The SARAH Study: A Trial
and Economic Evaluation of Exercise for Rheumatoid Arthritis of the Hand
VOLUME 3 • NUMBER 1
Topical Treatment of Osteoarthritis Shelly Kafka, MD, and Wesley A. Kafka, PharmD candidate
steoarthritis (OA) is the most have osteoarthritis.2 There are numercommon form of arthritis. ous studies documenting lost wages and Currently, 27 million people limitations of both paid work and social in the United States have OA, and the activities due to OA.2 numbers are expected to rise significantThe American College of Rheumatol ly with an aging population. Two-thirds ogy has established treatment guidelines of the population that receive a doctor’s for OA, the most recent of which were 1 diagnosis will be women. By the age published 2012.3 PRACTITIONERS The emphasis of FOR OFFICE ADMINISTRATORS, RHEUMATOLOGISTS, PHYSICIAN ASSISTANTS, ANDin NURSE of 85 years, nearly 1 in 2 patients will treatment depends on the site involved Continued on page 8
t has not been established that exercise improves hand and wrist function in people with rheumatoid arthritis (RA). The study Strengthening and Stretching for Rheumatoid Arthritis of the Hand (SARAH) evaluated the clinical efficacy and cost-effectiveness of exercise Continued on page 7
Cautious Stance Taken by American College of Rheumatology’s Position Statement on Biosimilars Rosemary Frei, MSc
he American College of Rheumatology (ACR) has released an official position statement on biosimilars,1 on the heels of
the first biosimilar approval by the US Food and Drug Administration (FDA). Filgrastim-sndz (Zarxio, Sandoz) was approved on March 6, 2015.2 Continued on page 6
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Biosimilar Infliximab Entering Use in 12 European Countries........................................................................................................ 5
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Haplotypes Associated With RA Severity, Mortality, FOR OFFICE ADMINISTRATORS, RHEUMATOLOGISTS, PHYSICIAN ASSISTANTS, AND NURSE PRACTITIONERS and Treatment Response........................................................................... 7
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NORM Celebrates 10 Years..................................................................... 10
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SGR Repealed, But the Work Is Just Beginning.................................. 11 Gail Thompson
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Rheumatology healthcare requires providers to focus attention on financial concerns and strategic decisions that affect the bottom line. To continue to provide the high-quality care patients deserve, providers must master the ever-changing business of rheumatology. Rheumatology Practice Management offers process solutions for members of the rheumatology care team—physicians, nurses, and auxiliary clinical staff, as well as executives, administrators, and coders/billers—to assist them in reimbursement, staffing, electronic health records, REMS, and compliance with state and federal regulations.
Rheumatology Practice Management™, ISSN 2164-4403 (print), is published 5 times a year by Engage Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Copyright © 2015 by Engage Healthcare Communications, LLC. All rights reserved. Rheumatology Practice Management™ is a registered trademark of Engage Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the publisher. Printed in the United States of America. The ideas and opinions expressed in Rheumatology Practice Management™ do not necessarily reflect those of the editorial board, the editors, or the publisher. Publication of an advertisement or other product mentioned in Rheumatology Practice Management ™ should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturers about any features or limitations of products mentioned. Neither the editors nor the publisher assume any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material mentioned in this publication. POSTMASTER: Correspondence regarding subscriptions or change of address should be directed to CIRCULATION DIRECTOR, Rheumatology Practice Management™, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Fax: 732-992-1881. Yearly subscription rates: 1 year: $99.00 USD; 2 years: $149.00 USD; 3 years: $199.00 USD.
In This Issue
Continued from page 3
Federal Government Outlines Stage 3 of Meaningful Use...................................................................... 12 Rosemary Frei, MSc
Why You Need Disability Insurance: A Doctorâ€™s Story....................................................................... 13 Stuart E. Lowenkron, MD
Disability Insurance: Deciphering the COLA Rider............................................................................ 14 Lawrence B. Keeler, CFP, CLU, ChFC, RHU, LUTCF
EDITORIAL ADVISORY BOARD Editor-in-Chief Iris W. Nichols
President National Organization of Rheumatology Managers Wilmington, NC Practice Administrator Arthritis & Osteoporosis Consultants of the Carolinas Charlotte, NC
Director of Clinical Practice Arthritis & Rheumatism Associates, P.C. Wheaton, MD
Allyson D. Eakin, RN, OCN, CCM
Clinical Research Coordinator Arthritis & Osteoporosis Consultants of the Carolinas Charlotte, NC
Kyle C. Harner, MD
Linda S. McKee, EFPM
Practice Administrator Rheumatic Disease Associates Ltd Willow Grove, PA
Practice Administrator Premier HealthCare Associates, Inc Richmond, VA
Practice Administrator Piedmont Arthritis Clinic Greenville, SC
RHEUMATOLOGY PRACTICE MANAGEMENT
Carolina Arthritis Center Greenville, NC
Administrator North Texas Joint Care, P.A. Dallas, TX
I April 2015
Office Administrator Rheumatology Associates of South Texas San Antonio, TX
Business Manager Advanced Rheumatology Lansing, MI
Biosimilar Infliximab Entering Use in 12 European Countries Caroline Helwick
uropean physicians across 12 countries now have access to a more cost-effective treatment for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and other inflammatory conditions, with the approval of the first biosimilar monoclonal antibody for infliximab, CT-P13 (Remsima, Celltrion; Inflectra, Hospira), by the European Medicines Agency (EMA). A number of targeted biological therapies that have changed the face of immune-mediated inflammatory diseases are reaching patent expiry. Several biosimilar drugs have been developed, the aim being to achieve similar efficacy at a lower cost. Only a few have been approved by the EMA, and just one has been approved by the US Food and Drug Administration. Remsima has been launched in Austria, Belgium, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Spain, Sweden, and the United Kingdom. Clinical trials of the drug have demonstrated it is comparable to the originator, Remicade (Janssen Biotech), in safety, efficacy, and quality. While biologics have positively changed the treatment of patients with many inflammatory conditions, their relatively high cost has placed a burden on healthcare budgets and therefore on patient access to treatment. The availability of biosimilars is expected to offer significant cost savings, especially in the long-term treatment of patients with chronic inflammatory diseases.
