Vitamin D Assay Testing (L31076)

Contractor Information

Contractor Name
Wisconsin Physicians Service Insurance Corporation		 Contractor Number
00951, 00952, 00953, 00954, 52280, 05101, 05201, 05301, 05401, 05102, 05202, 05302, 05402		 Contractor Type
Carrier - FI - MAC

LCD Information

Document Information
LCD ID Number
L31076

LCD Title
Vitamin D Assay Testing

Contractor's Determination Number
PATH-032

AMA CPT/ADA CDT Copyright Statement
CPT codes, descriptions and other data only are copyright 2011 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

Primary Geographic Jurisdiction


Oversight Region


Original Determination Effective Date
For services performed on or after 12/15/2010

Original Determination Ending Date


Revision Effective Date
For services performed on or after 04/01/2012

Revision Ending Date


CMS National Coverage Policy
Language quoted from Centers for Medicare and Medicaid Services (CMS). National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the Local Coverage Determination (LCD) Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See Section 1869(f)(1)(A)(i) of the Social Security Act. Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:

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

Medicare Benefit Policy Manual; Chapter 15 Covered Medical and Other Health Services
80.1 - Clinical Laboratory Services
(Rev. 79; Issued: 10-19-07; Effective: 01-01-03; Implementation: 11-19-07)
Section 1833 and 1861 of the 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. Laboratory services must meet all applicable requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA), as set forth at 42 CFR part 493. Section 1862(a)(1)(A) of the Act provides that Medicare payment may not be made for services that are not reasonable and necessary. Clinical laboratory services must be ordered and used promptly by the physician who is treating the beneficiary as described in 42 CFR 410.32(a), or by a qualified nonphysician practitioner, as described in 42 CFR 410.32(a)(3).
See section 80.6 of this manual for related physician ordering instructions.
See the Medicare Claims Processing Manual Chapter 16 for related claims processing instructions.

Medicare Claims Processing Manual; Chapter 16 - Laboratory Services

Indications and Limitations of Coverage 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, predominately from oily fish in the form of cholecalciferol, vitamin D3. Plant-based vitamin D is in the form of ergocalciferol, D2.It is really a hormone, as it is synthesized by the skin and metabolized by the liver and then, the kidney to an active hormone, calcitriol, which then acts in its classical action to absorb calcium from the intestine, and promote 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

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 it 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.


Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

011x Hospital Inpatient (Including Medicare Part A)
012x Hospital Inpatient (Medicare Part B only)
013x Hospital Outpatient
014x Hospital - Laboratory Services Provided to Non-patients
018x Hospital - Swing Beds
021x Skilled Nursing - Inpatient (Including Medicare Part A)
023x Skilled Nursing - Outpatient
071x Clinic - Rural Health
072x Clinic - Hospital Based or Independent Renal Dialysis Center
077x Clinic - Federally Qualified Health Center (FQHC)
083x Ambulatory Surgery Center
085x Critical Access Hospital

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

Revenue codes only apply to providers who bill these services to the fiscal intermediary or Part A MAC.

Revenue codes do not apply to physicians, other professionals and suppliers who bill these services to the
carrier or Part B MAC.

Please note that not all revenue codes apply to every type of bill code. Providers are encouraged to refer to the FISS revenue code file for allowable bill types. Similarly, not all revenue codes apply to each CPT/HCPCS code. Providers are encouraged to refer to the FISS HCPCS file for allowable revenue codes. All revenue codes billed on the inpatient claim for the dates of service in question may be subject to review.
0300 Laboratory - General Classification
0301 Laboratory - Chemistry
0309 Laboratory - Other Laboratory

CPT/HCPCS Codes
82306 VITAMIN D; 25 HYDROXY, INCLUDES FRACTION(S), IF PERFORMED
82652 VITAMIN D; 1, 25 DIHYDROXY, INCLUDES FRACTION(S), IF PERFORMED

ICD-9 Codes that Support Medical Necessity
Note: ICD-9 codes must be coded to the highest level of specificity

