Clinical UM Guideline

This document addresses testing of serum vitamin D levels in adults and children. Vitamin D testing is a blood test which can aid in the identification and clinical management of individuals at-risk for vitamin D deficiency.

Medically Necessary:

Vitamin D testing is considered medically necessary in individuals with conditions considered high-risk for vitamin D deficiency or intoxication, including but not limited to:

1. Aggressive sun protection measures (that is, limited effective sun exposure due to protective clothing or consistent use of sunscreens); or
2. Amenorrhea in adolescents; or
3. Chronic kidney disease; or
4. Chronic use of select medication regimens (for example, anti-seizure medications, glucocorticoids, anti-retrovirals, and antifungals); or
5. Community-dwelling adults age 65 years or older; or
6. Darker pigmented skin; or
7. Diet limitations such as vegan/macrobiotic; or
8. Diseases associated with malabsorption (for example, cystic fibrosis, inflammatory bowel disease, Crohn’s disease, celiac disease, bariatric surgery, chronic pancreatitis, and radiation enteritis); or
9. Granuloma-forming disorders (for example, sarcoidosis, tuberculosis, histoplasmosis, coccidioidomycosis, and berylliosis); or
10. Hepatic failure (cirrhosis or chronic liver disease); or
11. Hypo- or hyper-calcemia; or
12. Immobilization (for example, cerebral palsy or neuromuscular disease); or
13. Inherited disorders of vitamin D and phosphate metabolism; or
14. Living in an area considered high risk (for example, higher latitudes during winter/spring season, pollution, and cloud cover); or
15. Lymphomas with activated macrophages; or
16. Nutritional rickets; or
17. Older adults with a history of fall or nontraumatic fractures; or
18. Osteomalacia; or
19. Osteopenia; or
20. Osteoporosis; or
21. Parathyroid disorders (for example, hyperparathyroidism); or
22. Pregnancy in women at increased risk of vitamin D deficiency (for example, vegetarians; women with limited sun exposure who may reside in cold climates or northern latitudes, or who wear sun and winter protective clothing; and ethnic minorities, especially those with darker skin); or
23. Prolonged breast-feeding infant 6 months, or older, without appropriate complementary feeding; or
24. Previously documented vitamin D deficiency; or
25. Severe obesity (> 95th percent body mass index for age and gender); or
26. Significantly limited outdoor activities (for example, those who are institutionalized or the elderly); or
27. Signs or symptoms of vitamin D deficiency or intoxication.

Not Medically Necessary:

Vitamin D testing is considered not medically necessary when the criteria above are not met, and for all other indications, including as a screening test in individuals with no known signs or symptoms of vitamin D deficiency or intoxication.

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Medically Necessary:
When the code describes a procedure specified in the Clinical Indications section as not medically necessary.

When services may be Medically Necessary when criteria are met:
For the procedure codes listed above for all other diagnoses not listed.

When services are Not Medically Necessary:
When the code describes a procedure specified in the Clinical Indications section as not medically necessary.

Summary

There are a number of conditions that could place individuals at risk for development of vitamin D deficiency and merit testing of vitamin D levels for diagnosis and ongoing management. However, based on the current evidence and consensus recommendations, screening for vitamin D deficiency in average-risk, asymptomatic children and adults, including pregnant women with no other risk factors, is not routinely recommended.

