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THE IMPACT OF SEXUAL ABUSE OF BOYS

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CONTENTS || FEATURES

“In Other Words” with

Matthew Shlapack, MD

In the Modern Approach to Diabetic Management, What Does ‘Good Control’ really Mean?

PUBLISHER John Kelly jkelly@orlandomedicalnews.com ——————— AD SALES John Kelly, 407-701-7424

FEATURES

——————— EDITOR PL Jeter editor@orlandomedicalnews.com

COVER STORY The Impact of Sexual Abuse of Boys

——————— CREATIVE DIRECTOR Katy Barrett-Alley kbarrettalley@gmail.com

PHYSICIAN SPOTLIGHT “In Other Words” with Matthew Shlapack, MD

HEALTHCARE LEADER SPOTLIGHT. Pharma Pro Brings Experience to Digital Pill Company

——————— CONTRIBUTING WRITERS April Boykin Jay Cohen Mary Dort

EOCC MEDICAL CITY Attitude is Everything

HIPAA Audits: A Five Step Survival Guide for Healthcare Providers

10 11

Jan Edwards Dorothy Hardee, Michael C. Patterson Jeff Ramos James M. Scicchitano

Five Small Changes that Can Add Up to Big Tax Savings

Renee Taylor ———————

A Triple Play to Double Practice Income

Managing the Complicated Patient

Ergonomics 1001

ORLAND GRAND ROUNDS

NORTH CENTRAL FLORIDA & VOLUSIA/ BREVARD GRAND ROUNDS

SOCIAL MEDIA DIRECTOR Jennifer Cerna ——————— ADVENT UNIVERSITY INTERN Noelle Kelly ——————— CIRCULATION jkelly@orlandomedicalnews.com ——————— All editorial submissions and press releases should be emailed to editor@orlandomedicalnews.com ——————— Subscription requests or address changes should be emailed to jkelly@orlandomedicalnews.com

Orlando Medical News July 2020 is published monthly by K&J Kelly, LLC. ©2020 Orlando Medical News. All Rights Reserved. Reproduction in whole, or in part without written permission is prohibited. Orlando Medical News will assume no responsibility unsolicited materials.

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NOVEMBER 2020

THE IMPACT OF SEXUAL ABUSE OF BOYS BY JAN EDWARDS

We’ve all heard the words, either uttered by our parents, an uncle, grandparent or friends’ parents…. Man up, Don’t Cry! Be a Man, Pick yourself up, Don’t show emotions and we see our friends clam up, shut down and shrink back, being a little quieter than they were before. As kids, we didn’t get it – we were all told a similar story – Men are ‘strong,’ women are ‘weak,’ breeding an environment of silence and in many cases, abuse.

According to a CDC Study in 2006, 1 in 4 women and 1 in 6 men have been sexually abused before the age of 18. This means there are more than 42 million adult survivors of child sexual abuse in the U.S. and 73 percent of child victims do not tell anyone about the abuse for at least a year. Forty-five percent of victims do not tell anyone for at least five years. Some never disclose, (Smith et al., 2000; Broman-Fulks et al., 2007). Much like we talked about last month, the likelihood of you having treated a patient who has suffered sexual abuse is very high; given victims don’t disclose as they experience shame and guilt, men who have such experiences are less likely to disclose them than are females.1 Only 16 percent of men with documented histories of sexual abuse (by social service agencies, which means it was very serious) considered themselves to have been sexually abused, compared to 64 percent of women with documented histories in the same study.2 This is another silent crime happening in our communities and the long-term effects of not only experiencing abuse, having to hide and bury it deep down inside, can be devastating. If you recall, we referred to a CDC study from 2016 stating in the United States we spent over $124 Billion dollars on treating chronic illnesses that arose from untreated childhood trauma. You are now beginning to see a correlation with late term diabetes, heart disease, arthritis and other chronic illnesses. Why don’t we know about this? And an even

better question is, what are we going to do to not only interrupt the silence your patients may be suffering, what can you do now to help your male patients who may be exhibiting signs for future chronic illnesses or managing an undisclosed mental illness? Let’s start with a brief history of the ‘manly men’ syndrome or as we later coined it “toxic masculinity.” One of my favorite documentaries I invite everyone to watch with their family is “The Mask You Live In” because it addresses the beginning of, and impact of telling boys they can only have two emotions, happy or angry. Nothing in-between works for them or they’ll be called names. So, an 11-year-old boy, who has all the emotions of an 11-year-old girl, has only one way to display them that is ‘acceptable’ – anger. So, fights, arguments, bullying begins. They have no control of how it’s expressed. All they know is they can’t cry or show any other emotion that would be considered “weak,” otherwise, they are the next target. This began as far back as we can remember, when men were ‘trained’ to fight to protect the realm and women, cooked, gathered food, bore children and ‘kept the home fires burning.’ Men had to be strong, virile, show no weakness. Ever. And that has been passed on for generation after generation. Every culture has their version of it. Indigenous warriors had to run miles holding water in their mouth and learn to hunt to prove they’re were a man. In Africa, there were tribes 4

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NOVEMBER 2020

that circumcised their young boys publicly and then sent them out to kill a lion. It was all about hiding emotions, proving they were strong. We all carry that same DNA and generational trauma. This has greatly impacted our society and the willingness of men to disclose abuse or harm that has happened to them, because somewhere in the tiny recesses of their brain, they should ‘have known better’ or ‘done something to stop it’ from a societal perspective. Now we can start to see a pattern forming; millions of men have been traumatized, carrying that around in their cells, end up in your office wondering why they are having chest pains, on the verge of diabetes or high blood pressure with little to no family history of those diseases. Now, how do you, as a health professional, in 15 minutes have a patient open up about possible past experiences that may result in their current trip to your office? Great question which I’ll address here.

Ask questions If there is no family history of their current experiences, that is a GREAT place to start asking some additional questions. The ACE scores test is a great place to start – it takes minutes for them to answer and you’ll get better insight into what they may have never disclosed. Just like we coach parents to begin with a question or a fact...it’s safe, sharing a fact or a story to have someone open up. I recommend you and your team come up with appropriate questions for your practice and patient group. CONTINUED P.5

The Impact of Sexual Abuse of Boys

Here are some idea starters:

to look for in men and boys are similar to women, with some unique things to look for that will provide a space for you to ask additional question, so you can provide both the medical and mental wellbeing they deserve.

