Rheumatology Practice Management December 2013

PROCESS IMPROVEMENTS TO ENHANCE PATIENT CARE™ DECember 2013

www.RheumatologyPracticeManagement.com

Volume 1 • Number 2

PRACTICE MANAGEMENT

Reflections on the NORM 2013 Annual Conference

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

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

As tired and travel-weary as I was, my mind was still in sponge-mode—ready Continued on page 10

From the Editor

Sharing Our Success

™

By Iris Nichols President, National Organization of Rheumatology Managers

A

fter months of preparation, the National Organization of Rheu­ matology Managers (NORM) 8th Annual Conference was held the weekend of September 13-14, 2013, in Long Beach, CA. This year’s conference brought together managers from 150 practices in 35 states.

We had our first practice from Hawaii represented this year.

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

NORM Meeting Proceedings

Healthcare Reform: Stakeholder Integration Is Key to Improving Care

By Sandra Paton

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

A considerable part of the healthcare costs is spent on chronic diseases in the United States. For baby boomers, this often means 2 or more chronic illnesses.

Continuing or adding to the current cost trend would be devastating to the US Continued on page 13

In partnership with

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

Genentech Rheumatology Access Solutions

We Focus on Access So You Can Focus on Health Patient assistance offerings* through Genentech Rheumatology Access Solutions can help your patients obtain the therapy prescribed, regardless of their ability to pay.

1

Commercially insured patients

We offer referrals to the Genentech Rheumatology Co-pay Card Program

2

3

Publicly† or commercially insured patients

Uninsured or rendered uninsured patients

We offer referrals to the Genentech® Access to Care Foundation

We offer referrals to co-pay assistance foundations‡

Additional programs are available for certain patients.

We have supported co-pay assistance foundations with more than

$932 Million §

in donations since 2005.

Since 1985, Genentech has donated

$3.5 Billion ||

in free medicine through GATCF and other product donation programs.

For more information visit Genentech-Access.com/Rheumatology.

Or to speak live with one of our dedicated Specialists, call (866) 681-3261 from 6 a.m.–5 p.m. PT, Monday through Friday.

Each program has its own criteria for patient eligibility, including financial eligibility.

Includes Medicare, Medicare Advantage, Medicaid, TRICARE and other public assistance.

Genentech does not influence or control the operations of these co-pay assistance foundations, but Genentech Rheumatology Access Solutions can assist patients in navigating the process of seeking co-pay assistance by making an appropriate referral based on a patient’s diagnosis and by assisting with the application process. We cannot guarantee co-pay assistance once a patient has been referred by Genentech Rheumatology Access Solutions. The foundations to which we refer patients each have their own criteria for patient eligibility, including financial eligibility. § Amount is approximate pending final financial audit confirmation; data published in March 2013. || GATCF donation value is based on most current forecast. * †

Access Solutions

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The Access Solutions logo is a registered trademark of Genentech, Inc. ©2013 Genentech USA, Inc.

So. San Francisco, CA

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In This Issue

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

PROCESS IMPROVEMENTS TO ENHANCE PATIENT CARE™ DECember 2013

PRACTICE MANAGEMENT

Sharing Our Success...........................................................................................1 ™

By Iris Nichols

Perspective

Production Manager Melissa Lawlor

By Jay Salliotte

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

Reflections on the NORM 2013 Annual Conference................................1 NORM Meeting Proceedings

Healthcare Reform: Stakeholder Integration Is Key to Improving Care..............................................................................................1

By Sandra Paton

NORM “Surfs” Through Successful Annual Conference......................11

By Sandra Paton

Communicating a Leadership Persona................................................15 Presented by M. Sean Limon, PhD

Building Organizational Culture in a Rheumatology Practice............25 Presented by Paul L. Caldron, DO, FACP, FACR, MBA

Continued on page 4

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

Volume 1 • Number 2

From the Editor

Editorial Assistants Jennifer Brandt Cara Guglielmon

The Lynx Group President/CEO Brian Tyburski

www.RheumatologyPracticeManagement.com

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-chang­ ing business of rheumatology. Rheumatology Practice Management will offer process solutions for members of the rheu­ matology 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.

December 2013

I

www.RheumatologyPracticeManagement.com

I

3

In This Issue

Continued from page 3

NORM Meeting Proceedings

Social Media and Online Reviews—How to Take Control of Your Reputation without Trying to Be Everywhere at Once..............................................................................................................27 Presented by David Griner

HIPAA Omnibus Compliance—You Can Succeed.................................................................................30 Presented by Karen Gregory, RN

And Your Point Is?........................................................................................................................................34 Presented by Meryl Rose, CSP

2013 ACR Meeting Highlights

Examine How the Affordable Care Act Will Impact Your Practice.......................................................36

By Wayne Kuznar

Additional highlights from the 2013 ACR meeting will appear in the next issue.

To submit an article, contact Lisa Neuman at lneuman@the-lynx-group.com.

Articles should be 1000 to 2000 words, and can discuss any aspect of managing a rheumatology practice.

Editorial Advisory Board Editor-in-Chief Iris Nichols

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

Ana Reyes-Cartagena

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

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

Kyle Harner, MD

Helen Hinkle

Linda McKee

Mark Post

Jay Salliotte

Practice Administrator Rheumatic Disease Associates Ltd Willow Grove, PA

I

Allyson D. Eakin, RN, OCN, CCM

Practice Administrator Premier HealthCare Associates, Inc Richmond, VA

Nancy Ellis

Practice Administrator Greenville, SC

4

Marjorie Collings

RHEUMATology Practice Management

Carolina Arthritis Center Greenville, NC

Office Administrator Rheumatology Associates of South Texas San Antonio, TX

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

I December 2013

Business Manager Advanced Rheumatology Lansing, MI

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

•

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

•

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 GlaxoSmithKline group of companies.

All rights reserved. Printed in USA. BN2289R0 August 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

From the Editor

Sharing Our Success...Continued from page 1 for a better way of identification and this proved to be very suc­ cessful. Organizational leaders were able to identify all of the partici­ pants and then network appropri­ ately. By coming together as peers, we were able to share information.

Sharing, as a noun, is defined as using or enjoying something with others. We were probably intro­ duced to the concept of sharing in our childhood throughout our pre­ school years, but as adults it takes time to become comfortable with that process. NORM serves as a sharing conduit by which members from all aspects of the rheuma­ tology practice come together to share their thoughts and expertise.

Some of the benefits gained through sharing will improve clinical oper­ ations, enhance compliance, and streamline patient flow throughout the clinic by implementing defined procedures and protocols.

Sharing information through this conference has moved far beyond the desire of our parent organization, the Coalition of State Rheumatology Organizations (CSRO). CSRO is a group of state and regional professional rheuma­ tology societies that was formed to advocate for excellence in rheumat­ ic disease care and to ensure access to the highest quality care for the management of patients with rheu­ matic and musculoskeletal diseases.

This physician-based entity had the wisdom to create an organization that would afford their mangers the same professional opportunity at a national level. Together the phy­ sician and manager can and have partnered in developing a “gold standard practice.”

On NORM’s website, www. normgroup.org, in the “About” section, it states, “NORM provides rheumatology practice managers,

administrators, and managing phy­ sicians countless opportunities to network with colleagues through its ListServ and annual conferences.

The varying levels of expertise among our many members along with the diverse sizes and services of the practices they represent offer a myriad of benefits to the overall membership. NORM has succeeded in developing a network of rheuma­ tology professionals, one that has improved our lives personally and professionally. Together we face and conquer the many operational chal­ lenges of our practices. We have achieved much and are enthusiastic about our continued future growth and progress.” This year’s confer­ ence personified that commitment to excellence in the management of rheumatology practices.

As our specialty continues Iris Nichols to evolve and change, we must remain engaged and networked to remain strong.

The program began with a moti­ vational speaker who presented a lighthearted approach to our man­ agement roles. “Gladys Friday” put a different twist on the sharing of information, with characters such as “Ima Gossip.” The audience was able to laugh but also able to identify with the imaginary characters that are all too real in most of our offices.

Programs in areas such as health­ care reform, communicating a lead­ ership persona, “spying the lie,” the

December 2013

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Health Insurance Portability and Accountability Act, interviewing skills, and finding leverage in payer negotiations all contributed to shar­ ing the skills necessary to meet the challenges in our healthcare envi­ ronment. These programs were help­ ful for the new managers as well as the seasoned ones. The program evaluations were very supportive of the content and members found there is always work to be done as we strive to keep the puzzle pieces of our business connected.

As our specialty continues to evolve and change, we must remain engaged and networked to remain strong. Education is the only means for us to do so. Our NORM Education Committee (NEC) premiered the first of what will become our educa­ tion modules at the conference. This committee was formed as a result of the need of sharing ideas, skill sets, and basic operation management tools for rheumatology practices.

The NEC is comprised of a diverse group of managers from different practice sizes and styles. We are very excited about the content and design of this platform and everyone will benefit from this product. The out­ line of protocols and procedures can be customized to your practice style.

The first module is almost complete and will launch in January.

I believe that sharing informa­ tion through educational oppor­ tunities will be the success and viability of our specialty in the coming days, months, and years.

The partnership between NORM and Engage Healthcare is an ave­ nue by which this information can be passed on to managers and phy­ sicians. As we close out 1 year and look forward to the next, I wish you all great success in sharing, and hope to see you all at next year’s NORM conference. l

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Perspective

Reflections on the NORM 2013...Continued from page 1 to soak up anything useful, action­ able, and inspiring. Knowing neither this author nor the context of the poem, I pondered. Surely he was not referring to practice management or the state of healthcare, but still the words resonated. Then it hit me. For me, this poem is about us and our roles as leaders in our organizations.

We are the stewards of the soil (our practices) and what grows from that soil, if anything, is a direct result of the care we provide.

Do we nurture our soil? Do we water it, weed it, fertilize it, and plant in it? Or do we pave over it for the sake of consistency and convenience?

How do our patients experience our soil? Are we a hard, dull, paved lot, void of life? Are we a paved lot over­ grown with weeds and riddled with dangerous cracks and potholes? Or are we a colorful field of grass and flora? Perhaps we are a young forest growing and reaching for the stars?

These are the questions we should be asking about our practices.

If you are the caretaker of a prac­ tice that is like a breathtaking forest of Sequoia trees, you can stop read­ ing now. But, if you are like me, we know there is always more to do. We can always grow taller, and we never stop reaching toward the sky.

Helping us to move forward in our cultivation of employees and the work environment were several great sessions at the NORM confer­ ence. Some of the excellent sessions

are covered in this issue. Dr Sean Limon’s breakout session on perfor­ mance feedback was very helpful.

Not only did he address the common problems with performance feedback, he set some great guidelines for doing it effectively with positive impact. Dr Limon’s general session presentation on leadership was also very helpful for

As practice managers, we are the Jay Salliotte people who are ultimately accountable for billing, compliance, information technology, marketing, contracts, credentialing, customer service, and the financial health of the practice. evaluating our practices and the lead­ ership style of our colleagues. I also really appreciated Dr Paul Caldron’s breakout session on building the prac­ tice culture. Had time allowed, Dr Caldron probably could have easily expanded his presentation for sever­

al more hours, because he touched on some absolutely essential topics.

Topics included working in a ser­ vice business, setting and meeting expectations for our customers, and defining what workplace culture is and why we should pay attention to it. These are the building blocks for a foundation and framework within which a good practice can thrive and weather any storm.

Of course, as practice managers, we are the people who are ultimately accountable for billing, compliance, information technology, marketing, contracts, credentialing, customer service, and the financial health of the practice. All of these things are extremely important, and they are not small tasks. But, we should feel equally responsible for the growth and development of our practice and our staff. I believe we should cultivate our practice and employ­ ees through leadership and inspi­ ration rather than pave over them with an overabundance of rules and mistrust. We need to define our work environments, build and mod­ ify its framework, and set the tone before someone else does it for us, because we all know where that story ends.

How will you set aside time to cul­ tivate your soil? What will you plant?

What tools do you need? What pos­ itive changes can you commit to before NORM meets again next year in Louisville, Kentucky? l

Nat ion a l O r ga n iz at ion of o R he um atolo g y Man a gers

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NORM Meeting Proceedings

NORM “Surfs” Through Successful Annual Conference

By Sandra Paton

Long Beach, CA—The National Organization of Rheuma­ tology Managers (NORM) held its 8th Annual Conference on September 13-14, 2013 in Long Beach, California. The conference—attend­ ed by 150 managers, administrators, and physician managers of private rheumatology practices—addressed various healthcare challenges, from the Affordable Care Act (ACA) and all of its implications, to strat­ egies surrounding social media and private practice, communicating to strengthen leadership positions, and building a healthy practice culture in the process.

