Medical Policy: 06.01.30 

Original Effective Date: August 2013 

Reviewed: April 2021 

Revised: April 2016 

 

Notice:

This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

This Medical Policy 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 will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

Osteoporosis, defined as low bone mass leading to an increased risk of fragility fractures, is an extremely common disease in the elderly due to age-related bone loss in both sexes and menopause-related bone loss in geno typical women.

 

According to the WHO (World Health Organization) diagnostic classification, osteoporosis is defined by bone mineral density (BMD) at the hip or lumbar spine that is less than or equal to 2.5 standard deviations below the mean BMD of a young adult.

 

The diagnosis of osteoporosis is established by measurement of bone mineral density (BMD). Bone mineral density can be measured with a variety of techniques (DXA/DEXA, CT based absorptiometry or ultrasound) in a variety of sites. Sites are broadly subdivided into central sites (i.e., hip or spine) and peripheral (i.e., wrist, finger, heel). The technique most commonly used to measure BMD is dual x-ray absorptiometry (DXA/DEXA).

 

Quantitative Ultrasound Densitometry (QUS)

Quantitative ultrasonography scanning measures bone mass and strength and assesses bone microarchitecture by detecting the transmission of high-frequency sound waves through bone. QUS results are reported as broadband ultrasound attenuation (BUA) and the speed of sound (SOS). These two parameters are sometimes combined to yield a “stiffness index”. QUS is a technique for measuring bone mass at peripheral sites such as heel, tibia and phalanges. It does not use ionizing radiation and has the advantage of being small, portable and relatively inexpensive. However, this technique has not been shown to be useful in monitoring skeletal response to different therapies used to treat osteoporosis. Therefore, this technology is considered investigational.

 

Vertebral Fracture Assessment using Dual X-ray Absorptiometry (DXA/DEXA)

Vertebral fractures are highly prevalent in the elderly population. Most vertebral fractures are asymptomatic when they first occur and often go undiagnosed for many years. Only 20-30% of vertebral fractures are recognized clinically, the rest are discovered incidentally on lateral spine radiographs.

 

The newest generation of fan beam DXA systems delivering “high-resolution” lateral spine images offers a potential practical alternative to radiographs for clinical vertebral fracture analysis. The advantages of using DXA over conventional radiographic devices are its minimal radiation exposure and high speed image acquisition. It also allows combined evaluation of vertebral fracture status and bone mass density, which could become a standard for patient evaluation of osteoporosis. However, the disadvantage of DXA use is the upper thoracic vertebrae cannot be evaluated in a substantial number of patients due to poor imaging quality. The clinical utility using dual x-ray absorptiometry (DXA/DEXA) for evaluation of vertebral fractures may help in screening patients, but technological improvements are necessary to improve image quality.

 

Studies comparing DXA/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. 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 decreased bone mineral density (BMD). At this time, there is no clear guidance for the treatment of asymptomatic vertebral fracture in geno typical women with normal BMD. It is not known whether anti-resorptive therapy would improve the fracture risk in individuals with normal or near normal bone mineral density. There is insufficient evidence in the published peer reviewed scientific literature regarding the clinical utility using dual x-ray absorptiometry (DXA/DEXA) for evaluation of vertebral fractures. This technique may help in screening patients, but technological improvements are necessary to improve image quality. Also, there is insufficient evidence on health outcomes as there are no clear guidance for the treatment of asymptomatic vertebral fractures with normal BMD and whether or not anti-resorptive therapy would improve the fracture risk in individuals with normal or near normal bone mineral density. Therefore, screening for vertebral fracture assessment using dual x-ray absorptiometry as an adjunct to bone mineral density measurement is considered investigational.

 

Practice Guidelines and Position Statements

American College of Radiology (ACR)

American College of Radiology (ACR) – Society of Skeletal Radiology (SSR) Practice Guideline for the Performance of Dual Energy X-ray Absorptiometry (DXA)

 

Summary of Recommendations:

  • BMD measurement is used to identify patients with low bone density and increased fracture risk.
  • DXA is the gold standard and the only BMD technology for which WHO (World Health Organization) criteria is based on for diagnosis of osteoporosis.
  • The sites that are used for diagnosis are the AP spine, femoral neck. 

 

Follow up treatment can be performed using DXA (dual x-ray absorptiometry) and QCT (quantitative computed tomography) only.