“I learned that childhood trauma can impact us as adult – in fact, the CDC did a study about it….” “I see you have no family history of diabetes, have you been under more stress than usual?” “Have you ever heard of ACE Scores, Adverse Childhood Experiences? We’ve discovered they actually impact us as adults in some interesting ways. Even the one everyone seems to deal with, divorce, affects our bodies…” Leaving space for them to fill in the blank and take the test. Simple questions can begin to have a patient open up and share. Almost every time I go speak, someone lingers and comes up to me at the end and says “you know, I’ve always wondered what it was called, what happened to me…now I know, thank you for coming to speak with us.” The one that breaks my heart is when they say “I never told anyone…” or “you’re the first person I’ve told.” The level of guilt and shame is magnified for men. With the societal expectations placed on them, it’s easy to understand why they wouldn’t share. It’s our job to educate you enough that you can begin to ask some new questions that may open up a new pathway to healing. Children that are victims of abuse or witnessed abuse are far more likely to fall prey to predators, both on and offline. The neuronal patters have altered as a child. There is a brilliant article from the National Institute of Health, The Neurobiology of Attachment to Nurturing and Abusive Caregivers that explores the deep recesses of the brain and how it deals with trauma, however, this one sentence summed it all up for me. “A child attaches to the caregiver regardless of the quality of care received, even if the caregiver is abusive and neglectful. While a neural system that ensures attachment regardless of the quality of care has immediate benefits, this attachment comes with a high cost. Traumatic experiences interact with genetics to change the structure and function of the brain, compromising emotional and cognitive development and initiating a pathway to pathology.” Remember 1 in 6 men are sexually abused. The brain of the abused child intertwines pleasure and pain. Trauma bonding is real. We are wired for love, connection and intimacy and if we don’t get it at home, we will find it. That can lead to being groomed and recruited into trafficking. Both on Social Media and video games is where predators go to recruit young men and boys, promising to help them up level or offer money for pictures. What’s interesting is according to the International Labor Office, Boys only make up about 5% of trafficking victims, while a study in New York said it’s make up between 35% - 46% of sex trafficking victims in the US. Labor trafficking is a whole other subset of human trafficking. Boys and men make up 90% of labor exploitation around the world according to the Counter-Trafficking Data Collaborative. If you love data, you could get lost in all the information they have, it’s insightful and eye opening. Now you have a little more insight to the reality of boys and men being victims of both sexual abuse and human trafficking, here are some signs

For Boys: • Appearing malnourished • Showing signs of physical injuries and abuse

onset of the illness. We can prevent these diseases and disrupt the cycle of abuse and exploitation. If you suspect a child is a victim call the Florida Abuse Hotline – 800-962-2873 There are resources for male survivors of abuse or trafficking. Here are a few: • Salvation Army – offers housing and support. • https://salvationarmyflorida.org/ domestic-violence-program/

• Poor physical or dental health  • Avoiding eye contact • Fearful of authority figures

• Male Survivor - https://malesurvivor.org/

• Untreated sexually transmitted diseases

• Powerful group that connects survivors with resources they need. Male survivor is dedicated to providing personalized support for men at every stage of the healing process.

• Aggressive or combative behavior (boys) • Disassociation • Pain in Jaw

• USIAHT Safe Home for Boys https://bit.ly/35SXBzg

For Men: • (some of the above, plus) • Seeming to adhere to script or rehearsed response • Lack of personal possessions • No ID • Living at place of employment • Tattoos/ branding on the neck and/or lower back • Fearful of authority figures/law enforcement “The number 1 preventable risk factor for mental illness and substance abuse, childhood maltreatment in all its forms, insidious or obvious, is a significant public health problem. A history of maltreatment is associated with a wide range of psychiatric disorders as well as stressrelated medical conditions such as heart disease and diabetes. The lifetime consequences of early maltreatment on mental and physical health amplifies the toll on individuals and families, whose lives are often disrupted, and on society at large due to the enormous direct and indirect costs of illness or less overt behavioral issues.”3 As a medical professional you know what to look for to treat heart disease and diabetes, now you can begin to learn the source of these diseases when there is no apparent reason for the

HEALTH CAREERS

USIAHT has the only safe home for boys that are survivors of human trafficking. The most important thing to remember, is the level of shame, guilt and fear that has covered up the experience. With some care and compassion, you can get them assistance they need. This conversation can save lives and renew hope for those who’ve lost it. I shared with a few male friends about the information I found writing this article. It gave me an opportunity to have very deep conversations regarding the impact of childhood trauma, how it affects the neural pathways and what to do about it. They are beginning to see things differently; that they are not broken, they didn’t do anything to deserve the abuse. Yes, it happened and now they have access to getting what they need to alter the patterns and get freed up from the experiences they are living. As a medical professional, you have the opportunity to be that daily with your patients. A few extra minutes, asking an additional question or two, can literally save a life. Thanks for being that for another. Source: 1, 2: https://cachouston.org/sexual-abuse/child-sexualabuse-facts/ 3: https://www.dana.org/article/the-abused-brain/

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“In Other Words”

PHYSICIAN || SPOTLIGHT

with Matthew Shlapack, MD

In the Modern Approach to Diabetic Management, What Does ‘Good Control’ really Mean? Dr. Matthew Shlapack is a Board-Certified Endocrinologist who has been practicing in Florida for nine years and has recently established his practice, Orlando Endocrinology, on Lake Underhill Rd. in Orlando.

‘normal’ range. A multitude of studies has shined light upon the reality, that strict glucose control is not without its risk. With this in mind, as providers, we are left with the open-ended question of what level of glucose control should we be striving to achieve? If uncontrolled diabetes increases the risk of diabetic complications and tight glucose control increases the risk of hypoglycemia with associated mortality, where is the proverbial Goldilocks zone? While the debate on this issue is still raging and probably will for some time, a consensus among medical professionals has begun to emerge. First and foremost is the realization that not all patients have the same target glucose range for optimal diabetic control. A newly diagnosed diabetic with no established complications, especially at a younger age, is still probably a candidate for tight glucose control. In contrast, an elderly patient, especially one with multiple comorbidities, is rarely a candidate for tight control. In practice, however, there is considerable “grey area” as not all patients fall into these two clear-cut extremes. What about middle-aged patients who already have a documented history of CAD? When trying to chart a path for these patients, I ask myself the question “what are the expected benefits of strict glucose control for my patient versus their risk associated with recurrent hypoglycemia?” Another important consideration among the medical community involves the methods for how we measure glucose control. While seeing an optimal A1C result brings satisfaction to both the patient and the provider, we must not lose sight of what the A1C is: an average. With the advent and increased implementation of continuous glucose monitoring (CGM), we are now able to see what providers have always really wanted to know, how much of the time do our patients spend with their glucose values where we want them. One development that cannot be emphasized enough, is that research has consistently shown us that the tools that we use to control glucose have a tremendous impact on the health of our patients. Medications such as SGLT-2 and GLP-1 agents have proven to be effective in staving off the progression of CKD and reducing cardiovascular events in those diabetics with mild preexisting renal disease and CAD. At the same time, concerns have been raised regarding the possibility of increased mortality with agents such as

Shlapack completed both his Internal Medicine Residency and his Endocrinology Fellowship at The University of South Carolina, School of Medicine, and was awarded his Doctor of Medicine from Ross University Medical School. He graduated from The University of Maryland, College Park with bachelor’s degrees in both Neurobiology, Physiology, as well as Psychology. During his years working in Florida, Shlapack has been part of several community outreach programs focusing on a range of endocrinerelated health issues. He specializes in a wide range of endocrine conditions, including diabetes, thyroid disease and cancer, osteoporosis, and parathyroid disease. “Being a physician means providing compassionate care with every visit and always staying at the cutting edge, to ensure that my patients benefit from the newest breakthroughs,” said Shlapack. In keeping with Dr. Shlapack’s passion for care, and continuing development of best practices, we wanted to use this space for him to discuss an updated approach to managing diabetes.

