Floridamd november 2014

NOVEMBER 2014 • COVERING THE I-4 CORRIDOR

Consulate Health Care Improving Care through an Enhanced Patient Experience

United in the

Fight Against Diabetes

Nationally Ranked Diabetes Care at Your Fingertips

Jorge Daaboul, MD Medical Director Florida Center for Pediatric Endocrinology, Diabetes and Metabolism

Damon Tanton, MD Medical Director of Clinical Practice, Florida Hospital Diabetes Institute

Steven Smith, MD Scientific Director Translational Research Institute for Metabolism and Diabetes

Richard Pratley, MD Medical Director of Education and Research, Florida Hospital Diabetes Institute

Breaking New Ground in the Fight Against Diabetes When your patients need treatment for complex endocrine disorders like diabetes, it’s nice to know you have access to the highest-ranked hospital for diabetes and endocrinology in the state of Florida. Florida Hospital is at the forefront of adult and pediatric diabetes diagnosis, treatment and education. We’re engaged in cutting-edge research, having been awarded research grants from the American Diabetes Association (ADA) and National Institutes of Health (NIH).

But what truly makes us special is the elite level of coordinated service provided by our four divisions of care.

Florida Hospital Diabetes Institute

Comprehensive education and support for patients with type 1 or type 2 diabetes

Florida Diabetes and Endocrine Center

Superior treatment for patients with prediabetes, diabetes, and other complex endocrine disorders from board-certified endocrinologists

Florida Center for Pediatric Endocrinology, Diabetes and Metabolism

Elite, highly specialized diagnosis and treatment programs for infants, children and teenagers with diabetes and other complex endocrine disorders Translational Research Institute for Metabolism and Diabetes

World-class translational research dedicated to scientific discovery and practical medical applications designed to ultimately cure diabetes, obesity and cardiovascular disease

Learn more at All4OneDiabetesCure.com.

Florida Hospital is ranked #13 in the nation

by U.S. News & World Report for Diabetes and Endocrinology.

MKTGPR-13-16420

contents 4

NOVEMBER 2014 COVERING THE I-4 CORRIDOR

 COVER STORY

Photo: PROVIDED BY CONSULATE HEALTH CARE

Consulate Health Care, a national leader in post-acute care, is forging the way to improved patient outcomes and interdisciplinary collaboration. As the sixth largest provider in the U.S., and the largest in the State of Florida, that is no small feat.

President and Chief Executive Officer Joseph D. Conte originally founded Tandem Health Care in 1997, with one center in Cheswick, PA. Under Conte’s leadership in 2006, Tandem grew into Consulate Health Care with seventy-eight centers in six states. Today, Consulate encompasses more than two hundred centers in twenty-one states, offering services ranging from comprehensive post-acute care and rehabilitation (including physical, occupational and speech/language therapies) to long-term skilled nursing, Alzheimer’s and dementia care.

Photo: PROVIDED BY CONSULATE HEALTH CARE

18 7 Reasons HospitalPhysician Mergers Hurt Health Care 20 Alzheimer’s Dementia--Is It Preventable?

DEPARTMENTS 2

FROM THE PUBLISHER

3

BEHAVIORAL HEALTH

9

PULMONARY & SLEEP DISORDERS

11 HEALTHCARE LAW 12 CANCER 14 FINANCIAL UPDATE: Insurance•Benefits•Wealth MGMT. 15 ORTHOPAEDIC UPDATE

16 MARKETING YOUR PRACTice 17 FOOT & ANKLE 22 DIGESTIVE AND LIVER UPDATE FLORIDA MD - NOVEMBER 2014

1

FROM THE PUBLISHER

I

am pleased to bring you another issue of Florida MD. We all have busy lives that seem to get busier every day. A lot of times we start to take for granted some of the things we should be most grateful for. This Thanksgiving I suggest we all take a moment to reflect on our lives and put

things in their proper perspective. I wish you all a happy, safe and healthy Thanksgiving holiday. Until next month…

Best regards,

Donald B. Rauhofer Publisher

Publisher’s Note: In the October edition of FloridaMD, Dr. Daniel T. Layish wrote an article about two promising drugs for idiopathic pulmonary fibrosis. As of October 16th, both of these drugs have received FDA approval, and they were both granted fast track, priority review, orphan product and breakthrough designation. Pirfenidone will be marketed under the trade name Esbriet by Intermune and Nintedanib will be marketed as Ofev by Boehringer Ingelheim. Both products are expected to be commercially available in Nov 2014. 

Coming UP Next Month: The cover story focuses on Compass Research, a clinical research company dedicated to testing investigational medications that cover a broad range of diseases and disorders. Editorial focus is on Pain Management and Occupational Therapy.

ADVERTISE IN FLORIDA MD

PREMIUM REPRINTS

For more information on advertising in Florida MD, call Publisher Donald Rauhofer at (407) 417-7400, fax (407) 977-7773 or info@floridamd www.floridamd.com

Reprints of cover articles or feature stories in Florida MD are ideal for promoting your company, practice, services and medical products.

Increase your brand exposure with high quality, 4-color reprints to use as brochure inserts, promotional flyers, direct mail pieces, and trade show handouts. Call Florida MD for printing estimates.

Email press releases and all other related information to: info@floridamd.com

2 FLORIDA MD - NOVEMBER 2014

Publisher: Donald Rauhofer Photographer: Donald Rauhofer / Florida MD Contributing Writers: Ann Alexander, Daniel T. Layish, MD, Jeffrey Phillips, MD, Ira Goodman, MD, Biff Kramer, DPM, Benjamin Newman, JD, Jamie Huysman, PsyD, S. Kyle Taylor, Jennifer Thompson, Marni Jameson, Corey Gehrold, Harinath Sheela, MD Designer: Ana Espinosa Florida MD is published by Sea Notes Media,LLC, P.O. Box 621856, Oviedo, FL 32762. Call (407) 417-7400 for more information.

Advertising rates upon request. Postmaster: Please send notices on Form 3579 to P.O. Box 621856, Oviedo, FL 32762.

Although every precaution is taken to ensure accuracy of published materials, Florida MD cannot be held responsible for opinions expressed or facts expressed by its authors. Copyright 2012, Sea Notes Media. All rights reserved. Reproduction in whole or in part without written permission is prohibited. Annual subscription rate $45.

Behavioral Health

“Care Comes Home” for National Family Caregivers’ Month COVER STORY

By James D. Huysman, PsyD, LCSW Hopefully you know by now, that November is National Family Caregivers’ Month. It’s an entire month devoted to the celebration of those who provide care for family members every day.

Do you know how many of your patients are family caregivers? You should, and they should be monitored closely for signs of compassion fatigue and burnout, because without them our entire long-term care system would collapse! You read it right; our long-term care system would actually collapse.

The latest figure posted by the National Association of Family Caregivers is that family caregivers now provide $577 billion in uncompensated medical care on an annual basis. Yes, it’s a staggering figure.

I’d like to send a special shout out to those of you who are professionals working in care occupations, as well as serve as family caregivers. You are the true heroes of this story. Without you we truly would be lost.

I challenge all MD’s, in honor of this month devoted to caregivers, realize that you are also and do one thing for yourself every day. You deserve it and you are worth it!

Dr. James Huysman, PsyD, LCSW, aka Dr. Jamie, is a fierce advocate of patient-centered healthcare. He is a popular conference speaker and media guest on caregiver

The ACA has 17 provisions for family caregivers in its text. Do you know what they are? More importantly have the medical facilities at which you have privileges implemented them according to the timeline? Healthcare has changed and it is necessary for us to stay ahead of the curve in order to provide basic medical needs

burnout, compassion fatigue and addictions and health-

The Caregiver Action Network now claims that there are 90 million family caregivers in the US; another sobering figure.

Without proper care, overwhelmed family caregivers end up in emergency rooms with illnesses that could have been avoided for the most part.

magazines. He co-founded the Leeza Gibbons Memory

Take care of our caregivers. Acknowledge their contribution to society. Urge them to identify as a caregiver and seek support where it is needed.

a four year period. He co-wrote the acclaimed book, Take

Please, take a moment to consider the impact of the family caregiver:

Gibbons and Dr. Rosemary Laird. He currently works

1. Collectively, they are a force to be reckoned with.

Affairs for WellMed Medical Management in Florida, a

2. Without them and the care they provide, their loved ones (also your patients) would, for all practical purposes, have a much depreciated quality of life.

UnitedHealthcare company.

3. By virtue of being a family caregiver, they are showing others that age and illness are part of life and as such require compassion, kindness and respect.

4. They make delicious lemonade out of life’s lemons!

5. And with an attitude of “taking your oxygen first” this could also be a special time of awareness, transformation and selflove in your life as well.

care reform. Dr. Jamie blogs for Psychology Today and sat on the NASW committee to establish national protocols for certification and standardization of caregiving practices. He writes for Florida MD and Today’s Caregiver Foundation and created the signature programming for its psychosocial drop-in model, Leeza’s Place, opening 8 national locations, each with a different funding partner, in Your Oxygen First: Protecting Your Health and Happiness While Caring for a Loved One with Memory Loss, with as Vice President of Provider Relations and Government 

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6. They are your greatest supporters!

FLORIDA MD - NOVEMBER 2014

3

COVER STORY

Consulate Health Care­— Improving

Care through an Enhanced Patient Experience

By Ann Alexander Consulate Health Care, a national leader in post-acute care, is forging the way to improved patient outcomes and interdisciplinary collaboration. As the sixth largest provider in the U.S., and the largest in the State of Florida, that is no small feat.

