RE:  COMMENT ON EMERGENCY REGULATION ON CERUMEN MANAGEMENT

Introduction

My name is Leah Ball and I am a founding member of Richmond Hearing Doctors, PLLC.  I have been practicing audiology for more than 20 years, during which time I have practiced at two large academic medical centers, including Tripler Army Medical Center in Honolulu, Hawaii and, more recently, the University of Virginia Medical Center.  I have also practiced in a large, private otolaryngology practice in Richmond, and at three different private audiology practices, including my current practice at Richmond Hearing Doctors.   Throughout my career, I have seen audiologists throughout the country, including here in Virginia, provide cerumen management services to patients in need. 

I write to address the emergency regulations promulgated by the Board of Audiology and Speech-Language Pathology (“the Board”) governing the performance of cerumen management, and also the Board’s intent to promulgate permanent regulations.  The Academy of Doctors of Audiology, the American Academy of Audiology, and the American Speech-Language Hearing Association have unanimously defined the audiology scope of practice to include cerumen management.  To the extent the Commonwealth of Virginia and the Board have chosen to overtly recognize cerumen management as falling within the scope of practice for audiology, I applaud their actions.  Cerumen management is an essential skill in the practice of audiology.

Comments on Emergency Regulations

Unfortunately, two aspects of the emergency regulations are cause for concern.  The first is the definition of “limited cerumen management,” which limits audiologists to the removal of cerumen from the outer one-third of the external auditory canal.  This definition is unnecessarily restrictive.  When cerumen removal is necessary to diagnose, assess, or treat a hearing disorder, it is common for cerumen to exist throughout the full depth of the ear canal.  Provided the audiologist has the necessary training and experience – criteria that are validly defined by the Board – the audiologist should be given the professional discretion to perform the necessary cerumen removal.  There is no apparent clinical basis for limiting such removal to the outer one-third of the auditory canal, and doing so significantly increases the number of patients who must be referred to a physician for a service that falls well within the training and experience of many audiologists.  

The second and more troubling aspect of the emergency regulations is the expansive list of preexisting contraindications.  The list of contraindications includes categories of patients who frequently have the greatest need for cerumen management services, and will therefore suffer the greatest limitation in their access to care.  This includes diabetics, for whom hearing impairment is twice as common then in patients without diabetes.  It is not uncommon for an audiologist in private practice to see at least one patient a day who has diabetes, and yet the emergency regulations prohibit that audiologist from using even a small cerumen loop to remove wax during the patient’s quarterly hearing aid check-up. 

Admittedly, there are valid contraindications for cerumen removal, but trained audiologists recognize these conditions when they present themselves clinically.  For example, audiologists are well trained and understand that perforation of the tympanic membrane, or the presence of a myringotomy (PE) tubes, are universal contraindications for cerumen management by ear canal irrigation. When appropriate procedures are followed, including the referral of patients with very special needs, risks associated with cerumen management are negligible.   

The obligation to identify clinical indications, or contraindications, for a medical procedure is best left with the individual practitioner, rather than being defined by regulation.  Imagine for a moment that the practice of medicine were defined as including surgery, but only when the surgery is not contraindicated by a specific list of medical conditions.  Such an effort to define the scope of medical practice by reference to a defined list of contraindications would, in additional to being unworkable, would invariably deprive the physician of the professional discretion that is inherent in his or license to practice medicine, and consequently deprive the patient of the physician’s professional judgment.  The same is true for audiologists.  Audiologists who possess the education, training, and experience to engage in the practice audiology (and who are bound by a professional code of ethics and community standards of care) can best serve their patients when they are given the professional discretion to determine when a particular treatment or service is clinically indicated, including cerumen management.  

In short, the statutory directive that the Board “promulgate regulations governing cerumen management by audiologists, which shall include requirements related to training and qualifications of audiologists who perform cerumen management,” may be complied with fully by prescribing training and qualifications for audiologists who remove cerumen.  There is no statutory requirement for the Board to establish a narrow definition for “limited cerumen management” or to delineate specific contraindications for cerumen management, and I would urge the Board not to do so.  

Adverse Impact of Overly Restrictive Limitations

Implementation of the emergency regulations is already having, and will continue to have, an adverse impact on a large patient population.  The emergency regulations require all audiologists, even those with appropriate training and experience in cerumen removal, to refer large categories of patients (including, for example, patients whose tympanic membrane is not at least 25% visible, or who have hearing in only one hear, or who have diabetes) back to their primary care physician.  It is commonly known that physicians rarely remove cerumen themselves, but instead delegate the procedure to nurses who frequently have minimal training and experience, if any, in cerumen management.  In addition, it is uncommon for primary care physician practices to have the equipment necessary to provide cerumen management with gentle irrigation or gentle suction.  As a result, attempts to remove cerumen in primary care practices are often unsuccessful.  These physicians, many of whom have historically developed relationships with private audiology practices where the reputation for excellent care has been proven, are now forced to send a significant number of patients to an ear, nose, and throat (“ENT”) physician. 

In short, the emergency regulations have resulted in many patients being referred to primary care physicians who either cannot, or do not want to, provide cerumen management, and who must in turn refer those same patients to ENT physicians who are wondering why they must personally provide a service that was previously delegated to employed audiologists. 

Residents of nursing facilities and residential retirement communities find it even more difficult to receive treatment of cerumen impaction than the typical patients described above, and many; in fact, remain impacted even after a nurse attempts to remove the cerumen.  While primary care physicians routinely visit residents in nursing facilities, they rarely (if ever) provide cerumen management.    Historically, audiologists who hold clinic in nursing facilities and residential retirement communities have been available to provide cerumen management services to patients without the need for transportation out of the facility and at a fraction of the cost of a physician visit.  Pursuant to the emergency regulations, many of these patients (including those who suffer from diabetes, have hearing loss in one ear, or who have a total or near total impaction) will now have to be transported to a local ENT office.  When the time required for transportation, which must often be accomplished by van or bus, is combined with the typical wait at a busy ENT practice, many patients will now spend hours away from a medical care facility just to have ear wax removed, when previously they could have gotten the same service in a matter of minutes without leaving the facility. 

As the circumstances above illustrate, the emergency regulations have dramatically impacted the way in which patients receive cerumen management services in Virginia, without any clear benefit in quality of care or patient safety. 

Requested Action

For the reasons expressed, I request that the Board consider the following actions:

1.  Amend or revise the emergency regulations as soon as possible.  The legal authority to do so is contained in Virginia Code Section 2.2-4011.C., which states the following: “C. All emergency regulations shall be limited to no more than 18 months in duration. During the 18-month period, an agency may issue additional emergency regulations as needed addressing the subject matter of the initial emergency regulation, but any such additional emergency regulations shall not be effective beyond the 18-month period from the effective date of the initial emergency regulation.
2. Amend the definition of “limited cerumen management” in 18VAC30-20-10, as shown below. "Limited cerumen management" means the identification and removal of cerumen from the cartilaginous outer one-third portion of the external auditory canal in accordance with minimum standards and procedures set forth in this chapter.
3. Delete the list of preexisting contraindications listed in 18VAC30-20-241.C.  Audiologists would still be required to recognize the existence of contraindications that require referral to a physician, as stated in 18VAC30-20-241.B.1., but the deletion of subsection C would restore audiologists’ professional discretion to determine when a contraindication exists.

Thank you for your consideration of these comments.

Sincerely,

Leah D. Ball, Au.D. 

Richmond Hearing Doctors, PLLC