According to an online article in the European Medical Journal,1 biosimilars are projected to save the European healthcare system between €11.8 and €33.4 billion ($13.2 billion and $37.4 billion) by 2020. The biggest savings are predicted in France, Germany, and the United Kingdom. The use of biosimilar monoclonal antibodies such as Remsima is expected to generate the greatest savings, according to the article.
Several biosimilar drugs have been developed, the aim being to achieve similar efficacy at a lower cost.
In a recent review article, the broader benefits and risks of Remsima were evaluated based on the drug’s clinical development data from the PLANETRA (Program evaluating the Autoimmune Disease iNvEstigational Drug cT-p13 in RA Patients) and PLANETAS (Programme evaLuating the Autoimmune disease iNvEstigational drug cT-p13 in AS patients) trials. “While there is growing interest in biosimilars and their potential to reduce the cost of treatment for a number of debilitating diseases, cli-
nicians and patients alike still have some questions,” wrote Henry Ireland, Drug Evaluations Commissioning Editor for Immunotherapy, “Using a detailed background on the clinical development of the first EMAapproved biosimilar monoclonal antibody, this article creates a useful framework for consideration of these new drug options.” The review addressed questions on critical topics, including biosimilarity (how similar is “similar”?), extrapolation (can data from one indication permit use in another?), switchability (can patients be switched from the originator to the biosimilar easily?), and immunogenicity (are there differences?). “Our review addressed these questions with respect to CT-P13. The drug is almost identical, and the EMA has accepted extrapolation for other conditions based on studies in rheumatoid arthritis and ankylosing spondylitis. The immunogenicity is considerable but the same as for infliximab. Finally, there are some encouraging data on switchability, but more real world data are needed,” said Jürgen Braun, MD, PhD, lead author. l
1. Webster Z. World’s first biosimilar monoclonal antibody launched in 12 European nations. European Medical Journal website. April 27, 2015. http:// emjreviews.com/press/worlds-first-biosimilar-mono clonal-antibody-launched-in-12-european-nations/. Accessed April 29, 2015. 2. Braun J, Kudrin A. Progress in biosimilar monoclonal antibody development: the infliximab biosimilar CT-P13 in the treatment of rheumatic diseases. Immunotherapy. 2015;7(2):73-87.
Cautious Stance Taken by…Continued from the cover The statement lists 8 cautionary points,1 including that the size, complexity, and heterogeneity of biosimilars necessitate “a greater degree of scrutiny” than small-molecule generics; that cliniE. William St. Clair, MD cal trials are necessary to “provide the necessary level of confidence for their use”; and that biosimilars “must have distinct names” to clearly differentiate them from the original products and to allow ongoing tracking of postmarketing adverse events. The statement also notes that only the prescribing provider should make the decision to prescribe the originator biologic or substitute a biosimilar, but that they also have the right to “dispense as written.” A joint letter to the Center for Drug Evaluation and Research of the FDA written by officials of the ACR and the Arthritis Foundation prior to the Zarxio approval also made the case for distinct names, including that “biosimilars are not bioequivalent. Biosimilars are not exact replicas of the innovator biologic.”3 ACR president, E. William St. Clair, MD, told Rheumatology Practice Management in a recent telephone interview that “there’s some hesitancy among rheumatologists in switching from a successful drug to a potentially less successful drug…. The chances that the biosimilar is effective are quite high….But you also worry about smaller companies with less experience in manufacturing bringing drugs onto the market.…Small changes in the manufacturing process and formulation of the drug can mean significant differences in efficacy and safety.” Biosimilars are copies of large bio-
logic molecules, such as monoclonal antibodies (mAbs), that have the same molecular sequence. One rheumatology biosimilar mAb, Inflectra (infliximab, Hospira), has been approved in Canada,4 based on 2-year clinical trials and additional follow-up in patients with rheumatoid arthritis and ankylosing spondylitis around the world, including Europe—where it has also been approved.5,6 No biosimilar mAbs have yet been approved by the FDA in the United States. Experience around the world has shown that biosimilars are significantly less expensive than the brand-name equivalents—and an ACR press release about the position statement acknowledges this by quoting St. Clair, stating that “biosimilars provide an opportunity to reduce treatment costs.”7 However, this is immediately followed in the news release by his caveat that “close monitoring of possible differences in the safety and efficacy of biosimilars and interchangeable biologics is needed as they enter the market. It is uncertain whether patients will respond to these drugs the same way they would an original biologic, because biologics are very sensitive to manufacturing changes.” Rheumatology Practice Management contacted Hospira for a comment. Julie Ferguson, Senior Manager of Global Public Affairs at Hospira, Inc., in Lake Forest, Illinois, responded via email that Hospira has great respect for the ACR’s commitment to rheumatology patients, but the company has a different perspective. “Thousands of patients in Europe, Australia, and elsewhere have already benefited from the increased choices and savings provided by biosimilar medicines, and we’re encouraged that the FDA has taken a major step to allow American patients to
