0300 Hair Analysis - Aetna Better Health

Prior Authorization Review Panel MCO Policy Submission

A separate copy of this form must accompany each policy submitted for review. Policies submitted without this form will not be considered for review.

Plan: Aetna Better Health

Submission Date: 05/01/2019

Policy Number: 0300 Policy Name: Hair Analysis

Effective Date: Revision Date: 06/28/2005

Type of Submission ? Check all that apply: New Policy Revised Policy Annual Review ? No Revisions*

*All revisions to the policy must be highlighted using track changes throughout the document. Please provide any clarifying information for the policy below:

CPB 0300 Hair Analysis

Clinical content was last revised on 06/28/2005. No additional non-clinical updates were made by Corporate since the last PARP submission.

Name of Authorized Individual (Please type or print):

Dr. Bernard Lewin, M.D.

Signature of Authorized Individual:

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Hair Analysis

Clinical Policy Bulletins Medical Clinical Policy Bulletins Number: 0300

Policy *Please see amendment for Pennsylvania Medicaid at the end of this CPB.

Aetna considers chemical hair analysis experimental and investigational, except for diagnosis of suspected chronic arsenic poisoning.

Note: Microscopic evaluation of hair structure (trichogram) may be medically necessary as part of the work-up of members with alopecia or abnormal-appearing or abnormally growing hair.

Note: Although hair samples may be used for verifying abuse of illicit substances in persons who wish to evade detection, its use in this situation is not considered treatment of disease.

Policy History

Last Review 07/25/2018 Effective: 10/13/199 Next Review: 03/14/2019

Review History

Definitions

Background

Hair analysis has been proposed as an aid in the diagnosis of disorders such as mineral or protein deficiency or mineral toxicity. Hair analysis has not been proven to be effective in ascertaining mineral or metabolic imbalances or IgE-mediated allergic diseases. Hair analysis has also not been proven to be of use in either the diagnosis or treatment of autism.

Additional Information



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Because arsenic is taken up and bound in hair and fingernails, analysis of hair and nails have been used to detect chronic arsenic exposure (Goldman, 2008). However, in a setting in which air exposure is a consideration, as in an industrial environment, it is very difficult to remove exogenous arsenic from hair, and therefore to get a reliable reading. Also a lack of standardization of analysis contributes to the variability of results from hair and nail testing. Goldman (2008) explained that commercial laboratory hair analyses for multiple elements including arsenic are highly inaccurate. Determination of arsenic in hair and nails has been most useful in epidemiological studies performed to evaluate environmental exposures of populations to inorganic arsenic; it is less useful in the evaluation of an individual patient (Goldman, 2008).

Microscopic evaluation of hair structure (trichogram) may be indicated as part of the work-up of members with alopecia or abnormal-appearing or abnormally growing hair. Hair may be examined under the microscope to determine the number of hairs that are actively growing (anagen phase) versus the resting phase (telogen). In addition, microscopic examination of clipped hair can reveal structural abnormalities of the hair bulb or shaft.

Rahman et al (2009) determined the concentration of trace elements present in scalp hair sample of schizophrenic patients and examined the relationship between trace elements level and nutritional status or socioeconomic factors. The study was conducted among 30 schizophrenic male patients and 30 healthy male volunteers. Hair trace element concentrations were determined by flame atomic absorption spectroscopy and analyzed by independent t-test, Pearson's correlation analysis, regression analysis, and analysis of variance (ANOVA). Mn, Zn, Ca, Cu, and Cd concentrations of schizophrenic patients were 3.8 +/- 2.31 microg/gm, 171.6 +/59.04 microg/gm, 396.23 +/- 157.83 microg/gm, 15.40 +/- 5.68 microg/gm, and 1.14 +/- 0.89 microg/gm of hair sample, while those of control subjects were 4.4 +/- 2.32 microg/gm, 199.16 +/- 27.85 microg/gm, 620.9 +/- 181.55 microg/gm, 12.23 +/4.56 microg/gm, and 0.47 +/- 0.32 microg/gm of hair sample, respectively. The hair concentration of Zn and Ca decreased significantly (p = 0.024; p = 0.000, respectively) and the concentration of Cu and Cd increased significantly (p = 0.021; p = 0.000, respectively) in schizophrenic patients while the concentration of Mn (p = 0.321) remain unchanged. Socioeconomic data reveals that most of the patients were poor, middle-aged and divorced. Mean body mass indices (BMIs) of the control group (22.26 +/- 1.91 kg/m(2)) and the patient group (20.42 +/- 3.16 kg/m (2)) were within the normal range (18.5 to 25.0 kg/m(2)). Pearson's correlation



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analysis suggested that only Ca concentration of patients had a significant positive correlation with the BMI (r = 0.597; p = 0.000) which was further justified from the regression analysis (R (2) = 44 %; t = 3.59; p = 0.002) and 1-way ANOVA test (F = 3.62; p = 0.015). A significant decrease in the hair concentration of Zn and Ca as well as a significant increase in the hair concentration of Cu and Cd in schizophrenic patients than that of its control group was observed, which may provide prognostic tool for the diagnosis and treatment of this disease. However, further work with larger population is suggested to examine the exact correlation between trace element level and the degree of disorder.

