CMS Local Coverage Determination (LCD)

CMS Vitamin D Assay Testing Form


Vitamin D Assay Testing

Indications

(45002) Does the patient have chronic kidney disease stage III or greater? 
(45003) Does the patient have cirrhosis? 
(45004) Does the patient have hypocalcemia? 
(45005) Does the patient have hypercalcemia? 
(45006) Does the patient have hypercalciuria? 
(45007) Does the patient have hypervitaminosis D? 
(45008) Does the patient have parathyroid disorders? 
(45009) Does the patient have malabsorption states? 
(45010) Does the patient have obstructive jaundice? 
(45011) Does the patient have osteomalacia? 
(45012) Does the patient have osteoporosis with a T score on DEXA scan less than -2.5? 
(45013) Does the patient have osteoporosis with a history of fragility fractures? 
(45014) Does the patient have osteoporosis with FRAX greater than 3% 10-year probability of hip fracture OR 20% 10-year probability of other major osteoporotic fracture? 
(45015) Does the patient have osteoporosis with FRAX greater than 3% (any fracture) AND a T-score less than -1.5? 
(45016) Is the patient initiating bisphosphonate therapy? 
(45017) Does the patient have osteosclerosis/petrosis? 
(45018) Does the patient have rickets? 
(45019) Is the patient on vitamin D replacement therapy related to a condition listed above? 
(45020) Does the patient have unexplained hypercalcemia suspected of granulomatous disease or lymphoma? 
(45021) Does the patient have unexplained hypercalciuria suspected of granulomatous disease or lymphoma? 
(45022) Does the patient have suspected genetic childhood rickets? 
(45023) Does the patient have suspected tumor-induced osteomalacia? 
(45024) Does the patient have nephrolithiasis or hypercalciuria? 

Contraindications

(45025) Is the testing being used for routine or other non-medically necessary screening purposes? 
(45026) Has the patient already been shown to be vitamin D deficient and the current testing is for ensuring adequate replacement? 
(45027) Is the patient's Vitamin D level between 20 and 50 ng/ml and the patient clinically stable? 
(45028) If previously Vitamin D deficient, is the subsequent level within the normal range after replacement? 
Effective Date

12/01/2019

Last Reviewed

04/01/2022

Original Document

  Reference



Background for this Policy

Summary Of Evidence

N/A

Analysis of Evidence

N/A

Vitamin D is called a "vitamin" because of its exogenous source, predominately from oily fish in the form of vitamin D 2 and vitamin D 3. It is more accurate to consider fat-soluble Vitamin D as a steroid hormone, synthesized by the skin and metabolized by the kidney to an active hormone, calcitriol. Clinical disorders related to vitamin D may arise because of altered availability of the parent vitamin D, altered conversion of vitamin D to its predominant metabolites, altered organ responsiveness to dihydroxylated metabolites and disturbances in the interactions of the vitamin D metabolites with PTH and calcitonin. Normal levels of Vitamin D range from 20 – 50 ng/ml. This LCD identifies the indications and limitations of Medicare coverage and reimbursement for the lab assay.

Indications:

Measurement of 25-OH Vitamin D level is indicated for patients with:

    • chronic kidney disease stage III or greater
    • cirrhosis
    • hypocalcemia
    • hypercalcemia
    • hypercalciuria
    • hypervitaminosis D
    • parathyroid disorders
    • malabsorption states
    • obstructive jaundice
    • osteomalacia
      • osteoporosis if
            • i. T score on DEXA scan <-2.5 or
            ii. History of fragility fractures or
            iii. FRAX > 3% 10-year probability of hip fracture or 20% 10-year probability of other major osteoporotic fracture or
            iv. FRAX > 3% (any fracture) with T-score <-1.5 or
            v. Initiating bisphosphanate therapy (Vitamin D level should be determined and managed as necessary

before bisphosphonate is initiated)

  • osteosclerosis/petrosis
  • rickets
  • vitamin D deficiency on replacement therapy related to a condition listed above; to monitor the efficacy of treatment.


Measurement of 1, 25-OH Vitamin D level is indicated for patients with:

    • unexplained hypercalcemia (suspected granulomatous disease or lymphoma)
    • unexplained hypercalciuria (suspected granulomatous disease or lymphoma)
    • suspected genetic childhood rickets
    • suspected tumor-induced osteomalacia
  • nephrolithiasis or hypercalciuria


Limitations:

Testing may not be used for routine or other screening.

Both assays of vitamin D need not be performed for each of the above conditions. Often, one type is more appropriate for a certain disease state than another. The most common type of vitamin D deficiency is 25-OH vitamin D. A much smaller percentage of 1, 25-dihydroxy vitamin D deficiency exists; mostly, in those with renal disease. Although it is not the active form of the hormone, 25-OH vitamin D is much more commonly measured because it better reflects the sum total of vitamin D produced endogenously and absorbed from the diet than does the level of the active hormone 1, 25-dihydroxy vitamin D. Deficiency of 1, 25-dihydroxy vitamin D, which is present at much lower concentrations, does not necessarily reflect deficiency of 25-OH vitamin D and its measurement should be limited to the indications listed. Documentation must justify the test(s) chosen for a particular disease entity. Various component sources of 25-OH vitamin D, such as stored D or diet-derived D, should not be billed separately.

Once a beneficiary has been shown to be vitamin D deficient, further testing may be medically necessary only to ensure adequate replacement has been accomplished. If Vitamin D level is between 20 and 50 ng/ml and patient is clinically stable, repeat testing is often unnecessary; if performed, documentation most clearly indicate the necessity of the test. If level <20 ng/ml or > 60 ng/ml, a subsequent level(s) may be reimbursed until the level is within the normal range.