"In Other Words" with Matthew Shlapack In the Modern Approach to Diabetic Management, What Does ‘Good Control’ Really Mean? There was a time in the more distant history of medicine when the intentional bleeding of patients, a practice known as bloodletting, was considered a routine part of treatment for a range of medical conditions. Largely regarded as a crude and medieval practice today, the physicians who performed this procedure probably did have the best interests of their patients in mind. Fortunately, once it was determined that this practice was detrimental to the patient, it was abandoned. This example parallels our ever-changing body of knowledge regarding the best practices for the management of diabetes and the evolving target goals of blood glucose control. As a medical community, we have come a long way from the narrow focus of merely driving down the A1C into the

Glyburide and osteoporosis with medications such as Pioglitazone. On the subject of tools for glucose control, the development of insulin pumps and glucose sensors seem to be moving at the speed of light! Sensors are getting smaller and less expensive. Insulin pumps are becoming not only smaller but also smarter. On the surface, it can often seem that these advances make the treatment of diabetes even more complicated. As providers, it can be easy to get lost in the vast array of choices and competing brands. Especially in a world of direct to consumer advertising, it is challenging to make sense of what treatments are best for our patients. While acknowledging the complexities associated with the modern treatment of diabetes, it is important to remember that now, more than ever, we can do more to safeguard the health of our diabetic patients. The timeless adage ‘treat the patient, not the labs’ remains true. As providers, we want the very best for our patients. To achieve this, we must be willing to challenge the status quo and question ingrained practice patterns. As physicians, we must remain open and allow ourselves to accept new evidence and expand on our medical knowledge. In doing so, we can better promote the health of those patients who have been entrusted into our care.

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HEALTHCARE LEADER || SPOTLIGHT

Pharma Pro Brings Experience to Digital Pill Company Valerie Sullivan was recently appointed President and CEO of central Florida-based digital health company etectRx. With its roots at the University of Florida’s Innovation Hub, the company focuses on innovating medication adherence with the use of its patented technology, the ID-Cap™ System. Sullivan brings more than 30 years of experience in health care, having worked in the pharma, digital health and pharma services industries. She holds a Bachelor of Arts in Chemistry and Economics from College of the Holy Cross, and an MBA in Finance and Marketing from Northeastern University. Sullivan’s passion for creating meaningful, costeffective solutions across the health care ecosystem has brought her to etectRx. She takes the helm with the goal of driving better patient outcomes and enhancing digital health technology. The company’s advanced R&D, proactive treatment abilities and patient-friendly system are positioned to achieve these goals. Sullivan began her career at Pfizer, Inc., where she spent 16 years in a variety of roles. Since then, she has served as vice president and general manager of the Patient Service Center at Pear Therapeutics, a program she built from the ground up, and as the president of InVentiv Patient Access Solutions, a tech-enabled patient support services company. When not busy at work, Sullivan enjoys spending time with her husband and two children and loves to relax at the beach. She is an avid reader and focuses on the latest management and social science findings to leverage how to best excel in the business world. She also shares her management skills and advice with students as an adjunct faculty member at Bentley University. We talked with Sullivan about her leadership and management experience, and how her career in pharma will benefit etectRx as it scales its model from a start-up to a commercial partnership organization.

thinking and business acumen. I fell in love with Pfizer’s deep passion and commitment to help cure and resolve complex disease states. I was fortunate to experience other business opportunities related to pharma after my time at Pfizer, like running specialty pharmacies and an IT-oriented reimbursement services business helping patients get access to high cost specialty medications.

ingestible sensors, a wearable ID-Cap Reader, a mobile application for the patient and a custom dashboard for clinicians and pharmacists. Our ID-Cap System has the ability to help pharma in their R&D efforts by providing accurate data, as well as the potential to make trials less costly over the long term, with fewer patients needed in trials because of increased data accuracy.

Tell us about etectRx and how it is positioned to help the pharma industry with drug development efforts?

What is your advice to leaders in the digital health space?

etectRx has developed a novel digital pill technology that will help pharma companies evaluate adherence of their oral medications and use data on ingestion to correlate efficacy, side effects and optimal dosing in order to deliver the highest quality patient outcomes. The ID-Cap System is a Class II medical device that has been cleared by the United States Food & Drug Administration (FDA) for marketing in the United States. The ID-Cap System is comprised of ID-Capsules containing

Everyone needs to support diversity and inclusivity for better performance of their bottom line and their people. Early on in my career at Pfizer, I learned that diversity of thought was the best predictor of team success. As a leader, I place high value on the various perspectives of my team and encourage open lines of communication. While digital health companies are often on the cutting-edge of innovation and are very exciting places

CONTINUED P.9

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How did you get involved in health care? I majored in chemistry as an undergrad and started researching the intersection of science and business during my sophomore year. When pursuing my MBA, I stumbled upon a job posting for a pharmaceutical sales rep position with Pfizer. Being a drug rep in the early nineties was exciting because each new drug launch was considered a blockbuster (think Viagra, Zoloft, Lipitor). In my 16 years at Pfizer, I achieved 7 promotions, and it was there that I gained great foundations of strategic

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Attitude is Everything DOROTHY HARDEE

“What consumes your mind controls your life” … Anonymous We are reminded daily about COVID, unemployment, businesses closing, civil unrest, political issues and more. The focus on all that is wrong currently overshadows the positive things happening all around. Yes, there is good out there and it is time to change the lens in which we are viewing for our mental health and well-being. As a young mom, I empathized with the dilemmas my children encountered. Being the sounding board as they would vent was appreciated. But they both knew that in exchange for listening I also expected they brought a potential solution and steps to achieve. It was important they understood the actions that got them in the situation, took responsibility for the results and took time to find a solution rather than expect their parents to step in to fix the issue. You may agree or disagree with my method of parenting, but I can assure you that I have two adult sons that appreciate, respect and emulate this practice today. What does this have to do with changing the lens to focus on the positive? It means that we each must make a conscious decision to make a change and choose to focus on the good, passing it on along the way. A positive attitude when dealing with obstacles personally and professionally makes it easier to keep moving forward. It also allows you to enjoy your life more fully leading to career success and personal satisfaction in addition to helping others. Considering the pandemic, we saw many of our member businesses quickly pivot finding ways to support the community staying viable as a business. They made masks, shields and hand sanitizer to assist, when others panicked causing shortages. They provided meals to essential works and those less fortunate, inspiring others to join the efforts. Indeed, recently shared a few ways to keep a positive attitude:

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• Forgive others for their limitations • Focus on what you get to do instead of what you must do • Practice dealing with rejection Staying positive and giving back not only helps you feel good but is good for you physically and mentally. In fact, a study by the Cleveland Clinic proved it showing that the health benefits included: • Lowering blood pressure • Increased self-esteem • Less depression • Lower stress levels • Longer life • Greater happiness and satisfaction. CONTINUED P.9

• Push yourself to do more each day • Describe yourself and your life with positive words

• Try to make other people feel happy – A giving heart 8

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HIPAA Audits: A Five Step Survival Guide for Healthcare Providers BY JEFF RAMOS AND LEAM DEGNAN

If you ask any health IT security professional today about what keeps them up at night, a full-scale data breach is probably at the top of the list. With regulatory fines in the millions and data breach notification/mitigation costs at even higher amounts, data breaches represent one of the greatest financial risks that healthcare providers contend with today. And in light of the new HIPAA Omnibus Rules, health IT vendors now face some of the same challenges as healthcare providers Before the introduction of the most recent Omnibus Rules, providers used to get away with a lot. The old HIPAA rules were ex post, meaning a healthcare organization only got in trouble if something went wrong and was caught red handed. Now, Congress has added an ex ante enforcement mechanism as a side provision in HITECH which allows HHS’ Office for Civil Rights (OCR) to run periodic, randomized audits to determine an entity’s compliance with HIPAA. OCR has given healthcare providers an indication of what the most important compliance areas are, in addition to guidance on how to adequately prepare for the possibility of receiving an audit. Listed below are five crucial steps any provider to be proactive.

STEP 1: Get Organized The first thing any compliance or security professional should do is organize all HIPAA documentation on hand. This includes all policies and procedures, in addition to all PHI disclosure logs and security incident documentation. It seemed that many providers had the correct documentation in order, but many policies were found to be incomplete or very out of date. An incident response plan is not effective if it is 10 years out of date and having and outdated plan is just as bad as not having one at all.