Joseph D. Conte, president and chief executive officer, originally founded Tandem Health Care in 1997, with one center in Cheswick, PA. Under Conte’s leadership in 2006, Tandem grew into Consulate Health Care with seventy-eight centers in six states. Today, Consulate encompasses more than two hundred centers in twenty-one states, offering services ranging from comprehensive post-acute care and rehabilitation (including physical, occupational and speech/language therapies) to long-term skilled nursing, Alzheimer’s and dementia care.

Meeting the needs of patients and residents is a top priority.

Whether they are long-terms residents or short-term patients recovering from surgery and planning to return home, Consulate is staffed by a professional team of registered nurses (RNs), licensed practical nurses (LPNs), certified nursing assistants (CNAs) and rehabilitation therapists; team members also vital to patient care include social services, food services, housekeeping, engineering, admissions and administrative support staff. Each care center also has a Medical Director and attending physicians of the patients’ choice.

Short-term care and rehabilitation Consulate Health Care offers services for patients recovering

from surgery or illness who no longer require a hospital stay -- but who aren’t quite strong enough to return home safely and independently. Rehabilitation programs provided in-house at each center help patients rebuild the strength and mobility they need in order to return home. Licensed therapists provide physical, occupational and speech / language therapy for a wide range of illnesses and injuries (such as orthopedic surgery, stroke or heart disease).

• Physical therapy promotes mobility and functional ability, with the goal of assisting patients in returning to their highest level of functioning. Each patient is evaluated on admission and a personalized treatment plan is developed. Physical therapy may include exercise, gait training, range of motion therapy, balance, falls prevention and pain management.

• Occupational therapy helps patients return to the activities of daily living; that is, the skills necessary for independent living. In occupational therapy, patients are not only assessed for their abilities, their normal environments are also evaluated in case modifications are necessary. Patients practice everyday skills such as dressing, bathing and eating; they also participate in memory, coordination and balance activities.

• Speech and language therapy assists patients with written and verbal communication or swallowing. (Modalities such as the VitalStim are used to improve swallowing skills). Speech therapists also help patients with memory, reasoning skills and oral muscle strength.

Consulate Health Care began as a small provider in Florida with a strong focus on patient needs.

Consulate has grown to become the sixth-largest provider of senior healthcare services in the nation and the largest in the State of Florida. Operating more than 200 centers in 21 states, we offer services ranging from comprehensive short-term transitional care to Alzheimer’s and dementia care.

Long-term, skilled nursing care Skilled nursing care is provided around the clock, and specialty services are tailored to meet the needs of each patient: • Cardiac, pulmonary and poststroke care

Photo: PROVIDED BY CONSULATE HEALTH CARE

• Oncology care • Wound care • Palliative care • Tracheostomy care • Pain management • Orthopedic care • Nutritional services - when special diets are prescribed (such as low-sodium, low-fat or liquid) 4 FLORIDA MD - NOVEMBER 2014

Photo: PROVIDED BY CONSULATE HEALTH CARE

COVER STORY

As Ambassadors of Care, we are committed to “Providing Service with Our Hearts and Hands”. Our success in achieving our Mission requires that our core values of Compassion, Honesty, Integrity, Respect and Passion are applied every day, not only to our residents and families, but just as importantly to one another and the communities we serve.

Many Consulate centers also offer Alzheimer’s and dementia / memory care programs. These focus not only on patients, but also on their family members. Alzheimer’s can be an overwhelming disease with both physical and emotional struggles for all involved. Consulate’s goal is to preserve the dignity of each resident, and with family participation, care plans are developed that address comfort, abilities and activities of daily living. Care is provided by specially trained team members who assist with everyday basics such as personal hygiene, showering and bathing, assistance with eating, continence management and mobility.

Respite care is also available for families caring for loved ones at home. Consulate accepts patients on a temporary basis so that families and caregivers may experience some relief and rest.

Consulate also works with various hospice organizations for medical, emotional and spiritual support for patients in the last stages of a terminal illness.

For residents who do not require specialized care, Consulate also features comfortable and secure assisted and independent living locations, as either apartments or single family homes. Amenities include landscaped grounds, housekeeping services and transportation.

Serving the needs of the community To achieve quality patient care, safety and satisfaction across the board, Conte and his senior management team recognize three fundamental ingredients: engaged employees, cutting-edge technology and multi-disciplinary collaboration. “To enhance our mission of ‘providing service with our hearts and hands’, we have implemented new employee programs and invested in our infrastructure,” he explains.

Care and collaboration start with employee engagement Employee engagement can be challenging, admits Conte, especially on such a large scale and with recent corporate mergers and acquisitions. New employees from these mergers take time to engage and build a loyalty to their new company. “We are a large family,” he says, “and we want our caregivers to treat our patients and residents like family. I know that the best care is delivered when team members are engaged with each other and the company.”

Chief Administrative Officer Veronique Keller agrees. “Each person on the team, even those who provide indirect care, need to understand their unique role and how we all connect,” she says.

“Patients benefit most when we are all engaged in their plan of care. Together we truly make a difference.”

How do you engage a workforce in over 200 facilities?

According to Conte, the first valuable step is recognition. “We recognize our employees when they demonstrate our core values– compassion, honesty, respect, integrity and passion,” he explains, “and that begins with education.” For the past 2 years, Consulate has offered more focused educational programs to employees that promote positive working relationships and better communication between departments. As a result, subsequent employee surveys have reported gains in employee engagement levels.

Emerging technology promotes seamless, secure communication Consulate is also on the cutting edge of improved clinical coFLORIDA MD - NOVEMBER 2014

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Photo: PROVIDED BY CONSULATE HEALTH CARE

COVER STORY

As a leader in short-term rehabilitative services, Consulate strives to get people home faster through their comprehensive short-term transitional care services and physical, occupational and speech therapies.

ordination and communication tools. According to Chief Information Officer Mark Crandall, Consulate’s chief objective is to provide physicians, nurses and therapists with easily accessible and secure patient information. Advancing technology is making that goal a reality.

“We are using technology to furnish patient data right at the bedside, right at your fingertips,” Crandall says. “We have invested in the infrastructure necessary to provide a highly efficient electronic health record (EHR) platform, and we are preparing to employ telehealth and point of care devices in our care centers.”

Supporting an eco-friendly “paper light” environment, Consulate’s EHR promotes seamless and accessible communication among caregivers -- from the patient’s original physician encounter through the hospital admission and skilled nursing stay -- and beyond. The telehealth system allows remote practitioners to assess and observe patients through a live video feed. Peripherals, such as blood pressure readings, as well as the EHR, are real-time and can be read concurrently.

“With thousands of caregivers employed by Consulate and an extended network of physicians, our utmost concern is granting secure access to authenticated devices at the patient’s bedside,” reports Crandall. In addition to the computers on wheels (COWs), physicians and nurse practitioners will soon have the ability to utilize their approved mobile devices (iPhones, iPads, Android tablets, etc.) at the patient’s bedside. “We are working internally and with our chosen software partners to ensure that we can quickly and securely on-board the wireless devices that deliver actionable data and electronic health records right to where the data is needed to give the best care possible at the bedside,” Crandall says. “We must have an easy workflow that is user-friendly and secure.”

With these innovations, automating data collection and analy6 FLORIDA MD - NOVEMBER 2014

sis, physicians and nurses are saving time and have the ability to provide more hands-on care. The innovative technology and advanced communication tools improve efficiency, accuracy and safety – and, most importantly, patient care.

“We can do so much more at the bedside now than we could ten years ago,” affirms Crandall. “There will be no more searching for charts, no more deciphering numbers and letters. Everything is in one place, right at the bedside. Our caregivers can better focus on quality patient encounters, and that truly reflects our mission.”

ENHANCING PATIENT-CENTERED CARE THROUGH INCREASED PATIENT-PROVIDER RELATIONSHIPS As Chief Administrative Officer, Veronique Keller guides Consulate through the dynamic health care environment following the enactment of the Affordable Care Act (ACA) and ensuing payments and delivery systems reforms aimed at reducing the growth of health care costs. Consistent communication and interdisciplinary collaboration are essential. “The more we collaborate with each other – and the more we communicate with our residents and families – the better the outcome. The Affordable Care Act is encouraging us to break down our traditional silos,” says Keller, who is also a trained physical therapist.

New programs now implemented at Consulate illustrate their commitment to “breaking down the silos” and enhancing the patient-centered experience. The Journey Home program is a patient-centered planning initiative that is initiated at the time of admission. Patients complete a rehabilitation history describing prior levels of function, and they provide feedback about their home setting, loved ones and rehabilitation goals. Family members are encouraged to be as involved as possible. When return-

COVER STORY PHYSICIAN-PROVIDER RELATIONSHIP AND ENHANCED PATIENT EXPERIENCE According to Keller, programs such as “Journey Home” and care plan meetings encourage interdisciplinary collaboration and improve patient experience which is associated with improved health outcomes.

“We want to have a true interdisciplinary team, and we welcome our physicians to lead that charge,” she says. “Consulate is like the glue between the physicians, hospitals and home health.

We encourage our physicians to be active and involved in helping us excel with our patient care programs.”

Consulate Health Care receives prestigious awards Conte’s efforts are to have the Consulate team committed to engagement and excellence -- this is evidenced by dedicated employee ambassadors, technology and infrastructure advancements and patient-centric programs and collaborative efforts. As recognition for these innovative initiatives, Consulate Health Care recently received two distinguished awards.

