More from October 2014 – Vol. 33 No. 10
Eugene N. Myers, MD, FACS, FRCS, Edin (Hon)
Distinguished professor emeritus, University of Pittsburgh School of Medicine
It was a privilege to be invited to the sixth Baltic ENT Congress in Kaunas, the second largest city in Lithuania, May 22- 24 of this year. Ten years have passed since the Baltic ENT Congress was last in Lithuania.
The congress president, Prof. Virgilijus Ulozas, MD, head of the department of otolaryngology, Lithuanian University of Health Sciences, said, “This meeting will offer otolaryngologists from Lithuania, Latvia, Estonia, and other countries ideal opportunities to pursue continuing medical education, to learn about recent achievements and likely future developments, and exchange scientific ideas and experiences in our field.”
The organizers prepared a scientific feast with important foreign and national speakers. The meeting was in English. There were 283 registrants from 11 countries besides the Baltic States including
Australia, the Czech Republic, Denmark, Poland, South Korea, Turkey, the United Kingdom, and the United States.
There was strong support from four sponsors and nine exhibitors.
The excellent scientific sessions included 81 oral presentations in 10 scientific sessions, as well as 20 posters and a cochlear implant satellite symposium. I had the privilege of giving a keynote lecture on “The Changing Role of the Surgeon in the Management of Cancer of the Head and Neck”and chaired the panel on oncology. One of the program highlights was Prof. Ulozas’lecture titled “Intercellular Communication between Laryngeal Carcinoma Cells via Membranous Tunneling Nanotubes,”which provided new insights into the behavior of squamous cell carcinoma of the larynx at the cellular level.
The opening ceremony featured beautiful songs by the choir “Neres,”whose singers are from the Lithuania University of Health Sciences, Kaunas. An elaborate welcoming party followed in the Park Inn, and the last evening ended with a gala dinner at the Zalgiris Arena, the focal point for basketball in Kaunas. Interestingly, the favorite sport of the Lithuanian people, who tend to be rather tall, is basketball. In fact, many NBA players are from Lithuania.
All in all, it was a wonderful opportunity to visit Lithuania for the first time, learning from Lithuanian doctors about their country and about interesting scientific facts. For those who have not visited Lithuania, I can highly recommend it. Jeffrey B. Watson, MD, University of California, San Diego, Humanitarian Travel Grant Awardee
In October 2013, I had the privilege of joining a team of facial plastic surgeons to help the people of Quetzaltenango, Guatemala, on a medical mission sponsored by the AAFPRS FACE TO FACE and FINN Foundations. The team was led by J. Charlie Finn, MD, accompanied by Russell Kridel, MD; Scott Stephan, MD; Ryan Brown, MD; Vanderbilt resident Ross Shockley, MD; and a support staff.
We journeyed through Guatemala’s mountainous terrain, climbing through the beautiful city of Antigua to our final destination of Quetzaltenango. Situated 7,655 feet above sea level, Quetzaltenango is in a mountain valley with numerous small villages surrounding it. Despite the natural beauty and tremendous biodiversity that is evident all throughout Guatemala, it remains one of the poorest countries in Latin America. The local Quiche and Ladino people of Quetzaltenango tragically remain plagued by poor access to medical and surgical care.
Dozens of patients and their families had gathered at the Sanatorio Senda de Vida Clinic and we saw 110 patients the first day with a wide range of pathology including microtia, cleft lip and palate, craniofacial anomalies, nasal deformities, and scar contractures from burns and trauma. Numerous patients were also seen in follow-up who had received care from the team the year prior. In total, we performed 42 reconstructive surgeries during the following four days, addressing the diverse needs of our patients
The opportunity to work with this dedicated team of surgeons has reaffirmed my lifelong commitment to serve the less fortunate and I look forward to returning to Quetzaltenango this month to continue our mission. I am greatly indebted to the AAO-HNSF Humanitarian Efforts Committee for their support that made my participation possible. Kevin A. Peng, MD
Resident Physician, department of head and neck surgery, University of California, Los Angeles (UCLA)
The Yerevan airport felt much like any other, except that the line to clear immigrations and customs was blissfully short. I was greeted by Salpy Akaragian, RN, MN, FIAN, a UCLA nursing administrator who, along with Akira Ishiyama, MD, the senior neurotologist at UCLA, spearheaded the first efforts to bring cochlear implantation and advanced otologic care to Armenia in late August and early September of last year.
