RPM April 2014, Vol 2, No 2 by Value-Based Cancer Care

PROCESS IMPROVEMENTS TO ENHANCE PATIENT CARE™ APRIL 2014

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Volume 2 • Number 2

PRACTICE MANAGEMENT Clinic Profile

Piedmont Arthritis Clinic:

A Conversation with Nancy Ellis, MBA/MHA, Practice Administrator

Challenges of Starting a New Ancillary Service

By Kyle C. Harner, MD, Managing Partner, Carolina Arthritis Center, Greenville, NC

ased on group preferences and state laws, rheumatology physicians may or may not write narcotic prescriptions for patients as part of chronic pain management. In Eastern North Carolina, primary care providers seldom write such prescriptions, and outside of pain management clinics,

patients have limited options for pain control. Because of this, the 3 physicians in our practice prescribe narcotics for patients who we feel need long-term arthritis pain control. We have a protocol to manage these prescriptions that is in compliance with the North Carolina Medical Board. Continued on page 8

From the Editor

The S Model of Rheumatology By Iris W. Nichols, President, National Organization for Rheumatology Managers; Editor-in-Chief, Rheumatology Practice Management

ancy Ellis’ day starts with a morning walk around the office to greet colleagues and get a feel for pressing issues of the day. The administrator of a busy rheumatology practice, Ms Ellis may run into any of the 26 people who work at Piedmont Continued on page 5

e are all aware of the many challenges and opportunities we face in rheumatology practices. As we see from the countless articles, news blurbs, and listserv postings, we all encounter similar things. We strive for quality improvement (our physicians are known to be leaders in this area), we have ongoing perfor-

mance indicators that examine practice quality as well as costs, and we evaluate our practices by comparing them to yesterday, looking at how they exist today, and preparing them for tomorrow. I recently returned from a meeting where we discussed partnering together to meet these challenges. As I outlined my thoughts to prepare for Continued on page 9

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VOLUME 1 • NUMBER 2

PRACTICE MANAGEMENT

Reflections on the NORM 2013 Annual Conference

By Jay Salliotte Business Manager, Advanced Rheumatology, Lansing, MI

Long Beach, CA—As I was packing up my bags to return home from the National Organization of Rheu matology Managers (NORM) 8th Annual Conference, I had the television on in the background. I over heard part of a poem that I later learned was written by Wendell Berry. The poem is entitled, “In A Country Once Forested,” and the lines that most struck me were: “...and the soil under the grass is dreaming of a young forest/and under the pavement the soil is dreaming of grass.” As tired and travelweary as I was, my mind was still in spongemode—ready Continued on page 10

From the Editor

Sharing Our Success

™

By Iris Nichols President, National Organization of Rheumatology Managers

fter months of preparation, the National Organization of Rheu matology Managers (NORM) 8th Annual Conference was held the weekend of September 1314, 2013, in Long Beach, CA. This year’s conference brought together managers from 150 practices in 35 states.

We had our first practice from Hawaii represented this year. The conference began with a welcome reception where new and established members, vendors, sponsors, commit tee members, and board members were identified by unique ribbons on their badges. Many of our members had asked Continued on page 9

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NORM Meeting Proceedings

Healthcare Reform: Stakeholder Integration Is Key to Improving Care By Sandra Paton

Long Beach, CA—Healthcare expendi tures in the United States are currently approximately 18% of the gross domestic product (GDP), and this is projected to rise, unless there is a change in the way care is delivered in the United States.

A considerable part of the healthcare costs is spent on chronic diseases in the United States. For baby boomers, this often means 2 or more chronic illnesses. Continuing or adding to the current cost trend would be devastating to the US Continued on page 13

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In This Issue

PUBLISHING STAFF Senior Vice President/Group Publisher Nicholas Englezos nenglezos@the-lynx-group.com Director, Client Services Zach Ceretelle zceretelle@the-lynx-group.com Editorial Directors Dalia Buffery dbuffery@the-lynx-group.com Anne M. Cooper acooper@the-lynx-group.com Associate Editor Lara J. Lorton Editorial Assistants Jennifer Brandt Cara Guglielmon Production Manager Melissa Lawlor The Lynx Group President/CEO Brian Tyburski Chief Operating Officer Pam Rattananont Ferris Vice President of Finance Andrea Kelly Human Resources Jennine Leale Associate Director, Content Strategy & Development John Welz Associate Editorial Director, Projects Division Terri Moore Director, Quality Control Barbara Marino Quality Control Assistant Theresa Salerno

PROCESS IMPROVEMENTS TO ENHANCE PATIENT CARE™ April 2014

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Volume 2 • Number 2

PRACTICE MANAGEMENT

From the Editor

™

The S Model of Rheumatology................................................................. 1 By Iris W. Nichols

Clinic Profile

Piedmont Arthritis Clinic: A Conversation with Nancy Ellis, Practice Administrator................................................................................ 1 Best Practices

Challenges of Starting a New Ancillary Service.................................. 1 By Kyle C. Harner, MD

Practice Administration

Team Stress: Controlling Its Impact on Your Bottom Line................. 10 By Sandra Paton

Director, Production & Manufacturing Alaina Pede

Continued on page 4

Director, Creative & Design Robyn Jacobs Creative & Design Assistant Lora LaRocca Director, Digital Media Anthony Romano Web Content Managers David Maldonado Anthony Trevean Digital Programmer Michael Amundsen Meeting & Events Planner Linda Sangenito Senior Project Managers Andrea Boylston Jini Gopalaswamy Project Coordinators Deanna Martinez Jackie Luma IT Specialist Carlton Hurdle Executive Administrator Rachael Baranoski Office Coordinator Robert Sorensen Engage Healthcare Communications, LLC 1249 South River Road - Ste 202A Cranbury, NJ 08512 phone: 732-992-1880 fax: 732-992-1881

BPA Worldwide membership applied for January 2014.

Mission Statement Rheumatology healthcare requires providers to focus attention on financial concerns and strategic decisions that affect the bottom line. To continue to provide the high-quality care patients deserve, providers must master the ever-changing business of rheumatology. Rheumatology Practice Management offers process solutions for members of the rheumatology care team—physicians, nurses, and auxilliary clinical staff, as well as executives, administrators, and coders/billers—to assist them in reimbursment, staffing, electronic health records, REMS, and compliance with state and federal regulations.

Rheumatology Practice Management™, ISSN 2164-4403 (print), is published 6 times a year by Engage Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Copyright © 2014 by Engage Healthcare Communications, LLC. All rights reserved. Rheumatology Practice Management™ is a registered trademark of Engage Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the publisher. Printed in the United States of America. The ideas and opinions expressed in Rheumatology Practice Management™ do not necessarily reflect those of the editorial board, the editors, or the publisher. Publication of an advertisement or other product mentioned in Rheumatology Practice Management ™ should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturers about any features or limitations of products mentioned. Neither the editors nor the publisher assume any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material mentioned in this publication. Postmaster: Correspondence regarding subscriptions or change of address should be directed to CIRCULATION DIRECTOR, Rheumatology Practice Management™, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Fax: 732-992-1881. Yearly subscription rates: 1 year: $99.00 USD; 2 years: $149.00 USD; 3 years: $199.00 USD.

