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Local Coverage Determination (LCD)

Vitamin D Assay Testing

L34658

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L34658
Original ICD-9 LCD ID
Not Applicable
LCD Title
Vitamin D Assay Testing
Proposed LCD in Comment Period
N/A
Source Proposed LCD
N/A
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 10/01/2023
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
N/A
Notice Period End Date
N/A

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Issue

Issue Description

A biannual review was completed with no change in coverage.
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

Title XVIII of Social Security Act, Section 1861 Act provides for payment of clinical laboratory services under Medicare Part B. Clinical laboratory services involve the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

Title XVIII of Social Security Act, Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Title XVIII of Social Security Act, Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

42 CFR part 493, laboratory services must meet all applicable requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA), as set forth. Section 1862(a)(1)(A) provides that Medicare payment may not be made for services that are not reasonable and necessary.

42 CFR 410.32(a), clinical laboratory services must be ordered and used promptly by the physician who is treating the beneficiary.

42 CFR 410.32(a) (3), or by a qualified nonphysician practitioner.

CMS Pub 100-02, Medicare Benefit Policy Manual, Chapter 15 - Covered Medical and Other Health Care Services, §80.1 – Clinical Laboratory Services and 80.6 – Requirements for Ordering and Following Orders for Diagnostic Tests.

CMS Pub. 100-04, Medicare Claims Processing Manual, Chapter 1- General Billing Requirements, Sections 60 – Provider Billing of Non-covered Charges on Institutional Claims – 60.1.1 - Basic Payment Liability Conditions.

CMS Pub 100-04, Medicare Claims Processing Manual, Chapter 25 – Completing and Processing the Form CMS-1450 Data Set, Section 75.5 – From Locators 43-81, FL-67 Principal Diagnosis Codes.

CMS Transmittal No, 857, effective date October 3, 2018 Change Request 10901 Local Coverage Determinations (LCDs) Implementation date January 8, 2019.

Italicized font - represents CMS national language/wording copied directly from CMS Manuals or CMS Transmittals. Contractors are prohibited from changing national language/wording.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Vitamin D is a hormone, synthesized by the skin, the liver, and then metabolized by the kidney to an active hormone, calcitriol. An excess of vitamin D may lead to hypercalcemia. Vitamin D deficiency may lead to a variety of disorders. This LCD identifies the indications and limitations of Medicare coverage and reimbursement for these services.

Vitamin D is called a "vitamin" because of its availability from an exogenous source, predominantly from oily fish in the form of cholecalciferol, vitamin D3. Plant-based vitamin D is in the form of ergocalciferol, Vitamin D2. It is really a hormone, as it is synthesized by the skin, metabolized by the liver, and converted by the kidney to an active hormone, calcitriol. Calcitriol in its classical action, absorbs calcium from the intestine, and promotes bone mineralization.

In the skin, 7-dehydrocholesterol is converted to vitamin D3 in response to sunlight, a process that is inhibited by sunscreen with a skin protection factor (SPF) of 8 or greater. Once in the blood, vitamin D2 or D3 from diet, or D3 from skin production are carried by an alpha-2-globulin, vitamin D binding protein, and are carried to the liver where they are hydroxylated to yield 25-hydroxyvitamin D (25OHD; calcidiol). 25OHD then is converted in the kidney to 1, 25(OH)2D (calcitriol) by the action of 25OHD-1-alpha hydroxylase (CYP27B1). The CYP27B1 in the kidney is regulated by nearly every hormone involved in calcium homeostasis, and its activity is stimulated by PTH, estrogen, calcitonin, prolactin, growth hormone, low calcium levels, and low phosphorus levels. Its activity is inhibited by calcitriol, thus providing the feedback loop that helps regulates its synthesis.

An excess of vitamin D is unusual, but may lead to hypercalcemia. Vitamin D deficiency may lead to a variety of disorders; the well-described is rickets in growing children or osteomalacia in adults. Evaluating the status of a patient’s vitamin D sufficiency is accomplished by measuring the level of 25-hydroxyvitamin D. Measurement of other metabolites is generally not necessary outside of several unusual metabolic bone disorders or in chronic kidney disease-mineral bone disorder (CKD-MBD).

