MARCH 2012 VOL 2, NO 2

ONCOLOGY PRACTICE MANAGEMENT ™

PROCESS IMPROVEMENTS TO ENHANCE PATIENT CARE™

www.OncPracticeManagement.com

MARCH 2012

Technology 2.0

VOLUME 2 • NUMBER 2

From the Editor

Going Electronic Where Are We Going?

By Ruth Linné Lander, FACMPE, Practice Administrator, Columbus Oncology & Hematology Associates, OH

Does Anyone Know?

By Dawn Holcombe, MBA, FACMPE, ACHE

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ncology as a medical specialty is, and always has been, rapidly evolving. The world in which we provide care for patients is also rapidly evolving, and not always in sync with our changes. Doctors will be needed to diagnose and treat patients, but where and how that happens may look dramatically different in only 10 years. We still have the ability to shape that future, but what we do today, and every day from now on,

will help to define our role. More external forces than internal forces have already shaped our evolution to 2012 from the 1970s, as described below.

Physician Offices Replaced Hospital Centers When oncology was evolving as a medical specialty, most cancer care was delivered in hospital inpatient units. Side Continued on page 3

By Jennifer Kirschenbaum, Esq, and Erica Youngerman, Esq

Understanding the Office of Inspector General The US Department of Health and Human Services (HHS) Office of

From the publishers of ©2012 Engage Healthcare Communications, LLC

Inspector General (OIG), which is tasked with protecting the integrity of the HHS programs and operations by “detecting and preventing Continued on page 20

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nexpected and unwanted oversight is becoming a more frequent element of practice, making it imperative that you understand current investigation and audit initiatives, and how to prepare and protect your practice.

N Br T ou A g C ht N om to D m yo PR Ta un u kin b ity y O g It O Ca th VID to ra n e th l P ce As ER e ar r C so A Ne ity e ci C nt ati xt : C er on Le s of ES ve S

Continued on page 10

Understanding Office of Inspector General Initiatives and How to Prepare Your Practice

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emember the good old days? I do, and not everything was that good.

When I started post-college work, I had no calculator, no personal computer with Excel or word-processing software, no fax machine, no internet access, and no smartphone. I love technology, so I have been amazed by and embraced advances that have come along as the years have passed.

Several years ago, I heard a compelling keynote address by Newt Gingrich at the Medical Group Management Association (MGMA) national conference. He shamed us with our slow progress into the electronic medical record (EMR) arena.

Using banking as an example, he reminded us how we use our credit and debit cards everywhere in this country or

with dedicated Amgen Reimbursement Counselors There is A place you can go for user-friendly online tools and reimbursement forms… …where your coverage questions can be Answered …where online Access to forms is simple …where you can talk to A single Amgen Reimbursement Counselor for all your reimbursement activity

www.AmgenAssistOnline.com 1-888-4ASSIST (1-888-427-7478)

For insurance verification…prior authorization…patient assistance program information…billing and claims processing support…and appeals support.

Amgen Assist ® and Amgen Inc. do not guarantee success in obtaining reimbursement. Third party payment for medical products and services is affected by numerous factors, not all of which can be anticipated or resolved by our Amgen Assist® staff. ©Amgen. All rights reserved. MC48319-B-1 08/11

Making Access easier.

From the Editor

Where Are We Going?…Continued from the cover effects of cancer treatments were almost as debilitating as the treatments themselves. While we were looking for medical solutions to fight cancer, hospital-based diagnosisrelated groups (DRGs) came along in 1984, and a low price for the chemotherapy DRG encouraged hospitals to shift cancer care into the outpatient setting of the hospital, where it predominantly remained until the US Food and Drug Administration (FDA) approved drugs such as ondansetron (Zofran) starting in 1991. These drugs allowed us to manage side effects of toxic cancer drugs in a far more controlled manner, and fueled the growth of physician offices with infusion suites that functioned as acute care medical centers in the community setting. Specially trained physicians and nurses streamed away from hospitals into these community offices, and pretty soon, about 80% of all cancer care (and clinical

Physician Rates Lagged Behind Current Models During the same time period, federal policy changes regarding healthcare reimbursement for all services occurred, which, although not focused on oncology, had a far-reaching effect on cancer care. In the midto-late 1980s, the resource-based relative value system (RBRVS) was created. After a market review, the RBRVS established physician and practice work and expense codes for each medical specialty; these codes and valuations defined a sweeping change in professional services reim-

Buy and Bill Evolved for Efficiency and Stayed by Default to Cover Practice Costs Oncology physicians, like the hospitals from which they came, bought cancer drugs from distributors, treated patients, educated patients on symptoms and side effects, and then billed the insurer for the treatment Continued on page 6

Editorial Advisory Board

Editor-in-Chief Dawn Holcombe, MBA, FACMPE, ACHE President DGH Consulting South Windsor, CT

Bruce A. Cutter, MD President Cutter HealthCare Consulting Spokane, WA

Ronald Barkley, MS, JD President Cancer Center Business Development Group Bedford, NH

Craig Deligdish, MD Medical Director Florida Comprehensive Cancer Network Melbourne, FL

Peggy Barton, RN Practice Manager Toledo Clinic, OH

Patrick A. Grusenmeyer, ScD, FACHE President Christiana Care Health Initiatives Newark, DE

Risë Marie Cleland President Oplinc, Inc Lawton, OK

bursement by 1989 for all medical specialties. The problem for oncology was that only 2 years after the RBRVS was calculated and put into process, the community oncology office evolved. Consequently, the care scenario on which the RBRVS rates were based ceased to exist and was no longer representative of the new model that had emerged.

Professional codes and reimbursement rates for oncology services never caught up to the reality of the practicing model.

research trials) was being provided in these community settings. Many hospitals completely closed their outpatient infusion centers, and often made collaborative arrangements for community medical oncology practices to create what looked like integrated cancer centers to the general patient.

Teri U. Guidi, MBA, FAAMA President & CEO Oncology Management Consulting Group Pipersville, PA Ruth Linné Lander, FACMPE Practice Administrator Columbus Oncology & Hematology Associates, Inc Columbus, OH Bonnie J. Miller, RN, BSN, OCN, FAAMA Administrative Director Women’s Cancer Center Fox Chase Cancer Center Philadelphia, PA

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Cindy C. Parman, CPC, CPC-H, RCC CSI Coding Strategies Inc Powder Springs, GA Jeffrey A. Scott, MD Senior Vice President Cardinal Health Dublin, OH Carla C. Wood, CPC, MS President Altos Solutions, Inc Los Altos, CA

www.OncPracticeManagement.com

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In This Issue

PUBLISHING STAFF Publisher Nicholas Englezos nick@engagehc.com 732-992-1884 Associate Publisher Maurice Nogueira maurice@engagehc.com 732-992-1895 Associate Publisher Cristopher Pires cris@engagehc.com 732-992-1896 Editorial Director Dalia Buffery dalia@engagehc.com 732-992-1889 Associate Editor Lara J. Lorton Editorial Assistant Jennifer Brandt jennifer@generaladminllc.com 732-992-1536 Production Manager Marie R. S. Borelli Sales Assistant Zach Ceretelle Quality Control Director Barbara Marino Business Manager Blanche Marchitto MISSION STATEMENT Oncology healthcare requires providers to focus attention on financial concerns and strategic decisions that affect the bottom line. To continue to provide the highquality care cancer patients deserve, providers must master the ever-changing business of oncology. Oncology Practice Management will offer process solutions for members of the cancer care team— medical, surgical, and radiation oncologists, 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.

FEATURES CASE STUDY The Role of Oncology Pharmacists in the Care Team: Chemotherapy Management and Supportive Care at St. Luke’s Mountain States Tumor Institute......................16

By Robert Mancini, PharmD

CANCER CENTER BUSINESS SUMMIT Compliance with Fair Market Value Critical to HospitalOncologist Alignments........................................................28 DRUG CODING Medications Used for the Treatment of Prostate Cancer..................................................................30 HEALTH POLICY The End of Health Insurance Companies......................34

By Ezekiel J. Emanuel and Jeffrey B. Liebman

DEPARTMENTS Patient and Provider Access Brought to you by the Association of Community Cancer Centers

Oral Parity: Taking It to the Next Level..................................29

By Sydney Abbott, JD

Physician Wealth Management With Lawrence B. Keller, CLU, ChFC, CFP®

Business Disability Insurance and Your Medical Practice......................................................................36

Oncology Practice Management™, ISSN 2164-4403(print), is published 4 times a year by Engage Healthcare Communications, LLC, 241 Forsgate Drive, Suite 205A, Monroe Township, NJ 08831. Copyright © 2012 by Engage Healthcare Communications, LLC. All rights reserved. Oncology Practice Management™ is a registered trademark of Engage Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the publisher. Printed in the United States of America.

The ideas and opinions expressed in Oncology 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 Oncology 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, Oncology Practice Management™, 241 Forsgate Drive, Suite 205A, Monroe Township, NJ 08831. Fax: 732-992-1881. Yearly subscription rates: 1 year: $99.00 USD; 2 years: $149.00 USD; 3 years: $199.00 USD.

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ONCOLOGY PRACTICE MANAGEMENT

I March 2012

THE AFINITOR® (everolimus) TABLETS $25 CO-PAY CARD FROM NOVARTIS PHARMACEUTICALS CORPORATION Designed to help make treatment more affordable for your eligible AFINITOR patients h The AFINITOR $25 Co-Pay Card Novartis offers eligible AFINITOR patients the $25 Co-Pay Card: an assistance program that allows commercial or cash-paying patients to pay a maximum of $25 for their AFINITOR prescription. Novartis will pay the balance of patients’ out-of-pocket expenses, up to a maximum of $1,200 per prescription.* The $25 Co-Pay Card is available at the physician’s office or online at www.AFINITOR.com.

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Helping make access to AFINITOR easier Novartis Oncology shares your commitment to helping patients living with cancer receive the medicines they need. Patient Assistance Now Oncology offers quick and easy access to information about the broad array of support and reimbursement programs available for patients.

For more information about AFINITOR access services, please visit www.AFINITOR.com.

* Not valid for prescriptions for which payment may be made in whole or in part under federal or state health care programs, including, but not limited to, Medicare, Medicaid, or for residents in Massachusetts. Additional limitations may apply.

This program is available for a limited time.

Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936

©2012 Novartis

Printed in USA

2/12

AFI-1036326

From the Editor

Where Are We Going?…Continued from page 3 actually delivered. Cancer drugs were not readily available from any other source, and specialized oncology distributors evolved to serve the growing cancer center market. In 1993, the federal government recognized that the physician codes and rates for oncology were inadequate and that the margin on the average wholesale price–based drug reimbursement model was covering the inadequacy, but the government decided not to change the situation because of the complexity of enacting such a change.

In 2003, the World Shifted Under Oncologists, Patients Just as some wins were being logged against cancer death rates, and care management and treatment allowed some cancers to become more chronic than fatal, 3 key aspects of the 2003 Medicare Modernization and Improvement Act (MMA) shifted the oncology care model.

First, reimbursements for oncology drugs paid to medical offices were reduced, and now based on an average sales price (ASP). Drug acquisition and inventory costs, even distributor mark-ups for sale to physicians, were not included in the ASP calculation. Despite a couple of years of temporary transitional adjustments, reimbursement rates and calculations for professional services related to oncology care also continued to decline on a net basis.

Margins were tightening and practices started to analyze drug costs and reimbursements for both themselves and the patients.

Second, Medicare Advantage plans were established that offered Part D drug benefits to Medicare patients. Initially, premiums, copays, and coinsurances were low and attractive to Medicare patients.

Gradually, third and higher tiers were created for specialty drugs, and oncol-

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ogy drugs tended to be placed on the highest tiers. This led to increased coinsurances and copays for patients with cancer, and started a chain of patient access to care issues and site of care shifts based upon patient insurance coverage. A majority of Medicaid and Medicare patients without supplemental insurance were likely to shift to the limited hospital outpatient center sites of service, driven by cost burdens for physicians and patients in the community setting.

Third, the Competitive Acquisition Program (CAP) generated attention on the prospect of a specialty pharmacy delivering drugs (in a practice known as “white bagging”) to an oncology practice and billing the payer directly, thus eliminating physician buy and bill. The CAP program was not successful or attractive to either specialty pharmacies or oncology physicians, and faded into limbo after its first years of existence. The program did, however, spark interest among specialty pharmacies about entering the oncology market for the first time.

Further Change and Interest from External Parties In 2009, a new wave of federal healthcare reform created incentives for hospital-employed physician models and accountable care organizations (ACOs) to evolve. Not only specialty pharmacies, but also a number of pharmacy benefit managers and other companies aggressively built programs and proposals for private health insurers to use in managing oncology drugs, treatment, and costs. Words and concepts such as pay-for-performance, guidelines and pathways, preferred treatment regimens, evidence-based payments, episode-based payments, and oncology medical homes became hot topics and buzz words for 2010, 2011, and into 2012. Hospitals became

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interested again in expanding their oncology services and started buying practices that felt financially vulnerable as a result of all of the changes since 2003.

How Will Cancer Care Evolve Now? Doctors will continue to treat patients. Drugs will be discovered and eventually approved by the FDA. All else appears to be up for grabs. There are at least 6 key variables that could shape what the cancer care delivery market will look like in 2022. Your decisions as an individual physician, administrator, and group may not change any of these by themselves, but should a sufficient volume of individual decisions all go in one direction or another, the tides could be shifted for those who do not take action.

Site of care. The federal government is encouraging consolidation between hospital organizations and private physician groups. In some states (ie, VT, RI, most of MA, and KY for now), there are few private oncology practices left; the rest have been integrated into hospital systems. Private health plans are concerned, because many feel that the rates they pay hospitals for services and drugs are higher than the rates paid to practices. Some plans are rapidly changing contractual terms for both practices and hospitals to address those inequalities. There can be advantages to more integrated systems: multidisciplinary care management, enhanced supportive services that are not billable in their own right, enhanced communications across a broad spectrum of departments, and enhanced accreditation and quality designations. There can be advantages to physician-based practices remaining separate but col-

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VELCADE and Millennium are registered trademarks of Millennium Pharmaceuticals, Inc. Other trademarks are property of their respective owners. *The VELCADE Reimbursement Assistance Program does not file claims or appeal claims for callers, nor can it guarantee that you will be successful in obtaining reimbursement

Millennium Pharmaceuticals, Inc., Cambridge, MA 02139 Copyright Š 2010, Millennium Pharmaceuticals, Inc. All rights reserved.

Printed in USA

V-10-0196

11/10

From the Editor

Where Are We Going?…Continued from page 6 laborative with integrated systems: streamlined delivery and cost-efficiencies, patient-focused care, enhanced software systems suited specifically for oncology, and physician-driven focus on quality and patient care. Size and business acumen coupled with technology advances will be essential for any practice seeking to remain independent.

Oncology management. Numerous private entities are building programs for sale to health plans and the federal government that address managing oncology care across all sites of care. The current diversity of care sites in oncology and the silos in which care is delivered can become a liability to those who pay for the cancer care, because of limitations on their ability to collaborate with or influence all of the moving parts of the care process. Even if the oncology management focuses solely on the approval, claims processing, and possibly delivery of drugs, there may be interest by health plans on such solutions if they can be applied universally across all care providers. The more volatile the financial stability of the oncology providers in a market, the more likely that programs of this nature may be considered by health plans and the private entities.

