Medical Policy: 02.04.34
Original Effective Date: November 2011
Reviewed: March 2016
Revised: March 2016
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.
The term, vitamin D, is broad and includes several metabolically interrelated sterol substances that have hormonal activity. Vitamin D has 2 distinctive forms: Vitamin D2 and Vitamin D3.
Vitamin D’s chief biologic function is to maintain serum calcium and phosphorus concentrations within normal range by means of enhancing intestinal absorption of calcium and release of calcium and phosphorus from bone.
25 hydroxyvitamin D [25(OH)D] has a half-life of 2-3 weeks and is the substance measured to assess nutritional adequacy most accurately. It is decreased in dietary vitamin D deficiency, liver disease, malabsorption, inadequate sun exposure, and nephrotic syndrome.
While 1,25-dihydroxy vitamin D is the most potent vitamin D metabolite, levels of the 25-OH forms of vitamin D more accurately reflect the body's vitamin D stores. Consequently, 25HDN / 25-Hydroxyvitamin D2 and D3 (cpt code 82306), Serum is the preferred initial test for assessing vitamin D status. However, in the presence of renal disease, 1,25-dihydroxy vitamin D levels (cpt code 82652) may be needed to adequately assess vitamin D status.
Optimal serum concentrations of 25(OH)D for bone and general health have not been established; they are likely to vary at each stage of life, depending on the physiological measures selected. Also, while serum 25(OH)D functions as a biomarker of exposure to vitamin D (from sun, food, and dietary supplements), the extent to which such levels serve as a biomarker of effect (i.e. health outcomes) is not clearly established. Perhaps most important, even if you have a “low” vitamin D level there is limited evidence in published literature that taking a vitamin D supplement will improve health outcomes.
The Endocrine Society clinical practice guideline recommends screening for vitamin D deficiency in individuals at risk for deficiency. The task force does not recommend population screening for vitamin D deficiency in individuals who are not at risk. Information published in 2013 via the Choosing Wisely campaign: Don’t routinely measure 1,25-dihydroxyvitamin D unless the patient has hypercalcemia or decreased kidney function. Serum levels of 1,25-dihyroxyvitamin D have little or no relationship to vitamin D stores but rather are regulated primarily by parathyroid hormone levels, which in turn are regulated by calcium and/or vitamin D. In vitamin D deficiency, 1,25-dihydroxyvitamin D levels go up, not down.
Unregulated production of 1,25-dihydroxyvitamin D (i.e., sarcoidosis, granulomatous diseases) is an uncommon cause of hypercalcemia; this should be suspected if blood calcium levels are high and parathyroid hormone levels are low and confirmed by measurement of 1,25-dihydroxyvitamin D. The enzyme that activates vitamin D is produced in the kidney, so blood levels of 1,25-dihydroxyvitamin D are sometimes of interest in patients on dialysis or with end-stage kidney disease. There are few other circumstances, if any, where 1,25-dihydroxyvitamin D testing would be helpful.
United States Preventative Services Task Force
The effect of vitamin D levels on health outcomes is difficult to evaluate. Lower vitamin D levels have been reported to increase risk for fractures, falls, functional limitations, some types of cancer, diabetes, cardiovascular disease, depression, and death. However, observations of these associations are inconsistent and may vary by the cut point used to define low vitamin D levels and by subpopulation.
The USPSTF 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.
Vitamin D Testing Protocol published by the Medical Services Commission
Measuring serum vitamin D as 1,25-dihydroxyvitamin D [1,25-(OH)2-D] is seldom indicated, except in selected patients with advanced renal failure, mineral and/or bone diseases. Specialist consultation should be considered for patients with malabsorption, unexplained bone pain, unusual fractures or other evidence suggesting metabolic bone disorder.
Vitamin D Supplementation without Testing
Because vitamin D supplementation in the general adult population is safe, it is reasonable to advise supplementation without testing. Routine testing of vitamin D levels [25-hydroxyvitamin D or 25(OH)D] is not medically necessary prior to or after starting vitamin D supplementation.
Centers for Medicare and Medicaid Services
Guidelines for vitamin D intake and supplementation should be followed for asymptomatic, at-risk individuals such as elderly or infirm patients, or those who are believed to receive inadequate sun exposure. Baseline and/or follow-up vitamin D testing is unnecessary in this group.
