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Asset Publisher
Testing Serum Vitamin D Levels
Policy Number: MP-732
Latest Review Date: January 2024
Category: Laboratory
POLICY:
Effective for dates of service on and after October 16, 2023:
Serum testing of 25-hydroxyvitamin D levels may be considered medically necessary in individuals with a clinically documented underlying disease, condition, or risk factor which is specifically associated with vitamin D deficiency, toxicity, or decreased bone density. These conditions are:
- Biliary cirrhosis and other specified disorders of the biliary tract
- Blind loop syndrome
- Celiac Disease
- Coronary artery disease in individuals where risk of disease progression is being considered against benefits of chronic vitamin D and calcium therapy
- Dermatomyositis
- Hypercalcemia, hypocalcemia or other disorders of calcium metabolism
- Hyperparathyroidism or hypoparathyroidism
- Hypervitaminosis of vitamin D
- Individuals receiving hyperalimentation
- Intestinal malabsorption
- Liver cirrhosis
- Long term use of anticonvulsants, glucocorticoids and other medications known to lower vitamin D levels
- Lymphoma
- Malnutrition (e.g. Cystic Fibrosis)
- Myopathy related to endocrine diseases
- Obesity
- Osteogenesis imperfecta
- Osteomalacia
- Osteopetrosis
- Osteopenia
- Osteoporosis
- Pancreatic steatorrhea
- Primary or miliary tuberculosis
- Psoriasis
- Regional enteritis
- Renal, ureteral or urinary calculus
- Rickets
- Sarcoidosis
- Stage III-V Chronic Kidney Disease and End Stage Renal Disease
- Systemic lupus erythematosus
- Testing for D2 and D3 fractions of 25-hydroxyvitamin D may be considered medically necessary as part of the total 25-hydroxyvitamin D analysis.
- 25-hydroxyvitamin D serum testing is considered not medically necessary for all other medical conditions.
- Repeat testing of serum 25-hydroxyvitamin D levels may be considered medically necessary in individuals who have documented vitamin D deficiency, at least twelve (12) weeks after initiation of vitamin D supplementation therapy.
- Testing of serum 25-hydroxyvitamin D levels more frequently than twice in a rolling twelve (12) month period is considered not medically necessary for any diagnosis other than chronic kidney disease (CKD) or intestinal malabsorption.
Serum testing of 1, 25-dihydroxyvitamin D levels may be considered medically necessary in the evaluation or treatment of conditions that are associated with defects in vitamin D metabolism. These conditions are:
- Disorders of calcium metabolism
- Familial hypophosphatemia
- Fanconi syndrome
- Hyperparathyroidism or hypoparathyroidism
- Individuals receiving hyperalimentation
- Neonatal hypocalcemia
- Osteogenesis imperfecta
- Osteomalacia
- Osteopetrosis
- Primary or miliary tuberculosis
- Renal, ureteral or urinary calculus
- Sarcoidosis
- Stage III-V Chronic Kidney Disease and End Stage Renal Disease
- Vitamin D resistant rickets
- Pseudovitamin D-deficiency rickets
- 1, 25-dihydroxyvitamin D serum testing is considered not medically necessary for all other medical conditions.
25-hydroxyvitamin D and/or 1, 25-dihydroxyvitamin D serum testing for routine screening of vitamin D deficiency is considered not medically necessary.
Both assays of vitamin D need not be performed for each of the above conditions. Often, one type is more appropriate for a certain disease state than another. The most common type of vitamin D deficiency is 25-OH vitamin D. A much smaller percentage of 1, 25-dihydroxy vitamin D deficiency exists; mostly, in those with renal disease.
Effective for dates of service March 1, 2021 through October 15, 2023:
Serum testing of 25-hydroxyvitamin D levels may be considered medically necessary in individuals with a clinically documented underlying disease, condition, or risk factor which is specifically associated with vitamin D deficiency, toxicity, or decreased bone density. These conditions are:
- Biliary cirrhosis and other specified disorders of the biliary tract
- Blind loop syndrome
- Celiac Disease
- Coronary artery disease in individuals where risk of disease progression is being considered against benefits of chronic vitamin D and calcium therapy
- Dermatomyositis
- Hypercalcemia, hypocalcemia or other disorders of calcium metabolism
- Hyperparathyroidism or hypoparathyroidism
- Hypervitaminosis of vitamin D
- Individuals receiving hyperalimentation
- Intestinal malabsorption
- Liver cirrhosis
- Long term use of anticonvulsants, glucocorticoids and other medications known to lower vitamin D levels
- Lymphoma
- Malnutrition (e.g. Cystic Fibrosis)
- Myopathy related to endocrine diseases
- Obesity
- Osteogenesis imperfecta
- Osteomalacia
- Osteopetrosis
- Osteoporosis
- Pancreatic steatorrhea
- Primary or miliary tuberculosis
- Psoriasis
- Regional enteritis
- Renal, ureteral or urinary calculus
- Rickets
- Sarcoidosis
- Stage III-V Chronic Kidney Disease and End Stage Renal Disease
- Systemic lupus erythematosus
- Testing for D2 and D3 fractions of 25-hydroxyvitamin D may be considered medically necessary as part of the total 25-hydroxyvitamin D analysis.
- 25-hydroxyvitamin D serum testing is considered not medically necessary for all other medical conditions.
