Published: March 6, 2014

The Flexner Report: A Revolution in American Medical Education

Lanny G. Close, MD In the early 1900s, medical education in America was nothing like it is today. No government regulation existed and most medical schools were proprietary and without university affiliation. Only 10 percent of U.S. medical schools required two or more years of college education prior to admission. Medical students sat through long, boring, didactic lectures in large classrooms, and few schools offered any laboratory or clinical experience. In 1904, the American Medical Association (AMA), aware of the many deficiencies in American medical education, formed the Council of Medical Education (CME). Three years later, the CME inspected and ranked the 155 medical schools in America. Based on this study, the CME set minimum standards of admission and curriculum, but, fearing loss of support from their constituency (American-trained physicians), the CME decided not to publish its results. Rather, the AMA decided to “out-source” this project to the Carnegie Foundation for the Advancement of Teaching, an institution long respected for setting high academic standards. In 1908, Henry Pritchett, president of the Carnegie Foundation, appointed Abraham Flexner, a noted educator and non-physician, to conduct an “independent” investigation of American medical schools. It was understood that, without mentioning the CME’s findings, Flexner’s report would be published “far and wide” to build public support for a change in the system. From January 1909 through April 1910, Flexner, always accompanied by Nathan Colwell, MD, (a CME member) visited all 155 American medical schools. Overall, Flexner and Dr. Colwell agreed that most medical schools visited were “a disgrace,” “indescribably foul,” and “the plague spot of the nation.” Their book, Medical Education in the United States and Canada, aka the Flexner Report, was widely published in June 1910. It was not, however, endorsed by the AMA. The report called for minimum admission standards, two years of training in anatomy and physiology, and two years of clinical work in a teaching hospital. The public outcry following its publication caused a drop in the number of medical schools from 155 to 31 and the number of newly trained physicians was reduced from 4,400 a year to 2,000 a year. Many other changes resulted that markedly improved the quality of medical education in America; exemplified by today’s high standards.

Abraham FlexnerAbraham Flexner

Lanny G. Close, MD

In the early 1900s, medical education in America was nothing like it is today. No government regulation existed and most medical schools were proprietary and without university affiliation. Only 10 percent of U.S. medical schools required two or more years of college education prior to admission. Medical students sat through long, boring, didactic lectures in large classrooms, and few schools offered any laboratory or clinical experience.

In 1904, the American Medical Association (AMA), aware of the many deficiencies in American medical education, formed the Council of Medical Education (CME). Three years later, the CME inspected and ranked the 155 medical schools in America. Based on this study, the CME set minimum standards of admission and curriculum, but, fearing loss of support from their constituency (American-trained physicians), the CME decided not to publish its results. Rather, the AMA decided to “out-source” this project to the Carnegie Foundation for the Advancement of Teaching, an institution long respected for setting high academic standards.

In 1908, Henry Pritchett, president of the Carnegie Foundation, appointed Abraham Flexner, a noted educator and non-physician, to conduct an “independent” investigation of American medical schools. It was understood that, without mentioning the CME’s findings, Flexner’s report would be published “far and wide” to build public support for a change in the system.

From January 1909 through April 1910, Flexner, always accompanied by Nathan Colwell, MD, (a CME member) visited all 155 American medical schools. Overall, Flexner and Dr. Colwell agreed that most medical schools visited were “a disgrace,” “indescribably foul,” and “the plague spot of the nation.” Their book, Medical Education in the United States and Canada, aka the Flexner Report, was widely published in June 1910. It was not, however, endorsed by the AMA.

The report called for minimum admission standards, two years of training in anatomy and physiology, and two years of clinical work in a teaching hospital. The public outcry following its publication caused a drop in the number of medical schools from 155 to 31 and the number of newly trained physicians was reduced from 4,400 a year to 2,000 a year.

Many other changes resulted that markedly improved the quality of medical education in America; exemplified by today’s high standards.

More from March 2014 - Vol. 33 No. 03
Jackie L. Clark, PhD
Register Now! 5th International Conference on Global Hearing Health, July 25-26, St. Catherine’s College, Oxford, UK
James E. Saunders, MD, AAO-HNSF coordinator for International Affairs, cordially invites you to the next conference of the Coalition for Global Hearing Health (CGHH), July 25-26, at St. Catherine’s College in Oxford, England. Conference co-organizers, Dr. Saunders, of Dartmouth Hitchcock Medical Center, and Jackie L. Clark, PhD, of University of Texas at Dallas, have long-established roots in international arenas. Dr. Saunders is AAO-HNSF coordinator for International Affairs and past chair, Humanitarian Committee. Dr. Clark is chair, Humanitarian Efforts, International Society of Audiology. More than 100 representatives from multiple disciplines around the globe—including otolaryngologists, audiologists, teachers of the deaf, hearing aid providers, and international public health specialists—will confer for two days on providing global hearing healthcare in lower-resourced regions. The CGHH works to advance the Millennium Development Goals of the U.N. and the World Health Organization (WHO). For instance, the CGHH collaborates closely with WHO’s Prevention of Deafness Program, and the International Federation of Oto-Rhino-Laryngological Societies (IFOS) “Hearing for All” initiative. In particular, the CGHH focuses on areas where it can have the most influence: advocacy for better hearing healthcare, technical challenges and opportunities, increasing the workforce through quality training, empowering families and affected individuals, and establishing best practices and standards of care. To submit an abstract, register early for the conference, and reserve your room (from the limited block of rooms held for our attendees), visit http://coalitionforglobalhearinghealth.org. For highlights of the 2013 meeting, visit http://www.coalitionforglobalhearinghealth.org/RecentConference/ConferenceHighlights/tabid/171/Default.aspx.
Juan Manuel Garcia Goméz, MD Chair, AAO-HNSF Panamerican Committee President of the XXXIV Pan-American Congress of Otolaryngology
Pan-American Association Invites Academy Members to Cartagena, Colombia in October
In 1946, thanks to the vision and leadership of Chevalier Jackson, MD, with U.S. and Latin American colleagues, the Pan-American Association of Oto-Rhinolaryngology-Head and Neck Surgery was founded in Chicago, IL, during the 51st meeting of the American Academy of Otolaryngology—Head and Neck Surgery. Responding to the need for a strong scientific and social exchange among specialists on our continent, the Association has created the great and enduring Pan-American community that has organized the Pan-American Congress of Otolaryngology continuously every two years for more than six decades. All members of accredited societies of otorhinolaryngology in the Americas—including Academy members—are active members of the Pan-American Association. As president of the XXXIV Pan-American Congress, it is an honor and privilege to extend a special invitation to all Academy members to join us October 26-29 in the beautiful city of Cartagena, declared a World Heritage Site by UNESCO in 1984. Roy R. Casiano, MD, of the University of Miami, immediate past president of the Panamerican Association and past chair of the Academy’s Panamerican Committee stated: “Attendees will be exposed to the latest scientific and technological advances within the various disciplines of otolaryngology, while enjoying the warm camaraderie that our social events bring.” President of the Pan-American Association Luis A. Macias, MD, of Mexico City, expressed: “One of the statutory principles of our Association is the exchange of knowledge and advances in our specialty for the benefit of our patients; this task has been fully complied in our meetings, thanks to the active participation of its members.” Undoubtedly, Cartagena is a Colombian touristic and historic jewel of the Caribbean—it has hosted the most important world events of politics, science, and international trade. Cartagena has a world-class hotel infrastructure and the Las Américas Global Resort and InternationalConvention Center meet all the criteria for a successful Congress. A highlight of the Congress program will be a joint meeting of the Academy and the Panamerican Association, supported by James E. Saunders, MD, international coordinator, and J. Pablo Stolovitzky, MD, regional advisor for Latin America, with speakers from both societies. In addition, the Congress will provide a booth for the Academy to display its educational offerings in the exhibit hall. I specially recommend our Pan-American Association website (http://www.panamorl.com.ar/) excellently managed by Hector E. Ruiz, MD, of Rosario, Argentina, founder and past chair of the AAO-HNSF Panamerican Committee. On behalf of the Colombian Society of Otolaryngology, our president, Antonio Jose Reyes Solarte, MD, our scientific coordinator, Roxana Cobo Sefair, MD, the organizing committee, and all Colombian otolaryngologists, we hereby extend a friendly invitation to all Academy members. For details, visit www.panamorl2014.com. Key Dates to Remember Early bird registration is open until March 31. Scientific Program abstracts submissions deadline is June 30.