Once an oncology management program is established in an individual health plan, the harder it will be for either hospitals or independent practices to negotiate exceptions.

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Evidence-based care, guidelines, and pathways. Successful health reform in oncology will be driven by data we do not currently have. We cannot track the variation in care across groups, hospitals, and practices today in a way that relates to a consistent national standard or to help us prove existing treatment standards of care. At best, some groups in some

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regions have started the process. In the near future, we will either come together on a single or limited number of platforms we find clinically acceptable in the oncology community, or the decision of which platforms are used will be made outside of the oncology community. We want to let evidence support decisions, but to get evidence we have to share data. Hospitals, private practices, and patients will need to become comfortable quickly with the concept of collectively assessing chosen treatments for state and stage of patients, and then combining that clinically enhanced data with health plan claims data that brings in total cost of care for those patients. If we do not, health plans will develop (some already have started) their own extrapolated cancer data and use that for future oncology coverage policy.

Medical homes and ACOs. Hospitals and primary care organizations across the country are exploring ACO options. Oncology is not yet part of that discussion and is not even addressed in the initial Medicare descriptions of ACOs. What oncology practices do in 2012 will likely set the stage for future negotiating power in their markets once these new structures, however they evolve, become established.

Numerous pilots exploring the concept of an oncology patient–centered medical home are in play already across the country (eg, in CA, MA, MI, NM, and PA), but these are complex processes that require a significant level of sophistication both on the part of the practice and any participating health plans. One worry is that practices that wait and watch will find themselves unable to catch up fast enough and will be caught up in the tide of whatever becomes the prevalent model for their geography. The old

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adage, “It takes money to make money” could be modified in this situation to, “You can’t win if you don’t play, and it will take money and technology and commitment to play.” We do not know exactly what model will survive into the year 2022, but we do know we will be using technology to track and move patient care through more detailed and consistent processes than have ever been envisioned in the past.

Access to care. Some pundits have reported that Medicaid enrollment may exceed Medicare enrollment in the next few years as health insurance exchanges evolve, if they do. Should that happen, and reimbursement levels for large numbers of patients shift from commercial plans to these exchanges, that alone could drive all independent care providers to join a system—and there is little that any one innovative group or health plan could do to stem that tide. Shifting medical care and reimbursement rates to one level, particularly if it is a lower level comparable to current Medicaid rates, could become devastating to the war we have recently fought with cancer. Lowest common denominator care pricing could adversely affect access to, and private patients’ selection of treatment regimens with newer, perhaps more costly drugs. Medicaid drug formularies for the most part appear to be heavily influenced by net prices and rebates and far less by conventional medical practice or clinical decisions. Ultimately innovation in oncology care may become stifled, or drugs and medical care may become more distinctly tiered than today. One would hope that this will not be a likely scenario, but as of now, it is in the realm of possibilities.

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From the Editor

American College of Oncology Administrators

Professionals dedicated to providing the best care to oncology patients. Here’s where you belong.

Transform Your Leadership Work Smarter Access Solutions Make Key Contacts Strengthen Your Skills

Annual Oncology Conference Addresses Oncology Management Strategies Chicago, June 20 – 22, 2012 Developed by and for oncology administrators with networking and exhibiting opportunities

Ensure Your Connections. Join Now. www.aameda.org • membership@aameda.org AAMA/ACOA • 701 Lee St., Suite 600 • Des Plaines, IL 60016 • Phone 847-759-8601 • Fax 847-759-8602 ACOA is a national College of the American Academy of Medical Administrators (AAMA)

Where Are We Going?…Continued from page 8 Specialty pharmacy, pharmacy benefit management, and oncology. There is a strong interest and drive for health plans, specialty pharmacies, and pharmacy benefit managers to define a management role in oncology, through interactions with health plans and employers, more than physicians and hospitals.

Although most hospitals now utilize their own pharmacies, oncology care is still billed under the medical benefit. The medical benefit is under intense scrutiny as to whether a complex and costly disease such as cancer can be best tracked through that process, or if an alternative structure, such as the pharmacy benefit (which is not traditionally billed by physicians), would be preferable. Physi-

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cians in independent practice tend to be more vocal about such changes and engaged in discussions with health plans and employers about the viability of those and other alternatives. Physicians employed by hospitals may tend to be less engaged, which could be an asset or a problem for both the other physicians in the community and the health plans seeking to address oncology issues.

Specialty pharmacies seeking to enter the oncology market may find increasing numbers of markets controlled by hospital systems, which tend to utilize their own pharmacies.

trol? The year 2012 is a landmark year. There are more opportunities than ever to collaborate, engage, track, evaluate, and move the discussion of oncology management forward in a positive way for patients, physicians, hospital systems, health plans, and employers.

Knowing what is riding the wave coming our way is the first step.

Deciding to push forward into the current and start paddling is the second step. Enlarging your platform and adding tools to assist you navigate the turbulent waters is the next. Hopefully, when this is over, you’ll be one of the groups that has ridden the wave all the way into the next decade and will be proudly fighting cancer with your patients for another decade. l

Where are you going? Will you lead the way or be swept along by forces seemingly beyond your con-

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Technology 2.0

Going Electronic…Continued from the cover worldwide, have online bill pay and account access, yet we are satisfied operating with paper charts from practice to practice, with no electronic connectivity—dinosaurs in a modern world.

Before and after that speech, I have attended many talks and listened to early adopters of EMRs, which morphed into electronic health records (EHRs) during this extended time span.

So, why was our group so slow to move into this exciting technology?

Most of our 9 physicians were satisfied with paper charts. To me, jumping in seemed expensive in more ways than one. Not only was the actual cost high with an exorbitant time commitment, companies were going into business with a splash but were then bought or were out of business a few years later. Then there were the anecdotal stories that persisted of a necessary employment change after leading a less-thanideal EHR implementation.

No matter what your politics, I believe the game change came with the American Recovery and Reinvestment Act of 2009. Significant monies became available to eligible professionals to help fund the cost of an EHR and with this, the hammer of a Medicare penalty if you did not adopt a certified, meaningfully used EHR by 2015. I saw that this was the time to push us forward and pursue an EHR. In early 2010, I presented 2 oncology-specific “cloud” EHRs to our physicians to choose from. The upfront cost for these choices was significantly less than EHRs housed on-site, with practice-owned hardware. This also enabled us to keep our current server room intact without additional space requirements.

Updates would be done automatically in the cloud during off hours, with no interruption to the practice.

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Again, learning from others who had already implemented an EHR and shared their wisdom, I chose an oncology-specific system, knowing, among other things, that the regimen library would already be built for most protocols and be updated as new drugs entered the market.

This would be a huge time-saver. In the end, our physicians opted for the iKnowMed EHR offered by McKesson.

We use our credit and debit cards everywhere in this country or worldwide, have online bill pay and account access, yet we are satisfied operating with paper charts from practice to practice, with no electronic connectivity— dinosaurs in a modern world.

—Ruth Linné Lander, FACMPE

With the decision made and the contract signed, time moved along as we went through biweekly phone implementation planning meetings and made necessary decisions along the way as we neared a go-live date in January 2012. I was hopeful, yet skeptical, that only a 2-week reduced schedule was indeed needed with this program. I had heard and read so many times to plan on 6 months or

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up to a year of lost productivity. But we were assured it would be better than that.

We are 6 weeks past our go-live date, and physician-patient productivity was in fact down only a few weeks. As with all new systems, physicians spend extra hours loading patient information for first visits in the EHRs, but that will end in time.

I walked around the office yesterday and did not see “train wrecks” in the various departments but rather smiles. Our staff is still learning, but they like the chosen product and see many benefits versus our paper-only days already. The benefits we are seeing now, or will see in the near future, are:

Efficiency Legibility. A huge benefit already enjoyed by most of our staff, instead of stopping to ask questions about what was written, the information is clearly presented, which impacts questions about prescriptions or physician and scheduling orders.

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The hunt for charts is over. This is self-evident.

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Concurrent record use. Physicians, nursing, medical records, scheduling, or other staff can all be in the same patient chart doing various tasks concurrently. This is an incredible efficiency benefit.

Physician access 24/7 from home and the hospital. A physician can check patient information, look at his or her queue, sign off on laboratories or other tests, and dictate and write orders from a convenient location outside of the office.

This is a major improvement from paper charts confined within a facility or removed from the facility.

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Continued on page 11

Technology 2.0

Improved use of staff time. With paper charts, nurses and other staff were often standing outside an examination room waiting to ask a physician about a patient for treatment, triage, scheduling, or billing issues. With the queue system built into the EHR, staff no longer need to waste precious time in the hall.

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Patient portal. We will be going on the newly available patient portal as soon as possible. Not only will this help us with some meaningful-use criteria, but again it will save staff time (eg, calling patients with normal results).

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Portability of records. Electronically sending encrypted patient information across town or across the country is another positive EHR benefit. This saves faxing chart records or copying and mailing this information to patients being referred for other medical treatment or for the treatment of mobile patients spending parts of the year outside the area.

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Future area health information exchange (HIE). We are working with several larger groups and are hopeful that HIE will be up and running in central Ohio within the next few years to exchange patient data, thus avoiding test duplication and many other safety or cost-saving benefits to the patient and, ultimately, for total healthcare costs.

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Safety Privacy of patient records. Paper records can be stolen, misplaced, looked at by improper staff, or gone altogether as a result of a natural disaster. EHRs are only accessible

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by staff at specific and appropriate levels.

faxing letters and notes to our referring physicians.

Offsite backups of records prevent the likelihood of a total destruction of irreplaceable patient information.

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Staff time. Interfaces in place, or soon to be in place, bring all laboratories and key hospital testing directly into the patient’s electronic chart with a queue message for the physician to sign off on the new information. This saves significant amounts of staff time putting paper results on the physician desk and later picking up and filing the signed-off result.

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Patient drug interactions are flagged. A good electronic system will flag drug interactions, saving the patient a potential medical problem.

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Supplies. With the EHR, we do not have paper laboratories or key hospital information coming by fax or mail. In fact, paper use is down, a dollar savings to the practice and of trees for the environment.

Equipment toners and general wear are also reduced.

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I met with our medical protective malpractice agent recently, and I found that we will get a 2.5% credit off of each physician’s premium next year and in future years, because we have this certified technology.

Data mining made easy. We can run reports by diagnosis, drugs, age, or almost any data for use by the physicians as they research and continue to seek improvements in patient care.

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Moving Forward Finally, I am happy that we are on this side of our go-live date. It has been a positive experience, with only minimal bumps along the way. I met with our medical protective malpractice agent recently, and I found that we will get a 2.5% credit off of each physician’s premium next year and in future years, because we have this certified technology. It took us a long time to have an EHR, but it certainly was the right step for us as a medical practice in the twenty-first century. l

—Ruth Linné Lander, FACMPE

Monetary Savings Transcription. Dragon’s medical transcription oncology module is being used by all of our physicians since our go-live date. This is saving our group more than $125,000 in annual outside transcription costs.

We kept our 1 internal transcriptionist who edits as needed and continues our practice of electronically

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NOW APPROVED FOR SUBCUTANEOUS ADMINISTRATION

Subcutaneous VELCADE Demonstrated Efficacy Consistent With IV for the Primary Endpoint RESPONSE RATES† IN RELAPSED MULTIPLE MYELOMA (MM): SUBCUTANEOUS AND IV AT 12 WEEKS (AFTER 4 CYCLES) Single-agent VELCADE® (bortezomib)

AT 24 WEEKS (AFTER 8 CYCLES) VELCADE±dexamethasone

53% 51%

43% 42%

11% 12%

7% 8% ORR Primary Endpoint

CR

SC (n=148) IV (n=74)

ORR

CR

▼ The study met its primary non-inferiority objective that single-agent subcutaneous VELCADE retained at least 60% of the overall response rate after 4 cycles relative to single-agent IV VELCADE SUBCUTANEOUS VS IV TRIAL: a non-inferiority, phase 3, randomized (2:1), open-label trial compared the efficacy and safety of VELCADE administered subcutaneously (n=148) with VELCADE administered intravenously (n=74) in patients with relapsed MM. The primary endpoint was overall response rate at 4 cycles. Secondary endpoints included response rate at 8 cycles, median TTP and PFS (months), 1-year overall survival (OS), and safety. *INDICATIONS: VELCADE is indicated for the treatment of patients with multiple myeloma. VELCADE is indicated for the treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy. †

Responses were based on criteria established by the European Group for Blood and Marrow Transplantation.1

VELCADE IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol. VELCADE is contraindicated for intrathecal administration.

WARNINGS, PRECAUTIONS AND DRUG INTERACTIONS ▼ Peripheral neuropathy, including severe cases, may occur – manage with dose modification or discontinuation. Patients with preexisting severe neuropathy should be treated with VELCADE only after careful risk-benefit assessment ▼ Hypotension can occur. Use caution when treating patients receiving antihypertensives, those with a history of syncope, and those who are dehydrated ▼ Closely monitor patients with risk factors for, or existing heart disease ▼ Acute diffuse infiltrative pulmonary disease has been reported ▼ Nausea, diarrhea, constipation, and vomiting have occurred and may require use of antiemetic and antidiarrheal medications or fluid replacement ▼ Thrombocytopenia or neutropenia can occur; complete blood counts should be regularly monitored throughout treatment ▼ Tumor Lysis Syndrome, Reversible Posterior Leukoencephalopathy Syndrome, and Acute Hepatic Failure have been reported

IN ALL INDICATIONS*

Difference in Incidence of Peripheral Neuropathy With Subcutaneous VELCADE PERIPHERAL NEUROPATHY (PN) IN RELAPSED MM: SUBCUTANEOUS AND IV GRADE ≥3

6%

SC (n=147) IV (n=74)

16% ALL GRADES

38% 53% ▼ Starting VELCADE® (bortezomib) subcutaneously may be considered for patients with preexisting PN or patients at high risk for PN. Patients with preexisting severe neuropathy should be treated with VELCADE only after careful risk-benefit assessment ▼ Treatment with VELCADE may cause PN that is predominantly sensory. However, cases of severe sensory and motor PN have been reported. Patients should be monitored for symptoms of neuropathy, such as a burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, neuropathic pain, or weakness ▼ Patients experiencing new or worsening PN during therapy with VELCADE may require a decrease in the dose, a less-dose-intense schedule, or discontinuation. Please see full Prescribing Information for dose modification guidelines for PN

WARNINGS, PRECAUTIONS AND DRUG INTERACTIONS CONTINUED ▼ Women should avoid becoming pregnant while being treated with VELCADE. Pregnant women should be apprised of the potential harm to the fetus ▼ Closely monitor patients receiving VELCADE in combination with strong CYP3A4 inhibitors. Concomitant use of strong CYP3A4 inducers is not recommended

ADVERSE REACTIONS Most commonly reported adverse reactions (incidence ≥30%) in clinical studies include asthenic conditions, diarrhea, nausea, constipation, peripheral neuropathy, vomiting, pyrexia, thrombocytopenia, psychiatric disorders, anorexia and decreased appetite, neutropenia, neuralgia, leukopenia, and anemia. Other adverse reactions, including serious adverse reactions, have been reported

Please see Brief Summary for VELCADE on next page.

