The American Academy of Audiology (the Academy), the Academy of Doctors of Audiology (ADA), and the American Speech-Language Hearing Association (ASHA) are together seeking changes in Medicare rules. The changes proposed will allow Medicare patients direct access to audiology services without a referral from a physician and would reclassify audiologists as practitioners. Classification as practitioners would allow audiologists to be recognized by Medicare (i.e., reimbursed by Medicare) for the full scope of their state-defined licensure law. Notably, the Medicare Audiologist Access and Service Act (MAASA) delivers a uniform message from audiology organizations to Capitol Hill for the pursuit of enhanced patient access to audiological care. 

MAASA would ensure that seniors and persons with disabilities on Medicare have access to a full range of hearing and balance health services provided by a licensed audiologist (see TABLE 1).

TABLE 1. Medicare Audiologist Access and Service Act (MAASA)

WHAT THE BILL WILL DO

WHAT THE BILL WOULD NOT DO

Adds a definition of “audiologist services” to Medicare. Authorizes audiologists to provide covered services that fall under their state scope of practice.*

Expand the audiology scope of practice*, e.g., allow for prescription or ordering rights.

Amends the Medicare definition of practitioner to include audiologists (similar to providers such as clinical social workers and clinical psychologists)

Change health benefits covered by Medicare such as inclusion of hearing aids.

Removes pre-treatment order requirement for audiology services.

Change Medicare provider status to physician or limited license physician at state level.

Allow audiologists to opt-out of the Medicare program.

 

 

The American Academy of Otolaryngology-Head Neck Surgery (AAO-HNS) opposes direct access and status change to practitioners within the Medicare program (www.entnet.org/content/scope-practice-issues). The AAO-HNS argues to the Centers for Medicare and Medicaid Services (CMS) and members of congress that direct access and practitioner status for audiologists would…

undermine the overall hearing health-care team…” and that “hearing and balance disorders are medical conditions that require a full patient history and physical examination by a medical doctor (MD) or doctor of osteopathic medicine (DO). Further, the AAO-HNS opposes any legislation that would allow audiologists to independently diagnose or treat medical conditions associated with hearing loss.

Let’s consider these concerns and other potential concerns voiced by our otolaryngology colleagues.

1. Undermine the Overall Hearing Health-Care Team

There is no evidence to support that direct access to audiology undermines hearing health care or increases risk for morbidity or mortality or missed diagnosis. The burden of proof is based on the preponderance of the evidence. 

In a 2010 Mayo Clinic study, audiology and otolaryngology investigators examined the safety of audiology direct access for Medicare patients complaining of hearing deficits (Zapala et al, 2010). The electronic medical records of 1,500 Medicare-aged patients were reviewed, including test results, impressions, and management plans from audiology and otolaryngology departments. Data revealed no discrepant treatment plans recommended by audiologists compared to otolaryngologists in more than 95 percent of the cases. Further, no case was associated with significant mortality or morbidity. According to an otolaryngologist investigator, in 78 percent of the cases, only audiology services were necessary. 

Outside of Medicare, many patients do have direct access to audiology, including our nation’s Veterans (since 1992), federal employees including members of the U.S. Senate through the federal employees health benefit plan, and many private insurance companies. No published data demonstrates that direct access to audiological services has any negative consequences for patient safety. Also, this legislation would not deny patients the option of seeing their physician first. 

2. Hearing and Balance Disorders Require Physical Exam by a Physician

Hearing loss and balance disorders are medical conditions that have been managed by audiologists for decades. However, the vast majority (>90 percent) of hearing loss in the Medicare population is sensorineural (SNHL) related to noise exposure and age-related factors (Hoffman et al, 2017). Of course, hearing loss is not inevitable, rather a person’s genetics, medications, health status, and lifestyle contribute to SNHL with age. 

Ear-related medical pathologies that are life threatening are low (see TABLE 2 from Zapala et al, 2010). Ultimately, the prevalence of such disorders is rare, which is why the Food and Drug Administration (FDA) in 2016 recommended removal of physician medical clearance for hearing aids. 

TABLE 2. Ear-Related Medical Pathologies

EAR PATHOLOGY

PREVALENCE

CASES/1,000,000

REFERENCE

Otitis Media

4.5%

44,989

Lin et al (2009)

Ménière’s Disease

0.19%      

1900

Alexander and Harris (2010)

Otosclerosis

0.06%

560

House and Cunningham, 2005

Sudden Hearing Loss

0.02%

200

Rauch (2008)

Vestibular Schwannoma

0.002%

17

Tos et al (2004); (Kshettry et al, 2015)

*Adapted from Zapala et al. (2010) and updated.

