Nonstandard Laboratory Test Panels
Number: 0499
Table Of Contents
PolicyApplicable CPT / HCPCS / ICD-10 Codes
Background
References
Policy
Scope of Policy
This Clinical Policy Bulletin addresses nonstandard laboratory test panels.
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Experimental, Investigational, or Unproven
Aetna considers laboratory test panels experimental, investigational, or unproven if they include nonstandard tests that have no proven value. Laboratory test panels may also be considered experimental, investigational, or unproven if they include standard tests that are performed for persons without specific signs and symptoms warranting performance of the test and for indications that are not established.
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Aeron Life Cycles
Aetna considers the following test panels from Aeron Life Cycles experimental, investigational, or unproven because of insufficient evidence:
- BPAssay
- Saliva Analysis
- Urine Bone Marker.
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Alletess Medical Laboratory
Aetna considers the following tests from Alletess Medical Laboratory experimental, investigational, or unproven because of insufficient evidence:
- Hytex Enzyme Immunoassay
- Food Sensitivity Testing Panel
- Vegetarian 80 IgG Food Pane
- Pediatric 80 IgG Food Panel
- Gastrointestinal Panel
- Protein Sensitivity Panel
- Casein/Gluten Screen
- Candida Immune Complex
- Candida Profile
- Microflora Immune Competency Test
- Comprehensive 96 IgG Immune Panel
- Comprehensive 184 IgG Immune Panel.
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BioHealth
Aetna considers the following BioHealth Test Panels experimental, investigational, or unproven because of insufficient evidence:
- Functional Adrenal Stress Profiles, Saliva
- Female Hormone Profiles, Saliva
- Melatonin Biorhythm Profile, Saliva
- DHEA-s Average. Saliva
- Expanded Circadian Rhythm, Saliva
- Metabolic Assessment Profile, Urine
- GI Pathology Screen, Stool
- Intestinal Barrier Function Screen, Salivary
- Celiac/Gluten Sensitive Enteropathy Profile, Blood/Saliva
- Expanded Chemistry Profile, Blood
- Coronary Risk Screen
- Glycemic Control Screen.
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DiagnosTechs
Aetna considers the following DiagnosTechs Laboratory Test Panels experimental, investigational, or unproven because of insufficient evidence of their clinical value:
- Adrenal Stress Index
- Bone Health Panel
- Female Hormone Panel
- Food Intolerance Panel
- Gastrointestinal Health Panel
- Male Hormone Panel
- Postmenopause and Perimenopause Panels.
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Doctor's Data Lab
Aetna considers the following Doctor's Data Lab Panels experimental, investigational, or unproven unless otherwise noted, because of insufficient evidence of their clinical value:
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Nutritional
- Fatty Acids; Erythrocytes
- Plasma Amino AcidsFootnote1*
- Urine Amino AcidsFootnote1*
- Urine FluorideFootnote2**
- Urine Halides
- Urine Halides; Pre and Post Loading
- Urine Iodine
- Urine Iodine; Pre and Post LoadingFootnote3***
Notes:
Footnote1* Plasma and urinary amino acids may be medically necessary for screening neonates and for testing other persons with signs and symptoms of primary or secondary aminoacidopathies.
Footnote2** Urine fluorides may be medically necessary for persons with signs and symptoms of fluoride toxicity.
Footnote3*** Urine iodine may be medically necessary for persons with signs and symptoms of iodine deficiency.
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Clinical Microbiology
- Bacteriology Culture, Stool
- Comprehensive Clostridium Culture, Stool
- Comprehensive Parasitology x1, Stool
- Comprehensive Parasitology x2, Stool
- Comprehensive Parasitology x3, Stool
- Comprehensive Stool Analysis
- Comprehensive Stool Analysis w/Parasitology x1
- Comprehensive Stool Analysis w/Parasitology x2
- Comprehensive Stool Analysis w/Parasitology x3
- Comprehensive Vaginosis Profile
- Intestinal Permeability
- Lysozyme Stool
- Microbiology Profile, Stool
- Parasitology x1, Stool
- Parasitology x2, Stool
- Parasitology x3, Stool
- Secretory lgA, stool
- Stool Chemistry
- Stool Yeast Culture
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Toxic and Essential Elements
- Comprehensive Blood Elements
- Fecal Metals
- Hair Elements
- Hair Toxic Element Exposure Profile
- Red Blood Cell (RBC) Elements
- Urine Toxic & Essential Elements
- Urine Toxic Metals
- Whole Blood Chromium & Vanadium
- Whole Blood Elements
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Drinking Water Analysis
- Comprehensive Drinking Water Analysis
- Drinking Water Analysis
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Bloodspot
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DNA Methylation Pathway, Bloodspot.
