RPM August 2014 Vol 2, No 4 by Value-Based Cancer Care

august 2014

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Volume 2 • Number 4

Practice–Payer Relations

Practice Profile

Meeting Challenges in a Changing Landscape

Potholes in the System By Mark Post, Administrator, North Texas Joint Care, Dallas, TX

e are all familiar with the the necessary investment of time to notion of appealing insur- resolve these matters becomes frustratance denials of medication ing and daunting. An examination of coverage, claims, line item issues of practice–payer relations shows that An Interview with claims, and precertifications for proce- perhaps a more comprehensive evaluaKyle C. Harner, MD dures such as biopsies and imaging. tion of this system is needed. While following payer protocols may How often have we completed the eventually resolve an immediate issue, appropriate prior authorization, precerFOR OFFICE ADMINISTRATORS, RHEUMATOLOGISTS, PHYSICIAN ASSISTANTS, AND NURSE PRACTITIONERS Continued on page 12

From the Editor

Who Is Looking at the Big Picture?

arolina Arthritis Center sits in a welcoming brick building in the city of Greenville, NC. Approximately 90 miles west of the North Carolina coast, Greenville is home to East Carolina University, Vidant Medical Center, and numerous businesses, medical practices, and Continued on page 6

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

unzi, a Confucian philosopher born in 300 BC, is quoted as saying, “In order to properly understand the big picture, everyone should fear becoming mentally clouded and obsessed with one small section of truth.”

Rheumatology practices are not unique in the way strategic planning is approached: managers and administrators spend the majority of their time focusing on minutia, and while minutia is critical to daily operations, it cannot be Continued on page 5

In partnership with

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

Time to Get on TRACK and RACE to Excellence Together!

o National O r ganizat ion of R heumatolo g y Ma n a gers Racing to Rheumatology Excellence Friday, September 12, 2014 and Saturday, September 13, 2014 Increase your odds of “being in the winner’s circle” by joining us for the 2014 NORM Conference where nationally known speakers will help NORM members race on the fast track rather than the sloppy track. Presentations and breakouts on topics such as MU2, OSHA, Customer Service, Physician and Team Engagement, and Financial Management of your practice will help your practice win the race. The conference will end with a presentation on Understanding the Impact of ICD-10 and an ICD-10 workshop stocked with take-aways for your practice. This year NORM has added 6 product theatres offering attendees the opportunity to be hands-on with some products. NORM membership also provides access to the NORM listserv and education portal. The listserv allows NORM members to seek answers to their practice and nationwide issues from members across the country. The educational portal provides access to training and informational presentations as well as sample documents. Conference Registration is Now Open | 2014 Dues and Conference Registration $250

For more information contact NORM at info@normgroup.org or visit our website www.normgroup.org “Of all the practice management resources out there, none are as relevant and as valuable to me as my NORM membership. With benefits like the member listserv and an affordable annual conference, the NORM group provides a forum for mentorship, education, professional feedback, cutting edge ideas and inspiration.” Jay Salliotte

Diamond Level Corporate Member - Janssen Biotech, Inc

Platinum Level Corporate Member - Celgene Corp

In This Issue

PUBLISHING STAFF Senior Vice President/Group Publisher Nicholas Englezos nenglezos@the-lynx-group.com Director, Client Services Zach Ceretelle zceretelle@the-lynx-group.com Editorial Directors Dalia Buffery dbuffery@the-lynx-group.com Anne M. Cooper acooper@the-lynx-group.com Associate Editor Lara J. Lorton

august 2014

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Volume 2 • Number 4

Editorial Assistants Jennifer Brandt Cara Guglielmon Production Manager Melissa Lawlor The Lynx Group President/CEO Brian Tyburski Chief Operating Officer Pam Rattananont Ferris Vice President of Finance Andrea Kelly Human Resources Jennine Leale Associate Director, Content Strategy & Development John Welz Director, Quality Control Barbara Marino Quality Control Assistant Theresa Salerno Director, Production & Manufacturing Alaina Pede

From the Editor

Who Is Looking at the Big Picture?.......................................................... 1 By Iris W. Nichols

Practice Profile

Meeting Challenges in a Changing Landscape: FORInterview OFFICE ADMINISTRATORS, RHEUMATOLOGISTS, PHYSICIAN ASSISTANTS, AND NURSE PRACTITIONERS ..................................................... 1 An with Kyle C. Harner, MD Practice–Payer Relations

Potholes in the System................................................................................ 1 By Mark Post

Data Management

ACR Facilitates PQRS Compliance Efforts........................................... 10 By Rosemary Frei, MSc

Director, Creative & Design Robyn Jacobs

Continued on page 4

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 Manager Jini Gopalaswamy Project Coordinators Mike Kodada Deanna Martinez IT Specialist Carlton Hurdle Executive Administrator Rachael Baranoski Administrative Coordinator Stephanie Ramadan Office Coordinator Robert Sorensen Engage Healthcare Communications, LLC 1249 South River Road - Ste 202A Cranbury, NJ 08512 phone: 732-992-1880 fax: 732-992-1881

BPA Worldwide membership applied for January 2014.

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

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

August 2014

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In This Issue

Continued from page 3

Physician–Hospital Alignment Series

Do’s and Don’ts in Physician–Hospital Alignment, Part 2................................................................. 14 By Max Reiboldt, CPA

Patient Education

The Impact of Patient Education on Disease Outcomes................................................................. 18 By Deanna L. Owens, RN, MSN

Best Practices

Ceasing All RA Medications Not Optimal in Patients Trying to Conceive...................................... 20 By E.K. Charles

Wealth Management

New IRA Rollover Rules Issued by the IRS............................................................................................ 23 By Lawrence B. Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF

Patient Assistance Programs

Otezla SupportPlus Offers Comprehensive Patient Assistance....................................................... 26 Drug Update

Otezla (Apremilast), an Oral PDE-4 Inhibitor, Receives FDA Approval for the Treatment of Patients with Active Psoriatic Arthritis.................................................................................27 By Loretta Fala, Medical Writer

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

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

Ana Reyes-Cartagena

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

Allyson D. Eakin, RN, OCN, CCM

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

Kyle C. Harner, MD

Helen Hinkle

Linda McKee

Mark Post

Jay Salliotte

Practice Administrator Rheumatic Disease Associates Ltd Willow Grove, PA

Practice Administrator Premier HealthCare Associates, Inc Richmond, VA

Nancy Ellis

Practice Administrator Piedmont Arthritis Clinic Greenville, SC

Marjorie Collings

RHEUMATology Practice Management

Carolina Arthritis Center Greenville, NC

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

I August 2014

Office Administrator Rheumatology Associates of South Texas San Antonio, TX

Business Manager Advanced Rheumatology Lansing, MI

From the Editor

Who Is Looking at the...Continued from the cover the driving force of growth and stability. After hearing Xunzi’s philosophy recently, I realized it very much reminds me of what we do during the daily operations of a medical practice: we put out fires, focusing on each issue as it arises. Although we have all become proficient at firefighting, we may have also lost sight of long-term goals in the process. The other day a physician asked me, “Who is looking at the big picture?” After much thought and reflection on this question, I realized how profound this statement was. We seem to spend so much of our time addressing symptoms that we do not diagnose the disease; we are constantly in a reactive mode, and not a proactive one. This is not a healthy approach for long-term success, and as such, we can and must redirect our focus from crisis management toward identifying and implementing a strategic plan. We are all familiar with a dashboard. According to Wikipedia,1 the dashboard component of a management information system is “an easy to read, often single page, real-time user interface, showing a graphical presentation of the current status (snapshot) and historical trends of an organization’s key performance indicators to enable instantaneous and informed decisions to be made at a glance. In real-world terms, dashboard is another name for progress report or report. Often, the dashboard is displayed on a web page that is linked to a database that allows the report to be constantly updated.” We as managers and administrators should implement this concept to create an overall picture of the practice at a glance. Billing, coding, clinical care, compliance, facilities management, financial oversight, and human resources, not to mention government-mandated pro-

grams along with Meaningful Use and International Classification of Diseases, Tenth Revision, all hold a vital place on the dashboard. Who owns these key performance indicators in your office? These employees need to be identified and put into positions where their autonomy and initiative can help you achieve the practice’s overall vision.

Iris W. Nichols

You and your physician board need to define where you see the practice next month, next year, and in the next 5 to 10 years. You and your physician board need to define where you see the practice next month, next year, and in the next 5 to 10 years. Think about how you want to improve patient outcomes and satisfaction. This may be accomplished by adding physicians, expanding ancillary services, improving patient flow, scheduling efficiently, and having a person answer the phone or simply remembering to smile while working at the front desk. Look at the staff you have and determine if you have individu-

August 2014

als who understand the practice, have defined skills, and are excited to learn new ones or who are not afraid of new tasks. You need independent staff members who you can trust to perform their duties with integrity, and they should have the ability to work with autonomy. When you find these types of employees, you need to empower them to do their jobs and not micromanage them. We in management must allow these employees to be successful; however, we need to hold them accountable as they drive us to the ultimate goal of stability and success. Some of our colleagues have discovered the mechanism by which they can focus on the big picture. They have identified the core group of staff members who focus on critical “small truths.” They may have also restructured staff, updated protocols, and simplified patient flow. There are many opportunities to learn from these leaders, one of which is happening September 1213, 2014, when I and more than 100 of our colleagues will be at the National Organization of Rheumatology Managers Conference in downtown Louisville, KY. While there, you will have the ability to connect with many of your peers in the dynamics of practice management and learn their tips for success. As we come together, we can continue to learn that just getting through the day or effectively putting out fires will not work for long; for effective planning and successful practices, we must continue “to properly understand the big picture.” See you in Kentucky! l

Reference

1. Wikipedia contributors. Dashboard (management information systems). http://en.wikipedia.org/wiki/ Dashboard_(management_information_systems). Accessed July 30, 2014.

www.RheumatologyPracticeManagement.com

Practice Profile

Meeting Challenges in a...Continued from the cover

Helen E. Harmon, MD

Kyle C. Harner, MD

industry. While the city promises the conveniences of urban life, it also boasts plenty of opportunities for outdoor fun, and prosperous farmlands are a short drive away. The location of Carolina Ar thritis Center in Greenville is one of the many aspects that make it unique. Founded in 2001 by physician-sisters, the center is the only private practice, single-specialty rheumatology group in Greenville, according to Kyle C. Harner, MD, the center’s practice manager. The city is home to other rheumatologists, but they practice either in multispecialty settings or within the local medical school, the Brody School of Medicine, East Carolina University, he said. The practice has a large coverage area, serving 29 counties from Interstate 95

Robert J. Oglesby, MD

east to the North Carolina coastline, north to the state line, and south toward Wilmington. This makes their patient population di-

retired in 2010). The practice is also supported by an office administrator, an insurance team that includes 3 staff members and 1 supervisor, 3 laboratory technicians, a specialty nurse who works in the infusion suite, 3 members of the front desk staff, an x-ray technician, and 3 nurses who work in the clinic, each of whom supports one of the practice physicians. Dr Harner recently spoke with Rheumatology Practice Management about his team, the practice, and how they work together to meet challenges in the ever-changing landscape of patient care.