Discussion

Vitamin D is normally an endogenously produced, fat-soluble vitamin; endogenous synthesis is prompted by ultraviolet rays on the skin which triggers synthesis of this essential vitamin. Vitamin D is also naturally present in small quantities in a limited number of foods and is available as a dietary supplement. Whether obtained from food, supplements, or exposure to ultraviolet rays, vitamin D must undergo further synthesis in the liver and kidneys to be converted from an inert form to an activated form useful for the body’s vital functions, which include, aiding in calcium absorption for bone strengthening, modulation of cell growth, and neuromuscular and immune processes. Due to the complexity in the synthesis of vitamin D, there are poorly defined standards in the medical community regarding the best laboratory measurement cut-offs for defining and diagnosing vitamin D deficiency. For instance, measurement of 1,25-dihydroxyvitamin, or calcitriol (produced by the kidneys), is commonplace for vitamin D deficiency testing; however, it is a poor indictor due to its efficient regulation by other vitamin and hormone levels as well as its relatively short half-life (15 hours). Generally, calcitriol levels do not decrease markedly unless an individual has a severe deficiency in vitamin D. Conversely, serum measurement of 25-hydroxyvitamin D (25[OH]D), or calcidiol (produced by the liver), is a much more reliable indicator of vitamin D status. Although levels of calcidiol also do not correlate significantly with vitamin D stores, it is a reflection of serum circulating levels of cutaneously produced and ingested vitamin D with a half-life averaging 15 days. Unfortunately, there is considerable disagreement regarding the serum levels of calcidiol (25[OH]D) that are indicative of deficiency warranting intervention, such as dietary supplementation. Further complicating medical management of vitamin D deficiency is the wide variability that exists in laboratory analysis methods. There are health risks associated with excessive vitamin D levels and vitamin D toxicity, such as anorexia, weight loss, polyuria, kidney stones, and heart arrhythmias. Toxicity is most likely to result from over-supplementation (National Institutes of Health [NIH], 2016).

Vitamin D Testing and Screening

Despite uncertainty that remains in clinical practice regarding both the clinical benefit of vitamin D serum testing, as well as the definition of vitamin D deficiency, screening of asymptomatic, average-risk individuals remains commonplace. A study evaluating data from the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey found that diagnosis of vitamin D deficiency more than tripled between 2008 and 2010 (383 in 2008 vs. 1177 visits per 100,000 population in 2010; Huang, 2014). According to the American College of Obstetrics and Gynecology ([ACOG], 2011) and World Health Organization (WHO) guidelines (2012) it is not recommended to routinely screen pregnant women for vitamin D deficiency or supplement pregnant woman with vitamin D during pregnancy. According to ACOG, individuals considered at risk include, but are not limited to, vegetarians, menstruating individuals with limited sun exposure (e.g., those who live in cold climates, reside in northern latitudes, or wear sun and winter protective clothing, and individuals with darker skin). Vitamin D levels should always be considered and interpreted in the context of the individual clinical circumstance. The U.S. Preventive Services Task Force (USPSTF) published a consensus statement (2015) regarding screening for vitamin D deficiency in adults. A relevant finding in the USPSTF statement, was that when total 25(OH)D levels are used to define vitamin D deficiency, Black individuals have a two to nine times greater risk for deficiency and Hispanics a two to three times greater risk, relative to their white counterparts. Although further research is needed to determine how the aforementioned deficiencies correlate with clinical health outcomes (such as, bone density and fracture risk), darker pigmentation is an established risk-factor for vitamin D deficiency. According to the Endocrine Society’s  recommendations, infants who may be at risk for vitamin D deficiency include those who are breast-fed without vitamin D supplementation, have darker pigmented skin, and those with maternal vitamin D deficiency. Adults may be at higher risk for vitamin D deficiency if their outdoor activities are greatly limited (for example, those who are institutionalized or the elderly), if they practice aggressive sun protection measures or if living in an area considered high risk. Pregnancy, lactation, obesity and certain medication regimens are additional circumstances that may place individuals at high risk for vitamin D deficiency and may warrant screening, supplementation and on-going clinical management (Holick, 2011). Additional recommendations from the Society for Adolescent Health and Medicine (SAHM) that support indications for vitamin D testing include, immobilization, amenorrhea, and restrictive diet limitations (e.g., vegan/macrobiotic) (Munns 2016; SAHM, 2013). However, based on the current evidence and consensus recommendations, screening for vitamin D deficiency in average-risk, asymptomatic adults and children, is not recommended.

The Cystic Fibrosis Foundation recommends yearly screening for vitamin D status in individuals with cystic fibrosis, preferably at the end of winter when levels are likely to be at their lowest (Tangprincha, 2012). Children with increased risk of vitamin D deficiency, such as those with chronic fat malabsorption and those chronically taking anti-seizure medications, 25-OH-D levels should be repeated at 3-month intervals until normal levels have been achieved, according to the American Academy of Pediatrics (Wagner, 2008).