Guidelines from the National Institute for Health and Clinical Excellence (2011) recommended against the use of hair analysis in the diagnosis of food allergy. An NIAID expert panel (Boyce et a., 2010) made similar recommendations against the use of hair analysis in food allergy. Guidelines from the American Academy of Asthma, Allergy and Immunology (Wallace et al, 2008) state that hair analysis has no diagnostic validity in rhinitis. Autism guidelines from the Singapore Ministry of Health (2010) recommend against the use of hair mineral analysis for autism.

Albar et al (2013) stated that recently, hair cortisol has become a topic of global interest as a biomarker of chronic stress. Different research groups have been using different methods for extraction and analysis, making it difficult to compare results across studies. A critical examination of the reported analytical methods is important to facilitate standardization and allow for a uniform interpretation. These researchers qualitatively compared 4 published procedures from laboratories in Germany, the Netherlands, the United States of America and Canada. Multiple aspects of their procedures were compared. A major difference among the laboratories was the enzyme-linked immunosorbent assay (ELISA) kit used: the Canadian laboratory used the kit from ALPCO Diagnostics (Salem, MA), the American laboratory used the kit from DRG International (Springfield, NJ), the German laboratory used the kit from DRG Instruments GmbH (Marburg, Germany), or IBL (Hamburg, Germany), and the Dutch used the kit from Salimetrics (Suffolk, UK). In addition, there were noted differences in hair mass used as well as washing and extraction procedures. The range of hair cortisol levels determined in healthy volunteers by the 4 groups was within 2.3-fold: Koren, 46.1 pg/mg; Van Rossum, 29.72 pg/mg; Kirschbaum, 20 pg/mg and Laudenslager ~ 27 pg/mg. The authors concluded that the relative similarities in hair cortisol values in volunteers among the 4 laboratories should facilitate a quality assurance exchange program, as a necessary step toward clinical use of this novel test.



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Karlen and colleagues (2013) examined cortisol concentrations in hair as biomarker of prolonged stress in young children (n = 100) and their mothers and the relation to perinatal and socio-demographic factors. Prolonged stress levels were assessed through cortisol in hair. A questionnaire covered perinatal and socio-demographic factors during the child's first year of life. Maternal hair cortisol during the 2nd and 3rd trimester and child hair cortisol at year 1 and 3 correlated. Child cortisol in hair levels decreased over time and correlated to each succeeding age, between years 1 and 3 (r = 0.30, p = 0.002), 3 and 5 (r = 0.39, p < 0.001), and 5 and 8 (r = 0.44, p < 0.001). Repeated measures gave a significant linear association over time (p < 0.001). There was an association between high levels of hair cortisol and birth weight ( = 0.224, p = 0.020), non-appropriate size for gestational age ( = 0.231, p = 0.017), and living in an apartment compared with a house ( = 0.200, p = 0.049). In addition, these investigators found high levels of cortisol in hair related to other factors associated with psychosocial stress exposure. The authors concluded that correlation between hair cortisol levels in mothers and their children suggested a heritable trait or maternal calibration of the child's hypothalamic-pituitaryadrenocortical axis. Cortisol output gradually stabilizes and seems to have a stable trait. They stated that cortisol concentration in hair has the potential to become a biomarker of prolonged stress, especially applicable as a non-invasive method when studying how stress influences children's health.

Russell et al (2014) noted that cortisol is assumed to incorporate into hair via serum, sebum, and sweat sources; however, the extent to which sweat contributes to hair cortisol content is unknown. In this study, sweat and saliva samples were collected from 17 subjects after a period of intensive exercise and analyzed by salivary ELISA. Subsequently, an in-vitro test on exposure of hair to hydrocortisone was conducted. Residual hair samples were immersed in a 50-ng/ml hydrocortisone solution for periods lasting 15 mins to 24 hrs, followed by a wash or no-wash condition. Hair cortisol content was determined using the authors' modified protocol for a salivary ELISA. Post-exercise control sweat cortisol concentrations ranged from 8.16 to 141.7 ng/ml and correlated significantly with the log-transformed time of day. Sweat cortisol levels significantly correlated with salivary cortisol concentrations. In-vitro hair exposure to a 50-ng/ml hydrocortisone solution (mimicking sweat) for 60 mins or more resulted in significantly increased hair cortisol concentrations. Washing with isopropanol did not affect immersionincreased hair cortisol concentrations. The authors concluded that human sweat contains cortisol in concentrations comparable with salivary cortisol levels. The findings of this study suggested that perfuse sweating after intense exercise may



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