Rheumatology Practice Management

RHEUMATOLOGY PRACTICE

MANAGEMENT

™

FOR RHEUMATOLOGISTS, PRACTICE MANAGERS, FINANCIAL COUNSELORS, AND REIMBURSEMENT SPECIALISTS

www.RheumatologyPracticeManagement.com

Let Your Voice Be Heard: Medicare Part B

By Ethel Owen Editor-in-Chief, Rheumatology Practice Management President, National Organization of Rheumatology Managers

Implementing a Robust HIPAA Compliance Program in a Medical Practice

By Angela E. Simmons Consultant, Total Medical Compliance, Charlotte, NC

A

s we move into another year, it is important now more than ever for medical practices to ensure that they have a robust Health Insurance Portability and Accountability Act (HIPAA) compliance program in place. In 2009, the Office for Civil Rights (OCR) was appointed as the enforcement arm for Continued on page 11

CONFERENCE NEWS

Andrea Zlatkus and Ethel Owen

Smoking and Obesity Blunt Treatment Response in Patients with RA

By Alice Goodman

I

n our last issue, we discussed ways for rheumatology practice managers, physicians, healthcare professionals, and patients to get involved and raise awareness about concerns surrounding the Medicare Part B Drug Payment Model Proposed Rule by the Centers for Medi-

London, United Kingdom—Smoking and obesity reduce the likelihood of treatment success in patients with early rheumatoid arthritis (RA).1 The negative effects of smoking and obesity are present in both sexes, but were more robust in women according to the results of a study presented at the 2016 European League Against Rheumatism

Continued on page 7

Continued on page 18

The official publication of

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

Copyright © 2016 Engage Healthcare Communications, LLC

EDITORIAL ADVISORY BOARD EDITOR-IN-CHIEF Ethel D. Owen President, NORM Practice Administrator Arthritis & Rheumatology Associates West Palm Beach, FL

Marjorie Collings Practice Administrator Premier HealthCare Associates, Inc Richmond, VA

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

Allyson D. Eakin, RN, OCN, CCM Clinical Research Coordinator Arthritis & Osteoporosis Consultants of the Carolinas Charlotte, NC

Ana Reyes-Cartagena Director of Clinical Practice Arthritis & Rheumatism Associates, P.C. Wheaton, MD

Nancy Ellis Practice Administrator Piedmont Arthritis Clinic Greenville, SC

Jay Salliotte Business Manager Advanced Rheumatology Lansing, MI

Kyle C. Harner, MD Carolina Arthritis Center Greenville, NC

FOUNDING EDITOR-IN-CHIEF Iris W. Nichols Practice Administrator Arthritis & Osteoporosis Consultants of the Carolinas Charlotte, NC

Helen Hinkle Office Administrator Rheumatology Associates of South Texas San Antonio, TX

ENGAGE

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HEALTHCARE COMMUNICATIONS, LLC

Senior Vice President/Group Publisher

Nicholas Englezos nenglezos@the-lynx-group.com

Senior Vice President/Group Publisher

John W. Hennessy jhennessy2@the-lynx-group.com

RHEUMATOLOGY PRACTICE

MANAGEMENT

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FOR RHEUMATOLOGISTS, PRACTICE MANAGERS, FINANCIAL COUNSELORS, AND REIMBURSEMENT SPECIALISTS

Publisher

Joe Beck jbeck@the-lynx-group.com Editorial Director

Frederique H. Evans fevans@the-lynx-group.com Copyeditor

Hina Khaliq Editorial Assistant

Katharine Brzozowski Senior Production Manager

Melissa Lawlor

TABLE OF CONTENTS FEATURES From the Editor

Let Your Voice Be Heard: Medicare Part B......................................................1 President/CEO

By Ethel Owen

Brian Tyburski Senior Vice President/Group Publisher

Russell Hennessy rhennessy@the-lynx-group.com

Senior Vice President, Sales & Marketing

Philip Pawelko ppawelko@the-lynx-group.com Vice President, Finance

HIPAA Compliance

Implementing a Robust HIPAA Compliance Program in a Medical Practice..................................................................................................................1

By Angela E. Simmons

Andrea Kelly

Senior Financial Assistant

Audrey LaBolle

Director, Human Resources

Jennine Leale

Medical Director

Julie Strain

Director, Strategy & Program Development

Conference News

Smoking and Obesity Blunt Treatment Response in Patients with RA................................................................................................1

By Alice Goodman

John Welz

Editorial Director

Susan Berry

Director, Quality Control

Barbara Marino

Quality Control Assistant

Theresa Salerno

Director, Production & Manufacturing

Alaina Pede

Director, Creative & Design

Robyn Jacobs

DEPARTMENTS CMS News

Medicare Health, Drug Program Payment and Policy Updates for 2017 Finalized..................................................................................................9

Design Managers

Chris Alpino

Lora LaRocca

Director, Digital Marketing

Samantha Weissman

Digital Content Manager

Anthony Trevean

Continued on page 6

Digital Editor

John Parkinson Digital Media Specialist

Charles Easton IV

ASSOCIATION & CONGRESS DIVISION

Jr Digital Content Manager

Walford Guillaume

Junior Digital Developer

Christina Bethencourt

Sales Operations Manager

Margaret Hoffmann

Executive Administrative Assistant/Office Manager

Dana Rivera

Association Director

President

Abigail Adair Account Group Supervisor

Karie Gubbins

Account Supervisors

Patrice Melluso

Meeting & Event Planner

Linda Mezzacappa

Senior Account Executives

George Fuller

Administrative Assistant

Alex Charles Deanna Martinez

IT Manager

Senior Account Executives

Senior Project Coordinator

Business Development Advisor

Project Administrator

Colette Puhalski Kashif Javaid

Office Coordinator

Robert Sorensen

Jeremy Shannon

Meg Spencer

Saher Almaita

Project Manager

Rachael Baranoski Gretchen Dann Sara Mohamed

EHC1062-3

RHEUMATOLOGY PRACTICE

MANAGEMENT

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FOR RHEUMATOLOGISTS, PRACTICE MANAGERS, FINANCIAL COUNSELORS, AND REIMBURSEMENT SPECIALISTS

TABLE OF CONTENTS (Continued) DEPARTMENTS Wealth Management

Choosing a Business Entity for Your Rheumatology Practice......................13

By Gary S. Sastow and Lawrence B. Keller

NORM News

Y'all Ready for Mobile, AL?...............................................................................17

By Ginny Inman

Clinical Trials Tracker

Select Ongoing Clinical Trials Currently Enrolling Patients with Gout..............................................................................................20

Rheumatology Practice Management™, ISSN 2164-4403 (print); is published 6 times a year

by Engage Healthcare Communications, LLC, 1249 South River Rd, Suite 202A, Cranbury, NJ 08512. Copyright © 2016 by Engage Healthcare Communications, LLC. All rights reserved. Rheumatology Practice Management™ is a trademark of Engage Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including 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.