STEP 2: Perform a Security

Risk Assessment

In a recent Compliancy Group Webinar, over 80 percent of providers reported that their organization had not performed a security risk assessment within the past three months. Not performing the mandated Security Rule risk assessment was one of the biggest HIPAA compliance points of failure in the OCR pilot audit program. In fact, the OCR has referenced that these risk assessments are one of the most important pieces of a HIPAA compliance program. Currently, any provider organization that fails to document annual security risk assessments will be strictly scrutinized. So, what does an organization need to include in its assessment? At the most basic level, organizations must assess its potential risks and vulnerabilities to the confidentiality, integrity and availability of electronic Protective health Information.

STEP 3: Implement Risk

Mitigation

It is the actual process of following up on the gap analysis with a documented plan that truly signifies Security Rule compliance. A certain of Security Rule domains were singled out as areas which Covered Entities faced the greatest difficulty proving compliance. Below are a few of the lack of compliance:

• Contingency planning & backups (18 percent of audited entities implicated) • Media movement & destruction (14 percent of audited entities implicated) • Audit controls & monitoring (14 percent of audited entities implicated) • Access management (14 percent of audited entities implicated) • Risk analysis (12 percent of audited entities implicated) Document and come up with a clear plan to resolve.

STEP 4: Review Business

Associate Agreements

A Covered Entity must be able to show that it has entered into such agreement with all of its Business Associates in order to survive an audit. As the Omnibus Rule also made clear, Business Associates have an obligation to enter into BAAs with their subcontractors that handle PHI. As the HIPAA audits are expected to roll out to cover Business Associates, these entities must also make sure they are laying the proper framework to survive an audit.

STEP 5: Include Training While it is not necessarily required by either HIPAA or the audits, a smart training program will also include a more detailed security awareness training specific to the organization. Such extra training not only broadens a workforce’s knowledge in an increasingly important risk area, but also helps gather information that might not have been accessed otherwise. Organizations that employ this tactic frequently get workforce members to follow up with questions or initiate side conversations notifying the organization of a security concern that may only be visible at that employee’s level. The audits represent an opportunity for compliance and security professionals to ensure that they have the ear of their organization’s decision makers when constructing plans to keep patient data safe. Individuals that follow the appropriate preparation steps and work with their management teams to make sure their concerns are given top priority will place their organizations in a great position to survive an OCR audit. Jeff Ramos is President of Elevate Medical Resources and Leam Degnan is an associate with Compliance Group. Email Jeff@elevatemedicalresources.com

CONTINUED ...

Pharma Pro Brings Experience to Digital Pill Company to work, the atmospheres can be intimidating. Leaders in our field have to work to simplify complicated digital technology. Young people should know that our industry needs good people who can think strategically, be intellectually curious and try to take something complicated, like a digital pill, and create clear communication around it. I can always find a role in my company for those with an outstanding work ethic and good communication skills as well as strong strategic thinkers and those who are intellectually curious to drive team results.

What are your hopes for the future of health care and how do you see fitting into that future? For too long, health care has been reactive. A patient gets sick and visits a doctor. The doctor tries to fix the patient’s illness and the patient listens to clinical advice. The system is incentivized to fix a problem, however, I am passionate about a health care system that spends more proactive time on wellness and patient empowerment. Patients have the ability to take hold of their health and be engaged in their personal treatment plan. Our hope is that we will play a significant part in showing patients how taking their medications as directed can help them get the best outcomes. They are engaged by their clinician using their smart phone, making health part of their daily routine. Our role is giving patients confidence and control and engaging them in their treatment regimen.

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Attitude is Everything Ready to take the first step to a healthier, more positive outlook? Join the East Orlando Chamber on November 11th from 11:00 AM – 1:00 PM for our annual Local Charities Luncheon, featuring Beat Kahli, President and CEO of Avalon Park Group. He will share his story of philanthropy, its impact on charities and the community, as well as the value your support will offer our five highlighted nonprofit organizations: American Cancer Society; Black Orlando Tech; CareerSource Central Florida; Embrace Families; Harbor House of Central Florida. Learn more about each and fulfill a small but significant need displayed on our Giving Tree during the event. Our “Lights, Camera, Action” theme will put a spotlight on the needs giving you a chance to be part of something bigger. Start your holiday season off right. Register today. The Local Charities Luncheon, “Lights, Camera, Action” is November 11, 2020 from 11:00 AM – 1:00 PM at Holiday Inn East – UCF Area. Tickets are $35 for EOCC members and $40 for nonmembers. Help us make this season bright for all those these nonprofits serve in OUR community. For more information call (407) 277-5951 or visit our website at eocc.org. The East Orlando Chamber of Commerce everywhere East of I-4. Dorothy Hardee is the administrator of the East Orlando Chamber of Commerce

ORLANDOMEDICALNEWS.COM

NOVEMBER 2020

Five Small Changes that Can Add Up to Big Tax Savings We typically only think about taxes when preparing to pay Uncle Sam.

With over $25 trillion in public debt, imagining tax rates being lower than they are today is hard. Many professionals believe that they will be in a lower tax bracket in retirement when they are no longer commanding large salaries. Again, think about what your current income is going to be like. If you are maximizing contributions to a defined benefit plan that could double once, twice, possibly 3 times before you reach retirement, the required minimum distributions will likely keep you in the highest tax brackets. Even if you are in a “lower” tax bracket than you are currently, the tax due on a larger taxable distribution could still mean more dollars being paid to cover your tax liability. Instead, consider creative ways to fund Roth IRAs and other future tax-free buckets of income.

Making small changes to how you look at and approach your finances and taxes throughout the year, however, can add up to big savings on your taxes. There are many strategies that can be used, but here are five just to get you started.

1. Review Your Financial Reports Regularly reviewing your business’ financial reports on a regular basis may seem obvious. But surprisingly many people go through the act of making sure their reporting is in order without actually reading the reports. The reports are essential for effectively setting goals, ensuring you are meeting your goals, and understanding what your tax responsibilities are and will be on an ongoing basis so that you have a clear picture of your business’ health.

5. Contribute to Your Favorite Charities Donating to your favorite charity can be fulfilling and beneficial for you personally and for your business. Some charities prefer monetary

2. Defer Income to the Following Calendar Year All income received on or before December 31 is taxable for that calendar year. Based on your financial reports, determine whether you can afford to shift income from revenue until after January 1, reducing your taxable income for the calendar year. This small change, however, relies heavily on the financial reports that are discussed above. Before making the decision to shift income until the following year, make sure that you have the resources necessary to close out the month and year.

donations – think American Cancer Society or the United Way – but others accept food, clothing, toys, and other goods. In addition to being a good steward of the community, any donation you make is tax deductible for the fair market value of the items donated. The biggest small change you can make that can add up to big savings, however, is to make tax planning a year-round process so that you can minimize your tax liability for the year by planning ahead. Tax Saving Professionals offers advanced tax saving strategies for business and medical professionals seeking to keep more of what they earn by highlighting powerful solutions to build and preserve their wealth. For more than twenty years, we’ve helped thousands of clients around the country save millions of dollars in taxes. We work with business owners and high-net worth individuals that meet the accredited investor status to save them up to 50% on their taxes – year after year. If you’d like to learn more about how Tax Saving Professionals can help reduce your tax burden, we’d love to hear from you. Contact Randy McGaha at randy.mcgaha@taxsavingpros.com.

