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| Medical Policy: | L-63-004 |
| Topic: | Vitamin D Assay |
| Section: | Laboratory |
| Effective Date: | October 1, 2016 |
| Issue Date: | October 3, 2016 |
| Last Reviewed: | March 2016 |
Vitamin D metabolites are used to assess serum vitamin D level and metabolism. Specifically, 25-hydroxy vitamin D, referred to as 25(OH)D, and 1,25-dihydroxyvitamin D. The 25 (OH)D metabolite has an estimated half- life of approximately 2 to 3 weeks, and provides a measure of the vitamin D originating from both dietary/supplement sources and from cutaneous(e.g. sun exposure) production. Vitamin D stored in other body tissues are, however, not reflected in the serum 25(OH)D levels. Serum levels of the active vitamin D metabolite, 1,25-dihydroxyvitamin D, may not accurately indicate the individual’s vitamin D status due to its short half-life (15 hours). Since it’s closely regulated by parathyroid hormone and the intake of calcium and phosphate, serum levels of 1,25-dihydroxyvitamin D may appear normal in individuals with vitamin D deficiency. Vitamin D deficiency is defined as a 25(OH)D below 20 ng/ml (50 nmol/liter), and vitamin D insufficiency as a 25(OH)D of 21–29 ng/ml(525–725 nmol/liter). |
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
| Policy Position Coverage is subject to the specific terms of the member’s benefit plan. |
Measurement of cholecalciferol 25-hydroxyvitamin D [25 (OH) D] levels may be considered medically necessary for individuals with: (not all inclusive).
- Clinically documented underlying disease that is specifically associated with vitamin D deficiency, decreased bone density; or
- Individuals considered at high risk for vitamin D deficiency (see list below) and vitamin D supplementation is being taken per the recommended daily amounts; or
- African-American and Hispanic children and adults
- Pregnant and lactating women
- Older adults greater than 65 years with history of falls or non-traumatic fractures
- Obesity; children and adults (BMI greater than or equal to 30)
- Chronic kidney disease; or
- Granuloma forming diseases; or
- Sarcoidosis
- Tuberculosis
- Histoplasmosis
- Coccidiomycosis
- Berylliosis
- Hepatic disease or failure; or
- Hyperparathyroidism; or
- Long term use of anticonvulsants, glucocorticoids, rifampicin, acquired immune deficiency syndrome (aids) medications, antifungals, cholestyramine and other medications known to lower vitamin d levels; or
- Malabsorption states; or
- Crohn’s disease
- Cystic fibrosis
- Inflammatory bowel disease
- Ulcerative colitis
- Bariatric surgery
- Radiation enteritis
- Individuals receiving hyperalimentation; or
- Osteomalacia; or
- Osteoporosis or at risk for osteoporosis; or
- Osteogenesis imperfecta; or
- Rickets; or
- Vitamin D deficiency on replacement therapy; to monitor the efficacy of treatment
25-OH Vitamin D-3 may be tested up to four times per year for Vitamin D deficiencies when the above criteria are met.
Testing and screening for vitamin D deficiency with 25-hydroxyvitamin D [25(OH)D] serum testing is considered not medically necessary for all other indications.
Measurement of 1,25(OH)2D may be considered medically necessary for evaluation of patients with a clinically documented underlying disease or condition associated with increased or decreased 1,25(OH)2D, including:
- Chronic kidney disease; or
- Hypercalcemia with a low parathyroid hormone; or
- Acquired and/or inherited disorders in the metabolism of 25(OH)D and phosphate; or
- Tumor induced osteomalacia (oncogenic osteomalacia); or
- Hereditary phosphate-losing disorders; or
- Vitamin D-dependent rickets type 1 (also known as pseudo-vitamin d deficient rickets); or
- Vitamin D-resistant rickets; or
- Chronic granuloma-forming disorders; or
- Lymphomas
Measurement of 1,25(OH)2D may be tested up to four times per year for Vitamin D deficiencies when the above criteria is met.
With exception in very complex cases (e.g. hypercalcemia with reportedly low endogenous levels of 25-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. In the presence of renal disease, 1,25-dihdroxy vitamin D levels may be needed to adequately assess vitamin D status.
Testing and screening for vitamin D deficiency with 1,25 dihydroxyvitamin D [1,25(OH)2D] serum testing is considered not medically necessary for all other indications.
| Professional Statements and Societal Positions |
Guidelines are in accordance with The Endocrine Society’s Clinical Practice Guidelines: Treatment, and prevention of Vitamin D Deficiency. The Endocrine Society recommends screening for vitamin D deficiency in individuals at risk for deficiency. The society does not recommend population screening for vitamin D deficiency in individuals who are not at risk. It is recommended using the serum circulating 25-hydroxyvitamin D [25(OH)D] level, measured by a reliable assay to evaluate Vitamin D status in patients who are at risk for vitamin D deficiency. The society recommends using the serum 1,25-dihydroxyvitamin D [1,25(OH)2D] assay in monitoring certain conditions, such as acquired and inherited disorders of vitamin D and phosphate metabolism. |
| Place of Service: Outpatient |
A vitamin D assay is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.
| The policy position applies to all commercial lines of business |
| FEP Guidelines |
This medical policy may not apply to FEP. Medical policy is not an authorization, certification, explanation of benefits, or a contract. Benefits are determined by the Federal Employee Program. |
| Denial Statements |
Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
Quantity level limits or quantity of supplies that exceed the frequency guidelines listed on the policy will be denied as non-covered. A network provider cannot bill the member for the non-covered service.
| Links |
- Link to Provider Resource Center for the Medical Policy Update
09/2015, Clinical Criteria Established for Vitamin D Assay Testing and Applies to Professional and Facility claims
 |
Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
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U.S. Department of Health and Human Services
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Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)
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