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Medical Policy: 02.04.13
Original Effective Date: October 2007
Reviewed: August 2011
Revised: August 2011
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:
Bone turnover markers are biochemical markers of either bone formation or bone resorption. Commercially available tests assess some of these markers in urine and/or serum by high performance liquid chromatography (HPLC) or immunoassay. Assessment of bone turnover markers is proposed to supplement bone mineral density (BMD) measurements in the diagnosis of osteoporosis and aid in treatment decisions. Bone turnover markers could also potentially be used to evaluate treatment effectiveness before changes in BMD can be observed.
After cessation of growth, bone is in a constant state of remodeling or turnover, with initial absorption of bone by osteoclasts followed by deposition of new bone matrix by osteoblasts. This constant bone turnover is critical to the overall health of the bone, by repairing microfractures and remodeling the bony architecture in response to stress. However, it must be emphasized that the presence of bone-turnover markers in the serum or urine is not necessarily related to bone loss. For example, even if bone turnover is high, if resorption is balanced with formation, there will be no net bone loss. Bone loss will only occur if resorption exceeds formation.
Bone-turnover markers have been extensively researched in diseases associated with markedly high levels of bone turnover, such as Paget’s disease, primary hyperparathyroidism, glucocorticoid-induced osteoporosis, or renal osteodystrophy. There has been recent interest in the use of bone-turnover markers to evaluate age-related osteoporosis, a disease characterized by slow, prolonged bone loss, resulting in an increased risk of fractures at the hip, spine, or wrist. Currently, fracture risk is based primarily on measurements of BMD in conjunction with other genetic and environmental factors, such as family history of osteoporosis, history of smoking, and weight. It is thought that the level of bone-turnover markers may also predict fracture risk, possible through a different mechanism that that associated with BMD. However, it must be emphasized that the presence of bone-turnover markers in the serum or urine is not necessarily related to bone loss. For example, even if bone turnover is high, if resorption is balanced with formation, there will be no net bone loss. Bone loss will only occur if resorption exceeds formation. Therefore, bone-turnover makers have been primarily studied as an adjunct, not an alternative, to measurements of BMD to estimate fracture risk and document the need for preventive or therapeutic strategies for osteoporosis.
In addition, bone turnover markers might provide a more immediate assessment of treatment response and predict change in BMD in response to treatment. Treatment-related changes in BMD occur very slowly. This fact, coupled with the precision of BMD technologies, suggested that clinically significant changes in BMD could not be reliably detected until at least 2 years. In contrast, changes in bone turnover markers could be anticipated after 3 months of therapy.
Collagen cross-links are generally reliable markers of bone resorption because they are stable in serum and urine. These marker links bind 3 molecules of collagen in the bone and are released from the bone matrix after resorption, either free or bound to the N- or C-telopeptide of collagen. Collagen cross-links may be detected using either HPLC (Pyr and d-Pyr) or immunoassays (Pyr, dPyr, CTx, NTx). In addition to collagen cross-links, alkaline phosphatase (ALP) is a commonly used marker due to its ease of measurement; however, it lacks sensitivity and specificity for detecting osteoporosis since only about half of the ALP activity is derived from bone. Bone-specific alkaline phosphatase (B-ALP) is a better marker of bone formation than ALP. Serum osteocalcin is a small noncollagenous protein that is a product of osteoblasts and thus increased levels reflect bone formation. Tartrate-resistant acid phosphatase (TRAP) is produced by osteoclasts; it is thought to be active in bone matrix degradation.
Several tests for bone turnover markers have been cleared by the U.S> Food and Drug Administration (FDA) using the 510(k) process:
Collagen cross-links tests:
Pyrilinks test (Metra Biosystems, Santa Clara, CA) measures collagen type 1 cross-link, pyridium.
Osteomark test (Ostex International, Seattle, WA) measures cross-linked N-telopeptides of type 1 collagen (NTx).
Serum Crosslaps One-step ELISA test measures hydroxyproline.
Other bone turnover tests:
Ostase (Beckman Coulter) measures bone-specific alkaline phosphatase (B-ALP).
N-MID Osteocalcin One-step ELISA (Osteometer Bio Tech) measures osteocalcin (OC)
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Prior Approval:
Not applicable
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Policy:
Measurement of bone turnover markers is considered investigational in the diagnosis and management of osteoporosis.
The literature suggests that alternative measures of bone strength have the potential to assess individual responses to treatment or identify individuals at high risk of future fracture, thereby potentially altering clinical management. However, there is insufficient evidence that current methods for measuring bone turnover markers are sufficiently sensitive to reliably determine individual treatment responses. Measurement of bone turnover has not been shown to improve health outcomes.
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Procedure Codes and Billing Guidelines:
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To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
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82523 collagen cross links, any method
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83937 osteocalcin (bone g1a protein)
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84080 Phosphatase, alkaline; isoenzymes
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Selected References:
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National Osteoporosis Foundation. Physician’s guide to prevention and treatment of osteoporosis. April 2003.
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Stepan JJ. Clinical utility of bone markers in the evaluation and follow-up of osteoporotic patients: why are the markers poorly accepted by clinicians? J Endocrinol Invest. 2003 May;26(5):458-63.
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Meunier PJ, Roux C, et al. The effects of strontium ranelate on the risk of vertebral fracture in women with postmenopausal osteoporosis. N Engl J Med. 2004 Jan 29;350(5):459-68.
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Paschalis EP, Glass EV,et al. Bone mineral and collagen quality in iliac crest biopsies of patients given teriparatide: new results from the fracture prevention trial. J Clin Endocrinol Metab. 2005 Aug;90(8):4644-9.
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Bauer DC, Garnero P, et al. Pretreatment levels of bone turnover and the antifracture efficacy of alendronate: the fracture intervention trial. J Bone Miner Res. 2006 Feb;21(2):292-9.
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Black DM, Schwartz AV,et al. Effects of continuing or stopping alendronate after 5 years of treatment: the Fracture Intervention Trial Long-term Extension (FLEX): a randomized trial. JAMA. 2006 Dec 27;296(24):2927-38.
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Deane A, Constancio L, et al. The impact of vitamin D status on changes in bone mineral density during treatment with bisphosphonates and after discontinuation following long-term use in post-menopausal osteoporosis. BMC Musculoskelet Disord. 2007 Jan 10;8:3.
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Bergmann P, Body JJ, Boonen S et al. Evidence-based guidelines for the use of biochemical markers of bone turnover in the selection and monitoring of bisphosphonate treatment in osteoporosis: a consensus document of the Belgian Bone Club. Int J Clin Pract 2008;63(1):19-26.
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Shiraki M, itabashi A. Short-term menatetrenone therapy increases gamma-carboxylation of osteocalcin with a moderate increase of bone turnover in postmenopausal osteoporosis: a randomized prospective study. J Bone Miner Metab 2009; 27(3):333-40.
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Management of osteoporosis in postmenopausal women: 2010 position statement of the North American Menopause Society. Available online at www.guideline.gov. Last accessed August 2011.
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Policy History:
Date Reason Action
August 2011 Annual review Policy revised
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
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and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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