April 2014

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In This Issue

Continued from page 3

Wealth Management

Your 401(k) Plan Stinks: 3 Ways to Make the Best of a Bad Situation................................................ 12 By W. Ben Utley, CFP®; and Lawrence B. Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF

Medical Legal Update

The Cost of Using Free Images for Your Website................................................................................. 16 By Caroline P. Wallitt, Esq; and Jennifer A. Kirschenbaum, Esq

Drug Update

Simponi Aria (Golimumab): A New Intravenous TNF Inhibitor for Patients with Rheumatoid Arthritis...................................................................................................................... 19 By Loretta Fala, Medical Writer

Editorial Advisory Board Editor-in-Chief Iris W. Nichols

President National Organization of Rheumatology Managers Wilmington, NC Practice Administrator Arthritis & Osteoporosis Consultants of the Carolinas Charlotte, NC

Ana Reyes-Cartagena

Director of Clinical Practice Arthritis & Rheumatism Associates, P.C. Wheaton, MD

Allyson D. Eakin, RN, OCN, CCM

Clinical Research Coordinator Arthritis & Osteoporosis Consultants of the Carolinas Charlotte, NC

Kyle Harner, MD

Helen Hinkle

Linda McKee

Mark Post

Jay Salliotte

Practice Administrator Rheumatic Disease Associates Ltd Willow Grove, PA

Practice Administrator Premier HealthCare Associates, Inc Richmond, VA

Nancy Ellis

Practice Administrator Piedmont Arthritis Clinic Greenville, SC

Marjorie Collings

RHEUMATology Practice Management

Carolina Arthritis Center Greenville, NC

Administrator North Texas Joint Care, P.A. Dallas, TX

I April 2014

Office Administrator Rheumatology Associates of South Texas San Antonio, TX

Business Manager Advanced Rheumatology Lansing, MI

Clinic Profile

Piedmont Arthritis Clinic...Continued from the cover Arthritis Clinic. Nurses, medical assistants, nursing assistants, physicians, and the administrative staff comprise the talented team that works together each day to treat the approximately 150 patients who walk through the doors. Between the physicians, staff, and patients, Ms Ellis enjoys a day that is anything but routine. “A big part of why I love the job is that it’s an endless variety of things,” she said during a recent interview with Rheumatology Practice Management. “What you think you are going to do is never what you end up doing, and what you end up doing is something you probably never thought you would do. You can’t ever come in and say you’re bored. It is a constant variety and juggling act, and you learn how to juggle and smile and hopefully keep all your balls in the air and keep a good sense of humor.” Ms Ellis holds a joint master’s degree in business and health admin istration (MBA/MHA), and after working in a hospital as well as large and small private practice settings, she found her home 5 years ago at Piedmont, where 4 physicians and a nurse practitioner see patients with a range of diseases, including rheumatoid arthritis, lupus, ankylosing spondylitis, psoriatic arthritis, among others. The clinic also offers intravenous therapy of 10 drugs in its infusion suite, localized extremity magnetic resonance imaging, bone densitometry, and vertebral fracture analysis.

Information Management Maintaining accurate information is critical to the clinic, and from the moment patients enter Piedmont to well after they leave, the data they share with the front desk provide essential information along the way. Ms Ellis credits a smooth flow of information in large

part to team effort among the staff as well as to eClinicalWorks, their electronic medical record software, which is used throughout the clinic. The program’s ability to integrate a practice management program with electronic medical health records data has been key to connecting the front office to physicians and back office staff. Piedmont’s administrative and clinical staff work to maintain awareness that everyone’s efforts are interconnected, Ms Ellis said. She cites a recent example where a patient presenting a health exchange insurance card was processed as having a private plan. The 2 plans were adminis-

“We tend to think and work in silos. A lot of our education internally right now is making sure people realize that what they do isn’t just in their silo. Patient information entered in the system will ultimately affect things down the road, all the way to claims processing.” —Nancy Ellis, MBA, MHA tered by the same parent company but were vastly different. Until the error was discovered, staff at the center made attempts to obtain prior authorizations that were not actually

needed. The experience became a valuable lesson in the importance of reviewing a patient’s insurance card in its entirety and ensuring that data entered into the system are accurate. “We tend to think and work in silos,” Ms Ellis said. “A lot of our education internally right now is making sure people realize that what they do isn’t just in their silo. Patient information entered in the system will ultimately affect things down the road, all the way to claims processing.”

Going the Extra Mile Ms Ellis is proud of how the practice cares for its patients, but is even more proud of how it cares specifically for patients who receive infusion therapy. Staff at the clinic go the extra mile to ensure that patients know their costs up front and have access to financial support if the cost of care is a financial burden. This may increase the amount of time from the point intravenous drugs are prescribed to the point patients first enter the infusion suite, but in the end, Ms Ellis points out, the wait is worth it. “We may take a while to get someone on an infusion service but once they’re there we know we’ve covered everything,” Ms Ellis said. “We’ve verified their insurance, we know how they are going to pay for it. If they’ve needed foundation monies we’ve helped them get that. We’ve Continued on page 6

April 2014

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Clinic Profile

Piedmont Arthritis Clinic...Continued from page 5 lined everything up the best we can for them. Sometimes that process takes a little bit of time, so you can’t say today that you’re going to put someone on tomorrow. A lot of it depends on their insurance, but we have a very good process for that.”

Affordable Care Act On the topic of health insurance, Ms Ellis estimated that approximately 45% of the patients seen in the practice have Medicare, and the balance present with commercial plans that are a mix of private insurance and marketplace exchanges offered through the Affordable Care Act (ACA). Piedmont directly contracted with 2 of the federally facilitated exchanges offered in its home state of South Carolina, learning later that the clinic is on the panel for a third plan in the state, but not the fourth. South Carolina is one of several states that opted to use the federally facilitated plans as opposed to a state-based health insurance marketplace; a total of 4 exchange plans were open to patients for enrollment through March 31. Ms Ellis noted that education re-

garding the exchange program has taken place both internally among staff and externally to patients. Some patients have come in understandably confused about the extent of their coverage and associated costs, and staff have worked hard to

patients to web pages that explain the exchanges and summarize approved plans. The now well-studied 90-day grace period that is part of the exchange plans’ fine print has been a cause for concern among many

Education regarding the exchange program has taken place both internally among staff and externally to patients. Some patients have come in understandably confused about the extent of their coverage and associated costs, and staff have worked hard to understand details of the exchange plans that the office accepts. understand details of the exchange plans that the office accepts. Team members have risen to the challenge of explaining to patients whether their cost-share is 20%, 30%, or 40% of their total cost of care through one-on-one interactions as well as general patient education. Links on Piedmont’s website direct

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I April 2014

practices, no matter the medical specialty. The provision of the ACA allows patients who receive an advance premium tax credit to enter into a 90-day grace period if they are overdue on their premium payments. During the first month of the grace period, the patient continues to have insurance coverage, but in the second and third months, insurers can hold claims pending payment. Once the patient pays his premiums in full prior to the end of the grace period, he will retain coverage; if premiums are not paid within that time, however, he will no longer be covered, claims from the second and third months will be denied, and the patient will be responsible for payment. Although practices must be notified of the grace period, when and how they are notified are not specified. Practices have been trying to determine how best to handle the uncertainty associated with the grace period to avoid the patient or the practice being faced with an unpaid bill. At Piedmont, they have

Clinic Profile

decided to request proof that patients are current on premiums only for higher-ticket procedures such as infusions, magnetic resonance imaging, or ultrasounds. “This practice just decided that, on the routine office visit side of it, the dollars weren’t enough for us to require all of those people to provide proof. Especially longstanding patients, we didn’t want to do that,” Ms Ellis said. “There is some customer service aspect to that, how to finesse it without making patients feel badly. We’ve tried to phrase it so they know the request is a protection for the patient, so they are not stuck with a large bill.”

Marketing the Practice Piedmont is an independent, referral-based practice. Although it is within a hospital complex, it saw its referrals begin to drop in recent years as primary care physicians (PCPs) and orthopedists bought by the hospital turned toward rheumatology practices within their internal networks, Ms Ellis said. To address the problem, Piedmont worked to build relationships with PCPs and orthopedists within the hospital complex, emphasizing its ability to see patients quickly. By highlighting the benefits of coming to Piedmont, and offering to reciprocate with referrals for procedures it didn’t offer onsite, the clinic was able to build relationships and attract traffic back to its office. It has also turned to the Internet and Facebook, and through the strategic use of a marketing company, Piedmont has been able to reach existing and potential patients, Ms Ellis said. In an attempt to drive traffic to its Facebook page in recent years, the clinic began offering incentives for “liking” the page, including tickets to football games at Clemson University, a popular college in the region. Facebook followers, which have reached 3000, were

then continuously engaged with regular posts pertinent to rheumatic or general health. “We thought after the contest and giveaways, people would drop off, but they never did,” Ms Ellis said. “Every day, every other day, we’re out there posting something about one of our diagnoses, exercise in general, or healthy eating. Seeing those posts come from us, patients see us in a social media context as a leader. And when they need a doctor, they think about us because we are putting good, quality information in front of them on a consistent basis.” The marketing company manages the Facebook page and regular posts, and Piedmont’s physicians approve all content before it reaches the public, Ms Ellis said. The company also oversees Piedmont’s website, which has been revamped to engage patients with photos, videos, and easy access to information. Visitors to the site can download forms, check records or laboratory results, request appointments, or find information on insurance plans, the physicians, and the practice. The clinic has focused on making the page more dynamic, attractive, and easier for the end user. A new page with patient education videos is in the works.