For Patient Assistance Information or Reimbursement Assistance, call 1-866-VELCADE (835-2233), Option 2, or visit VELCADEHCP.com Reference: 1. Moreau P, Pylypenko H, Grosicki S, et al. Subcutaneous versus intravenous administration of bortezomib in patients with relapsed multiple myeloma: a randomised, phase 3, non-inferiority study. Lancet Oncol. 2011;12(5):431-440.

Brief Summary INDICATIONS: VELCADE® (bortezomib) for Injection is indicated for the treatment of patients with multiple myeloma. VELCADE® (bortezomib) for Injection is indicated for the treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy.

CONTRAINDICATIONS: VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol. VELCADE is contraindicated for intrathecal administration.

WARNINGS AND PRECAUTIONS: VELCADE should be administered under the supervision of a physician experienced in the use of antineoplastic therapy. Complete blood counts (CBC) should be monitored frequently during treatment with VELCADE. Peripheral Neuropathy: VELCADE treatment causes a peripheral neuropathy that is predominantly sensory. However, cases of severe sensory and motor peripheral neuropathy have been reported. Patients with pre-existing symptoms (numbness, pain or a burning feeling in the feet or hands) and/or signs of peripheral neuropathy may experience worsening peripheral neuropathy (including ≥ Grade 3) during treatment with VELCADE. Patients should be monitored for symptoms of neuropathy, such as a burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, neuropathic pain or weakness. In the Phase 3 relapsed multiple myeloma trial comparing VELCADE subcutaneous vs. intravenous the incidence of Grade ≥ 2 peripheral neuropathy events was 24% for subcutaneous and 41% for intravenous. Grade ≥ 3 peripheral neuropathy occurred in 6% of patients in the subcutaneous treatment group, compared with 16% in the intravenous treatment group. Starting VELCADE subcutaneously may be considered for patients with pre-existing or at high risk of peripheral neuropathy.

Patients experiencing new or worsening peripheral neuropathy during VELCADE therapy may benefit from a decrease in the dose and/or a less dose-intense schedule. In the single agent phase 3 relapsed multiple myeloma study of VELCADE vs. Dexamethasone following dose adjustments, improvement in or resolution of peripheral neuropathy was reported in 51% of patients with ≥ Grade 2 peripheral neuropathy in the relapsed multiple myeloma study. Improvement in or resolution of peripheral neuropathy was reported in 73% of patients who discontinued due to Grade 2 neuropathy or who had ≥ Grade 3 peripheral neuropathy in the phase 2 multiple myeloma studies. The long-term outcome of peripheral neuropathy has not been studied in mantle cell lymphoma.

Hypotension: The incidence of hypotension (postural, orthostatic, and hypotension NOS) was 13%. These events are observed throughout therapy. Caution should be used when treating patients with a history of syncope, patients receiving medications known to be associated with hypotension, and patients who are dehydrated. Management of orthostatic/ postural hypotension may include adjustment of antihypertensive medications, hydration, and administration of mineralocorticoids and/or sympathomimetics.

Cardiac Disorders: Acute development or exacerbation of congestive heart failure and new onset of decreased left ventricular ejection fraction have been reported, including reports in patients with no risk factors for decreased left ventricular ejection fraction. Patients with risk factors for, or existing heart disease should be closely monitored. In the relapsed multiple myeloma study of VELCADE vs. dexamethasone, the incidence of any treatment-emergent cardiac disorder was 15% and 13% in the VELCADE and dexamethasone groups, respectively. The incidence of heart failure events (acute pulmonary edema, cardiac failure, congestive cardiac failure, cardiogenic shock, pulmonary edema) was similar in the VELCADE and dexamethasone groups, 5% and 4%, respectively. There have been

isolated cases of QT-interval prolongation in clinical studies; causality has not been established.

Pulmonary Disorders: There have been reports of acute diffuse infiltrative pulmonary disease of unknown etiology such as pneumonitis, interstitial pneumonia, lung infiltration and Acute Respiratory Distress Syndrome (ARDS) in patients receiving VELCADE. Some of these events have been fatal. In a clinical trial, the first two patients given high-dose cytarabine (2 g/m2 per day) by continuous infusion with daunorubicin and VELCADE for relapsed acute myelogenous leukemia died of ARDS early in the course of therapy. There have been reports of pulmonary hypertension associated with VELCADE administration in the absence of left heart failure or significant pulmonary disease. In the event of new or worsening cardiopulmonary symptoms, a prompt comprehensive diagnostic evaluation should be conducted.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): There have been reports of RPLS in patients receiving VELCADE. RPLS is a rare, reversible, neurological disorder which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances. Brain imaging, preferably MRI (Magnetic Resonance Imaging), is used to confirm the diagnosis. In patients developing RPLS, discontinue VELCADE. The safety of reinitiating VELCADE therapy in patients previously experiencing RPLS is not known.

Gastrointestinal Adverse Events: VELCADE treatment can cause nausea, diarrhea, constipation, and vomiting sometimes requiring use of antiemetic and antidiarrheal medications. Ileus can occur. Fluid and electrolyte replacement should be administered to prevent dehydration.

Thrombocytopenia/Neutropenia: VELCADE is associated with thrombocytopenia and neutropenia that follow a cyclical pattern with nadirs occurring following the last dose of each cycle and typically recovering prior to initiation of the subsequent cycle. The cyclical pattern of platelet and neutrophil decreases and recovery remained consistent over the 8 cycles of twice weekly dosing, and there was no evidence of cumulative thrombocytopenia or neutropenia. The mean platelet count nadir measured was approximately 40% of baseline. The severity of thrombocytopenia was related to pretreatment platelet count. In the relapsed multiple myeloma study of VELCADE vs. dexamethasone, the incidence of significant bleeding events (≥Grade 3) was similar on both the VELCADE (4%) and dexamethasone (5%) arms. Platelet counts should be monitored prior to each dose of VELCADE. Patients experiencing thrombocytopenia may require change in the dose and schedule of VELCADE. There have been reports of gastrointestinal and intracerebral hemorrhage in association with VELCADE. Transfusions may be considered. The incidence of febrile neutropenia was <1%.

Tumor Lysis Syndrome: Because VELCADE is a cytotoxic agent and can rapidly kill malignant cells, the complications of tumor lysis syndrome may occur. Patients at risk of tumor lysis syndrome are those with high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken.

Hepatic Events: Cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions. Other reported hepatic events include increases in liver enzymes, hyperbilirubinemia, and hepatitis. Such changes may be reversible upon discontinuation of VELCADE. There is limited re-challenge information in these patients.

Hepatic Impairment: Bortezomib is metabolized by liver enzymes.

Bortezomib exposure is increased in patients with moderate or severe hepatic impairment; these patients should be treated with VELCADE at reduced starting doses and closely monitored for toxicities. (continued)

Use in Pregnancy: Pregnancy Category D. Women of childbearing potential should avoid becoming pregnant while being treated with VELCADE (bortezomib). Bortezomib administered to rabbits during organogenesis at a dose approximately 0.5 times the clinical dose of 1.3 mg/m2 based on body surface area caused post-implantation loss and a decreased number of live fetuses.

ADVERSE EVENT DATA: Safety data from phase 2 and 3 studies of single-agent VELCADE 1.3 mg/m2/dose administered intravenously twice weekly for 2 weeks followed by a 10-day rest period in 1163 patients with previously treated multiple myeloma (N=1008, not including the phase 3, VELCADE plus DOXIL® [doxorubicin HCI liposome injection] study) and previously treated mantle cell lymphoma (N=155) were integrated and tabulated. In these studies, the safety profile of VELCADE was similar in patients with multiple myeloma and mantle cell lymphoma.

In the integrated analysis, the most commonly reported adverse events were asthenic conditions (including fatigue, malaise, and weakness); (64%), nausea (55%), diarrhea (52%), constipation (41%), peripheral neuropathy NEC (including peripheral sensory neuropathy and peripheral neuropathy aggravated); (39%), thrombocytopenia and appetite decreased (including anorexia); (each 36%), pyrexia (34%), vomiting (33%), anemia (29%), edema (23%), headache, paresthesia and dysesthesia (each 22%), dyspnea (21%), cough and insomnia (each 20%), rash (18%), arthralgia (17%), neutropenia and dizziness (excluding vertigo); (each 17%), pain in limb and abdominal pain (each 15%), bone pain (14%), back pain and hypotension (each 13%), herpes zoster, nasopharyngitis, upper respiratory tract infection, myalgia and pneumonia (each 12%), muscle cramps (11%), and dehydration and anxiety (each 10%). Twenty percent (20%) of patients experienced at least 1 episode of ≥Grade 4 toxicity, most commonly thrombocytopenia (5%) and neutropenia (3%). A total of 50% of patients experienced serious adverse events (SAEs) during the studies.

The most commonly reported SAEs included pneumonia (7%), pyrexia (6%), diarrhea (5%), vomiting (4%), and nausea, dehydration, dyspnea and thrombocytopenia (each 3%).

In the phase 3 VELCADE + melphalan and prednisone study in previously untreated multiple myeloma, the safety profile of VELCADE administered intravenously in combination with melphalan/prednisone is consistent with the known safety profiles of both VELCADE and melphalan/ prednisone. The most commonly reported adverse events in this study (VELCADE+melphalan/prednisone vs melphalan/prednisone) were thrombocytopenia (52% vs 47%), neutropenia (49% vs 46%), nausea (48% vs 28%), peripheral neuropathy (47% vs 5%), diarrhea (46% vs 17%), anemia (43% vs 55%), constipation (37% vs 16%), neuralgia (36% vs 1%), leukopenia (33% vs 30%), vomiting (33% vs 16%), pyrexia (29% vs 19%), fatigue (29% vs 26%), lymphopenia (24% vs 17%), anorexia (23% vs 10%), asthenia (21% vs 18%), cough (21% vs 13%), insomnia (20% vs 13%), edema peripheral (20% vs 10%), rash (19% vs 7%), back pain (17% vs 18%), pneumonia (16% vs 11%), dizziness (16% vs 11%), dyspnea (15% vs 13%), headache (14% vs 10%), pain in extremity (14% vs 9%), abdominal pain (14% vs 7%), paresthesia (13% vs 4%), herpes zoster (13% vs 4%), bronchitis (13% vs 8%), hypokalemia (13% vs 7%), hypertension (13% vs 7%), abdominal pain upper (12% vs 9%), hypotension (12% vs 3%), dyspepsia (11% vs 7%), nasopharyngitis (11% vs 8%), bone pain (11% vs 10%), arthralgia (11% vs 15%) and pruritus (10% vs 5%).

In the phase 3 VELCADE subcutaneous vs. intravenous study in relapsed multiple myeloma, safety data were similar between the two treatment groups. The most commonly reported adverse events in this study were peripheral neuropathy NEC (38% vs 53%), anemia (36% vs 35%), thrombocytopenia (35% vs 36%), neutropenia (29% vs 27%), diarrhea (24% vs 36%), neuralgia (24% vs 23%), leukopenia (20% vs 22%), pyrexia (19% vs 16%), nausea (18% vs 19%), asthenia (16% vs 19%), weight decreased (15% vs 3%), constipation (14% vs 15%), back pain (14% vs 11%), fatigue (12% vs 20%), vomiting (12% vs 16%), insomnia (12% vs 11%), herpes zoster (11% vs 9%), decreased appetite (10% vs 9%), hypertension (10% vs 4%), dyspnea (7% vs 12%), pain in extremities (5% vs 11%), abdominal pain and headache (each 3% vs 11%), abdominal pain upper (2% vs 11%). The incidence of serious adverse events was similar for the subcutaneous treatment group (36%) and the intravenous treatment group (35%). The most commonly reported SAEs

were pneumonia (6%) and pyrexia (3%) in the subcutaneous treatment group and pneumonia (7%), diarrhea (4%), peripheral sensory neuropathy (3%) and renal failure (3%) in the intravenous treatment group.

DRUG INTERACTIONS: Bortezomib is a substrate of cytochrome P450 enzyme 3A4, 2C19 and 1A2.

Co-administration of ketoconazole, a strong CYP3A4 inhibitor, increased the exposure of bortezomib by 35% in 12 patients. Therefore, patients should be closely monitored when given bortezomib in combination with strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir). Co-administration of omeprazole, a strong inhibitor of CYP2C19, had no effect on the exposure of bortezomib in 17 patients. Co-administration of rifampin, a strong CYP3A4 inducer, is expected to decrease the exposure of bortezomib by at least 45%. Because the drug interaction study (n=6) was not designed to exert the maximum effect of rifampin on bortezomib PK, decreases greater than 45% may occur. Efficacy may be reduced when VELCADE (bortezomib) is used in combination with strong CYP3A4 inducers; therefore, concomitant use of strong CYP3A4 inducers is not recommended in patients receiving VELCADE. St. John’s Wort (Hypericum perforatum) may decrease bortezomib exposure unpredictably and should be avoided. Co-administration of dexamethasone, a weak CYP3A4 inducer, had no effect on the exposure of bortezomib in 7 patients.

Co-administration of melphalan-prednisone increased the exposure of bortezomib by 17% in 21 patients. However, this increase is unlikely to be clinically relevant.

USE IN SPECIFIC POPULATIONS: Nursing Mothers: It is not known whether bortezomib 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 VELCADE, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: The safety and effectiveness of VELCADE in children has not been established.

Geriatric Use: No overall differences in safety or effectiveness were observed between patients ≥age 65 and younger patients receiving VELCADE; but greater sensitivity of some older individuals cannot be ruled out.

Patients with Renal Impairment: The pharmacokinetics of VELCADE are not influenced by the degree of renal impairment. Therefore, dosing adjustments of VELCADE are not necessary for patients with renal insufficiency. Since dialysis may reduce VELCADE concentrations, VELCADE should be administered after the dialysis procedure. For information concerning dosing of melphalan in patients with renal impairment, see manufacturer’s prescribing information.

Patients with Hepatic Impairment: The exposure of bortezomib is increased in patients with moderate and severe hepatic impairment.

Starting dose should be reduced in those patients.

Patients with Diabetes: During clinical trials, hypoglycemia and hyperglycemia were reported in diabetic patients receiving oral hypoglycemics. Patients on oral antidiabetic agents receiving VELCADE treatment may require close monitoring of their blood glucose levels and adjustment of the dose of their antidiabetic medication.

Please see full Prescribing Information for VELCADE at VELCADEHCP.com.

VELCADE, MILLENNIUM and are registered trademarks of Millennium Pharmaceuticals, Inc. Other trademarks are property of their respective owners.

Millennium Pharmaceuticals, Inc., Cambridge, MA 02139 Copyright © 2012, Millennium Pharmaceuticals, Inc. All rights reserved.

Printed in USA

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Case Study

The Role of Oncology Pharmacists in the Care Team: Chemotherapy Management and Supportive Care at St. Luke’s Mountain States Tumor Institute

By Robert Mancini, PharmD Dr Mancini is an Oncology Pharmacist, and Chair of the Pain Comfort Committee, St. Luke’s Mountain States Tumor Institute, Boise, ID

T

he purpose of this article is to outline the benefits that pharmacists can play in cancer care. Each discipline within the interdisciplinary cancer team has people trained in a specific area of expertise.

With the amount of information, the number of drugs, and the many changes taking place in oncology these days, the pharmacist is the expert best trained in the medications themselves. Physicians are aware of what constitutes the best regimens for the specific pathology, but when it comes to counseling patients on medications, including intravenous and to oral medications, and helping with any side effects management, pharmacists can provide a lot of benefit in practice. This also includes helping the nononcology clinical disciplines understand any issues of additional medications that the patient with cancer may be taking for comorbidities.

