Published: June 3, 2014

Association of Otolaryngology Administrators

What Every Otolaryngologist Needs to Know about the Open Payments Program (Sunshine Act)

Robert M. Portman, JD, MPP* The Physician Payments Sunshine Act (PPSA or Sunshine Act), now being implemented as the Open Payments program, is upon us. The primary purpose of the program is to shed light on the financial ties between the healthcare products industry and physicians. Most physicians know this law is going to require public reporting of their financial relationships with drug and device companies, but many doctors have less than a full picture of what the law requires and how it will affect them. This article summarizes the key provisions of the final PPSA rules that were issued in 2013 by the Centers for Medicare and Medicaid Services (CMS) and provides answers to frequently asked questions about the Open Payments program. While the final rule covers the reporting obligations of both manufacturers and GPOs, this article will focus only on the obligations of manufacturers. Much more information about the program can be found at the Open Payments website at go.cms.gov/openpayments. Summary of Final Rule The PPSA rules impose two types of reporting requirements on “applicable manufacturers,” defined as those companies that manufacture a Medicare, Medicaid, or Children’s Health Insurance Program (CHIP)-covered drug, device, biological, or medical supply and whose products are sold or distributed in the United States. First, they require any applicable manufacturer to report transfers of value to a physician or teaching hospital, which the final rule refers to as “covered recipients.” Second, applicable manufacturers are required to report separately any physician ownership and investment interests and payments of value to physician owners, investors, and immediate family members, including spouses, children, parents, siblings, and other close relatives (but note that the names of family members do not need to be reported, just the physician’s name). This includes physicians with an ownership interest or stock with an applicable manufacturer, regardless of the amount, but only where the manufacturer is aware of such ownership interest. Failure to adhere to these reporting requirements may result in civil monetary penalties for manufacturers. The final rule requires manufacturers to report a transfer of anything of value to a covered recipient, regardless whether it was requested, to a physician or teaching hospital. “Anything of value” includes: Cash or cash equivalents Space rental or facility fees In-kind items or services Stocks, stock options, or any other ownership interests, dividends, profits, or other returns on investments The rule outlines a number of exclusions from the reporting requirements, including but not limited to: Transfers of value of less than $10 unless the aggregate amount over a year exceeds $100, with an exception to the aggregation requirement for pens, notepads, and other de minimis items provided at conferences or other large scale events; Product samples intended for patients; Educational materials that directly benefit patients; Discounts or rebates; Payments to speakers and tuition discounts for attendees at certain accredited CME events; and In-kind items for charity care Applicable manufacturers must report the name, date, NPI, state license number, specialty, and address of the entity or individual receiving the payment to CMS. The report must specify the amount of the payment, the nature of the payment (such as consulting fee, food, entertainment, travel, education, or research), and the form of payment (such as cash, stock, stock option, or in-kind items or services). Once the data is submitted to CMS, the agency aggregates and sorts it by individual covered recipients and provides them with 45 days to review and dispute manufacturer reports and another 15 days for manufacturers to submit corrections. CMS will publish the reports in a publicly searchable database on the Open Payments website with the individual physicians’ names and information and whether the report is disputed. Frequently Asked Questions about the Open Payments Program Scenario EXAMPLE. What kinds of final relationships with manufacturers are reportable? The Sunshine Act covers virtually any kind of direct or in-kind remuneration from a manufacturer to a physician or teaching hospital, including: Consulting fees Compensation (services other than consulting, includes serving as faculty or as speaker at an event other than a continuing education program) Honoraria Gifts Entertainment Food and beverage Travel and lodging Education Text books and journal reprints Research Charitable contributions Royalty or license Current or prospective ownership or investment interest Compensation for serving as faculty/speaker for unaccredited and non-certified continuing education program Direct compensation for serving as faculty/speaker for accredited and certified continuing education program Grants Space rental or facility fees (teaching hospital only) Stock or stock options Scenario EXAMPLE. If a manufacturer pays for lunch at our group practice, but I don’t attend or don’t eat the food, will I still be reported? No, only those who attend and partake of the meal will be reported—assuming that the meal is more than $10 in value. The value of the meal must be calculated on a per-person basis, including all attendees, not just physicians. Scenario EXAMPLE. I’ve heard that if I eat a meal at an industry-sponsored AAO-HNS/F meeting or receive an AAO-HNS/F research grant funded by a drug or device company that my name might be reported to CMS, is that true? Yes, the Sunshine Act requires manufacturers to report indirect transfers of value to physicians through third parties, like medical societies, when the manufacturer directs, instructs, or otherwise causes the medical society or other organization to provide the payment to the physician and the manufacturer knows or easily could ascertain the identity of the physician recipient(s). If a manufacturer sponsors a dinner at the AAO-HNS/F Annual Meeting, the per-person value of that dinner would have to be reported for all of the physician attendees. Likewise, if a manufacturer funds a research grant that is administered by AAO-HNS/F to be awarded to an AAO-HNS physician member, the value of the grant would be reportable for the physician awardee. By contrast, if the manufacturer gives AAO-HNS/F an unrestricted grant for the Annual Meeting, (i.e., without specifying how the money should be used), and AAO-HNS/F decides to use some or all of those funds to subsidize a dinner at the Annual Meeting, that would not be reportable because the manufacturer did not cause the funds to be used to transfer something of value to physicians. [Cautionary note: some manufacturers are taking a very conservative interpretation of the Open Payments rules and are saying they will report even unrestricted grants if they learn that the money was eventually used to make indirect transfers of value to physicians and they can easily identify the physician beneficiaries; even though they did not cause the funds to be transferred to a physician.] Similarly, an industry-funded lunch buffet in the Annual Meeting exhibit hall would not be reportable because it would likely constitute a “large-scale event” for which the identity of the physician beneficiaries could not be easily ascertained. Payments to physician faculty and tuition discounts for attendees of manufacturer-funded CME are not reportable if the event is accredited by, among others, the Accreditation Council for Continuing Medical Education, the American Medical Association, the American Osteopathic Association, or the AmericanAcademy of Family Physicians. Under this exception, the manufacturer also may not have any role in picking speakers or content and cannot pay the faculty or attendees directly. This exception would not cover any meals or other kinds of transfers of value provided to the attendees of accredited CME events. Scenario EXAMPLE. Is AAO-HNS/F required to provide my name and other information to industry sponsors if I receive an indirect transfer of value through the Academy or Foundation? Technically, medical societies like AAO-HNS/F are not covered by the Sunshine Act and therefore do not need to provide information to industry about indirect transfers of value to their physician members. But, future industry funding is likely to be conditioned on such cooperation; and if AAO-HNS/F does not provide the information, manufacturers will report based on their best guess of the identity of the physician recipients and the value of the benefit. This could lead to wildly inaccurate reporting by industry and cause even bigger problems for AAO-HNS members. Scenario EXAMPLE. Can I avoid being reported by redirecting payments to charities or friends and family? No, if a physician redirects an industry payment to a family member, friend, or favorite charity, the law still requires the manufacturer to report the payment as if it has been made to the physician directly. However, the third party does not need to be reported. Scenario EXAMPLE. Will I have a chance to review and dispute reports about me? Yes, as noted above, the Open Payments program gives physicians a 45-day window to review and dispute reports about their financial relationships with, or ownership interests in, manufacturer companies. During this period of time, the physician can contact the manufacturer and try to persuade the company to change or remove the report. The manufacturer then has 15 days to correct the report. But, if the manufacturer refuses to do so, CMS will only mark the report as disputed; it will not remove it or otherwise arbitrate the dispute. Scenario EXAMPLE. When are these reporting requirements effective? Manufacturers were required to start collecting data as of August 1, 2013 and needed to submit data through December 31, 2013 to CMS by March 31, 2014. The Open Payments public database goes live on September 30, 2014. In future years, the website will post reports by June 30 for the previous year’s data. Scenario EXAMPLE. What can I do to protect myself from inaccurate reports or explain my industry relationships to patients? Physicians and their practice groups should track and retain their own records of items of value received from manufacturers to ensure they are prepared to evaluate and challenge the accuracy of reports that include them. (Note that the Open Payments website is offering a mobile app to assist physicians in tracking their industry relationships.) With only a 60-day period for dispute resolution and no independent review, physicians need to respond quickly to improve the chances of resolving discrepancies. Failure to resolve a dispute will lead to publication of a manufacturer’s report “as is,” albeit in some cases with a note that the report is disputed. But physicians will have no opportunity to publish an explanation of their position. CMS recommends that all covered recipients register on the agency’s website. Registration supposedly will ensure that CMS will notify physicians in a timely manner after the manufacturer submits a report so that the physician will have an opportunity to check to see if his or her name has been included and, if necessary, dispute the report. CMS will not notify physicians when their particular name has been reported. It will be up to each physician to search the database for their name or NPI number. In this regard, it will be critical that CMS and manufacturers have the physician’s current name and NPI number to avoid inaccurate reports. Physicians would also be well advised to develop talking points to use in responding to questions from patients, colleagues, and, in some cases, the media, about their industry relationships. They may also want to preempt such questions by putting information about their relationships with industry on their practice website or in other patient communications. Robert M. Portman, JD, MPP, is an association and healthcare attorney with Powers Pyles Sutter & Verville PC in Washington, DC. He also serves as legal counsel for AAO-HNS/F. This article is provided for informational purposes only and does not constitute and should not be treated as legal advice.

