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Vertebral Fracture Assessment with Dual X-Ray Absorptiometry (DEXA)

Policy Number: MP-202

Latest Review Date: September 2021

Category:  Radiology                                                             

Policy Grade: D

POLICY:

Screening for vertebral fractures using dual x-ray absorptiometry (DEXA or DXA) or morphometric absorptiometry (MXA) is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Vertebral fracture assessment (VFA) with densitometry is a technique to assess vertebral fractures at the same time as bone mineral density, using additional software with dual-energy x-ray absorptiometry. The addition of VFA to bone mineral density may augment diagnostic information on fracture risk.

Diagnosis

Only 20-30% of vertebral fractures are recognized clinically and the rest are discovered incidentally on lateral spine radiographs. Lateral spine radiographs have not been recommended as a component of risk assessment for osteoporosis, because of the cost, radiation exposure and the fact that the x-ray would require a separate procedure in addition to the bone mineral density study using dual x-ray absorptiometry (DXA). However, several densitometers with specialized software are able to perform vertebral fractures assessment (VFA) in conjunction with DXA. The lateral spine scan is performed by using a rotating arm; depending on the densitometer used, the patient can either stay in the supine position after the bone density study or is required to move onto the left decubitus position.

VFA differs from radiologic detection of fractures, as VFA uses a lower radiation exposure and can detect only fractures, while traditional radiograph images can detect other bone and soft tissue abnormalities in addition to spinal fractures. Manufacturers have also referred to this procedure as instant vertebral assessment (IVA), radiographic vertebral assessment (RVA), dual energy vertebral assessment (DVA), or lateral vertebral assessment (LVA).

For both lateral spine radiographs and images with densitometry, vertebral fractures are assessed visually. While a number of grading systems have been proposed, the semiquantitative system of Genant is commonly used. This system grades the deformities from I to III, with Grade I (mild) representing a 20-24% reduction in vertebral height, Grade II (moderate) representing a 25% to 39% reduction in height, and Grade III (severe) representing a 40% or greater reduction in height. The location of the deformity within the vertebrae may also be noted. For example, if only the mid height of the vertebrae is affected, the wedge deformity is defined as an endplate deformity, if both the anterior and mid heights are deformed, it is a wedge deformity and if the entire vertebrae is deformed it is classed as a crush deformity. A vertebral deformity of at least 20% loss in height is typically considered a fracture. Accurate interpretation of both lateral spine x-rays and VFA imaging is dependent on radiologic training. Thus, device location and availability of appropriately trained personnel may influence diagnostic accuracy.

For additional information regarding bone mineral density (BMD) as a screening for osteoporosis see medical policy #191- Bone Mineral Density Testing.

KEY POINTS:

The most recent literature review was updated through July 29, 2021.

Summary of Evidence

For individuals who are at risk of having vertebral fractures but are not known to have them who receive VFA with densitometry by dual-energy x-ray absorptiometry, the evidence includes diagnostic accuracy studies and subgroup reanalyses of treatment studies. Relevant outcomes are test accuracy, test validity, and morbid events. There is a lack of direct evidence from screening trials that use densitometry with VFA improves health outcomes. Because direct evidence was not available, a chain of evidence was sought. Evidence was examined on the diagnostic accuracy of VFA in nonosteoporotic patients (i.e., those not already eligible for treatment), the ability of VFA to identify patients for treatment who would not otherwise be identified, and the effectiveness of treatment in this population. Diagnostic accuracy studies have reported variable findings; recent studies have suggested higher diagnostic accuracy of VFA overall compared with standard radiographs than older studies. Studies have found that VFA can identify patients without osteoporosis who may be appropriate candidates for treatment according to recommendations from the National Osteoporosis Foundation. However, there is limited evidence on the effectiveness of treatment in this population. No treatment data have been published in patients whose vertebral fracture had been identified using VFA software with densitometry. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

National Osteoporosis Foundation (NOF)

The National Osteoporosis Foundation’s 2014 guide to the prevention and treatment of osteoporosis stated:  “A vertebral fracture is consistent with a diagnosis of osteoporosis, even in the absence of a bone density diagnosis, and is an indication for pharmacologic treatment with osteoporosis medication to reduce fracture risk. Most vertebral fractures are asymptomatic when they first occur and often are undiagnosed for many years. Proactive vertebral imaging is the only way to diagnose these fractures. The finding of a previously unrecognized vertebral fracture may change the diagnostic classification, alters future fracture risk and subsequent treatment decisions.”

