UPM April 2014

Urology Practice Management ™

PROCESS IMPROVEMENTS TO ENHANCE PATIENT CARE™

www.UroPracticeManagement.com

APRIL 2014

Team Stress: Controlling Its Impact on Your Bottom Line

By Sandra Paton

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he uncertainty of the current healthcare environment has become a cause of undue stress.

Although stress can have a positive im­pact on individuals Sarah J. Holt, PhD, and organizations, it FACMPE most often wields a negative effect. According to the American Institute of Stress (www.stress. org/workplace-stress/), up to 60% of absenteeism in the workplace has been attributed to stress. Downsizing, mergers, increased regulatory requirements, and increased work demands all contribute to workplace stress. Sarah J. Holt, PhD, FACMPE, administrator of Cape Girardeau Doctors’ Park, Cape Girardeau, MO, recently Continued on page 8

VOLUME 3 • NUMBER 2

The Unintended Benefits of Good Medicine

By Rick Janss, MBA, CMPE, Practice Administrator, Clinical Urology Associates, Gadsden, AL

T

estosterone is commonly prescribed for men suffering from hypogonadism. While most men produce testosterone naturally, their production often declines with age, leading to symptoms of fatigue, loss of appetite, and reduced sex drive.

Like most urology practices, we have

offered several options for men suffering from this condition. Our physicians will routinely prescribe testosterone therapy in the form of gels, pellets, or 2-week injections. Recently, we stopped allowing patients to self-administer shots, Continued on page 4

ICD-10 Delayed, SGR Patched for at Least 1 Year

By Frederique H. Evans, MBS

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s medical practices planned for International Classification of Diseases (ICD)-10 and the im-­ plementation of new diagnostic codes on October 1, 2014, practice administrators took steps to ensure that physicians and staff would be prepared. With the clock ticking down, staff had been

signing up for training seminars, bringing experts onsite, and allowing extra coding time in the schedule, all to be sure that new codes would be entered accurately into patient claims beginning October 1.

However, with a congressional vote Continued on page 6

T EN EM : 3 of G A ks st N n Stine Be..11 A .

M k Plake thtion

©2014 Engage Healthcare Communications, LLC

H 1 a a LT r 40 o M Situ EA ou s t d W YWay A Ba

In This Issue

PUBLISHING STAFF Senior Vice President/Group Publisher Nicholas Englezos nenglezos@the-lynx-group.com Vice President, Director of Sales & Marketing Joe Chanley jchanley@the-lynx-group.com Publisher Cristopher Pires cpires@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 Editorial Assistants Jennifer Brandt Cara Guglielmon Production Manager Marie RS Borrelli The Lynx Group President/CEO Brian Tyburski Chief Operating Officer Pam Rattananont Ferris Vice President of Finance Andrea Kelly Human Resources Jennine Leale Associate Director, Content Strategy & Development John Welz Associate Editorial Director, Projects Division Terri Moore Director, Quality Control Barbara Marino Quality Control Assistant Theresa Salerno Director, Production & Manufacturing Alaina Pede Director, Creative & Design Robyn Jacobs Creative & Design Assistant Lora LaRocca Director, Digital Media Anthony Romano Web Content Managers David Maldonado Anthony Trevean Digital Programmer Michael Amundsen Meeting & Events Planner Linda Sangenito Senior Project Managers Andrea Boylston Jini Gopalaswamy Project Coordinators Jackie Luma Deanna Martinez IT Specialist Carlton Hurdle Executive Administrator Rachael Baranoski Office Coordinator Robert Sorensen Engage Healthcare Communications 1249 South River Road - Ste 202A Cranbury, NJ 08512 phone: 732-992-1880 fax: 732-992-1881

FEATURES The Unintended Benefits of Good Medicine…................................................1

By Rick Janss, MBA, CMPE

ICD-10 Delayed, SGR Patched for at Least 1 Year….........................................1

By Frederique H. Evans, MBS

Team Stress: Controlling Its Impact on Your Bottom Line...................................1

By Sandra Paton

AUA Practice Manager’s Network a Resource for Urology Practices............7

By Rosemary Frei, MSc

Your 401(k) Plan Stinks: 3 Ways to Make the Best of a Bad Situation…........11

By W. Ben Utley, CFP®; and Lawrence B. Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF

Denials Management Isn’t Just Your Billing Department’s Concern............13

By Matt Terry, MBA, BSRT(R)(T); and Candy Luna

7.1 Million Enrolled by March 31 Deadline: AMA Offers Physician Resources, Works to Ease Transition................................................................14

By Rosemary Frei, MSc

Xiaflex (Collagenase Clostridium Histolyticum), First Drug Approved by the FDA for Peyronie’s Disease...................................................................17

By Loretta Fala, Medical Writer

EDITORIAL ADVISORY BOARD Neil Baum, MD Practicing Urologist New Orleans, LA Cheris Craig, MBA, CMPE Chief Administrative Officer Urology of Greater Atlanta, LLC Atlanta, GA Rick Janss, MBA, CMPE Practice Administrator Clinical Urology Associates Gadsden, AL

John McMann, MS Administrator Advanced Urology Specialists, LLC Oxford, FL

James A. Sylora, MD Urologist AUS–Midwest Urology Evergreen Park, IL

Jonathan Oppenheimer, MD, FCAP Medical Director, Chief Pathologist Oppenheimer Urologic Reference Laboratory Nashville, TN

Sean M. Weiss, CCP-P, CCA-P, ACS-EM, CPC, CPC-P Vice President & Chief Compliance Officer DecisionHealth/ Professional Services Gaithersburg, MD

MISSION STATEMENT Urology 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 urology patients deserve, providers must master the ever-changing business of urology. Urology Practice Management offers process solutions for members of the urology care team—medical, surgical, and radiation urologists, 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.

Urology Practice Management™, ISSN (requested), is published 6 times a year by Engage Healthcare Communications, LLC, 1249 South River Road, Cranbury, NJ 08512. Copyright ©2014 by Engage Healthcare Communications, LLC. All rights reserved. Urology 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 Urology 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 Urology 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, Urology Practice Management™, 1249 South River Road, 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.

April 2014

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Best Practices

The Unintended Benefits of Good…Continued from the cover

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however, and have instead required them to come in every 2 weeks for an injection. This recent policy change, instituted for the benefit of our patients, has also helped our practice in several unexpected ways.

The move to bring our testosterone injections in-house was initially precipitated by concerns that certain patients (eg, powerlifters) may be abusing the therapy, or could potentially abuse it in the future. Our physicians had noticed that increasing numbers of our patient population had low testosterone levels despite being otherwise healthy and fit. One of the side effects of steroid abuse is that the body may quit producing natural testosterone. Abusers seek testosterone because it helps build muscle mass; it is a controlled substance, and we did not want our patients abusing it.

Administering testosterone shots in-house has alleviated that concern; we check patients’ testosterone levels every few months to ensure that everything is fine. Since we are able to regularly monitor patients’ blood levels, we can provide better care and adjust doses as needed based on timely laboratory results. In other words, we have improved how we practice medicine. We expected some flak from a few of the patients who liked administering the medicine themselves, so we prepared the staff for some rough discussions. We were fearful that patients would find the new way inconvenient.

We also decided it would be best to dedicate a nurse to managing the patients; this streamlined our physicians’ schedules, but also allowed patients to develop a trusting relationship with a consistent care provider. The nurse now schedules patients’ appointments, administers

injections, and bills them out. It is like having a men’s health clinic within the practice. We initiated this policy to alleviate concerns about abuse and provide better patient care; in short, it was a sensible plan. We did not, however, ex­pect what was coming next.

In an effort to boost the number of patients coming to the practice, we approached local primary care physicians and explained that we would be happy to administer injections for their patients with low

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Since we are able to regularly monitor patients’ blood levels, we can provide better care and adjust doses as needed based on timely laboratory results.

testosterone and free the primary care physicians from that burden.

We did not think the physicians would mind, because we were not a competitive threat. Every single one of the physicians we approached was grateful. They complained that it was difficult to see all of their normal patients and monitor this patient set as well. In addition, urologists have a great understanding of proper dosing and appropriate follow-up care. It was a win–win for the primary care physicians and for us.

Here is the biggest kicker: I know we are not the only practice in America that has past due balances; I will freely admit that we do. We

April 2014

are also constantly faced with delinquent patients, who, in urgent circumstances, show up in the emergency department for care. We then become responsible for a consult and subsequent follow-up treatment. This leads to balances that are seldom paid. However, with our new policy in place, we found that we now have a little leverage.

Patients receiving testosterone therapy are advised at the outset that all balances must be paid in full prior to their next visit. We do not allow patients to receive injections until their balances are paid. (Of course, we make exceptions for those patients who are earnestly making payments, facing extreme hardships, or dealing with extenuating circumstances.) We have found that stating this policy clearly and up-front motivates many patients to keep their accounts current rather than face the possibility of low testosterone. Our front desk staff is also repeatedly amazed that patients who have been difficult in the past are now compliant and understanding.

The end results of this new policy change are positive: primary care physicians are ecstatic that we are removing a burden from them, our patients are receiving better treatment with more follow-up, and, finally, patients are paying their balances, which decreases accounts receivable. A change that was brought about to combat abuse and improve patient care ended up bringing with it a substantial profit.

It has been a true win­–win–win situation for all. l Rick Janss, MBA, CMPE, is a member of the Urology Practice Management editorial board. A former financial planner, he is currently the practice administrator for Clinical Urology Associates, a busy private

Urology Practice Management ™

PROCESS IMPROVEMENTS TO ENHANCE PATIENT CARE™

MAY 2013

www.UroPracticeManagement.com

VOLUME 2 • NUMBER 1

Call for Papers

Transitioning to ICD-10 Exploring Men’s

By Susanne Talebian, CHBC, RMM, CMOM, CPC-I, CPC, CUA, CCS-P, PCS Willingness to Pay Certified Healthcare Business Consultant, American Health Information for Prostate Cancer Management Association—AHIMA Certified ICD-10-CM/PCS Trainer n October 1, 2014, the United is less than 17 months away, during which Screening to Avoid States will adopt the International several phases of implementation must be Classification of Disease, Tenth completed. The timeline for implementUnnecessary Biopsys Revision, Clinical Modification/Procedure Cod- ing the code sets is divided into 4 phases: and Treatment ing System (ICD-10-CM/PCS), 1 year later Phase 1: Impact Assessment, first quarter

By Rosemary Frei, MSc

D

DoO you have a practice management story to share than we had initially reported in Urology Practice Management in September 2012.

The reprieve, although welcome to many,

2009 through second quarter 2012; Phase 2: Preparing for Implementation, first quarter 2012 through second quarter 2014; Phase 3:

?

utch researchers have peered Continued on page 10 into the minds and wallets of a group of men aged 55 to 75 years to determine what they are willing to trade for a reduced risk of prostate cancer–related death or to avoid unnecessary procedures and treatment.

Men with more education had a lower probability of opting for prostate cancer screening. Furthermore, the men were

By Gena Cook willing to lose 2% of risk reduction in Founder and Chief Executive Officer Navigating Cancer, a leading provider mortality related to prostate cancer, of oncology-specific patient portals or to pay, on average, €188 (in 2010 In your background a urology practice it’s likely there’s one stablishing a as patient-centered and Health manager, Information Technology euros—equivalent to $245 in 2010 US approach is rapidly becoming a core for Economic and Clinical Health dollars) annually, for a 10% reduced risk business experience—and maybe more—that practice managers across requirement in US medical prac- (HITECH) requirements all have comof unnecessary biopsy or treatment. tices.