State Legislative Sessions Adjourning

With most of the 2014 state legislative sessions winding down, the AAO-HNS thanks its member-volunteer “state trackers” for their stellar job in monitoring legislative issues important to the specialty. However, it’s never too early to begin preparations for 2015! Join the growing team of AAO-HNS state trackers by emailing the Government Affairs team at govtaffairs@entnet.org.

ENT PAC

2014 is an election year for Congress, with many primaries already concluded! ENT PAC, the political action committee of the AAO-HNS, financially supports federal Congressional candidates and incumbents who help and/or advance the issues important to otolaryngology–head and neck surgery. Since your AAO-HNS annual dues cannot be used for political purposes, ENT PAC was established to accept voluntary contributions enabling our members to speak with a collective voice. ENT PAC is a NON-PARTISAN, ISSUE-DRIVEN entity that serves as your collective voice on Capitol Hill to increase the visibility of the specialty with key policymakers. To learn more about ENT PAC, visit our PAC website at www.entpac.org (log-in with your AAO-HNS ID and password) or email entpac@entnet.org for assistance. .

Audiology-related Legislative Landscape Takes Shape

Opposition to federal legislation designed to inappropriately expand the scope of practice of audiologists has long been one of the AAO-HNS’ key legislative priorities. For years, the national organizations representing the audiology community sought passage of federal legislation that would provide audiologists with unlimited “direct access” to Medicare patients without a physician referral. However, in late 2012, we learned the audiology community was no longer coalesced around the direct access issue, and the three groups representing audiologists would instead pursue separate legislative initiatives. As expected, dueling pieces of audiology legislation have been introduced in the 113th Congress, with yet another bill on the horizon. They are: American Academy of Audiology (AAA)—H.R. 4035/S. 2046, a recycled bill to provide audiologists with unlimited direct access to Medicare patients without a physician referral. Introduced in February 2014 by Rep. Jim McDermott (D-WA) and Sen. Sherrod Brown (D-OH). AAO-HNS opposes. American Speech-Language-Hearing Association (ASHA)—H.R. 2330, a bill designed to align Medicare coverage of comprehensive audiology services with current billing and reimbursement standards of other non-physician therapeutic services covered by Medicare (PT, OT, SLP). This bill specifically retains the requirement for a physician referral, as well as physician oversight of plans of care. Introduced in June 2013 by Rep. Gus Bilirakis (R-FL). AAO-HNS supports. Academy of Doctors of Audiology (ADA)—Legislation not yet introduced. Expected to move forward with its new “18 x 18” campaign—an effort to pass legislation by 2018 that would amend Title XVIII (18) of the Social Security Act to include audiologists in the definition of “physician.” This new initiative would also provide direct access similar to the AAA legislation and the comprehensive benefits outlined in the ASHA proposal. AAO-HNS will oppose. The shift in the audiology community’s strategy is not an anomaly. Since passage of the Affordable Care Act and the President’s subsequent reelection, there has been a slightly more favorable environment on Capitol Hill regarding efforts to expand access to non-physician healthcare providers to help fill perceived gaps in care. Given these evolving legislative “environment” variables, and the strategic shift within the audiology community, the AAO-HNS has remained proactive in its approach to ensuring Members of Congress (and their staffs) are well educated on the various audiology initiatives. In addition to several AAO-HNS letters to Capitol Hill and numerous meetings with legislative and committee staffs, the Academy spearheaded two coalition sign-on letters opposing the direct access effort (H.R. 4035/S. 2046). We are pleased to report that nearly 110 national, state, and local medical societies—including the American Medical Association and the AmericanCollege of Surgeons—are signatories to our letters. Thus far, our efforts have received a positive response from many Capitol Hill offices. However, our success should not breed complacency. The AAO-HNS urges its members to follow these issues closely. As these legislative efforts continue to unfold, applicable legislative “action alerts” and other advocacy-related materials will be communicated to AAO-HNS members. For more information regarding audiology legislation in the 113th Congress, contact legfederal@entnet.org. Or, visit the Legislative and Political Affairs webpage at www.entnet.org/advocacy for access to the Academy’s position letters and/or additional resources pertaining to these issues.

Timeline of SGR Repeal Activities

February 2013 House Energy & Commerce (E&C) Committee conducts hearing on SGR issue. House Ways & Means (W&M) Committee staff briefs physician community on development of SGR legislation. Congressional Budget Office (CBO) reduces cost estimate for SGR repeal. May 2013 House W&M conducts hearing to collect information on potential reform proposals. Senate Finance Committee solicits feedback from physician community regarding future of fee-for-service system. House E&C briefs physician community on “framework” for SGR repeal legislation. June 2013 House E&C releases revised SGR framework. July 2013 House E&C conducts markup of SGR bill and unanimously votes to advance the proposal. October 2013 Senate Finance and House W&M release legislative framework to repeal the SGR formula. November 2013 Staff for Senate Finance and House W&M brief physician community on legislative framework. December 2013 Senate Finance conducts markup of SGR framework; approved by Committee. House W&M conducts markup of SGR legislation; approved by Committee. Two-year budget deal signed into law; includes three-month SGR “patch.” February 2014 Bipartisan, bicameral legislation (H.R. 4015/S. 2000) to repeal the SGR formula and reform the Medicare physician payment system introduced in Congress. Senate Finance Chairman Max Baucus (D-MT) departs U.S. Senate and is replaced by Sen. Ron Wyden (D-OR). March 2014 H.R. 4015 passed by U.S. House of Representatives (March 14) with partisan offset. U.S. House passes 12-month SGR patch (March 27) via vote voice. U.S. Senate passes (64-35)12-month SGR patch (March 31). April 2014 President signs 12-month SGR patch (April 1).

See What All the Tweeting Is About—Follow the Government Affairs Twitter Account

Want to be one of the first to know what’s happening on Capitol Hill? If so, sign-up for Twitter and follow the Government Affairs account @AAOHNSGovtAffrs. You’ll receive daily updates on legislative and political issues impacting the specialty, your practice, and your patients. Get “insider” knowledge on matters such as repeal of the flawed Sustainable Growth Rate (SGR) formula, scope-of-practice battles, and Graduate Medical Education (GME) funding. Also, check out our Twitter scroll at www.entnet.org/advocacy for our latest tweets.