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Cardiovascular
- Cardiovascular Risk Profile
- Comprehensive Cardiovascular Profile
- Oxidized LDL
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Environmental Exposure/Detoxification
- DNA Methylation Pathway; Whole Blood
- DNA Oxidative Damage Assay
- Glutathione, ErythrocytesFootnote4†
- Hepatic Detox Profile
- Methylation Profile, Plasma
- Urine PorphyrinsFootnote5††
Notes:
Footnote4† Red cell glutathione is considered medically necessary for persons with hemolytic anemia and for persons with signs and symptoms of defects of red blood cell metabolsim.
Footnote5†† Measurement of urine porphyrins is considered medically necessary for persons with signs and symptoms of porphyria.
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Great Plains Laboratory
Aetna considers the following Great Plains Laboratory Test panels experimental, investigational, or unproven because there is insufficient published peer-reviewed evidence of their clinical utility:
- Basic Autism Panel
- Comprehensive Autism Panel
- Basic Tourette's Tics Panel
- Comprehensive Tourette's Tics Panel
- Basic Wellness Panel
- Comprehensive Wellness Panel
- Basic Fibromyalgia and CFS Panel
- Comprehensive Fibromyalgia and CFS Panel
- Basic Mental Health Panel
- Comprehensive Mental Health Panel.
The following Great Plains Laboratory Tests and Panels are considered experimental, investigational, or unproven:
- Advanced Cholesterol Profile
- Amino Acids Plasma Test
- Amino Acids Urine Test
- Comprehensive Fatty Acids Test
- Comprehensive Stool Analysis
- Copper / Zinc Profile
- Full Organic Acids Test (OAT)
- Gluten / Casein Peptides Test
- GPL-TOX Profile (for toxic non-metal chemicals)
- Hormone Panels
- IgG Food Allergy Test with Candida
- Immune Deficiency Profile
- Kryptopyrrole Test
- Metals Fecal Test
- Metals Hair Test
- Metals Red Blood Cell Test
- Metals Urine Test
- Metals Whole Blood Test
- Microbial Organic Acids Test (MOAT)
- MOAT Plus Yeast Culture with Sensitivity Combo
- OAT Plus Amino Acids Urine Test Combo
- OAT Plus IgG Food Allergy Test with Candida Combo
- OAT Plus Yeast Culture with Sensitivity Combo
- Organic Acids Test
- Porphyrins ProfileFootnote6†††
- Streptococcus Antibodies Profile
- Yeast Culture and Sensitivity Test, Stool.
Footnote6††† Measurement of urine porphyrins is considered medically necessary for persons with signs and symptoms of porphyria.
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Moleculera Labs
The following test panel from Moleculera Labs is considered experimental, investigational, or unproven:
- Pediatric autoimmune neuropsyciatric disorders associated with group A streptococci (PANDAS)
- Cunningham Test Panel.
- Pediatric autoimmune neuropsyciatric disorders associated with group A streptococci (PANDAS)
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Physicians Lab
Physicians Lab urine panels are considered experimental, investigational, or unproven, including:
- Comprehensive #1 24-hour urine profile
- Comprehensive #2 24-hour urine profile
- Estrogen specific 24-hour urine profile
- Androgen specific 24-hour urine profile
- Cortisol specific 24-hour urine profile
- First morning void profile.
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ZRT Laboratory
The following test panels from ZRT Laboratory are considered experimental, investigational, or unproven because of insufficient published, peer-reviewed evidence:
- Weight Management Profile, Blood Spot/Saliva
- Fertility Profile, Blood Spot/Saliva
- Dried Urine Metabolites
- Complete Urine Metabolites
- Urine Sex Steroid Metabolites
- Urinary Free Cortisols.
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Other Laboratories
The following laboratories perform non-standard test panels that are considered experimental, investigational, or unproven; most also perform various standard tests:
- Age Diagnostic Laboratories
- Bio-Center Laboratory (BCL)
- BioLab Medical Unit
- Center for Complex Medical Systems
- Dried Urine Test for Comprehensive Hormones (DUTCH) testing
- Fry Laboratories, LLC
- Genelex Corp.
