[MUSIC PLAYING] AMBER WILLINK: Hello, everyone. I'm Amber Willink, Faculty with the Johns Hopkins Cochlear Center for Hearing and Public Health, with a full academic appointment at the University of Sydney in Australia. I'm a health services researcher, by training, and have worked extensively in health policy in the US, Australia, and across East Asia, and the Pacific. In this lecture, we will be discussing hearing care policy and funding models, and how approaches to hearing care policy differ around the world. We'll be using a policy framework that considers the goals of a health care system, to consider these different approaches across workforce policy, device regulation, coverage, and reinvestment decisions. So in this lecture, we will focus on workforce policy and device regulation, coverage and reimbursement decisions, and, finally, we'll give some country case study examples. It's important when developing a policy to be clear on the goals of that policy, and to ensure that the various dimensions of the system are being considered. The broad goals of the health care system are to ensure access to necessary care, appropriate utilization of care, high quality of care, and affordable and reasonable costs of care. In this section, we'll be discussing workforce policy and device regulation as important components for hearing care policy. A helpful way to consider the workforce and device regulation decisions is through the goals of the health care system-- what impact do they have on individuals accessing care, the frequency that they use care, whether they are getting the right care for them, and whether it is affordable. Decisions on workforce policy can include-- who can provide that care? What is the scope of practice across the different providers? What are the training and licensure requirements? And where is that decision made? Is it at the state or province level, or at the national level? Is there a gatekeeper mechanism in place? By that, I mean, is there a referral that's required from the physician before accessing care from a hearing provider? These are many of the different decisions that need to be made regarding the workforce to support the delivery of hearing care. So let's think through some of these decisions and how they may impact on the goals of the health care system. I have a few examples here for you. A decision on who can provide care can affect the availability and accessibility of care. So, for example, if there is more flexibility in the types of providers that can offer hearing care, then there is likely to be more providers in different locations and settings that can facilitate access to care. The more restrictive the policy is on who can provide care, the more likely it is that access will be constrained, as well. Decisions on training and licensure requirements can also affect access to care, quality of care, and cost of care. The higher the level of training that is required, the fewer people are likely to apply to the program and graduate. Although, more training may result in better quality care. If providers need to recuperate the high costs of training, those costs will be ultimately transferred to the patient, increasing our overall costs of care. There are many instances across the health care system where a gatekeeping mechanism is in place. The rationale behind having to get a referral to a service is to ensure the care is necessary, which can improve the quality of care and keep the cost down, as it's only used when necessary. On the flip side, many people may delay seeking care, or go without care, due to this additional step they have to go through. This may be particularly the case if there are financial or physical barriers related to getting the referral, such as an additional co-payment, to see the first physician. This slide breaks down the workforce policy for hearing loss in the United States. There are a mix of providers in the US that can deliver hearing care services, including an ear, nose, and throat physician, an audiologist, and a hearing aid dispenser. The training requirements differ greatly across these providers. In the US, an audiologist is trained at a doctorate level that requires four years of full-time study. The licensing for audiologists is managed at the state level, which results in scope of practice differences across the different states. Finally, in the US, individuals must get a referral from a doctor before they have a hearing exam. In this slide, I'm showing two maps of the US, and these maps show the count of audiologists, on the left, and the audiologists per 100,000 people, on the right. These maps depict the large variation in the availability of audiologists across the US, which undoubtedly has an impact on access to hearing services. This study by Arrianna Planey, in 2019, showed that the supply of audiologists was lower in areas where the proportion of older adults with difficulty hearing was higher. It also showed that audiologists tended to be in counties with higher household incomes and younger populations. This slide shows two graphs looking at the relationship between per capita gross national income of a country, on the x-axis, and ear, nose, and throat specialists per million persons, on the y-axis-- in the top graph, labeled as Figure A-- and audiologist per million persons, on the y-axis of the bottom graph, labeled as Figure B. In the top graph, what appears to separate counties apart-- in both lower income and higher income groups-- is the role of government funding for ear, nose, and throat specialists. In countries that had higher government funding, there were more ENTs per million persons. That government funding is making specialist care more affordable to individuals, and increasing utilization of those services, which is therefore encouraging more doctors to pursue an ENT specialty. In the bottom graph, the difference in the number of audiologists only really differed across high income countries. The authors suggest the difference across these countries is whether the audiology program requires prior medical training or not. The countries that had high numbers of audiologist per million persons did not require pre-medical training. That additional training acts as a barrier for entry, reducing the number of graduating audiologists. Most countries included in this study reported having greater numbers of ear, nose, and throat specialists than audiologists, with 86% of countries reporting insufficient numbers of audiologists. The top five reasons given were lack of government funding, lack of professional awareness, lack of personal awareness, lack of training programs, and poor pay and conditions. Both of those slides are important insights into how workforce policy can impact on the goals of the health care system. The question then is, how could a hearing care workforce be designed to better meet the needs of the population? And is that model sustainable for providers? For example, many older adults have hearing loss. Many also have physical or functional limitations that make accessing care in a clinic difficult. Providing a workforce that has ties to the community, and can meet these high-need older adults where they are at home, would better meet the needs of older adults with hearing loss. There are questions as to how sustainable such a model is without public financing. Now, we will discuss hearing care policies as they pertain to device regulation. Device regulation addresses some of the following questions-- what can be sold, and how they're labeled. Where can the devices be sold, such as through an audiologist or hearing dispenser, or as a direct-to-consumer product? And finally, what are the marketing rules for the devices? Using the goals of the health care system to guide our thinking on these decisions, what devices can be sold, and how they are labeled, can impact on the number of competitors in the market. Generally, greater restrictions on the devices makes entering a market very difficult and costly. So fewer companies want to do it, and the price of the devices is determined by the few companies who hold the greater market share. If the market is more competitive, however, the price of the devices is likely to be lower, and may, therefore, be more accessible to individuals with hearing loss. Where the devices can be sold can impact on the accessibility of the devices. If it is limited to a clinical setting, then you're likely to miss those who do not engage often with the health care system. However, if you expand it to direct-to-consumer options, then the places they can be sold is greatly increased. So for example, in large retail settings, such as Costco or Walmart, or in pharmacies. And there are many more people who pass through these stores and would have access to devices. Ensuring the devices are appropriately marketed can ensure better quality of care and outcomes for individuals with hearing loss. Here's a list of the regulators for hearing devices across the United States, Australia, the United Kingdom, China, and Brazil. These organizations are responsible for making the decisions around what, where, and how devices can be sold. In 2017, there was a significant change to hearing device regulations in the United States. The Over-the-Counter Hearing Aid Act required the Food and Drug Administration to establish a regulatory framework for the sale of over-the-counter hearing aids for perceived mild to moderate hearing loss. This policy change is expected to increase the number of companies in the hearing aid market, which will increase the access to regulated hearing aids, and lower their cost. [MUSIC CONTINUES]