HEARING VIEWS
Gael Hannan, Editor
Hearing Views discusses important issues that impact both audiology professionals and the people with hearing loss that they serve. Topics range from education and advocacy to industry, technology and the client-professional relationship, and more. Comment Policy

by Mike Metz

 

A renowned and respected otologist told me over 25 years ago that if I was not billing insurers with the “unlisted procedure” code (a “by report” code for reimbursement), I was not on the leading edge of my profession.   Good advice at a time when the field was moving forward.

Not like these days.

In a private audiology office, what are the consequences if a clinician does not adhere to best clinical practices because tests are not reimbursed sufficiently?  Does he/she proceed with necessary procedures knowing they won’t be paid?  Does it make a difference if the patient is covered by a “conventional” insurance plan (balance billing?) versus a Medicare plan?

In an audiology office, with patients seen for investigative testing upon referral, the assumption is that neither a history nor a report is necessary, as these tasks fall back to the referring physician.  Hence, the billing allowed the audiologist consists of only a “technical” fee, and these are pretty low.

If the physician refers for complete diagnostic testing within the scope of audiology, a series of within-scope-of-practice tests are in order, the methods and interpretation of which may not have been “in the book” of most physicians.  In these cases, a review, an addition to the history, and a report are necessary for proper management of the patient’s audio/vestibular problem.  Many tasks associated with the procedures are not reimbursable (irrespective of value).

On May 5th of this year, Barry Freeman posted a treatise about professional concerns on the Audiology Academy website discussion board.  Of particular interest was his discussion of the Ethics of Weakness and audiology functioning from that stance.  He concludes by saying,

Are we suffering from an ethics of weakness?  I certainly hope not but certainly the reports coming out of DC from groups like the IOM and PCAST are questioning the entire hearing care delivery system. Let’s prove to those that are watching us that we can make decisions that are in the best interests of our profession and people we serve.

What proof is required?

When issues of reimbursement conflict with professional ethics, which prevails: the professional scope or the legally expedient regulation?

The tragic answer is that the regulation won.  Audiology was ineffective in the efforts needed to change this.  Barry is correct. Audiologists and their organizations apparently decided that they could make up for the lack of reimbursable tests by abandoning the ethical practice stance and/or by bundling a few tests into the sale of hearing aids. In essence, the easier path was taken and investigative testing gave way to tossing a couple of quick diagnostic tests into a sales pitch. Physician offices like this system.  Dispensing audiologists like it too.

When called upon in court to defend audiologists who did not do all the tests necessary to fulfill their duty to a patient, the most successful argument has been that the audiologist was not legally qualified to make a diagnosis and therefore not really accountable for subsequent patient problems.  And that disqualification negates any audiology scope of practice.  It also disallows for responsibility to the patient, despite any degree or ethical code.

Audiologists did not pay sufficient attention to their scope of practice, specifically in terms of using tests that more specifically define problems, and then pursuing the tasks necessary to create sufficient justification and reimbursement.  If there is value in the hearing clinic, there is a need to assure a rational as well as a financial base for this value.  Now the field faces huge problems in that most investigative tests do not generate the level of reimbursement necessary for the maintenance of a professional practice.  Without device sales, there appears to be insufficient value in differential testing, to say nothing about rehabilitative procedures.

At this time in the short history of audiology, private practice is left with only retail sales to support its financial self.  Such cannot be the sole driver of future professional independence.

If healthcare’s primary responsibility is to the patient, and if this responsibility is dictated to a large degree by a scope of practice, the direction is obvious.  If regulations and billing restrictions prevail, then audiology can look forward to a future in which most financial reward comes not from professional abilities, but only from retail sales.

I think this dilemma and its side issues pose the largest problems to the profession.  And it seems to me that if audiology is to remain anything other than a retail source for hearing devices, its resolution should be at the top of the to-do list.

If you think that looking for help in these matters from other health professions will save us, see Part 2 to follow.

 

Michael Metz, PhD

Michael Metz, PhD

Dr. Metz has been a practicing audiologist for over 45 years, having taught in several university settings and,  in partnership with Bob Sandlin, providing continuing education for audiology and dispensing in California for over 3 decades.  Mike owned and operated a private practice in Southern California for over 30 years.  He has been professionally active in such areas as electric response testing, hearing conservation, hearing aid dispensing, and legal/ethical issues.  He continues to practice in a limited manner in Irvine, California.

Seven months have gone by since the publication of the President’s Council of Advisors on Science and Technology (PCAST) report on the ways that technology can help individuals with mild to moderate hearing loss.

PCAST

The PCAST report seemed to be the start of a series of activities designed to change the delivery of hearing health products. The report started the drumbeat to remove FDA regulatory restrictions of any kind on PSAP’s to allow them to be marketed to both hearing impaired and non-hearing impaired consumers.  PCAST also recommended that the FDA create a new category of OTC (over the counter) basic hearing aids.  The underlying concept is that consumers are capable of self-testing, self-diagnosing and self-treating hearing loss.  While PCAST limited its recommendations for opening the OTC market to those with self diagnosed mild to moderate hearing loss, others insisted that no matter what degree or severity of hearing loss existed, consumers should be allowed to choose self-diagnosing and treatment.

As audiologists, most of us were dismayed by the total absence of support or understanding of the professional services component.  In fact, the PCAST report included negative and erroneous comments about the role of audiologists in the delivery of hearing health services. PCAST misstated the average cost of hearing aids, stated that most audiologists limited consumers to one brand of hearing aid, suggested that audiologists’ recommendations were based on “distributorship agreements” and referred to hearing aids as “beige plastic devices.”

