LCD L34914

Coverage Guidance

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for vitamins and metabolic function assay services. 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 vitamins and metabolic function assay services 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:

IOM Citations:

• CMS IOM Publication 100-02, Medicare Benefit Policy Manual,

• Chapter 6, Section 20.4 Outpatient Diagnostic Services

• Chapter 15, Section 80.1 Clinical Laboratory Services

• CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual,

• Chapter 1, Part 4, Section 230.19 Levocarnitine for use in the Treatment of Carnitine Deficiency in ESRD Patients

• CMS IOM Publication 100-04, Medicare Claims Processing Manual,

• Chapter 16, Laboratory Services

• Chapter 23, Section 10 Reporting ICD Diagnosis and Procedure codes and Section 40 Clinical Diagnostic Laboratory Fee Schedule

• 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.

Indications and Limitations of Coverage

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

Covered Indications

Medicare generally considers vitamin assay panels (more than one vitamin assay) a screening procedure and therefore, non-covered. Similarly, assays for micronutrient testing for nutritional deficiencies that include multiple tests for vitamins, minerals, antioxidants and various metabolic functions are never necessary. Medicare reimburses for covered clinical laboratory studies that are reasonable and necessary for the diagnosis or treatment of an illness. Many vitamin deficiency problems can be determined from a comprehensive history and physical examination. Any diagnostic evaluation should be targeted at the specific vitamin deficiency suspected and not a general screen. Most vitamin deficiencies are nutritional in origin and may be corrected with supplemented vitamins.

Most vitamin deficiencies are suggested by specific clinical findings. The presence of those specific clinical findings may prompt laboratory testing for evidence of a deficiency of that specific vitamin. Certain other clinical states may also lead to vitamin deficiencies (malabsorption syndromes, etc.).

Limitations:

For Medicare beneficiaries, screening tests are governed by statute. Vitamin or micronutrient testing may not be used for routine screening.

Once a beneficiary has been shown to be vitamin deficient, further testing is medically necessary only to ensure adequate replacement has been accomplished. Thereafter, annual testing may be appropriate depending upon the indication and other mitigating factors.

Notice: This LCD imposes the following limitations to the tests addressed in this LCD. Refer to the companion article Billing and Coding: Assays for Vitamins and Metabolic Function, A56416, for all coding information. These limitations will support automated denials as follows:

• Diagnosis to procedure limitations only for cellular function assays involving stimulation and detection of biomarker

• Frequency limitations** only for:

• Assay of ascorbic acid

• Assay of vitamin b-2

• Assay of vitamin b-1

• Assay of vitamin e

• Assay of vitamin a

• Assay of vitamin k

• Diagnosis to procedure and frequency limitations** for:

• Vitamin d 25 hydroxy

• Assay of carnitine

• Vitamin b-12

• Vitamin d 1 25-dihydroxy

• Assay of folic acid serum

• Assay of homocysteine

• Assay lipoprotein pla2

• Assay of vitamin b-6

• Fibrinogen antigen

**Note: This LCD imposes frequency limitations. Please refer to the Utilization Guidelines section for an outline of the frequency limitations. Frequency limitations do not establish medical necessity for all testing but does reflect how the medical community uses the tests. Patterns of billing will be monitored for potential utilization of these tests for screening purposes, either by use of a single test or multiple tests together.

Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.

The redetermination process may be utilized for consideration of services performed outside of the reasonable and necessary requirements in this LCD.

Summary of Evidence

N/A

Analysis of Evidence

N/A

Associated Information

Refer to the Local Coverage Article: Billing and Coding: Assays for Vitamins and Metabolic Function, A56416, for all coding information.

Documentation Requirements

• All documentation must be maintained in the patient’s medical record and made available to the contractor upon request.

• Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.

• The medical record documentation must support the medical necessity of the services as stated in this policy.

Utilization Guidelines

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

Medicare recognizes certain tests may exceed the stated frequencies. Should a denial occur, additional documentation can be submitted to support medical necessity. Payment for additional tests may be allowed in selected circumstances when, upon medical review, the medical necessity of additional services is demonstrated.

Following a review of utilization data at various percentiles of units billed per year, the following frequency limitations are established and are as follows:

Assay of ascorbic acid, 1 time per year

Vitamin d 25 hydroxyl, up to 3 times per year

Assay of carnitine, up to 3 times per year

Vitamin b-12, up to 3 times per year

Vitamin d 1 25-dihydroxy, up to 2 times per year

Assay of folic acid serum, up to 3 times per year

Assay of homocysteine, 1 time per year

Assay lipoprotein pla2, 1 time per year

Assay of vitamin b-6, 1 time per year

Assay of vitamin b-2, 1 time per year

Assay of vitamin b-1, 1 time per year

Assay of vitamin e, 1 time per year

Assay of vitamin a, 1 time per year

Assay of vitamin k, 1 time per year

Fibrinogen antigen, up to 3 times per year

Cell function assay w/stim frequencies not determined

Notice: This LCD imposes utilization guideline limitations. Despite Medicare's allowing up to these maximums, each patient’s condition and response to treatment must medically warrant the number of services reported for payment. Medicare requires the medical necessity for each service reported to be clearly demonstrated in the patient’s medical record. Medicare expects that patients will not routinely require the maximum allowable number of services.

