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Access to Care Is Needed in The Role of Clinical Pathways Private Practice A Conversation with Shane Anderson, MD in Patient Care VBCR Perspective

By Gary R. Feldman, MD Dr Feldman is Medical Director at Pacific Arthritis Care Center, Los Angeles, CA; and President, California Rheumatology Alliance

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s healthcare reform continues to unfold, an increasing amount of pressure is being placed on payers, providers, and patients to address the rising cost of care. Greater attention is being paid to patients with inflammatory arthritis and other autoimmune conditions treated with chronic biologic therapies. Although the cost of many healthcare services is stabilizing, specialty pharmacy costs continue to rise at an unsustainable rate.1 Rheumatoid arthritis has become one of the most expensive chronic illnesses to treat based on average patient

Gary R. Feldman, MD cost. This is due to an increasing percentage of patients on biologic therapies and these agents’ continuing rise in cost.2 Payers are becoming more aggressive in deploying strategies to control the cost of care. Such measures do not always consider efficacy or

Continued on page 22

Long-Term Safety of Rituximab Shown in Pooled Analysis By Rosemary Frei, MSc Whistler, BC—Rituximab plus methotrexate is well tolerated in patients with moderate-to-severe, active rheumatoid arthritis (RA) who take the medications for up to 11 years, ac-

cording to recent research. The results from the analysis of pooled observational data from 8 randomized clinical trials, 2 long-term open-label trial extensions, and 1 Continued on page 20

Charlotte, NC—At the end of the North Carolina Rheumatology Association (NCRA) annual meeting, Shane Anderson, MD, President of the Association discussed the meeting, challenges he faces in his practice as well as his thoughts on ICD-10. Dr Anderson is a Practicing Rheumatologist in Greensboro, North Carolina, and has been the president of the association for the past 2 years. This year’s meeting was a 2-day event held at the Ballantyne Resort

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Costs of Biologic Drugs Outweigh Reductions in Swedish Healthcare Services By Alice Goodman

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he total fixed costs of treating patients with rheumatoid arthritis (RA) in Sweden increased by 32% between 1990 and 2010, years that encompass the time period when biologic therapies became available. These results of a large, population-based registry study suggest that hospitalization and other indirect

costs associated with RA have not been reduced enough to offset the increased cost of more expensive drugs (Kalkan A, et al. Rheumatology [Oxford]. 2014;53:153-160). Identifying the Source of the Costs Despite the availability of guideContinued on page 24

inside VALUE PROPOSITIONS. . . . . . . . . . . Nurse-led methotrexate clinic is efficient and cost-effective

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GOUT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Hyperuricemia may be associated with hematospermia Personalized Medicine in Rheumatology™. . . . . . . . . . . . . . . . . . . .

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New rheumatoid arthritis susceptibility locus identified by UK genome-wide association studies

© 2014 Engage Healthcare Communications, LLC

and included both local and national experts on various rheumatology topics. In particular, Robert T. Keenan, MD, MPH, Duke University School of Medicine Division of Rheumatology, talked about new guidelines for gout. Megan Clowse, MD, Duke University Medical Center, discussed pregnancy and rheumatic disease, and an inspiring talk by Wayne Sotile, PhD, Center for Physician Resilience and Renewal, focused on thriving through change

RHEUMATOID ARTHRITIS . . . . 12 Regional variations exist in rheumatoid arthritis treatment and outcomes

AUTOIMMUNE DISEASES . . . . . . 17 Human papilloma virus vaccination rates dismal in patients with autoimmune diseases OSTEOPOROSIS. . . . . . . . . . . . . . . . . . . 17 Icelandic company streamlining osteoporosis management decision THE Rheumatology NURSE™ . . . . . . 19 Mid-level providers proficient in rheumatology practice IN THE LITERATURE . . . . . . . . . . . 22 Abatacept biologically active and well tolerated in patients with lupus nephritis


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


In This Issue Value-Based Care in Integrating Rheumatologists, NPs/PAs, Practice Managers & Payers

Publishing Staff

Senior Vice President/Group Publisher Nicholas Englezos nenglezos@the-lynx-group.com Director, Client Services Zach Ceretelle zceretelle@the-lynx-group.com Editorial Directors Dalia Buffery dbuffery@the-lynx-group.com Frederique H. Evans fevans@the-lynx-group.com Associate Editor Lara J. Lorton Editorial Assistants Jennifer Brandt Cara Guglielmon Senior Production Manager Lynn Hamilton Production Manager Melissa Lawlor

The Lynx Group President/CEO Brian Tyburski Chief Operating Officer Pam Rattananont Ferris Vice President of Finance Andrea Kelly Human Resources Jennine Leale Associate Director, Content Strategy & Development John Welz Associate Editorial Director, Projects Division Terri Moore Director, Quality Control Barbara Marino Quality Control Assistant Theresa Salerno Director, Production & Manufacturing Alaina Pede Director, Creative & Design Robyn Jacobs Creative & Design Assistant Lora LaRocca Director, Digital Media Anthony Romano Web Content Managers David Maldonado Anthony Trevean Digital Programmer Michael Amundsen Meeting & Events Planner Linda Sangenito Senior Project Managers Andrea Boylston Jini Gopalaswamy Project Coordinators Deanna Martinez Jackie Luma IT Specialist Carlton Hurdle Executive Administrator Rachael Baranoski Office Coordinator Robert Sorensen Engage Healthcare Communications, LLC 1249 South River Road, Ste 202A Cranbury, NJ 08512 Telephone: 732-992-1882 Fax: 732-992-1881 Value-Based Care in Rheumatology, ISSN (applied), is published 6 times a year by Engage Healthcare Com­ munications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Copyright © 2014 by Engage Health­ care Communications, LLC. All rights reserved. Value-Based Care in Rheumatology is a 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 pho­ tocopy, recording, or any informational storage and retrieval system, without written permission from the publisher. Print­ ed in the United States of America. The ideas and opinions expressed in Value-Based Care in Rheumatology do not necessarily reflect those of the editorial board, the editors, or the publisher. Publication of an adver­ tisement or other product mentioned in Value-Based Care in Rheumatology 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.

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VALUE PROPOSITIONS

OSTEOPOROSIS

Nurse-led methotrexate clinic is efficient and cost-effective More…

Osteoporosis management decision streamlined

GOUT Gout is curable More…

OSTEOARTHRITIS More efforts needed when disseminating osteoarthritis guidelines

THE Rheumatology NURSE™

Mid-level providers proficient in rheumatology practice

Personalized Medicine in Rheumatology™

New RA susceptibility locus identified More…

FDA UPDATE

RHEUMATOID ARTHRITIS

CRA ANNUAL MEETING

Apremilast approved for psoriatic arthritis

Regional variations in RA treatment More…

Low RA disease activity at 6 months associated with remission at 12 months More…

JUVENILE IDIOPATHIC ARTHRITIS

LUPUS Immunosuppressants can be discontinued in patients with lupus

Updated juvenile idiopathic arthritis recommendations unveiled

RHEUMATOLOGY UPDATE

AUTOIMMUNE DISEASES Human papilloma virus vaccination rates dismal in patients with autoimmune diseases

Automatic prediction of RA disease activity from EMR becoming a reality More…

VBCR Editorial Advisory Board Howard B. Blumstein, MD Rheumatology Associates of Long Island, Smithtown, NY Scott Breidbart, MD Chief Medical Officer Empire BlueCross BlueShield New York, NY Gary R. Feldman, MD, FACR Private Practice, Pacific Rheumatology, Los Angeles, CA Gary L. Johnson, MD, MS, MBA Regional Medical Director Humana, Inc., Madison, WI Atheer A. Kaddis, PharmD Vice President, Managed Markets Diplomat Specialty Pharmacy Swartz Creek, MI Shelly P. Kafka, MD, FACR Rheumatologist, Mountain State Rheumatology, Medical Director, Mountain State Clinical Research, Clarksburg, WV Clinical Assistant Professor West Virginia University School of Medicine, Morgantown, WV James T. Kenney, Jr, RPh, MBA Pharmacy Operations Manager Harvard Pilgrim Health Care Wellesley, MA

Gary M. Owens, MD President, Gary Owens Associates Philadelphia, PA

Muhammad Asim Khan, MD Professor of Medicine Case Western Reserve University Cleveland, OH

Kim A. Papp, MD, PhD Founder and President Probity Medical Research Waterloo, Ontario, Canada

John Kolstoe, MD Kolstoe Rheumatology: Musculoskeletal Medicine East Lansing, MI Randall Krakauer, MD, FACP, FACR National Medical Director Medicare, Aetna, Princeton, NJ

Edmund J. Pezalla, MD, MPH National Medical Director for Pharmacy Policy and Strategy Aetna, Hartford, CT

Joel M. Kremer, MD Pfaff Family Professor of Medicine Albany Medical College Director of Research, Center for Rheumatology, Albany, NY Alan Menter, MD Director, Baylor Psoriasis Research Center Dallas, TX Matthew Mitchell, PharmD, MBA Manager, Pharmacy Services SelectHealth, Murray, UT Lynn Nishida, RPh Director, Clinical Services Catamaran Center of Excellence Northwest Region, Portland, OR

Jeffrey S. Peller, MD Practicing Rheumatologist Harbin Clinic/Rheumatology Rome, GA

William A. Sunshine, MD, FACR Rheumatology Practice Boca Raton & Delray Beach, FL Ronald van Vollenhoven, MD, PhD Associate Professor Karlinska University Hospital Solna Stockholm, Sweden F. Randy Vogenberg, RPh, PhD Principal, Institute of Integrated Healthcare, Greenville, SC

Mission Statement

Value-Based Care in Rheumatology provides a forum for payers, providers, and the entire rheumatology team to consider the cost-value issues particular to rheumatology treatments. This unique focus is achieved through news coverage from major rheumatology meetings and the rheumatic diseases literature, supplemented with commentaries and perspectives from those involved in evaluating therapies, treating patients, and paying for care. Contact Information: For subscription information please contact: Telephone: 732-992-1880 Fax: 732-992-1881. Permission requests to reprint all or part of any article published in this publication should be addressed to editorial@engagehc.com. Address all editorial queries to: editorial@engagehc.com. Telephone: 732-992-1882 Fax: 732-992-1881. Postmaster: Correspondence regarding subscriptions or change of address should be directed to CIRCULATION DIRECTOR, Value-Based Care in Rheumatology, 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.

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Value Propositions Nurse-Led Methotrexate Clinic Efficient, Cost-Effective

To facilitate the transition to subcutaneous methotrexate, study investigators sought to introduce a nurse-led methotrexate clinic into a district general hospital and thereby make the best use of the advanced knowledge and skills of rheumatology specialty nurses, as well as empower patients and improve their experience, and contribute to cost-savings for a hospital trust. As part of the project, pharmacists, clinicians, and administrative and support staff met during the span of 4 months and discussed ways to introduce changes, procedures to follow, and safety issues for patients. Services were reviewed 1 year prior and 1 year after the implementation of the initiative. The investigators found that the number of patients with rheumatoid arthritis who switched to methotrexate increased by 80% (P = .049). “This project demonstrated that not only do nurse specialists have the skills to make clinical decisions and judgments, prescribe medications and escalate therapies with no detriment to the patient, but also that this practice can lead to a more efficient and effective service, at reduced cost,” the investigators concluded. Fitzgerald P, et al. Musculoskeletal Care. 2014 Apr 7; Epub ahead of print

Taking Patient Preferences into Account When Selecting Anti-TNF

Using anti–tumor necrosis factor (TNF) medications for the treatment of patients with rheumatoid arthritis, as well as other chronic inflammatory conditions such as psoriasis, represent a large and growing healthcare expenditure. As part of a cross-sectional survey and claims study based on claims in the HealthCore Integrated Research Database, investigators examined patient preferences regarding anti-TNF agents and mode of administration options. Patients were identified based on whether they received infliximab (intravenous group) or adalimumab, etanercept, or certolizumab pegol (subcutaneous group). Patients were diagnosed with conditions for which these agents were indicated by the US Food and Drug Administration between March 2012 and August 2012. Patients in the subcutaneous group had a higher preference for the administration route they were using compared with patients in the intravenous group. Specifically, 89.9% of the subcutaneous group preferred the subcutaneous route of administration, whereas 71.8% of the intravenous group preferred the intravenous route (P <.001). The global treatment satisfaction scores were similar in both groups, and the reported likelihood of patients discussing alternative anti-TNF options with their physician was low (P = .366). “An opportunity for patient education exists, because conversations with physicians about alternative anti-TNF therapies and administration appear to be lacking,” according to the investigators. There was a strong correlation between the route of administration in use and the preference. Results showed that patients had stronger preferences for subcutaneous routes than for intravenous routes. Sylwestrzak G, et al. Am Health Drug Benefits. 2014;7(2):71-81

Alternate RA Therapy Shows Promise in Animal Model

Although tumor necrosis factor (TNF)-alpha inhibitors are associated with significant relief among patients with rheumatoid arthritis (RA), a need exists for safe, oral, cost-effective therapy. A group of investigators evaluated the anti-inflammatory and anti-arthritic effects of a polyherbal formulation (BV-9238) and its ability to inhibit TNF-alpha and nitric oxide (NO) production in lipopolysaccha-

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ride-stimulated RAW 264.7 mouse macrophage cell line. Overall, it was found that the compound reduced TNF-alpha and NO production without cytotoxic effects and, when tested in adjuvant-induced arthritis and carrageenan-induced paw edema rat animal models, significantly reduced arthritic scores in both models. This compound may be promising as an alternate therapy for inflammatory disorders, such as RA, where TNF-alpha and NO play significant roles, according to the study authors. Debendranath D, et al. Phytother Res. 2014 Apr 7; Epub ahead of print

