compared to those of the age-matched controls. The TBS is derived from the texture of the DEXA image and has been shown to be related to bone microarchitecture and fracture risk. This data provides information independent of BMD value;' it is used as a complement to the data obtained from the DEXA analysis and the clinical examination (questioning by the clinician about patient history, bioassay of bone resorption markers... ). The TBS score can assist the health care professional in assessment of fracture risk and in monitoring the effect of treatments on patients across time. Overall fracture risk will depend on many additional factors that should be considered before making diagnostic or therapeutic recommendations. The software does not diagnose disease, or recommend treatment regimens. Only the health care professional can make these judgments (K121716; October 5, 2012). An update, K152299 (April 29, 2016) states the following Indications for Use: TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical examination. It computes the antero-posterior spine DXA examination file and calculates a score (Trabecular Bone Score - TBS) that is compared to those of the age matched controls. The TBS is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture. TBS iNsight provides as an option an assessment of 10-year fracture risk. It provides an estimate of 10- year probability of hip fracture and 10-year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture). This estimate is based on the WHO’s FRAX® Fracture Risk Assessment Tool, after adjustment for the TBS. The tool has been validated for Caucasian and Asian men and post-menopausal women between 40 and 90 years old. TBS provides information independent of BMD value; it is used as a complement to the data obtained from the DXA analysis and the clinical examination (questioning by the clinician about patient history, bioassay of bone resorption markers). The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and other medical conditions leading to altered trabecular bone microarchitecture, and ultimately in the assessment of fracture risk. The TBS score can assist the health care professional in monitoring the effect of treatments on patients across time. Overall fracture risk will depend on many additional factors that should be considered before making diagnostic or therapeutic recommendations. The software does not diagnose disease, or recommend treatment regimens. Only the health care professional can make these judgments (K152299; April 29, 2016). There is a lack of well-designed clinical trials including diverse populations in the peer-reviewed scientific literature addressing the impact of TBS iNsight® (Med-Imaps) on patient-specific health outcomes. Future prospective trials evaluating the use trabecular bone score in place of or in addition to established fracture Medical Coverage Policy: 0300 prediction tools should report if long-term patient health outcomes are improved (McCloskey, et al., 2015; Leslie, et al., 2014; Hans, et al., 2011). American Association of Clinical Endocrinologists (AACE): The AACE and American College of Endocrinology (ACE) Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis (Camacho, et. al., 2020) states: R22: Pharmacologic therapy is strongly recommended for patients with a T-score between −1.0 and −2.5 if the FRAX® (fracture risk assessment tool) (or if available, trabecular bone score [TBS]-adjusted FRAX®) 10-year probability for major osteoporotic fracture is ≥20% or the 10-year probability of hip fracture is ≥3% in the U.S. or above the country-specific threshold in other countries or regions (Grade A) Role of Trabecular Bone Score in Adjusting FRAX® Risk High TBS values (note that TBS is unitless) correlate with homogeneous (i.e., normal) bone texture, while low values are indicative of more variable (i.e., weaker) bone texture. Numerous studies have shown that TBS predicts fracture risk independent of BMD and that it enhances fracture risk prediction capabilities of FRAX®. Low TBS values increase FRAX® estimated risk, while high TBS values reduce it. TBS adjustment of FRAX® has been validated in 14 prospective international cohorts. The Endocrine Society does not address TBS in these guidelines: Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society Clinical Practice Guideline (Eastell, et al., 2019) Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society Guideline Update (Shoback, et al., 2020) Use Outside of the US International Society for Clinical Densitometry (ISCD): The ISCD Official Adult Position (2019) indications for BMD Testing: Women aged 65 and older • For post-menopausal women younger than age 65 a bone density test is indicated if they have a risk factor for low bone mass such as;  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 body weight, prior fracture, or high-risk medication use. Men aged 70 and older. • For men < 70 years of age a bone density test is indicated if they have a risk factor for low bone mass such as;  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. • Adults taking medications associated with low bone mass or bone loss. • Anyone being considered for pharmacologic therapy. • Anyone being treated, to monitor treatment effect. • Anyone not receiving therapy in who evidence of bone loss would lead to treatment. Note: Women discontinuing estrogen should be considered for bone density testing according to the indications listed above. Medical Coverage Policy: 0300 Under 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. Under Vertebral Fracture Assessment Nomenclature Vertebral Fracture Assessment (VFA) is the correct term to denote densitometric spine imaging performed for the purpose of detecting vertebral fractures. Under Indications for VFA Lateral Spine imaging with Standard Radiography or Densitometric VFA is indicated when T-score is < - 1.0 and of one or more of the following is present:  Women age ≥ 70 years or men ≥ age 80 years  Historical height loss > 4 cm (>1.5 inches)  Self-reported but undocumented prior vertebral fracture  Glucocorticoid therapy equivalent to ≥ 5 mg of prednisone or equivalent per day for ≥ 3 months Under QCT and pQCT Finite Element Analysis (FEA): Vertebral strength as estimated by QCTbased FEA predicts vertebral fracture in postmenopausal women. Vertebral strength as estimated by QCTbased FEA is comparable to spine DXA for prediction of vertebral fractures in older men. Femoral strength as estimated by QCT-based FEA is comparable to hip DXA for prediction of hip fractures in postmenopausal women and older men. FEA cannot be used to diagnose osteoporosis using the current WHO T-score definition. • Vertebral or femoral strength as estimated by QCT-based FEA can be used to initiate pharmacologic treatment using validated thresholds and in conjunction with clinical risk factors. Vertebral or femoral strength as estimated by QCT-based FEA can be used to monitor age- and treatment-related changes. Under Trabecular Bone Score (TBS) TBS is associated with vertebral, hip and major osteoporotic fracture risk in postmenopausal women. • TBS is associated with hip fracture risk in men over the age of 50 years. • TBS is associated with major osteoporotic fracture risk in men over the age of 50 years. • TBS should not be used alone to determine treatment recommendations in clinical practice. • TBS can be used in association with FRAX and BMD to adjust FRAX-probability of fracture in postmenopausal women and older men. In patients receiving anti-fracture therapy:  The role of TBS in monitoring antiresorptive therapy is unclear.  TBS is potentially useful for monitoring anabolic therapy. TBS is associated with major osteoporotic fracture risk in postmenopausal women with type II diabetes. Under Peri-prosthetic and Orthopedic Uses of DXA Elective orthopedic and spine surgery patients with the following conditions are at greater risk for impaired bone health and should have DXA testing: Diabetes mellitus (long term duration of diabetes (>10yrs) and poor control): Trabecular bone score (TBS) measurement should be obtained in patients with diabetes, if available.