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Just as deferring income in December can help you save on taxes by reducing your taxable income, making large purchases in December – which can be written off as a tax deduction – can also help you save big on your taxes. Do you have equipment that needs to be upgraded or can you stock up on office supplies? Do you have vendor payments that you can make in advance? Again, however, if you choose to make purchases in advance, review your financial reports to ensure you have the means to make the purchases.

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4. Think About Retirement Differently Conventional wisdom tells you to maximize contributions to IRAs, 401(K)s and other retirement plans. While that may save taxes in the current year, you have to ask yourself, “How long until I retire? What will tax rates look like then?”

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ORLANDOMEDICALNEWS.COM

NOVEMBER 2020

A Triple Play to Double Practice Income Combining CCM/RPM and Medication Management with Little or No Upfront Investment, and No Overhead If you’re a physician in your own practice, most likely you have experienced some significant challenges over the past few months.

to home or a care facility, and dramatically reducing acute care readmission rates.  Medication Management - How do you know what your CCM patients are really taking? Four out of five patients fail to mention important OTCs, skip doses, take family member’s medications, or use illicit drugs. These factors can lead to misdiagnosis, dangerous adverse drug events, and contribute to 100,000 deaths annually. Relying on a report from the pharmacy is only half of the battle. You can mitigate these issues with next generation precision urine testing. Results include a full report that automatically flags inconsistencies for your CCM team to know about - and follow up on. “When you combine all three of these services you will be on the cutting edge of medicine - and your patients will feel more engaged and cared for,” adds Hazelgren. This breakthrough technology is making a huge difference to the health of patients. The combined services in the Triple Play program can be replicated successfully in your practice and provide you

If you have plans to increase your practice revenue and build a legacy practice, you’ll want to read more. Brian Hazelgren consults with physicians around the globe on how to increase practice efficiencies and revenue. He reveals the first time ever combined “Triple Play” essential components of healthcare and the movement that is disrupting and positively impacting healthcare in a huge way. A Triple Play in baseball is a rare, magical moment when teamwork, skill and timing all combine to deliver a beautifully harmonious 1-2-3 sequence! This Triple Play program combines CCM/RPM/ Medication Management to work together to enhance patient care and substantially increase revenue to your practice. The entire goal of combining these three services is to provide improved care for your patients by - keeping them out of the ER and dramatically cut down on acute care readmissions. “There are practices bringing in $200,000+ annually with just 300 Medicare patients on this program,” states Hazelgren.  Chronic Care Management (CCM) Medicare CPT Code 99490 — provides a new stream of revenue of $42* (national CMS average) or more per patient per month. A team of care coordinators works with your Medicare patients to record and archive an electronic record of 20 minutes or more of non-face-to-face visits with your patients. This service was launched by CMS in 2015 and is really catching fire and improving patient care.  Remote Patient Monitoring (RPM) - is an easy and natural add-on to your CCM services for your Medicare patients. It is a great benefit to them in multiple ways. Using digital technologies to collect physiologic health data from patients and electronically transmitting that information securely to the health care provider for assessment and recommendations - is a great service to your patients. Your practice will also generate new streams of income through RPM. Health professionals monitor patients remotely and act on the information received as part of the treatment plan. This type of service allows a provider to continue to track healthcare data for a patient once released 11

ORLANDOMEDICALNEWS.COM

NOVEMBER 2020

with more free time and a better experience for your patients. Your patients will be impressed with how simple the program is for them while achieving significantly improved results. This is an essential addition to your practice to add the most impressive business system and structure. There is a distinct advantage for you to be first in your area to implement these services - because only one provider’s NPI number is associated with the patients ID. There is less than 6 percent of eligible Medicare patients on the system today, but it is catching fire and many new patients are being enrolled daily. Don’t miss your opportunity to take advantage of money on the table! Brian Hazelgren is CEO of RX2Live - a medical services and practice management company. Brian is a Best-Selling author and speaker, and has helped medical professionals generate over $1.3 Billion in new income streams over the past two decades. To learn more about these medical services bundled together for physicians, you can reach Brian at bhazelgren@rx2live.com or visit www.rx2live.com. Rami Packard is a Regional Developer for RX2Live and assists the growth of medical practices and helps keep their patients well. She also assists with senior and corporate wellness programs. Visit https://livewell. rx2live.com/ or contact her at rpackard@rx2live.com Tom and Mary Dort are co-owners and Southwest Florida Regional Directors of Rx2Live in Cape Coral. Tom formerly was VP of Innovation and Development for Avgol Nonwovens which made nonwoven substrates for disposable hygiene and medical products. He can be reached at TDort@Rx2Live.com. He can be reached at TDort@Rx2Live. com. Mary Dort has been a Registered Nurse for 35 years and serves as a Medical Business Consultant to medical practices, elder care facilities, dental practices and businesses interested in implementing Health and Wellness programs. She can be reached at mdort@rx2Live.com

Managing the Complicated Patient are often misunderstood or overlooked at the onset because they can be hard to assess in high functioning patients. They can look like complaining, anger, somatization, or demanding behaviors.

BY APRIL BOYKIN, MSW, LCSW

Studies have consistently shown that approximately 15 percent of all patient encounters are “difficult” (Hinchey, et. al, 2011).

How your patients will benefit from integrated behavioral health services:

• Overcoming roadblocks • Building problem solving skills • Improving communication skills

• Cognitive Decline-As patients experience cognitive decline, we frequently field questions about the same things over and over while seeing a decrease in compliance and an increase in frustration.

Beyond the complex medical diagnoses, people who are sick, injured or overwhelmed have less ability to access their coping skills and can be even more challenging to deal with. Patient complications come in many forms such as behaviors that are resistant, clingy, somatic, complaining, help-rejecting, manipulative, demanding and entitled, or those who are simply “frequent flyers.” What is most important to know is these behaviors are all evidence of greater issues that can be managed or improved with the use of integrated behavioral health support. The effects of challenging patient behaviors can be overwhelming. These patients take up a disproportionate amount of time, can burn out our staff, can compromise our compassion towards them, and can ultimately become too difficult to manage. Everyone has a right to be an active participant in their own care, but when complicated patients’ behaviors create roadblocks to their own medical care it can become an ethical dilemma for their providers. Finding a solution is critical for the wellness of the patients and the efficiency of our offices. When patients demonstrate these complicated behaviors, they are really signaling depression, anxiety, lack of trust or satisfaction, or even worsening of symptoms. There is an established correlation between complex behavioral and emotional symptomology and poorer health outcomes which negatively impact provider reimbursement. What is going on? The underlying issues that result in difficult patient encounters likely include one or more of the following:

• Behavioral changes • Resolving emotional turmoil, and trauma resolution • Setting up realistic expectations for emotional and physical wellbeing

• “Better than Average” Effect - These patients typically make decisions based on seeing themselves as better than they are and will stay at home often long after they should have moved into a congregate living situation putting more of a burden on medical providers because of an inability for self-care.

• Creating routines for diet, exercise, sleep and taking medications • Developing relaxation and stress management techniques • Experiencing emotional support and a focused space to express emotions

• Unexplained symptoms or unresponsive to treatment-Patients who present with atypical symptoms or don’t get better in the way they want begin to doubt the medical profession, they become less-complaint and present as angry, resistant, demanding etc. • Social determinates-Many of our patients may be living without access to medications, food, or a safe or stable environment, etc. This can be embarrassing to discuss and result in noncompliance, anxiety, frustration and negativity. How Integrated Behavioral Health Services Help: Counselors are great partners in addressing these issues with patients and helping them access or develop effective coping skills that will decrease the frequency of stressful patient encounters in the office. Integrated behavioral health services improves health outcomes, and ultimately prevents reimbursement loss due to premature rehospitalization.