In its current incarnation, the Republic Armenia is young—22 years old. Its capital, Yerevan, is a refreshing mix of new and old.
We woke at 5:30 am and after breakfast, were whisked to Erebuni Medical Center, where our patients were waiting. As they were taken to the operating room, we consulted on a string of otologic patients: otosclerosis, deafness, after neonatal meningitis, and EVA syndrome.
Dr. Ishiyama scrubbed to supervise and assist Artur Shukuryan, MD, chair of the department of otorhinolaryngology at the Yerevan State Medical University (YSMU), as well as Vigen Bakhshinyan, MD, a former YSMU resident. Some things were familiar: the scrubbing, the draping, and the hair clipping. Others were not: the plastic microscope drape was washed between cases and reused. Instrument sterilization occurred on a small back burner in the kitchen area of the operating suite, right next to the electric coffeepot.
We initially performed two cochlear implants. The following day, three cochlear implant devices and two bone-anchored hearing (BAHA) devices finally cleared customs, and we rushed to the hospital. The patients, who had been on-call for surgery pending delivery of the devices, arrived before us. Drs. Ishiyama and Bakhshinyan performed cochlear implants, while I performed BAHA implants with the assistance of Dr. Shukuryan. These were the first two BAHA devices ever implanted in Armenia. I left postoperative care instructions for the three audiologists, who had been trained in Moscow and had previous experience with the BAHA system.
The trip made several lasting impressions. Although the facilities were relatively antiquated and the resources generally limited, they were sufficient to provide state-of-the-art otologic care. The camaraderie between patients’families and the physicians was impressive—all were on a first-name basis, even with the chair of the department! Finally, the devotion the patients’families displayed was truly remarkable. We are appreciative of all the work of the Nominating Committee to present the membership with the outstanding slate of candidates from which to choose. This is an important and difficult task with which it is charged, particularly when drawing from such an incredibly talented pool of Members. It deserves our recognition and appreciation. Members of the Committee are: Drs. James Netterville (chair), Peter Abramson, Ellen Deutsch, Howard Francis, Gady Har-El, Brian Nussenbaum, Shannon Pryor, Cecelia Schmalbach, Ashley Wackym, and Ken Yanagisawa. Lauren Zaretsky, MD, chair of the Ethics Committee serves as an ex-officio member of the committee.
We also extend our greatest appreciation to all the candidates for their willingness to run for office and serve the AAO-HNS and its members. You are all dedicated members and you are greatly appreciated.
Sujana S. Chandrasekhar, MD
Scott P. Stringer, MD, MS
Carol R. Bradford, MD
Jay S. Youngerman, MD
Kenneth W. Altman, MD, PhD
Stacey L. Ishman, MD, MPH
Albert L. Merati, MD
Brian A. Moore, MD
Lawrence M. Simon, MD Mark K. Wax, MD
Lifelong learning is a fundamental part of being a good physician. From the start of our education we seek the best way to improve patient care. Upon entering medical school, we see that in order to keep up with the rapid expansion of medical knowledge, a good set of learning skills will be necessary, if we wish to provide the best care to our patients. It is estimated that knowledge in medicine doubles every eight years. While some of this is at a basic science level that could one day offer insights and improved understanding of diseases, some immediately influence the care we offer. Addressing the question of how to keep up with this expansion of knowledge has many facets. The AAO-HNSF addresses the issue of lifelong learning in a number ways.
Whether it is by online education activities or at national meetings, a fundamental part of learning is to measure how that knowledge has been absorbed and understood. This is usually done through a series of pre- and post-tests. As part of this process of evaluating knowledge, competence, and performance, the Foundation has developed a healthy question bank. In fact, these questions are used for a multitude of education purposes. While they are most often used to test for acquired knowledge from an academic exercise, they can also be used to detect weakness in competence and provide a direction for future study.