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MISSION STATEMENT

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

FROM THE EDITOR

Let Your Voice Be Heard… Continued from the cover care & Medicaid Services (CMS).

The National Organization of Rheumatology Managers (NORM) relies on each and every one of you to spread the word and take a role in advocating this important issue.

In line with our mission to promote and support education, expertise, and advocacy for patient access to care in rheumatology practices, we have been actively advocating for CMS to withdraw their proposal and work with physicians and other healthcare professionals to develop an alternative to effectively address the high costs of Part B medications.

The Coalition of State Rheumatology Organizations invited Andrea Zlatkus and me to attend meetings with CMS, CMMI, as well as House and Senate representatives in Washington, DC, with Vice President, Madelaine A. Feldman, MD, and Past President, Michael C. Schweitz, MD, to discuss our concerns with the Part B Demonstration Program. We shared our concerns about the cost of Part B drugs, and the size and scope of the demonstration as well as concerns regarding the ability of small practices to purchase medications at or below ASP. We also voiced our concerns about the aggressive timetables for implementing these changes.

Andrea and I wanted to share our Washington, DC, experience and encourage our membership to continue to oppose the Part B Drug Demonstration Project. We have held our first Town Hall meeting presented by Andrea and I, and moderated by Iris Nichols, Immediate Past President of NORM and founding Editor-in-Chief of Rheumatology Practice Management, to discuss the CMS Part B Demonstration Project, educate our members, and share what we, as an organization, have been doing.

Andrea Zlatkus, Madelaine A. Feldman, MD, Ethel Owen, and Michael C. Schweitz, MD

The Town Hall focused on the Part B Demonstration Project, explained how the program is part of CMS’ recent proposal to test new Medicare Part B prescription drug models. It is a 5-year plan with the goal to drive prescribing use of the most effective drugs, and test new payment approaches to reward positive patient outcomes.

The premise of this demonstration project is based on concerns that average sales prices (ASPs) +6% incentivize physicians to prescribe higher-cost drugs. The project comprises 2 phases; phase 1 includes the following groups: (1) ASP +6% control, and (2) ASP +2.5% plus a flat fee of $16.80 per drug daily. Phase 2 further subdivides these groups, adding value-based purchasing tools: • Group 1 o ASP +6% (control) o ASP +6% with value-based purchasing tools • Group 2 o ASP +2.5% and a flat-fee drug payment o ASP +2.5% and a flat-fee drug payment model with valuebased purchasing tools.

It is important to note that the value-based tools have not been clearly defined or developed. CMS is looking

at a variety of tools, such as reference pricing, discounting or eliminating patient cost-sharing, indication-based pricing, evidence-based clinical decision support tools, and risk-sharing agreements based on outcomes.

The comment period was closed May 9, and CMS is currently reviewing the comments they received. According to the best estimates, phase 1 of the project may be implemented by October 1, 2016, and phase 2, no earlier than January 1, 2017. Part B demonstration is also subject to sequestration, but what does this mean for drug reimbursement? Under the model of ASP +2.5% plus the $16.80 flat fee, we will be reimbursed approximately ASP +0.86% plus $16.46 per J code daily.

We look forward to our next town hall meeting in July (date to be determined) and hope you will be able to join us in this conversation. For more information, please visit the NORM website. The new Part B tab in the member’s-only page includes recorded webinars, as well as FAQs; notes from our trip to the Hill; and PowerPoint presentations from the webinar are also available. We must continue calling our representatives and thank them for their support. n

CMS NEWS

Medicare Health, Drug Program Payment and Policy Updates for 2017 Finalized And other Centers for Medicare & Medicaid Services news

T

he final Medicare Advantage and Part D Prescription Drug Program changes for 2017 have been released by the Centers for Medicare & Medicaid Services (CMS). These changes strive to provide plans with stable payments, and improve the program for plans that provide high-quality care to enrollees who are most vulnerable. In addition, CMS is confirming its policies to further combat opioid overuse, by encouraging the use of safeguards prior to dispensing an opioid prescription at a pharmacy, and retaining access to necessary medications.

Although these final policies bear semblance to those that were proposed in February, they include several changes that address feedback received during the public comment period. Without accounting for expected growth in coding acuity— which has typically added 2.2%— the expected revenue change, on average, is 0.85%. CMS notes that, largely because of technical updates in the risk adjustment normalization factor, the final revenue growth is a bit smaller than what was estimated in the February Advance Notice; however, the revenue increase is consistent with last year’s update, and mirrors a similar pattern in Medicare fee-for-service. Plans that improve the quality of care they provide to beneficiaries can get higher updates that, in turn, enrich the benefits they offer to enrollees.

“We continue to strengthen Medicare Advantage and Medicare Part D, in particular for enrollees who need additional investments in their health, such as dually Medicare-Medicaid eligible individuals and those with complex socioeconomic needs,” according to Andy Slavitt, Acting

Administrator, CMS, Baltimore, MD. “With these policies, we will continue to see improvements in growth, affordability, benefits, and quality for millions of seniors and people living with disabilities.”

New policies will advance the accuracy of payments to Medicare Advantage plans that serve vulnerable populations (eg, dually eligible or low-income beneficiaries); risk-adjusting payments to plans using a revised methodology will more precisely reflect the cost of care for dually eligible beneficiaries.

“We continue to strengthen Medicare Advantage and Medicare Part D, in particular for enrollees who need additional investments in their health.”

–—Andy Slavitt

The organization will also be implementing a temporary adjustment to the Star Ratings policy that reflects the socioeconomic and disability status of a plan’s enrollees. In addition, the finalized policies from CMS will provide the Medicare Advantage program in Puerto Rico with much needed stability. CMS asserts that this announcement regarding finalization of Medicare Health and Drug Program payment and policy updates drives payment improvements for Medicare Advantage plans, and continues promoting improvements to

quality of care for beneficiaries.

“Together, these changes will ensure the Medicare program remains strong and stable for current and future enrollees,” the CMS press release concludes.

Centers for Medicare & Medicaid Services. CMS finalizes 2017 payment and policy updates for Medicare health and drug plans. www.cms.gov/News room/ MediaReleaseDatabase/Press-releases/2016-Pressreleases-items/2016-04-04.html. Published April 4, 2016. Accessed May 31, 2016.

CMS INCREASES TRANSPARENCY OF MEDICARE PART B PROGRAM The third annual Physician and Other Supplier Utilization and Payment Public Use data released by CMS, which includes summarized information regarding Part B services that physicians and other healthcare professionals provide to beneficiaries of Medicare, increases the transparency of the Part B program, according to a recent announcement by CMS. The organization has also announced the accessibility of more timely data for researchers.

These updated 2014 data have been released in tandem with the conduction of the 7th annual Health Datapalooza conference in Washington, DC, and includes information for >986,000 different healthcare providers—compared with the 950,000 covered in 2013—who collectively received $91 billion in Medicare payments (vs $90 billion in 2013).