The guide recommended that vertebral imaging tests be considered in the following patients:

  • “All women age 70 and older and all men age 80 and older….
  • Women age 65 to 69 and men age 75 to 79 when BMD [bone mineral density] T-score is -1.5 or below.
  • Postmenopausal women age 50 to 64 and men age 50 to 69 … with specific risk factors:
  • Low-trauma fracture
  • Historical height loss of 1.5 in. or more (4 cm)
  • Prospective height loss of 0.8 in. or more (2 cm)
  • Recent or ongoing long-term glucocorticoid treatment.”

International Society for Clinical Densitometry

In 2019, the International Society for Clinical Densitometry updated its recommendations for selecting patients for vertebral fracture assessment (VFA), these recommendations remain the same as in a 2015 update. Lateral spine imaging with either standard radiography or densitometric VFA is indicated for patients with a T score of less than -1.0 when at least 1 of the following factors are present:

  • “Women age ≥70 years or men ≥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 per day for ≥3 mo.”

American Association of Clinical Endocrinologists and the American College of Endocrinology

The joint guidelines from the American Association of Clinical Endocrinologists and American College of Endocrinology (2016) on the diagnosis and treatment of postmenopausal osteoporosis included VFA recommendations similar to those of the International Society for Clinical Densitometry in 2013.

Endocrine Society

The Endocrine Society Clinical Practice Guideline (2019)on pharmacological management of osteoporosis in postmenopausal women states four managmentment principles:

  1. “The risk of future fractures in postmenopausal women should be determined using country-specific assessment tools to guide decision-making.
  2. Patient preferences should be incorporated into treatment planning.
  3. Nutritional and lifestyle interventions and fall prevention should accompany all pharmacologic regimens to reduce fracture risk.
  4. Multiple pharmacologic therapies are capable of reducing fracture rates in postmenopausal women at risk with acceptable with acceptable risk-benefit and safety profiles.”

American College of Physicians

The American College of Physicians’ (ACR) 2017 guidelines on the treatment of low bone density or osteoporosis include the following recommendations (see Table 1).

Guidelines on the Treatment of Low Bone Density or Osteoporosis

Recommendation

GOE

QOE

“ACP recommends that clinicians offer pharmacologic treatment with bisphosphonates to reduce the risk for vertebral fracture in men who have clinically recognized osteoporosis.”

Weak

Low

“ACP 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

GOE: grade of evidence; QOE: quality of evidence.

North American Menopause Society

The North American Menopause Society’s 2010 position statement on management of osteoporosis did not include a recommendation for or against VFA as part of the screening process. The statement indicated that vertebral fracture must be confirmed by lateral spine radiographs or VFA visualization of fracture at the time of BMD testing.

U.S. Preventive Services Task Force Recommendations (USPSTF)

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.

KEY WORDS:

Dual x-ray absorptiometry, DEXA, vertebral fracture, osteoporosis, morphometric x-ray absorptiometry, MXA, Instant vertebral assessment, IVA, Lateral Vertebral Assessment, LVA, bone mineral density, BMD, vertebral fracture assessment (VFA), dual energy vertebral assessment (DVA), Aria, GEHC DXA, TBS iNsight, QCT PRO, Lunar DXA

APPROVED BY GOVERNING BODIES:

Additional software is needed to perform VFA with a densitometer, and it must be cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process. Products cleared for marketing by the FDA are shown in the table below. Food and Drug Administration product code KGI.

Densitometry Devices cleared by the U.S. Food and Drug Administration

Device

Manufacturer

Date cleared

510(k) No.

Indication

GEHC DXA Bone Densitometers with enCORE version 18

GE Medical Systems Ultrasound & Primary Care Diagnostics LLC

9/19/2019

K191112

For use in vertebral fracture assessment

Aria

GE Medical Systems Ultrasound & Primary Care Diagnostics LLC

4/20/2018

K180782

For use in vertebral fracture assessment

GE Lunar DXA Bone Densitometers with enCORE version 17

GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC

12/2/2016

K161682

For use in vertebral fracture assessment

TBS iNsight

MEDIMAPS GROUP SA

4/29/2016

K152299

For use in vertebral fracture assessment

QCT PRO ASYNCHRONOUS CALIBRATION MODULE CLINIQCT

MINDWAYS SOFTWARE INC.

