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Volume 1 • Number 1

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Transitioning to ICD-10 “Welcome” to the By Susanne Talebian, CUA, CPC, CUC, CCS-P, CMOM, PCS, RMM Certified Healthcare Business Consultant, American Health Information Inaugural Issue of Management Association–Certified ICD-10-CM/PCS Trainer heu u m a t o l m o a g t y o Rheumatology l For Rheumatologists, nROctober o g y must be 1,t 2014, the United several phases of implementation a c i c R e a c tithecInternational a n e a States will adopt completed.

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ngage Healthcare Communications, LLC, the publishers of such titles as Oncology Practice Management, Urology Practice Management, and ValueBased Care in Rheumatology, is pleased to bring you the first issue of Rheumatology Practice Management, a niche publication that “connects the dots” between physicians and the people who run the medical practice—you, the practice manager or administrator.

As healthcare publishers, we understand that the demands of running a busy medical practice are only going to increase given the changing landscape of 21st-century healthcare in America.

With this new line extension of our very successful Practice Management franchise, we can now bring you, the rheumatology Continued on page 9

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Coding System (ICD-10-CM/PCS). The reprieve, although welcome to many, is less than 16 months away, during which

agem ent.com ter 2009 through second quarter 2012; Phase 2: Preparing for Implementation, first quarter 2012 through second quarter

Continued on page 20

A Journal Just for You

By Iris Nichols, President, National Organization of Rheumatology Managers; Editor-in-Chief, Rheumatology Practice Management

I

t is an exciting time for rheumatology practice managers when the National Organiza­ tion of Rheumatology Managers (NORM) and Engage Healthcare Communications, LLC, begin a partnership to launch a publication designed exclusively for those of us who are responsible for running a rheumatology practice. Going forward, each issue of Rheumatology Practice Management will include timely, valuable information

on such topics as office processes, billing, coding, information technology (IT), and the many ways we can manage our medical businesses as efficiently as possible.

Information Transfer What is the correct information, the most needed information, and how does Continued on page 3 In partnership with

In partnership with

National O r ganizat ion of o R heumatolo g y Man a ge rs

Nat ion a l O r ga n iz at ion of o R he u m atolo g y Man a gers From the publishers of

©2013 Engage Healthcare Communications, LLC

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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Engaging Patients in Pain Man ag an Importa ement nt Strategy for Rheum atology Practices

Take advantage of this unique opportunity to help your peers and enhance your professional reputation by becoming the newest member of the RPM Editorial Board. an affiliate of

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By Phoeb aware of to only use Notification close such e Starr and pro Rule becaus the Breach as authorized tected health informa dis- of proposed New Orl modifications e it was part eans, LA tion by the patien eral —A by law. Suc set forth sev online too h requiremen t or otherwise not years ago, and man l shows pro n interactive, y practices under the Priv patients wit adopt the ts are set mise in hel did forth bec req h rheumato acy Rule. ping ause the stat uirements of the self-manag What you id arthritis e their pain (RA) been written ute at that time had rule that when may be surprised to to be a use and could read is with teeth. protected not ful adjunct prove health info is not mai However, to office visi this patien rma 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 sources rates uired pursua rcement pro team rs from a Infl brea nt visi MA. They exxion, New to the Bre ch occur ach presented and not be ons should ton , findings from interventio dealt with 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 cop ed adopt the Inte United and Pha of life compar ing skills and better se Cla 4: rna Pos ssifi tional qua qua Revision, Clin cation of Diseases, rter 2014 thro timplementation, fou ilar level of ed with controls with lity Ten rth a simRA ugh fourth Coding Sys ical Modification/Proce th quarter 201 “These imp pain at baseline. tem dur 5. e Phase reprieve, alth (ICD-10-CM/PCS) pain self-effi rovements in partici 1: Impa . pants’ cacy, pain less than 16 ough welcome to man The Your practic ct Assessment coping thro months awa y, e ugh relaxat catastrophizing, is sho uld com 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 completed. entation mu ssment. If behind sch important The timelin you edule, you st be har element of TION can be an ing the cod e d 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 (IC determine ugh D-9 is seco ) involves seri s, Phase 2: Pre nd quarter llenges, inc which sub ous 2012; syst lud groups first quarter paring for Implement em of 13,000 ing transitioning from Continued on ation, tha 2012 through page 8 2014; Phase n 68,000 cod codes to a system of mo a 3: Go Live second quarter re es in ICD-10 In partners quarter 201 You may Preparation, hip with -CM. recall that 3 through third quarter first tation of a the implem new generat en2014; ion of the Nat iona l O r gan izat 9 Continue R heu ion

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For consideration to become an Editorial Board member, please complete the form below and fax to 732-992-1881 or e-mail to lneuman@the-lynx-group.com _______________________________________________________________________________________ First Name

Last Name

Credentials

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Rheumatology Practice Management™ 1249 South River Road, Suite 202A, Cranbury, NJ 08512

From the Editor

A Journal Just for You... Continued from page 1 this information find you? While we have excellent ideas for this publication, we do not know absolutely everything about what information you, the reader, needs, so we are asking for your help. I know, you must be thinking, “How can I put one more thing on my plate?” or find any time that is not already committed? I find myself feeling the very same way. My desire is for this magazine to be used as a true resource for your rheumatology business. Just as the journal ValueBased Care in Rheumatology contains pertinent information for the physicians, we want Rheumatology Practice Management to contain pertinent information for us. We want to be able to combine clinical knowledge and claims data, coupled with our IT department’s knowledge, to help all of us manage our risk and bring value to our practices.

Managers are the backbone of rheumatology practices. You, as the practice manager, are in a position of influence. You are tasked with providing the strongest infrastructure possible that will allow your physicians to care for their patients in the most efficient way possible while delivering the “gold standard” of medical care. We all know that the very best way to ensure that this infrastructure is strong is through talking with each other and sharing “best practice” standards. As we create and maintain this infrastructure, we must stay on top of healthcare trends by using tools that

help us to tighten our budgets and to strengthen our processes without compromising efficiency. How do we manage all of this and maintain our bottom line? Our jobs are more challenging today than ever before.

My image of this publication is to be a unique conduit by which we can share these standards, ideas, and tools. Practice managers and administrators have a wealth of information that comes from hands-on experience. What better resources to tap into for assistance, ideas, and directions for running a well-rounded practice? I hope to see the names and contact information from our members as we ask you to contribute to the success of this journal.

Through combined efforts, we as leaders will learn how to operate under the new laws and regulations imposed through the ever-changing healthcare environment. Although change in the healthcare environment is not an easy task, we know that working together will make the process easier.

We are excited about the partnership between NORM and Engage Healthcare Communications. How­ ever, the most important element of this partnership is you, the reader. We would like to hear from you. What are the challenges you face? Some of these challenges could include EHR, meaningful use, physician compensation, HIPAA issues, OSHA issues, contracts with payers, quality measures, the transition to ICD-10, Medicare reimbursement

issues, healthcare exchanges, and rising operating costs. It is daunting to think about all of these challenges.

In the article “Medical Practice Today,” which was published in the July 2013 edition of MGMA Connexion, Heather Grimshaw stated, “Resilience is a word that comes to mind when you look at the challenges faced by medical group managers, who grapple with regular small business issues, such as economic uncertainty, operational changes and staffing, in addition to rigorous government regulations, an industry overhaul and—most importantly—a responsibility to create environments that support patient health.” I have heard it said that healthcare is the only industry where we are mandated to deliver a stellar product without knowing what the rules are. We do not know from one minute to the next what—or if—we are going to get reimbursed, yet we are to maintain business as usual. We have chosen to be in the healthcare field, and, therefore, we will meet the challenging days ahead.

Collaboration with all partners will move us forward as we strive to provide insight into process improvements to enhance patient care. No one should have to reinvent the wheel. Someone who is much smarter than I has a patent on this wheel, has tested it for pitfalls, and is willing to share. Remember, you are not in this maze of change all alone. l

poll question:

Is the ongoing Medicare sequestration negatively impacting your practice?

Log on to make your voice heard! www.RheumatologyPracticeManagement.com

September 2013

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In This Issue

PUBLISHING STAFF Senior Vice President/Group Publisher Nicholas Englezos nick@engagehc.com Manager, Client Services Zach Ceretelle zach@engagehc.com Editorial Director Dalia Buffery dalia@engagehc.com Managing Editor Lisa Neuman lneuman@the-lynx-group.com

Features

“Welcome” to the Inaugural Issue of Rheumatology Practice Management.........................................................................................................1

By Lisa Neuman

Transitioning to ICD-10...........................................................................................1

By Susanne Talebian, CUA, CPC, CUC, CCS-P, CMOM, PCS, RMM

From the Editor: A Journal Just for You................................................................1

By Iris Nichols

Associate Editor Lara J. Lorton

Simponi Aria Receives FDA Approval for RA......................................................9

Editorial Assistants Jennifer Brandt Cara Guglielmon

Effectiveness and Costs of TNF-Alpha Blocker Use for Patients with Rheumatoid Arthritis.............................................................................................12

Production Manager Melissa Lawlor

By Kavita Nair, PhD; Vahram Ghushchyan, PhD; and Ahmad Naim, MD

The Lynx Group President/CEO Brian Tyburski Chief Operating Officer Pam Rattanonont Ferris Vice President of Finance Andrea Kelly Director, Human Resources Blanche Marchitto Associate Editorial Director, Projects Division Terri Moore Director, Quality Control Barbara Marino Quality Control Assistant Theresa Salerno Director, Production & Manufacturing Alaina Pede

Departments

Medical Legal Update Breach Notification Requirements.....................................................................10

By Jennifer Kirschenbaum, Esq

Wealth Management Retirement Plans and Your Medical Practice...................................................16

By Lawrence B. Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF, and Peter M. Coleman, ASA, EA, FCA, MAAA, MBA

Practice Management Engaging Patients in Pain Management an Important Strategy for Rheumatology Practices.....................................................................................19

By Phoebe Starr

Director, Creative & Design Robyn Jacobs Creative & Design Assistant Lora LaRocca Director, Digital Media Anthony Romano Web Content Managers David Maldonado Anthony Travean Digital Programmer Michael Amundsen Senior Project Manager Andrea Boylston Project Coordinators Deanna Martinez Jackie Luma Executive Administrator Rachael Baranoski Office Coordinator Robert Sorensen

Engage Healthcare Communications 1249 South River Road - Ste 202A Cranbury, NJ 08512 phone: 732-992-1880 fax: 732-992-1881

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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 will offer 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 © 2013 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.