Indications:
Measurement of vitamin D levels is indicated for patients with:

  • chronic kidney disease stage III or greater;
  • osteoporosis;
  • osteomalacia;
  • osteopenia;
  • osteogenesis imperfecta;
  • osteosclerosis;
  • hypocalcemia;
  • hypercalcemia;
  • hypoparathyroidism;
  • hyperparathyroidism;
  • rickets;
  • vitamin D deficiency to monitor the efficacy of replacement therapy;
  • fibromyalgia;
  • granuloma forming diseases;
  • hypovitaminosis D;
  • hypervitaminosis D;
  • long term use of anticonvulsants or glucocorticoids and other medications known to lower - vitamin D levels;
  • malabsorption states;
  • obstructive jaundice;
  • cirrhosis;
  • psoriasis;
  • Paget’s disease of bone;
  • gastric bypass;
  • obesity.

Limitations:
For Medicare beneficiaries, screening tests are governed by statute (Social Security Act 1861 {nn}). Vitamin D testing may not be used for routine screening.

Assays of calcitriol need not be performed for each of the above conditions. The most common type of vitamin D deficiency is that of 25 OH Vitamin D.

The 1,25-dihydroxy form of vitamin D is generally only required to assist in the diagnosis of certain cases of rare endocrine disorders (primary hyperparathyroidism, hypothyroidism, pseudohypoparathyroidism), or for diagnosing and treating renal osteodystrophy and vitamin D-dependent and vitamin D resistant rickets, or in cases of unknown causes of hypercalcemia, including sarcoidosis. Level of both 25OHD and calcitriol are not needed as a panel for determining a patient's vitamin D status or to monitor routine vitamin D replacement therapy for most diseases. It is expected that the medical record will justify the tests chosen for a particular disease entity, that all available components of 25 OH vitamin D and other metabolite levels will not be performed routinely on every patient, and that supportive documentation for test choices will be available to the Contractor upon request.

This Contractor does not expect to receive billing for the various component sources of 25 OH vitamin D separately (such as stored D or diet derived D). Only one total 25 OH vitamin D assay (comprising the sum of both 25OHD2 and 25OHD3) will be considered for reimbursement on any particular day, if medically necessary, for the patient's condition.

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 for this vitamin deficiency, although, generally, other parameters are measured. Annual testing of the vitamin D status may be appropriate depending upon the indication and other mitigating factors. Because there can be variability in individual 25OHD responses to supplemental vitamin D in high-risk individuals, the serum 25OHD levels could be retested after about 3 months of supplementation to confirm that the target 25OHD level has been reached. If the follow up test shows they have not yet reached the target level, the test can be repeated in another 3 months until the target level is achieved.

Testing Methods
Several methods are available for measuring circulating concentrations of 25-OH-D. Medicare will cover laboratory tests that give practitioners accurate and reliable information. The method used to perform this testing should be validated.
Summary of Evidence

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Analysis of Evidence (Rationale for Determination)

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Proposed Process Information

Synopsis of Changes
Changes Fields Changed
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Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
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Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
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MAC Meeting Information URLs
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Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
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Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

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Revenue Codes

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CPT/HCPCS Codes

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ICD-10-CM Codes that Support Medical Necessity

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Group 1

Group 1 Paragraph:

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 Group 1 Codes:

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ICD-10-CM Codes that DO NOT Support Medical Necessity

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Group 1

Group 1 Paragraph:

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 Group 1 Codes:

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Additional ICD-10 Information

General Information

Associated Information

Documentation Requirements
The patient's medical record must contain documentation that fully supports the medical necessity for services included within this LCD. (See "Coverage Indications, Limitations, and/or Medical Necessity.") This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.

Utilization Guidelines
In accordance with CMS Ruling 95-1 (V. Acceptable Standards of Practice - Application), utilization of these services should be consistent with locally acceptable standards of practice.

