UPM February 2014

Urology Practice Management ™

PROCESS IMPROVEMENTS TO ENHANCE PATIENT CARE™

FEBRUARY 2014

www.UroPracticeManagement.com

VOLUME 3 • NUMBER 1

Adding Radiation Controlling Your Practice’s Destiny to Antiandrogen Hormone Therapy By Sandra Paton Extends Survival San Diego, CA—Do you know where Association’s annual your practice is heading? If so, you are conference, where he in Patients with in control of your practice’s destiny. noted that planning today is not what it Wipperling, FACMPE, practice used to be. Whereas organizations once High-Risk Prostate Dennis administrator with Surgical Specialists had 5-year plans, these plans are much of Minnesota, Minneapolis, spoke shorter now, necessitated by the many Cancer at the Medical Group Management changes coming from Washington, DC.

Dennis Wipperling, FACMPE

By Phoebe Starr

Continued on page 10

San Francisco, CA —Radiation added to hormone therapy with antiandrogens extended cancer-specific survival, as well as overall survival, when used as the Sophie D. Fosså, MD, primary treatment PhD of patients with locally advanced or high-risk prostate cancer. In the Scandinavian Prostate Cancer Group VII study, 10- and 15-year survival improved by more than 50% in patients who received radiation Continued on page 4

The Cost of Using Free Images for Your Website

By Caroline P. Wallitt, Esq; and Jennifer A. Kirschenbaum, Esq

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racticing medicine is no longer exclusively characterized as providing patient care. A physician is now required to be a skilled clinician, a marketing guru, an entrepreneur, an accountant, and a legal savant, given the level of financial hurdles and oversight that is required to run a successful practice today. With the advent of dig-

ital media marketing, a physician must also now add “web designer” to his or her skill set. While private practitioners and institutions may have little in common in the way of operations, a common factor between them is that each seemingly must have a website or other online presence in order to compete in today’s marketplace.

Continued on page 18

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N TIO A Y M R G T...16 FO LO ith I N I O w H HN Up T L A TEC ping E e H Ke

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 or 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

y 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 ears to determine what they are willing o trade for a reduced risk of prostate ancer–related death or to avoid unnecssary procedures and treatment.

Men with more education had a lower robability of opting for prostate cancer creening. 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 r to pay, on average, €188 (in 2010 In US your background a urology practice it’s likely there’s one stablishing a as patient-centered and Health manager, Information Technology uros—equivalent to $245 in 2010 approach is rapidly becoming a core for Economic and Clinical Health ollars) annually, for a 10% reduced risk business experience—and maybe more—that practice managers across requirement in US medical prac- (HITECH) requirements all have comf unnecessary biopsy or treatment. tices. would Medical home models, accountponents of engaging patients in their “Physicians should be aware that men,nation the 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

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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 r H ce ancillary products and services into your practice as generator.

E a nrevenue 6 O

PR ©2013 Engage Healthcare Communications, LLC

Send us your ideas!

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a 1 C ... te iew a t rv os e Pr Ov

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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

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 Director Dalia Buffery dbuffery@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 Adding Radiation to Antiandrogen Hormone Therapy Extends Survival in Patients with High-Risk Prostate Cancer…....................................................1

By Phoebe Starr

Controlling Your Practice’s Destiny.........................................................................1

By Sandra Paton

The Cost of Using Free Images for Your Website..................................................1

By Caroline P. Wallitt, Esq; and Jennifer A. Kirschenbaum, Esq

Enzalutamide Extends Survival in Previously Untreated Metastatic Prostate Cancer.................................................................................................6

By Phoebe Starr

The Cancer Genome Atlas Project: Newly Discovered Molecular Alterations in Bladder Cancer May Lead to Novel Therapies….....................7

By Phoebe Starr

Treatment of Patients with Penile Cancer Often Inappropriate in the United States.......................................................................................................8

By Phoebe Starr

Market Power—Increasing Your Leverage.....................................................13

By Sonia Cicero

Keeping Up with IT Solutions.............................................................................16

By G. Amrit Khalsa

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.

February 2014

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Genitourinary Cancers Symposium

Adding Radiation to Antiandrogen…Continued from the cover plus hormone therapy versus hormone therapy alone, according to an updated analysis presented at the 2014 ASCO Genitourinary Cancers Symposium.

sule was considered inoperable, she continued, and although surgical techniques have improved since then, surgery is not typically used in Scandinavia for these patients.

“The combination of radiotherapy and hormone therapy more than doubled the 10-year and 15-year survival rate and confirms that this approach should be a standard curative option for men with this type of prostate cancer who have at least another 10-year life expectancy.”

—Sophie D. Fosså, MD, PhD

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Over time, the survival difference between the 2 arms grew larger. A 2009 analysis of this study showed that at 8 years, prostate cancer–specific mortality was reduced by 12% in the group receiving radiation plus hormonal therapy versus hormonal therapy alone.

Lead investigator Sophie D. Fosså, MD, PhD, Professor and Senior Researcher, Department of Oncology, Oslo University Hospital, Norway, explained that the study was initiated in 1996, when the standard therapy for locally advanced or high-risk prostate cancer was lifelong hormonal therapy alone; it is still standard in Scandinavia. “Lifelong therapy with antiandrogens improves survival,” Dr Fosså said.

At the time the study was initiated in 1996, prostate cancer that extended through the prostatic cap-

“The combination of radiotherapy and hormone therapy more than doubled the 10-year and 15-year survival rate and confirms that this approach should be a standard curative option for men with this type of prostate cancer who have at least another 10-year life expectancy,” Dr Fosså told listeners at a press cast.

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Updated, Long-Term Results The updated analysis was based on 11 years of observation of mortality data from the Norwegian and Swedish death registries. The 875 patients enrolled in the trial (aged <75 years) had locally advanced or high-risk prostate cancer, and a prostate-specific antigen level ≤70 mg/L. Patients were all in relatively good health, Dr Fosså said.

Both arms received medical castration alone for 3 months, and

February 2014

patients were then randomized to standard treatment with lifelong antiandrogens or to the same hormonal treatment plus radiation, consisting of 70 Gy to 74 Gy, to the prostate. That dose is considered high compared with doses used in the United States.

The 10-year prostate cancer– specific mortality was reduced by more than 50% when radiation was added—19% for antiandrogens alone versus 8% for antiandrogens plus radiation. The difference between the 2 arms was even greater at 15 years—31% mortality rate with antiandrogens alone versus 12% with the combination of radiation plus antiandrogens.