NASEM

Following the PCAST report, the National Academies of Sciences, Engineering and Medicine (NASEM) issued the report of its expert committee on the affordability and accessibility of hearing health care for adults. Mirroring the PCAST report, NASEM recommended that the FDA remove the regulation for a medical evaluation prior to hearing aid purchase. The NASEM report recommended three categories of devices: OTC “wearable hearing devices” designed for individuals with mild to moderate hearing loss, “hearing aids” for those with more severe hearing loss and PSAPs which would be intended for use by normal hearing individuals.  The wearable hearing device category would be exempt from many quality system regulations (QSR) and would have the option to include tests for self-assessment of mild to moderate hearing loss. NASEM also recommended the unbundling of professional services in the pricing of hearing aids.

FDA

As a result of the PCAST and pending NASEM reports, the FDA reopened the comment period on its 2013 Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products – Draft Guidance for Industry and Food and Drug Administration Staff.  The FDA asked for comments specific to key issues and recommendations identified in the PCAST reporting, including: “(1) The degree to which current FDA regulatory requirements may be acting as a barrier to hearing aid accessibility, affordability, and use of hearing aids; (2) the appropriateness of creating a “basic” category of hearing aids for consumers with “bilateral, gradual onset, mild-to-moderate age-related hearing loss” with appropriate labeling for over-the-counter sale; and (3) whether the benefits of expanded, over-the-counter access to hearing aids in this age-related hearing loss population outweigh the risks of forgoing the condition for sale (that the consumer may waive) that requires a medical evaluation to rule out treatable, potentially progressive causes of hearing loss.”

Comments to PCAST and the FDA generally fell into two camps – those believing that the FDA should continue to regulate hearing aids (AAA, ASHA, IHS, HIA, AAOO) and those who believed that accessibility and affordability were the most important factors (Consumer Technology Association (CTA), AARP and HLAA).  Some recommended that the FDA go beyond the PCAST recommendations.

Writing on behalf of the Bose Corporation, Diane Van Tasell and William Rabinowitz recommended that the “FDA should designate as a distinct category non-surgical, air conduction hearing aids, which may include wireless capability, intended to be sold directly to consumers. FDA should adopt distinct rules for such devices.” The Bose letter also recommended that all air-conduction hearing aids should be included in this OTC category, and that there should be no restrictions to certain categories of hearing loss.

CTA

It is important for audiologists to look at what may seem to be a new voice at the table in all of these deliberations.  The Consumer Technology Association (CTA) is a powerful and wealthy organization.  Take a look at this description of activities at the 2014 International CES convention.

“The game changing quality of high-resolution audio will have benefits far beyond the audiophile community. Consumers with various degrees of hearing loss will also benefit, as better quality audio is incorporated into the products and services they use daily.

Many consumers—both with and without hearing loss—experience difficulty listening to another person nearby, understanding conversations in crowded rooms, understanding movie dialogue in a theater, listening to lectures in an otherwise quiet room, hearing the phone or doorbell ring, or with situations in which background noise might interfere with speech intelligibility. Any device, or combination of Innovate devices and software that helps someone hear better would benefit many consumers.

Consumers want access to affordable hearing assistance, and CE manufacturers want to provide such devices and can do so responsibly. Consumers should be trusted to make decisions about their hearing assistance, just as they do with vision assistance in the over-the-counter eyeglasses market. Amplifying speech so that it is audible, and thus more intelligible, is not a feature reserved solely for hearing aids. A host of devices called Personal Sound Amplification Products (PSAPs) in the jargon of the U.S. Food and Drug Administration (FDA), provide many of the benefits associated with hearing aids.

The PSAP industry is mirroring the extraordinary innovation in the CE industry. Many PSAP devices are functionally equivalent to hearing aids in terms of sound reproduction and their ability to be tuned precisely, even by untrained consumers. PSAPs are also innovating; some, for example, use the built-in functions of smartphones to amplify environmental sound. A high quality directional microphone combined with a smartphone, an app that allows the user to set their preferences, and a good pair of ear phones can greatly improve many difficult hearing situations, without the need for a hearing aid.

People with hearing loss should be able to take advantage of the range of products and services that could improve their personal hearing environment. Not all Americans with hearing loss must be treated with hearing aids. For these people, a larger market of more readily available solutions will be enough. The FDA should engage in further dialog with the PSAP industry and hearing-disabled consumers to ensure a vibrant marketplace of products and services that provide solutions for all levels of hearing and hearing loss.

Demographic studies show the increasing senior population will drive the market for assistive services. A vibrant marketplace for PSAPs will support long term health care goals.

To ensure wide adoption, standards bodies such as CEA (now CTA) must address key issues including barriers to accessibility and usability, interoperability and personalization. There will likely be a need for further industry-led, voluntary standards to address enhanced accessibility issues while also addressing public policy goals. CEA (Now CTA) welcomes input from all stakeholders on standards areas to be explored.”

It is not hard to see whose opinion was mirrored in the recommendations of PCAST and NASEM.  More on the activities of CTA next time. In the meantime, I’d say buyer and audiologist beware.

 

Angela Loavenbruck, aka The Crabby Audiologist, has been in private practice since 1975. She has served as president of both the New York State Speech & Hearing Association and the American Academy of Audiology.  She was awarded the Joel Wernicke Award by the Academy of Dispensing AudiolAngela Loavenbruck, Hearing Health Mattersogy for her work on behalf of the AuD.  Angela has been Associate Professor at Teachers College, Columbia University and has spoken widely about ethics, private practice and accreditation standards. She and her husband recently celebrated their 50th wedding anniversary and have three children and three wonderful grandchildren.  Angela is also renowned for her Italian cooking and award-winning blueberry pie.