The theme of the conference was “Surfing Through Rheumatology,” likening the healthcare environ­ ment as one that is changing, much like the surf of the ocean—some­ times smooth sailing with very few ripples, and other times facing hur­ ricane-strength winds when it comes to issues such as buy-and-bill, mean­ ingful use requirements, accountable care organizations, in-house pharma­ cy, healthcare reform, and shrinking reimbursement, just to name a few.

One of the goals of the conference was for practice managers to spend time with colleagues networking, sharing experiences, and learning from the offered programs to take new ideas back to their practices.

On Saturday, after breakfast in the exhibit hall and the introduction of the candidates up for election to the NORM Executive Board, it was time for the keynote address.

John Hoffman, Senior Director of Health Policy, Advocacy, and Quality for the Strategic Group at Johnson & Johnson North America Pharmaceuticals, the conference’s keynote speaker, provided a snap­

shot of healthcare reform and out­ lined some of the difficulties it faces.

M. Sean Limon, PhD, oral com­ munication coordinator for the Center for Management Communi­ cation at the University of Florida’s Warrington College of Business Administration in Gainesville, and communications consultant to

One of the goals of the conference was for practice managers to spend time with colleagues networking, sharing experiences, and learning from the offered programs to take new ideas back to their practices.

Disney, Skanska, CSX, Rayonier, and others, examined the impor­ tance of communicating to convey a leadership persona on the job. He defined what leaders do, how they look, and what makes a good leader, including the nonverbal behaviors of leaders. He further defined how leaders build relationships and how they solve problems, how they com­ municate, and how they listen. The process, he noted, involves winning employees over and helping them to understand your point of view rather than dictating it. He offered advice on nonverbal communication and how to convey leadership in the process. Because every day is a blank

slate, we have the opportunity to rework and reorganize our strategies and our messages. Thus, he urged attendees to build confidence in employees rather than push home a point.

Meryl Rose, an author, lecturer, and communication strategist with her own company, Speak Strong, offered even more tips on communi­ cating to make a point and how to stay on topic. She urged the prac­ tice managers to use workflow tools to find their points, help organize the information surrounding their points, and effectively share their points. Her motto: “Say what you mean and mean what you say with­ out being mean when you say it.”

David Griner, the founder and president of Ishmael Digital Content, helped the attendees surf through various websites to examine the impact of reviews—both negative and positive—on their practices. He reviewed the pitfalls and the bonuses of Yahoo, RateMDs, Vitals, Google, Microsoft Bing, Facebook, Yelp, and Angie’s List, and offered tips on han­ dling negative reviews.

He noted that encouraging re­ views is a good way to build posi­­ tive reflections of your business and urged practices to encourage patients to share and review their experiences while they are still in the office, as they are more likely to write positive reviews when their experiences are fresh. They don’t often take the time to do so when they are pleased. But an angry patient is likely to remem­ ber a bad experience and make a note of it in a negative review.

Phil Houston, CEO of QVerity and a legendary CIA interrogator, offered tips on how to “spy the lie” during interviews. An experienced Continued on page 12

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NORM Meeting Proceedings

NORM “Surfs” Through Successful Annual...Continued from page 11 polygraph examiner, he pointed out that the device requires the examiner to have skills, to ask the right kind of questions, and to know when to push harder for the truth.

Without human intervention and perception, he noted that the device is worthless.

He provided 6 cues for spotting a liar and offered caveats for inter­ viewers. He further emphasized the importance of not being adversar­ ial during interviews and reward­ ing cooperation. The people you hire today will be responsible for ensuring that all of your systems work smoothly. In this healthcare environment, focus is important.

Having the right people on the job will ensure that the job gets done correctly. Remember, the person you hire today might be the person charged with the responsibility of ensuring that all breach exclusions are documented, who will go to bat to ensure that patients in your practice have improved coverage and access to care, or who will see to it that your online reviews are sufficiently monitored. This person might be responsible for ensuring that false-negative reviews are dealt with politely but firmly, all in the best interests of your practice. The person you interview today could become the leader your organization needs tomorrow.

Karen Gregory, RN, director of compliance and education at Total

Medical Compliance, where she is responsible for the development and supervision of compliance pro­ grams within the organization, dis­ cussed what constitutes a breach of patient privacy and the importance of having an action plan if sensitive information is lost or stolen. She also examined dealing with business

In this healthcare environment, focus is important. Having the right people on the job will ensure that the job gets done correctly. associates or subcontractors whose patient files might have been com­ promised and the importance of doc­ umenting breach exclusions, com­ pleting a risk analysis, and having a plan in place regarding how business associates will be made to respond in the event of a breach.

Paul H. Caldron, DO, FACP, FACR, MBA, a rheumatologist in Phoenix, AZ, addressed practice managers on the topic of organi­ zational culture, distinguishing it from individual culture and how it applies to rheumatology. He noted that organizational culture

is a function of company leadership and staff, plus internal and external pressures. He observed that culture requires concentrating on the pos­ itive and laying aside the negative.

He presented a case study illustrat­ ing a failing practice and demon­ strated how it was a function of poor management and the authoritarian mind-set of 1 physician and his assistant, who was allowed to make decisions that should not have been within her purview. He urged prac­ tices to establish a clear chain of command and to establish strong ground rules for civility and group and personal safety.

The conference also includ­ ed breakout sessions, networking breaks in the exhibit hall, and reception and dinner events where attendees could relax a bit and meet new colleagues to build rela­ tionships.

The 2014 NORM Board of Directors was elected, and the officers are: Iris Nichols, presi­ dent; Ethel Owen, vice president; Catherine Evans, secretary; Walter “Rai” McElroy, treasurer; and members-at-large Donnie Craig, Karen Grace, Jim LaBorde, David Rothhaas, and Andrea Zlatkus.

Next year’s conference will be held September 12-13, 2014, in Lexington, KY. Details of the meeting will be published in future issues of Rheumatology Practice Management. l

Attention NORM Members Membership dues for 2014 are now due.

Visit www.normgroup.org/Join.aspx to learn about the benefits of NORM membership, find out how to join, and pay your 2014 membership dues.

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NORM Meeting Proceedings

Healthcare Reform: Stakeholder Integration…Continued from page 1 economy and must be addressed.

At the National Organization of Rheumatology Managers (NORM) 8th Annual Conference, John Hoffman, Senior Director of Health Policy, Advocacy, and Quality for the Strategic Customer Group at Johnson & Johnson North America Pharmaceuticals, delivered the Keynote Address, examining the changes that will inevitably take place with healthcare reform, under the Affordable Care Act (ACA), and what they mean for clinical practices.

Healthcare must reflect quality, and penalties must be imposed when care is not delivered properly the first time. The use of value-based purchasing and value-based modifi­ ers can help to improve quality care and reduce waste.

Today, new stakeholders are tak­ ing on greater roles in healthcare.

Payers are becoming more involved in the provision of care, and patients are taking on greater roles in the management of their own health and becoming more informed and involved in the decision-making process. Implementation of the ACA is now taking place, with new options and a new focus on quality care and costs.

Exchanges are being set up to allow competitive bidding between insurance companies so that afford­ able options can be offered to indi­ viduals who are mandated by law to have medical insurance and to companies required to provide insur­ ance. Although it is not yet known how many people will choose to go into the exchanges, each state must create at least 1 exchange. If a state does not create an exchange, the federal government will do it for that state. Approximately one third of the states still want no part of this process. States can also partner with the government and allow exchang­ es to be co-run.

Independent Payment Advisory Board The Independent Payment Advisory Board (IPAB) consists of individuals who will determine how Medicare spending is paid and delivered. The IPAB was instituted to cut spending, and it has been called “the sustainable growth rate on steroids.” It will have the power to make recommendations that will become law, requiring a two thirds vote in Congress to undo such laws.

The IPAB has unbridled power to make such decisions. If the IPAB survives, it is supposed to kick off in 2015 and 2016.

Improving the health of the population overall requires examining costs and improving the quality of care. The least costly alternative is not always the best care or the least costly in the long-term. The ultimate goal must be to provide the best care, for the best value.

Value-Based Modifier Value-based modifier is a mech­ anism whereby the government is seeking to incorporate quality, not quantity, into the Medicare pay­ ment system. It will adjust Medicare physician fee schedule payments.

This goes into effect in 2015 for practices that have 100 physicians or more, and in 2016 for practices

with 10 to 99 physicians. All other physician groups will be affected by changes to the Medicaid payment system at a later date.

Fiscal Cliff Deficit Reduction If healthcare costs continue to grow at current rates, the share of health­ care in the GDP is projected to reach 18% by 2021. Eliminating the US deficit would require cutting the costs associated with medical care. This could be ameliorated if tort reform is enacted. The ACA is intended to help control costs, but this must be done with an eye on quality care and value, not cost alone.

Aligning Stakeholders Each healthcare stakeholder has a different perspective. It is important to align all stakeholders toward a unified goal to improve the quality of care. To do that, the following steps must be taken: 1. Alignment on quality metrics.

Anyone involved in quality met­ rics must be involved in clinical care. Physician and patient groups must become involved. Practice managers are urged to become involved and join committees to recommend quality measures and provide public commentary.

2. Alignment of incentives and accountability. The majority of healthcare in the United States is centered on independent hospi­ tals and physicians. These 2 fac­ tions must become aligned during the transition.

3. Improvement of coverage and access to care. As for health insurance coverage, although payers provide coverage to care, this does not only mean access for patients. For example, payers provide coverage for certain drugs, but often only 40% is covered by insurance and the rest is paid by copay or coin­ surance, which limits access for Continued on page 14

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NORM Meeting Proceedings

Healthcare Reform: Stakeholder Integration…Continued from page 13 many patients. Increased coverage must lead to increased access to care.

4. Shared decision-making. Physi­cians must have a voice in this process.

5. Improve value propositions. Pharma­ ceutical companies must provide value propositions, not just related to their product, but also wrap­ around services.

6. Attract more customers. This, too, will require an aligned approach to care.

Major Drivers Toward Improving Care Patients, providers, payers, and employers should be the major drivers in this process. Coverage alone is insufficient; access to care must be improved. For example, the Cleveland Clinic has a new Chief Executive Office (CEO), but instead of “Executive” in the CEO, the “E” stands for “Experience,” to ensure that patients are treated in an excellent way. This includes ensur­ ing that floors are clean, the garage service attendants are friendly, and whatever else patients may notice is satisfactory.

Improving the health of the pop­ ulation overall requires examining costs and improving the quality of care. The least costly alternative is not always the best care or the least costly in the long-term. The ultimate goal must be to provide the best care, for the best value.

Making these changes will require time for the old and new systems to evolve and coexist. All voices involved in patient care must speak out on these matters. This should not be a choice, but a mandate.

Health Insurance Exchanges The health insurance exchange is intended to promote health insur­ ance competition and increase coverage. The exchange brings

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together private health insurance companies and the government insurance option to compete for business among individuals and small businesses. To participate, insurers can no longer exclude any­ one with a preexisting condition.

The federal government is running all or part of the exchanges in 36 states. The remaining 14 states are running separate marketplaces with their own software.

In the end, practices will determine their clinical guidelines, but they need to get involved in that process. Providers must be a part of the solution and a part of the decisionmaking process in patient care.

The state exchanges require that at a minimum, 10 essential services must be covered by each plan. Although each benchmark plan varies from state to state, each state must have the same minimum criteria.

Some practices are closed to Medicare patients and some practic­ es offer limited service to Medicaid patients. It is currently not known if practices must or will accept exchange patients. The exchanges are a virtual marketplace—a place for one-stop shopping. In concept, patients should be able to receive affordable care. Those who pay more will get more coverage, based on the bronze, silver, gold, or platinum

RHEUMATology Practice Management

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level of insurance plan. However, some plans have set a very high outof-pocket cost for the patient, which again, will limit access to care for many patients.

The pharmaceutical industry is helping where it can with copay assistance through foundations and copay assistance programs to cover some of the cost of out-of-pock­ et expenditures for drugs. Increased utilization would help offset some of that cost, but this will decrease prof­ itability, which in turn will affect innovation and research and devel­ opment of new therapies.