RHEUMATology Practice Management

I September 2013

In the fight against active, autoantibody-positive systemic lupus erythematosus (SLE) in adult patients receiving standard therapy

Add BENLYSTA to Help Make SLE More Manageable When added to standard therapy, BENLYSTA significantly reduced disease activity vs standard therapy alone at Week 521

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BENLYSTA 10 mg/kg + standard therapy demonstrated superior efficacy vs placebo + standard therapy in reducing disease activity at Week 52 in 2 Phase III trials (Total N=1684)1-3

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The primary endpoint was the percentage of patients meeting the SLE Responder Index (SRI) at Week 52. The SRI components measure reduction in disease activity defined as clinical improvement (SELENA-SLEDAI*) with no significant worsening in any organ system (BILAG†) and no worsening in overall patient condition (PGA‡)1

– •

A Phase II trial (Total N=449) did not meet the prespecified co-primary endpoints of percent change in SELENA-SLEDAI at Week 24 and time to first flare over 52 weeks. The Phase II trial led to the selection of a targeted autoantibody-positive population in the Phase III trials (28% of the Phase II trial population was autoantibody negative at baseline) 4

In Phase II and III clinical trials, 1458 patients with SLE have been exposed to BENLYSTA for a total of 1516 patient-years2-5

* SELENA-SLEDAI (Safety of Estrogens in Lupus Erythematosus: National Assessment Version of the Systemic Lupus Erythematosus Disease Activity Index). † BILAG (British Isles Lupus Assessment Group). ‡ PGA (Physician’s Global Assessment).

Indication BENLYSTA is indicated for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy.

Limitations of Use: The efficacy of BENLYSTA has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. BENLYSTA has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of BENLYSTA is not recommended in these situations.

How supplied: BENLYSTA is available as 120 mg in a 5-mL single-use vial and 400 mg in a 20-mL single-use vial for injection, for intravenous use only.

Important Safety Information for BENLYSTA CONTRAINDICATION BENLYSTA is contraindicated in patients who have had anaphylaxis with belimumab.

WARNINGS AND PRECAUTIONS MORTALITY There were more deaths reported with BENLYSTA than with placebo during the controlled period of the clinical trials. Out of 2133 patients in 3 clinical trials, a total of 14 deaths occurred in the following groups: 3/675 in placebo, 5/673 in BENLYSTA 1 mg/kg, 0/111 in BENLYSTA 4 mg/kg, and 6/674 in BENLYSTA 10 mg/kg. No single cause of death predominated. Etiologies included infection, cardiovascular disease, and suicide.

SERIOUS INFECTIONS Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents, including BENLYSTA. Caution should be exercised when considering use in patients with a history of chronic infections. Patients receiving therapy for a chronic infection should not receive BENLYSTA. Consider interrupting BENLYSTA therapy in patients who develop a new infection while receiving BENLYSTA. The most frequent serious infections included pneumonia, urinary tract infection, cellulitis, and bronchitis.

Please see additional Important Safety Information for BENLYSTA on following page.

Please see Brief Summary of Prescribing Information for BENLYSTA on adjacent pages.

www.GSKSource.com

Important Safety Information for BENLYSTA (cont’d) WARNINGS AND PRECAUTIONS (cont’d) MALIGNANCY The impact of treatment with BENLYSTA on the development of malignancies is not known. As with other immunomodulating agents, the mechanism of action of BENLYSTA could increase the risk of malignancies.

HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS) AND INFUSION REACTIONS Hypersensitivity reactions, including anaphylaxis and death, have been reported with BENLYSTA. Delay in the onset of acute hypersensitivity reactions has been observed. Patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk. Some patients received premedication; however, there is insufficient evidence to determine whether premedication diminishes the frequency or severity of these reactions.

Healthcare providers should be aware of the risk of hypersensitivity reactions, which may present as infusion reactions, and monitor patients closely. Manifestations of hypersensitivity included hypotension, angioedema, urticaria or other rash, pruritus, and dyspnea. In the event of a serious hypersensitivity reaction, discontinue BENLYSTA immediately and administer appropriate medical therapy. Infusion-associated adverse events were also reported. Serious infusion reactions included bradycardia, myalgia, headache, rash, urticaria, and hypotension.

In the event of an infusion reaction, the infusion rate may be slowed or interrupted.

Patients should be informed of the signs and symptoms of a hypersensitivity reaction and instructed to seek immediate medical care should a reaction occur.

DEPRESSION In clinical trials, psychiatric events (primarily depression, insomnia, and anxiety) were reported more frequently with BENLYSTA than with placebo. Serious psychiatric events, serious depression, and two suicides were also reported. It is unknown if BENLYSTA treatment is associated with increased risk for these events. Instruct patients to contact their healthcare provider if they experience new or worsening depression, suicidal thoughts, or other mood changes.

IMMUNIZATION Live vaccines should not be given for 30 days before or concurrently with BENLYSTA. BENLYSTA may interfere with the response to immunizations.

USE WITH BIOLOGIC THERAPIES OR IV CYCLOPHOSPHAMIDE BENLYSTA has not been studied in combination with other biologic therapies, including B-cell targeted therapies, or IV cyclophosphamide.

Therefore, use of BENLYSTA is not recommended in combination with these therapies.

ADVERSE REACTIONS The most commonly reported adverse reactions (≥5%) were nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, and pharyngitis.

Other Important Information for BENLYSTA USE IN SPECIFIC POPULATIONS Pregnancy: Category C. BENLYSTA should be used during pregnancy only if the potential benefit outweighs the risk. Women of childbearing potential should use adequate contraception during BENLYSTA treatment and for at least 4 months after the last dose.

Pregnancy Registry: Healthcare professionals are encouraged to register patients and pregnant women are encouraged to enroll themselves by calling 1-877-681-6296.

Effect in black/African American patients: In exploratory analyses of 2 Phase III trials, response rates were lower for black patients (N=148) in the BENLYSTA group relative to black patients in the placebo group. In the Phase II trial, black patients (N=106) in the BENLYSTA group did not appear to have a different response than the rest of the study population. Although no definitive conclusions can be drawn from these analyses, caution should be used when considering BENLYSTA for black/African American patients.

References: 1. BENLYSTA [package insert]. Rockville, MD: Human Genome Sciences, Inc; 2012. 2. Navarra SV, Guzmán RM, Gallacher AE, et al. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet. 2011;377(9767):721-731. 3. Furie R, Petri M, Zamani O, et al. A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus.

Arthritis Rheum. 2011;63(12):3918-3930. 4. Wallace DJ, Stohl W, Furie RA, et al. A phase II, randomized, double-blind, placebo-controlled, dose-ranging study of belimumab in patients with active systemic lupus erythematosus. Arthritis Rheum. 2009;61(9):1168-1178. 5. Data on file, Human Genome Sciences, Inc.

Please see Brief Summary of Prescribing Information for BENLYSTA on adjacent pages.

©2013 The GlaxoSmithKline Group of Companies All rights reserved. Printed in USA. BN2289R0 February 2013

BRIEF SUMMARY BENLYSTA® (belimumab) for injection, for intravenous use only.

The following is a brief summary only; see full Prescribing Information for complete product information.

INDICATIONS AND USAGE BENLYSTA® (belimumab) is indicated for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy.

Limitations of Use The efficacy of BENLYSTA has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus.

BENLYSTA has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of BENLYSTA is not recommended in these situations.

CONTRAINDICATIONS BENLYSTA is contraindicated in patients who have had anaphylaxis with belimumab.

WARNINGS AND PRECAUTIONS Mortality There were more deaths reported with BENLYSTA than with placebo during the controlled period of the clinical trials. Out of 2133 patients in 3 clinical trials, a total of 14 deaths occurred during the placebo-controlled, double-blind treatment periods: 3/675 (0.4%), 5/673 (0.7%), 0/111 (0%), and 6/674 (0.9%) deaths in the placebo, BENLYSTA 1 mg/kg, BENLYSTA 4 mg/kg, and BENLYSTA 10 mg/kg groups, respectively. No single cause of death predominated. Etiologies included infection, cardiovascular disease and suicide.

Serious Infections Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents, including BENLYSTA. Physicians should exercise caution when considering the use of BENLYSTA in patients with chronic infections. Patients receiving any therapy for chronic infection should not begin therapy with BENLYSTA. Consider interrupting BENLYSTA therapy in patients who develop a new infection while undergoing treatment with BENLYSTA and monitor these patients closely.

In the controlled clinical trials, the overall incidence of infections was 71% in patients treated with BENLYSTA compared with 67% in patients who received placebo. The most frequent infections (>5% of patients receiving BENLYSTA) were upper respiratory tract infection, urinary tract infection, nasopharyngitis, sinusitis, bronchitis, and influenza. Serious infections occurred in 6.0% of patients treated with BENLYSTA and in 5.2% of patients who received placebo. The most frequent serious infections included pneumonia, urinary tract infection, cellulitis, and bronchitis.

Infections leading to discontinuation of treatment occurred in 0.7% of patients receiving BENLYSTA and 1.0% of patients receiving placebo.

Infections resulting in death occurred in 0.3% (4/1458) of patients treated with BENLYSTA and in 0.1% (1/675) of patients receiving placebo.

Malignancy The impact of treatment with BENLYSTA on the development of malignancies is not known. In the controlled clinical trials, malignancies (including non-melanoma skin cancers) were reported in 0.4% of patients receiving BENLYSTA and 0.4% of patients receiving placebo. In the controlled clinical trials, malignancies, excluding non-melanoma skin cancers, were observed in 0.2% (3/1458) and 0.3% (2/675) of patients receiving BENLYSTA and placebo, respectively. As with other immunomodulating agents, the mechanism of action of BENLYSTA could increase the risk for the development of malignancies.

Hypersensitivity Reactions, Including Anaphylaxis Hypersensitivity reactions, including anaphylaxis and death, have been reported in association with BENLYSTA. Delay in the onset of acute hypersensitivity reactions has been observed. Limited data suggest that patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk. In the controlled clinical trials, hypersensitivity reactions (occurring on the same day of infusion) were reported in 13% (191/1458) of patients receiving BENLYSTA and 11% (76/675) of patients receiving placebo. Anaphylaxis was observed in 0.6% (9/1458) of patients receiving BENLYSTA and 0.4% (3/675) of patients receiving placebo.

Manifestations included hypotension, angioedema, urticaria or other rash, pruritus, and dyspnea. Due to overlap in signs and symptoms, it was not possible to distinguish between hypersensitivity reactions and infusion reactions in all cases [see Warnings and Precautions]. Some patients (13%) received premedication, which may have mitigated or masked a hypersensitivity response; however, there is insufficient evidence to determine whether premedication diminishes the frequency or severity of hypersensitivity reactions.