Information about payment, submitted charges, and bills for services and procedures provided by each physician or supplier is relayed in the Physician and Other Supplier Utilization and Payment Public Use data update, and can be compared by physician, specialty, location, types of medical services and procedures Continued on page 10

CMS NEWS

Medicare Health, Drug Program... delivered, Medicare payment, and submitted charges.

There is also new information about the Medicare standardized payment amount, which eliminates discrepancies in payment rates for individual services based on geographic variances (eg, those that account for local wages or input prices), and makes them comparable. Of note, beneficiaries’ personal information is protected in all of CMS’ data releases.

“This week’s announcements underscore CMS’ ongoing commitment to releasing data and information to promote a vibrant health information economy,” stated Niall Brennan, Chief Data Officer, CMS, Baltimore, MD. For researchers accessing Medicare claims data via Limited Data Sets (LDS), CMS is making the information timelier. In the past, researchers could only use the LDS request process for annual extracts of Medicare data, but with the new changes CMS has announced, updates to LDS claim files can be requested by researchers as frequently as every quarter. This will make it easier for important research to be carried out, which will, in turn, result in better quality and lower costs in the healthcare system.

CMS has stressed that, as Medicare gradually pays healthcare providers based on the quality—versus quantity—of care they provide to patients, the release of timely, privacy-protected data is particularly vital.

Centers for Medicare & Medicare Services: Updates to data initiatives increase transparency of the Medicare Program. www.cms.gov/Newsroom/MediaReleaseData base/Press-releases/2016-Press-releases-items/2016-0505.html. Published May 5, 2016. Accessed May 26, 2016.

PART B FACES BACKLASH FROM THE RHEUMATOLOGY COMMUNITY In a recent comment letter sub-

“The proposed new methodology does not adequately consider the higher average costs many of our physicians have acquiring, handling, administering, and billing for drugs and biologics.”

–—American College of Rheumatology

mitted to the CMS, the American College of Rheumatology (ACR) urged CMS to remove or significantly edit their controversial Part B payment proposal. The ACR purports that the CMS proposal will have a distressing impact on rheumatology patients who rely on Medicare Part B for gaining access to the biologic therapies they need.

Citing that the CMS neglected to involve the physician community when deciding the best ways to address the complex policy issues surrounding the effective treatment of patients with different needs, the ACR stressed that a “one-size-fitsall” solution is not appropriate for the complexity of this issue.

The letter also elaborates on the negative impact the Part B payment proposal would have on patients with regard to more expensive copays and fees, travel times, and administration of therapies without the supervision of their rheumatologist, as well as on practices and physicians.

“Although we certainly seek to control costs for patients and Medicare wherever possible, the proposed

Continued from page 9

new methodology does not adequately consider the higher average costs many of our physicians have acquiring, handling, administering, and billing for drugs and biologics,” the letter stated. “We are deeply concerned that because the new methodology will frequently not properly cover the costs of physician administration of infused drugs, they will be forced to stop offering patients the ability to receive infusion treatments.”

The ACR asserts that, because of the new proposal, patients—some of whom already travel lengthy distances to access vital services—will have no choice but to seek more costly or less safe alternatives at outpatient services and freestanding infusion treatment centers that do not have onsite physician supervision, or skip treatment altogether.

Furthermore, concerns are expressed about reimbursements accurately reflecting physicians’ acquisition and administration costs. “We encourage CMS to re-evaluate the fixed fee and align such an add-on payment to reflect costs of administering the infusion,” the letter adds. “In addition, we believe that CMS should evaluate undertaking a demonstration proposal to permit physicians to pool together in order to purchase drugs from manufacturers.”

Notably, the ACR stresses that, if CMS implements the proposed new methodology, it should be done in a limited geographic area to evaluate and identify weaknesses of the policy (eg, beneficiary access issues) before being established on a national level. n American College of Rheumatology. Rheumatology community urges CMS to withdraw or significantly modify Part B payment demo, citing devastating impact to rheumatology patients and providers. www.rheuma tology.org/About-Us/Newsroom/Press-Releases/ID/ 744/Rheumatology-Community-Urges-CMS-toWithdraw-or-Significantly-Modify-Part-B-PaymentDemo-Citing-Devastating-Impact-to-Rheuma­tologyPatients-and-Providers. Published May 5, 2016. Accessed May 26, 2016.

HIPAA COMPLIANCE

Implementing a Robust HIPAA...

HIPAA, and with that appointment came a mandate by Congress to begin auditing entities that fall under the HIPAA rules.

In 2012, the OCR implemented its pilot audit program. During the pilot audit phase, 115 covered entities were audited for compliance with various provisions of the Privacy, Security, and Breach Notification Rules. Since then, the OCR has developed its full audit program, and in September 2015, Jocelyn Samuels, Director of the OCR, announced that she fully expected the OCR’s audit program to kick off sometime by the first quarter of 2016. This article finds us firmly within that time frame.

WHAT MAKES A GOOD HIPAA COMPLIANCE PROGRAM? The question now becomes, what should every medical office be doing to ensure that it can demonstrate compliance with the HIPAA rules?

The cornerstone of any HIPAA compliance program is its policies and procedures. Ensuring that every employee understands the HIPAA policies and procedures is a huge part of your HIPAA compliance program, but there is more to a compliance program than only a manual.

So, what constitutes a good HIPAA compliance program?

A well put together HIPAA compliance program has the following components: 1. A privacy and security official (which may be the same person) 2. Professional information technology (IT) support 3. Documented, communicated, and enforceable policies and procedures 4. Documentation of compliance with the HIPAA rules (forms and contracts) 5. Training 6. Sanctions 7. Safeguards.

Continued from the cover

devices, and, most important, its patients’ information. Without professional IT support, there is no way for any organization to truly know if there have been any malicious attempts to gain access to the network or to patients’ information. At the very least, all practices should have IT-managed antivirus programs and firewalls in place for protection.

The cornerstone of any HIPAA compliance program is its policies and procedures.

Privacy and Security Official Each organization is required by HIPAA to appoint someone as its privacy officer. This person is responsible for ensuring that HIPAArelated policies and procedures are in place, are updated appropriately, are communicated, and are enforced when needed. This person is also responsible for investigating, documenting, and reporting HIPAA security breaches to the US Department of Health & Human Services and to the patient when required by law. The privacy officer’s name and contact information are made available on the organization’s Notice of Privacy Practices, which should be posted in the waiting area and on the organization’s website (if one exists).

Professional IT Support In today’s very connected world, it is of utmost importance that every medical practice work with a professional IT group to ensure the security of its network, computers, tablets,

Documented, Communicated, and Enforceable Policies and Procedures There are no policies unless they are documented, communicated to the employees, and enforceable by rule. Working with a third party to develop sound policies is a very good idea when it comes to HIPAA compliance. Any policy manual must encompass the HIPAA rules and the culture of the organization.

