Local Coverage Determination (LCD)

Vitamin D Assay Testing

L33996

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Contractor Information

LCD Information

Document Information

LCD ID
L33996
LCD Title
Vitamin D Assay Testing
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL33996
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 08/04/2022
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
07/23/2020
Notice Period End Date
09/06/2020
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Issue

Issue Description

This LCD outlines limited coverage for this service with specific details under Coverage Indications, Limitations, and/or Medical Necessity.

CMS National Coverage Policy

Language quoted from Centers for Medicare and Medicaid Services (CMS). National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the Local Coverage Determination (LCD) Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See Section 1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:

Title XVIII of the Social Security Act (SSA):

Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Abstract:

Vitamin D is a hormone, synthesized by the skin and metabolized by the kidney to an active hormone, calcitriol. An excess of vitamin D may lead to hypercalcemia. Vitamin D deficiency may lead to a variety of disorders. This LCD identifies the indications and limitations of Medicare coverage and reimbursement for these services.

Vitamin D is called a "vitamin" because of its exogenous source, predominately from oily fish in the form of vitamin D2 and vitamin D3. It is really a hormone, synthesized by the skin and metabolized by the kidney to an active hormone, calcitriol, which then acts throughout the body. In the skin, 7-dehydrocholesterol is converted to vitamin D3 in response to sunlight, a process that is inhibited by sunscreen with a skin protection factor (SPF) of 8 or greater. Once in the blood, vitamin D2 and D3 from diet or skin bind with vitamin D binding protein and are carried to the liver where they are hydroxylated to yield calcidiol. Calcidiol then is converted in the kidney to calcitriol by the action of 1a-hydroxylase (CYP27B1). The CYP27B1 in the kidney is regulated by nearly every hormone involved in calcium homeostasis, and its activity is stimulated by PTH, estrogen, calcitonin, prolactin, growth hormone, low calcium levels, and low phosphorus levels. Its activity is inhibited by calcitriol, thus providing the feedback loop that regulates calcitriol synthesis.

An excess of vitamin D is unusual, but may lead to hypercalcemia. Vitamin D deficiency may lead to a variety of disorders, the most infamous of which is rickets. Evaluating patients’ vitamin D levels is accomplished by measuring the level of 25-hydroxyvitamin D. Measurement of other metabolites is generally not medically necessary.
 
Indications:

Measurement of vitamin D levels is indicated for patients with:

  • chronic kidney disease stage III or greater;
  • osteoporosis;
  • osteomalacia;
  • osteopenia;
  • hypocalcemia;
  • hypercalcemia;
  • hypercalciura;
  • hypoparathyroidism;
  • hyperparathyroidism;
  • malabsorption states;
  • cirrhosis;
  • hypervitaminosis D;
  • obstructive jaundice;
  • osteosclerosis/petrosis;
  • rickets;
  • low exposure to sunlight; and
  • vitamin D deficiency to monitor the efficacy of replacement therapy
  • Obesity

Limitations:
For Medicare beneficiaries, screening tests are governed by statute. Vitamin D testing may not be used for routine screening.

Once a beneficiary has been shown to be vitamin D deficient, further testing is medically necessary only to ensure adequate replacement has been accomplished. Thereafter, annual testing may be appropriate depending upon the indication and other mitigating factors.

Summary of Evidence

Obesity

Obesity has been linked to vitamin D deficiency thought to be due the sequestration of vitamin D in body fat leading to reduced availability of vitamin D and lower dietary intake of vitamin D containing supplements [1, 2]. Early studies found lower serum Vitamin D levels in non-operative morbidly obese patients, with 62% having deficiencies in serum 25-hydroxyvitamin D (25-OHD) levels [3]. A prospective cohort study comparing obese to non-obese subjects found a serum 25-OHD and 1,25-dihydroxy vitamin D was negatively correlated with body mass index (BMI) in Caucasian and African-American adults (p<0.0001 for both groups) [4]. A large Canadian cohort with 5,569 individuals reported that a BMI >30 (obese) was strongly associated with lower levels of serum 25-OHD (<75nmol/L) in both males and females. A multivariate regression analysis that included dietary intake of vitamin D, sunlight exposure, and supplementation showed the impact of BMI was an independent variable (-11.12 (-14.04;-8.21) females and -8.17 (-13.49; -2.85) males [5]. National Health and Nutrition Examination Survey (NHANES) data reported lower concentrations of 25-OHD levels among obese white women compared to leaner counterparts [2]. Obese adults also have been found to have difficulty raising their vitamin D levels by sunlight, ultraviolet light exposure, or supplementation as compared to nonobese adults [6, 7].