BENLYSTA should be administered by healthcare providers prepared to manage anaphylaxis. In the event of a serious reaction, administration of BENLYSTA must be discontinued immediately and appropriate medical therapy administered. Patients should be monitored during and for an appropriate period of time after administration of BENLYSTA. Patients should be informed of the signs and symptoms of a hypersensitivity reaction and instructed to seek immediate medical care should a reaction occur.

Infusion Reactions In the controlled clinical trials, adverse events associated with the infusion (occurring on the same day of the infusion) were reported in 17% (251/1458) of patients receiving BENLYSTA and 15% (99/675) of patients receiving placebo. Serious infusion reactions (excluding hypersensitivity

reactions) were reported in 0.5% of patients receiving BENLYSTA and 0.4% of patients receiving placebo and included bradycardia, myalgia, headache, rash, urticaria, and hypotension. The most common infusion reactions (≥ 3% of patients receiving BENLYSTA) were headache, nausea, and skin reactions. Due to overlap in signs and symptoms, it was not possible to distinguish between hypersensitivity reactions and infusion reactions in all cases [see Warnings and Precautions]. Some patients (13%) received premedication, which may have mitigated or masked an infusion reaction; however there is insufficient evidence to determine whether premedication diminishes the frequency or severity of infusion reactions [see Adverse Reactions].

BENLYSTA should be administered by healthcare providers prepared to manage infusion reactions. The infusion rate may be slowed or interrupted if the patient develops an infusion reaction. Healthcare providers should be aware of the risk of hypersensitivity reactions, which may present as infusion reactions, and monitor patients closely.

Depression In the controlled clinical trials, psychiatric events were reported more frequently with BENLYSTA (16%) than with placebo (12%), related primarily to depression-related events (6.3% BENLYSTA and 4.7% placebo), insomnia (6.0% BENLYSTA and 5.3% placebo), and anxiety (3.9% BENLYSTA and 2.8% placebo). Serious psychiatric events were reported in 0.8% of patients receiving BENLYSTA (0.6% and 1.2% with 1 and 10 mg/kg, respectively) and 0.4% of patients receiving placebo. Serious depression was reported in 0.4% (6/1458) of patients receiving BENLYSTA and 0.1% (1/675) of patients receiving placebo. Two suicides (0.1%) were reported in patients receiving BENLYSTA. The majority of patients who reported serious depression or suicidal behavior had a history of depression or other serious psychiatric disorders and most were receiving psychoactive medications. It is unknown if BENLYSTA treatment is associated with increased risk for these events.

Patients receiving BENLYSTA should be instructed to contact their healthcare provider if they experience new or worsening depression, suicidal thoughts, or other mood changes.

Immunization Live vaccines should not be given for 30 days before or concurrently with BENLYSTA as clinical safety has not been established. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving BENLYSTA or the effect of BENLYSTA on new immunizations. Because of its mechanism of action, BENLYSTA may interfere with the response to immunizations.

Concomitant Use with Other Biologic Therapies or Intravenous Cyclophosphamide BENLYSTA has not been studied in combination with other biologic therapies, including B-cell targeted therapies, or intravenous cyclophosphamide. Therefore, use of BENLYSTA is not recommended in combination with biologic therapies or intravenous cyclophosphamide.

ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trials Experience The data described below reflect exposure to BENLYSTA plus standard of care compared with placebo plus standard of care in 2133 patients in 3 controlled studies. Patients received BENLYSTA at doses of 1 mg/kg (N=673), 4 mg/kg (N=111; Trial 1 only), or 10 mg/kg (N=674) or placebo (N=675) intravenously over a 1-hour period on Days 0, 14, 28, and then every 28 days. In two of the studies (Trial 1 and Trial 3), treatment was given for 48 weeks, while in the other study (Trial 2) treatment was given for 72 weeks [see Clinical Studies]. Because there was no apparent dose-related increase in the majority of adverse events observed with BENLYSTA, the safety data summarized below are presented for the 3 doses pooled, unless otherwise indicated; the adverse reaction table displays the results for the recommended dose of 10 mg/kg compared with placebo.

The population had a mean age of 39 (range 18-75), 94% were female, and 52% were Caucasian. In these trials, 93% of patients treated with BENLYSTA reported an adverse reaction compared with 92% treated with placebo.

The most common serious adverse reactions were serious infections (6.0% and 5.2% in the groups receiving BENLYSTA and placebo, respectively) [see Warnings and Precautions].

The most commonly-reported adverse reactions, occurring in ≥5% of patients in clinical trials were nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, and pharyngitis.

The proportion of patients who discontinued treatment due to any adverse reaction during the controlled clinical trials was 6.2% for patients receiving BENLYSTA and 7.1% for patients receiving placebo. The most common adverse reactions resulting in discontinuation of treatment (≥1% of patients receiving BENLYSTA or placebo) were infusion reactions (1.6% BENLYSTA and 0.9% placebo), lupus nephritis (0.7% BENLYSTA and 1.2% placebo), and infections (0.7% BENLYSTA and 1.0% placebo).

Brief summary of Prescribing Information continued on reverse.

Table 1 lists adverse reactions, regardless of causality, occurring in at least 3% of patients with SLE who received BENLYSTA 10 mg/kg and at an incidence at least 1% greater than that observed with placebo in the 3 controlled studies.

Pregnancy Registry: To monitor maternal-fetal outcomes of pregnant women exposed to BENLYSTA, a pregnancy registry has been established.

Healthcare professionals are encouraged to register patients and pregnant women are encouraged to enroll themselves by calling 1-877-681-6296.

Table 1. Incidence of Adverse Reactions Occurring in at Least 3% of Patients Treated With BENLYSTA 10 mg/kg Plus Standard of Care and at Least 1% More Frequently Than in Patients Receiving Placebo plus Standard of Care in 3 Controlled SLE Studies

Nursing Mothers It is not known whether BENLYSTA is excreted in human milk or absorbed systemically after ingestion. However, belimumab was excreted into the milk of cynomolgus monkeys. Because maternal antibodies are excreted in human breast milk, a decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of breastfeeding to the infant and the importance of the drug to the mother.

Preferred Term Nausea Diarrhea Pyrexia Nasopharyngitis Bronchitis Insomnia Pain in extremity Depression Migraine Pharyngitis Cystitis Leukopenia Gastroenteritis viral

BENLYSTA 10 mg/kg + Standard of Care (n = 674) %

Placebo + Standard of Care (n = 675) %

15 12 10 9 9 7 6 5 5 5 4 4 3

12 9 8 7 5 5 4 4 4 3 3 2 1

Immunogenicity In Trials 2 and 3, anti-belimumab antibodies were detected in 4 of 563 (0.7%) patients receiving BENLYSTA 10 mg/kg and in 27 of 559 (4.8%) patients receiving BENLYSTA 1 mg/kg. The reported frequency for the group receiving 10 mg/kg may underestimate the actual frequency due to lower assay sensitivity in the presence of high drug concentrations. Neutralizing antibodies were detected in 3 patients receiving BENLYSTA 1 mg/kg. Three patients with anti-belimumab antibodies experienced mild infusion reactions of nausea, erythematous rash, pruritus, eyelid edema, headache, and dyspnea; none of the reactions was life-threatening. The clinical relevance of the presence of anti-belimumab antibodies is not known.

The data reflect the percentage of patients whose test results were positive for antibodies to belimumab in specific assays. The observed incidence of antibody positivity in an assay is highly dependent on several factors, including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to belimumab with the incidence of antibodies to other products may be misleading.

DRUG INTERACTIONS Formal drug interaction studies have not been performed with BENLYSTA. In clinical trials of patients with SLE, BENLYSTA was administered concomitantly with other drugs, including corticosteroids, antimalarials, immunomodulatory and immunosuppressive agents (including azathioprine, methotrexate, and mycophenolate), angiotensin pathway antihypertensives, HMG-CoA reductase inhibitors (statins), and NSAIDs without evidence of a clinically meaningful effect of these concomitant medications on belimumab pharmacokinetics. The effect of belimumab on the pharmacokinetics of other drugs has not been evaluated [see Pharmacokinetics].

USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C. There are no adequate and well-controlled clinical studies using BENLYSTA in pregnant women. Immunoglobulin G (IgG) antibodies, including BENLYSTA, can cross the placenta. Because animal reproduction studies are not always predictive of human response, BENLYSTA should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Women of childbearing potential should use adequate contraception during treatment with BENLYSTA and for at least 4 months after the final treatment.

Nonclinical reproductive studies have been performed in pregnant cynomolgus monkeys receiving belimumab at doses of 0, 5 and 150 mg/kg by intravenous infusion (the high dose was approximately 9 times the anticipated maximum human exposure) every 2 weeks from gestation day 20 to 150. Belimumab was shown to cross the placenta. Belimumab was not associated with direct or indirect teratogenicity under the conditions tested. Fetal deaths were observed in 14%, 24% and 15% of pregnant females in the 0, 5 and 150 mg/kg groups, respectively. Infant deaths occurred with an incidence of 0%, 8% and 5%. The cause of fetal and infant deaths is not known. The relevance of these findings to humans is not known. Other treatment-related findings were limited to the expected reversible reduction of B cells in both dams and infants and reversible reduction of IgM in infant monkeys. B-cell numbers recovered after the cessation of belimumab treatment by about 1 year post-partum in adult monkeys and by 3 months of age in infant monkeys. IgM levels in infants exposed to belimumab in utero recovered by 6 months of age.

Pediatric Use Safety and effectiveness of BENLYSTA have not been established in children.

Geriatric Use Clinical studies of BENLYSTA did not include sufficient numbers of subjects aged 65 or over to determine whether they respond differently from younger subjects. Use with caution in elderly patients.

Race In Trial 2 and Trial 3, response rates for the primary endpoint were lower for black subjects in the BENLYSTA group relative to black subjects in the placebo group [see Clinical Studies]. Use with caution in black/AfricanAmerican patients.

OVERDOSAGE There is no clinical experience with overdosage of BENLYSTA. Two doses of up to 20 mg/kg have been given by intravenous infusion to humans with no increase in incidence or severity of adverse reactions compared with doses of 1, 4, or 10 mg/kg.

PATIENT COUNSELING INFORMATION See Medication Guide.

Advice for the Patient Patients should be given the Medication Guide for BENLYSTA and provided an opportunity to read it prior to each treatment session. It is important that the patient’s overall health be assessed at each infusion visit and any questions resulting from the patient’s reading of the Medication Guide be discussed.

Mortality: Patients should be advised that more patients receiving BENLYSTA in the main clinical trials died than did patients receiving placebo treatment [see Warnings and Precautions].

