Clinical Policy Title: Bone Anchored Hearing Aids (BAHAs) and Cochlear Implants

Transcription

1 Clinical Policy Title: Bone Anchored Hearing Aids (BAHAs) and Cochlear Implants Clinical Policy Number: Effective Date: June 1, 2014 Initial Review Date: Jan. 15, 2014 Most Recent Review Date: Jan. 21, 2015 Next Review Date: Jan Related Policies: None. conta Conductive hearing loss. Sensorineural hearing loss. Children and adults. Uni-or-bilateral. FM hearing assist systems. ABOUT THIS POLICY: Keystone First has developed clinical policies to assist with making coverage determinations. Keystone First s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by Keystone First when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. Keystone First s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. Keystone First s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, Keystone First will update its clinical policies as necessary. Keystone First s clinical policies are not guarantees of payment. Coverage Policy Keystone First considers the use of BAHAs and cochlear implants to be clinically proven and therefore, medically necessary when the following criteria are met: BAHA: Post-lingual (> 5 years) and uni- or bi-lateral conductive or mixed (conductive and sensorineural) hearing loss where conventional air conduction hearing aid is ineffective or contraindicated AND (any): Congenital or surgically induced external ear canal or middle ear malformation. External ear dermatitis including hypersensitivity reaction to conventional hearing aid. Hearing loss secondary to otosclerosis that is not amenable to surgical correction. Severe chronic otitis externa or otitis media. External ear canal or tympanic cavity tumors; or Other contraindications to conventional hearing aid use. Cochlear implant Unilateral implantation: severe/profound deafness and inadequate benefit from conventional acoustic hearing aids. 1

2 Bilateral implants: severe/profound deafness in children; adults who are blind or have other disabilities increasing reliance on auditory stimuli for spatial awareness. Limitations: Either device only after assessment and documentation by multidisciplinary team; and 3 month trial of conventional hearing aid; and Treatment center manages at least 15 new cases per year. Alternative Covered Services: Physician office visits and speech therapy. Summary of evidence, below: Background Hearing loss; impairment; or deafness: Among the most common sensory disorders, hearing loss can present at any age and is experienced by approximately 10% of adults. One third of those over 65 have losses sufficient to need hearing aids. It can be associated with age, noise exposure, physical or chemical trauma, or with disease (including genetic and infectious) and is generally classified as conductive or sensorineural. Hearing loss can result from disorders along the normal pathway for transmission of sound into electrical energy from the auricle (external ear), external auditory canal, middle and inner ears, to central auditory pathways in the brain. Disruptions of this pathway are called conductive hearing loss. Sensorineural hearing loss: deficits associated with the vestibulocochlear nerve (Cranial VII), the inner ear or central brain processing centers. In many cases the problem can be localized to hair cells in the organ of Corti within the cochlea. Conductive hearing loss often is amenable to surgical correction, while sensorineural losses are more difficult to manage. Mild, moderate or even more severe sensorineural losses are regularly rehabilitated with hearing aids of varying strength and configuration: the current generation having been miniaturized for placement entirely within the ear canal, thus avoiding stigma associated with use. People with unilateral loss often have difficulty with localization and reduced clarity in background noise; they may benefit from a CROS (contralateral routing of signal) aid, in which a microphone of the impaired side transmits to a receiver on the other. Bone-anchored hearing aids achieve a similar result by vibrating the skull. Patients with profound deafness on one side and some loss on the other may be candidates for a BICROS aid, in which the patient wears a hearing aid rather than a receiver in the better ear. Even these relatively sophisticated technologies may be judged unsatisfactory by patients. Bone-anchored hearing aids (BAHA) transmit sound vibration to the inner ear by direct bone conduction through the skull. Their intent is to improve acuity in moderate to severe conductive or mixed hearing loss for individuals unable to use or dissatisfied with conventional air conduction hearing aids. Cochlear implants are used in patients with bilateral hearing impairment due to severe loss of cochlear hair cells. Implants restore hearing by converting sound into electrical impulses that stimulate the auditory nerve (functions normally performed by hair cells). Implantation may be uni- or bi-lateral, with the latter intending to more closely simulate normal hearing. 2

3 Arguments against bilateral implants (simultaneous or sequential) include: Preserving contralateral ear for future technology. Damage to residual hearing since implants destroy hair cells. Additional anesthesia. Potential harm to vestibular system. Cincinnati Children s Hospital (2011; Table below) concludes that concerns have been addressed: Implantation in children is reliable and safe in experienced hands (low rate of serious complications). However, costs to hospital and family (device and accessories, follow up therapy and programming sessions; life-long support) warrant further investigation. Frequency modulation (FM) hearing assistive systems: miniature radio stations operating on special frequencies, the personal FM system consists of a transmitter microphone used by a speaker (typically a classroom teacher or lecturer) and a receiver used by the listener, which transmits sound directly to the ear or to a hearing aid, cochlear implant, or headset. Methods Searches (January, 2015): Keystone First searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services. Searches were conducted on January 13, 2015 using the terms bone- anchored hearing aid cochlear implant, and frequency modulation system. Included were: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Summary of findings: bone-anchored hearing aids (BAHAs) While available evidence is methodologically weak, BAHAs improve hearing and QoL compared to unaided hearing. There is some evidence for additional benefit from bilateral Vs uni-lateral BAHAs. Summary of findings: cochlear implants 3

