Archive
API

Local Coverage Determination (LCD)

Vitamin D; 25 hydroxy, includes fraction(s), if performed

L33771

Expand All | Collapse All
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
L33771
Original ICD-9 LCD ID
Not Applicable
LCD Title
Vitamin D; 25 hydroxy, includes fraction(s), if performed
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL33771
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 10/29/2020
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
N/A
Notice Period End Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

Issue

Issue Description
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for Vitamin D; 25 hydroxy, includes fraction(s), if performed. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for Vitamin D; 25 hydroxy, includes fraction(s), if performed and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site.

Internet Only Manual (IOM) Citations:

  • CMS IOM Publication 100-04, Medicare Claims Processing Manual,
    • Chapter 16, Section 120.1 Negotiated Rulemaking Implementation
  • CMS IOM Publication 100-08, Medicare Program Integrity Manual,
    • Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD

Social Security Act (Title XVIII) Standard References:

  • 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.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

History/Background and/or General Information

Vitamin D, a group of fat-soluble prohormones, is an essential Vitamin. There are two major types of Vitamin D (Vitamin D2 and Vitamin D3) which are collectively known as calciferol. They are essential for promoting calcium absorption and maintaining adequate serum calcium and phosphate concentrations to enable mineralization of bone and prevent hypocalcemic conditions. Vitamin D2 (ergocalciferol) is obtained from foods of plant origin and vitamin D3 (cholecalciferol) is obtained from foods of animal origin and ultraviolet light-stimulated conversion of 7-dehydrocholesterol in the skin. Vitamin D is stored in the human body as calcidiol (25-hydroxyvitamin D). Serum concentration of 25(OH) D is the best indicator of Vitamin D status.

Vitamin D deficiencies are the result of dietary inadequacy, impaired absorption and use, increased requirement, or increased excretion. Vitamin D deficiency can occur when usual intake is lower than recommended levels over a period of time, or when exposure to sunlight is limited. Vitamin D deficiency can also result from the inability of the kidneys to convert the Vitamin D to its active form.

There is robust evidence supporting skeletal benefits at a Vitamin D level of 20 ng/mL (50 nmol/L). There is clinical evidence that to achieve non-skeletal benefits of Vitamin D, a level of 30 ng/mL (75 nmol/L) may be required. Currently, the Endocrine Society is endorsing a level of 30 ng/mL (75 nmol/L). Vitamin D deficiency in high risk adults is identified as serum concentration of 25(OH) D <30 ng/mL (75 nmol/L). Vitamin D toxicity can cause symptoms including nausea, vomiting, poor appetite, constipation, weakness, and weight loss as well as elevation in the blood level of calcium which in turn can lead to mental status changes, and heart rhythm abnormalities. Patients receiving Vitamin D supplementation should also be assessed for Vitamin D toxicity and disorders of calcium and phosphorus metabolism.

Covered Indications

The measurement of 25(OH) Vitamin D levels will be considered medically reasonable and necessary for patients with any of the following conditions:

  • Chronic kidney disease stage III or greater
  • Hypercalcemia
  • Hypocalcemia
  • Hyperparathyroidism
  • Hypoparathyroidism
  • Osteomalacia
  • Osteoporosis
  • Osteopenia
  • Rickets
  • Vitamin D deficiency to monitor the efficacy of replacement therapy
  • Malabsorption states
  • Cirrhosis (biliary, hepatic)
  • Tuberculosis
  • Histoplasmosis
  • Coccidioidomycosis
  • Berylliosis
  • Follicular lymphoma
  • Immunodeficiency with predominantly antibody defects
  • Sarcoidosis
  • Hyperalimentation
  • Cystic fibrosis
  • Inflammatory Bowel Disease (Crohns, Ulcerative Colitis)
  • Radiation enteritis
  • Liver cirrhosis
  • Psoriasis
  • Systemic Lupus Erythematosus
  • Myositis
  • Obesity
  • Bariatric surgery
  • Long-term use of medications known to lower vitamin D levels


Limitations

  • Only one 25 OH Vitamin D level will be reimbursed in any 24 hour period. 
  • Patients with conditions outlined in the indications (acute and high risk conditions associated with Vitamin D deficiency) are candidates for testing. Consider repeat testing in 3-4 months after starting replacement therapy and reassessing if levels < 30 ng/mL (75 nmol/L).
  • It’s not reasonable and necessary to perform more than three tests per year.
  • Patients with Vitamin D deficiency that have been supplemented to normal levels are limited to one test per year. 


This LCD outlines the indications for Vitamin D, 25-hydroxy. This test is appropriate for assessment of Vitamin D deficiency. Vitamin D, 1,25-dihydroxy is primarily indicated during patient evaluations for hypercalcemia and renal failure. It should not be ordered in addition to Vitamin D, 25-hydroxy for Vitamin D deficiency testing.

Please refer to CMS IOM Publication 100-04, Medicare Claims Processing Manual, Chapter 16, Section 120.1 for additional limitations for Vitamin D assay testing.

As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary.
Summary of Evidence

N/A
Analysis of Evidence (Rationale for Determination)

N/A

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
N/A
Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
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
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description
N/A

Revenue Codes

Code Description
N/A

CPT/HCPCS Codes

Expand All | Collapse All

Group 1

Group 1 Paragraph

N/A

 Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

Expand All | Collapse All

Group 1

Group 1 Paragraph:

N/A

 Group 1 Codes:

N/A

N/A

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

Expand All | Collapse All

Group 1

Group 1 Paragraph:

N/A

 Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information


Refer to the Local Coverage Article: Billing and Coding: Vitamin D; 25 hydroxy, includes fraction(s), if performed, A56841 for documentation requirements, utilization parameters and all coding information.
Sources of Information


First Coast Service Options Inc. reference LCD number(s) – L30868
Bibliography

 

  1. Bishoff-Ferrari HA, Dawson-Hughes B, Willet W, et al. Effect of Vitamin D on falls: a meta-analysis. JAMA. 2004; 291(16):1999-2006. Accessed December 29, 2009.
  2. Bishoff-Ferrari HA, Willett W, Wong J, Giovannucci E, Eietrich T, Dawson-Hughes B. Fracture prevention with Vitamin D supplementation: a meta-analysis of randomized controlled trials. JAMA. 2005; 293(18):2257-2264. Accessed December 29, 2009.
  3. Greene-Finestone LS, Berger C, de Groh M, et al. 25-Hydroxyvitamin D in Canadian adults: biological, environmental, and behavioral correlates. Osteoporos Int. 2011;22:1389–1399.
  4. Holick MF, Binkley NC, Bischoff-Ferrari HA, et al. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011; 96:1911–1930.
  5. Holick MF. Vitamin D deficiency. N Engl J Med. 2007;357:266–281.
  6. Lawrence Leah. Vitamin D levels may be linked with follicular lymphoma outcomes. Oncol. Cancer Network Website. Accessed April 5, 2017.
  7. National Kidney Foundation. Clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Am J Kidney Dis. 2003 Oct;42(Suppl 3):1-201. Accessed October 26, 2009. 
  8. National Osteoporosis Foundation. Clinician’s guide to prevention and treatment of osteoporosis. J Clin Densitom. 2008 Oct-Dec;11(4)473-7. Accessed October 26, 2009.
  9. Nichols J. The controversy surrounding Vitamin D lab testing. Washington G-2 Reports. 2008. Retrieved October 22, 2009.Nicholson I, Dalzell AM, El-Matary W. Vitamin D as a therapy for colitis: A systemic review. J of Crohn’s and Colitis. 2012;6(4) 405-411.
  10. Office of Dietary Supplements (ODS), National Institutes of Health (NIH). Dietary Supplement Fact Sheet: Vitamin D. NIH Website. Accessed December 23, 2009.

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
10/29/2020 R13

LCD revised and published on 10/29/2020. Title XVIII of the Social Security Act, Section 1833(e) reference, CPT codes 82306 and 82652 removed from LCD to comply with CR 10901, also LCD was updated to be consistent with GWS template.
  • Other (To comply with CR 10901 and new GWS template.)
01/08/2019 R12

10/02/2019:  The content in the LCD was revised to be consistent with the new format supported by CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.1.
  • Other (Revisions based on CR 10901)
01/08/2019 R11

Revision Number: 10
Publication: August 2019 Connection
LCR A/B2019-045

Explanation of Revision: Based on CR 10901, the LCD was revised to remove all billing and coding and all language not related to reasonable and necessary provisions (“Bill Type Codes”, “Revenue Codes”, “CPT/HCPCS Codes”, “ICD-10 Codes that Support Medical Necessity”, “Documentation Requirements” and “Utilization Guidelines” sections of the LCD) and place them into a newly created billing and coding article. During the process of moving the ICD-10-CM diagnosis codes to the billing and coding article, the ICD-10-CM diagnosis code ranges were broken out and listed individually. The effective date of this revision is for claims processed on or after January 8, 2019, for dates of service on or after October 3, 2018.

01/08/2019: 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 LCD.
  • Other (Revisions based on CR 10901)
10/01/2018 R10

Revision Number: 9
Publication: September 2018 Connection
LCR A/B2018-074

Explanation of Revision: Based on CR 10847 (Annual 2019 ICD-10-CM Update), the LCD was revised. Deleted ICD-10-CM diagnosis code M79.1. Added ICD-10-CM diagnosis code range M79.11-M79.18. The effective date of this revision is based on date of service.

10/01/2018: 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 LCD.
  • Revisions Due To ICD-10-CM Code Changes
05/15/2018 R9

Revision Number: 8

Publication: May 2018 Connection

LCR A/B2018-045

Explanation of Revision: Based on an annual review of the LCD, it was determined that some of the italicized language in the “Coverage Indications, Limitations, and/or Medical Necessity” section of the LCD does not represent direct quotation from a CMS source listed in the LCD; therefore, this LCD is being revised to assure consistency with the CMS source. The effective date of this revision is based on date of service.

