Bone Mineral Density Studies

Bone Mineral Density Studies Policy Number: 6.01.01 Origination: 10/1988 Last Review: 5/2016 Next Review: 5/2017 Policy Blue Cross and Blue Shield ...
Author: Muriel James
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Bone Mineral Density Studies Policy Number: 6.01.01 Origination: 10/1988

Last Review: 5/2016 Next Review: 5/2017

Policy

Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage for bone density studies when it is determined to be medically necessary because the criteria shown below are met.

When Policy Topic is covered

An initial measurement of BMD at the hip or spine may be considered medically necessary to assess fracture risk and the need for pharmacologic therapy in both women and men who are considered at risk for osteoporosis. BMD testing may be indicated under the following conditions:     

Women age 65 and older, regardless of other risk factors; Men age 70 and older, regardless of other risk factors; Younger postmenopausal women about whom there is a concern based on their risk factors; Men age 50-70 about whom there is a concern based on their risk factors; Adults with a condition or taking a medication associated with low bone mass or bone loss.

Repeat measurement of central (hip/spine) BMD for individuals who previously tested normal (does not require pharmacologic treatment) may be considered medically necessary at an interval not more frequent than every 3–5 years; the interval depends on patient risk factors. Regular (not more frequent than every 2-3 years) serial measurements of central BMD to monitor treatment response may be considered medically necessary when the information will affect treatment decisions such as duration of therapy.

When Policy Topic is not covered A bone density study is considered screening for those individuals not considered at high risk for osteoporosis. Initial or repeat BMD measurement is not indicated unless the results will influence treatment decisions.

Considerations The decision to perform bone density assessment should be based on an individual’s fracture risk profile and skeletal health assessment. (1) In addition to age, gender, and bone mineral density (BMD), risk factors included in the World Health Organization (WHO) Fracture Risk Assessment Model (FRAX) are:  Low body mass index;  Parental history of hip fracture;  Previous fragility fracture in adult life (i.e., occurring spontaneously, or a fracture arising from trauma which, in a healthy individual, would not have resulted in a fracture);  Current smoking or alcohol 3 or more units/day, where a unit is equivalent to a standard glass of beer (285ml), a single measure of spirits (30ml), a mediumsized glass of wine (120ml), or 1 measure of an aperitif (60ml);  A disorder strongly associated with osteoporosis. These include rheumatoid arthritis, type I (insulin dependent) diabetes, osteogenesis imperfecta in adults, untreated long-standing hyperthyroidism, hypogonadism or premature menopause (70 years), low body mass index, weight loss, physical inactivity, corticosteroid use, androgen deprivation therapy, and previous fragility fracture. ACP recommends that clinicians obtain DXA for men who are at increased risk for osteoporosis and are candidates for drug therapy (grade: strong recommendation; moderate-quality evidence). The guidelines indicate that bone density measurement with DXA is the accepted reference standard for diagnosing osteoporosis in men; because treatment trials have not measured the effectiveness of therapy for osteoporosis diagnosed by ultrasound densitometry rather than DXA, the role of ultrasound in diagnosis remains uncertain. This evidence review found no studies that evaluated the optimal intervals for repeated screening by using BMD measurement with DXA in men.

American College of Radiology Practice guidelines from the American College of Radiology, last amended in 201421 state that BMD measurement is indicated whenever a clinical decision is likely to be directly influenced by the result of the test. Indications for DXA include but are not to the following patient populations: 





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All women age 65 years and older and men age 70 years and older (asymptomatic screening). o Women younger than age 65 years who have additional risk for osteoporosis, based on medical history and other findings. Additional risk factors for osteoporosis include: a. Estrogen deficiency b. A history of maternal hip fracture that occurred after the age of 50 years. c. Low body mass (less than 127 lb or 57.6 kg). d. History of amenorrhea (more than 1 year before age 42 years). Women younger than age 65 years or men younger than age 70 years who have additional risk factors, including: a. Current use of cigarettes b. Loss of height, thoracic kyphosis. Individuals of any age with bone mass osteopenia, or fragility fractures on imaging studies such as radiographs, computed tomography (CT, or magnetic resonance imaging [MRI]) Individuals age 50 years and older who develop a wrist, hip, spine, or proximal humerus fracture with minimal or no trauma, excluding pathologic fractures. Individuals of any age who develop 1 or more insufficiency fractures. Individuals receiving (or expected to receive) glucocorticoid therapy for more than 3 months. Individuals beginning or receiving long-term therapy with medications known to adversely affect BMD (e.g., anticonvulsant drugs, androgen deprivation therapy, aromatase inhibitor therapy, or chronic heparin. Individuals with an endocrine disorder known to adversely affect BMD (e.g., hyperparathyroidism, hyperthyroidism, or Cushing’s syndrome). o Hypogonadal men older than 18 years and men with surgically or chemotherapeutically induced castration. o Women younger than age 65 years who have additional risk for osteoporosis, based on individuals with medical conditions that could alter BMD, such as: a. Chronic renal failure. b. Rheumatoid arthritis and other inflammatory arthritis. c. Eating disorders, including anorexia nervosa and bulimia. d. Organ transplantation. e. Prolonged immobilization. f. Conditions associated with secondary osteoporosis, such as gastrointestinal malabsorption or malnutrition, sprue, osteomalacia, vitamin D deficiency, acromegaly, chronic alcoholism chronic alcoholism or established cirrhosis, and multiple myeloma