Serious Infections: Patients should be advised that BENLYSTA may decrease their ability to fight infections. Patients should be asked if they have a history of chronic infections and if they are currently on any therapy for an infection [see Warnings and Precautions]. Patients should be instructed to tell their healthcare provider if they develop signs or symptoms of an infection.

Hypersensitivity/Anaphylactic and Infusion Reactions: Educate patients on the signs and symptoms of anaphylaxis, including wheezing, difficulty breathing, peri-oral or lingual edema, and rash. Patients should be instructed to immediately tell their healthcare provider if they experience symptoms of an allergic reaction during or after the administration of BENLYSTA [see Warnings and Precautions].

Depression: Patients should be instructed to contact their healthcare provider if they experience new or worsening depression, suicidal thoughts or other mood changes. [see Warnings and Precautions].

Immunizations: Patients should be informed that they should not receive live vaccines while taking BENLYSTA. Response to vaccinations could be impaired

by BENLYSTA [see Warnings and Precautions].

Pregnancy and Nursing Mothers: Patients should be informed that BENLYSTA has not been studied in pregnant women or nursing mothers so the effects of BENLYSTA on pregnant women or nursing infants are not known. Patients should be instructed to tell their healthcare provider if they are pregnant, become pregnant, or are thinking about becoming pregnant [see Use in Specific Populations]. Patients should be instructed to tell their healthcare provider if they plan to breastfeed their infant [see Use in Specific Populations].

BENLYSTA is a registered trademark of Human Genome Sciences, Inc., used under license by GlaxoSmithKline.

Manufactured by: Human Genome Sciences, Inc. Rockville, Maryland 20850 U.S. License No. 1820 Marketed by:

Human Genome Sciences, Inc. Rockville, MD 20850

GlaxoSmithKline Research Triangle Park, NC 27709

On the Cover

“Welcome” to the Inaugural Issue... Continued from page 1 practice manager, the same valuable information that we’ve been able to provide your colleagues in oncology and urology practices for the past several years.

Our practice management publications focus on process solutions for medical practices, and Rheumatology Practice Management is designed to provide the rheumatology care team with the knowledge and skills required to keep abreast of today’s fast-changing medical/business environment. Each issue will feature current hot topics of interest, such as healthcare technology implementation; the new models of care; staffing and personnel issues; reimbursement and coding changes; drug updates and clinical trial information; social

media and marketing; and the near- and long-term impacts of the Affordable Care Act. To help us achieve our editorial mission, we are very pleased to partner with the National Organization of Rheumatology Managers (NORM), a growing and vibrant group of practice managers and administrators committed to the role that process excellence plays in providing exceptional patient care. We look forward to drawing on NORM members’ vast knowledge and expertise as we develop the content that will help you manage your practice to peak efficiency.

To make our publications as dynamic as they can be, our policy is to always encourage our readers to give their input and ideas, and with

the launch of Rheumatology Practice Management, we’re asking you to do the same. Have a practice management tip you’d love to share with your colleagues all over the country?

Tell us about it and we’ll help you develop an article about it. Have a question about an aspect of running your practice and would like to get other practice managers’ opinions and advice? Write to us and we’ll post your question in the book and on our website.

We look forward to a long relationship with you, providing you with the information and advice you need to excel at your critical function in today’s healthcare environment. Thank you for reading, and thank you for your support. l FDA Update

Simponi Aria Receives FDA Approval for RA The US Food and Drug Admini­ stration (FDA) approved a new indication for golimumab (Simponi Aria for infusion; Janssen Biotech) for the treatment of adult patients with moderate-to-severe rheumatoid arthritis (RA) to be used in combination with methotrexate.

Only 2 months earlier, the FDA approved golimumab injection for the treatment of patients with ulcerative colitis.

This is the first FDA approval of a fully human anti–tumor necrosis factor (TNF) therapy for infusion. The approval was based on findings from the phase 3 clinical trial known as GO-FURTHER (Golimumab, an Anti- TNFalpha Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate

Therapy). The study included 592 patients with moderate-to-severe active RA who had at least 6 tender and 6 swollen joints, as well as elevated C-reactive protein levels, and who had been receiving background methotrexate for ≥3 months.

At week 14, 30% of the patients receiving golimumab plus methotrexate achieved at least a 50% improvement in American College of Rheumatology (ACR) response criteria (ACR50) compared with 9% of the patients receiving placebo plus methotrexate (95% confidence interval, 15.3-27.2). Significant improvements in ACR20 were seen as early as week 2: 33% of patients achieved an ACR20 response after 1 infusion of golimumab versus 12% of patients receiving placebo.

Golimumab is administered as an intravenous dose of 2 mg/kg at

September 2013

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weeks 0 and 4 and then every 8 weeks. The drug is infused over a 30-minute period.

In the GO-FURTHER trial, golimumab significantly improved the signs and symptoms of RA by week 24 “and inhibited the progression of structural damage in patients with moderate to severe RA at week 24 and 52,” said Sergio Schwartzman, MD, Director, Inflammatory Arthritis Center, Hospital for Special Surgery, and Associate Professor, Weill Cornell Medical College, New York, NY. This approval “offers rheumatologists a new anti-TNF infusible treatment for patients who demonstrate an inadequate response to methotrexate; having treatment options remains critical for us to continue to meet the needs of our patients,” Dr Schwartzman added.

(July 18, 2013)

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9

Medical Legal Update

Breach Notification Requirements

By Jennifer Kirschenbaum, Esq

I

t should be no surprise to read that medical practices have an obligation to maintain protected health information in certain ways, and to only use and disclose such protected health information as authorized by the patient or otherwise by law. Such requirements are set forth under the Privacy Rule.

What you may be surprised to read is that when protected health information is not maintained by a medical practice in accordance with HIPAA, notification to the patient or other sources may be required pursuant to the Breach Notification Rule (45 CFR Part 164). You may not be aware of the Breach Notification Rule because it was part of proposed modifications set forth several years ago, and many practices did not adopt the requirements of the rule because the statute at that time had not been written with teeth.

However, the Final Rule promulgated on January 25, 2013, not only modifies the Breach Notification Rule, it incorporates significant en­ forcement provisions, should a breach occur and not be dealt with appropriately by the practice.

Effective September 23, 2013, every medical practice is required to notify an individual of an acquisition, access, use, or disclosure of protected health information in a manner not permitted under the Privacy Rule, otherwise known as a breach. Pursuant to the statute, a breach excludes:

1

Any unintentional acquisition, access, or use of protected health information by a workforce member

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or person acting under the authority of the practice or a business associate, if such acquisition, access, or use was made in good faith and within the scope of authority and does not result in further use or disclosure in a manner not permitted under the practice’s privacy policy.

2

Any inadvertent disclosure by a person who is authorized to access protected health information at the practice, or a business associate, to another person authorized to access protected health infor-

When protected health information is not maintained by a medical practice in accordance with HIPAA, notification to the patient or other sources may be required pursuant to the Breach Notification Rule. mation at the same practice, or business associate, or an organized healthcare arrangement in which the practice participates, and the information received as a result of such disclosure is not further used or disclosed in a manner not permitted under the practice’s privacy policy.

3

A disclosure of protected health information where the practice, or business associate, has a goodfaith belief that an unauthorized person to whom the disclosure was

RHEUMATology Practice Management

I September 2013

made would not reasonably have been able to retain such information.

4

Where the practice has demonstrated that there is a low probability that the protected health information has been compromised based on a risk assessment of at least the following factors: A. The nature and extent of the protected health information involved, including the types of identifiers and the likelihood of reidentification B. The unauthorized person who used the protected health information or to whom the disclosure was made C. Whether the protected health information was actually ac­­ quired or viewed D. The extent to which the risk to the protected health information has been mitigated (45 CFR 164.402).

Notification is required at several levels: (1) to the individual, (2) to the media, and (3) to the Secretary of the US Department of Health and Human Services (HHS). Each requirement will be addressed in turn below.

To the Individual Notification to the individual is required where, after a risk assessment, it has been determined that protected health information has been—or is reasonably believed by the practice to have been— accessed, acquired, used, or disclosed as a result of a breach. A breach shall be treated as being discovered by the practice on the first day that the breach is actually known to the practice or, by exercising reasonable diligence, would have been known to the practice, meaning that, if

Medical Legal Update

such breach is known—or by exercising reasonable diligence would have been known—to any person who is a workforce member or agent of the covered entity other than the person committing the breach.

Notification to the individual is required no later than 60 calendar days after the discovery of a breach, and in the notification the practice is required to provide, to the extent possible, the following information: • A brief description of what happened, including the date of the breach and the date of the discovery of the breach, if the date is known • A description of the types of unsecured protected health information that were involved in the breach (such as whether the individual’s full name, social security number, date of birth, home address, account number, diagnosis, disability code, or other types of information were involved) • Any steps that the individual should take to protect himself or herself from potential harm resulting from the breach • A brief description of what the covered entity involved is doing to investigate the breach, to mitigate harm to the individual, and to protect against any further breaches • Contact procedures for the individual to ask questions or learn additional information, which shall include a toll-free telephone number, an e-mail address, website, and/or postal address.

Notification is required to be sent in writing by first-class mail to the individual at the last known address of the individual or, if the individual agrees to electronic notice and such agreement has not been withdrawn, by electronic mail. The notification may be provided in 1

or more mailings as information is available. If the practice knows that the individual is deceased and has the address of his or her next of kin or personal representative, written notification by first-class mail to either the next of kin or personal representative must be made. Again, the notification may be provided in 1 or more mailings as information is available.

In a case where there is insufficient or out-of-date contact information that precludes written notification to the individual, substitute notice may be provided. In a breach where more than 10 individuals are affected, substitute notice may take the form of either a conspicuous posting on the home page of the practice’s website for a period of 90 days, or a conspicuous notice in major print and/or broadcast media outlets in the geographic areas where the affected individuals likely reside, that includes a toll-free phone number that remains active for at least 90 days where individuals can learn whether their unsecured protected health information may be included in the breach. (See 45 CFR 164.404.)

To the Media When more than 500 residents of a state or jurisdiction are involved in a protected health information breach, the practice is required to notify prominent media outlets serving the state or jurisdiction within 60 calendar days after the discovery of the breach. (See 45 CFR 164.406.)

To the HHS Secretary The practice must also notify the Secretary of HHS when a breach has occurred that involves 500 or more individuals, in the manner and form specified on the HHS website. For all breaches involving less than 500 individuals, the prac-

September 2013

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tice shall maintain a log or other documentation of such breaches and, no later than 60 days after the end of each calendar year, provide notification to the Secretary in the manner specified on the HHS website. (See 45 CFR 164.408.)

Additional Concerns In addition to the foregoing, business associates are required to report the discovery of a breach to the practice within 60 calendar days.