It is important to remember that what the policy indicates an organization does by rule is what the US Department of Health & Human Services and the OCR (which enforces the rules) will expect an organization to demonstrate. How does your office demonstrate that there are policies and procedures in place, that they are communicated to employees, and that they are enforceable? In addition, medical practices should be able to demonstrate that they update their policies and procedures at least on an annual basis.

Documenting Compliance with HIPAA Rules Every practice must have certain forms and contracts in place to demonstrate compliance with HIPAA rules, including: 1. Notice of privacy practices 2. Acknowledgment of receipt of the privacy practices 3. Authorization (HIPAA-compliant) Continued on page 12

HIPAA COMPLIANCE

Implementing a Robust HIPAA...

4. Business associate agreements or contracts 5. Risk analysis 6. Taking inventory of the location of the electronic protected health information 7. Contingency planning 8. Corrective actions plans as needed.

Again, it is a very good idea to work with a third party in the development of these forms to ensure their adherence and compliance with HIPAA rules.

Training Under the Privacy Rule, all members of the workforce must be educated on the HIPAA rules, including administrative staff and doctors or other providers within the organization. Training should occur when an entity first adopts HIPAA policies, for any new employees, for existing employees on an annual basis, and as required for certain roles that may necessitate more in-depth knowledge of the policies.

In addition, training should occur after any incident involving a violation of HIPAA rules. It is important for medical practices to ensure that they can demonstrate a teachable moment when things go wrong, as they sometimes will. Training should always include information on HIPAA rules, the policies and procedures for the practice, and the sanctions for nonadherence to the rules. Medical practices should also release periodic reminders on topics such as e-mail safety and policy, computer use policies, and other security issues as they arise throughout the year. Remember that every aspect of HIPAA compliance must be documented, including training.

Sanctions Without a doubt, the least appealing aspect of any rule is enforcement;

however, it goes without saying that you truly do not have rules if they are not enforceable. Moreover, the HIPAA rules require medical entities to have sanctions policies that they can demonstrate are enforceable.

Sanctions must apply equally to all members of the workforce. A good sanctions policy will include levels of sanctions as they relate to specific actions. Organizations may elect to start with verbal warnings and then move to more rigid penalties for violations of HIPAA rules. The sanctions must reflect the organization’s philosophy, and they must be written so that they can be enforced without hesitation. Do not write a rule that you are not willing to enforce.

Safeguards Every organization that falls under HIPAA rules is required to put appropriate safeguards in place that must be designed to protect the confidentiality, integrity, and availability of patient information. In other words, information that must be kept confidential is not viewed or used by any person who is not authorized to have such access.

Next, the integrity of information ensures that the data are not changed by any person who does not have the authorization to do so. This includes members of the organization who are not authorized to access certain records or other protected health information.

Finally, the information we create, maintain, and store regarding our patients must be available when needed. We must have an up-to-date contingency plan in place, and we have to work with a reputable and professional IT group that can monitor and ensure that the confidentiality, integrity, and availability of patient information are maintained.

The HIPAA rules specifically address the need for administrative,

Continued from page 11

technical, and physical safeguards to be put in place, such as: • Administrative: policies and procedures, risk analysis, and awareness and training programs • Technical: identity and access management, auditing, and network infrastructure safeguards • Physical: facility access management, maintenance record keeping, and workstation security.

A good HIPAA compliance program is more than just a manual or policies and procedures. It is also your documentation and training, as well as your sanctions and safeguards.

Your compliance program must be documented, communicated, and enforceable. It is not a program that can be put in place overnight or reviewed one time and then forgotten.

HIPAA compliance must become an integral part of the culture of every medical practice, beginning with the administrative or management staff, and then must permeate throughout the entire practice. n About the Author Angela Simmons is a Consultant for Total Medical Compliance (TMC).

TMC is a private consulting company providing programs and seminars for healthcare providers to achieve and maintain compliance with government safety and privacy regulations such as HIPAA, OSHA, and Infection Control. A TMC consultant works in partnership with the safety and privacy officers at your location to ensure all aspects of the regulations are addressed.

TMC provides on-site employee training, customized compliance manuals, office inspections, and ongoing support with newsletters and customer service.

For information on seminar schedules and products, visit www.TotalMedical Compliance.com. For more information, call 888-862-6742 or e-mail Angela@totalmedicalcompliance.com.

WEALTH MANAGEMENT

Choosing a Business Entity for Your Rheumatology Practice

By Gary S. Sastow, Esq, and Lawrence B. Keller, CFP, CLU, ChFC, RHU, LUTCF

H

ealthcare providers in private practice often ask whether they should form a legal entity. You need to decide if you want to “incorporate,” and to determine which business entity is best for you based on your individual needs and goals. This article will highlight why you should consider forming a legal entity, as well as review some important aspects associated with the most common legal business entities available.

WHY CONSIDER FORMING A LEGAL ENTITY? Because physicians are personally responsible for their own professional negligence or malpractice, regardless of whether they practice with or without a legal entity, what is the benefit of having one? Although a legal entity does not provide any liability protection from professional negligence or malpractice, it does shield you from liabilities that result from the actions of others.

One example may be a patient who slips and falls in your office and subsequently sues for the injuries sustained.

Rather than being sued personally, the legal entity is sued, and your personal assets are not at risk. Although commercial liability insurance would likely cover such an occurrence, having a legal entity further insulates your personal assets. Other examples may include landlord and tenant disputes, disputes with vendors, and the liability associated with an employee of your practice or another physician or owner of the practice.

CHOOSING AN ENTITY FOR YOUR RHEUMATOLOGY PRACTICE The type of business entity under

Gary S. Sastow

Lawrence B. Keller

which you can choose to practice normally includes partnerships, corporations, and limited liability companies (LLC). Each category has its own advantages and disadvantages in terms of personal liability protection, tax treatment, flexibility, and administration. For this reason, it is important to review all the details with your attorney and your accountant before making a final decision.

ible by a corporation may not be deductible by a sole proprietorship.

Sole Proprietorship A sole proprietorship is the easiest way to structure your medical practice, because no separate legal entity is actually formed. A sole proprietor’s business is simply an extension of the sole proprietor. Sole proprietors are liable for all business debts and other obligations the business may incur.

This means that your personal assets can be subject to the claims of your business’s creditors.

For federal income tax purposes, all business income, gains, deductions, or losses are reported on Schedule C of your Form 1040. Although a sole proprietorship is not subject to corporate income tax, some expenses that may be deduct-

Partnership In a partnership, 2 or more people form a business for mutual profit.

Therefore, if you are going to own a medical practice with at least 1 other physician, then a partnership is a viable option to consider. However, in a general partnership, all partners have the capacity to act on behalf of one another and with full authority on behalf of the practice. This also means that each partner is personally liable for any acts of the others, and all partners are personally responsible for the debts and liabilities of the practice.

It is not necessary that each partner contributes equally to the practice or that all partners share equally in the profits, which will be reflected in the partnership agreement. In fact, in most businesses it is not uncommon for one partner to contribute a majority of the capital while another contributes the business acumen or contacts, and for the 2 partners to share the profits equally.