g. Individuals who have had gastric bypass for obesity. The accuracy of DXA in these patients might be affected by obesity. o Individuals being considered for pharmacologic therapy for osteoporosis. o Individuals being monitored to: a. Assess the effectiveness of osteoporosis drug therapy. b. Follow-up medical conditions associated with abnormal BMD. International Society for Clinical Densitometry The 2013 update of the International Society for Clinical Densitometry guidelines recommend bone density testing in the following patients 22:  

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Women age 65 and older; Postmenopausal women under age 65 with risk factors for fracture such as; o Low body weight o Prior fracture o High risk medication use o Disease or condition associated with bone loss. Women during the menopausal transition with clinical risk factors for fracture, such as low bone weight, prior fracture or high-risk medication use; Men age 70 and older; Men under age 70 if they have a risk factors for low bone mass such as; o Low body weight o Prior fracture o High risk medication use o 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 Anyone being considered for pharmacologic therapy; Anyone being treated, to monitor treatment effect. Anyone not receiving therapy in whom evidence of bone loss would lead to treatment

In 2010, the American Association of Clinical Endocrinologists issued guidelines for the diagnosis and treatment of postmenopausal osteoporosis. 23 The guidelines list the potential uses for BMD measurements in postmenopausal women as:       

Screening for osteoporosis Establishing the severity of osteoporosis or bone loss Determining fracture risk Identifying candidates for pharmacologic intervention Assessing changes in bone mass over time Enhancing acceptance of and perhaps adherence with treatment Assessing skeletal consequences of diseases, conditions, or medications known to cause bone loss

North American Menopause Society The North American Menopause Society issued a 2010 position statement, 24 which states that fracture is the most significant risk of low bone density. The statement

also concludes that BMD is an important determinant of fracture risk, especially in women 65 years and older. U.S. Preventive Services Task Force Recommendations The U.S. Preventive Services Task Force (USPSTF) updated recommendations on screening for osteoporosis with bone density measurements in January 2011. 25 USPSTF recommends routine osteoporosis screening in women age 65 years or older and in younger women whose risk of fracture is at least equal to that of a 65-year-old average-risk white woman. This represents a change from the previous (2002) version in which there was no specific recommendation regarding screening in women younger than 65 years old. The supporting document notes that there are multiple instruments to predict risk for low BMD and that the USPSTF used FRAX.1 The updated USPSTF recommendations state that the scientific evidence is insufficient to recommend for or against routine osteoporosis screening in men. The Task Force did not recommend specific screening tests but said that the most commonly used tests are DXA of the hip and lumbar spine and quantitative ultrasound of the calcaneus. USPSTF recommendations state the following on BMD screening intervals: “…A lack of evidence exists about the optimal intervals for repeat screening and whether repeated screening is necessary in a woman with normal BMD. Because of limitations in the precision of testing, a minimum of 2 years may be needed to reliably measure a change in BMD; however, longer intervals may be necessary to improve fracture risk prediction.” Medicare National Coverage Medicare pays for a screening bone mass measurement (BMM) once every 2 years (at least 23 months have passed since the month the last covered BMM was performed).26 When medically necessary, Medicare may pay for more frequent BMMs. Examples include, but are not limited to, monitoring beneficiaries on longterm glucocorticoid (steroid) therapy of more than 3 months, and confirming baseline BMMs to permit monitoring of beneficiaries in the future. Conditions for coverage of BMM can be found in chapter 15, section 80.5 of Pub. 100-02, Medicare Benefit Policy Manual. Medicare covers BMM under the following conditions: 1. Is ordered by the physician or qualified nonphysician practitioner who is treating the beneficiary following an evaluation of the need for a BMM and determination of the appropriate BMM to be used. 2. Is performed under the appropriate level of physician supervision as defined in 42 CFR 410.32(b). 3. Is reasonable and necessary for diagnosing and treating the condition of a beneficiary who meets the conditions described in §80.5.6. 4. In the case of an individual being monitored to assess the response to or efficacy of an FDA-approved osteoporosis drug therapy, is performed with a dual-energy x-ray absorptiometry system (axial skeleton).