- Repeat testing of serum 25-hydroxyvitamin D levels may be considered medically necessary in individuals who have documented vitamin D deficiency, at least twelve (12) weeks after initiation of vitamin D supplementation therapy.
- Testing of serum 25-hydroxyvitamin D levels more frequently than twice in a rolling twelve (12) month period is considered not medically necessary for any diagnosis other than chronic kidney disease (CKD) or intestinal malabsorption.
Serum testing of 1, 25-dihydroxyvitamin D levels may be considered medically necessary in the evaluation or treatment of conditions that are associated with defects in vitamin D metabolism. These conditions are:
- Disorders of calcium metabolism
- Familial hypophosphatemia
- Fanconi syndrome
- Hyperparathyroidism or hypoparathyroidism
- Individuals receiving hyperalimentation
- Neonatal hypocalcemia
- Osteogenesis imperfecta
- Osteomalacia
- Osteopetrosis
- Primary or miliary tuberculosis
- Renal, ureteral or urinary calculus
- Sarcoidosis
- Stage III-V Chronic Kidney Disease and End Stage Renal Disease
- Vitamin D resistant rickets
- Pseudovitamin D-deficiency rickets
- 1, 25-dihydroxyvitamin D serum testing is considered not medically necessary for all other medical conditions.
25-hydroxyvitamin D and/or 1, 25-dihydroxyvitamin D serum testing for routine screening of vitamin D deficiency is considered not medically necessary.
Both assays of vitamin D need not be performed for each of the above conditions. Often, one type is more appropriate for a certain disease state than another. The most common type of vitamin D deficiency is 25-OH vitamin D. A much smaller percentage of 1, 25-dihydroxy vitamin D deficiency exists; mostly, in those with renal disease.
Effective for dates of service January 1, 2020 through February 28, 2021:
Serum testing of 25-hydroxyvitamin D levels may be considered medically necessary in individuals with a clinically documented underlying disease, condition, or risk factor which is specifically associated with vitamin D deficiency, toxicity, or decreased bone density. These conditions are:
- Biliary cirrhosis and other specified disorders of the biliary tract
- Blind loop syndrome
- Celiac Disease
- Coronary artery disease in individuals where risk of disease progression is being considered against benefits of chronic vitamin D and calcium therapy
- Dermatomyositis
- Hypercalcemia, hypocalcemia or other disorders of calcium metabolism
- Hyperparathyroidism or hypoparathyroidism
- Hypervitaminosis of vitamin D
- Individuals receiving hyperalimentation
- Intestinal malabsorption
- Liver cirrhosis
- Long term use of anticonvulsants, glucocorticoids and other medications known to lower vitamin D levels
- Lymphoma
- Malnutrition
- Myopathy related to endocrine diseases
- Obesity
- Osteogenesis imperfecta
- Osteomalacia
- Osteopetrosis
- Osteoporosis
- Pancreatic steatorrhea
- Primary or miliary tuberculosis
- Psoriasis
- Regional enteritis
- Renal, ureteral or urinary calculus
- Rickets
- Sarcoidosis
- Stage III-V Chronic Kidney Disease and End Stage Renal Disease
- Systemic lupus erythematosus
- Testing for D2 and D3 fractions of 25-hydroxyvitamin D may be considered medically necessary as part of the total 25-hydroxyvitamin D analysis.
- 25-hydroxyvitamin D serum testing is considered not medically necessary for all other medical conditions.
- Repeat testing of serum 25-hydroxyvitamin D levels may be considered medically necessary in individuals who have documented vitamin D deficiency, at least twelve (12) weeks after initiation of vitamin D supplementation therapy.
- Testing of serum 25-hydroxyvitamin D levels more frequently than twice in a rolling twelve (12) month period is considered not medically necessary for any diagnosis other than chronic kidney disease (CKD) or intestinal malabsorption.
Serum testing of 1, 25-dihydroxyvitamin D levels may be considered medically necessary in the evaluation or treatment of conditions that are associated with defects in vitamin D metabolism. These conditions are:
- Disorders of calcium metabolism
- Familial hypophosphatemia
- Fanconi syndrome
- Hyperparathyroidism or hypoparathyroidism
- Individuals receiving hyperalimentation
- Neonatal hypocalcemia
- Osteogenesis imperfecta
- Osteomalacia
- Osteopetrosis
- Primary or miliary tuberculosis
- Renal, ureteral or urinary calculus
- Sarcoidosis
- Stage III-V Chronic Kidney Disease and End Stage Renal Disease
- Vitamin D resistant rickets
- Pseudovitamin D-deficiency rickets
- 1, 25-dihydroxyvitamin D serum testing is considered not medically necessary for all other medical conditions.
25-hydroxyvitamin D and/or 1, 25-dihydroxyvitamin D serum testing for routine screening of vitamin D deficiency is considered not medically necessary.
Both assays of vitamin D need not be performed for each of the above conditions. Often, one type is more appropriate for a certain disease state than another. The most common type of vitamin D deficiency is 25-OH vitamin D. A much smaller percentage of 1, 25-dihydroxy vitamin D deficiency exists; mostly, in those with renal disease.