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share in these benefits by approving the first biosimilar in the United States earlier this month [March],” wrote Ferguson. “We look forward to sharing our expertise and experience with the College to provide information on the strong track record of safety and effectiveness of these medicines. This is an exciting time for ACR and the patients they serve, as soon, people in the US suffering from these chronic diseases will have access to safe, effective and more affordable biologics.” l
1. American College of Rheumatology. Position statement: biosimilars. www.rheumatology.org/Practice/ Clinical/Position/Position_Statements/. Published February 2015. Accessed March 24, 2015. 2. FDA approves first biosimilar product Zarxio [news release]. Silver Spring, MD: US Food and Drug Administration; March 6, 2015. www.fda.gov/ NewsEvents/Newsroom/PressAnnouncements/ucm 436648.htm. Accessed March 24, 2015. 3. Arthritis Foundation and American College of Rheumatology. December 22, 2014, letter to Caleb Briggs, PharmD, of the Center for Drug Evaluation and Research, US Food and Drug Administration. www.arthritis.org/Documents/Sections/Advocate/ Joint-ACR-AF-Comments-to-FDA-Oncologic-DrugsAdvisory-Committee-January-7-2015.pdf. Accessed March 24, 2015. 4. Health Canada, Drugs and Health Products. PrRemsima: summary basis of decision (SBD) for Remsima. www.hc-sc.gc.ca/dhp-mps/prodpharma/sbdsmd/drug-med/sbd_smd_2014_remsima_160195-eng. php. Updated October 6, 2014. Accessed March 24, 2015. 5. Yoo DH, Prodanovic N, Jaworski J, et al. Efficacy and safety of CT-P13 (infliximab biosimilar) over two years in patients with rheumatoid arthritis: comparison between continued CT-P13 and switching from infliximab to CT-P13. Presented at: American College of Rheumatology 2013 Annual Meeting; October 25-30, 2013; San Diego, CA. Abstract L1. http://acrabstracts. org/abstracts/efficacy-and-safety-of-ct-p13-infliximabbiosimilar-over-two-years-in-patients-with-rheumatoidarthritis-comparison-between-continued-ct-p13-andswitching-from-infliximab-to-ct-p13/. Accessed March 24, 2015. 6. Park W, Miranda P, Brzosko M, et al. Efficacy and safety of CT-P13 (infliximab biosimilar) over two years in patients with ankylosing spondylitis: comparison between continuing with CT-P13 and switching from infliximab to CT-P13. Presented at: American College of Rheumatology 2013 Annual Meeting; October 25-30; San Diego, CA. Abstract L15. http:// ww2.rheumatology.org/apps/MyAnnualMeeting/ AbstractPrint/39201. Accessed March 24, 2015. 7. American College of Rheumatology releases new position statement on biosimilars: encourages oversight, scientific study & physician involvement [news release]. Atlanta, GA: American College of Rheumatology; March 12, 2015. www.rheumatology. org/about/newsroom/index.asp. Accessed March 24, 2015.
The SARAH Study: A Trial and…Continued from the cover for patients with RA and qualitatively described the experience of the participants. The pragmatic, multicentered, individually randomized controlled trial and the embedded qualitative study included 490 adult patients from 21 rheumatology and therapy departments in 17 National Health Service trusts in England. Patients with RA were eligible for the study if they had been on stable medication for ≥3 months to treat pain and dysfunction of the hands and/or wrists. The 2 study groups were: usual care, which provided education, general exercise advice, and functional splinting if needed (n=244); and usual care plus a per-
sonalized exercise program comprising 6 sessions of strengthening and stretching exercises with a hand therapist, daily home exercises, and adherence strategies (n=246). Follow-up evaluations were at 4 and 12 months after randomization. The primary outcome was the Michigan Hand Outcome Questionnaire (MHQ) overall hand function subscale score recorded at 12 months. The health economics evaluation was based on the European Quality of Life-5 Dimensions and medication and healthcare use. Outcomes were obtained for 89% of participants at 12 months (222 in usual care and 216 in the exercise program).
For the primary outcome, there was a statistically significant difference in favor of the exercise program. Imputed analysis produced incremental cost-effectiveness ratio estimates of £17,941 [$26,812.75] (0.59 probability of cost-effectiveness at willingness-to-pay threshold of £30,000 [$44,834.87] per quality-adjusted life-year). The researchers concluded that the results of the trial suggest that the addition of an exercise program to usual care for patients with hand/wrist RA is clinically effective and cost-effective when compared with usual care alone. Williams MA, et al. Health Technol Assess. 2015;19(19):1-222. l
Haplotypes Associated With RA Severity, Mortality, and Treatment Response Caroline Helwick
ew findings suggest that severity, mortality, and treatment response among persons with rheumatoid arthritis (RA) can be predicted based on genetic haplotype. The international study was led by Sebastien Viatte, MD, PhD, of the Arthritis Research UK Centre for Genetics and Genomics at the University of Manchester in England. All patients were from the United Kingdom and self-reported themselves as white. “Advances have been made in identifying genetic susceptibility loci for autoimmune diseases, but evidence is needed regarding their association with prognosis and treatment response,” Viatte and
colleagues wrote in their article.1 The study assessed whether specific HLA-DRB1 haplotypes associated with RA susceptibility might also be associated with radiological severity, mortality, and response to tumor necrosis factor (TNF) inhibitors. The Norfolk Arthritis Register (NOAR) of 1691 patients and 2811 radiographs (recruitment took place from 1989-2008, with 2008 as the final follow-up) was used as the discovery cohort, while the Early Rheumatoid Arthritis Study of 421 patients and 3758 radiographs (recruitment from 1986-1999, with 2005 as the final follow-up) served as the independent replication cohort for studies of radiographic outcome.
