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«Oxford UnitedHealthcare® Oxford Clinical Policy OTOACOUSTIC EMISSIONS TESTING Policy Number: ENT 020.10 T1 Effective Date: October 1, 2016 Table of ...»

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Oxford

UnitedHealthcare® Oxford

Clinical Policy

OTOACOUSTIC EMISSIONS TESTING

Policy Number: ENT 020.10 T1 Effective Date: October 1, 2016

Table of Contents Page Related Policies

INSTRUCTIONS FOR USE

CONDITIONS OF COVERAGE

BENEFIT CONSIDERATIONS

COVERAGE RATIONALE

APPLICABLE CODES

DESCRIPTION OF SERVICES

CLINICAL EVIDENCE

U.S. FOOD AND DRUG ADMINISTRATION

REFERENCES

POLICY HISTORY/REVISION INFORMATION................ 12

INSTRUCTIONS FOR USE

This Clinical Policy provides assistance in interpreting Oxford benefit plans. Unless otherwise stated, Oxford policies do not apply to Medicare Advantage members. Oxford reserves the right, in its sole discretion, to modify its policies as necessary. This Clinical Policy is provided for informational purposes. It does not constitute medical advice. The term Oxford includes Oxford Health Plans, LLC and all of its subsidiaries as appropriate for these policies.

When deciding coverage, the member specific benefit plan document must be referenced. The terms of the member specific benefit plan document [e.g., Certificate of Coverage (COC), Schedule of Benefits (SOB), and/or Summary Plan Description (SPD)] may differ greatly from the standard benefit plan upon which this Clinical Policy is based. In the event of a conflict, the member specific benefit plan document supersedes this Clinical Policy. All reviewers must first identify member eligibility, any federal or state regulatory requirements, and the member specific benefit plan coverage prior to use of this Clinical Policy. Other Policies may apply.

UnitedHealthcare may also use tools developed by third parties, such as the MCG™ Care Guidelines, to assist us in administering health benefits. The MCG™ Care Guidelines are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice.

CONDITIONS OF COVERAGE

Applicable Lines of Business/Products This policy applies to Oxford Commercial plan

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BENEFIT CONSIDERATIONS

Before using this policy, please check the member specific benefit plan document and any federal or state mandates, if applicable.

Essential Health Benefits for Individual and Small Group For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured non-grandfathered individual and small group plans (inside and outside of Exchanges) to provide coverage for ten categories of Essential Health Benefits (“EHBs”). Large group plans (both self-funded and fully insured), and small group ASO plans, are not subject to the requirement to offer coverage for EHBs. However, if such plans choose to provide coverage for benefits which are deemed EHBs, the ACA requires all dollar limits on those benefits to be removed on all Grandfathered and Non-Grandfathered plans. The determination of which benefits constitute EHBs is made on a state by state basis. As such, when using this policy, it is important to refer to the member specific benefit plan document to determine benefit coverage.

COVERAGE RATIONALE

Neonatal hearing screening as a preventive service using otoacoustic emissions (OAEs) is proven and medically necessary for infants who are 90 days or younger.

Otoacoustic emissions (OAEs) testing as a diagnostic service is proven and medically necessary for the

evaluation of hearing loss in one or more of the following:

 Infants over 90 days old and children up to 4 years of age  Children and adults who are or who are unable to cooperate with other methods of hearing testing (e.g.

individuals with autism or stroke)  Children with developmental or delayed speech or language disorders  Individuals with tinnitus, acoustic trauma, noise induced hearing loss, or sudden hearing loss  Individuals with abnormal auditory perception  Individuals with sensorineural hearing loss  Individuals with abnormal auditory function studies or failed hearing exam  Individuals who may be feigning a hearing loss  Monitoring of ototoxicity in patients before, during, and after administration of agents known to be ototoxic (e.g., aminoglycosides, chemotherapy agents) Auditory screening or diagnostic testing using otoacoustic emissions (OAEs) is unproven and not medically necessary for all other patient populations and conditions other than those listed as proven and medically necessary.

There is inadequate evidence that hearing screening with OAEs is superior to screening audiometry in improving health outcomes such as timely facilitation of speech, language, and communication skills in older children or adults.

There is also inadequate evidence to indicate that the use of diagnostic otoacoustic emissions (OAEs) testing is superior to screening audiometry in improving health outcomes such as timely facilitation of speech, language, and communication skills in patients with other conditions other than those indicated as proven and medically necessary.

APPLICABLE CODES





The following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this policy does not imply that the service described by the code is a covered or noncovered health service. Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment. Other Policies may apply.

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DESCRIPTION OF SERVICES

Otoacoustic emissions (OAEs) are low-intensity sounds emitted by functioning outer hair cells of the cochlea. OAEs are measured by acoustic stimuli such as a series of very brief clicks to the ear through a probe that is inserted in the outer third of the ear canal. The probe contains loudspeakers that generate the clicks and a microphone for measuring the resulting OAEs. OAE testing requires no behavioral or interactive feedback by the individual being tested.

OAEs are used as a screening test for hearing in newborns. Other potential applications of OAE testing include screening children or at-risk populations for hearing loss, and characterizing sensitivity and functional hearing loss and differentiating sensory from neural components in people with known hearing loss.

OAE devices use either transient evoked OAE (TEOAE) or distortion product EOE (DPOAE) technology. TEOAE devices emit a single brief click that covers a broad frequency range. DPOAE devices emit two brief tones set at two separate frequencies. TEOAEs are used to screen infants, validate other tests, and assess cochlear function, and DPOAEs are used to assess cochlear damage, ototoxicity, and noise-induced damage. Spontaneous otoacoustic emissions (SOAEs) are sounds emitted without an acoustic stimulus (i.e., spontaneously). Stimulus-frequency otoacoustic emissions (SFOAEs) are sounds emitted in response to a continuous tone. At present, SOAEs and SFOAEs are not used clinically.