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Ethiopia Surgical Trip: Serving Local Physicians
Audrey P. Calzada, MD Clinical Fellow, Otology/Neurotology House Ear Clinic I had the privilege of traveling as part of the team led by Glenn Isaacson, MD, with Healing the Children to Ethiopia at the end of October. We spent two days in Addis Ababa giving lectures to the otolaryngology residents at Addis AbabaUniversity and seeing mostly children in a clinic at the mission hospital, CURE, and at the MakanissaSchool for the Deaf. We spent the remainder of the week in Mekelle, the third largest city in Ethiopia. We operated on and saw patients with Adamu Yilikal, MD, who is the only otolaryngologist in the northern half of the country, serving more than eight million people. The goal of our trip was to equip local surgeons to better serve their communities by providing equipment, clinical instruction, and operative teaching. Our team consisted of four otolaryngologists, one anesthesiologist, three audiologists, and the president of Healing the Children. We had the opportunity to provide and observe medical care in several different healthcare settings within Ethiopia: a non-profit mission hospital, a government hospital, and a mission school for the deaf. Visiting and working in each center allowed for comparing and contrasting the benefits and downfalls of each place in partnering to provide healthcare to the people of Ethiopia. We began our week at the mission hospital, CURE, which is a non-profit, privately funded surgical hospital for children in Addis Ababa with high standards of excellence. Because Dr. Isaacson and anesthesiologist Elizabeth Drum, MD, have led multiple teams there during the past five years, the clinic we ran consisted of both new and returning patients, who had previous operations by our team. The equipment, all donated and brought by surgical teams, was organized and sufficient. The flow of the operating room, directed by an anesthesiologist from the United States, was efficient and smooth. While this surgical hospital provides excellent, free care to children, the leadership is largely foreign-based and western-trained, which limits its ability to build local healthcare expertise. In contrast to CURE, the government hospital in Mekelle, where we performed otologic and head and neck cases with Dr. Yilikal, was poorly equipped and inefficiently run despite hard-working, intelligent staff. One main hindrance to safe operative care in Ethiopia is the absence of anesthesiologists with medical degrees. In addition to training Dr. Yilikal and his residents to perform essential otolaryngologic procedures, we provided surgical instruments and equipment. Despite working there for two years and being the only otolaryngologist in the region, he had instruments to perform only tonsillectomies prior to our visit. In addition to the lack of well-trained ancillary staff and equipment, there was also the issue of consistent electricity in this large government hospital. It was extremely humbling to realize the large amount of infrastructure required to perform safe operations. The Ethiopian leaders of the government hospital in Mekelle were overwhelmingly hospitable. Through discussions with them over meals in the evening, I was inspired by their simultaneous understanding of the plight of medical care in Ethiopia and their courage to continue seeking out opportunities to improve the standard of care. I began to better understand the issues developing countries face when their educated class chooses to live and work in other countries with more opportunities. Even if disregarding financial provision for their families and future educational opportunities for their children, there is a seemingly insurmountable ceiling of advancement within surgical subspecialties. Not only are opportunities to develop adequate surgical skills in quality training programs lacking, there is no support or equipment to build a meaningful practice. What impact can a practicing otolaryngologist in a community of eight million people make without a microscope, surgical instruments, and trustworthy anesthesia? These are issues that have been courageously and tirelessly addressed by Dr. Isaacson (Dr. Glenn, as he is known in Ethiopia) during the past six years. To detail the equipment and support provided to the Ethiopian otolaryngology community is one thing, but I was equally struck by his tenacity in dealing with the minute-to-minute issues we all faced with improvisation and patience. As my emotions regarding medical humanitarian work positively impacting a developing community wavered between hopelessness and optimism, I observed that our trip leaders were quietly and diligently changing the practice of otolaryngology in Ethiopia. As I complete my fellowship training, I desire to be useful in service to others, and I hope to partner with surgeons in other parts of the world to better serve their communities. I am thankful to the AAO-HNSF Humanitarian Committee for providing grant support for this trip. I return inspired and humbled by the attitudes and hard work of my colleagues both in this country and in Ethiopia.
Prof. A. Sameh Farid, MD, dean of the Cairo University Medical School, presided over the conference, which included presentations by members of both organizations. Cairo University at night.
AAO-HNS, Egyptian ORL Society Celebrate First Joint Satellite Meeting
Ahmed M. S. Soliman, MD Five years since its conception and after nearly a year of planning, the first Combined Satellite Meeting of the American Academy of Otolaryngology—Head and Neck Surgery and the Egyptian Society of Otorhinolaryngology took place September 28, 2013, in Vancouver, BC,  Canada. This historic event was co-chaired by Ahmed M. S. Soliman, MD, of Temple University and Prof. M. Adel Khalifa, MD, of Tanta University, Egypt. Eugene N. Myers, MD, FRCS Ed (Hon), professor and chair emeritus, University of Pittsburgh, and Prof. A. Sameh Farid, MD, dean of the CairoUniversityMedicalSchool, presided over the conference, which included presentations by members of both organizations. Prof. Khalifa presented Dr. Myers with the Honorary Shield of the Egyptian ORL Society for his many contributions to advancing cooperation between the two groups. James L. Netterville, MD, president of the AAO-HNS, and President-Elect Richard W. Waguespack, MD, gave welcome remarks. Scientific presentations included “Endoscopic Management of Reinke’s Edema” by Peak Woo, MD, “Treatment of laryngeal malignancies with plasmonic photothermal therapy” by Prof. Hazem Saleh, MD, and “Correlation between neural response telemetry and CT scanning of electrode position in pediatric cochlear implant patients” by Ahmed H. Allam, MD. Other presenters included G. Richard Holt, MD, D-BE, MSE, MPH; Ivan H. El-Sayed, MD; Ellen S. Deutsch, MD; Nicholas Y. BuSaba, MD; Gregory W. Randolph, MD; Basim M. Wahba, MD, DOHNS, MRCS; and Prof. Ahmad S. El-Guindy, MD. The meeting concluded with a dinner reception at Milestones Vancouver. Drs. Allam and Wahba, 2014 AAO-HNSF International Visiting Scholars, were honored at the International Assembly and International Reception. Two previous combined meetings of the two societies, in 2012 and 2013, planned for Cairo, had been cancelled because of political unrest. In his closing remarks, Dr. Randolph, chair, International Steering Committee, congratulated the organizers for their persistence and perseverance that finally brought the meeting to fruition despite many odds.
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The Increasing Role of Technology in Continuing Medical Education
The future of continuing medical education (CME) will be based on the latest technology available. Increasingly, physicians are seeking online resources to get CME credit. This trend is likely to continue as the time constraints of a busy practice will require you to seek easily accessible professional development opportunities. Physicians are becoming increasingly technology savvy. Recent studies have shown a general shift to physicians preferring online CME activities. The trend is also more mobile with the majority of physicians owning smartphones and tablets. Many use these tools to search for and download clinical information. Many see the trend toward increased virtual CME and are embracing it as a viable alternative to live activities. Otolaryngologist-head and neck surgeons are no exception to the tech savvy trend. According to the recent Member Education Needs Survey, the majority of members consider themselves innovators or early adopters of technology, including online learning, e-books, and mobile applications. There was a clear preference among members for more Web-based education formats. Members indicated they are using smartphones, tablets, and e-readers for continuing education information. According to the survey, 55 percent use a tablet, 54 percent use a smartphone, and 13 percent use an e-reader as a source for both continuing education and professional information. Preferred learning formats included online self-paced courses, smartphone and tablet apps, and webinars. When asked what changes are expected that will affect their education needs, many member responses centered on new e-learning technology. These include an increase in: The move to online learning Virtual meetings and lectures Materials available on smartphones and tablets Online material supplanting print methods Interactive, online content and assessment Easily available e-seminars Faster and more up-to-date information available on the Web Internet-based teaching Online asynchronous learning Simulation The Foundation is continually exploring ways to improve education opportunities for members. New technologies within professional education provide many options to enhance one’s learning experience. Survey respondents offered useful suggestions about integrating more technology into the Foundation’s education program. Because of these preferences and expectations, the focus will be toward more e-learning in the design of future education and knowledge resources. There are several projects in the works at the AAO-HNS/F that, through technology, will provide more meaningful and rewarding education, knowledge products, and services for you in 2014. Your feedback indicates that in addition to traditional educational methods, a growing number of members desire a larger e-learning environment and expanded electronic platform. Armed with a better appreciation of our members’ preferred learning styles in education and training, combined with today’s expanding technology, we will be better equipped to offer many new and varied formats to enhance learning experiences.
Physician Compare: What Is It and How Does It Affect Me?
Background Under the Affordable Care Act (ACA), the Centers for Medicaid & Medicare Services (CMS) is required to develop a Physician Compare website with information on physicians enrolled in the Medicare program, and information on other Eligible Professionals (EPs) who participate in PQRS. Essentially, CMS is charged with making information on physician performance, including information on quality measures and patient experience, available through the Physician Compare website. To meet that end, CMS must send a report to Congress on Physician Compare development, including information on efforts and plans to collect and publish data on physician quality and efficiency, and on patient experience of care in support of value-based purchasing and consumer choice by January 1, 2015. The ACA allows for CMS to expand information made available on Physician Compare any time before that date. The first phase of the website launched in 2010, but in 2013, CMS released a redesigned Physician Compare website. The primary source of administrative information on Physician Compare is from the Provider Enrollment, Chain, and Ownership System (PECOS), with the use of Medicare claims information to verify the information in PECOS. It is important to note that members must ensure their information is up-to-date and accurate in the national PECOS database. In addition, any information not found in PECOS, such as hospital affiliation and foreign language, must be updated by emailing the Physician Compare team at physiciancompare@westat.com. Information that is currently reflected on the site includes: address; education; American Board of Medical Specialties (ABMS) board certification information; primary and secondary specialties; group affiliations; hospital affiliations that link to the hospital’s profile on Hospital Compare as available; Medicare Assignment status; and Provider language skills. In addition to the aforementioned, the Physician Compare website also includes: Individual Quality Information On each individual profile page there is a section listing the quality programs under which the specific individual satisfactorily reports and if he or she is a successful electronic prescriber. A notation and check mark for individuals that successfully participate in the Electronic Health Records (EHR) Incentive Program is also included. Group Quality Information In addition to that included for individuals, CMS also built-in a quality programs section for each group practice profile page to indicate which group practices are satisfactorily reporting using the GPRO web-interface for PQRS reporting, or are successful electronic prescribers under the eRx Incentive Program. New Additions to Physician Compare Within the newly released CY 2014 Medicare Physician Fee Schedule Final Rule, several new additions to the Physician Compare website were finalized. These changes include the following: Physician Compare will publicly report ALL quality measures collected through the Group Practice Reporting Option (GPRO) web interface for groups of all sizes.  Note: A 30-day review period for quality measures on Physician Compare will be given, but not for non-measure data such as telephone number, specialty, etc. Physician Compare will publicly report performance on GPRO registry and EHR measures. Note: CMS highlighted that it will conduct analyses to ensure that measures collected via different mechanisms are consistently understood and only measures proven to be comparable and most suitable for public reporting will be included on Physician Compare. Physician Compare will publicly report Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) measures for groups of 100 or more EPs who participate in PQRS GPRO, regardless of submission method. Physician Compare will publicly report CG-CAHPS for Medicare Shared Savings Plan (MSSP) Accountable Care Organizations (ACOs) reporting through the GPRO web interface. Physician Compare will publicly report CG-CAHPS measures collected via a certified CAHPS vendor for groups of 25 to 99 EPs. Physician Compare will publicly report performance on 20 measures listed in the proposed rule that are reported by individual eligible professionals reporting through an EHR, registry, or claims during 2014 under the PQRS. Note: The only measures that appear applicable to ENTs for the above categories are Medication Reconciliation and Preventive Care and Screening: Tobacco Use: Screening and Cessation. CMS plans to publicly report 2014 data in CY 2015. For more information on Physician Compare, visit www.medicare.gov/physiciancompare or email the health policy team at healthpolicy@entnet.org.