“We are also having to fight harder to get reimbursed, with all the insurance plans, and having to fight hard to make sure people have insurance or they are up to date on their premiums for those plans. That has been a big change.” verse, including businessmen, farmers, and retired military personnel. Dr Harner works with Robert J. Oglesby, MD, and Helen E. Harmon, MD, one of the 2 founding sisters (Betty J. Harmon, MD,

RHEUMATology Practice Management

I August 2014

Q: You have team members dedicated to insurance issues, claims processing, prior authorizations, and precertifications? Kyle C. Harner (KH): Yes. We actually have more than 1 person per doctor doing that. One person is doing mostly prior authorizations and things for infusible medicines that we give in the office. Two other full-time staff process the day-to-day claims. The one is a supervisor, too. She supervises all the personnel but is also in charge of the insurance department. It really ends up being about 4 people to do the work for 3 doctors. My role, besides being a rheumatologist, is that I am also the practice manager, which takes a little extra time for administrative duties.

Practice Profile

Q: What is your patient demographic? Are they coming from rural settings, or mostly from within the city? KH: We serve a big area. We have people coming from up to 2 or 3 hours away to see us. It is always hard to describe Greenville. It is urban, because it is a city, but I live on the edge of town, and if I go 2 miles away from town it is all tobacco and cotton and corn fields. Everything is mostly rural east of Interstate 95, other than a couple of cities. Q: How do you manage your time treating patients but also being the practice manager? KH: I consider my primary job to be seeing patients. The practice manager part comes up usually when our office manager needs help with something like Meaningful Use and making changes to prepare the system for ICD-10 [International Classification of Diseases, Tenth Revision]. I get more involved when they need clinical input. We have monthly business meetings with a consultant who comes in, and I am the lead on bringing up issues that we have and discussing things among the 3 partners. Q: What challenges has the practice faced in the last year or 2? How has the practice handled those? KH: It seems like we have to update our electronic medical records every time something changes with Meaningful Use. Going from Meaningful Use Stage 1 to Meaningful Use Stage 2 is something that we are working on right now. It changes. Every time we have to change the electronic medical records, it changes our workflow in the clinic. It does for the insurance and the front desk folks, as well. For Meaningful Use Stage 2, we are

Front desk staff: Amy Cayton (left), and Layla Tugwell.

Infusion nurse Amy Leggett.

going to have to capture a lot more data, click-the-box type of data. There is going to be a big change when that comes along. We are also having to fight harder to get reimbursed, with all the insurance plans, and having to fight

Q: You mentioned electronic record updates, transitioning from Meaningful Use Stage 1 to Meaningful Use Stage 2, and the resulting changes in workflow. How has the practice managed that? KH: We tried to come up with a plan during our monthly business meetings, but a lot of it is day-today changes to tweak things that we need to do. We rely a lot on our office administrator and also the insurance administrator to make sure that we are documenting the things that need to be documented. The front desk has to do a lot of work also, even before a patient gets in to see us, verifying information and making sure that we participate in the patientâ&#x20AC;&#x2122;s insurance plan.

â&#x20AC;&#x153;If all 3 doctors are working,...we probably see close to 100 patients in a day. They are anyone from university professors... to farmers and other people who work here in Greenville.â&#x20AC;? hard to make sure people have insurance or they are up to date on their premiums for those plans. That has been a big change. The tough part is that a lot of the costs are being shifted to the patients, and that is hard for everyone. I know it is frustrating for our insurance department to try to keep people from getting behind in payments with us. Those have been the biggest challenges.

Q: Describe your patient population. Who are they? How many are seen each day? What sorts of disorders are being treated? KH: If all 3 doctors are working, which is most days, and we are doing infusions, we probably see close to 100 patients in a day. They are anyone from university professors, because of the fairly large college here, to farmers and other people who work here in Greenville. Patients come in with rheumatoid arthritis, lupus, scleroderma, and psoriatic arthritis. Osteoarthritis and fibromyalgia are probably 2 of Continued on page 8

August 2014

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Practice Profile

Meeting Challenges in a...Continued from page 7 that patients are up to date on their payments, because if they miss payments, they are not covered; it is like not having insurance. If patients come in and they are not covered and we treat them, then either we do not get paid for the treatment, or the patient is going to get stuck with a huge bill. That is probably the biggest impact.

Laboratory staff: Mary Thompson (left), and Jill Whitley.

the most common ones we see. We do pretty much everything any other general rheumatology practice would do. Q: How has the Affordable Care Act impacted your practice from a business management perspective? KH: North Carolina really only has a few exchange plans, and they are through the federal government. They are all BlueCross BlueShield plans. As long as we can verify that patients have kept up with their monthly premiums, we have been seeing all of them. The main impact is that it is more work for the front desk to verify

Insurance department: Robin Vick (left), Rosa Robbins (center), and Megan Baker.

Q: How did your staff prepare for that change? KH: I have to give credit for that to our insurance supervisor. I know all the team members we have now are certified coders and had a lot of training dealing with these issues before we even hired them. They sat down, and between the insurance folks and the front desk folks, they came up with a standardized way of saying things

seen is that over time it seems to be more about what we document and what the insurance company wants than what is actually going on with the patient. My favorite part of going to work is sitting with the patients, but then there is the challenge of writing all the notes afterward. That is the biggest change that I have seen. I think electronic medical records are good for capturing information, but sometimes it is not necessarily the type of information that I need to take care of the patient. Q: The center has an updated electronic patient portal and FaceÂ book page. What were the benefits and challenges of developing these resources? How have they affected the practice? KH: We had an older portal that

â&#x20AC;&#x153;If patients come in and they are not covered and we treat them, then either we do not get paid for the treatment, or the patient is going to get stuck with a huge bill. That is probably the biggest impact [of the ACA].â&#x20AC;? that would not be confrontational. They came together and worked on the best ways to communicate with patients. I do not think it was easy. It also goes back to good communication skills. Q: The healthcare climate continues to change and evolve. How has your practice adapted to these changes? How has patient care changed since you first started practicing medicine? And how has practice management changed in general? KH: The biggest change I have

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did not work very well, so it has been a work in progress. The new portal is working out fairly well for the patients who want to use it. A lot of them will change appointments or ask a clinical question, and they can get advice sent back to them. The nurse will receive the clinical question, get our opinion, and message them back. I think that has been good. The challenge of it has been that, as physicians, we are not used to certain parts of the medical record being available to the patient.

Practice Profile

An example of this is laboratory results. When we look at lab work, there may be little things that are outside of the normal range. Sometimes when patients see that, especially if they are seeing it sometimes before they come back to see us the second time, they get a little concerned about things that either we were going to discuss with them or were not abnormal to the point where we were concerned about them. That may create a little bit of anxiety on the patients’ part when they see their labs before we have had a chance to discuss results with them. Regarding the Facebook page, I was at a NORM [National Organization of Rheumatology Managers] Conference 2 or 3 years ago, and there was a talk about social media and medicine. There were some attractive points to it, so when I returned, I set up a Facebook account for us. I actually manage it. I do not post many things on there, but I can tell when people are looking at it and liking the page. It also has some pictures of the clinic that patients can look at before they come, as well as some information for patients. Q: We are going into the last quarter of 2014 and starting to look toward 2015. What keeps you up at night? How do you address these concerns? KH: Our 2 big concerns right now are the EMR update that we are going to start working on, which we need to do this year. That is the one big thing, because that is going to change our workflows again as we go into the last part of this year. Also, we had a reprieve from ICD-10 for a year. We are looking forward to that next year, already trying to figure out how it is going to fit in. That

Supervisors April Bryant (left), and Glen Ballard.

is going to change a lot of things. Those are the big things, and we are trying to keep up with those as we go along. Most of that work is being done by our office administrator and the insurance administrator. I have to give them the credit for staying up at night, worrying about a lot of that. It trickles down to the physicians, too.

ferences; they always have 2 or 3 things every year that are very helpful with these changes. Also, our electronic medical record company, Centricity, has modules you can access online so you can see how the screens will look with ICD-10 and how to navigate through them. It is pretty helpful, as I think ICD-10 is going to be a

“My favorite part of going to work is sitting with the patients, but then there is the challenge of writing all the notes afterward.…I think electronic medical records are good for capturing information, but sometimes it is not necessarily the type of information that I need to take care of the patient.” Q: What sort of physician education takes place during these transition periods? KH: A lot of it has been training we can do online at our convenience. We have done some training through the NORM con-

August 2014

huge change. Once we get through this second quarter of Meaningful Use Stage 2 into 2015, we are going to be working a lot on that. We do not want to come into work on October 1, 2015, and be surprised. l