DESCRIPTION OF PROCEDURE OR SERVICE:
Vitamin D, also known as calciferol, is a fat-soluble vitamin that has a variety of physiologic effects, most prominently in calcium homeostasis and bone metabolism. In addition to the role it plays in bone metabolism, other physiologic effects include inhibition of smooth muscle proliferation, regulation of the renin-angiotensin system, a decrease in coagulation, and a decrease in inflammatory markers.
Vitamin D
Vitamin D, also known as calciferol, is a fat-soluble vitamin that has a variety of physiologic effects, most prominently in calcium homeostasis and bone metabolism. In addition to the role vitamin D plays in bone metabolism, other physiologic effects include inhibition of smooth muscle proliferation, regulation of the renin-angiotensin system, a decrease in coagulation, and a decrease in inflammatory markers.
Vitamin D Replacement
The Institute of Medicine (now the National Academy of Medicine [NAM]) has recommended reference values for the intake of vitamin D and serum levels, based on available literature and expert consensus. Recommended daily allowances are 600 IU/d for individuals between one and 70 years of age, and 800 IU/d for individuals older than 70 years.
Estimates of vitamin D requirements are complicated by the many other factors that affect serum levels. Sun exposure is the most prominent of factors that affect serum levels, and this is because individuals can meet their vitamin D needs entirely through adequate sun exposure. Other factors such as age, skin pigmentation, obesity, physical activity, and nutritional status also affect vitamin D levels and can result in variable dietary intake requirements to maintain adequate serum levels.
Excessive intake of vitamin D can be toxic. Toxic effects are usually due to hypercalcemia and may include confusion, weakness, polyuria, polydipsia, anorexia, and vomiting. In addition, high levels of vitamin D may promote calcium deposition and have the potential to exacerbate conditions such as calcium kidney stones and atherosclerotic vascular disease.
The Institute of Medicine defined 3 parameters of nutritional needs for vitamin D, on the assumption of minimal sun exposure. These parameters were the estimated average requirement, defined as the minimum intake required to maintain adequate levels; the recommended daily allowance, defined as the optimal dose for replacement therapy; and the upper-level intake, defined as the maximum daily dose to avoid toxicity. These recommendations are summarized in Table 1.
Table 1. Institute of Medicine Recommendations for Vitamin D Dietary Intake
Patient Group |
Estimated Average Requirement, IU/d |
Recommended Daily Allowance, IU/d |
Upper Limit Intake, IU/d |
1 to 3 years of age |
400 |
600 |
2500 |
4 to 8 years of age |
400 |
600 |
3000 |
9 to 70 years of age |
400 |
600 |
4000 |
>70 years of age |
400 |
800 |
4000 |
Adapted from Institute of Medicine (2011).
KEY POINTS:
The most recent literature update was performed through October 16, 2023.
Summary of Evidence
For individuals who are asymptomatic without conditions or risk factors for which vitamin D treatment is recommended who receive testing of vitamin D levels, the evidence includes no randomized controlled trials (RCTs) of clinical utility (i.e., evidence that patient care including testing vitamin D levels versus care without testing vitamin D levels improves outcomes). Relevant outcomes are overall survival, test validity, symptoms, morbid events, and treatment-related morbidity. Indirect evidence of the potential utility of testing includes many RCTs and systematic reviews of vitamin D supplementation. There is a lack of standardized vitamin D testing strategies and cutoffs for vitamin D deficiency are not standardized or evidence-based. In addition, despite the large quantity of evidence, considerable uncertainty remains about the beneficial health effects of vitamin D supplementation. Many RCTs have included participants who were not vitamin D deficient at baseline and did not stratify results by baseline 25-hydroxyvitamin D level. Nonwhite race/ethnic groups are underrepresented in RCTs but have increased risk of vitamin D deficiency. For skeletal health, there may be a small effect of vitamin D supplementation on falls, but there does not appear to be an impact on reducing fractures for the general population. The effect on fracture reduction may be significant in elderly women, and with higher doses of vitamin D. However, high doses of vitamin D may be associated with safety concerns in patients at risk for falls. For patients with asthma, there may be a reduction in severe exacerbations with vitamin D supplementation, but there does not appear to be an effect on other asthma outcomes. For patients who are pregnant, vitamin D supplementation may improve maternal and fetal outcomes. For overall mortality, there is also no benefit to the general population. RCTs evaluating extra skeletal, cancer, cardiovascular, and multiple sclerosis outcomes have not reported a statistically significant benefit for vitamin D supplementation. Although vitamin D toxicity and adverse events appear to be rare, few data on risks have been reported. The evidence is insufficient to determine the effects of the technology on health outcomes.
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. There are no evidence-based clinical practice guidelines that recommend 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 relationship between vitamin D and multiple sclerosis is being explored. Currently, data are mixed regarding the efficacy of vitamin D supplementation on clinical and radiographic outcome measures. To date, studies have been limited by small sample sizes, short durations, and concurrent use of disease modifying therapies, which may have confounded results. Recent meta-anlayses have not clearly identified the benefit of vitamin D in the treatment of multiple sclerosis. Larger studies with longer durations are needed to prove the efficacy of vitamin D supplementation and provide clearer evidence regarding the role of supplement in multiple sclerosis. The impact of vitamin D supplementation on multiple sclerosis activity remains inadequately investigated. At this time, the available well-designed, peer reviewed, scientific evidence is insufficient to prove an increase in net health outcomes for the use of vitamin D supplementation in multiple sclerosis.
