LCD L36692

Coverage Guidance

Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

42CFR410.32(a) requires a clinical diagnostic test be ordered by the physician who is treating the patient for a specific medical problem and uses the results in the management of the beneficiary’s specific problem.

MBPM Internet Only Manual(IOM 100-02), chap. 6, §20.4.3 applies 42CFR410.32 to hospitals.

Indications and Limitations of Coverage

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.

Summary of Evidence

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Analysis of Evidence

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Associated Information

Documentation must clearly indicate the necessity for the test(s), any and all repeat testing and frequency of testing.

The medical record must be made available to Medicare upon request.

Bibliography

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