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Data Management

ACR Facilitates PQRS Compliance Efforts By Rosemary Frei, MSc

elissa Francisco of the American College of Rheumatology (ACR) does not mind taking time after regular working hours to help office managers who are confused about points of compliance with the Physician Quality Reporting System (PQRS). The head of registries at the ACR, Ms Francisco knows that part of her job means offering 24-hour support for the hundreds of ACR members’ practices who use the organization’s electronic PQRS reporting support. “I and my coworker Natalie Fisk keep very flexible hours. Physicians and their staff have crazy schedules and sometimes may need to talk to us outside of the regular workday,” Ms Francisco told Rheumatology Practice Management. “Our role is to work with ACR members whenever they need us to help them figure out how to report and the best method for them to use to report, as well as any of the details of each reporting process.” Ms Francisco and Ms Fisk help ACR members navigate electronic reporting of PQRS data, because, as the Centers for Medicare & Medicaid Services (CMS) has documented, reporting the data electronically results in a higher compliance rate. CMS is working to ensure that providers get the message that accurate reporting is important: the incentive payment for successful reporting in 2014 is 0.5%; the payment will be assessed in the fall of 2015. Beginning in 2015 there will also be a 1.5% payment adjustment to clinicians who do not satisfactorily report data on quality measures for covered professional services. This will increase to 2% in 2016. In addition, a provision came into effect this year that measures for patients with rheumatoid arthritis (RA) can no longer be reported as a

group in claims-based reporting. This will help nudge even more practices toward electronic PQRS reporting, said Ms Francisco: practices that use claims-based reporting have to report on 9 measures for 50% of patient encounters, rather than the 6 in the RA measures group that are required to be reported on by providers submitting data electronically.

“Our role is to work with ACR members whenever they need us to help them figure out how to report and the best method for them to use to report, as well as any of the details of each reporting process.” —Melissa Francisco

The 6 RA measures that are required to be reported in PQRS are as follows: documentation of which adult patients with RA have been prescribed disease-modifying antirheumatic drugs (DMARDs), as well as date and dose prescribed; whether these patients had tuberculosis screening before biologic DMARD initiation; whether patients with RA had a yearly assessment of disease activity, functional status, and disease prognosis; and which patients have been

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prescribed prednisone and whether, if they have been receiving doses of at least 10 mg daily with no change or improvement, there has been documentation of creation of a steroid management plan within 12 months. Ms Francisco gave Rheumatology Practice Management a virtual tour of the Rheumatology Clinical Registry (RCR), which was launched in 2009. The website is designed to help practice staff members easily and quickly record and correct or update annual patient information relating to the 6 RA measures. The website also automatically generates reports that show where each practice stands with respect to other rheumatology practices in reporting of the 6 measures. Ms Francisco and Ms Fisk also run 3 validation checks on each practice’s patient data, and send each practice a report that flags information that needs to be updated or corrected before the data are filed with the CMS. This service is available for a fee. ACR staff launched a new system they have dubbed RISE—Rheumatology Informatics System for Effectiveness—that pulls data for PQRS reporting directly out of electronic health records. This means the intermediary step of entering the data into the RCR will not be needed. The ACR recently attained Qualified Clinical Data Registry status for this system. “RISE is a single solution for meeting multiple reporting requirements from filing for quality-based incentive programs to avoiding penalties,” said Ms Francisco. “The ACR is committed to providing products and services designed to streamline complex reporting processes, and ultimately advance the field of rheumatology.” l

YOUR COMPLIMENTARY SUBSCRIPTION IS ONLY A CLICK AWAY Receive timely information on the latest developments in rheumatology practice Challenges of Starting a New Ancillary Service Piedmont RACTICE MANAGEMENT management to assist you in your Arthritis Clinic: A Conversation with FOR OFFICE ADMINISTRATORS, RHEUMATOLOGISTS, PHYSICIAN ASSISTANTS, PRACTITIONERS daily rolesAND andNURSE responsibilities. Nancy Ellis, MBA/MHA, Practice Administrator B Sign up now for Rheumatology Practice Management. PROCESS IMPROVEMENTS TO ENHANCE PATIENT CARE™

APRIL 2014

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VOLuME 2 • NuMBER 2

Clinic Profile

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

ased on group preferences and patients have limited options for pain state laws, rheumatology physi- control. Because of this, the 3 physicians may or may not write narcians in our practice prescribe narcotics cotic prescriptions for patients as part of for patients who we feel need long-term chronic pain management. In Eastern arthritis pain control. We have a protoNorth Carolina, primary care providers col to manage these prescriptions that is seldom write such prescriptions, and in compliance with the North Carolina outside of pain management clinics, Medical Board. FOR OFFICE ADMINISTRATORS, RHEUMATOLOGISTS, PHYSICIAN ASSISTANTS, AND NURSE PRACTITIONERS Continued on page 8 From the Editor

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

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

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

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

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Practice–Payer Relations

Potholes in the System Continued from the cover tification, or medical necessity form and submitted according to insurers’ processes, only to be turned down? After it happens time and again, it becomes important—perhaps an obligation?—to review the processes and the forms. As I have done this, I have realized that this issue of recurrent denials—an issue many of us face—may be resolved more successfully by a willingness to move beyond discussions about individual claims, join with physicians, and move toward a discussion with payers about the potholes that plague the current system. For example, there is an oral, specialty rheumatoid arthritis drug that goes through barriers to get approval for patients every time an authorization is sought. Although we submit appropriate paperwork, we must resubmit it after a denied claim, and follow up with a phone call. There are 2 or 3 questions without which the claim cannot and will not be approved, yet pharmacy benefit managers and/or the pharmacy division of some plans do not include those questions on their forms. The responsibility then becomes ours to call out this missing information in a manner that payers cannot overlook. What other steps can be taken if a manager finds a pattern of unsupported denials, or sees this as part of a larger, systemic problem in practice–payer relations? First-level appeal, second-level appeal, then a complaint to the department of insurance and the state medical society: if done expertly, these steps often work. If it becomes apparent, however, that the insur-

ance policy being appealed was designed to be cumbersome for the sake of being cumbersome, you may end up validating the time-consuming policy, inadvertently reinvigorating a destructive process.

Mark Post

When there is nothing to lose by making a formal complaint, and much to gain when the complaint is investigated, it becomes hard to justify inaction.

In this latter scenario, expanding the stage to shine a bright light on these practices for larger audiences and higher-ranking individuals such as a benefits manager can work wonders. The word gets around that

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your practice or your specialist may or will trigger processes more costly to the payer than the short-term gain of the pended money upon which they earn interest. Before escalating complaints, I try hard not to overlook effective, experienced advocates on our behalf at free benefits hotline services that many pharmaceutical manufacturers maintain for cases of unpaid and short-paid line items involving their drug or the administrative code for their drug. If these advocates get the job done, you probably will not justify the time or energy for formal, escalated complaints. It takes relatively little experience in practice management to know there is not much to gain by being nice when addressing cases of chronic claim denials. When there is nothing to lose by making a formal complaint, and much to gain when the complaint is investigated, it becomes hard to justify inaction. For those who are new to practice management or the appeals process, there is also value in reaching out to more experienced colleagues for advice or assistance. Membership in the National Organization of Rheumatology Managers also provides an essential outlet to discuss experiences and concerns. Unfortunately, there is no master document that will cover all scenarios, but perfection is not necessary to improve the current situation. Sometimes you can win even if time or facts prove you to be wrong, and, much more easily, sometimes you can lose when you are right. Neither of these outcomes should stop you from trying. l

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Physician–Hospital Alignment Series

Do’s and Don’ts in Physician–Hospital Alignment, Part 2 By Max Reiboldt, CPA, President/CEO, Coker Group, Alpharetta, GA

s today’s healthcare climate evolves, physicians and hospitals continue to explore options for alignment between private practices and healthcare systems. Interest in alignment perseveres despite a challenging healthcare environment, and economic, leadership, and structural issues should all be explored with due diligence prior to agreeing on a final arrangement. In this article, the issues of governance and compensation plans are ex plored as key elements for hospitals and physicians to consider as they work toward developing successful alignment plans.

be divided into several components. A major part of this discussion relates to operational decision-making. Often, when they align with hospitals, physicians are challenged

sion-making (discussed below), but the decisions that relate to the dayto-day management and operation of their businesses. In fact, in many instances physicians still do a better job of this than hospitals do, a premise that many hospitals are starting to concede. Thus, they are allowing One of the major physicians to have a great deal more input than they have had in the past. hurdles to overcome The structure of the alignment within any alignment model will affect the ability for operstructure is the definition ational decision-making. A professional service agreement (PSA) and understanding model, for example, allows physiof governance cians to have much decision-making ability on day-to-day operations. and leadership The issues surrounding day-to-day responsibilities. decision-making often involve staff Governance supervision, which physicians usualOne of the major hurdles to ly can handle best. Ultimately, howovercome within any alignment ever, the hospital, as the employer, is the definition and to give up day-to-day decision-mak- must have control and overall Table 1 Astructure lignment Model: Limited understanding of governance and ing responsibilities. In this instance, responsibility. leadership responsibilities. This can we are not considering clinical deciClinical decision-making is also an important part of the governance and leadership structure and definiTable 1 Alignment Model: Limited tion. While physicians certainly are allowed to practice medicine as they STRATEGY BASIC CONCEPT COMPENSATION FRAMEWORK choose (even under full employManaged Care Networks (IPAs, •Loosely formed alliances •No true impact on pay unless ment models), certain clinical deciPHOs) •Primarily for contracting through improved payer sion protocols must be considered. purposes contracts •Limited in ability unless clinically •If used as platform for ACO, For example, when a practice integrated could result in distribution of becomes a part of a large hospital •Being used as a platform for incentives received network, the implicit understanding ACO development and expectation is that they will Call Coverage Stipends •Compensation for the personal, •Payment can come in the form primarily consider referring to other financial and risk burden of a daily stipend, fee for service physicians within that aligned netassociated with ED coverage payment or hybrid payment work, although they are not legally Medical Directorships •Payment for defined •Typically paid via a market-‐ administrative services based hourly rate and contractually bound to do this. •Must be a true need for the Other clinical decision-making services should continue to rest with the Recruitment/Incubation •Traditional style of a hospital •Allows existing physicians in physicians, though the utilization of financially supporting a new practice to not see a decrease in ancillary services and rehabilitation recruit their pay as a new physician should be directed toward the comes on board aligned hospital network. There is ACO indicates accountable care organization; ED, emergency department; IPA, independent practice association; PHO, 1 absolutely no re quirement under physician hospital organization. Source: Coker Group.