Although a partnership is a recogContinued on page 14

WEALTH MANAGEMENT

Choosing a Business Entity… nized legal business entity in the sense that the entity can obtain credit, file for bankruptcy, and transfer property, among other things, a partnership is not itself a taxpaying entity and, generally, only files an information income tax return (Form 1065). Each partner receives a Schedule K-1 from that return (the income, gains, deductions, and losses of the partnership), and then reports the information from the Schedule K-1 on Schedule E of Form 1040.

S Corporation An S corporation is formed by filing Articles of Incorporation with the state. The election of S corporation status is made by filing with the Internal Revenue Service (IRS; Form 2553), making a state-level S corporation election after incorporating your business, and the decision must be unanimous among shareholders. An S corporation is a corporation that has made an election to have its income, deductions, capital gains and losses, charitable contributions, and credits passed through to its shareholders.

To a great extent, an S corporation is treated for tax purposes like a partnership. However, the S corporation retains some features of the corporation, such as limited liability of shareholders. S corporations also require some operational formalities, including regular meetings of shareholders and a board of directors, written minutes of those meetings, and corporate resolutions authorizing certain actions.

Generally, an S corporation only files an information income tax return (Form 1120S); each shareholder receives a Schedule K-1 from that return (for the income, gains, deductions, and losses of the S corporation) and reports the information from the Schedule K-1 on

Continued from page 13

Schedule E of Form 1040. Without an S corporation election, the business will be taxed as a C corporation. Although the business may consist of many owners, it is considered a single entity that is separate from the owners.

An S corporation must be a domestic corporation and must not have more than 10 shareholders.

Although an S corporation may have only 1 class of common stock, IRS regulations have permitted S corporations to issue voting stock

Although a legal entity does not provide any liability protection from professional negligence or malpractice, it does shield you from liabilities that result from the actions of others.

portion of the Federal Insurance Contributions Act phases out after you reach an income of $118,500 (for 2016), the 2.9% Medicare tax has no phase-out. Wages of more than $200,000 that are earned in 2016 will face an extra 0.9% Medicare tax, which will be withheld from employees’ wages (employers are not responsible for this additional tax). In addition, qualified retirement plan contributions are limited by the W-2 income for the S corporation owner.

The consensus among experienced certified public accountants is that the W-2 “salary” must be reasonable. This is the amount that you could earn if you worked somewhere else in a similar capacity. The remaining amount would then be paid as a distribution to avoid paying Social Security and Medicare taxes on that income.

Generally, S corporations are also audited less frequently than sole proprietorships.

and nonvoting stock. Both kinds of stock, however, must have the same rights with regard to allocation and distribution of earnings. The S corporation is also attractive because income is only taxed once, not twice, as is the case with a C corporation. The corporate alternative minimum tax and the tax on unreasonable accumulations of income also do not apply.

Generally, if you are a shareholder physician, you are paid as an employee of the practice with a W-2 form, and as an owner of the practice via a K-1 distribution. The main difference is that you pay Medicare and Social Security tax on W-2 income but not on K-1 distributions.

Although the large Social Security

C Corporation A C corporation is formed by filing Articles of Incorporation with the state. C corporations require a great number of operational formalities, including bylaws, regular meetings of shareholders and a board of directors, written minutes of those meetings, and corporate resolutions authorizing certain actions.

A C corporation is owned by its shareholders, who elect a board of directors, which is responsible for managing the business. The board, thus, elects officers to run the company. The shareholders are investors who contribute cash, property, or services for their stock, and their liability for the corporation’s debts and obligations is limited to the amount of their investments. C corporations can also have several classes of stock

WEALTH MANAGEMENT

(common stock and preferred stock are good examples).

C corporations pay taxes at the entity level. They file a corporate tax return (Form 1120) and pay taxes at the corporate level, and then may distribute the remaining earnings as dividends to the owners.

The dividends are not deductible to the corporation, and are income for the owners of the corporation.

Therefore, a C corporation is subject to double taxation on earnings.

The double taxation of corporate earnings was reduced by the Jobs and Growth Tax Relief Reconciliation Act of 2003, which made dividends taxable at the same rate as capital gains.

nership (LLP) is a general partnership that is managed by its partners and is taxed like a partnership, but the partners’ liability for any professional malpractice of other partners is limited to partnership assets.

The partners of an LLP have more liability protection than partners of a general partnership, but they still have unlimited personal liability for obligations of the practice.

To form an LLP, the partners must file a form with the secretary of state, and annual renewal of registration is required to maintain the protection from liability. The name of the business entity must include a designation that it is an LLP (ie, LLP or LP must appear in the name).

Limited Liability Partnership Most states allow professionals, such as physicians, lawyers, and accountants, to form an entity similar to the LLC. A limited liability part-

Limited Liability Company An LLC is formed by filing Articles of Organization with the state, and all members must sign an operating agreement. The members con-

tribute cash, property, or services, and income is apportioned according to the contributions of the members. The name of the business entity must include a designation that it is an LLC (ie, LLC or LC must appear in the name). As a default, the LLC is taxed as a partnership or sole proprietor.

The LLC must elect to be treated as a corporation. Unlike an S corporation, an LLC permits unequal allocation of profit and loss, while affording the same limited liability that the equity owners receive when organized as a corporation. Unlike partners in a limited partnership, all LLC members can take an active role in the operation of the business without exposing themselves to personal liability. In California, professionals are not allowed to form an LLC or a professional LLC, and instead must form a professional corporation or a registered LLP. Continued on page 16

WEALTH MANAGEMENT

Choosing a Business Entity…

Professional Corporation A professional corporation, sometimes known as a qualified personal service corporation, is a special type of corporation composed of professionals who require a license to practice. Under the tax code, a qualified personal service corporation is defined as a corporation formed under state law in which substantially all of the activities involve services in the fields of health, law, engineering, accounting, actuarial science, performing arts, or consulting.

To form a professional corporation, you must file Articles of Incorporation with the secretary of state and pay a filing fee. Compared with an ordinary corporation, which may be formed for any lawful purpose, a professional corporation’s articles must limit its corporate purpose to the practice of the profession that its shareholders are licensed to perform.

Unlike ordinary corporations, professional corporations must usually also obtain approval from the state professional licensing board that regulates the profession. The state licensing board will ensure that all shareholders are licensed professionals in good standing. Such corporations must also identify themselves as professional corporations (by including PC or P.C. after the firm’s name).

Although most state laws forbid professionals from forming regular corporations, the urge to incorporate reflects a desire to take advantage of Internal Revenue Code provisions that grant more generous deductions or other tax benefits to corporate employee benefit plans than to similar plans created by self-employed individuals. The owners of a professional corporation are its shareholders, who perform services for the corporation as employees.

Continued from page 15

The IRS imposes 2 tests to ensure that a corporation under state law qualifies as a personal service corporation. These tests focus on what the corporation does (the “function test”) and how it is owned (the “ownership test”). If a professional corporation does not qualify as a personal service corporation, then it is generally treated under the tax code as a C corporation. Keep in mind, however, that a professional corporation can elect to be treated for tax purposes as an S corporation.

