July 25, 2018 | | JFAS | Contact Us

News From ACFAS

New Clinical Session Available in e-Learning Portal
Surgical complications and failures can put even the most seasoned foot and ankle surgeon’s skills to the test. Watch ACFAS’ latest free Clinical Session, “Bail Me Out! (Surgical Misadventures),” for guidance on how to recognize the potential for complications and failures in your cases and how to address these issues should they occur.

Presentations in this Clinical Session include:
  • Can You Permanently Fix My Bunion – This Time?
  • My Toe Won’t Touch the Ground
  • I Thought You Were Giving Me an Arch
  • Missed Syndesmosis Injuries
  • What Is a Complication?
Complete a short CME test after you watch these presentations to earn 1.5 continuing education contact hours. Visit the ACFAS e-Learning Portal to access this Clinical Session as well as monthly podcasts, Surgical Techniques videos, e-Books and more for convenient next-level learning that is always ready when you are.
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Join Our #KeepYouOnYourFeet Social Media Campaign
Where have your feet taken you so far this summer? Show us in ACFAS’ #KeepYouOnYourFeet social media campaign!

We want to show how foot and ankle surgeons help keep people “on their feet” and active. Be part of this initiative by sharing photos of your feet hard at work, on vacation, exploring the world or just living day-to-day life. Use #KeepYouOnYourFeet in your social media posts and also encourage your patients to post photos of their feet on the move with the #KeepYouOnYourFeet hashtag.

If you would like ACFAS to post your photos on the College’s social media pages, email your photos to along with your name, the location or action in the photo and where you practice.

Follow the #KeepYouOnYourFeet campaign on ACFAS’ Instagram page or on Facebook and Twitter, and help us raise awareness of the impact you have on patients’ lives!
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Make the Most of Free Resources on
Looking for quick, no-fuss ways to enhance your practice website or attract new patients and referrals to your office?, the College’s consumer website, is here to help. You can: is free to use and continually updated with new content. If you have any questions about how to use the free resources on, contact Jolinda Cappello, ACFAS communications manager, at (773) 444-1320.
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Foot and Ankle Surgery

A Comparative Study of Three Commonly Used Fixation Techniques for Isolated Medial Malleolus Fracture
In this study, researchers compared the three most commonly used fixation techniques for isolated medial malleolus fracture. They divided 90 patients with medial malleolus fractures into three groups. Group A included patients who underwent tension-band wire fixation, Group B included individuals who underwent partially threaded cannulated compression screws and Group C included patients who underwent fully threaded cannulated headless compression screws.

No significant difference was observed between the three groups in terms of age, gender, Body Mass Index (BMI), follow-up period and fracture type. Union rate for group C was significantly shorter than groups A and B. No implant failure or irritation occurred in group C, and this was statistically significant compared to groups A and B. However, no significant difference existed between groups A and B. No significant differences in the three groups according to the American Orthopedic Foot and Ankle Society (AOFAS) scoring system were reported. Patients with low BMI in groups A and B had a high rate of implant-related complications. A significant correlation existed between low BMI and implant-related complication.

The researchers concluded that union rate in the group of patients who underwent fully threaded cannulated headless compression screws was significantly shorter than in the other groups. The study showed that tension band wiring and partially threaded cannulated compression screws can cause irritation of soft tissues and pain over the hardware implantation site. Patients with low BMI are vulnerable to implant-related complications.

From the article of the same title
Joint Diseases & Related Surgery (08/01/18) Vol. 29, No. 2, P. 104 Kochai, Alauddin; Türker, Mehmet; Çiçekli, Özgür; et al.
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Results of Scarf Osteotomy Without Implant Fixation in the Treatment of Hallux Valgus
The aim of this study was to examine the costs, clinical and radiologic results and complications of hallux valgus surgery using scarf osteotomy, depending on the type of fixation (with or without screws).

Researchers evaluated 169 patients who underwent scarf osteotomy between January 2013 and August 2016. The patients were separated into three groups depending on the type of stabilization: A, 2 screws; B, modified with 1 screw and C, modified without implant. They assessed duration of surgery, additional procedures, pre- and postoperative hallux valgus angle (HVA) and intermetatarsal angle (IMA) on anteroposterior and lateral foot weightbearing radiographs, the American Orthopaedic Foot and Ankle Society (AOFAS) hallux-metatarsophalangeal-interphalangeal scale for the clinical assessment preoperatively and at the 12-month follow-up.

