Health Insurance Coverage of Cochlear Implantation in Single-Sided Deafness and Asymmetric Hearing Loss.

OBJECTIVE: There is increasing interest in providing cochlear implants (CIs) in single-sided deafness (SSD) or asymmetric hearing loss (AHL). CI clinics have experienced a range of outcomes when seeking insurance coverage for patients. The study explored the extent to which CI clinics were able to secure insurance coverage and whether there were differences in successfully gaining such coverage. STUDY DESIGN: A SurveyMonkey questionnaire was used to collect data from US CI clinicians. Respondents were from all regions of the United States and represented a diversity of clinic types including hospitals, university-based clinics, private clinics, and schools. Data were collected during August-October 2021 from 105 respondents regarding their clinic's experience in gaining health insurance coverage for pediatric and adult patients who had SSD or AHL. Strategies that had been used for gaining coverage after an initial denial were explored. Interviews were conducted with some respondents to gain additional insights beyond the survey. RESULTS: There was a substantial increase in the number of SSD operations conducted after 2019, the year when the Food and Drug Administration (FDA) manufacturer criteria expanded to include CI in SSD and AHL. Respondents were grouped into four categories based on volume of SSD operations before 2019 (≤10, 11-29, 30-49, and ≥50). The number of SSD operations after 2019 went up in all categories except for the 10 or less category, which declined by 43%. A minority of respondents indicated that they were able to obtain SSD insurance coverage infrequently (5%) or almost never (8%). Peer-to-peer review was the most successful approach to overturning an initial denial. Many clinics note that they are nearly always declined for SSD coverage on the first submission and must appeal. CONCLUSIONS: There is variability in CI coverage for SSD and AHL. Some health insurance coverage is available for patients of all ages, although some clinics note more difficulty gaining coverage for children younger than 5 years because of the FDA criteria. Clinicians are most successful at gaining coverage after an initial denial with peer-to-peer review, although the process is time-consuming and delays surgery. Efforts to expand access to CIs in SSD for children and adults who may benefit might best be addressed by reflecting on what was done to expand insurance coverage in bilateral deafness-a process that depended on relevant clinical research; research presented to the FDA for guidelines change; information sharing with the general public and constituencies in the hearing loss field including professionals, parent, and consumer organizations; and ongoing advocacy for change with insurers. To date, outcomes research in young children with CI in SSD is limited. Until such research is conducted and published, insurers will continue to argue that other rehabilitative options are approved and available.

Current Estimates of Cochlear Implant Utilization in the United States.

OBJECTIVE: To present key data from a private marketing report that characterizes U.S. cochlear implant (CI) utilization, potential CI candidate and recipient population sizes, and CI market growth. PATIENTS: Individuals who may benefit from CI and CI recipients in the United States. INTERVENTIONS: Cochlear implantation. MAIN OUTCOME MEASURES: CI utilization, potential CI candidate and recipient population sizes, and CI market size and value. RESULTS: As of 2015, a cumulative 170,252 people (240,056 devices) had undergone cochlear implantation in the United States. In the year 2015, approximately 30% of devices were implanted in bilateral CI patients, through simultaneous or sequential implantation. When considering traditional audiometric CI candidacy criteria (patients with severe to profound sensorineural hearing loss in the better hearing ear), utilization rates among the population who may benefit from CI approximated 12.7%. When considering expanded criteria including individuals with single-sided deafness or asymmetrical hearing loss (severe to profound hearing loss in the worse hearing ear), utilization rates approximated 2.1%. In 2015, there was a net increase of 20,093 individuals who may have benefited from CI who had not undergone CI, adding to the group of about 1.3 M untreated audiometric CI candidates who existed prior to that year. The CI market was valued at $450.8 M in 2015, with an average device selling price of $25,701 per device. CONCLUSIONS: CI utilization rates remain low among individuals who meet audiometric criteria for CI. Although the annual proportion of CI recipients to new audiometric candidates has increased, the total population of untreated audiometric CI candidates continues to rise.

Barriers to Adult Cochlear Implant Care in the United States: An Analysis of Health Care Delivery.

Persistent underutilization of cochlear implants (CIs) in the United States is in part a reflection of a lack of hearing health knowledge and the complexities of care delivery in the treatment of sensorineural hearing loss. An evaluation of the patient experience through the CI health care delivery process systematically exposes barriers that must be overcome to undergo treatment for moderate-to-severe hearing loss. This review analyzes patient-facing obstacles including diagnosis of hearing loss, CI candidate identification and referral to surgeon, CI evaluation and candidacy criteria interpretation, and lastly CI surgery and rehabilitation. Pervasive throughout the process are several themes which demand attention in addressing inequities in hearing health disparities in the United States.

Impact of Medicaid on Cochlear Implant Access.

OBJECTIVE: The study documented the role of Medicaid in the provision of cochlear implants and identified access barriers due to states' adopted rules. An historical review of federal legislation provided a basis for evaluating the original Congressional intent and how this national purpose aligns with how state programs are currently operating. STUDY DESIGN: A SurveyMonkey questionnaire was used to facilitate data collection from 47 clinics across 35 states after an initial inquiry was made to each clinic to determine an appropriate point of contact, generally a cochlear implant audiologist. Respondents were from all regions of the United States and represented a diversity of clinic types of varying program size. Data were collected for two calendar years-2015 and 2016. RESULTS: Medicaid was the funding source for an average of 55% of pediatric surgeries based on 36 US clinics. For the 23 clinics returning information on adults, Medicaid was the health insurer for an average (mean) of 22% of cochlear implants (CI) surgeries; the median was 13%. Four access concerns were identified: 1) equipment replacement and processor upgrade policies; 2) low reimbursement by state Medicaid for cochlear implant surgery and related services; 3) Medicaid Managed Care (MCO) and the complexity these providers can add for a specialized service like CI that is offered at a limited number of facilities; and 4) obtaining authorization for CI surgery and related services. CONCLUSIONS: The intent of the 1989 legislative changes in Medicaid was to ensure that children received appropriate healthcare services wherever they lived in the country. What has transpired over the years, vis-à-vis CI, is a Medicaid system that varies depending upon the state's individual rules.

Cochlear Implant Access in Six Developed Countries.

BACKGROUND: Access to cochlear implantation varies greatly around the world. It is affected by factors that are specific to each country's health care system, by awareness, and by societal attitudes regarding deafness. METHODS: Cochlear implant clinicians and researchers from six countries explored and discussed these variations and their likely causes: Robert Briggs from Australia; Wolfe-Dieter Baumgartner from Austria; Thomas Lenarz from Germany; Eva Koltharp from Sweden; Christopher Raine from the United Kingdom, and Craig Buchman, Donna Sorkin, and Christine Yoshinago from the United States. RESULTS: Utilization rates are quite different for the pediatric and adult demographics in all six countries. Pediatric utilization ranges in the six countries (all in the developed world) ranged from a low of 50% in the United States to a high of 97% in Australia. Adult utilization is less than 10% everywhere in the world. CONCLUSIONS: Pediatric access to care was excellent for children with the exception of Germany and the United States where there is an inadequate referral system. Adult utilization was low everywhere because of the lack of screening for adults and the fact that primary care physicians and even audiologists are unfamiliar with CI candidacy criteria and outcomes, and hence typically do not make patient referrals.

Psychosocial Aspects of Hearing Loss in Children.

Pediatric hearing loss changed more in the past two decades than it had in the prior 100 years with children now identified in the first weeks of life and fit early with amplification. Dramatic improvements in hearing technology allow children the opportunity to listen, speak and read on par with typically hearing peers. National laws mandate that public and private schools, workplaces, and anywhere people go must be accessible to individuals with disabilities. In 2015, most children with hearing loss attended mainstream schools with typically hearing peers. Psychosocial skills still present challenges for some children with hearing loss.

Cochlear implantation in the world's largest medical device market: utilization and awareness of cochlear implants in the United States.

Provision of cochlear implants (CIs) for those within the criteria for implantation remains lower in the United States than in some other developed nations. When adults and children are grouped together, the rate of utilization/provision remains low at around 6%. For children, the provision rate is about 50% of those who could benefit from an implant, compared with figures of about 90% for the Flanders part of Belgium, the United Kingdom and other European countries. The probable reasons for this underprovision include: low awareness of the benefits of CIs among the population; low awareness among health-care professionals; the lack of specific referral pathways; some political issues relating to the Deaf Community; and financial issues related to health provision. Such financial issues result in situations which either fail to provide for access to implants or provide too low a level of the necessary funding, especially for low-income individuals covered by public health-care programs such as Medicaid. These issues might be mitigated by adoption and publication of standards for best clinical practices for CI provision, availability of current cost-effectiveness data, and the existence of an organization dedicated to cochlear implantation. Such an organization, the American Cochlear Implant Alliance (ACI Alliance), was recently organized and is described in the paper by Niparko et al. in this Supplement.

Parental perspectives regarding early intervention and its role in cochlear implantation in children.

OBJECTIVE: To examine parental perspectives regarding services provided to families of hearing-impaired children under federally funded early-intervention (EI) programs with respect to support of cochlear implantation. Furthermore, to examine if family ethnicity or income was correlated with use of cochlear implants. STUDY DESIGN: A 4-page retrospective survey was mailed to parents of children who received Nucleus cochlear implants. SETTING: Surveys were sent to parents' registered home addresses. PATIENTS: A random stratified sample of 300 parents residing in the United States was drawn from the registration database maintained by Cochlear Americas. INTERVENTION: Surveys were administered after the children received a cochlear implant. MAIN OUTCOME MEASURES: Family ratings of perceived bias during advisement, services received under EI and difficulty accessing such services, and family's socioeconomic status and ethnicity. RESULTS: Children who were non-Caucasian and of lower socioeconomic status were underrepresented in the cochlear implant population. Parents noted a lack of "comprehensive and bias-free" information regarding communication options and technology under EI and sometimes experienced difficulty in obtaining certain services. CONCLUSION: Early-intervention professionals are the common denominator for families seeking information and services because they explain, help initiate, and expedite diagnostic and treatment services. Because low- and moderate-income families may have greater difficulty negotiating the cochlear implant process, EI can facilitate full access to this intervention by those with fewer financial resources.

The Classroom Acoustical Environment and the Americans With Disabilities Act.

Audiologists and acoustical engineers have urged that acoustics be considered in the design of classrooms for more than 30 years. Research has demonstrated that children with hearing loss have great difficulty understanding speech in noisy, reverberant environments. However, there has never been a legal mechanism to require local educational systems to address acoustics in the design and construction of schools. An effort by a broad-based coalition of engineers, audiologists, parents, architects, and educators is now underway to develop a standard for acoustics that would then be referenced in the Americans with Disabilities Act (ADA). Although the legal mechanism for this action is to address the needs of children with disabilities as the ADA requires (most notably, children with hearing impairments, but also those with central auditory disorders, attention deficit disorders, and vision impairments), the impact will be more far-reaching. All children-whether or not they have a disability-will benefit from a favorable acoustical environment.