Evaluation of treatment response came from the Biologics in Rheumatoid Arthritis Genetics and Genomics Study Syndicate cohort of 1846 patients enrolled at the start of TNF inhibitor therapy (occurrence from 2006-2007, with 2011 as the final follow-up). Mortality was assessed in the NOAR cohort. Sixteen HLA-DRB1 haplotypes defined by amino acids at positions 11, 71, and 74 were included in the analysis. Radiological outcome used the Larsen score (0 [none] to 200 [severe joint damage]) and erosions of the hands and feet on radiographs. Other outcomes were all-cause mortality and treatment response as measured by change in Disease Activity Score. Continued on page 9
Topical Treatment of Osteoarthritis Continued from the cover
Shelly Kafka, MD
Wesley A. Kafka, PharmD candidate
with OA. The guidelines promote nonpharmacologic therapy and the use of acetaminophen, topical or oral nonsteroidal anti-inflammatory agents (NSAIDs), and finally opioids if other therapies fail. Physicians are hesitant to use opioids for many reasons, but particularly because of abuse and stricter monitoring by states. Physicians are also reluctant to use NSAIDs because of the risk of renal, gastrointestinal, and cardiovascular side effects, to which elderly patients are particularly vulnerable. More and more patients and doctors are turning to topical agents as an alternative. Is there good evidence to support the use of topical medication for the treatment of arthritis? Diclofenac sodium gel 1% (Voltaren Gel, Novartis Consumer Health) is a topical NSAID that was approved by the US Food and Drug Administration (FDA) in 2007 for the treatment of OA.4 Diclofenac gel 1% was studied in 513 patients with OA of the knee and 400 patients with OA of the hands.4 These studies had placebo-controlled periods of up to 6 to 12 weeks, with results showing about a 50% reduction in pain (46% in hand, 51% in knee).5 Uncontrolled safety studies of up to 12 months’ duration revealed the medication was well tolerated, with 7% experiencing skin reactions.4 Diclofenac gel does carry similar
labeling as oral NSAIDs, despite an approximate 6% absorption rate.6 Additionally, there are nonprescription topical agents that mainly use menthol and methyl salicylate as their active ingredients. Unfortunately, it is difficult to study the efficacy of these products.7 Recently, another alternative for analgesic relief of a number of conditions has become a viable option, and that is the use of compounding creams. A variety of local and national compounding pharmacies compound oral analgesics, antidepressants, anticonvulsants, muscle
Is there good evidence to support the use of topical medication for the treatment of arthritis?
relaxants, anti-inflammatories, and a number of other ingredients into a cream base. These compounded creams, while not FDA approved for any indication, have garnered countless patient testimonials praising their use. I have used some of these creams in my practice with moderate success, especially for OA of the hands and feet. There is no doubt that compounding pharmacies are being aggressive in marketing to doctors. Within a period of 6 months, I encountered 5 representatives trying to peddle their versions of compounding creams. I was also approached by a company to do a “study” using their compounding creams, whereby patients would fill out surveys at the start of treatment and again after having
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used the cream for a certain time span to document their pain levels and progress. Physicians participating in these studies receive compensation for each patient completing the study. Regrettably, some pharmacists have risked having their licenses suspended because they accepted kickbacks involving a massive compounding fraud scheme.8 Workers’ compensation insurance has also been faced with considerable prescription bills for compounded creams.8,9 For example, in 2006, California’s Division of Workers’ Compensation was billed $10 million for compounded creams; by 2013 that number had increased to more than $145 million.8 The cost of compounded creams has also increased greatly over the years, with charges ranging up to hundreds of dollars and in some cases over thousands per prescription.8 Insurers have taken notice, and many no longer will cover compounded creams.9 Congress has passed legislation that should improve the federal oversight of compounding pharmacies; however, the FDA still lacks the unequivocal authority to regulate compounding medications.10 Nevertheless, patients do report pain relief with these creams. Particularly, patients with neuropathic pain have reported benefit with such topical medications as lidocaine 5% patches (Lidoderm, Endo Pharmaceuticals), which is FDA approved for postherpetic neuralgia syndrome and other focal neuropathic syndromes.7,11 Some of my patients with OA also report benefit with lidocaine 5% patches, likely due to its topical anesthetic properties. Often compounded creams will combine lidocaine with diclofenac, amitriptyline, and/or
gabapentin. Again, there is little evidence that these combinations are more effective than a single ingredient or even better than placebo. However, short-term safety studies have not noted any severe adverse events. In my practice, the only side effects noted with any frequency were topical irritation or rashes that resolved with discontinuation of use. Certainly, studies would be required to provide long-term safety and capture serious adverse events. Since these products are not regulated, there is little chance of long-term monitoring. What is a clinician who treats OA to do? Injections into joints often have short-term benefit, but patients do not want long-term treatment with injections, and there can be risks associated with repeated injections. Likewise, many patients cannot take narcotics or NSAIDs. Although rheumatologists do follow American College of Rheumatology guidelines, there is frustration that we do not have better medications for the treatment of pain associated with OA. Topical agents are poorly covered by Medicare, whereas compounded creams are not covered
at all; thus, patients must resort to paying high out-of-pocket costs for these medications. It seems clear that studies are needed to document efficacy and safety of topical agents, and pharmacoeconomic studies are needed to look at long-term outcomes, especially if these agents
Topical agents are poorly covered by Medicare, whereas compounded creams are not covered at all.