Both the average HVA (A: from 33.7 to 12.6 degrees, B: 35.0 to 13.2 degrees and C: 34.7 to 12.4 degrees) and IMA (A: from 14.9 to 7.5 degrees, B: 15.2 to 6.9 degrees and C: 15.5 to 7.8 degrees) decreased in all groups without significant intergroup differences. The average AOFAS score improved in all the groups (A: from 40 to 88 points, B: 38 to 89 points, C: 42 to 91 points). A similar complication rate was observed. In group C, the researchers observed a shorter time of surgery, and the procedure was the most cost-effective.

The researchers concluded that scarf osteotomy without implant stabilization was faster and cost-effective and gave comparable results, although it was technically demanding and required patient compliance.

From the article of the same title
Foot & Ankle International (07/13/2018) Liszka, Henryk; Gadek, Artur
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Use of Autologous Bone Grafting from Calcaneus and Interconnected Porous Hydroxyapatite Ceramic for Bone Transplantation in Rheumatoid Foot Surgery
Cancellous bone grafts from the calcaneus have been used for the foot and ankle as well as iliac bone graft, but little research exists regarding calcaneal bone transplantation in the field of rheumatoid foot surgery. In this study, safety and usefulness of calcaneal bone grafts, and combination with interconnected porous hydroxyapatite ceramic, was evaluated in rheumatoid arthritis foot surgeries.

Of six rheumatoid arthritis cases, three (talo-navicular joint fusion) used a calcaneal bone graft alone, and the remaining three cases (subtalar joint and talo-navicular joint fusion) used a combination of calcaneal bone graft and interconnected porous hydroxyapatite ceramic augmented with dense calcium hydroxyapatite for subtalar bony defect (1.5–2.0 cm) after the correction. After starting weightbearing or walking, there was no pain or skin trouble at the fusion and harvesting sites. All cases achieved bony fusion within six to 10 weeks. Japanese Society for Surgery of the Foot rheumatoid arthritis foot ankle score improved in all six cases. Furthermore, tibio-calcaneal angle, talo-first metatarsal angle and pronated foot index were also improved at latest follow-up in all cases.

The researchers concluded that autologous bone grafting from the calcaneus was safe and convenient even in rheumatoid foot surgeries. For larger bony defects, combination use with interconnected porous hydroxyapatite ceramic augmented with dense calcium hydroxyapatite was also useful.

From the article of the same title
SAGE Open Medical Case Reports (06/25/18) Hirao, Makoto; Ebina, Kosuke; Etani, Yuki; et al.
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Practice Management

Don't Let Billing Drag Down Your Patient Ratings
A new study in the journal Spine found that spine surgeons receive positive reviews for their skill and clinical outcomes on physician rating websites, but they are more likely to get negative comments on factors related to clinic staff, billing and wait times. "Online review scores for individual surgeons are not just based on surgical outcomes and bedside manner," says lead author Chester "Chet" John Donnally III, MD. "While these are by far the most important factors for providing great healthcare, other variables, such as the greeting from the front desk nursing staff, friendliness of the surgical scheduler and transparency in billing, are all factors that patients value and will write reviews about," he says.

About 90 percent of the online comments researchers analyzed were related to the surgeon's competence or surgical outcomes (type 1) or the surgeon's character and communication ability (type 2). In these areas, feedback was highly positive. The remaining 10 percent of comments were related to "surgeon-independent" factors, such as the office staff, office environment or billing (type 3). Ratings for these factors were significantly lower.

Donnally says that physicians are not to blame for billing and cost ratings, which depend on the insurance provider. Nevertheless, it is important that everyone—from the front office staff to the billing department—are aware of their impact on patient ratings and reviews. "In a profession that relies on referrals, the entire team must work together to maximize patient satisfaction," Donnally says.

From the article of the same title
HealthLeaders Media (07/18/18) Wilson Pecci, Alexandra
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HIPAA Compliance Tips for Small Medical Practices
Although large healthcare systems often make headlines for data breaches, small healthcare organizations should be just as diligent in shoring up their protections. Here are some tips to help you and your medical staff avoid data breaches. First, the U.S. Centers for Medicare and Medicaid Services mandates that organizations "implement policies and procedures to prevent, detect, contain and correct security violations." Thus, practices should carry out a detailed risk analysis to evaluate the current staff and product deficiencies and to create corrective measures.

In addition, practices should assign a staff member to train employees on HIPAA policies and procedures and spend time going over typical breaches. Hire an outside expert to help your organization with compliance support. These experts should set up monthly meetings with the business owners to evaluate your company compliance program and should work with your organization to identify cost-effective resources to keep your company compliant.