(See 45 CFR 164.410.)

Failure to abide by the Breach Notification Rule may open up the practice to substantial liability. The recent modifications to HIPAA allow for the imposition of civil monetary penalties for any entity or individual in violation of any HIPAA requirement, including the Breach Notification Rule, which is why it is imperative to understand and implement the requirements of the rule. Implementation requires that the policies, procedures, and contracts of the practice reflect the requirements of the Breach Notification Rule.

To discuss your practice’s compliance needs to prepare for September 23, 2013, check out available HIPAA policies at www.healthcarepractice compliance.com, or contact Jennifer at 516-747-6700 x302 or Jennifer@ Kirschenbaumesq.com. Prior to Sep­ t­­ember 2013, all practices will be required to adopt new Notice of Privacy Practices, as well as accompanying documents, such as a Breach Notification Policy. l Jennifer Kirschenbaum, Esq, manages Kirschenbaum & Kirschenbaum’s healthcare department, which specializes in representing healthcare practitioners in regulatory compliance, audit defense, licensure, and transactional matters. She may be reached at 516-747-6700 x302 or by e-mail at Jennifer@kirschenbaumesq.com.

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11

Health Economics

Effectiveness and Costs of TNF-Alpha Blocker Use for Patients with Rheumatoid Arthritis

By Kavita Nair, PhD; Vahram Ghushchyan, PhD; and Ahmad Naim, MD This is a summary of the original article published in American Health & Drug Benefits. 2013;6(2): 126-136. Copyright Š 2013 Engage Healthcare Communications. Used with permission. The full article is available at www.AHDBonline.com.

R

heumatoid arthritis (RA) is ranked among the highest of all chronic diseases for its adverse impact on health-related quality of life (QOL), limitations in physical function, increased pain

and fatigue, and diminished work performance and attendance.1 Roughly 1.3 million adults in the United States have RA, representing approximately 1% of the population.2 Without optimal

Table 1. Differences in Healthcare Expenditures between the Study Groups (2009 US $) Unadjusted mean, $

Standard error, $

Mean marginal difference, $

P value (for mean marginal difference)

Annual medical expenditures, excluding prescriptions TNF-alpha blocker nonusers with mild RA

5972

651

Reference group

TNF-alpha blocker nonusers with moderate RA

13,148

3597

1088

.195

TNF-alpha blocker nonusers with severe RA

17,630

2349

1640

.035

TNF-alpha blocker users

13,072

2731

2096

.027

Reference group

Annual prescribed medication expenditures TNF-alpha blocker nonusers with mild RA

2301

147

TNF-alpha blocker nonusers with moderate RA

4912

991

611

.001

TNF-alpha blocker nonusers with severe RA

5645

436

698

.000

10,207

1516

2454

.000

TNF-alpha blocker users

Total annual healthcare expenditures TNF-alpha blocker nonusers with mild RA

8273

706

Reference group

TNF-alpha blocker nonusers with moderate RA

18,060

4384

1864

.037

TNF-alpha blocker nonusers with severe RA

23,275

2436

2484

.002

TNF-alpha blocker users

23,280

3449

4880

.000

Models were adjusted for number of chronic conditions, age, education, race, ethnicity, and type of insurance coverage.

RA indicates rheumatoid arthritis; TNF, tumor necrosis factor.

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RHEUMATology Practice Management

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treatment, approximately 30% of patients with RA become permanently work disabled within 2 to 3 years of diagnosis.3 Predictors of poor outcomes in the initial stages of RA include a relatively low functional score early in the disease progression, lower socioeconomic status, lower education level, strong family history of the disease, and early involvement of multiple joints.3 The 2008 American College of Rheumatology (ACR) recommendation for first-line pharmacologic treatment of RA is the use of nonbiologic disease-modifying antirheumatic drugs (DMARDs), which have been found to slow the progression of joint destruction when used over the long-term.4 If patients fail to respond to nonbiologic DMARDs, the ACR’s current recommendation is to administer biologic DMARDs, or tumor necrosis factor (TNF)-alpha blockers, to patients with moderate disease activity and poor prognosis, as well as to patients with high disease activity and to patients with RA of intermediate or long duration.4 TNF-alpha blockers are frequently used along with other medications for the treatment of RA. Adalimumab, etanercept, and infliximab are the primary biologic drugs (and TNF-alpha blockers) recommended in the 2008 ACR guidelines.

The cost of untreated RA represents a significant financial burden on the US healthcare system

Health Economics

Table 2. Differences in Healthcare Utilization between the Study Groups Unadjusted mean

Standard error

Incidence rate ratio

95% confidence interval

P value

Office visits, N TNF-alpha blocker nonusers with mild RA

12.09

0.71

Reference group

TNF-alpha blocker nonusers with moderate RA

12.83

1.13

0.88

0.71-1.10

.274

TNF-alpha blocker nonusers with severe RA

19.55

3.57

0.88

0.71-1.09

.243

TNF-alpha blocker users

19.63

3.18

1.16

0.96-1.40

.131

TNF-alpha blocker nonusers with mild RA

1.26

0.14

Reference group

TNF-alpha blocker nonusers with moderate RA

2.54

1.35

0.77

0.45-1.33

.353

TNF-alpha blocker nonusers with severe RA

2.28

0.46

0.68

0.44-1.04

.077

TNF-alpha blocker users

1.62

0.47

0.98

0.52-1.86

.962

TNF-alpha blocker nonusers with mild RA

0.23

0.03

Reference group

TNF-alpha blocker nonusers with moderate RA

0.58

0.10

1.59

1.10-2.31

.014

TNF-alpha blocker nonusers with severe RA

0.89

0.11

1.76

1.24-2.52

.002

TNF-alpha blocker users

0.42

0.20

1.35

0.54-3.39

.525

TNF-alpha blocker nonusers with mild RA

0.76

0.14

Reference group

TNF-alpha blocker nonusers with moderate RA

2.40

0.54

1.40

0.85-2.29

.188

TNF-alpha blocker nonusers with severe RA

4.15

0.99

2.24

1.24-4.04

.008

TNF-alpha blocker users

1.48

0.73

1.64

0.71-3.79

.248

Outpatient visits, N

Emergency department visits, N

Hospitalizations, N

Average length of stay, days TNF-alpha blocker nonusers with mild RA

0.16

0.03

Reference group

TNF-alpha blocker nonusers with moderate RA

0.44

0.09

1.56

0.99-2.45

.053

TNF-alpha blocker nonusers with severe RA

0.59

0.08

1.65

1.07-2.53

.022

TNF-alpha blocker users

0.40

0.15

1.91

0.86-4.23

.112

Prescription medications, refills included, N TNF-alpha blocker nonusers with mild RA

28.98

1.35

Reference group

TNF-alpha blocker nonusers with moderate RA

53.36

5.00

1.22

1.04-1.43

.012

TNF-alpha blocker nonusers with severe RA

69.77

4.90

1.25

1.07-1.46

.006

TNF-alpha blocker users

52.24

5.35

1.49

1.22-1.82

.000

Models were adjusted for number of chronic conditions, age, education, race, ethnicity, and type of insurance coverage.

RA indicates rheumatoid arthritis; TNF, tumor necrosis factor.

and the economy, predominantly because of lost productivity.5,6 A US claims-based analysis of excess payer- and beneficiary-paid costs per patient with RA (compared with matched controls) reported annual excess healthcare costs of $8.4 billion, indirect costs of $10.9 billion, and total annual societal costs of $19.3 billion, including

direct, indirect, and intangible costs, such as QOL deterioration.7 According to this analysis, patients incurred an estimated 28% of that burden, employers incurred 33%, the government incurred 20%, and caregivers incurred an estimated 19% of the total cost. Adding intangible costs of QOL deterioration ($10.3 billion) and premature

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mortality ($9.6 billion), the total annual societal costs of RA (direct, indirect, and intangible) increased to $39.2 billion.7 Benefits in terms of enhanced productivity and quality-adjusted life-years conferred by the use of TNF-alpha blockers have been demonstrated in several cost-effecContinued on page 14

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Health Economics

Effectiveness and Costs of TNF-Alpha Blocker... Continued from page 13

14

tiveness analyses.8-10 These evaluations have been based on the concept that, if treated, patients with RA will not progress to a greater disease severity—or will not progress as quickly—and thereby will avoid or defer the high costs and low utilization associated with more severe and progressed disease.11

The objective of the study was to use data from the MEPS for the following outcomes—healthcare expenditures, utilization, and self-reported productivity—and to compare these outcomes between patients with RA who are TNFalpha blocker users and TNF-alpha blocker nonusers with mild, moderate, or severe RA.

Study Background The Medical Expenditure Pan­ el Survey (MEPS) database, co­ spon­ sored by the Agency for Healthcare Research and Quality and the National Center for Health Statistics, is a nationally representative survey of the US civilian noninstitutionalized population. The uniqueness of the MEPS database lies in its abundance of information, which includes patient self-reported outcomes of functioning and mental health, along with information on sociodemographics, medical utilization, cost of healthcare services, employment, missed workdays, and Short Form (SF)-12 scores. The ability to link these many domains within the MEPS data source allowed the authors of this study to develop different severity categories for RA based on a unique algorithm created for the study. This RA severity–ranking algorithm was based on 5 health-related outcomes (ie, SF-12 physical and mental summary scores, patient’s perceived physical and mental health status, and the number of comorbid conditions), which were used to group TNF-alpha blocker nonusers into the 3 mutually exclusive RA severity cohorts—mild, moderate, and severe RA. Patients with RA using TNF-alpha blockers were not grouped using this algorithm and were not ranked. In addition, the MEPS data provide self-reports of work loss because of illness.

Outcome Measures Total annual healthcare expenditures were defined as the sum of all-cause medical and pharmacy expenditures; in addition, medical and pharmacy expenditures were described separately, and were inflation adjusted to 2010 costs.

Medical service utilization and pharmacy components included the all-cause annual number of office-based visits, outpatient visits, hospitalizations, average length of stay for hospitalizations, as well as the annual number of prescribed medications.

Each person in the MEPS database has a record of his/her total annual wages. The MEPS medical conditions file in the MEPS database contains 3-digit International Classification of Diseases, Ninth Revision, Clinical Modification (ICD9-CM) codes based on medical and pharmacy utilization and self-reporting. The authors identified patients with RA by the presence of the ICD-9 diagnosis code 714, and stratified them into 1 of 2 major groups: TNF-alpha blocker users and TNF-alpha blocker nonusers.

Users of TNF-alpha blockers were identified on the basis of pharmacy utilization and/or relevant intravenous therapy at office-based or outpatient visits with the ICD-9-CM diagnosis code 714.