A qualified personal service corporation is defined as a corporation formed under state law in which substantially all of the activities involve services in the fields of health, law, engineering, accounting, actuarial science, performing arts, or consulting.

The tax treatment will largely depend on how much of the outstanding stock is owned by employee shareholders. In general, however, a professional corporation is a separate entity from its owners, similar to a C corporation. Therefore, it must file its own corporate tax return annually, and it may offer many of the fringe benefits available to C corporations. As noted, however, a professional corporation can elect to be treated as an S corporation.

Qualified personal service corporations must use a calendar tax year, unless a business purpose for a fiscal year is established and they are not taxed at the same graduated rates that apply to C corporations. Rather, professional corporations are taxed at a flat 35% rate on their taxable incomes. Professional corporations are subject to the passive activity loss rules and the at-risk rules. For more information regarding these rules, be sure to speak with your accountant and attorney, because it is beyond the scope of this article.

CONCLUSION There is no single best form of ownership for a business. This article provides a brief overview of the most common legal entities available and highlights some important aspects associated with each. You should consult with your attorney and accountant to weigh the pros and cons of each type of legal business to determine which best meets your individual needs and goals. After you have chosen your entity, be prepared to reassess your situation as your practice evolves and your personal circumstances change. n

Gary S. Sastow, Esq, is a partner in Brown, Gruttadaro, Gaujean & Prato, PLLC, a New York–based law firm providing legal services to healthcare professionals and other business owners.

He can be reached at 914-949-5300 or by e-mail at gsastow@bggplaw.com with comments or questions.

Lawrence B. Keller, CFP, CLU, ChFC, RHU, LUTCF, is the founder of Physician Financial Services, a New York–based firm specializing in income protection and wealth accumulation strategies for physicians. He can be reached at 516-677-6211 or by e-mail at Lkeller@physicianfinancialservices. com with comments or questions.

NORM NEWS

Y’all Ready for Mobile, AL?

By Ginny Inman

W

ith the 2016 National Organization of Rheumatology Managers (NORM) Conference happening in Mobile, AL, on September 16 and 17, we wanted to learn more about our host town. We sat down with Stacy Hamilton, Vice President of Marketing and Communications for Visit Mobile, so she could give us the inside scoop on how to act like a local in the Azalea City.

Tell us a little about Mobile.

Stacy Hamilton [SH]: Founded in 1703, Mobile is one of the oldest cities on the Gulf Coast—really, one of the oldest in the South. It is a colorful, eclectic, and cultured town full of warm and friendly people. We love to celebrate anything—big or small—and welcome newcomers with a genuine, ‘we’re so happy you’re here’ attitude.

This will be a lot of people’s first time in Mobile Bay. Can you tell us about some of the great attractions nearby?

SH: I think our historic downtown and neighboring historic districts are

For more information about Mobile, AL, go to: • www.mobile.org/mobilecharm or www.mobile.org/thingstodo • https://blog.mobilebay.org • www.facebook/visitmobile so worth exploring first—you can do that by foot or car, or take a city tour on a van, trolley, or duck boat. Starting off your visit to Mobile with a tour gives you some idea of just how special, beautiful, and historic our city is.

In addition, signature attractions like the USS ALABAMA, the History Museum, The Carnival Museum, the Gulf Coast Exploreum and the new (and truly one of a kind) GulfQuest National Maritime Museum are all worth visiting.

We are hosting the 2016 NORM Conference at the Mobile Convention Center. Can you tell us about anything within walking distance people should check out?

SH: I would definitely recommend wandering up, down, and just off of Dauphin Street—our historic entertainment district—to find shops, new bars and restaurants, art galleries, an-

tique stores, and live music venues.

What is something unique that visitors can do in Mobile in an afternoon?

SH: Either the city tour, renting a kayak/canoe, riding an airboat, or chartering a sightseeing cruise to explore the nation’s second largest delta (ie, the Mobile-Tensaw River Delta), which is just minutes from downtown.

Is there anything else you would like to add?

SH: Don’t be afraid to say hi or ask questions; Mobilians are proud and happy to show off their beloved town, and want you to love it, too! n Reprint permission from the National Organization of Rheumatology Managers.

Y’all Ready for Mobile, AL? by Ginny Inman. Published June 1, 2016. www. normgroup.org/yall-ready-mobile-al.

CONFERENCE NEWS

Smoking and Obesity…

Annual Congress (EULAR 2016).

“We have great medications for the treatment of RA. Patients come in all the time asking what they can do,” explained Susan Bartlett, PhD, Associate Professor, Faculty of Medicine, Divisions of Clinical Epidemiology, Respiratory Epidemiology and Rheumatology, McGill University, Montreal, Canada, and lead author of the study. “This study adds to the evidence for the benefits of stopping smoking and losing weight and shows that it is particularly impor­ tant if you want the RA medications to work well. We should be telling this to patients at the first visit after diagnosis.” Although sustained remission is an important treatment goal in early RA, <50% of patients achieve this goal within the first 3 years of treatment, and will continue to deteriorate.

The study was based on a cohort of 1008 patients with early RA enrolled in the multicenter, prospective Canadian Early Arthritis Cohort (CATCH) study. Patients were followed prospectively from the time of diagnosis through their first 3 years of treatment to estimate the time to sustained remission, defined as remission (Disease Activity Score 28, <2.6) at ≥2 consecutive visits to the rheumatology clinic. At baseline, mean age of patients in the study was 53 years; 72% of the participants were women, and 81% were white. Overall, 30% of women and 47% of men were overweight, 33% of both sexes were obese, and 15% to 20% were smokers. At entry, approximately 75% of patients were treated with methotrexate alone or as part of a combination therapy, roughly 50% received steroids, and 3% were treated with a biologic. At 3 years, 38% of patients had achieved sustained remission, with a median

Continued from the cover

“Stopping smoking and losing weight...is particularly important if you want the RA medications to work well.”

—Susan Bartlett, PhD

time to remission of 11.3 months.

“When we looked more closely at who was and was not achieving remission, we found that people who smoked and those who were overweight or obese were much less likely than their non-smoking or normal-weight peers to be in sustained remission,” Dr Bartlett stated.

DIFFERENCES BETWEEN SEXES Overall—and even though more men were overweight—men did better than women, with the effects of weight and smoking appearing to be significantly more difficult among women (P = .02). Looking at weight separately, obese people were 50% less likely to achieve remission than their normal-weight counterparts.

Smoking also impacted treatment success. A significant 3-way interaction was observed for sex, weight, and smoking (P = .02).

A nonsmoking man with a healthy body mass index (BMI) would have a 41% probability of achieving sus-

tained remission within 3 years, whereas the probability drops to 15% for an obese man who is a smoker.