Looking at overall mortality, hormones plus radiation achieved superior results, but the gap between the 2 arms was narrower than for prostate cancer–specific mortality, because many patients died from other diseases, Dr Fosså added. The 10-year overall mortality rates were 35% for antiandrogens and 26% for the combination; the 15-year overall mortality rates were 57% and 43%, respectively.

Safety Both treatment arms were associated with the adverse events that would be expected with these therapies, including impaired sexual function and bowel problems.

Press cast moderator Charles J. Ryan, MD, Associate Clinical Professor, Department of Medicine (Hematology/Oncology), University of California, San Francisco, said that this study was interesting, because the outcomes continued to improve over time, which is different from many other randomized trials. Dr Ryan emphasized that the men in this study received antiandrogens—not lifelong medical castration. l

Genitourinary Cancers Symposium

Enzalutamide Extends Survival in Previously Untreated Metastatic Prostate Cancer

Delays need for chemotherapy in asymptomatic patients

By Phoebe Starr

San Francisco, CA—Enzalutamide (Xtandi) prolonged survival and delayed radiographic progression of disease in men who had not received chemotherapy for metastatic castration-resistant prostate cancer (mCRPC). The complete results of the phase 3 PREVAIL trial were presented at the 2014 Genitourinary Cancers Symposium.

An interim analysis in 2013 was so favorable that the trial was halted prematurely, and all patients receiving placebo were offered enzalutamide. The drug was approved by the US Food and Drug Administration (FDA) in 2013 for the treatment of patients with mCRPC who had received previous therapy.

“Enzalutamide provides clinically meaningful benefit for men with mCRPC. It is approved by the FDA in men previously treated with docetaxel, but not yet approved for use prior to docetaxel. If it does get expanded approval for this indi-

Key Points • Enzalutamide improved survival and delayed radiographic disease progression in chemotherapy-naïve men with mCRPC • In the PREVAIL trial, the drug reduced the risk of death by 29% and of radiographic disease progression by 81% • Enzalutamide also delayed the need for chemotherapy by a median of 17 months and was well tolerated overall • In addition to improving survival, enzalutamide offers a subset of men with mCRPC an important clinical benefit of avoiding chemotherapy for a significant period of time

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cation, it is likely to become an important standard option for use in patients with asymptomatic or minimally symptomatic advanced prostate cancer,” said lead investigator Tomasz M. Beer, MD, Deputy

graphic disease progression—enzalutamide reduced the risk of death (ie, improved survival) by 29% (hazard ratio [HR], 0.76; P <.001) and the risk for radiographic disease progression by 81% (HR, 0.86; P <.001).

“Enzalutamide provides clinically meaningful benefit for men with mCRPC. It is approved by the FDA in men previously treated with docetaxel, but not yet approved for use prior to docetaxel. If it does get expanded approval…it is likely to become an important standard option.”

—Tomasz M. Beer, MD

Director, Knight Cancer Institute, Oregon Health and Science University, Portland.

Between September 2010 and September 2012, the PREVAIL trial included 1717 patients with asymptomatic or mildly symptomatic mCRPC who had not received previous chemotherapy. They were randomized to enzalutamide or to placebo plus standard hormone therapy between September 2010 and September 2012.

Improved Survival For the coprimary end points of the trial—reduced mortality and radio-

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February 2014

Enzalutamide slowed or halted tumor growth in 59% of the patients, based on the overall response rate (using imaging of soft-tissue disease), totally 20% complete responses and 39% partial responses compared with 5% response in the placebo group (P <.001).

Of note, enzalutamide delayed the need for chemotherapy by a median of 17 months: the median time to chemotherapy was 28 months in the enzalutamide group versus 10.8 months in the placebo arm (HR, 0.35; P <.001).

“This is important from a pragmatic perspective. Many men don’t

Genitourinary Cancers Symposium

want to take chemotherapy, especially if they are asymptomatic or mildly symptomatic,” Dr Beer emphasized.

Charles J. Ryan, MD, Associate Professor of Clinical Medicine, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, the moderator of the press cast where these data were discussed, emphasized that this study breaks new ground for enzalutamide in chemotherapy-naïve patients with mCRPC. “The interim analysis showed benefit in this patient group, and this is an important study in our field,

to be sure,” Dr Ryan said.

Dr Beer said that abiraterone (Zytiga) and enzalutamide have shown benefit in docetaxel-naïve patients with metastatic disease, but at present there are no head-to-head comparisons to guide treatment selection. Decisions should be made on an individual patient basis, he advised.

the most common adverse events (AEs; seen in ≥20% of patients) reported included fatigue (36% with enzalutamide vs 26% with placebo), constipation (22% vs 27%, respectively), back pain (27% vs 22%, respectively), and joint pain (20% vs 16%, respectively).

Grade ≥3 AEs were reported in 43% of the enzalutamide group versus 37% of the placebo group. In both arms, 6% of patients discontinued treatment because of AEs. Further studies comparing these treatments and sequencing them are needed, as well as studies earlier in the disease process, Dr Beer noted. l

Safety The safety observation was 3 times longer with enzalutamide, reflecting longer duration of treatment in this arm, he continued.

Enzalutamide was well tolerated after 17 months of treatment, with

The Cancer Genome Atlas Project: Newly Discovered Molecular Alterations in Bladder Cancer May Lead to Novel Therapies San Francisco, CA—Researchers have successfully completed a comprehensive characterization of molecular alterations in muscle-invasive urothelial bladder carcinoma as part of The Cancer Genome Atlas (TCGA) project. The results of the analysis were presented at the 2014 Genitourinary Cancers Symposium

by Jonathan E. Rosenberg, MD, Section Chief, Non-Prostate Program, Genitourinary Oncology Service, Memorial Sloan-Kettering Cancer Center, New York, and published simultaneously online (The Cancer Genome Atlas Research Network. Nature. 2014 January 29 [Epub ahead of print]).

Excitement about the discoveries was palpable at the meeting, and the investigators hope that this effort to characterize the genomic features in bladder cancer will lead to the development of new therapies targeted to actionable muta-

tions that could improve outcomes for appropriately selected patients.