can help reduce comorbidities such as cardiovascular disease, gastrointestinal bleeds, and renal failure. Positive outcomes from these studies could drive insurers to provide coverage for these topical medications. Until then, physicians and patients should be made aware of the benefit/cost ratio in regard to topical medications, including compounded creams. l
1. Hootman JM, Helmick CG. Projections of US prevalence of arthritis and associated activity limitations. Arthritis Rheum. 2006;54(1):226-229. 2. Centers for Disease Control and Prevention (CDC). Prevalence and most common causes of disability among adults—United States, 2005. MMWR Morb Mortal Wkly Rep. 2009;58(16):421-426. 3. Hochberg MC, Altman RD, April KT, et al; American College of Rheumatology. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken). 2012;64(4):465-474. 4. Voltaren [package insert]. Parsippany, NJ: Novartis Consumer Health, Inc; October 2009. 5. Barthel HR, Haselwood D, Longley S 3rd, et al. Randomized controlled trial of diclofenac sodium gel in knee osteoarthritis. Semin Arthritis Rheum. 2009;39(3):203-212. 6. Kienzler JL, Gold M, Nollevaux F. Systemic bioavailability of topical diclofenac sodium gel 1% versus oral diclofenac sodium in healthy volunteers. J Clin Pharmacol. 2010;50(1):50-61. 7. Jorge LL, Feres CC, Teles VE. Topical preparations for pain relief: efficacy and patient adherence. J Pain Res. 2010;4:11-24. 8. Forshay K. The price of pain: questionable marketing, loose oversight of compound creams—parts 1-3. 89.3 KPCC Southern California Public Radio website. www.scpr.org/news/2014/09/09/46554/the-priceof-pain-high-costs-spur-questions-about/. Published September 10, 2014. Accessed March 2, 2015. 9. Webb G. Compounding pharmacies engaging in profiteering with “designer medications”? The Legal Examiner. August 25, 2014. http://charlottesville. legalexaminer.com/uncategorized/compounding-phar macies-profit-from-designer-medications. Accessed March 2, 2015. 10. Goldman TR. Health policy briefs: regulating compounding pharmacies. Health Affairs website. www.healthaffairs.org/healthpolicybriefs/brief. php?brief_id=114. Published May 1, 2014. Accessed March 2, 2015. 11. Comer AM, Lamb HM. Lidocaine patch 5%. Drugs. 2000;59(2):245-249.
Haplotypes Associated With RA… Continued from the page 7 The investigators found that among patients with RA, the HLADRB1 locus was associated with radiological severity, mortality, and treatment response—this locus is associated with disease susceptibility. Specifically, patients with RA and valine at position 11 of HLA-DRB1 had the strongest association with
radiological damage. The percentages of patients with joint erosions were 48% among noncarriers of valine at position 11, 61% among heterozygote carriers, and 74% among homozygote carriers at year 5. Valine at position 11 also carried a higher risk of mortality in patients with inflammatory polyarthritis and
with better treatment response to TNF inhibitors. A moderate or good response was observed among 81% of heterozygote carriers and 86% of homozygote carriers. l
Viatte S, Plant D, Han B, et al. Association of HLA-DRB1 haplotypes with rheumatoid arthritis severity, mortality, and treatment response. JAMA. 2015;313(16):1645-1656.
NORM Celebrates 10 Years
he National Organization of Rheumatology Managers (NORM) is celebrating its 10th anniversary this year. In 2005, the rheumatologists who had created the Coalition of State Rheumatology Organization held a meeting that included almost 50 physicians and practice managers. This group determined that office managers should be significantly involved in the practice management issues that are specific to the field of rheumatology. Comprising rheumatology professionals, including practice managers, administrators, and physicians, the group’s mission statement promises that NORM will be “a forum by which we promote and support education, expertise, and advocacy for rheumatology practices and their patients.” The ensuing decade saw sustained growth in membership and continued efforts to meet operational objectives and challenges. Dave
Rothhaas, past president of NORM, noted, “To think we started with 25-35 practice manager members, and as we come up on our 10th anniversary, we have close to 300 plus members in 43 states.”
We promote and support education, expertise, and advocacy for rheumatology practices and their patients. As stated on its website, NORM “promotes professional development through peer interaction and educational programs.” The organization’s objectives include promoting cooperation, understanding, and fellowship among its members;
becoming aware of problems faced by rheumatology medical practices and working toward their resolution; and providing opportunities for members to network and share their knowledge and expertise. NORM is justifiably proud of the many resources available to its members, including its listserv tool, website, and webinars, that provide information about such topics as government policies, billing and coding, personnel issues, and advocacy concerns. NORM will be holding its 2015 Practice Managers Conference and 10th Anniversary Celebration in Bellevue, Washington, September 17-19. According to Paul H. Caldron, DO, FACP, FACR, MBA, Arizona Arthritis and Rheumatology Associates, “NORM has truly come of age. This is where the ‘business’ of rheumatology gets learned.” For more information about this growing organization, visit www.normgroup.org. l
A forum for members of the rheumatology team to have a discussion on the day-to-day operations of running a business. The goal is to share ideas and best practices, and provide a resource to ultimately help run a more efficient practice and improve patient care.