Analysis of Evidence (Rationale for Determination)

Obesity

The American Association of Clinical Endocrinologists, The Obesity Society and American Society for Metabolic, and Bariatric Surgery Guidelines recommend vitamin D supplements titrated to therapeutic 25-hydroxyvitamin D levels >30ng/ml after bariatric surgery (Grade A recommendation)[8]. Up to Date includes obese patients at a high-risk for vitamin D insufficiency[9]. Obese individual are considered high-risk for vitamin D deficiency. The relationship between obesity and vitamin D deficiency has been clearly reported and supported by societal guidance. Obesity is a reasonably and medically necessary indication for Vitamin D Assay measurement.

General Information

Associated Information

N/A

Sources of Information

This bibliography presents those sources that were obtained during the development of this policy. CGS Administrators is not responsible for the continuing viability of Web site addresses listed below.

Adams J, Kantorovich V, Wu C, Javanbakt M, Hollis B. Resolution of vitamin D insufficiency in osteopenic patients results in rapid recovery of bone mineral density. The Journal of Clinical Endocrinology and Metabolism. 1999;84:8:2729-2730.

Autier P, Gandini S. Vitamin D supplementation and total mortality. Arch Intern Med. 2007;167:16:1730-1737.

Bischoff-Ferrari HA, Dawson-Hughs B, Willett W, et al. Effect of vitamin D on falls a meta-analysis. JAMA. 2004;291:16:1999-2006. www.jama.com. Accessed 03/04/2009.

Bischoff-Ferrari HA, Dietrich T, Orav EJ, Dawson-Hughes B. Positive association between 25-Hydroxy vitamin D levels and bone mineral density: a population-based study of younger and older adults. The American Journal of Medicine. 2004;116:634-639.

Bischoff-Ferrari HA, Willett W, Wong J, Giovannucci E, Dietrich T, Dawson-Hughes B. Fracture prevention with vitamin D supplementation, a meta-analysis of randomized controlled trials. JAMA. 2005;293:18:2257-2264. www.jama.com. Accessed 03/04/2009.

Bodnar LM, Simhan HN, Powers RW, Frank MP, Cooperstein E, Roberts JM. High prevalence of vitamin D insufficiency in black and white pregnant women residing in the northern United States and their neonates. J Nutr. 2007;137:447-452. http://jn.nutrition.org. Accessed 02/10/2009.

Brenner: Brenner and Rector's The Kidney, 8th ed. Saunders, An imprint of Elsevier. Copyright © 2007.

Brophy Marcus M. Vitamin D tests soar as deficiency, diseases linked. USATODAY.com. Accessed 03/12/2009.

Cannell JJ. Autism and Vitamin D. Med Hypothese. 2008;70:4:750-759. http://www.ncbi.nlm.nih.gov/pubmed/17920208. Accessed 02/10/2009.

Cannell JJ, Hollis BW, Zasloff M, Heaney RP. Diagnosis and treatment of vitamin D deficiency. Expert Opin Pharmacother. 2008;9:1-12.

Chapuy M, Arlot M, Duboeuf F, et al. vitamin D3 and calcium to prevent hip fractures in elderly women. The New England Journal of Medicine.1992;327:23:1637-1641.

Chronic Kidney Disease 2006: A Guide to Select NKF-KDOQI Guidelines and Recommendations.

Clinical practice guidelines for bone metabolism and disease in chronic kidney disease. American Journal of Kidney Diseases. October 2004.

Cranney A, Horsley T, O'Donnell, et al. Effective and safetly of vitamin D in relation to bone health. AHRQ Publication No. 07-E013. August 2007.

Dawson-Hughes B, Harris S, Krall E, Dallal G. Effect of calcium and vitamin D supplementation on bone density in men and women 65 years of age or older. The New England Journal of Medicine. 1997;337:10:670-676.

