MEDICAL POLICY Vitamin D Testing

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1 POLICY: PG0433 ORIGINAL EFFECTIVE: 05/24/18 LAST REVIEW: MEDICAL POLICY Vitamin D Testing GUIDELINES This policy does not certify benefits or authorization of benefits, which is designated by each individual policyholder contract. Paramount applies coding edits to all medical claims through coding logic software to evaluate the accuracy and adherence to accepted national standards. This guideline is solely for explaining correct procedure reporting and does not imply coverage and reimbursement. DESCRIPTION Vitamin D, also known as calciferol, is a fat-soluble vitamin that has a variety of physiologic effects, most prominently in calcium homeostasis and bone metabolism. In addition to the role it plays in bone metabolism, other physiologic effects include inhibition of smooth muscle proliferation, regulation of the renin-angiotensin system, decrease in coagulation, and decrease in inflammatory markers. Vitamin D has two forms: 1. Vitamin D2 (ergocalciferol) 2. Vitamin D3 (cholecalciferol) Vitamin D testing to determine serum levels may be performed for two purposes: 1. To assess serum levels in patients with signs and/or symptoms of toxicity or deficiency or with conditions strongly associated with vitamin D deficiency; or 2. To screen for potential deficiencies in: Healthy individuals without signs or symptoms of an illness/disease (e.g., vitamin D screening as a part of routine health exams); or Individuals with general symptoms which are not specific to or suggestive of vitamin D deficiency. Vitamin D intake (food and supplements) can be expressed in either International Units (IU) or micrograms (μg) (1 μg = 40 IU vitamin D). Vitamin D is available from a limited number of dietary sources (fish liver oils, fatty fish, egg yolks, and fortified foods), supplementation, and from skin synthesis upon exposure to ultraviolet radiation from the sun. There are 2 forms of activated vitamin D for which testing is performed: hydroxyvitamin D [25(OH)D], calcidiol that is the most abundant circulating form of vitamin D and is the most common measure of serum levels. 2. 1,25-dihydroxyvitamin D [1,25(OH)2D], calcitriol that is the most metabolically active form, but generally not considered to be a reliable measurement of vitamin D as it has a very short half-life. Production in the kidney is closely regulated by a number of different factors, and a significant decrease is observed only when deficiency is severe. However, there may be a role for 1,25-dihydroxyvitamin D serum testing in the evaluation and treatment of a limited number of medical indications. For these conditions, 1,25(OH)2D serum testing is not a measure of vitamin D deficiency related to inadequate sunlight and/or nutritional exposure. Rather, the test is a measure of abnormal vitamin D metabolism and may be an indicator of disease. There is research showing that vitamin D plays an essential role in promoting bone growth and maintenance, however, there is considerable uncertainty with respect to the clinical utility of testing, both in healthy, asymptomatic populations and for conditions not directly associated with bone health or deficiencies in vitamin D metabolism. Several studies consistently report a lack of evidence demonstrating how vitamin D testing alters treatment decisions or improves health outcomes. In addition, these reports note a lack of information on the levels of vitamin D that define a deficiency. There are no evidence-based clinical practice guidelines that recommend routine vitamin D testing or screening. Additionally, the United States Preventive Services Task Force guidelines, a nationally recognized standard, do not recommend routine screening as a preventive health measure. Therefore, vitamin D testing is considered not medically necessary in the absence of conditions specifically associated with underlying diseases or conditions associated with vitamin D deficiency, decreased bone density, or defects in vitamin D metabolism. POLICY Testing of vitamin D levels does not require prior authorization when determined to be medically necessary