CPT code: 82306

Note: Use V58.65, to describe current long term use of glucocorticoids and V58.69 to describe long term use of anticonvulsants and other medication known to lower vitamin D levels.
010.00 - 018.96PRIMARY TUBERCULOUS COMPLEX UNSPECIFIED EXAMINATION - UNSPECIFIED MILIARY TUBERCULOSIS TUBERCLE BACILLI NOT FOUND BY BACTERIOLOGICAL OR HISTOLOGICAL EXAMINATION BUT TUBERCULOSIS CONFIRMED BY OTHER METHODS (INOCULATION OF ANIMALS)
135SARCOIDOSIS
252.00 - 252.9HYPERPARATHYROIDISM, UNSPECIFIED - UNSPECIFIED DISORDER OF PARATHYROID GLAND
268.0 - 268.9RICKETS ACTIVE - UNSPECIFIED VITAMIN D DEFICIENCY
275.3DISORDERS OF PHOSPHORUS METABOLISM
275.41HYPOCALCEMIA
275.42HYPERCALCEMIA
277.00 - 277.09CYSTIC FIBROSIS WITHOUT MECONIUM ILEUS - CYSTIC FIBROSIS WITH OTHER MANIFESTATIONS
278.4HYPERVITAMINOSIS D
278.8OTHER HYPERALIMENTATION
359.5MYOPATHY IN ENDOCRINE DISEASES CLASSIFIED ELSEWHERE
555.0 - 555.9REGIONAL ENTERITIS OF SMALL INTESTINE - REGIONAL ENTERITIS OF UNSPECIFIED SITE
556.0 - 556.9ULCERATIVE (CHRONIC) ENTEROCOLITIS - ULCERATIVE COLITIS UNSPECIFIED
571.2ALCOHOLIC CIRRHOSIS OF LIVER
571.5CIRRHOSIS OF LIVER WITHOUT ALCOHOL
571.6BILIARY CIRRHOSIS
571.8OTHER CHRONIC NONALCOHOLIC LIVER DISEASE
579.0 - 579.9CELIAC DISEASE - UNSPECIFIED INTESTINAL MALABSORPTION
585.3CHRONIC KIDNEY DISEASE, STAGE III (MODERATE)
585.4CHRONIC KIDNEY DISEASE, STAGE IV (SEVERE)
585.5CHRONIC KIDNEY DISEASE, STAGE V
585.6END STAGE RENAL DISEASE
588.81SECONDARY HYPERPARATHYROIDISM (OF RENAL ORIGIN)
649.20 - 649.24BARIATRIC SURGERY STATUS COMPLICATING PREGNANCY, CHILDBIRTH, OR THE PUERPERIUM, UNSPECIFIED AS TO EPISODE OF CARE OR NOT APPLICABLE - BARIATRIC SURGERY STATUS COMPLICATING PREGNANCY, CHILDBIRTH, OR THE PUERPERIUM, POSTPARTUM CONDITION OR COMPLICATION
696.1OTHER PSORIASIS AND SIMILAR DISORDERS
701.0CIRCUMSCRIBED SCLERODERMA
710.0SYSTEMIC LUPUS ERYTHEMATOSUS
710.3DERMATOMYOSITIS
729.1MYALGIA AND MYOSITIS UNSPECIFIED
731.0OSTEITIS DEFORMANS WITHOUT BONE TUMOR
733.00 - 733.09OSTEOPOROSIS UNSPECIFIED - OTHER OSTEOPOROSIS
733.90DISORDER OF BONE AND CARTILAGE UNSPECIFIED
756.51OSTEOGENESIS IMPERFECTA
756.52OSTEOPETROSIS
949.2 - 949.5BLISTERS WITH EPIDERMAL LOSS DUE TO BURN (SECOND DEGREE) UNSPECIFIED SITE - DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE UNSPECIFIED SITE WITH LOSS OF A BODY PART
V45.86BARIATRIC SURGERY STATUS
V58.65LONG-TERM (CURRENT) USE OF STEROIDS
V58.69LONG-TERM (CURRENT) USE OF OTHER MEDICATIONS