Earlier this year, the American Health Care Association and National Center for Assisted Living (AHCA / NCAL) recognized fifteen Consulate Health Care centers as recipients of the Bronze Commitment to Quality Award. This national award, bestowed through the National Quality Award program, honors facilities for their commitment to quality care for their residents, and seniors and individuals with disabilities.

In September 2014, for a second consecutive year, the Orlando Business Journal ranked Consulate Health Care #1 in the Golden 100 Top 10 Privately-held Companies. Consulate was

Photo: PROVIDED BY CONSULATE HEALTH CARE

ing home to independent living is no longer a possibility, long term options at Consulate are discussed.

Another role that is being introduced is that of customer service liaison, who greets every new resident, delivers a welcome gift, and invites each resident and their loved ones to a care management meeting. This meeting involves a multi-disciplinary team composed of the attending physician, clinical services, case management, rehabilitation, pharmacy and the facility’s executive director. Physical / emotional needs and expectations are reviewed, and the care plan process is discussed – including prescribed durable medical equipment (DME) and medications, follow-up appointments, home health and community service needs.

Patient education is also crucial, particularly for patients with chronic disease. Brochures explaining disease management protocols -- for illnesses such as congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) and diabetes -- are distributed. Compliance is encouraged, with an emphasis on hospital readmission prevention.

Preventing falls is another important component to each patient’s care plan. Patients are reminded to ask for help if assistance is needed for getting in / out of bed; using assistive devices (such as a walker or wheelchair), toileting or navigating the hallways.

The Consulate care team meets regularly to assess environmental hazards or staff training needed to enhance the safety of residents and employees alike.

A new program under development is the “Nurse Navigator.” A nurse navigator will go to the patient’s home to encourage medication and disease management compliance. The nurse navigator will place follow-up phone calls and assist in scheduling subsequent physician appointments, among other services.

FLORIDA MD - NOVEMBER 2014

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COVER STORY recognized for successfully merging organizations “culturally, operationally and financially.”

Prescription for success

Photo: SHUTTERSTOCK

Since 2006, Consulate Health Care has been a national leader among skilled nursing centers for the highest standards in patient care and innovation. “We are the home-away-from-home for our residents,” concludes Keller. “In today’s changing health care environment, we believe that, more than ever, enhancing the patient experience will lead to better health outcomes for those entrusted to our care.”

That is the prescription for success. 

Better outcomes mean everything - Consulate understands that getting home and staying out of the hospital means spending more time with loved ones when it matters most. By employing compassionate caregivers and the best forms of technology, we are able to offer short-term programs that lead to quicker recovery.

CONSULATE HEALTH CARE • 800 Concourse Parkway S. • Suite 200 Maitland, FL 32751 • (407) 571-1550 • www.consulatehealthcare.com 8 FLORIDA MD - NOVEMBER 2014

PULMONARY AND SLEEP DISORDERS

InspireÂŽ Upper Airway Stimulation (UAS) Therapy for Obstructive Sleep Apnea

By Daniel T. Layish, MD and Jeffrey Phillips, MD Obstructive sleep apnea (OSA) is a very prevalent condition. It control. In addition, the therapy withDaniel T. Layish, MD has been estimated to occur in up to 4% of middle-aged men and drawal effect was tested in a random2% of middle-aged women. It is also associated with increased ized study after participants completrisk for cardiovascular morbidity/mortality. CPAP/BiPAP theraed 12 months of follow-up. One week py is effective in treating OSA, but tolerance of and compliance therapy withdrawal led to a return of with CPAP/BiPAP therapy is incomplete. Therefore, alternative OSA severity similar to baseline level therapies are needed for many patients with OSA. One such without therapy. therapy is InspireÂŽ, which was recently approved by the FDA to The study also demonstrated imtreat OSA. This involves placement of a small implanted system, provement in subjective measurewhich delivers mild stimulation to airway muscles to keep the airments of the severity of OSA, such way patent during sleep. Using a small handheld remote control, as daytime sleepiness. Subjects were the patient turns the therapy on before bed and turns the therapy excluded if their BMI was above 32 off upon awakening. InspireÂŽ therapy includes a stimulation elecor if they had neuromuscular disease, Jeffrey Phillips, MD trode which is placed on the hypoglossal nerve to recruit tongue intrinsic lung disease, pulmonary hyprotrusion function. There is also a sensing lead, which is placed pertension, valvular heart disease, congestive heart failure, rebetween the internal and external intercostal muscles to detect cent myocardial infarction, severe cardiac arrhythmias within six ventilatory effort. The neurostimulator unit is implanted in the months, if they had active psychiatric disease or persistent unconright mid infraclavicular region. Once implanted, settings are optrolled hypertension. timized by a sleep study (polysomnography) about 4 weeks post operatively.

This therapy was studied in the STAR trial (stimulation therapy for apnea reduction). The study was published in the New England Journal of Medicine in January of HEALTHCARE REALTY & DEVELOPMENT SERVICES (HRDS) JT ZPVS TJOHMF 2014. This study was conducted in 22 cenTPVSDF GPS IFBMUIDBSF GBDJMJUZ CSPLFSBHF DPOTVMUJOH DPOTUSVDUJPO BOE EFWFMPQNFOU ters across the United States and Europe and TFSWJDFT 8F QSPWJEF OBUJPOBM FYQFSUJTF PO B MPDBM TDBMF was a 12-month study. The first author was Dr. Patrick Strollo from the University of 8F TQFDJBMJ[F JO NFEJDBM PÄ&#x160;DF CVJMEJOHT BTTJTUFE MJWJOH GBDJMJUJFT TLJMMFE OVSTJOH Pittsburg Medical Center. The patients were DFOUFST CFIBWJPSBM IFBMUI SFTJEFOUJBM USFBUNFOU EJBHOPTUJD BOE TVSHFSZ DFOUFST BOE predominantly men (83%), there were 126 PUIFS SFMBUFE IFBMUIDBSF GBDJMJUJFT participants with a mean age of 54.5 years.

HEALTHCARE DEVELOPMENT SERVICES BROKERAGE SERVICES The mean body mass index (BMI) was 28.4, t 1FSNJUUJOH t 4JUF "OBMZTJT which is certainly lower than the typical BMI t "SDIJUFDUVSBM %FTJHO t 4USBUFHJD 1MBOOJOH seen in patients with OSA. The patients in t 7BMVF &OHJOFFSJOH t 1SPQFSUZ 4JUF "DRVJTJUJPO the study either had previous difficulty accepting or adhering to CPAP therapy. The t 1SPQFSUZ &WBMVBUJPO t 4FMMJOH BOE %JTQPTJUJPO mean apnea hypopnea index (AHI) det 3FGVSCJTINFOU t 5FOBOU SFQSFTFOUBUJPO creased by 68% after 12 months of InspireÂŽ t 5FOBOU *NQSPWFNFOUT t 1SPQFSUZ NBOBHFNFOU therapy, from an average of 29.3 before thert /FX $POTUSVDUJPO t #VTJOFTT CSPLFSBHF apy to an average of 9.0 events per hour after For more information contact: therapy. The oxygen desaturation index score decreased by 70% (from 25.4 desaturation events per hour down to 7.4 desaturation events per hour). The rate of procedure related serious adverse events was less than 2%.

Mjdfotfe!Sfbm!Ftubuf!Csplfst!0!Mjdfotfe!Cvjmejoh!Dpousbdupst!!ÂŚ!Qipof;!518.:58.6185 The primary outcome was based on a cohort IfbmuidbsfSfbmuzTfswjdftAHnbjm/dpn!!0!!IfbmuidbsfSfbmuzPomjof/dpn study with participants serving as their own

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FLORIDA MD - NOVEMBER 2014

9

PULMONARY AND SLEEP DISORDERS

17% of the patients in the STAR study had undergone previous uvulopalatopharyngoplasty. BMI did not change on average over the 12 months of the study. The median time for surgical implantation was 140 minutes (range 65-360 minutes). The vast majority of the patients were discharged from the hospital within 24 hours of surgery. Two of the participants in the study had to have repositioning and fixation of the neurostimulator to relieve discomfort. Most of the adverse events occurred within 30 days after implantation and included sore throat from intubation, pain at the incision site and muscle soreness. 40% of participants in the study reported some discomfort associated with stimulation. The stimulation of the hypoglossal nerve is unilateral and synchronous with ventilation. The recommendation is to screen potential participants through a drug induced sleep endoscopy procedure to help identify upper airway collapse that was likely to be focused on the retrolingual region and would therefore be amenable to forward motion of the base of the tongue by means of neurostimulation. If there is complete concentric collapse at the palate with sleep endoscopy then the patient would not be a candidate for the procedure. Patients who have more than 25% Central apneas are not felt to be candidates for Inspire® therapy at this time. The recommended age for Inspire® is 22 and above.

Compliance with the upper airway stimulation system was excellent at 86% daily use. The device was used for an average of more than five hours per night. It is worth noting that some participants (15%) had an increase in their AHI after 12 months, this was down to 7% at 18 months post-op. The STAR authors did an analysis but could not identify predictors to differentiate between those patients who responded versus non-responders.