Medical home models, accountponents of engaging patients in their “Physicians should be aware that men, the nation would want to read about. able care organization (ACO) models, care. To incorporate a patient-centered Continued on page 8

Implementing a Patient Portal in Your Urology Practice to Provide Patient-Centered Care

E

Continued on page 19

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 H LT business and/or practice medicine, or how you successfully integrated A E er H ancillary products and services into your practice as generator. c E a nrevenue 6 O

PR ©2013 Engage Healthcare Communications, LLC

Send us your ideas!

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a 1 C ... te ew ts a rvi o e Pr Ov

A

ST

Submit a 600- to 1500-word original article to Urology Practice Management, that your fellow practice managers will want to read.

Submit to: editorial@engagehc.com UPM_2614

Legislative Update

ICD-10 Delayed, SGR Patched…Continued from the cover in late March on bill H.R. 4302, Protecting Access to Medicare Act of 2014,1 and a sweep of the presidential pen, implementation of the new codes has been delayed for at least 1 year, caught up in legislation that also delayed cuts to physician reimbursements through Medicare’s sustainable growth rate (SGR) payment formula. While the legislative action avoided a nearly 24% reduction in physician payments through the SGR formula, many physician groups opposed this “patch,” instead favoring a reform of the Medicare reimbursement system.2 Since its deployment, 16 short-term annual fixes have been made to SGR to prevent payment cuts.3 “In the face of broad opposition from medical organizations against simply defaulting to another shortterm patch, the House relied on procedural maneuvering to quickly approve the 12-month proposal on a voice vote. The Senate followed suit…. Both chambers failed to seize a historic opportunity,” Ardis Dee Hoven, MD, President of the American Medical Association (AMA), said in a statement. “While we are disappointed that the fight for SGR repeal must continue, we are in a far better place to advance reform than we were a year ago. Rest assured that the AMA will continue to press for the changes we need to ensure our practices are sustainable and our patients have reliable access to the care they need.”4 Earlier this year, a bipartisan group of House and Senate lawmakers proposed the SGR Repeal and Medicare Provider Payment Modernization Act,5 which intended to permanently repeal Medicare’s SGR formula for physician payments and replace it with annual increases of 0.5% between 2014 and 2018. These increases would be maintained through 2023 so that physicians

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have time to receive additional payments through a merit-based incentive payment system. The proposed act would apply to clinical nurse specialists, nurse practitioners, and physicians of medicine or osteopathy. A summary of the legislation suggests that the new payment system would encourage care coordination initiatives for patients with chronic illnesses. It would also require electronic health records to be interoperable by 2017.

In addition to the temporary SGR patch, the bill also extends the geographic practice cost index floor through April 1, 2015, the therapy cap exceptions process through March 15, 2015, and increased inpatient hospital payment adjustment for certain low-volume hospitals starting on April 1, 2015, for FY2016 and subsequent tax years.1 The bill also extends the Medicare-dependent hospital program through March 31, 2015, and extends authority to renew a reasonable cost-reimbursement contract with a health maintenance organization and competitive medical plan through December 31, 2016.

In addition, the bill amends the Medicare Improvements for Patients and Providers Act of 2008, to extend through March 31, 2015, the funding of various programs, including agencies on aging and the contract with the National Center for Benefits Outreach and Enrollment. It also authorizes the Secretary of Health & Human Services to continue through June 2015, with a specified limitation, certain medical review activities related to the 2 Midnight Rule.

The latter is a controversial rule that allows Medicare coverage of only hospital stays for which a physician admits to a hospital a beneficiary expected to require care that crosses 2 midnights, but generally denies coverage of care expected to require

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April 2014

less than a 2 midnight stay.

The full list of amendments can be found on Congress.gov.

What the Bill Means for You This extension, which the Con­ gressional Budget Office estimates will add as much as $180 billion to the federal deficit,6 has left both lawmakers and healthcare professionals alike with many unanswered questions.7 In particular, the Cen­ ters for Medicare & Medicaid Services wonders whether October 1, 2015, will become the new deadline; whether the agency will allow organizations that are ready to implement ICD-10 to do so voluntarily; and whether the agency will scrap ICD-10 altogether, and instead wait for ICD-11, which is due to be released in 2017. l References

1. Congress.gov. H.R. 4302 – Protecting Access to Medicare Act of 2014. http://beta.congress.gov/bill/ 113th-congress/house-bill/4302. Accessed April 9, 2014.

2. Pittman D. SGR, ICD-10 Delay Ready to Be Signed Into Law. MedPage Today. http://www.med pagetoday.com/PublicHealthPolicy/Medicare/45043.

Published March 31, 2014. Accessed April 14, 2014.

3. MacDonald I. Senate Oks SRG patch, delays ICD-10. Fierce Healthcare. http://www.fierce healthcare.com/story/senate-oks-sgr-patch-delaysicd-10/2014-03-31. Published March 31, 2014.

Accessed April 10, 2014.

4. AMA Wire. Why permanent SGR repeal lost to another temporary payment patch. http://www.ama-as sn.org/ama/pub/ama-wire/ama-wire.page?plckControl ler=Blog&plckBlogPage=BlogViewPost&UID=e38c f47a-fc5f-473b-9234-c9e714c1c8f0&plckPos tId=Blog%3ae38cf47a-fc5f-473b-9234-c9e714c 1c8f0Post%3aaf492466-72dd-449d-a053-8720eac adb3f&plckScript=blogScript&plckElementId=blog Dest#.U0wBUPldV40. Published April 1, 2014.

Accessed April 14, 2014.

5. Lawmakers announce bipartisan deal to repeal, replace SGR. www.californiahealthline.org/articles/ 2014/2/7/lawmakers-announce-bipartisan-deal-torepeal-replace-sgr. Published February 7, 2014.

Accessed April 10, 2014.

6. The United States Senate Committee on Finance.

Hatch calls for return to bipartisan, bicameral talks to advance bill to permanently fix broken SGR formula. http://www.finance.senate.gov/newsroom/ranking/ release/?id=38523414-4dd3-478e-945a-111ecc1ca5bf.

Published March 31, 2014. Accessed April 10, 2014.

7. Carlson J, Robeneznieks A. ICD-10 delay puts pressure on CMS for answers. Modern Healthcare. www.modernhealthcare.com/article/20140401/ NEWS/304019940/icd-10-delay-puts-pressure-oncms-for-answers. Published April 1, 2014. Accessed April 10, 2014.

Practice Administration

AUA Practice Managers’ Network a Resource for Urology Practices

By Rosemary Frei, MSc

A

s the healthcare landscape continues to evolve, managers and administrators of urology practices have a constant they can rely on. For 14 years, the Practice Managers’ Network (PMN), a resource offered through the American Uro­ logical Association (AUA), has offered support to management teams across its spectrum of membership.

Rick Rutherford, Director of Practice Management for the AUA, started the AUA PMN when he was asked by the association to help provide services to practices of 1 or 2 urologists. From there, PMN’s listserv was born, among other services for urologists, practice managers, clinic chief executive officers, and others who need to keep up with the constant changes to the business side of urology.

“People who subscribe to the PMN can send questions to the listserv 24 hours a day, and they can also provide responses to other people’s questions,” said Mr Rutherford.

“Just some of the things that have been discussed lately are how people do their accounting and payroll— whether they use a CPA [certified public accountant], and someone external or internal.…We prohibit users from discussing their actual fees, for antitrust reasons, but beyond that, they share a lot of information: everything from where the cheapest place to buy medical supplies might be to where to get prostate cancer drugs when they’re in short supply.”

Richard A. Schoor, MD, PC, an independent urologist in Smith­ town, NY, and the author of “The In­depend­ent Urologist” blog, credits the listserv as being a valuable source for practice management information for urologists.

“I opened my practice in 2006 and didn’t find out about the listserv until 2007. And there were lots of mistakes I wouldn’t have made if I’d known about the listserv to start with,” Dr Schoor told Urology Practice Management. “There are hundreds of decisions that need to be made in starting a urology clinic, and it would have gone a lot smoother if I had been on the listserv from day one. Once I got on the listserv, everything’s gone smoothly.”

Mr Rutherford and his staff also send out the PMN E-News every month to subscribers, providing a summary of the news that urologists can use. For example, the March 2014 edition alerted urologists to the deadlines for registering for the AUA’s coding seminars and the opportunity to participate in the AUA Quality Registry. There was also a regular feature, the ICD-10 Coding Challenge, providing support as practices at that time prepared for an expected transition to the International Classification of Diseases (ICD)-10. Mr Rutherford introduced this in January 2014 as an adjunct to the online ICD-10 basic training that the AUA launch­ ed in 2013.

Members also have access to the AUA Policy & Advocacy Brief, a newsletter that comes out via e-mail twice monthly. A recent edition focused on ICD-10, and other topics covered range from sustainable growth rate (SGR) reform to features of the Affordable Care Act. In addition, the AUA’s Coding Hotline is staffed by professional coders who help urologists to ascribe codes to complicated surgical procedures, or provide assistance when a claim has been denied because of improper coding.

April 2014

Janet F. Bernstein, Practice Man­ ager, New York Urological Associates PC, New York, also attests to the positive impact of the features of membership in PMN. “I don’t know how anyone practicing medicine today can keep up with all the regulatory changes without a partner. For our practice, it is the AUA Practice Management Network,” Ms Bernstein wrote in an e-mail to Urology Practice Manage­ ment. “We relied on the network for understanding CMS [Centers for Medicare & Medicaid Services]’s requirements for PQRS [Physician Quality Reporting System], Mean­ ingful Use, ICD-10, CPT [Current Procedural Terminology] coding issues—just to mention a few issues.

This is in addition to their ongoing educational symposiums for practice management.”

Mr Rutherford and colleagues are also available to provide other forms of support, such as an audit service in which they review and report on coding errors from the previous few months; the cost is determined by the number of providers reviewed.

Other educational offerings and support include webinars as well as the AUA’s annual meeting, which will be held in Orlando, FL, May 16 to 21, 2014. A Practice Man­agement Conference is scheduled for the first 2 days of the meeting and will include topics covering Meaningful Use 2, maximizing billing data, and establishing an effective patient portal.

For more information on PMN, visit www.auanet.org/resources/pmnpractice-managers-network-pmn.cfm.

For more information on the upcoming AUA annual meeting, visit www. aua2014.org. l

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Practice Administration

Team Stress: Controlling Its Impact on…Continued from the cover shared with practice managers the effect of stress on teams and the impact it has on the financial bottom line.

Dr Holt began by distinguishing between challenges and stressors.

Some people thrive on challenges.

Whereas challenges may be appropriate to a person’s skill level, ability, and knowledge, stress may result when an employee does not have the resources or skills to accomplish a task they have been given.

Certainly, people react differently to stress, based on their personalities and emotional intelligence.

There are, however, certain traits that are conducive to stress.

Conscientious employees, she noted, are at one end of the spectrum, while disorganized employees are at the other end. Those plagued by perfectionism can never get anything done, because they seek to attain the often unattainable.

Emotionally stable employees are often levelheaded and resilient.

They might be cool in the face of stress, while anxious, fidgety employees prove fragile. Others might have to walk on eggshells around them. Most of us, she explained, are somewhere in the middle, and once in a while fall out of balance. People who are open are adaptable to change and welcome it. They rally in finding new ways to do things and seek the “better way.”