Diamond T, Eisman J, Mason R, et al. Vitamin D and adult bone health in Australia and New Zealand: a position statement. MJA. 2005;182:6.

Disorders involving calcium, phosphorus, and magnesium. Primary Care: Clinics in Office Practice. 2008;35:2. W. B. Saunders Company; Copyright© 2008.

Dusso AS, Brown AJ, Slatopolsky E. Vitamin D. Am J Physiol Renal Physiol. 2005;289:F8-F28.

Gaugris S, Heaney RP, Boonen S, et al. Vitamin D inadequacy among post-menopausal women: a systematic review. Q J Med. 2005;98:667-676.

Giovannucci E. Can vitamin D reduce total mortality? Arch Intern Med. 2007;167:16:1709-1710.

Goltzman D and Cole DEC. Hypoparathyroidism. In primer on the metabolic bone diseases and disorders of bone metabolism. American society of bone and mineral research, 2006;6:216.

Hathcock J, Shao A, Vieth R, Heaney R. Risk assessment for vitamin D. Am J Clin Cutr. 2007;85:6-18.

Heaney R. Nutrition and chronic disease. Mayo Clin Proc. 2006;81:3:297-299.

Holick MF. Resurrection of vitamin D deficiency and rickets. J Clin Invest. 2006;116:2062-72.

Holick, M. High prevalence of vitamin D inadequacy and implications for health. Mayo Clin Proc. 2006;81:3:353-373.

Holick M. Vitamin D Deficiency. N Engl J Med. 2007;357:266-81.

Hollis B. Vitamin D requirement during pregnancy and lactation. Journal of Bone and Mineral Research. 2007;V39-V44.

Hollis B, Wagner, C. Vitamin D requirements during lactation: high-dose maternal supplementation as therapy to prevent hypovitaminosis D for both the mother and the nursing infant. 2004;80:1752s-1758s. www.ajcn.org. Accessed 02/10/09.

Jackson R, LaCroix A, Gass M, et al. Calcium plus vitamin D supplementation and the risk of fracture. N Engl J Med. 2006;354:7. www.nejm.org. Accessed 02/10/2009.

Kronenberg: Williams Textbook of Endocrinology, 11th ed. Vitamin D related disorders. Saunders, An Imprint of Elsevier; Copyright © 2008. www.mdconsult.com. Accessed 10/02/2008.

Lal Y, Nair P, Lovrien F and Freeman JW. Osteomalacia presenting as pain syndromes of uncertain etiology. S D Med. 2009;62:5:197,199, 201.

Lappe J, Travers-Gustafson D, Davies K, Recker R, Heaney R. Am J Clin Nutr. 2007;85:1586-91.

Lata PF, Elliott ME. Patient assessment in the diagnosis, prevention, and treatment of osteoporosis. Nutrition in Clinical Practice. 2007;22:3:261-275.

LeBoff M, Kohlmeier L, Hurwitz S, Franklin J, Wright J, Glowacki J. Occult vitamin D deficiency in postmenopausal US women with acute hip fracture. JAMA. 1999;281:16:1505-1511.

Leventis P, Patel S. Clinical aspects of vitamin D in the management of rheumatoid arthritis. Rheumatology. 2008;47:11:1617-1621.

Liu PT, Stenger S, Li H, et al. Toll-like receptor triggering of a vitamin D-mediated human antimicrobial response. Science. 2006;311:1770-1773.

McPherson & Pincus: Henry's Clinical Diagnosis and Management by Laboratory Methods. 21st ed. W. B. Saunders Company; Copyright © 2006.

Metabolic bone disease in gastrointestinal illness. Gastroenterology Clinics. 2007;36:1. W. B. Saunders Company; Copyright © 2007.

Moe S. Disorders involving Calcium, Phosphorus and Magnesium. Prim Care Clin Office Pract. 2008;35;215-237.

Mouyis M, Ostor A, Crisp A, et al. Hypovitaminosis D among rheumatology outpatients I clinical practice. Rheumatology 2008;47:1349-1351.

Prince R, Austin N, Devine A, Dick I, Bruce D, Zhu K. Effects of ergocalciferol added to Calcium on the risk of falls in elderly high-risk women. Arch Intern Med. 2008;168:1:103-108.