  1. Only one 25 OH vitamin D level will be reimbursed in any 24 hour period. Storage and supplement components will not be reimbursed separately. 
  2. Only one 1,25-OH vitamin D level will be reimbursed in a 24 hour period if medically necessary. 
  3. Assays of vitamin D levels for conditions other than for Rickets, vitamin D deficiency, osteomalacia, and aluminum bone disease will be limited to once a year.
  4. Assays of the appropriate vitamin D levels for Rickets, vitamin D deficiency, osteomalacia, and aluminum bone disease will be limited to 4 per year, for the previously identified deficient form of vitamin D.

    (Because there can be variability in individual 25OHD responses to supplemental vitamin D in high-risk individuals, the serum 25OHD levels could be retested after about 3 months of supplementation to confirm that the target 25OHD level has been reached. If the follow up test shows they have not yet reached the target level, the test can be repeated in another 3 months until the target level is achieved.)
Sources of Information
N/A
Bibliography
  1. American Academy of Dermatology and AAD Association Position Statement on Vitamin D. (June 2009).
  2. Cannell JJ, Hollis BW, Zasloff M, Heaney RP. Diagnosis and treatment of vitamin D deficiency. Expert Opin Pharmacother. 2008;9(1):107-118.
    doi: 10.1517/14656566.9.1.107.
  3. Chocano-Bodeva P, Ronnenberg AG. Vitamin D and tuberculosis. Nutrition reviews. 2009;67(5):289-293.
    doi:10.1111/j.1753-4887.2009.00195.x
  4. LeFevre M L. Screening for vitamin D veficiency in adults: U.S. preventive services task force recommendation statement. Ann Intern Med. 2015;162(2):133-140.
    doi: 10.7326/M14-2450.
  5. Liu PT, Stenger S, Tang D.H, Modlin R L. Cutting edge: vitamin D-mediated human
    antimicrobial activity against mycobacterium tuberculosis is dependent on the induction of cathelicidin. The Journal of Immunology. 2007;179(4):2060-2063.
    doi: 10.4049/jimmunol.179.4.2060.
  6. Rollins, G. Vitamin D testing—what’s the right answer? labs grapple with confusing analytics, evidence. Clinical Laboratory News. 2009;35(7):1-9.
  7. Schleicher R L, Pfeiffer CM. Vitamin D testing how will we get it right? Clinical
    Laboratory News. 2009;35(12):1-10.
  8. Singh RJ. Are clinical laboratories prepared for accurate testing of 25-hydroxy vitamin D? Clinical Chemistry. 2008;54(1):221-223.
    doi: 10.1373/clinchem.2007.096156.

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
10/01/2023 R14

Posted 09/28/2023: Review completed 08/22/2023 with no change in coverage. No changes were made to the LCD.
  • Other (Review)
10/01/2021 R13

09/30/2021 Review completed 09/03/2021. Grammar and punctuation corrections made throughout the LCD. Relocated references listed under “Sources of Information” to “Bibliography”, and AMA formatting corrections made.
  • Other (Review)
10/31/2019 R12

10/31/2019 Change Request 10901 Local Coverage Determinations (LCDs): it will no longer be appropriate to include Current Procedure Terminology (CPT)/Health Care Procedure Coding System (HCPCS) codes or International Classification of Diseases Tenth Revision-Clinical Modification (ICD-10-CM) codes in the LCDs. All CPT/HCPCS, ICD-10 codes, and Billing and Coding Guidelines have been removed from this LCD and placed in Billing and Coding: Vitamin D Assay Testing linked to this LCD. Consistent with Change Request 10901 language from IOMs and/or regulations has been removed and the applicable manual/regulation has been referenced.
  • Other (Changes in response to CMS Change Request 10901)
10/01/2019 R11

09/26/2019: Group 1 Codes: removed Z68.30-Z68.45 from code range and listed individually. ICD-10 CM code annual update in Group 1 Codes: Z68.43 description change. Review completed 09/03/2019.
  • Revisions Due To ICD-10-CM Code Changes
  • Other ((Annual Review))
10/01/2018 R10

