December 19, 2018 | | JFAS | Contact Us

News From ACFAS

New Board Members Elected
Congratulations to the newly elected ACFAS board members from online balloting that ended on December 17:
  • Brian B. Carpenter, DPM, FACFAS
  • Michael J. Cornelison, DPM, FACFAS (Incumbent)
Drs. Carpenter and Cornelison will serve three-year terms (2019–2022).

Also serving on the 2019–2020 Board of Directors are Christopher L. Reeves, DPM, MS, FACFAS, President; Scott C. Nelson, DPM, FACFAS, President-Elect; Thanh Dinh, DPM, FACFAS, Secretary-Treasurer; John S. Steinberg, DPM, FACFAS, Immediate Past President; Eric A. Barp, DPM, FACFAS; Meagan M. Jennings, DPM, FACFAS; George T. Liu, DPM, FACFAS; Harry P. Schneider, DPM, FACFAS; and Randal L. Wraalstad, DPM, FACFAS.

The new board will be installed on February 15 during the ACFAS 2019 Scientific Conference in New Orleans.
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Avoid a Late Fee: Pay Your Membership Dues by 12/31
December 31 is the final day you can pay your ACFAS membership dues and avoid a late fee! Renew your membership now at or via mail or fax to continue your member benefits.

All Fellow and Associate Members should have received their 2019 ACFAS dues reminders by mail and email. If you have questions or need another statement, contact the Membership Department at (773) 693-9300.
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Defrost Your Practice Marketing Efforts with Winter FootNotes
Why put your practice marketing efforts on ice until after the new year when Winter FootNotes is here to help? Download this latest issue from the ACFAS Marketing Toolbox and post it on your website, share it through your social media channels and distribute copies to your patients.

Articles in this issue include:
  • Don’t Invite Gout to Your Holiday Feasts
  • Ice-Related Falls Can Wreak Havoc on Ankles
  • Keep Your Feet Safe at the Gym in the New Year
Add your practice contact information to the editable space on page 2 of FootNotes so new and existing patients can easily reach you.

Visit for many other free resources, including infographics, PowerPoint presentations and healthcare provider referral tools, to boost your outreach to patients and your community throughout the year.

New products are added to the Toolbox regularly—watch ACFAS publications and social media for updates on new releases.
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Foot and Ankle Surgery

Midterm Outcomes of a Synthetic Cartilage Implant for the First Metatarsophalangeal Joint in Advanced Hallux Rigidus
A study was conducted to evaluate safety and effectiveness outcomes for synthetic cartilage implant hemiarthroplasty to treat hallux rigidus at a minimum of five years. A total of 112 eligible patients were enrolled, with pain visual analog scale (VAS), Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) and FAAM Sports subscales completed preoperatively and two and five years after the procedure. Also assessed were great toe active dorsiflexion, weightbearing radiographs, secondary procedures and safety parameters.

At two years, 9.2 percent of patients had undergone implant removal and conversion to arthrodesis. In years two through five, 7.6 percent of patients underwent implant removal and conversion to arthrodesis. At an average of about six years' follow-up, pain VAS, FAAM ADL and FAAM Sports scores improved by 57.9 plus or minus 18.6 points, 33.0 plus or minus 17.6 points and 47.9 plus or minus 27.1 points, respectively, from baseline. Clinically significant changes in VAS pain, FAAM ADL and FAAM Sports were reported by 97.2 percent, 90.5 percent and 93.3 percent of patients, respectively. Patient-reported outcomes at two years were maintained at 5.8 years in patients who were not revised. Active metatarsophalangeal joint peak dorsiflexion was maintained, and 99 of 106 patients would repeat the procedure.

From the article of the same title
Foot & Ankle International (12/03/2018) Glazebrook, Mark; Blundell, Chris M.; O'Dowd, Dominic; et al.
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Reliability, Surgeon Preferences and Eye-Tracking Assessment of the Stress Examination of the Tarsometatarsal (Lisfranc) Joint Complex
The primary objective of this study was to determine the level of agreement and reliability of the stress examination of the Lisfranc tarsometatarsal joint complex. Secondary objectives were to determine surgeon preferences with respect to this testing and to use gaze recognition software to perform an eye-tracking assessment during the performance of the test.