April 2014

Working Hard and Having Fun Ms Ellis enjoys working with the team at Piedmont, she said, where she finds a great balance of humor and hard work. A fan of flamingos, she has brought some of her flamingo collection from home to decorate her office. Her work family quickly came onboard with it, convincing her to buy a life-sized metal flamingo, which now has a year’s worth of outfits to mark birthdays, holidays, and seasons. The dressed-up bird that stands in her office, in some ways, she said, represents the office culture. “You spend so much time here, and some of the things we see can be depressing to some extent,” she said. “We try to handle things with a sense of humor. We do it professionally, but we also try to make it fun and make it easier. We try not to add a whole lot of unnecessary stress, either on us or on the patient.” l Nancy Ellis is a member of the editorial board of Rheumatology Practice Man agement. Piedmont Arthritis Clinic is located in Greenville, SC, in the Saint Francis Hospital complex. The practice can be reached by calling 864-2358396, or visit www.piedmontarthritis. com for more information.

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Best Practices

Challenges of Starting a New Ancillary...Continued from the cover To better serve our patients and keep as much revenue as possible in-house, our clinic recently started performing and charging for our own urine drug screens (UDSs) as part of our narcotic dispensing protocol. We already have a robust inhouse laboratory that handles the majority of the blood and urine testing that we need daily to evaluate and treat our patients. In the past, we were sending UDSs to an outside laboratory for testing. While these screens were accurate, the turnaround time was as much as 2 weeks, making it difficult to develop timely clinical decisions based on the screen results. As with any new project we take on as a clinic, bringing UDSs in-house has been a challenge, from both practice management and clinical perspectives. This article focuses on the practice management challenges. The first challenge we have faced is the need to adopt new policies and protocols to cover in-house UDSs. Some of these policies were in place for the screens we were sending to an outside laboratory, but we had to develop new protocols to handle the same-day results of our testing. As with any new test, unexpected results are leading to policy changes that continue to evolve. Instituting any new ancil-

Kyle C. Harner

The key to tackling all of these challenges is an excellent management team. We have superb managers, and I know they make my job easier and allow me to focus on patients. lary service will cause some growing pains at the onset, and we have found that a little bit of flexibility with new policies can help smooth the transition. The second challenge is adapting

KEY POINTS Starting a new ancillary service may pose some challenges: New policies and protocols are needed to address the expected—or unexpected—consequences of a new service.

➤

New services may require additional space. Are there unused examination rooms or offices that can be used temporarily until a permanent space solution is found?

➤

Additional staff may be needed to accommodate a new service. It is important to examine whether a full-time or part-time position needs to be added, or whether existing staff can increase their hours.

➤

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to the space needed to perform UDSs. Even though the testing cups we are using are self-contained and require no additional chemicals, the testing still requires a certain amount of counter space. The amount of space needed varies based on the number of screens being done at any given time. During peak times, our laboratory has been pushed to capacity with both regular blood draws and UDSs. We are fortunate to have extra exam rooms that we can use for counter space, but we have also been talking about the possible need to expand our laboratory area (an expensive remodeling that would be better to avoid). The third challenge is staffing. As with the space issue, the sheer number of UDSs we perform is making our already-busy laboratory staff even busier. Patients are waiting longer for testing, to the point that we have converted an office space into a new waiting area. We are experimenting with staffing options, including giving extra hours to nonlaboratory staff. In the end, we may have to add a parttime position to our laboratory staff to accommodate the extra volume. The key to tackling all of these challenges is an excellent management team. We have superb managers for our laboratory, personnel, and administration, and as the managing partner, I know they make my job easier and allow me to focus on patients. In fact, it was the laboratory manager’s idea to bring this testing in-house. This kind of forward thinking gives us the tools to develop diagnoses much sooner and provide better care to our patients. It also helps our practice to bring more ancillary services under our control, thereby giving away less revenue on a day-to-day basis. In the current healthcare environment, such forward thinking is essential for private practices to stay in business. l

From the Editor

The S Model...Continued from the cover the meeting, this is what developed, just by luck: Struggles. All practices struggle to determine where they fit in the current rheumatology space. Survival. Whether they have 1, 2, or multiple physicians, practices are all trying to survive. How do we survive? What are the goals? Space. Some physicians have decided to return to a hospital setting because of the pressures and expense of running a private practice, while others are deciding whether starting a practice is financially feasible. Services. While physicians and managers are working together to stay in practice, they also are trying to decide if the practice could offer other services as added lines of revenue. Have they maximized the use of their service line? If they add services, can they be assured they will be reimbursed not only for the service, but for the time spent supplying these services? Supplies. If we add services, we are then faced with procuring supplies. We have to manage our costs by constantly “shopping.” This is only one of the many hats we wear as we strive to survive. Standards of care. We are facing all of these challenges, but we still stay the course and provide high-quality care. We, along with our physicians, struggle daily with answering the question, “What happened to the well-being of the patient?” All of the quality indicators associated with measuring performance seem to work at a high level. When we try to implement them at the physician level, however, it becomes somewhat complicated, and the focus sometimes veers away from the patient. Some of the information collected from these indicators is positive, some is not. All information is essential, though, for

patient-centered care laced with high quality. Everyone involved in the patient encounter strives for excellence. Support. We as managers are driven to support our physicians, our patients, and each other in the challenges we face. Perhaps we should align ourselves throughout our specialty in the development of tools, training, and information

Iris W. Nichols

By identifying goals, working side by side, and reaching out to industry partners to achieve these goals, we as a specialty will become stronger. We are all aware that there is strength in numbers; no one is an island. technology infrastructure. Support comes in the form of financial, professional, and educational assistance. There is a need for an elite group of people who are willing to serve as mentors for those who need some help as they learn the unique

April 2014

By speaking with one voice and partnering together at the practice, we can change the landscape. aspect of our specialty. Strengthen. By identifying goals, working side by side, and reaching out to industry partners to achieve these goals, we as a specialty will become stronger. We are all aware that there is strength in numbers; no one is an island. Strategic planning. We must have a strategic plan in order to survive. Our goals must be defined, and there must be direction in achieving these goals. Changes are happening rapidly. Patient expectations have changed, rules of operation have changed, and healthcare delivery options have increased. All of these factors cannot distract us from our first priority, which is the patient. Success. Reorganizing for success needs to be our primary goal. We talk about providing high-quality care in today’s market. Our physicians know what this looks like, and they have always been invested in improving the lives of patients with chronic, life-altering diseases. Their purpose has not changed, but the pathways by which their destination is reached have been drastically rerouted. By speaking with one voice and partnering together at the practice, state, and regional levels, we can change the landscape. The path may not be currently defined, but as Robert Frost said, “I took the one less traveled by, and that has made all the difference.” Each day we create new paths and look for direction; together we will make a difference. l

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Practice Administration

Team Stress: Controlling Its Impact on Your Bottom Line By Sandra Paton

he uncertainty of the current healthcare environment has become a cause of undue stress. Al though stress can have a positive impact on individuals and organizations, it most often wields a Sarah J. Holt, negative effect. Ac PhD, FACMPE cording to the American Institute of Stress (www. stress.org/workplace-stress/), up to 60% of absenteeism in the workplace has been attributed to stress. Downsizing, mergers, increased regulatory requirements, and increased work demands all contribute to workplace stress. Sarah J. Holt, PhD, FACMPE, administrator of Cape Girardeau Doctors’ Park, Cape Girardeau, MO, recently shared with practice managers the effect of stress on teams and the impact it has on the financial bottom line. Dr Holt began by distinguishing between challenges and stressors. Some people thrive on challenges. Whereas challenges may be appropriate to a person’s skill level, ability, and knowledge, stress may result when an employee does not have the resources or skills to accomplish a task they have been given. Certainly, people react differently to stress, based on their personalities and emotional intelligence. There are, however, certain traits that are conducive to stress. Conscientious employees, she noted, are at one end of the spectrum, while disorganized employees are at the other end. Those plagued by perfectionism can never get anything done, because they seek to

attain the often unattainable. Emotionally stable employees are often levelheaded and resilient. They might be cool in the face of stress, while anxious, fidgety employees prove fragile. Others might have to walk on eggshells around them. Most of us, she explained, are somewhere in the middle, and once in a while fall out of balance. People who are open are adaptable to change and welcome it. They rally in finding new ways to do things and seek the “better way.” They are apt to be creative and curious. Others are fearful. The slightest change upsets them and sends them into retreat.