Patient eligibility can also be an issue for practices. There is a 90-day grace period, but if during that peri­ od a patient’s plan is not paid, how will a practice know which patients are qualified? To deter­ mine your state’s position on the issue, go to healthcare.gov, where you can also enter specific patient information. Two other places to seek state-specific information on exchanges and Medicaid are the Kaiser Family Foundation (kff.org) and State Refor(u)m (www.state reforum.org), which will be posted on the NORM listserv.

Conclusion Implementation of the ACA begins on January 1, 2014, for the individual mandate. The employ­ er mandate has been delayed to January 1, 2015. In the first few years, the penalties for those not selecting insurance will not be high, but eventually, they will go up to 2% of income.

These are early days in the imple­ mentation of the ACA. In the end, practices will determine their clini­ cal guidelines, but they need to get involved in that process. Providers must be a part of the solution and a part of the decision-making process in patient care. l

NORM Meeting Proceedings

Communicating a Leadership Persona Presented by M. Sean Limon, PhD Oral Communication Coordinator, Center for Management Communication, Warrington College of Business Administration, University of Florida, Gainesville, FL

Long Beach, CA—How do we communicate a lead­­er­ship persona?

What is it that leaders do and how can we look like leaders? What makes a good leader? When you think of a good leader, who do you think of? What makes him or her a good leader? At the National Organization of Rheumatology Managers 8th Annual Conference, M. Sean Limon, PhD, posed these questions to begin his presentation and to determine the attributes of a leader, including his or her nonver­ bal behaviors.

He defined leadership as a con­ tinuing process whereby 1 individ­ ual influences a group of individu­ als to do something, getting them to believe in a particular message.

This process, he explained, involves goal attainment. He cautioned that there is a difference between man­ aging and leadership. “People don’t want to manage. They want to lead other people and/or organizations to a common goal or objective. Leaders want to take others where they want to go.” And to do this, he noted, they must have specific attributes.

Leaders Are Trustworthy Leaders must be trustworthy.

You must be able to believe what they say. A person who lies, who bends the truth, who is found to be untrustworthy will be found out eventually and will lose followers.

Leaders Are Committed Leaders must be committed to the organization, to the product, to the people. They are committed to their employees, and the people know it.

Just as good leaders in the military are committed to their soldiers, the sol­ diers know it and respond accordingly.

Leaders Are Competent Leaders know how to do things.

They know how to get things done.

They don’t have to be the best at anything, but they must know how to do it. Leaders usually surround themselves with competent people who will help get the job done.

he described how he left his hotel room, where he had access to free coffee, to go down­ stairs for a $3.00 cup of Starbucks coffee in the lobby.

Leaders Communicate Good leaders communicate well, often, and clearly. They communi­ cate enthusiasm in a manner that others understand. For example, Howard Schulz, the chairman and CEO of Starbucks, communicates with his staff consistently. And he communicates his enthusiasm for the brand.

Leaders Solve Problems, and They Have a Vision Good leaders like to solve prob­ lems and have the vision to do it.

Think of Apple’s Steve Jobs and the iPhone. If an employee has an idea, acknowledge it. If you see a prob­ lem, address it and work on how to overcome it. Then, make it happen.

Leaders not only have a vision, they are eager to share it and include oth­ ers in making that vision a reality.

Leaders Listen Good leaders listen and react to what they hear. Don’t ask for feed­ back and do nothing with it. If an idea makes sense, adopt it. A top seller on eBay did not like a particu­ lar policy. Meg Whitman, the CEO of eBay, found out about it, flew out to the seller, and sat with him for an hour to discuss the problem and found that he made sense. She not only listened, she did something about it, and changed the problem­ atic policy.

Leaders Are Optimistic Good leaders are optimistic and convey it to the rest of the organi­ zation. They like to see their visions through and make things happen.

When Starbucks’ Howard Schultz went to Italy and tasted the strong coffee they drank, he thought there would be a market for it in America.

He was mocked for the idea, but he stuck with it. Dr Limon bore witness to the success of the brand when

Leaders Care and Build Relationships If people feel you care about them as human beings, as employ­ ees they will go the distance for you. Good leaders praise people, shake hands, get to know people’s names. If the workers do some­ thing well, good leaders seek them out and acknowledge them. Leaders engage in a certain style of commu­ nication that Dr Limon summed up in the following points: 1. Keep it simple. Everyone in your organization must understand you and your vision. “If you use language beyond them or that confuses them, they won’t be able to help you realize your vision. It’s all about commu­ nication. You should speak in a language that a high school student would understand,” noted Dr Limon.

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NORM Meeting Proceedings

Communicating a Leadership... Continued from page 15 2. Be optimistic. When Steve Jobs talked to his employees about the iPhone, he started with a rousing message: “Today, we are going to revolutionize the telephone industry….We are going to make this happen.”

Those powerful words galva­ nized the workforce.

3. Be truthful. Tell people the truth. Outline the situation as it is. People know when you’re lying, exaggerating, or sugar­ coating a situation. Good lead­ ers are honest; they will not let their employees fail.

4. Speak emphatically. Be fired up.

Show passion.

5. Be specific. Focus on your mes­ sage. Give details wherever possible.

6. Communicate often. Reinforce the message you are trying to communicate. Routinely com­ municate with everyone on the team and everyone involved in the vision.

7. Be honest. This goes beyond speaking the truth. You must be honest with your employees.

Good leaders don’t skirt the issues. They treat their employ­ ees as equals and will not let them fail. If something is going

wrong, give details and seek solutions.

8. Use declarative statements. Elim­­ i­nate these 4 phrases: I hope, I feel, I believe, I think. These words detract from your state­ ments. Saying “I think this budget will work” will not in­ spire your employees. Leaders

People don’t want to manage. They want to lead other people and/or organizations to a common goal or objective. Leaders want to take others where they want to go.

—M. Sean Limon, PhD

don’t hedge with such phrases.

They tell you where they are going and what they see.

Nonverbal Behaviors of Leadership Strong, confident leaders look people in the eye. They maintain meaningful eye contact. If you are making a presentation, do you look at the screen or the monitor all the time? Rudy Giuliani looked at peo­ ple all the while he spoke. Leaders also project their voices 2 notch­ es above their normal voice. They speak with power, which helps them make their point.

The way you stand or sit says a great deal about who is really in charge and who is really the leader in the room. Take up space. Don’t contract or be constricted. Doing so will make you look less confident.

Keeping your hands together at your groin makes you appear weak; in fact, it is one of the weakest stanc­ es you can take, as it makes your shoulders slump—a sign of submis­ sion. Keeping your hands clenched in fists is also constricted, making the speaker appear less powerful.

Keeping your arms across your chest makes you seem closed off.

Your feet should be roughly shoul­ der length apart. Use gestures when you speak. “Face your audience, face your employees. Be a strong leader,” Limon advised. l

SAVE THE DATE Next year’s NORM conference will be held September 12-13, 2014, in Lexington, KY—see page 29 in this issue.

Registration details will be published in future issues of Rheumatology Practice Management.

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Drop after drop–

New for your adult patients with moderately to severely active rheumatoid arthritis (RA), in combination with methotrexate (MTX)

Introducing SIMPONI ARIA ®

™

Changing the infusion experience

• Short infusion time: 2 mg/kg administered over 30 minutes every 8 weeks after starter doses at Weeks 0 and 41 • Re-envision infusion: reconsider infusion therapy for your biologic-ready patients with moderately to severely active RA

The only infusible, fully human anti-TNF monoclonal antibody available1

Selected Important Safety Information Serious and sometimes fatal side effects have been reported with SIMPONI® ARIA™ (golimumab), including infections due to tuberculosis, invasive fungal infections (eg, histoplasmosis), bacterial, viral, or other opportunistic pathogens. Prior to initiating SIMPONI® ARIA™ and periodically during therapy, evaluate patients for active tuberculosis and test for latent infection. Lymphoma and other malignancies, some fatal, can occur in adults and children. Other serious risks include melanoma and Merkel cell carcinoma, heart failure, demyelinating disorders, hypersensitivity reactions, and hepatitis B reactivation.

Prior to initiating SIMPONI® ARIA™, test patients for hepatitis B viral infection. Please see related and other Important Safety Information on following pages.

In moderately to severely active RA

When patients are ready for a biologic, consider SIMPONI® ARIA™ • Significant ACR20 response at Week 14, with rapid onset as early as Week 21,2 • Significant inhibition of the progression of structural damage at Week 24, as measured by total vdH-S score1,3 • A demonstrated safety profile in a clinical trial1

ACR20 response rates over time1,2 Week 2 Week 14 (primary endpoint) B:11.125 in

S:10.375 in

T:10.875 in

Week 24 Total vdH-S score (mean change from baseline at Week 24)1,3*†

SIMPONI® ARIA™ + MTX (n=395)

Placebo + MTX (n=197)

33%

12%

(P<0.001)

25%

59% (P<0.001)

63%

32%

(P<0.001)

97% inhibition vs control group‡

0.03 (P<0.001)

1.09

* vdH-S=van der Heijde Modified Sharp score. The total modified vdH-S score (0-448) is a composite score of structural damage that measures the number and size of joint erosions and the degree of joint space narrowing in the hands and feet. †

Missing data (linear extrapolation) rules were applied. For patients who early escaped, linear extrapolation was performed on the Week 16 data to the Week 24 endpoint.

‡

Percentage is the difference in mean total vdH-S scores divided by the placebo + MTX value.

GO-FURTHER™ was a global, multicenter, randomized, double-blind, placebo-controlled study in 592 adult patients who had moderately to severely active RA despite a stable dose of MTX (15-25 mg/week) for ≥3 months and who had not been previously treated with an anti-TNF agent. Moderately to severely active RA was defined as ≥6 swollen joints (out of 66 total) and ≥6 tender joints (out of 68 total), RF-positive and/or anti-CCP antibody– positive, and CRP ≥1.0 mg/dL. Patients were randomized to receive SIMPONI® ARIA™ 2 mg/kg + MTX (n=395) or placebo + MTX (n=197) as a 30-minute IV infusion at Weeks 0 and 4, and then q8 weeks through Week 100. At Week 16, patients in the placebo + MTX group with <10% improvement from baseline in both swollen joint count and tender joint count began receiving SIMPONI® ARIA™ 2 mg/kg beginning with an induction regimen at Weeks 16 and 20, followed by maintenance infusions q8 weeks in a blinded manner. At Week 24, all patients remaining in the placebo + MTX group began receiving SIMPONI® ARIA™ 2 mg/kg beginning with an induction regimen at Weeks 24 and 28, followed by maintenance infusions q8 weeks in a blinded manner. All patients continued to receive MTX. The primary endpoint was the percentage of patients achieving an ACR20 response at Week 14.

NEW

Learn more: www.SimponiAria.com/hcp

Re-envision infusion

Important Safety Information SERIOUS INFECTIONS Patients treated with SIMPONI® ARIA™ (golimumab) are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue SIMPONI® ARIA™ if a patient develops a serious infection.

Reported infections with TNF blockers, of which SIMPONI® ARIA™ is a member, include: • Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before SIMPONI® ARIA™ use and during therapy. Initiate treatment for latent infection prior to SIMPONI® ARIA™ use.

• Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.

• Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

Consider the risks and benefits of treatment with SIMPONI® ARIA™ prior to initiating therapy in patients with chronic or recurrent infection. Do not start SIMPONI® ARIA™ in patients with clinically important active infections, including localized infections. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with SIMPONI® ARIA™, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

Risk of infection may be higher in patients greater than 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressant therapy. Other serious infections observed in patients treated with SIMPONI® ARIA™ included sepsis, pneumonia, cellulitis, and abscess.

MALIGNANCIES Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which SIMPONI® ARIA™ is a member. Approximately half the cases were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma. The other cases represented a variety of malignancies, including rare malignancies usually associated with immunosuppression and malignancies not usually observed in children or adolescents. Malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants.

In the controlled portions of clinical trials of TNF blockers including the subcutaneous formulation of golimumab, more cases of lymphoma have been observed among patients receiving anti-TNF treatment compared with patients in the control groups. In clinical trials, the incidence of malignancies other than lymphoma and non-melanoma skin cancer per 100 patient-years of follow-up was 0.56 (95% CI: 0.01, 3.11) in the SIMPONI® ARIA™ group compared with an incidence of 0 (95% CI: 0.00, 3.79) in the placebo group. Cases of acute and chronic leukemia have been reported with postmarketing TNF-blocker use. The risks and benefits of TNF-blocker therapy should be considered prior to initiating therapy in patients with a known malignancy or who develop a malignancy.

Melanoma has been reported in patients treated with TNF-blocking agents, including the subcutaneous formulation of golimumab. Merkel cell carcinoma has been reported in patients treated with TNF-blocking agents. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.