At our cancer institute at St. Luke’s, when our physicians have questions about medications—such as dose adjustment for renal or liver functions or dosing based on other medications or drug interactions— the pharmacist is the one who can answer those questions. Physicians at cancer practices should be encouraged to call the pharmacist, who may

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not be present at the clinic but may be at the infusion center or down the hall in the pharmacy; a simple phone call and a quick conversation with the pharmacist may promptly resolve any dosing-related questions or concerns.

Infusion Therapy/Antiemetic Medication Protocol The role of the pharmacist in infusion therapy likely varies by institution. At St. Luke’s, the pharmacist is responsible for the process once the physician orders infusion treatment for the patient. When we get the orders for the chemotherapy, it is the pharmacist’s role to evaluate that it is the right drug for the right indication, and that any other medications that the patient is taking will not interact with or interfere with the chemotherapy. The pharmacist double-checks the laboratory results to make sure that that particular chemotherapy is appropriate for that patient’s blood count, and that the dose is appropriate if the patient has renal or hepatic dysfunction.

Our role is to check that we are preparing the medication correctly, that the dose is correct, that it is what the patient gets, and it matches what the physician ordered.

According to our antiemetic protocol, the pharmacists are the ones who help to determine what antinausea medications are given to the patient before chemotherapy, and any other premedications for a par-

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ticular type of chemotherapy, as well as ensuring that the patient gets those medications.

Individual protocols vary from center to center. At St. Luke’s, our protocol is based on a combination of guidelines. One of our pharmacists evaluated the National Comprehensive Cancer Network (NCCN), the American Society of Clinical Oncology, and Multinational Association of Supportive Care in Cancer guidelines to determine what protocol we would use. The goal was to evaluate the emetogenic potential of chemotherapy, and to see how that translates into what medications we should be giving the patient.

Although this may differ from state to state, the pharmacists ultimately need to follow the protocol, while taking into account any patient-specific abnormalities or changes and apply them to the center’s protocol.

Our protocol is standardized: if the emetogenic potential is this, then these are the medications we have to give. But there are situations within the protocol that say, “Under these circumstances, you can add this medication. Under those circumstances, you can take away this medication.” If it is necessary to seriously deviate from the protocol, we discuss this with the physician and make sure that we are on the same page before we move forward with that different approach.

This further highlights the value Continued on page 18

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With continual communication and consistent follow-through, your dedicated Celgene Patient Support® Specialist will streamline access to Celgene products by helping you and your patients with: t Benefits investigation

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Visit: www.CelgenePatientSupport.com Monday through Friday, 8:00 AM to 7:00 PM ET

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4 out of 5 patients who requested assistance from Celgene Patient Support ® received their medication.

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Case Study

The Role of Oncology Pharmacist…Continued from page 16 of the interdisciplinary team, these steps are in place to help foster the interaction between the various disciplines. Our infusion center is just down the hall from where the physicians are seeing their patients. It is therefore very easy for us, the pharmacists, to walk over and chat with the physicians, or vice versa; physicians and mid-level personnel often come to the pharmacy to ask questions related to patients, symptoms, or medication side effects, such as “The patient is having this symptom. What do you think about adding in this medication?”

Our physicians see approximately 20 patients daily, so they are very busy. Sometimes, when the laboratory results are not yet available, they rely on us to double-check the results when they arrive and talk to them if there is something abnormal.

If the blood count comes back abnormal, we check with them to and see what they want to do. It may involve dose reduction or postponing the chemotherapy.

Oral Chemotherapy Program In our oral chemotherapy program (see December 2011 issue), we have been able to vastly improve patient access to medications, as well as the understanding of medications. St. Luke’s has a unique oral chemotherapy program that includes a full-time pharmacist who is dealing only with oral chemotherapy; this is unique in the way the program is set up, in the way the pharmacist interacts with the physicians, the nurses, the social workers, our financial advocates, and the whole system.

It has taken us a couple of years to work out this program, but the result is very beneficial for our patients, as well as for the healthcare system as a whole. We may not be the only center that is involving pharmacists in

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the oral chemotherapy program in this way, but our actual process and this particular setup may be different.

The oral chemotherapy program is managed by a pharmacist. When the physician and the patient decide to start on an oral chemotherapy agent, the prescription is sent to our central pharmacy in Boise, ID. In Boise, we have oncology-trained pharmacists who are running the office, where all the oral chemotherapy agents are received. Once the patient has received the prescription and has actually received the medication, the pharmacist makes sure to follow up with the patient on a weekly basis during their first chemotherapy cycle.

We have a scheduled weekly call to the patient to ensure that everything is going well, to see how the patient is doing, and whether the patient had any problems taking the medication, or if the patient is having any side effects or other things of that nature.

Managing Drug Costs One of the things that we all face with cancer medications is high cost.

On average, these medications range from a couple of hundreds of dollars monthly for cheaper generics, such as oral cyclophosphamide, and up to $10,000 monthly or more for some of the newer oral agents. That can be a major issue, especially for patients who may be taking such agents until their disease progresses. Spending $10,000 a month for up to 2, 3, or 4 years, or longer in the case of some of patients with chronic myeloid leukemia, is very costly.

That is a serious burden for the center, as well as for the patient and the healthcare system. For patients, depending on their insurance, some of these medications can be covered

by Medicare Part B or their major medical plan. However, in many cases, they are still responsible for up to 20% of the drug, and 20% of

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$10,000 is still $2000.

The other issue is patients who go through their prescription drug benefits, such as Medicare Part D, do not necessarily have a supplement to help them get through the donut hole. In many of these cases, their first fill is going to skyrocket them through that donut hole, and they are going to be responsible for up to $5000 of that first fill. After that they will only be responsible for approximately 5% based on their Part D plan. But if we cannot get them through the first fill, they are not going to make it to their second or third one.

We try to find ways to help with cost by assisting with prior authorizations and through our financial advocates at Mountain States Tumor Institute. They are familiar with the programs for free drugs, copay assistance, and other programs that can help patients afford these medications. We recently conducted an evaluation that showed that only approximately 1% of our patients do not receive their medications because of insurance or cost issues.

Therefore, we have been able to help greatly reduce nonfulfillment rates, compared with the 10% to 20% reported in the literature.

Supportive/Palliative Care Clinics Another unique feature at our center is the involvement of the pharmacists in the multidisciplinary supportive care clinic or palliative care clinic. We have been able to do this thanks to a grant we received through our National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP). This program helps to provide a unique benefit to patients, by allowing us to bridge the gap between patients who may not get to see a pharmacist and those who now are getting a full

Case Study

work-up and a full medication reconciliation, with the pharmacist through this program.

The supportive/palliative care clinics at St. Lukeâ&#x20AC;&#x2122;s are a part of the NCCCP. Within this NCI program, we have been able to hire a parttime pharmacist to help with these clinics. Having a pharmacist who can sit down with these more complex patients and do full medication reconciliation greatly improves cancer care for our patients. This program has enabled us to find many places for improvement, such as therapy duplications (eg, patients using multiple breakthrough narcotics or multiple sleep medications causing them to be too drowsy in the morning) or in drug interactions and adverse reactions.

This is particularly beneficial for our patients, because 95% of them (if not more) have multiple providers. Their oncologist is not their primary care physician (PCP) so they are seeing their PCP as well, and possibly even a cardiologist or a diabetes specialist. As a result, the patient may be seeing many physicians from different disciplines who are all prescribing medications and often are not talking to each other.

That is why it is beneficial for the pharmacist to be involved in the supportive care clinic and help with the medication reconciliations. We can help every provider know for sure what is going on with the patient, and we give that patient the updated medication list.

It would be beneficial to have a pharmacist sit down with every patient and review the medications, because we have found that even patients with cancer are not always reporting all the medications they are taking. Within this supportive

care clinic, we ask the patients to bring all their medication bottles, not a list but actual bottles, so that we can physically look at them and know for sure what they are taking.

The best suggestion I have for pharmacists is to talk to every patient. You can get a lot out of reading the progress notes and talking to the physician, but until you actually talk

Within this supportive care clinic, we ask the patients to bring all their medication bottles, not a list but actual bottles, so that we can physically look at them and know for sure what they are taking.

want to bother their doctors, because they are so busy. Therefore, a pharmacist can sometimes get information regarding side effects that he/she can share back with the physician, to help improve the care and symptom management of that patient.

Symptom management can involve the amount of pain the patient has, or medication side effects that they do not always want to talk about. Some of those side effects, especially with chemotherapy, can be easily managed at home, if they just let us know. For example, we can help to get their nausea under better control, or control mouth sores or mouth pain by providing rinses or special counseling points, such as avoiding alcohol-based mouthwash.

Opening that conversation with the patient can help give the patient peace of mind about what they should and should not be doing, and also give them a little more control over their disease itself, and their symptoms.

to the patient, you do not know exactly what is going on with that patient. We have found that especially in cancer care, patients do not always reveal everything to their physicians, in part because they do not want to disappoint their oncologist. They will sometimes reveal things to a pharmacist or a nurse rather than their physician. They may also worry that if they tell the treating physician they are having a side effect, the physician will reduce the dose of the chemotherapy. They associate that dose reduction with less likelihood of success of the chemotherapy. Another reason is that some patients say they do not

Conclusion The goal of including a pharmacist in the care of patients with cancer is to avoid creating a silo where the only focus is oncology. In reality, to treat patients with cancer, we must be able to treat the whole patient; this includes knowing, understanding, and reviewing the other comorbidities these patients may have. A pharmacist is uniquely trained to understand all the medications a patient may be using and how those interact with the cancer treatment medications. It is our hope that pharmacists will continue to have a key role in the treatment and management of cancer patients as part of the very important interdisciplinary team. l

March 2012

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www.OncPracticeManagement.com

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Legal Update

Understanding Office of Inspector…Continued from the cover fraud, waste, and abuse; identifying opportunities to improve program economy, efficiency, and effectiveness; and holding accountable those who do not meet program requirements or who violate Federal laws,”1 has taken a leading role in such investigations and audits.

OIG accomplishes its mandate by deploying its staff of approximately 1800 professionals throughout the United States to conduct audits, evaluations, and investigations, as well as coordinating and overseeing third parties conducting audit activities on OIG’s behalf.1 OIG investigates a wide variety of conduct,2 and may seek civil monetary penalties against any person who, for example: (i) presents or causes to be presented claims to a Federal health program that the person knows or should have known is for an item or service that was not provided as claimed or is false or fraudulent3; (ii) violates the antikickback statute by knowingly or willfully paying or receiving remuneration for referrals of federal healthcare program beneficiaries4; or (iii) presents or causes to be presented a claim that person knows or should know is for a service which may not be made under the physician self-referral or Stark law.5 In the past several months, OIG has reported on the following activity:

1

On or around January 17, 2012, Buchanan County Health Center in Iowa agreed to pay $406,030 for allegedly employing an individual that it knew or should have known was excluded from participating in federal healthcare programs, potentially violating the Civil Monetary Penalties Law.6

2

On or around November 30, 2011, as a result of a self-disclosure, Evergreen Health Center, PC, in Lebanon, MO, agreed to pay $83,012.58 for allegedly submitting

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claims for services not provided, potentially violating the Civil Monetary Penalties Law.6

3

On or around October 4, 2011, as a result of a self-disclosure, County of Monterey d/b/a Natividad Medical Center of California agreed to pay $174,508.46 for allegedly entering into a professional medical services agreement with a physician group for certain call coverage and clinic services where the compensation terms offered incentives for the physician group to refer private practice patients to the Center, potentially violating the Civil Monetary Penalties Law.7 Available statistics show that as a result of OIG’s efforts during fiscal year (FY) 2010, OIG reported recovering: (i) $3.8 billion in investigation receivables that were court ordered or agreed to be paid through civil settlements; and (ii) $1.1 billion in audit receivables as a result of OIG audit disallowance recommendations.1 Because of the many fruits of OIG’s labor, OIG has increased its efforts since FY 2010 to increase recoveries by incorporating more sophisticated reviews and expanding the scope of its investigations.

OIG Initiatives For many practices devoting their resources and attention to patient care, minimal time is spent reviewing operations and policies in a way that protects the practice against an OIG investigation or other audit initiative, which puts such practices at a severe disadvantage that is somewhat easily preventable. Certainly, some practices that are targeted by OIG or other authorities or payers are in the category of committing egregious wrongdoing, whereas others have simply not taken the time to ensure that they are operating under the

ONCOLOGY PRACTICE MANAGEMENT

I March 2012

proper structure. Staying abreast of the changes to the numerous documentation requirements while also taking care of your patient population is not an easy task. There are, however, certain steps you may take to place yourself in a better position to limit exposure. Understanding the OIG Work Plan for Fiscal Year 2012 is one such step. OIG’s initiatives are not a secret; in fact, each October, OIG publishes its initiatives for the coming year. Reviewing the Work Plan and understanding where areas of exposure may exist in your practice is a somewhat simple first step to limiting exposure. Two examples of oncologyrelated initiatives are as follows:

1

Payments for off-label anticancer pharmaceuticals and biologicals: OIG states that it will focus a review on “Medicare payments for drugs and biologicals used on an off-label basis …in anticancer chemotherapeutic regimens to determine whether patients with particular indications were prescribed anticancer drugs approved by FDA for such indications before resorting to anticancer drugs not approved for those indications.”8

2

Medicare outpatient payments for drugs: OIG will review Medicare outpatient payments to providers for certain drugs and the administration of those drugs (eg, chemotherapy) to determine whether Medicare overpaid providers because of incorrect coding or overbilling of units.8 OIG explains that prior reviews have identified certain drugs, particularly chemotherapy drugs, as vulnerable to incorrect coding.

OIG provides additional insight into the 2 aforementioned initiatives by stating that in calendar year 2007, Medicare payments for anticancer drugs totaled approximately $2.7 bilContinued on page 22

“Quality care is everyone’s business.”

Beth Faiman, RN, MSN, APRN, BC, AOCN Nurse Practitioner, Multiple Myeloma Program Cleveland Clinic Taussig Cancer Institute Cleveland, OH

6

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Understanding Office of Inspector…Continued from page 20 lion, which as is readily apparent by OIG’s Work Plan, is more money than OIG believes was proper for reimbursement. Practices billing for anticancer drugs will be targeted this year, as specified in OIG’s Work Plan, and how those practices will be selected will likely be a result of data mining.