Alignment Models -‐ Limited

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Physician–Hospital Alignment Series Table 2 Alignment Model: Moderate

any aligned model (Tables 1-3) for hospitals to direct physicians on how best to practice medicine. While there is much more decision-making allowance within the typical governance and leadership structures, ultimately the hospital (under a fully aligned model) should have certain reserve powers. These are usually “big picture” rights, entailing major decisions or expenditures. They could, however, be drilled down into detailed decisions, such as the hospital’s ultimate approval for any staff and for adding providers. The purpose of the reserve powers is to provide the hospital with the ultimate check and balance, knowing that under a fully aligned model it is in control of most major decisions. Under a PSA model where the practice does retain its responsibility for managing the practice, ultimately certain decisions that rest with that management structure would still be those of the practice and not subject to the reserve powers. Also, organizational chart protocols are a consideration of leadership and governance, as in the structure of the entity and how the management processes are carried out. Certain practices, for example, could be structured as a group practice subsidiary, or, if not officially and legally, this would be organized (at least in substance) as a standalone subset of the overall hospital’s employed physician network entity. Some hospitals will establish an institute model wherein the aligned practice(s) are separated into a major service line structure. Within that institute, there are individual governance, organizational, and operational understandings and protocols—again, within the definition of being a part of the overall hospital/health system organization. Many decisions must be considered within the leadership and gov-

Table 2

Alignment Models -‐ Moderate Alignment Model: Moderate STRATEGY

BASIC CONCEPT

Management Services Organization (MSO)

•Can provide an additional revenue stream

Equity Model Assimilation

•Ties all entities via legal agreements •Can jointly contract with payers •May be with a hospital partner; may be with a private group •Focus to ensure delivery of cost effective care while still maintaining quality

•Can result in increased profitability through better payer contracts and other efficiencies

Target Cost Objectives

•Joint ventures such as specialty hospitals, surgery centers, etc.

Provider Equity (Joint ventures, investments)

Clinical co-‐management/ service •Provision of administrative services and work toward certain line management strategic initiatives within a Table 3 Alignment Model: Full service line •May include pay-‐for-‐call, medical directorships, etc.

•Savings shared with providers •Percentage •Hourly fee •Fixed fee •Can provide an additional revenue stream to private practice physicians

•Involves hourly payment for administrative time and incentive payment for achieving established metrics 2

IT indicates information technology. Source: Coker Group.

Alignment Models -‐ Full

Table 3

Alignment Model: Full

STRATEGY

BASIC CONCEPT

Employment lite (“PSA model”)

COMPENSATION FRAMEWORK

•Allows practice to remain private, but hedge payer risk •Hospital owns receivables •Hospital owns payer contracts •Contract with practice for professional services

•Hospital provides payment, often on wRVU basis, which is intended to provide FMV compensation, benefits and other overhead costs incurred by practice

Employment -‐ Traditional

•Traditional employment arrangement with a hospital

•Typically includes productivity payment and potentially some other incentives for quality, cost control

Employment – Group Practice

•The larger single or multispecialty practice operates as a standalone wholly owned subsidiary of the hospital

•Entails a group income distribution plan (IDP) wherein entity dynamics remain at play

FMV indicates fair market value; PSA, professional service agreement; wRVU, work relative value unit. Source: Coker Group.

Subsidiary (GPS)

Compensation Plan Physician compensation is a major part of any transaction concerning physicians and hospitals. This does not have to be under an

employment setting, though it is often the case. If not employment, one of the fuller forms of alignment (such as a PSA) is often applicable. As such, there are several model alternatives (Tables 1-3). These vary from heavily productivity-based incentive plan models to nonproductivity-based incentives. Often and particularly as accountable care and changing reimbursement paradigms

Continued on page 16

COMPENSATION FRAMEWORK

•Services such as revenue cycle, human resources, IT, etc. •Can be hospital-‐owned, joint venture, private practice owned

August 2014

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Physician–Hospital Alignment Series

Do’s and Don’ts in Physician–Hospital…Continued from page 15 Table Leadership and and Governance Considerations Table 4 4 Leadership Governance Considerations Decision-‐Making Hospital Hospital/Practice Practice Hospital Hospital Clinical Practice Executive Board Admin Admin Admin Committee Shareholders Mgmt Com

Topic/Matter Establish PSA-‐Specific Policies Financial People/Culture Clinical Care Model Establish PSA-‐Specific Procedures Revenue Cycle Coding/Compliance Physician Scheduling Other PSA Operational Issues Payer Contracting Practice EMR System Selection and Ongoing Operations Practice Practice Management System Selection and Ongoing Operations Practice EMR/PM System Maintenance PSA Communications/Marketing Plan FD A L R/I INF

A R/I

R/I FD & L FD

R/I L

R/I R/I R/I

R/I R/I FD & L

R/I

INF FD FD

FD & L

R/I

A A

INF

R/I

FD & L

R/I

R/I FD & L L

FD & L

R/I

Final Decision Approves Leads Initiative Recommends/Provides Input Provides Information/Resource

EMR indicates electronic medical record; PM, practice management; PSA, professional service agreement. Source: Coker Group.

start to apply in many instances, the ©2014 Coker Group compensation model is truly a hybrid (ie, a combination of several of these incentives, both productivity- and nonproductivity-based). From the productivity side, the most prominent form of incentive is through a relative value unit (RVU) format. Often, RVUs are used because they are relatively easy to understand and they tend to be payer blind. Thus, physicians can work diligently within a practice and not worry about the actual reimbursement that is involved, as RVUs do not differentiate from one payer to another. Typically, their compensation plan involves being paid a certain amount per work RVU (wRVU), and as the RVUs

accumulate, the total dollars of compensation do, as well. Other productivity-based models can be tied to encounters, charges, and actual payments. There is no particular right or wrong way; it requires a concerted effort of analysis and deliberation (even some negotiations) to determine the most acceptable structure. Nonproductivity-based incentives are typically tied to patient satisfaction, quality outcomes, costsavings, and overall conduct. These incentives can be structured in a variety of ways and can be set up so that (1) productivity thresholds must be met, and (2) a portion of what would otherwise be paid from the productivity measurement

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would have to be earned through meeting certain nonproductivity-based performance thresholds. Thus, the models can have a wide range of variations, and, as long as genuine incentives to perform and meet the expectations of the criteria are present, the chances are good that the compensation model will be successful. Many employed physicians ex pect a base or guaranteed rate of pay. This is negotiable but is often the case, at least for a limited period of time. Ancillary services are also key to the compensation structure, if those services remain within the practice after alignment. If they do, the physician may be able to share in a

Physician–Hospital Alignment Series

portion of the profits from those ancillary services (just as they do today in private practice). If not, the ancillary services cannot be paid to the physicians and may be a reason why overall productivity and profit margins are less after the transaction. There are ways to mitigate this issue through calibrating an appropriate rate per wRVU that is still within legally permissible/fair market value parameters, but possibly better than the practice realizes in actuality prior to the alignment transaction. Quality and shared savings incentives are increasingly popular as accountable care forms of reimbursement (ie, reimbursement that is not based strictly on productivity and a fee-for-service payment) gain ground. Realizing that it is impor tant to measure overall performance based on the quality of the outcomes and the cost to incur the services, more compensation plans are mirroring these forms of reimbursement, which is certain to continue to be the case in the future. Finally, here is a word of caution relative to the overall compliance standards that must be met whenever physicians are compensated by a hospital. The term fair market value is a readily used concept, which entails the determination that the rate of compensation is consistent with market standards and norms. This is often reviewed and opined upon by an expert independent party that is not directly involved in establishing the rates or the overall compensation plan. In addition, compensation must meet existing commercially reasonable standards within the particular area and specialty involved. Also, there are many compensation structures

where multiple portals of pay are provided to the physicians. For example, perhaps the physician is employed and generates a compensation structure from that employment contract. In addition, he is subject to a medical directorship and is compensated. Perhaps the physician is also compensated for call responsibilities. All of these

Max Reiboldt

Many decisions must be considered within the leadership and governance structure as the alignment process unfolds. We recommend that a checklist of all the key derivatives be considered. things must be considered within the compliance standard so this stacking concept does not ultimately result in a total pay package that

is beyond the realm of reason (ie, that exceeds the test for fair market value/commercially reasonable rates). Thus, when the compensation plan is structured, it should be considered in totality, not just as stand-alone components. Thus, there are numerous models to consider—no matter the alignment model. Even within a PSA structure (also referred to as employment “lite”), the payments can be varied and tied to certain levels of incentives. There are other forms of compensation, such as payment for malpractice premiums or tail premiums, sign-on and/ or retention bonuses, and other forms of pay—all of which must be considered in the broad context of physician compensation. For models that do not entail employment or other forms of full alignment, the pay structure is frequently set with fewer incentives (though some incentives could be in place within these structures). Often, a guaranteed rate per hour is applied, but that payment must be consistent with the total amount of time worked and the value for that work per hour. Usually, this varies greatly from one specialty to another. l This article is the second in a 3-part series addressing physician–hospital alignments. Part 1 focused on pretransactional due diligence and structural design processes as they pertain to these alignments. Part 2 of this series is focused on governance and compensation plans. Watch for the final installment of this series— highlighting ongoing relationships and unwind possibilities—in the October issue.