They are apt to be creative and curious. Others are fearful. The slightest change upsets them and sends them into retreat.

Some employees are agreeable.

Others are disagreeable. Although practices might hope that everyone in their employ is 100% agreeable, they would find that these employees are of little value. If a colleague agrees with everything you suggest, you might as well be in an echo chamber. Dr Holt noted that there

is no value in exchanges with overly agreeable colleagues. On the other hand, the colleague who is disagreeable for the sake of being disagreeable can become a serious annoyance and someone you would seek to avoid. “What we need on the agreeable spectrum is something closer to the middle. We want somebody with enough conviction to say, ‘Can we think about that for a minute? Can we discuss it?’

Because if they can’t and won’t, they will never serve as assets to your team,” she observed.

Introversion and extroversion are other traits that you need to distin-

Although stress can have a positive impact on individuals and organizations, it most often wields a negative effect.

guish. Introverts might have excellent ideas, but might require that you draw ideas from them. “The truth is, the more you know about each person on your team, the more able you will be to create a successful, high-functioning team,” Dr Holt offered. All of the traits mentioned are likely to be found in some members of your team.

Stressors When asked to identify specific stressors at work, employees mentioned tension with coworkers, excessive work overload, role conflict, bad task design, and management style.

“The number one reason why people leave organizations is bad management,” Dr Holt noted. “Good employ-

ees seek good management. When they are faced with bad management, it stresses them to the point where they cannot take it anymore and often leave the organization.”

Other negative stressors include lack of support, lack of authority for work roles, lack of direction, career concerns, unpleasant physical working conditions, impossible deadlines, demeaning colleagues, and being on call 24/7. When an employee feels they are not getting sufficient support from their coworkers or their supervisors, they feel underappreciated. When workers are given broad responsibilities without sufficient authority to achieve those tasks, their burdens increase. Not knowing what to do and not being supported in a decision can cause tension. Do I follow the needs of the organization?

What is best for the patient? Should I do this to make more money?

Sometimes we have to struggle to figure out what to do, Dr Holt noted. Career concerns might arise when someone realizes there is no room for advancement in an organization. Other issues arise from unpleasant working conditions, such as being stuck in a cubicle with no windows. Impossible deadlines are another real problem. A colleague who took work home and stayed up all night to get a task done might feel underappreciated when their work was met without appropriate approbation.

Demeaning and abusive colleagues can create a hostile work environment. It is important to pay attention and be alert to situations where abuse is not readily apparent.

“Some abuse occurs on a subtle level. One should do everything possible to prevent abusive behavior and potential lawsuits that might arise from it,” Dr Holt said.

Being unable to unplug from work is a huge problem. “Getting a Continued on page 10

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Practice Administration

Team Stress: Controlling Its Impact on…Continued from page 8 call from the office at night while at home sends a message to your family that they come in second. This creates stress for you and your family,” Dr Holt warned. Related issues occur when you are continually tired and complain of being exhausted and unable to sleep. The next thing you notice is that you function below par and just do not care anymore. Be aware that burnout is imminent.

Arbitrary management decisions that do not make apparent sense are often difficult to complete. When a seemingly senseless edict comes down, workers might ask: • “What is this all about?”

• “Who decided this?”

• “Why were we cut out of the loop?”

• “Why didn’t we have some say in this decision?”

Ever-rising expectations also add an undue amount of stress. If the bar keeps getting higher and higher with less and less downtime, employees might have no opportunity to take a break or a breath before the next pile of work arrives.

Stress often manifests physically, but sometimes also psychologically or behaviorally. These include sleeping problems, stomach upset, hypertension, depression, anxiety, cognitive difficulties, lack of judgment, inability to make decisions, disinterest, and isolation (eg, having lunch in the car and not with the group).

The Team A good team thinks, acts, and feels together. Members of a good team trust each other and perform like one—“just like a good family,” observed Dr Holt. Teams are essential, but they are also fragile. You might put together an excellent, high-functioning team, only to see it dissolve in an instant. Like all

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families, problems arise. “When teams are put under a tremendous amount of stress, they soon lose their focus on ‘we’ and narrow their focus onto ‘I,’” she said. The thinking together stops, performance becomes independent, and the team deteriorates. Without the right leadership, the team will remain uncoordinated and cease productivity.

When a team falls apart, manage-

“The number one reason why people leave organizations is bad management.”

—Sarah J. Holt, PhD, FACMPE

ment might feel the need to micromanage only to deteriorate the trust of team members further. “If you don’t trust me to get the work done, then I don’t trust you.”

The US Bureau of Labor Statistics found that when employees leave work because of stress, they typically stay away from work for a period of 20 days. “Unfortunately, when 1 person vacates his or her desk, someone else must fill in. And someone else must fill in for them and so on down the line,” Dr Holt explained. She described how as many as 4 or 5 workers might be displaced, possibly for a period of 20 days, preventing efficient operation.

Management Must Lead The fact of the matter is that “management has the authority and the responsibility to make things in the workplace function differently and well,” Dr Holt reminded the audience. One of the things management must do is “lead by exam-

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April 2014

ple.” She urged managers to look on the bright side, look for things to be grateful about, and focus or refocus on team building. Although she noted that managers might not be able to change what is happening in the C-suite, they can change how their own department functions and reacts to it. Working together, bringing relief to each other, and renewing the focus on your team can make all the difference. “Strive to be a good leader. And strive to address problems in a way that will be seen as appropriate. This is a tough call,” Dr Holt noted, “but your efforts will be appreciated if you attempt to be genuine. Dis­ ingenuousness does not work.”

Managers must be careful not to ignore the signs and symptoms of stress. And they might consider stress reduction programs, either formal or informal. Dr Holt recommended planting the seeds for instituting a stress reduction program in the future if having one now is not possible.

Managers should attempt to clarify who is responsible for each operation and then hold that person accountable. “When a team member has not been accountable, the leader must step into the role—in private. This is how trust is built,” said Dr Holt.

When trust is broken—and this will happen—the manager must make the effort to repair it. It will be important to realign your purpose, encourage professionalism, and develop an alternative course of action.

Ul­-timately, you must manage yourself—possibly a lifelong goal. Dr Holt urged practice managers to admit when they have made a mistake.

“When you identify that there is a problem with the team, you must decide what the outcome should be.

When you intervene, be intentional—determine whether you should Continued on page 12

Wealth Management With Lawrence B. Keller

Your 401(k) Plan Stinks: 3 Ways to Make the Best of a Bad Situation

By W. Ben Utley, CFP®; and Lawrence B. Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF

W

e see a number of changes phy­sicians might make to improve their financial security, but 1 item is usually beyond their control: the 401(k) plan. Un­less you are self-employed, there is practically nothing you can do about your 401(k)’s underwhelming investment options, ridiculously low con­­tri­­­bution limits, or perverse tax consequences.

If your 401(k) is your main (or maybe your only) investment vehicle for retirement, we have good news for you: It is possible to work around your 401(k) plan’s limitations so you can get back on track toward retirement.

Low Limits Many physicians operate under the mistaken belief that, if they max out their 401(k) plan contributions, they will be all set for retirement. But did you know that the maximum amount of money you can elect to defer into your 401(k) this year is only $17,500 ($23,000 if you will be aged 50 years or older by December 31)? That’s roughly $1400 deducted from your paycheck each month ($1900 per month if you are aged 50 years or older).

Have you ever met a physician who could live well on $1400 a month? We haven’t. In fact, the physicians we serve are planning to spend more like $10,000 per month in retirement, and that’s after-tax. It would take a miraculously high rate of return to turn $1400 per month pre-tax into $10,000 per month after-tax, so many physicians are well on their way to a retirement disaster.

To improve your odds of reaching your retirement goal, you can save outside your 401(k) plan. Even if you cannot deduct the contributions you

make to a traditional IRA, you can still contribute $5500 this year ($6500 if you will be aged 50 years or older by December 31), and if you max out your own IRA, your spouse can also contribute up to $5500 to his or her IRA ($6500 if he or she W. Ben Utley

Unless you are selfemployed, there is practically nothing you can do about your 401(k)’s underwhelming investment options, ridiculously low contribution limits, or perverse tax consequences.

both your 401(k) plan provider and the investments offered inside your plan. Don’t believe it! We have found that busy managers may lack the time or expertise to make well-informed decisions regarding investment-related fees or available investment options. If your plan charges more than 50 basis points (0.50%) on top of mutual fund operating expenses, your plan’s costs are draining an unfair share of your retirement savings. To get this under control, you need to raise your voice, but be careful. We regularly see very expensive plans that persist simply because of office politics.

It’s more common to see an investment lineup consisting mostly, if not entirely, of actively managed mutual funds. This is a sign of ignorance on the part of your plan fiduciaries. At a time when most prudent investors recognize that passively managed index funds have been shown to have delivered better results at a lower cost than the average actively managed fund, there’s no good reason that your plan should continue to limit you to subpar investment options.

To work around these issues, look at your retirement investments holistically. Think about your 401(k) plan, your traditional IRAs, and your

will be aged 50 years or older by December 31) even if he or she is not earning an income. Depending upon your tax situation, it might also make sense to convert these contributions to a Roth IRA, doing what is known as a “backdoor” Roth IRA contribution. Once the money is in a Roth IRA, it can grow tax-free for the rest of your life. Of course, this still might not be enough to allow you to retire comfortably, so you should consider investments outside of your 401(k) plan and IRAs.

Underwhelming Options You probably haven’t read the fine print behind your 401(k) plan, but you are betting that your practice manager has carefully vetted

April 2014

Lawrence B. Keller

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Wealth Management

Your 401(k) Plan Stinks…Continued from page 11 after-tax accounts (mutual funds and brokerage accounts) as if they were all 1 “retirement portfolio.” Then use the least-bad investment options from your 401(k) and pair them with the best options available within other accounts that make up the balance of your portfolio.

Tax Time Bomb You already know that physicians pay more than their fair share of taxes. But did you know that you are probably setting yourself up to pay more taxes on your 401(k) than you really should? That’s right. There’s a perverse little wrinkle in the tax code that can turn your 401(k) plan into a tax time bomb.

To understand this trap, you need to know a little bit about how investments are taxed. Withdrawals from your 401(k) plan will be taxed at your marginal income tax rate, which may be as high as 39.6% for federal income tax. At the same time, capital gains and qualified dividends from mutual funds held in taxable accounts outside your 401(k) plan are taxed at a maximum federal rate of 23.8% (which is 20% plus the new 3.8% Medicare surtax).

This means that your 401(k) nearly doubles the tax rate you pay on capital gains and qualified income by

effectively converting these tax-favored returns into tax-trapped ordinary income. Consider holding equity mutual funds in a taxable account, or better yet, own them in your Roth IRA or the Roth subaccount of your 401(k), if you have one.

Even if you are stuck with a stinky 401(k) plan, you can still make the best of a bad situation.

If your 401(k) is a lousy place to stash your stock funds, what should you hold there instead? Consider lowgrowth, income-producing in­ vest­ ments, including bond funds and stable value funds. If you have an appetite for more aggressive fare, consider high-yield (“junk”) bond funds or emerging market bond funds. Outside your 401(k) plan, these investments may be taxed at your highest marginal rate, so it’s a good idea to protect their income by keeping it inside the tax shelter of your 401(k) plan.

Again, the best workaround for this tax trap is to view your entire retirement portfolio—including

your 401(k) plan, your IRAs, and your other accounts that are earmarked for retirement—as 1 portfolio. Choose to own the best investments in the accounts that make the most sense from the standpoint of expense, risk, return, and taxation.