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SGR Repealed, But the Work Is Just Beginning Gail Thompson
he Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) was signed into law on April 16, making history not just by repealing the sustainable growth rate (SGR) formula for Medicare physician payment, but for the resounding bipartisan support of the legislation after decades of partisan posturing in the US House of Representatives and Senate. The House of Representatives approved the bill by a 392–37 vote, and the Senate followed a few weeks later with an approval vote of 92–8. These landslide votes were achieved by actual compromise on both the Democratic and Republican sides, which by itself is noteworthy. “After more than a decade of uneven progress, it’s almost overwhelming to think that more than 90 percent of Congress finally voted to repeal the SGR,” said Rep Michael C. Burgess, MD (R, Texas), who sponsored the legislation. “With bipartisan strength, we passed the most meaningful entitlement reform in years with a product that’s a huge victory for seniors, providers, taxpayers, and the integrity of the entire Medicare system.” Many details of the signed bill are yet to be defined, however, and will have a lasting and profound impact on healthcare delivery for decades. The SGR formula calculation that was to have managed costs of medical care has been replaced by a modest 0.5% annual payment update for the next 5 years for all physicians, as well as a merit-based incentive payment system (MIPS) for all physician payments beginning January 1, 2019. MIPS payments will be based on measures and criteria that are yet to be defined. The secretary of the US Department of Health & Human
Services is tasked under the law to “assess appropriate adjustments to quality measures, resource use measures, and other measures used under the MIPS; and…assess and implement appropriate adjustments to payment adjustments, composite performance scores, scores for performance categories, or scores for mea-
“With bipartisan strength, we passed the most meaningful entitlement reform in years with a product that’s a huge victory for seniors, providers, taxpayers, and the integrity of the entire Medicare system.”
—Rep Michael C. Burgess, MD (R, Texas)
sures or activities under the MIPS.” The legislation calls for performance assessments in 4 key areas: quality of care, resource use, clinical practice improvement (including expanded practice access, population management, care coordination, beneficiary engagement, and patient safety and practice assessment improvement activities), and the meaningful use of certified electronic health record (EHR) technology. It also extends the Children’s Health Insurance Program (CHIP) and the Maternal, Infant, and Early Childhood Home Visiting program, and continues certain assistance programs for qualifying Medicare and Medicaid beneficiaries.
Next Steps Medicare has to adjust the payment rates in its systems to reflect the final law; however, Medicare assures practices that it will continue to process claims on a timely basis and that any claims that may have been processed with the SGR-driven 21% reduction in physician payments will be reprocessed. New and final 2015 rates will be applied and payments adjusted without further action needed by the physician practices. Congress and the Centers for Medicare & Medicaid Services (CMS) have not yet begun to elaborate on how the new value-based payment models will transition, or how the new alternative payment mechanisms will work. Bundled payment initiatives already are being explored, but with mixed results. Some CMS alternative model pilots have seen mixed success, with both reported savings as well as a number of participants dropping out, citing concerns for their continued financial viability based on the costs of participating in comparison to the financial return. Pundits are expressing concern about the final direction of the MACRA legislation, warning that it will force doctors into hospital-run accountable care organizations with rules decreed by the federal government. Other concerns center on the lack of credible quality measurements for physicians. Going forward, as CMS moves to new definitions of value in healthcare, it is clear from ongoing reform initiatives that there will be both winners and losers. Discussions to define the intent and execution of the MACRA legislation will continue, and providers should remain vigilant to monitor developments regarding this legislation as well as key details that are not yet finalized. l
Federal Government Outlines Stage 3 of Meaningful Use Rosemary Frei, MSc
riteria for Stage 3 of Meaningful Use was announced and published at the end of March, detailing benchmarks that eligible providers and hospitals will have to meet to qualify for certain incentive payments and avoid reimbursement penalties. The proposed ruling by the US Department of Health & Human Services and the Centers for Medicare & Medicaid Services (CMS) outlines a framework that is in some ways more flexible and in others more rigid than Stage 1 and Stage 2. “These changes…support our broader efforts to increase simplicity and flexibility in the program while driving interoperability and a focus on patient outcomes in the meaningful use program,” according to a summary of the proposed rule. As part of Stage 3, providers will need to attest to 2 of 3 measures associated with each of the main categories of Meaningful Use: coordination of care through patient engagement, health information exchange, and public health reporting. Providers may continue to use 2014 edition electronic health record (EHR) technology through 2017. There are still exceptions for providers in rural areas or who practice at more than 1 location, as well as for lack of availability of internet access, newly practicing providers and hospitals, and unforeseen circumstances such as natural disasters. In addition, the thresholds of most measures have been increased, such as having to use computerized provider order entry (CPOE) systems for >80% of all prescriptions (up from 50% in Stage 2), >60% of all laboratory test orders, and >60% of diagnostic imaging orders. Furthermore, Stage 3 also requires that >80% of all patients seen by a provider or discharged from
a hospital or emergency department have access to their health information within 24 hours of its availability to the provider. Compliance with Stage 3 requirements will be optional for providers in 2017, but mandatory for all eligible providers starting in 2018 regardless of previous participation in Stage 1 or Stage 2. CMS also intends Stage 3 to be the last stage of Meaningful Use.
The proposed ruling outlines a framework that is in some ways more flexible and in others more rigid than Stage 1 and Stage 2.