HCQ Lipid Profile, Toxicity, and Costs Favorable in RA

In a cohort from the Veterans Affairs Rheumatoid Arthritis (VARA), investigators sought to examine lipid profiles among patients with rheumatoid arthritis (RA) who used hydroxychloroquine (HCQ) compared with patients who did not use it. Participants of the VARA cohort tended to be predominantly elderly, white men; 1011 had lipid profiles. Overall, 11.6% used statins, 33.5% had diabetes mellitus, and 31.2% had cardiovascular events. The investigators observed that patients who used HCQ (n = 150) tended to be older, had longer RA disease, and lower disease activity compared with nonusers. In addition, HCQ users had more frequent optimum lipid profiles including total cholesterol/high-density lipoprotein (HDL), and HDL/ low-density lipoprotein (LDL) ratios (P ≤.001), but not including HDL. Other measures evaluated, including National Cholesterol Education Program Adult Treatment Panel III target levels, were reached by more patients taking HCQ compared with nonusers. HCQ use over the course of 3 months is associated with better lipid profiles, relatively lower costs and toxicity in patients with RA, according to recently published data. Continued use, the investigators added, regardless of treatment regimen, should be taken under consideration. Kerr G, et al. Arthritis Care Res (Hoboken). 2014 Apr 1; Epub ahead of print

Shared Decision-Making in JIA

As the number of treatment options increases for the treatment of patients with juvenile idiopathic arthritis (JIA), there is a need for improved clinician–parent communication. Using shared decision-making, clinicians can share information about options available, while patients and their parents can discuss their goals and preferences. “Together, a treatment plan is developed that is the best fit for the individual and their family,” according to the investigators. Using the Pediatric Rheumatology Care and Outcomes Improvement Network (PR-COIN)—a network aimed at improving outcomes of JIA care using quality improvement methods—the investigators developed tools to facilitate shared decision-making for patients with JIA and their families. In particular, issue cards were developed based on qualitative interviews with clinicians and care providers, as well as direct observation of clinical encounters. Prototype issue cards were introduced in the clinic using Plan-Do-Study-Act (PDSA) cycles. Feedback for revisions was solicited from PR-COIN members using electronic surveys, webinars, and direct observations. How soon therapies will take effect, how often they are given, in addition to side effects, costs, and how long patients will need to stay on the medication, as well as other considerations were the most important attributes identified to discuss. Overall, 18 revisions were made to the issue cards, at which point they were deemed acceptable for regular use. “Our ultimate goal is to drive improvement in child JIA outcomes by reliably engaging patients/parents in [shared decision-making] to select a medication that is a good fit,” the investigators concluded. Dewitt EM, et al. Arthritis Rheumatol. 2014;66(Suppl 11):S232-S233

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Gout

Hyperuricemia May Be Associated with Hematospermia By Rosemary Frei, MSc Vancouver, British Columbia—A study of 143 men with hematospermia revealed that approximately 15% also had hyperuricemia. Clinician-researchers at Assiut University Hospital, Egypt, undertook the case review because they noticed that a lot of patients with hematospermia also had elevated plasma uric acid level, or hyperuricemia (>7 mg/dL). They felt that hyperuricemia may have been overlooked in previous studies of hematospermia. The team, led by Adel Kurkar, MD, Urologist, analyzed information from each of the 143 cases of hematospermia that presented to the hospital’s outpatient clinic between July 2005 and July 2012. The information gathered at the time of presentation included urinalysis, urine and semen cultures for specific and nonspecific infections,

bleeding profile, liver function tests, serum uric acid, prostate-specific antigen, abdominal ultrasound, plain x-ray of the urinary tract, semen analysis, examination and culture for expressed prostatic secretion, transrectal ultrasound with or without biopsy, computed tomography scan, magnetic resonance imaging, and urethrocystoscopy. The most common concomitant disorders included schistosomiasis (21.6%), hyperuricemia (15.38%), idiopathic (14.7%), chronic prostatitis (8.4%), and tuberculosis (8.4%). At presentation, the mean age of patients with hyperuricemia was 32 years. They reported episodes of hematospermia for 2 to 8 months before they came to the hospital; average serum uric acid level was 9.2 mg/dL (range, 7.6-11.4 mg/dL). Furthermore,

15 patients had painful ejaculation, 14 had lower-urinary-tract symptoms, 12 had arthralgia, 10 had urate crystals in the urine, 7 had urate crystals in the semen, and 5 had dotted prostate calcifications on transrectal ultrasound.

An assessment of serum uric acid levels [is recommended] in men presenting with hematospermia, especially those with gout symptoms. —Ahmad A. Elderwy, MD

The physicians prescribed allopurinol 300-mg tablets twice daily for 8 weeks, followed by 300 mg daily.

They analyzed the patients’ semen once monthly until the symptoms resolved, which took between 1 and 4 months, and they continued to analyze the semen at 3-month intervals for another year to check for recurrences. Coinvestigator Ahmad A. Elderwy, MD, Urologist, Assiut University Hospital, and Visiting Pediatric Urology Fellow, Seattle Children’s Hos­ pital, WA, told Value-Based Care in Rheumatology, after he and his colleagues presented the information at the 2013 Société Internationale d’Urologie annual meeting, that they recommend an assessment of serum uric acid levels in men presenting with hematospermia, especially those with gout symptoms. In addition, the patients should be referred to a rheumatologist, Dr Elderwy said. n

Gout Is Curable By Frederique Evans, MBS

Risk Factors and Stages Citing data analyzed from the Framingham Heart Study—a study that examined the relationship between risk factors and the incidence of gout in 2476 women and 1951 men over a 52-year period—Dr Keenan explained that higher levels of serum uric acid increase the risk of gout in a graded manner among women, but the rate increase is lower in men (Bhole V, et al. Arthritis Rheum. 2010; 62:1069-1076). In addition, he discussed the different stages of gout, including asymptomatic hyperurice-

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mia, acute gouty arthritis, intercritical gout, and chronic tophaceous gout. “[Intercritical gout] is a very impor­ tant, underappreciated, stage of gout,” Dr Keenan stated. “This is really where, as you will see, a lot of destruction and joint damage occurs.” All gout is tophaceous gout, he added. “In my mind—and this is where I differ with the guidelines—if you have 1 gout attack, you have trophaceous gout,” according to Dr Keenan. “Whether or not you see tophi or the patient has another attack in 5 years, if they have 1 attack, especially if it’s crystal-proven, then the patient has tophaceous gout.” ACR Guidelines Taking a closer look at the American College of Rheumatology (ACR) guidelines for the management of acute and chronic gout, Dr Kennan suggests using a serum uric acid target level of <5.0 mg/dL for all of his patients, instead of the recommended target level of <6.0 mg/dL for most patients and <5.0 mg/dL in some

READER POLL

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populations. That way, he explained, there is room for patients if their diet fluctuates, for example. He also discusses the importance of patient education when continuing ULT during flares and prophylaxis against flares. He cited the example of patients coming into his office concerned they were experiencing an allergic reaction to allopurinol because they experienced a flare, when in fact that is an indication that the therapy is working. “It boils down to education and making sure that the patient understands what to expect from their medication,” Dr Keenan stated. When to start prophylaxis of acute gout is controversial. The ACR guidelines recommend starting 1 to 2 weeks prior to the initiation of ULT. “I usually start, depending on the patient, a week or 2 ahead,” he explained. Among agents used for acute gout prophylaxis, Dr Keenan spent some time discussing colchicine toxicity. “I have seen more people going to the emergency room due to colchicine toxicity than anything else,” he em-

phasized. Colchicine toxicity is associated with gastrointestinal events, bone marrow suppression, neuromyopathy, cardiac toxicity, liver toxicity, and rarely death. Spreading Awareness “Gout is curable,” Dr Keenan emphasized. The first step in lowering a patient’s serum urate levels is through prevention, including education, changing diet and lifestyle, as well as controlling comorbidities. More patients then are being treated probably need ULT, he added. These patients have chronic kidney disease stage 2 or higher with 1 or more attacks, patients with clinically evident tophi, 2 more attacks in a 12 month period, and/or a history of urolithiasis. Dr Kennan suggested that under treatment can lead to significant chronic gouty arthropathy and disability. ACR guidelines are just that, he reminded the audience, and individualized therapy should be used for patients to reach their appropriate serum urate goals. n

£ Yes DO YOU TREAT YOUR PATIENTS ü WITH GOUT AGGRESSIVELY? £ No

VBCR_ReaderPoll041614

Charlotte, NC—How many rheumatologists can say they can cure gout? Not many can confidently say so, according to an informal poll taken during the 2014 North Carolina Rheumatology Association annual meeting. “The key in treating gout flares is that when you start therapy is more important than which agent you use,” stated Robert T. Keenan, MD, MPH, Assistant Professor of Medicine, Division of Rheumatology, Duke University School of Medicine. Other key factors in treatment include selecting an agent based on patient comorbidities; starting treatment as soon as possible; avoiding attacks at the earliest hint of a flare; and educating patients on the role of diet, risk of flares upon initiation of urate-lowering therapy (ULT), and adherence.

Based on the results of the February Reader Poll, 100% of the voters reported that they treated gout aggressively enough. Online polls are available on our website.

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Personalized Medicine in Rheumatology

New RA Susceptibility Locus Identified By Alice Goodman

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previously unknown locus for rheumatoid arthritis (RA) susceptibility has been identified by researchers from the United Kingdom involved in the genome-wide association studies (GWAS), according to a recent study (Orozco G, et al. Arthritis Rheum. 2014;66:24-30). The new locus (rs1043099), located on chromosome 22q12 was found in an expanded cohort of UK patients; 32 RA loci have already been identified. These 30-plus gene regions account for <50% of the total genetic heritability of RA, said the investigators, but may eventually lead to therapeutic approaches. “Increasing the number of known disease loci will facilitate the estimation of disease risk, potentially allow early intervention in high-risk groups, possibly informing prognosis, and, ultimately, aiding in the discovery of novel targets for pharmacologic therapy,” wrote senior investigator Stephen Eyre, PhD, Senior Research Fellow, Arthritis Research UK Epi­ demi­ ology

Unit, University of Manchester, United Kingdom, and colleagues. The expanded UK cohort of RA cases and controls added 1361 patients with RA and 2334 healthy controls to the existing UK GWAS base; in all, 3034 patients with RA and 5271

“Using bioinformatics analysis, we showed that rs1043099 and its correlated SNPs have potential regulatory activity [in RA].” —Stephen Eyre, PhD, and colleagues

healthy controls were available for analysis. The additional cases and controls expand the power to identify novel RA risk loci in this UK population, the investigators stated.

The genotype data for RA cases and association testing of more than 1.8 million single-nucleotide polymorphisms (SNPs) were evaluated. The results of the bioinformatics analyses showed that 6 novel RA loci previously associated with other autoimmune diseases, including type 1 diabetes and inflammatory bowel disease, have a suggestive association with susceptibility to RA (P <.001). Of these 6 associated loci, 2 were validated for association with RA. For rs1043099, validation significance reached. This locus exceeded genome-wide levels of significance in the combined analysis. There is also evidence in publicly functional annotation data suggesting that rs1043099 and its correlated SNPs may have regulatory activity in RA. The newly found SNP is located within a gene of unknown function, GATSL3. “Using bioinformatics analysis, we showed that rs1043099 and its correlated SNPs have potential regulato-

at a glance ➤ rs1043099 is novel RA locus located on chromosome 22q12 ➤ Although 32 RA loci have already been identified, it accounts for <50% of the total genetic heritability of RA ry activity [in RA]….Further functional studies will be required to determine which of the SNPs is causal and to elucidate the mechanisms of action of each SNP,” stated Dr Eyre and colleagues. The findings reported herein support the view that extending the size, and thus the power, of RA GWAS can lead to the discovery of new genes implicated in the development of the disease. There is hope that this accumulation of knowledge will have clinical importance in the future. n

Novel Plasma Cell Signature May Be Useful in a Range of Rheumatic Disorders By Alice Goodman

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newly developed plasma cell (PC) 5-gene signature accurately measures PC levels in patients with scleroderma and other autoimmune diseases, including lupus and rheumatoid arthritis (RA). This work paves the way for identification of subsets of patients who may benefit from PC-depleting therapy, according to investigators (Streicher K, et al. Arthritis Rheumatol. 2014;66: 173-184). “At this point, additional studies are needed to fully understand the utility of the PC signature and whether or not measuring PC levels at baseline before treatment or evaluating the extent of PC depletion following treatment would have an impact on clinical care in autoimmune diseases,” lead author Katie Streicher, PhD, MedImmune, Gaithersburg, MD, told Value-Based Care in Rheumatology. “Plasma cells are responsible for secreting autoantibodies that are critical to the pathogenesis of autoimmune diseases,” she added. “Previously, the impact of different treatments on this cell population has been difficult to

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“Our work not only developed a reliable method for monitoring this cell population but also identified diseases where PCs may be especially important, including lupus, RA, and scleroderma.” —Katie Streicher, PhD

measure in large clinical trials. Our work not only developed a reliable method for monitoring this cell population but also identified diseases where PCs may be especially impor­ tant, including lupus, RA, and scleroderma,” Dr Streicher continued. A sensitive gene expression–based method was developed to measure

PCs, which is not readily done using flow cytometry. Using whole genome microarray analysis of subsets of cellular fractions, the investigators were able to identify 5 genes predominantly expressed in PCs: IGHAI, IGJ, IGKC, IGKV4-1, and TNFRSF17. Then, they assessed the ability of the PC-enriched genes to be reliably detected in whole blood to verify that this signature would have routine applicability in a clinical setting. The sensitivity and specificity of this signature was validated using ex vivo experiments and its utility was confirmed using samples from patients with scleroderma enrolled in a phase 1 dose-escalation trial of MEDI551, an anti-CD19 monoclonal antibody. MEDI-551 exerted a robust reduction of the PC signature in whole blood, with maximum and sustained PC depletion to day 85 posttreatment. Patients in the placebo group had little or no change in the PC signature at all time points. This is an early study with small numbers of patients, but suggests that the concept of PC depletion has promise. april 2014

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In addition, the investigators also identified multiple autoimmune diseases with increases in the PC signature in blood and diseased tissue, which is possibly indicative of a relationship between PCs and the pathogenesis of these diseases. Increased levels of PCs were observed in 30% to 35% of patients with lupus and RA. “Many therapies [for autoimmune diseases] that are FDA [US Food and Drug Administration]-approved or in development are not specifically designed to target the PC. However, using the PC signature we developed allows sensitive and specific assessment of various treatments on PCs in large clinical trials,” Dr Streicher explained. “This highlights the importance of measuring PCs prior to therapy and, potentially, understanding their pattern of depletion and recovery following B-cell depletion therapy,” Dr Streicher concluded, citing recent findings that patients with RA who have high PC plasma levels were less likely to respond to treatment with anti-CD20 B-cell–depleting therapy. n