SAVE THE DATE This year’s NORM conference will be held September 12-13, 2014, in Louisville, KY—see page 2 in this issue for more information.

August 2014

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Patient Education

The Impact of Patient Education on Disease Outcomes By Deanna L. Owens, RN, MSN Director of Infusion & Clinical Services, Low Country Rheumatology, Charleston, SC; and Historian, Rheumatology Nurses Society

atients with rheumatic, immune- mediated, inflammatory diseases require extensive and ongoing assessments of their disease state in response to treatment, providing opportunities for nurse–patient education. Evolution of healthcare has led from treatment on an acute-care basis to patients receiving comprehensive care of their chronic condition in a specialized clinic. The growth of rheumatology as a specialty led to the recent publication of Rheumatology Nursing: Scope and Standards of Practice developed by the Rheumatology Nurses Society (RNS).1 The rheumatology registered nurse provides individualized care through in-depth health assessments, medication monitoring, and patient education related to rheumatic disease.

Rheumatology registered nurses are integral in providing education during office visits, ensuring that patients understand the value of their compliance in the effectiveness of their treatment plan. Treatment for rheumatic disease is aimed at managing symptoms to prevent disease progression and damage while improving the

KEY POINTS Patients with rheumatic diseases require ongoing assessments of their disease state in response to treatment; this provides opportunities for nurse–patient education.

➤

By identifying individual patient needs, education from a rheumatology registered nurse increases patient compliance and improves disease outcomes.

➤

Developing a nursing plan that is focused on patients’ understanding of their disease is critical to foster participation and facilitate adherence to their treatment plan.

➤

Varying levels of patient education and cultural background must be taken into consideration when working to foster patient understanding and adherence.

➤

Successful treatment of autoimmune disorders requires a multilayered approach that integrates the knowledge of the rheumatology registered nurse and a tailored educational plan to increase patient compliance and improve outcomes.

➤

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patient’s overall quality of life. By identifying the needs of an individual patient, education from a rheumatology registered nurse increases patient compliance and improves disease outcomes.

Patient Education Leads to Compliance With compliance in mind, developing a nursing plan focused on patients’ understanding of their disease is critical to foster participation and facilitate adherence to their treatment plan. It is necessary to properly assess the multiple learning needs of each individual to accurately balance what the patient wants to know versus what they need to know. Patients are typically concerned with treatment options, medication side effects, and quality of life, while healthcare providers often concentrate on safety, prevention of disease progression, and treatment plan adherence. The rheumatology registered nurse uses evidence-based knowledge to bridge the gap between patient concerns and provider focus, thus empowering patients to engage in individualized discussions, understand written materials, and participate in behavioral change counseling. To facilitate this dialogue, the varying levels of patient educational and cultural background must be taken into consideration, using both existing resources and developing new tools as necessary. A qualitative study revealed that nurses who provide medication information resulted in patients feeling in control and

Patient Education

“described the importance of being involved in decisions about their medication,” leading to enhanced adherence.2 Tailoring instructions specifically to the individual creates a sense of security that contributes to the patient’s overall confidence and self-awareness necessary to comprehend disease management.

Patient Compliance Leads to Improved Outcomes Autoimmune diseases are often unpredictable, requiring continuous follow-up visits, and ongoing monitoring of various labs and disease activity scores. Recurring visits to an outpatient specialty clinic provide exposure to necessary resources, enhancing patients’ knowledge about their disease activity and treatment goals. Rheumatology registered nurses are integral in providing education during office visits, ensuring that patients understand the value of their compliance in the effectiveness of their treatment plan. A systematic review of 63 studies that focused on the impact of educational intervention in the rheumatoid arthritis population revealed positive short-term effects of patient education targets for patients with rheumatoid arthritis.3 Although long-term effects of patient education were inconclusive, the shortterm benefits demonstrated in the study provide a solid foundation to continue the development of quality patient resources. In another review, multiple studies involving nurse-led rheumatology clinics found that patient knowledge and satisfaction increased while pain

and fatigue decreased.4 Furthermore, a 2013 study by Ndosi and colleagues showed that patients receiving nurse-led care achieved better disease activity scores compared with patients receiving rheumatol-

The level of education and counseling required to achieve improved patient outcomes highlights the importance of creating an organized team of healthcare providers dedicated to becoming a valuable resource. ogist-led care.5 In addition, nurseled care provided patient education more frequently than did rheumatology-led care.5 The authors’ findings further solidify the importance of the rheumatology registered nurse’s role in improving patient outcomes by providing valuable education.

Benefits of Continued Education for the Healthcare Team Successful treatment of complex autoimmune disorders requires a

multilayered approach that integrates the expert knowledge of the rheumatology registered nurse and a tailored educational plan to increase patient compliance and improve outcomes. Although additional research is needed in this area, the benefits of nurse–patient educational interventions are clear. The goal of treatment is adequate disease management, and patients experiencing symptomatic relief and increased quality of life will also result in additional referrals and recognition of the practice as a leader in the treatment of rheumatic disease. The level of education and counseling required to achieve improved patient outcomes highlights the importance of creating an organized team of healthcare providers dedicated to becoming a valuable resource. Through support from professional organizations like the RNS, rheumatology registered nurses are provided continued education opportunities to expand their evidence-based knowledge––benefiting patients, their families, and the community. l

References

1. The Rheumatology Nurses Society. Rheumatology Nursing: Scope and Standards of Practice. http:// rnsnurse.org/product/rheumatology-nursing-scopeand-standards-practice. Accessed May 20, 2014. 2. Larsson I, Arvidsson S, Bergman S, Arvidsson B. Patients’ perceptions of drug information given by a rheumatology nurse: a phenomenographic study. Musculoskeletal Care. 2010;8:36-45. 3. Niedermann K, Fransen J, Knols R, Uebelhard D. Gap between short- and long-term effects of patient education in rheumatoid arthritis: a systematic review. Arthritis Rheum. 2004;51:388-398. 4. Hill J, Thorpe R, Bird H, et al. Outcomes for patients with RA: a rheumatology nurse practitioner clinic compared to standard outpatient care. Musculoskeletal Care. 2003;1:5-20. 5. Ndosi M, Lewis M, Hale C, et al. The outcome and cost-effectiveness of nurse-led care in people with rheumatoid arthritis: a multicentre randomised controlled trial. Ann Rheum Dis. 2013 Aug 27. Epub ahead of print.

Rheumatology Practice Management is now available online at: www.RheumatologyPracticeManagement.com

August 2014

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Best Practices

Ceasing All RA Medications Not Optimal in Patients Trying to Conceive How to manage your pregnant patients with inflammatory RA By E. K. Charles

Charlotte, NC—Although managing rheumatoid arthritis (RA) in patients who are pregnant or trying to conceive may be challenging, rheumatologists should aim to improve disease activity and pregnancy outcomes, according to Megan E. B. Clowse, MD, MPH, Associate Professor of Medicine, Director, Duke Autoimmunity in Pregnancy Registry, Duke University Medical Center, at the North Carolina Regional Association 2014 annual meeting. “I really have seen from both data and personal experience that stopping all medications in a rheumatoid arthritis patient when she wants to conceive is really the wrong thing to do,” Dr Clowse emphasized at the beginning of her talk. “What we see are patients flaring, not getting pregnant, and having a lot of difficulty during their pregnancies.” Treating these patients with prednisone when they flare after all medication has been stopped is not the best approach, she added. Most patients with RA get better,

Dr Clowse explained, citing previous research, with 77% of patients going into remission during pregnancy and 81% of patients relapsing during the first 3 months after delivery. “Patients who are on TNF [tumor necrosis factor]-inhibitors,

The investigators found that increased disease activity was associated with lower birth weight, and increased prednisone use was associated with shorter gestational age.

stop them, and then get pregnant, are never doing as well as they did when they were on their TNFinhibitor,” Dr Clowse added.

KEY POINTS When caring for pregnant patients, rheumatologists should aim to improve disease activity and pregnancy outcomes.

➤

Pregnancy outcomes in patients with RA are good overall.

➤

Disease activity early in pregnancy is correlated with pregnancy outcomes.

➤

Prednisone use is not optimal in this patient population; rheumatologists may consider using hydroxychloroquine and sulfasalazine.

➤

Does RA Activity Impact Pregnancy Outcomes? Pregnancy outcomes in patients with RA are good overall, Dr Clowse stated, citing previously published data. In particular, the risk of preterm delivery increases approximately 30% in patients with RA, and preeclampsia is increased by approximately 75% in patients with RA compared with the general population. “But I think that what we need to determine is who is actually going to have those problems, as opposed to what the overall rates are,” Dr Clowse noted. Growing evidence indicates that RA impacts pregnancy outcomes, she continued. In the Pregnancy-Induced Amelioration of Rheumatoid Arthritis study, 81 prospective pregnancies were evaluated. The investigators found that increased disease activity was associated with lower birth weight, and increased prednisone use was associated with shorter gestational age. Results from another study by Chakravarty and colleagues, which evaluated 42 retrospective pregnancies, found that there was no change in pregnancy outcomes with RA activity; patients who stopped taking their RA medication tended to have earlier delivery. The Duke Autoimmunity in Pregnancy Registry, which was started in 2008, has approximately 230 patients with various rheumatic disorders. Overall, approximately half of the women included in the registry were diagnosed with systemic lupus erythematosus; other diagnoses included RA, other Continued on page 22

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Call for submissions

Do you have a practice management solution to share

FOR OFFICE ADMINISTRATORS, RHEUMATOLOGISTS, PHYSICIAN ASSISTANTS, AND NURSE PRACTITIONERS

In your background as a rheumatology practice manager, it’s likely there’s one business experience—and maybe more—that practice managers across the nation would want to read about. High-interest topics include: the solution you found to a practice management challenge, reimbursement, your experience with EMR, Medicare audits, a memorable encounter that shaped the way you now run your business and/or practice medicine, or how you successfully integrated ancillary products and services into your practice as a revenue generator.