Based on the data from the STAR trial, the FDA approved Inspire® therapy. This therapy is only approved for a subset of patients with moderate to severe OSA (AHI 20-65/hour) who have less than 25 percent central apneas. Also, there must not be evidence of complete concentric collapse of the palate identified by a pre-op drug induced sleep endoscopy. BMI should not be above 32, so this therapy will not be appropriate for OSA patients with morbid obesity. CPAP/BiPap therapy should be offered before Inspire®, and only those patients unable to use CPAP/BiPap 10 FLORIDA MD - NOVEMBER 2014

should undergo this surgical procedure. Snoring improved in 85 percent of patients, but Inspire is NOT intended as a primary treatment for snoring. Patients who have undergone this procedure will be unable to undergo MRI imaging. The STAR trial shows that with this careful patient selection Inspire® therapy (on average) reduces AHI significantly and improves daytime sleepiness with good compliance and an acceptable safety profile. This provides an important alternative therapy for patients with moderate-to-severe OSA who are unable to tolerate CPAP therapy.

Daniel Layish, MD, graduated magna cum laude from Boston University Medical School in 1990. He then completed an Internal Medicine Residency at Barnes Hospital (Washington University) in St.Louis, Missouri and a Pulmonary/Critical Care/Sleep Medicine Fellowship at Duke University in Durham, North Carolina. Since 1997, he has been a member of the Central Florida Pulmonary Group in Orlando. He serves as Co-director of the Adult Cystic Fibrosis Program in Orlando. Dr. Layish may be contacted at 407-841-1100 or by visiting www.cfpulmonary.com.

Jeffrey Phillips, MD graduated from the University of Wisconsin School of Medicine and Public Health. He completed his residency training in Otolaryngology-Head & Neck Surgery at Louisiana State University Health Sciences Center in Shreveport, LA (LSUHSC) and is board certified in all aspects of otolaryngology and head and neck surgery. Dr. Phillips has recently completed a fellowship in surgical and medical treatment of sleep disorders at the Medical College of Wisconsin in Milwaukee, Wisconsin before joining the Ear, Nose, Throat and Plastic Surgery Associates in Orlando, Florida. His interests include both medical and surgical treatment of sleep apnea, sinonasal disorders, head & neck surgery, endocrine surgery and all aspects of general otolaryngology. For further information or consultation, please call 407-644-4883 or visit www. entorlando.com. 

Healthcare Law

Health Law E-lert -- Health Care Providers and their Attorneys can have Direct Access to Patients’ Protected Health Information in Malpractice Cases

By Benjamin W. Newman A recent case from the U.S. Court of Appeals for the Eleventh Circuit has decided that a Florida law allowing prospective defendants in medical malpractice cases to obtain records directly from other health care providers and to interview them about patient care and treatment is fully compliant with the Health Insurance Portability and Accountability Act (HIPAA), under certain conditions.

On October 10, 2014, the court in Murphy v. Dulay, Case No. 2013-14637, issued an opinion holding that a prior ruling from the U.S. District Court for the Northern District of Florida was incorrect. Specifically, the appellate court found that Florida Statute Section 766.1065 is fully compliant with the HIPAA statute and its regulations, and accordingly, reversed the prior order of injunction against enforcement of the statute.

The statute in question took effect on July 1, 2013, however it was immediately challenged in federal court. The statute required that prospective plaintiffs who intend to file a malpractice claim must provide an “Authorization for Release of Protected Health Information” to any health care provider they intended to sue, in addition to other statutory requirements. The Authorization is to provide access to medical records and to allow interviews of those health care providers who have knowledge relevant to the alleged injuries in the potential malpractice case. Previously, prospective defendants in malpractice cases could only obtain records through the prospective plaintiff’s attorney and could only interview other health care providers in the presence of that attorney during the presuit investigation. Once a claim became a lawsuit, defendants and their attorneys could only obtain the patient’s records by subpoena and were expressly prohibited from communicating with health care providers directly and could only do so by taking depositions of them. With the court finding the new law is valid, malpractice defendants and their attorneys can now have direct contact with certain health care providers during both the presuit investigation and during litigation.

The Eleventh Circuit reasoned that the Florida statute does not conflict with HIPAA in regard to preserving Protected Health Information, for several reasons, including that the authorization was voluntary, that it was only valid through the course of litigation, that it could be revoked at any time by the patient, and that it only authorizes access to records and health care providers who have information relevant to the claim.

By upholding Section 766.1065, the court has validated the legal right of health care providers, their insurance providers and

attorneys, to access protected health information in a more expeditious and efficient manner and to give additional methods to obtain and analyze relevant information in medical malpractice claims.

Health care providers and their legal counsel should develop a strategy on how to utilize these additional discovery methods with an eye toward remaining in compliance with this new law.

Careful consideration must be given towards objections plaintiff’s counsel may raise to limit or prevent the greater latitude malpractice defendants have been given by this statute, especially as it is anticipated there will be additional legal challenges to its validity and scope.

Benjamin W. Newman is a shareholder in GrayRobinson’s Orlando office in the Litigation Practice Group. He concentrates his practice in insurance defense, medical malpractice defense and mediation/arbitration services.

Ben represents medical and podiatric physicians, hospitals, home health nursing agencies, chiropractors and emergency medical services. Ben can be reached at 407-843-8880 or ben.newman@gray-robinson.com. 

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CANCER

Dendritic Cell Vaccines for Glioblastoma

By Arnold Etame, MD, PhD Editorâ&#x20AC;&#x2122;s Note: This article originally appeared in the July 2014 issue of OncLive Magazine.

Glioblastoma (GBM) is a very lethal tumor and represents the most common primary brain tumor in adults1. The current multimodal therapy of surgery, chemotherapy and radiotherapy is often ineffective. Consequently, higher rates of tumor recurrence and progression are often the rule as opposed to the exception with GBM, and the prognosis is very dismal. Patients expectedly have a median survival of less than 15 months2. Furthermore, by the 5th year of diagnosis, over 90% of patients would have succumbed to the disease3. Novel and effective alternative therapeutic strategies are therefore highly desired.

Immunotherapy is rapidly emerging as a very attractive and novel therapeutic approach for cancer. Cancer-specific immune responses can occur through several non-mutually exclusive strategies which include activation of the immune system with tumor antigens; neutralization of tumor antigens with antibodies; enhancement of immune-stimulatory signaling pathways that are promote cytotoxic T cell activity; or adoptive T cell tumortargeting mechanisms.

Two pivotal landmark studies resulted in FDA approval of immunotherapy-based treatment for malignant melanoma4 and castration-resistant prostate cancer5. Hodi and colleagues, demonstrated a significant improvement in overall survival(OS) in metastatic melanoma patients treated with ipilimumab, a monoclonal antibody directed against cytotoxic T-lymphocyte antigen 4 (CTLA4)4. By releasing CTLA4 inhibition of cytotoxic T lymphocytes (CTLs), CTLs easily recognized and destroyed melanoma cells. In parallel, Kantoff and colleagues demonstrated a significant improvement in OS for patients with castrationresistant prostate cancer who were treated with a dendritic cell vaccine called sipuleucel-T5. The above studies concretized the role and integration of immunotherapy in the standard of care of select cancers, thereby setting the foundations and enthusiasm for applicability to other cancers.

Most immune-based therapeutic strategies for GBM have focused on the concept of vaccines. The overwhelming majority of GBM vaccine applications have been based on dendritic cells (DCs). DCs are particularly attractive in vaccine applications in light of their exquisite efficient ability to present foreign antigens as antigen presenting cells (APCs) to the immune system thereby generating an antigen-specific adaptive immune response. With this approach, expanded clones of autologous DCs pulsed with either GBM cell lysates or tumor-derived peptides are used for the vaccine (Figure 1). It is anticipated that the DCs will recognize GBM cells bearing applicable antigens leading destruction of residual GBM tumor cells through adaptive immune-mediated mechanisms. A major feature of this approach is its personalized cancer care focus, and the potential to target abroad range of tumor antigens. Potential limitations of this strategy include the requirement for surgical resection, as well as the labor-intensive 12 FLORIDA MD - NOVEMBER 2014

and complex process of vaccine manufacturing.

The safety, immunogenic potential, and effectiveness of DC vaccines pulsed with GBM tumor cell-lysates or tumor-eluted peptides have been well established in preclinical6-11 as well as clinical studies12-22. The preponderance of evidence suggests that the vaccine strategy is well tolerated, effective, and can improve overall survival in a tumor-specific immune-response dependent fashion. One of the largest clinical series of DC vaccines was by De Vleeschouwer and colleagues18. They safely treated 56 recurrent GBM patients with DCs pulsed with autologous tumor lysate as post-surgical adjuvant therapy. There was a marked tendency towards improvement in both progression free survival (PFS) and overall survival (OS) within the vaccination group. Currently, our center is participating in a multicenter Phase 3 randomized double-blinded clinical trial examining the efficacy of a DC vaccine, DCVax, derived from autologous dendritic cells pulsed with GBM lysates in newly diagnosed GBM. One of the critical lessons from initial clinical trial efforts with DC vaccines was correlating therapeutics benefits with immunogenicity. The first attempt to establish vaccine efficacy with immunogenicity on the DC platform was in the clinical trial by Wheeler and colleagues19. When they treated 32 patients with GBM using DCs pulsed with GBM lysate, they clearly identified T-cell responsiveness as a variable that strongly correlated with a prolonged survival and prolonged disease progression time in the vaccinated cohort. Subsequent clinical studies have similarly assessed and confirmed correlation between immunogenicity and therapeutic benefit for such patients. Markers of immune- responsiveness could facilitate optimal stratification of patients in the future.