2 because the medical criteria and guidelines shown below are met. Sensieva Droplet 25OH Vitamin D2/D3 Microvolume LC/MS Assay (0038U) is non-covered. HMO, PPO, Individual Marketplace, Elite, Advantage 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. Testing vitamin D levels in individuals with no known signs or symptoms of vitamin D deficiency or intoxication nor conditions for which vitamin D treatment is recommended is considered not medically necessary. Vitamin D, 25-hydroxy testing (82306) 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. The ICD-10 diagnosis codes that are appropriate for vitamin D, 25-hydroxy testing (82306) are listed below in the CODING/BILLING INFORMATION section. The testing is considered medically necessary for the following conditions: Osteoporosis Osteomalacia Osteopenia Malabsorption Syndromes (Cystic Fibrosis, Celiac Disease, Bariatric Surgery) Chronic Kidney Disease Stage III or greater Cirrhosis Rickets Osteogenesis Imperfecta Parathyroid disorders Hypocalcemia Hypercalcemia Hypercalciura Obstructive jaundice Osteosclerosis/petrosis Granuloma forming Disorders (Sarcoidosis, Tuberculosis, Histoplasmosis, Coccidiomycosis, Berylliosis) Chronic use of anticonvulsant medications Vitamin D, 1,25-dihydroxy testing (82652) is not recommended to evaluate vitamin D status. It should not be ordered in addition to vitamin D, 25-hydroxy for vitamin D deficiency testing. However, the guideline does recommend monitoring calcitriol levels in certain conditions. The ICD-10 diagnosis codes that are appropriate for vitamin D, 1,25-dihydroxy testing (82652) are listed below in the CODING/BILLING INFORMATION section. The testing is considered medically necessary for the following conditions: Cat-scratch disease Hyperparathyroidism Hypoparathyroidism Pseudohypoparathyroidism Hypercalcemia of malignancy Granulomatous diseases Renal failure Follicular Lymphoma Psoriasis Systemic connective tissue disorder Testing and screening for vitamin D deficiency with vitamin D, 25-hydroxy testing (82306) and vitamin D, 1,25- dihydroxy testing (82652) is considered not medically necessary for all other indications. CODING/BILLING INFORMATION The appearance of a code in this section does not necessarily indicate coverage. Codes that are covered may have selection criteria that must be met. Payment for supplies may be included in payment for other services rendered.

3 CPT CODES Vitamin D; 25 hydroxy, includes fraction(s), if performed Vitamin D; 1, 25 dihydroxy, includes fraction(s), if performed 0038U Vitamin D, 25 hydroxy D2 and D3, by LC-MS/MS, serum microsample, quantitative ICD-10-CM CODES CONSIDERED MEDICALLY NECESSARY FOR CODE A15.0-A19.9 Tuberculosis C22.0-C22.9 Malignant neoplasm of liver and intrahepatic bile ducts C23 Malignant neoplasm of gallbladder C24.0-C24.9 Malignant neoplasm of other and unspecified parts of biliary tract C25.0-C25.9 Malignant neoplasm of pancreas C26.0-C26.9 Malignant neoplasm of other and ill-defined digestive organs D13.0-D13.9 Benign neoplasm of other and ill-defined parts of digestive system D86.0-D86.89 Sarcoidosis E20.0 Idiopathic hypoparathyroidism E20.8 Other hypoparathyroidism E20.9 Hypoparathyroidism, unspecified E21.0-E21.5 Hyperparathyroidism and other disorders of parathyroid gland E55.0-E55.9 Vitamin D deficiency E64.3 Sequelae of rickets E67.2 Megavitamin-B6 syndrome E67.3 Hypervitaminosis D E67.8 Other specified hyperalimentation E68 Sequelae of hyperalimentation E83.30-E83.39 Disorders of phosphorus metabolism and phosphatases E83.50-E83.59 Disorders of calcium metabolism E84.0-E84.9 Cystic fibrosis E89.2 Postprocedural hypoparathyroidism G73.7 Myopathy in diseases classified elsewhere K50.00-K Crohn s disease [regional enteritis] K51.00-K Ulcerative colitis K70.2 Alcoholic fibrosis and sclerosis of liver K70.30-K70.31 Alcoholic cirrhosis of liver K74.0-K74.69 Fibrosis and cirrhosis of liver K75.81 Nonalcoholic steatohepatitis (NASH) K76.0 Fatty (change of) liver, not elsewhere classified K76.89 Other specified diseases of liver K80.01 Calculus of gallbladder with acute cholecystitis with obstruction K80.11 Calculus of gallbladder with chronic cholecystitis with obstruction K80.13 Calculus of gallbladder with acute and chronic cholecystitis with obstruction K80.19 Calculus of gallbladder with other cholecystitis with obstruction K80.21 Calculus of gallbladder without cholecystitis with obstruction K80.31 Calculus of bile duct with cholangitis, unspecified, with obstruction K80.33 Calculus of bile duct with acute cholangitis with obstruction K80.35 Calculus of bile duct with chronic cholangitis with obstruction K80.37 Calculus of bile duct with acute and chronic cholangitis with obstruction K80.41 Calculus of bile duct with cholecystitis, unspecified, with obstruction K80.43 Calculus of bile duct with acute cholecystitis with obstruction K80.45 Calculus of bile duct with chronic cholecystitis with obstruction K80.47 Calculus of bile duct with acute and chronic cholecystitis with obstruction K80.51 Calculus of bile duct without cholangitis or cholecystitis with obstruction K80.61 Calculus of gallbladder and bile duct with cholecystitis, unspecified, with obstruction K80.63 Calculus of gallbladder and bile duct with acute cholecystitis with obstruction K80.65 Calculus of gallbladder and bile duct with chronic cholecystitis with obstruction K80.67 Calculus of gallbladder and bile duct with acute and chronic cholecystitis with obstruction K80.71 Calculus of gallbladder and bile duct without cholecystitis with obstruction K80.81 Other cholelithiasis with obstruction K82.0 Obstruction of gallbladder K82.8 Other specified diseases of gallbladder K82.9 Disease of gallbladder, unspecified K83.0-K83.9 Other diseases of biliary tract K85.10-K85.12 Biliary acute pancreatitis