Shoback D. Update in osteoporosis and metabolic bone disorders. Journal of Clinical Endocrinology & Metabolism. 2007;92:3:747-753. jcem.endojournals.org. Accessed 02/10/2009.

Silverberg SJ and Bilezikian JP. Primary hyperparathyroidism. In:primer on metabolic bone diseases and disorders of mineral metabolism. 7th ed. 2008;7;302-306.

Silverberg SJ, Shane E, Dempster DW, Bilezikian JP. The effects of vitamin D insufficiency in patients with primary hyperparathyroidism. Am J Med. 1999;107:6:561-561.

Slovik D, Adams J, Neer R, Holick M, Potts J. Deficient production of 1,25-Dihydroxyvitamin D in elderly osteoporotic patients. The New England Journal of Medicine. 1981;305:7:372-374.

Vieth R, Bischoff-Ferrari H, Boucher B, et al. The urgent need to recommend an intake of vitamin D that is effective. Am J of Clin Nutr. 2007;85:649-650.

Wagner CL, Greer FR. Prevention of rickets and vitamin D deficiency in infants, children and adolescents. Pediatrics 2008;122:1142-1152. www.pediatrics.org. Assessed February 10, 2009.

Wang T, Pencina M, Booth S, et al. Vitamin D deficiency and risk of cardiovascular disease. Circulation. 2008;117:503-511. circ.ahajournals.org. Accessed 03/02/2009.

Wu F, Staykova T, Horne A, et al. Efficacy of an oral, 10-day course of high-dose calciferol in correcting vitamin D deficiency. The New Zealand Medical Journal. 2003;116:1179:1-5.

Zerwekh J. Assessment of vitamin D in population-based studies. Blood biomarkers of vitamin D status. American Journal of Clinical Nutrition. 2008;87:4:1087s-1091s.

Bibliography
  1. Holick, M.F., Vitamin D Deficiency. The New England Journal Of Medicine, 2007. 357(3): p. 266-81.
  2. Yetley, E.A., Assessing the vitamin D status of the US population. 2008. 88(2): p. 558S-564S.
  3. Buffington, C., et al., Vitamin D deficiency in the morbidly obese. 1993. 3(4): p. 421-424.
  4. Parikh, S.J., et al., The relationship between obesity and serum 1, 25-dihydroxy vitamin D concentrations in healthy adults. 2004. 89(3): p. 1196-1199.
  5. Greene-Finestone, L.S., et al., 25-Hydroxyvitamin D in Canadian adults: biological, environmental, and behavioral correlates. Osteoporosis International: A Journal Established As Result Of Cooperation Between The European Foundation For Osteoporosis And The National Osteoporosis Foundation Of The USA, 2011. 22(5): p. 1389-99.
  6. Holick, M.F., et al., Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. The Journal Of Clinical Endocrinology And Metabolism, 2011. 96(7): p. 1911-30.
  7. Wortsman, J., et al., Decreased bioavailability of vitamin D in obesity. 2000. 72(3): p. 690-693.
  8. Mechanick, J.I., et al., Clinical practice guidelines for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient2013 update: cosponsored by American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery. Obesity (Silver Spring, Md ), 2013. 21 Suppl 1: p. S1-27.
  9. Hughes, B. Vitamin D deficiency in adults: Definition, clinical manifestations, and treatment. UpToDate 9/30/2019 [cited 10/21/2019; Available from: https://www.uptodate.com/contents/vitamin-d-deficiency-in-adults-definition-clinical-manifestations-and-treatment.

Revision History Information

Revision History DateRevision History NumberRevision History ExplanationReasons for Change
08/04/2022 R19

R20

Revision Effective: 08/04/2022

Revision Explanation: Annual Review, no changes were made.

  • Other (Annual Review)
07/29/2021 R18

R19

Revision Effective: 07/29/2021

Revision Explanation: Annual Review, no changes were made.

  • Other (Annual Review)
09/07/2020 R17

R18

Revision Effective: N/A

Revision Explanation: Annual Review, no changes.

  • Other (Annual Review)
09/07/2020 R16

R17
Revision Effective: 08/31/2020
Revision Explanation: Policy is being released to notice from the proposed policy that was presented in the open meeting 02/18/2020. 

