Nonstandard Laboratory Test Panels Form
Procedure is not covered
Background for this Policy
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:
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.
Scope of Policy
This Clinical Policy Bulletin addresses nonstandard laboratory test panels.
Experimental and Investigational
Aetna considers laboratory test panels experimental and investigational if they include nonstandard tests that have no proven value. Laboratory test panels may also be considered experimental and investigational 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.
Aeron Life Cycles
Aetna considers the following test panels from Aeron Life Cycles experimental and investigational because of insufficient evidence:
Alletess Medical Laboratory
Aetna considers the following tests from Alletess Medical Laboratory experimental and investigational because of insufficient evidence:
BioHealth
Aetna considers the following BioHealth Test Panels experimental and investigational because of insufficient evidence:
DiagnosTechs
Aetna considers the following DiagnosTechs Laboratory Test Panels experimental and investigational because of insufficient evidence of their clinical value:
Doctor's Data Lab
Aetna considers the following Doctor's Data Lab Panels experimental and investigational, unless otherwise noted, because of insufficient evidence of their clinical value:
Nutritional
:
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.
Clinical Microbiology
Toxic and Essential Elements
Drinking Water Analysis
Bloodspot
DNA Methylation Pathway, Bloodspot.
Cardiovascular
Environmental Exposure/Detoxification
:
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.
Great Plains Laboratory
Aetna considers the following Great Plains Laboratory Test panels experimental and investigational because there is insufficient published peer-reviewed evidence of their clinical utility:
The following Great Plains Laboratory Tests and Panels are considered experimental and investigational:
††† Measurement of urine porphyrins is considered medically necessary for persons with signs and symptoms of porphyria.
Moleculera Labs
The following test panel from Moleculera Labs is considered experimental and investigational:
Physicians Lab
Physicians Lab urine panels are considered experimental and investigational, including:
ZRT Laboratory
The following test panels from ZRT Laboratory are considered experimental and investigational because of insufficient published, peer-reviewed evidence:
Other Laboratories
The following laboratories perform non-standard test panels that are considered experimental and investigational; most also perform various standard tests:
Walk through this policy with us
Review how this policy can be converted into cited criteria, prior authorization checks, and operational automation.