Send us your ideas!

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

E-Mail to: acooper@the-lynx-group.com RPMsubmissions_61014

Best Practices

Ceasing All RA Medications Not Optimal...Continued from page 20 inflammatory arthritis, and Ro antibody-positive. “What we found was that disease activity in the early part of pregnancy correlated highly with pregnancy outcomes,” Dr Clowse explained, citing results from the prospective cohort study. “In particular, with timing of the delivery.” All of the patients with preterm births had moderate-to-severe disease activity in the first and second trimesters compared with patients who delivered full-term. Only 1 patient who delivered fullterm had moderate-to-severe disease activity, she noted.

Treating Pregnant Patients with RA The goal is to improve RA activity and improve pregnancy outcomes, Dr Clowse stated. Unfortunately, prednisone therapy has adverse events associated with its use, she explained. In particular, data have shown that prednisone is associated with a 3-fold increase in the occurrence of cleft lip or palate and long-term neurocognitive changes in the offspring of patients taking the drug. Increased preterm birth, preeclampsia, gestational diabetes, maternal hypertension, and excessive weight gain have also been observed. “There are other really good options that I really want you to think about when a patient comes in and is sitting in front of you,” Dr Clowse continued. These include hydroxychloroquine and sulfasalazine. The former has some effect on mild arthritis and is a pregnancy Category C drug, with no human toxicity reports. The latter has shown good efficacy for peripheral arthritis and is a pregnancy Category B drug with a good safety profile in pregnancy. Both methotrexate and leflun-

omide are classified as pregnancy Category X and are not good options for pregnant patients with RA. Data indicate a 25% to 50% risk for pregnancy loss and a 10% risk for congenital anomalies associated with methotrexate.

Patients taking prednisone had a high level of disease activity, with 54.4% resulting in abnormal outcomes, and patients taking anti-TNF inhibitors also had a high level of disease activity, with 14.3% resulting in abnormal outcomes.

Although human data are reassuring for the use of leflunomide, the pregnancy profile is terrible in animals. “I would certainly not recommend that anybody get pregnant on leflunomide, but I also would never recommend a termination, particularly without any evidence of anomalies,” she stated. If the patient’s obstetrician insists on a pregnancy termination, Dr Clowse suggested recommending the patient get a second opinion. TNF inhibitors, as well as all antibodies, can transfer across the placenta and that transfer increases as patients get closer to term. If the patient is taking immunoglobulin-based med ications, there will be a significant amount of transfer during the time of delivery, she explained. Taking a closer look at

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specific TNF inhibitors, infliximab and adalimumab levels are higher in the cord blood serum than in maternal serum levels, while etanercept and certolizumab levels are lower in the infant than they are in the mother. Overall, the pregnancy outcomes of patients taking TNF inhibitors are not worrisome for the most part, according to Dr Clowse. Results from a 2009 review by Vinet and colleagues indicated that pregnancy outcomes are similar among pregnant patients taking TNF inhibitors and the general US population: live-birth rates (76%), miscarriage rate (13%), termination rate (11%), and rate of congenital abnormalities (3%). “Infants who are exposed to TNFinhibitors, particularly toward the end of term, may have immunosuppression,” Dr Clowse emphasized. “These babies should not get live vaccines in the first 5 months of life.” The only live vaccine given to infants before 1 year of age in the United States is rotavirus. Investigators using data from the Duke Autoimmunity in Pregnancy Registry evaluated whether TNFinhibitors may improve pregnancy outcomes in RA. Patients were divided based on the medication they were taking during the first trimester. Overall, 11 patients were taking prednisone, 7 were taking anti-TNF inhibitors, and 11 were taking neither drugs. Patients taking prednisone had a high level of disease activity, with 54.4% resulting in abnormal outcomes, and patients taking anti-TNF inhibitors also had a high level of disease activity, with 14.3% resulting in abnormal outcomes. Patients who did not take either drug, however, had a low level of disease activity and no abnormal outcomes. l

Wealth Management

New IRA Rollover Rules Issued by the IRS By Lawrence B. Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF

he Internal Revenue Service (IRS) recently issued an announcement clarifying individual retirement account (IRA) rollover rules. This change in the position stated in IRS Publication 590, Individual Retirement Ar rangements, may have an impact on you and how you manage your retirement accounts. As such, the IRS will be rewriting IRS Publication 590 to reflect this change. According to the announcement, it will not be effective before January 1, 2015.

IRS Reverses Long-Standing Position The Internal Revenue Code currently states that if you receive a distribution from an IRA, you cannot make a tax-free rollover into another IRA if you’ve already completed a tax-free rollover within the previous 12 months. Let’s first look at the definition of a rollover. A rollover is a transaction where the taxpayer takes constructive receipt of funds from an IRA (other than a SIMPLE IRA in the first 2 years of participation) and then has a maximum of 60 days to put the funds back into an IRA (the same or a different IRA) in order to avoid a taxable distribution. It is important to note that a rollover from an IRA can also be deposited into a qualified plan within the 60-day limit to avoid taxation. It is also important to point out that a rollover from a Roth IRA may generally be made only to another Roth IRA. Rollovers are different than a direct transfer, where the funds are transferred as a trustee-to-trustee transfer and are transferred directly between the custodians/trustees of the IRAs or employer-sponsored plans involved. The number of direct

transfers is unlimited in any particular time period. The long-standing position of the IRS, reflected in Publication 590 and proposed regulations, has been that this rule applies separately to each IRA you own. Publication 590 provides the following example: “You have two traditional IRAs, IRA-1 and IRA-2. You make a taxfree rollover of a distribution from IRA-1 into a new traditional IRA (IRA-3). You cannot, within 1 year of the distribution from IRA-1, make a tax-free rollover of any distribution from either IRA-1 or IRA-3 into another traditional IRA. However, the rollover from IRA-1 into IRA-3 does not prevent you from making a tax-free rollover from IRA-2 into any other traditional IRA. This is because you have not, within the last year, rolled over, tax free, any distribution from IRA-2 or made a tax-free rollover into IRA-2.” The change in the IRS position is that the 1-rollover-per-year rule is now going to apply on a taxpayer basis, rather than on an IRA basis. This follows a recent tax court decision case (Bobrow v Commissioner), where the court held that the 1rollover-per-year rule applies to all of a taxpayer’s IRAs in the aggregate, and not to each IRA separately.

Bobrow v Commissioner In this case, Mr Bobrow (a tax attorney) did the following: • On April 14, 2008, he withdrew $65,064 from IRA-1. On June 10, 2008, he repaid the full amount into IRA-1 • On June 6, 2008, he withdrew $65,064 from IRA-2. On August 4, 2008, he repaid the full amount into IRA-2. Mr Bobrow completed each roll-

August 2014

over within 60 days. He made only 1 rollover from each IRA. Lawrence B. Keller So, according to Publication 590 and the proposed regulations, this should not have been an issue. However, the IRS served Mr Bobrow with a tax deficiency notice, and the case went to tax court. The IRS argued to the court that Mr Bobrow violated the 1-rollover-per-year rule. The tax court agreed with the IRS, relying on its previous rulings, the language of the statute, and the legislative history. The court held that regardless of how many IRAs he or she maintains, a taxpayer may make only 1 nontaxable rollover within each 12-month period.

What This Means For the rest of this year, the old 1-rollover-per-year rule in IRS Publication 590 will apply to any IRA distributions you receive. So if you have a need to use 60-day rollovers to move funds between IRAs, you have only a limited time to do so without regard to the new Bobrow interpretation. Summary A rollover transaction should only be considered in limited circumstances where there is an actual need for the funds for a short period of time, and it is expected that the entire amount of funds distributed are to be repaid within 60 days. Otherwise, a direct transfer should be the transaction of choice. 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 e-mail to Lkeller@physicianfinancialservices.com with comments or questions.

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C. Harne Arthritis Cente r, MD, Managing Partn er, Carolina r, Greenville, NC ased on group preferences and state laws, rheum atology physi- patients have limited option cians may or s for pain control. Becau se of this, the cotic prescription may not write narcians 3 physis for patients chronic pain as part of for in our practice prescribe narcot management. patients who In North Caroli we feel need long-t ics na, primary care Eastern arthritis pain erm control. seldom write providers col FOR OFFICE such prescription to manage these We have a protoADMINISTR s, and in compl prescriptions ATORS, RHEU outside of pain that is MATOLOGISTS, management clinics iance , Medical Board with the North Carolina PHYSICIAN ASSISTANT .

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ancy Ellis’ day morning walk starts with a office to greet around the colleagues and get a feel for pressin The administrato g issues of the day. r of a busy rheum ogy practice, atolMs of the 26 people Ellis may run into any who work at Piedm ont Continued on page

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By Iris W. Nicho ls, President, Managers; National Orga Editor-in-Ch nization for ief, Rheumato Rheumatology logy Practice Manageme e are all aware nt of the many challenges and opportunities mance indicators that exami we face in tice quality rheum as well as costs, ne pracpractices. As atology evalua we and we te our practi articles, news see from the countless ces by compa them to yester blurbs, and listser ring day, ings, we all encounter simila v post- exist today, and looking at how they We strive for preparing them r things. morro for tow. I recently (our physicians quality improvement returned from meeting where are known to a we be in this area), we have ongoin leaders together to meet discussed partnering g perfor- I these challenges. outlined my thoughts to prepar As e for

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Otezla SupportPlus Offers Comprehensive Patient Assistance The information below, provided by Celgene, highlights assistance options for patients who have been prescribed Otezla.

rect the Otezla prescription to the appropriate contracted specialty pharmacy. The Otezla network of contracted specialty pharmacies provides patients and healthcare providers with prior authorization support and ongoing treatment expertise. Celgene has partnered with approximately 40 specialty pharma-

An illustration of joints affected by psoriatic arthritis.

cies to ensure that patients have access to a wide network of specialty pharmacy options. Otezla SupportPlus also coordinates financial support for patients

Celgene aims to provide patients who are prescribed Otezla a positive product experience through specialty pharmacy partnerships, 501(c)(3) foundation support, educational materials, and Otezla SupportPlus, a comprehensive patient assistance program.