“The incorporation of the requirements into one stage for all providers is intended to respond to stakeholder input regarding the complexity of the program, the success of certain measures which are part of the meaningful use program to date, and the need to set a long-term, sustainable foundation based on a consolidated set of key advanced use objectives for the Medicare and Medicaid EHR Incentive Programs,” according to the executive summary. Other key conditions in Stage 3, in addition to the raised thresholds described previously, include the following: • Reporting for a full calendar year starting in 2017 for nearly all providers instead of 90 days • Successfully meeting the criteria associated with each of 8 specified
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program objectives (protect patient health information, electronic prescribing, clinical decision support, CPOE, patient electronic access to their health information, coordination of care through patient engagement, health information exchange, and public health and clinical data registry reporting); in measures with 3 subsets, achieving at least 2 of the 3 • Using secure messages via the electronic messaging function of EHRs to communicate with more than 35% of patients • For more than 40% of new patients and for more than 50% of existing patients being transitioned to other care facilities or providers, creating a summary of the care record in the EHR and sending it electronically to the new providers/facilities. The executive summary states that the “stage 3 proposed rule would… focus on the advanced use of EHR technology to promote improved patient outcomes and health information exchange.…[It also] would further support efforts to align the EHR Incentive Programs with other CMS quality reporting programs that use certified EHR technology, such as the Hospital Inpatient Quality Reporting (IQR) and Physician Quality Reporting System (PQRS) programs, as well as continue alignment across care settings for providers demonstrating meaningful use.” CMS has given providers and other stakeholders 2 months to submit comments regarding this rule from the date the rule was published. Comments and feedback are due by May 29 and can be submitted by visiting www.regulations.gov and referring to file code CMS-3310-P. l
Why You Need Disability Insurance: A Doctor’s Story Stuart E. Lowenkron, MD, Associate, Physician Financial Services
embers of the medical profession sacrifice their time and energy without reservation for the care of patients. All too often, however, it is done to the detriment of themselves and their families—especially in the areas of personal financial planning. Many physicians opine the cost of the various insurance policies we purchase, whether life insurance, homeowners insurance, or disability insurance. We forget, as I almost did, that we need these policies to protect our most valuable asset: our ability to earn an income.
Early Career In the early 1990s, I was completing my fellowship. The future seemed bright, and it was time to take the first steps toward short-term and long-term planning for my family. At that early stage of my career, I thought there would be plenty of time to take care of these things. Since I was still relatively young and in good health, I wanted to concentrate on the present, and the future would take care of itself. At the urging of my personal and financial advisors, however, I purchased life insurance and disabil ity insurance, and began putting money into
tax-deferred accounts for the future. Unbeknownst to me, taking these steps, or more specifically, purchasing my disability insurance policy, would be among the most important and smartest decisions I would ever make.
Purchasing my disability insurance policy would be among the most important and smartest decisions I would ever make. Upon completion of my residency and fellowship training, I uprooted my young family to a small Southern town, where I had been recruited to set up shop as a specialist. Within 3 years, I had a thriving practice and started to build a comfortable lifestyle for myself and my family. Two years later, though, it was gone: my home, my family as a result of divorce, my practice, my money, and my friends. The primary reason was my health. I had begun to suffer from major depression, a disease that would follow me and impact the rest of my life.
DEPRESSION: FACTS AND FIGURES n Depression affects nearly 1 in 10 adults each year, and women are more likely to experience the disorder than men. n Biochemistry, genetic, personality, and environmental factors can all play roles in a person’s depression. n For a diagnosis of depression, symptoms must last for ≥2 weeks. n Depression is one of the most treatable mental disorders, with 80% to 90% of people with depression eventually responding well to treatment. Source: American Psychiatric Association.
The Impact of Depression For me, depression has manifested in a number of ways, including profound sadness and severe fatigue, often with an inability to get out of bed. Difficulty concentrating would result in mental paralysis, often impairing my ability to perform even the simplest of tasks. Taking care of patients always seemed to be the easy part of my job, but dealing with my depression and taking care of myself was a different story. I have been battling this disease a good part of my life, have been in and out of treatment and taking medication since I was in my 20s, and it has been an exhausting mental and physical endeavor. The most significant of all the problems at the onset of the disease and at points throughout my medical career was an inability to work, with subsequent loss of income and the inability to support and care for myself and my family. In my third year of private practice, my health deteriorated significantly. I finally reached a point where I became overwhelmed and “paralyzed”; I was unable to work, and eventually I had to give up my practice. All of a sudden I had no income and an overwhelming number of problems, and I was barely able to function due to serious depression. The Silver Lining Despite these problems, I had 2 things going for me that essentially saved me. First, when I bought my disability and life insurance policies, I began a relationship with the agent who sold them to me that has lasted more than 20 years. He did not just sell me a policy and disappear. He kept in touch with me to see how things were going and whether there Continued on page 14
Why You Need Disability Insurance... Continued from page 13 was anything else he could help me with; he ultimately became a loyal friend. In fact, it was he who reminded me about the second thing I had going for me: the disability insurance policy that I had not wanted to purchase several years before. The insurance policies that I complained about having to purchase, believing I was probably never going to need them, became of utmost importance. Like most physicians who deal with disabled patients, I found it hard to believe that I had become one of them. The monthly income from my disability insurance policy saved my life. After a few years, I felt I was ready to return to work. I would
need to return to employment as a new employee of either a hospital
The insurance policies that I complained about having to purchase became of utmost importance. or someoneâ€™s private practice. How would I make it work financially? I was residing in an area with a higher cost of living; I had remarried and was granted custody of my children.
