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ACOS Newsletter, Year-End 2012 Dear ACOS Members, The most recent ACOS Summit held in Chicago in November fully lived up to ACOSs mission of educating its members on the clinical, business, and medicolegal aspects of ophthalmology. Taking place on the heels of the 2012 presidential election, we had a very timely post-election analysis from a noted Washington lobbyist, which is our feature article in this newsletter. Other medicolegal presentations included new regulatory rules on consulting, off-label promotions, and cash-pay procedures. On the business side, we learned about the economics of the current FDA approval process (also summarized here), and we received an update on corporate surgery centers. The summits clinical presentations ran the gamut from a point/ counterpoint on simultaneous LASIK and cross-linking, to the latest on laser cataract surgery, to a review of MIGS devices to manage glaucoma. As always, this ACOS program was impressively on-point, and I hope youll enjoy the following samplings. Let them get you excited for the ACOS-Dulaney Winter Meeting, held at the beautiful St. Regis in Aspen. This popular meeting fills up quickly every year, so register soon! Best, Stephen G. Slade, MD ACOS President

Election Outcomes
By Jeffrey J. Kimbell, President of Jeffrey J. Kimbell & Associates, Washington, DC President Obama handily won reelection over Governor Mitt Romney, backing up a decisive win in 2008 with a second decisive victory in the Electoral College with 332 Electoral College votes. Obama did this through unprecedented campaign organization efforts, with a ground game that was able to beat back Republicans' enthusiasm edge. In doing so, President Obama became the first president since James Madison in 1812 to win with a lower percentage of the vote in his second-term victory than
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in his first. Many Americans wondered how the advent of SuperPACs would change politics. Throughout the long election cycle, both Presidential campaigns spent over $1 billion, but Obama got a much larger return on his investment. Romney was only able to win two more states (Indiana and North Carolina) than John McCain won in 2008, despite the more suitable political environment for Republicans in this election as compared to 2008. Election Outcomes In the Senate, Democrats were able to expand their majority, netting two more seats with close victories in several states across the country. Democrats were able to hold onto all but one of their seats, many of which were close races that political experts in Washington believed Republicans could win, while winning races for Republican seats in Indiana and Massachusetts. Republicans picked up the Democratic seat in Nebraska with Deb Fischers (R-NE) win over Bob Kerrey (D-NE), but this was offset by Angus Kings (I-ME) victory in Maine, as King will caucus with the Democrats. In the end, the Democratic caucus in the Senate will expand to 55 seats in the next Congress.

Figure 1

In the House, Republicans were able to maintain their majority (Figure 1), largely due to efforts during the redistricting process to shore up vulnerable seats that were picked up during the 2010 midterm election cycle, which was a wave election for House Republicans. Though losing a net of eight seats, this allowed Republicans to hold onto 234 members out of 435, giving current Speaker of the House John Boehner (R-OH) the second largest Republican House majority in the history of the party. Unfortunately for the eye care community, Congresswoman Nan Hayworth (R-NY), an ophthalmologist, lost her reelection bid and will not return to Congress in 2013. Lastly, despite losses at the Presidential and Senate levels, Republicans were able to pick up one Governors mansion in North Carolina. This gives Republicans control of 30 Governors' mansions, which is critical, as future implementation of the Affordable Care Act (ACA) will largely shift to the states.
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At the end of the day, this election gave us the status quo, as neither party was able to take majority control of any chamber or office of which they did not already have the majority. However, there has been a large amount of turnover in Congress through the past several election cycles. There will be 95 freshman members of Congress in 2013, 83 in the House and 12 in the Senate. After the last Congress added a freshman class of 113, this means over one-third of the 535 elected federal representatives of this country in the House and Senate will have 2 years of experience or less. While this lack of experience seems daunting at first glance, it can be prove to be an opportunity. These new members need input from proponents of the life-science community to educate them in order to craft more judicious legislation. That is why I push for medical technology companies to send their senior executives and managers to Washington. Members of Congress need to know the goals and challenges facing the life-science industry, from the laboratory bench, to manufacturing, to distribution, and everywhere in between. Likewise, members of Congress need to understand what clinicians do on a daily basis, and thus your input is essential. Currently, only 7% of physicians are members of the American Medical Association (AMA), down from 40% to 50% a generation ago, and members of Congress do not realize that the AMA is much less representative of todays practitioners than it used to be. Demographics of the Presidential Election Exit polls from this election lent credence to demographic trends, which I believe do not bode well for today's Republican Party. Obama was able to fortify his key demographics from 2008: Hispanics supported him with 71% of their vote (67% in 2008), African Americans with 93% of their vote (95% in 2008), and people under 30, whom he carried with 60% of the vote (66% in 2008). Obama also maintained the gender preference for Democrats, garnering 55% of the female vote compared to 56% in 2008 (Figure 2).