Although stress can have a positive impact on individuals and organizations, it most often wields a negative effect. Some employees are agreeable. Others are disagreeable. Although practices might hope that everyone in their employ is 100% agreeable, they would find that these employees are of little value. If a colleague agrees with everything you suggest, you might as well be in an echo chamber. Dr Holt noted that there is no value in exchanges with overly agreeable colleagues. On the other hand, the colleague who is disagreeable for the sake of being disagreeable can become a serious annoyance and someone you would seek to avoid. “What we need on the agreeable spectrum is something closer to

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the middle. We want somebody with enough conviction to say, ‘Can we think about that for a minute? Can we discuss it?’ Because if they can’t and won’t, they will never serve as assets to your team,” she observed. Introversion and extroversion are other traits that you need to distinguish. Introverts might have excellent ideas, but might require that you draw ideas from them. “The truth is, the more you know about each person on your team, the more able you will be to create a successful, high-functioning team,” Dr Holt offered. All of the traits mentioned are likely to be found in some members of your team.

Stressors When asked to identify specific stressors at work, employees mentioned tension with coworkers, excessive work overload, role conflict, bad task design, and management style. “The number one reason why people leave organizations is bad management,” Dr Holt noted. “Good employees seek good management. When faced with bad management, it stresses them to the point where they cannot take it anymore and often leave the organization.” Other negative stressors include lack of support, lack of authority for work roles, lack of direction, career concerns, unpleasant physical working conditions, impossible deadlines, demeaning colleagues, and being on call 24/7. When an employee feels they are not getting sufficient support from their coworkers or their supervisors, they feel underappreciated. When workers are given broad responsibilities without sufficient authority to achieve those tasks, their burdens increase. Not knowing what to do and not being supported

Practice Administration

in a decision can cause tension. Do I follow the needs of the organization? What is best for the patient? Should I do this to make more money? Sometimes we have to struggle to figure out what to do, Dr Holt noted. Career concerns might arise when someone realizes there is no room for advancement in an organization. Other issues arise from unpleasant working conditions, such as being stuck in a cubicle with no windows. Impossible deadlines are another real problem. A colleague who took work home and stayed up all night to get a task done might feel underappreciated when their work was met without appropriate approbation. Demeaning and abusive colleagues can create a hostile work environment. It is important to pay attention and be alert to situations where abuse is not readily apparent. “Some abuse occurs on a subtle level. One should do everything possible to prevent abusive behavior and potential lawsuits that might arise from it,” Dr Holt said. Being unable to unplug from work is a huge problem. “Getting a call from the office at night while at home sends a message to your family that they come in second. This creates stress for you and your family,” Dr Holt warned. Related issues occur when you are continually tired and complain of being exhausted and unable to sleep. The next thing you notice is that you function below par and just do not care anymore. Be aware that burnout is imminent. Arbitrary management decisions that do not make apparent sense are often difficult to complete. When a seemingly senseless edict comes down, workers might ask: • “What is this all about?” • “Who decided this?” • “Why were we cut out of the loop?” • “Why didn’t we have some say in this decision?” Ever-rising expectations also add

an undue amount of stress. If the bar keeps getting higher and higher with less and less downtime, employees might have no opportunity to take a break or a breath before the next pile of work arrives. Stress often manifests physically, but sometimes also psychologically or behaviorally. These include sleeping problems, stomach upset, hypertension, depression, anxiety, cognitive difficulties, lack of judgment, inability to make decisions, disinterest, and isolation (eg, having lunch in the car and not with the group).

The Team A good team thinks, acts, and feels together. Members of a good team trust each other and perform like one—“just like a good family,” observed Dr Holt. Teams are essential, but they are also fragile. You might put together an excellent, high-functioning team, only to see it dissolve in an instant. Like all families, problems arise. “When teams are put under a tremendous amount of stress, they soon lose their focus on ‘we,’ and narrow their focus onto ‘I,’” she said. The thinking together stops, performance becomes independent, and the team deteriorates. Without the right leadership, the team will remain uncoordinated and cease productivity. When a team falls apart, management might feel the need to micromanage only to deteriorate the trust of team members further. “If you don’t trust me to get the work done, then I don’t trust you.” The US Bureau of Labor Statistics found that when employees leave work because of stress, they typically stay away from work for a period of 20 days. “Unfortunately, when 1 person vacates his or her desk, someone else must fill in. And someone else must fill in for them and so on down the line,” Dr Holt explained. She described how as many as 4 or 5 workers might be displaced, possibly

for a period of 20 days, preventing efficient operation.

Management Must Lead The fact of the matter is that “management has the authority and the responsibility to make things in the workplace function differently and well,” Dr Holt reminded the audience. One of the things management must do is “lead by example.” She urged managers to look on the bright side, look for things to be grateful about, and focus or refocus on team building. Although she noted that managers might not be able to change what is happening in the C-suite, they can change how their own department functions and reacts to it. Working together, bringing relief to each other, and renewing the focus on your team can make all the difference. “Strive to be a good leader. And strive to address problems in a way that will be seen as appropriate. This is a tough call,” Dr Holt noted, “but your efforts will be appreciated if you attempt to be genuine. Disingenuousness does not work.” Managers must be careful not to ignore the signs and symptoms of stress. And they might consider stress reduction programs, either formal or informal. Dr Holt recommended planting the seeds for instituting a stress reduction program in the future if having one now is not possible. Managers should attempt to clarify who is responsible for each operation and then hold that person accountable. “When a team member has not been accountable, the leader must step into the role—in private. This is how trust is built,” said Dr Holt. When trust is broken—and this will happen—the manager must make the effort to repair it. It will be important to realign your purpose, encourage professionalism, and develop an alternative course of action. Ultimately, you must manage yourself—possibly a lifelong goal. Dr Holt urged practice managers to Continued on page 13

April 2014

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Wealth Management

Your 401(k) Plan Stinks: 3 Ways to Make the Best of a Bad Situation By W. Ben Utley, CFP®; and Lawrence B. Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF

Lawrence B. Keller

W. Ben Utley

e see quite a few changes physicians might make to improve their financial security, but 1 item is usually beyond their control: the 401(k) plan. Un less you are self-employed, there is practically nothing you can do about your 401(k)’s underwhelming investment options, ridiculously low contribution limits, or perverse tax consequences. If your 401(k) is your main (or maybe your only) investment vehicle for retirement, we have good news for you: It is possible to work around your 401(k) plan’s limitations so you can get back on track toward retirement.

Low Limits Many physicians operate under the mistaken belief that, if they max out their 401(k) plan contributions, they will be all set for retirement. But did you know that the maximum amount of money you can elect to defer into your 401(k) this year is only $17,500 ($23,000 if you will be aged 50 years or older by December 31)? That’s roughly $1400 deducted from your paycheck each month ($1900 per month if you are aged 50 years or older). Have you ever met a physician who could live well on $1400 a month? We haven’t. In fact, the physicians we serve are planning to

spend more like $10,000 per month in retirement, and that’s after-tax. It would take a miraculously high rate of return to turn $1400 per month pre-tax into $10,000 per month after-tax, so many physicians are well on their way to a retirement disaster. To improve your odds of reaching your retirement goal, you can save outside your 401(k) plan. Even if you cannot deduct the contributions you make to a traditional IRA, you can still contribute $5500 this

Unless you are selfemployed, there is practically nothing you can do about your 401(k)’s underwhelming investment options.

year ($6500 if you will be aged 50 years or older by December 31), and if you max out your own IRA, your spouse can also contribute up to $5500 to his or her IRA ($6500 if he or she will be aged 50 years or older by December 31) even if he or she is not earning an income. Depending upon your tax situation, it might also make sense to convert these contributions to a Roth IRA, doing what is known as a “backdoor” Roth IRA contribution. Once the money is in a Roth IRA, it can grow tax-free for the rest of your life. Of course, this still might not be enough to allow you to retire comfortably, so you should consider investments outside of your 401(k) plan and IRAs.