Summary Even if you are stuck with a stinky 401(k) plan, you can still make the best of a bad situation. All you have to do is take a look at the big picture, think outside the box, and make smart moves to put yourself on track for a solid retirement. l W. Ben Utley, CFP®, is the lead advisor with Physician Family Financial Advisors, a fee-only financial planning firm helping doctors throughout the United States to save for college and invest for retirement. Contact him at 541-463-0899 or visit www.physician family.com.

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.

Team Stress: Controlling Its Impact on Your…Continued from page 10

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coach, counsel, or discipline. But act promptly before a problem becomes too big or too intense.”

In short: • Express gratitude • Celebrate small successes • Seek honest feedback • Define problems • Attempt to learn the scope of stress • Implement interventions, where possible

• Evaluate the interventions • Give your team a measure of freedom; it is OK to tweak the rules and change the goals.

Dr Holt cautioned not to let your ego get involved: “Take 2 steps back and realize that this is not necessarily about you. It’s about the team and the organization—both are a whole lot bigger than you.” She urged attendees to use appropriate body

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April 2014

language and to avoid lecturing.

“Reconvene when you think the team has heard enough or has had enough. Your ultimate goal is to create a safe working environment. In the midst of a crisis, it is important to stay calm. Use humor to diffuse a tense situation. And don’t take yourself too seriously—remember, anything you do to elevate our profession, elevates us all.” l

Claims Processing

Denials Management Isn’t Just Your Billing Department’s Concern

By Matt Terry, MBA, BSRT (R)(T), Director of Oncology Business Operations; and Candy Luna, Corporate Office Manager, Revenue Cycle Inc

A

ccording to the Medical Group Management A­ s­ sociation, only 35% of providers appeal denied claims. Often, we think of denials as issues of medical necessity, but denials often occur for a variety of reasons: incorrect information, correct information but in the wrong format, missed filing deadlines, or information sent to the wrong payer altogether.

Billing offices that do not pay close attention to the details of the claims processing system may spend a lot of money correcting claim errors. Correcting simple mistakes like these and refiling a claim costs approximately $15 per claim. Over time, these expenses add up and distract staff members from performing their intended roles. And offices risk losing considerable revenue if they assume that denialsbased nonpayment means they will never get paid.

Where and when do these claim errors originate? Determining their source is the first line of defense against denials.

Claim submission errors often originate from the time the patient is first registered in the practice database. Collecting all of the patient’s information and verifying that it is accurately put into the system seems like a simple task, but it can be complex and cumbersome.

Taking time to ensure staff members understand and follow processes and policies pays off.

Claim denials can also originate with the clinical staff, including physicians. Incorrect diagnosis and procedural coding can lead to errors that billing staff members have to appeal based on their clinical

knowledge. This means they must be educated on the procedure, the documentation that supports the procedure, and whether the documentation will support the service.

In some cases, the billing staff must

payer required a more specific diagnosis code. Some payers will deny all claims with a diagnosis ending in “.9,” meaning unspecified. In addition, if the diagnosis code is not consistent with the current treatment course but instead applies to a past problem or issue, the claim may be denied.

• Correct coding edits. Edits are important to understand. Not applying a modifier to a service that edits another service will lead to a denial. If staff members do not understand code edits, they might mistakenly attach modifiers to every code. This is termed “hard coding.” While it may solve a problem temporarily, it may also catch the attention of claim reviewers. Con­ tinuing to process claims with services that will not be paid due to edits creates additional, costly work on the back end.

• Duplicate billing. This common error may be a result of staff not paying attention to detail or not understanding how to submit claims to secondary payers. When a duplicate claim is submitted, it potentially increases overall accounts receivable and incurs increased costs to bill correctly.

• Timely filing. Staff members must be aware of timely filing deadlines for all payers, specifically the top payers. Missing deadlines will result in a loss of payment and the inability to recoup money owed.

• Changes to payers’ organiz­ ations. A payer may make changes to its system (eg, requiring preauthorization for payment)

Correcting simple mistakes and refiling a claim costs approximately $15 per claim. Over time, these expenses add up and distract staff members from performing their intended roles.

reach out to clinical staff for this information; once everyone’s salaries are factored in, this potentially increases the cost of an appeal.

Here are a few common reasons for a claim denial: • Patient registration errors.

These include outdated demographic or insurance information.

A periodic review of pa­ tient information can reduce the risk.

• Lack of referral/authorization.

More insurance payers are requiring preauthorization than in the past. Not understanding the requirements of each payer or neglecting to screen every patient for these requirements can lead to costly denials.

• Incorrect diagnosis codes.

Claims may be denied because a

April 2014

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Affordable Care Act Update

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

By Rosemary Frei, MSc

A

s the clocked ticked down to midnight on March 31, many Americans rushed to enroll in health in­surance plans made available to them through the Afford­ able Care Act (ACA).

Ap­proxi­mately 4.2 Ardis D. Hoven, MD million people had selected a Marketplace plan as of March 1, 2014, less than half of the 8.8 million who have been deemed eligible,1 and 60% of the 7 million people the Congress­ ional Budget Office projected for this timeframe.2 But in the 30 days from March 1 until the end of open enrollment, nearly 3 million people signed up for government-run health insurance plans, bringing the total number enrolled to 7.1 million, according to an announcement from President Barack Obama outside the White House on April 1.3

A Law That Is “Helping Millions” Citing other statistics, the President also noted that 3 million young adults have gained health insurance by staying on their parents’ plans, and millions more have been insured through the expansion of Medicaid and children’s health insurance programs. The ACA allows children younger than 26 years of age to remain on their parents’ insurance plans.

“This law is helping millions of Americans,” the President said at the April 1 press conference, “and in the coming years it will help millions more.” He acknowledged that while the ACA has allowed mil-

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lions of Americans to purchase insurance, it does not mean that “all the problems of healthcare have been solved forever,” citing rising private insurance premiums and the millions of Americans who still remain uninsured.3 In addition to those concerns expressed by the President, mainstream media has also explored concerns regarding the ACA, including the impact narrow networks could have on patients with cancer or survivors whose care may not be covered under their purchased plan. For physicians and practice administrators, confusion regarding their inclusion in (or exclusion from) insurance plans’ network panels, questions about reimbursement, and uncertainty regarding the law’s 90-day grace period are lingering.

From the AMA Ardis D. Hoven, MD, president of the American Medical Association (AMA), noted the organization’s efforts and was optimistic in a recent interview that the ACA would help ensure that every American has access to affordable, quality healthcare. Her organization has been working for years with the federal government to make improvements to the ACA and ease the transition, she said.

“As the ACA was implemented, AMA provided fact sheets and toolkits to inform both patients and physicians about aspects of the new law,” Dr Hoven stated. “We will also monitor physician and patient experiences closely so we can accurately identify problems and advocate for solutions.”

She noted in an AMA View­ points article in February that “in

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April 2014

these first months of Affordable Care Act implementation, there’s a lot of uncertainty around health plans sold through the insurance exchanges and how their lack of transparency will impact continuity of patient care.”4 “To help physicians through the transition in their practices, we are providing practical resources, including a six-step checklist we just released with the Medical Group Management Association and forthcoming resources related to managing care through a patient’s 90-day grace period,” she said.4,5 The checklist points are: • Double check whether your practice’s physicians are participating with ACA exchange products; • Determine your practice’s ability to accept new patients; • Train office staff who speak with callers and patients so they can readily answer questions on insurance and enrollment; • As with other insurance, check patient eligibility, coinsurance, de­ductibles, and copays for each visit; • Be prepared to discuss out-ofpocket expenses and the cost of care with each patient; and, • Know the essential health benefits in your state.

In addition, Dr Hoven noted that the AMA is working with state governments on a transparency campaign6 that includes model bills7 on tiered and narrow networks (to provide meaningful access to accurate physician directories, institute due process and physician-profiling protections, and honor patients’ benefits assignments), informing physicians if one of their patients is in a 90-day grace period for nonpayment of pre-

Affordable Care Act Update

miums, and preventing insurers from forcing doctors to participate in all of the insurers’ networks if they agree to be a part of one of their plans.

The AMA has a list of documents written by its officials between 2010 and April 2013 on the ACA implementation regulations.8 The most comprehensive statement was posted in October 2011, noting, “The new law includes many major provisions that are consistent with AMA policy and hold the potential for a stronger, better-performing healthcare system.

While the new law represents a tremendous step forward on the path toward meaningful health system reform, it is not the last step, but rather the beginning.”9 The AMA generally supports many major provisions in the ACA, including increased access to health insurance and the undertaking of comparative effectiveness research.

It also advocates for changes to the ACA, such as postponing penalties related to quality-reporting data and eliminating a Medicare/Medicaid enrollment fee for physicians.9 The organization is also working to modify or alter some measures.

These include delaying implementation of the value-based payment modifier, modification of requirements for referring physicians to tell patients when they are referring the patients to a hospital that they own or are an investor in, and ensuring strategic advancement of electronic health information exchange and interoperability (ie, working toward a smooth exchange of healthcare information between healthcare providers and health insurance providers).10 The AMA’s Board of Trustees voted unanimously to adopt policies crafted at the 2013 annual meeting of the organization’s House of Delegates, which sought to improve the ACA and healthcare. These include: • A call to repeal the nonphysician–provider nondiscrimination

provisions of the ACA; • Opposition to pay-for-performance or value-based purchasing that threatens cuts for participating physicians, and calling instead for positive incentives based on timely and accurate data that incorporate evidence-based measures and appropriate risk adjustment; and • A call to replace the Independent Payment Advisory Board with a

the grace period for nonpayment of premiums. In addition to the AMA, 85 organizations signed the letter.11 “We encourage physicians to keep the AMA and federal government informed as implementation of the law continues,” said Dr Hoven.

Physicians can send an e-mail to exchangeplans@ama-assn.org if they identify any systemic issues that have not yet been addressed. l

References

1. Kaiser Family Foundation. State marketplace statistics. http://kff.org/health-reform/state-indicator/ state-marketplace-statistics-2/. Accessed April 9, 2014.

2. Centers for Medicare & Medicaid Services; US Department of Health and Human Services. Projected monthly enrollment targets for health insurance marketplaces in 2014—information. Memo. September 5, 2013. http://waysandmeans.house.gov/uploadedfiles/ enrolltargets_09052013_.pdf. Accessed April 9, 2014.

3. Shear MD, Pear R. Obama claims victory in push for insurance. April 1, 2014. www.nytimes.com/2014/04/02/ us/politics/obama-to-report-on-progress-of-health-carelaw.html?_r=0. Accessed April 9, 2014.

4. Hoven AD. ACA roll-out may have its bumps, but we’re working toward a stronger future. AMA Viewpoints. February 4, 2014. www.ama-assn.org/ ama/pub/ama-wire/ama-wire.page?plckControl ler=Blog&plckBlogPage=BlogViewPost&UID=e38c f47a-fc5f-473b-9234-c9e714c1c8f0&plckPos tId=Blog%3ae38cf47a-fc5f-473b-9234-c9e714c 1c8f0Post%3ae46896e6-c192-4b83-a348-e91932a beaf0&plckScript=blogScript&plckElementId=blog Dest#.Uwy4UrmPJD9. Accessed April 9, 2014.

5. American Medical Association, Medical Group Management Association. Medical practice checklist for 2014 ACA exchange implementation. www. ama-assn.org/resources/doc/washington/aca_checklist.pdf. Accessed April 10, 2014.

