BlueCross and BlueShield of Montana Medical Policy/Codes
Lymphocyte Transformation Test
Chapter: Medicine: Tests
Current Effective Date: October 25, 2013
Original Effective Date: October 25, 2013
Publish Date: July 25, 2013
Revised Dates: This medical document is no longer scheduled for routine literature review and update.
Description

Lymphocyte proliferation normally occurs early in an immune response.  Lymphocyte transportation assays test the integrity of the early proliferative response using either nonspecific mitogens or specific antigens to induce blastogenesis.  Antigen induced lymphocyte proliferation also correlates with previous exposure and acquisition of cellular immunity.

Lymphocyte transformation tests evaluate lymphocyte competence using in vitro tests to assess the ability of the lymphocytes to proliferate and to recognize and respond to antigens.  Two types of lymphocyte transformation tests, mitogens assay and antigen assay are discussed in this policy.

The mitogen assay, performed using nonspecific plant lectins, evaluates the mitotic response of T and B lymphocytes to a foreign antigen.  In the mitogen assay, a purified culture of lymphocytes from the patient’s blood is incubated with a nonspecific mitogen for 72 hours.  The culture is then pulse-labeled with tritiated thymidine and can be measured by a liquid scintillation spectrophotometer in counts per minute, which parallels the rate of mitosis.  Lymphocyte responsiveness or the extent of mitosis is then reported as a stimulation index, determined by dividing the counts per minute of the stimulated culture by the counts per minute of a control culture.

The antigen assay uses specific antigens, such as purified protein derivative (PPD), Candida, mumps, tetanus toxoid and streptokinase, to stimulate lymphocyte transformation.  After incubation of 4 ½ to 7 days, transformation is measured by the same method used in the mitogen assay.

In the mitogen and antigen assays, a low stimulation index or unresponsiveness indicates a suppressed or defective immune system.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions.  Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Medically Necessary

Blue Cross and Blue Shield of Montana (BCBSMT) may consider the lymphocyte transformation test (i.e., Lymphocyte Mitogen Response test or the PHE Stimulation test) medically necessary for the following:

  • Diagnosis and management of:
  1. Chronic mucocutaneous candidiasis; OR
  2. Congenital or acquired immunodeficiency disorders; OR
  3. Severe combined immune deficiency; OR
  4. DiGeorge anomaly; OR
  5. Nezelof syndrome; OR
  • As an aid in the following applications:
  1. Studying the integrity of lymphokine production; OR
  2. Monitoring immunosuppressive or immunoenhancing therapy; OR
  3. Predicting allograft compatibility in the transplantation setting.

In addition, it is expected that the results of this test will be used in the management of the patient.

Not Medically Necessary

BCBSMT considers the lymphocyte transformation test for indications other than those listed above not medically necessary.

The lymphocyte transformation test is considered not medically necessary as a screening test.

Rationale

Lymphocyte transformation tests are used for many reasons.  Some uses are considered not medically necessary, such as its use as a screening test and to monitor cancer, occupational exposure to dust and other antigens, and other environmental antigens and mitogens.  This policy addresses the situations where the use of this test would be considered appropriate.

2007 Update

A search of the literature was completed through MedLine database for the period of January 2000 through March 2007.  No additional published studies were identified that would prompt reconsideration of the policy statement, which remains unchanged.  The use of the lymphocyte transformation has not been proven to improve outcomes when used as a screening tool.

2009 Update

A search of peer-reviewed literature through August 2009 identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.

2012 Update

A search of peer reviewed literature through February 2012 identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.

Coding

Disclaimer for coding information on Medical Policies           

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy.  They may not be all-inclusive.           

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers.  Only the written coverage position in a medical policy should be used for such determinations.           

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

Refer to the ICD-9-CM manual.

ICD-10 Codes

Refer to the ICD-10-CM manual.

Procedural Codes: 86353
References
  1. Jacobs, J.S., Demott, W.R., et al.  Laboratory Test Handbook, Lymphocyte Transformation Test.  (1996):416-7.
  2. National Jewish Medical & Research Center Cellular Immunology Tests; Lymphocyte Function Assays; http://www.njc.org .
  3. Kaluza, W., Meyer zum Buschenfelde, K.H., et al.  Synovial fluid lymphocyte proliferation in response to crude microbial antigens is not useful as a diagnostic test to specifically indicate a bacterial cause of arthritis.  Clinical and Experimental Rheumatology (2000 January – February) 18(1): 9-46.
  4. Jacobs, J.S., Demott, W.R., Oxley, D.K., eds.  Lymphocyte Transformation Test.  Laboratory Test Handbook (2001):539-40.
  5. Medicare Part B/CMS Region II, New York, Lymphocyte Transformation; July 1, 2002.
  6. Pichler, W.J., and J. Tilch.  The lymphocyte transformation test in the diagnosis of drug hypersensitivity.  Allergy (2004 August) 59(8):809-20.
  7. Hagemann, T., Schlutter-Bohmer, B., et al.  Positive lymphocyte transformation test in a patient with allergic contact dermatitis of the scalp after short-term use of topical minoxidil solution.  Contact Dermatitis (2005 July) 53(1):53-5.
  8. Valentine-Thon, E., Ilsemann, K., et al.  A novel lymphocyte transformation test [LTT-MELISA (R)] for Lyme borreliosis.  Diagnostic Microbiology and Infectious Disease (2007 January) 57(1):27-34.
  9. CMS - National Coverage Determination (NCD) for Lymphocyte Mitogen Response Assays (190.8) (1983 May 16).  Available at www.cms.gov (accessed 2012 February 22).
  10. Mayo Clinic, Mayo Medical Laboratories.  Lymphocyte Proliferation Panel for Mitogens and Antigens (2012).  Available at www.mayomedicallaboratories (accessed 2012 March 8).
History
July 2013  New 2013 BCBSMT medical policy.
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Lymphocyte Transformation Test