Synthetic peptides derived from tumor-associated antigens have been employed as well in DC vaccines. The ease of manufacture in substantial amounts makes this approach attractive. For GBMs in particular, the mutated epidermal growth factor receptor variant III (EGFRvIII) is a highly immunogenic target with surface expression in 30-40% of GBM23. In preclinical orthotopic GBM models, a synthetic peptide derived from a segment of EGFRvIII demonstrated immunogenicity, significant antitumor activity, inhibition of formation of tumor in 70 percent of vaccinated animals, and ultimately resulted in long-term survivors24.

In a subsequent clinical study of newly diagnosed GBMs, the same group was able to demonstrate EGFRvIII-specific immune responses secondary to vaccination using DCs pulsed with the synthetic peptide derived from a segment of EGFRvIII25. Median PFS of 6.8 months and median OS of 18.7 months relative to onset of vaccination were realized representing a significant improvement compared to match controls. Several additional clinical trials are underway examining EGFRvIII as a vaccine target.

CANCER In order to broaden the antigen coverage of DC vaccines, another approach has been to pulse DCs simultaneously with a panel of several tumor-associated antigen peptide. Using DCs directed against a panel of 6 glioma-associated antigen peptides, Phuphanich and colleagues demonstrated an overall median survival of 38.4 months in newly diagnosed GBM who expressed at least 3 of the 6 antigens in a Phase 1 clinical trial26. Within the series of 15 patients, 5 patients demonstrated post-vaccination T-cell responsiveness as evidenced

by CD8+ and interferon-gamma production. Based on these encouraging findings, placebo-controlled, randomized Phase 3 studies using this 6-peptide panel are underway.

Moreover, the strategy of employing DCs to target tumors antigens can be extrapolated to targeting cancer stem cells that serve as the ultimate drivers of therapeutic resistance and tumor propagation. There is preclinical evidence that DC vaccines can target the tumor stem cell resistant clones if pulsed with stem cell specific antigens27, 28. In a recent clinical study involving 7 GBM patients treated with DC pulsed with mRNA from cancer stem cells, the investigators demonstrated the safety, feasibility as well as the potential for such an approach to positively influence PFS 29. Additional studies are warranted for further validation of this approach.

In summary, DC vaccine strategies have demonstrable clinical feasibility, safety and efficacy in a subset of GBM patients. Efforts at identifying humoral factors that correlate with vaccine efficacy as well as strategies that enhance T-cell responsiveness secondary to vaccination could have a significant impact. The theoretical risk of unintended autoimmune reactions to this vaccine strategy remains extremely low. Several clinical trials are underway looking at whole tumor cell lysates, tumor-eluted peptides, as well as synthetic tumor associated peptides and nucleic acids with exciting prospects. Our center is involved with some of these endeavors notably the whole cell lysate approach for newly-diagnosed GBM in a Phase 3 clinical trial format. References available upon request.

Arnold Etame, MD, PhD is a neurological surgeon and scientist specializing in Neuro-Oncology at the Moffitt Cancer Center and assistant professor of oncology at the University of South Florida College of Medicine. He performs a substantial number of surgeries in eloquent and non-eloquent regions of the brain with image-guided stereotactic techniques entailing functional MRI and DTI tractography neuro-navigation. Dr. Etame also directs a very active awake-brain tumor resection program for patients with tumors close to critical areas for speech and movement. His research focuses on enhanced delivery of targeted therapeutics across the blood-brain barrier for malignant and metastatic brain tumors using nanotechnology and focused ultrasound disruption of the blood-brain barrier. He is a principal investigator for clinical trial protocols in patients with malignant brain 800-382-2610 tumors. 

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FLORIDA MD - NOVEMBER 2014 13

Financial Update: Insurance • Benefits • Wealth Management

Rules Governing Inherited IRAs Change in 2014

By S. Kyle Taylor

The Bankruptcy Abuse Prevention and Consumer Protection Act of 2005 created an exemption from creditors for Individual Retirement Accounts (IRAs). The exemption was capped at $1 million in 2005 and has grown to $1,245,475 due to cost-ofliving increases. Over the last 9 years, federal court decisions have been split over whether or not inherited IRAs should be protected under the act.

The United States Supreme Court ruled on June 12, 2014 that “inherited IRAs” are not retirement funds and are not exempt from the IRA holder’s creditors. It has been determined that the funds are part of the estate and are subject to the claims of creditors. The Court identified three primary characteristics that keep the funds in inherited IRAs from being considered “Retirement Funds.”

1. Owners of inherited IRAs are required to withdraw money from the accounts, regardless of their ages.

2. Owners of inherited IRAs may not contribute additional money to the account.

3. Owners of inherited IRAs may withdraw the entire balance of the account at any time, and for any purpose without penalty.

The Court concluded that an inherited IRA constitutes “a pot of money that can be freely used for current consumption rather than funds set aside for one’s retirement.” Since the individual owner of an inherited IRA can access the funds without penalty and for any reason, the Court concluded that those assets will be subject to the claims of creditors.

It is very important to remember that care must be taken to maintain appropriate beneficiary designations for all IRA, 401k or qualified accounts especially if creditor protection for your heirs is important. One option is to consider naming a trust as the beneficiary on your accounts, however be sure to consult a qualified professional as there may be significant legal and tax implications to establishing a trust as the beneficiary to your IRA. The laws and rules for managing your estate are constantly changing, that is why we recommend periodic reviews and consultations with your tax professional or an estate planning attorney.

Kyle Taylor offers Securities and Investment Advisory Services through NFP Advisor Services, LLC (NFPAS), Member FINRA/ SIPC. NFPAS is not affiliated with The Vaughn Group. NFPAS 14 FLORIDA MD - NOVEMBER 2014

does not provide tax or legal advice.

Securities and Investment Advisory Services offered through NFP Securities, Inc., Member FINRA/SIPC. NFP Securities Inc. is not affiliated with the Vaughn Group, Inc. NFP Securities, Inc. does not provide tax or legal advice.

S. Kyle Taylor is a principal at The Vaughn Group, Inc. and manages the wealth management department. As an independent financial advisor, he focuses on helping his clients understand the importantce of developing a strategic, long-term wealth plan.

Kyle believes that wealth management is a process and a partnership built on trust and integrity. He approaches that process by gaining clarity about a client’s current situation – identifying core values, defining future goals, and developing a flexible strategy that allows them to reach their objectives.

Kyle graduated from the University of Florida with a B.A. in Finance and also attended the College for Financial Planning. He can be reached via email at kyle@ vaughngroup.com or by phone at (407) 872-3888. The Vaughn Group, Inc.’s offices are located at 1407 E. Robinson St., Orlando, FL 32801. 

Be sure and check out our website at www.floridamd.com!

Coming UP Next Month: The cover story focuses on Compass Research, a clinical research company dedicated to testing investigational medications that cover a broad range of diseases and disorders.

Editorial focus is on Pain Management and Occupational Therapy.

ORTHOPAEDIC UPDATE

Local Mom Experiencing Life Again Without Pain Thanks to Cervical Disc Arthroplasty

By Corey Gehrold As a server working three jobs and raising three kids, you could say Patti, a southwest Orlando resident, has her hands full. So when her herniated disc in her neck became so bad she couldn’t lift her left arm and certain movements resulted in extreme neck pain, she decided it was time to do something to regain her quality of life and her ability to work and provide for her family.

for the vertebrae. “These artificial discs function much like a joint, and allow for extension, flexion and bending of Stephen R. Goll, MD the cervical spine,” says Dr. Goll.

“The intervertebral discs are critical to maintaining normal mobility and function of the neck.” Dr. Goll goes on to say when these discs are healthy they serve as cushions for the individual bones of the neck. When damaged, compressed or herniated as a result of trauma or degenerative disc disease, the vertebrae rub together and create extreme discomfort, nerve compression, weakness, numbness, loss of coordination, muscle spasms and, in some cases, the inability to function in normal day-to-day activities.

How is a Cervical Disc Arthroplasty Performed?

Patti, a mother of three working three jobs, was able to return to work and all of her normal activities just two weeks after her cervical disc arthroplasty with Dr. Goll

She met with Stephen R. Goll, M.D., a fellowship trained spine surgeon at Orlando Orthopaedic Center, to discuss her symptoms and treatment options. Patti, already familiar with Dr. Goll from her successful lumbar disc surgery 13 years ago, was well aware of his stellar reputation and the fact he continually trains on the latest surgical techniques and minimally invasive treatment options for patients.

After working together to try all conservative treatment methods, Patti says she and Dr. Goll explored the pros and cons of a cervical disc arthroplasty, also known as a cervical disc replacement.

Once she weighed the options and had all of her questions answered by Dr. Goll, she made the decision to have the surgery and, today, she couldn’t be happier with the results.

“I have full motion in my neck, I was back to work in two weeks and I am completely back to doing everything I did before,” she says. “I have no pain, no numbness and I am doing wonderful!”

What is a Cervical Disc Arthroplasty?

A cervical disc arthroplasty is a surgical alternative to standard cervical fusion for treatment of a herniated disc in the neck for some patients. The procedure involves inserting an artificial disc replacement into the intervertebral space of the cervical spine to maintain motion and eliminate pain when a patient’s own herniated or damaged disc can no longer provide adequate support

Dr. Goll performs the cervical disc arthroplasty by making a small, one-inch incision on the anterior (front) of the neck, gently moving the soft tissue to gain access to the cervical spine.