In taking this step, the FDA cited a report by the National Academies of Sciences, Engineering, and Medicine (2016) that concluded… 

after weighing the rareness of the medical conditions, the incidence of hearing loss in adults, the widespread need for hearing health care, and wide use of the medical waiver, there was no evidence that the required medical evaluation or waiver of that evaluation provides any clinically meaningful benefit. 

Concerns for medical pathologies such as a vestibular schwannoma (prevalence 0.002 percent or 17 per 1 million—Kshettry et al, 2015) or idiopathic sudden hearing loss (prevalence 0.02 percent or 200 per 1 million—Rauch, 2008) may be warranted, but the symptoms are commonly audiological in nature and well recognized by audiologists. 

For example, audiology standards of practice guidelines and training regarding sudden hearing loss dictate referral to an otolaryngologist/physician (ASHA, 2018; Academy, 2012). The treatment options for these rare events are limited. 

Yet, the new guideline on the management of sudden hearing loss published by the AAO-HNS indicates that commonly used steroid treatment is optional, as there is limited data for efficacy in randomized placebo-controlled trials (Chandrasekhar et al, 2019). 

The recommendation of a medical evaluation does not adequately recognize audiologists’ training in hearing and balance anatomy and physiology, pathophysiology, differential diagnostics, treatment, counseling, and clinical decision-making. 

Audiologists receive extensive didactic and clinical experience in recognizing the need for medical referral, including FDA and AAO-HNS referral recommendations (Steiger, 2005; Zapala, 2008; Zapala et al, 2010). Medical-referral consideration and competency is a required accreditation component for the Council of Academic Accreditation (CAA) and Accreditation Commission for Audiology Education (ACAE).

In contrast, most primary-care physicians (PCPs) complete a handful of lectures on hearing and balance anatomy/physiology, pathologies, and a possible two-week rotation or one-month clerkship in otolaryngology, if of interest for residency. 

PCPs do receive substantial training in general areas of medicine and see hearing and balance issues in other rotations, but specific training on hearing and balance is limited, which may relate to low referrals to audiologists and otolaryngologists for hearing complaints. 

Mahboubi et al (2018) reported that only 27 to 33 percent of patients with a complaint of hearing loss who visited physicians were referred to an audiologist or otolaryngologist. Other surveys reveal that only 14.6 percent of adults with hearing loss had a hearing screening performed by their PCP (e.g., tuning fork or whisper test) (Kochkin, 2009) and only one-fourth of PCPs were aware that cochlear implants can help restore or enable hearing in deaf children and adults (Wu et al, 2013). 

Of the approximately 10,500 practicing otolaryngologists in the United States, only a small portion have obtained board certification in otology/neurotology (Hughes et al, 2016; Gantz, 2018). The rarity of serious ear disorders and surgical treatments for ear disorders has resulted in a workforce analysis that suggests a 10 to 15 percent oversupply of neurotologists/otologists in the United States (Vrabec, 2013). 

Common and treatable ear complaints that do not require specialty training, such as otitis media, can be handled by most general otolaryngologists. Further, approximately 30 million Americans over 60 years of age have hearing loss (Goman and Lin, 2016) that is not medically treatable; this corresponds to nearly 70 percent of the 44 million Medicare beneficiaries. Patient safety is paramount, but so is patient burden, time, and cost. Others have highlighted that the need for an unnecessary physician visit for referral to audiology also has significant cost implications (Freeman and Windmill, 2018).

Lack of medical concerns for hearing loss and greater concern for untreated loss led to the passage of the Over-the-Counter (OTC) Hearing Aid Act of 2017, signed by the president on August 18, 2017. The OTC act requires the FDA to create and regulate a category of OTC hearing aids for adults with self-diagnosed mild-to-moderate hearing loss. So, you can go to Walmart to purchase hearing aids, but Medicare will not pay for you to see a graduate-trained audiologist for evaluation and management without a medical referral?

Direct access to audiologists is well supported by advanced audiology training, limited medical ear pathologies, minimal risks for compromised patient safety, inconsistent referrals from PCPs to audiologists or otolaryngologists for hearing-related complaints, and recognized cost savings.

Note: This is not meant to undermine the rigor of training and importance of our otolaryngology and PCP colleagues. When surgery for treatable ear disease is an option, otolaryngologists are incredible assets to the hearing and balance team. PCPs serve a critical role in health maintenance. However, the prevalence of medically treatable ear disease is very low compared to the very large population of persons with non-medically treatable SNHL. Direct access to audiology poses minimal risk and a more direct pathway to otolaryngology when needed. 