TNF-alpha blocker nonusers were classified into 1 of 3 groups according to RA severity ranking (mild, mod-

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I September 2013

erate, or severe). Users of TNF-alpha blockers were not included in the severity-ranking analysis, because of the assumption that patients with the most severe form of RA were taking these medications, which is typically normative practice for this patient population.

Results A total of 1152 patients were included in the study. Approxi­ mately 5.6% of the patients (N = 65) were using TNF-alpha blockers. Of the patients with RA who were not using these drugs, 720 patients (62.50%) had mild RA, 159 (13.81%) had moderate RA, and 208 (18.05%) had severe RA. Approximately 70% to 75% of the patients in all groups were female. The mean age ranged from 55 years to 60 years across the various study cohorts. Between 80% and 90% of all patients were white, and one third of all members resided in the Midwest or in the South.

Healthcare Expenditures The incremental impact on annual medical expenditures, prescribed medication expenditures, and total healthcare expenditures is shown in Table 1. All 3 categories of expenditures were higher for TNF-alpha blocker users compared with non­ users with mild RA. For example, on average, TNF-alpha blocker users spent $2096 more in annual medical expenditures compared with TNFalpha blocker nonusers with mild RA (the reference group).

Similarly, on average, TNFalpha blocker users spent $2454 more in annual prescribed expenditures and $4880 more in total healthcare expenditures compared with TNF-alpha blocker nonusers with mild RA. Total healthcare expenditures, on average, were $1864 higher for

Health Economics

TNF-alpha blocker nonusers with moderate RA and $2484 higher for TNF-alpha blocker nonusers with severe RA compared with TNF-alpha blocker nonusers with mild RA. Annual prescription expenditures were $611 higher for TNF-alpha blocker nonusers with moderate RA and $698 higher for TNF-alpha blocker nonusers with severe RA compared with patients with mild RA, and annual medical expenditures were $1088 higher for TNF-alpha blocker nonusers with moderate RA and $1640 higher for TNF-alpha blocker nonusers with severe RA compared with TNF-alpha blocker nonusers with mild RA.

Healthcare Resource Utilization The notable differences in medical service utilization between the various study groups were with regard to all-cause emergency de­ partment visits, the number of hospitalizations, the average length of stay for a hospitalization, and the number of prescribed medications (Table 2).

Significant differences with regard to emergency department visits and hospitalizations were observed between TNF-alpha blocker non­ users with severe RA and TNF-alpha blocker nonusers with mild RA. The differences in the number of prescribed medications were significant between TNF-alpha blocker users and nonusers with mild RA, as well as between TNF-alpha blocker users with severe RA and nonusers with mild RA. With regard to emergency department visits and hospitalizations, TNF-alpha blocker nonusers with severe RA were almost twice as likely to incur an emergency department visit and a hospitalization compared with nonusers with

mild RA. This group was almost 1.5 times more likely to have a greater length of stay compared with nonusers with mild RA as well.

TNF-alpha blocker users had a greater likelihood of having more prescription medications as were nonusers with severe RA and nonusers with moderate RA compared with nonusers of TNF-alpha blockers with mild RA.

Discussion This study is unique in comparing how TNF-alpha blocker treatment affects patient-reported outcomes versus TNF-alpha blocker nonuse among patients with varying degrees of RA severity. The outcomes examined in this study are more detailed than those observed from claims data alone and emphasize the importance of patient-reported measures in examining how drug treatment can influence key outcomes in the management of RA. To our knowledge, this is the first study to link patterns of TNF-alpha blocker treatment to patient-reported outcomes. Our results reveal that TNF-alpha blocker treatment is associated with lower rates of hospitalizations and emergency department visits compared with other RA medications and compared with nonuse of TNF-alpha blockers in patients with moderate or severe RA. As anticipated, one of the key findings was that patients with RA who were using TNF-alpha blockers incurred the highest total healthcare, medical, and prescription expenditures compared with the other RA groups. However, despite these increased costs, the authors found that patients with severe RA who were not using TNF-alpha blockers had more emergency department visits and hospitalizations and longer hospi-

September 2013

I

tal stays compared with the other groups. Another key finding was that TNF-alpha blocker users had a greater likelihood of being employed compared with TNFalpha blocker nonusers with moderate or severe RA. Unadjusted means also show that TNF-alpha blocker users were less likely to have missed workdays compared with the other RA groups (ie, users and nonusers), although these differences were not significant. The demonstrated positive impact of TNF-alpha blocker use on employment status may be of importance to employers and to payers alike. l

References

1. Strand V, Khanna D. The impact of rheumatoid arthritis and treatment on patients’ lives. Clin Exp Rheumatol. 2010;28(3 suppl 59):S32-S40.

2. Helmick CG, Felson DT, Lawrence RC, et al; for the National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part I. Arthritis Rheum.

2008;58:15-25.

3. Rindfleisch JA, Muller D. Diagnosis and manage­ ment of rheumatoid arthritis. Am Fam Physician. 2005; 72:1037-1047.

4. Saag KG, Teng GG, Patkar NM, et al. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum. 2008;59:762-784.

5. Filipovic I, Walker D, Forster F, Curry AS. Quan­ tifying the economic burden of productivity loss in rheumatoid arthritis. Rheumatology (Oxford). 2011;50:10831090.

6. Franke LC, Ament AJ, van de Laar MA, et al.

Cost-of-illness of rheumatoid arthritis and ankylosing spondylitis. Clin Exp Rheumatol. 2009;27(4 suppl 55): S118-S123.

7. 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.

8. Davies A, Cifaldi MA, Segurado OG, Weisman MH. Cost-effectiveness of sequential therapy with tumor necrosis factor antagonists in early rheumatoid arthritis. J Rheumatol. 2009;36:16-26.

9. Kobelt G, Lindgren P, Geborek P. Costs and outcomes for patients with rheumatoid arthritis treated with biological drugs in Sweden: a model based on registry data. Scand J Rheumatol. 2009;38:409-418.

10. Brennan A, Bansback N, Nixon R, et al. Modelling the cost effectiveness of TNF-alpha antagonists in the management of rheumatoid arthritis: results from the British Society for Rheumatology Biologics Registry.

Rheumatology (Oxford). 2007;46:1345-1354.

11. Benucci M, Li Gobbi F, Sabadini L, et al. The economic burden of biological therapy in rheumatoid arthritis in clinical practice: cost-effectiveness analysis of sub-cutaneous anti-TNFalpha treatment in Italian patients. Int J Immunopathol Pharmacol.

2009;22:1147-1152.

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15

Wealth Management With Lawrence B. Keller, CFP®, CLU, ChFC, RHU, LUTCF

Retirement Plans and Your Medical Practice

By Lawrence B. Keller, CFP®, CLU, ChFC, RHU, LUTCF, and Peter M. Coleman, ASA, EA, FCA, MAAA, MBA

lation, but, as a result, receive the most favorable tax treatment. Two of the biggest benefits are (1) immediate income tax deductions, and (2) creditor protection.

Lawrence B. Keller

I

Peter M. Coleman

n today’s turbulent economic times, physicians are looking for solutions that provide tax de­ductions and the opportunity to save efficiently for their retirement.

No matter whether you are self-employed, run a small medical practice, own shares in a large surgical center, or are directly involved in running a corporation/tax-exempt organization, you have the ability to establish a qualified retirement program for you and for your employees.

However, how do you create a retirement program to maximize your tax-deductible contributions without “breaking the bank” on em­ ployee costs? This article presents plan design concepts successfully used by others in the medical community, to help you better understand the elements that go into a well-designed and well-executed retirement program.

What Is a Qualified Retirement Plan?

The term “qualified” generally indicates that the plan must meet statutory requirements under the Employee Retirement Income Security Act of 1974 (ERISA), regarding issues such as participant eligibility, benefit coverage, vesting, funding requirements, and employee communication. Qualified plans are subject to the most stringent regu-

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Defined Contribution versus Defined Benefit Plans As with any project, there is usually more than one way to accomplish your objective. The same holds true for retirement plans. Most people have heard about 401(k) plans, where you can defer a portion of your salary and the employer makes a discretionary contribution as a match or as a percentage of your compensation. These plans are called Defined Contribution Plans and function as a savings account that is affected by investment gains and losses. The contribution going into such a plan is “defined,” but not the end benefit.

The reverse of this is the Defined Benefit/Cash Balance Plan, in which an actuary determines the annual employer contribution that will provide a specific benefit payable at retirement.

Participants who begin saving later in life are at a distinct disadvantage in Defined Contribution Plans, because they have fewer years to accumulate funds for retirement. Conversely, Defined Benefit/ Cash Balance Plans, for these same em­ployees, allow them to accumulate considerable retirement assets in a relatively short period, because the end benefit has been predetermined.

401(k)/Profit-Sharing Plans It is common for a medical practice to combine a 401(k) plan with a profit-sharing component. The 401(k) plans have become one of the most popular types of employer-sponsored retirement plans. The purpose is to permit you to defer a

RHEUMATology Practice Management

I September 2013

portion of your salary, up to $17,000 ($22,500 for those aged 50 years or older) annually, on a pretax or posttax (ie, Roth) basis. In addition, when there are ample funds, the employer can make a discretionary contribution that could increase the business owner up to $50,000 ($55,500 if aged 50 or older) in annual contributions. As your money grows in these plans, all income taxes are deferred until you take distributions at retirement.

This all sounds good, but is there a catch? The catch is that if you have employees, you must also provide them with a benefit and prove to the IRS that your plan encourages and benefits those rank-and-file employees. Although every organization’s demographics are different, some of the best design tools include the following features: • The Safe Harbor 401(k) plan is a 401(k) plan that eliminates all compliance testing. With this type of plan, employers with lowto-very-poor 401(k) participation by staff can safely defer their full $17,000 ($22,500 for those aged 50 or older) contribution, without fear that the plan will fail nondiscrimination testing and that part of their deferral will be refunded at the end of the year, creating a taxable event.

Based on the design chosen, the employer will provide either a matching benefit (ie, 100% on the first 3% deferred, plus 50% on the next 2% deferred) or a nonelective benefit (ie, 3% of salary) for all participants. The “cost” for using this plan design is that all employer contributions are immediately vested.