5. In the case of any individual who meets the conditions of 80.5.6 and who has a confirmatory BMM, is performed by a dual-energy x-ray absorptiometry system (axial skeleton) if the initial BMM was not performed by a dual-energy x-ray absorptiometry system (axial skeleton). A confirmatory baseline BMM is not covered if the initial BMM was performed by a dual-energy x-ray absorptiometry system (axial skeleton). References 1. World Health Organization (WHO). Fracture risk assessment tool. http://www.shef.ac.uk/FRAX/tool.jsp 2. Lewiecki EM, Compston JE, Miller PD, et al. Official positions for FRAX® Bone Mineral Density and FRAX® simplification from Joint Official Positions Development Conference of the International Society for Clinical Densitometry and International Osteoporosis Foundation on FRAX®. J Clin Densitom. 2011;14(3):226-236. 3. National Osteoporosis Foundation. Osteoporosis: Review of the evidence for prevention, diagnosis and treatment and cost-effectiveness analysis. Osteoporosis Int. 1998;8(suppl 4):188. 4. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Ultrasonography of the heel for diagnosing osteoporosis and selecting patients for pharmacologic treatment. TEC Assessments. 1999;Volume 14, Tab 19. 5. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Ultrasonography of peripheral sites for diagnosing and selecting patients for pharmacologic treatment for osteoporosis. TEC Assessments. 2002;Volume 17, Tab 5. 6. Gadam RK, Schlauch K, Izuora KE. Frax prediction without BMD for assessment of osteoporotic fracture risk. Endocr Pract. Sep-Oct 2013;19(5):780-784. PMID 24121261 7. Oregon Evidence-based Practice Center prepared to Agency for Healthcare Research and Quality (AHRQ). Screening for Osteoporosis: Systematic Review to Update the 2002 U.S. Preventive Services Task Force Recommendation. http://www.ncbi.nlm.nih.gov/books/NBK45201/pdf/TOC.pdf 8. Johnell O, Kanis JA, Oden A, et al. Predictive value of BMD for hip and other fractures. J Bone Miner Res. 2005;20(7):1185-1194. 9. Berry SD, Samelson EJ, Pencina MJ, et al. Repeat bone mineral density screening and prediction of hip and major osteoporotic fracture. JAMA. Sep 25 2013;310(12):1256-1262. PMID 24065012 10. Gourlay ML, Fine JP, Preisser JS, et al. Bone-density testing interval and transition to osteoporosis in older women. N Engl J Med. Jan 19 2012;366(3):225-233. PMID 22256806 11. Berger C, Langsetmo L, Joseph L, et al. Change in bone mineral density as a function of age in women and men and association with the use of antiresorptive agents. CMAJ. 2008;178(13):1660-1668. 12. Frost SA, Nguyen ND, Center JR, et al. Timing of repeat BMD measurements: development of an absolute risk-based prognostic model. J Bone Miner Res. 2009;24(11-Jan):1800-1807. 13. Hillier TA, Stone KL, Bauer DC, et al. Evaluating the value of repeat bone mineral density measurement and prediction of fractures in older women: the study of osteoporotic fractures. Arch Intern Med. Jan 22 2007;167(2):155-160. PMID 17242316 14. Bell KJ, Hayen A, Macaskill P, et al. Value of routine monitoring of bone mineral density after starting bisphosphonate treatment: secondary analysis of trial data. BMJ. 2009;338:b2266. PMID 19549996 15. Bauer DC, Schwartz A, Palermo L, et al. Fracture prediction after discontinuation of 4 to 5 years of alendronate therapy: the FLEX study. JAMA Intern Med. Jul 2014;174(7):1126-1134. PMID 24798675 16. Black DM, Schwartz AV, Ensrud KE, 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. Dec 27 2006;296(24):2927-2938. PMID 17190893 17. Gourlay ML, Ensrud KE. Bone density and bone turnover marker monitoring after discontinuation of alendronate therapy: an evidence-based decision to do less. JAMA Intern Med. Jul 2014;174(7):1134-1135. PMID 24798510