6. American Medical Association Advocacy Resource Center. Health insurance exchanges state implementation transparency campaign. www.ama-assn. org/resources/doc/arc/hix-transparency-summary.pdf.

Accessed April 10, 2014.

7. State implementation of the Affordable Care Act. www.ama-assn.org/ama/pub/advocacy/state-advocacy-arc/ state-advocacy-campaigns/state-health-reform/state-im plementation-aca.page. Accessed April 10, 2014.

8. AMA comments on ACA implementation regulations. www.ama-assn.org/ama/pub/advocacy/topics/ affordable-care-act/ama-comments-on-aca-regula tions.page. Accessed April 10, 2014.

9. Advocating for improvements to the Affordable Care Act. www.ama-assn.org/ama1/pub/uploadmm/399/ aca-advocating-for-improvements.pdf. Accessed April 10, 2014.

10. American Medical Association. Re: advancing interoperability and health information exchange [CMS–0038–NC]. Health information exchanges comment letter. April 22, 2013. www.ama-assn. org/resources/doc/washington/health-information-ex changes-comment-letter-22april2013.pdf. Accessed April 10, 2014.

11. American Medical Association; Medical Group Management Association; American Academy of Child and Adolescent Psychiatry, et al. Re: concerns regarding 90-day grace period in ACA-subsidized exchange health insurance. Letter. March 5, 2014. www.ama-assn.org/resources/doc/washington/acagrace-period-sign-on-05march2014.pdf. Accessed April 10, 2014.

“The new law includes many major provisions that are consistent with AMA policy and hold the potential for a stronger, betterperforming healthcare system. While the new law represents a tremendous step forward on the path toward meaningful health system reform, it is not the last step, but rather the beginning.”

—American Medical Association payment mechanism that is congruent with AMA’s principles and guidelines.

In addition, in early March, the AMA issued a letter to the Centers for Medicare & Medicaid Services (CMS) asking that the organization revisit the policy that allows insurers to deny or pend claims for the second and third months of the 90-day grace period. The AMA also asked that CMS require insurers to notify physicians as soon as a patient has entered

April 2014

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Claims Processing

Denials Management Isn’t Just…Continued from page 13 without alerting participating practices. Staff members must stay informed: subscribe to and read all payer notifications and correspondence to ensure your office takes proper action to amend current processes and ensure preauthorization is obtained.

When billing offices receive numerous denials, staff may be overwhelmed by the appeals procedure.

Without organized tracking processes in place and the ability to educate staff members who provided incorrect information in the first place, significant progress will not be made.

A sizeable number of denials can mean an increase in accounts receiv-

able and potentially lead to blanket appeals; that is, appealing all incoming denials without first understanding the root cause of the denial.

Without understanding the root cause of a claim’s denial, it could likely be denied again, creating even more work. And loose write-off policies are not the answer, either; writing off revenue owed to the practice because of simple clerical errors can be very frustrating.

How can a practice determine where errors are coming from? Most billing software is able to append denial reason codes to each nonpayment received. When nonpayment is posted to a patient’s account, a deni-

al reason code should also be added so formal reports can indicate where the issues are occurring. Denial codes should be set up by the system administrator and the reports tracked by billing office management.

Denials management is the process of tracking claims denials and their reasons, working the appeals, and educating the staff who submit incorrect information. Claims denials can adversely affect an office’s financial health, but if addressed properly, can be mitigated. What’s important to remember is that all staff members—not just those in charge of billing claims—must be involved in denials management. l

Your Expert Oncology Resource

Revenue Cycle Inc. delivers customized, leading-edge strategies and services.

Regardless of your practice setting, our team is able to offer an array of services customized to meet your needs.

Medical & Radiation Oncology Services • Billing, Coding & Compliance • Training & Education • Electronic Medical Record Implementation • Process Review & Development • Client Resource Center

• Remote Solutions • Front Office & Back Office Process Review • Revenue Enhancement • Regulatory Summation Updates • Proforma Creation

To speak to one of our experts, call 512.583.2000 or visit our website at www.revenuecycleinc.com.

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April 2014

Drug Update

Xiaflex (Collagenase Clostridium Histolyticum), First Drug Approved by the FDA for Peyronie’s Disease

By Loretta Fala, Medical Writer

P

eyronie’s disease, also known as curvature of the penis or chronic inflammation of the tunica albuginea, is the development of fibrous scar tissue inside the penis that causes curved, painful erections.1 This condition may prevent a man from having sex or may cause erectile dysfunction.2 The curvature associated with Peyronie’s disease may worsen over time.2 Although the exact cause of Peyronie’s disease is not completely understood, it is thought to result from the rupturing of small blood vessels inside the penis, which may have been damaged during sex, during athletic activity, or as the result of an accident.2 The estimated prevalence of Peyronie’s disease ranges from 1% to 23%.3 Although Peyronie’s disease can occur in men of all ages, its prevalence increases with age.2 Heredity may also play a role. Men who have a connective tissue disorder, including Dupuytren’s contracture, a cord-like thickening that causes the fingers to pull inward, may have an increased risk for Peyronie’s disease.2 A number of other factors that may be linked to Peyronie’s disease include hypertension, diabetes, obesity, hyperlipidemia, smoking, and pelvic surgery.4 In addition to interfering with sexual intercourse, Peyronie’s disease may cause anxiety or stress, place strain on the relationship with a sexual partner, or even make fathering a child challenging because intercourse is difficult or impossible.2 The pain, disfigurement, and erectile dysfunction associated with Peyronie’s disease can impose substantial duress on affected men, including a loss of psychosexual well-being.4 For patients whose symptoms are mild, a watchful waiting approach is sometimes

recommended.1 For patients whose symptoms are more serious, medication or surgery may be recommended by a physician.1 Surgical procedures, including penile implant, are generally not recommended until the curvature of the penis stops increasing and the patient’s erections have been pain-free for at least 6 months.2

The signs and symptoms of Peyronie’s disease are caused by a collagen plaque. The injection of collagen clostridium histolyticum into a Peyronie’s plaque, which is comprised mostly of collagen, may result in the enzymatic disruption of the plaque. After this disruption of the plaque, penile curvature deformity and the patient bother caused

by Peyronie’s disease are reduced.6

First Drug Approved for Peyronie’s Disease In December 2013, collagenase clostridium histolyticum for injection (Xiaflex; Auxilium Pharmaceuticals) became the first pharmacologic treatment to receive US Food and Drug Administration (FDA) approval for the treatment of Peyronie’s disease in men with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. Xiaflex, a biologic agent, is made from the protein product of collagenase clostridium histolyticum, a living organism.5 According to Audrey Gassman, MD, Deputy Director, Division of Bone, Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research, the approval of Xiaflex “expands the available treatment options for men experiencing Peyronie’s disease, and enables them, in consultation with their doctor, to choose the most appropriate treatment option.”5 Collagenase clostridium histolyticum was approved by the FDA in 2010 for the treatment of adult patients with Dupuytren’s contracture with a palpable cord.

Dosing and Administration Collagenase clostridium histolyticum should be administered by a healthcare provider who is experienced in the treatment of male urologic diseases. Collagenase clostridium histolyticum lyophilized powder should be reconstituted with only the supplied diluent before use.

A treatment cycle consists of 2 collagenase clostridium histolyticum injection procedures and a penile modeling procedure. A penile injection must be induced; a single intracavernosal injection of 10 mcg or 20 mcg of alprostadil may be used for this purpose.6 With the penis in the erect state, the target area in the Peyronie’s plaque to be injected must be identified and marked. The penis should be in a flaccid state before collagenase clostridium histolyticum is injected. On each of 2 days, 1 to 3 days apart, 0.58 mg of collagenase clostridium histolyticum is injected into the target plaque, according to the injection procedure.

A penile modeling procedure is performed 1 to 3 days after the second injection of each treatment cycle. For each plaque causing the curvature deformity, up to 4 treatment cycles may be administered. Each treatment cycle may be repeated at approximately 6-week intervals. If the curva-

Mechanism of Action Collagenases are proteinases that hydrolyze collagen in its native triple helical conformation under physiologic conditions, resulting in the lysis of collagen deposits.6

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Drug Update

Xiaflex (Collagenase Clostridium)…Continued from page 17 ollagenase Clostridium Histolyticum: Median Percent Change in Table 1 C Penile Curvature Deformity from Baseline to Week 52 Study 1 Study 2 Collagenase Collagenase clostridium clostridium Penile histolyticum Placebo histolyticum Placebo curvature (N = 199) (N = 104) (N = 202) (N = 107) Baseline 48.8 49 51.3 49.6 mean, degrees Mean –35 –17.8 –33.2 –21.8 change,a % Treatment –17.2b –11.4b difference, % (–26.7 to –7.6) (–19.5 to –3.3) (95% CI) CI indicates confidence interval Mean percent change, treatment difference, 95% CI, and P value were based on an analysis of variance model with factors for treatment, stratum of baseline penile curvature, and their interaction using last observation carried forward in the modified intent-to-treat population. b P <.01.

Source: Xiaflex (collagenase clostridium histolyticum) for injection prescribing information; 2013. a

ture deformity is less than 15 degrees after the first, second, or third treatment cycle, or if further treatment is not clinically indicated, then subsequent treatment cycles should not be administered.6 This treatment is available as a single-use glass vial containing 0.9 mg of collagenase clostridium histolyticum as a sterile, lyophilized powder for reconstitution.

It is also available as a sterile diluent in a single-use glass vial.6

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Clinical Studies The efficacy of collagenase clostridium histolyticum was evaluated in 2 randomized, double-blind, placebo-controlled trials of 832 adult men with Peyronie’s disease (Study 1 and Study 2). To be included in the study, patients had to have penile curvature deformity of at least 30 degrees in the stable phase of Peyronie’s disease. Patients were excluded if they had a ventral curvature deformity, an isolated hourglass deformity, or a calcified plaque that could have interfered with the injection technique. At baseline, penile pain was either not present or was mild in most (98%) patients.6

Patients received up to 4 treatment cycles of collagenase clostridium histolyticum or of placebo (weeks 0, 6, 12, 18) and were followed in a nontreatment follow-up period (weeks 24-52). In each treatment cycle, 2 injections of collagenase clostridium histolyticum or 2 injections of placebo were administered 1 to 3 days apart. A penile modeling procedure was performed on patients at the study site 1 to 3 days after the second injection of the cycle.

The treatment cycle was repeated at approximately 6-week intervals for up to 3 additional times, for a maximum of 8 total injection procedures and 4 total modeling procedures.