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I April 2014

Underwhelming Options You probably haven’t read the fine print behind your 401(k) plan, but you are betting that your practice manager has carefully vetted both your 401(k) plan provider and the investments offered inside your plan. Don’t believe it! We have found that busy managers may lack the time or expertise to make well-informed decisions regarding investment-related fees or available investment options. If your plan charges more than 50 basis points (0.50%) on top of mutual fund operating expenses, your plan’s costs are draining an unfair share of your retirement savings. To get this under control, you need to raise your voice, but be careful. We regularly see very expensive plans that persist simply because of office politics. It’s more common to see an investment lineup consisting mostly, if not entirely, of actively managed mutual funds. This is a sign of ignorance on the part of your plan fiduciaries. At a time when most prudent investors recognize that passively managed index funds have been shown to have delivered better results at a lower cost than the average actively managed fund, there’s no good reason that your plan should continue to limit you to subpar investment options. To work around these issues, look at your retirement investments holistically. Think about your 401(k) plan, your traditional IRAs, and your after-tax accounts (mutual funds and brokerage accounts) as if they were all 1 “retirement portfolio.” Then use the least-bad investment options from your 401(k) and pair them with the best options available within other accounts that make up the balance of your portfolio.

Wealth Management

Tax Time Bomb You already know that physicians pay more than their fair share of taxes. But did you know that you are probably setting yourself up to pay more taxes on your 401(k) than you really should? That’s right. There’s a perverse little wrinkle in the tax code that can turn your 401(k) plan into a tax time bomb. To understand this trap, you need to know a little bit about how investments are taxed. Withdrawals from your 401(k) plan will be taxed at your marginal income tax rate, which may be as high as 39.6% for federal income tax. At the same time, capital gains and qualified dividends from mutual funds held in taxable accounts outside your 401(k) plan are taxed at a maximum federal rate of 23.8% (which is 20% plus the new 3.8% Medicare surtax). This means that your 401(k) nearly doubles the tax rate you pay on capital gains and qualified income by effectively converting these tax-favored returns into taxtrapped ordinary income. Consider holding equity mutual funds in a taxable account, or better yet, own them in your Roth IRA or the Roth subaccount of your 401(k), if you have one.

If your 401(k) is a lousy place to stash your stock funds, what should you hold there instead? Consider low-growth, income-producing in vest ments, including bond funds and stable value funds. If you have

Look at your retirement investments holistically. Think about your 401(k) plan, your traditional IRAs, and your aftertax accounts as if they were all 1 “retirement portfolio.” an appetite for more aggressive fare, consider high-yield (“junk”) bond funds or emerging market bond funds. Outside your 401(k) plan, these investments may be taxed at your highest marginal rate, so it’s a good idea to protect their income by keeping it inside the tax shelter of your 401(k) plan. Again, the best workaround for this tax trap is to view your entire retirement portfolio—including your

401(k) plan, your IRAs, and your other accounts that are earmarked for retirement—as 1 portfolio. Choose to own the best investments in the accounts that make the most sense from the standpoint of expense, risk, return, and taxation.

Conclusion Even if you are stuck with a stinky 401(k) plan, you can still make the best of a bad situation. All you have to do is take a look at the big picture, think outside the box, and make smart moves to put yourself on track for a solid retirement. l W. Ben Utley, CFP®, is the lead advisor with Physician Family Financial Advisors, a fee-only financial planning firm helping doctors throughout the United States to save for college and invest for retirement. Contact him at 541-4630899 or visit www.physicianfamily.com. Lawrence B. Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF, is the founder of Physician Financial Services, a New York–based firm specializing in income protection and wealth accumulation strategies for physicians. He can be reached at 800-481-6447 or by e-mail to Lkeller@physicianfinancialser vices.com with comments or questions.

Team Stress: Controlling Its Impact on…Continued from page 11 admit when they have made a mistake. “When you identify that there is a problem with the team, you must decide what the outcome should be. When you intervene, be intentional—determine whether you should coach, counsel, or discipline. But act promptly before a problem becomes too big or too intense.” In short: • Express gratitude • Celebrate small successes • Seek honest feedback • Define problems

• Attempt to learn the scope of stress • Implement interventions, where possible • Evaluate the interventions • Give your team a measure of freedom; it is OK to tweak the rules and change the goals. Dr Holt cautioned not to let your ego get involved: “Take 2 steps back and realize that this is not necessarily about you. It’s about the team and the organization—both are a whole

April 2014

lot bigger than you.” She urged attendees to use appropriate body language and to avoid lecturing. “Reconvene when you think the team has heard enough or has had enough. Your ultimate goal is to create a safe working environment. In the midst of a crisis, it is important to stay calm. Use humor to diffuse a tense situation. And don’t take yourself too seriously—remember, anything you do to elevate our profession, elevates us all.” l

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Medical Legal Update

The Cost of Using Free Images for Your Website By Caroline P. Wallitt, Esq; and Jennifer A. Kirschenbaum, Esq

racticing medicine is no long er exclusively characterized as providing patient care. A physician is now re quired to be a skilled clinician, a marketing guru, an entrepre neur, an accountant, and a legal savant, Jennifer A. given the level of Kirschenbaum financial hurdles and oversight that are required to run a successful practice today. With the advent of digital media marketing, a physician must also now add “web designer” to his or her skill set. While private practitioners and institutions may have little in common in the way of operations, a common factor between them is that each seemingly must have a website or other online presence in order to compete in today’s marketplace. Whether this task is tackled by senior management or is delegated to a hired intern, many physicians are involved, at least to some extent, in their website development and the creation and posting of marketing content. Understandably, strictly sticking to substance often results in a dull website, which could potentially hamper ongoing marketing efforts and the original intended result of the marketing in the first place— to increase patient flow. To entice potential patients and referral sources, many practices seek to create website content with character, using images to add color and points of interest to the presentation. However, an often-overlooked consideration is whether the images that are chosen for a website are protected intellectual property, and whether their use without permission could lead to potential exposure for an unaware user.

Empowered by recent court decisions, image owners are increasingly filing claims for copyright infringement. Under the law, anyone who violates any of the exclusive rights of a copyright owner has committed copyright infringement. The law does not require that the defendant commit the infringement willfully—the infringing act itself is enough to impose liability, meaning that a company that unknowing-

The infringing act itself is enough to impose liability, meaning that a company that unknowingly uses copyrighted images without the owner’s permission can be held liable for infringement. ly uses copyrighted images without the owner’s permission can be held liable for infringement. As for damages, an infringer is liable for either: (1) the copyright owner’s actual damages and any additional profits of the infringer; or (2) statutory damages, which can be adjusted upward or downward based on the infringer’s culpability, or level of willfulness. Copyright owners often opt to sue for statutory damages, available only in limited circumstances, when the actual damages and additional profits are difficult to calculate. As an example, in October 2013, a jury awarded microscopic photographer Andrew Paul Leonard

$1.6 million in actual damages for his copyright infringement claims against Stemtech International, Inc, a manufacturer of nutritional supplements that are sold through a network of more than 40,000 independent distributors (Andrew Paul Leonard v. Stemtech Health Sciences, Inc [C.A. No. 08-067-LPS-CJB]). Stemtech made the fateful mistake of copying 2 images—without Leonard’s permission—for use in all of its promotional materials, including brochures, videos, DVDs, and websites. Stemtech was aware that it was using copyrighted images, because it had previously paid Leonard annual licensing fees for the use of his images. From the facts that could be gleaned from the court docket as of this writing, with the official trial transcript set to be publicly released early this year, this unique case epitomizes the worst-case scenario for a company that copies online images for its own use without obtaining the proper permission to use them. The jury concluded that Stemtech was liable not only for its own direct copyright infringement, but it was also liable for the vicarious and contributory copyright infringement for all of its independent distributors who had also used Leonard’s images in their marketing materials, which contributed exponentially to Stemtech’s monetary exposure. Because Stemtech’s marketing policies require that its independent distributors use only its replicated website and marketing materials to market or sell its products, Stemtech ended up using each copyrighted image abundantly for multiple years. Another factor that caused the actual damages to skyrocket was the jury’s likely acceptance of the $1500 fair market Continued on page 18

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Invitation to Join the RPM Editorial Board The publishers of Rheumatology Practice Management™ (RPM) are inviting qualified rheumatology practice owners and administrators to participate as members of the RPM Editorial Board. As an Editorial Board member, you will play an active role in helping to shape the content of this exciting new publication. Rheumatology Practice Management is a niche publication focused on process solutions for rheumatology practices. RPM is designed to provide the rheumatology care team—medical, practice administrators, coders, and billers—with the knowledge and skills required to keep abreast of today’s fast-changing business environment, allowing practice professionals more time to concentrate on high-quality patient care. Each issue of RPM will focus on various areas of rheumatology practice, featuring current topics such as: • Healthcare technology • Models of care • Staffing • Reimbursement and coding • Drug updates