Once the area is exposed, he will remove the damaged disc and any other fragments An MRI of a herniated disc at level C6-C7. or bone material putting pressure on the spinal cord or nerve roots. This is sometimes called discectomy or decompression.

After the damaged disc has been removed it will be replaced with the artificial disc, which is then secured in place. The soft tissues will be eased back into place and the incision will be closed.

What is the Recovery Process Like for a Cervical Disc Arthroplasty?

Dr. Goll and his patient care team develop a specific post-operative recovery plan to help patients get back to their lives as quickly and safely as possible. Patients are typically up and walking on the day of surgery.

In Patti’s case, she was able to return to work and all of her normal activities in just two weeks; however, return to work varies depending on how well a patient is healing and the type of activity level a patient plans to return to once recovered.

“When I woke up from surgery I felt really amazing actually,” says Patti. “My only regret is that I waited so long to have the procedure done.”  FLORIDA MD - NOVEMBER 2014 15

Marketing Your Practice

10 Tips to Making a Great Practice Brochure By Jennifer Thompson Do you want to know how to create agorgeous practice brochure that people actually want to pick up and read? As a general rule, people like pretty things. Newsflash – we know.

But appealing to this most basic human principle can help you attract and retain more patients immediately.

How, you ask? Put yourself in the shoes of a patient. You’re at a crowded, cramped community event and there’s a few medical offices there as part of their grassroots marketing efforts.

All of the booths look basically the same; so you grab a brochure from each as you walk around and try to find your child… who has run off either to the cotton candy guy at the end of the row or the bounce house at the complete opposite side of the event. Kids.

In this scenario the patient will, first, find their child – thank goodness. Then, when they get home, they might look through the pile of material they’ve collected and start throwing out the junk. You’ve got a split second to make a lasting impression on them.

They flip through both brochures, read about 8 words total, and keep the one that looks prettier. If that’s yours, odds are they’ll put it up on the fridge and remind themselves to make an appointment Monday. So, how can you ensure your brochure winds up on some prime fridge real estate?

Tips to making a great practice brochure Use big, happy photos. Always remember that you want to show the end result, not the pain in photos. Patients are experiencing discomfort; so all that matters is that they can get back to smiling and enjoying activities like riding a bike or sitting on the beach (like those pretty people in the photos) as soon as possible.

Keep the word count down. People do not want to read so don’t make them read more than they have to. Think of simple statements. Keep your services listed in bullet form and speak to the pros of coming to your office first and foremost. No one will read the rest and it makes your brochure look intimidating.

Use benefit-oriented headlines. When opening up the brochure for the first time, your patient will skim the headlines.

Make sure your headlines grab their attention and help them down the page and through the copy.

Headshots should be (somewhat) current. You can’t talk about all of your state-of-the-art, minimally invasive procedures and options right next to a headshot that was clearly circa 1987 (especially if your doctor has lost a few inches of hair since then).

Keep headshots current to at least 5-6 years.

Put your phone number and website everywhere. You want 16 FLORIDA MD - NOVEMBER 2014

this information to be easy to find no matter where the brochure is seen. Front cover (in case it makes it to the fridge), inside while reviewing the content and on the back while it’s flipped over.

Don’t overlook this easy opportunity to be found.

Be careful whom you list. Typically, physicians stick around for a long time in a practice. PA’s, office managers and coordinators? Not as much. If you’re going to list staff, keep it to the doctors so you don’t have to redesign brochures annually to keep up with the new faces.

Put your logo and relevant photo on the cover. Sounds like a no-brainer, right? You’d be surprised. As we mentioned in tip #4, also be sure to put your phone number and web address on the cover as well.

Keep the look consistent with your website. Keeping the same look is known as a brand image. You want the same brand image across all of your marketing material. So, if you redesign your brochure and love the look, make sure your website follows closely behind.

Use the right colors. Stick with colors that are often associated with medical practices like blue, green, white and light purple.

Stay away from reds, blacks and grays whenever possible.

Hire a good designer. “You get what you pay for” is especially true in the world of design. Do not try to do this in Microsoft Publisher in your spare time (hah) or use a staff member’s cousin.

To really make an impact and keep the same design for multiple years you’ll want to spend the extra few dollars and have it professionally done.

There you have it. Regardless of the size of your practice or your resources, the tips found above will assist you in creating a brochure that properly represents your practice, impresses potential patients and earns you a spot on their fridge… all for being pretty.

Looking for more ways to attract and retain more patients?

Check out DrMarketingTips.com for free articles, webinars, ebooks, audio blogs and more for your practice.

Jennifer Thompson is co-founder and chief strategist for DrMarketingTips.com, a website designed to help medical marketing professionals market their practice easier, faster and better. 

FOOT & ANKLE

A Pain-Free Answer for Toenail Fungus

By Biff Kramer, DPM

How many times have you tried to get rid of stubborn fungus nails? Do you find yourself saying, “I have tried everything and I can’t get rid of these ugly nails”? I can’t tell you the hundreds of times I have heard that statement throughout the past 45 years I have been in practice.

Until five years ago, there were next to no answers. In 2009 Orlando Foot and Ankle Clinics began using a revolutionary new technology to treat nail fungus. This new technology was a laser and the results were quite good. As the years pass, technology has enabled us to continue to upgrade, and we are now on our third laser device. Our latest laser, the Q-Clear, has a 95% success rate (as defined by the FDA), is FDA approved, and is painless.

The procedure is quick and easy. It takes about 20 minutes and there are no restrictions or limitations afterwards. As a matter of fact, some of my female patients go for a pedicure immediately after the treatment. There are no contraindications and no side effects.

We follow up with six month checkups until the new healthy nail is completely grown in, about 18 months to 2 years. Should a

second treatment be necessary, which is rarely the case, it is provided as part of the follow up.

In the five years that I have been using this technology, the results have been very gratifying, and as we have upgraded the results have improved. The Q-Clear gives us fantastic results with no discomfort and most importantly my patients love it. I believe the 95% success speaks for itself, but not as loudly as the smiles on my patients faces. The Q-Clear laser also works well removing superficial spider veins, and tattoos. We offer this treatment plan at five of our 17 locations in the Metro Orlando area.

Biff Kramer, DPM holds his podiatric degree from New York College of Podiatric Medicine. He has been in practice for over 45 years and treats patients suffering from toe nail fungus at five of Orlando Foot and Ankle Clinics 17 convenient locations. For more information on this revolutionary treatment please visit us at our website www.orlando-laser. com or call us at 407-423-1234 to make an appointment. 

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407.841.1100 phone | www.cfpulmonary.com | Most Insurance Plans Accepted FLORIDA MD - NOVEMBER 2014 17

7 Reasons Hospital-Physician Mergers Hurt Health Care

By Marni Jameson Every day more physicians are giving up their independent practices to become hospital employees.

And who can blame them? It’s tempting.

Hospitals can offer doctors more money, since hospitals get paid more for the same procedures. Plus, hospitals will take over the administration of the practice, and will cover staffing, billing, overhead and marketing. They will drive patient referrals into the practice, cover the costs of electronic medical records, and pick up the tab for the malpractice insurance. Why wouldn’t a doctor do this?

Well, because hospital-physician consolidations have many repercussions that doctors may not realize. Studies show that such mergers can negatively impact patients, doctors, communities and the nation’s health care.

Here, according to Tommy Thomas, a Winter Park CPA, and founder of the Association of Independent Doctors, are seven of those consequences, which physicians should consider before they trade independence for employment:

1. Competition decreases: When hospitals buy physician practices, competition dries up. It’s simple economics: Fewer independent providers competing with each other means costs go up and quality goes down.

According to America’s Health Insurance Plans, “An acquisition that eliminates significant competition between providers increases the ability of providers to lower their quality of care, abandon innovation, and demand and obtain higher prices for medical care.”

2. Quality goes down: Hospitals track how many patients their doctors admit and how many tests they order. Employed physicians’ employment contracts can depend on their numbers.

This pressure results in employed physicians ordering more unnecessary tests and procedures, which not only drives up health-care costs, but also can put patients in harm’s way.

“Consolidation of providers results in a well-documented record of harm to consumers with price increases of 20 percent to 40 percent after consolidation,” according to AHIP. 3. Patients have less choice: Employed physicians are expected to refer to other doctors employed by that hospital, and to order tests through hospital-owned facilities, regardless of whether those doctors or facilities are the best, or most cost effective.

Patients unwittingly get into the funnel going only to hospital-owned entities, which costs them more.

4. Costs increase. In a large study, the Medicare Payment Advisory Commission confirmed that hospitals charge more than independent doctors for the same procedure. Sometimes several times more. For instance, a heart catheterization in a freestanding center costs around $1,100, while the same procedure costs $4,000 in a hospital outpatient setting. “The disparities create incentives for hospitals to buy physician practices, which drives costs up for everyone: Medicare, private insurance companies, employers, employees and patients,” the 2013 MedPAC report concluded.

A study published in the Journal of the American Medical Association (Oct. 22) further substantiated the higher costs. The California study, which included 4.5 million patients seen between 2009 and 2012, found a significant difference in the mean inpatient costs when comparing patients of independent doctors, of doctors employed by a hospital, and of doctors employed by a multi-hospital system: • Independent doctor: $3,066 (Mean cost per inpatient) • Hospital-owned doctor: $4312 • Multi-hospital-system-owned doctor: $4776

18 FLORIDA MD - NOVEMBER 2014

It adds up.