HEPATITIS B REACTIVATION The use of TNF blockers, of which SIMPONI® ARIA™ is a member, has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic hepatitis B carriers. In some instances, HBV reactivation occurring in conjunction with TNF-blocker therapy has been fatal. The majority of these reports have occurred in patients who received concomitant immunosuppressants.

All patients should be tested for HBV infection before initiating TNF-blocker therapy. For patients who test positive for hepatitis B surface antigen, consult a physician with expertise in the treatment of hepatitis B before initiating

TNF-blocker therapy. Exercise caution when prescribing SIMPONI® ARIA™ for patients identified as carriers of HBV and closely monitor for active HBV infection during and following termination of therapy with SIMPONI® ARIA™. Discontinue SIMPONI® ARIA™ in patients who develop HBV reactivation, and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of SIMPONI® ARIA™, and monitor patients closely.

HEART FAILURE Cases of worsening congestive heart failure (CHF) and new-onset CHF have been reported. Exercise caution in CHF patients receiving SIMPONI® ARIA™ and monitor them closely during therapy. Discontinue SIMPONI® ARIA™ if new or worsening symptoms of heart failure appear.

DEMYELINATING DISORDERS Use of TNF blockers, of which SIMPONI® ARIA™ is a member, has been associated with rare cases of new-onset or exacerbation of demyelinating disorders, including multiple sclerosis (MS) and Guillain-Barré syndrome. Cases of central demyelination, MS, optic neuritis, and peripheral demyelinating polyneuropathy have rarely been reported in patients treated with the subcutaneous formulation of golimumab. Exercise caution in considering the use of SIMPONI® ARIA™ in patients with these disorders. Consider discontinuation if these disorders develop.

HEMATOLOGIC CYTOPENIAS There have been reports of pancytopenia, leukopenia, neutropenia, and thrombocytopenia in patients receiving SIMPONI® ARIA™ in clinical trials. Additionally, aplastic anemia has been reported in patients receiving TNF blockers. Exercise caution when using SIMPONI® ARIA™ in patients who have or had significant cytopenias.

K25GL13006

USE WITH OTHER DRUGS The concomitant use of a TNF blocker and abatacept or anakinra was associated with a higher risk of serious infections, therefore the use of SIMPONI® ARIA™ in combination with these products is not recommended. Care should be taken when switching from one biologic to another since overlapping biological activity may further increase the risk of infection. A higher rate of serious infections has also been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. The concomitant use of SIMPONI® ARIA™ with biologics approved to treat RA is not recommended because of the possibility of an increased risk of infection.

VACCINATIONS People receiving SIMPONI® ARIA™ can receive vaccinations, except for live vaccines. Administration of live vaccines to infants exposed to SIMPONI® ARIA™ in utero is not recommended for 6 months following the mother’s last SIMPONI® ARIA™ infusion during pregnancy due to an increased risk of infection.

HYPERSENSITIVITY REACTIONS Serious systemic hypersensitivity reactions (including anaphylactic reaction) have been reported following administration of the subcutaneous formulation of golimumab, some occurring after the first dose. If an anaphylactic or other serious allergic reaction occurs, discontinue SIMPONI® ARIA™ immediately and institute appropriate therapy.

ADVERSE REACTIONS The most serious adverse reactions were serious infections and malignancies.

Upper respiratory tract infection was the most common adverse reaction reported in the Phase 3 trial through Week 24, occurring in 6.5% of patients treated with SIMPONI® ARIA™ as compared with 7.6% of patients in the control group. The rate of infusions associated with an infusion reaction was reported in 1.1% of SIMPONI® ARIA™ infusions compared with 0.2% of infusions in the control group.

Please see brief summary of Prescribing Information for SIMPONI® ARIA™ on following pages.

References: 1. SIMPONI® ARIA™ (golimumab) Prescribing Information. Janssen Biotech, Inc. 2. Weinblatt ME, Bingham CO III, Mendelsohn AM, et al. Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with responses as early as Week 2: results of the phase 3, randomised, multicentre, double-blind, placebo-controlled GO-FURTHER trial. Ann Rheum Dis. 2013;72:381-389. 3. Data on file. Janssen Biotech, Inc. © Janssen Biotech, Inc. 2013

07/13

K25GLP13100

Brief Summary of Prescribing Information for SIMPONI® ARIATM (golimumab) SIMPONI® ARIATM injection, for intravenous use See package insert for full Prescribing Information.

WARNING: SERIOUS INFECTIONS AND MALIGNANCY SERIOUS INFECTIONS Patients treated with SIMPONI ARIA are at increased risk for developing serious infections that may lead to hospitalization or death (see Warnings and Precautions). Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Discontinue SIMPONI ARIA if a patient develops a serious infection.

Reported infections with TNF-blockers, of which SIMPONI ARIA is a member, include: • Active tuberculosis, including reactivation of latent tuberculosis.

Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Test patients for latent tuberculosis before SIMPONI ARIA use and during therapy. Initiate treatment for latent tuberculosis prior to SIMPONI ARIA use.

• Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.

• Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

Consider the risks and benefits of treatment with SIMPONI ARIA prior to initiating therapy in patients with chronic or recurrent infection.

Monitor patients closely for the development of signs and symptoms of infection during and after treatment with SIMPONI ARIA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy (see Warnings and Precautions).

MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which SIMPONI ARIA is a member (see Warnings and Precautions).

INDICATIONS AND USAGE: Rheumatoid Arthritis SIMPONI ARIA, in combination with methotrexate, is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

CONTRAINDICATIONS: None. WARNINGS AND PRECAUTIONS: Serious Infections Patients treated with SIMPONI ARIA are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, or parasitic organisms including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis, and tuberculosis have been reported with TNF-blockers. Patients have frequently presented with disseminated rather than localized disease. The concomitant use of a TNF-blocker and abatacept or anakinra was associated with a higher risk of serious infections; therefore, the concomitant use of SIMPONI ARIA and these biologic products is not recommended (see Warnings and Precautions and Drug Interactions). Treatment with SIMPONI ARIA should not be initiated in patients with an active infection, including clinically important localized infections. Patients greater than 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants such as corticosteroids or methotrexate may be at greater risk of infection. Consider the risks and benefits of treatment prior to initiating SIMPONI ARIA in patients: • with chronic or recurrent infection; • who have been exposed to tuberculosis; • with a history of an opportunistic infection; • who have resided or traveled in areas of endemic tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis; or • with underlying conditions that may predispose them to infection. Monitoring Closely monitor patients for the development of signs and symptoms of infection during and after treatment with SIMPONI ARIA. Discontinue SIMPONI ARIA if a patient develops a serious infection, an opportunistic infection, or sepsis. For patients who develop a new infection during treatment with SIMPONI ARIA, perform a prompt and complete diagnostic workup appropriate for an immunocompromised patient and initiate appropriate antimicrobial therapy and closely monitor them. Tuberculosis Cases of reactivation of tuberculosis or new tuberculosis infections have been observed in patients receiving TNF-blockers, including patients who have previously received treatment for latent or active tuberculosis. Evaluate patients for tuberculosis

SIMPONI® ARIATM (golimumab) risk factors and test for latent infection prior to initiating SIMPONI ARIA and periodically during therapy. Treatment of latent tuberculosis infection prior to therapy with TNF-blockers has been shown to reduce the risk of tuberculosis reactivation during therapy. Prior to initiating SIMPONI ARIA, assess if treatment for latent tuberculosis is needed. An induration of 5 mm or greater is a positive tuberculin skin test, even for patients previously vaccinated with Bacille Calmette-Guerin (BCG). Consider anti-tuberculosis therapy prior to initiation of SIMPONI ARIA in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Consultation with a physician with expertise in the treatment of tuberculosis is recommended to aid in the decision whether initiating anti-tuberculosis therapy is appropriate for an individual patient. Monitor patients for the development of signs and symptoms of tuberculosis including patients who tested negative for latent tuberculosis infection prior to initiating therapy.

Consider tuberculosis in the differential diagnosis in patients who develop a new infection during SIMPONI ARIA treatment, especially in patients who have previously or recently traveled to countries with a high prevalence of tuberculosis, or who have had close contact with a person with active tuberculosis. Invasive Fungal Infections If patients develop a serious systemic illness and they reside or travel in regions where mycoses are endemic, consider invasive fungal infection in the differential diagnosis.

Consider appropriate empiric antifungal therapy and take into account both the risk for severe fungal infection and the risks of antifungal therapy while a diagnostic workup is being performed. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. To aid in the management of such patients, consider consultation with a physician with expertise in the diagnosis and treatment of invasive fungal infections. Hepatitis B Virus Reactivation The use of TNF-blockers, of which SIMPONI ARIA is a member, has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic hepatitis B carriers (i.e., surface antigen positive). In some instances, HBV reactivation occurring in conjunction with TNF-blocker therapy has been fatal. The majority of these reports have occurred in patients who received concomitant immunosuppressants. All patients should be tested for HBV infection before initiating TNF-blocker therapy. For patients who test positive for hepatitis B surface antigen, consultation with a physician with expertise in the treatment of hepatitis B is recommended before initiating TNF-blocker therapy. The risks and benefits of treatment should be considered prior to prescribing TNF-blockers, including SIMPONI ARIA, to patients who are carriers of HBV. Adequate data are not available on whether anti-viral therapy can reduce the risk of HBV reactivation in HBV carriers who are treated with TNF-blockers. Patients who are carriers of HBV and require treatment with TNF-blockers should be closely monitored for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy. In patients who develop HBV reactivation, TNF-blockers should be stopped and antiviral therapy with appropriate supportive treatment should be initiated. The safety of resuming TNF-blockers after HBV reactivation has been controlled is not known. Therefore, prescribers should exercise caution when considering resumption of TNF-blockers in this situation and monitor patients closely.

Malignancies Malignancies in Pediatric Patients Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy ≤ 18 years of age), of which SIMPONI ARIA is a member. Approximately half the cases were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression, and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months (range 1 to 84 months) after the first dose of TNF blocker therapy. Most of the patients were receiving concomitant immunosuppressants. These cases were reported post-marketing and are derived from a variety of sources, including registries and spontaneous postmarketing reports. Use of SIMPONI ARIA in patients under 18 years of age has not been established. Malignancies in Adult Patients The risks and benefits of TNF-blocker treatment including SIMPONI ARIA should be considered prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing a TNF-blocker in patients who develop a malignancy. In the controlled portions of clinical trials of TNF-blockers including the subcutaneous formulation of golimumab more cases of lymphoma have been observed among patients receiving anti-TNF treatment compared with patients in the control groups. Patients with RA and other chronic inflammatory diseases, particularly patients with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk (up to several fold) than the general population for the

SIMPONI® ARIATM (golimumab)

SIMPONI® ARIATM (golimumab)

development of lymphoma, even in the absence of TNF-blocking therapy.

Cases of acute and chronic leukemia have been reported with postmarketing TNF-blocker use in rheumatoid arthritis and other indications.

Even in the absence of TNF blocker therapy, patients with rheumatoid arthritis may be at a higher risk (approximately 2-fold) than the general population for the development of leukemia. Melanoma has been reported in patients treated with TNF-blocking agents, including the subcutaneous formulation of golimumab. Merkel cell carcinoma has been reported in patients treated with TNF-blocking agents. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. In controlled trials of other TNF-blockers in patients at higher risk for malignancies (e.g., patients with COPD, patients with Wegener’s granulomatosis treated with concomitant cyclophosphamide) a greater portion of malignancies occurred in the TNF-blocker group compared to the controlled group. In an exploratory clinical trial evaluating the use of the subcutaneous formulation of golimumab in patients with severe persistent asthma, more patients treated with golimumab reported malignancies compared with control patients. The significance of this finding is unknown.

During the controlled portion of the Phase 3 trial in RA for SIMPONI ARIA, the incidence of malignancies other than lymphoma and NMSC per 100-patient-years of follow-up was 0.56 (95% CI: 0.01, 3.11) in the SIMPONI ARIA group compared with an incidence of 0 (95% CI: 0.00, 3.79) in the placebo group. Congestive Heart Failure Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNFblockers, including SIMPONI ARIA. In several exploratory trials of other TNF-blockers in the treatment of CHF, there were greater proportions of TNF-blocker treated patients who had CHF exacerbations requiring hospitalization or increased mortality. SIMPONI ARIA has not been studied in patients with a history of CHF and SIMPONI ARIA should be used with caution in patients with CHF. If a decision is made to administer SIMPONI ARIA to RA patients with CHF, these patients should be closely monitored during therapy, and SIMPONI ARIA should be discontinued if new or worsening symptoms of CHF appear. Demyelinating Disorders Use of TNF-blockers, of which SIMPONI ARIA is a member, has been associated with rare cases of new onset or exacerbation of central nervous system (CNS) demyelinating disorders, including multiple sclerosis (MS) and peripheral demyelinating disorders, including Guillain-Barré syndrome.