• When additional benefits are de­ sired, many business owners augment their 401(k) plan with a

55

53

Physician 3

Physician 4

13.2

13.2

13.2

13.2

Max

Max

Max

Max

250,000

1,000,000

250,000

250,000

250,000

22,500

90,000

22,500

22,500

22,500

33,000

132,000

33,000

33,000

33,000

238,462

812,820

169,231

187,179

217,949

271,462

944,820

202,231

220,179

250,949

52

RN 2

3.0

3.0 0.0

0.0 242,000

130,000

112,000 9680

5200

4480 7260

3900

3360 0

0

0

27

25

35

42

28

35

47

21

Staff 5

Staff 6

Staff 7

Staff 8

Staff 9

Staff 10

Staff 11

Staff 12

7.5

7.5

7.5

7.5

7.5

7.5

7.5

7.5

7.5

2.5

2.5

2.5

2.5

2.5

2.5

2.5

2.5

2.5

2.5

2.5

32,000

55,000

60,000

50,000

37,000

40,000

35,000

35,000

65,000

65,000

75,000

Estimated tax savings for partners/firm

Total

1,871,000

35

Staff 4

7.5

7.5

80,000

28

Staff 3

2.5

629,000

32

Staff 2

7.5

Subtotal: Group 3

33

Staff 1

36,000

124,840

25,160

1280

2200

2400

2000

1480

1600

1400

1400

2600

2600

3000

3200

74,600

186,435

47,175

2400

4125

4500

3750

2775

3000

2625

2625

4875

4875

5625

6000

329,500

823,844

11,024

470

1265

1068

808

726

712

543

558

1157

1051

1281

1385

Group 3: Staff

Subtotal: Group 2

40

RN 1

293,962

404,100

1,010,279

58,199

440,100

2870

5390

5568

4558

3501

3712

3168

3183

6032

5926

6906

7385

7260

3900

1,034,820

224,731

242,679

273,449

3360

Group 2: Registered nurses (RNs)

Subtotal: Group 1

60

58

Physician 1

Physician 2

Group 1: Owner physicians

100

5.1

0.2

0.5

0.5

0.4

0.3

0.3

0.3

0.3

0.4

0.5

0.6

0.7

0.8

0.4

0.4

94.1

20.4

22.1

24.9

26.7

(A)

Projected (B) (C)

Maximum voluntary Employer Employer (B) + (C) (A) + (B) + (C)

Profit- Cash salary for employee profit- defined Total Total Allocation

sharing balance benefit 401(k) sharing benefit employer partner of total

Age, contribution, contribution, purposes, deferral, contribution, contribution, contribution, benefits, benefits, Participants yr % % $ $ $ $ $ $ %

Table. The Medical Practice Traditional 401(k) Plan with New Comparability Profit-Sharing and Cash Balance Components Objective: Provide Maximum Benefit for Partners/Minimize Overall Costs

Wealth Management

Continued on page 18

Wealth Management

Retirement Plans and Your…Continued from page 17 profit-sharing feature. Offering such a plan helps to attract quality employees and reduces employee turnover. The best part about the profit-sharing contribution is that it is discretionary in nature, and you are not required to make a set contribution (or any contribution) in any given year. This flexible standard allows medical practices considerable latitude in budgeting, especially for those with varying or uncertain profits. And with a properly designed program, the majority of the contributions will be allocated to the key employees in your practice.

A Properly Designed Program What is a properly designed program? This is typically a plan in which the key staff members, inclusive of the owner(s), receive more than 60% of the total dollars going into the plan. One of the best ways we have accomplished this goal is by using a New Comparability ProfitSharing (NCPS) design. An NCPS plan will allow you to place all participants in the appropriate group and to provide them with different contribution percentages, as long as you pass discrimination tests. For example, a profit-sharing allocation for the following participants could include: • Senior physician (owner): 20% of compensation • Junior physician (owner): 10% • Office manager: 7% • Remaining staff: 5%.

The employer contributions are usually made after the end of the plan year (but before filing your taxes), and when you have determined your ability to make the contribution.

Each year, working with your retirement consultant, you determine the percentages to allocate to each group. If your demographics do not work well with this type of design, there are many other variations to

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I

choose from, including pro rata, age based, service based, and integration with Social Security wage base.

However, regardless of the design chosen, the maximum contribution any one person can receive, inclusive of the 401(k) component, is $50,000 ($55,500 for those aged 50 or older) per employee.

maintaining a reasonable cost for the staff. As a result, the owners are able to collectively contribute more than $1 million for themselves and receive more than 93% of all dollars going into the plan. In addition, if any of the physicians did not want such a large benefit, this could easily be modified.

Combination Program For some business owners, the benefits provided through a 401(k)/profit-sharing plan are just not enough.

They are looking for programs that will provide tax-deductible contributions for themselves in excess of $100,000. In these cases, the solution is the combination of a 401(k)/ ProfitSharing and Defined Benefit/Cash Balance Program. Like an NCPS, the Defined Benefit Plan can be structured to provide greater benefits for the key employees and minimize overall costs for the staff. With a De­fined Benefit Plan, after 10 years of participation and retirement at age 62, you could amass an account balance of approximately $2.5 million in addition to the account balance in your 401(k) profit-sharing plan. Please note that unlike the profit-sharing plan, the contribution to the Defined Benefit Plan is not discretionary and must be made for at least 3 to 5 years.

Conclusion When it comes to choosing an appropriate retirement program, there are many choices available, often too many. What we say to all our clients is, “Pretend there are no rules and regulations, and you can do whatever you would like. Now tell us how you would like to design your specific program.” You should never be presented a solution before you have been able to communicate exactly what you would like from your plan. More often than not, a customized retirement program can very closely mirror the objectives of your practice. Working with an experienced third-party administrator and financial advisor, you will be able to craft the right tax-efficient program for your practice. l

Multiple Plans: An Example In this hypothetical medical practice listed in the Table, there are 4 high wage earners looking for ways to defer additional sums of money in excess of the $50,000 permitted under a 401(k)/profit-sharing plan. The solution was to use the Combination Program, including a 401(k)/profit-sharing plan and a Defined Benefit/Cash Balance component. By adding on the Cash Balance Plan, the physicians’ tax-deductible contributions increased by more than $150,000 each, while still

RHEUMATology Practice Management

I September 2013

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 (516) 677-6211 or Lkeller@ physicianfinancialservices. com for comments or questions.

Peter M. Coleman, ASA, EA, FCA, MAAA, MBA, is the Managing Partner of The Benefit Practice, a firm specializing in pension consulting, administration, and related actuarial services to clients nationwide. He can be reached at (203) 517-3502 or Pcoleman@benefitpractice.com for comments or questions.

Practice Management

Engaging Patients in Pain Management an Important Strategy for Rheumatology Practices

By Phoebe Starr

New Orleans, LA—An interactive, online tool shows promise in helping patients with rheumatoid arthritis (RA) self-manage their pain and could prove to be a useful adjunct to office visits for this patient population, according to a poster presented at the 2013 American Pain Society annual meeting by a team of investigators from Inflexxion, Newton, MA. They presented findings from an intervention called painACTION, an online program for the self-management of patients with pain associated with rheumatic disease.

“Improvements in participants’ pain self-efficacy, pain catastrophizing, coping through relaxation....”

—Kimberlee J. Trudeau, PhD, and colleagues

Participants in this program had improved outcomes in pain relief, awareness about their condition, and self-management behaviors, as well as improved mood and coping skills and better quality of life compared with controls with a similar level of RA pain at baseline.

“These improvements in participants’ pain self-efficacy, pain catas­ trophizing, coping through relax-

ation, and quality of life indicate that painACTION can be an important element of a comprehensive disease management program for people with arthritis pain. Further research is needed to determine which subgroups can be most effectively treated by an online intervention and to better understand why some dimensions changed after exposure to the treatment, while others did not. Pain­ACTION may help meet the public health need for arthritis education,” according to Kimberlee J. Trudeau, PhD, of Inflexxion.

Engaging Patients with RA in Their Disease Management One in every 5 adults in the United States is affected by arthritis, and in 2000, the US Department of Health and Human Services set a goal of disseminating arthritis education to more patients.

Self-management is a critical component in helping patients to learn how to identify, avoid, and manage their pain, but physicians typically do not have time to provide patient education of this nature.

Internet-based programs have been shown to improve outcomes among people with back pain and migraine.

The investigators developed and tested the online, interactive selfmanagement program for adults who suffer pain associated with osteoarthritis (OA), RA, ankylosing spondylitis, and other rheumatic conditions based on principles of Social Cognitive Theory (Bandura, 1997). The motto of the program is, painACTION “picks up where the office visit leaves off.”

September 2013

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The Program A total of 228 participants (mean age, approximately 50 years) were recruited via flyers and online posting. All participants had moderate-to-severe pain associated with RA, as reflected by a self-reported pain level of ≥4 in the previous week on the 0 to 10 Numerical Rating Scale. The experimental group comprised 113 patients who participated in painACTION, who were compared with 115 controls.

Approximately 68% of the participants were female, and approximately 44% were college graduates.

Approximately 53% of both groups had RA, 60% had OA, and 7% had other arthritic conditions.

Participants used painACTION twice weekly for 4 weeks, followed by 5 additional monthly booster sessions. The painACTION program included articles, lessons, and interactive tools to facilitate learning pain self-management skills.

Participants had significantly improved pain control at 1-month and 6-month follow-up, reduced pain ca­ tastrophizing at 6-month follow-up, and increased relaxation coping at 3-month follow-up. In addition, participants had improved patient perception of global change at 1-month, 3-month, and 6-month follow-up compared with controls.

By contrast, no significant differences between the groups were found in the effect of the intervention on pain awareness, the use of self-management strategies, pain level, and functioning. More research is needed to understand these effects, the investigators said. l

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ICD-10 Update

Transitioning to ICD-10…Continued from page 1 2014; Phase 3: Go Live Preparation, first quarter 2013 through third quarter 2014; and Phase 4: Postimplementation, fourth quarter 2014 through fourth quarter 2015.

Phase 1: Impact Assessment Your practice should already have completed the impact assessment. If you are behind schedule, you need to work hard now to catch up. The shift from International Classification of Diseases, Ninth Revision (ICD-9) involves serious challenges, including transitioning from a system of 13,000 codes to a system of more than 68,000 codes in ICD-10-CM. You may recall that the implementation of a new generation of the 9 electronic standards for the Health Insurance Portability and Accountability Act (HIPAA), known as the American National Standards Institute (ANSI) Version 5010 (v5010), is a part of this process. ANSI v5010 replaced the elec-

tronic transaction standards ANSI v4010/v4010A. Once ICD-10-CM goes into effect, any transactions that are not compliant with HIPAA

The shift involves serious challenges, including transitioning from a system of 13,000 codes to a system of more than 68,000 codes. (ie, not using ANSI v5010) will be rejected. The new codes will be structurally different from the ICD-9 codes (Table 1 and Table 2).

