Summary Of Evidence

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Analysis of Evidence

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History/Background and/or General Information

Vitamin D, a group of fat-soluble prohormones, is an essential Vitamin. There are two major types of Vitamin D (Vitamin D2 and Vitamin D3) which are collectively known as calciferol. They are essential for promoting calcium absorption and maintaining adequate serum calcium and phosphate concentrations to enable mineralization of bone and prevent hypocalcemic conditions. Vitamin D2 (ergocalciferol) is obtained from foods of plant origin and vitamin D3 (cholecalciferol) is obtained from foods of animal origin and ultraviolet light-stimulated conversion of 7-dehydrocholesterol in the skin. Vitamin D is stored in the human body as calcidiol (25-hydroxyvitamin D). Serum concentration of 25(OH) D is the best indicator of Vitamin D status.

Vitamin D deficiencies are the result of dietary inadequacy, impaired absorption and use, increased requirement, or increased excretion. Vitamin D deficiency can occur when usual intake is lower than recommended levels over a period of time, or when exposure to sunlight is limited. Vitamin D deficiency can also result from the inability of the kidneys to convert the Vitamin D to its active form.

There is robust evidence supporting skeletal benefits at a Vitamin D level of 20 ng/mL (50 nmol/L). There is clinical evidence that to achieve non-skeletal benefits of Vitamin D, a level of 30 ng/mL (75 nmol/L) may be required. Currently, the Endocrine Society is endorsing a level of 30 ng/mL (75 nmol/L). Vitamin D deficiency in high risk adults is identified as serum concentration of 25(OH) D <30 ng/mL (75 nmol/L). Vitamin D toxicity can cause symptoms including nausea, vomiting, poor appetite, constipation, weakness, and weight loss as well as elevation in the blood level of calcium which in turn can lead to mental status changes, and heart rhythm abnormalities. Patients receiving Vitamin D supplementation should also be assessed for Vitamin D toxicity and disorders of calcium and phosphorus metabolism.

Covered Indications

The measurement of 25(OH) Vitamin D levels will be considered medically reasonable and necessary for patients with any of the following conditions:

• Chronic kidney disease stage III or greater
• Hypercalcemia
• Hypocalcemia
• Hyperparathyroidism
• Hypoparathyroidism
• Osteomalacia
• Osteoporosis
• Osteopenia
• Rickets
• Vitamin D deficiency to monitor the efficacy of replacement therapy
• Malabsorption states
• Cirrhosis (biliary, hepatic)
• Tuberculosis
• Histoplasmosis
• Coccidioidomycosis
• Berylliosis
• Follicular lymphoma
• Immunodeficiency with predominantly antibody defects
• Sarcoidosis
• Hyperalimentation
• Cystic fibrosis
• Inflammatory Bowel Disease (Crohns, Ulcerative Colitis)
• Radiation enteritis
• Liver cirrhosis
• Psoriasis
• Systemic Lupus Erythematosus
• Myositis
• Obesity
• Bariatric surgery
• Long-term use of medications known to lower vitamin D levels

Limitations

• Only one 25 OH Vitamin D level will be reimbursed in any 24 hour period. 
• Patients with conditions outlined in the indications (acute and high risk conditions associated with Vitamin D deficiency) are candidates for testing. Consider repeat testing in 3-4 months after starting replacement therapy and reassessing if levels < 30 ng/mL (75 nmol/L).
• It’s not reasonable and necessary to perform more than three tests per year.
• Patients with Vitamin D deficiency that have been supplemented to normal levels are limited to one test per year. 

This LCD outlines the indications for Vitamin D, 25-hydroxy. This test is appropriate for assessment of Vitamin D deficiency. Vitamin D, 1,25-dihydroxy is primarily indicated during patient evaluations for hypercalcemia and renal failure. It should not be ordered in addition to Vitamin D, 25-hydroxy for Vitamin D deficiency testing.

Please refer to CMS IOM Publication 100-04, Medicare Claims Processing Manual, Chapter 16, Section 120.1 for additional limitations for Vitamin D assay testing.

As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary.