Policies and practices outside of the hearing health care system can have a substantial influence on that system. Five speakers at the workshop described the effects of three such outside influences: health goals established for the American people, changes in the health care system in general, and research being pursued by the National Institute on Deafness and Other Communication Disorders (NIDCD) of the National Institutes of Health (NIH).
Howard J. Hoffman NIDCD/NIH
The Healthy People initiative was designed not as a federal initiative but as a national one with participation from nongovernmental organizations, state health agencies, professional associations, academic researchers, multiple federal agencies, and state and local stakeholders, said Howard Hoffman, director of the Epidemiology and Statistics Program at NIDCD/NIH. As Green and Fielding (2012, p. 451) observed, “The quantified objectives at the center of the initiative were a product of continuous balancing of changing science and political or social concerns and priorities along with national and state or special population needs.”
In 1979 the first Healthy People plan was drafted on the basis of a surgeon general’s report (DHEW, 1979) and an IOM report (IOM, 1978) urging a redirection of health policy toward prevention and health promo-
tion. That plan had five objectives for the year 1990 in health promotion, five in health protection, and five in preventive health services. Since then, the number of objectives has steadily grown; the plan for 2020 includes 42 topic areas, each of which has numerous objectives.
One change for 2020 is that hearing has been separated from vision. Still, the National Health Interview Survey has been asking questions about hearing since 1990, and the number of hearing questions has expanded over that period. For example, the 2002 survey asked, “What was the MAIN cause of your hearing loss or deafness?” Responses were as follows: present at birth (3.1 percent), ear infections or other infections (8.1 percent), ear injury or surgery (3.1 percent), brief loud sound (10.3 percent), noise exposure (25.3 percent), aging (29.9 percent), some other cause (10.7 percent), and don’t know cause (8.8 percent). The National Health and Nutrition Examination Survey (NHANES) has also included questions about hearing in the past, though the most recent survey focused on taste and smell rather than hearing. Together, these data sources have produced national estimates and age-specific prevalences of hearing loss, tinnitus, hearing exams, use of hearing protection, and use of hearing aids. These surveys have also produced information about comorbidities and risk factors for hearing loss.
In the area of “hearing and other sensory or communications disorders,” the Healthy People 2020 objectives include goals in not just hearing but newborn hearing screening; ear infections; tinnitus; balance and dizziness; and voice, speech, and language. For example, one goal is to “increase the proportion of persons with hearing impairments who have ever used a hearing aid or assistive listening devices or who have cochlear implants,” with subgoals for particular age groups and technologies. The subgoals call for improvements of only 10 percent by 2020 over a baseline amount, noted Hoffman. “They are not meant to be unreachable targets. They are meant to be something that could be achieved.” Similar goals cover hearing examinations, the use of hearing aids, cochlear implant surgeries, newborn screening, and other areas of hearing health care. Some of the goals have “taken off,” Hoffman said—for example, almost all infants now receive a hearing screening during the first year of life—whereas others have met with slower change.
The Healthy People program is ambitious, Hoffman acknowledged. But it provides a national focus while also establishing objective and quantifiable goals that are useful at the state and local levels. The Healthy People tracking charts and tables provide a quick summary of progress for objectives showing improvement (or lack of improvement) over time and by key demographic groups, including race or ethnicity, education, income, gender, geography, and disability status. The data are also useful in monitoring and improving hearing outcomes for older adults, Hoffman noted. For example, tracking of hearing aid use shows gradual improvement from 2001 to 2012
for adults more than 70 years of age. “Are there strategies that can accelerate this trend?” he asked.
Robert Burkard University at Buffalo
The Patient Protection and Affordable Care Act1 (ACA) heralds major changes in the health care landscape, said Robert Burkard, professor and chair of the Department of Rehabilitation Science at the University at Buffalo. Multiple organizations have recommended moving away from a fee-for-service model and replacing it with value-based purchasing. The fee-for-service model encourages increased utilization, and more services result in more payment. “We have to get away from the assumption that more services are better outcomes,” said Burkard. “We have to get into the game of how we optimize value in health care.”
The biggest potential impact will be working to identify procedure groups to bundle, such as such as bundling of the current procedural terminology (CPT) codes for audiometric, acoustic immittance, and vestibular testing. With tests done together more than half the time, there is a bundle code, and physicians charge for that. They are paid less for a bundled code than for individual codes, however. The bundling of services for CPT codes probably will continue, Burkard predicted. In effect, this practice results in paying for a group of diagnostic procedures with a single payment, where the group of procedures produces both diagnostic and functional information.
Burkard also talked about the unbundling of hearing aids. Many patients ask why hearing aids are so expensive. In fact, the price usually includes many services, including taking the earmold, assessment, repair, earwax removal, counseling, and aural rehabilitation. Online and other hearing aid sales typically provide the device but not the above-listed services, making the devices substantially cheaper than when the hearing aid is bundled with services. Practices need to have a plan for how to work with patients who have purchased their hearing aids elsewhere, he said. Burkard asserted that under Medicare, if you do not charge one patient for a specific service, you cannot charge another patient for that same service. Therefore, he said, unless one unbundles, any service a practice gives away, or appears to give away, that might be billable to Medicare must be done for free for all patients. “You have to either not charge anybody,” he said,
1 Patient Protection and Affordable Care Act, Public Law 148, 111th Cong., 2nd sess. (March 23, 2010).
“which I don’t think is saying much about the value of the service, or you have to charge everyone.” Thus, he concluded, if a patient buys a hearing aid online and then asks a specialist who provides any free hearing services to hearing aid patients, that specialist might be obligated to do so.
Another aspect of the changing hearing health care landscape is the transition to ICD-10 coding. The ninth revision of the International Classification of Diseases (ICD) had about 18,000 codes, while ICD-10 has about 160,000. This provides much more specificity, but the way hearing is coded in ICD-10 “still needs work,” said Burkard. ICD-10 could also be used with the International Classification of Functioning, Disability, and Health (ICF) to code levels of hearing loss severity, from zero for no problem to four for a complete problem, which provides a much broader framework to talk about the consequences of hearing loss.
The Physician Quality Reporting System was designed by CMS to improve the quality of care for Medicare beneficiaries. The ACA includes a transition from incentives for participation to penalties for nonparticipation. Still, there are currently few measures specific to audiology. The Audiology Quality Consortium, which consists of ten audiology organizations, is currently drafting measures for use—speech-in-noise testing for cochlear implant referral, functional communication ability, tinnitus screening and evaluation, ototoxic baseline measurement and monitoring, and vestibular testing—and is considering more.
The ACA describes 10 essential health benefits to be covered by health insurance exchanges and Medicaid. But the only benefits even partly related to hearing are in two categories: (1) rehabilitative and habilitative services and devices and (2) prevention and wellness services. If hearing services are not included as an essential health benefit, it seems unlikely that most accountable care organizations will include them, said Burkard. “We need to make our hearing services essential,” he said. “We need evidence that what we do makes a significant difference in outcomes.”
Burkard pointed out that the various professional organizations representing audiologists do not agree on the various legislative approaches for enhancing the ability of audiologists to provide optimal services. The American Academy of Audiology supports direct access, he said, whereas the American Speech-Language-Hearing Association supports comprehensive Medicare coverage of audiology services, which would allow audiologists to be reimbursed by Medicare for treatment services. The Academy of Doctors of Audiology supports limited license physician status for audiologists, direct access, and expanded audiology benefits under Medicare.
Audiologists and otolaryngologists do not always cooperate, Burkard observed. Despite evidence that audiologists are able to diagnose hearing conditions associated with significant morbidity and mortality (and thus
make appropriate medical referrals), opposition is strong for direct access to audiology. The American Academy of Otolaryngology–Head and Neck Surgery strongly opposes direct access for audiology, he said. In light of this opposition, Burkard added, a bill promoting direct access for audiology (proposed by the American Academy of Audiology) is not likely to be supported. According to Burkard, “If we want to make it possible for more elders to live independently longer, to reduce medical noncompliance because those elders with hearing loss do not understand what their physician is telling them, and to improve their quality of life, we must support legislation that mandates that Medicare cover the costs of hearing aids and allow audiologists to be reimbursed for their rehabilitative services.”