American Society for Clinical Pathology via the Choosing Wisely campaign and published in 2013: Vitamin D deficiency is common in many populations, particularly in patients at higher latitudes, during winter months and in those with limited sun exposure. Over the counter Vitamin D supplements and increased summer sun exposure are sufficient for most otherwise healthy patients. Laboratory testing is appropriate in higher risk patients when results will be used to institute more aggressive therapy.
Routine testing of vitamin D levels [25-hydroxyvitamin D or 25(OH)D] is not medically necessary prior to or after starting vitamin D supplementation. Except in the small population where due to absorption or excretion problems general supplementation guidelines would pose a health risk.
25-hydroxyvitamin D [25(OH)D] serum testing may be considered medically necessary in patients with a clinically documented underlying disease or condition which is specifically associated with vitamin D deficiency (where monitoring plays a role in halting disease progression), toxicity, or decreased bone density/osteoporosis.
- Malabsorption Syndromes (Cystic Fibrosis, Celiac Disease, Bariatric Surgery)
- Chronic Kidney Disease Stage III or greater
- Osteogenesis Imperfecta
- Systemic lupus erythematosus
- Granuloma forming Disorders (Sarcoidosis, Tuberculosis)
- Glycogen storage disease
Testing and screening for vitamin D deficiency with 1,25 dihydroxyvitamin D [1,25(OH)2D] serum testing and 25-hydroxyvitamin D [25(OH)D] serum testing is considered not medically necessary for all other indications.
Other than in very complex cases (e.g. hypercalcemia with reportedly low endogenous levels of25-hydroxy vitamin D), there are rarely indications for ordering both 25-hydroxy vitamin D and1,25-dihydroxy vitamin D on the same specimen at the same time.
While the serum concentration of 25-hydroxyvitamin D [25(OH)D] is established as the best indicator of vitamin D status, there is significant uncertainty associated with its measurement. Tests that measure serum levels of 25-hydroxyvitamin D [25OH)D] are not standardized. Serum concentrations that define deficient or insufficient, adequate, and optimal levels of 25-hydroxyvitamin D [25(OH)] are not clearly established. Proposed cutoff points vary widely, leading to inconsistent endorsement among practitioners. It is unclear how vitamin D test results can be used to guide treatment decisions compared to decisions that would be made in the absence of test results, particularly in asymptomatic individuals who are being advised to take vitamin D for their overall wellness, or for those with a condition for which the role of vitamin D has not been clearly defined.
Although vitamin D deficiency is prevalent, measurement of serum 25(OH)D levels is expensive, and universal screening is not supported. However, vitamin D testing may benefit those at risk for severe deficiency or those with laboratory or radiographic findings commonly associated with vitamin D deficiency in these patients, knowledge of the 25(OH)D blood level provides an accurate assessment of vitamin D body stores, helps identify the need for vitamin D therapy, and may help to determine an effective dose.
Presently, no evidence-based clinical practice guideline recommends vitamin D screening of persons without a clinically documented underlying disease or condition which is specifically associated with the risk of decreased bone density or osteoporosis. The role of vitamin D has recently received considerable media attention for a number of indications other than bone health, including cardiovascular disease and hypertension, diabetes and metabolic syndrome, colon, prostate, and breast cancer, reproductive health, immune function, and neuropsychological function. It is not known how or why vitamin D impacts the risk of developing any of these conditions, or whether altering exposure to vitamin D provides a protective effect. Large, randomized, controlled trials will be required to identify the role of vitamin D in these and other conditions to determine if low vitamin D levels are part of pathogenesis or just a marker for a corresponding non-skeletal condition.
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
- 82306 Vitamin D; 25 hydroxy, includes fraction(s), if performed
- 82652 Vitamin D; 1,25 dihydroxy, includes fraction(s), if performed
- Agency for Healthcare Research and Quality. Effectiveness and Safety of Vitamin D in Relation to Bone Health. Evaluation report. 2007.
- Institute of Medicine of the National Academies. Dietary Reference Intakes for Calcium and Vitamin D. November 2010.
- Rosen CJ. Vitamin D Insufficiency. N Engl J Med 2011; 364(3):248-54.
- Binkley N, Krueger DC, Morgan S et al. Current Status of Clinical 25-hydroxyvitamin D Measurement: An Assessment of Between-Laboratory Agreement. Clin Chim Acta. 2010 December 14;411(23-24):1976-82. doi: 10.1016/j.cca.2010.08.018.