Bibliography

• Albert MA, et al. The Effect of Statin Therapy on Lipoprotein Associated Phospholipase A2 Levels. Atherosclerosis 2005; 182: pp. 193–198.

• Anderson, JL. Lipoprotein-Associated Phospholipid A2: An Independent Predictor of Coronary Artery Disease Events in Primary and Secondary Prevention. Am J Cardiol 2008 Jun 16; 101(12A): 23F-33F.

• American College of Cardiology and American Heart Association, ACC/AHA 2002 Guideline Update for Management of Patients with Chronic Stable Angina, Circulation, 2003, 107: pp. 1–10.

• Centers for Medicare & Medicaid Services, Levocarnitine for Use in the Treatment of Carnitine Deficiency in ESRD Patients, Program Memorandum Transmittal AB-02-165, November 8, 2002.

• Colley KJ, Wolfert RL, Cobble ME. Lipoprotein associated phospholipase A2: role in atherosclerosis and utility as a biomarker for cardiovascular risk. EPMA J. 2011 Mar;2(1):27-38.

• Lp-PLA(2) Studies Collaboration, Thompson A, Gao P, et al. Lipoprotein-associated phospholipase A2 and risk of coronary disease, stroke, and mortality: collaborative analysis of 32 prospective studies. Lancet. 2010 May 1;375(9725):1536-44.

• Davidson MH, Corson MA, Alberts MJ, et al. Consensus Panel Recommendation For Incorporating Lipoprotein-Associated Phospholipase A2 Testing into Cardiovascular Disease Risk Assessment Guidelines. Am J Cardiol. 2008 Jun 16;101(12A):51F-57F.

• Epps KC, Wilensky RL. Lp-PLA2- a novel risk factor for high-risk coronary and carotid artery disease. J Intern Med. 2011 Jan;269(1):94-106.

• Federal Register, Vol. 66, No. 226, November 23, 2001, pp. 58788–58890.

• Hackam, DG, Anand SS. Emerging Risk Factors for Atherosclerotic Vascular Disease. JAMA, 2003, 290: pp. 932–940.

• Holick, MF et al. Evaluation, Treatment, and Prevention of Vitamin D Deficiency: An Endocrine Society Clinical Practice Guidelines. Journal of Clinical Endocrinology and Metabolism 2011 Jan; 96(7):1911-1930.

• Homocysteine Studies Collaboration. Homocysteine and Risk of Ischemic Heart Disease and Stroke: A Metaanalysis. JAMA 288 (16): pp. 2015–22, 2002.

• Hypophosphatasia. Review. https://ghr.nlm.nih.gov/condition/hypophosphatasia

• Jacobs DS, DeMott WR, Oxley DK. Jacobs and DeMott. Laboratory Test Handbook with Key Word Index, 5th Edition.

• Kelly JL et al. Vitamin D and Non-Hodgkin Lymphoma Risk in Adults: A Review. Clinical Invest. 2009 November; 27(9): 942-951.

• Kowalshi RJ, et al. Assessing Relative Risks of Infection and Rejection: A Meta-Analysis Using an Immune Function Assay (manuscript accepted for publication in Transplantation, April 25, 2006).

• Pasternak RC, Abrams J, Greenland P, et al. 34th Bethesda Conference: Task Force #1––Identification of Coronary Heart Disease Risk: Is There a Detection Gap? J Am Coll Cardiol. 2003 Jun 4;41(11):1863-74.

• Pitt B, Waters D, Brown WV, et al. Aggressive lipid-lowering therapy compared with angioplasty in stable coronary artery disease. Atorvastatin versus Revascularization Treatment Investigators. N Engl J Med. 1999 Jul 8;341(2):70-6.

• Tikkanen MJ, Szarek M, Fayyad R, et al. Total Cardiovascular Disease Burden: Comparing Intensive With Moderate Statin Therapy Insights From the IDEAL (Incremental Decrease in End Points Through Aggressive Lipid Lowering) Trial. J Am Coll Cardiol. 2009 Dec 15;54(25):2353-7.

• Timbie JW, Hayward RA, Vijan S. Variation in the Net Benefit Of Aggressive Cardiovascular Risk Factor Control Across the US Population Of Patients With Diabetes Mellitus. Arch Intern Med. 2010 Jun 28;170(12):1037-44.