Cases of central demyelination, MS, optic neuritis, and peripheral demyelinating polyneuropathy have rarely been reported in patients treated with the subcutaneous formulation of golimumab. Prescribers should exercise caution in considering the use of TNF-blockers, including SIMPONI ARIA, in patients with central or peripheral nervous system demyelinating disorders. Discontinuation of SIMPONI ARIA should be considered if these disorders develop. Use with Abatacept In controlled trials, the concurrent administration of another TNF-blocker and abatacept was associated with a greater proportion of serious infections than the use of a TNF-blocker alone; and the combination therapy, compared to the use of a TNF-blocker alone, has not demonstrated improved clinical benefit in the treatment of RA. Therefore, the combination of TNF-blockers including SIMPONI ARIA and abatacept is not recommended (see Drug Interactions).

Use with Anakinra Concurrent administration of anakinra (an interleukin-1 antagonist) and another TNF-blocker, was associated with a greater portion of serious infections and neutropenia and no additional benefits compared with the TNF-blocker alone. Therefore, the combination of anakinra with TNF-blockers, including SIMPONI ARIA, is not recommended (see Drug Interactions). Switching Between Biological Disease Modifying Antirheumatic Drugs (DMARDs) Care should be taken when switching from one biologic product to another biologic product since overlapping biological activity may further increase the risk of infection. Hematologic Cytopenias There have been post-marketing reports of pancytopenia, leukopenia, neutropenia, aplastic anemia, and thrombocytopenia in patients receiving TNF-blockers. In clinical studies, cases of pancytopenia, leukopenia, neutropenia, and thrombocytopenia have also occurred in SIMPONI ARIA-treated patients. Caution should be exercised when using TNF-blockers, including SIMPONI ARIA, in patients who have or have had significant cytopenias. Vaccinations Patients treated with SIMPONI ARIA may receive vaccinations, except for live vaccines. No data are available on the response to live vaccination or the risk of infection, or transmission of infection after the administration of live vaccines to patients receiving SIMPONI ARIA. Hypersensitivity Reactions In post-marketing experience, serious systemic hypersensitivity reactions (including anaphylactic reaction) have been reported following administration of the subcutaneous formulation of golimumab. Some of these reactions occurred after the first administration of golimumab. If an anaphylactic or other serious allergic reaction occurs, administration of SIMPONI ARIA should be discontinued immediately and appropriate therapy instituted. ADVERSE REACTIONS: The most serious adverse reactions were: • Serious Infections (see Warnings and Precautions) • Malignancies (see Warnings and Precautions)

Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety data described below are based on one, randomized, double-blind, controlled Phase 3 trial in patients with RA receiving SIMPONI ARIA by intravenous infusion (Trial 1). The protocol included provisions for patients taking placebo to receive treatment with SIMPONI ARIA at Week 16 or Week 24 either by patient response (based on uncontrolled disease activity) or by design, so that adverse events cannot always be unambiguously attributed to a given treatment. Comparisons between placebo and SIMPONI ARIA were based on the first 24 weeks of exposure. Trial 1 included 197 control-treated patients and 463 SIMPONI ARIA-treated patients (which includes control-treated patients who switched to SIMPONI ARIA at Week 16). The proportion of patients who discontinued treatment due to adverse reactions in the controlled phase of Trial 1 through Week 24 was 3.5% for SIMPONI ARIA-treated patients and 0.5% for placebo-treated patients. Upper respiratory tract infection was the most common adverse reaction reported in the trial through Week 24 occurring in 6.5% of SIMPONI ARIA-treated patients as compared with 7.6% of controltreated patients, respectively. Infections Serious infections observed in SIMPONI ARIA-treated patients included sepsis, pneumonia, cellulitis, abscess, opportunistic infections, tuberculosis (TB), and invasive fungal infections. Cases of TB included pulmonary and extrapulmonary TB. The majority of the TB cases occurred in countries with a high incidence rate of TB (see Warnings and Precautions). In the controlled phase of Trial 1 through Week 24, infections were observed in 27% of SIMPONI ARIAtreated patients compared with 24% of control-treated patients, and serious infections were observed in 0.9% of SIMPONI ARIA-treated patients and 0.0% of control-treated patients. Through Week 24, the incidence of serious infections per 100 patient-years of follow-up was 2.2 (95% CI 0.61, 5.71) for the SIMPONI ARIA group, and 0 (0.00, 3.79) for the placebo group. In the controlled and uncontrolled portions of Trial 1, 958 total patient-years of follow-up with a median follow-up of approximately 92 weeks, the incidence per 100 patient-years of all serious infections was 4.07 (CI: 2.90, 5.57) in patients receiving SIMPONI ARIA (see Warnings and Precautions). In the controlled and uncontrolled portions of Trial 1, in SIMPONI ARIA treated patients, the incidence of active TB per 100 patient-years was 0.31 (95% CI: 0.06; 0.92) and the incidence of other opportunistic infections per 100 patient-years was 0.42 (95% CI: 0.11, 1.07). Malignancies One case of malignancy other than lymphoma and NMSC with SIMPONI ARIA was reported through Week 24 during the controlled phase of Trial 1. In the controlled and uncontrolled portions through approximately 92 weeks, the incidence of malignancies per 100 patient years, other than lymphoma and NMSC, in SIMPONI ARIA-treated patients was 0.31 (CI: 0.06, 0.92) and the incidence of NMSC was 0.1 (95% CI: 0.00, 0.58). Liver Enzyme Elevations There have been reports of severe hepatic reactions including acute liver failure in patients receiving TNF-blockers. In the controlled phase of Trial 1, through Week 24, ALT elevations ≥ 5 x ULN occurred in 0.6% of SIMPONI ARIA-treated patients and 0% of control-treated patients and ALT elevations ≥ 3 x ULN occurred in 2.4% of SIMPONI ARIA-treated patients and 2.5% of control-treated patients. Since many of the patients in the Phase 3 trial were also taking medications that cause liver enzyme elevations (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs], methotrexate [MTX], or isoniazid prophylaxis), the relationship between SIMPONI ARIA and liver enzyme elevation is not clear. Autoimmune Disorders and Autoantibodies The use of TNF-blockers, of which SIMPONI ARIA is a member, has been associated with the formation of autoantibodies and, rarely, with the development of a lupus-like syndrome.

At Week 20 in Trial 1, 17% of SIMPONI ARIA-treated patients and 13% of control patients were newly ANA-positive (at titers of 1:160 or greater). Of these patients, one SIMPONI ARIA-treated patient and no control-treated patients had newly positive anti-dsDNA antibodies. Administration Reactions In the controlled phase of Trial 1 through Week 24, 1.1% of SIMPONI ARIA infusions were associated with an infusion reaction compared with 0.2% of infusions in the control group. The most common infusion reaction in SIMPONI ARIA treated patients was rash. No serious infusion reactions were reported. Immunogenicity Antibodies to SIMPONI ARIA were detected in 13 (3%) golimumab-treated patients following IV administration of SIMPONI ARIA in combination with MTX through Week 24 of Trial 1. All patients who were positive for antibodies to golimumab had neutralizing antibodies based on an in vitro cell-based assay. The small number of patients positive for antibodies to SIMPONI ARIA limits the ability to draw definitive conclusions regarding the relationship between antibodies to golimumab and clinical efficacy or safety measures. The data above reflect the percentage of patients whose test results were considered positive for antibodies to SIMPONI ARIA in an ELISA assay. The ELISA assay is subject to interference by co-present

SIMPONI® ARIATM (golimumab)

SIMPONI® ARIATM (golimumab)

golimumab and thus the results are an underestimate of the rate of product immunogenicity and are in addition highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to SIMPONI ARIA with the incidence of antibodies to other products may be misleading. Other Adverse Reactions The adverse drug reactions that occurred at a rate of at least 1% in the SIMPONI ARIA + MTX group and with a higher incidence than in the placebo + MTX group during the controlled period of Trial 1 through Week 24 are summarized below. The numbers (percentages) of adverse drug reactions for SIMPONI ARIA + MTX-treated patients (n=463) and Placebo + MTX treated patients (n=197), respectively, were: Infections and Infestations: Upper respiratory tract infection (such as upper respiratory tract infection, nasopharyngitis, pharyngitis, laryngitis, and rhinitis) 13%, 12%; Viral infections (such as influenza and herpes) 4%, 3%; Bacterial infections 1%, 0%; Bronchitis 3%, 1%; Vascular disorders: Hypertension 3%, 2%; Skin and subcutaneous disorders: Rash 3%, 1%; General disorders and administration site conditions: Pyrexia 2%, 1%; Blood and lymphatic disorders: Leukopenia 1%, 0% Other and less common clinical trial adverse drug reactions Adverse drug reactions that occurred <1% in SIMPONI ARIA-treated patients during Trial 1 through Week 24 that do not appear in the Warnings and Precautions section included the following events listed by system organ class: Infections and Infestations: Superficial fungal infection, sinusitis, abscess, lower respiratory tract infection (pneumonia), pyelonephritis Investigations: Alanine aminotransferase increased, aspartate aminotransferase increased, neutrophil count decreased Nervous system disorders: Dizziness, paresthesia Gastrointestinal disorders: Constipation Post-marketing Experience There is no postmarketing experience available for SIMPONI ARIA. The following adverse reactions have been identified during post-approval use of the subcutaneous formulation of golimumab. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to golimumab exposure. Neoplasm Benign and Malignant: Melanoma (see Warnings and Precautions) Immune System Disorders: Serious systemic hypersensitivity reactions (including anaphylactic reaction) (see Warnings and Precautions), sarcoidosis Skin and subcutaneous tissue disorders: Skin exfoliation DRUG INTERACTIONS: Methotrexate SIMPONI ARIA should be used with methotrexate (MTX) (see Clinical Studies). Following IV administration, concomitant administration of methotrexate decreases the clearance of SIMPONI ARIA by approximately 9% based on population PK analysis. In addition, concomitant administration of methotrexate decreases the SIMPONI ARIA clearance by reducing the development of anti-golimumab antibodies. Biologic Products for RA An increased risk of serious infections has been seen in clinical RA studies of other TNF-blockers used in combination with anakinra or abatacept, with no added benefit; therefore, use of SIMPONI ARIA with other biologic products, including abatacept or anakinra is not recommended (see Warnings and Precautions). A higher rate of serious infections has also been observed in RA patients treated with rituximab who received subsequent treatment with a TNF-blocker. The concomitant use of SIMPONI ARIA with biologics approved to treat RA is not recommended because of the possibility of an increased risk of infection. Live Vaccines Live vaccines should not be given concurrently with SIMPONI ARIA (see Warnings and Precautions). Infants born to women treated with SIMPONI ARIA during their pregnancy may be at increased risk of infection for up to 6 months. Administration of live vaccines to infants exposed to SIMPONI ARIA in utero is not recommended for 6 months following the mother’s last SIMPONI ARIA infusion during pregnancy (see Use in Specific Populations). Cytochrome P450 Substrates The formation of CYP450 enzymes may be suppressed by increased levels of cytokines (e.g., TNFα) during chronic inflammation. Therefore, it is expected that for a molecule that antagonizes cytokine activity, such as golimumab, the formation of CYP450 enzymes could be normalized. Upon initiation or discontinuation of SIMPONI ARIA in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed. USE IN SPECIFIC POPULATIONS: Pregnancy Pregnancy Category B – There are no adequate and well-controlled studies of SIMPONI ARIA in pregnant women.

