News From ACFAS

---

Last Friday, November 30, ACFAS eligible voting members received an email from the College’s independent election firm (acfas.ballot@intelliscaninc.net) with a unique link to the 2019 Board of Directors Election website. If you are a Fellow, Associate, Life or Emeritus member, please take a few minutes to cast your vote for your elected leadership. Your vote is important to advancing our profession and surgical specialty.

If you have not yet voted, two more reminder emails will be sent to you before the election closes on Monday, December 17, 2018. If you do not have a valid email address on file with the College or your email system blocked the test email from our election company, watch your U.S. mail for voting instructions. The clock is ticking—just seven days remain until special early bird pricing for ACFAS 2019 ends! Head to acfas.org/neworleans by December 12 to save $85 or more on your registration fee and to secure your spot at the profession’s most anticipated event of the year.

ACFAS 2019 will take place February 14–17, 2019 at the Ernest N. Morial Convention Center in New Orleans. Be sure to also book your hotel room when you register and consider coming down to New Orleans on February 13 to take part in brand-new preconference workshops and our inaugural Residents’ Day. Your patients may think foot pain during pregnancy is unavoidable, but our latest infographic, Enjoy Pregnancy Without Foot Pain, offers quick tips to help alleviate three of the most common foot issues experienced during pregnancy—swollen feet, arch pain and ingrown toenails.

Download this new infographic now from the ACFAS Marketing Toolbox and:

• Post it on your practice website and social media sites
• Distribute copies to your patients and referring physicians
• Display it in your office

Also customize the box in the lower righthand corner of the infographic with your contact information so patients can easily reach you.

Visit acfas.org/marketing now for more free infographics and products to boost your year-end practice marketing efforts. And don’t forget to add the ACFAS Logo Store to your holiday list to show pride in your College membership! Apparel and gifts available in the store include:

• Dress and casual shirts
• Fleece jackets and baseball caps
• Scrubs and surgical caps
• Coffee mugs and water bottles
• Professional pens
• Hoodies, t-shirts, socks and more!
  (Clothing is available in a variety of colors and sizes.)

The ACFAS Logo Store is your 24/7 one-stop shop. Visit anytime to check out all the new products, make your purchases and provide payment. Show off your pride in YOUR professional association, and have the happiest of holidays!

Foot and Ankle Surgery

---

A retrospective cohort study was conducted at an urban level I trauma center to compare medial malleolus-first fixation of unstable ankle fractures with lateral malleolus-first fixation. A cohort of 280 adults with operative bimalleolar ankle fractures from January 2010 to January 2015 met inclusion criteria. The medial-first group had more open fractures and fewer isolated injuries, and fewer isolated operative procedures and more intramedullary screw placement of the lateral malleolus, than the lateral malleolus-first group. The medial-first group also tended to have more posterior tibial tendon injuries. The researchers observed no significant differences in fluoroscopy times or radiographic factors in the preoperative, intraoperative or most recent postoperative images between either group. They concluded that this strategy demonstrates equivalent radiographic outcomes to lateral-first fixation and may be appropriate in select cases.


The Ponseti method represents an intervention option for untreated congenital clubfoot in children older than walking age. A metanalysis was conducted of observational studies selected through a systematic review of articles included in electronic databases until June 2017. A pooling analysis of proportions with 95 percent confidence intervals and a publication bias assessment were performed as routine. Estimates of success, recurrence and complication rates were weighted and pooled using the random effects model. Twelve studies, including 654 feet diagnosed with congenital clubfoot in children older than one year old, were included for analysis. The rate of satisfactory outcomes found via a cluster metanalysis of proportions using the random effects model was 89 percent, relative to the total analyzed. The recurrence rate was 18 percent, and the rate of casting complications was 7 percent. The researchers concluded that application of the Ponseti method in children with untreated idiopathic clubfoot older than walking age leads to satisfactory outcomes, has a low cost and avoids surgical procedures likely to cause complications.


With a rise in antibiotic-resistant bacteria, it is important to evaluate use of antibiotic chemoprophylaxis in foot and ankle surgery. Reduced surgery time, decreased incision size and smaller internal fixation devices may differentiate foot and ankle procedures compared to other bone and joint surgeries. The objective of this study was to systematically evaluate the quality of evidence behind existing guidelines.

A systematic literature search was performed from 1990 through March 2018. The inclusion criteria were studies exploring perioperative antibiotic use, postoperative infection rates in elective foot and ankle surgery and studies evaluating antibiotic use in clean elective foot and ankle surgery. A total of 11 studies met the inclusion criteria. Two level one studies, four level two studies, five level three studies and four level four studies were included for review. Results of surgical site infection rates found within this systematic review ranged from 0 percent to 9.4 percent of overall postoperative infections following foot and ankle procedures.

The researchers concluded that although fragmented, aspects of antibiotic chemoprophylaxis are established within fields of elective surgery with a growing body of evidence. However, evidence for specific antibiotic use in elective foot and ankle surgery is lacking.