“We are not in our infancy, but you could say we are on the verge of adolescence” in terms of this, said Dr Rosenberg. Bladder cancer has

(FDA) for prostate cancer and for renal cancer, but no new drugs for bladder cancer have been discovered since the 1970s. The hope is that TCGA research will lead to filling this unmet need.

“Results paint an intricate picture of the multiple molecular players altered in this potentially lethal type of the disease, but they also bring to light promising actionable targets that may lead to more personalized therapeutic options beyond cisplatin-based chemotherapy.”

—Jonathan E. Rosenberg, MD been the “stepchild” when it comes to the development of new drugs.

There has been an explosion of new therapies approved by the US Food and Drug Administration

February 2014

The TCGA Bladder Cancer Working Group successfully analyzed samples from 131 high-grade muscle-invasive urothelial carcinoContinued on page 8

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The Cancer Genome Atlas Project…Continued from page 7 mas not previously treated with cytotoxic chemotherapy.

“Results paint an intricate picture of the multiple molecular players altered in this potentially lethal type of the disease, but they also bring to light promising actionable targets that may lead to more personalized therapeutic options beyond cisplatin-based chemotherapy,” Dr Rosenberg stated.

Analysis of the tumor tissue revealed multiple abnormalities with a high mutation rate. The research team found that each tumor, on average, featured 302 exon mutations, 204 alterations in DNA copy number, and 22 largescale genomic arrangements. This represented 7.7 somatic mutations per megabase, Dr Rosenberg explained, which is second only to lung cancer and melanoma.

Cigarette smoking did not correlate with the mutations identified.

Significant Genetic Alterations Sifting through the wealth of data, 32 genes were identified that

showed significant levels of recurrent mutation. Some of the genes have been implicated in other cancers, such as p53, PI3CA, ATM, and HER2, but several genes have not been identified previously in any cancer; these include CDKN1A, ERCC2, RXRA, ELF3, and KLF5, among others.

Potential targets were identified in 69% of the bladder cancer tumors, including 42% with targets in the PI3K/AKT/mTOR pathway, and 45% with targets in the RTK/MAPK pathway (including ERBB2).

Three clusters of abnormalities were identified based on an integrated analysis of mutations and copy number: a genomic amplification cluster, a P16-deleted cluster, and a p53-mutated cluster. Dr Rosenberg said that the clusters suggest that discrete oncogenic mechanisms may be implicated in the development of muscle-invasive bladder cancer, but it is not clear if this finding has clinical applicability.

The 2 key messages from this massive undertaking are:

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The majority of patients with muscle-invasive urothelial bladder carcinoma have actionable mutations that can be targeted with FDA-approved drugs or with investigational agents in appropriately selected populations

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Epigenetic regulatory genes are frequently altered in this type of bladder cancer, suggesting another therapeutic approach with drugs that target these alterations Of the tumors investigated, 76% had 1 inactivating epigenetic mutation, and 41% had 2.

This research opens the door for new opportunities to study FDAapproved drugs and investigational therapies that can target some of the molecular alterations that have been identified in this research.

Clinical trials must be carefully designed for this purpose, Dr Rosenberg said.

Urothelial carcinoma of the bladder is associated with significant morbidity and an estimated 150,000 deaths annually worldwide.—PS l

Treatment of Patients with Penile Cancer Often Inappropriate in the United States

By Phoebe Starr

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San Francisco, CA—Penile cancer is not very common in the United States, but it can be potentially fatal and appropriate treatment is crucial. A new, large population-based study showed that the management of patients with penile cancer in the United States is often not in line with current guidelines, including the 2013 National

Comprehensive Cancer Network (NCCN) clinical guidelines for the management of penile cancer.

These findings were presented at the 2014 Genitourinary Cancers Symposium by lead investigator Elizabeth Kate Ferry, MD, Urology Resident, Case Western Reserve University/University Hospitals Urology Institute, Cleveland, OH.

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In the United States, approximately 1570 new cases of penile cancer are reported annually, as well as 310 deaths. In Africa, Asia, and South America, the incidence approaches 10%.

The results of this study show that patients with late-stage, potentially fatal penile cancers are being undertreated, whereas those with more

Genitourinary Cancers Symposium

benign, early-stage penile cancers are being overtreated, according to Dr Ferry. These findings further indicate that urologists managing patients with this type of cancer, as well as surgical oncologists, need to raise their level of awareness to updated guidelines and what treatments are actually recommended for what stage of penile cancer.

Study Details The study was based on the National Cancer Data Base, and included data on diagnosis and firstcourse surgery by disease stage in all US hospitals, including comprehensive cancer centers, community hospitals, and teaching research hospitals, between the years 2000 and 2010. The data were grouped into no surgery, penile-sparing surgery, and radical surgery.

First-course surgeries were performed in 1405 patients in community hospitals, 3930 in comprehensive cancer center hospitals, and 3667 in teaching research hospitals during the study period. No change in the patterns of surgical management was observed during the study period in patients with high-risk or low-risk penile cancers, even though clinical guidelines have been updated.

Parallel with this observation, there has been no change in survival trends among patients with penile cancer, according to Dr Ferry and colleagues.

The data revealed that surgeons

are not following NCCN guidelines for penile cancer. Undertreatment was seen in variable but high rates of penile-sparing surgery, which were performed in patients with advanced

Key Points • Approximately 1570 cases of penile cancer are reported annually in the United States • The treatment of this patient population is often suboptimal, regardless of type of treating clinic or hospital • Overtreatment of early-stage penile cancer with radical surgery and undertreatment of late-stage disease with penile-sparing procedures are common • Urologists and oncologists must become aware of current treatment guidelines for the different stages of penile cancer to improve patient outcomes

“The biggest challenge in moving the field forward is the paucity of cases to allow completion of randomized, definitive trials of chemotherapy.”

HealthCare System, Charlotte, NC, reviewed the progress in treating penile cancer over the past century.

The most important advances in the recent century related to penile cancer management, according to Dr Raghavan, are: • The use of Mohs surgery for carefully selected patients with superficial penile cancer • Combination chemotherapy with cisplatin, methotrexate, and bleomycin • The discovery that human papillomavirus infection in men is linked to an increased risk for penile cancer.

“The biggest challenge in moving the field forward is the paucity of cases to allow completion of randomized, definitive trials of chemotherapy,” Dr Raghavan emphasized. l

—Derek Raghavan, MD, PhD penile cancers at all types of hospitals; undertreating this population places these patients at an increased risk for cancer-related death.