Opportunity Knocked, But Congress Did Not Listen

Are you tired of hearing about the “SGR” yet? By now, the answer is probably “yes.” The SGR, or Sustainable Growth Rate, formula used to determine payments to physicians in the Medicare program is the proverbial “thorn in the side” federal legislative issue for physicians. For more than a decade, the physician community has urged Congress to permanently repeal the flawed formula, and this spring was supposed to be “the time.” Unfortunately, Congress (again) lacked the political will to make this generally despised issue disappear. Read on for an overview of the past, present, and future outlook for ridding the House of Medicine of this flawed formula that continues to wreak havoc on physicians and patients within the Medicare program. Past: What is the SGR and Where Did It Come From? The SGR became law as part of the Budget Control Act of 1997, and was intended to act as a mechanism to ensure that the yearly increase in the expense per Medicare beneficiary did not exceed the growth in GDP (gross domestic product). However, one inherent flaw of the formula is that it assumes a positive correlation between the GDP and Medicare spending. So, in a strong economy, GDP and spending would theoretically grow at a similar rate and payments would remain positive. However, in a weaker economy, when spending exceeds the GDP, the formula is designed to trigger reductions in Medicare physician payment rates. The triggered reductions came to fruition in the early 2000s and have resulted in an annual exercise of intense lobbying from the physician community to spur Congressional action to prevent (usually at the last minute) the payment cuts. Congress has prevented scheduled cuts from going into effect each year except for 2002, when physicians absorbed a nearly five percent cut in their Medicare payments. Compounding the complexity of this issue is the cumulative nature of each year’s scheduled cut. In basic terms, Congress’ proclivity for short-term remedies for this long-term problem means that with each year’s payment “patch,” the percent of the next year’s cut, and the estimated cost of repealing the formula, grows. Present: The “Stars Aligning” (February 2013 through Spring 2014) Since the SGR emerged as an annual issue for Congress, there has been broad (and growing) bipartisan support for permanently repealing the flawed formula. However, two issues have regularly been blamed for thwarting these efforts. First, lack of agreement from the physician community regarding what type of payment policy should replace the SGR. Second, simply put, cost. Despite these challenges, the “stars began to align” in early 2013 (see box next page), and it became widely believed that the year that the SGR issue would finally—and permanently—be resolved had arrived. First, leaders from the Congressional committees with jurisdiction over Medicare collectively stated in early 2013 that repealing the SGR formula would be their top priority for the year. These statements spurred an ongoing dialogue between Capitol Hill and the physician community in order to craft, and eventually coalesce around, a new payment model designed to better incentivize the delivery of high-quality, efficient healthcare. Around the same time, the Congressional Budget Office (CBO) released an updated projection of the estimated cost of SGR repeal—reducing the amount to $138 billion during 10 years. Previous estimates had scored SGR repeal at more than $300 billion. Throughout the remainder of 2013, efforts to repeal the SGR continued. By year’s end, the House Energy and Commerce (E&C), House Ways and Means (W&M), and Senate Finance Committees had each unanimously passed versions of the SGR repeal policy that had evolved with input from the physician community, and lawmakers agreed they would likely only need a couple of more months to finalize offsets for the permanent package. As a result, Congress passed an amendment to the Bipartisan Budget Act of 2013 to halt (for three months) the 24 percent cut in Medicare physician payments scheduled for January 1, 2014. Instead, physicians received a .5 percent positive increase during that time. This payment “bridge” was intended to avoid payment disruptions as Congress completed its work on permanent SGR repeal legislation during the first several months of 2014. Initially, it seemed as though Congress was poised to keep its word in terms of continuing to work on the SGR issue in the new year. In February, the aforementioned Congressional committees announced they had successfully negotiated the “melding” of the policy included in their respective SGR bills and that conversations to identify the necessary offsets for the bill could/would begin. Unfortunately though, the introduction of the finalized bill coincided with the departure of one of SGR repeal’s key champions, Senate Finance Committee Chairman Max Baucus (D-MT). Ultimately, Chairman Baucus’ departure (to become Ambassador to China) acted as a double-edged sword for ongoing SGR efforts. It spurred the final bill to be introduced, but it also delivered a serious blow to the momentum needed to actually achieve final passage of a bipartisan, bicameral permanent SGR repeal package (H.R. 4015/S. 2000). In the weeks following, the necessary offset negotiations failed to materialize and leaders in the U.S. House of Representatives opted to put forth a partisan offset (delay of the ACA individual mandate) as the key funding for H.R. 4015, and passed the bill on March 14. While many lawmakers argued their strategy was simply to pass the bill from the chamber, the partisan politics slowed action in the U.S. Senate. Dueling bills were subsequently introduced in the upper chamber, using equally partisan offsets. As a result, the likelihood of permanent repeal by the March 31 deadline began to fade, and Congressional leaders began preparing a 12-month SGR patch, the decade’s 17th temporary fix. In an unprecedented move, the physician community, including the AAO-HNS, reacted to the Congressional leadership’s “bait and switch” by actively opposing the proposed 12-month patch, and instead urged lawmakers to continue work on the policy agreement that had previously been negotiated. Unfortunately though, House leaders ignored the pleas from the physician community, and on March 27 resorted to unprecedented stealth floor tactics to force a voice vote on the patch and avoid an “on the record” vote tally. The U.S. Senate followed suit on March 31, passing the temporary SGR bill by a vote of 64-35. The President signed the bill into law soon thereafter. Future: Hard to See an Immediate Path Forward Despite Congress’ claim that the large price tag (currently about $150 billion) associated with permanent SGR repeal remains its greatest roadblock, the fiscal reality is that the total price of all the SGR patches to date exceeds the cost of permanent repeal. And, another patch only increases the price of any future effort to permanently repeal the flawed SGR formula. Most importantly, the length of the negotiated patch seriously diminishes the likelihood of permanent repeal in the near future. Although Congressional leaders claim efforts to permanently repeal the SGR formula can still be advanced in the coming months, several variables—mid-term elections, a lame duck Congress, followed by potential leadership changes in the 114th Congress—raise serious doubts about the viability of advancing a permanent package before another patch would be necessary in March 2015. The AAO-HNS is extremely disappointed with the inability of Congress to deliver on its promise to seek bipartisan offsets for the permanent SGR bill. Congress missed a critical opportunity to—finally—provide stability for the nation’s seniors and physicians participating in the Medicare program. Interested in more information? Contact legfederal@entnet.org with specific questions regarding the process and policy outlined above. In addition, visit the Legislative and Political Affairs webpage at www.entnet.org/advocacy to view the Academy’s SGR comment letters and/or additional information about the negotiated policy to repeal the SGR.

Candidate Statements: Nominating Committee Academic

What do you see as the priorities of the Nominating Committee in selecting the future leaders of our Academy? C. Gaelyn Garrett, MD We are in the midst of exciting yet daunting changes in medicine. As physicians, we should be leading the charge to insure that these changes positively impact our primary goal of providing the highest standards of medical care to our patients. The American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS) is uniquely positioned to provide the resources and support to accomplish this goal. The strength of the AAO-HNS is clearly its fellow members; as a member of the Nominating Committee, I will seek leaders who are forward thinkers and motivators of the membership to foster the relationship between clinicians and policymakers. Rather than be stymied by these challenges, our leaders will embrace the opportunities to build on what is successful and redirect what is not. With that positive relationship, the AAO-HNS can continue to be our advocate for advancing our primary missions of patient care, education and scientific innovation. We are physicians first—but we need to recognize the necessity for expanding our influence beyond the clinical realm. Our future Academy leaders will continue to help us lead this charge. Stacey L. Ishman, MD, MPH I believe we must select physician volunteers who have a commitment to service, an understanding of the issues affecting medicine, and the integrity and passion to carry out this important work. Our academy is blessed with a multitude of talented and collaborative members and it is the job of the Nominating Committee to select the best of this gifted group. I feel that an ideal candidate should have the vision to continue our Academy’s national leadership on quality and patient outcome efforts while remaining aware of the diverse perspectives that are necessary to represent our broad constituency. My experiences in the Academy have helped me to understand effective leadership qualities. I have been highly involved in the Board of Governors and currently serve on the Executive Committee as the Member-at-Large. I have been a member of multiple Academy committees as well as the Advisory Council for Quality and the Guidelines Development Taskforce. I have also served locally as the President of the Maryland Otolaryngology Society and Surgical Director of a multidisciplinary UpperAirwayCenter at Cincinnati Children’s Hospital. I would appreciate the opportunity to use this knowledge and serve my fellow otolaryngologists as a member of the Nominating Committee. Albert L. Merati, MD Future AAO-HNS leadership must recognize and address evolving trends in membership as the next generation of otolaryngologists is increasingly likely to self-identify as subspecialists. The future leaders of the AAO-HNS must understand what will always be the heart of otolaryngology practice—the general otolaryngologist—but also recognize that the nature of the membership is changing. Otolaryngology program graduates (naturally the largest growth area for AAO-HNS membership) are increasingly likely to pursue fellowship training and enter group practices as their designated “ear” person or “nose” specialist. Already happened in your practice? Or the practice down the street? The AAO-HNS will be affected by this trend: our capacity for patient and practice advocacy depends on preserving meeting and membership revenue. The budget choices made by leadership will reflect the needs and demands of paying members. If the growing group of self-identified subspecialists loses the sense of connection to the AAO-HNS as a group, our power to make the positive impact as outlined in our mission will be compromised. As a member of the Nominating Committee, I will use my experience connecting with thousands of members in practices all over the U.S. to help keep all members in mind while submitting names for election. Rodney Taylor, MD, MSPH The task of the Academy’s Nominating Committee is to provide a dynamic roster of the best individuals for its members to select a leadership team that can harmoniously navigate the Academy through our current and future challenging environment. The responsibility of selecting our leaders is second only to actually providing the leadership that will be essential to the ongoing success of our Academy. The navigators of our Academy should be bright and sympathetic individuals who are uniquely passionate and engaged in providing guidance for a subspecialty of surgeons widely considered among the most talented and well-rounded physicians in medicine. Our leaders should distinguish themselves for outstanding character, vision and integrity; individuals who unhesitatingly demand justice with a clarion voice, and have the experience to represent the compelling interests and wonderful diversity of our wide-ranging members. If I am elected for this crucial role, I will be dedicated to providing a leadership roster that will be the most capable and committed group to direct our Academy going forward.