Patients were also instructed to perform penile modeling at home for 6 weeks after each treatment cycle.6 The coprimary end points in Study 1 and Study 2 were the percent change from baseline to week 52 in penile curvature deformity and the change in the bother domain score of the Peyronie’s Disease Questionnaire from baseline to week 52. The bother domain score is a composite of patient-reported items, including concern about erection pain, erec-

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tion appearance, and the impact of Peyronie’s disease on intercourse and on the frequency of intercourse.6 Patients with Peyronie’s disease receiving collagenase clostridium histolyticum had significantly improved penile curvature deformity compared with patients receiving placebo (Table 1). The improvement was numerically similar among patients with baseline curvature deformity from 30 degrees to 60 degrees and those with curvature deformity from 61 degrees to 90 degrees.6 Patients receiving collagenase clostridium histolyticum also had a significant reduction in patient-reported bother associated with Peyronie’s disease compared with patients receiving placebo (Table 2). The reduction in the bother domain score was numerically similar between patient groups stratified by degree of baseline curvature deformity (30-60 degrees and 61-90 degrees).6

Safety The safety data for collagenase clostridium histolyticum were obtained from controlled and uncontrolled clinical studies in 1044 patients with Peyronie’s disease who received a total of 7466 injections of collagenase clostridium histolyticum.6 The most common (≥25%) ad­verse reactions reported in patients treated with collagenase clostridium histolyticum and at an incidence greater than in patients receiving placebo were penile hematoma, penile swelling, and penile pain.6 Warnings and Precautions Boxed warning. The prescribing information for collagenase clostridium histolyticum contains a boxed warning stating that corporal rupture (penile fracture) was reported as an adverse reaction in 5 of 1044 (0.5%) patients treated with this drug in clinical studies. In 9 (0.9%) of the patients, a diagnosis of corporal rupture cannot

Drug Update

be excluded. Severe penile hematoma was also reported as an adverse reaction in 39 (3.7%) patients treated with collagenase clostridium histolyticum. The boxed warning also states that collagenase clostridium histolyticum is available for the treatment of Peyronie’s disease only through a restricted Risk Evaluation and Mitigation Strategy program.6 Contraindications. Collagenase clostridium histolyticum is contraindicated in patients with Peyronie’s plaque that involve the penile urethra and in patients with a history of severe allergic reaction to this drug or to collagenase used in other applications.6 Tendon rupture or serious injury. Collagenase clostridium histolyticum should not be injected into tendons, nerves, blood vessels, or other collagen-containing structures of the hand. Injection into these structures may result in possible permanent injury, such as tendon rupture or ligament damage.6 Serious injury to the penis.

Collagenase clostridium histolyticum should not be injected into the urethra, nerves, blood vessels, corpora cavernosa, or other collagen-containing structures of the penis. Injection into these structures may result in possible permanent injury, such as corporal rupture (penile fracture).6 Allergic reactions. Healthcare providers should be prepared to address severe allergic reactions after collagenase clostridium histolyticum injections.6 Patients with abnormal coagulation. Collagenase clostridium histolyticum should be used with caution in patients with abnormal coagulation, including patients who have received anticoagulant medications, other than low-dose aspirin, within 7 days of the injection.6 Drug interactions. Collagenase clostridium histolyticum should be used with caution in patients receiving anticoagulant therapies, except for low-dose aspirin.

Table 2 Collagenase Clostridium Histolyticum: Mean Change in Peyronie’s Disease Bother Domain Score from Baseline to Week 52 Study 1 Study 2 Collagenase Collagenase Bother clostridium clostridium domain histolyticum Placebo histolyticum Placebo score (N = 199) (N = 104) (N = 202) (N = 107) Baseline 7.5 7.4 7.4 8.2 mean, degrees Mean –2.8 –1.6 –2.6 –1.5 change,a % Treatment –1.2b –1.1b difference, % (–2.4 to –0.03) (–2.1 to –0.002) (95% CI) CI indicates confidence interval Mean change, treatment difference, 95% CI, and P value were based on an analysis of variance model with factors for treatment, stratum of baseline penile curvature, and their interaction using last observation carried forward in the modified intent-to-treat population. b P <.05.

Source: Xiaflex (collagenase clostridium histolyticum) for injection prescribing information; 2013. a

Use in Specific Populations Pregnancy. There are no adequate and well-controlled studies of collagenase clostridium histolyticum in pregnant women. Collagenase clostridium histolyticum should only be used during pregnancy if clearly needed.6 Nursing mothers. It is not known whether collagenase clostridium histolyticum is excreted in human milk.

Because many drugs are excreted in human milk, caution should be exercised when collagenase clostridium histolyticum is administered to a nursing woman.6 Pediatric use. The safety and effectiveness of collagenase clostridium histolyticum in pediatric patients aged <18 years have not been established.6 Geriatric use. Of the 551 patients receiving collagenase clostridium histolyticum in the clinical trials of Peyronie’s disease, 100 (18%) were aged ≥65 years and 5 (0.9%) were aged ≥75 years. No overall differences in safety were observed in these patients.6

Peyronie’s disease, which is the only alternative to surgery. This approval offers patients with Peyronie’s disease who are not candidates for a surgical procedure a new, and the only, noninvasive approach to therapy. Treatment with collagenase clostridium histolyticum showed a significant improvement in penile curvature deformity in patients with Peyronie’s disease and a significant reduction in patient-reported bother associated with Peyronie’s disease.

The most frequent adverse reactions reported in ≥25% of patients treated with collagenase clostridium histolyticum and at an incidence greater than in patients receiving placebo were penile hematoma, penile swelling, and penile pain. l

References

1. Nordqvist C. What is Peyronie’s disease? What causes Peyronie’s disease? Medical News Today. March 8, 2012. www.medicalnewstoday. com/articles/242682.php. Accessed January 2, 2014.

2. Mayo Clinic staff. Diseases and conditions: Peyronie’s disease.

August 18, 2011. www.mayoclinic.com/health/peyronies-disease/DS0 0427/METHOD=print. Accessed December 30, 2013.

3. National Kidney and Urologic Diseases Information Clearinghouse.

Peyronie’s disease. Updated March 23, 2012. http://kidney.niddk.nih. gov/KUDiseases/pubs/peyronie/index.aspx#1. Accessed January 3, 2014.

4. Levine LA. The clinical and psychosocial impact of Peyronie’s disease. Am J Manag Care. 2013;19(4 suppl):S55-S61.

5. US Food and Drug Administration. FDA approves first drug treatment for Peyronie’s disease. Press release. December 6, 2013. www. fda.gov/newsevents/newsroom/pressannouncements/ucm377849.htm.

Accessed January 2, 2014.

6. Xiaflex (collagenase clostridium histolyticum) for injection [prescribing information]. Chesterbrook, PA: Auxilium Pharmaceuticals, Inc; December 2013.

Conclusion The recent FDA approval of a new indication for collagenase clostridium histolyticum marks the availability of the first pharmacologic treatment option for men with

April 2014

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ZYTIGA® (abiraterone acetate) Tablets Brief Summary of Prescribing Information.

INDICATIONS AND USAGE ZYTIGA is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer.

CONTRAINDICATIONS Pregnancy: ZYTIGA can cause fetal harm when administered to a pregnant woman. ZYTIGA is not indicated for use in women. ZYTIGA is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for pregnancy loss [see Use in Specific Populations].

WARNINGS AND PRECAUTIONS Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess: ZYTIGA may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition [see Clinical Pharmacology (12.1) in full Prescribing Information].

In the two randomized clinical trials, grade 3 to 4 hypertension occurred in 2% of patients, grade 3 to 4 hypokalemia in 4% of patients, and grade 3 to 4 edema in 1% of patients treated with ZYTIGA [see Adverse Reactions].

Co-administration of a corticosteroid suppresses adrenocorticotropic hormone (ACTH) drive, resulting in a reduction in the incidence and severity of these adverse reactions. Use caution when treating patients whose underlying medical conditions might be compromised by increases in blood pressure, hypokalemia or fluid retention, e.g., those with heart failure, recent myocardial infarction or ventricular arrhythmia. Use ZYTIGA with caution in patients with a history of cardiovascular disease. The safety of ZYTIGA in patients with left ventricular ejection fraction <50% or New York Heart Association (NYHA) Class III or IV heart failure (in Study 1) or NYHA Class II to IV heart failure (in Study 2) was not established because these patients were excluded from these randomized clinical trials [see Clinical Studies (14) in full Prescribing Information]. Monitor patients for hypertension, hypokalemia, and fluid retention at least once a month. Control hypertension and correct hypokalemia before and during treatment with ZYTIGA. Adrenocortical Insufficiency: Adrenal insufficiency occurred in the two randomized clinical studies in 0.5% of patients taking ZYTIGA and in 0.2% of patients taking placebo. Adrenocortical insufficiency was reported in patients receiving ZYTIGA in combination with prednisone, following interruption of daily steroids and/or with concurrent infection or stress. Use caution and monitor for symptoms and signs of adrenocortical insufficiency, particularly if patients are withdrawn from prednisone, have prednisone dose reductions, or experience unusual stress. Symptoms and signs of adrenocortical insufficiency may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with ZYTIGA. If clinically indicated, perform appropriate tests to confirm the diagnosis of adrenocortical insufficiency. Increased dosage of corticosteroids may be indicated before, during and after stressful situations [see Warnings and Precautions].

Hepatotoxicity: In the two randomized clinical trials, grade 3 or 4 ALT or AST increases (at least 5X ULN) were reported in 4% of patients who received ZYTIGA, typically during the first 3 months after starting treatment. Patients whose baseline ALT or AST were elevated were more likely to experience liver test elevation than those beginning with normal values. Treatment discontinuation due to liver enzyme increases occurred in 1% of patients taking ZYTIGA. No deaths clearly related to ZYTIGA were reported due to hepatotoxicity events.

Measure serum transaminases (ALT and AST) and bilirubin levels prior to starting treatment with ZYTIGA, every two weeks for the first three months of treatment and monthly thereafter. In patients with baseline moderate hepatic impairment receiving a reduced ZYTIGA dose of 250 mg, measure ALT, AST, and bilirubin prior to the start of treatment, every week for the first month, every two weeks for the following two months of treatment and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop.

Elevations of AST, ALT, or bilirubin from the patient’s baseline should prompt more frequent monitoring. If at any time AST or ALT rise above five times the ULN, or the bilirubin rises above three times the ULN, interrupt ZYTIGA treatment and closely monitor liver function.

Re-treatment with ZYTIGA at a reduced dose level may take place only after return of liver function tests to the patient’s baseline or to AST and ALT less than or equal to 2.5X ULN and total bilirubin less than or equal to 1.5X ULN [see Dosage and Administration (2.2) in full Prescribing Information].

The safety of ZYTIGA re-treatment of patients who develop AST or ALT greater than or equal to 20X ULN and/or bilirubin greater than or equal to 10X ULN is unknown.

Increased ZYTIGA Exposures with Food: ZYTIGA must be taken on an empty stomach. No food should be consumed for at least two hours before the dose of ZYTIGA is taken and for at least one hour after the dose of ZYTIGA is taken. Abiraterone Cmax and AUC0-∞ (exposure) were increased up to 17and 10-fold higher, respectively, when a single dose of abiraterone acetate was administered with a meal compared to a fasted state. The safety of these increased exposures when multiple doses of abiraterone acetate are taken with food has not been assessed [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) in full Prescribing Information].

ZYTIGA® (abiraterone acetate) Tablets ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: • Hypertension, Hypokalemia, and Fluid Retention due to Mineralocorticoid Excess [see Warnings and Precautions].

• Adrenocortical Insufficiency [see Warnings and Precautions].

• Hepatotoxicity [see Warnings and Precautions].

• Increased ZYTIGA Exposures with Food [see Warnings and Precautions].

Clinical Trial Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Two randomized placebo-controlled, multicenter clinical trials enrolled patients who had metastatic castration-resistant prostate cancer who were using a gonadotropin-releasing hormone (GnRH) agonist or were previously treated with orchiectomy. In both Study 1 and Study 2 ZYTIGA was administered at a dose of 1,000 mg daily in combination with prednisone 5 mg twice daily in the active treatment arms. Placebo plus prednisone 5 mg twice daily was given to control patients.