18. American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins. Osteoporosis (Practice Bulletin N. 129). Obstet Gynecol. Sep 2012, reaffirmed 2014;120(3):718-734. PMID 22914492 19. National Osteoporosis Foundation. Clinician’s guide to prevention and treatment of osteoporosis. 2014; https://my.nof.org/file/bonesource/Clinicians-Guide.pdf. Accessed July 16, 2015. 20. Qaseem A, Snow V, Shekelle P, et al. Screening for osteoporosis in men: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2008;148(9-Jan):680-4. 21. American College of Radiologists (ACR). ACR–SPR–SSR Practice Parameter for the Performance of Dual-Energy X-Ray Absorptometry (DXA) 2014; http://www.acr.org/~/media/eb34da2f786d4f8e96a70b75ee035992.pdf 22. International Society for Clinical Densitometry. 2013 ISCD Official Positions-Adult 2013; http://www.iscd.org/official-positions/2013-iscd-official-positions-adult/ 23. American Association of Clinical Endocrinologists A. Medical Guidelines for Clinical Practice for the Diagnosis and Treatment of Postmenopausal Osteoporosis. Endocr. Pract. 2010; 16 Suppl 3: 1-37. 2010. 24. North American Menopause Society. Position Statement: Management of Osteoporosis in Postmenopausal Women. Menopause 2010: 17(1): 25-54. 2010. 25. U.S. Preventive Services Task Force (USPSTF). Screening for osteoporosis. http://www.uspreventiveservicestaskforce.org/uspstf/uspsoste.htm 26. Centers for Medicare & Medicaid Services (CMS). National Coverage Determination for Bone (Mineral) Density Studies (150.3). http://www.cms.gov/Regulations-andGuidance/Guidance/Transmittals/downloads/R70BP.pdf

Billing Coding/Physician Documentation Information 76977 Ultrasound bone density measurement and interpretation, peripheral site(s) 77078 Quantitative Computerized Tomography bone mineral density study, one or more sites, axial skeleton (eg hips, pelvis spine) 77080 Dual energy x-ray absorptiometry (DEXA), bone density study, one or more sites; axial skeleton (eg, hips, pelvis, spine) 77081 Dual energy x-ray absorptiometry (DEXA), bone density study, one or more sites; appendicular skeleton (peripheral) (eg, radius, wrist, heel) 78350 Bone density (bone mineral content) study, 1 or more sites; single photon absorptiometry 78351 Bone density (bone mineral content) study, 1 or more sites; dual photon absorptiometry, 1 or more sites G0130 Single energy x-ray absorptiometry bone density study, one or more sites; appendicular skeleton (peripheral - e.g., radius, wrist, heel) M81.0 M81.6 M81.8

ICD10 Codes: Age-related osteoporosis without current pathological fracture Localized osteoporosis Other osteoporosis without current pathological fracture

CPT codes 77079 and 77083 were deleted effective 1/1/2012.

Additional Policy Key Words N/A

Policy Implementation/Update Information 10/1/88

New policy added to Radiology section. Considered medically necessary for high risk individuals and those receiving therapy for osteoporosis to monitor bone mass. 3/1/00 No policy statement change. 3/1/01 Additional high risk criteria added, definition updated to include description of various techniques that may be used. 3/1/02 Policy statement revised to indicate Appendicular studies are not medically necessary, low risk individuals are contract exclusions, and ultrasound of a peripheral site is investigational. 3/1/03 No policy statement changes. 3/1/04 Policy statement revised to include current fracture or history of fracture in first-degree relative as a risk factor in the criteria for Postmenopausal women under age 65 who have one or more risk factors. 5/1/05 Policy statement revised to indicate axial bone mineral density by either DXA or QCT may be considered medically necessary for high risk individuals, added depo-provera to the list of high-risk, changed serial measurements from medically necessary to not medically necessary, changed ultrasound of any site to not medically necessary. 4/1/06 Clarified policy statement regarding patients who are at low risk for developing osteoporosis. Those individuals not meeting the criteria for high risk are considered low risk; bone density screening would therefore be a contract exclusion. 3/1/07 No policy statement changes. CPT codes updated, rationale updated. 3/1/08 Policy statement clarified to specify both women and men. Specific criteria are no longer in the policy statement. The description and rationale reference criteria used. 12/11/08 Interim update: Policy updated with literature review; references added and reordered. Clinical input reviewed. Policy statement added; repeat measurement (3-5 year interval) may be medically necessary if previously normal; serial testing (at least 2 year interval) changed to medically necessary. Policy title changed from Bone Density Studies to Bone Mineral Density Studies. 3/1/09 No policy statement changes. 3/1/10 No policy statement changes. Policy clarified in Considerations section regarding reimbursement for peripheral scans. 3/1/11 No policy statement changes. 3/1/12 No policy statement changes. 3/1/13 No policy statement changes. 3/1/14 No policy statement changes. 5/1/14 No policy statement changes. 5/1/15 No policy statement changes. 5/1/16 No policy statement changes. State and Federal mandates and health plan contract language, including specific provisions/exclusions, take precedence over Medical Policy and must be considered first in

determining eligibility for coverage. The medical policies contained herein are for informational purposes. The medical policies do not constitute medical advice or medical care. Treating health care providers are independent contractors and are neither employees nor agents Blue KC and are solely responsible for diagnosis, treatment and medical advice. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, photocopying, or otherwise, without permission from Blue KC.

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