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Rheumatoid Arthritis

Care of Patients with RA Varies Across the United States By Phoebe Starr

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atients with rheumatoid arthritis (RA) receive different care depending on where they live, and this has an impact on their outcomes, according to a study presented at the 2013 American College of Rheumatology (ACR) Meeting. Patients with RA who live in the Mountain region are treated according to ACR guidelines more often than patients who live in other regions of the United States. In addition, these patients also have the best functionality, whereas patients living in the East South Central region are least likely to receive ACR guideline–recommended therapy, and have the worst functionality. Senior investigator Kathy Annunziata, MA, Vice President, Research Services for Health Outcomes, Kantar Health, Princeton, NJ, and colleagues hope that this study, and others like it that reveal suboptimal regional variations in practice and

outcomes, will stimulate new approaches that improve care in parts of the country where such improvement is warranted. ACR guideline–recommended

US National Health and Wellness Survey—a cross-sectional, self-administered, internet-based look at the general US adult population—and included 1088 respondents with a

Patients with RA who live in the Mountain region are treated according to ACR guidelines more often than patients who live in other regions of the United States, and also have the best functionality, whereas patients living in the East South Central region are least likely to receive ACR guideline–recommended therapy, and have the worst functionality.

treatment for RA includes nonbiologic or biologic disease-modifying antirheumatic drugs (DMARDs). The investigators used data from the 2012

self-reported diagnosis of RA. Patients were asked to indicate their current treatments which were categorized as follows: biologics; nonbio-

Regional Variations Exist in RA Treatment and Outcomes Susan C. Bolge, PhD, Janssen Scientific Affairs, LLC, Horsham, Pennsylvania, comments on her study “Regional Variations in Rheumatoid Arthritis Treatment and Health Outcomes Across the United States”

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mplementation of the Patient Protection and Affordable Care Act has led to an increasing focus on improving quality of care and patient outcomes. As a result, there is increasing interest by physicians and payers in understanding the current status of quality of care in the existing healthcare setting and improving quality where needed. Current American College of Rheumatology (ACR) treatment guidelines recommend the use of nonbiologic or biologic disease-modifying antirheumatic drugs (DMARDs) to target low disease activity or remission in all patients with early rheumatoid arthritis (RA) and established RA.1 Both the ACR and the National Quality Forum have listed the prescribing of a DMARD as a specific measure of quality of care for patients with RA.2,3 Our study demonstrates that the quality of care received by patients with RA in the United States differs by geographic region. Nearly all patients with moderate-to-severe dis-

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ease should be treated with nonbiologic or biologic DMARD therapy to treat signs and symptoms, as well as to slow disease progression.1 However, while the majority of patients in all regions self-classified their disease as moderate-to-severe, rates of DMARD use were far from universal and varied widely from 40% to 60% in different geographic regions. Of particular interest is the association between DMARD use and patient health outcomes within and across regions. Regions with low rates of DMARD use also have poorer patient outcomes including poorer physical and mental functioning, greater work productivity loss and activity impairment, and greater utilization of healthcare resources. Regions with high rates of DMARD use also have better patient outcomes. Although this study was not designed to determine if better quality of care were associated with better patient outcomes, there appears to be a strong association between quality

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and outcomes. Across the United States, there are regional variations in quality of care and patient outcomes for RA. Initiatives to improve quality of care may benefit from a regional approach that considers these existing variations. Regional approaches may best optimize healthcare systems to better achieve the triple aim of improving patient experience and quality of care, improving population health, and reducing healthcare costs.4 n References

1. Singh JA, Furst DE, Bharat A, et al. 2012 update of the American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Cares (Hoboken). 2012; 64(5):625-639. 2. National Quality Forum. disease modifying anti-Rheumatic drug therapy for rheumatoid arthritis. Steward: National Committee for Quality Assurance. www.qualityforum.org/QPS/0054. Accessed March 24, 2014. 3. American College of Rheumatology. Rheumatoid arthritis quality indicators. www.rheumatology.org/Practice/Clinical/ Quality/Rheumatoid_Arthritis_Quality_Indicators/. Accessed March 24, 2014. 4. Institute for Healthcare Improvement. The IHI Triple Aim. www.ihi.org/engage/initiatives/Triple Aim/Pages/default.aspx. Accessed March 24, 2014.

logic DMARDs without biologics; other medication classes, including steroids, opioids, and nonsteroidal anti-inflammatory drugs but without biologics or nonbiologic DMARDs; and untreated. Outcomes were tallied according to the 36-item Short Form Health Survey, version 2 (SF36v2), a widely used tool for assessing the health of general and specific populations; the Work Productivity and Activity Impairment (WPAI) questionnaire; and patients’ use of healthcare resources in the previous 6 months. By census regions, the use of biologics or nonbiologic DMARDs was highest in the Mountain region (60%) and in the Pacific region (57%). Other regional uses of ACR guideline–recommended treatment were 56% in the West South Central region, 54% in the West North Central region, 53% in the Middle Atlantic region, 52% in the East North Central region and the South Atlantic, and lowest in New England (42%) and the East South Central region (40%). These last 2 regions also had the most undertreated patients—19% and 24%, respectively. The East South Central region had not only the lowest adherence to ACR guideline–recommended treatment, but also was among the regions with the poorest physical and mental function, the most activity impairment, and the greatest proportionate use of the emergency department and hospital. Self-identification of RA as “mild” was highest among patients in the Pacific region (32%). A “severe” rating was highest among patients in the West South Central (30%) and West North Central (28%) regions. Although physical function was poor among patients with RA in every region of the United States, geographic variations were evident in patients’ mental function. Mean mental summary scores on the SF-36v2 ranged from a high of 47.0 in the West North Central region to a low of 43.3 in the East South Central region. Employed patients with RA living in New England reported the least work impairment on the WPAI questionnaire (WPAI score, 21.0), whereas those residing in the East South Central and Pacific regions had the most work impairment (WPAI score, 31.6 and 53.0, respectively). n VOL. 3

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PROCESS IMPROVEMENTS TO ENHANCE PATIENT CARE™

YOUR COMPLIMENTARY SUBSCRIPTION IS ONLY A CLICK AWAY

PRACTICE MANAGEMENT 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 travel­weary as I was, my mind was still in sponge­mode—ready Continued on page 10

From the Editor

Sharing Our Success

By Iris Nichols President, National Organization of Rheumatology Managers

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

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

NORM Meeting Proceedings

Receive timely information on the latest developments in rheumatology practice management to assist you in your daily roles and responsibilities. Sign up now for Rheumatology Practice Management.

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

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

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

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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

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Rheumatoid Arthritis

Issues Explored in Treating-to-Target Strategy By Alice Goodman San Diego, CA—The concept of “treatto-target” (T2T) is key to optimizing disease control and outcomes in patients with rheumatoid arthritis (RA). T2T entails selecting an appropriate target, incorporating an assessment of synovitis; aligning the patient’s and treating physician’s goals; discussing potential limitations to reaching target, such as comorbidity and cost; and monitoring disease activity often at first, adjusting treatment accordingly. Outcomes are optimized when biologics are initiated early for slow or no response. “Outcomes in RA have markedly improved over the past decade. This is due in part to earlier diagnosis, more stringent criteria for remission, and emphasis on early response to treatment. Much progress can be attributed to T2T, which is now incorporated into practice recommendations,” according to Vivian P. Bykerk, MD, Hospital for Special Surgery, and Associate Professor of Medicine at Weill Cornell Medical College, New York City. Assessing the Feasibility of T2T The Tight Control for Rheumatoid Arthritis (TICORA) study was influential in adopting the T2T strategy, Dr Bykerk explained (Grigor C, et al. Lancet. 2004;364:263-269). The investigators randomized 55 patients with RA to intensive therapy aimed at the target of no swollen joints versus usual care; remission was achieved in 65% of patients in the intensive therapy arm versus 9% of patients in the usual care arm (P <.001). “T2T was basically a paradigm shift, adapting therapy according to measurement of disease activity until the target is reached,” she explained. “If you are going to aim for remission as a target, you will need to see patients frequently, assess them often, and adapt therapy accordingly. We all know remission is not possible for every patient, so in some patients we aim for the target of low disease activity.” A case history illustrates the importance of getting on the same page with the patient. A 39-year-old female patient with a 5-year history of cyclic cit­ rullinated peptide-positive erosive RA, had 8 swollen and 12 tender joints, severe pain, and poor function on physical examination. Comorbidities included a positive skin test for tuberculosis, a positive hepatitis B test, and a thin skeleton with a maternal history of hip fracture. She had high disease activity on every measure: Disease Activity Score (DAS)28, 5.4; Sim-

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plified Disease Activity Index (SDAI), 32; and Routine Assessment of Patient Index of Disease III, 10. “This patient and I were not on the same page. She was afraid of drugs and wanted to be drug-free, while I knew that she had to be on therapy, either triple therapy or a biologic. This is a very important point, taking the time to make sure that your goals are aligned with the patient’s goals,” said Dr Bykerk. “She is exactly the patient we would want to start on a biologic according to the current guidelines.” However, patients like this one raise several questions: Is it feasible to T2T? With her comorbidities, how soon is a target achievable? How often should disease activity be assessed? At what point should other therapies be added, including biologics? What is the optimal strategy until target is reached? DMARDs and Biologics Dr Bykerk emphasized that subcutaneous methotrexate, although effective, takes time to reach low disease activity, and oral methotrexate and classic triple disease-modifying antirheumatic drugs (DMARDs) also take time to achieve low disease activity. The Treatment of Early Aggressive Rheumatoid arthritis (TEAR) study showed that low disease activity is achieved more quickly in patients with severe early RA using immediate intensive therapy compared with delayed step-up therapy (Moreland LW, et al. Arthritis Rheum. 2012;64:2824-2835).

“T2T was basically a paradigm shift, adapting therapy according to measurement of disease activity until the target is reached.” —Vivian P. Bykerk, MD

“If you don’t aim for a target, you won’t reach it. It is really important to pick a target and aim for it,” she emphasized. “Initial DMARD therapy takes time to work. Although initial DMARD therapy or subcutaneous methotrexate may be very effective in some patients, other patients will need biologic therapy early, even at 8 weeks,” she said. “The problem is how to identify those patients.” Patients with early RA are hetero-

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Table 1 Remission as a Target: Use a Composite, a Single Measure, or Both? DAS28 (<2.6) and DAS28-CRP (<2.4) ACR/Boolean remission SDAI <3.3 Clinical Disease Activity Index <2.8 Computer-Assisted Management in Early Rheumatoid Arthritis (CAMERA) II: Swollen joints 0 + ≥2 of tender joints ≤3, Patient global assessment of disease severity ≤20 mm, Erythrocyte sedimentation rate ≤20 mm/h Zero swollen joints RAPID III <3 + ≤1 swollen joints SDAI + ultrasound remission ACR indicates American College of Rheumatology; CRP, C-reactive protein; DAS, Disease Activity Score; RAPID, Routine Assessment of Patient Index of Disease; SDAI, Simplified Disease Activity Index.

Table 2 Practice Recommendations American College of Rheumatology • Use tumor necrosis factor (TNF) inhibitors in patients with early rheumatoid arthritis, a poor prognosis, and a high Disease Activity Score (DAS) • Combine TNF inhibitors with methotrexate if high disease activity is present for 3-6 months, or <3 months if features of poor prognosis European League Against Rheumatism • Use TNF inhibitors after initial DMARDs fail and if with poor prognostic factors (ie, rheumatic fever, cyclic citrullinated peptide, high DAS, early erosion) Canadian Rheumatology Association • Trial of DMARDs targeting to remission; add biologics if low-dose aspirin is not achieved after 3 months of DMARD(s) used a full dose DMARDs indicates disease-modifying antirheumatic drugs.

geneous. The Canadian Early Arthritis Cohort (CATCH) study showed that 15% of patients with severe early RA are nonresponders, 30% are rapid good methotrexate responders (within 6 months), and 40% are slow methotrexate responders who require additional drugs (Sun L, et al. ACR, 2011. Abstract S957). Patients with low disease activity at baseline do not require much treatment to maintain that status, she noted. Studies have shown that patients who reach remission earlier with more intensive treatment have less radiographic joint damage. “If you aim for a target, use tight control, change therapy more often, you will optimize outcomes,” she emphasized. “Choose the target that will work for your patient.” Reasonable targets include remission, low disease activity, and no swollen joints. Remission criteria differ according to the target selected. For example, DAS28 remission allows swollen joints, while SDAI and Boolean remission criteria do not allow for swollen joints. About 12% of patients who achieve DAS28 <2.6 remission have 2 or more swollen joints. There are a number of targets, including

composite measures, single measures, and both (Table 1). “The more stringent criteria for remission, the less likely you will see swollen joints,” she said. “The best way to achieve drug-free remission is to treat early with intensive therapy.” Factors associated with the need to restart therapy after a target is achieved and lost include high DAS at baseline, steroid use, female sex, longer disease duration, and antibody-positive disease. Patients with the least amount of radiographic damage are more likely to remain in remission and responders have the best outcomes. Conversely, treatment failures have the most radiographic damage, Dr Bykerk continued. When to initiate biologic therapy is a critical issue. Current American College of Rheumatology guidelines state that tumor necrosis factor inhibitors should be initiated in patients with RA, a poor prognosis, and high DAS28 at baseline. The European League Against Rheumatism and Canadian guidelines state that if initial DMARDs fail, biologics should be started in patients with poor prognostic factors (Table 2). n VOL. 3

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Juvenile Idiopathic Arthritis

Updated JIA Recommendations Unveiled By Phoebe Starr

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ew recommendations for juvenile idiopathic arthritis (JIA) were published in 2013, updating the previous set of recommendations from 2011 (Ringold S, et al. Arthritis Care Res [Hoboken]. 2013;65:1551-1563). The recommendations encompass 3 common phenotypes of JIA and incorporate the following agents not included in the previous guidelines: canakinumab (Ilaris) and rilonacept (Arcalyst), both anti–interleukin (IL)-1 agents, and the anti–IL-6 agent tocilizumab (Actemra). “Systemic JIA is one of the most difficult categories of JIA to treat, and the updated recommendations now include first-line and second-line treatment recommendations for children with this disease,” said Sarah Ringold, MD, MS, Seattle Children’s Hospital and the University of Washington School of Medicine, Seattle. Dr Ringold and Pamela Weiss, MD, The Children’s Hospital of Philadelphia and University of Pennsylvania’s Perelman School of Medicine, Philadelphia, were coprincipal investigators for the 2013 treatment recommendations. Drs Ringold and Weiss and colleagues reviewed the literature to develop the new JIA recommendations using the RAND/UCLA Appropriateness Method to develop evidence-based recommendations by determining interventions that provide a

