Local Coverage Article Response to Comments

Response to Comments: Vitamin D Assay Testing


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Article ID
Article Title
Response to Comments: Vitamin D Assay Testing
Article Type
Response to Comments
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The comment period for the Vitamin D Assay Testing DL39391 Local Coverage Determination (LCD) began on 9/1/22 and ended on 10/15/22. The notice period for L39391 begins on 12/15/22 and will become effective on 1/29/23.

The comment below was received from the provider community.

Response To Comments


Thank you for the opportunity to review and comment on Palmetto’s proposed coverage policy for Vitamin D Assay Testing (DL39391).

As the world’s largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide.

We would like to express our thanks to Palmetto for their thoughtful evaluation of the medical literature related to Vitamin D testing. Pathology experts from the CAP’s Chemistry Resource Committee reviewed the proposed LCD and as a result, request that Palmetto also include measuring vitamin D levels for the following conditions in its final LCD. These are also consistent with other Medicare Administrative Contractor’s LCDs which has determined that testing for these conditions is reasonable and necessary, and that the evidence is sufficient for coverage.

Coverage Indications and Limitations

  1. Under the list of covered conditions for 25-hydroxyvitamin D (25(OH)D) testing, we respectfully request that the following conditions be added. Coverage for these is supported by the references already listed in the draft LCD bibliography and by additional references provided. 
    1. Fibromyalgia – Draft LCD ref. 29 and additional reference provided.
    2. Granuloma forming disorders - This is already included as being an appropriate intervention noted in the draft LCD ref. 18 and on page 6 of the draft LCD.
    3. Psoriasis - Draft LCD ref. 5
    4. Osteogenesis imperfecta – Alternatively, this may be listed as a subset of osteoporosis/secondary osteoporosis.
  2. The proposed policy also includes specific clinical situations when testing for deficiency of active vitamin D (1,25-Dihydroxyvitamin D) is considered to be reasonable and necessary. We respectfully request that sarcoidosis also be added to the list (draft LCD ref. 11). This condition is also noted in other Medicare Administrative Contractor’s LCDs.

Thank you again for the opportunity to review and comment on this proposed policy. We are happy to be of assistance in providing additional clinical or other information to assist you with this draft LCD.

References were provided for review.

We appreciate your thoughtful comments and will respond to each concern individually. Your references will be added to the Sources of Information.

  1. The request to add to the list of covered conditions
    1. Fibromyalgia - The article by Makrani et al. does demonstrate that there is a statistically significant decrease in Vitamin D levels of patients with fibromyalgia over control group in 851 patients. However, there was a large amount of heterogeneity between the studies, with differing inclusion and exclusion criteria. Moreover, this meta-analysis, as well as the reference 29 in the draft LCD (Ellis et al.) merely highlight an association between Vitamin D deficiency and fibromyalgia. As stated in the draft LCD, few high-quality interventional studies support a causal relationship between vitamin D deficiency and pain. This deficiency can instead be a surrogate of poor nutritional status and lack of outdoor activity associated with chronic illness. As such, the LCD will not be changed to expand coverage for fibromyalgia.
    2. Granuloma-forming disorders - The comments are appreciated. It is noted that the recommendation by the Endocrine Society, as noted in reference 11, does include a recommendation for Vitamin D testing for granuloma forming disorders such as Sarcoidosis, Tuberculosis, Histoplasmosis, Coccidiomycosis and Berylliosis. As such, language supporting this will be added to the LCD as well as the Billing and Coding Article.
    3. Psoriasis - The study by Filoni was an observational case control study with a small number of patients. Even the authors suggest that the association between Vitamin D levels and psoriasis is controversial. Even if the association is proven to be correct, there is still no evidence that the low levels is not merely a surrogate for low sun exposure due to cosmetic concerns. As such, the LCD will not be changed to expand coverage for psoriasis.
    4. Osteogenesis imperfecta - This condition is indeed a subset of osteoporosis, so the LCD will not be changed, but the ICD-10 code(s) will be added to the Billing and Coding Article.
  2. The request to add sarcoidosis to the list of conditions for testing of active vitamin D (1,25-Dihydroxyvitamin D)
    1. The comment is appreciated, and it is noted that the recommendation by the Endocrine Society, as noted in reference 11, does indeed state that measurement of 1,25(OH)2D is useful in acquired and inherited disorders in the metabolism of 25(OH)D and phosphate, including chronic kidney disease, hereditary phosphate-losing disorders, oncogenic osteomalacia, pseudo vitamin D-deficiency rickets, vitamin D-resistant rickets, as well as chronic granuloma forming disorders such as sarcoidosis. As such, sarcoidosis will be added to the LCD and the Billing and Coding Article.

Associated Documents

Related Local Coverage Documents
L39391 - Vitamin D Assay Testing
Related National Coverage Documents
Public Versions
Updated On Effective Dates Status
12/07/2022 12/15/2022 - N/A Currently in Effect You are here


  • Vitamin D
  • Vitamin D Assay Testing