By contrast, the investigators found a persistent pattern of overtreatment for patients with stage I penile cancer, using radical surgery, an inappropriate type of surgery for this stage of cancer; the overtreatment trend was evident again at all hospitals.

Advances in Penile Cancer Management Also at the meeting, Derek Raghavan, MD, PhD, President, Levine Cancer Institute, Carolinas

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February 2014

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Medical Group Management Association Conference

Controlling Your Practice’s Destiny Continued from the cover Strategic Planning and Implementation Mr Wipperling cautioned that although strategic planning is one thing, it is equally impor­ tant to develop a way to achieve the goals your organization has identified. “Strategic planning is the process, but then you need to talk about implementation,” he said. Mr Wipperling referred to an old adage to emphasize his point: “Organizations don’t plan to fail.

They fail to plan.” He illustrated this by describing the machinations of one organization that developed a 5-year strategic plan, 7 years ago.

At the time, the organization had identified 5 priorities, but had managed to accomplish only 3 of them in 7 years. When he joined the group, it had begun the planning process, but shortened its vision from 5 years to 3 years. Eventually, he predicted, it would shorten the range to only 6 months.

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Why Have a Strategic Plan?

A strategic plan is a process that begins with a vision that leads to an outcome. In other words, where does your practice want to be in 2 or 3 years? This process begins with gathering information, and necessitates defining goals along the way.

The planning process must also be dynamic, one in which change is inherent, especially in today’s quickly evolving healthcare world.

All organizations must begin with a vision. Mr Wipperling illustrated this need with 3 case studies. In the first, a pulmonary specialist group that he helped transition to close to St. Paul, MN, once had a vision to be the predominant pulmonary critical care group and sleep medicine provider in the eastern part of the Minneapolis–St. Paul metropolis. Indeed, they once dominated

the market there, covering all of the intensive care units and all of the large health systems in St. Paul. But then, things began to change. The hospital began to make changes and decisions that made the pulmonary group’s vision obsolete. Payers began to drive the changes. And with Obamacare in the works, the entire healthcare system changed rapidly. Soon enough, the group found itself with a failed vision and faced the prospect of having to close its doors. Thus, “now more than ever, strategic planning is a must,” Mr Wipperling observed.

In the second case, a physician wanted to start her own practice.

Her ideas were not well conceived and she jumped from one idea to the next before the practice even had a sufficient infrastructure to build upon. Practice administrators spent most of their time doing damage control and putting out fires rather than helping the organization realize its vision. Within a 5-year period, the practice lost 13 providers. Although the practice is still in business today, they have lost a considerable amount of time and money in the process because of a lack of discipline, focus, and planning.

A third case illustrated how a comfortably established and predominant specialty group, in business for more than 20 years, finally faced competition in the form of the hospital system for which it had been the primary provider. The hospital system became the entity introducing the competition. The practice had not felt that it needed a strategic plan, because they had operated without one for many years. As the competition from the hospital increased, the practice diminished greatly and is even now continually losing revenue.

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February 2014

How to Form a Strategic Plan To form a strategic plan, it is necessary to first define your practice’s capabilities and determine how it can accomplish its vision. Referring back to the pulmonary practice, Mr Wipperling noted that its initial vision was to be the predominant player in its market. And indeed, for a time, it was. It provided value to the community. But for the first time, and because of a set of rapid changes, this successful practice had to completely regroup and reassess the position it was in. It was forced into a reactive position because of its lack of anticipation in a quickly changing marketplace. What had worked for the practice in the past no longer applied.

This is especially true of any medical practice today. What was important even 2 years ago—electronic health records, access to care, and reimbursement—has been replaced with new issues, including pending retirements, hospital coverage, compensation and productivity, and staffing shortages.

What things still apply are a practice’s core competencies. Practices must know what they do well. In view of the current environment and even more impending changes, practices must know their priorities, have a strategic plan for coping with the changes, and be able to make sense of it all.

“One thing that should not change is your mission,” Mr Wipperling observed. “You are here to take care of a population and provide healthcare. Bear in mind that what is not working is just as important as what is working.

Prepare to adjust your vision to make a course correction.” The pulmonary practice in St. Paul did not Continued on page 12

Medical Group Management Association Conference

Controlling Your Practice’s Destiny Continued from page 10 particularly like the change that occurred, but it had no choice. He recommended conducting a SWOT (strengths, weaknesses, opportunities, and threats) analysis to help

for one practice revealed that the physicians worked well together (an attribute that ranked high on the survey), but lacked a unified vision (an attribute that ranked low on the

“One thing that should not change is your mission. You are here to take care of a population and provide healthcare. Bear in mind that what is not working is just as important as what is working.” ­—Dennis Wipperling, FACMPE

gather the information necessary for them to switch gears: • Strengths: Know your core competencies • Weaknesses: Determine where your organization is most vulnerable • Opportunities: Determine what your organization should be doing that it is not doing now and identify unmet needs • Threats: Identify problems that might pose a threat to your longterm success.

The pulmonary associates were unaware—and, therefore, unprepared—that their strongest business partner (the hospital) would eventually wind up becoming their fiercest competitor.

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Surveys, Plans, and Priorities Surveys can be very useful in helping to map out the planning process and identifying potential problems.

Mr Wipperling shared that a survey

survey). This dichotomy showed the lack of a common vision and illustrated the need for a course correction.

He urged practices to align their priorities over the next 2 years especially. Determine which priorities are most important and attach a time line to each. But most impor­ tant, limit the priorities. Having a 7-year plan might sound impressive, but in today’s environment, it makes little sense. Limit your priorities to what will have the greatest impact on your practice, and be realistic. Develop an action plan for each priority, which should include identifying the specific steps to take, establishing the time frames for accomplishing each step, assigning who will be responsible for achieving each step, and creating a review process to determine how successfully each priority has been achieved.

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February 2014

Mr Wipperling strongly suggested reviewing each measure regularly.

He recalled how one practice had identified access for new appointments as one of its greatest challenges. The practice’s staff members determined how many new patients they wanted to see each month, and set this number as their goal.

Then they developed measures and a responsible plan that required frequent reporting. They also planned out what they would do if their vision failed: They would visit their referring physicians and identify practices that had not yet referred patients. Everyone in the practice was to play a role in the process, including the scheduler. All systems and processes would be aligned with the practice’s priorities, including same-day appointments for new patients, ensuring excellent experiences for new patients, and following up with new patients and referring physicians.