Candidate Statements: Director at Large Academic

Given the uncertainty of today’s healthcare environment, what do you perceive as challenges and possible solutions to implementing the Academy’s strategic plan? Carol R. Bradford, MD There is no question that our members are facing unprecedented challenges in today’s healthcare environment. The era of healthcare reform, the intrusion of the electronic medical record, and the fear of changing models for reimbursement all seem to threaten the ideals we hold dear: our commitment to deliver the best patient care and our aspiration to improve the health of all people suffering from ear, nose, and throat diseases. It is clear that our future success is dependent upon our collective ability to deliver and measure value (outcomes/cost). Our Academy is well positioned for this future with its advocacy for relevant and validated quality and cost measures and its efforts to develop guidance about value-based purchasing and meaningful use of the EMR, among many other efforts. It is essential that the AAO-HNS remain proactive in addressing the rapid pace of the changing healthcare environment and serve its members by advocacy, quality, and educational efforts. If elected, I aspire to be a servant leader. I will listen and serve the robust membership of this society in order to allow us to reach our vision of empowering otolaryngologist-head and neck surgeons to deliver the best patient care. Cherie-Ann Nathan, MD This is a stressful time for our members with the looming perfect storm of ACA, ICD-10, and pay-for-performance. Never before in the history of our profession have so many changes occurred in so many areas in so short a time. I am honored by this nomination and will help the Academy rise to the challenge of helping our members cope with these dramatic sea changes. Using my leadership experience gained by serving on numerous national committees not only in the Academy, but also the AHNS, ASCO, NCI Task Force, and HNCA, I believe I can help the Academy navigate us through these difficult times in the following areas: Best practice guidelines, outcome measures, consensus statements Understanding and implementing ICD-10 Preparation for ACA and pay-for-performance Customized educational activities Real-time mobile app updates Supporting research to publish studies that will help guide best practices I would encourage the board to give monthly updates on each problem area: ACA/ICD-10, best practice guidelines, fiscal issues, and cutting-edge information. Having been on CORE, I would promote research efforts toward outcome measures and technologies for personalized medicine in cancer that will cut cost and improve survival. I will spearhead efforts to promote large multicenter trials for evidence-based, cost-effective treatments that emphasize patient safety—options that third-party payers covet. These are challenging times indeed, and our Academy, as one of the most progressive specialty societies, is uniquely positioned to lead the way for a new era in physician advocacy and leadership.

Candidate Statements: Audit Committee

What is your particular experience or interest that would make you an effective member of the Audit Committee of the Academy? It is my great pleasure to run for re-election to the Audit Committee of the AAO-HNS. The committee’s important role is to confirm that the budget is aligned with the Academy’s strategic plan. This is a critical mission that ensures greater accomplishments in the future so an Audit Committee member should have a global understanding of the Academy’s function, as well as training in the ability to evaluate financial statements. I have both of these requirements, and I also have a passion for the Academy. As an active member in committees, associate editor for the journal, CORE grant reviewer, and involved with presenting at the scientific and research programs, I believe that I have a great understanding of the value of this work. Adding to this perspective is my devotion to these and other activities outside the Academy, such as instruction courses, resident and fellow education at the Mount Sinai Medical Center, publishing, and community involvement. I am also the upcoming treasurer of the American Laryngological Association, and have a background in accounting and finance from a recent program in Managing Healthcare Delivery at Harvard Business School. I look forward to the opportunity to serve on this committee.

Candidate Statements: Secretary Treasurer

Candidate Statements: President-Elect

Sujana S. Chandrasekhar, MD These are challenging times in medicine, and especially in otolaryngology. It seems with every breath there is another arrow of uncertainty headed our way, whether it is ACOs, patient satisfaction surveys, decreasing reimbursements, education for MOC, healthcare reform rollout, ICD-10, or internal divisions between subspecialties, practice types, etc. Navigating these challenges requires experienced leadership. I have practiced successfully in two academic settings, and for the past 10 years I have had a successful solo private neurotology practice while working part-time at the VA and building a new multidisciplinary clinical program within a large hospital system. With my Academy experience as past Board of Governors (BOG) chair, at the Board of Directors (BOD), in education, advocacy, development, and with the Women in Otolaryngology (WIO), Diversity, and Young Physician Section (YPS), I have a good understanding of the needs of the entire otolaryngology community. If I become President-Elect, my three goals will be: 1. Increase member participation in all areas of the Academy It is disheartening to hear members say that they don’t see value in their membership, that they don’t need the Academy or the meetings, that they are only involved in their subspecialty, or that they think that ENT is so small that we can’t make a difference. What we’ve got here is a failure to communicate. As President-Elect, I would like to harness our website to enhance member and committee communications, to go to where the members are, and to find out who’s not participating and why. Our Member Handbook highlights educational, financial, and advocacy benefits of membership and must reach all otolaryngologists. I would continue to strengthen our working relationship with subspecialty ENT societies. We thrive by identifying and mentoring future leaders, whether they are residents or fellows or well into their careers. That is one of my passions. 2. Strengthen the Academy’s position as a leader in organized medicine Despite its relatively small size, our Academy has been a leader in organized medicine. We are strong with legislators and we collaborate with the larger house of medicine on key issues. We lead in Guideline development and at the Choosing Wisely® campaign. As President-Elect, I will work with the new EVP/CEO to strengthen our leadership position and to spearhead efforts that help our members thrive financially by making it as easy as possible to comply with upcoming regulations, including establishing ENT-pertinent quality measures. With 100 percent participation in the PAC, we can show our strength on Capitol Hill. 3. Make the Academy’s website the go-to site for ENT information Fifty percent of all doctor visits are for ENT problems. Our Academy has vetted teaching materials, but they are hard to access. As President-Elect I would work to expand mobile access to our website so that when physicians or patients search for detailed ENT information, they come to our site. This would also help our members serve their patients better while practicing more efficiently. It has been a pleasure serving the Academy for all of these years, and it would be an honor to serve as its President. J. Pablo Stolovitzky, MD My first and foremost goal as president is to empower our members to face the most significant healthcare reform we have ever confronted. Never has the Academy been more important to the future of our specialty. The paradigm shift from fee-for-service to value-based payment is on the horizon. How do we address this challenge? I Will Set a High Priority to: Develop specialty-specific quality measures and value payment models or they will be developed for us. Educate and empower otolaryngologists participating in Accountable Care Organizations (ACOs) to negotiate equitable bundled payments. Vigorously advocate for our members on healthcare reform issues affecting our specialty. My experience as a member of the Ad Hoc Payment Model Workgroup has enabled me to evaluate trends in healthcare payment reform and to develop practical methods for participating in new models. Through these contributions, the Academy will empower our members to retain equitable payment and thrive as we navigate healthcare reform. My Second Goal Is Specialty Unity. We must align strategies with our subspecialty societies to speak with a stronger voice. We should collaborate to develop quality measures and MOC materials to achieve economies of scale. My third goal, which will extend into my past-president year, is to secure sustainability. Our strategic plan prepares us for change, but requires significant revenue. Five years on the Financial and Investment Subcommittee provided me with a thorough understanding of the Academy’s budget process and its relationship to strategic initiatives, giving me excellent insight in securing sustainability. I Will Work Diligently to: Support development initiatives Increase alternative revenue streams Expand our international membership Increase opportunities for members abroad to purchase annual meeting content. My experience on the International Steering Committee and my relationship with International Leadership gives me a unique perspective to achieve this goal. As President-Elect, I Will Increase Members’ Engagement and Value by: Improving our website for mobile access to Educational activities Expanded clinical research Otolaryngology-specific EMR tools Enhancing our two-way communications with members through the newly launched ENTConnect and social media Synergizing our constituencies: Board of Governors (BOG) Specialty Society Advisory Council Women in Otolaryngology (WIO) Young Physicians, Residents, and Fellows (YP, and SRF) Now more than ever, the Academy needs a president who has the skills and experience to lead our members to adapt and succeed through challenging times. My Leadership Experience Includes: Co-founder and CEO of a thriving practice with 20 otolaryngologists Clinical faculty at Emory University, which gives me a unique perspective of both private practice and academic otolaryngology Multiple Academy leadership roles: Secretary and Chair of the Board of Governors Director on the Board of Directors Executive Committee of the Board of Directors My vision is to engage and empower our members, while enhancing our core mission of education, advocacy, and research. I am confident that my leadership experience, long term involvement in organized medicine, successful practice, and my academic and business expertise have prepared me to lead the Academy. I would be deeply honored to serve as your president.