Interprofessional education has been a hot topic for more than a decade, Burkard observed, and speech and hearing have been a focus of attention. But there is no clear evidence that interprofessional education leads to increased value in health care, especially in hearing services, he pointed out.
At the end of his presentation, Burkard listed several priority areas that he proposed needed research. First, he argued that the audiogram is not an optimal functional measure of hearing, so research is needed for better measures, including disability scales and speech-in-noise measures. Second, he recommended a move away from a diseased-based scale of hearing loss (e.g., the ICD-10) to a functional-based scale (e.g., ICF). Third, he recommended more research on the differential diagnosis of the many causes of sensorineural hearing loss. Fourth, he suggested that while correlational research (such as between hearing loss and dementia) is important, this approach does not demonstrate cause and effect; he added that findings to date do not mean that treatment of hearing loss will reduce rates of dementia, and therefore more data are needed to support the value of adult hearing loss screening. Fifth, Burkard argued that reimbursement by Medicare is seriously flawed, and a better valuation system for CPT codes is needed. Finally, he recommended studies on the value of direct access to audiologists and what happens to quality of care when audiologists are reimbursed by Medicare to provide rehabilitative services.
Amy M. Donahue, NIDCD/NIH Judy R. Dubno, Medical University of South Carolina Lucille B. Beck, U.S. Department of Veterans Affairs
In 2009 the NIDCD conducted a Research Working Group on Accessible and Affordable Hearing Healthcare for Adults with Mild to Moderate Hearing Loss. The working group looked at the hearing health care system
as whole from a public health perspective and with the goal of increasing the number of individuals receiving quality hearing health care. It developed a research agenda aimed at delivering effective, affordable, and deliverable hearing health care access and outcomes to those who need them. It also wanted those outcomes to be implementable and sustainable in clinical and community settings and to complement and supplement, not replace, current paradigms. Amy Donahue, deputy director of the Division of Scientific Programs at NIDCD; Judy Dubno, professor in the Department of Otolaryngology—Head and Neck Surgery at the Medical University of South Carolina in Charleston; and Lucille Beck, chief consultant for rehabilitation and prosthetic services in the Veterans Health Administration for the Department of Veterans Affairs, described the working group’s background and recommendations.
Working Group Background and Rationale
The working group focused on adults of all ages with mild to moderate hearing loss, not just older Americans. But mild to moderate hearing loss represents the hearing status of many older Americans, and they are least likely to have had a hearing screening assessment or use a hearing aid for one of many reasons. Yet early intervention may lead to better outcomes, Donahue noted. In addition, many of these individuals are still active in the workforce, and many will transition to severe hearing loss and need more complex interventions and services in later years.
Access is as important as affordability, she said. Today, there are no readily accessible, low-cost ways for U.S. adults to get their hearing screened. Instead, there are multiple entry points marked by competing interests, including family practitioners, audiologists, hearing aid specialists, and otolaryngologists. Also, obtaining a device through traditional delivery models is a multi-visit process, requiring a visit to a physician and a specialist in audiology. Direct-to-consumer marketing heretofore has been the primary source of low-cost hearing aids, available through the Internet, magazines, newspapers, but “consumer beware,” said Donahue. “We need better alternatives.”
According to Donahue, the average out-of-pocket cost of one hearing aid, including devices and services, is approximately $1,800. About 70 percent of people require two aids. The life span of hearing aids is approximately 4 to 6 years, after which replacement costs repeat the expense. Yet 35 percent of American households have an income of less than $35,000 per year, and the median household income in America is $50,000 per year. Different segments of the population likely have different price points, and there are limited scientific data on the specific impact of costs on adoption rates. But among nonadopters, cost is cited as the primary
reason for not getting a hearing aid. Two-thirds of these people said that they would get a hearing aid if insurance or other programs provided 100 percent coverage, and 47 percent said they were likely to get a hearing aid if the price did not exceed $500. “Beyond the purchase of a home or a car, hearing aids and services can be the third most expensive purchase for many Americans with hearing loss over time.” But hearing health care is not covered by Medicare or most insurance plans. Instead, people rely on Lions Clubs, loaner banks, and philanthropic organizations, which “is not an acceptable public health solution.”