4 K86.2 Cyst of pancreas K86.3 Pseudocyst of pancreas K86.81-K86.89 Other specified diseases of pancreas K86.9 Disease of pancreas, unspecified K87 Disorders of gallbladder, biliary tract and pancreas in diseases classified elsewhere K90.0-K90.49 Intestinal malabsorption K90.89 Other intestinal malabsorption K90.9 Intestinal malabsorption, unspecified K91.2 Postsurgical malabsorption, not elsewhere classified L40.0-L40.4 Psoriasis L40.8 Other psoriasis L40.9 Psoriasis, unspecified L90.0 Lichen sclerosus et atrophicus L94.0 Localized scleroderma [morphea] L94.1 Linear scleroderma L94.3 Sclerodactyly M32.0-M32.8 Systemic lupus erythematosus (SLE) M33.01-M33.09 Juvenile dermatomyositis M33.11-M33.19 Other dermatomyositis M33.91-M33.99 Dermatopolymyositis M36.0 Dermato(poly)myositis in neoplastic disease M Other myositis, right shoulder M Other myositis, left shoulder M Other myositis, right upper arm M Other myositis, left upper arm M Other myositis, right forearm M Other myositis, left forearm M Other myositis, right hand M Other myositis, left hand M Other myositis, right thigh M Other myositis, left thigh M Other myositis, right lower leg M Other myositis, left lower leg M Other myositis, right ankle and foot M Other myositis, left ankle and foot M60.88 Other myositis, other site M60.89 Other myositis, multiple sites M79.1 Myalgia M79.7 Fibromyalgia M81.0-M81.8 Osteoporosis without current pathological fracture M83.0-M83.9 Adult osteomalacia M85.80 Other specified disorders of bone density and structure, unspecified site M Other specified disorders of bone density and structure, right shoulder M Other specified disorders of bone density and structure, left shoulder M Other specified disorders of bone density and structure, right upper arm M Other specified disorders of bone density and structure, left upper arm M Other specified disorders of bone density and structure, right forearm M Other specified disorders of bone density and structure, left forearm M Other specified disorders of bone density and structure, right hand M Other specified disorders of bone density and structure, left hand M Other specified disorders of bone density and structure, right thigh M Other specified disorders of bone density and structure, left thigh M Other specified disorders of bone density and structure, right lower leg M Other specified disorders of bone density and structure, left lower leg M Other specified disorders of bone density and structure, right ankle and foot M Other specified disorders of bone density and structure, left ankle and foot M85.88 Other specified disorders of bone density and structure, other site M85.89 Other specified disorders of bone density and structure, multiple sites M85.9 Disorder of bone density and structure, unspecified M88.0 Osteitis deformans of skull M88.1 Osteitis deformans of vertebrae

