Clinical UM Guideline
|Subject:||Central (Hip or Spine) Bone Density Measurement and Screening for Vertebral Fractures Using Dual Energy X-Ray Absorptiometry|
|Guideline #:||CG-MED-39||Current Effective Date:||01/14/2014|
|Status:||Reviewed||Last Review Date:||11/14/2013|
Bone mineral density (BMD) measurement is a non-invasive technique that is used to measure bone mineral content and bone mineral density. Its primary role is to detect osteoporosis and to predict the risk of fractures. Dual-energy absorptiometry (DEXA) is the most commonly used technique to measure BMD. Lateral spine images can also be obtained using DEXA, and thus is it possible to screen for vertebral fractures at the same time a subject is undergoing assessment of BMD. This guideline addresses central BMD measurements and vertebral fracture assessment using dual energy X-Ray absorptiometry.
For information regarding peripheral (e.g. forearm, finger, and heel) bone density studies including the use of heel densitometry, peripheral dual energy x-ray absorptiometry (pDEXA), radiographic absorptiometry of the fingers, single energy X-ray absorptiometry (SEXA), single photon absorptiometry (SPA), and dual X-ray and laser (DXL), please refer to RAD.00004 – Peripheral Bone Mineral Density Measurement.
This document does not address bone density testing by computed tomography.
INITIAL CENTRAL BONE MINERAL DENSITY MEASUREMENTS
In general, a baseline central bone mineral density (BMD) measurement may be considered medically necessary whenever there is a reasonable expectation that the findings will be abnormal and a treatment decision may be influenced by the outcome of the test.
Specifically, an initial (baseline) central (hip or spine) bone density measurement is considered medically necessary when performed in any of the following settings:
REPEAT CENTRAL BONE MINERAL DENSITY MEASUREMENTS
Individuals Not On Therapy Related To Osteoporosis:
Individuals On Therapy Related To Osteoporosis:
Repeat measurements of BMD as a technique to monitor response to therapy for osteoporosis are considered medically necessary when performed at intervals of 2 years or greater.
CENTRAL BONE DENSITY MEASUREMENTS for Asymptomatic Hyperparathyroidism
Bone density measurement using the spine (trabecular bone), or hip (mixed cortical and trabecular bone) is considered medically necessary when performed for individuals (male or female) with asymptomatic primary hyperparathyroidism (PHPT) where consideration for surgery is in large part determined by bone density level.
Not Medically Necessary:
CENTRAL BONE DENSITY MEASUREMENTS
Central bone density measurement is considered not medically necessary in any of the following circumstances:
VERTEBRAL FRACTURES USING DUAL X-RAY ABSORPTIOMETRY
Screening for vertebral fractures using dual x-ray absorptiometry as an adjunct to bone mineral density measurement is considered not medically necessary.
The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
|77080||Dual-energy X-ray absorptiometry (DXA), bone density study, 1 or more sites; axial skeleton (e.g., hips, pelvis, spine)|
|77082||Dual-energy X-ray absorptiometry (DXA), bone density study, 1 or more sites; vertebral fracture assessment|
|78351||Bone density (bone mineral content) study, 1 or more sites; dual photon absorptiometry, 1 or more sites [DPA]|
|ICD-9 Diagnosis||[For dates of service prior to 10/01/2014]|
|ICD-10 Diagnosis||[For dates of service on or after 10/01/2014]|
Description of Disease
Osteoporosis is characterized by slow, prolonged bone loss. The National Osteoporosis Foundation in 2013 noted that in the United States, 10 million individuals are estimated to have osteoporosis. In addition, 33.6 million Americans have low bone density of the hip. Approximately one out of every two Caucasian women will experience an osteoporosis-related fracture at some point in her lifetime, as will approximately one in five men. While osteoporosis occurs less frequently in African Americans, those with osteoporosis have the same elevated fracture risk as Caucasians. The incidence of osteoporosis in the U.S. is expected to increase significantly in the future as the population ages (NOF, 2013).