Among women, a nonsmoker with a healthy weight would have a 27% probability of achieving sustained remission within 3 years, compared with only 10% for a woman who smokes and is obese.

The mechanisms behind smoking cessation and weight loss are not well-established. There are data suggesting that adipose tissue activates inflammatory cytokines that can worsen RA. BMI, SMOKING, AND TREATMENT NONRESPONSE In support of the CATCH study, researchers behind a second abstract presented at EULAR 2016 found that BMI and smoking were significant predictors of nonresponse after 6 months of methotrexate treatment in 549 adult patients with RA.2 Odds ratios for nonresponse were as follows: BMI, 1.06 (P <.01); current smokers, 1.59 (P = .04).

“These factors that predict nonresponse are modifiable,” explained Suzanne Verstappen, MD, Arthritis Research UK Centre for Epidemiology, Centre for Musculoskeletal Research, Institute of Inflammation and Repair, The University of Manchester, United Kingdom, who coauthored the second study. n REFERENCES

1. Bartlett SJ, Schieir O, Schulman OE, et al. How much of a barrier is excess weight and smoking for achieving sustained remission in early RA? Results from the Canadian Early Arthritis Cohort. Presented at: 2016 European League Against Rheumatism Annual Congress; June 8-11, 2016; London, United Kingdom. https://b-com.mci-group.com/Abstract/Statistics/ AbstractStatisticsViewPage.aspx?AbstractID=304435.

Accessed June 10, 2016.

2. Sergeant JC, Hyrich KL, Anderson J, et al. Prediction of non-response to methotrexate therapy in the Rheumatoid Arthritis Medication Study (RAMS).

Presented at: 2016 European League Against Rheumatism Annual Congress; June 8-11, 2016; London, United Kingdom. https://b-com.mci-group.com/Ab stract/Statistics/AbstractStatisticsViewPage.aspx?Ab stractID=304312. Accessed June 10, 2016.

CLINICAL TRIALS TRACKER

Select Ongoing Clinical Trials Currently Enrolling Patients with Gout The following clinical trials represent a selection of key clinical trials that are currently recruiting patients with gout for inclusion in investigations of new therapies and regimens of available therapies for patients with gout. Each clinical trial description includes the NLM Identifier to be used as a reference for Clin icalTrials.gov. The information below can help rheumatology practice managers and providers direct their eligible patients to one of these clinical trials.

1

Identifying Genetic Variations in Patients Exposed to Allopurinol As part of this interventional, single-group, open-label trial, the investigators seek to evaluate genetic variations in patients with gout. In particular, they are looking at how the variations in the genetic transporters may influence the disposition of serum uric acid in response to allopurinol, as well as the nature of its active metabolite, oxipurinol. Men and women aged ≥18 years may be eligible for enrollment in the study if other criteria are met, including a selfreported history of gout, history of active use of xanthine oxidase inhibitors, or evident serum uric acid levels ≥6 mg/dL. Criteria for exclusion include pregnant women; estimated creatinine clearance <30mL/ min; elevated liver enzymes; contraindication to receiving allopurinol; and active participation in other clinical trial.

Patients participating in this trial will undergo uric acid measurement twice daily at baseline, and after 14 days. Primary outcomes of interest

are percent change from baseline in serum uric acid level, and steadystate oxipurinol area under the serum concentration-time curve at 14 days. Secondary outcomes of interest are percent change from baseline in uric acid fractional excretion and renal clearance, during the same time frame.

Approximately 100 patients will be enrolled in this trial at the University of Minnesota, Minneapolis.

For more information, contact Robert J. Straka, PharmD, at 612-6245663 or strak001@umn.edu. The NLM Identifier is NCT02371421.

The purpose of this study is to determine the relationship between purine metabolism enzyme single-nucleotide polymorphisms and uric acid production.

2

The Link Between Purine Metabolism and Uric Acid Production The purpose of this study is to determine the relationship between purine metabolism enzyme single-nucleotide polymorphisms and uric acid production. Response to xanthine oxidase inhibitors will also be evaluated. Men and women aged ≥18 years may be eligible for study inclusion if he or she has had asymptomatic hyperuricemia (serum uric acid level, >7 mg/dL) on ≥2 isolated occasions, or been clinically diagnosed with

gout. People with neither of the preceding 2 criteria can be included as part of the control group.

The primary outcome measure is single-nucleotide polymorphism’s association with gout, hyperuricemia, and xanthine oxidase inhibitor doses needed to reach a goal serum uric acid level of <6 mg/dL, during a 2-year time frame. Other outcome measures are determining the frequency of single-nucleotide polymorphisms tested during that same time frame, as well as the relationship of xanthine oxidase singlenucleotide polymorphism 2107A>G and several hypoxanthine phosphoribosyltransferase 1 single-nucleo­ tide polymorphisms to hyperuricemia and gout.

The study expects to enroll 500 participants at the Keesler Medical Center, Biloxi, MS. For more information, contact Matthew B. Carroll, MD, at 228-376-3629 or matthew. carroll.1@us.af.mil. The NLM Identifier is NCT01830725.

3

Safety and Efficacy of Bucillamine Tablet Regimens To assess the safety and efficacy of 2 regimens of bucillamine 100-mg tablets, investigators are conducting a randomized, multicenter, phase 2, open-label activecomparator trial in patients with moderate-to-severe gout. Men and women aged 18 to 80 years may be eligible for enrollment if they meet other criteria, including a confirmed diagnosis of gout, ≥1 acute gouty arthritic attacks within the 12 months prior to study randomization, and no contraindication to colchicine.

Patients in this study will be randomized to receive bucillamine 900

CLINICAL TRIALS TRACKER

mg or 1800 mg during the course of 7 days, or colchicine 1.8 mg in 2 doses, 1 hour apart. Composite measurement of adverse events, physical examinations, electrocardiograms, vital signs, clinical laboratory evaluations, medical history, and/or prior or simultaneous medications are the primary outcomes of interest, as well as a ≥50% reduction in target joint pain score from baseline without use of the rescue drug.

The estimated number of patients to be enrolled in this trial is 66, at West Coast Research, San Ramon, CA, and Texas Physicians Medical Research Group, Arlington, TX. For more information, contact Revive Therapeutics Ltd, at 888-454-2565 or clinical@revivethera.com. The NLM Identifier is NCT02330796.

4

Assessing the Effect of a High Zone Tolerizing Regimen of Pegloticase Researchers are conducting an exploratory, open-label, multicenter study evaluating the effectiveness of a high zone tolerance regimen of pegloticase on response therapy in adult patients with refractory gout who are hyperuricemic. Men and women aged ≥18 years with chronic gout that is refractory to conventional therapy, who are of non-childbearing potential, may be eligible for enrollment if other criteria are met.

Patients will receive a tolerizing dose of pegloticase 8 mg intravenously each week for the first 3 weeks of dosing, followed by an 8-mg intravenous dose administered every 2 weeks for a total of 10 doses. The primary outcome measure is the responder rate for patients with refractory gout in the experimental group from baseline to 17 weeks. During that time frame, the investigators will also be evaluating several secondary measures, including changes in serum uric acid level from baseline to week 17, as well as the proportion of patients with serum uric acid level

<5 mg/dL at 17 weeks.