5 M Osteitis deformans of right shoulder M Osteitis deformans of left shoulder M Osteitis deformans of right upper arm M Osteitis deformans of left upper arm M Osteitis deformans of right forearm M Osteitis deformans of left forearm M Osteitis deformans of right hand M Osteitis deformans of left hand M Osteitis deformans of right thigh M Osteitis deformans of left thigh M Osteitis deformans of right lower leg M Osteitis deformans of left lower leg M Osteitis deformans of right ankle and foot M Osteitis deformans of left ankle and foot M88.88 Osteitis deformans of other bones M88.89 Osteitis deformans of multiple sites M88.9 Osteitis deformans of unspecified bone M89.9 Disorder of bone, unspecified M94.9 Disorder of cartilage, unspecified N18.2-N18.9 Chronic kidney disease (CKD) N25.81 Secondary hyperparathyroidism of renal origin O Bariatric surgery status complicating pregnancy, childbirth and the puerperium O Q78.0 Osteogenesis imperfecta Q78.2 Osteopetrosis T30.0-T30.4 Burn and corrosion, body region unspecified Z32.00-Z32.3 Encounter for pregnancy test and childbirth and childcare instruction Z33.1-Z33.3 Pregnant state Z34.00-Z34.93 Encounter for supervision of normal pregnancy Z36.0-Z36.9 Encounter for antenatal screening of mother Z3A.00-Z3A.49 Weeks of gestation Z37.0-Z37.9 Outcome of delivery Z38.00-Z38.8 Liveborn infants according to place of birth and type of delivery Z39.0-Z39.2 Encounter for maternal postpartum care and examination Z79.3 Long term (current) use of hormonal contraceptives Z79.51-Z79.52 Long term (current) use of steroids Z Long term (current) use of opiate analgesic Z Other long term (current) drug therapy Z98.84 Bariatric surgery status ICD-10-CM CODES CONSIDERED MEDICALLY NECESSARY FOR CODE A15.0-A19.9 Tuberculosis C83.80-C83.89 Other non-follicular lymphoma C84.00-C84.09 Mycosis fungoides C84.10-C84.19 Sezary disease C88.4 Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue [MALTlymphoma] D86.0-D86.89 Sarcoidosis E20.0 Idiopathic hypoparathyroidism E20.8 Other hypoparathyroidism E20.9 Hypoparathyroidism, unspecified E21.0-E21.5 Hyperparathyroidism and other disorders of parathyroid gland E55.0-E55.9 Vitamin D deficiency E64.3 Sequelae of rickets E67.2 Megavitamin-B6 syndrome E67.8 Other specified hyperalimentation E68 Sequelae of hyperalimentation E83.30-E83.39 Disorders of phosphorus metabolism and phosphatases E83.50-E83.59 Disorders of calcium metabolism E89.2 Postprocedural hypoparathyroidism

6 M83.0-M83.9 Adult osteomalacia N18.2-N18.9 Chronic kidney disease (CKD) N25.81 Secondary hyperparathyroidism of renal origin Q78.0 Osteogenesis imperfecta Q78.2 Osteopetrosis Z32.00-Z32.3 Encounter for pregnancy test and childbirth and childcare instruction Z33.1-Z33.3 Pregnant state Z34.00-Z34.93 Encounter for supervision of normal pregnancy Z36.0-Z36.9 Encounter for antenatal screening of mother Z3A.00-Z3A.49 Weeks of gestation Z37.0-Z37.9 Outcome of delivery Z38.00-Z38.8 Liveborn infants according to place of birth and type of delivery Z39.0-Z39.2 Encounter for maternal postpartum care and examination TAWG REVIEW DATES: 05/24/2018 REVISION HISTORY EXPLANATION 05/24/18: 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. The ICD-10 diagnosis codes that are appropriate for vitamin D, 25-hydroxy testing (82306) and vitamin D, 1,25-dihydroxy testing (82652) are listed in this policy. Sensieva Droplet 25OH Vitamin D2/D3 Microvolume LC/MS Assay (0038U) is non-covered. Policy created to reflect most current clinical evidence per The Technology Assessment Working Group (TAWG). REFERENCES/RESOURCES Centers for Medicare and Medicaid Services, CMS Manual System and other CMS publications and services Ohio Department of Medicaid American Medical Association, Current Procedural Terminology (CPT ) and associated publications and services Centers for Medicare and Medicaid Services, Healthcare Common Procedure Coding System, HCPCS Release and Code Sets Industry Standard Review Hayes, Inc.

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