These recommendations provide guidance for healthcare professionals who treat JIA for appropriate initiation of therapeutic agents. —Pamela Weiss, MD, and colleagues health benefit exceeding that of health risk by a wide margin. The recommendations took about a year to develop and were voted on by an American College of Rheumatology task force panel of pediatric rheumatologists and researchers. The updated recommendations differ in several ways from the 2011 version: • The phenotypes are different • Previous risk stratification was not used

• Anakinra (Kineret), nonsteroidal anti-inflammatory drugs (NSAIDs), and systemic glucocorticoids are still recommended as initial therapeutic options for patients with active systemic features, based on slightly different disease activity parameters • Methotrexate/leflunomide are now an initial therapeutic option for systemic JIA without systemic features but active arthritis. Previously, all children had to have up to 1 month of NSAIDs plus or minus intra-arterial injection • Canakinumab and tocilizumab are now considered additional therapeutic options for continued disease activity. The new recommendations also incorporate repeat tuberculosis testing for all children with JIA and for children on biologics with an initial negative scan. Repeat testing can be undertaken at any point if the risk changes from moderate to high. Anakinra is now an option for firstline treatment of patients with active systemic features and synovitis, and patients with JIA and features of macrophage activation syndrome—a potentially fatal complication occurring in about 10% of JIA patients. Cana­ kinumab and tocilizumab are recommended as second-line options for patients with active systemic features and synovitis. Anakinra and tociliz­

at a glance ➤ Systemic JIA is very difficult to treat ➤ The updated recommendations include first-line and secondline treatment for children with the disease ➤ Validated disease activity scores are needed, as well as more data for recommendations, dosage, route, and tapering of glucocorticoids

umab are also recommended as options for second-line treatment for patients without active systemic features but with active synovitis. These recommendations provide guidance for healthcare professionals who treat JIA for appropriate initiation of therapeutic agents, and they are not intended to supplant individualized patient care, the investigators emphasized, because phenotypes and patient scenarios cannot encompass all possible presentations of JIA. The authors note that the updated guidelines have several limitations, including no validated disease activity score; low levels of evidence for many recommendations; and no specific dose, route, or tapering for glucocorticoid administration. n

Rheumatoid Arthritis

Depression Common in Patients with Rheumatoid Arthritis By Rosemary Frei, MSc

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lose to 17% of patients with rheumatoid arthritis (RA) may have depression, according to the results of a systematic review and meta-analysis (Matcham F, et al. Rheumatology. 2013 Sep 3. Epub ahead of print). This is significantly higher than the prevalence estimates provided by community-based studies, which usually are in the range of 5% or less, according to the investigators. The investigators also found that younger age in particular is associated with increased depression prevalence. They also discovered that a “bewil-

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“I think asking researchers to use standardized, validated thresholds to report depression is realistic and echoes the requests of various international guidelines provided to harmonize research findings.” —Faith Matcham, PhDc

dering diversity of assessment measures were used to ascertain depression,” the investigators wrote in the paper, and recommended that some homogeneity be brought to the field. “I set out to answer what I thought was a quite straightforward question: What is the prevalence of depression in RA? It soon became clear that depression is never straightforward, particularly the measurement of it,” said lead author Faith Matcham, who conducted the study as part of her psychological medicine PhD thesis under lead investigator Matthew Hotopf, PhD, at King’s College London april 2014

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in the United Kingdom. “I think asking researchers to use standardized, validated thresholds to report depression is realistic and echoes the requests of various international guidelines provided to harmonize research findings.” Ms Matcham conducted the literature review and meta-analysis under the auspices of IMPARTS (Integrating Mental and Physical Healthcare: Research, Training and Services), which, according to Ms Matcham, is an initiative seeking to improve mental healthcare provision in physical healthcare environments. Dr Hotopf Continued on page 16

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Interview

Access to Care Needed... and promoting resilience during difficult times. Other topics covered included rheumatology-related skin disorders, autoimmunity and rheumatologic manifestations of immune deficiency, inflammatory myopathy, psoriatic arthritis, and ankylosing spondylitis. Attendees included rheumatolo-

at a glance ➤ The North Carolina Rheumatology Association 2014 annual meeting covered a range of topics including rheumatology-related skin disorders and autoimmunity ➤ A challenge for a private practice such as Dr Shane’s is access to care ➤ Delays in ICD-10 may be beneficial, and allow rheumatologists to determine how to best implement it ➤ Providing effective, good quality care in a fiscally responsible manner is part of value-based care

Continued from page 1

gists, mid-level providers, and other healthcare stakeholders. What are the main challenges you are facing today? SA: The main challenges for me being a private practice rheumatologist with the particular patient demographic that I see in my clinic is access to care. We are very fortunate that in most of our autoimmune diseases to have really gained game-changing, life-changing, disease-modifying treatments, and it’s increasingly difficult to provide these treatments to patients. Simply due to access. Restriction to medicines either directly,

“The main challenge for me being in a private practice… is access to care.” —Shane Anderson, MD

excluding medicines from formularies, or making them cost prohibitive to patients. It makes it frustrating and challenging being a rheumatologist to know there are things that I can provide to the patient that will change

their life, but yet we cannot do that, and that is very frustrating.

“Sometimes it is easy to forget that practicing physicians are not only clinicians and researchers, but also small business owners.” How do you feel about the recent vote to delay ICD-10? SA: I think that it is important, and sometimes it is easy to forget that practicing physicians are not only clinicians and researchers, but also small business owners. Trying to implement large regulatory changes, “while helping your grandma with painful knees,” can be sometimes challenging, even with expert help from consultants. I think, that giving it another year to try and decide how best to implement this without it being a financial burden, without it being a regulatory burden upon practices such as my practice, I think is critical.

What does value-based care mean to you? SA: Value-based care means you are providing the best quality of care for the best reasonable expenditure healthcare dollars, as I suspect it means for most patients. Everyone practices with the understanding that everyone has a limited budget. There are expenditures to the things that we do, there are expenditures to patients and payers, and it is sometimes challenging to strike the balance providing effective, good quality care, but also doing it in a fiscally responsible way. And for me, that’s what’s value-based care means. n The mission of the North Carolina Rheumatology Association is to promote the science and practice of rheumatology, and advocate access to the highest quality healthcare and management of patients with rheumatic diseases. Their goal is to discuss, facilitate, and maintain scientific information regarding the practice of rheumatology care. For more information on the North Carolina Rheumatology Association, please visit their website at http://www. ncrheum.org/.

Rheumatoid Arthritis

Depression Common in Patients... is the principal investigator of IMPARTS. The first step in the analysis was to search medical literature databases for cross-sectional studies that included estimates of the prevalence of depression among adults with RA. They

at a glance ➤ Seventeen percent of patients with RA may have depression ➤ Homogeneity is needed when assessing depression in patients with RA ➤ Older patients with RA, who have had the disease longer, may be better adjusted psychologically than younger patients

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focused on 72 studies that included a total of 13,189 patients with a mean age of 53.7 years and a median of 77% women. The studies used 40 different methods to define depression. Seven studies used the Diagnostic and Statistical Manual of Mental Disorders (DSM) or the International Classification of Diseases, Ninth Revision diagnostic criteria to define depression and the other 65 used screening tools such as the Hospital Anxiety and Depression Scale and the Center for Epidemiologic Studies Depression Scale. The overall quality of the studies was poor; only 16.6% involved more than 300 patients. The prevalence of depression without psychological comorbidities ranged from 0.04% to 66.3% in the individual studies. The prevalence of major depressive disorder was 16.8% in those studies that used the DSM

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Continued from page 15

diagnostic criteria, while the prevalence of dysthymic disorder was 18.7%.

“There is…evidence to suggest that RA is more aggressive when it starts in younger people, so they may have more severe symptoms and require more aggressive medication.” —Faith Matcham, PhDc

“The 16.8% prevalence estimate is according to the ‘gold-standard’ method of detecting depression, through psychiatric interview follow-

ing DSM guidelines. Therefore, even with the most stringent criteria for defining depression, this estimate is still substantially higher than estimates provided in community studies, which tend to report depression prevalence of less than five percent,” noted Ms Matcham. “Increased disability at a younger age may impact more of life, for example having children, employability and socializing, compared to older people,” Ms Matcham observed. “There is also evidence to suggest that RA is more aggressive when it starts in younger people, so they may have more severe symptoms and require more aggressive medication, which can all impact well-being. Also, older patients with RA will have had the disease for longer, and therefore had more time to adjust to it psychologically.” n VOL. 3

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Autoimmune Diseases

HPV Vaccination Rates Dismal in Patients with Autoimmune Diseases By Phoebe Starr

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ptake of the Centers for Disease Control and Prevention– recommended human papilloma virus (HPV) vaccine is low in the general population, and a new study suggests that it is even lower among children and young adults with autoimmune diseases such as lupus, psoriatic arthritis, and inflammatory bowel disease. Since this group of children and young adults has a greater risk of infection than the general population, the findings of this study underscore the importance of public health efforts

at a glance ➤ This study underscores the importance of public health efforts aimed to increase acceptance of the vaccine ➤ 8.5% of people diagnosed with an autoimmune disease received at least 1 of the 3 recommended doses of the HPV vaccine compared with 9.1% of those without an autoimmune disease who received just 1 dose

aimed at increasing acceptance of the vaccine. “Our study demonstrated strikingly low uptake of the HPV vaccine among patients with and without autoimmune diseases. While increased [public health] efforts are necessary for the entire population, a particular focus should be those people with autoimmune diseases who are at high risk for persistent infection. Further studies are needed to better understand this low uptake and to develop strategies for improved access,” said lead author Candace Feldman, MD, rheumatology fellow at Brigham & Women’s Hospital, Boston, MA. Two different HPV vaccines are approved for men and women aged 9 to 26 years. The vaccine is safe and effective in patients with autoimmune diseases who are at increased risk of HPV infection, the most common cause of sexually transmitted diseases and cervical cancer. Improved access to the vaccine could prevent these diseases from occurring and be cost-saving. The study was based on a US commercial insurance claims database. Dr Feldman and coauthors retrospectively reviewed health records of 29,255 children with autoimmune diseases

and 117,020 without. The average age of the patients was 19 years and 59% were women. Patients with autoimmune diseases were age-, sex-, and date-of-diagnosis–matched with controls. The analysis of vaccine uptake was adjusted for patient characteristics, including comorbidities, healthcare received, and geographic region.

Although patients with autoimmune diseases saw their healthcare practitioners more often, the vaccine uptake was not higher. —Seoyoung Kim, MD

Dr Feldman and coauthors found that 8.5% of people diagnosed with an autoimmune disease received at least 1 of the 3 recommended doses of the HPV vaccine compared with 9.1% of those without an autoimmune disease who received just 1 dose (P = .034). Looking specifically at women, the investigators found that uptake rates for at least 1 of the 3 doses of vaccine

were 13.1% and 14.1%, respectively (P <.01). Less than 5% of both groups received all 3 doses of the vaccine. The highest rates of uptake were in 12-to 14-year-old girls; 35.5% of the patients had autoimmune diseases and 36.1% of the controls had at least 1 dose of the vaccine. Vaccine uptake was similar regardless of geographic distribution, with the exception of the Northeast where more people received at least 1 dose of the vaccine, according to the authors (P = .02). Patients with autoimmune diseases had significantly more physician visits, abnormal Pap smears, and sexually transmitted diseases compared with the group of patients without autoimmune diseases (P <.01). Senior author of the study, Seo­ young Kim, MD, Brigham & Women’s Hospital, commented at a press conference that even though patients with autoimmune diseases saw their healthcare practitioners more often, the vaccine uptake was not greater. “This suggests that physicians may not be offering these patients the vaccine. Maybe there are cultural, religious and other issues among families that influence uptake of the HPV vaccine,” she noted. n

Osteoporosis

Icelandic Company Streamlining Osteoporosis Management Decisions By Rosemary Frei, MSc

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o simplify the process of identifying patients who have osteoporosis or are at elevated risk of the common condition, a company has created the Osteoporosis Advisor. The tool, which is in use in Iceland and the Scandinavian countries, yields similar 10-year fracture risk values as FRAX (Fracture Risk Assessment Tool; World Health Organization). It also provides recommendations on treatment and lifestyle changes, as well as when patients should have their next dual-energy x-ray absorptiometry (DXA) assessment. “The incorporation of all of this information into a recommendation and

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a decision about whether or not to recommend to the patient that she have a bone mineral density scan can be a time-consuming task,” Thorsteinn Geirsson, Expeda’s Chief Operating Officer, told Value-Based Care in Rheumatology. “It is also predicated on considerable expert knowledge and experience, and therefore can involve the risk of medical errors. We wanted to standardize the process.” Bjorn R. Ludviksson, MD, PhD, and Bjorn Gudbjornsson, MD, Consultants with Expeda and Professors of Medicine at the University of Iceland, Reykjavik, together with 3 other rheumatologists used international clinical guidelines, including the World

Health Organization’s recommendations for 10-year fracture risk, and their own experience, to create a list of 17 patient attributes for the management of osteoporosis.

“The Osteoporosis Advisor is a handy tool for both clinicians and patients.” —Bjorn R. Ludviksson, MD, PhD

Drs Ludviksson and Gudbjornsson, and other Expeda collaborators used the Intellix Advisor to capture this inapril 2014

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formation in a procedure known as “knowledge mapping.” The investigators used data from a series of patients treated at the University of Iceland, and verified which attributes were central to understanding the most appropriate treatment approach for each patient. The Intellix Advisor produced a set of 10 parameters and 80 rules to determine the appropriate treatment and lifestyle recommendations for each patient. In addition, the team members also created an easyto-use interface that is web-based and can be used on personal computers, smartphones, and tablets. “It’s a handy tool for both clinicians and patients,” said Dr Ludviksson.