Quality in the Era of Value-Based Purchasing
Quality in the Era of Value-Based Purchasing
Rahul K. Shah, MD George Washington University School of Medicine, Children’s National Medical Center, Washington, DC The concept of value in healthcare is not novel—almost everyone is familiar with the well-known equation: value = quality of care/cost of such care. To increase the value of healthcare delivery, we can simplistically increase the quality of the care that is delivered or the perception of that delivered care; one can also reduce the cost of that care. Currently, the in-vogue statement is “value-based purchasing.” This month’s column will attempt to convey my strong sentiment about how value-based purchasing is actually a complex transaction that will fundamentally change the way we approach the care we deliver to patients. Further, Academy members are uniquely positioned, as a result of the diverse patients we care for, to lead and help explain this concept within our offices and organizations. The concept of value-based purchasing is predicated on the premise that with all else being equal, the cheaper option should be chosen. Using the value equation above, we can see that if we hold the quality of care as a constant, then the way to drive up the value of care is to choose the less costly alternative. Value-based purchasing is juxtaposed to volume and intensity of service programs. Healthcare has been predominantly based on the volume/intensity of service model. For example, more cases generate more volume, which means the “rainmaker” would be more highly compensated; another way to think about volume-based reimbursement is that the patient that has a longer length of stay would yield more revenue to the hospital than a similar diagnosis patient that has half as long of a stay. Indeed, many hospitals are caught with feet in both of these worlds: the volume model and the value-based purchasing model. I have been struggling to make the business case for quality from a surgical perspective within a paradigm of value-based purchasing. However, the following analogy should shed some light on this complex issue. Let us start with a common surgery that has more or less a relatively tight range of fixed costs to perform the case—an adenotonsillectomy. There are myriad techniques to perform this procedure, and they all have fixed costs that probably range from .5x all the way to about 4x (“x” denotes the average fixed costs to perform an adenotonsillectomy). We rarely think past this point, and I am sure that most Academy members are not too terribly concerned about the fixed costs of our cases. However, in a value-based purchasing mindset, we would need to take into account the entire spectrum of care to make a business case. For example, if there is a method to perform an adenotonsillectomy that costs 4x (four times the average cost), then in a volume/intensity of care model, we may not look favorably at this method, and management/administration may not want this technique with such high fixed costs and low profit margins. In an era of value-based purchasing, if the overall quality of the patient care improves and their outcomes improve, then there would be a rationale to consider using this device despite the increased fixed costs. For example, if the patient can be discharged sooner (even from PACU), the result is less use of hospital resources (expenses) and thus using the value equation from the opening of this column, the overall costs have decreased slightly but the quality for the patient has improved. This would result in higher reimbursement than otherwise in a value-based reimbursement model. By using a concrete example from our realm of care, I hope this column helps explain how complex value-based purchasing/reimbursement is and how as healthcare providers we must be cognizant of the entire spectrum of the patient’s care delivery. This is even more complex for our Academy members as otolaryngology-head and neck surgery spans a uniquely broad (out-patient, in-patient, emergency, elective, etc.) range of care. We encourage members to write us with any topic of interest and we will try to research and discuss the issue. Members’ names are published only after they have been contacted directly by Academy staff and have given consent to use their names. Please email the Academy at qualityimprovement@entnet.org to engage us in a patient safety and quality discussion that is pertinent to your practice.
You Asked, We Delivered: Academy Achieves Modification to NCCI Edit for CPT 31000
Last August, the Academy received inquiries from members who pointed out that the existing Correct Coding Initiative  (CCI) edits for (non-endoscopic) CPT 31000 Lavage by cannulation; maxillary sinus (antrum puncture or natural ostium, permitted providers to circumvent the CCI edit of “1,” which bundles this service when performed in conjunction with codes 31256 Nasal/sinus endoscopy, surgical, with maxillary antrostomy and 31267 Nasal/sinus endoscopy, surgical, with maxillary antrostomy; with removal of tissue from maxillary sinus, by appending a -59 modifier. In response, we drafted a letter to the National Correct Coding Initiative  (NCCI) staff and Centers for Medicare & Medicaid Services (CMS), noting that there are real, but uncommon, instances for which the modifier is appropriate, so the edit for these code combinations should not be “0.” We also noted that no CCI edit currently exists for the code combination of 31000 and 31295 Nasal/sinus endoscopy, surgical; with dilation of maxillary sinus ostium (e.g., balloon dilation), transnasal or via canine fossa. NCCI staff responded that they, and accordingly, CMS agreed with the Academy that CPT 31000 may be reported separately with 31256 or 31267 if the lavage is performed on the contralateral sinus and may be reported with modifier 59 in such circumstances. CMS also agreed that it would be appropriate to add an edit bundling CPT 31000 into 31295, and that similar edits bundling 31000 and 31002 Lavage by cannulation; sphenoid sinus into other procedures of the maxillary and sphenoid sinuses respectively, based on the same rationale (i.e., lavage is integral to the more extensive sinus procedure). However, if lavage of a sinus and a more extensive procedure are performed on the contralateral sinus, they may be reported together with the appropriate modifiers. These new edits will take effect April 1. For more information regarding this CCI edit change and proper coding for these services, visit our Coding Corner on the Academy website, which includes a CPT for ENT that outlines these issues further: http://bit.ly/CPT4ENT. The Academy is pleased that CMS, and the NCCI, have agreed to implement this change. To access the full response from NCCI, visit http://bit.ly/NCCIMUE. We encourage members to keep health policy staff abreast of any similar coding issues they encounter in the future. We urge you to email us at healthpolicy@entnet.org with any questions related to this issue or other coding and reimbursement matters.