The USPSTF has rated the current medical evidence insufficient to assess the balance of benefits and harms of screening for vitamin D deficiency in asymptomatic adults. This recommendation is specified to be applicable to “community-dwelling, non-pregnant adults aged 18 years or older who are seen in primary care settings and are not known to have signs or symptoms of vitamin D deficiency or conditions for which vitamin D treatment is recommended” (USPSTF, 2021).

The Endocrine Society published clinical practice guideline recommendations in 2011, which contain the following statement related to screening for vitamin D deficiency in both children and adults, “We recommend screening for vitamin D deficiency in individuals at risk for deficiency. We do not recommend population screening for vitamin D deficiency in individuals who are not at risk.” This recommendation is based on the Endocrine Society’s highest level of evidence and the rating denoted as ‘strong’, meaning the Task Force has confidence that individuals who receive care according to the recommendation “will derive, on average, more good than harm” (Holick, 2011).

The American Society of Clinical Pathology (ASCP, 2020) contributed the following recommendation to Choosing Wisely^®:

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 (e.g., osteoporosis, chronic kidney disease, malabsorption, some infections, obese individuals).

In 2024, the Endocrine Society published clinical practice guidelines on vitamin D for the prevention of disease. Regarding testing for vitamin D deficiency, the convened panel developed the following consensus statement: “Based on the absence of supportive clinical trial evidence, the panel suggests against routine 25(OH)D testing in the absence of established indications.” This recommendation applies to every age group (Demay, 2024).

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. of25-OH-D (i.e., vitamin D testing). According to the Centers for Medicare & Medicaid Services (CMS) Local Coverage Determinations (LCDs) L33996, L37535, L34051, L36692, L39391 and L34658 titled, Vitamin D Assay Testing, “Vitamin D testing may not be used for routine screening.” As stated above, while several nationally recognized clinical practice guidelines address appropriate clinical scenarios for vitamin D testing, none recommend testing for routine screening.

Screening: Examination of a group to separate well persons from those who have an undiagnosed pathologic condition or who are at high risk.

Peer Reviewed Publications:

1. Huang KE, Milliron BJ, Davis SA, Feldman SR. Surge in US outpatient vitamin D deficiency diagnoses: National Ambulatory Medical Care Survey analysis. South Med J. 2014; 107(4):214-217.
2. 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. 2015; 162(2):109-122.
3. Rockwell M, Kraak V, Hulver M, Epling J. Clinical management of low vitamin D: a scoping review of physicians' practices. Nutrients. 2018. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5946278/. Accessed on May 22, 2025.
4. Yayla Ç, Kurek M, Turan I, et al. Association between maternal circulating 25 hydroxyvitamin D concentration and placental volume in the first trimester. J Matern Fetal Neonatal Med. 2017; 30(24):2944-2950.

Government Agency, Medical Society, and Other Authoritative Publications:

1. ACOG Committee on Obstetric Practice. ACOG Committee Opinion No. 495: Vitamin D: screening and supplementation during pregnancy. Obstet Gynecol. 2011 (Reaffirmed 2024); 18(1):197-198.
2. American Society for Clinical Pathology. Choosing Wisely: Fifteen things physicians and patients should question. Updated September 2020. Available at: https://www.ascp.org/content/docs/default-source/get-involved-pdfs/istp_choosingwisely/ascp-35-things-list_2020_final.pdf. Accessed on May 22, 2025. 
3. Centers for Medicare and Medicaid Services (CMS). Local Coverage Determination (LCD): MolDX: Vitamin D Assay Testing.
   • LCD L33996. Available at: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=33996&ver=30&keyword=vitamin%20d&keywordType=starts&areaId=all&docType=NCA,CAL,NCD,MEDCAC,TA,MCD,6,3,5,1,F,P&contractOption=all&sortBy=relevance&bc=1. Accessed on May 22, 2025.
   • LCD L3735. Available at: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=37535&ver=18&keyword=vitamin%20d&keywordType=starts&areaId=all&docType=NCA,CAL,NCD,MEDCAC,TA,MCD,6,3,5,1,F,P&contractOption=all&sortBy=relevance&bc=1. Accessed on May 22, 2025.
   • LCD L34051. Available at: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=34051&ver=42&keyword=vitamin%20d&keywordType=starts&areaId=all&docType=NCA,CAL,NCD,MEDCAC,TA,MCD,6,3,5,1,F,P&contractOption=all&sortBy=relevance&bc=1. Accessed on May 22, 2025.
   • LCD L36692. Available at: LCD - Vitamin D Assay Testing (L36692) (cms.gov) https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=36692&ver=26&keyword=vitamin%20d&keywordType=starts&areaId=all&docType=NCA,CAL,NCD,MEDCAC,TA,MCD,6,3,5,1,F,P&contractOption=all&sortBy=relevance&bc=1. Accessed on May 22, 2025.
   • LCD L34658. Available at: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=34658&ver=34&keyword=vitamin%20d&keywordType=starts&areaId=all&docType=NCA,CAL,NCD,MEDCAC,TA,MCD,6,3,5,1,F,P&contractOption=all&sortBy=relevance&bc=1. Accessed on May 22, 2025.
   • LCD L34658. Available at: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=34658&ver=34&keyword=vitamin%20d&keywordType=starts&areaId=all&docType=NCA,CAL,NCD,MEDCAC,TA,MCD,6,3,5,1,F,P&contractOption=all&sortBy=relevance&bc=1. Accessed on May 22, 2025.
4. Demay MB, Pittas AG, Bikle DD, et al. Vitamin D for the Prevention of Disease: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2024;109(8):1907-1947.
5. Endocrine Society. Choosing Wisely: Five things physicians and patients should question. Reviewed 2017. Available at: https://www.mainlinehealth.org/-/media/files/pdf/basic-content/physicians/mlhpp/choosing-wisely/endocrine-society--choosing-wisely.pdf?la=en. Accessed on May 22, 2025.
6. 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; 96(7):1911-1130.
7. Kahwati LC, LeBlanc E, Weber RP, et al. Screening for vitamin D veficiency in adults: updated evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2021; 325(14):1443-1463.
8. US Preventive Services Task Force (USPSTF), Grossman DC, Curry SJ, et al. Vitamin D, calcium, or combined supplementation for the primary prevention of fractures in community-dwelling adults: US Preventive Services Task Force Recommendation Statement. JAMA. 2018; 319(15):1592-1599.
9. US Preventive Services Task Force, Krist AH, Davidson KW, et al. Screening for vitamin D deficiency in adults: US Preventive Services Task Force Recommendation Statement. JAMA. 2021; 325(14):1436-1442.
10. Misra M, Pacaud D, Petryk A, et al. Vitamin D deficiency in children and its management: review of current knowledge and recommendations. Pediatrics. 2008; 122(2):398-417.
11. Moyer VA; U.S. Preventive Services Task Force*. Vitamin D and calcium supplementation to prevent fractures in adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2013; 158(9):691-696.
12. Munns CF, Shaw N, Kiely M, et al. Global consensus recommendations on prevention and management of nutritional rickets. J Clin Endocrinol Metab. 2016; 101(2):394-415.
13. Society for Adolescent Health and Medicine. Recommended vitamin D intake and management of low vitamin D status in adolescents: a position statement of the Society for Adolescent Health and Medicine. J Adolesc Health. 2013; 52(6):801-803.
14. Tangpricha V, Kelly A, Stephenson A, et al. 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. 2012; 97(4):1082-1093.
15. WHO Guidelines Approved by the Guidelines Review Committee. Guideline: vitamin D supplementation in pregnant women. Geneva: World Health Organization. 2012. Available at: https://www.ncbi.nlm.nih.gov/books/NBK310615/pdf/Bookshelf_NBK310615.pdf. Accessed on May 29, 2025.

1. National Institutes of Health (NIH) Office of Dietary Supplements. Vitamin D: fact sheet for health professionals. Updated on June 2, 2022. Available at: https://ods.od.nih.gov/factsheets/VitaminD-HealthProfessional/. Accessed on May 22, 2025.

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