The initiated investigations will focus on whether those targeted practices and providers accurately and completely billed for services provided, and also whether such providers have reported units of service as the number of times that a service or procedure was performed.8 For those practices targeted for prescribing off-label drugs, OIG specified it will be looking to determine whether there were improvements in the patients’ medical condition before the use of offlabel drugs. The OIG Work Plan states that “if the beneficiaries’ medical conditions improved before the use of off-label drugs, [OIG] will determine how much Medicare could have saved had the previously administered anticancer drugs continued to be used,”8 and presumably seek to recoup such amounts from the practice. OIG states as its authority to recoup such monies that “Medicare covers FDA-approved drugs used for off-label indications in anticancer chemotherapeutic regimens when such uses are supported in authoritative compendia identified by the Secretary of HHS.”8

Ramifications of Exposure When appropriate, OIG has the authority to impose civil monetary penalties assessments and administrative sanctions, as well as collaborating with the Department of Justice and other government executive branch agencies capable of bringing charges.1 OIG is authorized to seek different amounts of civil monetary penalties and assessments based on the type of violation at issue.9 For example, in a

22

I

case of false or fraudulent claims, the OIG may seek a penalty of up to $10,000 for each item or service improperly claimed, and an assessment of up to 3 times the amount improperly claimed.10 In a kickback case, OIG may seek a penalty of up to $50,000 for each improper act and damages of up to 3 times the amount of remuneration at issue (regardless of whether some of the remuneration was for a lawful purpose).11

Protecting Your Practice Protecting your practice from an OIG investigation begins with preventive compliance. This entails ensuring that your practice is properly structured to comply with numerous rules and regulations, including the self-referral laws. To place your practice in the best position possible, you should seek the advice of competent healthcare counsel to either structure your practice when it is created or to review your existing structure for compliance. In addition to proper structuring, your practice should adopt policies and procedures to govern how your practice operates, including the adoption of a compliance plan that details acceptable billing practices.

Also, as part of your practice’s compliance, I strongly recommend working with an external coding and billing expert, brought in specifically to examine your practice and diagnose any areas of exposure. Although you may have a dynamic team in place handling the billing operations for your practice, having a review of your documentation and coding by an expert specializing in your practice area who has reviewed documentation and coding of many other practices and is familiar with billing requirements for your specialty will not only likely place you in a more protected position, but also potentially highlight areas where you may increase your accounts receivable.

ONCOLOGY PRACTICE MANAGEMENT

I March 2012

The bottom line with investigations such as OIG’s initiatives is that with electronic records and billing, oversight has dramatically changed and it is now much easier to target practices potentially overutilizing, upcoding, or abusing the reimbursement system. Those practices continuing with “business as usual,” and ignoring the warning signs that it is time to adapt and modify as the oversight has, will likely have a much greater chance of being targeted. l References

1. US Department of Health & Human Services, Office of Inspector General Work Plan: Fiscal Year 2012.

Introductory message from the Office of Inspector General. http://oig.hhs.gov/reports-and-publications/ archives/workplan/2012/WP00-Intro.pdf. Accessed March 6, 2012.

2. 42 CFR § 1003.102.

3. 42 U.S.C. § 1320a-7a(a)(1)(A) and (B).

4. 42 U.S.C. § 1320a-7b(b); 42 U.S.C. § 1320a7a(a)(7).

5. 42 U.S.C. § 1395nn(g)(3).

6. US Department of Health & Human Services, Office of Inspector General. False and fraudulent claims. http://oig.hhs.gov/fraud/enforcement/cmp/false_claims. asp. Accessed March 6, 2012.

7. US Department of Health & Human Services, Office of Inspector General. Kickback and physician self-referral. http://oig.hhs.gov/fraud/enforcement/cmp/kick back.asp. Accessed March 6, 2012.

8. US Department of Health & Human Services, Office of Inspector General Work Plan: Fiscal Year 2012 Part I: Medicare Part A and Part B. http://oig.hhs.gov/reportsand-publications/archives/workplan/2012/WP01Mcare_A+B.pdf. Accessed March 6, 2012.

9. HHS OIG Work Plan | FY 2012 Introductory Message: http://oig.hhs.gov/reports-and-publications/ archives/workplan/2012/WP00-Intro.pdf.

10. 42 CFR § 1003.103.

11. 42 U.S.C. § 1320a-7a.

This article is for education and discussion purposes only and does not constitute legal advice.

Jennifer Kirschenbaum, Esq, manages Kirschenbaum & Kirschenbaum’s health-care department, which specializes in representing healthcare practitioners in regulatory compliance, audit defense, licensure, and transactional matters. Erica Youngerman, Esq, is an associate in Kirschenbaum & Kirschenbaum’s healthcare practice. If you have a question for Jennifer or if you would like to discuss ways to protect your practice, she can be reached at 516-747-6700 x302 or by e-mail at Jennifer@kirschenbaum esq.com. For more information about Kirschenbaum & Kirschenbaum’s healthcare practice, visit www.nyhealthcareattorneys.com.

Announcing: J-code for YERVOYâ&#x201E;˘ (ipilimumab) J9228 Indication

a

Replaces J9999, J99 999,, J3490,, J3590,, and C9284.

50-mg/10 mL (5 mg/mL), single-use vial of YER VOY YERVOY

200-mg/40 mL (5 mg/mL), single-use vial of YER VOY YERVOY

10-digit

0003-2327-11

0003-2328-22

11-digit

00003-2327-11

00003-2328-22

Product Description NDC Number

The accurate completion of reimbursement- or coverage-related documentation is the responsibility of the healthcare provider and patient. Bristol-Myers Squibb and its agents make no guarantee uarantee e regarding reimbursement for any service or item. This coding guidance is not intended to provide specific directions on requesting prior authorization or submitting claims for YER VOY and does not provide a guarantee of receiving prior authorization or YERVOY reimbursement. Oncology practices need to make coding decisions based on the diagnosis and treatment of each patient and the specific insurer requirements. www.destinationaccess.com 1-800-861-0048 (phone) Monday through Friday, 8:00 1-888-776-2370 (fax)

Important Safety Information WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS

1.

2.

AM

to 8:00

PM

ET

Important Safety Information (cont) Recommended Dose Modifications t

t

Immune-mediated Hepatitis: t

t t

t

t

t

Immune-mediated Enterocolitis: t

t Immune-mediated Dermatitis: t

t

t t t

t

t t

Important Safety Information (cont) t

Immune-mediated Neuropathies: t t t t

Other Immune-mediated Adverse Reactions, Including Ocular Manifestations: t

t t Immune-mediated Endocrinopathies: t t

t

t

t t

Pregnancy & Nursing: t

t t

Common Adverse Reactions: t

YERVOYâ&#x201E;˘ (ipilimumab) Injection, for intravenous infusion Brief Summary of Prescribing Information. For complete prescribing information consult official package insert.

WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS YERVOY (ipilimumab) can result in severe and fatal immune-mediated adverse reactions due to T-cell activation and proliferation. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY. Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions. [See Dosage and Administration (2.2) in Full Prescribing Information] Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests and thyroid function tests at baseline and before each dose. [See Warnings and Precautions] INDICATIONS AND USAGE YERVOY (ipilimumab) is indicated for the treatment of unresectable or metastatic melanoma.

CONTRAINDICATIONS None.

WARNINGS AND PRECAUTIONS YERVOY can result in severe and fatal immune-mediated reactions due to T-cell activation and proliferation.

[See Boxed Warning] Immune-mediated Enterocolitis In Study 1, severe, life-threatening, or fatal (diarrhea of 7 or more stools above baseline, fever, ileus, peritoneal signs; Grade 3â&#x20AC;&#x201C;5) immune-mediated enterocolitis occurred in 34 (7%) YERVOY-treated patients, and moderate (diarrhea with up to 6 stools above baseline, abdominal pain, mucus or blood in stool; Grade 2) enterocolitis occurred in 28 (5%) YERVOY-treated patients. Across all YERVOY-treated patients (n=511), 5 (1%) patients developed intestinal perforation, 4 (0.8%) patients died as a result of complications, and 26 (5%) patients were hospitalized for severe enterocolitis.

The median time to onset was 7.4 weeks (range 1.6â&#x20AC;&#x201C;13.4) and 6.3 weeks (range 0.3â&#x20AC;&#x201C;18.9) after the initiation of YERVOY for patients with Grade 3â&#x20AC;&#x201C;5 enterocolitis and with Grade 2 enterocolitis, respectively.

Twenty-nine patients (85%) with Grade 3â&#x20AC;&#x201C;5 enterocolitis were treated with high-dose (â&#x2030;Ľ40 mg prednisone equivalent per day) corticosteroids, with a median dose of 80 mg/day of prednisone or equivalent; the median duration of treatment was 2.3 weeks (ranging up to 13.9 weeks) followed by corticosteroid taper.

Of the 28 patients with moderate enterocolitis, 46% were not treated with systemic corticosteroids, 29% were treated with <40 mg prednisone or equivalent per day for a median duration of 5.1 weeks, and 25% were treated with high-dose corticosteroids for a median duration of 10 days prior to corticosteroid taper. Infliximab was administered to 5 of the 62 patients (8%) with moderate, severe, or life-threatening immune-mediated enterocolitis following inadequate response to corticosteroids.

Of the 34 patients with Grade 3â&#x20AC;&#x201C;5 enterocolitis, 74% experienced complete resolution, 3% experienced improvement to Grade 2 severity, and 24% did not improve. Among the 28 patients with Grade 2 enterocolitis, 79% experienced complete resolution, 11% improved, and 11% did not improve.

Monitor patients for signs and symptoms of enterocolitis (such as diarrhea, abdominal pain, mucus or blood in stool, with or without fever) and of bowel perforation (such as peritoneal signs and ileus). In symptomatic patients, rule out infectious etiologies and consider endoscopic evaluation for persistent or severe symptoms.

Permanently discontinue YERVOY in patients with severe enterocolitis and initiate systemic corticosteroids at a dose of 1 to 2 mg/kg/day of prednisone or equivalent. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least one month. In clinical trials, rapid corticosteroid tapering resulted in recurrence or worsening symptoms of enterocolitis in some patients.

Withhold YERVOY dosing for moderate enterocolitis; administer anti-diarrheal treatment and, if persistent for more than one week, initiate systemic corticosteroids at a dose of 0.5 mg/kg/day prednisone or equivalent. [See Dosage and Administration (2.2) in Full Prescribing Information] Immune-mediated Hepatitis In Study 1, severe, life-threatening, or fatal hepatotoxicity (AST or ALT elevations of more than 5 times the upper limit of normal or total bilirubin elevations more than 3 times the upper limit of normal; Grade 3â&#x20AC;&#x201C;5) occurred in 8 (2%) YERVOY-treated patients, with fatal hepatic failure in 0.2% and hospitalization in 0.4% of YERVOY-treated patients. An additional 13 (2.5%) patients experienced moderate hepatotoxicity manifested by liver function test abnormalities (AST or ALT elevations of more than 2.5 times but not more than 5 times the upper limit of normal or total bilirubin elevation of more than 1.5 times but not more than 3 times the upper limit of normal; Grade 2). The underlying pathology was not ascertained in all patients but in some instances included immune-mediated hepatitis. There were insufficient numbers of patients with biopsyproven hepatitis to characterize the clinical course of this event.

The median time to onset of moderate, severe, or life-threatening immune-mediated dermatitis was 3.1 weeks and ranged up to 17.3 weeks from the initiation of YERVOY (ipilimumab).

Seven (54%) YERVOY-treated patients with severe dermatitis received high-dose corticosteroids (median dose 60 mg prednisone/day or equivalent) for up to 14.9 weeks followed by corticosteroid taper. Of these 7 patients, 6 had complete resolution; time to resolution ranged up to 15.6 weeks.

Of the 63 patients with moderate dermatitis, 25 (40%) were treated with systemic corticosteroids (median of 60 mg/day of prednisone or equivalent) for a median of 2.1 weeks, 7 (11%) were treated with only topical corticosteroids, and 31 (49%) did not receive systemic or topical corticosteroids. Forty-four (70%) patients with moderate dermatitis were reported to have complete resolution, 7 (11%) improved to mild (Grade 1) severity, and 12 (19%) had no reported improvement.

Monitor patients for signs and symptoms of dermatitis such as rash and pruritus. Unless an alternate etiology has been identified, signs or symptoms of dermatitis should be considered immune-mediated.

Permanently discontinue YERVOY in patients with Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations.

Administer systemic corticosteroids at a dose of 1 to 2 mg/kg/day of prednisone or equivalent. When dermatitis is controlled, corticosteroid tapering should occur over a period of at least 1 month. Withhold YERVOY dosing in patients with moderate to severe signs and symptoms. [See Dosage and Administration (2.2) in Full Prescribing Information] For mild to moderate dermatitis, such as localized rash and pruritus, treat symptomatically. Administer topical or systemic corticosteroids if there is no improvement of symptoms within 1 week.

Immune-mediated Neuropathies In Study 1, one case of fatal Guillain-BarrĂŠ syndrome and one case of severe (Grade 3) peripheral motor neuropathy were reported. Across the clinical development program of YERVOY, myasthenia gravis and additional cases of Guillain-BarrĂŠ syndrome have been reported.

Monitor for symptoms of motor or sensory neuropathy such as unilateral or bilateral weakness, sensory alterations, or paresthesia. Permanently discontinue YERVOY in patients with severe neuropathy (interfering with daily activities) such as Guillain-BarrĂŠ-like syndromes. Institute medical intervention as appropriate for management of severe neuropathy. Consider initiation of systemic corticosteroids at a dose of 1 to 2 mg/kg/day prednisone or equivalent for severe neuropathies. Withhold YERVOY dosing in patients with moderate neuropathy (not interfering with daily activities). [See Dosage and Administration (2.2) in Full Prescribing Information] Immune-mediated Endocrinopathies In Study 1, severe to life-threatening immune-mediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3â&#x20AC;&#x201C;4) occurred in 9 (1.8%) YERVOY-treated patients. All 9 patients had hypopituitarism and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. Six of the 9 patients were hospitalized for severe endocrinopathies. Moderate endocrinopathy (requiring hormone replacement or medical intervention; Grade 2) occurred in 12 (2.3%) patients and consisted of hypothyroidism, adrenal insufficiency, hypopituitarism, and one case each of hyperthyroidism and Cushingâ&#x20AC;&#x2122;s syndrome. The median time to onset of moderate to severe immune-mediated endocrinopathy was 11 weeks and ranged up to 19.3 weeks after the initiation of YERVOY. Of the 21 patients with moderate to life-threatening endocrinopathy, 17 patients required long-term hormone replacement therapy including, most commonly, adrenal hormones (n=10) and thyroid hormones (n=13).

Monitor patients for clinical signs and symptoms of hypophysitis, adrenal insufficiency (including adrenal crisis), and hyper- or hypothyroidism. Patients may present with fatigue, headache, mental status changes, abdominal pain, unusual bowel habits, and hypotension, or nonspecific symptoms which may resemble other causes such as brain metastasis or underlying disease. Unless an alternate etiology has been identified, signs or symptoms of endocrinopathies should be considered immune-mediated.

Monitor thyroid function tests and clinical chemistries at the start of treatment, before each dose, and as clinically indicated based on symptoms. In a limited number of patients, hypophysitis was diagnosed by imaging studies through enlargement of the pituitary gland.

Withhold YERVOY dosing in symptomatic patients. Initiate systemic corticosteroids at a dose of 1 to 2 mg/kg/day of prednisone or equivalent, and initiate appropriate hormone replacement therapy. [See Dosage and Administration (2.2) in Full Prescribing Information] Other Immune-mediated Adverse Reactions, Including Ocular Manifestations The following clinically significant immune-mediated adverse reactions were seen in less than 1% of YERVOY-treated patients in Study 1: nephritis, pneumonitis, meningitis, pericarditis, uveitis, iritis, and hemolytic anemia.

Across the clinical development program for YERVOY, the following likely immune-mediated adverse reactions were also reported with less than 1% incidence: myocarditis, angiopathy, temporal arteritis, vasculitis, polymyalgia rheumatica, conjunctivitis, blepharitis, episcleritis, scleritis, leukocytoclastic vasculitis, erythema multiforme, psoriasis, pancreatitis, arthritis, and autoimmune thyroiditis.