The Opportunity to Influence the Future: Election of Leaders

As Members it is the privilege and responsibility of all to vote for future leadership. The following pages present the official statements of the candidates. Note in the box on this page the details of the voting process. Voting eligibility is outlined in the AAO-HNS/F Bylaws, and reads: Categories of Membership and Voting There shall be the following categories of membership in the Academy: Fellows, Life Fellows, Retired Fellows, International Fellows, Inactive Fellows, Honorary Fellows, Scientific Fellows, Members, Life Members, Retired Members, Inactive Members, International Members, Resident Members, International Resident Members, Associate Members, and Affiliate Members. The eleven (11) categories of membership entitled to vote on any matter shall be Fellows, Members, Fellows in Training, Members in Training, First Year Fellows, First Year Members, Scientific Fellows, Life Fellows, Life Members, Retired Fellows, and Retired Members. The phrase “voting Fellow or Member” used in these Bylaws shall mean only persons within those eleven categories of membership cited above. Each President-Elect candidate responded to three questions posed by the Nominating Committee. They are: During your term as president, what three goals would you like to accomplish that would position our Academy best for the future? What would you do as president-elect to lay the groundwork for fulfilling these goals, and what would you do as immediate past-president to promote a lasting benefit? How would you lead our Academy in adapting to healthcare reform through advocacy, quality initiatives, and member engagement? In what ways could the Academy best empower members to participate and thrive in the evolving healthcare reform landscape? How would you increase member engagement within the Academy and improve the value members receive for their annual dues? While this section begins with the candidates for President-Elect, every position open is an important position and we encourage Members to read each statement and vote for the future they envision. AAO-HNS 2014 Annual Election: Electronic Ballot All eligible voting members of the Academy, for whom we have an active email address, will receive a personal email in advance of the ballot’s “go live” date. To assure your election-specific broadcast email arrives safely in your inbox, simply add the following email address as an approved sender: noreply@directvote.net. This email will contain your confidential password to access the electronic ballot. For those eligible members for whom we do not have an email address on record, you will receive a letter in the mail with your personal confidential password. Members who wish to receive a paper ballot must submit a request in writing to ExecutiveOperations@entnet.org or call the Academy at 1-703-836-4444 and request to speak to someone in Executive Operations. The AAO-HNS election ballot goes “live” Monday, July 7, and closes at midnight Thursday, August 21.

The Coming of Age of Cell-based Therapies

From the AAO-HNS Medical Devices and Drugs Committee Committee Chair and Series Editor: Anand K. Devaiah, MD, Boston University School of Medicine and Boston Medical Center Jennifer Long, MD, PhD UCLA David Geffen School of Medicine and Greater Los Angeles VA Medical Center Otolaryngologists have a number of tools in development that may revolutionize how we practice medicine. Cell and tissue engineering is one of these exciting scientific frontiers deserving special attention by otolaryngologists. The therapeutic potential of isolated cells is a subject of intense investigation, with basic science and translational studies underway in all areas of otolaryngology. Conditions as diverse as hearing loss, vocal fold scar, the aging face, peripheral nerve injury, chronic rhinosinusitis, microtia, cleft palate, and head and neck neoplasms could benefit from cell-based therapies. Concepts for treatment include replacing injured or dysfunctional tissues, delivering a drug or therapeutic molecule directly to the site of interest, and modifying the immune or wound response to attack cancer cells or prevent adverse sequelae from injuries or surgery. We are learning more almost daily about an ever-expanding array of cell-based therapies, their behaviors in culture dishes and in animals, and new methods to generate or analyze them. With so many studies earning attention, otolaryngologists may be left wondering how to employ these emerging treatments for their patients. In reality, of the thousands of proposed ideas, far fewer are currently vetted enough for clinical trials. Thorough animal study and subsequent regulatory review is required to ensure safety and efficacy before advancing to human use, as discussed here. Cell-based therapies, defined as the introduction of cells to humans after some isolation or manipulation ex vivo, are regulated by the FDA. Like traditional pharmaceuticals, they require submission of extensive pre-clinical data in an Investigational New Drug Application, or IND, prior to any human application or clinical trial. However, the standard pre-clinical testing paradigm that has been used for decades in pharmaceutical research (centered on dose response, metabolic kinetics, and toxicities) is often inapplicable to these complex “biological therapeutics.” As such, the FDA has issued special guidance to industry, investigators, and users of cell-based technologies when preparing for clinical trials. The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Cellular, Tissue, and Gene Therapies (OCTGT), published a guidance statement in November 2013 to assist in design and implementation of pre-clinical trials of biological therapies in preparation for IND application.1 The rapid evolution of biological therapies poses challenges from a regulatory standpoint. Each IND is therefore considered in a case-by-case manner, allowing for a more individualized approach than in traditional drug and device applications. Nonetheless, the CBER has identified key objectives for pre-clinical study for new “biological products.” These include: Establishing biological plausibility, feasibility, and safety, including of the route of administration Defining patient selection criteria, starting dose and administration schedule, and outcome and monitoring parameters Identifying any public health risk to healthcare workers or patient contacts The guidelines urge investigators to address these points in animal trials submitted for IND application. Additionally, the pre-clinical study model (animal species and disease model) should be relevant to humans, and the pre-clinical product should be as similar as possible to the intended human product. CBER also issued a draft guidance statement of design considerations for early phase clinical trials, in July 2013.2 In particular, risk-benefit analysis for study participants is stressed, in light of study-related deaths and tumors that occurred in early gene and cell therapy trials. Some level of risk is inherent in studies of new therapies, especially where prior experience in humans is still limited. CBER has acknowledged the need to balance individual risk to study volunteers with potential benefits to the individual and to the greater community. This ethical issue should be considered with each new therapy and trial, including single-patient “emergency” or “compassionate use” applications that do not proceed through standard clinical trial mechanisms. Despite the scientific complexity and uncertainty about long-term risks after implantation, cell-based therapies are now being performed in humans. Trachea tissue has become an unlikely golden child in the tissue-engineering arena, thanks to multiple implantations worldwide. The first recipient of a tissue-engineered organ recently reached five years of survival with her cell-populated bronchus replacement.3 The knowledge gained from these few initial patients is invaluable for promoting the concept of cell-based therapies. Their success should support more widespread introduction of pioneering technologies into carefully planned clinical trials. References 1. Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products. November 2013. http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM376136.htm 2. Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products. July 2013. http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM359073.pdf 3. Gonfiotti A, Jaus MO, Barale D, et al. The first tissue-engineered airway transplantation: 5-year follow-up results. The Lancet 2014;383(9913):238-244. Disclosures: Dr. Long is currently an investigator in a clinical trial of a cell-based therapy. The industry sponsor, Fibrocell Technologies, supplies the processed cells. Dr. Long does not receive any compensation or research funds from the sponsor, and holds no financial interest in the company. This is another in a series of articles being produced by the Medical Devices and Drugs Committee, written by committee members, consultants, and invited guests for the AAO-HNS member. Do you have a question or topic we can address that may fall under the committee’s charge? Do you have a comment about an article? Please let us know! Email our coordinator, Harrison Peery, at hpeery@entnet.org and the chair, Anand Devaiah, MD, at anand.devaiah@bmc.org, with the subject line “MDDC question/article,” so we can properly identify and answer your query. We strive to quickly answer our “fan mail.” Please note that we will ask your permission to publish your note, in anonymous or edited form, if it becomes the inspiration for a Bulletin article.