- Immuno Laboratories
- Immunosciences Lab, Inc.
- IntraCellular Diagnostics, Inc.
- Iverson Genetic Diagnosis
- King James Lab
- LabInterpretation LLC
- Labrix Clinical Services
- Meridian Valley Lab
- Metametrix Clinical Laboratory
- Molecular Testing Labs (Blackfly Investments, LLC)
- NutriChem Biomedical Testing Laboratory
- PathoGenius Laboratory
- PersonalizedDx Labs
- Pharmasan Labs
- Primex Clinical Laboratories
- RealTime Laboratories, Inc.
- Salveo Diagnostics Advanced Blood/Stool Testing Profiles/Panels
- SpectraCell Laboratories, Inc.
- Trace Minerals International Laboratory
- U.S. BioTek
- YorkTest Laboratories.
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Related Policies
- CPB 0140 - Genetic Testing
- CPB 0177 - Helicobacter Pylori Infection Testing
- CPB 0215 - Lyme Disease and other Tick-Borne Diseases
- CPB 0249 - Inflammatory Bowel Disease: Serologic Markers and Pharmacogenomic and Metabolic Assessment of Thiopurine Therapy
- CPB 0396 - Gastrointestinal Function: Selected Tests
- CPB 0438 - Obsolete and Unreliable Tests and Procedures
- CPB 0561 - Celiac Disease Laboratory Testing
- CPB 0650 - Polymerase Chain Reaction Testing: Selected Indications
- CPB 0608 - Salivary Tests
- CPB 0691 - Exhaled Breath Tests
- CPB 0715 - Pharmacogenetic and Pharmacodynamic Testing
- CPB 1008 - Metagenomic Next Generation Sequencing Tests for Infectious Diseases
Background
Functional medicine is the discipline of healthcare that utilizes laboratory assessment and early intervention to improve physiological, emotional/cognitive, and physical function. This approach focuses attention on biochemical individuality, metabolic balance, ecological context and unique personal experience in the dynamics of health. Evaluating organ "function" versus organ "pathology" is one of the principles of functional medicine. Some manufacturers have developed many laboratory assessment test panels that purportedly allow physicians to understand a patient's functional status. Using stool, urine, saliva, blood, and hair samples, test panels focus on the functional “status” of the body in 6 areas:
- digestion (gastrointestinal),
- nutrition,
- detoxification/oxidative stress,
- immunology/allergy,
- production and regulation of hormones (endocrinology), and/or
- heart and blood vessels (cardiovascular).
Some manufacturers claim to uncover the root causes of symptoms, allowing the physician to recommend intervention strategies that will solve the chronic problem. Many of these tests employ special substances and protocols to "challenge" organs, supposedly giving the physician an opportunity to evaluate the function of an organ system while it is stressed, thereby providing information that often is missed using conventional laboratory testing. These test panels have been advocated to be of use in the management of patients with various diseases/conditions such as AIDS, Alzheimer’s disease, attention deficit/hyperactivity disorder, autism, cardiovascular diseases, chronic fatigue syndrome, cystic fibrosis, depression and mood disorders, headaches, inflammatory bowel disease, insomnia and sleep disorders, male infertility, memory loss and dementia, multiple sclerosis, obesity, osteoarthritis, osteoporosis, premenstrual syndrome, rheumatoid arthritis, sexual dysfunction, and skin disorders.
However, there is no evidence that these laboratory test panels affect the management of afflicted individuals.
PANDAS
A diagnosis of PANDAS is made with prospective evaluation, including documentation, of an episode of neuropsychiatric symptoms associated with evidence of group A streptococcal infection. Diagnostic criteria include obsessive-compulsive disorder and/or tic disorder with a pediatric onset between three years and onset of puberty, abrupt onset and episodic course of symptoms, neurologic abnormalities as well as a temporal relationship between the onset and/or exacerbation of symptoms and a confirmed group A streptococcal infection (Pichichero, 2022). A review by Macerollo et al (2013) stated that “[o]verall, the available evidence does not convincingly support the concept that PANDAS ae a well-defined isolated clinical entity subdued by definite pathophysiological mechanisms.” The Cunningham Test Panel consists of a series of 5 clinical assays, including the enzyme-linked immunosorbent assays lysogangioside, tubulin, dopamine receptor D1, and dopamine receptor D2 as well as a measure of the level of activity of canclium/calmodulin-dependent protein kinase. Large scale prospectively designed studies are needed to establish an evidence base in support of the Cunningham Test Panel for PANDAS.