One of NIH’s missions is to close gaps in health disparities, including those among racial and ethnic minorities, the urban and rural poor, and the medically underserved. Acquiring hearing health care may be especially challenging for the working poor. “It is important that we remain conscious of the underserved and the economically less advantaged,” said Donahue.
Donahue elaborated on rapid changes in new and emerging technologies (e.g., automated assessment and hearing aid fitting, smartphone capabilities) as well as changing service delivery paradigms that offer potential for making hearing health care more accessible and affordable. She also provided information on the professional tensions among hearing health care providers and their lack of agreement on legislative strategies to address hearing health care.
Prioritized Recommendations of the NIDCD Research Working Group
The research recommendations focused on current and evolving technologies and strategies that are effective, accessible, and affordable; that reflect the demographics and socioeconomic capacities of the U.S. population; and that are practical and feasible for the near future. The members of the working group selected their highest-priority recommendations from a list of more than 70 recommendations. These were organized into 10 different areas:
- Hearing aid technologies
- Patient variables
- Aftercare needs
- Delivery systems
- Workforce and training of hearing health care professionals
- Medical evaluation and regulatory issues
- Overarching topics
Donahue did not go through all the recommendations at the workshop, but she provided an overview of several of the most important. First, an overarching research recommendation of the working group is to understand the benefits of hearing health care for general health, economic health, lifestyle, well-being, and family life. In the area of access, a better understanding is needed of such variables as complexity of services, costs, insurance and subsidies, location, and referral networks, she said. At the same time, patient-centered variables need to be studied, including needs and concerns, values, socioeconomic status, attitudes, stigma, and culture.
Barriers to hearing screening need to be evaluated, said Donahue, including availability, cost, insurance coverage, referral patterns, and the effect of health care settings. The best screening methods need to be determined in terms of sensitivity, specificity, follow-up rates, and long-term benefits to hearing health. Accessible screening paradigms are needed for emerging technologies and target populations.
In the area of assessment, the quality and accuracy of audiometry needs to be determined in different health care settings using different means of delivery, Donahue continued. The necessary components of assessment batteries, including cognitive and psychosocial components, need to be determined to guide the fitting of hearing aids and other interventions.
Hearing aid technology variables that predict success and influence market penetration rates need to be identified, Donahue said, including the minimal level of technology needed to achieve success. The effectiveness of various technologies for various populations also needs to be determined. Patient variables that predict success and influence market penetration rates (such as motivation, perceived need, age, socioeconomic status, and culture) also need to be identified, she said.
A standard set of measures to determine the success of hearing health care and better determination of how and when to measure outcomes would benefit the field, she added. For aftercare needs, the information and patient education needed for various service delivery models should be explored, she said.
Innovative delivery systems, such as mHealth, could be used for hearing health care. There is a need to modify current models, both the system and the provider, to increase access and affordability. With such changes, the necessary knowledge, skills, and abilities of hearing health care providers should be determined, whether in a traditional or nontraditional setting.
Finally, under medical evaluation and regulatory issues, Donahue asked whether the FDA regulations provide protection for patients or whether they create a barrier for access, thereby delaying necessary intervention. Needed evidence includes the appropriate medical evaluation for using a hearing aid, the percentage opting for a medical waiver, the prevalence of
treatable causes of hearing loss in adults seeking hearing aids, and the ability of consumers to detect treatable hearing loss.
NIDCD widely distributed and discussed the working group’s report.2 It has also encouraged grant applications through both traditional and unique NIH funding mechanisms. Box 7-1 lists some of the grants active at the time of the IOM-NRC workshop.
Finally, Donahue listed some of the challenges and opportunities in hearing health care. The pool of clinician-researchers in audiology and otolaryngology is small, she said. Interest in hearing loss research among other relevant professions—including gerontology, primary care, family medicine, outcomes, health services, public health, and epidemiology—is limited. Finally, research conducted in communities in partnership with researchers, outside an academic medical center, has been limited.