CMS Issues CY 2014
CMS Issues CY 2014 Outpatient Prospective Payment System and Ambulatory Surgical Center Payment Final Rule: What Academy Members Need to Know
OPPS 2014 Final Payment Rates For Calendar Year (CY) 2014, CMS finalizes a hospital outpatient department conversion factor of $71.219. This is based on a hospital inpatient market basket rate increase of 2.5 percent, minus the proposed multifactor productivity (MFP) adjustment of -.5 percent, and the -.3 percent adjustment, which are both required under the Affordable Care Act (ACA). CMS has also proposed to continue implementing the statutory 2 percent reduction in payments for hospitals that fail to meet the hospital outpatient quality reporting (OQR) requirements. Updates Affecting OPPS Payments In CY 2014, CMS has continued the changes made in 2013 to base the relative weights on geometric mean costs rather than previously utilized median costs. It will continue to use these weights to set a cost to charge ratio within an APC to determine payment for services within an APC. In CY 2014, CMS finalizes several significant changes to their methodology to calculate APC payments, including: Greatly expanding the types of services that are packaged and not paid separately; Replacing the current five levels of visit codes for clinic visits with a single new alphanumeric Level II HCPCS code representing one level of payment for all clinic visits; the final rule maintains current codes for Type A emergency department (ED) and Type B ED visits; Using distinct cost-to-charge ratios (CCRs) for cardiac catheterization, CT scan, and MRI to calculate the relative payment weights; and Effective January 1, 2015, establishing comprehensive APCs for 29 device-dependent services and make a single payment for the comprehensive service based on all OPPS-payable charges on the claim. To see a complete list of APCs and the influence on their payment rates, see Addendum B: http://www.entnet.org/Practice/loader.cfm?csModule=security/getfile&pageid=180429 Changes to APC Assignments Affecting Head and Neck Surgery Within the final rule, CMS makes several changes to APC assignments for otolaryngology services, including assigning new CPT code 64617 Chemodenervation of Larynx to APC 0206 with a 2014 APC payment rate of $353.99. Further, CMS modifies the APC assignment of CPT 31571 Direct Laryngoscopy from APC 0075 to 0074, representing a change in reimbursement from $2,026.82 in 2013 to $1,880.43 in 2014. Similarly, CMS modified APC assignments for Balloon Sinus Codes CPT 31295 and 31296 to assign them to APC 0075 in CY 2014 and for 31297 and 31541 from APC 0075 to 0074 for 2014. This results in a change in payment for 31295 and 31296 from $2,026.82 in 2013 to $3,051.76 in 2014 and from $2,026.82 in 2013 for CPT 31297 and 31541 to $1,880.43 in CY 2014. OPPS Payment for Hospital Outpatient Visits For CY 2014, CMS establishes a single visit code for hospital clinics, replacing the five visit levels used in the OPPS since 2007. The mid-level clinic visit, APC 606, has been the most frequently used outpatient hospital visit code. Under the final rule, the new single level clinic visit, APC 0634, would have a base payment rate of $92.53 in 2014, a reduction of about 4.6 percent compared to the current payment rate of $96.96 for the mid-level clinic visit (APC 606). They believe a policy that recognizes a single visit level for clinic visits under the OPPS is appropriate for several reasons, including: The policy is in line with their goal of using larger payment bundles to maximize hospitals’ incentives to provide care in the most efficient manner. The policy will remove any incentives hospitals may have to provide medically unnecessary services or expend additional, unnecessary resources to achieve a higher level of visit payment under the OPPS. The policy will reduce hospitals’ administrative burden by eliminating the need for them to develop and apply their own internal guidelines to differentiate among five levels of resource use for every clinic visit they provide, and by eliminating the need to distinguish between new and established patients. Lastly, they believe that removing the differentiation among five levels of intensity for each visit will eliminate any incentive for hospitals to “upcode” patients whose visits do not fall clearly into one category or another. Supervision of Outpatient Therapeutic Services in CAHs and Small Rural Hospitals CMS ends its non-enforcement policy requiring direct supervision of outpatient therapeutic services in CAHs and small rural hospitals; thus, for years beginning with 2014, CAHs and small rural hospitals have to comply with the CMS supervision policy which requires direct supervision of therapeutic services, except for those that CMS identifies as appropriate for general supervision. CMS believes that it is appropriate to let this grace period expire to ensure the quality and safety of hospital and CAH outpatient therapeutic services provided by Medicare. Supervision for Observation Services In addition, CMS clarified that for observation services, if the supervising physician or appropriate non-physician practitioner determines and documents in the medical record that the beneficiary is stable and may be transitioned to general supervision, general supervision may be furnished for the duration of the service. Medicare does not require an additional initiation period(s) of direct supervision during the service. CMS believes that this clarification will assist hospitals in furnishing the required supervision of observation services without undue burden on their staff. Hospital Outpatient Quality Reporting (OQR) Program As established in previous rules, hospitals will continue to face a 2 percent reduction to their OPD fee schedule update for failure to report on quality measures in the OQR Program in CY 2014. Program measures can be accessed at www.QualityNet.org. In its final rule, CMS reiterates its intention that the hospital OQR program will transition to the use of certified EHR technology for submission of data on those measures that require information from the clinical record. CMS estimates this transition will occur sometime after 2015, and notes much work remains to reach this point, including developing electronic specifications, pilot testing, reliability and validity testing, etc. ASC 2014 Final Payment Rates:  For CY 2014, the ASC conversion factor will increase 1.2 percent—this reflects the updated consumer price index (CPI-U) (a consumer price index for all urban consumers) of 1.7 percent, minus the projected multifactor productivity adjustment of -0.5 percent required by the ACA, and results in a proposed increase in the conversion factor from $42.917 in 2013 to $43.471 in 2014. New ASC Covered Surgical Procedures for 2014 CMS approves four new procedures for coverage in the ASC setting in CY 2014. Notably, two of these procedures are commonly performed by ENTs: CPT 60240 thyroidectomy, total or complete and 60500 Parathyroidectomy or exploration of parathyroid(s). Both codes were assigned an ASC payment indicator of G2, meaning: Non office-based surgical procedure added to ASC list in CY 2008 or later; payment based on OPPS relative payment weight. CMS also flags new CPT code 64617 Chemodenervation of larynx as temporarily office-based for CY 2014 and assigns it a payment indicator of P3, meaning the payment rate is capped at the MPFS practice expense rate. Surgical Procedures Designated as Office-Based Annually, CMS proposes to update payments for office-based procedures and device-intensive procedures using its previously established methodology. Office-based procedures are defined as surgical procedures, which are used more than 50 percent in the physicians’ offices. For CY 2014, CMS permanently identified three additional procedures as office-based and has reviewed information for the eight procedures finalized for temporary office-based status last year. None of the services discussed relate to our specialty. The Academy, however, continues to track policy change in this area as several ENT services were added to this list in 2013 rulemaking. ASC Quality Reporting Program: In 2012, CMS finalized the implementation of an ASC quality-reporting program (ASCQR), which will begin with 2014 payment determination. Quality measures have been adopted for the calendar years 2014-2016. Payment penalties for ASCs who do not adequately report will remain at 2 percent. Penalties will be applied in CY 2016 payments based on 2014 reporting.  Quality measures can be found at www.Qualitynet.org. For more information on the final rule access the Academy’s full summaries of OPPS and ASC finalized requirements at http://www.entnet.org/Practice/Summaries-of-Regulations-and-Comment-Letters.cfm#CMSRegs or email questions to Academy health policy staff at HealthPolicy@entnet.org.
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FDA’s ENT Panel Reviews Safety and Effectiveness of Hybrid Cochlear Device
On November 8, 2013, the Food and Drug Administration (FDA) Ear Nose and Throat Devices Panel (ENT panel) met in Silver Spring, MD, to discuss the safety and effectiveness of a new hybrid cochlear implant device, the Nucleus® Hybrid™ L24 Implant System (Hybrid L24). The goal was to make a decision about pre-market approval status. The Hybrid L24 is designed for the treatment of adults who are 18 or older, have residual low-frequency hearing sensitivity and bilateral severe-to-profound high-frequency sensorineural hearing loss, and obtain limited benefit from hearing aids, among other indications. The meeting included presentations from the sponsor, Cochlear™ Americas, and the FDA, followed by deliberations from the ENT panel and a panel vote on FDA questions about safety and effectiveness of the device. Several Academy leaders have prominent roles at the FDA, and many voting members of the FDA panel are also Academy members. Notably, Gayle E. Woodson, MD, AAO-HNS president-elect, serves as the chair of the FDA ENT panel, along with several Academy members. Anjum Khan, MD, MPH, also an Academy member and a medical officer with the FDA, presented on the safety and effectiveness of the Hybrid L24. In addition, Academy members J. Thomas Roland, MD, and Bruce J. Gantz, MD, both attended and presented at the meeting as principal investigators of the device. Dr. Roland served as the lead investigator for a clinical study performed on the Hybrid L24 for four and a half years, and previously served on advisory boards for manufacturers of cochlear implants, and currently serves as co-director of the NYU Cochlear Implant Center. Dr. Gantz served as a principal investigator in Iowa and serves as the chair of the department of otolaryngology-head and neck surgery at Iowa’s Carver College of Medicine. Several other Academy members who were not present for the meeting also served as investigators at various sites, including Jacques A. Herzog, MD; R. Stanley Baker, MD; Colin W. Driscoll, MD; Charles M. Luetje, MD; Andrew J. Fishman, MD; Bradley Welling, MD, PhD; David Kelsall, MD; and Ravi N. Samy, MD. The following Academy members sat in on ENT panel discussions as voting members or temporary voting members, including Steven W. Cheung, MD, MBA; Roberto A. Cueva, MD; Barry E. Hirsch, MD; Michael E. Hoffer, MD, CAPT MC, USN; Akira Ishiyama, MD; Herman A. Jenkins, MD; Margaret A. Kenna, MD, MPH; Arnaldo L. Rivera, MD, CDR, MC; Jeffrey T. Vrabec, MD; Bevan A. Yueh, MD, MPH; and Ronald von Jako, MD, PhD. After listening to several patient experiences and clinical research presentations, the FDA panel members deliberated, and unanimously recommended that the Hybrid L24 device is safe, effective, and provides benefits that outweigh the risks for patients meeting the criteria specified in the proposed indications. The FDA is not bound by the recommendations of its advisory committees, but will consider the recommendations and guidance during the final review of the device. For further details on research presented at the meeting and other relevant materials, please visit the FDA website and view the committee meeting materials at http://tinyurl.com/lyk3qhk.
The next meeting of the AMA House of Delegates will take place June 7-11 in Chicago, IL.