8/29/2014

K140342

For use in vertebral fracture assessment

ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS

GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGN

5/15/2014

K133664

For use in vertebral fracture assessment

BENEFIT APPLICATION:

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

ITS: Home Policy provisions apply

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

CURRENT CODING:

CPT codes:

77085

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

77086

Vertebral fracture assessment via dual-energy X-ray absorptiometry (DXA)

REFERENCES:

  1. Bhoopalam N, Campbell SC, Moritz T, et al. Intravenous zoledronic acid to prevent osteoporosis in a veteran population with multiple risk factors for bone loss on androgen deprivation therapy. J Urol. 2009; 182(5):2257-2264.
  2. Binkley N, Krueger D, Gangnon R, et al. Lateral vertebral assessment: A valuable technique to detect clinically significant vertebral fractures. Osteoporos Int. 2005; 16(12): 1513-1518.
  3. Camacho PM, Petak SM, Binkley N, et al. American Association of Clinical Endocrinologists and American College of Endocrinology clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis - 2016. Endocr Pract. Sep 02 2016; 22(Suppl 4):1-42.
  4. Centre for Metabolic Bone Diseases, University of Sheffield U. FRAX Fracture Risk Assessment Tool: Calculation Tool. n.d.; www.sheffield.ac.uk/FRAX/tool.aspx?country=9. Accessed August 31, 2017.
  5. Cosman F, de Beur SJ, LeBoff MS, et al. Clinician's Guide to Prevention and Treatment of Osteoporosis. Osteoporos Int. Oct 2014; 25(10):2359-2381.
  6. Cummings SR, Black DM, Thompson DE et al. Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: results from the Fracture Intervention Trial. JAMA. 1998; 280(24):2077-2082.
  7. Curry SJ, Krist AH, Owens DK, et al. Screening for Osteoporosis to Prevent Fractures: US Preventive Services Task Force Recommendation Statement. JAMA. Jun 26 2018; 319(24): 2521-2531.
  8. Damiano J, Kolta S, Porcher R, et al.  Diagnosis of vertebral fractures by vertebral fracture assessment.  J Clin Densitom. 2006; 9(1): 66-71.
  9. Diacinti D, Del Fiacco R, Pisani D et al. Diagnostic Performance of Vertebral Fracture Assessment by the Lunar iDXA Scanner Compared to Conventional Radiography. Calcif Tissue Int. 2012; 91(5):335-342.
  10. Diacinti D, Guglielmi G, Pisani D, et al. Vertebral morphometry by dual-energy X-ray absorptiometry (DXA) for osteoporotic vertebral fractures assessment (VFA). Radiol Med. 2012; 117(8):1374- 1385.
  11. Domiciano DS, Figueiredo CP, Lopes JB, et al. Vertebral fracture assessment by dual X-ray absorptiometry: a valid tool to detect vertebral fractures in community-dwelling older adults in a population-based survey. Arthritis Care Res (Hoboken). 2013; 65(5):809-815.
  12. Duboeuf F, Bauer DC, Chapurlat RD, et al.  Assessment of vertebral fracture using densitometric morphometry.  J Clin Densitom. 2005; 8(3): 362-368.
  13. Eastell R, Rosen CJ, Black DM, et al. Pharmacological management of osteoporosis in postmenopausal women: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. May 2019;104(5):1595-1622.
  14. El Maghraoui A, Mounach A, Rezqi A, et al. Vertebral fracture assessment in asymptomatic men and its impact on management. Bone. Apr 2012; 50(4): 853-7.
  15. El Maghraoui A, Rezqi A, Mounach A, et al. Systematic vertebral fracture assessment in asymptomatic postmenopausal women. Bone. Jan 2013; 52(1): 176-80.
  16. Endocrine Society Osteoporosis in Men. 2012. Available online at: www.endocrine.org/~/media/endosociety/Files/Publications/Clinical%20Practice%20Guidelines/FINAL-Osteoporosis-in-Men-Guideline.pdf.
  17. Ettinger B, Black DM, Mitlak BH, et al. Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: Results from a 3-year randomized clinical trial. JAMA. 1999; 282(7): 637-645.
  18. Ferrar L, Jiang G, Barrington NA, et al. Identification of vertebral deformities in women: Comparison of radiological assessment and quantitative morphometry using morphometric radiography and morphometric X-ray absorptiometry. J Bone Miner Res. 2000; 15(3): 575-585.
  19. Ferrar L, Jiang G, Clowes J, et al. Comparison of densitometric and radiographic vertebral fracture assessment using the algorithm-based qualitative (ABQ) method in postmenopausal women at low and high risk of fracture. J Bone Miner Res. 2007; 23(1):103-111.
  20. Ferrar L, Jiang G, Eastell R, et al. Visual identification of vertebral fractures in osteoporosis using morphometric X-ray absorptiometry. J bone Miner Res. 2003; 18(5): 933-938.
  21. Greenspan SL, Nelson JB, Trump DL, et al. Effect of once-weekly oral alendronate on bone loss in men receiving androgen deprivation therapy for prostate cancer. Ann Intern Med. 2007; 146(6):416-424.
  22. Greenspan SL, von Stetten E, Emond SK, et al. Instant vertebral assessment: A noninvasive dual X-ray absorptiometry technique to avoid misclassification and clinical mismanagement of osteoporosis. J Clin Densitometry. 2001; 4(4): 373-380.
  23. Harris ST, Watts NB, Genant HK, et al. Effects of risedronate treatment on vertebral and nonvertebral fractures in women with post menopausal osteoporosis: A randomized controlled trial. JAMA 1999; 282(14): 1344-1352.
  24. Hodgson Stephen F, Watts Nelson B, et al. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the prevention and treatment of postmenopausal osteoporosis: 2001 edition, with selected updates for 2003, Endocrine Practice. November/December 2003, Vol. 9, No. 6, pp. 544-564.