An interesting side benefit is that the process of developing questions is a learning exercise in itself. In order to develop an effective question, the developers must be familiar with the subject. They must not only have the correct knowledge, but also be aware of subtleties of incorrect information that separates the individual who has learned and understands the material from someone who has not. They must evaluate current literature and look for biases in reporting. All questions require a reference and a justification for why the correct choice is, in fact, correct. Questions are developed in many forums. One of the earliest of these was the Academic Bowl. This competition takes place at the Annual Meeting & OTO EXPOSM. Four teams of residents are chosen from residency programs around the country that participate in the Home Study Course (HSC). Those programs with the highest performers are chosen and they then compete for a variety of prizes.
There are eight committees of more than 230 members that contribute to writing these questions. They develop questions for a variety of other education products also: Home Study Course, Online Courses and Lectures, and AcademyQ™. Questions are vetted through subject matter experts and then double-checked with committee chairs. The creation of a good question turns out to be an excellent education experience for not only the individuals testing their knowledge, but for a larger group of individuals involved in the process. Collection of the questions also allows the Academy to have a robust and constantly updated bank for members to use for professional development.
Question development is one avenue of lifelong learning that benefits many. Just in time learning is projected to be the wave of the future and this is a method of preparing for that future. Scott E. Brietzke, MD, MPH; Jennifer J. Shin, MD, SM; Sukgi Choi, MD; Jivianne T. Lee, MD; Sanjay R. Parikh, MD; Maria Pena, MD; Jeremy D. Prager, MD; Hassan Ramadan, MD; Maria Veling, MD; Maureen Corrigan; Richard M. Rosenfeld, MD, MPH
This month, the AAO-HNSF publishes its latest clinical consensus statement on Pediatric Chronic Rhinosinusitis in Otolaryngology–Head and Neck Surgery. Pediatric chronic rhinosinusitis (PCRS) is a commonly encountered condition in otolaryngological practice. Five percent to 13 percent of childhood viral upper respiratory tract infections may progress to acute rhinosinusitis,1-4 with a proportion of these progressing to a chronic condition. PCRS may also co-exist and/or be exacerbated by other widespread conditions such as allergic rhinitis and adenoid disease,5-9 and some suggest the incidence of PCRS may be rising.10 In addition, PCRS has a meaningful influence on quality of life,11 with its related adverse effects potentially exceeding that of chronic respiratory and arthritic disease.12 PRCS also has the potential to exacerbate asthma,13, 14 a condition which negatively affects 2 percent to 20 percent of children.15-17
In spite of its prevalence and influence on affected families, many aspects of PCRS remain ill defined. Nonetheless, PCRS occurs with sufficient frequency that otolaryngologists regularly encounter it in their practice, creating opportunities for optimizing practice patterns. While experience regarding the epidemiology, diagnosis, and management of PCRS is burgeoning, the associated evidence regarding optimal medical and surgical management has clear limits.
The AAO-HNSF Guidelines Task Force therefore, selected this topic for clinical consensus statement (CCS) development. The expert panel convened with the objectives of addressing opportunities to promote appropriate care, reduce inappropriate variations in care, and educate and empower clinicians and patients toward the optimal management of PCRS. The final document describes the result of this process, and focuses on diagnosis, medical therapy, and surgical interventions.
This consensus statement was developed using a modified Delphi method, a systematic approach to achieving consensus among a panel of topic experts. Initially designed by the RAND Corporation to better utilize group information in the 1950s, this methodology has been modified to accommodate advances in technology and is used widely to address evidence gaps in medicine and improve patient care without face-to-face interaction.18,19
Thirty-eight clinical statements were developed for assessment with the Delphi survey method. After two iterations of the Delphi survey, 22 statements (58 percent) met the standardized definition for consensus. Twelve clinical statements (31 percent) did not meet the criteria for consensus. Four clinical statements (11 percent) were omitted due to redundancy. The clinical statements were organized into four specific subject areas:
Definition and diagnosis of PCRS
Medical treatment of PCRS
Endoscopic sinus surgery/turbinoplasty.