Furthermore, customize your internet toolbars with anti-phishing protection. These applications can run website checks and compare them to lists of known phishing sites and alert users. Finally, be suspicious of any email that asks you to enter or verify personal data through a website or by replying to the message itself. Practice groups and staff members should never reply to or click the links in such messages.

From the article of the same title
Medical Economics (07/18/18) Dike, Esq., Doris
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Mid-Career Development for Medical Practice Staff
Professional development discussions tend to focus on medical practice staff who are just entering the field, and on those who are at the end of their careers. However, mid-career development may be especially important for those individuals who are ready to advance their skill set to maintain peak performance, improve their marketability or prepare for a job transition. Christopher Lee, MPH, CPHQ, clinical solutions marketing manager for Family Health Centers of San Diego, finds that many small practices do not necessarily invest in further development of their staff—to their own detriment. "Many of them are just humming along doing the same things they've always been doing," he says. "[Career advancement] is something people need to take the initiative to do."

One recommendation for medical practice staff is to identify their skills gap. Ask bosses what areas in the practice are currently unfulfilled or need improvement. In some skill sets, such as medical billing or coding, it may make sense to pursue a higher certification or a next-level course. In addition, have a career advancement goal in mind. Talk to supervisors to see what opportunities may be available and what must be done to qualify for them.

Experts also recommend that staff should join professional medical associations for helpful resources, such as industry information, career advice, trend updates and job boards. Another benefit is the chance to find a mentor who can help staff develop their skills. Professional memberships also open the door to networking, which is another key strategy for career advancement. Finally, sometimes the best career move for medical practice staff is to take additional courses, whether in person or online.

From the article of the same title
Physicians Practice (07/13/18) Rosenfeld, Jordan
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Health Policy and Reimbursement

FDA Issues Action Plan for Biosimilars
The U.S. Food and Drug Administration (FDA) has released a plan to promote the development of biosimilars. The Biosimilars Action Plan is a key part of the administration's Blueprint to Lower Drug Prices, said FDA Commissioner Scott Gottlieb, MD. "Our plan is aimed at promoting competition and affordability across the market for biologics and biosimilar products," he said.

Gottlieb noted that although FDA has approved 11 biosimilars, only three are on the market in the United States "because litigation has delayed market access for biosimilar products that are, or shortly will be, available in markets outside the United States several years before they'll be available to patients here." He expressed concern about "branded drug makers [that] thwart competition by dangling big rebates to lock up payers in multiyear contracts right on the eve of biosimilar entry," as well as about volume-based rebates that could "encourage dysfunctional clinical treatment pathways."

The new plan seeks to improve the efficiency of the biosimilar and interchangeable product development and approval process; maximize scientific and regulatory clarity for the biosimilar product development community; develop effective communications to improve understanding of biosimilars among patients, providers and payers and support market competition by reducing gaming of FDA requirements or other attempts to unfairly delay market competition to follow-on products. Gottlieb said FDA will also be updating the Purple book and has issued its final guidance on biosimilar labeling, giving healthcare practitioners the information they need to make "informed prescribing decisions for their patients."

From the article of the same title
FDA News Release (07/18/18) Gottlieb, Scott
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Trump Administration Preparing Fix for Obamacare Risk Payments
A regulation under preparation by the Trump administration would permit the resumption of billions of dollars in payments to health insurers in the Affordable Care Act (ACA). The U.S. Centers for Medicare and Medicaid Services recently sent a rule to the U.S. Office of Management and Budget related to the risk adjustment program, which transfers money to insurers that take on sicker customers.

An administration official, who requested anonymity, said the rule is an avenue being debated to settle the legal battle that has held up the payments. The rule is labeled as an interim final rule, which would enable it to go into effect immediately. Health insurance industry groups had urged the Trump administration to issue an interim final rule for the risk adjustment program to resolve the legal dispute that had threatened to halt payments under the program. The risk adjustment payments, worth $10.4 billion last year, are part of an ACA program intended to help balance the insurance markets when some insurers inevitably get saddled with more expensive patients.

Insurers had warned they might need to hike Obamacare premiums for 2019 if the dispute was not resolved fast. The program transfers money from insurers with healthier customers to those with sicker ones.

From the article of the same title
Bloomberg (07/19/18) Tracer, Zachary
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Trump Administration Proposes Altering Rule on Drug Rebates
The Trump administration has proposed a rule that would limit current protections allowing rebates between drug manufacturers and insurers and pharmacy benefit managers (PBMs). The proposal comes amid administration efforts to implement a wide-ranging plan to reduce prescription medicine prices. The U.S. Department of Health and Human Services has sent the proposed rule to the U.S. Office of Management and Budget (OMB). Details of the proposed rule have not yet been made public, but its title on the OMB site addresses removing the safe harbor protection for rebates from the anti-kickback law. The anti-kickback law makes it illegal to pay an incentive for drugs or services that Medicare, Medicaid or other federal healthcare programs cover.