Treatment of Disease
The goal of osteoporosis treatment is to prevent or decrease the rate of bone loss. Such treatment may include, but is not necessarily limited to calcium and vitamin supplementations, exercise and medications such as calcitonin, parathyroid hormone, estrogens, bisphosphonates (alendronate, ibandronate and risedronate), and raloxifene.
Treatment planning represents a joint decision by the individual and their treating physician following discussion of the potential risks and benefits of therapy.
Description of Technology
Bone densitometry is a non-invasive technique that is used to measure bone mineral content in order to predict fracture risks and the need for medical therapy. BMD can be measured at several anatomical locations. Peripheral BMD are generally determined by obtaining measurements at the wrist, forearm, finger or heel, while central BMD measurements are obtained by obtaining measurements from the hip or spine. BMD is typically expressed as the T-score (e.g., the number of standard deviations [SD] below the mean for non-osteopenic, healthy, young women). The World Health Organization defines osteopenia as a T-score of between –1.0 and -2.5 SD, and osteoporosis as a score of –2.5 SD or more.
Initial and Repeat Bone Mineral Density Measurements
There is adequate evidence to support the use of central bone density studies to assess the risk of osteoporosis in settings where the results may influence medical therapy. Studies have demonstrated the efficacy of bone mineral studies for several populations at higher risk for this process, including postmenopausal women, especially those over the age of 65, individuals currently receiving medications for osteoporosis prophylaxis, those receiving glucocorticoid therapy and individuals with endocrinopathies or other conditions which predispose to osteoporosis. Examples of these include: hyperthyroidism and hypothyroidism, hyperparathyroidism, corticosteroid use, and rheumatoid arthritis. Currently both the American Association of Clinical Endocrinologist (AACE) Medical Guidelines for Clinical Practice for the Prevention and Treatment of Postmenopausal Osteoporosis (2001 edition, with selected updates for 2003) and the U.S. Preventative Services Task Force statement on Screening for Osteoporosis in Postmenopausal Women (2002) recommend a screening BMD scan for all women over the age of 65 (USPHTF B recommendation). The American College of Obstetricians and Gynecologists (ACOG) recommends screening for all postmenopausal women who have sustained a fracture and for all postmenopausal women with any of a broadly defined set of risk factors (ACOG, 2012).
The timing of additional studies after the initial screening is a topic of discussion. According to ACOG, after treatment has been initiated, one DXA scan 1 – 2 years later can be used to assess the effect of treatment. If the BMD is improved or stable (no significant change), and there are no new risk factors, the DXA does not usually need to be repeated (ACOG, 2012). This is based upon the results of several trials that evaluated the change in BMD in individuals undergoing therapy for various conditions. These studies found that change in bone density could not be meaningfully assessed until late in the second year of therapy because some individuals actually continue to lose bone density during the first year but have subsequent significant increases during the second year of therapy. Alternatively, the AACE notes that until evidence-based specific data is available for BMD monitoring, they recommend bone density studies for individuals undergoing osteoporosis prevention, every 1 to 2 years until bone mass is stable, then every 2-3 years after stabilization. In addition, the AACE recommends when monitoring therapy, bone studies be done yearly for two years, and if bone mass is stabilized then every 2 years thereafter, if not stabilized, then yearly until bone mass is stabilized.
Gourlay and colleagues (2012) conducted a multicenter prospective study to examine data on the optimal bone density screening interval in a large cohort of women with normal BMD or osteopenia at initial screening. The participants included 4957 women, 67 years of age or older, with normal BMD or osteopenia and with no history of hip or clinical vertebral fracture or of treatment for osteoporosis, followed prospectively for up to 15 years. The BMD testing interval was defined as the estimated time for 10% of the participants to make the transition to osteoporosis before having a hip or clinical vertebral fracture, with adjustment for clinical risk factors and estrogen use. The researchers found that it would take approximately 17 years for 10% of women with normal BMD or mild osteopenia to transition to osteoporosis before having a hip or vertebral fracture, approximately 5 years for those with moderate osteopenia to transition to osteoporosis, and 1 year for those with advanced osteopenia. .At the time of this review, the results of this study had not been incorporated into national osteoporosis screening recommendations.
