Medical Policy: 02.04.34
Original Effective Date: November 2011
Reviewed: February 2017
Revised: February 2017
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.
The Endocrine Society has released guidelines for certain at-risk populations for vitamin D deficiency: 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.
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.
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.
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.
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.
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.
Testing of Vitamin D levels may be considered medically necessary to monitor therapy when Vitamin D deficiency is diagnosed. Routine testing and general population screening is considered not medically necessary.
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.
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.
There are rarely indications for ordering both 25-hydroxy vitamin D and1,25-dihydroxy vitamin D on the same specimen at the same time. The 1,25-dihydroxyvitamin D [1,25(OH)2D] assay \should only be used in monitoring certain conditions, such as acquired and inherited disorders of vitamin D and phosphate metabolism.
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.
Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc. They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.
*CPT® is a registered trademark of the American Medical Association.