Key AMA Policy Changes Affecting Our Specialty: Interim Meeting Recap
Liana Puscas, MD Chair, AAO-HNS Delegation to the AMA House of Delegates The American Medical Association (AMA) conducted its 2013 Interim Meeting November 15-19, at National Harbor, MD. Delegates included Liana Puscas, MD (delegation chair); Michael S. Goldrich, MD; Shannon P. Pryor, MD; and Robert Puchalski, MD. At the meeting, Dr. Pryor served as the chair of Reference Committee F (Finance and Governance) and Dr. Puchalski was re-elected Secretary of AMPAC. David Nielsen, MD, AAO-HNS EVP/CEO, served as alternate delegate, with staff support from the AAO-HNS Government Affairs and Health Policy teams. Below is a summary of key issues discussed at the meeting affecting otolaryngology-head and neck surgery. Defining Team-Based Care Reflective of myriad practice patterns in the U.S., the AMA House of Delegates (HOD) was unable to agree on the best language regarding the definition of the terms “physician-led, collaborative, and supervision,” so the Board of Trustees will continue to research and refine the language with the expectation that consensus will be reached at AMA’s annual meeting in June 2014. FDA Oversight of Tobacco/Nicotine Products The AMA HOD adopted policy urging the U.S. Food and Drug Administration (FDA) to immediately implement the deeming authority written into the FDA tobacco law to extend FDA regulation of tobacco products to pipes, cigars, hookahs, e-cigarettes, and all other non-pharmaceutical tobacco/nicotine products not currently covered by the FDA tobacco law. SGR Strategies The AMA conducted a candid discussion regarding strategies to repeal the Sustainable Growth Rate (SGR) payment formula. With the current climate being the best it has been to finally achieve success on this issue that is so important to physicians, all of organized medicine is working hard to make this goal a reality. ICD-10 Implementation There were continued appeals to either further delay or completely rescind implementation of ICD-10. Whereas most hospital systems and larger practices have already moved toward use of ICD-10 prior to its October 1, 2014, mandatory implementation, many others without a robust IT infrastructure have not. Physicians are concerned about the cost and the timing since it overlaps with many other significant changes occurring in healthcare. While the AMA was able to achieve a one-year delay in the implementation from 2013 to 2014, it is unlikely that CMS will approve a further delay. Represent the Specialty, Join AMA The next meeting of the AMA House of Delegates will take place June 7-11 in Chicago, IL. Of note, the AAO-HNS should try to increase its AMA membership. AMA delegations are in proportion to an organization’s number of AMA members, and in order to keep our four delegates and help maintain otolaryngology’s representation in the HOD, it is necessary that we grow our AMA membership. Many have disagreed with some of the AMA’s positions, but it is still the best voice for medicine as a whole, and increased participation is the only way to influence actions taken by the AMA. Our delegation is small, but all four members currently are or recently have been actively involved in leadership within the organization serving on councils, reference committees, and the AMA’s political action committee. Although we may be few in number, we are strong in voice, and that helps keep otolaryngology’s perspectives and issues on the radar. Questions about this report and other AMA HOD activities, please email govtaffairs@entnet.org.
On the Frontlines: State Legislative Tracking
The 2014 state legislative sessions are in high gear, and a number of the specialty’s priorities are being debated by state lawmakers. AAO-HNS members are a key resource for tracking state legislation and communicating to policymakers its influence on the specialty, physician practices, and patients. Join the growing team of AAO-HNS state trackers by emailing govtaffairs@entnet.org to receive daily or weekly legislative tracking updates. If you identify legislation needing Academy action (e.g., letter, action alert, testimony), simply fill out the new online State Action Form at www.entnet.org/Advocacy.
Candidate-Member: John Bizon, MD
Academy Members Take a Political Spotlight
The 2014 mid-term election year is upon us, and it is already shaping up to be an exciting year! To date, two AAO-HNS members have announced their candidacy for office in their respective states. In Michigan, John Bizon, MD, has announced his candidacy for the state’s House of Representatives in the 62nd district. Dr. Bizon is running as a Republican and currently has no opponent. The incumbent state representative for the 62nd district, Rep. Kate Segal, a Democrat, is unable to seek re-election due to term limit restrictions. Prospective candidates have until April 22 to file paperwork for Michigan’s 2014 elections. Dr. Bizon is a resident of Battle Creek and is the immediate past president of the Michigan State Medical Society. The Michigan primary is scheduled for August 5, with this year’s general elections taking place on November 4. On the federal level, Robert E. Johnson, MD, is a Republican candidate in the open seat race to replace U.S. Representative Jack Kingston in Georgia’s first Congressional district. Dr. Johnson, who prefers the moniker “Dr. Bob,” is a former Army Ranger and previously owned a private ENT practice in Georgia. With Rep. Kingston running for the open U.S. Senate seat in Georgia, the opportunity in the district has drawn many interested parties to the race. Five Republicans have filed candidate paperwork, including two sitting state senators. As of now, there are no Democratic candidates. The Georgia primary is scheduled for May 20, with a likely run-off taking place on May 22. The AAO-HNS Government Affairs team will continue to follow these races closely in the coming months and will provide updated information as it becomes available. If you know of other otolaryngologist-head and neck surgeons running for state or federal office, please email us at govtaffairs@entnet.org. For updates on these races and others in your area, visit the Government Affairs Elections page at www.entnet.org/elections.
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Prepare for World Voice Day
Eager to celebrate World Voice Day (WVD), but not sure where to start? Then go to the Academy’s World Voice Day webpage at www.entnet.org/healthinformation/worldvoiceday.cfm. There you will find resources for physicians, patients, and media, including WVD event information and links to other voice-related websites. Introduction Otolaryngologist—head and neck surgeons and other voice health professionals worldwide join together to recognize World Voice Day each year on April 16. The international observance encourages people of all ages to assess their vocal health and take action to improve or maintain good voice habits. The American Academy of Otolaryngology—Head and Neck Surgery has sponsored the U.S. observance of World Voice Day since its inception in 2002. The Academy’s 2014 theme for WVD is Educate Your Voice. WVD Resources Resources found on the World Voice Day webpage include the official AAO-HNSF WVD poster that many members hang in their offices throughout the month of April, a WVD press release and local media outreach tips, and social media materials to help you spread the news about WVD on Facebook and Twitter. Voice Committee Members’ Bulletin articles and a running list of WVD media coverage are also available online. Last year CBS Local Radio, the Huffington Post – UK, the National Institute on Deafness and Other Communication Disorders (NIDCD) and several other institutions covered WVD. This year we hope to extend the coverage even further. Patient-Specific Resources If you have patients looking to learn more about the voice, our WVD page includes fact sheets as well as three different interactive activities. Found under the title “Voice Fact Sheets,” our list of fact sheets includes information about almost any common question, issue, or concern a patient could have about their voice. For the curious vocally healthy patient there is “About Your Voice,” “Keeping Your Voice Healthy,” and “Tips for Healthy Voices.” A patient who is experiencing vocal problems may find the following fact sheets to be helpful: “The Voice and Aging,” “Common Problems that can Affect Your Voice,” and “Hoarseness.” Finally, we have provided “Special Care for Voice Users” and “Effects of Medication on Voice” to help vocal professionals and teachers understand how to protect their main instrument. As a lighter way to help patients understand their voice and the importance of vocal care, our patient resource section includes three educational exercises. The first, “Rate Your Voice” is the Voice-Related Quality of Life (V-RQOL) Quiz. This is a quick ten-question quiz that has been adapted from the VocalHealthCenter of the University of Michigan’s “Voice-Related Quality of Life Measure” and is designed to help a non-physician quickly detect if his or her voice is in need of expert attention. Our “Identify Common Vocal Problems” quiz includes vocal samples to help the user learn what common vocal problems sound like. The vocal samples range from a normal child’s voice to a sample of spasmodic dysphonia. Our last exercise is geared toward vocal professionals and anyone about to participate in a vocally rigorous activity. We compiled a guide to eight simple warm-up exercises designed to prepare anyone for singing, public speaking, or any sort of potentially vocally strenuous event. WVD Events To see if there is an event near you, check out the WVD Events section of our World Voice Day page. Events listed will include those that we have been made aware of in advance such as a voice screening planned in Chicago, IL, and a WVD lecture for physicians and students in Hattiesburg, MS. WVD events range from screenings, lectures, and educational workshops to concerts and flash mobs. Related WVD Links Want more WVD information? Check out the list of domestic and international voice-related websites under “Join the World in Celebrating the Voice!” Be sure to visit www.entnet.org/worldvoiceday  and get ready to celebrate World Voice Day April 16!
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Oral Head and Neck Cancer Awareness Week
April 20-26 See materials to promote in your practice on the website at: www.ohancaw.headneck.org/setup.