For the full listing of clinical statements, see the full text of the consensus statement at http://oto.sagepub.com/.
Clinical practice guideline: management of sinusitis. Pediatrics. 2001;108:798-808.
Aitken M, Taylor JA. Prevalence of clinical sinusitis in young children followed up by primary care pediatricians. Arch Pediatr Adolesc Med. 1998;152(3):244-248.
Ueda D, Yoto Y. The ten-day mark as a practical diagnostic approach for acute paranasal sinusitis in children. Pediatr Infect Dis J. 1996;15(7):576-579.
Wald ER, Guerra N, Byers C. Upper respiratory tract infections in young children: duration of and frequency of complications. Pediatrics. 1991;87(2):129-133.
Smart BA. The impact of allergic and nonallergic rhinitis on pediatric sinusitis. Cur Allergy Asthma Rep. 2006;6(3):221-227.
Marseglia GL, Pagella F, Klersy C, et al. The 10-day mark is a good way to diagnose not only acute rhinosinusitis but also adenoiditis, as confirmed by endoscopy. Int J Pediatr Otorhinolaryngol. 2007;71(4):581-583.
Tosca MA, Riccio AM, Marseglia GL, et al. Nasal endoscopy in asthmatic children: assessment of rhinosinusitis and adenoiditis incidence, correlations with cytology and microbiology. Clin Exp Allergy. 2001;31(4):609-615.
Lee D, Rosenfeld RM. Adenoid bacteriology and sinonasal symptoms in children. Otolaryngol Head Neck Surg. 1997;116(3):301-307.
Nguyen KL, Corbett ML, Garcia DP, et al. Chronic sinusitis among pediatric patients with chronic respiratory complaints. J Allergy Clin Immunol. 1993;92(6):824-830.
Kim HJ, Jung Cho M, Lee J-W, et al. The relationship between anatomic variations of paranasal sinuses and chronic sinusitis in children. Acta Otolaryngol. 2006;126(10):1067-1072.
Kay DJ, Rosenfeld RM. Quality of life for children with persistent sinonasal symptoms. Otolaryngol Head Neck Surg. 2003;128(1):17-26.
Cunningham JM, Chiu EJ, Landgraf JM, et al. The health impact of chronic recurrent rhinosinusitis in children. Arch Otolaryngol Head Neck Surg. 2000;126(11):1363-1368.
Smart BA, Slavin RG. Rhinosinusitis and pediatric asthma. Immunol Allergy Clin North Am. 2005;25(1):67-82.
Rachelefsky GS, Katz RM, Siegel SC. Chronic sinus disease with associated reactive airway disease in children. Pediatrics. 1984;73(4):526-529.
Larsson M, Hagerhed-Engman L, Sigsgaard T, et al. Incidence rates of asthma, rhinitis and eczema symptoms and influential factors in young children in Sweden. Acta Paediatr. 2008;97(9):1210-1215.
Ronmark E, Perzanowski M, Platts-Mills T, et al. Incidence rates and risk factors for asthma among school children: a 2-year follow-up report from the obstructive lung disease in Northern Sweden (OLIN) studies. RespirMed. 2002;96:1006-1013.
Ayres JG, Pansari S, Weller PH, et al. A high incidence of asthma and respiratory symptoms in 4-11 year old children. RespirMed. 1992;86(5):403-407.
Vonk Noordegraaf A, Huirne JA, Brolmann HA, van Mechelen W, Anema JR. Multidisciplinary convalescence recommendations after gynaecological surgery: a modified Delphi method among experts. BJOG. Dec 2011;118(13):1557-1567.