All plans require a debriefing process during which practices should determine whether their priorities are being addressed and whether they are sufficiently following through on them. When things go well, celebration and reward should be a part of the process. When things fail, it is time to drill and engage all staff, including the receptionist and whoever else has contact with patients.

Mr Wipperling noted, “It’s about having measures and being diligent and tracking this information.

It’s about transparency, feedback, rewards, and celebrations.” Above all, he observed, “It’s important to ask if we are accomplishing our goals and, if not, what or who is keeping us from doing so?” During this time of unprecedented healthcare changes, practices do not have the luxury of lying down and waiting for something to happen. l

Medical Group Management Association Conference

Market Power—Increasing Your Leverage

By Sonia Cicero

San Diego, CA—Randy W. Cook, MPH, FACMPE, president and CEO of AmpliPHY Physician Services, Columbia, TN, offered some hope to listeners at the Medical Group Management Association’s annual conference. His message: “You have more leverage than any health plan will tell you about.”

He told a story about a 2-physician practice in rural Kentucky. The practice had begun as a regular family practice; however, several years ago, they classified themselves as a World Health Clinic. In doing so, the State of Kentucky and the Centers for Medicare & Medicaid Services were obliged to pay their costs; in fact, their average rate for Medicaid was 167% of Medicare. When Humana approached the 2 physicians and offered 105% of Medicare, they sagely declined. “The physicians focused their leverage. Leverage is about market power.”

Having market power means that you are getting something above and beyond what the rest of the marketplace is getting. “Any practice can increase leverage, even if it is a single-physician practice in rural America,” Mr Cook noted. He cautioned that although most practices might be inclined to shrug off his suggestions because of other issues (“my practice is too small,” “my concern is getting more patients”), it is important to “maximize what you already have.”

Research the Market As practice managers and administrators, you should be basing all of your decisions on facts and data, including how many physicians are providing the same services in your market, how many physicians in the same specialty are in your territory, and how many physicians in your

specialty your marketplace needs.

Mr Cook suggested using Google and your community’s Chamber of Commerce to get a handle on these answers. First, determine the number of citizens and the per capita income and average age of the citizens in your geographic area.

Use Google to identify 10 similar communities (rural, suburban, or city—whichever applies) around the nation that have populations

a service issue, an access issue, or a geographic issue, and if you are over- or undersupplied.” Whatever you do, he cautioned not to make any decisions based on only 1 piece of data.

Do Patients Seek Your Practice by Name?

Conduct a SWOT analysis, which is a planning method that can be used to identify your practice’s strengths, weaknesses, opportunities, and threats. Doing this kind of analysis, Mr Cook noted, requires honesty and courage: You will need to admit your faults, including whether your practice is in the wrong place. Mr Cook related a story about an ob/gyn practice in Georgia that covered 50% of the market. They decided to build their own building, bought cheap property on the other side of town, and lost 30% of their business. The property they had purchased was “on the other side of the tracks” and patients whom they had seen for 30 years refused to go there. “The practice did not think carefully about their real strengths and weaknesses,” he observed.

Primary care orientation and geographic isolation work hand in hand to bring patients to your practice. Primary care orientation indicates the degree to which patients seek your practice by name; that is, the degree to which you care for the whole patient, including customer service and access. Health plans need members who insist on going to your practice. Geographic isolation is more than just being in a specific area; rather, it is about being the only type of practice that caters to a certain demographic in your market. If you are the

“You have more leverage than any health plan will tell you about. The physicians focused their leverage.

Leverage is about market power.”

—Randy W. Cook, MPH, FACMPE

with similar socioeconomic status, age range, and demographics. Then use Google to research the number of physicians in your specialty. If you are an ob/gyn, you will want to know the birth rate in your area. If you are in rheumatology, you will want to know how many citizens are on Medicare. For further pertinent local information, contact the hospital business office.

Mr Cook further suggested profiling communities similar to your own around the nation to “see who is being treated, where they are being treated, who your local competitors are, and whether you are taking their business or they are taking yours. Then determine if there is

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Continued on page 14

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Medical Group Management Association Conference

Market Power—Increasing Your…Continued from page 13 To Recruit or Not to Recruit A practice of 4 internists assumed they needed to hire another physician to replace 1 who was retiring. They were operating at 95% of their possible capacity. In the community, 4 other physicians served nearly the entire community; thus, the first group did not have quite enough capacity. Their rates were poor, and they had not revised their payer contracts in 5 years. In fact, they were afraid to say “no” to health plans.

Blue Cross comprised 20% of their business. The rates were horrible. Without the Blue Cross patients, they would have excess demand, increasing their average rate. When they tried to negotiate with Blue Cross for $120,000 more, the insurer said the rate they were given was better than they had ever given anyone else at the time: “Take it or leave it.”

The practice, gaining courage, decided to leave it, as they had recently met with the medical director from Blue Cross, who noted that Blue Cross was saving $500,000 per year because their practice was in the network. Eventually, Blue Cross came back and offered the practice 18%. The prac­tice had originally asked for only 16%.

As you prepare to negotiate with your health plans, ask them to profile your practice and tell you how it is doing on a cost basis relative to your competitors. This practice eventually hired a nurse practitioner, instead of another physician. They were able to not only cover the division problem (4 instead of 5 practitioners), but they also made more money: Individual compensation increased by 7%.

You need to stimulate demand, but you also need to manage capacity, and you need to position yourself to have slightly more demand than capacity. Practices with excess capacity generally grow. only rheumatologist for miles, the health plans have no choice but to purchase your services, providing

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you with leverage. Mr Cook related another story to illustrate this point. It involved moving a practice, but this time, the move was well advised. A Korean physician originally set up his office in an affluent section of town, “where the good insurances were.” But, because his name was Korean, he had trouble filling his practice. He was finally persuaded to move his office to a Korean area of town where there were few other physicians, none of

“Use it to know what to ask for. Know what to ask for and who to ask in your practice system. Know your costs. Know your volume. Know your competitors.”

—Randy W. Cook, MPH, FACMPE whom spoke Korean. In doing so, he created a mini-market. As the only doctor supplying that community, he increased his negotiation skills with the insurers. He was able to name his own price because he was the only practice in an underserved community.

Improving your geographic lo­cation can help you to increase de­­ mand and leverage with insurers.

