Medical Policy: 02.04.34
Original Effective Date: November 2011
Reviewed: January 2021
Revised: January 2021
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
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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. Commercial assays measure total 25(OH)D, but some laboratories report 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3 values separately. It is the total 25(OH)D concentration that is clinically important.
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. Some patients with vitamin D deficiency have coexisting primary hyperparathyroidism that is not recognized until vitamin D is repleted. Hypercalcemia may not be evident initially if the vitamin D deficiency is severe. Calcium concentrations are normal or at the upper-end of the normal range and PTH concentrations are elevated. Vitamin D replacement in these individuals should be provided cautiously as hypercalcemia may develop. In this scenario: 1,25-dihydroxy vitamin D levels (cpt code 82652) may be needed.
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 central question today is not whether the body needs vitamin D, it absolutely does, but whether the average person should be taking a supplement or be tested for deficiency. There is widespread public belief that it’s a good idea. The scientific evidence on the value of supplementation and testing in the asymptomatic, as well as numerous diseases and conditions, is minimal overall. Signs and symptoms of vitamin D deficiency are largely manifested by changes in bone health and biochemical markers associated with bone production and resorption. In most cases, onl;y a clinical diagnosis of an abnormality in bone health (eg, rickets, osteomalacia, osteoporosis) should lead to a decision to test vitamin D levels.
No RCTs were found that evaluated clinical outcomes or harms in patients tested for vitamin D deficiency vs not tested for vitamin D deficiency. Evidence from multiple systematic reviews and meta-analyses does not support a benefit on overall mortality for the general, noninstitutionalized population.
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.
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.
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 Consensus-based Care Recommendations for Adults with Myotonic Dystrophy Type 2 (2019) lists Vitamin D under Severe Symptoms, Endocrine and metabolic, under Recommendations to test for. The Consensus-based Care Recommendations for Children with Myotonic Dystrophy Type 1 (2019) does not address Vitamin D testing.
The 2020 American Association of Clinical Endocrinologists/ American College of Endocrinology, The Obesity Society, American Society for Metabolic & Bariatric Surgery, Obesity Medicine Association, and American Society of Anesthesiologists Clinical Practice Guidelines for the Perioperative nutrition, metabolic, and nonsurgical support of patients undergoing Bariatric procedures recommends: • Baseline and annual postoperative evaluation for vitamin D deficiency is recommended after Roux-en-Y gastric bypass, sleeve gastrectomy, or laparoscopic biliopancreatic diversion without or with duodenal switch (Recommendation 53)
Information updated in 2018: 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).
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 USPSTF guidelines do not recommend vitamin D testing for screening purposes. In a 2015 update of their recommendations regarding screening for vitamin D deficiency in adults, the USPSTF concluded, “that the current evidence is insufficient to assess the balance of benefits and harms of screening for vitamin D deficiency in asymptomatic adults.” (I statement) In the 2020 draft of the updated evidence review, the final recommendation upholds the same conclusion; however, the final version is not yet published.
In 2018, the United States (U.S.) Preventative Service Task Force (USPSTF) concluded that the current evidence is insufficient to assess the balance of the benefits and harms of vitamin D and calcium supplementation, alone or combined, for the primary prevention of factures in men and premenopausal women. (I statement) The USPSTF also concluded that the current evidence is insufficient to assess the balance of the benefits and harms of daily supplementation with doses greater than 400 IU of vitamin D and greater than 1000 mg of calcium for the primary prevention of fractures in community-dwelling, postmenopausal women. (I statement) Additionally, the USPSTF recommended against daily supplementation with 400 IU or less of vitamin D and 1000 mg or less of calcium for the primary prevention of fractures in community-dwelling, postmenopausal women. (D recommendation)
Community-dwelling is defined as not living in a nursing home or other institutional care setting. The USPSTF recommendations do not apply to those with a history of osteoporotic fractures, increased risk for falls, or diagnosis of osteoporosis or vitamin D deficiency.
I statements are defined as follows: The USPSTF concludes that the current evidence is insufficient to assess the balance and benefits and harms of the service. Evidence is lacking, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined.
D recommendations are defined as follows: The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits. The USPSTF guidelines for preventive care are an authoritative standard and are recognized as such by the Affordable Care Act.
The following recommendation was made about 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 25-OH-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.
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.
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.
The Amercan Academy of Family Physicians concluded that the current evidence was insufficient to assess the balance of benefits and harms of screening for vitamin D deficiency (AAFP, 2018).
The position statement: on “Clinical Management of Vitamin D Deficiency in Adults” (Cesareo et al, 2018) stated that “Healthy people should not be screened by the 25-hydroxy-vitamin D assay; and no routine monitoring 25-hydroxy-vitamin D is suggested during vitamin D treatment due to its large therapeutic index”.
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.
1,25(OH)2D [1,25-dihydroxyvitamin D] testing is not recommended to evaluate vitamin D status. However, the guideline does recommend monitoring calcitriol levels in certain conditions. The testing is considered medically necessary for the following conditions:
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.
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 evidence includes no randomized controlled trials (RCTs) of clinical utility (ie, evidence that patient care including testing vitamin D levels vs care without testing vitamin D levels improves outcomes). The role of vitamin D has also 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. Although vitamin D toxicity and adverse events appear to be rare, little data on risks have been reported. The evidence is insufficient to determine the effects of testing on health outcomes.
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