More than Just Continuing Education Credit

The 2014 AAO-HNSF Annual Meeting & OTO EXPOSM is more than just an opportunity to earn Continuing Education credit. It’s the ideal place to find out what’s hot in otolaryngology. The conference affords you the opportunity to learn from the experts, meet interesting people, make contacts for the future, and, in general, interact with colleagues from around the world. Complementing the more than 400 hours of relevant and compelling education sessions are AAO-HNS/F membership activities, evening receptions, and forums designed to enrich your conference experience. Here’s a glimpse of some of the signature events you’ll benefit from while attending the conference. AAO-HNSF Member and First Time Attendee Orientation 5:30-6:30 pm, Saturday, September 20 This session will give you insights on how to maximize your membership with AAO-HNS by taking advantage of all member benefits and opportunities. The orientation will also focus on getting the most out the Annual Meeting to maximize your experience. Come to this session to learn about the value of the AAO-HNS, meet key leaders, and ask questions of our knowledgeable staff. Career Fair 5:30-7:30 pm, Monday, September 22 The AAO-HNS Career Fair, hosted by HEALTHeCAREERS Network. This event will take place at the Hyatt Regency Orlando. The AAO-HNS Career Fair provides opportunities for candidates in all specialties and levels of training to speak face to face with hiring representatives. Employers can leverage this opportunity to personally engage with numerous qualified job seekers at one time. Alumni Receptions 6:30-8:00 pm, Tuesday, September 23 Visit with your friends from your medical school days and colleagues from other institutions while enjoying a lavish selection of delicious appetizers and treats, and local entertainment. Check our website frequently at www.entnet.org/annual_meeting to see the latest list of alumni receptions. Board of Governors (BOG) General Assembly 5:00-7:00 pm, Monday, September 22 The BOG is the grassroots member network of the AAO-HNS and is made up of local, state, regional, and national otolaryngology societies from across the U.S. and Canada. Members of the BOG are primarily community practitioners, but all members are invited and encouraged to attend this event. CORE Research Awards Ceremony 10:30-11:50 am, Tuesday, September 23 Join us to acknowledge this year’s CORE grantees. The AAO-HNSF, specialty societies, and industry sponsors will celebrate those individuals who have developed meritorious research projects and been awarded funding through the Centralized Otolaryngology Research Efforts (CORE) grant program in 2014. Humanitarian Efforts Committee Forum 1:30-3:30 pm, Sunday, September 21 At this popular forum, the recipients of the Distinguished Award for Humanitarian Service and the Arnold P. Gold, MD Foundation for Humanism in Medicine share their overseas mission experiences. Other Academy members, residents, and fellows-in-training who recently returned from missions themselves are also invited to contribute to the discussion. This is a great networking opportunity for anyone planning a medical mission. International Assembly 3:00-5:00 pm, Tuesday, September 23 International attendees are invited to the International Assembly, a forum for recognizing guest country delegates for making awards to the International Visiting Scholars, and for leaders of International Corresponding Societies to discuss issues. Eugene N. Myers, MD, will moderate a conversation with Eben L. Rosenthal, MD, the Scientific Program Coordinator. You will also hear caucus reports from Africa, Europe, the Middle East, Latin America, and the Pacific Rim. No reservations needed! International Reception (invitation only) 8:00-10:00 pm, Tuesday, September 23 All registered international attendees and their spouses are invited to this reception where AAO-HNSF President Richard W. Waguespack, MD, will honor the delegates from our guest countries—Dominican Republic, Ecuador, Saudi Arabia, and the United Kingdom. Celebrate with a DJ, dancing, and enjoying delicious hors d’oeuvres. We encourage our international colleagues to wear their national dress or a lapel pin with their country’s flag or society emblem. Otolaryngology Historical Society Meeting 6:30 pm – 8:30 pm, Monday, September 22 Join fans of the history of our specialty at the Annual Meeting reception for an evening of papers and networking. Tickets can be purchased when you register. Poster Presentation Breakfast 7:00-8:00 am, Tuesday, September 23 Learn about the latest advancements in research directly from the sources. Ask questions and share experiences with poster presenters for a truly interactive session. President’s Reception 6:00-7:30 pm, Sunday, September 21 Held in the OTO EXPOSM, the President’s Reception is open to all Annual Meeting & OTO EXPOSM attendees, including registered guests. One of our most popular events, this reception honors the outgoing President and provide an opportunity for you to explore the Exhibit Hall. Section for Residents and Fellows-in-Training (SRF) General Assembly 2:30 pm-4:30 pm Monday, September 22 Join other medical students, residents, and fellows-in-training to discuss topics important to you at this stage in your career. The General Assembly will feature presentations from AAO-HNS leaders, a keynote speaker, section elections, an update of the annual SRF survey, and presentation of awards. As a medical student, resident, and/or fellow-in-training, this is an ideal venue to meet colleagues, have a voice, and get involved in AAO-HNS initiatives and activities. Women in Otolaryngology (WIO) Section Luncheon Noon-2:55 pm Monday, September 22 This year the WIO Section’s keynote speaker is Susan Miller, PhD, Voice and Communications Consultant, Washington, DC. Her presentation is titled, “Presenting Your Best Self.” The session is geared to encourage participants to engage in fun, interactive exercises to teach the important aspects of communication (our voice and body language) in a practical format. Women in Otolaryngology (WIO) Section General Assembly 1:00-2:00 pm Monday, September 22 The WIO Section exists to enhance the careers of women otolaryngologists. Join WIO members and supporters for presentations from AAO-HNS leaders, a keynote speaker, section elections, and presentation of awards.

Why I Give: Philanthropy Supports Education, Research, Fills Gaps

Lee D. Eisenberg, MD, MPH My connection to the Academy has spanned many years and it began immediately after my otolaryngology training at the University of California, San Francisco, in 1977. While I was a resident, our chairman, Roger L. Boles, MD, always stressed the importance of being involved. At his recommendation, I was appointed to the Committee of Terminology, the predecessor of the CPT committee, for the Academy. What I didn’t realize was, as I got closer to the inner workings of programs and resources, my philanthropic commitment would also grow. During the early years of my professional career, I gravitated to committees focusing on ensuring members had access to the body of knowledge necessary to understand the business side of medical practice. I also developed an interest in quality of care by our specialty to better serve our patients. I served on committees addressing primary care referral and patient management guidelines and was a member of the Instruction Course Advisory Committee and the Home Study Course faculty. How did these early experiences inspire my philanthropy? What impressed me as a committee and Board member was the commitment of resources that the Academy dedicates to creating, continually assessing, and delivering educational programs and products for the members to keep them informed of the advances in the practice of otolaryngology-head and neck surgery. The Home Study Course is an outstanding example of a tool appreciated and used by many Academy members that has had lasting value and adapted over time. It has a dollar value of many hundreds of dollars—and, therefore, provides great value for the membership dollar. I learned that as important as membership dues and Annual Meeting revenues are to providing operational support, these two revenue streams do not cover the costs of what is dedicated to the area of education. What covers the difference? Charitable support helps to fill the gap. The AAO-HNS is our representative in the socioeconomic arena. I have been fortunate to be involved in this area as well for many years as a BOG member, coordinator for Practice Affairs, member of the CPT Editorial Panel, Physician Payment Policy (3P) Workgroup, Surgical Quality Alliance member, and consultant to the Patient Safety Quality Improvement Committee. All of these areas require significant Academy resources, both personnel and financial. Throughout the years, I have done the math to calculate the costs entailed to ensure these meetings continue to take place. The Academy pays all the expenses incurred for sending volunteers like me and staff to be present at these critical meetings. Where would we all be if these conversations were not happening with the right people at the right time? Again, thanks to the supplemental support that comes from charitable donations, this vital effort continues. Looking at the future of the Academy, our ability to be a body of influence relies on being relevant to the physicians who are choosing our specialty. For many members, the Foundation provides research grant funding that could not be acquired elsewhere. We all understand the challenging environment that exists for obtaining such funding. We can appreciate the value of this support to those beginning their careers in the specialty. Equally important are the travel grants awarded to enable residents to connect to the Academy during the Annual Meeting and the Leadership Forum. The Board members and committee chairs of today were those who, like me, got engaged right at the start. Charitable support to these areas is an investment in our specialty and ourselves. As we know, the Academy sells its educational products, charges registration fees for the annual meeting and, of course, collects annual membership dues. These revenue sources alone are insufficient to enable us to accomplish all that is necessary to serve the needs of our members. The appreciation for all that the Academy provides, as well as the commitment of member volunteers to pursue the best for patient care in the specialty has inspired my philanthropy. Many members support the Millennium Society and are Hal Foster, MD Endowment donors. With the support of additional members, we can accomplish even more. So, please join me and the many members of the Academy who are already supporting our mission. Take a moment and visit www.entnet.org/donate. Peruse the many different ways you can support the Academy. It’s easy to support the AAO-HNS/F in a way that is meaningful to you. For questions, please contact Ron Sallerson, senior director of development, at rsallerson@entnet.org or 703-535-3775. Thank you in advance for your support.