Practice Management

---

Workplace violence is a serious issue in healthcare, but executives can implement strategies to help organizations prevent and prepare for violent incidents. First, it is important for staff to know their patients and talk to coworkers. People who commit violent acts against healthcare facilities are usually well-known to the people who work there. Staff should also be trained to recognize the nonverbal body language that can precede actual violence. If caught early, deescalation tactics can be used to intervene and defuse the situation.

Furthermore, having a "zero tolerance" policy and letting people know that violence will not be tolerated is a deterrent in itself. Installing locks and barriers might seem like a no-brainer, but many intake areas are still very vulnerable because they lack proper locks. Secure lightweight furniture, lamps and other items in waiting areas and patient rooms that could be wielded as weapons. Similarly, instruct staff members to leave jewelry at home or keep it in a locker. Establish designated safe rooms where staff and patients can go to escape if violence occurs, and regularly update lists of emergency contact numbers and communication plans.

Although many facilities are taught to run, hide and fight during a violent incident, healthcare settings are different because most healthcare personnel would not leave a patient's side during a shooting. "Avoid, Deny, Defend and Treat" is an alternative shooting response plan in use at Carolinas Medical Center in Charlotte, North Carolina. Only as a last resort should a staff member in a healthcare setting fight back. Finally, if you see something, say something. Most incidents go unreported, so healthcare staff should be encouraged to report incidents to supervisors and keep good paperwork.


A recent cohort JAMA study on physician burnout and regret found that 14 percent of second-year residents had career choice regret, while another survey found that 70 percent of doctors are unwilling to recommend healthcare as a profession. Characteristics associated with a higher risk of reported regret included being female and having a high level of anxiety in medical school, while those associated with a lower risk of career regret reported lower overall levels of empathy during medical school.

Maiysha Clairborne, MD, an integrative family physician and the founder of the website Stress Free Mom MD, has transitioned out of clinical medicine after 14 years. "Over the years, I have experienced waves of physician regret, not necessarily for choosing to be a physician specifically, but for the career path I chose as a physician in family medicine." Clairborne says career regret often comes from having an unrealistic view about what life as a physician will look like, as well as a system that involves tiresome interactions with insurance companies and copious amounts of paperwork, regulations and requirements.

Sylvie Stacy, MD, MPH, a primary care physician, runs an online community called Look for Zebras that is focused on helping physicians have fulfilling careers in medicine. Often, Stacy says, a nonclinical career is an excellent option for physicians who are experiencing regret or burnout. Pharmaceutical and managed care companies are likely the most popular options for a physician career pivot, Stacy notes, as well as healthcare consulting firms and public health, both local and federal. Medical writing, healthcare tech and software and app companies are also full of opportunities for physicians. "You don't have to leave medicine entirely if you have physician career regret. There are lots of opportunities to do other things within medicine," says Stacy.


Physician practices must ensure they have appropriate amounts of cyber liability insurance and enforced policies on old equipment storage and disposal as part of their risk management strategies. Practices should first secure equipment, then formulate a device security plan and assign someone to implement it. They should also keep records of all devices, sign out all users and physically disconnect devices from their network. It is a relatively standard business practice to take a tax deduction for donating safe electronic equipment after assuring no confidential information is stored on it.

Other devices posing security risks include scanners, printers and fax machines, which can store thousands of images and pages of data. Practices also need to consider professional IT support, including security software and online security training for personnel as obligatory, and to gauge their business insurance coverage for accidents, mistakes or data breaches. They should have seven figures in data breach/cyber liability insurance and seven figures in standalone "directors and officers" coverage.

Health Policy and Reimbursement

---

A new proposal from the Trump administration would allow insurers participating in Medicare's prescription drug program to exclude certain protected drugs if prices rise faster than inflation, with the goal of reducing prescription drug costs for seniors. "The lack of any ability for Part D plans to manage drugs in the protected classes has allowed the pharmaceutical industry to command high prices on protected class drugs in Part D, without patients getting a good deal," stated U.S. Centers for Medicare and Medicaid Services Administrator Seema Verma. Health plans would also be permitted to exclude certain new drug formulations that do not represent a "significant innovation" over the original product.

In addition, private Medicare plans would be allowed to apply prior authorization and step therapy, requiring that patients try more affordable drugs before turning to costlier ones, irrespective of their doctor's prescription. Trump administration officials claimed the proposal could add up to taxpayer savings of $692 million over 10 years. "By bringing the latest tools from the private sector to Medicare Part D, we can save money for taxpayers and seniors, improve access to expensive drugs many seniors need and expand their choice of plans," said U.S. Department of Health and Human Services Secretary Alex Azar.


The U.S. Department of Health and Human Services on November 28 released a draft strategy aimed at reducing administrative and regulatory burdens on clinicians stemming from use of health information technologies, including electronic health records (EHRs). The strategy seeks to limit the time and effort related to both regulatory reporting requirements and inputting patient information in EHRs, and to increase functionality and user-friendliness of EHRs. The strategy was developed by HHS Office of the National Coordinator for Health Information Technology in partnership with the U.S. Centers for Medicare and Medicaid Services to meet a requirement of the 21^st Century Cures Act.