From the article of the same title
Reuters (07/19/18)
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Medicine, Drugs and Devices

FDA Expedited Approval Process Raises Concerns About Risks
Researchers have expressed concern that the U.S. Food and Drug Administration's (FDA's) expedited approval process for drugs intended to treat serious or life-threatening conditions leads to uncertainty about safety and efficacy. The findings from a new study published in JAMA "suggest that FDA's expedited review programs may invite greater risks than benefits," according to an accompanying commentary in the JAMA Forum.

The study examined all FDA approvals given Breakthrough Therapy designation from 2012 through 2017 and discovered that many of the 89 pivotal trials used as a basis for these approvals lacked randomization, double-blinding and control groups. They also often used surrogate markers as primary endpoints and had small patient cohorts. In addition, more than half of the approvals were based on the results of a single trial.

This leads to greater uncertainty, say the authors, adding it is unclear whether the results will persist over the long term, in a larger population or replicated in another trial, for example. If novel therapies are entering the market on the basis of evidence that is generally accompanied by greater uncertainty, "we must be committed as a clinical and scientific community to ensuring that high-quality, rigorous postmarket trials are conducted within a reasonable period of time," said study author Joseph S. Ross, MD, MHS, an associate professor of medicine at Yale University School of Medicine. Doing so, he said, "will resolve some of this uncertainty and will ensure that the drugs are associated with the benefit/safety profile that we expect based on the initial clinical studies, allowing clinicians and patients to make fully informed decisions about whether to use these novel treatments."

From the article of the same title
Medscape (07/18/18) Nelson, Roxanne
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FDA to Develop Importation Policy for Sole-Source Drugs
The U.S. Food and Drug Administration (FDA) announced it will work on a policy to ease the importation of certain sole-source drugs. "For certain critical medicines, where there are no blocking patents or exclusivities associated with the drugs, but where there is only a single manufacturer; conditions may develop that create significant barriers to, and ultimately threaten, patient access," said FDA Commissioner Scott Gottlieb. Those conditions include supply chain issues or dramatic price increases, which have a similar impact on patients as drug shortages, he said.

Gottlieb said FDA will put together a work group to develop specific policies around importing foreign versions of sole-source, off-patent/off-exclusivity drugs. Issues the work group will address include the statutory and regulatory considerations for implementing such a policy, how FDA will define disruptions and how the agency will guarantee that the imported drugs are safe, effective and have adequate labeling. The work group will also ensure that the policy does not discourage manufacturers from seeking FDA approval of additional versions of sole-source drugs, Gottlieb said. He also noted that any importation of foreign versions of drugs would be temporary "until adequate competition enters these categories."

The announcement was met with resistance from some industry groups, who called for different approaches to promote competition and argued that importing foreign versions of drugs would compromise patient safety.

From the article of the same title
Regulatory Focus (07/19/2018) Mezher, Michael
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Study Highlights Factors Linked with Persistent Opioid Use After Treatment of Hallux Valgus
Patient factors are correlated with new, persistent opioid use in individuals who underwent surgical treatment for hallux valgus, according to research presented by Fred Finney, MD, at the American Orthopaedic Foot and Ankle Society Annual Meeting. The researchers used an insurance claims dataset to identify 38,312 opioid-naïve patients who had surgical treatment of the hallux valgus with a distal or proximal first metatarsal osteotomy.

"Timing of the prescription mattered in this group," Finney said. "Those who refilled a preoperative prescription again in that 30 days prior to surgery were significantly more likely to continue using after three months. Additionally, the strongest modifiable risk factor was the initial dose they were given." The rate of new, persistent opioid use among all patients was 6.2 percent, according to the study. Researchers found that 90 percent of patients underwent distal metatarsal osteotomy. New, persistent opioid use was seen more in patients treated with a proximal metatarsal osteotomy.

Depression, anxiety, alcohol and substance abuse disorders and certain pain disorders were among the patient factors that independently correlated with new, persistent opioid use, according to results of logistic regression. Factors not correlated with new, persistent opioid use included age, gender and income. "New, persistent opioid use ranges from 6 percent to 7 percent among opioid-naïve patients undergoing elective bunion surgery, which makes this one of the most common complications in hallux valgus correction," Finney said.

From the article of the same title
Orthopedics Today (07/18) Jaramillo, Monica
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This Week @ ACFAS
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Mark A. Birmingham, DPM, FACFAS

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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