Practice Guideline and Position Statements
American College of Obstetrics and Gynecology
The American College of Obstetrics and Gynecology (2011, reaffirmed 2021) issued a committee opinion on the testing of vitamin D levels and vitamin D supplementation in pregnant women. The following recommendation was made concerning testing vitamin D levels:
“At this time there is insufficient evidence to support a recommendation for screening all pregnant women for vitamin D deficiency. For pregnant women thought to be at increased risk of vitamin D deficiency, maternal serum 25-hydroxyvitamin D levels can be considered and should be interpreted in the context of the individual clinical circumstance. When vitamin D deficiency is identified during pregnancy, most experts agree that 1,000-2,000 international units per day of vitamin D is safe.”
Bone Health and Osteoporosis Foundation
The Bone Health and Osteoporosis Foundation updated recommendations for the prevention and treatment of osteoporosis in 2021. They recommended monitoring serum 25-hydroxy vitamin D levels in postmenopausal women and men 50 years of age and older, and vitamin D supplementation as necessary to maintain levels between 30 and 50 ng/mL.
Endocrine Society
In 2011, The Endocrine Society published clinical practice guidelines on the evaluation, treatment, and prevention of vitamin D deficiency. The following recommendations were made regarding testing vitamin D levels:
- 25-hydroxyvitamin D serum level testing is recommended: “to evaluate vitamin D status only in patients who are at risk of deficiency.” The guideline did not recommend screening of individuals not at risk of vitamin D deficiency.
- 1, 25-dihydroxyvitamin D testing was not recommended to evaluate vitamin D status. However, the guideline did recommend monitoring calcitriol levels under certain conditions.
Indications for 25(OH)D measurement (candidates for screening) published by the Endocrine Society are as follows:
- Rickets Osteomalacia Osteoporosis
- Chronic kidney disease Hepatic failure Malabsorption syndromes
- Cystic fibrosis
- Inflammatory bowel disease Crohn’s disease
- Bariatric surgery Radiation enteritis
- Hyperparathyroidism Medications
- Antiseizure medications Glucocorticoids
- AIDS medications
- Antifungals, e.g. ketoconazole Cholestyramine
- African-American and Hispanic children and adults Pregnant and lactating women
- Older adults with history of falls
- Older adults with history of nontraumatic fractures Obese children and adults (BMI > 30 kg/m2)
- Granuloma-forming disorders
- Sarcoidosis Tuberculosis Histoplasmosis Coccidiomycosis Berylliosis
- Some lymphomas
U.S. Preventive Services Task Force Recommendations
The U.S. Preventive Services Task Force published an updated recommendation and associated evidence report and systematic review in 2021 on vitamin D screening. The Task Force concluded that the current evidence was insufficient to assess the balance of benefits and harms of screening for vitamin D deficiency in asymptomatic individuals (grade I [insufficient evidence]).
KEY WORDS:
Vitamin D, calciferol, serum levels, 25-hydroxyvitamin D, hypervitaminosis D, 1, 25-dihydroxyvitamin D
APPROVED BY GOVERNING BODIES:
The U.S. Food and Drug Administration (FDA) has cleared a number of immunoassays for in vitro diagnostic devices for the quantitative measurement of total 25-hydroxyvitamin D through the 510(k) process.
Clinical laboratories may develop and validate tests in-house and market them as a laboratory service; laboratory-developed tests must meet the general regulatory standards of the Clinical Laboratory Improvement Amendments. Lab tests for vitamin D are available under the auspices of the CLIA. Laboratories that offer laboratory-developed tests must be licensed by CLIA for high-complexity testing. To date, the FDA has chosen not to require any regulatory review of this test.
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.
CURRENT CODING:
CPT codes:
0038U |
Vitamin D, 25 hydroxy D2 and D3, by LC-MS/MS, serum microsample, quantitative (Sensieva™ Droplet 25OH Vitamin D2/D3 Microvolume LC/MS Assay) |
82306 |
Vitamin D; 25 hydroxy, includes fraction(s), if performed |
82652 |
Vitamin D; 1, 25 dihydroxy, includes fraction(s), if performed |
REFERENCES:
- American Academy of Family Physicians. Screening for Vitamin D Deficiency in Adults: Recommendation Statement. 2015; http://www.aafp.org/patient-care/clinical-recommendations/all/vitamin-D-deficiency.html.
- American Academy of Family Physicians. Vitamin D Screening and Supplementation in Community-Dwelling Adults: Common Questions and Answers. 2018; https://www.aafp.org/afp/2018/0215/p254.html.
- American College of Obstetrics and Gynecology Committee on Obstetric Practice. ACOG Committee Opinion No. 495: Vitamin D: Screening and supplementation during pregnancy. Obstet Gynecol. Jul 2011; 118(1):197-198.
- Andujar-Espinosa R, Salinero-Gonzalez L, Illan-Gomez F, et al. Effect of vitamin D supplementation on asthma control in patients with vitamin D deficiency: the ACVID randomised clinical trial. Thorax. Feb 2021; 76(2): 126-133.
- Appel LJ, Michos ED, Mitchell CM, et al. The Effects of Four Doses of Vitamin D Supplements on Falls in Older Adults : A Response-Adaptive, Randomized Clinical Trial. Ann Intern Med. Feb 2021; 174(2): 145-156.