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Voice Committee Members Speak About World Voice Day 2014
Can you comment upon the importance of voice in this era of social media? Lee M. Akst, MD Director, Laryngology; Johns Hopkins Medicine Department of Otolaryngology—Head and Neck Surgery As we get more connected through social media, communication becomes increasingly important in our social and professional lives. Much of this communication, even on social media, takes the form of speaking, particularly as we record and share videos with one another. As on the telephone, recorded voice on social media platforms is subject to technical limitations with clarity and volume—in that setting, it’s even more fundamental that voice be strong and clear so people can communicate effectively. Kenneth W. Altman, MD, PhD Professor of Otolaryngology; Director, Eugen Grabscheid MD Voice Center Director, Laryngology Fellowship—The Icahn School of Medicine at Mount Sinai One would think that the voice is used less in this era of computer-based communication, and texting input into Web-based social media. But this era also includes cell phones, an overall faster pace, along with faster and more continuous communication. Cell phones carry a particular threat to the voice, since we’re usually yelling into them next to loud trucks while jogging or into our Bluetooth devices in a loud car. Thomas L. Carroll, MD Director, The Center for Voice and Swallowing; Tufts Medical Center Without a doubt, in this era of social media, our ability as humans to communicate has officially transcended the routine need for vocal conversation. However, when we do communicate with our voices to another person by phone, video chat, or in person, inflection, emotion and personality typically provide the parties clearer and deeper meaning to the conversation.  Emoticons can never replace the voice’s ability to more completely express a person’s feelings, intentions, and emotions. Norman D. Hogikyan, MD Professor and Director, Vocal Health Center; Department of Otolaryngology-Head and Neck Surgery; University of Michigan There is no question that communication with the human voice has become more important in this age where there is widespread access to instant transfer of text, data, or images. The vast volume of information transferred via social media has so diluted the quality of most communications that the clarity and expressiveness of the human voice have in many ways become a welcome respite. I am also certain everyone has had the experience of needing a good “old fashioned” conversation to relieve tension or conflict generated by a misunderstanding via email, text, or post. Of course, there will never be a substitute for the beauty of the human singing voice. Michael J. Pitman, MD Director, Voice & Swallowing Institute; Associate Professor Department of Otolaryngology; New York Eye & Ear Infirmary Though a significant amount of communication today is via typed messages, voice remains the predominant mode of communication. That becomes obvious when a person is handicapped by laryngitis and has to struggle through a phone call, presentation, dinner, or drinks at a bar. We don’t realize how much we use our voices and how necessary they are, until there is an issue. In the future, technology will dramatically increase the importance of our voice as the keyboard goes the way of the typewriter and we “write” using voice recognition software. No more voice rest time. This year’s theme is Educate Your Voice; what does that mean to you? Dr. Akst: The most important thing anyone can do to keep their voice healthy is to “Know their Voice”—and educate themselves about their own voice. How does voice work? How should it feel when things are healthy and working well? What does it feel like if things are inflamed, or if you are abusing your voice? Knowing how your own voice should sound and feel can help you to recognize vocal disorders and can help a professional to treat your voice. Dr. Altman: Respecting your limitations. That means knowing how to shut it down when it sounds worse, and knowing how to use it more gently when you’re straining to get it out. If you’re a professional voice user under typical high stress of today’s business environment, then learning how to improve your vocal efficiency is critical. Dr. Carroll: To me, “Educate Your Voice” inspires all people who use their voice professionally to learn how to prevent vocal injury and maintain a healthy voice for a lifetime. Dr. Hogikyan: It is a reminder that you can learn to use your voice in a more healthy or effective manner. It also calls to mind the fact that voice and vocal health are vital to teachers and educators of all types. Dr. Pitman: Your voice is how you communicate and present yourself to the world. Educating your voice means teaching yourself to become aware of the role your voice plays in your life. What does it sound like? How is it perceived? Is it effective? It also means being aware of your vocal instrument. Is it functioning well? How can I keep it healthy? How can I use it in a safe and efficient manner and what do I do when a voice problem arises? Everyone gets hoarse from time to time. When should people worry about a voice problem? Dr. Akst: A great deal of hoarseness relates to laryngitis—self-limited inflammation of the vocal folds related to things like a virus, overuse, and reflux. This type of inflammation should typically go away within a few days or certainly within a few weeks. If hoarseness lasts longer than three weeks, particularly if it is interfering with someone’s ability to meet their social or professional voice obligations, they should consider a professional evaluation. If hoarseness lasts longer than three months, regardless of severity, there becomes concern for a lesion that should prompt otolaryngologic evaluation of the vocal cords. Dr. Altman: When they’re not prepared to meet their voice use needs, they tend to push through their limitations. That’s when you get into trouble with inflammation, edema, and lesions formation like vocal nodules or polyps. Persistent or worsening hoarseness, especially in patients with risk factors for cancer, should definitely be evaluated. Dr. Carroll: Hoarseness is not normal. In patients without risk factors for laryngeal cancer such as smoking, any hoarseness persisting longer than four weeks should be evaluated by an otolaryngologist. If a cause is not identified on initial exam, more specific tools such as videostroboscopy should be employed to identify the reason for the voice change. Dr. Hogikyan: Persistent hoarseness beyond two to three weeks without a known cause should be further evaluated, and particularly if associated with other symptoms such as trouble swallowing, pain, or shortness of breath. Smokers must be conscious of voice change due to the elevated risk of laryngeal cancer. Dr. Pitman: If a voice problem is of abrupt onset and severe, it could be due to a vocal hemorrhage. In such a case, people should go on immediate voice rest and see an otolaryngologist as soon as possible. This will allow confirmation of the diagnosis as well as appropriate and timely care.  Otherwise, we all have voice issues from time to time with infection or overuse. As long as symptoms resolve after a few days and do not recur regularly, there is nothing to worry about. In contrast, any voice problem that lasts longer than two weeks, especially in a smoker, is not normal and should be evaluated by an otolaryngologist. Katherine C. Yung, Assistant Professor of Clinical Otolaryngology-Head and Neck Surgery; University of California, San Francisco; Dept. of Otolaryngology-Head and Neck Surgery; Division of Laryngology People should consider further evaluation if the voice problem arises in the absence of associated illness, increased voice use, or other typical triggers for voice change. Additionally, even if there is a logical explanation for the change in voice, if it persists beyond a reasonable period (three to six weeks) then a closer examination is warranted. What is the role of the otolaryngologist in treating voice conditions? Dr. Akst: An otolaryngologist will begin evaluation for a patient with voice complaints by taking a thorough history and performing a physical exam. Often this exam will include endoscopy to provide an accurate picture of what the vocal cords look like during voice use. Following this evaluation, the otolaryngologist will reach a diagnosis concerning the cause of the voice difficulty, so a treatment plan can be created. Treatment for voice disorders may include medicine and surgery, and often includes vocal rehabilitation with a speech language pathologist as well. Dr. Altman: Evaluating the presence of a vocal lesion or paralysis is paramount, and could indicate a more serious life threatening condition. Skilled laryngologists identify subtle imperfections in the larynx, such as sulcus, and further identify surgical options. We treat medical conditions that can contribute to voice disorders, and have a unique understanding of the interdisciplinary contributions from other areas, such as gastroenterology, pulmonology, neurology, rheumatologic diseases, and others. Dr. Carroll: An otolaryngologist is essential in the diagnosis of voice conditions, but not always necessary for treatment. They often refer patients with voice complaints to speech-language pathologists (SLP) when a surgical procedure is not indicated or as an adjunct treatment when surgery is indicated. The otolaryngologist serves as one key part of the voice care team. Dr. Hogikyan: The otolaryngologist is the only medical practitioner trained to both diagnose and prescribe treatment for voice disorders. The subspecialist laryngologist takes this to another level, serving as consultant to other otolaryngologists, healthcare providers, or patients regarding voice disorders and their treatment. Dr. Pitman: Otolaryngologists are the primary physician for the care of voice conditions. Because of their specialized concentration on head and neck disorders, they are experts on the pathophysiology of the larynx and voice. In addition, they are uniquely trained to perform a laryngoscopy or videostroboscopy to visualize and evaluate vocal fold function. This knowledge and test are essential to obtaining an accurate diagnosis, which allows the prescription of efficient and effective treatment. Dr. Yung: Often voice conditions require a multidisciplinary team approach. The otolaryngologist is the head of this team and first performs a careful history and physical examination, including visualization of the larynx (laryngostroboscopy). He/she then confers a diagnosis and presents a treatment plan that may include behavioral management, medical therapy, and/or surgical treatment. The otolaryngologist performs the surgery, if necessary.
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Educate Your Voice
Norman D. Hogikyan, MD Professor and Director Vocal Health Center; Department of Otolaryngology-Head and Neck Surgery, University of Michigan The theme for our World Voice Day 2014 is Educate Your Voice. The word “educate” is typically associated with teaching or training of some sort, but how can this apply to voice? One way to educate your voice is to learn how voice is produced. The sound-producing structures in your voice box (larynx) are the vocal folds (also called vocal cords). These remarkable little parts of your anatomy vibrate many times a second to produce sounds that are then shaped by other portions of the throat, mouth, and nose into what we know as speech or song. Throughout the AAO-HNS World Voice Day website, you can find information and links to facilitate your voice education. What about the sound of your voice—is there a way to educate how your voice sounds? Another way to put that question is, “Can you learn to make your voice sound better?” The answer is a resounding yes! There is no doubt that voice quality impacts effectiveness of communication and how others see us. Even in a contemporary society that is actively engaged with social media, texting, and tweeting, first impressions may be based purely upon our voice. What do people think when they hear you? Make a recording of your own voice and listen to it by yourself or with colleagues and friends. What does it tell you? If you don’t like what you hear, you may want to be evaluated at a voice care center. Vocal health specialists can determine if there is anything wrong with your larynx itself, or if you are just not producing your voice optimally. Treatment can be tailored to your specific voice issues and results can be remarkable. This year’s World Voice Day theme is an important reminder of how vital the voice is to educators of all types, and to their students. Whether the classroom is traditional or virtual, live or recorded, it is difficult to imagine truly effective exchanges of information and ideas without voice. Teachers are perhaps the finest example of speaking vocal professionals, and even a minor voice problem can have a large influence upon the classroom. It is important for teachers, other occupational voice users, and for all of us that we take steps to maintain our vocal health. Make sure your vocal health education includes memorizing these tips: Don’t fail your voice by smoking. Learn to keep yourself well hydrated. Water is the best. Don’t scream or shout your way into vocal detention. Use a microphone if you need to project your voice. Take a vocal recess if you have laryngitis. Resting your voice will help it to heal. Be smart and get evaluated by an otolaryngologist (ear, nose, and throat physician) if you have persistent hoarseness.