10/01/2018 Annual review done 08/31/2018. ICD-10 code updates: description change to code Z68.43; deleted codes K83.0 and M79.1; and added codes K82.A1, K82.A2, K83.01, K83.09, M79.10, M79.11, M79.12, and M79.18.
  • Revisions Due To ICD-10-CM Code Changes
  • Other (Annual Review)
10/01/2017 R9

 10/01/2017 Annual review done 09/02/2017. Per ICD-10 code updates: To Group 1 description changes to codes M33.01, M33.02, M33.09, M33.11, M33.12, and M33.19; and added codes M3303, M33.13, and M33.93.

 
  • Revisions Due To ICD-10-CM Code Changes
  • Other (Annual Review)
09/01/2017 R8

09/01/2017: Added the following codes to Group 1 for 82306: B38.0-B38.89, B39.0-B39.5, C82.00-C82.99, J63.2, M80.00XA-M80.88XS, Z68.30-Z68.45, and Z98.0. Added “obesity” to the list of indications for the measurement of vitamin D levels in the narrative section. At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.
  • Revisions Due To ICD-10-CM Code Changes
10/01/2016 R7 10/01/2016 Annual review done. Per ICD-10 Code Updates: in Group 1 deleted codes K85.1, K86.8, and K90.4 and added codes K85.10, K85.11, K85.12, K86.81, K86.89, K90.41, and K90.49, effective 10/01/2016.
  • Other (Annual Review)
  • Revisions Due To ICD-10-CM Code Changes
10/01/2015 R6 12/01/2015 Added codes C22.0, C22.1, C22.2, C22.3, C22.4, C22.7, C22.8, C22.9, C23, C24.0, C24.1, C24.8, C24.9, C25.0, C25.1, C25.2, C25.3, C25.4, C25.7, C25.8, C25.9, C26.0, C26.1, C26.9, D13.0, D13.1, D13.2, D13.30, D13.39, D13.4, D13.5, D13.6, D13.7, D13.9, K80.01, K80.11, K80.13, K80.19, K80.21, K80.31, K80.33, K80.35, K80.37, K80.41, K80.43, K80.45, K80.47. K80.51, K80.61, K80.63, K80.65, K80.67, K80.71, K80.81, K82.0, K82.8, K82.9, K83.0, K83.1, K83.2, K83.3, K83.4, K83.5, K83.8, K83.9, K85.1, K86.2, K86.3, K86.8, K86.9, K87, M85.80, M85.811, M85.812, M85.821, M85.822, M85.831, M85.832, M85.841, M85.842, M85.851, M85.852, M85.861, M85.862, M85.871, M85.872, M85.88, and M85.89 to Group 1 table with an effective date of 10/01/2015. Removed CAC information. Formatting changes made.
  • Other (ICD-10 Code Update

    )
  • Revisions Due To ICD-10-CM Code Changes
10/01/2015 R5 10/06/2015 - Due to CMS guidance, we have removed the Jurisdiction 8 Notice and corresponding table from the CMS National Coverage Policy section. No other changes to policy or coverage.
  • Other
10/01/2015 R4 10/01/2015 Annual review done. Formatting changes made. Updated Sources of Information. No change in coverage.
  • Other (Annual review)
10/01/2015 R3 10/01/2014: Annual review done 09/09/2014. Formatting and punctuation changes made. Sources of Information updated. No change in coverage.
  • Other
10/01/2015 R2 07/01/2014 For clarity, added the ICD-10 codes for vitamin D deficiency E55.0, E55.9, E64.3, M83.0 – M83.5, and M83.8 – M83.9 under the utilization guidelines. Theses codes already appear in the chart of Group 2 codes. No change in coverage.
  • Other
10/01/2015 R1 04/01/2014 Removed reference to ICD-9 and changed to ICD-10. No change in coverage.
  • Typographical Error
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Associated Documents

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Related Local Coverage Documents
Articles
A57484 - Billing and Coding: Vitamin D Assay Testing
Related National Coverage Documents
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