Proposed 2014-2015 (FY15) Combined Budget

By Gavin Setzen, MD Secretary-Treasurer Budgeting for FY15 represents the collaborative work of both the staff leadership and the members of the Finance and Investment Subcommittee (FISC) to develop a proposed combined AAO-HNS/F budget for the next fiscal year, July 1, 2014, through June 30, 2015. The debt covenant requirement for a balanced budget continues to be a challenge; however, the AAO-HNS/F continues to work to support its members in the most effective and efficient way possible. The budget presented reflects the continuing effort to streamline processes and focus resources to support the strategic plan for the upcoming year. While strategic planning is an ongoing process, this year reflects a significant change from prior years. The official Strategic Plan is now aligned with AAO-HNS/F’s fiscal year and in sync with the annual budget planning. As a result, the FY15 budget takes into account the strategic priorities identified by the Boards of Directors (BODs), including critical new activities and a challenge to implement new net revenue producing activities, reduce operating expenses, and restructure/eliminate low impact programs in order to free up resources to concentrate on high-impact and new program areas. In early spring, the FISC reviewed financial results for the first six months of the FY14 budget year and we were pleased to see that AAO-HNS/F was projecting a favorable variance, as compared to budget, for the year. The 2013 Annual Meeting & OTO EXPOSM once again netted favorable results and staff continues to identify cost savings. This was all done under the leadership of David R. Nielsen, MD. The budget planning process involved each of the business units of AAO-HNS/F submitting their budget to the financial team that worked with them to assure that the revenue and expenses were in line with the mission and priorities of AAO-HNS/F. The financial team is composed of Brenda S. Hargett, chief operating and financial officer (COO); Lynn Frischkorn, director of Budgeting and Special Projects; and Carrie Hanlon, senior director of Financial Operations. The financial team presented the proposed budget to the FISC for an initial review in early March and then a final proposed budget in late March. Once reviewed and approved by FISC, the proposed FY15 budget was presented to the Executive Committees (ECs) of the BODs recommending their endorsement for approval by the BODs. The ECs endorsed the FY15 proposed budget during their April meeting. Also in April, the BODs reviewed and conditionally approved the FY15 budget that is presented here for our membership.

Residents and Fellows-in-Training 2014 AAO-HNS Leadership Forum Update

Kanwar S. Kelley, MD, JD Chair, Section for Residents and Fellow in Training Resident, U.C. Irvine In early March, residents and fellows-in-training from around the country had the opportunity to attend the Academy Leadership Forum in Alexandria, VA. In spite of a winter storm, snarled travel plans, and the annual in-service exam the day before the forum—a record number of residents and fellows (29) were able to attend thanks to the incredible generosity of the Academy and donors who supported Resident Leadership Grants. A total of 103 members were present. As part of the BOG and Academy’s dedication to outreach for residents and young physicians, content was tailored to the specific needs of our group. Panels on practice management, hospital and employee contract negotiation, legislative and political advocacy, and health policy all ensured an enriching experience. The forum guest speaker Rep. Andy Harris, MD, (B.-MD) of the U.S. House of Representatives highlighted the presentations, and networking events between residents and Academy leaders were dedicated to the training and development of young physicians. One of the Section for Residents and Fellows-in-Training’s (SRF) top priorities this year has been to increase resident and fellow involvement in advocacy related efforts. In coordination with the ENT PAC the AAO-HNS political action committee, the SRF campaign has had a great start. It was my absolute pleasure to announce at the forum that U.C. Irvine was able to achieve 100 percent resident participation in 2013. Other programs made great progress as well. With an election year in full swing, every resident and fellow is encouraged to become a donor to ENT PAC no matter how small the dollar amount. The Leadership Forum provided incredible insight about health policy, advocacy efforts, and leadership development. We recommend every resident or fellow take part in during the course of their training. I hope to see everyone in Orlando, Monday, September 22, during the SRF General Assembly and in Alexandria next March. If you know a resident or fellow doing exceptional work inside or outside of his/her program, nominate her/him now for our quarterly resident and fellow spotlight. Email your nomination to SRF@entnet.org and we will contact you. *Contributions to ENT PAC are not deductible as charitable contributions for federal income tax purposes. Contributions are voluntary, and all members of the American Academy of Otolaryngology-Head and Neck Surgery have the right to refuse to contribute without reprisal. Federal law prohibits ENT PAC from accepting contributions from foreign nationals. By law, if your contributions are made using a personal check or credit card, ENT PAC may use your contribution only to support candidates in federal elections. All corporate contributions to ENT PAC will be used for educational and administrative fees of ENT PAC, and other activities permissible under federal law. Federal law requires ENT PAC to use its best efforts to collect and report the name, mailing address, occupation, and the name of the employer of individuals whose contributions exceed $200 in a calendar year. 2014 AAO-HNS Leadership Forum a Great Success! Otolaryngologists from around the country convened in Alexandria, VA, March 2-3, to participate in a successful inaugural AAO-HNS Leadership Forum. Despite a city-stalling snowstorm, a warm and exciting exchange of information and friendships took place. The clear message: our voice is heard amongst the AAO-HNS leadership. The Board of Governors (BOG) is an integral participant in the Academy’s Executive Committee, with our chair a voting member, and our chair-elect a standing guest. Along with the immediate past chair of the BOG both are voting members of the Board of Directors (BOD). In addition, the BOG has formal representation to the 3P (Physician Payment Policy) Workgroup. All of these venues allow the BOG to communicate important information to and from you, the membership, and the Academy. The focus of this year’s Leadership Forum was on Advocacy, Research and Quality, Education and Knowledge, Sustainability, and Membership Strength and Unity. See the whole story online at www.entnet.org when you Login as a Member.

Denis C. Lafreniere, MD, BOG, Immediate Past Chair

ICD-10 Delay: Was It Worth the Wait

The 2014 AAO-HNS Leadership Forum which took place March 2-3 in Alexandria, VA, was a rousing success bringing AAO-HNS, BOD, and BOG members (including a significant number of otolaryngology residents) together to discuss a wide variety of topics including the transitioning to ICD-10 coding. Robert R. Lorenz, MD, gave an informative talk on where our practices should be in the ICD-10 transition process as we approached the scheduled October 1, 2014 deadline. Shortly after that meeting the U.S. House of Representatives changed that schedule when it quickly passed by voice vote bill HR 4302, “Protecting Access to Medicare Act 2014.” This bill, which was also passed by the Senate and signed by the President, delayed the onset of the ICD-10 changes by a minimum of one year, now starting no earlier than October 1, 2015. On its face this legislation could have appeared to be a win for many of our independent practice colleagues who may not have been on schedule for the October 1, 2014 deadline. However, this postponement of the ICD-10 implementation could also be viewed as a wolf in sheep’s clothing due to the Sustainable Growth Rate (SGR) patch that was once again used to delay a permanent fix to this broken system of adjusting Medicare payments. The AAO-HNS has been committed to supporting legislation to repeal the SGR for the last several years. They have worked to educate Congress regarding the instability of the Medicare payment system. They have repeatedly outlined to Congress that this instability in the Medicare payment system is threatening our patients’ access to healthcare by making it difficult for our members to make plans for the future of their practices, to invest in their practices, to provide for their employees and to make investments to help improve the quality and efficiency of the care they provide. The quick passage of yet another SGR patch ignores significant cooperative efforts and sacrifices offered by the House of Medicine over the past year to permanently fix the SGR. The cost of fixing the SGR had never been as affordable as it was this past year yet all these efforts were brushed aside and the SGR can was once again kicked down the road. The short-term gain of an ICD-10 delay seems to have sugar-coated this otherwise bitter political pill. Delay in the implementation of the ICD-10 system has in its own right caused some concerns for many institutions who were “on track” for the October 1, 2014 implementation date. Many institutions have spent millions of dollars and significant time and effort in preparing for the implementation. The delay in the timeline so close to the start date means that the delay occurs just as the testing of the modified systems was set to begin. Testing typically occurs in the last six months checking how the system will work with third party payers. There are significant resources put into the education of the providers and staff as well. Many organizations have contracts with outside consultants hired to educate the providers. These contracts may need to be amended or extended to avoid a large gap between the time of education and the time of implementation of the new paradigms. Some institutions may have to maintain both the ICD-9 and ICD-10 systems in parallel until the change is made permanently. This can significantly alter an institution’s project management perspectives. Another issue is that the change in implementation date is not yet fixed as the legislation reads “not before” Octobert 1, 2015 which means this could be delayed yet again. Since the decision was taken out of the hands of CMS (which had vowed not to delay ICD-10 implementation ever again) we are left with Congress once again holding hostage our ability to plan for the future of our practices. The brave new world of healthcare reform continues to show us an ever-changing and therefore unpredictable landscape. We must continually educate our colleagues and our representatives as to the ultimate impact of many of the decisions made in our state houses and in Washington. We should never lose sight of the forest for the trees! References AAO-HNS Overview: Federal Legislative Priorities. Government Affairs, www.entnet.org/advocacy. Carr, David. ICD-10 Delay Creates Headaches. Information Week Healthcare 4/3/14.

