Nonstandard Laboratory Test Panels

Number: 0499

Table Of Contents

Policy
Applicable CPT / HCPCS / ICD-10 Codes
Background
References


Policy

Scope of Policy

This Clinical Policy Bulletin addresses nonstandard laboratory test panels.

  1. 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.

    1. 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.
    2. 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.
    3. 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.
    4. 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.
    5. 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:

      1. 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.

      2. 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
      3. 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
      4. Drinking Water Analysis
        • Comprehensive Drinking Water Analysis
        • Drinking Water Analysis
      5. Bloodspot
        • DNA Methylation Pathway, Bloodspot.

      6. Cardiovascular
        • Cardiovascular Risk Profile
        • Comprehensive Cardiovascular Profile
        • Oxidized LDL
      7. 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.

    6. 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.

    7. 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.
    8. 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.
    9. 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.
    10. 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.
  2. Related Policies


Table:

CPT Codes / HCPCS Codes / ICD-10 Codes

Code Code Description

Great Plains Laboratory:

Other CPT codes related to the CPB:

80299 Quantitation of therapeutic drug, not elsewhere specified
82108 Aluminum
82131 Amino acids; single, quantitative, each specimen
82139 Amino acids, 6 or more amino acids, quantitative, each specimen
82140 Ammonia
82172 Apolipoprotein, each
82175 Arsenic
82272 Blood, occult, by peroxidase activity (eg, guaiac), qualitative, feces, 1-3 simultaneous determinations, performed for other than colorectal neoplasm screening
82300 Cadmium
82306 Vitamin D; 25 hydroxy, includes fraction(s), if performed
82310 Calcium; total
82390 Ceruloplasmin
82465 Cholesterol, serum or whole blood, total
82495 Chromium
82507 Citrate
82525 Copper
82530 Cortisol; free
82542 Column chromatography, includes mass spectrometry, if performed (eg, HPLC, LC, LC/MS, LC/MS-MS, GC, GC/MS-MS, GC/MS, HPLC/MS), non-drug analyte(s) not elsewhere specified, qualitative or quantitative, each specimen
82570 Creatinine; other source
82626 Dehydroepiandrosterone (DHEA)
82656 Elastase, pancreatic (EL-1), fecal, qualitative or semi-quantitative
82670 Estradiol
82677 Estriol
82679 Estrone
82728 Ferritin
82784 Gammaglobulin (immunoglobulin); IgA, IgD, IgG, IgM, each
82785 Gammaglobulin; IgE
82787 Gammaglobulin (immunoglobulin); immunoglobulin subclasses (eg, IgG1, 2, 3, or 4), each
83015 Heavy metal (eg, arsenic, barium, beryllium, bismuth, antimony, mercury)
83018 Heavy metal (eg, arsenic, barium, beryllium, bismuth, antimony, mercury); quantitative, each
83090 Homocysteine
83150 Homovanillic acid (HVA)
83497 Hydroxyindolacetic acid, 5-(HIAA)
83516 Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or semiquantitative, multiple step method
83519 Immunoassay, analyte, quantitative; by radiopharmaceutical technique (e.g., RIA)
83605 Lactate (lactic acid)
83631 Lactoferrin, fecal; quantitative
83655 Lead
83695 Lipoprotein (a)
83718 Lipoprotein, direct measurement; high density cholesterol (HDL cholesterol)
83735 Magnesium
83785 Manganese
83825 Mercury, quantitative
83883 Nephelometry, each analyte not elsewhere specified
83885 Nickel
83921 Organic acids, single, quantitative
83945 Oxalate
83986 pH; body fluid, not otherwise specified
84100 Phosphorus inorganic (phosphate)
84120 Porphyrins, urine; quantitation and fractionation
84255 Selenium
84285 Silica
84295 Sodium; serum, plasma or whole blood
84402 Testosterone; free
84540 Urea nitrogen, urine
84585 Vanillylmandelic acid (VMA), urine
84591 Vitamin, not otherwise specified
84630 Zinc
84999 Unlisted chemistry procedure
85549 Muramidase
85999 Unlisted hematology and coagulation procedure
86001 Allergen specific IgG quantitative or semiquantitative, each allergen
86141 C-reactive protein; high sensitivity (hsCRP)
86215 Deoxyribonuclease, antibody
86628 Antibody; Candida
86671 Antibody; fungus, not elsewhere specified
87045 Culture, bacterial; stool, aerobic, with isolation and preliminary examination (eg, KIA, LIA), Salmonella and Shigella species
87046     stool, aerobic, additional pathogens, isolation and presumptive identification of isolates, each plate
87102 Culture, fungi (mold or yeast) isolation, with presumptive identification of isolates; other source (except blood)
87106 Culture, fungi, definitive identification, each organism; yeast
87177 Ova and parasites, direct smears, concentration and identification
87184 Susceptibility studies, antimicrobial agent; disk method, per plate (12 or fewer agents)
87209 Smear, primary source with interpretation; complex special stain (eg, trichrome, iron hemotoxylin) for ova and parasites
87220 Tissue examination by KOH slide of samples from skin, hair, or nails for fungi or ectoparasite ova or mites (e.g., scabies)
87328 Infectious agent antigen detection by enzyme immunoassay technique, qualitative or semiquantitative, multiple-step method; cryptosporidium
87329     giardia
87999 Unlisted microbiology procedure
88199 Unlisted cytopathology procedure
88299 Unlisted cytogenetic study
88399 Unlisted surgical pathology procedure
89125 Fat stains, feces, urine, or respiratory secretions
89160 Meat fibers, feces

