Local Coverage Article Response to Comments

Response to Comments: Vitamin D Assay Testing


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Response to Comments: Vitamin D Assay Testing
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Response to Comments
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As an important part of Medicare Local Coverage Determination (LCD) development, National Government Services solicits comments from the provider community and from members of the public who may be affected by or interested in our LCDs. The purpose of the advice and comment process is to gain the expertise and experience of those commenting.

We would like to thank those who suggested changes to the LCD for Vitamin D Assay testing. The official notice period for the final LCD begins on February 14, 2018 and the final determination will become effective on April 1, 2018.

Response To Comments


One commenter stated that the CKD stage should be II or greater.

Vitamin D is often prescribed as a supplement to  prevent the compensatory rise in PTH. Prescribing earlier in the disease may be of some value. The comment is accepted, but does not alter the general guidelines for prescribing within the policy.





One Commenter asked if NGS would be willing to expand the indications to include lupus?

Review of the literature and discussion with subject matter experts finds the direct linkage between the various forms of lupus and Vitamin D disturbance tenuous. The most consistent direct relationship is with the presence of proteinuria, for which a coding convention is already present. 

What is also clinically evident is the relationship of disease consequences and co-morbidities. 

Whether avoidance of sunlight, immobility, medications, dermatologic manifestations or others, there is almost always a specific (and already included) diagnosis that justifies the testing at an appropriate interval. Sakisthwary and Raymond; found an inverse relationship between Vitamin D levels and SLE disease activity in 10 of 22 papers reviewed. However, they also found a concurrent direct relationship with cardiovascular disease in 3 papers, and no direct relationship with organ damage related to SLE in 5 of 6 papers. 

Sakthiswary R, Raymond AA. The clinical significance of vitamin D in systemic lupus erythematosus: a systematic review. PLoS One. 2013;8(1):e55275.

Sahebari M, Nabavi N, Salehi M. Correlation between serum 25(OH)D values and lupus disease activity: an original article and a systematic review with meta-analysis focusing on serum VitD confounders. Lupus. 2014;23(11):1164-1177.

Lima GL, Paupitz JA, Aikawa NE, Alvarenga JC, Pereira RMR. A randomized double-blind placebo-controlled trial of vitamin D supplementation in juvenile-onset systemic lupus erythematosus: positive effect on trabecular microarchitecture using HR-pQCT. Osteoporos Int. 2017.

Dall'Ara F, Cutolo M, Andreoli L, Tincani A, Paolino S. Vitamin D and systemic lupus erythematous: a review of immunological and clinical aspects. Clin Exp Rheumatol. 2017.

Salman-Monte TC, Torrente-Segarra V, Vega-Vidal AL, et al. Bone mineral density and vitamin D status in systemic lupus erythematosus (SLE): A systematic review. Autoimmun Rev. 2017;16(11):1155-1159.

Rossini M, Gatti D, Viapiana O, et al. Vitamin D and rheumatic diseases. Reumatismo. 2014;66(2):153-170.

Karimzadeh H, Shirzadi M, Karimifar M. The effect of Vitamin D supplementation in disease activity of systemic lupus erythematosus patients with Vitamin D deficiency: A randomized clinical trial. J Res Med Sci. 2017;22:4.



One commenter stated that mental health conditions/symptoms such as mood disorders or depression are not listed as conditions qualifying for medical necessity for this lab test.

PCP’s will order a Vitamin D lab test when these conditions/symptoms exist and quite often the lab value falls far below the expected normal range. There is no reference to Vitamin D testing in the Psychiatric LCD L33632, either.

This recent 2016 study refers to institutionalized populations, it also may apply to current Medicare beneficiaries.


While this 2006 study reflects a correlation between low Vitamin D and low mood/decreased cognition in the elderly population,  it also may apply to current Medicare beneficiaries.


The two articles appended to this comment have been added to the bibliography. Similar to the discussion of lupus, the disorders of mood and behavioral diagnoses such as depression are often manifested in medical co-morbidities. Disorders of nutrition, eating disorders, medication side effects and impact on appetite are all frequent features of behavioral disturbances. Most of the clinical symptoms associated with mental health conditions are already included in the policy.  Those clinical circumstances referred to by the commenter, i.e. when the primary physician documents low Vitamin D levels in response to this symptom complex, should be followed up in the usual fashion.  Regarding absolute correlation between behavioral disorders, and vitamin D level, the direct causality remains in question. At the present time, clinicians are directed to code per the medical co-morbidity, most of which are listed in the policy.  