Your Legacy of Leadership: What Are You Optimistic About?

As time passes, I become more used to the ebb and flow of Academy timelines. June marks the end of the school year and the beginning of summer for our youth. It also means the introduction of our candidates for Academy leadership positions, and reminds me of the incredible legacy each Academy member leaves as he or she participates in strengthening our specialty. Please take time to get to know the candidates for Academy offices and carefully review their statements, backgrounds of service, and their perspectives on the future of the specialty. Each year, the Nominating Committee does a remarkable job of poring over dozens of names, evaluating their merits in light of the strategic direction of the AAO-HNS/F, and matching the best people they can with critical positions of leadership. I express my heartfelt thanks to James L. Netterville, MD, Nominating Committee Chair, and these thoughtful and hardworking Academy volunteers who take this assignment seriously and put in a tremendous amount of work to ensure our leaders are chosen from truly outstanding candidates. I also want to offer my thanks to those who were so highly respected that their names were solicited and who agreed to be considered, but may not have been nominated at this time. Out of thousands of Academy members, it is a great honor from your colleagues to be asked if you would allow your name to be considered for nomination. I am certain, and history bears this out, that those who were considered, but not nominated this year, will have future leadership opportunities. Author and leadership consultant Holly Duckworth of Leadership Consultants International recently presented a stimulating session at the 2014 Great Ideas Conference of the American Society of Association Executives (ASAE) on inspiring action in associations and their leaders. Using the model of “rebooting” our computers to upgrade or improve function, she advises that we “control/alt/delete,” or reboot, in our leadership lives, too. Leaders often face the challenges, doubts, and fears of constrained resources matched against unlimited demands. Successful leaders learn to control their doubts and fears; alternatively replacing them with courage, faith, and abundance. Deleting the inertia, sacred cows, irrelevant programs, special interest resource sinks, and outdated policies of the past is essential before we can replace them with the changes that will increase our relevance, value, and meaning to our members. As leaders, we have to ask ourselves, to what degree are we taking control of, or owning our responsibility to influence, our attitudes and biases and those for whom we have stewardship? Do we bring to the table an attitude of abundance or of scarcity? Do we recognize every challenge as an opportunity, or just a barrier to getting what we want? (To see the slides from Ms. Duckworth’s presentation, visit http://www.slideshare.net/hollyduckworth/140121-isae-ctrlaltbelieve.) In suggesting solutions, she counsels us to replace the word “delete” with “believe.” Look for her book, Control, Alt, Believe, in the fall. In December 1996, author John Brockman began an online community with about 50 people known as “Edge—The World Question Center.” Its purpose? To arrive at the edge of the world’s knowledge, seek out the most complex and sophisticated minds, put them in a room together, and have them ask each other the questions they are asking themselves. It’s now grown to millions of individual users. For its 10-year anniversary, the 2007 Edge Annual Question was “What are you optimistic about?” What a great question! How would you respond? I’m optimistic about the future of our specialty. I’m optimistic about advancing technology and improving the lives and health of our patients. I’m optimistic about our residents and the next generation of otolaryngologists. I’m optimistic about our future leaders—and the slate of candidates for office. I’m optimistic about the professional skill, creativity, and problem solving ability of our wonderful staff. I’m incredibly optimistic about the loyalty, volunteerism, and contributions of our membership. Few associations have members who truly “own” their organization the way we do. As members, we own by engagement and participation, not just simply by fiscal standards. This summer, I hope every Academy member will take time to evaluate the leaders who will provide direction and guidance for the coming years. Vote, engage, share your perspective. Let our leaders know what you expect and how you are willing to work with them to achieve the vision of a brighter future as we work together to empower doctors to provide the best ear, nose, and throat care.

Supporting Leadership When Your Appointment Book Is Already Full

This issue premiers the official statements of the candidates for Leadership 2014. Having had this same task as a potential candidate, I remember the thought and preparation required. It is not an easy assignment even when one has been deeply involved in the complexity of the socioeconomic needs of our specialty over many years. The opportunity to lead is exciting and daunting in equal shares. Like many of you, I had opinions about our organizations’ greatest strengths, weaknesses, opportunities, and vulnerabilities. I further researched the available data and concluded that our strategic planning process and the caliber of Academy/Foundation leadership were our greatest strengths. I saw, too, the immensity of the one challenge that gave me the most concern, “the relentless trend of decreasing reimbursement and increasing expenses and administrative burdens.” And as I saw the looming reach of the Affordable Care Act, I was troubled by the “additional mandates to employ EMRs, utilize electronic prescribing, and implement ICD-10 diagnostic coding.” I said then that I believed it was the Academy’s role to provide members with as many tools as possible to deal with these coming changes and to mitigate negative impacts when possible. See more at: http://bulletin.entnet.org/article/official-statements-of-leadership-candidates-3/. Indeed, this has been the challenge that we continue to address as you can see in almost every Bulletin and weekly e-mail of AAO-HNS The News. But, what really has been my professional experience of leadership, and what can I share with you about how you as a Member can influence your leaders when your appointment book is full? Influencing Your Leaders for Better Outcomes While the step-by-step role of leadership in working on such challenges initially looked definable to me, I have been somewhat surprised by what has turned out to be the biggest responsibility and benefit of leadership. Let me rely here on an expert to explain. Jim Yong Kim, MD, current leader of the World Bank, spoke recently with Lillian Cunningham, of The Washington Post, about facing challenges on the occasion of its first reorganization in 20 years and his accompanying pledge to save $400 million in administrative costs. Dr. Kim simply expressed this opportunity: “One of the most important things about leadership is that you have to have the kind of humility that will allow you to be coached. . . . No matter how good you think you are as a leader, my goodness, the people around you will have all kinds of ideas for how you can get better. So for me, the most fundamental thing about leadership is to have the humility to continue to get feedback and to try to get better — because your job is to try to help everybody else get better.” (http://www.washingtonpost.com/blogs/on-leadership/wp/2014/04/10/trying-to-change-the-world-bank) So, I know well that your patients and your practices are your first priority as they should be and that you are often pulled in myriad directions for what small time you can reserve for other responsibilities and interests. My message here is that you can give more than you know when you communicate with your leaders about how they are addressing your needs, your concerns, your solutions, your challenges. This is the time of year when you can influence the AAO-HNS/F most—with your vote. Ensuring the future My partner, our colleague, our AAO-HNS/F trusted representative for 12 years, David R. Nielsen, MD, will conclude his tenure as Executive Vice President and CEO in January 2015. David has acted often as my coach in big and small ways over my term as your President. I have had total confidence in his ability to stand in for the voice of the specialty within the greater world of medicine, and regulatory bodies. While epitomizing the humility that Dr. Kim sees in great leadership, Dr. Nielsen has maintained that necessary passion for open direct dialog with members and others that forwards both his and the specialty’s growth and change–the most nourishing elements for a sustainable future. With your continuing feedback to leaders like Dr. Nielsen, take this moment to further ensure our continued organizational success following David’s actions. Give back to the specialty though the David R. Nielsen, MD Endowment. This gift directly influences our future as the funds will be applied where needed most. Don’t let this opportunity go to extend your influence today, more at www.entnet.org/donate.