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elgene is a global biopharmaceutical company committed to improving the lives of patients worldwide, seeking to deliver innovative and life-changing treatments. As part of this commitment, the company aims to provide patients who are prescribed Otezla a positive product experience through specialty pharmacy partnerships, 501(c)(3) foundation support, educational materials, and Otezla SupportPlus, a comprehensive patient assistance program. Otezla SupportPlus was designed to serve as a safety net for patients who experience product access challenges. Reimbursement advocates are available Monday through Friday, from 8 am to 8 pm EST by calling 844-4OTEZLA (844-4683952). These advocates will help

patients gain access to Otezla by assisting with the following: benefits counseling, appeal support after coverage denial, and, most importantly, to confirm coverage and di-

RHEUMATology Practice Management

I August 2014

who encounter high out-of-pocket costs for their Otezla prescription. The Otezla Savings Program was developed for commercially insured patients and, if eligible, the patientâ&#x20AC;&#x2122;s copay contribution may be reduced to $0. In addition, eligible Medicare patients can obtain financial assistance through the Patient Access Network Foundation, which offers an annual grant of $3800. Patients who do not have prescription coverage or who are deemed underinsured may be eligible to receive Otezla free of charge. Otezla SupportPlus will refer and/or assist a patient through the enrollment process for each financial assistance option, depending on the patientâ&#x20AC;&#x2122;s unique situation. Otezla SupportPlus has additional resources available for patients and healthcare providers, including 24-hour nurse support as well as educational and adherence programs. Contact Otezla SupportPlus at 844-4OTEZLA (844-468-3952) or visit www.otezla.com to learn more. l

Drug Update

Otezla (Apremilast), an Oral PDE-4 Inhibitor, Receives FDA Approval for the Treatment of Patients with Active Psoriatic Arthritis By Loretta Fala, Medical Writer

soriatic arthritis, a progressive, potentially debilitating type of arthritic inflammation, affects approximately 7 million people in the United States.1,2 An estimated 15% to 30% of patients with psoriasis will develop psoriatic arthritis.1,3 Psoriasis, a chronic, relapsing disease characterized by thick patches of inflamed, scaly skin resulting from excessive proliferation of skin cells, affects up to 2.6% of people in the United States.2 Both psoriatic arthritis and psoriasis are chronic autoimmune diseases.1 The symptoms of psoriatic arthritis, like the symptoms of psoriasis, may flare and subside, varying from person to person.3 In some cases, the arthritis precedes skin disorders. Psoriatic arthritis can affect any joint in the body; it may affect 1 or more joints (eg, 1 or both knees), and it may affect fingers and toes.3 Some patients also develop dactylitis, a condition in which the fingers and toes swell profusely.3 Many patients with psoriatic arthritis are affected by the joint disease and the psoriasis that often accompanies it.4 Psoriatic arthritis affects women and men equally.5 Although it generally develops between the ages of 30 years and 50 years, psoriatic arthritis can also start in childhood.3 An estimated 40% of patients with psoriatic arthritis have a family member with the disease, suggesting that heredity may play a key role. Psoriatic arthritis may also be triggered by an infection, including a streptococcal throat infection.3

The chronic pain, fatigue, limitations in physical function, and work disability associated with psoriatic arthritis can have a profound effect on the patient’s health-related quality of life.6 Furthermore, the risk for cardiovascular disease and other comorbidities is greater in patients with psoriatic arthritis and other inflammatory diseases than in individuals without these diseases.2,4

“Relief of pain and inflammation and improving physical function are important treatment goals for patients with active psoriatic arthritis. Otezla provides a new treatment option for patients suffering from this disease.” —Curtis Rosebraugh, MD, MPH

Psoriatic arthritis can also have a substantial impact on a patient’s psychological well-being, because of the itching, pain, and potential for social rejection encountered by many patients.2,4 Psoriatic arthritis imposes a considerable economic burden on patients and society. Based on a 2010 review of the literature, in the United States, direct annual med-

ical costs associated with psoriatic arthritis total nearly $1.9 billion.4 In this review of 49 studies, patients with psoriatic arthritis had a lower health-related quality of life compared with the general population.4 Moreover, the direct and indirect costs associated with psoriatic arthritis, including lost productivity and disability, increase with worsening disease activity (ie, joint involvement and psoriatic skin lesions) and worsening physical function.4 Evidence shows that persistent inflammation associated with psori atic arthritis causes joint damage over time. Consequently, early diagnosis of psoriatic arthritis is essential, because early detection and treatment may prevent further damage to the joints.3 The therapeutic goals for patients with psoriatic arthritis are to alleviate symptoms, control inflammation in affected joints, and prevent joint pain and disability.7 Treatment depends on the severity of the disease, the number of joints involved, and the associated skin symptoms.1 During the early stages of psoriatic arthritis, nonsteroidal anti-inflammatory drugs (NSAIDs) and cortisone may be used to manage mild inflammation. For patients with erosive disease or for those in whom NSAIDs fail to work, the disease-modifying antirheumatic drugs (DMARDs), including methotrexate, sulfasalazine, leflunomide, and a number of biologic agents may be used to slow the progression of psoriatic arthritis and spare the joints and other tissues from permanent damage.1,7 Until recently, the US Food and Drug Administration (FDA)Continued on page 28

August 2014

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Drug Update

Otezla (Apremilast), an Oral PDE-4 Inhibitor...Continued from page 27 Table 1. Apremilast Dosage Titration Schedule for Patients with Psoriatic Arthritis Day 1

Day 2

am 10 mg

Day 3

Day 4

Day 5

Day 6 and thereafter

10 mg

20 mg

30 mg

Source: Otezla (apremilast) tablets prescribing information; March 2014.

approved treatments for psoriatic arthritis included corticosteroids, several tumor necrosis factor blockers, and an interleukin-12/interleukin-23 inhibitor.8

A Novel Oral Therapeutic Option for Psoriatic Arthritis On March 21, 2014, the FDA approved apremilast (Otezla; Celgene) for the treatment of adults with active psoriatic arthritis. An oral inhibitor of phosphodiesterase (PDE)-4, apremilast is the first oral therapy to receive FDA approval for the treatment of adult patients with active psoriatic arthritis.8 According to Curtis Rosebraugh, MD, MPH, Director of the Office of Drug Evaluation II at the FDA Center for Drug Evaluation and Research, “Relief of pain and inflammation and improving physical function are important treatment goals for patients with active psoriatic arthritis. Otezla provides a new treatment option for patients suffering from this disease.”8 Mechanism of Action Apremilast is a small-molecule inhibitor of PDE-4 specific for cyclic aden osine monophosphate (cAMP). Inhibition of PDE-4 results in increased intracellular cAMP levels. The specific mechanism by which apremilast exerts its therapeutic effect in patients with psoriatic arthritis is not well defined.9 Dosing and Administration To reduce the risk of gastrointestinal symptoms, it is recommended

that apremilast is titrated to the recommended dose of 30 mg twice daily, to be taken orally starting on day 6. The recommended initial dosage titration of apremilast from day 1 to day 5 is shown in Table 1.9 Coadministration of apremilast with food does not alter the extent of absorption of this drug.9 The recommended dose for patients with severe renal impairment is 30 mg once daily. For initial dose titration in these patients, titration should follow the morning schedule in Table 1; the afternoon doses should be skipped.9 Apremilast is available in 10-mg, 20-mg, and 30-mg tablets.9

Clinical Trials The safety and efficacy of apremilast were demonstrated in 3 multicenter, randomized, double-blind, placebocontrolled trials of similar design.9 In these studies (ie, PsA-1, PsA-2, PsA3), a total of 1493 adult patients with active psoriatic arthritis (≥3 swollen joints and ≥3 tender joints) despite previous or current treatment with DMARD therapy were randomized to receive placebo, apremilast 20 mg twice daily, or apremilast 30 mg twice daily.9 Enrolled patients had a diagnosis of psoriatic arthritis for at least 6 months. The primary end point was the percentage of patients who achieved American College of Rheumatology (ACR)20 response at week 16.9 An ACR20 is defined as a 20% improvement in tender and swollen joint counts and a 20% improvement in 3 of the 5 remaining ACR core set

RHEUMATology Practice Management

I August 2014

measures (ie, patient and physician global assessments, pain, disability, others).10 An ACR50 represents a 50% improvement in both measures; an ACR70, a 70% improvement in both measures.10 In these studies, placebo-controlled efficacy data were also collected and analyzed through week 24. If patients’ tender and swollen joint counts had not improved by at least 20%, they were considered nonresponders at week 16. Placebo nonresponders were rerandomized 1:1 in a blind fashion to either apremilast 20 mg twice daily or 30 mg twice daily, after titration. Patients receiving apremilast continued their initial treatment. At week 24, all remaining patients receiving placebo were rerandomized to either 20 mg twice daily or to 30 mg twice daily.9 Patients enrolled across the 3 clinical studies had a median duration of psoriatic arthritis disease of 5 years, with a variety of psoriatic arthritis subtypes, including symmetric polyarthritis (62%), asymmetric oligoarthritis (27%), distal interphalangeal joint arthritis (6%), arthritis mutilans (3%), and predominant spondylitis (2.1%). Patients received concomitant therapy with at least 1 DMARD (65%), methotrexate (55%), sulfasalazine (9%), leflunomide (7%), low-dose oral corticosteroids (14%), and NSAIDs (71%). Previous treatment with small-molecule DMARDs was reported in only 76% of patients, and previous treatment with biologic DMARDs was reported in 22% of patients, including

Drug Update

Table 2. Apremilast versus Placebo: Proportion of Patients with Psoriatic Arthritis and ACR Response at Week 16 PsA-1 study

PsA-2 study

Placebo ± DMARDs (N = 168)

Apremilast 30 mg twice daily ± DMARDs (N = 168)

ACR20, %

ACR50, % ACR70, %

Patients with ACR response at week 16

PsA-3 study

Placebo ± DMARDs (N = 159)

Apremilast 30 mg twice daily ± DMARDs (N = 162)

Placebo ± DMARDs (N = 169)

Apremilast 30 mg twice daily ± DMARDs (N = 167)

38a

32a

41a

Significantly different from placebo (P <.05). ACR indicates American College of Rheumatology; DMARD, disease-modifying antirheumatic drug; PsA, psoriatic arthritis. Source: Otezla (apremilast) tablets prescribing information; March 2014.