• Anxiety-From panic attacks to worry and hypervigilance, anxiety creates ruminating thoughts. Patients seek soothing, which results in an increase in calls and appointments, as well as somatization.

• Processing of emotions related to distress and discomfort • Building social connections • Identifying community resources that patients may be eligible for • Collaboration on psychotropic medications • Setting up medication delivery • Assessment and care planning Counselors are trained and skilled at addressing all aspects of a person’s physical, behavioral, and emotional functioning, including complex presentations. If this article has made you think about a complicated patient you work with, refer them for support today. April Boykin is a Licensed Clinical Social Worker and cofounder of Counseling Resource Services (CRS). Established in 2013, CRS is a communitybased in-home integrated behavioral health agency serving the aged and disabled population in Central Florida. As a mental health counselor, she has provided individual, family and caregiver counseling to children, teens and adults. She can be reached at april@counselingresourceservices.com

• Depression-From agitation and irritability to apathy and disengagement. Depression causes patients to be less compliant and engaged in recommended treatment process. • Personality Disorders-With a skewed perspective, patients with personality disorders are more likely to feel entitled and be demanding of your time and attention. With a lower tolerance for discomfort these patients become high utilizers. • Unrealistic Expectations-Expecting that chronic pain will disappear, or that treatment improves symptoms immediately, these beliefs cause patients to return frequently or request premature treatment changes. • Isolation-Loneliness and fear can make patients more dependent on attention, guidance and connection from medical providers. • Delusions/Hallucinations and Paranoia-These 12

ORLANDOMEDICALNEWS.COM

NOVEMBER 2020

Ergonomics 1001 BY DOUG MINTZ

There are three primary furniture components to address ergonomics in the workplace. • Task chair for very specific applications. In general, monitor arms are the best solution and most prudent, especially with the advent of the flat monitor.

• Adjustable height monitor arm • Fully adjustable keyboard tray Often when addressing ergonomics, one can go back to the old joke about the patient at the doctor’s office. The doctor raises his left arm and asks the patient “does it hurt when you do this?” The patient says “yes – exactly!” Without missing a beat, the doctor says, “then don’t do that!” More often than not, ergonomic challenges are the result of improper setup of a workstation. In the workplace most employees are assigned a desk, a chair, and a computer. After that, they are on their own. The personal computer is the number one piece of office equipment that has created present day ergonomic challenges. The typical office employee spends over half of their time in front of a computer screen. Repetitive motions can cause stress and strain to several body components: eyes, neck, wrists, lower and upper back. Ergonomics brings many of these factors into balance. The idea is to have all these physiological components in neutral positions.

Keyboard Tray The keyboard tray should then be adjusted around this neutral sitting position as well. In most cases, the keyboard height is below the work surface height and almost in the lap of the user. It should also have a tilt feature so it can be set in a slightly negative tilt, again, an extension of the neutral forearm and hand positions of the user from their original task chair orientation. So, a quick review of ergonomics 1001:

• Adjust the task chair and be sure you are sitting flat footed and in a neutral position. • Adjust both the monitor height and tilt to minimize eye and neck strain. • Adjust the articulating keyboard tray to minimize wrist and arm strain. So, what is the investment for an ergonomically sound work area? It depends. Cost of a task chair of reasonable quality with some adjustability will start at $175.00. On the higher end, to enjoy all the features and benefits, if needed, and lifetime warranties, upper range cost will approach $500.00. Keep in mind that if a single user is occupying in this workstation, depending on their specific ergo-

Task Chair Proper ergonomics all start with the task chair. The task chair is the most important component of ergonomics. It should be fully adjustable, so the user is sitting in a comfortable and neutral position. Feet should be positioned flat on the floor. The back height and tilt angle should be adjusted so there is ample lumbar support for the lower back. Adjustable arms should be in a position that support the forearms, so they are parallel to the ground or at a slightly negative tilt relative to the keyboard tray. The wrist positions should then follow suit to the negative tilt of the forearms. The user should now be sitting in an upright and neutral position (Remember when Mom always told you to “sit up straight” at the dinner table? As always, Mom was right). The other ergonomic components should then be adjusted around the neutral sitting position of the user.

nomic needs, an entry level option may accommodate them just fine. Ideally all employees should be assessed individually. Many companies may offer two or three seating options for their employees just for this reason. A single monitor arm with some basic maneuverability will start around $145.00. Depending on height range, vertical and lateral adjustability features, and number of monitors capacity, the investment can go as high as $675.00. Mounting features can also drive cost, whether the unit is clamped on to a worksurface, mounted through a desk grommet, hung from the wall (hospitals and medical facilities), or hung from a cubicle panel with proprietary hardware. Keyboard trays also are available with a wide range of features and benefits, depending on a user’s needs. A basic metal keyboard drawer that slides out on a smooth ball bearing mechanism can be purchased for as little as $130.00. Fully articulating models with swivel, tilt, palm gel support, and quick-release features top out at $375.00. In summary, the budget for a complete ergonomic setup including a chair, tray, and monitor arm will fall in the range of $450.00 - $1,550.00. Doug Mintz has been in the office furniture industry for over 20 years. After working three years for a family-owned dealership, Mintz ventured out on his own in 2001 and founded CPOF Inc – Cubicles Plus Office Furnishings. CPOF quickly differentiated themselves in the marketplace by providing project management services and other value-added benefits for clients in the mid-market; services that were normally offered only by larger contract furniture dealers ($10 Million +). His focus is primarily on the patient’s waiting room experience, as well as the ergonomic health and wellbeing of clinic employees. Visit www.cubiclesplus.com or email Doug@CubiclesPlusOF.com

Monitor Arm The monitor arm should be adjusted at a height and angle that keep head and eye movement to a minimum. The user should be able to look straight ahead or slightly downward to view the monitor; this ensures the maximum support of the head and reduces eye strain and neck strain. There have been different schools of thought regarding monitor heights. Desks have been designed that house the monitor underneath the worksurface and are angled upwards. The user views the monitor through glass that replaces a portion of the worksurface. This setup is the exception, not the rule. It’s used

ORLANDOMEDICALNEWS.COM

NOVEMBER 2020

ORLANDO || GRAND ROUNDS

Center for Digestive Health Announces Three New Physicians Dr. Xinjun Zhu is a gastroenterologist from Albany Medical Center, New York, where she was an Associate Professor of Medicine and Director of Center of Inflammatory Bowel Disease (IBD). Zhu’s endoscopic expertise includes upper endoscopy, colonoscopy, chromo-colonoscopy, enteroscopy, Bravo pH test, capsule endoscopy, esophageal manometry, percutaneous endoscopic gastrostomy, etc. She was also a principal investigator for the competitive IBD research and clinical trials supported by National Institute of Health, pharmaceutical companies, foundations and philanthropists. Her work has been disseminated in many premier journals and book chapters. She was invited as a speaker for various international conferences. Zhu completed her internal medicine residency training at The George Washington University in Washington D.C. This was followed by a fellowship training in Gastroenterology and Hepatology at Johns Hospital of The Johns Hopkins University in Baltimore. Zhu is board certified in gastroenterology following internal medicine. She is a fellow of the American Gastroenterological Association and the American Society for Gastrointestinal Endoscopy, and a member of Crohn’s and Colitis Foundation. She has been serving on the Food and Drug Administration Advisory Committee Division of Gastroenterology and Inborn Errors Products since 2012. Dr. Ivelisse Lopez was born and raised in Puerto Rico, where she also pursued her Pre – Medical and Doctor’s degree at the University of Puerto Rico Rec into de Ciencias Medicas. She obtained her specialty in Internal Medicine at Barnes-Jewish Hospital in St. Louis, MO and her Gastroenterology – Hepatology, and Nutri-