“Bear in mind that you may have more leverage than you think and you probably also have more lev­ erage than insurers are likely to admit,” Mr Cook said.

Capacity and Demand If patients are waiting at your door

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and your practice is working at full capacity, the only opportunity you have to increase your profits is to either get paid more or lower your costs. Growth can be problematic if it outpaces demand, because it weakens your ability to insist on a price.

Thus, capacity is a strategic issue.

For practices operating at maximum capacity, providing more services will increase costs, not revenues. Thus, it is important to assess demand; that is, the ratio of new patient visits to all patient visits over a certain period of time. Furthermore, it is impor­ tant to know what the marketplace demand is apropos to your capacity. An increasing Medicaid patient list is a leading indicator that you have excess capacity. Be aware that patients who request their medical records might be preparing to leave the practice. Thus, it is important to survey these patients. If a patient is moving to another practice because there is a problem, you need to find out what that problem is and tend to it.

Use Data to Your Advantage Show health plans your data.

“This is your big hammer,” Mr Cook noted. “Your practice is the source of this data, giving you an advantage.”

Healthcare data are generated every time you post a charge, every time you post something on someone’s electronic medical record, every time you post a payment, and every time you post a deposit. Mr Cook outlined a plan for the audience: “Use it to know what to ask for. Know what to ask for and who to ask in your practice system. Know your costs. Know your volume. Know your competitors.

Do a reimbursement analysis and you will know immediately what kind of payment rate you should ask health

Medical Group Management Association Conference

plans for. If a health plan sends you 2 patients a year, you would not accept the same rate for them as you would for a plan that sends 40% of your business.”

He noted that data should tell you what to ask for. “Use it to increase confidence in your practice; build internal support so that you have something to back into in the heat of battle. Test and measure any challenges to your plan. Make compelling arguments and take control over the discussion. But let the facts, the data, speak for you.

Let the data take the conversation to the conclusions you have already reached,” Mr Cook counseled.

He offered 2 possible scenarios for negotiating rate increases:

1

Seek a meeting with your lowest-paying health plan and ask for a rate increase. Tell the plan’s representatives honestly that they are your lowest payer and that unless they give you a specified increase (based on the chart you show them), you will terminate your relationship with them. If they come back with an inadequate rate increase, refuse it on the basis that it will not cover your costs.

2

Schedule a meeting with your health plan’s representatives and explain that you have completed an analysis that you are eager to share.

Make clear that you expect the increase you noted on your chart.

Furthermore, explain that you will terminate if you do not get the rate you are seeking. Then show them the data to illustrate your point; for example, you bought $7000 in services last year for which you paid an average of 103%, totaling $270,000 and costing you 113%. Explain that your average rate from all other plans, not including theirs, is 127%, noting, “That’s how far apart from the rest of the marketplace you are.” The plan will complain that

their contracted rate is actually much better than 103%. In fact, it’s 120%. You then explain, “I know, but your policies reduce reimbursement to 103%. And I don’t have to take 103%. Here’s the math. Here are the figures.”

In both scenarios, you took control of the conversation with your data. “If a plan says they cannot afford to pay any more than what they are currently paying,” be aware that this translates as “we cannot

The Semantics of Managing Payers In answer to a question about being legally allowed to restrict scheduling based on insurance, Mr Cook related this story: “I called Medicare twice. The first time, I asked if I could discriminate which patients I see based on whether they had Medicare or not? The answer was a resounding ‘No.’ Ten minutes later, I called back and asked, ‘May I manage how many Medicare patients I see, so that I have only a certain percentage of Medicare patients in my practice?’ The answer was ‘Yes.’ Medicare cannot control how many Medicare patients you see. They also cannot prohibit you from managing your payers.”

“Establish your strategy and base your decision on facts and figures.”

—Randy W. Cook, MPH, FACMPE

Referrals Most practices are not as dependent on referrals as they think. Group A includes your loyal customers who will continue to send you referrals for everything.

Group B sends you some of their business, but not all of it. Group C only sends you 3-headed, 2-toed patients with Medicare.

The group you need to focus on is Group B. You need to figure out why they send you only some patients. You need to tell them why they are important and treat them accordingly. Tell them why you are leaving a plan or how you would treat their patients without letting money get in the way.

earn what we want to earn if we pay you this much money,” Mr Cook explained. A practice can always terminate a plan. “When the termination letter arrives, the plan will almost always reach back out to a practice,” he said.

Whatever you do, he cautioned, “establish your strategy and base your decision on facts and figures.

Don’t just terminate all plans that are below cost at once.” Before you meet with a plan, have all of the physicians in the practice agree to your decision to terminate a recalcitrant plan. They need to give practice managers the authority to negotiate.

To increase your leverage to the maximum, you must manage your capacity to less than demand. Do everything you can to improve your market position, then dive into the data. Learn Excel if you do not already know it, and get information on the resource-based relative value scale. Get off-the-shelf help from WinZip for Windows, Adobe

February 2014

Acrobat, and Monarch. In short, gather data and conduct your analysis, then schedule a meeting with your health plan.

Use the information you have gathered as leverage. “Don’t back them into a corner. Don’t insult them. Plan your strategies carefully using your data as a guide,” said Mr Cook. “And if your data have not provided sufficient answers, keep digging.” l

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Health Information Technology

Keeping Up with IT Solutions

By G. Amrit Khalsa

A

ll urology practices are facing serious changes brought about by government and healthcare reform, some of which have not been fleshed out clearly enough. In the midst of this flux, practice managers must assess their practice’s performance and needs and make decisions that will affect the continued health and financial success of their business operations.

Calling in a practice management consultant to help your practice wade through the mountains of healthcare reform regulatory requirements—as well as to help keep your practice abreast of normal industry changes, identify opportunities for growth, and prevent potential disasters—is more of a necessity than a luxury these days. But where do you go for guidance when it comes to determining the best electronic medical records (EMRs) or electronic health records (EHRs) for your practice? Even if you are already satisfied with your system, this is no time to relax. Constant surveillance of the ever-changing technological world should now be a part of your routine, particularly where reimbursement is concerned.

You may recall the old saying, “You are what you eat.” The adage for your practice today may be better expressed by saying, “You are what your data say.” If you have accurate charge and payment data, you are halfway there. When it comes to medical information technology (IT), how fast you can supply medical records, how accurate those records are, and how good your technical support is when problems arise all play a part in this picture.