05/15/2018:  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.
  • Other (Revisions based on annual review completed on 02/28/2018.)
02/08/2018 R8

Revision Number: 7

Publication: February 2018 Connection

LCR A/B2018-012

Explanation of Revision: This LCD was revised in the “ICD-10 Codes that Support Medical Necessity” section of the LCD under “Group 1 Medical Necessity ICD-10 Codes Asterisk Explanation:” to include an explanation that all the codes within the asterisked range from the first code to the last code apply. The effective date of this revision is based on process date.

02/08/2018:  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.
  • Provider Education/Guidance
  • Public Education/Guidance
10/01/2017 R7

Revision Number: 6

Publication: September 2017 Connection 

LCR A/B2017-038

Explanation of Revision: Based on CR 10153 (Annual 2018 ICD-10-CM Update) the LCD was revised. Descriptor revised for ICD-10-CM diagnosis code M33.00. The effective date of this revision is based on date of service.

 

10/01/2017:  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
06/22/2017 R6

Revision Number: 5 Publication: June 2017 Connection LCR A/B2017-022


Explanation of Revision: Based on CR 8776, the following verbiage was removed from the “CPT/HCPCS Codes” section of the LCD: “Per CR 8572, beginning in CY 2014, payment for most laboratory tests (except for molecular pathology tests) will be packaged under the OPPS, therefore the clinical laboratory tests listed below, for TOB 13X (outpatient hospital), are packaged in this setting.” The effective date of this revision is for claims processed on or after 05/12/2017, for dates of service on or after 01/01/2014. In addition, based on a reconsideration request multiple indications were added to the “Indications and Limitations of Coverage and/or Medical Necessity” section of the LCD and supporting ICD-10-CM codes A15.0—A19.9, B38.1— B38.9, B39.1— B39.9, C82.00— C82.99, D80.0— D80.9, D86.0— D86.9, D89.810— D89.813, E67.8, E68, E83.59, E84.0, E84.19— E84.8, G73.7, J63.2, K50.00— K51.319, K51.50—K52.0, K74.1, K74.2, K83.8, K86.0— K86.1, K86.81— K86.89, K87, K90.81, L40.0— L40.9, M32.0— M32.9, M33.00— M33.99, M36.0, M60.80— M60.9, M79.1, M79.7, M81.6, M85.80, Q78.0, Q78.2, Z68.30-Z68.45, *Z79.3, *Z79.51—*Z79.52, *Z79.891—*Z79.899, Z98.0, and Z98.84 were added to the “ICD-10 Codes that Support Medical Necessity” section of the LCD. Also, the Sources of Information section was updated. The effective date of this revision is based on dates of service on or after 06/22/2017.
  • Provider Education/Guidance
  • Reconsideration Request
10/01/2016 R5 Revision Number: 4 Publication: October 2016 Connection
LCR A/B2016-097

Explanation of Revision: Based on CR 9677 (Annual 2017 ICD-10-CM Update) the LCD was revised. Revised ICD-10 diagnoses code range K90.0-K90.4 to read K90.0-K90.49. Deleted diagnosis code K90.4. The effective date of this revision is based on date of service.
  • Revisions Due To ICD-10-CM Code Changes
06/30/2016 R4 Revision Number: 3
Publication: July 2016 Connection
LCR A/B2016-077
Explanation of revision: This LCD was revised to add ICD-10-CM diagnosis codes 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 the “ICD-10 Codes that Support Medical Necessity” section of the LCD, based on an external inquiry. The effective date of this revision is for claims processed on or after 06/30/2016, for dates of service on or after 10/01/15.
  • Revisions Due To ICD-10-CM Code Changes
04/11/2016 R3 Revision Number: 2
Publication: March 2016 Connection
LCR A/B 2016-045

Explanation of revision: This LCD was revised based upon data analysis displaying a high risk of improper claim payment. Utilization language was included in the “Utilization Guidelines” section of the LCD. The effective date of this revision is based on date of service.
  • Provider Education/Guidance
  • Public Education/Guidance
10/01/2015 R2 Revision Number: 1
Publication: January 2016 Connection
LCR A/B 2015-038

Explanation of revision: This LCD was revised to include ICD-10 codes M89.9 and M94.9 in the “ICD-10 Codes that Support Medical Necessity” section of the LCD. The effective date of this revision is for claims processed on or after 12/28/15, for dates of service on or after 10/01/15.
  • Revisions Due To ICD-10-CM Code Changes
10/01/2015 R1 The language and/or ICD-10-CM diagnoses were updated to be consistent with the current ICD-9-CM LCD’s language and coding.
  • Provider Education/Guidance
N/A

Associated Documents

Attachments
N/A
Related National Coverage Documents
N/A
Public Versions
Updated On Effective Dates Status
10/23/2020 10/29/2020 - N/A Currently in Effect You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

N/A

Read the LCD Disclaimer

Submit Feedback/Ask a Question