Permanently discontinue YERVOY for clinically significant or severe immune-mediated adverse reactions.

Initiate systemic corticosteroids at a dose of 1 to 2 mg/kg/day prednisone or equivalent for severe immunemediated adverse reactions.

Monitor liver function tests (hepatic transaminase and bilirubin levels) and assess patients for signs and symptoms of hepatotoxicity before each dose of YERVOY. In patients with hepatotoxicity, rule out infectious or malignant causes and increase frequency of liver function test monitoring until resolution.

Administer corticosteroid eye drops to patients who develop uveitis, iritis, or episcleritis. Permanently discontinue YERVOY for immune-mediated ocular disease that is unresponsive to local immunosuppressive therapy. [See Dosage and Administration (2.2) in Full Prescribing Information]

Permanently discontinue YERVOY in patients with Grade 3â&#x20AC;&#x201C;5 hepatotoxicity and administer systemic corticosteroids at a dose of 1 to 2 mg/kg/day of prednisone or equivalent. When liver function tests show sustained improvement or return to baseline, initiate corticosteroid tapering and continue to taper over 1 month. Across the clinical development program for YERVOY, mycophenolate treatment has been administered in patients who have persistent severe hepatitis despite high-dose corticosteroids. Withhold YERVOY in patients with Grade 2 hepatotoxicity. [See Dosage and Administration (2.2) in Full Prescribing Information]

ADVERSE REACTIONS

Immune-mediated Dermatitis In Study 1, severe, life-threatening, or fatal immune-mediated dermatitis (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3â&#x20AC;&#x201C;5) occurred in 13 (2.5%) YERVOY-treated patients. One (0.2%) patient died as a result of toxic epidermal necrolysis and one additional patient required hospitalization for severe dermatitis. There were 63 (12%) patients with moderate (Grade 2) dermatitis.

The following adverse reactions are discussed in greater detail in other sections of the labeling.

t *NNVOF NFEJBUFE FOUFSPDPMJUJT [see Warnings and Precautions].

t *NNVOF NFEJBUFE IFQBUJUJT [see Warnings and Precautions].

t *NNVOF NFEJBUFE EFSNBUJUJT [see Warnings and Precautions].

t *NNVOF NFEJBUFE OFVSPQBUIJFT [see Warnings and Precautions].

t *NNVOF NFEJBUFE FOEPDSJOPQBUIJFT [see Warnings and Precautions].

t 0 UIFS JNNVOF NFEJBUFE BEWFSTF SFBDUJPOT JODMVEJOH PDVMBS NBOJGFTUBUJPOT [see Warnings and Precautions].

Clinical Trials Experience

Immunogenicity

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared with rates in other clinical trials or experience with therapeutics in the same class and may not reflect the rates observed in clinical practice.

In clinical studies, 1.1% of 1024 evaluable patients tested positive for binding antibodies against ipilimumab in an electrochemiluminescent (ECL) based assay. This assay has substantial limitations in detecting anti-ipilimumab antibodies in the presence of ipilimumab. Infusion-related or peri-infusional reactions consistent with hypersensitivity or anaphylaxis were not reported in these 11 patients nor were neutralizing antibodies against ipilimumab detected.

The clinical development program excluded patients with active autoimmune disease or those receiving systemic immunosuppression for organ transplantation. Exposure to YERVOY (ipilimumab) 3 mg/kg for four doses given by intravenous infusion in previously treated patients with unresectable or metastatic melanoma was assessed in a randomized, double-blind clinical study (Study 1). [See Clinical Studies (14) in Full Prescribing Information] One hundred thirty-one patients (median age 57 years, 60% male) received YERVOY as a single agent, 380 patients (median age 56 years, 61% male) received YERVOY with an investigational gp100 peptide vaccine (gp100), and 132 patients (median age 57 years, 54% male) received gp100 peptide vaccine alone. Patients in the study received a median of 4 doses (range 1 to 4 doses). YERVOY was discontinued for adverse reactions in 10% of patients.

The most common adverse reactions (â&#x2030;Ľ5%) in patients who received YERVOY at 3 mg/kg were fatigue, diarrhea, pruritus, rash, and colitis.

Table 1 presents selected adverse reactions from Study 1, which occurred in at least 5% of patients in the YERVOY-containing arms and with at least 5% increased incidence over the control gp100 arm for all-grade events and at least 1% incidence over the control group for Grade 3â&#x20AC;&#x201C;5 events.

Table 1:

Percentage (%) of YERVOY 3 mg/kg n=131

Gastrointestinal Disorders Diarrhea Colitis Skin and Subcutaneous Tissue Disorders Pruritus Rash General Disorders and Administration Site Conditions Fatigue a

YERVOY 3 mg/kg+gp100 n=380

gp100 n=132

Any Grade

Grade 3â&#x20AC;&#x201C;5

Any Grade

Grade 3â&#x20AC;&#x201C;5

Any Grade

Grade 3â&#x20AC;&#x201C;5

32 8

5 5

37 5

4 3

20 2

1 0

31 29

0 2

21 25

<1 2

11 8

0 0

No formal drug-drug interaction studies have been conducted with YERVOY (ipilimumab).

USE IN SPECIFIC POPULATIONS Pregnancy

41

7

34

5

31

3

In a combined study of embryo-fetal and peri-postnatal development, severe toxicities including increased incidences of third-trimester abortion, stillbirth, premature delivery, low birth weight, and infant mortality occurred following intravenous administration of ipilimumab to pregnant cynomolgus monkeys every 21 days from the onset of organogenesis through parturition at doses of 2.6 or 7.2 times the recommended human dose of 3 mg/kg (by AUC). [See Nonclinical Toxicology (13.2) in Full Prescribing Information] In genetically engineered mice in which the gene for CTLA-4 has been deleted (a â&#x20AC;&#x153;knockout mouseâ&#x20AC;?), offspring lacking CTLA-4 were born apparently healthy, but died within 3â&#x20AC;&#x201C;4 weeks due to multi-organ infiltration and damage by lymphocytes.

Human IgG1 is known to cross the placental barrier and ipilimumab is an IgG1; therefore, ipilimumab has the potential to be transmitted from the mother to the developing fetus.

Nursing Mothers

Table 2 presents the per-patient incidence of severe, life-threatening, or fatal immune-mediated adverse reactions from Study 1.

Severe to Fatal Immune-mediated Adverse Reactions in Study 1 Percentage (%) of Patients

e

DRUG INTERACTIONS

There are no adequate and well-controlled studies of YERVOY in pregnant women. Use YERVOY during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Patientsa

Incidences presented in this table are based on reports of adverse events regardless of causality.

Table 2:

Immunogenicity assay results are highly dependent on several factors including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to YERVOY with the incidences of antibodies to other products may be misleading.

Pregnancy Category C

Selected Adverse Reactions in Study 1

System Organ Class/ Preferred Term

Because trough levels of ipilimumab interfere with the ECL assay results, a subset analysis was performed in the dose cohort with the lowest trough levels. In this analysis, 6.9% of 58 evaluable patients, who were treated with 0.3 mg/kg dose, tested positive for binding antibodies against ipilimumab.

Any Immune-mediated Adverse Reaction Enterocolitisa,b Hepatotoxicitya Dermatitisa Neuropathya Endocrinopathy Hypopituitarism Adrenal insufficiency Other Pneumonitis Meningitis Nephritis Eosinophiliac Pericarditisa,c

YERVOY 3 mg/kg n=131

YERVOY 3 mg/kg+gp100 n=380

15 7 1 2 1 4 4 0

12 7 2 3 <1 1 1 1

0 0 1 1 0

<1 <1 0 0 <1

It is not known whether ipilimumab is secreted in human milk. Because many drugs are secreted in human milk and because of the potential for serious adverse reactions in nursing infants from YERVOY, a decision should be made whether to discontinue nursing or to discontinue YERVOY, taking into account the importance of YERVOY to the mother.

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

Geriatric Use Of the 511 patients treated with YERVOY at 3 mg/kg, 28% were 65 years and over. No overall differences in safety or efficacy were reported between the elderly patients (65 years and over) and younger patients (less than 65 years).

Renal Impairment No formal studies of YERVOY in patients with renal impairment have been conducted. [See Clinical Pharmacology (12.3) in Full Prescribing Information] Hepatic Impairment No formal studies of YERVOY in patients with hepatic impairment have been conducted. [See Clinical Pharmacology (12.3) in Full Prescribing Information] OVERDOSAGE There is no information on overdosage with YERVOY. PATIENT COUNSELING INFORMATION See MEDICATION GUIDE in Full Prescribing Information. t *OGPSN QBUJFOUT PG UIF QPUFOUJBM SJTL PG JNNVOF NFEJBUFE BEWFSTF SFBDUJPOT t "EWJTF QBUJFOUT UP SFBE UIF :&370: .FEJDBUJPO (VJEF CFGPSF FBDI :&370: JOGVTJPO t "EWJTF XPNFO UIBU :&370: NBZ DBVTF GFUBM IBSN t "EWJTF OVSTJOH NPUIFST OPU UP CSFBTU GFFE XIJMF UBLJOH :&370:

Manufactured by: Bristol-Myers Squibb Company Princeton, NJ 08543 USA

a

Including fatal outcome.

Including intestinal perforation. c Underlying etiology not established. b

Across clinical studies that utilized YERVOY doses ranging from 0.3 to 10 mg/kg, the following adverse reactions were also reported (incidence less than 1% unless otherwise noted): urticaria (2%), large intestinal ulcer, esophagitis, acute respiratory distress syndrome, renal failure, and infusion reaction.

Based on the experience in the entire clinical program for melanoma, the incidence and severity of enterocolitis and hepatitis appear to be dose dependent.

d

1281558A2

IP-B0001A-03-11

Issued: March 2011

Cancer Center Business Summit

Compliance with Fair Market Value Critical to Hospital-Oncologist Alignments

By Wayne Kuznar

Chicago, IL—Compliance with fair market value is critical for regulatory compliance in valuations of oncologist-hospital alignments, whether these are professional service agreements or comanagement arrangements, according to presenters at the 2011 Cancer Center Business Summit.

“Professional service agreements comanagement arrangements seem to be where the principal action is currently,” said Michael L. Blau, Esq, Chair, Health Care Venture Practice, and Partner at Foley & Lardner, LLP. “For the physician, a professional service agreement is an economic win, because when physicians enter into a relationship with a hospital, the hospital is at least going to hold them harmless in terms of their current compensation,” he said.

Under professional service agreements, a contract is drawn up in which the purchased entity enters into a contract with the purchasing hospital to staff the hospital’s facilities in exchange for fair market compensation. Fair market value compensation in an arrangement such as this one can be paid on an aggregate fixed fee or a relative value unit (RVU) basis, Mr Blau pointed out.

The risk of reimbursement reductions would be eliminated if an RVU is locked in over a valuation period of 2 or 3 years, he said, and free care and bad debt during this period would be risks taken on by the hospital rather than the physician group.

The professional service agreements arrangement is also a win for the hospital, because it has an opportunity to capture an entire service

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line of business that it could not previously, he noted. It picks up the entire business, not at the physician office rate, but at the hospital outpatient payment rate, which in most states will be between 120% and 180% of what otherwise would be paid to the physicians,” he said.

Under-arrangement transactions, in which the hospital takes lease assignment of leases of sites from

“A valuation firm is not an advocate for either the physician group or the hospital.”

—Darryl P. Johnson

landlords of the purchased entity and that entity performs the service, are now prohibited under the Stark Law, said Mr Blau. “The way to get around this is to disaggregate from the group certain assets, so the group is in a legally defensible position to say it is not performing the service, but the hospital is the entity that is performing the service,” he added.

One way to do this is to have space not provided by the group but by an independent third-party landlord. “Even if physicians own the space, they usually have a real estate trust as an entity that is separate from the practice that owns the space,” he explained.

The equipment can be sold to the hospital for fair market value “so that the hospital ends up providing the

ONCOLOGY PRACTICE MANAGEMENT

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equipment,” Mr Blau said. With an unwind clause written into the contract, the physicians reserve the right to get the equipment back at the end of the transaction.

The physician group would then be left as a staffing service, which it can lease to the hospital. A 2% to 3% administrative handling fee paid to the physician group can also be worked into the agreement, he said, as well as a billing fee if the group is responsible for billing and collection.

Hiring an experienced fair market value appraiser “with an opinion you can rely on” is strongly advised to receive a proper valuation and thus avoid conflict with the Stark law.

Reasonable compensation will also be determined by a fair market value opinion.

“A valuation firm is not an advocate for either the physician group or the hospital,” said Darryl P. Johnson, Managing Partner, HealthCare Appraisers, Inc. One of the misunderstood concepts about certain professional service agreements transactions is that “notwithstanding the fact that the hospital is getting a tremendous potential uptick from 340b drug pricing and its ability to bill as a facility-based provider, that value cannot be shared with the physicians,” he said.

This ability to bill as a facilitybased provider is still of benefit to the physician group, he said, because it helps build the case of a win-win arrangement. “It is beneficial to show that the arrangement is economically viable from the hospital’s standpoint and from the physician group’s standpoint,” Mr Blau concluded. l

Patient and Provider Access Brought to you by the Association of Community Cancer Centers

Oral Parity: Taking It to the Next Level

By Sydney Abbott, JD, Policy Coordinator, Association of Community Cancer Centers

I

magine that you are a patient who has been recently diagnosed with cancer. While you are still recovering from a difficult surgery to remove the tumor, your oncologist advises you it is time to begin chemotherapy. You are relieved to learn that your doctor has written a prescription for an oral anticancer medication, so you will not have to make weekly trips to the oncologist’s office for intravenous (IV) chemotherapy infusions. You promptly go to the pharmacy to fill the order.

But, when it is time to pay for your prescription, you may not feel so relieved—especially when you compare the out-of-pocket costs for the oral anticancer drug to your copay for receiving chemotherapy infusions in the outpatient setting.

The oral medication may cost you thousands of dollars more per month than your health insurance plan covers. This disparity between insurance coverage of oral versus infused medications is a dramatic example of technology outpacing policy, and, as an increasing number of oral agents become available, more and more patients across the country are experiencing this disparity in out-ofpocket costs.

Out-of-Pocket Costs: IV versus Oral Drugs Until recently, IV and injected treatments were the primary methods used in the treatment of cancer.

However, oral anticancer treatments have become more prevalent, and for certain types of cancer, oral therapies are now the standard of care.

Currently, approximately 10% of chemotherapies are available orally.

Furthermore, up to 35% of agents in oncology development are oral medications. For some patients with can-

cer, oral anticancer medications are the only treatment—no IV alternative exists.

In addition, studies have shown overall higher costs associated with IV infusions when considering the physician and nurse time required for

pocket cost is limited to the required copay for an office visit, which is usually between $20 and $30.

By contrast, oral chemotherapy medications are covered under a health plan’s pharmacy benefit, which means that patients may be responsible for higher levels of cost-sharing. Out-ofpocket cost for prescription benefits is often some percentage of the total cost of the anticancer medication.

Therefore, these copayments can amount to thousands of dollars monthly, and in extreme cases, they can cause patients to forgo necessary treatment altogether.

This disparity is a dramatic example of technology outpacing policy, and, as increasing number of oral agents become available, more and more patients across the country are experiencing this disparity in out-ofpocket costs.