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By Jennife r Kirschenba um, Esq t should be ™ medical pra no surprise to read tha ctic maintain pro es have an obligation t Notification Rul e to You tect ed health info in certain may not be (45 CFR Part 164 rmation ways, and ). By Phoeb awa re of to only use Notification close such e Starr and pro Rule becaus the Breach as authorized tected health informa dis- of proposed e it was New Orl mo part ean by law. Suc by the patient or oth tion eral years ago difications set forth online too s, LA—An interac severw h , l tive, under the Priv requirements are set ise not adopt the and many practices patients wit shows promise in hel did forth bec requiremen h rheumato acy Rule. ping ause the stat ts self-manag What you id arthritis e their pain may be surp (RA) ute at that of the rule bee tha n time had not to be a use rised to read and could written wit t when pro ful adjunct pro h teeth. is not mai tected health informa is However, to office visi ve this patien the nta t pop ts tice in acc ined by a medical tion on January 25, Final Rule promulgat poster presen ulation, according for ordance wit 201 prac- Bre ed to a fication to h HIPAA ach Notificati 3, not only modifies Pain Society ted at the 2013 Am , the patien eric t or other noti- significant enfo on Rule, it incorpo the may be req of investigato annual meeting by a an sou rates uired pursua rcement pro team nt to the Brerces a breach occ MA. They rs from Inflexxion, New ur and not visions should ach presented be dealt with findings fromton, interventio n called an Continued on pain online pro page 10 gram for the ACTION, an of patients self-manag ement with pain rheumatic associated By Susann disease. with e Talebian Participan , CUA, CP Certified ts He C, CUC, improved out in this program CCS-P, CM Managem althcare Business Co OM had ent Assoc ness about comes in pain relief, iation–Ce nsultant, American , PCS, RMM awa the rtified ICD agement beh ir condition, and self re-10-CM/PC Health Information n October -manaviors, as wel S Trainer 1, 2014, the mood and l as improv States will Un coping skil ited ed ado ls and better of life compar Classification pt the International and Phase 4: Postimplem qua ed lity wit quarter 201 h controls of Disease Revision, Clin ilar level of with a sims, Tenth 4 through fou entation, fourth RA pain at ical Mo rth quarter dification/P Coding Sys baseline. “These imp roce 2015. tem reprieve, alth (ICD-10-CM/PCS) dure Phase 1: Im pain self-effi rovements in partici . pact Asses pants’ cacy, pain less than 16 ough welcome to man The You coping thro sment months awa y, is com r practice should ugh relaxat catastrophizing, several pha ion, and qua life indicat ses of implem y, during which are pleted the impact asse already have e that pain lity of AC com ent ssm beh important ation must pleted. The ent. If you element of TION can be an be hard ind schedule, you timeline ing the cod a comprehen disease man e sets is div for implement- Inte now to catch up. need to work age sive ided into 4 The shift Phase 1: Imp rnational with arthritis ment program for pha from Cla people pain. Furthe ter 2009 throact Assessment, first ses: Ninth Revision ssification of Disease needed to r research quar- cha (ICD-9) inv s, determine is Phase 2: Pre ugh second quarter llenges, inc which sub olv es serious 2012; syst lud groups first quarter paring for Implement em of 13,000 ing transitioning from Continued on ation, tha 2012 through a codes to a syst page 8 2014; Phase n 68,0 seco em 00 nd of codes in ICD more quarter 3: Go Live In partners -10-CM. quarter 201 You may Preparation, hip with recall that 3 through third quarter first tation of a the new generat implemen2014; ion of the Nat iona l O r gan izat 9 Cont R heu ion

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Medical Legal Update

The Cost of Using Free Images...Continued from page 16 value rate for Leonard’s licensing fee, rather than the average licensing fees of approximately $125 and approximately $226 for each of the 2 respective images that were actually charged by Leonard during the relevant time period. It should be noted, however, that Leonard v. Stemtech is still not over; the 2 parties are currently briefing postjudgment issues and there is always the prospect of an appeal. Granted, it is unlikely that another company would be liable for the $1 million-plus in damages that the jury awarded Leonard without achieving the perfect storm of damage variables—a high fair market value licensing fee, numerous instances of infringement resulting from the distributors’ use of the images in their own marketing materials, multiple years of violations, and actual knowledge of the infringing activity. A more probable scenario is a medical practice procuring an image from the Internet and using it for its own use on its website without the awareness or knowledge of whether that image is copyrighted. Under such circumstances, it is not unusual for such activity to result in a demand for money for copyright infringement now that copyright creators (and hungry collection agencies as well as plaintiffs’ attorneys) are able to use “web crawlers” to identify copyrighted images that are being used without permission. In fact, some companies use these tactics to generate “robo letters” on behalf of copyright owners for collection purposes, sending demands for payment to alleged copyright infringers en masse. (In the web community, Getty Images is notorious for this practice.) It is also not unusual for such demand letters to cite copyright infringement as justification for extortion, claiming entitlement to excessive fees in exchange for ward-

ing off the threat of legal action. Many times, the recipient of a copyright infringement demand letter is the unknowing business owner who is guilty of nothing more than haphazardly selecting images from the Internet to create a more

Further mitigating any potential exposure, this time for actual damages, is whether the image is used for the economic benefit of the user, and whether any profit may be tied to the image’s use. appealing web presence. In many instances, the selected images may not contain the mandatory statutory notifier, or the copyright mark (©), which could possibly mitigate the potential exposure for statutory damages because the image is not clearly identified as protected intellectual property. Further mitigating any potential exposure, this time for actual damages, is whether the image is used for the economic benefit of the user, and whether any profit may be tied to the image’s use, as was the case in Leonard, where the images were tied to profit because they were prominently displayed on marketing materials. Depending on the circumstances surrounding the use of a protected image, any potential exposure for the misuse of such an image may range from very minimal to somewhat defensible, as it was in Leonard.

RHEUMATology Practice Management

I April 2014

The recommended best practices that can help to avoid copyright infringement exposure entirely include either avoiding the use of copyrighted material or securing the proper licensing rights to the copyrighted material before using it. Many professionals outsource their content creation or content management, so before engaging a third party to perform such services, it is important to inquire whether the company invests in protective measures to avoid the misuse of copyrighted content, and, when possible, incorporate indemnity protection into your vendor contract with the third party against any misuse that may occur as a result of its efforts. Additionally, should you find yourself in receipt of a demand letter alleging the misuse of copyrighted material, do not send a check without contacting an attorney and performing proper due diligence regarding the claim. For a review of any contract with a third party that is responsible for content creation or management on your behalf, or for assistance/defense of any claim of copyright infringement, contact Caroline or Jennifer to discuss your options. l Caroline P. Wallitt, Esq, is a partner of Kirschenbaum & Kirschenbaum, P.C., and specializes in representing clients, especially those in the healthcare sector, in litigation, arbitration, mediation, and prelitigation disputes. She may be reached at 516-747-6700, x305, or by e-mail at CWallitt@kirschenbaum esq.com. Jennifer A. Kirschenbaum, Esq, is a partner of Kirschenbaum & Kirschenbaum, P.C., and specializes in representing healthcare clients in transactional, regulatory compliance, and general practice matters. She may be reached at 516-747-6700, x302, or by e-mail at JKirschenbaum@kirschenbaumesq.com.