The most common adverse drug reactions (≥10%) reported in the two randomized clinical trials that occurred more commonly (>2%) in the abiraterone acetate arm were fatigue, joint swelling or discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection and contusion.

The most common laboratory abnormalities (>20%) reported in the two randomized clinical trials that occurred more commonly (≥2%) in the abiraterone acetate arm were anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, elevated AST, hypophosphatemia, elevated ALT and hypokalemia.

Study 1: Metastatic CRPC Following Chemotherapy: Study 1 enrolled 1195 patients with metastatic CRPC who had received prior docetaxel chemotherapy. Patients were not eligible if AST and/or ALT ≥2.5X ULN in the absence of liver metastases. Patients with liver metastases were excluded if AST and/or ALT >5X ULN. Table 1 shows adverse reactions on the ZYTIGA arm in Study 1 that occurred with a ≥2% absolute increase in frequency compared to placebo or were events of special interest. The median duration of treatment with ZYTIGA was 8 months.

Table 1: Adverse Reactions due to ZYTIGA in Study 1 ZYTIGA with Placebo with Prednisone (N=791) Prednisone (N=394) 1 System/Organ Class All Grades Grade 3-4 All Grades Grade 3-4 Adverse reaction % % % % Musculoskeletal and connective tissue disorders Joint swelling/ 29.5 discomfort2 4.2 23.4 4.1 Muscle discomfort3 26.2 3.0 23.1 2.3 General disorders Edema4 26.7 1.9 18.3 0.8 Vascular disorders Hot flush 19.0 0.3 16.8 0.3 Hypertension 8.5 1.3 6.9 0.3 Gastrointestinal disorders Diarrhea 17.6 0.6 13.5 1.3 Dyspepsia 6.1 0 3.3 0 Infections and infestations Urinary tract infection 11.5 2.1 7.1 0.5 Upper respiratory tract infection 5.4 0 2.5 0 Respiratory, thoracic and mediastinal disorders Cough 10.6 0 7.6 0 Renal and urinary disorders Urinary frequency 7.2 0.3 5.1 0.3 Nocturia 6.2 0 4.1 0 Injury, poisoning and procedural complications Fractures5 5.9 1.4 2.3 0 Cardiac disorders Arrhythmia6 7.2 1.1 4.6 1.0 Chest pain or chest 7 discomfort 3.8 0.5 2.8 0 Cardiac failure8 2.3 1.9 1.0 0.3

ZYTIGA® (abiraterone acetate) Tablets

ZYTIGA® (abiraterone acetate) Tablets

1 Adverse events graded according to CTCAE version 3.0 2 Includes terms Arthritis, Arthralgia, Joint swelling, and Joint stiffness 3 Includes terms Muscle spasms, Musculoskeletal pain, Myalgia,

Table 3: Adverse Reactions in ≥5% of Patients on the ZYTIGA Arm in Study 2 (continued) ZYTIGA with Placebo with Prednisone (N=542) Prednisone (N=540) System/Organ Class All Grades1 Grade 3-4 All Grades Grade 3-4 Adverse reaction % % % % Renal and urinary disorders Hematuria 10.3 1.3 5.6 0.6 Skin and subcutaneous tissue disorders Rash 8.1 0.0 3.7 0.0 1 Adverse events graded according to CTCAE version 3.0 2 Includes terms Edema peripheral, Pitting edema, and Generalized edema 3 Includes terms Arthritis, Arthralgia, Joint swelling, and Joint stiffness Table 4 shows laboratory abnormalities that occurred in greater than 15% of patients, and more frequently (>5%) in the ZYTIGA arm compared to placebo in Study 2. Grade 3-4 lymphopenia (9%), hyperglycemia (7%) and high alanine aminotransferase (6%) occurred at a greater than 5% rate in the ZYTIGA arm.

Musculoskeletal discomfort, and Musculoskeletal stiffness terms Edema, Edema peripheral, Pitting edema, and Generalized edema 5 Includes all fractures with the exception of pathological fracture 6 Includes terms Arrhythmia, Tachycardia, Atrial fibrillation, Supraventricular tachycardia, Atrial tachycardia, Ventricular tachycardia, Atrial flutter, Bradycardia, Atrioventricular block complete, Conduction disorder, and Bradyarrhythmia 7 Includes terms Angina pectoris, Chest pain, and Angina unstable.

Myocardial infarction or ischemia occurred more commonly in the placebo arm than in the ZYTIGA arm (1.3% vs. 1.1% respectively).

8 Includes terms Cardiac failure, Cardiac failure congestive, Left ventricular dysfunction, Cardiogenic shock, Cardiomegaly, Cardiomyopathy, and Ejection fraction decreased 4 Includes

Table 2 shows laboratory abnormalities of interest from Study 1. Grade 3-4 low serum phosphorus (7%) and low potassium (5%) occurred at a greater than or equal to 5% rate in the ZYTIGA arm.

Table 2: Laboratory Abnormalities of Interest in Study 1 Abiraterone (N=791) Placebo (N=394) Laboratory All Grades Grade 3-4 All Grades Grade 3-4 Abnormality (%) (%) (%) (%) Hypertriglyceridemia 62.5 0.4 53.0 0 High AST 30.6 2.1 36.3 1.5 Hypokalemia 28.3 5.3 19.8 1.0 Hypophosphatemia 23.8 7.2 15.7 5.8 High ALT 11.1 1.4 10.4 0.8 High Total Bilirubin 6.6 0.1 4.6 0 Study 2: Metastatic CRPC Prior to Chemotherapy: Study 2 enrolled 1088 patients with metastatic CRPC who had not received prior cytotoxic chemotherapy. Patients were ineligible if AST and/or ALT ≥2.5X ULN and patients were excluded if they had liver metastases.

Table 3 shows adverse reactions on the ZYTIGA arm in Study 2 that occurred with a ≥2% absolute increase in frequency compared to placebo.

The median duration of treatment with ZYTIGA was 13.8 months.

Table 3: Adverse Reactions in ≥5% of Patients on the ZYTIGA Arm in Study 2 ZYTIGA with Placebo with Prednisone (N=542) Prednisone (N=540) System/Organ Class All Grades1 Grade 3-4 All Grades Grade 3-4 Adverse reaction % % % % General disorders Fatigue 39.1 2.2 34.3 1.7 Edema2 25.1 0.4 20.7 1.1 Pyrexia 8.7 0.6 5.9 0.2 Musculoskeletal and connective tissue disorders Joint swelling/ discomfort3 30.3 2.0 25.2 2.0 Groin pain 6.6 0.4 4.1 0.7 Gastrointestinal disorders Constipation 23.1 0.4 19.1 0.6 Diarrhea 21.6 0.9 17.8 0.9 Dyspepsia 11.1 0.0 5.0 0.2 Vascular disorders Hot flush 22.3 0.2 18.1 0.0 Hypertension 21.6 3.9 13.1 3.0 Respiratory, thoracic and mediastinal disorders Cough 17.3 0.0 13.5 0.2 Dyspnea 11.8 2.4 9.6 0.9 Psychiatric disorders Insomnia 13.5 0.2 11.3 0.0 Injury, poisoning and procedural complications Contusion 13.3 0.0 9.1 0.0 Falls 5.9 0.0 3.3 0.0 Infections and infestations Upper respiratory tract infection 12.7 0.0 8.0 0.0 Nasopharyngitis 10.7 0.0 8.1 0.0

Table 4: Laboratory Abnormalities in >15% of Patients in the ZYTIGA Arm of Study 2 Abiraterone (N = 542) Placebo (N = 540) Laboratory Grade 1-4 Grade 3-4 Grade 1-4 Grade 3-4 Abnormality % % % % Hematology Lymphopenia 38.2 8.7 31.7 7.4 Chemistry Hyperglycemia1 56.6 6.5 50.9 5.2 High ALT 41.9 6.1 29.1 0.7 High AST 37.3 3.1 28.7 1.1 Hypernatremia 32.8 0.4 25.0 0.2 Hypokalemia 17.2 2.8 10.2 1.7 1Based on non-fasting blood draws Cardiovascular Adverse Reactions: In the combined data for studies 1 and 2, cardiac failure occurred more commonly in patients treated with ZYTIGA compared to patients on the placebo arm (2.1% versus 0.7%).

Grade 3-4 cardiac failure occurred in 1.6% of patients taking ZYTIGA and led to 5 treatment discontinuations and 2 deaths. Grade 3-4 cardiac failure occurred in 0.2% of patients taking placebo. There were no treatment discontinuations and one death due to cardiac failure in the placebo group.

In Study 1 and 2, the majority of arrhythmias were grade 1 or 2. There was one death associated with arrhythmia and one patient with sudden death in the ZYTIGA arms and no deaths in the placebo arms. There were 7 (0.5%) deaths due to cardiorespiratory arrest in the ZYTIGA arms and 3 (0.3%) deaths in the placebo arms. Myocardial ischemia or myocardial infarction led to death in 3 patients in the placebo arms and 2 deaths in the ZYTIGA arms.

DRUG INTERACTIONS Drugs that Inhibit or Induce CYP3A4 Enzymes: Based on in vitro data, ZYTIGA is a substrate of CYP3A4.

In a dedicated drug interaction trial, co-administration of rifampin, a strong CYP3A4 inducer, decreased exposure of abiraterone by 55%. Avoid concomitant strong CYP3A4 inducers during ZYTIGA treatment. If a strong CYP3A4 inducer must be co-administered, increase the ZYTIGA dosing frequency [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3) in full Prescribing Information].

In a dedicated drug interaction trial, co-administration of ketoconazole, a strong inhibitor of CYP3A4, had no clinically meaningful effect on the pharmacokinetics of abiraterone [see Clinical Pharmacology (12.3) in full Prescribing Information].

Effects of Abiraterone on Drug Metabolizing Enzymes: ZYTIGA is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6. In a CYP2D6 drug-drug interaction trial, the Cmax and AUC of dextromethorphan (CYP2D6 substrate) were increased 2.8- and 2.9-fold, respectively, when dextromethorphan was given with abiraterone acetate 1,000 mg daily and prednisone 5 mg twice daily. Avoid co-administration of abiraterone acetate with substrates of CYP2D6 with a narrow therapeutic index (e.g., thioridazine).

If alternative treatments cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate drug [see Clinical Pharmacology (12.3) in full Prescribing Information].

ZYTIGA® (abiraterone acetate) Tablets

ZYTIGA® (abiraterone acetate) Tablets

In vitro, ZYTIGA inhibits CYP2C8. There are no clinical data on the use of ZYTIGA with drugs that are substrates of CYP2C8. However, patients should be monitored closely for signs of toxicity related to the CYP2C8 substrate if used concomitantly with abiraterone acetate.

OVERDOSAGE Human experience of overdose with ZYTIGA is limited.

There is no specific antidote. In the event of an overdose, stop ZYTIGA, undertake general supportive measures, including monitoring for arrhythmias and cardiac failure and assess liver function.

Storage and Handling: Store at 20°C to 25°C (68°F to 77°F); excursions permitted in the range from 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature].

Based on its mechanism of action, ZYTIGA may harm a developing fetus.

Therefore, women who are pregnant or women who may be pregnant should not handle ZYTIGA without protection, e.g., gloves [see Use in Specific Populations].