tion fellowship at MD Anderson Cancer Center University of Texas Houston. Central Florida has been her home since 2001. Her medical career has been highlighted by more than 10 years of private practice, while being the Chief of Gastroenterology at Orlando Regional Medical Center and worked as the Chief of Gastroenterology at the Orlando VA Medical Center. Besides performing the regular endoscopic procedures (upper endoscopy and colonoscopy), she also performs others like capsule endoscopy, manometry, and ERCP. Dr. Ehsan Rafiq earned his medical degree from King Edward Medical University. He completed his Internal Medicine residency at The University of Toledo where he was later appointed as Assistant Professor of Medicine. He then proceeded to do his fellowship in Gastroenterology at the University of Toledo and served as chief fellow in his final year of fellowship. He later moved to Orlando for his Advanced Therapeutic Endoscopy fellowship at the Center for Interventional Endoscopy at Florida Hospital. Rafiq practices all aspects of general gastroenterology including inflammatory bowel disease and liver diseases with special interest in pancreaticobiliary disorders and advanced therapeutic endoscopy. His procedural expertise includes Endoscopic Ultrasound, therapeutic ERCP, endoscopic ablation and resection of Barrett’s esophagus, endoscopic mucosal resection of large polyps and double balloon enteroscopy. Rafiq is board certified in Internal Medicine and Gastroenterology. He is a fellow of American College of Physicians and a member of American Society for Gastrointestinal Endoscopy, American College of Gastroenterology and American Gastroenterological Association.

Orlando Health and UCF Athletics Join Forces UCF Athletics and Orlando Health are coming together for a transformational long-term partnership that delivers all the resources of the area’s most comprehensive healthcare network for the Knights’ athletic teams and student-athletes – designating Orlando Health as the official medical provider for UCF Athletics. With this new partnership, physicians at Orlando Health Jewett Orthopedic Institute will coordinate care for UCF student-athletes through the Orlando Health network of complete medical services. UCF student-athletes will have access to comprehensive, world-class medical care, including emergency care, primary care, pulmonology, spine specialists, neurologists, cardiologists, physical therapists, athletic trainers and more. “This community has been energized by UCF Athletics, and in caring for UCF student-athletes for many years, our team of specialists has had the pleasure of seeing that excitement up close,” says Michael Jablonski, M.D., physician lead with Orlando Health Jewett Orthopedic Institute. “With our team of world-class orthopedic specialists at Orlando Health Jewett Orthopedic Institute, our leading sports medicine program, and the wide network of high-quality care we have to serve our community, there’s no doubt in my mind we’ll be able to continue building on the winning culture established here at UCF.”

Under the agreement, Orlando Health will provide medical care for the 500 student-athletes competing in 16 sports under UCF Athletics. In addition, Orlando Health personnel, resources and medical expertise have been devoted to UCF Athletics since the onset of COVID-19 – particularly in crafting strategy for dealing with realities of the virus once UCF student-athletes began returning to campus in June. “UCF Athletics already has benefitted tremendously, and in a variety of ways, from this partnership during this unique COVID-19 pandemic,” says UCF vice president and director of athletics Danny White. “Our comprehensive efforts to attack and deal with the realities of COVID-19 as our teams train and compete could not happen without Orlando Health.” The specialists at Orlando Health Jewett Orthopedic Institute will lead the physicians and athletic trainers caring for UCF student-athletes on the field during competition, in the training room, and in Orlando Health clinics. “The Knights are Orlando’s hometown team and in Orlando Health we have a partner who has been in this community for more than 100 years and is as committed to its well-being as we are,” says White. “Having Orlando Health by our side absolutely helps our student-athletes succeed and continues the growth of our program and our University.

ORLANDOMEDICALNEWS.COM

NOVEMBER 2020

ORLANDO || GRAND ROUNDS

Lake-Sumter Medical Society Announces New Membership Level The Lake-Sumter Medical Society has announced an Associate Membership level for Doctors of Podiatric Medicine and Doctors of Dental Medicine and Dental Surgery. Sheyla Zelaya, MD, President of the Board of Governors, announced this recent change to the by-laws welcoming colleagues in the podiatric and dental professions, pointing out that “the addition of Podiatrists and Dentists as Associate Members will benefit everyone, including patients.” Prospective Associate Members have access to benefits, meetings, social events, CME’s and exclusive referrals. Download an application from www.lakesumter.org or email frontdesk@lakesumter.org. For more information call 352742-9902.

AdventHealth Begins Recruiting Participants for Phase 3 COVID-19 Vaccine Trial AdventHealth will be a testing site for the Janssen Pharmaceutical Companies of Johnson & Johnson’s Phase 3 clinical research study, ENSEMBLE trial, to evaluate the safety and efficacy of Janssen’s investigational COVID-19 vaccine candidate, JNJ-78436735, also known as Ad26.COV2.S. The Phase 3 randomized, double-blind, placebocontrolled clinical trial is designed to evaluate the safety and efficacy of a single vaccine dose of the Janssen COVID-19 vaccine candidate versus placebo, in approximately 60,000 adults 18 years old and older, including significant representation from those that are over 60. The trial will include those both with and without comorbidities associated with an increased risk for progression to severe COVID-19. AdventHealth will enroll up to 4,500 adults aged 18 and up from across Central Florida. To support the recruitment process, Janssen has developed the ENSEMBLE Study website where people interested in volunteering for the study can register. All

registration information will be collected, handled and stored according to the local laws and regulations. Following registration, the research centers will evaluate volunteers’ information and then potentially request physical tests before the volunteer is included in the study. The ENSEMBLE website also brings details on the trial, such as medical monitoring and a questions and answers section. Janssen has joined other pharmaceutical companies in making a pledge to the world that it will continue to adhere to its high scientific, ethical and regulatory standards and will rely on robust clinical evidence to guide the development of its investigational COVID-19 vaccine candidate. Janssen is committed to transparency and sharing information related to the Phase 3 ENSEMBLE study – including the study protocol. Janssen’s investigational COVID-19 vaccine leverages Janssen’s AdVac® technology. The same technology was used to develop Janssen’s European Commission approved Ebola vaccine regimen and is the basis

for its HIV, RSV and Zika vaccine candidates. To date, more than 100,000 individuals have been vaccinated with a Janssen AdVac®-based vaccine. ENSEMBLE is being initiated in collaboration with the Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). More information about the trial is available at AdventHealthVaccineTrials.com.

NORTH CENTRAL FLORIDA || GRAND ROUNDS

Tiniest Baby to Ever Survive at Orlando Health Winnie Palmer Hospital Goes Home After 6 Months "It's a bittersweet day for us in the NICU," said Dr. Thais Queliz, neonatologist at Orlando Health Winnie Palmer. "We're sad to see Diana leave, since she and her parents have been with us for so long. But we're so proud of how far she's come and are happy for them to start their lives at home as a family of three." Her miraculous journey home comes at such a fitting time, as November is National Prematurity Awareness Month. According to the University of Iowa's Tiniest Baby Registry (which keeps a running list of reported cases of smallest surviving babies), Diana will join a group of only 10 babies in the world recorded to have survived at her size and gestational age.