I also needed to purchase a home. It appeared that if I wanted to continue to live where I was, I was going to have to work for a lot less money than I had been earning previously. With income from my disability insurance policy, I was able to do this once again. It contained a rider that would pay benefits, proportionate to my loss of income, even though I was still working in my original field (see related article on this page). Although I believed I was no longer sick, my income was. With a little lifestyle adjustment, the salary I would earn plus the supplemental income I received from my disability policy allowed me to take a job at a hospital, followed by a move back
Disability Insurance: Deciphering the COLA Rider Lawrence B. Keller, CFP, CLU, ChFC, RHU, LUTCF
f you are unable to work due to a sickness or injury, disability insurance can help you meet your expenses and maintain your standard of living. One of the options available when purchasing an individual disability insurance policy is the cost of living adjustment (COLA) rider.
What Is the COLA Rider? The COLA rider is designed to help your disability insurance benefit keep pace with inflation. These riders generally adjust your policyâ€™s monthly benefit on an annual basis, based on a fixed percentage or tied to the consumer price index after you have been disabled for 12 months. These adjustments apply to total and residual disabilities and can be based on a simple or compound basis. Although expensive, this rider can provide signifi-
cant increases to your monthly benefit if you are disabled early in your career.
Is the COLA Rider Worth Purchasing? My general rule is that the younger you are and the fewer assets you have accumulated, the more imporÂtant the COLA rider is and the more it should be part of your policy. However, if you are
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not opting for the maximum amount of coverage that you qualify for based upon your earned income, you should consider removing the COLA rider and using the dollars you would have allocated to the COLA rider to purchase a larger monthly benefit. Remember, the COLA rider will not increase your monthly benefit until you have been disabled for 12 months. Therefore, if you are not disabled for a long-term period, and have been paying premiums for a COLA rider, you may not realize much of an economic benefit from the rider.
Do the Math Assume that you are a 35-yearold male hematologist-oncologist in New York earning $290,000 per year. You were planning to purchase $10,000 per month of indi-
into private practice. Both paid well below what I needed, but I was able to support my family until my salary increased to something more in line with my cost of living.
A New Beginning Unfortunately, after working fulltime for 6 more years, I once again became too sick to work and had to claim total disability. After about a year and a half, and much discussion with family, friends, and medical professionals, I made a life-changing decision: I changed professions. Although I would always be a doctor, my medical condition would no longer allow me to actively practice clinical medicine, and I changed course to something that would provide a more
favorable work environment. I now devote my time and energy, using my experience, to make sure physicians and other healthcare professionals have the same type of income protection in place. Life has taught me a valuable lesson. Unfortunately, in the medical profession, we are too busy or do not realize that taking steps early in our career can help us avoid mistakes that can be financially devastating. Thankfully, my disability insurance policy contained a valuable “own occupation” definition of total disability that allows me to continue to receive monthly income until age 65 years, regardless of my ability to work in another profession. In addition, my benefits also increase annually
due to the cost of living rider that I purchased. I am now, once again, able to provide for my family while working in a profession more conducive to my medical issues. Without my disability policy, which I did not want to buy and cursed every time I paid a premium, I do not know how my family and I would have survived. I am so glad I never had to find out. l
vidual coverage from an established insurance company (you qualified for $13,000 per month, but wanted to reduce your premium outlay), payable after 90 days of disability to age 65 years with an enhanced residual disability rider and a 3% compound COLA rider. The monthly premium would be $267, including a 10% association discount. If you removed the COLA rider, the monthly premium would be reduced to $203; this is a savings of $64, or approximately 24% of the cost of the policy. If you took that premium savings, how much additional monthly benefit would that allow you to purchase? A policy for $13,000 per month, payable after 90 days to age 65 years would have a monthly premium of $262, including a 10% association discount. This is almost identical to the premium for the $10,000 monthly benefit with the COLA rider included. In this scenario, does it make sense to forgo the COLA rider? What is the break-even period? That is easy to calculate. If you
took $10,000 monthly and invested it at a 3% compound rate of return, in 10 years (1 year of disability plus 9 years of investing at 3%), the $10,000 would grow to $13,048. By the same token, if you purchased a policy with a $10,000 monthly benefit and a 3% compound COLA rider, the maximum potential benefit for total disability (assuming a total disability began on the effective date of the policy and continued until the age of 65 years) would be $5.70 million. If you purchased a policy with a $13,000 monthly benefit and no COLA rider, the maximum potential benefit for the same disability would be $4.64 million. Ideally, should you decide to purchase the COLA rider, I would suggest one that is compounded, and the higher the maximum is the better, taking overall policy premiums into consideration. While the example above utilized the sample company’s 3% compound COLA rider, a similar anal-
ysis can easily be done for most insurance companies.
Stuart E. Lowenkron, MD, is an associate of Physician Financial Services, a New York–based firm specializing in income protection and wealth accumulation strategies for physicians. He can be reached at 800-481-6447 or by email to Slowenkronmd@physicianfinancial services.com with comments or questions.
Summary The COLA rider is designed to help your disability insurance benefits keep pace with inflation. Generally, the younger you are and the fewer assets you have accumulated, the more important the COLA rider is and the more it should be part of your policy. However, if you are not opting for the maximum amount of coverage that you qualify for based upon your earned income, you should consider removing the COLA rider and using the dollars you would have allocated to the COLA rider to purchase a larger monthly benefit. l Lawrence B. Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF, is the founder of Physician Financial Services, a New York–based firm specializing in income protection and wealth accumulation strategies for physicians. He can be reached at 800-481-6447 or by email to Lkeller@physicianfinancialservices.com.
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.
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Published on May 15, 2015