By now, you should have a steering committee in place or have devised a communication schedule involv-

Table 1. Structural Differences between Diagnostic Codes ICD-9-CM

ICD-10-CM

3 to 5 digits

3 to 7 digits

Digit 1, numeric

Digit 1, alpha

Digits 2 to 5, numeric

Digit 2, numeric Digits 3 to 7, alpha or numeric

ICD-9-CM indicates International Classification of Diseases, Ninth Revision, Clinical Modification; ICD-10-CM, International Classification of Diseases, Tenth Revision, Clinical Modification.

Table 2. Structural Differences between Procedure Codes ICD-9-CM

ICD-10-CM

3 to 4 digits

7 digits

All digits, numeric

Each digit, either alpha or numeric

ICD-9-CM indicates International Classification of Diseases, Ninth Revision, Clinical Modification; ICD-10-CM, International Classification of Diseases, Tenth Revision, Clinical Modification.

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RHEUMATology Practice Management

I September 2013

ing everyone in your practice who will play a role in implementing the new coding system. If you have not already done so, you should take the following steps as soon as possible: • Begin operational processes • Evaluate workflow (data and staff) • Identify how to improve workflow • Conduct a gap analysis • Modify your software and upgrade your hardware • Educate your staff

Phase 2: Preparing for Implementation Now is also the time for the staff to review the practice’s current procedures and improve upon them, making them more efficient and cost-effective. The newly provided codes were designed to ensure that the collected data reflect patients’ conditions more precisely, decrease claims rejections, and improve the benchmarking of data and public health records. Examine the systems, vendor contracts, and costs for both your electronic health records (EHRs) and practice management systems. Use the following questions as a guide through this process.

Are your contracts with payers ready for the move? You may need to review and update these contracts to pave the way for the move to ICD-10.

Will your current practice management system accommodate the change, or will you require a new system? Choose a software package that will accommodate the necessary changes. Review the problems your practice has experienced in the past 2 years and how they affected your practice and cash flow. Ask yourself what responses and issues you faced with your current practice management software vendor/customer support. How difficult was it to resolve any problems? What did

ICD-10 Update

it cost you in time, lost productivity, staffing, and overtime to “catch up” from having your system down for maintenance and upgrades?

Will the upgrade to the new system involve a fee? If so, how much will that cost? Will your vendor(s) provide the codes at no cost?

What is your vendor(s’) timeline for implementation, and when will they allow you to test your system?

You will need to know when the upgrade to your existing system will be complete or when the entirely new system will be available. When it is complete, you then need to know whether your vendor(s) will provide training for your practice, and if so, what the training will cost.

Have you begun to modify your templates? Remember to update your forms and superbills. The newer forms will, by necessity, be far more comprehensive and complex than the older forms.

Will your vendor(s) load your specialty specifically, or will all of the specialties be included in your system? Will diagnoses be searchable by partial terms, and will they include the coding guidelines, rules, and exceptions to the guidelines that your practice may encounter?

For example, when coding for malignancies, the malignancy will remain the principal diagnosis when the treatment is directed at the malignancy. However, if a patient is admitted for anemia associated with the malignancy and the treatment is exclusively for anemia, the code for the malignancy will be listed as the principal or first-listed diagnosis, followed by the code D63.0, Anemia in neoplastic disease.

Next Steps: • Contract with a consulting service • Redesign and reprint paper forms • Convert your data • Maintain a dual system until all

of the problems with the new system have been worked out • Purchase software, seek educational resources, and use mapping tools as needed to help with the transition • Anticipate decreased coding accuracy and work to solve those associated issues • Monitor coding from the point of implementation • Develop a communications plan in preparation for going live • Regularly update your senior executives

Looking at the positive side of the transition, once we are prepared, the higher level of specificity with which this coding system will allow us to code will paint a very clear picture for the insurance carriers and will clearly identify patients’ medical problems to justify the medical services performed.

Phase 3: Go Live Preparation Before you “go live,” be sure that any systems that are not working properly are corrected. Again, make sure you know what your vendor(s) will be able to do to help you with the transition. If you do not know for sure, ask your vendor(s) whether

September 2013

I

a mapping program will be provided. General Equivalence Mappings (GEMs) were developed to help you with the conversion, because ICD10 is more specific than ICD-9.1 GEMs are basically translation tools for not only payers and providers, but anyone working with coded data. Remember, the diagnostic codes have increased from some 13,000 to 68,069. Procedural codes have increased from 3824 to 72,589.

The GEMs can be used to convert your data from ICD-9 to ICD-10CM/PCS and back again (ie, forward and backward mappings, also known as crosswalks).

The GEMs will allow you to translate data for tracking quality, recording morbidity and mortality, calculating reimbursement, or converting an ICD-9-CM–based application to ICD-10-CM/PCS. They also can be used to help your practice convert payment systems, payment and coverage edits, risk adjustment logic, quality measures, and research applications germane to trend data. In cases where there is no translation between an ICD-9-CM code and an ICD-10 code, a flag will indicate “No Map.” One such example is ICD-9CM Procedure Code 89.8—Autopsy, for which there is no translation in ICD-10-CM/PCS. Next Steps: • Confirm with your vendor(s) that the needed upgrades are in place • Finalize all system changes from January through September 2014 • Complete testing • Conduct claims testing • Make any necessary modifications and reassign testing • Have a contingency plan in place

Phase 4: Postimplementation Reeducate your staff as necessary Continued on page 22

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21

ICD-10 Update

Transitioning to ICD-10…Continued from page 21 and continue to monitor all of your systems—cash flow, productivity, revenue, and coding accuracy.

Exceptions to the Rule As one would expect, there are several exceptions to the rule. One occurs in the etiology/manifestation convention regarding placement of the code, as well as the placement of the notes “use additional code” and “diseases classified elsewhere.” Certain conditions have both an underlying etiology and multiple body system manifestations owing to the underlying etiology. For such conditions, the ICD-9 coding convention requires that the underlying condition be sequenced first, followed by the systemic manifestation(s). Wherever such a combination exists, there is a “use additional code” note at the etiology code, and a “code first” note at the manifestation code.

These instructional notes indicate the proper sequencing order of the codes—etiology followed by manifestation.2 Another exception to the rule occurs with regard to syndromes.

When coding syndromes, it is important to follow the alphabetical index guidance. When there is no index guidance, assign codes for the documented manifestations of the syndrome.2 Looking at the positive side of the

ICD-10-CM/PCS transition, once we are prepared, trained, and on our way, the higher level of specificity with which this coding system will allow us to code will paint a very clear picture for the insurance carriers and will clearly identify patients’ medical problems to justify the medical services performed.

All of this assumes, of course, that the provider is well educated on this system and is utilizing it to its fullest potential. The level of detail required should result in decreased requests from insurance carriers for medical records which, in turn, will allow the staff to work on other tasks that are critical to the daily operations of your medical practice.

Next Steps: • Monitor the impact of ICD-10 on reimbursement • Meet with your staff regularly to share information • Monitor the functionality of your practice management and EHR systems • Monitor coding accuracy and productivity • Train or retrain your staff as required • Monitor your case mix • Resolve payment issues • Communicate with payers

Conclusion A significant amount of concern

and resistance remains in accepting ICD-10-CM/PCS. However, it is coming, and time is ticking away. It is better to take a look at things now, to take the first step and have the first meeting to see who in your organization knows anything about ICD10-CM/PCS. Your first step may be to send someone to a seminar or assign someone to spend the time to research the basics online.

To fully participate in this system, it is highly recommended that you fully understand the coding guidelines. Although some of the guidelines have been retained, there are exceptions—particularly with the new combination codes.

It is important to remember that the ICD-10-CM codes will be used by all medical providers. The ICD10-CM/PCS codes are only for inpatient hospital procedures and are used only by the hospitals. You must provide a full description of a procedure or diagnosis. It would be a grave error to truncate these codes, as we are attempting to seek the highest level of specificity. If your vendors download only partial codes, the data will not serve its purpose.l l

References

1. General Equivalence Mappings. www.cms.gov/ Medicare/Coding/ICD10/downloads/GEMS-Cross walksBasicFAQ.pdf. Accessed April 17, 2013.

2. American Medical Association. CPT® 2013 Professional Edition. 2013; American Medical Association. Last modified May 2, 2013.

Share your knowledge and expertise!

Contribute an article to RPM! We are accepting articles from our readers for future issues of Rheumatology Practice Management. If you are interested in submitting an article, e-mail Lisa Neuman, Managing Editor, at: lneuman@the-lynx-group.com for more information and author guidelines.

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RHEUMATology Practice Management

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Call for submissions

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Do you have a practice management solution to share

In your background as a rheumatology practice manager, it’s likely there’s one business experience—and maybe more—that practice managers across the nation would want to read about.

High-interest topics include: the solution you found to a practice management challenge, reimbursement, your experience with EMR, Medicare audits, a memorable encounter that shaped the way you now run your business and/or practice medicine, or how you successfully integrated ancillary products and services into your practice as a revenue generator.

Send us your ideas!

Submit a 1000- to 2000-word original article, previously unpublished and submitted exclusively to Rheumatology Practice Management, that your fellow practice managers will want to read.

Submit to: Lisa Neuman, Managing Editor E-Mail: lneuman@the-lynx-group.com RPM_73113

Don’t Face the Maze of Changes in Rheumatology Alone

NORM Keeps You Informed National Organization of Rheumatology Managers

NORM’s mission is to provide rheumatology managers, administrators and managing physicians countless opportunities to network with colleagues through our listserv and annual conference.

At NORM, our goals involve addressing, educating, distributing, and functioning as a conduit for rheumatologic practice management needs and expertise.

“NORM, by far, surpasses the benefits of any other organization I have ever belonged to. Through the listserv, NORM members willingly assists each other by providing solutions to everyday issues that arise while managing a rheum practice. We share experiences, ideas, protocols and procedures specific to a rheumatology practice. The annual NORM conference in September is definitely the icing on the cake as we all come away with practical ideas and tools we can implement.” Mary Jo Wideman, RN, BSN, Practice Manager

Do you have questions about coding, biologics, insurance carrier denials or personnel issues? Join NORM to help find your answers. Are your questions state specific, MAC specific or national coverage issues? NORM offers rheumatology managers the opportunity to connect across the Nation. Through our listserv you receive expert advice from professionals in rheumatology!

Join NORM and network with experienced managers through our listserv, gain access to our members only section which contains sample practice forms, job descriptions, and other documents that have been shared on this listserv, a list of our members, and in the future educational resources. NORM also hosts webinars throughout the year to continue supporting the education of our members.

Membership is open to rheumatology professionals including physicians and those who hold a management position in a rheumatology practice.

Save the Date for our 2014 Annual Conference September 12 & 13, 2014 ~ Louisville, KY

NORM ~ www.normgroup.org ~ info@normgroup.org