9% who failed previous biologic DMARD treatment.9 The proportion of patients who achieved a clinical response (ie, ACR20, ACR50, or ACR70 responses) in studies PsA-1, PsA-2, and PsA-3 are shown in Table 2. Patients receiving apremilast ± DMARDs showed greater reductions in signs and symptoms of psoriatic arthritis compared with placebo ± DMARDs as demonstrated by the proportion of patients who achieved an ACR20 response at week 16.9 Apremilast 30 mg twice daily also demonstrated improvement for each ACR component versus placebo at week 16 in study PsA-1, as shown in Table 3. These results from study PsA-1 were consistent with those observed in studies PsA-2 and PsA-3. In study PsA-1, apremilast 30 mg twice daily also showed a greater improvement in mean change from baseline for the health assessment questionnaire disability index (HAQ-DI) score at week 16 compared with the placebo group. The proportions of HAQ-DI responders (≥0.3 improvement from baseline) at week 16 were 38% for the apremilast (30 mg twice daily) group compared with 27% for the placebo group.

Consistent results were observed in studies PsA-2 and PsA-3.9

Safety The most common adverse reactions associated with apremilast occurring in ≥5% of patients were nausea (8.3%), diarrhea (7.7%), and headache (5.9%). In addition, upper respiratory tract infections were reported in 3.9% of patients and vomiting in 3.2%.9 Similarly, the most common reasons leading to treatment discontinuation with apremilast were diarrhea (1.8%), nausea (1.8%), and headache (1.2%). In clinical trials, the proportion of patients with psoriatic arthritis who discontinued treatment because of any adverse reaction was 4.6% for patients taking apremilast 30 mg twice daily and 1.2% for patients receiving placebo.9 Warnings and Precautions Contraindications. Apremilast is contraindicated in patients with a known hypersensitivity to apremilast or any of the excipients in the formulation.9 Drug interactions. Use of apremilast with strong cytochrome P450 enzyme inducers (eg, rifampin, phe-

nobarbital, carbamazepine, phenytoin) is not recommended, because it may result in a loss of efficacy of apremilast.9 Depression. Patients should be advised of the potential emergence or worsening of depression, suicidal thoughts, or other mood changes. The risks and benefits of treatment with apremilast should be weighed carefully in patients with a history of depression and/or suicidal thoughts or behavior.9 Weight decrease. The patient’s weight should be monitored regularly. If unexplained or clinically significant weight loss occurs, discontinuation of apremilast should be considered.9

Use in Specific Populations Pregnancy. Adequate and wellcontrolled studies with apremilast have not been conducted in pregnant women. Apremilast should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.9 Nursing mothers. It is not known whether apremilast or its metabolites are present in human milk. However, because many drugs are present in human milk, caution should be exercised when apremilast Continued on page 30

August 2014

www.RheumatologyPracticeManagement.com

Drug Update

Otezla (Apremilast), an Oral PDE-4 Inhibitor...Continued from page 29 is administered to a nursing woman.9 Severe renal impairment. Increased

systemic exposure of apremilast has been observed in patients with severe

Table 3. Study PsA-1 of Patients with Psoriatic Arthritis: Mean Change in ACR Components from Baseline with Apremilast, at Week 16 Placebo Apremilast 30 mg ACR component (N = 168) twice daily (N = 168) Number of tender jointsa Sample size, N 166 164 a 23 23 Baseline –2 –7 Mean change at week 16b c Number of swollen joints Sample size, N 166 164 13 13 Baselinec b –2 –5 Mean change at week 16 d Patient’s assessment of pain (VAS) Sample size, N 165 159 d 61 58 Baseline b –6 –14 Mean change at week 16 Patient’s global assessment of disease activity (VAS)d Sample size, N 165 159 d 59 56 Baseline b –3 –10 Mean change at week 16 Physician’s global assessment of disease activityd Sample size, N 158 159 d 55 56 Baseline –8 –19 Mean change at week 16b HAQ-DI scoree Sample size, N 165 159 1.2 1.2 Baselinee b –0.09 –0.2 Mean change at week 16 f CRP Sample size, N 166 167 f 1.1 0.8 Baseline a 0.1 –0.1 Mean change at week 16 Scale, 0-78. Mean changes from baseline are least square means from analyses of covariance. c Scale, 0-76. d 0 = best; 100 = worst. e 0 = best; 3 = worst; the HAQ-DI measures the subject’s ability to perform daily activities, including dressing, eating, walking, griping, maintaining hygiene. f Reference range, 0-0.5 mg/dL. ACR indicates American College of Rheumatology; CRP, C-reactive protein; HAQ-DI, health assessment questionnaire disability index; PsA, psoriatic arthritis; VAS, visual analog scale. Source: Otezla (apremilast) tablets prescribing information; March 2014. a

RHEUMATology Practice Management

I August 2014

renal impairment; a reduction in dose to 30 mg once daily is recommended.9

Conclusion The FDA approval of apremilast marks the availability of the first oral treatment option for patients with active psoriatic arthritis. Having an oral option can be important for patients who are unable or unwilling to use other therapeutic options. The safety and efficacy of apremilast, a novel PDE-4 inhibitor, were demonstrated in 3 randomized, double-blind, placebo-controlled trials that involved 1493 patients. In all 3 studies, a statistically significant proportion of patients receiving apremilast achieved an ACR20 response at week 16 compared with placebo. Treatment with apremilast 30 mg twice daily also resulted in improvement for each ACR component, including tender joints, swollen joints, and physical function. l References

1. Cleveland Clinic Foundation. Psoriatic arthritis. http://my.clevelandclinic.org/orthopaedics-rheu matology/diseases-conditions/hic-psoriatic-arthritis. aspx. Accessed May 1, 2014. 2. National Institutes of Health. Psoriasis. Fact sheet. Updated October 2010. http://report.nih.gov/ NIHfactsheets/Pdfs/Psoriasis%28NIAMS%29.pdf. Accessed April 28, 2014. 3. Emery P, Ash Z. American College of Rheumatology. Psoriatic arthritis. Updated September 2012. www.rheumatology.org/Practice/Clinical/ Patients/Diseases_And_Conditions/Psoriatic_ Arthritis/. Accessed May 1, 2014. 4. Lee S, Mendelsohn A, Sarnes E. The burden of psoriatic arthritis: a literature review from a global health systems perspective. P T. 2010;35:680-689. 5. Gelfand JM, Gladman DD, Mease PJ, et al. Epidemiology of psoriatic arthritis in the population of the United States. J Am Acad Dermatol. 2005;53:573-577. 6. Armstrong AW, Schupp C, Wu J, Bebo B. Quality of life and work productivity impairment among psoriasis patients: findings from the National Psoriasis Foundation survey data 2003-2011. PLoS One. 2012; 7:e52935. 7. Mayo Clinic staff. Psoriatic arthritis: treatment and drugs. January 29, 2014. Accessed May 1, 2014. 8. US Food and Drug Administration. FDA approves Otezla to treat psoriatic arthritis. Press release. March 21, 2014. www.fda.gov/newsevents/newsroom/pressan nouncements/ucm390091.htm. Accessed April 23, 2014. 9. Otezla (apremilast) tablets [prescribing information]. Summit, NJ: Celgene Corporation; March 2014. 10. Felson DT, Anderson JJ, Boers M, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727-735.

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

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nter, Gre Partner, Ca enville, NC rolina ased on gro up prefere state laws, nce rheumatology s and patients hav cians may e phy sior control. Bec limited options for may not wri cotic prescri pain ause of this te narptions for pat cians in , the 3 phy chronic pain ien simanagemen ts as part of for pat our practice prescribe North Car ients who we t. In Eastern narcotics olina, prim arth ary ritis pain con feel need long-term seldom wri te such pre care providers col trol. We hav FOR OFFIC to outside of scri E ADMINIST pain manage ptions, and in commanage these prescriptioe a protoRATORS, ment clin RHEUMATO ics, Medicapliance with the North ns that is LOGISTS, Carolina l Board. PHYSICIAN ASSISTAN From the TS, AND NU Continued on Editor RSE PR page 8 ACTITION ERS

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ancy Ellis’ day starts morning wit walk around h a office the get a feel for to greet colleagues and The adminis pressing issues of the day. trator of a busy rheum ogy practic atole, Ms Ellis may of the 26 peo ple who wor run into any k at Piedm ont Cont inued on page

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By Iris W. Nic Managers hols, President, Na tional Org ; Editor-in-C anization hief, Rhe for Rheum umatolog atology y Practic e are all awa e Manag re of the man ement challen y

ges and opp ortuniti we practices. As face in rheumato es log articles, new we see from the countle y s ss ings, we all blurbs, and listserv enc oun ter similar postWe strive things. for quality (our physici ans are kno improvement wn to be lead in this area ), we have ers ongoing per for-

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