Figure 2

I believe this shows the Republican Party can no longer hope to win elections by appealing to white voters alone, as Romney won 59% of the Caucasian vote in a losing effort. Furthermore, every year, the US population becomes 2% more diverse, exacerbating the Grand Old Party's demographic
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problems in the years to come. Republicans will have to do some soul-searching to find new ideas and candidates that will make the party more appealing to women and minorities in order to compete nationally in future elections. The Real Reason Romney Lost During the primary, we saw Republicans break Ronald Reagans 11th commandment of never speaking ill of someone in their own partywith regularity, I might add. By the time Romney secured the Republican nomination, his campaign was already broke from having to run ads to fend off over $100 million in negative messaging from his primary opponents. Furthermore, Federal Election Commission (FEC) laws prohibited Romney from using general election dollars to run ads until September 1st, meaning he was unable to run a single campaign ad between April 11th, when he unofficially secured the nomination, and September 1st. This placed him in a bind that the Obama campaign capitalized on, running scores of negative ads for weeks about Romneys record at Bain Capital in order to paint him as a man who was out of touch with middle-class Americans. In the end, it workedRomneys unfavorable ratings reached over 50% by September, and he never really recovered. The two campaigns also approached spending very differently. Republicans generally rely on wealthy individual donors to fund TV advertisements and other messaging materials. However, the Democrats have worked since the 2008 primaries to build a national infrastructure for Obama by setting up multiple campaign offices with staff in every state. This network is what fuels the Obama campaigns prestigious ground game. Realizing the discrepancy on the ground, Romney attempted to counter Obamas infrastructure edge in essentially 90 days with no campaign fundsa task that proved impossible. What Happens Next? The 112th Congress began its lame-duck session Tuesday, November 13th. Between that time and the holiday recess, party leaders have been assigning the new members of the House and Senate to various committees and subcommittees. The next 6 months will be the most critical time to educate your legislators about the needs of the eye care profession, especially since the ophthalmic community lost a champion in Congresswoman Hayworth. During this time, I also suggest you contact your State Governors and Insurance Commissioners to register your concerns, because these individuals will become more important to the practice of medicine than anybody else in the country in the years ahead. Once the new Congress begins in January, I believe lawmakers will begin a heated discussion about a major tax overhaul, rewriting the tax code for businesses, individuals, trade, etc. Second terms are about legacy, and I will remind you that some very good policies came out of President Clintons second term. Obamas team knows it has to address taxes as part of the countrys major fiscal challenges, and legacy will be a factor in Obamas positioning. Furthermore, I believe that in order for America to be competitive in the future, the parties will have to find some common ground. We may yet see the bickering in Washington put on hold to tackle the pressing issues of todays America. Lets hope so. Jeffrey Kimbell is the President of Jeffrey J. Kimbell & Associates, a lobbying firm based in Washington, DC. His firms expertise is in helping life-science companies navigate and influence federal policy. He provided ACOS attendees with an analysis of this years election cycle and may be reached at (202) 534-1771; jkimbell@kimbell-associates.com.

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FemtoPhaco Early Adoption: How I Made it Work for Me

By Vance Thompson, MD, Sioux Falls, South Dakota Dr. Thompson refers to this technology as Refractive Laser-Assisted Cataract Surgery (ReLACS) and includes within this service offering a premium IOL, laser-assisted cataract surgery, intraoperative aberrometry, and a refractive enhancement, if necessary. He uses the LenSx device (Alcon Laboratories, Inc.) and has treated approximately 1,600 cases thus far. He likes the reproducible accuracy of the technology and considers it a value proposition for his patients. Dr. Thompson feels that patients decision to choose the elective option comes down to their answer of this question: Do you want to wear glasses frequently or infrequently? He says that practitioners must understand the business value of this technology; that it offers both refractive and therapeutic benefits to patients. To justify the refractive offering, Dr. Thompson has given a dollar value to each pre-, intra-, and postoperative procedure involved in ReLACS, based on how often he and his staff use each one, to determine a total price for the elective option (Figure 3). He also stresses that surgeons must adopt the refractive mindset with these patients and make sure they are happy with their vision after surgery. Superior outcomes are the key to widespread adoption, he believes.