"With the significant growth in EHRs comes frustration caused, in many cases, by regulatory and administrative requirements stacked on top of one another," said HHS Secretary Alex Azar. "Addressing the challenge of health IT burden and making EHRs useful for patients and providers, as the solutions in this draft report aim to do, will help pave the way for value-based transformation."

The draft strategy cites many sources of EHR and health IT-related burden, including misalignment of regulatory requirements and timelines across programs, issues accessing data and records becoming overloaded with extraneous documentation. The recommendations for reducing burden include waiving documentation requirements as necessary to test alternative payment models and harmonizing reporting requirements across federally funded programs requiring the same or similar EHR data from providers.


The U.S. Department of Health and Human Services (HHS) announced it will allow a rule imposing ceiling prices on the 340B drug discount program to go into effect on January 1, 2019, after years of delays. The change will cap the prices drugmakers can charge hospitals that participate in 340B. The American Hospital Association and several other healthcare trade groups sued the agency this fall to force it to finalize the regulations. HHS has previously said it needed more time to consider additional rulemaking to replace the Obama-era regulation with one drafted by the Trump administration, but has since changed its mind. "HHS does not believe that any further delay is necessary and is changing the effective date," the agency said. In addition, HHS noted that the start date will not interfere with any subsequent rulemaking it may release on 340B ceiling prices.

Both the American Hospital Association and 340B Health, also a hospital trade association, praised the move by HHS. "The final rule issued today is a big step toward stopping drug companies from overcharging 340B hospitals, clinics and health centers," said Maureen Testoni, interim president and CEO of 340B Health. Both groups urged HHS to move forward quickly with their plans to launch a ceiling price website to give providers the opportunity to check the prices they are paying.

Medicine, Drugs and Devices

---

U.S. Food and Drug Administration (FDA) officials said they plan to overhaul the system for approving most medical devices, seeking to make sure new medical devices reflect up-to-date safety and effectiveness features. "We believe that newer devices should be compared to the benefits and risks of more modern technology," said FDA Commissioner Scott Gottlieb, MD. He noted that the proposed changes would require companies to compare their products to more current technology, instead of referencing decades-old devices.

While new pharmaceuticals are tested in patient studies, most medical devices must only demonstrate that they are similar to other products already on the market. FDA's framework for approving medical devices, a system that dates back to 1976, has received widespread criticism. An Institute of Medicine panel recommended in 2011 that the "flawed" system be replaced, as it does not establish safety and effectiveness. Devices cleared through the 510(k) program include imaging scanners, computerized drug pumps, artificial joints and spinal implants.


No medical device has had more reported problems over the last decade than insulin pumps, a product used by hundreds of thousands of people living with diabetes globally, many of them children. Insulin pumps and their components are responsible for the highest overall number of malfunction, injury and death reports in the U.S. Food and Drug Administration's (FDA) medical device database, according to an Associated Press (AP) analysis of reports since 2008, yet problems with insulin pumps have not been well-documented or widely reported.

Medical device companies and many experts say insulin pumps are safe devices and blame user error for most reported problems, noting that the pumps are complicated devices requiring special training for patients. Over the last decade, insulin pumps and pump parts made by Medtronic Inc. faced 20 manufacturer recalls and approximately 100 lawsuits alleging pump malfunctions, according to a joint investigation by the AP and the International Consortium of Investigative Journalists. FDA's data offers no explanation for why the devices have so many adverse events.

Many of the reports filed by doctors, manufacturers and patients lack key information—a reporting failure that FDA acknowledges across all devices. An AP analysis of the FDA data found that Medtronic did not include a device problem code describing what had happened on virtually any of its more than 150,000 adverse event reports related to insulin pumps since 2008. FDA says that the number of pump recalls has declined over the last five years, however, which it attributes to a 2010 initiative aimed at increasing requirements for manufacturers and boosting user awareness.


The U.S. Food and Drug Administration (FDA) is seeing both a climb in drug shortages and an increase in the intensity and duration of shortages, according to agency presentations at a recent FDA/Duke Margolis Center for Health Policy event. Matthew Rosenberg, an economics staffer at FDA, examined the extent of drug shortages based on FDA archives and the IQVIA national sales database. He found that ongoing shortages have become more prevalent over the last year or so, and in terms of duration, shortages are more persistent now than was previously the case. In terms of intensity, more than two thirds of historical volumes have typically been unavailable for these drugs.

FDA Commissioner Scott Gottlieb said many of the critical drugs in shortage are sterile injectable drugs, and most of these drugs are longtime, generic medicines that are relatively inexpensive. Experts added that buyer and seller consolidation, along with low margins and contracting practices, can contribute to drug shortages. In some markets, prices may also be too low to sustain reliable supply and the necessary investments in manufacturing, according to Gottlieb. The Association for Accessible Medicines pointed out that FDA can influence changes around improving the existing expedited resolution pathway for drugs in shortage. "AAM believes FDA should permit generic sponsors to comply with new or updated standards as a post-market commitment to mitigate delays in access," AAM said. "New cGMP requirements and or enhancements to cGMP requirements should be provided via guidance rather than via 483s or warning letters."