  25. Hologic. Hologic receives FDA 510(k) clearance for visual assessment of vertebral deformities, www.hologic.com/en/skeletal/osteoporosis-assessment/explorer/iva/.
  26. International Society for Clinical Densitometry. 2019 ISCD Official Positions – Adult. 2019; https://www.iscd.org/official-positions/2019-iscd-official-positions-adult/. Accessed July 23, 2019.
  27. International Society for Clinical Densitometry. 2015 ISCD Official Positions – Adult. 2015; https://www.iscd.org/official-positions/2015-iscd-official-positions-adult/. Accessed August 17, 2018.
  28. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  29. Jager PL, Jonkman S, Koolhaas W, et al. Combined vertebral fracture assessment and bone mineral density measurement: a new standard in the diagnosis of osteoporosis in academic populations. Osteoporos Int. 2011; 22(4):1059-1068.
  30. Jager PL, Slart RH, Webber CL, et al. Combined vertebral fracture assessment and bone mineral density measurement: A patient-friendly new tool with an important impact on the Canadian Risk Fracture Classification. Can Assoc Radiol J. 2010; 61(4):194-200.
  31. Kanis JA, Barton IP and Johnell O. Risedronate decreases fracture risk in patients selected solely on the basis of prior vertebral fracture. Osteoporos Int 2005; 16(5): 475-482.
  32. 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. May 2014; 25(5):1455-1464.
  33. Lee JH, Lee YK, Oh SH, et al. A systematic review of diagnostic accuracy of vertebral fracture assessment (VFA) in postmenopausal women and elderly men. Osteoporos Int. May 2016; 27(5):1691-1699.
  34. Liberman UA, Weiss SR, Broll J, et al. Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis. NEJM .1995; 333(22): 1437-1443.
  35. Malgo F, Hamdy NAT, Ticheler CHJM, 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. Osteoporos Int. Oct 2017;28(10): 2955-2965.
  36. Management of osteoporosis in postmenopausal women: 2010 position statement of The North American Menopause Society. Available online at: www.menopause.org/docs/default-document-library/psosteo10.pdf?sfvrsn=2.
  37. Mrgan M, Mohammed A, Gram J. Combined Vertebral Assessment and Bone Densitometry Increases the Prevalence and Severity of Osteoporosis in Patients Referred to DXA Scanning. J Clin Densitom. 2013; 16(4):549-553.
  38. National Osteoporosis Foundation. The Clinician's Guide to Prevention and Treatment of Osteoporosis 2013. Available online at: nof.org/files/nof/public/content/file/917/upload/481.pdf.
  39. North American Menopause Society. Management of osteoporosis in postmenopausal women:  2006 Position Statement of the North American Menopause Society. Menopause. 2006; 13(3): 340-367.
  40. North American Menopause Society. Management of osteoporosis in postmenopausal women: 2010 position statement. www.menopause.org/docs/default-document-library/psosteo10.pdf?sfvrsn=2.
  41. Qaseem A, Forciea MA, McLean RM, et al. 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.
  42. Quandt SA, Thompson DE, Schneider DL, et al. Effect of alendronate on vertebral fracture risk in women with bone mineral density T scores of-1.6 to -2.5 at the femoral neck: the Fracture Intervention Trial. Mayo Clin Proc. 2005; 80(3):343-349.
  43. Rea JA, Chen MB, Li J, et al. Morphometric X-ray absorptiometry and morphometric radiography of the spine: A comparison of prevalent vertebral deformity identification. J Bone Miner Res. 2000; 15(3): 564-574.
  44. Rea JA, Li J, Blake GM, et al. Visual assessment of vertebral deformity by X-ray absorptiometry: A highly predictive method to exclude vertebral deformity. Osteoporos Int. 2000; 11(8): 660-668.
  45. Rosen HN, Vokes TJ, Malabanan AO, et al. The official positions of the international society for clinical densitometry: vertebral fracture assessment. J Clin Densitom. 2013; 16(4):482-488.
  46. Schousboe JT, DeBold R, Bowles C, et al. Prevalence of vertebral compression fracture deformity by X-ray absorptiometry of lateral thoracic and lumbar spines in a population referred for bone densitometry. J Clin Densitometry. 2002; 5(3): 239-246.
  47. Shepherd JA, Schousboe JT, Broy SB, et al. Executive Summary of the 2015 ISCD Position Development Conference on Advanced Measures From DXA and QCT: Fracture Prediction Beyond BMD. J Clin Densitom. Jul-Sep 2015; 18(3): 274-86.
  48. Sullivan S, Wagner J, Resnick NM, et al. Vertebral fractures and the misclassification of osteoporosis in men with prostate cancer. J Clin Densitom. 2011; 14(3):348-353.
  49. The International Society for Clinical Densitometry. 2019 ISCD Official Position Adult. 2019; https://www.iscd.org/official-positions/2019-iscd-official-positions-adult/.
  50. U.S. Preventive Services Task Force. Osteoporosis Screening. 2018 www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/osteoporosis-screening?ds=1&s=osteoporosis.
  51. 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.
  52. Van den Berg M, Verdijk NA, van den Bergh JP, et al. Vertebral fractures in women aged 50 years and older with clinical risk factors for fractures in primary care. Maturitas. 2011; 70(1):74-79.
  53. Vokes TJ, Dixon LB, and Favus MJ. Clinical utility of dual-energy vertebral assessment (DVA). Osteoporos Int. 2003; 14(11): 871-878.
  54. Watts NB, Adler RA, Bilezikian JP, et al. Osteoporosis in men: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. Jun 2012;97(6):1802-1822.
  55. 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.