Twelve foot and ankle surgeons, 12 residents and 12 students were shown two intraoperative fluoroscopic still images and one video of the stress examination of the tarsometatarsal joint complex using stress abduction of the forefoot on the rearfoot. Participants were asked to evaluate the result as being "positive" or "negative" for tarsometatarsal joint stability. The overall reliability of the interpretation of the stress examination was a kappa of 0.281 (surgeons 0.182, residents 0.423 and students 0.256) indicating "fair" agreement. Survey results indicated wide variability in the perioperative preferences and protocols of surgeons dealing with the evaluation and treatment of the tarsometatarsal joint. Eye-tracking results also demonstrated variability in the anatomic structures of interest focused on during performance of this testing.

The results of this investigation provide evidence of reliability well below what would be expected of a gold standard test during stress examination of the Lisfranc tarsometatarsal joint complex. These results indicate that future scientific endeavors are required to standardize the performance and interpretation of this testing.

From the article of the same title
Journal of Foot & Ankle Surgery (11/15/18) Naguib, Sara; Meyr, Andrew J.
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Resurgence of Diabetes-Related Nontraumatic Lower-Extremity Amputation in the Young and Middle-Aged Adult U.S. Population
The goal of this study was to determine whether declining trends in lower-extremity amputations have continued into the current decade. Researchers calculated hospitalization rates for nontraumatic lower-extremity amputation (NLEA) for the years 2000–2015 using nationally representative, serial cross-sectional data from the Nationwide Inpatient Sample on NLEA procedures and from the National Health Interview Survey for estimates of the populations with and without diabetes.

Age-adjusted NLEA rates per 1,000 adults living with diabetes decreased by 43 percent between 2000 and 2009 and then rebounded by 50 percent between 2009 and 2015. Meanwhile, age-adjusted NLEA rates per 1,000 adults without diabetes decreased by 22 percent in that time period. The increase in diabetes-related NLEA rates between 2009 and 2015 was driven by a 62 percent increase in the rate of minor amputations and a smaller, but also statistically significant, 29 percent increase in major NLEAs. The increases in rates of total, major and minor amputations were most pronounced in young and middle-aged adults and more pronounced in men than in women.

The researchers concluded that after a two-decade decline in lower-extremity amputations, the United States may now be experiencing a reversal in the progress, particularly in young and middle-aged adults.

From the article of the same title
Diabetes Care (11/18) Geiss, Linda S.; Li, Yanfeng; Hora, Israel; et al.
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Practice Management

New Era of Surgery Promises Safer and Tailored Treatments but Will Require New Methods of Learning, Says Report
Both surgery and surgery training are about to undergo a major transformation due to new technologies and better understanding of human biology, predicts an independent review by a commission established by the Royal College of Surgeons. The Future of Surgery report says these innovations will mean safer, less invasive and more personalized treatment for patients, as well as more predictable outcomes and faster recovery. Surgical training must adapt to allow surgeons to evaluate and embrace change, the report said, including distant and virtual learning.

The role of some surgeons is likely to become increasingly wide ranging and collaborative. Surgeons will need to understand the language of genetics, surgery, radiotherapy and bioengineering, said the report, and in the future, they may be the first healthcare professionals to discuss genetic analysis with patients. The report says more diseases could be diagnosed by blood samples instead of invasive biopsies, that "well" patients will undergo earlier, and in some cases, preventive operations and that many patients may no longer need certain cancer operations because of advances in genomics, vaccination and nonsurgical treatments.

Richard Kerr, who chaired the commission, described the forthcoming changes as "a watershed moment" that will affect every type of surgery. He said new surgical robots that are smaller and lighter, such as those coming to the market in 2019, will benefit millions of patients by making surgery faster, quicker to recover from and more accurate and successful, with less scarring. This is likely to make robot-assisted surgery more widely available in local hospitals and will narrow the gap in performance between surgeons, the report predicted.

From the article of the same title
BMJ (12/07/18) McLachlan, Greta
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Smart Ways to Respond to—and Reverse—Declining Profitability
Physician practices can address a slippage in profits by avoiding quick fixes and instead concentrating on devoting enough time to make sure they have accurately identified root causes. The first step is a thorough review of financial statements and accounting data for the past few years. Practices should compare each revenue source and expense line in detail, ensuring they have all the information needed for comparison. They then need to consider the impact of extraordinary items, delays and run rates, making sure to review both year-over-year and month-by-month financial data. One-time expenses or revenues should be filtered out to determine underlying, standardized financial performance. An overall review of accounting methods should be undertaken if it is justified, and separating out the financials can greatly improve analysis for ascertaining to what extent individual business activities are contributing to profit. Practices should also be mindful that the root cause of profit problems is, more often than not, revenue. Lastly, there should be thoughtful consideration when cutting expenses.