Screening for Vertebral Fractures Using DEXA
Studies have investigated the use of DEXA as a screening tool for vertebral fractures as an adjunct to BMD measurements in asymptomatic individuals. These studies have reported that asymptomatic vertebral fractures may be present in up to 20% of postmenopausal women who have normal BMD measurements. However, it is not known whether any specific therapy, i.e., bisphosphonate therapy, will reduce fracture risk in these individuals with normal bone mass.
Studies comparing DEXA vertebral fracture assessment to lateral spine X-rays (considered the "gold standard" for diagnosis of vertebral fractures) have shown high levels of agreement between the two techniques. If this were the only issue, there would be little debate as to the suitability of using DEXA for this purpose. However, one basic principle of screening is that there must be clear treatment guidelines demonstrating improvement in health outcomes related to treatment of an asymptomatic condition. Currently treatment of osteoporosis is based on the presence of a decreased BMD. At this time, there is no clear guidance for the treatment of an asymptomatic vertebral fracture in women with a normal BMD. For example, it is not known whether anti-resorptive therapy would improve the fracture risk in individuals with normal or near-normal BMD.
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
Bone Mineral Density (BMD) Measurement
DEXA, Screening for Vertebral Fractures Using
Dual X-Ray Absorptiometry, Screening for Vertebral Fractures Using
Fractures (Vertebral), Screening for Using Dual X-Ray Absorptiometry
Instant Vertebral Assessment (IVA)
Lateral Vertebral Assessment (LVA)
Screening for Vertebral Fractures Using Dual X-Ray Absorptiometry
Vertebral Fractures, Screening for Using Dual X-Ray Absorptiometry
|Reviewed||11/14/2013||Medical Policy & Technology Assessment Committee (MPTAC) review. Updated review date, Rationale, References and History sections of document.|
|Reviewed||11/08/2012||MPTAC review. Updated review date, Rationale, Discussion/General Information and History sections of document.|
|Reviewed||11/17/2011||MPTAC review. Updated review date, References and History sections of document.|
|Reviewed||11/18/2010||MPTAC review. Updated review date, References and History sections of document.|
|10/14/2010||Category number changed from CG-RAD-18 to CG-MED-39. Removed CPT code 77078 from the Coding section of document. Updated Website information.|
|Reviewed||11/19/2009||MPTAC review. Removed "Place of Service/Duration" section. Updated the review date, Discussion/ General Information, references and history sections.|
|06/04/2009||Removed the passage addressing the "Interventional Society of Clinical Densitometry" from the discussion/general information section of the document.|
|Revised||11/20/2008||MPTAC review. Document revised to address screening of vertebral fractures using DEXA which is considered not medically necessary. Osteogenesis imperfecta and inflammatory bowel disease added to conditions which may contribute to the development of osteoporosis. Title changed to Central (Hip or Spine) Bone Density Measurement and Screening for Vertebral Fractures Using Dual Energy X-Ray Absorptiometry. Updated Discussion/General Information, References, Coding and History sections.|
|Reviewed||11/29/2007||MPTAC review. Updated review date, discussion/general information, references and history sections. No change in patient selection criteria.|
|Revised||08/23/2007||MPTAC review. Modified language in the "Repeat BMD Measurements" section to clarify that all individuals listed in bullet #3 are considered at high risk for osteoporosis. Under the NMN section, deleted the words "or cardiac prophylaxis from bullet #2. Updated the discussion/general information, place of service, references and history sections.|
|New||12/07/2006||MPTAC initial guideline development. Guideline addresses central bone density measurements. Peripheral bone density measurement and screening of vertebral fractures using DEXA are now addressed in RAD.00004 – Peripheral Bone Mineral Density Measurement and Screening for Vertebral Fractures Using DEXA.|