Dalkey NC. The Delphi Method: An Experimental Study of Group Opinion. Santa Monica: RAND Corporation;1969. RM-5888-PR. Anjum Khan, MD, MPH
Medical Officer, Division of Ophthalmic and Ear, Nose, and Throat Devices
Office of Device Evaluation, CDRH, FDA
Adjunct Clinical Associate Professor of Surgery, Uniformed Services University, Bethesda, MD
Marilyn Neder Flack, MA
Executive Director, AAMI Foundation at AAMI, Silver Spring, MD
Rahul Shah, MD, Associate Professor of Otolaryngology and Pediatrics, Children’s National Medical Center and George Washington University, Washington, DC; Member, ENT Device Advisory Panel, FDA
From the AAO-HNS Medical Devices and Drugs Committee
Committee Chair and Series Editor: Anand K. Devaiah, MD
Associate Professor, Departments of Otolaryngology, Neurological Surgery, and Ophthalmology
Boston University School of Medicine and Boston Medical Center
As scientific and technological advances enhance the pace of medical device1 innovation, there is increasing reliance on medical devices for patient care. Otolaryngologists, who may work in settings such as outpatient, emergency, surgical, and/or nursing home care, use a wide variety of devices for diagnosis, mitigation, and treatment of medical conditions for their patients.
The inaugural article in this series for the Bulletin introduced the basic concepts of how the Food and Drug Administration (FDA) functions in regulating devices and drugs. Having a more in-depth understanding of the FDA, and how it works to ensure the safety and effectiveness of medical devices used by otolaryngologists in the above care settings is important. It enables otolaryngologists to know how they may play an active role in protecting the safety of their own patients, and in contributing to the nation’s public health related to medical devices. As discussed in two-part article, one critical role otolaryngologists can play in assisting FDA in its mission to protect and promote the public health is that of an “active reporter”of problems they encounter with actual clinical use of medical devices.
The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for reviewing pre-market applications for medical devices to ensure that the devices meet the regulatory requirement of a reasonable assurance of safety and effectiveness. CDRH utilizes both pre-market programs to review device information prior to permitting manufacturers to legally market medical devices, and post-market programs to perform surveillance of device performance once it is in widespread clinical use. It also has research, compliance, and educational components that round out the Center’s efforts to protect and promote the public health with respect to medical devices. The focus of this two-part article is on the pre-market and post-market work conducted by CDRH, and how otolaryngologists can contribute to ensuring and optimizing medical device safety for their patients.
No device is risk free, regardless of the level of pre-market review prior to marketing the device in the broad clinical community. Rare, yet potentially serious safety problems, a significant rise in anticipated risks, design problems, quality issues, and manufacturing problems may occur once any device is in widespread use. These post-market issues may occur regardless of regulatory class and whether or not the device underwent pre-market clinical testing. This may be explained, at least in part, because conditions of use during the clinical trial phase for Class III devices (and for the Class II devices for which clinical data were also necessary) may differ from routine clinical use following FDA clearance or approval. For example, in a clinical study, the device is often used by highly trained and experienced physicians, in a limited number of study sites, and in a relatively small population that is well defined. However, once these devices are legally marketed in the U.S., the device is available for use by physicians with a wider range of training and experience. Hence, it may be used in a wider patient population, and the post-market clinical performance of the device may differ from that observed in clinical trial(s) with the device. Timely reporting by device users of problems associated with medical devices in clinical use in the post-market setting is therefore critical for both manufacturers and CDRH to protect the public health (i.e., monitor device performance to identify and promptly address actual and potential safety issues).
Once the devices are on the market, CDRH learns of problems from several sources. This is often through adverse event reports received from physicians, nurses, and consumers who experience problems. However, the reports from physicians and other users of various devices often lack sufficient detail or pertinent clinical information. This makes interpretation of the event and its significance more difficult.
Otolaryngologists can play a key role in protecting the health and safety of their own patients, as well as the patients they will never see, by collaborating with CDRH through reporting device problems. This should be to both the medical device manufacturers and the CDRH. For example, it is important to report device problems that resulted in harm to the user and/or the patient, or could have caused harm if intervention did not occur. Providing as much detail as possible regarding the procedure in which the device was used, any device identifiers, and the nature of the device problem from the clinician’s perspective is vitally important. Such information permits CDRH to better evaluate the issue and take appropriate action if necessary.
Otolaryngologists are highly encouraged to use the FDA’s MedWatch voluntary program to report any device problems they encounter that have or could affect their patients’safety. Reports may be submitted in several ways. To access the on-line and paper forms (FDA Form 3500), please visit https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm6.