From the article of the same title
Physicians Practice (12/12/18) Morgan, Laurie
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What's Ruining Medicine for Physicians: Paperwork and Administrative Burdens
Eight out of 10 doctors rate paperwork and administrative burdens as the top challenge they face, according to the 2018 Medical Economics Physician Report. Much of this burden is a result of changes in recent years, notably the advent of value-based care. Physicians report spending more time in front of the computer than spending time with patients and having to sift through hundreds of pages of data to find important information. Others report being torn between what doctors believe is right for their patients' care, what the patient's insurance will cover and what the pharmaceutical companies will allow them to prescribe.

One way for physicians to ease the burden is to have patients pay cash for medications. Kyle Varner, MD, an internist at the Tripler Army Medical Center in Hawaii and author of White Coat Cartels, often suggests that patients whose insurance company requires prior authorization take this route because it will simplify the process and is cheaper than they think. Another route is to rely on technology. The future of healthcare operations and clinical delivery is expected to improve thanks to enhancements to technology that will decrease paperwork and administrative burdens. Some of what is expected to help are increased machine learning, natural language processing and artificial intelligence in day-to-day care delivery.

From the article of the same title
Medical Economics (12/12/18)
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Health Policy and Reimbursement

FDA Withdraws Proposed Rule on Generic Label Changes
The U.S. Food and Drug Administration (FDA) has withdrawn a proposed rule on label changes for generic drugs after concerns were raised by commenters and agency resources were considered. The rule would have allowed abbreviated new drug application (ANDA) holders for generic drugs to independently update and quickly distribute revised product labeling to reflect newly acquired safety-related information, even if the revised labeling may temporarily differ from that of the corresponding brand name drug. According to FDA, the rule aimed to improve communication of newly acquired drug safety information to healthcare providers and to the public.

The agency said some stakeholders expressed concern that temporary labeling differences between generic drugs and for the corresponding brand name drug could complicate healthcare decision making. Others raised policy, legal liability and cost questions. The generic drug industry group, the Association for Accessible Medicines, has said the proposed rule could increase generic drug costs by $4 billion per year.

FDA officials said they chose not to take an action that could lead to unintended adverse consequences, "including a risk that generic drug manufacturers would raise prices to consumers to absorb the cost of the new regulation." Moving forward, FDA said it is continuing to consider ways to improve the communication of newly acquired drug safety information to healthcare professionals and the public and to facilitate efforts to keep drug product labeling up to date throughout the product lifecycle.

From the article of the same title
Regulatory Focus (12/13/2018) Brennan, Zachary
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New Bill Would Halt Device Tax for Five Years
The House Ways and Means Committee is considering a bill to enforce a five-year suspension of the medical device tax, which med-tech associations say would give industry enough time to plan research and development strategies. The medical device tax issue has been particularly topical, partly thanks to trade associations and physician groups calling for its full repeal. Signatories stated that the tax had cost the jobs of more than 28,000 employees of device makers and cited changes in outcomes related to devices, such as a 60 percent reduction in mortality for stroke and heart disease.

Rep. Kevin Brady (R-Texas) stressed that the bill includes nearly 250 technical corrections to the tax reform legislation signed by President Trump in December 2017, but he also noted "it's irresponsible to wait until next year to deliver crucial tax relief" to those affected by this year's fires, floods and other disasters. According to Advanced Medical Technology Association CEO Scott Whitaker, the five-year moratorium on the tax "will help unleash new, life-changing technologies, heightened job creation and economic growth."

From the article of the same title
Medical Device Daily (12/12/18)
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Senate Democrats Introduce Bill to Allow Government to Block Drug Price Rises
U.S. senators have introduced a measure that would permit the government to prohibit drug price increases that it does not think are justified. Sponsored by Sens. Richard Blumenthal (D-CT), Kamala Harris (D-CA), Amy Klobuchar (D-MN) and Jeff Merkley (D-OR), the bill would permit the U.S. Department of Health and Human Services to block excessive drug price increases. In the House, Rep. Nancy Pelosi (D-CA) has said that next year's agenda includes dealing with the issue of high and increasing prescription drug prices.