Baby Diana Peguero is one of the smallest and most premature babies in the world to survive and thrive. She entered the world as the ultimate Mother's Day surprise on May 10, 2020 at Orlando Health Winnie Palmer Hospital for Women & Babies, when her mother was just 22 weeks pregnant. She is considered a "micro-preemie," born weighing 350 grams (12 ounces) and nine inches long. After examining her size and development, her medical team came to believe that she may have actually been younger than 22 weeks, as gestational age is just an estimate. The odds were against Diana, as most babies born this early and small have a near-impossible chance of survival. Miraculously, she never needed any life-saving surgeries – just time and care from the team of experts in the neonatal intensive care unit (NICU). Diana has grown to over 7 pounds, becoming the most premature surviving baby to ever graduate from the hospital's NICU. Parents Federico and Jomary are thrilled to finally take their first and only child home after spending nearly six months traveling to and from their home in Ocala, Florida to be with Diana. For Federico, her homecoming is extra special as he celebrated his birthday on November 5.

ORLANDOMEDICALNEWS.COM

NOVEMBER 2020

NORTH CENTRAL FLORIDA || GRAND ROUNDS

AdventHealth elevates patient safety in ambulances with Aeroclave AdventHealth is raising the bar on safety for patients in need of emergency care. AdventHealth has deployed expanded use of Aeroclave in all of its ambulances. Aeroclave is an aerosol disinfectant that creates a fine, dry mist that covers the entire inside of the ambulance, providing decontamination for COVID-19 and other viruses after each patient is transported to a facility. AdventHealth West Florida Division ambulances are able to be disinfected and returned to service in less than 30 minutes. “It is imperative, especially now, that we take all measures possible to keep our patients, team members and community safe during the COVID-19 pandemic. The implementation of Aeroclave allows us to continue providing the kind of innovative and leading-edge safety we are nationally recognized for in our facilities,” said Dr. Robin McGuinness, Senior Executive Officer of Patient Outcomes, AdventHealth West Florida Division. AdventHealth West Florida Division acquired 10 units of the disinfecting system thanks to the AdventHealth Foundation West Florida and generous community members who donated to the Community Care Fund. This fund provides lifesaving equipment, supplies and resources to AdventHealth team members and patients during the COVID-19 pandemic. Aeroclave reduces staff and patient exposure to viruses such as COVID-19 and provides a faster turnaround process, which doesn’t delay patient care. AdventHealth is consistently ranked as a top healthcare system for patient safety by the prestigious LeapFrog Group which ranks hospitals on effectiveness of lowering infections and keeping patients safe.

UF Health Enrolls First Patient in Clinical Trial Aimed at Creating New Treatment for COVID-19 University of Florida Health has enrolled its first patient in a clinical trial for the Regeneron Pharmaceuticals’ monoclonal antibody cocktail to treat COVID-19, a therapy that might neutralize the coronavirus and prevent it from infecting cells. UF Health is one of hundreds of medical centers internationally participating in the blinded, placebo-controlled, randomized clinical trial to determine if these synthetic antibodies can lessen the severity of coronavirus infection, shorten hospitalizations and reduce mortality. Mark L. Brantly, M.D., principal investigator of the trial at UF Health, said researchers also are attempting to calibrate the most effective dosage for patients. Brantly said researchers across UF Health are working furiously to find treatments for COVID-19, the disease caused by the coronavirus. They are all too mindful of the lives lost to the disease. Such randomized trials are the gold standard in clinical research, and findings from such work offer the best opportunity to reveal a treatment’s effectiveness. Blinded testing means patients do not know if they receive the drug or a placebo. UF Health hopes to enroll at least 20 hospitalized patients who are intermediately sick or progressing to a critically ill state. Combined with other medical centers, total enrollment is hoped to reach 2,970 patients during this Phase II trial. Brantly said it is important to note that monoclonal antibodies, if they are effective, will not eliminate the disease. The trial involves what are essentially designer antibodies. They can battle invaders in several ways. For Regeneron’s cocktail, it is hoped that the antibodies can bind to the spike proteins on the coronavirus and, like a house key unable to enter a lock because it’s wrapped in a wet piece of chewing gum, prevent the virus from entering susceptible cells. “These are specific areas on the spike protein that bind

to areas of the cell surface membrane and sort of ring the doorbell so that the cell lets the virus in,” Brantly said. Regeneron has developed two lines of synthetic antibodies that, through testing in humans and animal models, have shown the most promise in being able to neutralize the virus. One line comes from laboratory mice whose immune systems have been genetically modified to mimic a human’s. The second line is derived from humans who have previously been infected by COVID-19. Developing two antibodies, each targeting a different area of the coronavirus, increases the odds that the cocktail might still be effective if the virus mutates slightly. It’s not a new therapy. Monoclonal antibodies, for example, have been developed to fight certain types of cancer. Monoclonal means the antibodies have been cloned from a single, ancestral cell. If the antibodies block the coronavirus from binding to cells, it might reduce the viral load carried by an individual, Brantly said. The infective form of a virus outside a cell is called a virion. Preliminary evidence in an earlier, smaller trial indicates the patients who might benefit the most from Regeneron’s monoclonal antibodies are those whose bodies have not yet mounted their own antibody defense. “It is possible it is more helpful in people who have not mounted their own immune response,” Brantly said. “But this is very preliminary evidence that needs to be confirmed.” He expects the trial to continue through the fall. But if the U.S. Food and Drug Administration grants Regeneron emergency use authorization for the drug, that could complicate things as it might make it more difficult to enroll patients. Patients could receive the drug without being in a trial.

VOLUSIA/BREVARD || GRAND ROUNDS

Elioe E. Burgos, MD Joins Halifax Health – Pediatrics, Deltona Elioe E. Burgos, MD, a board-certified pediatrician, has joined the medical team at Halifax Health – Pediatrics, Deltona. Dr. Burgos has been practicing pediatric medicine for over 20 years. Prior to joining Halifax Health – Pediatrics, he was a physician at Halifax Health Medical Center, Emergency Department. Burgos is excited to join the Halifax Health – Pediatric Care team.

Halifax Health – Pediatric Care physicians are passionate about educating families, because knowledge is power. As a partner in care, we teach families not only about illnesses, but also about growth, behavior and development, to help them raise happy, healthy children who grow into happy, healthy adults. Knowing that every child is unique, our providers offer personalized guidance, support and advice for each family.

Shirley Yacoub, MD, and Nally Calzado, MD, Join Halifax Health – Primary Care Deltona Shirley Yacoub, MD, and Nally Calzado, MD, both board-certified family physicians, have joined the medical team at Halifax Health – Primary Care Deltona. Dr. Yacoub earned her medical degree from Ain Shams University. She completed her internal medicine internship and family residency at West Virginia University School of Medicine. She worked as a hospitalist at Charleston Area Medical Center prior to joining Halifax Health. Dr. Yacoub’s clinical interest is treating complicated cases with multiple co-morbidities. Dr. Calzado earned her medical degree from Stony Brook School of Medicine. During her medi-

cal education, she was involved in various outreach activities within her community such as free clinics and was honored with induction into the Gold Foundation for Humanism in Medicine Honor Society. Dr. Calzado completed her family medicine residency at Halifax Health Medical Center. She is bilingual in Spanish and English. Halifax Health – Primary Care physicians have extensive training and experience in treating adults, children, adolescents and seniors. Services offered include physical examinations, routine vaccinations, adolescent healthcare, women’s health and preventive medicine, and sick visits, as well as health education.