Continued on page 18

www.ValueBasedRheumatology.com

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Osteoarthritis

Better Dissemination and Implementation of Osteoarthritis Guidelines Needed By Alice Goodman

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ontemporary guidelines for the management of osteoarthritis (OA) from different stakeholder organizations are generally consistent, according to a systematic review of the literature undertaken as an initiative of the Chronic Osteoarthritis Management Initiative Work Group (Nelson AE, et al. Semin Arthritis Rheum. 2013 Dec 4. Epub ahead of print). But despite the existence of consistent guidelines across a number of medical societies and organizations, uptake and implementation of OA guidelines is suboptimal in the United States, Canada, and European countries, ranging from 22% to 57%. “Many of these recommendations from stakeholder organizations are generally agreed upon and could be readily implemented in clinical practice for a variety of specialties providing care to OA patients,” lead author Amanda E. Nelson, MD, MSCR, University of North Carolina, Chapel Hill, told Value-Based Care in Rheumatology. “The vast majority of care for OA occurs in primary care settings and efforts aimed at dissemination and implementation of these guidelines should be directed toward these providers for maximum impact.” Dissemination and implementation of guidelines is an important area that is now receiving much attention, according to the investigators. “No matter how important and clinically relevant research-based findings may be, it is only through dissemination and implementation that such guidelines

and/or research will reach the clinicians and patients who may benefit,” she added. Implementation of evidence-based guidelines will be tied to

“The vast majority of care for OA occurs in primary care settings and efforts aimed at dissemination and implementation of these guidelines should be directed toward these providers for maximum impact.” —Amanda E. Nelson, MD, MSCR

reimbursement, and may be used to create quality indicators and assess patient satisfaction. The present study was based on a MEDLINE literature search of articles published on OA guidelines from Jan-

uary 1, 2000, to April 1, 2013. Of 148 articles, 16 were eligible for inclusion and included in the final analysis. The articles comprised recommendations from the American College of Rheumatology, European League Against Rheumatism, American Association of Orthopedic Surgeons, Osteoarthritis Research Society International, as well as other societies. Fifteen of the 16 articles included recommendations that were in general agreement for nonpharmacologic management of OA: education and self-management; exercise and weight loss; assistive devices; alternative and complementary approaches; and surgical interventions. Education guidelines included patient referral to self-management, provide education, joint protection strategies and individualized plans for patients with OA. Exercise—including low-impact aerobic exercise and consideration of rangeof-motion exercises—and weight loss were recommended. Assistive devices such as walking aids were recommended as needed, but there was inconclusive evidence to support bracing or lateral heel wedges for knee OA and for splints for thumb-based OA. Six guidelines included surgical interventions. Guidelines that did recommend joint replacement for appropriate patients with hip or knee OA, stated that arthroscopy with debridement was not recommended for the management of symptomatic knee OA. Regarding pharmacologic management, the guidelines recommended acetaminophen/paracetamol as first-

at a glance ➤ Uptake and implementation of OA guidelines is suboptimal despite consistent guidelines across a number of medical societies and organizations ➤ Implementation of guidelines is an important area that is now receiving much attention ➤ Current guidelines regarding acupuncture, glucosamine/ chondroitin, and intra-articular hyaluronans are conflicting

line therapy for symptomatic OA, and second-line treatment with topical agents and oral nonsteroidal anti-inflammatory drugs, with appropriate risk stratification and gastroprotective strategies. Tramadol (Ultram) was recommended for refractory symptoms, and possibly opioids or duloxetine. Intra-articular corticosteroids were recommended for knee and hip OA, but there was insufficient evidence to make a general recommendation regarding intra-articular hyaluronans. Guidelines were conflicting regarding acupuncture, glucosamine/chondroitin, and intra-articular hyaluronans. “Dissemination and im­ ple­­ mentation efforts should focus not on controversial recommendations, but on those with universal agreement, such as those for education, exercise, and weight loss,” Dr Nelson and colleagues concluded. n

Osteoporosis

Icelandic Company Streamlining... To test whether the Osteoporosis Advisor provides accurate recommendations, the team built a set of 300 virtual quality control patients and found that the results were in agreement with real-life clinical information given for each case. The tool’s utility was verified using another set of patients from a hospital in Iceland. Ninety-four consecutive patients who received DXA scans in an outpatient osteoporosis clinic were selected; 45

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The Osteoporosis Advisor really increases the quality of life of the patient by providing detailed and practical information.

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patients received a recommendation from the Osteoporosis Advisor to have a DXA evaluation as soon as possible. After inputting the DXA measurements, the tool provided a recommendation for further investigation or treatment to 30 (67%) patients. General prevention measures were recommended for the remainder of the patients. They also found that there is a high correlation with the results of FRAX, and a significant con-

cordance with treatment recommendations from specialists. “The Osteoporosis Advisor really increases the quality of life of the patient by providing detailed and practical information about how to mitigate risk, and also enables healthcare practitioners to identify people who otherwise may remain undiagnosed. And it has been very well-received in the clinics and countries where it is in use,” said Mr Geirsson. n VOL. 3

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The Rheumatology Nurse

Mid-Level Providers Proficient in Rheumatology Practice By Rosemary Frei, MSc

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any nurse practitioners (NPs) and physician assistants (PAs) working in rheumatology clinics appear ready and willing to diagnose and treat rheumatoid arthritis (RA), according to a recently published survey (Solomon DH, et al. Arthritis Care Res [Hoboken]. 2013 Dec 10. Epub ahead of print). The results may pinpoint a key to preventing the projected shortfall in rheumatologists in the near future, the researchers suggest.

“We’re not going to be able train enough rheumatologists to fill that gap easily—and having midlevel providers like NPs and PAs getting rheumatology training in greater numbers is an obvious potential solution.” —Daniel H. Solomon, MD, PhD

“We’re not going to be able to train enough rheumatologists to fill that gap easily—and having mid-level providers like NPs and PAs getting rheumatology training in greater numbers is an obvious potential solution,” lead investigator Daniel H. Solomon, MD, PhD, and Chief of the Section of Clinical Sciences in Rheumatology, Brigham and Women’s Hospital, Boston, told Value-Based Care in Rheumatology. “They’re not a substitute but are an extender for doctors—our study confirmed they can manage a lot of clinical issues quite well.”

Dr Solomon and colleagues conducted the survey in anticipation of the predicted shortages in the rheumatologist workforce. In December 2013, investigators observed there is already a dearth of rheumatologists in many smaller regions of the country (American College of Rheumatology Committee on Rheumatology Training and Workforce Issues, et al. Arthritis Rheum. 2013;65:3017-3025). In addition, a recent proposal in the Affordable Care Act suggests more active roles for mid-level providers in team-based care (Iglehart JK. N Engl J Med. 2013;368:1935-1941). The last survey of mid-level rheumatology providers was published 6 years ago (Hooker RS, Rangan BV. J Clin Rheumatol. 2008;14:202-205). The investigators created a survey and worked with the Association of Rheumatology Health Professionals and the Society of Physician Assistants in Rheumatology to disseminate it electronically and by mail to mid-level providers working in rheumatology across the United States in 2012. The survey included 51 questions and took approximately 10 minutes to complete. Respondents received an incentive to participate. There was a 30% response rate; 174 NPs and PAs submitting completed questionnaires of 572 who received the survey. Overall, 82 NPs and 89 PAs responded to the survey (for a total of 171; 4 participants did not identify themselves as an NP or a PA and 1 identified herself as both). Approximately the same percentage practiced fewer than or more than 10 years as a mid-level provider, while 72.8% worked in rheumatology for no more than 10 years. The average age of the respondents was 46 years

and 84.2% were women. The respondents had a range of rheumatology training and duration of training. Overall, 69.5% of NPs and 58.4% of PAs said they had their own panel of patients. More than 75% reported being very confident in diagnosing patients with RA and 21.3% said they were somewhat confident. Similarly, 74.7% said they use RA disease measures such as the Disease Activity Score or the patient global arthritis activity index. Each NP and PA managed an average of 147 and 151 patients, respectively. Approximately half (47.6%) of the respondents said a rheumatologist assisted in patient visits when needed, while 38.6% said a rheumatologist rarely involved in patient visits. Very few respondents indicated that a rheuma-

Some rheumatologists say they would welcome mid-level providers and others say they would not. tologist was always or never involved in patient visits (5.4% and 8.4%, respectively). Mid-level providers’ level of independence was not statistically significantly related to their age, sex, certification as an NP or PA, number of years in rheumatology practice, or amount of rheumatology training. Almost all of the mid-level providers said they prescribed both nonbiologic and biologic disease-modifying antirheumatic drugs. The majority perform the entire spectrum of rheu-

at a glance ➤ NPs and PAs in rheumatology clinics appear willing to diagnose and treat RA ➤ Survey results show that 69.5% of NPs and 58.4% of PAs have their own panel of patients ➤ More than 75% of survey responders reported being very confident in diagnosing patients with RA ➤ Very few respondents indicated that a rheumatologist was “always” or “never” involved in patient visits

matology-related activities, including intake assessments, physical exams, interpreting bone density test results, giving intra-articular steroid injections, starting and adjusting medications, and patient education. Seventy-eight percent reported being familiar with treat-to-target strategies and 75.4% reported that the clinic they worked in used such strategies. Significant proportions of respondents reported managing infusion clinics (30.5%, NPs; 14.6%, PAs) and being involved in research (39.0% and 39.3%, respectively). “In addition to leading this survey I’ve also talked to many rheumatologists, and some say they would welcome mid-level providers and others say they wouldn’t,” noted Dr Solomon. “The trade-off is the volume of patients that can be seen—if the rheumatologist has no one to help with lower complexity visits it’s a less efficient use of his or her time.” n

FDA Update Apremilast Approved for Psoriatic Arthritis

The US Food and Drug Administration approved the use of apremilast (Otezla), a phosphodiesterase-4 inhibitor, on March 21, 2014, for the treatment of adults with active psoriatic arthritis. Most people develop psoriasis first and are later diagnosed with psoriatVOL. 3

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ic arthritis. Joint pain, stiffness and swelling are the main signs and symptoms of psoriatic arthritis. Three clinical trials (N = 1493) evaluated the safety and effectiveness of apremilast in this patient population. Patients treated with the drug showed improvements in signs and symptoms of psoriatic arthritis including tender and swollen joints, as well as physical

function compared with placebo. The FDA noted that patients treated with apremilast should have their weight monitored regularly by a healthcare professional. If unexplained or clinically significant weight loss occurs, the weight loss should be evaluated and discontinuation of treatment should be considered. Apremilast was also associated with april 2014

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an increase in depression compared with placebo. Common side effects observed in patients taking the drug were diarrhea, nausea, and headache. In addition, the US Food and Drug Administration is requiring a pregnancy exposure registry as a postmarketing requirement to assess the risks to pregnant women related to apremilast exposure. n

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CRA Meeting Highlights

Long-Term Safety of Rituximab... open-label prospective study were presented at the 2014 Canadian Rheumatology Association (CRA) annual meeting (Haraoui B, et al. Canadian Rheumatology Association's 2014 annual meeting, Whistler, BC, Feb 28Mar 1, 2014. Abstract Poster #1). Study Parameters Each rituximab course consisted of either two 500-mg or two 1000-mg intravenous (IV) infusions, 2 weeks apart. Every patient received IV methylprednisolone before 100 mg each rituximab infusion as well as concomitant methotrexate at a stable dose between 10 and 25 mg/week. Most patients also took acetaminophen and an antihistamine; oral corticosteroids and nonsteroidal anti-inflammatory drugs were also permitted. Overall, 3595 patients included in

at a glance ➤ Long-term analysis of patients with RA (n = 3595) for up to 11 years of follow-up suggests that rituximab is well tolerated over time ➤ The investigators found no new safety signals during the long-term exposure ➤ Use of biologics in patients with RA previously treated with rituximab was not associated with increased serious infectious events

the analysis received at least 1 rituximab infusion or a part of 1 infusion (ie, all-exposure group); 1246 patients received at least 1 rituximab infusion or part of 1 infusion and had at least 5 years of follow-up data (ie, long-term population group); and 818 patients received placebo (ie, placebo group).

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ous infectious events (SIEs) were lower respiratory tract infections, primarily pneumonia (2% of patients). SIE rates were 2.71/100 person-years (PY) in the long-term population, 3.76/100 PY in the rituximab all-exposure group, and 3.79/100 PY in the placebo group; these rates were stable over time and

“These long-term data from 3595 patients with up to 11 years of follow-up (14,816 PY [in total]) confirm that rituximab remains well-tolerated over time and multiple courses with a consistent safety profile.” —Boulos Haraoui, MD, and colleagues

The baseline characteristics were similar with the exception of the longterm population having a longer mean RA duration and a greater number of previous nonmethotrexate disease-modifying antirheumatic drugs compared with the other 2 groups. Positive Long-Term Findings Overall The investigators found that the rate of adverse events was highest in the first 6 months after first exposure to ri­ tuximab; this was partly because of infusion-related reactions, most of which occurred at the first infusion of the first course of rituximab treatment. RA exacerbations, pneumonia, osteoarthritis, and falls were each experienced by 2% of the patients taking rituximab. In addition, the most common seri-

over multiple treatment courses. There were no cases of hepatitis B reactivation, but there was 1 case of de novo hepatitis B infection in the all-exposure group. Two patients in the all-exposure group contracted pulmonary tuberculosis, the investigators reported. Biologic use after rituximab infusion was found not to increase the rate of SIEs. However, among the 224 patients who had <20 CD19+ cells/ μL before taking a biologic, the SIE rate was 5.03 events/100 PY. There were low immunoglobulin (Ig) levels in patients after rituximab treatment, particularly low IgM, but these were not associated with an increase in the rate of SIEs. Forty-six patients experienced a total of 56 myocardial infarctions, for

an overall rate of 0.39/100 PY; most of these patients had at least 1 risk factor for myocardial infarction, and the rate is “consistent with rates in the general RA population of 0.48-0.59 events/100 PY,” the investigators stated. The rate of confirmed serious malignancies was 0.74/100 PY. The investigators did not observe an increased malignancy risk over time or rituximab course. The rate is similar to rates in the general RA population, according to the investigators. The age- and sex-matched standardized incidence ratios of confirmed serious malignancies and breast cancer in the all-exposure population were 1.07 and 0.63, respectively, and were not higher than in the general or RA populations, the team concluded. Implications “These long-term data from 3595 patients with up to 11 years of follow-up (14,816 PY [in total]) confirm that rituximab remains well-tolerated over time and multiple courses with a consistent safety profile,” wrote lead author Boulos Haraoui, MD, head of the Clinical Research Unit in Rheumatology at the Centre Hospitalier de l’Université de Montréal, Ontario, and colleagues. “Apart from IRRs [infusion-related reactions] and low immunoglobulin concentrations, the overall safety profile of rituximab remains similar to that of the pooled placebo population and is consistent with published data for moderate to severe RA and with previous analyses of this patient cohort.” n