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Out of Committee: Device Development: 1% Inspiration, 99% Perspiration and Regulation
Anand K. Devaiah, MD Adapted from a talk given to the New England Otolaryngology Society Meeting, December 2013, Yale University. Otolaryngology is a technology-driven field. This is well known to AAO-HNS members. Many of our advances as a field can be connected to our adoption and development of new technology. Everyone reading this article has designed, used, or benefited from a medical device in some way. Hence, it won’t surprise many of you to know that technology spending accounted for $331 billion globally last year1. Regardless of the depth to which you engage in medical devices, it is important to have a working knowledge of how one brings a device from idea to fruition. Certainly, for those who want to create new and better ways to help patients, this is obvious. However, it is key for the end-user to understand this, too. Why? We should all be aware of the process and where rules are imposed to provide measures of safety and regulation. Still not convinced? Have you attended a meeting or had a device manufacturer approach you to try its “newest thing”? You should be able to ask the right questions to assess the process by which that device came to be in your hands, at that moment, and certainly before it ends up in your clinic or operating room. Below is a way of framing these processes, but not certainly the only ways nor the only philosophies. Start the Process There are lots of ways to approach device development. It is usually best to start with a problem you encounter, which inspires you to wonder “If I only had something that did this…” Without the inspiration to fuel a drive for innovation, ideas remain ideas and will not often see the light of day. As one looks down the road at signposts for success, investors you may court to invest in your idea look at the passion behind the people and not just the idea. Design 101 Start with draft drawings of what you have in mind. This will often help you cement the device’s functions and form. It is helpful to search for existing devices that have been patented or are patent-pending. It is quite disappointing to go through the development process only to find that someone else has already done what you want to do. There are many ways to search for “prior art,” such as at the U.S. Patent Office (USPT.gov) and Google patents. It is important to note, and is apparent when you start searching patents, that intellectual property (IP) for devices can be difficult to protect. Making a few simple material changes can make a device “unique,” and may be difficult to keep your device protected. Alternatively, this could work in your favor if you can improve and differentiate your device from something that exists. Of course, you should adhere to the highest ethical standard in these efforts. Critically Appraise your Design It is easy to be enthusiastic about your idea, and you should be. However, it is tough to be critical about what you have designed. Ask questions of your idea. Does it accomplish what you want it to do? Does it change, for the better, how you and your colleagues accomplish the same task? Is it ergonomic? Can it be built? Do you think your market will accept this new idea? There are many others that you can and should consider, but these are a good start. Build a Prototype There are different ways to take your design to a prototype. For those who wish to work alone during this part of the process, there are a number of approaches. There are growing numbers of rapid prototyping facilities that use computer-aided design to create models. Rapid prototyping with 3D printing has become an accessible way to do this. Other methods include machine shop or other fabrication to build your prototype or working model. Depending on what you are designing, there are other options to consider. Funding Options to Move Your Project Along This can vary, based on your type of practice setting and resources available. For university-based practitioners, there are often internal mechanisms for technology development. This can include seed funding for projects, patent development, company development, and others. The U.S. government2 has a number of options that may fit your goal. This can include Small Business Innovation Research (SBIR), Small Business Technology Transfer (STTR), R21 grant mechanisms, and other ways. Industry partnerships are another way to move your project along. They can be involved at a number of points along the way to market. Other places to consider include foundations that may have funding mechanisms that may support a project in line with their goals. For larger projects where you may even consider building a company out of your idea, angel investors and venture capitalists may be a route to go. An interesting and growing mechanism is crowd-sourced funding (e.g., Kickstarter). Patent Basics There are three types of patents that you can apply for3,4: utility, design, and plant. Utility patents are granted for new and useful process, machine, article of manufacture, or composition of matter, or any new and useful improvement thereof. Design patents are granted for new, original, and ornamental design for an article of manufacture. Although not germane to this article’s focus, plant patents are granted for inventing or discovering and asexually reproducing any distinct and new variety of plant. An important distinction is that utility patents protect the way an article is used or works, while a design patent protects the way an article looks. Therefore, utility and design patents may be applied to the same invention. When applying, there are two basic patent protections to apply for: provisional patents and full patents. A provisional patent (i.e. “patent pending”) gives you a year of patent protection. During this time, you can have protection for your invention, and decide on whether you would want to get a full patent. A full patent gives you 20 years of protection from the date of issue, which ends up being about 17-18 years when considering the lead time to issuance. In 2011, the America Invents Act brought some changes to the patent system, which can be debated as to how sweeping these were or were not. Of interest is that there was a change from a “first to invent” to a “first to file” in regard to granting a patent; the first to file is given patent protection. If you are going to go international with your device, remember that international patent protection is important to consider, as a U.S. patent only protects you in the United States. Working with the FDA for Approval New devices require FDA approval before they can be used in practice5. There are two pathways for approval: 510K and the Premarket Approval Process (PAP). The 510K process is the overwhelmingly used method, and generally requires less background work for approval. It can only be used for devices that are a substantial equivalent to a previously approved device. The PAP is more rigorous, requires scientific studies of the device’s use, and is necessary for those devices that would not qualify under the 510K mechanism. The FDA has three classifications of devices: Class I (a “general control,” least regulated, exempt from PAP); Class II (general control with special control which is sometimes exempt); and Class III (general controls requiring PAP and the most tightly regulated). The time and cost required to bring devices to market varies, with greatest amounts for Class III devices, in general. Where Do We Go From Here? AAO-HNS members are encouraged to read more on the topics in this article, and others related to device development, for an in-depth discourse. Hopefully the information in this article helps answer many questions you may have about the processes and philosophies behind development. It should be clear to the reader why modifying Thomas Alva Edison’s quote to fit this article seemed to be most appropriate, with a most respectful nod to his genius. I hope that you will enjoy subsequent articles coming from the Medical Devices and Drugs Committee, as part of a newly launched series. References 1. Mosquera M. http://www.healthcarefinancenews.com/news/medical-devices-grow-3-percent-2012. Accessed Nov. 29, 2013. 2. USPT.gov. Accessed Nov. 29, 2013. 3. NIH.gov. Accessed Nov. 29, 2013. 4. Patent Pending in 24 hours. Stim R. and Pressman D. 1st edition. Nolo publishing, 2002 5. FDA.gov. Accessed Nov. 29, 2013. Anand K. Devaiah, MD, is Associate Professor of Otolaryngology, Neurological Surgery, and Ophthalmology, and the Chair of the Medical Devices and Drugs Committee for the AAO-HNS, and editor for the Bulletin article series from this Committee. Please feel free to direct any questions to him at anand.devaiah@bmc.org, or to the committee liaison, Harrison Peery (hpeery@entnet.org). Have a suggestion on a future article? Let us know! Relevant disclosures: Dr. Devaiah does not have a relationship with any commercial entities discussed in this article; he has owned financial instruments related to Google, Inc., which is a company mentioned in this article.
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New Endowment Fund Honors David R. Nielsen, MD
We are pleased to announce the establishment of a new endowment fund honoring the 12 years of service by David R. Nielsen, MD, as executive vice president and CEO of the American Academy of Otolaryngology—Head and Neck Surgery and its Foundation. The David R. Nielsen, MD Endowment is now open for contributions. At Dr. Nielsen’s request, the Fund will be used where needed most. In January 2015, Dr. Nielsen will complete his tenure as EVP/CEO, having served two full contract terms and agreeing to a third and final extension. “The Academy, its members, and the Foundation will benefit for years to come because of David’s vision and leadership,” said Nikhil J. Bhatt, MD, development committee coordinator. “We hope you will join us in honoring him.” One of the hallmarks of Dr. Nielsen’s service is his dedication to ensuring a strong Academy for generations of members to come. “When the next generation comes along, we don’t want to hand them today’s Academy, we want to hand them tomorrow’s Academy with the financial strength and the endowment necessary to allow us to provide exceptional patient care,” he said in 2012. “We want to make sure they have what they need to continue moving the Academy forward.” Donations can be made online at www.entnet.org/NielsenEndowment, or by contacting Ron Sallerson (rsallerson@entnet.org, 1-703-535-3775) or Mary McMahon (mmcmahon@entnet.org, 1-703-535-3717).
Susan R. Cordes, MD Vice Chair, BOG Legislative Affairs Committee
Find Your Voice
“My fellow Americans, ask not what your country can do for you, ask what you can do for your country.” As you read this quote, most likely in your head, you are hearing U.S. President John F. Kennedy’s voice saying those famous and moving words. The power of speech is incalculable; it is one of the main tenets of our constitution, and people have fought and died for it. As otolaryngologists, we are stewards of the human voice and World Voice Day (April 16) is a perfect time to remind ourselves and our patients of the importance of caring for those voices. This is also an ideal time to ask ourselves whether we are being good stewards of our own specialty voices. As primary stakeholders and advocates for our patients, physicians are the most appropriate individuals to address critical issues facing healthcare. But most likely, no one is going to come knocking on the door asking for our opinions; it takes some effort to make our voices heard. Fortunately, the Academy makes it easy for us. ENT Advocacy Network As practicing otolaryngologists, our day-to-day lives are affected by what happens in state and federal government. We have the opportunity to take an active role in educating members of Congress and state legislators on how proposed bills and regulations affect the practice of otolaryngology-head and neck surgery. As a member of the ENT Advocacy Network, you receive biweekly emails to keep you up to date on legislative issues, assistance with draft letters to members of Congress and state legislators, access to briefing materials on top legislative priorities, and assistance with hosting a state legislator in your practice if you desire. If you haven’t already signed up, it takes just minutes at http://www.entnet.org/Practice/members/entAdvocacyNetwork.cfm. In-District Grassroots Outreach (I-GO) Program Connecting with elected officials on their home turf is one of the most effective ways to advocate on behalf of our specialty. Through the I-GO Program, assistance is provided for hosting a legislator in your practice, arranging in-district office visits, attending a fundraiser, attending town halls, or writing a letter to the editor of your local paper. Email govtaffairs@entnet.org for information about these options. State Legislative Tracking The Academy has designated at least one representative otolaryngologist per state to receive daily legislative “tracking reports,” which detail specific actions taken by the legislature. In this way, trackers stay in tune with all state legislative activity and can notify their local or state society or the AAO-HNS regarding issues affecting the specialty, as well as follow national trends through monthly conference calls. To find out who your tracker is and learn more about the program, email govtaffairs@entnet.org. Social Media The AAO-HNS Government Affairs team has joined Twitter, Facebook, and LinkedIn. Participating in these forums provides updates on policies being considered on Capitol Hill and across the nation in state legislatures. The interactive nature of social media allows discussion of these important topics. Follow us @AAOHNSGovtAffrs. Meetings To see what the Government Affairs team is doing in person, attend advocacy-related events at the spring Leadership Forum and the annual meeting. Advocacy is ongoing, and Government Affairs Team members are available throughout the year; however, the semi-annual AAO-HNS/F meetings are a great opportunity to meet with team members in person. Between meetings, the team keeps otolaryngologists updated via social media, The News, the Bulletin, and the Legislative and Political Affairs page of the AAO-HNS website. Board of Governors The Board of Governors (BOG) serves in an advisory capacity to the Board of Directors on grassroots issues affecting the daily practice of otolaryngologists. The BOG is made up of representatives from local, state, regional, and national otolaryngology-head and neck surgery societies from around the United States. The BOG has Legislative Affairs, Socioeconomic and Grassroots, and Rules and Regulations committees. Any individual interested in grassroots affairs can participate in BOG activities. The best way to start getting involved with the BOG is to simply show up at a meeting, visit the website, or email bog@entnet.org. Different Strokes Individuals have varying levels of comfort with how to express their views. That is why the Academy offers so many options for making your voice heard. Explore those options and find the right medium for you. You won’t be sorry you took that step, and you can feel confident that you made your voice heard about issues that matter.