Test and panels that have no specific code(s):

Kryptopyrrole Test, Great Plains Laboratory’s GPL-TOX Profile (toxic non-metal chemicals)

BioHealth:

Other CPT codes related to the CPB:

80053 Comprehensive metabolic panel
80061 Lipid panel
80299 Quantitation of therapeutic drug, not elsewhere specified
82150 Amylase
82172 Apolipoprotein, each
82270 Blood, occult, by peroxidase activity (eg, guaiac), qualitative; feces, consecutive collected specimens with single determination, for colorectal neoplasm screening (ie, patient was provided three cards or single triple card for consecutive collection)
82274 Blood, occult, by fecal hemoglobin determination by immunoassay, qualitative, feces, 1-3 simultaneous determinations
82330 Calcium; ionized
82530 Cortisol; free
82533 Cortisol; total
82550 Creatine kinase (CK), (CPK); total
82607 Cyanocobalamin (Vitamin B-12)
82627 Dehydroepiandrosterone-sulfate (DHEA-S)
82670 Estradiol
82677 Estriol
82679 Estrone
82728 Ferritin
82746 Folic acid; serum
82784 Gammaglobulin (immunoglobulin); IgA, IgD, IgG, IgM, each
83090 Homocysteine
83516 Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or semiquantitative, multiple step method
83519 Immunoassay, analyte, quantitative; by radiopharmaceutical technique (e.g., RIA)
83527 Insulin; free
83540 Iron
83550 Iron binding capacity
83615 Lactate dehydrogenase (LD), (LDH)
83735 Magnesium
84100 Phosphorus inorganic (phosphate)
84144 Progesterone
84311 Spectrophotometry, analyte not elsewhere specified
84392 Sulfate, urine
84403 Testosterone; total
84436 Thyroxine; total
84439 Thyroxine; free
84443 Thyroid stimulating hormone (TSH)
84466 Transferrin
84481 Triiodothyronine T3; free
84550 Uric acid; blood
84999 Unlisted chemistry procedure
85018 Blood count; hemoglobin (Hgb)
85025 Blood count; complete (CBC), automated (Hgb, Hct, RBC, WBC and platelet count) and automated differential WBC count
85999 Unlisted hematology and coagulation procedure
86141 C-reactive protein; high sensitivity (hsCRP)
86256 Fluorescent noninfectious agent antibody; titer, each antibody
86430 Rheumatoid factor; qualitative
86628 Antibody; Candida
87081 Culture, presumptive, pathogenic organisms, screening only
87101 Culture, fungi (mold or yeast) isolation, with presumptive identification of isolates; skin, hair, or nail
87106 Culture, fungi, definitive identification, each organism; yeast
87177 Ova and parasites, direct smears, concentration and identification
87324 Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; Clostridium difficile toxin(s)
87328 Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; cryptosporidium
87329     giardia
87337     entamoeba histolytica group
87338     helicobacter pylori, stool
87999 Unlisted microbiology procedure
88199 Unlisted cytopathology procedure
88299 Unlisted cytogenetic study
88399 Unlisted surgical pathology procedure

Test and panels that have no specific code(s):

DHEA-s Average, Expanded Circadian Rhythm

DiagnosTechs:

Other CPT codes related to the CPB:

80299 Quantitation of therapeutic drug, not elsewhere specified
84999 Unlisted chemistry procedure
85999 Unlisted hematology and coagulation procedure
87999 Unlisted microbiology procedure
88199 Unlisted cytopathology procedure
88299 Unlisted cytogenetic study
88399 Unlisted surgical pathology procedure

Test and panels that have no specific code(s):

Adrenal Stress Index, Bone Health Panel, Female Hormone Panel, Food Intolerance Panel, Gastrointestinal Health Panel, Male Hormone Panel, Postmenopause and Perimenopause Panels

Doctor's Data Lab:

Other CPT codes related to the CPB:

80299 Quantitation of therapeutic drug, not elsewhere specified
84999 Unlisted chemistry procedure
85999 Unlisted hematology and coagulation procedure
87999 Unlisted microbiology procedure
88199 Unlisted cytopathology procedure
88299 Unlisted cytogenetic study
88399 Unlisted surgical pathology procedure

Test and panels that have no specific code(s):