- Asemi Z, Samimi M, Tabassi Z, et al. Vitamin D supplementation affects serum high-sensitivity C-reactive protein, insulin resistance, and biomarkers of oxidative stress in pregnant women. J Nutr. Sep 2013; 143(9): 1432-8.
- Aspray TJ, Bowring C, Fraser W, et al. National Osteoporosis Society vitamin D guideline summary. Age Ageing. Sep 2014; 43(5): 592-5.
- Avenell A, Gillespie WJ, Gillespie LD, et al. Vitamin D and vitamin D analogues for preventing fractures associated with involutional and post-menopausal osteoporosis. Cochrane Database Syst Rev. Apr 15 2009(2):CD000227.
- Avenell A, MacLennan GS, Jenkinson DJ, et al. Long-term follow-up for mortality and cancer in a randomized placebo-controlled trial of vitamin D(3) and/or calcium (RECORD trial). J Clin Endocrinol Metab. Feb 2012; 97(2): 614-22.
- Baris S, Kiykim A, Ozen A, et al. Vitamin D as an adjunct to subcutaneous allergen immunotherapy in asthmatic children sensitized to house dust mite. Allergy. Feb 2014; 69(2):246-253.
- Baron JA, Barry EL, Mott LA, et al. A trial of calcium and vitamin D for the prevention of colorectal adenomas. N Engl J Med. Oct 15 2015; 373(16):1519-1530.
- Behjat Sasan S, Zandvakili F, Soufizadeh N, et al. The Effects of Vitamin D Supplement on Prevention of Recurrence of Preeclampsia in Pregnant Women with a History of Preeclampsia. Obstet Gynecol Int. 2017; 2017: 8249264.
- Bischoff-Ferrari HA, Willett WC, Wong JB, et al. Fracture prevention with vitamin D supplementation: a meta-analysis of randomized controlled trials. JAMA. May 11 2005; 293(18):2257-2264.
- Bischoff-Ferrari HA, Willett WC, Wong JB, et al. Prevention of nonvertebral fractures with oral vitamin D and dose dependency: a meta-analysis of randomized controlled trials. Arch Intern Med. Mar 23 2009; 169(6):551-561.
- Bjelakovic G, Gluud LL, Nikolova D, et al. Vitamin D supplementation for prevention of cancer in adults. Cochrane Database Syst Rev. Jun 23 2014(6):CD007469.
- Bjelakovic G, Gluud LL, Nikolova D, et al. Vitamin D supplementation for prevention of mortality in adults. Cochrane Database Syst Rev. Jul 06 2011(7):CD007470.
- Bolland MJ, Avenell A, Baron JA, et al. Effect of calcium supplements on risk of myocardial infarction and cardiovascular events: meta-analysis. BMJ. Jul 29 2010; 341:c3691.
- Bolton-Smith C, McMurdo ME, Paterson CR, et al. Two-year randomized controlled trial of vitamin K1 (phylloquinone) and vitamin D3 plus calcium on the bone health of older women. J Bone Miner Res. Apr 2007; 22(4): 509-19.
- Borsche L, Glauner B, von Mendel J. COVID-19 Mortality Risk Correlates Inversely with Vitamin D3 Status, and a Mortality Rate Close to Zero Could Theoretically Be Achieved at 50 ng/mL 25(OH)D3: Results of a Systematic Review and Meta-Analysis. Nutrients. 2021 Oct 14;13(10):3596.
- Brooke OG, Brown IR, Bone CD, et al. Vitamin D supplements in pregnant Asian women: effects on calcium status and fetal growth. British Medical Journal 1980; 1:751-754.
- Brunner RL, Wactawski-Wende J, Caan BJ, et al. The effect of calcium plus vitamin D on risk for invasive cancer: results of the Women's Health Initiative (WHI) calcium plus vitamin D randomized clinical trial. Nutr Cancer. 2011; 63(6): 827-41.
- Castro M, King TS, Kunselman SJ, et al. Effect of vitamin D3 on asthma treatment failures in adults with symptomatic asthma and lower vitamin D levels: the VIDA randomized clinical trial. Jama. May 2014; 311(20):2083-2091.
- Cauley JA, Lacroix AZ, Wu L, et al. Serum 25-hydroxyvitamin D concentrations and risk for hip fractures. Ann Intern Med. Aug 19 2008; 149(4):242-250.
- Cauley JA, Parimi N, Ensrud KE, et al. Serum 25-hydroxyvitamin D and the risk of hip and nonspine fractures in older men. J Bone Miner Res. Mar 2010; 25(3):545-553.
- Chowdhury R, Kunutsor S, Vitezova A, et al. Vitamin D and risk of cause specific death: systematic review and meta-analysis of observational cohort and randomised intervention studies. BMJ. Apr 01 2014; 348:g1903.
- Chung M, Balk EM, Brendel M, et al. Vitamin D and calcium: a systematic review of health outcomes. Evid Rep Technol Assess (Full Rep). Aug 2009(183):1-420.
- Committee to Review Dietary Reference Intakes for Vitamin D and Calcium, Food and Nutrition Board. Dietary Reference Intakes for Calcium and Vitamin D. Washington, DC: National Academies Press; 2011.