To this end, we have listed and described a few EMR software systems that you can use in your practice. Bear in mind that change is

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occurring rapidly. So even if you are satisfied with your current system, consider reviewing some of the other systems that may solve problems for your practice down the line. If IT demands are dogging your practice, keep this caveat in mind: “Keep up.” The following “bytes” were adapted from a variety of reviews.

ADP AdvancedMD ADP AdvancedMD (www. advancedmd.com) offers a blog to help improve clinical documentation and facilitate coding for International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM). The company recently released a white paper entitled, “A Case for EHR: 5 Status Quo Myths that Hold You Back and Reduce Your Bottom Line.” The idea was to urge practices to adopt change and overcome the myths that reduce their bottom line. The 5 EHR myths outlined in the paper include: • Maintaining the existing paper chart system makes sense financially • Paper charge slips are the quickest and easiest way to enter visit charges • Lost charts, orders, and notes are an unavoidable part of a busy private practice • Electronic records are not as secure as paper patient files • Portability of patient records is a luxury reserved for large practices.

Allscripts Allscripts (http://clientconnect. allscripts.com) provides EHRs for private practices, hospitals, and other healthcare providers. Their services include electronic prescribing, care management, and revenue cycle man-

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agement software. Their products are currently used by more than 180,000 physicians, 1500 hospitals, and 10,000 post­–acute care organizations.

Their website offers online client discussions (through “ClientConnect”), online learning modules, online issue or enhancement requests through their support team, web referrals, and a provider search through an extended-care database.

Benchmark Systems Benchmark Systems (www. benchmark-systems.com) offers cloud-based software featuring scheduling, EHR, practice management, and billing and collection services. Their templates are customizable and can be set up to function as your practice requires. They also provide a patient portal through which patients can access their own medical records, billing statements, and appointments. Their systems automatically receive and scrub coding information for billing and offer comprehensive revenue-cycle management services. Benchmark operates its own claims clearinghouse, complete with statement processing and electronic remittance management. A variety of administrative processes—such as billing and collection, scheduling appointments, and core accounting functions—can be outsourced to Benchmark’s “Virtual Practice Management Services.” eClinicalWorks This software is designed for ambulatory care environments. The system has been touted as usable and efficient, featuring single-click patient accessibility, mobile support, and a patient portal that allows patients to access their billing and scheduling. eClinicalWorks

Health Information Technology

(www.eclinicalworks.com) can be integrated into community or state-wide health record networks.

Their cloud-based EHR can be accessed by computer, smartphone, and tablets such as the iPad. They developed the “Care Coordination Medical Record” (CCMR), a platform that supports the components of the Affordable Care Act. The CCMR provides population health data and health alerts; cost utilization dashboards; clinical quality measures specific to patient-centered medical home and accountable care organization measures; patient engagement via apps on smartphones and patient responses at the point of care; and a patient referral and consultation network.

Epic Systems This company (www.epic.com) offers a “one patient, one record” approach to simplifying administrative duties. Their “Single Billing Office”—a single bill and payment plan—simplifies accounting, administration, patient follow-up, and can streamline back-office staffing, not to mention that it offers convenience for patients.

Patients can access their records via “MyChart,” where they can schedule appointments and access their test results. An interoperable health diary can be connected to or disconnected from MyChart as required or desired. A “Call Management” feature stores patient information and service issues in a central location, allowing users to resolve inquiries from patients and analyzing your practice’s overall customer service effectiveness.

GE Centricity EMR and Centricity Group Management Both products from GE Healthcare (www3.gehealthcare.com) work together to coordinate practice management, while offering a

Kareo The Kareo EHR (www.kareo. com) was designed by a practicing physician for use on the iPad and the web, and can keep the physician connected to a patient during an examination while taking and building patient notes. The program is integrated with third parties for prescription and lab orders. It is certified by the Office of the National Coordinator–Authorized Testing and Certification Body (ONC-ATCB). The system permits transition between the mobile and web versions without restrictions.

It was designed on a knowledge base by Epocrates to help physicians readily access clinical information.

single vendor for service and support. This system provides both clinical and financial management, from practice administration to EMRs, in large practices. It can integrate with medical devices, medical imaging, and other GE Healthcare products.

The EMR system is designed for community hospitals, academic medical centers, and integrated delivery networks. It features clinical, financial, and administrative software to help manage patient billing, revenue cycles, and closed-loop medication. The system is certified by the Certification Commission for Healthcare Information Technology (CCHIT), an independent 501(c)3 nonprofit organization whose mission is to encourage the adoption of interoperable health information technology. CCHIT certification ensures that an EHR has been thoroughly inspected for functionality, interoperability, and security of patients’ personal health information.

MediTouch This EHR can be accessed as a web-based system and touchscreen interface. It provides management for charting, medication, electronic prescribing, allergy checks, clinical orders, lab tests, and documents.

Forms are customizable. The system can be used as a stand-alone or with HealthFusion’s practice management system. It is certified by ONC-ATCB. The system is entirely hosted by HealthFusion (www.healthfusion.com), obviating installation or maintenance of software. It is accessed through a web browser and is usable on iPads, being touted as the fastest iPad EHR. It is provided via a monthly subscription, which includes all customer support and training.

Greenway Medical Technologies PrimeSUITE PrimeSUITE (www.greenway medical.com/solutions/primesuite) was designed for easy adaptability to any office’s workflow. It is based on a database that supports all EHR and practice management requirements, ensuring the seamless flow of clinical, administrative, and financial data from one to the other (ie, from registration, scheduling, revenue cycle management, and reporting). Templates are customizable.

There are currently 3500 clinical templates. Users have access to a “Clinical Content Library,” where they can share clinical information with their peers. Efficiencies have been recorded in coding improvements, elimination of transcription and chart expenses, and improved collections.

February 2014

Conclusion There are many more options specific to oncology. Most companies offer resource and support centers. Check with companies directly before making a decision about your practice’s needs. Do your homework in person and online and check with practices that are using the systems for realworld advice. l

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Medical Legal Update

The Cost of Using Free Images…Continued from the cover Whether this task is tackled by senior management or is delegated to a hired intern, many physicians are involved at least to some extent in their web­ site de­velopment and the creation and posting of marketJennifer A. ing content. Un­der­ Kirschenbaum , Esq standably, strictly sticking to substance often results in a dull website, which could potentially hamper ongoing marketing efforts and the original intended result of the marketing in the first place: to increase patient flow. To entice potential patients and referral sources, many practices seek to create website content with character, using images to add color and points of interest to the presentation. However, an often overlooked consideration is whether the images that are chosen for a website are protected intellectual property, and whether their use without permission could lead to potential exposure for an unaware user.