Bazzano AN, Littrell L, Lambert S, Roi C. Factors associated with vitamin D status of low-income, hospitalized psychiatric patients: results of a retrospective study. Neuropsychiatr Dis Treat. 2016;12:2973-2980.

Wilkins CH, Sheline YI, Roe CM, Birge SJ, Morris JC. Vitamin D deficiency is associated with low mood and worse cognitive performance in older adults. Am J Geriatr Psychiatry. 2006;14(12):1032-1040.



The College of American Pathologists (CAP) appreciates NGS’ willingness to cover vitamin D testing in accordance with the U.S. Preventive Services Task Force (USPSTF) and Choosing Wisely recommendations on screening for vitamin D deficiency, and for taking into account the view of physicians practicing in relevant clinical areas along with other sources when developing this policy.

Given the level of evidence at this time, the CAP agrees with the coverage that is outlined in the proposed policy.

The comment from the College of American Pathologists is appreciated.



One commenter stated that the proposed draft follows well established clinical guidelines, is clear and concise.



The comment from this clinician is appreciated.


One commenter stated that these diagnoses were in the LCD prior to the draft and we are requesting that they be included:

M80.00XA through M80.88XS (range of osteoporosis diagnosis codes)

M81.6 Localized osteoporosis [Lequesne]

M85.831 Other specified disorders of bone density and structure, right forearm

M85.832 Other specified disorders of bone density and structure, left forearm

M85.839 Other specified disorders of bone density and structure, unspecified forearm

M85.851 Other specified disorders of bone density and structure, right thigh

M85.852 Other specified disorders of bone density and structure, left thigh

M85.859 Other specified disorders of bone density and structure, unspecified thigh

M85.89 Other specified disorders of bone density and structure, multiple sites

M85.9 Disorder of bone density and structure, unspecified

M89.9 Disorder of bone, unspecified

ICD-10 codes Z68.30 through Z68.45 which represent a BMI measurement of 30 or greater. Since these BMI values are generally associated with a diagnosis of “obesity” we ask that NGS also include as covered diagnoses the following ICD-10-CM codes that represent “obesity”:

E66.01 Morbid (severe) obesity due to excess calories

E66.09 Other obesity due to excess calories

E66.1 Drug-induced obesity

E66.2 Morbid (severe) obesity with alveolar hypoventilation

E66.8 Other obesity

E66.9 Obesity, unspecified

Orders for laboratory tests frequently include only a single diagnosis; therefore if NGS’ intention is to cover Vitamin D testing for obese patients (i.e. with BMI >= 30) then NGS should not limit the list of covered diagnoses to only the BMI Z-codes which would not be reported as standalone diagnoses. 

In a recent publication, Obesity and Vitamin D deficiency: a Systemic Review and Meta-Analysis, Pereira-Santos et al, Vitamin D Deficiency is associated with obesity, irrespective of age, latitude, and cut-offs to define vitamin D deficiency and the Human Development Index of the study location. The request for continued inclusion of these codes is supported, as is the range of osteoporosis codes (also previously included.)

Pereira-Santos M, Costa PR, Assis AM, Santos CA, Santos DB. Obesity and vitamin D deficiency: a systematic review and meta-analysis. Obes Rev. 2015;16(4):341-349. 


One commenter included a supporting study demonstrating that active Vit D (aka 1,25-OH Vit D) is deficient in a large number of kidney transplant patients. According to Dr. Chobanian, up to a third of these patients have a 1,25-OH Vit D deficiency unrelated to nutritional deficit (i.e. normal values of 25-hydroxy Vit D) following their transplant.

The transplant surgery service at Dartmouth-Hitchcock recommends extending coverage of 1,25-OH Vit D testing to kidney transplant recipients at 6 and 12 months post-transplant, as these patients are at highest risk for deficiency in this first year. Their current practice is to stop measuring 1,25-OH Vit D levels if a patient is started on calcitriol, but they continue to measure PTH levels annually until these normalize. 

The article has been reviewed and added to the bibliography. The rationale of 1,25-OH Vitamin D testing at 6 and 12 months post-transplant is supported by the independence of the finding from nutritional deficit. The practice of initiation of calcitriol, cessation of the Vit D testing, and following annual PTH levels is judicious clinical practice and appropriate coding has been added to the policy. 

Falkiewicz K, Boratynska M, Speichert-Bidzinska B, et al. 1,25-dihydroxyvitamin D deficiency predicts poorer outcome after renal transplantation. Transplant Proc. 2009;41(8):3002-3005.


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