CPT code: 82652
010.00 - 018.96 PRIMARY TUBERCULOUS COMPLEX UNSPECIFIED EXAMINATION - UNSPECIFIED MILIARY TUBERCULOSIS TUBERCLE BACILLI NOT FOUND BY BACTERIOLOGICAL OR HISTOLOGICAL EXAMINATION BUT TUBERCULOSIS CONFIRMED BY OTHER METHODS (INOCULATION OF ANIMALS)
135 SARCOIDOSIS
200.30 - 200.38 MARGINAL ZONE LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES - MARGINAL ZONE LYMPHOMA, LYMPH NODES OF MULTIPLE SITES
202.10 - 202.28 MYCOSIS FUNGOIDES UNSPECIFIED SITE - SEZARY'S DISEASE INVOLVING LYMPH NODES OF MULTIPLE SITES
252.00 - 252.9 HYPERPARATHYROIDISM, UNSPECIFIED - UNSPECIFIED DISORDER OF PARATHYROID GLAND
268.0 RICKETS ACTIVE
278.8 OTHER HYPERALIMENTATION
585.3 CHRONIC KIDNEY DISEASE, STAGE III (MODERATE)
585.4 CHRONIC KIDNEY DISEASE, STAGE IV (SEVERE)
585.5 CHRONIC KIDNEY DISEASE, STAGE V
585.6 END STAGE RENAL DISEASE
588.81 SECONDARY HYPERPARATHYROIDISM (OF RENAL ORIGIN)
756.51 OSTEOGENESIS IMPERFECTA
756.52 OSTEOPETROSIS


Diagnoses that Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity

General Information

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

Appendices

Utilization Guidelines
In accordance with CMS Ruling 95-1 (V), 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 ICD 9-CM codes 268.0-268.9 will be limited to once a year.
4. Assays of the appropriate vitamin D levels for ICD-9 CM codes 268.0-268.9 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 it be repeated in another 3 months until the target level is achieved.)

Sources of Information and Basis for Decision
(WPS Medicare Services is not responsible for the continued viability of websites listed)

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Am. J. Kidney Dis.50(1):59-68(2007) "Changes in serum 25-hydroxyvitamin D and plasma intact PTH levels following treatment with ergocalciferol in patients with CKD", Al Aly, Z, et. al.
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The Journal of Clinical Endocrinology & Metabolism, Vitamin D Insufficiency and Hyperparathyroidism in a Low Income, Multiracial, Elderly Population
Tomida, K., et. al. "Serum 25-hydroxyvitamin D as an independent determinant of 1-84 PTH and bone mineral density in non-diabetic predialysis CKD patients", Bone, (2008)
Vieth R, Bischoff-Ferrari, H., Boucher B., et al.; The urgent need to recommend an intake of vitamin D that is effective; Am J of Clin Nutr; 2007; 85:649-650.
Välimäki, MJ, Tiihonen, M, Laitinen, K, et al. Bone mineral density measured by dual-energy X-ray absorptiometry and novel markers of bone formation and resorption in patients on antiepileptic drugs. J Bone Miner Res 1994; 9:631.
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Other Contractor policies including NGS and Highmark

Advisory Committee Meeting Notes
Meeting Date:
Wisconsin 06/18/2010
Illinois 05/19/2010
Michigan 05/12/2010
Minnesota 05/06/2010
J5: Iowa, Kansas, Missouri, Nebraska 06/24/2010
Date of the Open Meeting: 04/22/2010



This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the MAC contractor this policy was developed in cooperation with advisory groups which include representatives from various specialties, and adapted for the purpose of converting to MAC jurisdiction.

Start Date of Comment Period
06/24/2010
End Date of Comment Period
08/08/2010
Start Date of Notice Period
04/01/2011

Revision History Number
X
Revision History Explanation
11/21/2010 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:
82306 descriptor was changed in Group 1
82652 descriptor was changed in Group 1

02/21/2011 - In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of Delaware, District of Columbia, Maryland, New Jersey and Pennsylvania were removed from this LCD because claims processing for these states are transitioning from FI Wisconsin Physician Service (WPS 52280) to MAC Part A contractor Highmark (12901).

04/01/2011 Removed requirement that ICD-9 code 268.2 be added when codes V58.65 or V58.69 are billed.

04/01/2012 Corrected an omission and added code 278.4 to the policy.

Reason for Change
ICD9 Addition/Deletion

Related Documents
This LCD has no Related Documents.

LCD Attachments

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Page Last Updated: Tuesday, 03-Apr-2012 08:27:22 CDT