Drug Update

Simponi Aria (Golimumab): A New Intravenous

TNF Inhibitor for Patients with Rheumatoid Arthritis By Loretta Fala, Medical Writer

heumatoid arthritis (RA), a chronic inflammatory autoimmune disorder that affects the lining, or synovium, of the joints, affects 1.3 million people in the United States.1,2 In addition to causing painful swelling that may eventually lead to bone erosion and joint deformity, RA can also affect other organs of the body, including the skin, eyes, lungs, and blood vessels.1,2 Although RA can occur in people in their 20s and 30s, it usually begins after age 40, affecting more than twice as many women as men.1,2 The average age of patients with RA is 66.8 years.2 In its early stage, RA may first affect smaller joints (ie, those that attach the fingers and toes), and as the disease progresses, it spreads to the knees, ankles, elbows, hips, and shoulders.1 An estimated 22% of all deaths from arthritis and other rheumatic conditions are attributed to RA.3 Aside from being associated with a high risk of disability and mortality, people with RA are twice as likely to die as persons of the same age without RA.3 Approximately 40% of all deaths associated with RA are attributed to cardiovascular causes, including ischemic heart disease and stroke.3 RA also has a substantial impact on a patient’s functional status and quality of life. One study showed that people with RA were 40% more likely to report fair or poor general health and twice as likely to have a healthrelated physical activity limitation.3,4 RA is also associated with substantial costs. According to one study, RA accounted for $19.3 billion (2005 dollars) in societal costs excluding intangible costs, and $39.2 billion including intangible costs (ie, consequences of RA).5 The management of patients with RA is aimed at reducing joint pain

and swelling, alleviating stiffness, and preventing joint damage.2 According to the 2012 American College of Rheumatology (ACR) recommendations for the use of disease-modifying antirheumatic drugs (DMARDs) and biologic agents, including tumor necrosis factor (TNF) blockers, in the treatment of RA, “The goal for each RA patient should be low disease activity or remission. In ideal circumstances, RA remission should be the target of therapy, but in others, low disease activity may be an acceptable target,” the authors of the updated guidelines state.6 The ACR recommendations also state that decisions about treating to target are left to the clinician who is caring for the individual patient, based on the patient’s preferences, comorbid conditions, and other relevant factors. Moreover, treatment plans involve patient-tailored risk- benefit analysis based on the clinician’s assessment and collaboration with the patient.6 The nonpharmacologic treatment of RA generally includes a combination of joint protection, the use of heat or cold to reduce pain, and physical or occupational therapy.2 Other self-management approaches include maintaining a healthy body weight and performing physical activity as appropriate, depending on the patient’s level of physical mobility.2 Because joint damage caused by RA occurs early, generally within the first 2 years of disease onset, it is vital that RA be diagnosed and treated early.1,2 The ACR panel recommended more aggressive treatment in early RA in the 2012 update than in the previous 2008 recommendations, most likely based on the potential for better outcomes, prevention of irreversible joint damage, preservation of physical function and

health-related quality of life, and reduced work-related disability.6

Simponi Aria: A New Option for RA In July 2013, the US Food and Drug Administration (FDA) approved golimumab for infusion (Simponi Aria; Janssen Biotech), a TNF inhibitor, for the treatment of moderate-to-severe RA in combination with methotrexate.7 Golimumab (Simponi) injection for subcutaneous use was previously approved by the FDA in 2009 for moderately to severely active RA in combination with methotrexate.7,8 In May 2013, golimumab for subcutaneous use received a new indication from the FDA for the treatment of ulcerative colitis that is resistant to previous treatment or requires continuous steroid therapy.9 According to John Hardin, MD, Director of Osteoarthritis at the Arthritis Foundation in Atlanta, and Professor of Medicine at Albert Einstein College of Medicine in the Bronx, NY, the availability of golimumab IV allows for its administration at an infusion center, which ensures that the patient is receiving the appropriate dose, because patient self-injection techniques may vary.7 Dr Hardin commented, “Logistically, it’s easier in some cases with IV infusions.”7 Mechanism of Action Golimumab, a TNF blocker, is a human monoclonal antibody that binds to the soluble and the transmembrane bioactive forms of human TNF-alpha to its receptors. This interaction prevents the binding of TNF-alpha to its receptors, thereby inhibiting the biological activity of TNF-alpha (a cytokine protein).10 Elevated TNF-alpha levels in the blood, synovia, and joints have been Continued on page 20

April 2014

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Drug Update

Simponi Aria (Golimumab)...Continued from page 19 implicated in the pathophysiology of RA. TNF-alpha is an important mediator of the articular inflammation that is characteristic of RA.10

Dosing The recommended dose of golimumab IV for patients with moderate-to-severe RA is 2 mg/kg as an IV infusion over 30 minutes at weeks 0 and 4, and then every 8 weeks. The dilution of supplied golimumab IV solution with 0.9% weight/volume sodium chloride is required before administration. Golimumab IV should be given in combination with methotrexate. Other nonbiologic DMARDs, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), and/or analgesics may be continued during treatment with golimumab IV.10 Phase 3 Trial: GO-FURTHER The FDA approval of the new indication for golimumab IV was based

on the randomized, double-blind, phase 3, placebo-controlled trial known as GO-FURTHER, which included 592 patients (aged ≥18 years) with moderately to severely active RA despite concurrent treatment with methotrexate who had not previously received a biologic TNF blocker. Patients were randomized to either go limumab IV 2 mg/kg (N = 395) or to placebo (N = 197) over a 30-minute IV infusion at weeks 0, 4, and every 8 weeks thereafter in addition to their weekly maintenance dose of methotrexate (15-25 mg/kg).10,11 All patients who were initially receiving placebo plus methotrexate in the trial received golimumab IV plus methotrexate after week 24; however, the trial remained blinded until all patients had completed 52 weeks of treatment. Efficacy data were collected and analyzed through week 52. Patients were allowed to continue receiving stable doses of concomitant

Table 1. Proportion of Patients with an ACR Response: Golimumab IV plus Methotrexate versus Placebo plus Methotrexate in the GO-FURTHER Trial Active RA, despite methotrexate treatment Placebo + Golimumab IV + 95% methotrexate, % methotrexate, % confidence (N = 197)a (N = 395)a intervalb ACR20 Week 14

25.9-41.4

Week 24

23.3-39.4

Week 14

15.3-27.2

Week 24

15.1-28.4

Week 14

5.3-13.4

Week 24

8.8-18.1

ACR50

ACR70

N reflects randomized patients. For difference in proportions. ACR indicates American College of Rheumatology; ACR20, ACR 20% improvement response criteria; ACR50, ACR 50% improvement response criteria; ACR70, ACR 70% improvement response criteria; IV, intravenous; RA, rheumatoid arthritis. Source: Simponi Aria (golimumab) injection prescribing information; 2013. a

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low-dose corticosteroids (equal to ≤10 mg of prednisone daily) and/or NSAIDs, and patients might have received oral methotrexate during the trial. The use of other DMARDs, including cytotoxic agents or other biologics, was prohibited.10 The primary end point in this trial was the percentage of patients who achieved an American College of Rheumatology (ACR)20 response at week 14.9 ACR20 is defined by the ACR as a 20% improvement in tender and swollen joint counts and a 20% improvement in at least 3 of the 5 remaining ACR core set measures—patient global assessment, physician global assessment, pain, disability, and an acute-phase reactant.12 ACR50 represents a 50% improvement in these measures, and ACR70 represents a 70% improvement.12 A total of 58.5% of the patients in the golimumab IV plus methotrexate group achieved a 20% improvement in their ACR20 score at week 14 compared with 24.9% (49:197) of the patients in the placebo plus methotrexate group (P <.001).7,11 Moreover, a larger proportion of patients treated with golimumab IV plus methotrexate had a disease activity score (DAS) of a good or moderate (European League Against Rheumatism) response (81% vs 40%, respectively), and a greater median improvement in health assessment questionnaire scores (0.5 vs 0.125, respectively) versus placebo plus methotrexate (P <.001). Table 1 shows that a greater percentage of patients in the active arm achieved ACR20 at week 14 and ACR50 at week 24 than patients in the placebo arm.10 In all components of the ACR response criteria, improvement was either equal among the 2 groups or was greater in the golimumab IV plus methotrexate group than in the placebo plus methotrexate group

Drug Update

(Table 2). In addition, at week 14, a greater proportion of patients who received golimumab IV plus methotrexate (15%) achieved a low level of disease activity, as measured by a DAS28 using C-reactive protein (DAS28-CRP) score of <2.6 compared with patients treated with placebo plus methotrexate (5%; 95% confidence interval, 6.3%-15.5% for the difference).10 The DAS28-CRP is an index of disease activity for the 28 joints that are frequently affected by RA based on CRP levels.13