4 Cochlear implantation requires complex case evaluation, surgery, and rehabilitation but unilateral implantation is generally safe and effective for children and adults with severe/profound postlingual hearing loss. Bilateral implants may confer additional benefits. Outcomes vary due to a broad spectrum of adverse influences. Frequency modulation systems: represented by one systematic review only (McCreery, 2012) and that review found evidence too limited for strong conclusions for or against use in school-age children. Citation Hayes (2013) Hayes (2013a) McCreery (2012) Content, Methods, Recommendations Bilateral cochlear implantation in adults: Substantial body of evidence: second cochlear implant in adults with severe/profound post- lingual sensorineural loss improves speech perception and localization in noise conditions but studies did not evaluate language proficiency. Several small studies, for functional improvement or QoL. Post-procedure auditory rehabilitation required. Bilateral cochlear implantation in children: Substantial evidence that bilateral improves speech perception and localization Vs single implant for children and adolescents with severe/profound post-lingual bilateral deafness that will receive post-procedure auditory rehabilitation, and have no other significant disabilities or structural abnormalities. Directional microphones & digital noise reduction hearing aids in school age children: RCTs,1980-; 4 noise reduction, 7 directional microphone studies in 9 articles, none of which reported audibility outcomes. Digital noise reduction did not improve or degrade speech recognition; complex learning tasks unaffected. Directional microphones improved speech recognition in controlled settings with speaker in front of listener. Overall, evidence of low/moderate quality, additional research needed. Black (2011) Cincinnati Children s Hospital (2011) Colquitt (2011) Summerfield (2010) Prognostic indicators for pediatric cochlear implants: Heterogeneity precluded meta-analysis. Eligible well-conducted studies few: only 4 adverse indicators identified: age at implantation; Connexin 26; inner ear malformations; meningitis. Relevant adverse factors largely unreported. Quality of life in children with sequential bilateral cochlear implants: Best evidence for domain, Insufficient evidence for sequential Vs unilateral to improve QoL. Bone-anchored hearing aids for bilateral deafness: Prospective comparisons with conventional hearing aids, unaided hearing, or surgery, - November Available evidence methodologically weak. Hearing and QoL improved vs. unaided. Some evidence for bilateral vs. unilateral. Cost-effectiveness of pediatric bilateral cochlear implants: potentially cost-effective for young deaf children but considerable uncertainty in QoL estimates. Bond (2009) Cochlear implants for severe to profound deafness in children > 12 months and adults: English-language CCTs or cross-sectional, - July

5 Citation Content, Methods, Recommendations Despite reservations re study quality: unilateral implantation is safe and effective; bilateral may provide additional gain. NICE (2009) UK National institute for Health and Clinical Excellence ANZHSN (2005) Australia & New Zealand Horizon Scanning Network Bergeron (2006) Cochlear Implants for children and adults with severe to profound deafness: Systematic reviews, and RCTs, - July Unilateral implantation: an option for people with severe/profound deafness and inadequate benefit from conventional acoustic hearing aids. Bilateral implants: severe/profound deafness in children; adults who are blind or have other disabilities increasing reliance on auditory stimuli for spatial awareness. Implantation only after assessment by multidisciplinary team AND after 3 month trial of conventional hearing aid. Bone anchored hearing aids: Insufficient evidence. Bone-anchored hearing aids: Information is limited but generally supports effectiveness. Beyond experimental stage for users of bone conduction hearing aids and users of conventional aids. Developmental status restricts implantation to centers with specialized technical platform (teams including an otorhino-laryngologist, audiologist, pediatric anesthesiologist for children, and treating at least 15 new cases/yr; Eligibility criteria: > 5 years. Experimental: bilateral implantation; unilateral sensorineural loss; tinnitus; Additional trials and economic evaluations needed. Hayes (2005) UK Cochlear Implant Study Group (2004) Cheng (2000) Bone-anchored hearing aids: Several prospective studies with patients as their own controls and an unspecified number of retrospective studies: significant improvements in functional gain, speech perception, hearing ability in range of environments Vs conventional air conduction aids for moderate/severe conductive or mixed hearing loss. (Hayes rating D: concerns re safety and/or efficacy). Cost-effectiveness of unilateral implants in post-lingually deafened adults: majority of subjects experienced increased QALYs. Cost-utility in children: Average age 7.5 yrs. Subgroup analyses for pre- or post-lingual deafness not reported. But overall positive effects at reasonable direct cost and net savings to society. Glossary Connexin26- A protein in which defects are responsible for the most common form of congenital deafness in developed countries. Otosclerosis- An abnormal bone growth in the middle ear that causes hearing loss. 5