References
The above policy is based on the following references:
- Agency for Healthcare Policy and Research (AHCPR), Depression Guideline Panel. Depression in primary care. Volume 1. Detection and diagnosis. AHCPR Clinical Practice Guideline No. 5. AHCPR Pub. No. 93-0550. Rockville, MD: AHCPR; April 1993.
- Agency for Healthcare Policy and Research (AHCPR). Recognition and initial assessment of Alzheimer’s disease and related dementias. Clinical Practice Guideline No. 19. AHCPR Publication No. 97-0702. Rockville, MD: AHCPR; November 1996.
- Agency for Healthcare Policy and Research (AHCPR). Systematic review of the literature regarding the diagnosis of sleep apnea. Evidence Report/Technology Assessment No. 1. AHCPR Publication No. 99-E002. Rockville, MD: AHCPR; December 1998.
- American Academy of Allergy, Asthma and Immunology (AAAAI) Board of Directors. Idiopathic environmental intolerances. J Allergy Clin Immunol. 1999;103(1 Pt 1):36-40.
- American Academy of Neurology. Practice parameters for the diagnosis and evaluation of dementia (summary statement). Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 1994;44(11):2203-2206.
- American Academy of Pediatrics. Clinical practice guideline: Diagnosis and evaluation of the child with attention-deficit/hyperactivity disorder. Pediatrics. 2000;105(5):1158-1170.
- American College of Gastroenterology Task Force on Irritable Bowel Syndrome, Brandt LJ, Chey WD, Foxx-Orenstein AE, et al. An evidence-based position statement on the management of irritable bowel syndrome. Am J Gastroenterol. 2009;104 Suppl 1:S1-S35.
- American College of Rheumatology Ad Hoc Committee on Clinical Guidelines. Guidelines for the management of rheumatoid arthritis. Arthritis Rheum. 1996;39(5):713-722.
- Ang DC, Calabrese LH. A common-sense approach to chronic fatigue in primary care. Cleve Clin J Med. 1999;66(6):343-350, 352..
- Blocker WP Jr, Ostermann HJ. Obesity: Evaluation and treatment. Dis Mon. 1996;42(12):829-873.
- Bratten JR, Spanier J, Jones MP. Lactulose breath testing does not discriminate patients with irritable bowel syndrome from healthy controls. Am J Gastroenterol. 2008;103(4):958‐963.
- Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Diagnostic Breath Analyses (100.5). Baltimore, MD: CMS; effective June 12, 1984.
- Dulcan M. Practice parameters for the assessment and treatment of children, adolescents, and adults with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 1997;36(10 Suppl):85S-121S.
- Griffin JW, Hsieh ST, McArthur JC, Cornblath DR. Laboratory testing in peripheral nerve disease. Neurol Clin. 1996;14(1):119-133.
- Hoffenberg EJ. Serologic testing for inflammatory bowel disease. J Pediatr. 1999;134(4):447-452.
- Macerello A, Martino D. Pediatric autoimmune neuropsyciatric disorders associated with group A streptococci (PANDAS): An evolving concept. Tremor Other Hyperkinet Mov (N Y). 2013; 3: tre-03-167-4158-7.
- McNicholas WT. Clinical diagnosis and assessment of obstructive sleep apnoea syndrome. Monaldi Arch Chest Dis. 1997;52(1):37-42.
- Mersch PP, Middendorp HM, Bouhuys AL, et al. Seasonal affective disorder and latitude: A review of the literature. J. Affect Disord. 1999;53(1):35-48.
- Moleculera Labs. Insurance reimbursement FAQs for the Cunningham panel of tests [website]. Oklahoma City, OK: Moleculera Labs; 2015. Available at: http://www.moleculera.com/wp-content/uploads/2014/06/Insurance-Reimbursement-FAQs-2.pdf. Accessed May 21, 2015.
- Pichichero M. PANDAS: Pediatric autoimmune neuropsychiatric disorder associated with group A streptococci. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed April 25, 2022.
- The Interagency Workgroup on Multiple Chemical Sensitivity. A Report on Multiple Chemical Sensitivity. Atlanta, GA: Agency for Toxic Substances and Disease Registry; August 24, 1998:45.
- The Process of Care Consensus Panel. The process of care model for evaluation and treatment of erectile dysfunction. Int J Impot Res. 1999;11(2):59-74.