Bacteriology Culture, Comprehensive Clostridium Culture, Comprehensive Parasitology, Comprehensive Stool Analysis, Comprehensive Stool Analysis w/Parasitology,Comprehensive Vaginosis Profile, Intestinal Permeability, Lysozyme Stool, Microbiology Profile, Parasitology, Secretory lgA, Stool Chemistry, Stool Yeast Culture, 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, Comprehensive Drinking Water Analysis, Drinking Water Analysis, DNA Methylation Pathway, Cardiovascular Risk Profile, Comprehensive Cardiovascular Profile, Oxidized LDL, DNA Oxidative Damage Assay, Glutathione, Erythrocytes, Hepatic Detox Profile, Methylation Profile, Urine Porphyrins

ZRT Laboratory:

Other CPT codes related to the CPB:

80299 Quantitation of therapeutic drug, not elsewhere specified
84999 Unlisted chemistry procedure
85999 Unlisted hematology and coagulation procedure
87999 Unlisted microbiology procedure
88199 Unlisted cytopathology procedure
88299 Unlisted cytogenetic study
88399 Unlisted surgical pathology procedure

Test and panels that have no specific code(s):

Weight Management Profile, Fertility Profile, Dried Urine Metabolites, Complete Urine Metabolites, Urine Sex Steroid Metabolites, Urinary Free Cortisols

Aeron Life Cycles:

Other CPT codes related to the CPB:

80299 Quantitation of therapeutic drug, not elsewhere specified
84999 Unlisted chemistry procedure
85999 Unlisted hematology and coagulation procedure
87999 Unlisted microbiology procedure
88199 Unlisted cytopathology procedure
88299 Unlisted cytogenetic study
88399 Unlisted surgical pathology procedure

Test and panels that have no specific code(s):

Saliva Analysis, Urine Bone Marker, BPAssay

Aletess Medical Laboratory:

Other CPT codes related to the CPB:

80299 Quantitation of therapeutic drug, not elsewhere specified
84999 Unlisted chemistry procedure
85999 Unlisted hematology and coagulation procedure
87999 Unlisted microbiology procedure
88199 Unlisted cytopathology procedure
88299 Unlisted cytogenetic study
88399 Unlisted surgical pathology procedure

Moleculera Labs:

Other CPT codes related to the CPB:

83520 Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; quantitative, not otherwise specified
86352 Cellular function assay involving stimulation (eg, mitogen or antigen) and detection of biomarker (eg, ATP)
88230 Tissue culture for non-neoplastic disorders; lymphocyte

Test and panels that have no specific code(s):

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

Physician Labs:

Other CPT codes related to the CPB:

82175 Arsenic
82300 Cadmium
82533 Cortisol; total
82570 Creatinine; other source
82672 Estrogens; total
82679 Estrone
83018 Heavy metal (eg, arsenic, barium, beryllium, bismuth, antimony, mercury); quantitative, each
83566 Lead
83825 Mercury, quantitative
84403 Testosterone; total

Salveo diagnostic advanced blood/stool testing profiles/panels:

CPT codes not covered for indications listed in the CPB:

Salveo diagnostic advanced blood/stool testing profiles/panels - No specific code

Dried Urine Test for Comprehensive Hormones (DUTCH) testing:

CPT codes not covered for indications listed in the CPB:

Dried Urine Test for Comprehensive Hormones (DUTCH) testing- No specific code

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:

  1. digestion (gastrointestinal),
  2. nutrition,
  3. detoxification/oxidative stress,
  4. immunology/allergy,
  5. production and regulation of hormones (endocrinology), and/or
  6. 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:

  1. 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.
  2. 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.
  3. 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. 
  4. 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.
  5. 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.
  6. American Academy of Pediatrics. Clinical practice guideline: Diagnosis and evaluation of the child with attention-deficit/hyperactivity disorder. Pediatrics. 2000;105(5):1158-1170.
  7. 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.
  8. American College of Rheumatology Ad Hoc Committee on Clinical Guidelines. Guidelines for the management of rheumatoid arthritis. Arthritis Rheum. 1996;39(5):713-722.
  9. Ang DC, Calabrese LH. A common-sense approach to chronic fatigue in primary care. Cleve Clin J Med. 1999;66(6):343-350, 352..
  10. Blocker WP Jr, Ostermann HJ. Obesity: Evaluation and treatment. Dis Mon. 1996;42(12):829-873.
  11. 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.
  12. Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Diagnostic Breath Analyses (100.5). Baltimore, MD: CMS; effective June 12, 1984.
  13. 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.
  14. Griffin JW, Hsieh ST, McArthur JC, Cornblath DR. Laboratory testing in peripheral nerve disease. Neurol Clin. 1996;14(1):119-133.
  15. Hoffenberg EJ. Serologic testing for inflammatory bowel disease. J Pediatr. 1999;134(4):447-452.
  16. 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.
  17. McNicholas WT. Clinical diagnosis and assessment of obstructive sleep apnoea syndrome. Monaldi Arch Chest Dis. 1997;52(1):37-42.
  18. 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.
  19. 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.
  20. Pichichero M. PANDAS: Pediatric autoimmune neuropsychiatric disorder associated with group A streptococci. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed April 25, 2022.
  21. 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.
  22. 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.