Low RA Disease Activity at 6 Months Associated with Remission at 12 Months By Rosemary Frei, MSc Whistler, BC—An observational study confirms in a real-world setting that people with rheumatoid arthritis (RA) who have low disease activity (LDA) after 6 months of biologic treatment are very likely to achieve remission within the next 6 months. An analysis of the Biological Treatment Registry Across Canada (BioTRAC) indicated that individuals who had LDA at 6 months had a probability between 33.3% and 59.8% of being in remission at 12 months. Conversely, patients not reaching

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“A rheumatologist can be quite confident in telling a patient in LDA status at 6 months that there is an excellent chance of maintaining their improvement at 12 months, and a good chance of improving further to a status of remission by continuing on their current therapy.” —Philip Baer, MD LDA at 6 months only had a 5.1% to 15.6% probability of remission at 1 year. The researchers presented the

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results at the 2014 Canadian Rheumatology Association Annual Meeting (Baer P, et al. Canadian Rheumatolo-

gy Association's 2014 annual meeting, Whistler, BC, Feb 28-Mar 1, 2014. Poster #69). These results mirror those from randomized controlled trials of various biologic agents in RA (Aletaha D, et al. Arthritis Rheum. 2007;56:3226-3235). “A rheumatologist can be quite confident in telling a patient in LDA status at 6 months that there is an excellent chance of maintaining their improvement at 12 months, and a good chance of improving further to a status of remission by continuing on their current Continued on page 21

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Lupus

Discontinuation of Immunosuppressants Safe in Patients with Lupus By Rosemary Frei, MSc Whistler, BC—A Toronto team has succeeded in completely tapering three-quarters of the patients with whom they attempted this discontinuation of immunosuppressants. Their analysis suggests immunosuppressant tapering is most likely to succeed in patients who are in clinical remission, who are on a low dose of corticosteroids, and who are tapered slowly. “You want to make sure the patient is clinically inactive—in remission— for at least a year and on no more than 7.5 mg per day of corticosteroids before you start tapering the im­muno­ suppressants,” explained lead investigator Zahi Touma, MD, PhD, after his team presented the results at the 2014 Canadian Rheumatology Association Annual Meeting (Touma Z, et al. Canadian Rheumatology Association's 2014 annual meeting, Whistler, BC, Feb 28-Mar 1, 2014. Poster #214). “And if you plan the immunosuppressant taper, it’s better to proceed slowly, because we found that patients who were tapered rapidly were 61% more likely to flare.” He also noted it is important to assess patients’ clinical status, lupus serological markers, and anti-DNA antibodies and complement levels at least every 3 months, to ensure they remain in remission. However, Dr Touma also said that some patients’ serological markers are not concordant with their lupus clinical status, somewhat complicating the process. “The main thing is you want to be sure that during the tapering of immunosuppressants, the patients’ serology isn’t

getting worse,” he told Value-Based Care in Rheumatology. “More importantly, that clinically there aren’t any signs of flare.” Immunosuppressants are used in patients with lupus to reduce disease activity and induce and maintain remission. In addition, they are used as steroid-sparing agents. However, they also have several drawbacks, pointed out Dr Touma, Assistant Professor of

“If you plan the immunosuppressant taper, it’s better to proceed slowly, because we found that patients who were tapered rapidly were 61% more likely to flare.” —Zahi Touma, MD, PhD

Medicine, Division of Rheumatology, University of Toronto Centre for Prognosis Studies in the Rheumatic Diseases. These include possible adverse events such as infections, gastrointestinal upset, cytopenias, amenorrhea, and alopecia, as well as an increased risk for hematologic malignancies. Therefore, Dr Touma’s team sought to determine whether immunosuppressant therapy can be stopped in patients who have achieved low disease activity or remission. They focused on the outcomes of the 179 patients in the Toronto lupus co-

hort who had immunosuppressant-tapering attempts. These patients were treated between 1970 and 2012, and had no activity in the Systemic Lupus Erythematosus Disease Activity Index 2000 clinical parameters, no proteinuria, thrombocytopenia, or leukopenia. They also were not taking >7.5 mg of prednisone daily. Ninety-one percent of the 179 patients were women with a total of 204 tapering attempts. Attempts were defined as at least a 25% reduction in immunosuppressant dose, with tapering not being done because of side effects. The patients’ mean age at the start of the attempts was 39 years and their average lupus duration was 11.2 years. Most (123) had been prescribed azathioprine, 42 were taking methotrexate, and 39 were on mycophenolate mofetil. There were 101 complete-tapering attempts and 76 (75%) were successful. These patients had a mean time to immunosuppressant discontinuation of 1.7 years and none experienced flares during a mean follow-up time of 1.6 years. The other 25 patients had a mean time to attempted discontinuation of 0.9 years. A clinical flare was defined as the start of, or any increase in, either an immunosuppressant or prednisone. The team calculated that there was an odds ratio of 1.61 for having a lupus flare among the patients tapered quickly versus those tapered more slowly. Furthermore, 47% of the 103 partial-tapering attempts succeeded, and these patients had no flares during a

Low RA Disease Activity at 6 Months... therapy,” explained lead investigator Philip Baer, MD, Chair, Ontario Medical Association Section on Rheumatology, Toronto, Ontario. “But if LDA hasn’t been reached at 6 months, it is unlikely that at 12 months the patient will be in remission. So it may be appropriate to consider a change in the therapeutic regimen at the 6-month mark if the treatment target for that patient is remission.” BioTRAC is an ongoing prospective registry funded by Janssen that tracks patients who are starting treatment for RA, ankylosing spondylitis, or psoriatic arthritis with infliximab or golimumab as first-line biologics, or after having VOL. 3

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been treated with another biologic for less than 6 months. The registry includes patients started on infliximab or golimumab as first-line therapy between 2002 and 2012. This analysis focused on the patients with RA and included only those 436 patients with at least 12 months of follow-up. The patients’ mean age was 56.1 years and their average disease duration was 10.4 years. The 4 scales used to determine LDA and remission were the Disease Activity Score (DAS)28 erythrocyte sedimentation rate (ESR), DAS28 C-reactive protein (CRP), Clinical Disease Activity Index (CDAI), and Simplified Disease

at a glance ➤ Tapering is most likely to succeed in patients who are in clinical remission, on a low dose of corticosteroids, and tapered slowly ➤ It is important to assess patients’ clinical status, lupus serological markers, and antiDNA antibodies and complement levels at least every 3 months, to ensure they remain in remission ➤ Further analysis of patient characteristics who completely discontinued immuno­ suppressants is needed to guide clinicians in selecting individuals who are the best candidates for successful tapering mean follow-up time of 2.1 years after the successful partial taper. The investigators defined partial tapering of immunosuppressants as a dose reduction but not complete discontinuation, due to either a flare during tapering or the patient still being tapered at their last clinic visit. Dr Touma told Value-Based Care in Rheumatology that he and his coinvestigators are now analyzing the characteristics of the patients who completely discontinued immunosuppressants, to further guide clinicians in selecting individuals who are the best candidates for successful tapering. n

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Activity Index (SDAI) scales. The remission rate at 12 months ranged from 15.9% to 16.5%, respectively, with the relatively strict CDAI/SDAI definitions, and 25.3% to 32.5%, respectively, with the broader DAS28 ESR and DAS28 CRP definitions. Furthermore, patients with an LDA at 6 months according to DAS28 ESR and DAS28 CRP had 53.4% and 59.8% probability, respectively, of being in remission at 12 months. The respective numbers for CDAI- and SDAI-defined LDA at 6 months and remission at 1 year were 33.3% and 37.8%. Those patients who did not reach LDA at 6 months had april 2014

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12-month remission rates that were significantly lower. Dr Baer’s team found in univariate analyses that the odds ratios of achieving remission at 1 year were always significantly elevated for those who had reached LDA at 6 months. These odds ratios ranged from 7.93 among patients with RA and a DAS28 ESR–based 6-month LDA to an odds ratio of 9.94 with an SDAI-based 6-month LDA. The investigators did not perform multivariate regression analyses “based on the advice of the study’s statisticians,” Dr Baer told Value-Based Care in Rheumatology.—RF n

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VBCR Perspective

The Role of Clinical Pathways... toxicity for each patient’s clinical situation, but instead, place emphasis on cost reduction as the overriding goal. They include: • Cost shifting: placing biologics in their own specialty pharmacy tiers with up to 20% to 30% higher copayments.3

“Payers are becoming more aggressive in deploying strategies to control the cost of care.” —Gary R. Feldman, MD

• Reduced reimbursements to providers: for in-office biologic therapies and administration. • Step therapies/medical necessity documentation: reducing access to therapies that are indicated, and for which multiple treatment choices exist. Rheumatologists have options

available to them that could change how coverage decisions are made. Clinical pathways are one of these options. They are tools used to guide care, and achieve clinical objectives that conform to clinicians’ priorities and also satisfy payers’ needs.4 In oncology practice—which has certain parallels to rheumatology—pathways have been developed and used in clinical practice that are physician-driven and use evidence-based medicine. The process of developing pathways is rigorous and requires thorough review of all available data. It places the greatest emphasis on efficacy, followed by toxicity, and only then, compares the cost of varying treatment approaches. Pathways are designed to achieve desired outcomes for the majority of patients and treatment scenarios. Ideally, they will conform to the 80/20 rule, which is generally accepted by payers. Eighty percent of patients with a given diagnosis will be successfully treated by the recommended therapeutic course, and 20% may have to go outside the pathway to achieve clinical goals. Pathways are also designed to be broad enough to give clinicians adequate choices for them to manage patients and narrow enough to better predict the cost of episodes of care. Using clinical pathways in the treatment of patients with multiple cancers has been shown to reduce the cost of care without compromising outcomes, and in some cases, has also been shown to reduce toxicity.5,6 De-

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spite this apparent success in oncology, it is not a given that this approach will be successful in rheumatology. We may undoubtedly need to alter the model of pathways to adapt to the differences between the treatment of patients with chronic autoimmune diseases vis-à-vis more episodic cancer therapies.

Whether rheumatologists are comfortable with it or not, cost-benefit analysis will play an increasing role in coverage decisions.

used to evaluate whether new agents will be cost-effective alternatives to branded biologics. Whether rheumatologists are comfortable with it or not, a cost-benefit analysis will play an increasing role in coverage decisions; this will affect the management of their patients. Clinical pathways may be a viable option to balance appropriate care with cost concerns in this era of health reform. For autoimmune diseases, this will take some degree of adaptation on the part of rheumatologists, but there is already a track record for the successful use of pathways in clinical oncology care.8 n References

The lack of consensus among rheumatologists on what metrics of activity and outcomes should be used in practice hampers the creation of pathways that can be widely accepted. Oncologists have had the opportunity to substitute a number of generic drugs into their regimens, which has generated significant cost-savings. Until biosimilars—agents considered “interchangeable” with US Food and Drug Administration–licensed biologics,7—come to market for rheumatologists to prescribe, the same potential for savings is not present in autoimmune diseases. There are currently limited data on head-to-head trials comparing biologic therapies, but as the approval process of biosimilars progresses, these data will increase significantly. These findings can be

1. Miller SB, Hoffman TA, Houts JC, et al. The rise of specialty pharmacy costs. Dis Manag Health Out. 2007;15:83-89. 2. The Express Scripts Research & New Solutions Lab. 2011 Drug Trend Report. Express Scripts. www. drugtrendreport.com/docs/DTR-2011.pdf. Published April 2012. Accessed March 17, 2014. 3. The Kaiser Family Foundation and Health Research & Education Trust. 2013 Employer Health Benefit Survey; Kaiser Family Foundation. http://kff.org/ private-insurance/report/2013-employer-healthbenefits/. Published August 20, 2013. Accessed March 17, 2014. 4. Kinsman L, Rotter T, James E, et al. What is a clinical pathway? Development of a definition to inform the debate. BMC Med. May 2010 [Epub ahead of print]. 5. Neubauer MA, Hoverman JR, Kolodziej M, et al. Cost-effectiveness of evidence-based treatment guidelines for the treatment of non-small-cell lung cancer in the community setting. J Oncol Pract. 2010;6:12-18. 6. Hoverman JR, Cartwright TH, Patt DA, et al. Pathways, outcomes and cost of colon cancer: retrospective in two distinct databases. J Oncol Pract. 2011;7(3 Suppl):52S-59S. 7. US Food and Drug Administration. Biosimilars. www.fda.gov/drugs/developmentapprovalprocess/ howdrugsaredevelopedandapproved/approvalappli cations/therapeuticbiologicapplications/biosimilars/ default.htm. Accessed March 25, 2014. 8. More evidence that clinically proven integrated cancer care enhances quality and controls cost. American Society of Clinical Oncology, Quality Care Symposium. November 30, 2012.