- Cooper C, Harvey NC, Bishop NJ, et al. Maternal gestational vitamin D supplementation and offspring bone health (MAVIDOS): a multicentre, double-blind, randomised placebo-controlled trial. Lancet Diabetes Endocrinol. May 2016; 4(5): 393-402.
- Cranney A, Horsley T, O'Donnell S, et al. Effectiveness and Safety of Vitamin D in Relation to Bone Health (Evidence Reports/Technology Assessments No. 158). Rockville, MD: Agency for Healthcare Research and Quality; 2011.
- Daly RM, Petrass N, Bass S, et al. The skeletal benefits of calcium- and vitamin D3-fortified milk are sustained in older men after withdrawal of supplementation: an 18-mo follow-up study. Am J Clin Nutr. Mar 2008; 87(3): 771-7.
- de Groot JC, van Roon EN, Storm H, et al. Vitamin D reduces eosinophilic airway inflammation in nonatopic asthma. J Allergy Clin Immunol. Mar 2015; 135(3):670-675.e673.
- Delvin EE, Salle BL, Glorieux FH, et al. Vitamin D supplementation during pregnancy: effect on neonatal calcium homeostasis. J Pediatr. Aug 1986; 109(2): 328-34.
- DEQAS (Vitamin D External Quality Assurance Scheme). n.d.; http://www.deqas.org/.
- Dodamani MH, Muthu V, Thakur R, et al. A randomised trial of vitamin D in acute-stage allergic bronchopulmonary aspergillosis complicating asthma. Mycoses. Apr 2019; 62(4): 320-327.
- Elamin MB, Abu Elnour NO, Elamin KB, et al. Vitamin D and cardiovascular outcomes: a systematic review and meta-analysis. J Clin Endocrinol Metab. Jul 2011; 96(7):1931-1942.
- Fu J, Sun J, Zhang C. Vitamin D supplementation and risk of stroke: A meta-analysis of randomized controlled trials. Front Neurol. 2022; 13: 970111.
- Gallagher JC, Fowler SE, Detter JR, et al. Combination treatment with estrogen and calcitriol in the prevention of age-related bone loss. J Clin Endocrinol Metab. Aug 2001; 86(8): 3618-28.
- Glendenning P, Zhu K, Inderjeeth C, et al. Effects of three-monthly oral 150,000 IU cholecalciferol supplementation on falls, mobility, and muscle strength in older postmenopausal women: a randomized controlled trial. J Bone Miner Res. Jan 2012; 27(1): 170-6.
- Grady D, Halloran B, Cummings S, et al. 1, 25-Dihydroxyvitamin D3 and muscle strength in the elderly: a randomized controlled trial. J Clin Endocrinol Metab. Nov 1991; 73(5): 1111-7.
- Grant CC, Stewart AW, Scragg R, et al. Vitamin D during pregnancy and infancy and infant serum 25-hydroxyvitamin D concentration. Pediatrics. Jan 2014; 133(1): e143-53.
- Herrick KA, Storandt RJ, Afful J, et al. Vitamin D status in the United States, 2011-2014. Am J Clin Nutr. Jul 01 2019; 110(1): 150-157.
- 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. Jul 2011; 96(7):1911-1930.
- Holvik K, Ahmed LA, Forsmo S, et al. Low serum levels of 25-hydroxyvitamin D predict hip fracture in the elderly: a NOREPOS study. J Clin Endocrinol Metab. Aug 2013; 98(8):3341-3350.
- IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
- Jackson RD, LaCroix AZ, Gass M, et al. Calcium plus vitamin D supplementation and the risk of fractures. N Engl J Med. Feb 16 2006; 354(7):669-683.
- Jagannath VA, Fedorowicz Z, Asokan GV, et al. Vitamin D for the management of multiple sclerosis. Cochrane Database Syst Rev. Dec 08 2010(12):CD008422.
- James E, Dobson R, Kuhle J, et al. The effect of vitamin D-related interventions on multiple sclerosis relapses: a meta-analysis. Mult Scler. Oct 2013; 19(12):1571-1579.
- Janssen HC, Samson MM, Verhaar HJ. Muscle strength and mobility in vitamin D-insufficient female geriatric patients: a randomized controlled trial on vitamin D and calcium supplementation. Aging Clin Exp Res. Feb 2010; 22(1): 78-84.
- Jat KR, Goel N, Gupta N, et al. Efficacy of vitamin D supplementation in asthmatic children with vitamin D deficiency: A randomized controlled trial (ESDAC trial). Pediatr Allergy Immunol. Apr 2021; 32(3): 479-488.
- Jensen ME, Mailhot G, Alos N, et al. Vitamin D intervention in preschoolers with viral-induced asthma (DIVA): a pilot randomized controlled trial. Trials. Jul 26 2016; 17(1):353.
- Jia X, Aucott LS, McNeill G. Nutritional status and subsequent all-cause mortality in men and women aged 75 years or over living in the community. Br J Nutr. Sep 2007; 98(3):593-599.
- Jolliffe DA, Greenberg L, Hooper RL, et al. Vitamin D supplementation to prevent asthma exacerbations: a systematic review and meta-analysis of individual participant data. Lancet Respir Med. Oct 03 2017.