USE IN SPECIFIC POPULATIONS Pregnancy: Pregnancy Category X [see Contraindications].: ZYTIGA can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. While there are no adequate and well-controlled studies with ZYTIGA in pregnant women and ZYTIGA is not indicated for use in women, it is important to know that maternal use of a CYP17 inhibitor could affect development of the fetus. Abiraterone acetate caused developmental toxicity in pregnant rats at exposures that were lower than in patients receiving the recommended dose. ZYTIGA is contraindicated in women who are or may become pregnant while receiving the drug. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for pregnancy loss. Advise females of reproductive potential to avoid becoming pregnant during treatment with ZYTIGA. In an embryo-fetal developmental toxicity study in rats, abiraterone acetate caused developmental toxicity when administered at oral doses of 10, 30 or 100 mg/kg/day throughout the period of organogenesis (gestational days 6-17). Findings included embryo-fetal lethality (increased post implantation loss and resorptions and decreased number of live fetuses), fetal developmental delay (skeletal effects) and urogenital effects (bilateral ureter dilation) at doses ≥10 mg/kg/day, decreased fetal ano-genital distance at ≥30 mg/kg/day, and decreased fetal body weight at 100 mg/kg/day. Doses ≥10 mg/kg/day caused maternal toxicity. The doses tested in rats resulted in systemic exposures (AUC) approximately 0.03, 0.1 and 0.3 times, respectively, the AUC in patients.

Nursing Mothers: ZYTIGA is not indicated for use in women. It is not known if abiraterone acetate is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from ZYTIGA, a decision should be made to either discontinue nursing, or discontinue the drug taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness of ZYTIGA in pediatric patients have not been established.

Geriatric Use: Of the total number of patients receiving ZYTIGA in phase 3 trials, 73% of patients were 65 years and over and 30% were 75 years and over. No overall differences in safety or effectiveness were observed between these elderly patients and younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Patients with Hepatic Impairment: The pharmacokinetics of abiraterone were examined in subjects with baseline mild (n=8) or moderate (n=8) hepatic impairment (Child-Pugh Class A and B, respectively) and in 8 healthy control subjects with normal hepatic function. The systemic exposure (AUC) of abiraterone after a single oral 1,000 mg dose of ZYTIGA increased by approximately 1.1-fold and 3.6-fold in subjects with mild and moderate baseline hepatic impairment, respectively compared to subjects with normal hepatic function.

No dosage adjustment is necessary for patients with baseline mild hepatic impairment. In patients with baseline moderate hepatic impairment (ChildPugh Class B), reduce the recommended dose of ZYTIGA to 250 mg once daily. If elevations in ALT or AST >5X ULN or total bilirubin >3X ULN occur in patients with baseline moderate hepatic impairment, discontinue ZYTIGA treatment [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) in full Prescribing Information].

The safety of ZYTIGA in patients with baseline severe hepatic impairment has not been studied. These patients should not receive ZYTIGA. For patients who develop hepatotoxicity during treatment, interruption of treatment and dosage adjustment may be required [see Dosage and Administration (2.2) in full Prescribing Information, Warnings and Precautions, and Clinical Pharmacology (12.3)] in full Prescribing Information.

Patients with Renal Impairment: In a dedicated renal impairment trial, the mean PK parameters were comparable between healthy subjects with normal renal function (N=8) and those with end stage renal disease (ESRD) on hemodialysis (N=8) after a single oral 1,000 mg dose of ZYTIGA. No dosage adjustment is necessary for patients with renal impairment [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) in full Prescribing Information].

PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information) • Patients should be informed that ZYTIGA and prednisone are used together and that they should not interrupt or stop either of these medications without consulting their physician.

• Patients receiving GnRH agonists should be informed that they need to maintain this treatment during the course of treatment with ZYTIGA and prednisone.

• Patients should be informed that ZYTIGA must not be taken with food and that no food should be consumed for at least two hours before the dose of ZYTIGA is taken and for at least one hour after the dose of ZYTIGA is taken. They should be informed that the tablets should be swallowed whole with water without crushing or chewing. Patients should be informed that taking ZYTIGA with food causes increased exposure and this may result in adverse reactions.

• Patients should be informed that ZYTIGA is taken once daily and prednisone is taken twice daily according to their physician’s instructions.

• Patients should be informed that in the event of a missed daily dose of ZYTIGA or prednisone, they should take their normal dose the following day. If more than one daily dose is skipped, patients should be told to inform their physician.

• Patients should be apprised of the common side effects associated with ZYTIGA, including peripheral edema, hypokalemia, hypertension, elevated liver function tests, and urinary tract infection. Direct the patient to a complete list of adverse drug reactions in PATIENT INFORMATION. • Patients should be advised that their liver function will be monitored using blood tests.

• Patients should be informed that ZYTIGA may harm a developing fetus; thus, women who are pregnant or women who may be pregnant should not handle ZYTIGA without protection, e.g., gloves. Patients should also be informed that it is not known whether abiraterone or its metabolites are present in semen and they should use a condom if having sex with a pregnant woman. The patient should use a condom and another effective method of birth control if he is having sex with a woman of child-bearing potential. These measures are required during and for one week after treatment with ZYTIGA. Manufactured by: Patheon Inc. Mississauga, Canada Manufactured for: Janssen Biotech, Inc. Horsham, PA 19044 © Janssen Biotech, Inc. 2012 Revised: September 2013 003185-130920

INDICATION and IMPORTANT SAFETY INFORMATION about ZYTIGA® (abiraterone acetate) INDICATION ZYTIGA® (abiraterone acetate) in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).

IMPORTANT SAFETY INFORMATION

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Contraindications ZYTIGA® (abiraterone acetate) is not indicated for use in women. ZYTIGA® can cause fetal harm (Pregnancy Category X) when administered to a pregnant woman and is contraindicated in women who are or may become pregnant.

Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess Use with caution in patients with a history of cardiovascular disease or with medical conditions that might be compromised by increases in blood pressure, hypokalemia, or fluid retention. ZYTIGA® may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. Safety has not been established in patients with LVEF <50% or New York Heart Association (NYHA) Class III or IV heart failure (in Study 1) or NYHA Class II to IV heart failure (in Study 2) because these patients were excluded from these randomized clinical trials. Control hypertension and correct hypokalemia before and during treatment. Monitor blood pressure, serum potassium, and symptoms of fluid retention at least monthly.

Adrenocortical Insufficiency (AI) AI was reported in patients receiving ZYTIGA® in combination with prednisone, after an interruption of daily steroids and/or with concurrent infection or stress. Use caution and monitor for symptoms and signs of AI if prednisone is stopped or withdrawn, if prednisone dose is reduced, or if the patient experiences unusual stress. Symptoms and signs of AI may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with ZYTIGA®. Perform appropriate tests, if indicated, to confirm AI. Increased dosages of corticosteroids may be used before, during, and after stressful situations.

Hepatotoxicity Monitor liver function and modify, withhold, or discontinue ZYTIGA® dosing as recommended (see Prescribing Information for more information). Measure serum transaminases [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)] and bilirubin levels prior to starting treatment with ZYTIGA®, every two weeks for the first three months of treatment, and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from the patient’s baseline should prompt more frequent monitoring. If at any time AST or ALT rise above five times the upper limit of normal (ULN) or the bilirubin rises above three times the ULN, interrupt ZYTIGA® treatment and closely monitor liver function.

Increased ZYTIGA® Exposures with Food ZYTIGA® must be taken on an empty stomach. No food should be eaten for at least two hours before the dose of ZYTIGA® is taken and for at least one hour after the dose of ZYTIGA® is taken. Abiraterone Cmax and AUC0-∞ (exposure) were increased up to 17- and 10- fold higher, respectively, when a single dose of abiraterone acetate was administered with a meal compared to a fasted state.

Adverse Reactions The most common adverse reactions (≥10%) are fatigue, joint swelling or discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection and contusion.

The most common laboratory abnormalities (>20%) are anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, elevated AST, hypophosphatemia, elevated ALT and hypokalemia.

Drug Interactions Based on in vitro data, ZYTIGA® is a substrate of CYP3A4. In a drug interaction trial, co-administration of rifampin, a strong CYP3A4 inducer, decreased exposure of abiraterone by 55%. Avoid concomitant strong CYP3A4 inducers during ZYTIGA® treatment. If a strong CYP3A4 inducer must be co-administered, increase the ZYTIGA® dosing frequency only during the co-administration period [see Dosage and Administration (2.3)]. In a dedicated drug interaction trial, co-administration of ketoconazole, a strong inhibitor of CYP3A4, had no clinically meaningful effect on the pharmacokinetics of abiraterone.

ZYTIGA® is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6. Avoid co-administration with CYP2D6 substrates with a narrow therapeutic index. If alternative treatments cannot be used, exercise caution and consider a dose reduction of the CYP2D6 substrate drug. In vitro, ZYTIGA® inhibits CYP2C8. There are no clinical data on the use of ZYTIGA® with drugs that are substrates of CYP2C8. Patients should be monitored closely for signs of toxicity related to the CYP2C8 substrate if used concomitantly with abiraterone acetate.

Use in Specific Populations Do not use ZYTIGA® in patients with baseline severe hepatic impairment (Child-Pugh Class C).

Please see Brief Summary of Prescribing Information on adjacent pages. © Janssen Biotech, Inc. 2013

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Our goal is to make access to ZYTIGA®(abiraterone acetate) simple, convenient, and easy.

Support for you:

Support for your patients:

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Rapid investigation and assessment of patient eligibility and coverage • Prior authorization support • Information on cost support options, including updates on independent foundation funding status • Electronic enrollment through an online portal • Identification of a Specialty Pharmacy Provider (SPP) • Access to medication order information • A personally-assigned Site Coordinator Business Hours

• Explanation of benefits from a personally-assigned Care Coordinator • Referral to cost support options, including the ZytigaOne™ Instant Savings Program for eligible patients • Upon request, follow-up status calls to those referred for cost support • Coordination with SPP for processing and delivery of medication • Educational materials and personalized prescription reminders, if requested

Take advantage of ZytigaOne™ Support today.

1-855-ZYTIGA-1 (998-4421) Monday–Friday, 8:00 AM–8:00 PM ET

ACCESS TO ZYTIGA® SIMPLIFIED FOR YOU AND YOUR PATIENTS More information at ZYTIGAHCP.com

Please see Important Safety Information on back, and Brief Summary of Prescribing Information on adjacent pages.

Patient insurance benefit investigation is provided as a service by The Lash Group, Inc., under contract for Janssen Biotech, Inc. In this regard, The Lash Group, Inc., assists healthcare professionals in the determination of whether treatment could be covered by the applicable third-party payer based on coverage guidelines provided by the payer and patient information provided by the healthcare provider under appropriate authorization following the provider’s exclusive determination of medical necessity.

Importantly, insurance verification is the ultimate responsibility of the provider. Third-party reimbursement is affected by many factors. Therefore, The Lash Group, Inc., and Janssen Biotech make no representation or guarantee that full or partial insurance reimbursement or any other payment will be available. This information is provided as an information service only. While The Lash Group, Inc., tries to provide correct information, it and Janssen Biotech make no representations or warranties, express or implied, as to the accuracy of the information. In no event shall The Lash Group, Inc., or Janssen Biotech or its employees or agents be liable for any damages resulting from or relating to the services. All providers and other users of this information agree that they accept responsibility for the use of this service.

Janssen Biotech assumes no responsibility for, and does not guarantee the quality, scope, or availability of the services including but not limited to reimbursement support services, patient education, and other support services. Each provider, not Janssen Biotech, is responsible for the services they provide. These support services have no independent value to providers apart from the product and are included within the cost of the product. © Janssen Biotech, Inc. 2013

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