Because animal reproduction and developmental studies are not always predictive of human response, it is not known whether SIMPONI ARIA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. SIMPONI ARIA should be used during pregnancy only

if clearly needed. An embryofetal developmental toxicology study was performed in which pregnant cynomolgus monkeys were treated subcutaneously with golimumab during the first trimester with doses up to 50 mg/kg twice weekly (200 times greater than the maximum recommended human dose-MHRD) and has revealed no evidence of harm to maternal animals or fetuses. Umbilical cord blood samples collected at the end of the second trimester showed that fetuses were exposed to golimumab during gestation. In this study, in utero exposure to golimumab produced no developmental defects to the fetus. A pre- and post-natal developmental study was performed in which pregnant cynomolgus monkeys were treated with golimumab during the second and third trimesters, and during lactation at doses up to 50 mg/kg twice weekly (33 times and 12 times greater than the maximal steady state human blood levels for maternal animals and neonates, respectively) and has revealed no evidence of harm to maternal animals or neonates. Golimumab was present in the neonatal serum from the time of birth and for up to six months postpartum. Exposure to golimumab during gestation and during the postnatal period caused no developmental defects in the infants. IgG antibodies are known to cross the placenta during pregnancy and have been detected in the serum of infants born to patients treated with these antibodies. Since SIMPONI ARIA is an IgG antibody, infants born to women treated with SIMPONI ARIA during their pregnancy may be at increased risk of infection for up to 6 months. Administration of live vaccines to infants exposed to SIMPONI ARIA in utero is not recommended for 6 months following the mother’s last SIMPONI ARIA infusion during pregnancy (see Warnings and Precautions). Nursing Mothers It is not known whether SIMPONI ARIA is excreted in human milk or absorbed systemically after ingestion. Because many drugs and immunoglobulins are excreted in human milk, and because of the potential for adverse reactions in nursing infants from SIMPONI ARIA, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. In the pre- and post-natal development study in cynomolgus monkeys in which golimumab was administered subcutaneously during pregnancy and lactation, golimumab was detected in the breast milk at concentrations that were approximately 400-fold lower than the maternal serum concentrations.

Pediatric Use Safety and effectiveness of SIMPONI ARIA in pediatric patients less than 18 years of age have not been established. Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with other TNF-blocking agents (see Warnings and Precautions). Geriatric Use In Trial 1 in RA, the number of patients ages 65 or older was too small to make comparisons with younger SIMPONI ARIA-treated patients. Because there is a higher incidence of infections in the geriatric population in general, caution should be used in treating geriatric patients with SIMPONI ARIA. OVERDOSAGE: In a clinical study, 5 patients received single infusions of up to 1000 mg of SIMPONI ARIA without serious adverse reactions or other significant reactions. PATIENT COUNSELING INFORMATION: See FDA-approved patient labeling (Medication Guide) Advise patients of the potential benefits and risks of SIMPONI ARIA. Instruct patients to read the Medication Guide before starting SIMPONI ARIA therapy and to read it each time the prescription is renewed. Infections Inform patients that SIMPONI ARIA may lower the ability of their immune system to fight infections. Instruct the patient of the importance of contacting their doctor if they develop any symptoms of infection, including tuberculosis, invasive fungal infections, and hepatitis B reactivation. Malignancies Patients should be counseled about the risk of lymphoma and other malignancies while receiving SIMPONI ARIA. Other Medical Conditions Advise patients to report any signs of new or worsening medical conditions such as congestive heart failure, demyelinating disorders, autoimmune diseases, liver disease, cytopenias, or psoriasis. © Janssen Biotech, Inc. 2013 Horsham, PA 19044 1-800-JANSSEN (1-800-526-7736) US License No. 1864 at Cilag AG, Schaffhausen, Switzerland Revised: 09/2013 003883-131003

NORM Meeting Proceedings

Building Organizational Culture in a Rheumatology Practice Presented by Paul H. Caldron, DO, FACP, FACR, MBA Rheumatologist, Phoenix, AZ

Long Beach, CA—What is orga­ nizational culture? How is it dis­ tinguished from individual culture?

Is it important? Does it affect your bottom line? How does it apply to a rheumatology practice? Dr Paul H. Caldron addressed these questions during a breakout ses­ sion at the National Organization of Rheumatology Man­ agers 8th Annual Conference.

When teaching rheumatology fel­ lows, Dr Caldron encourages them to conceptualize rheumatology as an industry. “We talk about the characteristics of a service business, where attitude meets operations.

Service offerings are intangibles; they are deeds, actions, experiences, and perishables. They are nonstor­ able, momentary, and spontaneous.

Your encounter [with patients] is the product. One must be mindful that often, to the patient, you are only as good as your last encounter.”

Patients risk having a hetero­ geneous experience in your office, he noted, while the experience should be consistent and relatively seamless as they go through dif­ ferent departments in a practice.

Success in a service business cen­ ters on an operational process. “It is not rocket science; on the other hand, it requires stable people who can be groomed for consistency at their position and throughout the organization.”

Dr Caldron used the tradition­ al services marketing triangle to discuss management of the inter­ nal environment. At the top of the pyramid is the company. At 1 angle at the bottom is the customer (the patient) and at the other, the staff member (who is your internal

customer). The company sets the promise (the expectation) of what it will do and what it will not do: “We will provide you top-notch rheumatologic care, but we will not be your generalist or manage your hypertension or diabetes, nor will we fill prescriptions in the middle of the night.”

“Your encounter [with patients] is the product. One must be mindful that often, to the patient, you are only as good as your last encounter.”

—Paul Caldron, DO, FACP, FACR, MBA

The company enables the prom­ ise, making sure the staff members understand what the promise is and how it is to be delivered (internal marketing). The staff is then ready to help deliver on the promise to the customer. “This all begins,” Dr Caldron explained, “with orienta­ tion, training, cross-training and reinforcement—all the things that will develop the internal custom­ er who will help you deliver the promise.”

Company Culture Applies to Rheumatology Practice Individual culture, he noted, stems from the totality of a per­ son’s individual experiences layered

on family, communi­ ty, race, nationality, religion, gender, and education. While one must respect each person’s broader cul­ tural background, Dr Caldron noted that office staff must remember that the foreground of the individual’s culture rests on his or her own personal experiences and choices.

Organizational culture—although distinct from leadership, manage­ ment approaches, strategies, and pol­ icies—involves all of these. Building a culture requires a shared mind-set, a basic pattern of assumptions that constitute shared values and beliefs.

Organizational culture is developed by a group as it learns to cope with the problems of adaptation and internal integration. These patterns work well enough to be passed on to new members of the group.

Dr Caldron discussed the Dis­ neyland operational culture as a commonly cited example. There, staff members in the public eye, even custodians, may be costumed as characters, minor or well rec­ ognized. In the back office, all are valued equally. Each has his or her job and everyone is called a “cast member,” rather than an employee.

In some companies, organizational culture modifies and defines the bottom line and enables companies to deal with change. Herb Kelleher, the founding CEO of Southwest Airlines, noted that, “It’s the intan­ gibles that are the hardest things for a competitor to imitate. You can get an airplane. You can get counter space; you can get baggage convey­ Continued on page 26

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Affordable Care Act

Building Organizational Culture in…Continued from page 25 ors. But it is our esprit de corps—the culture, the spirit—that is truly our most valuable competitive asset.”

The Whats and the Hows The key components of building an organizational culture are the whats and the hows. Whats address the shared mind-set. Are the lead­ ership and the functional staff on the same page regarding the mission and goals of the company? Do they all understand the market? What are the attitudes in these positions?

When you attempt to merge groups, it is an occasion when differences in cultures become stark.

The how part has to do with cul­ tural forms and perceptions of com­ pany practices, such as jargon (the shorthand in communications), sto­ ries (from the history of the orga­ nization and events that describe your culture), rituals (anything from prayer meetings before you start the workday to going out for happy hour after work), and humor.

Perceptions of company practic­ es begin during the staff selection process. Staff should be oriented to your cultural norms and have some degree of cross-training. Staff should fully understand the rewards system. Principals should remain aware that resource allocation speaks volumes to the staff about values. It strengthens the percep­ tion of a shared mind-set when staff members understand how company actions benefit the organization and the patients.

Cultures Vary There is no cookbook to building an organizational culture because it arises from both leadership and staff, both current strategy and his­ tory, and from a variety of both internal and external pressures.

Consequently, it takes a long time to develop. Culture is fashioned by

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nurturing the positive components and disassembling the negative ones. As an example, Dr Caldron described how research patients in his practice at one time were treat­ ed as second-class citizens. They were seen by nonresearch staff as nonpaying patients despite the fact that a great deal of revenue is gener­ ated through clinical investigation.

Research subjects were undervalued

“There is no room for prima donnas....We have 2 overarching requirements for employment: you have to be competent and you have to get along.”

—Paul Caldron, DO, FACP, FACR, MBA

and made to wait until the doctor was caught up. In examining the paradox, it was determined that part of the dynamic was that they were not put on the schedule for the clinician, lab, infusion, imag­ ing, and other services. Remedies included locking research activi­ ties into everyone’s schedule and incorporating a series of initiatives and incentives to elevate the status of research subjects. Now research activities are interwoven into the fabric of daily activities. Cultural jargon now also includes “the blue coats” as the affectionate moniker for the research coordinators.

Case Study Dr Caldron provided a case study

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to illustrate differences in company culture and how they affect outcomes.

“Rheumacare” had a high staff turnover rate (50%), which was considered “acceptable.” There were 4 rheumatologists and 3 offic­ es at which they offered multiple services. Staff had limited train­ ing and orientation and they were micromanaged, mostly by an out­ spoken manager. Analysis revealed frequent rearranging of work prior­ ities and no delegation of author­ ity. There was no health plan or retirement plan. The result was a low sense of job security and low morale. The practice manager took her cues from a singular physician and disregarded input from other partners and staff.

Dr Caldron guided an analysis of the cultural dysfunction that existed and its stepwise reconstruction. As 1 measure of outcome, ultimately, the turnover rate dropped to 8%.

New processes involved standard­ ized training and orientation, devel­ opment of an employee manual, institution of a group health policy and 401K, information intranet, and biannual all-staff meetings. A civil­ ity policy was instituted among all stakeholders and enforced. Patient and staff satisfaction was surveyed on a scheduled basis and intensely analyzed and acted upon.

To support one’s practice cul­ ture, Dr Caldron urged focusing on patients and the staff community.

“There is no room for prima donnas.

There should be a clear chain of command and a civility policy, and ground rules for group and person­ al safety. We have 2 overarching requirements for employment: you have to be competent and you have to get along. You can’t have one and not the other or, in our culture, you stand out like a sore thumb. When this does occur, staff expects us to act on it and we do.” l

NORM Meeting Proceedings

Social Media and Online Reviews—How to Take Control of Your Reputation without Trying to Be Everywhere at Once Presented by David Griner Founder and President, Ishmael Digital Content

Long Beach, CA—There is now a big push to meld online reviews into search engines and social media, and this transition is poised to occur within the next few months, giving rheumatology practice managers the opportunity to take advantage of the shift. Practice managers may feel like they are falling behind and that it is tough to keep up with online reviews, let alone find the resources to keep up with them.

At the National Organization of Rheumatology Managers 8th Annual Conference, David Griner explained that online reviews matter more now than they did just a year ago. He noted many review websites are still largely third-party sites. TripAdvisor provides reviews for hotels.

Yelp provides reviews for restaurants and others. Angie’s List, Yahoo, Healthgrades, Vitals, RateMDs, and others have provided medical reviews; however, the future of niche review sites has become uncertain, mainly because the people who con­ trol the search results (predominate­ ly Google, but also Yahoo, Microsoft Bing, and even Facebook) want to own this piece of the review pie.

Quite a bit of money is pumped into ensuring that certain review sites come out on top when you do a search. Google, however, has decid­ ed that they don’t want other review sites, or even your own review site, to come up first in a web search.

They want their own review site to come up first, while other search engines are slowly pushed down.

Consequently, they are elevating their own review services. At the moment, there are not many reviews

in Google’s review service. As search engines and social networks begin to prioritize their own review tools and encourage more participation, rheu­ matology centers will have a huge opportunity because they will not have to focus on third-party review sites, but can prioritize their own search engines to meet the shift.

“We are in a new era of online reviews.

It’s time to get proactive and start thinking about how to encourage positive reviews and maintain your reputation for years to come.”

—David Griner

“We are in a new era of online reviews. It’s time to get proactive and start thinking about how to encour­ age positive reviews and maintain your reputation for years to come,” Mr Griner said. Providing reviews is the latest online craze. “It’s this level of immediacy that we are going to see. You just left this restaurant; will you review it? You just left this busi­ ness; will you review it?”

The key, he noted, is to be pro­ active. “Just start thinking about what you can do to encourage pos­ itive reviews.” When you encour­ age reviews, your online sales, prod­

uct scores, number of reviews, and site traffic all increase. “If you don’t ask for reviews or you don’t share that there are ways to review your practice and patients’ experiences, you will surely only get negative reviews. Patients don’t often go out of their way to give you a positive review. They might instead thank you on the way out. But if a patient has had a bad experience and they have no other recourse but to call the same front desk that gave them a problem in the first place, they are likely to go out of their way to write a negative review,” Mr Griner warned.