“If hospital facilities charged the same as independent doctors for the same services for 66 groups of services, taxpayers would save $900 million a year in Medicare costs,” said MedPAC. Imagine if insurance providers also brought their contracted rates with hospitals in line with their reimbursement rates for private practitioners.

5. Communities lose jobs. Independent practices are small businesses. Small businesses create about 65 percent of our nation’s new jobs, and are vital to the market dynamics of healthy communities. When independent doctors sell to hospital systems and become employees, the hospital takes over staffing and that often means loyal office workers lose their jobs.

6. Taxes go up: When a nonprofit health system acquires an independent physician’s practice, that practice overnight goes from supporting the community through paying property, tangible and sales taxes to paying no taxes. We all pay for that.

7. Job satisfaction and security go down: Employed doctors often find the best year of employment is the first one. After that, contracts often get worse, if they get renewed at all. Remember, employed physicians’ jobs, salaries and benefits – can depend on their numbers.

Because most physicians usually have to sign a non-compete agreement as a condition of employment, if they leave, or their contracts aren’t renewed, some aren’t allowed to practice in the area again for a specified period of time.

Most physicians don’t want to be part of the fallout that occurs when hospitals acquire them, but many also feel they don’t have a choice.

We think they do.

The Association of Independent Doctors is a fast-growing, national nonprofit organization designed to help independent doctors stay that way. Since it was established in April 2013, the association has grown to include members in eight states.

“We fight a fight that doctors have neither the time, means, nor clout to pursue,” said Thomas.

By organizing physicians in the fight to stay independent, A.I.D. communicates to patients, insurance providers, and government representatives the important reasons why our health-care system needs physicians to remain independent. For more information, go to www.aid-us.org.

Join me next month when we explore what one association can do.

The experience you demand.

The customer care you deserve.

Marni Jameson is the executive director for the Association of Independent Doctors. You may reach her at 407-865-4110 or marni@aid-us. org. 

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Alzheimer’s Dementia--- Is It Preventable?

By Ira Goodman, MD Alzheimer’s disease is characterized by two signature proteins, the amyloid plaques, outside of brain cells, and the Tau tangles, inside brain cells. Although these pathological hallmarks of Alzheimer’s disease were first described by Dr. Alois Alzheimer well over 100 years ago, the pathogenesis has not yet been clearly defined. Current FDA-approved and investigational treatments are based on the most popular theory, the “amyloid cascade hypotheses”, which describes a “trigger-bullet” process where the extracellular amyloid plaque triggers the hyper phosphorylation of the intracellular Tau forming insoluble neurofibrillary tangles. These pathologic changes appear to begin decades prior to the onset of neurodegeneration and clinical symptoms. However, they can also be seen with normal aging. In fact when Dr. Alzheimer first described the disease pathologically, the presence of the amyloid plaque was already well-known and felt to be a part of normal aging. Some older individuals develop a very large amount of amyloid plaque (termed “pathological aging”) with virtually no Tau tangles, and although some may have abnormal neuropsych testing, they do not appear to develop dementia. Hence, both proteins need to be present to make the pathological diagnosis of

definite Alzheimer’s disease, although in rare cases, a patient with dementia can present a large amount of tangles with few plaques (termed “tangle predominant Alzheimer’s disease”).

Two of the strongest risk factors for the development of Alzheimer’s dementia are (1) advancing age, with the incidence and prevalence doubling every 5 years over the age of 65, as well as (2) genetic predisposition. The rare cases of early onset Alzheimer’s disease, with the clinical age of onset typically in the 30s to 50s, are familial and inherited in an autosomal dominant fashion.

Three major mutations have been linked to those cases, the most common one being on Presenilin. For the more typical late onset Alzheimer’s disease, which represent over 95 percent of patients, multiple gene changes have been described.

Contrary to the familial form of the disease, those do not predict who will develop the disease but instead indicate an increased risk. The most well-known one is the ApoE4 allele. On the other hand, some gene changes have been shown to be protective against the development of Alzheimer’s disease, such as the ApoE2 allele as well as the more recently discovered “Icelandic Mutation”.

The Icelandic mutation prevents the cleavage of the amyloid precursor protein and thus the formation of amyloid plaques. The presence of this mutation, affecting about 1 in a 100 inhabitants of Iceland, results in a significant decrease in the development of Alzheimer’s disease and appears to have a Principals — All working together for you! protective effect even in patients with the • Corporate Retirement Plans ApoE4 allele.

• Complex Benefits Strategies • Individual and Family Estate Planning FDA-approved pharmacologic treat• HR and Benefits Compliance Solutions ments for Alzheimer’s disease are symp• Customized Insurance Products and Services tomatic, they target the symptoms of the • Financial Planning and Wealth Management disease, not its causes (the plaques and the tangles). These treatments have proven disExperience. Knowledge. Strategy. appointing over the last 20 years or so since T. Kevin Taylor, JD, LLM* first introduced. The last FDA-approved 1407 E. Robinson Street treatment for Alzheimer’s dementia, MeOrlando, FL 32801 mantine, was approved over 10 years ago. www.vaughngroup.com Other approaches have come from medical food. Axona is a coconut oil-based mediOffice: (407) 898-3911 cal food currently regulated by the FDA Toll Free: (800) 940-0990 and has been available for about 5 years. *Securities and Investment Advisory Services may be ofA phase 3 clinical trial is ongoing, which fered through NFP Securities, Inc., Member FINRA/SIPC. if positive may lead to FDA approval of NFP Securities, Inc. is not affiliated with The Vaughn Axona as the most recent pharmacologic/ S. Kyle Taylor* Group, Inc. metabolic strategy to treat Alzheimer’s dis-

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ease. Based on earlier phase 2 trials, it appears to be effective only in patients who are ApoE4 negative.

can be implemented alone or along with the available and soon to come pharmacologic options.

These treatments however are only symptomatic and typically have limited short-lived efficacy, if any. Research is looking at disease modifying treatments, targeting the causes of the disease.

There are multiple ongoing clinical trials targeting both the amyloid plaques and Tau tangles. Thus far, at least with the efforts targeting the amyloid protein, the results have not been as good as expected. However, these proteins begin to form decades prior to the onset of clinical symptoms and it is felt that perhaps in those studies the patients began treatment too late in the disease.

Indeed, patients who began treatment with very minimal symptoms did seem to show a better response. An ongoing study, in part sponsored by the National Institute of Health, is targeting patients who have amyloid plaques, as documented by an amyloid labeling cerebral PET scan, but no symptoms of dementia.

It is hoped that by removing the amyloid, the progression of the disease can be prevented or slowed down.

Ira Goodman, MD, is Director of Neurosciences at Compass Research. He is a board-certified neurologist specializing in Parkinson’s disease and memory disorders such as dementia and Alzheimer’s disease. Dr. Goodman is also an associate professor of neurology at the University of Central Florida College of Medicine, as well as an associate clinical professor of neurology at the University of Florida College of Medicine. Goodman was named “Top Neurologist in the Country” by U.S. News & World Report and ranked “Top Neurologist in Central Florida” for 14 consecutive years by Orlando Magazine. To contact Compass Research, please call 407-426-9299. 

Two patients with the same amount of plaques and tangles Coming UP Next Month: The cover story could have their memory affected at different levels. This wellfocuses on Compass Research, a clinical known “disconnect” has been attributed to environmental factors research company dedicated to testing during life such as mental and physical stimulation, socialization, investigational medications that cover a a diet high in polyphenols (antioxidants), found in bright fruits broad range of diseases and disorders. and dark vegetables, and low in saturated and trans-fats. Likewise Editorial focus is on Pain Management and it appears that a low carbohydrate diet may be good for more than Occupational Therapy. glycemic and weight control. Stress management may also play a role with regards to lowering Cortisol levels leading to lower glucose and insulin levels.

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Digestive and Liver Update

Common Cause of Diarrhea : Microscopic Colitis

By Harinath Sheela, MD

Microscopic colitis is inflammation of the bowel that is only visible using a microscope. Microscopic colitis is a common cause of chronic watery diarrhea and gastrointestinal symptoms.

Diarrhea can range from mild and intermittent to severe and persistent, and can adversely affect quality of life, especially if there is significant fecal incontinence. The disorder gets its name from the fact that it’s necessary to examine colon tissue under a microscope to identify it. Microscopic colitis causes diarrhea without bleeding and can also be associated with fecal urgency and typically occurs in middle-aged woman. Rates of microscopic colitis are similar to other forms of IBD, affecting about nine people in 100,000. Although microscopic colitis affects both men and women, collagenous colitis is much more common in women.

Microscopic colitis is less severe than other types of IBD because it does not lead to cancer and rarely requires surgery. However, microscopic colitis can cause considerable pain and discomfort.

Microscopic colitis affects the colon and rectum. Two different types of microscopic colitis have been generally recognized: Collagenous colitis and lymphocytic colitis.

The symptoms of and treatment for both are identical. Some scientists believe the two forms may be different presentations of the same disease. Slight differences in the way intestinal tissues appear when seen with a microscope set them apart. In both forms, an increase in white blood cells can be seen within the intestinal epithelium—the layer of cells that lines the intestine.

Increased white blood cells are a sign of inflammation. But with collagenous colitis a thick layer of protein (collagen) develops in colon tissue.

Collagen is a structural protein in bones and cartilage. In the intestines, collagen anchors the intestinal epithelium to underlying layers of tissue. The thicker collagen layer seen with collagenous colitis may result from inflammation. Lymphocytic colitis, in which white blood cells (lymphocytes) increase in colon tissue.

