CMS Assays for Vitamins and Metabolic Function Form

Summary Of Evidence

N/A

Analysis of Evidence

N/A

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

Covered Indications

Medicare generally considers vitamin assay panels (more than one vitamin assay) a screening procedure and therefore, non-covered. Similarly, assays for micronutrient testing for nutritional deficiencies that include multiple tests for vitamins, minerals, antioxidants and various metabolic functions are never necessary. Medicare reimburses for covered clinical laboratory studies that are reasonable and necessary for the diagnosis or treatment of an illness. Many vitamin deficiency problems can be determined from a comprehensive history and physical examination. Any diagnostic evaluation should be targeted at the specific vitamin deficiency suspected and not a general screen. Most vitamin deficiencies are nutritional in origin and may be corrected with supplemented vitamins.

Most vitamin deficiencies are suggested by specific clinical findings. The presence of those specific clinical findings may prompt laboratory testing for evidence of a deficiency of that specific vitamin. Certain other clinical states may also lead to vitamin deficiencies (malabsorption syndromes, etc.).

Limitations:

For Medicare beneficiaries, screening tests are governed by statute. Vitamin or micronutrient testing may not be used for routine screening.

Once a beneficiary has been shown to be vitamin 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.

Notice: This LCD imposes the following limitations to the tests addressed in this LCD. Refer to the companion article Billing and Coding: Assays for Vitamins and Metabolic Function, A56416, for all coding information. These limitations will support automated denials as follows:

• Diagnosis to procedure limitations only for cellular function assays involving stimulation and detection of biomarker
• Frequency limitations** only for:
  • Assay of ascorbic acid
  • Assay of vitamin b-2
  • Assay of vitamin b-1
  • Assay of vitamin e
  • Assay of vitamin a
  • Assay of vitamin k
• Diagnosis to procedure and frequency limitations** for:
  • Vitamin d 25 hydroxy
  • Assay of carnitine
  • Vitamin b-12
  • Vitamin d 1 25-dihydroxy
  • Assay of folic acid serum
  • Assay of homocysteine
  • Assay lipoprotein pla2
  • Assay of vitamin b-6
  • Fibrinogen antigen

**Note: This LCD imposes frequency limitations. Please refer to the Utilization Guidelines section for an outline of the frequency limitations. Frequency limitations do not establish medical necessity for all testing but does reflect how the medical community uses the tests. Patterns of billing will be monitored for potential utilization of these tests for screening purposes, either by use of a single test or multiple tests together. 

Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.

The redetermination process may be utilized for consideration of services performed outside of the reasonable and necessary requirements in this LCD.