POLICY HISTORY:

Medical Policy Group, August 2004 (1)

Medical Policy Administration Committee, August 2004

Available for comment August 24-October 7, 2004

Medical Policy Group, August 2005 (1)

Medical Policy Group, August 2006 (1)

Medical Policy Group, August 2007 (1)

Medical Policy Administration Committee, August 2007

Available for comment July 27-September 10, 2007

Medical Policy Group, February 2009 (1)

Medical Policy Group, August 2010 (1): Key Points updated, no change in policy statement

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

Medical Policy Panel, January 2013

Medical Policy Group, February 2013 (1): Update to Title, Description, Key Points, Key Words, and References; no change to policy statement

Medical Policy Panel, January 2014

Medical Policy Group, January 2014 (1): Update to Key Points and References; no change to policy statement

Medical Policy Panel, May 2014

Medical Policy Group, June 2014 (1): Update to Key Points and References; no change to policy statement.

Medical Policy Group, November 2014: 2015 Annual Coding update. Added codes 77085, 77086 to current coding.  Added Previous coding section to include code 77082.

Medical Policy Panel, May 2015

Medical Policy Group, May 2015 (4): Update made to Key Points.  No change in policy statement.

Medical Policy Panel, September 2016

Medical Policy Group, September 2016 (7):  Update to Key Points and References.  No change in policy statement.

Medical Policy Panel, September 2017

Medical Policy Group, September 2017 (7): Update to Description, Key Points and Practice Guidelines, and References. Removed Previous Coding Section (77082 deleted effective Jan 2015). No change in policy statement.

Medical Policy Panel, October 2018

Medical Policy Group, October 2018 (7):  Update to Key Points and References.  No change in policy statement.

Medical Policy Panel, October 2019

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

Medical Policy Panel, September 2020

Medical Policy Group, October 2020 (7):  Update to Key Points, Approved by Governing Bodies and References. Added Key Words: "Aria, GEHC DXA, TBS iNsight, QCT PRO, Lunar DXA".  No change in policy statement.

Medical Policy Panel, September 2021

Medical Policy Group, September 2021 (7): Updates to Key Points and References. Policy statement updated to remove “not medically necessary,” no change to policy intent.

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

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

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

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

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

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

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

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