 

U.S. Preventative Services Task Force

The U.S. Preventive Services Task Force (2018) updated its recommendations on screening for osteoporosis to prevent fractures. The recommendations included: “Most treatment guidelines recommend using BMD, as measured by central DXA, to define osteoporosis and the treatment threshold to prevent osteoporotic fractures.” Peripheral DXA and quantitative ultrasound are also described as common bone measurement screening tests for osteoporosis. VFA was not specifically mentioned.

 

American College of Physicians

The American College of Physicians’ guidelines (2017) on the treatment of low bone density or osteoporosis include the following recommendations:

 

Recommendation Grade of Evidence Quality of Evidence
American College of Physicians recommends that clinicians offer pharmacologic treatment with bisphosphonates to reduce the risk for vertebral fracture in men who have clinically recognized osteoporosis.” Weak Low
American College of Physicians recommends that clinicians should make the decision whether to treat osteopenic women 65 years of age or older who are at a high risk for fracture based on a discussion of patient preferences, fracture risk profile, and benefits, harms, and costs of medications.” Weak Low

ACP: American College of Physicians; GOE: grade of evidence; QOE: quality of evidence.

 

Regulatory Status


Vertebral fracture assessment application packages that have received 510(k) marketing clearance are the Instant Vertebral Assessment (IVA) (Hologic, Inc.) GEHC DXA Bone Densitometers with enCORE version 18 (GE) and Dual Energy Vertebral Assessment (DVA) (previously known as Lateral Vertebral Assessment (LVA) (GE Lunar Medical Systems). 

 

Prior Approval:

Not applicable.

 

Policy:

Screening for vertebral fractures using dual x-ray absorptiometry (DXA or DEXA) as an adjunct to bone mineral density measurement is considered investigational.

 

There is insufficient evidence in the published peer reviewed scientific literature regarding the clinical utility using dual x-ray absorptiometry (DXA/DEXA) for evaluation of vertebral fractures. This technique may help in screening patients, but technological improvements are necessary to improve image quality. Also, there is insufficient evidence on health outcomes as there are no clear guidance for the treatment of asymptomatic vertebral fractures with normal BMD and whether or not anti-resorptive therapy would improve the fracture risk in individuals with normal or near normal bone mineral density. Therefore, screening for vertebral fracture assessment using dual x-ray absorptiometry as an adjunct to bone mineral density measurement is considered investigational. If a vertebral fracture is identified in an asymptomatic individual, studies do not report the impact of that finding on long-term health outcomes.

 

Several recent studies have compared the diagnostic accuracy of vertebral fracture assessment (VFA) and standard radiography. None of these reported findings separately for osteoporotic and non-osteoporotic patients, so conclusions cannot be drawn about diagnostic accuracy of VFA in patients without osteoporosis. Moreover, studies tended to use radiography as the reference standard and did not evaluate potential false positives or false negatives associated with radiography. There is a lack of direct evidence from screening trials that use densitometry with and without VFA that improves health outcomes.

 

The use of quantitative ultrasound densitometry (QUS) to measure bone mineral density (BMD) is considered investigational for all applications.

 

QUS is a technique for measuring bone mass at peripheral sites such as heel, tibia and phalanges. QUS results are reported as broadband ultrasound attenuation (BUA) and the speed of sound (SOS). This technique has not been shown to be useful in monitoring skeletal response to different therapies used to treat osteoporosis. Therefore, this technology is considered investigational. Also, current diagnostic and treatment criteria for osteoporosis rely on DXA (dual x-ray absorptiometry) measurements only.

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.

  • 77085 Axial skeleton (e.g., hips, pelvis, spine), including vertebral fracture assessment
  • 77086 Vertebral fracture assessment via dual energy X-ray absorptiometry (DXA)
  • 76977 Ultrasound bone density measurement and interpretation, peripheral site

 

Selected References:

  • National Osteoporosis Foundation, 2013 Clinician's Guide to Prevention and Treatment of Osteoporosis.
  • ACR-SPR-SSR Practice Guideline for the Performance of Dual Energy X-Ray Absorptiometry (DXA), Revised 2013.
  • The International Society for Clinical Densitometry, Official Positions, Uupdated August 15 2013: Indications for Bone Mineral Density (BMD) Testing.
  • Medscape: Diagnosis of Osteoporotic Vertebral Fractures: Importance of Recognition and Description by Radiologists; Leon Lenchik, Lee F. Rogers, Pierre D. Delmas, Harry K. Genant; Am J Roentgenol 2004; 183(4)
  • Clinical review: Clinical Applications of Vertebral Fracture assessment by Dual Energy X-ray Absorpitometry; J Clin Endocrinol Metab 2006 Nov, 91(11):4215-22. Epub 2006 Aug 29
  • Risedronate Decreases Fracture Risk in Patients Selected Solely on the Basis of Prior Vertebral Fracture, J.A.Kanis, P. Barton, O. Johnell. Osteoporosis International May 2005, Volume 16, Issue 5, pp 475-482
  • ECRI Health Technology Assessment Information Service: Ultrasound Bone Densitometry for Diagnosis of Osteoporosis
  • Drake MT, Murad MH, Mauc, KF, Lane MA, et al. Clinical review. Risk factors for low bone mass-related fractures in men: a systematic review and meta-analysis. J Clin Endocrinol Metab. 2012 Jun;97(6):1861-70.
  • Bradford J, Richmond JB, Dalinka MK et al. Expert Panel on Musculoskeletal Imaging. American College of radiology ACR Appropriateness Criteria™: Osteoporosis and bone mineral density. Last review date: 2007. 
  • Aubry-Rozier B, Hans D, Krieg MA, et al. Morphometric vertebral assessments via the use of dual X-ray absorptiometry for the evaluation of radiographic damage in ankylosing spondylitis: A pilot study. J Clin Densitom. 2014;17(1):190-194.
  • Marín F, López-Bastida J, Díez-Pérez A, et al. Bone mineral density referral for dual-energy X-ray absorptiometry using quantitative ultrasound as a prescreening tool in postmenopausal women from the general population: a cost-effectiveness analysis. Calcif Tissue Int 2004; 74:277.
  • National Osteoporosis Foundation, The Clinician's Guide to Prevention and Treatment of Osteoporosis 2013.
  • Kanterewicz E, Puigoriol E, Garcia-Barrionuevo J et al. Prevalence of vertebral fractures and minor vertebral deformities evaluated by DXA-assisted vertebral fracture assessment (VFA) in a population-based study of postmenopausal women: the FRODOS study. Osteoporos Int. 2014; 25(5):1455-64.
  • Lee, J., Lee, Y., Oh, S. et al. A systematic review of diagnostic accuracy of vertebral fracture assessment (VFA) in postmenopausal women and elderly men. Osteoporos Int. 2016 May;27(5):1691-9. doi: 10.1007/s00198-015-3436-z. Epub 2016 Jan 18.
  • Qaseem A, Forciea MA, McLean RM, et al.(2017) Treatment of low bone density or osteoporosis to prevent fractures in men and women: a clinical practice guideline update from the American College of Physicians. Ann Intern Med. Jun 06 2017;166(11):818-839. PMID 28492856
  • Malgo, F. et al. “Value and Potential Limitations of Vertebral Fracture Assessment (VFA) Compared to Conventional Spine Radiography: Experience from a Fracture Liaison Service (FLS) and a Meta-Analysis.” Osteoporosis International 28.10 (2017): 2955–2965. PMC. Web. 17 Apr. 2018.
  • U. S. Preventive Services Task Force, Curry SJ, Krist AH, et al. Screening for osteoporosis to prevent fractures: US Preventive Services Task Force Recommendation Statement. JAMA. Jun 26 2018;319(24):2521-2531. PMID 29946735
  • U.S. Preventive Services Task Force. Osteoporosis to Prevent Fractures: Screening. 2018
  • Kunitoki K, Mutoh T, Tatewaki Y, et al. Clinical Utility of a Semiquantitative Method Using Lumbar Radiography as a Screening Tool for Osteoporosis in Elderly Subjects. Med Sci Monit. 2019;25:6928–6934. Published 2019 Sep 14. doi:10.12659/MSM.917035
  • Yang J, Mao Y, Nieves JW. Identification of prevalent vertebral fractures using Vertebral Fracture Assessment (VFA) in asymptomatic postmenopausal women: A systematic review and meta-analysis. Bone. Jul 2020; 136: 115358. PMID 32268210
  • Camacho PM, Petak SM, Binkley N, et al. American Association of Clinical Endocrinologists/American College of Endocrinology clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis -2020 Update. Endocr Pract. May 2020; 26(Suppl 1): 1-46. PMID 32427503

 

Policy History:

  • April 2021 - Annual Review, Policy Renewed
  • April 2020 - Annual Review, Policy Renewed
  • April 2019 - Annual Review, Policy Renewed
  • April 2018 - Annual Review, Policy Renewed
  • April 2017 - Annual Review, Policy Renewed
  • April 2016 - Annual Review, Policy Revised
  • May 2015 - Annual Review, Policy Renewed
  • June 2014 - Annual Review, Policy Revised
  • August 2013 - New policy

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.