Empowered by recent court decisions, image owners are increasingly filing claims for copyright infringement. Under the law, anyone who violates any of the exclusive rights of a copyright owner has committed copyright infringement. The law does not require that the defendant commit the infringement willfully—the infringing act itself is enough to impose liability, meaning that a company that unknowingly uses copyrighted images without the owner’s permission can be held liable for infringement. As for damages, an infringer is liable for either: (1) the copyright owner’s actual damages and any additional profits of the infringer; or (2) statutory

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damages, which can be adjusted upward or downward based on the infringer’s culpability, or level of willfulness. Copyright owners often opt to sue for statutory damages, available only in limited circumstances, when the actual damages and additional profits are difficult to calculate.

The infringing act itself is enough to impose liability, meaning that a company that unknowingly uses copyrighted images without the owner’s permission can be held liable for infringement.

As an example, in October 2013, a jury awarded microscopic photographer Andrew Paul Leonard $1.6 million in actual damages for his copyright infringement claims against Stemtech International, Inc, a manufacturer of nutritional supplements that are sold through a network of more than 40,000 independent distributors (Andrew Paul Leonard v. Stemtech Health Sciences, Inc [C.A. No. 08-067-LPS-CJB]).

Stemtech made the fateful mistake of copying 2 images—without Leonard’s permission—for use in all of their promotional materials, including brochures, videos, DVDs, and websites. Stemtech was aware that it was using copyrighted images, because it had previously paid Leonard annual licensing fees for the use of his images.

From the facts that could be

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gleaned from the court docket as of this writing, with the official trial transcript set to be publicly released in late January 2014, this unique case epitomizes the worst-case scenario for a company that copies online images for its own use without obtaining the proper permission to use them. The jury concluded that Stemtech was liable not only for its own direct copyright infringement, but it was also liable for the vicarious and contributory copyright infringement for all of its independent distributors who had also used Leonard’s images in their marketing materials, which contributed exponentially to Stemtech’s monetary exposure. Because Stemtech’s marketing policies require that its independent distributors use only its replicated website and marketing materials to market or sell its products, Stemtech ended up using each copyrighted image abundantly for multiple years. Another factor that caused the actual damages to skyrocket was the jury’s likely acceptance of the $1500 fair market value rate for Leonard’s licensing fee, rather than the average licensing fees of ~$125 and ~$226 for each of the 2 respective images that were actually charged by Leonard during the relevant time period.

It should be noted, however, that Leonard v. Stemtech is still not over; the 2 parties are currently briefing postjudgment issues, and there is always the prospect of an appeal.

Granted, it is unlikely that another company would be liable for the $1 million-plus in damages that the jury awarded Leonard without achieving the perfect storm of damage variables—a high fair market value licensing fee, numerous instances of infringement resulting from the distributors’ use of the images in their own marketing materials, mul-

Medical Legal Update

tiple years of violations, and actual knowledge of the infringing activity. A more probable scenario is a medical practice procuring an image from the Internet and using it for its own use on its website without the awareness or knowledge of whether that image is copyrighted.

Under such circumstances, it is not unusual for such activity to result in a demand for money for copyright infringement now that copyright creators (and hungry collection agencies as well as plaintiffs’ attorneys) are able to use “web crawlers” to identify copyrighted images that are being used without permission.

In fact, some companies use these tactics to generate “robo letters” on behalf of copyright owners for collection purposes, sending demands for payment to alleged copyright infringers en masse. (In the web community, Getty Images is notorious for this practice.)It is also not unusual for such demand letters to cite copyright infringement as justification for extortion, claiming entitlement to excessive fees in exchange for warding off the threat of legal action.

Many times, the recipient of a copyright infringement demand letter is the unknowing business owner who is guilty of nothing more than haphazardly selecting images from the Internet to create a more appealing web presence. In many instances, the selected images may not contain the mandatory statutory notifier, or the copyright mark (©), which could possibly mitigate the potential exposure for statutory damages because the image is not clearly identified as protected intellectual property.

Further mitigating any potential exposure, this time for actual damages, is whether the image is used for the economic benefit of the user, and whether any profit may be tied to the image’s use, as was the case in Leonard, where the images were tied to profit because they were prominently displayed on marketing materials. Depending on the circumstances surrounding the use of a protected image, any

management, so before engaging a third party to perform such services, it is important to inquire whether the company invests in protective measures to avoid the misuse of copyrighted content, and, when possible, incorporate indemnity protection into your vendor contract with the third party against any misuse that may occur as a result of its efforts. In addition, should you find yourself in receipt of a demand letter alleging the misuse of copyrighted material, do not send a check without contacting an attorney and performing proper due diligence regarding the claim.

For a review of any contract with a third party that is responsible for content creation or management on your behalf, or for assistance/defense of any claim of copyright infringement, contact Caroline or Jennifer to discuss your options. l

Further mitigating any potential exposure, this time for actual damages, is whether the image is used for the economic benefit of the user, and whether any profit may be tied to the image’s use.

Caroline P. Wallitt, Esq, is a partner of Kirschenbaum & Kirschenbaum, P.C., and specializes in representing clients, especially those in the healthcare sector, in litigation, arbitration, mediation, and prelitigation disputes. She may be reached at 516-747-6700, x305, or by e-mail at CWallitt@kirschenbaum­ esq.com. Jennifer A. Kirschenbaum, Esq, is a partner of Kirschenbaum & Kirschenbaum, P.C., and specializes in representing healthcare clients in transactional, regulatory compliance, and general practice matters. She may be reached at 516-747-6700 x302 or by e-mail at JKirschenbaum@kirschenbaumesq.com.

For more information about the firm, visit www.kirschenbaumesq.com.

potential exposure for the misuse of such an image may range from very minimal to somewhat defensible, as it was in Leonard.

The recommended best practices that can help to avoid copyright infringement exposure entirely include either avoiding the use of copyrighted material or securing the proper licensing rights to the copyrighted material before using it. Many professionals outsource their content creation or content

Urology Practice Management is now avaible online at: www.UroPracticeManagement.com

February 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 3 Muscle discomfort 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.

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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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