In most cases, negative experiences are the exception, but if those are the only ones recorded online, it will work against your practice.

Protecting Your Online Reputation How does a practice get involved?

How does a practice become more proactive about reviews? Using the Google search engine, Mr Griner gave a quick tour of how patients discover a practice online and what they might find along the way. As an example, he showed 1 review where—even though there were 30 other reviews—the top review was a negative one (1 star out of 5) that reported how a doctor refused to per­ form tests that the patient thought were pertinent to his health, and that the wait times were inordinately long. He then walked the audience through the various options they could encounter in trying to manage Continued on page 28

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NORM Meeting Proceedings

Social Media and Online Reviews…Continued from page 27 their practices’ online reputations.

At the bottom of the Google page, there is a setting for Feedback and a link asking, “Are you the busi­ ness owner?” You can click Feedback (if you don’t want to claim that you own the business) and respond to questions about the business and change settings. Feedback allows you to change business information eas­ ily. Google verifies changes to the business by phone or postcard when changes are made on the site.

Most business listings on Google are automatically generated on “Google Places.” These are gradually being merged into business pages on the social network Google+. When you set up and verify a Google+ page for your business, it also claims your Google Places business listing.

Google+, cautioned Mr Griner, is not a good Facebook competitor, if you are looking to become active in social media. Facebook has 1-billion users, whereas Google+ has only 150,000-million users.

What about Microsoft’s Bing?

For now, no medical practices have reviews on them. Bing is the world’s second-largest search engine with

Points to Consider • Make sure you know what comes up when you search for your business online.

• Take advantage of Google’s stream­ lined approach to business listings.

• Consider maintaining a Google+ account and a Facebook page.

• If you have the resources, keep an eye on Yelp, Angie’s List, Yahoo, and medical review sites.

• Encourage reviews among your pa­ tients to build an accurate and posi­ tive reputation online.

• When faced with negativity, take the high road, but show that you’re responsive.

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165-million users a month, compared with Google’s 1 billion and Yahoo’s 160 million. Most of Bing’s local busi­ ness reviews are generated via Yelp; however, medical facilities listed in “Bing Local” do not currently include reviews. For now, Mr Griner advised that Bing should not be a priority.

“Yahoo used to be a good place for reviews,” he noted, “but they are moving their business model else­ where.” Yahoo has a strong number of

“If you don’t ask for reviews or you don’t share that there are ways to review your practice and patients’ experiences, you will surely only get negative reviews.”

—David Griner reviews on its search results, but many are several years old. Consumers have largely moved on to other networks, particularly mobile apps.

Facebook is one of the largest websites in the world and should retain an important place for active businesses. It is easy to manage, it is yours to control, and it is limited to existing customers who use their real names, and are thus less likely to post false or damning things about your practice. If someone posts a bad comment, you can remove or hide it, because it is your page. Facebook is an easy way to direct existing and potential patients to your other dig­ ital resources, such as e-mail, news­ letter, or website testimonials.

Yelp (which is open to the public) and Angie’s List (which is limited to members only) remain popular

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How to Handle a Negative Review 1. Determine if the complaint is valid, and, if so, address it internally first.

2. Don’t rush to respond. You may need to ask an attorney for the best way to proceed from a legal standpoint.

3. Take the high road. Don’t let the review get to you. services and regularly receive new reviews. Mr Griner recommends mon­ itoring both and responding when necessary, if the resources are available to do so. Patients tend to consult both places for information on a medi­ cal practice. Both sites offer methods for response; however, removing false claims is nearly impossible.

“If you do respond to a review, avoid responding only to negative reviews,” Mr Griner warned. He recommended calling attention to the good reviews once in a while.

“If someone posts what you think is a patently false review, you might respond by saying you cannot find their file and ask them to come in for a discussion.”

Encouraging good reviews is a good way to build a positive and accu­ rate reflection of your business online.

Restaurants use placards or cards on the table to encourage reviews, most of which will be positive. Requests for reviews can be displayed using stick­ ers, posters, table tent cards, receipts, magnets, or buttons. Have patients review their experiences while they are still in the office. Happy patients like to reward good practices. Use dig­ ital resources (eg, Facebook, Google, e-mail, websites) to encourage reviews.

“Bear in mind that hotels and restau­ rants with the highest reviews are not necessarily the best ones, but those that encourage reviews.” l

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

NORM Meeting Proceedings

HIPAA Omnibus Compliance—You Can Succeed Presented by Karen Gregory, RN Director of Compliance and Education, Total Medical Compliance, Indian Trail, NC

Long Beach, CA— The final reg­u­la­tions to update the Health In­formation Por­ta­ bility and Accoun­ ­ tability Act (HIPAA) privacy rules outline the process for breach identification and notification, and pro­ vide further definition of “business associates.” The effective date was March 26, 2013. Karen Gregory, RN, reminded listeners at the National Organization of Rheumatology Managers 8th Annual Conference that September 23, 2013, was the compliance date for the new changes that were published for HIPAA this year. Was your practice ready? And just how safe are your documents?

There have been several recent inci­ dents in which medical records were seriously compromised: • On July 15, 2013, 4 desktop com­ puters were stolen from Advocate Med Group in Chicago, compro­ mising the medical records of 4 million patients.

• On July 22, 2013, a laptop was stolen from a St. Louis ortho­ dontist’s office that compromised the medical records of 10,000 patients.

• On August 2, 2013, a laptop was stolen from a physician’s prac­ tice at the University of Texas Health Science Center, compro­ mising the medical records of 600 patients.

To prevent a similar incident in your practice, Ms Gregory urged practices to prepare. “If you are not doing a risk analysis and updating it based on what’s going on in your practice, you do not know what the

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areas of vulnerability are as they relate to information stored elec­ tronically. If you do not know this, then you cannot protect yourself against an inappropriate action,” she said.

The security rule states exactly what is required—you must update and conduct a risk analysis in your practice to protect yourself and your

“If you are not doing a risk analysis and updating it based on what’s going on in your practice, you do not know what the areas of vulnerability are as they relate to information stored electronically.”

—Karen Gregory, RN

patients. Ms Gregory noted, “There is no wiggle room in there. And the security rule clearly states that you must perform a risk analysis. You must list what the issues are, and you must fix them.”

In stage 2 meaningful use, practic­ es must address the encryption and security of their data. This means that anything in your practice that stores data (eg, every desktop, lap­ top, tablet, or mobile phone) must be encrypted.

Notice of Privacy Practices Your office’s Notice of Privacy

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Practices (NPP) must be updated with regard to authorizations and patients’ rights. Authorizations must be obtained prior to the release of any protected patient information.

It is not necessary to provide the new notice to existing patients.

Redistribution is not necessary; however, the new notice must be given to all new patients either via e-mail, mail, or in person. Practices must be aware of the new patients’ rights: (1) If a patient does not want you to file an insurance claim and prefers to pay out of pocket, you must comply with the patient’s request. If the insurance company seeks to review certain files on your patients, you must note somewhere that this transaction was paid out of pocket and you are then obliged to keep it private and not show the insurance company; (2) You must inform patients of any breach­ es. The revised NPP must be dis­ played in a prominent location and patients must sign the acknowledg­ ment form. If your organization has a website, you must remember to update the NPP on the company website.

Business Associate Relationships A business associate (BA) is an entity that creates, receives, main­ tains, or transmits protected health information on behalf of a covered entity (ie, your practice). Your prac­ tice must obtain satisfactory assur­ ance in the form of a contract or other arrangement that the BA will safeguard the information appropri­ ately. The rule has been updated to include: • A health information organiza­

NORM Meeting Proceedings

tion, e-prescribing gateway, or other person that provides data transmission services with respect to protected health information to a covered entity, and that requires routine access to such protected health information.

• A person who offers a personal health record to 1 or more indi­ viduals on behalf of a covered entity.

A BA is also responsible to pro­ tect patient information. In fact, your BAs can have their own BAs (eg, a subcontractor, such as a shredding company). That subcon­ tractor will also be subject to the same liabilities and responsibilities.

“Your practice is not responsible for entering into a contract with a subcontractor; however, if the subcontractor has a problem, your practice is responsible for reporting it. Furthermore, if someone per­ forms a BA function, even without a contract in place, the rules still apply,” Ms Gregory warned.

A breach is the unauthorized acquisition, access, use or disclosure of public health information not permitted under the privacy rule that compromises the security or privacy of such information. “Before September 23, 2013, if there was no harm, there was no liability. But after September 23, even if no harm occurred, your practice might be liable.” All breach exclusions must be documented: • A worker with authority to access information accidentally accesses the wrong record.

• A worker with authority inadver­ tently shares information with another worker not involved in the care of the patient.

• A worker shares information with a person who is not authorized, but the unauthorized person to whom the disclosure was made would not reasonably have been able to retain such information.

Despite these exclusions, it is

important to decide which breach to report. Remember, once you con­ sider something a breach of pri­ vacy, you are bound to report it.

Document every event, even the exclusions, and why you think they are not breaches.

How BAs communicate breaches should be outlined in the contract, including how quickly breaches must be reported to you, because your organization ultimately has the responsibility to report the breach.

Note that laboratories do not need BA agreements, because they are covered entities.

“There is no wiggle room in there. And the security rule clearly states that you must perform a risk analysis.”

—Karen Gregory, RN The law requires written con­ tracts between practices and BAs, but existing agreements may stay in place until September 23, 2014.

Updated contracts must include required uses and disclosures. There must be a provision to comply with the security rule with respect to electronic patient health informa­ tion and the elements of the privacy rule that apply to the covered enti­ ty. Breach reporting requirements to the practice must also be clearly outlined.

Access to Protected Health Information Patients have a right to access their own information. They can ask for a copy of their records and you can charge a “reasonable costbased fee.” When you are releas­ ing information to the patient and

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to the patient only, you cannot include an administrative fee. The fee must be related to the number of pages you are releasing.

If you store information in an electronic format and the patient seeks a copy of his or her notes in an electronic format, your practice is required to provide a readable copy of the medical notes to the patient.

“You need to keep in mind what format you will provide this infor­ mation,” Ms Gregory noted. “If a patient requests that you send their medical records via e-mail to anoth­ er physician, you must do this as required by law. If you do not have the capacity to send the information in a protected manner (encrypted), you must inform the patient that you will comply with their request, but that the information will not be protected.” The important issue is to comply with all patient requests, while informing them of any risks that this action might entail.

Research authorizations can be combined with conditioned or unconditioned elements. Practices can have a research authorization that will allow you to use informa­ tion for future research studies.

For fundraising communications, a practice does not need a patient’s permission to send fundraising information; however, you must give patients the option to opt out and not receive further fundraising information or requests.

Fines for Willful Neglect Fines for willful neglect range from $100 to $50,000. Fines can begin at $50,000 and are capped at $1.5 million for violations of iden­ tical provisions in the same year.

Practices may be fined even if the practice was unaware of a violation that the US Department of Health & Human Services investigated.

The time is now to look at the updated regulations and make the required changes. l

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31

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NORM Meeting Proceedings

And Your Point Is? Presented by Meryl Rose, CSP Author and Founder, Speak STRONG, Inc

Long Beach, CA— Addressing the audi­ ence at the National Or­ga­­nization of Rheu­ matology Managers 8th Annual Conference, Meryl Rose, CSP, be­ gan her presentation on communication by re­ calling how she was driving home one day and noticed plumes of smoke on the way. It was a bad sign, as there were many fires near her Cascade, Colorado, home that summer. When she arrived home, she received a reverse 911 call: all homeowners were required to leave their homes immediately be­ cause of the imminent danger of fire.

As she and her husband prepared to leave the house, he recommended leaving the cat—he thought they’d be gone for only a few hours. Ms Rose recalls hearing a voice with­ in her that clearly said, “Take the cat.” “No,” she said strongly, “we’re taking the cat.” As it turned out, they were unable to return home for several days. The takeaway from this experience, she said, was “to be able to make a point when you need to make a point.”

She continued by asking, “How long does it take to answer a very simple yes or no question?”

Normally, seconds, unless, as Ms Rose observed, “you are a member of my family. If I ask my sister a question that requires a yes or no answer, it usually takes her about 5 minutes to answer.” Her brother has even more trouble staying on target.

Without intervention, it could take him 30 minutes to come up with an answer. Ms Rose described him as a master of tangents.