Adverse Events The most common adverse reactions (incidence >3%) are upper respiratory tract infection, viral infection, bronchitis, hypertension, and rash.10 Golimumab contains a boxed warning about serious infections and malignancy. Serious infections that can lead to hospitalization or to death, including tuberculosis, bacterial sepsis, and invasive fungal (ie, histoplasmosis) and other opportunistic infections have occurred in patients receiving golimumab. Therapy with golimu mab should not be started during an active infection. If an infection develops, the patient should be monitored carefully and golimumab treatment should be stopped if the infection becomes serious. Patients should be tested for latent tuberculosis before the initiation of golimumab therapy. If the tuberculosis test is positive, treatment should be started for tuberculosis before initiating golimumab. Patients should be monitored for active tuberculosis during treatment, even if the initial latent tuberculosis test is negative. Lymphoma and other malignancies, some fatal, have been reported in children and in adolescent patients who were treated with TNF blockers, of which golimumab is a member.10 Warnings and Precautions Invasive fungal infections. For patients who develop a systemic ill-

Table 2. Components of ACR Response at Week 14: Golimumab IV plus Methotrexate versus Placebo plus Methotrexate in the GO-FURTHER Trial Active RA, despite methotrexate treatment Placebo + methotrexate (N = 197)a

Golimumab IV + methotrexate (N = 395)a

Baseline

Week 14

Baseline

Week 14

Baseline

6.5

Week 14

5.6

3.9

Swollen joints, N (0-66)

Tender joints, N (0-68)

Patient’s assessment of pain (0-10)

Patient’s global assessment of disease activity (0-10) Baseline

6.5

Week 14

5.5

4.0

Physician’s global assessment of disease activity (0-10) Baseline

6.3

6.2

Week 14

4.9

3.1

Baseline

1.6

Week 14

1.4

1.1

Baseline

2.2

2.8

Week 14

1.8

0.9

HAQ score (0-3)

CRP, mg/dL (0-1)

N reflects randomized patients; actual number of patients evaluable for each end point may vary. NOTE: All values are means. ACR indicates American College of Rheumatology; CRP, C-reactive protein; HAQ, health assessment questionnaire; IV, intravenous; RA, rheumatoid arthritis. Source: Simponi Aria (golimumab) injection prescribing information; 2013.

ness while taking golimumab IV, empiric antifungal therapy should be considered for those who live in or travel to regions where mycoses are endemic.10 Hepatitis B reactivation. Hepatitis B virus carriers should be monitored during and several months after therapy. If reactivation occurs, golimumab should be discontinued and antiviral therapy should be initiated.10 Malignancies. More cases of lym-

phoma have been observed among patients receiving TNF blockers compared with patients in the control groups. Cases of other malignancies have been observed among patients receiving TNF blockers.10 Heart failure. The worsening or new onset of heart failure may occur with golimumab. If worsening symptoms occur, the use of golimumab should be stopped.10 Demyelinating diseases. The exContinued on page 22

April 2014

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Drug Update

Simponi Aria (Golimumab)...Continued from page 21 acerbation or new onset of demyelin ating diseases may occur with golimumab.10 Hypersensitivity reactions. Serious systemic hypersensitivity reactions, including anaphylaxis, may occur with golimumab.10 Switching between DMARDs. Care should be taken when switching from one biologic agent to another biologic agent, because overlapping biologic activity may further increase the risk of infection.10 Hematologic cytopenias. In postmarketing reports, pancytopenia, leukopenia, neutropenia, aplastic anemia, and thrombocytopenia have occurred in patients receiving TNF blockers. In clinical studies, cases of pancyto penia, leukopenia, neutropenia, and thrombocytopenia have occurred in patients treated with golimu mab IV. Caution should be exercised when using TNF blockers, including golimumab IV, in patients who have or have had significant cytopenias.10

Drug Interactions Abatacept. In controlled trials, the concurrent administration of another TNF blocker and abatacept, a selective T-cell costimulation modulator, was associated with a greater proportion of serious infections than the use of a TNF blocker alone. The combination therapy, compared with the use of a TNF blocker alone, has not demonstrated improved clinical benefit in the treatment of RA. The combination of TNF blockers, including golimumab IV, and abatacept is therefore not recommended.10 Anakinra. The concurrent administration of anakinra, an interleukin-1 antagonist, and another TNF blocker, was associated with a greater portion of serious infections and neutropenia but with no additional benefit compared with the TNF blocker alone. The combination of anakinra with TNF blockers, including golimumab

IV, is therefore not recommended.10 Live vaccines. Live vaccines should not be given concurrently with golimumab.10

Use in Specific Populations Pregnancy. There are no adequate and well-controlled trials of golimumab in pregnant women. Golimumab should be used during pregnancy only if clearly needed.10 Nursing mothers. It is unknown whether golimumab is excreted in human milk or is absorbed systemically after ingestion. Because many drugs are excreted in human milk and there is a potential for adverse reactions in nursing infants from golimumab, consideration should be given as to whether to discontinue nursing or to discontinue golimu mab, taking into account the importance of the drug to the mother.10 Pediatric use. The safety and effectiveness of golimumab in pediatric patients aged <18 years have not been established.10 Geriatric use. With respect to RA, there were no overall differences in serious adverse events, serious infections, and adverse events in golimumab-treated patients aged ≥65 years (N = 155) compared with younger golimumab-treated patients. Because there is usually a higher incidence of infections in the geriatric population in general, caution should be used in treating geriatric patients with golimumab.10 Conclusion The approval of golimumab IV by the FDA in July 2013 for the treatment of moderate-to- severe RA in combination with methotrexate adds a new TNF inhibitor to the treatment options of patients with this chronic and debilitating disease. An earlier, subcutaneous version of go limumab subcutaneous injection had been approved by the FDA in 2009

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for moderately to severely active RA in combination with methotrexate. The IV route means in-office administration of the medication, which can be an advantage in cases where patient adherence is problematic, which can greatly affect outcomes. The safety and efficacy of golimu mab IV were assessed in the GO-FURTHER randomized, double-blind, placebo-controlled trial in adults with moderate-to-severe RA with moderately to severely active RA despite concurrent methotrexate therapy. The improvements associated with golimu mab IV plus methotrexate, compared with placebo plus methotrexate, were observed by week 2. The most common adverse reactions occurring in >3% of patients using golimumab IV are upper respiratory tract infection, viral infection, bronchitis, hypertension, and rash. l

References

1. Mayo Clinic. Rheumatoid arthritis. July 27, 2013. www.mayo clinic.com/health/rheumatoid-arthritis/DS00020. Accessed July 31, 2013. 2. Arthritis Foundation. Rheumatoid arthritis fact sheet. 2008. www.arthritis.org/files/images/newsroom/media-kits/Rheumatoid_Arthritis_Fact_Sheet.pdf. Accessed July 31, 2013. 3. Centers for Disease Control and Prevention. Rheumatoid arthritis. Updated November 19, 2012. www.cdc.gov/arthritis/ basics/rheumatoid.htm. Accessed July 31, 2013. 4. Dominick KL, Ahern FM, Gold CH, Heller DA. Healthrelated quality of life among older adults with arthritis. Health Qual Life Outcomes. 2004;2:5. 5. Birnbaum H, Pike C, Kaufman R, et al. Societal cost of rheumatoid arthritis patients in the US. Curr Med Res Opin. 2010;26:77-90. 6. Singh JA, Furst DE, Bharat A, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken). 2012;64:625-639. 7. Brown T; Medscape News. FDA approves intravenous golimumab (Simponi Aria) for rheumatoid arthritis. Press release. July 18, 2013. www.medscape.com/viewarticle/807965. Accessed July 31, 2013. 8. Simponi (golimumab) injection [package insert]. Horsham, PA: Janssen Biotech, Inc; 2013. 9. US Food and Drug Administration. FDA approves Simponi to treat ulcerative colitis. Press release. May 15, 2013. Updated May 17, 2013. www.fda.gov/NewsEvents/Newsroom/PressAnnounce ments/ucm352383.htm. Accessed August 6, 2013. 10. Simponi Aria (golimumab) injection [prescribing information]. Horsham, PA: Janssen Biotech, Inc; 2013. 11. Weinblatt ME, Bingham CO 3rd, Mendelsohn AM, et al. Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with responses as early as week 2: results of the phase 3, randomised, multicentre, double-blind, placebo-controlled GO-FURTHER trial. Ann Rheum Dis. 2013;72:381-389. 12. Felson DT, Anderson JJ, Boers M, et al. American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995; 38:727-735. 13. Wells G, Becker JC, Teng J, et al. Validation of the 28-joint Disease Activity Score (DAS28) and European League Against Rheumatism response criteria based on C-reactive protein against disease progression in patients with rheumatoid arthritis, and comparison with the DAS28 based on erythrocyte sedimentation rate. Ann Rheum Dis. 2009;68:954-960.

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