Figure 3

Vance Thompson, MD, is the founder of Vance Thompson Vision in Sioux Falls, South Dakota. He is a researcher for and a consultant to Abbott Medical Optics Inc.; Alcon Laboratories Inc.; and Bausch + Lomb. Dr. Thompson may be reached at (605) 3283937; vance.thompson@sanfordhealth.org.

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FemtoPhaco Early Adoption: What I Need to Know Before I Commit

By Douglas D. Koch, MD, Houston, TX
Dr. Koch believes there are eight important logistical questions surgeons need to answer before choosing a femto cataract technology. 1. How do I pay for it? - costs (Figure 4) - collections 2. How does it fit in my practice? - patient demographics - community demographics (potential to expand volume) - do other practices in the community have the technology, and if so, will it offer me a competitive advantage or is it primarily a defensive move? 3. Where do I put it? - available space - number and timing of surgeons using it - lasers environmental requirements - need to factor in build-out costs 4. How do I staff it? - train existing personnel, or hire new technician? 5. How do I schedule OR time? - sequence of cases - integrating multiple surgeons 6. How do I market it? - internet, radio, TV, print? 7. How do I schedule clinical visits for these patients? - how to provide premium service - should I change how I provide telephone access to patients? - should I change my clinics scheduling to minimize wait time? 8. How do I educate my patients about this technology? - hire or train a patient counselor? - literature or videos, internet, apps?

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Figure 4

Dr. Koch concluded by citing multiple resources of information to help answer these questions: AAO, ASCRS, industry magazines, manufacturers, consultants, and colleagues. Douglas D. Koch, MD, is a professor and the Allen, Mosbacher, and Law chair in ophthalmology at the Cullen Eye Institute of the Baylor College of Medicine in Houston. Dr. Koch may be reached at (713) 798-6443; dkoch@bcm.tmc.edu.

Femtophaco Complications
By Michael A. Lawless, MBBS, FRANZCO, FRACS, New South Wales, Australia
Dr. Lawless and his group of six surgeons started performing femtosecond cataract surgery in February 2011. The group has since performed 2,650 cases, and he has personally performed 610 surgeries. Dr. Lawless and his colleagues published a paper in May in Ophthalmology on their first 200 eyes,1 and a follow-up article on the next 1,300 eyes (same surgeons) has been accepted for publication in Ophthalmology early next year.

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Figure 5

The first series showed a learning curve with a fairly high rate of complications in the first 200 eyes (Figure 5). The main vision-threatening complications were anterior radial tears, anterior capsular tags, and posterior lens dislocations. The rates improved with the larger series. In his first personal 500 eyes, Dr. Lawless experienced a few minor complications such as suction loss, but for serious complications, he only had one anterior radial tear, zero posterior capsular tears, and zero lens dislocations. He then compared these rates to other figures published in the literature (Figure 6).

Figure 6

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Because several of these studies had large patient numbers and therefore reflected real-world experience, Dr. Lawless said that he felt confident telling the ACOS audience that, in his opinion, laser cataract surgery is statistically significantly safer to perform than manual surgery. He then gave three tips for avoiding complications with laser cataract surgery: 1. Proper docking. Dr. Lawless said that docking is the key to a successful surgery. This includes patient fixation to center the treatment; making use of Bells phenomenon; and redocking if the first attempt is not ideal. 2. The capsulorhexis. Dr. Lawless noted that the majority of capsulorhexes are free-formed, although sometimes surgeons may get small tags. His standard size is 5 mm in diameter. He cautioned not to assume that the capsulorhexis is perfect until the tissue is removed. 3. Hydrodissection. Although Dr. Lawless does not routinely perform hydrodissection, when he does, he is careful to decompress the anterior chamber to release any retrolenticular gas. He recommends performing this step in a slow, steady, titrateable manner. 1. Bali SJ, Hodge C, Lawless M, et al. Early experience with the femtosecond laser for cataract surgery. Ophthalmology. 2012;119(5):891-899.

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