3. AAO-HNS Opposes Legislation That Would Allow Audiologists to Independently Diagnose or Treat Medical Conditions Associated with Hearing Loss

The proposed legislation does not provide any expanded scope of practice, such as pharmacological or surgical treatment for ear disorders or pathologies. Audiologists will simply be able to provide diagnostics for hearing and balance disorders, recommend non-medical treatment for these disorders (e.g., hearing aids, assistive listening devices, training, and follow-up), and make physician referrals when medically necessary. 

The opposition to independently diagnose is a null point because, under our scope of practice, audiologists can already provide independent diagnosis of hearing loss and balance dysfunction and receive reimbursement by third-party payers including Medicare. 

MAASA would not expand the audiology scope of practice or allow audiologists to independently diagnose or treat medical conditions outside our already state-defined scope of practice. Further, audiologists are not seeking designation as a physician. The legislation would recognize audiologists as practitioners consistent with nurse practitioners, clinical psychologists, and clinical social workers, and consistent with the audiology academic and clinical training. 

Can audiologists handle such a responsibility? Yes. Audiologists already directly serve privately insured, federally insured, out-of-pocket, and Veterans Affairs patients. The literature supports that audiologists are trained to recognize necessary medical referrals. Even the FDA recognizes that delayed treatment of hearing loss with amplification and other audiological intervention outweighs the risk of missing life-threatening, ear-related disease. In addition, since 2008, CMS has already assigned audiologists the responsibility of determining medical necessity of diagnostic testing for Medicare beneficiaries.

In the United Kingdom, adult patients have direct access to audiology for hearing complaints in lieu of requiring otolaryngology referral. This pathway is well-supported in the literature. Two studies examined audiologist referrals for magnetic resonance imaging (MRI) to rule out retrocochlear pathology in cases of asymmetrical hearing loss and in tinnitus (Dawe et al, 2017; Fraser et al,2015). 

In these studies, audiologists streamlined the identification of retrocochlear pathology without compromised safety or efficacy. Similar results were observed with tinnitus patients who were referred directly to audiology (Davis et al, 2012). 

In the United Kingdom, the majority of patients are referred by general practitioners with strict guidelines for otolaryngology referrals. Nonetheless, the U.K. system shows, that for most patients, audiologists can recognize red-flag symptoms (TABLE 3) and audiologists make appropriate medical referrals. 

TABLE 3. Red Flags for Referral to Physician

RED FLAGS

Perforation of eardrum or discharge/infection

Ear pain 

Ear trauma or deformity

Sudden or rapid onset of hearing loss or aural fullness

Pulsatile tinnitus/myoclonic tinnitus/concerning unilateral tinnitus

Vertigo or significant history of falls

Conductive hearing loss, conductive pathology, or unexplained abnormal tympanometry

Significant asymmetrical hearing loss or asymmetrical speech recognition

Progressive or fluctuating hearing loss

History of ear-related disease or genetic condition

Concern for other medical pathologies: facial asymmetry, numbness, ataxic gait, headaches/migraine, difficulty speaking/swallowing, other dizziness, diplopia, and other neural deficits/concerns

Advantage Otolaryngology

Otolaryngology colleagues might benefit from patient direct access to audiology. Most hearing and balance complaints are not medically treatable. For example, cochlear implants (CIs) are reserved for populations with severe to profound hearing loss; however, less than 1 percent of older adults meet CI candidacy guidelines (Lin et al, 2012). Even so, prior to implantation, many insurance companies require a trial period with traditional amplification. 

Otolaryngologists are highly trained in performing surgeries and managing complex cases. Managing patients with gradual onset of untreatable SNHL and tinnitus is not effective use of their expertise. Streamlined practices, with direct access to audiology, could lead to cost savings for the patient and potentially improved practice and availability for otolaryngologists to perform surgery and higher-level services.

Conclusion

Otolaryngologists and audiologists serve important roles in hearing and balance health care. The audiologists pursuit of direct-access and practitioner status is not an effort to expand their scope of practice or disrupt an otolaryngologist’s role in hearing and balance health care. 

The changes in the CMS definition of an audiologist would not allow audiologists to perform ear surgery or prescribe medications. The changes would simply allow patients direct access to audiology services without unnecessary burdens on the health-care system or the patient. Most hearing issues in the Medicare population are not medically treatable, go untreated, or eventually make their way to an audiologist after a series of referrals (a rationale for the FDA excluding the requirement for a medical waiver for hearing aids). 

Even at that point, the services provided by an audiologist, outside of diagnostic evaluation with physician referral, are not covered by Medicare. Ultimately, the only change MAASA would likely bring is improved access and coverage of non-medical care for hearing loss and balance complaints.