You may choose to include your name or submit the information anonymously. However, it is helpful when contact information is provided. FDA analysts may need to contact you to discuss the report. Your identity is never released to the public, even if you include your name in the report.
Alternatively, you may access the recently launched mobile application, Medwatcher, to report using your phone or tablet. This is a new and convenient way to report problems with devices and other FDA regulated medical products. This method is easy and permits you to upload pictures of the device problem you are reporting. You may access this new application at http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/FormsandInstructions/ucm348271.htm7.
When CDRH receives a report, the post-market analyst may review the issue in a variety of ways, depending on the reported problem:
Researching previously reported events to identify patterns associated with the product;
Contacting the device manufacturer for its evaluation of the problem;
Talking with clinical users of the product to gain their perspective; and
Reviewing the literature concerning the product and specific reported issue
The analyst may consider many factors that could have caused or contributed to the event. These could include failures resulting from design, quality, manufacturing problems, human factor issues, and adverse device interactions (e.g., electromagnetic interference from one device to another).
Based on the findings, the analyst may determine that the issue should be monitored over time, or may decide that action is needed. Actions can be in conjunction with other offices within CDRH, and can include interactions with the manufacturer. They work with manufacturers in different ways: addressing labeling concerns, performing facility inspections, sending warning letters, issuing device recalls, creating requirements for post-market studies, sending “Safety Alerts”to healthcare professionals and consumers, authoring peer and non-peer reviewed articles, updating relevant websites, producing informative webcasts, conducting public workshops, and forming partnerships with device user organizations.8
Examples of some regulatory actions for otolaryngologic devices can be viewed on CDRH’s searchable database of all device recalls by entering the relevant information, such as device or manufacturer’s name. 9 An example of targeted communications to consumers and healthcare professionals, to inform them how to use devices safely, is the recent communication to consumers about the use of neti pots for rinsing nasal passages. 10 This communication resulted from several post-market reports of improper use of neti pots that may have caused or contributed to two deaths from a rare brain infection in 2011. The Louisiana State Health Department linked the infections to tap water contaminated with an amoeba called Naegleria fowleri that may have been introduced into the nose via neti pots.
In summary, otolaryngology is a complex, multifaceted surgical specialty that touches every part of the patient care experience including outpatient, emergency care, surgery, and nursing homes. Furthermore, our specialty has a history, present, and future of innovation that is necessary to provide cutting-edge care to patients. As such, we are especially vulnerable to issues with medical devices and products. This primer, written in conjunction between otolaryngologists and the FDA will hopefully draw attention to the significant role both groups have in medical device safety and surveillance. Physicians are encouraged to report events not only to the manufacturer, but also to CDRH. Many types of device problems occur intermittently. For this reason, large macro-level databases that are needed to rapidly identify trends in issues with a particular device. The onus lies with us to immediately and consistently report issues with devices we encounter. This allows the FDA to aggregate individual issues into meaningful, actionable data.
Medwatch Program https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm(Last accessed on 11-25-13).
Med watcher Mobile Application http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/FormsandInstructions/ucm348271.htm (Last accessed on 11-25-13).
Post-market Analyst Actions Flack, Marilyn; Gross, Thomas P.; and Samuels-Reid, Joy, et. al., “FDA Working to Ensure the Safety of Medical Devices used in the Pediatric Population,”pg. 1358, from, Pediatric Clinics of North America, December 2012, Editors Jacobs, Brian and Coppes, Max.
Recalls http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm295488.htm. (Last accessed on 11-25-13).
Consumer Updates http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm316375.htm (Last accessed on 11-25-13).