From the article of the same title
Reuters (12/13/18) Bartz, Diane
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Medicine, Drugs and Devices

FDA Finalizes Rule to Simplify Medical Device Classification Procedures
The U.S. Food and Drug Administration (FDA) has issued a final rule to simplify its procedures for classifying and reclassifying medical devices. FDA said the final rule clarifies that it can reclassify any device from class III—set for higher-risk devices or those automatically assigned to this category by operation of law in lieu of classification orders—to either class I or class II.

The final rule, proposed in 2014, does not affect set procedures for a device reclassification via a submitted request. However, it makes it easier for the agency to make changes on a classification based on new or changing information to better reflect the risk associated with the use of a device. This is partly because administrative orders are not subject to the extended comment periods that accompany proposed rulemakings.

By aligning its regulations to the Food and Drug Administration Safety and Innovation Act of 2012 through the final rule, the agency can now move to reclassify a postamendments device or a transitional device by publishing an administrative order in the Federal Register. Convening a panel to consult on a device reclassification is now optional, but comments can be submitted on a proposed order. The final rule also removes the requirement to provide two forms as part of a device reclassification petition because FDA "no longer finds the forms useful," the agency said.

From the article of the same title
Regulatory Focus (12/13/2018) Mulero, Ana
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ISMP Analysis Suggests Overall Decrease in Reporting Drug Name Confusion; Increase in Generic Drug Name Confusion
Reports of generic drug names being confused have climbed in recent years, a trend that is expected to continue as the number of these medications increases, according to a retrospective analysis from the Institute for Safe Medication Practices (ISMP). Researchers examined name-related medication errors submitted to ISMP between 2000 and 2004 and 2012 and 2016. ISMP found that reporting of drug name confusion overall has declined over time: they found 816 reports of drug name confusion in the 2000–04 period versus 603 reports in 2012–16.

However, reports of confusion involving two nonproprietary drug names (generic-generic) increased from 27 percent of total reports in the earlier period to 61 percent in the later period. Meanwhile, reports of confusion involving two proprietary drug names (brand-brand) fell from 62 percent to 30 percent. That shift could be attributed in part to the rise of U.S. Food and Drug Administration (FDA) and manufacturer testing of brand names prior to approval. ISMP recommends that FDA, the United States Pharmacopeia and the United States Adopted Names Council partner with industry leaders to develop a standard evaluation method for nonproprietary names to be used before generic name assignment.

From the article of the same title
ISMP News Release (11/29/18)
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Medical Device Vulnerabilities Continue to Plague the Industry
As healthcare organizations grow more interconnected, common cyberthreats are finding their way onto machines, new research shows. Almost one fifth of provider organizations in a recent survey by the College of Healthcare Information Management Executives (CHIME) reported that their medical devices were affected by malware or ransomware in the past 18 months. Although the survey notes that few of these instances resulted in compromised protected health information (PHI) or an audit, the threats could affect continuity of care or PHI security.

The vast majority of providers point to the manufacturer as the cause of many of these device-related security issues, with out-of-date operating systems or the inability to patch devices seen as primary factors. But even where it is possible to improve security internally, 76 percent of providers said their resources were "insufficient and too strained to adequately secure medical devices." The U.S. Food and Drug Administration (FDA) is taking steps to improve the situation, including plans for a new framework for enhanced coordination and information sharing about medical device cybersecurity vulnerabilities and threats.

Meanwhile, providers can take several steps to help safeguard systems from vulnerable devices. According to Dennis Morley, director of strategic healthcare sales at CDW, a flexible security strategy is key, "allowing for the addition of new personnel, new devices or updates to old solutions" where necessary. Moreover, layering security solutions can help protect systems even if hackers manage to exploit a vulnerability. Managing patches can also greatly reduce vulnerabilities and the number of breaches.

From the article of the same title
HealthTech Magazine (12/11/18) Van Wagenen, Juliet
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This Week @ ACFAS
Content Reviewers

Brian B. Carpenter, DPM, FACFAS

Caroline R. Kiser, DPM, AACFAS

Britton S. Plemmons, DPM, AACFAS

Gregory P. Still, DPM, FACFAS

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This Week @ ACFAS is a weekly executive summary of noteworthy articles distributed to ACFAS members. Portions of This Week are derived from a wide variety of news sources. Unless specifically stated otherwise, the content does not necessarily reflect the views of ACFAS and does not imply endorsement of any view, product or service by ACFAS.

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