Symptoms Chronic watery and non bloody diarrhea is the main symptom of microscopic colitis. Episodes of diarrhea can last for weeks, months, or years. Most cases are interrupted by similarly long periods of remission—times when diarrhea goes away. The clinical course is mainly intermittent, but is sometimes continuous or rarely consists of single episode.

Other common symptoms of microscopic colitis include • abdominal cramps or pain • abdominal bloating 22 FLORIDA MD - NOVEMBER 2014

Less common symptoms of microscopic colitis include • mild weight loss • dehydration • nausea • weakness • fecal incontinence—inability to control a bowel movement

Pathogenesis: The pathogenesis of the different forms of microscopic colitis is unknown despite a detailed description of their pathology. It remains uncertain whether collagenous and lymphocytic colitis are related. The inflammatory cell response is similar in the two disorders. Furthermore, there is often significant histologic overlap. In one study, colonic biopsy was performed in 30 patients with chronic watery diarrhea and normal radiographic and endoscopic studies: 6 showed lymphocytic colitis alone; 7 showed collagenous colitis alone; and 17 showed a mixed form with both thickening of the collagenous plate and an increased number of intraepithelial lymphocytes The extent to which there may be a genetic predisposition to microscopic colitis is unclear. However, familial cases have been described. Interestingly, different members of the same family developed either lymphocytic or collagenous colitis, supporting a similar underlying pathophysiology. The cause of microscopic colitis is unknown. Many scientists believe it is an abnormal immune response triggered by something in the gastrointestinal (GI) tract—the large, muscular tube that extends from the mouth to the anus and digests food. Normally, the immune system is triggered by germs, but sometimes it reacts to harmless bacteria, pollen, food, or even the body’s own cells. The belief that something in the GI tract causes microscopic colitis is supported by evidence that the colon, when empty for a long time, recovers from inflammation. Keeping the colon empty is accomplished through a surgical procedure called an ileostomy, which diverts digestive waste away from the colon to an opening in the abdomen. The belief is further supported by the fact that inflammation returns when the ileostomy is reversed and the normal digestive route through the colon is restored.

Harmful and harmless bacteria. Some people get microscopic colitis after being sick with certain harmful bacteria, including Yersinia enterocolitica, Campylobacter jejuni, and Clostridium difficile. Other people test negative for these and other harmful bacteria, but their condition improves with antibiotic treatment, suggesting normally harmless bacteria in the colon may trigger microscopic colitis in some people.

Digestive and Liver Update Medications

• acarbose (Prandase)

exclude other inflammatory diseases. While colonoscopy is generally safe in such patients, an increasing number of perforations have been described in patients with severe collagen deposits (“fractured colon”). Crypt architecture is usually not distorted, but focal cryptitis may be present.

• aspirin

Treatment

• lansoprazole (Prevacid)

Treatment for microscopic colitis often begins with eliminating medications with suspected links to microscopic colitis and cutting out foods that can make diarrhea worse, including foods containing caffeine, high-fat foods, and dairy products.

No medications have been proven to cause microscopic colitis but several have been linked to it, including

• nonsteroidal anti-inflammatory drugs • ranitidine (Zantac)

Antidiarrheal medications such as bismuth subsalicylate (Pepto-Bismol) and loperamide (Immodium) are effective for some patients.

• sertraline (Zoloft) • ticlopidine (Ticlid) Food. Certain foods appear to trigger microscopic colitis in some people. Although no specific foods have been identified, following a caffeine- or lactose-free diet sometimes improves symptoms.

Diagnosis:

If diarrhea persists, medications called corticosteroids may help, including prednisone and budesonide (Entocort). Corticosteroids have many potential side effects including insomnia, fluid retention, and mood swings. Budesonide has fewer side effects than other corticosteroids and has been shown to be effective for treating microscopic colitis.

Other medications used to treat microscopic colitis include Microscopic colitis can only be diagnosed by examining intesmesalamine and cholestyramine (Questran). tinal tissue removed during colonoscopy or flexible sigmoidoscopy—procedures that use a lighted, flexible scope to see inside Summary and Recommendations: the colon and rectum. The term microscopic colitis implies that Microscopic colitis is characterized by chronic watery (secrethe diagnosis is made by histology. Thus, colonoscopy usually reveals macroscopically normal colonic mucosa, although slight edema, erythema, and friability may be seen. In small case series, chromoendoscopy using indigo carmine highlighted mucosal alterations that correBudget Season: Coming Out Ahead spond to the histological distribution of mi(Without a Headache) croscopic colitis However, larger studies are needed before routine use of chromoendosNovember 20, 2014 | 12:00 p.m. copy can be recommended for the diagnosis of microscopic colitis.

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Although specimens obtained by flexible sigmoidoscopy are frequently sufficient to establish the diagnosis. The severity of histologic changes declines from the proximal to the distal colon; thus, biopsies obtained from the right colon are optimal. Collagenous colitis can be patchy, with normal mucosa being found mainly in specimens from the rectosigmoid. In several reports, rectosigmoid biopsies alone would have missed the diagnosis of collagenous colitis in up to 40 percent of cases. In a retrospective analysis of histologic specimens from 56 patients, the highest diagnostic yield was achieved in biopsies from the transverse colon (83 percent) and right colon (70 percent), and lowest in the rectosigmoid (66 percent) Thus, total colonoscopy is necessary to establish the diagnosis of collagenous colitis and to

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Digestive and Liver Update tory) diarrhea without bleeding. It usually occurs in middle-aged patients, but can affect children. The colon appears normal by colonoscopy or computed tomographic (CT) colonography. The diagnosis is established by biopsy of the colonic mucosa which reveals colitis, but not mucosal ulcerations.

Two different types of microscopic colitis are generally recognized: • Lymphocytic colitis • Collagenous colitis without lymphocytic infiltration of the surface epithelium Therapeutic options are based mainly upon controlled trials of budesonide, limited reports of other approaches in small numbers of patients, and an appreciation of the natural history.

• Patients should be reassured since microscopic colitis has not been associated with increased mortality or severe deterioration.

• Drugs known to be associated with microscopic colitis should be discontinued.

• Patients should be tested for celiac disease; a gluten-free diet should be recommended if the diagnosis is established.

States. (See ‘Glucocorticoids’ above and ‘Bismuth subsalicylate’ above.)

Other causes of diarrhea should be excluded in patients with microscopic colitis who fail to respond to medical therapy. A gluten-free diet should be considered in patients unresponsive to medical treatment because of a possible association of microscopic colitis with gluten sensitivity even in the absence of overt celiac disease.

Harinath Sheela, MD moved to Orlando, Florida after finishing his fellowship in gastroenterology at Yale University School of Medicine, one of the finest programs in the country. During his training he spent significant amount of time in basic and clinical research and has published articles in gastroenterology literature.

His interests include Inflammatory Bowel Diseases (IBD), Irritable Bowel Syndrome (IBS), Hepatitis B, Hepatitis

• For patients with lymphocytic or collagenous colitis with troubling symptoms, we recommend budesonide (Grade 1B). We usually give 9 mg/day for four weeks. If the patient is in remission, we taper to 6 mg for two weeks, to 3 mg for another two weeks, and then discontinue therapy. If the symptoms are not controlled or if symptoms recur on tapering, the dose of 9 mg can be continued for 12 weeks or longer before tapering budesonide.

C, Metabolic and other liver disorders. He is a member of

• In patients who do not respond to budesonide, we suggest a short course of aminosalicylate (up to 1.5 g three times per day) (Grade 2C). If an aminosalicylate is not effective, we suggest a short trial of cholestyramine (4 g four times per day) (Grade 2C). (See ‘Aminosalicylate/sulfasalazine’ above and ‘Cholestyramine’ above.)

Dr. Sheela is a Clinical Assistant Professor at the University

• If cholestyramine is not effective, we suggest a trial of systemic glucocorticoids (Grade 2C). An alternative may be a trial of bismuth subsalicylate, which is used mainly in the United

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24 FLORIDA MD - NOVEMBER 2014

the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the American Association for the Study of Liver Diseases (AASLD) and Crohn’s Colitis foundation (CCF).

of Central Florida School of Medicine. He is also a teaching attending physician at Florida Hospital Internal Medcine Residency and Family Practice Residence (MD and DO) programs.

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Florida MD goes to physicians at their offices, in the thirteen-county area of Orange, Seminole, Volusia, Osceola, Polk, Flagler, Lake, Marion, Sumter, Hardee, Highlands, Hillsborough and Pasco counties. Cover stories spotlight extraordinary physicians affiliated with local clinics and hospitals. Special feature stories focus on new hospital programs or facilities, and other professional and healthcare related business topics.

Local physician specialists and other professionals, affiliated with local businesses and organizations, write all other columns or articles about their respective specialty or profession. This local informative and interesting format is the main reason physicians take the time to read Florida MD. It is hard to be aware of everything happening in the rapidly changing medical profession and doctors want to know more about new medical developments and technology, procedures, techniques, case studies, research, etc. in the different specialties. Especially when the information comes from a local physician specialist who they can call and discuss the column with or refer a patient. They also want to read about wealth management, financial issues, healthcare law, insurance issues and real estate opportunities. Again, they prefer it when that information comes from a local professional they can call and do business with. All advertisers have the opportunity to have a column or article related to their specialty or profession.

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