Clinical Policy: Vitamin D Screening Reference Number: CP.MP.HN499

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Clinical Policy: Vitamin D Screening Reference Number: CP.MP.HN499 Effective Date: 12/09 Last Review Date: 7/17 Coding Implications Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description Vitamin D, also known as calciferol, is a lipid or fat-soluble vitamin whose metabolites have a significant clinical role in the interrelationship of vitamin D with calcium homeostasis and bone metabolism. Screening for vitamin D deficiency of persons without a clinically documented underlying disease or condition which is specifically associated with the risk of decreased bone density or osteoporosis is not recommended. The role of vitamin D is also being evaluated for various indications other than bone health, including cardiovascular disease and hypertension, diabetes and metabolic syndrome, colon, prostate, and breast cancer. Policy/Criteria I. It is the policy of Health Net of California that Vitamin D screening for the general healthy population is considered investigational unless a specific disorder that may cause vitamin D deficiency or intoxication (such as disorders of calcium metabolism, malnutrition, malabsorption, long term use of specific medication such as glucocorticosteroids, diseases of the bone, nutrition and renal disease) is present or suspected, or to monitor therapeutic response of treatment for Vitamin D-related disorders Background Vitamin D is a fat-soluble vitamin that helps regulate calcium homeostasis and bone health. Important sources of vitamin D include diet (such as fatty fish, cod liver oil, dairy products, fortified beverages and foods, and supplements) and from exposure of the skin to sunlight. Vitamin D produced in the skin may last at least twice as long in the blood compared with ingested vitamin D. The recommended daily allowance of 400 IU/day (10 μg) is generally consumed in the diet except in certain groups at risk for developing vitamin D deficiency, including breast-fed infants, strict vegetarians abstaining from eggs and milk, and the elderly. The Institute of Medicine (IOM) in 2010 noted the Recommended Dietary Allowance (RDA) of vitamin D for healthy children 1 to 18 years, pregnant women, and healthy nonpregnant adults through age 70 years is 600 international units, with the RDA increasing to 800 international units after age 70 years. The National Osteoporosis Foundation (NOF) recommend at least 1000 international units, and 800 to 1000 international units daily, respectively, to older adults ( 65 years) to reduce the risk of fractures and falls Vitamin D deficiency results in abnormalities in calcium, phosphorus, and bone metabolism. Specifically, vitamin D deficiency causes a decrease in the efficiency of intestinal calcium and phosphorus absorption of dietary calcium and phosphorus, resulting in an increase in parathyroid hormone (PTH) levels. Secondary hyperparathyroidism maintains serum calcium in the normal range at the expense of mobilizing calcium from the skeleton and increasing phosphorus wasting in the kidneys. As a result there may be bone weakness and a generalized decrease in bone Page 1 of 5