In the Literature Abatacept Biologically Active and Well Tolerated in Patients with Lupus Nephritis

Results from a 12-month, randomized, phase 2/3, multicenter, international, double-blind study showed evidence that abatacept was biologically active and well tolerated in patients with active class III and IV lupus nephritis. The primary end point, time to confirm complete response, was not met, the authors reported. Abatacept is currently approved for the treatment of patients with rheumatoid arthritis and juvenile arthritis. Three treatment groups of patients were randomized to receive abatacept 10 mg/kg (standard weight-tiered dose), abatacept 30 mg/ kg, or placebo for 3 months, followed

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by the standard weight-tiered dose (abatacept 30mg/10mg). Glomerular filtration rate, minimal proteinuria, and inactive urinary sediment during the 52-week treatment period were monitored. Overall, the authors found no difference between the treatment groups for the time to confirmed complete response or for the proportion of patients with confirmed complete response. Treatment with abatacept was associated with a greater improvement in anti–double-stranded DNA antibody, C3, and C4 levels from baseline. Compared with placebo, abatacept therapy led to a greater reduction (20% to 30%) in mean urinary protein-to-creatinine ratio in patients with nephrotic-range proteinuria (n = 122). In addition, treatment was well

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tolerated with rates of death, serious adverse events, and serious infections being similar among all arms (Furie R, et al. Arthritis Rheumatol. 2014;66(2): 379-389). B-Cells’ Activity Altered in Patients with Rheumatoid Arthritis Little research has been conducted in humans about regulatory IL-10 producing B cells (B10) in rheumatoid arthritis (RA), however, a recent study suggests that these cells are decreased in patients with RA. In addition, regulatory B10 cells were inversely correlated with disease activity. B cell subsets, including CD24hi CD38hi, CD24hi, CD27+, and CD5+ B cells, were evaluated in patients with RA and compared with healthy con-

trols. The investigators generated B10 cells from peripheral blood mononuclear cells; intra-cellular B cell IL-10 levels were assessed using cytometry. Among 99 patients with RA and 31 controls included in the study, levels of B cell subsets were found to be similar in both groups. However, levels of B10 cells were lower in patients with RA—especially in patients who had RA for less than 5 years, the investigators noted—compared with controls. “B cell ability to produce IL-10 was altered in RA and this impairment influenced disease activity, biological inflammation and auto-antibody levels,” the investigators concluded (Daien CI, et al. Arthritis Rheumatol. 2014 Apr 11 [Epub ahead of print]). n VOL. 3

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Health Policy

ICD-10 Delayed, SGR Patched for at Least 1 Year By Frederique H. Evans, MBS

A

s medical practices planned for International Classification of Diseases (ICD)-10 and the im-­ plementation of new diagnostic codes on October 1, 2014, practice administrators took steps to ensure that physicians and staff would be prepared. With the clock ticking down, staff had been signing up for training seminars, bringing experts onsite, and allowing extra coding time in the schedule, all to be sure that new codes would be entered accurately into patient claims beginning October 1. However, with a congressional vote in late March on bill H.R. 4302, Protecting Access to Medicare Act of 2014,1 and a sweep of the presidential pen, implementation of the new codes has been delayed for at least 1 year, caught up in legislation that also delayed cuts to physician reimbursements through Medicare’s sustainable growth rate (SGR) payment formula. While the legislative action avoided a nearly 24% reduction in physician payments through the SGR formula, many physician groups opposed this “patch,” instead favoring a reform of the Medicare reimbursement system.2 Since its deployment, 16 short-term annual fixes have been made to SGR to prevent payment cuts.3 “In the face of broad opposition from medical organizations against simply defaulting to another shortterm patch, the House relied on procedural maneuvering to quickly approve the 12-month proposal on a voice vote. The Senate followed suit…. Both chambers failed to seize a histor-

ic opportunity,” Ardis Dee Hoven, MD, President of the American Medical Association (AMA), said in a statement. “While we are disappointed that the fight for SGR repeal must continue, we are in a far better place to advance reform than we were a year ago. Rest assured that the AMA will continue to press for the changes we need to ensure our practices are sustainable and our patients have reliable access to the care they need.”4

“We are in a far better place to advance reform than we were a year ago.” —Ardis Dee Hoven, MD Earlier this year, a bipartisan group of House and Senate lawmakers proposed the SGR Repeal and Medicare Provider Payment Modernization Act,5 which intended to permanently repeal Medicare’s SGR formula for physician payments and replace it with annual increases of 0.5% between 2014 and 2018. These increases would be maintained through 2023 so that physicians have time to receive additional payments through a merit-based incentive payment system. The proposed act would apply to clinical nurse specialists, nurse practitioners, and physicians of medicine or osteopathy. In addition to the temporary SGR patch, the bill also extends the geographic practice cost index floor

through April 1, 2015, the therapy cap exceptions process through March 15, 2015, and increased inpatient hospital payment adjustment for certain low-volume hospitals starting on April 1, 2015, for FY2016 and subsequent tax years.1 The bill also extends the Medicare-dependent hospital program through March 31, 2015, and extends authority to renew a reasonable cost-reimbursement contract with a health maintenance organization and competitive medical plan through December 31, 2016. In addition, the bill amends the Medicare Improvements for Patients and Providers Act of 2008, to extend through March 31, 2015, the funding of various programs, including agencies on aging and the contract with the National Center for Benefits Outreach and Enrollment. It also authorizes the Secretary of Health & Human Services to continue through June 2015, with a specified limitation, certain medical review activities related to the 2 Midnight Rule. The latter is a controversial rule that allows Medicare coverage of only hospital stays for which a physician admits to a hospital a beneficiary expected to require care that crosses 2 midnights, but generally denies coverage of care expected to require less than a 2 midnight stay. The full list of amendments can be found on Congress.gov. What the Bill Means for You This extension, which the Con­ gressional Budget Office estimates will add as much as $180 billion to

the federal deficit,6 has left both lawmakers and healthcare professionals alike with many unanswered questions.7 In particular, the Cen­ters for Medicare & Medicaid Services wonders whether October 1, 2015, will become the new deadline; whether the agency will allow organizations that are ready to implement ICD-10 to do so voluntarily; and whether the agency will scrap ICD-10 altogether, and instead wait for ICD-11 , which is due to be released in 2017. n References

1. Congress.gov. H.R. 4302 – Protecting Access to Medi­care Act of 2014. http://beta.congress.gov/bill/ 113th-congress/house-bill/4302. Accessed April 9, 2014. 2. Pittman D. SGR, ICD-10 Delay Ready to Be Signed Into Law. MedPage Today. http://www.medpage today.com/PublicHealthPolicy/Medicare/45043. Published March 31, 2014. Accessed April 14, 2014. 3. MacDonald I. Senate Oks SRG patch, delays ICD-10. Fierce Healthcare. http://www.fierce healthcare.com/ story/senate-oks-sgr-patch-delays-icd-10/2014-03-31. Published March 31, 2014. Accessed April 10, 2014. 4. AMA Wire. Why permanent SGR repeal lost to another temporary payment patch. http://www.amaassn.org/ama/pub/ama-wire/ama-wire.page?plck Control ler=Blog&plckBlog Page=BlogViewPost& UID=e38cf47a-fc5f-473b-9234-c9e714c1c8f0&plckPos tId=Blog%3ae38cf47a-fc5f-473b-9234-c9e714c1c8f 0Post%3aaf492466-72dd-449d-a053-8720eacadb3f& plckScript=blogScript&plckElementId=blog Dest#. U0wBUPldV40. Published April 1, 2014. Accessed April 14, 2014. 5. Lawmakers announce bipartisan deal to repeal, replace SGR. www.californiahealthline.org/articles/ 2014/2/7/lawmakers-announce-bipartisan-deal-torepeal-replace-sgr. Published February 7, 2014. Accessed April 10, 2014. 6. The United States Senate Committee on Finance. Hatch calls for return to bipartisan, bicameral talks to advance bill to permanently fix broken SGR formula. http://www.finance.senate.gov/newsroom/ ranking/release/?id=38523414-4dd3-478e-945a-111ecc1ca5bf. Published March 31, 2014. Accessed April 10, 2014. 7. Carlson J, Robeneznieks A. ICD-10 delay puts pressure on CMS for answers. Modern Healthcare. www.modernhealthcare.com/article/20140401/ NEWS/304019940/icd-10-delay-puts-pressure-oncms-for-answers. Published April 1, 2014. Accessed April 10, 2014.

7.1 Million Enrolled by March 31 Deadline AMA Offers Physician Resources, Works to Ease Transition By Rosemary Frei, MSc

A

s the clocked ticked down to midnight on March 31, many Americans rushed to enroll in health in­ surance plans made available to them through the Afford­able Care Act (ACA). Ap­proxi­mately 4.2 million people had selected a Market-place plan as of March 1, 2014, less than half of the 8.8 million who have been deemed eligible,1 and 60% of the 7 million people the Congress­ ional Budget Office projected for this timeframe.2 But in the 30 days from March 1 until the end of open enrollment, nearly 3 million people signed up for government-run health insurVOL. 3

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ance plans, bringing the total number enrolled to 7.1 million, according to an announcement from President Barack Obama outside the White House on April 1.3 A Law That Is “Helping Millions” Citing other statistics, the President also noted that 3 million young adults have gained health insurance by staying on their parents’ plans, and millions more have been insured through the expansion of Medicaid and children’s health insurance programs. The ACA allows children younger than 26 years of age to remain on their

parents’ insurance plans. “This law is helping millions of Americans,” the President said at the April 1 press conference, “and in the coming years it will help millions more.” He acknowledged that while the ACA has allowed millions of Americans to purchase insurance, it does not mean that “all the problems of healthcare have been solved forever,” citing rising private insurance premiums and the millions of Americans who still remain uninsured.3 In addition to those concerns expressed by the President, mainstream media has also explored concerns reapril 2014

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garding the ACA, including the impact narrow networks could have on patients with cancer or survivors whose care may not be covered under their purchased plan. For physicians and practice administrators, confusion regarding their inclusion in (or exclusion from) insurance plans’ network panels, questions about reimbursement, and uncertainty regarding the law’s 90-day grace period are lingering. From the AMA Ardis D. Hoven, MD, president of the American Medical Association Continued on page 24

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Health Economics

Costs of Biologic Drugs Outweigh Reductions... lines in Sweden, as in the United States, the final selection of treatment for a patient with RA is made by the treating physician, explained lead author Almina Kalkan, PhDc, Linköping University, Linköping, Sweden.

“Our study shows that the costs of RA have increased, despite lowered use of healthcare and sick leave/ disability pension by RA patients.” —Almina Kalkan, PhDc

“Our study shows that the costs of RA have increased, despite lowered use of healthcare and sick leave/disability pension by RA patients,” she told Value-Based Care in Rheumatology. “The amount of indirect costs has decreased and direct costs have increased. This implies that the costs to

the societal insurance system for this disease have increased relative to the costs to the healthcare system.” “We purposefully chose 10 years before and 10 years after the introduction of biologics for our study that retrospectively measures on a national level, with all data available, how the indirect costs have changed,” she continued. “One needs to ask whether these increased costs [of biologics] are accompanied by large increases in quality-of-life.” Although studies show trends toward large initial quality-of-life benefits for biologics versus traditional triple therapy with disease-modifying antirheumatic drugs (DMARDs), in the longer term, there is little if any difference in quality of life between the treatments. Targets of treatment in RA, including remission/low disease activity and improved functional status, can be achieved with both expensive and less expensive antirheumatic drugs, she stated, citing recent research (Sokka T, et al. Clin Exp Rheumatol. 2013;31:409-414). “Because of the large initial benefit with biologics, some physicians may increasingly choose to skip the phase with triple therapy but jump directly to biologics,” she said.

Costs and Benefits of Treatment Using comprehensive national data­ bases for the study, the investigators analyzed both current and fixed prices. Fixed prices were adjusted for inflation using the Consumer Price Index and a healthcare price index reflecting changes.

“The benefits of biologic treatment should be weighed against the considerable costs of biologic drugs compared with traditional DMARDs.” —Almina Kalkan, PhDc, and colleagues The direct costs included inpatient and outpatient care, as well as cost of drugs. Indirect costs included sick leave due to RA and disability pensions for patients with RA. Throughout the study period, utilization of inpatient care for RA decreased, with a more pronounced decline between 1994 and 2000, than after 2000. Outpatient care for RA remained relatively

Continued from page 1

at a glance ➤ RA treatment selection is made by the treating physician ➤ Treatment costs associated with RA, including hospitalization, have not been reduced enough to offset the costs of more expensive drugs

unchanged during the study period. The number of days of sick leave due to RA decreased by 50% after the mid-1990s, while newly granted disability pensions due to RA fluctuated, closely mirroring the pattern for the populations with other diagnoses. The fixed costs of RA doubled between 1990 and 2010. These price increases largely outweighed any reductions in other costs. Total fixed costs increased by 32% over the study period. Inflation adjustments showed a noticeable downturn in all costs except drug costs. “The benefits of biologic treatment should be weighed against the considerable costs of biologic drugs compared with traditional DMARDs,” according to Ms Kalkan and colleagues. n

Health Policy

7.1 Million Enrolled by March 31 Deadline... (AMA), noted the organization’s efforts and was optimistic in a recent interview that the ACA would help ensure that every American has access to affordable, quality healthcare. Her organization has been working for years with the federal government to make improvements to the ACA and ease the transition, she said. “As the ACA was implemented, AMA provided fact sheets and toolkits to inform both patients and physicians about aspects of the new law,” Dr Hoven stated. “We will also monitor physician and patient experiences closely so we can accurately identify problems and advocate for solutions.” She noted in an AMA View­points article in February that “in these first months of Affordable Care Act implementation, there’s a lot of uncertainty around health plans sold through the insurance exchanges and how their

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lack of transparency will impact continuity of patient care.”4

“We encourage physicians to keep the AMA and federal government informed as implementation of the law continues.” —Ardis D. Hoven, MD

“To help physicians through the transition in their practices, we are providing practical resources, including a six-step checklist we just released with

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the Medical Group Management Association and forthcoming resources related to managing care through a patient’s 90-day grace period,” she said.4,5 The checklist points are: • Double check whether your practice’s physicians are participating with ACA exchange products; • Determine your practice’s ability to accept new patients; • Train office staff who speak with callers and patients so they can readily answer questions on insurance and enrollment; • As with other insurance, check patient eligibility, coinsurance, de­ductibles, and copays for each visit; • Be prepared to discuss out-ofpocket expenses and the cost of care with each patient; and, • Know the essential health benefits in your state.