State versus Federal Legislation States have recognized the seriousness of this problem, and since 2007, 15 state legislatures— Colorado, Connecticut, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Minnesota, New Mexico, New York, Oregon, Texas, Vermont, and Washington—and the District of Columbia have passed laws requiring health insurance plans to cover oral chemotherapy regimens under terms no less favorable than those offered for IV treatments. As of the publication date of this article, Maryland, Virginia, Missouri, and others are also considering similar legislation. But at the current rate that legislation is being passed in the states, it will take more than a decade to reach oral parity for every patient with cancer in the United States. Legislation at the national level would ensure equal access to

administration, not to mention the exponential rise in healthcare costs if there are complications from the administration of an IV therapy, such as an infection at the infusion site.

Insurance coverage policies have not kept up with the pace of cancer treatment technology. With the increasing numbers of emerging oral therapies, many health plans are creating inequity and access problems for patients, by covering infused chemotherapies at significantly lower out-ofpocket costs for patients than oral agents.

Currently, IV treatments are covered under the medical benefit portion of health insurance coverage.

This means the patient’s out-of-

March 2012

Continued on page 35

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Drug Coding Supplied by RJ Health Systems

Medications Used for the Treatment of Prostate Cancer The following sections will assist healthcare professionals and payers by providing appropriate coding and billing information associated with the management of prostate cancer.

The following sections include: • Associated ICD-9-CM codes used for the classification of prostate cancer • Drugs that have been FDA-approved in the treatment of prostate cancer • Drugs that are Compendia listed for offlabel use for prostate cancer based on clinical studies that suggest beneficial use in some cases.

Please note: if a check mark appears in the FDA column it will NOT appear in the Compendia off-label use column • Corresponding HCPCS/CPT® codes and code descriptions

30

Associated ICD-9-CM codes for prostate cancer: 185

Malignant neoplasm of prostate Excludes: seminal vesicles (187.8)

FDA-approved for prostate cancer

Compendia listed off-label use for prostate cancer

CPT ® administration codes

Generic (brand) name

HCPCS code: code description

abiraterone acetate (Zytiga)

J8999*: Prescription drug, oral, chemotherapeutic Not otherwise specified

✓

N/A

abiraterone acetate (Zytiga)

C9399*: Unclassified drugs or biologics (Hospital outpatient use only)

✓

N/A

bacillus Calmette-Guerin 90585: Bacillus Calmette-Guerin vaccine (Tice BCG) (BCG) for tuberculosis, live, for percutaneous use

✓

90471

bacillus Calmette-Guerin 90586: Bacillus Calmette-Guerin vaccine (Tice BCG, TheraCys) (BCG) for bladder cancer, live, for intravesical use

✓

51720

bacillus Calmette-Guerin J9031: BCG (intravesical), per installation (Tice BCG, TheraCys)

✓

51720

bevacizumab (Avastin)

J9035: Injection, bevacizumab, 10 mg

✓

96413, 96415

bicalutamide (Casodex)

J8999*: Prescription drug, oral, chemotherapeutic Not otherwise specified

✓

N/A

cabazitaxel (Jevtana)

J9043: Injection, cabazitaxel, 1 mg

✓

96413

cisplatin (Platinol AQ)

J9060: Injection, cisplatin, powder or solution, per 10 mg

✓

96409, 96413, 96415

cyclophosphamide (Cytoxan)

J8530: Cyclophosphamide, oral, 25 mg

✓

N/A

cyclophosphamide (Cytoxan)

J9070: Cyclophosphamide, 100 mg

✓

96409, 96413, 96415

degarelix (Firmagon)

J9155: Injection, degarelix, 1 mg

I

ONCOLOGY PRACTICE MANAGEMENT

I March 2012

✓

96402

Drug Coding Supplied by RJ Health Systems

Generic (brand) name

HCPCS code: code description

dexamethasone (Decadron) docetaxel (Taxotere, Docefrez) doxorubicin (Adriamycin) epirubicin (Ellence) estradiol valerate (Delestrogen) estramustine (Emcyt)

J8540: Dexamethasone, oral, 0.25 mg

FDA-approved for prostate cancer

✓

J9171: Injection, docetaxel, 1 mg

CPT ® administration codes N/A 96413

✓

J9000: Injection, doxorubicin hydrochloride, 10 mg J9178: Injection, epirubicin HCl, 2 mg

J1380: Injection, estradiol valerate, up to 10 mg J8999*: Prescription drug, oral, chemotherapeutic Not otherwise specified estrogens (eg, estradiol, J8499*: Prescription drug, oral, conjugated estrogen, nonchemotherapeutic esterified estrogen) Not otherwise specified fluorouracil J9190: Injection, fluorouracil, 500 mg (Adrucil) flutamide J8999*: Prescription drug, oral, (Eulexin) chemotherapeutic Not otherwise specified flutamide S0175: Flutamide, oral, 125 mg (Eulexin) goserelin acetate J9202: Goserelin acetate implant, (Zoladex) per 3.6 mg histrelin J9225: Histrelin implant, 50 mg (Vantas) hydrocortisone J1720: Injection, hydrocortisone sodium (Solu-Cortef) succinate, up to 100 mg ixabepilone J9207: Injection, ixabepilone, 1 mg (Ixempra) ketoconazole J8499*: Prescription drug, oral, (Nizoral) nonchemotherapeutic Not otherwise specified leuprolide acetate J9217: Leuprolide acetate (Eligard, Lupron Depot) (for depot suspension), 7.5 mg leuprolide acetate J9218: Leuprolide acetate, per 1 mg (Lupron) medroxyprogesterone J1051: Injection, medroxyprogesterone (Depo-Provera) acetate, 50 mg megestrol J8499*: Prescription drug, oral, (Megace) nonchemotherapeutic Not otherwise specified megestrol S0179: Megestrol acetate, oral 20 mg (Megace) melphalan J8600: Melphalan, oral, 2 mg (Alkeran) melphalan J9245: Injection, melphalan hydrochloride, (Alkeran) 50 mg

Compendia listed off-label use for prostate cancer

✓

96409

✓

96409, 96413

✓

96372

✓

N/A

✓

N/A

✓

96409

✓

N/A

✓

N/A

✓

96372, 96402

✓

✓

11981, 11982, 11983 96365, 96366, 96372, 96374 96413, 96415

✓

N/A

✓

✓

96402

✓

96402

March 2012

I

✓

96402

✓

N/A

✓

N/A

✓

N/A

✓

96409, 96413

www.OncPracticeManagement.com

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Drug Coding Supplied by RJ Health Systems

FDA-approved for prostate cancer

Compendia listed off-label use for prostate cancer

CPT ® administration codes

Generic (brand) name

HCPCS code: code description

methylprednisolone (Medrol)

J7509: Methylprednisolone, oral, per 4 mg

✓

N/A

methylprednisolone (Depo-Medrol)

J1020: Injection, methylprednisolone acetate, 20 mg

✓

11900, 11901, 20600, 20605, 20610, 96372

methylprednisolone (Depo-Medrol)

J1030: Injection, methylprednisolone acetate, 40 mg

✓

11900, 11901, 20600, 20605, 20610, 96372

methylprednisolone (Depo-Medrol)

J1040: Injection, methylprednisolone acetate, 80 mg

✓

11900, 11901, 20600, 20605, 20610, 96372

methylprednisolone (Solu-Medrol)

J2920: Injection, methylprednisolone sodium succinate, up to 40 mg

✓

96365, 96366, 96372, 96374

methylprednisolone (Solu-Medrol)

J2930: Injection, methylprednisolone sodium succinate, up to 125 mg

✓

96365, 96366, 96372, 96374

mitoxantrone (Novantrone)

J9293: Injection, mitoxantrone hydrochloride, per 5 mg

✓

96409, 96413

nilutamide (Nilandron)

J8999*: Prescription drug, oral, chemotherapeutic Not otherwise specified

✓

N/A

paclitaxel (Taxol)

J9265: Injection, paclitaxel, 30 mg

✓

96413, 96415

prednisone (Deltasone)

J7506: Prednisone, oral, per 5 mg

✓

N/A

✓

N/A

prednisolone J7510: Prednisolone, oral, per 5 mg (eg, Orapred, Millipred) sipuleucel-T (Provenge)

Q2043: Sipuleucel-T, minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF, including leukapheresis and all other preparatory procedures, per infusion (Code price is per 250 mL)

topotecan (Hycamtin)

J9351: Injection, topotecan, 0.1 mg

✓

96413

trastuzumab (Herceptin)

J9355: Injection, trastuzumab, 10 mg

✓

96413, 96415

triptorelin (Trelstar Depot, Trelstar LA)

J3315: Injection, triptorelin pamoate, 3.75 mg

vinBLAStine (Velban)

J9360: Injection, vinblastine sulfate, 1 mg

96413, 96415

✓

96372, 96402

✓

✓

96409

*When billing a nonclassified medication using a CMS 1500 claim form, you must include both the HCPCS code in Column 24D and the drug name, strength, and NDC (National Drug Code) in Box 19 or Column 24A to ensure appropriate reimbursement. Please note: Check with payer regarding correct placement of medication information.

References • HCPCS Level II Expert 2012 • Current Procedural Terminology (CPT®), 2011 (CPT® copyright 2011. American Medical Association. All rights reserved. CPT® is a registered trademark of the American Medical Association) • ICD-9-CM for Professionals Vol 1, 2, 2012 • FDA-approved indication (from product prescribing information) • Compendia references available upon request • www.ReimbursementCodes.com powered by RJ Health Systems International, LLC., Rocky Hill, Connecticut • CMS (Centers for Medicare & Medicaid Services).

BCG indicates Bacillus Calmette-Guerin; CPT, Current Procedural Terminology; HCPCS, Healthcare Common Procedure Coding System; PAP-GM-CSF, prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor.

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ONCOLOGY PRACTICE MANAGEMENT

I March 2012

RJ Health Systems The Creators of ReimbursementCodes.com

RJ Health Systems â&#x20AC;&#x201D; the pharmaceutical specialists that healthcare professionals have turned to since 1983 for their drug information.

We work with over 170 Payor organizations that touch approximately 110 million lives.

RJ Health Systems has established and continuously maintains a Library of Drug Intelligence that provides the most comprehensive, trusted, and up-to-date coding and reimbursement information in the industry.

ReimbursementCodes.com incorporates the CMS HCPCS and AMA CPT Drug codes into a system that crosswalks each drug code with the drugâ&#x20AC;&#x2122;s NDC and brand/generic name.

Please visit www.rjhealthsystems.com to learn more about our products and services listed below:

>> >> >> >> >> >> >> >> >>

ReimbursementCodes.com Drug Diagnosis Coding CMAC PartBorPartD.com NDC Conversion Database Min/Max Dosing Advisories Notations Clinical Consulting

rjhealthsystems.com

Health Policy

The End of Health Insurance Companies

By Ezekiel J. Emanuel and Jeffrey B. Liebman

H

ere’s a bold prediction for the new year. By 2020, the American health insurance industry will be extinct. Insurance companies will be replaced by accountable care organizations (ACOs) —groups of doctors, hospitals and other health care providers who come together to provide the full range of medical care for patients.

Already, most insurance companies barely function as insurers. Most non-elderly Americans—or 60 percent of Americans with employerprovided health insurance—work for companies that are self-insured.

In these cases it is the employer, not the insurance company, that assumes most of the risk of paying for the medical care of employees and their families. All that insurance companies do is process billing claims.

For individuals and small businesses, health insurance companies usually do provide insurance; they take a premium and assume financial responsibility for paying the bills. But the amount of risk sharing that is accomplished is limited because the insurers charge premiums that vary, depending on the health of an individual or a group of employees, and use their data and market power to identify healthy people to cover and unhealthy people to exclude from coverage. (The health care law’s total ban on exclusions for preexisting conditions will begin in 2014.)

Ezekiel J. Emanuel is a contributing opinion writer for The New York Times. Jeffrey B. Liebman is a professor of public policy at Harvard. Both were advisers in the Obama administration.

Reprinted with permission from The New York Times, January 30, 2012.

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A new system is on its way, one that will make insurance companies unnecessary.

Many health insurance companies also impose barriers—like requiring prior authorization for tests and treatments and denying payment for covered services, which forces patients to appeal—to discourage patients from using the medical services for which they are insured and to attempt to avoid paying for those services. While these barriers can reduce waste by preventing unnecessary care, they can also discourage patients from receiving care they need, as well as impose administrative burdens on doctors and patients.

But thanks to the ACOs provided for by the health care reform act, a new system is on its way, one that will make insurance companies unnecessary. ACOs will increase coordination of patient’s care and shift the focus of medicine away from treating sickness and toward keeping people healthy.

Because most physicians and hospitals today are paid on a fee-forservice basis, medical care is organized around treating a specific episode of illness rather than the whole patient. This system encourages overtreatment and leads to mistakes and miscommunication when patients are sent between their primary care doctors, specialists and hospitals. Indeed, under today’s payment system, investments in providing better care are doubly penalized.

If a hospital hires a nurse to follow up with patients after they are discharged in order to reduce readmissions—for example, to help patients with diabetes improve blood sugar control—it must pay for the nurse, which is typically not reimbursed by

ONCOLOGY PRACTICE MANAGEMENT

I March 2012

insurance companies or Medicare, and it loses revenue by preventing the readmission.

In contrast, ACOs will typically be paid a fixed amount per patient, along with bonuses for achieving quality targets. The organizations will make money by keeping their patients healthy and out of the hospital and by avoiding unnecessary tests, drugs and procedures. Thus, they will actually have a financial incentive to hire that nurse for follow-ups.

In addition to providing better and more efficient care, ACOs will also make health insurers superfluous. Because they will each be responsible for a large group of patients (typically more than 15,000), they will pool the risk of patients who have higher-thanaverage costs with those with lower costs. And with the end of fee-forservice payments, insurance companies will no longer be needed to handle complicated billing and claims processing, nor will they need to be paid a fee for doing so.

Payments can flow directly from an employer, Medicare or Medicaid to the ACOs. ACOs will require enhanced information systems to track patients and figure out how to deliver more effective care, but this analytic capacity will be directed at improving health outcomes, not at imposing barriers to those seeking treatment.

ACOs are not simply a return to the health maintenance organizations (HMOs) of the 1990s.

Although in both models patients are members of a provider network with a specific group of doctors and hospitals, and both are paid primarily per member rather than per Continued on page 35

Health Policy

The End of Health…Continued from page 34 procedure or test, there are big differences between them. HMOs were often large national corporations far removed from their members. In contrast, ACOs will consist of local health care providers working as a team to take care of patients who are likely to be members for years at a time. HMOs often cut costs not by keeping people healthy but by denying patients services and by forcing doctors and hospitals to take lower payments.

In the 1990s, we lacked the information technology and proven models of integrated care delivery that we have now. These advances will allow ACOs to simultaneously improve health outcomes and reduce costs.

A final bonus of ACOs is that

they will lead to a better form of competition in health care markets.

Today, consumers have to choose among insurance plans with a bewildering array of copayments, deductibles and annual out of pocket maximums—choices that few of us are any good at making. In the ACO model, consumers will choose a primary care physician and the team of doctors and hospitals that are in the same group. Choosing a doctor and provider group is a responsibility that consumers want to have and are likely to be much better at.