The OAE measures are effective for screening middle-ear abnormalities and moderate or severe degrees of hearing loss, because normal OAE responses are not obtained if hearing thresholds are approximately 30- to 40-dB hearing levels or higher. The OAE test does not further quantify hearing loss or hearing threshold level. The OAE test also does not assess the integrity of the neural transmission of sound from the eighth nerve to the brainstem and, therefore, will miss auditory neuropathy and other neuronal abnormalities. Individuals with such abnormalities will have normal OAE test results but abnormal auditory brainstem response (ABR) test results (Harlor, 2009).

CLINICAL EVIDENCE

Otoacoustic Emissions (OAEs) for Neonatal Hearing Screening A study which involved 53,781 newborns provided a direct comparison of hearing impairment detection rates during periods of newborn hearing screening and no screening in the same hospitals (Wessex Universal Hearing Screening Trial, 1998). Those infants born during a period of screening underwent a two-stage screening test, with transient evoked otoacoustic emissions (TEOAE) at birth, followed by automated auditory brainstem response (AABR) before discharge if the first screen was failed. If the second screen was also failed, the babies were referred to an audiologist at 6 to 12 weeks of age. In this study, 4% of infants with hearing loss were missed during the screening period, while 27% were missed during the period of no screening. This study did not provide data on clinical outcomes such as speech and language development in screened versus unscreened children.

Another group of investigators compared clinical outcomes, including speech and language development, in 25 infants who were screened as part of the Colorado Universal Newborn Screening program with outcomes in 25 matched infants who were born in a hospital without a universal newborn hearing screening program (Yoshinaga-Itano et al., 2000). This study found that children who were identified as hearing impaired through the newborn hearing screening program had significantly better scores on tests of speech and language development than did children who were identified later.

Professional Societies and Guidelines U.S. Preventive Services Task Force (USPSTF)

The USPSTF recommends that newborn hearing screening programs include (USPSTF, 2008):

 a 1- or 2-step validated protocol which includes otoacoustic emissions (OAEs) followed by auditory brainstem response (ABR) in those who failed the first test  quality-control programs in place to reduce avoidable false-positive test results

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The Joint Committee on Infant Hearing (JCIH) The JCIH, which includes organizations such as the American Academy of Pediatrics (AAP), the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS), the American Academy of Audiology (AAA), and American Speech-Language-Hearing Association (ASHA), has a published position statement on principles and guidelines for early hearing detection and intervention programs. The JCIH endorses early detection of and intervention for infants with hearing loss. To maximize the outcome for infants who are deaf or hard of hearing, the hearing of all infants should be screened at no later than 1 month of age. Those who do not pass screening should have a comprehensive audiological evaluation at no later than 3 months of age. Infants with confirmed hearing loss should receive appropriate intervention at no later than 6 months of age from health care and education professionals with expertise in hearing loss and deafness in infants and young children. Separate protocols are recommended for NICU and wellinfant nurseries. NICU infants admitted for more than five days are to have auditory brainstem response (ABR) included as part of their screening so that neural hearing loss will not be missed. For infants who do not pass automated ABR testing in the NICU, referral should be made directly to an audiologist for re-screening and, when indicated, comprehensive evaluation including ABR (JCIH, 2007).

American Academy of Pediatrics (AAP) In February 1999, the American Academy of Pediatrics endorsed the implementation of universal newborn hearing screening (AAP, 1999).

National Institutes of Health (NIH) An NIH Consensus Statement concluded that there is no ideal method for screening hearing (NIH, 1993). In the absence of an ideal screening program, the NIH recommends universal two-stage EOAE and ABR screening of all infants prior to hospital discharge, or within the first 3 months of life for infants born at an alternate birthing site. The NIH also states that universal hearing screening is superior to a hearing protocol that screens only neonates with high-risk indicators; a high-risk protocol identifies only 50% of hearing-impaired infants.

OAE Evaluation for Hearing Loss in Children Rowe et al (2016) Assessment of hearing in children is important because early identification of hearing loss results in better developmental and educational outcomes. In the UK slightly more than 1 in 1000 children have significant permanent hearing loss diagnosed by the Neonatal Hearing Screening Programme (NHSP). This is based on Otoacoustic Emission (OAE) testing and Auditory Brainstem Response Testing (ABR). OAE testing is performed in the first few weeks of life and identifies infants who warrant further testing with automated ABR. Automated ABR uses an encephalogram to monitor response to sounds. Infants who meet the ‘high risk’ criteria will be referred directly for automated ABR testing. If automated ABR suggests abnormality the child is referred for diagnostic ABR testing, which is a more detailed investigation capable of giving actual hearing thresholds and differentiating between conductive and sensorineural hearing loss.

Chiong et al. (2007) evaluated evoked otoacoustic emission (OAE) and auditory brainstem response (ABR) results for hearing screening in infants. The objective of the study was to correlate hearing screening outcomes of a cohort of infants with developmental outcomes at 6 and 12 months. A total of 565 infants had both OAE testing and ABR.

Overall in 1130 ears, OAE and ABR testing showed an observed agreement of 99%, agreement due to chance of 96%, and kappa agreement of 79% in diagnosing bilateral hearing losses. OAEs had a sensitivity of 86.4% and a specificity of 99.4%.



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