Continued from page 23 In addition, Dr Hoven noted that the AMA is working with state governments on a transparency campaign6 that includes model bills7 on tiered and narrow networks (to provide meaningful access to accurate physician directories, institute due process and physician-profiling protections, and honor patients’ benefits assignments), informing physicians if one of their patients is in a 90-day grace period for nonpayment of premiums, and preventing insurers from forcing doctors to participate in all of the insurers’ networks if they agree to be a part of one of their plans. The AMA has a list of documents written by its officials between 2010 and April 2013 on the ACA implementation regulations.8 The most comprehensive statement was posted in October 2011, noting, “The new law includes many major provisions VOL. 3

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Rheumatology Update

Automatic Prediction of RA Disease Activity from EMR Becoming a Reality By Rosemary Frei, MSc Washington, DC—Researchers have customized a software suite to automatically determine the disease severity in patients with rheumatoid arthritis (RA) based on information from their electronic medical records (EMRs). This is a solid first step toward streamlining and individualizing diagnosis and treatment of this condition, according to the investigators. “The system we created will be used by our rheumatologist collaborators to correlate drug response, as measured by change in disease activity, with genotyping studies for the purpose of individualized medicine,” said Chen Lin, MA, a member of the Natural Language Processing Lab of Boston Children’s Hospital Informatics Program, after presenting information on the project. The work was funded by the National Institutes of Health through the Pharmacogenomics Research Network (PGRN) and also was published in PLoS One (Lin C, et al. 2013; 8(8):e69932). Mr Lin and colleagues, including Timothy Miller, PhD, Guergana Savova, PhD, and Brigham and Women’s Hospital rheumatologist Elizabeth Karlson, MD, used the Apache clinical Text

Analysis and Knowledge Extraction System (cTAKES) as the framework for their project. The open-source software uses natural language processing methods to extract the information from EMRs. The challenge the team sought to address was that physicians often do not code disease activity in structured fields in patients’ EMRs, opting instead to write it in the clinical narrative. In addition, laboratory values are not measured at every visit, observed Mr Lin. That makes it difficult to produce an accurate automated report on each patient’s disease status. To surmount these challenges, the researchers used “automatic feature development” to program cTAKES to filter out all non relevant information in the written clinical notes from the EMRs, thereby boosting the underlying algorithm’s accuracy and efficiency. They also assigned 1 code for all terms used to describe RA in the notes; as a result, ‘rheumatoid arthritis,’ ‘Rheumatoid Arthritis,’ ‘ARTHRITIS RHEUMATOID,’ and ‘RA’ all were assumed by the program to be RA. Another innovative approach employed by the team was to “train” the

program to use information from structured disease activity assessment 28 (DAS28) scores, based on C-reactive protein and/or erythrocyte sedimentation rate levels, to classify each pa-

“The system we created will be used by our rheumatologist collaborators to correlate drug response, as measured by change in disease activity, with genotyping studies for the purpose of individualized medicine.” —Chen Lin, MA tient’s disease activity as being either low/remission or moderate/high. To do this, they ran data through the program from 2792 notes in the EMRs of 852 patients who had participated in the Brigham and Women’s Hospital Rheumatoid Arthritis Sequential Study (Iannaccone CK, et al. Rheumatology. 2011;50:40-46).

After the resulting fine-tuning, the team next tested the program on a set of 1749 notes from another 821 patients’ visits to rheumatology clinics at Brigham and Women’s Hospital. This time, the disease-activity label of each note was derived from not only the DAS28 scores but also the patients’ assessment of activity and the treating physicians’ estimation of the number of swollen and tender joints. The resulting accuracy of the program’s determination of patients’ disease activity was 78.9% as measured by the F1 score. In the third and final step of testing, the researchers had the program analyze information from 344 randomly selected notes that lacked laboratory values from another 344 RA patients’ EMRs. Three rheumatologists separately reviewed all of the notes and made determinations of patients’ disease activity. The overall accuracy of the algorithm was 83.1%. The largest proportion of the program’s disease activity misclassifications compared with the rheumatologists’ determinations were in the moderate and low disease activity categories, accounting for 20% and 62% of the total errors, respectively. n

Health Policy that are consistent with AMA policy and hold the potential for a stronger, better-performing healthcare system. While the new law represents a tremendous step forward on the path toward meaningful health system reform, it is not the last step, but rather the beginning.”9 The AMA generally supports many major provisions in the ACA, including increased access to health insurance and the undertaking of comparative effectiveness research. It also advocates for changes to the ACA, such as postponing penalties related to quality-reporting data and eliminating a Medicare/Medicaid enrollment fee for physicians.9 The organization is also working to modify or alter some measures. These include delaying implementation of the value-based payment modifier, modification of requirements for referring physicians to tell patients when they are referring the patients to a hospital that they own or are an inVOL. 3

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vestor in, and ensuring strategic advancement of electronic health information exchange and interoperability (ie, working toward a smooth exchange of healthcare information between healthcare providers and health insurance providers).10 The AMA’s Board of Trustees voted unanimously to adopt policies crafted at the 2013 annual meeting of the organization’s House of Delegates, which sought to improve the ACA and healthcare, including a call to repeal the nonphysician–provider nondiscrimination provisions of the ACA. In addition, in early March, the AMA issued a letter to the Centers for Medicare & Medicaid Services (CMS) asking that the organization revisit the policy that allows insurers to deny or pend claims for the second and third months of the 90-day grace period. The AMA also asked that CMS require insurers to notify physicians as soon as a patient has entered the grace period for nonpayment of premiums. In addition

to the AMA, 85 organizations signed the letter.11 “We encourage physicians to keep the AMA and federal government informed as implementation of the law continues,” said Dr Hoven. Physicians can send an e-mail to exchangeplans@ ama-assn.org if they identify any systemic issues that have not yet been addressed. n References

1. Kaiser Family Foundation. State marketplace statistics. http://kff.org/health-reform/state-indica tor/state-marketplace-statistics-2/. Accessed April 9, 2014. 2. Centers for Medicare & Medicaid Services; US Department of Health and Human Services. Projected monthly enrollment targets for health insurance marketplaces in 2014—information. Memo. September 5, 2013. http://waysandmeans.house.gov/uploadedfiles/enrolltargets_09052013_.pdf. Accessed April 9, 2014. 3. Shear MD, Pear R. Obama claims victory in push for insurance. April 1, 2014. www.nytimes. com/2014/04/02/us/politics/obama-to-report-onprogress-of-health-care-law.html?_r=0. Accessed April 9, 2014. 4. Hoven AD. ACA roll-out may have its bumps, but we’re working toward a stronger future. AMA Viewpoints. February 4, 2014. www.ama-assn.org/ ama/pub/ama-wire/ama-wire.page?plckControl ler=Blog&plckBlogPage=BlogViewPost&UID=e38c f47a-fc5f-473b-9234-c9e714c1c8f0&plckPos

april 2014

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tId=Blog%3ae38cf47a-fc5f-473b-9234-c9e714c 1c8f0Post%3ae46896e6-c192-4b83-a348-e91932a beaf0&plckScript=blogScript&plckElementId=blog Dest#.Uwy4UrmPJD9. Accessed April 9, 2014. 5. American Medical Association, Medical Group Management Association. Medical practice checklist for 2014 ACA exchange implementation. www. ama-assn.org/resources/doc/washington/aca_ checklist.pdf. Accessed April 10, 2014. 6. American Medical Association Advocacy Resource Center. Health insurance exchanges state implementation transparency campaign. www.ama-assn.org/ resources/doc/arc/hix-transparency-summary.pdf. Accessed April 10, 2014. 7. State implementation of the Affordable Care Act. www.ama-assn.org/ama/pub/advocacy/state-advoca cy-arc/state-advocacy-campaigns/state-health-reform/ state-im plementation-aca.page. Accessed April 10, 2014. 8. AMA comments on ACA implementation regulations. www.ama-assn.org/ama/pub/advocacy/top ics/affordable-care-act/ama-comments-on-aca-regula tions.page. Accessed April 10, 2014. 9. Advocating for improvements to the Affordable Care Act. www.ama-assn.org/ama1/pub/uploadmm/399/ aca-advocating-for-improvements.pdf. Accessed April 10, 2014. 10. American Medical Association. Re: advancing interoperability and health information exchange [CMS–0038–NC]. Health information exchanges comment letter. April 22, 2013. www.ama-assn.org/ resources/doc/washington/health-information-ex changes-comment-letter-22april2013.pdf. Accessed April 10, 2014. 11. American Medical Association; Medical Group Management Association; American Academy of Child and Adolescent Psychiatry, et al. Re: concerns regarding 90-day grace period in ACA-subsidized exchange health insurance. Letter. March 5, 2014. www.ama-assn.org/resources/doc/washington/ aca-grace-period-sign-on-05march2014.pdf. Accessed April 10, 2014.

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Psoriatic Arthritis

Anti–TNF-alpha Plus Corticosteroids Linked to Infections By Frederique H. Evans, MBS

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nfections may be associated with comorbidity and mortality in patients with psoriatic arthritis (PA) and ankylosing spondylitis (AS; spondyloarthropathy [SpA]), and rheumatoid arthritis (RA). Results from a retrospective observational study suggest that anti–tumor necrosis factor; (TNF)-alpha and corticosteroids (CS) combination promote infection; disease-modifying antirheumatic drugs (DMARDs) were found to be relatively safe (Germano V, et al. J Transl Med. 2014;12:77). “Physicians, therefore, should be aware that there may be an increased risk of infection when using anti– TNF-alpha and CS therapy together,” Valentina Germano, Department of Clinical and Molecular Medicine, Sapienza University of Rome, Italy, and colleagues stated. Although CSs may delay radiographic joint damage, the authors added, they should be carefully used with biologics. The impact of DMARDs, CSs, and 3 TNF-alpha antagonists licensed in Italy was evaluated, in monotherapy

and combination therapy, among patients with RA and SpA. In particular, they looked at incidence rates per 100 patient-years and stratified the patients according to therapy. All RA and SpA outpatients who visited the Immuno-rheumatology Division of the S. Andrea University in Rome between November 2003 and December 2009 were included. The 1987 American College of Rheumatology guidelines were used to diagnose patients with RA; Moll and Wright criteria were used for patients with PA; and the modified New York criteria were used for AS. Patients were followed in 3 month intervals, and stratified based on therapy: DMARDs alone, DMARDs plus CS, anti-TNF-alpha alone, anti– TNF-alpha plus CS, anti–TNF-alpha plus DMARDs, and anti–TNF-alpha plus DMARDs and CSs. Overall, 341 patients with a total of 911.8 patient-years of follow-up, and a median of 26.04 months of follow-up were included in the analysis. Fiftytwo percent (n = 176) of the patients had at least 1 infection. Infection rates

were 3.8 per 100 patient-months in the first 6 months of treatment. In particular, the investigators found that women had a statistically significant

“Physicians should be aware that there may be an increased risk of infection when using anti–TNF-alpha and CS therapy together.” —Valentina Germano, and colleagues

increased risk of infection compared with men. In addition, they found that the rate of infection tended to decrease with increased age-groups; the association was not statistically significant, they noted. Infection rates between RA and SpA were similar. Disease activity

was also associated with infection rates, with moderate and severe disease activity linked to increased rate of infection. In addition, the investigators observed that vaccination against influenza and the absence of comorbidities tended to reduce infection rates; this association was not statistically significant. The respiratory tract was the most frequent site of infection, and bacteria was associated with three-quarters of all infections. In addition, multivariate analysis demonstrated that adding anti-TNF-alpha to DMARDs doubled the infection incidence rate ratios compared with DMARDs alone, anti– TNF-alpha plus CSs tripled it, and anti–TNF-alpha plus CSs plus DMARDs increased the risk 2.5 times. “The search for personalized treatment options should be driven by these considerations, trying to maintain with DMARDs the remission phases induced by biologics, as indicated by EULAR [European League Against Rheumatism],” the investigators concluded. n

Rheumatology Update

A Closer Look at Costs Incurred by Patients with RA

T

reatment for a life long condition such as rheumatoid arthritis (RA) is a significant part of the costs incurred by patients, but costs such as travel time and associated expenditures are also substantial costs incurred by these patients. To evaluate the impact of social costs associated with RA, investigators sought to determine the frequency of contacts with different types of healthcare providers and assess the

at a glance ➤ How to include travel time and costs associated with RA in a complete analysis of social costs is not clear ➤ Variations in travel time and expense were not significantly associated with patient population groups or disease characteristics

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average travel time and costs during a 3-month period using a self-complete questionnaire in a group of Danish outpatients with RA (Sørensen J, et al. Int J Rheumatol. 2014 Feb 17. Epub ahead of print). “Patients’ time and costs during illness and healthcare treatment are relevant aspects to include in a complete analysis of the social costs of health interventions,” according to Jan Sørensen, Centre for Applied Health Services Research, University of Southern Denmark, Odense, and colleagues. “While the need to include travel time and costs is widely accepted, details about how travel time and costs should be included have not been resolved.” Overall, data from 2847 patients with RA from 11 outpatient clinics across Denmark were collected. The investigators evaluated various measures, including frequency, travel time, and travel costs for contacts at rheumatology outpatient clinics, other outpatient clinics, as well as general practitioners, privately practicing

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“Patients’ time and costs during illness and healthcare treatment are relevant aspects to include in a complete analysis of the social costs.” —Jan Sørensen

medical specialists, inpatient hospitals, and accident and emergency departments. Over the course of 3 months, patients with RA had an average of 4.4 contacts with healthcare providers; 2.8 contacts were with rheumatology outpatient clinics. In addition, patients spent an average of 63 minutes and 13€ traveling per contact, or 4.6 hours and 56€ during the course of the study. Variations in patient travel time and costs were found, but no statistically significant associations were

observed related to clinical and sociodemographic characteristics, the investigators noted. Dr Sørensen and colleagues noted that the social costs incurred by patients with RA were not surprising. However, they had expected greater variation in travel time and expense between different patient population groups and disease characteristics. In particular, patients with RA living in larger cities, with elevated C-reactive protein levels, and on biologic treatment, had more contacts and spent more time and expense on travel than other patients. The association was not statistically significant. “These variables were unable to explain much of the observed variation in travel time, and costs,” the investigators noted. Overall, the results indicate that patients with RA spend private time and costs on traveling when they are getting treatment, investigators concluded. This should be taken into consideration when analyzing social costs associated with the disease.—FE n VOL. 3

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Join Our Editorial Advisory Board Value-Based Care in RheumatologyTM is looking for practicing rheumatologists with a wide range of experience who are interested in joining our Editorial Advisory Board. Now in its second year of publication, Value-Based Care in RheumatologyTM covers key developments from rheumatology literature and from national and interna足 tional rheumatology meetings. Editorial Advisory Board members provide expert commentaries and perspectives on value-based care in all rheumatic diseases and offer expert opinion on relevant topics and new developments in the field, including new and emerging drug therapies, managing patients with rheumatic diseases, practice management, as well as payers and policy issues affecting rheumatology practices.

Mission Statement Value-Based Care in RheumatologyTM provides a forum for payers, providers, and the entire rheumatology team to consider the cost-value issues particular to rheumatology treatments. This unique focus is achieved through news coverage from major rheumatology meetings and the rheumatic diseases literature, supplemented with commentaries and perspectives from those involved in evaluating therapies, treating patients, and paying for care.

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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

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