Approximately 20 patients will be recruited in the study at multiple locations across the United States.

For more information, contact Maggie Pugh, MS, at 404-892-7002 or mpugh@ind2results.com. The NLM Identifier is NCT02598596.

5

Cardiovascular Safety of Febuxostat and Allopurinol As part of this study, investigators are evaluating the cardiovascular safety of febuxostat and allopurinol in patients with gout and cardiovascular comorbidities. Men and women aged ≥50 years may be eligible for study enrollment if they meet several other criteria, including having a history of myocardial infarction, hospitalization for unstable angina, cardiac or cerebrovascular revascularization, and stroke.

The primary outcome measure is the first incidence of an event from the predefined Major Adverse Cardiovascular Events composite.

Patients in the experimental group will receive febuxostat 40 mg or 80 mg, depending on serum uric acid levels, whereas patients in the control group will receive allopurinol 200 mg to 600 mg, depending on their renal function. Both arms will receive treatment orally via capsules once daily for ≤60 months. The primary outcome measure is the first incidence of an event from the predefined Major Adverse Cardiovas­ cular Events composite. Secondary outcomes of interest include the first time any Antiplatelet Trialists’ Col-

laboration events or cardiovascular deaths occur.

An estimated 7500 people are being enrolled in this study at multiple sites across the United States. For more information, contact the Takeda Study Registration Call Center at 888-361-3630 or ctgovinfo@goutstu dynow.com. The NLM Identifier is NCT01101035.

6

Using Febuxostat to Counteract Metabolic Syndrome in Patients with Gout Researchers are conducting a phase 4, interventional, open-label, safety and efficacy study to evaluate whether febuxostat can improve insulin resistance and other aspects of metabolic syndrome—including high blood pressure—by lowering the uric acid level of patients with gout and hyperuricemia. Men and women aged >21 years may be eligible for inclusion if other criteria are met. Eligible patients also need to be diagnosed with gout and have serum uric acid levels of >7.0 mg/dL and >6.0 mg/dL in men and women, respectively.

For 6 months, patients in the experimental group will receive a 40mg febuxostat tablet once daily.

The primary end point of the trial is insulin sensitivity at 6 months; secondary outcome measures are ambulatory blood pressure, fasting urine pH, and fasting serum glucose, triglycerides, and high-density lipoprotein cholesterol.

An estimated 30 patients are being enrolled in the study at The University of Texas Southwestern Medical Center, Dallas. For more information, contact Naim M. Maalouf, MD, at 214-648-2954 or naim.maalouf@ut southwestern.edu. The NLM Identifier is NCT01654276.

7

Efficacy and Timing of Allopurinol Administration to Lower Uric Acid Levels In this phase 4, open-label, interContinued on page 22

CLINICAL TRIALS TRACKER

Select Ongoing Clinical Trials Currently... Continued from page 21 ventional efficacy study, investigators are assessing whether administering allopurinol after dialysis is more efficacious than giving it beforehand to lower uric acid levels in patients with gout who have renal insufficiency.

Men and women who receive chronic treatments of hemodialysis, and have taken allopurinol for ≥1 months may be eligible for study inclusion if other criteria are met.

As part of this trial, eligible patients will receive allopurinol at bedtime at the same dosage that was previously prescribed. Change in uric acid levels from baseline to 6 weeks is the primary outcome measure.

Fifty patients will be enrolled in the trial at Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada. For more information, contact Michel Vallée, MD, PhD, at mval lee@ssss.gouv.qc.ca. The NLM Identifier is NCT02477488.

8

Rheumatology Informatics System for Effectiveness (RISE) Registry This patient registry seeks to collect data from patients with gout, osteoarthritis, and rheumatoid arthritis to improve several aspects of care, including quality reporting and drug safety. Men and women aged ≥18 years may be eligible for inclusion if other criteria are met, including diagnosis of 1 of these 3 conditions.

The Rheumatology Informatics System for Effectiveness (RISE) registry will provide patients with quality-enhancing activities to improve patient outcomes and population management. The primary outcome measure of interest is adequately controlled high blood pressure during a 1-year time span.

The registry will include a large number of patients, and be conducted by the American College of

Rheumatology, Atlanta, GA. For more information, contact Melissa D. Francisco at 404-633-3777 (ext.

102) or mfrancisco@rheumatology. org. The NLM Identifier is NCT02230943.

9

Using Elastography to Determine the Outcome of Patients with Gouty Arthritis As part of this observational, case-only, prospective study, investigators are seeking to evaluate changes in patients with gouty arthritis who are taking—or about to begin taking—urate-lowering therapies.

Men and women aged 18 through 99

In this observational, case-only, prospective study, investigators are seeking to evaluate changes in patients with gouty arthritis who are taking—or about to begin taking—uratelowering therapies. years may be eligible for inclusion in the trial if other criteria are met, including having gouty arthritis, as determined by the American College of Rheumatology 1977 classification, and having a single, palpable tophus detectable through one of several clinical parameters.

The primary outcome measure is changes observed in gouty arthritis via elastography over a 1-year time frame. Approximately 10 patients will be enrolled in this trial at the Center for Rheumatology and Bone Research, Wheaton, MA. For more information, contact Theresa

Bass-Goldman at 301-942-6610 or tbgoldman@arapc.com. The NLM Identifier is NCT02471261.

10

Combination Therapy with Pegsiticase in Patients with Elevated Uric Acid Levels Investigators are conducting a phase 1, randomized, safety and efficacy study to evaluate the safety and pharmacodynamics of SEL-212 use among patients with elevated blood uric acid levels. Men and women aged 21 to 70 years may be eligible for study inclusion if other criteria are met; these include serum uric acid levels ≥6 mg/dL in patients with or without a history of gout, uric acid level–lowering therapy with allopurinol, febuxostat, or probenecid, as well as adequate venous access and the ability to receive intravenous therapy.

In the first part of the study, patients will receive 1 intravenous dose of a nonparticle containing rapamycin (SEL-110). Safety, pharmacokinetics, pharmacodynamics, and immunogenicity will then be evaluated following a single intravenous dose of SEL-212, and SEL-037 (pegsiticase) plus SEL-110. The primary outcome measurements of interest are the safety and tolerability of the intravenous injections, assessed via frequency and severity of drug-related adverse events. Secondary outcomes of interest are the pharmacokinetics of SEL-110 in 30 days, and the pharmacokinetics, pharmacodynamics, and immunogenicity of SEL037, within the same time frame.

An estimated 53 patients are being enrolled in this trial at locations in Arkansas, Maryland, Pennsylvania, Minnesota, and Florida. For more information, contact Earl Sands, MD, at 617-923-1400 (ext. 8122) or ssands@selectabio.com. The NLM Identifier is NCT02648269. n