- Norman AW, Bouillon R, Whiting SJ et al. 13th Workshop Consensus for Vitamin D Nutritional Guidelines. J Steroid Biochem Mol Biol. 2007 March; 103(3-5):204-5.
- National Institutes of Health Office of Dietary Supplements. Dietary Supplement fact Sheet: Vitamin D. Updated 2/25/2011.
- Motiwala SR, Wang TJ. Vitamin D and cardiovascular disease. Curr Opin Nephrol Hypertens 2011 Apr 23. [Epub ahead of print].
- Fang F, Kasperzyk JL, Shui I et al. Prediagnostic plasma vitamin D metabolites and mortality among patients with prostate cancer. PLoS ONE 6(4):e18625. doi: 10.1371/journal.pone.0018625
- Rajakamur K, de Las Heras J, Chen TC et al. Vitamin d status, adiposity, and lipids in black american and caucasian children. J Clin Endocrinol Metab. 2011 May;96(5):1560-7. Epub 2011 Mar 2.
- Patel R, Rizvi A. Vitamin D deficiency in patients with congestive heart failure: mechanisms, manifestations, and management. May 2011;104(5):325-30. doi: 10.1097/SMJ.obo13e318213cf6b.
- Melamed ML, Michos ED, Post W et al. 25-hydroxyvitamin D levels and the risk of mortality in the general population. Arch Intern Med 2008 Aug 11;168(15):1629-37.
- Hollis BW. Assessment and Interpretation of Circulating 25-Hydroxyvitamin D and 1,25-Dihydroxyvitamin D in the clinical environment. Endocrinol Metab Clin N Am.2010 June;39(2):271-86. doi:10.1016/j.ecl.2010.02.012.
- Hanley DA, Cranney A, Jones G et al. Vitamin D in adult health and disease: a review and guideline statement from Osteoporosis Canada (summary). CMAJ Sep 7 2010;182(12):1315-19. doi: 10.1503/cmaj.091062.
- Holick MF, Binkley NC, Bischoff-Ferrari, et al. Evaluation, Treatment, and Prevention of Vitamin D Deficiency: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2011 July;96(7):1911-1930.
- Kennel K, Drake M, Hurley D. Vitamin D deficiency in adults: when to test and how to treat. Mayo Clinical Procedures. 2010 Aug 85(8) PMC2912737
- Institute of Medicine of the National Academies, Dietary Reference Intakes for Calcium and Vitamin D. November 2010. Available at URL address: http://www.iom.edu/Reports/2010/Dietary-Reference-Intakes-for-Calcium-and-Vitamin-D.aspx
- Medical Services Commission. Vitamin D testing protocol. Victoria (BC): British Columbia Medical Services Commission; 2010 Oct 1. 6 p
- LeFevre ML; US Preventive Services Task Force. Screening for vitamin D deficiency in adults: US Preventive Services Task Force recommendation statement. Ann Intern Med. 2015;162(2):133-140.
- Moyer VA; US Preventive Services Task Force. Vitamin, mineral, and multivitamin supplements for the primary prevention of cardiovascular disease and cancer: US Preventive Services Task Force recommendation statement. Ann Intern Med. 2014;160(8):558-564.
- Heaney RP, Armas LA. Screening for vitamin D deficiency: is the goal disease prevention or full nutrient repletion? Ann Intern Med. 2015;162(2):144-145.
- Manson JE, Bassuk SS. Vitamin D research and Clinical Practice. JAMA. Published online February 19, 2015. doi:10.1001/jama.2015.1353.
- American Society for Clinical Pathology. Ten things physicians and patients should question, Choosing Wisely. Released February 21, 2013. Available at: http://www.choosingwisely.org/societies/american-society-for-clinical-pathology/
- Endocrine Society. Choosing Wisely. Released October 16, 2013. Available at: http://www.choosingwisely.org/clinician-lists/endocrine-society-vitamin-d-testing/
Date Reason Action
May 2011 Literature review New policy
March 2012 Annual review Policy renewed
March 2013 Annual review Policy renewed
March 2014 Annual review Policy revised
March 2015 Annual review Policy revised
July 2015 Interim review Policy revised
January 2016 Interim review Policy revised
March 2016 Annual review Policy revised
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*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.