Unfortunately, she observed, the very things that irritate you where

34

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family is concerned are often the very things that fashion how you communicate with others. There is a great deal of power, she noted, in “being able to make a point so that listeners get the point. Why don’t we get to the point right away? Why don’t we say what we mean and mean what we say, without being mean when we say it?”

Learning How to Communicate—A Tough Life Lesson “One of the things that prevent us from communicating well is that we are afraid people will not like what we say or not want to hear what we say,” she observed. “If a doctor who is showing his patient an x-ray prefaces his remark with, “What I am going to show you will change

There is a great deal of power in “being able to make a point so that listeners get the point. Why don’t we get to the point right away?”

—Meryl Rose, CSP

your life forever,” are you then sure you really want to hear what he has to say after that?” It is not easy, she said, to tell people things they do not want to hear. The author of 10 books on communication, Ms Rose further pointed out that she was qualified to write these books because she came so far on her own journey in the quest to commu­

RHEUMATology Practice Management

I December 2013

Be Brief A power phrase is as long as it needs to be and no longer. Ms Rose recommends sorting things out in advance to help keep what matters front and center.

“Specifics and examples ground your point in reality.”

Tap into the power of welldefined points: • Guide your aspirations • Stay on course • Filter distractions • Focus on the topic/ conversation • Frame the discussion nicate clearly and kindly. As she explained, in the beginning there might have been the Word, but she confessed to not knowing how to use words to communicate at all.

In 1986, her husband became ill.

“No one could have been more in denial,” she observed. He had can­ cer, and any attempt to talk about it would make him completely shut down. Nine months later, Ms Rose lost her husband to the cancer, which had been left untreated. At first, she blamed him for shutting her down, but it dawned on her that it was not his hand over her mouth, but hers. This experience made her a woman on a mission. “The ultimate responsibility for making a point rests on your shoulders,” she said.

Sometimes organizations com­ pound the problem. Once, a friend of hers had to fire someone. The friend had a protocol to follow for firing this person, and she gave the person what she thought was a very straightforward message: “We thank you for your service, but….” The “but” was enough to make the mes­

NORM Meeting Proceedings

sage fuzzy, and the response was, “OK, I’ll think about it.” Something was not clear when the person did not get the point—that they were being fired, not simply reprimand­ ed. Apparently, the message got lost as it was translated through the company protocol. In other words, a weak point left room for misinterpretation.

“A person hears what they think you have said,” Ms Rose explained.

“Similarly, if you muddle through giving someone simple constructive criticism without intending to fire the person, he might overreact and pack his things. In this example, a person interprets a very straight­ forward comment in a catastrophic way.” For overly sensitive employ­ ees, she recommended that it might help to have a conversation about the conversation: “How can we dis­ cuss improving your work without having you become overly sensitive about my comments?”

Getting to the Point and Staying There Ms Rose reiterated her point: “A weak point leaves a lot of room for misinterpretation. A clear point cre­ ates context and focus. Give yourself focus. Know what you are going to say. Keep your point front and center so that everything you say is tied to that point. Don’t leave your cat behind because you can’t make a point.”

What, then, is a “point”? A point, she noted, is the most important essential element in a discussion. It is important, then, to know what really matters. In other words, do you know what really matters in a discussion without engaging in wandering generalities? Do you know the objective or purpose to be reached or achieved? Ms Rose urged listeners to identify the point they are trying to make and stay on point.

Doing so will keep the priorities perfectly clear.

Good communication is critical in any medical practice, and Ms Rose urged practice managers to use the many tools available to them to minimize communication weakness­ es and to get to the point. She noted that, “Even in PowerPoint you can organize your slides in sections.

Workflow tools are really about organizing your thoughts so that you can make your point(s) clearly throughout the workday. So all of the pieces required to run a practice don’t get muddled together, they must first be organized. Points take you first from the trees to the forest and then back again so that you can reorient yourself, while seeing where you are and while all of the details are taken care of. It makes sense to be able to attend to details while keeping your eye on the entire picture—that is, both the trees and the forest.”

“Be clear. Say what you mean and mean what you say, without being mean when you say it.”

—Meryl Rose, CSP Conversation as a Blank Slate There might be times when you don’t want to be specific about your point so that you can be open to the ideas of others. One pediatrician liked the idea of having dolls with no features, so that children could project onto the doll whatever affect they felt was appropriate. If the doll smiled all the time, it would not be possible for that doll to express the sadness or anger that a child might be feeling. A less-defined point would allow others to define it, “like throwing spaghetti against the wall

Sort Your Message— Bullets Clarify Your Point 1. Overview 2. Main point A. Subpoint B. Another subpoint a. Example b. Another example 3. Summary and call to action Sorting keeps front and center what matters. and waiting to see what sticks.” But Ms Rose cautioned against doing this unless you really know what you are doing.

Every conversation is a blank slate, and it’s important to know who is writing on your slate. “Find your point and share it, even if your point is to work together to reach a point.”

Ms Rose strongly recommended aim­ ing for the “sweet spot”—balancing mind, heart, and will—when making a point. Several times during her pre­ sentation, she reiterated her mantra: “Be clear. Say what you mean and mean what you say without being mean when you say it.”

Ms Rose recalled a time when she called her stepmother who was up at the family’s cabin by herself. Her stepmother said, “This might not be a good time to come. I am laid up and this will leave all the work for you to do.” The truth was that her stepmother needed help, but could not, or would not, ask for it directly.

Had Ms Rose taken her literally, she would not have gone up to the cabin to help, but would have missed seeing and helping her stepmother.

Many people, she observed, do not say what they mean—whether from cultural or learned habits—and you must learn to interpret their mean­ ing. In this case, her stepmother was being passive.

There are 4 ways of commu­ nicating—being passive, being Continued on page 36

December 2013

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www.RheumatologyPracticeManagement.com

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ACR Meeting Highlights

Examine How the Affordable Care Act Will Impact Your Practice

By Wayne Kuznar

San Diego, CA—Most elements of the Affordable Care Act (ACA) will be implemented by 2014. With it, providers should expect changes in patient demographics and payer mix, said Audrey E. Coaxum, CHI, CMCO, CMC, CMIS, CMOM, faculty/consultant at the Practice Management Institute in San Antonio, TX. Providers may want to think about a plan of action with respect to patient eligibility verification and payment contracts in anticipation of such changes, she said at a practice management course held prior to the 2013 meeting of the American College of Rheumatology.

Practices should be ready for any changes in patient profiles as the healthcare exchange programs under the ACA are rolled out.

Some patients who were previously

self-pay may now have insurance, others who were part of a pre­

“Offices will have to do their due diligence as it relates to eligibility verifications up front, before patients actually show up in the facility.”

—Audrey E. Coaxum, CHI, CMCO, CMC, CMIS, CMOM

ferred provider network may move to point-of-service plans or health maintenance organizations. Many

patients may have higher deduct­ ibles under their plans, and those patients may need to be considered similar to self-paying patients, said Ms Coaxum.

“Offices will have to do their due diligence as it relates to eligi­ bility verifications up front, before patients actually show up in the facility,” she said. “They may have to alert them about any changes in their benefits plans or even explain to them how to work through their benefits plans, because they may be dealing with patients that never had insurance before. The upfront education will potentially cause a change in their operations, especially with respect to the time doing education.”

Obtaining up-to-date patient demographic information is para­ mount to the collection process.

Continued on page 38

And Your Point…Continued from page 35 aggressive, being passive-aggres­ sive, and being assertive. Only 1 of these ways will prove to be effec­ tive. Being passive does not work: “I have no power anyhow, but…,” “I can’t be successful because….”

Being assertive can work, but it might not always produce the results you seek.

While being assertive, most peo­ ple fail to see the person they are communicating with as a partner.

“It is most important to establish what you want as the outcome of a conversation and focus solely on that,” she observed.

She recommended that to com­

36

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municate your point effectively in a discussion, use phrases that will best emphasize that point: • “Here’s the thing…”

• “One thing I want you to remem­ ber is…”

• “It’s important to consider that…”

• “Let’s focus on…”

• “We can sum this up by saying…”

• “All of this leads me to con­ clude…”

Likewise, use phrases to encourage others to get to their point: • “I’m confused. What is your main point?”

• “I’m missing your point.”

• “I’m getting lost in the details

RHEUMATology Practice Management

I December 2013

here. Can you summarize what you are trying to tell me?”

• “That’s not answering my ques­ tion. The point I am going for is…”

You should practice emphasizing your points in e-mails as well as in conversation: • Choose a strong subject line.

• Have a purpose statement.

• Prepare an overview.

• Have a distinct body section.

• Include a summary.

• Close with a call to action.

Ms Rose closed her presentation with an excellent point: “Life is too precious to be pointless.” l

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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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

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

ACR 2013 Highlights

Examine How the Affordable Care Act…Continued from page 36 “If practices have to do any collec­ tions on the back end, they have to make sure that the information they’re getting is current because the worst thing to have in collec­ tions is bad demographic informa­ tion,” she said.

Some services offered by the practice may have different levels of medical necessity as the coding system is switched to International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM). The ICD-10 cod­ ing system is much more specific than International Classification of Diseases, Ninth Revision.

“There may again be the potential for a refocus as far as benefits inter­ pretation,” said Ms Coaxum. “Again, it may be more patient financial responsibility versus a service that’s covered by the patient’s insurance.”

“The exchanges don’t go into effect until 2014, but clinics should be gearing up right now to get ready for next year. They need to start working toward creating a plan of action to get policies and procedures in place.”

Transitioning your practice to electronic health record (EHR) technology, if you have not already done so, is a must if you treat Medicare patients, said Ms Coaxum, as failure to demonstrate meaningful use of EHR will incur a penalty starting in 2015.

The 3 main components of meaningful use are: • The use of a certified EHR in a meaningful manner, such as elec­ tronic prescribing.

• The use of certified EHR tech­ nology for electronic exchange of health information to improve quality of healthcare.

• The use of certified EHR technol­ ogy to submit clinical quality and other measures.

38

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The American Recovery and Reinvestment Act of 2009 pro­ vided funding for practices to receive incentive payments totaling $44,000 per physician over 5 years to partially offset the cost of imple­ menting EHR technology. The last year to begin participation in the Medicare EHR Incentive Program is 2014, but the incentive payment is reduced to a maximum of $29,000 if participation was delayed until after 2012. The penalty starts at 1% and increases each year that a Medicare-eligible professional does not demonstrate meaningful use, to a maximum of 5%.

“Many times practice administrators don’t focus much on the financial viability of their practices, and we want to change that mindset.”

—Audrey E. Coaxum, CHI, CMCO, CMC, CMIS, CMOM

Getting on Board with Quality Reporting Insurers will start sharing basic information about providers with their customers, including whether or not the practice is participating in the Physician Quality Reporting System (PQRS). “The PQRS is designed to give the patient population all of the ammunition they need to select the best providers for them based on how providers deliver healthcare, what their outcomes are, and how costeffective they are,” said Ms Coaxum.

Quality determinations that are

RHEUMATology Practice Management

I December 2013

inferred from claims data, as has been done traditionally, does not provide an accurate picture of out­ comes, she said. Health profession­ als not currently participating in PQRS were supposed take action by October 15, 2013, to avoid a 1.5% penalty from Medicare in 2015.

According to the Centers for Medicare & Medicaid Services (CMS), providers can report their quality information to CMS on their Medicare Part B claims, to a qualified PQRS registry, to CMS via a quali­ fied EHR product, or to a qualified PQRS EHR data submission vendor.

Physicians who meet PQRS reporting deadlines currently receive a 0.5% Medicare bonus payment. In 2015, the bonus payments will be replaced by a 1.5% penalty for those who do not meet the deadlines, which increases to 2% in 2016.

Analyze Your Contracts Now is also the time to start ana­ lyzing your managed care contracts with the intent of renegotiation based on your patient demographic mix, said Ms Coaxum. “Providers need to start analyzing the types of patients they have and the types of insurance they carry, their volumes, and how much it costs them to deliv­ er care to these groups,” she said.

“Many times practice administrators don’t focus much on the financial viability of their practices, and we want to change that mindset.”

In some instances, joining an accountable care organization may make sense financially, and may help a practice meet their report­ ing requirements or with admin­ istrative processing. “It sometimes provides them the leverage that they potentially need to work with contract negotiations and get more reimbursement in some areas,” Ms Coaxum said. l

PROCESS IMPROVEMENTS TO ENHANCE PATIENT CARE™

Call for submissions

PRACTICE MANAGEMENT

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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_121313

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