6 Otitis media - Middle ear infection. Post-lingual, literally after language -In this context the onset of deafness after a child acquires language and speaks intelligibly. While there is wide variation in the age at which this happens, typical milestones include: cooing and babbling before 12 months; stringing sounds together into word approximations around 9 months; understanding and following simple one-step directions (12-15 months); words (age 2); too many words to count and 3 or more word sentences (2 to 3 years). Delays may be attributable to global developmental delay, anatomical problems in oral structures involved in speech, or hearing disorders. Speech and hearing are closely related, with each other, and with language acquisition as usually understood: the obvious exception: the versions of Sign (Sacks, 1989). Sacks goes on to document a critical age for language acquisition: before 5 years in all neurologically normal humans, hearing AND deaf. Once the window of opportunity for language passes, individuals are less likely to attain optimal grammar or fluency in language, spoken or signed. Advocates for deafness as a cultural rather than exclusively medical construct add the critical age to arguments for deaf children of hearing parents learning Sign in nursery schools. Hence the reviews in the table above stipulating postlingual hearing loss among eligibility criteria for cochlear implantation. Related Policies: Keystone First Utilization Management program description. References Professional society guidelines/others: Australia and New Zealand Horizon Scanning Network (ANZHSN). National Horizon Scanning Unit. Horizon scanning prioritizing summary. Bone anchored hearing aid (BAHA). Volume 8, Number 3. Adelaide Health Technology Assessment. February Bergeron F. Bone-anchored hearing aids. Montreal: Agence d evaluation des technologies et des modes d intervention en santé (AETMIS) Cincinnati Children s Hospital Medical Center. Best evidence statement (BESt). Quality of life in children with sequential bilateral cochlear implants. Cincinnati (OH): Cincinnati Children s Hospital Medical Center Hayes, Inc. Bilateral cochlear implantation in adults. Hayes Directory pocket summary. July 15, Hayes, Inc. Bilateral cochlear implantation in children. Hayes Directory pocket summary. July 15, Hayes, Inc. Bone-anchored hearing aids. Hayes Technology Directory pocket summary. June 3, Medica; Advisory Secretariat Ministry of Health and Long-Term Care. Bone anchored hearing aid: an evidence-based analysis. Ontario Health Technology Assessment Series 2002; 2(3): 47 pages. Ontario (Canada): September National Institute for Health and Clinical Excellence. Cochlear implants for children and adults with severe to profound deafness. London: National Institute for Health and Clinical Excellence (NICE). Technology Appraisal Guidance

7 Sacks, OW. Seeing Voices. A journey into the world of the deaf. University of California Press. Berkeley and Los Angeles Peer-reviewed references: Black J, Hickson L, Black B, Perry C. Prognostic indicators in pediatric cochlear implant surgery: a systematic literature review. Cochlear Implants International. 2011; 12(2): Bond M, Mealing S, Anderson R, Elston J, Weiner G, Taylor RS, Hoyle M, Liu Z, Price A, Stein K. The effectiveness and cost-effectiveness of cochlear implants for severe to profound deafness in children: a systematic review and economic model. Health Technology Assessment. 2009; 13(44): Cheng AK, Rubin HR, Powe NR, Mellon NK, Francis HW, Niparko JK. Cost-utility analysis of the cochlear implant in children. Journal of the American Medical Association.2000; 284(7): Colquitt JL, Jones J, Harris P, Loveman E, Bird A, Clegg AJ, Baguley DM, Proops DW, Mitchell TE, Sheehan PZ, Welch K. Bone-anchored hearing aids (BAHAs) for people who are bilaterally deaf: a systematic review and economic evaluation. Health Technology Assessment.2011; 15(26): Lin FR, Niparko JK, Francis HW. Outcomes in cochlear implantation: assessment of quality of life impact and economic evaluation of the cochlear implant. In: Eisenberg LS(ed.). Clinical Management of Children with Cochlear Implants (2 nd edition).san Diego, USA: Plural Publishing McCreery RW, Venediktov RA, Leech HM. An evidenced-based systematic review of directional microphones and digital noise reduction hearing aids in school-age children with hearing loss. American Journal of Audiology.2012; 21(2): ). Summerfield AQ, Lovett RE, Bellinger H, Batten G. Estimates of the cost-effectiveness of pediatric bilateral cochlear implantation. Ear and Hearing.2010; 31(5): UK Cochlear Implant Study Group. Criteria of candidacy for unilateral cochlear implantation in postlingually deafened adults: cost-effectiveness analysis. Ear and Hearing.2004; 25(4): Clinical Trials: The summary of evidence table covers all study types published through Searches conducted at on 1/13/2015 using bone anchored hearing aid and cochlear implant identified a total of 115 studies. Physicians interested in supporting research participation should consult the web site for studies clinically relevant to individual patients. Centers for Medicare and Medicaid Services (CMS) National Coverage Determination CMS. Auditory osseointegrated and auditory brainstem devices. Change request #4038. effective 11/10/2005; updated 2/16/2013. CMS. National coverage determination (NCD) for cochlear implantation (50.3). Publication number 100.3; manual section Effective 4/4/

8 Commonly Submitted Codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill in accordance with those manuals. CPT Code Description Comment ICD-9 Code Description Comment ICD-10 Code Description Comment HCPCS Level II Description Comment 8