- Jorde R, Sollid ST, Svartberg J, et al. Vitamin D 20,000 IU per Week for Five Years Does Not Prevent Progression From Prediabetes to Diabetes. J Clin Endocrinol Metab. Apr 2016; 101(4): 1647-55.
- Judge J, Birge S, Gloth F, et al. Recommendations abstracted from the American Geriatrics Society Consensus Statement on vitamin D for Prevention of Falls and Their Consequences. J Am Geriatr Soc. Jan 2014; 62(1): 147-52.
- Kahwati LC, LeBlanc E, Weber RP, et al. Screening for Vitamin D Deficiency in Adults: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. Apr 13 2021; 325(14): 1443-1463.
- Kaur J, Marya RK, Rathee S, lal H, Singh GP. Effect of pharmacological doses of vitamin D during pregnancy on placental protein status and birth weight. Nutrition Research. 1991; 11(9):1077-1081.
- Kerley CP, Hutchinson K, Cormican L, et al. Vitamin D3 for uncontrolled childhood asthma: A pilot study. Pediatr Allergy Immunol. Jun 2016; 27(4):404-412.
- Keum N, Lee DH, Greenwood DC, et al. Vitamin D supplementation and total cancer incidence and mortality: a meta-analysis of randomized controlled trials. Ann Oncol. May 01 2019; 30(5): 733-743.
- Khan F. A randomized controlled trial of oral vitamin D supplementation in pregnancy to improve maternal periodontal health and birth weight. Journal of International Oral Health 2016; 8(6):657-65.
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- Krist AH, Davidson KW, Mangione CM, et al. Screening for Vitamin D Deficiency in Adults: US Preventive Services Task Force Recommendation Statement. JAMA. Apr 13 2021; 325(14): 1436-1442.
- LaCroix AZ, Kotchen J, Anderson G, et al. Calcium plus vitamin D supplementation and mortality in postmenopausal women: the Women's Health Initiative calcium-vitamin D randomized controlled trial. J Gerontol A Biol Sci Med Sci. May 2009; 64(5): 559-67.
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- Lappe JM, Travers-Gustafson D, Davies KM, et al. Vitamin D and calcium supplementation reduces cancer risk: results of a randomized trial. Am J Clin Nutr. Jun 2007; 85(6): 1586-91.
- Larsen T, Mose FH, Bech JN, et al. Effect of cholecalciferol supplementation during winter months in patients with hypertension: a randomized, placebo-controlled trial. Am J Hypertens. Nov 2012; 25(11): 1215-22.
- LeBlanc ES, Chou R, Pappas M. Screening for vitamin D deficiency. Ann Intern Med. May 19 2015; 162(10):738.
- LeBlanc ES, Zakher B, Daeges M, et al. Screening for vitamin D deficiency: a systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. Jan 20 2015; 162(2):109-122.
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- LeFevre ML, U.S. Preventive Services Task Force. Screening for vitamin D deficiency in adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. Jan 20 2015; 162(2):133-140.
- Lewis E, Fernandez C, Nella A, et al. Relationship of 25-hydroxyvitamin D and asthma control in children. Ann Allergy Asthma Immunol. Apr 2012; 108(4):281-282.
- Ling Y, Xu F, Xia X, et al. Vitamin D supplementation reduces the risk of fall in the vitamin D deficient elderly: An updated meta-analysis. Clin Nutr. 2021; 40(11):5531-5537.
- Litonjua AA, Carey VJ, Laranjo N, et al. Effect of prenatal supplementation with vitamin D on asthma or recurrent wheezing in offspring by age 3 years: the VDAART randomized clinical trial. JAMA. Jan 26 2016; 315(4):362-370.
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- Majak P, Rychlik B, Stelmach I. The effect of oral steroids with and without vitamin D3 on early efficacy of immunotherapy in asthmatic children. Clin Exp Allergy. Dec 2009; 39(12):1830-1841.
- Mallet E, Gugi B, Brunelle P, et al. Vitamin D supplementation in pregnancy: a controlled trial of two methods. Obstet Gynecol. Sep 1986; 68(3): 300-4.
- Manson JE, Brannon PM, Rosen CJ, et al. Vitamin D deficiency - Is there really a pandemic? N Engl J Med. 2016; 375(19):1817-1820.
- Margolis KL, Ray RM, Van Horn L, et al. Effect of calcium and vitamin D supplementation on blood pressure: the Women's Health Initiative Randomized Trial. Hypertension. Nov 2008; 52(5):847-855.
- Martineau AR, Cates CJ, Urashima M, et al. Vitamin D for the management of asthma. Cochrane Database Syst Rev. Sep 05 2016; 9:Cd011511.
- Martineau AR, MacLaughlin BD, Hooper RL, et al. Double-blind randomised placebo-controlled trial of bolus-dose vitamin D3 supplementation in adults with asthma (ViDiAs). Thorax. May 2015; 70(5):451-457.
- Marya RK, Rathee S, Dua V, et al. Effect of vitamin D supplementation during pregnancy on foetal growth. Indian J Med Res. Dec 1988; 88: 488-92.
- Mirghafourvand M, Mohammad-Alizadeh-Charandabi S, Mansouri A, Najafi M, Khodabande F. The effect of vitamin D and calcium plus vitamin D on sleep quality in pregnant women with leg cramps: A controlled randomized clinical trial. Journal of Isfahan Medical School. 2015; 32(320):2444-2453.