mineral density (BMD), resulting in osteopenia and osteoporosis. Vitamin D deficiency may also cause muscle weakness making standing and walking difficult for affected children. In the elderly, more frequent falls may occur, which increases their risk of fracture. The U.S. Preventive Services Task Force (USPSTF) (2015) found no studies that evaluated the direct benefit of screening for vitamin D deficiency in adults. The USPSTF found adequate evidence that treatment of asymptomatic vitamin D deficiency has no benefit on cancer, type 2 diabetes mellitus, risk for death in community-dwelling adults, and risk for fractures in persons not selected on the basis of being at high risk for fractures. The USPSTF found inadequate evidence on the benefit of treatment of asymptomatic vitamin D deficiency on other outcomes, including psychosocial and physical functioning. Although the evidence is adequate for a few limited outcomes, the overall evidence on the early treatment of asymptomatic, screen-detected vitamin D deficiency in adults to improve overall health outcomes is inadequate. A clinical guideline from the Endocrine Society (2011) on the evaluation, treatment and prevention of Vitamin D deficiency recommends screening for vitamin D deficiency in individuals at risk for deficiency. They do not recommend population screening for vitamin D deficiency in individuals who are not at risk. Per the guideline, There is no evidence demonstrating benefits of screening for vitamin D deficiency at a population level. Such evidence would require demonstration of the feasibility and cost-effectiveness of such a screening strategy, as well as benefits in terms of important health outcomes. In the absence of this evidence, it is premature to recommend screening at large at this time. High risk for vitamin D deficiency include those individuals with osteoporosis, chronic kidney failure, malabsoprtion syndromes, hyperparathyroidism, African-American and Hispanic children and adults, pregnant or lactating women, older adults with history of falls or non-traumatic fractures, obese children or adults (BMI greater than 30 kg/m2), granuloma-forming disorders, and some lymphomas. Coding Implications This clinical policy references Current Procedural Terminology (CPT ). CPT is a registered trademark of the American Medical Association. All CPT codes and descriptions are copyrighted 2015, American Medical Association. All rights reserved. CPT codes and CPT descriptions are from the current manuals and those included herein are not intended to be all-inclusive and are included for informational purposes only. referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services. CPT Description 82306 Vitamin D; 25 Hydroxy, includes fraction(s) 82652 Vitamin D; 1, 25 Dihydroxy, includes fraction(s) HCPCS Description Page 2 of 5

HCPCS Description ICD-10-CM Diagnosis that Support Coverage Criteria (may not be all inclusive) ICD-10-CM Description Code E20.0-E20.9 Hypoparathyroidism E21.0-E21.5 Hyperparathyroidism and other disorders of the parathyroid gland E55.0 Rickets, active E55.9 Vitamin D deficiency, unspecified E83.30-E83.39 Disorders of phosphorus metabolism and phosphatases F83.51 Hypocalcemia F83.52 Hypercalcemia M80.00-M80.88 Age-related osteoporosis with current pathological fracture M81.000-M81.8 Other osteoporosis without current pathological fracture M83.0-M83.9 Adult osteomalacia M89.9 Disorder of bone, unspecified M94.9 Disorder of cartilage, unspecified N18.x Kidney disease N18.6 End stage renal disease N25.81 Secondary hyperparathyroidism of renal origin K50.x Diseases of the bowel (Inflammatory bowel disease, short bowel syndrome etc) K86.81 Insufficiency of the exocrine pancreas K90.x Intestinal malabsorption K74.x Biliary cirrhosis, liver dysfunction N25.0 Renal osteodystrophy N04.x Nephrotic syndrome T42.75x Treatment with anticonvulsant drugs (enhanced metabolism) Reviews, Revisions, and Approvals Date Approval Date Initial policy 12/09 Annual review 2009-2016 annual Added ICD-10 codes 7/17 References 1. Baz-Hecht M, Goldfine A. The impact of vitamin D deficiency on diabetes and cardiovascular risk. Curr Opin Endocrinol Diab Obesity. 2010;17(2):113-119. Page 3 of 5