  • Reconsideration Request
11/28/2019 R15

R16

Revision Effective: 11/28/2019

Revision Explanation: Entered incorrect revision. Converted back to previous version.

  • Other (Converted back to previous version.)
11/28/2019 R14

R15

Revision Effective: 11/28/2019

Revision Explanation: Added specific language to policy. Update of Summary of Evidence and Analysis of Evidence.

  • Reconsideration Request
11/07/2019 R13

R14

Revision Effective: 11/07/2019

Revision Explanation: Moved the information in the associated information section and the other comments section from the policy text into the billing and coding article.

10/29/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
09/26/2019 R12

R13

Revision Effective: 09/26/2019

Revision Explanation: Annual Review, no changes made

09/26/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual review, no changes)
09/19/2019 R11

R12

Revision Effective: 09/19/2019 Revision Explanation: Converted policy into new policy template that no longer includes coding section based on CR 10901. For Approval, no changes.

09/13/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Revisions Due To Code Removal
09/19/2019 R10

R11

Revision Effective: 09/19/2019 Revision Explanation: Converted policy into new policy template that no longer includes coding section based on CR 10901.

09/12/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Revisions Due To Code Removal
05/01/2017 R9

R10

Revision Effective: 8/15/2019

Revision Explanation: Removed all billing and coding details from policy into related Billing and Coding article. Coding information was removed based on CR10901.

08/15/2019-At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Removed billing and coding based on CR10901)
05/01/2017 R8

R9

Revision Effective: N/A

Revision Explanation: Annual review no changes made.

09/27/2018-At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

R8
Revision Effective: N/A
Revision Explanation: Annual review no changes made.

  • Other (Annual Review)
05/01/2017 R7

R7
Revision Effective: 05/01/2017
Revision Explanation:Adding dx: E67.8, E68, E84.0, E84.11, E84.19, E84.8, K50.00, K50.011, k50.012, k50.013, K50.014, K50.018, K50.111, K50.112, K50.113, K50.114, K50.118, K50.80, K50.811, K50.812, K50.813, K50.814, K50.818, K50.90, k50.911, K50.912, K50.913, K50.914, K50.918, K51.00, K51.011, K51.012, K51.013, K51.014, K51.018, K51.20, K51.211, K51.212, K51.213, K51.214, K51.218, K51.30, K51.311, K51.312, K51.313, K51.314, K51.318, K51.40, K51.411, K51.412, K51.413, K51.414, K51.418, K51.50, K51.511, K51.512, K51.513, K51.514, K51.518, K52.0, k70.2, K70.30, K70.31, K74.1, K74.3, K74.4, K74.69, M80.00XA, M80.011A, M80.012A,M80.021A, M80.022A, M80.031A, M80.032A, M80.041A, M80.042A, M80.051A, M80.052A, M80.061A, M80.062A, M80.071A, M80.072A, M80.08XA.

07/05/2017-At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Reconsideration Request
10/01/2016 R6 R6
Revision Effective: N/A
Revision Explanation: Annual review no changes made.
  • Other (Annual Review)
10/01/2016 R5 R5
Revision Effective:10/01/2016
Revision Explanation: Added new ICD-10 codes K90.41 and K90.49 that replaced K90.4.
  • Revisions Due To ICD-10-CM Code Changes
05/01/2016 R4 R4
Revision Effective:05/01/2016
Revision Explanation: Added the following indications and ICD-10 codes to correlate to additional indications for vitamin D testing:hypercalciura, malabsorption states, cirrhosis, hypervitaminosis D, obstructive jaundice, osteosclerosis/petrosis, and low exposure to sunlight.
  • Reconsideration Request
10/01/2015 R3 R3
Revision Effective:10/01/2015
Revision Explanation: Added M85.80 as showing medical necessity.
  • Reconsideration Request
10/01/2015 R2 R2
Revision Effective:10/01/2015
Revision Explanation: Added ICD-10 codes in the M85.8 series.
  • Reconsideration Request
10/01/2015 R1 R1
Revision Effective: N/A
Revision Explanation: Annual review no changes made.
  • Other (Annual Review)

Associated Documents

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Updated On Effective Dates Status
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07/23/2021 07/29/2021 - 08/03/2022 Superseded View
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