David R. Nielsen, MD AAO-HNS/F EVP/CEO
Our Voice: Extending Connectivity
On April 16, we will celebrate World Voice Day and participate in public and professional education focusing on understanding, appreciating, and caring for the human voice. You’ll see some advance preparation and material regarding this in this issue of the Bulletin. This is a great opportunity to reflect on the amazing capacity we have for communicating. It is far more than just using our vocal and auditory systems. Human communication is an incredibly complex and highly nuanced miracle. The study of anthroposemiotics (the word you drop at cocktail parties, if you are a voice specialist in the month of April, when asked what you do for a living) includes not only organizational and interpersonal communications, but body language, facial expressions, semantics, language, group and cultural dynamics, media, and much more. In our modern world, the heightened focus on and use of social media has added many new dimensions to what motivates, facilitates, and satisfies different levels of communication. The advancing technology of human communications not only serves our desires and needs, but increasingly drives what, why, and how (including how frequently) we share information, conduct our businesses, and expose our thoughts and ideas. From that perspective, the advances in connectivity, instant messaging, texting, audio, video, gaming, simulation, training, and teaching increase with such rapidity that it takes our breath away. But when compared with the intricacies and abilities of the human brain for speech, hearing, understanding, empathetic and emotional capacity, and our seemingly insatiable drive for advancing knowledge and the means of sharing it, the technology still has a long way to go. As we build complex systems and computers designed to approach human reasoning, reaction, and thought, with the vision of artificial intelligence, the center of the challenge remains how to organize the communications and sharing of thought and information. With that thought in mind, our stepwise attempts to include new communications technology in improving how we as the Academy and Foundation serve you can seem prosaic and pedestrian. Several years ago, a few courageous committees tried to engage through bulletin boards, group email lists, or committee webpages. But there was neither critical mass and demand from the committee members, nor the mobile supportive infrastructure, not to mention the as yet undeveloped desire for connectivity, necessary for them to succeed. Times are much different now. Committee work is much more advanced and active, basic and clinical science is more demanding, stakes are higher, the speed of policy development and change is greater, and demand for real time, mobile, curated access to information is much more urgent. In response, the Academy is not only engaged in social media, but improving its platforms to encourage and facilitate more effective use of your time as volunteers, committee members, and leaders. We are beta-testing our newly developed member portal, providing members the ability to customize their connectivity to the communities, committee members, content, and service opportunities in which they have interest. Currently, Boards of Directors, Executive Committees, Nominating Committee, Ethics Committee, staff, and select volunteer committees are conducting their data and information sharing and portions of their deliberations and discussions online. Early experience suggests that participants are better prepared for decisions and are making better use of their time prior to face meetings, conference calls, or webinars. A few years ago, only a handful of committees or work groups met more than a couple of times each year. Today, more than a dozen already meet quarterly or monthly, and dozens more are carrying on many deliberations between face-to-face meetings at the Annual Meeting. Even our unifying specialty-wide committees and groups have more to share and more frequent need for a platform to which members can refer in preparation for upcoming events. Groups such as the Guidelines Task Force (GTF), Centralized Otolaryngology Research Effort (CORE), Board of Governors (BOG), and the Specialty Society Advisory Council (SSAC) are examples of such unifying groups. Several other committees, including the leadership mentioned earlier in the column, are posting minutes for review, committee agendas, and background reports and materials in preparation for meetings. More can be accomplished with less time away from home, fewer travel costs and hassles; and more satisfying experiences can be had in participating in collective work. When the time comes, we hope you will use the new Member Portal, develop your profile on the site, work within your groups and committees, and share in our desire to improve communications and the work of the Academy for the benefit of our members and their patients.
Richard W. Waguespack, MD AAO-HNS/F President
Educate Your Patients and Extend Your Voice
“Doctors with better communication and interpersonal skills are able to detect problems earlier, can prevent medical crises and expensive intervention, and provide better support to their patients. This may lead to higher-quality outcomes and better satisfaction, lower costs of care, greater patient understanding of health issues, and better adherence to the treatment process.” 1 In the February Bulletin page devoted to quality and safety, Rahul K. Shah, MD, stated, “…the literature certainly supports that an optimized patient experience drives overall quality and is a surrogate for safety within an organization.” Importantly, he continued, payers and others are using patient satisfaction as a stand-alone quality measure in some cases, linking patient satisfaction directly to at-risk compensation to ensure it demands high attention. And Dr. Shah’s key takeaway was that efforts to improve patient care must be prioritized in the ongoing search for safety, quality, and satisfaction. And, yes, the order of this list reflects the priority we have to give each element. He concludes by suggesting that the solutions for finding the balance needed may come from members themselves with the support of the society structure. As practitioners the problem is not new to us. We fully recognize the obligation to obtain informed consent, for instance, from patients before a procedure is performed.2 However; there are many other points along the care continuum that would benefit from more attention and lead to better patient satisfaction. The truth is, of course, we cannot give each patient unlimited attention and time, as we strive to provide optimal medical care and document our doing so. Take home information complements what is said during the encounter and helps the patient recall critical information and focus on additional or unanswered concerns. Being able to re-read critical portions of the discussion and instructions may alleviate unrecognized aspects the patient missed during the intensity of the visit as well. Such information, and that given by your staff, leverage the face-to-face time spent during a visit, especially when patients are encouraged to contact your office with additional questions and concerns. Another way to balance the demands of safe and quality care is to use tools organizations like the Academy offer. Lack of time and resources for promotion of good health measures a real limitation of a busy practice, so incorporation of campaigns supported by the Academy and like-minded organizations promotes quality and patient satisfaction. Health Observations in April The AAO-HNS and its committee structure support several health observations each year, developing tools that extend communication time with our patients. Two such opportunities occur in April: World Voice Day and Head and Neck Cancer Awareness Week. Since the January Bulletin focused on Head and Neck Cancer Awareness information via OHANCAW from the Head and Neck Cancer Alliance; I will highlight World Voice Day. World Voice Day is unique in that it is truly a global effort. Web searching its title proves this. The original logo design that developed in Brazil still depicts a meaningful image. The Academy and specifically our Voice and the Media and Public Relations Committee Chairs Clark A. Rosen, MD, and Wendy B. Stern, MD, are central figures for the U.S. observation. Norman D. Hogikyan, MD, of the University of Michigan, has steadfastly worked within the Voice Committee for several years to craft its Voice Day focus, which is presented on page 15. On pages 20 and 21, the Academy’s own downloadable theme poster appears with additional members of the Voice Committee giving their perspectives on the observation including tips to share with patients and other interested parties. Each year’s new offerings form collections of useful patient information that become an enduring library. Members of the AAO-HNS Media and Public Relations Committee offer some examples of how they have used these tools successfully: Dr. Stern, with the AAO-HNS Media and Public Relations Committee, shared how she’s used these tools successfully. “Celebrate World Voice Day in your own backyard. Our practice of otolaryngologists and speech language pathologists teams up with our local singers, poets, performers, DJs and politicians every year and hosts an evening celebration of the voice. We feature the Academy’s theme for the year. We present informative information regarding the mechanics of voice and how to keep it healthy interspersed with entertainment. It turns out to be a fun-filled and educational community event. With a little planning it is easy to do and the community loves it.” See additional WVD resources and ideas from C. W. David Chang, MD, at www.entnet.org/HealthInformation/WorldVoiceDay.cfm. References 2.  Fong J H, Longnecker N, Doctor-Patient communication: A review. Ochsner J. 2010 Spring; 10(1): 38-43. 3.  Enzenhofer M, Bludau HB, Komm N, et al. Improvement of the educational process by computer-based visualization of procedures: randomized controlled trial. J Med Internet Res. 2004;6(2):e16  [PMC free article].