A few health insurers see this asteroid coming. WellPoint, for example, bought the clinic operator CareMore for $800 million last summer to make the transition into

the ACO business. Others, like the Optum unit of UnitedHealth Group, are developing data analysis services to provide to future ACOs. If they don’t want to go the way of the dinosaurs, insurance companies will have to find a new business to be in, one that is useful in the new world of coordinated care. l

Share your response to this article with your colleagues on the pages of Oncology Practice Management.

Send your comments to: editorial@engagehc.com

Patient and Provider Access Brought to you by the Association of Community Cancer Centers

Oral Parity: Taking It to the Next Level…Continued from page 29 the most appropriate treatment regimen for all patients. It is time for Congress to take action.

Medicare has already fixed this problem. Under Medicare Part D, any oral chemotherapy drug that is identical to an IV chemotherapy drug is covered under Medicare Part B’s medical benefits. Only private payers are not yet required to update insurance policies to keep pace with the changing landscape of quality cancer care.

Last fall, Congressman Brian

Higgins (NY-27) introduced the Cancer Drug Coverage Parity Act of 2011 (H.R. 2746). This bill, which is still making its way through Congress, has many supporters but has faced opposition from those who are concerned that this is a mandate.

However, H.R. 2746 does not propose to require plans to cover chemotherapy. Rather, it requires insurers that already cover chemotherapy treatments to provide for coverage of oral anticancer drugs on terms no less favorable than the cov-

March 2012

erage provided for intravenously administered medications.

The Association of Community Cancer Centers (ACCC) wants to see access to oral chemotherapy options protected for all cancer patients in the United States. We will continue to fight to preserve our members’ ability to prescribe the most appropriate treatment for their patients. The ACCC will monitor this issue and will notify members of state and federal efforts in this area. l

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Physician Wealth Management With Lawrence B. Keller, CLU, ChFC, CFP®

Business Disability Insurance and Your Medical Practice

A

lthough most physicians are aware that one of the greatest risks they face is becoming disabled and unable to perform the “material and substantial” duties of their medical specialty, most are unaware that myriad types of disability insurance policies exist to protect their medical practices. These types of policies can assure that ongoing business expenses can be met, that creditors can be paid, and that the medical practice or value of their business interest(s) will be preserved in the event that he or she is unable to return to the practice of medicine. My first article in this series is focused on the benefits of “key person replacement insurance.”

Key Person Replacement Insurance As a business owner, you probably rely on one or more key people throughout the day to keep your practice running effectively. A “key employee” is someone who contributes significantly to the financial success of a business. This person may be an office manager, a physician’s assistant, an employee physician, or even another physician owner. If any of these key people died or became disabled, what would that mean to the future of your practice? How would cash flow, revenues, profitability, and morale be affected?

What would patients and creditors think? The loss of revenue could be devastating.

Key person insurance is an effective way to provide a small- to medium-sized business with funds to han-

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dle the loss of a key employee as a result of disability or death. The employer pays the premium and is the owner of the policy insuring the key employee in the event of a total disability. If the key employee becomes

Key person insurance is an effective way to provide a small- to medium-sized business with funds to handle the loss of a key employee as a result of disability or death.

totally disabled, the employer receives benefits from the policy to offset costs such as recruitment and training, temporary staffing needs, and short-term revenue replacement.

As mentioned, often a similar type of policy can be purchased to protect the practice in the event of a key person’s premature death.

Perhaps one of the best applications of key person disability insurance is in the case of a medical practice that is owned by a husband and a wife. In these situations, traditional disability buy-out insurance would normally be unavailable. However, with key person disability insurance, as long as a nonmajority insured (owns ≤50% of the practice) meets the definition of total disability, the owner of the policy receives either a lump-sum payment or a combination of monthly and lump-sum payments, depending on how the policy is structured.

ONCOLOGY PRACTICE MANAGEMENT

I March 2012

Premium Rates Premium rates are dependent on many factors, including, but not limited to, age, gender, occupational classification, smoking status, benefit amount, elimination period, and riders selected. However, when multiple business owners and/or employees purchase a combination of disability income and business protection policies from the same insurance company, large discounts can typically be obtained. Additionally, these same discounts can be made available to employees interested in purchasing individual coverage. For these reasons, physicians and other business owners should consider working with the same insurance agent to design a plan to meet the individual needs of themselves and their businesses and to make sure that the policies purchased are integrated and coordinated, and that they take advantage of any available discounts.

Summary Although most physicians are keenly aware of the need to purchase individual disability insurance coverage, few are cognizant of the variety of disability insurance policies designed to help meet the needs of self-employed physicians and/or the shareholders of a medical practice. These include, but are not limited to disability business overhead expense insurance, key person replacement insurance, and disability buy-out insurance. l Lawrence B. Keller, CLU, ChFC, CFP®, is the founder of Physician Financial Services, a New York–based firm specializing in income protection and wealth accumulation strategies for physicians. He can be reached at 516-6776211 or Lkeller@physicianfinancial services.com for comments or questions.

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

INDICATIONS AND USAGE ZYTIGA in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) who have received prior chemotherapy containing docetaxel.

CONTRAINDICATIONS Pregnancy: ZYTIGA may cause fetal harm when administered to a pregnant woman. 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, the patient should be apprised of the potential hazard to the fetus.

WARNINGS AND PRECAUTIONS Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess: Use ZYTIGA with caution in patients with a history of cardiovascular disease. ZYTIGA may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition [see Adverse Reactions and Clinical Pharmacology (12.1) in full Prescribing Information]. 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. The safety of ZYTIGA in patients with left ventricular ejection fraction <50% or NYHA Class III or IV heart failure has not been established because these patients were excluded from the randomized clinical trial. 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: Adrenocortical insufficiency has been reported in clinical trials 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: Marked increases in liver enzymes leading to drug discontinuation or dosage modification have occurred [see Adverse Reactions]. 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.

Food Effect: 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 17- and 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].

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].

Food effect [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

ZYTIGA® (abiraterone acetate) Tablets directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In a placebo-controlled, multicenter phase 3 clinical trial of patients with metastatic castration-resistant prostate cancer who were using a gonadotropin-releasing hormone (GnRH) agonist or were previously treated with orchiectomy, ZYTIGA was administered at a dose of 1,000 mg daily in combination with prednisone 5 mg twice daily in the active treatment arm (N = 791). Placebo plus prednisone 5 mg twice daily was given to control patients (N = 394). The median duration of treatment with ZYTIGA was 8 months.

The most common adverse drug reactions (≥5%) reported in clinical studies were joint swelling or discomfort, hypokalemia, edema, muscle discomfort, hot flush, diarrhea, urinary tract infection, cough, hypertension, arrhythmia, urinary frequency, nocturia, dyspepsia, fractures and upper respiratory tract infection.

The most common adverse drug reactions that resulted in drug discontinuation were aspartate aminotransferase increased, alanine aminotransferase increased, urosepsis and cardiac failure (each in <1% of patients taking ZYTIGA).

Adverse reactions and laboratory abnormalities related to mineralocorticoid effects were reported more commonly in patients treated with ZYTIGA than in patients treated with placebo: hypokalemia 28% versus 20%, hypertension 9% versus 7% and fluid retention (edema) 27% versus 18%, respectively (see Table 1). In patients treated with ZYTIGA, grades 3 to 4 hypokalemia occurred in 5% of patients and grades 3 to 4 hypertension was reported in 1% of patients [see Warnings and Precautions].

Table 1 shows adverse reactions due to ZYTIGA that occurred with either a ≥ 2% absolute increase in frequency compared to placebo, or were events of special interest (mineralocorticoid excess, cardiac adverse reactions, and liver toxicities).

Table 1: Adverse Reactions due to ZYTIGA in a Placebo-Controlled Phase 3 Trial ZYTIGA with Placebo with Prednisone Prednisone (N=791) (N=394) System/Organ All Grades1 Grade 3-4Class All Grades Grade 3-4 Adverse reaction % % % % Musculoskeletal and connective tissue disorders Joint swelling/discomfort2 29.5 4.2 23.4 4.1 Muscle discomfort3 26.2 3.0 23.1 2.3 General disorders Edema4 26.7 1.9 18.3 0.8 Vascular disorders Hot flush 19.0 0.3 16.8 0.3 Hypertension 8.5 1.3 6.9 0.3 Gastrointestinal disorders Diarrhea 17.6 0.6 13.5 1.3 Dyspepsia 6.1 0 3.3 0 Infections and infestations Urinary tract infection 11.5 2.1 7.1 0.5 Upper respiratory tract infection 5.4 0 2.5 0 Respiratory, thoracic and mediastinal disorders Cough 10.6 0 7.6 0 Renal and urinary disorders Urinary frequency 7.2 0.3 5.1 0.3 Nocturia 6.2 0 4.1 0 Injury, poisoning and procedural complications Fractures5 5.9 1.4 2.3 0 Cardiac disorders 7.2 1.1 4.6 1.0 Arrhythmia6 Chest pain or 7 3.8 0.5 2.8 0 chest discomfort 2.3 1.9 1.0 0.3 Cardiac failure8 1

Adverse events graded according to CTCAE version 3.0 Includes terms Arthritis, Arthralgia, Joint swelling, and Joint stiffness 3 Includes terms Muscle spasms, Musculoskeletal pain, Myalgia, Musculoskeletal discomfort, and Musculoskeletal stiffness 4 Includes 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 2

ZYTIGA® (abiraterone acetate) Tablets

ZYTIGA® (abiraterone acetate) Tablets

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USE IN SPECIFIC POPULATIONS Pregnancy: Pregnancy Category X [see Contraindications]. 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, the patient should be apprised of the potential hazard to the fetus and the potential risk for pregnancy loss. Women of childbearing potential should be advised to avoid becoming pregnant during treatment with ZYTIGA. 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: ZYTIGA is not indicated in children.

Geriatric Use: Of the total number of patients in a phase 3 trial of ZYTIGA, 71% of patients were 65 years and over and 28% were 75 years and over. No overall differences in safety or effectiveness were observed between these elderly patients and younger patients.

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].

OVERDOSAGE: There have been no reports of overdose of ZYTIGA during clinical studies. 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 to 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].

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 Cardiovascular Adverse Reactions: Cardiovascular adverse reactions in the phase 3 trial are shown in Table 1. The majority of arrhythmias were grade 1 or 2. Grade 3-4 arrhythmias occurred at similar rates in the two arms. There was one death associated with arrhythmia and one patient with sudden death in the ZYTIGA arm. No patients had sudden death or arrhythmia associated with death in the placebo arm. Cardiac ischemia or myocardial infarction led to death in 2 patients in the placebo arm and 1 death in the ZYTIGA arm.

Cardiac failure resulting in death occurred in 1 patient on both arms.

Hepatotoxicity: Drug-associated hepatotoxicity with elevated ALT, AST, and total bilirubin has been reported in patients treated with ZYTIGA. Across all clinical trials, liver function test elevations (ALT or AST increases of > 5X ULN) were reported in 2.3% of patients who received ZYTIGA, typically during the first 3 months after starting treatment. In the phase 3 trial, patients whose baseline ALT or AST were elevated were more likely to experience liver function test elevations than those beginning with normal values.

When elevations of either ALT or AST > 5X ULN, or elevations in bilirubin > 3X ULN were observed, ZYTIGA was withheld or discontinued. In two instances marked increases in liver function tests occurred [see Warnings and Precautions]. These two patients with normal baseline hepatic function, experienced ALT or AST elevations 15 to 40X ULN and bilirubin elevations 2 to 6 X ULN. Upon discontinuation of ZYTIGA, both patients had normalization of their liver function tests and one patient was re-treated with ZYTIGA without recurrence of the elevations.

In clinical trials, the following patients were excluded: patients with active hepatitis, patients with baseline ALT and/or AST ≥ 2.5X ULN in the absence of liver metastases, and patients with ALT and/or AST > 5X ULN in the presence of liver metastases. Abnormal liver function tests developing in patients participating in clinical trials were managed by treatment interruption, dose modification and/or discontinuation [see Dosage and Administration (2.2) in full Prescribing Information and Warnings and Precautions]. Patients with elevations of ALT or AST > 20X ULN were not re-treated.

Other Adverse Reactions: Adrenal insufficiency occurred in two patients on the abiraterone arm of the phase 3 clinical trial (< 1%).

Laboratory Abnormalities of Interest: Table 2 shows laboratory values of interest from the phase 3 placebo-controlled clinical trial. Grade 3-4 low serum phosphate (7.2%) and potassium (5.3%) occurred more frequently in the ZYTIGA arm.

Table 2: Laboratory Abnormalities of Interest in a Phase 3 Placebo-Controlled Clinical Trial Abiraterone (N=791) Placebo (N=394) All Grades Grade 3-4 All Grades Grade 3-4 Laboratory Abnormality (%) (%) (%) (%) High Triglyceride 62.5 0.4 53.0 0 High AST 30.6 2.1 36.3 1.5 Low Potassium 28.3 5.3 19.8 1.0 Low Phosphorus 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 DRUG INTERACTIONS 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].

Drugs that Inhibit or Induce CYP3A4 Enzymes: Based on in vitro data, ZYTIGA is a substrate of CYP3A4. The effects of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole) or inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital) on the pharmacokinetics of abiraterone have not been evaluated, in vivo. Avoid or use with caution, strong inhibitors and inducers of CYP3A4 during ZYTIGA treatment [see Clinical Pharmacology (12.3) in full Prescribing Information].

Manufactured by: Patheon Inc. Mississauga, Canada Manufactured for: Janssen Biotech, Inc. Horsham, PA 19044 Issued: December 2011 08Z11205B

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) who have received prior chemotherapy containing docetaxel.

IMPORTANT SAFETY INFORMATION

Please see brief summary of Prescribing Information on adjacent pages.

© Janssen Biotech, Inc. 2012

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Contraindications ZYTIGA® (abiraterone acetate) may cause fetal harm (Pregnancy Category X) 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 hypertension, hypokalemia, and 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 because these patients were excluded from the randomized clinical trial. 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 has been reported in clinical trials 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 Increases in liver enzymes have led to drug interruption, dose modification, and/or discontinuation. 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.

Food Effect ZYTIGA® must be taken on an empty stomach. Exposure of abiraterone increases up to 10-fold when abiraterone acetate is taken with meals. 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 (≥5%) are joint swelling or discomfort, hypokalemia, edema, muscle discomfort, hot flush, diarrhea, urinary tract infection, cough, hypertension, arrhythmia, urinary frequency, nocturia, dyspepsia, fractures and upper respiratory tract infection.

Drug Interactions ZYTIGA® is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6. Avoid co-administration with CYP2D6 substrates that have a narrow therapeutic index. If an alternative cannot be used, exercise caution and consider a dose reduction of the CYP2D6 substrate. Additionally, abiraterone is a substrate of CYP3A4 in vitro. Strong inhibitors and inducers of CYP3A4 should be avoided or used with caution.

Use in Specific Populations The safety of ZYTIGA® in patients with baseline severe hepatic impairment has not been studied. These patients should not receive ZYTIGA®.

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Patient insurance benefit investigation is provided as a service by TheraCom, LLC and The Lash Group, Inc., under contract for Janssen Biotech, Inc. In this regard, TheraCom, LLC, and The Lash Group, Inc., assist 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, TheraCom, LLC, 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 TheraCom, LLC, and The Lash Group, Inc., try to provide correct information, they and Janssen Biotech make no representations or warranties, expressed or implied, as to the accuracy of the information. In no event shall TheraCom, LLC, 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.

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