“This [IOM-NRC] workshop is a real opportunity to encourage engagement of the larger research community in this endeavor,” said Donahue. “These research recommendations remain timely and important.” NIDCD has been able to maintain hearing health care as a priority research area despite tight funding, and support from NIDCD leadership, staff, and the institute’s advisory council remains strong. Funding applications grew from 4 in fiscal year 2011 and less than $1 million to 15 in fiscal year 2013 and more than $4 million. Finally, the Senate report language for the institute’s fiscal year 2013 appropriations says, “The Committee strongly urges NIDCD to support research grants that could lead to less expensive hearing aids, so such aids could become accessible and affordable to more people.”
During the discussion period, Margaret Wallhagen emphasized the difficulty of conducting community-based research and partnerships. Trying to conduct research in a clinical setting requires overcoming major barriers, such as time, privacy, and ongoing changes in the health care system. Yet these studies are essential to figure out what will work in a real-world setting. In response, Donahue pointed to innovative practice-based networks where a group of practitioners come together and agree to participate in research. They use streamlined processes for recruitment and institutional review board approvals while drawing on their own patient populations to contribute to the overall project. For example, the Creating Healthcare Excellence through Education and Research project at the Duke Clinical Research Institute is a practice-based network involving otolaryngology, audiology, and speech pathology. Another example cited was the Great
2 The report is available at http://www.nidcd.nih.gov/funding/programs/09HHC/Pages/summary.aspx (accessed February 28, 2014).
Research Projects on Hearing Health Care Being Funded by
NIDCD at the Time of the Workshop
Effectiveness of Basic and Premium Hearing Aid Features for Older Adults: Comparing the effectiveness of basic-level and premium-level hearing aids
Minimal Technologies for Hearing Aid Success in Older Adults: Relationship between technology level and real-world effectiveness using wireless smartphones as part of outcome measurement system
Efficacy of a Low-Cost Hearing Aid and Comparison of Service Delivery Models: Clinical trial including service-delivery model (current best practices and over-the-counter simulation) and purchase price (low and typical)
Ability of Consumers and Audiologists to Detect Ear Disease Prior to Hearing Aid Use: Evidence relevant to the FDA-required medical evaluation with waiver option
Reduction of Disparities in Access to Hearing Health Care on the U.S.-Mexico Border: Testing the effectiveness of an innovative community health worker intervention (Promotora), used for other chronic conditions, to expand hearing health care access among older adults facing health disparities
User-Centered Control of Hearing Aid Signal Processing—Allows users to select their desired signal processing parameter values on mobile devices that communicate wirelessly with hearing aids
Improvement of Amplification Outcomes in Noise by Self-Directed Hearing Aid Fitting: Self-fitting with wireless control of hearing aids to explore preferred settings in noise—allow users to custom fit algorithms for greater success in background noise in daily use
Primary Care Intervention Promoting Hearing Health Care Service Access and Use: Within a primary care setting, testing the effectiveness of three protocols on subsequent access to and use of hearing health care services
Community-Based Kiosks for Hearing Screening and Education: Within four community-based centers, testing the effectiveness of five hearing screening paradigms for hearing health care follow-up and hearing aid uptake
A National Screening Test for Hearing, Administered by Telephone: A U.S. version of a telephone-administered screening test that has been implemented in Australia, France, Germany, the Netherlands, and the United Kingdom
Wireless and Noise Attenuating Headset for Automatic Hearing Screening: Development of a mobile platform hearing screening device designed for use at point-of-care locations with limited personnel resources
Lakes Practice into Research Network, a primary care research network in Michigan.
Lucille Beck, who is the chief consultant for rehabilitation and prosthetics, as well as the chief of the audiology and speech language pathology services at the U.S. Department of Veterans Affairs, also pointed to funding through the VA for the Health Services Research Community, which looks at the context of service delivery in the real world. This interdisciplinary research is looking at cross-disciplinary teams of physicians, nurses, social workers, and community service workers all working on behalf of patients.