2. Boyages, S, Bilinski, K. The Vitamin D paradox: Bone density testing in females aged 45 to 74 did not increase over a ten year period despite a marked increase in testing for vitamin D. Journal of endocrinological investigation. 2013 Apr 2. 3. Ferri: Ferri's Clinical Advisor 2013, 1st ed. Laboratory Tests. 2012 Mosby, An Imprint of Elsevier 4. Glendenning P, Inderjeeth CA. Screening for vitamin D deficiency: defining vitamin D deficiency, target thresholds of treatment and estimating the benefits of treatment. Pathology. 2011 Dec 19 5. Hayes. Medical Technology Directory. Vitamin D and Breast Cancer. December 6, 2012. December 12, 2013. Update Nov 2014. Update October 13, 2015. 6. Hayes. Medical Technology Directory. Vitamin D Supplementation in Patients with Osteoporosis. August 27, 2012. Updated September 18, 2013. Update August 2014. Update May 20, 2016. 7. Hendry J. Low Vitamin D Tied to Heart, Stroke Deaths. American Journal of Epidemiology, October 15, 2009. 8. Holick MF, Binkley NC, Bischoff-Ferrari HA, et al. Evaluation, Treatment, and Prevention of Vitamin D Deficiency: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2011 Jul;96(7):1911-30. 9. Institute of Medicine (IOM). Dietary References for Calcium and Vitamin D. Washington D.C.: The National Acadamies Press. 2010. Available at: http://www.iom.edu/reports/2010/dietary-reference-intakes-for-calcium-and-vitamin- D.aspx. 10. Kopes-Kerr, C. Should family physicians routinely screen for vitamin D deficiency? No: screening is unnecessary, and routine supplementation makes more sense. Am Fam Physician. 2013 Apr 15;87(8):od2. 11. Apr;150(3):605-11. doi: 10.1007/s10549-015-3355-x. Epub 2015 Apr 2. 12. Misra M. Vitamin D insufficiency and deficiency in children and adolescents. UpToDate. December 10, 2012. 13. Mow TC, Stokes CM, Sutherland AG. Patients presenting with fractures are likely to be vitamin D deficient: are we getting enough sun? ANZ J Surg. 2015 May 26. doi: 10.1111/ans.13190. 14. Peppone LJ, et al. Vitamin D deficiency prevalent in women being treated for breast cancer; High-dose supplementation can increase vitamin D blood levels. American Society of Clinical Oncology Breast Cancer Symposium, Abstract 211. October 8, 2009. 15. Reid, IR, Bolland, MJ, Grey, A. Effects of vitamin D supplements on bone mineral density: a systematic review and meta-analysis. Lancet. 2013 Oct 10. 16. Schiller A, Gadalean F, Schiller O, et al. Vitamin d deficiency-prognostic marker or mortality risk factor in end stage renal disease patients with diabetes mellitus treated with hemodialysis-a prospective multicenter study. PLoS One. 2015 May 12;10(5):e0126586 17. Shen L, Ji HF. Vitamin D deficiency is associated with increased risk of Alzheimer's disease and dementia: evidence from meta-analysis. England, 2015. p. 76. 18. Tangpricha V. An update on the screening, diagnosis, management, and treatment of vitamin D deficiency in individuals with cystic fibrosis: evidence-based recommendations from the Cystic Fibrosis Foundation. J Clin Endocrinol Metab - 01-APR-2012; 97(4): 1082-93 Page 4 of 5

19. United States Preventive Services Task Force (USPSTF). Vitamin D Deficiency: Screening. Nov. 2014. Available at: http://www.uspreventiveservicestaskforce.org/page/topic/recommendationsummary/vitamin-d-deficiency-screening 20. Villaseñor A, Ballard-Barbash R, Ambs A, et al. Associations of serum 25-hydroxyvitamin D with overall and breast cancer-specific mortality in a multiethnic cohort of breast cancer survivors. Cancer Causes Control. 2013 Apr;24(4):759-67. doi: 10.1007/s10552-013-0158-4. 21. Vitezova A, Cartolano NS, Heeringa J, et al. Vitamin d and the risk of atrial fibrillation - the rotterdam study. PLoS One. 2015 May 1;10(5):e0125161 22. Zeichner SB, Koru-Sengul T, Shah N, et al. Improved clinical outcomes associated with vitamin D supplementation during adjuvant chemotherapy in patients with HER2+ nonmetastatic breast cancer. Clin Breast Cancer. 2015 Feb;15(1):e1-11. doi: 10.1016/j.clbc.2014.08.001. Epub 2014 Aug 15. 23. Zhang Zl, Liao EY, Xia WB, et al. Alendronate sodium/vitamin D3 combination tablet versus calcitriol for osteoporosis in Chinese postmenopausal women: a 6-month, randomized, open-label, active-comparator-controlled study with a 6-month extension. Osteoporos Int. 2015 Sep;26(9):2365-74. doi: 10.1007/s00198-015-3141-y. Epub 2015 May 1. Page 5 of 5