This is another in a series of articles being produced by the Medical Devices and Drugs Committee, written by committee members, consultants, and invited guests for the AAO-HNS membership. Do you have a question or topic we can address, which may fall under the committee’s charge? Do you have a comment about an article? Please let us know! Send an email to our coordinator, Harrison Peery at firstname.lastname@example.org and the chair, Anand Devaiah, MD, at email@example.com, with the subject line “MDDC question/article”so we can properly identify and answer your query. We strive to quickly answer our “fan mail.”Thanks in advance for your note, and helping to make sure we catch your email floating within the “Spamiverse.”Please note that we will ask your permission to publish your note, in anonymous or edited form, if it becomes the inspiration for a Bulletin article. Background
On July 11, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule focusing on payment policy updates to the 2015 Durable Medical Equipment, Orthotics, Prosthetics and Supplies (DMEPOS) fee schedule. Notably, as part of the rule, CMS is proposing to clarify the scope of the Medicare coverage exclusion for hearing aids and withdraw coverage of all types of air conduction and bone conduction auditory prosthetics (external, internal, or implanted). If finalized, the proposed rule would negate CMS’current coverage of osseointegrated implants.
CMS had expanded coverage to include osseointegrated implants as recently as 2005. In 2005, the auditory osseointegrated device was determined to be a new device category according to the new requirements for transitional pass-through payment during CMS’rulemaking. In the same regulatory revision, CMS additionally expanded coverage to both auditory osseointegrated devices and auditory brainstem devices, classifying them as prosthetic devices.
In the past, CMS has traditionally addressed the scope of the Medicare hearing aid coverage exclusion through program instructions and national coverage policies or determinations. However, this year, CMS decided to clarify the definition and its coverage determination of a hearing aid in its proposed rulemaking and comment period for DMEPOS payment rates.
CMS’ Rationale for its Proposed Coverage Exclusion
In the proposed rule, CMS states that bone conduction auditory prosthetics (along with other devices classified as “hearing aids”) do not meet the statutory definition of a prosthetic device found at section 1861(s)(8) of the Social Security Act which, in part, states a “prosthetic devices (other than dental) which replace all or part of an internal body organ.”CMS also states that osseointegrated implants are, “bone conduction hearing aids that mechanically stimulate the cochlea; therefore, we believe that the hearing aid exclusion applies to these devices and propose that Medicare should not cover these devices, consistent with our interpretation of section 1862(a)(7) of the Act.”CMS additionally mentions in the rule that a National Coverage Determination (NCD) was issued for cochlear implant devices with, “…the result that this determination and recent requests to expand coverage of hearing devices raises serious questions about the intent and scope of the Medicare coverage exclusion for hearing aids.”CMS also claims it initiated its examination of its definition of a hearing aid after receiving multiple benefit category determination requests in recent years for the consideration of non-implanted, bone conduction hearing aid devices for single-sided deafness, as prosthetic devices under the Medicare benefit.
Academy Advocacy Efforts
In response to the proposed rule, Academy leadership and health policy staff advocated on multiple levels and engaged Academy committees, sister specialty societies and other leaders among our membership (within Otology/Neurotology as well as health policy and government affairs staff) to craft comments that best represent our members and our patients. More specifically, Academy leadership and staff conferenced individually and collectively with members and chairs of the Hearing and Implantable Hearing Devices Committees to gather specific examples and feedback on how the proposed rule, if enacted, would negatively impact thousands of patients who have no other recourse to better hearing. Further, the Academy participated in three direct meetings with CMS, various audiology and public interest group conferences, and meetings with presidents of ANS and AOS. All of these efforts were directed at raising awareness of the dangers of this proposed rule and garnering support in defense of our position.
On September 2, 2014, the Academy, AOS, and ANS submitted a formal joint comment letter to CMS noting concerns about the proposal and providing a suggested alternative to the proposed rule that would allow for continued coverage of osseointegrated implants for Medicare patients.
Our efforts will extend beyond the comment period as opportunities to positively influence any adverse CMS decision become evident. We will continue to closely monitor the matter and will be sure to keep members apprised of pertinent information via the eNews, HP Update, website, and other outreach tools. Members are encouraged to regularly check the Get Involved Regulatory Advocacy page for important announcements and opportunities to positively effect change. The Regulatory Advocacy page is at http://www.entnet.org/content/regulatory-advocacy.
For the Academy leaders and members that took time out of your offices on short notice, or interrupted your vacations to personally participate in the aforementioned meetings and conferences, thank you. We greatly appreciate your dedication and willingness to get involved with these important policies.