- Mithal A, Wahl DA, Bonjour JP, et al. Global vitamin D status and determinants of hypovitaminosis D. Osteoporos Int. Nov 2009;20(11):1807-1820.
- Murdoch DR, Slow S, Chambers ST, et al. Effect of vitamin D3 supplementation on upper respiratory tract infections in healthy adults: the VIDARIS randomized controlled trial. JAMA. Oct 03 2012; 308(13): 1333-9.
- Musharraf MU, Sandhu GA, Mumtaz MU, Rashid MF. Role of vitamin D in prevention of acute exacerbation of bronchial asthma in adults. J Postgrad Med Inst. 2017;31:3103.
- Naghshineh E, Sheikhaliyan S. Effect of vitamin D supplementation in the reduce risk of preeclampsia in nulliparous women. Adv Biomed Res. 2016; 5: 7.
- Newberry SJ, Chung M, Shekelle PG, et al. Vitamin D and Calcium: A Systematic Review of Health Outcomes (Update). Evidence Report/Technology Assessment No. 217. Rockville, MD: Agency for Healthcare Research and Quality; 2014.
- Ott SM, Chesnut CH. Calcitriol treatment is not effective in postmenopausal osteoporosis. Ann Intern Med. Feb 15 1989; 110(4): 267-74.
- Palacios C, Kostiuk LK, Pena-Rosas JP. Vitamin D supplementation for women during pregnancy. Cochrane Database Syst Rev. Jul 26 2019; 7: CD008873.
- Palmer SC, McGregor DO, Craig JC, et al. Vitamin D compounds for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. Oct 07 2009(4): CD005633
- Pilz S, Zittermann A, Trummer C, Theiler-Schwetz V, Lerchbaum E, Keppel MH, Grübler MR, März W, Pandis M. Vitamin D testing and treatment: a narrative review of current evidence. Endocr Connect. 2019 Feb 1;8(2):R27-R43.
- Pittas AG, Chung M, Trikalinos T, et al. Systematic review: Vitamin D and cardiometabolic outcomes. Ann Intern Med. Mar 2 2010; 152(5):307-314.
- Pozuelo-Moyano B, Benito-Leon J, Mitchell AJ, et al. A systematic review of randomized, double-blind, placebo-controlled trials examining the clinical efficacy of vitamin D in multiple sclerosis. Neuroepidemiology. Dec 2013; 40(3):147-153.
- Prince RL, Austin N, Devine A, et al. Effects of ergocalciferol added to calcium on the risk of falls in elderly high-risk women. Arch Intern Med. Jan 14 2008; 168(1): 103-8.
- Rodda CP, Benson JE, Vincent AJ, et al. Maternal vitamin D supplementation during pregnancy prevents vitamin D deficiency in the newborn: an open-label randomized controlled trial. Clin Endocrinol (Oxf). Sep 2015; 83(3): 363-8.
- Roth DE, Al Mahmud A, Raqib R, et al. Randomized placebo-controlled trial of high-dose prenatal third-trimester vitamin D3 supplementation in Bangladesh: the AViDD trial. Nutr J. Apr 12 2013; 12: 47.
- Sabet Z, Ghazi AA, Tohidi M, Oladi B. Vitamin D supplementation in pregnant Iranian women: Effects on maternal and neonatal vitamin D and parathyroid hormone status. Acta Endocrinologica. 2012; 8(1):59-66.
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- Sanders KM, Stuart AL, Williamson EJ, et al. Annual high-dose oral vitamin D and falls and fractures in older women: a randomized controlled trial. JAMA. May 12 2010; 303(18):1815-1822.
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POLICY HISTORY:
Medical Policy Group, November 2019 (9): New policy
Medical Policy Administration Committee, December 2019
Available for comment November 18, 2019 through January 2, 2020.
Medical Policy Panel, December 2020
Medical Policy Group, December 2020 (9): 2020 Updates to Key Points, Description, References. No change to policy statement.
Medical Policy Group, February 2021 (9): Added indication for coverage in Cystic Fibrosis to policy statement. Other portions of policy section updated to remove not medically necessary from statement, no change to other portions of policy section intent.
Medical Policy Administration Committee, February 2021
Available for comment February 16, 2021 through April 2, 2021
Medical Policy Group, December 2021 (9): 2021 Updates to Key Points, Description, References. No change to policy statement.
Medical Policy Panel, March 2022
Medical Policy Group, March 2022 (9): Updates to References. No change to policy statement.
Medical Policy Group, November 2022 (9): Updates to Key Points, References, Practice Guidelines and Position Statements. No change to policy statement.
Medical Policy Panel, December 2022
Medical Policy Group, December 2022 (9): 2022 Updates to Key Points, Description, References. Replaces word "patient" with "individual" in policy statement; no change to policy intent.
Medical Policy Group, September 2023 (5): Policy Statement updated to include Osteopenia to list of medically necessary conditions for serum testing of 25-hydroxyvitamin D levels.
Medical Policy Administration Committee, August 2023
Available for comment September 1, 2023 through October 16, 2023.
Medical Policy Panel, December 2023
Medical Policy Group, January 2024 (5): Updates to Description, Key Points; Practice Guidelines and Position Statements, Benefit Application, and References. No change to Policy Statement.
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.